1
Ecological
Effects
Data
Requirements
May
4,
2005
Holiday
Inn
Rosslyn
1900
N.
Fort
Myer
Drive
Arlington,
VA
22209
2
Purpose
of
this
presentation

Provide
an
overview
of
changes
to
existing
ecological
effects
data
requirements

Revised
data
requirements
o
Studies
with
organisms
not
previously
required
in
pesticide
registration

Newly
codified
studies
o
Studies
that
have
been
required
on
a
case­
by­
case
basis
that
merit
inclusion
in
the
data
requirements

Change
of
use
sites
or
conditions
for
existing
studies
o
Modifications
to
requirements
of
existing
studies
for
specified
use
sites
or
chemical
property
conditions
3
Revised
Data
Requirements
Avian
Acute
Oral
Toxicity
Testing
with
a
Passerine
(
songbird)
Species

Uses:


Establish
acute
toxicity
levels
of
chemical
for
risk
assessment
purposes

Support
for
precautionary
label
statements

Evaluate
the
need
for
further
testing

Change

Added
one
additional
test
with
a
passerine
species

Rationale
for
Changes

Address
interspecies
range
of
sensitivity
(
SAP
1996)


Address
concerns
for
potential
greater
sensitivity
of
passerines

When
Required

Outdoor
pesticide
uses
4
Newly
Codified
Studies
Whole
Sediment
Acute
Testing
with
Benthic
Invertebrates

Uses:


Establish
acute
toxicity
levels
of
chemical
for
risk
assessment
purposes

Evaluate
the
need
for
further
testing

Change

Codifies
an
already
conditional
testing
requirement

Rationale
for
Changes

Case­
specific
need
to
assess
the
bioavailability
of
sediment­
bound
compounds
and
characterize
the
possible
impact
to
sedimentdwelling
organisms

Test
is
consistent
with
other
EPA
sediment
effects
assessments

When
required

K
d>
50
mg/
L,
Sediment
T
1/
2<
10
days
5
Newly
Codified
Studies
Whole
Sediment
Chronic
Testing
with
Benthic
Invertebrates

Uses:


Establish
chronic
toxicity
levels
of
chemical
for
risk
assessment
purposes

Evaluate
the
need
for
further
testing

Change

Codifies
an
already
conditional
testing
requirement

Rationale
for
Changes

Case­
specific
need
to
assess
the
bioavailability
of
sediment­
bound
compounds
and
characterize
the
possible
impact
to
sedimentdwelling
organisms

Test
is
consistent
with
USEPA
Contaminated
Sediment
Management
Strategy

When
required

K
d>
50
mg/
L,
Sediment
T
1/
2>
10
days
6
Change
of
Use
Sites
or
Conditions
Avian
Acute
Oral
Toxicity
Testing

Uses:


Establish
acute
toxicity
levels
of
chemical
for
risk
assessment
purposes

Support
for
precautionary
label
statements

Evaluate
the
need
for
further
testing

Change

Conditionally
require
the
testing
of
typical
end
use
products

Clarification
of
existing
conditional
statements,
divide
structurally
complex
statement
into
4
notes

Rationale
for
Changes

End
use
products
may
contain
substances
that
could
enhance
the
toxicity
or
availability
of
the
active
ingredient

Enhance
the
reader's
understanding
of
conditional
statements
7
Change
of
Use
Sites
or
Conditions
Avian
Sub­
acute
Dietary
Toxicity
Testing

Uses:


Establish
acute
toxicity
levels
of
chemical
to
nontarget
wildlife
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
avian
wildlife

Evaluate
the
need
for
further
testing

Changes

Required
(
without
condition)
for
terrestrial,
aquatic,
forestry,
and
residential
outdoor
uses

No
longer
required
for
indoor
and
greenhouse
uses

Conditionally
require
the
testing
of
typical
end
use
products

Rationale
for
Changes

Dietary
exposure
is
a
potentially
significant
route
for
outdoor
uses

Avian
acute
oral
toxicity
represents
the
most
likely
route
of
exposure
under
indoor
uses

Address
potential
greater
toxicity
of
end
use
products
8
Change
of
Use
Sites
or
Conditions
Avian
Sub­
acute
Dietary
Toxicity
Testing

Uses:


Establish
acute
toxicity
levels
of
chemical
to
nontarget
wildlife
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
avian
wildlife

Evaluate
the
need
for
further
testing

Changes

Conditionally
require
for
outdoor
residential
uses
when
LD
50<
100

Conditionally
require
second
species
for
nonfood
outdoor
residential
uses
if
LC
50
is
<
500

