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Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Rules and Regulations
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prepared by the petitioner and solicited comments on the petitioners request.
The Agency did not receive any comments.
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 use 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 an exemption from the requirement of 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 . . . and specifies factors EPA is to consider in establishing an exemption.
III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks 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 finite 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 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
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identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40
CFR 723.250b and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR
723.250d. Oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9octadecanoate, methyl ether conforms to the definition of a polymer given in 40
CFR 723.250b and meets the following criteria that are used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250d2ii.
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average molecular weight MW greater than or equal to 10,000 daltons.
7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250d6.
Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250e.
8. The polymers number average MW
of 1,200 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW
1,000, and the polymer does not contain any reactive functional groups.
Thus, oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9octadecanoate, methyl ether meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to oxirane, 2-methyl-,
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polymer with oxirane, mono-9Z-9octadecanoate, methyl ether.
IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9-octadecanoate, methyl ether could be present in all raw and processed agricultural commodities and drinking water, and that nonoccupational non-dietary exposure was possible. The number average MW of oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9-octadecanoate, methyl ether is 1,200 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9octadecanoate, methyl ether conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.
V. 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, 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 found oxirane, 2-methyl-, polymer with oxirane, mono9Z-9-octadecanoate, methyl ether to share a common mechanism of toxicity with any other substances, and oxirane, 2-methyl-, polymer with oxirane, mono9Z-9-octadecanoate, methyl ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9-octadecanoate, methyl ether does not have 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 http
www.epa.gov/pesticides/cumulative.
VI. Additional Safety Factor for the Protection of Infants and Children Section 408b2C of FFDCA
provides that EPA shall apply an
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