I 

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [PV Shaw (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: 

[Evonik Goldschmidt Corporation] 

[Insert petition number] 

EPA has rcce1vcd a pestictde petition (INA-Remove]) from [Evonik 

Corporation], [PO Box 1299, Hopewell, VA 23860] proposing, pursuant to section 

408(d) ofthe Federal Food, Drug, and Cosmet1c Act (FFDCA), 21 U.S.C. 346a(d), to 

amend 40 CFR part 180. 

(Options (pick one) 

I. by establishing a tolerance for residues of- NA-Remove 

2. to establish an exemption from the requirement of a tolerance for 

[Oxirane, 2-phenyl-, polymer with oxirane, monooctyl ether, minimum 

number average molecular weight (in AMU) 1,271 and CAS Reg. No. 83653-00-3] 

under 40 CFR , 0 960 \\hen used a:-. .m 111<.:n mgred1ent (functiomng as 1 dtspersant) in 

pesticide tonnulations. EPA has detennined that the petition contains data or 

information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, 

EPA ha:. not fully C\ aluated the sutlicicncy of the submitted data at this time or whcthi'J 

the data supports granting of the petition. Additional data may be needed before EPA 

rules on the petition. 

A. Residue Chcmi\'fl'\' 

I. Plallf metaboli'im. 

2. Anal\ tical merlzo NA-Removc 

2 
2 

3. \1agnitude of re.sidues NA-Remove 

B. l oxicological Profile 

l. Acllle toxicitJ NA-Remove 

2. Genotoxicty NA-Remove 

3. Reproductive and derelopmelllal toxicifl NA-Remove 

4. Subchronic uniciz\ NA-Remove 

5. Chrome toxicif\ NA-Remove 

6 . . 1nimal metabolism. NA-Remove 

7. Metabolite toxicolog) NA-Remove 

8. Endocrine disrupti01 NA-Remove 

The def"mition of a polymer is given in 40 CFR 723.250(b) and the 

exclusion criteria for identifying these low-risk polymers are 

described in 40 CFR 723.250(d). Oxirane, 2-phenyl-, polymer with oxirane, 

monooctyl ether, minimum number average molecular weight (in AMU) 1,271 and 

CAS Reg. No. 83653-00-3 conforms to the definition of a polymer given in 40 CFR 

723.250(b) and meets the following criteria that are used to identify low-risk 

polymers. 

1. The polymer is not cationic, nor does it have the potential to become cationic. 

2. The polymer does contain as an integral part of its composition 

the atomic elements carbon, hydrogen, and oxygen. 

3. The polymer docs 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). 

4. The polymer is neither designed nor can it be reasonably 

anticipated to substantially degrade, decompose, or depolymerizc. 

5. The polymer is manufactured or imported from monomers and/or 

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 (MW) greater than or equal to 10,000 daltons. 

Additionally, the polymer also meets as required the following 

exemption criteria specified in 40 CFR 723.250(e)(l). 

7. The polymer's number average MW of 1,271 daltons and contains 

approximatel) 1% oligomeric material below M\V 500 and 12% material below 
3 

MW 1000, ther efore satisfying the number average molecular weight and oligomeric 

content requirement specified under 723.2SO(e)(l). 

Thus, Oxirane, 2-phenyl-, polymer with oxirane, monooctyl ether meets the criteria 

for a polymer to be considered low risk under 40 CFR 723.250. 

Based on its conformance to the criteria in this unit, no mammalian 

toxicity is anticipated from dietary, inhalation, or dermal exposure to 

Oxirane, 2-phen yl-, polymer with oxirane, monooctyl ether. 

For the purposes of assessing potential exposure under this exemption, EPA 

considered that Oxiranc, 2-phenyl-, polymer with oxirane, monooctyl ether could be 

present in all raw and processed agricultural commodities and drinking water, and that 

non-occupational non-dietary exposure was possible. The number average MW of 

Oxirane, 2-phenyl-, polymer with oxirane, monooctyl ether is 1,271 daltons. Generally, a 

polymer of this size would be poorly absorbed through the intact gastrointestinal tr act or 

through intact human skin. Since Oxirane, 2-phenyl-, polymer with oxirane, monooctyl 

ether conforms to the criteria that identify a low-risk polymer, there are no concerns for 

risks associated with any potential exposure scenarios that are reasonably foreseeable. 

l. Die/at)' e.\posure. NA-Remove 

i. Food NA-Remove 

ii. Drinl..ing ware NA-Remove 

2. Non-dietliiJ' e:~.posure. NA-Remove 

n. Cumulati\·e E.f!i.•cts 

Section 408(b)(2)(D)(v) of 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 found Oxirane, 2-phenyl-, polymer with oxirane, monooctyl ethe .. to 

share a common mechanism of toxicity with any other substances, and 

Oxirane, 2-phenyl-, polymer with oxirane, monooctyl ether does not appear to 

produce a toxic metabolite produced by other substances. For the purposes of t;ais 

tolerance action, therefore, EPA bas assumed that Oxirane, 2-phenyl-, polymer witt: 

oxirane, monooctyl ether does not have a common mechanism of toxicity with other 

substances. 

E Safety Determination 
4 

S r 1 ' 11 Oxirane, 2-pbenyl-, polymer with oxirane, monooctyl 

ether, qualifying as a low concern polymer, is not expected to pose toxicity risk. 

2. lnfant'i and clllldren. Due to the low toxicity of Oxirane, 2-pbenyl-, polymer 

with oxirane, monooctyl ether, a safety factor analysis is not necessary. 

F. Imernational Tolerances 

The Codex bas not established a MRL for Oxirane, 2-pbenyl-, polymer 

with oxirane, monooctyl ether.