UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460



### MEMORANDUM OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION



### PC Code: 129098

DP Barcode: D411177

June 4, 2013

SUBJECT: Environmental Fate and Ecological Effects Preliminary Risk Assessment for

the Registration Review of Fluazinam

TO: Steven Snyderman, Chemical Review Manager

A vivah Jakob, Team Leader

Patricia Parrott, Chief

Risk Management and Implementation Branch III

Pesticide Reevaluation Division (7508P)



### FROM: Jose 

### L. Melendez, Chemist 

# K**~** Justin Housenger, Biologist 

# Q 

# >

Environmental Risk Branch V 

# (/V""

Environmental Fate and Effects Division (7507P)



### THRU: Lr-41ah T. Shamim, Ph.D., Chief

# ~ /Jv· ·

# ~(**~~** /t" Environmental Risk Branch V c)

# ~oro"~ 

# ltJ

Environmental Fate and Effects Division (7507P)

The Environmental Fate and Effects Division completed the environmental fate and ecological

effects risk assessment for the Registration Review of the active ingredient fluazinam (PC Code 129098). The assessment concludes that birds, mammals, freshwater and estuarine / marine fish,
invertebrates, and sediment-dwelling organisms, and aquatic plants on the target areas may be adversely affected by the registered uses of fluazinam. Adverse effects in mammals and birds following chronic exposure to fluazinam, in laboratory studies include reductions in growth and

in offspring fitness and viability. Fluazinam has a relatively high propensity to bind to sediment

and has been shown to bioconcentrate in fish. However, a preliminary analysis shows that acute

and chronic risk to birds and mammals consuming fish exposed to fluazinam is below levels of

concern, presumably based on fluazinam's readiness to depurate rapidly from tissues.

1

### `



# Preliminary Environmental Fate and Ecological Risk

Assessment for the Registration Review of Fluazinam

CAS 079622

- 59

- 6

PC Code 129098

DP Barcode D 411177



### June 4

, 2013

Prepared b y José L. Meléndez, Chemist Justin Housenger

, Biologist U.S. Environmental Protection Agency Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch V 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 

### Reviewed by Keith Sappington, Senior Science Advisor Mohammed Ruhman, Ph.D., Senior Agronomist

Mah T. Shamim

, Ph.D., Branch Chief 

# N F F

F Cl

N H

O 2 

# N O 2 

# N Cl

F F F- Page 2 of 137

- 

# Table of Contents

1. Executive Summary

................................ ................................ ................................ ................................ ........... 4

2. Problem Formulation

................................ ................................ ................................ ................................ .. 5

2.1. Nature of Regulatory Action

................................ ................................ ................................ .................... 5

2.2. Stressor Source and Distribution

................................ ................................ ................................ ............ 5

2.2.1. Nature of the Chemical Stressor

................................ ................................ ................................ ........... 5

2.2.2. Overview of Pesticide Usage

................................ ................................ ................................ ............. 7 2.3. Receptors

................................ ................................ ................................ ................................ .................. 7

2.3.1. Aquatic and Terrestrial Effects

................................ ................................ ................................ ........ 7 2.3.2. Ecosystems Potentially at Risk

................................ ................................ ................................ ........ 9

2.4. Assessment Endpoints

................................ ................................ ................................ .............................. 9 2.5. Conceptual Model

................................ ................................ ................................ ................................ ..... 9 2.5.1. Risk Hypotheses

................................ ................................ ................................ ................................ 10 2.5.2. Conceptual Diagram

................................ ................................ ................................ ......................... 10 2.6. Analysis Plan

................................ ................................ ................................ ................................ ........... 13 2.6.1. Measures of Exposure

................................ ................................ ................................ .................... 13

2.6.2. Measures of Effect

................................ ................................ ................................ .......................... 15 2.6.3. Integration of Exposure and Effects

................................ ................................ ............................. 15

3. Analysis

................................ ................................ ................................ ................................ ............................. 17

3.1 Use Characterization

................................ ................................ ................................ ................................ ... 17

3.2. Exp osure Characterization

................................ ................................ ................................ .................... 22

3.2.1. Environmental Fate and Transport Characterization

................................ ................................ . 22

3.2.2. Measures of Aquatic Exposure

................................ ................................ ................................ ....... 31

3.2.3. Measures of Terrestrial Exposure

................................ ................................ ................................ .. 38

3.3. Ecological Effects Characterization

................................ ................................ ................................ ...... 45

3.3.1. Aquatic Toxicity Assessment

................................ ................................ ................................ .......... 46

3.3.2. Terrestrial Effects Characterization

................................ ................................ .............................. 53

3.3.3. Estimates of Degradate Toxicity

................................ ................................ ................................ .... 59

3.3.4. Review of Incident Data

................................ ................................ ................................ .................. 60

4. Risk Characterization

................................ ................................ ................................ ................................ ...... 60

4.1. Screening

- Level Risk Quotient (RQ) Values

................................ ................................ ........................ 60

4.1.1. RQ Values for Aquatic Organisms

................................ ................................ ................................ 61

4.1.2. RQ Values for Sediment

- Dwelling Organisms

................................ ................................ .............. 69

4.1.3. RQ Values for Terrestrial Organisms

................................ ................................ ........................... 73 4.1.4. Bioaccumulation Analysis Results

................................ ................................ ................................ ....... 82

4.2. Risk Description

................................ ................................ ................................ ................................ ...... 83

4.2.1. Risks to Aquatic Organisms

................................ ................................ ................................ ........... 83

4.2.2. Risks to Terrestrial Organisms

................................ ................................ ................................ ...... 89

8. Uncertainties, Limitations, and Identification of Data Gaps

................................ ................................ ...... 101

8.1. Environmental Fate

................................ ................................ ................................ ................................ ..... 101

8.1.1. Data Gaps Uncertainties

................................ ................................ ................................ ............... 101

8.1.2. Maximum Use Scenario

................................ ................................ ................................ ................ 101

8.1.3. Aquatic Modeling with PRZM/EXAMS

................................ ................................ ...................... 102

8.1.4. Buffer Zone to Estuarine/Marine Bodies of Water

................................ ................................ .... 103

8.1.5. Uncertainties regarding dilution and chemical transformat ions in estuaries

.......................... 103 8.2. Ecological Effects

................................ ................................ ................................ ................................ ......... 104 8.2.1. Terrestrial Exposure Assessment

................................ ................................ ................................ ....... 105 8.2.2. Routes of Exposure

................................ ................................ ................................ ............................. 106 8.2.3. Age Class and Sensitivity of Effects Thresholds

................................ ................................ ................ 106- Page 3 of 137

- 8.2.4. Lack of Effects Data for Amphibians and Reptiles

................................ ................................ .......... 106 8.2.5. Use of the Most Sensitive Species Tested

................................ ................................ ........................... 107

8.2.7. Sublethal Effects

................................ ................................ ................................ ................................ ... 109

8.2.8. Ecological Effects Data Gaps

................................ ................................ ................................ .............. 109

9. References

................................ ................................ ................................ ................................ ....................... 109



## Appendices

Appendix A. PRZM/EXAMS Sample Input/Output Data

................................ ................................ .................. 116 Appendix B. Example T

- REX (v. 1.5.1) Input and Output for Fluazinam

................................ ........................ 122 Appendix C. Example Terrplant (v. 1.2.2) Input and Output for Fluazinam

................................ ................... 126 Appendix D. STIR Results.

................................ ................................ ................................ ................................ .... 126 Appe ndix E. SIP Results.

................................ ................................ ................................ ................................ ....... 128 Appendix F. Classifications of Environmental Fate Studies Submitted for Fluazinam

................................ ... 129 Appendix G. Classifications of Ecological Effects Studies Cited in the Risk Assessment for Fluazinam

....... 133 Appendix H. KABAM Output

................................ ................................ ................................ ............................... 135- Page 4 of 137

- 

## 1. Executive Summary

Th e preliminary risk assessment (PRA) examines the potential ecolo gical risks

associated with labeled uses of the contact fungicide fluazinam [ 3

- chloro

- N

- (3

- chloro

- 5

- trifluoromethyl

- 2

- pyridyl)

- α,α,α

- trifluoro

- 2,6

- dinitro

- p

- toluidine ], based on
the best available scientific and commercial information on the use, environmental fate and transport, and effects of fluazinam on non

- target or ganisms

.

The screening level assessment concludes that the use of fluazinam , a pyridine (dinitroaniline)

, in accordance with registered labels results in acute and chronic

risk to birds, chronic risk to mammals, acute and chronic risk to freshwater fish, estuarine/marine invertebrates, and freshwater and estuarine/marine benthic invertebrates, acute risk to freshwater invertebrates and estuarine/marine fish, and

risk to listed and non

- listed species of aquatic plants that exceed s the Agency’s

Level of Concern (LOC). Adverse effects in mammals and birds following chronic exposure to fluazinam in laboratory studies include reductions in growth and in offspring fitness and viability; these effe cts are seen across generations

. Some

uses of fluazinam ma y result in chronic risk to mammals and acute and chronic

risk s to birds , reptiles, and terrestrial

- phase amphibians exposed to fluazinam in

the diet.

Expected o ff

- site transport of fluazinam to surface water presents risk to listed and

non

- listed species of aquatic nonvascular plants ( e.g ., algae) ; it is uncertain to what degree algicidal or algistatic effects i n the aquatic plant community may result in indirect effects to organisms consuming algae

. While available data suggest that

fluazinam is practically non

- toxic to bees, screening level RQs indicate that some

uses of fluazinam do result in the exceedance of the interim LOC for terrestrial

invertebrates.

Fluazinam (with its moderately high K OC 

### ) has a relatively high propensity to bind to

sediment s . A screening level analysis has shown fluazinam to pose chronic risk above the LOC in both the pore water and sediment compartments. Additionally, fluazinam is shown to bioconcentrate in fish thus suggesting a route of exposure to

birds and mam mals that could consume fluazinam contaminated fish. However, a preliminary analysis shows that acute and chronic risk to birds and mammals consuming fish exposed to fluazinam is below levels of concern, presumably based on fluazinam’s readiness to depura te rapidly from tissues.- Page 5 of 137

- 

## 2 . Problem Formulation

The purpose of problem formulation is to provide the foundation for the environmental fate and ecological risk assessment being conducted for the labeled uses of fluazi na m
, as shown in the two approved labels for this chemical ( EPA Reg. Nos. 71512

- 1 and 71512

- 20)

. The problem

formulation sets the obje ctives for the risk assessment and provides a plan for analyzing the data and characterizing the risk ( USEPA 1998 a ). As part of the Registration Review process, a detailed Problem Formulation (DP Barcode D362189 ) for this risk assessment was published to the docket [ Docket ID: EPA

- HQ

- OPP

- 200 9

- 0039 ] in September 2009 . The following section summarizes the key points of th at document and discusses any differences between the analysis

outlined there and the analysis conducted in this risk assessment.

2.1

. Nature of Regulatory Action

The risk assessment is con ducted as part of the Agency’s Registration R eview process for

pes ticide active ingredients. The Registration Review process was established under the Fo od Quality Protection Act (FQPA 1995).

2.2

. Stressor Source and Distribution

2.2. 1. Nature of the Chemical Stressor

Fluazinam, CAS Name: 3

- chloro

- N

- [3

- chloro

- 2,6

- dinitro

- 4

- (trifluoromethyl)phenyl]

- 5

- (trifluo

romethyl)

- 2

- pyridinamine, and IUPAC Name: 3

- chloro

- N

- (3

- chloro

- 5

- trifluoromethyl

- 2

- pyridyl)

- α,α,α

- trifluoro

- 2,6

- dinitro

- p

- toluidine, has a CAS Number of 79622

- 59

- 61 and a PC

Code of 129098. It is a pyridine (dinitroaniline) fungicide. The structure consists of one phenyl ring with two nitro groups, and a pyridine ring. Both rings have a trifluoromethyl group. The rings are attached by an amine group.

Fluazinam is a protectant and contact fu ngicide. According to the Fungicide Resistance Action Committee (FRAC , available at http://www.frac.info/ accessed 04/25/2013 ) classification scheme of fungicides, fluazinam belongs to the chemical group of 2,6

- dinitroa nilines and is classified as FRAC numerical code 29, according to the mode of action, which is inhibition of

cellular respiration. Fluazinam is an uncoupler of oxidative phosphorylation in the respiration chain involving protonation/d eprotonation (thereby inhibiting the production of energy within the fungus). Fluazinam belongs to a chemical group classified as a multi

- site fungicide (chemicals which act as general toxophores with several sites of action).

The chemical profile of fl uazinam is provided in Table 2. 1

. Table 3.4 lists c hemical names a nd

structures of the degradates, as they were observed to be major products in submitted

environmental fate s tudies

. The table shows the chemical structures of fluazinam and its eight major transformation products (CAPA, DCPA, HYPA, DAPA, AMPA, G

- 504, MAPA, and

SDS

- 67200). It is noted that all these transformation products (except for G

- 504, which is a tricyclic compound) are structurally very similar to the parent compound ( i.e. , they have the

same backbone structure with slight differences in the ring moieties ). In the past, all of them- Page 6 of 137

- 

### were considered stressors of concern ; however quantitative structure activity relationships ( Q SAR s ) of these chemicals , by means of the Ecological St ructure Activity Relationships (ECOSAR v. 1.00 ) module of Estimation Programs Interface SuiteTM ( EPISUITE v.4.1 , at http://www.epa.gov/opptintr/exposure/pubs/episuite.htm accessed 04/25/201 3 ), show that the first three of them: CAPA, DCPA, and HYPA, are orders of magnitude less toxic than the parent compound to all aquatic taxa (refer to Section 3.2.1.4 )

. A ll the other degradation products are considered stressors and the total residue (TR) approach was used to model the total toxic residues (TTR). This modeling strategy requires an assumption that all residues of concern have similar physical, chemical, and partitioning characteristics. Application rates for the parent pesticide are used to represent the total mass loading of pesticide and its degradation product. This modeling approach does not consider temporal occ urrence of degradation products (see

Section 3.2.1.4 )

.

Table 2.1. Che mical Profile of Fluazinam

.

Property Value Reference

and Comments

Chemical Structure Product Chemistry

Pesticide type Fungicide

Product Chemistry Chemical class Pyridine (dinitroaniline)

Molecular Formula C 13 H 4 Cl 2 F 6 N 4 O 4 Molecular Weight 465.1 g/mol

CAS No. 79622

- 59

- 6

CAS name 3

- chloro

- N

- [3

- chloro

- 2,6

- dinitro

- 4

- (trifluoromethyl) phenyl]

- 5

- (trifluoromethyl)

- 2

- pyridinamine

IUPAC name 3

- chloro

- N

- (3

- chloro

- 5

- trifluoromethyl

- 2

- pyridyl)

- α,α,α

trifluoro

- 2,6

- dinitro

- p

- toluidine

Water Solubility 0.025 mg/L at pH 5.5 and 25 o C MRID 42208403 0.071 mg/L at pH 7.0 and 25 o C

Vapor pressure 8.25 x 10 - 6 torr at 25 o C [Volatility lies between ‘ Non

- volatile under field

conditions’ to ‘ Intermediate to high volatility under field

conditions’ ( from dry non

- adsorbing surfaces ), (1) ] MRID 422 0 8403

Henry’s Law Constant 7.11 x 10 - 5 atm

- m 3 /mol ; a t pH 7 Calculated from WS and VP

Octanol/Water Partition 3620, (log K OW = 3.56) ; a t 20°C MRID 42248403

Air

- water partition coefficient (K AW ) K AW = C air /C water = Henry's Law Constant/(RT) = 2.91 x 10 - 3 (unitless) [Classified as ‘ Volatile from a water surface ’ (1) ] Calculated

R= 8.205746 x 10 - 5 atm

- m 3 /

K

- mole ; assumed T=298K )

Octanol

- air partition

coefficient (K OA ) K OA = K OW /K AW = 1.25x10 6 (unitless) Calculated

C water+soil /C air C water+soil /C air = ( C water /C air )(1/r + K d ) = (343.6) (1/6 + 29.9) = 1.03 x 10 4

[Classified as ‘ Volatile from a moist soil ’ (1), (2) ] Calculated 

## N F F

F Cl

N H

O 2 

## N O 2 

## N Cl

F F F- Page 7 of 137

- Property Value Reference

and Comments

UV/Vis Absorption At pH 7, λ

max at 239, 342 nm MRID 43521009; PMRA Regulatory Note

- REG2003

- 12 (3)

( 1 ) For classification scheme, see USEPA, 2008. See also “ Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in Problem Formulations, ” available at http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_species_reregis tration_work group/esa_reporting_fate.htm#I (accessed 0 3/26 /2013). ( 2 ) Assuming 2% organic carbon, soil to soil water ratio (w/w) = 6, and soil water to soil air (v/v) = 1 ( 3 ) Document dated 2003, page 2. The same findings are reported in the Draft Assessment Report for Fluazinam, public version, Member State Austria, Volume 3, Annex B, B.2. Physical and chemical properties, p. 15 (2005).

.



### 2.2.2

. Overview of Pesticide Usage

Fluazinam is an active ingredient in two formulated products for use on a numerous crop s and

turf ; it can be applied using a variety of application equipment . Fluazinam is registered for use on apples, brassica (cole) leafy vegetables, bushberries, carrots, ginseng, lettuce, edible podded legumes vegetables, succulent and dry b eans, onion, cucurbit vegetables, fruiting vegetables, peanuts, potatoes and soybeans

. It is applied via ground methods of application on all crops

, except for potatoes and soybeans . On potatoes and soybeans aerial applications are also allowed

. In gene ral, the spray volume is high (≥5

- 10 gal/A ground and ≥5 gal/A aerial). Application rates vary by use pattern. Multiple applications are allowed for all crops; the interval is usually 7

- 10 days , with an annual maximum rate of up to 8.41 lbs a

. i

. /A per se ason for turf . Specific use rates
are discussed in Section 3.1.

2.3 . Receptors

2.3.1

. Aquatic and Terrestrial Effects

The receptor is the biological entity that is exposed to the stressor (USEPA 199 8 ). Consistent with the process described in the Overview Document (USEPA 2004), this risk assessment uses a surrogate species approach in its evaluation of fluazinam

. T oxic ity data generated from surrogate test species, which are in tended to be representative of broad taxonomic groups, are used to extrapolate potential effects on a variety of species (receptors) included under these taxonomic groupings.

A cute and chronic toxicity data from studies submitted by pesticide registrant s along with the available open literature are used to evaluate potential direct effects of fluazinam to aquatic and terrestrial receptors. The open literature studies are located through EPA’s database ECOTOX ( http://cfpub.epa.gov/ecotox/ ), which provides a source for locating single chemical toxicity data for aquatic life, terrestrial plants, and wildlife.

Table 2.2 provides examples of taxonomic groups and the surrogate species tested to evaluat e

p otential ecological effects of pesticides to these non

- target taxonomic groups . The table also provides a summary of the acute toxicity classification s of fluazinam f or each described tax on ; note that ecotoxicity data for animals are routinely required for the TGAI only

. Additionally,- Page 8 of 137

- 

### where available, estimates of toxicity were available for the eight major degradates of fluazinam to certain taxa from the ECOSAR (v.1. 0) module of EPISUITE (v

. 4.1) . ECOSAR degradate

estimates suggest that technical fluazinam is at least one order of magnitude more sensitive than all degradates for all taxa. In some cases, certain degradates are 2 orders of magnitude less toxic than par ent fluazinam depending on the taxa.

Table 2. 2 . Taxonomic Groups and Example Test Species for Potential Effects of

Fluazinam

.

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification

TGAI (registrant submitted data) Degradates (ECOSAR estimates)

Birds 2 Mallard duck ( Anas platyrhynchos ) Bobwhite quail ( Colinus virginianus )

Zebra finch (Taeniopygia guttata) Slightly toxic No data or ECOSAR estimates

available

Mammals Laboratory rat ( Rattus norvegicus ) Practically nontoxic No data or ECOSAR estimates

available

Insects Honey bee ( Apis mellifera ) Practically nontoxic No data or ECOSAR estimates

available

Freshwater fish 3 Bluegill sunfish ( Lepomis

macrochirus ) Rainbow trout ( Oncorhynchus mykiss ) Very highly toxic Highly toxic (DAPA, AMPA, MAPA, HYPA, SDS

- 67200)

Freshwater

invertebrates Waterflea ( Daphnia magna ) Highly toxic Highly toxic (DAPA)

Estuarine/marine fish Sheepshead minnow ( Cyprinodon variegatus ) Highly toxic Slightly toxic (CAPA, DCPA)

Estuarine/marine

invertebrates Mysid ( Americamysis bahia ) Eastern oyster ( Crassostrea virginica ) Very highly toxic No data or ECOSAR estimates

available

Terrestrial plants 4 Monocots

– onion ( Allium

cepa )

Dicots

– carrot ( Daucus

carota ) Not classified

Aquatic plants and algae Duckweed ( Lemna gibba )

Freshwater blue

- green alga

( Anabaena flos

- aquae ) Not classified 5

Abbreviations: TGAI Technical grade active ingredient.

1 Major degradates identified in the laboratory include CAPA, DCPA, HYPA, DAPA, AMPA, G

- 504, MAPA &

SDS

- 67200

. 2 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

3 Freshwater fish may be surrogates for aquatic

- phase amphibians.

4 Four species of two families of monocots, of which one is corn; six species of at least four dicot families, of which one is soybeans.

5 Data from three degradates (CAPA, DCPA, and HYPA) ind icate that technical fluazinam is at east 2 orders of magnitude more toxic to algae than the three previously mentioned degradates.- Page 9 of 137

- 

### 2.3. 2. Ecosystems Potentially at Risk

The ecosystems at risk are often extensive in scope ; therefore , it may not be possible to identify specific ecosystems at the screening level. I n general terms, terrestrial ecosystems potentially at

risk could include the treated site and areas immediately adjacent to the treated site that may

receive drift

, runoff

, eroded sediment

, or discharged subsurface ( ground ) water

. Such areas could include the treatment site itself

, other cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats

, and other uncultivated areas.

Aquatic ecosystems potentially at risk i nclude water bodies adjacent to or down stream from the

treated area and may include natural or impounded lentic systems such as ponds, lakes and reservoirs, and lotic ( flowing ) water ways
, i.e.

, streams and rivers. Aquatic ecosystems supplied by groundwater , such as cave ecosystems and areas supplied by natural springs, may be at risk if a compound has the potential to leach into the subsurface

. For uses in coastal areas, aquatic

hab itat includes estuarine and marine ecosystems. Within water bod ies, the water column,

sediment , and pore water are all compartments of potential concern.

2.4

. Assessment Endpoints

Assessment endpoints represent the actual environmental value s that are to be protected, defined by ecological entities (species, community, etc. ) and their attr ibute s or characteristics (USEPA

1998 ). For fluazinam , the ecological entities assessed include the following: birds , amphibians, reptiles, mammals, freshwater and estuarine/marine fish , terrestrial and aquatic invertebrates, and

terrestrial and aquatic plants. The attributes for each of these entities may include growth, survival, and reproduction. (Se e Table 2. 3 in Section 2.6.2 , the Analysi s Plan, for further discussion).

The assessment endpoints are intended to reflect population sustainability and community structure within ecosystems and hence relate to ecosystems at risk. If risks are identified for given species/taxa based on a screening

- level assessment, then such ri sks might be expected to translate to higher levels of biological organization.

2.5 . Conceptual Model

For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological r eceptors, and a plausible route of exposure. The conceptual model is intended to provide a written description and visual representation of predicted relationships

between fluazinam

, potential routes of exposure, and the effects related to the Agency

asse ssment endpoint s

. The conceptual model consists of two major components: the risk hypotheses and a conceptual diagram (USEPA 1998).- Page 10 of 137

- 

### The conceptual model used to depict potential ecological risk s associated with the foliar uses of

fluazinam relies on prev ious assessments and the Agency’s current understanding of the environmental fate and ecological effects of the chemical

. The model assumes that fluazinam is capable of affecting terrestrial vertebrates and aquatic vertebrates and invertebrates , provided

that environmental concentrations are sufficiently elevated as a result of fluazinam’s current uses ( Figure 2.1 ). P revious risk assessments (DP Barcod es: D257063, D300893, D338293, and D342007) have identified potential acute risk to listed and non

- listed aquatic invertebrate species , chronic risk to freshwater fish, chronic risk to birds and mammals and risk to listed and

non

- listed species of aquatic plants

.

2.5. 1. Risk Hypotheses

For fluazinam , the following ecological risk hypothesis is employed for the ecological risk

assessment:

Given the registered uses of fluazinam, and its environmental fate properties, there is possible acute and chronic exposure to non

- target aquatic and terrestrial organisms. Previous risk assessments have identified risk to birds, mammals, and listed and non

listed species of aquatic fish and invertebrates

. This assessment tests the hypothesis that,

w hen used in accordance with the label, fluazinam exposure may result in adverse effects upon the survival, growth, and reproduction of non

- target aquatic and terrestrial plants

and animals.

2.5.2 . Conceptual Diagram

The potential exposure pathways and effects of the registered uses of fluazinam are depicted in Figure 2.1 . Solid arrows depict the most likely route s of exposure and effects; dashed lines depict potential routes of exposure that are not considered likely for fluazinam

. The a pplication

methods for the registered uses of fluazinam involve ground applications and aerial applications (only on potatoes and soybeans) . Ecological receptors that may be exposed to fluazinam following such applications include terrestrial and semi

- aquatic wildlife ( i.e. , mammals, birds,

terrestrial

- phase amphibians, terrestrial invertebrates, a nd reptiles) and plants. In addition, aquatic receptors ( e.g ., freshwater and estuarine/marine fish and invertebrates, aquatic

- phase amphibians, and plants) may be exposed as a result of movement of fluazinam via spray drift and

runoff f rom the site of ap plication T he conceptual framework for assessment of potential ecological risk associated with fluazinam use is depicted in Figure 2.1 ; potential endp oints, stressors, and ecological effects are identified based on this model.

Under the possible uses of fluazinam, the sources and mechanisms of release of the compound are from ground or aerial (only for potatoes and soybeans ) spray applications. Surf ace runoff from the areas of application is assumed to depend on factors such as topography, irrigation, and rainfall events. Direct deposition may result in contamination of food items that may be consumed by terrestrial organisms. Spray drift results i n contaminated adjacent areas, such as

bodies of water.- Page 11 of 137

- 

### For aquatic receptors, the major point of exposure is through direct contact with the water column, sediment, and pore water (gill/ integument) contaminated with spray drift (from spray application) a nd/ or runoff from treated areas. Indirect effects to aquatic organisms (especially fish) can also occur through impact to various food chains. The representative aquatic receptors are certain freshwater and estuarine/marine fish, invertebrates, and, in certain cases, aquatic plants. The major point of exposure for terrestrial animals is consumption of food contaminated with residues such as grass, foliage, and small insects. The representative terrestrial receptors are mammals, birds, and, in certain c ases, terrestrial plants. The attribute changes used to assess risk terrestrial receptors depend on the type of test ( e.g. , reduced survival, growth, or reproduction for animals and seedling emergence and vegetative vigor for plants). It should be noted, that these species do not cover all the possible species in the animal and plant kingdoms; certain taxa are considered as surrogates for other taxa. For example, fish are considered surrogates for aquatic phase amphibians.

The potential for bioaccumulation of fluazinam will also be examined in the risk assessment.

Because fluazinam has a fairly high K OW 

### (log K OW 

### = 3.56) and the chemical’s TTR may be persistent in water and sediments under certain circumstances , there is a p otential for

bioaccumulation. The maximum bioconcentration factor was 960

- 1220 L/kg whole fish and depuration rate is moderate (half depuration time of 5. 0

- 6.0 days , MRID # 43521012 )

. B ioaccumulation will be assessed using the results from bioaccumulation in fish studies, as well

as the K OW 

### (based) Aquatic BioAccumulation Model, version 1.0, 2009 ( KABAM ) (refer to

Section 4.1.4 ).

For terrestrial organisms, the primary route of exposure assessed at the screening level is the dietary route

, via consumption of food items such as plant leaves or insects that have fluazinam residues as a result of spraying. The assessment considers exposure of non

- target terrestrial invertebrates through oral ingestion and through contact, e.g., as a result of dir ect deposition or spray drift . Direct contact and spray drift is the major routes of exposure considered for terrestrial and wetland (riparian) plants.

Based on fluazinam’s relatively low vapor pressure 8.25 x 10 - 6 

### mm Hg and its tendency to sorb

to soils and sediments

, the chemical is not expected to volatilize readily or substantially . An analysis using the Screening Tool for Inhalation Risk ( STIR , v.1.0 ) (see Section 2.6.2 ) confirms this assumption

, so t h is assessment does not evaluate potential atmospheric transport in estimating environmental concentrations

. Simi l ar l y, the S creening I mbibition P rogram (SIP

, v.1.0 ) indicates that d rinking water exposure alone is not a potential pathway of concern

. Additionally, this ecological risk a ssessment does not account for possible ingestion of fluazinam

residues in contaminated grit or from preening activities of terrestrial animals, and it does not evaluate potential uptake through dermal absorption.

This chemical is highly insoluble and with multiple applications a significant part of the applied chemical is expected to be insoluble and a source of slow release with time. It is noted however, that this process is not included in the conceptual model but insoluble chemical may stay in the soil, move with run

- off and/or move with drift.- Page 12 of 137

- **Route of exposure includes only ingestion of fish and aquatic invertebrates Figure 2

. 1 . Conceptual Model Depicting Potential Risks to Non

- target Species From the Registered Use s of Fluazinam

. Solid arrows depict the routes of exposure and effects which are assessed for parent fluazinam and its degradates of concern based on the available data ; dashed lines depict potential routes of exposure that are not considered likely

. 

### Stressor

Source/ Transport Pathways Direct Deposition Runoff

Erosion Leaching (Infiltration/

Percolation

Source/ Exposure
Media Terrestrial Plants
Terrestrial Invertebrates Terrestrial Plants
Soil Receiving
Water Body/
Sediment Groundwater

Tested Exposure

Rou te Ingestion Direct C ontact Root Uptake Gill or Integument Uptake

Receptors

Attribute Changes Terrestrial
Vertebrates Terrestrial Plants

Individual Animals :

Reduced survival and/or reproduction Aquatic Invertebrates Aquatic Vertebrates
**Piscivorous

mammals and birds

Individual Plants :

Seedling emergence Vegetative vigor Individual Animals:

Reduced survival and/or reproduction Plant P opulation : Reduced population growth

Aquatic Plants Uptake/ Adsorption Spray Drift Volatilization Atmospheric Transport Fluazinam, and degradates of concern DAPA, AMPA, MAPA, G

- 504 and SDS

- 67200

Direct Contact

Terrestrial
Invertebrates- Page 13 of 137

- 

### 2.6 . Analysis Plan

2.6.1 . Measures of Exposure

2.6.1.1. Measures of Aquatic Exposure

M easures of exposure to aquatic animals and plants are concentrations in surface water and pore

water simulated by the Pesticide Root Zone Model (PRZM v3.12 .2 , May 12, 2005 ) and Exposure Analysis Modeling System ( EXAMS v2.98.04.06, Apr. 2005)

, coupled with the input shell s pe5 ( August 2007 ) an d EXAMS

– PRZM Exposure Simulation Shell (EXPRESS, v.1.03.02, July 2007)

, to generate estimated environ mental conc entrations (EECs) of fluazinam that may occur from use on adjace nt crops at maximum use rates. The EECs used in assessment of acute risk

are 1

- in

- 10 year return frequency daily maximum values (referred to as “peak” values). For

chronic risk as sessment, mean concentration s o ver a specified duration are generated . In both cases, each modeled site is selected to represent a site expected to be more vulnerable to runoff

than most locations where use may occur ( e.g. , based on the crop being grown)

. 1



### 2.6.1.2. Measures of Terrestrial Exposure

Terrestrial wildlife are exposed to fluazinam via consumption of residues on food items generated by spray applications

. For spray applications, the T

- REX model ( T errestrial R esidue

EX posure model ; v. 1. 5 ; March 22

, 20 12 2 

### ) is used to predict dietary exposure to fluazinam residues on foliar surfaces and insects using the Kenaga nomogram as modified by Fletcher (Hoerger and Kenaga 1972

, Fletcher et al. 1994). A default 35

- day foliar dissipation half

- life is used for terrestrial exposure modeling in this assessment , as suitable foliar dissipation data specific to fluazinam are not available ( e.g. Wi llis and McDowell 1987). Estimated exposures of

terrestrial ins ects to fluazinam are evaluated in terms of the insects’ potential relevance as dietary

items for terrestrial vertebrates and for use in risk characterization for listed terrestrial

invertebrates

.

The TerrPlant ( v

. 1.2.2 ; December 26, 2006) model is use d to derive EECs relevant to terrestrial and wetland plants for the proposed new use s of fluazinam

. The model employs the assumption that default fractions of the intended application are transported to an adjacent field through runoff and spray drift. Measures of exposure to terrestrial plants are expressed as a fraction of

the mass of the fluazinam applied to the treated field

.

The S creening T ool for I nhalation R isk (STIR v.1.0, November 19, 2010) was used to calculate an upper bound estimate of expos ure using fluazinam’s vapor pressure and molecular weight for vapor phase exposure as well as the maximum application rate and method of application for spray drift. STIR incorporates results from several toxicity studies including acute oral and

1 Information about the models can be found at http://www.epa.gov/pesticides/science/models_db.htm (accessed 03/27/2013).

2 Information about the models can be found at http://www.epa.gov/pesticides/science/models_db.htm (accessed 03/27/2013).- Page 14 of 137

- 

### inhalati on rat toxicity endpoints obtained from the “six

- pack” of core studies, which are a series of six guideline studies (including acute oral, acute inhalation, acute dermal contact, and others) that are submitted to the Registration Division of the Office of Pesticide Programs for technical and formulated products of a pesticide ( rat oral LD 50 

### = 4100 mg/kg bw , MRID 42248603 ; and

rat inh a lation LC 50 

### 0.463 mg/L, MRID 42270601 , respectively) as well as the most sensitive acute oral avian toxicity endpoint (bobwhi te quail LD 50 

### 1782 mg/kg bw, MRID 42248623 ).

Based on the results of the STIR model ( Appendix F ) , exposure through inhalation of spray drift or the vapor phase of fluazinam was not determined to be a potential pathway of concern for either avian or mammalian species on an acute exposure basis.

The analysis of the inhalation route in STIR does not include aggregation with other exposure pathways such as dietary, dermal, or drinking water may contribute to a total exposure that has a potential for effects to non

- target animals. However, the Agency does consider the relative importance of other routes of exposure in situations where data indicate that pesticide exposures

thr ough other routes may be potentially significant contributors to wildlife risk (USEPA 2004). The risk characterization section ( Section 4.3 ), includes a discussion of the impact of consideration of other routes of exposure that have been identified as pote ntially important and the degree of certainty associated with screening

- level risk assessment conclusions. Detailed information about STIR v.1.0, as well as the tool, can be found on EPA’s website ( http://www.epa.gov/pesticides/science/models_pg.htm#terrestrial ).

The S creening I mbibition P rogram (SIP v.1.0, r eleased June 15, 2010) was used to calculate an upper bound estimate of exposure using fluazinam’s solubility ( 0.071 mg/L, MRID 42208403 ), and compared to the most sensitive acute and chronic avian and mammalian toxicity endpoints (see Table 3.22 and 3.23 , respectively). Drinking water exposure alone was determined not to be a potential pathway of concern for mammalian species on both an acute and a chronic exposure basis and for avian species on a chronic exposure basis. For a sample of the output generated by SIP v.1.0, please see Appendix G

. Detailed information abo ut SIP v.1.0, as well as the tool, can be found on EPA’s website at: http://www.epa.gov/oppefed1/models/terrestrial/sip/ sip_user_guide.html

.

B ioaccumulation will be a ssessed using the results from bioaccumulation in fish studies, as well as the KABAM model (K OW 

### (based) Aquatic BioAccumulation Model, version 1.0, 2009), adjusting for biotransformation rates. KABAM is used to estimate potential bioaccumulation of hydrop hobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides.- Page 15 of 137

- 

### 2 .6.2 . Measures of Effect

Measures of effect are obtained from a suite of registrant

- submitted guideline studies which were conducted with a limited number of surrogate test species ( Table 2.2. ) . The test species are not intended to be representative of the most sensitive species but rather were selected based on their ability to thrive under laboratory conditions. Toxicity testing reported in this risk assessment

utilizes surrogate species to represent all freshwater fish (2000+) and bird (680+) species in the

U.S. T he ECOTOXicology database (ECOTOX), was searched in Ma rch 2013 to identify whether additional, mo re sensitive ecological effects data were available for fluazinam ; however,

no more useful data were identified ( USEPA 20 1 2 ).

The acute measures of effect used in this screening

- level assessment are the LD 50 

### (Lethal Dose),

LC 50 

### (Lethal Concentration)

, EC 50 

### (Effects Concentration) , and IC 50 

### (Inhibition Concentration)

. These are measures of acute toxicity which result in 50% of the respective effect in tested organisms. The endpoints for chronic measures of exposure are the NOAEC (No Observed

Adverse Effe cts Concentration) and the NOAEL (No Observed Adverse Effects Level). Toxicity studies were submitted for freshwater fish and invertebrates, estuarine/marine fish and invertebrates, aquatic plants, sediment

- dwelling organisms, birds, mammals

, and bees

. T he endpoints used for risk characterization were derived from studies which underwent review and were classified as “acceptable” (conducted under guideline conditions and considered to be scientifically valid) or “supplemental” (conditions deviated from gu idelines but the results we re considered to be scientifically valid).

2.6.3 . Integration of Exposure and Effects

The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non

- target species. For the risk assessment of fluazinam , the risk quotient (RQ) method is used to compare estimated exposure and measure d toxicity values. The RQ method involves dividing EEC s by point estimates of the most sensitive acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s L evels of C oncern (LOC ) (USEPA 2004) ( Table 2.3 ). These criteria are used to indicate when applications of fluazinam

, as directed on the label, have the potential to cause adverse e ffects to non

- target organisms.

Table 2.3. Agency Risk Quotient (RQ) Metrics and Levels of Concern (LOC) Per Risk

Class.

Risk Class Risk Description RQ LOC

Aquatic Animals (fish and invertebrates)

Acute Potential for effects to non

- listed animals from acute

exposures Peak EEC/LC 50 1 0.5

Acute

Restricted Use Potential for effects to animals from acute exposures Risks may be mitigated through restricted use classification Peak EEC/LC 50 1 0.1

Acute Listed Species Listed species may be potentially affected by acute

exposures Peak EEC/LC 50 1 0.05

Chronic Potential for effects to non

- listed and listed animals from chronic exposures 60

- day EEC/NOAEC (fish) 1- Page 16 of 137

- Risk Class Risk Description RQ LOC

21

- day EEC/NOAEC (invertebrates)

Aquatic Plants

Non

- Listed Potential for effects to non

- listed plants from exposures Peak EEC/LC 50 1 1

Listed Potential for effects to listed plants from exposures Peak EEC/NOAEC 1

Terrestrial Animals (mammals and birds) 2

Acute Potential for effects to non

- listed animals from acute

exposures EEC/LC 50 (Dietary) 0.5 EEC/LD 50 (Dose)

Acute

Restricted Use Potential for effects to animals from acute exposures Risks may be mitigated through restricted use classification EEC/LC 50 (Dietary) 0.2 EEC/LD 50 (Dose)

Acute Listed Species Listed species may be potentially affected by acute

exposures EEC/LC 50 (Dietary) 0.1 EEC/LD 50 (Dose)

Chronic Potential for effects to non

- listed and listed animals from chronic exposures EEC/NOAEC 1

Terrestrial and Semi

- Aquatic Plants

Non

- Listed Potential for effects to non

- target, non

- listed plants from

exposures EEC/ EC 25 1

Listed Plant Potential for effects to non

- target, listed plants from

exposures EEC/ NOAEC 1 EEC/ EC 05

1 LC 50 or EC 50

. 2 EEC b ased on upper bound Kenag a nomogram values for foliar exposure.



### The Agency uses the probit dose

- response relationship as a tool for providing additional information on the potential for acute direct effects to individual listed species and aquatic animals that may indirectly affect the listed species of concern (USEPA 2004). As part of this evaluation, the a cute RQ for listed species is presented in terms of the chance of an individual event ( i.e. , mortality or immobilization) should exposure at the EEC actually occur for a species with sensitivity to fluazinam on par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the dose

- response relationship available from the toxicity study used to establish the acute toxicity measures of effect for each taxonomic group that is relevant to this assessment. The individual effects probability associated with the acute RQ is based on the mean estimate of the slope and an assumption of a probit dose

response relationship. In addition to a single effects probability estimate based on the mean,

uppe r and lower estimates of the effects probability are also provided to account for variance in the slope, if available. If no dose response information is available to estimate a slope for this analysis, a default slope assumption of 4.5 (with lower and up per bounds of 2 to 9) is used (Urban and Cook 1986).

