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EPA REGISTRATION DIVISION CO MPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [PV Shah, (703) 308-1846]

INSTRUCTIONS: Please utilize this outline in p reparing the pesticide petition. In

cases where the outline element does not apply, please insert “NA-Remove” and

maintain the outline. Please do not chan ge the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green , i.e., “ [insert company name] ,” with the information specific to your action.

TEMPLATE:

[Rhodia, Inc.]

[0E7692]

EPA has received a pesticide petition ([0E7692]) from [Rhodia, Inc. c/o SciReg, Inc.], [12733 Director’s Loop, Woodbridge, VA 22192] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosme tic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

1. by establishing a tolerance for residues of

2. to establish an exemption from the requirement of a tolerance for

[castor oil, ethoxylated, oleate (CAS No. 220037-02-5) with a minimum number average molecular weight (i n amu) of 1,200 under 40 CFR 180.960 when

used as an emulsifier and surfac tant 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

1. Plant metabolism.

2. Analytical method. [Rhodia is requesting that cast or oil, ethoxylated, oleate, with a minimum number average molecular weight (in amu) of 1,200 be exempt from the requirement of a tole rance based upon the definiti on of a low-risk polymer2

under 40 CFR 723.250. Therefore, Rhodia believe s that an analytical method to determine residues in treated crops is not relevant.]

3. Magnitude of residues. [Rhodia is requesting that castor oil, ethoxylated, oleate, with a minimum number average molecular weight (in amu) of 1,200 be exempt from the requirement of a tolerance based upon the definition of a low-risk polymer under 40 CFR 723.250. Therefore, Rhodia believes that data on the magnitude of residues in trea ted crops is not relevant.]

B. Toxicological Profile

1. Acute toxicity. [No toxicological data is subm itted with, or referenced in, this tolerance exemption petition because ca stor oil, ethoxylated, oleate, meets the definition of a low risk polymer under 40 CFR 723.250.

1. Castor oil, ethoxylated, oleate is a polymer molecule as defined by 40 CFR 723.250(b). That is, it contains a sequence of at least 3 monomer units which are covalently bound to at least one other monomer unit or other reactant.

2. Castor oil, ethoxylated, oleate consis ts of a number average molecular weight greater than 1,000 and less than 10,000 dalton s. Its oligomer content is less than 10 percent below molecular weight 500 and less than 25 percent below molecular weight 1,000.

3. Castor oil, ethoxylated, oleate is not a cationic polymer and is not anticipated to become a cationic polymer in a natura l aquatic environment. As an example, there is no amino functionality presen t which might under certain circumstances become a positively charged ammonium ion. The only functional groups present in the subject polymer are carboxylic ester a nd aliphatic ether linkages which will not become positively charged.

4. Castor oil, ethoxylated, oleate has the properties of a nonionic surfactant and only contains the elements carbon, hydr ogen, and oxygen; therefore, it meets the criteria for elemental composition. No compounds which contain prohibited

elements are used in the ma nufacture of this polymer.

5. Castor oil ethoxylates and their deri vatives are not readily biodegradable. Castor oil, ethoxylated, oleate is not desi gned to substantially degrade, decompose, or depolymerize in the environment.

6. All monomers and reactants which are us ed in the production of castor oil, ethoxylated, oleate are listed on th e TSCA Chemical Substance Inventory.

7. Castor oil, ethoxylated, oleate is not a water-absorbing polymer with a number average molecular weight above 10,000 daltons, but is dispersible in water3

due to its properties as a nonionic surfactant.

8. Castor oil, ethoxylated, oleate contains no reactive functional groups that fail to meet the low-risk polymer ex emption criteria under 40 CFR 723.250(e).]

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

1. Dietary exposure. [The physical and chemical char acteristics of castor oil, ethoxylated, oleate lead to the conclusion that there is a reasonable certainty of no harm from exposure to the polymer from food or drinking water.]

i. Food. [NA-Remove]

ii. Drinking water. [NA-Remove]

2. Non-dietary exposure

. [The physical and chemical characteristics of castor oil, ethoxylated, oleate lead to the conclu sion that there is a reasonable certainty of no harm from exposure to the polymer through non-dietary means.]

D. Cumulative Effects

[Castor oil, ethoxylated, oleate is a lo w-risk polymer. There is no information at this time to suggest that any toxic effects produced by this inert ingredient would be cumulative with any other chemical.]

E. Safety Determination

1. U.S. population. [Castor oil, ethoxylated, olea te meets all the criteria for qualification of a low-risk polymer und er 40 CFR 723.250. Adverse effects on the U.S. population are not expected from the us e of this inert ing redient in pesticide formulations.]4

2. Infants and children

. [Castor oil, ethoxylated, olea te is a low-risk polymer. No adverse effects are expected from use of this inert ingredient in pesticide formulations. Based on the physical and chem ical properties of the molecule, there

is no reason to believe that infants and ch ildren will be disproportionately at risk.]

F. International Tolerances

[Castor oil, ethoxylated, oleate, wi th a minimum number average molecular weight (in amu) of 2,000, is currently exem pt from the requirement of a tolerance (40 CFR 180.960).]