                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460
                                       
                          OFFICE OF CHEMICAL SAFETY 
                           AND POLLUTION PREVENTION

                                       
Environmental Fate and Ecological Risk Assessment for Fenpyrazamine New Chemical Registration for Proposed Uses on Almonds, Pistachios, Lettuce, Strawberries, Bushberries, Caneberries, Ginseng, and Ornamentals
                                       
                                      \s
                        Chemical Formula:  C17H21N3O2S
                               PC Code:  090109
                           CAS Number:  473798-59-3
                                       


Prepared by:
Gabe Rothman, Environmental Scientist
Justin Housenger, Biologist 

Reviewed by:
José Melendez, Chemist
Al Vaughan, Risk Assessment Project Leader, ERB5
Mah Shamim, Ph.D., Branch Chief, ERB5
                                                                               
                                  United States Environmental Protection Agency
                                                   Office of Pesticide Programs
                                        Environmental Fate and Effects Division
                                                    Environmental Risk Branch V
                                                         1200 Pennsylvania Ave.
                                                               Mail Code 7507P 
                                                         Washington, D.C. 20460


                               Table of Contents

1.	Executive Summary	5
1.1	Nature of Chemical Stressor	5
1.2	Potential Risks to Non-target Organisms	6
1.2.1	Aquatic Animals and Plants	6
1.2.2	Terrestrial Animals and Plants	7
1.3	Risk Characterization	8
2.	USE CHARACTERIZATION	8
3.	ENVIRONMENTAL FATE AND TRANSPORT CHARACTERIZATION	9
4.	ECOLOGICAL TOXICITY CHARACTERIZATION	20
4.1	Receptors	20
4.2	Ecosystems at Risk	21
4.3	Assessment Endpoints	22
4.4	Ecological Effects Characterization	22
4.4.1	Aquatic Effects	23
*	Freshwater Fish	31
*	Freshwater Invertebrates	32
*	Estuarine/Marine Fish	33
*	Estuarine/Marine Invertebrates	34
*	Benthic (Sediment Dwelling) Invertebrates	35
*	Vascular and Non-vascular Aquatic Plants	36
4.4.2	Terrestrial Effects	38
*	Birds (Acute Toxicity)	42
*	Birds (Chronic Toxicity)	42
*	Mammals (acute toxicity)	43
*	Mammals (chronic toxicity)	43
*	Non-target Beneficial Insects	44
*	Other Non-target Terrestrial Organisms	44
*	Terrestrial Plants	45
5.	PROBLEM FORMULATION	46
5.1	Risk Hypotheses	46
5.2	Conceptual Model	47
5.3	Analysis Plan	48
5.3.1	Measures of Exposure	48
5.3.2	Measures of Effects	49
5.3.3	Integration of Exposure and Effects	49
6.	EXPOSURE ANALYSIS	50
7.	RISK CHARACTERIZATION	60
7.1	Risk Estimation - Integration of Exposure and Effects Data	60
7.1.1	Non-target Aquatic Animals and Plants	60
a.	Water Column Exposure: Acute and Chronic Risk to Animals	61
b.	Sediment Exposure: Chronic Risk to Benthic Invertebrates	64
c.	Aquatic Plants	67
7.1.2	Non-target Terrestrial Animals	69
a.	Acute and Chronic Risk to Birds	69
b.	Acute and Chronic Risk to Mammals	70
c.	Non-target Beneficial Insects	72
d.	Risks to Terrestrial Plants	73
7.2	Risk Description	74
7.2.1	Risks to Aquatic Animals	74
a.	Potential for Acutely Toxic Exposures	74
b.	Potential for Chronically Toxic Exposures	75
7.2.2	Risks to Terrestrial Animals	79
a.	Potential for Acutely Toxic Exposures	79
b.	Potential for Chronically Toxic Exposures	80
7.2.3	Risks to Terrestrial Plants	81
7.2.4	Review of Incident Data	81
7.2.5	Threatened and Endangered Species Concerns	81
7.2.6	Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps	83
a.	Incidental Pesticide Releases Associated with Use	83
b.	Exposure for Aquatic Species	83
c.	Exposure for Terrestrial Species	86
d.	Effects Assessment	86
*	Age Class and Sensitivity of Effects Thresholds	87
*	Lack of Effects Data for Amphibians and Reptiles	87
*	Use of the Most Sensitive Species Tested	88
8.	IDENTIFICATION OF DATA GAPS	88
9.	REFERENCES	89
*	Environmental Fate Studies	89
*	Ecological Effects Studies	91
Open Literature and Government Reports	96

                                  Appendices

Appendix A.  The Risk Quotient Method and Levels of Concern
Appendix B.  Output of STIR Results
Appendix C.  Output of SIP Results
Appendix D.  Output of TerrPlant Results
Appendix E.  Sample PRZM/EXAMS Input and Output Files
Appendix F.  Formation of Fenpyrazamine Transformation Products in Environmental Fate Studies.
Appendix G.  Toxicity Comparisons of Fenpyrazamine and Transformation Products


                               Table of Figures
                                       
Figure 1.  Proposed degradation and dissipation pathways in soil.	15
Figure 2.  Proposed degradation and dissipation pathways in water.	17
                                       
                                Table of Tables
                                       
Table 1.  Summary use information for fenpyrazamine, based on the proposed V-10135 4 SC Fungicide suspension concentrate label by Valent U.S.A.	9
Table 2.  Physical and chemical properties of fenpyrazamine.	10
Table 3.  Summary of fenpyrazamine environmental fate properties.	10
Table 4.  Comparison of physical chemical properties of fenpyrazamine transformation products to parent fenpyrazamine.	18
Table 5.  Taxonomic groups and test species evaluated for ecological effects in this screening-level risk assessment	20
Table 6.  Toxicity endpoints used in risk quotient calculations.	21
Table 7.  Toxicity reference values for aquatic organisms exposed to fenpyrazamine.	23
Table 8.  Toxicity Reference Values For Aquatic Organisms Exposed to Degradation Products of Fenpyrazamine.	30
Table 9.  Toxicity Reference Values For Terrestrial Organisms Exposed To Fenpyrazamine.	38
Table 10.  Summary of PRZM/EXAMS input parameter values for physical chemical and fate properties used for fenpyrazamine surface water aquatic EECs.	50
Table 11.  Crop management PRZM/EXAMS inputs used in aquatic exposure modeling.	52
Table 12.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in surface water (ppb) for aerial applications of fenpyrazamine.	54
Table 13.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in surface water (ppb) for ground applications of fenpyrazamine.	55
Table 14.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in benthic pore water (ppb) for aerial applications of fenpyrazamine.	55
Table 15.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in benthic pore water (ppb) for ground applications of fenpyrazamine.	56
Table 16. PRZM/EXAMS estimated one-in-ten year upper bound concentrations in sediment (mg fenpyrazamine/kg sediment, dry weight) for aerial applications of fenpyrazamine.	56
Table 17.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in sediment (mg fenpyrazamine/kg sediment, dry weight) for ground applications of fenpyrazamine.	57
Table 18.  Terrestrial food item residue estimates for birds with proposed fenpyrazamine uses on various crops.	58
Table 19.  Terrestrial food item residue estimates for mammals with proposed fenpyrazamine uses on various crops.	58
Table 20.  TerrPlant derived EECs for dry and semi-aquatic areas resulting from proposed fenpyrazamine uses.	59
Table 21.  Acute and chronic RQs for evaluating risk of fenpyrazamine exposure to freshwater and estuarine/marine fish.	62
Table 22.  Acute and chronic RQs for evaluating risk of fenpyrazamine exposure to freshwater and estuarine/marine invertebrates.	63
Table 23.  Chronic RQs for risk of fenpyrazamine exposure to freshwater benthic invertebrates[1,2].	65
Table 24.  Chronic RQs for risk of fenpyrazamine exposure to estuarine/marine benthic invertebrates[1,2,3].	66
Table 25.  RQs for evaluating toxic risk of fenpyrazamine exposure to vascular and non-vascular aquatic plants.	67
Table 26.  Dose-based RQs for birds due to exposure to proposed uses of fenpyrazamine.	69
Table 27.  Dietary-based RQs for birds due to exposure to proposed uses of fenpyrazamine.	70
Table 28.  Acute dose-based RQs for mammals due to exposure to proposed uses of fenpyrazamine.	71
Table 29.  Chronic dose-based RQs for mammals from exposure to proposed uses of fenpyrazamine.	71
Table 30.  Chronic dietary-based RQs for mammals due to exposure to proposed uses of fenpyrazamine.	72
Table 31.  RQs for terrestrial plants resulting from the propose uses of fenpyrazamine.	73


       
   1. Executive Summary
 
This ecological risk assessment addresses the new active ingredient fenpyrazamine which is proposed to be used in conventional ground and aerial foliar applications on almonds, grapes, lettuce, and strawberries as major food uses as well as on ornamentals as the only major non-food use.  Additional IR-4 minor crop uses proposed for fenpyrazamine are conventional ground and aerial foliar applications on pistachio, bushberry, caneberry, and ginseng crops.  Proposed maximum application rates of fenpyrazamine on crops range between 0.375 lbs. a.i./A  -  1.089 lbs. a.i./A with three to four retreatment intervals at a minimum of 7 seven days between applications specified on the draft product label.

         1.1 Nature of Chemical Stressor  
 
The subject chemical addressed in this ecological risk assessment is identified by the chemical fenpyrazamine (PC Code 090109) with the chemical synthesis (IUPAC) name of S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothiaote.  Fenpyrazamine is a pyrazole fungicide intended to control a number of fungal diseases including brown rot, green fruit rot/jacket rot, botrytis bunch rot, lettuce drop, gray mold, and botrytis blight gray mold.   Fenpyrazamine's mode of action has not been fully elucidated, but it is thought to inhibit the generation of reproductive spores via inhibition of the germ tube and mycelium elongation.  In addition, pyrazole fungicides are known to inhibit the succinate-dehydrogenase enzyme which serves a critical mechanism as part of the citric acid cycle and providing a pathway for electronic transfer throughout the organism.  The trade name for this compound is V-10135 4 SC Fungicide (a suspension concentrate).  The labeled formulation contains 43.6 percent of the active ingredient fenpyrazamine and 56.4 percent inert ingredients.   
 
Fenpyrazamine foliar applications using ground and aerial sprays may impact aquatic habitats within water bodies and ground water given that it possesses similar physical chemical properties and persistence as other chemicals which are known to translocate to these media.  In addition, fenpyrazamine applications potentially result in dietary exposure and exposure to plants in the terrestrial environment given its moderate to high persistence in the environment.  Fenpyrazamine is moderately persistent in alkaline aerobic soil with half lives ranging between 38 and 49 days.  However, fenpyrazamine degrades much slower in acidic aerobic soil, with half-lives between 201  -  801 days.  In anaerobic acidic soil environments, half-lives are a little less at 128 days.  Once reaching the water column, fenpyrazamine is moderately persistent to persistent, especially in acidic environments, with half-lives ranging from 12 days  -  280 days under aerobic and anaerobic conditions.  Fenpyrazamine's rapid hydrolysis at pH9 (with a half-life of 12 days) and high stability at pH5 suggests that hydrolysis may mediate fenpyrazamine's degradation in the environment.  Fenpyrazamine (S-2188) degrades mainly to S-2188-OH, S-2188-DC, and MCNI in soil and water.  However, submitted ecotoxicity toxicity data as well as structural activity relationships (ECOSAR v.1.0) indicates that fenpyrazamine is at least an order of magnitude or more toxic than these degradates depending on the taxa.  Therefore, fenpyrazamine is considered the primary stressor in this risk assessment.  Further information related to the justification of fenpyrazamine as the primary stressor is provided in Section 5.2.

         1.2 Potential Risks to Non-target Organisms 

This is the Environmental Fate and Effects Division's (EFED) national screening-level ecological risk assessment for the proposed registration of fenpyrazamine.  A summary of the major conclusions and uncertainties of this assessment for aquatic and terrestrial receptors respectively is included below.  
 
                 1.2.1 Aquatic Animals and Plants
 
 Acute Risk Concerns: The results of this screening-level risk assessment suggest minimal acute risk of acute toxicity to freshwater and estuarine/marine fish and freshwater invertebrates based on runoff and spray drift from foliar applications to adjacent surface waters.  There were no LOC exceedances for these three taxa.  There was acute risk indicated to listed species and risks that could be mitigated by restricted use for estuarine/marine invertebrates from the proposed uses on ginseng and ornamentals.    
 Chronic Risk Concerns: Chronic risks to freshwater fish and aquatic (freshwater and estuarine/marine) invertebrates were below the Agency's chronic LOCs for all proposed uses of fenpyrazamine.  Chronic risks to estuarine/marine fish could not be determined with precision due to a non-definitive NOAEC (< 39 ug a.i/L).  Despite the lack of bonded estimation of chronic risk for estuarine/marine fish, (i.e., RQ values preceded by ">") the LOC of 1 was exceeded for the proposed uses on ornamentals and ginseng.  However there is uncertainty with this and the remaining chronic RQ values for estuarine/marine fish as it is not known how far above the estimated RQ that the actual RQ falls.  A similar case exists with estuarine/marine invertebrates (NOAEC of 98 ug a.i/L).  However in this case, the RQ would be preceded by "<" values to indicate that the estimated RQ is an "at most," scenario.  For both freshwater and estuarine/marine invertebrates, there were no exceedances of the chronic LOC for any of the proposed uses of fenpyrazamine.
 
 Risks to Aquatic Plants: Based on the available data to one vascular and 4 non-vascular aquatic plant species, risks to aquatic plants are indicated for non-vascular plants but not for vascular plants.  Toxicity data indicated that the most sensitive non-vascular aquatic plant was 2 orders of magnitude more sensitive than vascular aquatic plants which led to the listed LOC being exceeded for all uses of fenpyrazamine and to non-listed LOCs being exceeded for all uses except almonds and pistachios for non-vascular plants.  There were no non-listed or listed LOC exceedances for vascular aquatic plants for all proposed uses of fenpyrazamine.  
 
 Risks to Benthic Invertebrates:  Chronic data are available for 3 species of freshwater and estuarine/marine benthic invertebrates.  However, the chronic RQs could not be estimated with precision due to non-definitive endpoints being reached for the most sensitive freshwater and estuarine/marine benthic invertebrate endpoints (NOAECs of <101 and <3000 ug a.i/kg sediment, respectively).  Using the chronic LOC of 1 and the 1-in-10 year 21-day average EECs for risk estimation purposes, sediment RQs exceeded the LOC for freshwater benthic invertebrates for the proposed uses on ornamentals and ginseng.  Corresponding pore water EECs also exceeded the LOC for the ornamental and ginseng uses.  For estuarine/marine benthic invertebrates, there was no sediment or pore water RQs that exceeded the LOC.  As was the case for chronic risk to estuarine/marine fish, there is uncertainty with these chronic RQ values as it is not known how far above the estimated RQ that the actual RQ falls.  
 
                 1.2.1 Terrestrial Animals and Plants
 
 Acute Risks Concerns for Birds and Mammals:  Acute dose-based risks for birds were indicated for small birds eating short grass for all proposed uses of fenpyrazamine.  There were other LOC exceedances for additional food items and size class of organisms depending on the use.  The acute high risk LOC of 0.5 was exceeded only in the case of small birds eating short grass for the ornamental use.  Other LOC exceedances were the acute endangered species LOC (0.1) and the acute restricted use LOC (0.2).  There were no acute dietary based exceedances for birds except a marginal exceedance of the acute endangered species LOC for dietary ingestion of short grass under the ornamental use.  Acute dose-based risks for mammals indicated marginal exceedances of the acute endangered species LOC (0.1) for small and medium sized mammals ingesting short grass under the ornamental use.    
 
 Chronic Risk Concerns for Birds and Mammals:  A potential for chronic risks to birds and mammals was indicated in this assessment via dietary-based exposure.  Exceedances of the chronic LOC of 1 were indicated for all proposed uses of fenpyrazamine except the uses on almonds and pistachios for at least one food item.  Chronic dose-based RQs for mammals indicate exceedances of the LOC for small and medium sized mammals exposed to at least one food item for all proposed uses and exceedances for all three size classes for the ornamental use only.  There were no chronic dietary-based RQ exceedances for any of the proposed uses.   
 
 Risk Concerns for Terrestrial Plants:  For almonds and pistachios, the acute LOC of 1 was exceeded for listed dicot species in semi aquatic areas.  There were no other LOC exceedances for this use.  For lettuce, grapes, bushberries, caneberries, strawberries, and ginseng, the acute LOC of 1 was exceeded for listed dicot species in semi aquatic areas with no other LOC exceedances.  For the use on ornamentals, listed monocot species in semi aquatic areas and listed dicot areas in dry, semi aquatic, and areas resulting from spray drift all exceeded the acute LOC.  Therefore, the potential for risk is indicated to these groups of terrestrial plants from the uses exceeding the LOC of 1. 
 
 It is important to note that the RQs summarized in Table 32 did not have EC25 endpoints input into the TerrPlant model for vegetative vigor on account of a lack of a 25% or greater inhibition for all variables for these studies precluding that endpoint to be estimated.  Furthermore, the NOAEC for seedling emergence for dicot species was a non-definitive endpoint (<0.035 lbs a.i/A).  Additionally, the EC25 values for seedling emergence (monocot and dicot) were non definitive (>1.54 ad >0.53 for monocots and dicots, respectively).  Therefore the RQs are not determined to be precise, and there exists uncertainty with these endpoints that arise from the use of non-definitive RQs.   
 
Risk Concerns for Beneficial Insects: Available toxicity data for fenpyrazamine indicate it is practically non-toxic to honeybee on an acute contact and an acute oral basis.  While exposure potential exists via pathways such as spray drift, limited data available show fenpyrazamine to be of limited toxicity to the honey bee.  	Additionally, an acute toxicity study to the earthworm indicated that survival ranged from 92.5 to 100%, depending on the treatment concentration.  The LC50 was determined to be >800 mg a.i/kg dw soil and therefore the data (while limited) suggest fenpyrazamine to be of low toxicity to the earthworm.
 		
         1.2 Risk Characterization 
 
In characterizing the risk to terrestrial and aquatic organisms exposed to fenpyrazamine, the largest uncertainties in the currently submitted registrant data is the absence of environmentally-relevant hydrolysis data at pH7 and availability of data in only one water-sediment system anaerobic aquatic metabolism study.  .  Therefore, to address these deficiencies, conservative assumptions are made within the PRZM/EXAMS model that lead to high estimates of the 1-in-10 year 21-day and 60-day average EECs in water and sediment that are evidenced by relatively modest decreases from their peak values.  This translates into more conservative estimates of chronic risk to aquatic organisms inhabiting both the water column and the benthic zone.  The taxa that are implicated the most by these conservative estimates of chronic exposure are estuarine/marine fish and freshwater and estuarine/marine sediment invertebrates.  Registrant submitted data for these three taxa yielded non-definitive (i.e. "<") NOAECs and therefore the estimated RQ is only a lower bound estimate of risk (i.e. ">").  It is an uncertainty of how much higher than the estimated lower bound RQ that the actual unbounded RQ falls but more refined estimates of chronic exposure would likely mitigate some of this uncertainty by driving the current unbounded estimates of chronic risk further down away from the chronic LOC.

         2. USE CHARACTERIZATION

V-10135 4 SC Fungicide (43.6 percent fenpyrazamine a.i., 56.4% inert ingredients) suspension concentrate is being proposed for aerial and ground foliar applications on almonds, grapes, lettuce, and strawberries for major food crop uses as well as on ornamentals (greenhouse and nursery) as the only major non-food crop use.  Additional IR-4 minor crop uses are proposed for conventional ground and aerial foliar applications on pistachio, bushberry, caneberry, and ginseng crops.  Proposed maximum application rates of fenpyrazamine range between 0.375 lbs. a.i./A  -  1.089 lbs. a.i./A with three to four treatments, at a minimum of 7 seven days between applications specified on the proposed product label.  Table 1 summarizes the labeling for the proposed uses of fenpyrazamine.




Table 1.  Summary use information for fenpyrazamine, based on the proposed V-10135 4 SC Fungicide suspension concentrate label by Valent U.S.A.
                                   CROP USE
                               REGULATORY ACTION
                          MAX. SINGLE APP. RATE     
                                 (lbs. a.i./A)
              MAX. NUMBER OF APPS. and MIN. RETREATMENT INTERVAL
                              SEASONAL APP. RATE
                               (lbs. a.i./A) [5]
                             APPLICATION METHOD 2
                                    Almonds
                                    Sec. 3
                                     0.375
                             3 apps., 7 days apart
                                     1.125
                                     G, A
                                    Grapes
                                    Sec. 3
                                      0.5
                             3 apps., 7 days apart
                                      1.5
                                     G, A
                                    Lettuce
                                       
                                       
                                       
                                       
                                       
                                 Strawberries
                                    Sec. 3
                                      0.5
                             4 apps., 7 days apart
                                      2.0
                                     G, A
                                  Ornamentals
                                    Sec. 3
                                   1.089[1]
                             3 apps., 7 days apart
                                     3.267
                                     G, A
                                  Pistachios
                                     IR-4
                                     0.375
                             3 apps., 7 days apart
                                     1.125
                                     G, A
                                Bushberries[3]
                                     IR-4
                                      0.5
                             3 apps., 7 days apart
                                      1.5
                                     G, A
                                Caneberries[4]
                                       
                                       
                                       
                                       
                                      * 
                                    Ginseng
                                     IR-4
                                      0.5
                             4 apps., 7 days apart
                                      2.0
                                     G, A
[1.] Maximum application rate based on a rate of 0.5lbs./100 gal specified on the label.  According to the label, 100 gallons of spray solution treats 20,000 square feet.  Therefore, 0.5 lbs./20,000 ft.[2] is equivalent to 1.089 lbs./A.
[2]	Application method identifiers:  G = Foliar ground spray/spray chemigation; A = Foliar Aerial Spray
[3]	Bushberries include aronia berry, blueberry, highbush and lowbush, buffalo currant, Chilean guava, cranberry, highbush, black currant, red currant, elderberry, European barberry, gooseberry, edible honeysuckle, huckleberry, jostaberry, juneberry, lingonberry, native currant, salal, sea buckthorn, and cultivars.
[4]	Caneberries include blackberry, logan berry, raspberry, wild raspberry, and cultivars.
[5]	Seasonal application rate specified on label except for ornamentals.  Seasonal application rate for ornamentals assumed based on maximum number or applications specified on label.

         3. ENVIRONMENTAL FATE AND TRANSPORT CHARACTERIZATION

Physical and chemical properties of fenpyrazamine are shown in Table 2 below.  Environmental fate and transport properties of fenpyrazamine based upon registrant submitted studies or other references are shown in Table 3 below.  Since fenpyrazamine is moderately mobile and soluble, fenpyrazamine applied to crops has the capability of being translocated to nearby water bodies via residues dissolving in runoff water.  In addition, fenpyrazamine may also sorb to soil and therefore may reach nearby water bodies via erosion.  Hydrolysis appears to mediate the overall degradation of fenpyrazamine in soil and water as it declines faster in alkaline environments rather than acidic environments.


Table 2.  Physical and chemical properties of fenpyrazamine.
                                   Property
                                Value and units
                                MRID or Source
                                   Structure
                                      \s
                                 MRID 48399915
                                Chemical Class
                        Pyrazole Carboxamide Fungicide
                            http://www.alanwood.net
                               Chemical Formula
                                  C17H21N3O2S
                                 MRID 48399915
                               Molecular Weight
                                  331.4 g/mol
                                 MRID 48399915
                                Vapor Pressure
                                    (25°C)
                             2.17 x 10[-][10] torr
                                 MRID 48399916
                          Henry's Law Constant [1]
                        2.28 x 10[-][10] atm·m[3]/mol
                                   EpiSuite 
                               HENRYWIN v. 3.20
                               Water Solubility 
                                 (pH 7, 20°C)
                                   20.4 mg/L
                                 MRID 48399915
                   Octanol  -  water partition coefficient 
                                   (log KOW)
                                     3.52
                                 MRID 48399914

Table 3.  Summary of fenpyrazamine environmental fate properties.
                                       
                          Study/ OCSPP Guideline No.
                                       
                                Value and unit
                                       
                                       
                              MRID # or Citation
                                       
                         Study Classification, Comment
                              Abiotic Hydrolysis
                                       
                                  (835.2120)

pH4:  Stable (Low levels of degradation observed)
pH7:  Environmentally relevant half-lives could not be determined, but qualitative useful information was obtained.
pH9:  10.9 days

                                   48399923
                                 Supplemental
                                       
Data for pH7, 25°C not provided


Degradates observed:  S-2188-OH at pH 4, pH7, and pH9; and S-2188-DC at pH7 and pH9.
                              Aqueous Photolysis
                                       
                                  (835.2240)
t (1/2) = 1.64 days (SFO)
pH 6.90  -  6.96 (neutral)
                                   48399924
                                  Acceptable
                                       
Environmentally relevant half-life, corrected for dark control

Complete formation and decline of degradates could not be established
                                       
                                Soil Photolysis
                                       
                                  (835.2410)
UK SiL (alkaline, pH 6.9):  t (1/2)   81.05 days (SFO)
                                       
                                       
                                       
                                       
                                   48399926
                                       
                                       
                                       
                                       
                                 Supplemental
                                       
Data showing representativeness of foreign soil to domestic soil (e.g., taxonomic classification) not provided
      
Environmentally relevant half-life, corrected for dark control

                              Degradation in air
                                       
                                  (835.2370)
Reaction with Hydroxyl Radicals
t (1/2) = 0.102 days

Reaction with Ozone
t (1/2) = 0.347 days
                                   EpiSuite
                                AopWin v. 1.92
                               Estimated values
                            Aerobic Soil Metabolism
                                       
                                  (835.4100)
UK SL (alkaline, pH 7.5):  t (1/2) = 49.3 days (DFOP)
UK SL (acidic, pH 5.2):  t (1/2) = 801 days (IORE)
UK L (alkaline, pH 7.9):  t (1/2) = 37.7 days (IORE)
UK SiL (acidic, pH 6.9):  t (1/2) = 230 days (DFOP)








NJ SiL (acidic, pH 6.3):  t (1/2) = 201 days (IORE)




                                   48399920
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                   48399927
                                       
                                       
                                       
                                       
                                  Supplemental
      
Data showing representativeness of foreign soil to domestic soil (e.g., taxonomic classification) not provided
      
      
      
      
                                 Supplemental
                                       
Soil moisture levels throughout study not reported
                           Anaerobic Soil Metabolism
                                       
                                  (835.4200)
NJ SiL (acidic, pH 6.8):  t (1/2) = 128 days (SFO)
                                   48399928
                                  Acceptable
                                       
Complete formation and decline of degradates could not be established

                          Aerobic Aquatic Metabolism
                                       
                                  (835.4300)
UK Silty Clay Loam Sediment:  t (1/2) = 18.9 days (SFO)
(alkaline water pH7.3  -  8.0, acidic sediment pH 6.5  -  6.6 )	
Swiss Lake Sand Sediment: :  t (1/2) = 280 days (IORE)	 (acidic water pH 6.0  -  6.36, alkaline sediment pH 7.5)
                                   48399929
                                 Acceptable[4]

pH initial values in study

Complete formation and decline of degradates could not be established

                         Anaerobic Aquatic Metabolism
                                       
                                  (835.4400)
MS Clay Sediment:  t (1/2) = 12.2 days (SFO)
(alkaline water, pH 8.3, acidic sediment pH 6.9,
                                   48399930
                                 Acceptable[5]

pH initial values in study

Complete formation and decline of degradates could not be established

                    Mobility, unaged leaching, adsorption/
                                  desorption 
                                       
                                  (835.1220)
UK CL:  Koc = 250 mL/g; Kd = 8.7 mL/g; 
	OC = 4.8%; pH8.0
UK SiL:  Koc = 343 mL/g; Kd = 7.4 mL/g;  
	OC = 2.7%; pH7.0
UK L:  Koc = 123 mL/g; Kd = 4.2 mL/g; 
	OC = 3.8%; pH6.0
UK LS:  Koc = 766 mL/g; Kd = 5.7 mL/g ; 
	OC = 0.8 %; pH5.1
Japan SL:  Koc =269 mL/g; Kd = 6.6 mL/g ; 
	OC = 3.2 %; pH5.9




NJ SiL:  Koc = 366 mL/g;  Kd = 3.5 mL/g ; 
	OC = 1.4%; pH6.3 
CA LS:  Koc = 585 mL/g; Kd = 0.87 mL/g ;  
	OC = 0.2%; pH7.5



                                   48399919
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                   48399922
                                       
                                       
                                       
                                       
                                 Supplemental
                                       
Data showing representativeness of foreign soil to domestic soil (e.g., taxonomic classification) not provided








                                 Supplemental
                                       
Only 4 test concentrations used in study
                         Terrestrial Field Dissipation
                                       
                                  (835.6100)
CA SL (neutral, pH 6.4  -  7.1):  t (1/2) = 9.68 days (IORE)
CA LS (neutral, pH 5.7 -7.3):  t (1/2) = 7.68 days (IORE)
ID L (neutral, pH 6.7  -  7.7):  t (1/2) = 7.30 days (IORE)
NY S (neutral, pH 6.4  -  6.7):  t (1/2) = 24.3 days (IORE)
                                   48399931
                                   48399932
                                   48399933
                                   48399934
                                  Acceptable
                                  Acceptable
                                  Acceptable
                                  Acceptable
                                Fish Bioconcen
                             -tration Factor (BCF)
                                       
                                  (850.1730)
Bluegill Sunfish Edible Tissues
Steady State BCF = 7 L/kg
Fenpyrazamine accounted for <1 percent of total radioactive residues after a depuration period of 14 days.
Bluegill Sunfish Non-Edible Tissues
Steady State BCF = 10 L/kg
Fenpyrazamine accounted for <1 percent of total radioactive residues during depuration phase.
Bluegill Sunfish Whole Fish Tissues
Steady State BCF = 9 L/kg
Fenpyrazamine accounted for <1 percent of total radioactive residues during depuration phase.
                                   48400005
                                  Acceptable
                                     Env.
                                   Chemistry
                                    Method
                                     (ECM)
                             Water (Tap and Pond)
                    Mean Recoveries 85  -  93%; RSD 4 - 11
                                       
                                 Water (Well)
               Mean Recoveries 81.2  -  102%; RSD 3.53  -  18.8
                                       
                                     Soil
                    Mean Recoveries:  87%; RSD 2.3  -  2.9 
                                   48399918
                                       
                                       
                                   48400034
                                       
                                       
                                   48400026
                                       
                                  Acceptable
                                  Independent
                                  Laboratory
                                  Validation
                                     (ILV)
                                 Water (Well)
               Mean Recoveries 103  -  94.6%; RSD 2.34  -  2.62
                                       
                                     Soil
                Mean Recoveries:  89.4% -90.9%; RSD 6.5  -  8.4
                                   48400034
                                       
                                       
                                   48400026
                                       
                                  Acceptable
                               Storage Stability
                                     Soil

                      Normalized/Corrected Mean Recovery:
                    100  -  122.1 percent (Days 0  -  366)


                                   48399921
                                  Acceptable
[1]  NA means not applicable.
[2]  Half life degradation kinetics scheme determinations:
 SFO = Single First Order, IORE = Indeterminate Order Rate Equation, DFOP = Double First Order in Parallel
Kinetic models and representative half-lives were determined in agreement with the "Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media" (2011), accessed 09/27/12 at http://www.epa.gov/oppfead1/international/naftatwg/guidance/guidance.htm .
3  Soil textural classifications:
	S:  Sand
	SL:  Sandy Loam
	LS:  Loamy Sand
	SiL:  Silt Loam
	L:  Loam
      CL: Clay Loam 
4  Although the study is acceptable, there are still uncertainties related to the variations in biodegradation versus possible mediation from hydrolysis that is evident from the data.  Please refer to the uncertainties and limitations section at the end of this chapter, Section 7.2.6.b, and Section 8 for further details.
5  Although the study is acceptable, there is still a data gap since only one water-sediment system was evaluated.  Please refer to the uncertainties and limitations section at the end of this chapter, Section 7.2.6.b, and Section 8 for further details.
      
   * Fenpyrazamine Mobility and Transport to Water Bodies

Given foliar applications of fenpyrazamine, residues may be deposited into soil via washoff from rainfall or irrigation activities as well as directly deposited onto soil during the application.  Fenpyrazamine may reach surface water bodies or ground water given its solubility of 20.4 mg/L at 20°C (indicating that fenpyrazamine is highly soluble) (MRID No. 48399915) and Kd values ranging between 0.87  - 8.7 mL/g (indicating that fenpyrazamine is slightly to moderately mobile in soil)(MRID Nos. 48399919 and 48399922). It appears that sorption of fenpyrazamine is not well correlated to organic carbon content given the weak relationship between soil-water partition coefficients and organic carbon content collectively among soils.  Fenpyrazamine's properties are common to other pesticides that are known to dissolve in runoff water to reach surface water bodies and leach to ground water.  Furthermore, fenpyrazamine residues may also reach surface water bodies via erosion as its range of Kd values suggests that residues may bind to soil particles to a certain extent.  Fenpyrazamine is not expected to escape from dry or moist soil surfaces or water bodies to the air via volatilization given its low vapor pressure value of 2.17 x 10[-10] torr (at 25°C) (MRID No. 4833906) and low Henry's Law Constant of 2.28 x 10[-10] atm·m[3]/mol (at 25°C) (EpiSuite HENRYWIN v. 3.20).

   * Degradation of Fenpyrazamine (S-2188) and Identification of Transformation Products in Soil 
      
Fenpyrazamine appears to be moderately persistent in alkaline soil environments.  Aerobic soil metabolism half-lives range between 37.7 and 49.3 days, respectively under alkaline conditions (MRID No. 48399920).  Although no sterile controls were included, it is expected that the biodegradation is supplemented by hydrolysis in alkaline environments.  These half-lives are most similar to the decline (e.g., runoff, leaching, and biodegradation) of fenpyrazamine observed in terrestrial field dissipation studies conducted in neutral soils in California (2 sites), Idaho (1 site), and New York (1 site) with total soil profile (including depths below the runoff extraction zone) half lives observed between 7.3 and 24.1 days (MRID Nos. 48399931, 48399932, 48399933, and 48399934).  Fenpyrazamine appears to be persistent in acidic soils with half-lives between 201  -  801 days as observed in aerobic soil metabolism studies (MRID Nos. 48399920, and 48399927)  In anaerobic acidic soil environments, half-lives are a little less at 128 days in NJ Silt Loam Soil (MRID No. 48399928).  There are no studies available for anaerobic soil alkaline environments.  There are also no field dissipation studies conducted in acidic environments.  Soil photolysis appears to be a minor degradation pathway with a half-life of 104 day in NJ Silt Loam Soil (MRID No. 48399926).

In alkaline aerobic soil metabolism studies (MRID No. 48399920)[5], the degradate S-2188-OH forms at levels of between 0.8 percent  -  2.7 percent of applied radioactivity (See Appendix F for a more detailed summarization of the degradates formed, their structures and at what percentages result).  For alkaline conditions, the degradate S-2188-DC forms at levels between 0.5  -  2.8 percent of applied radioactivity in aerobic soil metabolism studies (MRID Nos. 48399920 and 48399923).  In general, degradates were not observed to form to significant levels in the aerobic soil metabolism studies.   The likely mechanism of dissipation is due to incorporation into soil organic matter as evidenced by large levels of unextracted residues, accounting for approximately up to 70 percent of the material balance in two alkaline soils in aerobic soil metabolism studies (MRID No. 48399920)[5][,].  The identity of the unextracted residues (whether they consist of parent or metabolite residues) is not certain since both parent and degradates are moderately mobile as evident from partition coefficients shown ahead in Table 4.  Furthermore, the Koc values of degradates range between 123  -  1,704 mL/g, indicating a moderate tendency for residues to partition to soil much like fenpyrazamine.  It is not expected that unextracted residues incorporated in eroded soil layers which become sediment in water bodies will desorb into the water column as demonstrated by the exhaustive extraction procedures used in the laboratory studies.  This tendency has also been observed in the batch equilibrium studies (MRID No. 48399919) as less than 32 percent of residues were observed to desorb into the water column for all soils evaluated.

Based upon the information described above from the environmental fate laboratory studies, the degradation pathway for the terrestrial (soil) environment is presented in Figure 1 below.


Incorporated Residues to Soil Layer
	

Figure 1.  Proposed degradation and dissipation pathways in soil.

   * Degradation of Fenpyrazamine (S-2188) and Identification of Transformation Products in Water

Upon reaching water bodies, aqueous photolysis is expected to be the main degradation mechanism for fenpyrazamine in reservoir surface waters, with a half-life of 1.64 days (corrected for environmentally relevant conditions).  The degradates S-2188-DC and MCNI formed to significant levels of 65.6 and 19.9 percent of the applied, respectively.  Hydrolysis is also expected to be a key degradation pathway particularly in alkaline environments.  However, some degradation is evident in acidic, neutral, and alkaline environments with formation of the degradate S-2188-OH observed at pH4, pH7, and pH9; and S-2188-DC observed at pH7 and pH9.  An environmentally relevant hydrolysis half-lives of 10.9 days has been determined at pH9.  Fenpyrazamine is stable at pH4, although a very small amount of the degradate S-2188-OH was detected.  No environmentally relevant half-life at pH7 is available.  This deficiency is described in Table 3 and in the Uncertainties and Limitations section before the conclusion of this chapter.

Fenpyrazamine degrades at a moderate rate in aerobic alkaline environments with a half life of 18.9 days as indicated in an alkaline aerobic aquatic metabolism study for the Calwich Abbey, UK lake water- silty clay loam sediment system (MRID No. 48399929).  Although no sterile controls were included, it is expected that the biodegradation is supplemented by hydrolysis in alkaline environments.  In aerobic aquatic acidic environments, fenpyrazamine degrades much slower with a half life of 280 days in a Swiss lake  -  sand sediment system (MRID No. 48399929).  In anaerobic acidic aquatic environments, fenpyrazamine is moderately persistent with a half-life of 12.2 days in a Mississippi Creek  - clay sediment system (MRID No. 48399930).  

In aerobic alkaline aquatic environments, the S-2188-OH and S-2188-DC degradates form in significant quantities encompassing up to 17.3 and 23.5 percent of the applied, respectively, in the Calwich Abbey, UK Lake  -  silty clay loam sediment system (MRID No. 48399929).  Like for aerobic soils, there are significant quantities of unextractable residues observed.  Unextracted residues in the Calwich Abbey, UK lake-silty clay loam sediment system accounted for up to 48.4 percent of the applied.  Therefore, the unidentified unextracted residues accounted for in aerobic aquatic metabolism studies for alkaline systems may comprise of additional levels of fenpyrazamine, S-2188-OH, and S-2188-DC degradates.  Likewise from soil, it is not expected that these residues will be bioavailable in the aquatic compartment of water bodies since residues remained incorporated in sediment after exhaustive extraction techniques in the study were employed.  

Based upon the information described above from the environmental fate laboratory studies, the degradation pathway for aquatic environment is presented in Figure 2 below.


                                       
                                       
                                       
                             Incorporated Residues to Sediment Layer
.

Figure 2.  Proposed degradation and dissipation pathways in water.

   * Bioconcentration of Fenpyrazamine and Degradate Residues in Fish

Steady-state BCF values in fish between 7 -10 L/kg from edible tissues, non-edible tissues, and whole fish indicate that bioaccumulation potential of fenpyrazamine residues is low (MRID No. 48400005).  In addition, depuration of fenpyrazamine is negligible and fish tissue metabolism is high, since in the uptake phase, fenpyrazamine is transformed rapidly to S-2188-DC and S-2188-DC conjugate.  In the depuration phase, the major degradates that remained in edible fish tissue included S-2188-DC and the S-2188-DC conjugate which existed at maximum levels of 16.2 percent and 42 percent of total radioactive residues, respectively.  The depuration rates are rapid among the degradates.  The depuration half-life of the S-2188-DC degradate is 1.74 days and the S-2188-DC Conjugate is 10.1 days (MRID No. 48400005)[7].  Therefore, given the high metabolism of fenpyrazamine evident in fish and high depuration rates of the degradates, bioaccumulation in fish resulting from fenpyrazamine pesticide applications is not a concern.  

