**Update March 17**

**– Polymer Mn Corrections** 

**Document 3**

**EPA REGISTRA** **TION DIVISION COMPA NY NOTICE OF FILING FOR**  **PESTICIDE PETITIONS PUBLISHED IN THE FEDERA L REGISTER**  **EPA Registration Division contact: P.V. Shah, (703) 308**  **- 1846**  **Celanese Ltd January**  **27, 2014**  **[Insert petition number]** EPA has received a pesticide petition **( [insert**  **petition number] )**  from **Celanese Ltd , 222 W Las Colinas Blvd, Suite 900N, Irving, TX 75039**  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 **2 -**  **propenoic acid, 2 -**  **methy l**  **- , 2**  **- oxirany**  **lmethy l este**  **r, poly mer with**  **ethene, etheny l acetate, etheny**  **ltrimethoxysilane and sodium ethenesulfonate (1:1) (CA** **S 518057 -**  **54 -**  **0)** under 40 CFR 180.960 when used as an inert ingredient as a binder and wetting agent for seed coating and adjuvant applications in pestici de 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 **NA -**  **Remove**

1. Plant metabolism. **NA -**  **Remove** 2. Analytical method. **NA -**  **Remove** 3. Magnitude of residues. **NA -**  **Remove** B. Toxicological Profile **Requirements for data on toxicological profile are not applicable to a request to establish an exemption from requirement of a tolerance, based**  **on conformance to specific criteria that identify categories of poly mer that**  **should pr esent minimal or no risk.**  **Requirements for data on residue chemistry are not applicable to a request** 2

**to establish an exemption from the requirement of a tolerance, based on conformance to specific criteria that identify categories of polymer that**  **should p resent minimal or no risk.**  **2 -**  **propenoic acid, 2 -**  **methy l**  **- , 2**  **- oxirany**  **lmethy l ester, poly**  **mer with ethene, etheny**  **l acetate, etheny ltrimethoxy** **silane and sodium ethenesulfonate (1:1) (C**  **AS 518057**  **- 54**  **- 0)**  **minimum average molecular weight (in amu) 20,233**  **conforms to the definition of a poly**  **mer given in 40 CFR 723(b) and meets the criteria that are used to identify**  **low risk poly**  **mers. The polymer contains a distribution of species of differing molecular weight, and that no**  **individual polymeric species accounts for 50% or more of the entire**  **product. The following criteria are met: (ii) Information to demonstrate that the new polymer is not specifically excluded from the**  **exemption.** 1. Not a cationic poly me r nor is it reasonably anticipated to become a cationic poly me r in a natural aquatic environment. a. Vin yl acetate, ethylene and glycidy l methacrylate and trimethoxyvinyl silane are neutral monomers b. Sodium vinyl sulfonate is anionic 2. Contains as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur. a. The poly me r is composed of a hydrocarbon backbone. b. The poly me r contains carbon, hydrogen, ox ygen, silicon and sulfur. 3. Does not contain as an integral part of its composition, except as impurities, any eleme nt other than those listed in 40 CFR 723.250(d)(2)(ii). a. The poly me r is composed of hydrocarbon backbone, with none of the excluded elem ents 4. Does not degrade, decompose, or depoly me rize in manufacture or use a. Ty pical decomposition temperature of Vinyl Acetate poly me rs is >300C (TGA) b. The product does not change during manufacture or use. 5. The poly me r is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an appli cable TSCA section 5 exemption. a. The monomers are all on TSCA 6. Is not water absorbing with a number average molecular weight greater than or equal to 10,000 Daltons

. a. Wi th > 95 % of the monomers being vinyl acetate and ethylene, no water absorption is seen. A dditionally, the number average molecular weight is 20,233 Daltons

. 7. Does not contain certain perfluoroalk yl m oieties a. A review of the ingredient list shows no fluorinated components 8. The poly me r meets criteria specified in 40 CFR 723.250(e)(1), 40 CFR 723 .250(e)(2), or 40 CFR 723.250(e)(3).3

a. The poly me r meets the criteria in 40 CFR 723.250(e)(2) by having a number average molecular weight greater than 10,000 Daltons , less than 2% oligomeric ma terial below MW 500 and less than 5% oligomeric material below MW 1,000. As stated above, 2

