Document ID: EPA-HQ-OPP-2002-0311-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-11-25T05:00Z

Page
1
of
7
PROCESS
FOR
ASSESSING
POTENTIAL
RISKS
TO
ENDANGERED
AND
THREATENED
SPECIES
AND
CONSULTATION
WITH
THE
NATIONAL
MARINE
FISHERIES
SERVICE
AND
THE
U.
S.
FISH
AND
WILDLIFE
SERVICE
U.
S.
Environmental
Protection
Agency
2002
A.
Consultation
Procedures
Regulations
governing
ESA

s
section
7
consultation
procedures
pursuant
to
section
7
of
ESA
are
codified
in
50
CFR
Part
402.
A
discussion
of
these
regulations
in
reference
to
EPA

s
registration
and
reregistration
activities
follows.

1.
A
"
conference"
is
designed
to
identify
potential
problems
between
an
agency
action,
such
as
pesticide
registration,
and
a
species
proposed
to
be
listed
(
i.
e.,
before
it
is
listed)
under
ESA.
There
is
also
a
more
formal
conference
procedure
(
50
CFR
402.10
(
d)
and
(
e)),
which
follows
the
same
basic
procedures
as
a
formal
consultation,
except
that
again
the
species
is
not
yet
listed.
The
EPA
hopes
to
make
use
of
formal
conferences
in
the
future,
where
appropriate,
to
provide
more
timely
protection
to
listed
species.

2.
An
"
early
consultation"
attempts
to
identify
potential
conflicts
between
listed
species
and
their
critical
habitats,
and
proposed
actions
prior
to
applying
for
the
Federal
pesticide
registration.
This
type
of
consultation
is
conducted
between
the
Federal
agency,
EPA,
and
FWS,
but
involves
the
registrant
or
applicant
throughout
the
process.
Pesticide
registration
has
not
used
early
consultation
because
the
amount
and
quality
of
data
needed
from
the
registrant
would
be
equivalent
to
that
needed
for
registration,
and
the
process
would
provide
no
benefit.
Aspects
of
this
consultation
procedure
(
i.
e.,
early
involvement
of
the
applicant)
can
be
useful
in
expediting
public
health
emergency
exemption
consultations.

3.
A
"
biological
assessment"
evaluates
the
potential
effects
of
Federal
action(
s)
on
listed
species.
species
that
are
proposed
to
be
listed,
and
their
critical
habitats.
The
goal
is
to
determine
which
species
or
habitats
are
likely
to
be
adversely
affected
and
to
determine
if
consultation
is
necessary.
Biological
assessments
are
only
required
for
major
construction
activities.
An
agency
may
request
from
FWS
a
list
of
species
that
may
be
in
the
area
of
concern.
This
process
is
only
required
within
the
biological
assessment
process
but
can
be
requested
for
any
action.
The
FWS
is
to
provide
such
a
list
to
the
agency
within
30
days.

4.
An
"
informal
consultation"
is
an
optional
process
between
a
Federal
agency
and
FWS
and
is
designed
to
assist
the
Federal
agency
in
determining
if
formal
consultation
and/
or
a
conference
are
required.

5.
A
"
formal
consultation"
is
the
process
in
which
a
Federal
agency
first
determines
if
an
agency
action
such
as
pesticide
registration
"
may
affect"
a
listed
species
or
its
critical
habitat.
If
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2
of
7
"
no
effect"
is
determined,
the
process
concludes.
If
there
is
a
"
may
affect"
determination,
then
the
agency
initiates
formal
consultation
with
FWS
which
describes
(
ii
the
action,
(
ii)
the
specific
area(
s)
affected,
(
iii)
any
species
or
critical
habitats
that
may
be
affected.
(
iv)
how
the
action
will
impact
the
species
or
habitats.
(
v)
any
cumulative
effects,
and
(
vi)
any
other
relevant
information.
The
FWS
then
concludes
the
formal
consultation
within
90
days,
unless
extended
by
mutual
agreement.

