1
A
Discussion
with
the
FIFRA
SAP
Regarding
the
Terrestrial
and
Aquatic
Level
II
Refined
Risk
Assessment
Models
(
Version
2.0)

March
30
 
April
2,
2004
Office
of
Pesticide
Programs,

Environmental
Fate
and
Effects
Division
2
Introduction,
Goals,
and
Objectives
Ingrid
M.
Sunzenauer,

Office
of
Pesticide
Programs,

Environmental
Fate
and
Effects
Division
3
Overview
of
Presentation
°
Background
on
the
Initiative
to
Revise
the
Ecological
Assessment
Process
°
Conceptual
Risk
Assessment
Process
°
Level
II
Models,
Version
1.0
°
Level
II
Models,
Version
2.0
°
Steps
to
Finalize
the
Models
°
Purpose
of
this
Consultation
4
Background
1996
SAP
Meeting
°
Reaffirmed
the
value
of
the
current
assessment
process
as
a
deterministic
screening
method
°
Provided
comments
for
further
improvement,
including
the
recommendation
for
developing
probabilistic
tools
and
methods
5
Initiative
to
Revise
the
Ecological
Assessment
Process
Following
the
SAP
recommendations
and
in
response
to
risk
management
questions,

an
initiative
began
in
1997
to
develop
°
A
conceptual
approach
for
refining
the
risk
assessment
process
°
Probabilistic
tools
and
methods
under
the
FIFRA
regulatory
framework
6
Goals
of
Initiative
Implement
a
refined
assessment
process
that
°
Addresses
a
broad
spectrum
of
effects
°
Reflects
more
realistic
use
scenarios
and
field
conditions
°
Incorporates
probabilistic
tools
and
methods
°
Designed
to
rely
on
existing
data
requirements
for
registration
at
lower
tiers
°
Focuses
additional
data
requirements
in
upper
tiers
for
reducing
uncertainty
7
Initiative:
Phase
I
°
Formed
stakeholder
workgroup
(
ECORAM)
in
1997
°
Make
recommendations
regarding
the
development
of
probabilistic
tools
and
methods
°
Issued
draft
reports
in
May
1999
°
Peer
reviewed
in
June
1999
8
Initiative:
Phase
II
°
Formed
Implementation
Team
°
Began
with
technical
evaluation
of
ECOFRAM
reports
and
peer
review
comments
°
Proposed
conceptual
process
°
Reviewed
by
the
SAP
in
2000
°
Developed
Level
II
models
(
Version
1.0)

°
Reviewed
by
the
SAP
in
2001
°
Refined
models
(
Version
2.0)
9
Initiative:
Phase
II
cont'd
°
Participated
in
scientific
exchange
 
National
and
international
professional
meetings
 
Briefings
with
other
Divisions
and
other
Offices
°
Collaborating
with
EPA's
Office
of
Research
and
Development
and
the
Office
of
Economy
and
Environment
10
Initiative:
Phase
II
cont'd
°
Involved
risk
managers
through
workshops
and
briefings
°
Maintained
web
site
°
Participated
in
meetings
with
stakeholders
and
the
States
11
Conceptual
Process
Level
I
°
Current
screening
level
Level
II
°
Initial
estimate
of
probability
and
magnitude
of
effects
°
Designed
to
rely
on
existing
data
sets
°
Plan
to
include
simplistic
estimates
of
population
impacts
in
the
future
12
Conceptual
Process
cont'd
Levels
III
and
IV
°
More
refined
predictions
of
probability
and
magnitude
of
impacts
°
More
refined
use
scenarios
°
Will
address
population
impacts
°
May
potentially
require
new
information
or
data,
especially
at
Level
IV
13
Level
II
Models,
Version
1.0
°
Developed
Version
1.0
of
the
models
°
Used
to
conduct
a
probabilistic
risk
assessment
for
a
specific
pesticide
°
Reviewed
by
the
SAP
using
a
generic
chemical,
ChemX
°
Aquatic
risk
assessment
Level
II
°
Terrestrial
risk
assessment
Level
II+
14
Terrestrial
Level
II
Model,

