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Federal Register / Vol. 86, No. 243 / Wednesday, December 22, 2021 / Rules and Regulations
establishing an exemption from the requirement of a tolerance for residues of d-decalactone CAS Reg. No. 70586
2, g-decalactone CAS Reg. No. 70614
9, dimethyl-1-octanol CAS Reg. No.
106218, 3,7, ethyl acetate CAS Reg.
No. 141786, ethyl butyrate CAS Reg.
No. 105544, ethyl decanoate CAS
Reg. No. 110383; ethyl heptanoate CAS Reg. No. 106309, ethyl hexanoate CAS Reg. No. 123660, ethyl isobutyrate CAS Reg. No. 9762
1, ethyl laurate CAS Reg. No. 10633
2, ethyl octanoate CAS Reg. No. 106
321, ethyl nonanoate CAS Reg. No.
123295, g-heptalactone CAS Reg.
No. 105215, g-hexalactone CAS Reg.
No. 695067, cis-3-hexenyl butyrate CAS Reg. No. 16491364, cis-3hexenyl hexanoate CAS Reg. No.
31501118, 3-hexenyl 2methylbutanoate CAS Reg. No. 10094
414, hexyl butyrate CAS Reg. No.
2639636, hexyl hexanoate CAS Reg.
No. 6378650, hexyl isobutyrate CAS
Reg. No. 2349077, hexyl propionate CAS Reg. No. 2445763, hydroxynonanoic acid, d-lactone CAS
Reg. No. 3301948, 5hydroxyundecanoic acid lactone CAS
Reg. No. 710043, isoamyl acetate CAS Reg. No. 123922, isoamyl alcohol CAS Reg. No. 123513, isoamyl butyrate CAS Reg. No. 10627
4, isobutyl acetate CAS Reg. No. 110
190, isobutyl isobutyrate CAS Reg.
No. 97858, isopropyl 2methylbutyrate CAS Reg. No. 66576
714, Lavandin oil Lavandula hybrida CAS Reg. No. 8022159, linalool CAS Reg. No. 78706, linalyl acetate CAS Reg. No.115957, g-nonalactone CAS Reg. No. 104610, g-octalactone CAS Reg. No. 104507, wpentadecalactone CAS Reg. No. 106
025, Petitgrain bigarade oil CAS Reg.
No. 8014173, a-terpineol CAS Reg.
No. 98555, terpinyl acetate isomer mixture CAS Reg. No. 8007350, Tetrahydrolinalool CAS Reg. No. 78
693, g-undecalactone CAS Reg. No.
104676, 10-undecen-1-yl acetate CAS Reg. No. 112196 when used as an inert ingredient fragrance component in pesticide formulations applied to food contact surfaces in public eating places, dairy processing equipment, and food processing equipment with enduse concentrations not to exceed 100
ppm. That document referenced a summary of the petition prepared by Verto Solutions on behalf of The Clorox Company, the petitioner, which is available in the docket, https
www.regulations.gov. There were no comments received in response to the notice of filing.

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III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients except when they have a pesticidal efficacy of their own:
Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose;
wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term inert is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
IV. Aggregate Risk Assessment and Determination of Safety Section 408c2Ai 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 408b2Aii of FFDCA
defines safe to mean that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408b2C of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that
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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 408c2A, and the factors specified in FFDCA section 408c2B, 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. EPAs assessment of exposures and risks associated with various fragrance components follows.
A. Toxicological Profile EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by various fragrance components as well as the no-observed-adverse-effect-level NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies are discussed in this unit.
The Agency assessed these fragrance components via the Threshold of toxicological concern TTC approach as outlined by the European Food Safety Authority EFSA in their 2018
proposed guidance document on the use of TTC in food safety assessment. This approach relies on the most recent evaluation of the literature on TTC as reviewed by EFSA and the World Health Organization WHO in 2016.
Information regarding the database of studies and chemicals used to derive TTCs are reviewed therein. The TTC
approach has been used by the Joint Expert Committee on Food Additives of the United Nations Food and Agriculture Organization and the World Health Organization, the former Scientific Committee on Food of the European Commission, the European Medicines Agency, and EFSA.
Thresholds of toxicological concern TTC are derived from a conservative and rigorous approach developed by
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