Various Fragrance Components in Pesticide Formulations; Exemption From the Requirement for a Tolerance
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 used as an iner...
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 used as an inert ingredient in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils under 40 CFR 180.940(a) when the end-use concentration does not exceed 5 parts per million (ppm). Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Innovative Reform Group, on behalf of The Clorox Company, submitted a petition to EPA requesting 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 17, 2025. Objections and requests for hearings must be received on or before January 16, 2026 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of this document).
ADDRESSES:
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2021-0311, is available online at
https://www.regulations.gov.
Additional information about dockets generally, along with instructions for visiting the docket in-person, is available at
https://www.epa.gov/dockets.
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:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT
.
B. What is EPA's authority for taking this action?
EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(c)(2)(A)(i) 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 exemption is “safe.” FFDCA section 408(c)(2)(A)(ii) 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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require 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. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”
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. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. 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 the docket ID number EPA-HQ-OPP-2021-0311 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 16, 2026.
EPA's Office of Administrative Law Judges (OALJ), in which 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 Filing and Service,” dated
( printed page 51128)
June 22, 2023, which can be found at
https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
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
https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
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 at
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. If you wish to include CBI in your request, please follow the applicable instructions at
https://www.epa.gov/dockets/commenting-epa-dockets#rules
and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.
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-11402) 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 2′-Acetonaphthone (CAS Reg. No. 93-08-3); Allyl phenoxyacetate (CAS Reg. No.7493-74-5); trans-Anethole (CAS Reg. No. 4180-23-8); Benzene, 1-(cyclopropylmethyl)-4-methoxy- (CAS Reg. No. 16510-27-3); Benzothiazole (CAS Reg. No. 95-16-9); 5,7-Dihydro-2-methylthieno(3,4-d)pyrimidine (CAS Reg. No. 36267-71-7); 1,3-Dioxolane-2-acetic acid, 2-methyl-, ethyl ester (CAS Reg. No. 6413-10-1); Diphenyl ether (CAS Reg. No. 101-84-8); Ethyl 2,4-dimethyldioxolane-2-acetate (CAS Reg. No. 6290-17-1); 5-Ethyl-3-hydroxy-4-methyl-2(5H)-furanone (CAS Reg. No. 698-10-2); Ethyl methylphenylglycidate (CAS Reg. No. 77-83-8); Ethyl 3-phenylglycidate (CAS Reg. No. 121-39-1); Ethyl (p-tolyloxy)acetate (CAS Reg. No. 67028-40-4); Fenner oil bitter (Foeniculum vulgare Miller) (CAS Reg. No. 8006-84-6); Isobutyl 3-(2-furan)propionate (CAS Reg. No. 105-01-1); Isoeugenyl benzyl ether (CAS Reg. No. 120-11-6); Isoeugenyl methyl ether (CAS Reg. No. 93-16-3); Isoquinoline (CAS Reg. No. 119-65-3); 1-Methoxy-4-propylbenzene (CAS Reg. No. 104-45-0); 4-Methyl-2-(1-phenylethyl)-1,3-dioxolane (CAS Reg. No. 67634-23-5); 4-(3,4-Methylenedioxyphenyl)-2-butanone (CAS Reg. No. 55418-52-5); 1-Methylnaphthalene (CAS Reg. No. 90-12-0); Naphtho{2,1-b}furan, dodecahydro-3a,6,6,9a-tetramethyl- (CAS Reg. No. 3738-00-9); β-Naphthyl ethyl ether (CAS Reg. No. 93-18-5); β-Naphthyl isobutyl ether (CAS Reg. No. 2173-57-1); β-Naphthyl methyl ether (CAS Reg. No. 93-04-9); Oil of anise (CAS Reg. No. 8007-70-3); Oils, star anise (CAS Reg. No. 68952-43-2); Phenoxy ethyl isobutyrate (CAS Reg. No. 103-60-6); 2-(3-Phenylpropyl)tetrahydrofuran (CAS Reg. No. 3208-40-0); Sclareolide (CAS Reg. No. 564-20-5); Tuberose oil (Polianthes tuberosa L.) (CAS Reg. No. 8024-05-3); when used as an inert ingredient (fragrance components) in antimicrobial formulations (food-contact surface sanitizing solutions) applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils under 40 CFR 180.940(a) with end-use concentrations not to exceed 5 ppm. That document referenced a summary of the petition prepared by Innovative Reform Group on behalf of The Clorox Company, the petitioner, which is available in the docket. 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. Final Tolerance Action
A. EPA's Safety Determination
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for various fragrance components including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with various fragrance components follows.
