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-10834]

EPA has received a pesticide petition ([IN-10834]) 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 180.960 to establish an exemption from the requirement of a tolerance for polyamide 

ester 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
2

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. [Polyamide Ester 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.
3

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
4

[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.]