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EPA REGISTRATION DIVISION CO MPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [ PV Shah, 703-308-1846 ]

INSTRUCTIONS: Please utilize this outline in p reparing the pesticide petition. In

cases where the outline element does not apply, please insert “NA-Remove” and

maintain the outline. Please do not chan ge 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:

[ 1E7880]

EPA has received a pesticide petition (1E7880) from [Clariant Corporation], [4000 Monroe Rd, Charlotte NC 28205] 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 to establish an exemption from the requirement of a tolerance for

[Poly(oxy-1,2-ethanediyl), α -hydro- ω -hydroxy-, Mn 17000 amu and CAS Reg. no. 25322-68-3 under 40 CFR 180.960 when used as an inert ingredient in pesticide formulations as a solubilizer without limitations. EPA has determined that the petition contains data or information regarding the elemen ts 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 s upports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism.

2. Analytical method. [Clariant Corporation is petitioning that Poly (oxy-1,2- ethanediyl), α -hydro- ω -hydroxy- be exempt from the requirement of a tolerance based upon the definition of a low-risk polymer under 40 CFR 723.250. Therefore, an analytical method to determine residu es on treated crops is not relevant.

3. Magnitude of residues. [Clariant Corporation is pe titioning that Poly (oxy1,2-ethanediyl), α -hydro- ω -hydroxy- be exempt from the requirement of a tolerance based upon the definition of a low-risk polymer under 40 CFR 723.250. Therefore, magnitude of residues on tr eated crops is not relevant .]

B. Toxicological Profile2

1. Acute toxicity. [No toxicological data is subm itted with, or referenced in this tolerance exemption petition because Poly (oxy-1,2-ethanediyl), α -hydro- ω - hydroxy- 

### meets the definition of a low-risk polymer under 40 CFR 723.250.

1. Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### is a polymer molecule as defined by 40 CFR 723.250(b). That is, it contains a sequence of at

least 3 monomer units which are cova lently bound to at least one other

monomer unit or other reactant.

2. Poly (oxy-1,2-ethanediyl), α -hydro-w-hydroxy- 

### has a number average molecular weight of 20,000 and c ontains less than 0.1 percent oligomeric material below molecu lar weight 500 and 1,000 molecular weight.

3. Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### is not a cationic polymer and is not anticipated to become a cationic polymer in a natural aquatic environment.

4. Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### only contains the elements carbon, hydrogen, and oxygen; therefore, it meets the criteria for elemental composition.

5. 

### The polymer does not contain as an integral part of its composition, except as impurities, any element ot her than those listed in 40 CFR 723.250(d)(2)(ii).

6. Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### is not designed or reasonably anticipated to substan tially degrade, decompose, or depolymerize under normal use conditions.

7. Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### is not manufactured or imported from monomers a nd/or other reactants that are not already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

8. Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### is not a water-absorbing polymer with a number average molecular weight above 10,000

daltons.

9. Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### contains no reactive functional groups that fail to meet the low-risk polymer exemption criteria under 40 CFR 723.250(e). ]

]

2. Genotoxicty. [NA-remove]

3. Reproductive and developmental toxicity. [NA-remove]

4. Subchronic toxicity. [NA-remove]3

5. Chronic toxicity. [NA-remove]

6. Animal metabolism. [NA-remove]

7. Metabolite toxicology

. [NA-remove]

8. Endocrine disruption

. [NA-remove]

C. Aggregate Exposure

1. Dietary exposure. [The physical and chemical ch aracteristics of Poly (oxy1,2-ethanediyl), α -hydro- ω -hydroxy- 

### lead to the conclusion that there is a reasonable certainty of no harm from exposure to the polymer from food or drinking water. ]

i. Food. [Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- with molecular weight in the range of 200-9500 has clearances under 21CFR 178.3750]

ii. Drinking water. [NA-remove]

2. Non-dietary exposure

. [The physical and chemical characteristics of Poly
(oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### lead to the conclusion that there is a reasonable certainty of no harm from ex posure to the polymer from exposure to the polymer through non-dietary means. ]

D. Cumulative Effects

[Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### is a low-risk polymer. There is no information at this time to suggest that any toxic effects produced by this inert ingredient would be cumulative with any other

chemical ]

E. Safety Determination

1. U.S. population. [Poly (oxy-1, 2-ethanediyl), α -hydro- ω -hydroxy- 

### meets all the criteria for qualification as a low-risk polymer under 40 CFR

723.250. Adverse effects on the U.S. population are not expected from the use of this inert ingredient in pesticide formulations. ]

2. Infants and children

. [Poly (oxy-1,2-ethanediyl), α -hydro- ω -hydroxy- 

### is a low-risk polymer. No adverse effects are expected from use of this inert ingredient in pesticide formulations . Based on the physical and chemical properties of the molecule, there is no reason to believe that infants and4



### children will be disproportionately at risk. ]

F. International Tolerances

[There are no known U.S. or intern ational tolerances for Poly (oxy-1,2- ethanediyl), α -hydro- ω -hydroxy-]