**EPA REGISTRATION DIVISION COMPA** **NY NOTICE OF FILING FOR PESTICIDE PETI**  **TIONS PUBLISHED IN THE FEDERA L REGISTER**  **EPA Registration Division contact:**  PV Shah , Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 P ennsylvania Ave., N W. , Wa shington, DC 20460 - 001; telephone number: 703 - 308 - 1846 ; email address: shah.pv@epa.gov BASF Corporation EPA ha s received a pesticide petition, IN - 10843 , from BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27 709 , 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 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) , when used as an adjuvant inert ingredien t under 40 CFR 180.960 in pesticide formulation s . 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: N/A 2. Analytical method: N/A 3. Magnitude of residues: N/A B. Toxico logical 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). 1. 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methac rylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) is a polymer as defined by 40 CFR 723.250(b). In addition, 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 - amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 15158 72 - 09 - 9 ) 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. 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers andvinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) consists of a number average molecular weight greater than 2600 daltons, <10 % of its oligomeric material weighing below 500 daltons and 8.6 % of its oligomeric material we ighing less than 1,000 daltons. 3. 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone , tertBu 2 - ethylhexaneperoxoate - initiated, compds. with 2 - amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) 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 elemen ts 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 1 0 ,000 daltons. Additionally, the polymer, 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) 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. Thus, 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. No. 1515 872 - 09 - 9 ) 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 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 -C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds.

with 2 - amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 )

. C. Aggregate Expo sures For the purposes of assessing potential exposure under this exemption, 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexanepe roxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) 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 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) is greater than 2600 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 - amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) conform s to the criteria that identify a low risk polymer, there a re 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, whe n 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 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - init iated, compds. with 2 - amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) has a common mechanism of toxicity with other substances is not available. Since 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) meets the definition of a low concern polymer, 2 - Propenoic acid, 2 - methyl - , polymers wit h tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) is not expected to show any cumu lative effects. E. Determination of Safety 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 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate,polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tertBu 2 - ethylhexaneperoxoate - initiated, compds. with 2 - amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 )

. 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 postnata l 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 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tertBu 2 - ethylhexaneperoxoate - initiated, compds. with 2 - amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) based on the polymer meeting the definition of a low risk polymer un der 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 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) in or on crops or commodities at this time. G. Other Considerations 1. Endocrine Disruptors: There is no available evidence that 2 - Propenoic acid, 2 - methyl - , polymers with tert- Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16 - C18 - alkyl ethers and vinylpyrrolidone, tert- Bu 2 - ethylhexaneperoxoate - initiated, compds. with 2 -amino - 2 - methyl - 1 - propanol ( CAS Reg. N o. 1515872 - 09 - 9 ) is an endocrine disruptor.