[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Rules and Regulations]
[Pages 43420-43427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15017]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0296; FRL-9924-01-OCSPP]


Various Fragrance Components; Exemptions From the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of various fragrance components listed in unit 
II of this document when they are used as inert ingredients in 
antimicrobial pesticide formulations for use on food contact surfaces 
in public eating places, dairy processing equipment, and food 
processing equipment and utensils with end-use concentration not to 
exceed 100 parts per million (ppm). Verto Solutions on behalf of The 
Clorox Company submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting the establishment of such 
exemptions from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of various fragrance components.

DATES: This regulation is effective July 21, 2022. Objections and 
requests for hearings must be received on or before September 19, 2022, 
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-2020-0296, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), 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#6b392f2d3925041f02080e182b0e1b0a450c041d"><span class="__cf_email__" data-cfemail="e7b5a3a1b5a988938e848294a7829786c9808891">[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> 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 
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, 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-2020-0296 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 
September 19, 2022. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2020-0296, by one of 
the following methods:
    <bullet> 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.
    <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 https://www.epa.gov/dockets/contacts.html.
    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 June 24, 2020 (85 FR 37807) (FRL-10010-
82), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11018) by 
Verto Solutions on behalf of The Clorox Company, 4900 Johnson Dr., 
Pleasanton, CA 94588. The petition requested that 40 CFR 180.940(a) be 
amended by

[[Page 43421]]

establishing an exemption from the requirement of a tolerance for 
residues of acetaldehyde ethyl cis- 3-hexenyl acetal (CAS Reg. No. 
28069-74-1), (tri-)acetin (CAS Reg. No. 102-76-1), acetophenone (CAS 
Reg. No. 98-86-2), allyl alpha-ionone (CAS Reg. No. 79-78-7), 
benzaldehyde (CAS Reg. No. 100-52-7), benzyl alcohol (CAS Reg. No. 100-
51-6), benzyl butyrate (CAS Reg. No. 103-37-7), benzyl isobutyrate (CAS 
Reg. No. 103-28-6), benzyl propionate (CAS Reg. No. 122-63-4), 
carvacrol (CAS Reg. No. 499-75-2), cinnamaldehyde (CAS Reg. No. 104-55-
2), cinnamyl alcohol (CAS Reg. No. 104-54-1), cuminaldehyde (CAS Reg. 
No. 122-03-2), diethyl malonate (CAS Reg. No. 105-53-3), 1,1-diethoxy-
3,7- dimethylocta-2,6-diene (CAS Reg. No. 7492-66-2), dihydro-beta-
ionone (CAS Reg. No. 17283-81-7), dihydrocarvyl acetate (CAS Reg. No. 