B. Toxicological Profile
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by the chemicals listed 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
( printed page 51129)
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 3 chemicals had in silico carcinogenicity alerts, JECFA and EFSA 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.
C. 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/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
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 III, which is defined as chemicals of simple structure and efficient modes of metabolism, suggesting low oral toxicity. Fragrance components identified with more than one Cramer Class will default to the more conservative (higher) Cramer Class
i.e.
fragrance component identified with a Cramer Class II and III will default to Cramer Class III. Therefore, the NOEL of 0.15 mg/kg/day is selected as the point of departure for all exposure scenarios assessed (chronic dietary, incidental oral, dermal and inhalation exposures).
D. 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 exemption at a concentration not to exceed 5 ppm for each of the listed fragrance components as well 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 and the Estimated Daily Intake. 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.”
Based on the lack of toxicity in the available database, EPA has not found these various fragrance components to share a common mechanism of toxicity with any other substances, and these various fragrance components do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that these various fragrance components do not 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
E. 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
( printed page 51130)
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 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.
F. 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 14,000 to 250,000, while for residential post-application exposure scenarios, MOEs ranged from 17,000 to 35,000. These MOEs are greater than the level of concern (LOC) of 100 and therefore are not of concern. The short-term aggregate MOE is 8,300 for adults and 10,700 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 0.20% of the cPAD for the U.S. population and 0.34% 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 (0.34% 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.
G. 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. 136et seq.
EPA will not register any pesticide formulation for food use that contains these fragrance components in excess of 5 ppm in the final pesticide formulation.
H. 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 antimicrobial 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 5 ppm under 40 CFR 180.940(a).
In addition to the substantive changes described in this document, EPA is also taking the opportunity to make one-time, non-substantive changes to correct alphabetization, capitalization, and formatting inconsistencies in Table 1 to Paragraph (a) of 40 CFR 180.940.
This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408 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.
This action does not impose an information collection burden under the PRA 44 U.S.C. 3501et seq.,
because it does not contain any information collection activities.
D. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601et seq.
The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule is not subject to the APA but is subject to FFDCA section 408(d), which does not require notice
( printed page 51131)
and comment rulemaking to take this action in response to a petition.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, EPA's 2021
Policy on Children's Health
applies to this action.
This rule finalizes tolerance actions under the FFDCA, which 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 . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in the pesticide-specific registration review documents, located in the applicable docket at
https://www.regulations.gov.
I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801et seq.,
and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action does not meet the criteria set forth in 5 U.S.C. 804(2).
Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions).
* * * * *
(a) * * *
( printed page 51132)
Table 1 to Paragraph (
a
)
Pesticide chemical
CAS Reg. No.
Limits
Acetal
105-57-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Acetaldehyde ethyl cis-3-hexenyl acetal
28069-74-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
Acetanisole
100-06-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
Acetic acid
64-19-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Acetic acid, octyl ester
112-14-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
Acetoin
513-86-0
When ready for use, the end-use concentration is not to exceed 33 ppm.
2′-Acetonaphthone
93-08-3
When ready for use, the end-use concentration is not to exceed 5 ppm.
Acetophenone
98-86-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
4-Acetyl-6-t-butyl-1,1-dimethylindan
13171-00-1
When ready for use, the end-use concentration is not to exceed 33 ppm.
Adipic acid
124-04-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Alcohols, C
16-18
, distn. residues
68603-17-8; 1190630-03-5
None.
Alkenes, C
18-22
, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from C
16-18
alcs. manuf
1430895-61-6
None.
Alkenes, C
18-22
, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from C
20-22
alcs. manuf
1430895-62-7
None.
Alkylbenzene sulfonates (branched and linear) of chain lengths C
10
-C
16
, including benzenesulfonic acid, dodecyl and benzenesulfonic acid, dodecyl-, sodium salt
27176-87-0; 25155-30-0
When ready for use, the end-use concentration is not to exceed 700 ppm.
Alkyl cylcohexylpropionate
2705-87-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
( printed page 51133)
α-Alkyl-ω-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons
When ready for use, the end-use concentration is not to exceed 300 ppm.
