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 

Justin 

L. 

Housenger, 

Melendez, 

Biologist 

Chemist K 

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 D411177

June 4, 2013

Prepared by

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

O2N

O2N 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. Exposure 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 transformations 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

Appendix 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

The preliminary risk assessment (PRA) examines the potential ecological 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 organisms.

 

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 exceeds 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 effects are seen across generations. Some 

uses of fluazinam may result in chronic risk to mammals and acute and chronic 

risks to birds, reptiles, and terrestrial-phase amphibians exposed to fluazinam in 

the diet. 

Expected 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 or algistatic effects in 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 KOC) has a relatively high propensity to bind to 

sediments. 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 mammals 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 depurate 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 fluazinam, as shown in the 

two approved labels for this chemical (EPA Reg. Nos. 71512-1 and 71512-20). The problem 

formulation sets the objectives for the risk assessment and provides a plan for analyzing the data 

and characterizing the risk (USEPA 1998a). 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-2009-0039] in September 2009. The following section 

summarizes the key points of that 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 conducted as part of the Agency’s Registration Review process for 

pesticide active ingredients. The Registration Review process was established under the Food 

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- (trifluoromethyl)-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 fungicide. 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-dinitroanilines 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/deprotonation (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 fluazinam is provided in Table 2.1. Table 3.4 lists chemical names and 

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

environmental fate studies. 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 

(QSARs) of these chemicals, by means of the Ecological Structure 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 04/25/2013), 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). All 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 occurrence of degradation products (see 

Section 3.2.1.4). 

Table 2.1. Chemical Profile of Fluazinam.

Property Value Reference

and Comments

Chemical Structure Product Chemistry

Pesticide type Fungicide

Product Chemistry

Chemical class Pyridine (dinitroaniline)

Molecular Formula C13H4Cl2F6N4O4

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,αtrifluoro-2,6-dinitro-p- toluidine

Water Solubility 0.025 mg/L at pH 5.5 and 25o

C MRID 42208403 0.071 mg/L at pH 7.0 and 25o

C

Vapor pressure

8.25x10-6 torr at 25oC

[Volatility lies between ‘Non-volatile under field 

conditions’ to ‘Intermediate to high volatility under field 

conditions’ (from dry non-adsorbing surfaces), (1)]

MRID 42208403

Henry’s Law Constant 7.11x10-5 atm-m3/mol; at pH 7 Calculated from WS and VP

Octanol/Water Partition 3620, (log KOW = 3.56); at 20°C MRID 42248403

Air-water partition 

coefficient (KAW)

KAW = Cair/Cwater =

Henry's Law Constant/(RT) = 2.91x10-3 (unitless)

[Classified as ‘Volatile from a water surface’ (1)]

Calculated

R=8.205746x10-5 atm-m3/

K-mole; assumed T=298K)

Octanol-air partition 

coefficient (KOA) KOA = KOW/KAW = 1.25x106 (unitless) Calculated

Cwater+soil/Cair

Cwater+soil/Cair = (Cwater/Cair)(1/r + Kd) =

(343.6) (1/6 + 29.9) = 1.03x104

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

Calculated

N

F

F

F

Cl

N

H

O2N

O2N Cl

F

F

F
-Page 7 of 137-

Property Value Reference

and Comments

UV/Vis Absorption At pH 7, λmax 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_reregistration_work

group/esa_reporting_fate.htm#I (accessed 03/26/2013).

(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 crops 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 beans, 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 general, 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 season 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 1998). Consistent 

with the process described in the Overview Document (USEPA 2004), this risk assessment uses 

a surrogate species approach in its evaluation of fluazinam. Toxicity data generated from 

surrogate test species, which are intended to be representative of broad taxonomic groups, are 

used to extrapolate potential effects on a variety of species (receptors) included under these 

taxonomic groupings. 

Acute and chronic toxicity data from studies submitted by pesticide registrants 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 evaluate

potential ecological effects of pesticides to these non-target taxonomic groups. The table also 

provides a summary of the acute toxicity classifications of fluazinam for each described taxon; 

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 parent 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)

Birds2

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 fish3

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 plants4

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 classified5

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) indicate 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. In 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 include water bodies adjacent to or downstream from the 

treated area and may include natural or impounded lentic systems such as ponds, lakes and 

reservoirs, and lotic (flowing) waterways, 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 

habitat includes estuarine and marine ecosystems. Within water bodies, the water column, 

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

2.4. Assessment Endpoints 

Assessment endpoints represent the actual environmental values that are to be protected, defined 

by ecological entities (species, community, etc.) and their attributes 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. (See Table 2.3 in Section 2.6.2, the Analysis 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 risks 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 receptors, 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 

assessment endpoints. 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 risks associated with the foliar uses of 

fluazinam relies on previous 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). Previous risk assessments (DP Barcodes: 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 nonlisted species of aquatic fish and invertebrates. This assessment tests the hypothesis that, 

when 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 routes of exposure and effects; dashed lines 

depict potential routes of exposure that are not considered likely for fluazinam. The application 

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, and 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 from the site of application The conceptual framework for assessment of potential 

ecological risk associated with fluazinam use is depicted in Figure 2.1; potential endpoints, 

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. Surface 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 in 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) and/ 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 cases, 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 KOW (log KOW = 3.56) and the chemical’s TTR may be 

persistent in water and sediments under certain circumstances, there is a potential 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). 

Bioaccumulation will be assessed using the results from bioaccumulation in fish studies, as well 

as the KOW (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 direct 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 this assessment does not evaluate potential atmospheric transport in 

estimating environmental concentrations. Similarly, the Screening Imbibition Program (SIP, 

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

Additionally, this ecological risk assessment 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 Uses 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

Route

Ingestion Direct Contact

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 Population:

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 

Measures 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 shells pe5 

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

2007), to generate estimated environmental concentrations (EECs) of fluazinam that may occur 

from use on adjacent 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 assessment, mean concentrations over 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 (Terrestrial Residue 

EXposure model; v. 1.5; March 22, 20122

) 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. Willis and McDowell 1987). Estimated exposures of 

terrestrial insects 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 used to derive EECs relevant to terrestrial 

and wetland plants for the proposed new uses 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 Screening Tool for Inhalation Risk (STIR v.1.0, November 19, 2010) was used to calculate 

an upper bound estimate of exposure 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-

inhalation 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 LD50 = 4100 mg/kg bw, MRID 42248603; and

rat inhalation LC50 0.463 mg/L, MRID 42270601, respectively) as well as the most sensitive 

acute oral avian toxicity endpoint (bobwhite quail LD50 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 

through 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 potentially 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 Screening Imbibition Program (SIP v.1.0, released 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 about 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.

Bioaccumulation will be assessed using the results from bioaccumulation in fish studies, as well 

as the KABAM model (KOW (based) Aquatic BioAccumulation Model, version 1.0, 2009), 

adjusting for biotransformation rates. 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.
-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. The ECOTOXicology database (ECOTOX), was searched in March 2013 to identify 

whether additional, more sensitive ecological effects data were available for fluazinam; however, 

no more useful data were identified (USEPA 2012).

The acute measures of effect used in this screening-level assessment are the LD50 (Lethal Dose), 

LC50 (Lethal Concentration), EC50 (Effects Concentration), and IC50 (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 Effects 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. The 

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 guidelines but the results were 

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 measured toxicity values. The RQ 

method involves dividing EECs by point estimates of the most sensitive acute and chronic 

toxicity values. The resulting RQs are then compared to the Agency’s Levels of Concern (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 effects 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/LC501 0.5

Acute 

Restricted Use

Potential for effects to animals from acute exposures

Risks may be mitigated through restricted use classification Peak EEC/LC501 0.1

Acute Listed 

Species

Listed species may be potentially affected by acute 

exposures

Peak EEC/LC501 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/LC501 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/LC50 (Dietary) 0.5

EEC/LD50 (Dose)

Acute 

Restricted Use

Potential for effects to animals from acute exposures

Risks may be mitigated through restricted use classification

EEC/LC50 (Dietary) 0.2

EEC/LD50 (Dose)

Acute Listed 

Species

Listed species may be potentially affected by acute 

exposures

EEC/LC50 (Dietary) 0.1

EEC/LD50 (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/ EC25 1

Listed Plant Potential for effects to non-target, listed plants from 

exposures

EEC/ NOAEC

1

EEC/ EC05

1 LC50 or EC50. 2 EEC based on upper bound Kenaga 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 acute 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 doseresponse relationship. In addition to a single effects probability estimate based on the mean, 

upper 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 upper bounds of 2 to 9) is used

(Urban and Cook 1986). 

