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 Housenger, Biologist 

# /1._/1

# ~ Jose L. 

### Melendez, Chemist

# ~**~ ~**  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 ofthe 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 offoliar halflife values from very limited data sets (i.e., 

### 2 or fewer crops) because ofthe 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.
1Two 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 ofregistration 2001 to 2012. 

### Table 1 table below was extracted from this memo and provides a snapshot ofthe uses of fluazinarn in two different blocks oftime. 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 ofthe 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 ofterrestrial 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 1

### Lb A 

## r d b tw 

### th 2001 2006 d 2007 2012 T" 

### f

oa s. •PPIIe e een e 

# - an 

# - Ime rames 2001-2006 2007-2012 Avg 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 offluazinarn on peanut and potato.

2Table 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 birds 1 • Risk conclusions did not change with the use ofthe 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) ofrisk. 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 offood 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 ofthe four groups offood items now are below the chronic risk LOC for mammals (arthropods and tall grass). For potatoes, chronic diet-based RQ values for three ofthe four groups offood 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 ofthe 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.~**~** 

### "'**~ ~**  

### "'**~**

### 8.~ J.**~**

# 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 2Acute 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 ofDifferent 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. 3Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0
.5

7Dietary 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. 3Chronic 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 Fletcher, J.S., J.E. Nellessen, and T.G. P:fleeger. 1994. Literature review and evaluation ofthe EPA food-chain (Kenaga) nomogram, and instrument for estimating pesticide residues on plants. Environmental Toxicology and Chemistry 13 (9):1383-1391. Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation ofrepresentative data as a basis for estimation oftheir magnitude in the environment. In F. Coulston and 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. April, 1998. USEPA 2004. Overview ofthe Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental" Protection Agency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D.C. Available online at 

### http:/lwww.**~pa.** 

### gov/ oppfoadl Iendanger/consultation/ ecorisk-overview.pdf.



### 9