Individual effect probabilities are calculated based on an Microsoft  

### Excel spreadsheet tool IEC

v 1.1 (Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP,

Environmental Fate and Effects Division (June 22, 2004). The model allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds of that estimate) as the slope parameter in the spreadsheet. The desired threshold for the probability of- Page 17 of 137

- 

### an indi vidual effect is entered as the listed species LOC or based on the calculated acute RQ, if

available.



## 3. Analysis

3.1 Use Characterization

Maximum use pattern in for mation is presented in Table 3. 1

. The product s containing fluazinam

are Omega ® 

### 500F Agricultural Fungicide (EPA Reg. No. 71512

- 1) and Fluazinam Turf (EPA Reg. No. 71512

- 20). They are flow a ble products contain ing 40.0% fluazinam. The first product is approved for uses such as potatoes, peanuts, bushberr ies , brassica (cole) leafy vegetables, ginseng

, etc. The application methods vary with the crops. For example, aerial applications are allowed only on potatoes and soybeans. Fluazinam may be applied through sprinkler irrigation (through center pivot, motorized lateral move, trave ling gun, solid set or portable 3 

### irrigation systems); however, it can also be soil inco rporated before transplant, for brassica (cole) leafy vegetables. The label requires a buffer zone of 25 ft within permanent bodies of water (lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, and estuaries) so as to allow growth of a vegetative filter strip. The product should not be applied by aerial equipm ent within

150 ft of permanent estuarine/ marine water bodies

. F or freshwater bodies of wate r, only the 25

- ft buffer zone applies. The second label, Fluazinam Turf is for use on turf grasses solely on golf

courses.

Table 3. 1

. Use information for fluazinam (based on the following labels: Omega 500F, EPA Reg. No. 71512

- 1 , and Fluazinam Turf Fungicide, EPA Reg. No. 71512

- 20)

USE SINGLE APP. RATE (lb.

a.i./A) NUMBER

OF APPS.

AT MAX

RATE MAXIMUM

SEASONAL

APP. RATE

(lb. a.i./A) INTERVAL

BETWEEN APPS. (days) APP. METHOD PHI (days)



### Apples 0.33

- 0.45 10 4.50 7

- 10 Broadcast

spray A 

### 28

Brassica (Cole) Leafy Vegetables Crop Group 5, plus Turnip Greens

, such
as, but not limited to: broccoli; broccoli raab (rapini); Chinese cabbage (napa); cauliflower; collards, kale; mizuna; mustard spinach; Chinese broccoli;

Brussels sprouts; Chinese cabbage (bok choy); Chinese mustard cabbage; cavalo broccoli; kohlrabi; mustard

greens; rape greens
, plus turnip greens from Crop Group 2 

### [Transplant

2.01 lb ]

[S oil

incorporation 

### 1.36 lb] B 

### 1 2.0 1 N/A Soil drench

after transplant

or soil incorporated

( 6

- 8 inch

depth

, transplant the seedlings into the

treated band) 

### 20 for leafy greens

such as

mustard

greens ; 

### 50 for heading vegetables

such as cabbage

and

broccoli

3 Wheel move, side roll, end tow, or hand move portable irrigation systems.- Page 18 of 137

- USE SINGLE APP. RATE (lb.

a.i./A) NUMBER

OF APPS.

AT MAX

RATE MAXIMUM

SEASONAL

APP. RATE

(lb. a.i./A) INTERVAL

BETWEEN APPS. (days) APP. METHOD PHI (days)



### Bushberry Crop Subgroup

13

- 07B, such as, but not

limited to: Aronia berry, blueberry (highbush and lowbush), Chilean guava, currant (Buffalo, black, red, and Native), elderberry, European barberry, gooseberry, highbush cranberry, honeysuckle, huckleberry, jostaberry, juneberry, lingonberry, salal,

and sea buckthorn 

### 0.65 2 6 (at the

max rate) 3.9 1 7

- 10 Ground C 

### 30

Carrots 0.52 1 4 2.0 9 1 st 

### app at 14 days; subsequent


### apps at 7 days Ground D 

### 7

Ginseng 0.52 1

- 0.78 2 4 3.13 7

- 14 Ground D 

### 30

Lettuce (head and leaf) 

### 0.521

- 0.782 1 0.782 N/A Ground D 

### : foliar band,

broadcast

spray or soil drench 30

Edible

- Podded Legume Vegetables Crop Subgroup 6A,
except peas

, such as, but

not limited to: Phaseolus spp. Such as: runner bean, snap bean, wax bean; Vigna spp. Such as: asparagus bean, Chinese longbean, moth bean, yardlong bean; jackbean, and sword bean



### 0.26 1

- 0.44 3 2 0.91 2 7

- 10 Ground, Sprinkler irrigation 14

Succulent Bean Crop Subgroup 6B

(such as, but not limited to lima bean and broad bean) 

### 14

Dry Bean Crop Subgroup 6C, except Peas and Soybeans (such as, but not

limited to dried cultivars of bean: Lupinus spp.; Phaseolus spp, such as kidney beans, dry lima bean, navy bean, pinto bean; Vigna spp., such as adzuki bean; and broad bean, such as

labl ab bean) 

### 30- Page 19 of 137

- USE SINGLE APP. RATE (lb.

a.i./A) NUMBER

OF APPS.

AT MAX

RATE MAXIMUM

SEASONAL

APP. RATE

(lb. a.i./A) INTERVAL

BETWEEN APPS. (days) APP. METHOD PHI (days)



### Bulb Vegetables Crop Subgroup 3

- 07A (includes bulb daylily, bulb fritillaria, bulb garlic, bulb great headed garlic, bulb serpent garlic, bulb lily, bulb onion, bulb Chinese onion, pearl onion, bulb potato onion, bulb shallot,

and cultivars, varieties, and/or hybrids of these) 

### 0.52 1 6 3.13 7

- 10 Ground (minimum 5 gal/A)

, or

through sprinkler irrigation 7



### 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 2 6 4.69 7

- 10 Foliar E 

### 30

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 

### 0.521

- 0.78 2 6 4.69 7

- 14 Foliar E, F 

### 30

Peanut 0.521

- 0.78 2 2 at

max rate or 3

at 0.70

lb a.i./A 2.09 21

- 28 Ground, Sprinkler irrigation G Do not apply w/in

30 d of threshing

for harvest



### Potato 0.1 79

- 0.26 1 7 1.82 7

- 10 Ground or Aerial, Sprinkler irrigation 14

Soybeans 0.391

- 0.52 1 2 1.04 10

- 14 Ground or

Aerial H 

### NS

Turf grasses only on golf courses (tees, greens, fairways and roughs) 

### 0.7 00 12 8.41 14 Ground I 

### N/A

N/A=not applicable; Buffer zone restrictions are described below.

A. Applications based on a tree size requir ing a dilute spray of 200 gal/A- Page 20 of 137

- B. For transplants, assume maximum rate; the recommended application rate is 6.45 oz/100 gal, but the spray volume is not specified. When soil incorporated, apply in a minimum spray volume of 50 gal/A.

C. Do not use an adjuvant in the spray mixture. Applications should correspond roughly with apps at green tip, pink tip, early bloom, full bloom, blossom drop, and small green fruit to some blue fruit.

D. Carrots: Apply in 30

- 50 gal wa ter/A as a directed band spray over the crop. Ginseng: Apply in a minimum of 100 gal water/A. Lettuce: Apply in a minimum of 50 gal water/A

E. Use sufficient water to provide coverage of foliage. M ay be applied through sprinkler system irrigation equipm ent.

F. T he initial application may be made as a soil drench at transplanting

. G. Apply at 45

- 70 days after planting.

H. Ground or aerial. The first application should be applied at R1 (early bloom) to R2 (full bloom) stage of development and if needed at stage R3 (early pod formation). Do not apply after growth stage R3.

I. Apply Fluazinam Turf in sufficient water to obtain adequate uniform coverage of the turf.



### F luazinam may be applied through sprinkler irrigation (through center pivot, motorized lateral move, traveling gun, solid set or portable 4 

### irrigation systems) ; however, it can also be soil incorporated before transplant, for Crop Group 5, b rassica ( c ole) l eafy v egetables, in soils with

low infiltration rates

. The product s contain 4.17 lb A.I. per gallon and are formulated as flowable fungicide s . The percentage A.I. is 40.0 and 60.0% other ingredients (both labels).

Additional information derived from the labels is as follows:

Environmental Hazards stateme nts (t he following environmental hazard statements already exist on the labels):

i. End

- Use Product Environmental Hazards

Omega 500F and Fluazinam Turf :

“ This product is toxic to fish and aquatic invertebrates. Do not apply directly to water, or to

area s where surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate water when cleaning equipment or disposing wash waters or rinsate. Do not apply when weather conditions favor drift from treated areas. Runoff an d drift from treated areas may be hazardous to aquatic organisms in neighboring areas. ”

ii. Surface and Ground Water Advisory

Omega 500F :

“ Do not cultivate within 25 feet of permanent water bodies (lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, and estuaries) so as to allow growth of a vegetative filter strip. ”

According to USDA (2000), “conservation buffers are areas or strips of land maintained in permanent vegetation. These buffers can be used in a systems approach to manage soil, water, nutrients, and pesticides for sustainable agricultural production, while minimizing environmental impact...To be effective in trapping this type of pesticide, buffers must slow runoff and increase infiltration so that pesticides can be trapped a nd degraded in buffer soil and vegetation.”

4 Wheel move, side roll, end tow, or hand move portable irrigation systems.- Page 21 of 137

- 

### “ Do not apply OMEGA 500F within 25 feet of permanent water bodies (lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, and estuaries). Do not apply OMEGA 500F by aerial equipment within 150 feet of marine/estuarine areas. ”

Fluazinam Turf :

“ Do not apply Fluazinam Turf within 25 feet of permanent water bodies (lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, and estuaries). ”

iii. Label Statement for Spray Drift Manageme nt

Omega 500F and Fluazinam Turf :

“ AVOIDING SPRAY DRIFT AT THE APPLICATION SITE IS THE RESPONSIBILITY OF THE APPLICATOR. The interaction of many equipment and weather related factors determine the potential for spray drift. The applicator is responsible for considering all these factors when making decisions. Where states have more stringent regulations, they must be observed. ”

Fluazinam Turf :

“ Do Not apply Fluazinam Turf when the wind direction is toward aquatic areas to minimize drift

to these areas. ”

Other Details:

The label does not specify a droplet size or the maximum wind speed allowed during an application ; however

, the spray volume is specified.

Spray volume for Omega 500F Spray volume will usually range from 20

- 100 gal/ A for dilute sprays and 5

- 10 gal/A for concentrate ground and aerial sprays. The minimum volume for aerial sprays is 5 gal/A.

Spray volume for Fluazinam Turf Apply in a minimum spray volume of 40 gal water/A on fairways and 90 gal water/A on tees and

greens.

Specific Gravity Omega 500F and Fluazinam Turf (Secure) specific gravity, from their MSDS, is 1.23

- 1.26 g/mL.

Tank Mixtures They are allowed for Fluazinam Turf ( e.g. , liquid fertilizers, growth regulators, insecticides and biological control prod ucts) and for Omega 500F.

Rotational crops plant setback restrictions If it is a crop allowed in the label, it can be planted immediately. Other crops can be planted 30 days after the last application.

Sprinkler irrigation- Page 22 of 137

- 

### Apply this product only throug h:

A. center pivot, motorized lateral move, traveling gun, or

B. solid set or portable (wheel move, side roll, end tow, or hand move) irrigation system(s) DO NOT apply this product through any other type of irrigation system.

According to the Screening Level Us age Analysis (SLUA) provided by the Biological and Economic Analysis Division (BEAD) in October 201 1 ( Table 3.2 )

.

Table 3. 2 . Estimates of Agricultural Us age of Fluazinam (OPP/BEAD)

. Percent Crop Ttd.

Crop Lbs. A.I. Avg.

Beans (Snap, Bush, Pole, String) <500 <2.5

Dry Beans/Peas 8,500 <2.5

Lima Beans <500 <2.5

Peanuts 10,000 <2.5

Potatoes 60,000 10

All numbers rounded. Data sources: Screening Level Usage Analysis (SLUA), OPP/BEAD, October 20, 2011. These results reflect amalgamated data developed by the Agency and are releasable to the public. SLUA data sources include:

USDA

- NASS (United States Department of Agriculture's National Agricultural Statistics Service)

Private Pesticide Market Researc h California DPR (Department of Pesticide Regulation)



### 3.2

. Exposure Characterization

3.2. 1. Environmental Fate and Transport Characterization

E nvironmental fate characteristics of the parent compound fluazinam are listed in Table s 3. 3 a and 3.3b and are discussed in greater detail in the following sections. The status of the environmental fate data requirements is presented in Appendix F

.

Table 3. 3 a

. Summary of Environmental Fate Properties of Fluazinam Related to

De gradation and Metabolism

Study System Name/

Characteristics Value (Kinetic Model 1
if Applicable) Half

- life Value

Used to Derive

Model Input

Parameters 2 Reference, Study Classification *

and Comments DT 50 (days) DT 90 (days)

Abiotic Hydrolysis pH 5, 22 0 C Stable Stable MRID 42208412 (A)

CAPA is ex cluded from

the TTR. pH 7, 22 0 C 50.7 (SFO) 168 (SFO) SFO DT 50 = 50.7 days
pH 9, 22 0 C 5.6 (SFO) Atmospheric Degradation 3 Hydroxyl radical 3 163 (estimated) Estimated using EPI

Suite v.4.1

Direct Aqueous Photolysis pH 5, 25 0 C 2.17 (SFO) 7.2 (SFO) MRID 44807312, 43521009, 45584204 (A)

Dark control stable. TTR pH 5, 25 0 C 4.55 4 (SFO) 15.1 4 (SFO) SFO DT 50 = 4.55 days 4- Page 23 of 137

- Study System Name/

Characteristics Value (Kinetic Model 1
if Applicable) Half

- life Value

Used to Derive

Model Input

Parameters 2 Reference, Study Classification *

and Comments DT 50 (days) DT 90 (days)

Soil Photolysis Loamy sand from Ohio, pH 7.0, 2.2%
OM, 25 0 C Light exp. Dark control Photolytic t 1/2 : MRID 44807313,

45584204 (A) ;
R esults for two

radiolabels (SFO in all instances) 23.1 68.6 35.0 days

21.2 69.3 29.7 days

Aerobic Soil

Metabolism ’18 Acre” sandy loam, pH 6.9, 4.4%
OM, 20 0 C 45.9 4 (DFOP) 481 4 (DFOP) Slow t 1/2 (DFOP) = 189 days 4 MRID 42208413,

42208414 (A) ;

HYPA is excluded from

the TTRs.

Parent only: ‘18 Acre’

152 days (DFOP s low

t 1/ 2 ); Frensham 221 days (SFO) Frensham loamy sand, pH 6.4, 1.7%
OM, 20 0 C 221 4 (SFO) 734 4 (SFO) SFO DT 50 = 221 days 4

Input value for modeling in PRZM/

EXAMS from the

two above mentioned systems Represents the 90 th percentile of the upper confidence

bound on the mean of two

half

- life values (189, 221 days): mean 205 days; std. dev. 22.62742 days; n=2, t 90,n

1 = 3.078). n s t t t 1

- n 90,

1/2 input + =

= 254 days 4

Anaerobic Soil

Metabolism ’18 Acre” sandy loam, pH 6.9, 4.4%
OM, 20 0 C 4 days for parent only (flooded at 0 days) MRID 42208413,

42208414 (S) 32 days for parent only (flooded at

30 days)

Aerobic Aquatic Grand River/ loamy sand sediment; pH 7.4, 0.59% OM;

25 0 C 5.29 4

(DFOP) 81.0 4

(DFOP) Slow t 1/2 (DFOP) = 32.6 4 days at
25 0 C MRID 44807314 (A) ; 48361525 (S)

Virginia Water and Emperor Lake systems from the UK;

For the parent only:

Grand River 4.0

- 7.4 hours; Virginia Water 2.8 days (SFO); Emperor Lake t IORE = 8.33 days Stream water/ loamy

sand sediment (Virginia Water): pH 6.1

- 6.6, 5.8%
OM; 20 0 C 5.91 4

(IORE) 54.9 4

(IORE) t IORE = 16.5 4 days

at 2 0 0 C
[ t IORE corrected for temperature at

25 0 C is 11.7 days ]

Water/sandy loam (Emperor Lake); pH

5.1

- 5.8; 7.5% OM;

20 0 C 6.63 4

(IORE) 70.7 4

(IORE) t IORE = 21.3 4 days

at 2 0 0 C
[ t IORE corrected for temperature at

25 0 C is 15.1 days]- Page 24 of 137

- Study System Name/

Characteristics Value (Kinetic Model 1
if Applicable) Half

- life Value

Used to Derive

Model Input

Parameters 2 Reference, Study Classification *

and Comments DT 50 (days) DT 90 (days)

Input value for modeling with PRZM/EXAMS, at
25 0 C . from the three

above mentioned

systems Represents the 90 th percentile of the upper confidence

bound on the mean of three

half

- life values corrected at

25 0 C (32.6, 11.7, and 15.1 days): mean 19.8 days; std. dev. 11.21472 days; n=3, t 90,n

1 = 1.886 n s t t t 1

- n 90,

1/2 input + =

= 32.01 days (at

25 0 C) *

Anaerobic Aquatic Lake Mendota sediment (WI); sand, pH 7.6, 0.39% OM,

25 0 C ~0.33 days

– parent only MRID 43521010 (A)

Stable 4 Stable 4 Stable 4

* (A) = Acceptable; (S) = Supplemental

B olded values represent input values in the aquatic model ing in PRZM/EXAMS.

1 DT 50 and DT 90 values were calculated using nonlinear regression and single first

- order (SFO), double first

- order in parallel (DFOP), or indeterminate

- order equation (IORE). For DFOP, the overall DT 50 and DT 90 are reported when available. Otherwise, a first and second DT 50 are reported. The equations can be found in the document, Standard Operating Procedure for Using the NAFTA Guidance to Calculate Representative Half

- life Values an d Characterize Pesticide Degradation, U.S. Environmental Protection Agency dated November 30, 2012 and approved December 17, 2012.

2 The value used to estimate a model input value is the calculated SFO DT 50 , t IORE , or the 2 nd DT 50 from the DFOP equation. The model chosen is consistent with that recommended using the, Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media , Health Canada, U.S. Environmental Protection Agency, December 21, 2012. The same model used to estimate the value used to derive a model input, is used to

describe the DT 50 and DT 90 results.

3. Estimated value. Given that the persistence in air is high, the reaction is expected to be negligible, compared to other processes of dissipat ion. In order to make this estimate, there are certain assumptions made by the module of EPISUITE, which represent a typical hydroxyl reaction in the atmosphere (refer to AOPWIN module at http://www.epa.gov/opptintr/exposure/pubs/episuite.htm accessed 04/24/13 ). There is no ozone reaction

calculation available in EPI Suite v.4.1 for this chemical

. 4. V alues marked with a ( 4 ) refer to the total toxic residues (TTR). The TTRs include the parent and the following metabolites: DAPA, AMPA, MAPA, G

- 504 and DSD

- 67200. Additionally, the following metabolites are excluded: HYPA, CAPA and DCPA.



### Table 3. 4 b

. Summary of Environmental Fate Properties of Fluazinam Related to Mobility

, Field Dissipation and Fish BCF

Study System Name/

Characteristics Value (units if a pplicable) Reference, Study Classification *

and Comments

Mobility for

Fluazinam Soil \ Property K d (mL/g) K OC (mL/g OC ) MRID 42248628,

42974913 (A) ;

K OC model describes the mobility better than

the K d model. For K OC the coefficient of

variation is smaller than

for K d

. Speyer 2.1, sand 11.1 2316 Speyer 2.2 loamy

sand 43.5 1705

Itingen silt loam 27.2 1915 Diegten, clay loam 37.9 1894

Mean Value 29.9 1958 1958 mL/kg OC Slightly mobile 1

For same 4 soils K d, des =34

- 507; K OC, des =7010

- 19870; 1/n range 0.62

- 0.68 for the adsorption isotherms- Page 25 of 137

- Study System Name/

Characteristics Value (units if a pplicable) Reference, Study Classification *

and Comments Mobility of

HYPA 6 sterile soils K d =6.6

- 51 mL/g; K OC =640

- 3200 mL/g

- OC ;
K F =4.3

- 26; K FOC =450

- 1700 MRID 43528201 (A)

Mobility of

CAPA 4 domestic sterile

soils Increasing adsorption w. increasing pH

K d =4.53

- 74.9 mL/g; K OC =1280

- 4230 mL/g

- OC ;
K F =4.9

- 67 K FOC =1290

- 3780 MRID 44807315 (S)

Aged Column Leaching ’18 Acres’ sandy

loam 0.13

- 0.66% in leachate (2 radiolabels)

MRID 42208415 (A) Frensham loamy

sand 0.51

- 1.16% in leachate (2 radiolabels)

Terrestrial

Field Dissipation Ephrata, WA Kempton, ND Porterville, CA Montezuma, GA DT 50 ~9 days loamy sand, pinto beans;

DT 50 =49 days, sandy loam, beans

DT 50 =20 days, loamy sand, beans

DT 50 =17 days, sandy loam, peanuts.+

+ Degradation was biphasic and data was variable

in this site

. MRID 44807318, 44807320, 44807316; 48361521, 48361522,

48361523 (S) Montezuma, GA 28.1 days (DFOP slow t 1/2 ) for thatch

1 3.7 days (DFOP slow t 1/2 ) for soil 2

Northwood, ND 117 days (SFO) for thatch 578 (t R IORE ) for soil 2

Porterville, CA 1.95 days ((t R IORE ) for turfgrass 35.5 days (SFO) soil 2

Special Runoff Study Dinwiddie County,

VA Three sandy loam plots planted to peanut had 10 x 23 ft. untreated grass buffer located downslope :
R eduction in runoff yields ranged from 1.2 to

58.3%. MRID 44807330 (S)

Fish BCF Bluegill sunfish ( Lepomis

macrochirus ) 273

- 348 L/kg (fillet)

960

- 1220 L/kg (whole fish)

1410

- 1850 L/kg (non

- edible)

~67% of the residues eliminated from the fillet during the 21

- day depuration phase Depuration t 1/2 = 5.0

- 6.0 days was reported. MRID 43521012 (A)

* (A) = Acceptable; (S) = Supplemental

B olded values represent input values in the aquatic model ing in PRZM/EXAMS.

1

. Mobility classification per FAO 2000.

2

. Fluazinam remained mostly in the thatch/ turfgrass layer, and the upper 6” soil layer. Only very few detections below these levels were reported.



### F luazinam appears to degrade at moderate rates in aerobic soils (152 and 221 days), but it is more rapidly transformed into other compounds of similar backbone structure in high pH solutions (5.6 days at pH 9) or in aerobic aquatic media (≤0.31 days

– parent only ) or anaerobic aquatic media (~0.33 to 8.3 days

– parent only ). The transformation products of flua zinam are considerably more persistent than the parent compound alone under most conditions. Fluazinam may be photolysed relatively rapidly in water ( 2.17 days ) to form a tricyclic compound (G

- 504). The total fluazinam residues (fluazinam and its transfo rmation products) are persistent in most environments ( e.g. , relatively stable to hydrolysis and in anaerobic aquatic environment) and are likely to reach aquatic media as a totality through runoff. Since fluazinam does not alter substantially its backbon e structure in the environment, but instead, goes through slight transformations of functional groups, EFED has considered parent and transformation products- Page 26 of 137

- 

### together when making assessments. While the parent and two transformation products, HYPA and CAPA, have relatively low mobility, indicating low potential for ground water contamination, there is uncertainty about the other transformation products. Based on the properties of the chemical, applications of fluazinam are likely to reach the target (the cr op), but drift is also possible. The total residues of fluazinam may reach adjacent bodies of water via runoff events and may be persistent. In this assessment, EFED calculated DT 50 

### s of decay of parent and of the parent plus certain metabolites.

3.6.1.1. Transp ort and Mobility

Fluazinam shows a low solubility in water (71 ppb at pH 7 and 25 ppb at pH 5) and a relatively low vapor pressure ( 8.25x10 - 6 

### torr) . Since the solubility is low, the Henry’s Law Constant turns

out to be moderate (7.11x10 - 5 

### atm

- m 3 

### /mol at pH 7). Fluazinam shows a moderately high octanol/water partition coefficient ( log K OW 

### = 3 .56 ) , and tendency to partition with soils (see below). Due to the fact that it appears to show short half lives in aquatic media, and it binds to soils, EFED believ es that the parent compound would not volatilize substantially.

In batch equilibrium studies, K OC 

### values ranged from 1

, 705

- 2

, 316 mL/g OC



### . Based upon these values, fluazinam is categorized as slightly mobile in four soils (FAO 2000). While these K OC 

### s

are moderately high, part of the fluazinam total residues might be associated with runoff in water and part with sediments. Similarly, an available soil column leaching study of aged fluazinam indicated low mobility of the residues of fluazinam. Less than 1% of the applied radiocarbon

was found in the leachates and >> 80% remained a t the top of the soil columns.

3.6.1.2. Degradation

The hydrolysis of fluazinam is pH dependent. It was relatively stable at pH 5, and hydrolyzed

with DT 50 

### s of 50.7 and 5.6 days

, at pHs of 7 and 9, respectively. The major degradate was CAPA. Fluazinam photolyses in aqueous solutions, mainly to G

- 504, a tricyclic compound, and possibly one or more oth er unidentified products. The DT 50 

### obtained in the study was 2.17 days.

The so il photolysis, on the other hand, the DT 50 

### was ~ 22 days (compared to

~ 69 days for the dark control). The dark control corrected DT 50 

### is 30

- 35 days.

The metabolism of fluazinam appears to be moderate in a sandy loam soil treated at 1 kg/ha (5.56 ppm) ( 152 days, DFOP s low t 1/2 

### ). This calculated half

- life is in agreement with the fact that after 361 days, 6.8 and 9.5% of the applied fluazinam remained intact for the 14 

### C

- Pyridyl and

14 

### C

- Phenyl labels, respectively; no major metabolites were observed. The san dy loam treated at 5 kg/ha yielded a DT 50 

### of 227 days; in this case, Compound XII (HYPA) was observed at up to 11.4% at 30 days posttreatment. A loamy sand soil treated at 1 kg/ha yielded a DT 50 

### of 221 days (SFO) with no major metabolites. No major degra dation products were observed in th e samples treated at 1 kg/ha , but a major fraction (~41%) was bound material at the end of the study (day 361).- Page 27 of 137

- 

### The aerobic aquatic and the anaerobic aquatic metabolism studies resulted in very short DT 50 

### s for the parent compound (≤8 hours in one study and 2.8 days and 8.33 days in two other studies that were submitted later). In addition, in such studies, various metabolites were formed. All the major transformation products observed have structures that resemble the structure of the parent; however, only a subset was considered when calculating the TTRs (see Section 3.2.1.5 ). The sum of the amount of the parent concentration plus the concentrations of the transformation products (total fluazinam residue s) decreases much more slowly than the parent alone, under both aerobic ( DT 50 

### s 16.5

- 32.6 days) and anaerobic (relatively stable) aquatic conditions. The major transformation products observed in these studies included DAPA, SDS

- 67200, AMPA, DCPA, and CAPA

.

3.6.1.3. Field Studies

Seven terrestrial field dissipation studies were submitted by the registrant. Four of them were found to provide limited supplemental information. In particular, the data for the degradates is very questionable due to poor recoveries i n a storage stability study. In general, it appeared that parent fluazinam d issipated moderately rapidly in studies conducted in Ephrata, Washington, Kempton, North Dakota, Porterville, California, and Montezuma , Georgia. The dissipation half

lives range d from 9 to 49 days. These half

- lives are generally in agreement with the aerobic soil

metabolism half

- lives (152

- 221 days) . Additionally, three other studies were conducted on turf plots in Montezuma, G eorgia (sandy loam), Northwood, North Dakota (silty loam), and Porterville, California (sandy loam). Under field conditions, fluazinam dissipated in the thatch

with calculated non

- linear half

- li v e s of 28. 1 days ( DFOP slow t 1/2 

### ), 117 days ( SFO t 1/2 

### ) and 1.95 days (t R IORE 

### ), in GA, ND and CA , respectively. Furthermore, fluazinam dissipated in the soil (0

- 15 cm depth) with calculated non

- linear half

- li v e s of 13.7 days ( DFOP slow t 1/2 

### ) , 578 days (t R

IORE 

### ), and 35.5 days (SFO t 1/2 

### ), in GA, ND and CA , respectively. MAPA, HYPA

, and CAPA

were detected in these studies. The vast majority of the residues remained in the thatch/turf and the uppermost soil level.

3.6.1.4. Bioconcentration in Fish

Fluazinam demonstrated some potential to bioaccumulate in fish. The maximum BCF’s were 348 L/kg for fillet, 1220 L/kg for who le fish, and 1850 L/kg for viscera, all of which were

obtained with the [ 14 

### C]

- phenyl label material. Fish residues identified included the parent compound, AMPA, MAPA and DAPA. Depuration was moderate ( reported to be 5.0

- 6.0 days ).

More than 67% of the residues were eliminated from the fillet during the 21

- day depuration phase.

3.6.1.5. Transformation Products

Major degradates of fluazinam include CAPA, DCPA, HYPA, DAPA, AMPA, G

- 504, MAPA,

and SDS

- 67200 ( Table 3.4 ). There is mobility information for two of th e transformation products of fluazinam: HYPA and CAPA. Of them, HYPA appeared to be moderately to slightly mobile (K OC 

### =450

- 1700, 6 soils), and CAPA appeared to be slightly mobile, but- Page 28 of 137

- 

### generally less mobile than the parent (K OC 

### =1

, 289

- 3

, 784 in 4 soils). Ho wever, t he latter two

batch/ equilibrium studies were conducted on sterile soils (see Table 3.3 ).

In the past, EECs were calculated for total fluazinam residues ( including all the major degradates

of fluazinam ) because the environmental fate studies indicated that the parent compound undergoes rapid transformation to compounds with a similar structure to the parent under most conditions [this approach is consistent with the OPP’s Health Effects Division’s (HED) Metabolism Assessment Review Committee (MARC) request, (DP Barcode D272624, W. Cutchin, 04/23/2001)]. However, for this assessment ECOSAR v.1.0 runs were performed

, and it was decided to exclude the degradates HYPA, DCPA , and CAPA, from the expression of the

TTRs based on the estimated toxicity as compared to parent fluazinam (refer to Section 3.3.3 )

.

Table 3. 5

. Major Transformation Products of Environmental Fate Studies for F luazinam

Common Name (Lab Studies ID’d * ) Chemical Name

SMILES Code Structure

F lu azinam
(Parent compound) CAS Name: 3

- chloro

- N

- [3

- chloro

- 2,6

- dinitro

- 4

- (trifluoromethyl) phenyl]

- 5

- (trifluoromethyl)

- 2

- pyridinamine;

IUPAC Name: 3

- chloro

- N

- (3

- chloro

- 5

- trifluoromethyl

- 2

- pyridyl)

- α,α,α

- trifluoro

2,6

- dinitro

- p

- toluidine

C1=C(C(=NC=C1C(F)(F)F)N(C2=C(C=C(C

(=C2[N+]([O

- ])=O)Cl)C(F)(F)F)[N+]([O

- ])=O)[H])Cl

CAPA
(Hydrolysis, aerobic
aquatic metabolism) 3

- chloro

- 6

- (3

- chloro

- 2,6

- dinitro

- 4

- trifluoromethyl anilino)nicotinic acid;

5

- chloro

- 6

- (3

- chloro

- α
, α
, α

- trifluoro

- 2,6

- dinitro

- p

- toluidino)nicotinic acid

C1=C(C(=NC=C1C(=O)O[H])N(C2=C(C=C

(C(=C2[N+]([O

- ])=O)Cl)C(F)(F)F)[N+]([O

- ])=O)[H])Cl- Page 29 of 137

- 

### Common Name (Lab Studies ID’d * ) Chemical Name

SMILES Code Structure

DAPA , Cpd VIII

(Anaerobic soil

metabolism, aerobic
aquatic metabolism,
anaerobic aquatic

metabolism) 3

- chloro

- N 4

- (3

- chloro

- 5

- trifluoromethyl

- 2

- pyridyl)

- α,α,α

- trifluorotoluene

- 3,5,5

- triamine; 3

- chloro

- 2(2,6

- diamino

- 3

- chloro

α,α,α

- trifluoro

- p

- toluidino)

- 5

- (trifluoromethyl) pyridine

C1=C(C(=NC=C1C(F)(F)F)N(C2=C(C=C(C

(=C2[N]([H])[H])Cl)C(F)(F)F)[ N]([H])[H])[

H])Cl

AMPA
(Aerobic aquatic

metabolism, anaerobic
aquatic metabolism) 2

- (6

- amino

- 3

- chloro

- α,α,α

- trifluoro

- 2

- nitro

p

- toluidino)

- 3

- chloro

- 5

- (trifluoromethyl)
pyridine

C1=C(C(=NC=C1C(F)(F)F)N(C2=C(C=C(C

(=C2[N+]([O

- ])=O)Cl)C(F)(F)F)N([H])[H])[H])Cl

DCPA
(Aerobic aquatic

metabolism) 6

- (4

- carboxy

- 3

- chloro

- 2,6

- dinitroanilino)

- 5

- chloronicotinic acid

C1=C(C(=NC=C1C(O[H])=O)N(C2=C(C=C

(C(=C2[N+]([O

- ])=O)Cl)C(=O)O[H])[N+]([O

- ])=O)[H])Cl- Page 30 of 137

- 

### Common Name (Lab Studies ID’d * ) Chemical Name

SMILES Code Structure

MAPA

, Cpd VII

(Anaerobic soil

metabolism) 3

- chloro

- N 4

- (3

- chloro

- 5

- trifluoromethyl

- 2

- pyridyl)

- 5

- nitro

- α,α,α

- trifluoro

- toluene

- 3,4

- diamine

C1=C(C(=NC=C1C(F)(F)F)N(C2=C(C=C(C

(=C2N([H])[H])Cl)C(F)(F)F)[N+]([O

- ])=O)[H])Cl

HYPA,

Cpd XII

(Aerobic soil

metabolism) 5

- [[3

- chloro

- 5

- (trifluoromethyl

- 2

- pyridyl]amino]

- α
, α
, α

- trifluoro

- 4,6

- dinitro

- o

cresol

C1=C(C(=NC=C1C(F)(F)F)N(C2=C(C=C(C

(=C2[N+]([O

- ])=O)O[H])C(F)(F)F)[N+]([O

- ])=O)[H])Cl

G

- 504
(Aqueous photolysis) 4,9

- dichloro

- 6

- nitro

- 8

- (trifluoromethyl)pyrido

- [1,2

- α ]

- benzimidazole

- 2

- carboxylic acid

C3=C(C2=NC1=C(C(=C(C=C1[N+](=O)[O

- ])C(F)(F)F)Cl)[N]2C=C3C(O[H])=O)Cl- Page 31 of 137

- 

### Common Name (Lab Studies ID’d * ) Chemical Name

SMILES Code Structure

SDS

- 67200
(Anaerobic aquatic

metabolism) 3

- chloro

- 2

- (2,6

- diamino

- α,α,α

- trifluoro

- p

toluidino

- 5

- (trifluoromethyl) pyridine

C1=C(C(=NC=C1C(F)(F)F)N(C2=C(C=C(C

=C2N([H])[H])C(F)(F)F)N([H])[H])[H])Cl

*Refers to studies where it was a major product.



### 3 .2.2

. Measures of Aquatic Exposure

3.2.2.1 Aquatic Exposure Modeling

Screening

- level EECs of fluazinam in surface water

, pore water and sediment were generated

based on maximum labeled single and seasonal use rates ( Table 3.5) . As discussed in the problem formulation, simulations were conducted using PRZM, (v3.12.2, May 2005) and EXAMS (v2.98.4.6, April 2 005) coupled with the input shell pe5.pl (August, 2007) or EXAMS

PRZM Exposure Simulation Shell (EXPRESS, v.1.03.02, July 2007) . The PRZM model simulates transformation on and transport (via runoff and spray drift) from a field, of a pesticide following i ts application to a crop. The EXAMS model simulates the subsequent fate of the pesticide in an adjacent receiving water body. As routinely employed in ecological risk assessment, the receiving water body is assumed to be a static, 1

- hectare pond of 2

- met er depth (the “standard pond”), into which a 10

- hectare cropped field drains ( USEPA 2009 a ).

Given the high aquatic toxicity of fluazinam to freshwater invertebrates

, and its likelihood to occur in sediment, the Agency will also consider the potential exp osures resulting from benthi c (pore water and sediment ) concentrations (EECs). Pore water concentrations are commonly used to predict toxicity of non

- ionic substances in sediments and characterize exposure to organisms that spend time in or near sediments (Di Toro et al. 1991; US EPA 2002). PRZM/ EXAMS

estimates 1

- in

- 10

- year peak and 21

- day mean EECs for pore water.

The scenarios listed in Table 3.5 are those currently approved for Tier II modeling which most closely represent the labeled uses for fluazinam

. Even though there were scenarios representing each of the uses, it is acknowledged that potatoes, soybeans and beans appear to represent the major uses for the chemical ( Table 3.2 ).- Page 32 of 137

- 

### Application parameters were chosen based on the likely method of application at the maximum application rate as indicated in the proposed label instructions. Chemical property and model input values ( Table 3. 6 ) were chosen according to the current Input Parameter Guidance, (USEPA 2009 b ). Based on EFED guidance, ae rial spray of liquid formulations are assumed to have 95% efficiency and 5% spray drift, and ground spray is expected to have 99% efficiency and 1% spray drift. Based on th e registered uses for fluazinam , a variety of locations and PRZM

crop scenarios wer e run to simulate national use of the pesticide. For certain crops, the maximum seasonal application rate was divided by the minimum number of applications in order to accommodate the seasonal rate. For example for peanut, the maximum individual rate is 0.782 lb a.i./A; however, a rate of 0.70 lb a.i./ A/application is modeled in order to accommodate

the seasonal rate.

Table 3. 6

. Fluazinam Uses, Scenarios, and Application Information Used for Aquatic Exposure Inputs in Fluazinam Ecological Exposure Assessment

Uses Represente d / PRZM Crop S cenarios M ethod of App. Drift/ App

Eff iciency Single

A pp R ate

(lb a.i./A) Max

No.

of Apps

at

Max

Rate Min.

Interval

Between

Apps (days) Day of

A pp (day

month) CAM IPSCND

Apples/ NC apple OR apple PA apple Ground (assumed to be airblast) 0.03/0.99 0.45 10 7 01

- 06

15

- 06

15

- 06 2 1

Brassica (Cole) Leafy Vegetables Crop Group 5, plus Turnip Greens/ CA cole

crops FL cabbage Soil drench

after transplant 0.01/0.99 2.01 lb 1 N/A 01

- 01 2 1

Same crops as above Crop Group 5, plus Turnip

Greens/ CA cole crops FL cabbage S oil incorporated (15 cm depth) 0.01/0.99 1.36 lb 1 N/A 09

- 10 4 1

Bushberry Crop Subgroup

13

- 07B/ OR berries Ground 0.01/0.99 0.652 6 7 15

- 04 2 1

Carrots/ CA row crops

FL carrot Ground 0.01/0.99 0.521 4 1 st at 14; then

7 01

- 02

31

- 10 2 1

Ginseng/ MN sugar beet Ground 0.01/0.99 0.782 4 7 01

- 08 2 1

Lettuce/ CA lettuce Ground 0.01/0.99 0.782 1 N/A 01

- 04 2 1

*Edible

- Podded Legume Vegetables Crop Subgroup 6A, except peas; *Succulent Bean Crop Subgroup 6B; *Dry Bean Crop Subgroup 6C, except Peas and Soybeans / MI beans OR snap beans Ground 0.01/0.99 0.304 3 7 01

- 07

01

- 07 2 1

Bulb Vegetables Crop Subgroup 3

- 07A/ CA onion

GA onion Ground 0.01/0.99 0.521 6 7 15

- 04

01

- 04 2 1- Page 33 of 137

- Uses Represente d / PRZM Crop S cenarios M ethod of App. Drift/ App

Eff iciency Single

A pp R ate

(lb a.i./A) Max

No.

of Apps

at

Max

Rate Min.

