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Federal Register / Vol. 86, No. 243 / Wednesday, December 22, 2021 / Rules and Regulations
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developmental-specific 5th percentile NOAELs calculated by van Ravenzwaay et al. 2011 indicate low potential for offspring susceptibility, and the conservative assumptions made in the exposure assessment are unlikely underestimate risk.
E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD aPAD and chronic PAD cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effects resulting from a single oral exposure were identified and no acute dietary endpoint were selected for any of the fragrance components. Therefore, the fragrance components listed in Unit II are not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to the fragrance components listed in Unit II from food and water will utilize 48% of the cPAD
for children 1 to 2 years old, the population group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water considered to be a background exposure level.
The fragrance components listed in Unit II are currently used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to the fragrance components listed in Unit II.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 109 for both adult males and females. EPA has concluded the combined short-term aggregated food, water, and residential pesticide
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exposures result in an aggregate MOE of 135 for children. Because EPAs level of concern for the fragrance components listed in Unit II of this document is an MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water considered to be a background exposure level. An intermediate-term adverse effect was identified; however, the fragrance components listed in Unit II are not currently used as an inert ingredient in pesticide products that are registered for any use patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure.
Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD which is at least as protective as the POD used to assess intermediateterm risk, no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediateterm risk for various fragrance components.
5. Aggregate cancer risk for U.S.
population. No structural alerts for cancer that are relevant to humans were identified for the fragrance components listed in Unit II Therefore, there is low concern for genotoxicity/carcinogenicity in humans and the assessment under the TTC value for non-cancer risks is protective for all risks, including carcinogenicity.
6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to residues of the fragrance components listed in Unit II.
V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of the fragrances listed in unit II in or on any food commodities. EPA is establishing a limitation on the amount of the fragrances listed in unit II that may be used in pesticide formulations. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act FIFRA, 7 U.S.C.

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136 et seq. EPA will not register any pesticide formulation for food use that exceeds 100 ppm of any one of the fragrances listed in unit II in the final pesticide formulation.
B. International Residue Limits In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits MRLs established by the Codex Alimentarius Commission Codex, as required by FFDCA section 408b4.
The Codex Alimentarius is a joint United Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA
may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408b4 requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL
for the fragrance components listed in Unit II.
VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940a for ddecalactone CAS Reg. No. 705862, gdecalactone CAS Reg. No. 706149, dimethyl-1-octanol CAS Reg. No. 106
218, 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. 97621, ethyl laurate CAS Reg. No. 106332, ethyl octanoate CAS Reg. No. 10632
1, ethyl nonanoate CAS Reg. No. 123
295, g-heptalactone CAS Reg. No.
105215, g-hexalactone CAS Reg. No.
695067, cis-3-hexenyl butyrate CAS
Reg. No. 16491364, cis-3-hexenyl hexanoate CAS Reg. No. 31501118, 3-hexenyl 2-methylbutanoate CAS Reg.
No. 10094414, hexyl butyrate CAS
Reg. No. 2639636, hexyl hexanoate CAS Reg. No. 6378650, hexyl isobutyrate CAS Reg. No. 2349077, hexyl propionate CAS Reg. No. 2445
763, 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

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