Update March 17  -  Polymer Mn Corrections

Document 3	


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

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-methyl-, 2-oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1)  (CAS  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 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 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 polymer that should present minimal or no risk.

Requirements for data on residue chemistry are not applicable to a request to establish an exemption from the requirement of a tolerance, based on conformance to specific criteria that identify categories of polymer that should present minimal or no risk.

2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1)  (CAS  518057-54-0) minimum average molecular weight (in amu) 20,233 conforms to the definition of a polymer given in 40 CFR 723(b) and meets the criteria that are used to identify low risk polymers.  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.
 Not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
 Vinyl acetate, ethylene and glycidyl methacrylate and trimethoxyvinyl silane are neutral monomers
 Sodium vinyl sulfonate is anionic
            
 Contains as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
 The polymer is composed of a hydrocarbon backbone.
 The polymer contains carbon, hydrogen, oxygen, silicon and sulfur.
            
 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).
 The polymer is composed of hydrocarbon backbone, with none of the excluded elements
            
 Does not degrade, decompose, or depolymerize in manufacture or use
 Typical decomposition temperature of Vinyl Acetate polymers is >300C (TGA)
 The product does not change during manufacture or use.
            
 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.
 The monomers are all on TSCA
            
 Is not water absorbing with a number average molecular weight greater than or equal to 10,000 Daltons.
 With >95% of the monomers being vinyl acetate and ethylene, no water absorption is seen.  Additionally, the number average molecular weight is 20,233 Daltons.
      
 Does not contain certain perfluoroalkyl moieties
 A review of the ingredient list shows no fluorinated components
            
 The polymer meets criteria specified in 40 CFR 723.250(e)(1),  40 CFR 723.250(e)(2), or 40 CFR 723.250(e)(3).
 The polymer 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 material 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-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

C. Aggregate Exposure 
	For the purposes of assessing potential exposure under this exemption, 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1)  (CAS  518057-54-0) could be considered to 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 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1)  (CAS  518057-54-0)  is 20,233 Daltons.  Generally, a polymer of this size would be poorly absorbed through the intact gastrointenstinal tract or through intact human skin.  Since Acetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane 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

	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 whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency 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-methyl-, 2-oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1)  (CAS  518057-54-0)  has a common mechanism of toxicity with other substances. Acetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane 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 polymer should not be assumed to have a common mechanism of toxicity with 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 polymer, a safety factor analysis to assess specific risk to infants and children should not be required.  For the same reasons, the additional 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-oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1)  (CAS  518057-54-0) nor have any CODEX Maximum Residue Levels (MRL's) been established for any food crops at this time.

	