Individual effect probabilities are calculated based on an Microsoft Excel spreadsheet tool IEC

v1.1 (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 individual 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 information is presented in Table 3.1. The products containing fluazinam 

are Omega® 500F Agricultural Fungicide (EPA Reg. No. 71512-1) and Fluazinam Turf (EPA 

Reg. No. 71512-20). They are flowable products containing 40.0% fluazinam. The first product 

is approved for uses such as potatoes, peanuts, bushberries, 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, traveling gun, solid set or portable3 irrigation 

systems); however, it can also be soil incorporated 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 equipment within 

150 ft of permanent estuarine/marine water bodies. For freshwater bodies of water, 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]

[Soil 

incorporation

1.36 lb] B

1 2.01 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

0.652

6 (at the 

max 

rate)

3.91 7-10 Ground C 30

Carrots 0.521 4 2.09

1st app at 

14 days; 

subsequent

apps at 7

days

Ground D 7

Ginseng 0.521-

0.782 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

0.261-

0.443 2 0.912 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 

lablab 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)

0.521 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.

0.782 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-

0.782 6 4.69 7-14 Foliar E, F 30

Peanut 0.521-

0.782

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 0.179-

0.261 7 1.82 7-10

Ground or 

Aerial, 

Sprinkler 

irrigation

14

Soybeans 0.391-

0.521 2 1.04 10-14 Ground or Aerial H NS

Turf grasses only on 

golf courses (tees, 

greens, fairways and 

roughs)

0.700 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 requiring 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 water/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. May be applied through sprinkler system irrigation 

equipment. F. The 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.

Fluazinam may be applied through sprinkler irrigation (through center pivot, motorized lateral 

move, traveling gun, solid set or portable4 irrigation systems); however, it can also be soil 

incorporated before transplant, for Crop Group 5, brassica (cole) leafy vegetables, in soils with 

low infiltration rates. The products contain 4.17 lb A.I. per gallon and are formulated as 

flowable fungicides. 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 statements (the 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 

areas 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 and 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 and 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 Management

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 products) 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 through:

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 Usage Analysis (SLUA) provided by the Biological and 

Economic Analysis Division (BEAD) in October 2011 (Table 3.2).

Table 3.2. Estimates of Agricultural Usage 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 Research

California DPR (Department of Pesticide Regulation)

3.2. Exposure Characterization

3.2.1. Environmental Fate and Transport Characterization

Environmental fate characteristics of the parent compound fluazinam are listed in Tables 3.3a 

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 3.3a. Summary of Environmental Fate Properties of Fluazinam Related to 

Degradation and Metabolism

Study

System Name/ 

Characteristics

Value (Kinetic Model1

if Applicable)

Half-life Value 

Used to Derive 

Model Input 

Parameters2

Reference, 

Study Classification*

and Comments DT50 (days) DT90 (days)

Abiotic 

Hydrolysis

pH 5, 220C Stable Stable MRID 42208412 (A)

CAPA is excluded from

the TTR.

pH 7, 220C 50.7 (SFO) 168 (SFO) SFO DT50 =

50.7 days

pH 9, 220C 5.6 (SFO)

Atmospheric 

Degradation3 Hydroxyl radical 3 163(estimated)

Estimated using EPI 

Suite v.4.1

Direct 

Aqueous 

Photolysis

pH 5, 250C 2.17 (SFO) 7.2 (SFO) MRID 44807312, 

43521009, 45584204 

(A)

Dark control stable.

TTR pH 5, 250C 4.554 (SFO) 15.14 (SFO) SFO DT50 =

4.55 days 4
-Page 23 of 137-

Study

System Name/ 

Characteristics

Value (Kinetic Model1

if Applicable)

Half-life Value 

Used to Derive 

Model Input 

Parameters2

Reference, 

Study Classification*

and Comments DT50 (days) DT90 (days)

Soil Photolysis

Loamy sand from 

Ohio, pH 7.0, 2.2% 

OM, 250C

Light exp. Dark control Photolytic t1/2: MRID 44807313, 

45584204 (A);

Results 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, 200C

45.94 (DFOP) 4814 (DFOP) Slow t1/2 (DFOP) = 

189 days 4 MRID 42208413, 

42208414 (A);

HYPA is excluded from 

the TTRs.

Parent only: ‘18 Acre’ 

152 days (DFOP slow 

t1/2); Frensham 221 days

(SFO)

Frensham loamy 

sand, pH 6.4, 1.7% 

OM, 200C

2214 (SFO) 7344 (SFO) SFO DT50 =

221 days 4

Input value for 

modeling in PRZM/ 

EXAMS from the 

two above 

mentioned systems

Represents the 90th 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, t90,n1 = 3.078).

n

t s t t 90,n-1

input = 1/2 +

= 254 days4

Anaerobic Soil 

Metabolism

’18 Acre” sandy 

loam, pH 6.9, 4.4% 

OM, 200C

4 days for 

parent only 

(flooded at 0 

days) MRID 42208413, 

32 days for 42208414 (S)

parent only

(flooded at 

30 days)

Aerobic 

Aquatic

Grand River/ loamy 

sand sediment; pH 

7.4, 0.59% OM; 

250C

5.294

(DFOP)

81.04

(DFOP)

Slow t1/2 (DFOP) = 

32.64 days at 

250C

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 tIORE = 

8.33 days

Stream water/ loamy 

sand sediment 

(Virginia Water): 

pH 6.1-6.6, 5.8% 

OM; 200C

5.914

(IORE)

54.9 4

(IORE)

tIORE = 16.54 days

at 200C

[tIORE corrected 

for temperature at 

250C is 11.7

days]

Water/sandy loam 

(Emperor Lake); pH 

5.1-5.8; 7.5% OM; 

200C

6.63 4

(IORE)

70.7 4

(IORE)

tIORE = 21.34 days 

at 200C

[tIORE corrected 

for temperature at

250C is 15.1 

days]
-Page 24 of 137-

Study

System Name/ 

Characteristics

Value (Kinetic Model1

if Applicable)

Half-life Value 

Used to Derive 

Model Input 

Parameters2

Reference, 

Study Classification*

and Comments DT50 (days) DT90 (days)

Input value for 

modeling with 

PRZM/EXAMS, at 

250C. from the three

above mentioned 

systems

Represents the 90th percentile 

of the upper confidence 

bound on the mean of three 

half-life values corrected at 

250C (32.6, 11.7, and 15.1 

days): mean 19.8 days; std. 

dev. 11.21472 days; n=3, t90,n1 = 1.886

n

t s t t 90,n-1

input = 1/2 +

=

32.01 days (at 

250C)*

Anaerobic 

Aquatic

Lake Mendota 

sediment (WI); sand, 

pH 7.6, 0.39% OM, 

250C

~0.33 days –

parent only MRID 43521010 (A)

Stable 4 Stable 4 Stable 4

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

 Bolded values represent input values in the aquatic modeling in PRZM/EXAMS.

1 DT50 and DT90 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 DT50 and DT90 are reported 

when available. Otherwise, a first and second DT50 are reported. The equations can be found in the document, 

Standard Operating Procedure for Using the NAFTA Guidance to Calculate Representative Half-life Values and 

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 DT50, tIORE, or the 2nd DT50 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 DT50 and DT90 results.

3. Estimated value. Given that the persistence in air is high, the reaction is expected to be negligible, compared to 

other processes of dissipation. 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. Values 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 3.4b. Summary of Environmental Fate Properties of Fluazinam Related to Mobility, 

Field Dissipation and Fish BCF

Study

System Name/ 

Characteristics Value (units if applicable)

Reference, 

Study Classification*

and Comments

Mobility for 

Fluazinam

Soil\Property Kd (mL/g) KOC (mL/gOC)

MRID 42248628, 

42974913 (A);

KOC model describes 

the mobility better than 

the Kd model. For KOC

the coefficient of 

variation is smaller than 

for Kd.

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/kgOC

Slightly mobile1

For same 4 soils Kd, des=34-507; KOC, 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 applicable)

Reference, 

Study Classification*

and Comments

Mobility of 

HYPA 6 sterile soils Kd=6.6-51 mL/g; KOC=640-3200 mL/g-OC;KF=4.3-26; KFOC=450-1700 MRID 43528201 (A)

Mobility of 

CAPA

4 domestic sterile 

soils

Increasing adsorption w. increasing pH

Kd=4.53-74.9 mL/g; KOC=1280-4230 mL/g-OC;

KF=4.9-67 KFOC=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

DT50~9 days loamy sand, pinto beans;

DT50=49 days, sandy loam, beans

DT50=20 days, loamy sand, beans

DT50=17 days, sandy loam, peanuts.+

+Degradation was biphasic and data was variable

in this site.

