Document ID: EPA-HQ-OPP-2020-0294-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Various Fragrance Components
Posted Date: 2021-12-22T05:00Z

[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Rules and Regulations]
[Pages 72525-72531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27580]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0294; FRL-9226-01-OCSPP]

Various Fragrance Components; Exemptions From the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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 December 22, 2021. Objections and 
requests for hearings must be received on or before February 22, 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-2020-0294, 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and 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: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2020-0294 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 
February 22, 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-2020-0294, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/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-11016) 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 72526]]

establishing an exemption from the requirement of a tolerance for 
residues of [delta]-decalactone (CAS Reg. No. 705-86-2), [gamma]-
decalactone (CAS Reg. No. 706-14-9), dimethyl-1-octanol (CAS Reg. No. 
106-21-8), 3,7, ethyl acetate (CAS Reg. No. 141-78-6), ethyl butyrate 
(CAS Reg. No. 105-54-4), ethyl decanoate (CAS Reg. No. 110-38-3); ethyl 
heptanoate (CAS Reg. No. 106-30-9), ethyl hexanoate (CAS Reg. No. 123-
66-0), ethyl isobutyrate (CAS Reg. No. 97-62-1), ethyl laurate (CAS 
Reg. No. 106-33-2), ethyl octanoate (CAS Reg. No. 106-32-1), ethyl 
nonanoate (CAS Reg. No. 123-29-5), [gamma]-heptalactone (CAS Reg. No. 
105-21-5), [gamma]-hexalactone (CAS Reg. No. 695-06-7), cis-3-hexenyl 
butyrate (CAS Reg. No. 16491-36-4), cis-3-hexenyl hexanoate (CAS Reg. 
No. 31501-11-8), 3-hexenyl 2-methylbutanoate (CAS Reg. No. 10094-41-4), 
hexyl butyrate (CAS Reg. No. 2639-63-6), hexyl hexanoate (CAS Reg. No. 
6378-65-0), hexyl isobutyrate (CAS Reg. No. 2349-07-7), hexyl 
propionate (CAS Reg. No. 2445-76-3), hydroxynonanoic acid, [delta]-
lactone (CAS Reg. No. 3301-94-8), 5-hydroxyundecanoic acid lactone (CAS 
Reg. No. 710-04-3), isoamyl acetate (CAS Reg. No. 123-92-2), isoamyl 
alcohol (CAS Reg. No. 123-51-3), isoamyl butyrate (CAS Reg. No. 106-27-
4), isobutyl acetate (CAS Reg. No. 110-19-0), isobutyl isobutyrate (CAS 
Reg. No. 97-85-8), isopropyl 2-methylbutyrate (CAS Reg. No. 66576-71-
4), Lavandin oil (Lavandula hybrida) (CAS Reg. No. 8022-15-9), linalool 
(CAS Reg. No. 78-70-6), linalyl acetate (CAS Reg. No.115-95-7), 
[gamma]-nonalactone (CAS Reg. No. 104-61-0), [gamma]-octalactone (CAS 
Reg. No. 104-50-7), [omega]-pentadecalactone (CAS Reg. No. 106-02-5), 
Petitgrain bigarade oil (CAS Reg. No. 8014-17-3), [alpha]-terpineol 
(CAS Reg. No. 98-55-5), terpinyl acetate (isomer mixture) (CAS Reg. No. 
8007-35-0), Tetrahydrolinalool (CAS Reg. No. 78-69-3), [gamma]-
undecalactone (CAS Reg. No. 104-67-6), 10-undecen-1-yl acetate (CAS 
Reg. No. 112-19-6) 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. 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 appreciable risks 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 and the nature 
of the adverse effects caused by various fragrance components as well 
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are 
discussed in this unit.
    The Agency assessed these fragrance components via the Threshold of 
toxicological concern (TTC) approach as outlined by the European Food 
Safety Authority (EFSA) in their 2018 proposed guidance document on the 
use of TTC in food safety assessment. This approach relies on the most 
recent evaluation of the literature on TTC as reviewed by EFSA and the 
World Health Organization (WHO) in 2016. 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 Food Additives of the United Nation'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.
    Thresholds of toxicological concern (TTC) are derived from a 
conservative and rigorous approach developed by

[[Page 72527]]

