XV
­
1
Appendix
XIV.

COMPARISON
OF
OW
AND
OPP
METHODS
FOR
AQUATIC
ASSESSMENTS
CATEGORY
OW
OPP
APPROACH
USED
TO
ESTABLISH
LEVEL
OF
PROTECTION
Establishes
numerical
ambient
water
quality
criteria
only
if
all
required
data
are
available.
Develops
a
Criterion
Continuous
Concentration
(
CCC)
and
a
Criterion
Maximum
Concentration
(
CMC)
which
are
concentrations
that
should
not
result
in
unacceptable
effects
of
aquatic
organisms
and
their
uses.
Except
possibly
where
a
locally
important
species
is
very
sensitive,
aquatic
organisms
and
their
uses
should
not
be
affected
unacceptably
if
the
fourday
average
concentration
of
a
chemical
does
not
exceed
the
CCC
more
than
once
every
three
years
on
the
average
and
if
the
one­
hour
average
concentration
does
not
exceed
the
CMC
more
than
once
every
three
years.
Uses
"
Quotient
Method",
whereby
an
Estimated
Environmental
Concentration
(
EEC)
is
compared
to
an
effect
level,
usually
an
LC50
for
acute
effects
and
an
NOAEC
for
chronic
effects.
The
resulting
ratio
of
EEC
to
effect
level,
also
referred
to
as
the
Risk
Quotient
(
RQ),
is
compared
to
a
Level
of
Concern
(
LOC).

EECs
are
developed
from
Tier
I
or
Tier
2
surface
water
models.
The
Tier
1
model,
GENEEC,
estimates
surface
water
concentrations
from
both
runoff
and
spray
drift
from
a
10­
hectare
field
immediately
adjacent
to
a
1­
hectare
pond
that
is
2
meters
deep
and
has
no
outlet.
The
contribution
of
pesticide
is
based
on
a
single
application
of
pesticide
followed
by
a
storm
event
that
causes
10
percent
runoff
of
the
applied
pesticide
into
the
adjacent
pond.
The
contribution
of
pesticide
from
spray
drift,
however,
is
estimated
based
on
spray
drift
that
is
associated
with
each
application
of
pesticide.
Data
on
fate
processes
such
as
hydrolysis
in
water,
photolysis
in
soil,
aerobic
soil
metabolism,
aerobic
aquatic
metabolism,
and
sorption
of
pesticide
onto
soil
are
accounted
for
in
estimating
surface
water
concentrations.

