### 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**

**Chemical Formula: C**  **17**

# H **21** 

# N **3** 

# O **2** 

# S **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 Sham** **im , 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**2** 

## 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. U SE 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  Es tuarine/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 Anal ysis 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. Ac ute and Chronic Risk to Birds
................................ ................................ ................................ ......... 69 b. Ac ute 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**3** 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 Revie w 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 Fenp yrazamine Transformation Products in Environmental Fate

Studies. Appendix G . Toxicity

Comparisons of Fenpy

razamine and Transformation Products**4** 

## 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 f enpyrazamine.
................................ ................................ .............. 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 use s of fenpyrazamine.
................................ ............ 73**5**



## 1. **E XECUTIVE**  

## S **UMMARY** 

### This ecological risk assessment addresses the new active ingredient f enp yr azamine 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 fenpy razamine are conventional ground and aerial foliar applications on pistachio, bushberry , caneberry , and ginseng crops. Proposed maximum application rates of fenp yrazamine on crops range between 0.375 lbs. a.i./A

– 1.089 lbs. a.i./A with three to four retreatm ent 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 fenp yrazamine (PC Code 090109) with the chemical sy nthesis (IUPAC) name of S
- allyl 5
- amino
- 2,3
- dihydro
- 2
- isopropyl
- 3
- oxo - 4
- (o
- tol yl )py razole
- 1
- carbothiaote. Fenp yr azamine is a py razole fungicide intended to control a number of fungal diseases including brown rot, green fruit ro t/jacket rot, botry

tis bunch rot, lettuce drop, gray mold, and botry

tis blight gray

mold. Fenp yrazamine’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. 1 

### In addition, py

razole 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 organism2 

### . 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 fenp yrazamine and 56.4 percent inert ingredients. Fenp yrazamine 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, fenp yrazamine applications potentially result in dietary

exposure and exposure to plants in the terrestrial environment given its moderate to high persistence in the environment. Fenp yrazamine is moderately persistent in alkal ine aerobic soil with half lives rang ing between 3 8 and 49 days . However, f enp yrazamine degrade s much slower in acidic aerobic soil, with half
- lives between 201

– 801 days . In anaerobic acidic soil environments, half
- liv es are a little less at 128 days. Once reaching the water column, f enp yrazamine is moderately persistent to persistent , especially

in acidic environments, with half
- lives ranging from 12 days – 280 days under aerobic and anaerobic conditions. Fenp yrazamine’s rapid hydrol ys is at pH9 (with a half
life of 12 days) and high stabil ity at pH5 suggests that hydrol ys is may mediate fenp yr azamine’s degradation in the environment. Fenp yr azamine (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

1 Citation: Footprint database. Accessible on
- line: http://sitem.herts.ac.uk/aeru/footprint/en/Reports/2010.htm
.

Accessed June 2012. 2 Citation: Fungicide Resistance Action Committee Classification on Mode of Action 2011. Accessible on
- line:

http://www.frac.info/frac/publication/anhang/FRAC%20MoA%20Poster%202011_final_HR.pdf Accessed August 2012.**6**



### structural activity relationships (ECOSAR v.1.0 ) indicates that fenp yrazamine is at least an order of magnitude or more toxic than these degradates depending on the taxa . Therefore, fenp yrazamine is considered the primary stressor in this risk assessment. Further information related to the justification of fenp yrazamine as the primary stressor is provided in **Section 5.2**  **. 1.2**  **Potential Risks to Non -**  **targ et Organisms**  This is the Environmental Fate and Effects Division’s (EFED) national screening
- level ecological risk assessment for the proposed registration of fenp yrazamine
. A summary of the major conclusions and uncertainties of this assessment for aquatic and terrestrial receptors respectivel y 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 b y restri cted 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 fenp yrazamine. 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 ris k for estuarine/marine fish, ( i.e. , RQ values preceded b y “>” ) the LOC of 1 was exceeded for the proposed use s on ornamentals and ginseng . However there is uncertainty with this and the remaining chronic RQ values for estuarine/marine fish as it is not kn own 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 b y “<” 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 fenp yrazamine. **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 fenpy razamine and to non
- listed LOCs being exceeded for all uses except almonds and pistachios for non
- vascular plants. There were no non
- lis ted or listed LOC exceedances for vascular aquatic plants for all proposed uses of fenp yrazamine. **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 fo r the most sensitive freshwater and**7**



### estuarine/marine benthic invertebrate endpoints (NOAECs of <101 and <3000 μg a.i/kg sediment, respectivel y)
. 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 excee ded the LOC for the ornamental and ginseng use s . 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.

**1.2.2 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 al l proposed uses of fenp yrazamine. 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 indi cated for all proposed uses of fenp yrazamine 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
-b ased 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 EC 25 

### endpoints input into the TerrPlant model for vegetative vigor on account o f 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 EC 25 

### values for seedling emergence (monocot and dicot) were non definitive (>1.54 ad >0.53 for monocots and dicots, respectivel y). Therefore the RQs are not**8**



### 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 fenp yrazamine indicate it is practicall y non - toxic to honey bee on an acute contact and an acute oral basis. While exposure potential exists via pathways such as spr ay drift , limited data available show fenp yrazamine 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 L C 50 

### was determined to be >800 mg a.i/kg dw soil and therefore the data (while limited) suggest fenp yrazamine to be of low toxicity to the earthworm. **1.3 Risk**  **Characterization** In characterizing the risk to terrestrial and aquatic organisms exposed to fenpy raz amine, the largest uncertainties in the currently submitted registrant data is the absence of environmentall yrelevant hydrol ys is 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 b y relativel y 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/m arine fish and freshwater and estuarine/marine sediment invertebrates. Registrant submitted data for these three taxa yi elded non
- definitive ( i.e. “<”) NOAECs and therefore the estimated RQ is only

a lower bound estimate of risk ( i.e
. “>”) . It is an unce rtainty 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 fenp yrazamine a.i. , 5 6 .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 onl y 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 fenp yrazamine range between 0.375 lbs. a.i./A

– 1.089 lbs. a.i./A with three to four treatment s, 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 fenp yrazamine.**9**



### 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** 

**AP PS. and MIN.**  **RETREATMENT INTERVAL**  **SEASONAL APP. RATE**  **(lbs. a.i./A) 5**  **APP LICATION** 

**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 Straw berries 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 Bu shberries 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 appl ications specified on label. 

## 3. **ENVIRONMENTAL FATE**  **AND TRANSPORT**  **CHARACTERIZATION** Physical and chemical properties of fenpy razamine are shown in **Table 2**  below . Environmental fate and transport properties of fenp yrazamine based upon registrant submitted studies or other references are shown in **Table 3**  below. Since fenpy razamine is moderately

mobile and soluble, fenp yrazamine applied to crops has the capability of being translocated to nearb y water bodies via residues dissolving in runoff water. In addition, fenpy razamine may

also sorb to soil and therefore may

reach nearby

water bodies via erosion. Hydrolysis appears to mediate the overall degradation of fenp yrazamine in soil and water as it declines faster in alkaline environments rather than acidic environments.**10**



### Table **2 .**  **Physical and chemical properties of fenpyrazamine. Property**  **Value and units MRID or Source** 

Structure MRID 48399915

Chemical Class Py razole Carboxamide Fungicide http://www.alanwood.net Chemical Formula C 17 H 21 N 3 O 2 S 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·m3 /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 ( Lo w levels of degradation observed)

pH 7: 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 Com plete formation and decline of degradates could not be established**11**



### Table **3 .**  **Summary of fenpyrazamine environmental fate properties.**  **Study /**  **OCSPP Guideline**  **No. Value and unit**  **MRID # or**  **Citation Study Classification,** 

**Comment**

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** Com plete formation and decline of degradates could not be established**12**



### Table **3 .**  **Summary of fenpyrazamine environmental fate properties.**  **Study /**  **OCSPP Guideline**  **No. Value and unit**  **MRID # or**  **Citation Study Classification,** 

**Comment**

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 **Acceptabl e**  **4** pH initial values in study Com plete 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 Com plete 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; K d = 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 % ; pH 5.9

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 13** 



### Table **3 .**  **Summary of fenpyrazamine environmental fate properties.**  **Study /**  **OCSPP Guideline**  **No. Value and unit**  **MRID # or**  **Citation Study Classification,** 

**Comment**

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 Ti ssues 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 8 1.2

– 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.**14** 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 appl ications of fenpy razamine, residues may

be deposited into soil via washoff from rainfall or irrigation activities as well as directl y deposited onto soil during the application. Fenp yrazamine may

reach surface water bodies or ground water giv en its solubi lity of 20.4 mg/L at 20°C (indicating that fenpy razamine is highl y s oluble) (MRID No. 4839 9 915) and Kd 

### values ranging between 0.87

– 8.7 mL/g (indicating that fenpy razamine is slightl y to moderatel y mobile in soil)(MRID Nos. 48399919 and 48399922). 3 

### Itappears that sorption of fenpy razamine is not well correlated to organic carbon content given the weak relationship between soil
- water partition coefficients and organic carbon content collectively among soils. Fenpy

razamine’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, fenp yrazamine residues may also reach surface water bodies via erosion as its range of Kd 

### values suggests that residues may b ind 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 H enry ’s Law Constant of 2.28 x 10 - 10 

### atm·m 3 

### /mol (at 25°C) (EpiSuite HENRYWI N v. 3.20).

 **Degradation of Fenpyrazamine (S -**  **2188) and Identification of Transformation Products in Soil**  Fenp yrazamine appears to be moderatel y persistent in alkaline soil environm ents. Aerobic soil metabolism4 

### 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 fenpy razamine observed in terrestrial field dissipation studies conducted in neutral soils in California (2 sites), Id aho (1 site), and N ew 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). Fenp yr azamine 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) 5 

### In anaerobic acidic soil environments, half
- lives are a little less
3 Kd values determined from seven soils encompassing NJ Silt Loam, CA Loamy Sand soils from MRID No. 48399922 and UK Clay Loam, UK Silt Loam , UK Loam, and UK Loamy Sand, and Japan Sandy Loam from MRID No. 48399919. . No information was provided indicating the representativeness of foreign soils to domestic soils. Please refer to Uncertainties and Limitations section. 4 Alkaline soils in aerobic soil metabolism studies analyzed include UK Sandy Loam Soil (PT
- 102) and UK Loam Soil (SK920191) in MRID No. 48399 920. No information was provided indicating the representativeness of foreign soils to domestic soils. Please refer to Uncertainties and Limitations section. 5 Acidic soils in aerobic soil metabolism studies analyzed include UK Sandy Loam Soil (PT
- 103) and UK Silt Loam Soil (SK1556090) in MRID No. 48399920 as well as NJ Silt Loam Soil in MRID No. 48399927. . No information wa s provided indicating the representativeness of foreign soils to domestic soils. Please refer to Uncertainties and Limitations se ction.**15**



### at 128 days in NJ Silt Loam Soil (MRID No. 48399928). There are no st udies available for anaerobic soil alkaline environments. There are also no field dissipation studies conducted in acidic environments. Soil photoly sis appears to be a minor degradation pathway with a half

- life of 104 day

in NJ Silt Loam Soil (MRID No. 4 8399926). In alkaline aerobic soil metabolism studies (MRI D 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, t heir 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 (MRI D 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 b y large levels of unextracted residues, accounting for approxim ately

up to 70 percent of the material balance in two alkaline soils in aerobic soil metabolism studies (MRID No. 48399920) 5 , 6



### . The identity of the unextracted residues (whether they consist of parent or metabolite residues) is not certain since both pare nt and degradates are moderatel y 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 bodie s will desorb into the water column as demonstrated b y 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 de gradation pathway

for the terrestrial (soil) environment is presented in **Fi gure**  **1** below.

