Risks of Pendimethalin Use to Federally Threatened California Red-legged Frog (Rana aurora draytonii) Pesticide Effects Determination Environmental Fate and Effects Division Office of Pesticide Programs Washington, D.C. 20460 June 16,2009 ------- Primary Authors: Michael Davy, Agronomist William P. Eckel, Ph.D., Physical Scientist Secondary Review: Jean Holmes, DVM,MPH Risk Assessment Process Leader Final Review: Tom Bailey, Ph.D., Branch Chief Environmental Risk Assessment Branch 2 ------- Table of Contents 1.0 Executive Summary 10 2.0 Problem Formulation 15 2.1 Purpose 15 2.2 Scope 17 2.3 Previous Assessments 18 2.4 Stressor Source and Distribution 19 2.4.1 Environmental Fate Assessment 19 2.4.2 Mechanism of Action 21 2.4.3 Use Characterization 22 2.5 Assessed Species 28 2.5.1 Distribution 28 2.5.2 Reproduction 31 2.5.3 Diet 31 2.5.4 Habitat 32 2.6 Designated Critical Habitat 33 2.7 Action Area 35 2.8 Assessment Endpoints and Measures of Ecological Effect 39 2.8.1 Assessment Endpoints for the CRLF 39 2.8.2 Assessment Endpoints for Designated Critical Habitat 41 2.9 Conceptual Model 43 2.9.1 Risk Hypotheses 43 2.9.2 Diagram 43 2.10 Analysis Plan 45 2.10.1 Measures to Evaluate the Risk Hypothesis and Conceptual Model 46 2.10.1.1 Measures of Exposure 46 2.10.1.2 Measures of Effect 48 2.10.1.3 Integration of Exposure and Effects 49 3.0 Exposure Assessment 49 3.1 Label Application Rates and Intervals 50 3.2 Aquatic Exposure Assessment 51 3.2.1 Modeling Approach 51 3.2.2 Model Inputs 52 3.2.3 Results 53 3.2.4 Existing Monitoring Data 54 3.2.4.1USGSNAWQA Surface Water Data 54 3.2.4.2 USGS NAWQA Groundwater Data 54 3.2.4.3 California Department of Pesticide Regulati on (CPR) Data 55 3.2.4.4 Atmospheric Monitoring Data 56 3.2.4.5 Spray Drift Buffer and Downstream Dilution Analysis for Action Area. 56 3.3 Terrestrial Animal Exposure Assessment 57 3.4 Terrestrial Plant Exposure Assessment 59 4.0 Effects Assessment 60 4.1 Evaluation of Aquatic Ecotoxicity Studies 62 4.1.1 Toxicity to Freshwater Fish 63 ------- 4.1.1.1 Freshwater Fish: Acute Exposure (Mortality) Studies 63 4.1.1.2 Freshwater Fish: Chronic Exposure (Early Life Stage and Reproduction) Studies 64 4.1.1.3 Freshwater Fish: Sublethal Effects and Additional Open Literature Information 64 4.1.1.4 Aquatic-phase Amphibian: Acute and Chronic Studies 64 4.1.2 Toxicity to Freshwater Invertebrates 65 4.1.2.1 Freshwater Invertebrates: Acute Exposure (Mortality) Studies 65 4.1.2.2 Freshwater Invertebrates: Chronic Exposure (Reproduction) Studies 65 4.1.2.3 Freshwater Invertebrates: Sublethal Effects and Open Literature Data.... 66 4.1.3 Toxicity to Aquatic Plants 66 4.1.3.1 Aquatic Plants: Laboratory Data 66 4.1.3.2 Freshwater Field Studies 67 4.2 Toxicity of Pendimethalin to Terrestrial Organisms 67 4.2.1 Toxicity to Birds 68 4.2.1.1 Birds: Acute Exposure (Mortality) Studies 69 4.2.1.2 Birds: Chronic Exposure (Growth, Reproduction) Studies 69 4.2.1.3 Birds: Open Literature Studies 69 4.2.2 Toxicity to Mammals 69 4.2.2.1 Mammals: Acute Exposure (Mortality) Studies 70 4.2.2.2 Mammals: Chronic Exposure (Growth, Reproduction) Studies 70 4.2.2.3 Mammals: Open Literature Studies 70 4.2.3 Toxicity to Terrestrial Invertebrates 70 4.2.3.1 Terrestrial Invertebrates: Acute Exposure (Mortality) Studies 70 4.2.3.2 Terrestrial Invertebrates: Open Literature Studies 71 4.2.4 Toxicity to Terrestrial Plants 71 4.3 Use of Probit Slope Response Relationship to Provide Information on the Endangered Species Levels of Concern 72 4.4 Incident Database Review 73 4.4.1 Terrestrial Incidents 73 4.4.2 Plant Incidents 74 4.4.3 Aquatic Incidents 74 5.0 Risk Characterization 76 5.1 Risk Estimation 76 5.1.1 Exposures in the Aquatic Habitat 76 5.1.1.1 Direct Effects to Aquatic-Phase CRLF 76 5.1.1.2 Indirect Effects to Aquatic-Phase CRLF via Reduction in Prey (non- vascular aquatic plants, aquatic invertebrates, fish, and frogs) 78 5.1.1.3 Indirect Effects to CRLF via Reduction in Habitat and/or Primary Productivity (Freshwater Aquatic Plants) 80 5.1.2 Exposures in the Terrestrial Habitat 80 5.1.2.1 Direct Effects to Terrestrial-phase CRLF 80 5.1.2.2 Indirect Effects to Terrestrial-Phase CRLF via Reduction in Prey (terrestrial invertebrates, mammals, and frogs) 83 5.1.2.3 Indirect Effects to CRLF via Reduction in Terrestrial Plant Community (Riparian and Upland Habitat) 86 ------- 5.1.3 Primary Constituent Elements of Designated Critical Habitat 88 5.1.3.1 Aquatic-Phase (Aquatic Breeding Habitat and Aquatic Non-Breeding Habitat) 88 5.1.3.2 Terrestrial-Phase (Upland Habitat and Dispersal Habitat) 89 5.2 Risk Description 90 5.2.1 Direct Effects 93 5.2.1.1 Aquatic-Phase CRLF 93 5.2.1.2 Terrestrial-Phase CRLF 94 5.2.2 Indirect Effects (via Reductions in Prey Base) 98 5.2.2.1 Algae (non-vascular plants) 98 5.2.2.2 Aquatic Invertebrates 99 5.2.2.3 Fish and Aquatic-phase Frogs 100 5.2.2.4 Terrestrial Invertebrates 100 5.2.2.5 Mammals 101 5.2.2.6 Terrestrial-phase Amphibians 102 5.2.3 Indirect Effects (via Habitat Effects) 102 5.2.3.1 Aquatic Plants (Vascular and Non-vascular) 102 5.2.3.2 Terrestrial Plants 103 5.2.4 Effects to Designated Critical Habitat 104 5.2.4.1 Aquatic-Phase PCEs 104 5.2.4.2 Terrestrial-Phase PCEs 105 5.2.5 Spatial Extent of Potential Effects 106 5.2.5.1 Spray Drift 106 5.2.5.2 Downstream Dilution Analysis 108 5.2.5.3 Overlap between CRLF habitat and Spatial Extent of Potential Effects 108 6.0 Uncertainties Ill 6.1 Exposure Assessment Uncertainties Ill 6.1.1 Maximum Use Scenario Ill 6.1.2 Aquatic Exposure Modeling of Pendimethalin Ill 6.1.3 Usage Uncertainties 113 6.1.4 Terrestrial Exposure Modeling of Pendimethalin 113 6.1.5 Spray Drift Modeling 114 6.1.6 Volatility 115 6.1.7 Bioaccumulation 115 6.2 Effects Assessment Uncertainties 116 6.2.1 Age Class and Sensitivity of Effects Thresholds 116 6.2.2 Use of Surrogate Species Effects Data 116 6.2.3 Sublethal Effects 116 6.2.4 Location of Wildlife Species 117 7.0 Risk Conclusions 117 8.0 References 121 ------- List of Tables Table 1-1 Effects Determination Summary for Pendimethalin Use and the CRLF 13 Table 1-2 Effects Determination Summary for Pendimethalin Use and CRLF Critical Habitat Impact Analysis 13 Table 2-1 Summary of Pendimethalin Environmental Fate Properties 20 Table 2-2 Pendimethalin Uses Assessed for the CRLF 22 Table 2-3 Summary of California Department of Pesticide Registration (CDPR) Pesticide Use Reporting (PUR) Data from 1994 to 2006 for Currently Registered Pendimethalin Uses: By County 26 Table 2-4 Assessment Endpoints and Measures of Ecological Effects 40 Table 2-5 Summary of Assessment Endpoints and Measures of Ecological Effect for Primary Constituent Elements of Designated Critical Habitata 42 Table 3-1 Pendimethalin Uses, Scenarios, and Application Information for the CRLF risk assessment1 50 Table 3-2 Summary of PRZM/EZAMS Environmental Fate Data Used for Aquatic Exposure Inputs for Pendimethalin Endangered Species Assessment for the CRLF1 52 Table 3-3 Aquatic EECs (ug/L) for Pendimethalin Uses in California 53 Table 3-4 Input Parameters for Foliar Applications Used to Derive Terrestrial EECs for Pendimethalin with T-REX 57 Table 3-5 Upper-bound Kenega Nomogram EECs for Dietary- and Dose-based Exposures of the CRLF and its Prey to Pendimethalin 58 Table 3-6 EECs (ppm) for Indirect Effects to the Terrestrial-Phase CRLF via Effects to Terrestrial Invertebrate Prey Items 58 Table 3-7 TerrPlant Inputs and Resulting EECs for Plants Inhabiting Dry and Semi- aquatic Areas Exposed to Pendimethalin via Runoff and Drift 59 Table 4-1 Freshwater Aquatic Toxicity Profile for Pendimethalin 62 Table 4-2 Categories of Acute Toxicity for Fish and Aquatic Invertebrates 63 Table 4-3. Terrestrial Toxicity Profile for Pendimethalin 67 Table 4-4 Categories of Acute Toxicity for Avian and Mammalian Studies 68 Table 4-5 Non-target Terrestrial Plant Seedling Emergence and Vegetative Vigor Toxicity (Tier II) Data 71 Table 5-1 Summary of Direct Effect RQsa for the Aquatic-phase CRLF 77 ------- Table 5-2 Summary of RQs Used to Estimate Indirect Effects to the CRLF via Effects to Non-Vascular Aquatic Plants a (diet of CRLF in tadpole life stage and habitat of aquatic-phase CRLF) 78 Table 5-3 Summary of Acute and Chronic RQsa Used to Estimate Indirect Effects to the CRLF via Direct Effects on Aquatic Invertebrates as Dietary Food Items (prey of CRLF juveniles and adults in aquatic habitats) 79 Table 5-4 Summary of RQs Used to Estimate Indirect Effects to the CRLF via Effects to Vascular Aquatic Plants (habitat of aquatic-phase CRLF)a 80 Table 5-5 Summary of Acute RQs* Used to Estimate Direct Effects to the Terrestrial- phase CRLF 81 Table 5-6 Summary of Chronic RQs* Used to Estimate Direct Effects to the Terrestrial- phase CRLF 82 Table 5-7 Summary of RQs Used to Estimate Indirect Effects to the Terrestrial-phase CRLF via Direct Effects on Terrestrial Invertebrates as Dietary Food Items 83 Table 5-8 Summary of Acute and Chronic RQs* Used to Estimate Indirect Effects to the Terrestrial-phase CRLF via Direct Effects on Small Mammals as Dietary Food Items 85 Table 5-9 RQs* for Monocots Inhabiting Dry and Semi-Aquatic Areas Exposed to Pendimethalin via Runoff and Drift 86 Table 5-10 RQs* for Dicots Inhabiting Dry and Semi-Aquatic Areas Exposed to Pendimethalin via Runoff and Drift 87 Table 5-11 Risk Estimation Summary for Pendimethalin - Direct and Indirect Effects to CRLF 90 Table 5-12 Risk Estimation Summary for Pendimethalin - PCEs of Designated Critical Habitat for the CRLF 91 Table 5-13 Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (1 Ibs a.i./acre, 1 application) 96 Table 5-14 Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (1.24 Ibs a.i./acre, 1 application) 96 Table 5-15. Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (1.425 Ibs a.i./acre, 1 application) 96 Table 5-16. Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (6 Ibs a.i./Acre, 1 application) 96 Table 5-17 RQ Comparisons among Weight Class and Applications Rates for CRLF Consuming Small Herbivore Mammal That Recently Consumed Contaminated Short Grass 97 Table 5-18. Range of Risk Quotients for Non-Target Terrestrial Plants from Pendimethalin Usage 103 Table 5-19 Summary of AgDrift Predicted Terrestrial Spray Drift Distances 107 ------- Table 5-20 Summary of AgDrift Predicted Aquatic Spray Drift Distances 107 Table 7-1 Effects Determination Summary for Pendimethalin Use and the CRLF 118 Table 7-2 Effects Determination Summary for Pendimethalin Use and CRLF Critical Habitat Impact Analysis 119 ------- List of Figures Figure 2.1 Pendimethalin Use in Total Pounds per County 24 Figure 2.2 Recovery Unit, Core Area, Critical Habitat, and Occurrence Designations for CRLF 30 Figure 2.3 CRLF Reproductive Events by Month 31 Figure 2.4. Initial area of concern, or "footprint" of potential use, for Pendimethalin.... 37 Figure 2.5 Conceptual Model for Pesticide Effects on Terrestrial Phase of the CRLF... 44 Figure 2.6 Conceptual Model for Pesticide Effects on Aquatic Phase of the CRLF 45 Appendices Appendix A Ecological Effects Data Appendix B Multi-ai Product Analysis Pendimethalin Appendix C RQ Method and LOCs Appendix D CRLF Spatial Summary Pendimethalin Appendix E T-REX Output Appendix F TerrPlant Output Appendix G ECOTOX Bibliography Appendix H Accepted ECOTOX Data Table Appendix I FLED Effects Pendimethalin Appendix J PRZM-EXAMS Output Appendix K KABAM Model Output Attachment I. Status and Life History of the California Red-legged Frog Attachment II. Baseline Status and Cumulative Effects for the California Red-legged Frog ------- 1.0 Executive Summary The purpose of this assessment is to evaluate potential direct and indirect effects on the California red-legged frog (Rana aurora draytonii) (CRLF) arising from FIFRA regulatory actions regarding use of pendimethalin on agricultural and non-agricultural sites. In addition, this assessment evaluates whether these actions can be expected to result in effects to the species' designated critical habitat. This assessment was completed in accordance with the U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS) Endangered Species Consultation Handbook (USFWS/NMFS, 1998 and procedures outlined in the Agency's Overview Document (U.S. EPA, 2004). The CRLF was listed as a threatened species by USFWS in 1996. The species is endemic to California and Baja California (Mexico) and inhabits both coastal and interior mountain ranges. A total of 243 streams or drainages are believed to be currently occupied by the species, with the greatest numbers in Monterey, San Luis Obispo, and Santa Barbara counties (USFWS, 1996) in California. The following uses are considered as part of the federal action evaluated in this assessment: alfalfa, lupine for seed, almond, beech nut, brazil nut, butternut, cashew, chestnut, chinquapin, filbert (hazelnut), hickory nut, macadamia nut (bushnut), mayhaw (hawthorn), pecan, pistachio, walnut (English/black), calamondin, citron (citrus), citrus, citrus hybrids other than tangelo, grapefruit, kumquat, lemon, lime, orange, pummelo (shaddock), tangelo, tangerines, Brassica (head and stem) vegetables, broccoli, broccoli (Chinese), brussels sprouts, cabbage, cabbage (Chinese), cauliflower, kohlrabi, mustard cabbage (gai choy - pak-choi), corn (field, pop, sweet), sunflower, cotton, forest trees (all species), Christmas tree plantations, apple, apricot, cherry, crabapple, fig, loquat, nectarine, peach, pear, pepino (melon pear), plum, plum (Japanese), pomegranate, prune, quince, small fruits, garlic, leek, grapes, eggplant, olive, onion (green, scallions, spring), shallot, potato (white/Irish), nonagricultural rights-of-way/fencerows/hedgerows, artichoke, asparagus, beans (dry, succulent/lima/snap), carrot (including tops), garbanzos (including chick peas), legume vegetables, lentils, peanuts, peas (dry, early dwarf, pigeon, southern/cowpea), pepper, strawberry, tomato, groundcherry (strawberry tomato, tomatillo), airports/landing fields, commercial/industrial lawns, golf course turf, industrial areas (outdoor), ornamental and/or shade trees, ornamental ground cover, ornamental herbaceous plants, ornamental lawns and turf, ornamental nonflowering plants, ornamental sod farm (turf), ornamental woody shrubs and vines, recreation area lawns, residential lawns, shelterbelt plantings, sorghum, wheat, and rice. Ground and aerial spray applications of pendimethalin (including some forms of chemigation) will potentially result in spray drift onto non-target plants, soil, and water adjacent to a treated field. Pendimethalin is expected to be persistent in the terrestrial environment and under the right conditions, may accumulate in the soil with repeated applications resulting in the potential for pendimethalin to reach the aquatic environment on suspended soil in runoff water. Laboratory dissipation studies in soil under aerobic 10 ------- conditions, demonstrate a half-life of approximately 72-172 days, and field dissipation studies in the Midwest similarly had half-lives that ranged from 84-147 days. However, field dissipation studies in Louisiana and Mississippi had half-lives of <20 days, demonstrating that pendimethalin can be relatively short-lived under some environmental conditions. Field half-lives less than 20 days may be due to volatilization, which has a measured half-life of 12.5 days in moist soil. In laboratory studies, pendimethalin can photodegrade in water with a half-life of approximately 42 days. However, in the environment, pendimethalin will not be available for photodegradation because the pendimethalin in water will tend to sorb to soil or sediment particles as indicated by Koc's which range from 13000-29400 ml/g. Thus, pendimethalin is considered hardly mobile according to FAO classification. Pendimethalin may accumulate in fish based on submitted data. Pendimethalin residues accumulated in bluegill sunfish exposed to 3 ppb of pendimethalin, with BCFs of 1400X for edible, 5800X for nonedible, and 5100X for whole fish. Depuration was rapid, with 87- 91% of the 14C-residues eliminated from the fish tissues by 14 days of depuration. The major terminal degradates in terrestrial environments include several compounds formed at insignificant levels (<10 % of applied). Therefore, no degradates are included in the definition of the chemical stressor. Since CRLFs exist within aquatic and terrestrial habitats, exposure of the CRLF and its prey to pendimethalin are assessed separately for the two habitats. Tier-II aquatic exposure models are used to estimate high-end exposures of pendimethalin in aquatic habitats resulting from runoff and spray drift from different uses. Peak model-estimated environmental concentrations resulting from different pendimethalin uses range from 1.74 ppb (rights-of-way/impervious) to 16.6 |ig/L (forestry) and 48 ppb (rice paddies). These estimates are supplemented with analysis of available California surface water monitoring data from U. S. Geological Survey's National Water Quality Assessment (NAWQA) program and the California Department of Pesticide Regulation. The maximum concentration of pendimethalin reported by NAWQA for California surface waters with agricultural watersheds is 0.68 |ig/L. This value is approximately 71 times less than the maximum model-estimated environmental concentration. The maximum concentration of pendimethalin reported by the California Department of Pesticide Regulation surface water database (3.5 |ig/L) is roughly 14 times lower than the highest peak model-estimated environmental concentration. To estimate pendimethalin exposures to the terrestrial-phase CRLF, and its potential prey resulting from uses involving pendimethalin applications, the T-REX model is used for foliar uses. AgDRIFT and AGDISP models are also used to estimate deposition of pendimethalin on terrestrial and aquatic habitats from aerial and ground spray drift. The TerrPlant model is used to estimate pendimethalin exposures to terrestrial-phase CRLF habitat, including plants inhabiting semi-aquatic and dry areas, resulting from uses involving foliar pendimethalin applications. The T-HERPS model is used to allow for further characterization of dietary exposures of terrestrial-phase CRLFs relative to birds. 11 ------- The effects determination assessment endpoints for the CRLF include direct toxic effects on the survival, reproduction, and growth of the CRLF itself, as well as indirect effects, such as reduction of the prey base or modification of its habitat. Direct effects to the CRLF in the aquatic habitat are based on toxicity information for freshwater fish, which are generally used as a surrogate for aquatic-phase amphibians. In the terrestrial habitat, direct effects are based on toxicity information for birds, which are used as a surrogate for terrestrial-phase amphibians. Given that the CRLF's prey items and designated critical habitat requirements in the aquatic habitat are dependant on the availability of freshwater aquatic invertebrates and aquatic plants, toxicity information for these taxonomic groups is also discussed. In the terrestrial habitat, indirect effects due to depletion of prey are assessed by considering effects to terrestrial insects, small terrestrial mammals, and frogs. Indirect effects due to modification of the terrestrial habitat are characterized by available data for terrestrial monocots and dicots. Pendimethalin is stable to most of the environmental degradation processes measured, meaning there is little production of degradates. Thus, no degradates were considered in the assessment, which was based on parent pendimethalin alone. There was monitoring data for one possible degradate, 4-hydroxypendamethalin, in the NAWQA data. It was not detected (less than 0.143 ppb) in 61 ground water samples, and 8 surface water samples, all taken from the San Joaquin-Tulare Basin. Risk quotients (RQs) are derived as quantitative estimates of potential high-end risk. Acute and chronic RQs are compared to the Agency's levels of concern (LOCs) to identify instances where pendimethalin use within the action area has the potential to adversely affect the CRLF and its designated critical habitat via direct toxicity or indirectly based on direct effects to its food supply (i.e., freshwater invertebrates, algae, fish, frogs, terrestrial invertebrates, and mammals) or habitat (i.e., aquatic plants and terrestrial upland and riparian vegetation). When RQs for each particular type of effect are below LOCs, the pesticide is determined to have "no effect" on the CRLF. Where RQs exceed LOCs, a potential to cause adverse effects is identified, leading to a conclusion of "may affect." If a determination is made that use of pendimethalin use within the action area "may affect" the CRLF and its designated critical habitat, additional information is considered to refine the potential for exposure and effects, and the best available information is used to distinguish those actions that "may affect, but are not likely to adversely affect" (NLAA) from those actions that are "likely to adversely affect" (LAA) the CRLF. Based on the best available information, the Agency makes a May Affect and Likely to Adversely Affect determination for the CRLF from the use of pendimethalin. Additionally, the Agency has determined that there is the potential for effects to CRLF designated critical habitat from the use of the chemical. There is potential for direct and indirect effects to the aquatic-phase and terrestrial-phase CRLF from the use of pendimethalin. Potential effects to the habitat of the aquatic and terrestrial phase CRLF has been determined due to effects to terrestrial and aquatic non-target plants. A summary of the risk conclusions and effects determinations for the CRLF and its critical habitat is presented in Table 1-1 and Table 1-2. Further information on the results of the effects 12 ------- determination is included as part of the Risk Description in Section 5.2. Given the LAA determination for the CRLF and potential effects to designated critical habitat, a description of the baseline status and cumulative effects for the CRLF is provided in Attachment 2 Table 1-1 Effects Determination Summary for Pendimethalin Use and the CRLF Assessment Endpoint Survival, growth, and/or reproduction of CRLF individuals Effects Determination 1 LAA1 Basis for Determination Potential for Direct Effects Aquatic-phase (Eggs, Larvae, and Adults): Acute LOCs were exceeded for fish or aquatic-phase amphibians Terrestrial-phase (Juveniles and Adults): Acute and chronic LOCs were exceeded for birds. The available toxicity data suggest that amphibians are less sensitive than birds to pendimethalin, and considering factors such as lower food intake of terrestrial phase amphibians relative to birds reduces EECs and RQs, but does not reduce RQs to levels that are below LOCs. Likely to adversely affect CRLF. Potential for Indirect Effects Aquatic prey items, aquatic habitat, cover and/or primary productivity: LOG is exceeded only for non-vascular aquatic plants. RQs are below LOG for freshwater invertebrates (chronic and acute effects) and fish or frogs (chronic and acute effects). Pendimethalin could potentially impact terrestrial and aquatic plants to an extent that could result in indirect effects to the CRLF or effects to critical habitat. Terrestrial prey items, riparian habitat: Chronic LOG is exceeded for mammal and birds (surrogate for frog). Pendimethalin is practically non-toxic to honeybees with no mortalities observed in testing. LOG is exceeded for terrestrial invertebrates. Uncertainty in toxicity to insects from EEC that is above highest bee concentration tested does not preclude potential risk. Pendimethalin may adversely affect insects. Acute LOCs were not exceeded for insectivorous amphibians using the T-HERPS model at the highest rate of application. LOG is exceeded for non-target terrestrial plants and thereby critical habitat could be affected as a result of these potential impacts. 1 No effect (NE); May affect, but not likely to adversely affect (NLAA); May affect, likely to adversely affect (LAA) Table 1-2 Effects Determination Summary for Pendimethalin Use and CRLF Critical Habitat Impact Analysis Assessment Endpoint Effects Determination Basis for Determination Modification of aquatic-phase PCE Habitat effects Effects to riparian vegetation (terrestrial plants) and aquatic non-vascular and vascular plants result in LOG exceedances. These effects may indirectly affect the CRLF via reduction in food supply, changes in available cover, physical parameters of the waterbody (e.g. increase temperature or turbidity) LOG is exceeded for effects to non-vascular aquatic plants, freshwater invertebrates (chronic and acute effects) and fish or frogs (chronic and acute effects). 13 ------- Modification of terrestrial-phase PCE Effects to riparian vegetation (terrestrial plants) result in LOG exceedances. Effects may result in changes in community composition or relative abundance of riparian plant species, possibly altering terrestrial - phase CRLF habitat. Chronic LOG is exceeded for mammal. Although there are NLAA determinations for other prey items, small mammals constitute up to half of the food intake for CRLF and reduction in small mammalian populations may be significant. Based on the conclusions of this assessment, a formal consultation with the U. S. Fish and Wildlife Service under Section 7 of the Endangered Species Act should be initiated. When evaluating the significance of this risk assessment's direct/indirect and adverse habitat effects determinations, it is important to note that pesticide exposures and predicted risks to the species and its resources (i.e., food and habitat) are not expected to be uniform across the action area. In fact, given the assumptions of drift and downstream transport (i.e., attenuation with distance), pesticide exposure and associated risks to the species and its resources are expected to decrease with increasing distance away from the treated field or site of application. Evaluation of the implication of this non-uniform distribution of risk to the species would require information and assessment techniques that are not currently available. Examples of such information and methodology required for this type of analysis would include the following: • Enhanced information on the density and distribution of CRLF life stages within specific recovery units and/or designated critical habitat within the action area. This information would allow for quantitative extrapolation of the present risk assessment's predictions of individual effects to the proportion of the population extant within geographical areas where those effects are predicted. Furthermore, such population information would allow for a more comprehensive evaluation of the significance of potential resource impairment to individuals of the species. • Quantitative information on prey base requirements for individual aquatic- and terrestrial-phase frogs. While existing information provides a preliminary picture of the types of food sources utilized by the frog, it does not establish minimal requirements to sustain healthy individuals at varying life stages. Such information could be used to establish biologically relevant thresholds of effects on the prey base, and ultimately establish geographical limits to those effects. This information could be used together with the density data discussed above to characterize the likelihood of adverse effects to individuals. • Information on population responses of prey base organisms to the pesticide. Currently, methodologies are limited to predicting exposures and likely levels of direct mortality, growth or reproductive impairment immediately following exposure to the pesticide. The degree to which repeated exposure events and the inherent demographic characteristics of the prey population play into the extent to which prey resources may recover is not predictable. An enhanced understanding of long-term prey responses to pesticide exposure would allow for a more refined 14 ------- determination of the magnitude and duration of resource impairment, and together with the information described above, a more complete prediction of effects to individual frogs and potential modification to critical habitat. 2.0 Problem Formulation Problem formulation provides a strategic framework for the risk assessment. By identifying the important components of the problem, it focuses the assessment on the most relevant life history stages, habitat components, chemical properties, exposure routes, and endpoints. The structure of this risk assessment is based on guidance contained in U.S. EPA's Guidance for Ecological Risk Assessment (U.S. EPA 1998), the Services' Endangered Species Consultation Handbook (USFWS/NMFS 1998) and is consistent with procedures and methodology outlined in the Overview Document (U.S. EPA 2004) and reviewed by the U.S. Fish and Wildlife Service and National Marine Fisheries Service (USFWS/NMFS 2004). 2.1 Purpose The purpose of this endangered species assessment is to evaluate potential direct and indirect effects on individuals of the federally threatened California red-legged frog (Rana aurora draytonii) (CRLF) arising from FIFRA regulatory actions regarding use of pendimethalin on alfalfa, lupine for seed, almond, beech nut, brazil nut, butternut, cashew, chestnut, chinquapin, filbert (hazelnut), hickory nut, macadamia nut (bushnut), mayhaw (hawthorn), pecan, pistachio, walnut (English/black), calamondin, citron (citrus), citrus, citrus hybrids other than tangelo, grapefruit, kumquat, lemon, lime, orange, pummelo (shaddock), tangelo, tangerines, Brassica (head and stem) vegetables, broccoli, broccoli (Chinese), brussels sprouts, cabbage, cabbage (Chinese), cauliflower, kohlrabi, mustard cabbage (gai choy - pak-choi), corn (field, pop, sweet), sunflower, cotton, forest trees (all species), Christmas tree plantations, apple, apricot, cherry, crabapple, fig, loquat, nectarine, peach, pear, pepino (melon pear), plum, plum (Japanese), pomegranate, prune, quince, small fruits, garlic, leek, grapes, eggplant, olive, onion (green, scallions, spring), shallot, potato (white/Irish), nonagricultural rights-of- way/fencerows/hedgerows, artichoke, asparagus, beans (dry, succulent/lima/snap), carrot (including tops), garbanzos (including chick peas), legume vegetables, lentils, peanuts, peas (dry, early dwarf, pigeon, southern/cowpea), pepper, strawberry, tomato, groundcherry (strawberry tomato, tomatillo), airports/landing fields, commercial/industrial lawns, golf course turf, industrial areas (outdoor), ornamental and/or shade trees, ornamental ground cover, ornamental herbaceous plants, ornamental lawns and turf, ornamental nonflowering plants, ornamental sod farm (turf), ornamental woody shrubs and vines, recreation area lawns, residential lawns, shelterbelt plantings, sorghum, wheat, and rice. In addition, this assessment evaluates whether use on these sites is expected to result in effects to the species' designated critical habitat. This ecological risk assessment has been prepared consistent with a settlement agreement in the case Center for Biological Diversity (CBD) vs. EPA et al. (Case No. 02-1580- JSW(JL)) entered in Federal District Court for the Northern District of California on October 20, 2006. 15 ------- In this assessment, direct and indirect effects to the CRLF and potential effects to its designated critical habitat are evaluated in accordance with the methods described in the Agency's Overview Document (U.S. EPA 2004). Screening level methods include use of standard models such as PRZM-EXAMS, T-REX, TerrPlant, AgDRIFT, and AGDISP, all of which are described at length in the Overview Document. Additional refinements include an analysis of the usage data, consideration of available monitoring data, a spatial analysis, and use of the T-HERPS model. Use of such information is consistent with the methodology described in the Overview Document (U.S. EPA 2004), which specifies that "the assessment process may, on a case-by-case basis, incorporate additional methods, models, and lines of evidence that EPA finds technically appropriate for risk management objectives" (Section V, page 31 of U.S. EPA 2004). In accordance with the Overview Document, provisions of the ESA, and the Services' Endangered Species Consultation Handbook, the assessment of effects associated with registrations of pendimethalin is based on an action area. The action area is the area directly or indirectly affected by the federal action. It is acknowledged that the action area for a national-level FIFRA regulatory decision associated with a use of pendimethalin may potentially involve numerous areas throughout the United States and its Territories. However, for the purposes of this assessment, attention will be focused on relevant sections of the action area including those geographic areas associated with locations of the CRLF and its designated critical habitat within the state of California. As part of the "effects determination," one of the following three conclusions will be reached regarding the potential use of pendimethalin in accordance with current labels: • "No effect"; • "May affect, but not likely to adversely affect"; or • "May affect and likely to adversely affect". Designated critical habitat identifies specific areas that have the physical and biological features, (known as primary constituent elements or PCEs) essential to the conservation of the listed species. The PCEs for CRLF are aquatic and upland areas where suitable breeding and non-breeding aquatic habitat is located, interspersed with upland foraging and dispersal habitat. If the results of initial screening-level assessment methods show no direct or indirect effects (no LOG exceedances) upon individual CRLF or upon the PCEs of the species' designated critical habitat, a "no effect" determination is made for use of pendimethalin as it relates to this species and its designated critical habitat. If, however, potential direct or indirect effects to individual CRLF are anticipated or effects may impact the PCEs of the CRLF's designated critical habitat, a preliminary "may affect" determination is made for the FIFRA regulatory action regarding pendimethalin. If a determination is made that use of pendimethalin within the action area(s) associated with the CRLF "may affect" this species or its designated critical habitat, additional information is considered to refine the potential for exposure and for effects to the CRLF 16 ------- and other taxonomic groups upon which these species depend (e.g., aquatic and terrestrial vertebrates and invertebrates, aquatic plants, riparian vegetation, etc.). Additional information, including spatial analysis (to determine the geographical proximity of CRLF habitat and pendimethalin use sites) and further evaluation of the potential impact of pendimethalin on the PCEs is also used to determine whether effects to designated critical habitat may occur. Based on the refined information, the Agency uses the best available information to distinguish those actions that "may affect, but are not likely to adversely affect" from those actions that "may affect and are likely to adversely affect" the CRLF or affect the PCEs of its designated critical habitat. This information is presented as part of the Risk Characterization in Section 5 of this document. The Agency believes that the analysis of direct and indirect effects to listed species provides the basis for an analysis of potential effects on the designated critical habitat. Because pendimethalin is expected to directly impact living organisms within the action area (defined in Section 2.7), critical habitat analysis for pendimethalin is limited in a practical sense to those PCEs of critical habitat that are biological or that can be reasonably linked to biologically mediated processes (i.e., the biological resource requirements for the listed species associated with the critical habitat or important physical aspects of the habitat that may be reasonably influenced through biological processes). Activities that may modify critical habitat are those that alter the PCEs and appreciably diminish the value of the habitat. Evaluation of actions related to use of pendimethalin that may alter the PCEs of the CRLF's critical habitat form the basis of the critical habitat impact analysis. Actions that may affect the CRLF's designated critical habitat have been identified by the Services and are discussed further in Section 2.6. 