FILE NAME:   company.wpt   (7/1/2005) (xml)

Template Number P25	

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(1/1/2005)

EPA Registration Division contact: [Bipin Gandhi, 703-308-8380]

TEMPLATE:

960 to establish an exemption from the requirement of a tolerance for 



[2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers (No CASRN; EPA Accession No.
251695)] in or on the raw agricultural commodity [seeds]. EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408(d)(2) of the FFDCA; 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. Analytical chemistry: Lubrizol is petitioning that 2-propenoic,
2-methyl-, polymers with ethyl acrylate and polyethylene glycol
methylacrylate C18-22 alkyl ethers (No CASRN; EPA Accession No. 251695)
be exempt from the requirement of a tolerance based on the definition of
a low risk polymer under 40 CFR 723.250(e). Therefore, the analytical
method to determine residues of 2-propenoic, 2-methyl-, polymers with
ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl
ethers in raw agricultural commodities is not required.

	b. The polymeric substance is an acrylic copolymer latex, the product
of the polymerization of methacrylic acid, ethyl acrylate and PEG
behenyl ether methacrylate. The polymer is supplied as an aqueous
dispersion of approximately 30 wt% latex solids in water containing
sodium lauryl sulfate (0.4 wt%) as a surface-active agent.

	

.  [ As part of the EPA policy statement on inert ingredients published
in the Federal Register of April 22, 1987 (52 FR 13305), the Agency set
forth a list of studies that would generally be used to evaluate the
risks posed by the presence of an inert ingredient in a pesticide
formulation. However, where it can be determined without the data that
the inert ingredient will present minimal or no risk, the Agency
generally does not require some or all of the listed studies to rule on
the proposed tolerance, or exemption from the requirement of a
tolerance, for an inert ingredient. The established set of criteria for
polymers of low concern is described in 40 CFR 723.250 for polymers that
are relatively unreactive and stable compared to other chemical
substances. These properties generally limit the ability of a polymer to
cause adverse effects.  Lubrizol believes that the data and information
described below is adequate to ascertain the toxicology and characterize
the risk associated with the use of  the polymer 2-propenoic, 2-methyl-,
polymers with ethyl acrylate and polyethylene glycol methylacrylate
C18-22 alkyl ethers as an inert ingredient in pesticide formulations
applied to raw agricultural commodities (seeds). 

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers has been notified to the TSCA
Inventory and is listed as polymer exempt (XU) (EPA PMN No. P-03-216;
Accession No. 251695).

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers is not cationic.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers contains as an integral part
of its composition the atomic elements carbon, oxygen and hydrogen.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers does not contain as an
integral part of its composition, except as impurities, any elements
other than those listed in 40 CFR 723.250 (d) (2) (ii).

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers is not designed, nor is it
reasonably anticipated, to substantially degrade, decompose or
depolymerize.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers is not manufactured or
imported from monomers and/or other reactants that are not already on
the TSCA chemical substance inventory

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers is a water absorbing polymer.
However, this property was not considered a concern by the Agency.

The acrylic copolymer is a rheology modifier for use in aqueous
compositions. The polymer is manufactured using a water soluble
initiator in the emulsion polymerization reaction that yields an aqueous
latex dispersion at an approximate 30 wt% solids content. The polymer is
manufactured and only intended for commerce as an aqueous latex
dispersion. The manufactured polymer can not readily be rendered, or
used, in the form of a solid. Therefore, water swelling is not a concern
for the Agency.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers does not contain reactive
functional groups.

The polymer 2-propenoic, 2-methyl-, polymers with ethyl acrylate and
polyethylene glycol methylacrylate C18-22 alkyl ethers has a
number-average molecular weight of 94,600 Daltons (molecular weight
distribution 8,100 – 6,421,000 Daltons). Substances with molecular
weight greater than 400 generally are not absorbed through the intact
skin, and substances with molecular weights greater than 1000 generally
are not absorbed through the intact gastrointestinal tract. Chemicals
not absorbed through the skin or GI tract generally are incapable of
eliciting a toxic response.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl esters contains < 0.01 wt% oligomeric
material below molecular weight 500, and < 0.01 wt% oligomeric material
below 1000 molecular weight.

While not expected to be elicit systemic toxicity, the acrylic copolymer
2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene
glycol methylacrylate C18-22 alkyl ethers is known to be a mild dermal
and ocular irritant. Studies in rabbits resulted in a dermal Primary
Irritant Index score = 0.5 (mild irritant) and a maximum mean ocular
irritation score = 10.0 (scale 0 – 110; mild irritant). The irritation
study reports are submitted as a separate attachment to this submission.
This polymer would not contribute significantly to the irritation
potential of the end-use formulation.

It should be noted that many similar acrylic copolymers have been found
to be polymers of low concern and ruled to be low risk polymers by the
Agency.

Sodium lauryl sulfate (CASRN 151-21-3) is present in the commercial
mixture as a surface-active agent to a concentration of 0.4 wt%. The
surfactant (sodium lauryl sulfate) does not become an intrinsic part of
the polymer, rather it is absorbed onto the surface of the polymer
particles.

Sodium lauryl sulfate (CASRN 151-21-3) is listed as a food additive
permitted for direct addition to food for human consumption (21 CFR
172.822) and as a surface-active agent that may be safely used in the
manufacture of articles, or components of articles intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting or holding food (21 CFR 178.3400).

	

	

.  [The Agency has maintained that polymers meeting the polymer
exemption criteria will present minimal risk to human health when used
as inert ingredients in pesticide formulations applied to food crops.
EPA has also established exemptions from tolerance for polymeric
materials used as pesticide inerts that it considers to be intrinsically
safe based on the fact that they are listed on the TSCA Inventory or
meet the requirements of the amended TSCA polymer exemption. Exposure to
the final use dilution of 2-propenoic, 2-methyl-, polymers with ethyl
acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers 
when used as an inert ingredient in pesticide formulations is believed
to be inconsequential.

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