Document ID: EPA-HQ-OPP-2014-0332-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-08-01T04:00Z

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

BASF Corporation

IN-10700

     EPA has received a pesticide petition, IN-10700, 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 2-Propenoic acid,
butyl ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1, under 40 CFR 180.960 when used as an inert  ingredient as
a binder polymer 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:  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).

2-Propenoic acid, butyl ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1 is a polymer as defined by 40 CFR 723.250(b).   In
addition, 2-Propenoic acid, butyl ester, polymer with
1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and
2-propenenitrile CASRN:  1469998-09-1 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, butyl ester, polymer with
1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and
2-propenenitrile CASRN:  1469998-09-1 consists of a number average
molecular weight greater than 10,000 daltons, 0.6 % of its oligomeric
material weighing below 500 daltons and 1.3 % of its oligomeric material
weighing less than 1,000 daltons.

3.  2-Propenoic acid, butyl ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1, 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 1,000 daltons. 
Additionally, the polymer, 2-Propenoic acid, butyl ester, polymer with
1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and
2-propenenitrile CASRN:  1469998-09-1, 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, butyl ester, polymer with
1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and
2-propenenitrile CASRN:  1469998-09-1 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, butyl
ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1.

C. Aggregate Exposures

 For the purposes of assessing potential exposure under this exemption,
2-Propenoic acid, butyl ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1 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, butyl
ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1 is greater 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 2-Propenoic acid, butyl ester,
polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1 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, butyl ester,
polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1 has a common mechanism of toxicity with other substances is
not available. 

Since 2-Propenoic acid, butyl ester, polymer with
1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and
2-propenenitrile CASRN:  1469998-09-1 meets the definition of a low
concern polymer, 2-Propenoic acid, butyl ester, polymer with
1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and
2-propenenitrile CASRN:  1469998-09-1 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, butyl ester, polymer with
1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and
2-propenenitrile CASRN:  1469998-09-1.

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, butyl
ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1, 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, butyl ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1 in or on crops or commodities at this time.

G. Other Considerations

1. Endocrine Disruptors:  There is no available evidence that
2-Propenoic acid, butyl ester, polymer with 1,6-diisocyanatohexane,
N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile CASRN: 
1469998-09-1 is an endocrine disruptor.