Rule2024-27450
Various Fragrance Components in Pesticide Formulations; Tolerance Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 25, 2024
Effective
November 25, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of various fragrance components listed in Unit II of this document when they used as inert ingredients in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils when the end-use concentration does not exceed 33 parts per million (ppm). Innovative Reform Group, on behalf of The Clorox Company, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of various fragrance components, when used in accordance with the terms of those exemptions.
Full Text
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<title>Federal Register, Volume 89 Issue 227 (Monday, November 25, 2024)</title>
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[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Rules and Regulations]
[Pages 92821-92830]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27450]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0308; FRL-12327-01-OCSPP]
Various Fragrance Components in Pesticide Formulations; Tolerance
Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of various fragrance components listed in
Unit II of this document when they used as inert ingredients in
antimicrobial formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils when the end-use concentration does not exceed
33 parts per million (ppm). Innovative Reform Group, on behalf of The
Clorox Company, submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of various fragrance components, when used in accordance with
the terms of those exemptions.
DATES: This regulation is effective November 25, 2024. Objections and
requests for hearings must be received on or before January 24, 2025
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-2021-0308, 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. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division
(7505T), 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#02504644504c6d766b616771426772632c656d74"><span class="__cf_email__" data-cfemail="7f2d3b392d31100b161c1a0c3f1a0f1e51181009">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0308 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
January 24, 2025.
EPA's Office of Administrative Law Judges (OALJ), where the Hearing
Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Service and
Filing'', dated
[[Page 92822]]
June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm</a>.
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-2021-0308, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets#express">https://www.epa.gov/dockets/where-send-comments-epa-dockets#express</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of June 1, 2021 (86 FR 29229) (FRL-10023-
95), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11401) by
Innovative Reform Group, on behalf of The Clorox Company, 4900 Johnson
Dr., Pleasanton, CA 94588. The petition requested that 40 CFR be
amended by establishing an exemption from the requirement of a
tolerance for residues of: (1-Methyl-2-(1,2,2-
trimethylbicyclo[3.1.0]hex-3-ylmethyl)cyclopropyl)me thanol (CAS Reg.
No. 198404-98-7); 1,4-Cineole (CAS Reg. No. 470-67-7); 1-Octen-3-ol
(CAS Reg. No. 3391-86-4); 1-p-Menthene-8-thiol (CAS Reg. No. 71159-90-
5); 2,3-Hexanedione (CAS Reg. No. 3848-24-6); 2,5-Dimethylpyrazine (CAS
Reg. No. 123-32-0); 2,6-Dimethyl-4-heptanonem (CAS Reg. No. 108-83-8);
2,6-Dimethylpyrazine (CAS Reg. No.108-50-9); 2-Ethyl-1-hexanol (CAS
Reg. No.104-76-7); 2-Ethyl-3-methylpyrazine (CAS Reg. No. 15707-23-0);
2-Heptanone (CAS Reg. No. 110-43-0); 2-Isobutyl-3-methoxypyrazine (CAS
Reg. No. 24683-00-9); 2-Isopropyl-4-methylthiazole (CAS Reg. No. 15679-
13-7); 2-Methoxy-3-(1-methylpropyl)pyrazine (CAS Reg. No. 24168-70-5);
2-Methyl-4-propyl-1,3-oxathiane (CAS Reg. No. 67715-80-4); 2-
Methylpyrazine (CAS Reg. No. 109-08-0); 2-Nonanone (CAS Reg. No. 821-
55-6); 2-Octanone (CAS Reg. No. 111-13-7); 2-sec-Butylcyclohexanone
(CAS Reg. No. 14765-30-1); 2-Tridecanone (CAS Reg. No. 593-08-8); 2-
Undecanone (CAS Reg. No. 112-12-9); 3,4-Dimethyl-1,2-cyclopentadione
(CAS Reg. No. 13494-06-9); 3-Heptanone (CAS Reg. No. 106-35-4); 3-
Methyl-1-cyclopentadecanone (CAS Reg. No. 541-91-3); 3-Methyl-2-(2-
pentenyl)-2-cyclopenten-1-one, (Z)-(CAS Reg. No. 488-10-8); 3-Methyl-2-
(2E)-2-penten-1-yl-2-cyclopenten-1-one (CAS Reg. No. 6261-18-3); 3-
Methyl-2-(n-pentanyl)-2-cyclopenten-1-one (CAS Reg. No. 1128-08-1); 3-
Methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-2-ol (CAS Reg.