   * Fate and Transport Characteristics of Transformation Products

The formation of all fenpyrazamine degradates in soil and water which form due to abiotic processes and biodegradation is shown in Appendix F.  The properties of the degradates of fenpyrazamine which form in soil and water are shown in Table 4 below.  Fenpyrazamine appears to be less mobile than its degradates as it is less soluble.  However, despite this difference, fenpyrazamine and its degradates all possess solubility values in the same range of pesticides which both dissolve in runoff water and partition to soils and sediments.  In addition, the log Koc values of degradates range between 2.20  -  3.67 indicating that they are slightly to moderately mobile based on the FAO classification scheme.  The Kd values of fenpyrazamine between 3.5 mL/g  -  8.7 mL/g (with one soil with a Kd value of 0.87 mL/g, see Table 3) further suggests that fenpyrazamine possesses mobility characteristics corresponding to the lower end of the range of that encompassing the degradates.  Fenpyrazamine's Koc values is not a valid model for comparison since its sorption is not highly correlated with organic carbon content.  

Table 4.  Comparison of physical chemical properties of fenpyrazamine transformation products to parent fenpyrazamine.
                                   Property/
                          EPISuite Estimator Program 
                         Value from Product Chemistry
                           EpiSuite Estimated Value
                                       
                                 Fenpyrazamine
                                   (S-2188)
                                   S-2188-OH
                                   S-2188-DC
                                  S-2188-DTC
                                     MCNI
                                       
                                     MPZZ
Molecular Weight
                                  331.4 g/mol
                                  247.3 g/mol
                                  231.3 g/mol
                                  271.4 g/mol
                                  216.3 g/mol
                                  189.2 g/mol
Solubility in Water 
(25 °C)
(WSKOWWIN v. 1.42)
                                 20.4 mg/L[a]
                                  5,019 mg/L
                                  938.2 mg/L
                                  1,437 mg/L
                                  107.7 mg/L
                                 246,400 mg/L
Vapor Pressure 
(25 °C)
(MPBPVP v. 1.43)
                            2.17 x 10[-10] torr[b]
                              2.66 x 10[-7] torr
                             2.87 x 10[-][7] torr
                              8.85 x 10[-8] torr
                              6.23 x 10[-7] torr
                              3.75 X 10[-6] torr
Henry's Law Constant (25 °C)
(HENRYWIN v. 3.20)
                        2.28 x 10[-10] atm·m[3]/mol[c]
                      7.30 x 10[-][13] atm·m[3]/mol[c] 
                         9.31 x 10-11 atm·m[3]/mol[c]
                        2.20 x 10[-11] atm·m[3]/mol[c]
                        1.65 x 10[-9] atm·m[3]/mol[c]
                        4.23x 10[-10] atm·m[3]/mol[c]
Octanol-Water Partition Coefficient 
(Log Kow)
(WSKOWWIN v. 1.42)
                                    3.52[d]
                                     0.81
                                     0.23
                                     1.28
                                     2.65
                                     0.38
Soil-Water Partition Coefficient (Koc)
(KOCWIN v. 2.00)
                                    N/A[e]
                                  158.6 mL/g
                                  1,302 mL/g
                                  4,633 mL/g
                                  428.1 mL/g
                                  1,704 mL/g
*Only degradates found in environmental fate laboratory and field studies in soil and water are shown in table.
[a]  Value at 20°C from MRID No. 4839915.
[b]  From MRID No. 48399916.
[c]  From EpiSuite HENRYWIN v. 3.20.
[d]  From MRID No. 48399914.
e  N/A means not available since Koc is not a good measure or sorption to soil or sediment..

The degradation half-lives of the transformation products for fenpyrazamine cannot be determined at this time based on the existing data from laboratory studies (see Table 3 for further information).  The durations of environmental fate studies were insufficient to determine the complete formation and decline rates of the degradates which are needed to complete this analysis.  This information has not been found upon inspection of open literature nor have data been identified among common degradates from existing active ingredients.  However, the maximum formations of degradates detected in environmental fate laboratory and field studies can be found in Appendix F..

   * Uncertainties and Limitations

There are several significant uncertainties with the environmental fate profile of fenpyrazamine. 
The first major uncertainty concerns fenpyrazamine's rate of hydrolysis in the environment.  The existing hydrolysis study suggests that fenpyrazamine degrades over all environments, especially in alkaline environments, with metabolites S-2188-OH and S-2188-DC detected (MRID No. 48399923).  This is also evident from the aerobic aquatic metabolism study (MRID No. 48399929), which also shows a trend of decreased half-lives at higher pHs, suggesting that hydrolysis mediates degradation in alkaline environments.  However, environmentally relevant hydrolysis data at 25°C were not provided to the Agency for neutral environments (pH7),  including the rate of degradation as well as the levels of the transformation products for fenpyrazamine.  Additional hydrolysis information would confirm the rate of degradation, as well as the levels of the transformation products of fenpyrazamine at pH7 and 25°C at environmentally relevant conditions.

A second significant uncertainty relates to the limited sediment - water systems evaluated in the anaerobic aquatic study (MRID No. 48399930).  Only one system was evaluated in each study.  Additional water  -  sediment systems would provide a sufficiently robust dataset showing the distribution of microbial degradation.  

 A third uncertainty regards unextracted residues incorporated in soil or sediment layers.  In soil, unextracted residues accounted for approximately up to 70 percent of applied in two alkaline soils in aerobic soil metabolism studies (MRID No. 48399920).  In water, unextracted residues in sediment from the Calwich Abbey, UK study sample accounted for up to 48.4 percent of applied.  It should be noted that unextracted residues are likely bonded chemically to the humin matrices within the soil and sediment layers.  Soil-water partition coefficients of fenpyrazamine and degradates as well as inconsistencies in the amount of unextracted residues between the aerobic and anaerobic aquatic metabolism studies suggest that unextracted residues are not forming due to sorbtion of  fenpyrazamine.
 
 A fourth uncertainty which exists is that water-sediment systems with variable pHs were evaluated in the aerobic aquatic metabolism study.  Since degradation is much different between acidic and alkaline conditions, it appears that degradation is mediated pH.  
 
The fifth uncertainty concerns the little availability of batch equilibrium studies conducted on domestically representative soils. The organic-carbon normalized partition coefficient (Koc) were only examined for a loamy sand soil from California and a silt loam soil from New Jersey (MRID No. 48399922).  The remaining soils were evaluated from the UK and Japan (MRID No. 48399919).  The UK soils are traditionally similar to the physical and chemical composition of soils in the United States.  However, soils in Japan traditionally possess volcanic elements which are found over very limited areas in the United States.  However, data that are available for five other foreign soils in the UK appear to confirm the moderate mobility of fenpyrazamine observed in the domestic soils.  Additional information on the taxonomic properties of the foreign soils would confirm their representativeness to US soils.
 




         2. ECOLOGICAL TOXICITY CHARACTERIZATION

         4.1 Receptors

 Ecological measures of effect for this screening level risk assessment are based on a suite of registrant-submitted toxicity studies performed on a limited number of organisms in broad groupings.  Table 5 gives examples of taxonomic groups and test species evaluated for ecological effects in this screening level risk assessment.  Within each of these very broad taxonomic groups, an acute and/or chronic endpoint is selected from the available test data (see Table 6).   
 
Table 5.  Taxonomic groups and test species evaluated for ecological effects in this screening-level risk assessment
 Taxonomic group
 Representative species
 Birds [a]
 Mallard duck (Anas platyrhynchos)
 Bobwhite quail (Colinus virginianus)
 Canary (Serenris canaria)
 Mammals
 Laboratory rat (Rattus norvegicus)
 Terrestrial Invertebrates
Honey bee (Apis mellifera)
Earthworm (Eisenia fetida)
 Freshwater fish [b]
Bluegill sunfish (Lepomis macrochirus)
Rainbow trout (Oncorhynchus mykiss)
Freshwater Invertebrates
Water flea (Daphnia magna)
Estuarine/marine Fish
Sheepshead minnow (Cyprinodon variegatus)
Estuarine/marine Invertebrates
Mysid shrimp (Americamysis bahia), Eastern oyster (Crassostrea virginica)
Benthic Freshwater Invertebrates
Amphipod (Hyalella azteca)
Freshwater midge (Chironomus riparius)
Benthic Estuarine/Marine Invertebrates
Amphipod (Leptocheirus plumulosus)
Aquatic Plants and Algae
Duckweed (Lemna gibba)
Green algae (Pseudokirchneriella subcapitata)
Marine diatom (Skeletonema costatum)
Freshwater diatom (Navicula pelliculosa)
Cyanobacteria (Anabaena flos-aquae)
Terrestrial Plants
Multiple species
[a] Birds may be surrogates for amphibians (terrestrial phase) and reptiles.
[b] Freshwater fish may be surrogates for aquatic phase amphibians.
 
For screening risk assessments, the following toxicity endpoints presented in Table 6 are used as inputs to the risk quotient (RQ) method for expressing risk (US EPA, 2004).  Details of the risk quotient method and its associated LOCs are found in Appendix A.  The designation of "listed species" refers to either federally threatened or endangered species.


Table 6.  Toxicity endpoints used in risk quotient calculations.
 Taxonomic group
 Representative species
Aquatic Animals
Acute assessment 


Chronic assessment 


Lowest tested EC50 or LC50 for freshwater fish and invertebrates and estuarine/marine fish and invertebrates acute toxicity tests.

Lowest no-observed-adverse-effects- concentration (NOAEC) for freshwater fish and invertebrates and estuarine/marine fish and invertebrates early life-stage tests.
Terrestrial Animals 
Acute avian assessment 

Chronic avian assessment 

Acute mammalian assessment 

Chronic mammalian assessment 

 

Lowest LD50 (single oral dose) and LC50 (subacute dietary).

Lowest NOAEC for 21-week avian reproduction test.

Lowest LD50 from single oral dose test. 

Lowest NOAEC for two-generation reproduction test or chronic dietary study
Plants
Terrestrial non-listed species 


Aquatic vascular and algae

Terrestrial listed species 

Lowest EC25 values from both seedling emergence and vegetative vigor for both monocots and dicots. 

Lowest EC50 for both aquatic vascular plants and algae.

Lowest EC05 or NOAEC for both seedling emergence and vegetative vigor for both monocots and dicots. 
 [a] Freshwater fish may be surrogates for amphibians (aquatic phase).
 [b] Birds may be surrogates for amphibians (terrestrial phase) and reptiles.
 
 Acute and chronic laboratory and field tests on fenpyrazamine on aquatic organisms provide information regarding lethality, as well as sublethal measures of effect.  Data are available on the technical grade active ingredient (TGAI) and the effects on freshwater and estuarine/marine fish and invertebrates, aquatic vascular and nonvascular plants (algae), and freshwater and estuarine/marine sediment dwelling organisms.  Additionally acute toxicity data were available for certain degradation/transformation products of fenpyrazamine on rainbow trout, daphnia magna, and freshwater green algae.  These studies will be discussed with the other toxicity data in Section 4.4 of this assessment.
 
 For terrestrial effects, registrant-submitted studies on fenpyrazamine technical are available for acute, subacute dietary, and chronic exposure to birds, and acute and chronic exposure to mammals.  Additional ecological effects data for fenpyrazamine are available for honey bees and earthworms.  Finally, data on the effects of seedling emergence and vegetative vigor for ten species were submitted in support of fenpyrazamine. 
 
         4.1 Ecosystems at Risk  
 
 The ecosystems at potential risk from the proposed uses of fenpyrazamine are extensive in scope due to the wide geographic distribution of potential fenpyrazamine application sites.  In general, terrestrial ecosystems potentially at risk could include the treatment areas directly and adjacent areas that may receive spray drift and/or runoff.  This could include the treatment area itself as well as 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 treatment area and might include impounded bodies such as ponds, lakes, reservoirs and wetland areas, or flowing waterways such as streams and rivers. For uses in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries and salt marshes.  Additionally freshwater and estuarine/marine benthic zones are at potential risk due to fenpyrazamine's moderate persistence and mobility suggesting its potential to translocate and reside in water bodies.
 
         4.1 Assessment Endpoints  
 
 Assessment endpoints represent the actual environmental value that is to be protected, defined by an ecological entity (species, community, or other entity) and its attribute or characteristics (US EPA, 1998).    For the proposed fenpyrazamine uses, the ecological entities may include the following:  birds, mammals, freshwater fish and invertebrates, estuarine/marine fish and invertebrates (pelagic and benthic dwelling), insects, and aquatic and terrestrial plants. The attributes for each of these entities may include growth, reproduction, survival, biomass (standing crop for plants). For both aquatic and terrestrial animal species, direct acute and direct chronic effects are considered.  Although these endpoints are measured at the individual level, they provide insight about risks at higher levels of biological organization (such as populations and communities).  

         4.1 Ecological Effects Characterization 
 
 The effects of fenpyrazamine on aquatic and terrestrial organisms as derived from laboratory studies are summarized in this section.  It is important to recognize that the toxicity test results reported herein represent a small fraction of avian, mammalian, aquatic organisms and plant species resident to North America. Specifically, only a few surrogate species for both freshwater fish and birds are used to represent all freshwater fish (2000+) and bird (680+) species in the United States.  For mammals, acute studies are usually limited to Norway rat or the house mouse.  Estuarine/marine testing is usually limited to a crustacean, a mollusk, and a fish.  Also, neither reptiles nor amphibians are commonly tested.  In the absence of toxicity data for reptiles and terrestrial phase amphibians, this risk assessment uses the sensitivity of birds as a surrogate for terrestrial-phase amphibians and reptiles.  Similarly, freshwater fish are used as a surrogate for aquatic-phase amphibians. 
 
 In general, categories of acute toxicity ranging from "practically nontoxic" to "very highly toxic" have been established for aquatic organisms (based on LC50 and EC50 values or limit of solubility), mammals (based on LD50 values), avian species (based on  LD50 and  LC50 values), and non-target insects (based on LD50 values for honey bees) (U.S. EPA 2001).  
 
 
 
                     4.4.1 Aquatic Effects  
 
The acute and chronic toxicity values associated with freshwater and estuarine/marine species exposure to fenpyrazamine are summarized in Table 7.  Toxicity endpoints shown in bold represent the most sensitive endpoints within a taxonomic grouping (e.g., freshwater fish, freshwater invertebrates, aquatic plants, etc.).  These endpoints are termed the "toxicity reference values" which are used for this quantitative risk assessment.  All acute, chronic, and subchronic exposures to animals as well as exposures to plants are expected given fenpyrazamine's moderate persistence and mobility suggesting its potential to translocate and reside in water bodies.  Studies that were submitted with various degradation products of parent fenpyrazamine are summarized in Table 8.



Table 7.  Toxicity reference values for aquatic organisms exposed to fenpyrazamine. 
                               Exposure Scenario
                                     % A.I.
                                    Species 
                                      Dur.
                           Toxicity Reference Value 
                                    (95% CL)
                                  Effect Notes
                                     MRID;
                             Classifi-cation (Year)
 Freshwater Fish
                                     Acute
                                      TGAI
                                     94.7%
 Rainbow Trout
 Oncorhynchus mykiss
 96 h
 LC50  = 5.2 mg a.i./L (3.8  -  7.8)
 Probit Slope = N/A
 
   * 100% mortality was observed in the highest treatment concentration (7.8 mg a.i/L, mean measured).
   * 5% or less mortality was observed in the controls and remaining treatment concentrations
   * Varying number of fish in the three highest treatment concentrations (2.1, 3.8, and 7.8 mg a.i/L, mean measured) were lethargic
   
                                    48399945
                                   Acceptable
                                     (2006)
                                     Acute
                                      TGAI
                                     94.7%
 Bluegill sunfish (Lepomis macrochirus)
                                      96 h
 LC50  =  5.4 mg ai/L (3.4  -  6.9)
 Probit Slope = N/A
 
   * There was 85 and 100% mortality in the two highest treatment concentrations (6.9 and 12 mg a.i/L mean measured, respectively)
   * 0% mortality occurred in the controls and all other treatment concentrations (0.88, 1.8, and 3.4 mg a.i/L)
   * All fish in highest treatment group exhibited a complete loss of equilibrium after three hours of exposure and were dead by six hours
                              48399944 Acceptable
                                     (2006)
                                    Chronic
                                      TGAI
                                     94.7%
 Rainbow Trout
 (Oncorhynchus mykiss)
                                      90 d
 NOAEC (survival at hatch, survival at test termination) = 370 ug a.i./L
 LOAEC = 750 ug a.i./L
   * Embryo viability averaged 62  -  70% across the controls and all treatment concentrations 
   * Day-0 post hatch survival of larvae ranged from 96  -  100% across the controls and all treatment concentrations
   * Day-60 post hatch survival was significantly reduced at the highest treatment concentration
   * Total length, wet weight, and dry weight were not significantly reduced at any treatment level (highest treatment level excluded from analysis due to effects on survival)
   * 
   * 

                                    48400003
                                   Acceptable
                                     (2006)
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
 Freshwater Invertebrates
                                     Acute
                                      TGAI
                                     94.7%
 Water flea
 Daphnia magna
                                      48 h
 EC50  = 5.5 mg a.i/L (4.6  -  6.5)
 Probit Slope: 10.2 (6.1  -  14.2)
 
   * 0% mortality in negative and solvent control as well as three lowest treatment groups
   *  95% mortality at highest treatment group (8.0 mg a.i/L) 
   * Lethargy among surviving daphnids observed in all treatment groups
                              48399939 Acceptable
                                     (2006)
                                    Chronic
                                      TGAI
                                     94.7%
 Water flea
 Daphnia magna
                                      21 d
 NOAEC: 0.34 mg a.i/L
 LOAEC: 0.76 mg a.i/L
   * There were no treatment related effects on survival
   * Number of offspring released by females was significantly reduced (p<0.05) at the two highest treatment concentrations (0.76 and 1.4 mg a.i/L, mean measured)
   * Body lengths of surviving daphnid were significantly reduced (p<0.05) at the two highest treatment concentrations
   * Dry weights of surviving daphnids were statistically reduced (p<0.05) at the highest treatment concentration only
   * There was a delayed time to first brood compared to the controls at the two highest treatment concentrations (Day 9 at 0.76 mg a.i/L, Day 10 at 1.4 mg a.i/L, compared to Day 7 for controls and all other treatment concentrations
   * Immobilized offspring, if any, were not reported
                              48400001 Acceptable
                                     (2006)
 Estuarine/Marine Fish
                                        
                                        
                                        
                                        
                                     Acute
                                      TGAI
                                     98.8%
 Sheepshead minnow
 (Cyprinodon variegatus)
                                      96 h
 LC50: >3.9 mg ai/L (95% CI N/A)
 Probit Slope: N/A
 
   * 20% mortality occurred in the 3.9 mg a.i/L treatment concentration (mean measured), the highest treatment concentration
   * There was no mortality in the negative control or any other treatment concentration
   * There were no clinical signs of toxicity or sublethal effects observed in the negative control or any treatment concentrations except the highest in which several surviving fish were lethargic, and two surviving fish exhibited a partial loss of equilibrium.
                                    48399946
                                   Acceptable
                                     (2010)
                                    Chronic
 TGAI 98.8%
 Sheepshead minnow
 (Cyprinodon variegatus)
 33 d
 NOAEC (length) = <0.039 mg a.i/L
 LOAEC (length) = 0.039 mg a.i/L
   * No treatment-related effects on hatching success or post hatch larval survival were observed
   * Statistically significant (p<0.05) effects on length observed at all treatment concentrations
   * Dry weight effects were statistically significant (P,0.05) at the two highest treatment concentrations (0.58 and 1.2 mg a.i/L)
   * Time to hatch and clinical signs of toxicity (if any) were not reported
  
                                    48400004
                                  Supplemental
                                     (2010)
 Estuarine/Marine Invertebrates
                                                                               
                                                                               
                                                                               
                                     Acute
                                      TGAI
                                     98.8%
 Saltwater mysid (Americamysis bahia)
                                      96 h
 LC50 = 0.83 mg ai/L (0.62  -  1.2)
 Probit Slope: N/A
 
   * 100% mortality occurred at three highest treatment concentrations (1.2, 2.3, and 4.6 mg a.i/L, mean measured)
   *  All mysids in the control and lowest treatment concentration (0.29 mg a.i/L, mean measured) appeared normal and healthy throughout the study





                                    48399941
                                   Acceptable
                                     (2010)
                                                                               
                                      TGAI
                                     98.8%
 Eastern Oyster (Crassostrea virginica)
                                      96 h
 EC50 = 0.78 mg ai/L (0.58  -  1.1 mg ai/L)
 NOAEC= 0.49 mg ai/L
   * Shell growth was reduced by 30.4, 21.7, 21.7, 30.4, and 73.9 relative to controls at 0.066, 0.12, 0.24, 0.49, and 1.0 mg ai/L, respectively (mean measured).
                                    48399940
                                   Acceptable
                                     (2010)
                                                                               
                                                                               
                                                                               
                                    Chronic
                                      TGAI
                                     98.8%
 Saltwater mysid (Americamysis bahia)
                                      38 d
 NOAEC = 98 ug a.i./L  
 LOAEC50 = > 98 ug a.i./L  
 
 
   * Mysids exposed to control, 3.2, 6.8, 13, 24, 47, and 98 ug a.i/L mean measured treatment concentrations
   * There were no significant reductions (p<0.05) for time to first brood release, F0 survival, F1 survival, male and female dry weight, and male total body length
   * While there was a significant reduction at the lowest treatment concentration for number of offspring per female, this was the only treatment concentration affected
   * Female total body length was significantly (p<0.05) reduced at the lowest and two highest treatment concentration yet their percent effect as compared to the negative control were between 2.5  - 5.3%.  As the effect did not follow a dose response pattern and was not considered to be biologically significant, the NOAEC was determined as the highest treatment concentration
                                    48400002
                                   Acceptable
                                     (2010)
 Freshwater Benthic Invertebrates
                                    Chronic
                                      TGAI
                                     98.8%
 Freshwater amphipod, (Hyalella azteca)
                                      42 d
 Sediment value: NOAEC (35-d survival and reproduction, 42-d survival) =5.7 mg a.i./kg dw
 
  Porewater value: NOAEC (35-d survival and reproduction, 42-d survival)  = 0.5 mg a.i/L
   * Mean percent survival after 42 days was 95, 93, 93, 77, 61, 71, and 24 mg a.i/kg sediment for the negative control, solvent control, and time weighted average sediment concentrations of 5.7, 10, 24, 38, and 97 mg a.i/kg sediment levels, respectively
   *  Growth and reproduction data were dropped from analysis for 28-d dry weight, 35-d number of offspring, and 42-d  dry weight, number of offspring, and male to female ratio because of significant effects on survival at these intervals for varying concentrations
                                   48400006
                                   Acceptable
                                     (2010)
 
 TGAI 94.7
 Freshwater midge
 (Chironomus riparius)
 28 d
 Sediment value: NOAEC (development rate) = < 0.101 ug a.i/kg dw
 
 Pore water value:
 NOAEC (development rate) = <0.20 ug a.i/L
   * Test vessels were spiked once via overlying water 
   * Overlying water concentrations decline over time, while pore water and sediment concentrations increased
   * Percent emergence was 75% or greater at all concentrations
   * Definitive NOAEC was not reached for development rate due to effects at lowest treatment level  
                                    48400007
                                  Supplemental
                                     (2009)
 Estuarine/Marine Benthic Invertebrates
                                    Chronic
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                     Acute
                                        
                                      TGAI
                                     98.8%
 Saltwater amphipod
 (Leptocheirus plumulosus)
                                      28 d
 Sediment value: 
 NOAEC/LOAEC = <3.0/6.3 mg a.i/kg dw (dry weight)
 
 Pore water value:
 NOAEC/LOAEC = <0.25/0.5 mg a.i/L  (dry weight)
 
   * Total mortality observed at highest two concentrations (25 and 50 mg a.i/kg sediment
   * Dry weight and number of offspring per female not significantly affected at two lowest treatment levels (3.0 and 6.3 mg a.i/kg sediment).  
                                   48400008
                                  Supplemental
                                     (2010)
 Aquatic Plants
                                Vascular plants
                                                                               
                                      TGAI
                                     98.8%
 Duckweed (Lemna gibba)
                                      7 d
 EC50 (frond weight):  1.1 mg a.i./L (1.2  -  1.8)
 NOAEC (frond weight):  0.60 mg a.i./L 
   * The percent growth inhibition for treatment concentrations compared to the negative control ranged from -11  -  79% based on frond density, 1  -  9% based on frond weight, and 5  -  55% based on day 0  -  7 growth rate
   * Fronds in the two highest treatment concentrations (2.3 and 5.9 mg a.i/L, mean measured) had reduced root development relative to control fronds.
                              48400018 Acceptable
                                     (2010)
                                 Algal toxicity
                                      TGAI
                                     98.8%
Cyanobacteria
(Anabaena flos-aquae)
                                      96 h
 EC50  (cell density): 1.2 mg a.i/L (0.21  -  2.5)
 
 NOAEC (cell density, growth rate, biomass): 0.74 mg a.i/L
 
   * The percent growth inhibition in treatment concentrations compared to the negative control ranged from 12  -  87% based on cell density.  
   
                                    48400024
                                   Acceptable
                                     (2010)
                                        
                                      TGAI
                                     94.7%
Freshwater Green algae 
(Pseudokirchneriella subcaipta)
                                      96 h
 EC50 (cell density): 0.16 mg a.i/L (0.12  -  0.22)
 
 NOAEC (cell density): <0.053 mg a.i/L 
 
 EC05 (cell density): 0.029 mg a.i/L (0.015  -  0.055)*
 
   * The percent growth inhibition in the treatment concentrations compared to the negative control ranged from 26  -  95% based on cell density, 5  -  48% based on growth rate, and 15  -  92% based on biomass.
   * At test termination, cells in the highest treatment concentration (0.9 mg a.i/L, mean measured) were observed to be bloated.
                                    48400021
                                   Acceptable
                                     (2008)
                                 Algal toxicity
                                      TGAI
                                     98.8%
Marine diatom
(Skeletonema costatum)
                                      96 h
 EC50 (cell density): 0.027 mg a.i/L (0.024  -  0.035)
 
 NOAEC (cell density): <0.0045 mg a.i/L
 EC05: 0.002 (95% CI  N/A)*
   * The percent growth inhibition in the treatment concentrations compared to the negative control ranged from 3  -  97% based on cell density, the most sensitive endpoint.
                                   48400022 
                                   Acceptable
                                     (2010)
                                        
                                   TGAI 98.8%
Freshwater diatom
(Navicula pelliculosa)
                                      96 h
 EC50: (cell density): 0.011 mg a.i/L (0.10  -  0.012)
 NOAEC (cell density): 0.0049 mg a.i/L
   * The percent growth inhibition in the treatment concentrations compared to the negative control ranged from -11  -  99% on cell density. 
                                   48400023 
                                   Acceptable
                                     (2010)
*EFED policy is to use the EC05 for estimation of risk to endangered aquatic plant in the event the NOAEC is non-definitive.
Bolded values refer to the most sensitive endpoint for a given taxa to be used in quantitative risk assessment.

Table 8.  Toxicity Reference Values For Aquatic Organisms Exposed to Degradation Products of Fenpyrazamine. 
                              Degradation product
                                     % A.I.
                                    Species 
                                      Dur.
                           Toxicity Reference Value 
                                    (95% CL)
                                  Effect Notes
                                     MRID;
                             Classifi-cation (Year)
 Freshwater invertebrates
 MCNI
 
 
 
 
 
 
 
 TGAI
 100%
 Water flea
 (Daphnia magna)
 48 h
 EC50: >50 mg a.i/L (95% CI N/A)
 Probit Slope: N/A
 
   * Daphnids exposed to negative control, solvent control and limit concentration of 50 mg a.i/L which represents the degradation product's limit of solubility.
   *  There were no mortality or sublethal effects observed in the controls or the single treatment concentration  
                                   48399936
                                   Acceptable
                                     (2008)
 S-2188-OH
 TGAI
 98.4%
 Water flea
 (Daphnia magna)
 48 h
 EC50 : >98 mg a.i/L (95% CI N/A)
 Probit slope: N/A
   * Daphnids were exposed to negative control and limit concentration of 98 mg a.i/L, mean measured
   *  There were no mortality or sublethal effects observed in the control or the single treatment concentration  
                                   48399937
                                  Acceptable
                                    (2008)
 S-2188-DC
 TGAI 100%
 Water flea
 (Daphnia magna)
 48 h
 EC50 : >94 mg a.i/L (95% CI N/A)
 Probit slope : N/A
   * Daphnids were exposed to negative control and limit concentration of 94 mg a.i/L, mean measured
   *  There was no mortality and surviving daphnids in the sole treatment concentration were observed to have abnormal swimming  
                                   48399938
                                  Acceptable 
                                    (2008)
 Freshwater Fish
 S-2188-DC
                                      TGAI
                                      100%
 Rainbow trout
 (Oncorhynchos mykiss)
                                      96 h
 LC50: > 89 mg a.i/L (95% CI N/A)
 Probit slope: N/A 
   * Fish were exposed to negative control and limit concentration of 89 mg a.i/L, mean measured
   *  There was no mortality or sublethal effects observed in the control or the single treatment concentration  
                              48399942 Acceptable
                                     (2008)
 S-2188-OH
                                      TGAI
                                     98.4%
 Rainbow trout
(Oncorhynchos mykiss)
                                      96 h
 LC50: > 97 mg a.i/L (95% CI N/A)
 Probit slope: N/A 
   *  Fish were exposed to negative control and limit concentration of 97 mg a.i/L, mean measured
   * There was no mortality or sublethal effects observed in the control or the single treatment concentration  

                                    48400043
                                   Acceptable
                                     (2008)
 Algal Toxicity
 S-2188-DC
 TGAI
100%
Freshwater Green algae 
 (Pseudokirchneriella subcapita)
                                      96 h
 EC50 (cell density): 32 mg a.i/L (30-35)
 
 NOAEC (cell density): 1.6 mg a.i/L
   * The percent growth inhibition I the treatment concentrations as compared to the negative control ranged from 1.1 to 89.3% based on cell density, 0.3 to 22.6% based on growth rate, and 1.1 to 57.6% based on biomass.  
 
                                    48400019
                                   Acceptable
                                     (2008)
 S-2188-OH
 98.4
Freshwater Green algae 
 (Pseudokirchneriella subcapita)
                                      96 h
 EC50 (cell density): 55 mg a.i/L) (46-65)
 
 NOAEC (cell density): 3.1 mg a.i/L
   * The percent growth inhibition in the treatment concentrations as compared to the negative control ranged from -2.3 to 72% based on cell density, -0.37 to 20% based on growth rate, and -1.2 to 66% based on biomass.
                                    48400020
                                   Acceptable
                                     (2008)

   *                         Freshwater Fish

Acute toxicity studies with technical-grade fenpyrazamine were available for 2 species of freshwater fish: rainbow trout and bluegill sunfish.  All studies were conducted on TGAI with 94.7% purity.  In the rainbow trout study (MRID 48399945), fenpyrazamine was administered in a flow-through exposure system and caused 100% mortality at the highest treatment concentration (7.8 mg a.i/L, mean measured).  All other treatment concentrations and control had mortality at or below 5%.  There were no sublethal effects noted in the lowest two treatment concentrations.  At the two higher treatment concentrations (2.1 and 3.8 mg a.i/L, mean measured), 7 and 20 fish exhibited lethargy in those treatment concentrations, respectively.  In the bluegill sunfish study (MRID 48399944), TGAI fenpyrazamine was administered in a flow through system.  The two highest treatment concentrations (6.9 and 12 mg a.i/L, mean measured) had 85 and 100 % mortality, respectively while the controls and other treatment concentrations had 0% morality during the study.  All fish in the highest treatment concentration exhibited a complete loss of equilibrium after three hours of exposure and were dead by six hours.  This study has an LC50 of 5.4 mg a.i/L and is classified as acceptable.  For risk assessment purposes, an acute toxicity value of 5.2 mg a.i/L (MRID 48399945) will be used for estimating acute risk quotients for freshwater fish.  

There were two additional acute freshwater fish toxicity studies submitted with degradation products of fenpyrazamine.  Both studies were conducted with the rainbow trout.  In one study conducted with 98.4% purity of degradation product S-2188-OH (MRID 48400043 ) at a single treatment concentration (97 mg a.i/L, mean measured), there were no mortalities or sublethal effects observed.  This study has an LC50 of 5.2 mg a.i/L and is classified as acceptable.  In another acute study conducted with 100% purity S-2188-DC (MRID 48399942), there were no mortalities or sublethal effects noted at the sole treatment concentration in the study, 89 mg a.i/L, mean measured.  This study has an L50 of >89 mg a.i/L and is classified as acceptable. 

An acceptable chronic early life stage test with a freshwater fish (rainbow trout, MRID 48400003) was conducted with TGAI fenpyrazamine (94.7% purity).  Fertilized egg/embryos were exposed at mean measured concentrations of 50, 100, 190, 370, and 750 ug a.i/L.  Embryo viability was determined on Day 19 and averaged 62 and 67% for the negative and solvent controls, respectively, and 70, 69, 70, 61, and 68% for the increasing treatment concentrations, respectively.  On day 30 of the study (Day 0, post-hatch) larval survival was significantly reduced (p<0.05) at the highest treatment concentration.  On day 90 of the study (Day 60, post-hatch) larval survival was also significantly reduced (p<0.05) only at the highest treatment concentration as compared to the negative control.  Mean total length, wet weight, and dry weight data were excluded for the highest treatment concentration due to effects on larval survival at that treatment concentration.  For those three endpoints, there were no significant reductions (p<0.05) as compared to the negative control.  The NOAEC and LOAEC for this study was determined to be 370 and 750 ug a.i/L, respectively based on effects to Day-0 post hatch larval survival and Day-60 post hatch larval survival.  For risk assessment purposes, a chronic toxicity of 370 ug a.i/L will be used for estimating chronic risk quotients for freshwater fish. 
 
   *                         Freshwater Invertebrates

An acute toxicity study conducted with TGAI fenpyrazamine (94.7%) on freshwater invertebrates was available for Daphnia magna.  A 48-h EC50 of 5.5 mg a.i/L was determined on the basis of immobilization.  Mortality/immobilization was 95% at the highest treatment concentration (8.0 mg a.i/L, mean measured), 5% at the second highest treatment concentration (3.8 mg a.i/L, mean measured) and 0% at the remaining treatment concentrations and controls.  There was a 55% portion of daphnids observed to be lethargic at test termination in the lowest treatment concentration (0.61 mg a.i/L, mean measured) while 100% of the surviving daphnids in the remaining treatment concentrations were observed to be lethargic.  This study is classified as acceptable.  For risk assessment purposes, an acute toxicity of 5.5 mg a.i/L will be used for estimating acute risk quotients for freshwater invertebrates. 

There were three additional acute freshwater invertebrate toxicity studies submitted with degradation products of fenpyrazamine.  All studies were conducted with the Daphnia magna.  In one study conducted with 98.4% purity of degradation product S-2188-OH (MRID 48399937) at a single treatment concentration (98 mg a.i/L, mean measured), there were no mortalities or sublethal effects observed and therefore this study had an EC50 value determined to be >98 mg a.i/L.  In another acute study conducted with 100% purity S-2188-DC (MRID 48399938), there were no mortalities or sublethal effects noted observed in the study and therefore the study had an EC50 determined to be >94 mg a.i/L.  Finally, a study with the degradation product MCNI (100% purity) (MRID 48399936) was submitted and conducted with a sole treatment concentration of 50 mg a.i/L which represents the limit of solubility for this degradate.  There were no mortalities or sublethal effects observed during the study and therefore the EC50 was determined to be >50 mg a.i/L.  All studies were classified as acceptable.

A freshwater invertebrate (Daphnia magna) lifecycle test with fenpyrazamine TGAI (94.7%) was submitted and found to be acceptable (MRID 48400001).  Daphnids were exposed throughout their life cycle to mean measured concentrations of fenpyrazamine ranging from 0.085 to 1.4 mg a.i/L for 21 days. Survival ranged from 90 to 100% for all levels, with no statistically-significant differences indicated at any treatment level compared to the negative control.  The cumulative number of offspring released per female after 21 days was significantly reduced (p<0.05) at the two highest treatment concentrations (0.76 and 1.4 mg a.i/L, mean measured) as compared to the negative control.  The number of immobilized offspring, if any, was not reported.  At study termination, mean total body lengths of surviving daphnia were significantly reduced (p<0.05) compared to the negative control at the two highest treatment concentrations.  Mean dry weights of surviving daphnia were only significantly reduced (p<0.05) at the highest treatment concentration.  It was reported that the first brood released occurred on Day 7 at the negative control, solvent control, and the three lowest treatment concentrations (0.085, 0.18, and 0.34 mg a.i/L, mean measured).  At the second highest treatment concentration, this time was Day 9 and at the highest treatment concentration this time was Day 10.  There were no conclusions drawn by the study author, but the data support a treatment-related delay at the two highest treatment concentrations for time to first brood. The most sensitive endpoints of the study were time to first brood release and total length of surviving daphnids with NOAEC and LOAEC values of 0.34 and 0.76, respectively.  For risk assessment purposes, a chronic toxicity value of 0.34 mg a.i/L will be used for estimating chronic risk quotients for freshwater invertebrates.
   *                         Estuarine/Marine Fish
 
 One acute toxicity study was submitted conducted with TGAI fenpyrazamine (98.8% purity) to the sheepshead minnow (MRID 48399946).  Mortality was observed at 20% in the highest test concentration (3.9 mg a.i/L, mean measured) but was 0% in all other treatment concentrations.  There were no sublethal effects observed in the negative control and all treatment concentrations except the highest.  At the 3.9 mg a.i/L level, there were several (number not defined in the study report) fish that were reported as being lethargic and two surviving fish that exhibited a partial loss of equilibrium.  The LC50 for this study was determined to be >3.9 mg a.i/L and this study is classified as acceptable.  For risk assessment purposes, an acute toxicity value of 3.9 mg a.i/L will be used for estimating acute risk quotients for estuarine/marine fish (i.e., a lower bound of 3.9 mg a.i/L will be assumed as a screen for acute effects).
 
An estuarine/marine chronic fish early life stage test conducted with fenpyrazamine TGAI (98.8%) on the sheepshead minnow was submitted and found to be supplemental (non-definitive NOAEC for most sensitive endpoint and clinical signs of toxicity not noted, MRID 48400004).  Embryos to their larval stage were exposed to fenpyrazamine levels ranging from 0.039 to 1.2 mg a.i/L for 33 days.  There were no treatment-related effects on hatching success (assessed on Day 5) or post-hatch survival) assessed on Day 33) observed with no significantly different (p<0.05) effects when compared to the negative control.  Mean percent hatching success ranged from 92 to 98% across all treatment concentrations (including the negative control) and mea larval survival ranged from 95 to 100%.  Total length measurements were significantly reduced from the negative control (p<0.05) at all treatment levels.  Dry weights were significantly reduced (p<0.05) at the two highest treatment concentrations (0.58 and 1.2 mg a.i/L, mean measured).  The most sensitive endpoint of the study was total length of surviving larval fish with NOAEC and LOAEC values of <0.039 and 0.039 mg a.i/L, respectively.  For risk assessment purposes, a chronic toxicity value of 0.039 mg a.i/L will be used for estimating chronic risk quotients for freshwater fish (i.e., an upper bound of 0.039 mg a.i/L will be assumed as a screen for chronic effects).
   *                         Estuarine/Marine Invertebrates
 
 Acceptable acute toxicity studies were available for two species of estuarine/marine invertebrates: the mysid shrimp (Americamysis bahia; MRID 48399941) and eastern oyster (Crassotrea virginica; MRID 48399940, both conducted with TGAI fenpyrazamine (98.8% purity). With mysids, a 96-h LC50 value of 0.83 mg a.i/L was determined from the study.  Total mortality occurred in the three highest treatment concentrations (1.2, 2.3, and 4.6 mg a.i/L, mean measured).  
 