Interval

Between

Apps (days) Day of

A pp (day

month) CAM IPSCND

Cucurbit Vegetables, Melon Subgroup 9A/ MI melons

MO melons

NJ melons Foliar 0.01/0.99 0.782 6 7 15

- 06

01

- 06

15

- 05 2 1

Fruiting Vegetable, Pepper/ Eggplant Subgroup 8

- 10B/

CA tomato FL peppers

PA tomato Foliar 0.01/0.99 0.782 6 7 01

- 06

01

- 09

01

- 07 2 1

Peanut/ NC peanut Ground 0.01/0.99 0.70 3 21 15

- 07 2 1

Potato/ ID potato ME potato Aerial 0.05/0.95 0.261 7 7 15

- 05

15

- 06 2 1

Soybeans/ MS soybeans Aerial 0.05/0.95 0.521 2 10 16

- 05 2 1 Turf grasses on golf courses/

FL turf

PA turf Ground 0.01/0.99 0.700 12 14 01

- 04

01

- 04 2 1

N/A= not applicable ; bolded font represents the crop scenarios selected for modeling.



### Table 3. 7

. Environmental Fate Data Used for Aquatic Exposure Inputs in Fluazinam

E cological Exposure Assessment

Fate Property Value 1 

### (unit) Source/Comment

Molecular Weight 465.1 g/mol Product Chemistry

Henry’s constant 7.11 x 10 - 5 atm

- m 3 /mole Calculated from VP and solubility; at pH 7

Vapor Pressure 8.25x10 - 6 torr MRID 42248403

Solubility in Water 0.071 mg/L MRID 42208403; at pH 7.0

Photolysis in Water 4.55 days MRID 44807312, 43521009, 45584204; maximum available value, obtained at pH 5

Aerobic Soil Metabolism Half

lives n s t t t 1

- n 90,

1/2 input + =

=

254 days MRID 42208413, 42208414; Represents the 90 th
percentile of the upper confidence bound on the

mean of two ha lf

- life values (189, 221 days: Mean 205 days; Std. Dev. 22.62742 days; n=2, t 90,n

- 1 = 3.078).

Hydrolysis Half

- lives 50.7 days MRID 42208412; CAPA is excluded from the TTR

Aerobic Aquatic Metabolism

Half

- life (water column) n s t t t 1

- n 90,

1/2 input + =

= 32.01 days MRID 44807314, 48361525 ; Represents the 90 th
percentile of the upper confidence bound on the

mean of three half

- life values (32.6, 16.5, 21.3 days;
however, at 25 0 C the corrected half

- lives are 32.6, 11.7, and 15.1 days): Mean 19.8 days; Std. Dev.

11 .21472 days; n=3, t 90,n

- 1 = 1.886 Anaerobic Aquatic Metabolism

Half

- life (benthic) Stable MRID 43521010- Page 34 of 137

- 

### Fate Property Value 1 

### (unit) Source/Comment

Organic

- carbon water partition coefficient (K OC ) 1958 L/kg

- OC MRID 42248628, 42974913; Represents the average

K OC value among four values ranging from 1705 to 2316 ml/g

- OC ; the K OC model is more suitable for the mobility of fluazinam.

Incorporation Depth 0.0 cm for all crops except for 15 cm for brassica cole crops soil incorporated Label

Foliar extraction (FEXTRC) 0.5 EFED guidance

Decay rate on foliage (PLDKRT) 0 day - 1 EFED guidance

Volatilization rate from foliage (PLVKRT) 0 EFED guidance

Uptake factor (UPTKF) 0 EFED guidance

TTR=total toxic residues; TTRs include fluazinam plus DAPA, AMPA, G

- 504, MAPA, and SDS

- 67200. Additionally, the TTR exclude CAPA, DCPA and HYPA

. 1

– Inputs determined in accordance with EFED “ Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides. Version 2.1” dated October 22, 2009 (USEPA 2009b)

.



### The EECs listed in Table 3. 7 reflect 1

- in

- 10 year surface water , porewater and sediment

concentrati ons based on maximum application rates for labeled uses of fluazinam

.- Page 35 of 137

- 

### Table 3. 7 . Surface Water Estimated Environmental Concentrations (EECs) for Labeled Uses of Fluazinam

.

Scenario (bold font)/ Crops/Uses Represented App

Method App

Rate

(lb a.i./A) Date of

First Application (dd

- mm) Number

of Apps App
Interval

(days) Water Column Pore Water Sediment

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L) Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) Peak

EEC (μg/ kg

oc ) 21

- day

average

EEC (μg/ kg

oc ) Apples/ NC apple A irblast 0.45 01

- 06 10 7 38.0 17.3 9.31 6.15 6.05 12100 11900

OR apple A irblast 0.45 15

- 06 10 7 12.8 6.03 4.04 2.92 2.80 5750 5510 PA apple A irblast 0.45 15

- 06 10 7 32.8 13.2 6.43 5.27 5.19 10370 10210

Brassica (Cole) Leafy Veg

. C G 5, plus Turnip

Greens/ CA cole crops Soil

drench

after transplant 2.0 1 01

- 01 1 N/A 11.6 6.20 3.96 2.63 2.59 5180 5100

FL cabbage Soil

drench

after transplant 2.01 09

- 10 1 N/A 4.44 1.69 0.759 0.552 0.503 1090 990

FL cabbage Soil incorpor p.

(15 cm ) 1.36 09

- 10 1 N/A 1.54 0.610 0.327 0.214 0.209 421 411

Bushberry Crop S G

13

- 07B/ OR

berries Ground 0.652 15

- 04 6 7 5.73 2.92 1.74 1.38 1.32 2720 2600

Carrots/ CA

row crops Ground 0.521 01

- 02 4 1 st at 14;

then 7 4.14 1.73 1.30 0.852 0.840 1680 1650

FL carrots Ground 0.521 31

- 10 4 14, 7 15.4 5.75 3.36 2.62 2.57 5160 5060 Ginseng/ MN sugar beet Ground 0.782 01

- 08 4 7 5.04 2.28 1.27 0.850 0.819 1670 1610

Lettuce / CA

lettuce Ground 0.782 01

- 04 1 N/A 1.65 0.667 0.314 0.227 0.223 447 439- Page 36 of 137

- Scenario (bold font)/ Crops/Uses Represented App

Method App

Rate

(lb a.i./A) Date of

First Application (dd

- mm) Number

of Apps App
Interval

(days) Water Column Pore Water Sediment

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L) Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) Peak

EEC (μg/ kg

oc ) 21

- day

average

EEC (μg/ kg

oc )

* C rop S G 6A, except

peas; * S G 6B; *S G 6C/

MI beans Ground 0.304 01

- 07 3 7 3.60 1.77 1.05 0.762 0.746 1500 1470

OR snap

beans Ground 0.304 01

- 07 3 7 1.49 0.827 0.567 0.453 0.443 892 872

Bulb Veg

. Crop S G 3

- 07A/

CA onion Ground 0.521 15

- 04 6 7 1.16 0.886 0.652 0.416 0.402 819 791

GA onion Ground 0.521 01

- 04 6 7 14.7 6.11 4.69 3.12 3.07 6140 6040 Cucurbit Veg

. Melon S G

9A/

MI melons Foliar 0.782 15

- 06 6 7 19.1 8.22 4.45 2.81 2.75 5530 5410

MO melons Foliar 0.782 01

- 06 6 7 40.2 16.7 8.79 5.44 5.34 10710 10510

NJ melons Foliar 0.782 15

- 05 6 7 41.4 17.7 7.89 4.99 4.89 9820 9620 Fruiting Veg

. , Pepper/ Eggplant S G

8

- 10B/

CA tomato Foliar 0.782 01

- 06 6 7 3.73 2.20 1.30 0.841 0.823 1660 1620

FL peppers Foliar 0.782 01

- 09 6 7 31.0 14.6 7.11 4.80 4.50 9450 8860

PA tomato Foliar 0.782 01

- 07 6 7 33.4 15.0 8.85 8.51 8.31 16750 16350

Peanut/ NC
peanut Ground 0.70 15

- 07 3 21 9.70 4.75 2.57 2.00 1.96 3940 3860

Potato/ ID
potato Aerial 0.261 15

- 05 7 7 1.64 1.13 0.910 0.570 0.567 1120 1120

ME potato Aerial 0.261 15

- 06 7 7 3.01 1.66 1.15 1.02 0.993 2010 1950 Soybeans/ MS soybeans Aerial 0.521 16

- 05 2 10 6.88 3.02 2.10 1.60 1.57 3150 3090- Page 37 of 137

- Scenario (bold font)/ Crops/Uses Represented App

Method App

Rate

(lb a.i./A) Date of

First Application (dd

- mm) Number

of Apps App
Interval

(days) Water Column Pore Water Sediment

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L) Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) Peak

EEC (μg/ kg

oc ) 21

- day

average

EEC (μg/ kg

oc ) Turf grasses on golf

courses/ FL

turf Ground 0.700 01

- 04 12 14 5.98 2.18 1.16 0.782 0.763 1540 1500

PA turf Ground 0.700 01

- 04 12 14 7.73 3.83 1.83 1.19 1.17 2340 2300 Additional Runs, for the crops that could be applied aerially. The following runs are for ground applications: ID potato Ground 0.261 15

- 05 7 7 0.694 0.534 0.465 0.332 0.330 653 649 ME potato Ground 0.261 15

- 06 7 7 2.65 1.19 0.794 0.705 0.701 1387 1379 MS soybeans Ground 0.521 16

- 05 2 10 7.09 3.07 1.97 1.55 1.48 3050 2910 Veg.=Vegetable(s); CG=Crop Group; SG=Subgroup

1 EECs were rounded to three significant figures.- Page 38 of 137

- 

### 3.2.2.2. Monitoring Data

Fluazinam is included as one of the analytes monitored in U.S. surface and groundwater under

the USGS’s National Water Quality Assessment (NAWQA) program 5



### . However, a search of the USGS NAWQA Data Warehouse turned up only two reported samples for fluazinam, both in Georgia. The results were below the reporting limits (reported as <4.4 ng/L). The California Departme nt of Pesticide Regulation’s (CDPR 6 ) data was also consulted; however, samples were

not collected for this chemical

.

3.2.3. Measures of Terrestrial Exposure

3.2.3.1. Ingestion of Surface Residues by Birds and Mammals

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals by

e mphasizing the dietary exposure route of uptake of pesticide active ingredients. These exposures are considered to be surrogates for exposures to terrestrial

- phase amphibians and reptiles. For exposure s to terrestrial organisms

, such as birds and mammals, pesticide residues on food items are estimated based on the assumption that organisms are exposed to pesticide

residues as a function of the pesticide use pattern

.

T

- REX (v. 1. 5 .1 ) is used to calculate dietary and dose

- based EECs of fluazinam residues on food

items for mammals and birds generated by spray applications for the labeled uses . Input values for deriving EECs using T

- REX are located in Table 3.10 . Upper

- bound Kenaga nomogram

values are used to derive EECs for fluazinam exposures to terrestrial mammals and birds ( Table

3.11 ) , based on a 1

- year time period. Consideration is given to different types of feeding strategies for mammals, including herbivores, insectivores and granivores. D ose

- based

exposures are estimated for three weight classes of birds (20 g , 100 g , and 1000 g) and three weight classes of mammals (15 g , 35 g , and 1000 g).

Table 3. 8 . Input Parameters for Deriving Screening

- Level Terrestrial EECs for Labeled

Uses of Fluazinam ( T

- REX v. 1.5 .1 )

.

Uses Represented Single A pp R ate (lb a.i./A) Max No. of Apps at Max

Rate Min. Interval Between Apps (days) Appl e 0.45 10 7 Brassica (Cole) Leafy Vegetables Crop Group 5, plus Turnip Greens 2.01 lb 1 1 N/A

Bushberry 0.652 6 7

Carrots 0.521 4 1 st at 14; then 7 Ginseng 0.782 4 7

Lettuce 0.782 1 N/A

*Edible

- Podded Legume Vegetables Crop Subgroup 6A, except peas; *Succulent Bean Crop Subgroup 6B; *Dry Bean Crop Subgroup 6C, except Peas and Soybeans 0.304 3 7

Bulb Vegetables 0.521 6 7

5 Available at http://infotrek.er.usgs.gov/apex/f?p=NAWQA:HOME:1371472434708426 , accessed 03/28/2013.

6 Available at http://www.cdpr.ca.gov/docs/emon/surfwtr/surfdata.htm , accessed 04/25/2013.- Page 39 of 137

- Uses Represented Single A pp R ate (lb a.i./A) Max No. of Apps at Max

Rate Min. Interval Between Apps (days) Cucurbit Vegetables, Melon 0.782 6 7 Fruiting Vegetable, Pepper/ Eggplant 0.782 6 7

Peanut 0.70 3 21

Potato 0.261 7 7 Soybean 0.521 2 10 Turf grasses on golf courses 0.700 12 14

1

. For transplants, assume maximum rate; the recommended application rate is 6.45 oz/100 gal, but the spray volume is not specified. When soil incorporated, apply in a minimum spray volume of 50 gal/A.



### Differences in exposures between ground and aerial applications cannot be assessed with the

current T

- REX model ; exposure and risk estimates from the T

- REX model are considered relevant to both application scenarios. Other u ncertainties in the terrestrial EECs are primarily associated with a lack of data on interception and subsequent dissipation from foliar surfaces.

EFED assumes a default 35

- day foliar dissipation half life, based on the work of Willis and McDowell (1987) when data are absent or are ins ufficient

. Per EFED policy, a minimum of three foliar dissipation half lives are required with which to calculate an average to use I place of the default value of 35 days. For fluazinam, two values were available with which to estimate a folair dissipat ion half life and therefore the default 35 days was used for modeling purposes. An example output from the T

- REX model is provided in Appendix B

.- Page 40 of 137

- 

### Table 3. 9

. Screening

- level Dose

- based EECs (mg/kg bw) as Food Residues for Birds , Reptiles, and Terrestrial

- Phase Amphibians from Labeled Uses of Fluazinam (T

- REX v. 1.5 .1 )

. Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items Short GrassTallGrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 

Apple 713 327 401 44.4 406 186 229 25.4 182 83 102 11.4 280 159 71.3 9.90 5.64 2.53

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 549 252 309 34.3 313 144 176 19.6 140 64 78.9 8.8 215 123 54.9 7.6 4.4 1.9

Bushberry 777 356 437 48.6 443 203 249 27.7 199 91 112 124 305 174 77.7 10.8 6.16 2.76

Carrots 468 215 263 29.3 267 122 150 16.7 120 55 67.2 7.5 183 105 46.8 6.5 3.7 1.7

Ginseng 703 322 395 44 401 184 225 25.1 179 82 101 11.2 275 157 70.3 9.76 5.57 2.49

Lettuce 214 98.0 120 13.4 122 55.9 68.6 7.62 54.6 25 30.7 3.41 83.7 47.7 21.4 2.97 1.69 0.76

*Edible

- Podded Legume Vegetables ,

except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 218 100 123 13.6 125 57.1 70.1 7.78 55.8 26 31.4 3.48 85.5 48.8 21.8 3.03 1.73 0.77

Bulb Vegetables 621 285 349 38.8 354 162 199 22.1 159 73 89.2 9.9 243 139 62.1 8.63 4.92 2.20

Cucurbit Vegetables,

Melon 932 427 525 58.3 532 244 299 33.2 238 109 134 14.9 365 208 93.2 13.0 7.4 3.31

Fruiting Vegetable, Pepper/ Eggplant 932 427 525 58.3 532 244 299 33.2 238 109 134 14.9 365 208 93.2 13.0 7.4 3.31

Peanut 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

Potato 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

Soybean 259 119 146 16.2 148 67.8 83.2 9.2 66.2 30.3 37.2 4.1 102 57.9 25.9 3.6 2.1 0.92- Page 41 of 137

- Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items Short GrassTallGrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 

Turf grasses on golf

courses 762 349 429 47.6 434 199 244 27.2 194 89 109 12.2 298 170 76.2 10.6 6.03 2.7

Values are in ppm.



### Table 3. 10 . Screening

- level Dose

- based EECs (mg/kg bw) as Food Residues for Mammals from Labeled Uses of Fluazinam (T

REX v. 1.5 .1 ).
Primary Feeding Strategy  H erbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 

Apple 597 273 336 37.3 412 189 232 25.8 95.6 44 53.8 5.97 234 162 37.8 8.29 5.73 1.33

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 460 211 259 28.7 318 146 179 19.9 73.7 34 41.5 4.6 180 125 28.9 6.4 4.4 1.0

Bushberry 651 298 366 40.7 450 206 253 28.1 104 48 58.7 6.52 255 176 40.9 9.04 6.25 1.45

Carrots 392 180 221 24.5 271 124 152 16.9 62.8 2 9 35.3 3.9 154 106 24.6 5.4 3.8 0.9

Ginseng 588 270 231 36.8 407 186 229 25.4 94.7 43 53.0 5.89 230 159 36.9 8.17 5.65 1.31

Lettuce 179 82 101 11.2 124 56.7 69.6 7.73 28.7 13 16.1 1.79 70.1 48.4 11.2 2.49 1.72 0.4- Page 42 of 137

- Primary Feeding Strategy  H erbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 

*Edible

- Podded Legume Vegetables ,

except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 183 84 103 11.4 126 57.9 71.1 7.9 29.3 13 16.5 1.83 71.6 49.5 11.5 2.54 1.76 0.41

Bulb Vegetables 520 238 293 32.5 359 165 202 22.5 83.3 38 46.9 3.21 204 141 32.6 7.22 5.00 1.16

Cucurbit Vegetables,

Melon 781 358 439 48.8 540 247 303 33.7 125 57 70.4 7.8 306 211 49 10.8 7.5 1.7

Fruiting Vegetable, Pepper/ Eggplant 781 358 439 48.8 540 247 303 33.7 125 57 70.4 7.8 306 211 49 10.8 7.5 1.7

Peanut 336 154 189 21.0 232 106 130 14.5 53.8 25 30.3 3.36 131 90.8 21.1 4.70 3.22 0.75

Potato 287 131 161 17.9 198 90.8 111 12.4 45.9 21.1 25.8 2.87 112 77.6 18 3.98 2.75 0.64

Soybean 217 96 122 13.6 150 68.7 84.4 9.4 34.8 16 19.6 2.2 85 58.7 13.6 3.01 2.1 0.48

Turf grasses on golf

courses 678 292 359 39.9 441 202 248 276 102 46.8 57.5 6.4 250 173 40 8.9 6.12 1.42

Values are in ppm.- Page 43 of 137

- 

### Table 3. 11 . Screening

- level Dietary

- based EECs (mg/kg diet) as Food Residues for Birds, Reptiles, Terrestrial

- phase Amphibians, and Mammals from Labeled Uses of F luazinam (T

- REX v. 1.5 .1 ).
Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) 

Apple 625.73 286.79 351.97 39.11 245.08

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 482.4 221.1 271.35 30.15 188.94

Bushberry 682.65 312.88 383.99 42.67 267.37

Carrots 411.15 188.44 231.27 25.70 161.03

Ginseng 617.12 282.85 347.13 38.57 241.71

Lettuce 187.68 86.02 105.57 11.73 73.508

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 191.77 87.89 107.87 11.99 75.11

Bulb Vegetables 545.49 250.02 306.84 34.09 213.65

Cucurbit Vegetables, Melon 818.76 375.26 460.55 51.17 320.68

Fruiting Vegetable, Pepper/ Eggplant 818.76 375.26 460.55 51.17 320.68

Peanut 351.96 161.32 197.98 22.00 137.85

Potato 300.533 137.744 169.050 18.783 117.709

Soybean 227.615 104.323 128.033 14.226 89.149

Turf grasses on golf courses 668.90 306.58 376.26 41.81 261.99

Values are in ppm.



### 3.2.3.2. Runoff and Spray Drift to Terrestrial and Semi

- Aquatic Plants

Exposure of non

- target terrestrial and semi

- aquatic (wetland) plant species is estimated using the TerrPlant (v

. 1.2.2 ) model. Loading via spray drift to dry, non

- target, adjacent areas is assumed

to occur from one acre of treated land to one acre of the non

- target area. Runoff is also expected

to be a source of pesticide loading to non

- target areas. TerrPlant calculates EECs as a function

of application rate, solubility

, and default assumptions regarding spray drift. The default spray drift assumptions are 1% of the application rate for ground spray applications and 5% for aerial spray applications (USEPA 2006b)

. The EECs for terrestrial and semi

- aquatic plants for a single application of fluazinam at the maximum label ed rates for representative uses are presented in

Table 3.12 (see example output in Appendix C ).- Page 44 of 137

- 

### Table 3. 12 . EECs for Terrestrial and Semi

- Aquatic Plants Near Fluazinam Use Areas (TerrPlant v. 1.2.2).

Crop Single Max. Application

Rate (lbs a

. i

. /A) EECs (lbs ai/A)

Runoff to dry areas Runoff to

semi

aquatic

areas Spray

drift Total for dry

areas Total for

semi

aquatic

areas

Apple 0.45 0.005 0.045 0.023 0.027 0.068

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 2.01 lb 0.002 0.022 0.013 0.016 0.036

Bushberry 0.652 0.007 0.065 0.007 0.013 0.072

Carrots 0.521 0.005 0.052 0.005 0.010 0.057

Ginseng 0.782 0.008 0.078 0.008 0.016 0.086

Lettuce 0.782 0.008 0.078 0.008 0.016 0.086

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 0.304 0.003 0.030 0.003 0.006 0.033

Bulb Vegetables 0.521 0.005 0.052 0.005 0.010 0.057

Cucurbit Vegetables, Melon 0.782 0.008 0.078 0.008 0.016 0.086

Fruiting Vegetable, Pepper/ Eggplant 0.782 0.008 0.078 0.008 0.016 0.086

Peanut 0.70 0.007 0.070 0.007 0.014 0.077

Potato 0.261 0.003 0.026 0.013 0.016 0.039

Soybean 0.521 0.005 0.052 0.026 0.031 0.078

Turf grasses on golf courses 0.700 0.007 0.07 0.007 0.014 0.077

NA 

### Not applicable.

3.2.3.3. Terrestrial Organism Exposure to Residues in Aquatic Food Items (KABAM)

The KABAM model (K OW 

### (based) Aquatic BioAccumulation Model) version 1.0 was used to evaluate the potential exposure and risk of direct effects to birds and mammals via bioaccumulation and biomagnification in aquatic food webs. KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides. The bioaccumulation portion of KA BAM is based upon work by Arnot and Gobas (2004) who parameterized a bioaccumulation model based on PCBs and some pesticides ( e.g ., lindane, DDT) in freshwater aquatic ecosystems (Arnot and Gobas, 2004) . KABAM relies on a

chemical's octanol

- water partitio n coefficient (K OW 

### ) to estimate uptake and elimination constants through respiration and diet of organisms in different trophic levels. Pesticide tissue residues are calculated for different levels of an aquatic food web. The model then uses pesticide ti ssue concentrations in aquatic animals to estimate dose

- and dietary

- based exposures and associated risks to mammals and birds (surrogate for amphibians and reptiles) consuming aquatic organisms. Seven different trophic levels including phytoplankton, zoo plankton, benthic- Page 45 of 137

- 

### invertebrates, filter feeders, small

- sized (juvenile) forage fish, medium

- sized forage fish, and larger piscivorous fish, are used to represent an aquatic food web

. Importantly, chemical metabolism by biota is assumed to be zero in KABAM unless evidence indicates such metabolism is likely to affect the model predictions substantially. Example output from the bioaccumulation model is provided in Appendix H

.

Table 3.13 . Bioaccumulation Model Input Values for Fluazinam

Parameter Input Value Source

Pesticide Name Fluazina m Log K OW 3.56 MRID 42248403

K OC 1958 L/kg OC MRIDs 0 2248628, 42974913 

### Highest Exposure Scenario Modeled

Use patterns Fruiting vegetab l es (PA tomato scenario) ( foli a r , app rate 0.782 x 6 )

Concentration in sediment pore water (ppb) Peak = 8 .51 ppb ; 21 day = 8.31 (for the total residues)

Total pesticide concentration in water (ppb) Peak = 33.4 ppb; 21

- day = 15.0 ppb (for the total residues)



### Based on the bioaccumulation model, estimated concentrations of fluazin a m residues in the tissue of organisms in the different trophic levels following application on ornamentals range

from 1,323 to 2,698 μg/kg ( Table 3 .14 ).

Table 3.14 . Predicted Concentrations of Fluazinam in Aquatic Organism Tissues at Different Trophic Levels

Trophic Level Estimated Total Concentration (μg/kg)

Phytoplankton 2,557 Zooplankton 1,877

Benthic Invertebrates 2,005

Filter Feeders 1,323 Small Forage Fish 2,590 Medium Forage Fish 2,608

Large Forage Fish 2,698



### 3.3

. Ecological Effects Characterization

The ecological effects characterization for fluazinam is based up on registrant

- submitted toxicity

data for the TGAI ( parent compound ) and for specified formulations

. Appendix G l ists these

studies

, their review classifications

, and associated deficiencies. The ecotoxicity data for

fluazinam and its associated produc ts have been reviewed previously in multiple ecological risk assessments ( e.g., USEPA 2006, 2002, 2000 ) and in a Preliminary Problem Formulation for Registration Review (USEPA 2008). These data are summarized briefly in Sections 3.3.1 and

3.3.2

. Various studies with terrestrial and aquatic plant s, birds, and aquatic animals exposed to

either the TGAI or formulated fluazinam have been received since the Problem Formulation was issued; the results of these studies are described briefly in this secti on

.- Page 46 of 137

- 

### T he results of a 201 2 review of the Ecological Incident Information System (EIIS) are described

in Section 3.3.3 (USEPA 20 12 )

. A search of the ECOTOXicology database in March, 2013

, yielded no new data from suitable studies with more sensitive toxicity endpoints than the registrant

- submitted guideline studies described below

.

3.3.1. Aquatic Toxicity Assessment

A summary of the most sensitive aquatic toxicity data for fluazinam , based on a current Agency review of all submitted data, is provided in Table 3.15 through Table 3. 2 1 and discussed further

in Sections 3.3.1.1 through 3.3.1.5

. The available data indicate that fluazinam TGAI is very highly toxic to freshwater fish and estuarine/marine invertebrates and highly tox ic to freshwater

invertebrates and estuarine/marin e fish.

3.3.1.1. Toxicity to Freshwater Fish

There are three acute freshwater fish toxicity studies available for fluazinam ( Table 3.15 ) . In a

flow

- through study with the rainbow trout ( Salmo gairdneri , MRID 42208409), the 96

- hour LC 50 

### was determined to be 110 μg a.i/L. It is noted that this endpoint exceeds the solubility limit of fluazinam which is 72 μg a.i/L. There were daily observations made for sublethal effects that included rapid respiration, dark pigmentation, surfacing, and loss of balance. These effects occurred on all days of the study at all treatment concentrations ( 57

- 460 μg a.i/L mean measured) . This study is classified as acceptable.

In a second flow

- through study conducted with the rainbow trout (MRID 42974904), the 96

- hour

LC 50 

### was determined to be 36 μg a.i/L. Mean measured concentrations ranged from 10

– 56 μg

a.i

. /L in the study (including negative and solvent controls) . There were no mortalities or

sublethal effects observed in the control or the two lowes t treatment concentrations (10 and 15 μg a.i/L mean measured, respectively). There was 35 and 100% mortality in the two highest treatment concentrations (33 and 56 μg a.i/L, respectively). Sublethal effects occurred in the three highest treatment concent rations only on all day of the study and included darkened pigmentation, loss of equilibrium, surfacing, and lethargy. This study is classified as acceptable.

In a study conducted under flow

- through conditions with the bluegill sunfish ( Lepomis

macroch irus , MRID 42974905), fish were exposed to mean measured concentrations ranging

from 21

– 93 μg a.i/L (including negative and solvent controls) . Mortality in the two highest treatment concentrations was 90 and 100% in the 66 and 93 μg a.i/L concentrations , respectively. Sublethal effects occurred only in the second highest treatment concentration and included loss of equilibrium and lethargy. The LC 50 

### was determined to be 52.g a.i/L. This study was classified as acceptable

. These three studies indicate that fluazinam is very highly toxic to freshwater fish on an acute exposure basis. Additionally these studes indicate that toxicity was near or exceeded the reported limit of solubility for fluazinam.- Page 4 7 of 137

- 

### Table 3. 8 . Summary o f Acute Toxicity Data for Freshwater Fish Exposed to Fluazinam

Species Study Type Test Substance (Purity) LC 50 ( μ g a.i /L) 1,2 ,3

(95% CL ;

slope ) Toxicity Classification (MRID)

Rainbow trout ( Oncorhynchus mykiss ) 96

- hour, flow

through TGAI (97.4%) 130 ( 100

– 180 ; N/A ) Highly toxic ( 42208409 )

96

- hour, flow

through TGAI ( 96.8 %) 36 ( 28

– 56 ;

N/A ) Very highly toxic ( 42974904 )

Bluegill sunfish ( Lepomis

macrochirus ) 96

- hr, flow

through TGAI ( 96.8 %) 52.7 ( 47.1

– 59.9 ; N/A ) Very highly toxic ( 42974905 )

CL: Confidence limits. LC 50 : Lethal concentration to 50% of the population.

1 Bolded values represent the most sensitive toxicity endpoints for freshwater fish exposed to parent fluazinam and

therefore will be used in risk estimation

. 2 Based on mean measured concentrations

. 3 If p rob it slope data were not available

, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the probability of an individual effect (Urban and Cook 1986).



### Two chronic toxicity studies are available for fluazinam conducted on freshwater fish ( Table

3.16 ) . In an early life stage study with the fathead minnow ( Pimephales promelas , MRID 44807327), fish were exposed to mean measured concentrations ranging from 1.6

– 23 μg a.i

. /L (including nega tive and solvent controls) . Survival at hatch was significantly reduced (p<0.05) at the highest treatment concentration only (23 μg a.i/L). Percent larval survival, total length, and dry weight were all significantly reduced (p<0.05) from the control in the two highest treatment concentrations. The NOAEC and LOAEC for this study were determined to be 5.3 and 10 μg a.i/L, respectively, based on reductions in larval survival and growth measurements. This study is classified as acceptable.

In a fish ful l life cycle toxicity study conducted with the fathead minnow (MRID 44807329), fish were exposed to mean measured concentrations ranging from 0.69

– 14 μg a.i

. /L (including negative and solvent controls). For the F 0 

### generation, percent hatch, 30

- day post hatch survival,

61

- day post hatch survival, and test termination (day 278) survival were all significantly reduced from the control at the highest treatment concentration (14 μg a.i

. /L). Mean total length at 30 days was significantly reduced from the nega tive control and male wet weight was significantly reduced from the control in the three highest test concentrations (2.9, 6.4, and 14 μg a.i

. /L). The number of spawns per female as significantly reduced from the control in the two highest

treatment conce ntrations.

For the F 1 

### generation, percent hatch was significantly reduced from the control in all but the lowest treatment concentration (0.69 μg a.i/L). Fish in the highest treatment concentration had

their 30

- day post hatch length significantly reduced and 30

- day post hatch wet weight was significantly reduced from the control in the two highest treatment concentrations.

Physical and behavioral abnormalities noted in the F 0 

### fish included scoliosis, cranial malformations, and protruding eyes. These effects occurred in the l owest and two highest- Page 48 of 137

- 

### treatment concentrations. There was one fish in the F 1 

### generation that exhibited scoliosis. The NOAEC and LOAEC for this study were determined to be 0.69 and 1.4 μg a.i

. /L, respectively

based on F 1 

### hatching success. This study is c lassified as acceptable.

Table 3. 9 . Summary of Chronic Toxicity Data for Freshwater Fish Exposed to Fluazinam

Species Study Type Test Substance (Purity) NOAEC;

LOAEC ( μ g a.i /L) 1 ,2 Endpoints (MRID)

Fathead minnow Pimephales promelas 32

- d Early Life Stage TGAI (96.8 %) 5.3; 10 Larval s urvival ( 44807327 )

278

- d Full Life Cycle TGAI ( 96.8 %) 0.69; 1.4 F 1 Hatching

success ( 44807329 )

N/A: Not applicable or available.

1 Bolded values represent the most sensitive toxicity endpoints for freshwater fish exposed to parent fluazinam. And

therefore will be used in risk estimation.

2 Based on mean measured concentrations



### 3.3.1.2. Toxicity to Freshwater Invertebrates

There are two acu te toxicity tests available for the freshwater invertebrate Daphnia magna ( Table 3.17 ) . In a static study (MRID 42208410), the EC 50 

### was determined to be 180 μg a.i/L. Although sublethal effects were noted to occur at all test concentrations during the st udy, the specific types of sublethal effects were not noted. This study was classified as supplemental, due to its absence of a negative control (only a solvent control was used in the study). It is noted that this endpoint exceeds the solubility limit of fluazinam of 72 μg a.i/L

In a second study conducted under flow

- through exposure system (MRID 42974906), daphnia were exposed to mean measured concentrations ranging from 34

– 260 μg a.i/L (including negative and solvent controls) . At test termination, there was 5% mortality in the lowest and third highest treatment concentrations (34 and 94 μg a.i/L, respectively), 15 % in the second highest treatment concentration (150 μg a.i/L), and 65% in the highest treatment concentration (260 μg a.i/L ). Sublethal effects were observed in all but the second lowest treatment concentration and included daphnids observed on the surface of the tank, on the bottom of the tank, and lethargic. The EC 50 

### was determined to be 222 μg a.i/L and this study was cla ssified as acceptable. It is noted that this endpoint exceeds the solubility limit of fluazinam of 72 μg a.i/L

In a static water column test with the sediment dwelling freshwater midge ( Chironomus riparius

, MRID 48571412), 2

- 3 day old midges were exposed to nominal concentrations of fluazinam of control (negative and solvent), 10, 20, 40, 80, 160, and 320 μg a.i/L. Since recoveries of the test chemical varied throughout the 48

- hour study, the initial measured concentrations were used for

the determinatio n of endpoints. The LC 50 

### was determined to be 62.6 μg a.i/L. This study is classified as supplemental due to the nominal test concentrations declining to between 10 and 59% by the end of the study. As a result, this study is only used for qualitative pu rposes. These studies indicate that fluazinam is highly toxic to freshwater invertebrates on an acute exposure basis. Additionally these studes indicate that toxicity was near or exceeded the reported limit of solubility for fluazinam.- Page 49 of 137

- 

### In a chronic life cy cle study conducted with Daphnia magna under a flow

- through system (MRID 44807328), mean measured concentrations were 8.9, 16, 33, 68, and 140 μg a.i/L ( Table

3.18 ) . The mean number of young per female and mean dry weight were significantly reduced (p<0.0 5) at the highest treatment concentration (140 μg a.i/L). Sublethal signs of toxicity included pale coloration, small appearance, and daphnids observed at the bottom of the test vessel. The NOAEC for this study was determined to be 68 μg a.i/L based on t he number of young per female and mean dry weight. This study is classified as acceptable.

Table 3. 10 . Summary of Acute Toxicity Data for Freshwater Invertebrates Exposed to

Fluazinam

.

Species Study Type Test Substance (Purity) E C 50 ( μ g a.i /L) 1,2

(95% CL ; slope ) Toxicity

Classification (MRID)

Water flea ( Daphnia magna ) 48

- hr, static TGAI (98.5%) 180 ( 140

– 222; 3.6 ) Highly toxic (42208410)

48

- hr, flow

through TGAI (96.8%) 222 ( 188

– 300; 2.8 ) Highly toxic (00159915) Freshwater midge

Chironomus riparius 48

- hr, static TGAI (97.8 %) 62.6 3

(2 51.9

– 75.0;

6.0 ) Very highly toxic ( 48571412 )

CL: Confidence limits. NA: Not available or applicable.

1 Bolded values represent the most sensitive toxicity endpoints for freshwater invertebrates exposed to parent

fluazinam and therefore will be used in risk estimation.

2 Based on mean measured concentrations

3 This study and resultant endpoint were classified as be ing only for qualitative use only and therefore will not be

used in risk estimation.



### Table 3. 11 . Summary of Chronic Toxicity Data for Freshwater Invertebrates Exposed to

Fluazinam

.

Species Study Type Test Substance (Purity) NOAEC;

LOAEC ( μ g a.i /L) 1 ,2 Endpoints (MRID)

Water flea ( Daphnia magna ) 21

- day Life Cycle TGAI (96.8 %) 68 ; 140 Number of young per female and

dry weight ( 44807328 )

1 Bolded values represent the most sensitive toxicity endpoints for freshwater invertebrates exposed to parent

fluazinam and therefore will be used in risk estimation.

2 Based on mean measured concentrations



### 3.3.1.3

. Toxicity to Estuarine/Marine Fish

An acute toxicity study with the sheepshead minnow ( Cyprinodon variegatus, MRID 44807325) was submitted in support of fluazinam ( Table 3.19 ) . Fish were exposed to fluazinam at mean measured concentrations ranging from 80

– 520 μg a.i/L (including negative and solv ent controls) . Complete mortality was observed at the three highest treatment concentrations (240, 330, and 520 μg a.i/L, mean measured). In the two highest treatment concentrations, mortality

was observed 10 minutes after the test chemical was added. S ublethal effects included loss of equilibrium and was observed at the 240 μg a.i/L treatment concentration. The LC 50 

### for this study was determined to be 120 μg a.i/L and this study is classified as acceptable. The results of- Page 50 of 137

- 

### this study indicate that flu azinam is highly toxic to estuarine/marine fish on an acute exposure basis. It is noted that this endpoint is above the reported solubility limit for fluazinam (72μg a.i/L).

A chronic early life stage study is available for fluazinam that was conducted on the sheepshead minnow (MRID 45822102

, Table 3.20 ). Fish were exposed to mean measured concentrations of negative and solvent controls, 1.6, 2.8, 5.9, 12, and 26 μg a.i/L. There were no treatment related reductions from the control for any variable at any of the treatment concentrations. Furthermore, there were no other sublethal effects including effects on behavior or appearance, reported for the study. Due to the absence of any treatment related effects, the NOAEC and LOAEC for this study were dete rmined to be 26 and >26 μg a.i/L, respectively. This stud y is classified as acceptable.

Table 3. 12 . Summary of Acute Toxicity Data for Estuarine/Marine Fish Exposed to

Fluazinam

.

Species Study Type Test Substance (Purity) E C 50 ( μ g a.i /L) 1,2 ,3

(95% CL ; slope ) Toxicity

Classification (MRID) Sheepshead minnow ( Cyprinodon variegatus ) 96

- hour,

flow

through TGAI (96.8 %) 120 ( 80

– 240; N/A ) Highly toxic ( 44807325 )

1 Bolded values represent the most sensitive toxicity endpoints for estuarine/marine fish exposed to parent fluazinam

and therefore will be used in risk estimation

. 2 Based on mean measured concentrations.

3 Probit slope data were not available; therefore, the def ault value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the probability of an individual effect (Urban and Cook 1986).



### Table 3. 13 . Summary of Chronic Toxicity Data for Estuarine/Marine Fish Exposed to

Fluazinam

.

Species Study Type Test Substance (Purity) NOAEC;

LOAEC ( μ g a.i /L) 1,2 Endpoints (MRID)

Sheepshead minnow ( Cyprinodon variegatus ) 35

- d Early Life Stage TGAI (96.8%) 26; >26 All variables ( 45822102

, 48571408 )

1 Bolded values represent the most sensitive toxicity endpoints for estuarine/marine fish exposed to parent fluazinam

and therefore will be used in risk estimation.

2 Based on mean measured concentrations.



### 3.3.1.4. Toxicity to Estuarine/Marine Invertebrates

Two acute estuarine/marine invertebrate studies have been submitted in support of fluazinam ( Table 3.21 ) . In a 96

- hour oyster shell deposition study with the eastern oyster ( Crassostrea virginica , MRID 44807324), oysters were exposed to mean measured concentrations of 0.84

– 9.7 μg a.i/L (including negative and solvent controls) . The EC 50 

### was determined to be 4.7 μg a.i/L. Sublethal effects included reduced feeding that was observed at the highest treatment

concentration (9.7 μg a.i/L). This study is classified as acceptable.

In another study conducted with the saltwater mysid ( Americamysis bahia , MRID 44807326).- Page 51 of 137

- 

### Mysids were exposed to mean measured concentrations ranging from 8.0

– 70 μg a.i/L (including negative an d solvent controls) . Complete mortality occurred in the highest treatment concentration with 45% in the second highest and 10% mortality in the third highest treatment concentrations (70, 40, and 25 μg a.i/L, mean measured). Sublethal effects included lo ss of equilibrium, erratic swimming, and darkened pigmentation that occurred in the three highest

treatment concentrations. The LC 50 

### was determined to be 39 μg a.i/L and this study is classified as acceptable. These studies classify fluazinam as very hig hly toxic to estuarine/marine invertebrates on an acute exposure basis.

A chronic life cycle test was submitted in support of fluazinam conducted with mysid shrimp (MRID 45822101

, Table 3.22 ) . Mysids were exposed under flow through conditions to mean

mea sured concentrations of control, solvent control, 0.25, 0.52, 1.0, 2.0, and 3.9 μg a.i/L. At study termination on Day 28, the mean number of young per female per day was significantly different from the control at the highest treatment concentration (3.9 μg a.i/L). There were no other treatment related effects on survival, total number of young or length and weight measurements. It was not noted in the study report if there were findings of abnormal appearance or behavior during the study. Based on th e effects of reproductive success (mean number of young per female per day), the NOAEC and LOAEC for this study were determined to be 2.0 and 3.9 μg a.i/L, respectively. This study was classified as acceptable.

