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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: William Cutchin (703)-305-7990

TEMPLATE:

Celanese, Ltd.

IN-10689

EPA has received a pesticide petition (IN-10689) from Celanese Ltd, 222 W Las 

Colinas Blvd, Suite 900N, Irving, TX 75039 requesting, 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 acetic acid 

ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate 

(1:1) minimum number average molecular weight (in amu), 16,200 (CASRN 913187-38-

9) 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

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.

1. Plant metabolism. NA.

2. Analytical method. NA.

3. Magnitude of residues. NA.

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.
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1. Acute toxicity. Acetic acid ethenyl ester, polymer with ethane, 

ethenyltriethoxysilane and sodium ethenesulfonate (1:1), minimum average 

molecular weight (in amu) 16,200 conforms to the definition of a polymer given 

in 40 CFR 723(1)) 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:

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 Silquest (TMVS) 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.

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 four 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 >98% of the monomers being vinyl acetate and ethylene, no water 

absorption is seen. Additionally, the number average molecular weight is 

16,200 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) or 40 CFR 

723.250(e)(3). 

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% 
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oligomeric material below MW 500 and less than 5% oligomeric material below 

MW 1,000.

As stated above, acetic acid ethenyl ester, polymer with ethane,

ethenyltriethoxysilane and sodium ethenesulfonate (1:1) 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).

2. Genotoxicty. NA.

3. Reproductive and developmental toxicity. NA.

4. Subchronic toxicity. NA.

5. Chronic toxicity. NA.

6. Animal metabolism. NA.

7. Metabolite toxicology. NA.

8. Endocrine disruption. NA.

C. Aggregate Exposure

For the purposes of assessing potential exposure under this exemption, acetic acid ethenyl 

ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1) 

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 acetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane and 

sodium ethenesulfonate (1:1) is 16,200 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.

i. Food. NA.

ii. Drinking water. NA.

2. Non-dietary exposure. NA.

D. Cumulative Effects
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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 acetic acid 

ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate 

(1:1) 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, acetic acid ethenyl ester, polymer with ethane, 

ethenyltriethoxysilane and sodium ethenesulfonate (1:1) should not be assumed to have a 

common mechanism of toxicity with other substances.

E. Safety Determination

1. U.S. population. NA.

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 acetic acid ethenyl ester, polymer with 

ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1), 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 Ltd is not aware of any country requiring a tolerance for acetic acid 

ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate 

(1:1) nor have any CODEX Maximum Residue Levels (MRL's) been established for any 

food crops at this time..