Rule2021-27580
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
December 22, 2021
Effective
December 22, 2021
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
<html>
<head>
<title>Federal Register, Volume 86 Issue 243 (Wednesday, December 22, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Rules and Regulations]
[Pages 72525-72531]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27580]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0294; FRL-9226-01-OCSPP]
Various Fragrance Components; Exemptions From the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of various fragrance components listed in unit
II of this document when they are used as inert ingredients in
antimicrobial pesticide formulations for use on food contact surfaces
in public eating places, dairy processing equipment, and food
processing equipment and utensils with end-use concentration not to
exceed 100 parts per million (ppm). Verto Solutions on behalf of The
Clorox Company submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting the establishment of such
exemptions from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of various fragrance components.
DATES: This regulation is effective December 22, 2021. Objections and
requests for hearings must be received on or before February 22, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0294, is available at
<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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit <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: (703) 305-7090; email address:
<a href="/cdn-cgi/l/email-protection#94c6d0d2c6dafbe0fdf7f1e7d4f1e4f5baf3fbe2"><span class="__cf_email__" data-cfemail="12405654405c7d667b717761527762733c757d64">[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-2020-0294 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 22, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0294, by one of
the following methods:
<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-11016) by
Verto Solutions on behalf of The Clorox Company, 4900 Johnson Dr.,
Pleasanton, CA 94588. The petition requested that 40 CFR 180.940(a) be
amended by
[[Page 72526]]
establishing an exemption from the requirement of a tolerance for
residues of [delta]-decalactone (CAS Reg. No. 705-86-2), [gamma]-
decalactone (CAS Reg. No. 706-14-9), dimethyl-1-octanol (CAS Reg. No.
106-21-8), 3,7, ethyl acetate (CAS Reg. No. 141-78-6), ethyl butyrate
(CAS Reg. No. 105-54-4), ethyl decanoate (CAS Reg. No. 110-38-3); ethyl
heptanoate (CAS Reg. No. 106-30-9), ethyl hexanoate (CAS Reg. No. 123-
66-0), ethyl isobutyrate (CAS Reg. No. 97-62-1), ethyl laurate (CAS
Reg. No. 106-33-2), ethyl octanoate (CAS Reg. No. 106-32-1), ethyl
nonanoate (CAS Reg. No. 123-29-5), [gamma]-heptalactone (CAS Reg. No.
105-21-5), [gamma]-hexalactone (CAS Reg. No. 695-06-7), cis-3-hexenyl
butyrate (CAS Reg. No. 16491-36-4), cis-3-hexenyl hexanoate (CAS Reg.
No. 31501-11-8), 3-hexenyl 2-methylbutanoate (CAS Reg. No. 10094-41-4),
hexyl butyrate (CAS Reg. No. 2639-63-6), hexyl hexanoate (CAS Reg. No.
6378-65-0), hexyl isobutyrate (CAS Reg. No. 2349-07-7), hexyl
propionate (CAS Reg. No. 2445-76-3), hydroxynonanoic acid, [delta]-
lactone (CAS Reg. No. 3301-94-8), 5-hydroxyundecanoic acid lactone (CAS
Reg. No. 710-04-3), isoamyl acetate (CAS Reg. No. 123-92-2), isoamyl
alcohol (CAS Reg. No. 123-51-3), isoamyl butyrate (CAS Reg. No. 106-27-
4), isobutyl acetate (CAS Reg. No. 110-19-0), isobutyl isobutyrate (CAS
Reg. No. 97-85-8), isopropyl 2-methylbutyrate (CAS Reg. No. 66576-71-
4), Lavandin oil (Lavandula hybrida) (CAS Reg. No. 8022-15-9), linalool
(CAS Reg. No. 78-70-6), linalyl acetate (CAS Reg. No.115-95-7),
[gamma]-nonalactone (CAS Reg. No. 104-61-0), [gamma]-octalactone (CAS
Reg. No. 104-50-7), [omega]-pentadecalactone (CAS Reg. No. 106-02-5),
Petitgrain bigarade oil (CAS Reg. No. 8014-17-3), [alpha]-terpineol
(CAS Reg. No. 98-55-5), terpinyl acetate (isomer mixture) (CAS Reg. No.
