Document ID: EPA-HQ-OPP-2015-0350-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2016-04-25T04:00Z

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 replace 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 food 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  FFDCA; 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. [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 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. [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.]

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.  Diutan 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 no concern for genotoxicity based on data and the structural features of the compound.

	3. Reproductive and developmental toxicity. Diutan 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 to 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 based 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.    

      	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.  Based on a suitable analog, all margins of exposure are acceptable and below 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 certainty 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