UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

SUBJECT: 

TO: 

FROM: 

THRU: 

PC Code: 129098 

DP Barcode: D411177 

April 1, 2014 

Addendum to the Environmental Fate and Ecological Effects Preliminary 

Risk Assessment for the Registration Review of Fluazinam 

Eric Miederhoff, Chemical Review Manager 

Avivah Jakob, Team Leader 

Patricia Parrott, Chief 

Risk Management and Implementation Branch III 

Pesticide Reevaluation Division (7508P) 

1 

c{ 

Justin 

Jose L. 

Housenger, 

Melendez, 

Biologist 

Chemist ~ ~ 

/1._/1 ~ ~ 

Environmental Risk Branch V . . 2f 

Environmental Fate and Effects Division (7507P) 

Mah T. Shamim, Ph.D., Chief 

Environmental Risk Branch V 

Environmental Fate and Effects Division (7507P) 

This addendum revises the terrestrial risk assessment for the peanut and potato uses based on 

registrant submitted information as well as usage analysis conducted by the Biological and 

Economic Analysis Division on peanuts and potatoes. A background of the issue as well as 

revised risk charaterizarion follows. 

Basis for Revision of Terrestial RQs to Peanut and Potato Uses 

In the fluazinam PRA, T-REX was run using the default halflife of35 days because per EFED 

policy, crop-specific half life values can only be used for modeling all crops when halflife 

values are available from three or more crops. This policy is designed to prevent extrapolation 

of foliar halflife values from very limited data sets (i.e., 2 or fewer crops) because of the 

numerous factors that contribute to variability in foliar halflife values in the field (e.g., variation 

in rainfall, sunlight, temperature, application practices, wind speed, and crop characteristics. 

1 
Two foliar dissipation half-life studies were reviewed in 2008 for peanuts and potatoes (MRIDs 

46991302 and 46991303, respectively). Based on these two studies, fluazinarn residues dissipate 

from peanut and potato leaves at a rate faster than that assumed previously using the default halflife value of35 days with T-REX. As the studies were non-guideline, they were determined to 

be supplemental studies, with an estimated 90th percentile half life of7.33 days. The studies 

were determined to be suitable for quantitative risk assessment. Although the two available 

studies are still deemed insufficient for extrapolating half life across all applicable crops, they are 

considered sufficient for describing the foliar half lives for peanuts and potatoes. 

EFED, the Pesticide Re-evaluation Division (PRD) and the Biological and Economic Analysis 

Division (BEAD) investigated the extent to which the crops for which empirical half life data 

were available (peanut, potato) represent the major uses offluazinarn. 

In the subsequent BEAD memo titled, "Characterization of Use and Usage on Major Crops 

(Mainly Potatoes and Peanuts)," the usage of fluazinarn on various crops is described from its 

year of registration 2001 to 2012. Table 1 table below was extracted from this memo and 

provides a snapshot of the uses of fluazinarn in two different blocks of time. 

As Table 1 shows, between the years of2001-2006, nearly 100% offluazinarn usage was on 

peanuts and potatoes. This analysis serves to justify the use of the registrant submitted foliar 

dissipation half life studies for peanuts and potatoes as it is demonstrated that these uses account 

for the majority offluazinarn usage. For all other fluazinarn uses, the default 35-day foliar 

dissipation half life remains and no modification of terrestrial risk assessment for these crops are 

required per the previous PRA. 

Table 1. Comparison of Application Methods with Highest Use of Fluazinam- Percent of 

T t oa 1 Lb s. A •PPIIe r d b e tw een th e 2001 -2006 an d 2007 -2012 T" Ime f rames 

2001-2006 2007-2012 

A vg Annual Lbs A. I. Applied = 70,000 Av~ Annual Lbs A.l. Applied= 57,000 

Proportion Avg. A.I. Proportion Avg. A.I. of Total of Total 

Crop Lbs A.I. of Rate of #of Crop Lbs A.I. of Rate of #of 

Fluazinam Application Apps Fluazinam Application Apps 

Applied (lb a.i./acre) Applied (lb a.i./acre) 

Peanuts 17% 0.530 1.8 Peanuts 19% 0.532 1.4 

Potatoes 83% 0.231 2.4 Potatoes 69% 0.228 1.4 

Other* 12% 0.266-0.313 0.282-

0.313 

* Other crops include beans (snap, bush, pole, and string), dry beans/peas, and lima beans. 

Revised Terrestrial Animal Risk Assessment for Peanut and Potato 

Table 2 below shows in the revised input parameters for peanuts and potatoes use for modeling 

avian and mammalian risks from registered uses of fluazinarn on peanut and potato. 