Table 3. 14 . Summary of Acute Toxicity Data for Estuarine/Marine Invertebrates Exposed

to Fluazinam

.

Species Study Type Test Substance (Purity) E C 50 ( μ g a.i /L) 1,2 ,3
(95% CL; slope) Toxicity

Classification (MRID) Eastern oyster

Crassostrea virginica 96

- hour,

flow

through TGAI (96.8%) 4.7 (3.6

– 6.0; N/A) Very highly toxic (44807324)

Saltwater mysid Americamysis bahia 96

- hour,

flow

through TGAI (96.8%) 39 (34

– 45; N/A) Very highly toxic (44807326)

1 Bolded values represent the most sensitive toxicity endpoints for estuarine/marine invertebrates exposed to parent

fluazinam and therefore will be used in risk estimation.

2 Based on mean measured concentrations.

3 Probit slope data were not available; therefore, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the probability of an individual effect (Urban and Cook 1986).



### Table 3. 15 . Summary of Chronic Toxicity Data for Estuarine/Mar ine Invertebrates Exposed to Fluazinam

.

Species Study Type Test Substance (Purity) NOAEC;

LOAEC ( μ g a.i /L) 1,2 Endpoints (MRID)

Saltwater mysid Americamysis bahia 28

- d Life Cycle TGAI (98.4%) 2 .0 ; 3.9 Reproductive

success (45822101

, 48571407 )

1 Bolded values represent the most sensitive toxicity endpoints for estuarine/marine invertebrates exposed to parent

fluazinam and therefore will be used in risk estimation.

2 Based on mean measured concentrations.- Page 52 of 137

- 

### 3.3.1.5. Toxicity to Sediment Dwelling Organisms

There are two freshwater 10

- day sediment toxicity studies available for fluazinam ( Table 3.23 )

. In one study conducted with the freshwater midge ( Chironomus tentans , MRID 48571413), organisms were exposed to mean measured sediment concentrations of contr ol, solvent control, 0.31, 0.73, 2.0, 4.7, and 12 mg a.i/kg sediment. Survival ranged from 90

– 96% across the controls and all treatment concentrations at study termination. Mean dry weight was not

det e rmined to be significantly different (p<0.05) from the negative control at any treatment concentration yet the value at the highest concentration represented a 25% reduction from the negative control. This study therefore determined the LC 50 

### and NOAEC for survival to be >12 and 12 mg a.i

. /kg sediment, res pectively b ased on mean measured sediment concentrations and >343 and 343 mg a.i/kg sediment based on organic carbon (OC)

- normalized sediment

concentrations. The EC 50 

### and NOAEC for weight were the same values as those determined to survival. This study i s classified as acceptable.

In a second 10

- day study conducted with the freshwater amphipod ( Hyalella azteca , MRID 48571414), organisms were exposed to mean measured sediment concentrations of control, solvent control, 0.0076, 0.0355, 0.14, 0.67, and 4. 6 mg a.i/kg sediment. Survival ranged from 69

– 94% across the controls and all treatment concentrations at study termination. A definit i ve LC 50 

### was not a c h ie ved due to no effects 50% or greater but the NOAEC for mean measured

sediment concentrations and OC

- normalized sediment concentrations were 0.14 and 4.0 mg a.i/kg sediment, respectively. This study is classified as acceptable.

There are no estuarine/ma rine sediment studies available for fluazinam.

Table 3. 16 3 . Summary of Sub

- chronic Toxicity Data for Freshwater Sediment

- Dwelling Invertebrates Exposed to Fluazinam

.

Species Study Type Test

Substance

(Purity) Sediment L C 50 (mg a.i / kg

sediment ) 1
(95% CL; slope) Pore

water
LC 50 (mg a.i/L) Sediment

NOAEC (mg a.i/kg sediment) 1,2 Pore

water
NOAEC (mg a.i/L) MRID

Freshwater midge

Chironomus

tentans 10

- day,

whole

sediment TGAI (99.3%) Mean measured = >12 (N/A; N/A)

OC

- normalized =

> 343 (N/A; N/A) >0.24 mg a.i/L

(N/A; N/A) Mean

measured =

12

OC

normalized =

343 24 48571413

Freshwater amphipod Hyalella

azteca 10

- day,

whole

sediment TGAI (99.3%) Mean measured

= >4.6 (N/A; N/A)

OC

- normalized =

> 130 (N/A; N/A) >0.090 mg a.i/L

(N/A; N/A) Mean

measured =

0.14

OC

normalized =

4.0 24 48571414

1 Bolded values represent the most sensitive toxicity endpoints for fresh water sediment

- dwelling invertebrates exposed to parent fluazinam and therefore will be used in risk estimation.

2 Based on mean measured concentrations.- Page 53 of 137

- 

### 3.3.1.6. Toxicity to Aquatic Plants

Three aquatic algal toxicity tests are available for fluazinam ( Table 3.24 ). The first was

conducted with the freshwater green algae

, S elenastrum capricornutum (MRID 44807334 ). This study determined a 96 hour EC 50 

### of 180μg a.i/L and a NOAEC of 48 μg a.i/L based on cell density . Due to a higher light intensity being used for this study than what is guideline recommended, this study was classified as supplemental although this deviatio n does not limit the utility for this study in risk estimation.

In a study conducted with the cyanobacteria Anabaena flos

- aquae (MRID 45822106), initial measured concentrations were negative and solvent controls, 12, 26, 36, 72, and 200 μg a.i/L.

Due to no reductions from control in cell density being 50% or greater, the EC 50 

### for this study was determined to be >200 μg a.i/L. The NOAEC was determined to be 72 μg a.i/L. This study is classified as acceptable.

In a study conducted with the marine d iatom Skeletonema costatum (MRID 48612301), initial

measured concentrations (which the endpoints were expressed in) were negative and solvent controls, 0.13, 0.24, 0.49, 0.8, 2.2, 4.7, 7.7, and 17 μg a.i/L. Cells exposed to the two highest

treatment conce ntrations were observed to have thin cell walls. The NOAEC and EC 50 

### were determined to be 0.49 and 1.1 μg a.i/L, respectively. This study is classified as acceptable.

There were no acceptable vascular aquatic plant studies available for fluazinam.

Tabl e 3. 24 Summary of Toxicity Data for Nonvascular Aquatic Plants Exposed to

Fluazinam

.

Species Study Type Test Substance (Purity) NOAEL; E C 50 ( u g a

. i

. /L) (95% CL) 1,2 Effect ( MRID)

Green alga ( Pseudokirchneri ella subcapitata ) 96

- hr, static TGAI (97 %) 48; 180 (160

– 200) Cell density ( 44807334 )

Cyanobacteria ( Anabaena flos

aquae ) 96

- hr, static TGAI (98.4 %) 72; >200 (N/A) Cell density ( 45822106 )

Marine diatom ( Skeletonema

costatum ) 96

- hr, static TGAI (99.3%) 0.49; 1.1 0 (0.49

– 2.4 0 ) Cell density ( 48612301)

N / A Not available.

1 Bolded values represent the most sensitive toxicity endpoints for nonvascular aquatic plants exposed to parent

fluazinam and therefore will be used for risk estimation

. 2 Based on mean measured concentrations.



### 3. 3.2

. Terrestrial Effects Characterization

A summary of the most sensitive terrestrial animal toxicity data for fluazinam , based on a current Agen cy review of all submitted data

, is provided in Table 3.25 through Table 3. 29 and is

discussed further in Sections 3.3.2.1 through 3.3.2.3 . The available data indicate that fluazinam- Page 54 of 137

- 

### TGAI is slightly toxic to birds on an acute oral basis, practically non

- toxic to birds on a subacute dietary exposure basis , and practically non

- toxic to mammals on an acute oral basis. There were

effects on 14

- day survivor weight in both avian reproduction studies. Multi

- generation chronic mammalin toxicity studies indicate that fluazinam decreased the number of implantation sites

and descreased the litter sizes. Fl uazinam i s also p ractically non

- toxic to young adult honey

bees ( Apis mellifera ) on an acute contact exposure basis. D efinit i ve EC 25 

### and NOAEC values

were not established in available terrestrial plant studies.

3.3.2.1. Toxicity to Birds

There were three acceptable acut e oral studies submitted in support of fluazinam ( Table 3.25 )

. In one study conducted with the mallard duck ( Anas platyrhynchos , MRID 42248622), the LD 50 

### was determined to be > 4190 mg a.i/kg bw. On day 2 of the study, female birds at the highest test concentration (4190 mg a.i/kg bw, mean measured) appeared subdued. There were no other sublethal effects noted during the study. There were no treatment related effects on body w eight and food consumption.

In a second study conducted with the northern bobwhite quail ( Colinus virginianus , MRID 42248623), the LD 50 

### was determined to be 1782 mg a.i/kg bw. The test concentrations used in the study were control, 500, 1000, and 2000 mg a.i/kg bw (nominal concentrations). There were no mortalities that occurred in the negative control and the lowest test concentration. There was 10% mortality and 60% mortality that occurred in the 1000 and 2000 mg a.i/kg bw treatment concentrations, respectively. Body weight gain and food consumption was reduced at the highest treatment concentration during the study while there were no changes from control for

these variables in the other treatment concentrations. Sublethal effects included three b irds in the highest treatment becoming subdued and having a ruffled appearance. These two studies classify fluazinam as slightly toxic to birds on an acute oral basis.

An acute oral study a passerine species (Zebra finch, Taeniopygia guttata , MRID 485714 09) was submitted in support of fluazinam. The study was conducte d as a limit test in which birds were given either control or a limit dose of 2000 mg a.i/kg bw. Piloerection was first noted

appro x imately. 30 minutes after dosing for four birds in the 20 00 mg a

. i

. /kg treatment group. One female bird was found dead on Day 2. The three remaining birds had recovered by Day 3 of the test. There were no observed effects on feed consumption and no statistically

- significant differences compared to the control in body weight. There was one bird that regurgitated a portion of the test material and was replaced by a pre

- fasted bird that did not proceed to regurgitate. As the level of mortality did not exceed 50% the LD 50 

### was estimated to be >2000

mg a

. i

. /kg bw.

T wo acceptable avian sub

- acute dietary studies were submitted for fluazinam. In studies submitted with the bobwhite quail and mallard duck, the LC 50 

### values were determined to be >10500 and >10600 ppm, respectively (MRIDs 42248624 and 42248625). In the bob white quail study, one mortality occurred at the third highest treatment concentration (2480 ppm) and one at the second highest treatment concentration (5230 ppm). The sole mortality in the mallard duck study occurred at the highest treatment concentratio n (10600 ppm). There was a reduction in body weight gain in the two highest treatment concentrations and a reduction in food- Page 55 of 137

- 

### consumption at the highest treatment concentration in the mallard study. There were no treatment related effects on body weight g ain and food consumption in the bobwhite quail study. There were no sublethal effects that occurred in either of the studies. These studies classify fluazinam as practically non

- toxic to birds on a sub

- acute dietary basis.

There are two acceptable avian reproduction studies submitted in support of fluazinam ( Table

3.26 ) . In one study conducted with the bobwhite quail (MRID 44807323), the NOAEC was determined to be 200 ppm based on 14

- day old survivor weight. The test had two phases of definitive testing with Phase I testing at concentrations of control, 750, 1500, and 5000 ppm. The level of mortality observed in this study necessitated that a second study be conducted with lower treatment concentrations to examine the reproductive endpoints captured in the study. The second phase of the study was conducted at treatment concentrations of control, 50, 200, 350, and 500 ppm (nominal concentrations). In this second phase of the study, there were no sublethal effects or mortalities observed at any treatmen t concentration. There were no treatment related effects on any variable of the study with the exception of 14

- day old survivor weight. This effect coincides with a slight decrease in mean hatchling body weight. The NOAEC and LOAEC for this study theref ore were determined to be 200 and 350 ppm, respectively.

In a second avian reproduction study conducted with the mallard duck (MRID 44831907), birds were dosed in two phases, with the first phase of the study exposing birds to higher

concentrations of fl uazinam. These treatment concentrations in the first phase (control, 750, 1500, and 5000 ppm) led to treatment related mortalities in the highest treatment group and birds that did not die in this group were euthanized by week 9. To examine the effects o n reproductive parameters, the second phase of the study tested at lower concentrations (control, 50, 200, 350, and 500 ppm). In this second phase of the study, there were no treatment related mortalities at any concentration tested. When compared to the negative control, there were no treatment related reductions in body weight or feed consumption. There was a statistically significant reduction (p<0.05) from the negative control in 14

- day old survivor weight in the highest treatment concentration (500 ppm) that represented a 10% reduction from the control. There were no other statically significant reductions from control for any other variable of the study nor were there any clinical signs of toxicity noted. The NOAEC and LOAEC for this study, based

on 14

- day old survivor weight, were therefore determined to be 350 and 500 ppm, respectively.

Table 3. 17 5

. Summary of Acute and Sub

- acute Toxicity Data for Birds Exposed to

Fluazinam

.

Species Study Type Test Substance (Purity) LD 50 (mg/kg bw) or LC 50 (mg/kg diet) ; (95% CI; slope) 1,2 Toxicity Classification (MRID)

Bobwhite quail ( Colinus virginianus ) Acute oral toxicity TGAI (95.3%) 14

- d LD 50 : 1782 (1321

– 3595; 5.25) Slightly toxic (42248623)

Mallard duck ( Anas platyrhynchos ) Acute oral toxicity TGAI (95.3%) 14

- d LD 50 : > 4190 (N/A; N/A) Practically nontoxic (42248622)

Zebra Finch ( Taeniopygia guttata Acute oral toxicity TGAI (99.3%) 14

- d LD 50 : > 2000 (N/A; N/A) Practically nontoxic (48571409) Bobwhite quail ( Colinus virginianus ) Subacute dietary toxicity TGAI (95.3%) 8

- d L C 50 : > 10,500 (N/A; N/A) Practically nontoxic (42248624)- Page 56 of 137

- Species Study Type Test Substance (Purity) LD 50 (mg/kg bw) or LC 50 (mg/kg diet) ; (95% CI; slope) 1,2 Toxicity Classification (MRID)

Mallard duck ( Anas platyrhynchos ) Subacute dietary toxicity TGAI (95.3%) 8

- d L C 50 > 10,600 (N/A; N/A) Practically nontoxic (42248625) N/A=not applicable

. 1 Bolded values represent the lowest definitive toxicity endpoint and are used in risk estimation

2 Based on mean measured concentrations.



### Table 3. 26 . Summary of Chronic Toxicity Data for Birds Exposed to Fluazinam

.

Species Study Type Test Substance (Purity) NOAEC;

LOAEC ( mg/kg diet ) Endpoints (MRID)

Northern bobwhite quail Colinus virginianus Chronic reproduction TGAI (97.0%) 200; 350 14

- d survivor weight ( 44807323 )

Mallard duck ( Anas platyrhynchos ) Chronic reproduction TGAI (97.0%) 350; 500 14

- d survivor weight (44807323)

Bolded values represent the lowest definitive toxicity endpoint and are used in risk estimation



### 3.3.2.2. Toxicity to Mammals

In an acute oral exposure study to the laboratory rat ( Rattus norvegicus

, MRID 42248603), rats were orally dosed once with control, 2500, 3200, 4000, or 5000 g a.i/kg bw technical fluazinam.

The LD 50 

### was determined to be 4100 mg a.i/kg bw. Clinical signs of toxicity included piloerection, abnormal body carriage, abnormal gait , lethargy, pallor of extremities, and diarrhea. This study is classified as acceptable and indicates that fluazinam is slightly toxic to mammals

on an acute oral basis.

In a 2

- generation reproduction study with the laboratory rat (MRIDs 42248619, 422084 06, 42248618) fluazinam was administered in the diet to rats at control, 0, 20, 100, or 500 ppm.

There were no deaths or clinical sings of toxicity that were treatment related. Mean body weight, body weight gain, food consumption and food efficiency amon g all groups of F 0 

### males and F 0 

### females treated with 20 or 100 ppm and F 0 

### males treated with 500 ppm were similar to the control group means. The F 0 

### females treated with 500 ppm of the test diet had significantly decreased (82% of control value, p< 0.001) overall body weight gain and food consumption (96% of control value, p< 0.05) for the premating period. The F 1 

### animals treated with 500 ppm had significantly decreased mean body weight gain and food consumption values that were 88% and 92% (p< 0.001 an d p< 0.01) and 85% and 93% (p< 0.001 and p< 0.01) of the control values for males and females, respectively for the premating period. The relative liver weights of F 0 

### and F 1 

### males and F 0 

### females treated with 500 ppm were significantly increased compared t o the control group.

The number of implantation sites observed in F 1 

### dams was decreased significantly (p< 0.05) at 500 ppm (12.2 vs 15 .3 in controls) and marginally at 100 ppm (13.1 vs 15.3 in controls). Mean- Page 57 of 137

- 

### litter size on day 4 was slightly decrease d in the 500 ppm group for F 1 

### litters, but was significantly decreased (p<0.05) in the 500 ppm group for F 2 

### litters (9.8 + 3.7 for 500 ppm vs

12.4 + 3.0 for controls). The NOAEL for reproductive toxicity is 100 ppm (10.6 mg/kg/day) and

the LOAEL is 500 ppm (53.6 mg/kg/day), based on a decreased number of implantation sites and

decreased litter sizes to day 4 post partum for F 1 

### females (F 2 

### litters).

Table 3. 18 7 . Summary of Acute and Chronic Mammalian Toxicity Data for Rats Exposed

to Fluazinam

. 1,2

S pecies Study Type Acute Chronic

LD 50

( mg/kg bw ) Toxicity

Classification (MRID) NOAEC ( mg/kg diet )

NOAEL (mg / kg bw/day) Endpoints (MRID)

Norway rat

( Rattus norvegicus ) Acute oral toxicity 14

- d LD 50 = 4100 mg a.i/kg bw Practically

nontoxic ( 42248603 ) 1 NOAEL = 10.6 mg a.i/kg/day

LOAEL = 53.6 mg a.i/kg/day Decreased number of implantation

sites and decreased

litter sizes ( 42248619, 42208406,

42248618 )

1 Mammalian toxicity data for fluazinam TGAI provided and reviewed by EPA Health Effects Division.

2 Bolded values represent the most sensitive toxicity endpoints available for ecological risk assessment.



### 3.3.2.3

. Toxicity to Beneficial Insects

A combination acute contact and acute oral study conducted on the honey bee ( Apis mellifera) was submitted in support of fluazinam (MRID 42208411

, Table 3.28 ). For the acute contact portion of the study, technical fluazinam as well as a formulated product o f fluazinam (49.7% a.i) were tested. For the acute oral part of the study, only technical fluazinam was tested. The

48

- hour acute contact LD 50 

### with technical fluazinam was >200 μg a.i/bee while the formulated product LD 50 

### was determined to be >4 μg a.i/b ee. The acute oral LD 50 

### was >100 ug a.i/bee which classifies fluazinam as practically non

- toxic to honey bees on an acute exposure basis. This study is classified as acceptable for the technical contact and acute oral portions of the study but supplement al for the formulated acute contact part of the study due to the bees not being dosed high enough.

There are two subchronic earthworm toxicity studies for available for fluazinam. In a 14

- day study conducted with Eisenia fetida (MRID 44807336), formulate d fluazinam (38.4%) was exposed to earthworms at control, 138, and 1376 mg a.i/kg soil. The 14

- day LC 50 

### was determined to be >1376 mg a.i/kg soil. The NOAEC could not be determined based on body weight reductions at all treatment concentrations. There w ere no clinical signs of toxicity reported. In a second 28

- day study conducted with the same species of earthworm with technical fluazinam (97.3% a.i) earthworms were exposed to fluazinam at concentrations of control, 10, 100, and 1000 mg a.i/kg soil. Th e 28

- day LC 50 

### was determined to be >1000 mg a.i/kg soil. The NOAEC (based on body weight reductions), was determined to be 10 mg a.i/kg soil (the lowest treatment concentration). Both studies were classified as supplemental as both were conducted- Page 58 of 137

- 

### as non

- guideline status.

Table 3. 1 9 8. Summary of Acute Toxicity Data for Beneficial Insects Exposed to Fluazinam

.

Species Study Type (TGAI or EP) LD 50 (μg a.i

. /bee) Toxicity Classification (MRID)

Honey bee ( Apis mellifera ) Acute oral and contact toxicity (TGAI) > 100 (oral) >200 (contact) Practically nontoxic ( 42208411 )
Acute contact toxicity (EP) >4 ( 42208411 )

EP = End use product



### 3.3.2.4. Toxicity to Terrestrial Plants

A Tier I seedling emergence study is available for formulated fluazinam (41.5% a.i, MRID 46172801). Eleven species were assessed and the test substance did not exhibit a 25% or greater reduction compared to the control on any species for any of the variables examined. A Tier II test was requested however since a NO A EC or an EC 05 

### was not established. There were no phytotoxic effects observed during the study for any of species. This study is classified as acceptable. A companion vegetative vigor study (MRID 46172802) was submitted alongside the seedling emergence study and was found to be a cceptable

.

Table 3. 20 9 . Summary of Tier I Toxicity of Fluazinam to Non

- target Terrestrial Plants.

Crop Type of Study Species E C 25 (lb s a

. i

. /A) NOAE L

or E C 05 (lb s a

. i

. /A) Endpoint

Affected MRID

Seedling Emergence ( formulated fluazinam )

Monocots Corn >0.78 N/D N/A

46172801 Oat >0.78 N/D N/A

Onion >0.78 N/D N/A Ryegrass >0.78 N/D N/A

Dicots Cabbage >0.78 N/D N/A

Lettuce >0.78 N/D N/A

Carrot >0.78 N/D N/A

Tomato >0.78 N/D N/A

Radish >0.78 N/D N/A Soybean >0.78 N/D N/A

Cucumber >0.78 N/D N/A Vegetative Vigor (formulated fluazinam)

Monocots Corn >0.78 0.78

46172801 , 48708701 Oat >0.78 0.78 N/A

Onion >0.78 0.78 N/A Ryegrass >0.78 0.78 N/A

Dicots Cabbage >0.78 0.78 N/A

Lettuce >0.78 0.78 N/A

Carrot >0.78 0.78 N/A

Tomato >0.78 0.78 N/A

Radish >0.78 0.78 N/A Soybean >0.78 0.78 N/A- Page 59 of 137

- Crop Type of Study Species E C 25 (lb s a

. i

. /A) NOAE L

or E C 05 (lb s a

. i

. /A) Endpoint

Affected MRID

Cucumber >0.78 0.78 N/A N/D = not determined, N/A = not applicable



### 3.3.3. Estimates of Degradate Toxicity

As described in Section 3.2.1.2

. , fluazinam degrades by various routes in the environment up to eight different degradation products, depending on the route of degradation ( Table 3.4 ). The ECOSAR (v1.0) module of E PI S UITE (v. 4.0 ) was employed to estimate the toxicity of these degradates as compared to registrant submitted data of parent fluazinam. ECOSAR uses structure activity relationsh ips to predict the toxicity of compound s that share similar structural

moieties. For each degradate of fluazinam, ECOS AR returned at least 2 ECOSAR classes of estimates that refer to the toxicity that is predicted from a particular moiety. In cases where multiple estimates of toxicit y for a particular taxa are pre dicted for a degradate, the most

sensitive estimate was ta bulated below in Table 3.3 1

. Table 3.30 shows the ECOSAR classes for each degradate for which toxicity es t imates were predicted.

Table 3.30

. ECOSAR classes with toxicity est i mates available for each degradate of

fluazinam.
Fluazinam Degradate ECOSAR Cla sses with Toxicity Estimates

CAPA Dinitrobenzenes

- acid, Halopyr i dines

- acid

DAPA Anilines (amino

- meta), Halopyr i dines

AMPA Anilines (aromatic amines), Halopyr i dines

DCPA Dinitrobenzenes

- acid, Halopyr i dines

- acid

MAPA Anilines (aromatic amines), Halopyr i dines

HYPA Phenols, Dinitrophenols, Halopyr i dines

G

- 504 Imidazoles

- acid, Halopyr i dines

- acid

SDS

- 67200 Anilines (amino

- meta), Halopyr i dines



### Table 3.3 1

. ECOSAR predicted toxicity (μg a

. i

. /L) of the degradates of fluazinam 3

Stressor →

Taxa (Exposure

type) ↓ Fluazinam 4 Fluazinam 5 CAPA DAPA AMPA DCPA MAPA HYPA G

504 SDS

67200

FW Fish

(acute) 36 434 4117 378 406 3893 406 417 3678 1 346

FW Inverts (acute) 180 1086 13229 1 612 1024 1 17393 1024 1 1467 7533 1 1035

FW Algae

(acute) 180 537 9,240 1 931 13265 1 19137 13265 1 49879 1 N/A 1256

SW Fish (acute) 120 1739 33908 1 N/A N/A 82824 N/A 13954 1 N/A N/A

FW Fish (chronic) 0.69 14 411 166 7 1657 7 13 184 1 382

FW Inverts

(chronic) 68 30 2 2,902 18 2 14 2365 2 14 104 2 89 1,2 25

SW Fish >26 156 2 3242 2 N/A N/A 8630 1 N/A 6499 2 N/A N/A- Page 60 of 137

- Stressor →

Taxa (Exposure

type) ↓ Fluazinam 4 Fluazinam 5 CAPA DAPA AMPA DCPA MAPA HYPA G

504 SDS

67200

(chronic)

1 Indicates that the stressor may not be soluble enough to measure this predicted effect

2 Indicates that the toxicity value was determined from a predicted structure activity relationship using established

acute

- to

- chronic ratios (ACRs)

3 The lowest toxicity estimate for a given taxa was used when estimates for more than one ECOSAR class were yielded for a given degradate.

4 Data in this column refer to registrant submitted studies for fluazinam deem ed suitable for risk estimation. These values are included in the table for comparison purposes against the ECOSAR predicted endpoints.

5 Data in this column refer to ECOSAR estimates of toxicity for parent fluazinam



### 3.3. 4

. Review of Incident Data

The Ecological Incident Inf ormation System (EIIS)

, which is maintained by the Agency’s Office of Pesticide Programs, was searched to determine if ecological incidents have been reported for

fluazinam

. Based on a search of EIIS conducted in March 2013

, there were no incidents

associated with fluazinam were reported.

The American Bird Conservancy (ABC) Avian Incident Monitoring System (AIMS) was searched in March 2013 and returned no records of incidents associated with fluazinam (ABC

, 2007).

A search of the Incide nt Database System (IDS) maintained by OPP’s Information Technology

and Resour ce Manag ement Division (ITRMD) conducted in March 2013 yielded no incident s for fluazinam in the main database nor in the aggregate incident module. Because of limitations in

th e incident reporting system, the lack of additional incident reports cannot be construed as the absence of incidents from the registered use of fluazinam.



## 4. Risk Characterization

4.1. Screening

- Level Risk Quotient (RQ) Values

This screening

- level ass es sment of the labeled use s of fluazinam relies on the deterministic RQ method to provide a metric of potential risks. The RQ provides a comparison of exposure estimates to toxicity endpoints ( i.e. , the estimated exposure concentrations are divided by acute and chronic toxicity values , respectively ). The resulting unitless RQ values are compared to the Agency’s LOCs, as shown in Table s 4.1 through Table 4. 18

. The LOCs are used by the Agency to indicate when the use of a pesticide, as directed by the label, has the potential to cause adverse

effects to non

- target organisms. In this assessment, RQ s that exceed the non

- listed species LOC

also exceed the listed species LOC.

T ables 4.1

– 4.17 provide the resulting, screening

- level RQ values, for taxa with suff icient data. Note that with plants, unlike with animals, RQ values are not presented for acute versus chronic risk; instead, RQ values are presented for listed and nonlisted species based on a comparison of a- Page 61 of 137

- 

### given EEC to NOAEL and E C 25 

### /EC 50 

### values, respectively. A discussion of the RQ values for

fluazinam and of other information that provides context for the interpretation of potential risk to various taxa is presented in the Risk Description in Section 4.2

.

4.1.1. RQ Values for Aquatic O rganisms

Acute risk to freshwater fish and aquatic

- phase amphibians is based on 1 in 10 year peak EECs in the standard pond and the lowest acute toxicity value for freshwater fish

. Chronic risk is based on the 1 in 10 year 60

- day EECs and the lowest chro nic toxicity value for freshwater fish. It is noted that the peak and 60

- day EECs refer to total toxic residues (TTR) of fluazinam and 5 degradates of concern based on their estimated toxicity through ECOSAR ( DAPA, AMPA, MAPA, G

- 504, and SDS

- 67200 )

. Acut e and chronic r isk quotients for freshwater fish are shown

in Table 4.1 . Acute RQs ranged from 0.03

– 1.06 and chronic RQs ranged from 0.46

– 13.49.

One hundred percent (100%) of the fluazinam uses (at least one modeled scenario) exceeded at
least one ac ute risk LOC and exceeded the chronic risk LOC. The probability of an individual chance of effect was estimated using the default slope of 4.5 as a slope was not available from the most sensitive acute freshwater fish toxicity study.

Table 4. 1 . Acute and Chronic RQs for Direct Effects to Freshwater Fish from Fluazinam

TGAI. 1 ,2

Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater Fish

EC 50 = 36 μg a

. i

. /L 60

- day

EECs

(μg

a

. i

. /L) Freshwater

Fish

NOAEC =

0.69 μg

a

. i

. /L

Acute

RQ Probability

of Acute

Effect 3

(1 in ...) Chronic RQ

Apples NC apple Airblast 38.0 1.06 4.18 X 10 8 9.31 13.49

OR apple Airblast 12.8 0.36 4.18 X 10 8 4.04 5.86

PA apple Airblast 32.8 0.91 4.18 X 10 8 6.43 9.32

B rassica (Cole) Leafy Vegetables , plus Turnip

Greens CA cole

crops Soil drench

after transplant 11.6 0.32 4.18 X 10 8 3.96 5.74

FL cabbage Soil drench

after transplant 4.44 0.12 4.18 X 10 8 0.7 6 1.10

FL cabbage Soil incorporp.

(15 cm) 1.54 0.04 4.18 X 10 8 0.3 3 0.47

Bushberry OR

berries Ground 5.73 0.16 4.18 X 10 8 1.74 2.52

Carrots CA row

crops Ground 4.14 0.12 4.18 X 10 8 1.30 1.88

FL

carrots Ground 15.4 0.43 4.18 X 10 8 3.36 4.87

Ginseng MN sugar

beet Ground 5.04 0.14 4.18 X 10 8 1.27 1.84- Page 62 of 137

- Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater Fish

EC 50 = 36 μg a

. i

. /L 60

- day

EECs

(μg

a

. i

. /L) Freshwater

Fish

NOAEC =

0.69 μg

a

. i

. /L

Acute

RQ Probability

of Acute

Effect 3

(1 in ...) Chronic RQ

Lettuce CA

lettuce Ground 1.65 0.05 4.18 X 10 8 0.31 0.46

*Edible

- Podded Legume Vegetables, ex cept peas; *Succulent Bean Crop; *Dry Bean , except Peas and Soybeans MI beans Ground 3.60 0.10 4.18 X 10 8 1.05 1.52

OR snap

beans Ground 1.49 0.04 4.18 X 10 8 0.56 0.82

Bulb Vegetables CA onion Ground 1.16 0.03 4.18 X 10 8 0.65 0.94

GA onion Ground 14.7 0.41 4.18 X 10 8 4.69 6.80

Cucurbit Vegetables,

Melon MI

melons Foliar 19.1 0.53 4.18 X 10 8 4.45 6.45

MO

melons Foliar 40.2 1.12 4.18 X 10 8 8.79 12.74

NJ

melons Foliar 41.4 1.15 4.18 X 10 8 7.89 11.43

Fruiting Vegetable,

Pepper/ Eggplant CA

tomato Foliar 3.73 0.10 4.18 X 10 8 1.30 1.88

FL

peppers Foliar 31.0 0.86 4.18 X 10 8 7.11 10.30

PA

tomato Foliar 33.4 0.93 4.18 X 10 8 8.85 12.83

Peanut NC

peanut Ground 9.70 0.27 4.18 X 10 8 2.57 3.72

Potato ID potato Aerial 1.64 0.05 4.18 X 10 8 0.91 1.32

ME
potato Aerial 3.01 0.08 4.18 X 10 8 1.15 1.67

Soybeans MS soybeans Aerial 6.88 0.19 4.18 X 10 8 2.10 3.04

Turf grasses on golf

courses FL turf Ground 5.98 0.17 4.18 X 10 8 1.16 1.68

PA turf Ground 7.73 0.21 4.18 X 10 8 1.83 2.65

App. = Application

1 Bolded and shaded values indicate an exceedance of an LOC

2 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

3 Slope was not available from most sensitive acute freshwater fish toxicity study and therefore default slope of 4.5 was employed for probably of acute effect estimates.



### Acute risk to freshwater invertebrates is based on 1 in 10 year peak EECs in the standard pond

and the lowest acute toxicity value for freshwater invertebrates

. Chronic risk is based on the 1 in 10 year 21

- day EECs and the lowest chronic toxicity value for freshwater invertebrates. It is noted that the peak and 21

- day EECs refer to total toxic residues (TTR) of fluazinam and 5 degradates of concern based on their estimated toxicity through ECOSAR ( DAPA, AMPA, MAPA, G

- 504, SDS

- 67200 ) Acute and chronic risk quotients for freshwater invertebrates are- Page 63 of 137

- 

### shown in Table 4. 2 . Acute RQs ranged from 0.0 5

– 0.23 and chronic RQs ranged from 0.1

– 0.26

. Fifty percent ( 50 %) of the fluazinam uses (at least one modeled scenario) exceeded at least

one acute risk LOC . There were no uses of fluazinam that exceeded the chronic LOC. The probability of an individual cha nce of effect was estimated using the study der i ved slope of 3.6.

Table 4

. 2

. Acute and Chronic RQs for Direct Effects to Freshwater Invertebrates from

Fluazinam TGAI

. 1

Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

EC 50 = 180 μg a

. i

. /L 21

- day

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

NOAEC = 68 μg a

. i

. /L

Acute

RQ Probability

of Acute

Effect 1

(1 in ...) Chronic RQ

Apples NC apple Airblast 38.0 0.21 7.10 X 10 5 17.3 0.25

OR apple Airblast 12.8 0.07 7.10 X 10 5 6.03 0.09

PA apple Airblast 32.8 0.18 7.10 X 10 5 13.2 0.19

B rassica (Cole) Leafy Vegetables , plus Turnip Greens CA cole

crops Soil drench

after transplant 11.6 0.06 7.10 X 10 5 6.20 0.09

FL cabbage Soil drench

after transplant 4.44 0.02 7.10 X 10 5 1.69 0.02

FL cabbage Soil incorporp.

(15 cm) 1.54 0.01 7.10 X 10 5 0.610 0.01

Bushberry OR

berries Ground 5.73 0.03 7.10 X 10 5 2.92 0.04

Carrots CA row

crops Ground 4.14 0.02 7.10 X 10 5 1.73 0.03

FL

carrots Ground 15.4 0.09 7.10 X 10 5 5.75 0.08

Ginseng MN

sugar beet Ground 5.04 0.03 7.10 X 10 5 2.28 0.03

Lettuce CA

lettuce Ground 1.65 0.01 7.10 X 10 5 0.667 0.01

*Edible

- Podded Legume Vegetables

, except peas; *Succulent Bean; *Dry

Bean , except Peas and Soybeans MI beans Ground 3.60 0.02 7.10 X 10 5 1.77 0.03

OR snap

beans Ground 1.49 0.01 7.10 X 10 5 0.827 0.01

Bulb Vegetables CA onion Ground 1.16 0.01 7.10 X 10 5 0.886 0.01

GA onion Ground 14.7 0.08 7.10 X 10 5 6.11 0.09

Cucurbit Vegetables,

Melon MI

melons Foliar 19.1 0.11 7.10 X 10 5 8.22 0.12

MO

melons Foliar 40.2 0.22 7.10 X 10 5 16.7 0.25

NJ Foliar 41.4 0.23 7.10 X 10 5 17.7 0.26- Page 64 of 137

- Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

EC 50 = 180 μg a

. i

. /L 21

- day

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

NOAEC = 68 μg a

. i

. /L

Acute

RQ Probability

of Acute

Effect 1

(1 in ...) Chronic RQ

melons

Fruiting Vegetable,

Pepper/ Eggplant CA

tomato Foliar 3.73 0.02 7.10 X 10 5 2.20 0.03

FL

peppers Foliar 31.0 0.17 7.10 X 10 5 14.6 0.21

PA

tomato Foliar 33.4 0.19 7.10 X 10 5 15.0 0.22

Peanut NC

peanut Ground 9.70 0.05 7.10 X 10 5 4.75 0.07

Potato ID potato Aerial 1.64 0.01 7.10 X 10 5 1.13 0.02

ME
potato Aerial 3.01 0.02 7.10 X 10 5 1.66 0.02

Soybeans MS soybeans Aerial 6.88 0.04 7.10 X 10 5 3.02 0.04

Turf grasses on golf

courses FL turf Ground 5.98 0.03 7.10 X 10 5 2.18 0.03

PA turf Ground 7.73 0.04 7.10 X 10 5 3.83 0.06

App. = Application

Bolded and shaded values indicate an exceedance of an LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

3 Slope from most sensitive acute freshwater invertebrate toxicity study was 3.6.



### Acute risk to estuarine/marine fish is based on 1 in 10 year peak EECs in the standard pond and the lowest acute toxicity value for estuarine/marine fish

. Chronic risk is based on the 1 in 10 year 60

- day EECs and the lowest chronic toxicity value for estuarine/marine fish . It is noted that the peak and 60

- day EECs refe r to total toxic residues of fluazinam and 5 degradates of concern based on their estimated toxicity through ECOSAR ( DAPA, AMPA, MAPA, G

- 504, SDS

67200 ) Acute and chronic risk quotients for estuarine/marine fish are shown in Table 4. 3

. Acute RQs ranged f rom 0.0 1

– 0. 35 and chronic RQs ranged from 0.1

– 0. 3 6

. There were 10 of

14 ( 71 %) fluazinam uses that (at least one modeled scenario) exceeded at least one acute risk

LOC. There were no uses of fluazinam that exceeded the chronic LOC for estuarine/marine fish

. The probability of an individual chance of effect was estimated using the default slope of 4.5 as a slope was not available from the most sensitive acute estuarine/marine fish toxicity study.- Page 65 of 137

- 

### Table 4. 3 . Acute RQs for Direct Effects to Estuarine/Marine Fish from Fluazinam TGAI.

Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Estuarine/marine

Fish

EC 50 = 120 μg a

. i

. /L 60

- day

EECs

(μg

a

. i

. /L) Estuarine/marine

Fish

NOAEC = 26 μg a

. i

. /L

Acute

RQ Probability

of Acute

Effect 1

(1 in ...) Chronic RQ

Apples NC apple Airblast 38.0 0.32 4.18 X 10 8 9.31 0.36

OR apple Airblast 12.8 0.11 4.18 X 10 8 4.04 0.16

PA apple Airblast 32.8 0.27 4.18 X 10 8 6.43 0.25

B rassica (Cole) Leafy Vegetables , plus Turnip Greens CA cole

crops Soil drench

after transplant 11.6 0.10 4.18 X 10 8 3.96 0.15

FL cabbage Soil drench

after transplant 4.44 0.04 4.18 X 10 8 0.759 0.03

FL cabbage Soil incorporp.

