Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Rules and Regulations 92821 

MISSOURI—2015 8-HOUR OZONE NAAQS—Continued 

[Primary and Secondary] 

Designated area 1

Designation Classification 

Date 2 Type Date 2 Type 

Franklin County (part). 

Boles Township: 

Jefferson County ............................................................... July 14, 2021 3.

St. Charles County. 

St. Louis County. 

City of St. Louis. 

* * * * * * * 

1 Includes any Indian country in each county or area, unless otherwise specified. The EPA is not determining the boundaries of any area of Indian country in this table, including any area of Indian country located in the larger designation area. The inclusion of any Indian country in the 

designation area is not a determination that the state has regulatory authority under the Clean Air Act for such Indian country. 2This date is August 3, 2018, unless otherwise noted. 

3EPA revised the nonattainment boundary in response to a court decision, which did not vacate any designations for the 2015 ozone NAAQS, 

but which remanded the designation for the identified county. Because this additional area is part of a previously designated nonattainment area, 

the implementation dates for the overall nonattainment area (e.g., the August 3, 2021 attainment date) remain unchanged regardless of this later 

designation date. 

* * * * * 

[FR Doc. 2024–27382 Filed 11–22–24; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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, dairyprocessing equipment, and foodprocessing 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 https://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room and the OPP 

docket is (202) 566–1744. Please review 

the visitor instructions and additional 

information about the docket 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. 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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title-40. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(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 


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92822 Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Rules and Regulations 

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/HomePage?

ReadForm. 

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: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be CBI 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at https://

www.epa.gov/dockets/where-sendcomments-epa-dockets#express. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Petition for Exemption 

In the Federal Register of June 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-pMenthene-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-en2-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-Hydroxy2,5-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); alphaAmylcinnamaldehyde (CAS Reg. No. 

122–40–7); a-Butylcinnamaldehyde 

(CAS Reg. No. 7492–44–6); aHexylcinnamaldehyde (CAS Reg. No. 

101–86–0); a-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,lIsomenthone (CAS Reg. No. 491–07–6); 

d-Camphor (CAS Reg. No. 464–49–3); dFenchone (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 foodprocessing 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, https://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 


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Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Rules and Regulations 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 noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (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 


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assessment process, see https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-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 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 nonoccupational, 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-tomouth 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 https:// 

www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

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. Shortterm 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 shortterm 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 


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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 foodcontact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing 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 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 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. a-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 


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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-ethylff. a-Hexylcinnamaldehyde 

gg. 4-Hydroxy-2,5-dimethyl-3(2H)- 

furanone 

hh. 2-Isobutyl-3-methoxypyrazine 

ii. a-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-epoxytt. 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- 

methylvvv. Rue oil (Ruta graveolens L.) 

www. Tetrahydro-4-methyl-2-(2- 

methylpropen-1-yl)pyran 

xxx. Tetrahydro-6-(3-pentenyl)-2Hpyran-2-one 

yyy. Theaspirane 

zzz. 2-Tridecanone 

aaaa. 2-Undecanone 

The additions read as follows: 

§ 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-dimethylindan ............................................ 13171–00–1 When ready for use, 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-carboxaldehyde ........................................... 120–57–0 When ready for use, the end-use concentration is not to exceed 33 ppm. 

*******

Bicyclo[2.2.1]heptan-2-one, 1,7,7-trimethyl-, (1R, 4R)- .............. 464–49–3 When ready for use, the end-use concentration is not to exceed 33 ppm. 

*******

a-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 leucadendron L.) .................................... 8008–98–8 When ready for use, 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. 


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TABLE 1 TO PARAGRAPH (a)—Continued 

Pesticide chemical CAS Reg. No. Limits 

*******

Cardamom (Elettaria cardamomum (L.) Maton) ......................... 85940–32–5 When ready for use, the end-use concentration is not to exceed 33 ppm. 

Cardamom seed oil (Elettaria cardamomum (L.) Maton) ........... 8000–66–6 When ready for use, the end-use concentration is not to exceed 33 ppm. 

*******

Cyclopentaneacetai acid, 3-oxo-2-pentyl-, methyl ester ............ 24851–98–7 When ready for use, the end-use concentration is not to exceed 33 ppm. 

Cyclopropanemethanol, 1-methyl-2-[(1,2,2- 

trimethylbicyclo[3.1.0]hex-3-yl)methyl]-.

198404–98–7 When ready for use, the end-use concentration is 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-cyclopentadione ............................................... 13494–06–9 When ready for use, 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-2-one .......................................... 689–67–8 When ready for use, 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. 

*******

a-Hexylcinnamaldehyde .............................................................. 101–86–0 When ready for use, the end-use concentration is not to exceed 33 ppm. 


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TABLE 1 TO PARAGRAPH (a)—Continued 

Pesticide chemical CAS Reg. No. Limits 

*******

4-Hydroxy-2,5-dimethyl-3(2H)-furanone ..................................... 3658–77–3 When ready for use, 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. 

