Document ID: EPA-HQ-OPP-2017-0248-0002
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, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-001; telephone number:  703-308-1846; email address:  shah.pv@epa.gov

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:

BASF Corporation

[EPA Petition number: IN-11044]

	EPA has received a pesticide petition (IN-11044) from BASF Corporation, 100 Park Avenue, Florham Park, NJ  07932 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 
Amine salt of styrene acrylic polymer, ammonium salt under 40 CFR 180.960 when used as an inert ingredient as a dispersant/binder in a pesticide formulation 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"

	2. Analytical method. "NA-Remove"

	3. Magnitude of residues. "NA-Remove"

B. Toxicological Profile

	The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d).

       Amine salt of styrene acrylic polymer, ammonium salt is a polymer as defined by 40 CFR 723.250(b).   In addition, Amine salt of styrene acrylic polymer, ammonium salt contains at least 3 monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of a simple weight majority of the polymer molecules.   The monomer sequences form uninterrupted strings in the polymer and distribution of the molecular weight of the polymer is due largely to the number of monomer units in the individual molecules.
      
      2.       Amine salt of styrene acrylic polymer, ammonium salt consists of a number average molecular weight greater than 1,000 daltons and less than 10,000 daltons, <10% of its oligomeric material weighing below 500 daltons and <25% of its oligomeric material weighing less than 1,000 daltons.

      
      3.  Amine salt of styrene acrylic polymer, ammonium salt, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.  The polymer does not contain any functional groups which would dissociate into a cationic moiety in water.  The polymer does not contain a net positively charged atom(s) or associated groups of atoms covalently linked to its polymer molecule.

      4.  The polymer contains as an integral part of its composition the atomic elements carbon, hydrogen, nitrogen and oxygen.

      5.  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).

      6.  The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.  For the purposes of this section, degradation, decomposition, or depolymerization mean those types of chemical change that convert a polymeric substance into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light, or microbial action.
      
      7.  The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

      8.  The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.  Additionally, the polymer, Amine salt of styrene acrylic polymer, ammonium salt, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).  The polymer is not designed to be a water-absorbing polymer that is capable of absorbing its weight of water.
      
      9. The polymer does not contain, as an integral part of its composition, except as impurities, one or more of the following perfluoroalkyl moieties consisting of a CF3- or longer chain length:
      	a. Perfluoroalkyl sulfonates (PFAS),
      	b. Perfluoroalkyl carboxylates (PFAC),
      	c. Fluorotelomers,
      	d. Perfluoroalkyl moieties that are covalently bound to either a   carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule.

    Thus, Amine salt of styrene acrylic polymer, ammonium salt meets all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to Amine salt of styrene acrylic polymer, ammonium salt.

C. Aggregate Exposure

	For the purposes of assessing potential exposure under this exemption, Amine salt of styrene acrylic polymer, ammonium salt could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of Amine salt of styrene acrylic polymer, ammonium salt is greater than 1,000 daltons and less than 10,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since Amine salt of styrene acrylic polymer, ammonium salt 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. Therefore a tolerance is not necessary to protect the public health.

D. Cumulative Effects
      Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, ``available information'' concerning the cumulative effects of a particular chemical's residues and ``other substances that have a common mechanism of toxicity'', must be considered. At this time, available data to determine whether Amine salt of styrene acrylic polymer, ammonium salt has a common mechanism of toxicity with other substances is not available. 

Since Amine salt of styrene acrylic polymer, ammonium salt meets the definition of a low concern polymer, Amine salt of styrene acrylic polymer, ammonium salt is not expected to show any cumulative effects.  

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 Amine salt of styrene acrylic polymer, ammonium salt.

      	2. Infants and children. Section 408 of the 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 Amine salt of styrene acrylic polymer, ammonium salt, based on the polymer meeting the definition of a low risk polymer under 40 CFR 723.250 a safety factor analysis to assess the risk is not necessary. For the same reasons the additional tenfold safety factor is unnecessary.

F. International Tolerances

	There are no CODEX maximum residue limits established for Amine salt of styrene acrylic polymer, ammonium salt in or on crops or commodities at this time.

G. Other Considerations

      1. Endocrine Disruptors:  There is no available evidence that Amine salt of styrene acrylic polymer, ammonium salt is an endocrine disruptor.