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# Revised Problem Formulation for the Environmental Fate, Ecological Risk, and Endangered Species Assessments in Support of the Registration Review of Fluridone

Fluridone

CAS Number 59756-60-4

PC Code 112900

Prepared by: Katrina White, Ph.D., Biologist (Effects Scientist) Ibrahim Abdel-Saheb, Ph.D, Environmental Scientist Tiffany Mason, Environmental Engineer

Reviewed by: Jean Holmes, Senior Biologist William Eckel, Senior Fate Scientist Tom Bailey, Branch Chief U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division

Environmental Risk Branch II 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460

February 24, 20102 of 80 Table of Contents

1. Purpose..................................................................................................................... ............... 4

2. Problem Formulation ......................................................................................................... ..... 4 2.1. Nature of Regulatory Action........................................................................................... 4

2.2. Previous Risk Assessments............................................................................................. 4

3. Stressor Source and Distribution ............................................................................................ 5

3.1. Mechanism of Action in Plants....................................................................................... 5 3.2. Overview of Pesticide Usage.......................................................................................... 5 3.3. Environmental Fate and Transport.................................................................................. 7 4. Receptors................................................................................................................... ............ 13 4.1. Effects to Aquatic Organisms ....................................................................................... 14 4.2. Effects to Terrestrial Organisms ................................................................................... 16

4.3. Incident Database Review............................................................................................. 18 4.4. Ecosystems Potentially at Risk ..................................................................................... 20 5. Assessment Endpoints ........................................................................................................ .. 20 6. Conceptual Model............................................................................................................ ..... 21 6.1. Risk Hypothesis ........................................................................................................... . 21 6.2. Conceptual Diagram ..................................................................................................... 22 7. Analysis Plan ............................................................................................................... ......... 24

7.1. Stressors of Concern ..................................................................................................... 2 5 7.2. Measures of Exposure................................................................................................... 25 7.2.1 Aquatic Organisms................................................................................................ 26 7.2.2 Terrestrial Organisms............................................................................................ 26

7.3. Measures of Effect ........................................................................................................ 27 7.4. Integration of Exposure and Effects ............................................................................. 28

7.5. Deterministic and Probabilistic Assessment Methods.................................................. 29 7.6. Endangered Species Assessments................................................................................. 29 7.7. Drinking Water Assessment ......................................................................................... 29 7.8. Preliminary Identification of Data Gaps....................................................................... 30

7.8.1 Fate..................................................................................................................... ... 30

7.8.2 Effects .................................................................................................................. . 31

7.9. Other Information Needed for the Risk Assessment .................................................... 40

8. References.................................................................................................................. ........... 40 8.1. Open Literature ........................................................................................................... .. 40

8.2. Submitted Fate Studies ................................................................................................. 43

8.3. Submitted Effects Studies............................................................................................. 473 of 80 List of Tables

Table 3-1. Summary of Secti on 3 Products, Formulations, and Maximum Application Rates for Products Containing Fluridone* ................................................................................................. .... 7

Table 3-2. General chemical and envir onmental fate properties of fluridone ............................... 8

Table 3-3. Maximum Reported Amounts of Fluridone Degradation Products 1 .......................... 10

Table 4-1. Summary of Sensitive Endpoints for Aquatic Organisms Under Consideration for

Use in the Risk Assessment for Fluridone a ................................................................................... 15

Table 4-2. Summary of Sensitive Toxicity Endpoints for Terrestrial Organisms Under

Consideration for Use in Risk Assessment*................................................................................. 17

Table 4-3. Summary of Incidents Reported in the Ecological Incident Information System (EIIS)

for Fluridone .................................................................................................................. ............... 19

Table 7-1. Summary of Envi ronmental Fate Studies................................................................... 30

Table 7-2. Available Ecological Effects Data for Terrestrial Animals Exposed to Fluridone .... 32

Table 7-3. Available Ecological Effects Data for Aquatic Animals Exposed to Fluridone ....... 33

List of Figures

Figure 3-1. Structure of fluridone and its degradation products.................................................. 11

Figure 3-2. Other degradates is olated during fluridone lab phot olysis study in amounts up to 6.8% of the applied radioactivity.............................................................................................. .... 12

Figure 6-1. Conceptual Model Depicting Exposure Pathways a nd Potential Risks to Aquatic Organisms from the Use of Fluridone to Contro l Aquatic Vegetation. Dashed lines indicate routes of exposure considered of lower importance for fluridone................................................ 23

Figure 6-2. Conceptual Model De picting Exposure Pathways and Po tential Risks to Terrestrial Organisms from the Use of Fluridone to Contro l Aquatic Vegetation. Dashed lines indicate routes of exposure considered of lower importance for fluridone................................................ 24

Appendices

Appendix A: Data Call In Tables............................................................................................... .. 53

Appendix B: Summary of Toxicity Data..................................................................................... 64

Appendix C: Preliminary TREX Output for NMF ...................................................................... 77

Appendix D: ECOSAR (version 1.0) Results for 3-trifluoromethyl benzoic acid ...................... 794 of 80 1. Purpose

The purpose of this problem formulation is to pr ovide an understanding of what is known about the environmental fate and ecological effects of th e registered uses of fl uridone. Fluridone is a systemic aquatic herbicide. This document will provide a plan for analyzing data relevant to fluridone and for conducting environmental fa te, ecological risk, and endangered species assessments for its registered uses. Additionally, this problem formulation is intended to identify data gaps, uncertainties, and poten tial assumptions used to address those uncertainties relative to characterizing the ecological risk associated with the registered uses of fluridone.

2. Problem Formulation

2.1. Nature of Regulatory Action

Under the Federal Insecticide, F ungicide, and Rodenticide Act (FIF RA), all pesticid es distributed or sold in the United States ge nerally must be registered by the United States Environmental Protection Agency (USEPA). To determine whet her a pesticide can be registered, the USEPA evaluates its safety to non-target species base d on a wide range of environmental and health effects studies. In 1996, FIFRA was amended by the Food Quality Protection Act, and EPA was mandated to implement a new program for the periodic review of pesticides, i.e ., registration review ( http://www.epa.gov/oppsrrd1/ registration_review/ ). The registration review program is intended to ensure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse

effects to human health and the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the new registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely.

As part of the implementation of the new Regist ration Review program purs uant to Section 3(g) of FIFRA, the Agency is beginni ng its evaluation of fl uridone to determine whether it continues to meet the FIFRA standard for registration. This problem formulation for the environmental fate and ecological risk assessment chapter in support of the registration review will be posted in the initial docket opening the public phase of the review process.

2.2. Previous Risk Assessments

In 2004, a human health risk assessment for fl uridone and a drinking water assessment were completed to support the tolerance decision in th e Tolerance Reregistrati on Eligibility Decision document (USEPA 2004a; USEPA 2004b). A corres ponding ecological risk assessment was not completed. The most recent ecological risk assessment was completed in 1991 (USEPA 1991). The review included reference to a biological opinion written by the U.S. Fish and Wildlife Service which found, "the registration of this pr oduct as proposed is li kely to jeopardize the

continued existence of all listed U.S. freshwater aquatic species including plants, fishes, reptile, amphibians, and invertebrates (principally mussels ) and is likely to destro y or adversely modify all aquatic designated critical habitat" (USEPA 19 91). The review predicted direct and indirect risk to reproduction of aquatic organisms and ri sk to aquatic vegetation. The review requested the following studies:5 of 80 • 123-2 Tier II Aquatic Plant Growth,

• 72-1 Acute Toxicity Test for Freshwater Fish,

• 72-4 Freshwater Invertebrate Lifecycle, and

• 72-3 Testing for Estuarine and Marine Organisms.

The review concluded that a risk assessment on revisions for increased application rates could not be completed until data were submitted. The re view stated that the la bel requires that the State Fish and Game Agency of the U.S. Fish and Wildlife Service should be contacted prior to making applications to avoid impact on threatened or endangered species. Current labels have a

statement that state and local wa ter authorities should be consulted prior to use of the product; however, it is not a restricted use pesticide. Additionally, the label does not mention the protection of threatened or e ndangered species. The models, pr ocedures, and data requirements for the ecological risk assessment process have a ll been modified since the previous ecological risk assessment was completed.

3. Stressor Source and Distribution

3.1. Mechanism of Action in Plants

Fluridone is a systemic aquatic herbicide that is used to manage aquatic weeds in ponds and lakes. It does not belong to a specific chemical class of pe sticides (Wood 2009). The mode of

action is inhibition of carotenoid biosynthesis at the phytoene desatu rase step of the isoterpenoid pathway (Popova 1996; Schmitz 1986) . The lack of carotenoid pigments in leaves results in chlorophyll bleaching by sunlight and preven ts plants from synthesizing food (Doong et al. 1993). This mode of action is also seen with pyridazinones and pyr idinecarboxamides (HRAC 2005). Fluridone has also been shown to inhi bit the production of abscisic acid (MacDonald et
al. 2008).

3.2. Overview of Pesticide Usage

Fluridone was originally registered for use in the United States in 1960. There are currently 18 registered products, with 12 nati onal labels (Section 3) , ten special local need labels (Section 24c), and three experimental use permits. Ta ble 3-1 lists the Secti on 3 labels currently registered. Formulations of fl uridone include emulsifiable con centrate, liquid, pelleted/tablet,

and soluble concentrate/solid. It may be applied directly to wa ter as a broadcast spray through both aerial and ground di spersal methods (Fox et al. 1996; BLM 2005) or to the subsurface of

water. 1 The water bodies where it may be applied in clude ponds, lakes, rese rvoirs, potable water sources, drainage canals, and irrigation canals. Application equipment includes a metering pump, sprayers, trailing hose, and we ighted trailing hose. It is part icularly useful for the control of hydrilla in the southern states and Eurasian milfoil in the northern states (USEPA 2004b). The labels permit treatments of up to 90 part s per billion (ppb) for ponds and up to 150 ppb for lakes and reservoirs, with a maximum cumulative application of 150 ppb pe r growth cycle. The reported maximum application rate in lbs active ingredient per acre (lbs ai/acre) is 4.9 pounds

1 Labels do not have specific instructions for application of fluridone by air; however, the labels do not prohibit application by air. Therefore, it is assumed that aeria l application of fluridone is approved on the label.6 of 80 active ingredient per acre (lbs a i/A) for aquatic areas, lakes, ponds , and reservoirs, 2 lbs ai/A for drainage systems and streams, rivers, or cha nneled water, and 0.865 lbs ai/A in human drinking water systems (USEPA 2009a). The maximum app lication rate in human drinking water systems is 20 ppb (USEPA 2009a). It is prohibited from application in tidewat er or brackish water; however, as it may be applied in freshwater streams and rivers it could easily enter the

estuarine/marine environment. Concentrations must be maintained over a long period of time (30-90 days) in order for fluridone to be effective. Repeated app lications may be needed to keep the concentration high enough for weed control. Some labels instru ct the user to use an enzymelinked immunoassay (ELISA) test to monitor the concentration of fluridone in water and repeat applications as needed. Due to the mode of action of fluridone, it is important that it be applied to plants that are actively growing. For this reason, many applications are made in the spring (MacDonald et al. 2008). Typically, the number of appli cations is 1-3 with a minimum of 2-3 weeks between treatments (USEPA 2003). Some precautionary statements are summarized

below.

Example Precautionary Statements on Labels

• Permits: Consult with appropriate state or lo cal water authorities before applying since state or local agencies may require permits to use product.

• Chemigation: Do not apply through any type of irrigation system.

• Hydroponic Farming: Do not use tr eated water for hydroponic farming.

• Greenhouse and Nursery Plants: Do not use wa ter which has been tr eated to irrigate greenhouse or nursery plants unless chemical assays of the water indicate fluridone

residues are less than one parts per billion (ppb).

• Maximum Use Rates: Do not apply more th an a total of 90 ppb in ponds and 150 ppb in lakes and reservoirs per annual growth cycl e. These maximum concentrations are the

amounts of fluridone calculated as the target application rate, NOT the concentration determined by analysis of flur idone in the treated water.

• Waiting Periods: If application rates are 150 ppb or less, treated water may be used immediately with no waiting period for drin king (potable) water (including watering livestock and pets), fishing or swimming. See specific restrictions below for Potable Water Intakes and Irrigation.

• Potable Water Intakes: In lakes and reservoi rs or other sources of potable water, DO NOT APPLY at application rate s greater than 20 ppb within 1/4 mile (1320 feet) of any functioning potable water intake. If rates are between 6 and 20 ppb, the product MAY BE APPLIED where functioning potable water intakes are present.

• Note: Existing potable water in takes which are no longer in us e, such as those replaced by potable water wells or connections to a m unicipal water system, are not considered to be functioning potable water.

• Irrigation: Irrigation us ing water treated may injure the irrigated vegetation. Instruct those who use product-treated water to follow the recommended waiting pe riods listed in the table below and to assay the water for fluri done residues. For crops grown on low organic and sandy soils and irrigated w ith product-treated water, the potential for crop injury is greater than for crops gr own on heavier soils.7 of 80 Table 3-1. Summary of Section 3 Products , Formulations, and Maximum Application Rates for Products Containing Fluridone*

Product Name EPA Reg. Num.

Percent ai Formulation

Pounds ai/amount product Maximum Application Rate

WhiteCap SC

61842-11

41.7% ai Liquid 4 lbs ai/ gallon product 90 ppb in ponds and 150 ppb in lakes, reservoirs, and static canals per annual growth cycle

4.88 lbs ai/A 1

Sonar*SRP

67690-3

5.0% ai Pellet/tablet 0.05 lbs ai / pound product 90 ppb in ponds and 150 ppb in lakes, reservoirs, and static canals per annual growth cycle

2.0 lbs ai/A 2

Sonar*A.S.

67690-4

41.7% Emulsifiable Conc. 4 lbs ai/gallon product 90 ppb in ponds and 150 ppb in lakes, reservoirs, and static canals per annual growth cycle

4.88 lbs ai/A 1

Sonar*X

67690-12

5.0% ai Pellet/tablet 0.05 lbs ai / pound product 90 ppb in ponds and 150 ppb in lakes and reservoirs per annual growth cycle

4.9 lbs ai/A 3

Sonar Q Quick

Release

676901-21

5.0% ai Pellet/tablet 2 lbs ai/40-pounds product 90 ppb in ponds and 150 ppb in lakes and reservoirs per annual growth cycle

4.9 lbs ai/A 3

Fluridone SC

67690-30

41.7% ai Liquid 4lbs ai/gallon product 90 ppb in ponds and 150 ppb in lakes, reservoirs, and static canals per annual growth cycle

4.88 lbs ai/A 1

Fluridone SRP

67690-32

5.0% ai Pellet/tablet 2 lbs ai/40-pounds product 90 ppb in ponds and 150 ppb in lakes and reservoirs per annual growth cycle

4.9 lbs ai/A 3

SonarOne*

67690-45

5.0 % ai Pellet/tablet 0.05 pound ai/pound product 90 ppb in ponds and 150 ppb in lakes and reservoirs per annual growth cycle

4.9 lbs ai/A 3

Sonar*Extra

67690-48

3.79% ai Liquid 0.08 lbs ai/quart product 0.48 lbs ai/A followed by 2 applications at 0.24 lbs ai/A with a 20 day interval

Fluridone Technical

83504-2

99.3% ai Not applicable

Fluridone Technical

67690-31

99.2% ai Not applicable

ai = active ingredient *The list of currently registered products was obtained from OPPIN in April 2009. The maximum application rates

were obtained from USEPA 2009a. 1 Calculated from 156.2 oz product/acre x 1gallon/128 oz conversion factor x 4 lbs ai/gallon = 4.88 lbs ai./Acre. 2 Calculated from 40 pounds/acre x 0.05 lbs ai/pound = 2 lbs ai/Acre 3 Calculated from 98 pounds Sonar X per treated surface Acre x 0.05 lbs ai/pound Sonar X = 4.9 lbs ai/A 4 Calculated from 6 quarts/acre x 0.08 lbs ai/quart = 0.48 lbs ai/A. and 3 quarts /acre x 0.05 lbs ai/quart = 0.24 lbs

ai/A.

3.3. Environmental Fate and Transport

Registrant-submitted data defini ng the physical, chemical, fate, and transport characteristics associated with fluridone (1-methyl-3-phenyl-5-( α , α , α -trifluoro- m -tolyl)-4-pyridone) are summarized in Table 3-2. As part of registration review, available fate studies for fluridone have8 of 80 been reevaluated. The fate and transport of flur idone in the environment is briefly discussed

below.

Under field conditions, photolysis and soil adso rption are the major routes for fluridone dissipation.

The results of two fish bioaccumulation studi es along with low n-octanol/water partition coefficient (1.87) tend to indicate that fluridone has a low potential to bioaccumulate in fish.

Table 3-2. General chemical and environmental fate properties of fluridone

Chemical/Fate
parameter Value Source (MRID)

Molecular Weight (g/mol) 329.3 Footprint @ http://sitem.herts.ac.uk/aeru/footprint/en/, accessed on April 28, 2009

Vapor Pressure (mm Hg at

25 o C) 9.77 x 10 -8

<1 x 10 -7 USEPA 2007c Weed Science, 4 th Ed. 2002

Henry's law constant at 25 o C (Pa m 3 mol -1 ) 3.57 x 10 -04 Footprint @ http://sitem.herts.ac.uk/aeru/footprint/en/, accessed on April 28, 2009

Octanol-water Partition Coefficient (Log K OW ) 1.87 Footprint @ http://sitem.herts.ac.uk/aeru/footprint/en/, accessed on April 28, 2009

Water Solubility (mg/L; at 25 °C) 12.3 Footprint @ http://sitem.herts.ac.uk/aeru/footprint/en/, accessed on April 28, 2009

Hydrolysis half lives (days) Stable MRID# 30257

Aqueous photolysis half-life (d) 0.9 – 2.3 MRID# 103326

Aerobic Soil Metabolism half-life (y) Stable MRID# 135217

Anaerobic Soil Metabolism half-life (days) Stable Acc. No. 070937

Anaerobic Aquatic Metabolism half-life (days) Stable MRID# 103327

Aerobic Aquatic Metabolism half-life (days) 117 MRID# 44154801

Organic carbon normalized partition coefficients (K OC ) 260 – 740 L/kg MRID# 44138501

Fish Bioconcentration Factor (BCF) 3.97x (whole fish) 4.32x (non-edible tissues) 1.46x (edible tissues) MRID# 1627759 of 80 3.3.1.a Degradation
Fluridone is stable to hydrolysis (MRID 0030257) . Fluridone photodegrades in distilled water rapidly with a half - lives of 55 hours (pH 6), and 34 hours in natural pond water. Photoproducts include volatile and non-volatile compounds (MRID 00103326). Volatile photoproducts were formed through destruction of the pyridinone rin g. Degradation in wate r is attributed to photolysis and adsorption by aquatic plants a nd hydrosoil (October 1978 Trip Report Document, Sonar Aquatic Tour P000071).

Fluridone in water/methanol solution and expos ed to sunlight for 53 days produced volatile photoproducts: 3-trifluoromet hyl-benzoic acid (the chemical identity information and structures for these compounds are shown in below), benzoic acid (IV, CA S Number 65-85-0), 3- trifluoromethyl-benzaldehyde (V, CAS Number 454-89-7), benzaldehyde (VI, CAS Number 100-52-7), and N-methyl formamide (NMF, VII). These products suggest that fluridone photolysis occurs through degrad ation of the pyridinone ring. Ben zaldehydes rapidly degraded to benzoic acid. Both benzoic acids slowly degrad ed in distilled water but 3-trifluoromethyl

benzoic acid was stable in lake water. NMF did not degrade in lake or distilled water exposed to sunlight. NMF did completely degrade in lake wa ter held as dark control (suggesting microbial activity involved).

In distilled water, N-methyl Formamide (NMF ) and 3-trifluoromethyl benzoic acid (CAS Number 454-92-2) were the major photoproducts that were observed after 27 days exposure (3:1 ratio) (Acc. No. 070937). In lake water, NMF, 3-trifluoromethyl-benzoic acid, and benzoic acid (1:1:1 ratio) were the ma jor photoproducts present.

Under aerobic aquatic and anaerobic aquatic conditions, fluridone will decline at a very slow rate with half- lives of 117 days (MRID 44154801) , and >365 (MRID 103327), respectively. The degradation of fluridone in soil (under aerobic an d anaerobic soil cond itions) was highly variable. Fluridone is very pers istent in soils with an appare nt half-life of approximately 6 months although some studies indi cate that its half life may be as long as 2 to 5 years. Degradation products also persist in th e soil but are as ye t uncharacterized.

Figure 3-1 and Figure 3-2 list all de gradates identified in labora tory studies and their amounts, followed by chemical structures for each degradate.10 of 80Table 3-3. Maximum Reported Amountsof Fluridone Degradation Products1Degradate Maximum % ofApplied (time ofmaximum)StudyDuration(day)% of Applied at StudyTerminationStudy Type MRID Monitoring Data?[Parentcompound]Not applicable 27365302365N/A (stable)36-65N/A (stable)46 (water), 38.6(sediment)27.6 – 75.9 (in solution)HydrolysisAqueous photolysisAnaerobic aquatic metabolismAerobic aquatic metabolismAdsorption/Desorption/LeachingAquatic field dissipationMRID# 30257MRID# 103326MRID# 103327MRID# 44154801MRID# 44138501MRID# 162339NoNMF74 (day 27)27 74 Aqueous photolysis MRID# 103326 NoFluridone acid 2.6 30 0.6 Aerobic aquatic metabolismMRID# 44154801No1,4-dihydro-1-methyl-4-oxo-5-(3-triflouromethyl)-phenyl ) - 3 - pyridinecarboxylicacidNot measured 365 N/AAnaerobic aquatic metabolismMRID# 103327NoBenzaldehyde 2 (day 7) 27 0.5 Aqueous photolysis MRID# 103326 No3CF3-benzaldehyde0.6 (day 7) 27 0.3 Aqueous photolysis MRID# 103326 NoBenzoic acid40 (day 21)27 0.7 Aqueous photolysis MRID# 103326 No3CF3- Benzoicacid33 (day 21)27 24 Aqueous photolysis MRID# 103326 No1Degradates with >10% of applied parent equivalents are in bold. Refer to chemical names and structures in Figure 3-1.11 of 80 Fluridone (Parent Compound)

3-trifluoromethyl benzoic acid 3-trifluoromethyl benzaldahyde (V)

Benzoic Acid (IV) Benzaldehyde (VI)

N-methyl Formamide (VII) 1,4-dihydro-1-methyl-4-oxo-5-(3- triflouromethyl)- phenyl ) - 3 - pyridinecarboxylic

acid

Figure 3-1. Structure of fluridon e and its degradation products12 of 80 Figure 3-2. Other degradates isolated during fluridone lab photolysis study in amounts up to 6.8% of the applied radioactivity

3.3.1.b Transport

Fluridone has relatively high potential for sorption to hydrosoil or sediment. Laboratory studies

show that fluridone residues are ad sorbed strongly to soils. Flur idone was sorbed to soils with

Freundlich K ads values ranging from 2.16 to 28.0 L/kg; and K

oc values range from 260 to 740 L/kg (MRID 44138501). Based on its K

oc values and according to the mobility classification presented by the Food and Agricultural Organizat ion of the United Nations (FAO); fluridone is considered as moderately mobile. Open literature studies reported K OC values ranging from 270 to 6400 L/kg (BLM 2005). These studies will be evaluated to determin e whether the reported

values are reliable for use in the environmental fate characterization.

