Risks of BROMACIL and
BROMACIL LITHIUM Use to the Federally
     Listed California Red-Legged Frog
            (Rana aurora draytonii)
          Pesticide Effects Determination
      Environmental Fate and Effects Division
           Office of Pesticide Programs
             Washington, D.C. 20460
                October 19,2007

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Primary Authors
Kristina Garber, Biologist
Cheryl A. Sutton, Ph. D., Environmental Scientist

Reviewers
Thomas Steeger, Ph.D., Senior Biologist
Marietta Echeverria, RAPL

Branch Chief, Environmental Risk Branch 4
Elizabeth Behl

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Acknowledgement

The bromacil chemical team would like to acknowledge the contribution of the California
Red-Legged  Frog  Steering  Committee  in  compiling  detailed  information  on  the
threatened  species.   Additionally, the  Steering Committee  has  provided invaluable
guidance toward achieving greater consistency in format and content between chemicals
being assessed. We acknowledge the contribution of Mr.  Kurt Pluntke in providing the
Geographic  Information System  analysis used to define the  potential  overlap between
California red-legged frog and their designated critical habitat with the action area.

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Table of Contents


ACKNOWLEDGEMENT	3

TABLE OF CONTENTS	4

1.    EXECUTIVE SUMMARY	8

2.    PROBLEM FORMULATION	14

  2.1     PURPOSE	14
  2.2     SCOPE	16
  2.3     PREVIOUS ASSESSMENTS	18
  2.4     STRESSOR SOURCE AND DISTRIBUTION	18
     2.4.1   Environmental Fate Assessment	18
     2.4.2   Environmental Transport Assessment	21
     2.4.3   Mechanism of Action	22
     2.4.4   Use Characterization	22
  2.5     ASSESSED SPECIES	25
     2.5.7   Distribution	25
     2.5.2   Reproduction	31
     2.5.3   Diet	32
     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 Endpointsfor 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	44
  2.10 ANALYSIS PLAN	48
     2.10.1. Measures to Evaluate the Risk Hypothesis and Conceptual Model	49
     2.10.2. Data Gaps	52

3. EXPOSURE ASSESSMENT	54

  3.1. AQUATIC EXPOSURE ASSESSMENT	54
     3.1.1. Existing Water Monitoring Data for California	54
     3.1.2. Modeling Approach	55
     3.1.3. Aquatic Modeling Results	60
  3.2. TERRESTRIAL EXPOSURE ASSESSMENT	60
     3.2.1. Exposure to Plants	60
     3.2.2. Exposures to animals	61
     3.2.3. Spray Drift Modeling	62

4.    EFFECTS ASSESSMENT	64

  4.1. EVALUATION OF AQUATIC ECOTOXICITY STUDIES FOR BROMACIL	65
     4.1.1. Toxicity to freshwater fish	67
     4.1.2. Toxicity to freshwater invertebrates	67
     4.1.3. Toxicity to aquatic plants	68
  4.2. EVALUATION OF TERRESTRIAL ECOTOXICITY STUDIES FOR BROMACIL	69
     4.2.1. Toxicity to birds	 72
     4.2.2. Toxicity to mammals	 73
     4.2.3. Toxicity to terrestrial insects	 73
     4.2.4. Toxicity to terrestrial plants	 73
  4.3. INCIDENT REPORTS	74

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5.    RISK CHARACTERIZATION	78

   5.1. RISK ESTIMATION	78
     5.7.7. Exposures in the Aquatic Habitat	 78
     5.1.2. Exposures in the Terrestrial Habitat	80
   5.2. RISK DESCRIPTION	82
     5.2.1. Direct Effects	83
     5.2.2. Indirect Effects (through effects to prey)	88
     5.2.3. Indirect Effects (through effects to habitat)	93
     5.2.4. Primary Constituent Elements of Designated Critical Habitat	94
     5.2.5. Action Area	96
     5.2.6. Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps	 101
     5.2.7. Addressing the Risk Hypotheses	 109

6. CONCLUSIONS	110

PREFERENCES	112
Appendices

Appendix A. Pesticide Products Formulated with Bromacil and Other Pesticide Active Ingredients
Appendix B. PRZM/EXAMS Inputs and Outputs and results of non-cropland refinements
Appendix C. Outputs from TerrPlant vl.2.2
Appendix D. Outputs from T-REX v. 1.3.1
Appendix E. Outputs from T-HERPS v.1.0
Appendix F. The Risk Quotient Method and Levels of Concern
Appendix G. List of citations accepted and rejected by ECOTOX criteria
Appendix H. Detailed analysis of final bromacil/bromacil lithium action area and overlap of action area
with CRLF core areas and critical habitat
Attachments

Attachment 1: Status and Life History of California Red-legged Frog
Attachment 2: Baseline Status and Cumulative Effects for the California Red-legged Frog

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List of Figures

Figure 1. Historical (2002) extent of bromacil use in agricultural areas	24
Figure 2. Recovery Unit, Core Area, Critical Habitat, and Occurrence Designations for CRLF	30
Figure 3. CRLF Reproductive Events by Month	31
Figure 4. Initial action area for crops described by orchard and vineyard landcover which corresponds to
potential bromacil use sites on citrus.  This map represents the area potentially directly affected by the
federal action	37
Figure 5. Initial action area for crops described by right-of-way landcover which corresponds to potential
bromacil and bromacil lithium use sites on (some) non-cropland areas. This map represents the area
potentially directly affected by the federal action	38
Figure 6. Conceptual Model for Pesticide Effects on Aquatic Phase of the Red-Legged Frog	45
Figure 7. Conceptual Model for Pesticide Effects on Terrestrial Phase of Red-Legged Frog	46
Figure 8. Conceptual Model for Pesticide Effects on Aquatic Components of Red-Legged Frog Critical
Habitat	47
Figure 9. Conceptual Model for Pesticide Effects on Terrestrial Components of Red-Legged Frog Critical
Habitat	48
Figure 10. Final action area for crops  described by the orchard/vineyard landcover which corresponds to
potential bromacil use on citrus. This  map represents the area potentially directly and indirectly affected by
the federal action	98
Figure 11. Final action area for crops  described by right-of-way landcover which corresponds to potential
bromacil and bromacil lithium use sites on non-cropland areas. This map represents the area potentially
directly and indirectly affected by the federal action	99


List of Tables

Table 1. Effects Determination Summary for the CRLF based on bromacil use on citrus	11
Table 2. Effects Determination Summary for the CRLF based on bromacil and bromacil lithium use on
non-cropland areas	12
Table 3. Chemical identities of bromacil and bromacil lithium	19
Table 4. Summary of environmental chemistry, fate and transport  properties of bromacil	20
Table 5. Uses and maximum use rates of bromacil and bromacil lithium	23
Table 6. California Red-legged Frog Recovery Units with Overlapping Core  Areas and Designated Critical
Habitat	28
Table 7. Summary of Assessment Endpoints and Measures of Ecological Effects for Direct and Indirect
Effects of bromacil and bromacil lithium on the California Red-legged Frog	40
Table 8. Summary of Assessment Endpoints and Measures of Ecological Effect for Primary Constituent
Elements of Designated Critical Habitat	42
Table 9. Agency risk quotient (RQ) metrics and levels of concern  (LOG) per risk class	52
Table 10. NAWQA 1993 - 2005 data  for bromacil detections u in CA SURFACE waters. Data are
distinguished by the  landcover (e.g. agricultural, urban, etc.) of the watershed of the sampled water bodies.
	54
Table 11. NAWQA 1993 - 2005 data  for bromacil detections u in CA GROUND waters. Data are
distinguished by the  landcover (e.g. agricultural, urban, etc.) of the watershed of the sampled water bodies.
	55
Table 12. Chemical specific PRZM/EXAMS Input Parameters for deriving aquatic EECs for bromacil... 58
Table 13. Use-specific PRZM/EXAMS Input Parameters for deriving aquatic EECs for bromacil	58
Table 14. Aquatic EECs from PRZM/EXAMS modeling for maximum application rates of bromacil. EECs
are based on the appropriate PRZM scenario and the standard EXAMS pond	60
Table 15. TerrPlant inputs and resulting EECs for plants  inhabiting dry and semi-aquatic areas exposed to
bromacil through runoff and drift	60
Table 16. Input parameters for T-REX used to derive terrestrial EECs for bromacil	61
Table 17. Upper-bound Kenega nomogram EECs for exposures of the CRLF  and its prey to bromacil	61
Table 18. Distance away from edge of field where terrestrial animal and plant LOCs are not exceeded by
exposures to bromacil through spray drift	62

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Table 19. Scenario and standard management input parameters for simulation of bromacil in spray drift
using AgDisp with Gaussian farfield extension	63
Table 20. Summary of most sensitive toxicity for assessing direct and indirect effects of bromacil to CRLF
in aquatic habitats	66
Table 21. Categories of Acute Toxicity for Aquatic Animals	66
Table 22. EC50 and NOAEC values from registrant submitted studies involving exposures of bromacil to
unicellular, aquatic plants	69
Table 23. Summary of most sensitive toxicity for assessing direct and indirect effects of bromacil to CRLF
in terrestrial habitats	70
Table 24. Categories for mammalian acute toxicity based on median lethal dose in mg per kilogram body
weight (parts per million)	71
Table 25. Categories of avian acute oral toxicity based on median lethal dose in milligrams per kilogram
body weight (parts per million)	71
Table 26. Categories of avian subacute dietary toxicity based on median lethal concentration in milligrams
per kilogram diet per day (parts per million)	71
Table 27. Comparison of seedling emergence endpoints1 for wheat and rape exposed to bromacil and
bromacil lithium	74
Table 28. Comparison of vegetative vigor endpointsl for wheat and rape exposed separately to bromacil
and bromacil lithium	74
Table 29. Summary of reported incidents involving terrestrial plants in relation to applications of bromacil.
	76
Table 3 0. Summary of reported incidents involving fish kills in relation to applications of bromacil	77
Table 31. RQ values for acute and chronic exposures directly to the CRLF in aquatic habitats	79
Table 32. RQ values for exposures to unicellular aquatic plants (diet of CRLF in tadpole life stage)	79
Table 33. Risk Quotient (RQ) values for acute and chronic exposures to aquatic invertebrates (prey of
CRLF juveniles and adults) in aquatic habitats	79
Table 34. RQ values for exposures of aquatic plants to bromacil	80
Table 35. RQ values for exposures of terrestrial-phase CRLF to bromacil. RQs  estimated using T-REX.. 80
Table 36. RQ values for exposures of terrestrial animals to bromacil. RQs estimated using T-REX	81
Table 37. RQ values for exposures of terrestrial plants to bromacil. RQs estimated using TerrPlant	82
Table 38. RQ values for acute and chronic exposures directly to the CRLF in aquatic habitats resulting
from applications of bromacil and bromacil lithium to non-cropland areas at the maximum uses allowed by
labels	84
Table 39. Dietary-based and dose-based EECs relevant to direct effects to the CARLF through
consumption of prey contaminated by bromacil. Modeling done with T-HERPS	85
Table 40. Acute and chronic, dietary-based RQs and dose-based RQs for direct effects to the terrestrial-
phase CRLF, based on bromacil exposures resulting from applications to citrus. RQs calculated using T-
HERPS	86
Table 41. Acute and chronic, dietary-based RQs and dose-based RQs for direct effects to the terrestrial-
phase CRLF, based on bromacil exposures resulting from bromacil applications to non-cropland areas (max
rate = 2 applications of 15.4 Ibs a.i./A). RQs calculated using T-HERPS	87
Table 42. Acute and chronic, dietary-based RQs and dose-based RQs for direct effects to the terrestrial-
phase CRLF, from bromacil lithium applications to non-cropland  areas (max rate = 1 application of 12 Ibs
a.i./A). RQs calculated using T-HERPS	87
Table 43. Species specific RQs for unicellular aquatic plants	89
Table 44. RQ values for exposures of terrestrial frogs (prey of CRLF) to bromacil. RQs estimated using T-
HERPS	92
Table 45. Quantitative results of spatial analysis of lotic aquatic action area relevant to bromacil	96
Table 46. Overlap between CRLF habitat (core areas and critical habitat) and citrus action area by recovery
unit(RU#)	100
Table 47. Overlap between CRLF habitat (core areas and critical habitat) and non-cropland action area by
recovery unit (RU#)	100

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1.     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 bromacil and its salt, bromacil lithium, on agricultural
and non-agricultural sites.  In addition, this assessment evaluates whether these actions
can be expected to result in modification of 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.

This assessment considers registrations of bromacil, as well as bromacil lithium, which
dissociates  to  form bromacil.  Bromacil and bromacil lithium are currently registered
herbicides for use  on non-cropland  areas, including (but not necessarily  limited to)
airports,  parking lots, industrial areas, rights-of-way (for railroads, highways, pipeline
and  utilities), storage  areas, lumberyards,  tank  farms,  under asphalt  and  concrete
pavement and fence rows. These chemicals can also be used in uncultivated  portions of
agricultural areas, including farmyards, fuel storage areas, fence rows  and barrier strips.
In addition, bromacil is registered for use in citrus orchards and pineapple  fields. The
maximum use rates of bromacil and bromacil lithium  on non-cropland areas are 2
applications per year of 15.4 Ibs a.i./A and 1  application per year  of 12 Ibs a.i./A,
respectively. The maximum use rate of bromacil on citrus orchards is 1 application per
year of 6.4 Ibs a.i./A.  All  exposure modeling and resulting risk conclusions are made
based on these maximum application rates.

In this  assessment, it  is assumed that uses  of bromacil and bromacil  lithium could
potentially result in exposures of bromacil to aquatic and terrestrial habitats of the CRLF.
In this assessment, when uses of non-cropland areas are discussed, bromacil and bromacil
lithium are considered. Since  bromacil lithium dissociates in water to form bromacil, this
assessment refers to exposures resulting from non-cropland uses in terms of bromacil.
Fate and effects data for bromacil are considered relevant for both bromacil and bromacil
lithium.

The environmental fate properties of bromacil along with monitoring data identifying its
presence in surface waters and ground waters in California indicate  that bromacil has the
potential to be transported to non-target areas. In this assessment, transport of bromacil
from initial application sties  through  runoff and  spray drift are considered in deriving
quantitative estimates of bromacil exposure to CRLF, its prey and its habitats.

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Since CRLFs exist within aquatic and terrestrial habitats, exposure of the CRLF, its prey
and its habitats to bromacil are assessed separately for the two habitats. Tier-II exposure
models (PRZM/EXAMS) are used to estimate high-end exposures of bromacil in aquatic
habitats resulting from runoff and spray drift from different uses. Peak model-estimated
environmental concentrations resulting from maximum label rates  of bromacil for citrus
and non-agricultural uses are 0.050 and 2.34 mg/L, respectively, in  aquatic habitats.
These estimates are 1-3 orders of magnitude greater than the maximum concentration of
bromacil  (0.0075  mg/L) measured in non-targeted  monitoring in California surface
waters.

To estimate bromacil exposures to terrestrial-phase CRLF, and its potential prey resulting
from uses involving maximum application rates of bromacil or bromacil lithium, the T-
REX  model is  used. To further characterize  exposures of terrestrial-phase CRLF to
dietary-  and dose-based exposures of  bromacil,  T-HERPS is used.  AgDRIFT  and
AGDISP  are also  used to estimate deposition of bromacil on terrestrial habitats from
spray drift. To  estimate bromacil exposures to  terrestrial-phase habitat, including plants
inhabiting semi-aquatic and dry areas, the TerrPlant model is used.

The assessment endpoints for the  CRLF  include  direct toxic effects  on the survival,
reproduction, and  growth of the aquatic- and  terrestrial-phase CRLF  itself, as well as
indirect effects, such as reduction  of the prey base and/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.

Bromacil  is slightly toxic to freshwater fish  and practically  non-toxic to freshwater
invertebrates on an acute exposure basis. Toxicity categories  for aquatic plants have not
been defined. If classification for animals were  applied to aquatic plants, bromacil would
be classified very highly toxic to unicellular and vascular plants.   The NOAECs for the
fathead minnow and waterflea  are 3.0  and 8.2 mg a.i./L, respectively.   Bromacil is
practically nontoxic to birds and slightly toxic  to mammals on an acute exposure basis.
Chronic exposures to bobwhite quail in reproduction studies indicate reproductive effects
(embryo viability and  survival,  hatchability and  hatchling survival) with a NOAEC of
1500  mg/kg-diet/day.  Chronic  exposures  to rats  in a  reproduction  study indicate  a
NOAEL for body  weight reductions  of 250 mg/kg-diet/day.  Seedling emergence  and
vegetative vigor studies with wheat (a monocot) result in EC25 values of 0.030 and 0.042
Ibs a.i./A, respectively. Seedling emergence and vegetative  vigor studies with rape (a
dicot) result in EC25 values of 0.0047 and 0.0055 Ibs a.i./A, respectively.

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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)  for
Federally-listed threatened species to identify if bromacil or bromacil lithium use within
the action  area has  any  direct or indirect effect on the CRLF.   Based  on estimated
environmental concentrations for the currently registered uses of bromacil or bromacil
lithium, RQ values are above the Agency's LOG for direct acute effects on the CRLF
resulting from  applications to  citrus and non-cropland areas; this represents a "may
affect" determination. RQs for uses on citrus and non-cropland areas exceed the LOG for
exposures to aquatic  unicellular plants. Therefore, there is a potential to indirectly affect
larval (tadpole) CRLF due to  effects to the algae forage base in aquatic  habitats.  The
effects determination for indirect effects to the CRLF due to  effects to its prey base is
"may affect." When considering the prey of larger CRLF in terrestrial habitats (e.g. frogs,
fish and small mammals), RQs for some of these taxa also exceed the LOG  for acute and
chronic exposures, resulting in a "may affect" determination.  RQ values  for plants in
aquatic and terrestrial habitats exceed the  LOG; therefore, indirect effects  to the CRLF
through effects on aquatic and terrestrial habitats result in a "may affect" determination.

All "may affect" determinations are further refined using available evidence to determine
whether they are "not likely to adversely affect" (NLAA) or "likely to adversely affect"
(LAA).  Additional  evidence is employed  to distinguish between NLAA and LAA
determinations.  This evidence  includes  available monitoring data  and likelihood  of
individual mortality analysis.

Refinement of all "may affect" determinations from bromacil use on citrus results  in a
"NLAA"  determination  for  direct effects to the CRLF,  a "LAA" determination  for
indirect effects to the CRLF based on effects to its prey, specifically algae, and a "LAA"
determination for indirect effects to the CRLF based on effects to aquatic and terrestrial
habitat (Table  1). Consideration of CRLF critical habitat indicates a determination of
"habitat modification" for aquatic and terrestrial habitats based on bromacil use on citrus.
The overall CRLF effects determination  for bromacil use on citrus is "LAA."

Refinement of all "may affect" determinations from bromacil and bromacil lithium  use
on non-cropland areas result in a "LAA" determination for direct effects to the CRLF, a
"LAA"  determination for indirect effects to the CRLF  based on  effects to its prey,
specifically algae, and a "LAA" determination for indirect effects to the CRLF based on
effects to aquatic and terrestrial habitat (Table 2). Consideration of CRLF critical habitat
indicates a determination of "habitat modification" for aquatic and terrestrial habitats
based on non-cropland uses of bromacil and bromacil lithium. The overall CRLF effects
determination  for  bromacil  and bromacil lithium  use  on non-cropland areas is
"LAA."

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.
                                        10

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  Table 1. Effects Determination Summary for the CRLF based on bromacil use on citrus.
  Assessment I ml point
    Effects
Determination1
                                                                                                                Basis for Determination
  Direct effects to CRLF
                                 NLAA
                                                - Acute and chronic RQs for CRLF in aquatic habitats do not exceed the listed species LOG, therefore, the risk of bromacil exposures to CRLF in this habitat is low.
                                                -Dose-based and dietary-based acute RQs for the terrestrial phase CRLF are indiscreet because dose-based and dietary-based studies did not quantify LD50 and LC50
                                                values (respectively), which were greater than the highest concentrations tested.
                                                -Refined RQs (using T-HERPS) indicates a potential LOG exceedance for medium sized (37g) terrestrial-phase CRLF consuming small herbivore mammals (based on
                                                acute, dose based exposures). No other dose-based RQs exceed the LOG for CRLF of other feeding categories. Risk of mortality and sublethal effects to the CRLF is
                                                unlikely  since comparison  of EECs to the lowest concentration where  sublethal  effects were observed in an acute  oral study with birds indicates that exposure
                                                concentrations are insufficient to reach levels where sublethal effects were observed.
                                                -RQ for acute, dietary-based exposure to the terrestrial phase CRLF does not exceed LOG.
                                                -RQ for chronic exposure of the terrestrial phase CRLF to bromacil does not exceed listed species LOG.
 Indirect effects to tadpole
  CRLF via reduction of
          prey
        (i.e., algae)
                                  LAA
                   -RQ exceeds LOG by>8x.
                   - According to available toxicity data for 4 species of unicellular aquatic plants, EECs are sufficient to exceed the LOG for 3 of 4 species.
                   - Non-target monitoring data are at levels sufficient to exceed the LOG for unicellular aquatic plants.
                   - Exposures of bromacil in aquatic habitats have the potential to affect populations and possibly communities of aquatic algae.
 Indirect effects to juvenile
  CRLF via reduction of
  prey (i.e., invertebrates)
                                 NLAA
                   - Aquatic Invertebrates: Acute and chronic RQs do not exceed LOG, indicating low risk of mortality to these organisms.
                   - Terrestrial Invertebrates: RQs for small and large insects potentially exceed the LOG. RQs are indiscreet because the  available acute toxicity study did not quantify
                   LD50. Direct comparison of the level were 1.2% mortality was observed with EECs calculated by T-REX for small and large insects exposed to bromacil applied to
                   citrus, the EECs are insufficient to reach the level where 1.2% mortality was observed in honey bees.  Indirect effects to the CRLF  due to  effects to terrestrial
                   invertebrates are insignificant.
  Indirect effects to adult
  CRLF via reduction of
          prey
  (i.e., invertebrates, fish,
       frogs, mice)
                                 NLAA
                   - Aquatic Invertebrates: Acute and chronic RQs do not exceed LOG, indicating low risk of mortality to these organisms.
                   - Terrestrial Invertebrates: RQs for small and large insects potentially exceed the LOG. RQs are indiscreet because the  available acute toxicity study did not quantify
                   LD50. Direct comparison of the level were 1.2% mortality was observed with EECs calculated by T-REX for small and large insects exposed to bromacil applied to
                   citrus, the EECs are insufficient to reach the level where 1.2% mortality was observed in honey bees.  Indirect effects to the CRLF  due to  effects to terrestrial
                   invertebrates are insignificant.
                   - Fish and aquatic-phase frogs: Acute and chronic RQs do not exceed listed species LOG for fish and aquatic-phase amphibians, indicating low risk of mortality to
                   these organisms.
                   - Terrestrial-phase frogs: For terrestrial frogs serving as CRLF prey, refined EECs from T-HERPS result in  RQs which are insufficient to exceed acute and chronic
                   listed species LOCs.
                   - Mice:  Acute RQ exceeds listed species LOG by 8.2X for small terrestrial mammals consuming short grass. Exposures up to  23 feet beyond the edge  of the citrus
                          orchard are sufficient to exceed the LOG. The likelihood of individual mortality for mice directly on the field is 34.5%.
                           -Chronic RQ exceeds listed species LOG by 6.1 to 53X  for small terrestrial mammals consuming short grass. Chronic exposures  (dose-based) up to 132 feet
                           beyond the  edge of the citrus orchard are sufficient to exceed the  LOG. Chronic EECs are sufficient to exceed the LOAEC  concentration for the available
                           chronic mammalian toxicity study.
                   - Summary: Because the adult CRLF is an opportunistic feeder, it will consume available prey. Since effects are not expected for the majority of its possible prey items
                   (4 of 5), it is expected that there will be sufficient prey to maintain  the adult CRLF. Potential effects to mice are considered insignificant to the adult CRLF, when
                   considering its entire diet.
 Indirect effects to CRLF
  via reduction of habitat
      and/or primary
       productivity
       (i.e., plants)
                                  LAA
                   -RQs for plants inhabiting acute and terrestrial habitats exceed LOG by several orders of magnitude.
                   -For terrestrial dicots, spray drift exposures up to 4026 feet (0.76 miles) beyond the edge of the citrus orchard are sufficient to exceed the LOG.
                   -Several ecological incidents have been reported related to effects of runoff of bromacil to non-target plants.
                   -Bromacil is an herbicide, and is expected to cause effects to plants.
'LAA = likely to adversely affect; NLAA = not likely to adversely affect; NE = no effect
                                                                                                   11

