Document ID: EPA-HQ-OPP-2021-0639-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-10-21T04:00Z

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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, Branch Chief Inert Assessment Branch (IAB) 703-308-1846
 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:

 Spring Regulatory Sciences (SRS) on behalf of Colorants Solutions USA LLC 
IN-11612 

EPA has received a pesticide petition (IN-11612) from Spring Regulatory Sciences on behalf of Colorants Solutions USA LLC, 4000 Monroe Road, Charlotte, NC 28205 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 2,5-Furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether (CAS Number: 1812871-29-6), consisting of a minimum number average molecular weight of 11000 daltons, <2% of its oligomeric material weighing below 500 daltons and <5% of its oligomeric material weighing less than 1,000 daltons in or on the raw agricultural commodity growing crops pre or post-harvest 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. 

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). 2,5-Furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether 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 2 of the exemption criteria specified in 40 CFR 723.250(e): The polymer's number average molecular weight is greater than or equal to 10000 daltons (11000 daltons), the polymer contains less than 2% oligomeric material below MW 500 (0%) and less than 5% oligomeric material below MW 1,000 (0%) Thus, the polymer 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 polymers.

 Residue Chemistry

        Plant metabolism. NA-Remove: Polymer exemption
          Analytical method. 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 
          Acute toxicity. NA-Remove: Polymer exemption
          Genotoxicty. NA-Remove: Polymer exemption
          Reproductive and developmental toxicity. NA-Remove: Polymer exemption
          Subchronic toxicity. NA-Remove: Polymer exemption
          Chronic toxicity. [There is no evidence that 2,5-Furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2- aminopropyl Me ether is carcinogenic. Therefore, a cancer dietary exposure assessment is not necessary to assess cancer risk.
          Animal metabolism. NA-Remove: Polymer exemption
          Metabolite toxicology. NA-Remove: Polymer exemption

          Endocrine disruption. 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 2,5-Furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether 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.

  Aggregate Exposure
        Dietary 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). 
          EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated 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.

  Cumulative Effects

      Section 408(b)(2)(D)(v) 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 pesticide's residues and "other substances that have a common mechanism of toxicity".

Spring Regulatory Sciences has not found 2,5-Furandione, polymer with ethenylbenzene,
octyl imide, imide with polyethylene-polypropylene 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 2-aminopropyl Me ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, SRS 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 EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/
cumulative.

 Safety Determination

1. U.S. population. Based on the conformance to the criteria used to identify a
low-risk polymer, SRS 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.

2. Infants and children. Section 408(b)(2)(C) 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 2- aminopropyl Me ether, SRS has not used a safety factor analysis to assess the risk. For
the same reasons the additional tenfold safety factor is unnecessary.

 International Tolerances
SRS is not aware of any country requiring a tolerance for the 2,5-Furandione,
polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol
2-aminopropyl Me ether nor have any CODEX Maximum Residue Levels been
established for any food crops at this time.