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

BASF Corporation

 EPA has received a pesticide petition, IN-10843, from BASF Corporation, 26 Davis 

Drive, Research Triangle Park, NC 27709, 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. 

No. 1515872-09-9), when used as an adjuvant inert ingredient under 40 CFR 180.960 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

1. Plant metabolism: N/A

2. Analytical method: N/A

3. Magnitude of residues: N/A

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).

1. 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-amino2-methyl-1-propanol (CAS Reg. No. 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. No. 1515872-09-9) 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 and 
vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compds. with 2-amino2-methyl-1-propanol (CAS Reg. No. 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 

weighing 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. No. 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 

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, 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-amino2-methyl-1-propanol (CAS Reg. No. 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. 1515872-09-9) 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. No. 1515872-09-9).

C. Aggregate Exposures

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-

ethylhexaneperoxoate-initiated, compds. with 2-amino-2-methyl-1-propanol (CAS Reg. 

No. 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. No. 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. No. 1515872-09-9) 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 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. 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. 

No. 1515872-09-9) meets the definition of a low concern 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. 

No. 1515872-09-9) is not expected to show any cumulative 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. No. 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 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 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. No. 1515872-09-9) 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 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. 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. No. 1515872-09-9) is an endocrine disruptor.