Page
1
of
26
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
Date:
09/
27/
05
MEMORANDUM
SUBJECT:
Aquashade:
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
FROM:
Wade
Britton,
Industrial
Hygienist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)

THROUGH:
Catherine
Eiden,
Branch
Chief
Reregistration
Branch
3
Health
Effects
Division
(
7509C)

TO:
Kendra
Tyler,
CRM
Reregistration
Branch
1
SRRD
(
7508C)

DP
Barcode:
321915
Pesticide
Chemical
Codes:
110301,
110302,
110303
Page
2
of
26
TABLE
OF
CONTENTS
1.0
Occupational
and
Residential
Exposure
Assessment
for
Aquashade
.....................................
4
1.1
Purpose
...................................................................................................................
5
1.2
Summary
of
Hazard
Concerns
for
Aquashade
..........................................................
5
1.4
Incident
Reports
......................................................................................................
8
1.5
Summary
of
Use
Patterns
and
Formulations
.............................................................
8
1.5.1
End
Use
Products......................................................................................
8
1.5.2
Registered
Use
Categories
and
Sites..........................................................
9
1.5.3
Application
Methods
...............................................................................
10
2.0
Occupational
Exposures
and
Risks
....................................................................................
10
2.1
Occupational
Handler
Exposures
and
Risks............................................................
10
2.1.1
Data
and
Assumptions
for
Handler
Exposure
Scenarios
...........................
11
2.1.1.1
Assumptions
for
Handler
Exposure
Scenarios
...........................
11
2.1.1.2
Exposure
Data
for
Handler
Exposure
Scenarios
........................
12
2.1.2
Aquashade
Handler
Exposure
Scenarios
..................................................
14
2.1.3
Non­
cancer
Aquashade
Handler
Exposure
and
Assessment......................
14
2.1.3.1
Non­
cancer
Aquashade
Handler
Exposure
and
Risk
Calculations
................................................................................
14
2.1.3.2
Aquashade
Non­
cancer
Risk
Summary
(
using
PHED
data)........
16
2.1.4
Cancer
Aquashade
Handler
Exposure
and
Risk
Assessment
.....................
18
2.1.5
Summary
of
Risk
Concerns
and
Data
Gaps
for
Occupational
Handlers....
18
2.1.5.1
Summary
of
Risk
Concerns
.......................................................
18
2.1.5.2
Summary
of
Data
Gaps
.............................................................
18
2.1.6
Recommendations
for
Refining
Occupational
Handler
Risk
Assessment
...
18
2.2
Occupational
Postapplication
Exposures
and
Risks
................................................
19
3.0
Residential
and
Other
Non­
Occupational
Exposures
and
Risks
..........................................
19
3.1
Residential
Handler
Exposures
and
Risks
...............................................................
20
3.2
Residential
Postapplication
Exposures
and
Risks....................................................
24
3.2.1
Residential
Postapplication
Exposure
Scenarios.......................................
24
3.2.2
Data
and
Assumptions
for
Residential
Postapplication
Exposure
Scenarios
                             
25
3.2.3
Residential
Postapplication
Exposure
and
Noncancer
Risk
Estimates
.......
25
3.2.4
Residential
Postapplication
Exposure
and
Risk
Estimates
for
Cancer....................................................................................................
26
3.2.5
Recommendations
for
Refining
Residential
Postapplication
Risk
Assessments
...........................................................................................
26
Page
3
of
26
Executive
Summary
A
combination
of
erioglaucine
(
Acid
Blue
9
or
FD&
C
Blue
No.
1)
and
tartrazine
(
Acid
Yellow
23
or
FD&
C
Yellow
No.
5)
is
commonly
referred
to
as
Aquashade.
The
two
dyes
work
by
controlling
the
portion
of
the
light
spectrum
required
for
photosynthesis,
thereby
limiting
the
growth
of
filamentous
algae
and
submerged
aquatic
vegetation.
Registered
use
sites
for
aquashade
include
aquatic
uses
only.
Aquashade
is
registered
for
use
in
occupational
and
residential
settings.

