Document ID: EPA-HQ-OPP-2013-0383-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-07-19T04:00Z

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

EPA Registration Division contact: PV Shah (703) 308-1846
Evonik Goldschmidt Corporation
IN-10559
	EPA has received a pesticide petition (IN-10559) from Evonik Goldschmidt Corporation, PO Box 1299, Hopewell, VA  23860 proposing, 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 180.960 to establish an exemption from the requirement of a tolerance for 2,5-Furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated, minimum number average molecular weight (in AMU) 5,816 and CAS Reg. No. 1062609-13-5 under 40 CFR 180.960 when used as an inert ingredient (functioning as a dispersant) 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.
A. Residue Chemistry
	1. Plant metabolism.
	2. Analytical method. NA-Remove
	3. Magnitude of residues. NA-Remove
B. Toxicological Profile
	1. Acute toxicity.  NA-Remove
	2. Genotoxicty. NA-Remove
	3. Reproductive and developmental toxicity. NA-Remove
	4. Subchronic toxicity. NA-Remove
	5. Chronic toxicity. NA-Remove
	6. Animal metabolism. NA-Remove
	7. Metabolite toxicology. NA-Remove
	8. Endocrine disruption. NA-Remove
	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, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated 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 functional group equivalent weight (FGEW) is greater than 5000 daltons despite containing a cationic quaternary ammonium group.   Further, the polymer is net charge neutral as it is a zwitter ion containing both anionic and cationic groups.
     
  2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

  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 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.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e)(1).

  7. The polymer's number average MW of 5,816 daltons and contains approximately 1.1% oligomeric material below MW 500 and 1.7% material below MW 1000, therefore satisfying the number average molecular weight and oligomeric content requirement specified under 723.250(e)(1).

Thus, 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated 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, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated.

C. Aggregate Exposure
   For the purposes of assessing potential exposure under this exemption, EPA considered that 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated is 5,816 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, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated 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.
	1. Dietary exposure. NA-Remove
	i. Food. NA-Remove
	ii. Drinking water. NA-Remove
	2. Non-dietary exposure. NA-Remove

D. 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.'' EPA has not found 22,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated to share a common mechanism of toxicity with any other substances, and  2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiateddoes 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, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated does not have a common mechanism of toxicity with other substances. 

E. Safety Determination
	1. U.S. population. 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated, qualifying as a low concern polymer is not expected to pose toxicity risk.
	2. Infants and children. Due to the low toxicity of 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated, a safety factor analysis is not necessary.
F. International Tolerances
	The Codex has not established a MRL for 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether, 2,2' -(1, 2-diazenediyl)bis[2-methylbutanenitrile]-initiated.