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  Table 2. Effects Determination Summary for the CRLF based on bromacil and bromacil lithium use on non-cropland areas.
 Assessment I  ml point
    Effects
Determination1
                                                                                                                Basis for Determination
 Direct effects to CRLF
                                  LAA
                                                - Acute aquatic RQs for the maximum use rate of bromacil on rights of ways and impervious surfaces exceed the listed species LOG. The likelihood of individual
                                                mortality to a CRLF individual is 1 in 2.17e7. Since the chance of this occurring is approximately 0.000005%, potential direct effects are insignificant. Therefore, the
                                                risk of bromacil exposures to CRLF in this habitat is low.
                                                - Acute  aquatic RQs that result from the maximum use rate of bromacil lithium are insufficient to exceed the listed species LOG.
                                                - The chronic aquatic RQ does not exceed listed species LOG.
                                                - Dose-based and dietary-based acute RQs for the terrestrial phase CRLF are indiscreet because dose-based and dietary-based studies did not quantify LD50 and LC50
                                                values (respectively), which were greater than the highest concentrations tested.
                                                - Refined RQs (using  T-HERPS) indicates potential LOG exceedances  for several  feeding categories and  body sizes  of CRLF when considering applications of
                                                bromacil and bromacil lithium at their respective maximum use rates.
                                                - Comparison of EECs to effects  observed in acute tests indicated that EECs exceed levels where sublethal effects and mortality (20%) were observed. Therefore, there
                                                is potential for direct effects to the terrestrial-phase CRLF resulting from acute exposures.
                                                - For chronic exposures of the CRLF in the terrestrial  habitat, the LOG is exceeded for applications of bromacil, specifically for CRLF feeding on small insects and on
                                                small herbivore mammals. Chronic  RQs for bromacil lithium applications also exceed the LOG. Direct comparison of chronic dietary-based EECs resulting from
                                                bromacil applications to the chronic avian reproduction study LOAEC indicate that EECs are sufficient to exceed the level where reproductive effects were observed in
                                                birds.
                                                - Acute  effects directly to terrestrial-phase CRLF resulting from bromacil and bromacil lithium applications at the maximum allowed rates to and to non-cropland areas
                                                cannot be discounted.
                                                - At the maximum use rate of bromacil, there is potential for risk directly to the terrestrial-phase CRLF based on chronic exposures.
Indirect effects to tadpole
 CRLF via reduction of
    prey (i.e., algae)
                                  LAA
                    -RQ exceeds LOC by>300x.
                    - According to available toxicity data for 4 species of unicellular aquatic plants, EECs are sufficient to exceed the LOC for 4 of 4 species.
                    - Non-target monitoring data are at levels sufficient to exceed the LOC for unicellular aquatic plants.
                    - Exposures of bromacil in aquatic habitats have the potential to affect populations and possibly communities of aquatic algae.
    Indirect effects to
   juvenile CRLF via
  reduction of prey (i.e.,
      invertebrates)
                                 NLAA
                    - Aquatic Invertebrates: Acute and chronic RQs do not exceed LOC, indicating low risk of mortality to these organisms.
                    - Terrestrial Invertebrates: Direct comparison of the level were 1.2% mortality was observed with EECs calculated by T-REX for large insects, indicates that EECs are
                    insufficient to reach the level where 1.2% mortality was observed in honey bees.  For small insects, EECs are approximately  3x the level where 1.2% mortality was
                    observed in honey bees.   It is expected that beyond the edge  of the application site, EECs will be below the  level where 1.2% mortality was observed in honey bees.
                    On application sites, use of bromacil on non-cropland areas could potentially result in mortality to >1.2% of small sized insects.  There is potential for effects to some
                    terrestrial invertebrates (small sized) representing CRLF prey;  however, it seems unlikely that large sized  terrestrial invertebrates will be  affected by bromacil
                    applications to non-cropland areas, leaving terrestrial invertebrates to serve as prey to terrestrial-phase CRLF.
 Indirect effects to adult
 CRLF via reduction of
 prey (i.e., invertebrates,
    fish, frogs, mice)
                                 NLAA
                    - Aquatic Invertebrates: Acute and chronic RQs do not exceed LOC, indicating low risk of mortality to these organisms.
                    - Terrestrial Invertebrates: There is potential for effects to some terrestrial invertebrates (small sized) representing CRLF prey; however, it seems unlikely that large
                    sized terrestrial invertebrates will be affected, leaving terrestrial invertebrates to serve as prey to terrestrial-phase CRLF.
                    - Fish and aquatic-phase frogs: The likelihood of individual mortality to an individual fish or frog is <0.001%. The chronic LOC is not exceeded.
                    - Terrestrial-phase frogs: For terrestrial frogs serving as CRLF prey, refined EECs from T-HERPS result in acute and chronic RQs which potentially exceed acute
                    listed species LOC.
                    - Mice:  Acute RQ exceeds listed species  LOC by 35X for small terrestrial mammals  consuming  short grass. Exposures  up to 771 feet beyond the edge of the
                            application site are sufficient to exceed the LOC. The likelihood of individual mortality for mice directly on the field is approximately 100%.
                            -Chronic RQ exceeds listed species LOC by 26 to 225X for small terrestrial mammals consuming short grass. Chronic exposures (dose-based) up to 3113 feet
                            beyond the edge of the site of application are sufficient to exceed the LOC. Chronic EECs are sufficient to exceed the LOAEC concentration for the available
                            chronic mammalian toxicity study.
                    - Summary: Because the adult CRLF is an opportunistic feeder, it will consume available prey.  Since effects are not expected for the majority of its possible prey items
                    (3 of 5), it is expected that there will be sufficient prey to  maintain the adult CRLF. Potential effects to mice and terrestrial  species of prey frogs are  considered
                    insignificant to the adult CRLF, when considering its entire diet.
 Indirect effects to CRLF
 via reduction of habitat
     and/or primary
 productivity (i.e., plants)
                                  LAA
                    -RQs for plants inhabiting acute and terrestrial habitats exceed LOC by several orders of magnitude.
                    -For terrestrial dicots, spray drift exposures up to 5909 feet (1.12 miles) beyond the edge of the application site are sufficient to exceed the LOC.
                    -Several ecological incidents have been reported related to effects of runoff of bromacil to non-target plants.
                    -Bromacil is an herbicide, and is expected to cause effects to plants.
'LAA = likely to adversely affect; NLAA = not likely to adversely affect; NE = no effect
                                                                                                  12

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When  evaluating the significance of this risk assessment's direct/indirect and habitat
modification 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
              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.
                                         13

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2.     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
bromacil and its lithium salt as an herbicide  on citrus and non-cropland areas, including
industrial  and right-of-way areas.  In addition,  this assessment evaluates whether these
actions can be expected to result in the modification of the species' critical habitat.  Key
biological information for the CRLF is included in Section 2.5,  and designated critical
habitat information for the species is provided  in Section 2.6 of this assessment.  This
ecological  risk  assessment has been  prepared as part of  the  Center for Biological
Diversity (CBD) vs.  EPA et al. (Case No. 02-1580-JSW(JL)) settlement entered in the
Federal District Court for the Northern District of California on October 20, 2006.

In this  endangered  species assessment,  direct and indirect effects  to  the  CRLF and
potential modification to its critical habitat are evaluated in accordance with the methods
(both screening level and species-specific refinements, when appropriate) described in
the Agency's Overview Document (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 bromacil and bromacil lithium are based on an action area.   The action
area is considered to be the area directly or  indirectly affected by the federal action, as
indicated by the exceedance of Agency Levels of Concern (LOCs) used to evaluate direct
or indirect effects.  It is acknowledged that  the action area for a national-level FIFRA
regulatory  decision  associated with a use of bromacil and  bromacil lithium  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 for registration  of bromacil and bromacil lithium  at the
                                        14

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use sites described in this document to affect  CRLF individuals  and/or  result in  the
modification of designated CRLF critical habitat:

          •   "No effect";
          •   "May affect, but not likely to adversely affect"; or
          •   "May affect and likely to  adversely affect".

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 CRLFs are aquatic and upland areas where suitable  breeding
and  non-breeding aquatic habitat  is located,  interspersed with upland foraging and
dispersal habitat (Section 2.6).

If the results  of initial  screening-level  assessment methods  show no direct  or indirect
effects (no LOG exceedances) upon individual CRLFs  or upon the PCEs of the species'
designated critical habitat, a "no effect"  determination is made for the FIFRA regulatory
action regarding bromacil and  bromacil  lithium as it relates to  this species and its
designated critical habitat. If, however,  direct or indirect effects to individual  CRLFs 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 bromacil and bromacil lithium.

If a determination is made that use of bromacil and bromacil lithium within the action
area(s) associated with the CRLF "may  affect" this species and/or its designated critical
habitat, additional information is considered to refine the potential for exposure and for
effects to the CRLF 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 bromacil  and bromacil lithium use  sites) and further
evaluation of the potential impact of bromacil and bromacil lithium on the PCEs are also
used to determine whether modification 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  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 bromacil and bromacil lithium  are expected to directly impact living organisms
within the action area (defined in Section 2.7), critical  habitat analyses for bromacil and
bromacil lithium are 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
                                        15

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PCEs and appreciably diminish the value of the habitat.  Evaluation of actions related to
use of bromacil and bromacil lithium 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

This assessment considers registrations of bromacil, as well as its salt, bromacil lithium,
which dissociates to form bromacil in water. Bromacil and bromacil lithium are currently
registered for  use as herbicides on non-cropland  areas,  including  (but not necessarily
limited to) airports, parking lots, industrial areas, rights-of-way (for railroads, highways,
pipeline and utilities), storage areas, lumberyards, tank farms, under asphalt and  concrete
pavement and  fence rows. These chemicals can also be used as herbicides in uncultivated
portions of agricultural areas, including farmyards, fuel  storage areas, fence rows and
barrier strips.  In addition, bromacil (but not bromacil lithium) is registered for use in
citrus orchards and pineapple fields.  Although labels allow applications  of bromacil to
pineapple, this crop is generally not grown in California and is therefore,  not  relevant to
this assessment (USDA 2007).

The end result of the EPA pesticide registration process (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 or granular), acceptable methods of application, approved
use sites, and  any restrictions on how applications may be conducted.  Thus, the use or
potential use of bromacil and bromacil lithium in accordance with the approved product
labels for California are "the actions" being assessed.

Although  current registrations  of   bromacil and  bromacil lithium  allow  for use
nationwide, this ecological risk assessment and effects determination addresses currently
registered uses of bromacil and bromacil lithium 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.

In this assessment,  it is  assumed  that uses of bromacil and bromacil  lithium could
potentially result in exposures of bromacil to aquatic and terrestrial habitats of the CRLF.
In this assessment, when uses of non-cropland areas are discussed, bromacil and bromacil
lithium are considered. Since bromacil lithium dissociates in water to form bromacil, this
assessment refers to  exposures resulting from non-cropland uses in terms of bromacil.
Fate and effects data  for bromacil are considered relevant for both bromacil and bromacil
lithium.

Consistent with what was done for the environmental fate and ecological risk assessment
in support of the reregi strati on eligibility decision on bromacil,  only parent bromacil (and
bromacil lithium) are included in this assessment.  Although bromacil  photodegrades
                                        16

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rapidly  at pH 9, information on photodegradates  is not available.  In soil, bromacil
degrades slowly (half-life  of 275 days),  and CC>2 is the only major degradate.  Five
aerobic  soil  minor degradates were identified, but were present at only 0.6-3.4% of total
residues.    The  major  and  persistent  anaerobic  aquatic degradate, 3-sec-butyl-6-
methyluracil (Metabolite F), which represented a maximum of 80.7% of the applied (day
304), was not determined to be of toxicological concern (Linda Taylor, HED/OPP) in the
bromacil RED.

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,  the
data 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).

Bromacil has registered products that contain multiple  active  ingredients,  including
diuron;  2,4-dichlorophenoxyacetic acid; sodium chlorate; sodium metaborate; and 2,4-
dichlorophenoxy)-2,ethylhexyl ester.  Analysis of the available acute oral mammalian
LDso data (and available open  literature for Bromacil) for multiple active ingredient
products relative to the single active ingredient are provided  in Appendix A. The results
of this  analysis show that an assessment based  on the toxicity of the  single active
ingredient of bromacil  or  bromacil lithium is  appropriately conservative  since  the
technical grade active ingredient is more toxic than the formulated end product.

This assessment considers  only  the single  active ingredients bromacil and bromacil
lithium.  However, the  assessed species and their environments may be exposed to
multiple pesticides simultaneously.  Interactions  of other  toxic agents with bromacil
could result in additive effects, synergistic effects  or antagonistic  effects. Evaluation of
pesticide mixtures is beyond the scope of this assessment because of the myriad factors
that cannot be quantified based on the available data. Those factors include identification
of other possible co-contaminants and their concentrations, differences in the pattern and
duration of exposure  among  contaminants,  and the differential  effects  of  other
physical/chemical  characteristics of the  receiving waters (e.g. organic matter present in
sediment  and  suspended  water).    Evaluation   of  factors  that   could  influence
additivity/synergism is beyond the scope of this assessment and is beyond the capabilities
of the available  data to allow for an evaluation. However, it is acknowledged that not
considering  mixtures could  over- or under-estimate risks depending  on the type  of
interaction and factors discussed above.
                                        17

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2.3    Previous Assessments

Bromacil  was first registered  as  an herbicide  in the U.S. in  1961.  EPA issued a
Registration Standard for bromacil in September 1982  (PB87-110276). In 1996, the
Agency completed a Reregi strati on Eligibility Decision (RED)  for bromacil  and its
lithium salt (USEPA 1996).

2.4    Stressor Source and Distribution

       2.4.1   Environmental Fate Assessment

The  environmental fate  database  for  bromacil  is largely  complete.   Bromacil is a
persistent  and mobile herbicide.   The  primary  routes of dissipation  appear to be
photolysis in water under alkaline conditions (pH 9) and microbial degradation under
anaerobic  conditions.  However, the photodegradates under alkaline conditions have not
been  defined,  and  the rate of degradation under anaerobic conditions  has not been
accurately determined.

In laboratory studies, bromacil was stable  to hydrolysis, photodegradation in water  at
pH's 5 and 7, and photodegradation on soil.  At pH 9, where an absorption spectrum shift
occurs, bromacil photodegraded fairly rapidly with  a half-life of 4-7 days.  However, the
radiolabeled residues in  the  pH  9 test  solution  was  not further characterized, so
degradates were not identified or quantified.

Microbial  degradation of bromacil in aerobic soil is slow, with a half-life of 275 days in a
silty clay  loam soil.  Carbon  dioxide was  the major degradate, totaling 40.3% of the
applied at  12 months posttreatment.

Bromacil  may be  expected to  degrade more  rapidly under anaerobic than  aerobic
conditions.  In an open-literature laboratory study, bromacil had an observed half-life of
144 to 198 days in Greenfield sandy loam soil under saturated (anaerobic) soil conditions
(Wolf, 1974).   However, since there is no acceptable guideline study a conservative
assumption of "stable to anaerobic  microbial degradation" is  used in this assessment for
modeling aquatic exposures.

In field studies, bromacil was very persistent, with dissipation half-lives  of 124-155 days
in the surface soil of bareground plots in Delaware and California, and detections in the
upper 10 cm of the plots through 538 and 415 days posttreatment, respectively.

Bromacil  accumulates  only  slightly  in  fish  and  depurates   rapidly.    Maximum
bioconcentration factors (BCF) were 4.6X for muscle, 6.8-8.3X for viscera, 2.1-2.2X for
carcass, and 2.5-2.8X for whole fish.   Depuration  was  rapid, with  >96%  of the
accumulated [14C]residues eliminated from the fish tissues by  day 3 of the depuration
period.
                                        18

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Table 3 summarizes the chemical identities of bromacil and bromacil lithium. Table 4
summarizes the environmental chemistry, fate and transport properties of bromacil.

Table 3. Chemical identities of bromacil and bromacil lithium.
PARAMETER
PC code
CAS No.
Chemical name
Chemical formula
Bromacil
012301
314-40-9
5-bromo-3-sec-butyl-6-methyluracil
C9H13BrN2O2
Bromacil lithium
012302
53404-19-6
5-bromo-3-sec-butyl-6-methyluracil, lithium
salt
C9H13BrN2O2Li+
                                       19

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Table 4. Summary of environmental chemistry, fate and transport properties of bromacil.
PARAMETER
VALUE
REFERENCE/
COMMENTS
Selected Physical/Chemical Parameters
Molecular weight
Water solubility (25 °C)
Vapor pressure (25 °C)
Henry's law constant
Log Kow
pka
261.12g/mol
815 mg/L
3.1xlO"7torr
l.lX10-9atm*m3/mol
2.11
9.1
USEPA, 1996
USEPA, 1996
USEPA, 1996
USEPA, 1996
Hansch & Leo, 1995
bromacil ionizes at pH 9.1;
USEPA, 1996
Persistence
Hydrolysis
Photolysis in water (t1/2j
days)
Photolysis in soil
(t1/2> days)
Aerobic soil metabolism
(t1/2, days)
Anaerobic soil
metabolism
Aerobic aquatic
metabolism
Anaerobic aquatic
metabolism
pH5: stable
pH 7: stable
pH 9: stable
pH5:356
pH 7: 102
pH 9: 7, 4.3
166
275
No data
No data
No data
MRID 4095 1505
MRIDs 40951507, 40951508
Absorption spectrum shift occurs
in alkaline conditions (at pka of
9.1).
MRID 4095 1509
MRID 4095 15 10
No studies submitted.
No studies submitted.
Submitted study is unacceptable.
Mobility
Column Leaching
Soil Texture % of applied bromacil
found in leachate of the
four columns
Sand total residues in leachate =
Sandy loam 91.2-99.6% of the applied;
„, , bromacil in leachate - 89.0-
Clay loam „. 10/ -., ,. ,
94 1% of the applied
Silt loam
MRID 40951512; Koc of 32 used
in assessment is from SCS/ARS
database (only column leaching
data were available from
submitted studies)
Field Dissipation
Terrestrial field
dissipation (ti/2, days)
155 (silty clay loam soil in DE)
124 (loam soil in CA)
MRID 41677101; dissipation
from soil surface of bare ground
plots
Bioaccumulation
Accumulation in fish,
BCF
2.5-2.8X
MRID 4095 15 13
                                          20

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       2.4.2  Environmental Transport Assessment

Laboratory mobility data,  in  addition to groundwater monitoring information,  have
clearly demonstrated that bromacil is mobile in soil.  However, bromacil's tendency to
leach was not overwhelmingly apparent from the two field  dissipation  studies.  The
timing and amount of rainfall/irrigation in these studies is a possible explanation.

In column leaching studies, bromacil was mobile in columns of sand, sandy loam, clay
                         1-14
loam, and silt loam soils.  [  C]Residues in the leachates of all four soils totaled 91.2-
99.6% of the applied (bromacil comprised 89.0-94.1% of the applied).

Aged (30 days) bromacil residues were also mobile  in  a  column of  silt loam soil.
[14C]Residues in the leachate totaled 87.3% of the applied radioactivity.  Bromacil was
the only  compound  identified  in the leachate,  comprising  82.8% of the applied
radioactivity.

Batch equilibrium data were not submitted for bromacil.  For this assessment, the Koc
value of 32 L/kgoc used in modeling aquatic exposures  was obtained  from the Soil
Conservation  Service Agricultural Research Station (SCS/ARS) database. This value is
similar in magnitude to values reported in the open literature.   Gerstl (1984)  found an
average Koc  value of 23 L/kgoc  from experimental values determined in 8  soils  and 4
sediments.  These values indicate that bromacil is mobile in soil, a conclusion which is
consistent with the results observed in the column leaching studies.

In the field, Bromacil was persistent, but did not demonstrate the degree of mobility that
was predicted based on the laboratory studies  and the available groundwater monitoring
data.  One possible explanation  for the limited mobility  in the two sites could be the
amount and timing of rainfall/irrigation.  However, the average rainfall for the test period
was  about or above  the 30-year  annual average  of 43.36  inches  for Wilmington,
Delaware, so  minimal irrigation was needed. The average rainfall at the second field site
was  below the  30-year annual  average  of 9.84 inches  for Fresno,  California,  so
substantial irrigation was needed.  Irrigation was based on common agricultural practice
for the area. Bromacil (Hyvar® X Herbicide, 80% WP), applied at 12 Ib ai/A, dissipated
with half-lives of 155 days from the upper 10 cm of a bare ground plot of silty clay loam
soil located in Delaware, and 124  days from the upper 10 cm  of a bare  ground plot of
loam soil located in California.  Bromacil was detected at the  Delaware  and California
sites in the upper  10  cm of the plots through 538 and  415 days post treatment,
respectively.

Potential transport mechanisms for bromacil include surface water runoff,  spray  drift,  and
secondary drift of volatilized or soil-bound residues leading to deposition  onto nearby or
more distant  ecosystems. The magnitude  of pesticide transport  via secondary drift
depends on the  pesticide'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.  Based on  the  vapor pressure  and Henry's Law constant of bromacil,
                                       21

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volatilization  from treated areas resulting  in  atmospheric transport and  deposition
represent unlikely transport pathways leading to exposure of the CRLF and its habitats.

       2.4.3   Mechanism of Action

Bromacil is classified in as a uracil herbicide. Bromacil interferes with the photosynthesis
of a plant by blocking electron transport in photosystem II.  Symptoms of plant injury
include chlorosis and death of leaf tissue (Martin 2000).

       2.4.4   Use Characterization

Analysis of labeled  use information  is the critical first step in  evaluating the federal
action.  The  current labels  for  bromacil  and bromacil lithium represent 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. Bromacil and bromacil lithium are currently registered  for use on non-cropland
areas, including (but not  necessarily  limited to) airports, parking lots, industrial areas,
rights-of-way (for railroads, highways, pipeline and utilities), storage areas, lumberyards,
tank farms, under asphalt and concrete pavement and fence rows. These chemicals can
also  be used  in uncultivated portions of agricultural areas, including farmyards, fuel
storage areas, fence  rows and barrier strips.  In addition,  bromacil (but not bromacil
lithium) is registered for use in  citrus orchards and  pineapple fields. Although labels
allow applications of bromacil to pineapple, this crop is not grown in California and is
therefore, not relevant to this assessment (USDA 2007). Maximum application rates and
numbers of applications for uses of bromacil and bromacil lithium are presented in Table
5. Products of bromacil and bromacil lithium include granular and liquid formulations.
                                        22

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       Table 5. Uses and maximum use rates of bromacil and bromacil lithium.
Use
Citrus
Non-
cropland1
Non-
cropland1
Chemical
Bromacil
Bromacil
Bromacil
lithium
Max. single
application
rate in
Ibs a.i./A
(kg a.i./ha)
6.4
(7.2)
15.4
(17.3)
12
(13.4)
Max.#
applications
per year
1
2
1
Timing of
applications
Any time
(best in late fall to
early winter or
winter to early
summer)
Any time (varies
from pre-
emergence to
establishment of
predominant weed
species)
Any time (varies
from pre-
emergence to
establishment of
predominant weed
species)
Formulation
Type
wettable powder,
dispersible
granules
liquid, granular,
water-emulsifiable
concentrate,
pellet,
wettable powder,
dispersible
granules,
emulsion,
aerosol,
water-soluble
liquid
Liquid,
water-soluble
liquid
Application Type
Broadcast,
soil broadcast,
spot soil treatment,
spray
Broadcast,
spot treatment,
spray,
prepaying treatment,
basal spray
treatment, directed
spray
Broadcast,
spot treatment,
spray,
basal spray
treatment, directed
spray, sprinkle
 Non-cropland use includes non-agricultural areas, sewage disposal areas, sewage systems, paved areas, drainage systems.
industrial areas. Examples of non-cropland use include parking lots, around buildings, fence rows, railroad sidings, industrial
yards, pipelines, rights-of-way, lumber yards, highways, under asphalt and concrete pavement, oil refineries, cable coverings,
and substations, vacant lots, waste lagoons, airports, sewage disposal areas, and other similar sites.
 urban areas, and outdoor
plants, tank farms, storage
runway lights, utility poles
       Estimates of national use of bromacil in agriculture are available; however, national-level
       uses  of  bromacil  and  bromacil  lithium  in non-cropland  areas  are  not  available.
       Approximately 410 thousand pounds  of the  active ingredient bromacil were used  on
       citrus in  2002.  Bromacil was used on citrus  in  California, Arizona, Texas and Florida
       (Figure 1; USGS 2007). Use data for bromacil-lithium, which  has no agricultural uses,
       are unavailable.
                                                     23

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                                    BROMACIL - herbicide
                                  2002 estimated annual agricultural use
           Average annual use of
             active ingredient
     (pounds par square mile of agricultural
               land in county)
             EH  no estimated use
             D 0.001  to 0.013
             D 0.014 to 0.116
             D 0.117 to 0.681
             D 0.682 to 3.172
             • >=3.182
 Crops
    Total
Pounds Applied
  Percent
National Use
citrus fruit
  410957
   100.00
Figure 1. Historical (2002) extent of bromacil use in agricultural areas.

Pesticide use  data  available from  the California Department of Pesticide Regulation
(CDPR 2007a), includes  county-level data for various bromacil uses,  including both
agricultural  and  non-agricultural  uses.  From 2002-2005, an  annual  average  of 54
thousand pounds of bromacil were used in California.  The percentage of total bromacil
use in California was highest on oranges (39.9%  of total pounds applied), rights-of-way
(36.3%), lemons (8.1%), landscape maintenance  (6.7%) and grapefruit (3.4%).  Use on
citrus  and rights-of-way  represent 91.5%  of total pounds of bromacil applied  in
California  during  2002-2005.  Applications of bromacil  to  citrus and rights-of-way
occurred in counties  throughout the state, including those also containing CRLF core
areas and critical habitat.

Pesticide use data for bromacil lithium indicates that from 2002-2005, an annual average
of 9.9 thousand pounds of bromacil lithium were used in California.  Rights-of-way
represent 98.3% of the total applied pounds, while the remaining 1.7% of bromacil
lithium applied was used for "landscape maintenance." Applications of bromacil lithium
                                        24

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occurred in counties throughout the state, including those also containing CRLF core
areas and critical habitat (CDPR 2007a).

Analysis of CDPR data for bromacil use in California from 2001-2005 (CDPR 2007a)
indicates that, although the majority of single applications for citrus were at rates that fell
below the maximum  single application rate of 6.4 Ibs a.i./A, some applications were
possibly above this application rate. Estimated application rates ranged 0.01-20 Ibs a.i./A,
with a 90th percentile of 1.7 Ibs a.i./A (n = 916). Fewer data are available for specific
applications of bromacil to non-cropland areas. Of the available data, application rates
ranged 0.4-14.5 Ibs a.i./A, with a 9(r percentile of 5.1 Ibs a.i./A (n = 20).

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 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.

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).

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
                                        25

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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).  Recovery units, core areas, and other known occurrences of the CRLF from
the CNDDB are described in further detail in this section, 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.

Recovery Units

Eight recovery units have been established by USFWS  for the CRLF.  These areas are
considered essential to the recovery of the species, and the status of the CRLF "may be
considered within  the smaller scale of the recovery  units, as opposed to the statewide
range" (USFWS 2002). Recovery  units reflect areas with similar conservation needs and
population  statuses, and therefore,  similar recovery goals. The eight units described for
the CRLF  are delineated  by watershed boundaries defined by  US Geological  Survey
hydrologic units and are limited to the elevational maximum for the species of 1,500 m
above sea level.  The eight recovery units for the CRLF  are listed in Table 6 and shown
in Figure 2.

Core Areas

USFWS  has designated 35 core  areas across  the eight  recovery units to focus their
recovery efforts  for the CRLF  (see Figure 2).  Table  6 summarizes the geographical
relationship among recovery units, core areas, and designated critical  habitat.  The core
areas, which are distributed throughout portions of the historic and current range of the
species, represent  areas that allow for long-term viability of existing populations  and
reestablishment of populations within historic range.  These areas were selected because
they: 1) contain existing viable populations; or 2) they contribute to the connectivity of
other habitat areas (USFWS 2002). Core area protection and enhancement are vital for
                                        26

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maintenance  and expansion of the CRLF's distribution and population throughout its
range.