Hazard
Concerns:

Use
Patterns:
Aquashade
is
registered
for
use
as
an
aquatic
algaecide/
herbicide.
Application
is
recommended
early
in
the
growing
season
while
growth
is
on
the
bottom
of
the
water
body
or
later
in
the
season
after
the
killing
and/
or
removal
of
any
existent
growth.
Repeated
applications
are
allowed
to
maintain
an
effective
concentration
of
product
in
the
water
body.
Aquashade
may
be
used
in
natural
or
manmade
ponds,
lakes,
fountains,
fish
farms
and
fish
hatcheries;
and
may
be
applied
by
both
professional
applicators
and
homeowners
(
Admiral
Liquid;
EPA
Reg.
No.
67064­
2
 
approved
3/
24/
05).
HED
does
not
have
chemical
specific
data
for
Aquashade
application
methods,
therefore
estimates
were
based
on
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF).

Occupational
Handler
Risks:
Pesticide
handler
exposure
to
Aquashade
is
likely
to
occur
during
its
use
in
a
variety
of
occupational
environments.
The
anticipated
use
patterns
and
current
labeling
indicate
several
occupational
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
be
potentially
used
for
Aquashade
applications.
Short­
term
(
1
to
30
days)
and
intermediate­
term
exposures
(
1
to
6
months)
may
occur;
however,
long­
term
exposures
(
greater
than
6
months)
are
not
expected.

All
short­
and
intermediate­
term
occupational
scenarios
assessed
(
dermal
and
inhalation)
resulted
in
estimated
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
Short­
and
intermediateterm
dermal
MOEs
range
from
410
(
Liquids
for
Pouring
Applications)
to
4,300
(
Liquids
for
Garden
Hose­
End
Sprayer),
and
short­
and
intermediate­
term
inhalation
MOEs
range
from
120,000
(
Liquids
for
Garden
Hose
End
Sprayer)
to
1,600,000
(
Liquids
for
Pouring
Applications).

Occupational
Postapplication
Risks:
Since
Aquashade
is
an
algaecide/
herbicide,
HED
is
not
aware
of
any
postapplication
activities
which
may
result
in
exposure.
No
harvesting
is
required,
and
while
scouting
may
include
identifying
any
algae
or
aquatic
weed
regrowth,
these
activities
should
not
require
contact
with
the
treated
water
body.
For
these
reasons,
occupational
postapplication
exposure
of
workers
to
previously
treated
water
bodies
is
expected
to
be
negligible
and
was
not
assessed.
Furthermore,
any
postapplication
activities
that
could
potentially
occur
would
not
be
expected
to
exceed
those
assessed
from
residential
exposures
to
Aquashade
which
are
not
of
concern.
Residential
Handler/
Postapplication
Risks:
Aquashade
is
labeled
for
consumer
use
to
control
Page
4
of
26
aquatic
algae
and
weeds
in
ponds
and
lakes.
The
anticipated
use
patterns
and
current
labeling
indicate
several
residential
handler
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
to
make
Aquashade
applications.
Residents
or
consumers
applying
Aquashade
products
to
ponds
or
lakes
may
be
exposed
for
short­
term
(
1
to
30
days)
duration
through
skin
contact
or
by
inhalation.

All
residential
handler
scenarios
assessed
(
dermal
and
inhalation)
resulted
in
estimated
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
Residential
short­
term
dermal
MOEs
range
from
1,930
(
Liquids
for
Pouring
Applications)
to
16,000
(
Liquids
for
LCO
Handgun),
and
shortterm
inhalation
MOEs
range
from
550,000
(
Liquids
for
Garden
Hose
End
Sprayer)
to
6,600,000
(
Liquids
for
Pouring
Applications).

