Rule2022-15017
Various Fragrance Components; Exemptions From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 21, 2022
Effective
July 21, 2022
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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 139 (Thursday, July 21, 2022)</title>
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[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Rules and Regulations]
[Pages 43420-43427]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15017]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0296; FRL-9924-01-OCSPP]
Various Fragrance Components; Exemptions From the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of various fragrance components listed in unit
II of this document when they are used as inert ingredients in
antimicrobial pesticide formulations for use on food contact surfaces
in public eating places, dairy processing equipment, and food
processing equipment and utensils with end-use concentration not to
exceed 100 parts per million (ppm). Verto Solutions on behalf of The
Clorox Company submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting the establishment of such
exemptions from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of various fragrance components.
DATES: This regulation is effective July 21, 2022. Objections and
requests for hearings must be received on or before September 19, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0296, is available at
<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: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#6b392f2d3925041f02080e182b0e1b0a450c041d"><span class="__cf_email__" data-cfemail="e7b5a3a1b5a988938e848294a7829786c9808891">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<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, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0296 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
September 19, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0296, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <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/contacts.html">https://www.epa.gov/dockets/contacts.html</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 June 24, 2020 (85 FR 37807) (FRL-10010-
82), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11018) by
Verto Solutions on behalf of The Clorox Company, 4900 Johnson Dr.,
Pleasanton, CA 94588. The petition requested that 40 CFR 180.940(a) be
amended by
[[Page 43421]]
establishing an exemption from the requirement of a tolerance for
residues of acetaldehyde ethyl cis- 3-hexenyl acetal (CAS Reg. No.
28069-74-1), (tri-)acetin (CAS Reg. No. 102-76-1), acetophenone (CAS
Reg. No. 98-86-2), allyl alpha-ionone (CAS Reg. No. 79-78-7),
benzaldehyde (CAS Reg. No. 100-52-7), benzyl alcohol (CAS Reg. No. 100-
51-6), benzyl butyrate (CAS Reg. No. 103-37-7), benzyl isobutyrate (CAS
Reg. No. 103-28-6), benzyl propionate (CAS Reg. No. 122-63-4),
carvacrol (CAS Reg. No. 499-75-2), cinnamaldehyde (CAS Reg. No. 104-55-
2), cinnamyl alcohol (CAS Reg. No. 104-54-1), cuminaldehyde (CAS Reg.
No. 122-03-2), diethyl malonate (CAS Reg. No. 105-53-3), 1,1-diethoxy-
3,7- dimethylocta-2,6-diene (CAS Reg. No. 7492-66-2), dihydro-beta-
ionone (CAS Reg. No. 17283-81-7), dihydrocarvyl acetate (CAS Reg. No.
20777-49-5), ethyl acetoacetate (CAS Reg. No. 141-97-9), ethyl benzoate
(CAS Reg. No. 93-89-0), ethylene brassylate (CAS Reg. No. 105-95-3),
ethyl salicylate (CAS Reg. No. 118-61-6), 4-formy-l-2- methoxyphenyl 2-
methylpropanoate; vanillin isobutyrate (CAS Reg. No. 20665-85-4),
hydroxycitronellal (CAS Reg. No. 107-75-5), hydroxycitronellol (CAS
Reg. No. 107-74-4), 4-(p-hydroxyphenyl)-2- butanone (CAS Reg. No. 5471-
51-2), p-methoxybenzaldehyde (CAS Reg. No. 123-11-5), 2-methoxy-4-
propylphenol (CAS Reg. No. 2785-87-7), 4'-methylacetophenone (CAS Reg.
No. 122-00-9), alpha-methylbenzyl acetate (CAS Reg. No. 93-92-5),
alpha-methylbenzyl alcohol (CAS Reg. No. 98-85-1), methyl benzoate (CAS
Reg. No. 93-58-3), alpha- methylcinnamaldehyde (CAS Reg. No. 101-39-3),
methyl cinnamate (CAS Reg. No. 103-26-4), 5-methyl-2-hepten-4- one (CAS
Reg. No. 81925-81-7), alpha-iso-methylionone (CAS Reg. No. 127-51-5),
methyl salicylate (CAS Reg. No. 119-36-8), cis-6-nonenal (CAS Reg. No.