**Figure 1**  **. Proposed degradation**  **and dissipation pathway**  **s in soil.** 

6 Thorough extraction of bound residues was attempted using multiple solvents and repetitions adequately demonstrated that residues became tightly incorporated into soil and sediment particles. **Incorporated Residues**  **to Soil Layer 16** 



###  **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 fenp yrazamine in reservoir surface waters, with a half
- life of 1.64 days (corrected for environmentall y relevant conditions). The degradates **S -**  **2188 -**  **DC** and **MCNI** formed to significant levels of 65.6 and 19.9 percent of the applied, respectivel y. H ydrolysis is also expected to be a key

degradation pathway

particularly

in alkaline environments. However, some degradation is evident in acidic, neutral, and alkal ine 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 hydrol ys is half

- lives of 10.9 days has been determined at pH9. Fenp yr azamine 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. Fenp yrazamine 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, fenpy razamine 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, fenpy razamine is moderatel y persistent with a half

- life of 12.2 days in a Mississippi Creek

–clay sediment s ys tem (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 s ys tem accounted for up to 48.4 percent of the applied . Therefore, the unidentified unextracted residues accounted for in aerobic aquatic metabolism studies for alkaline s ys tems may comprise of additional levels of fenp yrazamine, S
- 2188
- OH, and S
- 2188
- DC degradates. Likewise from soil, it is not expected that th ese 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.**17** 

### Incorporated **Residues to Sediment Layer** 

. 

### Figure **2 .**  **Proposed degradation and dissipation**  **pathway s**  **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 fenp yrazamine residues is low (MRI D No. 48400005) 7 

### . In addition, depuration of fenpyrazamine is negligible and fish tissue metabolism is high, since in the uptake phase, fenp yrazamine is transformed rapidly to S
- 2188
- DC and S
- 2188
- DC conjugate. In the de puration 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 ra pid 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 fenp yrazamine evident in fish and high depuration rates of t he 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 fenp yrazamine which form in soil and water are shown in **Table 4**  below. Fenp yrazamine appears to be less mobile than its degradates as it is less soluble. However, despite this difference , fenpy

razamine and its deg radates all possess solubility values in the same range of

7 BCF study conducted on bluegill sunfish.**18**



### pesticides which both dissolve in runoff water and partition to soils and sediments. Inaddition, the log Koc 

### values of degradates range between 2.20

– 3.67 indicating that they are slightly to moderatel y mobile based on the FAO classif ication scheme. The Kd 

### values of fenp yrazamine 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 fenpy

razamine posse sses mobility characteristics corresponding to the lower end of the range of that encompassing the degradates. Fenpy razamine’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 Fenpyrazam** **ine (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. 1.4 2 ) 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. 1.4 2 ) 3.52 d 0.81 0.23 1.28 2.65 0.38 Soil
- Water Partition Coefficient (Koc ) (KOCWIN v. 2.00) N/Ae 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. 483999 1 4. 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 fenp yrazamine 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 insuf ficient to determine the complete formation and decline rates of the degradates which are needed to complete this anal ys is. This information has not been found upon inspection of open literature nor have data been identified among common degradates from e xisting active ingredients. However, the maximum formations of degradates detected in environmental fate laboratory and field studies can be found in **Appendix F.**
.**19**



###  **Uncertainties and Limitations** There are several significant uncertainties with the environmental fate profile of fenp yrazamine. The first major uncertainty concerns fenp yrazamine’s rate of hydrol ys is in the environment. The existing hydrol ys is study suggest s that fenpy razamine degrades over all environments, especiall y 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 hydrol ys is mediates degradation in alkaline environments
. However, environmentally relevant hydrol ys is data at 25°C were not provided to the Agency for neutral environments (pH7), including the rate of degradati on as well as the levels of the transformation products for fenp yrazamine
. Additional hydrol ys is information would confirm the rate of degradation, as well as the levels of the transformation products of fenp yrazamine at pH7 and 25°C at environmentally

re levant conditions. A second significant uncertainty relates to the limited sediment
- water s ys tems evaluated in the anaerobic aquatic study (MRID No. 48399930). Only one s ys tem was evaluated in each study
. Additional water

– sediment systems would prov ide 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 fenpy razamine 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 fenp yrazamine. 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 l oamy s and soil from California and a s ilt l oam soil from New Jersey (MRID No. 48399922). The remaining soils were evaluated from the UK and Japan (MRID No. 48399919). The UK soils are traditionall y 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 avail able for five other foreign soils in the UK appear to confirm the moderate mobility of fenpy razamine observed in the domestic soils. Additional information on the taxonomic properties of the foreign soils would confirm their representativeness to US soils.**20**



## 4. **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 ef

fects 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 My sid 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 (Pseudokirc h n eriella 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 L OCs are found in **Appendix A.** The designation of “listed species” refers to either federall y threatened or endangered species.**21**



### Table **6 .**  **Toxicity endpoints used in risk quotient calculations .**  **Taxonomic group Representative specie**  **s** Aquatic Animals Ac ute assessment Chronic assessment Lo west tested EC 50 or LC 50 fo r freshwater fish and invertebrates and estuarine/marine fish and invertebrates acute toxicity tests. Lo west no - observed
- adverse
- effects
- concentration (NOAEC) for freshwater fish and invertebrates and estuarine/marine fish and invertebrates early life
- stage tests. Terrestrial Animals Ac ute avian assessment Chronic avian assessment Ac ute mammalian assessment Chronic mammalian assessment Lo west LD 50 (single oral dose) and LC 50 (subacute dietary). Lo west NOAEC for 21
- we ek avian reproduction test. Lo west LD 50 from single oral dose test. Lo west NOAEC for two - generation reproduction test or chronic dietary study Plants Terrestrial non
- listed species Aquatic vascular and algae Terrestrial listed species Lo west EC 25 values from both seedling emergence and vegetative vigor for both monocots and dicots. Lo west EC 50 for both aquatic vascular plants and algae. Lo west EC 05 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 fenpy

razamine 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 o n fres hwater 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 fenp yrazamine 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 fenp yrazamine 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 fenp yrazamine. **4.2 Ecosystems at Risk**  The ecos ys tems at potential risk from the proposed use s of fenp yrazamine are extensive in scope due to the wide geographic distribution of potential fenpy razamine application sites. In general,**22**



### terrestrial ecos ys tems 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 ecos ys tems 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 fenp yrazamine’s moderate persistence and mobility

suggesting its potential to translocate and reside in water bodies. **4.3 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 fenp yr azamine 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 bo th 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). **4.4 Ecological Effects Characterization**  The effects of fenp yr azamine 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. Specificall y, 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 limit ed 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 commonl y tested. In the absence of toxicity data for reptiles and terrestrial phase amphib ians, 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 L C 50 

### and EC 50 

### values or limit of solubility ), mammals (based on LD 50 

### values), avian species (based on LD 50 

### and L C 50 

### values), and non
- target insects (base d on LD 50 

### values for honey bees) (U.S. EPA 2001).**23** 

### 4.4.1 **Aquatic Effects** The acute and chronic toxicity values associated with freshwater and estuarine/marine species exposure to fenp yrazamine 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 fenpy razamine’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 fenp yrazamine are summarized in **Table 8** 
.
**Table 7**  **. Toxicity**  **r eference**  **v alues**  **f or**  **a quatic**  **o rganisms**  **e xposed to**  **f enpyrazamine**  **. 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 **LC 50**  **= 5.2 m g**  **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 LC 50 = 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)**24**



### Table **7 .**  **Toxicity r**  **eference v**  **alues f**  **or a**  **quatic o**  **rganisms e**  **xposed to f**  **enpyrazamine .**  **Exposure Scenario**  **%**

**A.I. Species**  **Dur. Toxicity**  **Reference Value**  **(95% CL) Effect Notes**  **MRID; Classifi** **** **cation (Year)** 

**Chronic** TGAI

94.7% Rainbow Trout (Oncorhynchus mykiss) 90 d **NOAEC (survival at**  **hatch, survival at test**  **termination) = 370 μg a.i./L**  LOAEC = 750 μg 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 **EC 50**  **= 5.5 m g**  **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)**25**



### Table **7 .**  **Toxicity r**  **eference v**  **alues f**  **or a**  **quatic o**  **rganisms e**  **xposed to f**  **enpyrazamine .**  **Exposure Scenario**  **%**

**A.I. Species**  **Dur. Toxicity**  **Reference Value**  **(95% CL) Effect Notes**  **MRID; Classifi** **** **cation (Year)** 

**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 c oncentrations (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 variegat us ) 96 h **LC 50**  **: >3.9 m g**  **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)**26**



### Table **7 .**  **Toxicity r**  **eference v**  **alues f**  **or a**  **quatic o**  **rganisms e**  **xposed to f**  **enpyrazamine .**  **Exposure Scenario**  **%**

**A.I. Species**  **Dur. Toxicity**  **Reference Value**  **(95% CL) Effect Notes**  **MRID; Classifi** **** **cation (Year)**  **Chronic** TGAI

98.8% Sheepshead minnow ( Cyprinodon variegat us ) 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 LC 50 = 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 ( Crasso s trea virginica ) 96 h **EC 50**  **= 0.78 m g**  **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)**27**



### Table **7 .**  **Toxicity r**  **eference v**  **alues f**  **or a**  **quatic o**  **rganisms e**  **xposed to f**  **enpyrazamine .**  **Exposure Scenario**  **%**

**A.I. Species**  **Dur. Toxicity**  **Reference Value**  **(95% CL) Effect Notes**  **MRID; Classifi** **** **cation (Year)** 

**Chronic** TGAI

98.8% Saltwater mysid ( Americamysis bahia) 38 d **NOAEC = 98 μ**  **g a.i./L**  LOAEC 50 = > 98 μg a.i./L  Mysids exposed to control, 3.2,

6.8, 13, 24, 47, and 98 μg 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  Gro wth 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)**28**



### Table **7 .**  **Toxicity r**  **eference v**  **alues f**  **or a**  **quatic o**  **rganisms e**  **xposed to f**  **enpyrazamine .**  **Exposure Scenario**  **%**

**A.I. Species**  **Dur. Toxicity**  **Reference Value**  **(95% CL) Effect Notes**  **MRID; Classifi** **** **cation (Year)**  TGAI 94.7 Freshwater midge (Chironomus riparius) 28 d Sediment value: NOAEC (development rate) = **< 0.101 μ**  **g a .**  **i/kg dw** Pore water value : NOAEC (development rate) = **<0.20 μ**  **g 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**  TGAI

98.8% Saltwater amphipod (Leptocheirus plumulosus) 28 d Sediment value: NOAEC/LOAEC **= <3.0/6.3 m g**  **a .**  **i/k g dw (** dry weight) Pore water value : NOAEC/LOAEC **= <**  **0.25/0.5 m g**  **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 **EC 50**  **(frond weight): 1.1 m** **g 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 frond s. 48400018 Acceptable (2010)**29**



### Table **7 .**  **Toxicity r**  **eference v**  **alues f**  **or a**  **quatic o**  **rganisms e**  **xposed to f**  **enpyrazamine .**  **Exposure Scenario**  **%**

**A.I. Species**  **Dur. Toxicity**  **Reference Value**  **(95% CL) Effect Notes**  **MRID; Classifi** **** **cation (Year)** 

**Algal toxicity**  TGAI

98.8% Cyanobacteria ( Anabaena flos
- aquae) 96 h EC 50 (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 EC 50 (cell density): 0.16 mg a.i/L (0.12

– 0.22) NOAEC (cell density): <0.053 mg a.i/L EC 05 (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 EC 50 (cell density): 0.027 mg a.i/L (0.024

– 0.035) NOAEC (cell density): <0.0045 mg a.i/L EC 05 : 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 **EC 50**  **: (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 EC 05 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.**30**



### 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 EC 50 : >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 EC 50 : >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 EC 50 : >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 LC 50 : > 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)**31**