3.3.1.c Aquatic Field Dissipation
Under field conditions, fluridone ap parently dissipates from hydr osoil by gradual desorption into the water where it photodegrades. However, the degree of photodegradati on in the aquatic field environment will be influenced by several vari ables, namely, degree of weed infestation, depth of

water, cloud cover, etc.

Liquid fluridone decreased in concentration logar ithmically with time when applied in two North Carolina ponds at 1.0 lb ai/A and 2.0 lb ai/A. Estimated time to reach a concentration of zero was 64 and 69 days respectively. No observed decr ease in a treated Virginia pond was seen over a 53 day period when a pellet formulation at 1.0 ai/A was used. It is specul ated that the reduced loss due to photolysis was because of shadi ng in the Virginia pond (Langeland and Warner 1986). Half-lives ranging from 4-7 days were reported for fluridone in Canadian fish ponds applied at 70, 700, and 5000 μg ai/L (Muir et al . 1980). In 12 ponds located across the United

States and one in Canada treate d with liquid fluridone, the half-lives ranged from 5-60 days (average 20 days). Lake half-lives less than 1 week have been attributed to dispersion, dilution, and degradation and/or adsorption (West et al . 1983). Ponds treated w ith pelleted fluridone had reached the maximum concentration approximately 14 days following treatment. Then fluridone levels began to decline at a similar rate as seen with the liquid fluridone.

Hydrosoil degradation has only been observed in laboratory experiments. Degradation has not been observed in aquatic systems. It is be lieved that desorption followed by photolysis is13 of 80 responsible for the loss from sediments. In ponds treated with liquid fluridone, hydrosoil concentrations reached maximum within approxim ately 14 days after treatment. The average

half-life was found to be 3 months. No fluri done was found in treated lake sediments (West et
al . 1983).

Fluridone was found to have a half-life in surface water of 21 days (Mackay et al. 1997), an anaerobic aquatic half-l ife of 9 months and an aerobic ha lf-life of 20 days (Tomlin 1994, USEPA 1982). When basing the fluridone ha lf-life on its estimated photolysis in water, the surface water half-life was 12-36 days, and the ground wate r half-life based on estimated unacclimated aqueous aerobic biodegradation wa s found to be 88-383 days (Howard et al. 1991).

3.3.1.d Bioaccumulation
In a bioconcentration study with crayfish, fluridone residues concentrated in fish tissues at a factor of 3.97X for whole fish, 4.32 for non edible tissues, and 1.46X for ed ible tissues (MRID # 162775).

Fluridone has a relatively low octanol/water partition coefficient. Based on the K

ow of 1.87,

fluridone would have a low potential for bioaccumulation in fish (Acc. No. 070937).

3.3.1.e Impaired Water Bodies

Fluridone is not identified as a cau se of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Ac t, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=88

5 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for fluridone, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and

TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the exte nt possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppfead1/cb/ ppdc/2006/november06/session1- sop.pdf ), in order to ensure they can be used qua ntitatively or qualitatively in pesticide risk

assessments.

4. Receptors

The receptor is the biological entity that is exposed to the stressor (USEPA 1998). Consistent with the process described in the Overview Document (USEPA 2004d), the risk assessment for fluridone relies on a surrogate species approach. Toxicological data ge nerated from surrogate test species, which are intended to be representative of broa d taxonomic groups, are used to extrapolate to potential effects on a variety of species (receptors) in cluded under these taxonomic groupings.

Acute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature are used to evaluate the potential direct and indirect effects of fluridone to aquatic and terrestrial receptors. This in cludes toxicity on the technical grade active14 of 80 ingredient, degradates, and when available, formulated products ( e.g. , “Six-Pack” studies). The open literature studies are identified th rough EPA’s ECOTOXicology (ECOTOX) database (USEPA 2009b), which employs a litera ture search engine for locati ng chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluation of both sources of data may also provide insight into the direct and indirect effects of fluridone on biotic communities from loss of species that are sensitive to the chemical and from changes in structure and functional

characteristics of the affected communities. Open literature data fr om ECOTOX on fluridone was searched on January 31, 2009. The data is be ing evaluated for possible quantitative and/or qualitative inclusion in the risk assessment.

A summary of the aquatic and terrest rial toxicity data used to de rive a preliminary evaluation of risk for fluridone is provided in Sections 4.1 and 4.2, respectively. In addition, a summary of ecological incidents associated w ith fluridone and a description of ecosystems potentially at risk are provided in Sections 4.3 and 4.4, respectively.

4.1. Effects to Aquatic Organisms

A summary of sensitive aquatic toxicity data from registrant-submitted studies and data available from the ECOTOX database is provided in Tabl e 4-1. Appendix B includes a table summarizing toxicity data submitted to the Agency. Fluridone is classified as slightly toxic to moderately toxic to aquatic organisms based on data for aq uatic vertebrates and inve rtebrates. Sublethal effects such as hyperactivity, irregular sw imming, loss of equilibrium, immobilization, discoloration, and prostration were observed in both vertebrate and invertebrate studies and in some studies at all treatment levels. Jumping, surfacing, and change in percent hematocrit were

observed in acute freshwater fish studies. Chro nic effects observed in aquatic studies include mortality, survival of fry, and hatching success. Toxicity data for aquatic plants have not been

submitted for fluridone. Several studies are availa ble in the open literature. The open literature studies will be evaluated for possible use in the risk assessment.

Most of the submitted studies were completed in the late 1970s and early 1980s. These studies are currently under review to dete rmine if the studies still meet guideline requirements. Special attention will be given to whether an accurate esti mate of exposure can be established. In many of the studies, precipitate was present and treatmen t levels exceeded the level of solubility. The

concentration was measured in most of the studi es; however, in some studies the water was not centrifuged or filtered to remove any pesticide that would be bound to organic matter or present as a precipitate. Therefore, the measured concentration likely exceeded the exposure

concentration. These studies will be used as s upplemental information as they do provide some information on whether toxicity may occur; howev er, due to the uncertainty in the exposure concentration, the studies cannot be used to fulfill guideline requi rements. Steep slopes were observed with much of the mortality occurring ne ar the level of solub ility (12.3 mg/L). The steep slopes indicate that a small change in conc entration may have a large impact on mortality.

N-methyl formamide (NMF) is a compound of t oxicological concern to mammals and the only degradate identified by the Health Effects Divi sion (HED) to be of toxicological concern (USEPA 2004b). It was found at a maximum of 74% of applied fluridone equivalents in a study examining photolysis in distilled water and a ma ximum of 36% applied fluridone equivalents in a study examining photolysis in lake water (MRID 00103326). Concentrations of NMF in15 of 80 photolysis studies increased over time, indicating that NMF could be stable to hydrolysis and photolysis (MRID 00103326). No toxicity data were submitted on the toxicity of NMF to aquatic species; however, open literature acute to xicity data for the fathead minnows and daphnia indicates that NMF is less toxi c than fluridone to these species. 2 Little information on the quality of these data is avai lable and these data cannot be used to discount risk. Therefore, toxicity data for NMF are needed to assess potentia l risk to aquatic organisms due to exposure to NMF. Toxicity studies will be requested for fish and invertebrates. No aquatic toxicity data were available in the public ECOTOX databa se when searched on April 21, 2009 (USEPA 2009b).

No aquatic toxicity data were available for 3-trifluoromethyl benzoic acid in the public ECOTOX database when searched on April 22, 2009 (USEPA 2009b). Data based on ECOSAR version 1.0 indicates that the toxicity endpoint s for aquatic organisms would range from 9-2706 mg/L, using the neutral organic acid chemical class (Appendix D). Th is suggests that the toxicity of this degradate is simila r to the toxicity of the parent.

Table 4-1. Summary of Sensitive Endpoints for Aquatic Organisms Under Consideration

for Use in the Risk Assessment for Fluridone a

Common Name (Species)

TGAI /TEP Duration End-point (effect) Mean

concentration in mg a.i./L (effect) Citation or

MRID/status or

review Acute Toxicity

Classification

Freshwater Vertebrates and Aquatic-phase amphibians

Rainbow Trout ( Salmo gairneri )

TGAI 96 hours LC 50 5.1 (mortality) 00103297 Acceptable Moderately Toxic

Rainbow Trout ( Salmo gairneri )

EP 96 hours LC 50 4.3 (mortality) 00103297 Moderately Toxic

Fathead Minnow (Pimephales promelas)

EP 96 hours LC 50 8.3 (mortality) 103297 Acceptable Moderately Toxic

Walleye (Sander vitreus)

TEP 96 hours LC 50 Near 1.8 b
(mortality) Paul et al. 1994 Preliminary Supplemental c Moderately Toxic

Fathead Minnow (Pimephales promelas)

TGAI Full Lifecycle NOAEC 0.48 (Survival of 30 day fry) 00103309 Acceptable NA

Chinook Salmon ( Oncorhyncus tshawytscha )

TGAI Early Life Stage NOAEC 0.43 (length) 45915601 Supplemental NA

Estuarine Marine Vertebrates
Sheepshead Minnow (Cyprinodon variegates)

TGAI 96 hours LC 50 near 10.7 b
(mortality) 00108837 Supplemental Slightly Toxic

Freshwater Invertebrates

2 The 96-hr LC 50 was > 10,000 mg/L for the fathead minnow based on nominal concentration and the 48-hr LC 50 was >500 mg/L for Daphnia magna based on nominal concentrations ( E.I. du Pont de Nemours and Company, LP., 2005).16 of 80 Common Name (Species)

TGAI /TEP Duration End-point (effect) Mean

concentration in mg a.i./L (effect) Citation or

MRID/status or

review Acute Toxicity

Classification

Midge ( Chironmous plumosus )

TGAI 48 hours LC 50 1.3 (immobility) 00103297 Preliminary Supplemental c Moderately Toxic

Waterflea (Daphnia magna)

TGAI 48 hours LC 50 5.2 (immobility) 00103297 Acceptable Moderately Toxic

Waterflea (Daphnia magna)

EP 48 hours LC 50 3.0 (immobility) 00103297 Acceptable Moderately Toxic

Waterflea (Daphnia magna)

TGAI 21 day life cycle NOAEL Near 0.2 b
(mortality) 00103297 Preliminary Supplemental c NA

Estuarine Marine Invertebrates
Pink Shrimp (Panaeus duorarum)

TGAI 96 hours LC 50 4.6 (mortality) 00112789 Acceptable Moderately Toxic

Pink Shrimp (Panaeus duorarum)

TEP 43.6% a.i. 96 hours LC 50 Near 2.4 b
(morality) 00103312 Supplemental Moderately Toxic

TGAI=technical grade active ingredient; TEP=typical end use product; LC 50 = median lethal concentration;

NOAEL=no observable adverse eff ect level; a.i. active ingredient a Data in this table may be used in the risk assessmen t, but it will not necessarily be used to calculate risk quotients. b This endpoint may only be used qualitatively in the assessment. For submitted studies, see the comments in Appendix B on why the quality of the data is not acceptable to use quantitatively. Fo r open literature studies, not enough information on the study procedures was available to determine if the study was conducted and data analyzed in a way that is consiste nt with current guideline requirements. c Preliminary classification of studies indicate s the studies have not been fully reviewed.

4.2. Effects to Terrestrial Organisms

A summary of sensitive terrestrial toxicity da ta from registrant-submitted studies and data available from the ECOTOX database is provid ed in Table 4-2. Appendix B includes a table summarizing toxicity data submitted to the Agency. Based on the available data, fluridone is classified as practically nontoxic to birds, mammals, and terrestrial invertebrates.

Acute, subchronic, and chronic t oxicity studies are available for mammals. These results are fully discussed in USEPA 2004c. In acute studi es, fluridone was shown to cause slight to moderate corneal dullness, iritis, and conjunctivitis. Subchronic studies resulted in increased incidence of hepatic centrilobula r hypertrophy, increased relative liver weights, and increased relative kidney weights in rats . In developmental studies, in creased incidence of abortions, decreased body weights, decrease d food consumption, increased in cidence of rudimentary ribs, and delayed ossification of sterne brae and pelvic girdle were obs erved. Chronic effects observed include small testes, ocular karatitis, and pale and granular kidneys. In metabolism studies, fluridone was rapidly and almost completely abso rbed into systemic circulation within 3 days and 78-97% radioactivity was recovered in the urin e and feces, with the majority of elimination17 of 80 in the feces. The primary components in feces were fluridone and fluridone metabolites resulting from ring hydroxylati on and N-demethylation.

No mortality was observed in acute avian studies. Submitted chronic avian studies are

considered invalid.

No terrestrial plant toxicity data were submitted. One open literature study was listed in ECOTOX for tomatoes and it will be evaluated for possible use in the risk assessment.

N-methyl formamide (NMF, CAS Number 123-39-7) is a fluridone metabolite formed by the photolysis of fluridone (MRID 00103326). It is the only degradat e identified by the health effects division (HED) as a degradate of toxicological concern (USEPA 2004b). One developmental toxicity study was reportedly ava ilable examining toxicity in mammals when the TRED was completed. NMF caused skeletal malf ormations in both rats and rabbits with a NOAEL of 10 mg/kg/day (USEPA 2004b). NMF is an investigational anti cancer drug that has undergone clinical trials (HSDB 200 2). Data are available on th e toxicity of NMF in the open literature (HSDB 2002). These data suggest that NMF is more acutely toxic than fluridone. 3
The quality of these data are unknown; however, the information doe s support the need for more information on the toxicity of NMF if potential e xposure is likely at high enough levels from the use of fluridone. Based on the preliminary TR EX run and the 10 mg/kg/day endpoint available for mammals, exposure to NMF may be high enough to elicit toxicity (Appe ndix C). No toxicity data were available to evaluate potential toxicity to birds. Therefore, avian toxicity data will be requested for NMF. No toxicity data were av ailable for NMF in the public ECOTOX database when searched on May 9, 2009 (USEPA 2009b).

No terrestrial toxicity data were available for 3-trifluorom ethyl benzoic acid in the public ECOTOX database when searched on April 22, 2009 (USEPA 2009b). Avian toxicity data will be requested so that risk to birds due to exposure to 3-trifl uoromethyl benzoic acid may be

evaluated.

Table 4-2. Summary of Sensitive Toxicity Endpoints for Terrestrial Organisms Under

Consideration for Use in Risk Assessment*

Common

Name (Species)

TGAI /TEP End-point Mean Concentration and Effect Citation or

MRID /

Status Acute Toxicity

Classification

Mammals

Rat (Rattus norvegicus)

TGAI LD 50 10,000 mg/kg-body weight (mortality) USEPA 2004b Practically

Nontoxic

Rabbit

TGAI Gestation day 6-18

NOAEL/

LOAEL 125/300 mg/kg/day (Increased incidence of abortions in parent, 4/14

aborted between days 20 and 25 of gestation, decreased body weight) 00103302/

USEPA 2004c NA

3 Reported oral acute LD 50 values for mice were 2600 mg/kg and 4000 mg/kg in rats (HSDB 2002). These data have not been reviewed and the quality of the data is unknown.18 of 80 Common

Name (Species)

TGAI /TEP End-point Mean Concentration and Effect Citation or

MRID /

Status Acute Toxicity

Classification

Rat (Rattus norvegicus)

TGAI 3 generation reproduction

NOAEL/

LOAEL 36/112 mg/kg/day (decreased offspring body weight, 90% of control) 00103304/

USEPA 2004c NA

Rat (Rattus norvegicus)

TGAI 2 year

NOAEL/

LOAEL 7.65/25.15 mg/kg/day (body weight 92% of control)

25.15/80.8 mg/kg/day (Body weight was 59- 89% of control, and increased incidence of small

testes, enlarged and granular kidneys, opaque,

cloudy ulcerated eyes, and skin nodules and

masses observed. The effects were dose related.) 00103305/

USEPA 2004c NA

Birds**

Bobwhite Quail (Colinus virginianus)

TGAI Highest

Dose Tested 2000 mg/kg-bw (no mortality) 00121686/ Acceptable Practically

Nontoxic

Bobwhite Quail (Colinus virginianus)

TGAI 8-day Highest

Conc. Tested 4390 mg/kg-diet (no mortality)

00121687/ Acceptable NA

Terrestrial Invertebrates
Honey Bee (Apis mellifera)

TEP 33.3 Highest

Dose Tested 362.58 μg/bee (no mortality) 00103295/ Acceptable Practically

Nontoxic

Earthworm (Eisenia fetida)

TGAI 14-day Highest

Dose Tested 102.6 mg/kg (no mortality attributed to treatment) 00121692/ Supplemental NA

TGAI=technical grade active ingredient; TEP=typical end use product; LD 50 = median lethal dose; NOAEL=no observable adverse effect level; a.i. ac tive ingredient; NA = not applicable * Data in this table may be used in the risk assessment, but it will not necessarily be used to calculate risk quotients. **Birds represent surrogates for terr estrial-phase amphibians and reptiles.

4.3. Incident Database Review

A preliminary review of the Ec ological Incident Information System (EIIS) maintained by the Agency’s Office of Pesticide Programs (OPP) indicates a total of 12 reported ecological

incidents associated with the use of fluridone occurred. Nine incidents we re reported for aquatic animals and three are reported for plants. All incidents were reported between 2000 and 2005. Seven of the incidents were associated with regi stered uses of fluridone , three were associated

with uses where it was undetermined if the us e was a registered use, and one incident was associated with a misuse. The certainty that the incidents were associated with fluridone exposure was considered possible for two incide nts and probable for nine incidents. One incident was reported where fluridone was a c ontaminant in another pesticide formulation (I020064-001). This incident was not included in the table. The in cident data that are available19 of 80 indicate that exposure pathways ar e complete and that exposure leve ls are sufficient to result in field-observable effects in fish, especially when a liquid formulation is used. The maximum use rate (0.150 mg/L) is approximately 10-100 times lowe r than the acute toxicity values observed in aquatic toxicity studies on fish (1.8 - >12.3 mg/L). We speculate that the incidents could be explained by the following.

• The submitted studies on acute toxicity to fi sh are supplemental due to the inability to identify the exposure concentrati on. It is possible the true expos ure concentration is less than that reported in the studies.

• Variation in the sensitivity of fi sh to fluridone is expected in the natural environment due to a number of factors including inters pecies and intraspecies variation.

• Many of the incidents were observed for liquid fo rmulations. The concentration of fluridone is higher in a localized area when it is first ap plied and before it is di stributed throughout the water body. This higher concentration may be more pronounced for liquid applications than for the slow release pellet form ulations. The observed incident s could be due to fish being exposed to fluridone before it is evenly distributed throughout the water column.

Table 4-3. Summary of Incidents Reported in the Ecological Incident Information System (EIIS) for Fluridone

Incident ID

Source Formulation/ Application

Method Use

Site Legality/ Certainty Month/

Year State Total Magnitude

I014700-001/ CA Dept. of

Fish & Game Sonar/

EC/

NR Lake Registered Use/

Possible 09/

2003 CA Over 6 threadfin shad were found dead

near the time of fluridone use to control hydrilla. Fluridone was measured in the gill of fish.

I0013560-

001/

SePRO Sonar AS/

FC/

NR NR Misuse 1qt/acre/

Probable 09/

2002 IN 50-100 bluegill sunfish and one bass were found dead 5 days after fluridone application.

I016555-002/

SePRO Sonar/

NR/ Spray Pond Undetermined/

Probable 05/

2005 TX Applied to pond by homeowner using hand pump sprayer. Fish died 3 weeks later. 10 catfish, 8-10 bass, and 1 grass carp died.

I016555-009/

SePRO Sonar/

NR/

NR Pond Undetermined/

Probable 06/

2005 OH Over 500 fish died two days after

fluridone treatment

I016555-010/

SePRO Sonar/

NR/

NR Pond Registered Use/

Probable 06/

2005 NC 2 carp and bass died 16 days after

fluridone treatment

I016846-004/

SePRO Sonar/

EC/ Direct App. Pond Registered Use/

Probable 07/

2005 300 sunfish, 30 catfish, and 50 largemouth bass died 2 days after fluridone application

I016846-006/

SePRO Avast/

SC/ Injection Pond Registered Use/

Probable 08/

2005 TX 350 tilapia died one day after fluridone treatment at a target concentration of 50 ppb. Bass, catfish, and other species were

not affected.

I017148-002/

SePRO Sonar AS/

FC/ Hand sprayer Pond Registered Use/

Probable 10/

2005 KY 100 catfish, 50 bass, and 50 bluegill sunfish died after treatment of pond at a target concentration of 60 ppb.20 of 80 Incident ID

Source Formulation/ Application

Method Use

Site Legality/ Certainty Month/

Year State Total Magnitude

I017148-003/

SePRO Sonar AS/

FC/ Spray Pond Registered Use/

Probable 10/

2005 WV 100 bluegill, 40 bass, 25 catfish, and 6 grass carp died 3-5 days after treatment

with fluridone.

