Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Saflufenacil

Saflufenacil; Pesticide Tolerances

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/chapter-I/subchapter-E/part-180.

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-2023-0080, 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 November 8, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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/rhc/epaadmin.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-2023-0080, 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 July 5, 2023 (88 FR 42935) (FRL-10579-05-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 2E9045) 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 180.649 be amended to establish tolerances for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on Barley subgroup 15-22B at 1 parts per million (ppm); Edible-podded bean subgroup 6-22A at 0.03 ppm; Edible-podded pea subgroup 6-22B at 0.03 ppm; Field corn subgroup 15-22C at 0.03 ppm; Forage and hay of legumes vegetable group 7-22 (except pea, hay) at 0.1 ppm; Forage, hay, stover, and straw of cereal grains group 16-22 (except barley and wheat and chia straw) at 0.1 ppm; Fruit, citrus group 10-10 at 0.03 ppm; Fruit, pome group 11-10 at 0.03 ppm; Fruit, stone group 12-12 at 0.03 ppm; Grain sorghum and millet subgroup 15-22E at 0.03 ppm; Mint, dried leaves at 0.04 ppm; Mint, fresh leaves at 0.04 ppm; Nut, tree, group 14-12 at 0.03 ppm; Pulses, dried shelled bean, except soybean, subgroup 6-22E at 0.3 ppm; Pulses, dried shelled pea subgroup 6-22F at 0.3 ppm; Rapeseed 20A at 0.6 ppm; Rice subgroup 15-22F at 0.03 ppm; Succulent shelled bean subgroup 6-22C at 0.03 ppm; Succulent shelled pea subgroup 6-22D at 0.03 ppm; Sweet corn subgroup 15-22D at 0.03 ppm; and Wheat subgroup 15-22A at 0.7 ppm.

Upon the establishment of the tolerances requested above, the petitioner requested that EPA amend 40 CFR 180.649 by removing the tolerances for residues of saflufenacil in or on Barley, grain at 1.0 ppm; Chia, seed at 0.6 ppm; Rapeseed subgroup 20A at 0.45 ppm (identified in the July 5, 2023, Federal Register as "crop subgroup 20A; rapeseed subgroup at 0.45 ppm); Fruit, citrus, group 10 at 0.03 ppm (identified in the July 5, 2023, Federal Register as "Fruit, pome, group 10 at 0.03 ppm); Fruit, pome, group 11 at 0.03 ppm; Fruit, stone, group 12 at 0.03 ppm; Grain, cereal, group 15 (except barley and wheat grain) at 0.03 ppm; Nut, tree, group 14 at 0.03 ppm; Pea and bean, dried shelled, except soybean, subgroup 6C at 0.30 ppm; Pea and bean, succulent shelled, subgroup 6B at 0.03 ppm; Pistachio at 0.03 ppm; Vegetable, foliage of legume, group 7 (except pea, hay) at 0.10 ppm; Vegetable, legume, edible podded, subgroup 6A at 0.03 ppm; and Wheat, grain at 0.60 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.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing the tolerance for residues of saflufenacil in or on mint at a different level than requested by the petitioner. Additionally, EPA is not establishing some of the petitioned-for tolerances because the request was subsequently withdrawn by the petitioner. 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 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 saflufenacil including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with saflufenacil 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 tolerance rulemaking in 2015, for saflufenacil in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to saflufenacil and established a tolerance for residues of that chemical. EPA is incorporating previously published sections from that rulemaking as described further in this rulemaking, as they remain unchanged.

Toxicological profile. For a discussion of the toxicological profile for saflufenacil, see Unit III.A. of the saflufenacil tolerance rulemaking published in the Federal Register of November 25, 2015 (80 FR 73663) (FRL-9936-71).

Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern for saflufenacil used for human health risk assessment, see Unit III.B. of the November 25, 2015, rulemaking.

Exposure assessment. Much of the exposure assessment remains unchanged from the November 2015, rulemaking, except as described below. The updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, see Unit III.C of the November 25, 2015, rulemaking.

EPA's dietary exposure assessments have been updated to include the additional exposures from the uses associated with the tolerances established since the November 25, 2015, rulemaking and the additional exposure from the new use of saflufenacil on mint and the crop group conversions to fruit, citrus, group 10-10; fruit, pome, group 11-10; fruit, stone, group 12-12; and nut, tree, group 14-12. The dietary exposure assessments were conducted with Dietary Exposure Evaluation Model software using the Food Commodity Intake Database (DEEM-FCID), Version 4.02, which uses the 2005-2010 food consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The assessment used the same assumptions as the November 25, 2015, final rule concerning tolerance-level residues, default processing factors for all processed commodities, and 100 percent crop treated.