No. 67801-20-1); 3-Octanone (CAS Reg. No. 106-68-3); 4-Acetyl-6-t-
butyl-1,1-dimethylindan (CAS Reg. No. 13171-00-1); 4-Hydroxy-2,5-
dimethyl-3(2H)-furanone (CAS Reg. No. 3658-77-3); 5-Methyl-2-
thiophenecarboxyaldehyde (CAS Reg. No. 13679-70-4); 5-Methyl-2-phenyl-
2-hexenal (CAS Reg. No. 21834-92-4); 6,10-Dimethyl-5,9-undecadien-2-one
(CAS Reg. No. 689-67-8); 6-Methyl-3,5-heptadien-2-one (CAS Reg. No.
1604-28-0); 6-Methyl-5-hepten-2-one (CAS Reg. No. 110-93-0); 8-Decen-5-
olide (CAS Reg. No. 32764-98-0); Acetoin (CAS Reg. No. 513-86-0); Allyl
cinnamate (CAS Reg. No. 1866-31-5); Allyl heptanoate (CAS Reg. No. 142-
19-8); Allyl hexanoate (CAS Reg. No. 123-68-2); Allyl propionate (CAS
Reg. No. 2408-20-0); alpha-Amylcinnamaldehyde (CAS Reg. No. 122-40-7);
[alpha]-Butylcinnamaldehyde (CAS Reg. No. 7492-44-6); [alpha]-
Hexylcinnamaldehyde (CAS Reg. No. 101-86-0); [alpha]-Isobutylphenethyl
alcohol (CAS Reg. No. 7779-78-4); Cajeput oil (Melaleuca leucadendron
L.) (CAS Reg. No. 8008-98-8); Cardamom (Elettaria cardamomum (L.)
Maton) (CAS Reg. No. 85940-32-5); Cardamom seed oil (Elettaria
cardamomum (L.) Maton) (CAS Reg. No. 8000-66-6); d,l-Isomenthone (CAS
Reg. No. 491-07-6); d-Camphor (CAS Reg. No. 464-49-3); d-Fenchone (CAS
Reg. No. 4695-62-9); dl-Camphor (CAS Reg. No. 21368-68-3); Ethyl maltol
(CAS Reg. No. 4940-11-8); Ethyl vanillin (CAS Reg. No. 121-32-4);
Eucalyptol (CAS Reg. No. 470-82-6); Eucalyptus oil (Eucalyptus globulus
Labill) (CAS Reg. No. 8000-48-4); Isoamyl phenethyl ether (CAS Reg. No.
56011-02-0); Isojasmone (CAS Reg. No. 11050-62-7); Linalool oxide (CAS
Reg. No. 60047-17-8); (Z)-Linalool oxide (CAS Reg. No. 5989-33-3); (E)-
Linalool oxide (CAS Reg. No. 34995-77-2); Maltol (CAS Reg. No. 118-71-
8); Maltyl isobutyrate (CAS Reg. No. 65416-14-0); Menthone (CAS Reg.
No. 10458-14-7); Methyl dihydrojasmonate (CAS Reg. No. 24851-98-7);
Methyl phenethyl ether (CAS Reg. No. 3558-60-9); Methyl
cyclopentenolone (CAS Reg. No. 80-71-7); Nerol oxide (CAS Reg. No.
1786-08-9); Nootkatone (CAS Reg. No. 4674-50-4); Origanum oil (CAS Reg.
No. 8007-11-2); Piperonal (CAS Reg. No. 120-57-0); Piperonyl acetate
(CAS Reg. No. 326-61-4); p-Mentha-8-thiol-3-one (CAS Reg. No. 38462-22-
5); Rosemary oil (Rosemarinus officinalis L.) (CAS Reg. No. 8000-25-7);
Rue oil (Ruta graveolens L.) (CAS Reg. No. 8014-29-7); Sage oil,
Spanish (Salvia lavandulaefolia Vahl.) (CAS Reg. No. 8022-56-8);
Tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran (CAS Reg. No. 16409-
43-1); Theaspirane (CAS Reg. No. 36431-72-8); 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 with end-use concentrations
not to exceed 33 ppm. That document referenced a summary of the
petition prepared by Innovative Reform Group on behalf of The Clorox
Company, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
There were no comments received in response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and
[[Page 92823]]
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(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. When making a safety determination for an
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B)
directs EPA to consider the considerations in section 408(b)(2)(C) and
(D). Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' Section 408(b)(2)(D) lists other factors for EPA consideration
making safety determinations, e.g., the validity, completeness, and
reliability of available data, nature of toxic effects, available
information concerning the cumulative effects of the pesticide chemical
and other substances with a common mechanism of toxicity, and available
information concerning aggregate exposure levels to the pesticide
chemical and other related substances, among others.