I011930-001/

SePRO Sonar AS/

NR/

NR Pond Undetermined/

Probable 10/

2000 NC A one acre pond was treated with fluridone in October 2000. The following March pond water was used to irrigate

strawberries with no adverse effects observed. In June, pond water was used to irrigate 2 acres of tomatoes and damage was reported.

I016846-002/

SePRO Sonar/ Liquid &

Pellet/

NR Pond Registered Use/

Possible 07/

2005 OH Damage to a willow tree was reported by homeowner who treated pond every year with SONAR for many years.

NR=not reported, Dept.=Department; App.= application; EC =emulsifiable concentrate; SC =soluble concentrate; FC

= flowable concentrate

4.4. Ecosystems Potentially at Risk

The ecosystems at risk are often extensive in scop e; therefore, it may not be possible to identify specific ecosystems during the development of a nation-wide ecological risk assessment. However, in general terms, terrestrial ecosystems potentially at risk could include the areas that are immediately adjacent to treated water that ma y receive drift or runo ff during flooding. Areas adjacent to the treated water could include cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats and other uncultivated areas. Also, areas that are irriga ted with treated water ma y also be at risk.

Aquatic ecosystems potentially at risk include tr eated water bodies and water bodies adjacent to or down stream from, the treated water and coul d include impounded bodies such as ponds, lakes and reservoirs, or flowing waterway s such as streams or rivers. For uses in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries.

5. Assessment Endpoints

Assessment endpoints are defined as “explicit expressions of the actual envir onmental value that is to be protected” (USEPA 1998). Selection of the asse ssment endpoints is based on valued entities ( e.g., fish, birds), the ecosyst ems potentially at risk ( e.g., waterbodies, riparian vegetation, and upland habitats), the migration pathways of fluridone ( e.g., runoff, spray drift,

etc. ), and the routes by which ecological receptors are exposed to fluridone ( e.g., direct contact,

etc. )

.

Assessment endpoints for fluridone include direct toxic effects on the survival, reproduction, and growth of the receptors, as well as indirect e ffects, such as reduction of the prey base or modification of habitat. Each assessment endpoint requires one or more “measures of ecological effect,” defined as changes in the attributes of an assessment endpoint or changes in a surrogate entity or attribute in response to exposure to a pesticide. Specif ic measures of ecological effect21 of 80 are generally evaluated based on acute and chronic toxicity information from registrantsubmitted guideline tests that are performed on a limited number of organisms. Additional ecological effects data from the open literature will also be considered.

6. Conceptual Model

For a pesticide to pose an ecological risk, it mu st reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological recepto r. 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, an d a feasible route of exposure.

The conceptual model for fluridone provides a wr itten description and visual representation of the predicted relationships betw een fluridone, potential routes of exposure, and the predicted effects for the assessment endpoint. A conceptual model consists of two major components: risk hypothesis and a conceptual diagram (USEPA 1998).

6.1. Risk Hypothesis

A risk hypothesis describes the predicted re lationship among the stre ssor, exposure, and assessment endpoint response along with the rationa le for their selection. For fluridone, the following overall ecological risk hypothesis is being employe d for this ecological risk

assessment:

Based on the application methods, mode of ac tion, fate and transport, and the sensitivity of non-target aquatic and te rrestrial species, fluridone and its degradates, NMF and 3- trifluoromethyl benzoic acid, have the poten tial to reduce survival, reproduction, and/or growth in non-target terrestr ial and aquatic organisms when used in accordance with the

current label. These non-t arget organisms include fede rally listed threatened and endangered species as well as non-listed species.

The specific exposure routes quantitatively evalua ted include, water concentrations, spray drift, drinking water, and irrigation wa ter. The following hypotheses re flect these exposure pathways.

• Fluridone, NMF, and 3-trifluoromethyl benzoi c acid concentrations in water have the potential to reduce survival, reproduction, a nd/or growth of aquatic vertebrates, invertebrates, and plants.

• Fluridone, NMF, and 3-trifluormethyl benz oic acid residues on plants and other dietary surfaces deposited with spray drif t have the potential to reduce survival, reproduction, and/or growth of terrestri al organisms such as birds, mammals, invertebrates, and plants.

• When water treated with fluri done is used as irrigation wa ter, residues of fluridone, NMF, and 3-trifluoromethyl benzoic acid have the potential to reduce survival, reproduction, and/or growth of terrestri al organisms such as birds, mammals, invertebrates, and plants.22 of 80 • Survival, reproduction, and/or growth ma y be reduced in birds, mammals, and amphibians exposed to fluridone, NMF, and 3-trifluoromethyl benzoic acid in drinking water.

6.2. Conceptual Diagram

The environmental fate properties of fluridone indi cate that runoff, spray drift, volatilization and direct spray represent potential transport mechanisms of fluri done to aquatic and terrestrial habitats where non-target organism may be exposed. These transport mechanisms ( i.e ., sources) are depicted in the conceptual models below (Figure 6-1 and Figure 6-2) along w ith the receptors of concern and the potential attrib ute changes in the receptors due to exposures of fluridone.

Fluridone will enter the aquatic e nvironment via direct application. Aquatic organisms in water will be exposed to fluridone in both the water column and in sediment. The open literature K OC values indicate that fluridone concentrations in sediment coul d be a relevant exposure pathway (BLM 2005). Terrestrial organisms that drink trea ted water will also be exposed. Treated water used as irrigation water may result on residues on plants and dietary item s for other terrestrial organisms. Finally, spray drift that may occur during treatment of wate r may result in residues on plants and on dietary items for birds and mammals.

Aquatic and terrestrial exposure to NMF and 3-trifluormethyl be nzoic acid may occur with the degradation of fluridone over time. The c oncentration may be prolonged as fluridone concentrations will be maintained and will provide a continuous source of degradates.23 of 80 Figure 6-1. Conceptual Model Depicting Ex posure Pathways and Potential Risks to Aquatic Organisms from the Use of Flur idone to Control Aquatic Vegetation. Dashed lines indicate routes of exposure consider ed of lower importance for fluridone. Fluridone, NMF, and 3-trifluoromethyl benzoic

acid

Fluridone Applied to Water as liquid or pellet

Sediment/ Suspended

Solids Plant Matter Water Column

Aquatic Vertebrates

and Invertebrates Nonvascular Plants

Vascular Plants Aquatic Vertebrates

and Invertebrates Source/Transport Pathways

Source/Exposure

Media

Ex p osure

Receptors

Reduced Survival, Growth, or Reproduction Reduced Survival, Growth, or Reproduction Attribute

Stresso r s

Reduced Survival, Growth, or Reproduction Uptake/Gills or

inte g ument Uptake/Gills or

Inte g ument Uptake/cell, roots, leaves In g estion24 of 80 Figure 6-2. Conceptual Model Depicting Ex posure Pathways and Potential Risks to Terrestrial Organisms from the Use of Flur idone to Control Aquatic Vegetation. Dashed lines indicate routes of exposure consid ered of lower importance for fluridone.

7. Analysis Plan

In order to address the risk hypot hesis, the potential for adverse effects on the environment is estimated. The use, environmental fate, and ecol ogical effects of fluridone are characterized and integrated to assess the risks. This is accomp lished using a risk quotient (ratio of exposure

concentration to effects concentr ation) approach. Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient-based approach does not provide a quantitative estimate of likelihood and/or magnitude of an adverse effect. However, as outlined in the Overview Document (USEPA 2004d), the likelihood of effects to individual organisms from particular uses of fluridone is estimated using the probit dose-respon se slope and either the level of concern (discussed below) or the actual calculated risk quotient value. Residues in Water

Terrestrial Vertebrates

and Invertebrates Terrestrial Plants Source/Transport Pathways

Source/Exposure

Media

Ex p osure

Rece p tors

Attribute Direct Application of Fluridone as Liquid or Pellet Stressors

Ingestion Direct Contact/Root Uptake Ingestion on dietary items

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in primary productivity Reduction in prey Shift in community composition Volatization and Redeposition

Leaching/

Percolation Groundwater

Habitat integrity Reduction in primary productivity

Reduced cover Community change
Modification of PCEs related to

habitat Residues in Irrigation Water or Spray Drift To

Terrestrial Environment Fluridone, NMF, 3-trifluoremethyl benzoic acid25 of 80 This analysis plan will be re visited and may be revised dependi ng upon the data available in the open literature and the information submitted by the public in response to the opening of the Registration Review docket.

7.1. Stressors of Concern

As discussed above, fluridone degradates measur ed in photolysis studie s at greater than 10% applied equivalents include NMF, 3-trifluoromet hyl benzoic acid, and be nzoic acid. Benzoic acid will degrade rapidly in the environment and th e toxicity is less than that of the parent (HSDB 2005). Based on previous assessments ( e.g ., USEPA 2004b), NMF is a degradate of toxicological concern. Additionally , ECOSAR data indicates that 3-trifluromethyl benzoic acid has a similar toxicity to fluridone to aquatic or ganisms (Appendix D). Therefore, the focus of the assessment is expected to be the parent, fluridone, NMF, and 3-trifluoromethyl benzoic acid. However, the Agency will review all available cu rrent degradate ecotoxicity data to identify any

additional stressors of concern for the assessment.

In its ecological risk assessments, the Agency does not routinely include an evaluation of mixtures of active ingredients, either those mi xtures of multiple activ e ingredients in product formulations or those in the applicator’s tank. In the case of the product formulations of active ingredients (that is, a registered product contai ning more than one active ingredient), each active ingredient is subject to an indi vidual risk assessment for regula tory decision regarding the active ingredient on a particular use site. If eff ects data are available for a formulated product containing more than one active ingredient, the da ta may be used qualitatively or quantitatively in accordance with the Agency’s Overview Document and the Services’ Evaluation Memorandum (USEPA 2004d; U.S. FWS/NMFS 2004).

Available toxicity data for environmental mixtur es of fluridone with ot her pesticides will be presented as part of the ecological risk assessment. 4 It is expected that the toxic effect of fluridone, in combination with othe r pesticides used in the environm ent, is likely to be a function of many factors including but not necessarily limited to: (1) th e exposed species, (2) the cocontaminants in the mixture, (3) the ratio of fluridone and co-contamin ant concentrations, (4) differences in the pattern and duration of expos ure among contaminants, and (5) the differential effects of other physical/chemical charac teristics of the r eceiving waters ( e.g. organic matter present in sediment and suspended water). Quan titatively predicting the combined effects of all these variables on mixture toxicity to any given taxa with conf idence is beyond the capabilities of the available data and methodologies. However, a qualitative discussion of implications of the available pesticide mixture effects data on the confidence of risk assessment conclusions will be addressed as part of the uncertainty analysis.

7.2. Measures of Exposure

In order to estimate risks of fluridone exposures in aquatic and terres trial environments, all exposure modeling and resulting risk conclusion s will be made based on maximum application rates for fluridone. Measures of exposure are ba sed on aquatic and terrestrial models that predict

estimated environmental concentr ations of fluridone using maxi mum labeled application rates

4 No data on mixtures with fluridone, other than testing on formulations, have been found.26 of 80 and methods, as well as any mitigation meas ures specifically indicated on the label ( e.g. spray drift buffers). Aquatic exposures will be estim ated using data from the aquatic dissipation

studies and other environmental fate studies. Th e model used to predict terrestrial EECs on food

items is T-REX. The model used to derive EEC s relevant to terrestrial and wetland plants is

TerrPlant. A standard model is not available to estimate exposure to birds and mammals to residues in drinking water or to terrestrial organisms due to expos ure to residues of fluridone in irrigation water; however, a preliminary method wa s used in a recent ecological risk assessment (USEPA 2008a).

7.2.1 Aquatic Organisms

A standard model is not availabl e to estimate residues of fluridone applied directly to water over time. Exposure will be estimated using data fr om the aquatic dissipati on studies. The values estimated using the dissipation studies may be br acketed using aerobic aquatic degradation rates and photolysis degradation rates. As the instructi ons indicate that concentrations in water must

be maintained over time and there is no limit on th e application interval, the target application rate will be used as a starting point for exposure estimates. Total toxic residues of fluridone and 3-trifluoromethyl benzoic acid will be estimate d. Additionally, data on NMF will be evaluated to determine whether it is appropriate to estim ate exposure to total toxic residues or to NMF alone. Although NMF is believed to be toxic, is not expected to hydrolyze since amides hydrolyze very slowly at environmental conditio ns. Since NMF’s vapor pressure is 0.25 mm Hg, it appears that volatility may be a dissipation route.

7.2.2 Terrestrial Organisms

Terrestrial wildlife may be exposed to fluridone via the followi ng pathways: 1) ingestion of pellets from aerial application to water; 2) drinking treated water; and 3) consumption of fluridone on food items via spray drift applic ations. Terrestrial exposure to NMF and 3- trifluoromethyl benzoic acid may also be estimated.

7.2.2.a Residues on Terrestrial Invertebrates and Dietary Items of Terrestrial Organisms
Exposure estimates for terrestrial an imals assumed to be in the target area or in an area exposed to spray drift are derived using the (T errestrial R esidue EX posure model) T-REX model. This model incorporates the Kenaga nom ograph, as modified by Fletcher et al. (1994), which is based on a large set of actual field residue data. The upp er limit values from the nomograph represent

the 95 th percentile of residue values from actual fi eld measurements (Hoerger and Kenaga 1972).

The Fletcher et al. (1994) modifications to the Kenaga nomograph are based on measured field residues from 249 published research papers, incl uding information on 118 species of plants, 121 pesticides, and 17 chemical classes. For aerial app lications of pellet or granular formulations, an estimation of loadings of pesticid e per unit area is calculated using the T-REX model. No drift is assumed for ground applications of pellet and gr anular formulations. For broadcast spray applications, the T-REX model is also used to predict dietary exposure of birds and mammals to

fluridone residues on foliar su rfaces and insects using the Ke naga nomogram as modified by Fletcher (Hoerger and Kenaga 1972; Fletcher et al. 1994). The residues estimates on insects are

also used to estimate terres trial exposure to insects.27 of 80 7.2.2.b Drinking Water Exposure of Birds and Mammals
A model to estimate exposure of birds and mamm als to residues in drinking water is not currently available. A preliminary method to estim ate exposure to residues in drinking water has been used in previous risk assessments and is based on body weight-specific consumption rates

and the concentration of fluridone in wate r bodies (USEPA 1993; USEPA 1998; USEPA 2008b). This preliminary approach may be used to estim ate exposure of terrestrial birds and mammals to fluridone, NMF, and 3-trifluoromethyl benzoi c acid in drinking water. Drinking water concentrations will be based on those predicted for aquatic exposure.

7.2.2.c Spray Drift Residues on Terrestrial Plants
Estimated Environmental Concentrations (EECs) for terrestrial plants inhabiting dry and wetland areas are derived using TerrPlant. This model uses estimates of pesticides in runoff and in spray drift to calculate EECs. EECs are based upon solubility, application rate, and minimum incorporation depth.

7.2.2.d Residues in Water Used for Irrigation
A model to estimate exposure of terrestrial organi sms to residues of fluridone in irrigation water is not currently available; how ever, a preliminary method was us ed in a recent ecological risk assessment (USEPA 2008a). This method will be evaluated to determine if it is appropriate to

assess risk of residues of fluridone in ir rigation water to terre strial organisms.

7.2.2.e Terrestrial Exposure to NMF and 3 -trifluoromethyl benzoic acid
Terrestrial exposure to NMF and 3- trifluoromethyl benzoic acid will be estimated if exposure is likely to be high enough to elicit toxicity. Terre strial exposure to degradates will be estimated using the same models used to estimate expos ure to the parent compound; however, the amount of degradates will be estimated based on the amount observed in the environmental fate studies.

7.3. Measures of Effect

Ecological effects data are used as measures of di rect and indirect effects to biological receptors. Data are obtained from registrant-submitted studies or from literature studies identified by

ECOTOX. The ECOTOX database (USEPA 2009b) provides more eco logical effects data in an attempt to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potential chemical mixture toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX was created and is maintained by the US EPA, Office of Research and Development,

and the National Health and Environmental Ef fects Research Laboratory's Mid-Continent Ecology Division.

Information on the potential effects of fluridone on non-target animals is al so collected from the Ecological Incident Information System (EIIS). 5 The EIIS is a data base containing adverse effect (typically mortality) reports on non-targ et organisms where such effects have been associated with the use of pesticides.

5 http://www.epa.gov/oppefed1/genera l/databasesdescription.htm#eiis28 of 80 Where available, sublethal effects observed in both registrant-submitted and open literature studies will be evaluated qualitatively. Such effects may include behavioral changes ( e.g. , lethargy and changes in colora tion). Quantitative assessments of risks, though, are limited to those endpoints that can be di rectly linked to the Agency’s assessment endpoints of impaired survival, growth, and reproduction.

The acute measures of effect used fo r animals in this assessment are the LD 50 , LC 50 and EC 50

. LD stands for "Lethal Dose", and LD 50 is the amount of a material, given all at once, that is

estimated to cause the death of 50% of the test organisms. LC st ands for “Lethal Concentration”

and LC 50 is the concentration of a chemical that is estimated to kill 50% of the test organisms.

EC stands for “Effective Concentration” and the EC 50 is the concentration of a chemical that is estimated to produce a specific effect in 50% of the test organisms. Endpoints for chronic measures of exposure for listed and non-lis ted animals are the NOAEL/NOAEC and NOEC.

NOAEL stands for “No Observed-Adverse-Effect-Level ” and refers to the hi ghest tested dose of a substance that has been reported to have no harm ful (adverse) effects on test organisms. The NOAEC ( i.e. , “No-Observed-Adverse-Effect-Concentration” ) is the highest test concentration at

which none of the observed effects were statistically different fr om the control. The NOEC is

the No-Observed-Effects-Concentration. Fo r non-listed plants, only acute exposures are assessed ( i.e. , EC 25 for terrestrial plants and EC 50 for aquatic plants); for listed plants either the

NOAEC or EC 05 is used.

In the absence of taxon-specific da ta, the assessment of risk fo r direct effects to non-target organisms makes the assumption that toxicity of fl uridone to birds is similar to terrestrial-phase amphibians and reptiles. The same assumption is made for fish and aquatic-phase amphibians.

In the absence of data for either acute or chroni c effects, the conservative assumption will be to presume that fluridone is toxic.

Fluridone can form NMF and 3-trifluormethyl benzoic acid with exposure to light (MRID 00103326). NMF may be more toxic to receptors than parent fluridone (USEPA 2004b, HSDB 2002) and 3-trifluormethyl benzoic acid may have a similar toxicity to fluridone (Appendix D). Open literature data for NMF and 3-trifluormethyl benzoic acid will be evaluated for possible

use in the risk assessment. If no data are available specific to NMF and 3-trifluoromethyl benzoic acid, data on chemicals with a similar structure may be used to evaluate risk.

7.4. Integration of Exposure and Effects

Risk characterization is the integration of e xposure and ecological effects characterization to determine the potential ecological risk from the us e of fluridone as an aquatic herbicide and the

likelihood of direct and indirect e ffects to non-target organisms in a quatic and terrestrial habitats. The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non-target spec ies. For the assessment of flur idone risks, the risk quotient (RQ) method is used to compare exposure and m easured toxicity values. EECs are divided by acute and chronic toxicity values . The resulting RQs are then compared to the Agency’s Levels of Concern (LOCs) (USEPA 2004d). These criteria are used to indicate when fluridone’s uses, as directed on the label, have the potential to ca use adverse direct or indi rect effects to non-target organisms. In addition, incident data from the EIIS will be considered as part of the risk

characterization.29 of 80 7.5. Deterministic and Probabilistic Assessment Methods

The quantitative assessment of risk will primarily depend on the deterministic point-estimate based approach described in the risk assessment. An effort will be made to further qualitatively describe risk using probabilistic tools that the Agency has developed. These tools have been reviewed by FIFRA Scientific Advisory Panels ( http://www.epa.gov/sc ipoly/sap/index.htm ) and have been deemed as appropriate means of refi ning assessments where deterministic approaches

have identified risks.

7.6. Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to Federally-listed th reatened and/or endangere d (listed) species from registered uses of fluridone. This assessment w ill be conducted in accordance with the Overview Document (USEPA 2004d), provisions of the ESA, and the Services’ Endangered Species

Consultation Handbook (U.S. FWS/NMFS 1998).

The assessment of effects associated with the registration of fluri done is based on an action area.

The action area is considered to be the area directly or indirectly affected by the federal action, as indicated by the exceedance of Agency Levels of Concern (LOCs) used to evaluate direct or indirect effects. The Agency’s approach to defining the action area under the provisions of the Overview Document (USEPA 2004d) considers the results of the risk assessment process to

establish boundaries for that action area with the understandi ng that exposures below the Agency’s defined LOCs constitute a no-effect threshold. For th e purposes of this assessment,

attention will be focused on the footprint of the action ( i.e ., the area where flur idone application occurs), plus all areas where offsite transport ( i.e ., spray drift, runoff, etc. ) may result in potential exposure that exceeds the Agency’s LOCs. Specific measures of ecological effect that define the action area for listed species include any direct and indi rect effects and/or potential modification of its critical habitat, including reduction in survival, growth, and reproduction as well as the full

suite of sublethal effects availabl e in the effects literature. Ther efore, the action area extends to a point where environmental exposures are below any measured lethal or sublethal effect threshold for any biological entity at the whole organism, organ, tissue, and cellular level of organization. In situations where it is not possible to determin e the threshold for an observed effect, the action area is not spatially limited and is assumed to be the entire United States.

7.7. Drinking Water Assessment

A drinking water assessment will be conducted to support future human health risk assessments of fluridone. The drinking water assessment will incorporate model estimates of fluridone in

surface water. Since no PRZM scen ario is available for aquatic pe sticides, and in order to assess potential exposures for aquatic herbicides, a fi rst approximation of a drinking water EEC was modeled assuming direct applicati on to the index reservoir. EFED developed an approach using a simple spreadsheet model that incorporates de gradation based on an acceptable aerobic aquatic metabolism, photolysis, hydrolysis studies, and flow through the Index Reservoir.