Hydroxynonanoic acid, δ-lactone
3301-94-8
When ready for use, the end-use concentration is not to exceed 100 ppm.
4-(p-Hydroxyphenyl)-2-butanone
5471-51-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
5-Hydroxyundecanoic acid lactone
710-04-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
Hypochlorous acid
7790-92-3
When ready for use, the end-use concentration of all hypochlorous acid chemicals in the solution is not to exceed 200 ppm determined as total available chlorine.
Hypochlorous acid, sodium salt
7681-52-9
When ready for use, the end-use concentration of all hypochlorous acid chemicals in the solution is not to exceed 200 ppm determined as total available chlorine.
Hyssop oil (Hyssopus officinalis L.)
8006-83-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
1H-Indole
120-72-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Iodine
7553-56-2
When ready for use, the total end-use concentration of all iodide-producing chemicals in the solution is not to exceed 25 ppm of titratable iodine.
α-Ionone
127-41-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
γ-Ionone
79-76-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
α-Irone
79-69-6
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 benzoate
94-46-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl 3-(2-furan)propionate
105-01-1
When ready for use, the end-use concentration is not to exceed 5 ppm.
Isoamyl butyrate
106-27-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoamyl cinnamate
7779-65-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoamyl isovalerate
659-70-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
( printed page 51147)
Isoamyl phenylacetate
102-19-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoamyl propionate
105-68-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoamyl salicylate
87-20-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoborneol
124-76-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobornyl acetate
125-12-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl acetate
110-19-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl angelate
7779-81-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl benzoate
120-50-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl 2-butenoate
589-66-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl butyrate
539-90-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl cinnamate
122-67-8
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.
Isobutyl 3-(2-furan)propionate
105-01-1
When ready for use, the end-use concentration is not to exceed 5 ppm.
2-Isobutyl-3-methoxypyrazine
24683-00-9
When ready for use, the end-use concentration is not to exceed 33 ppm.
2-Isobutyl-2-methyl-1,3-dioxolane-4-methanol
5660-53-7
None.
Isobutyl phenylacetate
102-13-6
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyl salicylate
87-19-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
α-Isobutylphenethyl alcohol
7779-78-4
When ready for use, the end-use concentration is not to exceed 33 ppm.
Isobutyraldehyde
78-84-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isobutyric acid
79-31-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoeugenol
97-54-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoeugenyl acetate
93-29-8
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoeugenyl benzyl ether
120-11-6
When ready for use, the end-use concentration is not to exceed 5 ppm.
Isoeugenyl methyl ether
93-16-3
When ready for use, the end-use concentration is not to exceed 5 ppm.
( printed page 51148)
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.
iso-Methyl-β-ionone
79-89-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isopropyl acetate
108-21-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Isopropylacetophenone
645-13-6
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Isopropylbenzyl alcohol
536-60-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isopropyl-3-hydroxybutyrate
54074-94-1
Solvent.
Isopropyl 2-methylbutyrate
66576-71-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
2-Isopropyl-4-methylthiazole
15679-13-7
When ready for use, the end-use concentration is not to exceed 33 ppm.
2-Isopropylphenol
88-69-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Isopropyl phenylacetaldehyde
4395-92-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isopulegol
89-79-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Isoquinoline
119-65-3
When ready for use, the end-use concentration is not to exceed 5 ppm.
Isovaleric acid
503-74-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Jasmine lactone
25524-95-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Jasmine oil (
Jasminum grandiflorum
L.)
8022-96-6
When ready for use, the end-use concentration is not to exceed 100 ppm.
Juniper oil (
Juniperus communis
L.)
8002-68-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
Labdanum oil (Cistus spp.)
8016-26-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Lactic acid (including l-lactic acid)
50-21-5, 79-33-4
When ready for use, the end-use concentration is not to exceed 10,000 ppm in antimicrobial formulations applied to food-contact surfaces in public eating places.
Lauryl acetate
112-66-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
Lauric acid
143-07-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Lauric aldehyde
112-54-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Lauryl alcohol
112-53-8
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.
( printed page 51149)
Levulinic acid
123-76-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
d-Limonene
5989-27-5
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.
Linalool acetate
115-95-7
When ready for use, the end-use concentration is not to exceed 100 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.