(15 cm) 1.54 0.01 4.18 X 10 8 0.327 0.01

Bushberry OR

berries Ground 5.73 0.05 4.18 X 10 8 1.74 0.07

Carrots CA row

crops Ground 4.14 0.03 4.18 X 10 8 1.30 0.05

FL

carrots Ground 15.4 0.13 4.18 X 10 8 3.36 0.13

Ginseng MN

sugar beet Ground 5.04 0.04 4.18 X 10 8 1.27 0.05

Lettuce CA

lettuce Ground 1.65 0.01 4.18 X 10 8 0.314 0.01

* Edible

- Podded Legume Vegetables,

except peas;
*Succulent Bean ; *Dry Bean Crop

, except Peas and Soybeans MI beans Ground 3.60 0.03 4.18 X 10 8 1.05 0.04

OR snap

beans Ground 1.49 0.01 4.18 X 10 8 0.567 0.02

Bulb Vegetables CA onion Ground 1.16 0.01 4.18 X 10 8 0.652 0.03

GA

onion Ground 14.7 0.12 4.18 X 10 8 4.69 0.18

Cucurbit Vegetables,

Melon MI

melons Foliar 19.1 0.16 4.18 X 10 8 4.45 0.17

MO

melons Foliar 40.2 0.34 4.18 X 10 8 8.79 0.34

NJ

melons Foliar 41.4 0.35 4.18 X 10 8 7.89 0.30

Fruiting Vegetable,

Pepper/ Eggplant CA

tomato Foliar 3.73 0.03 4.18 X 10 8 1.30 0.05

FL

peppers Foliar 31.0 0.26 4.18 X 10 8 7.11 0.27- Page 66 of 137

- Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Estuarine/marine

Fish

EC 50 = 120 μg a

. i

. /L 60

- day

EECs

(μg

a

. i

. /L) Estuarine/marine

Fish

NOAEC = 26 μg a

. i

. /L

Acute

RQ Probability

of Acute

Effect 1

(1 in ...) Chronic RQ

PA

tomato Foliar 33.4 0.28 4.18 X 10 8 8.85 0.34

Peanut NC

peanut Ground 9.70 0.08 4.18 X 10 8 2.57 0.10

Potato ID potato Aerial 1.64 0.01 4.18 X 10 8 0.910 0.04

ME
potato Aerial 3.01 0.03 4.18 X 10 8 1.15 0.04

Soybeans MS soybeans Aerial 6.88 0.06 4.18 X 10 8 2.10 0.08

Turf grasses on golf

courses FL turf Ground 5.98 0.05 4.18 X 10 8 1.16 0.04

PA turf Ground 7.73 0.06 4.18 X 10 8 1.83 0.07

App. = Application

Bolded and shaded values indicate an exceedance of an LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

2 Slope was not available from most sensitive acute estuarine/marine fish toxicity study and therefore default slope of
4.5 was employed for probably of acute effect estimates



### .

Acute risk to estuarine/marine fish is based on 1 in 10 year peak EECs in the standard pond and the lowest acute toxicity value for estuarine/mari ne invertebrates

. Chronic risk is based on the 1 in 10 year 21

- day EECs and the lowest chronic toxicity value for estuarine/marine invertebrates

. It is noted that the peak and 21

- day EECs refer to total toxic residues (TTR) of fluazinam and 5 degradates of concern based on their estimated toxicity through ECOSAR ( DAPA, AMPA, MAPA, G

- 504, SDS

- 67200 ) Acute and chronic risk quotients for estuarine/marine invertebrates

are shown in Table 4. 4 . Acute RQs ranged from 0 .25

– 8.81 and chronic RQs ranged from 0.3 1

– 8.85

. One hundred percent (100%) of the fluazinam uses that (at least one modeled scenario)

exceeded at least one acute risk LOC . There were 11 of 14 (79%) uses of fluazinam that

exceeded the chronic LOC for estuarine/marine invertebrates . The prob ability of an individual chance of effect was estimated using the default slope of 4.5 as a slope was not available from

the most sensitive acute estuarine/marine inver t ebrate toxicity study.

Table 4.4. Acute RQs for Direct Effects to Estuarine/Marine Invertebrates from

Fluazinam TGAI. 1 ,2

Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 4.7 μg ai/L 21

- day

EECs

(μg ai/L) Estuarine/marine

Invertebrates

NOAEC = 2 μg ai/L

Acute

RQ Probability

of Acute

Effect (1 in ...) 3 Chronic RQ

Apples NC apple Airblast 38.0 8.09 4.18 X 10 8 17.3 8.65- Page 67 of 137

- Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 4.7 μg ai/L 21

- day

EECs

(μg ai/L) Estuarine/marine

Invertebrates

NOAEC = 2 μg ai/L

Acute

RQ Probability

of Acute

Effect (1 in ...) 3 Chronic RQ

OR apple Airblast 12.8 2.72 4.18 X 10 8 6.03 3.02

PA apple Airblast 32.8 6.98 4.18 X 10 8 13.2 6.60

B rassica (Cole) Leafy Vegetables

, plus Turnip Greens CA cole

crops Soil drench

after transplant 11.6 2.47 4.18 X 10 8 6.20 3.10

FL cabbage Soil drench

after transplant 4.44 0.94 4.18 X 10 8 1.69 0.85

FL cabbage Soil incorporp.

(15 cm) 1.54 0.33 4.18 X 10 8 0.610 0.31

Bushberr y OR

berries Ground 5.73 1.22 4.18 X 10 8 2.92 1.46

Carrots CA row

crops Ground 4.14 0.88 4.18 X 10 8 1.73 0.87

FL

carrots Ground 15.4 3.28 4.18 X 10 8 5.75 2.88

Ginseng MN

sugar beet Ground 5.04 1.07 4.18 X 10 8 2.28 1.14

Lettuce CA

lettuce Ground 1.65 0.35 4.18 X 10 8 0.667 0.33

*Edible

- Podd ed Legume Vegetables

, except pea s; *Succulent Bean; *Dry Bean , except Peas and Soybeans MI beans Ground 3.60 0.77 4.18 X 10 8 1.77 0.89

OR snap

beans Ground 1.49 0.32 4.18 X 10 8 0.827 0.41

Bulb Vegetables CA onion Ground 1.16 0.25 4.18 X 10 8 0.886 0.44

GA

onion Ground 14.7 3.13 4.18 X 10 8 6.11 3.06

Cucurbit Vegetables,

Melon MI

melons Foliar 19.1 4.06 4.18 X 10 8 8.22 4.11

MO

melons Foliar 40.2 8.55 4.18 X 10 8 16.7 8.35

NJ

melons Foliar 41.4 8.81 4.18 X 10 8 17.7 8.85

Fruiting Vegetable,

Pepper/ Eggplant CA

tomato Foliar 3.73 0.79 4.18 X 10 8 2.20 1.10

FL

peppers Foliar 31.0 6.60 4.18 X 10 8 14.6 7.30

PA

tomato Foliar 33.4 7.11 4.18 X 10 8 15.0 7.50

Peanut NC

peanut Ground 9.70 2.06 4.18 X 10 8 4.75 2.38- Page 68 of 137

- Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 4.7 μg ai/L 21

- day

EECs

(μg ai/L) Estuarine/marine

Invertebrates

NOAEC = 2 μg ai/L

Acute

RQ Probability

of Acute

Effect (1 in ...) 3 Chronic RQ

Potato ID potato Aerial 1.64 0.35 4.18 X 10 8 1.13 0.57

ME
potato Aerial 3.01 0.64 4.18 X 10 8 1.66 0.83

Soybeans MS soybeans Aerial 6.88 1.46 4.18 X 10 8 3.02 1.51

Turf grasses on golf

courses FL turf Ground 5.98 1.27 4.18 X 10 8 2.18 1.09

PA turf Ground 7.73 1.64 4.18 X 10 8 3.83 1.92

App. = Application

1 Bolded and shaded values indicate an exceedance of an LOC

2 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

3 Slope was not available from most sensitive acute estuarine/marine invertebrate toxicity study and therefore default slope of 4.5 was employed for probably of acute effect estimates.



### Risk to aquatic non

- vascular plants is based on 1 in 10 year peak EECs in the standard pond and

the lowest EC 50 

### value and NOAEC value

. Listed species RQs are derived from a compar i son of the peak EEC to t he most sensitive NOAEC and non lis t ed RQs are derived from a comparison of the peak EEC to the most sen s it i ve EC 50 

### value available. There were no data available for aquatic vascular pl ants and therefore risk cannot be estimated. It is noted that the peak EECs refer to total toxic residues (TTR) of fluazinam and 5 degradates of concern based on their estimated toxicity through ECOSAR ( DAPA, AMPA, MAPA, G

- 504, SDS

- 67200) Listed

spe c ies RQs ranged from 2.37

– 84.49 and non

- listed RQs ranged from 1.05

– 37.64 (Table 4.5)

. One hundred percent (100%) of the fluazinam uses that (at least one modeled scenario) exceeded

the listed and non

- listed species LOCs for aquatic plants.

Table 4.5

. RQ Values for Direct Effects to Aquatic Nonvascular Plants from Fluazinam

TGAI. 1 ,2

Use (s) Scenario Application

Method Peak EECs (μg ai /L) Aquatic Nonvascular Plants

E C 50 = 1.1 μg ai /L

NOAEL = 0.49 μg ai /L

Listed RQs 3 Nonlisted RQs 4

Apples NC apple Airblast 38.0 77.55 34.55

OR apple Airblast 12.8 26.12 11.64

PA apple Airblast 32.8 66.94 29.82

Brassica (Co le) Leafy Vegetables

, plus Turnip Greens CA cole crops Soil drench after transplant 11.6 23.67 10.55

FL cabbage Soil drench after transplant 4.44 9.06 4.04

FL cabbage Soil incorporp. (15 cm) 1.54 3.14 1.40

Bushberry OR berries Ground 5.73 11.69 5.21- Page 69 of 137

- Use (s) Scenario Application

Method Peak EECs (μg ai /L) Aquatic Nonvascular Plants

E C 50 = 1.1 μg ai /L

NOAEL = 0.49 μg ai /L

Listed RQs 3 Nonlisted RQs 4

Carrots CA row crops Ground 4.14 8.45 3.76

FL carrots Ground 15.4 31.43 14.00

Ginseng MN sugar beet Ground 5.04 10.29 4.58

Lettuce CA lettuce Ground 1.65 3.37 1.50

*Ed ible

- Podded Legume Vegetables

,

exce pt peas; *Succulent Bean; *Dry Bean , except Peas and Soybeans MI beans Ground 3.60 7.35 3.27

OR snap beans Ground 1.49 3.04 1.35

Bulb Vegetables CA onion Ground 1.16 2.37 1.05

GA onion Ground 14.7 30.00 13.36

Cucurbit Vegetables,

Melon MI melons Foliar 19.1 38.98 17.36

MO melons Foliar 40.2 82.04 36.55

NJ melons Foliar 41.4 84.49 37.64

Fruiting Vegetable,

Pepper/ Eggplant CA tomato Foliar 3.73 7.61 3.39

FL peppers Foliar 31.0 63.27 28.18

PA tomato Foliar 33.4 68.16 30.36

Peanut NC peanut Ground 9.70 19.80 8.82

Potato ID potato Aerial 1.64 3.35 1.49

ME potato Aerial 3.01 6.14 2.74

Soybeans MS soybeans Aerial 6.88 14.04 6.25

Turf grasses on golf

courses FL turf Ground 5.98 12.20 5.44

PA turf Ground 7.73 15.78 7.03

1 Bolded and shaded values indicate an exceedance of an LOC.

2 Listed aquatic plant LOC = 1; Non

- listed aquatic plant LOC = 1

3 Estimated by dividing the peak EEC by the most sensitive NOAEC

4 Estimated by dividing the peak EEC by the most sensitive EC 50



### 4.1.2. RQ Values for Sediment

- Dwelling Organisms

Acute risk to freshwater benthic invertebrates is based on 1

- in

- 10 year peak pore water EECs in the standard pond and the lowest acute toxicity value for freshwater water column invertebrates

. Chronic risk is based on 1

- in

- 10 year 21

- day EECs and the lowest chronic toxicity value for freshwater benthic invertebrates (sediment and pore water expressed toxicity endpoints). It is noted that the peak and 21

- day EECs refer to total toxic residues o f fluazinam and 5 degradates of concern based on their estimated toxicity through ECOSAR ( DAPA, AMPA, MAPA, G

- 504,

SDS

- 67200)

.

Acute risk quotients for freshwater benthic invertebrates ranged from <0.01

– 0.05 (Tabl e 4.6)

.- Page 70 of 137

- 

### One use (fruiting vegetable) of fluazinam met the acute endangered species LOC of 0.05. Chronic RQs for benthic invert e brates based off of toxicity values expressed in terms of

sedimen t concentratio n ranged from 0.1

– 4.09 and chronic RQs for b en thic invertebrates based of toxicity values exp ressed in terms of pore water concentrations ranged from 0.1

– 3.96 . There

were 6 of 14 ( 43 %) uses of fluazinam that exceeded the chronic LOC for RQs expressed both in terms of sediment toxicity and pore water toxicity.

Table 4. 6. Acute RQ and Chronic RQs for Direct Effects to Freshwater Sediment

- Dwelling

Invertebrates from Fluazinam TGAI. 5

U se(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs (μg ai/L) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4

Apples NC apple Airblast 6.15 0.03 11900 6.05 2.98 2.88

OR apple Airblast 2.92 0.02 5510 2.80 1.38 1.33

PA apple Airblast 5.27 0.03 10210 5.19 2.55 2.47

Bra ssica (Cole) Leafy Vegetables

, plus Turnip

Greens CA cole

crops Soil drench

after transplant 2.63 0.01 5100 2.59 1.28 1.23

FL cabbage Soil drench

after transplant 0.552 <0.01 990 0.503 0.25 0.24

FL cabbage Soil incorporp.

(15 cm) 0.214 <0.01 411 0.209 0.10 0.10

Bushberry OR

berries Ground 1.38 0.01 2600 1.32 0.65 0.63

Carrots CA row

crops Ground 0.852 <0.01 1650 0.840 0.41 0.40

FL

carrots Ground 2.62 0.01 5060 2.57 1.27 1.22

Ginseng MN

sugar beet Ground 0.850 <0.01 1610 0.819 0.40 0.39

Lettuce CA

lettuce Ground 0.227 <0.01 439 0.223 0.11 0.11

*Edible

- Podded

Le gume Vegetables,

except peas; *Succulent Bean; *Dry Bean , except
Peas and Soybeans MI beans Ground 0.762 <0.01 1470 0.746 0.37 0.36

OR snap

beans Ground 0.453 <0.01 872 0.443 0.22 0.21- Page 71 of 137

- U se(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs (μg ai/L) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4

Bulb Vegetables CA

onion Ground 0.416 <0.01 791 0.402 0.20 0.19

GA

onion Ground 3.12 0.02 6040 3.07 1.51 1.46

Cucurbit Vegetables,

Melon MI

melons Foliar 2.81 0.02 5410 2.75 1.35 1.31

MO

melons Foliar 5.44 0.03 10510 5.34 2.63 2.54

NJ

melons Foliar 4.99 0.03 9620 4.89 2.41 2.33

Fruiting Vegetable, Pepper/ Eggplant CA

tomato Foliar 0.841 <0.01 1620 0.823 0.41 0.39

FL

peppers Foliar 4.80 0.03 8860 4.50 2.22 2.14

PA

tomato Foliar 8.51 0.05 16350 8.31 4.09 3.96

Peanut NC

peanut Ground 2.00 0.01 3860 1.96 0.97 0.93

Potato ID potato Aerial 0.570 <0.01 1120 0.567 0.28 0.27

ME
potato Aerial 1.02 0.01 1950 0.993 0.49 0.47

Soybeans MS soybeans Aerial 1.60 0.01 3090 1.57 0.77 0.75

Turf grasses on

golf courses FL turf Ground 0.782 <0.01 1500 0.763 0.38 0.36

PA turf Ground 1.19 0.01 2300 1.17 0.58 0.56

1 Bolded and shaded values indicate an exceedance of an LOC.

2 Based on peak pore water EEC divided by 180 ug a.i/L ( E C 50 value of most sensitive fresh water water column

invertebrate )

3 Based on 21

- day organic carbon (OC)

- normalized sediment EECs divided by OC

- normalized NOAEC of Hyalella

azteca (MRID 48571414) of 4000 μg a.i/kg sediment.

4 Based on 21

- day pore water EECs divided by pore water NOAEC of Hyalella azteca (MRID 48571414) of 2.1 μg

a.i/L.

5 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1



### Table 4.7 summarizes the acute and chronic (pore water only) R Q s for estuarine/mar i ne sediment

- dwell i ng organisms. In the absence of sub

- chronic and chronic estuarine/marine

benthic invertebrates studies , the chronic pore water RQs are derived by the PRZM/EXAMS 21

- day average pore water EECs compared to the NOAEC of the most sensitive water column estuarine/marine NOAEC (mysid shrimp). Acute RQs are derived in the same manner as for freshwater in that pe ak pore water EECs are compared to the most sensitive water column invertebrate (eastern oyster).- Page 72 of 137

- 

### Acute RQs exceeded at least one acute LOC for all registered uses of fluazinam for

estuarine/marine sediment

- dwelling invertebrates (RQs ranged from 0.05

– 1.81 ). For chronic (pore water) risk, the LOC was exceeded for 6 of 14 (43%) registered uses of fluazinam (RQs ranged from 0.10

– 4.16 ) . Chronic sediment

- based RQs were not estimated due to the absence of estuarine/marine sediment toxicity studies.

T able 4. 7 . Acute RQ and Chronic RQs for Direct Effects to Estuarine/Marine Sediment

Dwelling Invertebrates from Fluazinam TGAI. 4

Use(s) Scenario App. Method Acute Chronic

Peak Pore

Water

EECs (μg ai/L) Acute RQ 2 21

- day

pore
water
EECs (μg ai/L) Chronic RQ (pore water) 3

Apples NC apple Airblast 6.15 1.31 6.05 3.03

OR apple Airblast 2.92 0.62 2.80 1.40

PA apple Airblast 5.27 1.12 5.19 2.60

Brassica (Cole) Leafy Vegetables, plus Turnip Greens CA cole

crops Soil drench

after transplant 2.63 0.56 2.59 1.30

FL cabbage Soil drench

after transplant 0.552 0.12 0.503 0.25

FL cabbage Soil incorporp. (15 cm) 0.214 0.05 0.209 0.10

Bushberry OR

berries Ground 1.38 0.29 1.32 0.66

Carrots CA row

crops Ground 0.852 0.18 0.840 0.42

FL carrots Ground 2.62 0.56 2.57 1.29

Ginseng MN sugar

beet Ground 0.850 0.18 0.819 0.41

Lettuce CA

lettuce Ground 0.227 0.05 0.223 0.11

*Edible

- Podded Legume Vegetables, except peas; *Succulent Bean; *Dry Bean,

except Peas and Soybeans MI beans Ground 0.762 0.16 0.746 0.37

OR snap

beans Ground 0.453 0.10 0.443 0.22

Bulb Vegetables CA onion Ground 0.416 0.09 0.402 0.20

GA onion Ground 3.12 0.66 3.07 1.54

Cucurbit Vegetables, Melon MI

melons Foliar 2.81 0.60 2.75 1.38

MO

melons Foliar 5.44 1.16 5.34 2.67- Page 73 of 137

- Use(s) Scenario App. Method Acute Chronic

Peak Pore

Water

EECs (μg ai/L) Acute RQ 2 21

- day

pore
water
EECs (μg ai/L) Chronic RQ (pore water) 3

NJ melons Foliar 4.99 1.06 4.89 2.45

Fruiting Vegetable, Pepper/ Eggplant CA

tomato Foliar 0.841 0.18 0.823 0.41

FL

peppers Foliar 4.80 1.02 4.50 2.25

PA

tomato Foliar 8.51 1.81 8.31 4.16

Peanut NC

peanut Ground 2.00 0.43 1.96 0.98

Potato ID potato Aerial 0.570 0.12 0.567 0.28

ME potato Aerial 1.02 0.22 0.993 0.50

Soybeans MS soybeans Aerial 1.60 0.34 1.57 0.79

Turf grasses on golf courses FL turf Ground 0.782 0.17 0.763 0.38

PA turf Ground 1.19 0.25 1.17 0.59

1 Bolded and shaded values indicate an exceedance of an LOC.

2 Based on peak pore water EEC divided by 4.7 ug a.i/L (EC 50 value of most sensitive estuarine/marine water column invertebrate)

3 Based on 21

- day pore water EECs divided by NOAEC of mysid shrimp of 2 .0 μg a.i/L.

4 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1



### 4.1. 3

. RQ Values for Terrestrial Organisms

As previously discussed in Section 3.2.3 potential direct effects to terrestrial species are based on foliar, airblast, ground spray, and aerial spray applications of fluazinam . Potential risks to birds and, thus, terrestrial

- phase amphibians are evaluated using T

- REX, acute and chronic toxicity data for the most sensitive bird species for which data are available, and the most sensitive dietary item and size class for that species. For terrestrial

- phase amphibians, the most sensitive RQ in T

- REX is for the small bird consuming small insects. For birds the most sensitive RQ in

T

- REX is for the small bird consuming short grass

. The specific EECs for each species are for the same size birds and same dietary items as those considered for acute exposure. Chronic effects are estimated using the lowest available NOAEC from a chronic study for birds

, amphibians, and reptiles . Dietary

- based EECs are divided by toxicity values to estimate chronic dietary

- based RQs.

The acute dietary

- based RQs for birds, reptiles and terrestrial

- phase and amphibians derived using T

- REX are shown in Table 4.10

. There w ere no uses of fluazinam that resulted in the exceedance of any acute LOC for any food item exposure. The RQs in Table 4.10 are expressed as being “less than,” values due to the fact that they are based on a non

- definitive “greater than,”- Page 74 of 137

- 

### LC 50 

### estimate. While there is uncertainty in estimating risk from a non

- definitive endpoint, even these unbounded RQs can be thought of as a “worst case,” scenario of risk as they represent what the RQ would be at most. Chronic dietary

- based RQs are tabulated in Table 4.11. All but one use (legume vegetables ) exceeded the chronic LOC of 1 for at least one food item exposed to

fluazinam

.

Table 4.10. Acute Dietary

- Based RQs for Birds, Reptiles, and Terrestrial

- phase Amphibians of Different Feeding Classes (T

- REX v. 1 .5 .1 ). 1,2

Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short Grass Tall Grass Broad

- leaf

Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

Apple < 0.06 < 0.03 < 0.03 <0.01 < 0.02

Brassica (Cole) Leafy Vegetables , plus Turnip Greens < 0.05 < 0.02 < 0.03 <0.01 < 0.02

Bushberry < 0.06 < 0.03 < 0.04 <0.01 < 0.03

Carrots < 0.04 < 0.02 < 0.02 <0.01 < 0.02

Ginseng < 0.06 < 0.03 < 0.03 <0.01 < 0.02

Lettuce < 0.02 < 0.01 < 0.01 <0.01 < 0.01

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans < 0.02 < 0.01 < 0.01 <0.01 < 0.01

Bulb Vegetables < 0.05 < 0.02 < 0.03 <0.01 < 0.02

Cucurbit Vegetables, Melon < 0.08 < 0.04 < 0.04 <0.01 < 0.03

Fruiting Vegetable, Pepper/ Eggplant < 0.08 < 0.04 < 0.04 <0.01 < 0.03

Peanut < 0.03 < 0.02 < 0.02 <0.01 < 0.01

Potato < 0.03 < 0.01 < 0.02 <0.01 < 0.01

Soybean < 0.02 < 0.01 < 0.01 <0.01 < 0.01

Turf grasses on golf courses < 0.06 < 0.03 < 0.04 <0.01 < 0.02

1 Bolded and shaded cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted birds

2 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5



### Table 4. 1 1 . Chronic Dietary

- Based RQs for Birds , Reptiles, and Terrestrial

- phase Amphibians of Different Feeding Classes (T

- REX v. 1.5 .1 )

. 1

Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short Grass Tall Grass Broad

- leaf

Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

Apple 3.13 1.43 1.76 0.20 1.23- Page 75 of 137

- Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short Grass Tall Grass Broad

- leaf

Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 2.41 1.11 1.36 0.15 0.94

Bushberry 3.41 1.56 1.92 0.21 1.34

Carrots 2.06 0.94 1.16 0.13 0.81

Ginseng 3.09 1.41 1.74 0.19 1.21

Lettuce 1.73 0.79 0.97 0.11 0.68

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 0.96 0.44 0.54 0.06 0.38

Bulb Vegetables 2.73 1.25 1.53 0.17 1.07

Cucurbit Vegetables, Melon 4.09 1.88 2.30 0.26 1.60

Fruiting Vegetable, Pepper/ Eggplant 4.09 1.88 2.30 0.26 1.60

Peanut 1.76 0.81 0.99 0.11 0.69

Potato 1.50 0.69 0.85 0.09 0.59

Soybean 1.14 0.52 0.64 0.07 0.45

Turf grasses on golf courses 3.34 1.53 1.88 0.21 1.31

1 Bolded and shaded cells indicate that the RQ exceeds the LOC for chronic risk to listed and nonlisted birds (LOC = 1).



### The acute dose

- based RQs for birds, reptiles and terrestrial

- phase amphibians derived using T

REX are shown in Table 4.1 2

. One hundred percent (100%) of fluazinam uses resulted in the exceedance of at least one acute LOC for at least one size class of birds consuming fluazinam

contaminated food items

.- Page 76 of 137

- 

### Table 4.1 2 . Acute Dose

- based RQ values for Birds Exposed to Fluazinam (T

- REX v. 1.5.1). 1 ,2,3

Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

Apple 0.56 0.25 0.31 0.03 0.25 0.11 0.14 0.02 0.08 0.04 0.04 <0.01 0.22 0.10 0.03 0.01 <0.01 <0.01
Brassica (Cole) Leafy Vegetables , plus Turnip Greens 0.43 0.20 0.24 0.03 0.19 0.09 0.11 0.01 0.06 0.03 0.03 <0.01 0.17 0.08 0.02 0.01 <0.01 <0.01

Bushberry 0.61 0.28 0.34 0.04 0.27 0.12 0.15 0.02 0.09 0.04 0.05 0.01 0.24 0.11 0.03 0.01 <0.01 <0.01

Carrots 0.36 0.17 0.21 0.02 0.16 0.07 0.09 0.01 0.05 0.02 0.03 <0.01 0.14 0.06 0.02 0.01 <0.01 <0.01

Ginseng 0.55 0.25 0.31 0.03 0.25 0.11 0.14 0.02 0.08 0.04 0.04 <0.01 0.21 0.10 0.03 0.01 <0.01 <0.01

Lettuce 0.17 0.08 0.09 0.01 0.07 0.03 0.04 0.00 0.02 0.01 0.01 <0.01 0.07 0.03 0.01 <0.01 <0.01 <0.01

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean, except Peas and Soybeans 0.17 0.08 0.10 0.01 0.08 0.03 0.04 0.00 0.02 0.01 0.01 <0.01 0.07 0.03 0.01 <0.01 <0.01 <0.01

Bulb Vegetables 0.48 0.22 0.27 0.03 0.22 0.10 0.12 0.01 0.07 0.03 0.04 <0.01 0.19 0.08 0.03 0.01 <0.01 <0.01

Cucurbit Vegetables, Melon 0.73 0.33 0.41 0.05 0.33 0.15 0.18 0.02 0.10 0.05 0.06 0.01 0.28 0.13 0.04 0.01 <0.01 <0.01
Fruiting Vegetable, Pepper/ Eggplant 0.73 0.33 0.41 0.05 0.33 0.15 0.18 0.02 0.10 0.05 0.06 0.01 0.28 0.13 0.04 0.01 <0.01 <0.01

Peanut 0.31 0.14 0.18 0.02 0.14 0.06 0.08 0.01 0.04 0.02 0.02 <0.01 0.12 0.05 0.02 <0.01 <0.01 <0.01

Potato 0.27 0.12 0.15 0.02 0.12 0.05 0.07 0.01 0.04 0.02 0.02 <0.01 0.10 0.05 0.01 <0.01 <0.01 <0.01

Soybean 0.20 0.09 0.11 0.01 0.09 0.04 0.05 0.01 0.03 0.01 0.02 <0.01 0.08 0.04 0.01 <0.01 <0.01 <0.01

Turf grasses on golf courses 0.59 0.27 0.33 0.04 0.27 0.12 0.15 0.02 0.08 0.04 0.05 0.01 0.23 0.10 0.03 0.01 <0.01 <0.01

1 Bolded and shaded cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted birds

2 Using adjusted LD 50 values of 1283, 1634, and 2308 for small , medium, and large birds, respectively.

3 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5- Page 77 of 137

- 

### Potential risks to mammals are evaluated using T

- REX, acute and chronic toxic ity data for laboratory ra t s , and the most sensitive dietary item and size class for that species. For mammals the most sensitive RQ in T

- REX is for the sma ll mammal consuming short grass. The specific EECs for each species are for the same size mammals and same dietary items as those considered for acute exposure. Chronic effects are estimated using the lowest available NOAEC from a chronic study for mamma ls . Dietary

- based EECs are divided by toxicity values to estimate chronic dietary

- based RQs.

The acute dose

- based RQs for mammals are tabulated below in Table 4.13

. There were no uses of fluazinam that resulted in the exceedance of any acute LOC for any food item exposure for

mammals

. Chronic dose

- based RQs are tabulated in Table 4.1 4

. All uses of fluazinam resulted in the exceedance of the chronic LOC for all size classes consuming at least one fluazinam

contaminated food item. Chronic dietary

- bas ed RQs are presented in Table 4.15 . All uses of

fluazinam resulted in th e exceedance of the chronic LOC for mammals consuming at least one

fluazinam

- contaminated food item n a dietary

- basis.- Page 78 of 137

- 

### Table 4.1 3

. Acute Dose

- based RQ values for Mam mals Exposed to Fluazinam (T

- REX v. 1. 5 .1 ) 1 ,2,3

Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 

Apple 0.07 0.03 0.04 <0.01 0.06 0.03 0.03 <0.01 0.03 0.01 0.02 <0.01 0.03 0.02 0.01 <0.01 <0.01 <0.01
Brassica (Cole) Leafy Vegetables , plus Turnip

Greens 0.05 0.02 0.03 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.02 0.01 <0.01 <0.01 <0.01

Bushberry 0.07 0.03 0.04 <0.01 0.06 0.03 0.03 <0.01 0.03 0.02 0.02 <0.01 0.03 0.02 0.01 <0.01 <0.01 <0.01

Carrots 0.04 0.02 0.02 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 <0.01 <0.01

Ginseng 0.07 0.03 0.04 <0.01 0.06 0.03 0.03 <0.01 0.03 0.01 0.02 <0.01 0.03 0.02 0.01 <0.01 <0.01 <0.01

Lettuce 0.02 0.01 0.01 <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 <0.01 <0.01

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean, except Peas and Soybeans 0.02 0.01 0.01 <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 <0.01 <0.01

Bulb Vegetables 0.06 0.03 0.03 <0.01 0.05 0.02 0.03 <0.01 0.03 0.01 0.01 <0.01 0.02 0.02 0.01 <0.01 <0.01 <0.01

Cucurbit Vegetables, Melon 0.09 0.04 0.05 0.01 0.07 0.03 0.04 <0.01 0.04 0.02 0.02 <0.01 0.03 0.03 0.02 <0.01 <0.01 <0.01
Fruiting Vegetable, Pepper/ Eggplant 0.09 0.04 0.05 0.01 0.07 0.03 0.04 <0.01 0.04 0.02 0.02 <0.01 0.03 0.03 0.02 <0.01 <0.01 <0.01

Peanut 0.04 0.02 0.02 <0.01 0.03 0.01 0.02 <0.01 0.02 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 <0.01 <0.01

Potato 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

Soybean 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 0.01 0.01 0.00 <0.01 <0.01 <0.01

Turf grasses on golf courses 0.07 0.03 0.04 <0.01 0.06 0.03 0.03 <0.01 0.03 0.01 0.02 <0.01 0.03 0.02 0.01 <0.01 <0.01 <0.01

1 Bolded and shaded cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted mammals

2 Using adjusted LD 50 values of 9011

, 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- Page 79 of 137

- 

### Table 4.1 4

. Chronic Dose

- based RQ Values for Mammals Exposed to Fluazinam (T

- REX v.1. 5 .1 ). 1,2,3

Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivore s Animal Size  Sm Med L g Sm Med L g Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains,

etc

. Use(s) 

Apple 25.61 11.74 14.40 1.60 21.87 10.03 12.30 1.37 11.73 5.37 6.60 0.73 10.03 8.57 4.59 0.36 0.30 0.16
Brassica (Cole) Leafy Vegetables , plus Turnip

Greens 19.74 9.05 11.10 1.23 16.86 7.73 9.49 1.05 9.04 4.14 5.08 0.56 7.73 6.60 3.54 0.27 0.23 0.13

Bushberry 27.94 12.80 15.71 1.75 23.86 10.94 13.42 1.49 12.79 5.86 7.20 0.80 10.94 9.35 5.01 0.39 0.33 0.18

Carrots 16.83 7.71 9.46 1.05 14.37 6.59 8.08 0.90 7.70 3.53 4.33 0.48 6.59 5.63 3.02 0.23 0.20 0.11
Ginseng 25.26 11.58 14.21 1.58 21.57 9.89 12.13 1.35 11.56 5.30 6.50 0.72 9.89 8.45 4.53 0.35 0.30 0.16

Lettuce 7.68 3.52 4.32 0.48 6.56 3.01 3.69 0.41 3.52 1.61 1.98 0.22 3.01 2.57 1.38 0.11 0.09 0.05

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean, except Peas and Soybeans 7.85 3.60 4.41 0.49 6.70 3.07 3.77 0.42 3.59 1.65 2.02 0.22 3.07 2.63 1.41 0.11 0.09 0.05

Bulb Vegetables 22.32 10.23 12.56 1.40 19.07 8.74 10.73 1.19 10.22 4.68 5.75 0.64 8.74 7.47 4.00 0.31 0.26 0.14
Cucurbit Vegetables, Melon 33.51 15.36 18.85 2.09 28.62 13.12 16.10 1.79 15.34 7.03 8.63 0.96 13.12 11.21 6.01 0.47 0.40 0.21 Fruiting Vegetable, Pepper/ Eggplant 33.51 15.36 18.85 2.09 28.62 13.12 16.10 1.79 15.34 7.03 8.63 0.96 13.12 11.21 6.01 0.47 0.40 0.21

Peanut 14.40 6.60 8.10 0.90 12.30 5.64 6.92 0.77 6.60 3.02 3.71 0.41 5.64 4.82 2.58 0.20 0.17 0.09

Potato 12.30 5.64 6.92 0.77 10.51 4.82 5.91 0.66 5.63 2.58 3.17 0.35 4.82 4.11 2.21 0.17 0.15 0.08
Soybean 9.32 4.27 5.24 0.58 7.96 3.65 4.48 0.50 4.27 1.95 2.40 0.27 3.65 3.12 1.67 0.13 0.11 0.06
Turf grasses on golf courses 27.37 12.55 15.40 1.71 23.38 10.72 13.15 1.46 12.53 5.74 7.05 0.78 10.72 9.16 4.91 0.38 0.32 0.17

1 Bolded and shaded cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted mammals

. 2 Using adjusted NOAEL values of 23.30

, 18.85 , and 8.15 for small , medium, and large mammals, respectively.

3 Chronic risk LOC = 1.- Page 80 of 137

- 

### Table 4.1 5

. Chronic Dietary

- Based RQs for Mammals of Exposed to Fluazinam (T

- REX v.1.5.1). 1,2

Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short

Grass Tall

Grass Broad

leaf

Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

Apple 6.26 2.87 3.52 0.39 2.45

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 4.82 2.21 2.71 0.30 1.89

Bushberry 6.83 3.13 3.84 0.43 2.67

Carrots 4.11 1.88 2.31 0.26 1.61

Ginseng 6.17 2.83 3.47 0.39 2.42

Lettuce 1.88 0.86 1.06 0.12 0.74

*Edible

- Podded Legume Vegetables , except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 1.92 0.88 1.08 0.12 0.75

Bulb Vegetables 5.45 2.50 3.07 0.34 2.14

Cucurbit Vegetables, Melon 8.19 3.75 4.61 0.51 3.21

Fruiting Vegetable, Pepper/ Eggplant 8.19 3.75 4.61 0.51 3.21

Peanut 3.52 1.61 1.98 0.22 1.38

Potato 3.01 1.38 1.69 0.19 1.18

Soybean 2.28 1.04 1.28 0.14 0.89

Turf grasses on golf courses 6.69 3.07 3.76 0.42 2.62

1 Bolded and shaded cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted mammals.

2 Chronic risk LOC = 1



### Risk to terrestrial plants in dry areas and semi

- aquatic areas resulting from runoff and spray drift

of fluazinam was estimated usi ng the TerrPlant (v.1.2.2) model. The TerrPlant derived EECs are compared to the most sensitive monocot and dicot EC 25 

### to generate a non

- listed species RQ and compared to the most sensitive NOAEC or EC 05 

### to generate a listed species RQ. The listed and

n on

- listed terrestrial plant LOC is 1. The available seedling emergence study did not definitively

achieve a NOAEC or EC 05 

### for both a monocot and dicot species and therefore risk could not be estimated for listed species in both dry and semi

- aquatic areas resulting from spray drift and runoff. The RQs for nontarget monocot and dicot species are tabulated below in Tables 4.16

and 4.17 , respectively. For nonlisted species and for listed species risk resulting from spray drift only, there wer e no LOC exceedances to both monocots and dicots resulting from the use of

fluazinam.- Page 81 of 137

- 

### Table 4.16 . RQs for Nontarget Monocots Adjacent to Fluazinam Use Areas

.

Crop Single Max. Application

Rate (lbs ai /A) Monocot RQ Values 2

Spray Drift Only Runoff and Spray Drift ( Dry Areas ) Runoff and Spray Drift ( Semi

- Aquatic Areas )

Nonlisted

Species Listed Species Nonlisted Species Listed Species 1 Nonlisted Species Listed Species 1

Apple 0.45 <0.1 <0.1 <0.1 N/D <0.1 N/D

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 1 .36 <0.1 <0.1 <0.1 N/D <0.1 N/D

Bushberry 0.652 <0.1 <0.1 <0.1 N/D <0.1 N/D

Carrots 0.521 <0.1 <0.1 <0.1 N/D <0.1 N/D

Ginseng 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

Lettuce 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

*Edible

- Podded Legume Vegetables ,

except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 0.304 <0.1 <0.1 <0.1 N/D <0.1 N/D

Bulb Vegetables 0.521 <0.1 <0.1 <0.1 N/D <0.1 N/D

Cucurbit Vegetables,

Melon 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

Fruiting Vegetable, Pepper/ Eggplant 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

Peanut 0.70 <0.1 <0.1 <0.1 N/D <0.1 N/D

Potato 0.261 <0.1 <0.1 <0.1 N/D <0.1 N/D

Soybean 0.521 <0.1 <0.1 <0.1 N/D <0.1 N/D

Turf grasses on golf

courses 0.700 <0.1 <0.1 <0.1 N/D < 0.1 N/D

N/D = Not determined

1 NOAEC for monocot and dicot species for seedling emergence study was not determined, therefore risk cannot be

estimated

2 LOC for listed and non

- listed species = 1



### Table 4.1 7 . RQs for Nontarget Dicot Ad jacent to Fluazinam Use Areas

.

Crop Single Max. Application

Rate (lbs ai /A) Dicot RQ Values 2

Spray Drift Only Runoff and Spray Drift ( Dry Areas ) Runoff and Spray Drift ( Semi

- Aquatic Areas )

Nonlisted

Species Listed Species Nonlisted Species Listed Species 1 Nonlisted Species Listed Species 1

Apple 0.45 <0.1 <0.1 <0.1 N/D <0.1 N/D

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 1 .36 <0.1 <0.1 <0.1 N/D <0.1 N/D

Bushberry 0.652 <0.1 <0.1 <0.1 N/D <0.1 N/D- Page 82 of 137

- Crop Single Max. Application

Rate (lbs ai /A) Dicot RQ Values 2

Spray Drift Only Runoff and Spray Drift ( Dry Areas ) Runoff and Spray Drift ( Semi

- Aquatic Areas )

Nonlisted

Species Listed Species Nonlisted Species Listed Species 1 Nonlisted Species Listed Species 1

Carrots 0.521 <0.1 <0.1 <0.1 N/D <0.1 N/D

Ginseng 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

Lettuce 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

*Edible

- Podded Legume Vegetables ,

except peas; *Succulent Bean; *Dry Bean Crop, except Peas and Soybeans 0.304 <0.1 <0.1 <0.1 N/D <0.1 N/D

Bulb Vegetables 0.521 <0.1 <0.1 <0.1 N/D <0.1 N/D

Cucurbit Vegetables,

Melon 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

Fruiting Vegetable, Pepper/ Eggplant 0.782 <0.1 <0.1 <0.1 N/D <0.1 N/D

Peanut 0.70 <0.1 <0.1 <0.1 N/D <0.1 N/D

Potato 0.261 <0.1 <0.1 <0.1 N/D <0.1 N/D

Soybean 0.521 <0.1 <0.1 < 0.1 N/D <0.1 N/D

Turf grasses on golf

courses 0.700 <0.1 <0.1 <0.1 N/D <0.1 N/D

N/D = Not determined

1 NOAEC for monocot and dicot species for seedling emergence study was not determined, therefore risk cannot be

estimated

2 LOC for listed and non

- listed species = 1



### 4.1.4. Bioaccumulation Analysis Results

KABAM was used to calculate risk quotients from a bioaccumulation pathway for food items that may be consumed by birds and mammals ( Table 4.1 8 ). The RQs for bioaccumulation risk

did not exceed any acute or chronic LOC. Acute dietary based risk could not be estimated for

mammals as there were no data available. Similarly , chronic dose

- based risk for birds could not

be estimated.