This scenario includes the assumption that flurid one or NMF is uniformly applied to the index

reservoir with a surface area of 5.3 hectares a nd a volume of 144,000,000 liters. In this model,30 of 80 the 90 day average and annual mean concentrat ions were calculated assuming first-order dissipation from aerobic aquatic degradation, aqua tic photolysis, hydrolysis , and reservoir flowthrough. A conservative approach will be used that accounts for possible reapplication of fluridone to the water body. The label indicat es that fluridone should be reapplied if

concentrations fall below an effective level but does not provide a minimum application interval.

The scenario evaluated with the simple spreadsheet model approach will rely on an interpretation of the label for aquatic weed control requiring a target rate for fluridone use based on target concentration and not application rate. In order to account for th is interpretation it will be assumed that fluridone will be applied at a rate to meet the target concentration. This assumption is applicable across all water bodies since the targ et rate is based on a rate shown in the Master Label and is independent of water body geomet ry/volume. This scenario will include the assumption of uniform application across the en tire water body without any setbacks from drinking water intakes.

7.8. Preliminary Identification of Data Gaps

7.8.1 Fate

All environmental fate data requirements have b een satisfied for the use of fluridone as an aquatic herbicide in lakes and ponds. Table 7-1 summarizes the submitted environmental fate studies and the submitted environmental chemistry methods are discussed below.

Table 7-1. Summary of Environmental Fate Studies

Guideline Description MRID Classification Data Gap?

835.2120 Hydrolysis MRID#

30257 Acceptable No

835.2240 Photodegradation in water MRID#

103326 Acceptable No

835.4100 Aerobic soil metabolism MRID#

135217 Acceptable No

835.4200 Anaerobic soil metabolism MRID#

135217 Acceptable No

835.4300 Aerobic Aquatic Metabolism MRID#

44154801 Acceptable No

835.4400 Anaerobic Aquatic

Metabolism MRID#

1033327 Acceptable No

835.1230

835.1240 Leaching and adsorption/ desorption MRID#

44138501 Acceptable No

835.6200 Aquatic (Sediment) Field Dissipation MRID#

162339 Acceptable No

165-4 Bioaccumulation in Fish MRID#

162775 Acceptable No31 of 80 There are four possible environmental chemistry methods available for fluridone and NMF. The paper “Determination of Fluridone in So il and Hydrosoil by High Pressure Liquid Chromatography” prepared by Li lly Research Laboratories (M RID 159966 – No independent lab verification), “Residues of Fluri done and Its Major Metabolites in Crayfish from Ponds Treated with the Aquatic Herbicide S onar” prepared by Lully Research laboratories (MRID 162775 – No independent lab verification), “Determination of Fluridone in Wate r by High –performance Liquid Chromatography Following Extraction with Sep-Pak C18 Cartridges” prepared by Lilly Research Laboratories (MRI D 40485901- Independent Lab Ve rification done by Elanco Products Co. Lab # 591416), and “Gas Chromatography Determination of Residue Levels of Nmethylformamide in Water” prepared by Lilly Research Laboratories (MRID 40485902- Independent Lab Verification done by Elanco Products Co. Lab # 591416).

The MRIDs 159966 and 162775 need to be validate d. EFED does not recommend a validated soil method be requested at this time; however, if a state requests a validated method or a risk concern arises due to potential exposure to residu es in soil or sediment, a validated method may be requested at that time. The other two methods, MRIDs 40485901 and 40485902, have yet to be reviewed. Therefore, they may be acceptable ECMs for water.

7.8.2 Effects

Although many submissions have been made to pr ovide data on the effects of fluridone to aquatic and terrestrial organisms, several data gaps still exist. Table 7-2 and Table 7-3

summarize the data submitted and data needed to assess the ecological risk of the use of fluridone to control aquatic vegetation. All studies shoul d be conducted at high enough concentrations to predict toxicity at predicted exposure levels. Data gaps are listed below.

Terrestrial Organisms

• avian acute oral toxicity (Guideline 850.2100) study with a passerine species

• avian reproduction studies (Guideline 850.2300) with an upland game bird and waterfowl with the technical grade active ingredient (TGAI)

• honeybee acute contact toxicity (Gui deline 850.3020) test using the TGAI

• terrestrial plants s eedling emergence and vegetative vigor studies (Guideline 850.4100 and 850.4150) using EPs representative if current TEPs

Aquatic Organisms

• acute toxicity to freshwater fish (G uideline 850.1075) for one coldwater and one warmwater species using EPs re presentative if current TEPs

• estuarine/marine acute toxicity to fish (Guideline 850.1075) using the TGAI and EP representative of current TEPs,

• freshwater invertebrate acute toxicity (Guideline 850.1010) us ing EPs representative if

current TEPs

• estuarine/marine invertebrate acute toxici ty (Guideline 850.1025) examining oyster shell deposition with TGAI and using EP s representative if current TEPs

• freshwater invertebrate full lifecy cle study (850.1300) with the TGAI32 of 80 • estuarine/marine fish full life cycle (Guideline 850.1500)

• whole sediment chronic invertebrate freshwater

• aquatic plant growth studies (Guideline 850.4400 and 850.5400) using EPs representative

if current TEPs

Studies for the Degradate, NMF

• avian acute oral toxic ity (Guideline 850.2100)

• avian reproduction study (Guideline 850.2300)

• acute toxicity to freshwater fish (G uideline 850.1075) for one coldwater and one warmwater species

• freshwater invertebrate acute toxicity (Guideline 850.1010)

• Freshwater invertebrate life cycle: Daphnid (Guideline 850.1075)

• Freshwater Fish Early-Life Stage and Estu arine/Marine Early-Life Stage (Guideline 850.1400)

Studies for the Degradate, 3- trifluromethyl benzoic acid

• avian acute oral toxic ity (Guideline 850.2100)

• avian reproduction study (Guideline 850.2300)

An estuarine marine inverteb rate lifecycle study (Guideline 850.1300) may be needed if the

acute LC 50 < 1 mg/L or the EEC is ≥ 0.01 of acute LC 50 (USEPA 2007b)

.

Data gaps for the parent compound are discussed below and summarized in Table 7-2 and Table 7-3. Data gaps for the degradate, NMF and 3- trifluoromethyl benzoic acid, are not included in

Table 7-2 and Table 7-3.

Table 7-2. Available Ecological Effects Data for Terrestrial Animals Exposed to Fluridone

Guideline Description Species TGAI

or TEP MRID/

Accession Classification Data Gap? Comments

850.2100

Avian oral

toxicity 1 Bobwhite Quail TGAI 00121686 Acceptable Yes*

Bobwhite

Quail TGAI 00121687 Acceptable 850.2200 Avian dietary toxicity 2 Mallard Duck TGAI 00121687 Acceptable No *Avian acute oral toxicity data

are not available for passerines, which are required

under the new 40 CFR Part 158. An acute oral toxicity study using passerines must be

submitted to fulfill this data requirement.33 of 80 Guideline Description Species TGAI

or TEP MRID/

Accession Classification Data Gap? Comments

Bobwhite

Quail TGAI 00103293 Invalid 850.2300

Avian reproduction 2 Mallard Duck TGAI 00103294 Invalid Yes**

850.3020 Honeybee

acute contact

toxicity 3 Honeybee TEP 00103295 Acceptable Yes***

1 Data are required on one passerine species and either one waterfowl species or one upland game bird species 2 Data are required on waterfowl and upland game bird species. 3 Data using the TGAI are required to support all outdoor end-use product uses

Table 7-3. Available Ecological Effects Data for Aquatic Animals Exposed to Fluridone

Guideline Number Description Species TGAI/

TEP MRID/

Accession Classification Data Gap? Comments

Rainbow

Trout TGAI 00103297 Acceptable (6 studies)

Supplemental

(3 studies)

Rainbow

Trout EP 00103297 Acceptable

Channel

Catfish TGAI 00103297 Acceptable (1 study)

Supplemental (9 studies)

Channel

Catfish EP 00103297 Supplemental

Bluegill

Sunfish TGAI 00103308 Supplemental

Bluegill

Sunfish EP 00103306 Supplemental

Bluegill

Sunfish EP 00103297 Acceptable

Bluegill

Sunfish TGAI 00121689 Invalid

Bluegill

Sunfish TGAI 00103297 Supplemental

Rainbow

Trout TGAI 00121690 Supplemental

Rainbow

Trout EP 00103307 Supplemental 850.1075

Freshwater fish –

Acute toxicity

Data needed for 1

coldwater species and 1 warmwater species. Data needed for TEP if applied directly to water,

maximum EEC ≥ 0.5 LC 50 , or end product enhances toxicity

Fathead

Minnow TGAI 00103297 Supplementalqualitative 1 Yes Data are needed on EPs that are representative of current TEPs. The registrant should provide information indicating whether studies examining toxicity to EPs are applicable to current products or submit studies examining exposure EPs that are representative of current TEPs for

a coldwater and warmwater species. The tests should be conducted with a sp ecies that also

have TGAI data available.34 of 80 Guideline Number Description Species TGAI/

TEP MRID/

Accession Classification Data Gap? Comments

Fathead

Minnow EP 00103297 Acceptable

Chinook

Salmon TGAI 46112001 Supplemental

Sheepshead

Minnow TGAI 00108837 Supplemental 850.1075

Estuarine/Marine

fish – Acute toxicity

Data needed for 1 species. Data needed for TEP if applied directly to water, maximum

EEC ≥ 0.5 LC 50 , or end

product enhances toxicity. Sheepshead

Minnow EP 00103316 Supplemental Yes Based on variability in the measured concentrations compared to nominal concentrations, the presence of precipitate and the test concentrations exceeding solubility, the true exposure

concentration is not known in submitted tests. Studies examining the toxicity of the TGAI and TEP

to E/M fish are needed.

Waterflea TGAI 00103297 Acceptable 1

Waterflea EP 00010329

7 Acceptable

Waterflea EP 00103296 Supplemental 850.1010

Freshwater

invertebrates – Acute toxicity 3

Crayfish TGAI 00162774 Supplemental No Data are needed on EPs that are representative of current TEPs. The registrant should provide information indicating whether studies examining toxicity to EPs are applicable to current TEPs or submit studies examining exposure

to EPs that are representative of

current TEPs.

Midge TGAI 00103297 Supplemental 1

Eastern oyster (shell deposition) TGAI 00103310 Supplemental

Eastern
oyster TGAI 00103311 Supplemental

Eastern oyster (shell deposition) EP 00103314 Supplemental

Eastern
oyster EP 00103315 Supplemental

Pink Shrimp TGAI 00112789 Acceptable 2

Pink Shrimp EP 00103312 Supplemental 2

Blue Crab TGAI 00108836 Supplemental Yes 850.1025, 850.1035, 850.1045, 850.1055

Estuarine/Marine

invertebrates – Acute toxicity 4

Blue Crab EP 00103313 Supplemental Data are needed on oyster shell deposition for the TGAI and TEP

because of variable results and due to variability in measured concentrations or the presence of precipitate in tests.35 of 80 Guideline Number Description Species TGAI/

TEP MRID/

Accession Classification Data Gap? Comments

Waterflea TGAI 00103297 Supplemental 1

Waterflea TGAI 00103297 Supplemental 1

Waterflea EP 00103297 Supplemental 1 850.1300

Freshwater

invertebrate – life cycle test

Data required for 1 species.

Midge EP 00103297 Supplemental 1 Yes A full lifecycle study for one freshwater invertebrate study is needed. The exposure

concentration of the submitted

studies is not known because the

concentration was not measured.

Measured concentrations in studies

conducted with these studies were

sometimes very different from

nominal concentrations

.

850.1350

E/M invertebrate – Life Cycle 5 No data submitted Pending May be needed if the acute LC 50 < 1 mg/L or the EEC is ≥ 0.01 of

acute LC 50 .

850.1400

Freshwater fish – early life stage test 6 Chinnok

Salmon TGAI 45915601 Acceptable No An ACR can be calculated using

the acute value for an EP for the

Fathead minnow and the full lifecycle study.

850.1400

E/M – early life stage test 7 No data submitted

Yes Data are needed because chronic exposure to E/M species may occur; however, these data will be

available from the fish full life cycle study.

850.1500

Freshwater Fish –

life cycle test 8 Fathead

Minnow TGAI 00103309 Acceptable No An ACR can be calculated using

the acute value for an EP for the

Fathead minnow and the full lifecycle study.

850.1500

E/M Fish – life cycle test 9 No data submitted Yes Data are needed because chronic exposure to E/M species may occur and a reduced egg production was observed at the highest test concentration in the freshwater fish full lifecycle test (MRID 00103309).

850.1735

Whole sediment

acute freshwater

invertebrate 10 No data submitted No The aerobic aquatic degradation half-life was greater than 10 days (MRID 44154801). No data are

needed.

850.1740

Whole sediment

acute marine

invertebrates 11 No data submitted No No data are needed because direct application to the E/M environment is prohibited on the

labels.36 of 80 Guideline Number Description Species TGAI/

TEP MRID/

Accession Classification Data Gap? Comments

Whole sediment

chronic

invertebrate

freshwater and

marine 12 No data submitted Yes Data are needed for freshwater

invertebrates because aerobic aquatic half-lives of fluridone (MRID 44154801) are greater than 10 days and some K OC values are ≥

1000 L/kg (BLM 2005). Most reported K OC values ranged from 270-6400 (BLM 2005).

Abbreviations: E/M = estuarine/marine; TEP=typical end use product; EP= end use product; TGAI=technical grade active ingredient;

1- The test was conducted by the U.S. Fi sh and Wildlife Service and a complete review has not been completed.

2- Concentrations in solution were measured af ter filtering and showed reasonable recovery.

3- Data needed for one species. Data needed for TEP if applied directly to water, maximum EEC ≥ 0.5 LC 50 , or end product enhances toxicity

4- Data required for one mollusk and invertebrate. Data needed for TEP if applied directly to water, maximum

EEC ≥ 0.5 LC 50 , or end product enhances toxicity.

5- Data are required for one species when the chemical is applied directly to the E/M environment, acute LC 50 < 1 mg/L, or the EEC is ≥ 0.01 of acute LC 50

. 6- Data on one species are needed on a species with acute data.

7- Data are required for one species when the chemical is applied directly to the E/M environment, acute LC 50 < 1 mg/L, or the EEC is ≥ 0.01 of acute LC 50

. 8- Data are required for one species when applied directly to water or if EEC is ≥ 0.1 of NOEL in fish early life stage, or if studies suggest reproduction physiology may be affected.

9- Data are required for one species when applied directly to water or if EEC is ≥ 0.1 of NOEL in fish early life stage or if studies suggest reproduction physiology may be affected.

10- Data are required when half-life of pesticide in sediment ≤ 10 days and 1) the Kd is ≥ 50 L/kg, 2) the K OC ≥ 1000 L/kg, or the K OW ≥ 1000.

11- Data are required for one species for uses with direct application to E/M water. Data are required when halflife of pesticide in sediment ≤ 10 days and 1) the Kd is ≥ 50 L/kg, 2) the K OC ≥ 1000 L/kg, or the K OW ≥ 1000 L/kg.

12- Data required if EEC> 0.1 of acute LC 50 and the half-life > 10 days and if any of the following exist: the log

K OW ≥ 3 or the K OC ≥ 1000 L/kg. Data required for E/M when applied directly to E/M environment.

Avian Acute Oral Toxicity (G uideline 850.2100): Passerine Speci es and Upland Game Bird or Waterfowl

Acceptable acute avian oral toxi city data were submitted for e xposures of bobwhite quail to fluridone; however, data are not available for passerines, wh ich are required under the new 40 CFR Part 158 data requirements for conventiona l pesticides (72 FR 60934; USEPA 2007b). The new Part 158 data requirements specify that acute avian oral toxicity data be submitted for either a mallard duck or bobwhite quail AND a passerine species. EFED suggests that the Special Review and Reregistration Divisi on (SRRD) request submission of a passerine study protocol for review by the Agency prior to in itiation of this study. If oral acute toxicity data are not submitted for passerines, EFED will assume acute risk for passerine species. The highest dose tested should be high enough to evaluate risk at the predicted exposure.

Additionally, estimated expos ure using TREX (version 1.4.1, 10/9/2008) and the highest application rate (4.9 lbs a.i./A) with one a pplication predicts a maximum exposure of 1339 mg/kg-body weight (bw). The ratio of the EEC/LD 50 of 2000 mg/kg-bw results in a ratio of37 of 80 0.93. As multiple applications may take place, pr edicted exposure may exceed the highest dose

tested for birds. Without data to predict effects at the predicte d exposure level, we may not be able to preclude risk for birds.

Avian Reproduction Studies (Guideline 850.2300): Upland Game Bird and Waterfowl

No acceptable avian reproduction studies are availa ble to evaluate the reproductive and chronic toxicity of fluridone to birds. Birds may be exposed to fluridone via drinking water and on residues on food items. Without toxicity data for fluridone available to preclude chronic risk to birds, it is assumed that risk to birds may occur.

Honeybee Acute Contact Toxicity (Guideline 850.3020) with TGAI

The honeybee acute contact toxicity test was completed using the TEP and a dust carrier. The use of the dust could result in lower exposure to the bee than for a liquid because the dust particles may not be in dermal contact if the dust is caught in hairs. Fluridone does have registered products with liquid form ulations and the available test could underestimate toxicity of a liquid formulation. Therefore, an acute contac t toxicity study using the TGAI is needed to

assess risk to bees. Without da ta to preclude risk to terrestri al invertebrates, risk will be presumed.

Terrestrial Plants (G uideline 850.4100 and 850.4150)

Toxicity data for terrestrial plants are not available. Ba sed on the 40 CFR Part 158 data requirements, Tier II level non-target terrestrial plant data are required fo r all herbicides. In addition, the label indicates that irrigation of terrestrial plants with water containing fluridone could injure the irrigated vegetation at 10 ppb or 5 ppb (EPA Regist ration Number 61842-11). Therefore, this data gap must be filled, and non-ta rget terrestrial plant da ta are required. In the absence of Tier II data, EFED will assume risk to terrestrial monocots and dicots.

Acute Toxicity to Freshwater Fish (Guide line 850.1075): Coldwater and Warmwater species using the TEP; Estuarine/marine Acute Toxicity to Fish (Guideline 850.1075) using the TGAI and TEP; and Freshwater Invertebrate Acute Toxicity (Guideline 850.1010) with the TEP; and

Estuarine/marine Invertebrate Acute Toxici ty (Guideline 850.1025) examining Oyster Shell Deposition with TGAI and TEP

Quantitative data examining acute toxicity to fr eshwater fish and freshwater invertebrates exposed to an EP are available; however, it is not known if the studes were conducted on products that are representative of products currently registered. EFED recommends the registrant provide information on whether the availa ble data are applicable to current products or conduct studies with EPs that are representative of current TEPs. Quantitative estuarine/marine fish, and estuarine/marine invertebrates shell de position are not available for the TGAI or TEP. Quantitative acute toxicity to estuarine/marine invertebrate shell deposition is not available for the TEP. Based on the 40 CFR Part 158 data requirements, these data are required for all pesticides applied directly to water. In addi tion, available qualitative data and incident data38 of 80 indicate that direct effects are likely with use of fluridone as recommended on labels. Therefore, these data gaps must be filled. In the absence of data, EFED will assume risk to both freshwater

and estuarine/marine fish and invertebrates.

Estuarine/marine Fish Full Life Cycle (Guideline 850.1500) with TGAI

40 CFR Part 158 requires an estuarine/marine fi sh full lifecycle study for one species when the pesticide is applied directly to water or if EEC is ≥ 0.1 of NOEL in fish early life stage or if studies suggest reproduction physiology may be aff ected. Data are needed because fluridone will be applied directly to water, chronic exposur e to estuarine/marine species may occur, and a reduced egg production was observed at the highest test concentrati on in the freshwater fish full lifecycle test (MRID 00103309). Given that fecundity endpoints are highly variable, the lab that

conducts the test should ensure that an appropriate number of re plicates be used. Usually for nonparametric tests, four replicates are required.

Freshwater Fish Full Lifecycle (Guideline 850.1500) for One Species with Acute Data

Chronic toxicity data are available for the fath ead minnow. Quantitative acute data with the

TGAI are not available for the fathead minnow 6 . Based on the 40 CFR Part 158 data requirements, these data are require d for all pesticides applied directly to water. These data are needed to evaluate risk to more sensitive sp ecies using an acute-to-ch ronic ratio (ACR). An acute endpoint for the fathead minnow is availabl e for an EP. Based on the data available for Rainbow trout and Channel catfish, the toxicity endpoints of the EP and TGAI are similar (MRID 00103297). Therefore, an ACR may be cal culated for Fathead minnow using the EP endpoint of 8.3 mg a.i./L. EFED does not re commend requesting additional data for this requirement at this time.

Whole Sediment Chronic Freshwater Invertebrate

No chronic toxicity data for freshwater invert ebrates are available. 40 CFR 158 requires whole sediment chronic toxicity data for freshwate r invertebrates if th e EEC > 0.1 of acute LC 50 and the half-life > 10 days and if any of the following exist: the log K OW ≥ 3 or the K OC ≥ 1000 L/kg.

Data are needed for freshwater invertebrates because:

• the maximum applied concentration per gr owing season of 0.150 mg/L is > 0.1 of the preliminary supplemental acute 48-hr EC 50 of 1.3 mg/L for the midge (MRID 00103297);

• aerobic aquatic half- lives of fluridone (MRID 44154801) are greater than 10 days;

• and some K OC values are ≥ 1000 L/kg (BLM 2005). 7

6 The acute toxicity test submitted for the fathead minnow resulted in an LC 50 value that is greater than the solubility (MRID 00103297). As exposure is not likely to occur at a c oncentration much greater than the solubility in distilled water, the true exposure concentration resulting in mortality is not known.

7 Most reported K OC values ranged from 270-6400 L/kg (BLM 2005). Open literature values have not been formally reviewed. The values will be reviewed for possible use in the environmental fate characterization. In the interim, sediment toxicity data is requested. The need to evaluate potential sediment toxicity as an exposure pathway in the future risk assessment will be determined based on the review of the open literature K OC values.39 of 80 In the absence of data, toxicity will be estimate d using the lowest chronic toxicity endpoint for

freshwater invertebrates in freshwater and the estimated pore water concen trations in sediment.