2.2 Scope As described above, the herbicide pendimethalin has a wide variety of outdoor uses, including both in agricultural and non-agricultural settings. The end result of the EPA pesticide registration process (i.e., the FIFRA regulatory action) is an approved product label. The label is a legal document that stipulates how and where a given pesticide may be used. Product labels (also known as end-use labels) describe the formulation type (e.g., liquid), acceptable methods of application, approved use sites, and any restrictions on how applications may be conducted. Thus, the use of pendimethalin in accordance with the approved product labels for California is "the action" relevant to this ecological risk assessment. Although current registrations of pendimethalin allow for use nationwide, this ecological risk assessment and effects determination addresses currently registered uses of pendimethalin in portions of the action area that are reasonably assumed to be biologically relevant to the CRLF and its designated critical habitat. Further discussion of the action area for the CRLF and its critical habitat is provided in Section 2.7. Degradates were not considered, as pendimethalin is relatively stable to all degradation processes measured. The half-lives used as model inputs reflect this stability and lack of 17 ------- degradate production. Sixty-nine measurements of one potential degradate (4- hydroxypendamthalin) in California waters produced no detections. The Agency does not routinely include, in its risk assessments, an evaluation of mixtures of active ingredients, either those mixtures of multiple active 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 containing more than one active ingredient), each active ingredient is subject to an individual risk assessment for regulatory decision regarding the active ingredient on a particular use site. If effects data are available for a formulated product containing more than one active ingredient, they may be used qualitatively or quantitatively in accordance with the Agency's Overview Document and the Services' Evaluation Memorandum (U.S., EPA 2004; USFWS/NMFS 2004). Pendimethalin has registered products that contain multiple active ingredients. Analysis of the available open literature and acute oral mammalian LD50 data for multiple active ingredient products relative to the single active ingredient is provided in Appendix B. The results of this analysis show that an assessment based on the toxicity of the single active ingredient of pendimethalin is appropriate. 2.3 Previous Assessments A Reregi strati on Eligibility Decision (RED) ecological risk chapter was completed in 1997. The RED concluded that pendimethalin would not represent a high acute risk to birds or a high acute or chronic risk to mammals. The chronic risk to birds could not be determined because avian reproduction studies had not been submitted. Chronic risk Levels of Concern (LOCs) for fish were exceeded by a small margin. But it was presumed that overall, pendimethalin did not represent a high risk to aquatic animals and plants, including estuarine organisms. The use of pendimethalin may adversely affect endangered species of terrestrial and semi-aquatic plants, aquatic plants and invertebrates including mollusks, fish, and birds (specifically grazers). The risk to nontarget terrestrial and semi-aquatic plants was expected to be moderate. On December 1, 2004, EPA initiated consultation with the National Marine Fisheries Service (NMFS) requesting concurrence in a determination relative to potential effects from pendimethalin uses to Pacific salmon and steelhead. In the assessment supporting that consultation, EPA concluded that pendimethalin has moderate to high laboratory toxicity to fish and aquatic invertebrates and somewhat less toxicity on aquatic plants. OPP determined that any effects of concern would be directly on listed salmon and steelhead and would vary for different uses and species. It was further determined that pendimethalin would not affect salmon and steelhead food or cover, nor adversely modify their Critical Habitat from any of the registered uses except a single aerial use - aerial application to corn. OPP's conclusions relative to 26 listed Pacific salmon and steelhead was that uses of pendimethalin were not likely to adversely affect four species and would have no effect on twenty-two species reviewed. A response to this request is anticipated from NMFS in 2012. 18 ------- 2.4 Stressor Source and Distribution 2.4.1 Environmental Fate Assessment The environmental fate properties of pendimethalin indicate that it is persistent, with half-lives in relevant compartments of 172 days (soil) and 208 to 330 days (anaerobic and aerobic aquatic systems). Only the aqueous photolysis half-life is relatively short (42 days) but photolysis may not occur because of the strong tendency of pendimethalin to sorb to sediment (log Kow = 5.18, average Koc = 17,040 mL/g O.C.). Pendimethalin may be bioaccumulative in aquatic organisms. A whole-body bioconcentration factor (BCF) of 5100 from a 35-day exposure was measured in bluegill sunfish. BCFs were lower in catfish (about 1600) and negligible in guppy. The most rapid dissipation process for pendimethalin appears to be volatilization from moist soil (half-life about 12.5 days). Thus, pendimethalin may be transported away from the site of application before it degrades, making atmospheric transport a potentially important exposure mechanism. However, EPISuite v4.0 (http://www.epa.gov/oppt/exposure/pubs/episuite.htm), an EPA-sponsored environmental fate estimation program, estimates of atmospheric half- life (4.2 hours due to reaction with hydroxyl radical, AOPWin program) and sorption to airborne particles (1 to 7%, AERO Win program) indicate that long-range transport may not be a concern. The tendency of pendimethalin to partition to sediment, and its long half-life there, make transport by movement of sediment in flowing water systems a concern. Table 2.1 lists the environmental fate properties of pendimethalin, along with the major and minor degradates detected in the submitted environmental fate and transport studies. 19 ------- Table 2-1 Summary of Pendimethalin Environmental Fate Properties Study Hydrolysis Direct Aqueous Photolysis Soil Photolysis Aerobic Soil Metabolism Anaerobic Soil Metabolism Anaerobic Aquatic Metabolism Aerobic Aquatic Metabolism Kd-ads / Kd.des (mL/g) TV" / "K" -"-oc- ads ' -"-oc-des (mL/g) Laboratory Volatility Fish Bioaccumulation Value (units) Stable Dark corrected, continuous irradiation half-life 21 days; 12-hour light/dark half-life 42 days. 16.5-day half-life Stable 172 day (Deviation from IPG, as explained in 1997 RED) Range 42-1322 days Stable 98% parent at 60 days 208-day half-life (upper 90th %ile confidence bound on mean) 330 days (single value) 30 - 854 (U.S. soils) 61 - 285 (Japanese soils) 17,040 mL/gO.C. (U.S. soils) (avg of 5 values, 13000 - 29400) 7011- 43863 mL/g o.c. (Japanese soils) Volatilization half-life 12.5 days from moist loam soil Bioconcentration factor BCF = 5 100, 35-day exposure Major Degradates Minor Degradates None 37 minor, unidentified degradates 2,6-dinitro-3,4- dimethylaniline (9.3% of applied) None 2, 6-dinitro3,4-xylidine 4-[(l -ethylpropyl) aminoJ-2- methyl-3, 5-dinitrobenzyl alcohol 4-[(l -ethylpropyl) aminoJ-2- methyl3, 5-dinitro-o-toluic acid 2, 6-dinitro3,4-xylidine 4-[(l -ethylpropyl) aminoJ-2- methyl-3, 5-dinitrobenzyl alcohol 4-[(l -ethylpropyl) aminoJ-2- methyl3, 5-dinitro-o-toluic acid None None n.a. None measured 4-[(l -ethylpropyl) aminoJ-2- methyl-3, 5-dinitrobenzyl alcohol (3.1%) MRID# 00106777 00153763 43808201 00153764 40185104 40185105 40813501 43154702 47385201 00153765 43041901 00153766 00156726 00158235 Study Status acceptable acceptable acceptable acceptable acceptable acceptable acceptable acceptable acceptable 20 ------- Study Terrestrial Field Dissipation Aquatic Field Dissipation Value (units) 34-day half-life in California almond orchard, sandy loam soil. No leaching below 6 inches. No data Major Degradates Minor Degradates MRID# 41722504 Study Status acceptable 2.4.2 Environmental Transport Assessment Potential transport mechanisms include pesticide surface water runoff, spray drift, and secondary drift of volatilized or soil-bound residues leading to deposition onto nearby or more distant ecosystems. Surface water runoff and spray drift are expected to be the major routes of exposure for pendimethalin. A number of studies have documented atmospheric transport and re-deposition of pesticides from the Central Valley to the Sierra Nevada Mountains (Fellers et al., 2004, Sparling et al., 2001, LeNoir et al., 1999, and McConnell et al., 1998). Prevailing winds blow across the Central Valley eastward to the Sierra Nevada Mountains, transporting airborne industrial and agricultural pollutants into the Sierra Nevada ecosystems (Fellers et al., 2004, LeNoir et al., 1999, and McConnell et al., 1998). Several sections of critical habitat for the CLRF are located east of the Central Valley. The magnitude of transport via secondary drift depends on the pendimethalin's ability to be mobilized into air and its eventual removal through wet and dry deposition of gases/particles and photochemical reactions in the atmosphere. Therefore, physicochemical properties of pendimethalin that describe its potential to enter the air from water or soil (e.g., Henry's Law constant and vapor pressure), pesticide use data, modeled estimated concentrations in water and air, and available air monitoring data from the Central Valley and the Sierra Nevadas are considered in evaluating the potential for atmospheric transport of pendimethalin to locations where it could impact the CRLF. In general, deposition of drifting or volatilized pesticides is expected to be greatest close to the site of application. Computer models of spray drift (AgDRIFT and/or AGDISP) are used to determine potential exposures to aquatic and terrestrial organisms via spray drift. 2.4.2 Mechanism of Action Pendimethalin is a selective herbicide registered for control of broadleaf weeds and grassy weed species on a variety of agricultural crops, turf, and ornamentals. Pendimethalin disrupts the process of mitosis in the growth of shoots and roots. It acts as a microtubule disrupter by inhibiting cell division and cell elongation in plants, and is generally applied early in the growing season. Absorption of the herbicide takes place at the roots and the shoots. Very little translocation occurs from the site of intake. 21 ------- 2.4.3 Use Characterization Pendimethalin is applied as a liquid spray formulation. Pendimethalin can be applied either by aerial equipment or using ground equipment to a variety of row crops, orchard crops, vineyards, sod, seed, and to rice. It can be broadcasted by air or ground, and be banded as a directed spray or applied by irrigation equipment in various crops. It can also be left on the soil surface or incorporated. Approximately 27 million pounds of pendimethalin were applied in 2002 according to the National Center for Food and Agriculture, and the majority was applied to soybeans (39.6%), cotton (20.22 %), and corn (19.4 %) (Fig. 2.1). Together, soybeans, cotton, and corn account for 79 % of the applied pendimethalin nationwide. This existing use information is provided as a basis for considering background exposures from existing use. Table 2.2 presents the uses and corresponding application rates and methods of application considered in this assessment. Table 2-2 Pendimethalin Uses Assessed for the CRLF Use walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of- way, fencerows, hedgerows, mulch, industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa Asparagus, artichoke golf course turf, airports/landing fields residential lawns Shallot, onion, com (sweet, pop, field) Carrot Sunflower Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, cowpea (southern pea, black-eyed bean), Max. Single Appl. Rate (Ib ai/A) 6.0 4.0 3.9 3.5 3.0 2.0 1.9 1.73 1.485 Max. Number of Application per Year 1 1 1 1 1 1 1 1 1 Application Method ground ground, aerial ground, aerial ground, aerial ground, aerial ground, aerial ground, aerial ground, aerial ground, aerial 22 ------- Use Wheat, pepper, pepino (melon pear), groundcherry, eggplant Strawberry Legume vegetables Rice, mustard cabbage (gai choy, pak-choi), kohlrabi, cauliflower, cabbage (Chinese), cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables Max. Single Appl. Rate (Ib ai/A) 1.425 1.485 1.24 1.0 Max. Number of Application per Year 1 2 1 1 Application Method ground, aerial ground, aerial ground, aerial ground, aerial 23 ------- The figure below summarizes pendimethalin use nationwide in 2002. Pendimethalin is used primarily on soybeans, cotton, corn, sugarcane, peanuts, rice, sunflower, potatoes, tobacco, and onions. Most use is apparently outside of California. Non-agricultural uses, which predominate in California, are not represented on this map. The map was downloaded from a U.S. Geological Survey (USGS), National Water Quality Assessment Program (NAWQA) website. PENDIMETHALIN - herbicide 2002 estimated annual agricultural use Average annual use of active ingredient (pounds par square mile of agricultural land in county) O no estimated use D 0.001 to 0.113 D 0.114 to 0.746 D 0.747 to 2.459 D 2.46 to 5.677 • >= 5.678 Crops soybeans cotton corn sugarcane peanuts rice sunflower seed potatoes tobacco dry onions Total pounds applied 5128074 2619139 2510653 819146 426157 245003 230464 227553 162376 111265 Percent national use 39.59 20.22 19.38 6.32 3.29 1.89 1.78 1.76 1.25 0.86 http://water.usgs. gov/nawqa/pnsp/usage/maps/show_map.php?year=02&map=ml629 Figure 2.1 Pendimethalin Use in Total Pounds per County Analysis of labeled use information is the critical first step in evaluating the federal action. The current label for pendimethalin represents the FIFRA regulatory action; therefore, labeled use and application rates specified on the label form the basis of this assessment. The assessment of use information is critical to the development of the action area and selection of appropriate modeling scenarios and inputs. The Agency's Biological and Economic Analysis Division (BEAD) provides an analysis of both national- and county-level usage information (Kaul and Jones, 2006) using state- 24 ------- level usage data obtained from USDA-NASS1, Doane (www.doane.com: the full dataset is not provided due to its proprietary nature) and the California's Department of Pesticide Regulation Pesticide Use Reporting (CDPR PUR) database2. CDPR PUR is considered a more comprehensive source of usage data than USDA-NASS or EPA proprietary databases, and thus the usage data reported for pendimethalin by county in this California-specific assessment were generated using CDPR PUR data. Eight years (1999-2006) of usage data were included in this analysis. Data from CDPR PUR were obtained for every pesticide application made on every use site at the section level (approximately one square mile) of the public land survey system. BEAD summarized these data to the county level by site, pesticide, and unit treated. Calculating county-level usage involved summarizing across all applications made within a section and then across all sections within a county for each use site and for each pesticide. The county level usage data that were calculated include: average annual pounds applied, average annual area treated, and average and maximum application rate across all five years. The units of area treated are also provided where available. Some uses reported in the CDPR PUR database may be different than those considered in the assessment. The uses considered in this risk assessment represent all currently registered uses according to a review of all current labels. No other uses are relevant to this assessment. Any other reported use, such as may be seen in the CDPR PUR database, represent either historic uses that have been canceled, mis-reported uses, or mis-use. Historical uses, mis-reported uses, and misuse are not considered part of the federal action and, therefore, are not considered in this assessment. Table 2.3 below gives the total number of pounds of pendimethalin used in California counties from 1994 to 1998 and 1999 to 2006. The figures represent the sum of the average number of pounds used in each year of the two periods, as reported in the Pesticide use Reporting database (PUR). Summaries of the data were provided by OPP's Biological and Economic Analysis Division (BEAD). The data indicate that the largest amounts were used in Kings, Fresno, and Kern counties, all of which exceeded 150,000 pounds. Thirteen counties (Santa Barbara through Glenn) showed use of between 10,000 and 100,000 pounds during the period. Twenty-two counties (Contra Costa through El Dorado) had usage of between 1,000 and 10,000 pounds. Overall, 54 of 58 California counties had reported usage of pendimethalin, indicating that use of the compound is geographically widespread. This is a strong line of evidence that the CRLF is potentially exposed to pendimethalin. 1 United States Depart of Agriculture (USDA), National Agricultural Statistics Service (NASS) Chemical Use Reports provide summary pesticide usage statistics for select agricultural use sites by chemical, crop and state. See http://www.usda.gov/nass/pubs/estindxl.htm#agchem. 2 The California Department of Pesticide Regulation's Pesticide Use Reporting database provides a census of pesticide applications in the state. See http://www.cdpr.ca.gov/docs/pur/purmain.htm. 25 ------- Table 2-3 Summary of California Department of Pesticide Registration (CDPR) Pesticide Use Reporting (PUR) Data from 1994 to 2006 for Currently Registered Pendimethalin Uses: By County County KINGS FRESNO KERN SANTA BARBARA TULARE LOS ANGELES IMPERIAL STANISLAUS RIVERSIDE MERCED SAN JOAQUIN MADERA BUTTE SANTA CLARA GLENN CONTRA COSTA ORANGE SACRAMENTO SAN DIEGO SOLANO SONOMA ALAMEDA YOLO PLACER SAN BERNARDINO MONTEREY COLUSA SAN LUIS OBISPO SUTTER TEHAMA YUBA SAN MATEO VENTURA SAN BENITO CALAVERAS SHASTA EL DORADO NAPA LAKE MARIN TUOLUMNE LAS SEN MODOC 1994- 1998 99690 74212 90122 820 16738 4671 15584 9128 15279 10480 6801 7660 5758 5717 4865 3222 5272 5571 6588 2211 2897 1810 1322 1309 2339 2328 1149 1761 1109 1148 371 798 824 809 609 593 466 418 367 563 239 169 84 1999- 2006 95429 77816 59505 83486 33549 41639 24149 24623 14997 9747 11203 10086 5974 5838 6202 6083 3634 3030 1854 4261 3546 3288 3640 3167 2073 2052 2985 1610 1857 1212 1368 854 809 753 665 642 611 411 261 46 361 309 389 Total 195119 152028 149627 84306 50287 46310 39733 33751 30276 20227 18004 17746 11732 11555 11067 9305 8906 8601 8442 6472 6443 5098 4962 4476 4412 4380 4134 3371 2966 2360 1739 1652 1633 1562 1274 1235 1077 829 628 609 600 478 473 26 ------- MENDOCINO AMADOR SISKIYOU NEVADA SANTA CRUZ SAN FRANCISCO MONO HUMBOLDT INYO MARIPOSA TRINITY 158 272 138 307 148 85 149 53 49 24 0 293 145 250 74 131 116 39 19 11 4 1 451 417 388 381 279 201 188 72 60 28 1 Table 2.3b below shows the number of pounds of pendimethalin applied by crop and use site, during the periods 1994 to 1998, and 1999 to 2006. The figures are aggregated across counties, and are ranked by total numbers of pounds applied in the entire period. Only crops or use sites with at least 1,000 pounds usage are shown in the table. Cotton is the major use, with nearly two million pounds applied from 1994 to 2006. Six use sites (landscape, almond, rights-of-way, garlic, onions, pistachio, and alfalfa) each totaled over 100,000 pounds applied. A further 18 uses (nursery through nectarine) each had from 10,000 to 100,000 pounds of usage. It is notable that non-agricultural uses (landscape and rights-of-way) are among the highest uses of pendimethalin. Based on the county rankings, it is concluded that these uses represent the greatest part of the usage in urban counties. Table 2.3b. Summary of California Department of Pesticide Registration (CDPR) Pesticide Use Reporting (PUR) Data from 1994 to 2006 for Currently Registered Pendimethalin Uses: By Crop/Use Site CROP/USE SITE COTTON LANDSCAPE MAINTENANCE ALMOND RIGHTS OF WAY GARLIC ONION, DRY & GREEN PISTACHIO ALFALFA NURSERY - ALL GRAPE, WINE POTATO GRAPE CORN, HUMAN CONSUMPTION BEAN, DRIED UNCULTIVATED AG / nonag WALNUT 1994-1998 Ibs 1198354 213421 124150 40510 100657 49023 28480 3327 43897 39711 41086 34005 29757 14529 8370 17340 1999-2006 Ibs 787909 224903 88858 146505 70532 93909 93363 99865 44167 45880 35707 25160 28782 38200 42817 29352 TOTAL Ibs 1986263 438324 213008 187015 171189 142932 121843 103192 88064 85591 76793 59165 58539 52729 51187 46692 27 ------- CORN (FORAGE - FODDER) SUNFLOWER ORANGE PEACH RICE BEAN, UNSPECIFIED SOIL FUMIGATION/PREPLANT PRUNE BEAN, SUCCULENT NECTARINE WHEAT PLUM CHERRY SAFFLOWER STRUCTURAL PEST CONTROL TOMATO CELERY LEMON APPLE TURF/SOD WATER(INDUSTRIAL) SUGARCANE TANGERINE SORGHUM/MILO 13629 8257 2317 3572 1237 11229 6852 12351 2817 2529 7703 594 0 180 2204 796 3354 817 2369 1624 0 72 174 892 22894 12354 17988 13534 15149 4922 8718 3213 7853 8053 1143 6954 6913 3853 1685 2863 15 2288 594 1013 1429 1307 1178 281 36523 20611 20305 17106 16386 16151 15570 15564 10670 10582 8846 7548 6913 4033 3889 3659 3369 3105 2963 2637 1429 1379 1352 1173 2.5 Assessed Species The CRLF was federally listed as a threatened species by USFWS effective June 24, 1996 (USFWS 1996). It is one of two subspecies of the red-legged frog and is the largest native frog in the western United States (USFWS 2002). A brief summary of information regarding CRLF distribution, reproduction, diet, and habitat requirements is provided in Sections 2.5.1 through 2.5.4, respectively. Further information on the status, distribution, and life history of and specific threats to the CRLF is provided in Attachment 1. Final critical habitat for the CRLF was designated by USFWS on April 13, 2006 (USFWS 2006; 71 FR 19244-19346). Further information on designated critical habitat for the CRLF is provided in Section 2.6. 2.5.1 Distribution The CRLF is endemic to California and Baja California (Mexico) and historically inhabited 46 counties in California including the Central Valley and both coastal and interior mountain ranges (USFWS 1996). Its range has been reduced by about 70%, and the species currently resides in 22 counties in California (USFWS 1996). The species has an elevational range of near sea level to 1,500 meters (5,200 feet) (Jennings and Hayes 1994); however, nearly all of the known CRLF populations have been documented below 1,050 meters (3,500 feet) (USFWS 2002). 28 ------- Populations currently exist along the northern California coast, northern Transverse Ranges (USFWS 2002), foothills of the Sierra Nevada (5-6 populations), and in southern California south of Santa Barbara (two populations) (Fellers 2005a). Relatively larger numbers of CRLFs are located between Marin and Santa Barbara Counties (Jennings and Hayes 1994). A total of 243 streams or drainages are believed to be currently occupied by the species, with the greatest numbers in Monterey, San Luis Obispo, and Santa Barbara counties (USFWS 1996). Occupied drainages or watersheds include all bodies of water that support CRLFs (i.e., streams, creeks, tributaries, associated natural and artificial ponds, and adjacent drainages), and habitats through which CRLFs can move (i.e., riparian vegetation, uplands) (USFWS 2002). The distribution of CRLFs within California is addressed in this assessment using four categories of location including recovery units, core areas, designated critical habitat, and known occurrences of the CRLF reported in the California Natural Diversity Database (CNDDB) that are not included within core areas and/or designated critical habitat (see Figure 2.2). Recovery units, core areas, and other known occurrences of the CRLF from the CNDDB are described in further detail in Attachment I, and designated critical habitat is addressed in Section 2.6. Recovery units are large areas defined at the watershed level that have similar conservation needs and management strategies. The recovery unit is primarily an administrative designation, and land area within the recovery unit boundary is not exclusively CRLF habitat. Core areas are smaller areas within the recovery units that comprise portions of the species' historic and current range and have been determined by USFWS to be important in the preservation of the species. Designated critical habitat is generally contained within the core areas, although a number of critical habitat units are outside the boundaries of core areas, but within the boundaries of the recovery units. Additional information on CRLF occurrences from the CNDDB is used to cover the current range of the species not included in core areas and/or designated critical habitat, but within the recovery units. Other Known Occurrences from the CNDBB The CNDDB provides location and natural history information on species found in California. The CNDDB serves as a repository for historical and current species location sightings. Information regarding known occurrences of CRLFs outside of the currently occupied core areas and designated critical habitat is considered in defining the current range of the CRLF. See: http://www.dfg.ca.gov/bdb/html/cnddb_info.html for additional information on the CNDDB. 29 ------- Recovery Units 1. Sierra Nevada Foothills and Central Valley 2. North Coast Range Foothills nd Western Sacramento River Valley 3. North Coast and North San Francisco Bay 4. South and East San Francisc Bay 5. Central Coast 6. Diablo Range and Salinas Valley 7. Northern Transverse Rang nd Tehachapi Mountains 8. Southern Transverse and Peninsular Ranges Legend ] Recovery Unit Boundaries |] Currently Occupied Core Areas ^B Critical Habitat I CNDDB Occurence Sections _! County Boundaries 45 Core Areas 1. Feather River Yuba River- S. Fork Feather River Traverse Creek/ Middle Fork/ American R. Rubicon Cosumnes River South Fork Calaveras River* Tuolumne River* Piney Creek* Cottonwood Creek Putah Creek - Cache Creek* 9. 10. Lake Berryessa Tributaries 11. Upper Sonoma Creek 12. Petaluma Creek — Sonoma Creek 13. R. Reyes Peninsula 14. Belvedere Lagoon 15. Jameson Canyon - Lower Napa River 16. East San Francisco Bay 17. Santa Clara Valley 18. South San Francisco Bay * Core areas that were historically occupied by the California red-legged frog are not included in the map 19. Watsonville Slough-Elkhorn Slough 20. Carmel River — Santa Lucia 21. Gab Ian Range 22. Estero Bay 23. Arroyo Grange River 24. Santa Maria River - Santa Ynez River 25. Sisquoc River 26. Ventura River - Santa Clara River 27. Santa Monica Bay - Venura Coastal Streams 28. Estrella River 29. San Gabriel Mountain* 30. Forks of the Mojave* 31. Santa Ana Mountain* 32. Santa Rosa Plateau 33. San Luis Ray* Sweetwater* Laguna Mountain* Figure 2.2 Recovery Unit, Core Area, Critical Habitat, and Occurrence Designations for CRLF 30 ------- 2.5.2 Reproduction CRLFs breed primarily in ponds; however, they may also breed in quiescent streams, marshes, and lagoons (Fellers 2005a). According to the Recovery Plan (USFWS 2002), CRLFs breed from November through late April. Peaks in spawning activity vary geographically; Fellers (2005b) reports peak spawning as early as January in parts of coastal central California. Eggs are fertilized as they are being laid. Egg masses are typically attached to emergent vegetation, such as bulrushes (Scirpus spp.) and cattails (Typha spp.) or roots and twigs, and float on or near the surface of the water (Hayes and Miyamoto 1984). Egg masses contain approximately 2000 to 6000 eggs ranging in size between 2 and 2.8 mm (Jennings and Hayes 1994). Embryos hatch 10 to 14 days after fertilization (Fellers 2005a) depending on water temperature. Egg predation is reported to be infrequent and most mortality is associated with the larval stage (particularly through predation by fish); however, predation on eggs by newts has also been reported (Rathburn 1998). Tadpoles require 11 to 28 weeks to metamorphose into juveniles (terrestrial-phase), typically between May and September (Jennings and Hayes 1994, USFWS 2002); tadpoles have been observed to over-winter (delay metamorphosis until the following year) (Fellers 2005b, USFWS 2002). Males reach sexual maturity at 2 years, and females reach sexual maturity at 3 years of age; adults have been reported to live 8 to 10 years (USFWS 2002). Figure 2.3 depicts CRLF annual reproductive timing. J F M A M J J A S o N D Light Blue = Breeding/Egg Masses Green = Tadpoles (except those that over-winter) Orange = Adults and juveniles can be present all year Figure 2.3 CRLF Reproductive Events by Month 2.5.3 Diet Although the diet of CRLF aquatic-phase larvae (tadpoles) has not been studied specifically, it is assumed that their diet is similar to that of other frog species, with the aquatic phase feeding exclusively in water and consuming diatoms, algae, and detritus (USFWS 2002). Tadpoles filter and entrap suspended algae (Seale and Beckvar, 1980) via mouthparts designed for effective grazing of periphyton (Wassersug, 1984, Kupferberg et al; 1994; Kupferberg, 1997; Altig and McDiarmid, 1999). Juvenile and adult CRLFs forage in aquatic and terrestrial habitats, and their diet differs greatly from that of larvae. The main food source for juvenile aquatic- and terrestrial- phase CRLFs is thought to be aquatic and terrestrial invertebrates found along the shoreline and on the water surface. Hayes and Tennant (1985) report, based on a study examining the gut content of 35 juvenile and adult CRLFs, that the species feeds on as many as 42 different invertebrate taxa, including Arachnida, Amphipoda, Isopoda, Insecta, and Mollusca. The most commonly observed prey species were larval alderflies ------- (Stalls cf. californicd)., pillbugs (Armadilliadrium vulgare), and water striders (Gerris sp). The preferred prey species, however, was the sowbug (Hayes and Tennant, 1985). This study suggests that CRLFs forage primarily above water, although the authors note other data reporting that adults also feed under water, are cannibalistic, and consume fish. For larger CRLFs, over 50% of the prey mass may consists of vertebrates such as mice, frogs, and fish, although aquatic and terrestrial invertebrates were the most numerous food items (Hayes and Tennant 1985). For adults, feeding activity takes place primarily at night; for juveniles feeding occurs during the day and at night (Hayes and Tennant 1985). 2.5.4 Habitat CRLFs require aquatic habitat for breeding, but also use other habitat types including riparian and upland areas throughout their life cycle. CRLF use of their environment varies; they may complete their entire life cycle in a particular habitat or they may utilize multiple habitat types. Overall, populations are most likely to exist where multiple breeding areas are embedded within varying habitats used for dispersal (USFWS 2002). Generally, CRLFs utilize habitat with perennial or near-perennial water (Jennings et al. 1997). Dense vegetation close to water, shading, and water of moderate depth are habitat features that appear especially important for CRLF (Hayes and Jennings 1988). Breeding sites include streams, deep pools, backwaters within streams and creeks, ponds, marshes, sag ponds (land depressions between fault zones that have filled with water), dune ponds, and lagoons. Breeding adults have been found near deep (0.7 m) still or slow moving water surrounded by dense vegetation (USFWS 2002); however, the largest number of tadpoles have been found in shallower pools (0.26 - 0.5 m) (Reis, 1999). Data indicate that CRLFs do not frequently inhabit vernal pools, as conditions in these habitats generally are not suitable (Hayes and Jennings 1988). CRLFs also frequently breed in artificial impoundments such as stock ponds, although additional research is needed to identify habitat requirements within artificial ponds (USFWS 2002). Adult CRLFs use dense, shrubby, or emergent vegetation closely associated with deep-water pools bordered with cattails and dense stands of overhanging vegetation (http://www.fws.gov/endangered/features/rl_frog/rlfrog.html#where). In general, dispersal and habitat use depends on climatic conditions, habitat suitability, and life stage. Adults rely on riparian vegetation for resting, feeding, and dispersal. The foraging quality of the riparian habitat depends on moisture, composition of the plant community, and presence of pools and backwater aquatic areas for breeding. CRLFs can be found living within streams at distances up to 3 km (2 miles) from their breeding site and have been found up to 30 m (100 feet) from water in dense riparian vegetation for up to 77 days (USFWS 2002). During dry periods, the CRLF is rarely found far from water, although it will sometimes disperse from its breeding habitat to forage and seek other suitable habitat under downed trees or logs, industrial debris, and agricultural features (UWFWS 2002). According to Jennings and Hayes (1994), CRLFs also use small mammal burrows and moist leaf litter as habitat. In addition, CRLFs may also use large cracks in the bottom of dried ponds as 32 ------- refugia; these cracks may provide moisture for individuals avoiding predation and solar exposure (Alvarez 2000). 2.6 Designated Critical Habitat In a final rule published on April 13, 2006, 34 separate units of critical habitat were designated for the CRLF by USFWS (USFWS 2006; FR 51 19244-19346). A summary of the 34 critical habitat units relative to USFWS-designated recovery units and core areas (previously discussed in Section 2.5.1) is provided in Attachment I. 