Within
45
days
after
the
conclusion
of
the
formal
consultation,
FWS
issues
a
written
finding
called
a
Biological
Opinion
to
the
Federal
agency.
During
this
45­
day
time
period,
the
Federal
agency
may
request
a
draft
of
the
Opinion
primarily
to
analyze
the
reasonable
and
prudent
alternatives.
This
cannot
extend
the
45­
day
period
by
more
than
10
days
unless
an
extension
is
mutually
agreed
upon.

The
Biological
Opinion
should
include
a
summary
of
the
information
on
which
the
consultation
is
based,
and
a
discussion
of
the
effects
of
the
action
on
the
listed
species
or
critical
habitats,
including
a
FWS
determination
on
whether
the
action
is
likely
to
jeopardize
the
continued
existence
of
a
species
or
result
in
the
destruction
or
adverse
modification
of
critical
habitat.
Incidental
take
of
species
for
which
there
is
a
"
may
affect"
but
is
not
likely
to
be
jeopardized,
will
be
identified.
If
possible,
FWS
will
identify
reasonable
and
prudent
alternatives
to
the
action,
such
as
modification
of
the
use
of
the
pesticide,
that
the
agency
or
registrant
can
take
to
avoid
jeopardy.
In
addition,
the
Biological
Opinion
will
identify
(
i)
the
amount
or
extent,
if
any,
of
acceptable
incidental
take
of
the
species,
(
ii)
reasonable
and
prudent
measures
to
the
action
that
will
minimize
the
impact.
(
iii)
terms
and
conditions
to
implement
the
reasonable
and
prudent
measures,
and
(
iv)
procedures
to
handle
or
dispose
of
species
taken.
The
FWS
can
also
provide
conservation
recommendations
that
the
agency
may
or
may
not
consider.

Issuance
of
the
Biological
Opinion
terminates
the
formal
consultation
process.
If
the
Federal
agency
cannot
comply
with
a
Biological
Opinion,
it
may
apply
for
an
exemption
under
section
7
of
ESA.

6.
A
"
reinitiation
of
consultation"
is
required
if
(
i)
incidental
take
is
exceeded,
(
ii)
new
information
is
obtained
which
may
affect
the
assessment(
s)
of
species
or
critical
habitats
in
a
manner
not
previously
considered,
(
iii)
the
action
is
subsequently
modified
and
causes
an
effect
to
the
species
or
habitat
not
previously
considered,
and
(
iv)
new
species
or
critical
habitats
have
been
designated
that
may
be
affected
by
the
action.

B.
The
EPA

s
"
May
Affect"
Determinations
Ecological
risk
from
pesticide
use
is
a
function
of
toxicity
and
environmental
exposure
(
Ref.
1).
This
Unit
summarizes
risk
assessment
procedures
used
by
EPA
and
indicates
how
these
standard
procedures
are
adapted
for
determining
whether
a
pesticide
"
may
affect"
listed
species.
The
EPA
evaluates
data
and
risks
in
a
tiered
fashion.
The
first
risk
evaluation
is
based
upon
laboratory
toxicity
and
environmental
fate
data,
If
the
initial
evaluation
indicates
a
significant
Page
3
of
7
concern,
then
EPA
requests
registrants
to
supply
additional
laboratory
and/
or
field
data
in
order
to
refine
the
risk
assessment.

1.
Toxicity
evaluations.
Data
used
in
assessing
toxicity
include
acute
and
chronic
test
data.
For
acute
toxicity,
EPA
evaluates
LC5O
and
LD5O
tests,
which
are
submitted
in
response
to
EPA
data
requirements
(
40
CFR
Part
158).
The
LC5O
is
the
statistically
derived
estimate
of
the
concentration
(
median
lethal
concentration)
that
would
cause
mortality
to
50
percent
of
the
test
population.
in
contrast,
the
LD5O
is
the
statistically
derived
estimate
of
the
single
dose
(
median
lethal
dose)
that
would
cause
mortality
to
50
percent
of
the
test
population.
Both
tests
are
conducted
with
surrogate
species
that
are
used
to
evaluate
the
potential
risk
to
other
species.