 With the eastern oyster, a 96-h EC50 for shell deposition was determined to be 0.78 mg a.i/L.  Shell growth was reduced by 30.4, 21.7, 21.7, 30.4, and 73.9 % relative to the negative control at the 0.066, 0.12, 0.24, 0.49, and 1.0 mg a.i/L treatment concentrations, respectively (mean measured concentrations).  There was no mortality observed in the study.   For risk assessment purposes, an acute toxicity value of 0.78 mg a.i/L will be used to assess acute risks to estuarine/marine invertebrates.
 
An estuarine/marine invertebrate (Americamysis bahia) lifecycle test with fenpyrazamine TGAI (98.8 %) was submitted and found to be acceptable (MRID 48400002).  Mysids were exposed throughout their life cycle to mean measured concentrations of fenpyrazamine ranging from 3.2  -  98 ug a.i/L for 28 days.  Parental survival ranged from 83 - 100% for all levels, with no statistically-significant differences indicated at any treatment level compared to the negative control.  The cumulative number of offspring released per female after 28 days was also not significantly reduced (p<0.05) at any of the treatment concentrations.  Male and female mean dry weight, time to first brood release and male mean total length were also not significantly reduced from the negative control.  For female total body length, statistical hypothesis testing determined a significant effect (p<0.05) at the 3.2, 47, and 98 ug a.i/L treatment concentrations.  However these effects were 3.5, 5.3 and 2.5 % reductions from the negative control and because they did not follow a dose responsive pattern, it was determined that the NOAEC for this endpoint was the highest treatment concentration (98 ug a.i/L) for which there was a 2.5 % reduction from control.  Therefore the NOAEC and LOAEC for this study were 98 and >98 ug a.i/L, respectively.  For risk assessment purposes, a chronic toxicity value of 98 ug a.i/L will be used for estimating chronic risk quotients for estuarine/marine invertebrates (i.e., a lower bound of 98 ug a.i/L will be assumed as a screen for chronic effects).
   *                         Benthic (Sediment Dwelling) Invertebrates
 
 Effects of fenpyrazamine on freshwater benthic invertebrates are available from two studies: a 42d exposure via spiked sediment to the amphipod Hyalella azteca (MRID 48400006) and a 28d exposure via spiked overlying water to the midge Chironomus riparius (MRID 48400007).  In the Hyalella study, 8 day old amphipods were exposed to spiked sediment concentrations that were time weighted averaged to yield 5.7, 10, 24, 38, and 97 mg a.i/L.  On Day 28, survival was statistically significant (p<0.05) in the three highest treatment concentrations when compared to the negative control.  These treatment concentrations were excluded from the Day 28 dry weight analysis and there were no significant reductions from the negative control in the two lowest treatment concentrations.  On Day 35, survival was significantly reduced (p<0.05) at all but the lowest treatment concentration as compared to the negative control.  The number of offspring per female had significant (p<0.05) at all but the lowest treatment concentration when compared to the negative control.  On Day 42, survival was significantly reduced (p<0.05) when compared to the negative control at the three highest treatment concentrations.   These three concentrations were excluded from further statistical analysis for Day 42 dry weights, number of offspring per female, and male to female ratio endpoints.  For Day 42 dry weights, number of offspring per female, and male to female ratio, there were no significant (p<0.05) effects at the two lowest treatment concentrations when compared to the negative control.  On the basis of sediment dry weight and pore water, the NOAECs from this study are 5.7 mg/kg dw sediment and 0.5 mg a.i/L, respectively for the most sensitive endpoints which are Day 35 survival, Day 35 number of offspring per female and Day 42 survival.  This study is classified as acceptable.
 
Results from the chronic study on C. riparius indicate a much lower NOAEC for this species compared to the chronic study with amphipod (<101 ug a.i/kg sediment for midge vs. 5700 ug a.i./kg sediment for amphipod).  This lower NOAEC likely reflects a combination of factors including interspecies differences in sensitivity to fenpyrazamine and measurement of additional endpoints (e.g., development rate).  It is important to note, however, that this study involved exposure via the overlying water and concentrations varied considerably over time.  Specifically, both pore water and sediment concentrations increased dramatically from day 0 to day 28, while overlying water concentrations decreased, thus reflecting the expected partitioning of fenpyrazamine to sediments from the water column.  Freshwater midges were exposed to time weighted averaged sediment concentrations of 101, 215, 326, 611, and 790 ug a.i/kg dw sediment.  Percent emergence was significantly reduced (p<0.05) at the two highest treatment concentrations as compared to the negative control.  The combined male and female development rate was significantly reduced (p<0.05) at the two lowest and two highest treatment concentrations.  Although the test guideline followed in this study (OECD 219) is designed to mimic a spray drift event, a study that uses spiked sediment, simulating a runoff or erosion event is preferred.  OCSPP test guidelines recommend that sediments be equilibrated with test compound prior to testing.  This study is classified as supplemental for this reason as well as the fact that a definitive NOAEC was not achieved for the most sensitive endpoint of this study.  For risk assessment purposes, a toxicity value of 101 ug a.i/L will be used for estimating chronic risk quotients for freshwater benthic invertebrates in the sediment and 20 ug a.i/L for freshwater benthic invertebrates in the pore water (i.e., an upper bound of 101 ug a.i/kg dw sediment and 20 ug a.i/L will be assumed as a screen for chronic effects).
 
The effects of fenpyrazamine on the saltwater amphipod, Leptocheirus plumulosus, were examined in a 28-d spiked sediment exposure study (MRID 48400008).  Time weighted average concentrations of 3.0, 6.3, 12, 25, and 50 mg a.i/kg dw sediment in addition to solvent and negative controls. Survival was significantly reduced (p<0.05) at the two highest treatment concentrations as compared to the negative control.  The number of offspring per female was significantly reduced (p<0.05) at the 12 mg a.i.kg dw sediment treatment concentration when compared to the negative control.  For mean dry weight, there were significant reductions (p<0.05) at all three treatment concentrations that were not excluded from the analysis due to effects on survival.  The resultant NOAEC and LOAEC for this study was <3 and 3 mg a.i/kg dw sediment based on effects to dry weights.  The corresponding NOAEC and LOAEC for pore water concentrations is <0.25 and 0.25 mg a.i/L.  This study was classified as supplemental as it does not achieve a definitive NOAEC for the most sensitive endpoint of the study.    For risk assessment purposes, a toxicity value of 3 mg a.i/kg dw sediment will be used for estimating chronic risk quotients for estuarine/marine benthic invertebrates in the sediment and 0.25 mg a.i/L for estuarine/marine benthic invertebrates in the pore water (i.e., an upper bound of 3 mg a.i/kg dw sediment and 0.25 mg a.i/L will be assumed as a screen for chronic effects).
   *                         Vascular and Non-vascular Aquatic Plants
 
One vascular aquatic plant study (MRID 48400018) was submitted along with three non-vascular aquatic plant studies (algae) were submitted conducted with TGAI fenpyrazamine (MRIDs 48400021, 48400022, 48400023, and 48400024).

In the aquatic vascular plant toxicity study, Lemna gibba (duckweed) was exposed to mean measured treatment concentrations ranging from 0.023 to 5.9 mg a.i/L.  The percent growth inhibition in the treated culture as compared to the negative control ranged from -11 to 79% based on frond density, 1 to 90% based on frond weight, and 5 to 55% based on days 0 to 7 growth rate.  Fronds in the two highest treatment groups were smaller and had reduced root development relative to the negative control.  There were no other morphological abnormalities noted in the negative control or any other treatment concentrations.  The most sensitive endpoint for this study was frond weight with a 96-h EC50 and NOAEC value of 1.1 and 0.060 mg a.i/L, respectively.  This study is classified as acceptable.  For risk assessment purposes, a toxicity value of 1.1 mg a.i/L will be used to assess risk to non-listed aquatic vascular plants while a value of 0.060 mg a.i/L will be used to assess risk to listed aquatic vascular plants.    

Four acceptable studies with aquatic non-vascular plants (algae) were submitted with TGAI fenpyrazamine (94.7  -  98.8% % purity).  In one study conducted with freshwater green algae (Pseudokirchneriella subcapitata, MRID 48400021), fenpyrazamine was exposed to cultures ranging from 0.053 to 0.90 mg a.i/L, mean measured concentrations.  The percent growth inhibition in the treated algal culture as compared to the negative control ranged from 26 to 95% based on cell density, 5 to 48% based on growth rate, and 15 to 92% based on biomass.  At test termination, cells at the highest treatment concentration were observed to be bloated while cells in the negative control and remaining treatment concentrations appeared normal.  The most sensitive endpoint was cell density with 96-h EC50 and NOAEC values of 0.16 and <0.053 mg a.i/L, respectively.  As the NOAEC for this endpoint was non-definitive, EFED policy is use the EC05 in place of the NOAEC for this endpoint, which was determined to be 0.029 mg a.i/L.

In an acceptable study with the marine diatom Skeletonema costatum (MRID 48400022), TGAI fenpyrazamine was exposed in mean measured concentrations of 0.0045, 0.011, 0.028, 0.18, 0.42, and 1.2 mg a.i/L to cultures.  The percent growth inhibition in the treated algal culture as compared to the negative control ranged form 3 to 97% based on cell density, the most sensitive endpoint.  Cells in the negative control group and all treatment concentrations appeared normal throughout the duration of the test.  The 96-h EC50 and NOAEC values for this test (based on cell density) are 0.027 and <0.0045 mg a.i/L.  As the NOAEC for this endpoint was non-definitive, EFED policy is use the EC05 in place of the NOAEC for this endpoint, which was determined to be 0.002 mg a.i/L.  

In an acceptable study with the freshwater diatom Navicula pelliculosa, (MRID 48400023), TGAI fenpyrazamine was exposed in mean measured concentrations of 0.0049, 0.012, 0.030, 0.074, 0.019, and 0.47 mg a.i/L to cultures.  The percent growth in the treated algal culture as compared to the negative control ranged from -11 to 99% based on cell density, the most sensitive endpoint.  Cells in the negative control group and all treatment concentrations appeared normal throughout the duration of the test.  The 96-h EC50 and NOAEC values form this test (based on cell density) are 0.011 and 0.0049 mg a.i/L, respectively.  

A study conducted with TGAI fenpyrazamine on the cyanobacteria Anabaena flos-aquae (MRID 48400024) exposed cultures to mean measured concentrations of 0.045, 0.12, 0.28, 0.74, 1.8, and 4.6 mg a.i/L.  The percent growth inhibition in the treated algal culture as compared to the negative control ranged from 12 to 87% based on cell density, the most sensitive endpoint.  Cells in the negative control and treatment concentrations appeared normal throughout the duration of the study.  The 96-h EC50 and NOAEC values (based on cell density) were 1.2 and 0.74 mg a.i/L. This study is classified as acceptable. For risk assessment purposes, a toxicity value of 0.011 mg a.i/L will be used to assess risk to non-listed aquatic non-vascular plants while a value of 0.0049 mg a.i/L will be used to assess risk to listed aquatic non-vascular plants.    

Additionally, two acceptable aquatic non-vascular plant toxicity studies were submitted with degradation products of fenpyrazamine.  Both studies were acceptable and exposed degradation products to the freshwater green algae Pseudokirchneriella subcapitata.  In one study with S-2188-DC (100% purity) green algae cultures were exposed to mean measured concentration is 1.6, 3.0, 6.0, 13, 24, 47, and 98 mg a.i/L.  The percent growth inhibition in the treated algal culture as compared to the negative control ranged from 1.1 to 89.3 % based on cell density, 0.3 to 22.6% based on growth rate, and 1.1 to 57.6% based on biomass.  Aggregation was observed in the three highest treatment concentrations.  There were no morphological abnormalities observed in any treatment concentration throughout the 96-hour exposure period.  The EC50 and NOAEC values (based on cell density) are 32 and 1.6 mg a.i/L, respectively.

In another study conducted with Pseudokirchneriella subcapitata, the fenpyrazamine degradate S-2188-OH (98.4% purity) was exposed to cultures at mean measured concentrations of 1.6, 3.1, 6.3, 13, 25, 48, and 99 mg a.i/L.  The percent growth inhibition in the treated algal culture compared to the negative control ranged from -2.3 to 72% based on cell density, -0.37 to 20% based on growth rate, and -1.2 to 66% based on biomass.  Aggregation was observed in the three highest treatment concentrations.  There were no morphological abnormalities observed in any treatment concentrations throughout the 96 hour exposure period.  The EC50 and NOAEC values based on cell density were 55 and 3.1 mg a.i/L, respectively.  
 
                     4.4.1 Terrestrial Effects
                   
All toxicity reference values used to assess the potential acute and chronic risks of fenpyrazamine exposure to birds and mammals were obtained from acceptable or supplemental studies using fenpyrazamine TGAI (Table 9). 

Table 9.  Toxicity Reference Values For Terrestrial Organisms Exposed To Fenpyrazamine.
                               Exposure Scenario
                                     % A.I.
                                    Species 
                                      Dur.
                           Toxicity Reference Value 
                                    (95% CL)
                                  Effect Notes
                                     MRID;
                                Classifi-cation 
 Avian Toxicity
                                     Acute
                                  TGAI   98.8%
 Canary  Serinus canaria 
 (Acute Oral)
                                      14 d
 LD50 >2000 mg a.i/kg bw (95% CI not available)
 
   * No mortalities in control or at the 2000 mg a.i/kg bw treatment concentration  
   * No clinical signs of toxicity or sublethal effects were observed
                              48400010 Acceptable
                                     (2010)
                                                                               
                                  TGAI   97.7%
 Mallard Duck Anas platyrhynchos
 (Subacute, Dietary)
                                      8 d
 LC50 >4430 mg a.i/kg diet (95% CI not available)
   * Five mortalities were observed during the study, three in the 2360, and two in the 4430 mg a.i/kg diet treatment concentrations, mean measured
   * Group body weight gain was significantly reduced (p<0.05) at the 4430 mg a.i/kg diet 
                              48400012 Acceptable
                                     (2006)
                                                                               
                                  TGAI   94.7%
 Bobwhite Quail Colinus virginianus
 (Acute Oral)
                                      14 d
 LD50 >2000 mg a.i/kg bw
 Probit slope: N/A
   * No mortalities in control or at the 5000 mg/kg test level. 
   *  No clinical signs of toxicity or sublethal effects observed at all treatment concentrations  
                             48400009   Acceptable
                                     (2006)
                                                                               
                                  TGAI   94.7%
 Bobwhite Quail Colinus virginianus
 (Subacute Dietary)
                                      8 d
 LC50: >5039 mg a.i/kg diet (95% CI not available)
 
   * The only mortality in the study occurred in the highest treatment concentration (5039 mg a.i/kg diet, mean measured)
   * Group body weight gain was significantly reduced (p<0.05) at the two highest treatment levels (2687 and 5039 mg a.i/kg diet)
   * Clinical sings of toxicity included wing droop and lethargy which were observed in two birds in the highest treatment concentration, one of which later died, representing the single mortality in the study 
                                    48400011
                                   Acceptable
                                     (2006)
                                                                        Chronic
                                  TGAI   94.7%
 Mallard Duck Anas platyrhynchos
                                     22 wk
 NOAEC=517 mg a.i/kg diet 
 LOAEC=1022 mg a.i/kg diet
 
   * One adult mortality was observed during the test
   * No clinical sings of toxicity, effects on food consumption, or effects on reproductive parameters were observed at any treatment concentration during the test
   * 14-day survivor body weight in the 1022.3 mg a.i/kg diet treatment concentration (the highest tested) was significantly reduced (p<0.05) from the control) 
                                    48400013
                                   Acceptable
                                     (2008)
 
                                  TGAI   94.7%
 Bobwhite Quail Colinus virginianus
                                     24 wk
 NOAEC= 248 mg a.i/kg diet 
 LOAEC=495 mg a.i/kg diet
 
   * Three adult mortalities although post mortem analysis showed they may not have been chemical related
   * There were significant (p<0.05) reductions in adult female body weight gain at the 495 mg a.i/kg diet test concentration
                              48400014 Acceptable
                                     (2008)
 Mammals
                                     Acute
 TGAI
 94.8%
 Rat
 (Rattus norvegicus)
 
 
 14 d
 LD50 >2000 mg ai/kg bw (females)
 
   * No mortality occurred in the study
   * No abnormal clinical sings of toxicity were evident
   * One anima had fluid retention in the uterus at post mortem not considered to be treatment related
 
                                    48400106
                                   Acceptable
                                     (2007)
 Chronic
 TGAI
 94.7%
 Rat
 (Rattus norvegicus)
 
 2 gen
 NOAEL = 1000 ppm
 LOAEL = 3000 ppm
   * There were no treated related mortalities or clinical signs of toxicity in any generation
   * In the parental generation and F1 generation, there were no significant (p<0.05) differences in body weight gain
   * There was a statistically significant decrease (p<0.05) in food consumption of parental females during pre-mating and gestation of the highest treatment level
   * There were no effects on oestrus cycle, number of pairs mating, time to mating, number of females becoming pregnant, or the length of gestation in the P and F1 generation parents
   * Mean pup weight of F1 pups at birth and 21 days post partum was significantly lower (p<0.05) in the highest treatment level
   * There was a significant reduction (p<0.05) in the mean number of implantations per dam and litter size, and a statistically significant increase in post implantation loss.
 
 48400127
 Acceptable
 (2009)
 Nontarget Insects - Bees
                                     Acute
                                  TGAI   94.7%
 Honeybee  Apis mellifera
 (Acute contact toxicity)
                                      48 h
 LD50: > 100 ug ai/bee (95% CI N/A)
 Probit slope: N/A
   * Mortality was 0, 3.3, 13.3, 6.7, 13.3, and 26.6% at the 1.9, 4.3, 9.4, 21, 45, and 100 ug a.i/bee treatment concentrations
   * Mortality in the negative and solvent controls was 10% and 3.3%, respectively. 

                                    48400015
                                   Acceptable
                                     (2006)
                                                                               
                                  TGAI   97.6%
 Honeybee        Apis mellifera
 (Oral toxicity study)
                                      48 h
 LD50: > 100 ug ai/bee (95% CI N/A)
 Probit slope: N/A 
   * Mortality was 10, 6.7, 3.3, 23, 20% at the 6.3, 13, 25, 50, and 100 ug a.i/bee 
   * Mortality in negative and solvent controls was 0%.
                                    48399935
                                  Supplemental
                                     (2006)
 Other Non-target Terrestrial Organisms
                                     Acute
                                   TGAI 94.7%
                           Earthworm (Eisenia fetida)
                                      14 d
 LC50: >800 mg a.i/kg dw soil
 NOAEC (body weight): 25 mg a.i/kg soil
 
   * Mortality was 0, 0, 0, 0, 0, 2.5, 7.5, and 2.5 % at the negative control, solvent control, and the 25, 50, 100, 200, 400, and 800 mg a.i/kg soil concentrations 
   * Body weight was significantly reduced (p<0.05) at all but lowest concentration
 
                                   48400025 
                                  Supplemental
                                     (2006)
 Terrestrial Plant
                               Seedling emergence
                                        
                                      TEP 
                                     44.4%
                                        
                                Multiple species
                                        
                                      21 d
 Most sensitive monocot: corn
 EC25 (survival): >1.54 lbs a.i/A (95% CI:  N/A)
 Slope : 2.97
 
 NOAEC: 0.15 lbs a.i/A
 -----------------------
 Most sensitive dicot, flax
 EC25 (weight): >0.53 lbs a.i/A (95% CI: N/A)
 Slope: 5.31
 
 NOAEC: <0.035 lbs a.i/A
 
   * The percent inhibition to seedling emergence in the treated species compared to negative control ranged from -20  -  27.6%
   * Phytotoxic effects included necrosis, leaf curl, stem curl, and unshed seed coat.
   * Corn was most sensitive monocot based on effects to survival
   * Flax was most sensitive dicot based on effects to biomass (weight)
  
                                    48400016
                                  Supplemental
                                     (2010)
                                Vegetative vigor
                                        
                                      TEP 
                                     44.4%
                                        
                                Multiple species
                                        
                                      21 d
 Most sensitive monocot
 EC25: Could not be determined due to lack of toxicity
 NOAEC: 0.56 lbs a.i/A
 -----------------------
 Most sensitive dicot
 EC25: Could not be determined due to lack of toxicity
 NOAEC: 0.56 lbs a.i/A
                                        
   * The % survival in all species was not significantly affected and the % inhibition of survival ranged from  to 4.2%. 
   * Phytotoxic effects included necrosis, leaf curl, stem curl, and unshed seed coat.
   * Length (height) and weight endpoints were not significantly affected at any treatment concentration for any species.
 
                                    48400017
                                  Supplemental
                                     (2010)
Bolded values refer to the most sensitive endpoint for a given taxa to be used in quantitative risk assessment.
                         
                         
                        *                         Birds (Acute Toxicity)

Acute oral and subacute dietary toxicity studies are available for three avian species (northern bobwhite quail, mallard duck, and canary) in three orders (Galliformes, Anseriformes, Passeriformes).  Overall, these studies indicate that fenpyrazamine is practically non-toxic to these species of birds on an acute exposure basis.  The acute oral LD50 values are > 2000 mg a.i/kg bw for both the northern bobwhite quail and canary studies (MRIDs 48400009 and 48400010, respectively) since no treatment-related mortality occurred at the highest dose tested.  Furthermore, there were no treatment-related sublethal signs of toxicity (body weight, food consumption) were reported in these studies.  In the canary study within the first hour of dosing, 3 birds regurgitated at the limit dose.  However, these birds were immediately replaced and none of the remaining birds regurgitated or showed other sublethal signs of toxicity.  Therefore, the study validity is not considered to be impacted by this low rate of regurgitation.  All three acute oral studies are classified as acceptable.   For risk assessment purposes, an acute oral LD50 of > 2000 mg a.i/kg bw) for passerines will be used qualitatively to evaluate potential acute effects to birds (i.e., a lower bound of 2000 mg a.i/kg bw will be assumed as a screen for acute effects).

There were two subacute studies submitted for the northern bobwhite quail and mallard duck (MRIDs 48400011 and 48400012, respectively).  In the northern bobwhite quail study, TGAI fenpyrazamine was exposed in the diet at mean measured concentrations of 306.9, 628.1, 1318, 2687, and 5039 mg a.i/kg diet.  There was a single mortality that occurred at the highest treatment concentration.  The bird displayed wing droop and lethargy prior to death.  There were no other clinical signs of toxicity that were observed during the test.  Mean body weight gain in the three highest treatment concentrations was significantly lower (p<0.05) as compared to the negative control.  There were no treatment related effects on food consumption noted.  The resultant LC50 for the study was >5039 mg a.i/kg-diet and this study was classified as acceptable.  

For the mallard duck study, TGAI fenpyrazamine was administered in the diet at 291 568, 1210, 2360, and 4430 mg a.i/kg-diet (mean measured concentrations).  There were a total of five mortalities that occurred during the study, three birds at the 2360 and two birds at the 4430 mg a.i/kg-diet treatment concentrations.  There were no clinical signs of toxicity noted during the study.  The mean body weight gain was significantly lower (p<0.05) at the highest treatment concentration compared to the negative control.  There were no treatment related effects on food consumption noted during the study.  The resultant LC50 for this study was >4430 mg a.i/kg-diet and this study is classified as acceptable.  For risk assessment purposes, a subacute dietary  LC50 of > 4430 ppm in the diet) will be used qualitatively to evaluate potential acute effects to birds (i.e., a lower bound of 4430 ppm will be assumed as a screen for acute effects).

                        *                         Birds (Chronic Toxicity)

Two studies were submitted that examined the chronic toxicity of fenpyrazamine to avian species.  In the study with mallard duck (MRID 48400013) fed 26 week old mallards (4 groups of 16 replicate pairs/group including control) approaching their first breeding season a diet containing 258, 517 or 1000 mg a.i/kg-diet of TGAI fenpyrazamine (94.7%i). There was a single adult mortality observed during the test from the control group that was found dead approximately 19 weeks post treatment.  There were no overt clinical signs of toxicity observed at any of the treatment concentrations nor were there any treatment related effects on adult body weight or food consumption.  Mean 14-day survivor body weight was significantly reduced (p<0.05) in the highest treatment concentration as compared to the negative control.  The study author did not consider this to be a treatment related effect, citing one reason as a failure to detect a similar effect in the companion northern bobwhite quail study (MRID 48400014).  The study reviewer however did find evidence of a treatment related effect for this endpoint and therefore could not dismiss the effects observed in this study.  Aside from this effect on 14-day survivor body weight, there were no other statistically significant treatment related effects on any reproductive parameters at any treatment concentration.  The resultant NOAEC and LOAEC for this study were 519 and 1022 mg a.i/kg-diet, respectively based on 14-day survivor body weight and the study is classified as acceptable. 

In the study with the northern bobwhite quail (MRID 48400014) fed 28 week old quail (4 groups of 18 replicate pairs/group including control) approaching their first breeding season a diet containing mean measured concentrations of  248, 495, and 978 mg a.i/kg-diet of TGAI fenpyrazamine (94.7%). There were three adult mortalities that occurred during the study, none of which were considered treatment related.  There were no overt clinical signs of toxicity observed at any of the treatment concentrations.  There were no significant reductions in hatchling body weight, however there was a slight significant reduction (p<0.05) of 14-day survivors at the 495 mg a.i/kg-diet treatment concentration.  There were no other statically significant effects on any other reproductive parameter at any treatment concentration.  The resultant NOAEC and LOAEC for this study was 248 and 495 mg a.i/kg-diet, respectively, based on 14-day survivor body weight and the study is classified as acceptable.  The dietary chronic NOAEL of 248 ppm will be used in estimating chronic risk quotients to avian species. 
 
                        *                         Mammals (acute toxicity)
 
For evaluating acute oral toxicity for mammals, an acute study with the rat (MRID 48400106) was conducted with TGAI fenpyrazamine (94.8%) at a single treatment concentration.  There were no mortalities observed during the study along with no treatment related effects on body weight or clinical signs of toxicity.  The LD50 was therefore determined to be >2000 mg a.i/kg-bw which categorizes fenpyrazamine as practically non-toxic to mammals on an acute oral basis.  This study is classified as acceptable.  An acute oral LD50 value of 2000 will be used as a lower bound for estimating acute RQs for mammals.

                        *                         Mammals (chronic toxicity)
  
There was an acceptable chronic two-generation reproduction study conducted with the Norway rat submitted in support of fenpyrazamine (MRID 48400127).   TGAI (94.7%) fenpyrazamine was administered continuously in the feed to rats at dietary concentrations of 0, 400, 1000, and 3000 ppm. The toxicological response of the treated animals was principally characterized by increase in relative liver and thyroid weight and histological findings in these organs (cell hypertrophy) and reduced food consumption and decreased body weight gain throughout the whole study period. Significantly lower number of implantations, significantly increased post implantation loss and significantly increased post natal loss in the high dose group of F1 generation is considered to be the effect of systemic toxicity in maternal animals (body weight gain loss, body weight reduction, thyroid enlargement, hepatocellular and thyroid cell hypertrophy). Fenpyrazamine showed no effects on fertility.  A NOAEL for reproductive effects was determined at the treatment level of 1000 ppm (73.7 mg/kg bw/d; mean substance intake of females of F1 generation during gestation), based on significantly decreased number of implantations observed in F1 females at 3000 ppm (which was determined to be the LOAEL of the study.  A chronic NOAEL value of 1000 will be used to estimate chronic RQs for mammals.

                        *        Non-target Beneficial Insects

Two studies were submitted that examined the acute toxicity of fenpyrazamine to the honeybee (Apis mellifera).  The first study, examined acute oral exposure of bees to fenpyrazamine (94.7% a.i) for 48 hours (MRID 48399935).  The bees were exposed to nominal doses of 6.3, 13, 25, 50, and 100 ug a.i/bee, as well as negative and solvent controls.     A maximum of 23.3 % mortality occurred at the second to highest treatment dose (50 ug a.i/bee) thus yielding an LD50 of >100 ug a.i/bee.  At test termination, a single bee in the 25 ug a.i/bee treatment concentration was observed to be lethargic.  There were no other clinical signs of toxicity at any treatment concentration during the study.  This study is classified as supplemental as it does not fulfill any current OCSPP guideline requirement.

In another study (MRID 48400015), bees were exposed to TGAI fenpyrazamine (94.7%) in an acute contact design that included nominal concentrations of 1.9, 4.3, 9.4, 21, 45, and 100 ug a.i/bee.  After 48 hours, there was a maximum 26.6% mortality that was observed in the highest treatment concentration.  Clinical signs of toxicity included bees that appeared to be lethargic which varied in number depending on the treatment concentration but did follow a dose responsive pattern.  The LD50 for this study was determined to be >100 ug a.i/bee and the study is classified as acceptable.

                        *        Other Non-target Terrestrial Organisms

An acute toxicity study was submitted that exposed TGAI fenpyrazamine to the earthworm (Eisenia fetida, MRID 48400025).  Earthworms were exposed to nominal concentrations of 25, 50, 100, 200, 400, and 800 mg a.i/kg dw soil in addition to negative and solvent controls.  After a 14-day exposure, survival ranged from 92.5 to 100%, depending on the treatment concentration.  Body weight was significantly reduced in all but the lowest treatment concentration as compared to the negative control.  Lethargy was observed in earthworms exposed to 100 and 800 mg a.i/kg dw soil and segmental constriction was observed in earthworms in the 800 mg a.i/kg dw soil treatment concentration.  The LC50 was determined to be >800 mg a.i/kg dw soil.  This study was scientifically sound but is not designed to fulfill any current OCSPP guideline requirement and is therefore classified as supplemental.



                        *        Terrestrial Plants

A seedling emergence and vegetative vigor study were submitted with TEP fenpyrazamine (44.4% a.i) (MRIDs 48400016 and 48400017, respectively).  In the seedling emergence study, seeds were exposed to mean measured concentrations ranging from 0.035 to 0.062 lb a.i./A depending on the species for 21 days.  Survival in corn and biomass (weight) in radish and flax were significantly affected (p<0.05).  The most sensitive monocot species was corn based on effects to survival while the most sensitive dicot was flax, based on effects to biomass.  In both species, the percent inhibition to survival and weight did not exceed? 25% and therefore EC25 values were not definitive.  By contrast, there were effects on biomass (weight) to flax in the lowest treatment concentration and therefore a definitive NOAEC could not be determined for this species.  The percent reduction from control in the lowest treatment concentration for flax weight was 38.5 while the other percent reductions for this endpoint were 7.9, 11.5, 27.5, and 30.2 for the lowest to highest treatment concentrations.  Although the effects do not follow a dose responsive pattern, some chemicals are known to show increased effects at lower concentrations.  Currently, there is not enough information about fenpyrazamine to definitively state whether it is among those chemicals yet a 38.5 % effect at the lowest treatment concentration is enough of a biological effect to warrant a concern.  Phytotoxic effects in this study included necrosis, stem curl, and unshed curl.  Phytotoxicity signs were infrequent and did not appear to be the result of treatment, with the exception of flax and radish which had higher and more consistent phytoxicity signs.  The most sensitive monocot NOAEC, LOAEC and EC25 was 0.15, 0.30, and >0.60 lbs a.i/A based on survival.  The most sensitive dicot NOAEC, LOAEC, and EC25 was <0.035, 0.035, and >0.53 lb a.i/A based on biomass (weight).  In the event that a NOAEC is not definitive, EFED policy is to use the EC05 in its place for estimation of RQs.  However, despite the model converging, an EC05 was unable be estimated for this endpoint.  This study is classified as supplemental for this reason as well as since the temperature in the test facility ranged from 18 to 38°C (64.4  -  100.4°F) and the relative humidity ranged from 14  -  93% during the test.  OCSPP guidelines recommend day temperatures of 25 +- 3°C (71.6  -  82.4°F) and night temperatures of 20 +- 3 °C (62.6  -  73.4°F) and relative humidity approaching 70 +- 5 % during light period and 90 % during dark periods.  The ranges of temperatures and relative humidity for this study are well outside the recommended ranges and bring into question either the test facility conditions or the gauges associated with temperature and relative humidity equipment.  

In a vegetative vigor study conducted with TEP fenpyrazamine (MRID 48400017), plants were exposed to mean measured concentrations of fenpyrazamine ranging from 0.034 to 0.56 lbs a.i/A depending on the test species for 21 days.  Survival in all species was not significantly affected as the percent inhibition as compared to the negative control ranged from 0 to 4.2%.  Phytotoxic effects in this study included necrosis, leaf curl, stem curl, and unshed seed coat.  Overall, the seedlings appeared normal throughout the course of the study.  Phytotoxic signs were infrequent and did not appear to be the result of treatment.  There were no significant effects to dry weight and height.  The NOAEC, LOAEC and EC25  - values for the most sensitive dicot species was 0.53, >0.53, and >0.53 based on a lack of effects at all treatment concentrations.  This study is classified as supplemental since the temperature in the test facility ranged from 17 to 32°C (62.6  -  89.6°F) and the relative humidity ranged from 32  -  95% during the test.  OCSPP guidelines recommend day temperatures of 25 +- 3°C (71.6  -  82.4°F) and night temperatures of 20 +- 3 °C (62.6  -  73.4°F) and relative humidity approaching 70 +- 5 % during light period and 90 % during dark periods.  The ranges of temperatures and relative humidity for this study are well outside the recommended ranges and bring into question either the test facility conditions or the gauges associated with temperature and relative humidity equipment.  For risk assessment purposes, a toxicity value of >0.53 lbs a.i/A will be used for estimating risk quotients to non-listed terrestrial plants (i.e., a lower bound of 0.53 lbs a.i/A will be used as a screen for toxic effects and a toxicity value of <0.035 lbs a.i/A will be used for estimating risk quotients for listed terrestrial plants (i.e., an upper bound of 0.035 lbs a.i/A will be assumed as a screen for toxic effects).

                     5. PROBLEM FORMULATION
 
 Fenpyrazamine is formulated as a suspension concentrate for foliar ground and aerial spray and for spray chemigation.  The rate of application for fenpyrazamine ranges from an application rate of 0.375 lbs a.i/A to 1.089 lbs a.i/A with maximum number of applications being 3 or 4 depending on the use, and an interval between application of 7 days for all uses.  Fenpyrazamine, a fungicide, belongs to the pyrazole carboxamide class of fungicides.  Other members of this family of pesticides include penthiopyrad, penflufen, and sedaxane.  Fenpyrazamine's mode of action has not been fully elucidated, but it is thought to inhibit the generation of reproductive spores via inhibition of the germ tube and mycelium elongation.  In addition, pyrazole fungicides are known to inhibit the succinate-dehydrogenase enzyme which serves a critical mechanism as part of the citric acid cycle and providing a pathway for electronic transfer throughout the organism.
 
               5.1 Risk Hypotheses 

Risk hypotheses are specific assumptions about potential adverse effects (i.e., changes in assessment endpoints) and may be based on theory and logic, empirical data, mathematical models, or probability models (EPA 1998).  For fenpyrazamine, the following ecological risk hypothesis is being employed for this risk assessment:
      
      Given the proposed ground and aerial foliar spray uses of fenpyrazamine and its environmental fate properties, there is a likelihood of exposure to non-target terrestrial and aquatic organisms. 
            
      When used in accordance with the label, fenpyrazamine results in potential adverse effects upon the survival, growth, and reproduction of non-target terrestrial and aquatic organisms.  
      
               5.2 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 feasible route of exposure.
 
Fenpyrazamine is considered to be the primary stressor in this risk assessment.  Measured comprehensive toxicity data for freshwater fish, freshwater invertebrates, and aquatic plants indicate that fenpyrazamine is more toxic than the degradates S-2188-OH and S-2188-DC at magnitudes surpassing an order of magnitude.  Furthermore, ECOSAR indicates that fenpyrazamine is overall more toxic than the degradates S-2188-OH, S-2188-DC, MCNI, and the S-2188-DC conjugate.  The only exception is that the S-2188-DC conjugate is estimated to be more toxic than parent fenpyrazamine for green algae.  However, no exposure of green algae to the S-2188-DC conjugate is expected since the S-2188-DC conjugate is only found to bioconcentrate in fish tissue.  A summary of the measured and estimated endpoints comparing fenpyrazamine and the degradates can be found in Appendix G.

The environmental fate properties of fenpyrazamine indicate that dietary exposure to terrestrial organisms, exposure to terrestrial plants, and aquatic exposure are relevant paths of exposure associated with pesticide applications.  Direct deposition of fenpyrazamine sprays, runoff, leaching, and spray drift deposition represent potential transport mechanisms to aquatic and terrestrial organisms.  The movement away from the site of application in turn represents exposure pathways for a broad range of biological receptors of concern (non-target animals) and the potential attribute changes, i.e., effects such as reduced survival, growth and reproduction, in the receptors due to fenpyrazamine exposure.  Terrestrial animals may be exposed to fenpyrazamine by intentionally or inadvertently ingesting residues on treated crops.  They also may be exposed by other routes, such as by walking on residues or drinking water contaminated by residues.  Based on the nature of fenpyrazamine applications, as well as fenpyrazamine's moderate persistence and mobility in the environment, dietary exposure to terrestrial exposure and aquatic exposure from fenpyrazamine applications will be assessed.  Furthermore, given fenpyrazamine's tendency to bind to soil and sediment (as evidenced by the spiked water sediment toxicity study conducted with Chironomus riparius, MRID 48400007) , risks to bottom-dwelling organisms residing in the benthos as well as organisms which feed on sediment will be assessed.

Bioaccumulation of fenpyrazamine residues is not expected to be significant in fish.  As stated in Section 3, despite fenpyrazamine's high Kow value and expected bioconcentration, steady-state BCF values in fish are low (MRID No. 48400005).  In addition, fenpyrazamine is transformed rapidly to S-2188-DC and S-2188-DC conjugate in fish tissue.  Depuration of the metabolites detected in fish tissues is also rapid.


Drinking water and inhalation exposure to terrestrial animals are not expected to be of concern according to the results of the Screening Imbibition Program (SIP version 1.0, 6/15/2010) and the Screening Tool for Inhalation Risk (STIR version 1.0; 11/23/2010), respectively.  SIP is available publically at:  http://www.epa.gov/oppefed1/models/terrestrial/sip/sip_user_guide.html.  STIR may be accessed on-line at: http://www.epa.gov/oppefed1/models/terrestrial/stir/stir_user_guide.html.  The output files for STIR and SIP can be found in Appendices B and C, respectively.  

               5.1 Analysis Plan 

 The primary method used to assess risk in this screening-level assessment is the risk quotient (RQ) and follows the methods outlined in the EPA Overview Document (EPA, 2004).  The RQ is the primary risk value for the screening-level assessment and is the result of comparing measures of exposure to measures of effect. A commonly used measure of exposure is the estimated exposure concentration (EEC) and commonly used measures of effect include toxicity values such as the LD50 or NOAEC.  The RQ is calculated as a ratio of the estimated environmental concentration (EEC) to an effect level (e.g., LC50, LD50 or NOAEC) using the effect level as a denominator.  The resulting RQ is then compared to a specified level of concern (LOC), which represents a point of departure for concern.  For example, if the RQ exceeds the LOC, then there is the potential for risk.  In general, the higher the RQ, the more certain the potential risks. However, the risk quotients are not necessarily a true estimate of risk since there is no estimated probability of effect.  Risk presumptions, along with the corresponding RQs and LOCs, are summarized in Appendix A.
 
