FILE NAME: company.wpt (9/1/2002)

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Commodity Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE 

(9/1/2002) 

EPA Registration Division contact: [Mark Dow (703) 305-5533] 

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[IN-10551]

Summary of Petitions 

 EPA has received a pesticide petition ([IN-10551]) from Akzo Nobel Surface 

Chemistry LLC, 909 Mueller Drive, Chattanooga, TN 37406 proposing, pursuant to section 

408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to revise an 

existing exemption from the requirement of a tolerance for modified acrylic polymers located in 

40 CFR part 180.960. EPA has determined that the petition contains data or information 

regarding the elements set forth in section 408(d)(2) of the 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. 

The existing tolerance exemption reads as follows: 

Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. 

 Residues resulting from the use of the following substances, that 

meet the definition of a polymer and the criteria specified for defining 

a low-risk polymer in 40 CFR 723.250, as an inert ingredient in a 

pesticide chemical formulation, including antimicrobial pesticide 

chemical formulations, are exempted from the requirement of a tolerance 

under FFDCA section 408, if such use is in accordance with good 

agricultural or manufacturing practices. 
------------------------------------------------------------------------ 

 Polymer CAS No. 

------------------------------------------------------------------------ 

Acrylic acid, styrene, [alpha]-methyl 89678-90-0 

 styrene copolymer, ammonium salt, minimum 

 number average molecular weight (in amu), 

 1,250 

------------------------------------------------------------------------ 

[[Page 507]] 

Acrylic acid terpolymer, partial sodium 151006-66-5 

 salt, minimum number average molecular 

 weight (in amu), 2,400 

------------------------------------------------------------------------ 

Acrylic polymers composed of one or more None 

 of the following monomers: Acrylic acid, 

 methyl acrylate, ethyl acrylate, butyl 

 acrylate, hydroxyethyl acrylate, 

 hydroxypropyl acrylate, hydroxybutyl 

 acrylate, carboxyethyl acrylate, 

 methacrylic acid, methyl methacrylate, 

 ethyl methacrylate, butyl methacrylate, 

 isobutyl methacrylate, hydroxyethyl 

 methacrylate, hydroxypropyl methacrylate, 

 hydroxybutyl methacrylate, lauryl 

 methacrylate, and stearyl methacrylate; 

 with none and/or one or more of the 

 following monomers: Acrylamide, N-methyl 

 acrylamide, N-octylacrylamide, maleic 

 anhydride, maleic acid, monoethyl 

 maleate, diethyl maleate, monooctyl 

 maleate, dioctyl maleate; and their 

 corresponding sodium potassium, ammonium, 

 isopropylamine, triethylamine, 

 monoethanolamine, and/or triethanolamine 

 salts; the resulting polymer having a 

 minimum number average molecular weight 

 (in amu), 1,200 

------------------------------------------------------------------------ 

[alpha]-alkyl (C<INF>12</INF>-C<INF>15</INF>) - [omega]- 68551-13-3 

 hydroxypoly(oxypropylene)poly(oxyethylene 

 )copolymers (where the poly(oxypropylene) 

 content is 3-60 moles and the 

 poly(oxyethylene) content is 5-80 moles), 

 the resulting ethoxylated propoxylated 

 (C<INF>12</INF>-C<INF>15</INF>) alcohols having a minimum 

 molecular weight (in amu), 1,500 

------------------------------------------------------------------------ 

Butene, homopolymer minimum number average 9003-29-6 

 molecular weight (in amu), 1,330 

------------------------------------------------------------------------ 

Butyl acrylate-vinyl acetate-acrylic acid 65405-40-5 

 copolymer, minimum number average 

 molecular weight (in amu), 18,000 
------------------------------------------------------------------------ 