To
assess
acute
toxicity
of
pesticides
to
birds,
EPA
guidelines
require
one
LD5O
study
for
an
upland
game
bird
(
preferably
bobwhite
quail)
or
waterfowl
(
preferably
mallard
duck)
and
one
LC5O
study
for
each
species.
To
assess
toxicity
to
aquatic
species
(
fish
and
invertebrates),
EPA
requires
LC5O
studies
on
a
warm
water
species
(
preferably
bluegill
sunfish),
a
cold
water
species
(
preferably
rainbow
trout),
and
an
invertebrate
(
preferably
Daphnia
magna).
Toxicity
to
nontarget
mammals
is
initially
assessed
by
considering
LD5O
data
for
laboratory
rats,
which
EPA
requires
to
evaluate
pesticide
hazards
to
humans.
Typically,
EPA
requires
data
on
honeybees
to
address
the
risks
to
beneficial
insects.
In
situations
where
additional,
scientifically
valid,
toxicity
data
related
to
acute
effects
in
wildlife
and
aquatic
organisms
are
available
EFED
will
consider
them
in
establishing
the
toxicity
endpoint
for
risk
assessment.
It
is
EFED's
policy
to
conduct
risk
assessments
using
the
acute
lethal
endpoint
from
the
most
sensitive
species
tested.

The
acute
toxicity
data
described
above
are
basic
requirements
that
are
generally
available
for
all
pesticides
with
outdoor
uses.
For
some
kinds
of
pesticide
uses,
or
where
these
basic
data
warrant
additional
data,
EPA
may
require
higher
tier
testing.
Higher
tier
acute
data
may
include
toxicity
to
estuarine
fish,
invertebrates,
and
oyster
embryo
larvae;
and
oyster
shell
deposition
studies.
Chronic
toxicity
data
are
all
higher
tier
and
may
include
data
or
avian
reproductive
effects,
fish
early­
life
stage
toxicity,
chronic
toxicity
to
mammals
and
to
freshwater
fishes,
estuarine
fishes,
and
invertebrates.
The
chronic
toxicity
endpoints
commonly
considered
by
EFED
include
frank
effects
on
reproduction
such
as
numbers
of
offspring
produced
and
their
survival
as
well
a
growth
effects.
Rarely
are
data
from
field
studies,
aquatic
pond
studies,
or
secondary
toxicity
studies
available,
although
such
data
recently
have
been
required
for
some
pesticides.
The
EPA
validates
all
data
using
its
Standard
Evaluation
Procedures
(
Refs
2
through
24).

For
assessment
of
potential
effects
to
plants,
EFED
may
request
toxicity
data
regarding
seedling
emergence
and
vegetative
vigor
in
a
variety
of
terrestrial
plants
as
well
as
plant
growth
studies
for
aquatic
plants.
Effects
endpoints
for
terrestrial
plants
are
established
for
the
most
sensitive
tested
dicot
and
monocot
plants
and
are
set
at
the
no
observed
adverse
effect
concentration
(
NOAEC)
or
EC05
values
if
NOAEC
values
are
unavailable.

2.
Environmental
exposure.
Data
used
for
the
exposure
assessment
of
a
pesticide
include
(
1)
its
physical/
chemical
properties;
(
2)
environmental
fate
data,
including
data
on
persistence;
(
3)
Page
4
of
7
label
information
such
as
application
sites,
rates,
methods,
and
timing;
(
4)
bioconcentration;
and
(
5)
factors
related
to
the
species
themselves,
such
as
their
biology,
ecology,
and
distribution.
Occasionally,
field
residue
data
applicable
to
non­
target
species
are
available.

The
exposure
assessment
has
two
components.
The
first
component
is
the
determination
of
the
EECs
that
may
result
from
use
of
the
pesticide
according
to
label
directions.
The
second
is
a
determination
of
whether
non­
target
species
are
expected
to
be
exposed
to
the
EEC.