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the various fragrance
components identified in Unit II of this document, including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with these various
fragrance components follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by various fragrance components
identified in Unit II, as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies are discussed in this unit.
The Agency assessed these fragrance components via the Threshold of
Toxicological Concern (TTC) approach as outlined by the European Food
Safety Authority (EFSA) in their 2019 guidance document on the use of
TTC in food safety assessment. Information regarding the database of
studies and chemicals used to derive TTCs are reviewed therein. The TTC
approach has been used by the Joint Expert Committee on Food Additives
of the United Nations' (U.N.) Food and Agriculture Organization and the
World Health Organization (JECFA), the former Scientific Committee on
Food of the European Commission, the European Medicines Agency, and
EFSA.
Information from JECFA reports as well as predictive toxicology
using the Organisation for Economic Co-operation and Development (OECD)
Quantitative Structure-Activity Relationships (QSAR) Toolbox was used
to confirm that the fragrances listed in Unit II have low carcinogenic
potential and are thus good candidates for the application of the TTC
method. Although 24 chemicals had in silico carcinogenicity alerts,
JECFA concluded and EPA concurs that all fragrances listed in Unit II
have low carcinogenic potential, based on in vitro and/or in vivo
genotoxicity studies available on the chemical or structurally related
chemicals. Therefore, the TTC method can be applied to these
fragrances.
TTCs are derived from a conservative and rigorous approach to
establish generic threshold values for human exposure at which a very
low probability of adverse effects is likely. By comparing a range of
compounds by Cramer Class (classes I, II, and III which correspond to
the probability of low, moderate, and high toxicity) and NOEL (no-
observed-effect-level), fifth percentile NOELs were established for
each Cramer Class as ``Human Exposure Thresholds''. These values were
3, 0.91 and 0.15 mg/kg/day for classes I, II, and III, respectively.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk
[[Page 92824]]
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. All of the fragrance
components listed in Unit II are in Cramer Class II, which is defined
as chemicals of simple structure and efficient modes of metabolism,
suggesting low oral toxicity. Therefore, the NOEL of 0.91 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. In evaluating dietary
exposure to each of the fragrance components listed in Unit II (e.g.
ingesting foods that come in contact with surfaces treated with
pesticide formulations containing these fragrance components,and
drinking water exposures), EPA considered exposure under the proposed
exemptions at a concentration not to exceed 33 ppm for each of the
listed fragrance components as well as any other sources of dietary
exposure. EPA assessed dietary exposures from the fragrance components
listed in Unit II in food as follows:
The dietary assessment for food contact sanitizer solutions
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake
(EDI). The assessment considered application rates, residual solution
or quantity of solution remaining on the treated surface without
rinsing with potable water, surface area of the treated surface which
comes into contact with food, pesticide migration fraction, and body
weight. These assumptions are based on U.S. Food and Drug
Administration guidelines.
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
The fragrance components listed in Unit II may be used as inert
ingredients in products that are registered for specific uses that may
result in residential exposure, such as pesticides used in and around
the home. The Agency conducted a conservative assessment of potential
residential exposure by assessing various fragrance components in
disinfectant-type uses (indoor scenarios). The Agency's assessment of
adult residential exposure combines high-end dermal and inhalation
handler exposure from indoor hard surface, wiping, and aerosol spray
uses. The Agency's assessment of children's residential exposure
includes total post-application exposures associated with contact with
treated indoor surfaces (dermal and hand-to-mouth exposures).
3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found the fragrance components listed in Unit II to
share a common mechanism of toxicity with any other substances, nor do
they appear to produce a toxic metabolite produced by other substances.
For the purposes of the tolerance exemptions established in this rule,
therefore, EPA has assumed that the fragrance components listed in Unit
II do not have common mechanisms of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor. The FQPA SF has been reduced to 1X in this risk
assessment because clear NOELs and LOELs were established in the
studies used to derive the endpoints (which included developmental and
reproductive toxicity studies), maternal and developmental-specific 5th
percentile NOELs indicate low potential for offspring susceptibility,
and the conservative assumptions made in the exposure assessment are
unlikely to underestimate risk.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute aggregate risk. An acute aggregate risk assessment takes
into account acute exposure estimates from dietary consumption of food
and drinking water. No adverse effects resulting from a single oral
exposure were identified and no acute dietary endpoint was selected for
any of the fragrance components listed in Unit II. Therefore, these
fragrance components are not expected to pose an acute risk.
