Update March 17 – Polymer Mn Corrections

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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

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 
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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.

1. Not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a 

natural aquatic environment.

a. Vinyl acetate, ethylene and glycidyl 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 polymer is composed of a hydrocarbon backbone.

b. The polymer contains carbon, hydrogen, oxygen, silicon and sulfur.

3. 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).

a. The polymer is composed of hydrocarbon backbone, with none of the excluded 

elements

4. Does not degrade, decompose, or depolymerize in manufacture or use

a. Typical decomposition temperature of Vinyl Acetate polymers is >300C (TGA)

b. The product does not change during manufacture or use.

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.

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. 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.

7. Does not contain certain perfluoroalkyl moieties

a. A review of the ingredient list shows no fluorinated components

8. 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).
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a. 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
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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.
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