Rationale
for
Changes

Ensure
an
adequate
representation
of
potential
avian
sensitivity
assessing
low
pesticide
use
scenarios
and
establishing
label
precautions
9
Change
of
Use
Sites
or
Conditions
Wild
Mammal
Acute
Toxicity
Testing

Uses:


Establish
acute
toxicity
levels
of
chemical
to
nontarget
wildlife
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
avian
wildlife

Evaluate
the
need
for
further
testing

Changes

Eliminate
conditional
requirement
for
aquatic
non­
food
residential
pesticide
uses

Rationale
for
Changes

Allows
for
a
clearer
rationale
for
situations
where
earlier
tier
toxicity
testing
identifies
a
need
for
wild
mammal
testing,
namely
the
aquatic
food
and
nonfood
uses
10
Change
of
Use
Sites
or
Conditions
Avian
reproduction
toxicity
testing

Uses:


Establish
toxicity
levels
of
chemical
to
nontarget
wildlife
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
avian
wildlife

Changes

Eliminate
conditional
requirement
based
on
chemical
stability,

repeat
exposure,
bioaccumulation

EPA
proposes
to
require
these
studies
for
terrestrial
(
food
crop,

feed
crop,
and
nonfood),
aquatic
food
crop
and
nonfood
outdoor,

forestry,
and
residential
outdoor
uses.


Rationale
for
Changes

Accounts
for
recognized
potential
for
short
and
long­
term
exposure
to
produce
reproduction
effects.


Represents
the
current
practice
of
routine
conduct
of
the
study
11
Change
of
Use
Sites
or
Conditions
Simulated
or
Actual
Field
Testing
Birds
and
Mammals

Uses:


Evaluate
risk
assessment
predictions
under
field
use
conditions

Changes

Expand
conditional
requirement
to
require
these
studies
for
all
outdoor
uses.


Require
independent
laboratory
validation
of
environmental
chemistry
methods

Rationale
for
Changes

Initial
risk
assessment
screening
for
some
pesticides
in
non
agricultural
uses
has
shown
that
exposures
can
be
high
enough
to
trigger
concerns
risk
assessment
that
may
warrant
further
fieldlevel
analysis

Method
validation
prior
to
field
study
helps
ensure
that
analytical
method
performance
will
not
invalidate
field
studies
12
Change
of
Use
Sites
or
Conditions
Acute
Toxicity
Testing
with
Freshwater
Fish

Uses:


Establish
toxicity
levels
of
chemical
to
aquatic
vertebrates
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
aquatic
life

Changes

Expand
conditional
requirement
to
require
two
fish
species
for
greenhouse
and
indoor
uses
for
compounds
found
to
be
stable
to
hydrolysis
and
of
moderate
toxicity
LC
50>
1ppm
but
<
10
ppm

Rationale
for
Changes

Fish
toxicity
data
indicate
that
species
sensitivity
can
vary
by
an
order
of
magnitude
or
greater

Additional
test
will
allow
for
precautionary
labeling
or
effluent
criteria
that
more
accurately
reflect
the
toxicity
of
compound
in
case
of
accidental
release
to
the
environment
13
Change
of
Use
Sites
or
Conditions
Acute
Toxicity
Testing
with
Estuarine
and
Marine
Organisms

Uses:


Establish
toxicity
levels
of
chemical
to
estuarine/
marine
organisms
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
aquatic
life

Changes

Drop
conditions
from
the
requirement
for
acute
testing
of
these
organisms
for
outdoor
uses
(
generally
3
of
5
organisms
to
be
tested)


Eliminate
the
need
to
test
for
residential
nonfood
aquatic
uses

Rationale
for
Changes

Aquatic
organism
toxicity
data
indicate
that
species
sensitivity
can
vary
by
an
order
of
magnitude
or
greater
Compounds
may
have
modes
of
action
specific
to
certain
taxonomic
groups

Residential
non­
food
aquatic
uses
are
likely
to
involve
insufficient
pesticide
to
pose
a
significant
exposure
14
Change
of
Use
Sites
or
Conditions
Chronic
Toxicity
Testing
with
Fish
and
Aquatic
Invertebrates

Uses:


Establish
chronic
toxicity
levels
to
aquatic
organisms
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
aquatic
life

Changes

Separate
fish
and
invertebrate
requirements
and
identify
freshwater
and
estuarine/
marine
requirements
separately

Unconditionally
require
freshwater
fish
and
invertebrate
chronic
testing
requirements
for
outdoor
uses

Eliminate
the
need
to
test
for
residential
nonfood
aquatic
uses

Rationale
for
Changes

Exposure
to
both
fish
and
aquatic
invertebrates
can
be
expected
to
occur
as
a
result
of
pesticide
release
to
aquatic
systems

Acute
effects
testing
is
not
a
reliable
indicator
of
chronic
sensitivity
across
taxonomic
groups