2. Short-term aggregate risk. Short-term aggregate exposure takes
into account short-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level). For
residential handler short-term exposure scenarios, MOEs ranged from
13,000 to 230,000, while for residential post-application exposure
scenarios, MOEs ranged from 15,000 to 32,000. These MOEs are greater
than the level of concern (LOC) of 100 and therefore are not of
concern. The short-term aggregate MOE is 455 for adults and 168 for
children, which are greater than the LOC of 100 and therefore are not
of concern.
3. Intermediate-term aggregate risk. Intermediate-term aggregate
exposure takes into account intermediate-term residential (dermal and
inhalation) exposure plus chronic dietary exposure (food and drinking
water). As the same endpoints were selected for short-term and
intermediate-term exposures, intermediate-term aggregate risk is equal
to the short-term aggregate risk, and it is not of concern.
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 21% of the cPAD for the U.S. population and
[[Page 92825]]
58% of the cPAD for children 1 to 2 years old, the population group
receiving the greatest exposure. Chronic residential exposure to
residues of these fragrance components is not expected. Therefore, the
chronic aggregate risk is equal to the chronic dietary exposure for
children 1 to 2 years old (58% of the cPAD).
5. Aggregate cancer risk for U.S. population. There is low concern
for genotoxicity/carcinogenicity in humans for the fragrance components
listed in Unit II of this document. Therefore, the assessment under the
TTC value for non-cancer risks is protective for all risks, including
carcinogenicity.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to residues of the fragrance components listed in Unit II.
V. Other Considerations
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 fragrance components listed in Unit II of this document in or on
any food commodities. EPA is, however, establishing limitations on the
amount of these fragrance components that may be used in antimicrobial
pesticide formulations. These limitations will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA
will not register any pesticide formulation for food use that contains
these fragrance components in excess of 33 ppm in the final pesticide
formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of various fragrance components listed in Unit
II of this document 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 and utensils with an end-use concentration not to
exceed 33 ppm under 40 CFR 180.940(a).
VII. Statutory and Executive Order Reviews
This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 18, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.940 is amended by adding in alphabetical order the
following inert ingredients to table 1 to paragraph (a):
a. Acetoin
b. 4-acetyl-6-t-butyl-1,1-dimethylindan
c. Allyl cinnamate
d. Allyl heptanoate
e. Allyl hexanoate
f. Allyl propionate
g. 1,3-Benzodioxole-5-carboxaldehyde
h. Bicyclo[2.2.1]heptan-2-one, 1,7,7-trimethyl-, (1R, 4R)-
i. [alpha]-Butylcinnamaldehyde
j. 2-sec-Butylcyclohexanone
k. Cajeput oil (Melaleuca leucadendron L.)
l. Camphor
m. Cardamom (Elettaria cardamomum (L.) Maton)
n. Cardamom seed oil (Elettaria cardamomum (L.) Maton)
o. Cyclopentaneacetai acid, 3-oxo-2-pentyl-, methyl ester
p. Cyclopropanemethanol, 1-methyl-2-[(1,2,2-trimethylbicyclo[3.1.0]hex-
3-yl)methyl]-
q. Diisobutyl ketone
r. 3,4-Dimethyl-1,2-cyclopentadione
[[Page 92826]]
s. 2,5-Dimethylpyrazine
t. 2,6-Dimethylpyrazine
u. 6,10-Dimethylundeca-5,9-dien-2-one
v. Ethyl amyl ketone
w. Ethyl maltol
