EPA REGISTRATION DIVISION COMPANY CORRECTED NOTICE OF FILING

FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [P.V. Shah, 703-308-1846]

INSTRUCTIONS: Please utilize this outline in prep aring 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., “ [Croda Inc.] ,” with the information specific to your action

[Croda Inc.]

[Insert Petition Number]

EPA has received a pesticide petition ([Insert Petition Number]) from [Croda Inc., EPA Company Number 86095], [315 Cherry Lane New Castle, DE 19720] proposing, pursuant to section 408(d) of the Fe deral Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to establish an exemption from the requirement of a tolerance for Polymerized Fatty Acid Esters with Aminoalcohol Al koxylates (PFAEAA) under 40 CFR §180.910 preand post-harvest uses and 40 CF R §180.930 animal uses, including:

CAS RN’s supported under the followin g tolerance exemption descriptor:

“Fatty acids, unsaturated, dimers a nd/or trimers, esters with [alpha] - alkylaminoalkyl -[o mega]- hydroxy poly (oxye thylene) or [alpha] - alkylaminoalkyl -[o mega]- hydroxy poly (oxyethylene) poly (oxypropylene) copolymers where the poly (oxyethylene) content is 10-30 moles and the poly (oxypropylene) content is 0-20 moles, the resulting alkoxylated aminoalcohol

esters are derived and limited to 2- (N,N Dimethyl) aminoethanol, 2-(N,NDimethyl) aminopropanol, 2- (N,N-Die thyl) aminoethanol, 2-(N,N-Diethyl) aminopropanol, 2-Hydroxyethylmorpho line, and 2-Hydroxyethylpiperidine

and have a minimum molecular weight (in amu) of 1,200.”]

PFAEAA

CAS RN Chemical Name
1173188-38-9 Dimethylaminoethanol, et hoxylated, reaction products with fatty acid dimers 1173188-42-5 Dimethylaminoethanol, et hoxylated, propoxylated, reaction products with fatty acid dimmers 1173188-72-1 Diethylaminoethanol, ethoxylated, reaction product with fatty

acid dimers 1173188-75-4 Diethylaminoethanol, et hoxylated, propoxylated, reaction products with fatty acid dimersCAS RN Chemical Name
1173188-49-2 Dimethylaminoethanol, et hoxylated, reaction products with fatty acid trimers

1173189-17-7 Dimeth y laminoethanol, ethox y lated, propox y lated, reaction pro d with fatty acid trimers 1173188-81-2 Diethylaminoethanol, ethoxylated, reaction products with fatty acid trimers 1173188-83-4 Diethylaminoethanol, et hoxylated, propoxylated, reaction products with fatty acid trimers 1173189-00-8 Hydroxyethylmorpholine, ethoxyl ated, reaction products with fatty acid dimers 1173189-06-4 Hydroxyethylmorpholine, et hoxylated, propoxylated, reaction products with fatty acid dimers 1173189-20-2 Hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid dimers 1173189-22-4 Hydroxyethylpiperidine, eth oxylated, propoxylated, reaction products with fatty acid dimers 1173189-09-7 Hydroxyethylmorpholine, ethoxylated, reaction products with fatty acid trimers 1173189-17-7 Hydroxyethylmorpholine, et hoxylated, propoxylated, reaction products with fatty acid trimers 1173189-25-7 Hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid trimers 1173189-28-0 Hydroxyethylpiperidine, eth oxylated, propoxylated, reaction products with fatty acid trimers

The PFAEAA surfactants can be generica lly described as polyethylene or polyethylene/polypropylene glyc ol polymers consisting of a dialkylaminoalcohol end group molecule that has undergone polymerization with either 10-30 polyoxyethylene units or 10- 30 polyoxyethylene units followed by 0-20 polyoxypropylene units and esterified with cross linked fatty acids containing 2 or 3 fatty acid residues

.

Croda Inc. has provided information that confirm that the PFAEAA pesticide inert surfactants supported by way of this petition meet the criteria for low risk polymers as specified in 40 CFR §723.250(b) and that the data included within the petition also address the exclusion criteria cited as applicable under 40 CFR 723.250 (d)(1) and (e)(1)(ii)(C).

The molecular weight and polymer stability were determined as follows:

• Conventional gel permeation chromatography using both polystyrene based and polyethylene glycol calibrations, confir med that an example PFAEAA polymer, CAS Number 1173188-81-2, an the oligomer content less than 10% (w/w) below a NumberAverage Molecular Weight of 500 and le ss than 25% (w/w) below a Number-Average Molecular Weight of 1,000.• MALDI mass spectrum for two manufactu ring batches of CAS Number 1173188-81-2

confirmed that the distribution and molecular weight range of the polyethoxylate esters that comprise the polymeric mixture ranged from 759 to 3017 mass units.

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 t he sufficiency of the submitted data at this tim e or whether the data supports granting of the petition. Additional data may be need ed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. [Not applicable/Not required for the establishment of a tolerance exemption for inert ingredients.]