MRID 44807318, 

44807320, 44807316; 

48361521, 48361522, 

Montezuma, GA 48361523 (S) 28.1 days (DFOP slow t1/2) for thatch

13.7 days (DFOP slow t1/2) for soil2

Northwood, ND 117 days (SFO) for thatch

578 (tR IORE) for soil2

Porterville, CA 1.95 days ((tR IORE) for turfgrass

35.5 days (SFO) soil2

Special Runoff 

Study

Dinwiddie County, 

VA

Three sandy loam plots planted to peanut had 10 x 

23 ft. untreated grass buffer located downslope:

Reduction 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 t1/2 = 5.0-6.0 days was reported.

MRID 43521012 (A)

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

 Bolded values represent input values in the aquatic modeling 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.

Fluazinam 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 fluazinam 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 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 backbone 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 crop), 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 DT50s of decay of 

parent and of the parent plus certain metabolites.

3.6.1.1. Transport 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-m3/mol at pH 7). Fluazinam shows a moderately high 

octanol/water partition coefficient (log KOW = 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 believes that the parent compound would not volatilize substantially.

In batch equilibrium studies, KOC values ranged from 1,705-2,316 mL/gOC. Based upon these 

values, fluazinam is categorized as slightly mobile in four soils (FAO 2000). While these KOCs 

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 at 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 DT50s 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 other unidentified products. The DT50 obtained in the study was 2.17 days. 

The soil photolysis, on the other hand, the DT50 was ~22 days (compared to ~69 days for the 

dark control). The dark control corrected DT50 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 slow t1/2). 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 14C-Pyridyl and 

14C-Phenyl labels, respectively; no major metabolites were observed. The sandy loam treated at 

5 kg/ha yielded a DT50 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 DT50 of 221 days 

(SFO) with no major metabolites. No major degradation products were observed in the 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 DT50s

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 residues) decreases much more slowly than the parent alone, under 

both aerobic (DT50s 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 in a storage stability study. In general, it appeared that 

parent fluazinam dissipated moderately rapidly in studies conducted in Ephrata, Washington, 

Kempton, North Dakota, Porterville, California, and Montezuma, Georgia. The dissipation halflives ranged 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, Georgia (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-lives of 28.1 days (DFOP slow t1/2), 117 days (SFO t1/2) and 1.95 

days (tR IORE), in GA, ND and CA, respectively. Furthermore, fluazinam dissipated in the soil (0-

15 cm depth) with calculated non-linear half-lives of 13.7 days (DFOP slow t1/2), 578 days (tR 

IORE), and 35.5 days (SFO t1/2), 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 whole fish, and 1850 L/kg for viscera, all of which were 

obtained with the [

14C]-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 the transformation 

products of fluazinam: HYPA and CAPA. Of them, HYPA appeared to be moderately to 

slightly mobile (KOC=450-1700, 6 soils), and CAPA appeared to be slightly mobile, but 
-Page 28 of 137-

generally less mobile than the parent (KOC=1,289-3,784 in 4 soils). However, the 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 Fluazinam

Common Name

(Lab Studies ID’d*)

Chemical Name

SMILES Code Structure

Fluazinam

(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-trifluoro2,6-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-N4

-(3-chloro-5-trifluoromethyl-2-

pyridyl)-α,α,α-trifluorotoluene-3,5,5-

triamine; 3-chloro-2(2,6-diamino-3-chloroα,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-nitrop-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-N4

-(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-ocresol

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-ptoluidino-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 2005) coupled with the input shell pe5.pl (August, 2007) or EXAMSPRZM 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 its 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-meter depth 

(the “standard pond”), into which a 10-hectare cropped field drains (USEPA 2009a).

Given the high aquatic toxicity of fluazinam to freshwater invertebrates, and its likelihood to 

occur in sediment, the Agency will also consider the potential exposures resulting from benthic 

(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 2009b). Based on EFED guidance, aerial 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 the registered uses for fluazinam, a variety of locations and PRZM

crop scenarios were 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 Represented/

PRZM Crop Scenarios

Method of 

App.

Drift/

App 

Efficiency

Single 

App 

Rate

(lb 

a.i./A)

Max 

No. 

of 

Apps 

at 

Max 

Rate

Min. 

Interval 

Between 

Apps 

(days)

Day of 

App 

(daymonth)

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

Soil 

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

1st 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 Represented/

PRZM Crop Scenarios

Method of 

App.

Drift/

App 

Efficiency

Single 

App 

Rate

(lb 

a.i./A)

Max 

No. 

of 

Apps 

at 

Max 

Rate

Min. 

Interval 

Between 

Apps 

(days)

Day of 

App 

(daymonth)

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

Ecological Exposure Assessment

Fate Property Value1 (unit) Source/Comment

Molecular Weight 465.1 g/mol Product Chemistry

Henry’s constant 7.11 x 10-5 atm-m3/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 Halflives n

t s t t 90,n-1

input = 1/2 +

=

254 days

MRID 42208413, 42208414; Represents the 90th

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, t90,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

t s t t 90,n-1

input = 1/2 +

=

32.01 days

MRID 44807314, 48361525; Represents the 90th

percentile of the upper confidence bound on the 

mean of three half-life values (32.6, 16.5, 21.3 days; 

however, at 250C the corrected half-lives are 32.6, 

11.7, and 15.1 days): Mean 19.8 days; Std. Dev. 

11.21472 days; n=3, t90,n-1 = 1.886

Anaerobic Aquatic Metabolism 

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

Fate Property Value1 (unit) Source/Comment

Organic-carbon water partition 

coefficient (KOC) 1958 L/kg-OC

MRID 42248628, 42974913; Represents the average 

KOC value among four values ranging from 1705 to 

2316 ml/g-OC; the KOC 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

concentrations 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/kgoc)

21-day

average 

EEC

(μg/kgoc)

Apples/ NC 

apple Airblast 0.45 01-06 10 7 38.0 17.3 9.31 6.15 6.05 12100 11900

OR apple Airblast 0.45 15-06 10 7 12.8 6.03 4.04 2.92 2.80 5750 5510

PA apple Airblast 0.45 15-06 10 7 32.8 13.2 6.43 5.27 5.19 10370 10210

Brassica 

(Cole) Leafy 

Veg. CG 5, 

plus Turnip 

Greens/ CA 

cole crops

Soil 

drench 

after 

transplant

2.01 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 

incorporp. 

(15 cm)

1.36 09-10 1 N/A 1.54 0.610 0.327 0.214 0.209 421 411

Bushberry 

Crop SG

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 1st 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/kgoc)

21-day

average 

EEC

(μg/kgoc)

*Crop SG

6A, except 

peas; *SG

6B; *SG 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 SG 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 SG

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 SG

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/kgoc)

21-day

average 

EEC

(μg/kgoc)

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) program5. 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 

Department of Pesticide Regulation’s (CDPR6) 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 

emphasizing 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 exposures 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. Dose-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 App 

Rate

(lb a.i./A)

Max No. of 

Apps at Max 

Rate

Min. Interval 

Between Apps 

(days)

Apple 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 1st 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 App 

Rate

(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 uncertainties 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 insufficient. 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 dissipation 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 Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 (TREX 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 Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 29 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  Herbivores and Omnivores Insectivores Granivores

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

Dietary Items 

Short Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 Fluazinam

(T-REX v. 1.5.1).

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 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 labeled 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 

semiaquatic 

areas

Spray 

drift

Total 

for dry 

areas

Total for 

semiaquatic 

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 (KOW (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 KABAM 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 partition coefficient (KOW) 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 tissue 

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, zooplankton, 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 Fluazinam

Log KOW 3.56 MRID 42248403

KOC 1958 L/kgOC MRIDs 02248628, 42974913

Highest Exposure Scenario Modeled

Use patterns Fruiting vegetables (PA tomato scenario)

(foliar, 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 fluazinam 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 upon registrant-submitted toxicity 

data for the TGAI (parent compound) and for specified formulations. Appendix G lists these 

studies, their review classifications, and associated deficiencies. The ecotoxicity data for

fluazinam and its associated products 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 plants, 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 section. 
-Page 46 of 137-

The results of a 2012 review of the Ecological Incident Information System (EIIS) are described 

in Section 3.3.3 (USEPA 2012). 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 3.21 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 toxic to freshwater 

invertebrates and estuarine/marine 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 LC50

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 

LC50 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 lowest 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 concentrations 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 

macrochirus, 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 LC50 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 47 of 137-

Table 3.8. Summary of Acute Toxicity Data for Freshwater Fish Exposed to Fluazinam

Species Study Type Test Substance 

(Purity)

LC50

(μg a.i/L)1,2,3

(95% CL;

slope)

Toxicity Classification 

(MRID)

Rainbow trout 

(Oncorhynchus mykiss)

96-hour, flowthrough TGAI (97.4%)

130

(100 – 180; 

N/A)

Highly toxic

(42208409)

96-hour, flowthrough TGAI (96.8%)

36

(28 – 56; 

N/A)

Very highly toxic

(42974904)

Bluegill sunfish (Lepomis 

macrochirus)

96-hr, flowthrough TGAI (96.8%)

52.7

(47.1 – 59.9; 

N/A)

Very highly toxic

(42974905)

CL: Confidence limits. LC50: 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 probit 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 negative 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 full 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 F0 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 negative 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 concentrations.