Munro and Kroes (Munro et al. 1996) 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 their structure 
using the Cramer classification scheme, i.e., Cramer Class (Cramer et 
al. 1978), and NOEL (no-observed-effect-level), fifth percentile NOELs 
were established for each Cramer Class as ``Human Exposure Thresholds'' 
assuming a 60 kg human. These determined values were 30, 9, and 1.5 
[mu]g/kg/day for Cramer Class 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/pesticides/factsheets/riskassess.htm.
    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. The corresponding TTC value for substances in the Cramer 
Class I category is 30 [mu]g/kg/day, which is based on a 5th percentile 
NOEL of 3 mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. 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.
    The dietary assessment for food contact sanitizer solutions showed 
that children 1 to 2 years old would be the highest exposed subgroup 
(48% of the chronic PAD (cPAD)). The general U.S. population resulted 
in 19% of the cPAD. Any percent cPAD exceeding 100% would be of 
concern.
    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. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Various fragrance components 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 pesticide 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 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
(FQPA) safety factor (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

[[Page 72528]]

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 underestimate risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse 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. Chronic 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 48% 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).
    The fragrance components listed in Unit II are currently 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 the 
fragrance components listed in Unit II.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 109 for both 
adult males and females. EPA has concluded the combined short-term 
aggregated food, water, and residential pesticide exposures result in 
an aggregate MOE of 135 for children. Because EPA's level of concern 
for the fragrance components listed in Unit II of this document is an 
MOE of 100 or below, 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). 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.
    5. Aggregate cancer risk for U.S. population. No structural alerts 
for cancer that are relevant to humans were identified for the 
fragrance components listed in Unit II Therefore, there is low concern 
for genotoxicity/carcinogenicity in humans and 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 residues of 
the fragrances listed in unit II 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 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 100 ppm of any one of the 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 [delta]-decalactone (CAS Reg. 
No. 705-86-2), [gamma]-decalactone (CAS Reg. No. 706-14-9), dimethyl-1-
octanol (CAS Reg. No. 106-21-8), 3,7, ethyl acetate (CAS Reg. No. 141-
78-6), ethyl butyrate (CAS Reg. No. 105-54-4), ethyl decanoate (CAS 
Reg. No. 110-38-3); ethyl heptanoate (CAS Reg. No. 106-30-9), ethyl 
hexanoate (CAS Reg. No. 123-66-0), ethyl isobutyrate (CAS Reg. No. 97-
62-1), ethyl laurate (CAS Reg. No. 106-33-2), ethyl octanoate (CAS Reg. 
No. 106-32-1), ethyl nonanoate (CAS Reg. No. 123-29-5), [gamma]-
heptalactone (CAS Reg. No. 105-21-5), [gamma]-hexalactone (CAS Reg. No. 
695-06-7), cis-3-hexenyl butyrate (CAS Reg. No. 16491-36-4), cis-3-
hexenyl hexanoate (CAS Reg. No. 31501-11-8), 3-hexenyl 2-
methylbutanoate (CAS Reg. No. 10094-41-4), hexyl butyrate (CAS Reg. No. 
2639-63-6), hexyl hexanoate (CAS Reg. No. 6378-65-0), hexyl isobutyrate 
(CAS Reg. No. 2349-07-7), hexyl propionate (CAS Reg. No. 2445-76-3), 
hydroxynonanoic acid, [delta]-lactone (CAS Reg. No. 3301-94-8), 5-
hydroxyundecanoic acid lactone (CAS Reg. No. 710-04-3), isoamyl acetate 
(CAS Reg. No. 123-92-2), isoamyl alcohol (CAS Reg. No. 123-51-3), 
isoamyl butyrate (CAS Reg. No. 106-27-

[[Page 72529]]