Aquatic
nonfood
residential
is
a
small
use
site
15
Change
of
Use
Sites
or
Conditions
Aquatic
Organism
Bioavailability/
Biomagnification

Uses:


Establish
establish
to
potential
for
bioaccumulation
of
a
compound
in
aquatic
organisms
for
risk
assessment
purposes

Changes

Eliminate
the
need
to
test
for
nonfood
residential
and
residential
outdoor
uses

Rationale
for
Changes

Exposure
to
both
fish
and
aquatic
invertebrates
can
be
expected
to
be
minimal
with
insufficient
quantities
released
to
accumulate
in
aquatic
organism
tissues.
16
Change
of
Use
Sites
or
Conditions
Simulated
or
Actual
Field
Testing
for
Aquatic
Organisms

Uses:


Evaluate
risk
assessment
predictions
under
field
use
conditions

Changes

Clarify
that
conditional
requirement
applies
to
turf
(
commercial,
golf
courses,
etc.)


Eliminate
the
need
to
test
for
nonfood
residential
uses

Rationale
for
Changes

Exposure
to
both
fish
and
aquatic
invertebrates
can
be
expected
to
be
minimal
for
nonfood
residential
uses.
17
Change
of
Use
Sites
or
Conditions
Honeybee
Acute
Contact
Toxicity

Uses:


Establish
toxicity
levels
of
chemical
to
honeybees
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
honeybees

Changes

Drop
the
condition
of
pesticide
use
overlap
with
crop
blooming

Require
study
for
terrestrial
food,
feed,
nonfood,
aquatic
food
and
nonfood
(
outdoor),
forestry,
and
residential
outdoor
uses.


Waiver
for
use
practices
that
significantly
reduce
bee
exposure

Rationale
for
Changes

Need
to
address
those
situations
where
blooming,
pollen­
shedding,

and
nectar
producing
parts
of
nontarget
plants
in
or
near
to
application
site
could
attract
bees.
18
Change
of
Use
Sites
or
Conditions
Honeybee
Toxicity
of
Residues
on
Foliage

Uses:


Establish
toxicity
levels
of
chemical
to
honeybees
for
risk
assessment
purposes

Provide
support
for
precautionary
label
statements
to
minimize
adverse
effects
to
honeybees

Changes

Require
testing
of
technical
end
use
product
when
the
formulation
has
one
or
more
ingredients
with
bee
LD
50<
11
ug/
bee
and
use
pattern
is
one
where
bees
could
be
exposed

Rationale
for
Changes

Correct
rule
to
reflect
the
1982
proposed
data
requirement
toxicity
LD
50
threshold
of
11
ug/
bee
19
Change
of
Use
Sites
or
Conditions
Seed
Germination
Study

Uses:


Risk
assessment
for
adverse
effects
on
non­
target
plants

Changes

Eliminate
the
requirement
for
this
study

Rationale
for
Changes

Endpoints
for
this
study
can
be
measured
in
seedling
emergence
study
20
Change
of
Use
Sites
or
Conditions
Seedling
Emergence
and
Vegetative
Vigor

Uses:


Risk
assessment
for
adverse
effectsto
non­
target
plants

Changes

Expand
requirement
for
terrestrial
food
and
feed
crops,
aquatic
food
crops,
and
residential
outdoor
uses

No
vegetative
vigor
studies
required
for
granular
or
bait
products

Test
technical
end
use
product
in
place
of
active
ingredient

Rationale
for
Changes

The
expanded
use
sites
represent
pesticide
application
scenarios
where
drift
and
runoff
may
occur

Granular
or
bait
product
testing
is
not
practical
for
vegetative
vigor
studies
where
pesticide
is
applied
to
plant
surface

End
use
products
can
contain
ingredients
that
enhance
the
bioavailability
or
toxicity
of
active
ingredient

Testing
of
end
use
products
eliminates
need
for
solvent
controls
as
product
already
contains
solvent
21
Change
of
Use
Sites
or
Conditions
Terrestrial
Field
and
Aquatic
Field
Plant
Studies

Uses:


Evaluate
risk
assessment
predictions
under
field
use
conditions

Changes

Expand
requirement
terrestrial
food
and
feed
crops,
aquatic
food
crops,
and
residential
outdoor
uses

Add
Tier
II
studies
as
conditionally
required
for
aquatic
nonfood
residential
uses

Require
independent
laboratory
validation
of
environmental
chemistry
methods

Rationale
for
Changes

The
expanded
use
sites
represent
pesticide
application
scenarios
where
drift
and
runoff
to
adjacent
areas
may
occur

Method
validation
prior
to
field
study
helps
ensure
that
analytical
method
performance
will
not
invalidate
field
studies