For the F1 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 F0 fish included scoliosis, cranial 

malformations, and protruding eyes. These effects occurred in the lowest and two highest 
-Page 48 of 137-

treatment concentrations. There was one fish in the F1 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 F1 hatching success. This study is classified as acceptable. 

Table 3.9. Summary of Chronic Toxicity Data for Freshwater Fish Exposed to Fluazinam

Species Study Type Test Substance (Purity)

NOAEC;

LOAEC

(μg a.i/L) 1,2

Endpoints

(MRID)

Fathead minnow 

Pimephales 

promelas

32-d Early 

Life Stage TGAI (96.8%) 5.3; 10 Larval survival

(44807327)

278-d Full 

Life Cycle TGAI (96.8%) 0.69; 1.4

F1 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 acute toxicity tests available for the freshwater invertebrate Daphnia magna

(Table 3.17). In a static study (MRID 42208410), the EC50 was determined to be 180 μg a.i/L. 

Although sublethal effects were noted to occur at all test concentrations during the study, 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 EC50 was determined to be 222 μg a.i/L and this study was classified 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 determination of endpoints. The LC50 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 purposes.

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 cycle 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<0.05) 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 the 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)

EC50

(μg 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, flowthrough TGAI (96.8%) 222

(188 – 300; 2.8)

Highly toxic

(00159915)

Freshwater midge

Chironomus 

riparius

48-hr, static TGAI (97.8%)

62.63

(251.9 – 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 being 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

(μg 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 solvent 

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. Sublethal effects included loss of 

equilibrium and was observed at the 240 μg a.i/L treatment concentration. The LC50 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 fluazinam 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 determined to be 26 and >26 μg a.i/L, respectively. This study 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)

EC50

(μg a.i/L)1,2,3

(95% CL; slope)

Toxicity 

Classification 

(MRID)

Sheepshead minnow 

(Cyprinodon 

variegatus)

96-hour, 

flowthroughTGAI (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 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 3.13. Summary of Chronic Toxicity Data for Estuarine/Marine Fish Exposed to 

Fluazinam.

Species Study Type Test Substance (Purity)

NOAEC; 

LOAEC

(μg 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 EC50 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 and 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 loss of 

equilibrium, erratic swimming, and darkened pigmentation that occurred in the three highest 

treatment concentrations. The LC50 was determined to be 39 μg a.i/L and this study is classified 

as acceptable. These studies classify fluazinam as very highly 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 

measured 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 the 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)

EC50

(μg a.i/L)1,2,3

(95% CL; slope)

Toxicity 

Classification 

(MRID)

Eastern oyster

Crassostrea 

virginica

96-hour, 

flowthrough

TGAI (96.8%) 4.7

(3.6 – 6.0; N/A)

Very highly toxic 

(44807324)

Saltwater mysid

Americamysis bahia

96-hour, 

flowthrough

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/Marine Invertebrates

Exposed to Fluazinam.

Species Study Type Test Substance (Purity)

NOAEC; 

LOAEC

(μg 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 control, 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 

determined 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 LC50 and NOAEC for survival to be >12 

and 12 mg a.i./kg sediment, respectively based on mean measured sediment concentrations and 

>343 and 343 mg a.i/kg sediment based on organic carbon (OC)-normalized sediment 

concentrations. The EC50 and NOAEC for weight were the same values as those determined to 

survival. This study is 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 definitive 

LC50 was not achieved 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/marine sediment studies available for fluazinam. 

Table 3.163. Summary of Sub-chronic Toxicity Data for Freshwater Sediment-Dwelling 

Invertebrates Exposed to Fluazinam.

Species Study 

Type

Test 

Substance 

(Purity)

Sediment LC50

(mg a.i/kg 

sediment)

1

(95% CL; slope)

Pore 

water 

LC50 

(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 

OCnormalized =

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

OCnormalized =

4.0

24 48571414

1

Bolded values represent the most sensitive toxicity endpoints for freshwater 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, Selenastrum capricornutum (MRID 44807334). This 

study determined a 96 hour EC50 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 deviation 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 EC50 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 diatom 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 concentrations were observed to have thin cell walls. The NOAEC and EC50 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.

Table 3.24 Summary of Toxicity Data for Nonvascular Aquatic Plants Exposed to 

Fluazinam.

Species Study Type Test Substance (Purity)

NOAEL; EC50

(ug 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 flosaquae)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; 1.10 (0.49 –

2.40) Cell density (48612301)

N/ANot 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 

Agency 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. Fluazinam is also practically non-toxic to young adult honey 

bees (Apis mellifera) on an acute contact exposure basis. Definitive EC25 and NOAEC values 

were not established in available terrestrial plant studies.

3.3.2.1. Toxicity to Birds

There were three acceptable acute oral studies submitted in support of fluazinam (Table 3.25). 

In one study conducted with the mallard duck (Anas platyrhynchos, MRID 42248622), the LD50

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 weight 

and food consumption. 

In a second study conducted with the northern bobwhite quail (Colinus virginianus, MRID 

42248623), the LD50 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 birds 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 48571409) was 

submitted in support of fluazinam. The study was conducted 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 

approximately. 30 minutes after dosing for four birds in the 2000 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 LD50 was estimated to be >2000 

mg a.i./kg bw. 

Two acceptable avian sub-acute dietary studies were submitted for fluazinam. In studies 

submitted with the bobwhite quail and mallard duck, the LC50 values were determined to be 

>10500 and >10600 ppm, respectively (MRIDs 42248624 and 42248625). In the bobwhite 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 concentration (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 gain 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 treatment 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 therefore 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 fluazinam. 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 on 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 3.175. Summary of Acute and Sub-acute Toxicity Data for Birds Exposed to 

Fluazinam.

Species Study Type Test Substance 

(Purity)

LD50

(mg/kg bw) or

LC50

(mg/kg diet); (95% 

CI; slope)1,2

Toxicity 

Classification (MRID)

Bobwhite quail 

(Colinus virginianus)

Acute oral 

toxicity TGAI (95.3%) 14-d LD50 : 1782 

(1321 – 3595; 5.25)

Slightly toxic

(42248623)

Mallard duck 

(Anas platyrhynchos)

Acute oral 

toxicity TGAI (95.3%) 14-d LD50: > 4190 (N/A; N/A)

Practically nontoxic

(42248622)

Zebra Finch 

(Taeniopygia guttata

Acute oral 

toxicity TGAI (99.3%) 14-d LD50: > 2000 (N/A; N/A)

Practically nontoxic

(48571409)

Bobwhite quail 

(Colinus virginianus)

Subacute dietary 

toxicity TGAI (95.3%) 8-d LC50 : > 10,500 (N/A; N/A)

Practically nontoxic

(42248624)
-Page 56 of 137-

Species Study Type Test Substance 

(Purity)

LD50

(mg/kg bw) or

LC50

(mg/kg diet); (95% 

CI; slope)1,2

Toxicity 

Classification (MRID)

Mallard duck 

(Anas platyrhynchos)

Subacute dietary 

toxicity TGAI (95.3%) 8-dLC50 > 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 LD50 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, 42208406, 

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 among all groups of F0 males and F0 

females treated with 20 or 100 ppm and F0 males treated with 500 ppm were similar to the 

control group means. The F0 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 F1 animals treated with 500 ppm 

had significantly decreased mean body weight gain and food consumption values that were 88% 

and 92% (p< 0.001 and 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 F0

and F1 males and F0 females treated with 500 ppm were significantly increased compared to the 

control group. 

The number of implantation sites observed in F1 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 decreased in the 500 ppm group for F1 litters, but was 

significantly decreased (p<0.05) in the 500 ppm group for F2 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 F1 females (F2 litters). 

Table 3.187. Summary of Acute and Chronic Mammalian Toxicity Data for Rats Exposed 

to Fluazinam.

1,2

Species Study Type

Acute Chronic

LD50

(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 LD50 = 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 of 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 LD50 with technical fluazinam was >200 μg a.i/bee while the formulated 

product LD50 was determined to be >4 μg a.i/bee. The acute oral LD50 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 supplemental 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), formulated fluazinam (38.4%) was 

exposed to earthworms at control, 138, and 1376 mg a.i/kg soil. The 14-day LC50 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 were 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. The 28-day LC50 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 3.198. Summary of Acute Toxicity Data for Beneficial Insects Exposed to Fluazinam.

