Document ID: EPA-HQ-OPP-2022-0711-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-09-23T04:00Z

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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

 Borchers Americas, Inc.
 IN-11712
 EPA has received a pesticide petition [IN-11712) from Delta Analytical Corporation, on behalf of Borchers Americas, Inc., 811 Sharon Drive, Westlake, OH 44145 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 α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane with a minimum number average molecular weight (in amu) of 9,820 (CAS Reg. No. 26301-10-0), under 40 CFR 180.960 when used as a wetting agent 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.

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 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane with a minimum average molecular weight (in amu) of 9,820 (CAS Reg. No. 26301-10-0), conforms to the definition of a polymer given in 40 CFR 723.250(b) 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 contains 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 723.250(d)(2)(ii).
      
      
      
      
      4. The polymer has not been designed to be unstable, 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.
      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, as an integral part of its composition, one or more of the following perfluoroalkyl moieties consisting of a CF3- or longer chain length:
      a. Perfluoroalkyl sulfonates (PFAS),
      b. Perfluoroalkyl carboxylates (PFAC),
      c. Fluorotelomers,
            d. Perfluoroalkyl moieties that are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule.
      8. The polymer meets option 1 of the exemption criteria specified in 40 CFR 723.250(e): The polymer's number average molecular weight is greater than or equal to 1,000 daltons 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.

Thus, the polymer meets all the terms and criteria of a Low-Risk Polymer under 40 CFR 723.250. Based on its conformance to the criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to the polymers.

 Residue Chemistry

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

  Toxicological Profile. α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane 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, α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane meets the criteria specified above for defining a low-risk polymer under 40 CFR 723.250. 

In addition, large molecular weight chemicals (>500) are not expected to be absorbed significantly via the oral, dermal or inhalation routes of exposure. Therefore, systemic toxicity is unlikely to produce adverse effects. 
          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. FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), ``may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect.'' EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane with a minimum average molecular weight (in amu) of 9,820 (CAS Reg. No. 26301-10-0) for endocrine effects may be required. This class of chemistry does not belong to a class of chemicals known or suspected of having adverse effects on the estrogen receptor or endocrine system. In addition, large molecular weight chemicals (>500) are not expected to be absorbed significantly via the oral, dermal or inhalation routes of exposure. Therefore, it is unlikely that the polymer will produce endocrine-mediated effects.] 

  Aggregate Exposure  In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).
        Dietary exposure. [NA-Remove.]
 Food. α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane 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. α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane 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. α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane 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

 α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane 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. α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane 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. α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane 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
 The Codex Alimentarius Commission (Codex) has not established a MRL for α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane and there are no maximum residue limits established for α-D-Glucopyranoside, β-D-fructofuranosyl, polymer with methyloxirane and oxirane in or on crops or commodities of which the petitioner is aware.