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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR
PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: William Cutchin 703

- 305

- 7990

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 re place the instructions that appear in green , i.e., “ [ insert

company name ] ,” with the information specific to your action.

TEMPLATE:

Wack e r Chemical Corporation

I N

- 10890

EPA has received a pesticide petition ( IN

- 10890 ) from Wacker Chemical Corporation, 3301 Sutton Rd., Adrian, ML 49221

- 9397 request ing, 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

s iloxanes and s i licones, 3

- bydroxypropyl Me, eth oxylated ( CAS No. 69430

- 50

- 8 ) , under
40 C FR180.910 when used as a n inert ingredient for the modifi cation of surface tension properties, serving as an anti

- foaming agent in pesticide formulations.

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 grantin g of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

Requirements for data on residue chemistry are not applicable to a request to establish an exemption from requirement of a tolerance, based on conform ance to specific criteria that identify categories of polymers that should present minim um or no risk

.

1. Plant metabolism. NA

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2. Analytical method. NA

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3. Magnitude of residues. NA

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B. Toxicological Profile2

Requirements for data on t oxi c ologi c al properties are not applicable to a request

to establish an exemption from requirement of a tolerance, based on conformance to specific criteria that identify categories of polymers that should present minimal or no ri sk

.

The polymer, s iloxanes and s ilicones, 3

- hydroxypropyl Me, ethoxylated is structurally similar to other polymers listed within the Methylated Silicone category especially the following CAS numbers: 67674

- 67

- 3, 67762

- 85

- 0, 67762

- 87

- 2, 68440

- 66

- 4, 68937

- 54

- 2, 68938

- 54

- 5 and 117272

- 76

- 1 which were included in the EPA 2006 Methylated Silicones inert ingredient reassessment review.

1. The polymer is not a cationi c polymer nor is it reasonably anticipated to become a cationic polymer in the aquatic environme nt.

Justification: The polysiloxane contains no cationic functional groups, nor any moiety that can potentially produce a cationic group.

2. The polymer contains as an integral part of its composition the atomic elements carbon, hydrogen, oxygen and sili con.

Justification: siloxanes and s ilicones, 3

- hydroxypropyl Me, ethoxylated contains four (C, H, O and Si) of the permitted elements (carbon, hydrogen, nitrogen, oxygen, sulfur and silicon), and does not contain any of the elements of concern (fluoride, lithium, boron, phosphorus, etc.).

3. The polymer does not contain as an integral part of its com position except as impurities, any element other than those listed in 40CFR 723.250(d)(2)(ii).

Justification: This polymer s iloxanes and s ilicones, 3

- hydroxy propyl Me, ethoxylated is not expected to contain, except as trace impurities, any of the elements not listed in 40CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose or depoly merize.

Justification: The chemical bonds within this polymer are the same as those present in other siloxanes and silicones, none of which are unstable (as evidenced by the known stability of silicone polymers) and therefore this polymer is expected to b e stable.

5. The polymer is manufa c tured or imported from monomers and or reactants that are

a lready listed on the TSCA Chemic al Substance Inventory or manufa c tured under and applicable TSCA Section 5 exemption.

Justification: CAS 69430

- 50

- 8 is listed on the TSCA Inventory, and both starting

rea c tants: Siloxanes and s ilicones, Me hydrogen CAS 6314 8

- 57

- 2 and e thoxylated allyl3

alcohol (aka p olyethylene glycol, mono

- allyl ether) CAS 27274

- 31

- 3, are listed on the TSCA inventory.

6. The polymer is not a water

- absorbing polymer with a minimum number average molecular weight greater than or equal to 10,000 AMU.

Justification: The polymer is non

- ionic, the calculated average molecular weight is well under the 10,000 AMU upper limit.

7. The polymer meets th e criteria specified in 40CFR 723.250(e)(1).

Justification: The average molecular weight of the polymer is expected to be greater than 1000 AMU but less than 10,000 AMU. This polymer is formed as a by

- product in combination with other polymers made durin g hydrosilylation reactions between hydrogen functional polysiloxanes and polyglycol ethers, these polymers are not typically removed or separated from the reaction mixture. Based on a structural formula analysis the calculated average molecular weight is 2067 AMU using a typical empirical formula
of C86Hi8304iSi7.

The polymer should be considered a low risk un der 40CFR 723.250. Based on its conformance to these criteria no mammalian toxicity is anticipated from dietary ingestion, inhalation or dermal expo sure

1. Acute toxicity. NA

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2. Genotoxicty. NA

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3. Reproductive and developmental toxicity. NA

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4. Subchronic toxicity. NA

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5. Chronic toxicity. NA

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6. Animal metabolism. NA

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7. Metabolite toxicology

. NA

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8. Endocrine disruption

. NA

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C. Aggregate Exposure

For the purposes of assessing potential exposure under this exemption, s iloxanes
and s ilicones, 3

- hydroxypropyl Me, ethoxylated c ould be considered to be present in all
raw and processed agricultural commodities and drinking water, and non

- occupational

non

- dietary exposure is possible. Generally, a silicone polymer of this size would be poorly absorbed through the intact gastrointestinal tract or th rough intact human skin.
Since siloxanes and s ilicones, 3

- hydroxypropyl Me, ethoxylated is expected to behave in a similar manner to other methylated silicones and would conform to the criteria that4

identify a low risk polymer, there should not be any significant concerns for risks

asso ciated with reasonably foreseeable potential exposure scenarios. A tolerance should not be necessary to protect public health.

1. Dietary exposure. NA

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i. Food. NA

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ii. Drinking water

. NA

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2. Non

- dietary exposure

. NA

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D. Cumulative Effects

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider "available information" concerning the cumulative effects of a particular chemical's
residues and "other substances that have a common mechanism of toxicity.".

Wacker Chemical Corporation does not have any available data indicating that

s iloxanes and silicones, 3

- hydroxypropyl Me, ethoxylated has any common mechanism
of toxicity with other substances, and is not likely to produce any toxic metabolites. For the purpos es of this tolerance exemption s iloxanes and s ilico nes, 3

- hydroxypropyl Me, ethoxylated should not be assumed to have a common mechanism of toxicity with othe r substances.

E. Safety Determination

1. U.S. population. NA

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2. Infants and children

. Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects

to account for pre

- natal and post

- natal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and
children.

Due to the expected low toxicity of siloxanes and s ilicones, 3

- hydroxypropyl Me,
eth oxylated a safety factor analysis to assess specific risk to infants and children should not be required. For the same reasons the additional tenfold safety factor is unnecessary.

F. International Tolerances

Wacker Chemical Corporation is not aware of any country requiring a tolerance for Siloxanes and Silicones, 3

- hydroxypropyl Me, ethoxylated nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.5