8007-35-0), Tetrahydrolinalool (CAS Reg. No. 78-69-3), [gamma]-
undecalactone (CAS Reg. No. 104-67-6), 10-undecen-1-yl acetate (CAS
Reg. No. 112-19-6) when used as an inert ingredient fragrance component
in pesticide formulations applied to food contact surfaces in public
eating places, dairy processing equipment, and food processing
equipment with end-use concentrations not to exceed 100 ppm. That
document referenced a summary of the petition prepared by Verto
Solutions on behalf of The Clorox Company, the petitioner, which is
available in the docket, <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;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for various fragrance components
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with various
fragrance components follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by various fragrance components as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
The Agency assessed these fragrance components via the Threshold of
toxicological concern (TTC) approach as outlined by the European Food
Safety Authority (EFSA) in their 2018 proposed guidance document on the
use of TTC in food safety assessment. This approach relies on the most
recent evaluation of the literature on TTC as reviewed by EFSA and the
World Health Organization (WHO) in 2016. Information regarding the
database of studies and chemicals used to derive TTCs are reviewed
therein. The TTC approach has been used by the Joint Expert Committee
on Food Additives of the United Nation's Food and Agriculture
Organization and the World Health Organization, the former Scientific
Committee on Food of the European Commission, the European Medicines
Agency, and EFSA.
Thresholds of toxicological concern (TTC) are derived from a
conservative and rigorous approach developed by
[[Page 72527]]
Munro and Kroes (Munro et al. 1996) to establish generic threshold
values for human exposure at which a very low probability of adverse
effects is likely. By comparing a range of compounds by their structure
using the Cramer classification scheme, i.e., Cramer Class (Cramer et
al. 1978), and NOEL (no-observed-effect-level), fifth percentile NOELs
were established for each Cramer Class as ``Human Exposure Thresholds''
assuming a 60 kg human. These determined values were 30, 9, and 1.5
[mu]g/kg/day for Cramer Class I, II, and III, respectively.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticides/factsheets/riskassess.htm">https://www.epa.gov/pesticides/factsheets/riskassess.htm</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. The corresponding TTC value for substances in the Cramer
Class I category is 30 [mu]g/kg/day, which is based on a 5th percentile
NOEL of 3 mg/kg/day.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to each of the fragrance components listed in Unit II, EPA
considered exposure under the proposed tolerance exemptions at a
concentration not to exceed 100 ppm for each of the fragrance
components listed in Unit II. as well as any other sources of dietary
exposure. EPA assessed dietary exposures from various fragrance
components in food as follows:
The dietary assessment for food contact sanitizer solutions
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake
(EDI). The assessment considered: Application rates, residual solution
or quantity of solution remaining on the treated surface without
rinsing with potable water, surface area of the treated surface which
comes into contact with food, pesticide migration fraction, and body
weight. These assumptions are based on Food and Drug Administration
(FDA) guidelines.
The dietary assessment for food contact sanitizer solutions showed
that children 1 to 2 years old would be the highest exposed subgroup
(48% of the chronic PAD (cPAD)). The general U.S. population resulted
in 19% of the cPAD. Any percent cPAD exceeding 100% would be of
concern.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for various fragrance
components a conservative drinking water concentration value of 100 ppb
based on screening level modeling was used to assess the contribution
to drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Various fragrance components may be used as inert ingredients in
products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home.
The Agency conducted a conservative assessment of potential residential
exposure by assessing various fragrance components in pesticide in
disinfectant-type uses (indoor scenarios). The Agency's assessment of
adult residential exposure combines high-end dermal and inhalation
handler exposure from indoor hard surface, wiping and aerosol spray.
The Agency's assessment of children's residential exposure includes
total post-application exposures associated with total exposures
associated with contact with treated indoor surfaces (dermal and hand-
to-mouth exposures.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not made a common
mechanism of toxicity finding as to these fragrance chemicals listed in
unit II and any other substances, and these fragrance chemicals do not
appear to produce toxic metabolites produced by other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that these fragrance chemicals listed in unit II have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at <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
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) safety factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor. The FQPA SF has been reduced to 1X in this risk
assessment because clear NOELs and LOELs were established in the
studies analyzed by Munro et al. 1996 (which included developmental and
reproductive toxicity studies), maternal and
[[Page 72528]]
developmental-specific 5th percentile NOAELs calculated by van
Ravenzwaay et al. 2011 indicate low potential for offspring
susceptibility, and the conservative assumptions made in the exposure
assessment are unlikely underestimate risk.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effects resulting from a single oral
exposure were identified and no acute dietary endpoint were selected
for any of the fragrance components. Therefore, the fragrance
components listed in Unit II are not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
the fragrance components listed in Unit II from food and water will
utilize 48% of the cPAD for children 1 to 2 years old, the population
group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
The fragrance components listed in Unit II are currently used as an
inert ingredient in pesticide products that are registered for uses
that could result in short-term residential exposure, and the Agency
has determined that it is appropriate to aggregate chronic exposure
through food and water with short-term residential exposures to the
fragrance components listed in Unit II.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 109 for both
adult males and females. EPA has concluded the combined short-term
aggregated food, water, and residential pesticide exposures result in
an aggregate MOE of 135 for children. Because EPA's level of concern
for the fragrance components listed in Unit II of this document is an
MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
the fragrance components listed in Unit II are not currently used as an
inert ingredient in pesticide products that are registered for any use
patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for various fragrance components.