Aquatic Plant Studies (850.4400 and 850.5400)

Toxicity data for vascular and non-vascular aqua tic plants were not submitted to the Agency. Based on the 40 CFR Part 158 data requirements, Ti er II level non-target aquatic plant data are required for all herbicides. In addition, available ope n literature data fo r non-target aquatic plants show impacts to many aquatic species at a concentration less than the maximum single application rate for fluridone (MacDonald et al. 2008; Doong et al. 1993) and it is used to control aquatic vegetation. Therefore, this data gap must be filled, and non-target aquatic plant data for algae and vascular plants are required. In the absence of Tier II data, EFED will assume

risk to both vascular and non- vascular aquatic plants.

Toxicity of NMF

The potential toxicity of NMF is a source of unc ertainty for the assessment. Although potential exposure of receptors to NMF is uncertain, NM F can form in the environment; however, the toxicity threshold for receptors is not known. During Registration Re view, toxicity data will be evaluated for compounds with a similar structure to NMF. NMF has been detected in some

submitted fate studies and concentrations increased throughout the study (MRID 00103326), therefore acute and chronic toxicity data on NMF to fish, aquatic invert ebrates, and birds are necessary for the Registration Review risk assess ment. If data are not submitted and exposure is likely to occur, the Agency will evaluate potenti al toxicity using data for chemicals with a similar structure. A preliminary estimate of exposure, assuming only one application indicates that exposure to NMF may occur at high e nough levels to elicit toxicity (Appendix C).

Toxicity of 3-trifluoromethyl benzoic acid

No aquatic toxicity data were available for 3-trifluoromethyl benzoic acid in the public ECOTOX database when searched on April 22, 2009 (USEPA 2009b). Data based on ECOSAR version 1.0 indicates that the toxicity endpoints for aquatic organisms would range from 9 - 2706 mg/L, using the neutral organic acid chemical class (Appendix D). Th is suggests that the toxicity of 3-trifluoromethyl benzoic acid is similar to th e toxicity of fluridone. 3- trifluoromethyl benzoic acid was detected in so me submitted fate studies and concentrations increased throughout the study, indi cating that exposure to 3-trif luoromethyl benzoic acid may occur (MRID 00103326). During Registration Review , toxicity data will be evaluated for compounds with a similar structure to 3-trifl uoromethyl benzoic acid. Based on the submitted ECOSAR data, the toxicity of this degradate will be assumed to be similar to the parent for aquatic organisms. Acute and chronic toxicity data on 3-trifluoromethyl benzoic acid to birds are necessary for the Registration Review risk assessment. If data are not submitted, the Agency will evaluate potential toxicity using data for chemicals with a similar structure.40 of 80 Testing on Typical e nd-use products (TEP)

A Typical End-Use Product is defined in the Pesticide Assessment Guidelines Subdivision J Hazard Evaluation: Nontarget plants on Part 120-2(1) on Page 18 as “a pesticide product that is representative of a majo r formulation category ( e.g ., emulsifiable concentrate, granular product, wettable powder) and pesticide group ( e.g ., herbicide, fungicide, insecticide etc .) and contains the active ingredient of the applicant’ s product.” (Holst and Ellwanger, 1982)

Page 5 of the Pesticide Assessment Guidelines Subdivi sion J Hazard Evaluation: Nontarget plants provides additional information on what TEP data should be tested for toxicity testing in the following excerpt.

“The Agency seeks to avoid imposing a burde n of duplicative testi ng on applicants for registration. Therefore, wher e 40 CFR Part 158 specifies that the test substance should be a representative end-use product, testing may be performed using the formulation in question (end-use product being registered) or similar, yet representative, end-use product. It is not necessary to repeat the test using other similar products.” (Holst and Ellwanger, 1982)

When TEP data are requested data should be submitted for the different formulations,

e.g ., wettable powder, emulsifiable concentrate, granular, along with a rationale as to why the TEP is representative of other similar end-use products.”

7.9. Other Information Needed for the Risk Assessment

Current labels do not have a maxi mum number of applications or minimum application interval. In order to estimate exposure, a maximum numb er of applications and minimum application

interval will be assumed based on a conservati ve estimate. Adding a maximum number of applications and a minimum application interval to labels would significantly reduce uncertainty in exposure estimates. Additionally, informa tion on typical number of applications and application intervals would be useful.

In order to assess the risk to te rrestrial organisms exposed to flur idone pellets the weight of one pellet for each pelleted formulation is needed.

8. References

8.1. Open Literature

BLM (Bureau of Land Management). 2005. Fluridone Ecological Risk Assessment. Final Report. BLM Contract Number NAD010156. ENSR Document Number 09090-020- 650. Reno, Nevada.

CFR 40. 2007. Code of Federal Regulati ons 40 Parts 150 to 189. Protection of the Environment. U.S. Government Printing Office.41 of 80 Doong, R.L.; G.E. Macdonald; and D.G. Shilling. 1993. Effect of fluridone on chlorophyll, carotenoid, and anthocyanin content of Hydrilla. J. Aquat. Plant Manage 31: 55-59.

E.I. du Pont de Nemours and Company, LP. 2005. Overall summary for N-methyl formamide. Robust Summaries and Test Plans. November 5, 2005. http://www.epa.gov/HPV/pubs/summaries/monomthf/c15159rt2.pdf (accessed April 13, 2009). Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the EPA food-chain (Kenaga) nomogram, an instru ment for estimating pesticide residues on plants. Environ. Tox. Chem . 13:1383-1391.

Fox, A.M.; W.T. Haller; D.G. Shilling. 1996. Hydril la control with split treatments of fluridone in Lake Harris, Florida. Hydrobiologia 340: 235-239.

HSDB (Hazardous Substances Data Bank). 2002. N-Methylformamide. Complete update on

04/19/2002. Available at: http://toxnet.nlm.nih.gov/ cgi-bin/sis/search (accessed 05/03/2009).

HSDB. 2005. Benzoic acid. Upda ted 11/14/2005. Available at: http://toxnet.nlm.nih.gov/cgibin/sis/search (accessed 05/21/2009).

Herbicide Resistance Action Committee (HRAC). 2005. Classification of Herbicides According to Mode of Action. January 2005. Available at: http://www.hracglobal.com/Publications/Cla ssificationofHerbicideModeofAction/tabid/2 22/Default.aspx (accessed April 17, 2009).

Hoerger, F. and E. E. Kenaga, 1972. Pesticide Re sidues on Plants: Correlation of Representative

Data as a Basis for Estimation of th eir Magnitude in the Environment. In F. Coulston and F. Korte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology, Georg Thieme Publ., Stuttg art, West Germany, pp. 9-28.

Holst, R. W., & Ellwanger, T. C. 1982. Pesticide Assessment Guidelines. Subdivision J. Hazard Evaluation: Nontarget Plants . EPA-540/09-82-020. October 1982. Office of Pesticide Programs. Office of Pesticides and Toxic Substances. United States Environmental Protection Agency.

MacDonald, G. E.; A. Puri; and D.G. Shilling. 2008. Interactive effect of photoperiod and fluridone on growth, reproduction, and bi ochemistry of Dioecious Hydrilla ( Hydrilla

verticiliata ). Weed Science 56: 189-195.

Paul, E. A., Simonin, H. A., Symu la, J., & Bauer, R. W. 1994. The toxicity of diquat, endothall, and fluridone to the early life stages of fish. J. Freshwater, Ecol., 9 (3), 229-239.

Popova, L. 1996. Effect of fluridone on plan t development, leaf anatomy and plastid ultrastructure of barley plants. Bulg. J. Plant Physiology 22(1-2): 3-12.42 of 80 Schmitz, D.C. 1986. The Aquatic Herbicide Sonar (Fluridone ): A Review of the Scientific

Literature. TSS-86-100. June 1986. Florida Department of Natural Resources. Bureau of Aquatic Plant Research and C ontrol. Tallahassee, FL.

USEPA (U.S. Environmental Protection Agency). 1991. Ecological Effects Branch Review.

Sonar as herbicide. Case Number 031626. Office of Pe sticide Programs. Washington,

D.C.

USEPA. 1993. Wildlife Exposure Factors Ha ndbook. EPA/600/R-13/187a, Office of Research and Development, Washington, D.C.

USEPA. 1998. Guidelines for Ecological Risk A ssessment. Risk Assessment Forum, Office of Research and Development, Washi ngton, D.C. EPA/630/R-95/002F. April 1998. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759

USEPA. 2002. Guidance for Selecting Input Parame ters in Modeling the E nvironmental Fate and Transport of Pesticides, Version II. US Environmental Protection Agency, Washington

DC. Online at: http://www.epa.gov/oppefed1/mode ls water/input_guidance2_28_02.htm

.

USEPA. 2003. Fluridone Use Closure Memo (P C Code 112900). Memo From R. McNally, to M. Stasikowski. Special Review Branch, Office of Pesticide Programs. Washington,

D.C.

USEPA. 2004a. Fluridone and its major degradate, N- methyl formamide - Drinking Water Assessment for the Health Effects Division (HED) Reregistration Eligibility Decision

Document. PC Code 112900. DP Barcode D300012. April 1, 2004. Environmental

Fate and Effects Division. Office of Pesticide Programs. Washington, D.C.

USEPA. 2004b. Human Health Risk Assessment for Fl uridone TRED. PC Code 112900. DP

Barcode D306456. August 17, 2004. Registration Branc h, Office of Pesticide Programs. Washington, D.C.

USEPA 2004c. Fluridone: Toxicology Chapter for RED and Updating Executive Summaries for 11 studies. DP Barcode D291522 . August 30, 2004. Health Effects Division, Office of Pesticide Programs. Washington, D.C.

USEPA. 2004d. Overview of the Ecological Risk Assessmen t Process in the Office of Pesticide Programs . U.S. Environmental Protection Agenc y, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington DC. January 23, 2004.

USEPA. 2007a. Ecological Incident Information System. http://www.epa.gov/espp/consultation/ecorisk-overview.pdf

USEPA. 2007b. 40 CFR Part 158. Pesticides; Da ta Requirements for Conventional Chemicals: Final Rule. 72 FR 60934. October 26, 2007.43 of 80 USEPA 2007c. Product Chemistry Review on Fluridone Technical . August 6, 2007. D338136. Registration Division. Of fice of Pesticide Programs. Washington, DC.

USEPA. 2008a. Environmental Fate, Ecological Risk and Endangered Species Assessment in Support of the Registration Review of Fomesafen Sodium (PC123802) . December 2008.

Environmental Fate and Effects Division. O ffice of Pesticide Programs. Washington,

DC.

USEPA. 2008b. Environmental Fate and Ecological Risk Assessment for Etofenprox New Uses on Rice and for Vector Control . June 30, 2008. Environmental Fate and Effects

Division. Office of Pesticid e Programs. Washington, DC.

USEPA. 2009a. Usage/Use Report Package in S upport of Registration Review for Fluridone. January 29, 2009. Biological a nd Economic Analysis Divisio n. Office of Pesticide Programs. Washington, DC.

USEPA 2009b. ECOTOXicology Database. Offi ce of Research and Development National

Health and Environmental Effects Research Laboratory’s (NHEERL’s) Mid-Continent Ecology Division (MED). http://cfpub.epa.gov/ecotox/

U.S. Fish and Wildlife Service (USFWS) and Na tional Marine Fisheries Service (NMFS). 1998. Endangered Species Consultation Handbook: Procedures for Conducting Consultation and Conference Activities Under Section 7 of the Endangered Species Act. Final Draft

. March 1998.

U.S. FWS/NMFS. 2004. Letter providing an eval uation by the U.S. Fish and Wildlife Service

and National Marine Fisheries Service of an approach to assessing th e ecological risks of pesticide products. From Steve Williams and William Hogarth to Susan Hazen. January 26, 2004.

Ware, G. W.; D. M. Whitacre. 2004. An Introduction to Herbicides. In The Pesticide Book, 6 th

ed; Radcliffe, E. B, Hutchison, W. D. Eds.; MeisterPro Information Resources: Willoughby, OH, 2004. Available at http://ipmworld.umn.edu/chapters/whitacreherb.htm (accessed March 26, 2008).

Wood, A. 2009. Compendium of Pesticide Co mmon Names. Last updated on January 8, 2009.

Online at: http://www.alanwood.net/pesticides/index.html

8.2. Submitted Fate Studies

MRID Citation Reference44 of 80 MRID Citation Reference 28724 Berard, D.F.; Rainey, D.P.; Shuey, E. W. (1980) Dissipation of 14C Fluridone from Water of Artificial Ponds. (Unpub lished study received Feb 7, 1980 under 1471-EX-67; submitted by Elanco Prod- ucts Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL: 099227-A)

28725 West, S.D. (1980) An Interim Report of Fluridone Residues in Water and Fish. (Unpublished study received Feb 7, 1980 under 1471- EX-67; submitted by Elanco Products Co., Div. of Eli Lill y and Co., Indianapolis, Ind.; CDL:099227- B) 30255 Berard, D.F.; Rainey, D.P. (1980) Dissi pation of 14C Fluridone from Water of Artificial Ponds. (Unpublished study r eceived Apr 3, 1980 under 1471-EX-67; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:099338-A) 30256 Rainey, D.P. (1978) Uptake and Metabo lism of 14C Fluridone by Blue- gills. (Unpublished study received Apr 3, 1980 under 1471-EX- 67; submitted by Elanco Products Co., Div. of Eli Lill y and Co., Indianapolis, Ind.; CDL:099338- C) 30257 West, S.D.; Day, E.W., Jr.; Burger, R.O. (1979) Dissipation of the experimental aquatic herbicide Fluridone from lakes and ponds. Journal of Agricultural and Food Chemistry 27(5):1067-1072. (Also~In~unpublished submission received Apr 3, 1980 under 1471- EX-67; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:099338-D) 30257 West, S.D.; Day, E.W., Jr.; Burger, R.O. (1979) Dissipation of the experimental aquatic herbicide Fluridone from lakes and ponds. Journal of Agricultural and Food Chemistry 27(5):1067-1072. (Also~In~unpublished submission received Apr 3, 1980 under 1471- EX-67; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:099338-D) 51379 Eli Lilly and Company (1979) EL-171 (F luridone) Aquatic Weed Management. (Reports by various sources; rece ived May 21, 1980 under 1471-EX-67; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:242489-A) 103318 Meyerhoff, R.; Parka, S.; Brannon, D.; et al. (1982) Some Physical, Chemical, and Biological Characteristics of a Lake and Ponds Treated with Sonar AS and Sonar 5P Aqueous and Pellet Formula- tions of Fluridone (EL-171, Compound 112371). (Unpublished study received Jun 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli L illy and Co., Indianapolis, IN; CDL: 070935-G) 103320 Berard, D.; Rainey, D.; Shuey, E. ( 1980) Dissipation of 14C Fluridone from Water of Artificial Ponds. (Unpublis hed study received Jun 10, 1982 under 1471-126; submitted by Elanco Prod- ucts Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL: 070936-B)
103321 Rainey, D.; Shuey, E. (1978) Uptake and Metabolism of 14C Fluridone by Bluegills. (Unpublished study received Jun 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070936-C)45 of 80 MRID Citation Reference 103326 Mosier, J.; Saunders, D.; Sieck, R.; et al. (1982) Photolysis of Fluridone in Aqueous Solution: S-AAC-79-10. (Unpublished study received Jun 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL: 070937-B) 103327 Rainey, D.; Shuey, E. (1982) Anaerobic Aquatic Metabolism of 14C Fluridone. (Unpublished study received Jun 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070937-C) 103333 West, S.; Burger, R.; Poole, G.; et al. (1982) Field Dissi pation and Residue Trials with the Aquatic Herbicide S onar in Lakes and Ponds. (Unpublished study received Jun 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indi anapolis, IN; CDL:070937-I) 103334 West, S.; Burger, R.; Hamelink, J. (1980) Determination of Residues of Fluridone and its Major Me tabolite in Fathead Minnows during a Full Life Cycle Study. (Unpublished study received J un 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lill y and Co., Indianapolis, IN; CDL:070937-J) 121695 Rainey, D.; Shuey, E. (1978) Uptake and Metabolism of 14C Fluridone by Bluegills. (Unpublished study rece ived Dec 14, 1978 under 1471-EX-66; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-N) 121696 Arnold, W. (1978) Fluridone--a New A quatic Herbicide. (Unpublished study received Dec 14, 1978 under 1471-EX-66; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-O) 121697 McCowen, M.; Young, C.; West, S.; et al. (1978) Fluridone , a New Herbicide for Aquatic Plant Management. (Unpub lished study received Dec 14, 1978 under 1471-EX-66; prepared by Aquatic Plant Management Society, Inc., submitted by Elanco Products Co., Div of Eli Lill y and Co., Indianapolis, IN; CDL:236621-P)
125742 West, S.; Burger, R.; Schmalz, C.; et al. (1983) Residues in Crops and Soils Irrigated with Water Containing the A quatic Herbicide Fluridone: S-AAC-81-20. (Unpublished study received Feb 17, 1983 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:071406-B) 125743 Mosier, J.; Saunders, D.; Sieck, R.; et al. (1982) Photolysis of Fluridone in Aqueous Solution: S-AAC-79-10. (Unpublished study received Feb 17, 1983 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:071406-C) 135213 Day, E.; West, S. (1975) EL-171 for W eed Control in Cotton Soil Residues. (Unpublished study received Aug 21, 1978 under 1471- EX-64; submitted by Elanco Products Co., Div. of Eli L illy and Co., Indianapolis, IN; CDL:097341- H) 135214 West, S.; Amundson, M. (1978) Fluridone Residues in Soil. (Unpub- lished study received Aug 21, 1978 under 1471-EX- 64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-I) 135215 West, S.; Burger, R.; Cleary, D.; et al . (1978) Fluridone and Trifluralin Residues in Soil. (Unpublished study rece ived Aug 21, 1978 under 1471-EX-64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-J)46 of 80 MRID Citation Reference 135216 Rainey, D.; Magnussen, J. (1977) 14C Fluridone Soil Degradation Studies. (Unpublished study received Aug 21, 1978 under 1471- EX-64; submitted by Elanco Products Co., Div. of Eli L illy and Co., Indianapolis, IN; CDL:097341- K) 135217 Berard, D.; Amundson, M. (1978) 14C Fl uridone Degradation Study in Aerobicand Anaerobic Soil. (Unpublished study received Aug 21, 1978 under 1471-EX64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-L) 135218 Loh, A.; Buchanan, G.; Amundson, M. (1978) Soil Adsorption Coeffi- cient of Fluridone. (Unpublished study rece ived Aug 21, 1978 under 1471-EX-64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-M) 135219 Decker, O.; Amundson, M. (1978) Fluridone Soil Leaching Study. (Unpublished study received Aug 21, 1978 under 1471-EX- 64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., I ndianapolis, IN; CDL:097341-N) 135220 Decker, O. (1975) Hydrolysis Study of Compound EL-171. (Unpub- lished study received Aug 21, 1978 under 1471-EX-64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-O) 135221 Day, E.; Sherman, W. (1975) Photoche mical Rate Studies with EL-171 in Aqueous Solution. (Unpublished study received Aug 21, 1978 under 1471-EX64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-P) 135369 Elanco Products Co. (1978) EL-171 as fo r Aquatic Plant Manage- ment Systems: Fish and Wildlife ?and Microscopic Or ganisms|. (Unpublished study received Dec 14, 1978 under 1471-EX-67; CDL:097725-C) 135371 Elanco Products Co. (1978) EL-171 as fo r Aquatic Plant Manage- ment Systems: Environmental Chemistry. (Unpublis hed study received Dec 14, 1978 under 1471-EX-67; CDL:097725-L) 135372 Rainey, D. (1978) Uptake and Metabo lism of 14C Fluridone by Blue- gills. (Unpublished study received Dec 14, 1978 under 1471- EX-67; prepared by Lilly Research Laboratories, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097725-N)
159966 West, S. (1982) Determination of Fl uridone in Soil and Hydrosoil by High Pressure Liquid Chromatography: AM-AA-CA-R017-AC-755. Un- published study prepared by Lilly Research Laboratories. 10 p.

162339 West, S.; Weston, J. (1985) Fluridone Concentration in Water from Drainage Canals Receiving Split Applicati ons of Sonar 5P: Study No. EWD8501. Unpublished study prepared by Lilly Re search Lab- oratories. 27 p. 162340 West, S. (1984) Projected Residues of Fluridone in Water, Hydro-soil, and Edible Fish Tissue upon Retreatment of Lakes with Sonar: Study No. EWD8426. Unpublished study prepared by Lilly Research Laboratories. 11 p. 162341 West, S. (1986) Data To Support a Seven- day Retreatment Interval for Sonar in Lakes, Reservoirs, Canals, and Ri vers: Study No. EWD8621. Unpublished study prepared by Lilly Research Labora- tories. 6 p.47 of 80 MRID Citation Reference 162775 West, S.; Weston, J. (1985) Residues of Fluridone and Its Major Metabolites in Crayfish from Ponds Treated with th e Aquatic Herbicide Sonar: EWD8436. Unpublished study prepared by Lilly Research Laboratories. 76 p. 162775 West, S.; Weston, J. (1985) Residues of Fluridone and Its Major Metabolites in Crayfish from Ponds Treated with th e Aquatic Herbicide Sonar: EWD8436. Unpublished study prepared by Lilly Research Laboratories. 76 p.40485901 West, S.; Turner, L. (1987) Determination of Fluridone in Water by Highperformance Liquid Chromatography Fo llowing Extraction with Sep-Pak C18 Cartridges. Unpublished validation study prepared by Lilly Research Laboratories. 13 p. 40485902 West, S.; Turner, L. (1987) Gas Chro matographic Determination of Residue Levels of N-methylformamide in Wate r. Unpublished Validation study prepared by Lilly Research Laboratories. 16 p.

41424101 Decker, O. (1988) Hydrolysis Study of Fluridone: Lab Project I.D.: ODD8803. Unpublished study prepared by Lilly Research Laboratories. 8 p. 44138501 Heim, L. (1996) Adsorption-Desorption of (carbon 14)-Fluridone in Soil and Sediment: (Final Report): Lab Project Number: 43187: T3E/ /ESADSB/US/** **/162. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 103 p.

