


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

EPA Registration Division contact: P.V. Shah, 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:

Triton Systems, Inc. 

1E7912

	EPA has received a pesticide petition 1E7912  from ICR, Inc., (1330 Dillon Heights Ave, Catonsville, MD) on behalf of Triton Systems, Inc. (200 Turnpike Road, Chelmsford, MA  01824)  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 to establish an exemption from the requirement of a tolerance for 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, with number average molecular weight greater than 10,000 daltons, CAS Reg. No. 35297-61-1, under 40 CFR 180.960 when used as an inert ingredient (microencapsulation) in pesticide formulations. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FFDCA; 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. [NA-Remove based on fact this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met.] 

        2.       Analytical method. [[NA-Remove based on fact this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met. In addition, Triton Systems, Inc. is submitting a low risk polymer exemption request described in 40 CFR 723.250(d). 

        3.       Magnitude of residues. [NA-Remove based on fact this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met.]

      B.    Toxicological Profile

      The definition of a polymer is given in 40 CFR 723.250(b).  

      Definition of a polymer:  1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, with number average molecular weight greater than 10,000 daltons, CAS Reg. No. 35297-61-1, conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the criteria that are used to identify low risk polymers under the TSCA Polymer Exemption Guidelines.

      1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1 is a polymer as defined by 40 CFR 723.250(b). It is composed of at least 6 monomer units. In addition, 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, consists of a simple weight majority of the polymer molecules. The monomer sequences form uninterrupted strings in the polymer and distribution of the molecular weight of the polymer is due largely to the number of monomer units in the individual molecules.


The polymer meets the following 7 criteria under 40 CFR 723.250:

   1.   The polymer 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. The polymer does contain secondary amine functionality, however it is a solid, it is not water soluble, and it will be used only in the solid phase.

   2.   The polymer 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, contains Carbon, Nitrogen, Hydrogen, and Oxygen as an integral part of its composition.

   3.   The polymer contains only Carbon, Nitrogen, Hydrogen, and Oxygen and no other elements as an integral part of its composition, except as impurities, nor 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. For the purposes of this section, degradation, decomposition, or depolymerization means those types of chemical change that convert a polymeric substance into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light, or microbial action. 

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

Additionally, the polymer, 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).  Specifically, option (2): The polymer must have a number average MW greater than or equal to 10,000 daltons and contain less than 2 percent oligomeric material below MW 500 and less than 5 percent oligomeric material below MW 1000.  

Based on measurements provided from an independent lab; 0.46% oligomeric material is less than 500 AMU and 2.08% oligomeric material less than 1000AMU.

C. Aggregate Exposure

For the purposes of assessing potential exposure under this proposed tolerance exemption, 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, could be present in all raw and processed agricultural commodities and drinking water, and non-occupational non-dietary exposure is possible. The number average MW of 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, is greater than 10,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, 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. Therefore a tolerance is not necessary to protect the public health.

D. Cumulative Effects

Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, "available information" concerning the cumulative effects of a particular chemical's residues and "other substances that have a common mechanism of toxicity", must be considered. At this time, available data to determine whether 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, has a common mechanism of toxicity with other substances is not available. Since 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, meets the definition of a low concern polymer, 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, is not expected to show any cumulative effects.

E. Safety Determination

     1.   U.S. Population: Based on the conformance to the criteria used to identify a low risk polymer, there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1.

     2.   Infants and children: Section 408 of the 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 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, based on the polymer meeting the definition of a low risk polymer under 40 CFR 723.250 a safety factor analysis to assess the risk is not necessary. For the same reasons the additional tenfold safety factor is unnecessary.

F. International Tolerances

There are no CODEX maximum residue limits established for 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, in or on crops or commodities at this time.

G. Other Considerations

Endocrine Disruptors: There is no available evidence that 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, CASRN. 35297-61-1, is an endocrine disruptor.