Species

Study Type 

(TGAI or EP) LD50 (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 NOAEC or an EC05 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 acceptable. 

Table 3.209. Summary of Tier I Toxicity of Fluazinam to Non-target Terrestrial Plants.

Crop Type of Study 

Species

EC25

(lbs a.i./A)

NOAEL

or EC05

(lbs 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

EC25

(lbs a.i./A)

NOAEL

or EC05

(lbs 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 EPISUITE (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 relationships to predict the toxicity of compounds that share similar structural 

moieties. For each degradate of fluazinam, ECOSAR 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 toxicity for a particular taxa are predicted for a degradate, the most 

sensitive estimate was tabulated below in Table 3.31. Table 3.30 shows the ECOSAR classes 

for each degradate for which toxicity estimates were predicted.

Table 3.30. ECOSAR classes with toxicity estimates available for each degradate of 

fluazinam.

Fluazinam Degradate ECOSAR Classes with Toxicity Estimates

CAPA Dinitrobenzenes-acid, Halopyridines-acid

DAPA Anilines (amino-meta), Halopyridines

AMPA Anilines (aromatic amines), Halopyridines

DCPA Dinitrobenzenes-acid, Halopyridines-acid

MAPA Anilines (aromatic amines), Halopyridines

HYPA Phenols, Dinitrophenols, Halopyridines

G-504 Imidazoles-acid, Halopyridines-acid

SDS-67200 Anilines (amino-meta), Halopyridines

Table 3.31. ECOSAR predicted toxicity (μg a.i./L) of the degradates of fluazinam3

Stressor→

Taxa

(Exposure 

type) ↓

Fluazinam4 Fluazinam5 CAPA DAPA AMPA DCPA MAPA HYPA G504

SDS67200

FW Fish

(acute) 36 434 4117 378 406 3893 406 417 36781 346

FW Inverts 

(acute) 180 1086 132291 612 10241 17393 10241 1467 75331 1035

FW Algae

(acute) 180 537 9,2401 931 132651 19137 132651 498791 N/A 1256

SW Fish 

(acute) 120 1739 339081 N/A N/A 82824 N/A 139541 N/A N/A

FW Fish

(chronic) 0.69 14 411 166 7 1657 7 13 1841 382

FW Inverts 

(chronic) 68 302 2,902 182 14 23652 14 1042 891,2 25

SW Fish >26 1562 32422 N/A N/A 86301 N/A 64992 N/A N/A
-Page 60 of 137-

Stressor→

Taxa

(Exposure 

type) ↓

Fluazinam4 Fluazinam5 CAPA DAPA AMPA DCPA MAPA HYPA G504

SDS67200

(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 deemed 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 Information 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 Incident Database System (IDS) maintained by OPP’s Information Technology 

and Resource Management Division (ITRMD) conducted in March 2013 yielded no incidents for 

fluazinam in the main database nor in the aggregate incident module. Because of limitations in 

the 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 assessment of the labeled uses 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 Tables 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, RQs that exceed the non-listed species LOC 

also exceed the listed species LOC.

Tables 4.1 – 4.17 provide the resulting, screening-level RQ values, for taxa with sufficient 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 EC25/EC50 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 Organisms

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 chronic 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). Acute and chronic risk 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 acute 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

EC50 = 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 

Effect3

(1 in ...)

Chronic 

RQ

Apples

NC apple Airblast 38.0 1.06 4.18 X 108 9.31 13.49

OR apple Airblast 12.8 0.36 4.18 X 108 4.04 5.86

PA apple Airblast 32.8 0.91 4.18 X 108 6.43 9.32

Brassica (Cole) Leafy 

Vegetables, plus Turnip 

Greens

CA cole 

crops

Soil drench 

after 

transplant

11.6 0.32 4.18 X 108 3.96 5.74

FL 

cabbage

Soil drench 

after 

transplant

4.44 0.12 4.18 X 108 0.76 1.10

FL 

cabbage

Soil 

incorporp. 

(15 cm)

1.54 0.04 4.18 X 108 0.33 0.47

Bushberry OR 

berries Ground 5.73 0.16 4.18 X 108 1.74 2.52

Carrots

CA row 

crops

Ground 4.14 0.12 4.18 X 108 1.30 1.88

FL 

carrots Ground 15.4 0.43 4.18 X 108 3.36 4.87

Ginseng MN sugar 

beet Ground 5.04 0.14 4.18 X 108 1.27 1.84
-Page 62 of 137-

Use(s) Scenario App. 

Method

Peak 

EECs

(μg 

a.i./L)

Freshwater Fish

EC50 = 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 

Effect3

(1 in ...)

Chronic 

RQ

Lettuce CA 

lettuce Ground 1.65 0.05 4.18 X 108 0.31 0.46

*Edible-Podded Legume 

Vegetables, except peas; 

*Succulent Bean Crop; 

*Dry Bean, except Peas 

and Soybeans

MI beans Ground 3.60 0.10 4.18 X 108 1.05 1.52

OR snap 

beans Ground 1.49 0.04 4.18 X 108 0.56 0.82

Bulb Vegetables 

CA onion Ground 1.16 0.03 4.18 X 108 0.65 0.94

GA onion Ground 14.7 0.41 4.18 X 108 4.69 6.80

Cucurbit Vegetables, 

Melon 

MI 

melons Foliar 19.1 0.53 4.18 X 108 4.45 6.45

MO 

melons Foliar 40.2 1.12 4.18 X 108 8.79 12.74

NJ 

melons Foliar 41.4 1.15 4.18 X 108 7.89 11.43

Fruiting Vegetable, 

Pepper/ Eggplant 

CA 

tomato Foliar 3.73 0.10 4.18 X 108 1.30 1.88

FL 

peppers

Foliar 31.0 0.86 4.18 X 108 7.11 10.30

PA 

tomato Foliar 33.4 0.93 4.18 X 108 8.85 12.83

Peanut NC 

peanut Ground 9.70 0.27 4.18 X 108 2.57 3.72

Potato

ID potato Aerial 1.64 0.05 4.18 X 108 0.91 1.32

ME 

potato Aerial 3.01 0.08 4.18 X 108 1.15 1.67

Soybeans MS 

soybeans Aerial 6.88 0.19 4.18 X 108 2.10 3.04

Turf grasses on golf 

courses

FL turf Ground 5.98 0.17 4.18 X 108 1.16 1.68

PA turf Ground 7.73 0.21 4.18 X 108 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 0.05 – 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 chance of effect was estimated using the study derived 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

EC50 = 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 

Effect1

(1 in ...)

Chronic RQ

Apples

NC apple Airblast 38.0 0.21 7.10 X 105 17.3 0.25

OR apple Airblast 12.8 0.07 7.10 X 105 6.03 0.09

PA apple Airblast 32.8 0.18 7.10 X 105 13.2 0.19

Brassica (Cole) Leafy 

Vegetables, plus 

Turnip Greens

CA cole 

crops

Soil drench 

after 

transplant

11.6 0.06 7.10 X 105 6.20 0.09

FL 

cabbage

Soil drench 

after 

transplant

4.44 0.02 7.10 X 105 1.69 0.02

FL 

cabbage

Soil 

incorporp. 

(15 cm)

1.54 0.01 7.10 X 105 0.610 0.01

Bushberry OR 

berries Ground 5.73 0.03 7.10 X 105 2.92 0.04

Carrots

CA row 

crops

Ground 4.14 0.02 7.10 X 105 1.73 0.03

FL 

carrots Ground 15.4 0.09 7.10 X 105 5.75 0.08

Ginseng

MN 

sugar 

beet

Ground 5.04 0.03 7.10 X 105 2.28 0.03

Lettuce CA 

lettuce Ground 1.65 0.01 7.10 X 105 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 105 1.77 0.03

OR snap 

beans Ground 1.49 0.01 7.10 X 105 0.827 0.01

Bulb Vegetables 

CA onion Ground 1.16 0.01 7.10 X 105 0.886 0.01

GA onion Ground 14.7 0.08 7.10 X 105 6.11 0.09

Cucurbit Vegetables, 

Melon 

MI 

melons Foliar 19.1 0.11 7.10 X 105 8.22 0.12

MO 

melons Foliar 40.2 0.22 7.10 X 105 16.7 0.25

NJ Foliar 41.4 0.23 7.10 X 105 17.7 0.26
-Page 64 of 137-

Use(s) Scenario App. 

Method

Peak 

EECs

(μg 

a.i./L)

Freshwater 

Invertebrates

EC50 = 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 

Effect1

(1 in ...)

