Document ID: EPA-HQ-OPP-2015-0718-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-11-23T05:00Z

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

     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).

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 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-amino-2-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, tert-Bu 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-amino-2-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, tert-Bu
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, tert-Bu
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.