2277-19-2), cis-6-nonen-1-ol (CAS Reg. No. 35854-86-5), octanal
dimethyl acetal (CAS Reg. No. 10022-28-3), phenethyl acetate (CAS Reg.
No. 103-45-7), phenethyl alcohol (CAS Reg. No. 60-12-8), phenethyl
isobutyrate (CAS Reg. No. 103-48-0), phenethyl phenylacetate (CAS Reg.
No. 102-20-5), phenylacetaldehyde dimethyl acetal (CAS Reg. No. 101-48-
4), 3-phenyl-1-propanol (CAS Reg. No. 122-97-4), 1-(2,6,6-
trimethylcyclohexa-1,3- dienyl)-2-buten-1-one (CAS Reg. No. 23696-85-
7), delta-1-(2,6,6-trimethyl- 3-cyclohexen-1-yl)-2- buten-1-one (CAS
Reg. No. 57378-68-4), triethyl citrate (CAS Reg. No. 77-93-0),
thiogeraniol (CAS Reg. No. 39067-80-6), thymol (CAS Reg. No. 89-83-8),
vanillin (CAS Reg. No. 121-33-5), veratraldehyde (CAS Reg. No. 120-14-
9) when used as an inert ingredient fragrance component in pesticide
formulations applied to food contact surfaces in public eating places,
dairy processing equipment, and food processing equipment with end-use
concentrations not to exceed 100 ppm. That document referenced a
summary of the petition prepared by Verto Solutions on behalf of The
Clorox Company, the petitioner, which is available in the docket,
<a href="https://www.regulations.gov/docket/EPA-HQ-OPP-2020-0296">https://www.regulations.gov/docket/EPA-HQ-OPP-2020-0296</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;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for various fragrance components
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with various
fragrance components follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received for the various
fragrance components are discussed in this unit.
The Agency assessed these fragrance components via the Threshold of
Toxicological Concern (TTC) approach as outlined by the European Food
Safety Authority (EFSA) in their 2019 guidance document on the use of
TTC in food safety assessment. Information regarding the database of
studies and chemicals used to derive TTCs are reviewed therein. The TTC
approach has been used by the Joint Expert Committee on
[[Page 43422]]
Food Additives of the U.N.'s Food and Agriculture Organization and the
World Health Organization, the former Scientific Committee on Food of
the European Commission, the European Medicines Agency, and EFSA.
Information from JECFA reports as well as predictive toxicology
using the OECD QSAR Toolbox was used to confirm that the fragrances
listed in Unit II have low carcinogenic potential and are thus good
candidates for the application of the TTC method. Although 13 chemicals
had carcinogenicity alerts, JECFA concluded and EPA concurs that all
fragrances listed in unit II have low carcinogenic potential, based on
in vitro and/or in vivo genotoxicity studies available. Therefore, the
TTC method can be applied to these fragrances.
TTCs are derived from a conservative and rigorous approach
developed by Munro and Kroes to establish generic threshold values for
human exposure at which a very low probability of adverse effects is
likely. By comparing a range of compounds by Cramer Class (classes I,
II, and III) and NOEL (no-observed-effect-level), fifth percentile
NOELs were established for each Cramer Class as ``Human Exposure
Thresholds''. These values were 3, 0.91 and 0.15 mg/kg/day for classes
I, II, and III, respectively.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <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>.
The human exposure threshold value for threshold (i.e., non-cancer)
risks is based upon Cramer structural class. In the case of the
fragrance components listed above, all the substances included are in
the Cramer Class I category, which is defined as chemicals of simple
structure and efficient modes of metabolism, suggesting low oral
toxicity.