x. 2-Ethyl-3-methylpyrazine
y. Ethylvanillin
z. Eucalyptus oil
aa. Fenchone
bb. Heptanal, 2-(phenlymethylene)-
cc. 3-Heptanone
dd. 2,3-Hexanedione
ee. 1-Hexanol, 2-ethyl-
ff. [alpha]-Hexylcinnamaldehyde
gg. 4-Hydroxy-2,5-dimethyl-3(2H)-furanone
hh. 2-Isobutyl-3-methoxypyrazine
ii. [alpha]-Isobutylphenethyl alcohol
jj. Isojasmone
kk. d,l-Isomenthone
ll. 2-Isopropyl-4-methylthiazole
mm. Linalool oxide
nn. (E)-Linalool oxide
oo. (Z)-Linalool oxide
pp. Maltyl isobutyrate
qq. p-Mentha-8-thiol-3-one
rr. p-Menthan-3-one
ss. p-Menthane, 1,8-epoxy-
tt. 1-p-Menthene-8-thiol
uu. 2-Methoxy-3-(1-methylpropyl)pyrazine
vv. Methyl n-amyl ketone
ww. 3-Methyl-1-cyclopentadecanone
xx. Methylcyclopentenolone
yy. 6-Methyl-3,5-heptadien-2-one
zz. 6-Methyl-5-hepten-2-one
aaa. 3-Methyl-2-(n-pentanyl)-2-cyclopenten-1-one
bbb. 3-Methyl-2-(2E)-2-penten-1-yl-2-cyclopenten-1-one
ccc. 3-Methyl-2-(2-pentenyl)-2-cyclopenten-1-one, (Z)-
ddd. Methyl phenethyl ether
eee. 5-Methyl-2-phenyl-2-hexenal
fff. 2-Methyl-4-propyl-1,3-oxathiane
ggg. 5-Methyl-2-thiophenecarboxyaldehyde
hhh. 3-Methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol
iii. 2-Methylpyrazine
jjj. Nerol oxide
kkk. 2-Nonanone
lll. Nootkatone
mmm. 2-Octanone
nnn. 1-Octen-3-ol
ooo. Oils, rosemary
ppp. Oils, sage
qqq. Origanum oil, Spanish
rrr. 7-Oxabicyclo(2.2.1.)heptane, 1-methyl-4-(1-methylethyl)-
sss. Phenylethyl isoamyl ether
ttt. Piperonyl acetate
uuu. 4H-Pyran-4-one, 3-hydroxy-2-methyl-
vvv. Rue oil (Ruta graveolens L.)
www. Tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran
xxx. Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one
yyy. Theaspirane
zzz. 2-Tridecanone
aaaa. 2-Undecanone
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
------------------------------------------------------------------------
* * * * * * *
Acetoin...................... 513-86-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
4-acetyl-6-t-butyl-1,1- 13171-00-1 When ready for use,
dimethylindan. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Allyl cinnamate.............. 1866-31-5 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
Allyl heptanoate............. 142-19-8 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
Allyl hexanoate.............. 123-68-2 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
Allyl propionate............. 2408-20-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
1,3-Benzodioxole-5- 120-57-0 When ready for use,
carboxaldehyde. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Bicyclo[2.2.1]heptan-2-one, 464-49-3 When ready for use,
1,7,7-trimethyl-, (1R, 4R)-. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
[alpha]-Butylcinnamaldehyde.. 7492-44-6 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
2-sec-Butylcyclohexanone..... 14765-30-1 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Cajeput oil (Melaleuca 8008-98-8 When ready for use,
leucadendron L.). the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Camphor...................... 21368-68-3 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
[[Page 92827]]
* * * * * * *
Cardamom (Elettaria 85940-32-5 When ready for use,
cardamomum (L.) Maton). the end-use
concentration is
not to exceed 33
ppm.
Cardamom seed oil (Elettaria 8000-66-6 When ready for use,
cardamomum (L.) Maton). the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Cyclopentaneacetai acid, 3- 24851-98-7 When ready for use,
oxo-2-pentyl-, methyl ester. the end-use
concentration is
not to exceed 33
ppm.
Cyclopropanemethanol, 1- 198404-98-7 When ready for use,
methyl-2-[(1,2,2- the end-use
trimethylbicyclo[3.1.0]hex-3- concentration is
yl)methyl]-. not to exceed 33
ppm.