5. Aggregate cancer risk for U.S. population. No structural alerts
for cancer that are relevant to humans were identified for the
fragrance components listed in Unit II Therefore, there is low concern
for genotoxicity/carcinogenicity in humans and the assessment under the
TTC value for non-cancer risks is protective for all risks, including
carcinogenicity.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of the fragrance components listed in Unit II.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
the fragrances listed in unit II in or on any food commodities. EPA is
establishing a limitation on the amount of the fragrances listed in
unit II that may be used in pesticide formulations. This limitation
will be enforced through the pesticide registration process under the
Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7
U.S.C. 136 et seq. EPA will not register any pesticide formulation for
food use that exceeds 100 ppm of any one of the fragrances listed in
unit II in the final pesticide formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for the fragrance components
listed in Unit II.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for [delta]-decalactone (CAS Reg.
No. 705-86-2), [gamma]-decalactone (CAS Reg. No. 706-14-9), dimethyl-1-
octanol (CAS Reg. No. 106-21-8), 3,7, ethyl acetate (CAS Reg. No. 141-
78-6), ethyl butyrate (CAS Reg. No. 105-54-4), ethyl decanoate (CAS
Reg. No. 110-38-3); ethyl heptanoate (CAS Reg. No. 106-30-9), ethyl
hexanoate (CAS Reg. No. 123-66-0), ethyl isobutyrate (CAS Reg. No. 97-
62-1), ethyl laurate (CAS Reg. No. 106-33-2), ethyl octanoate (CAS Reg.
No. 106-32-1), ethyl nonanoate (CAS Reg. No. 123-29-5), [gamma]-
heptalactone (CAS Reg. No. 105-21-5), [gamma]-hexalactone (CAS Reg. No.
695-06-7), cis-3-hexenyl butyrate (CAS Reg. No. 16491-36-4), cis-3-
hexenyl hexanoate (CAS Reg. No. 31501-11-8), 3-hexenyl 2-
methylbutanoate (CAS Reg. No. 10094-41-4), hexyl butyrate (CAS Reg. No.
2639-63-6), hexyl hexanoate (CAS Reg. No. 6378-65-0), hexyl isobutyrate
(CAS Reg. No. 2349-07-7), hexyl propionate (CAS Reg. No. 2445-76-3),
hydroxynonanoic acid, [delta]-lactone (CAS Reg. No. 3301-94-8), 5-
hydroxyundecanoic acid lactone (CAS Reg. No. 710-04-3), isoamyl acetate
(CAS Reg. No. 123-92-2), isoamyl alcohol (CAS Reg. No. 123-51-3),
isoamyl butyrate (CAS Reg. No. 106-27-
[[Page 72529]]
4), isobutyl acetate (CAS Reg. No. 110-19-0), isobutyl isobutyrate (CAS
Reg. No. 97-85-8), isopropyl 2-methylbutyrate (CAS Reg. No. 66576-71-
4), Lavandin oil (Lavandula hybrida) (CAS Reg. No. 8022-15-9), linalool
(CAS Reg. No. 78-70-6), linalyl acetate (CAS Reg. No.115-95-7),
[gamma]-nonalactone (CAS Reg. No. 104-61-0), [gamma]-octalactone (CAS
Reg. No. 104-50-7), [omega]-pentadecalactone (CAS Reg. No. 106-02-5),
Petitgrain bigarade oil (CAS Reg. No. 8014-17-3), [alpha]-terpineol
(CAS Reg. No. 98-55-5), terpinyl acetate (isomer mixture) (CAS Reg. No.