The
EPA
uses
various
models
to
determine
EECs
to
evaluate
the
risk
to
aquatic
species.
Whenever
possible.
actual
field
study
or
residue
data
also
are
reviewed.
The
models
used
include
(
a)
a
water
model,
(
b)
a
simple
drift
model,
(
c)
a
simple
runoff
model,
and
(
d)
a
computer
runoff
and
exposure
simulation
model.
Computer
based
models
include
the
Pesticide
Root
Zone
Model
coupled
with
the
Exposure
Analysis
Modeling
System
(
EXAMS).

To
determine
EECs
for
listed
terrestrial
species,
EPA
estimates
residues
on
food
items
consumed
by
the
species.
Estimated
residues,
primarily
on
plants
and
insects,
are
based
mainly
on
the
work
of
Hoerga
and
Kenaga
(
1972)
and
Fletcher
et
al.
(
1994).
These
works
are
a
compendium
of
measured
pesticide
residue
values
for
several
types
of
vegetable
material,
such
as
long
and
short
range
grasses;
leaves
and
leafy
crops;
forage
crops;
pods
containing
seeds;
and
fruit
(
cherries,
peaches,
grapes,
citrus).
Residues
are
given
on
the
basis
of
a
pesticide
application
rate
of
lb/
A
and
then
adjusted
for
the
label
rate.
The
estimates
represent
upper
bound
expected
residues
for
day
zero
(
immediately
after
application).
When
possible,
actual
validated
residue
data
also
are
considered.

In
estimating
the
environmental
concentrations,
EPA
also
considers
the
formulation
of
the
product,
such
as
liquid,
granular,
or
fumigant
formulations.
The
available
validated
pesticide
and
environmental
fate
data
are
used
in
the
computer
based
models
to
provide
more
accurate
assessments
from
multiple
applications,
as
identified
on
the
label.
Specific
scenarios
have
been
developed
for
runoff
from
specific
crop
sites,
as
well
as
environmental
concentrations
in
a
pond
or
headwater
stream
environment.
Data,
such
as
water
chemistry
data,
are
often
insufficient
to
accurately
run
the
more
sophisticated
computer
based
models.
The
EPA
is
attempting
to
develop
additional
scenarios
to
address
additional
use
sites,
different
application
methods
(
aerial,
ground,
etc.),
cropping
practices
(
no­
till,
strip
crop,
rotation,
etc.),
application
techniques
(
band,
infurrow
side­
dressing,
etc.),
and
integrated
pest
management
practices
so
that
alternatives
can
be
identified
that
will
protect
listed
species.

3.
Risk
assessment.
In
assessing
the
risk
to
non­
target
species
in
general,
EPA
compares
the
toxicity
information
with
the
EEC
and
then
determines
the
likelihood
that
non­
target
organisms
will
actually
be
exposed.
Comparisons
of
LC5O
or
LD50
values
with
EECs
indicate
whether
additional
data
may
be
required
or
that
a
particular
pesticide
may
warrant
restricted
use
classification
if
actual
exposure
may
occur.
When
evaluating
impacts
to
federally
listed
species,
EPA
does
not
rely
solely
on
the
LC5O
or
LD5O
end
points
since
some
listed
species
may
not
be
able
to
withstand
even
the
loss
of
a
few
individuals
in
the
population.
much
less
50
percent.
Page
5
of
7
Therefore,
more
stringent
criteria
have
been
developed
to
provide
greater
protection
for
populations
of
listed
species,
whose
numbers
in
many
instances
are
dangerously
low.
Thus,
criteria
were
developed
to
determine
the
environmental
concentrations
at
which
a
pesticide
A
"
may
affect"
a
listed
species.
These
criteria
were
developed
for
mammals,
birds,
and
aquatic
organisms
as
follows:

mammals
B
EEC
equal
to
or
greater
than
1/
5th
the
lowest
mammalian
acute
oral
LD1O
or
LC1O,
or
1/
10th
the
lowest
LD5O
or
LC5O;

birds
B
EEC
equal
to
or
greater
than
1/
5th
the
lowest
avian
acute
oral
LD1O
or
subacute
dietary
LC1O
or
1/
10th
the
lowest
LD5O
or
LC5O;
and
aquatic
organisms
B
EEC
equal
to
or
greater
than
1/
10th
the
lowest
aquatic
LC1O,
or
1/
20th
the
lowest
aquatic
LC5O.
Terrestrial
plant
criteria
are
set
at
an
EEC
equivalent
to
the
EC05
or
the
NOAEC,
depending
upon
toxicity
data
availability.

