1 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

WA SHINGTON, D.C. 20460

**MEMORA NDUM**  **DA TE:**  July

17 , 2012 **SUBJECT:** Tier I Estimated Drinking Waters Concentrations of Fluazinam and its

Transformation Products for the Use in the Human Health Risk Assessment for the Registration of the New Uses on Peppers, Eggplant (Subgroup 8

- 10B) , Melons (Subgroup 9A) , and Soy beans ( **PC Code**  **129098 ;**  **DP Barcode s**  **D397602 , D402576**  ) **FROM:** José L . Meléndez, Chemist

Environmental Risk Branch 5 Environmental Fate and Effects Division (7507P) **THROUGH:** Mah T. Shamim, Ph.D., Chief

Environmental Risk Branch 5 Environmental Fate and Effects Division (7507P) **TO:** Tawanda Maignan , Risk Manager Reviewer

Tony Kish , Review Manager # 22 Cy nthia Giles

- Parker , Chief Fungicide Branch Andrew Ertman , Risk Manager Reviewer B arbara Madden, Review Manager # 0 5 Dan Rosenblatt, Chief Ris k Integration, Minor Use and Emergency Response Branch Registration Division (7505P) Douglas Dotson, Ph.D., Chemist Christina Swartz, Chief Registration Action Branch 2 Health Effects Division (7509P) This memorandum presents the Estimated Drinking Water Concentrations (EDWCs) for the py ridine fungicide fluazinam , and for its major transformation products DCPA, HYPA, CAPA, DAPA and AMPA , for use in the human health risk assessment. An IR

- 4 request for registration2

of various new crops was submitted to the Agency . These included the Cucurbits ( Melons ) Subgroup 9A and the Peppers/Eggplant Fruiting Vegetables Subgroup 8

- 10B

. Furthermore, the registrant submitted application for the use on so ybeans under Section 3 registration

. Based on a review of the use information, it was found that the proposed new crops have a lower seasonal application rates than the previously evaluated uses on turf. The maximum seasonal rates for the newly proposed crops is 4.68 lb a.i./A, compared to 8.4 lb a.i./A/season for turf ( DP Barcode D391184 ) ( **Table 1 -**  **2** ). EDWCs for the new uses should be smaller than those already calculated for turf; therefore, a new drinking water assessment (DWA) is not required. The values reported in the previous assessment can be used to cover the new crops. The last DWA is dated August 3, 2011 (assessment of the use on turf ; DP Barcode D391184 )

. The same DWA has a copy of the DWA dated February 24, 2010 a

ppended (uses on lettuce, apple s, carrot s and bulb vegetables, Crop Subgroup 3

- 07A ; DP Barcodes D360713, D365942 & D365948 )

. This DWA and attachment provide specific information about the chemicals modeled ( fluazinam, DCPA, HYPA, CAPA, DAPA and AMPA), structures, problem formulation and approac h taken in modeling the crops, a summary of phys icochemical and environmental fate properties of the chemicals , previous agricultural and turf uses, mode of action, anal ys is, uncertainties, characterization , etc
. EDWCs were calculated for total f luazinam residues because the environmental fate studies indicated that the parent compound undergoes transformation to compounds w ith a similar s tructure to the parent under most conditions [ as per the Metabolism Assessment Review Committee ( MARC ) request, DP Barco de D272624, W. Cutchin, 0 4/23/2001 ]

. The EDWCs summarized in **Table 1 -**  **1** represent upper
- bound estimates of the parent and degradates’ concentrations that might be found in surface water and groundwater due to the use of fluazinam on turf, as reported previ ously in DP Barcode D391184 . It is noted that this is still a screening

- level anal ys is and refinements are possible . Should any qu estions arise, please, contact the Environmental Fate and Effects Division (EFED )

. **Table 1 -**  **1 . Maximum Tier 1 Estimated**  **Drinking Water Concentrations (EDWCs) for drinking water assessment based on ground application of fluazinam on turf at a seasonal rate of 8.4 lb a.i./A**  Source/Model Fluazinam Total Residues of Fluazinam 1 Acute/ppb Chronic/ppb Acute/ppb Chronic/ppb Surface Waters/FIRST 217 2 1.47 226 2 37.8 Groundwater/SCI

- GROW 0.404 **1.** Including the following transformation products: DCPA, HYPA, CAPA, DAPA and AMPA. **2 .**  Exceeds the solubility of fluazinam at pH 7 (71 ppb), but not the solubility at pH 11 (350 ppm). 