8007-35-0), Tetrahydrolinalool (CAS Reg. No. 78-69-3), [gamma]-
undecalactone (CAS Reg. No. 104-67-6), 10-undecen-1-yl acetate (CAS
Reg. No. 112-19-6) when used as an inert ingredient (fragrance
components) in pesticide formulations applied to food contact surfaces
in public eating places, dairy processing equipment, and food
processing equipment and utensils with end-use concentration not to
exceed 100 ppm.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 10, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.940, amend the table in paragraph (a) by revising the
heading and adding in alphabetical order the inert ingredients
``[delta]-decalactone'', ``[gamma]-decalactone'', ``dimethyl-1-
octanol'', ``3,7, ethyl acetate'', ``ethyl butyrate'', ``ethyl
decanoate''; ``ethyl heptanoate'', ``ethyl hexanoate'', ``ethyl
isobutyrate'', ``ethyl laurate'', ``ethyl octanoate'', ``ethyl
nonanoate'', ``[gamma]-heptalactone'', ``[gamma]-hexalactone'', ``cis-
3-hexenyl butyrate'', ``cis-3-hexenyl hexanoate'', ``3-hexenyl 2-
methylbutanoate'', ``hexyl butyrate'', ``hexyl hexanoate'', ``hexyl
isobutyrate'', ``hexyl propionate'', ``hydroxynonanoic acid, [delta]-
lactone'', ``5-hydroxyundecanoic acid lactone'', ``isoamyl acetate'',
``isoamyl alcohol'', ``isoamyl butyrate'', ``isobutyl acetate'',
``isobutyl isobutyrate'', ``isopropyl 2-methylbutyrate'', ``Lavandin
oil (Lavandula hybrida)'', ``linalool'', ``linalyl acetate'',
``[gamma]-nonalactone'', ``[gamma]-octalactone'', ``[omega]-
pentadecalactone'', ``Petitgrain bigarade oil'', ``[alpha]-terpineol'',
``terpinyl acetate (isomer mixture)'', ``Tetrahydrolinalool'',
``[gamma]-undecalactone'', and ``10-undecen-1-yl acetate'' to read as
follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
[delta]-decalactone.......... 705-86-2 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
[gamma]-decalactone.......... 706-14-9 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
[[Page 72530]]
* * * * * * *
3,7-dimethyl-1-octanol....... 106-21-8 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
ethyl acetate................ 141-78-6 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
ethyl butyrate............... 105-54-4 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
ethyl decanoate.............. 110-38-3 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
ethyl heptanoate............. 106-30-9 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
ethyl hexanoate.............. 123-66-0 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
ethyl isobutyrate............ 97-62-1 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
ethyl laurate................ 106-33-2 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
ethyl nonanoate.............. 123-29-5 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
ethyl octanoate.............. 106-32-1 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
[gamma]-heptalactone......... 105-21-5 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
[gamma]-hexalactone.......... 695-06-7 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
cis-3-hexenyl butyrate....... 16491-36-4 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
cis-3-hexenyl hexanoate...... 31501-11-8 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
3-hexenyl 2-methylbutanoate.. 10094-41-4 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
hexyl butyrate............... 2639-63-6 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
hexyl hexanoate.............. 6378-65-0 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
hexyl isobutyrate............ 2349-07-7 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
hexyl propionate............. 2445-76-3 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
hydroxynonanoic acid, [delta]- 3301-94-8 When ready for use, the
lactone. end-use concentration is
not to exceed 100 ppm.
* * * * * * *
5-hydroxyundecanoic acid 710-04-3 When ready for use, the
lactone. end-use concentration is
not to exceed 100 ppm.
* * * * * * *
isoamyl acetate.............. 123-92-2 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
isoamyl alcohol.............. 123-51-3 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
isoamyl butyrate............. 106-27-4 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
isobutyl acetate............. 110-19-0 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
isobutyl isobutyrate......... 97-85-8 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
isopropyl 2-methylbutyrate... 66576-71-4 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Lavandin oil (Lavandula 8022-15-9 When ready for use, the
hybrida). end-use concentration is
not to exceed 100 ppm.
* * * * * * *
linalool..................... 78-70-6 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
linalyl acetate.............. 115-95-7 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
[gamma]-nonalactone.......... 104-61-0 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
[gamma]-octalactone.......... 104-50-7 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
[omega]-pentadecalactone..... 106-02-5 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Petitgrain bigarade oil...... 8014-17-3 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
[alpha]-terpineol............ 98-55-5 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
terpinyl acetate (isomer 8007-35-0 When ready for use, the
mixture). end-use concentration is
not to exceed 100 ppm.
* * * * * * *
tetrahydrolinalool........... 78-69-3 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
[gamma]-undecalactone........ 104-67-6 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
[[Page 72531]]
* * * * * * *
10-undecen-1-yl acetate...... 112-19-6 When ready for use, the
end-use concentration is
not to exceed 100 ppm.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2021-27580 Filed 12-21-21; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 22, 2021.
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.