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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS 

PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: P.V.Shah, 702-308-1846

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:

BYK USA Inc.

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from BYK USA 

Inc., 524 South Cherry Street, Wallingford, CT 06492-4453 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(methyl-1,2-ethanediyl)], q-[(92)-1 -oxo-9-octadecen-1 -
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yll-o-[[(92)-1 -oxo-9-octadecen-1 -yl]oxyl- (number average molecular weight (Mn) of 

2356 daltons; CAS #26571-49-3) under 40 CFR 180.960 when used as an inert ingredient 

defoamer 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 granting of the petition. Additional data may be needed 

before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism.

2. Analytical method. NA-Remove

3. Magnitude of residues. NA-Remove

B. Toxicological Profile There were no toxicity data identified for Poly[oxy(methyl-1,2-

ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]-. 

Typically, polymers with molecular weight >1000 and a low fraction of low-weight 

oligomers are not considered bioavailable, and therefore are of low concern for toxicity.

Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-

octadecen-1-yl]oxy]- meets the criteria used to identify Low Risk Polymer exemption 

under 40 CFR 723.250 (d): 

1. the polymer is not a cationic polymer nor is it reasonably anticipated to become 

a cationic polymer in a natural aquatic environment;

2. the polymer contains as an integral part of its composition carbon, hydrogen, 

and oxygen;

3. the polymer does not contain as an integral part of its composition any element 

other than those listed in 40 CFR 723 .250(d)(2)(ii);

4. the polymer is neither designed nor can it be reasonably anticipated to 

substantially degrade, decompose, or depolymerize;
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5. the polymer is manufactured from monomers and reactants that are already 

included on the TSCA Chemical Substance Inventory or manufactured under an 

applicable TSCA section 5 exemption;

6. the polymer is not a water-absorbing polymer with a number average molecular 

weight greater than or equal to 10,000 daltons;

7. the polymer does not contain, as an integral part of its composition, 

perfluoroalkyl moieties;

8. the polymer meets the following exemption criterion specified in 40 CFR 

723.250(e): The polymer’s number average molecular weight is greater than 

1,000 and less than 10,000 daltons. The polymer contains less than 10% 

oligomeric material below MW 500 and less than 25% oligomeric material below 

MW 1,000. The polymer does not contain any reactive functional groups. 

1. Acute toxicity. There were no toxicity data identified for Poly[oxy(methyl-1,2-

ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]-. 

Typically, polymers with molecular weight >1000 and a low fraction of low-weight 

oligomers are not considered bioavailable, and therefore are of low concern for toxicity.

This polymer meets the requirements specified in 40CFR 723.250 of a low risk polymer.

2. Genotoxicty. [ibid.]

3. Reproductive and developmental toxicity. [ibid.]

4. Subchronic toxicity. [ibid.]

5. Chronic toxicity. An evaluation of the potential carcinogenicity of 

Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-

octadecen-1-yl]oxy]- was carried out using the modeling program OncoLogic. Based on 
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its classification as a high molecular weight polymer and the lack of reactive functional 

groups on the side chains, the level of carcinogenicity concern for this polymer was 

determined to be low. The polymer is not known to have demonstrated an ability to be 

absorbed and to accumulate in soft tissue. Furthermore, the polymer is not a concern 

for lung overload, and does not contain hindered amine groups or terminal double 

bonds, all further indicating that the level of concern is low.

6. Animal metabolism. The metabolism of Poly[oxy(methyl-1,2-ethanediyl)], α-

[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]- has not been 

studied. Typically, absorption of high molecular weight polymers (Mn>1000 Daltons) is 

not significant through skin, inhalation, or from the gastrointestinal tract. Therefore this 

polymer is not expected to be biologically available to mammalian systems.

7. Metabolite toxicology. NA-Remove

8. Endocrine disruption. [Toxicity related to endocrine disruption was not 

observed in the currently available database for Poly[oxy(methyl-1,2-ethanediyl)], α-

[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]-. As the science 

develops and resources allow, screening of additional compounds may be added to the 

Endocrine Disruptor Screening Program (EDSP), at which point Poly[oxy(methyl-1,2-

ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]- may 

be subjected to additional screening and/or testing to better characterize effects related 

to endocrine disruption.

C. Aggregate Exposure

1. Dietary exposure. Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]- is a component of a defoamer intended to be 

used in food-use pesticides at a low use-level. Therefore, dietary exposure is expected 

to be negligible. 

i. Food. ibid.
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ii. Drinking water. ibid.

2. Non-dietary exposure. Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-

octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]- is not expected to volatilize or be 

significantly bioavailable, given its high molecular weight. Likewise, significant exposure 

to workers that mix, load and apply pesticides containing this inert ingredient is not 

expected based on the use levels of this compound described in this petition, its low 

volatility, and low bioavailability. 

D. Cumulative Effects

Section 408(b)(2)(D) (9v) of the FFDCA requires that, when considering whether to 

establish, modify, or revoke a tolerance, the Agency consider “available information” 

concerning the cumulative effects of a particular pesticide’s residues and “other 

substances that have a common mechanism of toxicity.” EPA has not made a common 

mechanism of toxicity finding as to Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-

octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]- and other compounds. 

Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-

octadecen-1-yl]oxy]- does not appear to produce toxic metabolites in common with 

other substances. 

E. Safety Determination

1. U.S. population. The available information presented in this report indicates 

with reasonable certainty that no harm to humans will result from using 

Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-

octadecen-1-yl]oxy]- as an inert ingredient in pesticide formulations. This high weight 

molecular polymer meets the criteria used to identify low risk polymers under 40 CFR 

723.250.
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2. Infants and children. There is a reasonable certainty that no harm to infants 

and children will result from the use of Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1-yl]oxy]- as an inert ingredient in 

pesticide products because this is a low risk polymer, as defined under 40 CFR 723.250.

F. International Tolerances

NA-Remove