Postapplication
exposures
to
children
and
adults
that
contact
Aquashade­
treated
swimming
ponds
are
anticipated.
To
address
the
risk
of
such
exposures,
a
screening
tool
called
the
Swimmer
Exposure
Assessment
Model
(
SWIMODEL)
was
applied.
The
SWIMODEL
uses
well­
accepted
screening
exposure
assessment
equations
to
calculate
the
total
worst­
case
exposure
for
swimmers
expressed
as
a
mass­
based
intake
value
(
mg/
event).
Postapplication
residential
exposure
durations
are
expected
to
be
short­
and
intermediate­
term
(
1
to
6
months)
in
duration.
All
residential
postapplication
scenarios
assessed
(
dermal,
ingestion,
aural,
buccal/
sublingual,
and
nasal/
orbital
routes
of
exposure)
resulted
in
estimated
combined
MOEs
well
above
100
and,
therefore,
are
not
of
concern.

To
better
quantify
residential
Aquashade
hazard,
results
from
residential
handler
and
residential
postapplication
(
i.
e.,
swimmer)
risk
assessments
were
aggregated.
Aggregate
calculations
of
residential
exposure
were
performed
using
worst­
case
MOEs
resulting
from
each
assessment.

The
residential
aggregated
exposure
resulted
in
an
estimated
MOE
of
1700
and,
therefore,
is
not
a
risk
of
concern.

1.0
Occupational
and
Residential
Exposure
Assessment
for
Aquashade
Page
5
of
26
1.1
Purpose
This
document
is
the
occupational
and
residential
non­
dietary
exposure
and
risk
assessment
for
Aquashade
from
its
use
as
an
algaecide/
herbicide.
In
this
document,
which
is
for
use
in
EPA=
s
development
of
the
HED
chapter
of
the
Aquashade
RED
Document,
EPA
presents
the
results
of
its
review
of
the
potential
human
health
effects
of
occupational
exposure
to
Aquashade.

1.2
Criteria
for
Conducting
Exposure
Assessments
An
occupational
and/
or
residential
exposure
assessment
is
required
for
an
active
ingredient
if
(
1)
certain
toxicological
criteria
are
triggered
and
(
2)
there
is
a
potential
for
exposure
to
handlers
(
mixers,
loaders,
applicators)
during
use
or
to
persons
entering
treated
sites
or
exposed
to
vapors
after
application
is
complete.
Toxicological
endpoints
were
selected
for
short­
and
intermediateterm
dermal
and
inhalation
exposures
to
Aquashade.
There
is
a
significant
potential
for
exposure
in
a
variety
of
occupational
agricultural
settings.
Therefore,
a
risk
assessment
is
required
for
occupational
exposures
that
can
occur
as
a
result
of
Aquashade
use.

1.3
Summary
of
Hazard
Concerns
for
Aquashade
Dermal
Route
(
non­
cancer):
For
short­
and
intermediate­
term
dermal
exposures
to
Aquashade,
an
endpoint
was
selected
based
upon
co­
critical
studies,
a
chronic
oral
toxicity
study
in
dogs
with
tartrazine
and
chronic
oral
toxicity/
carcinogenicity
study
in
rats
with
erioglaucine.
The
dermal
endpoint
was
assigned
considering
the
most
protective
NOAEL
resulting
from
the
two
studies,
500
mg/
kg/
day;
as
determined
from
the
chronic
oral
toxicity
dog
study
with
tartrazine.
The
resulting
NOAEL
was
the
highest
dose
tested
(
HDT)
in
the
selected
study.

Inhalation
Route
(
non­
cancer):
For
short­
and
intermediate­
term
inhalation
exposures
to
Aquashade,
an
endpoint
was
selected
based
upon
co­
critical
studies,
a
chronic
oral
toxicity
study
in
dogs
with
tartrazine
and
chronic
oral
toxicity/
carcinogenicity
study
in
rats
with
erioglaucine.
The
inhalation
endpoint
was
assigned
considering
the
most
protective
NOAEL
resulting
from
the
two
studies,
500
mg/
kg/
day;
as
determined
from
the
chronic
oral
toxicity
dog
study
with
tartrazine.
The
resulting
NOAEL
was
the
highest
dose
tested
(
HDT)
in
the
selected
study.

