EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact:

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:

Sekisui Specialty Chemicals

2E8082

EPA has received a pesticide petition (2E8082) from [Sekisui Specialty 

Chemicals], [1501 West LBJ Freeway, Dallas, TX 75234] 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 180.960 to establish to establish an exemption from the 

requirement of a tolerance for [2-pyrrolidone, 1-ethenyl-, polymer with ethenol (CAS

Reg. No. 26008-54-8) under 40CFR 180.960] in or on the raw agricultural commodity

[as a packaging film for unit dose packaging of pesticides and pool sanitizers]. 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. [NA - Remove]

2. Analytical method. [NA - Remove]

3. Magnitude of residues. [NA - Remove]

B. Toxicological Profile

[Polymer Exemption Language

2-pyrrolidone, 1-ethenyl-, polymer with ethenol, is composed of at least 3 

monomer units and other reactant.
2

2-pyrrolidone, 1-ethenyl-, polymer with ethenol, consists of a simple weight 

majority of the polymer molecules. The monomer distribution in the polymer 

is completely random and the distribution of the molecular weight of the 

polymer is due largely to the number of monomer units in the individual 

molecules.

2-pyrrolidone, 1-ethenyl-, polymer with ethenol, will not become cationic in 

an aquatic environment, and it contains no moieties capable of obtaining a 

cationic charge.

2-pyrrolidone, 1-ethenyl-, polymer with ethenol, is composed of carbon, 

hydrogen, nitrogen, and oxygen, and meets the criteria of elemental 

composition. Sodium exists as a monatomic counterion.

2-pyrrolidone, 1-ethenyl-, polymer with ethenol, will not degrade, decompose 

or depolymerize.

All materials used to prepare 2-pyrrolidone, 1-ethenyl-, polymer with 

ethenol, are on the TSCA Chemical Substance Inventory or are 

manufactured under an applicable TSCA section 5 exemption.

Although the number average molecular weight of 2-pyrrolidone, 1-ethenyl-, 

polymer with ethenol, exceeds 10,000 and it is water soluble, it does not fit 

the definition of water absorbing polymer in that it does not absorb its 

weight of water.

2-pyrrolidone, 1-ethenyl-, polymer with ethenol, consists of a number 

average molecular weight of 22,900 with zero percent of its oligomeric 

material weighing below 500 daltons and zero percent of its oligomeric 

material weighing less than 1,000 daltons.]

1. Acute toxicity. [NA – Remove]

2. Genotoxicty. [NA - Remove]

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

4. Subchronic toxicity. [NA - Remove ]

5. Chronic toxicity. [NA - Remove ]

6. Animal metabolism. [NA - Remove ]

7. Metabolite toxicology. [NA - Remove ]
3

8. Endocrine disruption. [NA - Remove ]

C. Aggregate Exposure

1. Dietary exposure. [The physical and chemical characteristics of 2-

pyrrolidone, 1-ethenyl-, polymer with ethenol leads to the conclusion that 

there is reasonable certainty of no harm from exposure to the polymer from 

food or drinking water nor from an aggregate exposure.]

i. Food. [NA – Remove ]

ii. Drinking water. [NA - Remove]

2. Non-dietary exposure. [The physical and chemical characteristics of 2-

pyrrolidone, 1-ethenyl-, polymer with ethenol leads to the conclusion that there is 

reasonable certainty of no harm from exposure to the polymer from non-dietary 

means.]

D. Cumulative Effects

[At this time there is no information to indicate that any toxic effects 

produced by 2-pyrrolidone, 1-ethenyl-, polymer with ethenol would be cumulative 

with any other chemical. Given the compound’s categorization as a low risk 

polymer, and its proposed use in pesticide and sanitizer packaging, there is no 

expectation of increased risk due to cumulative exposure.]

E. Safety Determination

1. U.S. population. [Based on the polymer’s physical and chemical properties, 

and that it meets or exceeds the polymer exemption criteria at 40CFR 723.250 for 

low risk polymers, adverse effects are not expected.]

2. Infants and children. [Based on the polymer’s physical and chemical 

properties, and that it meets or exceeds the polymer exemption criteria at 40CFR 

723.250 for low risk polymers, adverse effects are not expected.]

F. International Tolerances

[There are no CODEX maximum residue limits established for 2-

pyrrolidone, 1-ethenyl-, polymer with ethenol, in or on crops or commodities at this 

time.]