Therefore, the NOEL of 3 mg/kg/day is selected as the point of
departure for all exposure scenarios assessed (chronic dietary,
incidental oral, dermal and inhalation exposures).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Dietary exposure (food
and drinking water) may occur from the existing (non-food) and proposed
uses of fragrance components listed in unit II (e.g., eating foods
treated with pesticide formulations containing these fragrances, and
drinking water exposures). In evaluating dietary exposure to each of
the fragrance components listed in Unit II, EPA considered exposure
under the proposed tolerance exemptions at a concentration not to
exceed 100 ppm for each of the fragrance components listed in Unit II.
as well as any other sources of dietary exposure. EPA assessed dietary
exposures from various fragrance components in food as follows:
The dietary assessment for food contact sanitizer solutions
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake
(EDI). The assessment considered: Application rates, residual solution
or quantity of solution remaining on the treated surface without
rinsing with potable water, surface area of the treated surface which
comes into contact with food, pesticide migration fraction, and body
weight. These assumptions are based on Food and Drug Administration
(FDA) guidelines.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for various fragrance
components a conservative drinking water concentration value of 100 ppb
based on screening level modeling was used to assess the contribution
to drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
3. Residential exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., textiles (clothing and diapers), carpets, swimming pools, and
hard surface disinfection on walls, floors, tables). The fragrance
components listed in Unit II may be used as inert ingredients in
products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home.
The Agency conducted a conservative assessment of potential residential
exposure by assessing various fragrance components in disinfectant-type
uses (indoor scenarios). The Agency's assessment of adult residential
exposure combines high-end dermal and inhalation handler exposure from
indoor hard surface, wiping and aerosol spray. The Agency's assessment
of children's residential exposure includes total post-application
exposures associated with total exposures associated with contact with
treated indoor surfaces (dermal and hand-to-mouth exposures).
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not made a common mechanism of toxicity finding as to these
fragrance chemicals listed in unit II and any other substances, and
these fragrance chemicals do not appear to produce toxic metabolites
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that these fragrance chemicals
listed in unit II have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
D. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
[[Page 43423]]
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor. The FQPA SF
has been reduced to 1X in this risk assessment because clear NOELs and
LOELs were established in the studies analyzed by Munro et al 1996
(which included developmental and reproductive toxicity studies),
maternal and developmental-specific 5th percentile NOAELs calculated by
van Ravenzwaay et al 2011 indicate low potential for offspring
susceptibility, and the conservative assumptions made in the exposure
assessment are unlikely to underestimate risk.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute aggregate risk. An acute aggregate risk assessment takes
into account acute exposure estimates from dietary consumption of food
and drinking water. No adverse effects resulting from a single oral
exposure were identified and no acute dietary endpoint were selected
for any of the fragrance components. Therefore, the fragrance
components listed in Unit II are not expected to pose an acute risk.
2. Short-term aggregate risk. Short-term aggregate exposure takes
into account short-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level). For
residential handler short-term exposure scenarios, MOEs ranged from 140
to 2,500, while residential post-application exposure scenarios MOEs
ranged from 380 to 7,400. These MOEs are greater than the LOC of 100
and therefore are not of concern. The short-term aggregate MOE is 109
for adults and 135 for children, which are greater than the LOC of 100
and therefore are not of concern.
3. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
the fragrance components listed in Unit II are not currently used as an
inert ingredient in pesticide products that are registered for any use
patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for various fragrance components.
4. Chronic aggregate risk. Using the exposure assumptions described
in this unit for chronic exposure, EPA has concluded that chronic
exposure to the fragrance components listed in Unit II from food and
water will utilize 19% of the chronic PAD (cPAD) for the U.S.
population and 48% of the cPAD for children 1 to 2 years old, the
population group receiving the greatest exposure. Chronic residential
exposure to residues of benoxacor is not expected. Therefore, the
chronic aggregate risk is equal to the chronic dietary exposure for
children 1 to 2 years old (48% of the PAD).