For purposes of this  assessment, designated critical habitat, currently  occupied (post-
1985) core areas, and additional known occurrences of the CRLF from the CNDDB are
considered.  Each type of locational information is evaluated within the broader  context
of recovery units. For example, if no labeled uses of bromacil or bromacil lithium occur
(or if labeled uses occur at predicted exposures less than the Agency's LOCs) within an
entire recovery unit, a "no effect" determination would be made for all designated critical
habitat, currently occupied core areas, and other known CNDDB occurrences within that
recovery unit. Historically occupied sections of the core areas are not evaluated as part of
this assessment because the USFWS Recovery Plan (USFWS 2002) indicates that CRLFs
are extirpated from these areas.  A summary of currently and historically occupied core
areas is provided in Table 6 (currently occupied core areas are bolded).  While core areas
are considered essential for recovery of the CRLF, core areas are not federally-designated
critical habitat, although designated critical habitat is generally contained within these
core recovery areas.   It should be  noted, however, that  several critical habitat units are
located outside of the  core  areas, but within the recovery units.  The  focus  of this
assessment is currently occupied core  areas, designated critical habitat, and other known
CNDDB CRLF occurrences  within  the  recovery units. Federally-designated  critical
habitat for the CRLF is further explained in Section 2.6.
                                        27

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Table 6. California Red-legged Frog Recovery Units with Overlapping Core Areas and Designated
Critical Habitat.
Recovery Unit 1
(Figure 2)
Sierra Nevada
Foothills and Central
Valley (1)
(eastern boundary is
the 1,500m elevation
line)
North Coast Range
Foothills and
Western Sacramento
River Valley (2)
North Coast and
North San Francisco
Bay (3)
South and East San
Francisco Bay (4)
Central Coast (5)
Core Areas 2'7 (Figure 2)
Cottonwood Creek (partial)
(8)
Feather River (1)
Yuba River-S. Fork Feather
River (2)
—
Traverse Creek/Middle Fork
American River/Rubicon (3)
Consumnes River (4)
S. Fork Calaveras River (5)
Tuolumne River (6)
Piney Creek (7)
East San Francisco Bay
(partial)(16)
Cottonwood Creek (8)
Putah Creek-Cache Creek (9)
Jameson Canyon - Lower
Napa Valley (partial) (15)
Belvedere Lagoon (partial)
(14)
Pt. Reyes Peninsula (partial)
(13)
Putah Creek-Cache Creek
(partial) (9)
Lake Berryessa Tributaries
(10)
Upper Sonoma Creek (11)
Petaluma Creek-Sonoma
Creek (12)
Pt. Reyes Peninsula (13)
Belvedere Lagoon (14)
Jameson Canyon-Lower
Napa River (15)
—
East San Francisco Bay
(partial) (16)
—
South San Francisco Bay
(partial) (18)
South San Francisco Bay
(partial) (18)
Watsonville Slough- Elkhorn
Slough (partial) (19)
Carmel River-Santa Lucia
(20)
Estero Bay (22)
~
Critical Habitat
Units 3
~
BUT-1A-B
YUB-1
NEV-16
~
ELD-1
—
—
—
~
~
~
~
~
~
~
NAP-1
—
~
MRN-1, MRN-2
—
SOL-1
CCS-1A6
ALA-1A, ALA-
IB, STC-1B
STC-1A6
SNM-1A
SNM-1A, SNM-
2C, SCZ-1
SCZ-2 5
MNT-2
~
SLO-86
Currently
Occupied
(post-
1985) 4
•/
S
S

•/
•/



•/
•/

S
S
•/

•/
•/
•/
•/
•/
•/

•/

•/
•/
•/
•/
S

Historically
Occupied 4






•/
•/
•/


•/



•/















                                            28

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Diablo Range and
Salinas Valley (6)
Northern Transverse
Ranges and
Tehachapi Mountains
(7)
Southern Transverse
and Peninsular
Ranges (8)
Arroyo Grande Creek (23)
Santa Maria River-Santa
Ynez River (24)
East San Francisco Bay
(partial) (16)
~
Santa Clara Valley (17)
Watsonville Slough- Elkhorn
Slough (partial)(19)
Carmel River-Santa Lucia
(partial)(20)
Gablan Range (21)
Estrella River (28)
~
Santa Maria River-Santa
Ynez River (24)
Sisquoc River (25)
Ventura River-Santa Clara
River (26)
~
Santa Monica Bay-Ventura
Coastal Streams (27)
San Gabriel Mountain (29)
Forks of the Mojave (30)
Santa Ana Mountain (31)
Santa Rosa Plateau (32)
San Luis Rey (33)
Sweetwater (34)
Laguna Mountain (35)
—
~
MER-1A-B,
STC-1B
SNB-16, SNB-26
~
MNT-1
~
SNB-3
SLO-1A-B
SLO-86
STB-4, STB-5,
STB-7
STB-1, STB-3
VEN-1, VEN-2,
VEN-3
LOS-16
~
~
~
~
~
~
~
~
•/
S
s

s
s
s
s
s

•/
•/
•/

s



s


















s
s
s

s
s
s
1 Recovery units designated by the USFWS (USFWS 2000, pg 49).
2 Core areas designated by the USFWS (USFWS 2000, pg 51).
3 Critical habitat units designated by the USFWS on April 13, 2006 (USFWS 2006, 71 FR 19244-19346).
4 Currently occupied (post-1985) and historically occupied core areas as designated by the USFWS
(USFWS 2002, pg 54).
5 Critical habitat unit where  identified threats specifically included pesticides or agricultural runoff
(USFWS 2002).
6 Critical habitat units that are outside of core areas, but within recovery units.
7 Currently occupied core areas that are included in this effects determination are bolded.
                                               29

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                                                    Recovery Units
                                                            Sierra Nevada Foothills and Central Valley
                                                            North Coast Range Foothills and Western
                                                            Sacramento River Valley
                                                            North Coast and North San Francisco Bay
                                                            South and East  San Francisco Bay
                                                            Central Coast
                                                            Diablo Range and Salinas Valley
                                                            Northern Transverse Ranges and Tehachapi
                                                            Mountains
                                                            Southern Transverse and Peninsular Ranges
    Legend
    I    I Recovery Unit Boundaries
       | Currently Occupied Core Areas
    ^^| Critical Habitat
       • CNDDB  Occurence Sections
         County Boundaries
                                     45
Core Areas
    1.   Feather River
    2.   Yuba River- S. Fork Feather River
    3.   Traverse Creek/ Middle Fork/ American R. Rubicon
    4.   Cosumnes River
    5.   South Fork Calaveras River*
    6.   Tuolumne River*
    7.   Piney Creek*
    8.   Cottonwood Creek
    9.   Putah Creek - Cache Creek*
    10.  Lake Berryessa Tributaries
    11.  Upper Sonoma Creek
    12.  Petaluma Creek - Sonoma Creek
    13.  Pt. 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
19.  Watsonville Slough-Elkhorn Slough
20.  Carmel River - Santa Lucia
21.  Gablan 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*
34.  Sweetwater*
35.  Laguna Mountain*
* Core areas that were historically occupied by the California red-legged frog are not included in the map


Figure 2. Recovery Unit, Core Area, Critical Habitat, and Occurrence Designations for CRLF.
                                                 30

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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.
       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 3 depicts CRLF annual reproductive timing.
    Month
Breeding/Egg
Masses
Adults and
Juveniles
Figure 3. CRLF Reproductive Events by Month.

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       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
                                       32

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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
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 Table 2.

'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 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
                                        33

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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.

Please note that  a more complete  description of these habitat types is  provided in
Attachment 1.

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
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 1 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 bromacil and  bromacil lithium 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) 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.
    (3) 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.
                                        34

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    (4) Elimination of upland foraging and/or aestivating habitat or dispersal habitat.
    (5) Introduction,  spread,  or augmentation  of non-native  aquatic species in stream
        segments or ponds used by the CRLF.
    (6) 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 bromacil  and  bromacil lithium is expected to
directly impact living organisms  within the action area, critical habitat analysis  for
bromacil and bromacil lithium 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.

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 bromacil  and  bromacil  lithium is  likely to  encompass
considerable portions of the United States based on the uses on citrus and the large array
of uses  on  non-cropland  areas.    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.
Deriving the geographical extent  of this portion of the  action area is  the  product  of
consideration of the types of effects that bromacil and bromacil lithium may be expected
to have on the environment, the exposure levels to bromacil that are associated with those
effects, and the best available information concerning the use of bromacil and its fate and
transport within the 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 bromacil and bromacil lithium.  An  analysis of labeled uses and review  of
available product labels was completed.  This analysis indicates  that for bromacil and
bromacil lithium, the following uses are considered as part of the federal action evaluated
in this assessment:

  . Citrus (oranges, lemons, tangerines, tangelos, grapefruit, etc.)
  . Non-cropland  areas  (airports,  parking  lots, industrial   areas,  rights-of-way (for
   railroads, highways, pipeline and utilities), storage  areas, lumberyards, tank farms,
   under asphalt and concrete pavement and fence rows, etc.)

The  analysis indicates  that pineapple,  which  is a registered use of bromacil, is not
considered in this assessment, since the crop is not grown in California and therefore, the
use is not expected to result in exposure to the CRLF.
                                        35

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After the determination of which uses will be assessed,  an evaluation of the potential
"footprint" of the use pattern is determined.  This "footprint" represents the initial area of
concern  and is typically based on available  land  cover data.  Local  land cover data
available for the state of California were analyzed to refine the understanding of potential
bromacil and bromacil lithium uses.  The initial area of concern  is defined as all land
cover types that represent the labeled uses described above. The initial area of concern is
represented by  1)  orchard  and  vineyard  landcovers which  are  assumed  to be
representative of citrus and  2)  rights-of-way which are assumed to be representative of
non-cropland areas. Maps representing the land cover types that make up the initial areas
of concern for citrus and  non-cropland areas are presented in  Figures  4  and 5,
respectively. These maps represent the areas directly affected by the federal action.

It should be noted that the initial action area map for non-cropland areas is defined only
by rights-of-way, and does not include  several other potential  non-cropland  uses of
bromacil and bromacil lithium  (e.g. parking lots, fence rows, tank farms, storage yards,
etc.). The initial action area for  non-cropland areas is actually larger than what is depicted
in Figure 5; however, spatial data are unavailable at this time to define the extent of these
additional non-cropland areas where bromacil and bromacil lithium can be applied. Since
rights-of-way areas make up the majority of past use of bromacil  (81.0%) and bromacil
lithium (98.3%) on non-cropland areas, rights-of-way are relevant for defining the spatial
extent of non-cropland areas.

Once the initial area of concern is defined, the next step is to compare the extent of that
area with the results of the screening level risk assessment.  In this assessment, transport
of bromacil through runoff and  spray drift is considered in deriving quantitative estimates
of bromacil exposure to CRLF,  its prey and its  habitats.

Since this screening level risk  assessment defines taxa that are predicted to be exposed
through runoff and  drift to bromacil at concentrations  above the Agency's Levels of
Concern (LOG), there is need to expand the action area to include  areas that are affected
indirectly by  this federal  action.   Two methods  are  employed to define the areas
indirectly affected by the federal action, and thus  the  total action  area.  These are the
down stream dilution assessment for determining the extent of the affected  lotic aquatic
habitats (flowing water) and the spray drift  assessment for determining  the extent of the
affected terrestrial habitats.  In  order to define the final action areas relevant to uses of
bromacil and  bromacil lithium  on  citrus and  non-cropland areas,  it is necessary to
combine areas directly affected, as well as  aquatic and terrestrial habitats indirectly
affected by the federal action. It is assumed that lentic (standing water) aquatic habitats
(e.g. ponds, pools, marshes) overlapping with  the  terrestrial areas are also indirectly
affected by the federal action The analysis of areas indirectly affected by the federal
action, as well  as  the  determination of the final action area  for bromacil and
bromacil lithium  is described in  the risk discussion  (Section  5.2.5). Additional
analysis related to the intersection of the bromacil and bromacil lithium action area and
CRLF habitat used in determining the  final action area is described  in Appendix H.
                                        36

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                                                                                       N
              Legend

              |     | County Boundary

             90
                   45
                                       90 Miles
    Compiled from California County boundaries (ESRI, 2002),
    USDA National Agriculture Statistical Service (MASS, 2002)
    Gap Analysis Program Orchard/Vineyard Landcover (GAP)
    National Land Cover Database (NLCD) (MRLC.2001)
Map created by U.S. Environmental Protection Agency,
Office of Pesticides Programs, Environmental Fate and
Effects Division. April 11, 2007.
Projection: Albers Equal Area Conic USGS,
North American Datum of 1983 (NAD 1983)
Figure 4. Initial action area for crops described by orchard and vineyard landcover which
corresponds to potential bromacil use sites on citrus. This map represents the area potentially
directly affected by the federal action.
                                                  37

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             Legend

             |	| County Boundary

                 • CA_Right_of_Way
                                                                                   \
                                                                                JL
            90
                  45
                                     90 Miles
   Compiled from California County boundaries (ESRI, 2002),
   USDANationalAgriculture Statistical Service (MASS,2002)
   Gap Analysis Program Orchard/Vineyard Landcover (GAP)
   National Land Cover Database (NLCD) (MRLC.2001)
Map created by U.S. Environmental Protection Agency,
Office of Pesticides Programs, Environmental Fate and
Effects Division. April 11, 2007.
Projection: Albers Equal Area Conic US6S,
North American Datum of 1983 (NAD 1983)
Figure 5. Initial action area for crops described by right-of-way landcover which corresponds to
potential bromacil and bromacil lithium use sites on (some) non-cropland areas. This map represents
the area potentially directly affected by the federal action.
                                                   38

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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" (USEPA 1992). 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 bromacil and bromacil lithium (e.g., runoff, spray drift, etc.), and the routes
by which ecological receptors  are exposed to  bromacil and bromacil lithium -related
contamination (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  and/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.

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 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 bromacil  and bromacil lithium is
provided in Table 7.
                                        39

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Table 7. Summary of Assessment Endpoints and Measures of Ecological Effects for Direct and
Indirect Effects of bromacil and bromacil lithium on the California Red-legged Frog.
Assessment Endpoint
Measures of Ecological Effects
Aquatic Phase (eggs, larvae, tadpoles, juveniles, and adults)1
1. Survival, growth, and reproduction of
CRLF individuals via direct effects on
aquatic phases
2. Survival, growth, and reproduction of
CRLF individuals via effects to food
supply (i.e., freshwater invertebrates, non-
vascular plants)
3. Survival, growth, and reproduction of
CRLF individuals via ndirect effects on
habitat, cover, and/or primary productivity
(i.e., aquatic plant community)
4. 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.
la. most sensitive fish2 96-h LCso = 36 mg/L (Rainbow
trout)
Ib. most sensitive fish2 chronic NOAEC = 3.0 mg/L
(Rainbow trout)
2a. most sensitive fish 96-h LCso = 36 mg/L (Rainbow trout)
2b. most sensitive fish chronic NOAEC = 3.0 mg/L
(Rainbow trout)
2c. Most sensitive aquatic invertebrate 48-hEC50= 121 mg/L
(waterflea)
2d. Most sensitive aquatic invertebrate chronic NOAEC =
8.2 mg/L (waterflea)
2e. Most sensitive aquatic unicellular plant EC50 = 0.0068
mg/L (green algae)
3a. Most sensitive aquatic unicellular plant EC50= 0.0068
mg/L (green algae)
3b. Vascular aquatic plant EC50 = 0.045 mg/L (duckweed)
4a. Most sensitive EC25 for monocots = 0.030 Ibs a.i./A
(wheat)
4b. Most sensitive EC25 for dicots = 0.0047 Ibs a.i./A (rape)
Terrestrial Phase (Juveniles and adults)
5. Survival, growth, and reproduction of
CRLF individuals via direct effects on
terrestrial phase adults and juveniles
6. Survival, growth, and reproduction of
CRLF individuals via effects on prey
(i.e., terrestrial invertebrates, small
terrestrial vertebrates, including mammals
and terrestrial phase amphibians)
7. Survival, growth, and reproduction of
CRLF individuals via indirect effects on
habitat (i.e., riparian vegetation)
5a. Most sensitive bird3 acute LD50 >2250 mg/kg (Northern
bobwhite quail)
5b. Most sensitive bird3 sub-acute LC50>10,000 mg/kg-diet
(Northern bobwhite quail)
5c. Most sensitive bird3 chronic NOAEC = 1550 mg/kg-diet
(Northern bobwhite quail)
6a. Most sensitive terrestrial invertebrate LD50>1209 ug
a.i./g (honey bee)
6b. Most sensitive terrestrial mammal acute LD50 = 812
mg/kg (laboratory rat)
6c. Most sensitive terrestrial mammal chronic NOAEL = 250
mg/kg-diet/day (laboratory rat)
6d. Most sensitive bird3 acute LD50 >2250 mg/kg (Northern
bobwhite quail)
6e. Most sensitive bird3 sub-acute LC50>10,000 mg/kg-diet
(Northern bobwhite quail)
6f. Most sensitive bird3 chronic NOAEC = 1550 mg/kg-diet
(Northern bobwhite quail)
7a. Most sensitive EC25 for monocots = 0.030 Ibs a.i./A
(wheat)
7b. Most sensitive EC25 for dicots = 0.0047 Ibs a.i./A (rape)
'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.
 Frogs are used as surrogates for aquatic-phase CRLF and aquatic-phase frog species which are prey to CRLF.
3 Birds are used as surrogates for terrestrial phase CRLF and terrestrial-phase frog species which are prey to CRLF.
                                                    40

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       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 bromacil  and bromacil lithium  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.  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 bromacil and bromacil lithium effects data are available.

Assessment endpoints and measures of ecological effect selected to characterize potential
modification to designated  critical habitat associated with exposure to bromacil  and
bromacil lithium  are provided in  Table 8.  Modification to the  critical habitat of the
CRLF includes the following, as specified by USFWS (2006) and previously discussed in
Section 2.6:

   1.     Alteration of water chemistry/quality including  temperature, turbidity,  and
          oxygen content necessary for normal growth and  viability of juvenile  and
          adult CRLFs.
   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.
   4.     Significant alteration of channel/pond morphology or geometry.
   5.     Elimination of upland foraging and/or aestivating habitat, as well as 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.

Measures of such possible effects by labeled  use of bromacil and bromacil lithium on
critical habitat of the CRLF are described in Table 8. 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

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   Table 8. Summary of Assessment Endpoints and Measures of Ecological Effect for Primary
   Constituent Elements of Designated Critical Habitat.	
Assessment Endpoint
Measures of Ecological Effect
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.
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)
la. Most sensitive aquatic unicellular plant EC50= 0.0068
mg/L (green algae)
Ib. Vascular aquatic plant EC50 = 0.045 mg/L (duckweed)
Ic. Most sensitive EC2s for monocots = 0.030 Ibs a.i./A
(wheat)
Id. Most sensitive EC25 for dicots = 0.0047 Ibs a.i./A (rape)
2a. Most sensitive aquatic unicellular plant EC50= 0.0068
mg/L (green algae)
2b. Vascular aquatic plant EC50 = 0.045 mg/L (duckweed)
2c. Most sensitive EC25 for monocots = 0.030 Ibs a.i./A
(wheat)
2d. Most sensitive EC25 for dicots = 0.0047 Ibs a.i./A (rape)
3a. most sensitive fish2 96-h LC50 = 36 mg/L (Rainbow trout)
3b. most sensitive fish2 chronic NOAEC = 3.0 mg/L
(Rainbow trout)
3c. Most sensitive aquatic invertebrate 48-hEC50= 121 mg/L
(waterflea)
3d. Most sensitive aquatic invertebrate chronic NOAEC = 8.2
mg/L (waterflea)
3e. Most sensitive aquatic unicellular plant EC50 = 0.0068
mg/L (green algae)
4a. Most sensitive aquatic unicellular plant EC50= 0.0068
mg/L (green 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.
5a. Most sensitive EC2s for monocots = 0.030 Ibs a.i./A
(wheat)
5b. Most sensitive EC25 for dicots = 0.0047 Ibs a.i./A (rape)
5c. Most sensitive terrestrial invertebrate LD50>1209 ug a.i./g
(honey bee)
6d. Most sensitive terrestrial mammal acute LD50 = 812
mg/kg (laboratory rat)
5e. Most sensitive terrestrial mammal chronic NOAEL = 250
mg/kg-diet/day (laboratory rat)
5f. Most sensitive bird3 acute LD50 >2250 mg/kg (Northern
bobwhite quail)
5g. Most sensitive bird3 sub-acute LC50>10,000 mg/kg-diet
(Northern bobwhite quail)
5h. Most sensitive bird3 chronic NOAEC = 1550 mg/kg-diet
(Northern bobwhite quail)
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.
2 Frogs are used as surrogates for aquatic-phase CRLF and aquatic-phase frog species which are prey to CRLF.
 Birds are used as surrogates for terrestrial phase CRLF and terrestrial-phase frog species which are prey to CRLF.
                                                   42

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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 bromacil and bromacil lithium
to the environment.  The following risk hypotheses are presumed for this endangered
species assessment:

•      Labeled uses of bromacil and bromacil lithium within the action area may directly
       affect the  CRLF by  causing  mortality  or by adversely affecting growth or
       fecundity;
•      Labeled uses  of bromacil  and  bromacil lithium within the  action area may
       indirectly  affect  the  CRLF by  reducing  or changing the composition of food
       supply;
•      Labeled uses  of bromacil  and  bromacil lithium within the  action area may
       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;
•      Labeled uses  of bromacil  and  bromacil lithium within the  action area may
       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;
•      Labeled uses of bromacil and bromacil lithium within the action area may modify
       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);
•      Labeled uses of bromacil and bromacil lithium within the action area may modify
       the designated critical habitat of the CRLF by reducing the food supply required
       for normal growth and viability of juvenile and adult CRLFs;
•      Labeled uses of bromacil and bromacil lithium within the action area may modify
       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.
•      Labeled uses of bromacil and bromacil lithium within the action area may modify
       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.
•      Labeled uses of bromacil and bromacil lithium within the action area may modify
       the designated critical habitat of the  CRLF by altering chemical characteristics
       necessary  for normal growth and viability of juvenile and adult CRLFs.
                                       43

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       2.9.2   Diagram

The conceptual model is a graphic representation of the structure of the risk assessment.
It specifies the stressor (bromacil  and bromacil lithium), release mechanisms, biological
receptor types, and effects  endpoints of potential concern.  The conceptual models for
aquatic and terrestrial  phases of the CRLF are shown in Figures 6 and 7, and the
conceptual models for the aquatic and terrestrial PCE components of critical habitat are
shown in Figures 8 and 9.  Exposure routes shown in dashed lines are not quantitatively
considered because the resulting  exposures are expected to be so low as not to cause
adverse effects to the CRLF.

The environmental fate properties of bromacil, along with monitoring data identifying its
presence  in surface water and groundwater in California, indicate that runoff and spray
drift represent potential transport  mechanisms of bromacil to the aquatic and  terrestrial
habitats of the CRLF. In this assessment, transport of bromacil through runoff/ leaching
and spray drift is considered in deriving quantitative estimates of bromacil exposure to
CRLF, its prey and its habitats. Based on the vapor pressure and Henry's Law constant of
bromacil,  volatilization from treated  areas  resulting  in  atmospheric  transport  and
deposition represent unlikely transport pathways leading to exposure of the CRLF and its
habitats.  Therefore, exposure of the CRLF and its habitat to bromacil through runoff and
spray drift to surface waters, and leaching to groundwater with  subsequent interaction of
groundwater to surface waters are the exposure pathways considered in this assessment.
The exposure route from groundwater interacting with runoff is implicitly accounted for
in exposure modeling which relies on the curve number method  which is based on stream
response  (whether overland or subsurface) to a rain event. Both overland and subsurface
flows are  driven by rain events. Also, acute exposure concentrations from ground water
are likely to be lower than those estimated for surface water.
                                       44

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Stressor
Source
Exposure
Media
                                            Pesticide applied to use site
Spray drift 1

|

Surface wate
Sediment
Runoff 1 1 So!l 1 	 H Groundwater |

r/

4 ..Wet/

dry deposition
                                                                           	T.	
                                                                            Long range
                                                                            atmospheric
                                                                             transport
                                Uptake/gills
                                or integument
                                           Uptake/cell,
                                          roots, leaves
             Uptake/gill*
             or integument
Receptors
 Attribute
 Change
                 Aquatic Animals
                 Invertebrates
                 Vertebrates
                                   Ingestion
                Red-legged Frog
                Eggs   Juveniles
                Larvae  Adult
                Tadpoles
Individual organisms
Reduced survival
Reduced growth
Reduced reproduction
Aquatic Plants
Non-vascular
Vascular
                                               t
                                          Ingestion
                                         Food chain
                                         Reduction in algae
                                         Reduction in prey
                 Habitat integrity
                 Reduction in primary productivity
                 Reduced cover
                 Community change
Figure 6. Conceptual Model for Pesticide Effects on Aquatic Phase of the Red-Legged Frog.
                                                  45

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Stressor
Pesticide applied to use site

4
SonrrP Direct — ~±_
application / J
Exposure I 1 T*1

Terrestrial jer
insects gra
Ingestion
1



Ingestion
1 ,.
Receptors Red-legged Frog .
Juvenile
Adult 4.

