EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [insert name and telephone number with area 

code] 

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

[Insert petition number]

 EPA has received a pesticide petition ([insert petition number]) from Croda 

Inc., 315 Cherry Lane, Wilmington, Delaware 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 

alkoxylated glycerides used to formulate pesticides applied to growing crops or to raw 

commodities after harvest. 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. [NA-Remove]

 2. Analytical method. [NA-Remove]

 3. Magnitude of residues. Croda is petitioning that alkoxylated glycerides be 

exempt from the requirement of a tolerance based upon their compliance with the Low 

Risk Polymer criteria per 40 CFR 723.250. Therefore, an analytical method to 

determine residues in raw agricultural commodities has not been proposed. No 

residue chemistry data or environmental fate data are presented in the petition as the 

Agency does not generally require some or all of the listed studies to rule on the 

exemption from the requirement of a tolerance for a low risk polymer inert ingredient.
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B. Toxicological Profile

1. Acute toxicity. The Agency has established a set of criteria which identifies 

. This polymer is not a cationic substance. 

sition the atomic elements carbon, 

n as an integral part of its composition, except as 

) . 

ed from monomers and/or other reactants 

 of the above mentioned polymer is 

 intact 

.

sess 

d 

meetin

2. Genotoxicty. [NA-Remove]

3. Reproductive and developmental toxicity. [NA-Remove] 

4. Subchronic toxicity. [NA-Remove]

5. Chronic toxicity. [NA-Remove]

categories of polymers that present low risk. These criteria (described in 40 CFR 

723.250 ) identify polymers that are relatively unreactive and stable compared to other 

chemical substances as well as polymers that typically are not readily absorbed. 

Croda believes that alkoxylated glycerides conform to the definition of a polymer given 

in 40 CFR 723.250 and meet the criteria used to identify a Low Risk Polymer. We also 

believe that based on this substance’s conformance to the above mentioned criteria, no 

mammalian toxicity is anticipated from dietary, inhalation or dermal exposure to 

emulsion polymers and that emulsion polymers will present minimal or no risk.

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2. It contains as an integral part of its compo

hydrogen, and oxygen. 

3. It does not contai

impurities, any elements other than those listed in 40 CFR 723.250(d)(2)(ii

4. This polymer is not designed or reasonably anticipated to substantially

degrade, decompose, or depolymerize. 

5. It is not manufactured or import

that are not already on the TSCA Chemical Substance Inventory or manufactured 

under an applicable TSCA Section 5 exemption. 

6. It is not a water absorbing polymer. 

7. The minimum average molecular weight

greater than 1000. Substances with molecular weights greater than 400 are 

generally not readily absorbed through the intact skin, and substances with 

molecular weights greater than 1,000 are generally not absorbed through the

gastrointestinal (GI) tract. Chemicals not absorbed through the GI tract are 

generally incapable of eliciting a toxic response. This polymer has an oligomer

content less than 10 percent below MW 500 and less than 25 percent MW 1,000

 Croda believes sufficient information was submitted in the petition to as

the hazards of alkoxylated glycerides. No toxicology data were presented in the 

petition as the Agency does not generally require some or all of the listed studies to 

rule on the exemption from the requirement of a tolerance for an inert ingredient. 

Based on these polymers conforming to the definition of a polymer an

g the criteria of a Low Risk Polymer appearing under 40 CFR 723.250, 

Croda believes there are no concerns for risks associated with toxicity.
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6. Animal metabolism. [NA-Remove]

7. Metabolite toxicology. [NA-Remove]

8. Endocrine disruption. There is no evidence that alkoxylated glycerides are 

ng information on the endocrine effects of this substance at 

. Aggregate Exposure

1. Dietary exposure. Alkoxylated glycerides with a molecular weight greater 

i. Food. [NA-Remove]

ii. Drinking water. [NA-Remove]

2. Non-dietary exposure. Alkoxylated glycerides with a molecular weight 

. Cumulative Effects

There is data to support a conclusion of negligible cumulative risk for 

erally 

GI) 

forming to the definition of a polymer and meeting 

the crit o 

. Safety Determination

1. U.S. population. [NA-Remove]

2. Infants and children. [NA-Remove]

endocrine disrupters. Substances with molecular weights greater than 400 generally 

are not absorbed through the intact skin, and substances with molecular weights 

greater than 1,000 generally are not absorbed through the intact gastrointestinal (GI) 

tract. Chemicals not absorbed through the skin or GI tract generally are incapable of 

eliciting a toxic response. 

 EPA is not requiri

this time.

C

than 1,000 daltons are not readily absorbed through the intact gastrointestinal tract 

and are considered incapable of eliciting a toxic response.

significantly greater than 400 are not readily absorbed through the intact skin and are 

considered incapable of eliciting a toxic response.

D

alkoxylated glycerides. Polymers with molecular weights greater than 400 gen

are not absorbed through the intact skin, and substances with molecular weights 

greater than 1,000 generally are not absorbed through the intact gastrointestinal (

tract. Chemicals not absorbed through the skin or GI tract generally are incapable of 

eliciting a toxic response. Therefore, there is no reasonable expectation of increased 

risk due to cumulative exposure. 

Based on this polymer con

eria of a Low Risk Polymer under 40 CFR 723.250, Croda believes there are n

concerns for risks associated with cumulative effects. 

E
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F. International Tolerances

[NA-Remove]