5/
18/
05
1
Environmental
Fate
and
Effects
Division:
Who
We
Are
and
What
We
Do!

Ingrid
M.
Sunzenauer
Environmental
Fate
and
Effects
Division,

Office
of
Pesticide
Programs
5/
18/
05
2
Purpose
Of
Presentation

Mission
of
the
Environmental
Fate
and
Effects
Division
(
EFED)


Processes
to
ensure
sound
science

How
we
evaluate
ecological
risk
from
pesticides
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18/
05
3
EFED's
Mission:

Assessing
Environmental
Risks

Assess
and
characterize
the
potential
ecological
risk
to
non­
target
organisms

Provide
critical
information
to
Agency
regulators
for
registration
and
reregistration
decisions
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18/
05
4
Ensuring
Sound
Science
Therefore,
it
is
essential
to
conduct
high
quality
risk
assessments
that
are:


Scientifically
credible

Follow
the
Agency's
science
and
policy
guidance

Consistent
within
OPP
and
with
other
Agency
offices
Accomplished
by
implementation
of
processes
to
support
sound
science.
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05
5
Sound
Scientific
Processes
1.
Follow
Agency
guidance
2.
Follow
internal
guidance
3.
Subject
to
internal
and
external
peer
review
mechanisms
4.
Evolve
and
improve
by
the
development
of
new
risk
assessment
tools
and
methods
5.
Implemented
through
training
programs
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05
6
1.
Agency
Guidance

US
EPA
"
Ecological
Guidelines"

http://
www.
epa.
gov/
ncea/
ecorsk.
htm

US
EPA
"
Risk
Characterization
Handbook"

http://
epa.
gov/
osp/
spc/
rchandbk.
pdf
5/
18/
05
7
2.
Internal
Guidance

Pesticide
Assessment
Guidelines
 
Guidance
and
standards
on
how
to
conduct
acceptable
studies
and
report
the
results

Standard
Evaluation
Procedures
 
Internal
guidance
on
how
to
evaluate
studies
and
conduct
a
risk
assessment

Miscellaneous
policies,
procedures,

guidance
memoranda,
and
references
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05
8
2.
Internal
Guidance
(
cont'd)


Generic
Format
and
Guidance
Document
 
Provides
the
basic
format
for
EFED's
screening
ecological
risk
assessments

Overview
Document
 
Provides
an
overview
of
the
assessment
process
for
potential
risk
to
listed
species
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18/
05
9
3.
Internal
and
External
Peer
Review
Mechanisms

Internal
peer
review
mechanisms

External
peer
review:
Scientific
Advisory
Panel
 
Multi­
disciplinary,
independent,
peer
review
body
 
National
and
international
scientific
experts
 
Formal
setting
and
opportunity
for
public
comment
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05
10
4.
New
Risk
Assessment
Tools/
Methods

Evolving
process.
As
science
progresses,

the
assessment
process
will
continue
to
develop

Examples
include
 
Refined
(
Probabilistic)
Risk
Assessments
 
Developing
a
new
statistical
package
for
analyzing
plant
data
 
Developing
shells
PE4
and
Express
for
PRZM/
EXAMS
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18/
05
11
5.
Training
EFED
staff
and
other
OPP
Divisions

EPA's
Ecological
Risk
Assessment
Guidelines

EPA's
Risk
Characterization
Guidelines
EFED
staff

Generic
Format
Document

Various
statistical
models
and
use
of
GIS
Extensive
training
currently
in
progress
for
new
EFED
employees
and
others
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05
12
Ecological
Risk
Assessments
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18/
05
13
Ecological
Risk
Assessments:

Screening
Assessments

Evaluate
the
results
from
pesticide
exposure
to
ecological
resources

Based
on
1.
Best
available
scientific
and
commercial
data,

and
2.
Sound
scientific
processes.


Provide
critical
information
to
Agency
regulators
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18/
05
14
Best
Available
Data

Registrant
submitted
data
for
exposure
and
effects
(
CFR
40
part
158)


Open
literature
data
for
effects

Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)
(
6)(
a)(
2)
data
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18/
05
15
Effects
Data:
CFR
40
Part
158

Evaluates
the
acute
and
chronic
effect
of
a
pesticide

Limited
data
set
predicts
toxicity
levels
to
a
large
number
of
potentially
exposed
species

Data
includes
birds,
fish,
plants,
aquatic
organisms
and
others

Generally
little
or
no
data
on
reptiles,
amphibians,

and
other
taxa

Data
used
are
based
on
the
most
sensitive
species
tested

Proposed
expanding
requirements
to
include
additional
species
and
routes
of
exposure
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18/
05
16
Other
Sources
of
Effects
Data
ECOTOX

