Document ID: EPA-HQ-OPP-2017-0362-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2017-09-15T04:00Z

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

EPA Registration Division contact: PV Shah, (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.

Eco Verde Technologies Inc.

[IN-11043]

	EPA has received a pesticide petition ([IN-11043]) from Eco Verde Technologies Inc., 400 N.W. 172[nd] Avenue, Pembroke Pines FL  33029 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

      Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether (CAS #1998118-31-2; number average molecular weight  5.77x10[9] D) under 40 CFR 180.960 when used as a releasing agent/UV protector applied to growing crops or harvested crops 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 NA remove

	1. Plant metabolism.

	2. Analytical method. NA remove

	3. Magnitude of residues. NA remove

B. Toxicological Profile  Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether  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:

 The polymer has a low cationic density (the percent of cationic or potentially cationic species with respect to the overall weight of polymer) with a functional group equivalent weight greater than 5,000 daltons. These polymers are not considered to pose an unreasonable risk of injury to human health or the environment.
 The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, nitrogen and oxygen.
 The polymer 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).
 The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. Biodegradation testing supported this.
 The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory.
 The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.
 The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6).
   
   Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
 The polymer's minimum number average MW is 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.
      
Thus, Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me 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 Formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether.

	1. Acute toxicity.  N/A Remove

	2. Genotoxicty.  N/A Remove

	3. Reproductive and developmental toxicity. N/A Remove

	4. Subchronic toxicity.  N/A Remove

	5. Chronic toxicity. N/A Remove 

	6. Animal metabolism. The absorption of Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether is not anticipated to be significant through skin, by inhalation, or from the gastrointestinal tract based on its high molecular weight.

	7. Metabolite toxicology. N/A Remove

	8. Endocrine disruption. N/A Remove

C. Aggregate Exposure
The minimum number average MW of Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether >10[9] amu. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me 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.
	
      1. Dietary exposure. N/A Remove

	i. Food. N/A Remove

	ii. Drinking water. N/A Remove

	2. Non-dietary exposure. N/A Remove

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 for Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether and other compounds.    

E. Safety Determination

	1. U.S. population.  Based on the conformance to the criteria used to identify a low-risk polymer,  there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether.   

	2. Infants and children. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether, the additional tenfold safety factor is unnecessary.  

F. International Tolerances

	N/A Remove