'Critical habitat' is defined in the ESA as the geographic area occupied by the species at the time of the listing where the physical and biological features necessary for the conservation of the species exist, and there is a need for special management to protect the listed species. It may also include areas outside the occupied area at the time of listing if such areas are 'essential to the conservation of the species.' All designated critical habitat for the CRLF was occupied at the time of listing. Critical habitat receives protection under Section 7 of the ESA (Section 7) through prohibition against destruction or adverse modification with regard to actions carried out, funded, or authorized by a federal Agency. Section 7 requires consultation on federal actions that are likely to result in the destruction or adverse modification of critical habitat. To be included in a critical habitat designation, the habitat must be 'essential to the conservation of the species.' Critical habitat designations identify, to the extent known using the best scientific and commercial data available, habitat areas that provide essential life cycle needs of the species or areas that contain certain primary constituent elements (PCEs) (as defined in 50 CFR 414.12(b)). PCEs include, but are not limited to, space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, rearing (or development) of offspring; and habitats that are protected from disturbance or are representative of the historic geographical and ecological distributions of a species. The designated critical habitat areas for the CRLF are considered to have the following PCEs that justify critical habitat designation: • Breeding aquatic habitat; • Non-breeding aquatic habitat; • Upland habitat; and • Dispersal habitat. Further description of these habitat types is provided in Attachment I. Occupied habitat may be included in the critical habitat only if essential features within the habitat may require special management or protection. Therefore, USFWS does not include areas where existing management is sufficient to conserve the species. Critical habitat is designated outside the geographic area presently occupied by the species only when a designation limited to its present range would be inadequate to ensure the conservation of the species. For the CRLF, all designated critical habitat units contain all 33 ------- four of the PCEs, and were occupied by the CRLF at the time of FR listing notice in April 2006. The FR notice designating critical habitat for the CRLF includes a special rule exempting routine ranching activities associated with livestock ranching from incidental take prohibitions. The purpose of this exemption is to promote the conservation of rangelands, which could be beneficial to the CRLF, and to reduce the rate of conversion to other land uses that are incompatible with CRLF conservation. Please see Attachment I for a full explanation on this special rule. USFWS has established adverse modification standards for designated critical habitat (USFWS 2006). Activities that may destroy or adversely modify critical habitat are those that alter the PCEs and jeopardize the continued existence of the species. Evaluation of actions related to use of pendimethalin that may alter the PCEs of the CRLF's critical habitat form the basis of the critical habitat impact analysis. According to USFWS (2006), activities that may affect critical habitat and therefore result in adverse effects to the CRLF include, but are not limited to the following: (1) Significant alteration of water chemistry or temperature to levels beyond the tolerances of the CRLF that result in direct or cumulative adverse effects to individuals and their life-cycles. (2) Alteration of chemical characteristics necessary for normal growth and viability of juvenile and adult CRLFs. (3) Significant increase in sediment deposition within the stream channel or pond or disturbance of upland foraging and dispersal habitat that could result in elimination or reduction of habitat necessary for the growth and reproduction of the CRLF by increasing the sediment deposition to levels that would adversely affect their ability to complete their life cycles. (4) Significant alteration of channel/pond morphology or geometry that may lead to changes to the hydrologic functioning of the stream or pond and alter the timing, duration, water flows, and levels that would degrade or eliminate the CRLF and/or its habitat. Such an effect could also lead to increased sedimentation and degradation in water quality to levels that are beyond the CRLF's tolerances. (5) Elimination of upland foraging and/or aestivating habitat or dispersal habitat. (6) Introduction, spread, or augmentation of non-native aquatic species in stream segments or ponds used by the CRLF. (7) Alteration or elimination of the CRLF's food sources or prey base (also evaluated as indirect effects to the CRLF). As previously noted in Section 2.1, the Agency believes that the analysis of direct and indirect effects to listed species provides the basis for an analysis of potential effects on the designated critical habitat. Because pendimethalin is expected to directly impact living organisms within the action area, critical habitat analysis for pendimethalin is limited in a practical sense to those PCEs of critical habitat that are biological or that can be reasonably linked to biologically mediated processes. 34 ------- 2.7 Action Area For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by the federal action and not merely the immediate area involved in the action (50 CFR 402.02). It is recognized that the overall action area for the national registration of pendimethalin is likely to encompass considerable portions of the United States based on the large array of agricultural and its non-agricultural uses. However, the scope of this assessment limits consideration of the overall action area to those portions that may be applicable to the protection of the CRLF and its designated critical habitat within the state of California. The Agency's approach to defining the action area under the provisions of the Overview Document (USEPA 2004) considers the results of the risk assessment process to establish boundaries for that action area with the understanding that exposures below the Agency's defined Levels of Concern (LOCs) constitute a no-effect threshold. For the purposes of this assessment, attention will be focused on the footprint of the action (i.e., the area where pesticide application occurs), plus all areas where offsite transport (i.e., spray drift, downstream dilution, etc.) may result in potential exposure within the state of California that exceeds the Agency's LOCs. Deriving the geographical extent of this portion of the action area is based on consideration of the types of effects that pendimethalin may be expected to have on the environment, the exposure levels to pendimethalin that are associated with those effects, and the best available information concerning the use of pendimethalin and its fate and transport within the state of California. Specific measures of ecological effect that define the action area include any direct and indirect toxic effect and any potential modification of its critical habitat, including reduction in survival, growth, and fecundity as well as the full suite of sublethal effects available in the effects literature. Therefore, 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 determine the threshold for an observed effect, the action area is not spatially limited and is assumed to be the entire state of California. The definition of action area requires a stepwise approach that begins with an understanding of the federal action. The federal action is defined by the currently labeled uses for pendimethalin. An analysis of labeled uses and review of available product labels was completed. Several of the current labels are special local needs (SLN) labels for other states and some uses on other labels are restricted to specific states other than California and are, therefore, excluded from this assessment. The agricultural and nonagricultural uses that are considered as part of the federal action evaluated in this assessment can be found in Table 2.2. Following a determination of the assessed uses, an evaluation of the potential "footprint" of pendimethalin use patterns (i.e., the area where pesticide application occurs) is determined. This "footprint" represents the initial area of concern, based on an analysis of available land cover data for the state of California. The initial area of concern is defined as all land cover types and the stream reaches within the land cover areas that 35 ------- represent the labeled uses described above. A map representing all the land cover types that make up the initial area of concern for pendimethalin is presented in Pendimethalin Use - Initial Area of Concern Forest use Turf use Developed-open space Developed- low density Developed-medium density Developed-high density Pasturehay use Orchard vineyard use Cultivated crop use County boundaries iKilorneters 0 2040 80 120 160 Compiled from California County boundaries(ESRI, 2002), USDA Cap Analysis Program Orchard/Vineyard Landcover (CAP) National Land Cover Database (NLCD) (MRLC. 2001) Map created by US Environmental Protection Agency, Office of Pesticides Programs, Environmental Fate and Effects Dwision. Projection: A Ibers Equal Area Conic USGS, North American Datum of 1983 (NAD 1983). Wlv ;-t- -' -•- 5/26/2009 Figure 2.4. More information regarding which specific uses are represented for each land cover types can be found in Appendix D. 36 ------- Pendimethalin Use - Initial Area of Concern | Forest use | Turf use Developed-open space Developed-low density Developed-medium density Developed-high density Pasturehay use Orchard vineyard use Cultivated crop use County boundaries iKilorneters 0 2040 80 120 160 Compiled from California County boundaries(ESRI, 2002), USDA Gap Analysis Program Orchard/Vineyard Landcover (GAP) National Land Cover Database (NLCD) (MRLC, 2001) Map created by US Environmental Protection Agency, Office of P e st ic id es P rocj rams, E nv i ro nrnental F ate an d Effe ct s Dw i sio n. Projection: Alb ers Equal Area Conic USGS, North American Datum of 1983 (NAD 1983). 5/26/2009 Figure 2.4. Initial area of concern, or "footprint" of potential use, for Pendimethalin 37 ------- Once the initial area of concern is defined, the next step is to define the potential boundaries of the action area by determining the extent of offsite transport via spray drift and runoff where exposure of one or more taxonomic groups to the pesticide exceeds the listed species LOCs. As previously discussed, the action area is defined by the most sensitive measure of direct and indirect ecological toxic effects including reduction in survival, growth, reproduction, and the entire suite of sublethal effects from valid, peer-reviewed studies. The action area is determined by the footprint of the action plus all offsite areas where exposure of one or more taxonomic groups to pendimethalin exceeds the Agency's LOCs. The spatial extent at which the Agency's LOCs are not exceeded is based on the potential exposure level and the most sensitive effects endpoints The most sensitive for terrestrial environments was the plant EC25 of 0.01 Ib/acre for ryegrass seedling emergence, Table 4.5). The most sensitive endpoints for aquatic environments were the duckweed EC50 of 12.5 ppb and the diatom EC50 of 5.2 ppb (section 4.1.3.1). The routes of exposure that determine the extent of the action area are run-off in stormwater or irrigation water (mostly in the sorbed phase) and spray drift. Volatilization and redeposition (eg., via rainwater) may also contribute to the extent of the action area, bur this could not be quantified. A paper by Vogel et al. (2008) found pendimethalin in rainwater in Merced County at a concentration of 0.143 ppb maximum. This is an additional line of evidence that pendimethalin may be transported by air outside the immediate use site. The AgDRIFT model (Version 2.01) is used to define how far from the initial area of concern an effect to a given species may be expected via spray drift. The spray drift analysis for pendimethalin using the most sensitive endpoint (ryegrass seedling emergence EC25 of 0.01 Ib/acre) suggests that effects are expected beyond 1,000 feet from the edge of pendimethalin treated areas In addition to the buffered area from the spray drift analysis, the final action area also considers the downstream extent of pendimethalin that exceeds the LOG. Based on this analysis, the action area includes streams as far as 272 kilometers downstream from forestry use areas. An evaluation of usage information was conducted to determine the area where use of pendimethalin may impact the CRLF. This analysis is used to characterize where predicted exposures are most likely to occur, but does not preclude use in other portions of the action area. A more detailed review of the county-level use information was also completed. These data suggest that pendimethalin is widely used both in agricultural and non-agricultural settings in 54 of 58 California counties. Thus, it is likely that pendimethalin use sites and CRLF habitat areas intersect. 38 ------- Based on these considerations, the action area is considered to be the entire state of California. 2.8 Assessment Endpoints and Measures of Ecological Effect Assessment endpoints are defined as "explicit expressions of the actual environmental value that is to be protected."3 Selection of the assessment endpoints is based on valued entities (e.g., CRLF, organisms important in the life cycle of the CRLF, and the PCEs of its designated critical habitat), the ecosystems potentially at risk (e.g., waterbodies, riparian vegetation, and upland and dispersal habitats), the migration pathways of pendimethalin (e.g., runoff, spray drift, etc.), and the routes by which ecological receptors are exposed to pendimethalin (e.g., direct contact, etc.). 2.8.1 Assessment Endpoints for the CRLF Assessment endpoints for the CRLF include direct toxic effects on the survival, reproduction, and growth of the CRLF, as well as indirect effects, such as reduction of the prey base or modification of its habitat. In addition, potential modification of critical habitat is assessed by evaluating potential effects to PCEs, which are components of the habitat areas that provide essential life cycle needs of the CRLF. 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. Specific measures of ecological effect are generally evaluated based on acute and chronic toxicity information from registrant-submitted guideline tests that are performed on a limited number of organisms. Additional ecological effects data from the open literature are also considered. It should be noted that assessment endpoints are limited to direct and indirect effects associated with survival, growth, and fecundity, and do not include the full suite of sublethal effects used to define the action area. According the Overview Document (USEPA 2004), the Agency relies on acute and chronic effects endpoints that are either direct measures of impairment of survival, growth, or fecundity or endpoints for which there is a scientifically robust, peer reviewed relationship that can quantify the impact of the measured effect endpoint on the assessment endpoints of survival, growth, and fecundity. A complete discussion of all the toxicity data available for this risk assessment, including resulting measures of ecological effect selected for each taxonomic group of concern, is included in Section 4.0 of this document. A summary of the assessment endpoints and measures of ecological effect selected to characterize potential assessed direct and indirect CRLF risks associated with exposure to pendimethalin is provided in table 2-4 below. 3 U.S. EPA (1992). Framework for Ecological Risk Assessment. EPA/630/R-92/001. 39 ------- Table 2-4 Assessment Endpoints and Measures of Ecological Effects Assessment Endpoint Measures of Ecological Effects4 Aquatic-Phase CRLF (Eggs, larvae, juveniles, andadultsf Direct Effects 1. Survival, growth, and reproduction of CRLF la. Most sensitive fish acute LC50 (guideline or ECOTOX) if no suitable amphibian data are available Ib. Most sensitive fish chronic NOAEC (guideline or ECOTOX) if no suitable amphibian data are available Indirect Effects and Critical Habitat Effects 1. Survival, growth, and reproduction of CRLF individuals via indirect effects on aquatic prey food supply (i.e., fish, freshwater invertebrates, non- vascular plants) 3. Survival, growth, and reproduction of CRLF individuals via indirect effects on habitat, cover, food supply, and/or primary productivity (i.e., aquatic plant community) 4. Survival, growth, and reproduction of CRLF individuals via effects to riparian vegetation 2a. Most sensitive fish, aquatic invertebrate, and aquatic plant EC50 or LC50 (guideline or ECOTOX) 2b. Most sensitive aquatic invertebrate and fish chronic NOAEC (guideline or ECOTOX) 3 a. Vascular plant acute EC50 (duckweed guideline test or ECOTOX vascular plant) 3b. Non-vascular plant acute EC50 (freshwater algae or diatom, or ECOTOX non-vascular) 4a. Distribution of EC25 values for monocots (seedling emergence, vegetative vigor, or ECOTOX) 4b. Distribution of EC25 values for dicots (seedling emergence, vegetative vigor, or ECOTOX) Terrestrial-Phase CRLF (Juveniles and adults) Direct Effects 5. Survival, growth, and reproduction of CRLF individuals via direct effects on terrestrial phase adults and juveniles 5a. Most sensitive birdb or terrestrial-phase amphibian acute LC50 or LD50 (guideline or ECOTOX) 5b. Most sensitive birdb or terrestrial-phase amphibian chronic NOAEC (guideline or ECOTOX) Indirect Effects and Critical Habitat Effects 6. Survival, growth, and reproduction of CRLF individuals via effects on terrestrial prey (i.e., terrestrial invertebrates, small mammals , and frogs) 7. Survival, growth, and reproduction of CRLF individuals via indirect effects on habitat (i.e., riparian and upland vegetation) 6a. Most sensitive terrestrial invertebrate and vertebrate acute EC50 or LC50 (guideline or ECOTOX)C 6b. Most sensitive terrestrial invertebrate and vertebrate chronic NOAEC (guideline or ECOTOX) 7a. Distribution of EC25 for monocots (seedling emergence, vegetative vigor, or ECOTOX 7b. Distribution of EC25 for dicots (seedling emergence, vegetative vigor, or ECOTOX) a Adult frogs are no longer in the "aquatic phase" of the amphibian life cycle; however, submerged adult frogs are considered "aquatic" for the purposes of this assessment because exposure pathways in the water are considerably different that exposure pathways on land. b Birds are used as surrogates for terrestrial phase amphibians. 4 All registrant-submitted and open literature toxicity data reviewed for this assessment are included in Appendix A. 40 ------- 2.8.2 Assessment Endpoints for Designated Critical Habitat As previously discussed, designated critical habitat is assessed to evaluate actions related to the use of pendimethalin that may alter the PCEs of the CRLF's critical habitat. PCEs for the CRLF were previously described in Section 2.6. Actions that may modify critical habitat are those that alter the PCEs and jeopardize the continued existence of the CRLF. Therefore, these actions are identified as assessment endpoints. It should be noted that evaluation of PCEs as assessment endpoints is limited to those of a biological nature (i.e., the biological resource requirements for the listed species associated with the critical habitat) and those for which pendimethalin effects data are available. Adverse modification to the critical habitat of the CRLF includes, but is not limited to, those listed in Section 2.6. Measures of such possible effects by labeled use of pendimethalin on critical habitat of the CRLF are described in Table 2-55. Some components of these PCEs are associated with physical abiotic features (e.g., presence and/or depth of a water body, or distance between two sites), which are not expected to be measurably altered by use of pesticides. Assessment endpoints used for the analysis of designated critical habitat are based on the adverse modification standard established by USFWS (2006). 41 ------- Table 2-5 Summary of Assessment Endpoints and Measures of Ecological Effect for Primary Constituent Elements of Designated Critical Habitat3 Assessment Endpoint Measures of Ecological Effect Aquatic-Phase CRLFPCEs (Aquatic Breeding Habitat and Aquatic Non-Breeding Habitat) Alteration of channel/pond morphology or geometry and/or increase in sediment deposition within the stream channel or pond: aquatic habitat (including riparian vegetation) provides for shelter, foraging, predator avoidance, and aquatic dispersal for juvenile and adult CRLFs. Alteration in water chemistry /quality including temperature, turbidity, and oxygen content necessary for normal growth and viability of juvenile and adult CRLFs and their food source. Alteration of other chemical characteristics necessary for normal growth and viability of CRLFs and their food source. Reduction and/or modification of aquatic-based food sources for pre-metamorphs (e.g., algae) a. Most sensitive aquatic plant EC50 (guideline or ECOTOX) b. Distribution of EC25 values for terrestrial monocots (seedling emergence, vegetative vigor, or ECOTOX) c. Distribution of EC25 values for terrestrial dicots (seedling emergence, vegetative vigor, or ECOTOX) a. Most sensitive EC50 values for aquatic plants (guideline or ECOTOX) b. Distribution of EC25 values for terrestrial monocots (seedling emergence or vegetative vigor, or ECOTOX) c. Distribution of EC25 values for terrestrial dicots (seedling emergence, vegetative vigor, or ECOTOX) a. Most sensitive EC50 or LC50 values for fish or aquatic- phase amphibians and aquatic invertebrates (guideline or ECOTOX) b. Most sensitive NOAEC values for fish or aquatic -phase amphibians and aquatic invertebrates (guideline or ECOTOX) a. Most sensitive aquatic plant EC50 (guideline or ECOTOX) Terrestrial-Phase CRLFPCEs (Upland Habitat and Dispersal Habitat) Elimination and/or disturbance of upland habitat; ability of habitat to support food source of CRLFs: Upland areas within 200 ft of the edge of the riparian vegetation or dripline surrounding aquatic and riparian habitat that are comprised of grasslands, woodlands, and/or wetland/riparian plant species that provides the CRLF shelter, forage, and predator avoidance Elimination and/or disturbance of dispersal habitat: Upland or riparian dispersal habitat within designated units and between occupied locations within 0.7 mi of each other that allow for movement between sites including both natural and altered sites which do not contain barriers to dispersal Reduction and/or modification of food sources for terrestrial phase juveniles and adults Alteration of chemical characteristics necessary for normal growth and viability of juvenile and adult CRLFs and their food source. a. Distribution of EC25 values for monocots (seedling emergence, vegetative vigor, or ECOTOX) b. Distribution of EC25 values for dicots (seedling emergence, vegetative vigor, or ECOTOX) c. Most sensitive food source acute EC50/LC50 and NOAEC values for terrestrial vertebrates (mammals) and invertebrates, birds or terrestrial-phase amphibians, and freshwater fish. a Physico-chemical water quality parameters such as salinity, pH, and hardness are not evaluated because these processes are not biologically mediated and, therefore, are not relevant to the endpoints included in this assessment. 42 ------- 2.9 Conceptual Model 2.9.1 Risk Hypotheses Risk hypotheses are specific assumptions about potential adverse effects (i.e.,changes in assessment endpoints) and may be based on theory and logic, empirical data, mathematical models, or probability models (U.S. EPA, 1998). For this assessment, the risk is stressor-linked, where the stressor is the release of pendimethalin to the environment. The following risk hypotheses are presumed for this endangered species assessment: The labeled use of pendimethalin within the action area may: • directly affect the CRLF by causing mortality or by adversely affecting growth or fecundity; • indirectly affect the CRLF by reducing or changing the composition of food supply; • indirectly affect the CRLF or modify designated critical habitat by reducing or changing the composition of the aquatic plant community in the ponds and streams comprising the species' current range and designated critical habitat, thus affecting primary productivity and/or cover; • indirectly affect the CRLF or modify designated critical habitat by reducing or changing the composition of the terrestrial plant community (i.e., riparian habitat) required to maintain acceptable water quality and habitat in the ponds and streams comprising the species' current range and designated critical habitat; • affect the designated critical habitat of the CRLF by reducing or changing breeding and non-breeding aquatic habitat (via modification of water quality parameters, habitat morphology, and/or sedimentation); • affect the designated critical habitat of the CRLF by reducing the food supply required for normal growth and viability of juvenile and adult CRLFs; • affect the designated critical habitat of the CRLF by reducing or changing upland habitat within 200 ft of the edge of the riparian vegetation necessary for shelter, foraging, and predator avoidance. • affect the designated critical habitat of the CRLF by reducing or changing dispersal habitat within designated units and between occupied locations within 0.7 mi of each other that allow for movement between sites including both natural and altered sites which do not contain barriers to dispersal. • affect the designated critical habitat of the CRLF by altering chemical characteristics necessary for normal growth and viability of juvenile and adult CRLFs. 2.9.2 Diagram The conceptual model is a graphic representation of the structure of the risk assessment. It specifies the pendimethalin release mechanisms, biological receptor types, and effects endpoints of potential concern. The conceptual models for terrestrial and aquatic exposures are shown in Figure 2.5 and Figure 2.6, respectively, which include the conceptual models for the aquatic and terrestrial PCE components of critical habitat. 43 ------- Exposure routes shown in dashed lines are not quantitatively considered because the contribution of those potential exposure routes to potential risks to the CRLF and modification to designated critical habitat is expected to be negligible. Stressor Source Pendimethalin applied to use site Exposure Media 1—Dermal uptake/lnqestiorr*— .T. Long range atmospheric transport Terrestrial-phase amphibians Terrestrial/riparian plants grasses/forbs, fruit, seeds (trees, shrubs) Root uptake.4! Wet/dry deposition-*1 Ingestion Receptors Ingestion Birds/terrestrial- phase amphibians/ reptiles/mammals Attribute Change Individual organisms Reduced survival Reduced growth Reduced reproduction Food chain Reduction in prey Modification of PCEs related to prey availability Habitat integrity Reduction in primary productivity Reduced cover Community change Modification of PCEs related to habitat Figure 2.5 Conceptual Model for Pesticide Effects on Terrestrial Phase of the CRLF 44 ------- Stressor Pendimethalin applied to use site Source Spray drift and vnlatili7atinn Exposure Media tlll7f || Runoff | :_£: *• Groundwater: Surface water/ Sediment T .T. Long range atmospheric transport .Wet/dry deposition . Receptors Uptake/gills or integument 1 Uptake/gills or integument Aquatic Animals Invertebrates Vertebrates Fish/aquatic-phase amphibians "Piscivorous mammals and birds Inqe^tion Attribute Individual Change organisms Reduced survival Reduced growth Reduced reproduction Uptake/cell, roots^ leaves Aquatic Plants \lon-vascular Vascular t Inqestion Food chain Reduction in algae Reduction in prey Modification of PCEs related to prey availability 1 Habitat integrity Reduction in primary productivity Reduced cover ommunity change Modification of PCEs related to habitat ** Route of exposure includes only ingestion of aquatic fish and invertebrates Figure 2.6 Conceptual Model for Pesticide Effects on Aquatic Phase of the CRLF 2.10 Analysis Plan In order to address the risk hypothesis, the potential for direct and indirect effects to the CRLF, its prey, and its habitat is estimated. In the following sections, the use, environmental fate, and ecological effects of pendimethalin are characterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio of exposure concentration to effects concentration) 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 (U.S. EPA, 2004), the likelihood of effects to individual organisms from particular uses of pendimethalin is estimated using the probit dose-response slope and either the level of concern (discussed below) or actual calculated risk quotient value. 45 ------- 2.10.1 Measures to Evaluate the Risk Hypothesis and Conceptual Model 2.10.1.1 Measures of Exposure The environmental fate properties of pendimethalin along with available monitoring data indicate that runoff and spray drift are the principle potential transport mechanisms of pendimethalin to the aquatic and terrestrial habitats of the CRLF. In this assessment, transport of pendimethalin through runoff and spray drift is considered in deriving quantitative estimates of pendimethalin exposure to CRLF, its prey and its habitats. Measures of exposure are based on aquatic and terrestrial models that predict estimated environmental concentrations (EECs) of pendimethalin using maximum labeled application rates and methods of application. The models used to predict aquatic EECs are the Pesticide Root Zone Model coupled with the Exposure Analysis Model System (PRZM/EXAMS). The Tier 1 Rice model is used to estimate pendimethalin concentrations in rice paddy water on the day of application. The model used to predict terrestrial EECs on food items is T-REX. The model used to derive EECs relevant to terrestrial and wetland plants is TerrPlant. These models are parameterized using relevant reviewed registrant-submitted environmental fate data. PRZM (v3.12.2, May 2005) and EXAMS (v2.98.4.6, April 2005) are screening simulation models coupled with the input shell pe5.pl (Aug 2007) to generate daily exposures and l-in-10 year EECs of pendimethalin that may occur in surface water bodies adjacent to application sites receiving pendimethalin through runoff and spray drift. PRZM simulates pesticide application, movement and transformation on an agricultural field and the resultant pesticide loadings to a receiving water body via runoff, erosion and spray drift. EXAMS simulates the fate of the pesticide and resulting concentrations in the water body. The standard scenario used for ecological pesticide assessments assumes application to a 10-hectare agricultural field that drains into an adjacent 1-hectare water body, 2-meters deep (20,000 m3 volume) with no outlet. PRZM/EXAMS was used to estimate screening-level exposure of aquatic organisms to pendimethalin. The measure of exposure for aquatic species is the l-in-10 year return peak or rolling mean concentration. The l-in-10 year peak is used for estimating acute exposures of direct effects to the CRLF, as well as indirect effects to the CRLF through effects to potential prey items, including: algae, aquatic invertebrates, fish and frogs. The l-in-10-year 60-day mean is used for assessing chronic exposure to the CRLF and fish and frogs serving as prey items; the l-in-10-year 21-day mean is used for assessing chronic exposure for aquatic invertebrates, which are also potential prey items. Exposure in aquatic environments via bioaccumulation and foodchain exposure was quantified with the KABAM (Kow-based bioaccumulation) model (documented at http://www.epa.gov/oppefedl/models/water/kabam/kabam_user_guide.html). Exposure estimates for the terrestrial-phase CRLF and terrestrial invertebrates and mammals (serving as potential prey) assumed to be in the target area or in an area 46 ------- exposed to spray drift are derived using the T-REX model (version 1.3.1, 12/07/2006). This model incorporates the Kenega nomograph, as modified by Fletcher et al. (1994), which is based on a large set of actual field residue data. The upper limit values from the nomograph represented the 95th percentile of residue values from actual field measurements (Hoerger and Kenega, 1972). For modeling purposes, direct exposures of the CRLF to pendimethalin through contaminated food are estimated using the EECs for the small bird (20 g) which consumes small insects. Dietary-based and dose-based exposures of potential prey (small mammals) are assessed using the small mammal (15 g) which consumes short grass. The small bird (20g) consuming small insects and the small mammal (15g) consuming short grass are used because these categories represent the largest RQs of the size and dietary categories in T-REX that are appropriate surrogates for the CRLF and one of its prey items. Estimated exposures of terrestrial insects to pendimethalin are bound by using the dietary based EECs for small insects and large insects. Birds are currently used as surrogates for terrestrial-phase CRLF. However, amphibians are poikilotherms (body temperature varies with environmental temperature) while birds are homeotherms (temperature is regulated, constant, and largely independent of environmental temperatures). Therefore, amphibians tend to have much lower metabolic rates and lower caloric intake requirements than birds or mammals. As a consequence, birds are likely to consume more food than amphibians on a daily dietary intake basis, assuming similar caloric content of the food items. Therefore, the use of avian food intake allometric equation as a surrogate to amphibians is likely to result in an over- estimation of exposure and risk for reptiles and terrestrial-phase amphibians. Therefore, T-REX (version 1.3.1) has been refined to the T-HERPS model (v. 1.0), which allows for an estimation of food intake for poikilotherms using the same basic procedure as T-REX to estimate avian food intake. EECs for terrestrial plants inhabiting dry and wetland areas are derived using TerrPlant (version 1.2.2, 12/26/2006). This model uses estimates of pesticides in runoff and in spray drift to calculate EECs. EECs are based upon solubility and application rate. Spray drift models, AGDISP and/or AgDRIFT are used to assess exposures of terrestrial phase CRLF and its prey to pendimethalin deposited on terrestrial habitats by spray drift. AGDISP (version 8.13; dated 12/14/2004) (Teske and Curbishley, 2003) is used to simulate aerial and ground applications. In addition to the buffered area from the spray drift analysis, the downstream extent of pendimethalin that exceeds the LOG for the effects determination is also considered. Although volatility is a potential route of exposure, volatility and subsequent deposition will not be quantified because there are currently no valid models that would be useful to quantify this potential route of exposure to terrestrial environments. Pendimethalin is a semi-volatile compound that may be lost from moist soil. The volatilization half-life from moist soil was found to be 12.5 days (MRID 00153766). Pendimethalin has been observed at low concentrations (0.143 ppb maximum) in rainwater in California (Vogel et al., 2008). This effect was accounted for in the PRZM-EXAMS modeling by invoking 47 ------- the PRZM volatilization routine, thus allowing volatilization to compete with runoff and metabolism as a dissipation route. Comparison of the highest EEC scenario (forestry) shows that the effect is small (16.6 ppb with volatility invoked and 18.1 ppb without). The relatively slow volatilization rate from even moist soil is not believed to result in as large or immediate an aquatic exposure as spray drift at the time of application. Thus, airborne exposure is adequately quantified by the spray drift analysis. Terrestrial exposure of plants and animals is accounted for by the AgDrift and AgDISP effect area analysis. 