 Generation of robust risk quotients is dependent on the quality of data from both fate and toxicological studies.  The adequacy of the submitted data is evaluated relative to Agency guidelines.  For fenpyrazamine, the available ecological effects data is determined to be sufficient in evaluating the ecological risk to terrestrial and aquatic organisms as a result of the proposed uses.
 
                     5.3.1 Measures of Exposure 
 
 Measures of exposure are estimates of exposure for a receptor determined by modeling or monitoring data.  Measures of exposure for fenpyrazamine in this assessment are obtained from modeling efforts only, since this is a new chemical and national-scale monitoring data is not available.  Exposure models used for this assessment include the suite of standard exposure models commonly used in pesticide risk assessments (EPA, 2004).  Generally, aquatic exposure estimates are generated from EFED models. 
 
 To estimate risks of fenpyrazamine exposures in aquatic and terrestrial environments, all exposure modeling and resulting risk conclusions will be based on maximum application rates and methods cited in Table 1and will be estimated for each use of fenpyrazamine.  Measures of exposure are based on aquatic and terrestrial models that predict estimated environmental concentrations (EEC) of halofenozide.  The models used to predict surface water, benthic, and sediment aquatic EECs are the Pesticide Root Zone Model coupled with the Exposure Analysis Modeling System (PRZM/EXAMS) publically available at:  http://www.epa.gov/oppefed1/models/water/pe5_user_manual.htm.  The PRZM/EXAMS standard farm pond  scenario will be used to estimate the aquatic EECs.  The model used to predict terrestrial EECs on food items is the Terrestrial Residue Exposure (T-REX) publically available at:  http://www.epa.gov/oppefed1/models/terrestrial/trex/t_rex_user_guide.htm.   The model used to derive EECs relevant to terrestrial and wetland plants is TerrPlant accessible publically at:  http://www.epa.gov/oppefed1/models/terrestrial/terrplant/terrplant_user_guide.html.  These models are parameterized using relevant reviewed environmental fate data and ecological toxicity studies from registrant submissions and the literature; model input values will be consistent with the most recent version of the input parameter guidance  (citation:  http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm)).
 
                     5.3.1 Measures of Effects 
 
 Measures of ecological effects are obtained from a suite of registrant-submitted guideline studies conducted with a limited number of surrogate species.  Measures of effect are based on deleterious changes in an organism as a result of chemical exposure.  Functionally, measures of effect typically used in risk assessments include changes in survival, reproduction, or growth as determined from standard laboratory toxicity tests.  The focus on these effects for quantitative risk assessment is due to their clear relationship to higher-order ecological systems such as populations, communities, and ecosystems.  Although monitoring data may also be used to provide supporting lines of evidence for the risk characterization, monitoring data is not available for this new chemical.  Commonly used laboratory-derived toxicity values include estimates of acute mortality (such as LD50, LC50, or EC50) and estimates of effects due to longer term, chronic exposures (such as the NOAEC or NOAEL).  In addition, effects other than survival, reproduction, and growth may be considered, (such as changes in biochemical, cellular, organ-level responses) but are typically used qualitatively to characterize risks since, in many cases, the relationship between these effects and higher-order processes is prone to more uncertainty.  The latter can reflect changes seen in mortality, reproduction, or growth.  In general, for a given assessment endpoint, the lowest relevant measure of effect is used in calculating the risk quotient.
  
                     5.3.1 Integration of Exposure and Effects

 The assessment endpoints can be summarized as survival, growth, and reproduction of terrestrial and aquatic receptors to include birds, mammals, reptiles, amphibian, fish, terrestrial and aquatic invertebrates and terrestrial and aquatic plants.  The response of these receptors to fenpyrazamine exposure is represented by a small number of toxicity studies on representative or surrogate species.  Hence, there is considerable uncertainty regarding the response of a receptor since data for all species potentially exposed are not available.  The lowest available measure of effect for a given assessment endpoint is used to calculate risk to accommodate for some of this inherent uncertainty.  
 
 The ecosystems selected for modeling using PRZM/EXAMS aquatic assessment and T-REX for the terrestrial animal assessment are intended to be generally representative of any aquatic or terrestrial ecosystem associated with areas where fenpyrazamine is used.  The receptors addressed by the aquatic and terrestrial risk assessments for fenpyrazamine are summarized in Table 5.  For aquatic assessments, generally fish and aquatic invertebrates in both freshwater and estuarine/marine environments are represented. For terrestrial assessments, three different size classes of small mammals are represented, along with five potential foraging categories (short grass, tall grass, broadleaf plants, fruits/pods/seed and arthropods).  For the three different size classes of birds, the same five potential foraging categories are also considered (short grass, tall grass, broadleaf plants, fruits/pods/seeds, and arthropods).  In addition, data are available so that earthworms, terrestrial non-target insects, and sediment-dwelling organisms are represented.  
 
                     5. EXPOSURE ANALYSIS

         6.1 Aquatic Exposure

Tier II Estimated Environmental Concentrations (EECs) were estimated using EFED's aquatic models PRZM (Pesticide Root Zone Model) version 3.12 (dated May 2005) and EXAMS (Exposure Analysis Modeling System) version 2.98.4.6 (dated April 2005).   PRZM is used to simulate pesticide transport as a result of runoff, erosion, and spray drift from a 10-ha agricultural field, and EXAMS considers environmental fate and transport of pesticides in surface water and predicts EECs in a standard farm pond (10,000-m[2] pond, 2-m deep), with the assumption that the small field is cropped at 100%.  Simulations are carried out with the linkage program shell, PE5.pl (dated 11/15/06), which incorporates the standard crop and orchard scenarios developed by EFED.  Table 10 shows the PRZM/EXAMS environmental fate input parameter values and related justifications.

Table 10.  Summary of PRZM/EXAMS input parameter values for physical chemical and fate properties used for fenpyrazamine surface water aquatic EECs.
                          PRZM/EXAMS Input Parameter
                             Input Value and Unit
                                    Source
Physical Chemical Properties
Molecular Weight 
331.4 g/mol
MRID 48399906
Solubility in Water 
20.4 mg/L
MRID 48399915
Vapor Pressure 
2.17 x 10[-10] torr
MRID 48399916
Henry's Law Constant 
2.28 x 10[-10] atm·m[3]/mol
EpiSuite 
HENRYWIN v. 3.20
Environmental Fate Properties
Soil-Water Partition Coefficient (Kd)
5.06 mL/g
MRID 48399919
MRID 48399922

Average of Kd values from UK Clay Loam (8.7 mL/g), UK Silt Loam (7.4 mL/g), UK Loam (4.2 mL/g), UK Loamy Sand (5.7 mL/g), NJ Silt Loam (366 mL/g) and CA Loamy Sand (585 mL/g) [1]
Hydrolysis (t1/2)
pH4:  Stable
pH7:  Stable
pH9:  10.9 days
MRID No. 48399923
Conservative default for pH7[2]
Aqueous Photolysis (t1/2)
1.64 days
MRID 48399924

Aerobic soil metabolism (t1/2)
478.09 days
MRID 48399919 [3]
MRID 48399928 [4]


Aerobic aquatic metabolism (t1/2)
551 days
Upper 90[th] percentile[4] of values  from  MRID 48399929 (18.93 and 280 days, water and sediment total system)
Anaerobic aquatic metabolism (t1/2)
36.6 days
EFED Input Parameter Guidance for one valid study (12.2 days x 3 based on water and sediment total system)
[1]  Information unavailable related to the representativeness of UK Clay Loam, UK Silt Loam, UK Loam, UK Loamy Sand, and Japan Sandy Loam soils to domestic soils. However, the UK soils were used since soils traditionally possess physical chemical characteristics similar to US soils.  Japan Sandy Loam soil not used since soils traditionally possess volcanic minerals not found widely within US soils. 
[2]  Environmentally relevant half-lives could not be determined for pH7.  Hydrolysis half lives at 25°C could not be determined from pH 7.
[3]  Information unavailable related to the representativeness of UK Loam, UK Silt Loam, and two UK Sandy Loam soils to domestic soils. However, the UK soils were used since soils traditionally possess physical chemical characteristics similar to US soils.  
[4]  The upper 90[th] percentile half life calculated as follows: t1/2 input = t1/2  + (t90, n-1 x σ)
								         n[1/2]
  where t1/2  is the mean of the set of half lives from each study, t90, n-1 is the one-sided t value for the 90[th] percentile level, σ is the standard deviation of the set of half lives determined from each study, and n is the sample size of the set of half lives determined from each study.

All crops and application methods proposed on the label for fenpyrazamine were considered in this assessment.  Various scenarios, where available, were simulated for specific crops to account for different geographical locations agricultural practices.  Many crop scenarios are available to directly address the crops listed on the label.  However, surrogate scenarios were selected in a few cases in the PRZM/EXAMS modeling approach.  For example, the NY Grape scenario is a surrogate for the bushberries and caneberries proposed uses.  The maximum application rates, minimum retreatment intervals, and number of applications specified on the label for grapes are identical to bushberries and caneberries.  In addition, the MN Sugarbeets and MI Asparagus crop scenarios were used as a surrogate to represent fenpyrazamine proposed used on ginseng.  Consistent with the label, ground and aerial applications were modeled for each crop.  The PRZM-EXAMS crop specific environmental inputs used in each crop surrogate for each new proposed treatment is shown in Table 11.





Table 11.  Crop management PRZM/EXAMS inputs used in aquatic exposure modeling.
                          PRZM/EXAMS Input Parameter
Input Value and Unit
                                    Comment
Labeled Crop, Crop Scenarios, Application Rate, Number of Applications, Retreatment Time Interval, and
Application Date 
Almonds and Pistachio
CA Almond
   * Application Rate:  0.420 kg/ha
   * 3 applications per season
   * 7 days between applications
   * Application Date:  Jan. 20
Application dates conservatively selected based on maximum rainfall climatological date at meteorological station defined in each crop scenario site after crop emergence date specified in PRZM crop scenario.

Lettuce
CA Lettuce
   * Application Rate:  0.560 kg/ha
   * 3 applications per season
   * 7 days between applications
   * Application Date:  Feb. 25



Grapes, Bushberries, and Caneberries
NY Grape
   * Application Rate:  0.560 kg/ha
   * 3 applications per season
   * 7 days between applications
   * Application Date:  Sept. 10



Strawberries
FL Strawberry
   * Application Rate:  0.560 kg/ha
   * 4 applications per season
   * 7 days between applications
   * Application Date:  Oct. 5


Ginseng
MN Sugarbeet
   * Application Rate:  0.560 kg/ha
   * 4 applications per season
   * 7 days between applications
   * Application Date:  June 20


MI Asparagus
   * Application Rate:  0.560 kg/ha
   * 4 applications per season
   * 7 days between applications
   * Application Date:  August 1



Ornamentals
MI Nursery
   * Application Rate:  1.22 kg/ha
   * 3 application per season
   * 7 days between applications
   * Application Date:  Aug. 1

NJ Nursery
   * Application Rate:  1.22 kg/ha
   * 3 application per season
   * 7 days between applications
   * Application Date:  Aug. 1

TN Nursery
   * Application Rate:  1.22 kg/ha
   * 3 application per season
   * 7 days between applications
   * Application Date:  Aug. 1


Chemical Application Method 
Aerial and Ground Applications
CAM = 2, linear foliar based on crop canopy

Application Efficiency
Aerial Applications = 0.95
Ground Applications = 0.99
EFED Model Input Parameter Guidance 
Spray Drift Fraction 
Aerial Applications = 0.05
Ground Applications = 0.01

  
Surface water one-in-ten year upper bound EECs for all scenarios are presented in Table 12 and Table 13 for aerial and ground applications, respectively.  Examples of the PRZM/EXAMS input and output files are in Appendix E.  As expected, EECs from aerial applications are higher than ground applications with peak acute EECs ranging between 10.21  -  86.60 ug /L, 21-day EECs ranging between 9.80  -  83.92 ug/L, and 60-day chronic average EECs ranging between 9.23  -  80.35 ug/L amongst all of the crop scenarios.  For ground applications, EECs are generally slightly lower than aerial applications with peak acute EECs ranging between 7.41  -  81.22 ug /L, 21-day EECs ranging between 7.34  -  78.70 ug/L, and 60-day chronic average EECs ranged from 6.88  -  75.18 ug/L.  It is important to note that concentrations of fenpyrazamine are not reduced significantly over larger averaging periods.  Please refer to Section 7.2.6.b for further details related to the uncertainties accounted for which contribute to this result.

One-in-ten year upper bound benthic pore water EECs from PRZM/EXAMS for all scenarios are presented in Table 14 and Table 15 for aerial and ground applications, respectively.  Fenpyrazamine EECs in benthic water pores were generally half of the values in surface water.  For aerial applications, peak acute EECs range between 5.92  -  47.17 ug /L, 21-day EECs range between 5.26  -  46.79 ug/L, and 60-day chronic average EECs range between 5.15  -  46.05 ug/L amongst all of the crop scenarios.  For ground applications, EECs are lower than aerial applications consistent to water column EECs with peak acute EECs ranging between 3.95  -  44.27ug /L, 21-day EECs ranging between 3.93  -  43.92 ug/L, and 60-day chronic average EECs ranged from 3.86  -  43.23 ug/L.  The modeling results for benthic water pores also do not change significantly with time.  Please refer to Section 7.2.6.b for further details related to a further characterization of these results and the uncertainties accounted for which contribute to this result.

One-in-ten year upper bound sediment EECs from EXAMS are presented in Table 16 and Table 17 for aerial and ground applications, respectively.  As expected, and consistent with other compartments, sediment concentrations resulting from aerial applications are slightly higher than sediment concentrations resulting from ground applications.  Furthermore, average concentrations do not change significantly over time.  EECs in sediment for aerial and ground applications range between 0.03  -  0.25 mg/kg over all acute and chronic exposure durations.  The concentrations in sediment are expected given fenpyrazamine's tendency to adsorb to soil and sediment given its moderate Koc values.  Furthermore, EXAMS assumes that sediment concentrations are in equilibrium with water pore concentrations. Therefore, sediment concentrations are inter-related to benthic water pore concentrations.  Please refer to Section 7.2.6.b for further details related to the uncertainties accounted for in this modeling which influence the slow decline observed in the modeled residues in the sediment and benthic water pore compartments over time.

Table 12.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in surface water (ppb) for aerial applications of fenpyrazamine.
                                     Crops
                              PRZM Crop Scenario
                                     Peak
                                    (Acute)
                            21 Day Average (Acute)
                           60-Day Average (Chronic)
Almonds
Pistachios
                                   CA Almond
                                     10.21
                                     9.80
                                     9.23
Lettuce
                                  CA Lettuce
                                     30.51
                                     29.49
                                     28.08
Grapes
Bushberries
Caneberries
                                   NY Grape
                                     25.61
                                     24.96
                                     23.95
Strawberries
                                 FL Strawberry
                                     30.92
                                     29.59
                                     26.84
Ginseng
                                 MN Sugarbeet
                                     42.65
                                     41.03
                                     38.76

                                 MI Asparagus
                                     14.30
                                     13.85
                                     13.58
Ornamentals
                                  MI Nursery
                                     61.92
                                     60.80
                                     59.69

                                  NJ Nursery
                                     86.60
                                     83.92
                                     80.35

                                  TN Nursery
                                     44.67
                                     43.50
                                     41.19
*Bold text indicate maximum values.



Table 13.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in surface water (ppb) for ground applications of fenpyrazamine.
                                     Crops
                              PRZM Crop Scenario
                                     Peak
                                    (Acute)
                            21 Day Average (Acute)
                           60-Day Average (Chronic)
Almonds
Pistachios
                                   CA Almond
                                     7.41
                                     7.34
                                     6.88
Lettuce
                                  CA Lettuce
                                     27.60
                                     26.60
                                     25.45
Grapes
Bushberries
Caneberries
                                   NY Grape
                                     21.73
                                     21.20
                                     20.26
Strawberries
                                 FL Strawberry
                                     27.42
                                     26.23
                                     23.65
Ginseng
                                 MN Sugarbeet
                                     37.50
                                     36.14
                                     34.27

                                 MI Asparagus
                                     9.98
                                     9.89
                                     9.70
Ornamentals
                                  MI Nursery
                                     56.43
                                     55.98
                                     54.99

                                  NJ Nursery
                                     81.22
                                     78.70
                                     75.18

                                  TN Nursery
                                     38.41
                                     37.30
                                     35.21
*Bold text indicate maximum values.

Table 14.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in benthic pore water (ppb) for aerial applications of fenpyrazamine.
                                     Crops
                              PRZM Crop Scenario
                                     Peak
                                    (Acute)
                            21 Day Average (Acute)
                           60-Day Average (Chronic)
Almonds
Pistachios
                                   CA Almond
                                     5.29
                                     5.26
                                     5.15
Lettuce
                                  CA Lettuce
                                     15.28
                                     15.25
                                     15.01
Grapes
Bushberries
Caneberries
                                   NY Grape
                                     15.78
                                     15.75
                                     15.58
Strawberries
                                 FL Strawberry
                                     13.22
                                     13.19
                                     13.04
Ginseng
                                 MN Sugarbeet
                                     23.13
                                     23.07
                                     22.91

                                 MI Asparagus
                                     10.63
                                     10.57
                                     10.44
Ornamentals
                                  MI Nursery
                                     38.43
                                     38.20
                                     37.12

                                  NJ Nursery
                                     47.17
                                     46.79
                                     46.05

                                  TN Nursery
                                     23.32
                                     23.24
                                     22.52
*Bold text indicate maximum values.


Table 15.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in benthic pore water (ppb) for ground applications of fenpyrazamine.
                                     Crops
                              PRZM Crop Scenario
                                     Peak
                                    (Acute)
                            21 Day Average (Acute)
                           60-Day Average (Chronic)
                                    Almonds
                                  Pistachios
                                   CA Almond
                                     3.95
                                     3.93
                                     3.86
                                    Lettuce
                                  CA Lettuce
                                     13.92
                                     13.89
                                     13.67
                                    Grapes
                                  Bushberries
                                  Caneberries
                                   NY Grape
                                     13.57
                                     13.56
                                     13.37
                                 Strawberries
                                 FL Strawberry
                                     11.55
                                     11.53
                                     11.42
                                    Ginseng
                                 MN Sugarbeet
                                     20.62
                                     20.60
                                     20.47
                                       
                                 MI Asparagus
                                     7.66
                                     7.61
                                     7.51
                                  Ornamentals
                                  MI Nursery
                                     34.30
                                     34.08
                                     33.03
                                       
                                  NJ Nursery
                                     44.27
                                     43.92
                                     43.23
                                       
                                  TN Nursery
                                     20.00
                                     19.94
                                     19.40
*Bold text indicate maximum values.

Table 16. PRZM/EXAMS estimated one-in-ten year upper bound concentrations in sediment (mg fenpyrazamine/kg sediment, dry weight) for aerial applications of fenpyrazamine.
                                     Crops
                              PRZM Crop Scenario
                                     Peak
                                    (Acute)
                            21 Day Average (Acute)
                           60-Day Average (Chronic)
Almonds
Pistachios
                                   CA Almond
                                     0.03
                                     0.03
                                     0.03
Lettuce
                                  CA Lettuce
                                     0.08
                                     0.08
                                     0.08
Grapes
Bushberries
Caneberries
                                   NY Grape
                                     0.09
                                     0.09
                                     0.09
Strawberries
                                 FL Strawberry
                                     0.07
                                     0.07
                                     0.07
Ginseng
                                 MN Sugarbeet
                                     0.13
                                     0.13
                                     0.12

                                 MI Asparagus
                                     0.06
                                     0.06
                                     0.06
Ornamentals
                                  MI Nursery
                                     0.21
                                     0.21
                                     0.20

                                  NJ Nursery
                                     0.26
                                     0.25
                                     0.25

                                  TN Nursery
                                     0.13
                                     0.13
                                     0.12
*Bold text indicate maximum values.

Table 17.  PRZM/EXAMS estimated one-in-ten year upper bound concentrations in sediment (mg fenpyrazamine/kg sediment, dry weight) for ground applications of fenpyrazamine.
                                     Crops
                              PRZM Crop Scenario
                                     Peak
                                    (Acute)
                            21 Day Average (Acute)
                           60-Day Average (Chronic)
                                    Almonds
                                  Pistachios
                                   CA Almond
                                     0.02
                                     0.02
                                     0.02
                                    Lettuce
                                  CA Lettuce
                                     0.08
                                     0.08
                                     0.07
                                    Grapes
                                  Bushberries
                                  Caneberries
                                   NY Grape
                                     0.07
                                     0.07
                                     0.07
                                 Strawberries
                                 FL Strawberry
                                     0.06
                                     0.06
                                     0.06
                                    Ginseng
                                 MN Sugarbeet
                                     0.11
                                     0.11
                                     0.11
                                       
                                 MI Asparagus
                                     0.04
                                     0.04
                                     0.04
                                  Ornamentals
                                  MI Nursery
                                     0.19
                                     0.19
                                     0.18
                                       
                                  NJ Nursery
                                     0.24
                                     0.24
                                     0.24
                                       
                                  TN Nursery
                                     0.11
                                     0.11
                                     0.11
Bold text indicate maximum values.

         6.2 Terrestrial Exposure

 
 In order to estimate risks of fenpyrazamine exposures in terrestrial environments, all exposure modeling and resulting risk conclusions will be based on maximum application rates for a given use.  Measures of exposure are based on aquatic and terrestrial models that predict estimated environmental concentrations (EECs) of fenpyrazamine.  

            6.2.1 Wildlife Dietary Exposure

Exposure estimates for terrestrial animals assumed to be in the target area or in an area exposed to spray drift are derived from using the T-REX model (Version 1.5, released 03/2012).   This model incorporates the Kenaga nomogram, as modified by Fletcher et al. (1994), which is based on a large set of actual field residue data.  The upper limit values from the nomograph represented the 95[th] percentile of residue values from actual field measurements (Hoerger and Kenaga, 1972).  The Fletcher et al. (1994) modifications to the Kenaga nomograph are based on field measured field residues from 249 published papers, including information on 118 species of plants, 121 pesticides, and 17 chemical classes.  The default environmental half life of 35 days is used to estimate EECs.  Table 18 and Table 19 show the estimated environmental concentrations (EECs) for the three weight classes of birds and mammals, respectively.

Table 18.  Terrestrial food item residue estimates for birds with proposed fenpyrazamine uses on various crops.
                                       
                                 20-gram bird
                                 100-gram bird
                                1000-gram bird
                           All weight classes (bird)
                                 Proposed use
                                   Food Item
                      Maximum Dose-Based EECs (mg/kg-bw)
                            Dietary-based EEC (ppm)
                              Almonds, pistachios
                                  Short grass
                                    265.82
                                    151.58
                                     67.87
                                    233.40
                                       
                                  Tall grass
                                    121.84
                                     69.48
                                     31.11
                                    106.98
                                       
                               Broadleaf plants
                                    149.53
                                     85.27
                                     38.17
                                    131.29
                                       
                               Fruits/pods/seeds
                                     16.61
                                     9.47
                                     4.24
                                     14.59
                                       
                                  Arthropods
                                    104.11
                                     59.37
                                     26.58
                                     91.42
                                    Lettuce
                                  Short grass
                                    352.03
                                    200.75
                                     89.88
                                    309.10
                                       
                                  Tall grass
                                    161.35
                                     92.01
                                     41.19
                                    141.67
                                       
                               Broadleaf plants
                                    198.02
                                    112.92
                                     50.56
                                    173.87
                                       
                               Fruits/pods/seeds
                                     22.00
                                     12.55
                                     5.62
                                     19.32
                                       
                                  Arthropods
                                    137.88
                                     78.63
                                     35.20
                                    121.06
                       Grapes, bushberries, caneberries
                                  Short grass
                                    352.03
                                    200.75
                                     89.88
                                    309.10
                                       
                                  Tall grass
                                    161.35
                                     92.01
                                     41.19
                                    141.67
                                       
                               Broadleaf plants
                                    198.02
                                    112.92
                                     50.56
                                    173.87
                                       
                               Fruits/pods/seeds
                                     22.00
                                     12.55
                                     5.62
                                     19.32
                                       
                                  Arthropods
                                    137.88
                                     78.63
                                     35.20
                                    121.06
                                 Strawberries
                                  Short grass
                                    440.40
                                    251.13
                                    112.44
                                    386.69
                                       
                                  Tall grass
                                    201.85
                                    115.10
                                     51.53
                                    177.23
                                       
                               Broadleaf plants
                                    247.72
                                    141.26
                                     63.25
                                    217.51
                                       
                               Fruits/pods/seeds
                                     27.52
                                     15.70
                                     7.03
                                     24.17
                                       
                                  Arthropods
                                    172.49
                                     98.36
                                     44.04
                                    151.45
                                   Ginseng 
                                  Short grass
                                    440.40
                                    251.13
                                    112.44
                                    386.69
                                       
                                  Tall grass
                                    201.85
                                    115.10
                                     51.53
                                    177.23
                                       
                               Broadleaf plants
                                    247.72
                                    141.26
                                     63.25
                                    217.51
                                       
                               Fruits/pods/seeds
                                     27.52
                                     15.70
                                     7.03
                                     24.17
                                       
                                  Arthropods
                                    172.49
                                     98.36
                                     44.04
                                    151.45
                                 Ornamentals 
                                  Short grass
                                    768.73
                                    438.36
                                    196.26
                                    674.98
                                       
                                  Tall grass
                                    352.33
                                    200.92
                                     89.95
                                    309.36
                                       
                               Broadleaf plants
                                    432.41
                                    246.58
                                    110.40
                                    379.67
                                       
                               Fruits/pods/seeds
                                     48.05
                                     27.40
                                     12.27
                                     42.19
                                       
                                  Arthropods
                                    301.09
                                    171.69
                                     76.87
                                    264.37

Table 19.  Terrestrial food item residue estimates for mammals with proposed fenpyrazamine uses on various crops.
                                       
                                15-gram mammal
                                35-gram mammal
                               1000-gram mammals
                          All weight classes (mammal)
                                 Proposed use
                                   Food Item
                      Maximum Dose-Based EECs (mg/kg-bw)
                            Dietary-based EEC (ppm)
                              Almonds, pistachios
                                  Short grass
                                    222.53
                                    153.80
                                     35.66
                                    233.40
                                       
                                  Tall grass
                                    101.99
                                     70.49
                                     16.34
                                    106.98
                                       
                               Broadleaf plants
                                    125.17
                                     86.51
                                     20.06
                                    131.29
                                       
                               Fruits/pods/seeds
                                     13.91
                                     9.61
                                     2.23
                                     14.59
                                       
                                  Arthropods
                                     87.16
                                     60.24
                                     13.97
                                     91.42
                                    Lettuce
                                  Short grass
                                    294.70
                                    203.68
                                     47.22
                                    309.10
                                       
                                  Tall grass
                                    135.07
                                     93.35
                                     21.64
                                    141.67
                                       
                               Broadleaf plants
                                    165.77
                                    114.57
                                     26.56
                                    173.87
                                       
                               Fruits/pods/seeds
                                     18.42
                                     12.73
                                     2.95
                                     19.32
                                       
                                  Arthropods
                                    115.43
                                     79.77
                                     18.50
                                    121.06
                       Grapes, bushberries, caneberries
                                  Short grass
                                    294.70
                                    203.68
                                     47.22
                                    309.10
                                       
                                  Tall grass
                                    135.07
                                     93.35
                                     21.64
                                    141.67
                                       
                               Broadleaf plants
                                    165.77
                                    114.57
                                     26.56
                                    173.87
                                       
                               Fruits/pods/seeds
                                     18.42
                                     12.73
                                     2.95
                                     19.32
                                       
                                  Arthropods
                                    115.43
                                     79.77
                                     18.50
                                    121.06
                                 Strawberries
                                  Short grass
                                    368.68
                                    254.81
                                     59.08
                                    386.69
                                       
                                  Tall grass
                                    168.98
                                    116.79
                                     27.08
                                    177.23
                                       
                               Broadleaf plants
                                    207.38
                                    143.33
                                     33.23
                                    217.51
                                       
                               Fruits/pods/seeds
                                     23.04
                                     15.93
                                     3.69
                                     24.17
                                       
                                  Arthropods
                                    144.40
                                     99.80
                                     23.14
                                    151.45
                                   Ginseng 
                                  Short grass
                                    368.68
                                    254.81
                                     59.08
                                    386.69
                                       
                                  Tall grass
                                    168.98
                                    116.79
                                     27.08
                                    177.23
                                       
                               Broadleaf plants
                                    207.38
                                    143.33
                                     33.23
                                    217.51
                                       
                               Fruits/pods/seeds
                                     23.04
                                     15.93
                                     3.69
                                     24.17
                                       
                                  Arthropods
                                    144.40
                                     99.80
                                     23.14
                                    151.45
                                 Ornamentals 
                                  Short grass
                                    643.54
                                    444.77
                                    103.12
                                    674.98
                                       
                                  Tall grass
                                    294.95
                                    203.85
                                     47.26
                                    309.36
                                       
                               Broadleaf plants
                                    361.99
                                    250.18
                                     58.01
                                    379.67
                                       
                               Fruits/pods/seeds
                                     40.22
                                     27.80
                                     6.45
                                     42.19
                                       
                                  Arthropods
                                    252.05
                                    174.20
                                     40.39
                                    264.37

            6.2.2 Terrestrial Plant Exposure

 The model used to predict terrestrial and wetland plants is TerrPlant (version 1.2.2, released 12/2006).  EECs for terrestrial plants inhabiting dry and wetland areas are derived using this model which utilizes the solubility of pesticide in runoff and in spray drift.  Additionally, TerrPlant derived EECs factor in application rate and minimum incorporation depth.  Table 20 summarizes the EECs resulting from the proposed uses of fenpyrazamine.
 
Table 20.  TerrPlant derived EECs for dry and semi-aquatic areas resulting from proposed fenpyrazamine uses.
                                      Crop
                    Single Max Application Rate (lbs a.i/A)
                              Description of Area
                                      EEC
                                   (lbs a.i/A
                              Almonds, Pistachios
                                     0.37 
                              Runoff to  Dry areas
                                     0.007
                                        
                                        
                          Runoff to semi-aquatic areas
                                      0.07
                                        
                                        
                                  Spray drift
                                      0.02
                                        
                                        
                              Total for dry areas
                                      0.03
                                        
                                        
                          Total for semi-aquatic areas
                                      0.09
        Lettuce, Grapes, Bushberries, Caneberries, Strawberries, Ginseng
                                      0.49
                              Runoff to  Dry areas
                                      0.01
                                        
                                        
                          Runoff to semi-aquatic areas
                                      0.10
                                        
                                        
                                  Spray drift
                                      0.02
                                        
                                        
                              Total for dry areas
                                      0.3
                                        
                                        
                          Total for semi-aquatic areas
                                      0.12
                                  Ornamentals
                                      1.07
                              Runoff to  Dry areas
                                      0.02
                                        
                                        
                          Runoff to semi-aquatic areas
                                      0.02
                                        
                                        
                                  Spray drift
                                      0.05
                                        
                                        
                              Total for dry areas
                                      0.07
                                        
                                        
                          Total for semi-aquatic areas
                                      0.27
 
                     5. RISK CHARACTERIZATION
 
Risk characterization is the integration of exposure and effects characterization to determine the ecological risk from the use of fenpyrazamine and the likelihood of effects on aquatic life, wildlife, and plants based on varying pesticide-use scenarios.  The risk characterization provides estimation and a description of the risk; articulates risk assessment assumptions, limitations, and uncertainties; synthesizes an overall conclusion; and provides the risk managers with information to make regulatory decisions.
         7.1 Risk Estimation - Integration of Exposure and Effects Data  
 	
 Results of the exposure and toxicity effects data are used to evaluate the likelihood of adverse ecological effects on non-target species.  For the assessment of fenpyrazamine risks, the risk quotient method is used to compare exposure and measured toxicity values (refer to Appendix E).  Estimated environmental concentrations are divided by the most sensitive acute and chronic toxicity values.  The RQs are then compared to the Agency's levels of concern. These LOCs, summarized in Appendix E, are the Agency's interpretive policy and are used to analyze potential risk to non-target organisms and the need to consider regulatory action.  These criteria are used to indicate when a pesticide's use as directed on the label has the potential to cause adverse effects on non-target organisms. 
 
                        7.1.1 Non-target Aquatic Animals and Plants 
 
To assess risk of fenpyrazamine to non-target aquatic animals and plants, surface water, pore water and sediment EECs for fenpyrazamine were obtained from the Tier 2 model PRZM/EXAMS based on the label-recommended usage scenarios Table 3 

                     a. Water Column Exposure: Acute and Chronic Risk to Animals 
 
   * Fish
 
 Maximum acute and chronic RQs for freshwater and estuarine/marine fish are determined from the peak and 60-d average EECs and the appropriate toxicity reference values (Table 7).  Table 21 summarizes the acute and chronic RQs for freshwater and estuarine/marine fish in the water column with the EECs and toxicological endpoints that they were derived from.  For estuarine/marine fish, both the most sensitive acute and chronic endpoints were non-definitive.  In the case of acute exposure, a 96-hr LC50 of >3900 ug a.i/L (>3.9 mg a.i/L) was determined and therefore resultant RQs would also be non-definitive but represent the greatest measure of risk for a given application method on a given crop.  For example, a peak EEC of 30 ug a.i/L and a 96-hr LC50 -  of >3900 ug a.i/L would yield an RQ of <0.008, that is, the RQ for this use would be at most 0.008 but how far it actually falls below that value is an uncertainty.  Conversely, for chronic exposure to estuarine/marine fish, a NOAEC value was determined to be <39 ug a.i/L and therefore resultant RQs would also be non-definitive but represent the lowest measure of risk for a given application method on a given crop.  For example a 60-day EEC of 20 ug a.i/L and a NOAEC value of <39 ug a.i/L would yield an RQ of >0.51, that is, the RQ for this use would be at least 0.51, but how far it actually falls above that value is an uncertainty.  
 
 For freshwater fish, acute RQs ranged from 0.001 (ground applications to almonds and pistachios) to 0.017 (aerial applications for ornamentals), all below the acute endangered species, acute restricted use, and acute non-listed species LOCs.  Chronic RQs ranged from 0.02  (ground application to almonds and pistachios) to 0.22 (aerial application to ornamentals), which are all below the chronic risk LOC of 1.
 
 For estuarine/marine fish, acute and chronic RQs resulted from non-definitive toxicity endpoints and therefore the actual RQs are not known with certainty.  The uncertainty in these upper and lower bound RQs are discussed further in the Risk Description, Section 7.2.1.
 
Table 21.  Acute and chronic RQs for evaluating risk of fenpyrazamine exposure to freshwater and estuarine/marine fish.   
                                     Crop
                                (PRZM Scenario)
                                     Taxa
                              Application Method
                                      EEC
                                     Peak
                                 (ug a.i./L)
                                      EEC
                                    60-Day
                                 (ug a.i./L)
                                     LC50
                                 (ug a.i./L)
                                     NOAEC
                                 (ug a.i./L) 
                           Acute RQ (Peak EEC/LC50)
                                    Chronic
                                      RQ
                              (60-day EEC/NOAEC)
                                    Almonds
                                  (CA Almond)
                                Freshwater fish
                                    Aerial
                                     10.21
                                     9.23
                                     5200
                                      370
                                     0.002
                                     0.02
                                       
                                       
                                    Ground
                                     7.41
                                     6.88
                                       
                                       
                                     0.001
                                     0.02
                                       
                             Estuarine/marine fish
                                    Aerial
                                     10.21
                                     9.23
                                   >3900
                                    <39
                                   <0.003
                                   >0.24
                                       
                                       
                                    Ground
                                     7.41
                                     6.88
                                       
                                       
                                   <0.002
                                   >0.18
                                  Pistachios
                                  (CA Almond)
                                Freshwater fish
                                    Aerial
                                     10.21
                                     9.23
                                     5200
                                      370
                                     0.002
                                     0.02
                                       
                                       
                                    Ground
                                     7.41
                                     6.88
                                       
                                       
                                     0.001
                                     0.02
                                       
                             Estuarine/marine fish
                                    Aerial
                                     10.21
                                     9.23
                                   >3900
                                    <39
                                   <0.003
                                   >0.24
                                       
                                       
                                    Ground
                                     7.41
                                     6.88
                                       
                                       
                                   <0.002
                                   >0.18
                                    Lettuce
                                 (CA Lettuce)
                                Freshwater fish
                                    Aerial
                                     30.51
                                     28.08
                                     5200
                                      370
                                     0.006
                                     0.08
                                       
                                       
                                    Ground
                                     27.6
                                     25.45
                                       
                                       
                                     0.005
                                     0.07
                                       
                             Estuarine/marine fish
                                    Aerial
                                     30.51
                                     28.08
                                   >3900
                                    <39
                                   <0.008
                                   >0.72
                                       
                                       
                                    Ground
                                     27.6
                                     25.45
                                       
                                       
                                   <0.007
                                   >0.65
                                    Grapes
                                  (NY Grapes)
                                Freshwater fish
                                    Aerial
                                     25.61
                                     23.95
                                     5200
                                      370
                                     0.005
                                     0.06
                                       
                                       
                                    Ground
                                     21.73
                                     20.26
                                       
                                       
                                     0.004
                                     0.05
                                       
                             Estuarine/marine fish
                                    Aerial
                                     25.61
                                     23.95
                                   >3900
                                    <39
                                   <0.007
                                   >0.61
                                       
                                       
                                    Ground
                                     21.73
                                     20.26
                                       
                                       
                                   <0.006
                                   >0.52
                           Bushberries (NY Grapes) 
                                Freshwater fish
                                    Aerial
                                     25.61
                                     23.95
                                     5200
                                      370
                                     0.005
                                     0.06
                                       
                                       
                                    Ground
                                     21.73
                                     20.26
                                       
                                       
                                     0.004
                                     0.05
                                       
                             Estuarine/marine fish
                                    Aerial
                                     25.61
                                     23.95
                                   >3900
                                    <39
                                   <0.007
                                   >0.61
                                       
                                       
                                    Ground
                                     21.73
                                     20.26
                                       
                                       
                                   <0.006
                                   >0.52
                            Caneberries (NY Grapes)
                                Freshwater fish
                                    Aerial
                                     25.61
                                     23.95
                                     5200
                                      370
                                     0.005
                                     0.06
                                       
                                       
                                    Ground
                                     21.73
                                     20.26
                                       
                                       
                                     0.004
                                     0.05
                                       
                             Estuarine/marine fish
                                    Aerial
                                     25.61
                                     23.95
                                   >3900
                                    <39
                                   <0.007
                                   >0.61
                                       
                                       
                                    Ground
                                     21.73
                                     20.26
                                       
                                       
                                   <0.006
                                   >0.52
                                 Strawberries
                                (FL Strawberry)
                                Freshwater fish
                                    Aerial
                                     30.92
                                     26.84
                                     5200
                                      370
                                     0.006
                                     0.07
                                       
                                       
                                    Ground
                                     27.42
                                     23.65
                                       
                                       
                                     0.005
                                     0.06
                                       
                             Estuarine/marine fish
                                    Aerial
                                     30.92
                                     26.84
                                   >3900
                                    <39
                                   <0.008
                                   >0.69
                                       
                                       
                                    Ground
                                     27.42
                                     23.65
                                       
                                       
                                   <0.007
                                   >0.61
                                   Ginseng 
                                (MN Sugarbeet)
                                Freshwater fish
                                    Aerial
                                     42.65
                                     38.76
                                     5200
                                      370
                                     0.008
                                     0.10
                                       
                                       
                                    Ground
                                     37.5
                                     34.27
                                       
                                       
                                     0.007
                                     0.09
                                       
                             Estuarine/marine fish
                                    Aerial
                                     42.65
                                     38.76
                                   >3900
                                    <39
                                   <0.011
                                   >0.99
                                       
                                       
                                    Ground
                                     37.5
                                     34.27
                                       
                                       
                                   <0.010
                                   >0.88
                                   Ginseng 
                                (MI Asparagus)
                                Freshwater fish
                                    Aerial
                                     14.3
                                     13.58
                                     5200
                                      370
                                     0.003
                                     0.04
                                       
                                       
                                    Ground
                                     9.98
                                      9.7
                                       
                                       
                                     0.002
                                     0.03
                                       
                             Estuarine/marine fish
                                    Aerial
                                     14.3
                                     13.58
                                   >3900
                                    <39
                                   <0.004
                                   >0.35
                                       
                                       
                                    Ground
                                     9.98
                                      9.7
                                       
                                       
                                   <0.003
                                   >0.25
                                  Ornamentals
                                 (MI Nursery)
                                Freshwater fish
                                    Aerial
                                     61.92
                                     59.69
                                     5200
                                      370
                                     0.012
                                     0.16
                                       
                                       
                                    Ground
                                     56.43
                                     54.99
                                       
                                       
                                     0.011
                                     0.15
                                       
                             Estuarine/marine fish
                                    Aerial
                                     61.92
                                     59.69
                                   >3900
                                    <39
                                   <0.016
                                   >1.53
                                       
                                       
                                    Ground
                                     56.43
                                     54.99
                                       
                                       
                                   <0.014
                                   >1.41
                                  Ornamentals
                                 (NJ Nursery)
                                Freshwater fish
                                    Aerial
                                     86.6
                                     80.35
                                     5200
                                      370
                                     0.017
                                     0.22
                                       
                                       
                                    Ground
                                     81.22
                                     75.18
                                       
                                       
                                     0.016
                                     0.20
                                       
                             Estuarine/marine fish
                                    Aerial
                                     86.6
                                     80.35
                                   >3900
                                    <39
                                   <0.022
                                   >2.06
                                       
                                       
                                    Ground
                                     81.22
                                     75.18
                                       
                                       
                                   <0.021
                                   >1.93
                                  Ornamentals
                                 (TN Nursery)
                                Freshwater fish
                                    Aerial
                                     44.67
                                     41.19
                                     5200
                                      370
                                     0.009
                                     0.11
                                       
                                       
                                    Ground
                                     38.41
                                     35.21
                                       
                                       
                                     0.007
                                     0.10
                                       
                             Estuarine/marine fish
                                    Aerial
                                     44.67
                                     41.19
                                   >3900
                                    <39
                                   <0.011
                                   >1.06
                                       
                                       
                                    Ground
                                     38.41
                                     35.21
                                       
                                       
                                   <0.010
                                   >0.90
Bolded values represent LOC exceedances.
LOCs are: acute endangered species = 0.05; acute restricted use = 0.1; acute high risk = 0.5; chronic risk = 1
      
   * Aquatic Invertebrates-Water Column

 Maximum acute and chronic RQs for aquatic invertebrates are determined from the peak and 21-d average EECs and the appropriate toxicity reference values (Table 7).  Table 22 summarizes the acute and chronic RQs for freshwater and estuarine/marine invertebrates in the water column. Acute RQs for freshwater invertebrates ranged from 0.001 (ground application to almonds and pistachios) to 0.02 (aerial application to ornamentals), both of which are below all the acute LOCs.  Chronic RQs to freshwater fish ranged from 0.02 (ground application to almonds and pistachios) to 0.25 (aerial applications to ornamentals), both of which are below the chronic LOC of 1.

