Rule2023-10550
Various Fragrance Components in Pesticide Formulations; Tolerance Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 19, 2023
Effective
May 19, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes 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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 97 (Friday, May 19, 2023)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10550]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection
[[Page 32126]]
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main
telephone number: (202) 566-1030; email address: <a href="/cdn-cgi/l/email-protection#b4e6f0f2e6fadbc0ddd7d1c7f4d1c4d59ad3dbc2"><span class="__cf_email__" data-cfemail="affdebe9fde1c0dbc6cccadcefcadfce81c8c0d9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets#express">https://www.epa.gov/dockets/where-send-comments-epa-dockets#express</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of 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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in
response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
[[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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 19, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.