Incidental
Oral
(
non­
cancer):
For
short­
and
intermediate­
term
incidental
oral
exposures
to
Aquashade,
an
endpoint
was
selected
based
upon
co­
critical
studies,
a
chronic
oral
toxicity
study
in
dogs
with
tartrazine
and
a
chronic
oral
toxicity/
carcinogenicity
study
in
rats
with
erioglaucine.
The
incidental
oral
endpoint
was
assigned
considering
the
most
protective
NOAEL
resulting
from
the
two
studies,
500
mg/
kg/
day;
as
determined
from
the
chronic
oral
toxicity
dog
study
with
tartrazine.
The
resulting
NOAEL
was
the
highest
dose
tested
(
HDT)
in
the
selected
study.

Non­
Cancer
Level
of
Concern
(
LOC):
HED's
level
of
concern
(
LOC)
for
Aquashade
dermal
Page
6
of
26
and
inhalation
exposures
is
100
(
i.
e.,
a
margin
of
exposure
(
MOE)
less
than
100
exceeds
HED's
level
of
concern)
for
occupational
scenarios.
The
level
of
concern
is
based
on
10X
to
account
for
interspecies
extrapolation
(
differences
between
humans
and
animals)
to
humans
from
the
animal
test
species
and
10X
to
account
for
intraspecies
sensitivity
(
differences
among
humans).

Carcinogenicity
of
Aquashade:
No
evidence
for
carcinogenicity
was
seen
in
rats.
Therefore,
no
cancer
endpoints
of
concern
for
Aquashade
were
selected
and
risks
to
handlers
were
not
assessed.

Acute
Toxicity:

Table
1.3a
Acute
Toxicity
Profile
­
Admiral
WSP
(
Erioglaucine
68.13%;
Tartrazine
4.51%)

Guideline
No.
Study
Type
MRIDs
Results
Toxicity
Category
870.1100
Acute
oral
[
rats]
45281101
LD50
>
5000
mg/
kg
IV
870.1200
Acute
dermal
[
rabbit]
45144401
LD50
>
2000
mg/
kg
III
870.1300
Acute
inhalation
NA
data
requirement
waived
870.2400
Acute
eye
irritation
[
rabbit]
44902902
No
eye
irritation
III
870.2500
Acute
dermal
irritation
[
rabbit]
45086102
negative
IV
870.2600
Skin
sensitization
[
guinea
pig]
44902904
positive
Table
1.3b
Summary
of
Toxicological
Doses
and
Endpoints
for
Aquashade
Page
7
of
26
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Incidental
Oral
Short­
(
1
­
30
days)

and
Intermediate­

Term
(
1
 
6
months)
NOAEL
=
500
mg/
kg/
day
(
HDT)
(
Tartrazine)

Co­
critical:
NOAEL
=
631
mg/
kg/
day
(
Erioglaucine)
Residential
MOE
=
100
Occupational
MOE=
NA
Chronic
oral
toxicity
in
dogs
LOAEL
=
not
identified
(
Tartrazine)

Co­
critical:

Combined
chronic
toxicity/
carcinogenicity
study
in
rats
(
Erioglaucine)

LOAEL
=
1262
mg/
kg/
day
based
on
decreased
body
weight
in
females.