If
RQ
values
based
on
EECs
estimated
from
GENEEC
exceed
LOCs,
EECs
are
subsequently
estimated
from
a
Tier
2
model,
PRZM/
EXAMS,
which
includes
more
detailed
information
on
crop
site
characteristics
than
GENEEC.
For
each
crop
for
which
pesticide
application
is
proposed,
PRZM/
EXAMs
includes
a
single
location
to
represent
a
typical
upper­
end
scenario.
Generally,
weather
and
agricultural
practices
are
simulated
over
36
years
so
that
the
1
in
10
year
annual
return
frequency
at
the
representative
location
can
be
estimated.
This
annual
return
frequency
corresponds
to
the
90th
percentile
annual
exceedance
that
was
determined
over
the
36­
year
period
that
was
modeled.
The
90th
percentile
annual
exceedance
is
determined
by
ranking
from
highest
to
lowest
the
dissolved
water
column
concentrations
for
each
of
the
36
years
modeled
and
determining
the
90th
percentile
of
these
values.
The
EEC
can
also
be
based
on
monitoring
data,
if
available.
CATEGORY
OW
OPP
XV
­
2
DERIVATION
OF
LEVELS
OF
PROTECTION
The
CMC
is
an
estimate
of
the
concentration
of
material
corresponding
to
a
cumulative
probability
of
0.05
in
the
acute
toxicity
values
for
the
genera
with
which
acceptable
acute
tests
have
been
conducted
on
the
material.
The
CMC
is
intended
to
protect
95
percent
of
a
group
of
diverse
genera,
unless
a
commercially
or
recreationally
important
species
is
very
sensitive.
The
Criterion
Maximum
Concentration
(
CMC)
is
based
on
one­
half
the
final
acute
values
for
fresh
and
salt
water.
The
Final
Acute
Value
is
derived
from
Genus
Mean
Acute
Values,
the
geometric
means
of
all
the
Species
Mean
Acute
Values
for
species
in
the
genus.
The
Criterion
Continuous
Concentration
(
CCC)
is
intended
to
be
a
good
estimate
of
a
threshold
of
unacceptable
effect,
not
a
threshold
of
adverse
effect.
The
CCC
is
equal
to
the
lowest
of
the
Final
Chronic
Value,
the
Final
Plant
Value,
and
the
Final
Residue
Value,
unless
other
available
data
concerning
adverse
effects
on
aquatic
organisms
and
their
uses
show
that
a
lower
value
should
be
used.
The
Final
Chronic
Value
might
be
calculated
in
the
same
manner
as
the
Final
Acute
Value
or
by
dividing
the
Final
Acute
Value
by
the
Final
Acute­
Chronic
Ratio.
A
chronic
value
may
be
obtained
by
calculating
the
geometric
mean
of
the
lower
and
upper
chronic
limits
from
a
chronic
test
or
by
analyzing
chronic
data
using
regression
analysis.
The
Final
Plant
Value
should
be
obtained
by
selecting
the
lowest
result
from
a
test
with
an
important
aquatic
plant
species
in
which
the
concentration
of
test
material
was
measured
and
the
endpoint
was
biologically
important.
The
Final
Residue
Value
is
the
lowest
of
the
residue
values
that
are
obtained
by
dividing
maximum
permissible
tissue
concentrations
by
appropriate
bioconcentration
or
bioaccumulation
factors.
A
maximum
permissible
tissue
concentration
is
either
an
FDA
action
level
for
fish
oil
or
the
edible
portion
of
fish
or
shellfish,
or
a
maximum
acceptable
dietary
intake
based
on
observations
of
survival,
growth,
or
reproduction
in
a
chronic
wildlife
feeding
study
or
a
long­
term
wildlife
field
study.
In
addition,
if
appropriate,
the
CCC
and
CMC
are
also
related
to
a
water
quality
characteristic,
such
as
pH,
salinity,
or
hardness.
In
many
situations,
states
might
want
to
adjust
water
quality
criteria
to
reflect
local
environmental
conditions,
ecologically
important
species,
and
human
exposure
patterns.
To
assess
acute
risk
to
fish
and
aquatic
invertebrates,
use
the
lowest
LC50
or
EC50
value
for
each
ecosystem
and
aquatic
organism
(
i.
e.,
freshwater
and/
or
estuarine/
marine
fish
and
aquatic
invertebrate)
and
compare
the
aquatic
peak
EEC
with
the
LC50
or
EC50
value.
If
the
resulting
risk
quotient
is
greater
than
a
Level
of
Concern
(
LOC)
of
0.5,
then
there
is
potential
for
acute
risk
to
aquatic
fish
and
invertebrates
from
use
of
the
pesticide.
If
the
resulting
risk
quotient
is
greater
than
an
LOC
of
0.1,
but
less
than
an
LOC
of
0.5,
then
risk
to
fish
and
aquatic
invertebrates
is
presumed
that
may
be
mitigated
by
precautionary
labeling
statements
or
through
labeled
use
restrictions.
If
the
resulting
risk
quotient
is
less
than
an
LOC
of
0.1,
but
greater
than
an
LOC
of
0.05,
then
there
is
potential
for
risk
to
endangered
aquatic
fish
and
invertebrates.

To
assess
chronic
risk
to
aquatic
fish
and
invertebrates,
use
the
No
Observed
Adverse
Effect
Level
(
NOAEL)
from
the
fish
early
lifestage
or
fish
full
life­
cycle
tests
and
the
aquatic
invertebrate
early
life­
cycle
test.
Compare
the
NOAEL
for
aquatic
fish
with
the
56­
day
average
EEC
and
the
NOAEL
for
aquatic
invertebrates
with
the
21­
day
average
EEC.
If
the
resulting
RQ
is
greater
than
an
LOC
of
1.0,
then
there
is
potential
for
chronic
risks
to
these
aquatic
animals.