Dimethylpolysiloxane minimum number 63148-62-9 

 average molecular weight (in amu), 6,800 

------------------------------------------------------------------------ 

Dimethyl silicone polymer with silica, 67762-90-7 

 minimum number average molecular weight 

 (in amu), 1,100,000 

------------------------------------------------------------------------ 

1, 2-Ethanediamine, polymer with methyl 26316-40-5 

 oxirane and oxirane, minimum number 

 average molecular weight (in amu), 1,100 

------------------------------------------------------------------------ 

Hexamethyl disilizane, reaction product 68909-20-6 

 with silica, minimum number average 

 molecular weight (in amu), 645,000 

------------------------------------------------------------------------ 

12-Hydroxystearic acid-polyethylene glycol 70142-34-6 

 copolymer, minimum number average 

 molecular weight (in amu), 3,690 

------------------------------------------------------------------------ 

Maleic anhydride-diisobutylene copolymer, 37199-81-8 

 sodium salt, minimum number average 

 molecular weight (in amu) 5,0007-18,000 

------------------------------------------------------------------------ 

Maleic anhydride-methylstyrene copolymer 60092-15-1 

 sodium salt, minimum number average 

 molecular weight (in amu), 15,000 

------------------------------------------------------------------------ 

Methacrylic acid-methyl methacrylate- 100934-04-1 

 polyethylene glycol methyl ether 

 methacrylate copolymer, minimum number 

 averge molecular weight (in amu), 3,700 

------------------------------------------------------------------------ 

Methacrylic copolymer, minimum number 63150-03-8 

 average molecular weight (in amu), 15,000 

------------------------------------------------------------------------ 

Methyl methacrylate-methacrylic acid- 119724-54-8 

 monomethoxypolyethylene glycol 

 methacrylate copolymer,) minimum number 

 average molecular weight (in amu), 2,730 

------------------------------------------------------------------------ 

Oxirane, methyl-, polymer with oxirane, 85637-75-8 

 mono[2-(2-butoxyethoxy) ethyl] ether, 

 minimum number average molecular weight 

 (in amu), 2,500 

------------------------------------------------------------------------ 

Polyethylene glycol-polyisobutenyl 68650-28-2 

 anhydride-tall oil fatty acid copolymer, 

 minimum number average molecular weight 

 (in amu), 2,960

------------------------------------------------------------------------ 

Polyoxyethylated sorbitol fatty acid None 

 esters; the sorbitol solution containing 

 up to 15% water is reacted with 20-50 

 moles of ethylene oxide and aliphatic 

 alkanoic and/or alkenoic fatty acids C<INF>8</INF> 

 through C<INF>22</INF> with minor amounts of 
 associated fatty acids; the resulting 

 polyoxyethylene sorbitol ester having a 

 minimum molecular weight (in amu), 1,300 

------------------------------------------------------------------------ 

Polyvinyl chloride, minimum number average 9002-86-2 

 molecular weight (in amu), 29,000 

------------------------------------------------------------------------ 

Polyvinyl acetate, copolymer with maleic None 

 anhydride, partially hydrolyzed, sodium 

 salt, minimum number average molecular 

 weight (in amu), 53,000 

------------------------------------------------------------------------ 

Polyvinylpyrrolidone butylated polymer, 26160-96-3 

 minimum number average molecular weight 

 (in amu), 9,500 

------------------------------------------------------------------------ 

2-Propene-1-sulfonic acid sodium salt, None 

 polymer with ethenol and ethenyl acetate, 

 number average molecular weight (in amu) 

 6,000-12,000 

------------------------------------------------------------------------ 

2-Propenoic acid, polymer with 2- 25085-02-3 

 propenamide, sodium salt, minimum number 

 average molecular weight (in amu), 18,000 

------------------------------------------------------------------------ 

2-Propenoic acid, sodium salt, polymer 25987-30-8 

 with 2-propenamide, minimum number 

 average molecular weight (in amu), 18,000 

------------------------------------------------------------------------ 

Silane, dichloromethyl- reaction product 68611-44-9 

 with silica minimum number average 

 molecular weight (in amu), 3,340,000 

------------------------------------------------------------------------ 

Styrene, copolymers with acrylic acid and/ None 

 or methacrylic acid, with none and/or one 

 or more of the following monomers: 

 Acrylamidopropyl methyl sulfonic acid, 

 methallyl sulfonic acid, 3-sulfopropyl 

 acrylate, 3-sulfopropyl methacrylate, 

 hydroxypropyl methacrylate, hydroxypropyl 

 acrylate, hydroxyethyl methacrylate, and/ 

 or hydroxyethyl acrylate; and its sodium, 

 potassium, ammonium, monoethanolamine, 

 and triethanolamine salts; the resulting 

 polymer having a minimum number average 

 molecular weight (in amu), 1,200 

------------------------------------------------------------------------ 

Styrene, 2-ethylhexyl acrylate, butyl 30795-23-4 

 acrylate copolymer, minimum number 

 average molecular weight (in amu), 4,200 

------------------------------------------------------------------------ 

Tetraethoxysilane, polymer with 104133-09-7 

 hexamethyldisiloxane, minimum number 

 average molecular weight (in amu), 6,500 

------------------------------------------------------------------------ 

[[Page 508]] 
Vinyl acetate polymer with none and/or one None 

 or more of the following monomers: 