Dermal
Short­
(
1
­

30
days)
and
Intermediate­
Term
(
1
 
6
months)
NOAEL
=
500
mg/
kg/
day
(
HDT)
(
Tartrazine)

Co­
critical:
NOAEL
=
1200
mg/
kg/
day
(
HDT)
(
Erioglaucine)

UF
=
100X
(
dermal
absorption
rate
=
100%)
Residential
MOE
=
100
Occupational
MOE
=
100
Chronic
oral
toxicity/
carcinogenicity
study
in
rats
LOAEL
=
not
identified
(
Tartrazine)

Co­
critical
Chronic
oral
toxicity
in
dogs
LOAEL
=
not
identified
(
Erioglaucine)

Inhalation
Short­
(
1
­
30
days)
and
Intermediate­
Term
(
1
 
6
months)
NOAEL
=
500
mg/
kg/
day
(
HDT)
(
Tartrazine)

Co­
critical:
NOAEL
=
1200
mg/
kg/
day
(
HDT)
(
Erioglaucine)

UF
=
100X
(
inhalation
absorption
rate
=
100%)
Residential
MOE
=
100
Occupational
MOE
=
100
Chronic
oral
toxicity/
carcinogenicity
study
in
rats
LOAEL
=
not
identified
(
Tartrazine)

Co­
critical
Chronic
oral
toxicity
in
dogs
LOAEL
=
not
identified
(
Erioglaucine)

Cancer
(
oral,
dermal,
inhalation)
Classification:
No
evidence
or
carcinogenicity
Body
Weight:
The
adverse
effects
for
the
short­
and
intermediate­
term
dermal
and
inhalation
endpoints
are
based
on
studies
where
the
effects
were
not
gender
specific,
therefore,
the
body
weight
of
an
average
adult
(
i.
e.
70
kg)
was
used
to
estimate
exposure.
Page
8
of
26
1.4
Incident
Reports
Reference:
Review
of
Aquashade
Incident
Reports,
Chemicals
#
110303,
#
110301,
and
#
110302,
DP
Barcode:
D302184,
Jerome
Blondell,
08/
22/
05.

There
were
almost
no
reports
of
ill
effects
from
exposure
to
Aquashade
in
the
available
data
bases.
The
lack
of
incidents
further
supports
HED's
characterization
of
Aquashade
as
a
low
toxicity
pesticide
with
little
potential
for
acute
effects.

One
report
was
found
in
the
OPP
Incident
Data
System
(
IDS)
in
which
blue
water
was
observed
in
a
government
office
building
in
Ohio
in
1989.
An
investigation
found
that
Acid
Blue
9
(
a
component
of
Aquashade)
had
backflowed
into
the
building's
potable
water
system
apparently
causing
12
illnesses.
Ultimately,
it
was
determined
that
this
incident
is
too
poorly
documented
and
not
a
basis
for
conclusions
about
the
human
toxicity
of
the
product
in
question.

Reports
from
scientific
literature
suggest
that
there
was
concern
that
Aquashade
could
cloud
water
to
the
point
of
reducing
visibility
and
disorient
divers
into
lakes
treated
with
Aquashade
and
possibly
lead
to
drowning.
However,
further
studies
were
conducted
and
it
was
concluded
that
"
The
results
of
this
study
suggest
that
the
drownings
reported
in
North
Carolina
could
not
have
been
solely
or
primarily
due
to
the
addition
of
Aquashade
to
the
lake
water.
It
appears
more
likely
that
a
high
volume
of
plant
material
may
have
remained
in
the
lake
and
may
have
been
more
responsible
for
the
disorientation
of
swimmers
and
divers
who
drowned.
Under
the
conditions
of
this
experiment,
Aquashade
does
not
appear
to
reduce
the
visibility
of
water
significantly
in
a
manner
that
would
create
unsafe
swimming
hazards."

There
are
no
incidents
reported
by
the
Poison
Control
Center
(
PCC),
the
California
Department
of
Pesticide
Regulation
(
CDPR),
the
National
Pesticide
Information
Center
(
NPIC),
or
the
National
Institute
of
Occupational
Safety
and
Health's
Sentinel
Event
Notification
System
for
Occupational
Risks
(
NIOSH
SENSOR).