Table 4.1 8 . Summary of RQ Values f or Mammals and Birds C onsuming F is h

C ontaminated by Fluazinam 1

Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

Mammalian Fog/water shrew <0.01 N/A 0.05 0.01

Rice rat/star nosed

mole <0.01 N/A 0.06 0.01

Small mink <0.01 N/A 0.08 0.01 Large mink <0.01 N/A 0.09 0.01- Page 83 of 137

- Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

Small river otter <0.01 N/A 0.09 0.01 Large river otter <0.01 N/A 0.10 0.01

Avian Sandpipers <0.01 <0.01 N/A 0.01

Cranes <0.01 <0.01 N/A 0.01

Rails <0.01 <0.01 N/A 0.01

Herons <0.01 <0.01 N/A 0.01 Small osprey <0.01 <0.01 N/A 0.01 White pelican <0.01 <0.01 N/A 0.01 N/A = Not applicable

1 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5; chronic risk LOC

=1.



### 4. 2

. Risk Description

4. 2 .1. Risks to Aquatic Organisms

Peak, 21

- day average, and 60

- day average EECs were generated using the total toxic residue approach (TTR) for parent fluazinam as well as the degradates DAPA, AMPA, MAPA, G

- 504,

and SDS

- 67200 which were shown by ECOSAR analysis to have similar toxicity to parent

fluazi nam for at least one taxon (See Section 3.3.3 ).

4.2.1.1. Freshwater Fish and Aquatic

– Phase Amphibians

The results of this screening

- level risk assessment indicate that all registered uses of fluazinam (and the associated residues of 5 degradates of concern) have the potential for direct adverse

effects to listed and non

- listed freshwater fish on both an acute and chronic basis (acute RQs:

0.03

– 1.15 , chronic RQs: 0.46

– 12.74 )

. Although fluazinam has a very low solubility (0.072 mg/L), peak and 60

- day average EECs derived from PRZM/EXAMS indicate that there were no use scenario that exceeded the limit of solubility that resulted in RQs that would exceed acute or

chronic LOCs. The individual chance of an acute effect to freshwater fish was derived using a default slope of 4.5 due to the absence of one in the available data and yielded a probability of 1

in 4.18 X 10 8. 

### Additionally, there were no ecological incidents reported for freshwater fish

result ing from the use of fluazinam. For risk assessment purposes, fresh w ater fish serve as surrogates for aquatic

- phase amphibians.

There is some conservatism in the fact that chronic freshwater fish RQs were derived using the

6 0

- day average EEC compared to a 278

- day chronic fish full life cycle toxicity NOAEC instead

of the 32

- day fish early life stage endpoint. Despite this, if using the 32

- day chronic early life stage NOAEC available for freshwater fish (5.3 μg a.i/L), the chronic LOC of 1 would still be

e xceeded for 3 of 14 uses of fluazinam (apples, cucurbits, fruiting vegetables), while all uses of fluazinam exceed the LOC when using the more sensitive full life cycle endpoint.

Hydrolysis and aerobic aquatic metabolism studies indicate that parent flu azinam is susceptible to degradation to, among others, CAPA. ECOSAR analyses indicate that CAPA is at least 2- Page 84 of 137

- 

### orders of magnitude less toxic to freshwater fish on an acute basis and 3 orders of magnitude less toxic on a chronic exposure basis. Similarly, for freshwater invertebrates, CAPA is 2 orders of magnitude less sensitive than parent fluazinam on an acute basis and chronic basis. Aerobic and anaerobic aquatic metabolism data show that the major transformation products observed are DAPA, SDS

- 67200, AMPA, DCPA, and CAPA. These studies resulted in very short half lives for the parent compound (≤8 hours in one study and 2.8 days and 8.33 days in two other studies that were submitted later), with subsequent formation of the above mentioned degradates. DAPA, AMPA, and SDS

- 67200 show one order of magnitude of decreased toxicity from parent fluazinam to freshwater fish and invertebrates on an acute exposure basis. Similarly, all observed degradates in these studies show at least one order of magnitude les s sensitivity than parent fluazinam for chronic freshwater fish toxicity. Fluazinam is shown to photolyse in aqueous solutions mainly to G

- 504 with a half life of 2.17 days. ECOSAR predicted toxicity of

G

- 504 shows 2 order of magnitude decreased toxicity for freshwater fish and invertebrates on an acute exposure basis. Despite the propensity for fluazinam to degrade in aquatic environments via various pathways, to various degradation products, available information shows that parent

fluazinam is the stre ssor with the highest toxicity to aquatic organisms. Using a conservative approach, EECs were calculated for fluazinam plus five transformation products of ecological concern, using the residue summation (RS) approach.

4.2.1.2. Freshwater Invertebrates

Freshwater invertebrates were shown in toxicity studies to be less sensitive to fluazinam than freshwater fish and the acute RQs reflect this with acute RQs ranging from 0.01

– 0.23 . There were no exceedances of the acute high risk LOC and RQs marginally exceeded the acute endangered species and acute restricted use LOCs for 7 of 14 registered fluazinam uses.

There were no uses of fluazinam where chronic RQs exceeded the LOC for freshwater

invertebrates. The individual chance of an acute effect to fre shwater invertebrates was derived using a study

- calculated slope of 3.6 which yielded a probability of 1 in 7.10 X 10 5



### . Additionally, there were no ecological incidents reported to freshwater invertebrates resulting

from the use of fluazinam.

Refer to th e section above, Section 4.2.1.1

, regarding degradate toxicity to freshwater

invertebrates.

4.2.1.3. Estuarine/Marine Fish

The results of this screening

- level risk assessment indicate that 10 of 14 (71%) of registered uses of fluazinam (and the associa ted residues of 5 degradates of concern) have the potential for direct

adverse effects to listed freshwater invertebrates on an acute basis (acute RQs: 0.0 1

– 0.35 ). There were no exceedances of the acute high risk (non

- listed) species LOC of 0.5 for

estu arine/marine fish. Similarly , there were no registered uses of fluazinam that resulted in the

exceedance of the chronic LOC of 1. The individual chance of an acute effect to estuarine/marine fish was derived using a default slope of 4.5 due to the absen ce of one in the- Page 85 of 137

- 

### available data and yielded a probability of 1 in 4.18 X 10 8. 

### Additionally, there were no ecological incidents reported to estuarine/marine fish resulting from the use of fluazinam.

4.2.1.4. Estuarine/Marine Invertebrates

Estuarine/marine invertebrates were shown in toxicity studies to be more sensitive to fluazinam than estuarine/marine fish and the acute and chronic RQs reflect that with acute RQs ranging

from 0.25

– 8.81 and chronic RQs ranging from 0.33

– 8.85 . All acu te LOCs (acute endangered species, acute restricted use, and acute high risk) were exceeded for all registered uses ( for at least one scenario for a given use ) of fluazinam. For chronic risk, 11 of 14 (79%) of the registered uses of fluazinam exceeded the chronic LOC of 1. The individual chance of an acute

effect to estuarine/marine invertebrates was derived using a default slope of 4.5 due to the

absence of one in the available data which yielded a probability of 1 in 4.18 X 10 8 

### . Additionally,

there wer e no ecological incidents reported to estuarine/marine invertebrates resulting from the

use of fluazinam.

While the same previously mentioned degradates are of concern in the estuarine/marine environment as in freshwater, the ECOSAR estimates of toxicity are more limited than for freshwater taxa. CAPA and DCPA are 2 orders of magnitude less toxic than parent fluazinam to estuarine/marine fish on an acute and chronic exposure basis. There were no other degradates

that had estimates available and ECOSAR do es not predict acute or chronic toxicity to

estuarine/marine invertebrates. In the absence of other toxicity information, it was assumed that

all the metabolites previously identified were equally as toxic as the parent compound. EECs for

the total toxic residues (TTR)

, using the residue summation approach (RS) , and including the transformation products DAPA, AMPA, MAPA, G

- 504 and DSD

- 67200 , were calculated

. Additionally, the following metabolites are excluded: HYPA, CAPA & DCPA due to the previously ment ioned ECOSAR analysis indicated less toxicity than parent fluazinam

.

4.2.1.5. Refinement of Estuarine/Marine Organism Risk

The fluazinam labels impose a buffer zone restriction of 150 ft towards estuarine/marine bodies of water. Furthermore, the minimum spray volume for aerial applications is relatively high (5 gal lons/a cre). However, no wind speed or droplet size restrictions are imposed. To further characterize the spray drift for this buffer zone, the drift model AgDRIFT v.2.11 was used. The default value of spray drift for aerial applications is 5%. This is the value used in modeling aerial applications on potatoes and soybeans. Besides EECs for the aerial application, EFED calculated EECs for ground applications, with the default spray dr ift value of 1%. Findings are

summarized in Table 4.19 below.

As a refinement, the spray drift value for a buffer zone of 150 ft towards estuarine/marine bodies

of water was determined. The label for Omega 500F does not specify any wind speed or droplet size category restrictions; thus, the wind speed is assumed to be 15 mph and the droplet size is

assumed to be fine to medium. These are default parameters used in EFED. On these assumptions and a pplying a spray volume of 5 ga llons/acre ( which is specif ied in the label for Omega 500F ), the spray drift is 4.1%

. T his value is not much smaller than the default spray drift- Page 86 of 137

- 

### of 5%. Thus, EFED explored additional options. Assuming that the label imposes a maximum wind speed of 10 mph, the spray drift value i s reduced to 3.3% . Assuming a wind speed of 10 mph and a medium droplet size distribution (which is the next courser category in AgDRIFT), the spray drift value would be reduced to 2.5% . Given that the specified spray volume is relatively large, a coarse r droplet size distribution , compared to the default of fine to medium, is possible. Furthermore, wind speed restrictions in labels are not uncommon.

Table 4.19

. EECs for the Aerial and Ground Applications of Fluazinam on Potatoes and Soybeans

Scenario (bold font)/ Crops/Uses Represented App

Method * App

Rate (lb a.i./A) Date

of

First Appl (dd

mm) Number of Apps App

Interval (days) Water Column Pore Water

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L) Peak

EEC (μg/L) 21

- day

average

EEC (μg/L)

Potato/ ID potato Aerial

0.261 15

- 05 7 7 1.64 1.13 0.91 0.57 0.5 7

Ground 0.69 0.53 0.47 0.33 0.33

ME potato Aerial 3.01 1.66 1.15 1.02 0.99

Ground 2.65 1.19 0.79 0.71 0.70 Soybeans/

MS soybeans Aerial

0.521 16

- 05 2 10 6.88 3.02 2.10 1.60 1.57

Ground 7.09 3.07 1.97 1.55 1.48

*For aerial applications, assumed drift=5%; for ground applications, spray drift=1%.



### As expected, the EECs for the ground applications are lower than for aerial applications. One exception is MS soybeans, for which the peak and 21

- day EECs are nearly the same. One possible reason for this difference is that the field in MS soybean have a large runoff component

, as compared to spray drift . For aerial applications, the application efficiency is 95% while for ground applications, it is 99%

. If the MS soybean scenario has a large runoff component, the higher application efficiency may cause a higher runoff component and the EECs would reflect

this. For the ID and ME potato scenarios, the decrease s in the peak EECs for the ground applications, relative to the aerial applications, are substantial

.

When compared to the available acute and chr onic toxicity data for estuarine/marine fish , the refined scenarios of exposure resulted in RQs that were very similar to those that were estimated without the use of a buffer zone ( Table 4.20 ). Acute RQs for the ground and aerial soybean use marginally e xceeded the acute endangered species LOC of 0.05 (RQs ranged from 0.01

– 0.06 ). There were no acute RQs exceedances for the potato uses or chronic RQ exceedances for both the potato and soybean uses.- Page 87 of 137

- 

### Table 4 .20

. Acute and Chronic RQ s for Estuari ne/marine Fish Resulting from Aerial and Ground Applications of Fluazinam on Potatoes and Soybeans with Buffer Zone

Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine Fish

EC 50 = 120 μg ai/L 60

- day

EECs (μg ai/L) Estuarine/marine

Fish

NOAEC =

2 6 μg ai/L

Acute

RQ Probability of

Acute Effect 1

(1 in ...) 2 Chronic RQ

Potato ID potato Aerial 1.64 0.01 4.18 X 10 8 0.910 0.04

Ground 0.694 0.01 4.18 X 10 8 0.465 0.02

ME potato Aerial 3.01 0.03 4.18 X 10 8 1.15 0.04

Ground 2.65 0.02 4.18 X 10 8 0.794 0.03

Soybeans MS soybeans Aerial 6.88 0.06 4.18 X 10 8 2.10 0.08

Ground 7.09 0.06 4.18 X 10 8 1.97 0.08

Bolded and shaded values represent LOC exceedances

1 LOC are: acute endangered species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic

LOC = 1



### When compared to the available acute and chronic toxicity data for estuarine/marine invertebrates, the refined scenarios of exposure resulted in RQs that were very similar to those

that were estimated without the use o f a buffer zone ( Table 4.2 1 ). Acute RQs for the ground and aerial potat o use exceeded all acute LOC for the ME potato scenario and the acute endangered species and acute restricted use LOC for ID potato scenario. For the soybean use, acute RQs exceeded all acute risk LOCs (RQs ranged from 0.15

– 1.51 for both potato and soybean uses). There were no chronic LOC exceedances for the potato use (both scenarios) and both ground and

aeri al scenarios exceeded the chronic LOC of 1 for the soybean use. T

Table 4.21

. Acute and Chronic RQ s for Estuarine/marine Invertebrates Resulting from Aerial and Ground Applications of Fluazinam on Potatoes and Soybeans with Buffer

Zone 1 ,2

Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 4.7 μg ai/L 21

- day

EECs

(μg ai/L) Estuarine/marine

Invertebrates

NOAEC = 2 μg ai/L

Acute

RQ Probability of

Acute Effect

(1 in ...) 3 Chronic RQ

Potato ID potato Aerial 1.64 0.35 4.18 X 10 8 1.13 0.57

Ground 0.694 0.15 4.18 X 10 8 0.534 0.27

ME potato Aerial 3.01 0.64 4.18 X 10 8 1.66 0.83

Ground 2.65 0.56 4.18 X 10 8 1.19 0.60

Soybeans MS soybeans Aerial 6.88 1.46 4.18 X 10 8 3.02 1.51

Ground 7.09 1.51 4.18 X 10 8 3.07 1.54

1 Bolded and shaded values represent LOC exceedances

2 LOC are: acute endangered species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic

LOC = 1

3 Slope not available from most sensitive estuarine/marine invertebrate study and therefore default slope of 4.5 was

used.- Page 88 of 137

- 

### Table 4.22 summarizes the acute and chronic (pore water only) risk to estuari n e/marine

sediment

- dwelling invertebrates for ground and aerial uses of fluazinam on potato and soybeans

with the use of a buzzer zone. Acute RQs either exceeded the acute endangered species LOC or the acute restricted use LOC for both the soybean and potato uses by either aerial or ground application. There were no chronic LOC exceedances using the most sensitive water column

NOAEC for e stuarine/marine invertebrates in the absence of estuarine/marine benthic

invertebrate data.

Table 4.22

. Acute and Chronic (pore water) RQ s for Estuarine/marine Sediment

- Dwelling Invertebrates Resulting from Aerial and Ground Applications of Fluazinam on P otatoes and Soybeans with Buffer Zone 1,4

Use(s) Scenario App.

Method Peak Pore

water
EECs (μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 4.7 μg ai/L 21

- day pore water
EECs (μg ai/L) Estuarine/marine

Invertebrates

NOAEC = 2 μg ai/L

Acute RQ 2 Chronic RQ (pore water) 3

Potato ID potato Aerial 0.57 0.12 0.57 0.29

Ground 0.33 0.07 0.33 0.17

ME
potato Aerial 1.02 0.22 0.99 0.50

Ground 0.71 0.15 0.70 0.35

Soybeans MS soybeans Aerial 1.60 0.34 1.57 0.79

Ground 1.55 0.33 1.48 0.74

1 Bolded and shaded values indicate an exceedance of an LOC.

2 Based on peak pore water EEC divided by 4.7 ug a.i/L (EC 50 value of most sensitive estuarine/marine water column invertebrate)

3 Based on 21

- day pore water EECs divided by NOAEC of mysid shrimp of 2.0 μg a.i/L.

4 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1



### 4.2.1.6. Sediment

- dwelling Organisms

Fluazinam is shown to have a moderately high octanol/water partition coefficient (log K OW 

### = 3.56) and a tend e ncy to partition with soils with moderately high K OC 

### s . When taken with the fact that half lives are relatively short in the aquatic media for the parent compound, but moderate in aerobic media and slow in anaerobic media, and the propensity to bind to soils, sediment exposure cannot be discounted. Batch equilibrium studies show parent fluazinam to be slightly mobile ( K OC 

### = 1958 mL/g OC 

### )

. A cute risk to sediment dwelling organisms is derived by a comparison of the peak pore water EECs generated by PRZM/EXAMS to the most sensitive

water column invertebrate E C 50 

### . Chronic risk is expressed both in terms of in the sediment and in the pore water with corresponding EECs and toxicity endpoints used for their estimation. Acute and chronic ( organic

- carbon normalized sediment and porewater) risk was only estimated to freshwater benthic organisms . For estuarine/marine benthic organisms, acute risk was estimated in a similar way (using water column estuarine/marine EC 50 

### data) and chronic risk was only estimated for pore water (using water column NOAEC data) as there were no sediment toxicity studies for estuarine/marine invertebrates with which to estim ate a sediment

- based chronic RQ.- Page 89 of 137

- 

### Freshwater benthic invertebrate a cute RQ s (peak pore water EECs/lowest water column

invertebrate EC 50 

### ) did not exceed any acute risk LOC and met the acute endangered species LOC (RQs ranged from <0.01

– 0.05 ) for one use o nly (fruiting vegetables). Chronic RQs (based on sediment expressed EECs and toxicity endpoints ) exceeded the LOC ( 1 ), for 6 of 14 (43%) of the registered uses of fluazinam (RQs ranged from 0.11

– 4.09 ). Chronic RQs (based on pore water expressed EECs a nd toxicity endpoints) exceeded the chronic LOC (RQs ranged from 0.11

– 3.96 ) also for 6 of 14 (43%) of the registered uses of fluazinam (same uses as with sediment expressed exceedances).

Estuarine/ marine benthic invertebrate acute RQs exceeded at least one acute LOC for all registered uses of fluazinam (RQs ranged from 0.05

– 1.81 ). For chronic (pore water) risk, the LOC was exceeded for 6 of 14 (43%) registered uses of fluazinam (RQs ranged from 0.10

– 4.16 ). Chronic sediment

- based RQs were not estimated due to the absence of estuarine/marine sediment toxicity studies.

While ECOSAR does not have the capability to predict the risk to benthic organisms exposed to the degradates of fluazinam, acute risk would be derived from pore water EECs that are substantially lower than those of the water column and toxicity endpoints (water column freshwater invertebrates) that, as previously mentioned, are at least 2 orders of magnitude less toxic than parent fluaz inam.

4.2.1.7. Aquatic Plants

The results of this screening

- level risk assessment indicates that all registered uses of fluazinam (and the associated residues of 5 degradates of concern) have the potential for direct adverse

effects to listed and non

- listed aquatic non

- vascular plants ( listed species RQs: 2.37

– 84.49

,

non

- listed species RQs : 1.05

– 37 .64 ) . There is some uncertainty in the complete risk picture for aquatic p lants in that there is no suitable data available for estimating risk to vascu lar aquatic plants. Risk can be presumed however as data would need to show an EC 50 

### that is 36 times less

toxic than the most sensitive non

- vascular aquatic p lant study to not exceed the non

- listed species LOC and the NOAEC would have to be 82 times less toxic than the most sensitive non

vascular aquatic plant study to not exceed the listed species LOC.

ECOSAR analyses indicate that CAPA and SDS

- 67200 are one order of magnitude less toxic to freshwater green algae than parent fluazinam. AMPA and DCPA a re 2 orders of magnitude less toxic than parent fluazinam and there are no ECOSAR estimates for G

- 504. DAPA is within an order of magnitude of toxicity as parent fluazinam but is 5 times less toxic than parent.

4. 2 .2. Risks to Terrestrial Organisms

Risk to mammals and birds is estimated with the T

- REX model as discussed previously. The T

REX model assumes a default foliar dissipation half life of 35 days in the absence of available data showing a lower value. Current EFED policy is to use the 35

- da y half life unless there are three values available that when averaged, show a foliar dissipation half life value of less than 35- Page 90 of 137

- 

### days. For fluazinam, there are two studies available that determine the foliar dissipation hal f life on peanuts and potatoes ( MRID 46991302, and 46991303 , respectively ) that show fluazinam to dissipate off foliage at a rate of 7.33 days. There is uncertainty therefore in the resultant acute

and chronic T

- REX derived RQs using the default value of 35 days. Refer to Section 8 of this

assessment for further discussion of this and how risk determinations are affected.

4.2.2.1. Birds , Reptiles, and Terrestrial

- phase Amphibians

Potential risks to birds and, therefore , terrestrial

- phase amphibians and reptiles are evaluated using T

- REX, acute and chronic toxicity data for the most sensitive bird species for which data are available, and the most sensitive dietary item and size class for that species. The results of this screening

- level assessment indicate that acute dose

- based RQs f or birds exceed at last one acute LOC for at least one size class consuming fluazinam contaminated food items for all registered uses. Small birds eating short grass (the modeling scenario with the highest EECs) yielded an exceedance of the acute endanger ed species LOC of 0.1 for all uses and exceedances of the acute high risk (non

- listed species LOC) of 0.5 for 6 of 14 (43%) of the registered fluazinam uses (RQs ranged from <0.01

– 0.73 ). Small birds eating other food items as well as

other size classes of birds eating other fluazinam contaminated food items exceeded the acute endangered species and acute restricted use LOCs, depending on the use, but not the acute high

risk LOC of 0.5.

There were no uses of fluazinam that resulted in the exceedance of any acute LOC for any food item exposure for dietary

- based acute RQs . The RQs in Table 4.10 are expressed as being “less than,” values due to the fact that they are based on a non

- definitive “greater than,” LC 50 

### estimate. While there is uncertainty in estimating risk from a non

- definitive endpoint, even these

unbounded RQs can be thought of as a “worst case,” scenario of risk as they represent what the RQ would be at most.

Chronic dietary

- based RQs for birds e xceeded the LOC of 1 (RQs ranged from 0.06

– 4.09 ) for at least one food item for all but one registered use of fluazinam (legume vegetables). Because of the relative persistence of fluazinam shown in field dissipation studies (half lives ranged from

9 to 49 days) and the relatively high number of application associated with each use of fluazinam, depending on the use, the residues of fluazinam on various food items (especially short grass) is expected to stay above the NOAEC for birds (200 ppm in study wi th northern bobwhite quail) during the time of application and for several weeks after the last application (T

REX simulates exposure out to 105 days). Despite this, chronic risk is expected to be lower for

birds that feed on a wide variety of food items as the EECs associated with food items like fruit, pods, seeds, and arthropods are substantially less than those of short grass. Therefore a bird that exclusively feeds on short grass would be at a greater chronic risk than a bird that feeds on fruits,

po d s, and seeds only.

There is conservatism and some uncertainty with two of the modeled scenarios for fluazinam. For the brassica (cole) leafy vegetables scenario, the labels state that the chemical can either be applied as a soil drench or be applied a nd be soil incorporated at a depth of 6 inches. T

- REX does not have the capability of reliably estimating exposure for either of these scenarios as it- Page 91 of 137

- 

### does not have a soil drench method nor does it allow for a soil incorporation depth as

PRZM/EXAMS does w ith its CAM input. As a result, brassica was modeled at the higher of the two application rates for those scenarios (2.01 lbs a.i/A

– soil drench method) as a foliar spray. The resultant dose and dietary

- based EECs for birds are therefore potentially gre ater than they would be than under an actual soil drench exposure scenario in which the chemical typically does not get exposed to foliage

. It is worth noting that despite these highly conservative EECs for the brassica scenario, there are still other use s of fluazinam with traditional foliar applications that result in higher EECs and therefore RQs.

Additionally, for the carrot scenario, the label stipulates that the application interval is 14 days between the first and second application, and then 7 day s for the interval for each subsequent application. While T

- REX can simulate variable application rates (e.g. 1.5 lbs a.i/A for two applications followed by 1.0 lbs a.i/A for two applications), it does not have the capability to model variable application intervals. As a result, this use was modeled using the more

conservative approach of using the 7 day application interval for all applications. As with the brassica use, despite this conservatism there were other uses of fluazinam that resulted in highe r EEC and therefore RQs, that is, this use did not represent the highest risk for fluazinam to birds.

Using a study

- calculated slope of 5.25, the individual chance of an acute effect (IEC model v.1.0) was run and yielded a probability of 1 in 1.31 X 10 7 

### c hance of effect. Additionally, there are no reported incidents to birds resulting from the use of fluazinam.

4.2.2.2. Mammals

Potential risks to mammals are evaluated using T

- REX, acute and chronic toxicity data for the most sensitive mammal species f or which data are available, and the most sensitive dietary item and size class for that species. The results of this screening

- level assessment indicate that acute

dose

- based RQs for mammals do not exceed any acute LOC for registered uses of fluazinam (R Qs ranged from <0.01

– 0.09 ).

Chronic dose

- based RQs for mammals exceeded the LOC of 1 (RQs ranged from 0.05

– 25.61 )

for at least one food item for all size classes in all registered uses of fluazinam. Chronic RQs exceeded the LOC of 1 for all three size classes modeled for all food items except fruits, pods,

and seeds. Because of the relative persistence of fluazinam shown in field dissipation studies (half lives ranged from 9 to 49 days) and the relatively high number of application associated with each use of fluazinam, depending on the use, the residues of fluazinam on various food items (especially short grass) is expected to stay above the study

- determined NOAEC for

mammals ( 100 ppm in study with the laboratory rat ) during the time of application and for several weeks after the last application (T

- REX simulates exposure out to 105 days). Despite this, chronic risk is expected to be lower f or mammals that feed on a wide variety of food items as the EECs associated with food items like fruit, pods, seeds, and arthropods are substantially less than those of short grass. Therefore a mammal that exclusively feeds on short grass would be at a gr eater chronic risk than a mammal that feeds on fruits, po d s, and seeds only. This is evidenced by the fact that all three size classes of granivores were not at chronic risk when chronic RQs were expressed as dose

- based estimates.- Page 92 of 137

- 

### Chronic dietary

- based R Qs exceeded the LOC of 1 for at least 2 food items for all registered uses

of fluazinam. As was the case in dose

- based chronic risk, there were no exceedances of the LOC for mammals that eat primarily eat fruits , pods, and seeds.

There is some conservat ism with the brassica and carrot scenarios described in Section 4.3.2.1 that also applies to the risk estimates for mammals.

Using a default slope of 4.5 (as one was not available from the acute toxicity study), the IEC model was run to estimate the proba bility of an individual chance of effect. The model yielded a probability of 2.94 X 10 5 

### chance of effect. Additionally, there are no reported incident s to mammals resulting from the use of fluazinam.

4.2.2.3. Terrestrial Invertebrates

Based on the available data for young adult honey bees, technical fluazinam is classified as practically nontoxic to non

- target terrestrial invertebrates on both an acute contact and oral exposure basis. The results of the acute studies show no significant mortality to youn g adult (foraging) bees at any treatment level, with corresponding LD 50 

### values of >100 μg ai /bee for oral exposure and >200 μg a.i/bee for con tact exposure. There is uncertainty though regarding the toxicity of fluazinam to bee larvae since no data on this age group of honey bees were available

at the time of this review. However, no incidents for terrestrial invertebrates associated with the application of fluazinam have been reported.

Additional analysis on using direct effects on the honeybee as a means to predict effects to listed

terrestrial invertebrates is described in Section 6

.

4.2.2.4. Terrestrial Plants

Risk to terrestrial plants in dry areas and semi

- aquatic areas resulting from runoff and spray drift of fluazinam was estimated using the TerrPlant (v.1.2.2) model. As previously mentioned in the risk estimation section, a definitive NOAEC or EC 05 

### value was not determined in the available seedling emergence study and therefore listed species RQs could not be estimated for plants exposed to runoff and spray drift in dry and semi

- aquatic areas. The results of this screening

level assessment indicate that risk to terrestrial plants (monocots and dicots) in dry and semi aquatic areas is below the listed and non

- listed species LOC of 1 for exposure resulting from spray drift alone and below the non

- listed species LOC of 1 for plants in dry and semi

- aqua tic areas resulting from runoff and spray drift exposure. Listed species RQs in those two areas

could not be estimated based on the aforementioned lack of a definitive NOAEC. The NOAEC however, would have to be at least 10 times lower than the current no n

- definitive NOAEC to exceed the listed species LOC.- Page 93 of 137

- 

### 4.2.2.5. Risk to Birds and Mammals as a Result of Bioaccumulation in

Food Items

The results of KABAM indicate that acute dose and dietary

- based RQs and chronic dietary

based risk for birds as a resu lt of consuming fish contaminated by fluazinam are below acute and

chronic LOCs. Similarly , acute dose based and chronic dose and dietary

- based RQs to mammals

are also below acute and chronic LOCs.

Accord i ng to available data , fluazinam demonstrated some potential to bioaccumulate in fish. The maximum bioconcentration factors (BCF’s) were 348 L/kg for fillet, 1220 L/kg for whole fish, and 1850 L/kg for viscera, all of which were obtained with the phenyl label material. Depuration was moderate ( rep orted to be 5.0

- 6.0 days ). More than 67% of the residues were eliminated from the fillet during the 21

- day depuration phase. This suggests (and is supported by KABAM derived RQs) that while fluazinam has the potential to bioaccumulate in fish, that the

r ate of depuration rapid and complete enough to presume low risk to birds and mammals consuming fluazinam contaminated fish.



## 5. Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and the Federal Food, Drug, and Cosmetic Act ( FFDCA ) , EPA re views numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and g eneral or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reprod uctive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups . As part of the Preliminary Problem Formul ation for Registration Review (DP Barcode 345696) , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), fluazinam is subje ct to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 sc reening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the su bstance, and

establish a dose

- response relationship between the dose and the E, A, or T effect.- Page 94 of 137

- 

### Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingred ients. Fluazinam is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

ins, requiring the submission of EDSP s creening assays for fluazinam . For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.



## 6

. Federally Threatened and Endangered (Listed) Species of Concern

Based on this screening

- level assessment, there are potential risks of direct effects to listed birds, mammals, fresh water and estuarine/marine f ish, invertebrates and sediment

- dwelling

invertebrates , and aquatic non vascular plants from the use of fluazinam on some of its registered use sites. Listed species of birds, mmammals, freshwater and estuarine/marine fish, invertebrates, and sediment

- dwe lling invertebrates may also be affected through indirect effects because of the potential direct effects on listed and non

- listed species. Potential direct effects on

listed species within the previously mentioned taxa from the use of fluazinam may be as sociated with modification of primary constituent elements of designated critical habitats, where such designations have been made. However, a t this current stage of the Registration Review process, it is premature to make effects determinations for liste d species until further refinements are conducted. To make effects determinations for individual species, useful refinements may include analyses of 1) more detailed, species

- specific ecological and biological data; 2) more

detailed and accurate informati on on fluazinam use patterns; and 3) sub

- county level spatial proximity data for the co

- occurrence of potential effects areas and listed species and any designated critical habitat. Examples of such refinements are described below.

EFED is currently deve loping tools that are expected to further refine the assessment and are designed to support effects determinations for individual federally listed species and their designated critical habitats (where applicable). Scientific information obtained from the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS), and other reliable sources is being collated by EFED to address all currently listed species. The information will be stored in an Office of Pesticide Programs Pesticide R egistration Information SysteM (PRISM) knowledgebase. The listed species knowledgebase will consist of an information repository that houses biological and behavioral information relevant to individual species ( e.g. , habitat, diet, and life history, inclu ding specific temporal and spatial associations) and a document repository that contains supporting documents ( e.g ., USFWS recovery plans) and electronic information ( e.g ., GIS data files). For terrestrial taxa, the biological information

relevant to risk quotient (RQ) calculations ( e.g ., diet and body weight) will be used to parameterize exposure estimates to derive species

- specific RQs using a method consistent with currently used methods in the T

- REX and T

- HERPS models.

Refinements may also include m ore detailed analyses of the registered uses and their use patterns that result in LOC exceedances for federally listed species in the screening

- level assessment.- Page 95 of 137

- 

### The analyses may include more information on where, when, and how quizalofop

- p

- ethyl is used

on all use sites

. Actual usage data (when available) and national land

- cover datasets that indicate potential use sites [ e.g ., national land cover dataset (NLCD), crop data layer (CDL)] may be used to support a more refined analysis of where xxxxxxxxxxx is reasonably expected to be used. Similarly, refinements for the timing of applications and how xxxxxxxxxxxxxxxx is used may be based on the analysis of additional usage data, beyond what were available at the time of the screening

- level assessment, and a more in

- depth exploration of agronomic practices.

The U.S. Environmental Protection Agency, along with the U.S. Department of Agriculture (USDA), the U.S. Fish and Wildlife Service (FWS), and the National Marine Fisheries Service (NMFS), have announce d the availability of a report developed by the National Academy of Sciences’ National Research Council outlining recommendations on specific scientific and technical issues related to the development of endangered and threatened species risk

assessments f or pesticides that are compliant with the Endangered Species Act (ESA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA, USDA, FWS and NMFS asked the NRC to consider a range of scientific and technical issues including:

• identi fying best available scientific data and information;

• considering sub

- lethal, indirect and cumulative effects;

• assessing the effects of chemical mixtures and inert ingredients;

• analyzing the effects of pesticide use through the use of models;

• i ncorporating uncertainties into the evaluations; and

• using geospatial information and datasets that can be employed by the agencies in the

course of these assessments

.

After reviewing the NRC’s recommendations on these scientific and technical issues, the EPA and its federal partners will determine how these recommendations can be implemented and incorporated into the scientific approaches for developing listed species r isk assessments. It is anticipated that any draft guidance and/or science policies developed by EPA and its federal partners as a result of the NAS recommendations would be released for public comment prior to implementation.

The refinements based on ind ividual species data; additional, detailed usage information, when available; and further recommendations from the NRC report are expected to help to more accurately identify potential areas of effect and to better inform effects and habitat

determinations for listed species and any designated critical habitats. For example, if quizalofop

p

- ethyl is used when a particular species of concern is not present ( e.g ., it is migratory) or is not

co

- located in space, then risk of potential direct effects to the sp ecies may often be precluded. If LOCs are still exceeded for monocots, mammals, freshwater invertebrates, estuarine/marine invertebrates, and freshwater fish after conducting the refined analyses, further analyses of the potential spatial and temporal co

- occurrence of listed species of concern (and any designated critical habitat) may be conducted. The extent of possible refinement in the analyses of spatial/temporal co

- occurrence will largely depend on the scale and quality of the available sub

county le vel use site ( e.g ., NLCD, CDL) and species location data

.- Page 96 of 137

- 

### Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed sp ecies, and/ or the United States Fish and Wildlife Service ( US FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated critical habitat. Each federal agency is required under th e Act to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued exi stence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers , or distribution of the species" (50 C.F.R. § 402.02).

To facilitate compliance with the requirements of the Endangered Species Act (subsection (a)(2)), the Office of Pesticide Programs has established procedures to evaluate whether a proposed registrati on action may directly or indirectly appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,

or distributi on of any listed species (USEPA 2004). After the Agency’s screenin g level risk assessment is conducted, if any of the Agency’s listed species LOCs are exceeded for either direct or indirect effects, an analysis is conducted to determine if any listed or candidate species

may co

- occur in the area of the proposed pesticide use or areas downstream or downwind that

could be contaminated from drift or runoff/erosion. Given the existing national registrations and broad range of registered uses for fluazinam , the Agency has determined that listed species may be present in the a ction area. If listed or candidate species may be present in the action area, further biological assessment is undertaken. The extent to which listed species may be at risk is

considered

, which then determines the need for the development of a more compr ehensive consultation package, as required by the Endangered Species Act. The federal action addressed

herein is the registration review of existing uses for fluazinam

.

6 .1. Action Area

For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by fluazinam use and not merely the immediate area where fluazinam is applied. At the initial screening

- level, the risk assessment conside rs broadly described taxonomic groups and conservatively estimates exposure for organisms that are co

- located with the pesticide treatment area. This means that terrestrial plants and wildlife are assumed to be located on or adjacent to the treated site a nd aquatic organisms are assumed to be located in a surface water body adjacent to the treated site , except in the case of direct application to aquatic

habitat

.

6

. 2

. Taxonomic Groups Potentially at Risk

If the assumptions associated with the screeni ng

- level action area result in RQs that are below the listed species LOCs, a "no effect" determination conclusion is made with respect to listed species in that taxa, and no further refinement of the action area is necessary. Furthermore, RQs

below the li sted species LOCs for a given taxonomic group indicate no concern for indirect- Page 97 of 137

- 

### effects on listed species that depend upon the taxonomic group for which the RQ was calculated. However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that d epend upon that taxonomic group as a resource. In such cases, additional information on the biology of listed species, the locations of these species, and the locations of use sites are considered to determine the extent to which screening assumptions reg arding an action area apply to a particular listed organism. These subsequent refinement steps will consider how this information would impact the action area for a particular listed organism and potentially include areas of exposure that are downwind and downstream of the pesticide use site.

Assessment endpoints, exposure pathways, the conceptual model s addressing proposed new fluazinam uses, and the associated exposure and effects analyses conducted for the fluazinam screening

- level risk assessment are in Sections 2 to 3

. The assessment endpoints used in the screening

- level risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic and terrestrial animal species and survival, reproduction, and gr owth of aquatic and terrestrial plant species from both direct acute and chronic exposures. These assessment endpoints address the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action they authorize does no t appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species. Risk estimates (RQs) which, integrating exposure and effects, are calculated for b road based taxonomic groups in the screening

- level risk assessment presented in Section 4

.

Both acute and chronic risk to listed species LOCs are considered in the screening

- level risk assessment to identify direct and indirect effects to taxa of listed species. This section identifies direct effect concerns, by taxa, that are triggered by exceeding listed species LOCs in the screening

- le vel risk assessment ( Table 6.1 ) , with an evaluation of the potential probability of individual effects for exposures that may occur at the established listed species LOC ( Table 6.1 )

. Data on exposure and effects collected under field and laboratory conditions are evaluated to

make determinations on the predictive utility of the direct effect screening assessment findings to listed species. Additionally, the results of the screen for indirect effects to listed species, using direct effect acute and chronic LOCs for each taxonomic group, is presented and evaluated.

For terrestrial invertebrates, t he honey bee is used as a representative species to assess the risks of fluazinam use to listed species of this taxa . For characterization purposes, a toxicity value for

terrestrial invertebrates is calculat ed by multiplying the non definitive honey bee acute contact

LD 50 

### (> 200 μg ai/bee) for fluazinam by 1 bee/0.128 g, based on the average weight of an adult honey bee (Mayer and Johansen, 1990). Dietary

- based EECs calculated by T

- REX (μg ai/g) for arthropods are then divided by the adjusted toxicity value for terrestrial inv ertebrates (>1563 μg

a

. i

. /g). A summary of these T

- REX derived EECs for arthropods and the resultant RQs when compared to the adjusted toxicity value are tabulated below. The RQs are listed as non definitive “less than,” values since there were estimated with a non

- definitive “greater than,” toxicity value. While there is uncertainty in where this unbounded level of toxicity and therefore risk lies, there- Page 98 of 1 37

- 

### is some certainty in the fact that the RQs listed represent a “worst case,” scenario. All registere d

uses of fluazinam at least meet the interim terrestrial invertebrate LOC of 0.05. These values are difficult to interpret because no effects were observed in honey bees exposed to the limit dose. In the absence of additional data on the toxicity of hig her doses of fluazinam to terrestrial invertebrates, risk to listed species cannot be precluded at the screening level.

Table 6.1. Terrestrial Invertebrate RQs for Registered Uses of Fluazinam

Uses Represented Single App

Rate

(lb a.i./A) Max No. of Apps

a t Max

Rate Min.

