EPA REGISTRATION DIVISION CO MPANY 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 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:

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 pestic ides applied to growing crops or to raw

commodities after harvest . EPA has determined that th e petition contains data or information regarding the elements set fort h 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 th eir compliance with the Low Risk Polymer criteria per 40 CFR 723.250. Therefore, an analytical method to determine residues in raw agricultural co mmodities has not been proposed. No residue chemistry data or environmental fate data are presented in the petition as the Agency does not genera lly require some or a ll of the listed stud ies to rule on the exemption from the requirement of a toleran ce for a low risk poly mer inert ingredient.2

B . Toxicological Profile

1. Acute toxicity. The Agency has estab lished a set of criteri a 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 ri sk. These criteria (d escribed in 40 CFR 723.250 ) identify polymers th at are relatively unreactive and stable compared to other chemical substances as well as polymers that typically are no t readily absorbed. Croda believes that alkoxylate d glycerides conform to the de finition of a polymer given
in 40 CFR 723.250 and m eet 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 di etary, inhalation or dermal exposure to emulsion polymers and that emulsion poly mers will present minimal or no risk.

1 2. It contains as an integr al 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 Chemic al 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 mol ecular weights greater than 400 are generally not readily absorbed through the intact skin, and substances with molecular weights greater than 1,000 are ge nerally 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 fo r risks associated with toxicity.3

6. Animal metabolism. [NA-Remove]

7. Metabolite toxicology

. [NA-Remove]

8. Endocrine disruption

. There is no eviden ce 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 cu mulative risk for erally

GI)

forming to th e 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. Substa nces 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 re adily 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 e liciting a toxic response.

D

alkoxylated glycerides. Polymers with mole cular weights greater than 400 gen are not absorbed through the intact skin , and substances with molecular weights greater than 1,000 generally a re not absorbed thro ugh the intact gast rointestinal ( tract. Chemicals not absorbed through the sk in or GI tract generally are incapable of eliciting a toxic response. Th erefore, there is no reasonab le expectation of increased risk due to cumulative exposure. Based on this polymer con

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

concerns for risks associated with cumulative effects.

E4

F

. International Tolerances

[NA-Remove]