2024-02092. Saflufenacil; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of saflufenacil in or on corn, field, forage; corn, field, stover; and corn, field, milled byproducts; and amends the existing commodity definition for Crop Group 16 to Crop Group 16–22. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective February 2, 2024. Objections and requests for hearings must be received on or before April 2, 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–2022–0868, 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: [e-mail].

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–2022–0868 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 April 2, 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–2022–0868, 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.

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 2F9019) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.649(a)(1) be amended by establishing tolerances for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on Corn, field, forage at 0.3 parts per million (ppm), Corn, field, milled byproducts at 0.125 ppm, and Corn, field, stover at 5.0 ppm. The petition also requested to amend the existing commodity definition in 40 CFR 180.649(a)(1) for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on “Grain, cereal, forage, fodder and straw group 16 (except barley and wheat straw)” to “Grain, cereal, forage, hay, stover, and straw group 16–22 (except field corn forage, field corn stover, barley straw, wheat straw, and chia straw)” unchanged at 0.1 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, 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 has made modifications to the proposed tolerance values and commodity definitions. 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 tolerances 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 for 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 tolerances 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. A summary of the toxicological points of departure and levels of concern for saflufenacil used for human health risk assessment is discussed in Unit III.B. of the November 25, 2015, rulemaking.

Exposure assessment. Much of the exposure assessment remains unchanged from the November 2015 rulemaking, although updates have occurred to accommodate the exposures from the petitioned-for tolerances. These 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 exposure from the petitioned-for tolerances for saflufenacil. Acute and chronic dietary exposure assessments were performed for saflufenacil that incorporated tolerance-level residues, 100% crop treated (CT) assumptions, and default processing factors. These assessments were revised to reflect the updated Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM–FCID), Version 4.02, which incorporates 2005–2010 consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The acute and chronic estimated drinking water concentrations (EDWCs) of 133 parts per billion (ppb) and 120 ppb, respectively, are unchanged from the November 25, 2015, rulemaking and were directly incorporated into the dietary assessments. A cancer dietary assessment was not conducted as saflufenacil is classified as “not likely” to be a human carcinogen. Saflufenacil is not registered for any specific use patterns that would result in residential exposure. Therefore, a quantitative residential exposure 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.” EPA has not found saflufenacil to share a common mechanism of toxicity with any other substances, and saflufenacil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that saflufenacil 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.

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 (PODs) to ensure that an adequate margin of exposure (MOE) exists.

Acute dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the acute population adjusted dose (aPAD); they are <1% of the aPAD for all infants less than 1 year old, the population group receiving the greatest exposure. Chronic dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the chronic population adjusted dose (cPAD); they are 26% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. 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 only, and as stated above, 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. Human Health Risk Assessment for Proposed New and Amended Uses on Field Corn Commodities, Post-Harvest and Fallow” in docket ID number EPA–HQ–OPP–2022–0868.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (high-performance liquid chromatography with tandem mass spectroscopy detection (HPLC–MS/MS) Method D0603/04) 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: [e-mail].

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 has not established MRLs for saflufenacil for feed items of raw agricultural commodities. Therefore, harmonization of MRLs and U.S. tolerances is not an issue at this time.

C. Revisions to Petitioned-For Tolerances

EPA is revising the tolerance level proposed for corn, field, forage from 0.3 ppm to 0.4 ppm based on field trial residues values and the combined residue calculation. The tolerance level proposed for corn, field, stover is also being revised from 5.0 ppm to 5 ppm based on the Organization for Economic Co-operation and Development (OECD) rounding class practice. EPA is also revising the tolerance level proposed for corn, field, milled byproducts from 0.125 ppm to 0.2 ppm to adjust for degree of exaggeration and the OECD rounding class. Also, EPA is revising the proposed commodity definition “Grain, cereal, forage, hay, stover, and straw group 16–22 (except field corn forage, field corn stover, barley straw, wheat straw, and chia straw)” to the following definitions to align better with the Agency's current preferred commodity vocabulary: “Grain, cereal, forage, hay, stover, and straw, group 16–22, forage, except corn, field, forage”; “Grain, cereal, forage, hay, stover, and straw, group 16–22, hay”; “Grain, cereal, forage, hay, stover, and straw, group 16–22, stover, except corn, field, stover”; and “Grain, cereal, forage, hay, stover, and straw, group 16–22, straw, except barley, chia, and wheat, straw.”

V. Conclusion

Therefore, tolerances are established for residues of saflufenacil, including its metabolites and degradates, in or on Corn, field, forage at 0.4 ppm; Corn, field, milled byproducts at 0.2 ppm; Corn, field, stover at 5 ppm; Grain, cereal, forage, hay, stover, and straw, group 16–22, forage, except corn, field, forage at 0.1 ppm; Grain, cereal, forage, hay, stover, and straw, group 16–22, hay at 0.1 ppm; Grain, cereal, forage, hay, stover, and straw, group 16–22, stover, except corn, field, stover at 0.1 ppm; and Grain, cereal, forage, hay, stover, and straw, group 16–22, straw, except barley, chia, and wheat, straw at 0.1 ppm. In addition, EPA is removing the established tolerance in or on Grain, cereal, forage, fodder and straw group 16 (except barley and wheat straw) at 0.1 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).

List of Subjects in 40 CFR Part 180

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: January 30, 2024.

Charles Smith,

Director, Registration Division, Office of Pesticide Programs.

Therefore, for the reasons stated in the preamble, 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 § 180.649, amend the table in paragraph (a)(1) by:

a. Adding in alphabetical order the entries “Corn, field, forage”; “Corn, field, milled byproducts”; and “Corn, field, stover”.

b. Removing the entry for “Grain, cereal, forage, fodder and straw group 16 (except barley and wheat straw)”.

c. Adding in alphabetical order the entries “Grain, cereal, forage, hay, stover, and straw, group 16–22, forage, except corn, field, forage”; “Grain, cereal, forage, hay, stover, and straw, group 16–22, hay”; “Grain, cereal, forage, hay, stover, and straw, group 16–22, stover, except corn, field, stover”; and “Grain, cereal, forage, hay, stover, and straw, group 16–22, straw, except barley, chia, and wheat, straw”.

The additions read as follows:

§ 180.649

Saflufenacil; tolerances for residues.

(a) * * *

(1) * * *

Commodity	Parts per million
*         *         *         *         *         *         *
Corn, field, forage	0.4
Corn, field, milled byproducts	0.2
Corn, field, stover	5
*         *         *         *         *         *         *
Grain, cereal, forage, hay, stover, and straw, group 16–22, forage, except corn, field, forage	0.1
Grain, cereal, forage, hay, stover, and straw, group 16–22, hay	0.1
Grain, cereal, forage, hay, stover, and straw, group 16–22, stover, except corn, field, stover	0.1
Grain, cereal, forage, hay, stover, and straw, group 16–22, straw, except barley, chia, and wheat, straw	0.1
*         *         *         *         *         *         *

* * * * *