44154801 Serak, K. (1996) Aerobic Aquatic Meta bolism of (carbon 14 )-Fluridone: Lab Project Number: 43186: T3E/ /EW METB/US/** **/3. Unpublished study prepared by Analytical Bio-Chemistry Labs, Inc. 91 p.

46866401 Heilman, M.; Koschnick, T.; Tarver, D.; et. al. (2006) Depuration of Fluridone Residues From Dry-Treated Sediments Following Seasonal Flooding of Irrigation Canals in Id aho. Unpublished study prepared by SePRO Corp. 16 p. 47139001 West, S. (1986) Data To Support a Seven- Day Retreatment Interval for Sonar in Lakes, Reservoirs, Canals, and Ri vers. Project Number: EWD8621, YAQUAT. Unpublished study prepared by Lill y Research Laboratories. 6 p. 47139002 West, S. (1982) Determination of Flur idone in Water by Hi gh Pressure Liquid Chromatography with U.V. Detection. Project Number: AM/AA/CA/R011/AC/755. Unpublished study prepared by Lilly Research Laboratories. 4 p. 47139007 West, S. (1984) Projected Residues of Flur idone in Water, Hydrosoil, and Edible Fish Tissue Upon Retreatment of Lakes with Sonar. Project Number: EWD8426. Unpublished study prepared by Lilly Research Laboratories. 11 p.

8.3. Submitted Effects Studies

MRID Citation Reference

00121686 Kehr, C.; West, H.; Hamelink, J.; et al. (1978) The Toxicity of Compound 112371 (EL-171) to Bobwhite Quail in a 14- day Acute Oral Study: Study No. 7005-78. (Unpublished study received Dec 14, 1978 under 1471-EX-66; submitted by48 of 80 MRID Citation Reference

Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-E)

00121687 Kehr, C.; Hamelink, J.; Probst, G.; et al. (1978) The Toxici ty of Compound 112371 (EL-171) to Bobwhite Quail in an Eight-day Dietary Study: Study No. 7008-78. (Unpublished study received Dec 14, 1978 under 1417-EX-66; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-F)

00121688 Kehr, C.; Hamelink, J.; Probst, G.; et al. (1978) The Toxici ty of Compound 112371 (EL-171) to Mallard Ducks in an Eigh t-day Die- tary Study: Study No. 7009-78. (Unpublished study received Dec 14, 1978 under 1471-EX-66; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-G)

00135211 Kehr, C.; Hamelink, J.; Probst, G.; et al. (1978) The Toxici ty of Compound 112371 (EL-171) to Mallard Ducks in an Ei ght-day Dietary Study: Study No. 7009-78. (Unpublished study received Aug 21, 1978 under 1471-EX-64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-C)

00135370 Kehr, C.; Hamelink, J.; Probst, G.; et al. (1978) The Toxici ty of Compound 112371 (EL-171) to Mallard Ducks in an Ei ght-day Dietary Study: Study No. 7009-78. (Unpublished study received Dec 14, 1978 under 1471-EX-67; prepared by Lilly Research Laboratories, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097725-G)

00103293 Ringer, R.; Breslin, W.; Flaga, C.; et al . (1981) The Toxicity of Fluridone (EL-171, Compound 112371) in a One-generation Re- production Study with Bobwhite: Study A018-79. (Unpublished study received Jun 10, 1982 under 1471-126; prepared in coopera- tion with Michigan State Univ., submitted by Elanco Products Co., Div. of Eli Lilly and Co., I ndianapolis, IN; CDL:070932-B)

00103294 Ringer, R.; Breslin, W.; Flaga, C.; et al . (1981) The Toxicity of Fluridone (EL-171, Compound 112371) in a One-generation Re- production Study with Mallards: Study A019-79. (Unpublished Study received Jun 10, 1982 under 1471-126 prepared in coopera- tion with Michigan State Univ., submitted by Elanco Products Co., Div. of Eli Lilly and Co., I ndianapolis, IN; CDL:070932-C)

00103297 Probst, G.; Hamelink, J.; Mayerhoff, R.; et al. (1982) The Toxicity of Fluridone (El-171, Compound 112371) and of Sonar AS, an Aqueous Suspension Formulation of Fluridone, to Aquatic In- ve rtebrates and Fish in Acute and Chronic Studies. (Unpublished study received Jun 10, 1982 under 1471-126; prepared in cooperation with U.S. Fish and Wildlife Service, Columbia National Fisheries Research Laboratory

, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070932-F)

00103306 Negilski, D.; Probst, G. (1981) The Toxi city of Sonar AS, an Aqueous Suspension Formulation of Fluridone (EL-171, Co mpound 112371), to Bluegi lls in a 96-hour Static Test: Study F053-80. (Unpublis hed study received Jun 10, 1982 under 1471- 126; sub- mitted by Elanco Products Co., Di v. of Eli Lilly and Co., In- dianapolis, IN; CDL:070934-A)49 of 80 MRID Citation Reference

00103307 Negilski, D.; Probst, G. (1981) The Toxi city of Sonar AS, an Aqueous Suspension

Formulation of Fluridone (EL-171, Compound 112371), to Ra inbow Trout in a 96- hour Static Test: Study F056- 80. (Unpub lished study received Jun 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070934-B)

00103308 Negilski, D.; Probst, G. (1981) The Toxicity of Flur idone (EL-171, Compound 112371) to Bluegills in a 96-hour Sta tic Test: Study 2023-79. (Unpublished study received Jun 10, 1982 under 1471- 126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indiana polis, IN; CDL:070934-C)

00121689 Karnak, R.; Kehr, C.; Hamelink, J.; et al. (1978) The Toxi city of Compound 112371 (EL-171) to Bluegills in a 96 Hour Static Test: Study No. 2075-78. (Unpublished study received Dec 14, 1978 under 1471-EX-66; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-H)

00121690 Kehr, C.; Karnak, R.; Hamelink, J.; et al. (1978) The Toxi city of Compound 112371 (EL-171) to Rainbow Trout in a 96 Hour Static Test: Study No. 2019-78. (Unpublished study received Dec 14, 1978 under 1471-EX-66; submitted by Elanco Products Co., Div. of Eli Lill y and Co., Indianapolis, IN; CDL:236621-I)

00135212 Karnak, R.; Kehr, C.; Hamelink, J.; et al. (1978) The Toxi city of Compound 112371 (EL-171) to Bluegills in a 96 Hour Static Test: Study No. 2075-78. (Unpublished study received Aug 21, 1978 under 1471-EX-64; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:097341-D)

00103296 Negilski, D.; Probst, G. (1981) The Toxi city of Sonar AS, an Aqueous Suspension Formulation of Fluridone (EL-171, Co mpound 112371) to Daphnia magna in a 48- hour Static Test: Study C001- 80. (Unpub lished study received Jun 10, 1982 under 1471-126, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070932-E)

00103297 Probst, G.; Hamelink, J.; Mayerhoff, R.; et al. (1982) The Toxicity of Fluridone (El-171, Compound 112371) and of Sonar AS, an Aqueous Suspension Formulation of Fluridone, to Aquatic In- ve rtebrates and Fish in Acute and Chronic Studies. (Unpublished study received Jun 10, 1982 under 1471-126; prepared in cooperation with U.S. Fish and Wildlife Service, Columbia National Fisheries Research Laboratory, submitted by Elanco Pr oducts Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070932-F)

00121691 Kehr, C.; Karnak, R.; Hamelink, J.; et al. (1978) The Toxi city of Compound 112371 (EL-171) to Daphnia magna in a 48-hour Static Test: Study No. 5004-78. (Unpublished study received Dec 14, 1978 under 1471-EX-66; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-J)

00162774 Meyerhoff, R. (1984) The Toxicity of Fluridone (EL-171, Compound 112371) to Crayfish (Orconectes immunis) in a 14-day Flow- through Test: Study C03083. Unpublished study prepared by Lilly Research Laboratories. 32 p.50 of 80 MRID Citation Reference

00103310 Heitmuller, T. (1981) Acute Toxicity of Compound 112371 to Eastern Oysters (Crassostrea virginica): Report No. BP -80-8-136; Lilly Study No. S001-80. (Unpublished study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070934-G)

00103311 Hollister, T. (1981) Acute Toxicity of Compound 112371, to Embryos- larvae of Eastern Oysters (Crassostr ea virginica): Report No. BP-80-7-125; Lilly Study No. S005-80. (Unpublished study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070934-H)

00103312 Heitmuller, T. (1981) Acute Toxicity of Sonar AS, a Formulation of Lilly Compound 112371 to Pink Shrimp (Penaeus duorarum): Report No. BP-80-8-137; Lilly Study No. C005-80. (Unpublished study received Jun 10, 1982 under 1471- 126; prepared by EG & G Bio- nomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indiana polis, IN; CDL:070935-A)

00103313 Heitmuller, T. (1981) Acute Toxicity of Sonar AS, a Formulation of Lilly Compound 112371 to Blue Crabs (Callinectes sapidus): Report No. BP-80-10-172; Lilly Study No. C008-80. (Unpublished study received Jun 10, 1982 under 1471- 126; prepared by EG & G Bionomics, s ubmitted by Elanco Products Co., Div. of Eli Lilly and Co., Indiana polis, IN; CDL:070935-B)

00103314 Heitmuller, T. (1981) Acute Toxicity of Sonar AS, a Formulation of Lilly Compound 112371 to Eastern Oysters (Crassos trea virgin- ica): Report No. BP-80- 10-193; Lilly Study No. S002-80. (Unpub- lished study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., I ndianapolis, IN; CDL:070935-C)

00103315 Hollister, T. (1981) Acute Toxicity of Sonar AS, a Formulation of Lilly Compound 112371 to Embryos-larvae of Eastern Oyster s (Crassostrea virginica): Report No. BP-80-7-126; Lilly Study No. S006- 80. (Unpublished study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., I ndianapolis, IN; CDL: 070935-D)

00103316 Heitmuller, T. (1981) Acute Toxicity of Sonar AS, a Formulation of Lilly Compound 112371 to Sheepshead Minnows (Cypr inodon vari- egatus): Report No. BP-80-7-130; Lilly Study No. F13480. (Un- published study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., I ndianapolis, IN; CDL:070935-E)

00108836 Heitmuller, T. (1981) Acute Toxici ty of Compound 112371 to Blue Crabs (Callinectes sapidus): Report No. BP-80-10-168; Lilly Study No. C007-80. (Unpublished study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070934-F)51 of 80 MRID Citation Reference

00108837 Heitmuller, T. (1981) Acute Toxici ty of Compound 112371 to Sheeps- head Minnows (Cyprinodon variegatus): Report No. BP-80-7-131; Lilly Study No. F13180. (Unpublished study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070934-I)

00112789 Heitmuller, T. (1981) Acute Toxici ty of Compound 112371 to Pink Shrimp (Penaeus duorarum): Report No. BP -80-8-135; Lilly Study No. C004-80. (Unpublished study received Jun 10, 1982 under 1471-126; prepared by EG & G Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL: 070934-E)

46112001 Rhodes, J. (2003 ) Seawater Challenge Test to Meas ure Seawater Adaptability of

Juvenile Chinook Salmon Oncorhynchus tshawytscha , Exposed to Fluridone. Project Number: 48163. Unpublished study prep ared by Analytical Bio-Chemistry Labs, Inc. 47 p.

45915601 Madsen, T. (2003) Early Life Stage Toxi city of Fluridone to the Chinook Salmon, Oncorhynchus tshawytscha , Under Flow-Through Conditions: Lab Project

Number: 47895: AM-AA-CA-R031-AC-755. Unpublished study prepared by ABC Laboratories, Inc. 106 p. {OPPTS 850.1400}

00103309 Hamelink, J.; Sauter, S.; Probst, G.; et al. (1981) The Toxi city of Compound 112371 (EL-171, Fluridone) to Fathead Minnow, in a Full Life Cycle Study: Study 2019-79. (Unpublished study received Jun 10, 1982 under 1471-126, prepared in cooperation with E.G. and G. Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indian apolis, IN; CDL:070934-D)

00103317 Meyerhoff, R.; Probst, G.; Hamelink, J.; et al . (1982) Performance of Fish Populations in Ponds Treated with So nar 4AS, an Aqueous Formulation of Fluridone (EL-171, Compound 112371): Study F14880. Interim rept., year one. (Unpublished study received Jun 10, 1982 under 1471-126; prepared in cooperation with Aquatic C ontrol, Inc., submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indiana polis, IN; CDL:070935-F)

00103334 West, S.; Burger, R.; Hamelink, J. (1980) Determination of Residues of Fluridone and its Major Metabolite in Fathead Minnows during a Full Life Cycle Study. (Unpublished study received Jun 10, 1982 under 1471-126; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:070937-J)

00103295 Atkins, E. (1982) Letter sent to R. Willemsen dated Mar 17, 1982: Laboratory honey bee toxicity tests on fluridone . (Unpublished study received Jun 10, 1982 under 1471-126; prepared by Univ. of Califor nia--Riverside, Dept. of Entomology, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL: 070932-D)

00121685 Lembi, C.; Leva, S. (1977) Effects of Fl uridone on Benthic Inverte- brates: Report #1. (Unpublished study received Dec 14, 1978 under 1471-EX-66; prepared by52 of 80 MRID Citation Reference

Purdue Univ., Dept. of Botany and Plant Pathology., submitted by Elanco Products Co., Div. of Eli Lilly and Co., I ndianapolis, IN; CDL:236621-D)

00121692 Karnak, R.; Kehr, C.; Hamelink, J.; et al. (1978) The Toxi city of Compound 112371 (EL-171) to Earthworms in a 14-day Soil Incorporated Study: Study No. 6002-78. (Unpublished study received

00121698 Hiltibran, R. (1978) Letter sent to G. Shoop dated Jun 1, 1978 ?Effects of EL 171 on Pond Life|: Report #2. (Unpublis hed study received Dec 14, 1978 under 1471- EX-66; prepared by Illi- nois Natural History Survey, Aquatic Biology Section, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:236621-Q)53 of 80 

### Appendix A: Data Call In Tables

Fluridone: Acute Oral T oxicity to Passerine Species

Guideline Number: 850.2100 Study Title: Avian Oral Toxicity (Passerine Species with TGAI) Rationale for Requiring the Data No data for passerine species are available. Although the submitted avian acute data suggest that fluridone is practically nontoxi c to the bobwhite quail, toxicity data for game birds may not reflect risks to passerine birds which have been identified to be more sensitive to pesticides in some cases than the Bobwhite Quail or Mallard Du ck. Therefore, additional data are needed to accurately assess risks to these species. Specifi cally, data are required on one passerine species in addition to either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and re sidential outdoor uses.

Practical Utility of the Data

How will the data be used? The passerine acute toxicity data are needed for future regulatory decisions, and for endangered species assessments. The data will allow the Agency to better assess the risks to these organisms, including the likelihood of potential risks to endangered species, either by direct effects or by indirect effects such as reducing food sources to listed pred ators and scavengers. Results of this study would be used to calculate acute ri sks to passerine species from exposure to fluridone and to identify whether current labeling is appropriate and whether further mitigation is

necessary.

How could the data impact the Agency’s future decision-making?

If the data indicate that fluridone poses a significant acu te risk to upland game or passerine birds, the Agency may explore additional decision options to minimize the risk of fluridone to these species. If future endangered species risk a ssessments are performed without these data, the Agency would have to assume that fluridone "m ay affect" passerine birds directly and other endangered species indirectly through loss of pr ey. The lack of these data will limit the flexibility the Agency and registrants have in complying with the Endangered Species Act and could result in unnecessary use restri ctions, and the use of fluridone may need to be restricted in areas where endangered species occu r unless these data are provided.

Fluridone: Chronic Toxicity for Avian Species

Guideline Number: 850.2300 Study Title: Avian Reproduction Study (Upland Game Bird and Waterfowl with TGAI) Rationale for Requiring the Data No data on reproductive toxicity to birds is avai lable. A chronic risk assessment for birds is needed based on fluridone's use patterns and pot ential impact on birds. The avian reproduction toxicity study is justified for fluridone because 1) the avian reproduction studies for waterfowl and upland game bird species are standard data requirements for all ou tdoor terrestrial and aquatic use patterns, 2) eviden ce of chronic toxicity to mamm als indicates possible chronic toxicity in birds, and 3) fluridone's use patter n indicates that chronic exposure is likely. Practical Utility of the Data54 of 80 How did the Agency make its re-registration decision without this data? An ecological risk assessment was not conducted for the re-registration decision for fluridone.

How will the data be used? The avian reproduction studies are needed for futu re regulatory decisions and for an endangered species assessment in particular. The data woul d allow the Agency to quantify the potential for chronic risk, as measured by effects on reproduc tion and hatchling survival, from the use of fluridone. Results of this study would be used to calculate risks to avian reproduction from dietary exposure to fluridone at labeled use rates and to identify what, if any, label language is needed to mitigate identified risks.

How could the data impact the Agency’s future decision-making? If future endangered species risk assessments are performed without th ese data, the Agency would have to assume that fluridone "may aff ect" birds directly (and endangered species from other taxa indirectly), an d use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flex ibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in

use restrictions for fluridone which are unnecessarily severe.

Fluridone: Honeybee Acute Contact Toxicity

Guideline Number: 850.3020 Study Title: Honeybee Acute Contact Toxicity with TGAI Rationale for Requiring the Data The honeybee acute contact toxicity test subm itted was completed using the TEP using a dust

carrier. The use of the dust could result in lowe r exposure to the bee if the dust is caught in hairs. Fluridone does have regi stered products with liquid formul ations and the available test could underestimate toxicity of a liquid formulation. Additionally, 40 CFR 158 requires the Honeybee Acute Contact Toxicity study to be co mpleted using the TGAI. Therefore, an acute contact toxicity study is needed to assess risk to bees. Without data to preclude risk to terrestrial invertebrates, risk will be presumed. Practical Utility of the Data How did the Agency make its re-registration decision without this data? An ecological risk assessment was not conducted for the re-registration decision for fluridone.

How will the data be used? The honeybee acute contact toxicity data are needed for future regulatory decisions, and for endangered species assessments. The data will a llow the Agency to better assess the risks to these organisms, including the likelihood of pot ential risks to endange red species, either by direct effects or by indirect effects such as reducing food sources to listed predators and scavengers. Results of this study would be used to calculate risks to insects and endangered species from exposure to fluridone and to identif y whether current labeli ng is appropriate and whether further mitigation is necessary.

How could the data impact the Agency’s future decision-making?

If the data indicate that fluridone poses a significant ri sk to terrestrial inve rtebrates, the Agency may explore additional decision options to minimize the risk of fluridone to these species. If55 of 80 future endangered species risk assessments are performed without these data, the Agency would have to assume that fluridone "may affect" terr estrial invertebrates dir ectly and other endangered species indirectly through loss of prey. The l ack of these data will li mit the flexibility the Agency and registrants have in complying with the Endangered Species Act and could result in unnecessary use restrictions, and th e use of fluridone may need to be restricted in areas where endangered species occur unle ss these data are provided.

Fluridone: Acute and Chroni c Toxicity to Freshwater Fish

Guideline Number: 850.1075 Study Title: Acute Toxicity Freshwater Fi sh (Coldwater and Warmwater Fish with TEP) Rationale for Requiring the Data It is likely that aquatic organisms may be acutely exposed to th e entire formulation because it is applied directly to water. 40 CFR 158 requires data for both the TGAI and TEP for products applied directly to water. It is not known if acute data available on end pr oducts are applicable to current products of fluridone on the market. Information on whether the available data on end-products are applicable to current products or new toxicity testing (OPPTS Guideline 850.1075) on using EPs that are representative of cu rrent TEPs are needed to assess risk from exposure to the formulation.

The requested data would allow EPA to estimate acute risks to freshw ater fish, including defining an action area for endangered sp ecies. Risk mitigation strategies ( e.g ., determining the maximum fluridone application rate that results in an RQ belo w the LOC) cannot be evaluated

without these data. Practical Utility of the Data How did the Agency make a re-registration decision without these data? An ecological risk assessment was not complete d with the reregistrati on decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of th at decision. These data would allow the Agency

to determine acute and chronic risk to freshwater fish from exposure to fluridone formulations.

The effects data would be used to determine th e likelihood that the acute risks can potentially impact aquatic communities, either by direct e ffects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Agency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) belo w the Level of Concern (L OC)) cannot be evaluated

without these data. If future endangered species risk assessmen ts are performed without these data, the Agency would have to assume that fl uridone “may affect” endangered freshwater fish directly (and endangered species fr om other taxa indirec tly), and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrant s have in coming into compliance with the Endangered Species Act and could result in use re strictions for fluridone which are unnecessarily

severe.56 of 80 Fluridone: Acute Estuarin e/Marine Organism Toxicity

Guideline Number: 850.1025 Study Title: Acute Toxicity Estuarine/Mari ne Mollusk Toxicity Study (Shell Deposition, TGAI and TEP)

Guideline Number: 850.1075 Study Title: Estuarine/Marine Fish Acute Toxicity Study (TGAI and TEP) Rationale for Requiring the Data 40 CFR Part 158 requires acute toxicity data on one estuarine/marine mollusk and one estuarine/marine fish species. When a pesticid e enters the aquatic environment estuarine/marine organisms may be exposed. When the pesticide is added directly to the aquatic environment a study examining the toxicity of the formulation is also required. Acute toxicity data for the Sheepshead minnow have been submitted; however the exposure concentrati on in the studies is not known and more data are needed for use quan titatively in th e assessment. Data are also available on oyster shell deposition; however, data are still needed on oyster shell deposition for

the TGAI and TEP because of variable results and due to variability in measured concentrations or the presence of precipitate in submitted tests.

There is insufficient data available to assess the potential mortality risk of fluridone to marine/estuarine organisms. Fl uridone is added directly to fr eshwater aquatic environments which may flow into estuarine/marine waters. Additionally, fluridone concentrations in treated water must be maintained for prolonged periods in order for fluridone to be effective for some species. Therefore, exposure to fluridone is likely.

