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**EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER**  **EPA Registration**  **Division contact: [**  **Mark Dow (703) 305 -**  **5533 ]**  **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:**  **[ CP Kelco**  **U.S., Inc. ]**  **[ IN**  **- 10815**  **]** EPA has received a pesticide petition **( IN**  **- 10815**  **)** from **CP Kelco U**  **. S**  **. , Inc.,**  **3100 Cumberland Blvd., Ste. 600**  **, Atlanta, GA 30339**  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. 910 and part 180.940 **to establish an exemption from the requirement of a**  **tolerance for D**  **- glucurono**  **- 6**  **- deoxy** **- L**  **- manno**  **- D**  **- glucan, acetate, calcium**  **, magnesium**  **, potassium**  **, sodium salt**  **(diutan gum) with the Chemical Abstracts**  **Service Registry Number 595585 -**  **15 -**  **2 when present at up to 1.5% in pesticide**  **formulations that may be used for f ood or non**  **- food applications.**  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of F F DCA; however, EPA has not fully evaluated the sufficiency of the submitted d ata 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. [N/

A
- Remove. No specific plant metabolism data is available, nor is it required for the establishment of a tolerance exemption.] 2. Analytical method. [N/A
- Remove. An anal ytical method is not required for enforcement purposes since the Agency is establishing an exemption from th e requirement of a tolerance without any numerical limitatio n. ] 3. Magnitude of residues. [N/A
- Remove. Information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required for the establishment of a tolerance exemption .]2

**B. Toxicological Profile**  1. Acute toxicity. **Diutan gum is of low acute toxicity via the oral route. Dermal toxicity**  **is not expected .**  **An acute inhalation study in rats showed effects that were seen in both the test and control animals to a similar extent, and therefore**  **cannot be attributed to diutan gum. D**  **iutan gum is considered to be slightly irritating to the eyes. Diutan gum**  **is not**  **expected to be a skin irritant. Diutan gum is not a skin sensitizer**  **based on test results .**  2. Genotoxicty. **There is n o concern for genotoxicity based on data and the**  **structural features of the compound.** 3. Reproductive and developmental toxicity. **Diut an gum is not**  **expected to be a**  **reproductive and developmental toxicant**  **based on its low toxicity in subchronic**  **tests and the structural features of the compound.**  4. Subchronic toxicity. **Diutan gum was tested for Repeated Dose 28 -**  **day Oral Toxicity Study in Rats/Sprague**  **- Dawley (5/sex) by oral gavage (doses: 0, 150, 500,**  **1000 mg/kg bw/day) per OECD TG 407. The NOEL was 1000 mg/kg bw/day.** 5. Chronic toxicity. **Diutan gum is not expected t**  **o exhibit chronic toxicity based on its low toxicity in subchronic tests and the structural features of the**  **compound .**  **.** 6. Animal metabolism. **Based on a study on a similar compound,** the **majority of the polysaccharide fraction**  **is expected to be excreted unhydrolyzed. Up to 15%**  **of the non -**  **polysaccharide fraction may be**  **absorbed.** 7. Metabolite toxicology
. **[**N/A
- Remove **.]** 8. Endocrine disruption
. **No concern is noted for endocrine effects**  **based on data and/or the structural features of the**  **compound.**

**C. Aggregate Exposure**  1. Dietary exposure. **The evaluation**  **of dietary exposure was b**  **ased on modeling with**  **the assumption of 100% crop treated, a sub**  **- chronic**  **endpoint and**  **safety factors of intraspecies variability (10x)**  **, animal to**  **human variability (10x) ,**  **uncertainty from a repeated dose study to a chronic study (10x)**  **and sensitivity with regard to infants and children**  **( 10x** **) to arrive at an overall uncertainty factor for the compound is**  **10,000. While dietary exposure may**  **result from the use of diutan gum as an inert ingredient in pesticide formulations applied to growing crops or**  **to raw agricultural commodities after harvest, the potential for exposure**  **is below levels of concern.** 3
i. Food. [N/A

– Remove ] ii. Drinking water. [N/A

– Remove ] 2. Non
- dietary exposure
. **The term “residential exposure” is used in this document to refer to non**  **- occupational, non**  **- dietary exposure (e.g., textiles**  **(clothing and diapers) , carpets, swimming polls, and hard surface**  **disinfection on walls, floors, and tables). There is a potential for residential exposure to pesticide products**  **containing diutan gum . B**  **ased on a suitable analog, all margins of exposure**  **are acceptable**  **and be low levels of concern**  **. D. Cumulative Effects**  **EPA has not**  **found diutan gum to share a common**  **mechanism of toxicity with any other substances, and diutan gum does not produce**  **a toxic metabolite. With respect to this petition,**  **cumulative exposures**  **were sufficiently considered in**  **the range of assumptions used to assess exposure from use on**  **crops and**  **household products and no adverse cumulative effects were identified**  **. E. Safety Determination**  1. U.S. population. **Based on the risk assessments**  **described above , there is a**  **reasonable certainty that no harm will result to the general population from aggregate exposure to residues of diutan gum.**  2. Infants and children
. **Based on these risk assessments described above there is a reasonable cert**  **ainty that no harm will result to infants and children from aggregate exposure to residues of diutan gum.** 
**F. International Tolerances CP Kelco is not aware of any country requiring a**  **tolerance for the petitioned substance nor have any CODEX Maximum Residue**  **Levels been established for any food crops at this time.**

**4820 -**  **8011 -**  **1138, v. 1**