 Ethylene, propylene, N-methyl acrylamide, 

 acrylamide, monoethyl maleate, diethyl 

 maleate, monooctyl maleate, dioctyl 

 maleate, maleic anhydride, maleic acid, 

 octyl acrylate, butyl acrylate, ethyl 

 acrylate, methyl acrylate, acrylic acid, 

 octyl methacrylate, butyl methacrylate, 

 ethyl methacrylate, methyl methacrylate, 

 methacrylic acid, carboxyethyl acrylate, 

 and diallyl phthalate; and their 

 corresponding sodium, potassium, 

 ammonium, isopropylamine, triethylamine, 

 monoethanolamine and/or triethanolamine 

 salts; the resulting polymer having a 

 minimum number average molecular weight 

 (in amu), 1,200 

------------------------------------------------------------------------ 

Vinyl alcohol-vinyl acetate copolymer, None 

 benzaldehyde-o-sodium sulfonate 

 condensate, minimum number average 

 molecular weight (in amu), 20,000 

------------------------------------------------------------------------ 

Vinyl pyrrolidone-acrylic acid copolymer, 28062-44-4 

 minimum number average molecular weight 

 (in amu), 6,000 

------------------------------------------------------------------------ 

[67 FR 36528, May 24, 2002] 

 Effective Date Note: At 67 FR 36528, May 24, 2002, Sec. 180.960 was 

added to subpart D of part 180, effective Sept. 23, 2002. 

Akzo Nobel Surface Chemistry LLC is requesting that the exemption be revised to include lauryl 

methacrylate by inserting lauryl methacrylate after hydroxyethyl acrylate and before the 

following text “and its sodium, potassium, ammonium, monoethanolamine and triethanolamine 

salts; the resulting polymer having a minimum number average molecular weight (in amu), 1200. 

This citation begins with the following: Styrene, copolymers with acrylic acid. 

A. Residue Chemistry 

 1. Plant metabolism. NA-Remove

 2. Analytical method. NA-Remove 
6 

 3. Magnitude of residues. Akzo Nobel Surface Chemistry LLC is petitioning for an 

exemption from the requirement of a tolerance based upon the polymer’s 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.

B. Toxicological Profile

 1. Acute toxicity. The Agency has established a set of criteria which identifies 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. Akzo Nobel Surface Chemistry LLC 

believes that Styrene, acrylic acid, lauryl methacrylate copolymers conform to the definition 

of a polymer given in 40 CFR 723.250 and meets 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.

1. This polymer is not a cationic substance. 

2. It contains as an integral part of its composition the atomic elements carbon, 

hydrogen, and oxygen. 

3. It does not contain as an integral part of its composition, except as 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 imported from monomers and/or other reactants 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 of the above mentioned polymer is greater 

than 10,000. 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 intact 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 2 percent below MW 500 and less than 5 percent 

MW 1,000.

 Akzo Nobel Surface Chemistry LLC believes sufficient information was submitted 

in the petition to assess the hazards of the Styrene, acrylic acid, lauryl methacrylate 
7 

copolymers. 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 and meeting the criteria of a low risk polymer under 40 CFR 

723.250, Akzo Nobel Surface Chemistry LLC believes there are no concerns for risks 

associated with toxicity.

 2. Genotoxicty. NA-Remove 

 3. Reproductive and developmental toxicity. NA-Remove 

 4. Subchronic toxicity. NA-Remove 

 5. Chronic toxicity. NA-Remove 

 6. Animal metabolism. NA-Remove

 7. Metabolite toxicology. NA-Remove

 8. Endocrine disruption. There is no evidence that the polymer is an endocrine 

disrupter. 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 requiring information on the endocrine effects of this substance at this 

time; Congress has allowed 3 years after August 3, 1996, for the Agency to implement a 

screening program with respect to endocrine effects.

C. Aggregate Exposure

 1. Dietary exposure. Some modified acrylic polymers may be used in contact with food 

as components of containers used to manufacture, process, or store food when regulated for 

such use under the Federal Food, Drug, and Cosmetic Act. Modified acrylic polymers with a 
8 

molecular weight greater than 1,000 daltons are not readily absorbed through the intact 

gastrointestinal tract and are considered incapable of eliciting a toxic response.

 i. Food. NA-Remove

 ii. Drinking water. NA-Remove

 2. Non-dietary exposure. Typical uses of modified acrylic polymers are in the laundry 

detergents, auto dish wash detergents, and bathroom hard surface cleaners. In these uses the 

primary exposures are dermal; however, modified acrylic polymers with a molecular weight 

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

considered incapable of eliciting a toxic response.

D. Cumulative Effects

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

polymers. Polymers 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. Therefore, 

there is no reasonable expectation of increased risk due to cumulative exposure. Based on this 

polymer conforming to the definition of a polymer and meeting the criteria of a low risk 

polymer under 40 CFR 723.250, Akzo Nobel Surface Chemistry LLC believes there are no 

concerns for risks associated with cumulative effects.

E. Safety Determination

 1. U.S. population. NA-Remove

 2. Infants and children. NA-Remove

F. International Tolerances

 NA-Remove