Linalyl acetate
115-95-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linalyl benzoate
126-64-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linalyl cinnamate
78-37-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linalyl formate
115-99-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linalyl hexanoate
7779-23-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linalyl isobutyrate
78-35-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linalyl isovalerate
1118-27-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linalyl propionate
144-39-8
When ready for use, the end-use concentration is not to exceed 100 ppm.
Linoleic acid, methyl ester
112-63-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Lipase, triacylglycerol
9001-62-1
When ready for use, the end-use concentration is not to exceed 500 ppm.
Lovage oil (Levisticum officinale Koch)
8016-31-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Mace oil (Myristica fragrans Houtt.)
8007-12-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
Magnesium oxide
1309-48-4
None.
Magnesium sulfate anhydrous
7487-88-9
When ready for use, the end-use concentration is not to exceed 4400 ppm.
Magnesium sulfate heptahydrate
10034-99-8
When ready for use, the end-use concentration is not to exceed 4400 ppm.
Magnesium sulfate hexahydrate
7830-18-1
When ready for use, the end-use concentration is not to exceed 4400 ppm.
Magnesium sulfate monohydrate
14168-73-1
When ready for use, the end-use concentration is not to exceed 4400 ppm.
( printed page 51150)
Magnesium sulfate pentahydrate
5553-21-6
When ready for use, the end-use concentration is not to exceed 4400 ppm.
Magnesium sulfate tetrahydrate
24378-31-2
When ready for use, the end-use concentration is not to exceed 4400 ppm.
Magnesium sulfate trihydrate
15320-30-6
When ready for use, the end-use concentration is not to exceed 4400 ppm.
Maltyl isobutyrate
65416-14-0
When ready for use, the end-use concentration is not to exceed 33 ppm.
p-Mentha-1,8-dien-7-ol
536-59-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Mentha-1,8-dien-7-yl acetate
15111-96-3
When ready for use, the end-use concentration is not to exceed 100 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.
Menthol
15356-70-4; 89-78-1; 1490-04-6
When ready for use, the end-use concentration is not to exceed 100 ppm.
4-Mercapto-4-methyl-2-pentanone
19872-52-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Methane sulfonic acid
75-75-2
When ready for use, the end use concentration is not to exceed 5,000 ppm.
When ready for use, the end-use concentration of all quaternary chemicals in solution is not to exceed 400 ppm of active quaternary compound.
Quaternary Ammonium Compounds: n-alkyl (C
12-14
) dimethyl ethylbenzyl ammonium chloride, average molecular weight (in amu), 377 to 384
85409-23-0
When ready for use, the end-use concentration of all quaternary chemicals in solution is not to exceed 400 ppm of active quaternary compound.
Quaternary ammonium compounds n-alkyl (C
12
-C
18
) dimethyl ethylbenzyl ammonium chloride average molecular weight (in amu) 384
None
When ready for use, the end-use concentration of all quaternary chemicals in the solution is not to exceed 200 ppm of active quaternary compound.
Quaternary ammonium compounds, Di-n-Alkyl (C
8
-
10
) dimethyl ammonium chloride, average molecular weight (in amu) 332 to 361
None
When ready for use, the end-use concentration of these specific in quaternary ammonium compounds is not to exceed 240 ppm of active quaternary ammonium compound; the end-use concentration of all quaternary chemicals in the solution is not to exceed 400 ppm of active quaternary compound.
When ready for use, the end-use concentration of these specific ammonium compounds is not to exceed 400 ppm of active quaternary ammonium compound.
Rose absolute (
Rosa
spp.)
8007-01-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
( printed page 51160)
Rue oil (Ruta graveolens L.)
8014-29-7
When ready for use, the end-use concentration is not to exceed 33 ppm.
Salicylaldehyde
90-02-8
When ready for use, the end-use concentration is not to exceed 100 ppm.
Sandalwood yellow oil (Santalum album L.)
8006-87-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Santalol
11031-45-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
cis-α-Santalol
115-71-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
cis-β-Santalol
77-42-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Schinus molle oil (
Schinus molle
L.)
68917-52-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
Sclareol
515-03-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
Sclareolide
564-20-5
When ready for use, the end-use concentration is not to exceed 5 ppm.
Silver ions resulting from the use of electrolytically-generated silver ions stabilized in citric acid as silver dihydrogen citrate (does not include metallic silver)
14701-21-4
When ready for use, the end-use concentration of silver ions is not to exceed 50 ppm of active silver.
