Progress Report of the Ecological Committee on FIFRA Risk Assessment Methods:
1. Workgroup Formation and Process

I. M. Sunzenauer, and D.S. Spatz,
Office of Pesticide Programs,
U.S. Environmental Protection Agency,
Washington, DC 20460;

and

D. Fischer,
Agriculture Division,
Bayer Corporation,
Stilwell, KS 66085

On this Page

May 1996
SAP Recommendations
EFED Response to the SAP
December 1996 - Formation of the Workshop Organizing Committee (WOK)
Responsibilities and Accomplishments of the WOK
June 1997 - Formation of the ecological Committee On FIFRA Risk Assessment Methods (ECOFRAM)
1001 Risk Manager Questions
Charge to the Terrestrial and Aquatic Workgroups
Workgroup Members: Aquatic (Exposure and Effects)
Workgroup Members: Terrestrial (Exposure and Effects)
August 1997 - Progress of ECOFRAM Workgroups
- Terrestrial Workgroup Approach
- Aquatic Workgroup Approach
Milestones
On the Web

May 1996

The Environmental Fate and Effects Division within the Office of Pesticide Programs presented their Ecological Risk Assessment Methodology to the FIFRA Scientific Advisory Panel (SAP).

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SAP Recommendations

While recognizing and generally reaffirming the utility of OPP's current ecological risk assessments, the Panel indicated that OPP, due to data gaps, is "trapped" in single point deterministic risk assessments and should move toward probabilistic types of assessments that address the magnitude, uncertainty and variation involved in the provided estimates.

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EFED Response to the SAP

Commitment to design a process for developing and validating probabilistic assessment tools and methodologies.
Methods developed will reflect a solid foundation in environmental toxicology and environmental fate, including the transport, degradation, and accumulation of pesticides in the environment.
Commitment to involve stakeholders- outreach.

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December 1996
Formation of the Workshop Organizing Committee (WOK)

WOK Committee Members and Affiliations
WOK Committee Member	Affiliations
Edward Fite	EPA
Paul Mastradone	EPA
Ron Parker	EPA
Dana Spatz	EPA
Ann Stavola	EPA
Ingrid Sunzenauer	EPA
Jim Wolf	EPA
Dave Fischer	Bayer Corp.
Jim Gagne	Am. Cyanamid
Dennis Laskowski	Dow Elanco
Ray McAllister	ACPA
Kevin Reinert	Rohm and Haas
Rick Stanton	Valent USA

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Responsibilities and Accomplishments of the WOK

Outreach-
Pesticide Program Dialog Committee (PPDC)
State FIFRA Issues Research and Evaluation Group (SFIREG)
Professional Meetings (ACS, SETAC, SRA)
Invited participants to ECOFRAM- aquatic and terrestrial workgroups.
Held June 23, 1997 open workshop. "Evaluating Ecological Risk: Developing FIFRA Probabilistic Tools and Processes."
Two additional workshops are planned.
Summer 1998- workgroups will share results and obtain peer review.
Fall 1998- open meeting for ECOFRAM to share final results and recommendations.

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June 1997 - Formation of the Ecological Committee On FIFRA Risk Assessment Methods (ECOFRAM)

Responsible for conducting the primary review of the current assessment process and developing new tools and methodologies.
Identify additional methods, development and validation needs to ensure that the assessment process supports environmental decisions that are scientifically defensible.

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1001 Risk Manager Questions

What is the magnitude and probability of these effects?
What are the effects of concern?
Why are they of concern?
Will there be population(s) impacts?
Will the population(s) recover?
Are the effects seen across different species?
Will the effects influence density and diversity?
How confident are we in our estimate of the effects?
What models did we use?
Have they been validated?
Are they widely accepted and scientifically sound?
Is there any monitoring data?
Which data are more reliable, lab or monitoring?
How have you factored the monitoring data into your assessment?

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Charge to the Terrestrial and Aquatic Workgroups

Develop processes and tools for predicting the magnitude and probabilities of adverse effects to non-target aquatic and terrestrial species resulting from the use of pesticides.
Standardized procedures that integrate estimates of pesticide exposure with knowledge about potential adverse effects. Account for biological factors such as species sensitivity, habitat, dietary/behavior mechanisms. Account for environmental factors such as transport, accumulation, fate, climate, application techniques, and formulation.
Address uncertainty in a quantitative manner and recommend procedures to appropriately validate tools and assumptions.
Keep within the context of the FIFRA regulatory perspective and follow the outline provided by EPA's Framework for Ecological Risk Assessment (U.S. EPA/ORD, 1992).