20777-49-5), ethyl acetoacetate (CAS Reg. No. 141-97-9), ethyl benzoate 
(CAS Reg. No. 93-89-0), ethylene brassylate (CAS Reg. No. 105-95-3), 
ethyl salicylate (CAS Reg. No. 118-61-6), 4-formy-l-2- methoxyphenyl 2- 
methylpropanoate; vanillin isobutyrate (CAS Reg. No. 20665-85-4), 
hydroxycitronellal (CAS Reg. No. 107-75-5), hydroxycitronellol (CAS 
Reg. No. 107-74-4), 4-(p-hydroxyphenyl)-2- butanone (CAS Reg. No. 5471-
51-2), p-methoxybenzaldehyde (CAS Reg. No. 123-11-5), 2-methoxy-4- 
propylphenol (CAS Reg. No. 2785-87-7), 4'-methylacetophenone (CAS Reg. 
No. 122-00-9), alpha-methylbenzyl acetate (CAS Reg. No. 93-92-5), 
alpha-methylbenzyl alcohol (CAS Reg. No. 98-85-1), methyl benzoate (CAS 
Reg. No. 93-58-3), alpha- methylcinnamaldehyde (CAS Reg. No. 101-39-3), 
methyl cinnamate (CAS Reg. No. 103-26-4), 5-methyl-2-hepten-4- one (CAS 
Reg. No. 81925-81-7), alpha-iso-methylionone (CAS Reg. No. 127-51-5), 
methyl salicylate (CAS Reg. No. 119-36-8), cis-6-nonenal (CAS Reg. No. 
2277-19-2), cis-6-nonen-1-ol (CAS Reg. No. 35854-86-5), octanal 
dimethyl acetal (CAS Reg. No. 10022-28-3), phenethyl acetate (CAS Reg. 
No. 103-45-7), phenethyl alcohol (CAS Reg. No. 60-12-8), phenethyl 
isobutyrate (CAS Reg. No. 103-48-0), phenethyl phenylacetate (CAS Reg. 
No. 102-20-5), phenylacetaldehyde dimethyl acetal (CAS Reg. No. 101-48-
4), 3-phenyl-1-propanol (CAS Reg. No. 122-97-4), 1-(2,6,6-
trimethylcyclohexa-1,3- dienyl)-2-buten-1-one (CAS Reg. No. 23696-85-
7), delta-1-(2,6,6-trimethyl- 3-cyclohexen-1-yl)-2- buten-1-one (CAS 
Reg. No. 57378-68-4), triethyl citrate (CAS Reg. No. 77-93-0), 
thiogeraniol (CAS Reg. No. 39067-80-6), thymol (CAS Reg. No. 89-83-8), 
vanillin (CAS Reg. No. 121-33-5), veratraldehyde (CAS Reg. No. 120-14-
9) when used as an inert ingredient fragrance component in pesticide 
formulations applied to food contact surfaces in public eating places, 
dairy processing equipment, and food processing equipment with end-use 
concentrations not to exceed 100 ppm. That document referenced a 
summary of the petition prepared by Verto Solutions on behalf of The 
Clorox Company, the petitioner, which is available in the docket, 
https://www.regulations.gov/docket/EPA-HQ-OPP-2020-0296. 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(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no harm to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for various fragrance components 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with various 
fragrance components 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 for the various 
fragrance components are discussed in this unit.
    The Agency assessed these fragrance components via the Threshold of 
Toxicological Concern (TTC) approach as outlined by the European Food 
Safety Authority (EFSA) in their 2019 guidance document on the use of 
TTC in food safety assessment. Information regarding the database of 
studies and chemicals used to derive TTCs are reviewed therein. The TTC 
approach has been used by the Joint Expert Committee on