2. Analytical method. [Not applicable/Not required for the establishment of a tolerance exemption for inert ingredients.]

3. Magnitude of residues. [There is no specific crop res idue information available for

PFAEAA surfactnats and this information is typically not available nor required for the establishment of a tolerance exemption for polymeric inert ingredients.]

B. Toxicological Profile



### 1. Acute toxicity. [ Human exposure from the use of PFAEAA as pesticide inert ingredients will primarily occur via the oral route through the consumption of food or drinking water. PFAEAA pesticide in ert ingredients are polyethylene or polyethylene/polypropylene glycol polymers that may include compounds with molecular weights exceeding 3,500 amu. As noted in 40 CFR §723.250(b), substances with molecular weights greater 400 are not absorbed through the intact skin and substances with molecular weights greater than 1,000 are not absorbed through the intact gastrointestinal (GI) tract.

Polymeric PFAEAA pesticide inert ingredie nts are also not volatile and therefore, post-application inhalation exposure is unl ikely. An example test compound, CAS 1173188-81-2 showed low acute toxicity (limit dose LD 50 > 2,000 mg/kg body weight by the oral route of exposure. Additi onally, skin and eye irritation were not reported in animal laboratory studies.]

2. Genotoxicity. [CAS 1173188-81-2 was not mu tagenic in bacterial in vitro cell systems.]

3. Reproductive and developmental toxicity. [ Testing was not conducted because substances with molecular weights greater th an 1,000 are not absorbed through the intact gastrointestinal (GI) tract. ]

4. Subchronic toxicity. [ Testing was not conducted because substances with molecular weights greater than 1,000 are no t absorbed through the intact gastrointestinal (GI) tract. ]5. Chronic toxicity [ Testing was not conducted because substances with molecular weights greater than 1,000 are no t absorbed through the intact gastrointestinal (GI) tract. ]

6. Animal metabolism. [PFAEAA metabolism is unlikel y because substances with molecular weights greater than 400 are no t absorbed through the intact skin and substances with molecular weights greater th an 1,000 are not absorbed through the intact gastrointestinal (GI) tract or skin. ]

7. Metabolite toxicology

. [No metabolites of toxicological concern are expected based

on the fact that substances with molecula r weights greater than 400 are not absorbed through the intact skin and substances with molecular weights greater than 1,000 are not absorbed through the intact GI tract or skin ; therefore, animal metabolism is unlikely to occur.]

8. Endocrine disruption

. [ The PFAEAA surfactants are polyethylene polyethylene/polypropylene glycol polymers do not belong to a class of chemicals known or suspected of having adverse effects on the estrogen receptor or endocrine system.]

C. Aggregate Exposure

Dietary exposure. [Chemicals not absorbed by ingest ion through the GI tract cannot be distributed or metabolized by organisms. Theref ore, it is not necessary to conduct a dietary exposure evaluation or a related FQPA aggre gate and cumulative risk assessment for the PFAEAA pesticide inert ingredient surfactants.]

E. Safety Determination [Croda Inc. has provided relevant informatio n to confirm that the PFAEAA surfactants

can meet the definition of low risk polymers as specified in 40 CFR §723.250(b) and that

the data address the exclusion criteria cite d as applicable under 40 CFR 723.250 (d)(1) and (e)(1)(ii)(C).

• As noted in 40 CFR §723.250 (b), substances with molecular weights greater than 400 are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 are generally not absorbed through the intact GI tract.

• Chemicals not absorbed by ingestion throug h the GI tract cannot be distributed or metabolized within organisms. Therefore, it is not necessary to conduct a dietary exposure evaluation or a related FQPA agg regate and cumulative risk assessment.

• The EU Technical Guidance Document (ECB , 2003) contains information relating potential dermal absorption to molecular we ight and specifies that molecular weight of less than 100 favors dermal absorption whereas at a molecular weight greater than 500, the molecule may be too larg e for dermal absorption to occur.

• The average molecular weights of PFA EAA surfactants exceed 1000 Daltons and thus qualify PFAEAA surfactant s as polymeric substances.• The PFAEAA polymers contain a substant ial portion of cross-linked fatty acid

residues that are resistant to chem ical and biological degradation.

• Steric protection, as a result of polym eric/molecular folding and intra-molecular association, also prevents ester link age hydrolysis and the PFAEAA end group tertiary amine and acid functionalitie s from undergoing a dditional chemical

reactions.

• HPLC analysis of duplicate manufacturi ng batches of CAS 1173188-81-2 indicated that there is < 0.5 ppm of formaldehyde. T hus, the polyethyelene glycol polymeric units are not considered susceptible to oxidative degradation (due to ester hydrolysis).]

F. International Tolerances

[There are no known international tolera nces for Polymerized Fatty Acid Esters with Aminoalcohol Alkoxylates (PFA EAA) pesticide inert surfactants. ]