2023-10709. Benzyl Alcohol; Exemption From the Requirement of a Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes an exemption from the requirement of a tolerance for residues of benzyl alcohol (CAS Reg. No. 100–51–6) when used as an inert ingredient (adjuvant) in pesticide formulations applied to crops and raw agricultural commodities pre- and post-harvest, limited to no more than 60% by weight in the pesticide formulation. Landis International, Inc., on behalf of CJB Applied Technologies, LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of benzyl alcohol when used in accordance with the terms of the exemption.

DATES:

This regulation is effective May 19, 2023. Objections and requests for hearings must be received on or before July 18, 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–2021–0173, 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 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 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–2021–0173 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 July 18, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although the Office of the Administrative Law Judges, which houses the Hearing Clerk, encourages parties to file objections and hearing requests electronically. See https://www.epa.gov/​sites/​default/​files/​2020-05/​documents/​2020-04-10_​-_​order_​urging_​electronic_​service_​and_​filing.pdf.

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–2021–0173, 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. Petition for Exemption

In the Federal Register of March 24, 2023 (88 FR 17778) (FRL–10579–02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–11504) by Landis International, Inc., 3185 Madison Highway, Valdosta, GA 31603, on behalf of CJB Applied Technologies, LLC, 1105 Innovation Way, P.O. Box 5724, Valdosta, GA 31603. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of benzyl alcohol (CAS Reg. No. 100–51–6) when used as an inert ingredient (adjuvant) in pesticide formulations applied to crops and raw agricultural commodities pre- and post-harvest, limited to no more than 60% by weight in the pesticide formulation. That document referenced a summary of the petition prepared by Landis International, Inc., on behalf of CJB Applied Technologies, LLC, which is available in the docket, 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. 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 or exemption 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 . . . .”

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 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 to benzyl alcohol, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with benzyl alcohol 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 benzyl alcohol 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.

Benzyl alcohol exhibits low acute oral and inhalation toxicity, while acute dermal toxicity is moderate. Benzyl alcohol shows none to weakly irritating properties to the skin, but it is not a skin sensitizer.

Based on the available repeated-dose toxicity data on benzyl alcohol, the central nervous system is a major target organ in rats and mice. In rats, mortality, staggering, labored breathing, lethargy, and necrosis of the denta gyrus of the hippocampus are seen at 800 mg/kg/day following dosing in a 13-week oral toxicity study via gavage. In mice, lethargy is seen at 500 mg/kg/day and staggering at 800 mg/kg/day following dosing in a 16-day and 13-week oral toxicity study via gavage, respectively. Maternal (mortality, reduced body weights, clinical signs of neurotoxicity) and offspring (reduced bodyweight) toxicity are seen in mice at 750 mg/kg/day in a developmental toxicity study. No adverse effects are seen in rats at 750 mg/kg/day in a developmental toxicity study. Due to the neurotoxic effects seen following dosing in the 13-week oral toxicity studies in rats and mice at 800 mg/kg/day, the highest doses tested in the chronic/carcinogenicity studies were 400 and 200 mg/kg/day for rats and mice, respectively. No systemic toxicity or treatment related tumors were seen in rats or mice at these doses.

Neurotoxicity studies are not available for review. However, signs of neurotoxicity are seen in mice (lethargy) at 500 mg/kg/day following dosing in a 16-day oral toxicity study and in rats (staggering, labored breathing, lethargy, necrosis of the denta gyrus of the hippocampus) and mice (staggering) at 800 mg/kg/day in a 13-week oral toxicity study via gavage. However, clear NOAELs were established for these effects and the acute population adjusted dose (aPAD) of 4 mg/kg/day and the chronic population adjusted dose (cPAD) of 2 mg/kg/day are protective of the neurotoxic effects observed at 500 mg/kg/day and 800 mg/kg/day in the rat and mouse, respectively. Therefore, there is no concern for neurotoxicity.

Immunotoxicity studies are not available for review. Thymic congestion, hemorrhage, and atrophy were observed at 800 mg/kg/day in rats in a 13-week oral toxicity study via gavage. However, a clear NOAEL was established for these effects and the cPAD (2 mg/kg/day) is protective of the immunotoxic effects observed at 800 mg/kg/day. Therefore, there is no concern for immunotoxicity.

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.

A summary of the toxicological endpoints for benzyl alcohol used for human health risk assessment is shown in Table 1 of this unit.

