[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Rules and Regulations]
[Pages 32133-32138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10709]



[[Page 32133]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0173; FRL-10940-01-OCSPP]


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: 
[email protected].

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):

[[Page 32134]]

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

[[Page 32135]]

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
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      NOAEL = 400 mg/kg/day    Acute RfD = 4.00 mg/kg/  13-week oral toxicity--
 including infants and children).      UFA = 10x..............   day.                     Rat LOAEL = 800 mg/kg/
                                       UFH = 10x..............  aPAD = 4.0 mg/kg/day...   day based on clinical
                                       FQPA SF = 1x...........                            signs of neurotoxicity
                                                                                          after a single dose.
Chronic dietary (All populations)....  NOAEL= 250 mg/kg/day     Chronic RfD = 2.0 mg/kg/ 16-day oral toxicity--
                                       UFA = 10x..............   day.                     Mouse LOAEL = 500 mg/
                                       UFH = 10x..............  cPAD = 2.0 mg/kg/day...   kg/day based on
                                       FQPA SF = 1x...........                            lethargy.
Incidental oral short- and             NOAEL= 250 mg/kg/day     LOC for MOE = 100......  16-day oral toxicity--
 intermediate-term (1 to 30 days and   UFA = 10x..............                            Mouse LOAEL = 500 mg/
 1 to 6 months).                       UFH = 10x..............                            kg/day based on
                                       FQPA SF = 1x...........                            lethargy.
Dermal short- and intermediate-term    NOAEL = 250 mg/kg/day    LOC for MOE = 100......  16-day oral toxicity--
 (1 to 30 days and 1 to 6 months).      (dermal absorption                                Mouse LOAEL = 500 mg/
                                        rate = 100%)                                      kg/day based on
                                       UFA = 10x..............                            lethargy.
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
Inhalation short- and intermediate-    Inhalation study NOAEL=  LOC for MOE = 100......  4-week inhalation
 term (1 to 30 days and 1 to 6          1,072 mg/m\3\ (~328 mg/                           toxicity study--Rat
 months).                               kg/day) (inhalation                              LOAEL was not
                                        absorption rate =                                 established.
                                        100%)
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
                                      --------------------------------------------------------------------------
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.
  UFA = extrapolation from animal to human (interspecies). UFH = 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

[[Page 32136]]

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/

[[Page 32137]]

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

[[Page 32138]]

``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

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  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:


Sec.  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.     60% by weight in   Adjuvant.
 100-51-6).                       pesticide
                                  formulation.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2023-10709 Filed 5-18-23; 8:45 am]
BILLING CODE 6560-50-P


