


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

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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-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 ]

	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.]