4), isobutyl acetate (CAS Reg. No. 110-19-0), isobutyl isobutyrate (CAS 
Reg. No. 97-85-8), isopropyl 2-methylbutyrate (CAS Reg. No. 66576-71-
4), Lavandin oil (Lavandula hybrida) (CAS Reg. No. 8022-15-9), linalool 
(CAS Reg. No. 78-70-6), linalyl acetate (CAS Reg. No.115-95-7), 
[gamma]-nonalactone (CAS Reg. No. 104-61-0), [gamma]-octalactone (CAS 
Reg. No. 104-50-7), [omega]-pentadecalactone (CAS Reg. No. 106-02-5), 
Petitgrain bigarade oil (CAS Reg. No. 8014-17-3), [alpha]-terpineol 
(CAS Reg. No. 98-55-5), terpinyl acetate (isomer mixture) (CAS Reg. No. 
8007-35-0), Tetrahydrolinalool (CAS Reg. No. 78-69-3), [gamma]-
undecalactone (CAS Reg. No. 104-67-6), 10-undecen-1-yl acetate (CAS 
Reg. No. 112-19-6) 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: December 10, 2021.
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 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.  180.940, amend the table in paragraph (a) by revising the 
heading and adding in alphabetical order the inert ingredients 
``[delta]-decalactone'', ``[gamma]-decalactone'', ``dimethyl-1-
octanol'', ``3,7, ethyl acetate'', ``ethyl butyrate'', ``ethyl 
decanoate''; ``ethyl heptanoate'', ``ethyl hexanoate'', ``ethyl 
isobutyrate'', ``ethyl laurate'', ``ethyl octanoate'', ``ethyl 
nonanoate'', ``[gamma]-heptalactone'', ``[gamma]-hexalactone'', ``cis-
3-hexenyl butyrate'', ``cis-3-hexenyl hexanoate'', ``3-hexenyl 2-
methylbutanoate'', ``hexyl butyrate'', ``hexyl hexanoate'', ``hexyl 
isobutyrate'', ``hexyl propionate'', ``hydroxynonanoic acid, [delta]-
lactone'', ``5-hydroxyundecanoic acid lactone'', ``isoamyl acetate'', 
``isoamyl alcohol'', ``isoamyl butyrate'', ``isobutyl acetate'', 
``isobutyl isobutyrate'', ``isopropyl 2-methylbutyrate'', ``Lavandin 
oil (Lavandula hybrida)'', ``linalool'', ``linalyl acetate'', 
``[gamma]-nonalactone'', ``[gamma]-octalactone'', ``[omega]-
pentadecalactone'', ``Petitgrain bigarade oil'', ``[alpha]-terpineol'', 
``terpinyl acetate (isomer mixture)'', ``Tetrahydrolinalool'', 
``[gamma]-undecalactone'', and ``10-undecen-1-yl acetate'' to 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
------------------------------------------------------------------------
 
                              * * * * * * *
[delta]-decalactone..........        705-86-2  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
[gamma]-decalactone..........        706-14-9  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 

[[Page 72530]]

 
                              * * * * * * *
3,7-dimethyl-1-octanol.......        106-21-8  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
ethyl acetate................        141-78-6  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
ethyl butyrate...............        105-54-4  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
ethyl decanoate..............        110-38-3  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
ethyl heptanoate.............        106-30-9  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
ethyl hexanoate..............        123-66-0  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
ethyl isobutyrate............         97-62-1  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
ethyl laurate................        106-33-2  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
ethyl nonanoate..............        123-29-5  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
ethyl octanoate..............        106-32-1  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
[gamma]-heptalactone.........        105-21-5  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
[gamma]-hexalactone..........        695-06-7  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
cis-3-hexenyl butyrate.......      16491-36-4  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
cis-3-hexenyl hexanoate......      31501-11-8  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
3-hexenyl 2-methylbutanoate..      10094-41-4  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
hexyl butyrate...............       2639-63-6  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
hexyl hexanoate..............       6378-65-0  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
hexyl isobutyrate............       2349-07-7  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
hexyl propionate.............       2445-76-3  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
hydroxynonanoic acid, [delta]-      3301-94-8  When ready for use, the
 lactone.                                       end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
5-hydroxyundecanoic acid             710-04-3  When ready for use, the
 lactone.                                       end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
isoamyl acetate..............        123-92-2  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
isoamyl alcohol..............        123-51-3  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
isoamyl butyrate.............        106-27-4  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
isobutyl acetate.............        110-19-0  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
isobutyl isobutyrate.........         97-85-8  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
isopropyl 2-methylbutyrate...      66576-71-4  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
Lavandin oil (Lavandula             8022-15-9  When ready for use, the
 hybrida).                                      end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
linalool.....................         78-70-6  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
linalyl acetate..............        115-95-7  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
[gamma]-nonalactone..........        104-61-0  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
[gamma]-octalactone..........        104-50-7  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
[omega]-pentadecalactone.....        106-02-5  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
Petitgrain bigarade oil......       8014-17-3  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
[alpha]-terpineol............         98-55-5  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
terpinyl acetate (isomer            8007-35-0  When ready for use, the
 mixture).                                      end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
tetrahydrolinalool...........         78-69-3  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
[gamma]-undecalactone........        104-67-6  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.

[[Page 72531]]

 
 
                              * * * * * * *
10-undecen-1-yl acetate......        112-19-6  When ready for use, the
                                                end-use concentration is
                                                not to exceed 100 ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-27580 Filed 12-21-21; 8:45 am]
BILLING CODE 6560-50-P