Document ID: EPA-HQ-OPP-2010-0429-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-06-23T04:00Z

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

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 non-dietary 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.