[[Page 43422]]

Food Additives of the U.N.'s Food and Agriculture Organization and the 
World Health Organization, the former Scientific Committee on Food of 
the European Commission, the European Medicines Agency, and EFSA.
    Information from JECFA reports as well as predictive toxicology 
using the OECD QSAR Toolbox was used to confirm that the fragrances 
listed in Unit II have low carcinogenic potential and are thus good 
candidates for the application of the TTC method. Although 13 chemicals 
had carcinogenicity alerts, JECFA concluded and EPA concurs that all 
fragrances listed in unit II have low carcinogenic potential, based on 
in vitro and/or in vivo genotoxicity studies available. Therefore, the 
TTC method can be applied to these fragrances.
    TTCs are derived from a conservative and rigorous approach 
developed by Munro and Kroes to establish generic threshold values for 
human exposure at which a very low probability of adverse effects is 
likely. By comparing a range of compounds by Cramer Class (classes I, 
II, and III) and NOEL (no-observed-effect-level), fifth percentile 
NOELs were established for each Cramer Class as ``Human Exposure 
Thresholds''. These values were 3, 0.91 and 0.15 mg/kg/day for classes 
I, II, and III, respectively.

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.
    The human exposure threshold value for threshold (i.e., non-cancer) 
risks is based upon Cramer structural class. In the case of the 
fragrance components listed above, all the substances included are in 
the Cramer Class I category, which is defined as chemicals of simple 
structure and efficient modes of metabolism, suggesting low oral 
toxicity.
    Therefore, the NOEL of 3 mg/kg/day is selected as the point of 
departure for all exposure scenarios assessed (chronic dietary, 
incidental oral, dermal and inhalation exposures).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Dietary exposure (food 
and drinking water) may occur from the existing (non-food) and proposed 
uses of fragrance components listed in unit II (e.g., eating foods 
treated with pesticide formulations containing these fragrances, and 
drinking water exposures). In evaluating dietary exposure to each of 
the fragrance components listed in Unit II, EPA considered exposure 
under the proposed tolerance exemptions at a concentration not to 
exceed 100 ppm for each of the fragrance components listed in Unit II. 
as well as any other sources of dietary exposure. EPA assessed dietary 
exposures from various fragrance components in food as follows:
    The dietary assessment for food contact sanitizer solutions 
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake 
(EDI). The assessment considered: Application rates, residual solution 
or quantity of solution remaining on the treated surface without 
rinsing with potable water, surface area of the treated surface which 
comes into contact with food, pesticide migration fraction, and body 
weight. These assumptions are based on Food and Drug Administration 
(FDA) guidelines.
    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 various fragrance 
components 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. Residential exposure. The term ``residential exposure'' is used 
in this document to refer to non-occupational, non-dietary exposure 
(e.g., textiles (clothing and diapers), carpets, swimming pools, and 
hard surface disinfection on walls, floors, tables). The fragrance 
components listed in Unit II may be used as inert ingredients in 
products that are registered for specific uses that may result in 
residential exposure, such as pesticides used in and around the home. 
The Agency conducted a conservative assessment of potential residential 
exposure by assessing various fragrance components in disinfectant-type 
uses (indoor scenarios). The Agency's assessment of adult residential 
exposure combines high-end dermal and inhalation handler exposure from 
indoor hard surface, wiping and aerosol spray. The Agency's assessment 
of children's residential exposure includes total post-application 
exposures associated with total exposures associated with contact with 
treated indoor surfaces (dermal and hand-to-mouth exposures).
    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 made a common mechanism of toxicity finding as to these 
fragrance chemicals listed in unit II and any other substances, and 
these fragrance chemicals do not appear to produce toxic metabolites 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that these fragrance chemicals 
listed in unit II 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/pesticides/cumulative.

D. Safety Factor for Infants and Children

    FFDCA Section 408(b)(2)(C) provides that EPA shall retain 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

[[Page 43423]]

