Document ID: EPA-HQ-OPP-2019-0594-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Various Fragrance Components in Pesticide Formulations
Posted Date: 2023-05-19T04:00Z

[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Rules and Regulations]
[Pages 32125-32132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10550]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0594; FRL-10970-01-OCSPP]

Various Fragrance Components in Pesticide Formulations; Tolerance 
Exemption

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 applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils when the end-use concentration does 
not 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 
exemptions from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of these various fragrance components, when used in accordance 
with the terms of the exemptions.

DATES: This regulation is effective May 19, 2023. Objections and 
requests for hearings must be received on or before July 18, 2023 and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0594, 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: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection

[[Page 32126]]

Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main 
telephone number: (202) 566-1030; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0594 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
July 18, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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-2019-0594, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
    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 February 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11316) 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 establishing exemptions from the requirement 
of a tolerance for residues of 1,3,3-trimethyl-2-norbornanyl acetate 
(CAS Reg. No. 13851-11-1); 1H-Indole (CAS Reg. No. 120-72-9); 2,6-
Octadien-1-ol, 3,7-dimethyl-,(Z)- (CAS Reg. No. 106-25-2); 2-Decenal 
(CAS Reg. No. 3913-71-1); 2-Hexenal, (2E)- (CAS Reg. No. 6728-26-3); 2-
Methyl-3-(p-isopropylphenyl)propionaldehyde (CAS Reg. No. 103-95-7); 2-
Methyl-4-phenyl-2-butanol (CAS Reg. No. 103-05-9); 2-
Phenylpropionaldehyde (CAS Reg. No. 93-53-8); 2-Phenylpropionaldehyde 
dimethyl acetal (CAS Reg. No. 90-87-9); [alpha]-Pinene (CAS Reg. No. 
80-56-8); [beta]-Caryophyllene (CAS Reg. No. 87-44-5); 
Bicyclo(2.2.1)heptan-2-ol, 1,3,3-trimethyl- (CAS Reg. No. 1632-73-1); 
Bicyclo(2.2.1)heptan-2-ol, 1,7,7-trimethyl-,propanoate, exo- (CAS Reg. 
No. 2756-56-1); Bicyclo[3.1.1]heptane, 6,6-dimethyl-2-methylene- (CAS 
Reg. No. 127-91-3); Butanoic acid, 1,1-dimethyl-2-phenylethyl ester 
(CAS Reg. No. 10094-34-5); Celery seed oil (CAS Reg. No. 8015-90-5); 
Citronellal (CAS Reg. No. 106-23-0);Cyclohexene, 1-methyl-4-(1-
methylethylidene)- (CAS Reg. No. 586-62-9); Dimethylbenzylcarbinyl 
acetate (CAS Reg. No. 151-05-3); Elemi oil (Canarium spp.) (CAS Reg. 
No. 8023-89-0); Ethyl (2E,4Z)-2,4-decadienoate (CAS Reg. No. 3025-30-
7); Galbanum oil (Ferula spp.) (CAS Reg. No. 8023-91-4); [gamma] -
Terpinene (CAS Reg. No. 99-85-4); Isoborneol (CAS Reg. No. 124-76-5); 
Isobornyl acetate (CAS Reg. No. 125-12-2); Labdanum oil (Cistus spp.) 
(CAS Reg. No. 8016-26-0); laevo-Bornyl acetate (CAS Reg. No. 5655-61-
8); Mace oil (Myristica fragrans Houtt.) (CAS Reg. No. 8007-12-3); 
Methyl 2-nonenoate (CAS Reg. No. 111-79-5); Methyl 2-nonynoate (CAS 
Reg. No. 111-80-8); Methyl anthranilate (CAS Reg. No. 134-20-3); Methyl 
heptine carbonate (CAS Reg. No. 111-12-6); Methyl N-methylanthranilate 
(CAS Reg. No. 85-91-6); Nerolidol (isomer unspecified) (CAS Reg. No. 
7212-44-4); Nona-2-trans-6-cis-dienal (CAS Reg. No. 557-48-2); Oil of 
lemon (CAS Reg. No. 8008-56-8); Oil of lemongrass (CAS Reg. No. 8007-
02-1); Oils, clove (CAS Reg. No. 8000-34-8); Oils, ginger (CAS Reg. No. 
8007-08-7); Oils, grapefruit (CAS Reg. No. 8016-20-4); Oils, lime (CAS 
Reg. No. 8008-26-2); Oils, orange, sweet, terpene-free (CAS Reg. No. 
68606-94-0); Olibanum oil (Boswellia spp.) (CAS Reg. No. 8016-36-2); 
Oxacycloheptadec-10-ene-2-one (CAS Reg. No. 28645-51-4); p-Cymene (CAS 
Reg. No. 99-87-6); Phenol, 2-methoxy-4-(2-propenyl)- (CAS Reg. No. 97-
53-0); p-Methylanisole (CAS Reg. No. 104-93-8); Tangerine oil (Citrus 
reticulata blanco) (CAS Reg. No. 8008-31-9); Ylang-ylang oils (CAS Reg. 
No. 8006-81-3); when used as inert ingredients (fragrance components) 
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, 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;