Chronic RQ

melons

Fruiting Vegetable, 

Pepper/ Eggplant 

CA 

tomato Foliar 3.73 0.02 7.10 X 105 2.20 0.03

FL 

peppers

Foliar 31.0 0.17 7.10 X 105 14.6 0.21

PA 

tomato Foliar 33.4 0.19 7.10 X 105 15.0 0.22

Peanut NC 

peanut Ground 9.70 0.05 7.10 X 105 4.75 0.07

Potato

ID potato Aerial 1.64 0.01 7.10 X 105 1.13 0.02

ME 

potato Aerial 3.01 0.02 7.10 X 105 1.66 0.02

Soybeans MS 

soybeans Aerial 6.88 0.04 7.10 X 105 3.02 0.04

Turf grasses on golf 

courses

FL turf Ground 5.98 0.03 7.10 X 105 2.18 0.03

PA turf Ground 7.73 0.04 7.10 X 105 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 refer to total toxic residues of fluazinam and 5 degradates of concern 

based on their estimated toxicity through ECOSAR (DAPA, AMPA, MAPA, G-504, SDS67200) Acute and chronic risk quotients for estuarine/marine fish are shown in Table 4.3. 

Acute RQs ranged from 0.01 – 0.35 and chronic RQs ranged from 0.1 – 0.36. 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

EC50 = 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 

Effect1

(1 in ...)

Chronic RQ

Apples

NC apple Airblast 38.0 0.32 4.18 X 108 9.31 0.36

OR apple Airblast 12.8 0.11 4.18 X 108 4.04 0.16

PA apple Airblast 32.8 0.27 4.18 X 108 6.43 0.25

Brassica (Cole) Leafy 

Vegetables, plus 

Turnip Greens

CA cole 

crops

Soil drench 

after 

transplant

11.6 0.10 4.18 X 108 3.96 0.15

FL 

cabbage

Soil drench 

after 

transplant

4.44 0.04 4.18 X 108 0.759 0.03

FL 

cabbage

Soil 

incorporp. 

(15 cm)

1.54 0.01 4.18 X 108 0.327 0.01

Bushberry OR 

berries Ground 5.73 0.05 4.18 X 108 1.74 0.07

Carrots

CA row 

crops

Ground 4.14 0.03 4.18 X 108 1.30 0.05

FL 

carrots Ground 15.4 0.13 4.18 X 108 3.36 0.13

Ginseng

MN 

sugar 

beet

Ground 5.04 0.04 4.18 X 108 1.27 0.05

Lettuce CA 

lettuce Ground 1.65 0.01 4.18 X 108 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 108 1.05 0.04

OR snap 

beans Ground 1.49 0.01 4.18 X 108 0.567 0.02

Bulb Vegetables 

CA onion Ground 1.16 0.01 4.18 X 108 0.652 0.03

GA 

onion Ground 14.7 0.12 4.18 X 108 4.69 0.18

Cucurbit Vegetables, 

Melon 

MI 

melons Foliar 19.1 0.16 4.18 X 108 4.45 0.17

MO 

melons Foliar 40.2 0.34 4.18 X 108 8.79 0.34

NJ 

melons Foliar 41.4 0.35 4.18 X 108 7.89 0.30

Fruiting Vegetable, 

Pepper/ Eggplant 

CA

tomato Foliar 3.73 0.03 4.18 X 108 1.30 0.05

FL 

peppers

Foliar 31.0 0.26 4.18 X 108 7.11 0.27
-Page 66 of 137-

Use(s) Scenario App. 

Method

Peak 

EECs

(μg 

a.i./L)

Estuarine/marine 

Fish

EC50 = 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 

Effect1

(1 in ...)

Chronic RQ

PA 

tomato Foliar 33.4 0.28 4.18 X 108 8.85 0.34

Peanut NC 

peanut Ground 9.70 0.08 4.18 X 108 2.57 0.10

Potato

ID potato Aerial 1.64 0.01 4.18 X 108 0.910 0.04

ME 

potato Aerial 3.01 0.03 4.18 X 108 1.15 0.04

Soybeans MS 

soybeans Aerial 6.88 0.06 4.18 X 108 2.10 0.08

Turf grasses on golf 

courses

FL turf Ground 5.98 0.05 4.18 X 108 1.16 0.04

PA turf Ground 7.73 0.06 4.18 X 108 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/marine 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 0.31 

– 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 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 invertebrate 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

EC50 = 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 108 17.3 8.65
-Page 67 of 137-

Use(s) Scenario App. 

Method

Peak 

EECs

(μg 

ai/L)

Estuarine/marine 

Invertebrates

EC50 = 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 108 6.03 3.02

PA apple Airblast 32.8 6.98 4.18 X 108 13.2 6.60

Brassica (Cole) 

Leafy Vegetables, 

plus Turnip Greens

CA cole 

crops

Soil drench 

after 

transplant

11.6 2.47 4.18 X 108 6.20 3.10

FL 

cabbage

Soil drench 

after 

transplant

4.44 0.94 4.18 X 108 1.69 0.85

FL 

cabbage

Soil 

incorporp. 

(15 cm)

1.54 0.33 4.18 X 108 0.610 0.31

Bushberry

OR 

berries Ground 5.73 1.22 4.18 X 108 2.92 1.46

Carrots

CA row 

crops

Ground 4.14 0.88 4.18 X 108 1.73 0.87

FL 

carrots Ground 15.4 3.28 4.18 X 108 5.75 2.88

Ginseng

MN 

sugar 

beet

Ground 5.04 1.07 4.18 X 108 2.28 1.14

Lettuce CA 

lettuce Ground 1.65 0.35 4.18 X 108 0.667 0.33

*Edible-Podded 

Legume Vegetables, 

except peas; 

*Succulent Bean; 

*Dry Bean, except 

Peas and Soybeans

MI beans Ground 3.60 0.77 4.18 X 108 1.77 0.89

OR snap 

beans Ground 1.49 0.32 4.18 X 108 0.827 0.41

Bulb Vegetables 

CA onion Ground 1.16 0.25 4.18 X 108 0.886 0.44

GA 

onion Ground 14.7 3.13 4.18 X 108 6.11 3.06

Cucurbit Vegetables, 

Melon 

MI 

melons Foliar 19.1 4.06 4.18 X 108 8.22 4.11

MO 

melons Foliar 40.2 8.55 4.18 X 108 16.7 8.35

NJ 

melons Foliar 41.4 8.81 4.18 X 108 17.7 8.85

Fruiting Vegetable, 

Pepper/ Eggplant 

CA 

tomato Foliar 3.73 0.79 4.18 X 108 2.20 1.10

FL 

peppers

Foliar 31.0 6.60 4.18 X 108 14.6 7.30

PA 

tomato Foliar 33.4 7.11 4.18 X 108 15.0 7.50

Peanut NC 

peanut Ground 9.70 2.06 4.18 X 108 4.75 2.38
-Page 68 of 137-

Use(s) Scenario App. 

Method

Peak 

EECs

(μg 

ai/L)

Estuarine/marine 

Invertebrates

EC50 = 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 108 1.13 0.57

ME 

potato Aerial 3.01 0.64 4.18 X 108 1.66 0.83

Soybeans MS 

soybeans Aerial 6.88 1.46 4.18 X 108 3.02 1.51

Turf grasses on golf 

courses

FL turf Ground 5.98 1.27 4.18 X 108 2.18 1.09

PA turf Ground 7.73 1.64 4.18 X 108 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 EC50 value and NOAEC value. Listed species RQs are derived from a comparison of 

the peak EEC to the most sensitive NOAEC and nonlisted RQs are derived from a comparison of 

the peak EEC to the most sensitive EC50 value available. There were no data available for 

aquatic vascular plants 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 

species 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

EC50 = 1.1 μg ai/L

NOAEL = 0.49 μg ai/L

Listed RQs3 Nonlisted RQs4

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 (Cole) 

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

EC50 = 1.1 μg ai/L

NOAEL = 0.49 μg ai/L

Listed RQs3 Nonlisted RQs4

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

*Edible-Podded 

Legume Vegetables, 

except 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 EC50

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 of 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 (Table 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 invertebrates based off of toxicity values expressed in terms of 

sediment concentration ranged from 0.1 – 4.09 and chronic RQs for benthic invertebrates based 

of toxicity values expressed 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

Use(s) Scenario App. 

Method

Acute Chronic

Peak 

Pore 

Water 

EECs

(μg 

ai/L)

Acute 

RQ2

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

Brassica (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 

Legume 

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-

Use(s) Scenario App. 

Method

Acute Chronic

Peak 

Pore 

Water 

EECs

(μg 

ai/L)

Acute 

RQ2

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 (EC50 value of most sensitive freshwater 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) RQs for estuarine/marine 

sediment-dwelling 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 peak 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. 

