Document ID: EPA-HQ-OPP-2014-0324-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-08-01T04:00Z

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

EPA Registration Division contact: P. V. 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.

TEMPLATE:

Specialty  Fertilizer Products LLC
IN-10697

	EPA has received a pesticide petition, IN-10697 (from Specialty Fertilizer Products LLC, 11550 Ash Street, Suite 220, Leawood KS 66211) 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 an exemption from the requirement of a tolerance for butanedioic acid, 2-methylene-, polymer with 2,5-furandione, sodium and ammonium salts, hydrogen peroxide-initiated (CAS Reg. No. 556055-76-6 and 701908-99-8) in or on all raw agricultural commodities under 40 CFR 180.960 when used as a suspension agent in agricultural 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

	1. Plant metabolism. [NA-REMOVE based on the fact that this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met]

	2. Analytical method. [NA-REMOVE based on the fact that this information is generally not required when all criteria for polymer exemption are met and when petitioning for an exemption from the requirements of a tolerance without any numerical limitations.]

	3. Magnitude of residues. [NA-REMOVE based on the fact that this information is generally not required when all criteria for a polymer exemption per 40 CFR 723.250 are met.]

B. Toxicological Profile

      1. Acute toxicity.  [EPA has established criteria which identify categories of polymers that present low risk.  These criteria (codified at 40 CFR 723.250) identify polymers with properties that make them relatively unreactive and stable as well as not readily absorbed as compared to other chemical substances.  These properties generally limit a polymer's ability to cause adverse toxicological effects.  No mammalian toxicity is anticipated from dietary, inhalation or dermal exposure for polymers meeting the polymer exemption criteria. Therefore Specialty Fertilizer Products believes that establishment of an exemption from the requirements of a tolerance is justified for butanedioic acid, 2-methylene-, polymer with 2,5-furandione, sodium and ammonium salts, hydrogen peroxide-initiated.  Furthermore, no aggregate risk to human health is expected due to exposure to residues of this copolymer under reasonably foreseeable circumstances of use.  Butanedioic acid, 2-methylene-, polymer with 2,5-furandione, sodium and ammonium salts, hydrogen peroxide-initiated meets the definition of a polymer as well as all of the specific criteria under 40 CFR 723.250 as described below:
         
      a. The polymer is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
      b. The polymer contains as an integral part of its composition the elements carbon and hydrogen. 
      c. The polymer does not contain as an integral part of its composition any elements other than those listed in 40 CFR 723.250.
      d. The polymer is not expected to substantially degrade, decompose or depolymerize during use.
      e. The polymer is manufactured only from monomers and/or reactants that are already included on the TSCA Chemical Substances Inventory.
      f. The polymer is not a water absorbing polymer.
      g. The polymer does not contain any reactive functional groups that can be ionized to a cation.
      h. The polymer's number average MW is greater than 2,500 daltons.  The polymer contains substantially less than 2% oligomeric material below MW 500 and less than 2% oligomeric material below MW 1000. 

      1. Genotoxicty. [NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymers as codified in 40 CFR 723.250.  In particular, substances with molecular weights greater than 1000 Daltons generally are not absorbed through intact skin, nor are they generally absorbed from the gastrointestinal tract.  Chemicals not absorbed through the skin or through the gastrointestinal tract are generally not capable of producing a toxic response.]   
      

      2. Reproductive and developmental toxicity. [NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymers as codified in 40 CFR 723.250.  In particular, substances with molecular weights greater than 1000 Daltons generally are not absorbed through intact skin, nor are they generally absorbed through the intact gastrointestinal tract.  Chemicals not absorbed through the skin or through the gastrointestinal tract are generally not capable of producing a toxic response.]

	4. Subchronic toxicity. [NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymers as codified in 40 CFR 723.250.  In particular, substances with molecular weights greater than 1000 Daltons generally are not absorbed through intact skin, nor are they generally absorbed from the gastrointestinal tract.  Chemicals not absorbed through the skin or through the gastrointestinal tract are generally not capable of producing a toxic response.]

	5. Chronic toxicity. [NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250.  In particular, substances with molecular weights greater than 1000 Daltons generally are not absorbed through intact skin, nor are they generally absorbed from the gastrointestinal tract.  Chemicals not absorbed through the skin or through the gastrointestinal tract are generally not capable of producing a toxic response.]

	6. Animal metabolism. [NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250.  In particular, substances with molecular weights greater than 1000 Daltons generally are not absorbed through intact skin, nor are they generally absorbed from the gastrointestinal tract.  An animal metabolism study would therefore not be relevant for a material that does not absorb through the skin or the gastrointestinal tract.]

	7. Metabolite toxicology. [NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250.  In particular, substances with molecular weights greater than 1000 Daltons generally are not absorbed through intact skin, nor are they generally absorbed from the gastrointestinal tract.  Chemicals not absorbed through the skin or through the gastrointestinal tract are generally not capable of producing a toxic response.]

	8. Endocrine disruption. [NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250.  In particular, substances with molecular weights greater than 1000 Daltons generally are not absorbed through intact skin, nor are they absorbed through the intact gastrointestinal tract.  Chemicals not absorbed through the skin or from the gastrointestinal tract are generally not capable of producing a toxic response, including toxicity related to endocrine disruption.]

C. Aggregate Exposure

	1. Dietary exposure. [NA-REMOVE based on the fact that this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met.]

	i. Food. [NA-REMOVE based on the fact that this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met.]

	ii. Drinking water. [NA-REMOVE based on the fact that this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met.]

	2. Non-dietary exposure. [NA-REMOVE based on the fact that this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met.]

D. Cumulative Effects

	[NA-REMOVE based on the fact that this polymer conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 173.250.  In particular, substances with molecular weights greater than 1000 Daltons are generally not absorbed through intact skin, nor are they absorbed from the gastrointestinal tract.  Chemicals not absorbed through the skin or through the intestinal tract are generally not capable of producing a toxic response.]

E. Safety Determination

	1. U.S. population. [Based on the conformity of this polymer to the criteria used to identify low risk polymers, there is a reasonable certainty of no harm to the US population from aggregate exposure to residues of this polymer.]

	2. Infants and children. [Based on the conformity of this polymer to the criteria used to identify low risk polymers, there is a reasonable uncertainty of no harm to infants and children from aggregate exposures of this polymer.  In addition, there is no evidence to indicate that infants and children would be more susceptible to adverse effects from exposure to this polymer]

F. International Tolerances

	[Specialty Fertilizer Products is not aware of any country requiring a tolerance for copolymer.  In addition, no Codex MRLs have been established for copolymer at this time.]