### 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)**  S
- 2188
- OH TGAI

98.4% Rainbow trout ( Oncorhynchos mykiss ) 96 h LC 50 : > 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 EC 50 (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 EC 50 (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 fenpy razamine were available for 2 species of freshwater fish: rainbow trout and bluegill sunfish. All studi es were conducted on TGAI with 94.7 % purity . In the rainbow trout study (MRID 48399945), fenp yrazamine was administered in a flow
- through exposure system and caused 100% mortality at the highest treatment conc entration (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, respectivel y. In the bluegill sunfish study (MRID 48399944), TGAI fenpy razamine was administered in a flow through s ys tem. The two highest treatment concentrations (6.9 and 12 mg a.i/L , mean measured) had 85 and 100 % mortality , respectivel y 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 equil ibrium after three hours of exposure and were dead by six hours. This**32**



### study has an LC 50 

### 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 acu**  **te risk quotients for freshwater fish.**  There were two additional acute freshwater fish toxicity studies submitted with degradation products of fenp yrazamine. 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 LC 50 

### 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 L 50 

### of >89 mg a.i/Land is classified as acceptable. An acceptable chronic early life stage test with a freshwater fish (rainbow trout, MRID 48400003) was conducted with TGAI fenp yrazamine (94.7% purity). Fertilized egg/embryos were exposed at mean measured concentrations of 50, 100, 190, 3 70, and 750 μg 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, respectivel y. On day

30 of the study

(Day 0, post
- hatch) larval survival was significantl y reduced (p<0.05) at the highest treatment concentration. On day 90 of the study

(Day 60, post
hatch) larval survival was also significantl y reduced (p<0.05) onl y 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 signifi cant reductions (p<0.05) as compared to the negative control. The NOAEC and LOAEC for this study was determined to be 370 and 750 μg a.i/L , respectivel y based on effects to Day
- 0 post hatch larval survival and Day
- 60 post hatch larval survival. **F or risk**  **assessment purposes, a chronic**  **toxicity of 370**  **μg a. i/L will be used for**  **estimating chronic**  **risk quotients for freshwater**  **fish .** 
 **Freshwater Invertebrates** An acute toxicity

study conducted with TGAI fenpy razamine (94.7%) on freshwater invertebrates was available for Daphnia magna . A 48
- h EC 50 

### of 5.5 mg a.i/Lwas 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 concentrati on (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. **Fo r 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 fenpy razamine. All studies were conducted with the Daphnia magna
.**33**



### In one study

conduct ed 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 EC 50 

### 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 EC 50 

### determined to be >94 mg a.i/L . Finall y, 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/Lwhich represents the limit of solubility for this degradate. There were no mortalities or sublethal effects observed during the study and therefore the EC 50 

### was determined to be >50 mg a.i/L . All studies were classified as acceptable. A freshwater invertebrate ( Daphnia magna ) lifecycle test with fenp yrazamine TGAI ( 94.7 %) was submitted and found to be acceptable (MRID 484 00001 ). Daphnids were exposed throughout their life cycle to mean measured concentrations of fenp yrazamine 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 significantl y reduced (p<0.05) at the two highest treatment concentrations (0.76 and 1.4 mg a.i/L, mean measured) as comp ared to the negative control. The number of immobilized offspring, if any , was not reported. At study termination, m e an total body lengths of surviving daphnia were significantl y reduced (p<0.05) compared to the negative control at the two highest treatm ent concentrations. Mean dry weights of surviving daphnia were onl y 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 b y 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 NOAE C and LOAEC values of 0.34 and 0.76, respectivel y. **Fo r 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 fenp yrazamine (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/Llevel, 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 LC 50 

### for this study was determined to be >3.9 mg a.i/Land 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). 34** 



### An estuarine/marine chronic fish earl y life stage test conducted with fenp yrazamine TGAI (98.8%) on the sheepshe ad 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 fenpy razamine 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 significantl y reduced from the negative control (p<0.05) at all tre atment levels. Dry weights were significantl y 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 o ys ter ( Crassotrea virginica ; MRID 48399940, both conducted with TGAI fenpy razamine (98.8% purity) . With mysids, a 96
- h LC 50 

### 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 m easured). With the eastern oyster, a 96
- h EC 50 

### 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 , respectivel y (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 invertebra tes.**  An estuarine/marine invertebrate ( Americamysis bahia ) lifecycle test with fenpy razamine TGAI ( 98.8 %) was submitted and found to be acceptable (MRID 48400002 ). Mysids were exposed throughout their life cycle to mean measured concentrations of fenp yrazamine ranging from 3.2

– 98 μg a.i/L for 2 8 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 2 8 days was also not significantl y 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 significantl y reduced from the ne gative control. For female total body l ength, statistical hypothesis testing determined a significant effect (p<0.05) at the 3.2, 47, and 98 μg 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**35**



### not follow a dose responsive pattern, it was determined that the NOAEC for this endpoint was the highest treatment concentration (98 μg 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 μg a.i/L, respectivel y. **F or risk assessment purposes, a chronic**  **toxicity value of 98**  **μ g a.i/L will be**  **used for estimating chronic**  **risk quotients for estuarine/marine invertebrates**  **( i.e.**  **, a lower bound of**  **98 μ**  **g a.i/L will be assumed as a screen for chronic**  **effects).**

 **Benthic (Sediment Dwelling) Invertebrates** Effects of fenp yr azamine 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 Hya lella study , 8 day old amphipods were exposed to spiked sediment concentrations that were time weighted averaged to yi eld 5.7, 1 0, 24, 38, and 97 mg a.i/L . On Day 28, survival was statistically

significant (p<0.0 5 ) in the three highest treatment concentrations when compared to the negative control. These treatment concentrations were excluded from the Day 28 dry weight anal ys is and there were no significant reductions from the negative control in the two lowest treatment concentrations. On Day 35, survival was significantl y 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 anal ys is 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 , respectivel y 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 μg a.i/kg sediment for midge vs. 5700 μ g a . i
. /kg sediment for amphipod). This lower NOAEC likely reflects a combination of factors including interspecies differences in sensitivity to fenpy razamine and measurement of additional endpoints ( e.g. , development rate). It is important to note, however, that this study involved exposure via the overl ying water and concentrations varied considerabl y over time. Specifi cally , both pore water and sediment concentrations increased dramaticall y from day 0 to day 28, while overlying water concentrations decreased, thus reflecting the expected partitioning of fenp yrazamine to sediments from the water column. Freshwater midge s were exposed to time weighted averaged sediment concentrations of 101, 215, 326, 611, and 790 μg a.i/kg dw sediment. Percent emergence was significantl y 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**36**



### is preferred. O C SPP 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 th at a definitive NOAEC was not achieved for the most sensitive endpoint of this study
. **Fo r**  **risk assessment purposes, a toxicity value of 101**  **μ g**  **a .**  **i/L will be used for estimating chronic risk quotients for freshwater**  **benthic invertebrates in the sediment an d 20**  **μ g a.i/L for**  **freshwater benthic invertebrates in the pore water (i.e., an upper bound of**  **101 μ**  **g a.i/ kg dw**  **sediment and 20**  **μ g a.i/L**  **will be assumed as a screen for chronic effects).** The effects of fenp yrazamine 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 significantl y reduced (p< 0.05) at the two highest treatment concentrations as compared to the negative control. The number of offspring per female was significantl y 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 anal ys is 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
. **Fo r risk**  **assessment purposes, a toxicity value of 3**  **m g**  **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 w ater**  **(i.e., an upper bound of**  **3 m g 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 484000 18 ) was submitted along with three non - vascular aquatic plant studies (algae) were submitted conducted with TGAI fenp yrazamine (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 day s 0 to 7 growth rate. Fro nds 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 sensitiv e endpoint for this study

was frond weight with a 96
- h EC 50 

### and NOAEC value of 1.1 and 0.060 mg a.i/L , respectivel y. This study is classified as acceptable. **Fo r 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**37**



### fenp yrazamine (94.7

– 98.8% % puri ty). In one study conducted with freshwater green algae ( Pseudokirchneriella subcapitata, MRID 48400021), fenp yrazamine was exposed to cultures ranging from 0.053 to 0.90 mg a.i/L, mean measured concentrations. The percent growth inhibition in the treate d 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 EC 50 

### and NOAEC values of 0.16 and <0.053 mg a.i/L , respectivel y. As the NOAEC for this endpoint was non
- definitive, EFED policy is use the EC 05 

### 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 fenp yrazamine was exposed in mean measured concentrations of 0.0045, 0.011, 0.028, 0.18, 0.42, and 1.2 mg a.i/Lto 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 EC 50 

### 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 EC 05 

### 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 fenp yrazamine 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. C ells in the negative control group and all treatment concentrations appeared normal throughout the duration of the test. The 96
- h EC 50 

### and NOAEC values form this test (based on cell density) are 0.011 and 0.0049 mg a.i/L , respectivel y. A study conducte d with TGAI fenpy razamine 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 EC 50 

### and NOAEC values (based on cel l 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 u sed to assess risk to listed aquatic non**  **- vascular plants**  **.** Additionally , two acceptable aquatic non
- vascular plant toxicity studies were submitted with degradation products of fenpy razamine. Both studies were acceptable and exposed degradation product s 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 th e treated algal culture as compared to the negative control ranged from 1.1 to 89.3 % based on cell density , 0.3**38**



### 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 EC 50 

### 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 fenpy razamine 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 EC 50 

### and NOAEC values based on cell density were 55 and 3.1 mg a.i/L, respectivel y.

**4.4.2 Terrestrial Effects**  All toxicity

reference values used to assess the potential acute and chronic risks of fenp yrazamine exposure to birds and mammals were obtained from acceptable or supplemental studies using fenp yr azamine 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 **LD 50**  **>2000 m g a**  **. i/k** **g 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 **LC 50**  **>4430 m g a**  **. i/k** **g 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 LD 50 >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)**39**



### 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** TGAI 94.7% Bobwhite Quail Colinus virginianus (Subacute Dietary) 8 d LC 50 : >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 NOAE C =517 mg a . i/kg diet LOAE C =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 hi ghest tested) was significantly reduced (p<0.05) from the control) 48400013 Acceptable (2008)

TGAI 94.7% Bobwhite Quail Colinus virginianus 24

wk **NOAEC= 248 m g**  **a .**  **i/k g diet**  LOAE C =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)

**Mam mals** 

**Acute** TGAI

94.8 % Rat

(Rattus norvegicus) 14 d **LD 50**  **>2000 m g ai/k** **g 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)**40**



### 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 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, numb er 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 signif

icant 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 LD 50 : > 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 μg 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 LD 50 : > 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 μg a.i/bee  Mortality in negative and solvent controls was 0%. 48399935 Supplemental (2006)**41**



### 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 Other Non**  **- target Terrestrial Organisms** 

**Acute** TGAI

94.7% Earthworm (Eisenia fetida ) 14 d LC 50 : >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 re duced (p<0.05) at all but lowest concentration 48400025 Supplemental (2006)
**Terrestrial Plant**

**Seedling em**  **ergence** TEP

44.4% Multiple

species 21 d **Most sensitive**

**monocot: corn EC**  **25 (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**  **EC 25**  **(w eight): >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** EC 25 : Could not be determined due to lack of toxicity NOAEC: 0.56 lbs a.i/A

----------------------- **Most sensitive dicot** EC 25 : 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.**42** 

###  **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 fenpy razamine is practically

non - toxic to these species of birds on an acute exposure basis. The acute oral LD 50 

### values are > 2000 mg a . i/kg bw for both the northern bobwhite quail and canary studies (MRIDs 48400009 and 48400010, respectivel y) 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 regurgitati on. All three acute oral studies are classified as acceptable. **Fo r risk assessment purposes, an acute oral LD**  **50** 

### 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 m**  **g a**  **. i/kg bw will be assumed as a screen for**  **acute effects).** There were two subacute studies submitted f or the northern bobwhite quail and mallard duck (MRIDs 48400011 and 48400012, respectivel y). In the northern bobwhite quail study , TGAI fenp yrazamine 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 sign s 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 ef fects on food consumption noted. The resultant L C 50 

