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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

INSTRUCTIONS: Please utilize this outline in prepa ring the pesticide petition. In cases where the outline element does not apply, please insert “NA

- Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear i n green , i.e., “ [ insert

company name ] ,” with the information specific to your action.

TEMPLATE:

Celanese Ltd

I N

- 10900

EPA has received a pesticide petition ( IN

- 10900 ) from Celanese Ltd, 222 W Las

Co l inas 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 .960 to establish an exemption from the requirement of a tolerance for 2

- propenoic acid, butyl ester, polymer with ethenyl acetate a nd sodium ethenesulfonate (CAS 66573

- 43

- 1) in or on all agricultural commodities as a binder and wetting agent

.

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 c hemistry 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

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2. Analytical method. NA

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3. Magnitude of residues. NA

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B. Toxicological Profile2

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

2

- Propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate, minimum average molecular weight (in amu) of Mn = 20500, Mw =

59340 0 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 acco unts for 50% or more of the entire product. The following criteria are met:

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

p olymer in a natural aquatic environment. a. Vinyl acetate and butyl acrylate 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, oxve en, silicon, and sulfur. a. The polymer is composed of carbon, hydrogen, oxygen 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 i s composed of hydrocarbon backbone, with none of the excluded

elements 4. Does not degrade, decompose, or depolvmerize in manufacture or use a. Typical decomposition temperature of Vinyl Acetate polymers is >300C (TGA) b. The product does not change durin g 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. All of the monomers are 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 butyl acrylate, no water absorption is seen. Additionally, the number average molecular we ight is 20500

Daltons. 7. Does not contain certain perfluoroalkvl moieties a. A review of the ingredient list shows no fluorinated components 8. The polymer meets criteria specified in 40 CFR 122.250(e)(1) 40 CFR 723.250(e)(2) 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% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.3



### As stated above, 2

- propeno ic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate meets all criteria for a polymer to be considered low

risk under 40 CFR 723.350. Based on its conformance to the criteria in this unit,

no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate. Tox studies on similar polymers show mammalian toxicity of LD 50 > 5000 mg/kg

.

1. Acute toxicity. NA

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2. Genotoxict

y. NA

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3. Reproductive and developmental toxicity. NA

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4. Subchronic toxicity. NA

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5. Chronic toxicity. NA

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6. Animal metabolism. NA

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7. Metabolite toxicology

. NA

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8. Endocrine disruption

. NA

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C. Aggre gate Exposure

For the purposes of assessing potential exposure under this exemption, 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate 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 (Mn) of 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate is 20500 Daltons. Generally, a polymer of this size would be

po orly absorbed through the intact gastrointenstinal tract or through intact human skin.

Since 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate conforms to the criteria that identify a low

- risk polymer, there should be

n o 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

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i. Food. NA

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ii. Drinking water

. NA

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2. N on

- dietary exposure NA

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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 c umulative effects of a particular chemicals residues and "other substances that have a common mechanism of toxicity." Celanese Corporation does not have, at this time, available data to aid in determining whether 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate has a common mechanism of toxicity with other substances. 2

- Propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate also is not likely to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate should not be assumed to have a common mechanism of toxicity with

other substances.

E. Safety Determin ation

1. U.S. population. NA

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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 prenatal and post

- natal toxi city 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 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfon ate, 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 Corporation is not aware of any countr y requiring a tolerance for 2

- propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate nor have any CODEX Maximum Residue Levels (MRL's) been established for any food crops at this time.