1.5
Summary
of
Use
Patterns
and
Formulations
1.5.1
End
Use
Products
Aquashade
is
an
aquatic
algaecide/
herbicide
which
controls
the
growth
of
algae
and
aquatic
vegetation.
Registered
use
sites
for
Aquashade
include
aquatic
uses
only.
Applications
are
generally
made
prior
to
or
early
in
the
growing
season
when
growth
is
on
the
bottom
of
the
water
body.
However,
applications
can
be
made
later
in
the
growing
season
when
growth
is
closer
to
the
surface
after
the
killing
and/
or
removal
of
any
existent
growth.
Aquashade
is
formulated
for
use
in
occupational
settings
as
either
a
liquid
or
water
soluble
packet
(
WSP)
product,
and
can
be
applied
by
pouring
or
dropping
the
WSP
in
water
body
from
the
shoreline,
or
possibly
by
boat
for
larger
water
bodies.
Residential
uses
of
Aquashade
are
formulated
as
a
liquid
product
only
(
67064­
2).
While
not
specified
on
product
labeling,
applications
could
be
made
by
LCO
handgun
Page
9
of
26
or
garden
hose
end
sprayer.

Aquashade
works
by
shading
portions
of
the
light
spectrum
required
by
underwater
plant
and
algal
growth.
If
applied
early
in
the
growth
season,
Aquashade
inhibits
photosynthesis
of
filamentous
algae
and
submerged
aquatic
vegetation.

1.5.2
Registered
Use
Categories
and
Sites
Aquashade
is
registered
for
use
in
a
variety
of
occupational
and
residential
scenarios
and
thus
these
populations
could
be
exposed
while
performing
Aquashade
applications.
A
summary
of
maximum
application
rates
for
registered
Aquashade
uses
is
presented
in
Table
1.5.2.

Table
1.5.2
Summary
of
Registered
Aquashade
Commercial
Uses
Liquid
Formulation
Product
Crop
Max
App
Rate
(
lb
ai/
acre­
foot)
Amount
of
Product
for
Area
To
Be
Treated
Application
Methods
Aquashade
(
33068­
1)
Ornamental
and
Recreational
Lakes
and
Ponds,
Fish
Rearing
and
Fish
Farming
Ponds,
Golf
Course
Ponds
1.1
0.5
gallon/
acre­
foot
(
2
ppm)
Pouring
Admiral
Liquid
(
67064­
2)
Fountains,
Fish
Farms,
Fish
Hatcheries,
Golf
Courses,
Lakes,
Manmade
Ponds,
Swimming
Ponds
0.73
0.5
gallon/
acre­
foot
(
2ppm)
Pouring
Algae
Blocker
(
8709­
6)
Garden
Ponds,
Goldfish
Ponds,
Koi
Ponds,
Ornamental
Ponds
0.22
120
ml
/
1500
gallons
Pouring
Aquashade
OA
(
33068­
2)
Aquariums,
Fountains,
Ornamental
Ponds,
Recirculated
or
Artificial
Waterscapes
0.22
1
ounce/
1000
gallons
Pouring
Water
Soluble
Packets
(
WSP)
Page
10
of
26
Admiral
WSP
(
67064­
1)
Fish
Farms,
Fish
Hatcheries,
Fountains,
Golf
Courses,
Manmade
Ponds,
Swimming
Ponds
0.73
2
WSPs/
acre­
foot
(
11
ounces)
WSP
1.5.3
Application
Methods
According
to
product
labeling,
Aquashade
can
be
applied
by
pouring
liquid
formulations
or
dropping
the
WSP
in
water
body
from
the
shoreline,
or
from
a
boat
for
larger
water
bodies.
While
not
specified
on
product
labeling,
applications
could
be
made
by
LCO
handgun
or
garden
hose
end
sprayer.