Locates
publicly
available
chemical
toxicity
data
for
aquatic
and
terrestrial
organisms

Interim
guidance
issued
outlining
evaluation
criteria
to
ensure
the
best
available
data
are
used
Section
6(
a)(
2)
of
FIFRA

Requires
registrants
to
submit
adverse
effects
information
about
their
products
to
the
EPA

Includes
incident
data
and
other
adverse
effects
information
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05
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Exposure
Data:
CFR
40
Part
158

Where
and
how
the
pesticide
moves
in
the
environment
and
how
long
it
will
persist

What
degradation
products
are
produced,
in
what
quantities
and
under
what
processes

Includes
chemical
degradation,
metabolism,

mobility,
and
field
studies

No
new
tests!
Just
codifying
current
practices.
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Risk
Management
Risk
Management
Communicating
Results
to
the
Risk
Manager
Communicating
Results
to
the
Risk
Manager
Integrate
Available
Information
PROBLEM
FORMULATION
Source
and
Exposure
Characteristics
Ecosystem
Potentially
at
Risk
Ecological
Effects
Assessment
Endpoints
Conceptual
Model
Analysis
Plan
ANALYSIS
Characterization
of
Exposure
Characterization
of
Ecological
Effects
Measures
of
Exposure
Measures
of
Exposure
Measures
of
Ecosystem
And
Receptor
Characteristics
Measures
of
Effect
Measures
of
Effect
Exposure
Analysis
Ecological
Response
Analysis
Exposure
Profile
Exposure
Profile
Stressor­
Response
Profile
Stressor­
Response
Profile
RISK
CHARACTERIZATION
Risk
Estimation
Risk
Description
As
Necessary
Acquire
Data,
Iterate
Process,
Monitor
Results
FRAMEWORK
FOR
ECOLOGICAL
RISK
ASSESSMENT
FRAMEWORK
FOR
ECOLOGICAL
RISK
ASSESSMENT
1.
Management
Goals
2.
Management
Options
3.
Scope,
Complexity,

and
Focus
4.
Resources
5.
Scheduling
Planning
(
Risk
Assessor/

Risk
Manager
Dialogue)
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05
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Planning
a
Risk
Assessment:

Planning
Dialogue

Distinct
from
the
risk
assessment
process

Occurs
up
front
between
risk
managers
and
risk
assessors

Key
steps
are
 
Describing
management
goals
 
Identifying
potential
risk
management
options
 
Discussing
the
focus,
scope,
and
complexity
of
assessment
 
Identifying
resources
and
setting
schedules
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05
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Basic
Components
of
the
Risk
Assessment
Process
 
Brief
Overview
1.
Problem
Formulation

Begins
the
scientific
process

Provides
the
foundation
for
the
assessment

Integrates
available
information
and
provides
an
early
identification
of
data
gaps

Defines
assessment
endpoints
and
proposes
conceptual
model

Concludes
with
an
analysis
plan
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05
21
2.
Analysis

Review
the
available
data

Develop
exposure
characterization
 

Measures
of
exposure:
Describe
the
pesticide's
existence
and
movement
in
the
environment

Develop
effects
characterization
 

Measures
of
Effect:
Describe
the
effect
of
the
pesticide

Evaluate
uncertainty
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05
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3.
Risk
Characterization

Represents
the
final
step
in
the
assessment
process

Integrates
and
synthesizes
the
effects
and
exposure
characterizations
into
an
overall
conclusion

Includes
a
description
of
assumptions,

limitations,
and
uncertainties

Is
complete,
informative,
and
useful
for
decision
makers
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3.
Risk
Characterization
cont'd

Risk
Estimation
 
Integrates
exposure
and
effects
data
 
Accomplished
by
calculating
a
risk
quotient
(
RQ)

 
RQ
compared
with
a
Level
of
Concern
(
LOC),
the
criteria
used
to
indicate
potential
risk

Risk
Description
 
Provides
interpretation
of
risks
based
on
assessment
endpoints
 
Informative
for
the
risk
manager,
who
will
use
the
assessment
to
make
a
risk
management
decision
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18/
05
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Final
Thoughts
.
.
.
.
.


Primary
mission
is
to
provide
Agency
regulators
with
scientifically
sound
ecological
risk
assessments

Accomplished
by
 
Following
sound
scientific
processes
in
evaluating
the
available
data
from
40
CFR
158
and
 
In
conducting
the
ecological
risk
assessments
