Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Fatty acids, C16 18 and C18 unsatd., esters with polyethylene glycol mono Me ether in Pesticide Formulations

Fatty acids, C

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 40 CFR part 180 through the Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.

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-2023-0368 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 January 31, 2025. 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-2023-0368, 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#express.

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

II. Petition for Exemption

In the Federal Register of September 19, 2023 (88 FR 64398, FRL-10579-08), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11755) by Spring Regulatory Sciences (6620 Cypresswood Dr., Suite 250, Spring, TX 77379) on behalf of Sasol Chemicals (USA) LLC (12120 Wickchester Lane, Houston, TX 77224). The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether (CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant and related adjuvant of surfactant) in pesticide formulations applied to growing crops or raw agricultural commodities pre- and post-harvest limited to 25% by weight in pesticide formulations. That document referenced a summary of the petition prepared by Spring Regulatory Sciences on behalf of Sasol Chemicals (USA) LLC, the petitioner, which is available in the docket at https://www.regulations.gov. There were no comments received in response to the notice of filing.

III. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term "inert" is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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(c)(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. FFDCA section 408(c)(2)(B) directs EPA to take into account the considerations in section 408(b)(2)(C) and (D) when making a safety determination for an exemption from the requirement of a tolerance. 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 . . . " Section 408(b)(2)(D) lists other factors for EPA consideration when making safety determinations, including the validity, completeness, and reliability of available data, nature of toxic effects, available information concerning the cumulative effects of the pesticide chemical and other substances with a common mechanism of toxicity, and available information concerning aggregate exposure levels to the pesticide chemical and other related substances.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered their 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 adverse effects caused by fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The toxicological database of fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether is supported by data regarding methyl laurate and alcohol ethoxylates (C ₁₂ AE ₇ , C ₁₃ AE ₃ , C ₁₄ AE ₃ , C ₁₄ AE ₇ , C ₁₄ AE ₁₂ , C ₁₅ AE ₃ and C ₁₅ AE ₇ ). EPA has determined that it is appropriate to bridge methyl laurate and the aforementioned alcohol ethoxylates data to assess fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether based on similarities in the functional groups/structure, composition, and physical/chemical properties.

Fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me exhibits low levels of acute toxicity via the oral, dermal, and inhalation routes of exposure. It is not a skin irritant or a skin sensitizer, but it is minimally irritating to the eyes. Reduced body weight starting at 250 mg/kg/day was observed in the combined reproduction and developmental toxicity test, 2-generation reproduction toxicity, and chronic/carcinogenicity studies. Increased offspring susceptibility was observed in the two-generation reproduction toxicity study in rats. Reduced body weight in pups was observed at 250 mg/kg/day in the absence of maternal toxicity. However, the concern for offspring susceptibility is low because the established chronic reference dose (cRfD, 1.6 mg/kg/day) will be protective of offspring effects observed at 250 mg/kg/day. No effects on reproductive parameters, neurotoxicity or immunotoxicity were observed in the available studies. Concern for carcinogenicity is low, based on no evidence of tumors or cancer in chronic/carcinogenicity studies and negative results in mutagenicity studies.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level-generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)-and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.

An acute dietary endpoint was not selected because no effect attributable to a single dose was identified in the database. Co-critical chronic/carcinogenicity studies in rats were selected for the chronic dietary exposure scenario as well as short- and intermediate-term incidental oral, dermal and inhalation exposure scenarios. The NOAEL of 160 mg/kg/day and LOAEL of 250 mg/kg/day, based on decreased body weight, are selected for risk assessment. The studies are appropriate for the duration of exposure, protective of all subchronic effects, protective of the general population, and are protective of the most sensitive lifestage (children). The standard inter- and intra-species uncertainty factors of 10x are applied (total uncertainty factor = 100x). A dermal absorption factor of 20% is applied. The default factor of 100% is applied for the inhalation absorption rate.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether, EPA considered exposure under the proposed exemption from the requirement of a tolerance. There are no known non-pesticidal dietary exposures for fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether. EPA assessed dietary exposures from fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether in food as follows:

In conducting the dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 4.02, EPA used food consumption information from the U.S. Department of Agriculture's (USDA's) 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum titled "Update to D361707: Dietary Exposure and Risk Assessments for the Inerts." (12/21/2021) and can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2018-0090.

