2023-18346. Spinosad; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of spinosad in or on Spice group 26, and Stalk and stem vegetable subgroup 22A. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective August 28, 2023. Objections and requests for hearings must be received on or before October 27, 2023, 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–2022–0386, 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–2022–0386 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 October 27, 2023. 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–2022–0386, 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 January 3, 2023 (88 FR 38) (FRL–9410–08–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 2E8993) by IR–4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to amend 40 CFR part 180 by establishing tolerances for residues of spinosad in or on the raw agricultural commodities Stalk and stem vegetable subgroup 22A at 0.4 parts per million (ppm), and Spice group 26 at 1.7 ppm.

The petition also proposed to remove established tolerances for residues of spinosad in or on the following: Asparagus, and Spice, subgroup 19B, except black pepper.

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 proposed rule.

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 spinosad including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with spinosad 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 spinosad, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to spinosad 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 spinosad, can be found in the document titled “Spinosad and Spinetoram: Human Health Risk Assessment in Support of Proposed Uses on Stalk and Stem Vegetables (22A) and Greenhouse-Grown Cucumbers, Lettuce, Pepper, and Tomato; and Crop Group Conversion for Spice Group 26” (hereinafter “Spinosad and Spinetoram Human Health Risk Assessment”) which is available in the docket for this action at https://www.regulations.gov.

Toxicological profile. For a discussion of the Toxicological Profile of spinosad, see Unit III.A. of the rulemaking published in the Federal Register of September 19, 2019 (84 FR 49195) (FRL–9995–90).

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 spinosad, see Unit III.B. of the September 19, 2019, rulemaking.

Exposure assessment. Much of the exposure assessment remains unchanged from the September 19, 2019, rulemaking, although the new exposure assessment incorporates the additional dietary exposure from the petitioned-for tolerances. Other changes are described below.

A chronic dietary exposure assessment was conducted using 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). Acute and cancer analyses were not conducted as toxicological effects attributable to a single dose were not identified and spinosad is classified as not likely to be carcinogenic. The chronic dietary analysis assumed 100 percent crop treated (PCT), average field-trial residues or tolerance-level residues for crop commodities, average residues from the livestock feeding studies, residue estimates for fish/shellfish, experimental processing factors when available, and modeled drinking water estimates.

Anticipated residue information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Drinking water and non-occupational exposures. The estimated drinking water concentrations (EDWCs) of spinosad have been modified since the last assessment. Based on the Tier I Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW), the EDWCs of spinosad for chronic exposures are estimated to be 38 parts per billion (ppb) for surface water and below the levels of detection for ground water.

Modeled estimates of drinking water concentration were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration value of 38 ppb was used to assess the contribution to drinking water.

There have been no changes to residential exposures since the September 19, 2019, rulemaking. For calculation of aggregate short-term exposure, residential exposure to adults (residential handler exposure from applying spinosad to turf/ornamentals/home garden), children 3 to less than 6 years old (combined post-application inhalation and ingestion of water exposure during recreational swimming), and children 1 to less than 2 years old (post-application exposure resulting from the application of spinosad to turf/ornamentals/home gardens) yield the highest residential short-term exposure and were therefore used in calculation of aggregate exposure.

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 spinosad and any other substances and spinosad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that spinosad has a common mechanism of toxicity with other substances.

Safety factor for infants and children. EPA continues to conclude that there is 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 September 19, 2019, 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.

An acute assessment was not conducted because toxicological effects attributable to a single dose were not identified. Chronic dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the cPAD: they are 73% of the cPAD for children 1 to 2 years old, which is the population subgroup with the highest exposure estimate.

The short-term aggregate risks combine chronic dietary (food and drinking water) and residential exposures. The short-term aggregate risk for adults is an aggregate MOE of 740; for children aged 3 to less than 6, the aggregate MOE is 330; and for children 1 to less than 2 years old, the aggregate MOE is 200. MOEs below 100 are of concern; these MOEs are above 100 and therefore are not of concern. Short-term aggregate risk calculations are protective of the intermediate-term duration of exposure.

Because spinosad is classified as “not likely to be carcinogenic to humans”, EPA has concluded that aggregate exposure to spinosad 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 spinosad residues. More detailed information about the Agency's analysis can be found at https://www.regulations.gov in the Spinosad and Spinetoram Human Health Risk Assessment in docket ID EPA–HQ–OPP–2022–0386.

IV. Other Considerations

A. Analytical Enforcement Methodology

For a discussion of the available analytical enforcement method, see Unit IV.A. of the September 19, 2019, 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 currently no established Codex MRLs for residues of spinosad in or on Stalk and stem vegetable subgroup 22A or Spice Group 26.

V. Conclusion

Therefore, tolerances are established for residues of spinosad in or on Spice group 26 at 1.7 ppm, and Stalk and stem vegetable subgroup 22A at 0.4 ppm.

Additionally, the established tolerances on Asparagus, and Spice, subgroup 19B, except black pepper, 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

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

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

Dated: August 21, 2023.

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 § 180.495, amend Table 1 to paragraph (a) by:

a. Removing the commodity “Asparagus”.

b. Adding the commodity “Spice group 26”.

c. Removing the commodity “Spice, subgroup 19B, except black pepper”; and

d. Adding the commodity “Stalk and stem vegetable subgroup 22A”.

The additions read as follows:

§ 180.495

Spinosad; tolerances for residues.

* * * * *

Table 1 to Paragraph (a)

Commodity	Parts per million
*    *    *    *    *
Spice group 26	1.7
Stalk and stem vegetable subgroup 22A	0.4
*    *    *    *    *

* * * * *