Various Fragrance Components; Exemptions From the Requirement of a Tolerance

CourtEnvironmental Protection Agency
Citation86 FR 72525
Record Number2021-27580
Publication Date22 December 2021
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(iv) Exempt records from other
systems. In addition, in the course of
carrying out the overall purpose for this
system, exempt records from other
system of records may in turn become
part of the records maintained in this
system. To the extent that copies of
exempt records from those other
systems of records are maintained in
this system, the DoD claims the same
exemptions for the records from those
other systems that are entered into this
system, as claimed for the prior
system(s) of which they are a part,
provided the reason for the exemption
remains valid and necessary.
* * * * *
Dated: December 16, 2021.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2021–27706 Filed 12–21–21; 8:45 am]
BILLING CODE 5001–06–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0294; FRL–9226–01–
OCSPP]
Various Fragrance Components;
Exemptions From the Requirement of
a Tolerance
AGENCY
: Environmental Protection
Agency (EPA).
ACTION
: Final rule.
SUMMARY
: This regulation establishes
exemptions from the requirement of a
tolerance for residues of various
fragrance components listed in unit II of
this document when they are used as
inert ingredients in antimicrobial
pesticide formulations for use on food
contact surfaces in public eating places,
dairy processing equipment, and food
processing equipment and utensils with
end-use concentration not to exceed 100
parts per million (ppm). Verto Solutions
on behalf of The Clorox Company
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the establishment
of such exemptions from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of various fragrance
components.
DATES
: This regulation is effective
December 22, 2021. Objections and
requests for hearings must be received
on or before February 22, 2022, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION
).
ADDRESSES
: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0294, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT
:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION
:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
Animal production (NAICS code
112).
Food manufacturing (NAICS code
311).
Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2020–0294 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
February 22, 2022. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2020–0294, by one of the following
methods:
Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of June 24,
2020 (85 FR 37807) (FRL–10010–82),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–11016) by Verto
Solutions on behalf of The Clorox
Company, 4900 Johnson Dr., Pleasanton,
CA 94588. The petition requested that
40 CFR 180.940(a) be amended by
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establishing an exemption from the
requirement of a tolerance for residues
of d-decalactone (CAS Reg. No. 705–86–
2), g-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), g-heptalactone (CAS Reg.
No. 105–21–5), g-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, d-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), g-nonalactone
(CAS Reg. No. 104–61–0), g-octalactone
(CAS Reg. No. 104–50–7), w-
pentadecalactone (CAS Reg. No. 106–
02–5), Petitgrain bigarade oil (CAS Reg.
No. 8014–17–3), a-terpineol (CAS Reg.
No. 98–55–5), terpinyl acetate (isomer
mixture) (CAS Reg. No. 8007–35–0),
Tetrahydrolinalool (CAS Reg. No. 78–
69–3), g-undecalactone (CAS Reg. No.
104–67–6), 10-undecen-1-yl acetate
(CAS Reg. No. 112–19–6) when used as
an inert ingredient fragrance component
in pesticide formulations applied to
food contact surfaces in public eating
places, dairy processing equipment, and
food processing equipment with end-
use concentrations not to exceed 100
ppm. That document referenced a
summary of the petition prepared by
Verto Solutions on behalf of The Clorox
Company, the petitioner, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for various fragrance
components including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with various fragrance
components follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by various fragrance components as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
The Agency assessed these fragrance
components via the Threshold of
toxicological concern (TTC) approach as
outlined by the European Food Safety
Authority (EFSA) in their 2018
proposed guidance document on the use
of TTC in food safety assessment. This
approach relies on the most recent
evaluation of the literature on TTC as
reviewed by EFSA and the World
Health Organization (WHO) in 2016.
Information regarding the database of
studies and chemicals used to derive
TTCs are reviewed therein. The TTC
approach has been used by the Joint
Expert Committee on Food Additives of
the United Nation’s Food and
Agriculture Organization and the World
Health Organization, the former
Scientific Committee on Food of the
European Commission, the European
Medicines Agency, and EFSA.