To
assess
acute
risk
to
aquatic
plants,
use
the
lowest
EC50
or
NOAEC
from
Tier
1
or
Tier
2
aquatic
plant
growth
tests
on
five
aquatic
plant
species.
Compare
this
endpoint
with
the
EEC
derived
from
Tier
1
or
Tier
2
surface
water
modeling,
as
needed.
If
the
resulting
RQ
is
greater
than
an
LOC
of
1.0,
then
there
is
potential
for
acute
risk
to
aquatic
plants.
To
assess
acute
risk
to
endangered
aquatic
plants,
use
the
lowest
LC50
from
aquatic
plant
growth
tests
on
5
aquatic
plants.
Compare
this
endpoint
with
the
aquatic
plant
EEC.
If
the
resulting
RQ
is
greater
than
an
LOC
of
1.0,
then
there
is
potential
for
acute
risk
to
endangered
aquatic
plants.
CATEGORY
OW
OPP
XV
­
3
MINIMUM
DATA
REQUIRED
TO
ESTABLISH
LEVEL
OF
PROTECTION
To
derive
a
criterion
for
freshwater
aquatic
organisms
and
their
uses,
the
following
should
be
available:
(
1)
Results
of
acceptable
acute
tests
with
at
least
one
species
of
freshwater
animal
in
at
least
eight
different
families
such
that
all
of
the
following
are
included:
the
family
Salmonidae
in
the
class
Osteichthyes;
a
second
family
in
the
class
Osteichthyes,
preferably
a
commercially
or
recreationally
important
warmwater
species
(
i.
e.,
bluegill,
channel
catfish,
etc.);
a
third
family
in
the
phylum
Chordata
(
may
be
in
the
class
Osteichthyes
or
may
be
an
amphibian,
etc.);
a
planktonic
crustacean
(
e.
g.,
cladoceran,
copepod,
etc.);
a
benthic
crustacean
(
e.
g.,
ostracod,
isopod,
amphipod,
crayfish,
etc.);
an
insect
(
e.
g.,
mayfly,
dragonfly,
damselfly,
stonefly,
caddisfly,
mosquito,
midge,
etc.);
a
family
in
a
phylum
other
than
Arthropoda
or
Chordata
(
e.
g.,
Rotifera,
Annelida,
Mollusca,
etc.);
a
family
in
any
order
of
insect
or
any
phylum
not
represented.
(
2)
Acute­
chronic
ratios
with
species
of
aquatic
animals
in
at
least
three
different
families
provided
that
of
the
three
species:
at
least
one
is
a
fish;
at
least
one
is
an
invertebrate;
at
least
one
is
an
acutely
sensitive
freshwater
species
(
the
other
two
may
be
saltwater
species).
(
3)
Results
of
at
least
one
acceptable
test
with
a
freshwater
alga
or
vascular
plant.
(
4)
At
least
one
acceptable
bioconcentration
factor
determined
with
an
appropriate
freshwater
species,
if
a
maximum
permissible
tissue
concentration
is
availble.
Examines
the
potential
risks
of
the
proposed
pesticide
uses
to
non­
target
fish
and
aquatic
invertebrates
in
the
freshwater
and
in
the
estuarine/
marine
environments
if
there
is
potential
for
pesticide
to
be
used
in
these
environments.
Examines
risks
to
non­
target
algae
and
aquatic
plants
when
pesticide
is
an
herbicide
or
fungicide.
Aquatic
toxicity
test
data
required
and
associated
indicator
species
include:
(
1)
acute
96­
hour
toxicity
test
for
freshwater
fish
­
coldwater
fish
is
the
rainbow
trout
(
Salmo
gairdneri)
and
warmwater
fish
is
the
bluegill
sunfish
(
Lepomis
macrochirus);
(
2)
acute
96­
hour
toxicity
test
for
freshwater
invertebrates
­
water
flea
(
Daphnia
magna);
(
3)
acute
96­
hour
toxicity
test
for
estuarine
and
marine
fish
­
sheepshead
minnow
(
Cyprinodon
variegatus);
(
4)
acute
96­
hour
toxicity
test
for
estuarine
and
marine
crustacean
­
mysid,
penaeid,
or
grass
shrimp;
(
5)
acute
toxicity
for
estuarine
and
marine
mollusc
­
96­
hour
flowthrough
shell
deposition
and
48­
hour
embryolarvae
studies
on
Eastern
oyster
(
Crassostrea
virginica);
(
6),
(
7)
chronic
fish
early­
life
stage
and
fish
full
life­
cycle
studies
on
rainbow
trout
(
Salmo
gairdneri)
or
brook
trout
(
Salvelinus
fontinalis)
and
fathead
minnow
(
Pimephales
promelas);
(
8)
aquatic
invertebrate
life­
cycle
­
water
flea,
(
Daphnia
magna);
(
9)
fish
bioaccumulation
factor.

