Rule2023-10709
Benzyl Alcohol; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 19, 2023
Effective
May 19, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 97 (Friday, May 19, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10709]
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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.
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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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#aefceae8fce0c1dac7cdcbddeecbdecf80c9c1d8"><span class="__cf_email__" data-cfemail="3c6e787a6e725348555f594f7c594c5d125b534a">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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 <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
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
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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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...........
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
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
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</html>Indexed from Federal Register on May 19, 2023.
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