### Background **and New Use Information**  As indicated above, new use s f or fluazinam have been requested b y the IR

- 4 Project and the registrant , ISK Biosciences Corporation , under Section 3 , on cucurbits (melons ) , fruiting vegetables (peppers / eggplant) , and so ybeans ( **Table 1 -**  **2** ) . It was found that the maximum seasonal application rate for the previousl y assessed use on turf (8.4 lb a.i./A/season) is much higher than for the new uses (4. 68 lb a.i./A/season).3

A summary

table of the newly

proposed use patt ern s is provided in **Table 1**  **- 2**  . This information is based on the proposed Supplemental L abel s for the product OMEGA ® 500F ( EPA Reg. No. 71512

- 1 ), which contains 40.0% a.i. or 4.17 lb a.i./gal of product. The product label claims that it is a broad spectrum fungicide for use to control diseases such as Downy Mildew, Alternaria Leaf Spot and Gummy S tem on cucurbit (melon) crops, Phy tophthora blight (

Phytophthora capsici) on peppers /eggplant , and white mold (Sclerotinia Sclerotiorum ) on soy beans

. **Table 1**  **- 2. Use information for fluazinam based on proposed**  **Supplemental L abel**  **s for**  **OMEGA ®**  **500F (EPA Reg. No. 71512 -**  **1)**

**USE MAX.**  **SINGLE APP. RATE**  **(lb. a.i./A) NUMBER** 

**OF APPS. AT MAX.**  **RATE SEASONAL** 

**APP. RATE**  **(lb. a.i./A) MINIMUM** 

**INTERVAL BETWEEN**  **APP S**  **. (days) APP.** 

**METHOD PHI** 

**(days) Cucurbit Vegetables, Melon**  **Subgroup 9A** ; Includes Citron m elon; Muskmelon, including hybrids and/or varieties of Cucumis melo (including true cantaloupe, cantaloupe, casaba, Santa Claus melon, Crenshaw melon, honeydew melon, honey balls, Persian melon, golden pershaw melon, mango melon, pineapple melon, snake melon); and watermelon, including hybrids and/or varieties of Citrullus spp. 0.78 6 4.68 7 Foliar **1** 30

**Fruiting Vegetable, Pepper/ Eggplant Subgroup 8**  **- 10B**  ; Includes African eggplant; bell pepper; eggplant; martynia; nonbell pepper; okra; pea; e ggplant; pepino; roselle; scarlet eggplant; cultivars, varieties, and/ or hybrids of these 0.78 6 4.68 7 Foliar **1,2** 30

**Soybeans** 0.52 2 1.04 10 Foliar NS **3 1**  Use sufficient water to provide coverage of foliage

. Aerial applications are not allowed for these crops. M ay be applied through sprinkler system irrigation equipment. **2** T he initial application may be made as a soil drench at transplanting

. **3** D o not apply after growth stage R3, early pod formation. 

### Data Gaps In previous review s , it was indicated that the environmental fate database for fluazinam is substantially

complete. It was stated that the terrestrial field dissipation and environmental chemistry methods/independent laboratory validations (ECMs/ILVs) were environmental fate data gaps. ISK Biosciences Corporation has submitted several studies which are currently being reviewed. They

will be evaluated and their suitability determined.4

835.6100: Terrestrial Field Dissipation

. Three terrestrial field dissipation studies were submitted (MRID#s 48361521, 48361522 & 48361523 ). Another relevant study include s a storage stability

study (MRID# 48361518). 835.6100, 835.6200: Environmental Chemistry Methods (ECMs) and Independent Laboratory Validations (ILVs) for Soil, W ater and Sediment

. The registrant submitted various method and validation studies (MRID#s 48361519, 48361520, 48361524 , 48632401, 48632402, 48635801 & 48635802 ). Finally , the registrant submitted a study which had not been previous ly required (MRID# 48361525). Despite being identified b y guideline number as an aquatic field dissipation study in the transmittal letter, it is an aerobic aquatic metabolism study

.