^ r
Attribute Individual organisms
Change Reduced survival
Reduced growth
Reduced reproduction
i '

__f "^—Dermal uptake/Inge
^-
sses/forbs, fruit, seeds
(trees, shrubs)




U Inaestion ^
r
tt


i r ^ '
Food chain
Reduction in prey

| ^


;stion ^_ Soil
— - Root uptake -^J


Ingestion 1


|

i
Habitat inte(
Reduction in
Community c
K

r
ry deposition -4-
r
jrity
primary productivity
er
hange
Figure 7. Conceptual Model for Pesticide Effects on Terrestrial Phase of Red-Legged Frog.
                                            46

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 Stressor
Source

Exposure
Media
Receptors
Attribute
Change
Habitat
PCEs


^
1 Spray drift 1

Surfac
Sed
1
Pesticide

+
1 Runoff 1


ment [^ 	
41
ills
or integument
applied to use site

z_
Soil | 	



Uptake/cell,




1
• Wet/dry deposition



	 .T. 	
Long range
atmospheric
transport


   Uptake/gills
   or integument
                                                         roots, leaves
              Red-legged Frog
              Eggs   Juveniles
              Larvae Adult
              Tadpoles
                                 Aquatic Animals
                                 nvertebrates
                                 Vertebrates
               Aquatic Plants
               Non-vascular
               Vascular
                   ^	Ingestion
 Individual organisms
 Reduced survival
 Reduced growth
 Reduced reproduction
Other chemical
characteristics
Adversely modified
chemical characteristics
                       T
                   Ingestion
Individual organisms
Reduced survival
Reduced growth
Reduced reproduction
                 Riparian and Upland
                   plants terrestrial
                exposure pathways and
                  PCEs see Figure 7
 Population
 Yield
 Reduced yield
Food sources
Reduction in algae
Reduction in prey
                                                                      I
                                                                             I
Community
Reduced seedling
emergence or vegetative
vigor (Distribution)
Habitat quality and channel/pond
morphology or geometry
Adverse water quality changes
Increased sedimentation
Reduced shelter
Figure 8. Conceptual Model for Pesticide Effects on Aquatic Components of Red-Legged Frog
Critical Habitat.
                                                  47

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  Stressor
 Source
  Exposure
  Media and
  Receptors

Pesticide applied

1
i
to use site


                                           \  Spray drift
                                                          Runoff
                                             .J.	
                                           Long range
                                          atmospheric
                                           transport
                                      Dermal uptake/lngestion
                               Terrestrial plants
                              grasses/forbs, fruit,
                             seeds (trees, shrubs)
                                               Root uptake  -4!
                                              	Wet/dry deposition
                                                         ^•Ingestion
                                                     Ingestion
           Red-legged Frog
           Juvenile
           Adult
Attribute
Change
Habitat
PCEs
                                          Ingestion
 Individual organisms
 Reduced survival
 Reduced growth
 Reduced reproduction
Other chemical
characteristics
Adversely modified chemical
characteristics
                                                Hngest

                                                Ll
                                                           Mammals
Population
Reduced survival
Reduced growth
Reduced reproduction
                                  Food resources
                                  Reduction in food
                                  sources
Community
Reduced seedling emergence or
vegetative vigor (Distribution)
                    Elimination and/or disturbance of
                    upland or dispersal habitat
                    Reduction in primary productivity
                    Reduced shelter
                    Restrict movement
Figure 9. Conceptual Model for Pesticide Effects on Terrestrial Components of Red-Legged Frog
Critical Habitat.
2.10  Analysis Plan

In order to address the risk hypothesis, the potential for adverse effects on the CRLF, its
prey  and its habitat is estimated.  In the following sections, the use, environmental fate,
and ecological effects of bromacil and its lithium salt are characterized and integrated to
assess the  risks  to the CRLF.   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 (USEPA 2004), the
likelihood of effects to individual organisms from particular uses of a pesticide such as
bromacil is estimated using the probit dose-response slope and either the level of concern
(discussed below) or actual calculated risk quotient value.
                                            48

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       2.10.1. Measures to Evaluate the Risk Hypothesis and Conceptual Model

             2.10.1.1. Measures of Exposure

Measures of exposure are based on aquatic and terrestrial models that predict estimated
environmental concentrations (EECs) of bromacil using maximum labeled application
rates and methods.  The models used to predict aquatic EECs are the Pesticide Root Zone
Model coupled with the Exposure Analysis Model System (PRZM/EXAMS).  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 was TerrPlant. These models are parameterized
using relevant reviewed registrant-submitted environmental fate data.

PRZM (v3.12beta, May 24, 2001) and EXAMS (V2.98.04, Aug. 18, 2002) are screening
simulation models coupled with the input shell pe4v01.pl (Aug.8, 2003) to generate daily
exposures and l-in-10 year EECs of bromacil that may occur  in surface water  bodies
adjacent to application sites receiving bromacil 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 that is 2 meters deep (20,000 m3 volume) with no outlet. PRZM/EXAMS is used to
estimate screening-level exposure of aquatic organisms to bromacil.  The measures of
exposure for  aquatic  species  are 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 1-in-10-year 60-
day mean is used for assessing chronic exposure  to the CRLF and fish and frogs serving
as prey items. The 1-in-10-year 21-day mean is  used for assessing aquatic invertebrate
chronic exposure, which are also potential prey items.

Exposure estimates for terrestrial phase CRLF and terrestrial invertebrates and mammals
(serving as potential prey) assumed  to be in the target area or in an area 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).   The Fletcher et al.  (1994) modifications to
the Kenega nomograph are based on measured field residues from 249 published research
papers, including information on 118 species of  plants, 121 pesticides, and 17 chemical
classes. These modifications represent the 95th percentile of the expanded data set.  For
modeling purposes, direct exposures of the CRLF to bromacil 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
                                       49

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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 bromacil 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, application rate and
minimum incorporation depth.

Two spray drift  models, AGDisp and AgDRIFT are used to assess exposures of terrestrial
phase CRLF and its prey to bromacil  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 using the Gaussian farfield extension. AgDrift
(version 2.01; dated 5/24/2001) is used to simulate spray blast applications to  orchard
crops.

             2. W.I.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 (ECOTOX, 2006).

The assessment of risk for direct effects to the CRLF makes the assumption that  toxicity
of bromacil to birds is similar to 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,
                                       50

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small mammals, and terrestrial phase amphibians represent potential prey of the CRLF in
the terrestrial habitat. Aquatic plants and semi-aquatic 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).

              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  the  use of bromacil on citrus and non-
cropland areas, 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 bromacil  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 Table 9).  These criteria are used to indicate when bromacil's and bromacil
lithium's uses, as directed on the  label,  have the potential  to  cause adverse direct or
indirect effects to the CRLF.
                                        51

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      Table 9. Agency risk quotient (RQ) metrics and levels of concern (LOG) per risk class.
Risk Class
Description
RQ
LOC
Aquatic Habitats
Acute Listed
Species
Chronic Listed
and Non-Listed
Species
Non-Listed
CRLF may be potentially affected by use by direct or indirect
effects.
Potential for chronic risk to CRLF through direct or indirect
effects. Indirect effects represented by effects to invertebrates, fish
or amphibians, which represent potential prey.
Potential for effects in non-listed plants.
Peak EEC/ECso1
60-day EEC/NOEC
(CRLF)
21 -day EEC/NOEC
(invertebrates)
Peak EEC/ EC50
0.05
1
1
Terrestrial Habitats
Acute Listed
Species
Acute Listed
Species
Acute Non-
Listed Species
Chronic Listed
Species
Non-Listed
CRLF may be potentially affected by use by direct or indirect
effects.
Potential effects to terrestrial invertebrates. CRLF may be
potentially affected by use by direct or indirect effects.
CRLF may be potentially affected by use by indirect effects
through effects to animal prey (i.e. mice and terrestrial-phase
amphibians).
Potential for chronic risk to CRLF through direct or indirect
effects. Indirect effects represented by effects to small mammals,
which represent potential prey.
Potential for effects in non-listed plants.
Dietary EEC 2/LC50
Or
Dose EEC 2/LD50
EEC 2/LD50
Dietary EEC 2/LC50
Or
Dose EEC 2/LD50
EEC 2/NOAEC
Peak EEC/ EC25
0.1
0.05
0.5
1
1
2 Based on upper-bound Kenaga values.


             2.10.2. Data Gaps

      Environmental Fate

      Degradate information is not available for aqueous photodegradation at pH 9 (at which an
      absortion spectrum shift occurs relative to more acidic pHs), where bromacil is relatively
      rapidly degraded.

      Additionally, the half-life for anaerobic aquatic metabolism  has  not  been accurately
      determined. Because OPP does not find the reported half-life to be valid,  an assumption
      of stability had to be used in the aquatic exposure modeling for this assessment in lieu of
      data.

      Mobility data  are only available for column leaching studies; batch equilibrium studies
      have not been submitted, so Kd and  Koc values are lacking.  For aquatic exposure
      modeling, the Koc value was obtained from the SCS/ARS database, and indicates a high
      level of mobility that is in agreement with the mobility observed in the column leaching
      studies (in which [14C]residues in the  leachates of all four soil columns totaled 91.2-
      99.6% of the applied).

      While two terrestrial field dissipation studies  have been submitted, both were on bare
      ground plots.  A citrus field dissipation study on soils in California is not available.
                                              52

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Effects characterization

No data are available for defining the toxicity of bromacil to amphibians. As a result,
direct effects  to the  CRLF  in  aquatic habitats are  based on toxicity  information for
freshwater fish,  which serves as a surrogate for aquatic amphibians.  Also, direct effects
to the CRLF in terrestrial habitats are based on toxicity information for birds, which serve
as a surrogate  for terrestrial-phase amphibians.

Data are unavailable  to define the sub-acute (dietary) exposure of technical bromacil to
birds. In place of this  gap, data are used from a  study involving dietary exposures of birds
to a formulated product containing bromacil.
                                         53

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3. Exposure Assessment

3.1. Aquatic Exposure Assessment

       3.1.1. Existing Water Monitoring Data for California

Surface and groundwater monitoring data are available for California waters. These data
include United States Geological Survey's (USGS) National Water Quality Assessment
(NAWQA)  and  the  California Department of Pesticide Regulation (CDPR)  Surface
Water Database.  These data are described below.

             3.1.1.1. NAWQA Data (1993-2005) for California

NAWQA monitoring data  are  available for bromacil from  California surface waters
(USGS 2007)  (Table 10).  Samples  were analyzed using HPLC.  Although NAWQA
monitoring does not target specific chemicals, bromacil was  detected in 6.6% of 347
samples from  1993-2005,  with a maximum concentration of 1.9 |ig/L.  Bromacil was
detected in  a  total of 23  samples collected from  5 different sites in  5 counties  in
California.  These counties (Sacramento, Merced, Stanislaus, San Joaquin and  Orange)
also contain CRLF core areas and critical habitat. NAQWA data include information on
the landcover  composition  of the  watershed of the waters from which  samples were
taken. Detection  rates and maximum detections of bromacil in surface water samples are
differentiated in  Table 10 by watershed landcover categories. The sample containing the
maximum concentration of bromacil was collected in January,  1994 in an area receiving
runoff from a landcover classified "mixed."

Table 10. NAWQA 1993 - 2005 data for bromacil detections u in CA SURFACE waters. Data are
distinguished by the landcover (e.g. agricultural, urban, etc.) of the watershed of the sampled water
bodies.
Statistics
Number of samples
Number Detections
% Detects
Maximum Concentration (jig/L)
Agricultural
96
4
4.2%
0.0373
Mixed
179
17
9.5%
1.9
Urban
11
0
0%
0.035
Other
61
2
3.3%
1.43
Total
347
23
6.6%
1.9
 Excludes samples identified by "<", which signify non-detections.
 2Method detection limit = 0.035 ug/L

Groundwater NAWQA monitoring data are also available for bromacil from California
(USGS  2007)  (Table 11).  Samples were analyzed  using  HPLC. From 1993-2005,
bromacil was detected in  5.0% of 402 samples, with a maximum concentration of 0.545
|ig/L. Bromacil was detected in a total of 20 samples collected from 19 different sites in
10 counties in California. These  counties (Colusa, Fresno,  Madera, Merced, Orange,
Riverside, Sacramento, San Bernardino, Stanislaus, and Tulare) also contain CRLF core
areas and critical habitat. The sample containing the maximum concentration of bromacil
was  collected in  May 2000 in an area receiving runoff  from a landcover classified
"mixed."
                                       54

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Table 11. NAWQA 1993 - 2005 data for bromacil detections u in CA GROUND waters. Data are
distinguished by the landcover (e.g. agricultural, urban, etc.) of the watershed of the sampled water
bodies.
Statistics
Number of samples
Number Detections
% Detects
Maximum Concentration (u,g/L)
Agricultural
209
7
3.3%
0.190
Mixed
89
9
10.1%
0.545
Urban
63
1
1.6%
0.0.026
Other
41
3
7.3%
0.081
Total
402
20
5.0%
0.545
 Excludes samples identified by "<", which signify non-detections.
 2Method detection limit = 0.035 ug/L

              3.1.1.2.  California Department  of Pesticide Regulation  Surface Water
                      Database

CDPR maintains a database of monitoring data of pesticides in CA surface waters. The
sampled water bodies include rivers, creeks, urban streams, agricultural drains, the San
Francisco  Bay delta region and  storm  water  runoff from urban areas.  The database
contains data  from  51 different  studies  by federal state and local agencies  as well as
groups from private industry and environmental interests.  Some data reported in this
database are  also reported by  USGS in  NAWQA; therefore,  there is  some overlap
between these  two data sets (CDPR 2007).

From 1992-2002,  1008 samples from CA surface waters were analyzed for bromacil. Of
these, bromacil was detected in 7.7%, with a maximum concentration of 7.5 |ig/L, which
was detected in 1992 in San Joaquin County.  These samples included 65 different sites
from  16 counties;  including counties where CRLF core areas  and critical habitat are
located.

       3.1.2. Modeling Approach

As  stated  above,  the Tier II models  used to  calculate aquatic  EECs  are PRZM and
EXAMS. For this modeling effort, PRZM scenarios designed to represent different crops
and geographic areas of CA are used in conjunction with the standard pond environment
in EXAMS. Use-specific and chemical-specific parameters for the PE4  shell as well as
PRZM scenarios are described below. The PRZM/EXAMS output files generated by this
modeling approach are located in Appendix B.

              3.1.2.1. PRZM scenarios

For modeling aquatic exposures resulting from applications of bromacil use on citrus, the
CA citrus scenario is used.

The CA right-of-way and CA impervious scenarios are used in tandem in order to model
EECs resulting from use of bromacil on non-cropland areas. The rights-of-way scenario
was  developed specifically for  the San Francisco Bay region using the  conceptual
approach developed for the Barton Springs salamander atrazine endangered species risk
assessment (U.S. EPA, 2006).  The San Francisco area was selected to be representative
                                       55

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of urbanized areas with CRLF  habitat present in the general vicinity. The impervious
scenario was developed to represent the paved areas within  a watershed.  The EECs
derived by  PRZM/EXAMS  for  the  two  scenarios are further  refined to be  more
representative of non-cropland areas, specifically  rights-of-way.  These refinements,
termed "post-processing" are described below.

             3.1.2.2. Post-processing of PRZM/EXAMS outputs  to develop EECs for
             non-cropland areas

Although  the non-cropland  classification includes  a wide variety of areas (see Use
Characterization,  Section  2.4.4), rights-of-way are used to represent these areas.
Available  data for California indicate that use of bromacil on rights-of-way represents a
significant portion of the past (2002-2005) use of bromacil (36.3%  of total use).  Of uses
of bromacil on non-cropland areas, 81.0% was applied to rights-of-way (CPUR 2007a).

Rights-of-way are roads, highways, railroads, utilities and pipelines. These areas contain
both impervious (i.e.  cement,  asphalt, metal  surfaces)  and pervious surfaces. It is
assumed that bromacil will be applied to the pervious surfaces, where weeds are expected
to grow. It is also assumed that bromacil is not applied to impervious surfaces in rights-of
way, but that there is a 1% incidental spray onto impervious surfaces in the right-of-way.
Further details  on  how the  1% value  was derived  and characterization of alternative
assumptions  are provided in the  Barton Springs salamander endangered  species risk
assessment for atrazine (U.S. EPA, 2006).

In a standard PRZM scenario, it is assumed that an entire 10 ha field is composed only of
the identified crop, and that the field has uniform surface properties throughout the field.
In a right-of-way, this is not a reasonable assumption, since a right-of-way contains both
impervious  and pervious  surfaces.  Since the two  surfaces have different  properties
(especially different curve  numbers  influencing the  runoff from  the  surfaces) and
different masses of applied bromacil, the standard approach for deriving aquatic EECs is
revised using the following approach:

   1)  Aquatic EECs are derived for the pervious portion of the right-of-way, using the
       maximum use rate  of bromacil on the CArightofway scenario. At this point, it is
       assumed that 100% of the right-of-way is composed of pervious surface. Specific
       inputs for this modeling are defined below.
   2)  Aquatic EECs are derived for the impervious portion of the right-of-way, using
       1% of the maximum use rate of bromacil on  the CAimpervious scenario. At this
       point, it is assumed that 100% of the right-of-way is composed  of impervious
       surface.
   3)  The daily aquatic EECs (contained in the PRZM/EXAMS output file with the
       suffix "TS") are input into a Microsoft® Excel® worksheet.
   4)  Daily aquatic EECs  for the  impervious surface are multiplied by 50%. Daily
       aquatic EECs for the pervious surface are multiplied by 50%. The resulting EECs
       for impervious and pervious surfaces are added together to get an adjusted EEC
       for each day of the 30-year simulation period (Equation 1).
                                       56

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       Equation 1:  Revised EEC = (imperviousEEC * 50%) + (perviousEEC * 50%)

   5)  Rolling  averages for the relevant durations of exposure  (21-day, and 60-day
       averages) are calculated.  The l-in-10 year peak, 21-day and 60-day values are
       used to define the acute and chronic EECs for the aquatic habitat.

In this approach, it is assumed that a right-of-way is composed of equal parts pervious
and impervious  surfaces (i.e. in step 4, the EECs of both surfaces are multiplied by 50%).
This is more likely to be representative of a highway or road right-of-way. It is likely that
right-of-way contain different ratios of the two surfaces.  In general,  incorporation of
impervious surfaces into the exposure assessment results in increasing runoff volume in
the watershed, which tends to reduce overall pesticide exposure  (when assuming  1%
overspray to the impervious surface).

             3.1.2.3. Input Parameters

The  appropriate chemical-specific PRZM/EXAMS input parameters are selected from
reviewed environmental fate data submitted by the registrant (Table 4) and in accordance
with EFED water model  input parameter  selection guidance (U.S. EPA 2002).   A
summary of the chemical specific model inputs used in this assessment are provided in
Table 12

PRZM/EXAMS input parameters specific to uses of bromacil and bromacil lithium on
citrus and non-cropland areas  are described below and are  summarized in Table  13.
Parameters for these uses are determined based on label recommendations.
                                       57

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Table 12. Chemical specific PRZM/EXAMS Input Parameters for deriving aquatic EECs for
bromacil.
Input Parameter
Koc (L/kgoc)
Henry's Law Constant (atm-m3/mol)
Hydrolysis Half -life (days)
Aerobic Soil Metabolism Half-life (days)
Aerobic Aquatic Metabolism Half-life
(days)
Anaerobic Aquatic Metabolism Half-life
(days)
Aqueous Photolysis Half -life (days; pH 7)
Vapor pressure (torr at 25°C)
Solubility in water
(mg/L @ pH 7, 25°C)
Molecular Wt. (g/mol)
Value
32
i.ixio-9
0 (stable)
825
1650
0 (stable)
102
S.lxlO'7
8150
261.12
Source/Comments
Value obtained from SCS/ARS
database; only column leaching data
were available from submitted studies
bromacil RED
MRID 4095 1505
MRID 40951510; input is 3X the
measured half -life value (275 days) to
account for uncertainty in using a
single value, per EFED guidance
default input value of 2X aerobic soil
input, per EFED guidance
conservative assumption in lieu of
data, per EFED guidance
MRIDs 4095 1507
40951508
bromacil RED
10X measured solubility of 815 ppm,
per EFED guidance
bromacil RED
Table 13. Use-specific PRZM/EXAMS Input Parameters for deriving aquatic EECs for bromacil.
Input Parameter
Single Application Rate (kg a.i./ha)
Number of applications per year
Application Interval (days)
CAM
Spray Drift
Application Efficiency
Application Date
Citrus
7.2
1
NA
1
0.01
0.99
January 25
Non-cropland areas:
Rights of Way
17.3
2
14
1
0.01
0.99
January 25
Non-cropland areas:
Impervious
0.1731
2
14
1
0
1
January 25
 1 As noted above, it is assumed that 1% of bromacil applied to the pervious portion of a right-of-way is
 incidentally sprayed onto the pervious surface.
                                            58

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Citrus

According to current labels, the maximum single application rate of bromacil on citrus is
6.4 Ibs a.i./A (7.2 kg a.i./ha). Labels indicate that one maximum application should be
made per year (registrations 352-287, 352-505, 70506-83 and 81927-4).

Labels indicate that bromacil applications should be made beneath and/or between trees.
In PRZM, application methods are defined by the CAM (Chemical Application Method)
values; a CAM value of 1 is used to represent applications to soil with no incorporation.
This value is  selected for representing applications of bromacil to the  areas between
citrus trees.

The labels also indicate that contact of the product with tree foliage should be avoided.
Based on this,  as well as instructions that applications  should be made beneath and/or
between trees, it is unlikely that aerial methods would be employed for applications of
bromacil to citrus. Therefore, the spray drift assumption for ground applications, 1%, is
used in modeling  aquatic EECs.   The accompanying application efficiency of 99% is
used.

The application date is chosen based on label directions which indicate that applications
made in late fall or early winter will have the best results in terms of weed control. The
label also indicates that applications should be made at a time when rainfall (or irrigation)
would occur. Consideration of the meteorological data associated  with  the CA citrus
scenario  indicates  that the  largest  rainfall events  occur  in  January. Based  on this
information, an application date of January 25 was chosen. In actuality, applications of
bromacil can be made any time of the year, and according to available pesticide use data
for California, applications of bromacil to citrus have been made throughout the year.

Non-cropland

According to current labels, the maximum single application rate of bromacil on non-
cropland areas is  15.4 Ibs a.i./A (17.3 kg a.i./ha),  with 2 maximum applications allowed
per year (registration 10088-68).

The minimum application interval is not indicated on this  label. It is assumed that the
pesticide user would apply the pesticide and then wait to  see results. After two weeks, the
pesticide user may then reapply bromacil to the treatment site. Therefore, it is assumed
that a second application may be made 14 days after the other.

To represent applications of bromacil  to rights-of way and to impervious surfaces, a
CAM of 1 is used to represent applications directly to the ground.

The label with the maximum use rate  for non-cropland areas (registration 10088-68)
clearly prohibits applications by aerial methods.  Therefore, the spray drift assumption  for
ground applications, 1% and the accompanying application efficiency of 99% are used in
modeling aquatic EECs.
                                        59

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Label instructions indicate that  applications  of bromacil to non-cropland areas can be
made any time during the year. Consideration of the meteorological data associated with
the CA rightofway and CA impervious scenarios indicates that the largest rainfall events
occur in January. In general, the greater amount of rainfall in a single event, the greater
the EEC in the receiving aquatic habitat. In order to select an application date resulting in
a conservative estimate of exposure of aquatic habitats to bromacil, an application date of
January 25 was chosen.

       3.1.3. Aquatic Modeling Results

PRZM/EXAMS EECs representing l-in-10 year peak, 21-day, and 60-day concentrations
of bromacil in the aquatic environment are located in Table  14.

Table 14. Aquatic EECs from PRZM/EXAMS modeling for maximum application rates of bromacil.
EECs are based on the appropriate PRZM scenario and the standard EXAMS pond.
Use
Citrus
Non-cropland
Scenario
CA citrus
CA rightofway and
CA impervious
Peak EEC
(mg/L)
0.056
2.34
21-day EEC
(mg/L)
0.056
2.33
60 -day EEC
(mg/L)
0.056
2.32
3.2. Terrestrial Exposure Assessment

       3.2.1. Exposure to Plants

TerrPlant is used to calculate EECs for non-target plant species inhabiting dry and semi-
aquatic areas. Parameter values for application rate, drift assumption and incorporation
depth are based upon the use and related application method (Table 15).  A runoff value
of 0.5 is  utilized based on bromacil's solubility, which is  classified by TerrPlant as >100
mg/L.  For ground  application  methods,  a drift assumption  of 1%  is selected. EECs
relevant  to  terrestrial  plants consider pesticide concentrations in  drift  and in runoff.
These EECs are listed by use in Table 15. Output from TerrPlant v.1.2.2 are available in
Appendix C.

Table 15. TerrPlant inputs and resulting EECs for plants inhabiting dry and semi-aquatic areas
exposed to bromacil through runoff and drift.
Use
Citrus
Non-cropland
Application
rate
(Ibs a.i./A)
6.4
15.4
Application
method
ground
ground
Drift
Value
(%)
0.01
0.01
Spray drift
EEC
(Ibs a.i./A)
0.064
0.154
Dry area
EEC
(Ibs a.i./A)
0.32
0.924
Semi-
aquatic
area EEC
(Ibs a.i./A)
3.2
7.85
                                        60

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       3.2.2. Exposures to animals

              3.2.2.1. Modeling Approach

T-REX is used to calculate dietary and dose-based EECs of bromacil for the CRLF and
its potential prey (e.g. terrestrial invertebrates,  small mammals,  terrestrial-phase frogs)
inhabiting terrestrial areas. EECs  used to  represent 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. Foliar dissipation  data are unavailable for estimating a half-life for
bromacil.  As a result, the default  value of 35 days is  used. Use specific input values,
including number of applications, application rate and application interval are located in
Table 16. Outputs for T-REX v. 1.3.1  are available in Appendix D.

Table 16. Input parameters for T-REX used to derive terrestrial EECs for bromacil.
Use
Citrus
Non-cropland
Number of
applications
1
2*
Application rate
(Ibs a.i./A)
6.4
15.4
             *Application interval of 14 days.

              3.2.2.2. Terrestrial Animal Exposure Modeling Results

For modeling purposes, exposures  of the CRLF to bromacil through contaminated food
are estimated using the EECs for the small bird (20 g) which consumes small insects.
Dietary-based EECs calculated by T-REX for small  and large insects (units of jig a.i./g)
are used to bound an estimate of exposure to terrestrial invertebrates. 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 17).

Table 17. Upper-bound Kenega nomogram EECs for exposures of the CRLF and its prey to
bromacil.
Organism
CRLF
small insects (prey)
large insects (prey)
small mammals (prey)
small frogs (prey)
Exposure
Dietary
Dose
Contact
Contact
Dietary
Dose
Dietary
Dose
Units
ppm
mg/kg-bw
ug a.i./g (of insect)
ug a.i./g (of insect)
ppm
mg/kg-bw
ppm
mg/kg-bw
Citrus
EEC*
864
984
864
96.0
1536
1464
864
984
Non-cropland
EEC*
3655
4162
3655
406
6497
6194
3655
4162
 *based on a default foliar dissipation half-life of 35 days.
                                        61

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         3.2.3. Spray Drift Modeling

  In order to determine the extent of terrestrial habitats of concern beyond application sites,
  it is necessary to estimate the distance spray applications can drift from the treated field
  and still be greater than the level of concern. Spray drift modeling was done for animals
  and plants to determine the  farthest  distance  required to  not  exceed the LOG for
  exposures to bromacil drifted to non-target areas. This assessment requires the use of the
  spray  drift model, AgDrift (version 2.01; dated 5/24/2001). In cases where estimates of
  drift  exceed the limits of the  AgDrift model, the  AGDisp  (version  8.13;  dated
  12/14/2004) (Teske and Curbishley,  2003) is  used to simulate aerial  and ground
  applications using the Gaussian farfield extension.

