Document ID: EPA-HQ-OPP-2018-0546-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-10-18T04:00Z

APPENDIX A
                                       
                               NOTICE OF FILING

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

EPA Registration Division contact: Kerry Leifer 703-308-8811

Synthomer USA LLC

IN-11189

	 (IN-11189 EPA-HQ-OPP-2018-0546) Keller and Heckman LLP, 1001 G Street, NW, Suite 500 West, Washington, DC 20001, on behalf of Synthomer USA LLC, requests to amend an exemption from the requirement of a tolerance , 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 residues of polyvinyl acetate  -  polyvinyl alcohol copolymer with a minimum number average molecular weight (in amu),  14,500 (CAS Reg. No. 25213-24-5) under 40 CFR §180.960 in or on raw agricultural commodities when used as a pesticide inert ingredient in pesticide formulations without limitation. 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. No specific plant metabolism data is available, nor is it required for the establishment of a tolerance exemption.

	2. Analytical method. NA-Remove. An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. 

	3. Magnitude of residues. NA-Remove. Information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required for the establishment of a tolerance exemption.

B. Toxicological Profile

    Polyvinyl acetate - polyvinyl alcohol copolymer is a polymer as defined by 40 CFR 723.250(b).
    Polyvinyl acetate - polyvinyl alcohol copolymer will not become cationic in an aquatic environment.
    Polyvinyl acetate - polyvinyl alcohol copolymer is composed of hydrogen, oxygen, and carbon: therefore, it meets the criteria of elemental composition.
    Polyvinyl acetate - polyvinyl alcohol copolymer 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).
    Polyvinyl acetate - polyvinyl alcohol copolymer is not designed nor reasonably expected to substantially degrade, decompose, or depolymerize under normal conditions of manufacture, use and disposal. 
    Polyvinyl acetate - polyvinyl alcohol copolymer is composed of molecules that are listed on the TSCA Inventory or manufactured under an applicable TSCA section 5 exemption.
    Polyvinyl acetate - polyvinyl alcohol copolymer is not a water absorbing polymer and cannot absorb its own weight in water.
    Polyvinyl acetate - polyvinyl alcohol copolymer does not contain any perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6). 
    Polyvinyl acetate - polyvinyl alcohol copolymer consists of a number average molecular weight of greater than 10,000 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-chemical characteristics of polyvinyl acetate  -  polyvinyl alcohol copolymer leads to the conclusion that there is a reasonably 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-chemical characteristics of polyvinyl acetate  -  polyvinyl alcohol copolymer lead to the conclusion that there is a 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 polyvinyl acetate  -  polyvinyl alcohol copolymer would by cumulative with any other chemical. Given the compound's categorization as a low risk polymer, and its proposed use in pesticide formulations, there is no expectation of increased risk due to cumulative exposure.

E. Safety Determination

	1. U.S. population. Based on the polymer's physical-chemical properties, and that it meets or exceeds the polymer exemption criteria at 40 CFR 723.250 for low-risk polymers, adverse effects are not expected.

	2. Infants and children. Based on the polymer's physical-chemical properties, and that it meets or exceeds the polymer exemption criteria at 40 CFR 723.250 for low-risk polymers, adverse effects are not expected.

F. International Tolerances

      The Codex Alimentarius Commission (Codex) has not established a MRL for polyvinyl acetate - polyvinyl alcohol copolymer and there are no maximum residue limits established for polyvinyl acetate - polyvinyl alcohol copolymer in or on crops or commodities of which the petitioner is aware.
                                       
                                       
                                       
                                       
                                       
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