Pendimethalin; Pesticide Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of pendimethalin in or on fig and fig, dried. BASF Corporation has requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective July 31, 2024. Objections and requests for hearings must be received on or before September 30, 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-2023-0308, 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 for the OPP Docket is (202) 566-1744. Please review the visitor instructions and additional information about the docket available at 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-2023-0308, 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 September 30, 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-2023-0308, 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.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

• 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.

II. Summary of Petitioned-For Tolerance

In the Federal Register of December 19, 2023 (88 FR 87733) (FRL-10579-11), 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 2F9038) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide pendimethalin, including its metabolites and degradates, in or on the raw agricultural commodities fig at 0.1 parts per million (ppm) and fig, dried at 3.0 ppm. That document referenced a summary of the petition prepared by BASF, the registrant, which is available in the docket at https://www.regulations.gov.

The December 19, 2023, notice of filing supersedes a notice of filing published in the Federal Register of July 26, 2023 (88 FR 48179) (FRL-10579-06), which was based on an earlier version of the same petition (2F9038) requesting tolerances for tropical and subtropical fruit, medium to large fruit, edible peel subgroup 23B at 0.1 ppm and fig, dried fruit at 3.0 ppm; and an inadvertent tolerance for cilantro, fresh leaves at 0.1 ppm. Following that July 2023 publication, BASF amended its petition to request tolerances only for fig and fig, dried, as noticed in the December 2023 publication.

No comments were received in response to the December 19, 2023, and the July 26, 2023, notices 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 modified the level at which one of the tolerances is being established. The reason for this change is explained in Unit IV.D.

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 pendimethalin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pendimethalin 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.

In the Federal Register of February 16, 2018 (83 FR 6975) (FRL-9973-03) and October 25, 2019 (84 FR 57336) (FRL-10000-06), EPA published tolerance rulemakings for pendimethalin in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to pendimethalin and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological profile. For a discussion of the Toxicological Profile of pendimethalin, see Unit III.A. of the October 25, 2019, rulemaking.

Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern for pendimethalin used for human health risk assessment, please reference Unit III.B. of the February 16, 2018, rulemaking.

Exposure assessment. Much of the exposure assessment for pendimethalin remains unchanged from the discussion in Unit III.C. of the October 25, 2019, rulemaking, except as described below.

Dietary exposure from food and feed uses. EPA's dietary exposure assessments have been updated to include the additional exposure from the proposed new uses on fresh and dried fig. The acute and chronic dietary (food and drinking water) exposure assessments in support of the proposed fresh and dried fig uses 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 United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The unrefined acute and chronic dietary exposure assessments assumed 100 percent crop treated (PCT), tolerance-level residues for all crops, and maximum anticipated residues to address all residues of concern in ruminant commodities.

Drinking water and non-occupational exposures. The drinking water numbers have not changed as a result of the proposed fresh and dried fig uses. For a detailed summary of the drinking water analysis for pendimethalin used for the human health risk assessment, please reference Unit III.C.2. of the October 25, 2019, rulemaking.

There are no residential exposures expected from the currently proposed uses; however, pendimethalin is currently registered for residential usage on gardens, golf course turf, lawns, and ornamentals. The highest anticipated short-term aggregate exposure scenarios for children and adults did not present risks of concern ( i.e., margins of exposure (MOEs) are > the level of concern (LOC) of 30). Intermediate-term exposures to pendimethalin are not likely because of the intermittent nature of applications by homeowners ( e.g., garden sprays). Long-term aggregate exposure is not anticipated for residential uses.

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 The Agency has utilized this framework for pendimethalin and determined that although pendimethalin 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 pendimethalin, and other pesticides and no further cumulative evaluation is necessary for pendimethalin.

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 October 25, 2019, 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 aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure (PODs) to ensure that an adequate MOE exists.

The results of the acute dietary analysis for food and drinking water at the 95th percentile of exposure shows that the acute dietary risk estimates are below the Agency's level of concern (<100% of the aPAD) for all population subgroups and were estimated at <1% of the aPAD for the U.S. general population and 2.1% of the aPAD for the most highly exposed population subgroup (infants <1 years old). The results of the chronic dietary analysis for food and drinking water indicate that the chronic dietary risk estimates are below the Agency's level of concern (<100% of the cPAD) for all population subgroups and were estimated at <1% of the cPAD for the U.S. general population and 2.3% of the cPAD for the most highly exposed population subgroup (children 1 to 2 years old).

Acute aggregate exposure is anticipated to occur from dietary exposure in food and drinking water only. There are no risks of concern for acute dietary exposure and thus no risks of concern for acute aggregate exposure. Short-term aggregate risk assessment was performed since there is potential for post-application exposure from the existing uses in residential settings. The highest anticipated short-term aggregate exposure scenarios for children and adults did not present risks of concern ( i.e., MOEs are >LOC of 30). Intermediate-term exposures to pendimethalin are not likely because of the intermittent nature of applications by homeowners ( e.g., garden sprays). Long-term aggregate exposure is not anticipated for residential uses. Therefore, chronic aggregate risk estimates for pendimethalin include food and drinking water only, and are equivalent to the chronic dietary risk estimates, and are below HED's LOC. Pendimethalin is classified as a “possible human carcinogen.” However, the chronic dietary risk assessment is considered to be protective of any cancer effects; therefore, a separate quantitative cancer dietary risk assessment is not required. The chronic reference dose (cRfD)/cPAD is considered to be protective of all chronic toxicity, including carcinogenicity, that could result from exposure to pendimethalin. Since there are no chronic aggregate risks of concern, there are no cancer aggregate risks 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 pendimethalin residues. More detailed information on the subject action to establish tolerances in or on fig commodities can be found in the document titled “Pendimethalin—Human Health Risk Assessment to Support the Proposed New Use on Fig.” available at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2023-0308.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate analytical enforcement methodology, gas chromatography with electron capture detection (GC/ECD), 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: residuemethods@epa.gov.

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 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 any MRLs for pendimethalin for the crops covered by this action.

C. Revisions to Petitioned-For Tolerances

EPA is establishing the tolerance for fig, dried at 3 ppm rather than 3.0 ppm to be consistent with Organisation for Economic Cooperation and Development (OECD) rounding class practices.

V. Conclusion

Therefore, tolerances are established for residues of pendimethalin in or on the raw agricultural commodities fig at 0.1 parts per million (ppm) and fig, dried at 3 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 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).

List of Subjects in 40 CFR Part 180

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

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

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

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

2. In § 180.361, amend paragraph (a)(1) by designating the table as “Table 1 to Paragraph (a)(1)” and adding to newly designated table 1, in alphabetical order, the entries “Fig” and “Fig, dried” to read as follows: