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**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 re place 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 Turn pi** **ke 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**  **- am** **inoethyl) -**  **, 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 requ**  **ired 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) .** 2 3. Magnitude of residues. [ **NA -** **Remove based on fact this information is generally**  **not required when all criteria for polymer exemption per 40 CFR 723.25**  **0 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 -**  **am inoethyl)**  **- , polymer**  **with 2,4 -**  **diisocyanato -**  **1 -**  **methylbenzene, with**  **number average molecular weight**  **greater than 10,000 d altons**  **,** CAS Reg. No. **35297 -**  **61 -**  **1 ,**  conforms to the definition of a poly

mer given in 40 CFR 723 .250 (b) and meets the criteria that are use d to identify

low risk poly

mers under the TSCA Poly mer Exemption Guidelines. **1,2 -** **Ethanediamine, N 1**  **- (2**  **- am** **inoethyl) -**  **, polymer with 2,4 -**  **diisocyanato -**  **1 -**  **methylbenzene, CASRN. 35297 -**  **61 -**  **1** is a pol ymer as defined b y 40 CFR 723.250(b). It is composed of at least 6 monomer units. In addition, **1,2 -**  **Ethanediamine, N1 -**  **(2 -**  **am inoethyl)**  **- , polymer with**  **2,4 -**  **diisocyanato -**  **1 -**  **methylbenzene** , **CASRN. 35297 -**  **61 -**  **1 ,**  consists of a simple weight majority of the poly mer molecules. The monomer sequences form uninterrupted strings in the poly mer and distribution of the molecular weight of the poly mer is due largely to the number of monomer units in the individual molecules.

The poly mer meets the following 7 criteria under 40 CFR 723.250 : 1. The pol ym er **1,2 -** **Ethanediamine, N1**  **- (2**  **- am** **inoethyl) -**  **, polymer**  **with 2,4**  **- diisocyanato**  **- 1**  **- methylbenzene,**  **CASRN. 35297**  **- 61**  **- 1**  **,** is not a cationic poly mer nor is it reasonabl y anticipated to become a cationic poly mer in a natural aquatic environment. The pol ym er 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 pol ym er **1,2 -** **Ethanediamine, N1**  **- (2**  **- am** **inoethyl) -**  **, polymer**  **with 2,4**  **- diisocyanato**  **- 1**  **- methylbenzene,**  **CASRN. 35297** **- 61**  **- 1**  **,** contain s Carbon, Nitrogen, Hydrogen, and Oxygen as an integral part of its composition**.** 3. The poly

mer 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 pol ym er is neither designed nor can it be reasonabl y anticipated to substantially

degrade, decompose, or depol ym erize. For the purposes of this section, degradation, decomposition , or depol ymerization mean s those types of chemical change that convert a poly

meric substance into simpler, smaller substances, through processes3

including but not limited to oxidation, hydrolysis, attack by s olvents, heat, light, or microbial action. The poly mer 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 poly

mer is not a water- absorbing pol ym er, and has a number average molecular weight greater than or equal to 10,000 daltons. Additionally, the pol ym er, **1,2 -** **Ethanediamine, N1 -**  **(2 -**  **am inoethyl)**  **- , 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). Specificall y, option (2) : The poly mer 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 -**  **am inoethyl)**  **- , 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, CAS**  **RN. 35297** **- 61**  **- 1**  **,** is greater than 1 0 ,000 daltons. Generally, a pol ym er of this size would be poorl y absorbed through the intact gastrointestinal tract or through intact human skin. Since **1,2 -** **Ethanediamine, N1**  **- (2**  **- am** **inoethyl) -**  **, polymer**  **with 2,4**  **- diisocyanato**  **- 1**  **- methylbenzene,**  **CASRN. 35297** **- 61**  **- 1**  **,** conforms to the criteria that identify a l ow risk poly

mer, there are no concerns for risks associated with any p otential exposure scenarios that are reasonably f oreseeable. 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 parti cular 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**  **- am** **inoethyl) -**  **, polymer**  **wit h**  **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 pol ymer, **1,2 -** **Ethanediamine, N1 -**  **(2 -**  **am inoethyl)**  **- ,** 4

**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 l ow risk poly mer, 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 -**  **am inoethyl)**  **- ,**  **polymer with**  **2,4 -**  **diisocyanato -**  **1 -**  **methylbenzene, CASRN. 35297 -**  **61 -**  **1**

. 2. In fants and children: Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety f or 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 poly mer meeting the definition of a low risk polymer under 40 CFR 723.250 a safety factor anal ys is 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 fo r **1,2 -** **Ethanediamine, N1**  **- (2**  **- am** **inoethyl) -**  **, 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.