2 
Table 2. Input Parameters for Deriving Screening-Level Terrestrial EECs for Labeled 

Uses ofFluazinam (T-REX v. 1.5.2). 

Single App Max No. of Min. Interval 

Uses Represented Rate AppsatMax Between Apps 

(lb a.i./A) Rate (days) 

Peanut 0.70 3 21 

Potato 0.261 7 7 

Tables 3 and 4 show the screening level dose and dietary based EECs for birds and mammals 

derived from T-REX (v.l.5.2). Within each table is a comparison ofthe EECs for peanuts and 

potatoes using the 35-day default foliar dissipation halflife (as was done in the PRA), and the 

lower halflife of7.33 derived from the registrant submitted studies. As shown in the tables, both 

dose and dietary-based EECs drop substantially under the assumption that fluazinam dissipates 

from terrestrial food items faster than the default value of 35 days. 

Table 3. Screening-level Dietary-based EECs (mglkg diet) as Food Residues for Birds, 

Reptiles, Terrestrial-phase Amphibians, and Mammals from Labeled Uses ofFluazinam 

T -REX v. 1.5.2). 

Primary Feeding Strategy ~ Herbivores, Omnivores, and Granivores Insectivores 

.., .., .... .;; .., Dietary Items 7 .., ~ '"CI • '"CI ~ .., 0 ~ '"' ~ ~ .., 0 

~ '"' -- c.'~~ c. ~ I C ~ .;; 0 

- '"CI ~ :l'"CI '"' '"' - ~- .c 0 'i ::=-- ·- ~ t: Use (Folair dissipation half-life) .J.. .c = ~ E-o = 00 r.. '"' .., < 

Peanut (35 days) 352 161 198 22 138 

Peanut (7.33 days) 194 89 109 12 76 

Potato (35 days) 301 138 169 19 118 

Potato (7.33 days) 128 58 72 8 50 

Values are m ppm. 

Acute and Chronic Diet-Based Risk Quotients 

Table 5 shows the acute dietary-based RQs for birds1

• Risk conclusions did not change with the 

use of the refined foliar dissipation half life of7.33 days since in the previous PRA, acute dietbased RQ values did not exceed the Agency acute risk LOC even with the larger (default) half 

life of 35 days. The RQs in Table 6 are presented with a"<" preceding them because they are 

estimated from a non-definitive endpoint ("greater than value) and therefore represent an upper 

bound (i.e., worst-case scenario) of risk. 

Table 6 shows the chronic-dietary based RQs for birds and mammals. In the previously PRA for 

the peanut and potato uses, the chronic LOC of 1 was exceeded for small birds consuming short 

grass. With the lower foliar dissipation half life value of7.33 days, the chronic risk LOC is no 

longer exceeded for any size/diet category. For mammals, the previous PRA indicated 

exceedence of chronic risk LOCs with potato and peanut uses for four groups of food items: 

short grass, tall grass, broadleafplants, and arthropods. Using the lower foliar dissipation half1 Acute, diet-based RQs are not derived for mammals due to lack of acute diet-based endpoints for this taxaon. 

3 
life value for peanuts, chronic, diet-based RQ values for two of the four groups of food items 

now are below the chronic risk LOC for mammals (arthropods and tall grass). For potatoes, 

chronic diet-based RQ values for three of the four groups of food items are now below the 

chronic risk LOC for mammals. 

Acute and Chronic Dose-Based Risk Quotients 

Acute dose-based RQs for birds and mammals are shown in Table 7. For both the peanut and 

potato uses, the previous PRA indicated that small birds consuming any of 4 contaminated food 

items and medium birds consuming one contaminated food item had RQs that exceeded the acute 

restricted use risk and endangered species LOCs. Using the refined foliar dissipation half life 

value with peanuts, acute dose-based RQs exceeded the acute endangered species risk LOC for 

two food items for small birds and no dose-based RQ values exceeded an acute risk LOC for 

medium birds. A similar trend was determined for potatoes, where RQs resulting from the refined 

foliar dissipation half life exceeded the acute endangered speices LOC only with small birds 

consuming short grass. There were no acute dose based RQs that exceeded the acute LOC for 

mammals before and after the shorter half life analysis. 

Finally, for chronic-based RQs for mammals, which represented the largest LOC exceedances for 

terrestrial organsisms in the PRA, risk determinations largely stayed the same with only large 

mammals eating arthropods dropping below the level of the chronic LOC of 1 for potatoes (Table 

8). All other food items that were above the level of the LOC, remained above the level despite 

RQs dropping by approximately 50%. Although some RQs represent a level of risk above the 

LOC, the percent crop treated for fluazinam is less than 2.5 percent for peanuts and 15 percent for 

potatoes, and therefore in spatial terms, this represents a small fraction of all potato and peanut 

acres treated. 