Table 1—Summary of Toxicological Doses and Endpoints for Benzyl Alcohol for Use in Human Health Risk Assessment

Exposure/scenario	Point of departure and uncertainty/safety factors	RfD, PAD, LOC for risk assessment	Study and toxicological effects
Acute dietary (General population including infants and children)	NOAEL = 400 mg/kg/day UF A = 10x UF H = 10x FQPA SF = 1x	Acute RfD = 4.00 mg/kg/day aPAD = 4.0 mg/kg/day	13-week oral toxicity—Rat LOAEL = 800 mg/kg/day based on clinical signs of neurotoxicity after a single dose.
Chronic dietary (All populations)	NOAEL= 250 mg/kg/day UF A = 10x UF H = 10x FQPA SF = 1x	Chronic RfD = 2.0 mg/kg/day cPAD = 2.0 mg/kg/day	16-day oral toxicity—Mouse LOAEL = 500 mg/kg/day based on lethargy.
Incidental oral short- and intermediate-term (1 to 30 days and 1 to 6 months)	NOAEL= 250 mg/kg/day UF A = 10x UF H = 10x FQPA SF = 1x	LOC for MOE = 100	16-day oral toxicity—Mouse LOAEL = 500 mg/kg/day based on lethargy.
Dermal short- and intermediate-term (1 to 30 days and 1 to 6 months)	NOAEL = 250 mg/kg/day (dermal absorption rate = 100%) UF A = 10x UF H = 10x FQPA SF = 1x	LOC for MOE = 100	16-day oral toxicity—Mouse LOAEL = 500 mg/kg/day based on lethargy.
Inhalation short- and intermediate-term (1 to 30 days and 1 to 6 months)	Inhalation study NOAEL= 1,072 mg/m3 (~328 mg/kg/day) (inhalation absorption rate = 100%) UF A = 10x UF H = 10x FQPA SF = 1x	LOC for MOE = 100	4-week inhalation toxicity study—Rat LOAEL was not established.
Cancer (Oral, dermal, inhalation)	Benzyl alcohol is not expected to be carcinogenic, based on available data for benzyl alcohol in rats and mice, and a cancer dietary exposure assessment was not performed.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to benzyl alcohol, EPA considered exposure that may occur from the existing and proposed uses of benzyl alcohol. EPA assessed dietary exposures from benzyl alcohol in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring after a single exposure. Such effects were identified for benzyl alcohol. Acute dietary (food only) exposure and risk assessments 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 U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The current assessment includes every commodity available in DEEM.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment using DEEM–FCID, Version 4.02, EPA used food consumption information from USDA's 2005–2010 NHANES/WWEIA. As to residue levels in food, no residue data were submitted for benzyl alcohol. 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 entitled “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 assessment, 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. However, to account for the proposed uses of benzyl alcohol up to 60% by weight in pesticide formulations, EPA assumed a 60% concentration of benzyl alcohol in the dietary exposure assessment.

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. Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for benzyl alcohol, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. 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, for lawn and garden pest control, indoor pest control, termiticides, flea and tick control on pets and hard surface disinfection on walls, floors, tables).

Benzyl alcohol is currently approved for use as an inert ingredient in antimicrobial pesticides and nonfood use pesticides ( e.g., pet spot-on treatments; products used on lawn, turf, or gardens) that could result in short-term residential exposure. Although benzyl alcohol is approved as an active ingredient, currently there are no active registrations for its use as an active ingredient. Short-term residential exposure for adults combines high-end dermal and inhalation handler exposure from indoor hard surface, aerosol sprays with high-end post-application dermal exposure from contact with treated lawns and results in an MOE of 161. Short-term residential exposure for children includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures) and results in an MOE of 540. Because EPA's level of concern (LOC) for benzyl alcohol is an MOE below 100, these MOEs are not of concern.

Intermediate-term residential exposure for adults includes high-end post-application dermal exposure from contact with treated lawns and results in an MOE of 3800. Intermediate-term residential exposure for children includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures) and results in an MOE of 2,000. Because EPA's LOC for benzyl alcohol is an MOE below 100, these MOEs are not of concern.

Benzyl alcohol is also used in products such as cosmetics and personal care products that could result in short-, intermediate- and long-term exposures. The International Fragrance Association calculated a dermal exposure of 0.042 mg/kg/day using the reported 97.5th percentile concentration based on the levels of the same fragrance ingredient in ten of the most frequently used personal care and cosmetic products ( i.e., anti-perspirant, bath products, body lotion, eau de toilette, face cream, fragrance cream, hair spray, shampoo, shower gel, and toilet soap). An inhalation exposure level of 0.0026 mg/kg/day was calculated based on the combined (fine fragrances, hair sprays, antiperspirants/deodorants, candles, aerosol air fresheners, and reed diffusers/heated oil plug-ins) result calculated using the Research Institute for Fragrance Material, Inc. (RIFM) 2-Box/MPPD in silico models, based on the International Fragrance Association (IFRA) survey results for the 97.5th percentile use in hydro alcoholics for a 60 kg individual. Total systemic exposure due to use in cosmetics and personal care products is 0.0446 mg/kg/day. The MOE is 5605. Because EPA's LOC for benzyl alcohol is an MOE below 100, this MOE is not of concern.