Table 4.7. Acute RQ and Chronic RQs for Direct Effects to Estuarine/Marine SedimentDwelling Invertebrates from Fluazinam TGAI.4

Use(s) Scenario App. Method

Acute Chronic

Peak Pore 

Water 

EECs

(μg ai/L)

Acute 

RQ2

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 

RQ2

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 (EC50 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 were 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-

LC50 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 4.11. 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 TREX are shown in Table 4.12. 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 4.12. 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 Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 LD50 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 toxicity data for 

laboratory rats, and the most sensitive dietary item and size class for that species. For mammals

the most sensitive RQ in T-REX is for the small 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 mammals. 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 4.14. All uses of fluazinam resulted 

in the exceedance of the chronic LOC for all size classes consuming at least one fluazinamcontaminated food item. Chronic dietary-based RQs are presented in Table 4.15. All uses of 

fluazinam resulted in the exceedance of the chronic LOC for mammals consuming at least one 

fluazinam-contaminated food item n a dietary-basis.
-Page 78 of 137-

Table 4.13. Acute 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 Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items 

Short Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 LD50 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 4.14. 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 Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items 

Short Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 4.15. 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

Broadleaf 

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 using the TerrPlant (v.1.2.2) model. The TerrPlant derived EECs are 

compared to the most sensitive monocot and dicot EC25 to generate a non-listed species RQ and 

compared to the most sensitive NOAEC or EC05 to generate a listed species RQ. The listed and 

non-listed terrestrial plant LOC is 1. The available seedling emergence study did not definitively 

achieve a NOAEC or EC05 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 were 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 Values2

Spray Drift Only

Runoff and 

Spray Drift 

(Dry Areas)

Runoff and 

Spray Drift

(Semi-Aquatic Areas)

Nonlisted 

Species

Listed 

Species

Nonlisted 

Species

Listed 

Species1

Nonlisted 

Species

Listed 

Species1

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

LOCfor listed and non-listed species = 1

Table 4.17. RQs for Nontarget Dicot Adjacent to Fluazinam Use Areas.

Crop

Single Max. 

Application 

Rate

(lbs ai/A)

Dicot RQ Values2

Spray Drift Only

Runoff and 

Spray Drift 

(Dry Areas)

Runoff and 

Spray Drift

(Semi-Aquatic Areas)

Nonlisted 

Species

Listed 

Species

Nonlisted 

Species

Listed 

Species1

Nonlisted 

Species

Listed 

Species1

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 Values2

Spray Drift Only

Runoff and 

Spray Drift 

(Dry Areas)

Runoff and 

Spray Drift

(Semi-Aquatic Areas)

Nonlisted 

Species

Listed 

Species

Nonlisted 

Species

Listed 

Species1

Nonlisted 

Species

Listed 

Species1

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 4.18). 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 4.18. Summary of RQ Values for Mammals and Birds Consuming Fish 

Contaminated by Fluazinam1

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 

fluazinam 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 108. Additionally, there were no ecological incidents reported for freshwater fish 

resulting from the use of fluazinam. For risk assessment purposes, freshwater fish serve as 

surrogates for aquatic-phase amphibians.

There is some conservatism in the fact that chronic freshwater fish RQs were derived using the 

60-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 

exceeded 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 fluazinam 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 less 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 stressor 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 freshwater invertebrates was derived 

using a study-calculated slope of 3.6 which yielded a probability of 1 in 7.10 X 105

. 

Additionally, there were no ecological incidents reported to freshwater invertebrates resulting 

from the use of fluazinam.

Refer to the 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 associated residues of 5 degradates of concern) have the potential for direct 

adverse effects to listed freshwater invertebrates on an acute basis (acute RQs: 0.01 – 0.35). 

There were no exceedances of the acute high risk (non-listed) species LOC of 0.5 for 

estuarine/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 absence of one in the 
-Page 85 of 137-

available data and yielded a probability of 1 in 4.18 X 108. 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 acute 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 108

. Additionally, 

there were 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 does 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 wereequally 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 mentioned 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 

gallons/acre). 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 drift 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 applying a spray volume of 5 gallons/acre (which is specified in the label for 

Omega 500F), the spray drift is 4.1%. This 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 is 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 coarser 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

(ddmm)

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 0.57

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 decreases in the peak EECs for the ground 

applications, relative to the aerial applications, are substantial.

When compared to the available acute and chronic 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 exceeded 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 RQs for Estuarine/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

EC50 = 120 μg ai/L 60-day 

EECs

(μg ai/L)

Estuarine/marine 

Fish

NOAEC =

26 μg ai/L

Acute 

RQ

Probability of 

Acute Effect1

(1 in ...)2

Chronic RQ

Potato ID potato Aerial 1.64 0.01 4.18 X 108 0.910 0.04

Ground 0.694 0.01 4.18 X 108 0.465 0.02

ME potato Aerial 3.01 0.03 4.18 X 108 1.15 0.04

Ground 2.65 0.02 4.18 X 108 0.794 0.03

Soybeans MS 

soybeans

Aerial 6.88 0.06 4.18 X 108 2.10 0.08

Ground 7.09 0.06 4.18 X 108 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 of a buffer zone (Table 4.21). Acute RQs for the ground and 

aerial potato 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 

aerial scenarios exceeded the chronic LOC of 1 for the soybean use. T

Table 4.21. Acute and Chronic RQs for Estuarine/marine Invertebrates Resulting from

Aerial and Ground Applications of Fluazinam on Potatoes and Soybeans with Buffer 

Zone1,2

Use(s) Scenario App. 

Method

Peak 

EECs

(μg 

ai/L)

Estuarine/marine 

Invertebrates

EC50 = 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 108 1.13 0.57

Ground 0.694 0.15 4.18 X 108 0.534 0.27

ME potato Aerial 3.01 0.64 4.18 X 108 1.66 0.83

Ground 2.65 0.56 4.18 X 108 1.19 0.60

Soybeans MS 

soybeans

Aerial 6.88 1.46 4.18 X 108 3.02 1.51

Ground 7.09 1.51 4.18 X 108 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 estuarine/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 estuarine/marine invertebrates in the absence of estuarine/marine benthic 

invertebrate data.

Table 4.22. Acute and Chronic (pore water) RQs for Estuarine/marine Sediment-Dwelling 

Invertebrates Resulting from Aerial and Ground Applications of Fluazinam on Potatoes 

and Soybeans with Buffer Zone1,4

Use(s) Scenario App. 

Method

Peak Pore 

water 

EECs

(μg ai/L)

Estuarine/marine 

Invertebrates

EC50 = 4.7 μg ai/L

21-day 

pore water 

EECs

(μg ai/L)

Estuarine/marine 

Invertebrates

NOAEC =

2 μg ai/L

Acute RQ2 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 (EC50 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 KOW = 

3.56) and a tendency to partition with soils with moderately high KOCs. 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 (KOC = 1958 mL/gOC). Acute 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 EC50. 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 EC50 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 estimate a sediment-based 

chronic RQ.
-Page 89 of 137-

Freshwater benthic invertebrate acute RQs (peak pore water EECs/lowest water column 

invertebrate EC50) did not exceed any acute risk LOC and met the acute endangered species LOC

(RQs ranged from <0.01 – 0.05) for one use only (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 and 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 fluazinam. 

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 plants in that there is no suitable data available for estimating risk to vascular aquatic 

plants. Risk can be presumed however as data would need to show an EC50 that is 36 times less 

toxic than the most sensitive non-vascular aquatic plant study to not exceed the non-listed 

species LOC and the NOAEC would have to be 82 times less toxic than the most sensitive nonvascular 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 are 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 TREX 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-day 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 half 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 for 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 endangered 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,” LC50 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 exceeded 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 with northern 

bobwhite quail) during the time of application and for several weeks after the last application (TREX 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, 

pods, 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 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 
-Page 91 of 137-

does not have a soil drench method nor does it allow for a soil incorporation depth as 

PRZM/EXAMS does with 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 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 brassica 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 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 higher 

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 107 chance 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 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 for mammals do not exceed any acute LOC for registered uses of fluazinam 

(RQs 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 for 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 greater chronic risk than a mammal that feeds on fruits, pods, 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 RQs 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 conservatism 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 probability of an individual chance of effect. The model yielded a 

probability of 2.94 X 105 chance of effect. Additionally, there are no reported incidents 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 young adult 

(foraging) bees at any treatment level, with corresponding LD50 values of >100 μg ai/bee for oral 

exposure and >200 μg a.i/bee for contact 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 EC05 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-aquatic 

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 non-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 dietarybased risk for birds as a result 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. 