[[Page 32127]]

and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. When making a safety determination for an 
exemption for the requirement of a tolerance, FFDCA section 
408(c)(2)(B) directs EPA to consider the considerations in section 
408(b)(2)(C) and (D). 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. . . .'' Section 408(b)(2)(D) lists other factors for EPA's 
consideration in making safety determinations, e.g., the validity, 
completeness, and reliability of available data, nature of toxic 
effects, available information concerning the cumulative effects of the 
pesticide chemical and other substances with a common mechanism of 
toxicity, and available information concerning aggregate exposure 
levels to the pesticide chemical and other related substances, among 
other factors.
    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 the various fragrance 
components identified in Unit II of this document, including exposure 
resulting from the exemptions established by this action. EPA's 
assessment of exposures and risks associated with these 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 the various fragrance components 
identified in Unit II, 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 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 Food Additives 
of the United Nations' (U.N.) Food and Agriculture Organization and the 
World Health Organization (JECFA), 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 Organisation for Economic Co-operation and Development (OECD) 
Quantitative Structure-Activity Relationships (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 27 chemicals had in silico 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 on the chemical or structurally related 
chemicals. Therefore, the TTC method can be applied to these 
fragrances.
    TTCs are derived from a conservative and rigorous approach 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 which correspond to 
the probability of low, moderate and high toxicity) 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.

[[Page 32128]]

    The human exposure threshold value for threshold (i.e., non-cancer) 
risks is based upon Cramer structural class. All of the fragrance 
components listed in Unit II are in Cramer Class I, 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. In evaluating dietary exposure to each of the 
fragrance components listed in Unit II (e.g., ingesting foods that come 
in contact with surfaces treated with pesticide formulations containing 
these fragrance components, and drinking water exposures), EPA 
considered exposure under the proposed exemptions at a concentration 
not to exceed 100 ppm for each of the listed fragrance components as 
well as any other sources of dietary exposure. EPA assessed dietary 
exposures from the fragrance components listed in Unit II 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 U.S. Food and Drug 
Administration guidelines.
    2. 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).
    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 
uses. The Agency's assessment of children's residential exposure 
includes total post-application exposures associated with contact with 
treated indoor surfaces (dermal and hand-to-mouth exposures).
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found the fragrance components listed in Unit II to 
share a common mechanism of toxicity with any other substances, nor do 
they appear to produce a toxic metabolite produced by other substances. 
For the purposes of the tolerance exemptions established in this rule, 
therefore, EPA has assumed that the fragrance components listed in Unit 
II do not have common mechanisms of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
(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 used to derive 
the endpoints (which included developmental and reproductive toxicity 
studies), maternal and developmental-specific 5th percentile NOELs 
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 was selected for 
any of the fragrance components listed in Unit II. Therefore, these 
fragrance components 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 for residential post-application exposure scenarios, 
MOEs ranged from 380 to 7,400. These MOEs are greater than the level of 
concern (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. 
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

[[Page 32129]]

assessment for evaluating intermediate-term risk for these 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 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 
these fragrance components 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 cPAD).
    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

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 fragrance components listed in Unit II of this document in or on 
any food commodities. EPA is, however, establishing limitations on the 
amount of these fragrance components that may be used in antimicrobial 
pesticide formulations. These 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 contains 
these fragrance components in excess of 100 ppm in the final pesticide 
formulation.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of the various fragrance components listed in 
Unit II of this document when used as inert ingredients (fragrance 
components) in pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils with an end-use concentration not to 
exceed 100 ppm under 40 CFR 180.940(a).

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of 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 exemptions in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the National Government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999), and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000), do not apply to this action. In addition, 
this action does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve 
any technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: May 12, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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

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

0
2. Section 180.940 is amended by adding in alphabetical order the 
following inert ingredients to table 1 to paragraph (a):
0
a. Bicyclo(2.2.1)heptan-2-ol, 1,3,3-trimethyl-
0
b. Bicyclo(2.2.1)heptan-2-ol, 1,7,7-trimethyl-,propanoate, exo-
0
c. Bicyclo[3.1.1]heptane, 6,6-dimethyl-2-methylene-
0
d. Butanoic acid, 1,1-dimethyl-2-phenylethyl ester
0
e. [beta]-Caryophyllene
0
f. Celery seed oil
0
g. Citronellal
0
h. Cyclohexene, 1-methyl-4-(1-methylethylidene)-
0
i. p-Cymene
0
j. 2-Decenal

[[Page 32130]]