The requested data would allow EPA to estimate acute risks to estuarine/marine mollusks and fish, including defining an action area for endangered species. Risk mitigation strategies ( e.g ., determining the maximum fluridone application ra te that results in an RQ below the LOC)

cannot be evaluated without these data. Practical Utility of the Data How did the Agency make a re-registration decision without these data? An ecological risk assessment was not complete d with the reregistrati on decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of that decision. The data would allow the Agency

to determine acute risk to estuarine/marine or ganisms from water expos ure to fluridone. The

effects data would be used to determine the lik elihood that the acute risk s can potentially impact aquatic communities, either by direct effects or by indirect effects on other organisms by reducing their food sources. Additionally, endpoints may be used to estimate chronic toxicity to estuarine/marine organisms using an acute-to-ch ronic ratio from data on freshwater species.

How could the data impact the Agency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) belo w the Level of Concern (L OC)) cannot be evaluated

without these data. If future endangered species risk assessmen ts are performed without these57 of 80 data, the Agency would have to assume that fluridone “may affect” endangered saltwater mollusks and fish directly (and endangered specie s from other taxa indi rectly), and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and c ould result in use restrictions for fluridone which are unnecessarily severe.

Fluridone: Acute and Chronic Toxicity and Sediment Toxicity to Freshwater

Invertebrates

Guideline Number: 850.1010 Study Title: Freshwater Invertebrate Acute Toxicity (TEP)

Guideline Number: 850.1300 Study Title: Daphnid chronic life-cycle

Guideline Number: Not Available Study Title: Whole Sediment Chronic Freshwater Invertebrate Rationale for Requiring the Data Fluridone is applied directly to the aquatic environment and conc entrations are maintained for several weeks. It is likely that aquatic or ganisms may be acutely exposed to the entire formulation because it is applied directly to wa ter. 40 CFR 158 requires data for both the TGAI and TEP for products applied directly to water. It is not known if acute data available on end products are applicable to current products of fluridone on the market. Information on whether the available data on end-products are applicable to current products or new toxicity testing (OPPTS Guideline 850.1010) on EPs that are repr esentative of current TEPs are needed to assess risk from exposure to the formulation.

No data that can be used quantitatively were av ailable to the Agency fo r chronic toxicity to

freshwater invertebrates. Data on OPPTS Guid eline 850.1300 will be used to evaluate chronic

risk of freshwater inverteb rates exposed to fluridone.

No chronic whole sediment toxici ty data for freshwater inverteb rates are available. 40 CFR 158 requires whole sediment chronic t oxicity data for freshwater i nvertebrates if the EEC > 0.1 of

acute LC 50 and the half-life > 10 days and if a ny of the following exist: the log K OW ≥ 3 or the

K OC ≥ 1000 L/kg. Data are needed for fr eshwater invertebrates because:

• the maximum applied concentration per gr owing season of 0.150 mg/L is > 0.1 of the preliminary supplemental acute 48-hr EC 50 of 1.3 mg/L for the midge (MRID 00103297);

• aerobic aquatic half- lives of fluridone (MRID 44154801) are greater than 10 days;

• and some K OC values are ≥ 1000 L/kg (BLM 2005). 8

In the absence of data, toxicity will be estimate d using the lowest chronic toxicity endpoint for

freshwater invertebrates in freshwater and the es timated porewater concentr ations in sediment. This does not consider possible exposure via ingestion and coul d underestimate risk for some

8 Most reported K OC values ranged from 270-6400 L/kg (BLM 2005).58 of 80 invertebrates where ingestion is an important exposure pathway.

The requested data would allow EPA to estima te acute and chronic risks to freshwater invertebrates, including defining an action area for endangered species. Risk mitigation strategies ( e.g ., determining the maximum fluridone applica tion rate that results in an RQ below the LOC) cannot be evalua ted without these data. Practical Utility of the Data How did the Agency make a re-registration decision without these data? An ecological risk assessment was not complete d with the reregistrati on decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of that decision. The data would allow the Agency

to determine acute and chronic risk to freshwat er invertebrates from fluridone in water and

sediment. The effects data would be used to determine the likelihood th at the acute risks can potentially impact aquatic communities, either by direct effects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Ag ency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) below the Level of Concern (LOC)) cannot be

evaluated without these data. If future enda ngered species risk assessments are performed without these data, the Agency would have to assume that fluridone “may affect” endangered freshwater invertebrates directly (and endangered species from othe r taxa indirectly), and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and c ould result in use restrictions for fluridone which are unnecessarily severe.

Fluridone: Toxicity to Terrestrial Plants

Guideline Number: 850.4100 Study Title: Seedling emergence (Tier II)

Guideline Number: 850.4150 Study Title: Vegetative vigor (Tier II) Rationale for Requiring the Data The only data on the toxicity of fluridone to terre strial plants is found in the ECOTOX database (a collection of reports from the open literature). Because the fluridone studies in this database differ significantly from OPP standa rds or are in other ways not re liable, they are not sufficient for a quantitative assessment of risk s to terrestrial plants. Terrestrial plants may be exposed to fluridone with spray drift or when water treated with fluridone is used with irrigation. As fluridone is an herbicide it is expe cted to result in toxicity to plan ts. Possible risks to terrestrial plants cannot be evalua ted without these data. Practical Utility of the Data How did the Agency make its re-registration decision without these data? An ecological risk assessment was not complete d with the reregistrati on decision for fluridone.59 of 80 How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of that decision. The data would allow the Agency

to determine acute and chronic risk to fres hwater invertebrates fr om water exposure to
fluridone. The effects data would be used to de termine the likelihood that terrestrial plants may be injured with use of fluridone, either by di rect effects or by indi rect effects on other organisms.

How could the data impact the Ag ency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) below the Level of Concern (LOC)) cannot be

evaluated without these data. If future enda ngered species risk assessments are performed without these data, the Agency would have to assume that fluridone “may affect” endangered terrestrial plants directly (and endangered species from other taxa indirectly), and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and c ould result in use restrictions for fluridone which are unnecessarily severe.

Fluridone: Toxicity to Aquatic Plants

Guideline Number: 850.4400 Study Title: Aquatic plant toxicity (Tier II)

Guideline Number: 850.5400 Study Title: Algal Toxicity (Tier II) Rationale for Requiring the Data The only data on the toxicity of fluridone to a quatic plants is found in the ECOTOX database (a collection of reports from the open literature). Because the fluridone studies in this database differ significantly from OPP standa rds or are in other ways not re liable, they are not sufficient for a quantitative assessment of risks to aquatic plants. Aquatic plants may be exposed to fluridone as it is applied directly to water. As fluridone is an herbic ide it is expected to result in toxicity to plants. Possible risks to aquatic plants cannot be evaluate d without these data. Practical Utility of the Data How did the Agency make its re-registration decision without these data? An ecological risk assessment was not completed with the re-registration decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of th at decision. Effects da ta would be used to determine the likelihood that aqua tic plants may be injured with use of fluridone. The data would allow the Agency to evaluate potential risk to aquatic plants and indirect risk to other

taxa due to reduction in food and/or habitat.

How could the data impact the Ag ency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application60 of 80 rate that results in Risk Quotients (RQs) below the Level of Concern (LOC)) cannot be

evaluated without these data. If future enda ngered species risk assessments are performed without these data, the Agency would have to assume that fluridone “may affect” endangered plants (and endangered species from other taxa in directly), and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrant s have in coming into compliance with the Endangered Species Act and could result in use restrictions for fluridone which are unnecessarily severe.

Fluridone: Chronic Toxicity to Estuarine/marine Fish

Guideline Number: 850.1500 Study Title: Estuarine/marine Fish Full Lifecycle with TGAI Rationale for Requiring the Data 40 CFR Part 158 requires an estuarine/marine fi sh full lifecycle study for one species when the pesticide is applied directly to water or if EEC is ≥ 0.1 of NOEL in fish early life stage or if studies suggest reproduction physiology may be aff ected. Data are needed because fluridone will be applied directly to water, chronic exposur e to estuarine/marine species may occur, and a reduced egg production was observed at the highest test concentrati on in the freshwater fish full lifecycle test (MRID 00103309). Given that fecundity endpoints are highly variable, the lab that

conducts the test should ensure that an appropriate number of re plicates be used. Usually for nonparametric tests, four replicat es are required. A fish early lif e cycle test was not requested

because these data will be availabl e from the full lifecycle test.

The requested data would allow EPA to estimate chronic risks to estuarine/marine vertebrates, including defining an action ar ea for endangered species. Practical Utility of the Data How did the Agency make a re-registration decision without these data? An ecological risk assessment was not complete d with the reregistrati on decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of that decision. The data would allow the Agency

to determine chronic risk to estuarine/marine fis h. The effects data would be used to determine

the likelihood that the chronic ri sks can potentially impact aquatic communities, either by direct effects or by indirect eff ects on other organisms by reduc ing their food sources.

How could the data impact the Agency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) belo w the Level of Concern (L OC)) cannot be evaluated

without these data. If future endangered species risk assessmen ts are performed without these data, the Agency would have to assume that fl uridone “may affect” endangered estuarine/marine fish directly, and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Enda ngered Species Act and could result in use

restrictions for fluridone wh ich are unnecessarily severe.61 of 80 Degradate: N-Methyl Formamide (NMF) Guideline 850.2100: avian acute oral toxicity Guideline 850.2300: avian reproduction study Guideline 850.1075: acute toxicity to freshwater fish for one coldwater and one warmwater species

Guideline 850.1010: freshwater in vertebrate acute toxicity Guideline 850.1400: freshwater fish early life stage and estuarine/marine early life stage

Guideline 850.1300: freshwater invertebrate life cycle

Rationale for Requiring the Data

There is insufficient data available to assess th e potential mortality risk of the degradate Nmethyl formamide to aquatic and terrestrial or ganisms. N-methyl formamide was identified by

the Health Effects Division in th e Human Health Risk assessment used to support the tolerance re-registration decision (TRED) for fluridone. It was found at a maximum of 74% of applied fluridone equivalents in a study examining photolysis in distilled water and a maximum of 36% applied fluridone equivalents in a study exam ining photolysis in lake water (MRID 00103326). Concentrations of NMF in photolysis studies incr eased over time, indicating that NMF could be stable to hydrolysis and photolysis (MRID 00103326) . As fluridone may be applied with slowrelease pellets or with repeated applications, exposure to NMF is likely. The limited data on NMF submitted to the Agency showed developm ental toxicity in mammals (see the human

health risk assessment used to s upport the TRED). This indicates that chronic toxi city may occur with exposure to NMF.

If data are not submitted, toxicity data for chemi cals with a similar struct ure to NMF will be used to predict potential toxicity of NMF to aquatic and terr estrial organisms.

The requested data would allow EPA to estimate risk to aquatic and te rrestrial organisms to exposure to N-methyl formamide, including de fining an action area for endangered species. Risk mitigation strategies ( e.g ., determining the maximum fluridone application rate that results in an RQ below the LOC) cannot be evaluated without these data. Practical Utility of the Data How did the Agency make its re-registration decision without these data? An ecological risk assessment was not completed with the re-registration decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of that decision. The data would allow the Agency to determine risk to aquatic and terrestrial orga nisms exposed to NMF as a result of the use of

fluridone. The effects data would be used to determine the likelihood th at the acute risks can potentially impact aquatic and terrestrial commun ities, either by direct effects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Agency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) belo w the Level of Concern (L OC)) cannot be evaluated

without these data. If future endangered species risk assessmen ts are performed without these62 of 80 data, the Agency would have to assume that fluridone “may affect” endangered aquatic and terrestrial organisms directly (a nd endangered species from other taxa indirectly), and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and c ould result in use restrictions for fluridone which are unnecessarily severe.

Degradate: 3-trifluoromethyl benzoic acid Guideline 850.2100: avian acute oral toxicity Guideline 850.2300: avian reproduction study

Rationale for Requiring the Data

There is insufficient data available to assess th e potential mortality risk of the degradate 3- trilfluormethyl benzoic acid to terrestrial organisms. It was found at a maximum of 24% of applied fluridone equivalents in a study examin ing photolysis in distil led water and a maximum of 33% applied fluridone equivalents in a st udy examining photolysis in lake water (MRID 00103326). As fluridone may be applied with slow-re lease pellets or with repeated applications, exposure to 3-trifluoromethyl benzoic acid is likely.

If data are not submitted, toxicity data for chemicals with a similar structure to 3-trifluoromethyl benzoic acid will be used to predict potential toxi city of 3-trifluoromethyl benzoic acid to aquatic and terrestrial organisms.

The requested data would allow EPA to estimate risk to aquatic and te rrestrial organisms to exposure to 3-trifluoromethyl benzoic acid, including defining an action area for endangered species. Risk mitigation strategies ( e.g ., determining the maximum fl uridone application rate that results in an RQ below the LOC) ca nnot be evaluated without these data. Practical Utility of the Data How did the Agency make its re-registration decision without these data? An ecological risk assessment was not completed with the re-registration decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of that decision. The data would allow the Agency to determine risk to aquatic and terrestrial orga nisms exposed to 3-trifluoromethyl benzoic acid

as a result of the use of fluridone. The effect s data would be used to determine the likelihood that the acute risks can potentially impact aquatic and terrestrial communities, either by direct effects or by indirect eff ects on other organisms by reduc ing their food sources.

How could the data impact the Agency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) belo w the Level of Concern (L OC)) cannot be evaluated

without these data. If future endangered species risk assessmen ts are performed without these data, the Agency would have to assume that fluridone “may affect” endangered aquatic and terrestrial organisms directly (a nd endangered species from other taxa indirectly), and use of63 of 80 fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and c ould result in use restrictions for fluridone which are unnecessarily severe.

Fluridone and Degradat e N-methylformamide ECM and ILV Request Rationale for Requiring the Data Independent lab verification is being requested for MRID 162775. In order to support registration actions and registra tion review, relevant ECMs and a ssociated ILV reports regarding

fluridone and metabolites of concern should be submitted, reviewed, and found acceptable for the residues of concern. Acceptable ECMs for the residues of concern should have levels of quantitation that are adequate to address risk concerns or that are at levels below the toxicological endpoints for the relevant aquatic or terrestrial organisms.

The requested data would allow EPA to estimate ri sk to aquatic and terres trial organisms and to aid in validating dissipation studies. Practical Utility of the Data How did the Agency make its re-registration decision without these data? An ecological risk assessment was not completed with the re-registration decision for fluridone.

How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of that decision. The data would allow the Agency to determine risk to aquatic and terrestrial orga nisms exposed to NMF as a result of the use of

fluridone. The effects data would be used to determine the likelihood th at the acute risks can potentially impact aquatic and terrestrial commun ities, either by direct effects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Agency’s future decision-making? Risk assessment and mitigation strategies ( e.g. , determining the maximum fluridone application rate that results in Risk Quotients (RQs) belo w the Level of Concern (L OC)) cannot be evaluated

