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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: William Cutchin, 703-305-7990

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element does not apply, please insert “NA-Remove” and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert 

company name],” with the information specific to your action.

TEMPLATE:

Lamberti USA, Inc.

IN-10836

EPA has received a pesticide petition (IN-10836) from Spring Trading Company, 

203 Dogwood Trail, Magnolia, Texas 77354-5201 on behalf of Lamberti USA, Inc., 

14622 Exxon Road, Conroe, Texas 77302, 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 the polymer 

2-propenoic acid homopolymer, reaction products with Poly(oxy-1,2-ethanediyl), a-

(tris(l-phenylethyl)phenyl)-w-hydroxy, Tris(2-Hydroxyethyl)Amine salt) having an 

average molecular weight of greater than 10,000 Daltons, used for dispersants, 

emulsifiers, surfactants and related adjuvants of surfactants (CAS# 1477613-46-9) 

under 40 CFR 180.960 when used growing crops pre or postharvest or in products to 

treat animals.

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 Waived under the polymer exemption definition.

1. Analytical method. An analytical method is not required for enforcement

purposes since the Agency is establishing an exemption from the requirement of a

tolerance without any numerical limitation.

2. Magnitude of residues. Waived under the polymer exemption definition.

B. Toxicological Profile
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Lamberti USA, Inc. has reviewed the available toxicity data and considered its

validity, completeness, and reliability as well as the relationship of the results of the

studies to human risk. Lamberti USA, Inc. has also considered available information

concerning the variability of the sensitivities of major identifiable subgroups of

consumers, including infants and children for the low risk polymer classification. These 

polymers are not acutely toxic by the oral and dermal routes of exposure, or via 

inhalation under normal use conditions. Concentrated materials are generally not

corrosive, eye and skin irritants and not dermal sensitizers. There is no evidence that

these polymers are neurotoxic, mutagenic, or clastogenic.

Specific information on the studies evaluated and the nature of the adverse effects

findings by the agency for the polymers as well as the no-observed-adverse-effect level

(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity

studies can be found at http://www.regulations.gov in documents allowing the approval 

of defined low risk polymeric compounds.

1. Acute toxicity. Waived under the polymer exemption definition.

2. Genotoxicty. Waived under the polymer exemption definition.

3. Reproductive and developmental toxicity. Waived under the polymer

exemption definition.

4. Subchronic toxicity. Waived under the polymer exemption definition.

5. Chronic toxicity. There is no evidence that 2-propenoic acid homopolymer, 

reaction products with Poly(oxy-l,2-ethanediyl), a-(tris(l-phenylethyl)phenyl)-w-hydroxy,

Tris(2-Hydroxyethyl)Amine salt) are carcinogenic.

6. Endocrine disruption. FQPA requires EPA to develop a screening program to 

determine whether certain substances, including all pesticide chemicals (both inert and 

active ingredients), "may have an effect in humans that is similar to an effect produced by 

a naturally occurring estrogen, or such other endocrine effect. .EPA has been working 

with interested stakeholders to develop a screening and testing program as well as a 

priority setting scheme. As the Agency proceeds with implementation of this program, 

further testing of products containing the polymers of 2-propenoic acid homopolymer, 

reaction products with PoIy(oxy-l,2-ethanediyl), a-|tris(l-phenylethyl)phenyl)-w-hydroxy, 

Tris(2-Hydroxyethyl)Amine salt) for endocrine effects may be required. This class of 

chemistry does not belong to a class of chemicals known or suspected of having adverse 

effects on the estrogen receptor or endocrine system.

C. Aggregate Exposure

1. Dietary exposure. In examining aggregate exposure, section 408 of the FFDCA 

directs EPA to consider available information concerning exposures from the pesticide 

residue in food and all other non-occupational exposures, including drinking water from 
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ground water or surface water and exposure through pesticide use in gardens, lawns, or 

buildings (residential and other indoor uses).

EPA establishes exemptions from the requirement of a tolerance only in those

cases where it can be demonstrated that the risks from aggregate exposure to pesticide

chemical residues under reasonably foreseeable circumstances will pose no appreciable 

risks to human health. In order to determine the risks from aggregate exposure to 

pesticide inert ingredients, the Agency considers the toxicity of the inert ill conjunction 

with possible exposure to residues of the inert ingredient through food, drinking water, 

and through other exposures that occur as a result of pesticide use in residential settings. 

If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a 

reasonable certainty that no harm will result from aggregate exposure to the inert 

ingredient, an exemption from the requirement of a tolerance may be established.

The polymers of 2-propenoic acid homopolymer, reaction products with

Poly(oxy-l,2-ethanediyl),a-[tris(l-phenylethyl)phenyl)-w-hydroxy,Tris(2-

Hydroxyethyl)Amine salt) proposed use as inert ingredients in pesticide products that are 

currently registered for uses that could result in intermediate-term residential exposure 

and the Agency has determined that it is appropriate to aggregate chronic exposure 

through food and water with intermediate-term residential exposures to the polymers of 

2-propenoic acid homopolymer, reaction products with Poly(oxy-1,2-ethanediyl), a-

|tris(l-phenylethyl)phenyl)-w-hydroxy, Tris(2-Hydroxyethyl)Amine salt).

D. Cumulative Effects

Unlike other pesticides for which EPA has followed a cumulative risk approach 

based on a common mechanism of toxicity', EPA has not made a common mechanism of 

safety finding as to polymers of 2-propenoic acid homopolymer, reaction products with 

Poly(oxy-l,2-ethanediyl), a-(tris(l-phenylethyl)phenyl)-w-hydroxy, Tris(2-

Hydroxyethyl)Amine salt) with and any other substances.

E. Safety Determination

1. U.S. population. Based on these risk assessments, Lamberti USA, Inc. 

concludes that there is a reasonable certainty that no harm will result to the general 

population or to infants and children from aggregate exposure to residues of the polymers 

of 2- propenoic acid homopolymer, reaction products with Poly(oxy-l,2-ethanediyl), a-

(tris(l-phenylethyl)phenyl)-w-hydroxy, Tris(2-Hydroxyethyl)Amine salt).

2. Infants and children. Based on these risk assessments, Lamberti USA, Inc.

concludes that there is a reasonable certainty that no harm will result to the general

population or to infants and children from aggregate exposure to residues of polymers of 

2-propenoic acid homopolymer, reaction products with Poly(oxy-l,2-ethanediyl), a-(tris(l 

-phenylethyl)phenyl)-w-hydroxy, Tris(2-Hydroxyethyl)Amine salt).

F. International Tolerances
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Lamberti USA, Inc. is not aware of any country requiring a tolerance for the

polymers of 2-propenoic acid homopolymer, reaction products with Poly(oxy-l,2-

ethanediyl), a-(tris(l-phenylethyl)phenyl)-w-hydroxy, Tris(2-Hydroxyethyl)Amine salt) 

nor have any CODEX Maximum Residue Levels been established for any food crops at 

this time.