Sodium 2-benzyl-4-chlorophenate
3184-65-4
When ready for use, the end-use concentration is not to exceed 2080 ppm.
Sodium bisulfate
7681-38-1
When ready for use, the end-use concentration is not to exceed 2,000 ppm.
Sodium dioctyl sulfosuccinate
577-11-7
None.
Sodium lauroyl sarcosinate
137-16-6
When ready for use, the end-use concentration is not to exceed 10,000 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
Stearic acid
57-11-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
Storax (
Liquidambar
spp.)
8046-19-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
Sulfuric acid
7664-93-9
Food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils in antimicrobial formulations. Not to exceed 600 ppm.
Sulfuric acid monododecyl ester, sodium salt (sodium lauryl sulfate)
151-21-3
When ready for use, the end-use concentration is not to exceed 350 ppm.
Tagetes oil (
Tagetes erecta
L.)
8016-84-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Tall oil fatty acid
61790-12-3
Solvent/carrier.
Tangerine oil (Citrus reticulata blanco)
8008-31-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Tartaric acid
87-69-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
( printed page 51161)
DL-Tartaric acid
133-37-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
α-Terpinene
99-86-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
γ-Terpinene
99-85-4
When ready for use, the end-use concentration is not to exceed 100 ppm.
α-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.
1-Tetradecanol
112-72-1
None.
α-Terpinyl propionate
80-27-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
Tetraacetylethylenediamine (TAED)
10543-57-4
None.
Tetradecanoic acid, ethyl ester
124-06-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
Tetradecanoic acid, 1-methylethyl ester
110-27-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Tetrahydrogeranial
5988-91-0
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.
Tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran
16409-43-1
When ready for use, the end-use concentration is not to exceed 33 ppm.
Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one
32764-98-0
When ready for use, 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.
Thiogeraniol
39067-80-6
When ready for use, the end-use concentration is not to exceed 100 ppm.
Thymol (8CA)
89-83-8
When ready for use, the end-use concentration is not to exceed 100 ppm.
Thyme (
Thymus Vulgaris) Oil
84929-51-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
Tolu, balsam, gum (
Myroxylon
spp.)
9000-64-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Tolylacetaldehyde
104-09-6
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Tolyl acetate
140-39-6
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Tolyl isobutyrate
103-93-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Tolyl 3-methylbutyrate
55066-56-3
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Tolyl octanoate
59558-23-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
p-Tolyl phenylacetate
101-94-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
( printed page 51162)
2-(p-Tolyl)propionaldehyde
99-72-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
trans-1,3,3,3-Tetrafluoroprop-1-ene
29118-24-9
None.
1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3-dichloro-, sodium salt
2893-78-9
When ready for use, the end-use concentration of all di- or trichloroisocyanuric acid chemicals in the solution is not to exceed 100 ppm determined as total available chlorine.
2-Tridecanal
7774-82-5
When ready for use, the end-use concentration is not to exceed 100 ppm.
2-Tridecanone
593-08-8
When ready for use, the end-use concentration is not to exceed 33 ppm.
Triethyl citrate
77-93-0
When ready for use, the end-use concentration is not to exceed 100 ppm.
Triethylene glycol
112-27-6
None.
p-α,α-Trimethylbenzyl alcohol
1197-01-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
2,6,6-Trimethyl-1-cyclohexen-1-acetaldehyde
472-66-2
When ready for use, the end-use concentration is not to exceed 100 ppm.
2,6,6-Trimethyl-1&2-cyclohexen-1-carboxaldehyde
432-25-7
When ready for use, the end-use concentration is not to exceed 100 ppm.
1,3,3-Trimethyl-2-norbornanyl acetate
13851-11-1
When ready for use, the end-use concentration is not to exceed 100 ppm.
3,3,5-Trimethylcyclohexanol
116-02-9
When ready for use, the end-use concentration is not to exceed 100 ppm.
Use this for formal legal and research references to the published document.
90 FR 51127
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Various Fragrance Components in Pesticide Formulations; Exemption From the Requirement for a Tolerance,” thefederalregister.org (November 17, 2025), https://thefederalregister.org/documents/2025-19913/various-fragrance-components-in-pesticide-formulations-exemption-from-the-requirement-for-a-tolerance.