### for the study was >5039 mg a.i/kg
- diet and this study was classified as acceptable. For the mallard duck study , TGAI fenpy razamine 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 si gns of toxicity noted durin g 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 LC 50 

### for this study was >4 4 30 mg a.i/kg
- diet and this study is classified as acceptable. **F or risk assessment purposes, a subacute dietary**  **LC 50**  

### of > **4430 ppm in the diet) will be used qualitatively to evaluate potential acute effects**  **to birds ( i.e.**  **, a lower bound o f**  **4430 ppm will be assumed as a screen for acute effects).** 

 **Birds (Chronic Toxicity)** Two studies were submitted that examined the chronic toxicity of fenpy razamine 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 TGAIfenp yrazamine (94 .7%i). There was a single**43**



### adult mortality

observed during the tes t from the control group that was found dead approximately

19 weeks post treatment. There were no overt clinical sign s of toxicity observed at any of the treatment concentrations nor were there any treatment related effects on adult body weight or food co nsumption. 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 fai lure 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 w ere 519 and 1022 mg a.i/kg
- diet, respectivel y 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 2 8 week old quail (4 groups of 18 replicate pairs/ group including control) app roaching their first breeding season a diet containing mean measured concentrations of 248, 495, and 978 mg a.i/kg
- diet of TGAI fenp yrazamine (9 4.7%)
. 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 h atchling 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 staticall y 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, respectivel y, based on 14
- day survivor body weight and the study is classified as acceptable. **The dietary chronic N**  **OAEL of 248 ppm will be used in estimating chro**  **nic 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 fenp yrazamine (94.8%) at a single treatment concentration. There were no m ortalities observed during the study along with no treatment related effects on body weight or clinical signs of toxicity . The LD 50 

### was therefore determined to be >2000 mg a.i/kg
bw which categorizes fenpy razamine as practicall y non - toxic to mammals on an acute oral basis. This study

is classified as acceptable. **An acute oral LD 50**  

### 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 fenp yrazamine (MRID 48400127). TGAI (94.7%) fenpy razamine 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 thy roid weight and histological findings in these organs (cell hy pertrophy) and reduced food consumption and decreased body weight gain throughout the**44**



### 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 s ys temic toxicity in maternal animals (body weight gain loss, body weight reduction, thy roid enlargement , hepatocellular and thy roid cell hy pertrophy). Fenpy

razamine 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 significantl y decreased number o f 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 ma**  **mmals.**

 **Non -**  **target Beneficial Insects** Two studies were submitted that examined the acute toxicity of fenpy razamine to the honey

bee ( Apis mellifera ). The first study , examined acute oral exposure of bees to fenpy razamine (94.7 % a .i) for 48 hours (MRID 48399935 ). The bees were exposed to nomin al doses of 6.3, 13, 2 5 , 50, and 100 μ g 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 LD 50 

### of > 100 μg a . i/bee. At test termination, a single bee in the 25 μ g 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 fenp yrazamine (94.7%) in an acute contact design that included nominal concentrations of 1.9, 4.3, 9.4, 21, 45, and 100 μ g a.i/bee. After 48 hours, there was a m aximum 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 patter

n. The LD 50 

### for this study was determined to be >100 μ g a.i/bee and the study is classified as acceptable.

 **Other Non -**  **target Terrestrial Organisms** An acute toxicity

study was submitted that exposed TGAI fenpy razamine 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 c oncentration. 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 L C 50 

### was determined to be >800 mg a.i/kg dw soil. This study was scientificall y sound but i s not designed to fulfill any current OCSPP guideline requirement and is therefore classified as supplemental.**45** 

###  **Terrestrial Plants** A seedling emergence and vegetative vigor study were submitted with TEP fenp yrazamine (44.4% a.i) (MRIDs 48400016 and 48400017, respectivel y). 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 EC 25 

### 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 fenp yrazamine 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. Phyt otoxic effects in this study included necrosis, stem curl, and unshed curl. Phy totoxicity 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 phyt oxicity signs. The most sensitive monocot NOAEC, L OAEC and EC 25 

### was 0.15, 0.30, and >0 .60 lbs a.i/A based on survival. The most sensitive dicot NOAEC, LOAEC, and EC 25 

### 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 EC 05 

### in its place for estimation of RQs. However, despite the model converging, an EC 05 

### 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 fenpy razamine (MRID 48400017), plants were exposed to mean measured concentrations of fenpy razamine 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%. Phy totoxic 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 . Phy totoxic 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, L OAEC and EC 25 

### 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**46**



### 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. **Fo r 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 ris**  **k 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**  Fenp yrazamine is formulated as a suspension concentrate for foliar ground and aerial spray and for spray chemigation. The rate of application for fenp yrazamine 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 interv al between application of 7 days for all uses . Fenp yrazamine , a fungicide, belongs to the py razole carboxamide class of fungicides
. Other members of this family of pesticides include penthiopy rad, penflufen, and sedaxane. Fenp yrazamine’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 myc elium elongation. 8 

### Inaddition, py razole fungicides are known to inhibit the succinate
- dehydrogenase enzyme which serv es a critical mechanism as part of the citric acid cycle and providing a pathway for electronic transfer throughout the organism
. 9 

### 5.1 **Risk Hypotheses** Risk hy potheses 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 fenpy razamine , the following ecological risk hy pothesis is being employed for this risk assessment: Given the proposed ground and aerial foliar spray uses of fenp yrazamine 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, fenp yrazamine results in potential adverse effects upon the survival, growth, and reproduction of non
- target terrestrial and aquatic organisms.

8 Citation : Footprint database. Accessible on
- line: http://sitem.herts.ac.uk/aeru/footprint/en/Reports/2010.htm
.

Accessed June 2012. 9 Citation: Fungicide Resistance Action Committee Cla ssification on Mode of Action 2011. Accessible on
- line:

http://www.frac.info/frac/publication/anhang/FRAC%20MoA%20Poster%202011_final_HR.pdf Accessed August 2012.**47**



### 5.2 **Conceptual Model** For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically signifi cant 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 c omprehensive toxicity

data for freshwater fish, freshwater invertebrates, an d aquatic plants indicate that fenp yr azamine is more toxic than the degradates S
- 2188
- OH and S
- 2188
- DC at magnitudes surpa ssing an order of magnitude. Furthermore, ECOSAR indicates that fenp yrazamine 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 fenpy razamine for green algae . However, no exposure of green algae to the S
- 2188
- DC conjugate is expect ed since the S
- 2188
- DC conjugate is only found to bioconcentrate in fish tissue. A summary of the measured and estimated endpoints comparing fenp yrazamine and the degradates can be found in **Appendix G** 
. **The environmental fate properties of fenpyrazamine**  **i ndicate 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 fenp yrazamine sprays, runoff, leaching, and spray drif t 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 fenp yrazamine exposure. Terrestrial animals may be exposed to fenpy

razamine by

intentionall y or inadvertently ingesting residues on treated crops
. They also may be exposed by

other routes, such a s by

walking on residues or drinking water contaminated b y residues . Based on the nature of fenp yrazamine applications, as well as fenp yrazamine’s moderate persistence and mobility in the environment, dietary exposure to terrestrial exposure and aquatic exposure from fenpy razamine applications will be assessed. Furthermore, given fenpy razamine’s tendency

to bind to soil and sediment (as evidenced b y 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 fenp yrazamine’s high Kow value and expected bioconcentration, s teady
- state BCF values in fish are low (MRID No. 48400005) 10 

### . In addition, fenp yrazamine 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.

10 BCF study conducted on bluegill sunfish.**48**



### Drinking water and inhalation exposure to terrestria **l 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), respectivel y. SIP is available publicall y 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. **5.3 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 LD 50 

### or NOAEC. The RQ is calculated as a ratio of the estimated environmental concentration (EEC) to an effect level ( e . g. , LC 50 

### , LD 50 

### 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 excee ds 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 presump tions, 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 fenp yraz amine, the available ecological effects data is d etermined 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 fenp yrazamine in this assessment are obtained from modeling efforts onl y, 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 fenpy razamine 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 1**  and will be estimated for each use of fenp yrazamine . 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**49**



### Modeling S ys tem (PRZM/EXAMS) publically available at: http://www.epa.gov/oppefed1/models/water/p e5_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) publicall y 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 f ate 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) ).

**5.3.2 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 ty pically used in risk assessments include changes in survival, reproduction, or growth as deter mined 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 ecos ys tems. 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 LD 50 

### , L C 50 

### , or EC 50 

### ) 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 typicall y 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.

**5.3.3 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 respo nse of these receptors to fenp yrazamine 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 ecos ys tems selected for modeling using PRZM/EXAMS aquatic assessment and T
- REX for the terrestrial animal assessment are intended to be generall y representative of any aquatic or**50**



### terrestrial ecos ys tem associated with areas where fenpy razamine is used. The receptors addressed b y the aquatic and terrestrial risk assessments for fenp yrazamine 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. 

## 6. **EXPOSURE ANALYSIS**  **6.1 Aquatic Exposure**  Tier II Estimated Environmental Concentrations (EECs) were estimated using EFED’s aquatic models PRZM (P esticide Root Z one M odel) version 3.12 (dated May 2005 ) and EXAMS ( Exposure Analysis M odeling S ys tem) 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
- m2 

### 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 justification s . **Table 10**  **. Summary of**  **PRZ M/EXAMS input parameter values for physical chemical and fate**  **properties used for**  **fenpyrazam ine surface water aquatic EECs.**  **PRZ M/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·m3 /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 (t 1/2 ) pH4: Stable pH7: Stable pH9: 10.9 days MRID No. 48399923 Conservative default for pH7 2**51**

**Table 10**  **. Summary of**  **PRZ M/EXAMS input parameter values for physical chemical and fate**  **properties used for**  **fenpyrazam ine surface water aquatic EECs.**  **PRZ M/EXAMS**  **Input Parameter Input Value and Unit**  **Source** Aqueous Photolysis (t 1/2 ) 1.64 days MRID 48399924 Aerobic soil metabolism (t 1/2 ) 478.09 days MRID 48399919 3 MRID 48399928 4 Aerobic aquatic metabolism (t 1/2 ) 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 (t 1/2 ) 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: t 1/2 input = / + (t 90, n
- 1 x σ ) n 1/2 where / is the mean of the set of half lives from each study, t 90, n
- 1 is the one
- sided t value for the 90 th percentile level, σ i s 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 o n the label for fenp yr azamine 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 th e 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 MIAsparagus crop scenarios were used as a surrogate to represent fenpy razamin e 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**  **. 52** 



### Table **11 .**  **Crop management PRZM/EXAMS inputs used in aquatic exposure modeling.**  **PRZ M/EXAMS**  **Input Parameter Input Value and Unit**  **Comment** Labeled Crop, Crop Scenarios, Application Rate, Number of Applications, Retreatment Time Interval, and Application Date **Alm onds 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 d ate 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**53**



### Table **11 .**  **Crop management PRZM/EXAMS inputs used in aquatic exposure modeling.**  **PRZ M/EXAMS**  **Input Parameter Input Value and Unit**  **Comment**

**Ornam entals**  **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 ye ar upper bound EECs for all scenarios are presented in **Table 12**  **and Table**  **13** f

or aerial and ground applications, respectively
. Examples of the PRZM/EXAMS input and output files are in **Appendix E** 
. A s expected, EECs from aerial applications are higher than ground applications with peak acute EECs ranging between 10.21

– 86.60 μg /L , 21
- day EECs ranging between 9.80

– 83.92 μg/L, and 60
- day chronic average EECs ranging between 9.23

– 80.35 μg/L amongst all of the crop scenarios. For ground applications, EECs are generall y slightly lower than aerial applications with peak acute EECs ranging between 7.41