2.10.1.2 Measures of Effect Data identified in Section 2.8 are used as measures of effect for direct and indirect effects to the CRLF. Data were obtained from registrant submitted studies or from literature studies identified by ECOTOX. The ECOTOXicology database (ECOTOX) was searched in order to provide more ecological effects data and in an attempt to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX was created and is maintained by the USEPA, Office of Research and Development, and the National Health and Environmental Effects Research Laboratory's Mid-Continent Ecology Division. The assessment of risk for direct effects to the terrestrial-phase CRLF makes the assumption that toxicity of pendimethalin to birds is similar to or less than the toxicity to the terrestrial-phase CRLF. The same assumption is made for fish and aquatic-phase CRLF. Algae, aquatic invertebrates, fish, and amphibians represent potential prey of the CRLF in the aquatic habitat. Terrestrial invertebrates, small mammals, and terrestrial- phase amphibians represent potential prey of the CRLF in the terrestrial habitat. Aquatic, semi-aquatic, and terrestrial plants represent habitat of CRLF. The acute measures of effect used for animals in this screening level assessment are the LD50, LCso and ECso- LD stands for "Lethal Dose", and LD50 is the amount of a material, given all at once, that is estimated to cause the death of 50% of the test organisms. LC stands for "Lethal Concentration" and LCso is the concentration of a chemical that is estimated to kill 50% of the test organisms. EC stands for "Effective Concentration" and the ECso 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-listed animals are the NOAEL/NOAEC and NOEC. NOAEL stands for "No Ob served-Adverse-Effect-Level" and refers to the highest tested dose of a substance that has been reported to have no harmful (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 from the control. The NOEC is the No-Observed-Effects-Concentration. For non-listed plants, only acute exposures are assessed (i.e., EC25 for terrestrial plants and ECso for aquatic plants). It is important to note that the measures of effect for direct and indirect effects to the CRLF and its designated critical habitat are associated with impacts to survival, growth, 48 ------- and fecundity, and do not include the full suite of sublethal effects used to define the action area. According the Overview Document (USEPA 2004), the Agency relies on effects endpoints that are either direct measures of impairment of survival, growth, or fecundity or endpoints for which there is a scientifically robust, peer reviewed relationship that can quantify the impact of the measured effect endpoint on the assessment endpoints of survival, growth, and fecundity. 2.10.1.3 Integration of Exposure and Effects Risk characterization is the integration of exposure and ecological effects characterization to determine the potential ecological risk from agricultural and non-agricultural uses of pendimethalin, and the likelihood of direct and indirect effects to CRLF in aquatic and terrestrial habitats. The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non-target species. For the assessment of pendimethalin risks, the risk quotient (RQ) method is used to compare exposure and measured 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, 2004) (see Appendix C). For this endangered species assessment, listed species LOCs are used for comparing RQ values for acute and chronic exposures of pendimethalin directly to the CRLF. If estimated exposures directly to the CRLF of pendimethalin resulting from a particular use are sufficient to exceed the listed species LOG, then the effects determination for that use is "may affect". When considering indirect effects to the CRLF due to effects to animal prey (aquatic and terrestrial invertebrates, fish, frogs, and mice), the listed species LOCs are also used. If estimated exposures to CRLF prey of pendimethalin resulting from a particular use are sufficient to exceed the listed species LOG, then the effects determination for that use is a "may affect." If the RQ being considered also exceeds the non-listed species acute risk LOG, then the effects determination is a LAA. If the acute RQ is between the listed species LOG and the non-listed acute risk species LOG, then further lines of evidence (i.e. probability of individual effects, species sensitivity distributions) are considered in distinguishing between a determination of NLAA and a LAA. When considering indirect effects to the CRLF due to effects to algae as dietary items or plants as habitat, the non-listed species LOG for plants is used because the CRLF does not have an obligate relationship with any particular aquatic and/or terrestrial plant. If the RQ being considered for a particular use exceeds the non-listed species LOG for plants, the effects determination is "may affect". Further information on LOCs is provided in Appendix C. 3.0 Exposure Assessment Pendimethalin is formulated as granules and emulsifiable concentrate. Application equipment includes ground application, and aerial application. Risks from ground boom 49 ------- and aerial applications are expected to result in the highest off-target levels of pendimethalin due to generally higher spray drift levels. Ground boom and aerial modes of application tend to use lower volumes of application applied in finer sprays than applications coincident with sprayers and spreaders and thus have a higher potential for off-target movement via spray drift. 3.1 Label Application Rates and Intervals Pendimethalin labels may be categorized into two types: labels for manufacturing uses (including technical grade pendimethalin and its formulated products) and end-use products. While technical products, which contain pendimethalin of high purity, are not used directly in the environment, they are used to make formulated products, which can be applied in specific areas to control grasses and certain broadleaf weeds in agricultural crops, orchards, landscapes and rights-of-way. The formulated product labels legally limit pendimethalin's potential use to only those sites that are specified on the labels. There are no known pending mitigations that would influence the exposure assessment. Currently registered agricultural and non-agricultural uses of pendimethalin within California are summarized in Table 3-1. Table 3-1 Pendimethalin Uses, Scenarios, and Application Information for the CRLF risk assessment1 Scenario Scenario CAalfalfa WirrigOP CAalmond WirrigSTD CAalmond WirrigSTD Cacitrus WirrigSTD Cacitrus WirrigSTD CAcolecropRLF CAcornOP Cacotton WirrigSTD CAForestryRLF Cafruit WirrigSTD CAgarlicRLF Cagrapes WirrigSTD Cagrapes WirrigSTD CAmelonsRLF CAOliveRLF CAOnion WirrigSTD CApotatoRLF CArowcropRLF CAStrawberry- noplasticRLF Uses Represented by Scenario Uses Represented alfalfa nut trees nut trees citrus crops citrus crops cole crops field corn, sweet corn, popcorn cotton forestry fruit trees garlic grapes grapes eggplant olives onion potato, white/Irish artichoke/asparagus strawberry Application Rate Application rate (Ib/acre) 3.98 5.985 3.96 5.985 3.96 0.99 1.98 1.98 3.96 3.96 1.485 5.845 3.96 1.485 3.96 1.98 1.485 3.895 1.485 Application Method Application method air ground air ground air air air air air air air ground air air air air air air air 50 ------- Scenario Catomato WirrigSTD CAtomatoSTD CARightofWayfRLF, CAImperviousRLF CAwheatRLF Tier 1 Rice Model Uses Represented by Scenario tomato, tomatillo groundcherry rights-of-way wheat rice Application Rate 1.485 1.485 3.96 1.485 0.99 Application Method ground air air air air 1 Uses assessed based on memorandum from SRRD (Verification Memorandum for Pendimethalin for Red Legged Frog Assessment) dated 2/17/2009. 3.2 Aquatic Exposure Assessment 3.2.1 Modeling Approach Aquatic exposures are quantitatively estimated for all of assessed uses using scenarios that represent high exposure sites for pendimethalin use. Each of these sites represents a 10 hectare field that drains into a 1-hectare pond that is 2 meters deep and has no outlet. Exposure estimates generated using the standard pond are intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man-made and natural ponds, and intermittent and first-order streams. As a group, there are factors that make these water bodies more or less vulnerable than the standard surrogate pond. Static water bodies that have larger ratios of drainage area to water body volume would be expected to have higher peak EECs than the standard pond. These water bodies will be either shallower or have large drainage areas (or both). Shallow water bodies tend to have limited additional storage capacity, and thus, tend to overflow and carry pesticide in the discharge whereas the standard pond has no discharge. As watershed size increases beyond 10 hectares, at some point, it becomes unlikely that the entire watershed is planted to a single crop, which is all treated with the pesticide. Headwater streams can also have peak concentrations higher than the standard pond, but they tend to persist for only short periods of time and are then carried downstream. Crop-specific management practices for all of the assessed uses of pendimethalin were used for modeling, including application rates, number of applications per year, application intervals, and the first application date for each crop. The Tier 1 Rice Model calculates the water column concentration in a flooded rice paddy on the day of application, accounting only for sorption to sediment as a dissipation mechanism. KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides. This tool can also be used to estimate pesticide concentrations in fish tissues consumed by humans (i.e., filets). The bioaccumulation portion of KABAM is based upon work by Arnot and Gobas (2004) who parameterized a bioaccumulation model based on PCBs and some pesticides (e.g., 51 ------- lindane, DDT) in freshwater aquatic ecosystems. KABAM relies on a chemical's octanol- water partition coefficient (KOW) to estimate uptake and elimination constants through respiration and diet of organisms in different trophic levels. Pesticide tissue residues are calculated for different levels of an aquatic food web. The model then uses pesticide tissue concentrations in aquatic animals to estimate dose- and dietary-based exposures and associated risks to mammals and birds consuming aquatic organisms, using an approach that is similar to the TREX model (USEPA 2008). Input parameters for KABAM are given in Appendix K. 3.2.2 Model Inputs Pendimethalin is a herbicide used on a wide variety of food, non-food crops, and non- agricultural sites. Pendimethalin environmental fate data used for generating model parameters is listed in Table 2.1 in Section 2.4.1. The input parameters for PRZM and EXAMS are in Table 3-2. Application dates were generally one to two weeks before the crop emergence date in the PRZM scenario, as pendimethalin is a pre-emergence/pre- plant herbicide. Table 3-2 Summary of PRZM/EZAMS Environmental Fate Data Used for Aquatic Exposure Inputs for Pendimethalin Endangered Species Assessment for the CRLF1 Fate Property Molecular Weight Henry's constant Vapor Pressure Solubility in Water Photolysis in Water Aerobic Soil Metabolism Half-lives Hydrolysis Aerobic Aquatic Metabolism (water column) Anaerobic Aquatic Metabolism (benthic) Koc Application rate and frequency Application intervals Chemical Application Method (CAM) Value (unit) 281.31 8.6E-7 atm-m3/mol 3.0E-5 mmHg 3.0mg/Lat25°C 42 day half -life (12 hours light/dark) 172 days Stable 330 day half-life (total system) 3x factor not used due to long half- life from single study 208 day half-life 17040 mL/g o.c. MRID (or source) VP/solubility 00153766 00153762; lOx actual value as per Input Parameter Guidance (IPG) 00153763 40185 104; deviation from IPG as explained in 1997 RED 00106777 47385201 40813501; upper 90th %ile confidence bound 43041901 (average of 5 values) See table 3.1 Soil appl;ied 52 ------- Fate Property Application Efficiency Spray Drift Fraction Air Diffusion coefficient Enthalpy of Vaporization Value (unit) 0.99 ground 0.95 aerial 0.01 ground 0.05 aerial 3427 cm2/day 20 kcal/mol MRID (or source) IPG IPG = 1.55/(MW)A0.65 PRZM default 1 - Inputs determined in accordance with EFED "Guidance for Chemistry and Management Practice Input Parameters for Use in Modeling the Environmental Fate and Transport of Pesticides" dated February 28, 2002 3.2.3 Results The aquatic EECs for the various scenarios and application practices are listed in Table 3-3. Most peak exposures were 16 ppb or below. Most exposures were dominated by spray drift. Table 3-3 Aquatic EECs (ug/L) for Pendimethalin Uses in California PRZM Scenario CAcolecropRLF Cacitrus WirrigSTD a Cagrapes_WirrigSTD, CAwinegrapesRLF CApotatoRLF CAtomatoSTD CAmelonsRLF CAgarlicRLF CAStrawberry- noplasticRLF CAOnion WirrigSTD Cacotton WirrigSTD CAwheatRLF CAalmond WirrigSTD CAcornOP Cacitrus WirrigSTD a CAOliveRLF Cafruit WirrigSTD b CAalfalfa WirrigOP Cagrapes_WirrigSTD, CAwinegrapesRLF CAalmond WirrigSTD c CArowcropRLF d Application Rate (Ib/A) 0.99 5.985 5.845 1.485 1.485 1.485 1.485 1.485 1.98 1.98 1.485 5.985 1.98 3.96 3.96 3.96 3.98 3.96 3.96 3.895 Aerial/ Ground A G G A A A A A A A A G A A A A A A A A Specific Crop Several cole crops Several citrus crops grapes potato, white/Irish groundcherry eggplant garlic strawberry onion cotton wheat several several several olives several alfalfa grapes several artichoke/asp aragus Peak EEC (ppb) 3.16 3.42 4.06 4.14 4.21 4.22 4.31 4.74 5.55 5.75 6.10 6.56 6.84 11.06 11.16 11.18 11.28 11.44 11.71 11.92 21 -day EEC (ppb) 1.29 0.94 1.31 0.99 1.10 1.04 1.15 1.92 1.35 1.54 2.81 2.38 2.00 2.65 2.78 3.03 3.11 2.94 3.68 4.04 60-day EEC (ppb) 0.98 0.58 0.95 0.57 0.66 0.62 0.73 1.36 0.80 0.99 2.13 1.61 1.54 1.52 1.70 1.85 1.95 1.83 2.30 2.86 53 ------- CAForestryRLF e Tier 1 Rice Model CARightofWayfRLF, CAImperviousRLF f 3.96 0.99 3.96 A A A several rice several 16.60 48 1.74 6.41 — 0.55 4.93 — 0.36 a This scenario represents calamondin, citron (citrus), citrus hybrids other than tangelo, grapefruit, kumquat, lemon, lime, orange, pummelo (shaddock), and tangelo. b This scenario represents apple, apricot, cherry, crabapple, fig, loquat, nectarine, peach, pear, pepino (melon pear), plum, pomegranate, prune, quince, and small fruits. 0 This scenario represents almond, beech nut, brazil nut, butternut, cashew, chestnut, chinquapin, filbert (hazelnut), hickory nut, macadamia nut (bushnut), mayhaw (hawthorn), pecan, pistachio, walnut (English or black). d This scenario represents artichoke, asparagus, beans, carrot (including tops), garbanzos (including chick peas), legume vegetables, peanuts (unspecified), peas, and pepper. e This scenario represents forestry and Christmas tree plantations. f These combined scenarios represents airports/landing fields, commercial/industrial lawns, golf course turf, industrial areas (outdoor), mulch, ornamental and/or shade trees, ornamental ground cover, ornamental herbaceous plants, ornamental lawns and turf, ornamental non-flowering plants, ornamental sod farm (turf), ornamental woody shrubs and vines, paved areas (private roads/sidewalks), Rights-of-way, fencerows, hedges recreation area lawns, residential lawns, and shelterbelt plantings. Combined EEC is 50% Impervious scenario with 1% of application rate and no drift, and 50% Rights-of-way scenario. 3.2.4 Existing Monitoring Data A critical step in the process of characterizing EECs is comparing the modeled estimates with available surface water monitoring data. Included in this assessment are pendimethalin data from the USGS NAWQA program (http://water.usgs.gov/nawqa) and data from the California Department of Pesticide Regulation (CDPR). 3.2.4.1 USGS NAWQA Surface Water Data Data for pendimethalin and its degradate hydroxypendamethalin were downloaded from the NAWQA Data Warehouse site on March 30, 2009. The data was restricted to California sampling stations. There were 604 measurements of pendimethalin in the Sacramento River and San Joaquin-Tulare River basins. There was measureable pendimethalin in 319 of the 604 samples (53% positive). The highest concentration recorded (0.679 ppb) was at a station called "Highline Cn Spill Nr Hilmar Ca" in the San Joaquin-Tulare River Basin. All 9 measurements at this site were positive for pendimethalin, with a range of 0.262 to 0.679 ppb. All 8 measurements of hydroxypendimethalin in surface water were in the San Joaquin- Tulare basin. All were non-detect (<0.143 ppb). 3.2.4.2 USGS NAWQA Groundwater Data 54 ------- There were 589 measurements of pendimethalin in the NAWQA data for the Sacramento River and San Joaquin-Tulare River Basins. There was only one positive result (0.0138 ppb) in Stanislaus County (San Joaquin-Tulare basin). All 61 measurements of pendimethalin in ground water were in the San Joaquin-Tulare basin. All were non-detect (<0.143 ppb). 3.2.4.3 California Department of Pesticide Regulation (CPR) Data Data for pendimethalin were downloaded from the California surface water monitoring database on March 19, 2009. There were 565 measurements of pendimethalin in the Sacramento River valley (33 were positive), and 1802 measurements (326 were positive) in the San Joaquin River valley. The maximum concentration in the Sacramento River valley was 0.7 ppb, and it was 3.5 ppb in the San Joaquin valley. The data for all stations in the two valleys are given in Figure 3.1 below. 0.8 i 0.7 0.6 0.5 £ 0.4 0- 0.3 0.2 0.1 Pendimethalin [ug/L] in Sacramento Valley Streams 5/7/1990 1/31/1993 10/28/1995 7/24/1998 4/19/2001 date 1/14/2004 10/10/2006 7/6/2009 55 ------- Pendimethalin [ug/L] in San Joaquin Valley Streams imethalin |v o c ppb Pend n I- 4» • • • • » . . ': . !'»i :«i.ijiii- 5/7/1990 1/31/1993 10/28/1995 7/24/1998 4/19/2001 1/14/2004 10/10/2006 date • Cone [ug/L] Figure 3.1 California DPR surface water monitoring data 3.2.4.4 Atmospheric Monitoring Data Pendimethalin has been detected in air in an agricultural setting (Merced River basin downstream from McSwain dam) in California (Vogel et al. 2008). Of 23 rainwater samples taken, 78% were positive, with a maximum concentration of 0.143 |ig/L, and a median of 0.021 |ig/L. Sampling was conducted in 2003 and 2004. As explained above in section 2.10.1.1, volatilization and redeposition is not quantifiable with currently approved models. However, analysis of water modeling results with and with soil volatilization routines invoked indicate that the volatilization effect is small for pendimethalin, and airborne exposure is dominated by spray drift at the time of application. 3.2.4.5 Spray Drift Buffer and Downstream Dilution Analysis for Action Area Because pendimethalin use is documented in 54 of 58 California counties, and because it is semi-volatile and has been detected in rainwater, the Action Area is considered to be the entire state. Spray drift and downstream dilution analysis for the Action Area were therefore not conducted. 56 ------- 3.3 Terrestrial Animal Exposure Assessment T-REX (Version 1.3.1) is used to calculate dietary and dose-based EECs of pendimethalin for the CRLF and its potential prey (e.g. small mammals and terrestrial insects) inhabiting terrestrial areas. EECs used to represent the CRLF are also used to represent exposure values for frogs serving as potential prey of CRLF adults. T-REX simulates a 1-year time period. For this assessment, spray applications of pendimethalin are considered, as discussed in below. Terrestrial EECs for foliar formulations of pendimethalin were derived for the uses summarized in Table 3.4. Given that no data on interception and subsequent dissipation from foliar surfaces is available for pendimethalin, a default foliar dissipation half-life of 35 days is used based on the work of Willis and McDowell (1987). Use of specific input values, including number of applications, application rate and application interval are provided in Table 3.4. Outputs from T-REX is available in Appendix E. Table 3-4 Input Parameters for Foliar Applications Used to Derive Terrestrial EECs for Pendimethalin with T-REX Use Sites walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of-way, fencerows, hedgerows, mulch, industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa Asparagus, artichoke golf course turf, airports/landing fields residential lawns Shallot, onion, corn (sweet, pop, field) Carrot Sunflower Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, cowpea (southern pea, black- eyed bean), Wheat, pepper, pepino (melon pear), groundcherry, eggplant Strawberry Legume vegetables Rice, mustard cabbage (gai choy, pak-choi), kohlrabi, cauliflower, cabbage (Chinese), cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables Application rate (Ibs ai/A) 6.0 4.0 3.9 3.5 3.0 2.0 1.9 1.73 1.485 1.425 1.485 1.24 1.0 Number of Applications 1 1 1 1 2 (30 day interval) 1 1 T-REX is also used to calculate EECs for terrestrial insects exposed to pendimethalin. Dietary-based EECs calculated by T-REX for small and large insects (units of a.i./g) are used to bound an estimate of exposure to terrestrial insects. Available acute contact 57 ------- toxicity data for bees exposed to pendimethalin (in units of jig a.i./bee), are converted to jig a.i./g (of bee) by multiplying by 1 bee/0.128 g. The EECs are later compared to the adjusted acute contact toxicity data for bees in order to derive RQs. For modeling purposes, exposures of the CRLF to pendimethalin through contaminated food are estimated using the EECs for the small bird (20 g) which consumes small insects. Dietary-based and dose-based exposures of potential prey are assessed using the small mammal (15 g) which consumes short grass. Upper-bound Kenega nomogram values reported by T-REX for these two organism types are used for derivation of EECs for the CRLF and its potential prey (Table 3.5). Dietary-based EECs for small and large insects reported by T-REX as well as the resulting adjusted EECs are available in Table 3.6. An example output from T-REX v. 1.3.1 is available in Appendix E. Table 3-5 Upper-bound Kenega Nomogram EECs for Dietary- and Dose-based Exposures of the CRLF and its Prey to Pendimethalin Application rate 6.0 4.0 3.9 3.5 3.0 2.0 1.9 1.73 1.485 1.425 1.485 (2 applications) 1.24 1.0 EECs for CRLF (including other frog prey) Dietary-based EEC (ppm) 810 540 526 472 405 270 256 234 200 192 301 167 135 Dose-based EEC (mg/kg-bw) 922 615 600 538 461 307 292 267 228 219 342 191 154 EECs for Prey (small mammals) Dietary-based EEC (ppm) 1,440 960 936 840 720 480 456 415 356 242 535 298 240 Dose-based EEC (mg/kg-bw) 1374 915 892 801 686 458 435 396 340 326 510 284 229 Table 3-6 EECs (ppm) for Indirect Effects to the Terrestrial-Phase CRLF via Effects to Terrestrial Invertebrate Prey Items Application Rate 6.0 4.0 3.9 3.5 3.0 2.0 1.9 1.73 Small Insect 810 540 527 473 405 270 257 234 Large Insect 90 60 59 53 45 30 29 26 58 ------- 1.485 1.425 1.485 (2 applications) 1.24 1.0 200 192 342 167 135 22 21 38 19 15 3.4 Terrestrial Plant Exposure Assessment TerrPlant (Version 1.1.2) is used to calculate EECs for non-target plant species inhabiting dry and semi-aquatic areas. Parameter values for application rate and drift assumption are based upon the use and related application method (Table 3.7). A runoff value of 0.01 is utilized based on pendimethalin's solubility, which is 0.28 mg/L. For aerial and ground application methods, drift is assumed to be 5% and 1%, respectively. EECs relevant to terrestrial plants consider pesticide concentrations in drift and in runoff. These EECs are listed by use in Table 3.7. An example output from TerrPlant v.1.2.2 is available in Appendix F. Table 3-7 TerrPlant Inputs and Resulting EECs for Plants Inhabiting Dry and Semi-aquatic Areas Exposed to Pendimethalin via Runoff and Drift Application rate (Ibs a.i./A) 6.0 4.0 4.0 3.9 3.9 3.5 3.5 3.0 3.0 2.0 2.0 1.9 1.9 1.73 1.73 1.485 1.485 1.24 1.24 1.0 1.0 Application method Foliar - ground Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Foliar - ground Foliar - aerial Drift Value (%) 1 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 Spray drift EEC (Ibs a.i./A) 0.060 0.040 0.200 0.039 0.195 0.035 0.175 0.030 0.150 0.020 0.100 0.019 0.095 0.017 0.087 0.015 0.074 0.012 0.062 0.010 0.050 Dry area EEC (Ibs a.i./A) 0.120 0.080 0.24 0.078 0.234 0.070 0.210 0.060 0.180 0.040 0.120 0.038 0.114 0.035 0.104 0.030 0.089 0.025 0.074 0.020 0.060 Semi-aquatic area EEC (Ibs a.i./A) 0.660 0.440 0.600 0.429 0.585 0.385 0.525 0.330 0.450 0.220 0.300 0.209 0.285 0.190 0.260 0.163 0.223 0.136 0.186 0.110 0.150 59 ------- 4.0 Effects Assessment This assessment evaluates the potential for pendimethalin to directly or indirectly affect the CRLF or affect its designated critical habitat. As discussed in Section 2.7, assessment endpoints for the CRLF effects determination include direct toxic effects on the survival, reproduction, and growth of CRLF, as well as indirect effects, such as reduction of the prey base or modification of its habitat. In addition, potential modification of critical habitat is assessed by evaluating effects to the PCEs, which are components of the critical habitat areas that provide essential life cycle needs of the CRLF. Direct effects to the aquatic-phase of the CRLF are based on toxicity information for freshwater fish, while terrestrial-phase effects are based on avian toxicity data, given that birds are generally used as a surrogate for terrestrial-phase amphibians. Because the frog's prey items and habitat requirements are dependent on the availability of freshwater fish and invertebrates, small mammals, terrestrial invertebrates, and aquatic and terrestrial plants, toxicity information for these taxa are also discussed. Acute (short-term) and chronic (long-term) toxicity information is characterized based on registrant-submitted studies and a comprehensive review of the open literature on pendimethalin. As described in the Agency's Overview Document (U.S. EPA, 2004), the most sensitive endpoint for each taxon is used for risk estimation. For this assessment, evaluated taxa include freshwater fish (also as a surrogate for aquatic-phase amphibians), freshwater invertebrates, aquatic plants, birds (surrogate for terrestrial-phase amphibians), mammals, terrestrial invertebrates, and terrestrial plants. Toxicity endpoints are established based on data generated from guideline studies submitted by the registrant, and from open literature studies that meet the criteria for inclusion into the ECOTOX database maintained by EPA/Office of Research and Development (ORD) (U.S. EPA, 2004). Open literature data presented in this assessment were obtained from ECOTOX on 10/31/2008. In order to be included in the ECOTOX database, papers must meet the following minimum criteria: (1) the toxic effects are related to single chemical exposure; (2) the toxic effects are on an aquatic or terrestrial plant or animal species; (3) there is a biological effect on live, whole organisms; (4) a concurrent environmental chemical concentration/dose or application rate is reported; and (5) there is an explicit duration of exposure. Data that pass the ECOTOX screen are evaluated along with the registrant-submitted data, and may be incorporated qualitatively or quantitatively into this endangered species assessment. In general, effects data in the open literature that are more conservative than the registrant-submitted data are considered. The degree to which open literature data are quantitatively or qualitatively characterized for the effects determination is dependent on whether the information is relevant to the assessment endpoints (i.e., maintenance of CRLF survival, reproduction, and growth) identified in Section 2.8. For example, endpoints such as behavior modifications are likely to be qualitatively evaluated, because 60 ------- quantitative relationships between modifications and reduction in species survival, reproduction, and/or growth are not available. Although the effects determination relies on endpoints that are relevant to the assessment endpoints of survival, growth, or reproduction, it is important to note that the full suite of sublethal endpoints potentially available in the effects literature (regardless of their significance to the assessment endpoints) are considered to define the action area for pendimethalin. Citations of all open literature not considered as part of this assessment because they were either rejected by the ECOTOX screen or accepted by ECOTOX but not used (e.g., the endpoint is less sensitive) are included in Appendix G. Appendix G also includes a rationale for rejection of those studies that did not pass the ECOTOX screen and those that were not evaluated as part of this endangered species risk assessment. A detailed spreadsheet of the available ECOTOX open literature data, including the full suite of lethal and sublethal endpoints is presented in Appendix G. Appendix I also includes a summary of the human health effects data for pendimethalin. In addition to registrant-submitted and open literature toxicity information, other sources of information, including use of the acute probit dose response relationship to establish the probability of an individual effect and reviews of the Ecological Incident Information System (EIIS), are conducted to further refine the characterization of potential ecological effects associated with exposure to pendimethalin. A summary of the available aquatic and terrestrial ecotoxicity information, use of the probit dose response relationship, and the incident information for pendimethalin are provided in Sections 4.1 through 4.4, respectively. There are no available toxicity information on the degradates of pendimethalin. A detailed summary of the available ecotoxicity information for all pendimethalin formulated products are presented in Appendix A. In regards to mixtures of other products containing pendimethalin, only three products (EPA Reg. Nos. 241-331, 241-376 and 5905-495) have definitive product LD50 values with associated confidence intervals. Although there are no 95% confidence intervals associated with the pendimethalin technical, an evaluation of the three products listed above show that for EPA Reg. Nos. 241-331 and 241-376, the product LDso values can be attributed solely to the toxicity of pendimethalin. When these product LD50s (3506 and 2500 mg/kg, respectively) and associated confidence intervals (892-1223 and 504-800 mg/kg, respectively) are adjusted for the percent pendimethalin (30.24% and 25.4%, respectively), the adjusted LD50 values for EPA Reg. No. 241-331 (1060 mg/kg, CI: 892-1223) and EPA Reg. No. 241-376 (635 mg/kg, CI: 504-800) are not lexicologically distinct from the LDso of pendimethalin (1050 mg/kg). Similarly, for EPA Reg. No. 5905-495, the toxicity can be attributed to propanil. When the LD50 for this product (1110 mg/kg) and its confidence interval (913-1360 mg/kg) are adjusted for the percent propanil (33.7%), the adjusted LD50 value of 374 mg/kg (CI: 308-458 mg/kg) is within a factor of two of the confidence interval for propanil (1080 mg/kg; CI: 868-1343 mg/kg) and the difference is not considered to be lexicologically significant. 61 ------- Because the active ingredients are not expected to have similar mechanisms of action, metabolites, or toxicokinetic behavior, it is reasonable to conclude that an assumption of dose-addition would be inappropriate. Consequently, an assessment based on the toxicity of pendimethalin is the only reasonable approach that employs the available data to address the potential acute risks of the formulated products. Additional information can be found in Appendix B. 4.1 Evaluation of Aquatic Ecotoxicity Studies Table 4-1 summarizes the most sensitive aquatic toxicity endpoints for the CRLF, based on an evaluation of both the submitted studies and the open literature, as previously discussed. A brief summary of submitted and open literature data considered relevant to this ecological risk assessment for the CRLF is presented below. Additional information is provided in Appendix A. Table 4-1 Freshwater Aquatic Toxicity Profile for Pendimethalin Assessment Endpoint Acute Direct Toxicity to Aquatic- Phase CRLF Chronic Direct Toxicity to Aquatic- Phase CRLF Indirect Toxicity to Aquatic -Phase CRLF via Acute Toxicity to Freshwater Invertebrates (i.e. prey items) Indirect Toxicity to Aquatic -Phase CRLF via Chronic Toxicity to Freshwater Invertebrates (i.e. prey items) Indirect Toxicity to Aquatic -Phase CRLF via Toxicity to Non-vascular Aquatic Plants Indirect Toxicity to Aquatic -Phase CRLF via Toxicity to Vascular Aquatic Species Rainbow trout Fathead minnow Daphnia magna Waterflea (Daphnia magna) Marine diatom Skeletonem a costatum Duckweed (Lemna gibba) Toxicity Value Used in Risk Assessment LC50 =138 ppb NOAEC = 6.3 ppb EC50 = 280 ppb NOAEC = 14.5 ppb EC50 = 5.2 ppb EC50=12..5 ppb Describe effect (i.e. mortality, growth, reproduction) mortality reduction of egg production mortality reduced production of Daphnia young growth growth Citation MRID# (Author & Date) 00046291 Sleight, 1972 00037940 EG&G Bionomics, 1975 00059738 LeBlanc, 1976 00100504 Graney, 1981 42372205 Hughes, 1992 42137101 Hughes, 1992 Study Classification Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable 62 ------- Assessment Endpoint Plants Species Toxicity Value Used in Risk Assessment Describe effect (i.e. mortality, growth, reproduction) Citation MRID# (Author & Date) Study Classification Toxicity to aquatic fish and invertebrates is categorized using the system shown in Table 4-2 (U.S. EPA, 2004). Toxicity categories for aquatic plants have not been defined. Table 4-2 Categories of Acute Toxicity for Fish and Aquatic Invertebrates LCSO (ppm) <0.1 >0.1-1 >1-10 > 10 - 100 >100 Toxicity Category Very highly toxic Highly toxic Moderately toxic Slightly toxic Practically nontoxic 4.1.1 Toxicity to Freshwater Fish Given that no pendimethalin toxicity data are available for aquatic-phase amphibians; freshwater fish data were used as a surrogate to estimate direct acute and chronic risks to the CRLF. Freshwater fish toxicity data were also used to assess potential indirect effects of pendimethalin to the CRLF. Effects to freshwater fish resulting from exposure to pendimethalin could indirectly affect the CRLF via reduction in available food. As discussed in Section 2.5.3, over 50% of the prey mass of the CRLF may consist of vertebrates such as mice, frogs, and fish (Hayes and Tennant, 1985). A summary of acute and chronic freshwater fish data, including data from the open literature, is provided below in Sections 4.1.1.1 through 4.1.1.3. 