Acute RQs for estuarine/marine invertebrates ranged from 0.01 (ground application to almonds and pistachios) to 0.11 (aerial application to ornamentals, NJ scenario), the highest of which is above the acute restricted use LOC.  Aerial and ground uses to ginseng for the MN sugarbeet scenario exceeded the acute endangered species LOC as well as for the other two scenarios for ornamentals (MI and TN nursery scenarios).  Chronic RQs for estuarine/marine invertebrates could not be estimated with certainty as they were derived from a non-definitive endpoint.  The estimates however represent a maximum upper bound estimate of risk, all of which were below the chronic LOC of 1.  The uncertainty in these upper and lower bound RQs is discussed further in the Risk Description, Section 7.2.1.

Table 22.  Acute and chronic RQs for evaluating risk of fenpyrazamine exposure to freshwater and estuarine/marine invertebrates.   
                                     Crop
                                (PRZM Scenario)
                                     Taxa
                              Application Method
                                      EEC
                                     Peak
                                 (ug a.i./L)
                                      EEC
                                    21-Day
                                 (ug a.i./L)
                                     LC50
                                 (ug a.i./L)
                                     NOAEC
                                 (ug a.i./L) 
                           Acute RQ (Peak EEC/LC50)
                                    Chronic
                                      RQ
                              (21-day EEC/NOAEC)
                                    Almonds
                                  (CA Almond)
                           Freshwater invertebrates
                                    Aerial
                                     10.21
                                      9.8
                                     5500
                                      340
                                     0.002
                                     0.03
                                       
                                       
                                    Ground
                                     7.41
                                     7.34
                                       
                                       
                                     0.001
                                     0.02
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     10.21
                                      9.8
                                      780
                                    >98
                                     0.01
                                   <0.10
                                       
                                       
                                    Ground
                                     7.41
                                     7.34
                                       
                                       
                                     0.01
                                   <0.07
                                  Pistachios
                                  (CA Almond)
                           Freshwater invertebrates
                                    Aerial
                                     10.21
                                      9.8
                                     5500
                                      340
                                     0.002
                                     0.03
                                       
                                       
                                    Ground
                                     7.41
                                     7.34
                                       
                                       
                                     0.001
                                     0.02
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     10.21
                                      9.8
                                      780
                                    >98
                                     0.01
                                   <0.10
                                       
                                       
                                    Ground
                                     7.41
                                     7.34
                                       
                                       
                                     0.01
                                   <0.07
                                    Lettuce
                                 (CA Lettuce)
                           Freshwater invertebrates
                                    Aerial
                                     30.51
                                     29.49
                                     5500
                                      340
                                     0.006
                                     0.09
                                       
                                       
                                    Ground
                                     27.6
                                     26.6
                                       
                                       
                                     0.005
                                     0.08
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     30.51
                                     29.49
                                      780
                                    >98
                                     0.04
                                   <0.30
                                       
                                       
                                    Ground
                                     27.6
                                     26.6
                                       
                                       
                                     0.04
                                       
                                   <0.27
                                       
                                    Grapes
                                  (NY Grapes)
                           Freshwater invertebrates
                                    Aerial
                                     25.61
                                     24.96
                                     5500
                                      340
                                     0.005
                                     0.07
                                       
                                       
                                    Ground
                                     21.73
                                     21.2
                                       
                                       
                                     0.004
                                     0.06
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     25.61
                                     24.96
                                      780
                                    >98
                                     0.03
                                   <0.25
                                       
                                       
                                    Ground
                                     21.73
                                     21.2
                                       
                                       
                                     0.03
                                   <0.22
                           Bushberries (NY Grapes) 
                           Freshwater invertebrates
                                    Aerial
                                     25.61
                                     24.96
                                     5500
                                      340
                                     0.005
                                     0.07
                                       
                                       
                                    Ground
                                     21.73
                                     21.2
                                       
                                       
                                     0.004
                                     0.06
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     25.61
                                     24.96
                                      780
                                    >98
                                     0.03
                                   <0.25
                                       
                                       
                                    Ground
                                     21.73
                                     21.2
                                       
                                       
                                     0.03
                                   <0.22
                            Caneberries (NY Grapes)
                           Freshwater invertebrates
                                    Aerial
                                     25.61
                                     24.96
                                     5500
                                      340
                                     0.005
                                     0.07
                                       
                                       
                                    Ground
                                     21.73
                                     21.2
                                       
                                       
                                     0.004
                                     0.06
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     25.61
                                     24.96
                                      780
                                    >98
                                     0.03
                                   <0.25
                                       
                                       
                                    Ground
                                     21.73
                                     21.2
                                       
                                       
                                     0.03
                                   <0.22
                                 Strawberries
                                (FL Strawberry)
                           Freshwater invertebrates
                                    Aerial
                                     30.92
                                     29.59
                                     5500
                                      340
                                     0.006
                                     0.09
                                       
                                       
                                    Ground
                                     27.42
                                     26.23
                                       
                                       
                                     0.005
                                     0.08
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     30.92
                                     29.59
                                      780
                                    >98
                                     0.04
                                   <0.30
                                       
                                       
                                    Ground
                                     27.42
                                     26.23
                                       
                                       
                                     0.04
                                   <0.27
                                   Ginseng 
                                (MN Sugarbeet)
                           Freshwater invertebrates
                                    Aerial
                                     42.65
                                     41.03
                                     5500
                                      340
                                     0.008
                                     0.12
                                       
                                       
                                    Ground
                                     37.5
                                     36.14
                                       
                                       
                                     0.007
                                     0.11
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     42.65
                                     41.03
                                      780
                                    >98
                                     0.06
                                   <0.42
                                       
                                       
                                    Ground
                                     37.5
                                     36.14
                                       
                                       
                                     0.05
                                   <0.37
                                   Ginseng 
                                (MI Asparagus)
                           Freshwater invertebrates
                                    Aerial
                                     14.3
                                     13.85
                                     5500
                                      340
                                     0.003
                                     0.04
                                       
                                       
                                    Ground
                                     9.98
                                     9.89
                                       
                                       
                                     0.002
                                     0.03
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     14.3
                                     13.85
                                      780
                                    >98
                                     0.02
                                   <0.14
                                       
                                       
                                    Ground
                                     9.98
                                     9.89
                                       
                                       
                                     0.01
                                   <0.10
                                  Ornamentals
                                 (MI Nursery)
                           Freshwater invertebrates
                                    Aerial
                                     61.92
                                     60.8
                                     5500
                                      340
                                     0.01
                                     0.18
                                       
                                       
                                    Ground
                                     56.43
                                     55.98
                                       
                                       
                                     0.01
                                     0.16
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     61.92
                                     60.8
                                      780
                                    >98
                                     0.08
                                   <0.62
                                       
                                       
                                    Ground
                                     56.43
                                     55.98
                                       
                                       
                                     0.07
                                   <0.57
                                  Ornamentals
                                 (NJ Nursery)
                           Freshwater invertebrates
                                    Aerial
                                     86.6
                                     83.92
                                     5500
                                      340
                                     0.02
                                     0.25
                                       
                                       
                                    Ground
                                     81.22
                                     78.7
                                       
                                       
                                     0.02
                                     0.23
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     86.6
                                     83.92
                                      780
                                    >98
                                     0.11
                                   <0.86
                                       
                                       
                                    Ground
                                     81.22
                                     78.7
                                       
                                       
                                     0.10
                                   <0.80
                                  Ornamentals
                                 (TN Nursery)
                           Freshwater invertebrates
                                    Aerial
                                     44.67
                                     43.5
                                     5500
                                      340
                                     0.008
                                     0.13
                                       
                                       
                                    Ground
                                     38.41
                                     37.3
                                       
                                       
                                     0.007
                                     0.11
                                       
                        Estuarine/marine invertebrates
                                    Aerial
                                     44.67
                                     43.5
                                      780
                                    >98
                                     0.06
                                   <0.44
                                       
                                       
                                    Ground
                                     38.41
                                     37.3
                                       
                                       
                                     0.05
                                   <0.38
Bolded values represent LOC exceedances.
LOCs are: acute endangered species = 0.05; acute restricted use = 0.1; acute high risk = 0.5; chronic risk = 1
                     a. Sediment Exposure: Chronic Risk to Benthic Invertebrates 
 
 Comparisons of EECs and sediment toxicity endpoints are provided below to supplement risk estimation to water column organisms. The evaluation of toxic risk to the benthic organisms was approached by assuming equilibrium partitioning fenpyrazamine between the sediment and the pore water (the water found between particulates in the sediment).  Risk to benthic organisms was assessed using two approaches: (1) EECs for sediment were model-generated (PRZM/EXAMS) and compared to the toxicity value as reported for sediment exposure (NOAEC) in the sediment toxicity tests (normalized to organic carbon) and (2) EECs for pore water were model-generated (PRZM/EXAMS) and compared to the toxicity value as reported for pore water (NOAEC) in the sediment toxicity tests.  
 
As discussed in Section 4.4.1 of this assessment, there were three chronic sediment toxicity studies submitted in support of fenpyrazamine.  The duration of these three toxicity studies range from 28 to 42 days.  For estimating sediment and pore water RQs for benthic invertebrates, the PRZM/EXAMS 21-day averages for sediment and pore water EECs will be used along with the respective sediment and pore water NOAEC endpoints for the sediment toxicity studies.  The 21-day average EECs for sediment and pore water resulting from the proposed uses of fenpyrazamine, as well as the chronic NOAEC values from the sediment toxicity studies and their resultant RQs can be found below in Table 23 for freshwater benthic invertebrates and Table 24 for estuarine/marine benthic invertebrates.

For freshwater and estuarine/marine benthic invertebrates, chronic RQs were estimated from non-definitive toxicity endpoints and therefore the actual RQs are not known with certainty.  Preliminary analysis shows the chronic LOC of 1 is exceeded with certainty with freshwater invertebrates for the ginseng (MN sugarbeet) use and all scenarios conducted for the ornamental use.  These exceedances of the chronic LOC of 1 are true for both sediment-based RQ and pore-water based RQs.   For estuarine/marine benthic invertebrates the LOC of 1 is not exceeded with certainty for all proposed uses of fenpyrazamine but where exactly the RQ falls is an uncertainty.  The uncertainty in these upper and lower bound RQs are discussed further in the Risk Description, Section 7.2.1.
 
Table 23.  Chronic RQs for risk of fenpyrazamine exposure to freshwater benthic invertebrates[1][,2].  
                                     Crop
                              (Specific scenario)
                              Application Method
                                       
                                 Sediment EEC
                            (ug a.i./ kg sediment)
                                Pore Water EEC
                            (ug a.i./L pore water)
                         NOAEC  (ug a.i./kg sediment)
                                       
                         NOAEC (ug a.i./L pore water)
                                       
                                   Sediment
                                      RQ
                                       
                                       
                                  Pore water
                                      RQ
                                       
                              Almonds, Pistachios
                                    Ground
                                      30
                                     5.26
                                    <101
                                    <20
                                   >0.30
                                   >0.26
                                       
                                    Aerial
                                      20
                                     3.93
                                       
                                       
                                   >0.20
                                   >0.20
                                    Lettuce
                                    Ground
                                      80
                                     15.25
                                       
                                       
                                   >0.79
                                   >0.76
                                       
                                    Aerial
                                      80
                                     13.89
                                       
                                       
                                   >0.79
                                   >0.69
                       Grapes, Bushberries, Caneberries
                                    Ground
                                      90
                                     15.75
                                       
                                       
                                   >0.89
                                   >0.79
                                       
                                    Aerial
                                      70
                                     13.56
                                       
                                       
                                   >0.69
                                   >0.68
                                 Strawberries
                                    Ground
                                      70
                                     13.19
                                       
                                       
                                   >0.69
                                   >0.66
                                       
                                    Aerial
                                      60
                                     11.53
                                       
                                       
                                   >0.59
                                   >0.58
                                    Ginseng
                                (MN Sugarbeet)
                                    Ground
                                      130
                                     23.07
                                       
                                       
                                   >1.29
                                   >1.15
                                       
                                    Aerial
                                      110
                                     20.6
                                       
                                       
                                   >1.09
                                   >1.03
                            Ginseng (MI asparagus)
                                    Ground
                                      60
                                     10.57
                                       
                                       
                                   >0.59
                                   >0.53
                                       
                                    Aerial
                                      40
                                     7.61
                                       
                                       
                                   >0.40
                                   >0.38
                                       
                                   Ornamental
                                  (MI Nursery)
                                    Ground
                                      210
                                     38.2
                                        
                                        
                                   >2.08
                                   >1.91
                                        
                                    Aerial
                                      190
                                     34.08
                                        
                                        
                                   >1.88
                                   >1.70
                                  Ornamental 
                                  (NJ Nursery)
                                    Ground
                                      250
                                     46.79
                                        
                                        
                                   >2.48
                                   >2.34
                                        
                                    Aerial
                                      240
                                     43.92
                                        
                                        
                                   >2.38
                                   >2.20
                                   Ornamental
                                  (TN Nursery)
                                    Ground
                                      130
                                     23.24
                                        
                                        
                                   >1.29
                                   >1.16
                                        
                                    Aerial
                                      110
                                     19.94
                                        
                                        
                                   >1.09
                                   >1.00
 [1]Using 101 ug a.i/kg sediment and 20 ug a.i/L as upper bound estimates of sediment and pore water toxicity, respectively.
 [2]PRZM/EXAMS 21-day average EECs will be used for estimation of RQs.
 Bolded values represent RQs exceeding the chronic aquatic organism RQ of 1.
 
 
Table 24.  Chronic RQs for risk of fenpyrazamine exposure to estuarine/marine benthic invertebrates[1][,2][,3].  
                                     Crop
                              (Specific scenario)
                              Application Method
                                       
                                 Sediment EEC
                            (ug a.i./ kg sediment)
                                Pore Water EEC
                            (ug a.i./L pore water)
                        NOAEC,  (ug a.i./kg sediment)
                                       
                         NOAEC (ug a.i./L pore water)
                                       
                                   Sediment
                                      RQ
                                       
                                       
                                  Pore water
                                      RQ
                                       
                              Almonds, Pistachios
                                    Ground
                                      30
                                     5.26
                                   <3000
                                    <250
                                   >0.01
                                   >0.02
                                       
                                    Aerial
                                      20
                                     3.93
                                       
                                       
                                   >0.01
                                   >0.02
                                    Lettuce
                                    Ground
                                      80
                                     15.25
                                       
                                       
                                   >0.03
                                   >0.06
                                       
                                    Aerial
                                      80
                                     13.89
                                       
                                       
                                   >0.03
                                   >0.06
                       Grapes, Bushberries, Caneberries
                                    Ground
                                      90
                                     15.75
                                       
                                       
                                   >0.03
                                   >0.06
                                       
                                    Aerial
                                      70
                                     13.56
                                       
                                       
                                   >0.02
                                   >0.05
                                 Strawberries
                                    Ground
                                      70
                                     13.19
                                       
                                       
                                   >0.02
                                   >0.05
                                       
                                    Aerial
                                      60
                                     11.53
                                       
                                       
                                   >0.02
                                   >0.05
                                    Ginseng
                                (MN Sugarbeet)
                                    Ground
                                      130
                                     23.07
                                       
                                       
                                   >0.04
                                   >0.09
                                       
                                    Aerial
                                      110
                                     20.6
                                       
                                       
                                   >0.04
                                   >0.08
                                    Ginseng
                                    Ground
                                      60
                                     10.57
                                       
                                       
                                   >0.02
                                   >0.04
                                       
                                    Aerial
                                      40
                                     7.61
                                       
                                       
                                   >0.01
                                   >0.03
                                   Ornamental
                                  (MI Nursery)
                                    Ground
                                      210
                                     38.2
                                        
                                        
                                   >0.07
                                   >0.15
                                        
                                    Aerial
                                      190
                                     34.08
                                        
                                        
                                   >0.06
                                   >0.14
                                  Ornamental 
                                  (NJ Nursery)
                                    Ground
                                      250
                                     46.79
                                        
                                        
                                   >0.08
                                   >0.19
                                        
                                    Aerial
                                      240
                                     43.92
                                        
                                        
                                   >0.08
                                   >0.18
                                   Ornamental
                                  (TN Nursery)
                                    Ground
                                      130
                                     23.24
                                        
                                        
                                   >0.04
                                   >0.09
                                        
                                    Aerial
                                      110
                                     19.94
                                        
                                        
                                   >0.04
                                   >0.08
 1Using 3 mg a.i/kg sediment and 0.25 mg a.i/L as upper bound estimates of sediment and pore water toxicity, respectively.
 [2]PRZM/EXAMS 21-day average EECs will be used for estimation of RQs.
 [3]Chronic aquatic LOC is 1.

                     a. Aquatic Plants 
 
 RQs were estimated for listed and non-listed vascular and non-vascular (algae) plants.  The most sensitive EC50 values for vascular and non-vascular plants were used with the peak EEC for all proposed uses of fenpyrazamine to yield non-listed aquatic plant RQs.  Similarly, the most sensitive NOAEC values for vascular and non-vascular plants were with the peak EECs to yield listed aquatic plant RQs.  The LOC for both listed and non-listed aquatic plants is 1.  Table 25 below summarizes the peak EECs for each use, as well as the most sensitive EC50 and NOAEC values from available toxicity studies.  For the proposed uses of fenpyrazamine, there were no non-listed vascular plant LOC exceedances (RQs ranged from 0.001  -  0.08) and for non-vascular plants, all but two uses (almonds and pistachios) exceeded the non-listed LOC (RQs ranged from 0.67  -  7.87).  For listed aquatic plants, there was a similar trend with no vascular plant LOC exceedances (RQs ranged from 0.01  -  0.14) and non-vascular aquatic plant exceedances for all proposed uses (RQs ranged from 1.51  -  17.67)
 	
Table 25.  RQs for evaluating toxic risk of fenpyrazamine exposure to vascular and non-vascular aquatic plants. 
                                     Crop
                                (PRZM Scenario)
                                     Taxa
                              Application Method
                                    EEC[c]
                                     Peak
                                 (ug a.i./L)
                                     EC50
                                 (ug a.i./L)
                                     NOAEC
                                 (ug a.i./L) 
                 Non-listed aquatic plants RQ (Peak EEC/EC50)
                           Listed aquatic plants RQ
                           (Peak EEC/NOAEC or EC05)
                                    Almonds
                                  (CA Almond)
                          Nonvascular aquatic plants
                                    Aerial
                                     10.21
                                      11
                                      4.9
                                     0.93
                                     2.08
                                       
                                       
                                    Ground
                                     7.41
                                       
                                       
                                     0.67
                                     1.51
                                       
                            Vascular aquatic plants
                                    Aerial
                                     10.21
                                     1100
                                      600
                                     0.01
                                     0.02
                                       
                                       
                                    Ground
                                     7.41
                                       
                                       
                                     0.01
                                     0.01
                                  Pistachios
                                  (CA Almond)
                          Nonvascular aquatic plants
                                    Aerial
                                     10.21
                                      11
                                      4.9
                                     0.93
                                     2.08
                                       
                                       
                                    Ground
                                     7.41
                                       
                                       
                                     0.67
                                     1.51
                                       
                            Vascular aquatic plants
                                    Aerial
                                     10.21
                                     1100
                                      600
                                     0.01
                                     0.02
                                       
                                       
                                    Ground
                                     7.41
                                       
                                       
                                     0.01
                                     0.01
                                    Lettuce
                                 (CA Lettuce)
                          Nonvascular aquatic plants
                                    Aerial
                                     30.51
                                      11
                                      4.9
                                     2.77
                                     6.23
                                       
                                       
                                    Ground
                                     27.6
                                       
                                       
                                     2.51
                                     5.63
                                       
                            Vascular aquatic plants
                                    Aerial
                                     30.51
                                     1100
                                      600
                                     0.03
                                     0.05
                                       
                                       
                                    Ground
                                     27.6
                                       
                                       
                                     0.03
                                       
                                       
                                     0.05
                                       
                                       
                                       
                                    Grapes
                                  (NY Grapes)
                          Nonvascular aquatic plants
                                    Aerial
                                     25.61
                                      11
                                      4.9
                                     2.33
                                     5.23
                                       
                                       
                                    Ground
                                     21.73
                                       
                                       
                                     1.98
                                     4.43
                                       
                                       
                            Vascular aquatic plants
                                    Aerial
                                     25.61
                                     1100
                                      600
                                     0.02
                                     0.04
                                       
                                       
                                    Ground
                                     21.73
                                       
                                       
                                     0.02
                                     0.04
                           Bushberries (NY Grapes) 
                          Nonvascular aquatic plants
                                    Aerial
                                     25.61
                                      11
                                      4.9
                                     2.33
                                     5.23
                                       
                                       
                                    Ground
                                     21.73
                                       
                                       
                                     1.98
                                     4.43
                                       
                            Vascular aquatic plants
                                    Aerial
                                     25.61
                                     1100
                                      600
                                     0.02
                                     0.04
                                       
                                       
                                    Ground
                                     21.73
                                       
                                       
                                     0.02
                                     0.04
                            Caneberries (NY Grapes)
                          Nonvascular aquatic plants
                                    Aerial
                                     25.61
                                      11
                                      4.9
                                     2.33
                                     5.23
                                       
                                       
                                    Ground
                                     21.73
                                       
                                       
                                     1.98
                                     4.43
                                       
                            Vascular aquatic plants
                                    Aerial
                                     25.61
                                     1100
                                      600
                                     0.02
                                     0.04
                                       
                                       
                                    Ground
                                     21.73
                                       
                                       
                                     0.02
                                     0.04
                                 Strawberries
                                (FL Strawberry)
                                       
                                       
                                       
                          Nonvascular aquatic plants
                                    Aerial
                                     30.92
                                      11
                                      4.9
                                     2.81
                                     6.31
                                       
                                       
                                    Ground
                                     27.42
                                       
                                       
                                     2.49
                                     5.60
                                       
                            Vascular aquatic plants
                                    Aerial
                                     30.92
                                     1100
                                      600
                                     0.03
                                     0.05
                                       
                                       
                                    Ground
                                     27.42
                                       
                                       
                                     0.02
                                     0.05
                                   Ginseng 
                                (MN Sugarbeet)
                          Nonvascular aquatic plants
                                    Aerial
                                     14.3
                                      11
                                      4.9
                                     3.88
                                     8.70
                                       
                                       
                                    Ground
                                     9.98
                                       
                                       
                                     3.41
                                     7.65
                                       
                            Vascular aquatic plants
                                    Aerial
                                     14.3
                                     1100
                                      600
                                     0.04
                                     0.07
                                       
                                       
                                    Ground
                                     9.98
                                       
                                       
                                     0.03
                                     0.06
                                   Ginseng 
                                (MI Asparagus)
                          Nonvascular aquatic plants
                                    Aerial
                                     61.92
                                      11
                                      4.9
                                     1.30
                                     2.92
                                       
                                       
                                    Ground
                                     56.43
                                       
                                       
                                     0.91
                                     2.04
                                       
                            Vascular aquatic plants
                                    Aerial
                                     61.92
                                     1100
                                      600
                                     0.01
                                     0.02
                                       
                                       
                                    Ground
                                     56.43
                                       
                                       
                                     0.01
                                     0.02
                                  Ornamentals
                                 (MI Nursery)
                          Nonvascular aquatic plants
                                    Aerial
                                     86.6
                                      11
                                      4.9
                                     5.63
                                     12.64
                                       
                                       
                                    Ground
                                     81.22
                                       
                                       
                                     5.13
                                     11.52
                                       
                            Vascular aquatic plants
                                    Aerial
                                     86.6
                                     1100
                                      600
                                     0.06
                                     0.10
                                       
                                       
                                    Ground
                                     81.22
                                       
                                       
                                     0.05
                                     0.09
                                  Ornamentals
                                 (NJ Nursery)
                          Nonvascular aquatic plants
                                    Aerial
                                     44.67
                                      11
                                      4.9
                                     7.87
                                     17.67
                                       
                                       
                                    Ground
                                     38.41
                                       
                                       
                                     7.38
                                     16.58
                                       
                            Vascular aquatic plants
                                    Aerial
                                     44.67
                                     1100
                                      600
                                     0.08
                                     0.14
                                       
                                       
                                    Ground
                                     38.41
                                       
                                       
                                     0.07
                                     0.14
                                  Ornamentals
                                 (TN Nursery)
                          Nonvascular aquatic plants
                                    Aerial
                                     14.3
                                      11
                                      4.9
                                     4.06
                                     9.12
                                       
                                       
                                    Ground
                                     9.98
                                       
                                       
                                     3.49
                                     7.84
                                       
                            Vascular aquatic plants
                                    Aerial
                                     61.92
                                     1100
                                      600
                                     0.04
                                     0.07
                                       
                                       
                                    Ground
                                     56.43
                                       
                                       
                                     0.03
                                     0.06
Bolded represent LOC exceedances.
LOC for non-listed and listed aquatic plants (vascular and non-vascular) is 1.
 
 
 
 
 
 
                        7.1.1 Non-target Terrestrial Animals 
                     a. Acute and Chronic Risk to Birds 
 
 T-REX provides acute dose based RQs for three size classes of birds as well as acute and chronic dietary based RQs resulting from ingestion of six different food items exposed to fenpyrazamine.  Table 26 below summarizes the acute dose-based RQs to birds for all proposed uses of fenpyrazamine.  The acute endangered species LOC was exceeded for small birds eating short grass for all proposed uses and for medium sized birds eating short grass for all uses except almonds and pistachios.  The acute restricted use LOC was exceeded for small birds eating short grass for all uses except almonds and pistachios.  Exceedances of the endangered species and restricted use LOC from other food items were only for small birds except for the ornamental use with medium sized birds eating short grass, tall grass, and broadleaf plants.  There was one acute high risk (non-listed species) LOC exceedance which was for small birds eating short grass due to exposure from the ornamental use. 
 
Table 26.  Dose-based RQs for birds due to exposure to proposed uses of fenpyrazamine.
                                      Use
                              Size Class (grams)
                               Adjusted LD50 - 
                                    RQs[1]
                                       
                                       
                                       
                                  Short grass
                                  Tall grass
                               Broadleaf plants
                                  Fruits/pods
                                  Arthropods
                                     Seeds
                              Almonds, pistachios
                                      20
                                    1440.86
                                   <0.18
                                   <0.08
                                   <0.10
                                   <0.01
                                   <0.07
                                   <0.003
                                       
                                      100
                                    1834.29
                                   <0.08
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                   <0.001
                                       
                                     1000
                                    2591.00
                                   <0.03
                                   <0.01
                                   <0.01
                                   <0.002
                                   <0.01
                                  <0.0004
                                    Lettuce
                                      20
                                    1440.86
                                   <0.24
                                   <0.11
                                   <0.14
                                   <0.02
                                   <0.10
                                   <0.003
                                       
                                      100
                                    1834.29
                                   <0.11
                                   <0.05
                                   <0.06
                                   <0.01
                                   <0.04
                                   <0.002
                                       
                                     1000
                                    2591.00
                                   <0.03
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0005
                       Grapes, bushberries, caneberries
                                      20
                                    1440.86
                                   <0.24
                                   <0.11
                                   <0.14
                                   <0.02
                                   <0.10
                                   <0.003
                                       
                                      100
                                    1834.29
                                   <0.11
                                   <0.05
                                   <0.06
                                   <0.01
                                   <0.04
                                   <0.002
                                       
                                     1000
                                    2591.00
                                   <0.03
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0005
                                 Strawberries
                                      20
                                    1440.86
                                   <0.31
                                   <0.14
                                   <0.17
                                   <0.02
                                   <0.12
                                   <0.004
                                       
                                      100
                                    1834.29
                                   <0.14
                                   <0.06
                                   <0.08
                                   <0.01
                                   <0.05
                                   <0.002
                                       
                                     1000
                                    2591.00
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.003
                                   <0.02
                                   <0.01
                                    Ginseng
                                      20
                                    1440.86
                                   <0.31
                                   <0.14
                                   <0.17
                                   <0.02
                                   <0.12
                                   <0.004
                                       
                                      100
                                    1834.29
                                   <0.14
                                   <0.06
                                   <0.08
                                   <0.01
                                   <0.05
                                   <0.002
                                       
                                     1000
                                    2591.00
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.003
                                   <0.02
                                   <0.01
                                  Ornamentals
                                      20
                                    1440.86
                                   <0.53
                                   <0.24
                                   <0.30
                                   <0.03
                                   <0.21
                                   <0.01
                                       
                                      100
                                    1834.29
                                   <0.24
                                   <0.11
                                   <0.13
                                   <0.01
                                   <0.09
                                   <0.003
                                       
                                     1000
                                    2591.00
                                   <0.08
                                   <0.03
                                   <0.04
                                   <0.005
                                   <0.03
                                   <0.001
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5
 
 Table 27 summarizes the acute and chronic dietary based RQs for birds resulting from ingestion of five different food items exposed to fenpyrazamine.  There were no acute LOC exceedances for any of the proposed uses on fenpyrazamine.  The chronic LOC of 1 was exceeded for birds eating short grass in all proposed uses except for the use on almonds and pistachios, and for birds eating tall grass and broadleaf plants for the ornamental use only.  For both acute oral toxicity studies to birds, there were non-definitive values (>2000 mg a.i/kg-bw for both the northern bobwhite quail and canary).  
 Acute dose-based RQs for birds ranged from 0.0004  -  0.53 thus indicating a potential for acute risks to various size classes of  birds species ingesting various food items for  all proposed uses.  Acute dietary-based RQs for birds ranged from 0.2  -  0.15 indicating a potential for acute risks to endangered avian species eating short grass exposed to the ornamental use of fenpyrazamine. Chronic-dietary based RQs ranged from 0.06  -  2.72 indicating a potential for chronic risks to mammals ingesting various food items for all proposed uses except almonds and pistachios.  
 
 For both dietary toxicity studies, there were also non-definitive values (>4430 ppm) that were used to estimate RQs.  Therefore, while the estimates are shown in Table 26 and Table 27, the precise values of these acute RQs are uncertain.  The RQs summarized in Table 26 and Table 27 lists the upper bound of the acute RQ, that is, the value of risk at most for a given use.   This is still useful for risk assessment despite the uncertainties associated with non-definitive toxicity endpoints.
 
Table 27.  Dietary-based RQs for birds due to exposure to proposed uses of fenpyrazamine.
                                      Use
                                    RQs[1]
                                       
                                   Exposure
                                  Short grass
                                  Tall grass
                               Broadleaf plants
                               Fruits/pods/seeds
                                  Arthropods
                              Almonds, pistachios
                                     Acute
                                   <0.05
                                   <0.02
                                   <0.03
                                   <0.003
                                   <0.02
                                       
                                    Chronic
                                     0.94
                                     0.43
                                     0.53
                                     0.06
                                     0.37
                                    Lettuce
                                     Acute
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                       
                                    Chronic
                                     1.25
                                     0.57
                                     0.70
                                     0.08
                                     0.49
                       Grapes, bushberries, caneberries
                                     Acute
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                       
                                    Chronic
                                     1.25
                                     0.57
                                     0.70
                                     0.08
                                     0.49
                                 Strawberries
                                     Acute
                                   <0.09
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                       
                                    Chronic
                                     1.56
                                     0.71
                                     0.88
                                     0.10
                                     0.61
                                    Ginseng
                                     Acute
                                   <0.09
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                       
                                    Chronic
                                     1.56
                                     0.71
                                     0.88
                                     0.10
                                     0.61
                                  Ornamentals
                                     Acute
                                   <0.15
                                   <0.07
                                   <0.09
                                   <0.01
                                   <0.06
                                       
                                    Chronic
                                     2.72
                                     1.25
                                     1.53
                                     0.17
                                     1.07
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1
                     a. Acute and Chronic Risk to Mammals 
 
 T-REX provides acute and chronic dose- based RQs for three size classes of mammals as well as chronic dietary based RQs resulting from ingestion of six different food items exposed to fenpyrazamine.  Table 28 below summarizes the acute dose-based RQs to mammals for all proposed use of fenpyrazamine.  The acute endangered species LOC was exceeded for mammals eating short grass for only the proposed use on ornamentals.  There are no other acute dose-based LOC exceedances for mammals.  Table 29 summarizes the chronic dose-based RQs to mammals for all proposed uses.  The chronic LOC of 1 was exceeded for all size classes of mammals eating various food items for the ornamental use only.  The chronic LOC was exceeded by small and medium sized mammals eating tall grass, broadleaf plants, and arthropods was exceeded for all uses except almonds and pistachios (no exceedances) and lettuce, grapes, bushberries, and caneberries (exceedances only for small mammals).  Table 30 summarizes the chronic dietary-based RQ for all proposed uses of fenpyrazamine. There are no LOC exceedances for these RQs.
 
 Acute dose-based RQs for mammals ranged from 0.0004  -  0.15 thus indicating a potential for acute risks to endangered mammalian species ingesting short grass for the ornamental use only.  Chronic dose-based RQs ranged from 0.1  -  5.86 indicating a potential for chronic risks to mammals for all various size class ingesting various food items for all proposed uses.  There are no chronic dietary based LOC exceedances for mammals.
 
 For the acute oral toxicity study to mammals, there was a non-definitive endpoint (>2000 mg a.i/kg-bw) determined.  Therefore, while the estimates are shown in Table 28, the precise values of these acute RQs are uncertain.  The RQs summarized in Table 28 lists the upper bound of the acute RQ, that is, the value of risk at most for a given use.   This is still useful for risk assessment despite the uncertainties associated with non-definitive toxicity endpoints.
 