Thresholds of toxicological concern
(TTC) are derived from a conservative
and rigorous approach developed by
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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 mg/kg/day for Cramer Class I, II,
and III, respectively.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
The human exposure threshold value
for threshold (i.e., non-cancer) risks is
based upon Cramer structural class. In
the case of the fragrance components
listed above, all the substances included
are in the Cramer Class I category,
which is defined as chemicals of simple
structure and efficient modes of
metabolism, suggesting low oral
toxicity. The corresponding TTC value
for substances in the Cramer Class I
category is 30 mg/kg/day, which is based
on a 5th percentile NOEL of 3 mg/kg/
day.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to each of the fragrance
components listed in Unit II, EPA
considered exposure under the
proposed tolerance exemptions at a
concentration not to exceed 100 ppm for
each of the fragrance components listed
in Unit II. as well as any other sources
of dietary exposure. EPA assessed
dietary exposures from various
fragrance components in food as
follows:
The dietary assessment for food
contact sanitizer solutions calculated
the Daily Dietary Dose (DDD) and the
Estimated Daily Intake (EDI). The
assessment considered: Application
rates, residual solution or quantity of
solution remaining on the treated
surface without rinsing with potable
water, surface area of the treated surface
which comes into contact with food,
pesticide migration fraction, and body
weight. These assumptions are based on
Food and Drug Administration (FDA)
guidelines.
The dietary assessment for food
contact sanitizer solutions showed that
children 1 to 2 years old would be the
highest exposed subgroup (48% of the
chronic PAD (cPAD)). The general U.S.
population resulted in 19% of the
cPAD. Any percent cPAD exceeding
100% would be of concern.
2. Dietary exposure from drinking
water. For the purpose of the screening
level dietary risk assessment to support
this request for an exemption from the
requirement of a tolerance for various
fragrance components a conservative
drinking water concentration value of
100 ppb based on screening level
modeling was used to assess the
contribution to drinking water for the
chronic dietary risk assessments for
parent compound. These values were
directly entered into the dietary
exposure model.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to non-
occupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Various fragrance components may be
used as inert ingredients in products
that are registered for specific uses that
may result in residential exposure, such
as pesticides used in and around the
home. The Agency conducted a
conservative assessment of potential
residential exposure by assessing
various fragrance components in
pesticide in disinfectant-type uses
(indoor scenarios). The Agency’s
assessment of adult residential exposure
combines high-end dermal and
inhalation handler exposure from
indoor hard surface, wiping and aerosol
spray. The Agency’s assessment of
children’s residential exposure includes
total post-application exposures
associated with total exposures
associated with contact with treated
indoor surfaces (dermal and hand-to-
mouth exposures.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’ EPA has not
made a common mechanism of toxicity
finding as to these fragrance chemicals
listed in unit II and any other
substances, and these fragrance
chemicals do not appear to produce
toxic metabolites produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has not
assumed that these fragrance chemicals
listed in unit II have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
FFDCA Section 408(b)(2)(C) provides
that EPA shall retain an additional
tenfold (10X) margin of safety for infants
and children in the case of threshold
effects to account for prenatal and
postnatal toxicity and the completeness
of the database on toxicity and exposure
unless EPA determines based on reliable
data that a different margin of safety
will be safe for infants and children.
This additional margin of safety is
commonly referred to as the Food
Quality Protection Act (FQPA) safety
factor (SF). In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor. The FQPA SF has been reduced
to 1X in this risk assessment because
clear NOELs and LOELs were
established in the studies analyzed by
Munro et al. 1996 (which included
developmental and reproductive
toxicity studies), maternal and
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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 d-
decalactone (CAS Reg. No. 705–86–2), g-
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), g-heptalactone (CAS Reg. No.
105–21–5), g-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, d-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–
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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), g-nonalactone
(CAS Reg. No. 104–61–0), g-octalactone
(CAS Reg. No. 104–50–7), w-
pentadecalactone (CAS Reg. No. 106–
02–5), Petitgrain bigarade oil (CAS Reg.