When
the
above
criteria
are
exceeded
for
any
relevant
taxa,
the
magnitude
of
the
potential
impact
is
determined
by
calculating
a
hazard
ratio,
which
is
the
ratio
of
the
EEC
(
based
on
a
specific
application
rate)
over
the
toxicity
criteria.
Any
hazard
ratio
of
one
or
greater
confirms
that
a
"
may
affect"
situation
exists,
since
the
predicted
residues
in
the
environment
are
equal
to
or
exceed
the
amount
of
the
pesticide
that
could
be
hazardous
to
the
species.
Higher
hazard
ratios
indicate
a
greater
magnitude
of
concern.

For
most
currently
registered
pesticides,
ecological
impacts
from
acute
toxicity
are
more
likely
than
those
from
chronic
toxicity.
However,
EPA
also
considers
information
related
to
subchronic
and
chronic
risks,
reproductive
effects,
and
bioaccumulation
factors.
The
laboratory
test
data
(
e.
g.,
chronic
feeding,
life
cycle,
oncogenicity,
or
reproductive
studies)
on
no­
effect
levels
or
no­
observable­
effect
levels
(
NOEL)
and/
or
effect
levels
are
compared
with
estimated
or
actual
field
residues.
When
these
residues
are
in
excess
of
the
NOEL
for
appropriate
surrogates
of
listed
species,
EPA
considers
there
is
a
potential
that
the
pesticide
may
affect
a
species
and
therefore,
conducts
more
in
depth
assessments.

Secondary
hazards
are
associated
with
acute
and
chronic
toxicity
relating
to
bioaccumulation
of
a
pesticide
in
the
food
chain
and
body
residues
of
target
or
non­
target
organisms
consumed
by
organisms
higher
in
the
food
chain.
Again,
estimated
or
actual
residues
In
food
items
are
correlated
with
diet
of
the
non­
target
organisms
and
compared
with
the
acute
and
chronic
toxicity
values.

In
evaluating
the
risk
from
pesticide
use,
EPA
also
considers
other
information.
For
example,
toxicity
to
non­
target
insects,
such
as
honey
bees,
is
important
because
pollination
can
be
critical
to
certain
listed
plants.
Any
reports
of
pesticide
incidents
involving
non­
target
species,
even
if
they
are
not
listed
species,
also
are
considered.
Page
6
of
7
Finally,
effects
on
listed
species

habitats
and
food
supply
are
also
considered.
For
example,
the
Everglade
snail
kite
feeds
specifically
on
the
apple
snail.
Therefore,
any
disruption
of
the
apple
snail's
habitat
from
pesticides
or
pesticide
toxicity
to
the
apple
snail
itself
may
adversely
affect
the
Everglade
snail
kite.
Also,
herbicide
disruptions
of
animal
and
plant
community
balance
also
could
adversely
impact
the
habitat
or
micro­
habitat
of
listed
species.
For
example,
herbicides
are
unlikely
to
be
directly
toxic
to
the
valley
elderberry
longhorn
beetle,
but
they
may
destroy
the
elderberry
trees
in
which
the
beetle
lives.
On
occasion,
pesticide
use
may
be
beneficial
to
some
species

habitats
by
reversing
adverse
plant
competition
trends
that
have
been
exacerbated
by
other
human
activities,
such
as
exotic
introductions
and
wildfire
control.

When
all
the
data
are
evaluated,
if
a
"
may
affect
determination"
is
made,
EPA
assembles
all
of
the
relevant
information
and/
or
references,
along
with
any
reasonable
and
prudent
alternatives
that
are
known,
and
sends
it
to
FWS
requesting
consultation,
per
the
Services
regulations.
The
species
and
pesticides
included
in
this
request
are
only
those
where
a
"
may
affect
determination"
was
made.