Table 28.  Acute dose-based RQs for mammals due to exposure to proposed uses of fenpyrazamine.
                                      Use
                              Size Class (grams)
                               Adjusted LD50 - 
                                    RQs[1]
                                       
                                       
                                       
                                  Short grass
                                  Tall grass
                               Broadleaf plants
                                  Fruits/pods
                                  Arthropods
                                     Seeds
                              Almonds, pistachios
                                      15
                                    4395.66
                                   <0.05
                                   <0.02
                                   <0.03
                                   <0.003
                                   <0.02
                                   <0.001
                                       
                                      35
                                    3556.56
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.003
                                   <0.02
                                   <0.001
                                       
                                     1000
                                    1538.32
                                   <0.02
                                   <0.01
                                   <0.01
                                   <0.001
                                   <0.01
                                  <0.0003
                                    Lettuce
                                      15
                                    4395.66
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001
                                       
                                      35
                                    3556.56
                                   <0.06
                                   <0.03
                                   <0.03
                                   <0.004
                                   <0.02
                                   <0.001
                                       
                                     1000
                                    1538.32
                                   <0.03
                                   <0.01
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0004
                       Grapes, bushberries, caneberries
                                      15
                                    4395.66
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001
                                       
                                      35
                                    3556.56
                                   <0.06
                                   <0.03
                                   <0.03
                                   <0.004
                                   <0.02
                                   <0.001
                                       
                                     1000
                                    1538.32
                                   <0.03
                                   <0.01
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0004
                                 Strawberries
                                      15
                                    4395.66
                                   <0.08
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                   <0.001
                                       
                                      35
                                    3556.56
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001
                                       
                                     1000
                                    1538.32
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.02
                                   <0.001
                                    Ginseng
                                      15
                                    4395.66
                                   <0.08
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                   <0.001
                                       
                                      35
                                    3556.56
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001
                                       
                                     1000
                                    1538.32
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.02
                                   <0.001
                                  Ornamentals
                                      15
                                    4395.66
                                   <0.15
                                   <0.07
                                   <0.08
                                   <0.01
                                   <0.06
                                   <0.002
                                       
                                      35
                                    3556.56
                                   <0.13
                                   <0.06
                                   <0.07
                                   <0.01
                                   <0.05
                                   <0.002
                                       
                                     1000
                                    1538.32
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1
 
Table 29.  Chronic dose-based RQs for mammals from exposure to proposed uses of fenpyrazamine.
                                      Use
                              Size Class (grams)
                               Adjusted LD50 - 
                                    RQs[1]
                                       
                                       
                                       
                                  Short grass
                                  Tall grass
                               Broadleaf plants
                                  Fruits/pods
                                  Arthropods
                                     Seeds
                              Almonds, pistachios
                                      15
                                    4395.66
                                     1.27
                                     0.58
                                     0.71
                                     0.08
                                     0.50
                                     0.02
                                       
                                      35
                                    3556.56
                                     1.08
                                     0.50
                                     0.61
                                     0.07
                                     0.42
                                     0.02
                                       
                                     1000
                                    1538.32
                                     0.58
                                     0.27
                                     0.33
                                     0.04
                                     0.23
                                     0.01
                                    Lettuce
                                      15
                                    4395.66
                                     1.68
                                     0.77
                                     0.94
                                     0.10
                                     0.66
                                     0.02
                                       
                                      35
                                    3556.56
                                     1.43
                                     0.66
                                     0.81
                                     0.09
                                     0.56
                                     0.02
                                       
                                     1000
                                    1538.32
                                     0.77
                                     0.35
                                     0.43
                                     0.05
                                     0.30
                                     0.01
                       Grapes, bushberries, caneberries
                                      15
                                    4395.66
                                     1.68
                                     0.77
                                     0.94
                                     0.10
                                     0.66
                                     0.02
                                       
                                      35
                                    3556.56
                                     1.43
                                     0.66
                                     0.81
                                     0.09
                                     0.56
                                     0.02
                                       
                                     1000
                                    1538.32
                                     0.77
                                     0.35
                                     0.43
                                     0.05
                                     0.30
                                     0.01
                                 Strawberries
                                      15
                                    4395.66
                                     2.10
                                     0.96
                                     1.18
                                     0.13
                                     0.82
                                     0.03
                                       
                                      35
                                    3556.56
                                     1.79
                                     0.82
                                     1.01
                                     0.11
                                     0.70
                                     0.02
                                       
                                     1000
                                    1538.32
                                     0.96
                                     0.44
                                     0.54
                                     0.06
                                     0.38
                                     0.01
                                    Ginseng
                                      15
                                    4395.66
                                     2.10
                                     0.96
                                     1.18
                                     0.13
                                     0.82
                                     0.03
                                       
                                      35
                                    3556.56
                                     1.79
                                     0.82
                                     1.01
                                     0.11
                                     0.70
                                     0.02
                                       
                                     1000
                                    1538.32
                                     0.96
                                     0.44
                                     0.54
                                     0.06
                                     0.38
                                     0.01
                                  Ornamentals
                                      15
                                    4395.66
                                     3.66
                                     1.68
                                     2.06
                                     1.44
                                     0.05
                                     0.05
                                       
                                      35
                                    3556.56
                                     3.13
                                     1.43
                                     1.76
                                     0.20
                                     1.23
                                     0.04
                                       
                                     1000
                                    1538.32
                                     1.68
                                     0.77
                                     0.94
                                     0.10
                                     0.66
                                     0.02
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1


Table 30.  Chronic dietary-based RQs for mammals due to exposure to proposed uses of fenpyrazamine.
                                      Use
                                    RQs[1]
                                       
                                   Exposure
                                  Short grass
                                  Tall grass
                               Broadleaf plants
                               Fruits/pods/seeds
                                  Arthropods
                              Almonds, pistachios
                                    Chronic
                                     0.23
                                     0.11
                                     0.13
                                     0.01
                                     0.09
                                    Lettuce
                                    Chronic
                                     0.31
                                     0.14
                                     0.17
                                     0.02
                                     0.12
                       Grapes, bushberries, caneberries
                                    Chronic
                                     0.31
                                     0.14
                                     0.17
                                     0.02
                                     0.12
                                 Strawberries
                                    Chronic
                                     0.39
                                     0.18
                                     0.22
                                     0.02
                                     0.15
                                    Ginseng
                                    Chronic
                                     0.39
                                     0.18
                                     0.22
                                     0.02
                                     0.15
                                  Ornamentals
                                    Chronic
                                     0.67
                                     0.31
                                     0.38
                                     0.04
                                     0.26
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1

                     a. Non-target Beneficial Insects
 
 The Agency does not currently conduct quantitative risk assessments for non-target beneficial insects (e.g., honeybee).  Rather, the potential exposure of honeybees to pesticides is assessed qualitatively based on laboratory data and if available, field data.  Furthermore, when used alone, fenpyrazamine, consistent with other carboxamide pyrazole fungicides, does not possess a mode of action consistent with systemic fungicides.  Therefore, potential exposure via transport within the plant to pollen and nectar is reduced.  It is also noted that fenpyrazamine is classified as practically non-toxic to honeybee (acute contact LD50 >100 ug a.i/bee) and was shown to be non-toxic at a dose of 100 ug a.i/bee in an acute oral exposure study.  Therefore, while the potential exists via exposure pathways such as spray drift to impact insects like honeybees, the limited available data show that fenpyrazamine is not shown to be toxic. 
 
                     a. Risks to Terrestrial Plants
 
 Seedling emergence and vegetative vigor studies are available for fenpyrazamine.  The estimates of exposure generated by TerrPlant and described in Section 6.2.2 were compared to estimates of toxicity to estimate RQ for listed and non listed plants in dry and semi aquatic areas.  For almonds and pistachios, the chronic LOC of 1 was exceeded for listed dicot species in semi aquatic areas.  There are no other LOC exceedances for this use.  For lettuce, grapes, bushberries, caneberries, strawberries, and ginseng, the chronic LOC of 1 was exceeded for listed dicot species in semi aquatic areas with no other LOC exceedances.  For the use on ornamentals, listed monocot species in semi aquatic areas and listed dicot areas in dry, semi aquatic, and areas resulting from spray drift all exceeded the chronic LOC.  Therefore, the potential for risk is indicated to these groups of terrestrial plants from the uses exceeding the LOC of 1. 
 
 It is important to note that the RQs summarized in Table 32 did not have EC25 endpoints input into the TerrPlant model for vegetative vigor on account of a lack of toxicity for these studies precluding that endpoint to be estimated.  Furthermore, the NOAEC for seedling emergence for dicot species was a non-definitive endpoint (<0.035 lbs a.i/A).  Additionally, the EC25 values for seedling emergence (monocot and dicot) were non definitive (>1.54 ad >0.53 for monocots and dicots, respectively).  Therefore while the RQs are summarized in Table 31, the RQs are not determined to be precise, and there exists uncertainty with these endpoints that arises from the use of non-definitive RQs.  This is detailed further as it pertains to terrestrial plants in the Risk Description, Section 7.2.3.   The complete input and output files from TerrPlant can be found in Appendix D.
 
Table 31.  RQs for terrestrial plants resulting from the propose uses of fenpyrazamine.
                                  Crop Use[1]
                                   Plant Type
                                 Listed Status
                                      Dry
                                  Semi-aquatic
                                  Spray Drift
                              Almonds, pistachios
                                    Monocot
                                   Non-listed
                                    <0.1
                                    <0.01
                                    <0.1
                                        
                                    Monocot
                                     Listed
                                      0.17
                                      0.62
                                    <0.1
                                        
                                     Dicot
                                   Non-listed
                                    <0.1
                                      0.17
                                    <0.1
                                        
                                     Dicot
                                     Listed
                                      0.74
                                      2.64
                                      0.53
        Lettuce, Grapes, Caneberries, Bushberries, Strawberries, Ginseng
                                    Monocot
                                   Non-listed
                                    <0.01
                                      0.20
                                    <0.01
                                        
                                    Monocot
                                     Listed
                                      0.23
                                      0.82
                                    <0.1
                                        
                                     Dicot
                                   Non-listed
                                    <0.01
                                      0.23
                                    <0.1
                                        
                                     Dicot
                                     Listed
                                      0.98
                                      3.50
                                      0.70
                                        
                                  Ornamentals
                                    Monocot
                                   Non-listed
                                      0.12
                                      0.45
                                    <0.1
                                        
                                    Monocot
                                     Listed
                                      0.50
                                      1.78
                                    <0.1
                                        
                                     Dicot
                                   Non-listed
                                      0.14
                                      0.50
                                      0.1
                                        
                                     Dicot
                                     Listed
                                      2.14
                                      7.64
                                      1.53
 [1]Single application rates for TerrPlant modeling are 0.37 lbs a.i/A for almonds and pistachios, 0.49 lbs a.i/A for lettuce, grapes, caneberries, bushberries, strawberries, and ginseng, and 1.07 lbs a.i/A for ornamentals
 Bolded values represent LOC exceedances of the listed and non-listed terrestrial plant LOC of 1
 
         7.1 Risk Description
 
 In risk description, the results from the risk estimation are interpreted and synthesized into overall risk conclusions. When available, other lines of evidence are considered for characterizing ecological risk (e.g., monitoring data, ecological incident reports, refined exposure and effects modeling, data for structurally similar pesticides, etc.). In the case of fenpyrazamine, no information is available on monitored concentrations in the environment or ecological incident reports because it is a new pesticide.  The risk description also contains a discussion of relevant sources of uncertainty in the risk assessment and sensitivity of the risk assessment findings to important methodological assumptions.  Those uncertainties that are specific to certain taxonomic groups are discussed in the following sections.  Those uncertainties that are generic to this assessment (i.e., extending across taxonomic groups) are described in Section 7.2.6.d. 
 
Risks to Aquatic Animals 
  
                     a.                         Potential for Acutely Toxic Exposures 
 
                  * Fish 
 
 The previous risk estimation indicates a low potential for acutely toxic exposures to freshwater and estuarine/marine fish animals from the proposed uses of fenpyrazamine.  The highest estimated acute RQs for freshwater fish are 3 times below the listed species LOC of 0.05 and the lowest RQs are one order of magnitude lower.  For acute risk to estuarine/marine fish, RQs were estimated from a non-definitive endpoint (>3900 ug a.i/L).  As a result, the RQs that were estimated represent at most what the RQ would fall but the precise value of the RQ is uncertain.  An LC50 of >3900 ug a.i./L would yield an RQ that be preceded with an "<" indicating that the estimated value would at most be the calculated RQ.  Even with the uncertainty in these RQs calculated from non-definitive endpoints, they are still useful in risk assessment in terms of serving as a screen and in this case indicate that acute risk to estuarine/marine fish is at most approximately 2 times below the listed species LOC of 0.05.  
 
 Acute toxicity data was available for two degradates of fenpyrazamine to freshwater fish (S-2188-DC and S-2188-OH).  These studies indicated that freshwater fish (using rainbow trout as a surrogate) was approximately 17 times more sensitive to parent fenpyrazamine than to these degradation products.  While there were no degradate studies to estuarine/marine fish, degradates are expected to be of lower toxicity to this taxa similar to freshwater fish as indicated by a small difference in acute LC50 values for freshwater and estuarine/marine fish (5.2 mg a.i/L and >3.9 mg a.i/L, respectively).  Significant acute exposure to degradates in the water column is not expected.  The most significant mechanism contributing to the potential input of degradation products into water bodies is anaerobic soil metabolism where degradation of fenpyrazamine of S-2188-OH and S-2188-DC occurs of levels up to 22.9 percent and 22 percent applied, respectively.  There were no other cases where degradate residues contributed to greater than 10 percent of the applied in soil.  Once in the water column, fenpyrazamine is moderately persistent to persistent in the water column, especially in acidic environments, with half-lives ranging from 12.2 days  -  280 days under aerobic and anaerobic conditions.  
 
                  * Aquatic Invertebrates
 
 A low potential for acutely toxic exposure is also indicated for freshwater and estuarine/marine invertebrates.  Freshwater invertebrate RQs at their highest are marginally close to the listed species LOC of 0.05 (NJ ornamental aerial use RQ of 0.02  Estuarine/marine invertebrates were shown to be more sensitive in ecotoxicological testing and as a result, the highest acute RQs for this taxa marginally exceed the acute restricted use  LOC of 0.1 with aerial and ground application to ornamental (NJ nursery scenario) RQs of 0.11 and 0.1.  .  For two other scenarios of the ornamental use (MI and TN nursery), there was a marginal exceedance of the listed species LOC of 0.05 (RQs = 0.08 and 0.06 for the scenarios, respectively), as well as for the ginseng use (MN sugarbeet scenario, RQ = 0.06)   Three acute toxicity studies with freshwater invertebrates (Daphnia magna) were submitted with three degradation products of fenpyrazamine (MCNI, S-2188-DC, and S-2188-OH).  The results of these studies were similar to those of the results of the freshwater fish degradate studies.  In the case of MCNI (the most toxic of the degradates) the LC50 was still approximately 10 times less toxic than parent fenpyrazamine. The degradates S-2188-DC and S-2188-OH were approximately 17 times less toxic than parent fenpyrazamine.  Although, there were no degradate studies conducted on estuarine/marine invertebrates, the degradation products are expected to be less toxic than parent fenpyrazamine to this taxa  as it was for freshwater invertebrates despite the fact that estuarine/marine invertebrates were shown to be more sensitive to parent chemical than freshwater invertebrates.  Biodegradation and abiotic degradation of fenpyrazamine in the water column and availability of degradate products to runoff as described above for fish species also suggest that exposure of degradate residues will not cause adverse impacts to aquatic invertebrates on an acute basis.
                     a. Potential for Chronically Toxic Exposures

                  * Fish 
 
Chronic toxicity studies are available for freshwater and estuarine/marine fish as early life stage studies.  While the freshwater fish study (rainbow trout, MRID 48400003) reached a definitive NOAEC, the study with an estuarine/marine species (sheepshead minnow, MRID 48400004) yielded a non-definitive endpoint, <39 ug a.i/L.  While estimation of RQs with this endpoint will not be entirely precise, it is still useful to quantify a lower bound estimate of risk since the RQs generated would be at least that value (i.e. a ">" value).  Because of this, there is a high degree of uncertainty where the actual RQ falls.  For example, an RQ of >0.18, while below the chronic LOC of 1 does have the potential to be in exceedance of the LOC and therefore an indicator for the potential of chronic effects.  For the proposed uses on fenpyrazamine, estimated freshwater fish chronic RQs ranged from 0.02  -  0.22.  The highest RQ is 5 times away from the  chronic LOC of 1.  For estuarine/marine fish, RQs were estimated using the NOAEC of 39 ug a.i/L for bounding purposes. The resultant RQs would be preceded with a ">" sign to distinguish these RQs because the actual NOAEC is known to be below 39 ug a.i/L.  Consequently, such unbounded RQs do not enable a conclusive determination of risk (or lack thereof) to be made.  With the proposed uses of fenpyrazamine, the unbounded RQ for the ornamental use does exceed the chronic LOC of 1, yet how far above this threshold the actual RQ falls is an uncertainty.  As mentioned previously, RQs derived from non-definitive endpoints are uncertain yet are still useful to quantify the potential effects in risk assessment. 
 
 Despite the unbounded estimates of risk and the indication that the chronic LOC of 1 may be exceeded, there are two reasons why chronic risk to estuarine/marine fish may be presumed to be low.  The first point relates to the fact the NOAEC for the chronic fish study was based on mean body length and the lowest treatment concentration of the study (39 ug a.i/L) resulted in a 4.3% reduction from the negative control.  This response is considered relatively modest in nature from a biological perspective.  Furthermore for this endpoint, the effects did not follow a dose response pattern with the next two higher concentrations (62 and 150 ug a.i/L) resulting in percent reductions from the control of 1.9 and 2.7% respectively. Additionally, the structure activity relationships tool, ECOSAR (v. 1.10) was employed to get a conservative estimation of chronic toxicity to estuarine/marine fish.  ECOSAR estimates toxicity to various taxa by way of breaking down toxicity estimates by ECOSAR-specific classes (See Appendix G for further information on ECOSAR and its estimates of toxicity for the various degradation products of fenpyrazamine.)  When the chemical structure is input into ECOSAR, the results of 4 ECOSAR classes are returned that includes aliphatic amines, hydrazines, amides, and thiocarbamates.  For the aliphatic amines and hydrazine classes, only chronic results for fish are specified (as opposed to estuarine/marine fish) and for the amide and thiocarbamates classes there are specific chronic toxicity estimates for estuarine/marine fish estimated.  The estimates of a chronic NOAEC for fish range from 0.2 to 19.6 mg/L, depending on the chemical class.  For fenpyrazamine, the highest 1-in-10 year 60 day average EEC was for the NJ ornamental use and was 80.35 ug/L or 0.08 mg/L.  As the most sensitive estimate of chronic toxicity for fish as determined by ECOSAR is one order of magnitude below the highest 60-day average EEC, the conservative estimates indicate risk below the chronic LOC.  Taken with the unbounded estimated chronic RQs from the registrant submitted data, chronic risk for fish is indicated for the ornamental use only but it remains an uncertainty of where the actual estimate of the chronic RQs fall.
 
 The second point relates to the likely conservative estimate of exposure for fenpyrazamine in the water column.  The lower bound aspect of the risk quotient is mitigated due to the fact that hydrolysis is conservatively not included as a degradation pathway due to significant uncertainties in the hydrolysis study (MRID No. 48399923).  The existing data on hydrolysis indicates that fenpyrazamine degrades to some extent, especially in alkaline environments.  However, the exact rate at which it degrades under neutral conditions is unknown due to the lack of data available at environmentally relevant conditions.  The exclusion of hydrolysis from water column under neutral conditions contributes to the overall steady EEC values of fenpyrazamine occurring over all averaging periods as shown in Table 12 and Table 13.  In addition, the aquatic exposure modeling utilized the very conservative default assumption for input parameterization of anaerobic aquatic metabolism as only one sediment  -  water system was available.  Therefore, the single anaerobic aquatic metabolism half life available for modeling was multiplied by three.  Given the evidence for fenpyrazamine degradation due to hydrolysis especially over alkaline environments and that fenpyrazamine may be less persistent than modeled over neutral environments, it is possible that chronic EECs would be lower.  Additionally, a new chronic ELS study that reaches a definitive NOAEC would address this uncertainty but refined EECs could negate the need for that data if it is indicated that exposure would be significantly reduced from present levels.   
 
                  * Aquatic Invertebrates (Water Column)
 
 Chronic toxicity studies are available for both freshwater and estuarine/marine invertebrates.  For freshwater invertebrates, chronic RQs ranged from 0.02  -  0.25.  The highest RQ is 4 times lower than the chronic LOC of 1.  For estuarine/marine invertebrates, RQs were estimated using the NOAEC of 98 ug a.i/L for bounding purposes.  The resultant RQs would therefore be preceded by a "<" sign to distinguish these RQs because the actual NOAEC is known to be above 98 ug a.i/L.  Consequently, such unbounded RQs do not enable a conclusive determination of risk (or lack thereof) to be made.  In the case of chronic risk to estuarine/marine invertebrates however, there were no exceedances of the chronic LOC of 1 with the estimated unbounded RQs.  As the actual bounded RQs are known to be below the estimated unbounded RQs, chronic risk to estuarine/marine invertebrates is expected to be low.
 
                  * Aquatic Invertebrates (Benthic)
 
 Chronic toxicity studies are available for freshwater and estuarine/marine benthic invertebrates. Studies with the freshwater invertebrates Hyalella azteca and Chironomus riparius were conducted for 42-d and 28-d exposures, respectively.  Additionally, a 28-day study with the estuarine/marine organism Leptocheirus plumulosus is available for risk estimation.  The 21-day 1-in-10 year EEC for pore water  is compared to the toxicity endpoint expressed in terms of pore water are compared to each other for pore water RQs and the same is done for 1-in-10-year sediment EECs and endpoints expressed in terms of sediment concentrations.  Both the most sensitive endpoints from the freshwater and estuarine/marine benthic invertebrate studies resulted in NOAECs that were non-definitive.  

For the most sensitive freshwater benthic invertebrate study (C. riparius, MRID 48400007), the sediment and pore water expressed endpoints were <101 ug a.i/kg sediment and <20 ug a.i/L.  The resultant RQs would be preceded with a ">" sign to distinguish these RQs because the actual NOAEC is known to be below 101 ug a.i/kg sediment and 20 ug a.i/L.  Similarly, the most sensitive endpoints for the estuarine/marine benthic invertebrate were <3000 ug a.i/kg sediment and <250 ug a.i/L.   The resultant RQs would be preceded with a ">" sign to distinguish these RQs because the actual NOAEC is known to be below 3000 ug a.i/kg sediment and 250 ug a.i/L.     Consequently, such unbounded RQs do not enable a conclusive determination of risk (or lack thereof) to be made.  It is noted however that the PRZM/EXAMS estimated pore water and sediment EECs do not significantly decline (rather in most cases, remain the same) from their peak values when extended out to 21-day and 60-day averages (Table 14, Table 15, Table 16, and Table 17).  This likely is the artifact of using the conservative default assumption for input parametrization of anaerobic aquatic metabolism since only one study is available.  With this uncertainty in mind, it is possible that sediment and pore water EECs would be lower than this assessment assumes but to what extent is also uncertain.  
 
 Currently, the highest sediment 1-in-10 year 21-day average EECs is 250 ug a.i/kg sediment (Table 16), which is approximately 2.5 fold higher than the most sensitive freshwater benthic organism endpoint (<101 ug a.i/kg sediment) and almost 12 fold lower than the most sensitive estuarine/marine benthic invertebrate endpoint (<3000 ug a.i/kg sediment). Similarly, the highest pore water 1-in-10 year 21-d average EEC is 46.8 ug a.i/L (Table 14) which is approximately 2 fold higher than the most sensitive freshwater benthic invertebrate endpoint (<20 ug a.i/L) and approximately 5 fold lower than the most sensitive estuarine/marine benthic invertebrate endpoint (<250 ug a.i/L).  This illustrates the assumption that sediment and pore water EECs which are calculated incorporating a robust sampling of water-sediment systems in an anaerobic environment may reduce the uncertainty of the non-definitive RQs by providing concentrations that are several fold or even orders of magnitude lower than the most sensitive sediment and pore water-expressed toxicity endpoints.  Additionally, further sediment toxicity studies that reach definitive endpoints would also reduce the uncertainty of non-definitive RQs.
 
 It should also be stated that as mentioned in Section 3, unextracted residues incorporated in soil or sediment layers are not included for benthic pore water or sediment EECs.  The reasons for not including unextracted residues include the following rationale:  1.) It was sufficiently demonstrated that bound residues do not desorb into the water column based on aerobic aquatic and aerobic soil metabolism laboratory studies, where exhaustive methods of extraction were used (MRID Nos. 48399920, 48399927, and 48399929), 2.)  Unextracted residues comprised of a negligible amount of the material balance based on the anaerobic aquatic metabolism lab study (MRID No. 48399930), and 3.)  Inclusion of unextracted residues on eroded soil particles input into the sediment layer had no effect on the pore water EECs since input parameter half-lives with and without the residues were similar.  Therefore, uncertainties related to the identity of unextracted residues should have no impact on this risk assessment.
 
                  * Aquatic Plants
 
Aquatic plant toxicity data are available for one species of vascular plant and four species of non-vascular algal organisms.  For both vascular and non-vascular aquatic plants, the non-listed species RQ is derived by a comparison of the peak EEC to the EC50 of the toxicity study while the listed species RQ is derived by a comparison of the peak EEC to the NOAEC of the study.  The LOC for both measures is 1.  For non-vascular aquatic plants, the non-listed LOC was exceeded for all proposed uses of fenpyrazamine except almonds and pistachios with the RQs ranging from 1.30  -  7.87 indicating the potential for toxic effects to this taxa.  For listed aquatic vascular plants, the LOC was exceeded for every proposed use of fenpyrazamine with RQs ranging from 1.51  -  17.67, indicating the potential for toxic effects to this taxa.  Vascular aquatic plants were substantially less sensitive and there were no listed or non-listed LOC exceedances for all proposed uses of fenpyrazamine.  Conservative EECs resulting from excluding hydrolysis as a degradation pathway given fenpyrazamine's uncertainties of hydrolysis under environmentally relevant conditions are also applicable for aquatic plants in this case particularly due to its impact between applications.  As a result, peak EECs may be substantially lower when considering hydrolysis as a viable degradation pathway. .

 Additional non-vascular aquatic plant toxicity studies were submitted for two degradation products of fenpyrazamine.  Studies conducted on the freshwater green algae (Pseudokirchneriella subcapita) using the degradates S-2188-DC and S-2188-OH (MRIDs 48400019 and 48400020, respectively). Both studies determined that the degradates that were tested were  approximately 150 times less toxic to freshwater green algae than parent fenpyrazamine by 3 orders of magnitude for-2188-DC and S-2188-OH (based on EC50 values). As the NOAEC value was non-definitive for parent fenpyrazamine freshwater green algae study, the EC05 of 0.029 mg a.i/L was used which is approximately 55 times more sensitive than the most sensitive NOAEC from both degradation product studies (1.6 mg a.i/L).  Given the varying sensitivities of freshwater green algae to parent fenpyrazamine and two of its degradates, the estimated listed and non-listed RQs would be significantly less for these degradation products than those estimated for parent fenpyrazamine.  Biodegradation and abiotic degradation of fenpyrazamine in the water column and availability of degradate products to runoff as described above for fish species also suggest that exposure of degradate residues will not cause adverse impacts to aquatic plants.
 		
Risks to Terrestrial Animals  
 		
                     a. Potential for Acutely Toxic Exposures 

                  * Birds 
 
 The analysis conducted in risk estimation determined there to be acute dose-based risk to small and medium sized birds depending on the food item and crop use of fenpyrazamine.  RQs ranged from <0.0004  -  <0.53, which marginally exceeds the acute non-listed species LOC of 0.5.   These RQ values are based on the most sensitive LD50 value available (> 2,000 mg a.i./kg bw for the canary and northern bobwhite quail (Table 26).  Acute dietary-based RQs ranged from <0.05  -  <0.15 with the high end of the range marginally exceeding the endangered species LOC of 0.1 (ornamental use, Table 27).  These RQs values are also based on the most sensitive LD50 -  value available, which is also a non-definitive endpoint (LC50 >4430 ppm).  Only upper bound (non-definitive) RQs could be determined because no treatment related mortality occurred at the highest dose tested in the available toxicity studies (i.e., non-definitive LD50/LC50 values).  A review of the acute oral studies for sub lethal effects also indicates no treatment-related effects on endpoints such as food consumption, body weight and behavior.  A review of the subacute dietary studies shows a significant reduction (p<0.05) in mean body weight gain as compared to the negative control in the three highest treatment concentrations for the bobwhite study and the highest treatment concentration for the mallard study.  Despite the uncertainty in non-definitive endpoints, these estimates are still useful in risk assessment as they give an indication of where potential acute risk to birds may be a concern
 
                  * Mammals
 
 Similar to birds, acute dose-based risks to mammals are considered low as indicated by acute RQs of <0.0003 to <0.15 (Table 28).  These RQ values are based the most sensitive acute toxicity endpoint available (>2000 mg a.i/kg bw for the rat (Table 9).  Only upper bound (non-definitive) RQs could be determined because no treatment related mortality occurred at the highest dose tested in the available toxicity studies (i.e., non-definitive LD50 values).  A review of the acute oral studies for sub lethal effects also indicates no treatment-related effects on endpoints such as food consumption, body weight and behavior.  
 
                     a. Potential for Chronically Toxic Exposures
 
                  * Birds 
 
 Chronic dietary-based RQs for birds (0.06 - 2.72; Table 27) indicate chronically toxic exposure to fenpyrazamine with all proposed uses except almonds and pistachios (for which the chronic RQ on short grass approaches the LOC at 0.94).  Chronic dietary-based risk exceeds the LOC for birds ingesting short and tall grass as well as broadleaf plants exposed to fenpyrazamine resulting from the ornamental use, and from ingesting only short grass for all other uses (except almonds and pistachios).  These chronic RQs are based on a dietary NOAEL of 248 ppm for the northern bobwhite quail (MRID 48400014) based on effects to hatching body weight (day 14) which occurred at the LOAEL of 495 ppm in the diet.  It is noted that while significant effects (p<0.05) to hatching weight at day 14 occurred at the two highest treatment concentrations (495 and 978 ppm), the percent reduction from the negative control was 6.2 and 4.9%, respectively which is considered modest in terms of a biological effect.  
 
                  * Mammals 
 
 Chronic dose-based risks associated with mammalian consumption of fenpyrazamine exposed food items are indicated in this assessment, with chronic RQs ranging from 0.01 to 3.66 (Table 29).  Chronic risks are identified for all size classes of mammals considered (15, 35 and 1000g)  for the proposed use on ornamentals only and for the small and medium sized class mammals for all other uses (for mammals eating short grass).  Small and medium sized mammals ingesting fenpyrazamine exposed broadleaf plants are in exceedance of the LOC for the strawberries, ginseng, and ornamental use and tall grass for the ornamental use only.    These RQ values are based on a NOAEL of 1000 ppm in the diet (73.7 mg a.i/kg bw) identified for the Norway rat (MRID 48400127).  The LOAEL from this study was 3000 ppm in the diet based on reduced number of implantation sites.  Significant (p<0.05) effects also included increased post natal loss and body weight reduction in the highest treatment level (3000 ppm).  
 
                  * Non-target beneficial insects and other non-target terrestrial organisms 
 
 The potential exposure of honeybees to pesticides is assessed qualitatively based on laboratory data and if available, field data.  There is a small potential for exposure via transport within the plant to pollen and nectar.  It is noted that fenpyrazamine is classified as practically non-toxic to honeybee (acute contact LD50 >100 ug a.i/bee and an acute oral LC50 of >100 a.i/bee).  Clinical sings of toxicity included bees showing lethargic symptoms at varying numbers that increased with concentration in the acute contact toxicity study.  While conceptually potential routes of exposure exist for fenpyrazamine to honeybees and other insect pollinators, the very low toxicity of fenpyrazamine to honeybees suggest that this route of exposure is not likely to be a concern.	
 
 An acute toxicity study was also submitted for the earthworm which showed no significant effects on mortality.  Sublethal effects included effects on body weight which was reduced at all but the highest treatment concentration and lethargy observed in earthworms in the highest treatment concentration.


Risks to Terrestrial Plants  
 
Seedling emergence and vegetative vigor studies are available to estimate RQs for listed and non-listed terrestrial plants.  The results of TerrPlant indicate an exceedance of the LOC of 1 for listed dicot species in semi-aquatic plants, and listed monocots in semi-aquatic as well as listed dicots in dry areas and those resulting from spray drift for the ornamental use only.  RQs for both listed and non-listed plants were derived from the use of non-definitive endpoints.  For non-listed plants, for which the EEC is compared to the EC25 value, both the seedling emergence and vegetative vigor studies had a determined EC25 value of >0.53 lbs a.i/A due to a lack of effects.  The NOAEC for the vegetative vigor study was also the highest treatment concentration (0.53 lbs a.i/A).  For the seedling emergence study, the NOAEC could not be definitively determined for the most sensitive dicot based on effects at the lowest treatment concentration on biomass (dry weight, NOAEC of <0.035 lbs a.i/A).   In the event a NOAEC being non-definitive, EFED policy is to use the EC05 for that endpoint.  In this case however,  although the statistical regression model was able to converge, the model  determined the  EC05 to be 0.0.  As a result, the value of 0.035 was used to estimate RQs for listed dicot in the TerrPlant model with the RQs being preceded by a ">" sign to signify the RQs may lie higher than this estimated value but to what extent is uncertain.	
	
Review of Incident Data  
 
 As fenpyrazamine has not been previously approved for use in the United States, there are no incident reports for this chemical.
	
Threatened and Endangered Species Concerns 
 
For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by the Federal action and not merely the immediate area involved in the action.  At the initial screening-level, the risk assessment considers broadly described taxonomic groups and so conservatively assumes that list species within those broad groups are collocated within 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.  The assessment also assumes that the listed species are located within an assumed area which has the relatively highest potential exposure to the pesticide, and that exposures are likely to decrease with distance from the treated area.  

If the assumptions associated with the screening-level action area result in RQs that are below the listed species LOCs, "no effect," determination conclusion may be made with respect to listed species in that taxa (for direct effects), and no further refinement of the action is necessary.  Furthermore, RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects upon listed species that depend upon the taxonomic group as a resource.  However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential "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 on that taxonomic group as a resource.  In such cases, additional information on the biology of the listed species, the locations of these species, and the locations of use sites could be considered along with available information on the fate and transport properties of the pesticide to determine the extent to which screening assumptions regarding an action area apply to a particular listed organism.  These subsequent refinement steps could consider how this information would impact the action area for a particular listed organism and may potentially include areas of exposure that are downwind and downstream of the pesticide use site. 

In conducting a screen for indirect effects, direct effects LOCs for each taxonomic group are used to make inferences concerning the potential for indirect effects upon listed species that rely upon non-listed organisms in these taxonomic groups as resources critical to their cycle.  Pesticide use scenarios resulting in RQs that are below all direct effect listed species LOCs for all taxonomic groups assessed are considered of no concern for risks to listed species either by direct or indirect effects.

For fenpyrazamine, the potential direct effects to listed species should they co-occur with application sites are indicated for mammals (acute and chronic toxicity) and birds (acute and chronic toxicity) based on ingestion of fenpyrazamine contaminated food items.  Listed species LOCs are exceeded for any other taxonomic group assessed (aquatic animals, aquatic plants, nontarget invertebrates).  For the maximum proposed fenpyrazamine application rates, there may be a potential concern for direct effects to the following groups of organisms:
 
 Birds  
 Mammals
 Terrestrial-phase reptiles
 Terrestrial-phase amphibians

A spatial co-occurrence analysis would be necessary to delineate the action area. 

            6.3.6 Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps  
 
 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 does not provide information on the potential variability in susceptibility to acute and chronic exposures. 
 
                     a. Incidental Pesticide Releases Associated with Use 
 
 This risk assessment is based on the assumption that the entire treatment area is subject to fenpyrazamine application at the rates specified on the label.  In reality, there is the potential for uneven application of fenpyrazamine through such plausible incidents as changes in calibration of application equipment, spillage, and localized releases at specific areas of the treated field that are associated with specifics of the type of application equipment.
 
                     b. Exposure for Aquatic Species 
 
 This Tier II risk assessment relies on best available estimates of environmental fate and physicochemical properties, maximum application rate of fenpyrazamine, maximum number of applications, and the shortest interval between applications.  However, several modeling limitations are noted and should be considered in interpreting the results of this aquatic risk assessment.  
  
 ::	The frequency at which actual fenpyrazamine uses approach the use estimates modeled is dependent on resistance to the fungicide, timing of applications, and market forces. In general, model output values represent the upper bound estimates of concentrations that might be observed in surface water due to the application of fenpyrazamine, given available data and model limitations.	
 
 ::	Although there are uncertainties associated with using the standard PRZM/EXAMS runoff scenario (10 ha field draining into 20,000 m[3] pond with no outlet) for an aquatic exposure assessment, it is designed to represent pesticide exposure from an agricultural watershed impacting a vulnerable aquatic environment.  Extrapolating the risk conclusions from this standard pond scenario to a specific body of water of different dimensions, may either underestimate or overestimate the potential risks.
 
 ::	Major uncertainties associated with the standard runoff scenario include the physical construct of the watershed and representation of vulnerable aquatic environments for different geographic regions.  The physicochemical properties (pH, redox conditions, etc.) of the standard farm pond are based on a Georgia farm pond.  These properties are likely to be regionally specific because of local hydrogeological conditions.  Any alteration in water quality parameters may impact the environmental behavior of a pesticide.  The farm pond represents a well mixed, static water body.  Because the farm pond is a static water body (no flow through), it does not account for pesticide removal through flow through or water releases.  The lack of flow through the farm pond provides an environmental condition for accumulation of persistent pesticides.  The assumption of uniform mixing does not account for stratification due to thermoclines (e.g., seasonal stratification in deep water bodies).  Additionally, the dimensions of the standard runoff scenario assume a watershed area to water body volume ratio of 10 ha: 20,000m[3].  This ratio is recommended to maintain a sustainable constructed pond in the Southeastern United States.  The use of higher watershed area to water body volume ratios (as recommended for sustainable ponds in drier regions of the United States) may lead to higher pesticide concentrations when compared to the standard watershed area to water body volume ratio.
 
 ::	The standard runoff scenario assumes uniform soils and agronomic management practices across the standard 10 hectare field.  Soils can vary substantially across even small areas; this variation is not reflected in the model simulations.  Additionally, the impact of unique soil characteristics and soil management practices (e.g., tile drainage) are not considered in the standard runoff scenario.  The assumption of uniform site and management conditions is not expected to represent some site-specific conditions.  Extrapolating the risk conclusions from the standard pond scenario to other aquatic habitats (e.g., marshes, streams, creeks, and shallow rivers, intermittent aquatic areas) may either underestimate or overestimate the potential risks in those habitats.
 	
 ::	Aquatic EECs are based on a conservative scenario the entire watershed area is impacted by a treated crop.  However, in reality, only a percentage of the watershed is impacted by a crop treatment.
 						
 ::	For an acute risk assessment, there is no averaging time for exposure.  A peak concentration, with a 1 in 10 year return frequency, is assumed.  The use of the peak concentration in the calculation of risk quotients assumes that exposure is sufficient to elicit acute effects comparable to those observed over more protracted exposure periods tested in the laboratory, typically 48 to 96 hours.  In the absence of data regarding time-to-toxic event analyses and latent responses to peak exposure, the degree to which risk is overestimated cannot be quantified.
 
There are also several significant uncertainties with the environmental fate profile of fenpyrazamine. These uncertainties can impact estimation of acute and chronic EECs in surface water, benthic pore water, as well as sediment.

The first major uncertainty concerns fenpyrazamine's rate of hydrolysis in the environment.  The existing hydrolysis study suggests that fenpyrazamine degrades over all environments, especially in alkaline environments, with metabolites S-2188-OH and S-2188-DC detected (MRID No. 48399923).  This is also evident from the aerobic aquatic metabolism study (MRID No. 48399929), which also shows a trend of decreased half-lives at higher pHs.  However, environmentally relevant hydrolysis data were not provided to the Agency for neutral environments (pH7).  .  In the absence of adequate data, EFED conservatively assumed that the chemical persists to hydrolysis at pH 7.  This uncertainty could be addressed by a guideline hydrolysis study conducted at environmentally relevant temperatures.  The study may be used to recalculate aquatic EECs more representative of fenpyrazamine levels in the environment.  Additional data can especially impact future new uses with high application rates resulting in higher risk quotients.  However, no additional data will be requested at this time.

 A second significant uncertainty relates to the limited systems evaluated in the anaerobic aquatic study  (MRID Nos. 48399930).  Only one system was evaluated in each study.  Additional studies could provide a more robust representation for the degradation of fenpyrazamine in suboxic environments.  Therefore, more refined aquatic EECs, especially related to benthic organisms, may result considering that the single half-life values were multiplied by three as a conservative default to address this uncertainty.  However, no additional data will be requested at this time.

 A third uncertainty regards unextracted residues incorporated in soil or sediment layers.  In soil, unextracted residues accounted for approximately up to 70 percent of applied in two alkaline soils in aerobic soil metabolism studies (MRID No. 48399920).  In water, unextracted residues in sediment from the Calwich Abbey, UK study sample accounted for up to 48.4 percent of applied.  Despite these large levels of unextracted residues detected in aerobic soil and aerobic aquatic metabolism, unextracted residues were excluded from the expression of the "total residues of concern" and, therefore, from the aquatic EECs.   First, it was sufficiently demonstrated that bound residues do not desorb into the water column based on aerobic aquatic and aerobic soil metabolism laboratory studies, in which exhaustive methods of extraction were used (MRID Nos. 48399920, 48399927, and 48399929).  Second, unextracted residues comprised of a negligible amount of the material balance based on the anaerobic aquatic metabolism lab study (MRID No. 48399930).  Third, inclusion of unextracted residues incorporated in eroded soil input into the sediment layer had no effect on the pore water EECs since the aerobic soil metabolism half life parameterization without the unextracted residues was generally similar.  Therefore, uncertainties related to the identity of unextracted residues should have no impact on EECs or the risk conclusions in this risk assessment.  However, it should be noted that unextracted residues are likely bonded chemically to the humin matrices within the soil and sediment layers.  Soil-water partition coefficients of fenpyrazamine and degradates as well as inconsistencies in the amount of unextracted residues between the aerobic and anaerobic aquatic metabolism studies suggest that unextracted residues are not forming due to sorbtion of fenpyrazamine.
 