No. 8014–17–3), a-terpineol (CAS Reg.
No. 98–55–5), terpinyl acetate (isomer
mixture) (CAS Reg. No. 8007–35–0),
Tetrahydrolinalool (CAS Reg. No. 78–
69–3), g-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
1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.940, amend the table in
paragraph (a) by revising the heading
and adding in alphabetical order the
inert ingredients ‘‘d-decalactone’’, ‘‘g-
decalactone’’, ‘‘dimethyl-1-octanol’’,
‘‘3,7, ethyl acetate’’, ‘‘ethyl butyrate’’,
‘‘ethyl decanoate’’; ‘‘ethyl heptanoate’’,
‘‘ethyl hexanoate’’, ‘‘ethyl isobutyrate’’,
‘‘ethyl laurate’’, ‘‘ethyl octanoate’’,
‘‘ethyl nonanoate’’, ‘‘g-heptalactone’’, ‘‘g-
hexalactone’’, ‘‘cis-3-hexenyl butyrate’’,
‘‘cis-3-hexenyl hexanoate’’, ‘‘3-hexenyl
2-methylbutanoate’’, ‘‘hexyl butyrate’’,
‘‘hexyl hexanoate’’, ‘‘hexyl isobutyrate’’,
‘‘hexyl propionate’’, ‘‘hydroxynonanoic
acid, d-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’’, ‘‘g-nonalactone’’, ‘‘g-
octalactone’’, ‘‘w-pentadecalactone’’,
‘‘Petitgrain bigarade oil’’, ‘‘a-terpineol’’,
‘‘terpinyl acetate (isomer mixture)’’,
‘‘Tetrahydrolinalool’’, ‘‘g-
undecalactone’’, and ‘‘10-undecen-1-yl
acetate’’ to read as follows:
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
* * * * *
(a) * * *
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(a)
Pesticide chemical CAS Reg. No. Limits
*******
d-decalactone ..................................................... 705–86–2 When ready for use, the end-use concentration is not to exceed 100 ppm.
g-decalactone ..................................................... 706–14–9 When ready for use, the end-use concentration is not to exceed 100 ppm.
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(a)—Continued
Pesticide chemical CAS Reg. No. Limits
*******
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.
*******
g-heptalactone .................................................... 105–21–5 When ready for use, the end-use concentration is not to exceed 100 ppm.
*******
g-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, d-lactone ........................ 3301–94–8 When ready for use, the end-use concentration is not to exceed 100 ppm.
*******
5-hydroxyundecanoic acid lactone ..................... 710–04–3 When ready for use, the 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 hybrida) ....................... 8022–15–9 When ready for use, the 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.
*******
g-nonalactone ..................................................... 104–61–0 When ready for use, the end-use concentration is not to exceed 100 ppm.
*******
g-octalactone ...................................................... 104–50–7 When ready for use, the end-use concentration is not to exceed 100 ppm.
*******
w-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.
a-terpineol .......................................................... 98–55–5 When ready for use, the end-use concentration is not to exceed 100 ppm.
*******
terpinyl acetate (isomer mixture) ....................... 8007–35–0 When ready for use, the 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.
*******
g-undecalactone ................................................. 104–67–6 When ready for use, the end-use concentration is not to exceed 100 ppm.
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(a)—Continued
Pesticide chemical CAS Reg. No. Limits
*******
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 409, 424, 483, 484, 488,
489, and 498
[CMS–1747–CN and CMS–5531–CN]
RINs 0938–AU37 and 0938–AU32
Medicare and Medicaid Programs; CY
2022 Home Health Prospective
Payment System Rate Update; Home
Health Value-Based Purchasing Model
Requirements and Model Expansion;
Home Health and Other Quality
Reporting Program Requirements;
Home Infusion Therapy Services
Requirements; Survey and
Enforcement Requirements for
Hospice Programs; Medicare Provider
Enrollment Requirements; and COVID–
19 Reporting Requirements for Long-
Term Care Facilities; Correction
AGENCY
: Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION
: Final rule; correction.