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 FQPA safety factor (SF). 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 FQPA SF 
has been reduced to 1X in this risk assessment because clear NOELs and 
LOELs were established in the studies analyzed by Munro et al 1996 
(which included developmental and reproductive toxicity studies), 
maternal and developmental-specific 5th percentile NOAELs calculated by 
van Ravenzwaay et al 2011 indicate low potential for offspring 
susceptibility, and the conservative assumptions made in the exposure 
assessment are unlikely to underestimate risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute aggregate risk. An acute aggregate risk assessment takes 
into account acute exposure estimates from dietary consumption of food 
and drinking water. No adverse effects resulting from a single oral 
exposure were identified and no acute dietary endpoint were selected 
for any of the fragrance components. Therefore, the fragrance 
components listed in Unit II are not expected to pose an acute risk.
    2. Short-term aggregate 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). For 
residential handler short-term exposure scenarios, MOEs ranged from 140 
to 2,500, while residential post-application exposure scenarios MOEs 
ranged from 380 to 7,400. These MOEs are greater than the LOC of 100 
and therefore are not of concern. The short-term aggregate MOE is 109 
for adults and 135 for children, which are greater than the LOC of 100 
and therefore are not of concern.
    3. 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). An intermediate-term adverse effect was identified; however, 
the fragrance components listed in Unit II are not currently used as an 
inert ingredient in pesticide products that are registered for any use 
patterns that would result in intermediate-term residential exposure. 
Intermediate-term risk is assessed based on intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for various fragrance components.
    4. Chronic aggregate risk. Using the exposure assumptions described 
in this unit for chronic exposure, EPA has concluded that chronic 
exposure to the fragrance components listed in Unit II from food and 
water will utilize 19% of the chronic PAD (cPAD) for the U.S. 
population and 48% of the cPAD for children 1 to 2 years old, the 
population group receiving the greatest exposure. Chronic residential 
exposure to residues of benoxacor is not expected. Therefore, the 
chronic aggregate risk is equal to the chronic dietary exposure for 
children 1 to 2 years old (48% of the PAD).
    5. Aggregate cancer risk for U.S. population. There is low concern 
for genotoxicity/carcinogenicity in humans for the fragrance components 
listed in Unit II of this document. Therefore, the assessment under the 
TTC value for non-cancer risks is protective for all risks, including 
carcinogenicity.
    6. Determination of safety. Based on these risk assessments, 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 residues of the fragrance components listed in Unit II.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for fragrances 
listed in unit II of this document in or on any food commodities. EPA 
is establishing a limitation on the amount of the fragrances listed in 
unit II that may be used in antimicrobial pesticide formulations. This 
limitations 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 100ppm of fragrances listed in 
unit II in the final pesticide formulation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for the fragrance components 
listed in Unit II.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for acetaldehyde ethyl cis- 3-
hexenyl acetal (CAS Reg. No. 28069-74-1), (tri-)acetin (CAS Reg. No. 
102-76-1), acetophenone (CAS Reg. No. 98-86-2), allyl alpha-ionone (CAS 
Reg. No. 79-78-7), benzaldehyde (CAS Reg. No. 100-52-7), benzyl alcohol 
(CAS Reg. No. 100-51-6), benzyl butyrate (CAS Reg. No. 103-37-7), 
benzyl isobutyrate (CAS Reg. No. 103-28-6), benzyl propionate (CAS Reg. 
No. 122-63-4), carvacrol (CAS Reg. No. 499-75-2), cinnamic aldehyde 
(cinnamaldehyde) (CAS Reg. No. 104-55-2), cinnamic alcohol (cinnamyl 
alcohol) (CAS Reg. No. 104-54-1), cuminaldehyde (CAS Reg. No. 122-03-
2), diethyl malonate (CAS Reg. No. 105-53-3), 1,1-diethoxy-3,7- 
dimethylocta-2,6-diene (CAS Reg. No. 7492-66-2), dihydro-beta-ionone 
(CAS Reg. No. 17283-81-7), dihydrocarvyl acetate (CAS Reg. No. 20777-
49-5), butanoic acid, 3-oxo-, ethyl ester (ethyl acetoacetate) (CAS 
Reg. No. 141-97-9),

[[Page 43424]]