In the dietary exposure assessments, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest levels of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentrations of active ingredient in agricultural products are generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient. In the case of fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether, EPA made a specific adjustment to the dietary exposure assessment to account for the use limitations of the amount of fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether that may be in pesticide formulations (limited to no more than 25%) present at the maximum limitation rather than at equal quantities with the active ingredient.

For the purpose of the screening level dietary risk assessment, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether.

2. From non-dietary exposure. The term "residential exposure" is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

Fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether may be used as an inert ingredient in pesticide products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home. Therefore, screening level residential handler and post-application risk assessments have been performed for common residential exposure scenarios, using assumptions detailed in the 2012 Residential SOPs (available at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide ).

3. Cumulative effects from substances with a common mechanism of toxicity. 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 fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether to share a common mechanism of toxicity with any other substances, and fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether 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.

D. Additional Safety Factor for the Protection of Infants and Children

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) safety factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

Based on the evaluation of available toxicity studies, there is low concern for pre- and postnatal susceptibility from exposure to fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether. The FQPA safety factor has been reduced to 1X because: (1) the toxicity database is adequate to characterize potential pre- and postnatal risk; (2) the established PoD (160 mg/kg/day) will be protective of the body weight decrease in offspring seen at 250 mg/kg/day in the 2-generation reproduction toxicity study in rats; (3) no evidence of neurotoxicity was observed in the database; and (4) the assumptions for the exposure assessment are conservative and unlikely to underestimate risk.

E. 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 PAD (aPAD) and chronic PAD (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 PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether from food and water will utilize approximately 8.9% and 32.3% of the cPAD for the U.S. population and children 1-2 years old (the most highly exposed populations).

3. Short- and intermediate term risks. Short- and intermediate term aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposures to food and water (considered to be a background exposure level).

Fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether may be used as an inert ingredient in pesticide products that are registered for uses 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 fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether.

Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in an aggregate margin of exposure (MOE) of 268 for adults. Adult residential exposure combines high end dermal and inhalation handler exposure from aerosol spray/trigger pump with a high-end post application dermal exposure from contact with treated lawns. The combined short- and intermediate-term aggregated food, water, and residential pesticide exposures result in an aggregate MOE of 127 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). Because EPA's level of concern for fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether is an MOE of 100 or below, these MOEs are not of concern.

V. Other Considerations

Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether in or on any food commodities. EPA is establishing a limitation on the amount of fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether that may be used in pesticide formulations applied pre- and post-harvest. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for food use that exceeds 25% fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether in the final pesticide formulations to be applied pre- and post-harvest.

VI. Conclusions

Therefore, an exemption from the requirement of a tolerance is established for residues of fatty acids, C _16-18 and C ₁₈ -unsatd., esters with polyethylene glycol mono-Me ether (CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant and related adjuvant of surfactant) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910, limited to a maximum concentration of 25% in a pesticide formulation.

VII. Statutory and Executive Order Reviews

This action establishes an exemption from the requirement of a tolerance 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, titled "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, titled "Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use" (66 FR 28355, May 22, 2001) or Executive Order 13045, titled "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, titled "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 exemption 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, titled "Federalism" (64 FR 43255, August 10, 1999) and Executive Order 13175, titled "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).

VIII. 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, the EPA amends 40 CFR chapter I as follows:

PART 180-TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

[FR Doc. 2024-28080 Filed 11-29-24; 8:45 am]

BILLING CODE 6560-50-P