5. Aggregate cancer risk for U.S. population. There is low concern
for genotoxicity/carcinogenicity in humans for the fragrance components
listed in Unit II of this document. Therefore, the assessment under the
TTC value for non-cancer risks is protective for all risks, including
carcinogenicity.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of the fragrance components listed in Unit II.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for fragrances
listed in unit II of this document in or on any food commodities. EPA
is establishing a limitation on the amount of the fragrances listed in
unit II that may be used in antimicrobial pesticide formulations. This
limitations will be enforced through the pesticide registration process
under the Federal Insecticide, Fungicide, and Rodenticide Act
(``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register any pesticide
formulation for food use that exceeds 100ppm of fragrances listed in
unit II in the final pesticide formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for the fragrance components
listed in Unit II.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for acetaldehyde ethyl cis- 3-
hexenyl acetal (CAS Reg. No. 28069-74-1), (tri-)acetin (CAS Reg. No.
102-76-1), acetophenone (CAS Reg. No. 98-86-2), allyl alpha-ionone (CAS
Reg. No. 79-78-7), benzaldehyde (CAS Reg. No. 100-52-7), benzyl alcohol
(CAS Reg. No. 100-51-6), benzyl butyrate (CAS Reg. No. 103-37-7),
benzyl isobutyrate (CAS Reg. No. 103-28-6), benzyl propionate (CAS Reg.
No. 122-63-4), carvacrol (CAS Reg. No. 499-75-2), cinnamic aldehyde
(cinnamaldehyde) (CAS Reg. No. 104-55-2), cinnamic alcohol (cinnamyl
alcohol) (CAS Reg. No. 104-54-1), cuminaldehyde (CAS Reg. No. 122-03-
2), diethyl malonate (CAS Reg. No. 105-53-3), 1,1-diethoxy-3,7-
dimethylocta-2,6-diene (CAS Reg. No. 7492-66-2), dihydro-beta-ionone
(CAS Reg. No. 17283-81-7), dihydrocarvyl acetate (CAS Reg. No. 20777-
49-5), butanoic acid, 3-oxo-, ethyl ester (ethyl acetoacetate) (CAS
Reg. No. 141-97-9),
[[Page 43424]]
benzoic acid, ethyl ester (ethyl benzoate) (CAS Reg. No. 93-89-0),
ethylene brassylate (CAS Reg. No. 105-95-3), ethyl salicylate (CAS Reg.
No. 118-61-6), propanoic acid, 2-methyl-, 4-formyl-2-methoxyphenyl
ester (4-formy-l-2- methoxyphenyl 2- methylpropanoate; vanillin
isobutyrate) (CAS Reg. No. 20665-85-4), hydroxycitronellal (CAS Reg.
No. 107-75-5), hydroxycitronellol (CAS Reg. No. 107-74-4), 4-(p-
hydroxyphenyl)-2- butanone (CAS Reg. No. 5471-51-2), benzaldehyde, 4-
methoxy- (p-methoxybenzaldehyde) (CAS Reg. No. 123-11-5), 2-methoxy-4-
propylphenol (CAS Reg. No. 2785-87-7), 4'-methylacetophenone (CAS Reg.
No. 122-00-9), benzenemethanol, alpha-methyl-, 1-acetate (alpha-
methylbenzyl acetate) (CAS Reg. No. 93-92-5), alpha-methylbenzyl
alcohol (CAS Reg. No. 98-85-1), methyl benzoate (CAS Reg. No. 93-58-3),
alpha- methylcinnamaldehyde (CAS Reg. No. 101-39-3), methyl cinnamate
(CAS Reg. No. 103-26-4), 2-hepten-4-one, 5-methyl- (5-methyl-2-hepten-
4- one) (CAS Reg. No. 81925-81-7), 3-buten-2-one, 3-methyl-4-(2,6,6-
trimethyl-2-cyclohexen-1-yl)- (alpha-iso-methylionone) (CAS Reg. No.
127-51-5), methyl salicylate (CAS Reg. No. 119-36-8), 6-nonenal, (6Z)-
(cis-6-nonenal) (CAS Reg. No. 2277-19-2), cis-6-nonen-1-ol (CAS Reg.