benzoic acid, ethyl ester (ethyl benzoate) (CAS Reg. No. 93-89-0), 
ethylene brassylate (CAS Reg. No. 105-95-3), ethyl salicylate (CAS Reg. 
No. 118-61-6), propanoic acid, 2-methyl-, 4-formyl-2-methoxyphenyl 
ester (4-formy-l-2- methoxyphenyl 2- methylpropanoate; vanillin 
isobutyrate) (CAS Reg. No. 20665-85-4), hydroxycitronellal (CAS Reg. 
No. 107-75-5), hydroxycitronellol (CAS Reg. No. 107-74-4), 4-(p-
hydroxyphenyl)-2- butanone (CAS Reg. No. 5471-51-2), benzaldehyde, 4-
methoxy- (p-methoxybenzaldehyde) (CAS Reg. No. 123-11-5), 2-methoxy-4- 
propylphenol (CAS Reg. No. 2785-87-7), 4'-methylacetophenone (CAS Reg. 
No. 122-00-9), benzenemethanol, alpha-methyl-, 1-acetate (alpha-
methylbenzyl acetate) (CAS Reg. No. 93-92-5), alpha-methylbenzyl 
alcohol (CAS Reg. No. 98-85-1), methyl benzoate (CAS Reg. No. 93-58-3), 
alpha- methylcinnamaldehyde (CAS Reg. No. 101-39-3), methyl cinnamate 
(CAS Reg. No. 103-26-4), 2-hepten-4-one, 5-methyl- (5-methyl-2-hepten-
4- one) (CAS Reg. No. 81925-81-7), 3-buten-2-one, 3-methyl-4-(2,6,6-
trimethyl-2-cyclohexen-1-yl)- (alpha-iso-methylionone) (CAS Reg. No. 
127-51-5), methyl salicylate (CAS Reg. No. 119-36-8), 6-nonenal, (6Z)- 
(cis-6-nonenal) (CAS Reg. No. 2277-19-2), cis-6-nonen-1-ol (CAS Reg. 
No. 35854-86-5), octanal dimethyl acetal (CAS Reg. No. 10022-28-3), 
phenethyl acetate (CAS Reg. No. 103-45-7), phenyl ethyl alcohol 
(phenethyl alcohol) (CAS Reg. No. 60-12-8), phenethyl isobutyrate (CAS 
Reg. No. 103-48-0), phenethyl phenylacetate (CAS Reg. No. 102-20-5), 
phenylacetaldehyde dimethyl acetal (CAS Reg. No. 101-48-4), 3-phenyl-1-
propanol (CAS Reg. No. 122-97-4), 2-buten-1-one, 1-(2,6,6-trimethyl-
1,3-cyclohexadien-1-yl)- (1-(2,6,6-trimethylcyclohexa-1,3- dienyl)-2-
buten-1-one (CAS Reg. No. 23696-85-7), delta-1-(2,6,6-trimethyl- 3-
cyclohexen-1-yl)-2- buten-1-one (CAS Reg. No. 57378-68-4), triethyl 
citrate (CAS Reg. No. 77-93-0), thiogeraniol (CAS Reg. No. 39067-80-6), 
thymol (8CA) (thymol) (CAS Reg. No. 89-83-8), vanillin (CAS Reg. No. 
121-33-5), veratraldehyde (CAS Reg. No. 120-14-9) when used as an inert 
ingredient (fragrance components) in pesticide formulations applied to 
food contact surfaces in public eating places, dairy processing 
equipment, and food processing equipment and utensils with end-use 
concentration not to exceed 100 ppm.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, 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 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: July 8, 2022.
Marietta Echeverria,
Acting 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 CHEMICALS 
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. Section 180.940 is amended by adding in alphabetical order the 
following inert ingredients to table 1 to paragraph (a):
0
a. acetaldehyde ethyl cis-3-hexenyl acetal
0
b. Acetophenone
0
c. allyl alpha-ionone
0
d. Benzaldehyde
0
e. benzyl alcohol
0
f. benzyl butyrate
0
g. benzyl isobutyrate
0
h. benzaldehyde, 4-methoxy-
0
i. benzenemethanol, alpha-methyl-, 1-acetate
0
j. benzoic acid, ethyl ester
0
k. butanoic acid, 3-oxo-, ethyl ester
0
l. 2-buten-1-one, 1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-
0
m. 3-buten-2-one, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-
0
n. Carvacrol
0
o. cinnamic aldehyde

[[Page 43425]]

0
p. cinnamic alcohol
0
q. Cuminaldehyde
0
r. diethyl malonate
0
s. 1,1-diethoxy-3,7-dimethylocta-2,6-diene
0
t. dihydro-beta-ionone
0
u. dihydrocarvyl acetate
0
v. ethylene brassylate
0
w. ethyl salicylate
0
x. glyceryl triacetate
0
y. 2-hepten-4-one, 5-methyl-
0
z. Hydroxycitronellal
0
aa. Hydroxycitronellol
0
bb. 4-(p-hydroxyphenyl)-2-butanone
0
cc. 2-methoxy-4-propylphenol
0
dd. methyl benzoate
0
ee. 4'-methylacetophenone
0
ff. alpha-methylbenzyl alcohol
0
gg. alpha-methylcinnamaldehyde
0
hh. methyl cinnamate
0
ii. methyl salicylate
0
jj. 6-nonenal, (6Z)-
0
kk. cis-6-nonen-1-ol
0
ll. octanal dimethyl acetal
0
mm. phenethyl acetate
0
nn. phenyl ethyl alcohol
0
oo. phenethyl isobutyrate
0
pp. phenethyl phenylacetate
0
qq. phenylacetaldehyde dimethyl acetal
0
rr. 3-phenyl-1-propanol
0
ss. propanoic acid, 2-methyl-, 4-formyl-2-methoxyphenyl ester
0
tt. triethyl citrate
0
uu. delta-1-(2,6,6-trimethyl-3-cyclohexen-1-yl)-2-buten-1-
0
vv. Thiogeraniol
0
ww. thymol (8CA)
0
xx. Vanillin
0
yy. veratraldehyde
    The additions read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------
 