 
 A fourth uncertainty which exists is that water-sediment systems with variable pHs were evaluated in the aerobic aquatic metabolism study (MRID No. 48399929).  Since degradation is much different between acidic and alkaline conditions, it appears that degradation is mediated pH.  Additional soil-sediment systems evaluated over a similar pH range would provide insight on the effect of degradation solely on microbial activity.
 
 The fifth uncertainty concerns the lacking information on the representativeness on foreign soils evaluated in aerobic soil metabolism and batch equilibrium studies to domestic soils.  Regardless of these deficiencies, the studies conducted  on soils in the United Kingdom in batch equilibrium and aerobic soil metabolism studies (MRID Nos. 48399919 and 48399920, respectively) were considered since soils from the UK are traditionally similar in their physical chemical characteristics to soils that exist within the United States.
 
                     b. Exposure for Terrestrial Species 
 
 This risk assessment relies on the best available estimates of environmental fate and physicochemical properties, maximum application rate of fenpyrazamine, 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.  
 
                  * Dietary Exposure
 
 For screening terrestrial risk assessments, a generic bird or mammal is assumed to consume 100% of its diet on food which is contaminated with fenpyrazamine from the application site.  This assumption may lead to an overestimation of exposure to species that do not occupy the treated field. The actual habitat requirements of any particular terrestrial species are not considered, and it is assumed that species occupy, exclusively and permanently, the treated area being modeled.  This assumption leads to a maximum level of exposure in the risk assessment.  
 
                  * Dermal Exposure
 
 The screening assessment does not consider fenpyrazamine 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.
 
                  * Inhalation Exposure
 
 Preliminary results of the screening level tool STIR (described earlier in this assessment) indicate that inhalation exposure alone is not expected to be a significant route of exposure for fenpyrazamine to wildlife.  The input and output file can be found in Appendix B.
 
                  * Drinking Water Exposure 
 
 Preliminary results of the screening level tool SIP (described earlier in this assessment) indicate that drinking water exposure alone is not expected to be a significant route of exposure for fenpyrazamine to wildlife.  The input and output file can be found in Appendix C.
 
 
                     b. Effects Assessment 
 

As the data available to support the terrestrial and aquatic effects assessment for fenpyrazamine is largely complete, the primary uncertainty with the available data is the presence of non-definitive endpoints for several taxa.  Non-definitive endpoints were reached for acute oral and dietary studies for birds, acute oral data for rats, acute toxicity studies for honey bees, acute and chronic studies for estuarine/marine fish, chronic freshwater and estuarine/marine sediment toxicity studies, and terrestrial plant studies.  However the non-definitive endpoints were "<," values (which would yield a ">" RQ) only for chronic estuarine/marine fish, freshwater and estuarine/marine sediment toxicity studies, and the terrestrial plant study for seedling emergence.  In these cases, it is uncertain where the actual RQ falls as the estimates are unbounded, or rather bounded on only one end.  As a result, estimates of chronic toxicity to estuarine/marine fish and sediment toxicity studies are in exceedances of the chronic LOC for some uses, but even those uses that are not in exceedance, it is an uncertainty where the actual RQ would fall.  Despite this uncertainty, the estimated chronic RQs could be refined with a suitable hydrolysis study as the assumptions that are made in its absence lead to conservative estimates of 1-in-10 year 60 day averages that are used to estimate chronic LOCs.  This is detailed further in Section 7.2.6.b.  

                  * 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.
 
                  * 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 fenpyrazamine than the surrogates, risks may be under- or overestimated, respectively. 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 fenpyrazamine and fish are an appropriate surrogate for aquatic-phase amphibians.   	
 	
                  * 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. 	
                         
                     5. IDENTIFICATION OF DATA GAPS

Environmental Fate and Exposure

Despite numerous uncertainties, the Agency is not asking for any additional studies at this time.  Please refer to Section 7.2.6b for further details.

Ecological Effects

The ecological toxicity database is essentially complete.  However the ELS study for sheepshead minnow and the sediment toxicity studies for Chironomus riparius and Leptocheirus plumulosus yielded non-definitive endpoints which raises uncertainty in the estimation of RQs to these organisms.  The need for new studies may be waived if uncertainties in the hydrolysis and soil metabolism studies can be worked out as lower estimates of aquatic exposure may result.  However, the Agency is not asking for any additional studies at this time.

                     6. REFERENCES

                        * Environmental Fate Studies 

MRID
Author(s)
Year
Title 
Hydrolysis
48399923
Lewis, C.
2007
[Carbon 14]S-2188: Hydrolytic Stability. Project Number: 200700497, 0333/257, QNM/0017. Unpublished study prepared by Covance Laboratories, Ltd. 184 p.
Aqueous Photolysis
48399924
Lewis, C.; Troth, K.
2007
[Carbon 14]S-2188: Photodegradation and Quantum Yield in Sterile, Aqueous Solution. Project Number: 200800010, 0333/258, QNM/0029. Unpublished study prepared by Covance Laboratories, Ltd. 195 p.
Air Photolysis
48399925
Liney, P.; Jarvis, T.
2009
S-1288 - Stability in Air. Project Number: 200900604, SU25005, QNM/0032. Unpublished study prepared by Exponent International, Ltd. 7 p.
Soil Photolysis
48399926
Lewis, C.; Troth, K.
2007
[Carbon 14]S-2188: Photodegradation on a Soil Surface. Project Number: 200700495, 0333/259, QNM/0020. Unpublished study prepared by Covance Laboratories, Ltd. 115 p.
Batch Equilibrium
48399919
Lewis, C.; Scholey, A.
2006
[Carbon 14]S-2188: Adsorption/Desorption in Soil. Project Number: 200600614, 0333/255, QNM/0012. Unpublished study prepared by Covance Laboratories, Ltd. 71 p.
48399922
Gohre, K.
2008
S-2188: Soil Adsorption/Desorption. Project Number: 200800201, VP/29272. Unpublished study prepared by Valent Dublin Laboratory. 90 p.
Aerobic Soil Metabolism
48399920
Lewis, C.; Troth, K.
2006
S-2188:  Aerobic Soil Metabolism and Degradation. Project Number: 200700498, 0333/256, QNM/0016. Unpublished study prepared by Covance Laboratories, Ltd. 127 p.
48399927
Gohre, K.
2008
S-2188:  Degradation Under Aerobic Conditions in Soil. Project Number: VP/29719, 200800286. Unpublished study prepared by Valent Dublin Laboratory. 169 p.
Aerobic Aquatic Metabolism
48399929
Lewis, C.; Troth, K.
2007
[Carbon 14] S-2188: Degradation and Retention in Water-Sediment Systems. Project Number: 200800017, 0333/260, QNM/0028. Unpublished study prepared by Covance Laboratories, Ltd. 188 p.





Anaerobic Aquatic Metabolism
48399930
Gohre, K.
2008
S-2188: Degradation Under Anaerobic Aquatic Conditions. Project Number: 200800200, VP/30465. Unpublished study prepared by Valent Dublin Laboratory. 152 p.
Fish BCF



48400005
Panthani, A.; Herczog, K.
2007
Bioconcentration of [Carbon 14] S-2188 by Bluegill Sunfish (Lepomis macrochirus). Project Number: 200700494, 019492/1, QNM/0018. Unpublished study prepared by Ricerca Biosciences, LLC. 241 p.
Terrestrial Field Dissipation
48399931
Kowalsky, J.
2010
Terrestrial Field Soil Dissipation of S-2188 on Bare Ground in California (2006). Project Number: 201000303, 30311. Unpublished study prepared by Valent Dublin Laboratory. 251 p.
48399932
Green, C.
2010
Terrestrial Field Soil Dissipation of S/2188 on Bare Ground in California (2009). Project Number: 33068. Unpublished study prepared by Valent Dublin Laboratory. 196 p.
48399933
Kowolsky, J.
2010
Terrestrial Field Soil Dissipation of S-2188 on Bare Ground in Idaho. Project Number: 201000313, 30309. Unpublished study prepared by Valent Dublin Laboratory. 264 p.
48399934
Kowolsky, J.
2010
Terrestrial Field Soil Dissipation of S-2188 on Bare Ground in New York. Project Number: 201000302, 30296. Unpublished study prepared by Valent Dublin Laboratory. 266 p.
Storage Stability
48399921
Peatman, M. 
2008
S-2188: Storage Stability of Residues in EU Soil Stored Deep Frozen. Project Number: 200900605, 0333/268, QNM/0036. Unpublished study prepared by Covance Laboratories, Ltd. 35 p.
Environmental Chemistry Method in Water
48399918
Bacher, R.
2008
S-2188: Analytical Method for the Determination in Water. Project Number: 200900211, P/1401/G, QNA/0015. Unpublished study prepared by PTRL Europe Gmbh. 36 p.
Independent Laboratory Validation for Water ECM
48400034
Dix, M.
2006
S-2188 - Validation of the Analytical Method for the Determination of a Test Substance in Aqueous Solutions. Project Number: 200600063, 13048/6503, ELECTRONIC/COPY. Unpublished study prepared by Springborn Smithers Laboratories. 39 p.
Environmental Chemistry Method in Soil/ Independent Laboratory Validation for Soil ECM
48400026
Green, C.
2010
Independent Laboratory Validation of Method RM-45S, Determination of S-2188 and S-2188-DC in Soil. Project Number: 201000244, 33001. Unpublished study prepared by Valent U.S.A. Corporation. 90 p.
                        * Ecological Effects Studies
      
MRID
Author(s)
Year
Title 
48399935
Hoberg, J.R.
2006
S-2188 Technical Grade- Acute Oral Toxicity Test with the Honey Bee (Apis mellifera).  Springborn Smithers Laboratories, 790 Main Street Wareham, Massachusetts 02571-1037.  Sumitomo Chemical Company, Ltd. Laboratory Report ID: 13048.6510. 39 p.
48399936
Hara, T.
2008
Acute Immobilization Test of MCNI with Daphnia magna. Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EFA. Study sponsored by Sumitomo Chemical Corporation. Study completed March 20, 2008. 29 p.
48399937
Hara, T.
2008
Acute Immobilization Test of S-2188-OH with Daphnia magna. Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EDI. Study sponsored by Sumitomo Chemical Corporation. Study completed March 20, 2008. 27 p. 
48399938
Hara, T.
2008
Acute Immobilization Test of S-2188-DC with Daphnia magna. Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0706EDI. Study sponsored by Sumitomo Chemical Corporation. Study completed March 20, 2008.  32 p. 
48399939
Putt, AE
2006
S-2188 Technical Grade- Acute Toxicity to Water Fleas (Daphnia magna) Under Flow-Through Conditions. Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA. Laboratory report number 13048.6507. Study sponsored by Sumitomo Chemical Corporation. Study completed June 23, 2006.  91 p.
48399940
York, DO
2010
V-10135 T.G. (S-2188 T.G.): Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under Flow-Through Conditions.  Smithers Viscient Laboratories 790 Main Street, Wareham, Massachusetts 02571-1037.  Laboratory Report ID: 12709.6302.  81 p.
48399941
Fournier, A.E
2010
V-10135 T.G. (S-2188 T.G.): Acute Toxicity to Mysid (Americamysis bahia) Under Static Conditions, Following OPPTS Guideline 850.1035.  Smithers Viscient Laboratories, 790 Main Street, Wareham, MA 02571-1037.  Laboratory Report ID: 12709.6303.  82 p.
48399942
Ashida, S.
2008
Acute Toxicity Test of S-2188-DC With Rainbow Trout (Oncorhynchus mykiss). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0706EFA. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed March 20, 2008.  27 p.
48399943
Ashida, S.
2008
Acute Toxicity Test of S-2188-OH With Rainbow Trout (Oncorhynchus mykiss). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EFA. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed March 20, 2008.  27 p.
48399944
Cafarella, MA.
2006
S-2188 Technical Grade- Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) Under Flow-Through Conditions. Unpublished study performed by Springborn Smithers Laboratories, 790 Main Street, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6505. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed April 14, 2006. 89 p.
48399945
Cafarella, MA.
2006
S-2188 Technical Grade- Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions. Unpublished study performed by Springborn Smithers Laboratories, 790 Main Street, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6504. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed March 30, 2006.  88 p.
48399946
Fournier, AE.
2010
V-10135 T.G, (S-2188 T.G.) Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions. Unpublished study performed by Smithers Viscient Laboratories (formerly Springborn Smithers Laboratories), Wareham, Massachusetts. Laboratory report number 12079.6301. Study sponsored by Valent U.S.A. Corporation. Study completed November 18, 2010.  77 p.
48400001
Putt, AE.
2006
S-2188 Technical Grade  -  Full Life-Cycle Toxicity Test with Water Fleas, Daphnia Magna under Flow-Through Conditions.  Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA.  Laboratory Study No. 13048.6508.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation, Walnut Creek, CA.  Study initiated February 17, 2006 and completed September 27, 2006.  112 p.
48400002
Lee, M.R
2010
V-10135 T.G. (S-2188 T.G.)  -  Life-Cycle Toxicity Test with Mysids (Americamysis bahia) Following Draft OPPTS Guideline 850.1350.  Springborn Viscient Laboratories, 790 Main Street, Wareham, MA  02571-1037.  Laboratory Report ID: 13845.6109.  150 p.
48400003
Cafarella, M.A
2006
S-2188 Technical Grade  -  Early Life-Stage Toxicity Test with Rainbow Trout (Oncorhynchus mykiss).  Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA.  Laboratory Study No. 13048.6506.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation, Walnut Creek, CA.  Study initiated January 23, 2006 and completed September 19, 2006. 111 p.        
48400004
Lee, M.R
2010
V-10135 T.G. (S-2188 T.G.) Early Life-Stage Toxicity Test with Sheepshead Minnow (Cyprinodon variegatus).  Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA.  Laboratory Study No. 12709.6292.  Study sponsored by Valent U.S.A. Corporation, Walnut Creek, CA.  Study initiated December 9, 2009 and completed October 8, 2010.  87 p.
48400006
Picard, C.R
2010
42-Day Toxicity Test Exposing Freshwater Amphipods (Hyalella azteca) to V-10135 (S-218) Applied to Sediment Under Static-Renewal Conditions Following EPA Test Methods. Springborn Smithers Laboratories, 790 Main Street, Wareham, MA  02571-1037.  Valent USA Corporation, 1600 Riveria Avenue, Suite 200, Walnut Creek, CA  94596-8025.  Laboratory Report ID: 12709-6290.  193 p.
48400007
Putt, A.E
2009
S-2188 Technical Grade  -  Full Life-Cycle Toxicity Test with Sediment-Dwelling Midges (Chironomus riparius) Under Static Conditions, Following OECD Guideline 219.  Springborn Smithers Laboratories, 790 Main Street, Wareham, MA  02571-1037.  Valent U.S.A. Corporation 1600 Riveria Avenue, Suite 200 Walnut Creek, CA.    Laboratory Report ID: 13048.6535.  106 p.
48400008
Picard, C.R
2010
V-10135 (S-2188)  -  28-Day Toxicity Test Exposing Estuarine Amphipods (Leptocheirus plumulosus) to a Test Substance Applied to Sediment Following EPA Test Methods.  Springborn Smithers Laboratories 790 Main Street Wareham, MA  02571-1037.  Valent U.S.A. Corporation 1600 Riveria Avenue, Suite 200 Walnut Creek, CA.  Laboratory Report ID: 12709.6291.  121 p.  
48400009
Stafford, J.M
2006
-2188 Technical Grade- Acute Oral Toxicity Test (LD50) with Northern Bobwhite Quail (Colinus virginianus).  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina.  Laboratory Report No. 13048.4104.  Study sponsored by Sumitomo Chemical Company, Ltd, Tokyo, Japan and submitted by Valent USA Corporation.  Study initiated December 30, 2005 and completed April 11, 2006. 50 p.
48400010
Hubbard, P.M
2010
V-10135: An Acute Oral Toxicity Study with the Canary (Serinus canaria).  Unpublished study performed by Wildlife International, Ltd, Easton, Maryland.  Laboratory Project No. 263-165.  Study submitted by Valent USA Corporation.  Study initiated June 29, 2010 and completed September 9, 2010.  46. 
48400011
Stafford, J.M
2006
S-2188 Technical Grade- Dietary Toxicity Test with Northern Bobwhite Quail (Colinus virginianus).  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina and Wareham, Massachusetts.  Laboratory Project ID 13048.4105.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date April 1, 2006; completion date July 3, 2006.  102 p.  
48400012
Stafford, J.M
2006
S-2188 Technical Grade- Dietary Toxicity Test with the Mallard Duck (Anas platyrhynchos).  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina and Wareham, Massachusetts.  Laboratory Project ID 13048.4106.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date June 12, 2006; completion date September 28, 2006.  99 p.
48400013
Stafford, J.M
2008
S-2188 Technical Grade- Reproductive Toxicity Test with Mallard Ducks (Anas platyrhynchos) Following OPPTS 850.2300 and OECD 206.  Unpublished study performed by Springborn Smithers Laboratories, Wareham, Massachusetts.  Laboratory Project ID 13048.4108.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date May 29, 2007; completion date April 25, 2008.  179 p. 
48400014
Stafford, J.M
2008
S-2188 Technical Grade- Reproductive Toxicity Test with Northern Bobwhite (Colinus virginianus) Following OPPTS 850.2300 and OECD 206.  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina and Wareham, Massachusetts.  Laboratory Project ID 13048.4107.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date January 19, 2007; completion date April 25, 2008.  177 p.
48400015
Hoberg, J.R
2006
S-2188 Technical Grade- Acute Contact Toxicity Test with the Honey Bee (Apis mellifera).  Springborn Smithers Laboratory 790 Main Street Wareham, Massachusetts 02571-1037.  40 p.
48400016
Porch, J.R
2010
V-10135: A Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of Plants.  Unpublished study performed by Wildlife International, Ltd., Easton, Maryland.  Laboratory Project Number: 263-166.  Study sponsored by Valent U.S.A. Corporation.  Study completed September 15, 2010.  147 p. 
48400017
Porch, J.R
2010
A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants.  Unpublished study performed by Wildlife International, Ltd., Easton, Maryland.  Laboratory Project Number: 263-167.  Study sponsored by Valent U.S.A. Corporation.  Study completed December 14, 2010.  167 p.
48400018
Softcheck, K.A
2010
7-Day Toxicity Test with Duckweed (Lemna gibba) Following OPPTS Draft Guideline 850.4400. Unpublished study performed by Smithers Viscient Laboratories, 790 Main Street, Wareham, Massachusetts 02571-1037. Laboratory report number 12709.6305. Study sponsored by Valent U.S.A. Corporation. Study completed November 8, 2010.  110 p. 
48400019
Matsuura, Y.
2008
Growth Inhibition Test of S-2188-DC with the Freshwater Green Alga (Pseudokirchneriella subcapitata). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chrome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0706EAI. Study sponsored by Valent U.S.A. Corporation. Study completed March 19, 2008.  37 p.
48400020
Matsuura, Y.
2008
Growth Inhibition Test of S-2188-OH with the Freshwater Green Alga (Pseudokirchneriella subcapitata). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chrome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EAI. Study sponsored by Valent U.S.A. Corporation. Study completed March 19, 2008.  37 p.
48400021
Hoberg, J.R
2008
Growth Inhibition Test of S-2188-DC with the Freshwater Green Alga (Pseudokirchneriella subcapitata). Unpublished study performed by Springborn Smithers Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6509. Study sponsored by Valent U.S.A. Corporation. Study completed April 12, 2008.  109 p. 
48400022
Softcheck, K.A
2010
V-10135 T.G. (S-2188 T.G.) 96-Hour Toxicity Test with the Marine Diatom, Skeletonema costatum, Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 12079.6307. Study sponsored by Valent U.S.A. Corporation. Study completed November 18, 2010.  89 p.
48400023
Softcheck, K.A
2010
V-10135 T.G. (S-2188 T.G.) 96-Hour Toxicity Test with the Freshwater Diatom, Navicula pelliculosa, Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 12079.6304. Study sponsored by Valent U.S.A. Corporation. Study completed November 17, 2010.  89 p.  
48400024
Softcheck, K.A
2010
V-10135 T.G. (S-2188 T.G.) 96-Hour Toxicity Test with the Freshwater Blue-Green Alga, Anabaena flos-aquae, Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 12079.6306. Study sponsored by Valent U.S.A. Corporation. Study completed December 2, 2010.  93p. 
48400025
Teixeira, D
2006
S-2188 Technical Grade- Acute Toxicity to Earthworms (Eisenia fetida). Unpublished study performed by Springborn Smithers Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6512. Study sponsored by Valent U.S.A. Corporation. Study completed April 11, 2006.  38 p.
 
 
 
 
 Open Literature and Government Reports 
 
 Burns, Lawrence, 1997. Exposure Analysis Modeling System (EXAMS): User Manual and System Documentation. Ecosystem Research Division, National Exposure Research Laboratory. U. S. Environmental Protection Agency, Athens, GA.
 
 Carsel, R. F., J. C. Imhoff, P. R. Humel, J. M. Cheplick, and A. S. Donigian, Jr. 1997. PRZM-3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Zones: User's Manual for Release 3.0. National Exposure Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.
 
 Fungicide Resistance Action Committee. FRAC code list:  Fungicides sorted by mode of action. 2009. http://www.frac.info/frac/publication/anhang/FRAC_CODE_LIST.pdf   
 
 Terrestrial Residue Exposure Model (T-REX), Version 1.5.  April 2012.  Environmental Fate and Effects Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C.
 
 US EPA. 1996. Ecological Effects Test Guidelines, 850.2100 Avian Acute Oral Toxicity Test. Office of Chemical Safety and Pollution Prevention. EPA 712-C-96-139.
 
 US EPA. 2002. Technical Basis for the Derivation of Equilibrium Partitioning Sediment Guidelines (ESGs) for the Protection of Benthic Organisms:  Nonionic Organics. Office of Science and Technology and Office of Research and Development. Washington, DC 20460. EPA/822-R-02-041.
 
 US EPA. 2004a. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency: Endangered and Threatened Species Effects Determinations.  Office of Prevention, Pesticide, and Toxic Substances.
 
 USEPA. 2004b.  Scientific Advisory Panel.  March 30 - April 2, 2004: Refined (Level II) Terrestrial and Aquatic Models for Probabilistic and Ecological Assessment of Pesticides.  Available: http://www.epa.gov/scipoly/sap/meetings/2004/033004_mtg.htm 
 
US Office of the Federal Registrar. 2011. Code of Federal Regulations 40, Parts 150-189. 
 
 Willis and McDowell, 1987. Pesticide persistence on foliage. Environ. Contam. Toxicol.  100:23-73.
          Appendix A.  The Risk Quotient Method and Levels of Concern

The Risk Quotient Method is the means by which the Environmental Fate and Effects Division (EFED) integrates the results of exposure and ecotoxicity data. In this method, both acute and chronic risk quotients (RQs) are calculated by dividing exposure estimates by the most sensitive ecotoxicity values or toxicity endpoints derived from the studies. Calculated RQs are then compared to OPP's levels of concern (LOCs). The LOCs are the criteria used by OPP to indicate potential risk to non-target organisms and the need to consider regulatory action. EFED has defined LOCs for acute risk, potential restricted use, and for endangered species. Risk presumptions, along with the corresponding RQs and LOCs are summarized in the table below.

These LOCs are criteria used by EFED to indicate potential risk to non-target organisms and the need to consider regulatory action.  The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on non-target organisms.  LOCs currently address the following risk presumption categories: (1) acute  -  potential for acute risk is high, regulatory action may be warranted in addition to restricted use classification (2) acute restricted use -  potential for acute risk is high, but this may be mitigated through restricted use classification (3) acute endangered species  -  the potential for acute risk to endangered species is high, regulatory action may be warranted, and (4)  chronic risk -  the potential for chronic risk high, regulatory action may be warranted.  Currently, EFED does not perform assessment for chronic risk to plants, acute or chronic risks to non-target insects or chronic risks from granular/bait formulations to mammalian or avian species.

The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk quotients are derived from the results of required studies.  Examples of ecotoxicity values derived from results of short-term laboratory studies that assess acute effects are (1) LC50 (fish and birds), (2) LD50 (birds and mammals), (3) EC50 (aquatic plants and aquatic invertebrates, and (4) EC25 (terrestrial plants).  An example of a toxicity test effect level derived from the results of a long-term laboratory study that assesses chronic effects is (1) NOAEC (birds, fish, and aquatic invertebrates).    

                               Risk Presumption
                                      RQ
                                      LOC
Birds

                                  Acute Risk
                       EEC/LC50 or LD50/sqft or LD50/day
                                      0.5

                             Acute Restricted Use
           EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
                                      0.2

                           Acute Endangered Species
                       EEC/LC50 or LD50/sqft or LD50/day
                                      0.1

                                 Chronic Risk
                                   EEC/NOAEC
                                       1
Mammals

                                  Acute Risk
                       EEC/LC50 or LD50/sqft or LD50/day
                                      0.5

                             Acute Restricted Use
           EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
                                      0.2

                           Acute Endangered Species
                       EEC/LC50 or LD50/sqft or LD50/day
                                      0.1

                                 Chronic Risk
                                   EEC/NOAEC
                                       1
Aquatic Animals



                                  Acute Risk
                               EEC/LC50 or EC50
                                      0.5

                             Acute Restricted Use
                               EEC/LC50 or EC50
                                      0.1

                           Acute Endangered Species
                               EEC/LC50 or EC50
                                     0.05

                                 Chronic Risk
                                   EEC/NOAEC
                                       1
Terrestrial and Semi-Aquatic Plants 

                                  Acute Risk
                                   EEC/EC25
                                       1

                           Acute Endangered Species
                               EEC/EC05 or NOAEC
                                       1
Aquatic Plants

                                  Acute Risk
                                   EEC/EC50
                                       1

                           Acute Endangered Species
                               EEC/EC05 or NOAEC
                                       1
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                 Appendix Appendix B.  Output of STIR Results

Welcome to the EFED 
 
 
 
 
Screening Tool for Inhalation Risk
 
 
 
This tool is designed to provide the risk assessor with a rapid method for determining the potential
 
 
significance of the inhalation exposure route to birds and mammals in a risk assessment.
 
 
 
 
 
 
 
Input
 

 

 
 
Application and Chemical Information
 
 
 
 
Enter Chemical Name
                                                                  Fenpyrazamine
 
 
 
Enter Chemical Use
                                                                              
 
 
 
Is the Application a Spray? (enter y or n)
                                                                              y
 
 
 
If Spray What Type (enter ground or air)
                                                                            air
 
 
 
Enter Chemical Molecular Weight (g/mole)
                                                                          331.4
 
 
 
Enter Chemical Vapor Pressure (mmHg)
                                                                       2.17E-10
 
 
 
Enter Application Rate (lb a.i./acre)
                                                                           1.07
 
 
 
 
 
 
 
 
Toxicity Properties
 
 
 
 
Bird
 
 
 
 
Enter Lowest Bird Oral LD50 (mg/kg bw)
                                                                           2000
 
 
 
Enter Mineau Scaling Factor
                                                                           1.15
 
 
 
Enter Tested Bird Weight (kg)
                                                                          0.178
 
 
 
Mammal
 
 
 
 
Enter Lowest Rat Oral LD50 (mg/kg bw)
                                                                           2000
 
 
 
Enter Lowest Rat Inhalation LC50 (mg/L)
                                                                           0.61
 
 
 
Duration of Rat Inhalation Study (hrs)
                                                                              4
 
 
 
Enter Rat Weight (kg)
                                                                           0.35
 
 
 
 
 
 
 
 
Output
 
 
 
 
Results Avian (0.020 kg )
 
 
 
 
Maximum Vapor Concentration in Air at Saturation (mg/m[3])
                                                                       3.87E-06
 
 
 
Maximum 1-hour Vapor Inhalation Dose (mg/kg)
                                                                       4.86E-07
 
 
 
Adjusted Inhalation  LD50 
                                                                       3.40E+00
 
 
 
Ratio of Vapor Dose to Adjusted Inhalation LD50
                                                                       1.43E-07
Exposure not Likely Significant
 
 
Maximum Post-treatment Spray Inhalation Dose (mg/kg)
                                                                       1.03E-01
 
 
 
Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD50 
                                                                       3.02E-02
Exposure not Likely Significant
 
 
 
 
 
 
 
Results Mammalian (0.015 kg )
 
 
 
 
Maximum Vapor Concentration in Air at Saturation (mg/m[3])
                                                                       3.87E-06
 
 
 
Maximum 1-hour Vapor Inhalation Dose (mg/kg)
                                                                       6.12E-07
 
 
 
Adjusted Inhalation  LD50 
                                                                       3.63E+01
 
 
 
Ratio of Vapor Dose to Adjusted Inhalation LD50
                                                                       1.68E-08
Exposure not Likely Significant
 
 
Maximum Post-treatment Spray Inhalation Dose (mg/kg)
                                                                       1.29E-01
 
 
 
Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD50 
                                                                       3.56E-03
Exposure not Likely Significant
 
 




























                  Appendix Appendix C.  Output of SIP Results
                                       
 
 
 
Table 1. Inputs
 
 
Parameter
                                     Value
 
Chemical name
                                 Fenpyrazamine
 
Solubility (in water at 25[o]C; mg/L)
                                     20.4
 
 
                                       
 
Mammalian LD50 (mg/kg-bw)
                                     2000
 
Mammalian test species
                                laboratory rat
 
Body weight (g) of "other" mammalian species
                                       
 
 
                                       
 
Mammalian NOAEL (mg/kg-bw)
                                     3000
 
Mammalian test species
                                laboratory rat
 
Body weight (g) of "other" mammalian species
                                       
 
 
                                       
 
Avian LD50 (mg/kg-bw)
                                     2000
 
Avian test species
                            northern bobwhite quail
 
Body weight (g) of "other" avian species
                                       
 
Mineau scaling factor
                                     1.15
 
 
                                       
 
Mallard NOAEC (mg/kg-diet)
                                      517
 
Bobwhite quail NOAEC (mg/kg-diet)
                                      248
 
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)
                                    3.5088
                                    3.5088
Adjusted toxicity value (mg/kg-bw)
                                   1538.3211
                                   2307.4817
Ratio of exposure to toxicity
                                    0.0023
                                    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)
                                    16.5240
                                    16.5240
Adjusted toxicity value (mg/kg-bw)
                                   1440.8590
                                    25.6497
Ratio of exposure to acute toxicity
                                    0.0115
                                    0.6442
Conclusion*
      Drinking water exposure alone is NOT a potential concern for birds
      Drinking water exposure alone is NOT a potential concern for birds
 
 
 
*Conclusion is for drinking water exposure alone.  This does not combine all routes of exposure.  Therefore, when aggregated with other routes (i.e., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non-target animals.






































               Appendix Appendix D.  Output of TerrPlant Results
                                       
                                       
TerrPlant v. 1.2.2
 
 
 
 
Table 1. Chemical Identity.
 
                                 Chemical Name
Fenpyrazamine
 
                                    PC code
90109
 
                                      Use
Almonds, pistachios
                                       
                              Application Method
Aerial
                                       
                               Application Form
Suspension concentrate
                                        
                           Solubility in Water (ppm)
20.4
                                       
                                       
                                       
                                       
                                       
                                       
Table 2. Input parameters used to derive EECs.
 
                                Input Parameter
                                    Symbol
                                     Value
                                     Units
                                       
                               Application Rate
                                       A
                                     0.37
                                       
                                       
                                 Incorporation
                                       I
                                       1
                                     none
                                       
                                Runoff Fraction
                                       R
                                     0.02
                                     none
                                       
                                Drift Fraction
                                       D
                                     0.05
                                     none
                                       
 
 
 
 
 
Table 3. EECs for Fenpyrazamine.  Units in .
 
                                  Description
                                   Equation
                                      EEC
                                       
                              Runoff to dry areas
                                    (A/I)*R
                                    0.0074
                                       
                         Runoff to semi-aquatic areas
                                  (A/I)*R*10
                                     0.074
                                       
                                  Spray drift
                                      A*D
                                    0.0185
                                       
                              Total for dry areas
                                ((A/I)*R)+(A*D)
                                    0.0259
                                       
                         Total for semi-aquatic areas
                              ((A/I)*R*10)+(A*D)
                                    0.0925
                                       
 
 
 
 
 
Table 4. Plant survival and growth data used for RQ derivation. Units are in .
 
                              Seedling Emergence
                               Vegetative Vigor
                                  Plant type
                                     EC25
                                    NOAEC 
                                     EC25
                                    NOAEC 
                                    Monocot
                                     1.54
                                     0.15
                                       x
                                     0.56
                                     Dicot
                                     0.53
                                     0.035
                                       x
                                     0.56
 
                                       
                                       
                                       
                                       
Table 5. RQ values for plants in dry and semi-aquatic areas exposed to Fenpyrazamine through runoff and/or spray drift.*
                                  Plant Type
                                 Listed Status
                                     Dry 
                                 Semi-Aquatic
                                  Spray Drift
                                    Monocot
                                  non-listed
                                    <0.1
                                    <0.1
                                    <0.1
                                    Monocot
                                    listed
                                     0.17
                                     0.62
                                     0.12
                                     Dicot
                                  non-listed
                                    <0.1
                                     0.17
                                    <0.1
                                     Dicot
                                    listed 
                                     0.74
                                     2.64
                                     0.53
*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.
 
 
 
 
 
Table 1. Chemical Identity.
 
                                 Chemical Name
Fenpyrazamine
 
                                    PC code
90109
 
                                      Use
Almonds, pistachios
                                       
                              Application Method
Aerial
                                       
                               Application Form
Suspension concentrate
                                        
                           Solubility in Water (ppm)
204
                                       
                                       
                                       
                                       
                                       
                                       
Table 2. Input parameters used to derive EECs.
 
                                Input Parameter
                                    Symbol
                                     Value
                                     Units
                                       
                               Application Rate
                                       A
                                     0.49
                                       
                                       
                                 Incorporation
                                       I
                                       1
                                     none
                                       
                                Runoff Fraction
                                       R
                                     0.02
                                     none
                                       
                                Drift Fraction
                                       D
                                     0.05
                                     none
                                       
 
 
 
 
 
Table 3. EECs for Fenpyrazamine.  Units in .
 
                                  Description
                                   Equation
                                      EEC
                                       
                              Runoff to dry areas
                                    (A/I)*R
                                    0.0098
                                       
                         Runoff to semi-aquatic areas
                                  (A/I)*R*10
                                     0.098
                                       
                                  Spray drift
                                      A*D
                                    0.0245
                                       
                              Total for dry areas
                                ((A/I)*R)+(A*D)
                                    0.0343
                                       
                         Total for semi-aquatic areas
                              ((A/I)*R*10)+(A*D)
                                    0.1225
                                       
 
 
 
 
 
Table 4. Plant survival and growth data used for RQ derivation. Units are in .
 
                              Seedling Emergence
                               Vegetative Vigor
                                  Plant type
                                     EC25
                                    NOAEC 
                                     EC25
                                    NOAEC 
                                    Monocot
                                     1.54
                                     0.15
                                       x
                                     0.56
                                     Dicot
                                     0.53
                                     0.035
                                       x
                                     0.56
 
                                       
                                       
                                       
                                       
Table 5. RQ values for plants in dry and semi-aquatic areas exposed to Fenpyrazamine through runoff and/or spray drift.*
                                  Plant Type
                                 Listed Status
                                     Dry 
                                 Semi-Aquatic
                                  Spray Drift
                                    Monocot
                                  non-listed
                                    <0.1
                                    <0.1
                                    <0.1
                                    Monocot
                                    listed
                                     0.23
                                     0.82
                                     0.16
                                     Dicot
                                  non-listed
                                    <0.1
                                     0.23
                                    <0.1
                                     Dicot
                                    listed 
                                     0.98
                                     3.50
                                     0.70
*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.




 
 
 
 
 
Table 1. Chemical Identity.
 
                                 Chemical Name
Fenpyrazamine
 
                                    PC code
90109
 
                                      Use
Almonds, pistachios
                                       
                              Application Method
Aerial
                                       
                               Application Form
Suspension concentrate
                                        
                           Solubility in Water (ppm)
204
                                       
                                       
                                       
                                       
                                       
                                       
Table 2. Input parameters used to derive EECs.
 
                                Input Parameter
                                    Symbol
                                     Value
                                     Units
                                       
                               Application Rate
                                       A
                                     1.07
                                       
                                       
                                 Incorporation
                                       I
                                       1
                                     none
                                       
                                Runoff Fraction
                                       R
                                     0.02
                                     none
                                       
                                Drift Fraction
                                       D
                                     0.05
                                     none
                                       
 
 
 
 
 
Table 3. EECs for Fenpyrazamine.  Units in .
 
                                  Description
                                   Equation
                                      EEC
                                       
                              Runoff to dry areas
                                    (A/I)*R
                                    0.0214
                                       
                         Runoff to semi-aquatic areas
                                  (A/I)*R*10
                                     0.214
                                       
                                  Spray drift
                                      A*D
                                    0.0535
                                       
                              Total for dry areas
                                ((A/I)*R)+(A*D)
                                    0.0749
                                       
                         Total for semi-aquatic areas
                              ((A/I)*R*10)+(A*D)
                                    0.2675
                                       
 
 
 
 
 
Table 4. Plant survival and growth data used for RQ derivation. Units are in .
 
                              Seedling Emergence
                               Vegetative Vigor
                                  Plant type
                                     EC25
                                    NOAEC 
                                     EC25
                                    NOAEC 
                                    Monocot
                                     1.54
                                     0.15
                                       x
                                     0.56
                                     Dicot
                                     0.53
                                     0.035
                                       x
                                     0.56
 
                                       
                                       
                                       
                                       
Table 5. RQ values for plants in dry and semi-aquatic areas exposed to Fenpyrazamine through runoff and/or spray drift.*
                                  Plant Type
                                 Listed Status
                                     Dry 
                                 Semi-Aquatic
                                  Spray Drift
                                    Monocot
                                  non-listed
                                    <0.1
                                     0.17
                                    <0.1
                                    Monocot
                                    listed
                                     0.50
                                     1.78
                                     0.36
                                     Dicot
                                  non-listed
                                     0.14
                                     0.50
                                     0.10
                                     Dicot
                                    listed 
                                     2.14
                                     7.64
                                     1.53
*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.