No. 35854-86-5), octanal dimethyl acetal (CAS Reg. No. 10022-28-3),
phenethyl acetate (CAS Reg. No. 103-45-7), phenyl ethyl alcohol
(phenethyl alcohol) (CAS Reg. No. 60-12-8), phenethyl isobutyrate (CAS
Reg. No. 103-48-0), phenethyl phenylacetate (CAS Reg. No. 102-20-5),
phenylacetaldehyde dimethyl acetal (CAS Reg. No. 101-48-4), 3-phenyl-1-
propanol (CAS Reg. No. 122-97-4), 2-buten-1-one, 1-(2,6,6-trimethyl-
1,3-cyclohexadien-1-yl)- (1-(2,6,6-trimethylcyclohexa-1,3- dienyl)-2-
buten-1-one (CAS Reg. No. 23696-85-7), delta-1-(2,6,6-trimethyl- 3-
cyclohexen-1-yl)-2- buten-1-one (CAS Reg. No. 57378-68-4), triethyl
citrate (CAS Reg. No. 77-93-0), thiogeraniol (CAS Reg. No. 39067-80-6),
thymol (8CA) (thymol) (CAS Reg. No. 89-83-8), vanillin (CAS Reg. No.
121-33-5), veratraldehyde (CAS Reg. No. 120-14-9) when used as an inert
ingredient (fragrance components) in pesticide formulations applied to
food contact surfaces in public eating places, dairy processing
equipment, and food processing equipment and utensils with end-use
concentration not to exceed 100 ppm.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 8, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICALS
RESIDUES IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.940 is amended by adding in alphabetical order the
following inert ingredients to table 1 to paragraph (a):
0
a. acetaldehyde ethyl cis-3-hexenyl acetal
0
b. Acetophenone
0
c. allyl alpha-ionone
0
d. Benzaldehyde
0
e. benzyl alcohol
0
f. benzyl butyrate
0
g. benzyl isobutyrate
0
h. benzaldehyde, 4-methoxy-
0
i. benzenemethanol, alpha-methyl-, 1-acetate
0
j. benzoic acid, ethyl ester
0
k. butanoic acid, 3-oxo-, ethyl ester
0
l. 2-buten-1-one, 1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-
0
m. 3-buten-2-one, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-
0
n. Carvacrol
0
o. cinnamic aldehyde
[[Page 43425]]
0
p. cinnamic alcohol
0
q. Cuminaldehyde
0
r. diethyl malonate
0
s. 1,1-diethoxy-3,7-dimethylocta-2,6-diene
0
t. dihydro-beta-ionone
0
u. dihydrocarvyl acetate
0
v. ethylene brassylate
0
w. ethyl salicylate
0
x. glyceryl triacetate
0
y. 2-hepten-4-one, 5-methyl-
0
z. Hydroxycitronellal
0
aa. Hydroxycitronellol
0
bb. 4-(p-hydroxyphenyl)-2-butanone
0
cc. 2-methoxy-4-propylphenol
0
dd. methyl benzoate
0
ee. 4'-methylacetophenone
0
ff. alpha-methylbenzyl alcohol
0
gg. alpha-methylcinnamaldehyde
0
hh. methyl cinnamate
0
ii. methyl salicylate
0
jj. 6-nonenal, (6Z)-
0
kk. cis-6-nonen-1-ol
0
ll. octanal dimethyl acetal
0
mm. phenethyl acetate
0
nn. phenyl ethyl alcohol
0
oo. phenethyl isobutyrate
0
pp. phenethyl phenylacetate
0
qq. phenylacetaldehyde dimethyl acetal
0
rr. 3-phenyl-1-propanol
0
ss. propanoic acid, 2-methyl-, 4-formyl-2-methoxyphenyl ester
0
tt. triethyl citrate
0
uu. delta-1-(2,6,6-trimethyl-3-cyclohexen-1-yl)-2-buten-1-
0
vv. Thiogeraniol
0
ww. thymol (8CA)
0
xx. Vanillin
0
yy. veratraldehyde
The additions read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
acetaldehyde ethyl cis-3- 28069-74-1 When ready for use, the
hexenyl acetal. end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Acetophenone................... 98-86-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
allyl alpha-ionone............. 79-78-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Benzaldehyde................... 100-52-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
benzyl alcohol................. 100-51-6 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
benzyl butyrate................ 103-37-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
benzyl isobutyrate............. 103-28-6 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
benzyl propionate.............. 122-63-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
benzaldehyde, 4-methoxy-....... 123-11-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
benzenemethanol, alpha-methyl-, 93-92-5 When ready for use, the
1-acetate. end-use concentration
is not to exceed 100
ppm.
