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

EPA Petition Number: XXXXX

 EPA has received a pesticide petition, XXXXX, from BASF Corporation, 100 Campus 

Drive, 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 Acetic acid ethenyl, 

polymer with oxirane, CASRN: 25820-49-9, under 40 CFR 180.960 when used as an 

inert ingredient as a surfactant in pesticide formulations 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: 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. Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9 is a polymer 

as defined by 40 CFR 723.250(b). It is composed of at least 3 monomer units 

and 1 other reactant. In addition, Acetic acid ethenyl, polymer with oxirane, 

CASRN: 25820-49-9 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. Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9 consists of a 

number average molecular weight greater than 10,000 daltons, with <0.01 % of 

its oligomeric material weighing below 500 daltons and < 0.01 % of its oligomeric 

material weighing less than 1,000 daltons.

3. The polymer Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9, 

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 does contain as an integral part of its composition the atomic 

elements carbon, hydrogen, 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, Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9, 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, Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9 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 Acetic acid ethenyl, polymer with oxirane, CASRN: 

25820-49-9.

C. Aggregate Exposures

For the purposes of assessing potential exposure under this exemption, Acetic acid 

ethenyl, polymer with oxirane, CASRN: 25820-49-9 could be present in all raw and 

processed agricultural commodities and drinking water, and that non-occupational nondietary exposure was possible. The number average MW of Acetic acid ethenyl, polymer 

with oxirane, CASRN: 25820-49-9 is greater than 1,000 daltons. Generally, a polymer of 

this size would be poorly absorbed through the intact gastrointestinal tract or through 

intact human skin. Since Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9

conform 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 Acetic acid ethenyl, polymer with oxirane, 
CASRN: 25820-49-9 has a common mechanism of toxicity with other substances is not 

available. 

Since Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9 meets the 

definition of a low concern polymer, Acetic acid ethenyl, polymer with oxirane, CASRN: 

25820-49-9 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 Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9.

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 

Acetic acid ethenyl, polymer with oxirane, CASRN: 25820-49-9, 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, Acetic 

acid ethenyl, polymer with oxirane, CASRN: 25820-49-9 in or on crops or commodities 

at this time.

G. Other Considerations

1. Endocrine Disruptors: There is no available evidence that Acetic acid ethenyl, 

polymer with oxirane, CASRN: 25820-49-9 is an endocrine disruptor.