SUMMARY
: This document corrects
technical and typographical errors that
appeared in the final rule published in
the Federal Register on November 9,
2021 titled ‘‘Medicare and Medicaid
Programs; CY 2022 Home Health
Prospective Payment System Rate
Update; Home Health Value-Based
Purchasing Model Requirements and
Model Expansion; Home Health and
Other Quality Reporting Program
Requirements; Home Infusion Therapy
Services Requirements; Survey and
Enforcement Requirements for Hospice
Programs; Medicare Provider
Enrollment Requirements; and COVID–
19 Reporting Requirements for Long-
Term Care Facilities’’.
DATES
: This correcting document is
effective January 1, 2022.
FOR FURTHER INFORMATION CONTACT
:
Brian Slater, (410) 786–5229, for home
health payment inquiries.
Frank Whelan (410) 786–1302, for
provider enrollment inquiries.
SUPPLEMENTARY INFORMATION
:
I. Background
In FR Doc. 2021–23993 of November
9, 2021 (86 FR 62431), there were a
number of technical errors that are
identified and corrected in this
correcting document. The provisions in
this correction document are effective as
if they had been included in the
document that appeared in the
November 9, 2021 Federal Register.
II. Summary of Errors
A. Summary of Errors in the Preamble
On page 62240, we inadvertently
included a website address that is not
related to Home Health Value Based
Purchasing Model.
On pages 62250 and 62251, in our
discussion of the functional impairment
levels under the Patient-Driven
Groupings Model (PDGM), we made
typographical errors in an Outcome and
Assessment Information Set (OASIS)
item number.
On page 62251, we inadvertently
omitted a note following the table titled
‘‘Table 2: OASIS Points Table for those
Items Associated with Increases
Resource Use Using a Reduced Set of
OASIS Items, CY 2020’’.
B. Summary of Errors in the Regulations
Text
On page 62419, in our amendatory
instructions for § 424.525, we made an
inadvertent error in specifying the
revisions to § 424.525(a)(3).
III. Waiver of Proposed Rulemaking
and Delay in Effective Date
Under 5 U.S.C. 553(b) of the
Administrative Procedure Act (APA),
the agency is required to publish a
notice of the proposed rulemaking in
the Federal Register before the
provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Act
requires the Secretary to provide for
notice of the proposed rulemaking in
the Federal Register and provide a
period of not less than 60 days for
public comment. In addition, section
553(d) of the APA, and section
1871(e)(1)(B)(i) of the Act mandate a 30-
day delay in effective date after issuance
or publication of a rule. Sections
553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the notice
and comment and delay in effective date
APA requirements; in cases in which
these exceptions apply, sections
1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act provide exceptions from the notice
and 60-day comment period and delay
in effective date requirements of the Act
as well. Section 553(b)(B) of the APA
and section 1871(b)(2)(C) of the Act
authorize an agency to dispense with
normal rulemaking requirements for
good cause if the agency makes a
finding that the notice and comment
process are impracticable, unnecessary,
or contrary to the public interest. In
addition, both section 553(d)(3) of the
APA and section 1871(e)(1)(B)(ii) of the
Act allow the agency to avoid the 30-
day delay in effective date where such
delay is contrary to the public interest
and an agency includes a statement of
support.
We believe that this final rule
correction does not constitute a rule that
would be subject to the notice and
comment or delayed effective date
requirements. This document corrects
typographical and technical errors in
the CY 2022 HH PPS final rule, but does
not make substantive changes to the
policies or payment methodologies that
were adopted in the final rule. As a
result, this final rule correction is
intended to ensure that the information
in the CY 2022 HH PPS final rule
accurately reflects the policies adopted
in that document.
In addition, even if this were a rule to
which the notice and comment
procedures and delayed effective date
requirements applied, we find that there
is good cause to waive such
requirements. Undertaking further
notice and comment procedures to
incorporate the corrections in this
document into the final rule or delaying
the effective date would be contrary to
the public interest because it is in the
public’s interest for providers to receive
appropriate payments in as timely a
manner as possible, and to ensure that
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