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Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Rules and Regulations
validity, completeness and reliability and the relationship of this information 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. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure to a-terpineol, including exposure resulting from the exemption established by this action.
EPAs assessment of exposures and risks associated with a-terpineol follows.

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A. Toxicological Profile The acute oral and dermal toxicity of a-terpineol and related compounds is low. The acute oral LD50 lethal dose in rats is 2,830 milligrams/kilogram mg/
kg for a-terpineol and 4,300 mg/kg for an a-terpineol/b-terpineol mixture. The dermal LD50 in rabbits for terpineol is >3,000 mg/kg. No acute inhalation, primary eye irritation or dermal sensitization studies are available in the database.
The repeated-dose toxicity for aterpineol and related compounds is low.
The only effects observed decreased food intake, increased cholesterol and increased triacylglycerol occurred at the limit dose following treatment with a-terpineol for 14 days. No adverse effects were observed in a 20-week rat study with a-terpenyl acetate or in a combined repeated dose with reproduction/developmental screening study in rats with terpineol.
No oral chronic or carcinogenicity studies are available for a-terpineol.
However, there are no structural alerts for carcinogenicity for a-terpineol and there was no evidence of increased lung tumor incidence in mice treated intraperitoneally with a-terpineol for 20
weeks, when compared to controls.
There is also low concern for genotoxicity or mutagenicity, based on negative results in mammalian genotoxicity tests and most Ames tests.
Neurotoxicity and immunotoxicity toxicity studies are not available for review. However, no evidence of neurotoxicity or immunotoxicity is seen in the available studies.
B. Toxicological Points of Departure/
Levels of Concern No toxicological endpoint of concern for a-terpineol has been identified in the database.
C. Exposure Assessment 1. Dietary exposure. Dietary exposure food and drinking water may occur from the proposed uses of a-terpineol e.g., eating foods treated with pesticide formulations containing a-terpineol,
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and drinking water exposures. There is also potential for non-pesticide dietary exposure since a-terpineol is a natural constituent of orange juice and is also used as a food additive. However, no endpoint of concern was identified.
Therefore, an acute or chronic dietary exposure assessment is not necessary for a-terpineol.
2. Residential exposure. The proposed pre-harvest use of a-terpineol in crops is not anticipated to result in residential exposure. Residential exposure to aterpineol may occur from existing pesticide uses as well as from nonpesticide products that may be used in and around the home, such as cosmetics, perfumes, toiletries, and cleaning products. However, based on the absence of a toxicological endpoint of concern, a quantitative assessment for residential exposure was not performed.
3. Cumulative effects from substances with a common mechanism of toxicity.
Section 408b2Dv of FFDCA
requires that, when considering whether to establish, modify, or revoke a tolerance or exemption, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.
EPA has not made a common mechanism of toxicity finding as to aterpineol and any other substances and a-terpineol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that a-terpineol has a common mechanism of toxicity with other substances. For information regarding EPAs efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPAs website at https
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children Section 408b2C of FFDCA
provides that EPA shall apply an additional tenfold 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 unless EPA concludes that a different margin of safety will be safe for infants and children. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.
Based on the low toxicity of a-terpineol in the available studies, EPA has concluded that there are no
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toxicological endpoints of concern for the U.S. population, including infants and children.
E. Aggregate Risks and Determination of Safety Taking into consideration all available information on a-terpineol, EPA has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to aterpineol residues. Therefore, the establishment of an exemption from the requirement of a tolerance under 40 CFR
180.920 for residues of a-terpineol when used as a solvent inert ingredient in pesticide formulations at rates of 5% of the formulation in pre-harvest applications to crops is safe under FFDCA section 408.
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 a-terpineol in or on any food commodities. EPA is establishing a limitation on the amount of a-terpineol that may be used in pesticide formulations applied preharvest. This limitation 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 exceeds 5% a-terpineol 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.
Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standardssetting 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 a-terpineol.

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