Following
receipt
of
the
request
for
consultation,
FWS
prepares
the
Biological
Opinion
and
determines
if
the
use
is
likely
to
pose
jeopardy
to
the
continued
existence
of
a
species,
if
the
use
will
result
in
the
destruction
or
adverse
modification
of
critical
habitat
of
a
species
or
if
incidental
take
is
anticipated
and
provisions
are
necessary
to
minimize
these
impacts.
A
"
may
affect
determination"
by
EPA
may
not
result
in
a
jeopardy
determination
by
FWS
or
result
in
any
anticipated
incidental
take.

C.
Threshold
Application
Rate
Estimates
Some
pesticides
(
e.
g.,
certain
ones
that
have
been
subject
to
Special
Review)
have
been
evaluated
enough

that
the
application
rates
that
would
result
in
a
"
may
affect"
determination
are
already
known.
For
other
pesticides,
EPA
will
first
screen
them
to
determine
if
the
highest
application
rate
would
result
in
a
"
may
affect"
determination.
Pesticides
that
do
not
exceed
the
"
may
affect"
criteria
are
dropped
from
further
analysis.
For
pesticides
that
do
exceed
the
criteria
at
the
highest
application
rate,
EPA
then
will
determine
the
EEC
that
would
result
from
an
application
rate
of
1
pound
active
ingredient
per
acre
(
lb
ai/
A)
for
various
combinations
of
application
methods
and
formulation
types
(
and
environments,
where
appropriate)
of
a
pesticide.
Typically,
EPA
then
will
compare
the
resulting
EEC

s
to
toxicity
to
obtain
a
hazard
ratio.

A
hazard
ratio
of
"
1"
or
greater
indicates
that
the
EEC
has
met
or
exceeded
our
"
may
affect"
criteria.
If
using
1
lb
ai/
A
application
rate
results
In
a
hazard
ratio
of
less
than
one
(
indicating
the
"
may
affect"
criteria
has
not
been
met
at
that
rate),
the
ratio
allows
EPA
to
calculate
the
highest
application
rate
that
would
still
not
result
in
a
"
may
affect"
determination,
which
may
be
compared
with
product
label
rates.

This
is
accomplished
by
multiplying
the
1
lb
ai/
A
application
rate
by
the
reciprocal
of
the
hazard
ratio.
For
example,
if
the
hazard
ratio
is
1/
5
based
on
a
1
lb
ai/
A
application
rate,
the
Page
7
of
7
application
rate
which
would
result
in
a
"
may
affect"
determination
would
be
1
lb
ai/
A
x
5/
1
or
5
lb
ai/
A.
The
same
procedure
applies
even
if
the
hazard
ratio
is
greater
than
1.
However,
the
application
rate
derived
in
the
latter
case
might
not
be
a
rate
specified
on
the
label,
in
which
case
all
label
use
rates
would
result
in
a
"
may
affect"
to
listed
species.

U.
S.
Environmental
Protection
Agency.
1986.
Hazard
Evaluation
Division
Standard
Evaluation
Procedure,
Ecological
Risk
Assessment
Fletcher,
J.
S.,
J.
E.
Nellesson
and
T.
G.
Pfleeger.
1994.
Literature
Review
and
Evaluation
of
the
EPA
Food­
Chain
(
Kenaga)
Nomogram,
an
Instrument
for
Estimating
Pesticide
Residues
on
Plants.
Environ.
Tox.
and
Chem.
13(
9):
1383­
1391.
Hoerger,
F.
and
E.
E.
Kenaga.
1972.
Pesticide
Residues
on
Plants:
Correlation
of
Representative
Data
as
a
Basis
for
Estimation
of
Their
Magnitude
in
the
Environment.
IN:
F.
Coulston
and
F.
Corte,
eds.,
Environmental
Quality
and
Safety:
Chemistry,
Toxicology,
and
Technology.
Vol
I.
Georg
Thieme
Publishers,
Stuttgart,
West
Germany,
pp.
9­
28.