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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations delivery of boxed information, please follow the instructions at http
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http
www.epa.gov/dockets.

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II. Background and Statutory Findings In the Federal Register of December 23, 2020 85 FR 83880 FRL1001771, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide tolerance petition PP 9F8781
by Valent BioSciences, LLC, 870
Technology Way, Libertyville, IL 60048.
The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the plant growth regulator 1-aminocyclopropane1-carboxylic Acid 1ACC in or on apple and stone fruit when used in accordance of good agricultural practices. That document referenced a summary of the petition prepared by the petitioner Valent BioSciences, LLC., which is available in the docket, http
www.regulations.gov. There were no comments received in response to the notice of filing.
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 exemption 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. Pursuant to FFDCA section 408c2B, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408b2C, which require 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. . . . Additionally, FFDCA section 408b2D requires that the Agency consider available information concerning the cumulative effects of a particular pesticides
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residues and other substances that have a common mechanism of toxicity.
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
III. Toxicological Profile Consistent with FFDCA section 408b2D, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its 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.
1ACC is a naturally occurring nonprotein amino acid found in all plants.
It acts as a plant growth regulator PGR, precursing ethylene, a plant hormone regulating a wide variety of vegetative and developmental processes. The only conversion of 1ACC for residues will most likely be into ethylene, which would not be measurable as ethylene is a quickly dissipating gas. Ethylene has been reviewed by EPA and is exempt from tolerance 40 CFR 180.1016.
As a biochemical pesticide, 1ACC is intended for use on apples and stone fruits for fruit thinning and enhanced return bloom and is foliarly applied with calibrated spray equipment i.e.
orchard air blast sprayer. 1ACCs mode of action is as a signaling molecule in plants to regulate fruit ripening, thinning, and enhanced return bloom. No direct application to food is expected as applications are made prefruiting, but it is possible that some trace amounts of the active ingredient may be taken up into the plant.
With regard to the overall toxicological profile of the active ingredient 1ACC, the active ingredient is of minimal toxicity through the acute oral, acute dermal and acute inhalation routes of exposure. The active ingredient is only mildly irritating to the eye and the skin; and it is not a dermal sensitizer. With regard to the subchronic toxicity, developmental toxicity, reproductive toxicity and mutagenicity data requirements for the active ingredient 1ACC, all data requirements were satisfied by guideline studies.
There were no adverse subchronic effects for any oral or dermal routes of exposure. The active ingredient was determined to be non-mutagenic, and no
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adverse effects were identified relative to either developmental toxicity or reproductive toxicity. Based on this toxicological profile, EPA did not identify any toxicological endpoints of concern for assessing risk for this chemical.
Additionally, humans have a history of safe natural exposure to 1ACC as it is present in all fruits and vegetables and, therefore, is a regular part of the human diet. With specific regard to human oral toxicity, the Agency notes that the human digestive system has evolved to accommodate 1ACC in its digestive processes.
As part of its qualitative risk assessment for 1ACC, the Agency also considered the potential for exposure to residues of 1ACC, including dietary and non-occupational exposures. EPA
concludes that dietary food and drinking water exposures are likely to be negligible, due to the short half-life and biodegradable nature of the pesticide. It is noted that dietary exposures to the residues of 1ACC are not anticipated to exceed the naturally occurring background levels as exogenously applied 1ACC is highly biodegradable. It has a half-life of less than 8.5 days on the plant and is even more biodegradable in aqueous soil conditions. No residential uses have been proposed.
Based on 1ACCs low toxicity, anticipated minimal dietary exposure, and history of safe consumption in foods, no risks of concern have been identified from aggregate exposure to 1
ACC. Similarly, no risks of concern were identified for cumulative exposures to 1ACC since no common mechanism of toxicity was identified for either 1ACC or its metabolites.
Therefore, based on the lack of toxicity and expected negligible exposures, EPA
has determined that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to 1ACC.
A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the November 16, 2020, document entitled Federal Food, Drug, and Cosmetic Act FFDCA
Considerations for 1aminocyclopropane-1-carboxylic acid ACC. This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.
IV. Determination of Safety for U.S.
Population, Infants and Children Based on the Agencys assessment, EPA concludes that there is reasonable
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