  The Tier I version of AgDrift was  used for simulating applications of bromacil to citrus
  and non-cropland areas by ground methods. It was assumed that a high boom height
  would be used for ground applications. Given that labels did not describe any spray drift
  mitigations, the most conservative  assumption for spray drop size distributions, "ASAE
  very fine to fine" was used to determine the range of possible depositions  of bromacil.
  The maximum single application rate for citrus  (6.4 Ibs  a.i./A) and non-cropland areas
  (15.4  Ibs a.i./A) was used to determine the farthest distance from the edge of field where
  there  are no LOG exceedances for animals or plants (based on point deposition) (Table
  18). AgDrift is useful for estimating point deposition out to 990 feet from the edge of a
  field.  In cases where  estimates of exposure  at  990 feet  estimated  by AgDrift were
  sufficient to exceed the LOG for a taxonomic group, AGDisp was used. The parameters
  used for AGDisp are defined in Table 19, with results in Table 18.

  Table 18. Distance away from edge of field where terrestrial animal and plant LOCs are not
  exceeded by exposures to bromacil through spray drift.
Organism
CRLF
Terrestrial
invertebrates
Terrestrial
mammals
Terrestrial
plants
Exposure
dose-acute
dietary-acute
dietary chronic
acute small
acute large
dose-acute
dose-chronic
dietary -chronic
monocots -drift
dicots -drift
LOC
0.1
0.1
1
0.05
0.05
0.1
1
1
1
1
Point deposition
that does not
exceed LOC
(Ibs a.i./A)
>1.1
>7.5
11
>0.44
>4.0
0.75
0.12
1.04
0.03
0.0047
Distance (in feet) from edge of field
where LOC is not exceeded-results
differ based on Use
Citrus
<16
NA
NA
<39
<3
23
132
17
437
40261
(0.76 mile)
Non-cropland areas
<36
<7
NA
<89
<13
52
292
39
810
59091
(1.12 mile)
NA = not applicable
:990 feet represents the range of AgDRIFT. Any value beyond this distance was calculated using AGDISP.
                                          62

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Table 19. Scenario and standard management input parameters for simulation of bromacil in spray
drift using AgDisp with Gaussian farfield extension.
Parameter Description
Application Method
Nozzle type1
Boom Pressure1
Release height
Spray lines
Nozzles
Droplet Size Distribution
(DSD)
Swath Width
Wind Speed
Wind direction
Air temperature
Relative Humidity
Spray Material
Fraction of active solution that
is non-volatile
Fraction of additive solution
that is non-volatile
Upslope angle
Side slope angle
Canopy type
Surface roughness
Transport
Height for wind peed
measurement
Maximum comp. Time
Maximum downwind distance
Vortex decay rate OGE
Vortex decay rate IGE
Aircraft drag coefficient
Propeller efficiency
Ambient pressure
Ground reference
Evaporation rate
Specific Gravity (non-
volatile)
Parameter Value
for Citrus
Ground
Flat fan
60 Ib
4 feet
20
42
Fine to very fine
60ft
15 mph
-90°
65° F
50%
Water
0.08
0.1
0°
0°
none
0.0246 ft
Oft
6.56 ft
600 sec
2608.24 ft
0.3355
1.25
0.1
0.8
29.91
Oft
84.76 ug-(K-s)'1
1.0
Parameter Value for
Non-cropland
Aerial
NA
NA
15 feet
20
42
Fine to very fine
60ft
15 mph
-90°
65° F
50%
Water
0.0098
1
0°
0°
none
0.0246 ft
Oft
6.56 ft
600 sec
2608.24 ft
0.3355
1.25
0.1
0.8
29.91
Oft
84.76 ug-(K-s)'1
0.939
Comments
Product Labels
Program default
Program default
Program default
Program default
None available
Default; draft guidance
Program default
Default; draft guidance
Default
Program default
Program default
Program default
Product labels
Product labels
Assume flat surface
Assume flat surface
Default from guidance
Program default, none
provided
Program default
Program default
Program default
Program default
Program default
Program default
Program default
Program default
Program default
Program default
Program default
For citrus, assume that
product is dissolved in
water.
1 parameter for ground spray only
NA = Not Applicable
                                            63

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4.     Effects Assessment

This assessment evaluates the potential for bromacil to adversely affect the CRLF.  As
previously  discussed in Section 2.7, 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 and/or modification of its habitat.

Direct effects to the CRLF in aquatic  habitats are based on  toxicity information for
freshwater  vertebrates,  specifically fish, which are generally used  as a  surrogate for
amphibians.  Direct effects to the CRLF  in terrestrial habitats  are based on toxicity
information for birds, which are generally  used  as a  surrogate for terrestrial-phase
amphibians.

Given that the  CRLF's prey items  and habitat  requirements are  dependent  on  the
availability of freshwater aquatic  invertebrates and  aquatic plants, fish, frogs, terrestrial
invertebrates  and terrestrial mammals, toxicity  information for these organisms is 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
bromacil.  A summary of the available freshwater and terrestrial ecotoxicity data relevant
to this assessment is discussed below.

The  focus  of this assessment is on  the technical grade active  ingredient (TGAI) of
bromacil.  Data available for exposures of organisms to formulated products are not used
for deriving RQs, with the exception of instances where no suitable data are available for
exposures of organisms to the TGAI. Effects data are available for exposures of animals
and plants to formulated products containing bromacil or bromacil  lithium. Some of these
data are described in Appendix A.

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 in May 2007, from a search  which included all open
literature data for bromacil and its salts (including lithium, sodium and dimethylamine),
only one of which (lithium)  is still registered  for  use.  In  order  to be included in the
ECOTOX database, papers must meet the following minimum criteria:

   •  the toxic effects are related to single chemical exposure;
   •  the toxic effects are on an aquatic or terrestrial plant or animal species;
   •  there is a biological effect on live, whole organisms;
   •  a concurrent environmental chemical concentration/dose  or  application rate is
       reported;
   •  and there is an explicit duration of exposure.
                                        64

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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. A list of citations accepted and rejected by
ECOTOX and the rational for rejection is available in Appendix G.

This section also includes information related to reported incidents  of ecological effects
associated with bromacil. Available incidents include effects to terrestrial and wetland
plants, as well as effects to fish.

4.1. Evaluation of Aquatic Ecotoxicity Studies for Bromacil

As described in the Agency's Overview Document (U.S. EPA, 2004), the most sensitive
endpoint for each taxa is evaluated.  For this assessment,  evaluated taxa relevant to the
aquatic habitat of the CRLF include freshwater fish, freshwater aquatic invertebrates, and
freshwater aquatic plants.  Currently,  no  guideline tests exist for frogs.   Therefore,
surrogate  species (fish) are  used as  described in the Overview Document (U.S. EPA,
2004) to represent direct exposures to the CRLF in the aquatic habitat. No ecotoxicity
data for amphibians exposed to bromacil are available from the open literature.  Table 20
summarizes the most sensitive aquatic, ecological toxicity endpoints for the CRLF, its
prey and its habitat, based on an evaluation of both the submitted studies and the open
literature, as previously  discussed.  The values presented  in Table  20 are used for
deriving quantitative RQs for this risk  assessment. A  brief summary of submitted  and
open literature  data considered relevant to this ecological risk assessment is presented
below.
                                        65

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Table 20. Summary of most sensitive toxicity for assessing direct and indirect effects of bromacil to
CRLF in aquatic habitats.
Assessment Endpoint
Species
(common name)
End-point
Mean
concentration
(mg/L)
Study
Classification
Ref.
(MRID)
Measures of Direct Effects
Acute toxicity to CRLF
Chronic toxicity to CRLF
Oncorhyncus mykiss
(Rainbow Trout)
Oncorhyncus mykiss
(Rainbow Trout)
LCso
NOAEC
36
3.0
Acceptable
Supplemental
40951503
44566101
Measures of Indirect Effects
Toxicity to unicellular
plants composing aquatic
habitat and representing
prey for tadpole CRLF
Toxicity to multicellular
plants composing aquatic
habitat
Acute toxicity to
invertebrates (prey)
Chronic toxicity to
invertebrates (prey)
Acute toxicity to fish and
frogs representing prey
Acute toxicity to fish and
other species of frogs (prey)
Pseudokirchneriella
subcapitatum
(green algae)
Lemna gibba
(duckweed)
Daphnia magna
(Water Flea)
Daphnia magna
(Water Flea)
Oncorhyncus mykiss
(Rainbow Trout)
Oncorhyncus mykiss
(Rainbow Trout)
ECso
ECso
EC50
NOAEC
LC50
NOAEC
0.0068
0.045
121
8.2
36
3.0
Supplemental
Acceptable
Acceptable
Acceptable
Acceptable
Supplemental
42516401
46095401
40951504
44566401
40951503
44566101
Acute toxicity to aquatic fish and invertebrates is categorized using the system shown in
Table 21 (U.S. EPA, 2004).  Based on thesecategories  bromacil is  classified slightly
toxic to practically nontoxic to freshwater fish and invertebrates, respectively, on an acute
exposure  basis.  Toxicity categories for  aquatic  plants have  not  been  defined.  If
classification for animals were applied  to  aquatic plants, bromacil  would be classified
very highly toxic to unicellular and vascular plants.

Table 21. Categories of Acute Toxicity for Aquatic Animals.
LC50 (mg/L)
<0.1
>0.1-1
>1-10
> 10 - 100
>100
Toxicity Category
Very highly toxic
Highly toxic
Moderately toxic
Slightly toxic
Practically nontoxic
                                         66

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       4.1.1. Toxicity to freshwater fish

Acute exposures

Registrant  submitted studies  are  available  for acute  exposures  of  rainbow trout
(Onchoryhnchus mykiss) and bluegill sunfish (Lepomis macrochirus) to bromacil.  One
data point is  available in ECOTOX for acute exposure of a freshwater fish to bromacil.
This value, which is reported  as  a 96-h LCso of 186  mg/L  for  fathead minnows
(Pimephales promelas)  (Geiger et al. 1988), represents  a less conservative value than
registrant-submitted  data.    Therefore, this value  is not  considered  further in this
assessment.

The available registrant-submitted  study involving rainbow trout was a static, 96-h
exposure, resulting in a  LCso of 36 mg/L (95% confidence interval:  30-40 mg/L). This
LC50 value represents the most sensitive endpoint available for acute exposures offish to
bromacil. Sublethal effects observed in surviving fish exposed to 22.5 mg/L bromacil and
higher included loss of equilibrium, swollen appearance and sinking to the bottom of test
vessels. No effects were  described at 16.9 mg/L (MRID 40951503).

The registrant-submitted study involving bluegill sunfish was a static, 96-h exposure,
resulting in a LCso of 127 mg a.i./L. Sublethal effects observed in surviving fish exposed
to 95 mg/L bromacil and higher included loss of equilibrium. No effects were described
at 71 mg/L (MRID 409515-02).

Chronic exposures

Data are available from a registrant-submitted study where rainbow trout were exposed to
bromacil for  90 days in  a flow-though study.  The NOAEC and LOAEC values for this
study were 3.0 and 7.2 mg a.i./L, respectively, based on treatment-related effects to mean
wet weight, which was the only measured endpoint that was affected. At the highest test
concentration (7.2 mg a.i./L), measured wet weights of juvenile fish were 32.4% lower
than controls. No treatment related effects on survival were observed in any of the
treatment groups (maximum of 7.2 mg a.i./L).  This  study is  scientifically sound,  but is
classified supplemental, due to  excessive variation in measured concentrations  of
bromacil in the treatment levels (MRID 44566101).

No data are available in ECOTOX for chronic exposures offish to bromacil.

       4.1.2. Toxicity to freshwater invertebrates

Acute exposures

A registrant-submitted study is available for acute exposures  of freshwater invertebrates
to bromacil.  Data are also  available in ECOTOX  for  acute exposures  of freshwater
invertebrates to bromacil.
                                       67

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The available registrant-submitted study involving waterflea (Daphnia magnd) was  a
static, 48-h exposure, resulting in an ECso of 121 mg/L (95% confidence interval:  111-
148 mg/L), based on immobility. Effects were observed at 111 and 148 mg/L (20% and
100% immobility, respectively, with no effects described at 83 mg/L (MRID 409515-04).
This ECso value is used in this risk assessment for quantifying RQ values for acute
exposures of aquatic invertebrates to bromacil.

ECOTOX  includes  data  for  a  study   involving  48-h  exposures  of  waterfleas
(Ceriodaphnia dubid) to bromacil.  Resulting ECsovalues, based on immobility, were 65
mg a.i./L (95% confidence interval: 56-75 mg a.i./L) for exposures in laboratory water
and 75  mg  a.i./L  (95% confidence interval: 63-88  mg a.i./L) for  exposures in field-
collected water (Foster et al. 1998). Due to insufficient data available in the publication,
(including raw data) the acceptability of this study could not be evaluated.  Therefore,
these data are not utilized for quantifying RQ values representing acute  exposures  of
aquatic invertebrates to bromacil. As published, these EC50 values represent lower values
than the value used for deriving RQs, so, these data are used at face value to characterize
potential risk of aqueous exposures of bromacil to aquatic invertebrates (see section
5.2.2).

Chronic exposures

Data are available  from a registrant-submitted study  where waterfleas (D.  magnd) were
exposed to bromacil for 21 days.   The NOAEC and  LOAEC values for this study were
8.2 and 21 mg a.i./L, respectively, based on treatment-related effects to reproduction and
growth.  In the 21 mg a.i./L treatment level, adults did not produce offspring. Also, at that
treatment  level, adults had  significantly  reduced  body  lengths and  dry  weights  in
comparison to organisms in the negative control  (13%  and 45% decreases, respectively;
MRID 44566401).

No data are available in ECOTOX for chronic exposures of freshwater invertebrates to
bromacil.

       4.1.3. Toxicity to aquatic plants

Unicellular plants

Data relevant to exposures of unicellular,  aquatic plants to bromacil are available from
several registrant submitted studies. No data are available in  ECOTOX for exposures of
aquatic, unicellular plants to technical bromacil.
Registrant-submitted studies  for  algae  and diatoms (unicellular plants) include
values ranging 6.8-69.9 jig a.i./L,  based on decreased cell density. Effects were observed
at exposures of green algae at the lowest bromacil concentrations tested, i.e.,  1.1 ng a.i./L
(Table 22)
                                        68

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Table 22. EC50 and NOAEC values from registrant submitted studies involving exposures of
bromacil to unicellular, aquatic plants.
Species
(common name)
Pseudokirchneriella
subcapitatum (green algae)
Navicula pelliculosa
(Freshwater diatom)
Skeletonema cosatum
(marine diatom)
Anabaena flos-aquae
(Blue-green algae)
EC50*
units: jig a.i./L
(95% C.I.)
6.8 (5.9-7.8)
6.91 (5.59-8.54)
12.1(8.3-17.6)
69.9(54.2-90.1)
NOAEC
Oiga.i./L)
<1.1
3.39
5.5
11.2
Study
Classification
Supplemental
Acceptable
Acceptable
Acceptable
Ref. (MRID)
42516401
44218501
44218503
44218502
                          *Effects based on decreased cell density.
Vascular plants

Data are available from a registrant-submitted study where duckweed (Lemna gibba) was
exposed to bromacil for  14 days.  The NOAEC and EC50 values based on decrease in
frond number were 17 and 45  ug a.i./L, respectively.  Effects to dry weight were also
observed during this study (MRID 46095401) albeit at higher concentrations. No data are
available in ECOTOX for exposures of aquatic vascular plants to bromacil.
4.2. Evaluation of Terrestrial Ecotoxicity Studies for Bromacil

As described in the Agency's Overview Document (U.S. EPA, 2004), the most sensitive
endpoint for each taxa is evaluated.  For this assessment,  evaluated taxa relevant to the
terrestrial habitat of the CRLF include birds, terrestrial insects, mammals and terrestrial
plants.  Currently, no guideline  tests exist for terrestrial-phase amphibians.  Therefore,
surrogate species (birds) are used as described in the Overview Document (U.S. EPA,
2004) to represent direct exposures to the CRLF in the terrestrial habitat. No ecotoxicity
data for amphibians exposed to bromacil are available from the open literature.  Table 23
summarizes the most sensitive terrestrial, ecological toxicity endpoints for the CRLF, its
prey and its habitat, based on an evaluation of both the registrant-submitted studies and
the  open literature,  as previously discussed. The values presented in Table 23 are used
for  deriving quantitative RQs for this risk assessment. A brief summary of registrant-
submitted and open literature data considered relevant to this ecological risk assessment
is presented below.
                                        69

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Table 23. Summary of most sensitive toxicity for assessing direct and indirect effects of bromacil to
CRLF in terrestrial habitats.
Assessment Endpoint
Species
(common name)
End-
point
Mean
concentration
Study
Classification
Ref.
(MRID)
Measures of Direct Effects
Acute toxicity to CRLF
Sub-acute toxicity to CRLF
Chronic toxicity to CRLF
Colinus virginianus
(Northern bobwhite
quail)
Colinus virginianus
(Northern bobwhite
quail)
Colinus virginianus
(Northern bobwhite
quail)
LD50
LC50
NOAEC
>2250 mg/kg
>10,000 mg/kg-
diet
1550 mg/kg-diet
Acceptable
Supplemental
Acceptable
40951501
00013295
44844801
Measures of Indirect Effects
Acute toxicity to
invertebrates (prey)
Acute toxicity to mammals
(prey)
Chronic toxicity to
mammals (prey)
Acute toxicity to frogs
representing prey
Sub-acute toxicity to frogs
representing prey
Chronic toxicity to other
species of frogs (prey)
Toxicity to monocot plants
composing wetland and
terrestrial habitat
Toxicity to dicot plants
composing wetland and
terrestrial habitat
Apis mellifera
(Honey bee)
Rattus norvegicus
(laboratory rat)
Rattus norvegicus
(laboratory rat)
Colinus virginianus
(Northern bobwhite
quail)
Colinus virginianus
(Northern bobwhite
quail)
Colinus virginianus
(Northern bobwhite
quail)
Triticum aestivum
(wheat)
Brassica napus
(rape)
LD50
LD50
NOAEL
LD50
LD50
NOAEC
EC25
EC25
>1209
uga.i./g(ofbee)
8 12 mg/kg
250 mg/kg-
diet/day
>2250 mg/kg
>10,000 mg/kg-
diet
1550 mg/kg-diet
0.030 Ibs ai./A1
0.042 Ibs a.i./A2
0.0047 Ibs ai./A1
0.0055 Ibs a.i./A2
Supplemental
Acceptable
Acceptable
Acceptable
Supplemental
Acceptable
Supplemental
Supplemental
00018842
44196209
41804601
40951501
00013295
44844801
44488307
44488307
                           1 based on effects to seedling emergence
                             2based on effects to vegetative vigor
Similar to toxicity categories for aquatic organisms, categories of acute toxicity ranging
from  "practically nontoxic" to "very highly toxic" have been established for terrestrial
organisms based on LDso values (Table 24), and  avian species based on LDso values
(Table 25).   Subacute  dietary toxicity for avian species  is based on the LCso values
                                          70

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(Table 26). Based on these categories,  bromacil  is practically nontoxic  to birds and
slightly toxic to mammals on an acute exposure basis.

Table 24. Categories for mammalian acute toxicity based on median lethal dose in mg per kilogram
body weight (parts per million).
LD50 (mg a.i./kg)
<10
10-50
51-500
501-2000
>2000
Toxicity Category
Very highly toxic
Highly toxic
Moderately toxic
Slightly toxic
Practically non-toxic
Table 25. Categories of avian acute oral toxicity based on median lethal dose in milligrams per
kilogram body weight (parts per million).
LD50 (ppm)
<10
10-50
51-500
501-2000
>2000
Toxicity Category
Very highly toxic
Highly toxic
Moderately toxic
Slightly toxic
Practically non-toxic
Table 26. Categories of avian subacute dietary toxicity based on median lethal concentration in
milligrams per kilogram diet per day (parts per million).
LC50 (ppm)
<50
50-500
501-1000
1001-5000
>5000
Toxicity Category
Very highly toxic
Highly toxic
Moderately toxic
Slightly toxic
Practically non-toxic
                                           71

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       4.2.1. Toxicity to birds

Acute

Data are available from a registrant-submitted study,  where bobwhite  quail (Colinus
virginianus) were given acute, oral  doses  of bromacil. No mortalities  were observed
during the  14-day  study period, which resulted in a LDso >2250 mg/kg (highest dose
tested).  Between days 0 and 3, reduced body weight gains in relation to the control were
observed at the two highest test doses, resulting in a NOAEL of 810 mg/kg. At 1350
mg/kg, body weight gains in female birds were 5.1% lower than controls. At 2250 mg/kg,
body weight gains in female and male birds were decreased 4.7  and 5.4%, respectively,
when compared to controls. By the end of the study, body weight gains  of females and
males were similar in all treatment groups, including controls (MRID 40951501).

No data are available for sub-acute dietary  exposures of birds to technical bromacil. In
lieu of toxicity data for technical grade bromacil,  available data from a study involving
dietary-based exposures of birds to  a formulated product (Hyvar® X Bromacil Weed
Killer, 80% a.i.) of bromacil are used in this assessment.  In  this study, mallard ducks
(Anas platyrhynchos) and  bobwhite quail  were  exposed  to  a  formulated product of
bromacil (83.4% a.i.) through dietary exposures. The resulting 8-d LC50 values for both
species  exceeded the  highest  concentration  tested, i.e.,  >10,000 mg/kg-diet/day (of
bromacil).  No mortalities  were observed in  exposures involving  mallard  ducks.
Bobwhite quail  mortalities were observed in exposures  involving several different
treatment levels; however, the mortalities  were  less than 50% of individuals in each
treatment group. In the test, 6.8% mortality was observed in controls, 10% mortality was
observed in the 464 and 4640 mg/kg-diet/day treatment levels and 20% mortality was
observed in the  2150 and  10,000 mg/kg-diet/day treatment levels (MRID 00013295).
This study is classified acceptable for a formulated product, but  supplemental for use in
this assessment, since the test material was not technical bromacil.

No toxicity data are available in ECOTOX for acute exposures of birds to bromacil.

Chronic

Data are available  from two  registrant-submitted studies, where bobwhite quail and
mallard ducks were given  chronic (21 weeks), dietary exposures of bromacil.   In the
study involving Northern  bobwhite quail, effects  to hatchability,  embryo viability,
embryo survival and hatching  survival were observed at 3100 mg/kg-diet/day, resulting
in a NOAEC of 1550  mg  a.i./kg-diet/day (MRID 44844801).   In the  study involving
mallard ducks, significant effects were observed in egg shell  thickness  at the 3100 mg
a.i./kg-diet/day treatment  level. Significant effects to hatchability of  mallards  were
observed at the 6200 mg a.i./kg-diet/day treatment level. The NOAEC for this study was
also 1550 mg a.i./kg-diet/day (MRID 44844601).
                                       72

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       4.2.2. Toxicity to mammals

Acute

Data  are  available from  a  registrant-submitted study,  where laboratory  rats (Rattus
norvegicus) were given acute oral doses of technical grade bromacil. Mortalities were
observed in animals dosed with 1000 and 2000 mg/kg, which resulted in an acute oral
LD50  of 812 mg/kg for females and 1682 mg/kg for males.  Sublethal effects that were
observed included: hunched posture, ataxia, lethargy, decreased respiration, hemorrhagic
lungs, and dark liver and kidneys (MRID 44196209). No data are available in ECOTOX
for acute exposures of mammals to bromacil.

Chronic

Data are available from a 2-generation dietary exposure reproduction study in rats.  The
reported  NOAEL  was 250  mg/kg-diet/day, with a LOAEC  of  2500 mg/kg-diet/day.
Observed effects included  decreased growth (body weight reductions) in parent and first
and second generation offspring (MRID 41804601).  The results  of this study (i.e. the
NOAEL)  are used to derive RQs for  mammals representing prey of the terrestrial phase
CRLF.

ECOTOX includes data from a study in which laboratory rats were exposed to bromacil
in the diet for 2 years. The reported NOAEL was 250 mg/kg-diet/day.  The LOAEL of
1250  mg/kg-diet/day was  based on observed decrease  in body weight  gains and  food
consumption (Sherman and Kaplan  1975).  These results  are consistent  with  those
included in MRID 41804601.

       4.2.3. Toxicity to terrestrial insects

Data are available on the acute toxicity of bromacil to honey bees (Apis melliferd). In an
acute contact toxicity study, the LDso was higher than the highest dose tested, i.e., >11  jig
a.i./bee (MRID 00251374). In  another study involving 96-h acute contact exposures of
honeybees to  a formulated  product  containing bromacil (Hyvar® X  Bromacil Weed
Killer, 80% a.i.),  the LC50 was  >193.38  |ig/bee (MRID  00018842). At this level, 1.2%
mortality  was  observed. Adjustment  of  this value for the %  a.i. of the test substance
results in  an LD50 >155 jig a.i./bee. This toxicity value is converted to units  of jig a.i./g
(of bee) by multiplying by 1 bee/0.128 g thereby  resulting in an LD50 >1209 jig a.i./g.
No data are available in ECOTOX for exposures of insects to technical grade bromacil.

       4.2.4. Toxicity to terrestrial plants

Toxicity data  were submitted from  seedling emergence and vegetative vigor studies
involving separate exposures of wheat (monocot) and rape (dicot) to technical bromacil
and technical bromacil lithium.
                                       73

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In the  seedling emergence  tests  involving bromacil and bromacil  lithium,  percent
survival, dry weight and plant height were significantly affected in both wheat and rape.
The % inhibition in seedling emergence in the treated species as compared to the control
ranged from -11 to 5% for bromacil and from -5 to 13% for bromacil lithium. The most
sensitive endpoint for wheat and rape  in the seedling emergence tests was dry weight.
The  following abnormalities were noted for bromacil:  slight growth  retardation,
malformations, chlorosis and necrosis. The following abnormalities were  noted for
bromacil lithium:  slight to moderate chlorosis, slight to severe growth retardation, slight
unusual pigmentation and slight to severe burn or necrosis. NOAEC, £€25 and ECso
values for bromacil and bromacil lithium exposures t indicate that the two chemicals are
of similar toxicities to wheat and to rape (MRTD 444883-07; Table 27).