        Appendix Appendix E.  Sample PRZM/EXAMS Input and Output Files

Figure E-1.  PE5 water column run for aerial application, NJ Nursery scenario.

stored as Aerial_NJNU.out
Chemical: Fenpyrazamine
PRZM environment: NJnurserySTD.txt	modified Tueday, 26 August 2008 at 06:16:42
EXAMS environment: pond298.exv	modified Tueday, 26 August 2008 at 06:14:08
Metfile: w93730.dvf	modified Tueday, 26 August 2008 at 06:16:14
Water segment concentrations (ppb)

Year
Peak
96 hr
21 Day
60 Day
90 Day
Yearly
                                                                           1961
                                                                          20.84
                                                                          20.62
                                                                          20.06
                                                                          18.76
                                                                          17.88
                                                                          6.544
                                                                           1962
                                                                          56.86
                                                                          56.25
                                                                          54.06
                                                                          51.07
                                                                          48.62
                                                                          23.86
                                                                           1963
                                                                          40.79
                                                                          40.42
                                                                          39.11
                                                                          37.47
                                                                          36.37
                                                                          31.54
                                                                           1964
                                                                          36.26
                                                                          35.91
                                                                          34.99
                                                                          33.85
                                                                          32.95
                                                                          25.08
                                                                           1965
                                                                          30.86
                                                                          30.57
                                                                          29.95
                                                                          28.98
                                                                          27.85
                                                                          22.02
                                                                           1966
                                                                            102
                                                                            101
                                                                           96.8
                                                                          91.72
                                                                          87.17
                                                                          40.35
                                                                           1967
                                                                          92.14
                                                                          91.32
                                                                          88.16
                                                                          83.14
                                                                           80.2
                                                                          59.62
                                                                           1968
                                                                          59.26
                                                                          59.17
                                                                          58.81
                                                                          57.96
                                                                           56.7
                                                                          47.13
                                                                           1969
                                                                          36.97
                                                                          36.92
                                                                          36.67
                                                                          35.66
                                                                          34.41
                                                                          29.07
                                                                           1970
                                                                          36.45
                                                                          36.08
                                                                          35.69
                                                                          34.35
                                                                          33.08
                                                                          24.22
                                                                           1971
                                                                          89.46
                                                                          88.64
                                                                          85.88
                                                                          82.33
                                                                          79.12
                                                                          40.89
                                                                           1972
                                                                          61.57
                                                                          61.21
                                                                          59.72
                                                                          56.55
                                                                          54.32
                                                                          44.22
                                                                           1973
                                                                          40.31
                                                                          39.92
                                                                          38.37
                                                                          35.55
                                                                          34.28
                                                                          28.23
                                                                           1974
                                                                          43.58
                                                                          43.14
                                                                          42.01
                                                                          40.74
                                                                          39.57
                                                                          26.56
                                                                           1975
                                                                          45.24
                                                                          44.96
                                                                          43.49
                                                                          41.27
                                                                          40.14
                                                                          28.55
                                                                           1976
                                                                          68.94
                                                                          68.19
                                                                          66.31
                                                                          62.56
                                                                          59.64
                                                                          36.79
                                                                           1977
                                                                          59.52
                                                                          58.91
                                                                          56.89
                                                                          53.98
                                                                          51.87
                                                                          40.57
                                                                           1978
                                                                          39.92
                                                                          39.53
                                                                          39.05
                                                                          38.45
                                                                          37.57
                                                                          32.76
                                                                           1979
                                                                          34.32
                                                                          34.07
                                                                          33.39
                                                                          32.35
                                                                          31.51
                                                                          24.59
                                                                           1980
                                                                          34.78
                                                                          34.45
                                                                          33.86
                                                                          33.03
                                                                          32.02
                                                                          23.58
                                                                           1981
                                                                          31.05
                                                                          30.84
                                                                          30.16
                                                                          29.18
                                                                          28.23
                                                                           22.9
                                                                           1982
                                                                          28.11
                                                                          27.84
                                                                           27.2
                                                                          26.54
                                                                          25.59
                                                                          19.64
                                                                           1983
                                                                           33.4
                                                                          33.04
                                                                          32.38
                                                                          31.07
                                                                          29.85
                                                                          19.83
                                                                           1984
                                                                          28.47
                                                                           28.2
                                                                          27.89
                                                                          26.95
                                                                          26.05
                                                                          20.29
                                                                           1985
                                                                          32.04
                                                                          31.82
                                                                           30.6
                                                                          29.64
                                                                          28.49
                                                                          19.62
                                                                           1986
                                                                           34.1
                                                                          33.74
                                                                          32.33
                                                                          30.67
                                                                          29.57
                                                                          20.07
                                                                           1987
                                                                          31.98
                                                                          31.68
                                                                          31.18
                                                                          30.14
                                                                          29.18
                                                                             22
                                                                           1988
                                                                          33.29
                                                                          32.96
                                                                          31.69
                                                                           29.7
                                                                          28.76
                                                                           20.9
                                                                           1989
                                                                          58.56
                                                                          58.01
                                                                          57.33
                                                                          53.82
                                                                          52.81
                                                                          29.57
                                                                           1990
                                                                          47.16
                                                                          46.86
                                                                          45.06
                                                                          41.98
                                                                          40.16
                                                                          34.26







Sorted results





Prob.
Peak
96 hr
21 Day
60 Day
90 Day
Yearly
                                                                       0.032258
                                                                            102
                                                                            101
                                                                           96.8
                                                                          91.72
                                                                          87.17
                                                                          59.62
                                                                       0.064516
                                                                          92.14
                                                                          91.32
                                                                          88.16
                                                                          83.14
                                                                           80.2
                                                                          47.13
                                                                       0.096774
                                                                          89.46
                                                                          88.64
                                                                          85.88
                                                                          82.33
                                                                          79.12
                                                                          44.22
                                                                       0.129032
                                                                          68.94
                                                                          68.19
                                                                          66.31
                                                                          62.56
                                                                          59.64
                                                                          40.89
                                                                        0.16129
                                                                          61.57
                                                                          61.21
                                                                          59.72
                                                                          57.96
                                                                           56.7
                                                                          40.57
                                                                       0.193548
                                                                          59.52
                                                                          59.17
                                                                          58.81
                                                                          56.55
                                                                          54.32
                                                                          40.35
                                                                       0.225806
                                                                          59.26
                                                                          58.91
                                                                          57.33
                                                                          53.98
                                                                          52.81
                                                                          36.79
                                                                       0.258065
                                                                          58.56
                                                                          58.01
                                                                          56.89
                                                                          53.82
                                                                          51.87
                                                                          34.26
                                                                       0.290323
                                                                          56.86
                                                                          56.25
                                                                          54.06
                                                                          51.07
                                                                          48.62
                                                                          32.76
                                                                       0.322581
                                                                          47.16
                                                                          46.86
                                                                          45.06
                                                                          41.98
                                                                          40.16
                                                                          31.54
                                                                       0.354839
                                                                          45.24
                                                                          44.96
                                                                          43.49
                                                                          41.27
                                                                          40.14
                                                                          29.57
                                                                       0.387097
                                                                          43.58
                                                                          43.14
                                                                          42.01
                                                                          40.74
                                                                          39.57
                                                                          29.07
                                                                       0.419355
                                                                          40.79
                                                                          40.42
                                                                          39.11
                                                                          38.45
                                                                          37.57
                                                                          28.55
                                                                       0.451613
                                                                          40.31
                                                                          39.92
                                                                          39.05
                                                                          37.47
                                                                          36.37
                                                                          28.23
                                                                       0.483871
                                                                          39.92
                                                                          39.53
                                                                          38.37
                                                                          35.66
                                                                          34.41
                                                                          26.56
                                                                       0.516129
                                                                          36.97
                                                                          36.92
                                                                          36.67
                                                                          35.55
                                                                          34.28
                                                                          25.08
                                                                       0.548387
                                                                          36.45
                                                                          36.08
                                                                          35.69
                                                                          34.35
                                                                          33.08
                                                                          24.59
                                                                       0.580645
                                                                          36.26
                                                                          35.91
                                                                          34.99
                                                                          33.85
                                                                          32.95
                                                                          24.22
                                                                       0.612903
                                                                          34.78
                                                                          34.45
                                                                          33.86
                                                                          33.03
                                                                          32.02
                                                                          23.86
                                                                       0.645161
                                                                          34.32
                                                                          34.07
                                                                          33.39
                                                                          32.35
                                                                          31.51
                                                                          23.58
                                                                       0.677419
                                                                           34.1
                                                                          33.74
                                                                          32.38
                                                                          31.07
                                                                          29.85
                                                                           22.9
                                                                       0.709677
                                                                           33.4
                                                                          33.04
                                                                          32.33
                                                                          30.67
                                                                          29.57
                                                                          22.02
                                                                       0.741935
                                                                          33.29
                                                                          32.96
                                                                          31.69
                                                                          30.14
                                                                          29.18
                                                                             22
                                                                       0.774194
                                                                          32.04
                                                                          31.82
                                                                          31.18
                                                                           29.7
                                                                          28.76
                                                                           20.9
                                                                       0.806452
                                                                          31.98
                                                                          31.68
                                                                           30.6
                                                                          29.64
                                                                          28.49
                                                                          20.29
                                                                        0.83871
                                                                          31.05
                                                                          30.84
                                                                          30.16
                                                                          29.18
                                                                          28.23
                                                                          20.07
                                                                       0.870968
                                                                          30.86
                                                                          30.57
                                                                          29.95
                                                                          28.98
                                                                          27.85
                                                                          19.83
                                                                       0.903226
                                                                          28.47
                                                                           28.2
                                                                          27.89
                                                                          26.95
                                                                          26.05
                                                                          19.64
                                                                       0.935484
                                                                          28.11
                                                                          27.84
                                                                           27.2
                                                                          26.54
                                                                          25.59
                                                                          19.62
                                                                       0.967742
                                                                          20.84
                                                                          20.62
                                                                          20.06
                                                                          18.76
                                                                          17.88
                                                                          6.544







                                                                            0.1
                                                                         87.408
                                                                         86.595
                                                                         83.923
                                                                         80.353
                                                                         77.172
                                                                         43.887



Average of yearly averages:
                                                                        28.8418


Figure E-2.  PE5 benthic pore water run for aerial application, NJ Nursery scenario.
                                       

stored as Aerial_NJNUben.out
Chemical: Fenpyrazamine
PRZM environment: NJnurserySTD.txt	modified Tueday, 26 August 2008 at 06:16:42
EXAMS environment: pond298.exv	modified Tueday, 26 August 2008 at 06:14:08
Metfile: w93730.dvf	modified Tueday, 26 August 2008 at 06:16:14
Benthic segment concentrations (ppb)

Year
Peak
96 hr
21 Day
60 Day
90 Day
Yearly
                                                                           1961
                                                                          10.79
                                                                          10.79
                                                                          10.69
                                                                          10.18
                                                                          9.461
                                                                          2.885
                                                                           1962
                                                                          28.57
                                                                          28.56
                                                                          28.49
                                                                          27.63
                                                                          26.34
                                                                          13.49
                                                                           1963
                                                                          28.56
                                                                          28.54
                                                                          28.48
                                                                          28.25
                                                                          27.84
                                                                          20.72
                                                                           1964
                                                                          21.77
                                                                          21.77
                                                                          21.74
                                                                          21.44
                                                                          20.94
                                                                           16.3
                                                                           1965
                                                                          19.54
                                                                          19.52
                                                                          19.45
                                                                          19.21
                                                                          18.87
                                                                          14.58
                                                                           1966
                                                                          49.55
                                                                          49.55
                                                                          49.42
                                                                          48.22
                                                                          46.12
                                                                          22.41
                                                                           1967
                                                                          49.54
                                                                          49.51
                                                                          49.26
                                                                          48.22
                                                                          47.33
                                                                          39.86
                                                                           1968
                                                                          47.26
                                                                          47.18
                                                                          46.85
                                                                          46.12
                                                                          45.37
                                                                          32.24
                                                                           1969
                                                                          28.95
                                                                          28.92
                                                                          28.78
                                                                          28.38
                                                                          27.88
                                                                          19.71
                                                                           1970
                                                                          19.79
                                                                          19.79
                                                                          19.75
                                                                          19.55
                                                                          19.23
                                                                          15.51
                                                                           1971
                                                                          46.32
                                                                          46.32
                                                                          46.23
                                                                          44.76
                                                                          42.65
                                                                          23.26
                                                                           1972
                                                                          46.31
                                                                          46.31
                                                                          46.22
                                                                           45.4
                                                                          44.41
                                                                          30.94
                                                                           1973
                                                                          26.82
                                                                          26.81
                                                                          26.68
                                                                          26.08
                                                                          25.26
                                                                          18.55
                                                                           1974
                                                                          23.24
                                                                          23.24
                                                                          23.21
                                                                          22.76
                                                                          21.93
                                                                          16.78
                                                                           1975
                                                                          24.39
                                                                          24.38
                                                                          24.29
                                                                          23.66
                                                                          22.81
                                                                          18.32
                                                                           1976
                                                                          35.31
                                                                          35.31
                                                                          35.25
                                                                          34.63
                                                                          33.43
                                                                          23.04
                                                                           1977
                                                                          35.32
                                                                          35.32
                                                                          35.29
                                                                          35.01
                                                                          34.26
                                                                          26.21
                                                                           1978
                                                                           30.1
                                                                          30.09
                                                                          30.04
                                                                          29.84
                                                                          29.57
                                                                          22.15
                                                                           1979
                                                                          21.68
                                                                          21.66
                                                                          21.53
                                                                          21.06
                                                                          20.58
                                                                          16.09
                                                                           1980
                                                                          19.76
                                                                          19.76
                                                                          19.66
                                                                          19.17
                                                                          18.36
                                                                          15.18
                                                                           1981
                                                                          19.83
                                                                          19.83
                                                                          19.83
                                                                          19.73
                                                                          19.47
                                                                          15.05
                                                                           1982
                                                                           16.8
                                                                          16.79
                                                                          16.74
                                                                          16.54
                                                                          16.19
                                                                          12.69
                                                                           1983
                                                                          17.47
                                                                          17.47
                                                                          17.43
                                                                          16.98
                                                                          16.32
                                                                           12.3
                                                                           1984
                                                                          17.47
                                                                          17.46
                                                                          17.42
                                                                          17.21
                                                                          16.92
                                                                          13.03
                                                                           1985
                                                                          16.01
                                                                             16
                                                                          15.91
                                                                          15.52
                                                                          15.12
                                                                          12.15
                                                                           1986
                                                                          17.47
                                                                          17.47
                                                                          17.42
                                                                           16.9
                                                                          16.19
                                                                          12.67
                                                                           1987
                                                                          17.47
                                                                          17.47
                                                                          17.43
                                                                           17.3
                                                                          17.09
                                                                          14.06
                                                                           1988
                                                                          17.28
                                                                          17.26
                                                                          17.19
                                                                          16.97
                                                                          16.61
                                                                          13.52
                                                                           1989
                                                                          32.52
                                                                          32.49
                                                                          32.16
                                                                          30.96
                                                                          29.39
                                                                          17.37
                                                                           1990
                                                                          32.65
                                                                          32.65
                                                                          32.62
                                                                          32.13
                                                                          31.33
                                                                           22.9







Sorted results





Prob.
Peak
96 hr
21 Day
60 Day
90 Day
Yearly
                                                                       0.032258
                                                                          49.55
                                                                          49.55
                                                                          49.42
                                                                          48.22
                                                                          47.33
                                                                          39.86
                                                                       0.064516
                                                                          49.54
                                                                          49.51
                                                                          49.26
                                                                          48.22
                                                                          46.12
                                                                          32.24
                                                                       0.096774
                                                                          47.26
                                                                          47.18
                                                                          46.85
                                                                          46.12
                                                                          45.37
                                                                          30.94
                                                                       0.129032
                                                                          46.32
                                                                          46.32
                                                                          46.23
                                                                           45.4
                                                                          44.41
                                                                          26.21
                                                                        0.16129
                                                                          46.31
                                                                          46.31
                                                                          46.22
                                                                          44.76
                                                                          42.65
                                                                          23.26
                                                                       0.193548
                                                                          35.32
                                                                          35.32
                                                                          35.29
                                                                          35.01
                                                                          34.26
                                                                          23.04
                                                                       0.225806
                                                                          35.31
                                                                          35.31
                                                                          35.25
                                                                          34.63
                                                                          33.43
                                                                           22.9
                                                                       0.258065
                                                                          32.65
                                                                          32.65
                                                                          32.62
                                                                          32.13
                                                                          31.33
                                                                          22.41
                                                                       0.290323
                                                                          32.52
                                                                          32.49
                                                                          32.16
                                                                          30.96
                                                                          29.57
                                                                          22.15
                                                                       0.322581
                                                                           30.1
                                                                          30.09
                                                                          30.04
                                                                          29.84
                                                                          29.39
                                                                          20.72
                                                                       0.354839
                                                                          28.95
                                                                          28.92
                                                                          28.78
                                                                          28.38
                                                                          27.88
                                                                          19.71
                                                                       0.387097
                                                                          28.57
                                                                          28.56
                                                                          28.49
                                                                          28.25
                                                                          27.84
                                                                          18.55
                                                                       0.419355
                                                                          28.56
                                                                          28.54
                                                                          28.48
                                                                          27.63
                                                                          26.34
                                                                          18.32
                                                                       0.451613
                                                                          26.82
                                                                          26.81
                                                                          26.68
                                                                          26.08
                                                                          25.26
                                                                          17.37
                                                                       0.483871
                                                                          24.39
                                                                          24.38
                                                                          24.29
                                                                          23.66
                                                                          22.81
                                                                          16.78
                                                                       0.516129
                                                                          23.24
                                                                          23.24
                                                                          23.21
                                                                          22.76
                                                                          21.93
                                                                           16.3
                                                                       0.548387
                                                                          21.77
                                                                          21.77
                                                                          21.74
                                                                          21.44
                                                                          20.94
                                                                          16.09
                                                                       0.580645
                                                                          21.68
                                                                          21.66
                                                                          21.53
                                                                          21.06
                                                                          20.58
                                                                          15.51
                                                                       0.612903
                                                                          19.83
                                                                          19.83
                                                                          19.83
                                                                          19.73
                                                                          19.47
                                                                          15.18
                                                                       0.645161
                                                                          19.79
                                                                          19.79
                                                                          19.75
                                                                          19.55
                                                                          19.23
                                                                          15.05
                                                                       0.677419
                                                                          19.76
                                                                          19.76
                                                                          19.66
                                                                          19.21
                                                                          18.87
                                                                          14.58
                                                                       0.709677
                                                                          19.54
                                                                          19.52
                                                                          19.45
                                                                          19.17
                                                                          18.36
                                                                          14.06
                                                                       0.741935
                                                                          17.47
                                                                          17.47
                                                                          17.43
                                                                           17.3
                                                                          17.09
                                                                          13.52
                                                                       0.774194
                                                                          17.47
                                                                          17.47
                                                                          17.43
                                                                          17.21
                                                                          16.92
                                                                          13.49
                                                                       0.806452
                                                                          17.47
                                                                          17.47
                                                                          17.42
                                                                          16.98
                                                                          16.61
                                                                          13.03
                                                                        0.83871
                                                                          17.47
                                                                          17.46
                                                                          17.42
                                                                          16.97
                                                                          16.32
                                                                          12.69
                                                                       0.870968
                                                                          17.28
                                                                          17.26
                                                                          17.19
                                                                           16.9
                                                                          16.19
                                                                          12.67
                                                                       0.903226
                                                                           16.8
                                                                          16.79
                                                                          16.74
                                                                          16.54
                                                                          16.19
                                                                           12.3
                                                                       0.935484
                                                                          16.01
                                                                             16
                                                                          15.91
                                                                          15.52
                                                                          15.12
                                                                          12.15
                                                                       0.967742
                                                                          10.79
                                                                          10.79
                                                                          10.69
                                                                          10.18
                                                                          9.461
                                                                          2.885







                                                                            0.1
                                                                         47.166
                                                                         47.094
                                                                         46.788
                                                                         46.048
                                                                         45.274
                                                                         30.467



Average of yearly averages:
                                                                        18.4655


Inputs generated by pe5.pl - Novemeber 2006

Data used for this run:
Output File: Aerial_NJNU
Metfile:	w93730.dvf
PRZM scenario:	NJnurserySTD.txt
EXAMS environment file:	pond298.exv
Chemical Name:	Fenpyrazamine
Description	Variable Name	Value	Units	Comments
Molecular weight	mwt	331.4	g/mol
Henry's Law Const.	henry	2.28e-10	atm-m^3/mol
Vapor Pressure	vapr	2.17e-10	torr
Solubility	sol	20.4	mg/L
Kd	Kd	5.06	mg/L
Koc	Koc		mg/L
Photolysis half-life	kdp	1.64	days	Half-life
Aerobic Aquatic Metabolism	kbacw	551	days	Halfife
Anaerobic Aquatic Metabolism	kbacs	36.6	days	Halfife
Aerobic Soil Metabolism	asm	478.09	days	Halfife
Hydrolysis:	pH 4	0	days	Half-life
Hydrolysis:	pH 7	0	days	Half-life
Hydrolysis:	pH 9	0	days	Half-life
Method:	CAM	2	integer	See PRZM manual
Incorporation Depth:	DEPI		cm
Application Rate:	TAPP	1.22	kg/ha
Application Efficiency:	APPEFF	0.95	fraction
Spray Drift	DRFT	0.05	fraction of application rate applied to pond
Application Date	Date	01-08	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	1.22	kg/ha
Interval 2	interval	7	days	Set to 0 or delete line for single app.
app. rate 2	apprate	1.22	kg/ha
Record 17:	FILTRA	
	IPSCND	3
	UPTKF	
Record 18:	PLVKRT	
	PLDKRT	
	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)

                                       

Figure E-3.  EXAMS sediment concentration output file for aerial application, NJ Nursery scenario.

            BENTHIC SEDIMENT CONCENTRATION (mg/kg)  


  YEAR    PEAK  24HOUR  96HOUR  21 DAY  60 DAY  90 DAY  ANNUAL
  ----  ------  ------  ------  ------  ------  ------  ------
  1961   0.059   0.059   0.059   0.058   0.055   0.051   0.016
  1962   0.155   0.155   0.155   0.155   0.150   0.143   0.073
  1963   0.155   0.155   0.155   0.155   0.153   0.151   0.113
  1964   0.118   0.118   0.118   0.118   0.116   0.114   0.089
  1965   0.106   0.106   0.106   0.106   0.104   0.102   0.079
  1966   0.269   0.269   0.269   0.268   0.262   0.250   0.122
  1967   0.269   0.269   0.269   0.268   0.262   0.257   0.216
  1968   0.257   0.257   0.256   0.254   0.250   0.246   0.175
  1969   0.157   0.157   0.157   0.156   0.154   0.151   0.107
  1970   0.107   0.107   0.107   0.107   0.106   0.104   0.084
  1971   0.252   0.252   0.252   0.251   0.243   0.232   0.126
  1972   0.251   0.251   0.251   0.251   0.246   0.241   0.168
  1973   0.146   0.146   0.146   0.145   0.142   0.137   0.101
  1974   0.126   0.126   0.126   0.126   0.124   0.119   0.091
  1975   0.132   0.132   0.132   0.132   0.128   0.124   0.099
  1976   0.192   0.192   0.192   0.191   0.188   0.182   0.125
  1977   0.192   0.192   0.192   0.192   0.190   0.186   0.142
  1978   0.163   0.163   0.163   0.163   0.162   0.161   0.120
  1979   0.118   0.118   0.118   0.117   0.114   0.112   0.087
  1980   0.107   0.107   0.107   0.107   0.104   0.100   0.082
  1981   0.108   0.108   0.108   0.108   0.107   0.106   0.082
  1982   0.091   0.091   0.091   0.091   0.090   0.088   0.069
  1983   0.095   0.095   0.095   0.095   0.092   0.089   0.067
  1984   0.095   0.095   0.095   0.095   0.093   0.092   0.071
  1985   0.087   0.087   0.087   0.086   0.084   0.082   0.066
  1986   0.095   0.095   0.095   0.095   0.092   0.088   0.069
  1987   0.095   0.095   0.095   0.095   0.094   0.093   0.076
  1988   0.094   0.094   0.094   0.093   0.092   0.090   0.073
  1989   0.177   0.177   0.176   0.175   0.168   0.160   0.094
  1990   0.177   0.177   0.177   0.177   0.174   0.170   0.124


                       SORTED FOR PLOTTING 
                       ------ --- --------

    PROB    PEAK  24HOUR  96HOUR  21 DAY  60 DAY  90 DAY  ANNUAL
   -----  ------  ------  ------  ------  ------  ------  ------
   0.032   0.269   0.269   0.269   0.268   0.262   0.257   0.216
   0.065   0.269   0.269   0.269   0.268   0.262   0.250   0.175
   0.097   0.257   0.257   0.256   0.254   0.250   0.246   0.168
   0.129   0.252   0.252   0.252   0.251   0.246   0.241   0.142
   0.161   0.251   0.251   0.251   0.251   0.243   0.232   0.126
   0.194   0.192   0.192   0.192   0.192   0.190   0.186   0.125
   0.226   0.192   0.192   0.192   0.191   0.188   0.182   0.124
   0.258   0.177   0.177   0.177   0.177   0.174   0.170   0.122
   0.290   0.177   0.177   0.176   0.175   0.168   0.161   0.120
   0.323   0.163   0.163   0.163   0.163   0.162   0.160   0.113
   0.355   0.157   0.157   0.157   0.156   0.154   0.151   0.107
   0.387   0.155   0.155   0.155   0.155   0.153   0.151   0.101
   0.419   0.155   0.155   0.155   0.155   0.150   0.143   0.099
   0.452   0.146   0.146   0.146   0.145   0.142   0.137   0.094
   0.484   0.132   0.132   0.132   0.132   0.128   0.124   0.091
   0.516   0.126   0.126   0.126   0.126   0.124   0.119   0.089
   0.548   0.118   0.118   0.118   0.118   0.116   0.114   0.087
   0.581   0.118   0.118   0.118   0.117   0.114   0.112   0.084
   0.613   0.108   0.108   0.108   0.108   0.107   0.106   0.082
   0.645   0.107   0.107   0.107   0.107   0.106   0.104   0.082
   0.677   0.107   0.107   0.107   0.107   0.104   0.102   0.079
   0.710   0.106   0.106   0.106   0.106   0.104   0.100   0.076
   0.742   0.095   0.095   0.095   0.095   0.094   0.093   0.073
   0.774   0.095   0.095   0.095   0.095   0.093   0.092   0.073
   0.806   0.095   0.095   0.095   0.095   0.092   0.090   0.071
   0.839   0.095   0.095   0.095   0.095   0.092   0.089   0.069
   0.871   0.094   0.094   0.094   0.093   0.092   0.088   0.069
   0.903   0.091   0.091   0.091   0.091   0.090   0.088   0.067
   0.935   0.087   0.087   0.087   0.086   0.084   0.082   0.066
   0.968   0.059   0.059   0.059   0.058   0.055   0.051   0.016

    1/10   0.257   0.257   0.256   0.254   0.250   0.245   0.165


Appendix F.  Formation of Fenpyrazamine Transformation Products in Environmental Fate Studies
                                       
                                   Degradate
                                   Identity
                                   Structure
                   Max% of Applied and Days Post Application
                                   Comments
                        Hydrolysis (MRID No. 48399923)
S-2188-OH

5-Amino-4-hydroxy-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                                      NA
Metabolite detected at pH4, pH 7, and pH 9.
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                                      NA
Metabolite detected at pH 7 and pH 9.
                    Aqueous Photolysis (MRID No. 48399924)
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                               65.6 % at 7 days
Study terminated at 30 days.
MCNI

2-Cyano-N-isopropyl-2-(o-tolyl)acetamide
                                      \s
                               19.9% at 30 days
Study terminated at 30 days.
S-2188-DTC

1-Allyl-5-amino-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                6.3% at 30 days
Study terminated at 30 days.
                      Soil Photolysis (MRID No. 48399926)
S-2188-OH

5-Amino-4-hydroxy-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                               1.6 % at 30 days
Study terminated at 30 days.
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                               0.4 % at 21 days
Study terminated at 30 days.
           Aerobic Soil Metabolism (MRID Nos. 48399920 and 48399927)
S-2188-OH

5-Amino-4-hydroxy-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                               9.1 % at 181 days
Detected in NJ Silt Loam Soil (MRID No. 48399927).

Study terminated at 370 days.
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                               2.8 % at 14 days
Detected in UK Silt Loam Soil (MRID No. 48399920).

Study terminated at 120 days.
MPPZ

5-Amino-4-(o-tolyl)-1,2-dihydropyrazol-3-one
                                       
                                       
                                      \s
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                               0.2 % at 120 days
Detected in NJ Silt Loam Soil (MRID No. 48399927).

Study terminated at 370 days.
                 Anaerobic Soil Metabolism (MRID No. 48399928)
S-2188-OH

5-Amino-4-hydroxy-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                              22.9 % at 252 days
Detected in NJ Silt Loam Soil (MRID No. 48399928).

Study terminated at 364 days.
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                               22 % at 364 days
Detected in NJ Silt Loam Soil (MRID No. 48399928).

Study terminated at 364 days.
MPPZ

5-Amino-4-(o-tolyl)-1,2-dihydropyrazol-3-one
                                      \s
                               0.4 % at 16 days
Detected in NJ Silt Loam Soil (MRID No. 48399928).

Study terminated at 364 days.









                Aerobic Aquatic Metabolism (MRID No. 48399929)
S-2188-OH

5-Amino-4-hydroxy-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                               17.3 % at 30 days
Detected in Calwich Lake Water  -  Silty Clay Loam Seiment (MRID No. 48399929).

Study terminated at 100 days.
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                               23.5 % at 7 days
Detected in Calwich Lake Water  -  Silty Clay Loam Seiment (MRID No. 48399929).

Study terminated at 100 days.
MCNI

2-Cyano-N-isopropyl-2-(o-tolyl)acetamide
                                      \s
                                0.8% at 61 days
Detected in Calwich Lake Water  -  Silty Clay Loam Seiment (MRID No. 48399929).

Study terminated at 100 days.





               Anaerobic Aquatic Metabolism (MRID No. 48399930)
S-2188-OH

5-Amino-4-hydroxy-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                                5.6% at 63 days
Detected in MS Creek Water  -  Clay Sediment (MRID No. 48399930).

Study terminated at 364 days.
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                           90.3 % at 63 and 120 days
Detected in MS Creek Water  -  Clay Sediment (MRID No. 48399930).

Study terminated at 364 days.
Terrestrial Field Dissipation (MRID Nos. 48399931, 48399932, 48399933, and 48399934)
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                               17.0 % at 0 Days

Detected in ID Loam Soil (MRID No. 48399933).

Study terminated at 240 days.


                         Fish BCF (MRID No. 48400005)
S-2188-OH

5-Amino-4-hydroxy-2-isopropyl-4-(o-tolyl)pyrazol-3-one
                                      \s
                                2.7 % at 3 Days
Detected during depuration phase at low dose concentration in edible fish tissue.

Percentage represents portion of total radioactive residue recovered.

Study terminated at 14 days of depuration.
S-2188-DC

5-Amino-2-isopropyl-4-(o-tolyl)-1H-pyrazol-3-one

                                      \s
                               16.2 % at 0 Days
Detected during depuration phase at low dose concentration in edible fish tissue.

Percentage represents portion of total radioactive residue recovered.

Study terminated at 14 days of depuration.

S-2188-DC Conjugate

5-Amino-4-[2-(hydroxymethyl)phenyl]-2-isopropyl-1H-pyrazol-3-one
                                      \s
                               42.0 % at 3 Days
Detected during depuration phase at low dose concentration in edible fish tissue.

Percentage represents portion of total radioactive residue recovered.

Study terminated at 14 days of depuration.


Appendix G.  Toxicity Comparisons of Fenpyrazamine and Transformation Products

The most sensitive toxicity endpoints for aquatic organisms are listed in Table G-1 for the parent compound and any transformation products for which data are available.  For fenpyrazamine, there is toxicity information on three transformation products for acute exposure to daphnia magna (MCNI, S-2188_DC, and S-2188-OH) and for acute exposure to freshwater fish and freshwater green algae there is toxicity information for two transformation products (S-2188-DC and S-2188-OH).  From Table G-1 below, it is noted that parent fenpyrazamine is more toxic on an acute exposure basis to freshwater fish, freshwater invertebrates and freshwater green algae.  In all studies for freshwater invertebrates and fish for all transformation products, the degradate was not toxic up to the highest concentration tested and therefore was at least one order of magnitude less sensitive than parent fenpyrazamine.  Although definitive EC50 values were achieved for the transformation products exposed to freshwater green algae, the data show that parent fenpyrazamine is more toxic to freshwater green algae by at least one order of magnitude.  Therefore, available data on three transformation products to fenpyrazamine exposed to three aquatic taxa show that parent fenpyrazamine is more toxic than its major degradates.

Toxic effects resulting from exposure to chemicals with a similar mode of action are usually a function of the number of molecules and thus it is appropriate to compare toxicity on the basis of molar mass, especially when molecular weight differs substantially (e.g., several fold) between the two compounds (Rand, 2003).  Expressing the endpoints on a parent equivalents basis is essentially equivalent to the expression of the endpoint on a molar basis, it is simply normalized to the parent compound's molecular weight rather than to moles.  Table G-1 shows the results of this analysis and it is noted that the degradates, when expressed on a parent equivalent basis, show to be less toxic than parent fenpyrazamine.  

Table G-1. Toxicity Comparison of Parent Compound and Transformation Products.[A]
                                       
                                 Test Material
                                      MW
                                    (g/mol)
                                 Test Species
                                   Endpoint
               Toxicity Value in mg/L (95% Confidence Interval)
                             Degradate Toxicity  
 Expressed in Parent Compound Equivalents in mg/L (95% Confidence Interval)  B
                                Freshwater Fish
Fenpyrazamine
                                  331.4 g/mol
Rainbow Trout (O. mykiss)
                                  96-hr LC50
                               5.2 (3.8  -  7.8)
                               5.2 (3.8  -  7.8)
S-2188-OH
                                  247.3 g/mol
Rainbow Trout (O. mykiss)
                                       
                                    >97
                                    >130
S-2188-DC
                                  231.3 g/mol
Rainbow Trout (O. mykiss)
                                       
                                    >89
                                    >128
                           Freshwater Invertebrates
Fenpyrazamine
                                  331.4 g/mol
Water flea (Daphnia magna)
                                  48-hr EC50
                               5.5 (4.6  -  6.5)
                               5.5 (4.6  -  6.5)
MCNI
                                  216.3 g/mol
Water flea (Daphnia magna)
                                       
                                    >50
                                   >76.6
S-2188-OH
                                  247.3 g/mol
Water flea (Daphnia magna)
                                       
                                    >98
                                    >131
S-2188-DC
                                  231.3 g/mol
Water flea (Daphnia magna)
                                       
                                    >94
                                    >135
                               Aquatic Plants[C]
Fenpyrazamine
                                  331.4 g/mol
Green alga (P. subcapitata)
                                  96-hr EC50
                             0.16 (0.12  -  0.22)
                             0.16 (0.12  -  0.22)
S-2188-OH
                                  247.3 g/mol
Green alga (P. subcapitata)
                                       
                                49 (41  -  58)
                             65.7 (54.9  -  77.7)
S-2188-DC
                                  231.3 g/mol
Green alga (P. subcapitata)
                                       
                                32 (30  -  35)
                              45.8 (43  -  50.1)
[A] Bold values indicate degradate toxicity that is potentially equivalent to the parent compound (i.e., the toxicity of the parent compound and the degradate are within an order of magnitude or the confidence intervals overlap or both).  
[B] Degradate toxicity in parent compound equivalents (mg/L) = (MW parent/MW degradate) x (toxicity endpoint of degradate (mg/L)).
[C] The most sensitive endpoint for all green algae studies (parent fenpyrazamine and degradate) was cell density.

ECOSAR (v1.0) was used to estimate the toxicity of the transformation products listed in Table G-2 because study data were not available with which to evaluate their toxicity.  ECOSAR predicts toxicity using a regression of the log KOW and measured toxicity endpoints for a particular species and chemical class.  ECOSAR is only used to prioritize the need for additional data on transformation products.  Data on the aliphatic amine, hydrazine, benzyl alcohol, amide, and benzyl nitrile chemical classes were used to estimate toxicity endpoints (see the description of data in the Help section of ECOSAR).  Very limited data sets were available to develop the regressions for the compounds and there is large uncertainty in the estimated values.  However, this is one of the best methods available to estimate ecological toxicity.
 
Table G-2 lists available data for fenpyrazamine and its major degradates alongside of those endpoints predicted by ECOSAR.  For acute exposure, parent fenpyrazamine is generally more toxic by one to several orders of magnitude than ECOSAR predicted endpoints.  In the cases where ECOSAR predicts a more sensitive value than what measured data in a study yielded, it is noted that the uncertainties and limitations associated with structure activity relationship analyses make these predicted endpoints less confident.  This was particularly the case for the hydrazine ECOSAR class where the predicted endpoints would be lower than those results that were determined in a study.  There was only one case where ECOSAR predicted an endpoint where the degradate toxicity was more sensitive than parent fenpyrazamine.  This was the chronic value for fish for the MCNI (amide) degradate with a 0.13 mg/L.  This value, despite being more toxic, is still within an order of magnitude for one of chronic NOAEC available for parent fenpyrazamine, 0.37 mg/L.  The other chronic NOAEC value available for fenpyrazamine was determined to be lower than the lowest concentration tested (<0.039 mg/L).  



Table G-2.  ECOSAR Estimates of Transformation Product Toxicity. [A]
                         Compound (Chemical Class) [C]
                        Estimated Toxicity Value (mg/L)
                                       
                              96-hr FW fish EC50
                             48-hr FW Daphnid LC50
                                  Fish NOAEC
                                 Daphnid NOAEC
                            96-hr EC50 Green Algae
Fenpyrazamine [B]
(Pyrazole)
                                  (5.2, 5.4)
                                     (5.5)
                               (0.37, <0.039)
                                    (0.34)
                                    (0.16)
S-2188-OH
(Aliphatic amine)
                                   (>97)
                                    278.24
                                   (>98)
                                      30
                                     25.71
                                     2.15
                                     (49)
                                     32.58
S-2188-OH
(Hydrazine)
                                   (>97)
                                     5.91
                                   (>98)
                                     7.74
                                    0.44[D]
                                    0.55[D]
                                     (49)
                                     0.11
S-2188-OH
(Benzyl alcohol)
                                   (>97)
                                    845.21
                                   (>98)
                                    610.39
                                   57.95[D]
                                   75.18[D]
                                     (49)
                                    168.50
S-2188-OH
(Amides)
                                   (>97)
                                    856.60
                                   (>98)
                                    297.16
                                     4.00
                                     62.24
                                     (49)
                                     11.67
S-2188-DC
(Aliphatic amine)
                                   (>89)
                                    614.25
                                   (>94)
                                     62.98
                                     70.85
                                     4.23
                                     (32)
                                     78.12
S-2188-DC
(Hydrazines)S-2188DCtc aminehronic ratios (ACRs)thiocarbamate
                                   (>89)
                                     8.78
                                   (>94)
                                     10.12
                                    0.78[D]
                                    0.92[D]
                                     (32)
                                     0.12
S-2188-DC
(Amides)
                                   (>89)
                                  2644.60[E]
                                   (>94)
                                    614.06
                                     10.66
                                    150.50
                                     (32)
                                     20.44
MCNI
(Amides)
                                     16.82
                                   (>50)
                                     20.91
                                     0.13
                                     2.66
                                     1.39
MCNI 
(Benzyl nitriles)
                                     9.10
                                   (>50)
                                     49.08
                                     1.42
                                3.3 x 10[7] [E]
                                     1.58
S-2188-DC conjugate S-2188-CH2OH-DC
(Aliphatic amines)
                                    5773.72
                                    520.75
                                    1167.33
                                     29.67
                                    904.74
S-2188-DC conjugate S-2188-CH2OH-DC
(Hydrazines)
                                     30.15
                                     25.41
                                    4.21[D]
                                    4.32[D]
                                     0.15
S-2188-DC conjugate S-2188-CH2OH-DC
(Benzyl alcohols)
                                   53419[E]
                                   32828[E]
                                   2361.2[D]
                                   2411.9[D]
                                    4130.2
S-2188-DC conjugate S-2188-CH2OH-DC
(Amides)
                                   58097[E]
                                    4882.8
                                    161.32
                                    1781.1
                                    106.81
[A] Toxicity values in parentheses were measured.  All other toxicity values were estimated with ECOSAR (v1.0). 
[B] Toxicity values for the parent compound were not estimated because the transformation products are in a different chemical class and are assumed to have a different mode of action.
[C] Chemical class used by ECOSAR to predict toxicity.
[D] ECOSAR reported this endpoint using acute to chronic ratios (ACRs)
[E] ECOSAR reported the chemical may not be soluble enough to measure this predicted endpoint
 
Rand, G. M. 2003. Aquatic Toxicology (Second ed.). London: Taylor & Francis.

                                       
