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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: PV Shah- Inert Ingredients branch

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:

Evonik Corporation

IN-10754

EPA has received a pesticide petition IN-10754 from Evonik Corporation, 299 

Jefferson Rd, Parsippany NJ 07054 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.

(Options (pick one)

2. to establish an exemption from the requirement of a tolerance for a low risk 

polymer.

2-propanoic acid, 2-methyl-,2-methylpropyl ester, homopolymer in or on the 

raw agricultural commodity food crops. 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.

2. Analytical method. [Insert text.]

3. Magnitude of residues. [Insert text.]

B. Toxicological Profile
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1. Acute toxicity. [Practically non-toxic as the substance is a non-bioavailable 

polymer; LD50 rat, oral > 5200 mg/kg; LD50 rat, dermal > 9000 mg/kg 

(analogy; test item was a copolymer containing methyl methacrylate and 

acrylates; source: literature*]

2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, homopolymer with an 

average molecular

weight 158.000 Daltons conforms to the definition of a polymer given in 40

CFR 723.250 and meets the criteria that are used to identify low risk 

polymers.

The following criteria are met:

1. Not a cationic polymer nor is it reasonably anticipated to become a

cationic polymer in a natural aquatic environment.

a. Isobutyl methacrylate [CAS 97-86-9] is a neutral monomer.

2. Contains as an integral part of its composition at least two of the atomic

elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.

a. The polymer is composed of a hydrocarbon backbone and contains

carbon, hydrogen and oxygen.

3. 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).

a. The polymer is composed of hydrocarbon backbone with none of the

excluded elements 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.

a. The product does not change during manufacture or use.

5. The polymer is manufactured or imported from monomers and/or reactants

that are already included on the TSCA Chemical Substance Inventory or

manufactured under an applicable TSCA section 5 exemption.

a. Isobutyl methacrylate [CAS 97-86-9] is listed on TSCA.

6. Is not water absorbing with a number average molecular weight greater than or

equal to 10.000

Daltons.

a. The average molecular weight of the polymer is158.000 Daltons. Due to

isobutyl methacrylate

[CAS 97-86-9] is a neutral monomer its polymer is insoluble in water.

7. The polymer does not contain, as an integral part of its composition, 

except as impurities, one or more of the following perfluoroalkyl moieties

consisting of a CF3- or longer chain length: a. Perfluoroalkyl sulfonates

(PFAS), b. Perfluoroalkyl carboxylates (PFAC),
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c. Fluorotelomers, d. Perfluoroalkyl moieties that are covalently bound to either

a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the

polymer molecule.

a. The polymer is 100% 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, 

homopolymer.

b. No perfluoroalkyl components are used in the manufacturing process of the

polymer.

8. The polymer must meet one of the exemption criteria specified in 40 CFR 

723.250(e):

a. The polymer meets the criteria in 40 CFR 723.250(e)(2) by having a number

average molecular weight greater than 10,000 Dalton, less than 2% oligomeric

material below MW 500 and less than

5% oligomeric material below MW 1,000.

As stated above, 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester,

homopolymer meets all criteria for a polymer to be considered low risk 

under 40 CFR 723.250. Based on it conformance to the criteria in this

unit, no mammalian toxicity is anticipated from dietary, inhalation, or 

dermal exposure to 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester,

homopolymer.

2. Genotoxicty. [Practically non-toxic (see above); Two Ames-Tests were 

negative kg (analogy; test copolymer containing methyl methacrylate 

and acrylates; source: literature*]

3. Reproductive and developmental toxicity. [Practically non-toxic as the 

substance is a non-bioavailable polymer]

4. Subchronic toxicity. [Practically non-toxic (see above)]

5. Chronic toxicity. [Practically non-toxic (see above)]

6. Animal metabolism. [Not bioavailable, no metabolism expected]

7. Metabolite toxicology. [No metabolites expected to be formed]

8. Endocrine disruption. [Not expected as the substance is a non-bioavailable 

polymer]

*Reference: Cosmetic Ingredient Review Expert Panel, Final Report on the Safety 

Assessment of Acrylates Copolymer and 33 Related Ingredients. Int J Toxicol 3 

(21): 1-50 (2002)

C. Aggregate Exposure

1. Dietary exposure. [Insert text.]
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i. Food. [Insert text.]

ii. Drinking water. [Insert text.]

2. Non-dietary exposure. [Insert text.]

D. Cumulative Effects

[Insert text.]

E. Safety Determination

1. U.S. population. [Insert text.]

2. Infants and children. [Insert text.]

F. International Tolerances

[Insert text.]