Table 27. Comparison of seedling emergence endpoints1 for wheat and rape exposed to bromacil and
bromacil lithium.
Endpoint
NOAEC
EC25
EC50
Wheat
Bromacil
0.020
0.030
0.085
Bromacil Lithium
0.020
0.034
0.087
Rape
Bromacil
0.006
0.0047
0.013
Bromacil Lithium
0.006
0.010
0.013
   :Based on decreased dry weight.
In the vegetative vigor tests, the plant dry weight and plant height were affected by
exposures to bromacil and bromacil lithium. The most sensitive endpoint for wheat and
rape in the vegetative vigor tests was dry weight. The following abnormalities were noted
in tests where plants were exposed to bromacil or bromacil lithium: chlorosis, necrosis
and  growth retardation.  NOAEC, £€25 and ECso values for bromacil and bromacil
lithium exposures indicate that the two chemicals are of similar toxicities to wheat and to
rape (MRID 444883-07; Table 28).

Table 28. Comparison of vegetative vigor endpointsl for wheat and rape exposed separately to
bromacil and bromacil lithium.
Endpoint
NOAEC
EC25
EC50
Wheat
Bromacil
0.020
0.042
0.068
Bromacil Lithium
0.001
0.028
0.065
Rape
Bromacil
0.006
0.0055
0.010
Bromacil Lithium
0.003
0.0060
0.010
   :Based on decreased dry weight.
4.3. Incident Reports

A search  of the EIIS  (Environmental  Incident Information  System)  database  for
ecological incidents (run on September 21, 2007) identified are a total of 32  incidents
associated with bromacil that were reported from  1992-2005. No incidents are identified
in EIIS in association with bromacil lithium. Incidents included in EIIS are defined by a
certainty index associated with the likelihood that the pesticide application described
resulted in the observed incident.  The certainty index defines  incidents as unrelated,
unlikely, possible, probable and  highly probable. One notable  source  of  uncertainty
                                        74

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associated with the EIIS database is the nature of reporting of incidents.  Many more
incidents may have occurred due to bromacil exposures but may not have been reported
due to various factors, such as  a lack of reporting,  or a lack of witnessing of effects.
Therefore,  the lack of an incident report does not necessarily indicate a lack  of an
incident.

The majority (27) of the incidents associated with bromacil involve damage to terrestrial
plants.  These incidents  are  summarized  in  Table 29.  These  incidents involved
applications classified as "misuse" and as "registered use." The certainty index associated
with  all of the incidents was  defined as  either "possible," "probable"  or "highly
probable." These incidents reported observed effects to individual plants, including trees,
effects to lawns, and effects to crops covering areas greater than 100 acres. In some cases,
other herbicides where applied along with bromacil (e.g. diuron, atrazine, metolachlor).
Reports indicated that bromacil  exposures occurred through direct treatment of areas,
spray drift, runoff and carryover from one season to the next.

In addition, 5 of the  incidents  associated with bromacil involved mortalities of  fish
(Table 30). Of these 5 incidents reporting fish kills, 3 reported combined exposures of
fish to 2,4-D and bromacil, 1 reported combined exposures offish to copper and bromacil
and  1  reported exposures of fish to  bromacil only.  This last report (# 1008956-001)
involved an incident where bromacil was dumped into a storm drain, which discharged to
a local  river.  The  certainty of  this incident  in relation to  bromacil was  "probable."
However, this incident was classified as misuse which is not a component of the federal
action         under          review         in          this           assessment.
                                        75

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     Table 29. Summary of reported incidents involving terrestrial plants in relation to applications of bromacil.
Incident ID
1013884-004
1010837-045
1008184-001
1010837-055
1012457-012
1012684-012
1010837-020
1012457-017
1012457-013
1008441-001
1010837-048
10144700-001
1016569-001
1010837-030
1015360-001
1013850-001
1014409-062
1014177-001
1012457-019
1013587-020
1015382-001
1012708-001
1010837-031
1005972-001
1005075-001
1006010-003
1016610-001
Use Site
Home,
exterior
N/R
N/R
N/R
Peanut
Peanut
corn
N/R
Peanut
Fence row
corn
Right-of-
way, utility
Residential
N/R
Driveway
Right-of-
way, rail
N/R
Citrus
Peanut
Right-of-way
Residential
area
Plants
N/R
PLANT
SITE
PASTURE
Utility plant
lawn
Plants affected
yard
corn
trees
soybeans
peanuts
peanuts
corn
peanuts
peanuts
Trees and turf
corn
sod
Willow trees
sunflowers
Trees (pine and
deciduous)
Back yard
Trees and
shrubs
Bell peppers
peanut
Evergreen trees
Trees and grass
Oaks (mature),
shrubs, plants
sunflower
Mature oaks
Alfalfa, oats,
hay
Pasture grass
and bullrush
Trees (pine,
cottonwood,
willow) and
grass
Date
4/22/98
7/13/00
8/19/98
6/19/00
5/28/01
5/29/01
6/7/00
5/20/01
5/29/01
1 1/6/98
7/10/00
5/1/04
7/25/05
6/27/00
8/24/04
5/24/02
7/3/92
3/15/02
6/4/01
3/2/98
6/25/04
6/1/01
6/27/00
9/1/97

8/19/97
9/1/03
Legality
Registered use
Undetermined
Undetermined
Undetermined
Undetermined
Registered use
Undetermined
Undetermined
Undetermined
Undetermined
Undetermined
Registered use
Undetermined
Undetermined
Misuse
(accidental)
Registered use
Undetermined
Registered use
Undetermined
Registered use
Undetermined
Undetermined
Undetermined
Registered use
Misuse
(accidental)
Misuse
(accidental)
Misuse
(intentional)
Certainty
Highly
Probable
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Possible
Probable
Probable
Probable
Probable
Probable
Probable
Probable
State
WA
NY

PA

VA
PA
OK
GA
KY
NY
OK
NM
SD
OR
MI
WA
CA
GA
WA
WY
FL
SD
TX
TX
MS
ID
County
Grant
Wyoming

Huntington
Isle of
Wight
Sussex
Bradford
Beckham
Mitchell
Mason
Steuben
Carter
San Juan
Douglas
Grant
Washtenaw
Benton
Riverside
Grady
Adams

Polk
Douglas



Elaine
Total Magnitude
Not given
ALL
UNKNOWN
35 ACRES
52.5 acres
40 acres
ALL
30 acres
102.7 acres
unknown
ALL
Not given
45 (number)
ALL
3 (number)
1/3 of backyard
Not given
30 acres
88.7 acres
N/R
N/R
40 trees
ALL
3 (number)
3 Acres
unknown
Various
Appl. Rate
N/R
N/R
N/R
N/R
N/R
N/R
N/R
N/R
N/R
N/R
N/R
12 LB/
acre
N/R
N/R
8 Ibs/acre
N/R
N/R
N/R
N/R
N/R
N/R
N/R
N/R
N/A
N/R
N/R
4 pounds
Exposure route
Drift and runoff
Treated directly
Drift
Treated directly
Treated directly
Treated directly
Treated directly
Treated directly
Treated directly
Runoff
Treated directly
runoff
Spray
carryover
N/R
Spray
N/R
carryover
Treated directly
drift
runoff
Direct treatment
carryover
runoff
unknown
runoff
Direct treatment
Other pesticides
diuron
atrazine, metolachlor
NR
atrazine, metolachlor
s-metolachlor,
flumioxazin
s-metolachlor,
flumioxazin
atrazine, metolachlor
flumioxazin
flumioxazin
NR
atrazine, metolachlor
diruon
diuron
Dicamba, 2,4-D,
primisulfuron-methyl
diuron
2,4-D, dimethylamine,
diuron, glyphosate,
isopropylamine salt
Diuron, oryzalin
diuron
Ethalfluralin, flumioxazin
diuron
diuron

Dicamba, 2,4-D,
primisulfuron-methyl
Diuron, sulfometuron,
imazapyr
diuron
Diuron, glyphosate,
isopropylamine salt,
sulfometuron
diuron
N/R = not reported
                                                                          76

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Table 30. Summary of reported incidents involving fish kills in relation to applications of bromacil.
Incident ID
1004875-001
1007154-001
1008956-001
1004668-001
1003601-001
Use Site
N/R
Utility plant
Sewer disposal
N/R
stream
Type of Fish
N/R
N/R
N/R
N/R
White sucker,
minnow, eel,
dace
Date
3/10/96
3/18/98
1/1/94
3/10/96
6/22/93
Legality
Misuse
(intentional)
Registered use
Misuse
(intentional)
Misuse
(accidental)
Registered use
Certainty
Highly
Probable
Possible
Probable
Probable
Probable
State
LA
MS
IA
LA
DE
County
East
Baton
Rouge


East
Baton
Rouge
New
Castle
# fish killed
Hundreds
(along 1.6
mile stretch
of creek)
some
Unknown
600
1000
Appl.
Method
Leaking
drum
Soil
incorporation
Dumped into
drain
spill
Surface
application
Other
pesticides
2, 4-D
Diuron, copper
sulfate
N/R
2,4-D
2, 4-D
Product

KROVAR I DF
FENOCIL III

N/R
N/R = not reported
                                                                      77

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5.     Risk Characterization

Risk characterization is the integration of the exposure and effects characterizations to
determine the potential ecological risk from varying bromacil and bromacil lithium use
within the action area and to determine likelihood of direct and indirect effects on the
CRLF. The risk characterization provides estimation and description of the likelihood of
adverse effects; it articulates risk assessment assumptions, limitations, and uncertainties;
and  synthesizes an overall  conclusion  regarding the effects determination (i.e.,  "no
effect," "likely to adversely affect," or "may affect, but not likely to adversely affect") for
the CRLF.

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 risk levels of
concern (LOCs) for each category evaluated (Appendix F).  For acute exposures to the
CRLF and its animal prey in aquatic habitats, as well as terrestrial invertebrates, the acute
risk to endangered species LOG is 0.05. For acute exposures to the CRLF  and mammals,
the acute risk to endangered species LOG is 0.1.  The LOG for chronic risk to CRLF and
its prey, as well as acute risk to plants is  1.0. As discussed in the analysis plan of the
problem formulation (specifically, section 2.10.1.3), the acute risk to non-listed  species
LOG value for animal prey, which is 0.5, is also used for evaluating RQs.

Screening-level RQs are based on the most sensitive endpoints and modeled EECs from
the following scenarios for bromacil:

   •   Use on citrus @ 6.4 Ibs a.i./A; 1 application per year
   •   Use on non-cropland areas @  15.4 pound a.i./A; 2 applications per year

For  exposures  of terrestrial  plants  inhabiting  dry and semi-aquatic habitats, single
maximum applications of use on citrus and non-cropland areas were modeled,  based on
the application rates listed above.

       5.1.1. Exposures in the Aquatic Habitat

              5.1.1.1. Direct Effects to CRLF

For assessing acute risks  of direct  effects to the larval  and juvenile and adult CRLF
inhabiting water, l-in-10 year peak EECs in the  standard pond are used with the lowest
acute toxicity value for fish. For chronic risks, l-in-10 year peak 60-day EECs and the
lowest chronic  toxicity value for fish are used. Resulting RQs exceed the acute risk to
listed species LOG (RQ>0.05) for applications to non-cropland areas. RQs do not exceed
the acute or  chronic risk LOCs for  applications  to citrus or the  chronic risk  LOG for
applications to non-cropland areas (Table 31).
                                        78

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Table 31. RQ values for acute and chronic exposures directly to the CRLF in aquatic habitats.
Use
Citrus
Non-cropland
Peak EEC
(mg/L)
0.056
2.34
60-d EEC
(mg/L)
0.056
2.32
Acute CRLF
RQ1
0.01
0.0653
Chronic
CRLF RQ2
0.02
0.77
       'Calculated using LC50=36 mg/L.
       Calculated using NOAEC = 3 mg/L.
       3Exceeds acute, listed species LOC (0.05).

              5.1.1.2 Indirect Effects to CRLF through effects to organisms composing
              diet (i.e. prey)

For assessing risks of indirect effects of bromacil to the aquatic-phase CRLF (tadpoles)
through effects to its diet, l-in-10 year peak EECs from the standard pond are used with
the lowest acute  toxicity  value for aquatic unicellular plants to derive RQs. Resulting
RQs exceed the acute risk LOC (RQ>1.0) for aquatic plants from bromacil applications
citrus and non-cropland areas (Table 32).

Table 32. RQ values for exposures to unicellular aquatic plants (diet of CRLF in tadpole life stage).
Use
Citrus
Non-cropland
Peak EEC
(mg/L)
0.056
2.34
Unicellular
Plant RQ1
8.242
3442
                    'Calculated using EC50=0.0068 mg/L.
                    2 Exceeds aquatic plant LOC (1.0).

For assessing risks of indirect acute effects to the aquatic-phase CRLF through effects to
prey (invertebrates) in aquatic habitats, l-in-10 year peak EECs in the standard pond are
used with the lowest acute toxicity value for invertebrates. For chronic risks, l-in-10 year
peak 21-day EECs and the lowest chronic toxicity value for invertebrates are used to
derive RQs.  Resulting RQs do not exceed the acute  and chronic risk to listed species
LOC (RQ>0.05 and >1.0, respectively) for applications to citrus and non-cropland areas
(Table 33)

Table 33. Risk Quotient (RQ) values for acute and chronic exposures to aquatic invertebrates (prey
of CRLF juveniles and adults) in aquatic habitats.
Use
Citrus
Non-cropland
Peak EEC
(mg/L)
0.056
2.34
21-d EEC
(mg/L)
0.056
2.33
Acute Invert
RQ1
O.01
0.02
Chronic
Invert RQ2
0.01
0.28
       'Calculated using EC50=121 mg/L.
       Calculated using NOAEC = 8.2 mg/L.

Fish and frogs also represent prey of CRLF. These RQs are represented by those used for
direct effects to the CRLF  in  aquatic habitats (Table 31). RQs for non-cropland areas
exceed the acute risk LOC  for listed animals (RQ>0.05), but not for non-listed animals
(RQ>0.5).   The  chronic  risk LOC for non-listed and  listed  animals (RQ>1.0) is not
                                         79

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exceeded for non-cropland areas. RQs for citrus do not exceed the acute or chronic risk
LOCs for non-listed and listed fish and frogs.

              5.1.2.3. Indirect Effects to CRLF through effects to habitat (plants)

For assessing risks  of indirect effects of bromacil to the aquatic habitat (plants) the 1-in-
10 year peak EECs from the standard pond  are used with the lowest acute toxicity value
for aquatic unicellular plants and for aquatic vascular plants to derive RQs. Resulting
RQs exceed  the LOG (RQ>1.0) for both unicellular  and vascular aquatic plants  from
bromacil applications to citrus and non-cropland areas (Table 34).

Table 34. RQ values for exposures of aquatic plants to bromacil.
Use
Citrus
Non-cropland
Peak EEC
(mg/L)
0.056
2.34
Unicellular
Plant RQ1
8.23
3443
Vascular
Aquatic Plant
RQ2
1.23
523
             'Calculated using EC50=0.0068 mg/L.
             Calculated using EC50=0.045 mg/L.
             3 Exceeds aquatic plant LOC (1.0).
       5.1.2. Exposures in the Terrestrial Habitat

              5.1.2.1. Direct Effects to CRLF

As described above, to assess risks of bromacil to terrestrial-phase CRLF, dietary-based
and dose-based  exposures modeled in T-REX for a small bird (20g) consuming small
invertebrates are used. Acute, subacute and chronic effects are estimated using the lowest
available toxicity data for birds. EECs are divided by toxicity values to estimate acute
and chronic dietary-based RQs as well  as dose-based RQs.

For use on citrus, indiscreet, dose-based RQs potentially exceed the LOC.  Acute and
chronic, dietary-based RQs  for use on citrus do not exceed the LOC. For use on non-
cropland areas, the LOC is potentially exceeded by RQs for dose-based and dietary-based
exposures (Table 35).

Table 35. RQ values for exposures of terrestrial-phase CRLF to bromacil. RQs estimated using T-
REX.
Exposure
Dose-acute
Dietary-acute
Dietary -chronic
Toxicity Value
LD50>2250 mg/kg
LC50>10,000 mg/kg-diet
NOAEC = 1550 mg/kg-diet
Citrus
RQ
O.611
O.09
0.56
Non-cropland
RQ
<2.6'
O.371
2.362
      1 since this RQ is indiscreet, it potentially exceeds the acute listed species LOC of 0.1
      2exceeds chronic, listed species LOC (1.0)
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              5.1.2.2. Indirect Effects to CRLF through effects to prey

In order to assess the risks to terrestrial invertebrates, which are considered prey of CRLF
in terrestrial habitats, the honey bee is used as a surrogate for terrestrial invertebrates. As
described earlier,  the  toxicity value for terrestrial  invertebrates  is calculated  by
multiplying the lowest available acute contact LD50 of >155 jig a.i./bee by 1 bee/0.128 g,
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 >1209 jig a.i./g of bee.   The resulting RQ values for
large insect and small  insect  exposures bound the  potential  range of exposures  for
terrestrial insects from the use of bromacil. For all uses, RQ values  potentially exceed the
LOC (RQ>0.05) for both large and small terrestrial insects (Table 36).

Table 36. RQ values for exposures of terrestrial animals to bromacil. RQs estimated using T-REX.
Organism
small insects
(prey)
large insects
(prey)
small mammals
(prey)
small frogs
(prey)
Exposure
Acute Contact
Acute Contact
Dose-acute
Dose-chronic
Dietary-chronic
Dose-acute
Dietary-acute
Dietary-chronic
Toxicity Value
LD50>1209 ug a.i./g
LD50>1209 ug a.i./g
LD50=812mg/kg
NOAEC = 12.5 mg/kg-bw
NOAEL = 250 mg/kg-diet/day
LD50>2250 mg/kg
LC50>10,000 mg/kg-diet
NOAEC = 1550 mg/kg-diet
Citrus
RQ
O.711
<0.0791
0.822
533
6.13
<0.614
O.09
0.56
Non-
cropland RQ
<3.01
<0.341
3.52
2253
26.03
<2.64
<0.374
2.363
 1 since this RQ is indiscreet, it potentially exceeds the LOC for terrestrial invertebrates (0.05)
 2exceeds the acute listed species LOC of 0.1
 3exceeds chronic, listed species LOC (1.0)
 4since this RQ is indiscreet, it potentially exceeds the acute listed species LOC of 0.1

As  described above, to assess  risks of bromacil to prey (small mammals) of larger
terrestrial-phase  CRLF,  dietary-based and dose-based exposures modeled in T-REX for a
small mammal (15g) consuming short grass are used. Acute, subacute and chronic effects
are  estimated using the most sensitive mammalian toxicity data. EECs are divided by the
toxicity value to estimate acute and chronic dietary-based RQs as well  as acute dose-
based RQs.  For all uses on citrus and non-cropland, acute RQ values exceed the acute
risk to listed species and non-listed species LOCs (RQ>0.1  and 0.5, respectively) and
chronic dose-based and  dietary-based RQ values exceed the chronic risk LOC (RQ>1.0)
for  mammals considered as potential prey species for CRLF (Table 36).

An  additional prey item of the adult 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. These are the same EECs,
toxicity values and RQs used to assess direct effects to the CRLF. For use on citrus, dose-
based RQs potentially exceed the LOC. Acute and chronic, dietary-based RQs for use on
citrus do not exceed the LOC. For use  on  non-cropland  areas, the LOC is potentially
exceeded by RQs for dose-based and dietary-based exposures (Table 36).
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              5.1.2.3. Indirect Effects to CRLF through effects to habitat (plants)
For use on citrus and non-cropland areas, RQs exceed the LOG for monocots and dicots
exposed to bromacil through runoff and drift (Table 37).

Table 37. RQ values for exposures of terrestrial plants to bromacil. RQs estimated using TerrPlant.
Plant type
Monocot1
Dicot2
Exposure
Dry Areas
(runoff and drift)
Semi-Aquatic Areas
(runoff and drift)
Spray Drift only
Dry Areas
(runoff and drift)
Semi-Aquatic Areas
(runoff and drift)
Spray Drift only
Citrus
RQ
133
1093
2.13
823
6943
143
Non-cropland
RQ
313
2623
5.13
1973
16713
333
                 :based on EC2s = 0.03 Ibs a.i./A (effects on seedling emergence)
                2based onEC25 = 0.0047 Ibs a.i./A (effects on seedling emergence)
                      3exceeds LOG (1.0) for non-listed terrestrial plants
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.

If the RQs presented in the Risk Estimation (Section 5.1) show no  indirect effects and
LOCs for the CRLF  are not exceeded for direct effects, a "no effect"  determination is
made, based on use of bromacil and bromacil lithium within the action area.  If, however,
indirect effects are anticipated and/or exposure exceeds the LOCs for direct effects, the
Agency concludes a preliminary "may affect"  determination for the  CRLF.  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 and potential community-level effects to
aquatic  plants.  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.

The criteria used to make determinations that  the effects of an action are "not likely to
adversely affect" the CRLF include the following:

   •   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"
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       occurs for even a single individual.  "Take" in this context means to harass or
       harm, defined as the following:

          o  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.

          o  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.  For example,  use of dose-response information to
       estimate the likelihood of effects can inform the evaluation of  some discountable
       effects.

    •   Adverse Nature of Effect: Effects that are wholly beneficial without any adverse
       effects are not considered adverse.
       5.2.1. Direct Effects

              5.2.1.1. Aquatic-phase

Citrus

Acute and chronic RQ values representing uses of bromacil on citrus are insufficient to
exceed  the  LOCs for direct  effects  to the CRLF in aquatic habitats.  Therefore,  the
determination for direct effects to the CRLF in aquatic habitats is "No Effect" for uses of
bromacil on citrus.

Non-cropland

For bromacil and bromacil  lithium uses on non-cropland areas, the acute risk LOG is
exceeded for direct effects to the CRLF in aquatic habitats. The chronic risk LOG is  not
exceeded for direct effects to the CRLF in  aquatic  habitats, indicating  that chronic
exposures  to the  CRLF  in aquatic  habitats   are  not of  concern.   Therefore,  the
determination is "May Affect" based on acute exposures resulting from applications of
bromacil and bromacil lithium.

In this assessment, it is assumed that modeling the highest rate possible for bromacil (2
applications of 15.4 Ibs a.i./A per year) is a conservative representation of applications of
both bromacil and bromacil lithium, the latter of which has a lower maximum application
rate of 12 Ibs a.i./A (1 application per year). Modeling the  highest application scenario
results in higher aquatic EECs. In this case, aquatic EECs resulting from the maximum
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use of bromacil are sufficient to exceed the listed species LOG for acute exposures.
However, aquatic EECs resulting from applications of bromacil lithium at its maximum
use rate  are insufficient to exceed  the listed species LOG  (Table  38).  Therefore, for
bromacil lithium, the determination for acute exposures of bromacil to the CRLF is "Not
Likely to Adversely Affect."

Table 38. RQ values for acute and chronic exposures directly to the CRLF in aquatic habitats
resulting from applications of bromacil and bromacil lithium to non-cropland areas at the maximum
uses allowed by labels.




Chemical
Bromacil
Bromacil lithium
Max single
application rate
(number of
applications/year)
(in Ibs a.i./A)
15.4 (2)
12(1)


Peak
EEC
(mg/L)
2.34
0.83



60-d EEC
(mg/L)
2.32
0.83



Acute CRLF
RQ1
0.0653
0.023



Chronic
CRLF RQ2
0.77
0.28
  'Calculated using LC50=36 mg/L.
  Calculated using NOAEC = 3 mg/L.
  3Exceeds acute, listed species LOG (0.05).

Estimates of acute exposure of CRLF to bromacil from uses in rights-of-way result in
RQs that exceed the acute risk LOG by a factor of 1.3X. An analysis of the likelihood of
individual direct mortality is conducted using the LCso of 36 mg/L and the default slope
of 4.5. For non-cropland areas, the likelihood of individual mortality is 1 in 2.17e7, which
is equivalent to a 0.00005% chance.

Based the above information, acute effects directly to aquatic-phase CRLF resulting from
bromacil applications at the maximum allowed  rate to non-cropland  areas  although
possible, are insignificant. Therefore, the determination for effects to the aquatic-phase
CRLF resulting from bromacil and bromacil lithium use on non-cropland areas is "Not
Likely to Adversely Affect."

              5.2.1.2. Terrestrial-phase

Although dietary-based RQ values are considerably lower than dose-based RQ values
(Table 35), the former do not take into account that different sized animals  consume
differing amounts of food and that depending on the forage  item, an animal  has to
consume varying amounts due to differing nutrition levels in the food item.  If dietary-
based RQ values are adjusted to  account for differential food consumption, the adjusted
RQ value would likely approximate the dose-based RQ value.

Exposure modeling with T-REX  results in some LOG exceedances for RQs representing
bromacil exposures to the terrestrial-phase CRLF. As discussed above (Section 2.10.1.1),
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.   The T-HERPS  model  was  used  to  account  for  amphibian-specific
exposures.
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In order to explore influences of amphibian-specific food intake equations on potential
dose-based and dietary-based exposures of the terrestrial-phase CRLF to bromacil, T-
HERPS was used. With  T-REX,  applications of bromacil to citrus and non-cropland
areas, results in  dietary-based exposures of 864 and 3655 ppm, respectively. Dietary-
based EECs for CRLF modeled using T-HERPS range 704-1536 ppm for citrus, and 421-
6728 ppm for non-cropland areas, depending upon the food source. With T-REX, dose-
based EECs of 984 and 4162 mg/kg-bw, were derived for citrus and non-cropland areas,
respectively. Dose-based EECs for CRLF modeled using  T-HERPS range 2.40-957
mg/kg-bw for citrus and 10.5-4194 for non-cropland areas (Table 39). Outputs from T-
HERPS are available in Appendix E.