                              * * * * * * *
acetaldehyde ethyl cis-3-            28069-74-1  When ready for use, the
 hexenyl acetal.                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Acetophenone...................         98-86-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
allyl alpha-ionone.............         79-78-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Benzaldehyde...................        100-52-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
benzyl alcohol.................        100-51-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
benzyl butyrate................        103-37-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
benzyl isobutyrate.............        103-28-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
benzyl propionate..............        122-63-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
benzaldehyde, 4-methoxy-.......        123-11-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
benzenemethanol, alpha-methyl-,         93-92-5  When ready for use, the
 1-acetate.                                       end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
benzoic acid, ethyl ester......         93-89-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
butanoic acid, 3-oxo-, ethyl           141-97-9  When ready for use, the
 ester.                                           end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2-buten-1-one, 1-(2,6,6-             23696-85-7  When ready for use, the
 trimethyl-1,3-cyclohexadien-1-                   end-use concentration
 yl)-.                                            is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
3-buten-2-one, 3-methyl-4-             127-51-5  When ready for use, the
 (2,6,6-trimethyl-2-cyclohexen-                   end-use concentration
 1-yl)-.                                          is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Carvacrol......................        499-75-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
cinnamic aldehyde..............        104-55-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
cinnamic alcohol...............        104-54-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

[[Page 43426]]

 
 
                              * * * * * * *
Cuminaldehyde..................        122-03-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
diethyl malonate...............        105-53-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
1,1-diethoxy-3,7-dimethylocta-        7492-66-2  When ready for use, the
 2,6-diene.                                       end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
dihydro-beta-ionone............      17283-81-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
dihydrocarvyl acetate..........      20777-49-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
ethylene brassylate............        105-95-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
ethyl salicylate...............        118-61-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
glyceryl triacetate............        102-76-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2-hepten-4-one, 5-methyl-......      81925-81-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Hydroxycitronellal.............        107-75-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Hydroxycitronellol.............        107-74-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
4-(p-hydroxyphenyl)-2-butanone.       5471-51-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2-methoxy-4-propylphenol.......       2785-87-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
methyl benzoate................         93-58-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
4'-methylacetophenone..........        122-00-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
alpha-methylbenzyl alcohol.....         98-85-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
alpha-methylcinnamaldehyde.....        101-39-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
methyl cinnamate...............        103-26-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
methyl salicylate..............        119-36-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
6-nonenal, (6Z)-...............       2277-19-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
cis-6-nonen-1-ol...............      35854-86-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
octanal dimethyl acetal........      10022-28-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
phenethyl acetate..............        103-45-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
phenyl ethyl alcohol...........         60-12-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

[[Page 43427]]

 
 
                              * * * * * * *
phenethyl isobutyrate..........        103-48-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
phenethyl phenylacetate........        102-20-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
phenylacetaldehyde dimethyl            101-48-4  When ready for use, the
 acetal.                                          end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
3-phenyl-1-propanol............        122-97-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
propanoic acid, 2-methyl-, 4-        20665-85-4  When ready for use, the
 formyl-2-methoxyphenyl ester.                    end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
triethyl citrate...............         77-93-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
delta-1-(2,6,6-trimethyl-3-          57378-68-4  When ready for use, the
 cyclohexen-1-yl)-2-buten-1-one.                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Thiogeraniol...................      39067-80-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
thymol (8CA)...................         89-83-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Vanillin.......................        121-33-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
veratraldehyde.................        120-14-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. 2022-15017 Filed 7-20-22; 8:45 am]
BILLING CODE 6560-50-P


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