
4/
7/
04
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
4/
7/
04
2
Introduction,
Goals,
and
Objectives
Ingrid
M.
Sunzenauer,

Office
of
Pesticide
Programs,

Environmental
Fate
and
Effects
Division
4/
7/
04
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/
7/
04
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
4/
7/
04
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
4/
7/
04
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
4/
7/
04
7
Initiative:
Phase
I
°
Formed
stakeholder
workgroup
(
ECOFRAM)
in
1997
°
Make
recommendations
regarding
the
development
of
probabilistic
tools
and
methods
°
Issued
draft
reports
in
May
1999
°
Peer
reviewed
in
June
1999
4/
7/
04
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)
4/
7/
04
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
4/
7/
04
10
Initiative:
Phase
II
cont'd
°
Involved
risk
managers
through
workshops
and
briefings
°
Maintained
web
site
°
Participated
in
meetings
with
stakeholders
and
the
States
4/
7/
04
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
4/
7/
04
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
4/
7/
04
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+
4/
7/
04
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
4/
7/
04
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
4/
7/
04
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.
4/
7/
04
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
4/
7/
04
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
4/
7/
04
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
4/
7/
04
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
4/
7/
04
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
4/
7/
04
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
4/
7/
04
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
4/
7/
04
24
For
More
Information
http://
www.
epa.
gov/
oppefed1/
ecorisk/
index.

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