– 81.22 μg /L , 21
- day

EECs ranging between 7.3 4

– 78.70 μg/L, and 60
- day chronic average EECs ranged from 6.88

– 75.18 μg/L. It is important to note that concentrations of fenp yrazamine 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 ye ar upper bound b enthic pore water EECs from PRZM/EXAMS for all scenarios are presented in **Table 14**  **and Table**  **15** for aerial and ground applications, respectivel y. Fenp yrazamine EECs in benthic water pores were generall y half of the values in surface water. For aerial applications, peak acute EECs range between 5.92

– 47.17 μg /L , 21
- day EECs rang e between 5.26

– 46 .79 μg/L , and 60
- day chronic average EECs range between 5.15

– 46.05 μg/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

–**54**



### 44.27 μg /L , 21
- day

EECs ranging between 3.93

– 43.92 μg/L, and 60
- day chronic average EECs ranged from 3.86

– 43.23 μg/L. The modeling results for benthic water pores also do not change significantl y with time. Please refer to **Section 7.2.6**  **.b** f or further details related to a further characterization of th ese result s and the uncertainties accounted for which contribute to this result. One
- in
- ten ye ar 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 significantl y 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 fenp yrazamine’s tendency to adsorb to soil and sediment given its moderate Koc 

### values. Furthermore, EXAMS assume s 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 o ver time. **Table 12**  **. PRZM/EXAMS estimated one**  **- in**  **- ten year upper bound concentrations in**  **surface water (ppb) for aerial applications**  **of fenpyrazamine. Crops**  **PRZ M 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
Straw berries FL Straw berry 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.**55**



### Table **13 .**  **PRZM/EXAMS estimated one -**  **in -**  **ten year upper bound concentrations in surface water (ppb) for**  **ground applications of fenpyrazamine.**  **Crops PRZ** **M 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
Straw berries FL Straw berry 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 PRZ** **M 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
Straw berries FL Straw berry 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.**56**



### Table **15 .**  **PRZM/EXAMS estimated one -**  **in -**  **ten year upper bound concentrations in benthic pore water (ppb) for**  **ground applications of fenpyrazamine.**  **Crops PRZ** **M 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
Straw berries FL Straw berry 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 PRZ** **M 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
Straw berries FL Straw berry 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.**57**



### 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**  **PRZ M 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
Straw berries FL Straw berry 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 fenp yrazamine 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 fenp yr azamine.

**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) m odifications 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 e stimate EECs. **Table 18**  **and Table**  **19** show the estimated environmental concentrations (EECs) for the three weight classes of birds and mammals, respectivel y .**58**



### Table **18 .**  **Terrestrial f** 

**ood i** **tem r**  **esidue e**  **stim ates for**  **b irds with**  **p roposed**  **f enpyrazamine**  **u ses on**  **v arious**  **c rops**  **. 20**  **- gram**  **bird 100**  **- gram** 

**bird 1000**  **- gram** 

**bird All weight classes** 

**(bird )**  **Proposed use Food Item**  **Maximum Dose -**  **Based EECs (m g/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 Straw berries 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 f** 

**ood i** **tem r**  **esidue e**  **stimates for m**  **ammals with p**  **roposed f**  **enpyrazamine u**  **ses on v**  **arious c**  **rops .**  **15 -**  **gram ma**  **mmal 35**  **- gram** 

**ma mmal**  **1000 -**  **gram**

**ma mmals**  **All weight classes**

**(m ammal** **) Proposed use**  **Food Item Maximum Dose**  **- Based EECs (m**  **g/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**59**



### Table **19 .**  **Terrestrial f** 

**ood i** **tem r**  **esidue e**  **stimates for m**  **ammals with p**  **roposed f**  **enpyrazamine u**  **ses on v**  **arious c**  **rops .**  **15 -**  **gram ma**  **mmal 35**  **- gram** 

**ma mmal**  **1000 -**  **gram**

**ma mmals**  **All weight classes**

**(m ammal** **) Proposed use**  **Food Item Maximum Dose**  **- Based EECs (m**  **g/kg -**  **bw) Dietary**  **- based**  **EEC (ppm)** 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 Straw berries 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 fenp yrazamine. **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, 0.49 Runoff to Dry areas 0.01**60**



### 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**  Caneberries, Strawberries, Ginseng 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 

## 7. **RISK CHARACTERIZATION**  Risk characterization is the integration of exposure and effects characterization to determine the ecological risk from the use of fenp yrazamine and the likelihood of effects on aquatic life, wildlife, and plants based on varyingpesticide
- use scenarios. The risk characterization provides estimation and a description of the risk; articulates risk assessment assumptions, limitations, and uncertainties; s ynthesizes 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 fenp yrazamine 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 anal yz e 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 fenpy

razamine to non - t arget aquatic animals and plants, surface water, pore water and sediment EECs for fenp yrazamine were obtained from the Tier 2 model PRZM/EXAMS based on the label
- recommended usage scenarios **Table 3** **61** 

### 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 L C 50 

### of >3900 μg 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 giv en application method on a given crop. For example, a peak EEC of 30 μg a.i/L and a 96
- hr LC 50 

### of >3900 μg a.i/L would yi eld 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 . Conversel y, for chronic exposure to estuarine/marine fish, a NOAEC value was determined to be <39 μg 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 μg a.i/L and a NOAEC value of <39 μg a.i/Lwould 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 al l 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 ,**  **S ection**  **7.2.1 .** **62**



### 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 (μg**  **a.i./L) EEC** 

**60 -**  **Day (μg**  **a.i./L) LC**  **50**

**(μg a.i./L)**  **NOAEC**

**(μg a.i./L)**  **Acute RQ**

**(Peak EEC/LC**  **50 )**  **Chronic**

**RQ (60**  **- day**  **EEC/NOAEC)** Al monds (CA Al mond) 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 Al mond) 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**63**



### 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 (μg**  **a.i./L) EEC** 

**60 -**  **Day (μg**  **a.i./L) LC**  **50**

**(μg a.i./L)**  **NOAEC**

**(μg a.i./L)**  **Acute RQ**

**(Peak EEC/LC**  **50 )**  **Chronic**

**RQ (60**  **- day**  **EEC/NOAEC) 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 we ll 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 m aximum 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 ,**  **S ection**  **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 (μg**  **a.i./L) EEC** 

**21 -**  **Day (μg**  **a.i./L) LC**  **50**

**(μg a.i./L)**  **NOAEC**

**(μg a.i./L)**  **Acute RQ**

**(Peak EEC/LC**  **50 )**  **Chronic**

**RQ (21**  **- day**  **EEC/NOAEC)** Al monds (CA Al mond) 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 Al mond) 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 0.0 4 < 0.30

Ground 27.6 26.6 0.0 4 < 0.27**64**



### 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 (μg**  **a.i./L) EEC** 

**21 -**  **Day (μg**  **a.i./L) LC**  **50**

**(μg a.i./L)**  **NOAEC**

**(μg a.i./L)**  **Acute RQ**

**(Peak EEC/LC**  **50 )**  **Chronic**

**RQ (21**  **- day**  **EEC/NOAEC)** 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 0.0 3 < 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 0.0 3 < 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 0.0 3 < 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 0.0 4 < 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 0.0 2 < 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 0.0 2 0.25

Ground 81.22 78.7 0.0 2 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 

### b. **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 b y assuming equilibrium partitioning fenpy razamine 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**65**



### (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 tox icity tests. As discussed in **Section 4.4.1**  of this assessment, there were three chronic sediment toxicity studies submitted in support of fenp yrazamine. 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 fenp yrazamine, 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

anal ys is shows the chronic LOC of 1 is exceeded with certainty with freshwater invertebrates f

or 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 fenp yr azamine but where exactl y the RQ falls is an uncertainty. The uncertainty

in these upper and lower bound RQs are discussed further in the **Risk Description**  **, S**  **ection 7.2.1** 
. **Table 23**  **. Chronic**  **RQs for risk of**  **f enpyrazamine exposure to freshwater benthic**  **invertebrates 1**  **,2** 

### . **Crop (Specific**  **scenario) Application** 

**Method Sediment** 

**EEC (μg a.i./**  **kg sedi**  **me nt** **) Pore** 

**Water EEC**  **(μg a.i./L pore**  **wa ter)**  **NOAEC**

**(μg a.i./kg**  **sedi me**  **nt) NOAEC (μg** 

**a.i./L pore wa** **ter) Sediment** 

**RQ Pore water** 

**RQ**
Al monds , 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**66**



### Table **23 .**  **Chronic RQs**  **for risk of f**  **enpyrazamine exposure to freshwater benthic invertebrates**  **1 ,2**  

### . **Crop (Specific**  **scenario) Application** 

**Method Sediment** 

**EEC (μg a.i./**  **kg sedi**  **me nt** **) Pore** 

**Water EEC**  **(μg a.i./L pore**  **wa ter)**  **NOAEC**

**(μg a.i./kg**  **sedi me**  **nt) NOAEC (μg** 

**a.i./L pore wa** **ter) Sediment** 

**RQ Pore water** 

**RQ**
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 μg a.i/kg sediment and 20 μg 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**  **f enpyrazamine exposure to estuarine/marine benthic**  **invertebrates 1,2**  **,3** 

### . **Crop (Specific**  **scenario) Application** 

**Method Sediment** 

**EEC (μg a.i./**  **kg sedi**  **me nt** **) Pore** 

**Water EEC**  **(μg a.i./L pore**  **wa ter)**  **NOAE C**  **,**

**(μg a.i./kg**  **sedi me**  **nt) NOAEC (μg** 

**a.i./L pore wa** **ter) Sediment** 

**RQ Pore water** 

**RQ**
Al monds , 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**67**



### Table **24 .**  **Chronic RQs**  **for risk of**  **f enpyrazamine exposure to estuarine/marine benthic**  **invertebrates 1,2**  **,3** 

### . **Crop (Specific**  **scenario) Application** 

**Method Sediment** 

**EEC (μg a.i./**  **kg sedi**  **me nt** **) Pore** 

**Water EEC**  **(μg a.i./L pore**  **wa ter)**  **NOAE C**  **,**

**(μg a.i./kg**  **sedi me**  **nt) NOAEC (μg** 

**a.i./L pore wa** **ter) Sediment** 

**RQ Pore water** 

**RQ**

1 Using 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
. 

### c. **Aquatic Plants**  RQs were estimated for listed and non
- listed vascular and non
- vascular (algae) plants. The most sensitive EC 50 

### values for vascular and non
- vascular plants were used with the peak EEC for all proposed uses of fenp yrazamine 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 EEC s for each use, as well as the most sensitive EC 50 

### and NOAEC values from available toxicity studies. For the proposed uses of fenpy razamine, 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 (μg**  **a.i./L) E**  **C 50** 

**(μg a.i./L)**  **NOAEC**

**(μg a.i./L)**  **Non -**  **listed**

**aquatic plants RQ**  **(Peak EEC/EC**  **50 )**  **Listed aquatic**

**plants RQ (Peak**  **EEC/NOAEC or EC**  **05 )**  Al monds (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**68**



### 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 (μg**  **a.i./L) E**  **C 50** 

**(μg a.i./L)**  **NOAEC**

**(μg a.i./L)**  **Non -**  **listed**

**aquatic plants RQ**  **(Peak EEC/EC**  **50 )**  **Listed aquatic**

**plants RQ (Peak**  **EEC/NOAEC or EC**  **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
.**69** 

### 7.1.2 **Non -** **target Terrest**  **r i** **al 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 fenp yrazamine
. **Table 26**  below summarizes the acute dose
-based RQs to birds for all proposed use s of fenp yrazamine. 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 u se . **Table 26**  **. Dose**  **- b**  **ased RQs for b**  **irds due to**  **exposure to proposed uses of f**  **enpyrazamine .**  **Use Size** 

**Class (gram**  **s) Adjusted** 

**LD 50**  **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 Straw berries 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 fenpy razamine. There were no acute LOC exceedances for any of the proposed uses on fenp yrazamine. 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).**70**