4.1.1.1 Freshwater Fish: Acute Exposure (Mortality) Studies Three acute freshwater studies using the technical pendimethalin and seven using formulations were submitted to the Agency. For the technical pendimethalin studies, the LCso for the three species offish range from 138 ppb to 418 ppb. For the formulated product studies, three species offish range from 520 ppb formulation to 86,600 ppb formulation. The species for the three technical pendimethalin studies are bluegill sunfish, rainbow trout, and channel catfish. The LCso for the species are 199 ppb, 138 ppb, and 418 ppb, respectively. The species for the seven formulated product studies are bluegill sunfish, rainbow trout, and channel catfish. The LCSO for the formulation studies are listed below: AI1 LCsn (ppm formulation) LCsn (ppm a.i. calculated) MPJD 63 ------- Bluegill sunfish Prowl 3E Lepomis macrochims 34.4% 1.04 ppm 0.358ppm 00037927 Rainbow trout Prowl 3E Oncorhynchus mykiss 34.4% 1.0 ppm 0.344 ppm 00037927 Bluegill sunfish Prowl 4E Lepomis macrochims 42.3% 0.92 ppm 0.389 ppm 00037927 Rainbow trout Prowl 4E Oncorhynchus mykiss 42.3% 0.52 ppm 0.220 ppm 00037927 Bluegill sunfish Avenge 2AS Lepomis macrochims 31.8% 90.4 ppm 28.747 ppm 00037927 Rainbow trout Avenge 2AS Oncorhynchus mykiss 31.8% 86.6 ppm 27.539 ppm 00037927 Channel catfish Prowl 4E Ictaluruspunctatus 42.3% 1.9 ppm 0.804 ppm 00131773 1 AI refers to active ingredient percentage. The formulated product is also displayed. The endpoint selected for the assessment is the rainbow trout study using technical grade pendimethalin and it had an LCso of 138 ppb (C.I. 110-170) since it is the most sensitive of the freshwater fish. The MRID number is 00046291. 4.1.1.2 Freshwater Fish: Chronic Exposure (Early Life Stage and Reproduction) Studies One chronic freshwater fish study (MRID00037940) was submitted to the Agency. This study is a Fathead minnow (Pimephalespromelets) full life cycle study using a technical grade pendimethalin. The 288-day NOAEC is 6.3 ppb (0.0063 ppm). The NOAEC is based on reduction of egg production. The LOAEC = 9.8 ppb (0.0098 ppm) based on reduction of egg production. Reduced hatchability was also observed at 22 and 43 ppb. 4.1.1.3 Freshwater Fish: Sublethal Effects and Additional Open Literature Information The ecotoxicity studies from the ECOTOX database provided endpoints that are less sensitive than the submitted rainbow trout study (MRID 00046291) which had an LCso of 138 ppb. No useful chronic freshwater invertebrate studies were found in the ECOTOX database with NOAEC more sensitive than the submitted fathead minnow study (MRID 00037940). 4.1.1.4 Aquatic-phase Amphibian: Acute and Chronic Studies No studies are available. 64 ------- 4.1.2 Toxicity to Freshwater Invertebrates Freshwater invertebrate toxicity data were used to assess potential indirect effects of pendimethalin to the CRLF. Effects to freshwater invertebrates resulting from exposure to pendimethalin could indirectly affect the CRLF via reduction in available food items. As discussed in Section 2.5.3, the main food source for juvenile aquatic- and terrestrial- phase CRLFs is thought to be aquatic invertebrates found along the shoreline and on the water surface, including aquatic sowbugs, larval alderflies and water striders. A summary of acute and chronic freshwater invertebrate data, including data published in the open literature, is provided below in Sections 4.1.2.1 through 4.1.2.3. 4.1.2.1 Freshwater Invertebrates: Acute Exposure (Mortality) Studies Three acute freshwater invertebrate studies were submitted to the Agency: two studies using the waterflea Daphnia magna and one using crayfish, Procambarus simulans. A Daphnia magna study using technical grade pendimethalin had an ECso of 280 ppb (C.I. 230-330) and is considered to be an acceptable study. The other Daphnia magna study used the formulation containing 45.6% active ingredient with the EC50 = 5.1 ppm (5100 ppb) formulation. This study is considered to be acceptable for formulated study. The crayfish study is categorized as supplemental due to the precipitate being observed in concentrations of 1.0 ppm and more; the dissolved O2 concentration is less than 40% of saturation; and DMSO was used as a solvent which tends to increase mortalities rather than decrease them. This ECso for this study is greater than 1.0 ppm (1000 ppb). Acute toxicity of pendimethalin technical to freshwater invertebrates is categorized as highly toxic and moderately toxic. Pendimethalin formulation is categorized as moderately toxic. The most sensitive freshwater invertebrate species tested is Daphnia magna, with a 48- hour ECso value of 280 |ig/L (MRTD: 00059738), is used for deriving risk quotients for the CRLF prey. 4.1.2.2 Freshwater Invertebrates: Chronic Exposure (Reproduction) Studies One chronic freshwater invertebrate study (MRID 00100504) was submitted to the Agency. This study is a Daphnia magna life cycle study using a technical grade pendimethalin. The 21-day NOAEC is 14.5 ppb (0.0145 ppm). The NOAEC is based on reduced production of Daphnia. LOAEC = 0.0172 ppm (17.2 ppb). Mortality was observed in the study with 100% mortality at the 2 highest dose levels of 35.8 and 74.2 ppb. No appreciable mortality observed at 3 lowest concentration levels of 4.3, 8.2, and 14.5 ppb. Reduction of productivity of 50% occurred at 22.1 and 17.5 ppb concentration levels. 65 ------- 4.1.2.3 Freshwater Invertebrates: Sublethal Effects and Open Literature Data The ecotoxicity studies from the ECOTOX database provided endpoints that are less sensitive than the submitted Daphnia magna study (MRID 00059738) which had an of 280 ppb. No useful chronic freshwater invertebrate studies were found in the ECOTOX database with NOAEC more sensitive than the submitted Daphnia magna study (MRID 00100504). 4.1.3 Toxicity to Aquatic Plants Aquatic plant toxicity studies were used as one of the measures of effect to evaluate whether pendimethalin may affect primary production and the availability of aquatic plants as food for CRLF tadpoles. Primary productivity is essential for indirectly supporting the growth and abundance of the CRLF. Only laboratory studies were used to determine whether pendimethalin may cause direct effects to aquatic plants since there are no available field studies to evaluate the effects of pendimethalin to aquatic plants. A summary of the laboratory data for aquatic plants is provided in Sections 4.1.3.1 and 4.1.3.2 . 4.1.3.1 Aquatic Plants: Laboratory Data Aquatic plant toxicity data submitted to the Agency show a range of EC50 values from 5.2 ppb to > 174 ppb. The most sensitive species tested are the green algae and marine diatom and the least sensitive species is the cyanobacteria (blue-green algae). Below is a listing of the species tested and their toxicity value: Green algae (Selenastrum capricornutum) Marine diatom (Skeletonema costatum) Freshwater diatom (Navicula pelliculosa) Blue-green algae (Anabaena flos-aquae) Duckweed (Lemna gibba) EC.n (PPb) 5.4 ppb 5.2 ppb 6.7 ppb >174 ppb 12.5 ppb NOAEL 3.0 0.7 3.2 98 5.6 MRID 42372204 42372205 42372206 42372207 42137101 The endpoint selected for the assessment is the marine diatom study using technical grade pendimethalin had an ECso of 5.2 ppb since it is most sensitive of the aquatic plants tested. In addition, the duckweed is the only vascular aquatic plant tested and will be used for assessing aquatic habitat. The ECso for the duckweed is 12.5 ppb. 66 ------- 4.1.3.2 Freshwater Field Studies No studies are available. 4.2 Toxicity of Pendimethalin to Terrestrial Organisms Table 4.3 below summarizes the most sensitive terrestrial toxicity endpoints for the CRLF, based on an evaluation of both the submitted studies and the open literature. A brief summary of submitted and open literature data considered relevant to this ecological risk assessment for the CRLF is presented below. Table 4-3. Terrestrial Toxicity Profile for Pendimethalin Assessment Endpoint Acute Dose- based Direct Toxicity to Terrestrial- Phase CRLF Acute Dietary- based Direct Toxicity to Terrestrial- Phase CRLF Chronic Direct Toxicity to Terrestrial- Phase CRLF Indirect Toxicity to Terrestrial- Phase CRLF (via acute toxicity to mammalian prey items) Indirect Toxicity to Terrestrial- Phase CRLF (via chronic toxicity to mammalian prey items) Indirect Toxicity to Terrestrial- Species Mallard duck Bobwhite quail Mallard duck Rat Rat Honey bee Toxicity Value Used in Risk Assessment LD50=1421 mg/kg-bw LC50 = 4187 ppm NOAEC=141 ppm LD50 = 1050 mg/kg-bw NOAEL = 25 mg/kg-bw (500 ppm) LD50 = >49.8 ugm/bee Describe effect (i.e. mortality, growth, reproduction) mortality mortality 14-day survivor bodyweight mortality decreases in the number of pups born and pup weights mortality Citation MRID# (Author & Date) 00059739 Fink, 1976 00026675 Fink, 1973 44907601 Beavers, 1996 00026657 41725203 00099890 Atkins, Study Classification Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable 67 ------- Assessment Endpoint Phase CRLF (via acute toxicity to terrestrial invertebrate prey items) Indirect Toxicity to Terrestrial- and Aquatic -Phase CRLF (via toxicity to terrestrial plants) Species Emergence Monocots Seedling Emergence Dicots Vegetative Vigor Monocots Vegetative Vigor Dicots Toxicity Value Used in Risk Assessment Ryegrass EC25 = 0.01 Ib ai/A Lettuce EC25 = 0.09 Ibai/A Ryegrass EC25 = 0.034 Ibai/A Lettuce EC25 = 0.10 Ib ai/A Describe effect (i.e. mortality, growth, reproduction) Dry weight Dry weight Dry weight Dry weight Citation MRID# (Author & Date) 42372201 Chetram, 1992 42372201 Chetram, 1992 42372203 Chetram, 1992 42372203 Chetram, 1992 Study Classification Acceptable Acceptable Acceptable Acceptable Acute toxicity to terrestrial animals is categorized using the classification system shown in Table 4-44 (U.S. EPA, 2004). Toxicity categories for terrestrial plants have not been defined. Table 4-4 Categories of Acute Toxicity for Avian and Mammalian Studies Toxicity Category Very highly toxic Highly toxic Moderately toxic Slightly toxic Practically non-toxic Oral LD50 < 10 mg/kg 10-50 mg/kg 51 -500 mg/kg 501 -2000 mg/kg > 2000 mg/kg Dietary LC50 < 50 ppm 50 - 500 ppm 501 - 1000 ppm 1001 - 5000 ppm > 5000 ppm 4.2.1 Toxicity to Birds As specified in the Overview Document, the Agency uses birds as a surrogate for terrestrial-phase amphibians when amphibian toxicity data are not available (U.S. EPA, 2004). No terrestrial-phase amphibian data are available for pendimethalin; therefore, acute and chronic avian toxicity data are used to assess the potential direct effects of pendimethalin to terrestrial-phase CRLFs. 68 ------- 4.2.1.1 Birds: Acute Exposure (Mortality) Studies Two subacute LCso dietary avian studies and one acute LD50 oral acute avian study using the technical pendimethalin were submitted to the Agency. For the LCso dietary studies, the LC50 for the bobwhite quail is 4187 ppm and the mallard duck is >4640 ppm. For the acute LD50 for the mallard, the LD50 is 1421 mg/kg-bw. The endpoint selected for the assessment is the bobwhite quail's LCso of 4187 ppm (MRID 00026674) and the mallard's LD50 of 1421 mg/kg-bw (00059739). Pendimethalin technical is categorized as slightly toxic on subacute dietary and acute oral basis to birds. No avian studies using pendimethalin formulated product have been submitted to the Agency. 4.2.1.2 Birds: Chronic Exposure (Growth, Reproduction) Studies Two avian reproduction studies were submitted to the Agency. No treatment related effects were observed in the bobwhite quail and the LOAEL is greater than 1410 ppm. The mallard duck study (MRID 44907601) showed the parameter of 14-day survivor bodyweight was reduced at 1410 ppm. The NOAEL for the mallard study is 410 ppm. No other treatment related effects were observed. This study is classified as acceptable. 4.2.1.3 Birds: Open Literature Studies No studies more sensitive than the submitted avian studies were found in the ECOTOX database. 4.2.2 Toxicity to Mammals Mammalian toxicity data are used to assess potential indirect effects of pendimethalin to the terrestrial-phase CRLF. Effects to small mammals resulting from exposure to pendimethalin could also indirectly affect the CRLF via reduction in available food. As discussed in Section 2.5.3, over 50% of the prey mass of the CRLF may consist of vertebrates such as mice, frogs, and fish (Hayes and Tennant, 1985). Most recent data and information on mammalian toxicity comes from Registration Division document entitled "Pendimethalin. Human Health Risk Assessment for the Proposed Food Uses of the Herbicide on Artichoke, Globe; Asparagus; Brassica Head and Stem Vegetables, Subgroup 5A; and Grape (PP#6E7129)", dated August 22, 2007. The document was authored by Debra Rate, Ph.D., Biologist, Alternative Risk Integration and Assessment (ARIA), Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB), Registration Division (RD) (7505P) to Barbara Madden/ Susan Stanton RIMUERB/RD (7505P). This is found in Appendix I. 69 ------- 4.2.2.1 Mammals: Acute Exposure (Mortality) Studies The Agency's rat acute oral assessment endpoint for risk assessment purpose shows the LD50 to be 1250 mg/kg (male) and 1050 mg/kg (female) (MRID 00026657). Pendimethalin is considered to be slightly toxic to mammals on an acute oral basis. 4.2.2.2 Mammals: Chronic Exposure (Growth, Reproduction) Studies A 2-generation reproduction study (MRID 41725203) with pendimethalin was reviewed by HED. The parental systemic NOAEL was 25 mg/kg/day (500 ppm), based on decreased body weight gain and food consumption at the LOAEL of 125 mg/kg/day (2500 ppm). The reproductive/offspring NOAEL is 25 mg/kg/day (500 ppm), based on decreases in the number of pups born and pup weight at the LOAEL of 125 mg/kg/day (2500 ppm). Parental and reproductive NOAELs and LOAELs were based on a generic ratio (1:20) of dietary intake of chemical. The HED Cancer Peer Review Committee classified pendimethalin as a "Group C" (possible human) carcinogen, based on thyroid follicular cell adenomas in rats. The committee recommended a non-quantitative approach (non-linear, RfD approach) since mode of action studies are available that demonstrate that the thyroid tumors are due to a thyroid-pituitary imbalance, and also since pendimethalin was shown to be non- mutagenic in mammalian somatic cells and germ cells. 4.2.2.3 Mammals: Open Literature Studies No studies more sensitive than the submitted mammalian studies were found in the ECOTOX database. 4.2.3 Toxicity to Terrestrial Invertebrates Terrestrial invertebrate toxicity data are used to assess potential indirect effects of pendimethalin to the terrestrial-phase CRLF. Effects to terrestrial invertebrates resulting from exposure to pendimethalin may also indirectly affect the CRLF via reduction in available food. 4.2.3.1 Terrestrial Invertebrates: Acute Exposure (Mortality) Studies Only one acute oral bee toxicity study (MRID ) was submitted to the Agency. This study was authored by Dr. Atkins in 1974. The species tested is the honey bee, Apis mellifera. The LD50 acute oral is greater than 49.8 jig/bee with no mortality observed at the highest tested dose. Pendimethalin is classified as practically non-toxic to the honey bee. 70 ------- 4.2.3.2 Terrestrial Invertebrates: Open Literature Studies No studies more sensitive than the submitted bee study were found in the ECOTOX database. 4.2.4 Toxicity to Terrestrial Plants Terrestrial plant toxicity data are used to evaluate the potential for pendimethalin to affect riparian zone and upland vegetation within the action area for the CRLF. Impacts to riparian and upland (i.e., grassland, woodland) vegetation may result in indirect effects to both aquatic- and terrestrial-phase CRLFs, as well as modification to designated critical habitat PCEs via increased sedimentation, alteration in water quality, and reduction in of upland and riparian habitat that provides shelter, foraging, predator avoidance and dispersal for juvenile and adult CRLFs. Plant toxicity data from both registrant-submitted studies and studies in the scientific literature were reviewed for this assessment. Registrant-submitted studies are conducted under conditions and with species defined in EPA toxicity test guidelines. Sub-lethal endpoints such as plant growth, dry weight, and biomass are evaluated for both monocots and dicots, and effects are evaluated at both seedling emergence and vegetative life stages. Guideline studies generally evaluate toxicity to ten crop species. A drawback to these tests is that they are conducted on herbaceous crop species only, and extrapolation of effects to other species, such as the woody shrubs and trees and wild herbaceous species, contributes uncertainty to risk conclusions. Commercial crop species have been selectively bred, and may be more or less resistant to particular stressors than wild herbs and forbs. The direction of this uncertainty for specific plants and stressors, including pendimethalin, is largely unknown. Homogenous test plant seed lots also lack the genetic variation that occurs in natural populations, so the range of effects seen from tests is likely to be smaller than would be expected from wild populations. The results of the Tier II seedling emergence and vegetative vigor toxicity tests on non- target plants are summarized below in Table 4-55. Table 4-5 Non-target Terrestrial Plant Seedling Emergence and Vegetative Vigor Toxicity (Tier II) Data Crop Species NOAEC (Ib ai/A) EC25 (Ib ai/A) Most sensitive parameter Seedling Emergence Monocots Oat, Avena sativa 0.25 1.0 Plant height 71 ------- Crop Dicots Species Ryegrass, Lolium perenne Corn, Zea mays Onion, Allium cepa Soybean, Glycine max Lettuce, Lactuca saliva Radish, Rhaphanus sativus Tomato, Lycopersicon esculentum Cucumber, Cucumis sativus Cabbage, Brassica oleracea NOAEC (Ib ai/A) 0.065 1 0.5 0.06 2.0 0.063 0.13 0.13 0.25 0.25 EC25 (Ib ai/A) 0.01 0.68 0.08 4.7 0.09 0.86 0.2 2.4 0.44 Most sensitive parameter Dry weight Plant height Dry weight Dry weight Dry weight Plant height Dry weight Plant height Plant height Vegetative Vigor Monocots Dicots Oat, Avena sativa Ryegrass, Lolium perenne Corn, Zea mays Onion, Allium cepa Soybean, Glycine max Lettuce, Lactuca sativa Radish, Rhaphanus sativus Tomato, Lycopersicon esculentum Cucumber, Cucumis sativus Cabbage, Brassica oleracea 0.5 0.0008 2.0 0.50 0.13 0.003 >4.0 0.13 >4.0 2.0 0.78 0.034 2.8 0.56 0.27 0.10 >4.0 0.5 >4.0 4.8 Dry weight Dry weight Plant height Plant height Dry weight Dry weight n/a Dry weight n/a Dry weight 1 EC05 was used in lieu of NOEAC since study was unable to determine NOAEC value 4.3 Use of Probit Slope Response Relationship to Provide Information on the Endangered Species Levels of Concern The Agency uses the probit dose response relationship as a tool for providing additional information on the potential for acute direct effects to individual listed species and aquatic animals that may indirectly affect the listed species of concern (U.S. EPA, 2004). As part of the risk characterization, an interpretation of acute RQ for listed species is discussed. This interpretation is presented in terms of the chance of an individual event (i.e., mortality or immobilization) should exposure at the EEC actually occur for a species with sensitivity to pendimethalin on par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the dose response relationship available from the toxicity study used to establish the acute toxicity measures of effect for each taxonomic group that is relevant to this assessment. The individual effects probability associated with the acute RQ is based on the mean estimate of the slope and an assumption of a probit dose response relationship. In addition to a single effects probability estimate based on the mean, upper and lower estimates of the effects probability are also provided to account for variance in the slope, if available. Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP, Environmental Fate and Effects Division (June 22, 2004). The model allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds of that 72 ------- estimate) as the slope parameter for the spreadsheet. In addition, the acute RQ is entered as the desired threshold. 4.4 Incident Database Review EPA maintains an incident database system (Ecological Incident Information System or EIIS) to track and evaluate accidental kills associated with pesticide use. The likelihood that a particular pesticide caused the incident is classified as "highly probable", "probable", "possible", or "unlikely", based on the information contained in the incident report. A review of the EIIS database for ecological incidents involving pendimethalin was completed on April 16, 2009. The results of this review for terrestrial, plant, and aquatic incidents are discussed below in Sections 4.4.1 through 4.4.3, respectively. A complete list of the incidents involving pendimethalin including associated uncertainties is included as Appendix H. In the years since EPA has maintained the database, a total of 69 incidents were reported, of which 65 related to terrestrial plants. 4.4.1 Terrestrial Incidents There were two incidents involving pendimethalin with alleged adverse effects to terrestrial animals (American Robin, Rock dove, Ground squirrel, and an "unknown" bird.) In a 1998 Kansas incident (1007495-001) twelve robins and rock doves were killed. It is not known as to what site the pendimethalin was applied but was applied nearby. No toxicological analysis was reportedly taken; therefore no confirmation was made as to whether pendimethalin was responsible for the deaths of the 12 birds. Pendimethalin is slightly toxic on an acute oral and subacute dietary basis to birds. It is uncertain that pendimethalin was responsible for the bird deaths. There was also an incomplete incident report (1002343-001) involving surface application of pendimethalin and fertilizer granules to turf with mortality of unknown numbers of ground squirrel and an "unknown" bird. The corpses were analyzed for organophosphates (OP) but not for pendimethalin. No OPs were found. Pendimethalin is slightly toxic on an acute oral and subacute dietary basis to birds and small mammals. It is uncertain and not likely that pendimethalin is responsible for the deaths of the squirrels and the bird. 73 ------- 4.4.2 Plant Incidents Most of these plant incidents related to the treated crop itself, including corn, soybean, potatoes, lawns, azalea bushes, and peanuts. Some of the incidents occur from spray drift and runoff. Of the 65 reported alleged incidents involving pendimethalin, four of the incidents were from spray drift to nearby non-target plants. The severity of these plant incidents ranged from plant damage (most incidents) to mortality. The following reported alleged incidents are from spray drift or runoff from treated sites to non-target plants: 1014702-053 - In Wisconsin, pendimethalin was applied with clomazone to soybean. The two herbicides drifted over to raspberry plants and trees causing some damage to these plants. The damage symptoms observed were more consistent with clomazone damage than pendimethalin. Pendimethalin may have contributed to plant damage but the symptoms of plant damage to non-target plants are more consistent with clomazone. It is probable that pendimethalin may be involved with non-target plant damage. B000621-001 - In 1986 in Illinois, pendimethalin was applied with clomazone to soybean field. The two herbicides drifted over to damage nearby lawns, fruit trees, and vegetable gardens. The damage symptoms observed were more consistent with clomazone damage than pendimethalin. Pendimethalin may have contributed to plant damage but the symptoms of plant damage to non-target plants are more consistent with clomazone. It is probable that pendimethalin may be involved with non-target plant damage. 10009262-054 - In 1996 in California, a greenhouse floor was sprayed with pendimethalin. Vapor from the spray drifted onto potted azaleas plants sitting on the benches above the floor. 172,636 potted azaleas were unmarketable. It is likely that pendimethalin contributed to damage to azaleas from volatility. 1013587-052 - In 1999 in Washington State, pendimethalin was applied to residential ornamentals. Large tree limbs were observed dying. Pendimethalin was analyzed and found present in the foliage of the trees. 4.4.3 Aquatic Incidents There are two aquatic incidents reported involving mortality of 300 and 996 fish, respectively. The fish involved were bass and bluegill (300 fish) and minnow (996 fish), but the incident reports considered pendimethalin involvement "unlikely." In 1998 in Ohio, (incident 1007677-001) pendimethalin and Lorsban were applied to a corn field. One inch of rain fell shortly afterwards and runoff from the corn field ran into a pond. The distance from the field to the pond is from 14-70 feet. Approximately 300 bass and bluegills were later found dead. Fish and water samples were taken but findings 74 ------- were not submitted. Lorsban (chlorpyrifos) is much more toxic to aquatic animals than pendimethalin by three orders of magnitude and is more soluble in water. It is more likely that Lorsban is the cause of the mortality to the fish. Pendimethalin is not expected to kill fish outright from runoff from one inch of rain on a corn field based on its EEC and toxicity. In 1993 in Minnesota, an incident involving the deaths of 996 minnows was reported. There is very little information in this report which indicated that "250 -300 gallons yellow weed killer, Prowl" contributed to the deaths of the minnows in the Schwerin Creek. This information comes from a Minnesota Department of Natural Resources report showing a table of various spill incidents involving pesticides reported to Minnesota. It is likely that a significant spill of concentrated pendimethalin is the cause of deaths of the minnow in the creek. 75 ------- 5.0 Risk Characterization Risk characterization is the integration of the exposure and effects characterizations. Risk characterization is used to determine the potential for direct and/or indirect effects to the CRLF or for modification to its designated critical habitat from the use of pendimethalin risk characterization provides an estimation (Section 5.1) and a description (Section 5.2) of the likelihood of adverse effects; articulates risk assessment assumptions, limitations, and uncertainties; and synthesizes an overall conclusion regarding the likelihood of adverse effects to the CRLF or its designated critical habitat (i.e., "no effect," "likely to adversely affect," or "may affect, but not likely to adversely affect"). 5.1 Risk Estimation Risk is estimated by calculating the ratio of exposure to toxicity. This ratio is the risk quotient (RQ), which is then compared to pre-established acute and chronic levels of concern (LOCs) for each category evaluated (Appendix C). For acute exposures to the CRLF and its animal prey in aquatic habitats, as well as terrestrial invertebrates, the LOG is 0.05. For acute exposures to the CRLF and mammals, the LOG is 0.1. The LOG for chronic exposures to CRLF and its prey, as well as exposures to plants is 1.0. Risk to the aquatic-phase CRLF is estimated by calculating the ratio of exposure to toxicity using l-in-10 year EECs based on the label-recommended pendimethalin usage scenarios summarized in Table 3-3 and the appropriate aquatic toxicity endpoint from Table 4-1. Risks to the terrestrial-phase CRLF and its prey (e.g. terrestrial insects, small mammals and terrestrial-phase frogs) are estimated based on exposures resulting from applications of pendimethalin (Tables 3.5 - 3.6) and the appropriate toxicity endpoint from Table 4.3. Exposures are also derived for terrestrial plants, as discussed in Section 3.7 and toxicity summarized in Section 4.2.4, based on the highest application rates of pendimethalin use within the action area. 5.1.1 Exposures in the Aquatic Habitat 5.1.1.1 Direct Effects to Aquatic-Phase CRLF Direct effects to the aquatic-phase CRLF are based on peak EECs in the standard pond and the lowest acute toxicity value for freshwater fish. In order to assess direct chronic risks to the CRLF, 60-day EECs and the lowest chronic toxicity value for freshwater fish are used. Based on exceedances of the acute LOG (0.05) for listed species, pendimethalin may directly affect the aquatic-phase of the CRLF. The results of the RQ calculations are in Table 5.1 below. 76 ------- Table 5-1 Summary of Direct Effect RQsa for the Aquatic-phase CRLF EEC Scenario CAForestryRLF (forest trees and Christmas tree plantations) CArowcropRLF 8 Rice model (Rice) Cagrapes_WirrigSTD, CAwinegrapesRLF (grapes) CAalmond_WirrigSTDh CATurfRLF J CAalfalfa_WirrigOP (alfalfa, lupine) Cafruit_WirrigSTD ' CAOliveRLF (olives) Cacitrus_WirrigSTD K CAcornOP (corn and sunflower) Peak EEC (Hg/L)" 16.6 11.9 48 11.4 11.7 11.5 11.3 11.2 11.2 11.1 6.8 d 60-day EEC (Hg/L) b 4.9 2.9 Not available 1.8 2.3 1.9 2.0 1.9 1.7 1.5 1.5 Acute RQ 0.12 0.09 0.35 0.08 0.08 0.08 0.08 0.08 0.08 0.08 0.05 Chronic RQ 0.8 e <1.0e Not applicable <1.0e <1.0e <1.0e <1.0e <1.0e <1.0e <1.0e <1.0e Probability of Individual Effect at ES LOC 4.18E+08 Probability of Individual Effect at RQ 1 in 5.85E+04 (1 in 30.5 tolinl.73E+16)c lin7.91E+05 (1 in 54.8 to 1 in 4.10E+20)C 1 in 49. 8 (1 in 5. 53 to 1 in 4.91E+04 )c lin2.51E+06 (1 in 70.8 tolin 3.64E+22 )c lin2.51E+06 (1 in 70.8 tolin 3.64E+22 )c lin2.51E+06 (1 in 70.8 tolin 3.64E+22 )c lin2.51E+06 (1 in 70.8 to 1 in 3.64E+22 )c lin2.51E+06 (1 in 70.8 to 1 in 3.64E+22 )c lin2.51E+06 (1 in 70.8 tolin 3.64E+22 )c lin2.51E+06 (1 in 70.8 tolin 3.64E+22 )c lin4.18E+08 (1 in 216 to 1 in 1.75E+31 )c a RQs associated with acute and chronic direct toxicity to the CRLF are also used to assess potential indirect effects to the CRLF based on a reduction in freshwater fish and frogs as food items. The toxicity value used as surrogate species is rainbow trout LC50 of 138 ppb (ug/L) and Fathead minnow NOAEC of 6.3 ppb (ug/L). b The highest EEC based on foliar use of pendimethalin on forestry at 4.0 Ib ai/A (see Table 3-3). 0 A probit slope value for the acute rainbow trout toxicity test is not available; therefore, the effect probability was calculated based on a default slope assumption of 4.5 with upper and lower 95% confidence intervals of 2 and 9 (Urban and Cook, 1986). Not calculated for chronic endpoints. d Peak EEC below 6.8 ppb will result in RQ < acute endangered species LOC of 0.05. e RQ< chronic LOC of 1.0. 8 This scenario represents artichoke, asparagus, beans, carrot (including tops), garbanzos (including chick peas), legume vegetables, peanuts (unspecified), peas, and pepper. h This scenario represents almond, beech nut, brazil nut, butternut, cashew, chestnut, chinquapin, filbert (hazelnut), hickory nut, macadamia nut (bushnut), mayhaw (hawthorn), pecan, pistachio, walnut (English or black) 1 This scenario represents apple, apricot, cherry, crabapple, fig, loquat, nectarine, peach, pear, pepino (melon pear), plum, pomegranate, prune, quince, and small fruits. J This scenario represents commercial/industrial lawns, golf course turf, ornamental lawns and turf, ornamental sod farm (turf), recreation area lawns, and residential lawns. 77 ------- K This scenario represents calamondin, citron (citrus), citrus hybrids other than tangelo, grapefruit, kumquat, lemon, lime, orange, pummelo (shaddock), and tangelo. 5.1.1.2 Indirect Effects to Aquatic-Phase CRLF via Reduction in Prey (non-vascular aquatic plants, aquatic invertebrates, fish, and frogs) a) Non-vascular Aquatic Plants Indirect effects of pendimethalin to the aquatic-phase CRLF (tadpoles) via reduction in non-vascular aquatic plants in its diet are based on peak EECs from the standard pond and the lowest toxicity value (ECso) for aquatic non-vascular plants. Based on exceedances of the acute LOG (1.0) for aquatic plants, pendimethalin is likely to indirectly affect the CRLF via reduction in non-vascular plants. The results of the RQ calculations are in Table 5.2 below. Table 5-2 Summary of RQs Used to Estimate Indirect Effects to the CRLF via Effects to Non-Vascular Aquatic Plants a (diet of CRLF in tadpole life stage and habitat of aquatic-phase CRLF) Uses Rice model (Rice) CAForestryRLF (forest trees and Christmas tree plantations) CArowcropRLF e CAalrnond_WirrigSTD' CATurfRLF h Cagrapes_WirrigSTD, CAwinegrapesRLF (grapes) CAalmond_WirrigSTD ' CAalfalfa_WirrigOP (alfalfa, lupine) Cafruit_WirrigSTD g CAOliveRLF (olives) Cacitrus_WirrigSTD ' CAcornOP (corn and sunflower) CAwheatRLF (sorghum and wheat) CAcotton_WirrigSTD (cotton) CAOnion_WirrigSTD (onion and shallot) Application rate (Ib ai/A) and type 1 Ib ai/A (aerial) 4 Ib ai/A (aerial) 4 Ib ai/A (aerial) 4 Ib ai/A (aerial) 4 Ib ai/A (aerial) 4 Ib ai/A (aerial) 6 Ib ai/A (ground) 4 Ib ai/A (aerial) 4 Ib ai/A (aerial) 4 Ib ai/A (aerial) 4 Ib ai/A (aerial) 2 Ib ai/A (aerial) 1.5 Ib ai/A (aerial) 2 Ib ai/A (aerial) 2 Ib ai/A (aerial) Peak EEC (Hg/L) 48 16.6 b 11.9 11.7 11.5 11.4 6.6 11.3 11.2 11.2 11.1 6.8 6.1 5.8 5.6 c Indirect effects RQ* (food and habitat) 9.2 3.2 2.3 2.3 2.2 2.2 1.3 2.2 2.2 2.2 2.1 1.3 1.2 1.1 1.1 * LOG exceedances (RQ > 1) are bolded and shaded. RQ = use-specific peak EEC/ marine diatom (Skeletonema costatum) ECso of 5.2 ppb. a The toxicity value used as surrogate species is marine diatom (Skeletonema costatum) EC50 of 5.2 ppb (ug/L). b The highest EEC based on foliar use of pendimethalin is on forestry at 4.0 Ib ai/A (see Table 3-3). c Peak EEC below 5.2 ppb will result in RQ < acute LOC of 1.0. 78 ------- e This scenario represents artichoke, asparagus, beans, carrot (including tops), garbanzos (including chick peas), legume vegetables, peanuts (unspecified), peas, and pepper. f This scenario represents almond, beech nut, brazil nut, butternut, cashew, chestnut, chinquapin, filbert (hazelnut), hickory nut, macadamia nut (bushnut), mayhaw (hawthorn), pecan, pistachio, walnut (English or black) 8 This scenario represents apple, apricot, cherry, crabapple, fig, loquat, nectarine, peach, pear, pepino (melon pear), plum, pomegranate, prune, quince, and small fruits. h This scenario represents commercial/industrial lawns, golf course turf, ornamental lawns and turf, ornamental sod farm (turf), recreation area lawns, and residential lawns. 1 This scenario represents calamondin, citron (citrus), citrus hybrids other than tangelo, grapefruit, kumquat, lemon, lime, orange, pummelo (shaddock), and tangelo. b) Aquatic Invertebrates Indirect acute effects to the aquatic-phase CRLF via effects to prey (invertebrates) in aquatic habitats are based on peak EECs in the standard pond and the lowest acute toxicity value for freshwater invertebrates. For chronic risks, 21-day EECs and the lowest chronic toxicity value for invertebrates are used to derive RQs. A summary of the acute and chronic RQ values for exposure to aquatic invertebrates (as prey items of aquatic- phase CRLFs) is provided in Table 5-3. Based on the acute LOG (0.5) and chronic LOG (1.0) not being exceeded, pendimethalin has no effect, indirectly on the CRLF based on effects to aquatic invertebrates. The table shows only the use sites that exceed the LOG plus the highest EEC that does not exceed the LOG. Table 5-3 Summary of Acute and Chronic RQsa Used to Estimate Indirect Effects to the CRLF via Direct Effects on Aquatic Invertebrates as Dietary Food Items (prey of CRLF juveniles and adults in aquatic habitats) EEC Scenario Rice model (Rice) CAForestryRLF (Forest trees and Christmas tree plantations) CArowcropRLF h ( artichoke/asparagus) Peak EEC (Jig/L)b 48 16.6 11.9 21-day EEC (Hg/L)b Not available 6.4 4.0 Acute RQ 0.17' 0.06 b 0.04' Chronic RQ Not applicable 0.4 e <1.0e Probability of Individual Effect at ES LOC Probability of Individual Effect at RQ 1 in 3,740 (1 in 16.2 to lin4.62E+ll)c lin5.22E+07(lin 138tolin5.04E+27)c Not applicable a RQs associated with acute and chronic direct toxicity to the CRLF are also used to assess potential indirect effects to the CRLF based on a reduction in freshwater fish and frogs as food items. The toxicity value used as surrogate species is Daphnia magna EC50 of 280 ppb (ug/L) and Daphnia magna NOAEC of 14.5 ppb (ug/L). b The highest EEC based on foliar use of pendimethalin on forestry and Christmas trees at 4.0 Ib ai/A (see Table 3-3). 