4 
Table 4. Screening-level Dose-based EECs (mg/kg bw) as Food Residues for Birds, Reptiles, Terrestrial-Phase Amphibians, 

---

Primary Feeding Herbivores and Omnivores Insectivores Granivores Strategy 7 

Animal Size 7 Small Med Large Small Med I Large Small I Med Large 

"' "' .... ,;; "' "' ,;; "' "' ,;; 

Dietary Items ~ "' '0 • "' .... '0 ~ "' .... '0 • ~ "' ~ 

8.~ ~ "' ~ ~ "' ~ J. ~ 8.~ 

i~ J. ~ .!!!l 8,'t J. ~ .!!!l c J. c J. c J. 

c ~ ,;; c '0 = ~ ,;; c '0 = ~ ,;; Arthropods Seeds, grains, etc. 

Use (Foliar .... - !l't:l t: ~ ~ !l't:l .... - ~ ~ !l't:l J. :; o- J. o- 0 '; ·-= ~ 0 -~ ·- ~ 0 '; -~ ·- ~ dissipation half- .c ~ = ~ = ~ E-< = J. "' .c E-< = J. "' .c E-< = J. "' 

life)..V ~ ~ ~ ~ ~ ~ 

Birds, Reptiles, and Terrestrial-phase amiphibians ! 

i 

Peanut (35 days) 401 184 225 25 229 105 129 14.3 102 47 57.6 6.4 157 89.5 40.1 5.6 3.2 1.4 ' 

Peanut (7.33 days) 221 101 124 13.8 126 57.8 71.0 7.88 56.5 25.9 31.8 3.53 86.6 49.4 22.1 3.07 1.75 0.78 

Potato (35 days) 343 157 193 21.4 195 89.5 110 12.2 87.4 40 49.2 3.5 134 76.5 34.2 4.6 2.7 1.21 

Potato (7.33 days) 146 66.9 82.1 9.12 83 .2 38.1 46.8 5.20 37.3 17.1 21.0 2.33 57.2 32.6 14.6 2.03 1.16 0.52 

Mammals 

Peanut (35 days) 336 154 189 21.0 232 106 130 14.5 53.78 24.7 30.3 3.36 131. 90.8 21.1 4.66 3.22 0.75 

Peanut (7.33 days) 185 84.9 104 11.6 128 58.7 72.0 8.00 29.7 13.6 16.7 1.85 72.5 50.1 11.6 2.57 1.78 0.41 

Potato (35 Days) 287 131 161 17.9 198 90.8 Ill 12.4 45.9 21.0 25.8 2.87 112 77.6 18.0 3.98 2.75 0.64 

Potato (7.33 days) 122 56.0 68.7 7.63 84.4 38.7 47.5 5.28 19.6 9.00 11.0 1.22 47.8 33.1 7.67 1.70 1.17 0.27 

1 Values are in mg a.i/kg-bw. 

5 
Table 5. Acute Dietary-Based RQs for Birds, Reptiles, and Terrestrial-phase Amphibians 

12 of Different Feeding Classes (T-REX v. 1.5.2). • 

Primary Feeding Strategy Herbivores, Omnivores, and Granivores Insectivores 7 

Dietary Items 7 

Short Tall Broad-leaf Fruits, pods, Arthropods 

Use (Foliar dissipation half- Grass Grass Plants seeds, etc. 

life) "" 

Peanut (35 days) <0.03 <0.02 <0.02 <0.01 <0.01 

Peanut (7.33 days) <0.02 <0.01 <0.01 <0.01 <0.01 

Potato (35 days) <0.03 <0.01 <0.02 .<0.01 <0.01 

Potato (7.33 days) <0.01 <0.01 <0.01 <0.01 <0.01 

1 Bolded and shaded cells mdtcate that the RQ exceeds an LOC for acute nsk to hsted and nonhsted btrds 2 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5 

Table 6. Chronic Dietary-Based RQs for Birds, Reptiles, Terrestrial-phase Amphibians, 

and Mammals of Different F Classes 1 

Primary Feeding Strategy 

7 

Dietary Items 7 

Use (Folair dissipation halflife) "" 

Short 

Grass 

Herbivores, Omnivores, and Granivores 

Tall 

Grass 

Broad-leaf 

Plants 

Fruits, pods, 

seeds, etc. 