Aquatic
plant
testing
is
required
for
all
pesticides
used
outdoors.
Tier
1
testing
is
to
be
performed
on
5
aquatic
plant
species
at
the
maximum
proposed
application
rate
on
the
pesticide
label.
The
5
aquatic
plants
to
be
tested
in
Tier
1include:
duckweed
(
Lemna
gibba);
marine
diatom
(
Skeletonema
costatum);
bluegreen
alga
(
Anabaena
flos­
aquae);
freshwater
green
alga
(
Selenastrum
capricornutum);
and
freshwater
diatom
(
unspecified
species).
The
substance
to
be
tested
is
the
Typical
End
Use
Product
(
TEP)
rather
than
the
Technical
Grade
Active
Ingredient
(
TGAI).
For
any
aquatic
plant
species
exhibiting
phytotoxic
effects
from
Tier
1
testing,
a
Tier
2
test
must
be
performed.
Tier
2
testing
is
performed
at
dose
rates
less
than
the
maximum
label
rate.
CATEGORY
OW
OPP
XV
­
4
SOURCE
AND
TYPE
OF
DATA
COLLECTED
Collects
all
available
data
on
the
chemical
concerning
toxicity
to,
and
bioaccumulation
by,
aquatic
animals
and
plants;
FDA
action
levels;
chronic
feeding
studies
and
long­
term
field
studies
with
wildlife
species
that
regularly
consume
aquatic
organisms.
Under
FIFRA,
the
Agency
is
not
responsible
for
producing
the
data
needed
to
assess
ecological
risks.
That
burden
is
placed
upon
the
applicants
for
pesticide
registration.
OPP
requests
certain
toxicity
data
prior
to
performing
an
aquatic
risk
assessment.
The
following
aquatic
toxicological
hazard
data
represent
the
full
complement
of
aquatic
testing
that
could
be
requested
for
an
aquatic
risk
assessment:
Tier
1
­
96­
hour
coldwater
fish
LC50;
96­
hour
warmwater
fish
LC50;
48­
hour
(
or
96­
hour)
freshwater
aquatic
invertebrate
LC50.
Tier
2
­
96­
hour
estuarine/
marine
fish
LC50;
96­
hour
estuarine/
marine
fish
LC50;
48­
hour
oyster
embryo­
larvae
EC50;
96­
hour
oyster
shell
deposition
EC50;
fish
early
life­
stage
No
Observed
Adverse
Effect
Level
(
NOAEL);
aquatic
invertebrate
life­
cycle
NOAEL;
fish
bioaccumulation
factor;
and
fish
acetylcholinesterase
levels.
Tier
3
­
fish
full
life­
cycle
NOAEL.
Tier
4
­
fish/
aquatic
invertebrate
population
effects
in
the
field;
simulated
and
actual
field
effects
data
on
aquatic
organisms.