0 A probit slope value for the acute Daphnia magna toxicity test is not available; therefore, the effect probability was calculated based on a default slope assumption of 4.5 with upper and lower 95% confidence intervals of 2 and 9 (Urban and Cook, 1986). Not calculated for chronic endpoints. d Peak EEC below 5.2 ppb will result in RQ < acute endangered species LOC of 0.05. e RQ< chronic LOC of 1.0. f RQ< acute LOC of 0.5. 79 ------- h This scenario represents artichoke, asparagus, beans, carrot (including tops), garbanzos (including chick peas), legume vegetables, peanuts (unspecified), peas, and pepper. c) Fish and Frogs Fish and frogs also represent potential prey items of adult aquatic-phase CRLFs. RQs associated with acute and chronic direct toxicity to the CRLF (Table 5.1) are used to assess potential indirect effects to the CRLF based on a reduction in freshwater fish and frogs as food items. Based on listed species LOG exceedances using the surrogate rainbow trout acute LCso toxicity endpoint and the fathead minnow chronic NOAEC endpoint, pendimethalin may indirectly affect the CRLF via reduction in freshwater fish and frogs as food items. 5.1.1.3 Indirect Effects to CRLF via Reduction in Habitat and/or Primary Productivity (Freshwater Aquatic Plants) Indirect effects to the CRLF via direct toxicity to aquatic plants are estimated using the most sensitive non-vascular and vascular plant toxicity endpoints. Because there are no obligate relationships between the CRLF and any aquatic plant species, the most sensitive ECso values, rather than NOAEC values, were used to derive RQs. Based on vascular aquatic plant LOG (1.0) exceedances, pendimethalin may indirectly affect the CRLF via reduction in vascular plants from uses on forestry and Christmas tree plantations and from rice use. Table 5-4 shows only the use sites that exceed the LOG plus the highest EEC that does not exceed the LOG. Table 5-4 Summary of RQs Used to Estimate Indirect Effects to the CRLF via Effects to Vascular Aquatic Plants (habitat of aquatic-phase CRLF)a Uses Rice model (Rice) CAForestryRLF (forest trees and Christmas tree plantations) Application rate (Ib ai/A) and type 1 Ib ai/A (aerial) 4 Ib ai/A (aerial) Peak EEC (Hg/L) 48 16.6 Indirect effects RQ* (food and habitat) 3.8 1.3 a RQs used to estimate indirect effects to the CRLF via toxicity to vascular aquatic plants are summarized in Table 5.2. The toxicity value used as surrogate species is duckweed (Lemna gibba) EC50 of 12.5 ppb (ug/L). b The highest EEC based on foliar use of pendimethalin on forestry at 4.0 Ib ai/A (see Table 3-3). c Peak EEC below 12.5 ppb will result in RQ < acute LOC of 1.0. * = LOC exceedances (RQ > 1) are bolded. RQ = use-specific peak EEC / duckweed EC50 of 12.5 ppb. 5.1.2 Exposures in the Terrestrial Habitat 5.1.2.1 Direct Effects to Terrestrial-phase CRLF 80 ------- Potential direct acute effects to the terrestrial-phase CRLF are derived by considering dose- and dietary-based EECs modeled in T-REX for a small bird (20 g) consuming small invertebrates (Table 3.5) and acute oral and subacute dietary toxicity endpoints for avian species. Potential direct chronic effects of pendimethalin to the terrestrial-phase CRLF are derived by considering dietary-based exposures modeled in T-REX for a small bird (20g) consuming small invertebrates. Chronic effects are estimated using the lowest available toxicity data for birds. EECs are divided by toxicity values to estimate chronic dietary- based RQs. Based on RQ exceedances of listed species acute LOG (0.1) and chronic LOG (1.0) from all use sites, pendimethalin may directly affect the terrestrial-phase of the CRLF. Table 5-5 Summary of Acute RQs* Used to Estimate Direct Effects to the Terrestrial-phase CRLF Use Site walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of- way, fencerows, hedgerows, mulch, industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa Asparagus, artichoke golf course turf, airports/landing fields residential lawns Shallot, onion, com (sweet, pop, field) Carrot Sunflower Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, Application rate (Ibs ai/A) 6.0 4.0 3.9 3.5 3.0 2.0 1.9 1.73 1.485 Dietary-based Acute RQ1 0.2 0.1 0.1 0.1 0.1 <0.1 <0.1 <0.1 <0.1 Dose- based Acute RQ1 1.25 0.8 0.8 0.7 0.6 0.4 0.4 0.4 0.3 Probability of Individual Effect at RQ Dose-based: 1 in 1.5(1 in 1.73 to 1 in 1.24 )2 Dietary-based: 1 in 1.5(1 in 1.73 to 1 in 1.24 )2 Dose-based: 1 in 3.02 (1 in 2. 36 to 1 in 5.22 )2 Dietary-based: 1 in 2.94E+05 (1 in 44 to 8.86E+18)2 Dose-based: 1 in 3.02 (1 in 2. 36 to 1 in 5.22 )2 Dietary-based: 1 in 2.94E+05 (1 in 44 to 8.86E+18)2 Dose-based: 1 in 4. 12 (1 in 2. 64 to 1 in 12.2 )2 Dietary-based: 1 in 2.94E+05 (1 in 44 to 8.86E+18)2 Dose-based: 1 in 1.5(1 in 1.73 to 1 in 1.24 )2 Dietary-based: 1 in 2.94E+05 (1 in 44 to 8.86E+18)2 Dose-based: 1 in 27.3 (1 in 4.69 to 1 in 5.85E+03)2 Dietary-based: n/a Dose-based: 1 in 27.3 (1 in 4.69 to 1 in 5.85E+03)2 Dietary-based: n/a Dose-based: 1 in 27.3 (1 in 4.69 to 1 in 5.85E+03)2 Dietary-based: n/a Dose-based: 1 in 107 (1 in 6.76 to 7.91E+05)2 Dietary-based: n/a 81 ------- Use Site cowpea (southern pea, black-eyed bean), Wheat, pepper, pepino (melon pear), groundcherry, eggplant Strawberry Legume vegetables Rice, mustard cabbage (gai choy, pak-choi), kohlrabi, cauliflower, cabbage (Chinese), cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables * = LOG exceedances (acute RQ > 0. 1) are bolded and sh< 1 Based on mallard LD50 of 1421 mg/kg-bw and bobwhite 2 A probit slope value for the acute mallard duck and bobwhite default slope assumption of 4.5 with upper and lower 95% confi Application rate (Ibs ai/A) 1.425 1.485(2 applications w/ 30-day interval) 1.24 1.0 Dietary-based Acute RQ1 <0.1 <0.1 0.1 <0.1 Dose- based Acute RQ1 0.3 0.5 0.3 0.2 Probability of Individual Effect at RQ Dose-based: 1 in 107 (1 in 6.76 to 7.91E+05)2 Dietary-based: n/a Dose-based: 1 in 15. 5(1 in 4 to 1 in 832)2 Dietary-based: n/a Dose-based: 1 in 107 (1 in 6.76 to 7.91E+05)2 Dietary-based: n/a Dose-based: 1.21E+03 (1 in 12.3 to 6.33E+09)2 Dietary-based: n/a ided. ;LC50of4187ppm. }uail toxicity test is not available; therefore, the effect probability was calculated based on a ience intervals of 2 and 9 (Urban and Cook, 1986). Not calculated for chronic endpoints. Table 5-6 Summary of Chronic RQs* Used to Estimate Direct Effects to the Terrestrial-phase CRLF Use Site walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of-way, fencerows, hedgerows, mulch, industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa Asparagus, artichoke golf course turf, airports/landing fields residential lawns Shallot, onion, corn (sweet, pop, field) Carrot Sunflower Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, cowpea (southern pea, black-eyed bean), Wheat, pepper, pepino (melon pear), groundcherry, eggplant Application rate (Ibs ai/A) 6.0 4.0 3.9 3.5 3.0 2.0 1.9 1.73 1.485 1.425 Dietary-based Chronic RQ1 5.7 3.8 3.7 3.35 2.9 1.9 1.8 1.7 1.4 1.4 82 ------- Use Site Strawberry Legume vegetables Rice, mustard cabbage (gai choy, pak-choi), kohlrabi, cauliflower, cabbage (Chinese), cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables Application rate (Ibs ai/A) 1.485 (2 applications w/ 30- day interval) 1.24 1.0 Dietary-based Chronic RQ1 2.1 1.2 1.0 * = LOG exceedances (chronic RQ > 1) are bolded and shaded. 1 Based on bobwhite NOAEC of 141 ppm. 5.1.2.2 Indirect Effects to Terrestrial-Phase CRLF via Reduction in Prey (terrestrial invertebrates, mammals, and frogs) 5.1.2.2.1 Terrestrial Invertebrates In order to assess the risks of pendimethalin to terrestrial invertebrates, which are considered prey of CRLF in terrestrial habitats, the honey bee is used as a surrogate for terrestrial invertebrates. The toxicity value for terrestrial invertebrates is calculated by multiplying the lowest available acute contact LD50 of greater than 49.8 jig a.i./bee by 1 bee/0.128g, which is based on the weight of an adult honey bee. EECs (jig a.i./g of bee) calculated by T-REX for small and large insects are divided by the calculated toxicity value for terrestrial invertebrates, which is >388.4 jig a.i./g of bee. Based on RQ ranges from 2.09 to 0.05, pendimethalin may indirectly affect the CRLF via reduction in terrestrial invertebrate prey items Table 5-7 Summary of RQs Used to Estimate Indirect Effects phase CRLF via Direct Effects on Terrestrial Invertebrates as to the Terrestrial- Dietary Food Items Use walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. (6.0 Ib ai/A) Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of-way, fencerows, hedgerows, mulch, industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa (4.0 Ib ai/A) Asparagus, artichoke (3.9 Ib ai/A) Small Insect RQ* 2.09 1.39 1.36 Large Insect RQ* 0.23 0.15 0.15 Probability of Individual Effect at RQ of Small Insect 1 in 1.08(1 in 1.35 to 1 in 1.0 )a 1 in 1.35(1 in 1.11 to 1 in 1.63 )a 1 in 1.38(1 in 1.13 to 1 in 1.65)a 83 ------- golf course turf, airports/landing fields (3.5 Ib ai/A) residential lawns (3.0 Ib ai/A) Shallot, onion, com (sweet, pop, field) (2.0 Ib ai/A) Carrot (1.91bai/A) Sunflower (1. 73 Ib ai/A) Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, cowpea (southern pea, black-eyed bean), (1.485 Ib ai/A) Wheat, pepper, pepino (melon pear), groundcherry, eggplant (1. 425 Ib ai/A) Strawberry (1 .485 Ib ai/A (2 applications w/ 30- day interval)) Legume vegetables (0.124 Ib ai/A) Rice, mustard cabbage (gai choy, pak-choi), kohlrabi, cauliflower, cabbage (Chinese), cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables (l.Olbai/A) 1.22 1.04 0.70 0.66 0.60 0.51 0.49 0.88 0.43 0.35 0.14 0.12 0.08 0.07 0.07 0.06 0.05 0.10 0.05 0.04 1 in 1.54(1 in 1.28 to 1 in 1.76)a 1 in 1.88(1 in 1.78 to 1 in 1.95)a 1 in 4. 12(1 in 2.64 to 1 in 12.2)a 1 in 4. 8(1 in 2.78 to 1 in 19.2)a 1 in 6.29(1 in 3. 04 to 1 in43.6)a 1 in 10.6(1 in 3. 58 to 1 in236)a 1 in 12.2(1 in 3.73 to 1 in 377)a 1 in 249(1 in 2. 19 to 1 in3.24)a 1 in 20.2(1 in 4.31 to 1 in2,060)a 1 in 49.8(1 in 5.53 to 1 in4.91E+04)a * = LOG exceedances (RQ > 0.05) are bolded and shaded. Because a definitive endpoint was not established for terrestrial invertebrates (i.e., the value is greater than the highest test concentration), the RQ represents an upper bound value. a A probit slope value for the acute honey bee toxicity test is not available; therefore, the effect probability was calculated based on a default slope assumption of 4.5 with upper and lower 95% confidence intervals of 2 and 9 (Urban and Cook, 1986). Probability of Individual Effect at RQ of 0.05 is 1 in4.18E+08 (1 in 216 to 1 in 1.75E+31). 5.1.2.2.2 Mammals Risks associated with ingestion of small mammals by large terrestrial-phase CRLFs are derived for dietary-based and dose-based exposures modeled in T-REX for a small mammal (15g) consuming short grass. Acute and chronic effects are estimated using the most sensitive mammalian toxicity data. EECs are divided by the toxicity value to estimate acute and chronic dose-based RQs as well as chronic dietary-based RQs. Based on RQ ranges from 25.0 to 6.2 for chronic effects, pendimethalin is likely to indirectly affect the CRLF via reduction in small mammal prey items. 84 ------- Table 5-8 Summary of Acute and Chronic RQs* Used to Estimate Indirect Effects to the Terrestrial-phase CRLF via Direct Effects on Small Mammals as Dietary Food Items Use (Application Rate) walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. (6.0 Ib ai/A) Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of-way, fencerows, hedgerows, mulch, industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa (4.0 Ib ai/A) Asparagus, artichoke (3.9 Ib ai/A) golf course turf, airports/landing fields (3.5 Ib ai/A) residential lawns (3.0 Ib ai/A) Shallot, onion, corn (sweet, pop, field) (2.0 Ib ai/A) Carrot (1.91bai/A) Sunflower (1. 73 Ib ai/A) Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, cowpea (southern pea, black-eyed bean), (1 .485 Ib ai/A) Wheat, pepper, pepino (melon pear), groundcherry, eggplant (1. 425 Ib ai/A) Strawberry (1.485 Ib ai/A (2 applications w/ 30- day interval)) Legume vegetables (0.124 Ib ai/A) Rice, mustard cabbage (gai choy, pak-choi), kohlrabi, cauliflower, cabbage (Chinese), Chronic RQ Dose- based Chronic RQ1 25.0 16.7 16.2 14.6 12.5 8.3 7.9 7.2 6.2 5.9 9.3 5.2 4.2 Dietary- based Chronic RQ2 2.9 1.9 1.9 1.7 1.4 1.0 0.9 0.8 0.7 0.7 1.1 0.6 0.5 Acute RQ Dose- based Acute RQ3 0.6 0.4 0.4 0.35 0.3 0.2 0.2 0.2 0.2 0.1 0.2 0.1 0.1 Probability of Individual Effect at RQ Dose-based: 1 in 6.29 (1 in 1.73 to 1 in 1. 24 )2 Dose-based: 1 in 27.3 (1 in 4.69 to 1 in 5.85E+03)2 Dose-based: 1 in 27.3 (1 in 4.69 to 1 in 5.85E+03)2 Dose-based: 1 in 49.8(1 in 5. 53 to 1 in 4.91E+04)2 Dose-based: 1 in 107(1 in 6.76 to 1 in 7.91E+05)2 Dose-based: 1 in 1.21E+03 (1 in 12.3 to 1 in6.33E+09)2 Dose-based: 1 in 1.21E+03 (1 in 12.3 to 1 in6.33E+09)2 Dose-based: 1 in 1.21E+03 (1 in 12.3 to 1 in6.33E+09)2 Dose-based: 1 in 1.21E+03 (1 in 12.3 to 1 in6.33E+09)2 1 in 2.94E+05 (1 in 44 to 1 in 8.86E+18)2 Dose-based: 1 in 1.21E+03 (1 in 12.3 to 1 in6.33E+09)2 lin2.94E+05(lin44to 1 in 8.86E+18)2 lin2.94E+05(lin44to 1 in 8.86E+18)2 85 ------- cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables (l.Olbai/A) Chronic RQ Acute RQ * = LOG exceedances (acute RQ > 0.1 and chronic RQ > 1) are bolded and shaded. 1 Based on dose-based EEC and pendimethalin rat NOAEL = 25 mg/kg-diet/day (500 ppm). 2 Based on dietary -based EEC and pendimethalin rat NOAEC = 25 mg/kg-diet/day (500 ppm). Based on dose-based EEC and pendimethalin rat acute oral LD50 = 1050 mg/kg-bw. 5.1.2.2.3 Frogs An additional prey item of the adult terrestrial-phase CRLF is other species of frogs. In order to assess risks to these organisms, dietary-based and dose-based exposures modeled in T-REX for a small bird (20g) consuming small invertebrates are used. See Section 5.1.2.1 and associated tables (Table 5-65 and 5.6) for results. Based on dose-based acute RQs the range from 1.25 to 0.2 and chronic RQs that range from 5.7 to 1.0, pendimethalin may indirectly affect the CRLF via reduction in frogs as prey items. 5.1.2.3 Indirect Effects to CRLF via Reduction in Terrestrial Plant Community (Riparian and Upland Habitat) Potential indirect effects to the CRLF resulting from direct effects on riparian and upland vegetation are assessed using RQs from terrestrial plant seedling emergence and vegetative vigor EC25 data as a screen. Based on LOG exceedances from all use sites, pendimethalin may indirectly affect the CRLF via reduction in terrestrial plants. Example output from TerrPlant v. 1.2.2 is provided in Appendix F. Table 5-9 RQs* for Monocots Inhabiting Dry and Semi-Aquatic Areas Exposed to Pendimethalin via Runoff and Drift Use walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of-way, fencerows, hedgerows, mulch, Application rate (Ibs a.i./A) 6.0 Ib ai/A 4.0 Ib ai/A Application method ground ground Drift Value (%) 1 1 Spray drift RQ 6.0 4.0 Dry area RQ 12.0 8.0 Semi-aquatic area RQ 66.0 44.0 86 ------- Use industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa Asparagus, artichoke golf course turf, airports/landing fields residential lawns Shallot, onion, com (sweet, pop, field) Carrot Sunflower Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, cowpea (southern pea, black-eyed bean) Wheat, pepper, pepino (melon pear), groundcherry, eggplant, strawberry Legume vegetables Rice, mustard cabbage (gai choy, pak- choi), kohlrabi, cauliflower, cabbage (Chinese), cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables Application rate (Ibs a.i./A) 3.91bai/A 3.51bai/A 3.01bai/A 2.0 Ib ai/A 1.91bai/A 1.731bai/A 1.485 Ib ai/A 1.425 Ib ai/A 1.241bai/A l.Olbai/A Application method aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial Drift Value (%) 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 Spray drift RQ 20.0 3.9 19.5 3.5 17.5 3.0 15.0 2.0 10.0 1.9 9.5 1.7 8.7 1.5 7.4 1.4 7.12 1.2 6.2 1.0 5.0 Dry area RQ 24.0 7.8 23.4 7.0 21.0 6.00 18.0 4.0 12.0 3.8 11.4 3.5 10.4 3.0 8.9 2.9 8.6 2.5 7.4 2.0 6.0 Semi-aquatic area RQ 60.0 42.9 58.5 38.5 52.5 33.0 43.0 22.0 30.0 20.9 28.5 19.0 26.0 16.3 22.3 15.7 21.4 13.6 18.6 11.0 15.0 * = LOG exceedances (RQ > 1) are bolded and shaded. Table 5-10 RQs* for Dicots Inhabiting Dry and Semi-Aquatic Areas Exposed to Pendimethalin via Runoff and Drift Use walnut (english/black), tangerines, tangelo, small fruits, pummelo (shaddock), pomegranate, pistachio, pecan, orange, macadamia nut (bushnut), lime, lemon, kumquat, hickory nut, grapefruit, filbert (hazelnut), citrus hybrids other than tangelo, citron (citrus), chinquapin, chestnut, cashew, calamondin, butternut, brazil nut, beech nut, almond, grapes. Application rate (Ibs a.i./A) 6.0 Ib ai/A Application method ground Drift Value (%) 1 Spray drift RQ 0.7 Dry area RQ 1.3 Semi-aquatic area RQ 7.3 87 ------- Use Prune, plum, pear, peach, olive, nectarine, fig, cherry, apricot, apple, ornamental and/or shade trees, nonagricultural rights-of-way, fencerows, hedgerows, mulch, industrial areas (outdoor), forest trees (all or unspecified), Christmas tree plantations, recreation area lawns, loquat, shelterbelt plantings, quince, mayhaw, crabapple, alfalfa Asparagus, artichoke golf course turf, airports/landing fields residential lawns Shallot, onion, com (sweet, pop, field) Carrot Sunflower Tomato, tomatillo, tobacco, sorghum, potato (white/Irish), lupine (grain), garlic, garbanzos (including chick peas) beans, succulent (snap or lima) beans, dried-type beans, cotton, cowpea (southern pea, black-eyed bean) Wheat, pepper, pepino (melon pear), groundcherry, eggplant, strawberry Legume vegetables Rice, mustard cabbage (gai choy, pak- choi), kohlrabi, cauliflower, cabbage (Chinese), cabbage, brussels sprouts, broccoli (Chinese), broccoli, Brassica (head and stem) vegetables Application rate (Ibs a.i./A) 4.0 Ib ai/A 3.91bai/A 3. 5 Ib ai/A 3.01bai/A 2.0 Ib ai/A 1.91bai/A 1.731bai/A 1.485 Ib ai/A 1.425 Ib ai/A 1.241bai/A l.Olbai/A Application method ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial ground aerial Drift Value (%) 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 Spray drift RQ 0.4 2.2 0.4 2.2 0.4 1.9 0.3 1.7 0.2 1.1 0.2 1.1 0.2 1.0 0.2 0.8 0.2 0.8 0.1 0.7 0.1 0.6 Dry area RQ 0.9 2.7 0.9 2.6 0.8 2.3 0.7 2.0 0.4 1.3 0.4 1.3 0.4 1.2 0.3 1.0 0.3 1.0 0.3 0.8 0.2 0.7 Semi-aquatic area RQ 5.9 6.7 4.8 6.5 4.3 5.8 3.7 5.0 2.4 3.3 2.3 3.2 2.1 2.9 1.8 2.5 1.7 2.4 1.5 2.1 1.2 1.7 * = LOG exceedances (RQ > 1) are bolded and shaded. 5.1.3 Primary Constituent Elements of Designated Critical Habitat 5.1.3.1 Aquatic-Phase (Aquatic Breeding Habitat and Aquatic Non- Breeding Habitat) Three of the four assessment endpoints for the aquatic-phase primary constituent elements (PCEs) of designated critical habitat for the CRLF are related to potential effects to aquatic and/or terrestrial plants: 88 ------- • Alteration of channel/pond morphology or geometry and/or increase in sediment deposition within the stream channel or pond: aquatic habitat (including riparian vegetation) provides for shelter, foraging, predator avoidance, and aquatic dispersal for juvenile and adult CRLFs. • Alteration in water chemistry/quality including temperature, turbidity, and oxygen content necessary for normal growth and viability of juvenile and adult CRLFs and their food source. • Reduction and/or modification of aquatic-based food sources for pre-metamorphs (e.g., algae). Based on the risk estimation for potential effects to aquatic and/or terrestrial plants provided in Sections 5.1.1.2, 5.1.1.3, and 5.1.2.3, pendimethalin may affect aquatic-phase PCEs of designated habitat related to effects on aquatic and/or terrestrial plants. The remaining aquatic-phase PCE is "alteration of other chemical characteristics necessary for normal growth and viability of CRLFs and their food source." To assess the impact of pendimethalin on this PCE (i.e., alteration of food sources), acute and chronic freshwater fish and invertebrate toxicity endpoints, as well as endpoints for aquatic non-vascular plants, are used as measures of effects. RQs for these endpoints were calculated in Sections 5.1.1.1 and 5.1.1.2. Based on RQ exceedances of LOG, pendimethalin may affect aquatic-phase PCEs of designated habitat related to effects of alteration of other chemical characteristics necessary for normal growth and viability of CRLFs and their food source. 5.1.3.2 Terrestrial-Phase (Upland Habitat and Dispersal Habitat) The first two assessment endpoints for the terrestrial-phase PCEs of designated critical habitat for the CRLF are related to potential effects to terrestrial plants: • Elimination and/or disturbance of upland habitat; ability of habitat to support food source of CRLFs: Upland areas within 200 ft of the edge of the riparian vegetation or dripline surrounding aquatic and riparian habitat that are comprised of grasslands, woodlands, and/or wetland/riparian plant species that provides the CRLF shelter, forage, and predator avoidance • Elimination and/or disturbance of dispersal habitat: Upland or riparian dispersal habitat within designated units and between occupied locations within 0.7 mi of each other that allow for movement between sites including both natural and altered sites which do not contain barriers to dispersal The risk estimation for terrestrial-phase PCEs of designated habitat related to potential effects on terrestrial plants is provided in Section 5.1.2.3. Based on exceedances of LOG for non-target terrestrial plants, all use sites of pendimethalin may affect the first and second terrestrial - phase PCEs. 89 ------- The third terrestrial-phase PCE is "reduction and/or modification of food sources for terrestrial phase juveniles and adults." To assess the impact of pendimethalin on this PCE, acute and chronic toxicity endpoints for birds, mammals, and terrestrial invertebrates are used as measures of effects. RQs for these endpoints were calculated in Section 5.1.2.3. Based on RQ exceedances of LOG from all use sites, pendimethalin may affect the third terrestrial - phase PCE. The fourth terrestrial-phase PC is based on alteration of chemical characteristics necessary for normal growth and viability of juvenile and adult CRLFs and their food source. Direct acute and chronic RQs for terrestrial-phase CRLFs are presented in Section 5.1.2.1. Based on RQ exceedances of LOG from all use sites, pendimethalin may affect the forth terrestrial - phase PCE. 5.2 Risk Description The risk description synthesizes an overall conclusion regarding the likelihood of adverse impacts leading to an effects determination (i.e., "no effect," "may affect, but not likely to adversely affect," or "likely to adversely affect") for the CRLF and its designated critical habitat. Based on the RQs presented in the Risk Estimation (Section 5.1) a preliminary effects determination is "may affect" for the CRLF and critical habitat. The direct or indirect effect LOCs are exceeded and effects may modify the PCEs of the CRLF's critical habitat, the Agency concludes a preliminary "may affect" determination for the FIFRA regulatory action regarding pendimethalin. A summary of the results of the risk estimation results are provided in Error! Not a valid bookmark self- reference. 1 for direct and indirect effects to the CRLF and in Table 5-122 for the PCEs of designated critical habitat for the CRLF. Table 5-11 Risk Estimation Summary for Pendimethalin - Direct and Indirect Effects to CRLF Assessment Endpoint LOC Exceedances (Y/N) Description of Results of Risk Estimation Aquatic Phase (eggs, larvae, tadpoles, juveniles, and adults) Direct Effects Survival, growth, and reproduction of CRLF individuals via direct effects on aquatic phases Indirect Effects Survival, growth, and reproduction of CRLF individuals via effects to food supply (i.e., freshwater invertebrates, non-vascular plants) Indirect Effects Survival, growth, and reproduction Yes Yes Yes There are acute LOC exceedances for fish, aquatic -phase CRLF. the surrogate for the There are LOC exceedances for non-target aquatic non-vascular plants. There are no acute and chronic LOC exceedances for aquatic invertebrates. There are exceedances of the LOC for both vascular and non- vascular aquatic plants. 90 ------- Assessment Endpoint of CRLF individuals via effects on habitat, cover, and/or primary productivity (i.e., aquatic plant community) Indirect Effects Survival, growth, and reproduction of CRLF individuals via effects to riparian vegetation, required to maintain acceptable water quality and habitat in ponds and streams comprising the species' current range. LOC Exceedances (Y/N) Yes Description of Results of Risk Estimation There are LOC exceedances for non-target aquatic vascular and terrestrial plants. Effects are possible for riparian vegetation. Terrestrial Phase (Juveniles and adults) Direct Effects Survival, growth, and reproduction of CRLF individuals via direct effects on terrestrial phase adults and juveniles Indirect Effects Survival, growth, and reproduction of CRLF individuals via effects on prey (i.e., terrestrial invertebrates, small terrestrial mammals and terrestrial phase amphibians) Indirect Effects Survival, growth, and reproduction of CRLF individuals via effects on habitat (i.e., riparian vegetation) Yes Yes Yes There are acute and chronic LOC exceedances to birds, the surrogate for the terrestrial-phase CRLF. There are acute and chronic LOC exceedances to birds, the surrogate for the terrestrial-phase amphibians. There are LOC exceedances (>0.05) for terrestrial invertebrates. There are acute and chronic LOC exceedances for small mammals. There are LOC exceedances for non-target aquatic vascular and terrestrial plants. Effects are possible for riparian vegetation. Table 5-12 Risk Estimation Summary for Pendimethalin - PCEs of Designated Critical Habitat for the CRLF Assessment Endpoint Habitat Effects (Y/N) Description of Results of Risk Estimation Aquatic Phase PCEs (Aquatic Breeding Habitat and Aquatic Non-Breeding Habitat) Alteration of channel/pond morphology or geometry and/or increase in sediment deposition within the stream channel or pond: aquatic habitat (including riparian vegetation) provides for shelter, foraging, predator avoidance, and aquatic dispersal for juvenile and adult CRLFs. Yes There are LOC exceedances for non-target aquatic vascular and terrestrial plants. Effects are possible to non-target terrestrial and aquatic vascular plants inhabiting riparian areas. 91 ------- Assessment Endpoint Alteration in water chemistry /quality including temperature, turbidity, and oxygen content necessary for normal growth and viability of juvenile and adult CRLFs and their food source. Alteration of other chemical characteristics necessary for normal growth and viability of CRLFs and their food source. Reduction and/or modification of aquatic- based food sources for pre-metamorphs (e.g., algae) Habitat Effects (Y/N) Yes Yes Yes Description of Results of Risk Estimation There are LOG exceedances for non-target aquatic vascular and terrestrial plants. Alteration in water chemistry /quality is possible due to effects on aquatic/terrestrial plant communities in riparian areas. Due to potential effects on non-target aquatic plants and terrestrial riparian plant species, alteration in chemical characteristics of aquatic habitat (e.g. dissolved oxygen) may occur. There are LOG exceedances for non-vascular aquatic plants (i.e. algae). Terrestrial Phase PCEs (Upland Habitat and Dispersal Habitat) Elimination and/or disturbance of upland habitat; ability of habitat to support food source of CRLFs: Upland areas within 200 ft of the edge of the riparian vegetation or dripline surrounding aquatic and riparian habitat that are comprised of grasslands, woodlands, and/or wetland/riparian plant species that provides the CRLF shelter, forage, and predator avoidance Elimination and/or disturbance of dispersal habitat: Upland or riparian dispersal habitat within designated units and between occupied locations within 0.7 mi of each other that allow for movement between sites including both natural and altered sites which do not contain barriers to dispersal Reduction and/or modification of food sources for terrestrial phase juveniles and adults Alteration of chemical characteristics necessary for normal growth and viability of juvenile and adult CRLFs and their food source. Yes Yes Yes Yes There are LOG exceedances for non-target terrestrial plants. There are LOG exceedances for non-target terrestrial plants. These effects may alter plant communities necessary for dispersal habitat. Acute and chronic effects are possible on amphibians and mammal that serve as prey for CRLFs Changes in aquatic vegetation and riparian communities may alter the chemical characteristic of CRLF habitat Following a "may affect" determination, additional information is considered to refine the potential for exposure at the predicted levels based on the life history characteristics (i.e., habitat range, feeding preferences, etc.) of the CRLF. Based on the best available information, the Agency uses the refined evaluation to distinguish those actions that "may affect, but are not likely to adversely affect" from those actions that are "likely to adversely affect" the CRLF and its designated critical habitat. The criteria used to make determinations that the effects of an action are "not likely to adversely affect" the CRLF and its designated critical habitat include the following: 92 ------- • Significance of Effect: Insignificant effects are those that cannot be meaningfully measured, detected, or evaluated in the context of a level of effect where "take" occurs for even a single individual. "Take" in this context means to harass or harm, defined as the following: • Harm includes significant habitat modification or degradation that results in death or injury to listed species by significantly impairing behavioral patterns such as breeding, feeding, or sheltering. • Harass is defined as actions that create the likelihood of injury to listed species to such an extent as to significantly disrupt normal behavior patterns which include, but are not limited to, breeding, feeding, or sheltering. • Likelihood of the Effect Occurring: Discountable effects are those that are extremely unlikely to occur. • Adverse Nature of Effect: Effects that are wholly beneficial without any adverse effects are not considered adverse. A description of the risk and effects determination for each of the established assessment endpoints for the CRLF and its designated critical habitat is provided in Sections 5.2.1 through 5.2.4. 5.2.1 Direct Effects 5.2.1.1 Aquatic-Phase CRLF The aquatic-phase considers life stages of the frog that are obligatory aquatic organisms, including eggs and larvae. It also considers submerged terrestrial-phase juveniles and adults, which spend a portion of their time in water bodies that may receive runoff and spray drift containing pendimethalin. This assessment used the most sensitive acute and chronic toxicity values across fish species tested since there was no amphibian data available. RQs were based on acute studies in rainbow trout (LC50 = 138 ug/L, MRID 00046291) and a chronic NOAEC in fathead minnow (NOAEC = 6.3 ug/L, MRID 00037940). The highest acute RQ was 0.12 which exceeds the Agency's listed species acute LOG of 0.05. Based on a default probit slope value of 4.5 for the rainbow trout with 95% confidence intervals of 2 to 9, the associated probability of an individual effect would be approximately 1 in 5.85E+04. The most sensitive chronic toxicity value is based on a life cycle study in fathead minnow. The chronic RQ (0.8) was based on a NOAEC of 6.3 ug/L which does not exceed the Agency's chronic LOG of 1.0. The NOAEC is from an acceptable life-cycle fathead minnow study (MRID 00024377). Most sensitive endpoint was reduction in egg production that was observed at LOAEC of 44 ug/L 93 ------- Eleven aquatic EEC scenarios when compared to the acute toxicity for fish as a surrogate for aquatic-phase CRLF have acute RQs that exceeded the listed species LOG (0.05). None of the use sites has exceeded the chronic LOG for the CRLF. For the scenarios that exceeded the acute LOG for listed species, the probability of individual effect at acute RQ ranges from 1 in 5.85E+04 to 1 in 2.51E+06. The acute and chronic RQs are presented in Section 5.1.1.1. Direct effects to the aquatic-phase CRLF are based on peak EECs in the standard pond and the lowest acute toxicity value for freshwater fish. In order to assess direct chronic risks to the CRLF, 60-day EECs and the lowest chronic toxicity value for freshwater fish are used. Based on exceedances of the acute LOG for listed species (0.05), pendimethalin is likely to directly affect the aquatic-phase of the CRLF (LAA). Incident data provided to the Agency indicate that there are two alleged fish kill incidents that involve pendimethalin. However, these incidents do not show that pendimethalin registered use contributed to the alleged fish kill incidents. One of the alleged incidents is a spill in which an up to an estimated 300 gallons of undiluted Prowl was spilled into a creek. Another alleged incident involved pendimethalin applied as part of a mixture with Chlorpyrifos, which is highly toxic to fish. Further information on the pendimethalin incidents are provided in Appendix H. Monitoring data indicate that EECs modeled in PRZM-EXAMS are conservative. The highest detected pendimethalin is 0.679 ppb in San Joaquin-Tulare River Basin. The peak EECs range from 16.6 ppb to 6.8 ppb for those scenarios that exceed the listed species acute LOG (0.05). Based on the acute listed species LOG exceedances for CRLF and the widespread use sites that exceed the acute listed species LOG, pendimethalin is Likely to Adversely Affect (LAA) the aquatic-phase CRLF directly. 