Interval

Between Apps (days) Arthropod Dietary

- based

EEC (ppm) Terrestrial

Invertebrate RQ 1

Apple 0.45 10 7 245 <0.16 Brassica (Cole) Leafy Vegetables Crop Group 5, plus Turnip Greens 2.01 lb 1 N/A 189 <0.12

Bushberry 0.652 6 7 267 <0.17

Carrots 0.521 4 1 st at 14; then

7 161 <0.10

Ginseng 0.782 4 7 242 <0.15

Lettuce 0.782 1 N/A 74 <0.05

*Edible

- Podded Legume Vegetables

Crop Subgroup 6A, except peas; *Succulent Bean Crop Subgroup 6B; *Dry Bean Crop Subgroup 6C, except Peas and Soybeans 0.304 3 7 75 <0.05

Bulb Vegetables 0.521 6 7 214 <0.14 Cucurbit Vegetables, Melon 0.782 6 7 321 <0.21 Fruiting Vegetable, Pepper/ Eggplant 0.782 6 7 321 <0.21

Peanut 0.70 3 21 138 <0.09

Potato 0.261 7 7 118 <0.08 Soybean 0.521 2 10 89 <0.06

Turf grasses on golf courses 0.700 12 14 262 <0.17

Bolded and shaded values represent LOC exceedances

1 Interim terrestrial invertebrate LOC = 0.05 (EFED, 2007)



### Table 6. 1 . Potential Effects to Federally Listed Taxa Associated with Direct or Indirect

Effects from the Registered Uses of Fluazinam

.

Listed Plant Taxon Direct Effects Indirect Effects to Listed Taxon through Direct

Effects on ...

Terrestrial and semi

- aquatic pla nts

– monocots and dicots Uncertain 4 Birds, Mammals

Aquatic nonvascular plants Yes 1 Fish 1

Aquatic vascular plants Uncertain 5 Aquatic nonvascular plants,

Fish 1- Page 99 of 137

- Listed Plant Taxon Direct Effects Indirect Effects to Listed Taxon through Direct

Effects on ...

Listed Animal Taxon Direct Effects Indirect Effects to Listed Taxon through Direct

Effects on ... Acute Chronic

Terrestrial invertebrates Yes 6 ND Plants

Mammals No Yes 3 Plants

, Fish 1

, 2

Birds Yes Yes 3 Plants

, Fish 1, 2

Reptiles Yes Yes 3 Plants

A mphibians Yes 1 Yes 3 Plants

, Aquatic nonvascular plants, Fish 1

, Freshwater

invertebrates 1, Mammals

Freshwater fish Yes 1 Yes 3 Aquatic nonvascular plants,

Freshwater invertebrates 1

Freshwater invertebrates (crustaceans) Yes 1 No Aquatic nonvascular plants,

Fish 1

Mollus c s Yes 1 ND Aquatic nonvascular plants,

Fish 1

E stuarine /marine fish Yes 1 No Aquatic nonvascular plants,

Estuarine/marine

invertebrates 1

E stuarine /marine invertebrates (crustaceans) Yes 1 Yes 3 Aquatic nonvascular plants,

Fish 1

Freshwater benthic organisms Yes 1 Yes 3 Aquatic nonvascular plants,

Fish 1

Estuarine/marine benthic organisms Yes 1 Yes 3 Aquatic nonvascular plants,

Fish 1

ND = Not determined

1 Acute risk exceeds the listed species LOC only for fish, aquatic amphibians, and aquatic invertebrates exposed to at least one registered use of fluazinam

2 Indirect effects to birds and mammals that eat fish or amphibians.

3 Chronic risk exceeds the LOC for at least one registered use of fluazinam

4 NOAEC or EC 05 to estimate risk to listed species was not established definitively in available data

5 No data currently available to make determination

6 Interim LOC to terrestrial invertebrates (0.05) exceeded for all uses of fluazinam



### 6

. 3

. Listed Species Occurrence Associated with Registered Uses

The screening

- level risk assessment for fluazinam assumes that it may be applied nationwide, including U.S. territories and possessions. Therefore, no federally listed species are excluded from the screening level analyses, unless otherwise indicated ( e.g. , if only listed due to Similarity- Page 100 of 137

- 

### of Appearance to another listed species). A spatial co

- occurrence analysis that compares the best available data regarding fluazinam potential and documented use areas and listed species occurrence is needed to more explicitly address potential risk to listed species of concern. The Agency has requested data to support this analysis from the Federal Endangered Species Task Force (FESTF ).



## 7

. Conclusions

The risk hypothesis identified in the problem formulation stated , “G iven the uses of fluazinam

and its environmenta l fate properties, there is a likelihood of acute and chronic exposure to non

target aquatic and terrestrial organisms. Therefore, w hen used in accordance with the label,

fluazinam may result in adverse effects upon the survival, growth, and reproduction of non

- target aquatic and terrestrial plants and animals. ” After reviewing the most recent environmental fate

and effects data for fluazinam , the screening

- level assessment concludes that registered uses of

the fungicide fluazinam may result in risk to bo th listed and non

- listed species of aquatic and terrestrial animals, aquatic plants and wildlife.

Fluazinam appears to degrade at low to moderate rates in aerobic soils (152 and 221 days), but it is more rapidly transformed into other compounds of a sim ilar backbone structure in high pH solutions ( t 1/2 

### = 5.6 days at pH 9) or in a nae robic aquatic media (≤0.31 days for the parent only) or aerobic aquatic media (~0.33 to 8.3 days for the parent only). The transformation products of

fluazinam as a whole are considerably more persistent than the parent compound alone under most conditions. Fluazinam may be photolysed relatively rapidly in water (2.17 days) to form a tricyclic compound (G

- 504). The total fluazinam residues (fluazinam and its transformation

p roducts , which are considered the total toxic residues or TTR )

, are persistent in most environments ( e.g. , relatively stable to hydrolysis and in anaerobic aquatic environment)

, and are likely to reach aquatic media as a totality through runoff. F luazinam does not alter substantially

its backbon e structure in the environment; instead, it under goes slight transformations of functional groups, EFED has considered parent and certain transformation products in this

assessment

. EFED calculated the decay half

- l ives for the parent plus certain metabolites which were chosen according to ECOSAR toxicity predictions. While the parent and two transformation products, HYPA and CAPA, have relatively low mobility, indicating low potential for ground water contamination , there is uncertainty about the other transformation products . In the absence of other environmental fate data, given that the mobility of two of the degradates resembled the one for the parent, it was assumed that all the degradates have fate properties also resembling those of the parent compound

. Based on the properties of the chemical, applications of fluazinam are likely to reach the target (the crop), but drift is also possible. The total residues of fluazinam may reach adjacent bodies of water vi a runoff events and may be persistent.

When estimates of fluazinam exposure in terrestrial and aquatic environments are compared to the available ecotoxicity data, the results of the screening

- level assessment indicate a potential

for acute and chronic ri sk to birds, chronic risk to mammals , acute and chronic risk to freshwater fish, estuarine/marine invertebrates, and freshwater and estuarine/marine benthic invertebrates, acute risk to freshwater invertebrates and estuarine/marine fish, and risk to listed and non

- listed- Page 101 of 137

- 

### species of aquatic plants that exceed the Agency’s Level of Concern (LOC). All registered uses of fluazinam are expected to result in chronic risk to birds and mammals that exceeds the Agency’s LOC, although exposure and risk to strict gr anivores and frugivores is expected to be

lower and of less concern.

Off

- site transport of fluazinam to surface water presents risk to listed and non

- listed species of aquatic nonvascular plants ( e.g. , algae); it is uncertain to what degree algicidal o r algistatic effects in the aquatic plant community may result in indirect effects to other organisms. While available data suggest that fluazinam is practically non

- toxic to bees, risk to listed species of terrestrial invertebrates cannot be precluded.

Fluazinam (with its low solubility and moderately high K OW 

### and K OC 

### s ) has the propensity to bind to the sediment. A screening level analysis has shown fluazinam to pose chronic risk above the LOC in both the pore water and sediment compartments. Additio nally, fluazinam is shown to bioconcentrate in fish thus suggesting a route of exposure to birds and mammals that could consume fluazinam contaminated fish. However, a preliminary analysis shows that acute and chronic risk to birds and mammals consuming f ish exposed to fluazinam is below levels of concern, presumably based on fluazinam’s readiness to depurate rapidly from tissues.



## 8. Uncertainties, Limitations , and Identification of Data Gaps

8.1. Environmental Fate

8.1.1. Data Gaps Uncertainties

The environmental fate database for fluazinam is substantially complete. In an aerobic aquatic metabolism study, the levels of unextracted radioactivity were above 10% and there is uncertainty as to whether the authors did an earnest effort to extract all the radioactivity. The registrant should provide additional data supporting that all the fluazinam and the degradates of concern were extracted. However, the calculated half

- life was of the same order of magnitude than a previously submitted acceptable aero bic aquatic metabolism study.

The registrant is further required to address issues found in some environmental chemistry methods/independent laboratory validations.

8.1.2. Maximum Use Scenario

The screening

- level risk assessment focuses on characteriz ing potential ecological risks resulting from a maximum use scenario, which is determined from labeled statements of maximum application rate and number of applications with the shortest time interval between applications. The frequency at which actual us es approach this maximum use scenario may be dependent on pest resistance, timing of applications, cultural practices, and market forces.- Page 102 of 137

- 

### 8.1.3

. Aquatic Modeling with PRZM/EXAMS

The theoretical fluazinam concentration in soil for application rates rang ing from 0.782 to 3.1 lb

a.i./A would be 0.4

- 1.5 ppm, which is much higher than the solubility of fluazinam at environmental pH (71 ppb). The chemical could dissolve or be released slowly and cause that the expected concentrations be higher than modeled s ince PRZM/EXAMS cannot account for this issue. Furthermore, the sediment EECs are expected to also be higher. In soils, fluazinam TTRs degrade with calculated half

- lives of 189

- 221 days. Meanwhile, in sediments, the aerobic

half

- lives were 11.7

- 32.6 day s and the anaerobic aquatic appeared to be relatively stable. Since the retreatment intervals are usually 7

- 14 days with repeated applications, given the low solubility of fluazinam and expected low solubility of its transformation products, its high appl ication rates, and the relatively high persistence of the TTRs, soils and sediments could become repositories of fluazinam TTRs.

The standard ecological water body scenario (EXAMS pond) used to calculate potential aquatic exposure to pesticides such as fl uazinam is intended to represent conservative estimates, and to avoid underestimating the actual exposure. The standard scenario consists of application to a 10

- hectare field bordering a 1

- hectare, 2

- meter deep (20,000 m 3 

### ) pond with no outlet. Exposure

e stimates generated using the EXAMS pond is intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man

- made and natural ponds, and intermittent an d lower order streams. As a group, there are factors that make these water bodies more or less vulnerable than the EXAMS pond. Static water bodies that have larger ratios of pesticide

- treated drainage area to water body volume would be expected to have h igher peak EECs than the EXAMS pond. These water bodies will be either smaller in size or have larger drainage areas. Smaller water bodies have limited storage capacity and thus may overflow and carry pesticide in the discharge, whereas the EXAMS pond ha s no discharge. As watershed size increases beyond 10

- hectares, it becomes increasingly unlikely that the entire watershed is planted with a single crop that is all treated simultaneously with the pesticide. Headwater streams can also have peak concentra tions higher than the EXAMS pond, but they likely persist for only short periods of time and are then carried and dissipated downstream.

The Agency acknowledges that there are some unique aquatic habitats that are not accurately captured by this modeling scenario and modeling results may, therefore, under

- or over

- estimate exposure, depending on a number of variables. For example, some organisms may inhabit water bodies of different size and depth and/or are located adjacent to larger or smaller drainage areas than the EXAMS pond. However, the existing EXAMS pond represents the best currently available approach for estimating aquatic exposure to pesticides

.

In general, the linked PRZM/EXAMS model produces EECs that are expected to be exceeded

once within a ten

- year period. The Pesticide Root Zone Model is a process or “simulation” model that calculates what happens to a pesticide in an agricultural field on a day

- to

- day basis. It considers factors such as rainfall and plant transpiration of water, as we ll as how and when the pesticide is applied. It has two major components: hydrology and chemical transport. Water movement is simulated by the use of generalized soil parameters, including field capacity,- Page 103 of 137

- 

### wilting point, and saturation water content. Th e chemical transport component can simulate pesticide application on the soil or on the plant foliage. Dissolved, adsorbed, and vapor

- phase concentrations in the soil are estimated by simultaneously considering the processes of pesticide uptake by plants, surface runoff, erosion, decay, volatilization, foliar wash

- off, advection, dispersion, and retardation.

Uncertainties associated with each of these individual components add to the overall uncertainty of the modeled concentrations. Additionally, model inputs from the environmental fate degradation studies are chosen to represent the upper confidence bound on the mean values that are not expected to be exceeded in the environment approximately 90 percent of the time. Mobility input values are chosen to be representative of conditions in the environment. The natural variation in soils adds to the uncertainty of modeled values. Factors such as application date, crop emergence date, and canopy cover can also affect estimated concentrations, adding to

the uncertainty of modeled values. Factors within the ambient environment such as soil temperatures, sunlight intensity, antecedent soil moisture, and surface water temperatures can cause actual aquatic concentrations to differ for the modeled values

.

8.1. 4

. Buffer Zone to Estuarine/Marine Bodies of Water

According to the label for Omega ® 

### 500F (EPA Reg. No. 71512

- 1), there is a restriction for aerial applications near estuarine/marine environments. A buffer zone of 150 ft towards those bodies of water is imposed. A similar buffer is not applicable towards freshwater bodies of water.

Add itionally, fluazinam should not be applied within 25 feet of permanent water bodies ( such as lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, and estuaries). Unlike spray drift, tools are currently not available to evaluate the effe ctiveness of a vegetative setback on runoff and loadings. The effectiveness of vegetative setbacks is highly dependent on the condition of the vegetative strip. For example, a well established, healthy vegetative setback can be a very effective means of reducing runoff and erosion from agricultural fields. Alternatively, a setback of poor vegetative quality or a setback that is channelized can be ineffective at reducing loadings. Until such time as a quantitative method to estimate the effect of vegetat ive setbacks on various conditions on pesticide loadings becomes available, the aquatic exposure predictions are likely to overestimate exposure where healthy vegetative setbacks exist and underestimate exposure where poorly developed, channelized, or bare setbacks exist.

The registrant submitted a supplemental study in which runoff from a peanut field in Georgia

was evaluated. In the study, t he buffer zone from the treated field was 10 ft wide (while the label requires 25 ft). Fluazinam runoff reduction s ranged from 1.2 to 58.3%, depending on how the runoff was measured and the particular plot. Since the infiltration rates exceeded the rainfall intensity of the simulated rainfall , suggesting that the soil may have absorbed the rainfall, the study cannot be used quantitatively for risk assessment purposes.

8.1.5

. Uncertainties regarding dilution and chemical transformations

in estuaries

PRZM/EXAMS modeled EECs are intended to represent exposure of aquatic organisms in- Page 104 of 137

- 

### relatively small ponds and low

- order streams. Therefore it is likely that EECs generated from

the PRZM/EXAMS model will over

- estimate potential concentrations in larger receiving water bodies such as estuaries, embayments, and coastal marine areas because chemicals in runoff water (or spray drift, etc. ) should be diluted by a much larger volume of water than would be found in the ‘typical’ EXAMS pond. However, as chemical constituents in water draining from

freshwater streams encounter brackish or other near

- marine

- associated conditions, th ere is potential for important chemical transformations to occur. Many chemical compounds can undergo changes in mobility, toxicity, or persistence when changes in pH, E h 

### (redox potential), salinity, dissolved oxygen (DO) content, or temperature are encou ntered. For example, desorption and re

- mobilization of some chemicals from sediments can occur with changes in salinity (Jordan et al. , 2008; Means, 1995; Swarzenski et al. , 2003) , changes in pH ( e.g ., Wood and Baptista 1993; Parikh et al. 2004; Fernandez et al. 2005), E h 

### changes (Velde and Church, 1999; Wood and Baptista, 1993) , and other factors. Thus, although chemicals in discharging rivers may be diluted by large volumes of water within receiving estuaries and embayments, the hydrochemistry of the marine

- influenced water may negate some of the attenuating impact of the greater water volume; for example, the effect of dilution may be confounded by changes in chemical mobility (and/or bioavailability) in brackish water. In addition, freshwater

contri butions from discharging streams and rivers do not instantaneously mix with more saline water bodies. In these settings, water will commonly remain highly stratified, with fresh water lying atop denser, heavier saline water

– meaning that exposure to conc entrations found in discharging stream water may propagate some distance beyond the outflow point of the stream (especially near the water surface). Therefore, it is not assumed that discharging water will be rapidly diluted by the entire water volume wit hin an estuary, embayment, or other coastal aquatic

environment. PRZM/EXAMS model results should be considered consistent with concentrations that might be found near the head of an estuary unless there is specific information

– such as monitoring data

– to indicate otherwise. Conditions nearer to the mouth of a bay or estuary, however, may be closer to a marine

- type system, and thus more subject to the notable buffering, mixing, and diluting capacities of an open marine environment. Conversely, tidal ef fects (pressure waves) can propagate much further upstream than the actual estuarine water, so discharging river water may become temporarily partially impounded near the mouth (discharge point) of a channel, and resistant to mixing until tidal forces are reversed.

The Agency does not currently have sufficient information regarding the hydrology and hydrochemistry of estuarine aquatic habitats to develop alternate scenarios for assessed listed species that inhabit these types of ecosystems. The Agency ack nowledges that there are unique brackish and estuarine habitats that may not be accurately captured by PRZM/EXAMS modeling results, and may, therefore, under

- or over

- estimate exposure, depending on the aforementioned

variables.

8.2. Ecological Effects

Th ere are a number of areas of uncertainty in the aquatic and terrestrial risk assessments. The toxicity assessment for terrestrial and aquatic plants and animals is limited by the number of species tested in the available toxicity studies. Use of toxicity data on representative species- Page 105 of 137

- 

### does not provide information on the potential variability in susceptibility to acute and chronic

exposures.

For each proposed use, the risk assessment is based on the maximum application rate on the proposed label. The fre quency at which actual uses approach these maximum scenarios is dependent on the resistance to the pesticide, the timing of applications, and market forces. Exposure and risks could be overestimated if the actual application rates, frequency of application , or number of applications are lower than the input parameters used for the conservative exposure scenario that was modeled. However, if there are conditions under which there is more than one growing season for a crop within a single year, exposure esti mates and risk to aquatic and terrestrial organisms could be significantly underestimated.

8.2.1. Terrestrial Exposure Assessment

This risk assessment relies on the best available estimates of environmental fate and physicochemical properties, maximum application rate of fluazinam , maximum number of applications, and the shortest interval between applications. However, several uncertainties and model limitations are noted and should be considered in interpreting the results of this terrestrial

risk ass essment.

8.2.1.1. Uncertainties Associated with T

- REX

T here is uncertainty in the RQs generated by T

- REX for all registered uses of fluazinam relating to the foliar dissipation half life. T

- REX uses a default foliar dissipation half life of 35 days in

the absence of 3 or more values that are derived from stud ies demonstrating that the foliar dissipation half life is less than 35 days. For fluazinam, there are two foliar dissipation studies

avai l ab l e ( peanut and potato, MRID 46991302 , and 46991303

, 

### respectively ) that estimated a foliar dissipation half life of 7.33 days. Using the cucurbit use as an example, T

- REX was run with the study derived foliar dissipation half life of 7.33 days instead of the default 35 days. The results indicate that acute and chronic RQs are roughly one half for dose and dietary

- bas ed RQs to birds and mammals. If approximately the same results are shown to be true for all uses of fluazinam, while acute and chronic RQs would be reduced, it would not entirely eliminate acute

risk to birds or chronic risk to birds and mammals. Under t he 35 day assumption of foliar dissipation half life in T

- REX there were three registered uses of fluazinam (apples, cucurbits, and fruiting vegetables) that exceeded all acute LOCs for birds and all registered uses exceeding at least the acute endangered species LOC. Using a 7.33 day dissipation half life would result in no uses exceeding the acute high risk LOC but 12 of 14 (86%) registered uses would still exceed the acute endangered species LOC for at least one food item for birds. For chronic risk to birds, using a lower half life would result in 9 of 14 uses (64%) that exceed the chronic LOC for at least one food item compared to 13 of 14 (93%) of uses that exceed the chronic LOC with

default half life.

For mammals, there was no acute LOC exceedance s using the default half life and so these RQs

would be further reduced. For chronic risk, every registe red use of fluazinam exceeded the

chronic LOC for mammals for all sizes classes and at least one food item. With the use of the- Page 106 of 137

- 

### lower 7.33 d ay half li fe, this risk finding would still remain true. While there is uncertainty in the fact that these RQs may be lower as a result of shorter half lives demonstrated by available data, even the employment of this data would not change the overall risk picture from how it currently stands in terms of determinations.

8.2.2. Routes of Exposure

Dietary Exposure

Screening

- level risk assessments for spray applications of pesticides assume that 100% of the diet is relegated to single food types foraged only from treated fields. These assumptions are likely to be conservative for many species and will tend to overest imate potential risks. The assumption of 100% diet from a treated area may be realistic for acute exposures, but long

- term exposures modeled as single food types composed entirely of material from a treated field is

uncertain.

Dermal Exposure

The screen ing assessment does not consider fluazinam dermal exposure to terrestrial organisms. The Agency is actively pursuing modeling techniques to account for dermal exposure via direct application of spray and by incidental contact with contaminated vegetation, soil and water.

8.2.3. Age Class and Sensitivity of Effects Thresholds

It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxi cant. The screening risk assessment acute toxicity data for fish are collected on juvenile fish and aquatic invertebrate acute testing is performed on recommended immature age classes. Similarly, acute dietary testing with birds is also performed on juven iles, with mallard being 5

- 10 days old and quail at 10

- 14 days of age.

Testing of juveniles may overestimate the toxicity of direct acting pesticides in adults. As juvenile organisms do not have fully developed metabolic systems, they may not possess th e ability to transform and detoxify xenobiotics equivalent to the older/adult organism. The screening risk assessment has no current provisions for a generally applied method that accounts for this uncertainty. In so far as the available toxicity data may provide ranges of sensitivity information with respect to age class, the risk assessment uses the most sensitive life

- stage information as the conservative screening endpoint.

8.2.4. Lack of Effects Data for Amphibians and Reptiles

Currently, toxicity studies on amphibians and reptiles are not required for pesticide registration. Since these data are lacking, the Agency uses fish as surrogates for aquatic phase amphibians and

birds as sur rogates for terrestrial phase amphibians and reptiles. If other species are more or less

sensitive to fluazinam than the surrogates, risks may be under

- or overestimated, respectively.- Page 107 of 137

- 

### The Agency is not limited to a base set of surrogate toxicity informati on in establishing risk assessment conclusions. The Agency also considers toxicity data on non

- standard test species when available. Further research is needed to determine whether, in general, reptiles and

terrestrial

- phase amphibians are suitably repres ented by bird species in assessing risks for

fluazinam and fish are an appropriate surrogate for aquatic

- phase amphibians.

8.2.5. Use of the Most Sensitive Species Tested

Although the screening risk assessment relies on a selected toxicity endpoint from the most sensitive species tested, it does not necessarily mean that the selected toxicity endpoints reflect sensitivity of the most sensitive species existing in a given en vironment. The relative position of the most sensitive species tested in the distribution of all possible species is a function of the overall variability among species to a particular chemical. The relationship between the sensitivity of the most sensit ive tested species versus wild species (including listed species) is unknown and a source of significant uncertainty. In addition, in the case of listed species, there is uncertainty regarding the relationship of the listed species' sensitivity and the mos t sensitive species tested.

There is conservatism and some uncertainty with two of the modeled scenarios for fluazinam. For the brassica (cole) leafy vegetables scenario, the labels state that the chemical can either be applied as a soil drench or be a pplied and be soil incorporated at a depth of 6 inches. T

- REX does not have the capability of reliably estimating exposure for either of these scenarios as it

does not have a soil drench method nor does it allow for a soil incorporation depth as

PRZM/EXAM S does with its chemical application method ( CAM ) input. As a result, brassica was modeled at the higher of the two application rates for those scenarios (2.01 lbs a.i

. /A

– soil drench method) as a foliar spray. The resultant dose and dietary

- based EECs for birds are therefore potentially greater than they would be than under an actual soil drench exposure scenario in which the chemical typically does not get exposed to foliage . It is worth noting that despite these highly conservative EECs for the brass ica scenario, there are still other uses of fluazinam with traditional foliar applications that result in higher EECs and therefore RQs.

Additionally, for the carrot scenario, the label stipulates that the application interval is 14 days

between the first and second application, and then 7 days for the interval for each subsequent application. While T

- REX can simulate variable application rates ( e.g. , 1.5 lbs a.i

. /A for two applications followed by 1.0 lbs a.i

. /A for two applications), it does not have th e capability to model variable application intervals. As a result, this use was modeled using the more

conservative approach of using the 7 day application interval for all applications. As with the brassica use, despite this conservatism there were other uses of fluazinam that resulted in higher EEC and therefore RQs, that is, this use did not represent the highest r isk for fluazinam to birds.

Organisms consume a variety of dietary items and may exist in a variety of sizes at different life stages. For foliar applications of liquid formulations, T

- REX estimates exposure for the following dietary items: short grass, tall grass, broadleaf plants/small insects, fruits/pods/seeds/ large insects, and seeds for granivores. Birds (used as a surrogate for amphibians and reptiles), and mammals, consume all of these items. The size classes of birds represented in T

- REX are- Page 108 of 137

- 

### the small (20 g), medium (100 g), and large (1000 g). The size classes for mammals are small (15 g), medium (35 g), and large (1000 g). EECs are calculated for the most sensitive dietary

item and size class for birds (surrogate for terrestrial

- phase amph ibians and reptiles) and

mammals. Table 6

- 1 shows the percentages of the EECs and RQs of the various dietary classes for each size class as compared to the most sensitive dietary class (short grass) and size class (small mammal or bird). This information could be used to further characterize potential risk that is specific to the diet of birds and mammals. For example, if a mammal only consumes broadleaf plants and small insects and the RQ was 100 for small mammals consuming short grass, the RQ for small mammals that only consumed broadleaf plants and small insects would be 56 (100 x 0.56).

Table 8.1. Percentage of EEC or RQ for the Specified Dietary Items and Size Classes as Compared to the EEC or RQ for The Most Sensitive Dietary Items (Short Grass) and Size Class (Small Bird or Small Mammal)

Dietary Items Percentage of EECs or RQ s for the S pecified Dietary Items and Size Class as compared to the EEC or RQ for Small Birds 1 or Small Mammals Consuming Short Grass

Birds: Dose Based EECs and RQs

Size Class Small, 20 g Mid, 100 g Large, 1000 g

EEC RQ EEC RQ EEC RQ

Short Grass 100% 100% 57% 45% 26% 14%

Tall Grass 46% 46% 26% 21% 12% 7% Broadleaf plants/sm all

Insects 56% 56% 32% 25% 14% 8% Fruits/pods/seeds/l arge insects 6% 6% 4% 3% 2% 1%

Granivores 1% 1% 1% 1% 0.4% 0.2%

Mammals: Dose

- Based EECs and RQs

Size Class Small, 15 g Mid, 35 g Large, 1000 g

EEC RQ EEC RQ EEC RQ

Short Grass 100% 100% 69% 85% 16% 46%

Tall Grass 46% 46% 32% 39% 7% 21% Broadleaf plants/sm all

Insects 56% 56% 39% 48% 9% 26% Fruits/pods/seeds/large

insects 6% 6% 4% 5% 1% 3%

Granivores 1% 1% 1% 1% 0.2% 0.6%
Mammals and Birds: Dietary

- based EECs and RQs for all Size Classes 2

Short Grass 100 %

Tall Grass 46 %
Broadleaf plants/sm Insects 56 %
Fruits/pods/seeds/lg insects 6 %

1 The percents of the maximum RQ shown here for birds are based on the Agency’s default avian scaling factor of

1.15.

2 Percentages for dose

- based chronic EECs and RQs for mammals are equivalent to the acute dose

- based EEC s and RQs.



### In the risk assessment, RQs were only calculated for the most sensitive dietary class relevant to- Page 109 of 137

- 

### the organisms assessed. For most organisms, not enough data is available to conclude that birds or mammals may not exclusively feed on a dietar y class for at least some time period. However, most birds and mammals consume a variety of dietary items and thus the RQ will overestimate risk to those organisms. Additionally, some organisms will not feed on all of the dietary classes. For example, m any amphibians would only consume insects and not any plant material.

8.2.7. Sublethal Effects

When assessing acute risk, the screening risk assessment relies on the acute mortality endpoint as well as a suite of sublethal responses to the pesticide, as determined by the testing of species response to chronic exposure conditions and subsequent chronic risk assessment. Consideration

of additional sublethal data in the effects determination is exercised on a case

- by

- case basis and only after careful conside ration of the nature of the sublethal effect measured and the extent and quality of available data to support establishing a plausible relationship between the measure of effect (sublethal endpoint) and the assessment endpoints. However, the full suite of sublethal effects from valid open literature studies is considered for the characterization purposes.

To the extent to which sublethal effects are not considered in this assessment, the potential direct and indirect effects of fluazinam on listed specie s may be underestimated.

8.2.8. Ecological Effects Data Gaps

The ecological effects data profile for fluazinam is essentially complete. Although there are no acceptable studies submitted for a freshwater diatom or a vascular aquatic plant, available dat a and risk estimates suggest that all registered uses of fluazinam pose a risk to listed and non

- listed aquatic plant species. The available data for terrestrial plants did not achieve a definitive NOAEC for seedling emergence with which to estimate a lis ted species RQ. Other terrestrial plant listed and non

- listed RQs that were able to be estimated from available data indicate that risk to terrestrial plants is below LOC. There are no available data for the effects of fluazinam to

estuarine/marine benth ic organisms. Although acute and chronic risk based on pore water was

estimated for this taxa, whole sediment studies would allow for the risk estimation of chronic risk to estuarine/marine benthic invertebrates expressed in terms of sediment concentratio ns.



## 9. References

American Bird Conservancy (ABC). 2007. Avian Incident Monitoring System. Available

online at http://www.abcbirds.org/abcprograms/policy/pesticides/aims/aims/simple.cfm

.- Page 110 of 137

- 

### Di Toro, DM, CS Zarba, DJ Hansen, WJ Berry, RC Swartz, CE Cowan, SP Pavlou, HE Allen, NA Thomas and PR Paquin. 1991. Technical basis for establishing sediment quality

criteria for nonionic organic chemicals using equilibrium partitioning. Environ. Toxicol.

Chem. 10:1541

- 1583.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the

EPA food

- chain (Kenaga) nomogram, and instrument for es timating pesticide residues on plants. Environmental Toxicology and Chemistry 13 (9):1383

- 1391.

FAO. 2000. Appendix 2. Parameters of pesticides that influence processes in the soil. In FAO Information Division Editorial Group (Ed.), Pesticide Disposal Se ries 8. Assessing Soil Contamination. A Reference Manual. Rome: Food & Agriculture Organization of the United Nations (FAO). ( At http://www.fao.org/docrep/003/X2570E/X2570E00.HTM

, Accessed Apr il 8, 2013 ).

Food and Agriculture Organization of the United Nations. FAO PESTICIDE DISPOSAL

SERIES 8. Assessing Soil Contamination: A Reference Manual. Appendix 2. Parameters of pesticides that influence processes in the soil. Editorial Group, FAO

In formation Division: Rome, 2000. http://www.fao.org/DOCREP/003/X2570E/X2570E00.htm (accessed March 27, 2013 )

Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative data as a basis for estimation of their magnitude in the environment. In F. Coulston and F. Korte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology, Georg Thieme Publ, Stuttgart, West Ger many, pp. 9

- 28.

Urban, D.J., and N. Cook. 1986. Ecological Risk Assessment . EPA 540/9

– 85

- 001. Office of Pesticide Programs. Washington, D.C.: U.S. Environmental Protection Agency.

USDA 2000. Conservation Buffers to Reduce Pesticide Losses. Natural Res ources Conservation Service. 25 pp.

US E PA 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. 2002. Technical Basis for the derivation of Equilibrium Partitioning Sediment Guidelines (ESGs) for the Protection of Benthic Organisms: Nonionic Organics [Draft].

EPA Document No. 822R02041. October 2002.

USEPA 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species- Page 111 of 137

- 

### Effects Determinations. Offi ce of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D.C. Available online at http://www.epa.gov/oppfead1/endanger/consultation/ec orisk

- overview.pdf

.

USEPA 2005. EXAMS User’s Manual. Online at: http://www.epa.gov/ceampubl/swater/exams/index.html

USEPA 2006a. PRZM User’s Manual. Online at: http://www.epa.gov/ceampubl/gwater/przm3/index.html

USEPA 2006b, TerrPlant v. 1.2.2 User’s Guide. Office of Pesticide Programs, Environmental Fate and Effects Division, Washington, D.C. December 26, 2006.

USEPA 2009 a . Models Data Bases : available online and accessed 03/27/2013 at http://www.epa.gov/pesticides/science/models_db.htm

.

USEPA 2009b. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version 2.1. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division, October 22, 2009 and issued November 10 , 2009. Available online a t: http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm (accessed 03/27/2013).

US EPA 2009c. ECOTOXicology Database, v. 4.0. Accessed March 2013. Ava ilable online at http://cfpub.epa.gov/ecotox/

.

USEPA 2009d. Ecological Incident Information System, v. 2.1 . Accessed on 11 August 2012. Description online at http://www.epa.gov/pesticides/science/models_db.htm

.

8 .1

. Submitted Environmental Fate Studies

MRID 42208412

. Flude, P.; Evans, J.; Cavell, B. (1992) Fluazinam Technical B1216: Hydrolysis at pH 5, pH 7 and at 22 C: Lab Project Number: RJ0383B. Unpublished study prepared by ICI Plant Protection Division. 25 p.- Page 112 of 137

- MRID 42208413

. Bharti, H.; Bewick, D. (1992) Fluazin am Technical B1216, PP192: Degradation in Soil: Lab Project Number: RJ0444B. Unpublished study prepared by ICI Plant Protection Division. 89 p.

MRID 42248626

. Baker, C.; Lavery, M.; Evans, J.; et al. (1992) Fluazinam Technical (B11216): Photodegradation of ?Carbon 14| B1216 in Water: Lab Project Number: RJO419B. Unpublished study prepared by ICI, Jealott's Hill. 44 p.

MRID 43521009

. Lentz, N.; Korsch, B. (1994) Fluazinam Technical: Photolysis in Water at pH 5: Interim Report: Lab Project Number: 5312

- 94

- 0119

- EF

- 001: 94

- 0119. Unpublished study prepared by Ricerca, Inc. 110 p.

MRID 44807312

. Lentz, N.; Korsch, B. (1995) A Photolysis Study of IKF

- 1216 (Fluazinam) in Water at pH 5: Final Report: Lab Project Number: 5312

- 94

- 0119

- EF

- 002: 94

- 0119: 5312

- 94

- 0119

- EF

- 000

-

. Unpublished study prepared by Ricerca, Inc. 82 p.

MRID 45584204

. Doran, T. (2001) Rebuttal Response to Upgrade Aqueous Photolysis: A Photolysis Study of IKF

- 1216 (Fluazinam) in Water at pH 5

-- Interim and Final Reports: Lab Project Number: IB

2001

- MAP

- 008

- 01: 5312

- 94

- 0119

- EF

- 002. Unpublished study prepared by Ricerca, LL C. 13 p.

MRID 44807313

. Lentz, N.; Korsch, B. (1995) A Photolysis Study of IKF

- 1216 (Fluazinam) on Soil: Lab Project Number: 5313

- 95

- 0011

- EF

- 001: 95

- 0011: 5313

- 95

- 0011

- EF

- 000. Unpublished study prepared by Ricerca, Inc. 127 p.

MRID 45584205

. Doran, T. (2001) Rebuttal Response to Upgrade Soil Photodegradation: A Photolysis Study of IKF

- 1216 (Fluazinam) on Soil: Lab Project Number: IB

- 2001

- MAP

- 009

- 01: 5313

- 95

- 0011

- EF

001. Unpublished study prepared by Ricerca, LLC. 10 p.

MRID 45584206

. Lentz, N.; Korsch, B. (2001) A Photolysis Study of IKF

- 1216 (Fluazinam) on Soil: Amended Report : Lab Project Number: 5313

- 95

- 0011

- EF

- 002. Unpublished study prepared by Ricerca, LLC. 141 p.

MRID 42208413

. Bharti, H.; Bewick, D. (1992) Fluazinam Technical B1216 , PP192: Degradation in Soil: Lab Project Number: RJ0444B. Unpublished study prepared by ICI Plant Protection Division. 89 p.

MRID 42208414

. Askew, P.; Hill, I. (1992) Fluazinam Technical: A Comparison of the Microflora and Physico

- Chemical Properties o f Soils Used in UK Laboratory Studies and Those of US Soils: Supplementary Data: Lab Project Number: RJ0429B. Unpublished study prepared by ICI Plant Protection Division. 31 p.

MRID 43521010

. Obrist, J.; Bashir, M. (1994) Fluazinam Technical: Anaerobic Aquatic Metabolism: Lab Project Number: 5436

- 92

- 0345

- EF

- 001: HWI 6241

- 104. Unpublished study prepared by Hazleton Wisconisn, Inc. 156 p.

MRID 44807314

. Landphair, C. (1996) An Aerobic Aquatic Soil Metabolism Study with (carbon 14) IKF

1216: Lab Project Number: 6100

- 94

- 0100

- EF

- 001: 94

- 0100: 6100

- 94

- 0100

- EF

- 000. Unpublished study prepared by Ricerca, Inc. 124 p.

MRID 42208415

. Bewick, D.; White, R. (1992) Fluazinam Technical B1216, PP192: Leaching of Fluazinam and its Degradation Products in Soil Column s: Lab Project Number: RJ0434B. Unpublished study prepared by ICI Plant Protection Division. 31 p.

MRID 42248627

. Bewick, D.; Stevens, J. (1992) Fluazinam Technical (B1216): Leaching in Soil Thick

Layer Chromatograms: Lab Project Number: RJO421B. Unpubl ished study prepared by ICI, Jealott's Hill. 35 p.

MRID 42248628

. Galicia, H.; Volkl, S. (1991) Fluazinam Technical (IFK (sic) 1216): Soil Adsorption/ Desorption on Four Soils: Lab Project Number: 282306. Unpublished study prepared by RCC

Umweltchemie A g. 75 p.- Page 113 of 137

- MRID 43528201

. Muller, K.; Lane, M. (1993) Fluazinam: Adsorption and Desorption Properties in Soil of R270682 ("HYPA"), a Major Soil Metabolite: Lab Project Number: RJ 1308B: 92JH027. Unpublished study prepared by ICI Agrochemicals. 62 p.

MRID 44807315 Shelby, D. (1995) Adsorption and Desorption of CAPA to Soil: Lab Project Number:

6168

- 94

- 0138

- EF

- 001: 6168

- 94

- 0138

- EF

- 000: F93216

- 083. Unpublished study prepared by Ricerca, Inc. 115 p.

MRID 44807316. Crawford, C.; Dillon, K. (1996) Stabi lity of Fluazinam and its Metabolites (MAPA, HYPA and CAPA) in Soil: Lab Project Number: 5900

- 93

- 0285

- CR

- 002: 93

- 0285: 5900. Unpublished study prepared by Ricerca, Inc. 232 p. {OPPTS 860.1380}

MRID 44807319. Crawford, C.; Dillon, K. (1995) Dissipation o f Residues of Fluazinam and its Metabolites (MAPA, HYPA and CAPA) from Soil in Georgia: Lab Project Number: 5687

- 93

- 0104

- CR

- 001: 93

- 0104: 5687. Unpublished study prepared by Ricerca, Inc. 470 p.

MRID 44807320

. Crawford, C.; Dillon, K. (1995) Dissipation of Residues of Fluazinam and its Metabolites (MAPA, HYPA and CAPA) from Soil in Washington: Lab Project Number: 5687

- 93

- 0091

- CR

- 001: 93

- 0091: 1216JKZ

- 2. Unpublished study prepared by Ricerca, Inc. 461 p.

MRID 45584207

. Shah, J.; Kenyon, R. (2001) Terre strial Dissipation Study with Fluazinam: Amended Report : Lab Project Number: 96

- JRF

- 04

- 002: 6887

- 96

- 0130

- CR

- 001: 6887

- 96

- 0130

- CR

- 001

- 001. Unpublished study prepared by Ricerca, LLC. 586 p.

MRID 45584208

. Shah, J.; Crawford, C. (2001) Terrestrial Dissipa tion Study with Fluazinam: Amended Report : Lab Project Number: 96

- JRF

- 05

- 002: 6886

- 96

- 0129

- CR

- 001: 6886

- 96

- 0129

- CR

- 001

- 001. Unpublished study prepared by Ricerca, LLC. 599 p.

MRID 43521011

. Robinson, R.; Hoffman, S. (1994) Fluazinam Technical: Confined Rotational Crop: Part 1 (Total Radioactive Residue Determination, Residue Extraction and Profiling, and Isolation and Identificaton of Trifluroacetic Acid): Lab Project Number: 5032

- 92

- 0093: XBL92071: 92120. Unpublished study prepared by Xenobiotic Labs, I nc. 271 p.

