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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.

I N

- 106 89

EPA has re ceived a pesticide petition ( IN

- 106 89 ) from Celanese Ltd, 222 W Las Colinas Blvd, Suite 900N, Irving, TX 75039 request ing, 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 estab lish an exemption from the requirement of a tolerance for a cetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1) minimum number average molecular weight (in amu), 1 6

, 2 00 ( 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 formulation s

.

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

Requirement s 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 confo rmance to specific criteria that identify categories of polymer that should present minimal or no risk.2

1. Acute toxicity. Acetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1), minimum average

molecular wei ght (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 pol ymeric 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 Silques t (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 hydrocarbo n 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 great er than or equal to 10.000 Daltons. a. With >98% of the monomers being vinyl acetate and ethylene, no water

abso r pti o n is seen. Additionally, the number average molecular weight is 16,200 Dalto n s.

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 723.25 0( 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 g reater than 10,000 Daltons, less than 2%3

oligomeric material below MW 500 and less than 5% oligomeric material below
MW 1,000.

As stated above, a cetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1) meets a ll 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 a cetic acid ethenyl ester, polymer with eth ane, 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, a cetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1) could be considered to be prese nt in all raw and processed agricultural commodities and drinking water, and non

- occupational non

- dietary exposure is poss ible. The number average MW of a cetic 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 th rough intact human skin.

Since a cetic 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. Diet ary exposure. NA.

i. Food. NA

.

ii. Drinking water

. NA

.

2. Non

- dietary exposure

. NA

.

D. Cumulative Effects4

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 determinin g whether a cetic 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 et henesulfonate (1:1) also is not likely to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, a cetic 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 t o the expected low toxicity of a cetic 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 t enfold safety factor is unnecessary.

F. International Tolerances

Celanese Ltd is not aware of any country requiring a tolerance for a cetic acid ethenyl ester, polymer with ethane, ethenyltriethoxysilane and sodium ethenesulfonate (1:1) nor have any CODE X Maximum Residue Levels (MRL's) been established for any food crops at this time.

.