 

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (7/1/2006)

EPA Registration Division contact: [Pauline Wagner (703) 308-6164]

 

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document. 
Please do not remove or alter these comment notes or change the margins,
font, or format in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.]

TEMPLATE:

[Keller and Heckman LLP]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
[Keller and Heckman LLP], [1001 G Street, N.W., Suite 500 West,
Washington, DC 20001] 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

[1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate, CAS #
107568-12-7] in or on the raw agricultural commodity [all food
commodities] at [without numerical limitations] parts per million (ppm).
 EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of the 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.

	2. Analytical method. [NA - Remove]

	3. Magnitude of residues. [NA - Remove]

B. Toxicological Profile

	1. Acute toxicity.  [POLYMER EXEMPTION LANGUAGE

1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate is composed of
at least 3 monomer units and 1 other reactant.

1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate consists of a
simple weight majority of the polymer molecules.  The monomer
distribution in the polymer is completely random and the distribution of
the molecular weight of the polymer is due largely to the number of
monomer units in the individual molecules.

1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate will not
become cationic in an aquatic environment, and it contains no moieties
capable of obtaining a cationic charge. 

1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate is composed of
carbon, hydrogen, nitrogen, oxygen and sulfur, and therefore meets the
criteria of elemental composition.  Sodium exists as a monatomic
counterion.  

1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate will not
degrade, decompose or depolymerize.

All materials used to prepare 1-Propanesulfonic acid,
2-methyl-2-[(1-oxo-2-propenyl) amino]- monosodium salt, polymer with
ethenol and ethenyl acetate are on the TSCA Chemical Substance Inventory
or are manufactured under an applicable TSCA section 5 exemption.  

Although the number average molecular weight of 1-Propanesulfonic acid,
2-methyl-2-[(1-oxo-2-propenyl) amino]- monosodium salt, polymer with
ethenol and ethenyl acetate exceeds 10,000 and is hydrophilic, it does
not fit the definition of a water-absorbing polymer in that it does not
absorb its weight of water.  

	

- 	1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate consists of a
number average molecular weight of 55,370 with zero percent of its
oligomeric material weighing below 500 daltons and zero percent of its
oligomeric material weighing less than 1,000 daltons.]

	2. Genotoxicty. [NA - Remove]

	3. Reproductive and developmental toxicity. [NA - Remove]

	4. Subchronic toxicity. [NA - Remove]

	5. Chronic toxicity. [NA - Remove]

	6. Animal metabolism. [NA - Remove]

	7. Metabolite toxicology. [NA - Remove]

	8. Endocrine disruption. [NA - Remove]

C. Aggregate Exposure

	1. Dietary exposure. [The physical and chemical characteristics of
1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate leads to the
conclusion that there is a reasonable certainty of no harm from exposure
to the polymer from food or drinking water nor from an aggregate
exposure.]

	i. Food. [NA - Remove]

	ii. Drinking Food. [NA - Remove]

	2. Non-dietary exposure. [The physical and chemical characteristics of
1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate leads to the
conclusion that there is a reasonable certainty of no harm from exposure
to the polymer from non-dietary means.]

D. Cumulative Effects

	[At this time there is no information to indicate that any toxic
effects produced by 1-Propanesulfonic acid,
2-methyl-2-[(1-oxo-2-propenyl) amino]- monosodium salt, polymer with
ethenol and ethenyl acetate would be cumulative with any other chemical.
 Given the compound’s categorization as a low risk polymer, and its
proposed use in pesticide and anti-microbial formulations, there is no
expectation of increased risk due to cumulative exposure.]

E. Safety Determination

	1. U.S. population. [Based on the polymer’s physical and chemical
properties, and that it meets or exceeds the polymer exemption criteria
at 40 CFR 723.250 for low-risk polymers, adverse effects are not
expected.]

	2. Infants and children. [Based on the polymer’s physical and
chemical properties, and that it meets or exceeds the polymer exemption
criteria at 40 CFR 723.250 for low-risk polymers, adverse effects are
not expected.]

F. International Tolerances

	[There are no CODEX maximum residue limits established for
1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl) amino]-
monosodium salt, polymer with ethenol and ethenyl acetate in or on crops
or commodities at this time.]