without these data. If future endangered species risk assessmen ts are performed without these data, the Agency would have to assume that fluridone “may affect” endangered aquatic and terrestrial organisms directly (a nd endangered species from other taxa indirectly), and use of fluridone might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and c ould result in use restrictions for fluridone which are unnecessarily severe.64 of 80Appendix B: Summary of Toxicity DataTable B1. Summary of Submitted Aquatic Toxicity Data for Fluridone.The Solubility of fluridone is 12.3 mg/L and the KOC~ranged from 240-6400 mg/kg (BLM 2005).*StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentsFreshwater VertebratesAcute850.1075Bluegill Sunfish(Lepomismacrochirus)/StaticTGAI99.496-hr LC50= 12.1 mg/L(measured)LOAEL = 10.6 mg/LNOAEL = 9.45 mg/LMortality00103308(1981)SupplementalDERAddendum09/01/2009)Water was not centrifuged or filtered beforemeasuring concentrations and TOC was notreported. Test concentrations exceeded solubility.Acetone solvent was present at maximumconcentrations of 500 ppm. Exposureconcentrations cannot be determined. Sublethaleffects included hyperactivity and irregularswimming. No sublethal effects were observed at2 mg/L and below. Mortality increasedsignificantly with a slight increase of dosage levelaround the solubility point. Measuredconcentrations ranged from 80-130% of nominaland mortality occurred at 12.5 mg/L and above.Acute850.1075Bluegill Sunfish(Lepomismacrochirus)/StaticEP44.596-hr LC50> 7.4 mg/LNOAEL < 5.9 mg/L(measured)No NOEL for sublethaleffectsNo mortality,sublethal effects atall treatment levels00103306(1982)SupplementalDER 7/14/82Water was filtered before measuringconcentrations. Total organic carbon (TOC) wasnot reported. The highest test concentrationsexceeded solubility. Measured values were 53-79% of measured values. Exposure concentrationscannot be determined. No mortality in 4 of 5 testconcentrations. Assayed concentrations or treatedgroups ranged from 5.4-6.6 mg/L. Fluridoneconcentrations decreased over time. Sublethaldose related effects were observed includinghyperactivity, irregular swimming behavior, lossof equilibrium, immobilization, and prostration.65 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentsAcute850.1075Bluegill Sunfish(Lepomismacrochirus)/StaticTGAINR00121689(1978)InvalidAcute850.1075Bluegill Sunfish(Lepomismacrochirus)/StaticTGAI 96-hr LC50 = 11 mga.i./L (total)(95% C.I. = 9.0 – 14(total))Nominal, MovingAverage MethodMortality 00103297Supplemental-qualitativeDER02/24/2010Mortality occurred at and above solubility. Whilefluridone concentration average was reported as>79% nominal, exposure concentrations at andabove solubility are unlikely to have solubleconcentrations near nominal (as evidenced byvalues that were reported for obs 13, 14, 24).Without actual reported analytical results, theresults are qualified here as a total basis. Sampleswere filtered prior to analysis. It is possible thatan effects endpoint could be obtained withtreatment levels between 10 and 12.3 mg a.i./L.Acute850.1075Bluegill Sunfish(Lepomismacrochirus)/StaticEP 96-hr LC50 = 6.5 (95%C.I.= 5.5-7.7;Litchfield-Wilcoxon)(measured)Mortality 00103297AcceptableDER02/24/2010Samples were filtered before measuringconcentration. TEP tested concentrations wereless than 79%. Measuredconcentrations were notprovided but the 96-hr LC50based on measuredconcentrations was reported in Appendix F of thestudy report.Acute850.1075Rainbow Trout(Salmo gairneri)/StaticTGAI 96-hr LC50 = 11.7±1.2mg/L (nominal)NOAEL = 5 mg/LNo NOEL for sublethaleffectsMortality 00121690(1978)SupplementalDERAddendum09/01/2009The highest nominal test concentration exceededsolubility (14 mg/L). Acetone with 0.1% Tween80 was used due to the low solubility. Up to7.5mL of solvent was added to test water (15L).The exposure concentration cannot be determinedbecause test concentrations were not measured.Sublethal effects were observed at all test levels.Hyperactivity occurred at all 2.75 and 3.65 mg/Lwithin 24 hours. Prostration was observed athigher test concentrations.Acute850.1075Rainbow Trout(Salmogairdneri)/ StaticEP44.596-hr LC50= 8.1 mg/L(measured)No NOEL for sublethalMortality, sublethaleffects at alltreatment levels.00103307(1981)SupplementalDER 7/14/82Water was filtered prior to measuringconcentration. All nominal test concentrationsexceeded solubility (18-31.5 mg/L). Fish in alltest vessels displayed irregular swimming patterns66 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentseffects or were prostrate on the bottom of the test vessels.Surviving fish, 96-hr later, were still severelystressed. Poor goodness of fit.Acute850.1075Rainbow Trout(Salmo gairneri)/StaticTGAI 6 studies96-hr LC50=5.1 mg/L (95% C.I.=4.1-6.4; binomial)(measured)5.7 mg/L (95% C.I.=4.5-7.4, probit)Slope = 6.7 (3.0-10.3)(nominal)5.6 (95% C.I.=3.2-10.0;binomial)(nominal)7.0 mg/L (95% C.I. =5.6-10.0; binomial)(nominal)6.7 mg/L (95% C.I. =5.3-8.5; probit)(nominal)8.0 mg/L (95%C.I.=5.6-10.0,binomial)(nominal)Immobility and loss ofequilibrium occurred at3.2 mg/L. Surfacingoccurred at 5.6 mg/L.Mortality 00103297AcceptableDER02/24/2010Analytical results for filtered water indicate thatactual fluridone concentrations average≥79% ofnominal concentrations. No trend with differingpH or hardness observed.67 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentsAcute850.1075Rainbow Trout(Salmo gairneri)/StaticTGAI 3 studies96-hr LC50ranged from4.5-8.0 mg/L, binomial,nominalMortality 00103297Supplemental-qualitativeDER02/24/2010Analytical results for filtered water indicate thatactual fluridone concentrations average <79% ofnominal concentrations or samples were stored toolong. No trend with differing pH or hardnessobserved.Acute850.1075Rainbow Trout(Salmo gairneri)/StaticEP 96-hr LC50=4.3 (95%C.I.= 2.9-6.3, binomial)(nominal)Mortality 00103297AcceptableDER02/24/2010Only 4 treatment levels. Measured concentrationsaveraged <79% nominal.Acute850.1075Channel Catfish(Ictaluruspunctatus)/StaticTGAI 96-hr LC50= 7.5 mg/L(95% C.I.=6.1-9.2;probit)Slope=10.2 (4.3-16.1)(nominal)Immobility occurred at5.6 mg/L. Loss ofequilibrium occurred at10 mg/L and surfacingat 7.5 mg/L.Mortality 00103297AcceptableDER02/24/2010Analytical results for filtered water indicate thatactual fluridone concentrations average≥79% ofnominal concentrations. Included only nominalconcentrations below the solubility limit.Acute850.1075Channel Catfish(Ictaluruspunctatus)/StaticTGAI 9 studies96-hr LC50= 8.7-13mg/L (nominal)Could not bedetermined in somestudies due to no or lowmortality at highesttreatment level belowsolutiliby.Mortality 00103297Supplemental-qualitativeDER02/24/2010Measured concentrations were < 79% nominal,samples were lost or not enough mortalityoccurred to determine an endpoint. Treatmentsabove solubility were included in estimated 96-hrLC50values as total concentrations. The reportedvalues likely overestimate the actual LC50value.Acute850.1075Channel Catfish(Ictaluruspunctatus)/StaticEP 96-hr LC50= 13 (total)(95% C.I.= 10 -18,binomial)NominalMortality 00103297Supplemental-qualitativeDER02/24/2010Water samples were lost thus no analyticalconfirmation of soluble exposure concentrationscan be made. No mortality occurred at anynominal treatment level below solubility.Exposure concentrations at near solubility are68 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentsunlikely to have soluble concentrations nearnominal (as evidenced by values that werereported for obs 13, 14, 24). Treatments abovesolubility were included in estimated 96-hr LC50values as total concentrations. The reported valueslikely overestimate the actual LC50valueAcute850.1075Fathead Minnow(Pimephalespromelas)/ StaticTGAI 96-hr LC50>10(nominal)Mortality 00103297Supplemental-qualitativeDER02/24/2010No mortality at any treatment level belowsolubility, all mortality occurred above solubility.While fluridone concentration average wasreported as >79% nominal, exposureconcentrations at and above solubility are unlikelyto have soluble concentrations near nominal (asevidenced by values thatwere reported for obs 13,14, 24). Without actual reported analytical results,the results are qualified here as a total basisAcute850.1075Fathead Minnow(Pimephalespromelas)/ StaticEP 96-hr LC50= 8.3 mg/L(measured, binomial)Mortality 00103297AcceptableDER02/24/2010Full LifeCycle850.1500Fathead Minnow(Pimephalespromelas)/ FlowThroughTGAI99.2LOAEL = 0.96 mg/LNOAEL = 0.48 mg/L(measured)Hatching success(80-85% versus 95-98%) and survivalof 30 day fry (0-5%versus 100%)00103309(1981)AcceptableDER 7/15/82Water samples were filtered prior to analysis.BCF = 3.23±1.65. Egg production was low inhighest test concentrations. Survival of F0 fryexposed to 0.96 mg/L was significantly reducedwhen compared to water control but not solventcontrol 30 days after hatching but not at 60 daysafter hatching. The number of eggs per spawn andthe number of eggs per female for the F0 variedsubstantially between replicate tanks for alltreatments and controls, except for the lowest(0.12 mg/L) treatment group. Some fish lost withtank overflowing.Chronic Channel Catfish(Ictaluruspunctatus)EP 60-day NOAEL = 0.5mg/L (nominal)Growth 00103297PreliminarysupplementalAnalytical results for filtered water indicate thatactual fluridone concentrations average≥79% ofnominal concentrations. Growth decreased at 1.0and 2.0 mg/L after 15 days exposure. Survival69 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentswas not statistically significant different fromcontrol but was much lower after 30 days exposure(68-70% versus 91%). The lower mortality wasattributed to a diluter malfunction on day 21 whichresulted 2.5 fold increase in exposureconcentration.Seawateradaptabilitytest andAcuteToxicity850.1075Chinook Salmon(Oncorhynchustshawytscha)/StaticTGAI99.496-hr LC50>5.76 mg/L96-hr LC22= 5.76 mg/L(measured)Mortality 46112001(2003)SupplementalDER02/24/2010Some fish jumped out of treatment tanks and nofish jumped out of control tanks. Sublethal effectsobserved in 1.53, 3.06, and 5.76 mg/L includingdark discolorations, loss of equilibrium, erraticswimming patter, fish resting at bottom of tank,surfacing, and jumping. Ability to adjust tosaltwater was also examined. Age of salmon notreported. Mean length was 130 mm for controlfish. Test fish were near 19 g in the acute toxicitytest and 22 g for the saltwater challenge test. Foracute toxicity test, fish should weigh less than 3 gand be juveniles. The 19 g salmon is considered ajuvenile.Early lifestage850.1400Chinook Salmon(Oncorhynchustshawytscha)/Flow ThroughTGAI99.4NOAEC = 0.430 mg/LNOAEC = 0.222 mg/L(measured)LengthGill histopathology(hypertrophy of gilllamellar epithelium)45915601(2003)SupplementalDER02/24/2010Study initiated with 34-day old embryos, 2-24hour old embryos are typicalor at the eyed stage.A 34 day salmon embryo is still in the eyed stage.Raw data on daily number hatched, daily survival,and daily swim up are needed to evaluatedevelopment rate.Estuarine/Marine VertebratesAcute850.1075SheepsheadMinnow(Cyprinodonvariegatus)/StaticTGAI98.196-hr LC50= 10.7 mg/L(measured)NOAEC = 3.1 mg/LMortality 00108837(1981)SupplementalDERAddendum09/01/2009Fish were exposed to concentrations exceedingsolubility (3.1, 5.8, 11.1, 24, and 48 mg/L,measured). Probit was not a good fit for data.Treatments were not replicated. Water wascollected at the beginning of the test and at the endof the test, combined, and the concentrationmeasured. The water was not centrifuged orfiltered prior to analysis.Acute Sheepshead EP 96-hr LC50= 18.1 mg/L Mortality 00103316 Based on the variability in the measured70 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceComments850.1075Minnow(Cyprinodonvariegatus)/Static43.16(measured) (1981)SupplementalDER 8/16/82concentrations compared to nominalconcentrations, the presence of precipitate and thetest concentrations exceeding solubility the trueexposure concentration is not known. Nominalconcentrations ranged from 3-50 mg/L. Mortalityobserved at 12 mg/L and above. Water wasfiltered prior to analysis. Measured concentrationsranged from 44-93% of nominal. 10% mortalityin controls. Data not corrected for controlmortality.Freshwater InvertebratesAcute850.1010Waterflea(Daphniamagna)/ StaticEP44.548-hr EC50= 3.6 mg/L(measured)NOAEL = 2.0 mg/LNo NOAEL forsublethal effects.Mortality 00103296(1981)SupplementalDER 7/13/82Water samples were filtered prior to analysis.Vessel did have aeration. Precipitation of testmaterial was observed. Measured concentrationsranged from 65-111% of nominal. No waterquality parameters measured. At 2 mg/L nomortality was observed and 65% mortality wasobserved at the next highest test concentration of 3mg/L. Data were not amenable to probit analysis.Sublethal effects observed at all testconcentrations include hyperactivity, prostration,and pale color.Acute Crayfish(Orconectesimmunis)/ FlowthroughTGAI99.714 day LC50> 16.9mg/L (measured)Mortality 00162774(1984)SupplementalDER 11/6/86Water samples were filtered prior to measuringwater concentrations. 2-3 deaths were observed atall treatment levels but the lowest treatment level.No mortality or behavioral signs of toxicity wereobserved for crayfish atthe 1.1 mg/L treatmentlevel. Sublethal effects were observed at thehighest treatment level.Acute850.1010Waterflea(Daphniamagna)TGAIandEP48-hr EC50= 5.2 mg/Lin 2 TGAI studies(nominal)48-hr EC50= 3.0 and4.0 mg/L in 2 EPMortality 00103297AcceptableDER02/24/2010Water samples were filtered (pore size and typenot specified) prior to measuring fluridoneconcentration in water. Measured concentrationswere≥79% of nominal. Actual measuredconcentrations were not reported in study.Technical and formulation toxicity was similar.71 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentsstudies(nominal)48-Hr EC50of studies conducted at 44 and 280mg/L hardness were the same.Acute Midge(Chironomousplumosus)TGAI 48-hr EC50= 1.3 mg/L(nominal, results from 2tests)Mortality00103297PreliminarySupplementalWater samples were filtered (pore size and typenot specified) prior to measuring fluridoneconcentration in water. Measured concentrationswere≥79% of nominal.AcuteAmphipod(Gammaruspseudolimnaeus)TGAI 96-hr LC50=2.1 -4.1mg/L (nominal; 2studies)Mortality00103297PreliminarySupplementalWater samples were filtered (pore size and typenot specified) prior to measuring fluridoneconcentration in water. Measured concentrationswere≥79% of nominal.Chronic850.1300Waterflea(Daphniamagna)TGAI 21 day NOAEL = 0.2mg/L (nominal)Mortality00103297PreliminarySupplementalSamples were stored too long and the sampleshipment was received in poor conditions. Waterconcentrations were not measured.Chronic Amphipod(Gammaruspseudolimnaeus)EP 60-day NOAEL = 0.6mg/L (nominal)Mortality00103297PreliminarySupplementalSamples were stored too long and the sampleshipment was received in poor conditions. Waterconcentrations were not measured.Chronic Midge(Chironomousplumosus)EP 30-day NOEL = 0.6mg/L (nominal)Mortality00103297PreliminarySupplementalSamples were stored too long and the sampleshipment was received in poor conditions. Waterconcentrations were not measured.Estuarine/Marine InvertebratesAcute850.1025Eastern Oyster(Crassostreavirginica)/ FlowThroughTGAI98.125% reduction in shellgrowth observed forsolvent control and at0.25 mg/L, a mid doselevel.Shell Growth 00103310(1981)SupplementalDER 7/27/82Water samples were filtered prior to measuringfluridone concentrations. Measured concentrationswere 70-102% of nominal. 10 oysters per vessel.Precipitation observed in test vessel. The currentguideline recommends 20 oysters per treatmentlevel and for controls. Shell deposition was lessthan 2 mm that is typical.Acute(EmbryoLarval)850.1055Eastern Oyster(Crassostreavirginica)/ StaticAge=embryoTGAI98.148-hr EC50= 16.8 mg/L(measured)NOAEC = 9.2 mg/LReduction in normallarvae00103311(1981)SupplementalDERAddendum09/02/2009Water samples were filtered prior to measuringfluridone concentrations. Measured values weremuch lower than nominal (9-105%) andconcentrations exceededsolubility. Measuredconcentrations ranged from 6.2-32.7 mg/L.Acute Eastern Oyster EP LOAEC = 0.08-0.62 Increased shell00103314 Water samples were filtered prior to analysis.72 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceComments(EmbryoLarval)850.1055(Crassostreavirginica)/ FlowThroughAge=embryo43.16 mg/L (measured)NOAEC notdetermined.deposition (1981)SupplementalDER 8/6/82Precipitate was present in test vessel. The initialmeasured concentration was 0.08 mg/L and thefinal measured concentration was 0.35 mg/L.New shell growth in all test treatments was equalto or greater than that ofthe seawater control. Themeasured concentration was not consistent and thetrue exposure concentration is uncertain.Acute(EmbryoLarval)850.1055Eastern Oyster(Crassostreavirginica)/ StaticAge=embryoEP43.1648-hr EC50= 6.8 mg/L(measured)Normal larvae 00103315(1981)SupplementalDER 8/6/82Water samples were filtered prior to analysis. Asignificant reduction in normal larvae of occurredin concentrations≥10 mg/L. An increase of about3 mg/L of the measured fluridone concentrationprovided a significant increase in abnormal larvae.Probit was not appropriate for data.Acute850.1045Pink Shrimp(Panaeusduorarum)/StaticAge = JuvenileTGAI98.1LC50= 4.6 mg/L(measured)Mortality 00112789(1981)AcceptableDER 7/23/82Water was filtered before measuringconcentrations of fluridone using HPLC; however,a sample was collected at the beginning of the testand at the end of the test, combined, filtered, andthen the concentration was measured. No testconcentrations exceeded solubility. 10 exposed pertreatment.Acute850.1045Pink Shrimp(Panaeusduorarum)/StaticAge = JuvenileEP43.1696-hr LC50= 2.4 mg/L(measured)NOAEC = 0.6 mg/LMortality 00103312(1981)SupplementalDER 8/4/82Water was filtered before measuringconcentrations of fluridone using HPLC; however,a sample was collected at the beginning of the testand at the end of the test, combined, filtered, andthen the concentration was measured. Measuredconcentrations were 60-100% of applied. Allconcentrations were below solubility. 5 shrimpper treatment. Aerated. The pore size of the filterpaper used to filter water was not reported. Thefilter paper was “Analytical Filter Paper,Schleicher and Schuell, 12.5 cm (No. 588). Notenough information is available to know the exactexposure concentrations.AcuteBlue Crab(CallinectesTGAI98.196-hr LC50= 27.04mg/L (measured)Mortality 00108836(1981)Water samples were filtered prior to measuring thefluridone concentrations. Precipitate was present73 of 80StudyTypeTest Species(GenusSpecies)/ Flowthrough/Static%a.i.Toxicity Endpoint(Measured/Nominal)EffectMRID(Year)Classificationor SourceCommentssapidus)/ StaticAge = JuvenileSupplementalDER 7/26/82at concentration > 12 mg/L. Measuredconcentrations were highly variable. LC50is basedon average concentrations measured at beginningand end of test.Acute Blue Crab(Callinectessapidus)/ StaticAge = JuvenileEP43.696 hr LC50= 34.0 mg/L(measured)Mortality 00103313(1982)SupplementalDER8/4/1982Water samples were filtered prior to measuring thefluridone concentrations. 10 crabs per treatment.Aerated. 50% morality observed at 34 mg/L and10% mortality at 77.5 mg/L. Both of theseconcentrations exceed solubility and TOC was notmeasured. The exposure concentration isuncertain.Other StudiesField Study BenthicCommunity00121685(1978)Not reviewedBenthic organisms were counted before and aftertreatment of ponds with fluridone.Abbreviations: TGAI = technical grade active ingredient; EP=end use product; conc.=concentration*Data submitted under MRID 103297 are data collected by the UnitedStates Fish and Wildlife Service.When toxicity data were available with measuredconcentrations≥79% of nominal the results from those tests were reported and the endpoints where the analyticalchemistry was missing were less than 79%were not reported. When data were only available without measured concentrations or with low recoveries, than the nominal value is reported.Table B2. Summary of terrestrial toxicity data submitted for fluridone.Study TypeTest SpeciesTGAI orEPToxicityEndpoint(95% C.I.)(Measured/Nominal)/SlopeEffectMRID (Year)Classification,DER date orsourceCommentsAcute Oral Rat TGAI LD50= 10,000mg/kgMortality USEPA 2004cSubchronic Oral(90 day oral)Mice TGAI NOAEL =15mg/kg/dayLOAEL=25mg/kg/dayHepaticcentrilobularhypertrophy00082342AcceptableUSEPA 2004c74 of 80Study TypeTest SpeciesTGAI orEPToxicityEndpoint(95% C.I.)(Measured/Nominal)/SlopeEffectMRID (Year)Classification,DER date orsourceCommentsSubchronic Oral(90 day oral)Rat TGAI NOAEL =25mg/kg/dayLOAEL=44mg/kg/dayIncreased absoluteand relative liverweights andrelative kidneyweights00135209AcceptableUSEPA 2004cChronic Toxicity Rat TGAI 2 year NOAEL/LOAEL7.65/25.15 mg/kg/day (body weight92% of control)25.15/80.8 mg/kg/day (Body weightwas 59-89% of control, and increasedincidence of small testes, enlarged andgranular kidneys, opaque, cloudyulcerated eyes, and skin nodules andmasses observed. The effects weredose related.)00103305Acceptable(U.E. EPA2004bReproduction andFertility EffectsRat (wistar) TGAI 3 generationreproductionstudyNOAEL=36mg/kg/dayLOAEL=112mg/kg/dayDecrease in pupweight on lactationday 2100103304Acceptable(USEPA 2004c)Acute dietary Rabbit TGAI LOAEL = 300mg/kg/dayNOAEL = 125mg/kg/dayIncreased incidenceof abortions00103302Acceptable(USEPA 2004c)Exposed days 6-18 of gestation. 4/14aborted between days 20 and 25 ofgestation, decreased body weight alsoobserved.Chronic Dietary ICR MiceTGAI 2 year dietaryLOAEL = 50mg/kg/dayNOAEL = 15mg/kg/dayIncreased alkalinephosphatase andhepatocelluarhyperplasia00103335Acceptable(USEPA 2004c)USEPA 2004bAvianAcute Oral Bobwhite Quail TGAI LD50> 2000 None observed 00121686 MRID and DER do not specify75 of 80Study TypeTest SpeciesTGAI orEPToxicityEndpoint(95% C.I.)(Measured/Nominal)/SlopeEffectMRID (Year)Classification,DER date orsourceComments(Colinusvirginianus)Age=8 mos.bw=198.1±5.6g95-97 mg/kg-bw(nominal)(1978)Acceptable, DER09/18/1978whether the 2000 mg/kg is for bodyweight or diet. Assumed body weight.Acute Dietary Bobwhite Quail(Colinusvirginianus)Age = 10 daysbw = 15.9 ±0.4gTGAI95-978-day LC50>4390 mg/kg-dietLOAEL = 2500mg/kg-diet (bodyweight)(measured)No mortalityobserved00121687(1978)Acceptable, DER9/16/7810 birds per treatment group.A statistically significant reduced bodyweight was observed at 2500 and 5000mg/kg-diet. Reduced foodconsumption observed.Acute Dietary Mallard Duck(Anasplatyrhynchos)Age = 16 daybw=280.2±6.4gTGAI95-978-day LC50>4540 mg/kg-diet,LOAEL = 1580mg/kg-diet (bodyweight)No mortalityobserved00135211(1978)Acceptable DER9/16/78Only 8 birds in each group. EPArecommends a minimum of 10 birdsper replicate. Food consumption wasreduced, possibly due to rejection, astatistically significant reduction inbody weight was observed for alltreatment levels. MRID 00135211,00121688, and 00135370 are the samestudy with DER listed for 00135211.Reproductive Bobwhite Quail(Colinusvirginianus)Age = 17 wksTGAI99.700103293(1982)InvalidDER Addendum09/01/2009A statistically significant increase inthe number of eggs set and hatchabilitywere larger in the highest treatmentgroup when compared to controls. Allbirds showed very poor egg productionand a high percentage of cracked eggs,especially for the control group. Thiscould indicate that presence of poorhusbandry practices. Percenthatchability decreased with dose butonly significantly different fromcontrols at lowest treatment level76 of 80Study TypeTest SpeciesTGAI orEPToxicityEndpoint(95% C.I.)(Measured/Nominal)/SlopeEffectMRID (Year)Classification,DER date orsourceCommentsbecause the control group had thelowest hatchability.Reproductive Mallard Duck(Anasplatyrhynchos)Age = 13 wksMale bw =1114±14 gFemale bw =976±9gTGAI99.700103294(1981)InvalidDER Addendum09/01/20094 pens each with 2 males and 5females. Sixteen adult mortalitiesobserved 3-4 birds in each treatmentand control group. There wereindications of stress on birds fromhousing conditions (e.g., overcrowdingand bacterial infections). Thepercentages of cracked eggs werehigher than normal for the control andlowest treatment level. Greater than10% mortality was observed incontrols.Terrestrial InvertebratesAcute ContactHoney Bee(Apis melliferaL.)EP33.3Highest testconcentration =362.58μg/beeNo mortality 00103295(1982)AcceptableDER 7/16/82Bees were exposed to direct applicationof fluridone in combination with a nontoxic dust carrier.EarthwormAcute/subchronicEarthworm(Eisenia fetida)TGAI95-97102.6 ppm wasthe highest testedconcentrationNo mortalityobserved00121692(1978)SupplementalDER 9/18/1978Earthworms exposed to 10.3 and 102.6ppm of fluridone for 14 days had nomortality. A few treated worms hadslight changes in appearance.Abbreviations: TGAI = technical grade active ingredient; EP=end use product; conc.=concentration77 of 80 Appendix C: Preliminary TREX Output for NMF

The application rate was estimat ed using the following equation:

Parent application rate (lbs ai/A) x Maximum Percent NMF pa rent equivalents in photolysis study x Molecular weight of NM F ÷ molecular weight of pare nt = 4.9 lbs ai/A x 0.74 x 59.07 g/mole ÷ 329.30 g/mole = 0.65 lbs NMF /A78 of 8079 of 80 Appendix D: ECOSAR (version 1.0) Result s for 3-trifluoromethyl benzoic acid

SMILES : OC(=O)c1cccc(c1)C(F)(F)F

CHEM :

CAS Num:

ChemID1:

ChemID2:

ChemID3:

MOL FOR: C8 H5 F3 O2

MOL WT : 190.12 Log Kow: 2.84 (KowWin estimate)

Melt Pt: Wat Sol: 148.5 mg/L (WskowWin estimate)

ECOSAR v1.00 Class(es) Found

------------------ ------------ Neutral Organics-acid

Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm)

========================= == ================== ======== ======

========== --> Acid moeity found: Pred icted values multiplied by 10

Neutral Organics-acid : Fish 96-hr LC50 268.600 * Neutral Organics-acid : Fish 14-day LC50 275.276 * Neutral Organics-acid : Daphnid 48-hr LC50 171.422 * Neutral Organics-acid : Green Algae 96-hr EC50 117.058 Neutral Organics-acid : Fish 30-day ChV 29.599 Neutral Organics-acid : Da phnid ChV 22.692 Neutral Organics-acid : Green Algae ChV 51.431 Neutral Organics-acid : Fish (SW) 96-hr LC50 350.406 * Neutral Organics-acid : Mysid Shrimp 96-hr LC50 147.394 Neutral Organics-acid : Fish (SW) ChV 63.303 Neutral Organics-acid : Mysid Shrimp (S W) ChV 9.940 Neutral Organics-acid : Earthworm 14-day LC50 2706.424 *

Note: * = asterisk designates: Chemical may not be soluble enough to measure this predicted effect.

Neutral Organics:

---------------- For Fish LC50 (96-h), Daphnid LC50, Mysid: If the log Kow is greater than 5.0, or if the compound is so lid and the LC50 exceeds the water solubility by 10X, no effects at saturation are predicted.80 of 80 For Fish LC50 (14-day) and Earthw orm LC50: If the log Kow is greater than 6.0, or if the compound is so lid and the LC50 exceeds the water solubility by 10X, no effects at saturation are predicted.

For Green Algae Acute Toxicity Values : If the log Kow of the chemical is greater than 6.4, or if the compound is solid and the EC50 exceeds the water solubility by 10X, no effects at satura tion are predicted for these endpoints.

For All Chronic Toxicity Values: If the log Kow of the chemical is greater than 8.0, or if the compound is solid a nd the ChV exceeds the water solubility by 10X, no effects at saturation ar e predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

--------------- ------------- Maximum LogKow: 5.0 (Fish 96-hr LC50; Daphnid LC50, Mysid LC50) Maximum LogKow: 6.0 (Fish 14-day LC50; Earthworm LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000