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Workgroup Members: Aquatic (Exposure and Effects)

Aquatic Workgroup Members (Exposure) and Affiliations
Aquatic Exposure Workgroup Member	Affiliation
Paul Hendley (Chair)	Zeneca
James Baker	Iowa State Univ.
Lawrence Burns	ORD/EPA
David Farrar	OPP/EPA
Alan Hosmer	Novartis
R. David Jones	OPP/EPA
Walton Low	USGS
Mark Russell	Du Pont
Mari Stavanja	FL Bureau of Pesticide
W. Martin Williams	Waterborne Env.
James Wolf	OPP/EPA

Aquatic Workgroup Members (Effects) and Affiliations
Aquatic Effects Workgroup Member	Affiliation
Jeff Giddings (Chair)	Springborn
Larry Barnthouse	McLaren-Hart
Jerry Clark	Natl. Fish & Wildlife Fou.
A. Tilghman Hall	Bayer
Michael McKee	Monsanto
Michael Newman	Univ. of Georgia
Kevin Reinert	Rohm and Haas
Robert Sebastien	Health Canada
Ann Stavola	OPP/EPA
Keith Solomon	Univ. of Guelph
Les Touart	OPP/EPA
Randy Wentsel	U.S. Army

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Workgroup Members: Terrestrial (Exposure and Effects)

Terrestrial Workgroup Members (Exposure) and Affiliations
Terrestrial Exposure Workgroup Member	Affiliation
Edward Fite (Chair)	OPP/EPA
Larry Brewer	Ecotox. & Biosystems
Kristin Brugger	Du Pont
David Fischer	Bayer
Andy Hart	UK MAFF
Dennis Laskowski	DowElanco
Paul Mastradone	OPP/EPA
Robert Menzer	ORD/EPA
Daryl Morehead	Texas Tech Univ.
Henry Nelson	OPP/EPA
Raymond O'Connor	Univ. of Maine
Ron Parker	OPP/EPA
Duane Wolf	Univ. of Arkansas

Terrestrial Workgroup Members (Effects) and Affiliations
Terrestrial Effects Workgroup Member	Affiliation
Michael Willig (Chair)	Texas Tech
Alain Baril	Environment Canada
Richard Bennett	Eco. Planning & Tox
John Eisemann	OPP/EPA
William Erickson	OPP/EPA
Susan Ferenc	USDA
Michael Fry	National Audubon Soc.
James Gagne	American Cyanamid
Michael Hooper	Clemson Univ.
Thomas Lacher	Texas A&M
Monte Mayes	Dow Chemical
Diana Post	Rachel Carson Council
Robert Ringer	Michigan State (Ret.)
Jennifer Shaw	Zeneca

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August 1997 - Progress of ECOFRAM Workgroups

Terrestrial Workgroup Approach

Define assessment questions (probability and magnitude of effects).
Develop conceptual model (exposure and effects).
Identify major variables that influence effects to nontarget species.
Define distribution for these variables or how to estimate them.
Construct models and perform sensitivity analysis.
Identify data needed to support models.
Develop risk assessment process incorporating the models.
Define additional developmental work and validation requirements.

Aquatic Workgroup Approach

Time-to-event analysis
Pulsed exposures
Life table and population models
Intraspecific variability in sensitivity
Interspecific variability in sensitivity
Sensitivity distribution subsets, resampling
Ecosystem models
Mesocosms
Behavioral effects
Sediment toxicity/Equilibrium partitioning

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Milestones

Activities and Dates for EPA's Ecological Risk Assessment Initiative
Activity	Date
Formation of WOK	December 1996
Formation of ECOFRAM and Initial Outreach Workshop	June 1997
Consultation with SAP	September 1997
Presentation of Interim Progress at Professional Society Meetings	Fall/Winter 1997
ECOFRAM Reports	Spring 1998
Peer Review Workshop	Fall 1998
SAP Review of Proposed Ecological Risk Assessment Improvements	Winter 1998
OPP Implements Use of New Tools and Processes	Spring 1999