0
k. Dimethylbenzylcarbinyl acetate
0
l. Elemi oil (Canarium spp.)
0
m. Ethyl (2E,4Z)-2,4-decadienoate
0
n. Galbanum oil (Ferula spp.)
0
o. 2-Hexenal, (2E)-
0
p. 1H-Indole
0
q. Isoborneol
0
r. Isobornyl acetate
0
s. Labdanum oil (Cistus spp.)
0
t. laevo-Bornyl acetate
0
u. Mace oil (Myristica fragrans Houtt.)
0
v. Methyl anthranilate
0
w. Methyl heptine carbonate
0
x. 2-Methyl-3-(p-isopropylphenyl)propionaldehyde
0
y. Methyl N-methylanthranilate
0
z. Methyl 2-nonenoate
0
aa. Methyl 2-nonynoate
0
bb. 2-Methyl-4-phenyl-2-butanol
0
cc. p-Methylanisole
0
dd. Nerolidol (isomer unspecified)
0
ee. Nona-2-trans-6-cis-dienal
0
ff. 2,6-Octadien-1-ol, 3,7-dimethyl-,(Z)-
0
gg. Oil of lemon
0
hh. Oil of lemongrass
0
ii. Oils, clove
0
jj. Oils, ginger
0
kk. Oils, grapefruit
0
ll. Oils, lime
0
mm. Oils, orange, sweet, terpene-free
0
nn. Olibanum oil (Boswellia spp.)
0
oo. Oxacycloheptadec-10-ene-2-one
0
pp. Phenol, 2-methoxy-4-(2-propenyl)-
0
qq. 2-Phenylpropionaldehyde
0
rr. 2-Phenylpropionaldehyde dimethyl acetal
0
ss. [alpha]-Pinene
0
tt. Tangerine oil (Citrus reticulata blanco)
0
uu. [gamma]-Terpinene
0
vv. 1,3,3-trimethyl-2-norbornanyl acetate
0
ww. Ylang-ylang oils.
    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
------------------------------------------------------------------------
 
                              * * * * * * *
Bicyclo(2.2.1)heptan-2-ol,            1632-73-1  When ready for use, the
 1,3,3-trimethyl-.                                end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Bicyclo(2.2.1)heptan-2-ol,            2756-56-1  When ready for use, the
 1,7,7-trimethyl-,propanoate,                     end-use concentration
 exo-.                                            is not to exceed 100
                                                  ppm.
Bicyclo[3.1.1]heptane, 6,6-            127-91-3  When ready for use, the
 dimethyl-2-methylene-.                           end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Butanoic acid, 1,1-dimethyl-2-       10094-34-5  When ready for use, the
 phenylethyl ester.                               end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
[beta]-Caryophyllene...........         87-44-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Celery seed oil................       8015-90-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Citronellal....................        106-23-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Cyclohexene, 1-methyl-4-(1-            586-62-9  When ready for use, the
 methylethylidene)-.                              end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
p-Cymene.......................         99-87-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2-Decenal......................       3913-71-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Dimethylbenzylcarbinyl acetate.        151-05-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Elemi oil (Canarium spp.)......       8023-89-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Ethyl (2E,4Z)-2,4-decadienoate.       3025-30-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Galbanum oil (Ferula spp.).....       8023-91-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 

[[Page 32131]]

 
                              * * * * * * *
2-Hexenal, (2E)-...............       6728-26-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
1H-Indole......................        120-72-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Isoborneol.....................        124-76-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Isobornyl acetate..............        125-12-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Labdanum oil (Cistus spp.).....       8016-26-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
laevo-Bornyl acetate...........       5655-61-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Mace oil (Myristica fragrans          8007-12-3  When ready for use, the
 Houtt.).                                         end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Methyl anthranilate............        134-20-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Methyl heptine carbonate.......        111-12-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2-Methyl-3-(p-                         103-95-7  When ready for use, the
 isopropylphenyl)propionaldehyd                   end-use concentration
 e.                                               is not to exceed 100
                                                  ppm.
Methyl N-methylanthranilate....         85-91-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Methyl 2-nonenoate.............        111-79-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Methyl 2-nonynoate.............        111-80-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2-Methyl-4-phenyl-2-butanol....        103-05-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
p-Methylanisole................        104-93-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Nerolidol (isomer unspecified).       7212-44-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Nona-2-trans-6-cis-dienal......        557-48-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2,6-Octadien-1-ol, 3,7-dimethyl-       106-25-2  When ready for use, the
 ,(Z)-.                                           end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Oil of lemon...................       8008-56-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

[[Page 32132]]

 
Oil of lemongrass..............       8007-02-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Oils, clove....................       8000-34-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Oils, ginger...................       8007-08-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Oils, grapefruit...............       8016-20-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Oils, lime.....................       8008-26-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Oils, orange, sweet, terpene-        68606-94-0  When ready for use, the
 free.                                            end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Olibanum oil (Boswellia spp.)..       8016-36-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Oxacycloheptadec-10-ene-2-one..      28645-51-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Phenol, 2-methoxy-4-(2-                 97-53-0  When ready for use, the
 propenyl)-.                                      end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
2-Phenylpropionaldehyde........         93-53-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
2-Phenylpropionaldehyde                 90-87-9  When ready for use, the
 dimethyl acetal.                                 end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
[alpha]-Pinene.................         80-56-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Tangerine oil (Citrus                 8008-31-9  When ready for use, the
 reticulata blanco).                              end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
[gamma]-Terpinene..............         99-85-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
1,3,3-trimethyl-2-norbornanyl        13851-11-1  When ready for use, the
 acetate.                                         end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
Ylang-ylang oils...............       8006-81-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-10550 Filed 5-18-23; 8:45 am]
BILLING CODE 6560-50-P