Table 39. Dietary-based and dose-based EECs relevant to direct effects to the CARLF through
consumption of prey contaminated by bromacil. Modeling done with T-HERPS.
Food
Dietary
Based EEC
(ppm)
Dose Based
EEC
(mg/kg-bw)
1.4 g CRLF
Dose Based
EEC
(mg/kg-bw)
37 g CRLF
Dose Based
EEC
(mg/kg-bw)
238 g CRLF
Citrus
Small Insects
Large Insects
Small Herbivore mammals
Small Insectivore mammals
Small Terrestrial Phase
Amphibians
1536
704
864
96.0
1012
59.7
27.4
33.6
3.73
N/A
58.7
26.9
33.0
3.67
957
38.4
17.6
21.6
2.40
149
Non-cropland areas
Small Insects
Large Insects
Small Herbivore mammals
Small Insectivore mammals
Small Terrestrial Phase
Amphibians
6728
3084
3784
421
4433
261
120
147
16.3
N/A
257
118
145
16.1
4194
168
77.2
94.7
10.5
652
Acute dose-based and dietary-based RQs are based upon indiscreet toxicity endpoints,
where the LD50 and LCso values, (defined as  >2250 mg/kg and > 10,000  mg/kg-diet,
respectively), were not quantified. In the available LDso study for birds, no mortality was
observed in any of the treatment groups. In the LC50 study with quail, mortalities were
observed in several of the treatment groups; however, mortality in each treatment group
was  <50%.  Therefore,  acute  RQ  values are  indiscreet,  and, in  cases where  LOG
exceedances are observed,  there is only the potential for an exceedance, i.e., RQ values
are actually less than the calculated value; however, the extent to which they  are lower is
uncertain.  Because LD50  and LCso values were not  defined, likelihood of individual
mortality could not be determined for direct acute affects to the terrestrial phase CRLF.

Citrus

For citrus, the acute dose-based RQ potentially exceeds  the LOG, resulting in a "may
affect" determination for acute exposures of the CRLF to bromacil. For acute  and chronic
dietary-based exposures  resulting from bromacil use on citrus, RQs  do not exceed the
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LOCs. Therefore, dietary-based exposures  of CRLF to bromacil  are not considered in
determining risk.

Amphibian-specific  refinement of dose-based  exposure  modeling  using T-HERPS
indicates that the LOG is potentially exceeded for 37  g CRLF consuming  small
herbivorous mammals (Table 40). Since there is uncertainty associated with  this RQ,
available sublethal effects information are used to further characterize the risk to this size
of CRLF feeding on  mammals. In the  avian acute oral toxicity study (MRID 40951501),
sublethal effects (5.1% reductions in body weight gains) were observed as  low as 1350
mg/kg. Direct comparison of this value to dose-based EECs calculated by T-HERPS for
citrus (Table 39) indicates that estimated exposure concentrations are  insufficient to
reach the levels where these effects were observed, indicating that sublethal effects would
be unlikely from dose-based acute exposures.   Since  sublethal effects are unlikely to
occur, it follows that lethal effects  would also be unlikely  to  occur resulting from
applications of bromacil to citrus.

Table 40. Acute and chronic, dietary-based  RQs and dose-based RQs for direct effects to the
terrestrial-phase CRLF, based on bromacil exposures resulting from applications to citrus. RQs
calculated using T-HERPS.
Food
Small Insects
Large Insects
Small Herbivore mammals
Small Insectivore mammals
Small Terrestrial-phase
Amphibians
Dietary
Based
Acute RQ
0.09
<0.01
0.10
O.01
O.01
Dietary
Based
Chronic
RQ
0.56
0.06
0.65
0.04
0.02
Dose Based
RQ
1.4 g CRLF
0.01
O.01
N/A
N/A
N/A
Dose Based
RQ
37 g CRLF
0.01
O.01
0.431
O.03
O.01
Dose Based
RQ
238 g CRLF
0.01
O.01
0.01
O.01
O.01
 NA = not applicable
 1 since this RQ is indiscreet, it potentially exceeds the acute listed species LOG (0.1)

Based the above information, acute and chronic effects directly to terrestrial-phase CRLF
resulting from bromacil applications at the maximum allowed rates to citrus are unlikely
to occur. Therefore, the determination for effects to the terrestrial-phase CRLF resulting
from bromacil use on citrus is "Not Likely to Adversely Affect."

Non-Cropland

For  non-cropland  areas,  RQs  for  acute  dose-based  and dietary-based  exposures
potentially exceed the LOG. Also, RQs for chronic dietary-based exposures exceed the
LOG. Therefore, a "may affect" determination is made for direct effects to the CRLF
resulting from bromacil exposures from use on non-cropland areas.

Amphibian-specific refinement of exposure modeling using T-HERPS indicates that RQs
representing exposures of CRLF to bromacil  from applications  non-cropland areas still
exceed the LOG for some feeding categories and exposure types. Dietary-based RQs for
bromacil uses  exceed  the acute  and chronic risk LOCs  for  direct  effects to CRLF
consuming small insects and small herbivorous mammals. RQs for dose-based exposures
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resulting from bromacil applications to non-cropland areas potentially exceed the LOG
for 37-g CRLF consuming small herbivorous  and insectivorous mammals and 238-g
CRLF consuming small herbivorous  mammals (Table 41).

Table 41. Acute and chronic, dietary-based RQs and dose-based RQs for direct effects to the
terrestrial-phase CRLF, based on bromacil exposures resulting from bromacil applications to non-
cropland areas (max rate = 2 applications of 15.4 Ibs a.i./A). RQs calculated using T-HERPS.
Food
Small Insects
Large Insects
Small Herbivore mammals
Small Insectivore mammals
Small Terrestrial-phase
Amphibians
Dietary
Based
Acute RQ
O.381
<0.04
<0.441
0.03
0.01
Dietary
Based
Chronic
RQ
2.442
0.27
2.862
0.18
0.08
Dose Based
RQ
1.4 g CRLF
O.07
O.01
N/A
N/A
N/A
Dose Based
RQ
37 g CRLF
O.06
O.01
<1.861
0.121
0.01
Dose Based
RQ
238 g CRLF
O.04
O.01
<0.291
0.02
0.01
 NA = not applicable
 1 since this RQ is indiscreet, it potentially exceeds the acute listed species LOG (0.1)
 2exceeds chronic, listed species LOG (1.0)

Consideration of  the  lower  maximum application rate of bromacil  lithium (i.e.  1
application  of  12 Ibs  a.i./A/year) results  in acute  dose-based EECs sufficient to
potentially exceed the  LOG for 37-g and  238-g CRLF consuming small herbivorous
mammals. Acute dietary-based  EECs  are sufficient to potentially exceed the LOG for
CRLF consuming small insects and small  herbivore mammals. Chronic dietary-based
EECs  are sufficient to  exceed the LOG for CRLF  consuming small  insects and small
herbivore mammals (Table 42).

Table 42. Acute and chronic, dietary-based RQs and dose-based RQs for direct effects to the
terrestrial-phase CRLF, from bromacil lithium applications to non-cropland areas (max rate = 1
application of 12 Ibs a.i./A). RQs calculated using T-HERPS.
Food
Small Insects
Large Insects
Small Herbivore mammals
Small Insectivore mammals
Small Terrestrial-phase
Amphibians
Dietary
Based
Acute RQ
0.161
0.02
<0.191
O.01
O.01
Dietary
Based
Chronic
RQ
1.052
0.12
1.222
0.08
0.04
Dose Based
RQ
1.4 g CRLF
0.03
0.01
N/A
N/A
N/A
Dose Based
RQ
37 g CRLF
0.03
0.01
o.so1
O.05
O.01
Dose Based
RQ
238 g CRLF
0.02
0.01
<0.121
O.01
O.01
 NA = not applicable
 1 since this RQ is indiscreet, it potentially exceeds the acute listed species LOG (0.1)
 2exceeds chronic, listed species LOG (1.0)

In the avian  acute oral toxicity  study (MRID 40951501), sublethal  effects  (5.1%
reductions in body weight gains) were observed as low as 1350 mg/kg. For non-cropland
areas, direct comparison of the NOAEL of 1350 mg/kg to EECs (Table 39) indicates that
exposure levels for only one  feeding category (37 g CRLF consuming small herbivore
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mammals) is sufficient to exceed the level where sublethal effects were observed in the
available acute oral study with birds.

In the avian  subacute dietary toxicity study (MRID 00013295), mortality was observed in
treatment levels as low as 464 mg/kg-diet/day (10% mortality), while 20% mortality was
observed in treatment levels as low as 2150 mg/kg-diet/day. Direct comparison of refined
acute dietary-based EECs (from T-HERPS; Table  39) indicates that EECs for some
feeding categories (CRLF  consuming small insects  and small  herbivore mammals)
exceed the levels where 10% and 20% mortality was observed in this laboratory  study. It
should be noted that there  is uncertainty regarding  the significance of these results in
comparison to controls, where 6.8% mortality was observed.

In the  chronic toxicity studies involving  birds, the NOAEC  was  1550 mg/kg-diet/day.
This value  is used for deriving RQs in the risk estimation  of this  assessment. In this
study, the lowest level  where effects were observed  (i.e. the LOAEC) was 3100 mg/kg-
diet/day.  Direct  comparison of chronic dietary-based EECs resulting  from  bromacil
applications to the LOAEC indicate that EECs are sufficient to  exceed the level where
reproductive effects were observed in birds. Direct comparisons of chronic dietary-based
EECs resulting from  applications of bromacil lithium are insufficient to exceed the LOG
indicating that there is uncertainty associated with the chronic effects of bromacil on the
CRLF resulting from applications of bromacil lithium.

Acute effects directly to terrestrial-phase CRLF  resulting from  bromacil and  bromacil
lithium  applications  at  the maximum allowed rates to non-cropland areas cannot be
discounted. At the maximum use rate of bromacil, there is also potential for risk directly
to the terrestrial-phase CRLF based on chronic exposures.  Therefore, the determination
for effects to the  terrestrial-phase CRLF  resulting from bromacil  and bromacil lithium
uses non-cropland areas is "Likely to Adversely Affect.".

       5.2.2. Indirect Effects (through effects to prey)

As  discussed in  section 2.5.3, the diet  of tadpole CRLF  is composed primarily  of
unicellular aquatic plants and detritus.  Juvenile  CRLF consume primarily aquatic and
terrestrial invertebrates. The diet of adult CRLF  is composed of aquatic and terrestrial
invertebrates, fish, frogs and mice. These prey  groups are  considered in determining
indirect effects to the CRLF caused by direct effects to its prey.

Unicellular plants

Based  on LOG  exceedances of RQs for  algae (Table 32), applications  of bromacil to
citrus and bromacil and bromacil lithium to non-cropland areas result in potential effects
to this food source.  Therefore, a "may affect" determination is also made for indirect
effects  to the CRLF through reductions  to a  food source resulting from  bromacil
exposures from use on citrus and non-cropland areas.
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Available effects data for green algae (ECso=6.8 |ig/L; MRID 42516401) represent the
most sensitive data for unicellular aquatic plants.  Toxicity data are available for other
unicellular aquatic plants exposed to  bromacil (Table  22). Comparison of peak aquatic
EECs resulting from bromacil use on citrus is sufficient to result in RQ values that would
exceed the LOG for 3 of 4 unicellular aquatic plant species for which toxicity data exist.
Comparison of peak aquatic EECs resulting from bromacil use on non-cropland areas is
sufficient to result in RQ values that would exceed the LOG for 4 of 4 unicellular aquatic
plant species (Table 43).

Table 43. Species specific RQs for unicellular aquatic plants.
Use
Citrus
Non-cropland
Green
Algae RQ
8.21
3441
FW Diatom
RQ
8.11
3391
Marine
Diatom RQ
4.61
1931
Blue Green
Algae RQ
0.8
341
                       exceeds LOG (1.0) for non-listed aquatic plants

A source of uncertainty in the derivation of RQs is the estimation of exposure.  Peak
EECs  are  several orders  of magnitude above the highest measured concentration of
bromacil in California  surface waters (0.0075 mg/L);  however, the highest  measured
concentration of bromacil is sufficient to exceed the LOG for aquatic unicellular plants.

Based  on this information, exposures of bromacil in aquatic habitats have the potential to
affect populations and even communities of aquatic algae.

Aquatic invertebrates

Acute  and chronic RQ values representing uses of bromacil on citrus and non-cropland
areas are insufficient to exceed the LOCs for effects to invertebrates in aquatic habitats.
Even if RQs were derived using more conservative endpoints for acute toxicity available
in the  literature (48-h ECso = 65  mg  a.i./L; Foster et al. 1998), these values would not
exceed the LOG.  Therefore, aquatic invertebrates are unlikely to be directly affected due
to exposures to bromacil in aquatic habitats.

Terrestrial invertebrates

Because the LDso used in deriving RQs for terrestrial invertebrates is not quantified, RQs
for acute exposures of bromacil  to small and  large terrestrial invertebrates potentially
exceed the LOG of 0.05 for citrus and non-cropland areas  (Table 36). This results in a
"may affect" determination for indirect effects to  the CRLF due to  acute exposures of
terrestrial invertebrates to bromacil.

In the one of the available toxicity studies with honey bees,  1.2% mortality was observed
at 1209 jig a.i./g (MRID 00018842). Direct comparison of the level were 1.2% mortality
was observed with  EECs  calculated by T-REX for small and large insects exposed to
bromacil applied to citrus, the EECs are insufficient to reach the level  where  1.2%
mortality was observed in honey  bees.  Therefore, for bromacil applications to citrus,
mortality to terrestrial invertebrates is insignificant.
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For large insects,  EECs for non-cropland  areas are also below the level where 1.2%
mortality was observed in honey bees, indicating that EECs directly on the application
site resulting from  applications of bromacil to non-cropland areas are insufficient to cause
1.2%  mortality in  bees.    For  small  insects,  EECs  for  non-cropland  areas  are
approximately 3x the level where 1.2% mortality was observed in honey bees, indicating
that applications of bromacil to non-cropland areas could potentially result in mortality to
>1.2% of small sized insects. It is expected that beyond the edge of the application site,
EECs will be below the level where 1.2% mortality was observed in honey bees.The
intent of estimating  exposures and subsequent  risks to two size classes of insects is to
bound potential effects to this prey class.  There is potential for effects to some terrestrial
invertebrates (small) representing CRLF prey; however, it seems unlikely that large sized
terrestrial invertebrates will be affected  significantly by bromacil applications to non-
cropland areas, leaving terrestrial invertebrates to serve as prey to terrestrial-phase CRLF.
Based this information, indirect effects to terrestrial-phase CRLF from acute effects to
terrestrial invertebrates resulting from bromacil applications  to non-cropland areas are
insignificant.

Fish and aquatic-phase amphibians

RQ values representing direct exposures of bromacil to aquatic-phase CRLF can  also be
used to represent exposures of bromacil to  fish and frogs in aquatic habitats.  Therefore,
the conclusions made above for direct effects to the CRLF (section 5.2.1.1) also apply to
effects to fish and aquatic amphibians representing prey for the CRLF. Acute and chronic
effects  are unlikely for fish  and  aquatic  amphibians  exposed to  bromacil  after
applications to citrus.  Acute and chronic effects are insignificant for fish and  aquatic
amphibians exposed to bromacil after applications of bromacil and bromacil  lithium to
non-cropland areas.

Small terrestrial mammals

Estimates of acute  exposure of small mammals  (consuming grass)  to bromacil from uses
in citrus and non-cropland areas result in RQs that exceed the acute risk LOG by factors
of 8.2X and 35X, respectively. Estimates of bromacil exposures resulting from bromacil
lithium applications to non-cropland  areas result in RQs that exceed the acute risk LOG
by 15.4X.  Where  bromacil or bromacil  lithium is applied, exposures are sufficient to
exceed the LOG for up to 23 and 52  feet beyond the  edge of the field of citrus and non-
cropland areas, respectively (Table 18).

An analysis  of the  likelihood  of individual acute mortality for mice on the  site of
application is conducted using the LD50  of 812 mg/L and the default slope of 4.5. For
citrus, the likelihood of individual mortality is estimated as 1 in 2.9,  or 34.5%. For non-
cropland areas, the likelihood of individual mortality is approximately  1 in 1, or 100%.
As the distance from the edge of the field  increases, the exposure decreases,  and along
with that, the likelihood of individual mortality decreases.
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For chronic exposures of bromacil resulting from use on citrus, dietary-based and dose-
based RQs exceed the LOG by factors of 6.1 and 53, respectively. For chronic exposures
of bromacil resulting from  use on non-cropland areas, dietary-based and dose-based RQs
exceed the LOG by factors of 26 and 225, respectively. Estimates of bromacil exposures
resulting from bromacil lithium applications to non-cropland areas result in dietary-based
and dose-based RQs that exceed the acute risk LOG by 11.5X and  100X, respectively. If
RQs were derived using the LOAEC  (2500 mg/kg-diet/day) from the available study
involving chronic exposures of rats to bromacil, chronic RQs would still be sufficient to
exceed the LOG  for uses on citrus and  on non-cropland  areas. Where bromacil or
bromacil lithium is applied, exposures are sufficient to exceed the LOG for up to 132 and
292 feet beyond the edge of the field of citrus and non-cropland areas, respectively. As
the distance from the edge of the field increases, the exposure decreases, and along with
that, the likelihood of effects decreases.

Therefore, on the site of applications of bromacil and bromacil lithium as well as some
distance beyond the edge of the field, there is potential for effects to small mammals.

Small terrestrial-phase amphibians

An additional prey item of the adult  CRLF is other species of terrestrial-phase 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.  For use on
citrus,  dose-based RQs potentially exceed the LOG. Acute  and chronic, dietary-based
RQs for use on citrus do not exceed the LOG. For use on non-cropland areas, the LOG is
potentially exceeded by RQs for dose-based and dietary-based exposures (Table  36).
Therefore, for bromacil use on citrus and bromacil and bromacil  use on non-cropland
areas, there is potential for effects to  terrestrial-phase amphibians which are potential
prey to CRLF. Where bromacil or bromacil lithium is applied, exposures are sufficient to
exceed the LOG for up  to  16 and 36  feet beyond the edge of the field of citrus and non-
cropland areas, respectively (Table 18).

In order to explore influences of amphibian-specific food intake equations on potential
dose-based and dietary-based  exposures of amphibians (prey  of CRLF) to bromacil, T-
HERPS is used. The Pacific tree frog is used to represent amphibian prey species.  The
weight of the animal is assumed to be 2.3 g, and its diet is assumed to be composed of
small and large insects.   A range  of  RQs is  presented in  Table 44  for  each  use
corresponding to EECs  resulting from bromacil exposures to frogs  consuming large (low
RQ) and small insects (high RQ).

For Pacific tree frogs consuming small  and large insects, acute dietary-based exposures
as well as dose based  exposures of bromacil resulting from applications to citrus  are
insufficient to  exceed  the acute or chronic LOCs  (Table  44).  Therefore, acute  and
chronic effects  are unlikely for terrestrial-phase amphibians exposed  to bromacil after
applications to citrus.
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Table 44. RQ values for exposures of terrestrial frogs (prey of CRLF) to bromacil. RQs estimated
using T-HERPS.
Exposure
Dose-acute
Dietary-acute
Dietary-chronic
Toxicity Value
LD50>2250 mg/kg
LC50>10,000 mg/kg-diet
NOAEC = 1550 mg/kg-diet
Citrus
RQ
<0.01
0.01-0.09
0.06-0.56
Non-cropland RQs
Bromacil
O.01-0.06
0.04-0.381
0.27-2.442
Bromacil
lithium
O.01-0.02
0.02-0.161
0.12-1.051
  'Potentially exceeds acute, listed species LOG (0.1).
  2exceeds chronic, listed species LOG (1.0).

For applications of bromacil  and bromacil lithium  to  non-cropland  areas, the acute,
dietary-based RQ for Pacific tree frogs potentially exceeds the listed species LOG (Table
44). In the  sub-acute dietary study used to define acute dietary-based RQs for frogs, less
than 50% mortality was observed at bromacil exposures of 10,000 mg/kg-diet (MRID
00013295). Direct  comparison of bromacil EECs for the Pacific tree frog resulting from
applications to non-cropland  areas indicates that EECs  are below the level where less
than 50% mortality was observed in this laboratory study. In this study, 20% mortality
was observed in treatment levels as low as  2150 mg/kg-diet/day. Direct comparisons of
acute dietary-based EECs for the Pacific tree frog indicate that EECs for frogs consuming
large invertebrates  are insufficient to exceed this level while EECs for small invertebrates
exceed this level where 20% mortality was observed.

For applications of bromacil and bromacil lithium to non-cropland areas, chronic dietary-
based RQs exceed the LOG for frogs consuming small  insects but not for  those
consuming large insects (Table 44).  Since frogs would be expected  to consume both
small and  large insects,  it seems likely that the  actual EEC  should fall somewhere
between the extreme EECs representing diets composed only of small insects and diets
composed only of large insects.

Summary of indirect effects to the CRLF based on effects to prey

Based  on the  above information, there is potential for applications of bromacil or
bromacil lithium to citrus and non-cropland areas to cause effects to aquatic algae.  Since
CRLF  rely upon aquatic  algae as a food  source  during the tadpole stage, decreased
availability of  algae biomass  could indirectly affect the CRLF during  this life stage.
Effects to aquatic  and terrestrial invertebrates, which compose  the diet  of the juvenile
CRLF, are not expected from bromacil or bromacil lithium applications to citrus or to
non-cropland areas. Because the adult CRLF is an opportunistic feeder, it will consume
available prey.  Potential prey includes aquatic and  terrestrial invertebrates, fish, aquatic
frogs, terrestrial frogs and mice. Although there is potential for effects to mice  and near
the site of  application, indirect effects to the CRLF based  on decreased availability of
prey are not expected. It is expected that there will be sufficient prey to maintain the adult
CRLF.

For applications of bromacil  or bromacil lithium to citrus  and  non-cropland areas, the
determination for indirect effects to the tadpole-phase of the CRLF, based  on decreased
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availability of prey, is "Likely to Adversely Affect."   For the juvenile and adult life
stages of the CRLF, the determination is "Not Likely to Adversely Affect."

       5.2.3. Indirect Effects (through effects to habitat)

Aquatic habitat

The aquatic habitat of the CRLF is composed of unicellular and vascular aquatic plants,
as well as riparian vegetation. Citrus and non-cropland RQs for all three groups exceed
the LOG (Tables 34 and 37), resulting in a "may affect" determination for indirect
effects to the CRLF based on effects to its aquatic habitat.

Available effects data  for green algae (ECso=6.8 ng/L; MRID 42516401) represent the
most  sensitive data for unicellular aquatic plants.  Comparison of peak aquatic EECs
resulting from bromacil use on citrus is sufficient to result in RQ values that would
exceed the LOG for 3 of 4 unicellular aquatic plant species for which toxicity data exist.
Comparison of peak aquatic EECs resulting from bromacil use on non-cropland areas is
sufficient to result in RQ values that would exceed the LOG for 4 of 4 unicellular aquatic
plant  species. Therefore, EECs are at levels  sufficient to decrease populations of algae by
>50% in multiple species  of algae.  This indicates  concern  for alteration  of  algal
communities by  decreasing overall algal biomass and altering dominant species.

EECs  are  also  sufficient   to  exceed  concentrations  where  frond  numbers  were
significantly  decreased  in   duckweed.  This  indicates  that  at  estimated  exposure
concentrations, bromacil has the potential  to decrease populations of vascular  aquatic
plants.

Concentrations of bromacil  reaching riparian vegetation through runoff and spray drift
are at levels where reduced dry weight was observed in monocots  and  dicots.  This
indicates  that exposures  of bromacil  could result  in  reduced  biomass  in  riparian
vegetation.

Loss of aquatic and riparian vegetation could result in alteration of physical and chemical
characteristics of the aquatic habitat of the CRLF. These potentially include: alteration of
the morphology  of channels and ponds, alterations of geometry  of channels and ponds,
increases in sediment depositions, loss of shelter for CRLF, alteration in water chemistry
(including temperature, turbidity, and oxygen content). These  changes could potentially
alter the conditions necessary  for normal  growth and viability of juvenile and  adult
CRLFs and their food source.

Therefore,  the  determinations for indirect effects to the CRLF caused by effects to
aquatic and riparian plants resulting from bromacil and bromacil lithium uses  on citrus
and non-cropland areas are "Likely to Adversely Affect."
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Terrestrial habitat

The terrestrial habitat of the CRLF is composed of vascular plants, including monocots
and dicots. Citrus and non-cropland RQs for these plants exceed the LOG (Table 37),
resulting in a "may affect" determination for indirect effects to the CRLF based on effects
to its terrestrial habitat.

Exposures to plants inhabiting terrestrial habitats could come from both runoff and spray
drift from the treatment site. EECs calculated by TerrPlant indicate that each exposure
pathway by itself is sufficient to exceed the LOG for non-listed plants, including both
monocots and dicots. Refined modeling of bromacil exposures of plants through spray
drift indicate that exposures exceed the EC25s for monocots and dicots up to 437 and
4026 feet, respectively, from the edge of citrus fields where bromacil is applied.  Also, for
bromacil and bromacil lithium applications to non-cropland areas, spray drift exposures
exceed the EC25S for monocots and dicots up to 810 and 5909 feet, respectively,  from the
edge of the treatment area (Table  18).

As discussed in section 4.3, there are a number of reported incidents associated with
bromacil involving damage to terrestrial plants. These incidents reported observed effects
to individual plants, including trees,  effects to lawns, and effects to crops covering areas
greater than  100 acres. In some cases, other herbicides where applied along with bromacil
(e.g. diuron, atrazine, metolachlor). Reports indicated that bromacil exposures occurred
through direct treatment of areas, spray drift, runoff and carryover from one season to the
next.

Loss of vegetation in the terrestrial habitat of the CRLF could impact the ability  of that
habitat to support the food source  of the CRLF. Loss of this vegetation could also reduce
available shelter for CRLF.

Therefore, the  determinations for indirect effects  to the CRLF caused by effects to
terrestrial plants resulting from bromacil and bromacil lithium uses on citrus  and non-
cropland areas are "Likely to Adversely Affect."

       5.2.4. Primary Constituent  Elements of Designated Critical Habitat

              5.2.4.1. 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:

   •   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.
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   •   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)

Due  to RQ exceedances for several  species of algae, as  well as for aquatic vascular
plants, bromacil use on citrus and bromacil and bromacil  lithium use on non-cropland
areas use results in a determination of "habitat modification."

