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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, 703-308-1846] 

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: 

[ 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 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. [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 residues on treated crops is not relevant.

 3. Magnitude of residues. [Clariant Corporation is petitioning 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 treated crops is not relevant.]

B. Toxicological Profile
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 1. Acute toxicity. [No toxicological data is submitted 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 covalently 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 contains less than 0.1 percent 

oligomeric material below molecular 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 other 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 substantially 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 and/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]
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 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 characteristics 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 exposure 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 and 
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children will be disproportionately at risk.]

F. International Tolerances

 [There are no known U.S. or international tolerances for Poly (oxy-1,2-

ethanediyl), α -hydro- ω -hydroxy-]