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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Rules and Regulations
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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.
The polymers number average molecular weight MW of 11,239
daltons is greater than 10,000 daltons.
However, the polymer contains less than 2% oligomeric material below MW
500 <0.1% and less than 5%
oligomeric material below MW 1,000 <0.1%.
Thus, 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2aminopropyl Me 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 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether.
IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2,5furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2aminopropyl Me ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylenepolypropylene glycol 2-aminopropyl Me ether is 11,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylenepolypropylene glycol 2-aminopropyl Me 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
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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 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylenepolypropylene glycol 2-aminopropyl Me ether to share a common mechanism of toxicity with any other substances, and 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2aminopropyl Me 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 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me 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 https
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 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2aminopropyl Me ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
VII. Determination of Safety Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether.

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VIII. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
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.
The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting 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 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2aminopropyl Me ether.
IX. Conclusion Accordingly, EPA finds that exempting residues of 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylenepolypropylene glycol 2-aminopropyl Me ether from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408d in response to a petition submitted to the Agency. The Office of Management and Budget OMB has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review 58 FR 51735, October 4, 1993. Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 66
FR 28355, May 22, 2001 or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885,
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