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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-10807

EPA has received a pesticide petition (IN-10807) from Spring Trading Company

10805 West Timberwagon Circle, Spring, Texas 77380 on behalf of Lamberti USA,

Incorporated, 161 Washington Street Eight Tower Bridge, Suite 1000 Conshohocken, PA 

19428 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 under 40 CFR 180.960 for the polymers of tamarind 

seed gum, 2-hydroxypropyl ether or tamarind seed gum, 2-hydroxypropyl ether 

polymers having a number-average molecular weight >10,000 Daltons (CAS No. 68551-

04-2) used as dispersants, emulsifiers, surfactants, and related adjuvants of surfactants

in or on the raw agricultural commodity growing crops pre or post-harvest or in 

products to treat animals. 
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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. Waived under the polymer exemption definition.

2. 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.

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

B. Toxicological Profile

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 of tamarind seed gum, 2-hydroxypropyl ether or tamarind seed gum, 2-

hydroxypropyl ether 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 of tamarind seed gum, 2-hydroxypropyl ether or tamarind 

seed gum, 2-hydroxypropyl ether 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 of tamarind seed gum, 2-hydroxypropyl ether or 

tamarind seed gum, 2-hydroxypropyl ether 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.
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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 tamarind seed gum, 2-

hydroxypropyl ether polymers are carcinogenic.

6. Animal metabolism. Waived under the polymer exemption definition.

7. Metabolite toxicology. Waived under the polymer exemption definition.

8. 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 tamarind seed gum, 2-

hydroxypropyl ether or tamarind seed gum, 2- hydroxypropyl ether polymers 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

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 ground water 
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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 in 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 FPA 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 tamarind seed gum, 2-hydroxypropyl ether or tamarind seed

gum, 2-hydroxypropyl ether polymers 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 tamarind seed gum, 2-hydroxypropyl ether or tamarind seed gum, 2-

hydroxypropyl ether polymers.

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 tamarind seed gum, 2-hydroxypropyl ether or tamarind 

seed gum, 2-hydroxypropyl ether polymers with and any other substances. The 

polymers of tamarind seed gum, 2-hydroxypropyl ether appear to produce no toxic 

metabolites produced by other substances.

E. Safety Determination
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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 tamarind seed gum, 2-hydroxypropyl ether or tamarind seed gum, 2-

hydroxypropyl ether polymers.

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 tamarind seed gum, 2-hydroxypropyl ether or tamarind seed gum, 2-hydroxypropyl 

ether polymers.

F. International Tolerances

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

polymers of tamarind seed gum, 2-hydroxypropyl ether or tamarind seed gum, 2-

hydroxypropyl ether polymers nor have any CODEX Maximum Residue Levels been

established for any food crops at this time.