5.2.1.2 Terrestrial-Phase CRLF Acute and chronic LOCs were exceeded for birds (surrogate for terrestrial-phase CRLF). Dose-based acute RQs ranged from 1.25 (6.0 Ib ai/A application rate) to 0.2 (1.0 Ib ai/A application rate). Dietary-based acute RQs ranged from 0.2 (6.0 Ib ai/A application rate) to <0.1 (less than 2 Ib ai/A application rate). The RQs that exceed the endangered species LOG (0.1) are associated with a probability of an individual effect of approximately 1 in 1.5 to 1.21E+03 based on a default probit slope of 4.5. Avian chronic RQs ranged from 1.0 (1 Ib ai/A) to 5.7 (6.0 Ib ai/A). No treatment related effects were observed in the bobwhite quail and the LOAEL is greater than 1410 ppm. The mallard duck study (MRID 44907601) showed the parameter of 14-day survivor bodyweight was reduced at 1410 ppm (LOAEL). The NOAEL for the mallard study is 410 ppm. No other treatment related effects were observed. Avian body weight reduction may not necessary be a good parameter to measure effects to frog due to different physiological and caloric requirements. Therefore it is uncertain as to whether 94 ------- there is a potential chronic risk to CRLF. Since the chronic LOG is exceeded for birds which are surrogates for CRLF, chronic risk can not be precluded to CRLF. Therefore, the direct effects determination from chronic effects to CRLF is LAA. Birds were used as surrogate species for terrestrial phase CRLFs. Terrestrial phase amphibians are poikilotherms, which mean that their body temperature varies with environmental temperature; while birds are homeotherms (temperature is regulated, constant, and largely independent of environmental temperatures). As a consequence, the caloric requirements of terrestrial phase amphibians are markedly lower than birds. Therefore, on a daily dietary intake basis, birds consume more food than terrestrial phase amphibians. This can be seen when comparing the caloric requirements for free living iguanid lizards (used in this case as a surrogate for terrestrial phase amphibians) to song birds (U.S. EPA, 1993): iguanid FMR (kcal/day)= 0.0535 (bw g)°7" passerine FMR (kcal/day) = 2.123 (bw g)0749 With relatively comparable slopes to the allometric functions, one can see that, given a comparable body weight, the free living metabolic rate (FMR) of birds can be 40 times higher than reptiles, though the requirement differences narrow with high body weights. Because the existing risk assessment process is driven by the dietary route of exposure, a finding of safety for birds, with their much higher feeding rates and, therefore, higher potential dietary exposure is reasoned to be protective of terrestrial phase amphibians. For this not to be the case, terrestrial phase amphibians would have to be 40 times more sensitive than birds for the differences in dietary uptake to be negated. However, existing dietary toxicity studies in amphibians are lacking. To quantify the potential differences in food intake between birds and terrestrial phase CRLF, food intake equations for the iguanid lizard replaced the food intake equation in T-REX for birds, and additional food items of the CRLF were evaluated. These functions were encompassed in a model called T-HERPS. T-HERPS is available at: http://www.epa.gov/oppefedl/models/terrestrial/index.htm. Results of this analysis are presented in Table 5.13 (use pattern (1.0 Ib ai/A) with lowest EECs and RQs) through Table 5.16 (use pattern (6.0 Ib ai/A) with highest EECs and RQs). 95 ------- Table 5-13 Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (1 Ibs a.i./acre, 1 application) Size Class (grams) 1.4 37 238 Adjusted LD50 1421.00 1421.00 1421.00 EECs and RQs Broadleaf Plants/ Small Insects EEC 5.24 5.15 3.38 RQ 0.00 0.00 0.00 Fruits/Pods/ Seeds/ Large Insects EEC 0.58 0.57 0.38 RQ 0.00 0.00 0.00 Small Herbivore Mammals EEC N/A 92.77 14.42 RQ N/A 0.07 0.01 Small Insectivore Mammal EEC N/A 5.80 0.90 RQ N/A 0.00 0.00 Small Amphibians EEC N/A 0.18 0.12 RQ N/A 0.00 0.00 Table 5-14 Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (1.24 Ibs a.i./acre, 1 application) Size Class (grams) 1.4 37 238 Adjusted LD50 1421.00 1421.00 1421.00 EECs and RQs Broadleaf Plants/ Small Insects EEC 6.50 6.39 4.19 RQ 0.00 0.00 0.00 Fruits/Pods/ Seeds/ Large Insects EEC 0.72 0.71 0.47 RQ 0.00 0.00 0.00 Small Herbivore Mammals EEC N/A 115.03 17.88 RQ N/A 0.08 0.01 Small Insectivore Mammal EEC N/A 7.19 1.12 RQ N/A 0.01 0.00 Small Amphibians EEC N/A 0.22 0.15 RQ N/A 0.00 0.00 Table 5-15. Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (1.425 Ibs a.i./acre, 1 application) Size Class (grams) 1.4 37 238 Adjusted LD50 1421.00 1421.00 1421.00 EECs and RQs Broadleaf Plants/ Small Insects EEC 7.79 7.65 5.02 RQ 0.01 0.01 0.00 Fruits/Pods/ Seeds/ Large Insects EEC 0.87 0.85 0.56 RQ 0.00 0.00 0.00 Small Herbivore Mammals EEC N/A 137.76 21.42 RQ N/A 0.10 0.02 Small Insectivore Mammal EEC N/A 8.61 1.34 RQ N/A 0.01 0.00 Small Amphibians EEC N/A 0.27 0.17 RQ N/A 0.00 0.00 Table 5-16. Upper Bound Kenaga, Acute Terrestrial Herpetofauna Dose-Based Risk Quotients (6 Ibs a.i./Acre, 1 application) Size Class (grams) Adjusted LD50 EECs and RQs Broadleaf Plants/ Small Insects EEC RQ Fruits/Pods/ Seeds/ Large Insects EEC RQ Small Herbivore Mammals EEC RQ Small Insectivore Mammal EEC RQ Small Amphibians EEC RQ 96 ------- 1.4 37 238 1421.00 1421.00 1421.00 31.47 30.93 20.27 0.02 0.02 0.01 3.50 3.44 2.25 0.00 0.00 0.00 N/A 556.59 86.53 N/A 0.39 0.06 N/A 34.79 5.41 N/A 0.02 0.00 N/A 1.07 0.70 N/A 0.00 0.00 These data suggest that dietary exposures from consumption of insects by terrestrial phase CRLFs is likely to result in exposures that do not exceed LOCs. However, the endangered species LOG was exceeded for large terrestrial phase CRLFs that consume small herbivorous mammals in use sites that receive only 1.425 Ibs a.i./acre or more of pendimethalin applications. The California mouse is a prey item of the CRLF, and this mouse reportedly eats grasses. However, some assumptions included in the assessment of small mammals as a food item are conservative because the CRLF eats a variety of food items and LOCs were not exceeded for CRLFs that eat insectivorous mammals. The RQs for a 37-gram and a 238-gram CRLF that consumes a small herbivore mammal that recently consumed contaminated short grass are found below in Table 5.17. Table 5-17 RQ Comparisons among Weight Class and Applications Rates for CRLF Consuming Small Herbivore Mammal That Recently Consumed Contaminated Short Grass Use site application rate 6.0 6.0 .425 .425 .24 .24 .0 .0 CRLF weight class 37 gram 238 gram 37 gram 238 gram 37 gram 238 gram 37 gram 238 gram Dose-based RQ for small herbivorous mammals 0.39 0.06 0.10 0.02 0.08 0.01 0.07 0.01 RQs remain above the endangered species LOG for CRLFs that consume herbivorous mammals for all uses except where applications are less than 1.425 Ib ai/A. Refinements incorporating dietary habits of CRLFs did not preclude potential risks for CRLFs that consume herbivorous mammals. Current assessment methods of potential risks from chronic exposures for birds do not consider food intake levels. Therefore, T-HERPS does not quantify potential effects of reduced food intake of terrestrial phase CRLFs relative to birds for chronic risk assessments. However, chronic RQs would be expected to be reduced by a similar magnitude seen in the acute analysis. Incident data provided to the Agency indicate that there are two alleged terrestrial incidents in which birds and squirrels were killed. In both of these incidents there was no chemical analysis for pendimethalin made of the corpses. Therefore, the allegation that pendimethalin was responsible for the deaths of the birds and squirrels was not confirmed but yet pendimethalin can not be precluded. 97 ------- Acute and chronic LOCs were exceeded for birds (as surrogate for CRLF). The available toxicity data suggest that amphibians are less sensitive than birds to pendimethalin, and considering factors such as lower food intake of terrestrial phase amphibians relative to birds reduces EECs and RQs, but does not reduce RQs to levels that are below LOCs. Potential effects to CRLFs that consume herbivorous mammals cannot be precluded. Based on the weight-of-evidence, there is a potential direct impact to the terrestrial-phase of the CRLF based on the avian acute and chronic toxicity endpoints as a surrogate for terrestrial-phase CRLF. The effects determination of likely to adversely affect (LAA) terrestrial-phase CRLF from direct effects is based on acute and chronic listed species LOG exceedances for birds. 5.2.2 Indirect Effects (via Reductions in Prey Base) 5.2.2.1 Algae (non-vascular plants) As discussed in Section 2.5.3, the diet of CRLF tadpoles is composed primarily of unicellular aquatic plants (i.e., algae and diatoms) and detritus. Because the aquatic nonvascular plant RQs exceed the LOG for 15 out of 25 pendimethalin use sites, pendimethalin is considered likely to indirectly affect the aquatic-phase CRLF via effects on aquatic nonvascular plants. There were 604 measurements of pendimethalin in the Sacramento River and San Joaquin-Tulare River basins. There was measurable pendimethalin in 319 of the 604 samples (53% positive). The highest concentration recorded (0.679 ppb) in the San Joaquin-Tulare River Basin. All 9 measurements at this site were positive for pendimethalin, with a range of 0.262 to 0.679 ppb. LOCs that were exceeded have EECs from the modeled PRZM_EXAMS ranging from peak of 48 ppb (rice model scenario) to 5.6 ppb. EECs that fall below 5.2 ppb did not exceed the LOG for aquatic plants. The lowest LOG exceedance which has a peak EEC of 5.6 also has a 60-day EEC of 0.8 ppb which is similar to the peak monitoring concentration detected in surface water in California. There are four aquatic non-vascular plant studies submitted to the Agency. The ECso results of these studies range from 5.2 ppb to >174 ppb. Three of the four species have similar results. The ECso data on the species are below: Species tested EC^n Green algae (Selenastmm capricornutum) 5.4 ppb Marine diatom (Skeletonema costatum) 5.2 ppb Freshwater diatom (Navicula pelliculosa) 6.7 ppb Bluegreen algae (Anabaena flos-aquae) >174 ppb MRID Source 42372204 42372205 42372206 42372207 98 ------- Based on the Agency's LOG for aquatic plants being exceeded and that 3 out of 4 species have sensitive ECso similarities; there is a potential indirect impact to the CRLF from reduction of aquatic food items. The effects determination for the CRLF based on potential reductions in algae is "likely to adversely affect" (LAA). 5.2.2.2 Aquatic Invertebrates The potential for pendimethalin to elicit indirect effects to the CRLF via effects on freshwater invertebrate food items is dependent on several factors including: (1) the potential magnitude of effect on freshwater invertebrate individuals and populations; and (2) the number of prey species potentially affected relative to the expected number of species needed to maintain the dietary needs of the CRLF. Together, these data provide a basis to evaluate whether the number of individuals within a prey species is likely to be reduced such that it may indirectly affect the CRLF. There are no aquatic invertebrate's chronic (1.0) or acute (0.5) exceedances of LOG found in section 5.1.1.2. There are two scenarios (rice and forestry) in which the RQ lies between the listed species LOG of 0.05 and the acute LOG of 0.5. The probability of individual effect at RQ for RQ of 0.17 is 1 in 3740 and for the listed species of 0.06 is 1 in 5.22E+07. The scenario with an RQ of 0.17 used a conservative scenario (Rice model) which is a direct instantaneous deposition to a water column. It does not take into account runoffs, dilution, or holding patterns before releasing into the environment. Thus the EEC may be an overestimation of the amount of pendimethalin concentration found waters from rice fields that are released into environs. The probability of individual effect at RQ analysis indicates that the chance of adverse effect to the aquatic invertebrate population is not significant. Other aquatic invertebrate acute toxicity studies were submitted to the Agency. Another waterflea {Daphnia magna) study tested with a formulation of 45.6% active ingredient of pendimethalin. This study showed an ECso of 5.1 ppm formulated product. A submitted crayfish (Procambarus simulans) study showed an ECso greater than 1.0 ppm (1,000 ppb). This study is considered to be supplemental due to precipitation was seen of concentrations over 1 ppm, the dissolved 62 concentration is less than 40% of saturation, and DMSO was used as a solvent which tends to increase mortalities rather than decrease them. Both studies show that other aquatic invertebrates have orders of magnitude less sensitivity than the Daphnia magna surrogate. There were 604 measurements of pendimethalin in the Sacramento River and San Joaquin-Tulare River basins. There was measurable pendimethalin in 319 of the 604 samples (53% positive). The highest concentration recorded (0.679 ppb) in the San Joaquin-Tulare River Basin. All 9 measurements at this site were positive for pendimethalin, with a range of 0.262 to 0.679 ppb which is well below the toxicity level of Daphnia magna ECso of 280 ppb by three orders of magnitude. 99 ------- Based on the weight-of-evidence of chronic and acute LOG not being exceeded for aquatic invertebrates; the probit slope analysis showing probability of effect being insignificant; and species sensitivity among other aquatic invertebrates being less sensitive than the surrogate invertebrate; the effects determination for the CRLF based on potential reductions in aquatic invertebrates is "not likely to adversely affect" (NLAA). 5.2.2.3 Fish and Aquatic-phase Frogs In the absence of toxicity data for amphibians, the most sensitive acute and chronic toxicity values across fish species tested. RQs were based on acute studies in rainbow trout (LC50 =138 ug/L, MRID 00046291) and a chronic NOAEC in fathead minnow (NOAEC = 6.3 ug/L, MRID 00037940). The highest acute RQ from the rice model was 0.0.35. The acute LOG is 0.5. Based on a default probit slope value of 4.5 for the rainbow trout with 95% confidence intervals of 2 to 9, the associated probability of an individual effect would be approximately 1 in 49.8. The scenario with an RQ of 0.12 used a conservative scenario (Rice model) which is a direct instantaneous deposition to a water column. It does not take into account runoffs, dilution, or holding patterns before releasing into the environment. Thus the EEC may be an overestimation of the amount of pendimethalin concentration found waters from rice fields that are released into environs. The next highest RQ is 0.12 from a forestry and Christmas tree use sites. The associated probability of an individual effect would be approximately 1 in 5.85E+04. Eleven scenarios have LOCs that are between the acute LOG (0.5) and the listed species LOG (0.05) and their RQs range from 0.12 to 0.05. The probability of individual effect at RQ for RQs of 0.17 to 0.05 is 1 in 5.85E+04 to 1 in 4.18E+08. The probability of individual effect at RQ analysis indicates that the chance of adverse effect to the aquatic invertebrate population is not be significant. The most sensitive chronic toxicity value is based on a life cycle study in fathead minnow. The chronic RQ (0.8) is based on a NOAEC of 6.3 ug/L from an acceptable life-cycle study (MRID 00024377). Most sensitive endpoint was reduction in egg production that was observed at LOAEC of 44 ug/L. Based on no acute or chronic exceedances and the low probability of an individual effect; the effects determination for the CRLF based on potential reductions in fish and other amphibians as food items of the aquatic-phase CRLF is "not likely to adversely affect" (NLAA). 5.2.2.4 Terrestrial Invertebrates When the terrestrial-phase CRLF reaches juvenile and adult stages, its diet is mainly composed of terrestrial invertebrates. 100 ------- Toxicity data from honey bee study (MRID 00099890) show the LD50 to be greater than 49.8 jig/Bee. No mortalities were observed at the highest concentration. Based upon an average fresh weight per honey bee of 128 milligrams, the LD50 of honey bees (jig /bee) can be multiplied by 7.8 to determine the ppm toxicity. The toxicity equivalence in ppm would be 388 ppm. According to the Hoerger, Kenaga5 nomogram modified by Fletcher6, the highest EEC exposure from 6 Ib ai/A application to large insects would be 90 ppm and to small insects would be 810 ppm. The EEC of small insects is about 2X more than the highest dose tested. The EEC of the largest insect is less than 2X the dose tested. Although there are no mortalities of the honey bee at the highest dose tested and that under the Agency's guidelines, pendimethalin is considered to be practically non-toxic to honey bee; the honey bee study did not test up to the highest dose that could be expected from 6 Ib ai/A directly onto small insects at the site of application. There is some uncertainty due to the highest concentration dose tested on the bee was well below the equivalent of 6 Ib ai/A maximum application. There was no mortality at the highest dose tested, yet it is uncertain if mortality will exist if a higher dose was used in the bee study that would reflect the maximum application rate. Therefore, potential risk can not be precluded to terrestrial invertebrates as a food item. Because potential risk can not be precluded to terrestrial invertebrates as a food item; the effects determination for the CRLF based on potential reductions in terrestrial invertebrates as prey items is "likely to adversely affect" (LAA). 5.2.2.5 Mammals Terrestrial phase CRLFs consume small mammals. This assessment used a 15-gram herbivorous mammal to determine if there could be a potential reduction in mammal abundance. Acute dose-based RQs for a 15-gram mammal ranged from 0.1 to 0.6 depending on the use pattern. Assuming a probit slope of 4.5, the probability of an individual effect would be approximately 1 in 6.9. Assuming that probability of an individual effect provides insight into the potential for reductions in a local population of small mammals, a probability of 1 in 6.9 (15.9%) would result in a measurable impact to mammal abundance and would, therefore, constitute a significant effect. Reproduction RQs ranged from 5.2 to 25.0. The toxicity endpoint used in the RQs was based on a parental systemic and reproductive NOAEL of 25 mg/kg-bw/day. The 5 Hoerger, F. and E.E. Kenaga. 1972. Pesticide residues on plants: correlation of representative data as a basis for estimation of their magnitude in the environment. IN: F. Coulston and F. Corte, eds., Environmental Quality and Safety: Chemistry, Toxicology and Technology. Vol 1. Georg Theime Publishers, Stuttgart, Germany, pp. 9-28 6 Fletcher, J.S., J.E. Nellesson and T. G. Pfleeger. 1994. Literature review and evaluation of the EPA food- chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Environ. Tox. and Chem. 13(9):1383-1391 101 ------- parental systemic endpoint was based on decreased body weight gain and food consumption at the LOAEL of 125 mg/kg/day (500 ppm). The reproductive/offspring NOAEL is 25 mg/kg/day (500 ppm), based on decreases in the number of pups born and pup weight at the LOAEL of 125 mg/kg/day (2500 ppm) which may be a significant population effect. The RQs indicate that potential exposures exceed the NOAEL for all uses. Due to the chronic LOG being exceeded for small mammal prey and the reproductive endpoint is based on decreasing numbers of pups born and pup weight, the effects determination for the potential for pendimethalin to indirectly affect the CRLF from potential impacts to mammalian prey is likely to adversely affect (LAA). 5.2.2.6 Terrestrial-phase Amphibians The effects determination for terrestrial phase CRLF consuming small mammalian prey was "likely to adversely affect" (LAA). This determination was based solely on frogs that consume potentially contaminated herbivore mammals. Terrestrial amphibian prey of the CRLF includes small amphibians such as tree frogs that do not prey on mammals. Therefore, the mammalian food group is not relevant in the evaluation of potential reductions in amphibian prey abundance. Avian (as surrogate for frog and CRLF) listed species RQs exceeded LOCs (0.1) (Section 5.1). Acute LOCs (0.5) were not exceeded for insectivorous amphibians using the T- HERPS model (Table 5.16) at the highest rate of application (6 Ib ai/A). Therefore, reductions from acute effects in amphibian prey as a food item at levels likely to affect the CRLF are not likely to occur, and the effects determination for the CRLF based on potential reductions in terrestrial amphibians is "not likely to adversely affect" (NLAA). Since the chronic LOG have been exceeded, the effects determination for the CRLF based on potential reductions in terrestrial-phase amphibians as food item is "likely to adversely affect" (LAA) from chronic LOG exceedances. 5.2.3 Indirect Effects (via Habitat Effects) 5.2.3.1 Aquatic Plants (Vascular and Non-vascular) Aquatic plants serve several important functions in aquatic ecosystems. Non-vascular aquatic plants are primary producers and provide the autochthonous energy base for aquatic ecosystems. Vascular plants provide structure as attachment sites and refugia for many aquatic invertebrates, fish, and juvenile organisms, such as fish and frogs. In addition, vascular plants also provide primary productivity and oxygen to the aquatic ecosystem. Rooted plants help reduce sediment loading and provide stability to nearshore areas and lower streambanks. In addition, vascular aquatic plants are important as attachment sites for egg masses of CRLFs. 102 ------- Potential indirect effects to the CRLF based on impacts to habitat and/or primary production were assessed using RQs from freshwater aquatic vascular and non-vascular plant data. Section 5.2.2.1 indicates that pendimethalin is likely to adversely impact non- target aquatic plants. LOCs are exceeded for aquatic vascular plants and algae from exposure to pendimethalin from runoff or spray drift. The non-vascular RQs that exceed LOG range from 1.1 to 9.2 and exceed the LOG for 15 out of 25 pendimethalin aquatic model scenarios. The vascular plant LOG is exceeded for 2 of the 25 aquatic model scenarios with the RQs of 1.3 and 3.8. There were 604 measurements of pendimethalin in the Sacramento River and San Joaquin-Tulare River basins. There was measurable pendimethalin in 319 of the 604 samples (53% positive). The highest concentration recorded (0.679 ppb) were found in the San Joaquin-Tulare River Basin. All 9 measurements at this site were positive for pendimethalin, with a range of 0.262 to 0.679 ppb. LOCs that were exceeded have EECs from the modeled PRZM_EXAMS ranging from peak of 48 ppb (rice model scenario) to 5.6 ppb. EECs that fall below 5.2 ppb did not exceed the LOG for aquatic nonvascular plants and 12.5 ppb for the aquatic vascular plants. Potential indirect effects to the CRLF based on impacts to habitat and/or primary production were assessed using RQs from freshwater aquatic vascular and non-vascular plant data. Based on the LOG exceedances, there is a potential indirect impact to the aquatic-phase-CRLF from aquatic habitat degradation. The effects determination for the aquatic-phase CRLF is "likely to adversely affect" (LAA). 5.2.3.2 Terrestrial Plants Terrestrial plants serve several important habitat-related functions for the CRLF. In addition to providing habitat and cover for invertebrate and vertebrate prey items of the CRLF, terrestrial vegetation also provides shelter for the CRLF and cover from predators while foraging. Terrestrial plants also provide energy to the terrestrial ecosystem through primary production. Upland vegetation including grassland and woodlands provides cover during dispersal. Riparian vegetation helps to maintain the integrity of aquatic systems by providing bank and thermal stability, serving as a buffer to filter out sediment, nutrients, and contaminants before they reach the watershed, and serving as an energy source. The terrestrial non-target plant LOG is exceeded for all use sites. The RQs are variable according to the method of application used (aerial or ground application) and the amount of active ingredient used. Table 5.18 below shows the range of RQs from different application methods. Table 5-18. Range of Risk Quotients for Non-Target Terrestrial Plants from Pendimethalin Usage | Application | Spray | Runoff to Low-Lying | Runoff to dry 103 ------- Application Rate 6.0 Ib ai/A 4.0 Ib ai/A 3.5 Ib ai/A 2.0 Ib ai/A 1.485 Ib ai/A 1.0 Ib ai/A 4.0 Ib ai/A 3. 5 Ib ai/A 2.0 Ib ai/A 1. 485 Ib ai/A l.Olbai/A Method ground ground ground ground ground ground aerial aerial aerial aerial aerial Drift RQ 6.0 4.0 3.5 2.0 1.5 1.0 20.0 17.5 10.0 7.4 5.0 semi-aquatic areas 66.0 44.0 38.5 22.0 16.3 11.0 60.0 52.5 30.0 22.3 15.0 adjacent areas 12.0 8.0 7.0 4.0 3.0 2.0 24.0 21.0 12.0 8.9 6.0 Bold denotes that the RQ has exceeded the LOC. Although the endpoint used for runoff (seedling emergence) is 3X more sensitive than the spray drift toxicity endpoint (vegetative vigor), there is more LOC exceedances from aerial application than from runoff. This is due to the fate characteristics of pendimethalin. Pendimethalin binds more closely to the soil and is usually carried with soil during a runoff event rather than with water. The most sensitive monocot appears to be more sensitive than the most sensitive dicot tested by an order of magnitude. Differences of responses between the dicots and monocots are mixed and do overlap. Overall, monocots and dicots are both sensitive to pendimethalin. The herbicidal mode of action of pendimethalin is that it disrupts the process of mitosis in the growth of shoots and roots. It acts as a microtubule disrupter by inhibiting cell division and cell elongation in plants. Absorption of the chemical into plant is via roots and shoots. Based on the weight-of-evidence, the Agency concludes that there is a potential indirect impact to CRLF by terrestrial habitat degradation from pendimethalin exposure and therefore pendimethalin is Likely to Adversely Affect (LAA) the CRLF both riparian and upland vegetation. If aerial application was to be eliminated at least 1000 feet of CRLF habitat, potential risk would be reduced. 5.2.4 Effects to Designated Critical Habitat Risk conclusions for the designated critical habitat are the same as those for indirect effects. Agency concludes that there is a potential indirect impact to CRLF by terrestrial and aquatic habitat degradation from pendimethalin exposure. 5.2.4.1 Aquatic-Phase PCEs 104 ------- Three of the four assessment endpoints for the aquatic-phase primary constituent elements (PCEs) of designated critical habitat for the CRLF are related to potential effects to aquatic and/or terrestrial plants: • Alteration of channel/pond morphology or geometry and/or increase in sediment deposition within the stream channel or pond: aquatic habitat (including riparian vegetation) provides for shelter, foraging, predator avoidance, and aquatic dispersal for juvenile and adult CRLFs. • Alteration in water chemistry/quality including temperature, turbidity, and oxygen content necessary for normal growth and viability of juvenile and adult CRLFs and their food source. • Reduction and/or modification of aquatic-based food sources for pre-metamorphs (e.g., algae). Conclusions for potential indirect effects to the CRLF via direct effects to aquatic and terrestrial plants are used to determine whether modification to critical habitat may occur. There is a potential for habitat effects via impacts to aquatic plants (Sections 5.2.2.1 and 5.2.3.1) and terrestrial plants (5.2.3.2) The remaining aquatic-phase PCE is "alteration of other chemical characteristics necessary for normal growth and viability of CRLFs and their food source." Other than impacts to algae as food items for tadpoles (discussed above), this PCE is assessed by considering direct and indirect effects to the aquatic-phase CRLF via acute and chronic freshwater fish and invertebrate toxicity endpoints as measures of effects. There is a potential for habitat effects via impacts to aquatic-phase CRLFs (Sections 5.2.1.1) and effects to freshwater invertebrates and fish as food items (Sections 5.2.2.2 and 5.2.2.3). 5.2.4.2 Terrestrial-Phase PCEs Two of the four assessment endpoints for the terrestrial-phase PCEs of designated critical habitat for the CRLF are related to potential effects to terrestrial plants: • Elimination and/or disturbance of upland habitat; ability of habitat to support food source of CRLFs: Upland areas within 200 ft of the edge of the riparian vegetation or drip line surrounding aquatic and riparian habitat that are comprised of grasslands, woodlands, and/or wetland/riparian plant species that provides the CRLF shelter, forage, and predator avoidance. • Elimination and/or disturbance of dispersal habitat: Upland or riparian dispersal habitat within designated units and between occupied locations within 0.7 mi of each other that allow for movement between sites including both natural and altered sites which do not contain barriers to dispersal. There is a potential for habitat effects via impacts to terrestrial plants (5.2.3.2). 105 ------- The third terrestrial-phase PCE is "reduction and/or modification of food sources for terrestrial phase juveniles and adults." To assess the impact of pendimethalin on this PCE, acute and chronic toxicity endpoints for terrestrial invertebrates, mammals, and terrestrial-phase frogs are used as measures of effects. There is a potential for habitat effects via indirect effects to terrestrial-phase CRLFs via reduction in prey base (Section 5.2.2.4 for terrestrial invertebrates, Section 5.2.2.5 for mammals, and 5.2.2.6 for frogs). The fourth terrestrial-phase PCE is based on alteration of chemical characteristics necessary for normal growth and viability of juvenile and adult CRLFs and their food source. There is a potential for habitat modification via direct (Section 5.2.1.2) and indirect effects (Sections 5.2.2.4, 5.2.2.5, and 5.2.2.6) to terrestrial-phase CRLFs. 5.2.5 Spatial Extent of Potential Effects An LAA effects determination applies to those areas where it is expected that the pesticide's use will directly or indirectly affect the CRLF or its designated critical habitat. To determine this area, the footprint of pendimethalin's use pattern is identified, using land cover data that correspond to pendimethalin's use pattern. The spatial extent of the effects determination also includes areas beyond the initial area of concern that may be impacted by runoff and/or spray drift. The identified direct/indirect effects and/or modification to critical habitat are anticipated to occur only for those currently occupied core habitat areas, CNDDB occurrence sections, and designated critical habitat for the CRLF that overlap with the initial area of concern plus at least 1000 feet from its boundary. It is assumed that non-flowing waterbodies (or potential CRLF habitat) are included within this area. In addition to the spray drift buffer, the results of the downstream dilution extent analysis result in a distance of 272 kilometers which represents the maximum continuous distance of downstream dilution from the edge of the initial area of concern (based on the forestry use; see Appendix D). If any of these streams reaches flow into CRLF habitat, there is potential to affect either the CRLF or modify its habitat. These lotic aquatic habitats within the CRLF core areas and critical habitats potentially contain concentrations of pendimethalin sufficient to result in LAA determination or effects to critical habitat. The determination of the buffer distance and downstream dilution for spatial extent of the effects determination is described below. 5.2.5.1 Spray Drift In order to determine terrestrial and aquatic habitats of concern due to pendimethalin exposures through spray drift, it is necessary to estimate the distance that spray applications can drift from the treated area and still be present at concentrations that exceed levels of concern. An analysis of spray drift distances was completed using the AgDrift model. 106 ------- In order to characterize the spatial extent of the effects determination that is relevant to the CRLF (i.e. NLAA versus LAA), an analysis was conducted using the most sensitive non-endangered plant £€25 of 0.01 Ibs ai/acre (ryegrass seedling emergence). Typically the NOAEC is used when there is an obligate relationship between the species being assessed and endangered plants (or other taxa). However, there is no obligate relationship between the CRLF and any endangered plant; therefore the LAA/NLAA determination is based on the area defined by the non-listed species LOG (i.e., EEC/EC5o). The most sensitive effect of concern was the lowest EC25 for seedling emergence, 0.01 Ib/acre for ryegrass. Tier 1 ground spray analysis (terrestrial assessment) was performed with the AgDrift model. The following settings were used: High boom, ASAE very fine to fine spray, point deposition, and an application rate of 6 Ib/acre. The resulting buffer distance for ground spray was 899 feet. A similar analysis was performed using AgDrift, using the Tier 1 aerial (terrestrial) assessment with ASAE very fine to fine spray, point deposition, and an application rate of 4 Ib/acre. The resulting buffer exceeds the limit of the AgDrift model (approximately 1000 feet). A Tier 2 AgDrift aerial analysis was also conducted, with the same result (over 1000 feet). A summary of the modeled distances by application rate is presented in Table 5.19. Table 5-19 Summary of AgDrift Predicted Terrestrial Spray Drift Distances Application Rate (method) 6.0 (ground) 4.0 (aerial) Uses Represented EC25 Distance (ft) 899 Over 1000 Given that the greatest buffer distance is 1,000 feet for terrestrial plants, this value was used to define the spatial extent of the effects determination (i.e., this buffer distance is added to the initial area of concern). Similar to the analysis described above, the buffer distance needed to get below the most sensitive aquatic LOG was determined. This distance identifies those locations where water bodies can be impacted by spray drift deposition alone (no runoff considered) resulting in concentrations above the LOG. The most sensitive aquatic endpoint is for aquatic non-vascular plants (Skeletonema) with an ECso value of 5.2 |ig/L. The analysis yields a much lower ground-spray buffer distance than the terrestrial buffer with a distance of 79 feet (based on the non-listed LOG using the ECso value). However, the Tier 1 and 2 aerial analysis again yields a distance of over 1,000 feet. The results of the analysis are presented in Table 5.20. Table 5-20 Summary of AgDrift Predicted Aquatic Spray Drift Distances Application Rate (method) Uses Represented 107 EC50 Distance (ft) ------- Application Rate (method) 6.0 (ground) 4.0 (aerial) Uses Represented EC50 Distance (ft) 79 Over 1000 5.2.5.2 Downstream Dilution Analysis The downstream extent of exposure in streams and rivers is where the EEC could potentially be above levels that would exceed the most sensitive LOG. To complete this assessment, the greatest ratio of aquatic RQ to LOG was estimated. Using an assumption of uniform runoff across the landscape, it is assumed that streams flowing through treated areas (i.e. the initial area of concern) are represented by the modeled EECs; as those waters move downstream, it is assumed that the influx of non-impacted water will dilute the concentrations of pendimethalin present. Using an EC50 value of 5.2 ug/L for non-vascular aquatic plants (the most sensitive species is Skeletonema costatum) and a maximum peak EEC for applications to rice of 48 ug/L yields an RQ/LOC ratio of 9.2 (9.2/1), which is applied to the pasture/hay and cultivated crop land cover class. RQ/LOC ratios for other use categories range from 2.3 to 3.2. Using the downstream dilution approach (described in more detail in Appendix D) yields a target percent crop area (PCA) of 11% for the ratio of 9.2. This value has been input into the downstream dilution approach and results in a distance of 47 kilometers. However, the forestry RQ/LOC ratio of 3.2 yields a downstream dilution distance of 272 kilometers, which represents the maximum continuous distance of downstream dilution from the edge of the initial area of concern, for the forestry land cover class. Similar to the spray drift buffer described above, the LAA/NLAA determination is based on the area defined by the point where concentrations exceed the value. 