Version
2.0
°
Evaluates
avian
acute
mortality
levels
from
oral,

dermal,
and
inhalation
exposure
°
Uses
generic
species
from
feeding
and
nesting
guilds
or
specific
species
°
Includes
a
new
model
for
estimating
residues
in
puddles
°
Spatial
scale
 
pesticide
treated
field
and
surrounding
area
°
Temporal
scale
 
exposure
at
and
following
a
single
application
15
Aquatic
Level
II
Model,

Version
2.0
°
Evaluates
impacts
to
freshwater
and
saltwater
fish
and
aquatic
invertebrates
 
Acute
mortality
 
Chronic
survival,
growth
and/
or
reproduction
°
Spatial
scale
is
a
 
Single
treated
field
 
Scenario
specific
water
body
16
Aquatic
Level
II
Model,

Version
2.0
°
Temporal
scale
is
multiple
applications
over
multiple
years
°
Incorporates
new
surface
water
fate
model
 
Allows
volume
to
vary
according
to
weather
conditions
 
Provides
daily
variations
in
parameter
values,

such
as
wind
speed,
temperature,
flows,
etc.
17
Finalizing
the
Level
II
Models,

Version
2.0
°
Conduct
sensitivity
analyses
°
Complete
documentation
of
models
according
to
QA/
QC
procedures
°
Complete
alpha­
testing
of
the
model
°
Develop
user
manual
°
Conduct
beta­
testing,
focusing
on
rigorous
case
studies
which
will
test
model
features
and
components
°
Develop
procedures
and
mechanisms
for
model
maintenance
18
Moving
Toward
Implementation:

Training
°
Risk
assessors
 
Technical
training:
Use
of
the
models
and
the
development
of
a
robust
risk
characterization
°
Risk
managers
 
Briefings:
Provide
model
overview
and
sample
case
studies
19
Moving
Toward
Implementation:

Outreach
°
Updating
web
site
°
Participating
in
meetings
with
stakeholders
°
Conducting
briefings
for
other
Federal
agencies
°
Participating
in
EPA
Probabilistic
Risk
Assessment
Colloquium
and
national
and
international
professional
meetings
20
Why
Are
We
Here?

Purpose
of
Consultation
Focusing
on
model
modifications
from
Version
1.0
°
Seek
general
comments
and
recommendations
on
these
modifications
°
Maintain
an
open
and
transparent
process
to
keep
the
public
informed
°
Provide
an
opportunity
for
public
comment
21
Agenda
Day
1:

°
Introduction
°
Overview
of
Terrestrial
Level
II
Model
(
Version
2.0)

°
Public
Comment
°
Panel
Discussion
Day
2:

°
Panel
Discussion
cont'd
°
Adjournment
22
Agenda
cont'd
Day
3:

°
Introduction
°
Overview
of
Aquatic
Level
II
Model
(
Version
2.0)

°
Public
Comment
°
Panel
Discussion
Day
4:

°
Panel
Discussion
cont'd
°
Adjournment
23
Implementation
Team
Chair:
Ingrid
Sunzenauer
Terrestrial
Team
°
Edward
Fite,
Chair
°
Tim
Barry,
OEE
°
Edward
Odenkirchen
°
Dirk
Young
Aquatic
Team
°
Donna
Randall,
Chair
°
Tim
Barry,
OEE
°
Marietta
Echeverria
°
Dirk
Young
Supporting
Members
°
Stephanie
Irene
°
Doug
Urban
(
Deceased)

Additional
Contributors
°
James
Carleton
°
Christine
Hartless
°
Henry
Nelson
24
For
More
Information
http://
www.
epa.
gov/
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ecorisk/
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