* * * * * * *
Diisobutyl ketone............ 108-83-8 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
3,4-Dimethyl-1,2- 13494-06-9 When ready for use,
cyclopentadione. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2,5-Dimethylpyrazine......... 123-32-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
2,6-Dimethylpyrazine......... 108-50-9 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
6,10-Dimethylundeca-5,9-dien- 689-67-8 When ready for use,
2-one. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Ethyl amyl ketone............ 106-68-3 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Ethyl maltol................. 4940-11-8 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Ethyl-3-methylpyrazine..... 15707-23-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Ethylvanillin................ 121-32-4 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
Eucalyptus oil............... 8000-48-4 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Fenchone..................... 4695-62-9 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Heptanal, 2-(phenlymethylene)- 122-40-7 When ready for use,
. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
3-Heptanone.................. 106-35-4 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2,3-Hexanedione.............. 3848-24-6 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
1-Hexanol, 2-ethyl-.......... 104-76-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
[alpha]-Hexylcinnamaldehyde.. 101-86-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
[[Page 92828]]
* * * * * * *
4-Hydroxy-2,5-dimethyl-3(2H)- 3658-77-3 When ready for use,
furanone. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Isobutyl-3-methoxypyrazine. 24683-00-9 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
[alpha]-Isobutylphenethyl 7779-78-4 When ready for use,
alcohol. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Isojasmone................... 11050-62-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
d,l-Isomenthone.............. 491-07-6 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Isopropyl-4-methylthiazole. 15679-13-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Linalool oxide............... 60047-17-8 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
(E)-Linalool oxide........... 34995-77-2 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
(Z)-Linalool oxide........... 5989-33-3 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Maltyl isobutyrate........... 65416-14-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
p-Mentha-8-thiol-3-one....... 38462-22-5 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
p-Menthan-3-one.............. 10458-14-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
p-Menthane, 1,8-epoxy-....... 470-82-6 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
1-p-Menthene-8-thiol......... 71159-90-5 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Methoxy-3-(1- 24168-70-5 When ready for use,
methylpropyl)pyrazine. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Methyl n-amyl ketone......... 110-43-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
3-Methyl-1-cyclopentadecanone 541-91-3 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
Methylcyclopentenolone....... 80-71-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
6-Methyl-3,5-heptadien-2-one. 1604-28-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
6-Methyl-5-hepten-2-one...... 110-93-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
3-Methyl-2-(n-pentanyl)-2- 1128-08-1 When ready for use,
cyclopenten-1-one. the end-use
concentration is
not to exceed 33
ppm.
3-Methyl-2-(2E)-2-penten-1-yl- 6261-18-3 When ready for use,
2-cyclopenten-1-one. the end-use
concentration is
not to exceed 33
ppm.
[[Page 92829]]
3-Methyl-2-(2-pentenyl)-2- 488-10-8 When ready for use,
cyclopenten-1-one, (Z)-. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Methyl phenethyl ether....... 3558-60-9 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
5-Methyl-2-phenyl-2-hexenal.. 21834-92-4 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Methyl-4-propyl-1,3- 67715-80-4 When ready for use,
oxathiane. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
5-Methyl-2- 13679-70-4 When ready for use,
thiophenecarboxyaldehyde. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
3-Methyl-5-(2,2,3-trimethyl-3- 67801-20-1 When ready for use,
cyclopenten-1-yl)pent-4-en-2- the end-use
ol. concentration is
not to exceed 33
ppm.
* * * * * * *
2-Methylpyrazine............. 109-08-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Nerol oxide.................. 1786-08-9 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Nonanone................... 821-55-6 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Nootkatone................... 4674-50-4 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Octanone................... 111-13-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
1-Octen-3-ol................. 3391-86-4 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Oils, rosemary............... 8000-25-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
Oils, sage................... 8022-56-8 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Origanum oil, Spanish........ 8007-11-2 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
7-Oxabicyclo(2.2.1.)heptane, 470-67-7 When ready for use,
1-methyl-4-(1-methylethyl)-. the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Phenylethyl isoamyl ether.... 56011-02-0 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Piperonyl acetate............ 326-61-4 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
4H-Pyran-4-one, 3-hydroxy-2- 118-71-8 When ready for use,
methyl-. the end-use
concentration is
not to exceed 33
ppm.
[[Page 92830]]
* * * * * * *
Rue oil (Ruta graveolens L.). 8014-29-7 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
Tetrahydro-4-methyl-2-(2- 16409-43-1 When ready for use,
methylpropen-1-yl)pyran. the end-use
concentration is
not to exceed 33
ppm.
Tetrahydro-6-(3-pentenyl)-2H- 32764-98-0 When ready for use,
pyran-2-one. the end-use
concentration is
not to exceed 33
ppm.
Theaspirane.................. 36431-72-8 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Tridecanone................ 593-08-8 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
2-Undecanone................. 112-12-9 When ready for use,
the end-use
concentration is
not to exceed 33
ppm.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-27450 Filed 11-22-24; 8:45 am]
BILLING CODE 6560-50-P
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