### 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. A cute 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 fenp yrazamine. 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 value s of these acute RQs are uncertain . T he 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
- def initive toxicity endpoints. **Table 27**  **. Dietary** **- based RQs for b**  **irds due to**  **exposure to proposed uses of f**  **enpyrazamine .**  **Use RQs**  **1**

**Exposure Short** 

**grass Tall** 

**grass Broadleaf** 

**plants Fruits/pods** **/seeds Arthropods**  Almonds , pistachios Ac ute < 0.05 < 0.02 < 0.03 < 0.003 < 0.02 Chronic 0.94 0.43 0.53 0.06 0.37 Lettuce Ac ute < 0.07 < 0.03 < 0.04 < 0.004 < 0.03

Chronic **1.25** 0.57 0.70 0.08 0.49 Grapes, bushberries, caneberries Ac ute < 0.07 < 0.03 < 0.04 < 0.004 < 0.03

Chronic **1.25** 0.57 0.70 0.08 0.49 Straw berries Ac ute < 0.09 < 0.04 < 0.05 < 0.01 < 0.03

Chronic **1.56** 0.71 0.88 0.10 0.61 Ginseng Ac ute < 0.09 < 0.04 < 0.05 < 0.01 < 0.03

Chronic **1.56** 0.71 0.88 0.10 0.61 Ornamentals Ac ute **< 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 

### b. **Acute and Chronic Risk to Mammals**  T
- REX pro vides 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 fenp yrazamine. **Table 28**  below summarizes the acute dose
-based RQs to mammals for all proposed use of fenp yrazamine . The acute endangered species LOC was exceeded for mammals eating short grass for only the proposed use on ornamentals
. There ar e 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 b y small and medium sized mammals eating tall grass, broadleaf plants, and arthropods was exceeded for al l 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 fenp yrazamine. There are no LOC exceedances for these RQs.**71**



### Acute dose
-based RQs for mammals ranged from 0.0004

– **0. 15**  thus indicating a potential for acute risks to endangered mammalian spe cies ingesting short grass for the ornamental use onl y. 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**  **d ose**  **- based RQs for ma**  **mmals due to**  **exposure to proposed uses of f**  **enpyrazamine .**  **Use Size** 

**Class (gram**  **s) Adjusted** 

**LD 50**  **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 Straw berries 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 (gram**  **s) Adjusted** 

**LD 50**  **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, 15 4395.66 **1.68** 0.77 0.94 0.10 0.66 0.02**72**



### Table **29 .**  **Chronic dose -**  **based RQs for mammals from exposure to proposed uses of fenpyrazamine**  **. Use**  **Size**

**Class (gram**  **s) Adjusted** 

**LD 50**  **RQs 1** 

**Short grass**  **Tall**

**grass Broadleaf** 

**plants Fruits/pods**  **Arthropods Seeds**  bushberries, caneberries 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 Straw berries 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 Straw berries 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 

### c. **Non -**  **target Beneficial Insects** The Agency

does not currently

conduct quantitative risk assessments for non
- target beneficial insects ( e.g. , honey

bee). Rather, the potential exposure of honey bees to pesticides is assessed qualitatively

based on laboratory

data and if available, field data. Furthermore, when used alone, fenp yrazamine , consistent with other carbox amide py razole fungicides , does not possess a mode of action consistent with systemic fungicide s 11



### . Therefore, potential exposure via transport within the plant to pollen and nectar is reduced
. Itis also noted that fenp yrazamine is classified as practically

non - toxic to honey

bee (acute contact LD 50 

### >100 ug a . i/bee) and was shown to be non - toxic at a dose of 100 μg a.i/bee in an acute oral exposure study
. Therefore, while the
11 Uptake of fenpyrazamine residues was observed in wheat, lettuce, and carrots in an accumulation in confined rotational crop study conducted under a greenhouse (MRID No. 48400043). However, under fi eld conditions, fenpyrazamine, S
- 2188
- DC, or S
- 2188
- OH residues were not detected in rotational field crops in Europe (Citation: Austria, 2011a. Draft assessment report on the active substance fenpyrazamine prepared by the rapporteur Member State Austria in the framework of Council Directive 91/414/EEC, January 2011 ).**73**



### potential exists via exposure pathways such as spray drift to impact insects like honey bees, the limited available data show that fenp yr azamine is not shown to be toxic. **d. Risks to Terrestrial Plants**  Seedling emergence and vegetative vigor studies are available for fenp yrazamine. The estimates of exposure g enerated b y TerrPlant and described in **Section 6.2.2**  were compare d to estimates of toxicity to estimate RQ for listed and non listed p l ants 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 ginsen g, 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 EC 25 

### 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 (<0.0 35 lbs a.i/A). Additionally , the EC 25 

### values for seedling emergence (monocot and dicot) were non definitive (>1.54 ad >0.53 for monocots and dicots, respectivel y). 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**  **, S**  **ection 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,

Straw berries , 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**74**



### 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**
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, straw berries, and ginseng, and 1.07 lbs a.i/A for ornamentals **Bolded** values represent LOC exceedanc es of the listed and non
- listed terrestrial plant LOC of 1 

### 7.2 **Risk Description** In risk description, the results from the risk estimation are interpreted and sy nthesized 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 fenp yrazamine , 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. 7.2.1**  **Risks to Aquatic**  **Animals a.**  **Potential for A**  **cutely Toxic Exposures**

 **Fish** The previous risk estimation indicate s a low potential for acutel y toxic exposures to freshwater and estuarine/marine fish animals from the proposed uses of fenpy razamine
. **The highest estimated acute RQs for freshwater fish are**  **3 times below the listed species LOC of 0.**  **0 5**  **and the lowest RQs a**  **re one order of magnitude lower .**  For acute risk to estuarine/marine fish, RQs were estimated from a non
- definitive endpoint (>3900 μg 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 LC 50 

### of >3900 μg a.i
. /Lwould 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.**  **0 5** 
.**75**



### Acute toxicity

data was available for two degradate s of fenp yrazamine 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 fenpy razamine 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 LC 50 

### values for freshwater and estuarine/marine fish (5.2 mg a.i/L and >3.9 mg a.i/L, respectivel y). 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 wh ere degradation of fenp yrazamine of S
- 2188
- OH and S
- 2188
- DC occurs of levels up to 22.9 percent and 22 percent applied, respectivel y. There were no other cases where degradate residues contributed to greater than 10 percent of the applied in soil. Once in the water column , f enpy razamine is moderatel y persistent to persistent in the water column, especiall y 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** Estua rine/marine invertebrates were shown to be more sensitive in ecotoxicological testing and as a result , the highest acute RQs for this **t axa marginally exceed the**  **acute restricted use LOC of 0.**  **1 with**  **aerial and ground application to ornamental (NJ nursery s**  **cenario) 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 fenpy razamine (MCNI, S
- 2188
- DC, and S
- 2188
- OH). The results of these studies were similar to tho se of the results of the freshwater fish degradate studies. In the case of MCNI (the most toxic of the degradates) the LC 50 

### was still approximately 10 times less toxic than parent fenp yrazamine. The degradates S
- 2188
- DC and S
- 2188
- OH were approximately

17 times less toxic than parent fenpy razamine. Although, there were no degradate studies conducted on estuarine/marine invertebrates , the degradation products are expected to be less toxic than parent fenpy razamine to this taxa as it was for freshwater inv ertebrates despite the fact that estuarine/marine invertebrates were shown to be more sensitive to parent chemical than freshwater invertebrates. Biodegradation and abiotic degradation of fenpy razamine 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. **b. Potential for**  **Chronically Toxic Exposures** 

 **Fis h**  Chronic toxicity

studies are available for freshwater and estuarine/marine fish as earl y life stage**76**



### studies. While the freshwater fish study (rainbow trout, MRID 48400003 ) reached a definitive NOAEC, the study

with an estuarine/marine species (sheepsh ead minnow, MRID 4840000 4 ) yi elded a non
- definitive endpoint, <39 μg a.i/L. While estimation of RQs with this endpoint will not be entirel y precise, it is still useful to quantify a lower bound estimate of risk since the RQs generated would be at least th at 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. **Fo r the proposed uses on fenpyrazamine**  **, estimated freshwater fish chronic RQs**  **ranged from 0.**  **0 2** 

**– 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 μg 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 μg a.i/L. Consequently , such unbounded RQs do not enable a conclusive determinati on of risk (or lack thereof) to be made. With the proposed uses of fenpy razamine, 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 μg a.i/L) resulted in a 4.3% reduction from the negative control. This response is considered relativel y 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 μg a.i/L) resulting in percent reductions from the contro l 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 fenp yrazamine.) When the chemical structure is input into ECOSAR, the results of 4 ECOSAR classes are returned that includes aliphatic amines, hydraz ines, amides, and thiocarbamates. For the aliphatic amines and hydrazine classes, onl y chronic results for fish are specified (as opposed to estuarine/marine fish) and for the amide and thiocarb amates classes there are specific chronic toxicity estimates for estuarine/marine fish estimated. The e stimates of a chronic NOAEC for fish range from 0.2 to 19.6 mg/L, depending on the chemical class. For fenpy razamine, the highest 1
- in
- 10 year 60 day average EEC was for the NJ ornamental use and was 80.35 μg/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 fenpy razamine in the water column
. The lower bound aspect of the risk quotient is mitigated due to the fact that**77**



### hydrol ys is is conservatively not included as a degradation pathway due to significant uncertainties in the hydro lysis study (MRID No. 48399923). The existing data on hydrol ys is indicates that fenp yrazamine 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 o f data available at environmentally relevant conditions. The exclusion of hydrol ys is from water column under neutral conditions contributes to the overall steady EEC values of fenp yr azamine 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 s ys tem was available. Therefore, the single anaerobic aquatic metabolism half life available for modeling wa s multiplied by

three. G iven the evidence for fenpy razamine degradation due to hydrolysis especiall y over alkaline environments and that fenpy razamine may

be less persistent than modeled over neutral environments , it is possible th at chronic EECs would be lower. Additionally , a new chronic EL S 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.

 **Aqua tic Invertebrates**  **( Water C**  **olumn)** 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 μg a.i/L for bounding purposes. The resultant RQs would therefore be preceded b y a “<” sign to distinguish these RQs because the actual NOAEC is known to be above 98 μg a.i/L . Consequentl y, 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
- ye ar 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 μg a.i/kg sediment and <20 μg a.i/L
. The resultant RQs would be preceded with a “>” sign to distinguish these RQs because the actual**78**



### NOAEC is known to be below 101 μg a.i/kg sediment and 20 μg a.i/L. Similarly , the most sensitive endpoints for the estuarine/marine benthic invertebrate were <3000 μg a.i/kg sediment and <250 μg 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 μg a.i/kg sediment and 250 μg a.i/L. Consequently , such unbounded RQs do not enable a conclusive determination of risk (or lack there of) to be made. Itis 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 poss ible 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 μg a.i/kg sediment ( **Table 16**  ), which is approximately 2.5 fold higher than the most sensitive freshwater benthic organism endpoint (<101 μg a.i/kg sediment) and almost 12 fold lower than the most sensitive estuarine/marine benthic invertebrate endpoint (<3000 μg a.i/kg sediment). Similarly, the highest pore water 1
- in
- 10 year 21
- d average EEC is 46.8 μg a. i/L( **Table 14**  **)** which is approximately 2 fold higher than the most sensitive freshwater benthic invertebrate endpoint (<20 μg a.i/L) and approximately 5 fold lower than the most sensitive estuarine/marine benthic invertebrate endpoint (<250 μg a.i/L). This illustrates the assumption that sediment and pore water EECs which are calculated incorporating a robust sampling of water
- sediment s ys tems 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 sufficientl y demonstrated that bound residues do not desorb into the water column based on aerobic aquatic and aerobic soil metabolism lab oratory studies , where exhaustive methods of extraction were used (MRID Nos. 48399920, 48399 927, 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.