* * * * * * *
benzoic acid, ethyl ester...... 93-89-0 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
butanoic acid, 3-oxo-, ethyl 141-97-9 When ready for use, the
ester. end-use concentration
is not to exceed 100
ppm.
* * * * * * *
2-buten-1-one, 1-(2,6,6- 23696-85-7 When ready for use, the
trimethyl-1,3-cyclohexadien-1- end-use concentration
yl)-. is not to exceed 100
ppm.
* * * * * * *
3-buten-2-one, 3-methyl-4- 127-51-5 When ready for use, the
(2,6,6-trimethyl-2-cyclohexen- end-use concentration
1-yl)-. is not to exceed 100
ppm.
* * * * * * *
Carvacrol...................... 499-75-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
cinnamic aldehyde.............. 104-55-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
cinnamic alcohol............... 104-54-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
[[Page 43426]]
* * * * * * *
Cuminaldehyde.................. 122-03-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
diethyl malonate............... 105-53-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
1,1-diethoxy-3,7-dimethylocta- 7492-66-2 When ready for use, the
2,6-diene. end-use concentration
is not to exceed 100
ppm.
* * * * * * *
dihydro-beta-ionone............ 17283-81-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
dihydrocarvyl acetate.......... 20777-49-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
ethylene brassylate............ 105-95-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
ethyl salicylate............... 118-61-6 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
glyceryl triacetate............ 102-76-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
2-hepten-4-one, 5-methyl-...... 81925-81-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Hydroxycitronellal............. 107-75-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Hydroxycitronellol............. 107-74-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
4-(p-hydroxyphenyl)-2-butanone. 5471-51-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
2-methoxy-4-propylphenol....... 2785-87-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
methyl benzoate................ 93-58-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
4'-methylacetophenone.......... 122-00-9 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
alpha-methylbenzyl alcohol..... 98-85-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
alpha-methylcinnamaldehyde..... 101-39-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
methyl cinnamate............... 103-26-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
methyl salicylate.............. 119-36-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
6-nonenal, (6Z)-............... 2277-19-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
cis-6-nonen-1-ol............... 35854-86-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
octanal dimethyl acetal........ 10022-28-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
phenethyl acetate.............. 103-45-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
phenyl ethyl alcohol........... 60-12-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
[[Page 43427]]
* * * * * * *
phenethyl isobutyrate.......... 103-48-0 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
phenethyl phenylacetate........ 102-20-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
phenylacetaldehyde dimethyl 101-48-4 When ready for use, the
acetal. end-use concentration
is not to exceed 100
ppm.
* * * * * * *
3-phenyl-1-propanol............ 122-97-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
propanoic acid, 2-methyl-, 4- 20665-85-4 When ready for use, the
formyl-2-methoxyphenyl ester. end-use concentration
is not to exceed 100
ppm.
* * * * * * *
triethyl citrate............... 77-93-0 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
delta-1-(2,6,6-trimethyl-3- 57378-68-4 When ready for use, the
cyclohexen-1-yl)-2-buten-1-one. end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Thiogeraniol................... 39067-80-6 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
thymol (8CA)................... 89-83-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Vanillin....................... 121-33-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
veratraldehyde................. 120-14-9 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2022-15017 Filed 7-20-22; 8:45 am]
BILLING CODE 6560-50-P
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