Document ID: EPA-HQ-OPP-2019-0602-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-03-31T04:00Z

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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

 EPA Registration Division contact: [Kerry Leifer; 703-308-8811]
 INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.
 TEMPLATE:

 [Solvay USA Inc.] [IN-11344]
 EPA has received a pesticide petition ([IN-11344]) from [Solvay USA Inc.], [c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192] requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10- 16-alkyl ethers, sodium salts (where average number of moles of oxyethylene = 30) (CAS Reg. No. 68585-34-2), under 40 CFR 180.960 when used as an inert ingredient in pesticide formulations]. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

 Residue Chemistry

        Plant metabolism.
          Analytical method. [NA-Remove.]
          Magnitude of residues. [NA-Remove.]

  Toxicological Profile [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16-alkyl ethers, sodium salts meets the definition of a polymer as defined by 40 CFR 723.250. That is, it contains a sequence of at least three monomer units which are covalently bound to at least one other monomer unit or other reactant. Further, poly(oxy-1,2-ethanediyl), α- sulfo-ω-hydroxy-, C10-16-alkyl ethers, sodium salts meets the criteria specified below for defining a low-risk polymer under 40 CFR 723.250.

 The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

 The polymer only contains the elements, carbon, hydrogen, nitrogen, sulfur, and oxygen and the mono-cation, sodium (Na); therefore, it meets the criteria for elemental composition.

 The polymer is not designed or reasonably anticipated to substantially degrade, decompose, or depolymerize under normal use conditions.

 The polymer is prepared from molecules that are listed on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory or manufactured under an applicable TSCA Section 5 exemption.

 The polymer is not a water-absorbing polymer with a number average molecular weight greater than or equal to 10,000 daltons.

 The polymer does not contain, as an integral part of its composition, perfluoroalkyl moieties consisting of a CF3- or longer chain length.

 The polymer meets the exemption criteria specified in 40 CFR 723.250(e). The polymer's number average molecular weight is 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.]
          Acute toxicity. [NA-Remove.]
          Genotoxicty. [NA-Remove.]
          Reproductive and developmental toxicity. [NA-Remove.]
          Subchronic toxicity. [NA-Remove.]
          Chronic toxicity. [NA-Remove.]

          Animal metabolism. [NA-Remove.]
          Metabolite toxicology. [NA-Remove.]

          Endocrine disruption. [NA-Remove.]

  Aggregate Exposure
        Dietary exposure. [NA-Remove.]

 Food. [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16-alkyl ethers, sodium salts meets the definition and criteria for a low-risk polymer under 40 CFR 723.250; therefore, there is a reasonable certainty of no harm from dietary exposure when used as an inert ingredient in pesticide formulations.]

 Drinking water. [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16-alkyl ethers, sodium salts meets the definition and criteria for a low-risk polymer under 40 CFR 723.250; therefore, there is a reasonable certainty of no harm from drinking water exposure when used as an inert ingredient in pesticide formulations.]

 Non-dietary exposure. [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16- alkyl ethers, sodium salts meets the definition and criteria for a low-risk polymer under 40 CFR 723.250; therefore, there is a reasonable certainty of no harm from non-dietary exposure when used as an inert ingredient in pesticide formulations.]

  Cumulative Effects

 [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16-alkyl ethers, sodium salts is a low-risk polymer. There is no information to suggest that any toxic effects produced by this inert ingredient would be cumulative with any other chemical.]

 Safety Determination

 U.S. population. [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16-alkyl ethers, sodium salts meets the definition and criteria for a low-risk polymer under 40 CFR 723.250; therefore, adverse effects on the U.S. population are not expected from the use of this inert ingredient in pesticide formulations.]

 Infants and children. [Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16- alkyl ethers, sodium salts meets the definition and criteria for a low-risk polymer under 40 CFR 723.250; therefore, adverse effects are not expected from the use of this inert ingredient in pesticide formulations. In addition, there is no reason to believe that infants and children will be disproportionally at risk.]

 International Tolerances
 [There is an existing tolerance exemption under 40 CFR 180.910 for the low molecular weight, non-polymeric form of this substance [α-alkyl(C6- C15)-ω- hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2-4 moles.] This petition is requesting a new tolerance exemption under 40 CFR 180.960 to cover the polymeric form of this substance, where the average moles of oxyethylene equals 30. As this petition is for the substance in the form of a polymer of low concern, the risk in its use is expected to be less than use of the current substance in its non-polymeric form.]