BOX 2-1 Generic Outline for Reporting Ecological Risk-Assessment Results for Listed Species or Their Critical Habitats

1.   PROBLEM FORMULATION

1.1.  Background

1.1.1. Defining the Regulatory Action

1.1.2. Nature of the Pesticide

1.1.3. Pesticide-Use Characterization

1.1.4. Natural History of Listed Species

1.1.5. Designated Critical Habitats

1.2.  Action Area (based on use and natural history)

1.3.  Assessment End Points

1.3.1. Individuals

1.3.2. Populations

1.3.3. Critical Habitats

1.4.  Conceptual Model

1.4.1. Risk Questions or Hypotheses

1.4.2. Graphical Representation

1.5.  Analysis Plan

1.5.1. Measures (exposure, effect, and characteristics)

1.5.2. Approach to Risk Estimation

2.   EXPOSURE ANALYSIS

2.1.  Label Application Rates and Intervals

2.2.  Habitats of Listed Species

2.3.  Exposure (Transport and Fate) Modeling

2.3.1. Aquatic Organisms

2.3.2. Terrestrial Organisms

2.4.  Exposure to Mixtures

2.5.  Monitoring Data

2.6.  Exposure Estimate (with uncertainty)

3.   EFFECTS ANALYSIS

3.1.  Incident Database Review

3.2.  Individuals

3.2.1. Direct Effects (acute, sublethal, and chronic)

3.2.2. Indirect Effects

3.3.  Effects on Critical Habitats

3.4.  Mixture Effects

3.5.  Exposure-Response Estimate (with uncertainty)

4.   RISK CHARACTERIZATION

4.1.  Risk Estimate

4.1.1. Individuals

4.1.2. Populations

4.1.3. Critical Habitat

4.2.  Field and Laboratory Comparisons

4.3.  Risk Description (integration and synthesis)



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