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Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Rules and Regulations There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has limited the maximum concentration of ADAOs to not more than 1,350 ppm at the enduse concentration in pesticide formulations. This limitation is based on the Agencys risk assessment, which can be found at http
www.regulations.gov in document C10C18-Alkyldimethylamine oxides;
Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations in docket ID number EPAHQOPP20210164.

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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
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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 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 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 ADAOs, including exposure resulting from the exemption established by this action.
EPAs assessment of exposures and risks associated with ADAOs follows.
On October 7, 2009, EPA published in the Federal Register a final rule establishing an exemption from the requirement of a tolerance for residues of ADAOs when used as an inert ingredient in pesticide formulations applied to raw agricultural commodities preand post-harvest. See 74 FR 51474
FRL84373. That document contains a summary of the toxicological profile, toxicological points of departure/levels of concern, certain assumptions for exposure assessment, and the Agencys determination regarding the childrens safety factor, which have not changed except as described below.
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
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the nature of the adverse effects caused by ADAOs as well as the no-observedadverse-effect-level NOAEL and the lowest-observed-adverse-effect-level LOAEL from the toxicity studies are discussed in Unit IV.A of the final rule published in the Federal Register of October 7, 2009 74 FR 51474 FRL
84373.
B. Toxicological Points of Departure/
Levels of Concern Once a pesticides 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 levelgenerally referred to as a population-adjusted dose PAD or a reference dose RfDand 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 http
www.epa.gov/pesticides/factsheets/
riskassess.htm.
C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ADAOs, EPA considered exposure under the proposed exemption from the requirement of a tolerance. To assess dietary exposures from ADAOs in food, the Agency calculated the Daily Dietary Dose DDD and the Estimated Daily Intake EDI using U.S. Food and Drug Administration FDA Food Contact Surface Sanitizing Solution Dietary Exposure Assessment Model.
EPAs assessment used FDAs default assumptions for the amount of residual solution or quantity of solution remaining on the treated surface without rinsing with potable water 1 mg/cm2; surface area of the treated surface which comes into contact with food 4,000 cm2; and the pesticide
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