4. 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 benzyl alcohol to share a common mechanism of toxicity with any other substances, and benzyl alcohol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that benzyl alcohol 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. Safety Factor for Infants and Children

In general. 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 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.

The Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1X for the following reasons. The toxicity database for benzyl alcohol is adequate, it contains developmental toxicity studies in the mouse and a four-generation reproduction toxicity study in the rat. No fetal susceptibility or reproduction toxicity is observed in these studies. Lethargy is observed in mice at 500 mg/ kg/day following dosing in a 16-day oral toxicity study. In a 13-week oral toxicity study, staggering, labored breathing, lethargy, and necrosis of the denta gyrus of the hippocampus were observed in rats, and staggering was observed in mice at 800 mg/kg/day. Thymic congestion, hemorrhage, and atrophy were observed in rats at 800 mg/kg/day in a 13-week oral toxicity study. However, clear NOAELs were established for these effects and the selected points of departure (PODs) are based on the neurological effects observed at 500 mg/kg/day and are protective of the immunological effects observed at 800 mg/kg/day. Therefore, there is no concern for potential neurotoxicity or immunotoxicity. Based on the adequacy of the toxicity database, the conservative nature of the exposure assessment and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1x.

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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to benzyl alcohol will occupy 74% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

2. Chronic risk. A chronic aggregate risk assessment takes into account chronic exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to benzyl alcohol from food and water will utilize 61% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

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

Benzyl alcohol 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 benzyl alcohol.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short-term aggregated food, water, and residential pesticide and non-pesticide exposures result in an aggregate MOE of 112 for adults. Adult residential pesticide exposure combines high-end dermal and inhalation handler exposure from indoor hard surface aerosol spray with high-end post-application dermal exposure from contact with treated lawns. EPA has concluded the combined short-term aggregated food, water, and residential pesticide and non-pesticide exposures result in an aggregate MOE of 123 for children. Children's residential pesticide exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). Because EPA's LOC for benzyl alcohol is an MOE below 100, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Benzyl alcohol may be used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to benzyl alcohol.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 337 for adults. Adult residential pesticide exposure combines high-end dermal and inhalation handler exposure from indoor hard surface aerosol spray with a high-end post-application dermal exposure from contact with treated lawns. EPA has concluded the combined intermediate-term aggregated food, water, and residential pesticide and non-pesticide exposures result in an aggregate MOE of 147 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). Because EPA's LOC for benzyl alcohol is an MOE below 100, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in adequate rodent carcinogenicity studies, benzyl alcohol is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on the risk assessments and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to benzyl alcohol residues. More detailed information on this action can be found in the document titled “Benzyl Alcohol Human Health Risk Assessment and Ecological Effects Assessment to Support an Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations” in docket ID EPA–HQ–OPP–2021–0173.

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 benzyl alcohol in or on any food commodities. EPA is establishing a limitation on the amount of benzyl alcohol that may be used in pesticide formulations. 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 60% benzyl alcohol in the final pesticide formulation.

VI. Conclusions

Therefore, an exemption from the requirement of a tolerance is established for residues of benzyl alcohol (CAS Reg. No. 100–51–6) when used as an inert ingredient (adjuvant) in pesticide formulations applied to crops and raw agricultural commodities pre- and post-harvest under 40 CFR 180.910, limited to no more than 60% by weight in the pesticide formulation.

VII. Statutory and Executive Order Reviews

This action establishes a tolerance exemption 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 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, 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).

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).

List of Subjects in 40 CFR Part 180

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

Dated: May 15, 2023.

Charles Smith,

Director, Registration Division, Office of Pesticide Programs.

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 § 180.910, amend table 1 to the section by adding, in alphabetical order, the inert ingredient “Benzyl alcohol (CAS Reg. No. 100–51–6)” to read as follows:

§ 180.910

Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.

* * * * *

Table 1 to 180.910

Inert ingredients	Limits	Uses
*         *         *         *         *         *         *
Benzyl alcohol (CAS Reg. No. 100–51–6)	60% by weight in pesticide formulation	Adjuvant.
*         *         *         *         *         *         *