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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 re place the instructions that appear in green , i.e., “ [ insert company

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

TEMPLATE:

Lamberti USA, Inc

I N

- 10807

EPA has received a pesticide petition ( IN

- 10807 ) from Spring Trading Company 10805 West Timberwagon Circle

, Sprin g , Texa s 7738 0 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, emulsifie rs, 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

.2

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 d a ta at this time or whether the data supports granting of the petition. Additional data may be needed befo re 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 identi f iable 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

expos ure, 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
tamar ind seed gum, 2

- hydroxypropyl e ther 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

approva l of defined low risk polymeric compounds.3

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 testin g 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 polymer s 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, sect ion 408 of the FFDCA directs E PA to consider available information concerning exposures from the pesticide residue in food
and all other non

- occupational exposures, including drinking water from ground water4

or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

E PA 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 e xposure 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

- te r m residential exposure and the Agency has determined that it is appropriate t o aggregate chro nic 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

Unl ike other pesticides for which E PA has followed a cumulative risk approach
based on a common mechanism of toxicity, E PA 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 a nd any other substances. The polymers of t amarind s eed g um, 2

- hydroxypropyl ether appear to produce no toxic metabolites produced by other substances

.

E. Safety Determination5

1. U.S. population. Based on these risk assessments, Lamberti USA, Inc.
conclu des 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 eth er 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

- hydroxyp ropyl 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.