EPA REGISTRATION DIVISION COMPANY 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 preparing 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 in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

Advanced Polymer Technology

2E8040

	EPA has received a pesticide petition (2E8040)  from Advanced Polymer Technology, 109 Conica Lane, P.O. Box 160, Harmony, PA  16037  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 Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid (CAS Reg. No. 1357486-09-9),  3,748 amu under  40 CFR 180.960 when used as an inert ingredient in pesticide formulations as a solubilizer without  limitations. 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. Advanced Polymer Technology is petitioning that Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid be exempt from the requirement of a tolerance based upon the definition of a low-risk polymer under 40 CFR 723.250.  Therefore, plant metabolism in treated crops is not relevant.


	2. Analytical method. Advanced Polymer Technology is petitioning that Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid be exempt from the requirement of a tolerance based upon the definition of a low-risk polymer under 40 CFR 723.250.  Therefore, an analytical method to determine residues on treated crops is not relevant.

	3. Magnitude of residues. Advanced Polymer Technology is petitioning that Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid be exempt from the requirement of a tolerance based upon the definition of a low-risk polymer under 40 CFR 723.250.  Therefore, magnitude of residues on treated crops is not relevant.

B. Toxicological Profile

	1. Acute toxicity.  No toxicological data is submitted with, or referenced in this tolerance exemption petition because Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid meets the definition of a low-risk polymer under 40 CFR 723.250.

1. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid 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, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid has a number average molecular weight of 20,000 and contains less than 0.1 percent oligomeric material below molecular weight 500 and 1,000 molecular weight.

3. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid is not a cationic polymer and is not anticipated to become a cationic polymer in a natural aquatic environment.

4. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid only contains the elements carbon, hydrogen, and oxygen; therefore, it meets the criteria for elemental composition.

5. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid 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).

6. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid is not designed or reasonably anticipated to substantially degrade, decompose, or depolymerize under normal use conditions.

7. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid is manufactured or imported from monomers and/or other reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemptions.

8. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid is not a water-absorbing polymer with a number average molecular weight above 10,000 Daltons.

9. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid contains no reactive functional groups that fail to meet the low-risk polymer exemption 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 characteristics of Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid  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. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid  with molecular weight in the range of 200-9500 has clearances under 21CFR 178.3750.


	ii. Drinking water. [NA-Remove]

	2. Non-dietary exposure. The physical and chemical characteristics of Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid lead to the conclusion that there is a reasonable certainty of no harm from exposure to the polymer from exposure to the polymer through non-dietary means.


D. Cumulative Effects.  Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid is a low-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, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid meets all the criteria for qualification as a low-risk polymer under 40 CFR 723.250. Adverse effects on the U.S. population are not expected from the use of this inert ingredient in pesticide formulations.


	2. Infants and children. Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid is a low-risk polymer. No adverse effects are expected from use of this inert ingredient in pesticide formulations.  Based on the physical and chemical properties of the molecule, there is no reason to believe that infants and children will be disproportionately at risk.



F. International Tolerances

	There are no known U.S. or international tolerances for Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid.