 **Aq uatic Plants**  A quatic 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 b y a comparison of the peak EEC to the EC 50 

### of the toxicity study while the listed species RQ is derived b y a comparison of the peak EEC to the NOAEC of the study.**79**



### The LOC for both measures is 1. **Fo r**  **non -** **vascular aquatic plants, the non -**  **listed LOC was exceeded for all proposed use**  **s of fenpyrazamine except almonds and pistachios with the RQs ranging from**  **1. 3**  **0**

**– 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 rangi**  **ng from 1.51** 

**– 17.67**  **, indicating the potential for toxic**  **effects to this taxa.** V ascular aquatic plants were substantially less sensitive and there were no listed or non
- listed LOC exceedances for all proposed uses of fenpy razamine. Conservative EECs resulting from excluding hydrol ys is as a degradation pathway given fenpy

razamine’s uncertainties of hydrolysis under environmentall y relevant conditions are also applicable for aquatic plants in this case particularl y due to its impact between applications. As a result, peak EECs may

be substantially

lower when considering hydrol ys is as a viable degradation pathway
. . Additional non
- vascular aquatic plant toxicity studies were submitted for two degradation products of fenp yrazamine. Studies conducted on the freshwater green algae ( Pseudokirchneriella subcapita ) using the degradates S
- 2188
- DC and S
- 2188
- OH (MRIDs 48400019 and 48400020, respectivel y). Both studies determined that the degradate s that were tested were approximately 150 times less toxic to freshwater green algae than parent fenp yrazamine b y 3 orders of magnitude for
- 2188
- DC and S
- 2188
- OH (based on EC 50 

### values). As the NOAEC value was non
- definitive for parent fenpy razamine freshw ater green algae study , the EC 05 

### 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 fenpy razamine 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 fenp yrazamine. Biodegradation and abiotic degradation of fenp yrazamine in the w ater 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.

**7.2.2 Risks to Terrestrial**  **Animals a.**  **Potential for Acutely T oxic Exposures** 
 **Birds** The anal ys is 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 fenp yr azamine. **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 LD 50 

### 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 LD 50 

### value available, which is also a non
- definitive endpoint (LC 50 

### >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 LD 50

### /LC 50 

### 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**80**



### 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 <0.0 003**  **to <0.15**  **( Table**  **28 ).**  These RQ values are based the most sensitive acute toxicity endpoint available (>2000 mga . i/kg bw for the rat ( **Table 9**  ). Onl y 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 LD 50 

### 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. **b. Potential for Chronically Toxic Exposures** 

 **Birds Chronic diet**  **ary -**  **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 exceed s the LOC for birds ingesting short and tall grass as well as broadleaf plants exposed to fenpy razamine resulting from the ornamental use, and from ingesting only short grass for all other uses ( except almonds and pistachios). These chronic RQs are based o n 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. Itis 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.

 **Ma mmals**  **Chronic dose**  **- based**  **risks as sociate**  **d 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 al l 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
. Th ese 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 LOAE L 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).**81**



###  **Non -** **target beneficial insects and other non**  **- target terrestrial organisms**  The potential exposure of honey bees 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
. Itis noted that fenpy razamine is classified as practicall y non - toxic to honey bee (acute contact LD 50 

### >100 ug a
. i/ bee and an acute oral L C 50 

### of >100 a.i/bee )
. Clinical sings of toxicity

included bees showing lethargic sy mptoms at varying numbers that increased with concentration in the acute contact toxicity study
. While conceptually potential route s of exposure exist for fenpy

razamine to honey

bees and other insect pollinators, the very low toxicity of fenp yrazamine to honey bee s 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
. Sub lethal 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.

**7.2.3 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 list ed 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 EC 25 

### value, both the seedling emergence and vegetative vigor studies had a determined EC 25 

### 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 polic y is to use the EC 05 

### for that endpoint. In this case however, although the statistical regression model was able to converge , the model determined the EC 05 

### to be 0.0. As a result, the value of 0.035 was used to estimate RQs for listed dicot in the Ter rPlant model with the RQs being preceded b y a “>” sign to signify the RQs may

lie higher than this estimated value but to what extent is uncertain.

**7.2.4 Review of Incident Data**  As fenp yrazamine has not been previousl y approved for use in the United States, there are no incident reports for this chemical.

**7.2.5 Threatened and Endangered Species Concerns**  For listed species assessment purposes, the action area is considered to be the area affected**82**



### directly or indirectl y b y the Federal action and not merel y the immediate area involved in the action. At the initial screening
- level, the risk assessment considers broadl y described taxonomic groups and so conservatively assumes that list species within th ose 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 relativel y 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 actio n 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 properti es of the pesticide to determine the extent to which screening assumptions regarding an action area appl y 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 rel y 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 b y direct or indirect effects. For fenpy razamine , 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 fenp yrazamine contaminated food items
. Li sted species LOCs are exceeded for any other taxonomic group assessed (aquatic animals, aquatic plants, nontarget invertebrates). For the maximum proposed fenp yrazamine 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**83**



### A spatial co
- occurrence analysis would be necessary to delineate the action area. **7.2.6 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 toxici ty

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 fenp yrazamine application at the rates specified on the label. In reality , there is the potential for uneven application of fenpy razamine 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 fenpy razamine , maximum number of applications, and the shortest interval between applications. However, several model ing limitations are noted and should be considered in interpreting the results of this aquatic risk assessment.

• The frequency

at which actual fenp yrazamine uses approach the use estimates modeled is dependent on resistance to the fungicide , timing of applicati ons, 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 fenp yrazamine , 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 sp ecific 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**84**



### likely to be regionally

specific because of local hydroge ological 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 stratificatio n due to thermoclines ( e.g. , seasonal stratification in deep water bodies). Additionall y, 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 substantiall y 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. H owever, in reality , onl y 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 , ty pically 48 to 96 hours. In the absence of d ata 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 fenp yrazamine. 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 fenp yrazamine’s rate of hydrol ys is in the environment. The existing hydrol ys is study suggests th at fenpy razamine degrades over all environments, especiall y 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.**85**



### 48399929), which also sho ws a trend of decreased half
- lives at higher pHs. However, environmentally

relevant hydrol ys is data were not provided to the Agency for neutral environments (pH7). . In the absence of adequate data, EFED conservatively assumed that the chemical persist s to hydrolysis at pH 7
. This uncertainty could be addressed by

a guideline hydrol ys is study

conducted at environmentall y relevant temperatures. The study may be used to recalculate aquatic EECs more representative of fenpy razamine 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 s tudy (MRID Nos. 48399930). Only one system was evaluated in each study . Additional studies could provide a more robust representation for the degradation of fenpy razamine in suboxic environments. Therefore, more refined aquatic EECs , especiall y 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 resid ues 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 sufficientl y demonstrated that bound residues do not desorb into the water column based on aerobic aquatic and aerobic soil metabolism lab oratory studies , in which exhaustive methods of extraction were used (MRID Nos. 48399920, 48399927, and 48399929) . Second, unextracted residues comprised of a negligib le 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 unextrac ted residues was generall y 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 fenp yrazamine 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 fenp yrazamine. 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
.**86**



### The fifth uncertainty concerns the l acking 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 No s . 48399919 and 48399920, respectivel y) were considered since soils from the UK are traditionally similar in their physical chemical characteristics to soils that exist within the United States. **c. Exposure for Terrestrial Species**  This risk assessment relies on the best available estimates of environmental fate and physicochemical properties, maximum application rate of fenpy razamine , 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 fenpy razamine 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 fenp yrazamine dermal exposure to terrestrial o rganisms. The Agency

is actively

pursuing modeling techniques to account for dermal exposure via direct application of spray and b y 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 fenp yrazamine 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 fenp yrazamine to wildlife. The input and output file can be found in **Appendix C**
. **d. Effects Assessment** **87**



### As the data available to support the terrestrial and aquatic effects assessment for fenpy razamine is largely complete, the primary

uncertainty

with the available data is the presence of n on 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 fre shwater and estuarine/marine sediment toxicity studies, and terrestrial plant studies. However the non
- definitive endpoints were “<,” values (which would yi eld a “>” RQ) onl y for chronic estuarine/marine fish, freshwater and estuarine/marine sediment toxi city 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 generall y 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 provis ions for a generall y 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 fenpy

razamine than the surrogates, risks may be under
- or overestimated, respectivel y. 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 fenp yr azamine and fish are an appropriate surrogate for aquatic
-phase amphibians.**88**



###  **Use of the Most Sensitive Species Tested**  Although the screening risk ass essment 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 positi on 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. 

## 8. **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 7.2.6**  **b** 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 ripari us and Leptocheirus plumulosus yi elded 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 hydrol ys is and soil metabolism studies can be worked out a s lower estimates of aquatic exposure may result. However, the Agency

is not asking for any additional studies at this time.**89**



## 9. **REFERENCES**

 **Enviro nmental 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. **A erobic 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.**9 0** 

MRID Author(s) Year Title **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. 20 10 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. Unpublis hed 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.**91**



###  **Ecological Effects Studies**  MRID Author(s) Year Title 48399935 Hoberg, J.R. 2006 S
- 2188 Technical Grade
- Ac ute 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 Ac ute 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 Ac ute 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 Ac ute 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
- Ac ute 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 Oy ster ( Crassostrea virginica ) Under Flow
- Through Conditions. Smithers Viscient Laboratories 790 Main Street, Wareham, Massachusetts 02571
- 1037. Laboratory Report ID: 12709.6302. 81 p. 4839 9941 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: 1 2709.6303. 82 p. 48399942 Ashida, S. 2008 Ac ute 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.**92**

MRID Author(s) Year Title 48399943 Ashida, S. 2008 Ac ute 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
- Ac ute Toxicity to Bluegill Sunfish ( Lepomis macrochirus ) Under Flow
- Through Conditions. Unpublished study performed by Springborn Smithers Laboratories, 790 M ain Street, Wareham, Massachusetts 02571
- 1037. Laboratory report number 13048.6505. Study sponsored by Sumitomo Chemical Com pany and submitted by Valent U.S.A. Corporation. Study completed April 14, 2006. 89 p. 48399945 Cafarella, MA. 2006 S
- 2188 Technical Grade
- Ac ute 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 Com pany, 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 Chemic al Com pany, 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.**93**

MRID Author(s) Year Title 48400004 Lee, M.R 2010 V
- 10135 T.G. (S
- 2188 T.G.) Early Life
- Stage Toxicity Tes t 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. Sp ringborn 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
- Ac ute Oral Toxicity Test (LD50) with Northern Bobw

hite 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. L aboratory Project ID 13048.4105. S tudy sponsored by

S umitomo Chemical Com pany , Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation. S tudy initiation date April 1, 2006; completion date July 3, 2006. 102 p.**94**

MRID Author(s) Year Title 48400012 Stafford, J.M 2006 S
- 2188 Technical Grade
- Dietary Toxicity Test with the Mallard Duck (Anas platyrhynchos). Unpublished study performed by

S pringborn Smithers Laboratories, Snow Camp, North Carolina and Wareham, Massachusetts. Laboratory Project ID 13048.4106. S tudy sponsored by Sumitomo Chemical Com pany , Ltd., Tokyo, Japan and submitted by

V alent U.S.A. Corporation. S tudy initiation date June 12, 2006; completion date September 28, 2006. 99 p. 48400013 Staff

ord, 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 S tafford, J.M 2008 S
- 2188 Technical Grade
- Reproductive Toxicity Test with Northern Bobw

hite ( 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
- Ac ute 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 spons ored 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.**95**

MRID Author(s) Year Title 48400019 Matsuura, Y. 2008 Grow th 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 Grow th 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 comp leted March 19, 2008. 37 p. 48400021 Hoberg, J.R 2008 Grow th 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 , Follo wing 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, 20 10. 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, W areham, 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
- Ac ute 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.**96**