Registrants
are
also
required
to
provide
data
on
the
fate
and
transport
of
pesticides
in
the
environment.
These
fate
data
requirements
include:
hydrolysis,
photodegradation
in
water,
photodegradation
in
soil,
aerobic
soil
metabolism,
anaerobic
soil
metabolism,
anaerobic
aquatic
metabolism,
and
aerobic
aquatic
metabolism,
leaching
and
adsorption/
desorption,
and
aquatic
field
dissipation.
CATEGORY
OW
OPP
XV
­
5
GENERAL
CRITERIA
FOR
ACCEPTABLE
STUDIES
Some
general
criteria
are
included
in
"
Guidelines
for
Deriving
Numerical
National
Water
Quality
Criteria
for
the
Protection
of
Aquatic
Organisms
and
Their
Uses".
These
general
criteria
include:
(
1)
All
data
that
are
used
should
be
available
in
typed,
dated,
and
signed
hard
copy
with
enough
supporting
information
to
indicate
that
acceptable
test
procedures
were
used
and
that
the
results
are
probably
reliable.
(
2)
In
some
cases
it
may
be
appropriate
to
obtain
additional
written
information
from
the
investigator,
if
possible.
(
3)
Data
on
technical
grade
material
may
be
used
if
appropriate,
but
data
on
formulated
mixtures
and
emulsifiable
concentrates
of
the
material
of
concern
should
not
be
used.
(
4)
For
some
highly
volatile,
hydrolyzable,
or
degradable
materials
it
is
probably
appropriate
to
use
only
results
of
flow­
through
tests
in
which
the
concentrations
of
test
material
in
the
test
solutions
were
measured
often
enough
using
acceptable
analytical
methods.
(
5)
Questionable
data,
data
on
formulated
mixtures
and
emulsifiable
concentrates,
and
data
obtained
with
non­
resident
species
or
previously
exposed
organisms
may
be
used
to
provide
auxiliary
information
but
may
not
be
used
in
the
derivation
of
criteria.
To
be
determined
as
acceptable,
or
Core,
studies
must
meet
Subdivision
E
guidelines.
OPP
has
published
regulations
which
specify
the
data
that
are
required
for
registration
(
i.
e.,
40
CFR
part
158),
and
guidelines
which
provide
recommended
testing
methods
that
are
needed
to
produce
the
required
data
(
i.
e.,
Pesticide
Assessment
Guidelines
­
Subdivision
E).
In
addition,
Standard
Evaluation
Procedures
(
SEPs)
have
been
developed
for
each
type
of
data
that
is
required
for
an
ecological
risk
assessment.
These
SEPs
explain
the
procedure
used
to
evaluate
ecological
effects
data
submitted
to
OPP,
and
ensure
comprehensive
and
consistent
treatment
of
the
science
in
reviews
as
well
as
providing
interpretive
policy
guidance.
These
SEPs
are
published
and
are
available
through
the
National
Technical
Information
Service
(
NTIS).

Specific
Standard
Evaluation
Procedure
documents
for
aquatic
organism
tests
include:

(
1)
Ecological
Risk
Assessment
­
EPA­
540/
9­
85­
001;
(
2)
Acute
Toxicity
Test
for
Freshwater
Fish
­
EPA­
540/
9­
85­
006;
(
3)
Acute
Toxicity
for
Freshwater
Invertebrates
­
EPA­
540/
9­
85­
005;
(
4)
Acute
Toxicity
Test
for
Estuarine
and
Marine
Organisms
(
Shrimp
96­
Hour
Acute
Toxicity
Test)
­
EPA­
540/
9­
85­
010;
(
5)
Acute
Toxicity
Test
for
Estuarine
and
Marine
Organisms
(
Estuarine
Fish
96­
Hour
Acute
Toxicity
Test)
­
EPA­
540/
9­
85­
009;
(
6)
Acute
Toxicity
Test
for
Estuarine
and
Marine
Organisms
(
Mollusc
96­
Hour
Flow­
Through
Shell
Deposition
Study)
­
EPA­
540/
9­
85­
011;
(
7)
Non­
Target
Plants:
Growth
and
Reproduction
of
Aquatic
Plants
­
Tiers
1
and
2
­
EPA­
540/
9­
86­
134;
(
8)
Fish
Early
Life­
Stage
­
EPA
540/
9­
86­
138;
(
9)
Daphnia
magna
Life­
Cycle
(
21­
Day
Renewal)
Chronic
Toxicity
Test
­
EPA
540/
9­
86­
141;
and
(
10)
Fish
Life­
Cycle
Toxicity
Tests
­
EPA
540/
9­
86­
137.
