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OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

MEMORANDUM

DATE: 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 Soybeans

(PC Code 129098; DP Barcodes 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

Cynthia Giles-Parker, Chief

Fungicide Branch

Andrew Ertman, Risk Manager Reviewer

Barbara Madden, Review Manager #05

Dan Rosenblatt, Chief

Risk 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 

pyridine 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 registration 
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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 soybeans 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 appended (uses on lettuce, 

apples, carrots 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 approach taken in modeling the crops, a summary of physicochemical and 

environmental fate properties of the chemicals, previous agricultural and turf uses, mode of 

action, analysis, uncertainties, characterization, etc.

EDWCs were calculated for total fluazinam residues because the environmental fate studies 

indicated that the parent compound undergoes transformation to compounds with a similar 

structure to the parent under most conditions [as per the Metabolism Assessment Review 

Committee (MARC) request, DP Barcode D272624, W. Cutchin, 04/23/2001].

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 previously in DP Barcode D391184. It is noted that this is still 

a screening-level analysis and refinements are possible. Should any questions 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 Fluazinam1

Acute/ppb Chronic/ppb Acute/ppb Chronic/ppb

Surface Waters/FIRST 217 21.47 226 237.8

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 uses for fluazinam have been requested by the IR-4 Project and the 

registrant, ISK Biosciences Corporation, under Section 3, on cucurbits (melons), fruiting 

vegetables (peppers/eggplant), and soybeans (Table 1-2). It was found that the maximum 

seasonal application rate for the previously 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).
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A summary table of the newly proposed use patterns is provided in Table 1-2. This information 

is based on the proposed Supplemental Labels 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 Stem on cucurbit (melon) crops, Phytophthora blight (Phytophthora 

capsici) on peppers/eggplant, and white mold (Sclerotinia Sclerotiorum) on soybeans.

Table 1-2. Use information for fluazinam based on proposed Supplemental Labels 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 

APPS. (days)

APP.

METHOD

PHI

(days)

Cucurbit Vegetables, Melon 

Subgroup 9A; Includes Citron 

melon; 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 Foliar130

Fruiting Vegetable, Pepper/

Eggplant Subgroup 8-10B; 

Includes African eggplant; bell 

pepper; eggplant; martynia; 

nonbell pepper; okra; pea; 

eggplant; pepino; roselle; scarlet 

eggplant; cultivars, varieties, and/

or hybrids of these

0.78 6 4.68 7 Foliar1,2 30

Soybeans 0.52 2 1.04 10 Foliar NS3

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Use sufficient water to provide coverage of foliage. Aerial applications are not allowed for these crops. May be 

applied through sprinkler system irrigation equipment.

2 The initial application may be made as a soil drench at transplanting.

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Do not apply after growth stage R3, early pod formation.

Data Gaps

In previous reviews, 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.
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835.6100: Terrestrial Field Dissipation. Three terrestrial field dissipation studies were 

submitted (MRID#s 48361521, 48361522 & 48361523). Another relevant study includes a 

storage stability study (MRID# 48361518).

835.6100, 835.6200: Environmental Chemistry Methods (ECMs) and Independent Laboratory 

Validations (ILVs) for Soil, Water 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 previously required (MRID# 

48361525). Despite being identified by guideline number as an aquatic field dissipation study in 

the transmittal letter, it is an aerobic aquatic metabolism study.