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Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Rules and Regulations
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establishing exemptions from the requirement of a tolerance for alcohols, C2030, ethoxylated CAS Reg. No.
68439485; alcohols, C1618, distn.
residues, ethoxylated, propoxylated CAS Reg. No. 2409830335; alcohol, C22, ethoxylated CAS Reg. No. 26636
408; polyoxy-1,2-ethanediyl, a-2butyloctyl-w-hydroxyCAS Reg. No.
60636375; 2-octyldodecan-1-ol, ethoxylated CAS Reg. No. 32128657;
and alcohols, C1620, branched, ethoxylated CAS Reg. No. 16113370
6. That document referenced a summary of the petition prepared by Spring Regulatory Sciences on behalf of Sasol Chemicals USA LLC, the petitioner, which is available in the docket, http www.regulations.gov.
There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA
determined that CAS Reg. No. 68439
485 currently has exemptions from the requirement of a tolerance under the current AAA descriptor in 40 CFR
180.910, 180.930, 180.940a, and 180.960. EPA has confirmed that the other petitioned CAS Reg. Nos. are acceptable for consideration under the current AAA descriptor. This determination is based on the Agencys risk assessments, which can be found at http www.regulations.gov in documents Alkyl Alcohol Alkoxylates AAAJITF CST 1 Inert Ingredient, Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance when used as an Inert Ingredient in Pesticide Formulations and Alkyl Alcohol Alkoxylates AAAJITF CST 1 Inert Ingredient, Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance Under 40 CFR 180.960 When Used as an Inert Ingredient in Pesticide Formulations in docket ID number EPAHQOPP20090145.
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
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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 408c2Aii 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 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 to alcohols, C1618, distn. residues, ethoxylated, propoxylated; alcohol, C22, ethoxylated;

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polyoxy-1,2-ethanediyl, a- 2butyloctyl-w-hydroxy-; 2-octyldodecan1-ol, ethoxylated; and alcohols, C1620, branched, ethoxylated, including exposure resulting from the exemptions established by this action. EPAs assessment of exposures and risks associated with the group of substances known as AAA follows.
In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for AAA, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to AAA
and established exemptions from the requirement of a tolerance for residues of those chemicals. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
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 AAA 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 previous AAA tolerance rulemaking published in the Federal Register of August 5, 2009
74 FR 38935 FRL84301.
Toxicological Points of Departure/
Levels of Concern. For a summary of the Toxicological Points of Departure/
Levels of Concern used for the safety assessment, see Unit IV.B. of the August 5, 2009 rulemaking.
Exposure Assessment. The exposure assessment associated with the 2009
rulemaking for the AAA descriptor included the potential use of all chemicals in this category and therefore no additional exposure is expected from
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