Document ID: EPA-HQ-OPP-2015-0465-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-08-26T04:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: [PV Shah, Branch Chief Inert Assessment Branch (IAB) 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:

[Croda, Inc.]

[IN-10830]

	EPA has received a pesticide petition ([IN-10830]) from [Croda, Inc., 315 Cherry Lane, New Castle DE, 19720] 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 Polyester Polyol Polymers having a number-average molecular weight greater than 10,000 Daltons, used as dispersants, emulsifiers, surfactants, and related adjuvants of surfactants in food use pesticide formulations in or on raw agricultural commodities. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FFDCA; 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 to include the following Chemical Abstracts Services Registry numbers:

                                  CAS NO.'S
                                   CAS. NAME
                                  678991-29-2
Fatty acids, C18-unsatd., dimers, hydrodenated, polymers with
       Ethylenediamine, neopentyl glycol and stearyl alcohol
                                  363162-42-9
Fatty acids, C18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol
                                  951153-32-5
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol
                                 1699751-19-3
Fatty acids, C18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine
                                 1699751-23-9
Fatty acids, C18-unsatd., dimers, polymers with cetyl alc., neopentyl glycol and trimethylenediamine
                                 1699751-24-0
Fatty acids, C18-unsatd., dimers, polymers hexamethylenediamine and stearyl alc.
                                 1699751-25-1
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with cetyl alc. and ethylenediamine 
                                 1699751-28-4
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alc. and trimethylenediamine 
                                 1699751-29-5
Fatty acids, C18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine 
                                 1699751-31-9
 Fatty acids, C18-unsatd., dimers, polymers with docosanoic acid and sorbitol
                                 1685271-04-8
Fatty acids, C18-unsatd., dimers, hydrogenated,  polymers with docosanol, hexamethylenediamine and neopentyl glycol

   A. Residue Chemistry

1. Plant metabolism. [NA-Remove based on the fact that this information is not required for the establishment of a tolerance exemption.]

2. Analytical method. [NA-Remove based on the fact that this information is not required for the establishment of a tolerance exemption.]

3. Magnitude of residues. [NA-Remove based on the fact that this information is not required for the establishment of a tolerance exemption.]
	

   B. Toxicological Profile

   1. Acute toxicity.  [Polyester Polyol Polymers conform to the definition of a polymer given in 40 CFR 723.250(b) and meets the following 40 CFR 723.250 criteria that are used to identify low-risk polymers.
   
1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.
3. The polymer 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).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MWn) greater than or equal to 10,000 Daltons.
7. The minimum number average molecular weight of all the polymers listed above is greater 1,000 Daltons.  The oligomer content is less than 10% (w/w) below a number average molecular weight of 500 and less than 25 % (w/w) below a number average molecular weight of 1,000.

	2. Genotoxicty. [NA-Remove based on the fact that this polymer meets the 40
CFR 723.250 criteria that are used to identify low-risk polymers.]

	3. Reproductive and developmental toxicity. [NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]
 

	4. Subchronic toxicity. [NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	5. Chronic toxicity. [[NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	6. Animal Metabolism. .[NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	7. Metabolite toxicity. [NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	8. Endocrine Disruption. [Not expected based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	C. Aggregate Exposure

	1. Dietary exposure. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

      i. Food. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

      ii. Drinking water. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

      2. Non-dietary exposure. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

D. Cumulative Effects

      	[This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

E. Safety Determination

      1. U.S. population. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]
      
      2. Infants and children. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]
      

F. International Tolerances

      [There are no known international tolerances for this polymer.]