The  remaining  aquatic-phase  PCE  is "alteration  of other chemical  characteristics
necessary for normal  growth and viability of CRLFs and their food source." As stated
previously, RQs for algae, which represent a food source for larval  CRLF (tadpoles),
exceed  the LOG.  Therefore,  the determination for this endpoint  is  also  "habitat
modification."

              5.2.4.2. Terrestrial-Phase (upland habitat and dispersal habitat)

Similar to the aquatic-phase  PCEs,  three  of the  four  assessment endpoints for the
terrestrial-phase PCEs of designated critical habitat for the CRLF are related to potential
effects to aquatic and/or 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
   •   Alteration of chemical  characteristics necessary for normal growth and viability
       of juvenile and adult CRLFs and their food source.

Due  to RQ  exceedances  for  exposures  of plants  inhabiting dry  areas  to  bromacil
contained in runoff and in drift, bromacil use on citrus and bromacil and bromacil lithium
use on non-cropland areas use results in a determination of "habitat modification."

The remaining terrestrial-phase PCE is "reduction and/or modification of food sources
for terrestrial  phase juveniles and adults."   Acute and chronic RQs  for mice,  which
represent a food source for terrestrial phase CRLF, exceed the LOG for bromacil uses on
citrus and bromacil and bromacil lithium  uses  on non-cropland areas.  Therefore, the
determination for this  endpoint is "habitat modification."
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       5.2.5. Action Area

              5.2.5.1. Areas indirectly affected by the federal action

The initial action area for bromacil was previously discussed in Section 2.7 and depicted
in Figures 4 and 5 of the problem formulation.  In order to determine the extent of the
action area in lotic (flowing) aquatic habitats, the greatest ratios of the RQ to the LOG for
any endpoint for aquatic organisms for each use is used  to  determine the distance
downstream for concentrations to be diluted below levels that would be of concern (i.e.
result in RQs above the LOG). For this  assessment, this applies to RQs for algae. The
action area is determined based on risks to all listed species based on bromacil exposures
resulting from applications of bromacil  or bromacil lithium. Therefore, RQs for  listed
unicellular aquatic species are used, which are derived by dividing the peak aquatic EEC
by the NOAEC for unicellular aquatic species (<1.1 |ig a.i./L; MRID 42516401).  Also,
the LOG of 1.0 is used. The final RQ/LOC ratios are: 51 for bromacil use on citrus, and
2127  for bromacil  and bromacil lithium use on non-cropland  areas. The total stream
kilometers within the action area that are at levels of concern are defined in Table 45.

Table 45. Quantitative results of spatial analysis of lotic aquatic action area relevant to bromacil.
Measure
Total Streams in CA
Streams within initial area of concern
Downstream distance added
Streams in aquatic action area
Distance (km)
Citrus Areas
332,962
17,283
2,019
19,302
Non-
cropland
Areas
332,962
87,867
14,655
102,522
When  considering the terrestrial habitats of the CRLF, spray drift from use sites onto
non-target areas could potentially result in exposures of the CRLF, its prey and its habitat
to bromacil. Therefore, it is necessary to estimate the distance from the application site
where  spray drift exposures do not result in LOG exceedances for organisms within the
terrestrial habitat.  To account for this, first, the bromacil application rate which does not
result in an LOG exceedance is calculated for each terrestrial taxa of concern (Table 18).
The farthest distance where no LOG  is  exceeded applies to non-listed species of dicots
(terrestrial plants). As mentioned  above, the action area is determined based on risks to
all listed species based on bromacil exposures resulting from applications of bromacil or
bromacil lithium. Since effects thresholds for listed terrestrial plants are defined by the
NOAEC of available seedling emergence and vegetative vigor data, the lowest NOAEC
from terrestrial dicots (0.006  Ibs a.i./A; MRID 44488307) is  used to determine the
farthest distance from the edge of the target area where there  are no LOG exceedances for
listed species.  AgDISP was then used  to determine the distance  required to reach the
NOAEC value. For bromacil use  on citrus, this  distance is 4167 feet. For bromacil and
bromacil lithium use on non-cropland  areas, this value is 5315 feet.
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To understand the area indirectly affected by the federal action due to spray drift from
application  areas, the citrus (Figure 4) and non-cropland (Figure  5) landcovers are
considered as potential application areas. These areas are "buffered"  using ArcGIS  9.2.
In this  process, the original landcover is  modified by  expanding the  border of each
polygon representing  a  field out to a designated distance, which in this case,  is the
distance estimated where bromacil  in  spray  drift does  not  exceed any  LOCs. This
effectively expands the action  area relevant to terrestrial habitats so that it includes the
area directly affected by  the federal action, and the area indirectly affected by the federal
action.

              5.2.5.2. Final action area

In order to define the final action areas relevant to uses of bromacil and bromacil lithium
on citrus and non-cropland areas, it  is necessary to combine areas directly affected, as
well as aquatic and  terrestrial  habitats indirectly affected by the federal action. This is
done separately  for citrus  and  non-cropland  uses  using ArcGIS  9.2.   Landcovers
representing areas directly affected by bromacil and bromacil lithium applications are
overlapped with indirectly affected aquatic habitats (determined by down stream dilution
modeling)  and with indirectly affected terrestrial habitats (determined by spray drift
modeling).  It is assumed that lentic (standing water) aquatic habitats  (e.g.  ponds,  pools,
marshes) overlapping with the  terrestrial areas are also indirectly affected by the federal
action. The result is a final action area for bromacil uses on citrus (Figure 10) and a final
action area for bromacil and bromacil lithium uses on non-cropland areas (Figure 11).
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                                                                                -L
                                  -v.
                                   fVN\   '
                                  $   *f-
             Legend
                   County Boundary

                   Terrestrial and lentic action area

                   Lotic action area
            90    45     0
                                     90 Miles
   Compiled from California County boundaries (ESRI, 2002),
   USDA National Agriculture Statistical Service (NASS.2002)
   Gap Analysis Program Orchard/Vineyard Landcover (GAP)
   National Land Cover Database (NLCD) (MRLC.2001)
Map created by U.S. Environmental Protection Agency,
Office of Pesticides Programs, Environmental Fate and
Effects Div ision. April! 1, 2007.
Projection: Albers Equal Area Conic USGS,
North American Datum of 19S3 (NAD 1983)
Figure 10. Final action area for crops described by the orchard/vineyard landcover which
corresponds to potential bromacil use on citrus. This map represents the area potentially directly and
indirectly affected by the federal action.
                                                   98

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             Legend
                                                                               _L
                   County Boundary

                   Terresrial and lentic action area

                   Lotic action area
            90    45     0
                                     90 Miles
   Compiled from California County boundaries (ESRI, 2002),
   USDA National Agriculture Statistical Service (NASS.2002)
   Gap Analysis Program Orchard/Vineyard Landcover (GAP)
   National Land Cover Database (NLCD) (MRLC.2001)
Map created by U.S. Environmental Protection Agency,
Office of Pesticides Programs, Environmental Fate and
Effects Div ision. April! 1, 2007.
Projection: Albers Equal Area Conic USGS,
North American Datum of 19S3 (NAD 1983)
Figure 11. Final action area for crops described by right-of-way landcover which corresponds to
potential bromacil and bromacil lithium use sites on non-cropland areas. This map represents the
area potentially directly and indirectly affected by the federal action.
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              5.2.5.3. Overlap between CRLF habitat and final action area

In order to confirm that uses of bromacil and bromacil 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 final action areas for citrus and non-cropland
uses overlap with CRLF habitats. Spatial  analysis using ArcGIS 9.2 indicates that lotic
aquatic habitats within  the  CRLF core areas and critical habitats potentially  contain
concentrations of bromacil  sufficient to  result in RQ values that exceed LOCs. In
addition, terrestrial habitats  (and potentially lentic aquatic habitats) of the  final action
areas overlap with the core areas, critical habitat and available occurrence data for CRLF
(Tables 46-47).  Thus, uses of bromacil use  on citrus  and bromacil and bromacil  lithium
use on non-cropland areas could result in exposures of bromacil to CRLF in  aquatic and
terrestrial habitats. Additional analysis related to  the intersection of the bromacil and
bromacil lithium action areas and CRLF habitat is described in Appendix H.
Table 46. Overlap between CRLF habitat (core areas and critical habitat) and citrus action area by
recovery unit (RU#).
Measure
CRLF habitat (km2)*
Overlapping area of CRLF
habitat and terrestrial/lentic
aquatic action area (km2)
% CRLF habitat overlapping
with terrestrial/lentic aquatic
Action Area
# Occurrences overlapping
with terrestrial/lentic aquatic
action area
RU1
3654
7
0%
2
RU2
2742
14
1%
0
RU3
1323
2
0%
0
RU4
3279
50
2%
15
RU5
3650
27
1%
1
RU6
5306
159
3%
3
RU7
4917
435
9%
10
RU8
3326
497
15%
0
Total
28,197
1191
4%
31
                     *Area occupied by core areas and/or critical habitat.

Table 47. Overlap between CRLF habitat (core areas and critical habitat) and non-cropland action
area by recovery unit (RU#).
Measure
CRLF habitat (km2)*
Overlapping area of CRLF
habitat and terrestrial/lentic
aquatic action area (km2)
% CRLF habitat overlapping
with terrestrial/lentic aquatic
Action Area
# Occurrences overlapping
with terrestrial/lentic aquatic
action area
RU1
3654
1990
54%
6
RU2
2742
1220
44%
1
RU3
1323
768
58%
45
RU4
3279
1632
50%
191
RU5
3650
1661
46%
174
RU6
5306
1777
33%
63
RU7
4917
2069
42%
73
RU8
3326
1643
49%
21
Total
28,197
12,760
45%
574
                      *Area occupied by core areas and/or critical habitat.
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       5.2.6. Description of Assumptions, Limitations, Uncertainties, Strengths and
       Data Gaps

              5.2.6.1. Exposure Assessment

Aquatic habitat

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.

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. As previously  discussed in
Section 2 and in  Attachment 1, 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 2004a).

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 a
farmer's 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
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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.

There is uncertainty in  the PRZM/EXAMS application timing relative to rainfall/runoff
events.  Label instructions indicate that applications of bromacil can be made any time
during the year. Consideration of the meteorological data associated with the California
PRZM scenarios indicates that the largest rainfall events occur in January. In general, the
greater amount of rainfall in a single event, the greater the EEC in the receiving aquatic
habitat. In order to select an application date resulting in a conservative estimate of
exposure of aquatic habitats to bromacil, an application  date of January 25 was chosen.
Pesticide use data associated with bromacil (CPUR 2007)  indicates that past applications
of bromacil have been made throughout the year. Applications made at times where there
is less rainfall could potentially result in less runoff and  with that, lower concentrations of
bromacil in aquatic habitats.

A  source of uncertainty in the  derivation of RQs is the estimation of exposure.  The peak
EEC for bromacil  in aquatic environments 2.34 mg/L  based on modeling for  rights-of-
way. As discussed above (section 3.1.1), concentrations of bromacil have  been detected
in  non-target monitoring at a frequency of approximately 7% in California surface waters
at  levels over 500 times below  these estimated concentrations (the maximum detected
concentration was  0.0075 mg/L). Because the results  of the monitoring data are based
upon non-targeted monitoring, it is  uncertain of whether or not available data represent
high-end acute  exposure concentrations in California surface waters.

There is uncertainty  in this assessment associated with  the environmental fate data gaps.
Most significantly, there is some uncertainty in the EECs due to an assumption made in
the aquatic exposure modeling with regard to the degradation of bromacil in anaerobic
environments.   While  it  is  evident  that  the compound  degrades  in  anaerobic
soil/sediment, an accurate half-life value was not available, and the reported half-life (39
days) in the submitted study was not considered to be valid. In lieu of other data, the
anaerobic half-life for  bromacil using as  an input in the Tier II  modeling is 0 days (i.e.,
stable). While the use of the "0 days" as the input value would increase the EECs relative
to  using a value that  more accurately depicts the more rapid degradation rate which could
be expected in  the environment,  it is not clear whether this would result in significantly
different risk conclusions. In  a laboratory study reported in the literature, bromacil was
persistent in a  saturated sandy loam soil, with an observed half-life of 144 to 198 days
(Wolf, 1974).   Also, in the environment, bromacil would more likely be associated with
the water column than with  sediment  since  it does  not  have a tendency to  sorb to
soil/sediment particles.
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There  is no evidence of bromacil  degradation  in  aquatic  environments.   As  such,
bromacil was assumed stable in the  ecological pond used to estimate aquatic exposure
concentrations.  Since the ecological pond (used in our modeling) has no outlet, there was
a modeled accumulation of bromacil  in the pond throughout the 30 year simulations.  In
the case of persistent compounds,  a l-in-10 year  EEC  does not reflect  varying
meteorological conditions that are expected once every ten years,  since the yearly peaks
are not independent but are actually correlated to the previous year's peak concentration.
This results  in acute and chronic exposure  concentrations that are very similar (i.e, < 2%
difference between peak and 90-day average EECs).    Based on this, EECs used for
deriving RQs for aquatic organisms are potentially an  overestimate of exposures in the
aquatic habitats that do not accumulate bromacil.

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.

As discussed in the Use Characterization (section 2.4.4), uses of bromacil and bromacil
lithium on non-cropland areas apply to  a wide  variety of  areas, including: airports,
parking lots, industrial  areas,  rights-of-way  (for  railroads,  highways, pipeline   and
utilities), storage  areas, lumberyards, tank farms,  under asphalt and  concrete pavement
and fence rows.  In this assessment, aquatic EECs were derived using rights-of-way to
conceptualize the land area where these herbicides are applied. Given the difference in
surface characteristics, use of one of these  other types of non-cropland areas for defining
the conceptual model of the use area could potentially result in different estimates of
exposure. Since historical data for bromacil supports the idea that rights-of-way represent
the major non-cropland use of bromacil in California, it was determined that the rights-
of-way conceptual approach  was suitably representative of bromacil exposures in aquatic
habitats resulting from applications to non-cropland areas.

Right-of-way areas were represented by assuming that 50%  of the surface of the
watershed is impervious, while  50% is pervious. This is generally representative  of a
highway or road right-of-way, where bromacil is expected to be applied to the shoulder
area of the roadway. In this case, it is assumed that runoff from the roadway and shoulder
would  be transported  directly into the water body of concern (perhaps through drainage
ditches emptying into the water  body). Given the diversity  of types of rights-of-way to
which  bromacil and bromacil  lithium could be applied, it  is expected that the relative
percentages  of impervious and pervious surfaces varies greatly. In  deriving aquatic EECs
using this approach, increase  in the proportion of impervious  surface of a  watershed,
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results in a  decrease in EEC.  EECs included in this risk assessment result in an LOG
exceedance for direct acute effects to the aquatic-phase CRLF. If the right-of-way surface
were modeled as being composed of 60% impervious and 40% pervious, there would be
no LOG exceedance. Using a conceptual approach assuming that 100% of a right-of-way
surface is composed of pervious surface is relevant to utility rights-of-way which would
be expected to have  little impervious surface; however, it is unlikely that the  entire
watershed of a water body would be composed of this right-of-way.  It would be more
likely that the right-of-way would  cut through a watershed,  leaving only part of the
watershed treated  with bromacil or bromacil  lithium.  The use  of a PRZM scenario
assumes  that the entire watershed of an area is treated  with the pesticide  of concern.
Therefore, it is assumed that highway and road  rights-of-way would result in higher end
estimates of exposure due to applications of  bromacil  and bromacil lithium to  non-
cropland areas.

In this assessment, it is assumed that applications of bromacil  and bromacil to  non-
cropland areas are  made by ground  methods. The  label with the highest application rate
(2 applications per year of 15.4 Ibs a.i./A) prohibits aerial  applications (registration
10088-68). However, other labels exist which allow for applications of bromacil at lower
rates.   Applications by  aerial  methods result in greater  spray drift when compared to
those  made by ground methods. When compared  to the spray drift exposure estimation
included in this assessment, there is potential for greater exposures of bromacil resulting
from aerial applications of lower application rates.

Model runs are conducted without irrigation. Given that it is unlikely that rights-of-ways
and impervious surfaces will be irrigated, this is a reasonable approach. Although there is
potential for citrus orchards to be irrigated, this is not captured in the current modeling
approach due to limitations of PRZM.

Unlike spray  drift,  tools are currently not  available to  evaluate  the  effectiveness of a
vegetative setback on runoff and loadings.   The effectiveness of vegetative setbacks is
highly dependent  on the  condition  of the  vegetative  strip.   For  example, a well-
established, healthy vegetative setback can be a very effective means of reducing runoff
and erosion  from agricultural fields. Alternatively, a setback of poor vegetative quality
or a setback that is channelized can  be ineffective at reducing loadings. Until such time
as a  quantitative  method  to  estimate the  effect of vegetative setbacks  on  various
conditions on  pesticide loadings becomes available, the aquatic exposure predictions are
likely  to  overestimate  exposure   where  healthy  vegetative  setbacks  exist   and
underestimate exposure where  poorly developed, channelized, or bare setbacks exist.

Terrestrial habitat

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
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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 this baseline terrestrial 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.

Mixtures

This assessment considers only the single  active  ingredients of bromacil  or  bromacil
lithium. However, the assessed species and its environments may be exposed to multiple
pesticides simultaneously. Interactions of other toxic agents with bromacil could result in
additive  effects, synergistic effects  or  antagonistic effects. Evaluation  of  pesticide
mixtures is beyond the scope of this assessment because of the myriad factors that cannot
be  quantified based on the available data.  Those factors include  identification of other
possible co-contaminants and their concentrations, differences in the pattern  and duration
of exposure among contaminants, and the differential effects of other physical/chemical
characteristics of  the receiving waters (e.g.  organic matter  present in sediment and
suspended  water).  Evaluation  of factors that could influence additivity/synergism is
beyond the scope of this assessment and is beyond the capabilities of the available data to
allow  for an evaluation.  However, it is acknowledged that  not  considering  mixtures
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could over- or under-estimate risks  depending on the type of interaction and  factors
discussed above.

                     5.2.6.2. Effects Assessment

As previously discussed,  direct effects to aquatic-phase CRLF are based on freshwater
fish data, which are used  as a surrogate for aquatic-phase amphibians. Toxicity data for
terrestrial-phase amphibians are not available for use in this assessment. Therefore, avian
toxicity data are used as  a surrogate for terrestrial-phase CRLF.   There is uncertainty
regarding the relative sensitivity of amphibians and their surrogates to bromacil.  If the
selected  surrogate species are substantially more or less  sensitive than the CRLF, then
risk would be over or under estimated, respectively. In addition, given the small data set
for freshwater fish species (3 acute toxicity values), the potential range of sensitivities of
fish (and thus, aquatic amphibians) to bromacil.

For an acute risk assessment, 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 assessment is exercised on a
case-by-case basis  and only after careful consideration  of the nature of the sublethal
effect measured and the  extent and quality of available  data to support establishing a
plausible  relationship between the  measure  of effect  (sublethal  endpoint) and the
assessment endpoints.

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 California Red Legged Frog.

                     5.2.6.3. Action Area

An example of an important simplifying assumption that may require future refinement is
the assumption  of uniform  runoff characteristics throughout  a landscape.   It is well
documented that runoff  characteristics are  highly non-uniform  and  anisotropic, and
become increasingly so as the area under consideration becomes larger. The assumption
made for estimating the aquatic Action Area (based on predicted in-stream dilution) was
that the entire landscape exhibited  runoff properties identical to those commonly found in
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agricultural  lands in this region.  However,  considering the vastly different runoff
characteristics of: a) undeveloped (especially  forested)  areas, which  exhibit the  least
amount of  surface  runoff but  the  greatest  amount  of  groundwater  recharge;  b)
suburban/residential   areas,   which   are   dominated  by  the   relationship  between
impermeable surfaces (roads, lots) and  grassed/other areas (lawns) plus local drainage
management;  c)  urban areas,  that are dominated  by  managed storm  drainage  and
impermeable surfaces; and d) agricultural areas  dominated by Hortonian and focused
runoff (especially with  row  crops),  a refined  assessment  should incorporate these
differences for modeled stream flow generation.  As the  zone around the immediate
(application) target area expands,  there will be greater variability in the landscape; in the
context of a risk assessment, the runoff  potential that is assumed for the expanding area
will be a crucial variable (since dilution  at the outflow point is determined by the size of
the expanding area).  Thus, it important to know at least some approximate estimate of
types of land use within that region.  Runoff from forested areas ranges from 45  -
2,700% less than from agricultural areas; in most studies, runoff was 2.5 to 7 times higher
in agricultural areas  (e.g., Okisaka et  al., 1997;  Karvonen et al., 1999;  McDonald et al.,
2002;  Phuong and  van Dam  2002).   Differences  in  runoff potential  between
urban/suburban areas and agricultural  areas are generally less than between agricultural
and  forested areas.   In terms of likely runoff potential  (other variables -  such as
topography and rainfall - being equal), the relationship  is generally as follows (going
from lowest to highest runoff potential):
Three-tiered forest < agroforestry < suburban < row-crop agriculture < urban.

There are, however,  other uncertainties that should serve  to counteract  the effects of the
aforementioned issue.   For example, the  dilution model considers that  100% of the
agricultural  area  has the chemical applied,  which  is almost certainly  a gross over-
estimation.  Thus, there will be assumed chemical contributions from agricultural areas
that will  actually  be contributing only runoff water (dilutant); so  some contributions to
total  contaminant  load will really  serve  to  lessen  rather than   increase  aquatic
concentrations. In light of these  (and other)  confounding factors, Agency believes that
this model gives us the best available estimates under  current circumstances.

                     5.2.6.4. Use Data

County-level usage  data were  obtained  from California's Department  of  Pesticide
Regulation Pesticide Use Reporting (CDPR PUR) database.  Four years of data (2002 -
2005) were included in this analysis because statistical methodology for identifying
outliers, in terms  of area treated and  pounds  applied, was provided by CDPR for these
years only. No methodology for removing outliers was provided by CDPR for 2001 and
earlier pesticide data; therefore, this information was not included 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  use data, there may be
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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.

                     5.2.6.5. General Uncertainties

When  evaluating the significance of this risk assessment's  direct/indirect and adverse
habitat  modification 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
       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.
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       5.2.7. Addressing the Risk Hypotheses

In order to conclude this risk assessment, it is necessary to address the risk hypotheses
defined in section 2.9.1.  Based on the conclusions  of this assessment,  none of the
hypotheses can be rejected, meaning that the stated hypotheses represent concerns in
terms of effects of bromacil on the CRLF.
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6. Conclusions

Based  on estimated environmental concentrations for the  currently registered uses of
bromacil or bromacil lithium, RQ  values are above the Agency's LOG for direct acute
effects on the CRLF resulting from applications to citrus and non-cropland areas; this
represents a "may affect" determination.  RQs for uses on citrus and non-cropland areas
exceed the LOG for exposures to aquatic unicellular plants. Therefore, there is a potential
to indirectly affect larval (tadpole)  CRLF due to effects to the algae forage base in
aquatic habitats. The effects determination for indirect effects to the CRLF due to effects
to its prey base is "may affect." When considering  the prey of larger CRLF in terrestrial
habitats (e.g. frogs, fish and small mammals), RQs for some of these taxa also exceed the
LOG for acute and chronic exposures, resulting in a "may affect"  determination.  RQ
values for plants in  aquatic and terrestrial habitats exceed the LOG; therefore, indirect
effects to the CRLF through effects on  aquatic and terrestrial habitats result in a "may
affect" determination.

Refinement of all "may affect" determinations from bromacil use on citrus results in a
"NLAA"  determination for direct effects to the  CRLF, a  "LAA" determination for
indirect effects to the CRLF based  on effects to its prey, specifically algae, and a "LAA"
determination for indirect effects to the CRLF based on effects to aquatic and terrestrial
habitat (Table 1).  Consideration of CRLF critical habitat indicates a determination of
"habitat modification" for aquatic and terrestrial habitats based on bromacil use on citrus.
The overall CRLF effects determination for bromacil use on citrus is "LAA."

Refinement of all "may affect" determinations from bromacil and bromacil lithium use
on non-cropland areas result in a "LAA" determination for direct effects to the CRLF, a
"LAA" determination  for indirect  effects to the  CRLF based on effects  to  its prey,
specifically  algae, and a "LAA" determination for indirect effects to the CRLF based on
effects to aquatic and terrestrial habitat (Table 2). Consideration of CRLF critical habitat
indicates a  determination of "habitat modification"  for aquatic  and terrestrial  habitats
based on non-cropland uses of bromacil and bromacil lithium. The overall CRLF effects
determination for bromacil  and bromacil lithium  use on non-cropland  areas is
"LAA."

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.
Attachment 2, which includes information on the baseline status and cumulative effects
for the CRLF, can be used during this consultation to provide background information on
past US Fish and Wildlife Services  biological opinions associated with the CRLF.

When  evaluating the significance  of this risk assessment's  direct/indirect and habitat
modification 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
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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
              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.
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7. References

Altig, R. and R.W. McDiarmid. 1999. Body Plan: Development and Morphology. In
       R.W. McDiarmid and R. Altig (Eds.), Tadpoles: The Biology of Anuran
       Larvae.University of Chicago Press, Chicago, pp. 24-51.

Alvarez, J.  2000. Letter to the U.S. Fish and Wildlife Service providing comments on
       the Draft California Red-legged Frog Recovery Plan.

Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. 1969. Effect of pesticides on
       apiculture: Project No. 1499. Research report CR-7501. Unpublished study
       received May 8, 1971 under IF 1174; prepared by University of California-
       Riverside, Department of Entomology. Submitted by Ciba Agrochemical Co.,
       Summit, NJ. MRID 00018842

CDPR. 2007.  Surface Water  Database. California Environmental Protection  Agency,
       Department    of    Pesticide    Regulation.    Available     online     at:
       http://www.cdpr.ca.gov/docs/sw/surfcont.htm. (accessed 5/10/2007)

CDPR. 2007. a. Pesticide Use Reporting. California Environmental Protection  Agency,
       Department    of    Pesticide    Regulation.    Available     online     at:
       http://www.cdpr.ca.gov/docs/sw/surfcont.htm. (accessed 5/31/2007)

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.

Das, Y.T.  1988a. Hydrolysis of [2-14C]Bromacil in aqueous solutions buffered at pH 5,
       7, and 9. MRID:  40951505.

Das, Y.T.  1988b. Photodegradation of [2-14C]Bromacil in aqueous solutions buffered at
       pH5, 7, and 9.  MRID: 40951507.

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