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



### ATTENTION: All commodity terms must comply with the Food and Feed 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 Ac t (FFDCA), 21 U.S.C. 346a(d), to revise an existing exemption from the requirement of a tole rance for modified acrylic polymers located in 40 CFR part 180.960. EPA has determined that th e 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 ofassociated 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, amm onium, monoethanolamine and triethanolamine salts; the resulting po lymer having a minimum number averag e molecular weight (in amu), 1200. This citation begins with the following : Styrene, copolymers with acrylic acid.

A. Residue Chemistry

1. Plant metabolism

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2. Analytical method

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3. Magnitude of residues

. Akzo Nobel Surface Chemistry LLC is petitioning for an exemption from the requirement of a toleranc e based upon the polymer’ s compliance with the Low Risk Polymer criteria per 40 CFR 723.250. Ther efore, an analytical method to determine residues in raw agricultural commod ities has not been pr oposed. No residue chemistry data or environmental fate data are presen ted 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 lo w 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 723.25 0 ) identify polymers that are relatively unreactive and stab le compared to other ch emical substances as well as polymers that typically are not readily absorbed. Ak zo Nobel Surface Chemistry LLC believes that Styrene, acrylic ac id, lauryl methacrylate copolyme rs conform to the definition of a polymer given in 40 CFR 723.250 and meets the criteria us ed 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 poly mers will present minimal or no risk.

1. This polymer is not a cationic substance. 2. It contains as an integr al 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 lis ted in 40 CFR 723.250(d)(2)(ii) . 4. This polymer is not designed or reasonab ly 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 Substa nce 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 substa nces with molecular weights greater than 1,000 are generally not absorbed through the inta ct 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 believe s sufficient information was submitted in the petition to assess the hazards of the Styrene, acrylic acid, lauryl methacrylate7

copolymers. No toxicology data were presente d in the petition as the Agency does not generally require some or all of the listed st udies to rule on the exemption from the requirement of a tolerance for an inert ingredie nt. 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 be lieves there are no concerns for risks associated with toxicity.

2. Genotoxicty

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3. Reproductive and developmental toxicity

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4. Subchronic toxicity

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5. Chronic toxicity

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6. Animal metabolism

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7. Metabolite toxicology

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8. Endocrine disruption

. There is no evidence that th e polymer is an endocrine disrupter. Substances with molecular weight s 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 in tact gastrointestinal (GI) tr act. Chemicals not absorbed through the skin or GI tract generally ar e incapable of elicit ing a toxic response. EPA is not requiring information on the en docrine effects of this substance at this time; Congress has allowed 3 years after Au gust 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 m ay be used in contact with food as components of containers used to manufactur e, process, or store food when regulated for
such use under the Federa l Food, Drug, and Cosmetic Act. Modified acrylic polymers with a8

molecular weight greater than 1,000 daltons are not readily absorbed through the intact gastrointestinal tract and are considered in capable of eliciting a toxic response.

i. Food

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ii. Drinking water

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2. Non-dietary exposure

. Typical uses of modified acryli c polymers are in the laundry detergents, auto dish wash detergents, and bathro om 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 readil y absorbed through the intact skin and are considered incapable of e liciting a toxic response.

D. Cumulative Effects

There is data to support a conc lusion of negligible cumulati ve risk for modified acrylic polymers. Polymers with molecular weights gr eater than 400 genera lly are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact gastrointe stinal (GI) tract. Chemicals not absorbed through the skin or GI tract generally are incapable of elic iting a toxic response. Therefore, there is no reasonable expectatio n of increased risk due to cumula tive exposure. Based on this polymer conforming to the definition of a po lymer and meeting the criteria of a low risk polymer under 40 CFR 723.250, Akzo Nobel Surf ace Chemistry LLC be lieves there are no
concerns for risks associated with cumulative effects.

E. Safety Determination

1. U.S. population

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2. Infants and children

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F. International Tolerances

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