According 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 (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. This suggests (and is supported by 

KABAM derived RQs) that while fluazinam has the potential to bioaccumulate in fish, that the 

rate 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 reviews 

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 general 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, reproductive 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 Formulation 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 

subject 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 screening 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 substance, 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 ingredients. 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 callins, requiring the submission of EDSP screening 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, freshwater and estuarine/marine fish, 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-dwelling 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 associated 

with modification of primary constituent elements of designated critical habitats, where such 

designations have been made. However, at this current stage of the Registration Review process, 

it is premature to make effects determinations for listed 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 information 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 developing 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 Registration 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, including 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 more 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 announced 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 for 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:

• identifying 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; 

• incorporating 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 risk 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 individual 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 quizalofopp-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 species 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 subcounty level 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 species, and/or the United States Fish and Wildlife Service (USFWS) 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 the 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 existence 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 registration 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 distribution of any listed species (USEPA 2004). After the Agency’s screening 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 action 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 comprehensive 

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 considers 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 and 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 screening-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 listed 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 depend 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 regarding 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 models 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 growth 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 not 

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 broad 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-level 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, the 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 calculated by multiplying the non definitive honey bee acute contact 

LD50 (>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 invertebrates (>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 137-

is some certainty in the fact that the RQs listed represent a “worst case,” scenario. All registered 

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 higher 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 

at Max 

Rate

Min. 

Interval 

Between 

Apps (days)

Arthropod 

Dietary-based 

EEC (ppm)

Terrestrial 

Invertebrate 

RQ1

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 1st 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 plants –

monocots and dicots Uncertain4 Birds, Mammals

Aquatic nonvascular plants Yes1 Fish1

Aquatic vascular plants Uncertain5 Aquatic nonvascular plants, 

Fish1
-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 

Acute Chronic Effects on ...

Terrestrial invertebrates Yes6 ND Plants

Mammals No Yes3 Plants, Fish1,2

Birds Yes Yes3 Plants, Fish1,2

Reptiles Yes Yes3 Plants

Amphibians Yes1 Yes3

Plants, Aquatic nonvascular 

plants, Fish1, Freshwater 

invertebrates1, Mammals

Freshwater fish Yes1 Yes3 Aquatic nonvascular plants, 

Freshwater invertebrates1

Freshwater invertebrates (crustaceans) Yes1 No Aquatic nonvascular plants, 

Fish1

Molluscs Yes1 ND Aquatic nonvascular plants, 

Fish1

Estuarine/marine fish Yes1 No

Aquatic nonvascular plants, 

Estuarine/marine 

invertebrates1

Estuarine/marine invertebrates 

(crustaceans) Yes1 Yes3 Aquatic nonvascular plants, 

Fish1

Freshwater benthic organisms Yes1 Yes3 Aquatic nonvascular plants, 

Fish1

Estuarine/marine benthic organisms Yes1 Yes3 Aquatic nonvascular plants, 

Fish1

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 EC05 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, “Given the uses of fluazinam

and its environmental fate properties, there is a likelihood of acute and chronic exposure to nontarget aquatic and terrestrial organisms. Therefore, when 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 both 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 similar backbone structure in high pH 

solutions (t1/2 = 5.6 days at pH 9) or in anaerobic 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 

products, 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. Fluazinam does not alter substantially 

its backbone structure in the environment; instead, it undergoes slight transformations of 

functional groups, EFED has considered parent and certain transformation products in this 

assessment. EFED calculated the decay half-lives 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 via 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 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 
-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 granivores 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 or 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 KOW and KOCs) 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. Additionally, 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 fish 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 aerobic 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 characterizing 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 uses 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 ranging 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 since 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 days 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 

application 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 fluazinam 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 m3

) pond with no outlet. Exposure 

estimates 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 and 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 higher 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 has 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 concentrations 

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 well 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. The 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. 

Additionally, 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 effectiveness 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 vegetative 

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, the buffer zone from the treated field was 10 ft wide (while the label 

requires 25 ft). Fluazinam runoff reductions 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, there is 

potential for important chemical transformations to occur. Many chemical compounds can 

undergo changes in mobility, toxicity, or persistence when changes in pH, Eh (redox potential), 

salinity, dissolved oxygen (DO) content, or temperature are encountered. 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), Eh 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 

contributions 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 concentrations 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 within 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 effects 

(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 acknowledges 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

There 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 frequency 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 estimates 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 assessment. 

8.2.1.1. Uncertainties Associated with T-REX

There 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 studies demonstrating that the foliar 

dissipation half life is less than 35 days. For fluazinam, there are two foliar dissipation studies 

available (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-based 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 the 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 exceedances using the default half life and so these RQs 

would be further reduced. For chronic risk, every registered 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 day half life, 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 overestimate 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 screening 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 toxicant. 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 juveniles, 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 the 

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 surrogates 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 information 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 represented 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 environment. 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 sensitive 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 most 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 applied 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/EXAMS 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 brassica 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 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 higher 

EEC and therefore RQs, that is, this use did not represent the highest risk 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 amphibians 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 RQs for the Specified Dietary Items and 

Size Class as compared to the EEC or RQ for Small Birds1 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/small

Insects 56% 56% 32% 25% 14% 8%

Fruits/pods/seeds/large

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/small

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 Classes2

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 EECs 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 dietary 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, many 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 consideration 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 species 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 data 

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 listed 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 benthic 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 concentrations.

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 estimating 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 Series 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 April 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 

Information 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 Germany, 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 Resources Conservation 

Service. 25 pp. 

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

and Development, Washington, D.C.

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

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

April, 1998.

USEPA. 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. Office of Prevention, Pesticides and Toxic Substances, Office of 

Pesticide Programs, Washington, D.C. Available online at 

http://www.epa.gov/oppfead1/endanger/consultation/ecorisk-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 2009a. 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 at: 

http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm (accessed 

03/27/2013). 

USEPA 2009c. ECOTOXicology Database, v. 4.0. Accessed March 2013. Available 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) Fluazinam 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: IB2001-MAP-008-01: 5312-94-0119-EF-002. Unpublished study prepared by Ricerca, LLC. 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-EF001. 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 of 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) IKF1216: 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 Columns: 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 ThickLayer Chromatograms: Lab Project Number: RJO421B. Unpublished 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 Ag. 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) Stability 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 of 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) Terrestrial 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 Dissipation 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, Inc. 271 p. 

MRID 44807321. Robinson, R.; Hoffman, S. (1995) Confined Rotational Crop Study on Fluazinam (IKF1216): 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 prepared 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;sponsored 

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 Identification

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.; Anderson, 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 Technical (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 Fluazinam (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. 

MRID 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 study 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 prepared 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 Conditions 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 Number: 

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 Technical Fluazinam (IKF-1216): Lab Project Number: 5109-91-0419-TX002: 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 Toxicity 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-BE-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 study 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 Services. 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 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 
-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 Duckweed, 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 Green Alga 

(Pseudokirchneriella subcapitata): Lab Project Number: 13562.6115: 022002/OPPTS/SAPSS/ISHIHARA. Unpublished study prepared by Springborn Smithers Laboratories. 55 p. {OPPTS 

850.5400} 

MRID 45822105. Hoberg, J. (2002) IKF-1216 Technical--Acute Toxicity 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/SAANABAENA/ISHIHARA. Unpublished study prepared by Springborn Smithers Laboratories. 54 p. 

{OPPTS 850.5400} 

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 42208411. 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 44807335. 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. Yearsdon, 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 1Appendix 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

0.592592592592593 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

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
-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)

Benthic 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 1.671 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 1.886 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 averages: 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 0.504 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
-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 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

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 2Appendix 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 EECs and RQs 

Based on the Registered Use of Fluazinam on Citrus.
-Page 126 of 137-

Appendix 3Appendix C. Example Terrplant (v. 1.2.2) Input and Output for Fluazinam

Appendix 4Appendix D. STIR Results.
-Page 127 of 137-
-Page 128 of 137-

Appendix 5Appendix E. SIP Results.

Table 1. Inputs

Parameter Value

Chemical name Fluazinam

Solubility (in water at 25oC; mg/L) 0.071

Mammalian LD50 (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 LD50 (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 6Appendix 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.

For 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 

matrix 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 curves 

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 two 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 requirement, a method for the 

analysis of AMPA in water is also needed.

NonguidelineRunoff 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)

Nonguideline 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

Nonguideline 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)

71-1

(850.2100)

Avian Acute Oral 42248622

42248623

48571409

Acceptable

Acceptable

Acceptable

NA

71-2

(850.2200)

Avian Sub-acute 

Dietary

42248624

42248625

Acceptable

Acceptable

NA

71-4

(850.2300)

Avian Reproduction 44807323

44831907

Acceptable

Acceptable

NA

72-1

(850.1075)

Freshwater Fish –

Acute Toxicity

42208409

42974904

42974905

Acceptable

Acceptable

Acceptable

NA

72-2

(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)

72-3

(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

72-4

(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

123-1a

(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 8Appendix H. KABAM Output
-Page 136 of 137-
-Page 137 of 137-