Birds, Reptiles, and Terrestrial-phase amiphibians 

Peanut (35 days) 0.81 0.99 0.11 

Peanut (7.33 days) 0.45 0.55 0.06 

Potato (3 5 days) 0.69 0.85 0.09 

Potato (7.33 days) 0.29 0.36 0.04 

Mammals 

Peanut (3 5 days) 0.22 

Peanut (7.33 days) 0.12 

Potato (35 days) 0.19 

Potato (7.33 days) 0.08 

Insectivores 

Arthropods 

0.69 

0.38 

0.59 

0.25 

and · cells indicate that the RQ exceeds the LOC for chronic risk to listed and nonlisted birds and 

mammals (LOC = I). 

6 
Table 7. Acute Dose-based RQ values for Birds and Mammals Exposed to Fluazinam (T_lH"Y" 1 "'?\ 1•

2•3 

I D ....... n .. r .... .a..o.dh·uw I 

Herbivores and Omnivores Insectivores Granivores 

Med Lg Sm I Med I Lg Sm I Med I 

Dietary Items 7 I ~ ~ '; ~ ~ c; ~ ~ '; ~ c; ~ ~ '; ~ c; "" ~ ~ 0 'l:'t "" ~ ~ ~ 0 'l:'t - - ~ ~ .., 0 'l:'t ~;!) "" "i' C.."' ~;!) "" - C.."' ~;!) "" _ ... C.."' 

t: ~ ~ :f ~ .... ~ ~ :f ~ t: ~ ~ B :f ~ I Arthropods I Seeds, grains, etc. 

0 -; ~ ·= ~ ; -; ~ ·= ~ 0 -; ~ ~ ·= ~ Use(s) ~ I .c ~ ~ r.. ~ .c ~ ~ r.. ~ .c ~ ~ r.. ~ 00 ~ 00 ~ 00 ~ 

Birds, Reptiles, and Terrestrial-phase amiphibians --- Peanut (35 days) 0.06 0.08 0.01 0.04 0.02 0.02 <0.01 0.05 0.02 <0.01 <0.01 <0.01 

Peanut (7.33 days) 0.04 0.04 0.00 0.02 0.01 0.01 0.00 O.o3 0.01 0.00 0.00 0.00 

Potato (35 days) 0.05 O.o7 O.ot 0.04 0.02 0.02 <0.01 0.05 0.01 <0.01 <0.01 <0.01 

Potato (7.33 days) 0.02 0.03 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 <0.01 <0.01 <0.01 

Mammals 

Peanut (35 days) 0.04 0.02 0.02 <0.01 0.03 O.ot 0.02 <0.01 0.02 0.01 O.ot <0.01 0.01 0.01 0.01 <0.01 <0.01 <0.01 

Peanut (7.33 days) 0.02 0.01 0.01 <0.0 1 0.02 0.01 0.01 <0.01 0.01 <0.01 0.01 <0.01 0.01 0.01 <0.01 <0.01 <0.01 <0.01 

Potato (35 days) 0.03 0.01 0.02 <0.01 0.03 0.01 0.02 <0.01 0.01 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 <0.01 <0.01 

Potato (7.33 days) 0.01 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 O.ot <0.01 <0.01 <0.01 <0.01 <0.01 

and ~ cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted birds and mammals 

2Using adjusted LDso values of 1283, 1634, and 2308 for small, medium, and large birds, respectively and adjusted LDso values of9011, 7291, and 3154 for 

small, medium, and large mammals, respectively. 3 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5 

7 
Dietary Items 7 

Use(s) .J.-

Peanut (35 days) 

Peanut (7.33 days) 

Potato (3 5 days) 

.., 

.., 

f 

" t: 

~ 

.c 

00 

.., 

.., 

f 

" --; 

E-< 

Bolded and ~ cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted mammals. 2Using adjusted NOAEL values of23.30, 18.85, and 8.15 for small, medium, and large mammals, respectively. 3

Chronic risk LOC = I. 

8 

Arthropods Seeds, grains, etc. 

0.17 I 0.09 

0.09 I 0.05 

0.15 I 0.08 

0.06 I O.o3 
References 

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F. Korte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and 

Technology, Georg Thieme Publ, Stuttgart, West Germany, pp. 9-28. 

USEPA 1993. Wildlife Exposure Factors Handbook. EPA/600/R-13/187a. Office of Research 

and Development, Washington, D.C. 

USEPA 1998. Guidelines for Ecological Risk Assessment. EPA/630/R-95/002F. Published in 

63 FR 26846; May 14, 1998. U.S. Environmental Protection Agency, Washington, DC. 

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USEP A 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide 

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9