MRID 44807321

. Robinson, R.; Hoffman, S. (1995) Confined Rotational Crop Study on Fluazinam (IKF

1216): Lab Project Number: 5032

- 92

- 0093: XBL92071: RPT00207. Unpublished study prepared by Xenobiotic Laboratories, Inc. 186 p.

MRID 43521012

. Lentz, N.; Huhtanen, K. (1994) Fluazinam Technical: Uptake, Depuration, Bioconcentration and Metabolism in Bluegill Sunfish (Lepomis macrochirus) (Under Flow Through Test Conditions): Lab Project Number: 5311

- 93

- 0013

- EF

- 001: 93

- 0013. Unpublished study pre pared by Ricerca, Inc. 236 p.

MRID 44807330

. Coody, P.; White, J.; Formanik, J. (1996) Fluazinam Runoff from Peanuts under Heavy Rainfall and Transport Reduction Resulting from Adjacent Buffer Strips: Lab Project Number: 1901: 938:

6456

- 95

- 0094

- CR

- 000. Unpublished study prepared by Ricerca, Inc. 366 p. {OPPTS 850.1950}

MRID 47167501

. Leyes, G. (2007) Fluazinam Tier 1 Risk Assessment

- Use of Aerial Spray on Potato. Project Number: IB/2007/GAL/001/01. Unpublished study prepared by Isk Biosciences Corporation. 8 p.

MRID 46991302

. Wiedmann, J.L. Foliar dissipation of fluazinam from peanut leaves treated with 0 r n e ~ a @ 5 0 0in~ 2

- 0~04~. ~Un published study performed by EN

- CAS Analytical Laboratories,

Winston

- Salem, North Carolina and Agricultural Systems Associates, Kinston, North Carolina;spon sored by Ishihara Sangyo Kaisha, Ltd., Osaka, Japan; and submitted by ISK Biosciences Corporation, Concord, Ohio. ISKB Study Number: IB

- 2004

- JLW

- 00 1

- 0 1

- 0 1. EN

- CAS Study Identification Number: 04

- 0014 (Appendix B, p. 95). Experiment initiated June 8,2004 and completed December 16,2004 (p. 10). Final report issued May 22,2006.

MRID 46991303. Wiedmann, J.L. Foliar dissipation of fluazinam fiom potato leaves treated Omega 500 F

2004 . SUAn published study performed by EN

- CAS Analytical Laboratories, Winston

- Salem, North- Page 114 of 137

- Carolina and Ag Consultants, Inc., New Holland, Ohio; sponsored by Ishihara Sangyo Kaisha, Ltd., Osaka, Japan; and submitted by ISK Biosciences Corporation, Concord, Ohio. ISKB Study Number: IB

- 2004

- JLW

- 002

- 0 1

- 01. EN

- CAS Study Identificatio n Number: 04

- 0013 (Appendix B, p. 94). Experiment initiated June 10,2004 and completed December 1,2004 (p. 10). Final report issued February 6,2006.



### 8 .2. Submitted Ecotoxicity Studies

MRID 42248622

. Roberts, N.; Anderson, A.; Dawe, I. (1991) Fluazinam Technical (B1216): Acute Oral Toxicity to Mallard Duck: Lab Project Number: ISN 31BT/841207. Unpublished study prepared by Huntingdon Research Centre, Ltd. and ICI, Alderley Park

- UK. 38 p.

MRID 42248623

. Hakin, B.; Johnson, A.; Anderso n, A. (1991) Fluazinam Technical (B1216): Acute Oral Toxicity to Bobwhite Quail: Lab Project Number: ISK 48/91161. Unpublished study prepared by Huntingdon Research Centre, Ltd. 33 p.

MRID 42248624

. Roberts, N.; Anderson, A.; Dawe, I. (1991) Fluazinam T echnical (B1216): The Subacute Dietary Toxicity to the Bobwhite Quail: Lab Project Number: ISN 24BT/841206. Unpublished study prepared by Huntingdon Research Centre, Ltd. and ICI, Aldferley Park

- UK. 42 p.

MRID 42248625

. Roberts, N.; Anderson, A.; Dawe, I . (1991) Fluazinam Technical (B1216): The Subacute Dietary Toxicity to Mallard Duck: Lab Project Number: ISN 25BT/841208. Unpublished study prepared by Huntingdon Research Centre, Ltd. and ICI, Alderley Park

- UK. 41 p.

MRID 44807323

. Turck, P.; Laveglia, J. (1996) Technical Fluazinam: A Reproduction Study with the Northern Bobwhite (Colinus virginianus): Phase I and II: Lab Project Number: 5512

- 92

- 0455

- TX

- 003: 272

- 116: 5512

- 92

- 0455

- TX

- 001. Unpublished study prepared by Wildlife International Ltd. 358 p.

MRID 44831907

. Turck, P.; Laveglia, J. (1996) Technical Fluazinam: A Reproduction Study with Mallard (Anas platyrhynchos): Phases I and II: Lab Project Number: 5512

- 92

- 0454

- TX

- 003: 272

- 117. Unpublished study prepared by Wildlife International Ltd. 364 p. {OPPTS 850.2300}

MRID 42208408

. Kitajima, T. (1982) Fluazinam Technical IKF1216: Acute Toxicity to the Common Carp: Lab Project Number: 112. Unpublished study prepared by Ishihara Sangyo Kaisha Ltd. Central Research Institute. 13 p.

MRID 42208409

. Hill, R. (1992) Fluazinam Technical PP192: Determination of Acute toxicity to Rainbow Trout (Salmo gairdneri): Lab Project Number: BL/B/2560. Unpublished study prepared by ICI Brixham Lab. 24 p.

MRID 42974904

. Gelin, M.; Laveglia, J. (1992) Technical Fl uazinam (IFK

- 1216)

- Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Flow

- Through Conditions: Lab Project Number: 509991

- 0422

- TX

- 002: 92

- 9

- 4409: 010190/FIFRA 72

- 1 RT. Unpublished study prepared by Ricerca, Inc and Springborn Labs, Inc. 93 p.

M RID 42974905

, Gelin, M.; Laveglia, J. (1993) Technical Fluazinam (IFK

- 1216)

- Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) Under Flow

- Through Conditions: Lab Project Number: 5099

- 91

- 0421

- TX

- 002: 92

- 11

- 4488: 12073.1091.6107.105. Unpublished stud y prepared by Ricerca, Inc., and Springborn Labs, Inc. 95 p.

MRID 42208410

. Farrelly, E.; Vincent, J.; Hamer, M.; et al. (1992) Fluazinam Technical B1216, PP192: Toxicity to First Instar Daphnia magna: Lab Project Number: RJ0392B. Unpublished study prep ared by ICI Plant Protection Division. 19 p.

MRID 42974906

. Shults, S.; Brock, A.; Laveglia, J. (1992) Acute Toxicity to Daphnids (Daphnia magna)

Under Flow

- Through Conditions with Technical Fluazinam (IFK

- 1216): Lab Project Number: 5108

- 91

-- Page 115 of 137

- 0418

- TX

- 002: 4039

- 91

- 0413

- AS

- 001: 92

- 4

- 4193. Unpublished study prepared by Ricerca, Inc., and Springborn Labs, Inc. 82 p.

MRID 44807324

. Shults, S.; Laveglia, J.; Brock, A. (1993) Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under Flow

-- Through Conditio ns with Technical Fluazinam (IKF

- 1216): Lab Project Number:

5017

- 91

- 0417

- TX

- 002: 12073

- 1091

- 6104

- 504: 051590/FIFRA 72

- 3 OY. Unpublished study prepared by Springborn Laboratories, Inc. 85 p.

MRID 44807325

. Shults, S.; Laveglia, J.; Brock, A. (1993) Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Flow

-- Through Conditions with Technical Fluazinam (IKF

- 1216): Lab Project Number: 5017

- 91

- 0415

- TX

- 002: 4039

- 91

- 0413

- AS

- 001: 92

- 9

- 4421. Unpublished study prepared by Springborn Laboratories, Inc. 86 p.

MRID 44807326

. Shults, S.; Laveglia, J.; Brock, A. (1992) Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Flow

-- Through Conditions with Technical Fluazinam (IKF

- 1216): Lab Project Number: 5017

- 91

- 0416

- TX

- 002: 12073.1091.6102.515: 92

- 9

- 4406 . Unpublished study prepared by Springborn Laboratories, Inc. 87 p.

MRID 44807327

. Fillmore, G.; Laveglia, J. (1993) Technical Fluazinam (IKF

- 1216)

-- The Toxicity to Fathead Minnow (Pimpehales promelas) During an Early Life

- Stage Exposure: Lab Project Nu mber:

5018

- 91

- 0425

- TX

- 002: 12073.1091.6105.120: 91

- 0425. Unpublished study prepared by Springborn Laboratories, Inc. 118 p.

MRID 44807328

. Shults, S.; Laveglia, J.; Brock, J. (1993) Chronic Toxicity to Daphnia magna Under

Flow

- Through Conditions with Te chnical Fluazinam (IKF

- 1216): Lab Project Number: 5109

- 91

- 0419

- TX

002: 91

- 0419: 5109

- 91

- 0419

- TX

- 000. Unpublished study prepared by Springborn Laboratories, Inc. 147 p. {OPPTS 850.1300}

MRID 45822101

. Lima, W. (2002) IKF

- 1216 Technical

-- Life

- Cycle Toxici ty Test with Mysids (Americamysis bahia): Lab Project Number: 13562. 6114: 012102/FIFRA/MYSIDLC. Unpublished study prepared by Springborn Smithers Laboratories. 74 p. {OPPTS 850.1350}

MRID 45822102

. Sousa, J. (2002) IKF

- 1216 Technical

-- Early Life

- Stage Toxicity Test with Sheepshead Minnow (Cyprinodon variegatus): Lab Project Number: 13562.6113: 022102/FIFRA/ELS

- SHM/ISHIHARA. Unpublished study prepared by Springborn Smithers Laboratories. 69 p.

MRID 44807329

. Shults, S.; Laveglia, J.; Brock, J. (1995) Technical Fluazinam (IKF

- 1216)

-- The Chronic Toxicity to the Fathead Minnow (Pimephales promelas) During a Full Life

- Cycle Exposure: Lab Project

Number: 5107

- 92

- 0035

- TX

- 002: 92

- 0035: 12073.0392.6113.122. Unpublished study prepared by Springborn Laboratories, Inc. 475 p. {OPPTS 850.1500}

MRID 44807331

. Backus, P. (1993) Effect of IKF 1216 (Fluazinam) on Seed Germination/Seedling Emergence (Tier I): Lab Project Number: 5549

- 92

- 0483

- BE

- 001: 5549

- 92

- 0483

- B E

- 000: SEED I. Unpublished study prepared by Ricerca, Inc. 65 p.

MRID 44807332

. Backus, P. (1993) Effect of IKF 1216 (Fluazinam) on Vegetative Vigor of Plants (Tier I): Lab Project Number: 5549

- 92

- 0484

- BE

- 001: 5549

- 92

- 0484

- BE

- 000: VEG I. Unpublished stu dy prepared by Ricerca, Inc. 55 p. {OPPTS 850.4150}

MRID 46172802

. Stewart, E. (2003) Tier I Vegetative Vigor Study Assessing IKF

- 1216 500F Formulation. Project Number: IB/2003/MG/002/00/00. Unpublished study prepared by Stewart Agricultural
Research Se rvices. 73 p.

MRID 46172801

. Stewart, P.; Stewart, E. (2003) Tier 1 Seedling Emergence Study Assessing IKF

- 1216 500F Formulation. Project Number: IB/2002/MG/001/00/00. Unpublished study prepared by Stewart Agricultural Research Services. 46 p.

MRID 4617 2802

. Stewart, E. (2003) Tier I Vegetative Vigor Study Assessing IKF

- 1216 500F Formulation. Project Number: IB/2003/MG/002/00/00. Unpublished study prepared by Stewart Agricultural- Page 116 of 137

- Research Services. 73 p.

MRID 44807333

. Crosby, K. (1995) Effect of IKF 1216 on Vegetative Vigor of Plants (Tier II): Lab Project

Number: 6363

- 95

- 0019

- BE

- 001: 95

- 0019: IKF 1216 VEG II. Unpublished study prepared by Ricerca, Inc. 58 p. {OPPTS 850.4250}

MRID 45822103

. Boeri, R.; Ward, T. (2001) IKF

- 1216: Toxicity to the Duckw eed, Lemna gibba: Lab Project Number: 013022: TRW

- 2129

- SK: 2129

- SK. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 34 p. {OPPTS 850.4400}

MRID 44807334

. Smyth, D.; Tapp, J. (1987) PP192(B1216): Determination of Toxicity to the Green Algae Selenastrum capricornutum: Lab Project Number: BL/B/3056: P765/A. Unpublished study prepared by Imperial Chemical Industries, PLC. 20 p. {OPPTS 850.440, 850.5400}

MRID 45822104

. Hoberg, J. (2002) IKF

- 1216 Technical

-- Acute Toxicity to the Freshwater Gre en Alga (Pseudokirchneriella subcapitata): Lab Project Number: 13562.6115: 022002/OPPTS/SA

PSS/ISHIHARA. Unpublished study prepared by Springborn Smithers Laboratories. 55 p. {OPPTS 850.5400}

MRID 45822105

. Hoberg, J. (2002) IKF

- 1216 Technical

-- Acute To xicity to the Freshwater Diatom (Navicula pelliculosa): Lab Project Number: 13562.6116: 022202/OPPTS/SA

- NAVICULA. Unpublished study prepared by Springborn Smithers Laboratories. 56 p. {OPPTS 850.5400}

MRID 45822106

. Hoberg, J. (2002) IKF

- 1216 Technical

-- Acute Toxicity to the Freshwater Blue

- Green Alga (Anabaena flos

- aquae): Lab Project Number: 13562.6117: 022002/OPPTS/SA

ANABAENA/ISHIHARA. Unpublished study prepared by Springborn Smithers Laboratories. 54 p. {OPPTS 85 0.5400}

MRID 45822107

. Hoberg, J. (2002) IKF

- 1216 Technical

-- Acute Toxicity to the Marine Diatom, Skeletonema costatum: Lab Project Number: 13562.6118: 022102/OPPTS/SA

- SKELTONEMA. Unpublished study prepared by Springborn Smithers Laboratories. 55 p. {OPPTS 850.5400}

MRID 42208 411

. Collins, I.; Gough, H.; Wilkinson, W. (1992) Fluazinam Technical B1216, PP192: Acute Contact and Oral Toxicity to Honey Bees (Aphis mellifera): Lab Project Number: RJ0401B. Unpublished study prepared by ICI Plant Protection Division. 27 p.

MRID 448 07335

. Edwards, P.; Coulson, J. (1985) B1216 (PP192): Toxicity of Technical Material to the Earthworm Eisenia foetida: Lab Project Number: RJ0409B. Unpublished study prepared by ICI Plant Protection Division. 17 p. {OPPTS 850.6200}

MRID 44807336

. Years don, H.; Burgess, A.; Coulson, J. (1991) Fluazinam: Toxicity to the Earthworm
Eisenia foetida of a 500 Gram Litre?

- 1| Suspension Concentrate Formulation: Lab Project Number:

RJ1087B.

Appendix 1 

### A ppendix A . PRZM/EXAMS Sample Input/Output Data

NC Apples

stored as Fluazinam.out

Chemical: Fluazinam PRZM environment: NCappleSTD.txt modified Tueday, 29 May 2007 at 13:58:16- Page 117 of 137

- EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at

06:14:07

Metfile: w03812.dvf modified Tueday, 26 August 2008 at 06:14:09 Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1965 7.568 6.12 3.33 2.125 2.194 0.8356

1966 30.89 24.96 13.67 7.326 5.591 1.968

1967 37.88 32.48 18.75 9.945 8.498 2.879

1968 22.54 18.95 11.85 6.229 4.878 1.989

1969 50.02 40.25 20.47 10.05 7.46 2.455

1970 8.817 7.318 5.192 2.796 2.208 1.2

1971 7.62 6.253 3.715 2.865 2.275 1.044

1972 16.89 13.73 7.057 5.235 3.994 1.677

1973 23.88 19.28 10.03 7.865 5.835 2.016

1974 21.49 17.5 9.595 4. 888 3.893 1.437

1975 12.59 10.2 5.439 3.046 2.463 1.071

1976 8.298 6.772 4.18 3.566 3.26 1.363

1977 18.18 14.77 11.26 6.052 4.895 1.976

1978 30.92 25.04 13.14 6.71 4.956 1.975

1979 6.501 5.308 3.638 2.518 2.339 1.2

1980 6.374 5.138 3.072 2.037 1.733 0.8401

1981 3.611 3.082 2.112 1.615 1.349 0.5906

1982 25.02 20.28 13.69 7.139 5.348 2.341

1983 8.244 6.754 4.408 2.654 2.127 1.06

1984 10.32 8.446 6.045 4.451 3.589 1.333

1985 31.82 25.75 13.1 6.172 4.587 1.67

1986 28.85 23.36 12.33 6.036 4.759 1.738

1987 17.84 14.54 9.673 4.561 3.596 1.794

1988 5.82 4.928 2.675 1.799 1.755 0.9816

1989 16.74 13.7 8.414 5.675 5.156 1.928

1990 38.42 31.83 16.63 9.044 7.173 2.588

Sorted results

Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly

0.037037037037037 50.02 40.25 20.47 10.05 8 .498 2.879

0.0740740740740741 38.42 32.48 18.75 9.945 7.46 2.588

0.111111111111111 37.88 31.83 16.63 9.044 7.173 2.455

0.148148148148148 31.82 25.75 13.69 7.865 5.835 2.341

0.185185185185185 30.92 25.04 13.67 7.326 5.591 2.016

0.222222222222222 30.89 24.96 13.14 7.139 5.348 1.989

0.259259259259259 28.85 23.36 13.1 6.71 5.156 1.976

0.296296296296296 25.02 20.28 12.33 6.229 4.956 1.975

0.333333333333333 23.88 19.28 11.85 6.172 4.895 1.968

0.37037037037037 22.54 18.95 11.26 6.052 4.878 1.928

0.407407407407407 21.49 17.5 10.03 6.036 4.759 1.794

0.444444444444444 18.18 14.77 9.673 5.675 4.587 1.738

0.481481481481481 17.84 14.54 9.595 5.235 3.994 1.677

0.518518518518518 16.89 13.73 8.414 4.888 3.893 1.67

0.555555555555556 16.74 13.7 7.057 4.561 3.596 1.437

0.59259 2592592593 12.59 10.2 6.045 4.451 3.589 1.363

0.62962962962963 10.32 8.446 5.439 3.566 3.26 1.333

0.666666666666667 8.817 7.318 5.192 3.046 2.463 1.2

0.703703703703704 8.298 6.772 4.408 2.865 2.339 1.2

0.740740740740741 8.244 6.754 4.18 2.796 2.275 1.071- Page 118 of 137

- 0.777777777777778 7.62 6.253 3.715 2.654 2.208 1.06

0.814814814814815 7.568 6.12 3.638 2.518 2.194 1.044

0.851851851851852 6.501 5.308 3.33 2.125 2.127 0.9816

0.888888888888889 6.374 5.138 3.072 2.037 1.755 0.8401

0.925925925925926 5.82 4.928 2.675 1.799 1 .733 0.8356

0.962962962962963 3.611 3.082 2.112 1.615 1.349 0.5906

0.1 **38.042** 32.025 **17.266 9.3143**  7.2591 2.4949
Average of yearly averages: 1.61345769230769

Inputs generated by pe5.pl

- Novemeber 2006

Data used for this run: Output File: Fluazinam

Metfile: w03812.dvf

PRZM scenario: NCappleSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Fluazinam Description Variable Name Value Units Comments Molecular weight mwt 465.1 g/mol

Henry's Law Const. henry 7.11e

- 5 atm

- m^3/mol

Vapor Pressure vapr 8.25e

- 6 torr Solubility sol 0.071 mg/L

Kd Kd mg/L

Koc Koc 1958 mg/L Photolysis half

- life kdp 4.55 days Half

- life Aerobic Aquatic Metabolism kbacw 32.01 days Halfife Anaerobic Aquatic Metabolism kbacs 0 days Halfife

Aerobic Soil Metabolism asm 254 days Halfife Hydrolysis: pH 7 50.7 days Half

- life

Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI 0.00 cm Application Rate: TAPP 0.504 kg/ha Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.03 fraction of application rate applied to pond Application Date Date 01

- 06 dd/mm or dd/mmm or dd

- mm or dd

- mmm
Interval 1 interval 7 days Set to 0 or delete line for single app.
app. rate 1 apprate 0.504 kg/ha

Interval 2 interval 7 days Set to 0 or delete line for single app.
app. rate 2 apprate 0.504 kg/ha

Interval 3 interval 7 days Set to 0 or delete line for single app.
app. rate 3 apprate 0.504 kg/ha

Interval 4 interval 7 days Set to 0 or delete line for single app.
app. rate 4 apprate 0.504 kg/ha

Interval 5 interval 7 days Set to 0 or delete line for single app.
app. rate 5 apprate 0.504 kg/ha

Interval 6 interval 7 days Set to 0 or delete line for single app.
app. rate 6 apprate 0.504 kg/ha

Interval 7 interval 7 days Set to 0 or delete line for single app.
app. rate 7 apprate 0.504 kg/ha

Inte rval 8 interval 7 days Set to 0 or delete line for single app.
app. rate 8 apprate 0.504 kg/ha

Interval 9 interval 7 days Set to 0 or delete line for single app.
app. rate 9 apprate 0.504 kg/ha

Record 17: FILTRA- Page 119 of 137

- IPSCND 1

UPTKF 0

Record 18: PLVKRT 0

PLDKRT 0

FEXTRC 0.5
Flag for Index Res. Run IR EPA Pond
Flag for runoff calc. RUNOFF none none, monthly or total(average of
entire run)



### Benth ic EECs

stored as Fluazinamben.out

Chemical: Fluazinam PRZM environment: NCappleSTD.txt modified Tueday, 29 May 2007 at 13:58:16 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at

06:14:07

Metfile: w03812.dvf modified Tueday, 26 August 2008 at 06:14:09 Benthic segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1965 1.76 1.759 1 .729 1.591 1.546 0.6677

1966 4.291 4.288 4.213 4.106 3.906 1.788

1967 6.932 6.927 6.826 6.261 5.732 2.741

1968 4.49 4.486 4.403 4.023 3.719 2.265

1969 6.228 6.223 6.146 5.749 5.323 2.4

1970 2.344 2.31 2.191 1.965 1.773 1.421

1971 1.956 1.954 1.92 1.75 1.67 1 1.096

1972 3.142 3.141 3.108 2.956 2.861 1.596

1973 5.111 5.106 5.009 4.544 4.171 2.029

1974 3.478 3.475 3.416 3.122 2.866 1.603

1975 2.16 2.159 2.133 2.018 1.886 1.043

1976 2.577 2.576 2.537 2.459 2.39 1.389

1977 4.254 4.25 4.171 3.874 3.66 1.78

1978 4.173 4.17 4.095 3.91 3.649 2.068

1979 2.144 2.124 2.018 1.767 1.727 1.37

1980 1.429 1.428 1.405 1.293 1.294 0.9311

1981 1.054 1.053 1.038 0.9843 0.9383 0.6497

1982 4.946 4.942 4.851 4.395 4.026 2.136

1983 1.891 1.86 1.738 1.71 1.648 1.158

1984 3.01 3.008 2.958 2.755 2.563 1.389

1985 4.111 4.108 4.043 3.686 3.366 1.59

1986 3.877 3.874 3.805 3.496 3.301 1.66

1987 3.627 3.624 3.561 3.234 3 1.894

1988 1.932 1.901 1.796 1.66 1.509 1.152

1989 4.174 4.17 4.095 3.821 3.642 1.792

1990 6.113 6.109 6.004 5.512 5.173 2.48

Sorted results

Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly

0.037037037037037 6.932 6.927 6.826 6.261 5.732 2.741

0.0740740740740741 6.228 6.223 6.146 5.749 5.323 2.48

0.111111111111111 6.113 6.109 6.004 5.512 5.173 2.4

0.148148148148148 5.111 5.106 5.009 4.544 4.171 2.265

0.185185185185185 4.946 4.942 4.851 4.395 4.026 2.136- Page 120 of 137

- 0.222222222222222 4.49 4.486 4.403 4.106 3.906 2.068

0.259259259259259 4.291 4.288 4.213 4.023 3.719 2.029

0.296296296296296 4.254 4.25 4.171 3.91 3.66 1.894

0.333333333333333 4. 174 4.17 4.095 3.874 3.649 1.792

0.37037037037037 4.173 4.17 4.095 3.821 3.642 1.788

0.407407407407407 4.111 4.108 4.043 3.686 3.366 1.78

0.444444444444444 3.877 3.874 3.805 3.496 3.301 1.66

0.481481481481481 3.627 3.624 3.561 3.234 3 1.603

0.518518518518518 3.478 3.475 3.416 3.122 2.866 1.596

0.555555555555556 3.142 3.141 3.108 2.956 2.861 1.59

0.592592592592593 3.01 3.008 2.958 2.755 2.563 1.421

0.62962962962963 2.577 2.576 2.537 2.459 2.39 1.389

0.666666666666667 2.344 2.31 2.191 2.018 1.8 86 1.389

0.703703703703704 2.16 2.159 2.133 1.965 1.773 1.37

0.740740740740741 2.144 2.124 2.018 1.767 1.727 1.158

0.777777777777778 1.956 1.954 1.92 1.75 1.671 1.152

0.814814814814815 1.932 1.901 1.796 1.71 1.648 1.096

0.851851851851852 1.891 1.86 1.738 1 .66 1.546 1.043

0.888888888888889 1.76 1.759 1.729 1.591 1.509 0.9311

0.925925925925926 1.429 1.428 1.405 1.293 1.294 0.6677

0.962962962962963 1.054 1.053 1.038 0.9843 0.9383 0.6497

0.1 **6.1475** 6.1432 **6.0466 5.5831**  5.218 2.424
Average of yearly averag es: 1.61878846153846

Inputs generated by pe5.pl

- Novemeber 2006

Data used for this run: Output File: Fluazinam

Metfile: w03812.dvf

PRZM scenario: NCappleSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Fluazinam Description Variable Name Value Units Comments Molecular weight mwt 465.1 g/mol

Henry's Law Const. henry 7.11e

- 5 atm

- m^3/mol

Vapor Pressure vapr 8.25e

- 6 torr Solubility sol 0.071 mg/L

Kd Kd mg/L

Koc Koc 1958 mg/L Photolysis half

- life kdp 4.55 days Half

- life Aerobic Aquatic Metabolism kbacw 32.01 days Halfife Anaerobic Aquatic Metabolism kbacs 0 days Halfife

Aerobic Soil Metabolism asm 254 days Halfife Hydrolysis: pH 7 50.7 days Half

- life

Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI 0.00 cm Application Rate: TAPP 0.50 4 kg/ha Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.03 fraction of application rate applied to pond Application Date Date 01

- 06 dd/mm or dd/mmm or dd

- mm or dd

- mmm
Interval 1 interval 7 days Set to 0 or delete line for single app.

app. r ate 1 apprate 0.504 kg/ha

Interval 2 interval 7 days Set to 0 or delete line for single app.
app. rate 2 apprate 0.504 kg/ha- Page 121 of 137

- Interval 3 interval 7 days Set to 0 or delete line for single app.
app. rate 3 apprate 0.504 kg/ha

Interval 4 interval 7 days Set t o 0 or delete line for single app.
app. rate 4 apprate 0.504 kg/ha

Interval 5 interval 7 days Set to 0 or delete line for single app.
app. rate 5 apprate 0.504 kg/ha

Interval 6 interval 7 days Set to 0 or delete line for single app.
app. rate 6 apprate 0.5 04 kg/ha

Interval 7 interval 7 days Set to 0 or delete line for single app.
app. rate 7 apprate 0.504 kg/ha

Interval 8 interval 7 days Set to 0 or delete line for single app.
app. rate 8 apprate 0.504 kg/ha

Interval 9 interval 7 days Set to 0 or delete line for single app.
app. rate 9 apprate 0.504 kg/ha

Record 17: FILTRA

IPSCND 1

UPTKF 0

Record 18: PLVKRT 0

PLDKRT 0

FEXTRC 0.5
Flag for Index Res. Run IR EPA Pond
Flag for runoff calc. RUNOFF none none, monthly or total(average of
entire run)- Page 122 of 137

- Appendix 2 

### Appendix B

. Example T

- REX (v. 1.5 .1 ) Input and Output for Fluazinam

Table B.1

. T

- REX Model Inputs: Chemical Application Scenarios and Body Mass for Assessed Species.- Page 123 of 137

- 

### Table B .2. Avian and Mammalian Toxicity Endpoints for RQ Calculation.- Page 124 of 137

- 

### Table B .3. Avian Dose

- and Dietary

- based Upper Bound Kenaga EECs and RQs Based on the Registered Use of Fluazinam on Apples

.- Page 125 of 137

- 

### Table B

. 4 . Mammalian Dose

- and Dietary

- based Upper Bound Kenaga EEC s and RQs Based on the Registered Use of Fluazinam on Citrus.- Page 126 of 137

- Appendix 3 

### Appendix C . Example Terrplant (v. 1.2.2) Input and Output for Fluazinam

Appendix 4 

### Appendix D

. STIR Results

.- Page 127 of 137

-- Page 128 of 137

- Appendix 5 

### Appendix E

. SIP Results

.

Table 1. Inputs

Parameter Value

Chemical name Fluazinam
Solubility (in water at 25 o C; mg/L) 0.071

Mammalian LD 50 (mg/kg

- bw) 4100
Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 10.6 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- bw) 1782 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) Bobwhite quail NOAEC (mg/kg

- diet) 200 NOAEC (mg/kg

- diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg

- diet) for 2nd other bird species Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.0122 0.0122 Adjusted toxicity value (mg/kg

- bw) 3153.5583 8.1531 Ratio of exposure to toxicity 0.0000 0.0015

Conclusion* Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is

NOT a potential

concern for

mammals

Table 3. Avian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.0575 0.0575 Adjusted toxicity value (mg/kg

- bw) 1283.8054 21.2597 Ratio of exposure to acute toxicity 0.0000 0.0027

Conclusion* Drinking water exposure alone is NOT a potential
concern for birds Drinking water exposure alone is

NOT a potential
concern for birds- Page 129 of 137

- Appendix 6 

### Appendix F . Classifications of Environmental Fate Studies Submitted for

Fluazinam

OCSPP

Guideline Study Type MRID Review

Classification Classification Justifications or Comments (for Supplemental and Unacceptable Studies)

835.2120 Hydrolysis 42208412 Acceptable N/A

835.2240 Aqueous photolysis 42248626 Acceptable N/A

835.2410 Soil photolysis 44807313 Acceptable N/A

835.4100 Aerobic soil

metabolism 42208413,

42208414 Acceptable 42208414 is a comparison of the foreign soils used in 42208413, to domestic soils.

835.4200 Anaerobic soil

metabolism 42208413,

42208414 Supplemental Only three sampling intervals occurred after flooding.

835.4300 Aerobic aquatic

metabolism 44807314 Supplemental The pesticide was not applied at the same time the

sediment was flooded.

835.4300 Aerobic aquatic

metabolism 48361525 Supplemental Unextracted residues totaled up to 57.9

- 59.2% AR

and other minor issues

835.4400 Anaerobic aquatic

metabolism 43521010 Acceptable N/A

835.1230 Adsorption/ desorption 42974913,

42248628 Acceptable 42974913 is a comparison of the foreign soils used

in 42248628, to domestic soils.

835.1230 Adsorption/ desorption 43528201 Acceptable Mobility study for the degradate HYPA.

835.1230 Adsorption/ desorption 44807315 Supplemental Mobility study for the degradate HYPA. Soils were

sterilized and no reference chemicals were used.

835.1240 Aged leaching 42208415 Acceptable N/A

835.6100 Terrestrial field dissipation

- CA 44807317 Supplemental Storage stability data were inadequate, analytical methods appeared to be inadequate, application rates

were not verified.

835.6100 Terrestrial field dissipation

- ND 44807318 Supplemental Storage stability data were inadequate, analytical methods appeared to be inadequate, application rates

were not verified.

835.6100 Terrestrial field dissipation

- GA 44807319 Supplemental Storage stability data were inadequate, analytical methods appeared to be inadequate, application rates

were not verified.

835.6100 Terrestrial field dissipation

- WA 44807320 Supplemental Storage stability data were inadequate, analytical methods appeared to be inadequate, total water input (rainfall plus irrigation) was insufficient.

835.6100 Terrestrial field dissipation

- GA 48361521 Supplemental Test substance applied at a high rate; the application rate was not verified using application monitoring devices; the storage stability data were inadequate

835.6100 Terrestrial field dissipation

- ND 48361522 Supplemental Test substance applied at a high rate and minimum retreatment interval was not used; the application rate was not verified using application monitoring devices; the storage stability data were inadequate;

grass clippings were removed from the plot from the first to the fourth application- Page 130 of 137

- OCSPP

Guideline Study Type MRID Review

Classification Classification Justifications or Comments (for Supplemental and Unacceptable Studies)

835.6100 Terrestrial field dissipation

- CA 48361523 Supplemental Test substance applied at a high rate; the application rate was not verified using application monitoring devices; the storage stability data were inadequate; the plot history was not provided

835.6100 Storage stability 44807316 Supplemental Storage stability was inadequate for some of the analytes.

835.6100 Storage stability 48361518 Supplemental Storage stability was inadequate for some of the analytes.

850.1730 Fish BCF 43521012 Acceptable N/A

850.6100 Analytical method

in soil for fluazinam and three degradates 48361519 Unacceptable An ILV was not provided, performance data were outside acceptable limits (70

- 120%) at the LOQ for fluazinam and MAPA, only duplicates were analyzed, and samples were not measured at 10 LOQ.

850.6100 Analytical method

in soil for fluazinam

and HYPA 48632401 Supplemental (upgradeable)

1 For the ECM, incomplete data were provided, performance, LOD, chromatograms of standards and method and matrix blank samples, calibration curves and linear regression analyses, results from the confirmatory method, and the source and

characterization of the soil matrix were not provided.

F or the ILV, acceptance criteria were not met for one of the five fortifications for HYPA; quantitative results from the confirmatory method were not reported and data on the representative chromatograms were illegible; the soil matrix was

not characterized

.

850.6100 Analytical method

in soil and sediment

for AMPA and

DAPA 48361520 Unacceptable An ILV was not provided, for AMPA & DAPA some results from the fortified samples were not reported due to poor recoveries, and data were outside the acceptable limits of 70

- 120%.

850.6100 Analytical method

in sediment for

fluazinam 48632402 Supplemental (upgradeable)

1 For the ECM, incomplete data were provided, performance data, LOD, chromatograms of standards and method and matrix blank samples, calibration curves and linear regression analyses, results from the confirmatory method, and the

source and characterization of the sediment matrix were not provided; quantitative results from the confirmatory method were not reported and data on the representative chromatogram were illegible.- Page 131 of 137

- OCSPP

Guideline Study Type MRID Review

Classification Classification Justifications or Comments (for Supplemental and Unacceptable Studies)

850.6100 Analytical method

in sediment for the degradates AMPA

and DAPA 48635801 Supplemental (cannot be upgraded) For the ECM, RSDs for AMPA and DAPA in sediment at the LOQ and DAPA in soil at 100 x LOQ were not within acceptance criteria, no RSDs were provided at 10 x LOQ for either analyte, individual recovery results and the number of samples analyzed at each fortification level and for each matrix were not reported, chromatograms of standards and method and matrix blank samples, calibration curves and linear regression analyses were not provided, characterization of the sediment

ma trix was not provided. For the ILV, the method was not validated using a soil matrix, in addition to the sediment, for both analytes at the LOQ, two of the five fortifications were not within acceptance criteria, and for DAPA

the RSD exceeded 20%.

For both the ECM and ILV, a confirmatory method was not performed, during conduct of the ECM, DAPA was found to “degrade over time in the extracts”; however, additional information was not provided.

850.6100 Analytical method

in water for

fluazinam 48361524 Unacceptable An ILV was not provided, extraction solvent (methylene chloride) was combined with untreated

water prior to fortification with the test substance.

850.6100 Analytical method

in water for

fluazinam and five degradates 48635802 Supplemental (upgradeable)

1 For the ECM, performance data were incomplete. Only results from one water sample fortified at the LOQ with all six compounds were reported, chromatograms of standards and method and matrix blank samples were not provided, calibration curve s and linear regression analyses were not provided, results from the confirmatory method were not reported, and the source and characterization of the water matrix were not reported. For the ILV, acceptance criteria were met for all analytes, except for t wo of the five fortifications for HYPA at the LOQ, quantitative results from the confirmatory method were not reported and data on the representative chromatograms were illegible, and the tap water matrix was not further

characterized. To satisfy this requ irement, a method for the analysis of AMPA in water is also needed

.

Non

guideline Runoff from the

Field 44807330 Supplemental The infiltration rates exceeded the rainfall intensity of the simulated rainfall, suggesting that the soil may have absorbed the rainfall. The buffer was only 10 ft wide while the label required 25 ft.- Page 132 of 137

- OCSPP

Guideline Study Type MRID Review

Classification Classification Justifications or Comments (for Supplemental and Unacceptable Studies)

Non

guideline Foliar dissipation 46991302 Supplemental Field spikes were not performed. Residues were measurable or detectable in control samples. QC fortification samples were not corrected for control before determining recoveries. Several concurrent recovery samples were invalidated. Fortified and field samples were injected several times

Non

guideline Foliar dissipation 46991303 Supplemental Field spikes were not performed. Residues were measurable or detectable in control samples. QC fortification samples were not corrected for control before determining recoveries. Several concurrent recovery samples were invalidated. Fortified and field samples were injected several times
N/A = Not applicable- Page 133 of 137

- Appendix 7 

### Appendix G . Classifications of Ecological Effects Studies Cited in the Risk

Assessment for Fluazinam

Guideline

Subdivision J

(OCSPP) Data Requirement MRID Classification Classification Justification (for Supplemental or Unacceptable Studies)

7 1

- 1

(850.2100) Avian Acute Oral 42248622

42248623

48571409 Acceptable Acceptable Acceptable NA

7 1

- 2

(850.2200) A vian Sub

- acute Dietary 42248624

42248625 Acceptable Acceptable NA

71

- 4

(850.2300) Avian Reproduction 44807323

44831907 Acceptable Acceptable NA

7 2

- 1

(850.1075) Freshwater Fish

– Acute Toxicity 42208409

42974904

42974905 Acceptable Acceptable Acceptable NA

7 2

- 2

(850.1010) Freshwater Invertebrate

– Acute Toxicity 42208410

00159915

48571412 Supplemental Acceptable Supplemental MRID 42208410: Absence of negative control (only solvent control was used)

MRID 48571412: Nominal test

concentrations declined 10 to 59%

by study termination (48 hours)

7 2

- 3

(850.1075) Estuarine/Marine Fish

– Acute Toxicity 44807325 Acceptable NA

72

- 3

(850.1025) (850.1035) Estuarine/Marine

Invertebrate

– Acute Toxicity 44807324

44807326 Acceptable Acceptable NA

7 2

- 4

(850.1300) Freshwater Invertebrate

– Life Cycle Test 44807328 Acceptable NA

72

- 4

(850.1350) Estuarine/Marine

Invertebrate

– Life Cycle Test 45822101 Acceptable NA

72

- 4

(850.1400) Freshwater Fish

– Early Life Stage Test 44807327 Acceptable NA

72

- 4

(850.1400) Estuarine/Marine Fish

– Early Life Stage Test 45822102,

48571408 Acceptable NA

72

- 5

(850.1500) Fish

– Full Life Cycle

Test 44807329 Acceptable NA

12 3

- 1a

(850.4225) Terrestrial Plant Toxicity

– Seedling Emergence, Tier I 46172801 Acceptable NA

123

- 1b

(850.4250) Terrestrial Plant Toxicity

– Vegetative Vigor, Tiers I and II 46172801

48708701 Acceptable Acceptable NA

123

- 2

(850.4400) Vascular Aquatic Plant Toxicity, Tiers I and II Not submitted Not submitted NA

123

- 2

(850.5400) Algal Toxicity Test,

Tiers I and II 44807334

45822106

48612301 Supplemental Acceptable Acceptable MRID 44807334: Higher than guideline recommended light intensity used- Page 134 of 137

- Guideline

Subdivision J

(OCSPP) Data Requirement MRID Classification Classification Justification (for Supplemental or Unacceptable Studies)

141

- 1

(850.3020) Honeybee acute contact

and oral toxicity 42208411 Acceptable Acceptable NA

850.1735 Whole sediment acute toxicity invertebrates,

freshwater 48571413 Acceptable NA

850.1735 Whole sediment acute toxicity invertebrates,

freshwater 48571414 Acceptable NA- Page 135 of 137

- 

### Appendix 8 Appendix H. KABAM Output- Page 136 of 137

-- Page 137 of 137

-