*******

a-Isobutylphenethyl alcohol ........................................................ 7779–78–4 When ready for use, 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-methylpropyl)pyrazine ....................................... 24168–70–5 When ready for use, 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-cyclopenten-1-one ............................. 1128–08–1 When ready for use, the end-use concentration is not to exceed 33 ppm. 

3-Methyl-2-(2E)-2-penten-1-yl-2-cyclopenten-1-one ................... 6261–18–3 When ready for use, the end-use concentration is not to exceed 33 ppm. 


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TABLE 1 TO PARAGRAPH (a)—Continued 

Pesticide chemical CAS Reg. No. Limits 

3-Methyl-2-(2-pentenyl)-2-cyclopenten-1-one, (Z)- ..................... 488–10–8 When ready for use, 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-oxathiane ................................................. 67715–80–4 When ready for use, the end-use concentration is not to exceed 33 ppm. 

* * * * * * * 

5-Methyl-2-thiophenecarboxyaldehyde ....................................... 13679–70–4 When ready for use, the end-use concentration is not to exceed 33 ppm. 

* * * * * * * 

3-Methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol .... 67801–20–1 When ready for use, the end-use 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, 1-methyl-4-(1-methylethyl)- .......... 470–67–7 When ready for use, 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-methyl- ........................................ 118–71–8 When ready for use, the end-use concentration is not to exceed 33 ppm. 


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TABLE 1 TO PARAGRAPH (a)—Continued 

Pesticide chemical CAS Reg. No. Limits 

*******

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-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. 

*******

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 93 

45 CFR Parts 46 and 73 

Final Scientific Integrity Policy 

AGENCY: Office of the Assistant 

Secretary for Planning and Evaluation, 

Office of the Secretary, HHS. 

ACTION: Policy statement. 

SUMMARY: The Department of Health and 

Human Services (HHS) is publishing its 

Scientific Integrity Policy to increase 

access to and raise awareness of the 

Policy. 

DATES: The effective date of the Policy 

is October 16, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Karen Wehner, Ph.D., Scientific 

Integrity Officer, Office of Science and 

Data Policy, Office of the Assistant 

Secretary for Planning and Evaluation, 

Office of the Secretary, HHS at 240– 

453–8435 or scientificintegrity@hhs.gov. 

SUPPLEMENTARY INFORMATION: Scientific 

integrity plays a vital role in the mission 

of HHS. Ensuring integrity in science 

throughout the Department allows HHS 

to foster and produce high-quality 

science, communicate effectively with 

the public, and base critical policy 

decisions on trustworthy and rigorous 

scientific findings. HHS has adopted a 

Department-wide scientific integrity 

policy to further strengthen scientific 

integrity and evidence-based 

policymaking throughout the 

Department. 

The Scientific Integrity Policy of the 

U.S. Department of Health and Human 

Services (Policy) was approved on 

September 16, 2024. The finalized 

Policy was announced to the HHS 

community and posted on the HHS 

scientific integrity website, at https://

www.hhs.gov/programs/research/ 

scientificintegrity/index.html, on 

September 30, 2024. The effective date 

of the Policy is October 16, 2024. 

The content of the finalized Policy, 

reformatted to conform to the 

requirements of the Federal Register, is 

provided below. This content is also 

available in its original format on the 

HHS website, at https://www.hhs.gov/ 

sites/default/files/hhs-scientificintegrity-policy.pdf. 

The Scientific Integrity Policy of the 

U.S. Department of Health and Human 

Services 

Purpose 

The purpose of this policy is to 

promote a continuing culture of 

scientific integrity at the U.S. 

Department of Health and Human 

Services (HHS). This policy aims to 

ensure the integrity of all aspects of 

HHS scientific activities, including 

proposing, conducting, reviewing, 

managing, and communicating about 

science and scientific activities, and 

using the results of science to inform 

policy and program decision-making. 

Core Values That Support Scientific 

Integrity at HHS 

The success of HHS’s mission to 

enhance the health and well-being of all 

Americans depends on the development 

and use of accurate, complete, and 

timely scientific and technical 

information. Scientific integrity requires 

that such information be developed 

under and subjected to well-established 

scientific processes, free from 

inappropriate interference that 

undermines impartiality, 

nonpartisanship, or professional 

judgment. HHS agencies work to 

maximize the quality, accuracy, 

objectivity, utility, and timeliness of the 

scientific and technological information 

they produce, use, and disseminate. In 

turn, this information enables HHS to 

employ innovative approaches to 

effectively address the many public 

health and human services challenges 

that our work targets. These efforts 

allow accurate, complete, and timely 

scientific and technical information to 

improve the design, delivery, and 

impact of HHS policies and programs, 

and support equity, justice, and trust. 

Responsibility for upholding scientific 

integrity lies with the entire scientific 

ecosystem, including all HHS 

employees, its contractors and grantees, 

and those engaged in science and 

scientific activities outside HHS. 

Definition of Scientific Integrity and 

Scientific Integrity Official 

HHS adopts the following Official 

Federal Definition of Scientific Integrity: 

Scientific integrity is the adherence to 

professional practices, ethical behavior, and 


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