### Open Literature and **Government Reports** Burns, Lawrence, 1997. Exposure Analy sis 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/scipol y/ 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.**97**



## 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, bo th acute and chronic risk quotients (RQs) are calculated b y 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 correspo nding 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) **acu te 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) **c hronic 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) LC 50 

### (fish and birds), (2) LD 50 

### (birds and mammals), (3) EC 50 

### (aquatic plants and aquatic invertebrates, and (4) EC 25 

### (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**  Ac ute Risk EEC/LC 50 or LD 50/sqft or LD 50/day 0.5

Ac ute Restricted Use EEC/LC 50 or LD 50/sqft or LD 50/day (or LD 50 < 50 mg/kg) 0.2 Ac ute Endangered Species EEC/LC 50 or LD 50/sqft or LD 50/day 0.1 Chronic Risk EEC/NOAEC 1 **Mam mals**  Ac ute Risk EEC/LC 50 or LD 50/sqft or LD 50/day 0.5

Ac ute Restricted Use EEC/LC 50 or LD 50/sqft or LD 50/day (or LD 50 < 50 mg/kg) 0.2**98 Risk Presumption**  **RQ LOC**  Ac ute Endangered Species EEC/LC 50 or LD 50/sqft or LD 50/day 0.1 Chronic Risk EEC/NOAEC 1 **Aquatic Animals** Ac ute Risk EEC/LC 50 or EC 50 0.5

Ac ute Restricted Use EEC/LC 50 or EC 50 0.1 Ac ute Endangered Species EEC/LC 50 or EC 50 0.05 Chronic Risk EEC/NOAEC 1 **Terrestrial and Se mi** **- Aquatic Plants** 

Ac ute Risk EEC/EC 25 1 Ac ute Endangered Species EEC/EC 05 or NOAEC 1 **Aquatic Plants** Ac ute Risk EEC/EC 50 1

Ac ute Endangered Species EEC/EC 05 or NOAEC 1**99 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 **Ap plication and Chemical Information**  Enter Chemical Name Fenpy razam ine Enter Chemical Use Is the Application a Spray? (enter y or n) y If Spray W hat T yp e (enter ground or air) air Enter Chemical Molecular W eight (g/m ole) 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 LD 50 (m g/kg bw) 2000 Enter Mineau Scaling Factor 1.15 Enter Tested Bird We ight (kg) 0.178 **Mammal** Enter Lowest Rat Oral LD 50 (m g/kg bw) 2000 Enter Lowest Rat Inhalation LC 50 (mg/L) 0.61 Duration of Rat Inhalation Study (hrs) 4 Enter Rat W eight (kg) 0.35 

# Output **Results A**

**vian (0.020 kg )** Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 3.87E - 06 Maximum 1 - hour Vapor Inhalation Dose (m g/k g) 4.86E - 07 Adjusted Inhalation LD 50 3.40E+00 Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.43E - 07 **Exposure not Likely Significant** Maximum Post- treatment Spray Inhalation Dose (m g/k g) 1.03E - 01**100**

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 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 (m g/k g) 6.12E - 07 Adjusted Inhalation LD 50 3.63E+01 Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.68E - 08 **Exposure not Likely Significant** Maximum Post - treatment Spray Inhalation Dose (m g/k g) 1.29E - 01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 3.56E - 03 **Exposure not Likely Significant 101**  **Appendix** 

## Appendix C. Output of SIP Results **Table 1. Inputs Parameter**  **Value** Chemical name Fenpy razamine Solubility (in water at 25 o C; mg/L) 20.4 Mammalian LD 50 (mg/kg - bw) 2000 Mammalian test species laboratory rat Bod y weight (g) of "other" mammalian species Mammalian NOAEL (mg/kg - bw) 3000 Mammalian test species laboratory rat Bod y weight (g) of "other" mammalian species Avian LD 50 (mg/kg - bw) 2000 Avian test species northern bobwhite quail Bod y 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 Bod y weight (g) of other avian species NOAEC (mg/kg - diet) for 2nd other bird species Bod y 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. A** 

**vian 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**102**

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.**103 Appendix**  

## Appendix D. Output of TerrPlant Results
**TerrPlant v. 1.2.2 Table 1. Chemical Identity.**  **Chemical Name Fenpyrazamine**  **PC code 90109**  **Use Al**  **monds, pistachios Ap**  **plication Method Aerial**  **Ap plication 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 EC**  **25 NOA**  **EC EC**  **25 NOA**  **EC** 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**  **- Aq**  **uatic 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.**104**

**Table 1. Chemical Identity. Chemical Name**  **Fenpyrazamine PC code**  **90109 Use**  **Al monds, pistachios**  **Ap plication Method**  **Aerial Ap**  **plication 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 EC**  **25 NOA**  **EC EC**  **25 NOA**  **EC** 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**  **- Aq**  **uatic 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.**105**

**Table 1. Chemical Identity. Chemical Name**  **Fenpyrazamine PC code**  **90109 Use**  **Al monds, pistachios**  **Ap plication Method**  **Aerial Ap**  **plication 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 EC**  **25 NOA**  **EC EC**  **25 NOA**  **EC** 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**  **- Aq**  **uatic 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.**106 Appendix**  

## Appendix **E .**  **Sample PRZ** **M/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: pond 298.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**107**



### 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**108**



### 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**109**



### 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**110**



### 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 m g/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 applica tion 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. ap p. 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)**111**



### 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

---- ------ ------ ------ ------ ------ ------ ------ 1 961 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 19 85 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**112**



### 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**113**



## 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 NA Metabolite detected at pH4, pH 7, and pH 9.

S
- 2188
- DC 5
- Amino
- 2
- isopropyl
- 4
- (o
- tolyl)
- 1H
- pyrazol
- 3
- one 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 65.6 % at 7 days Study terminated

at 30 days.

MCNI 2
- Cyano
-N
- isopropyl
- 2
- (o
tolyl)acetamide 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 6.3% at 30 days Study terminated

at 30 days.**114** 

### Degradate **Identity Structure**  **Max% of Applied**  **and Days Post**  **Application Comments**  **Soil Photolysis (MRID No. 48399926 )**  S
- 2188
- OH 5
- Amino
- 4
- hydroxy
- 2
- isopropyl
4
- (o
- tolyl)pyrazol
- 3
- one 1.6 % at 30 days Study terminated

at 30 days.

S
- 2188
- DC 5
- Amino
- 2
- isopropyl
- 4
- (o
- tolyl)
- 1H
- pyrazol
- 3
- one 0.4 % at 21 days Study terminated

at 30 days.
**Aerobic Soil Metabolism** **(MRID No s**  **. 48399920 and 48399927**  **)** S
- 2188
- OH 5
- Amino
- 4
- hydroxy
- 2
- isopropyl
4
- (o
- tolyl)pyrazol
- 3
- one 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 2.8 % at 14 days Detected in UK

Silt Loam Soil (MRID No. 48399920). Study terminated at 120 days.**115** 

### Degradate **Identity Structure**  **Max% of Applied**  **and Days Post**  **Application Comments** 

MPPZ 5
- Amino
- 4
- (o
- tolyl)
- 1,2
- dihydropyrazol
- 3
- one 0.2 % at 120 days Detected in NJ

Silt Loam Soil (MRID No. 48399927). Study terminated at 370 days.

**A na**  **erobic Soil Metabolism (MRID No.**  **48399928 )**  S
- 2188
- OH 5
- Amino
- 4
- hydroxy
- 2
- isopropyl
4
- (o
- tolyl)pyrazol
- 3
- one 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 22 % at 364 days Detected in NJ

Silt Loam Soil (MRID No. 48399928). Study terminated at 364 days.**116** 

### Degradate **Identity Structure**  **Max% of Applied**  **and Days Post**  **Application Comments** 

MPPZ 5
- Amino
- 4
- (o
- tolyl)
- 1,2
- dihydropyrazol
- 3
- one 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 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 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 0.8% at 61 days Detected in

Calwich Lake Water

– Silty Clay Loam Seiment (MRID No. 48399929). Study terminated at 100 days.**117** 

### Degradate **Identity Structure**  **Max% of Applied**  **and Days Post**  **Application Comments** 
**A naerobic Aquatic**  **Metabolism (MRID No. 48399930)**  S
- 2188
- OH 5
- Amino
- 4
- hydroxy
- 2
- isopropyl
4
- (o
- tolyl)pyrazol
- 3
- one 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 90.3 % at 63 and 120 days Detected in MS

Creek Water

– Clay Sediment (MRID No. 48399930). Study terminated at 364 days. **Terrestrial Fiel d Dissipation (MRID Nos. 48399931, 48399932, 48399933, and 48399934)**  S
- 2188
- DC 5
- Amino
- 2
- isopropyl
- 4
- (o
- tolyl)
- 1H
- pyrazol
- 3
- one 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 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.**118** 

### Degradate **Identity Structure**  **Max% of Applied**  **and Days Post**  **Application Comments** 

S
- 2188
- DC 5
- Amino
- 2
- isopropyl
- 4
- (o
- tolyl)
- 1H
- pyrazol
- 3
- one 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 42.0 % at 3 Days Detected during

depuration phase at low dose concentration in edible fish tissue. Percentage represents porti on of total radioactive residue recovered. Study terminated at 14 days of depuration.**119**



## 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 fenp yrazamine, 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 exp osure 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 fenp yrazamine 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 fenp yrazamine. Although definitive EC 50 

### values were achieved for the transformation products exposed to freshwater green algae, the data show that parent fenp yrazamine is more toxic to freshwater green algae b y at least one order of magnitude. Therefore, available data on three transformation products to fenpy razamine exposed to three aquatic taxa show that parent fenp yrazamine 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 fenp yrazamine. **T able**  **G -**  **1 . Toxicity Comparison of Parent Compound and Transformation Products.**  **A**

**Test Material M**  **W**

**(g/m ol)**  **Test Species Endpoint**  **Toxicity Value in m**  **g/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 LC 50 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 EC 50 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**120**

**Test Material M**  **W**

**(g/m ol)**  **Test Species Endpoint**  **Toxicity Value in m**  **g/L (95% Confidence**  **Interval) Degradate Toxicity** 

**Expressed in Parent Compound**  **Equivalents in mg/L (95% Confidence**  **Interval) B**  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 EC 50 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 us ed 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 fenpy razamine and its major degradates alongside of those endpoints predicted b y ECOSAR. For acute exposure, parent fenp yrazamine 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 yi elded, it is noted that the uncertainties and limitations associated with structure activity relationship anal ys es 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 onl y one cas e where ECOSAR predicted an endpoint where the degradate toxicity was more sensitive than parent fenpy razamine. 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 fenp yrazamine, 0.37 mg/L. The other chronic NOAEC value available for fenp yrazamine was determined to be lower than the lowest concentration tested (<0.039 mg/L).**121**



### Tabl **e G** **- 2**  **. ECOSAR Est imates of Transformation Product Toxicity.**  **A Compound (Che**  **mical Class)**  **C Estimated Toxicity Value (mg/L)** 

**96 -**  **hr FW fish EC 50**  **48 -**  **hr FW**

**Daphnid LC 50**  **Fish NOAEC Daphnid**  **NOAEC 96**  **- hr EC**  **50**

**Green Algae** Fenpyrazamine B (Py razole ) (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) (>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
- CH 2 OH
- DC (Aliphatic amines) 5773.72 520.75 1167.33 29.67 904.74 S
- 2188
- DC conjugate S
- 2188
- CH 2 OH
- DC (Hydrazines) 30.15 25.41 4.21 D 4.32 D 0.15 S
- 2188
- DC conjugate S
- 2188
- CH 2 OH
- DC (Benzyl alcohols) 53419 E 32828 E 2361.2 D 2411.9 D 4130.2 S
- 2188
- DC conjugate S
- 2188
- CH 2 OH
- 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 thi s 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.