5.2.5.3 Overlap between CRLF habitat and Spatial Extent of Potential Effects An LAA effects determination is made to those areas where it is expected that the pesticide's use will directly or indirectly affect the CRLF or its designated critical habitat and the area overlaps with the core areas, critical habitat and available occurrence data for CRLF. For pendimethalin, the use patterns fall into the following land cover classes: Cultivated Crops; Developed, High Intensity; Developed, Low Intensity; Developed, Medium Intensity; Developed, Open Space; Forest; Open Water; Orchards and vineyards; Pasture/Hay; Wetlands; Turf; and Rights-of-way. The overlap area also includes areas beyond the initial area of concern that may be impacted by runoff and/or spray drift, where it overlaps with CRLF habitat. Appendix D provides maps of the initial area of concern, along with CRLF habitat areas, including currently occupied core 108 ------- areas, CNDDB occurrence sections, and designated critical habitat. It is expected that any additional areas of CRLF habitat that are located at least 1000 ft (to account for offsite migration via spray drift) and 272 kilometers of stream reach (to account for downstream dilution) outside the initial area of concern may also be impacted and are part of the full spatial extent of the LAA and effects to critical habitat determination. 109 ------- Figure 2.6. Overlap Map: CRLF Habitat and Pendimethalin Initial Area of Concern Pendimethalin Use & CRLF Habitat Overlap Pendimethalin use & CRLF overlap CNDDB occurrence sections Critical habitat Core areas County1 boundaries i Kilo meters 02040 80 120 180 Compiled from California County boundaries (ESRI, 2002), USDA Gap Analysis Program Orchard/Vineyard Landcover (GAP) National Land Cower Database (NLCD) (MRLC, 2001) Map created by US Environmental Protection Agency, Office of Pesticides Programs, Environmental Fate and Effects Dwision. Projection: Albers Equal Area Conic USGS, North American Datum of 1983(I\1AD1983). 5/26/2009 110 ------- In order to confirm that uses of pendimethalin have the potential to affect CRLF through direct applications to target areas and runoff and spray drift to non-target areas, it is necessary to determine whether or not the spatial extent of potential effects based on agricultural and orchard crops and turf use of pendimethalin overlap with CRLF habitats. Spatial analysis using ArcGIS 9.1 indicates that lotic aquatic habitats within the CRLF core areas and critical habitats potentially contain concentrations of pendimethalin sufficient to result in RQ values that exceed LOCs. In addition, terrestrial habitats (and potentially lentic aquatic habitats) of the final action areas for agricultural, forestry, rights-of ways, ornamental, and turf uses of pendimethalin overlap with the core areas, critical habitat and available occurrence data for CRLF (Figure 2.6). Thus, uses of pendimethalin on agricultural and orchard crops and turf use could result in exposures of the CRLF to pendimethalin in aquatic and terrestrial habitats. 6.0 Uncertainties 6.1 Exposure Assessment Uncertainties 6.1.1 Maximum Use Scenario The screening-level risk assessment focuses on characterizing potential ecological risks resulting from a maximum use scenario, which is determined from labeled statements of maximum application rate and number of applications with the shortest time interval between applications. The frequency at which actual uses approach this maximum use scenario may be dependant on pest resistance, timing of applications, cultural practices, and market forces. 6.1.2 Aquatic Exposure Modeling of Pendimethalin The standard ecological water body scenario (EXAMS pond) used to calculate potential aquatic exposure to pesticides is intended to represent conservative estimates, and to avoid underestimations of the actual exposure. The standard scenario consists of application to a 10-hectare field bordering a 1-hectare, 2-meter deep (20,000 m3) pond with no outlet. Exposure estimates generated using the EXAMS pond are intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man-made and natural ponds, and intermittent and lower order streams. As a group, there are factors that make these water bodies more or less vulnerable than the EXAMS pond. Static water bodies that have larger ratios of pesticide-treated drainage area to water body volume would be expected to have higher peak EECs than the EXAMS pond. These water bodies will be either smaller in size or have larger drainage areas. Smaller water bodies have limited storage capacity and thus may overflow and carry pesticide in the discharge, whereas the EXAMS pond has no discharge. As watershed size increases beyond 10-hectares, it becomes increasingly unlikely that the entire watershed is planted with a single crop that is all treated simultaneously with the pesticide. Headwater streams can also have peak concentrations higher than the EXAMS pond, but they likely persist for only short periods of time and are then carried and dissipated downstream. Ill ------- The Agency acknowledges that there are some unique aquatic habitats that are not accurately captured by this modeling scenario and modeling results may, therefore, under- or over-estimate exposure, depending on a number of variables. For example, aquatic-phase CRLFs may inhabit water bodies of different size and depth and/or are located adjacent to larger or smaller drainage areas than the EXAMS pond. The Agency does not currently have sufficient information regarding the hydrology of these aquatic habitats to develop a specific alternate scenario for the CRLF. CRLFs prefer habitat with perennial (present year-round) or near-perennial water and do not frequently inhabit vernal (temporary) pools because conditions in these habitats are generally not suitable (Hayes and Jennings 1988). Therefore, the EXAMS pond is assumed to be representative of exposure to aquatic-phase CRLFs. In addition, the Services agree that the existing EXAMS pond represents the best currently available approach for estimating aquatic exposure to pesticides (USFWS/NMFS 2004). In general, the linked PRZM/EXAMS model produces estimated aquatic concentrations that are expected to be exceeded once within a ten-year period. The Pesticide Root Zone Model is a process or "simulation" model that calculates what happens to a pesticide in an agricultural field on a day-to-day basis. It considers factors such as rainfall and plant transpiration of water, as well as how and when the pesticide is applied. It has two major components: hydrology and chemical transport. Water movement is simulated by the use of generalized soil parameters, including field capacity, wilting point, and saturation water content. The chemical transport component can simulate pesticide application on the soil or on the plant foliage. Dissolved, adsorbed, and vapor-phase concentrations in the soil are estimated by simultaneously considering the processes of pesticide uptake by plants, surface runoff, erosion, decay, volatilization, foliar wash-off, advection, dispersion, and retardation. Uncertainties associated with each of these individual components add to the overall uncertainty of the modeled concentrations. Additionally, model inputs from the environmental fate degradation studies are chosen to represent the upper confidence bound on the mean values that are not expected to be exceeded in the environment approximately 90 percent of the time. Mobility input values are chosen to be representative of conditions in the environment. The natural variation in soils adds to the uncertainty of modeled values. Factors such as application date, crop emergence date, and canopy cover can also affect estimated concentrations, adding to the uncertainty of modeled values. Factors within the ambient environment such as soil temperatures, sunlight intensity, antecedent soil moisture, and surface water temperatures can cause actual aquatic concentrations to differ for the modeled values. Unlike spray drift, tools are currently not available to evaluate the effectiveness of a vegetative setback on runoff and loadings. The effectiveness of vegetative setbacks is highly dependent on the condition of the vegetative strip. For example, a well- established, healthy vegetative setback can be a very effective means of reducing runoff and erosion from agricultural fields. Alternatively, a setback of poor vegetative quality or a setback that is channelized can be ineffective at reducing loadings. Until such time 112 ------- as a quantitative method to estimate the effect of vegetative setbacks on various conditions on pesticide loadings becomes available, the aquatic exposure predictions are likely to overestimate exposure where healthy vegetative setbacks exist and underestimate exposure where poorly developed, channelized, or bare setbacks exist. In order to account for uncertainties associated with modeling, available monitoring data were compared to PRZM/EXAMS estimates of peak EECs for the different uses. As discussed above, several data values were available from NAWQA for pendimethalin concentrations measured in surface waters receiving runoff from agricultural areas. The specific use patterns (e.g. application rates and timing, crops) associated with the agricultural areas are unknown, however, they are assumed to be representative of potential pendimethalin use areas. The monitoring data available are within same order of magnitude as the PRZM-EXAMS predictions, or slightly lower, for the agricultural and forestry scenarios. The monitoring data indicated that the maximum observed concentration in Sacramento River valley streams was 0.7 ppb, and in San Joaquin Valley streams it was 3.5 ppb. PRZM-EXAMS prediction (not including the scenarios for impervious surfaces) estimated pendimethalin to be in the surface waters at peak concentrations from 3 to 16 ppb. The impervious scenario was much higher at 143 ppb. 6.1.3 Usage Uncertainties County-level usage data were obtained from California's Department of Pesticide Regulation Pesticide Use Reporting (CDPR PUR) database. Thirteen years of data (1994 - 2006) were included in this analysis. Because statistical methodology for identifying outliers, in terms of area treated and pounds applied, was not provided by CDPR for years before 2002, these data are less accurate. No methodology for removing outliers was provided by CDPR for 2001 and earlier pesticide data; therefore, this information was included separately in the analysis because it may misrepresent actual usage patterns. CDPR PUR documentation indicates that errors in the data may include the following: a misplaced decimal; incorrect measures, area treated, or units; and reports of diluted pesticide concentrations. In addition, it is possible that the data may contain reports for pesticide uses that have been cancelled. The CPDR PUR data does not include home owner applied pesticides; therefore, residential uses are not likely to be reported. As with all pesticide usage data, there may be instances of misuse and misreporting. The Agency made use of the most current, verifiable information; in cases where there were discrepancies, the most conservative information was used. 6.1.4 Terrestrial Exposure Modeling of Pendimethalin The Agency relies on the work of Fletcher et al. (1994) for setting the assumed pesticide residues in wildlife dietary items. These residue assumptions are believed to reflect a realistic upper-bound residue estimate, although the degree to which this assumption reflects a specific percentile estimate is difficult to quantify. It is important to note that the field measurement efforts used to develop the Fletcher estimates of exposure involve 113 ------- highly varied sampling techniques. It is entirely possible that much of these data reflect residues averaged over entire above ground plants in the case of grass and forage sampling. It was assumed that ingestion of food items in the field occurs at rates commensurate with those in the laboratory. Although the screening assessment process adjusts dry- weight estimates of food intake to reflect the increased mass in fresh-weight wildlife food intake estimates, it does not allow for gross energy differences. Direct comparison of a laboratory dietary concentration- based effects threshold to a fresh-weight pesticide residue estimate would result in an underestimation of field exposure by food consumption by a factor of 1.25 - 2.5 for most food items. Differences in assimilative efficiency between laboratory and wild diets suggest that current screening assessment methods do not account for a potentially important aspect of food requirements. Depending upon species and dietary matrix, bird assimilation of wild diet energy ranges from 23 - 80%, and mammal's assimilation ranges from 41 - 85% (U.S. Environmental Protection Agency, 1993). If it is assumed that laboratory chow is formulated to maximize assimilative efficiency (e.g., a value of 85%), a potential for underestimation of exposure may exist by assuming that consumption of food in the wild is comparable with consumption during laboratory testing. In the screening process, exposure may be underestimated because metabolic rates are not related to food consumption. For the terrestrial exposure analysis of this risk assessment, a generic bird or mammal was assumed to occupy either the treated field or adjacent areas receiving a treatment rate on the field. Actual habitat requirements of any particular terrestrial species were not considered, and it was assumed that species occupy, exclusively and permanently, the modeled treatment area. Spray drift model predictions suggest that this assumption leads to an overestimation of exposure to species that do not occupy the treated field exclusively and permanently. 6.1.5 Spray Drift Modeling Although there may be multiple pendimethalin applications at a single site, it is unlikely that the same organism would be exposed to the maximum amount of spray drift from every application made. In order for an organism to receive the maximum concentration of pendimethalin from multiple applications, each application of pendimethalin would have to occur under identical atmospheric conditions (e.g., same wind speed and - for plants - same wind direction) and (if it is an animal) the animal being exposed would have to be present directly downwind at the same distance after each application. Although there may be sites where the dominant wind direction is fairly consistent (at least during the relatively quiescent conditions that are most favorable for aerial spray applications), it is nevertheless highly unlikely that plants in any specific area would receive the maximum amount of spray drift repeatedly. It appears that in most areas (based upon available meteorological data) wind direction is temporally very changeable, even within the same day. Additionally, other factors, including variations in 114 ------- topography, cover, and meteorological conditions over the transport distance are not accounted for by the AgDRIFT/AGDISP model (i.e., it models spray drift from aerial and ground applications in a flat area with little to no ground cover and a steady, constant wind speed and direction). Therefore, in most cases, the drift estimates from AgDRIFT/AGDISP may overestimate exposure even from single applications, especially as the distance increases from the site of application, since the model does not account for potential obstructions (e.g., large hills, berms, buildings, trees, etc.). Furthermore, conservative assumptions are often made regarding the droplet size distributions being modeled ('ASAE Very Fine to Fine' for orchard uses and 'ASAE Very Fine' for agricultural uses), the application method (e.g., aerial), release heights and wind speeds. Alterations in any of these inputs would change the area of potential effect. 6.1.6 Volatility Pendimethalin is a semi-volatile compound that may be lost from moist soil. The volatilization half-life from moist soil was found to be 12.5 days (MRID 00153766). Pendimethalin has been observed in rainwater in California (Vogel et al., 2008). This effect was accounted for in the PRZM-EXAMS modeling by invoking the PRZM volatilization routine, thus allowing voltilization to compete with runoff and metabolism as a dissipation route. Comparison of the highest EEC scenario (forestry) shows that the effect is small (16.6 ppb with volatility invoked and 18.1 ppb without). The relatively slow volatilization rate from even moist soil is not believed to result in as large or immediate an aquatic exposure as spray drift at the time of application. Terrestrial exposure of plants and animals is accounted for at least in part by the AgDrift and AgDISP effect area analysis. 6.1.7 Bioaccumulation Pendimethalin is believed to be bioaccumulative, as it has a logKow of 5.18, and a whole-body BCF of 5100x in bluegill sunfish (MRID 00156726). PRZM-EXAMS modeling indicates that pendimethalin may accumulate in sediments as well. Thus, food- chain exposure via accumulation in aquatic organisms may be a completed exposure pathway. However, several factors indicate that such exposure may not be a concern. First, additional bioaccumulation data in catfish (approximate BCF = 1600x), guppies (no accumulation, with metabolism) (MRID 00046293) and crayfish (MRID 00071124) whole body BCF = 1.5x) indicate that bioaccumulation is not the only response of aquatic organisms to pendimethalin. Second, the bluegill sunfish exposed to pendimethalin accumulated 15 ppm body burden with no ill effects, followed by depuration. KABAM modeling (Appendix K) indicated some marginal chronic risk for large river otters (chronic dose-based RQ 1.3, but dietary-based RQ 0.169) and marginal acute risk for small CRLF (acute dose-based RQ 0.14 to 0.38, but dietary-based RQ 0.007 to 0.008. However, the assumption of no metabolism in aquatic organisms is probably incorrect, so the results from KABAM showing marginal risks are therefore discountable. 115 ------- 6.2 Effects Assessment Uncertainties 6.2.1 Age Class and Sensitivity of Effects Thresholds It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxicant. The acute toxicity data for fish are collected on juvenile fish between 0.1 and 5 grams. Aquatic invertebrate acute testing is performed on recommended immature age classes (e.g., first instar for daphnids, second instar for amphipods, stoneflies, mayflies, and third instar for midges). Testing of juveniles may overestimate toxicity at older age classes for pesticide active ingredients that act directly without metabolic transformation because younger age classes may not have the enzymatic systems associated with detoxifying xenobiotics. In so far as the available toxicity data may provide ranges of sensitivity information with respect to age class, this assessment uses the most sensitive life-stage information as measures of effect for surrogate aquatic animals, and is therefore, considered as protective of the CRLF. 6.2.2 Use of Surrogate Species Effects Data Guideline toxicity tests and open literature data on pendimethalin are not available for frogs or any other aquatic-phase amphibian; therefore, freshwater fish are used as surrogate species for aquatic-phase amphibians. Therefore, endpoints based on freshwater fish ecotoxicity data are assumed to be protective of potential direct effects to aquatic-phase amphibians including the CRLF, and extrapolation of the risk conclusions from the most sensitive tested species to the aquatic-phase CRLF is likely to overestimate the potential risks to those species. Efforts are made to select the organisms most likely to be affected by the type of compound and usage pattern; however, there is an inherent uncertainty in extrapolating across phyla. In addition, the Agency's LOCs are intentionally set very low, and conservative estimates are made in the screening level risk assessment to account for these uncertainties. 6.2.3 Sublethal Effects When assessing acute risk, the screening risk assessment relies on the acute mortality endpoint as well as a suite of sublethal responses to the pesticide, as determined by the testing of species response to chronic exposure conditions and subsequent chronic risk assessment. Consideration of additional sublethal data in the effects determination t is exercised on a case-by-case basis and only after careful consideration of the nature of the sublethal effect measured and the extent and quality of available data to support establishing a plausible relationship between the measure of effect (sublethal endpoint) 116 ------- and the assessment endpoints. However, the full suite of sublethal effects from valid open literature studies is considered for the purposes of defining the action area. To the extent to which sublethal effects are not considered in this assessment, the potential direct and indirect effects of pendimethalin on CRLF may be underestimated. 6.2.4 Location of Wildlife Species For the terrestrial exposure analysis of this risk assessment, a generic bird or mammal was assumed to occupy either the treated field or adjacent areas receiving a treatment rate on the field. Actual habitat requirements of any particular terrestrial species were not considered, and it was assumed that species occupy, exclusively and permanently, the modeled treatment area. Spray drift model predictions suggest that this assumption leads to an overestimation of exposure to species that do not occupy the treated field exclusively and permanently. 6.2.5 Toxicity to Honeybees. Pendimethalin is rated as practically non-toxic to honeybees. The honeybee contact toxicity data is used as a surrogate assessment endpoint for all terrestrial invertebrates. Because the calculated exposure (TREX EEC for large and small insects) exceeds the highest tested dose, even though there were no mortalities at the highest dose, there is some residual uncertainty about potential effects to terrestrial invertebrates. This results in a May Affect determination, however, it is considered discountable. 7.0 Risk Conclusions In fulfilling its obligations under Section 7(a)(2) of the Endangered Species Act, the information presented in this endangered species risk assessment represents the best data currently available to assess the potential risks of pendimethalin to the CRLF and its designated critical habitat. Based on the best available information, the Agency makes a Likely to Adversely Affect/May Affect, determination for the CRLF from the use of pendimethalin. The Agency has determined that there is the potential for effects to CRLF designated critical habitat from the use of the chemical. All of the uses might affect the frog or its critical habitat. The LAA determination is from direct and indirect effects to CRLF from the use of pendimethalin. Given the LAA determination for the CRLF and potential effects to designated critical habitat, a description of the baseline status and cumulative effects for the CRLF is provided in Attachment 2. The LAA effects determination applies to those areas where it is expected that the pesticide's use will directly or indirectly affect the CRLF or its designated critical habitat. To determine this area, the footprint of pendimethalin's use pattern is identified, using land cover data that correspond to pendimethalin's use pattern. The spatial extent of the 117 ------- LAA effects determination also includes areas beyond the initial area of concern that may be impacted by runoff and/or spray drift. The identified direct and indirect effects and modification to critical habitat are anticipated to occur only for those currently occupied core habitat areas, CNDDB occurrence sections, and designated critical habitat for the CRLF that overlap with the initial area of concern plus at least 1000 feet from its boundary (refer to analysis in Section 5.1.4). It is assumed that non-flowing waterbodies (or potential CRLF habitat) are included within this area. In addition to the spray drift buffer, the results of the downstream dilution extent analysis result in a distance of 272 kilometers which represents the maximum continuous distance of downstream dilution from the edge of the initial area of concern (refer to analysis in Section 5.1.4). If any of these streams reaches flow into CRLF habitat, there is potential to affect either the CRLF or affect its habitat. These lotic aquatic habitats within the CRLF core areas and critical habitats potentially contain concentrations of pendimethalin sufficient to result in LAA determination or effects to critical habitat. Appendix K provides maps of the initial area of concern, along with CRLF habitat areas, including currently occupied core areas, CNDDB occurrence sections, and designated critical habitat. It is expected that any additional areas of CRLF habitat that are located at least 1000 ft (to account for offsite migration via spray drift) and 272 kilometers of stream distance (to account for downstream dilution) outside the initial area of concern may also be impacted and are part of the full spatial extent of the LAA and critical habitat effects determination. A summary of the risk conclusions and effects determinations for the CRLF and its critical habitat, given the uncertainties discussed in Section 6, is presented in Table 7.0-1 and Table 7-2. Table 7-1 Effects Determination Summary for Pendimethalin Use and the CRLF Assessment Endpoint Survival, growth, and/or reproduction of CRLF individuals Effects Determination 1 LAA1 Basis for Determination Potential for Direct Effects Aquatic-phase (Eggs, Larvae, and Adults): Acute LOCs were exceeded for fish or aquatic-phase amphibians Terrestrial-phase (Juveniles and Adults): Acute and chronic LOCs were exceeded for birds. The available toxicity data suggest that amphibians are less sensitive than birds to pendimethalin, and considering factors such as lower food intake of terrestrial phase amphibians relative to birds reduces EECs and RQs, but does not reduce RQs to levels that are below LOCs. Likely to adversely affect CRLF. Potential for Indirect Effects Aquatic prey items, aquatic habitat, cover and/or primary productivity: LOG is exceeded only for non-vascular aquatic plants. RQs are below LOG for freshwater invertebrates (chronic and acute effects) and fish or frogs (chronic and acute effects). Pendimethalin could potentially impact terrestrial and aquatic plants to an extent that could result in indirect effects to the CRLF or modification of critical habitat. Terrestrial prey items, riparian habitat: 118 ------- Assessment Eiulpoint Effects Determination 1 Basis for Determination Chronic LOG is exceeded for mammal and birds (surrogate for frog). Pendimethalin is practically non-toxic to honeybees with no mortalities observed in testing. LOG is exceeded for terrestrial invertebrates. Uncertainty in toxicity to insects from EEC that is above highest bee concentration tested does not preclude potential risk. Pendimethalin may adversely affect insects. Acute LOCs were not exceeded for insectivorous amphibians using the T-HERPS model at the highest rate of application. LOG is exceeded for non-target terrestrial plants and thereby critical habitat could be affected as a result of these potential impacts. 1 No effect (NE); May affect, but not likely to adversely affect (NLAA); May affect, likely to adversely affect (LAA) Table 7-2 Effects Determination Summary for Pendimethalin Use and CRLF Critical Habitat Impact Analysis Assessment Endpoint Effects Determination Basis for Determination Modification of aquatic-phase PCE Habitat Effects Effects to riparian vegetation (terrestrial plants) and aquatic non-vascular and vascular plants result in LOG exceedances. These effects may indirectly affect the CRLF via reduction in food supply, changes in available cover, physical parameters of the waterbody (e.g. increase temperature or turbidity) LOG is exceeded for effects to non-vascular aquatic plants, freshwater invertebrates (chronic and acute effects) and fish or frogs (chronic and acute effects). Modification of terrestrial-phase PCE Effects to riparian vegetation (terrestrial plants) result in LOG exceedances. Effects may result in changes in community composition or relative abundance of riparian plant species, possibly altering terrestrial - phase CRLF habitat. Chronic LOG is exceeded for mammal. Although there are NLAA determinations for other prey items, small mammals constitute up to half of the food intake for CRLF and reduction in small mammalian populations may be significant. Based on the conclusions of this assessment, a formal consultation with the U. S. Fish and Wildlife Service under Section 7 of the Endangered Species Act should be initiated. When evaluating the significance of this risk assessment's direct/indirect and habitat effects determinations, it is important to note that pesticide exposures and predicted risks to the species and its resources (i.e., food and habitat) are not expected to be uniform across the action area. In fact, given the assumptions of drift and downstream transport (i.e., attenuation with distance), pesticide exposure and associated risks to the species and its resources are expected to decrease with increasing distance away from the treated field or site of application. Evaluation of the implication of this non-uniform distribution of risk to the species would require information and assessment techniques that are not currently available. Examples of such information and methodology required for this type of analysis would include the following: • Enhanced information on the density and distribution of CRLF life stages within specific recovery units and/or designated critical habitat within the action area. This information would allow for quantitative extrapolation of the present risk 119 ------- assessment's predictions of individual effects to the proportion of the population extant within geographical areas where those effects are predicted. Furthermore, such population information would allow for a more comprehensive evaluation of the significance of potential resource impairment to individuals of the species. Quantitative information on prey base requirements for individual aquatic- and terrestrial-phase frogs. While existing information provides a preliminary picture of the types of food sources utilized by the frog, it does not establish minimal requirements to sustain healthy individuals at varying life stages. Such information could be used to establish biologically relevant thresholds of effects on the prey base, and ultimately establish geographical limits to those effects. This information could be used together with the density data discussed above to characterize the likelihood of adverse effects to individuals. Information on population responses of prey base organisms to the pesticide. Currently, methodologies are limited to predicting exposures and likely levels of direct mortality, growth or reproductive impairment immediately following exposure to the pesticide. The degree to which repeated exposure events and the inherent demographic characteristics of the prey population play into the extent to which prey resources may recover is not predictable. An enhanced understanding of long-term prey responses to pesticide exposure would allow for a more refined determination of the magnitude and duration of resource impairment, and together with the information described above, a more complete prediction of effects to individual frogs and potential modification to critical habitat. 120 ------- 8.0 References Alvarez, J. 2000. Letter to the U.S. Fish and Wildlife Service providing comments on the Draft California Red-legged Frog Recovery Plan. Crawshaw, GJ. 2000. Diseases and Pathology of Amphibians and Reptiles in: Ecotoxicology of Amphibians and Reptiles; ed: Sparling, D.W., G. Linder, and C.A. Bishop. SETAC Publication Series, Columbia, MO. Fellers, G. M., et al. 2001. Overwintering tadpoles in the California red-legged frog (Rana aurora draytonif). Herpetological Review, 32(3): 156-157. Fellers, G.M, L.L. McConnell, D. Pratt, S. Datta. 2004. Pesticides in Mountain Yellow- Legged Frogs (Rana Mucosa) from the Sierra Nevada Mountains of California, USA. Environmental Toxicology & Chemistry 23 (9):2170-2177. Fellers, Gary M. 2005a. Rana draytonii Baird and Girard 1852. California Red-legged Frog. Pages 552-554. hr. M. Lannoo (ed.) Amphibian Declines: The Conservation Status of United States Species, Vol. 2: Species Accounts. University of California Press, Berkeley, California, xxi+1094 pp. (http://www.werc.usgs.gov/pt-reves/pdfs/Rana%20draytonii.PDF) Fellers, Gary M. 2005b. California red-legged frog, Rana draytonii Baird and Girard. Pages 198-201. In: L.L.C. Jones, et al (eds.) Amphibians of the Pacific Northwest. xxi+227. Hayes, M.P. and M.M. Miyamoto. 1984. Biochemical, behavioral and body size differences between Rana aurora aurora and R. a. draytonii. Copeia 1984(4): 1018-22. Hayes and Tennant. 1985. Diet and feeding behavior of the California red-legged frog. The Southwestern Naturalist 30(4): 601-605. Jennings, M.R. and M.P. Hayes. 1985. Pre-1900 overharvest of California red-legged frogs (Rana aurora draytonii): The inducement for bullfrog (Rana catesbeiand) introduction. Herpetological Review 31(1): 94-103. Jennings, M.R. and M.P. Hayes. 1994. Amphibian and reptile species of special concern in California. Report prepared for the California Department of Fish and Game, Inland Fisheries Division, Rancho Cordova, California. 255 pp. LeNoir, J.S., L.L. McConnell, G.M. Fellers, T.M. Cahill, J.N. Seiber. 1999. Summertime Transport of Current-use pesticides from California's Central Valley to the Sierra Nevada Mountain Range,USA. Environmental Toxicology & Chemistry 18(12): 2715-2722. 121 ------- McConnell, L.L., J.S. LeNoir, S. Datta, J.N. Seiber. 1998. Wet deposition of current-use pesticides in the Sierra Nevada mountain range, California, USA. Environmental Toxicology & Chemistry 17(10):1908-1916. Rathburn, G.B. 1998. Rana aurora draytonii egg predation. Herpetological Review, 29(3): 165. Reis, D.K. Habitat characteristics of California red-legged frogs {Rana aurora draytonii}: Ecological differences between eggs, tadpoles, and adults in a coastal brackish and freshwater system. M.S. Thesis. San Jose State University. 58 pp. D.W. Sparling, G.M. Fellers, L.L. McConnell. 2001. Pesticides and amphibian population declines in California, USA. Environmental Toxicology & Chemistry 20(7): 1591-1595. U.S. Environmental Protection Agency (U.S. EPA). 1998. Guidance for Ecological Risk Assessment. Risk Assessment Forum. EPA/630/R-95/002F, April 1998. U.S. EPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs. Office of Prevention, Pesticides, and Toxic Substances. Office of Pesticide Programs. Washington, D.C. January 23, 2004. U.S. Fish and Wildlife Service (USFWS). 1996. Endangered and threatened wildlife and plants: determination of threatened status for the California red-legged frog. Federal Register 61(101):25813-25833. USFWS. 2002. Recovery Plan for the California Red-legged Frog (Rana aurora draytonii). Region 1, USFWS, Portland, Oregon. (http://ecos.fws.gov/doc/recovery_plans/2002/020528.pdf) USFWS. 2006. Endangered and threatened wildlife and plants: determination of critical habitat for the California red-legged frog. 71 FR 19244-19346. USFWS. Website accessed: 30 December 2006. http://www.fws.gov/endangered/features/rl_frog/rlfrog.html #where U.S. Fish and Wildlife Service (USFWS) and National 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. USFWS/NMFS. 2004. 50 CFR Part 402. Joint Counterpart Endangered Species Act Section 7 Consultation Regulations; Final Rule. FR 47732-47762. 122 ------- Vogel, J.R., Majewski, M.S., and Capel, P.O. (2008) Pesticides in Rain in Four Agricultural Watersheds in the United States. J. Environ. Qual. V. 37 May-June 2008, pp. 1101-1115. 123 ------- |