Drinking water exposure. The drinking water numbers have not changed since the November 25, 2015, rulemaking.

Non-occupational exposure. There are no residential (non-occupational) uses proposed or currently registered for saflufenacil. Therefore, a residential risk assessment was not conducted.

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 saflufenacil and any other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that saflufenacil has a common mechanism of toxicity with other substances.

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 November 25, 2015, 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.

Acute dietary risks are below the Agency's level of concern of 100% of the aPAD; they are less than 1% of the aPAD for all infants (less than 1 year old), the population subgroup with the highest exposure estimate. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 26% of the cPAD for all infants (less than 1 year old), the population group with the highest exposure estimate. There is no short- or intermediate-term residential exposure expected since there are no proposed or previously registered residential uses of saflufenacil. Therefore, the acute and chronic aggregate risks consist only of the dietary risks from food and water, and as stated above, these are below the Agency's level of concern. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, saflufenacil is not expected to pose a cancer risk to humans.

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 saflufenacil 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 "Saflufenacil. Section 3 Human Health Risk Assessment for Proposed New Uses on Mint (Peppermint and Spearmint) and Crop Group Conversions and Expansions" in docket ID number EPA-HQ-OPP-2023-0080.

IV. Other Considerations

A. Analytical Enforcement Methodology

For a discussion of the available analytical enforcement method, see Unit IV.A. of the February 2, 2024, rulemaking (89 FR 7291) (FRL-11673-01-OCSPP).

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 an MRL for residues of saflufenacil in or on mint. The Codex has established MRLs for saflufenacil in or on Fruit, citrus, group 10-10 at 0.01 ppm; Fruit, pome, group 11-10 at 0.01 ppm; Fruit, stone, group 12-12 at 0.01 ppm; and Nut, tree, group 14-12 at 0.01 ppm. The U.S. tolerance levels are not harmonized with these Codex commodity MRLs. Based on available residue data, use by U.S. growers consistent with approved label instructions would result in residues that exceed the Codex MRL. Harmonizing with these Codex MRLs could put U.S. growers at risk of violative residues despite legal use of saflufenacil according to the label.

C. Revisions to Petitioned-For Tolerances

EPA is establishing the tolerance for residues of saflufenacil in or on mint at 0.03 ppm instead of the petitioner-proposed 0.04 ppm. As discussed in the Human Health Risk Assessment, the petitioner's proposed tolerance of 0.04 ppm includes the parent compound and three metabolites. However, since EPA determined that the tolerance expression should only include the parent compound and two metabolites, the residue calculation was corrected to reflect these residues.

EPA is not establishing some of the petitioned-for tolerances because the petitioner withdrew the requests for tolerances of residues of saflufenacil in or on Barley subgroup 15-22B; Edible-podded bean subgroup 6-22A; Edible-podded pea subgroup 6-22B; Field corn subgroup 15-22C; Forage and hay of legume vegetable group 7-22 (except pea, hay); Forage, hay, stover and straw of cereal grain group 6-22 (except barley, chia, and wheat straw); Grain sorghum and millet subgroup 15-22E; Pulses, dried shelled bean, except soybean, subgroup 6-22E; Pulses, dried shelled pea, subgroup 6-22F; Rapeseed subgroup 20A; Rice subgroup 15-22F; Succulent shelled pea subgroup 6-22C; Succulent shelled pea subgroup 6-22D; Sweet corn subgroup 15-22D and Wheat subgroup 15-22A. Therefore, EPA is not establishing these tolerances or removing the related tolerances as requested by IR-4.

V. Conclusion

Therefore, tolerances are established for residues of saflufenacil, including its metabolites and degradates, in or on Fruit, citrus, group 10-10 at 0.03 ppm; Fruit, pome, group 11-10 at 0.03 ppm; Fruit, stone, group 12-12 at 0.03 ppm; Mint, dried leaves at 0.03 ppm; Mint fresh leaves at 0.03 ppm; and Nut, tree, group 14-12 at 0.03 ppm. Upon the establishment of these tolerances, EPA is removing tolerances for residues of saflufenacil, including its metabolites and degradates, in or on fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; and pistachio.

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).

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