- propenoic acid, 2

- methyl

- , 2

- oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1) (CAS 518057

- 54

- 0) meets all criteria for a polymer to be considered low risk under 40 CFR 723.350. Based on it conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to Acetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1). 1. Acute toxicity. **NA -**  **Remove** 2. Genotoxicty. **NA -**  **Remov e**  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** C. Aggregate Exposure **For the purposes of assessing potential exposure under this exemption,**  **2 -**  **propenoic acid, 2 -**  **methy l**  **- , 2**  **- oxirany**  **lmethyl ester, poly**  **mer with ethene, etheny**  **l acetate, etheny ltrimethoxy** **silane and sodium ethenesulfonate (1:1) (CA** **S 518057 -**  **54 -**  **0) could be considered to be**  **present in all raw and processed agricultural commodities and drinking wat** **er, and non -**  **occupational non -**  **dieta ry**  **exposure is possible. The number average MW of**  **2 -**  **propenoic acid, 2 -**  **methy l**  **- , 2**  **- oxirany**  **lmethy l ester,**  **polymer with ethene, etheny l acetate, etheny**  **ltrimethoxy silane and sodium**  **ethenesulfonate (1:1) (CA S 518057**  **- 54**  **- 0)**  **is 20,233**  **Daltons . Generally**  **, a pol**  **ymer of this size would be poorly absorbed through the intact**  **gastrointenstinal tract or through intact human skin. Since A cetic acid**  **etheny l ester, poly**  **mer with ethane, etheny ltriethoxy** **silane and sodium ethenesulfonate (1:1) conforms to the criteria that**  **identify a low**  **- risk**  **polymer, there should be no concerns for risks associated with any potential exposure scenarios that are reasonably**  **foreseeable . A**  **tolerance should not be necessary**  **to protect public health.** 1. Dietary exposure. **NA -**  **Remove**4

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 FDCA requires that, when considering**  **wh ether to establish, modify, or revoke a tolerance or tolerance exemption,**  **the Ag**  **ency consider “available information” concerning the cumulative**  **effects of a particular chemical’s residues and “other substances that have a common mechanism of toxicity**  **.” Celanese Ltd does not have, at this time, available data to aid in determining whether**  **2 -**  **propenoic acid, 2 -**  **methy l**  **- , 2**  **- oxirany**  **lmethy l ester, poly**  **mer with ethene, etheny l acetate,**  **etheny ltrimethoxysilane and sodium ethenesulfonate (1:1) (CA** **S 518057 -**  **54 -**  **0) has a common mechanism of toxicity w**  **ith other substances. A cetic**  **acid etheny l ester, p**  **oly mer w**  **ith ethane, etheny ltriethoxy** **silane and sodium ethenesulfonate (1:1) also is not likely**  **to produce a toxic metabolite produced by** 

**other substances. For the purposes of this tolerance action, therefore,**  **this poly mer**  **should not be assumed to have a c ommon**  **mechanism of toxicity w ith other substances.**  E. Safety Determination 1. U.S. population. **NA -**  **Remove** 2. Infants and children

. **Section 408 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 pre**  **- natal and post**  **- natal 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 this poly**  **mer , a safety**  **factor analy sis to assess specific risk**  **to infants and children should not be required. For the same reasons, the addition**  **al tenfold safety factor is unnecessary** 

**.** F. International Tolerances **Celanese is not aware of any country requiring a tolerance for**  **2 -**  **propenoic acid, 2 -**  **methyl -**  **, 2 -**  **oxirany lmethyl ester, poly**  **mer w ith ethene,**  **etheny l acetate, etheny**  **ltrimethoxy silane and sod**  **ium ethenesulfonate (1:1) (C**  **AS 518057**  **- 54**  **- 0)**  **nor have any CODEX Maximum Residue Levels (MRL’s) been established for any**  **food crops at this time.**5