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Anne Fairbrother, D.V.M., Ph.D.

Principal Scientist

Assessing Risks of Pesticides 

to Listed Species:

Operationalizing National Academy 

of Sciences Recommendations

U.S. EPA Office of Pesticide Programs

Public Workshop

April 2014 • Arlington, Virginia
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NAS Report—April 2013

 Addressed key issues to 

harmonize risk 

assessments across 

agencies – Use of best available 

science

– Sublethal, cumulative, and 

indirect effects

– Mixtures and inerts – Models – Interpretation of uncertainty – Geospatial datasets and 

information
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Three Step Process

EPA, USFWS, NOAA: “Interim Approaches for NationalLevel Endangered Species...Assessments”

 Step 1: Determine whether action “may affect” a listed species 

or its critical habitat. If yes, action agency has the option of 

formal or informal consultation.

 Step 2 (Informal Consultation): Determine whether action is 

“likely to adversely affect” a listed species or its critical habitt. If 

no, and FWS or NMFS agrees, no further consultation. If yes, 

formal consultation required.

 Step 3 (Formal Consultation): FWS or NMFS must determine 

whether proposed action is likely to jeopardize the existence of 

the listed species and issues a biological opinion.
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Step 1 (EPA)

May Affect?

Step 2 (EPA)

Informal Consultation

Likely to Adversely Affect?

YES – Option 1

Concurrence?

FWS or NMFS

Step 3 (FWS or NMFS)

Formal Consultation

Jeopardy?

YES

Problem

Formulation

Exposure

Analysis

Effects

Analysis

Risk

Characterization

ESA Process

NO

REGISTRATION 

OR REREGISTRATION

OF PESTICIDE

Problem

Formulation

Exposure

Analysis

Effects

Analysis

Risk

Characterization

Problem

Formulation

Exposure

Analysis

Effects

Analysis

Risk

Characterization

NO

YES – Option 2

EPA DECIDES WHETHER AND UNDER 

WHAT CONDITIONS TO REGISTER 

PESTICIDE 

YES

NO

NO

YES

ESA Process ERA Process
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Step 1 

No Effect/May Affect Determination and Action Area: 

 Overlap of the action area with the species’ ranges and 

designated critical habitats

– Species or critical habitats that overlap with the action area 

during the time of pesticide application

– Geography and phenology

 Hazard classification

– Assessment of potential to cause toxicity in organisms

 Birds

 Mammals

 Fish

 Invertebrates (terrestrial and aquatic)

 Plants
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Interim Approaches for National-Level 

Endangered Species... Assessments

Readily available geospatial 

data sets will be used to 

establish agricultural and nonagricultural pesticide use areas. 

The Agencies will develop a 

proposal to aggregate data 

over multiple time periods to 

more fully account for past, 

present and reasonable future 

use area changes.

Sources of information

 USDA National Agricultural 

Statistics Service (NASS) 

Census of Agriculture data 

(county level) 

 The National Land Cover 

Database (NLCD) 

 The Cropland Data Layer 

(CDL) and/or CDL aggregated 

by years 
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http://www.nass.usda.gov/Charts_and_Maps/Crops_County/cr-pl.asp
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http://www.nass.usda.gov/Charts_and_Maps/Crops_County/cr-pl.asp
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http://www.nass.usda.gov/Charts_and_Maps/Crops_County/cr-pl.asp
10
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Interim Approaches for National-Level 

Endangered Species... Assessments

For species range and 

designated critical habitat 

geospatial information, priority 

and weight will be given to 

spatial data provided by the 

Services. If sub-county spatial 

data are not available from the 

Services for particular species 

and/or designated critical 

habitats, an interim approach 

for supplementing listed 

species locations will be used 

Sources of information

 FWS Environmental 

Conservation Online System 

(ECOS)

– Information, Planning, and 

Conservation System (IPaC)

– Critical Habitat Portal

 FIFRA Endangered Species 

Task Force (FESTF) database

 NatureServe
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http://ecowatch.com/2013/08/30/proposal-weakens-endangered-species-protections-on-public-lands/

Number of Federally Listed Species
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Species of Potential Concern (e.g., Spring)

 Corn

– Birds

 Species 1

 Species 2

 Species 3

– Mammals

 Species 1

 Species 2

 Species 3

– Plants

 Species 1

 Species 2

 Species 3

 Soybean

– Birds

 Species 1

 Species 2

– Mammals

 Species 1

 Species 2

 Species 3

– Plants

 Species 1

 Cotton

– Birds

 Species 2

 Species 3

– Mammals

 Species 1

– Plants

 Species 2

 Wheat

– Birds

 Species 3

– Mammals

 Species 1

 Species 2

– Plants

 Species 1
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 Species of concern

– Birds

– Mammals

– Plants

– Fish

– Invertebrates (soil)

– Invertebrates (aquatic)

Initial Hazard Assessment

Retain or Eliminate Species Classes (direct effects)

 Toxicity data from 

standard toxicity tests

– Yes / no

 Mechanism of action

– Broad spectrum versus 

targeted species

 Read across

– Known data from similar 

chemicals
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 Species of concern

– Birds

– Mammals

– Plants

– Fish

– Invertebrates (soil)

– Invertebrates (aquatic)

Initial Hazard Assessment

Retain or Eliminate Species Classes (critical habitat attributes)

 Critical habitat attributes

– Cover type

– Forage

– Etc.

 Direct effect of pesticide 

on habitat attributes

– Yes / no from previous slide
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Interim Approach

Effects

 Action Area will be based on 

the lowest relevant toxicity 

value for the most sensitive 

species in the environment that 

results in the farthest distance 

from the use site(s) based on 

the effects thresholds described 

below. The aquatic portions of 

the action area will 

incorporate/characterize 

downstream transport. 

Exposure

 Estimated environmental 

concentrations (EECs) will be 

based largely on modeled 

estimates

– PRZM-EXAMS

– AgDRIFT

– AGDISP

– Variable Volume Pond Model

– T-REX

– TerrPlant 
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Interim Approach

Effects

 Action Area will be based on 

the lowest relevant toxicity 

value for the most sensitive 

species in the environment that 

results in the farthest distance 

from the use site(s) based on 

the effects thresholds described 

below. The aquatic portions of 

the action area will 

incorporate/characterize 

downstream transport. 

One in a million = LD0.000001
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But Most Importantly

 Why spend so much time at 

Step 1?

 Focus should be on problem 

formulation

 Then go to Step 2 and do a 

quantitative risk analysis of 

exposure and effects for each 

species of potential concern

– Include distributions, etc. for 

appropriate uncertainty analysis

http://en.wikipedia.org/wiki/...
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Conclusion

 Interim Approach document is a significant step forward

 Further discussion is needed for how to operationalize 

the approach, particularly for Step 1

– Consideration given to need for high through-put at Step 1

– Quantitative analyses are preferred for Steps 2 and 3

 Include quantitative assessment of uncertainties to achieve 

desired statements of probabilities

– Approach for Step 3 has not yet been identified

 May constrain the discussion for Step 2 if there is no vision for 

how the output will inform the next step