2.0
Occupational
Exposures
and
Risks
HED
determined
that
the
potential
for
occupational
exposure
to
Aquashade
exists
in
a
variety
of
occupational
environments.
The
anticipated
use
patterns
and
current
labeling
indicate
several
occupational
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
for
Aquashade
applications.
These
include
the
handling
of
Aquashade
during
mixing,
loading,
and
applying
processes
(
i.
e.
mixer/
loaders,
and
mixer/
loader/
applicators).
As
a
result,
a
risk
assessment
has
been
completed
for
the
occupational
handler
scenario.
Short­
term
(
1
to
30
days)
and
intermediate­
term
exposures
(
1
to
6
months)
may
occur;
however,
long­
term
exposures
(
greater
than
6
months)
are
not
expected.

2.1
Occupational
Handler
Exposures
and
Risks
HED
uses
the
term
Ahandlers@
to
describe
those
individuals
who
are
involved
in
the
pesticide
application
process.
HED
believes
that
there
are
distinct
job
functions
or
tasks
related
to
applications
and
that
exposures
can
vary
depending
on
the
specifics
of
each
task.
Job
requirements
(
e.
g.,
amount
of
chemical
to
be
used
in
an
application),
the
kinds
of
equipment
used,
the
target
being
treated,
and
the
level
of
protection
used
by
a
handler
can
cause
exposure
levels
to
differ
in
a
manner
specific
to
each
application
event.

HED
uses
exposure
scenarios
to
describe
the
various
types
of
handler
exposures
that
may
occur
for
a
specific
active
ingredient.
The
use
of
scenarios
as
a
basis
for
exposure
assessment
is
described
in
the
U.
S.
EPA
Guidelines
for
Exposure
Assessment
(
U.
S.
EPA;
Federal
Register
Volume
57,
Number
104;
May
29,
1992).
Information
from
the
current
labels,
use
and
usage
information,
toxicology
data,
and
exposure
data
were
all
key
components
in
the
development
of
the
exposure
scenarios.
HED
has
developed
a
series
of
general
descriptions
for
tasks
that
are
associated
with
pesticide
applications.
Tasks
associated
with
occupational
pesticide
handlers
are
categorized
using
one
of
the
following
terms:
Page
11
of
26
$
Mixers
and/
or
Loaders:
these
individuals
perform
tasks
in
preparation
for
an
application.
For
example,
prior
to
application,
mixer/
loaders
would
mix
the
Aquashade
for
open
pouring
of
Aquashade.

$
Mixer/
Loader/
Applicators
and
or
Loader/
Applicators:
these
individuals
are
involved
in
the
entire
pesticide
application
process
(
i.
e.,
they
do
all
job
functions
related
to
a
pesticide
application
event).
These
individuals
would
transfer
Aquashade
into
the
application
equipment
and
then
also
apply
it.

A
chemical
can
produce
different
effects
based
on
how
long
a
person
is
exposed,
how
frequently
exposures
occur,
and
the
level
of
exposure.
HED
classifies
exposures
up
to
30
days
as
short­
term
and
exposures
greater
than
30
days
up
to
six
months
as
intermediate­
term.
HED
completes
both
short­
and
intermediate­
term
assessments
for
occupational
scenarios
in
essentially
all
cases,
because
these
kinds
of
exposures
are
likely
and
acceptable
use/
usage
data
are
not
available
to
justify
deleting
intermediate­
term
scenarios.
Based
on
use
data
and
label
instructions,
HED
believes
that
occupational
Aquashade
exposures
may
occur
over
a
single
day
or
up
to
weeks
at
a
time
for
many
use­
patterns
and
that
intermittent
exposures
over
several
weeks
also
may
occur.
Some
applicators
may
apply
Aquashade
over
a
period
of
weeks,
because
they
are
custom
or
commercial
applicators
who
are
completing
a
number
of
applications
for
a
number
of
different
clients.
Long­
term
handler
exposures
are
not
expected
to
occur
for
Aquashade.

Other
parameters
are
also
defined
from
use
and
usage
data
such
as
application
rates
and
application
frequency.
HED
always
completes
non­
cancer
risk
assessments
using
maximum
application
rates
for
each
in
order
to
ensure
there
are
no
concerns
for
each
specific
use.

Occupational
handler
exposure
assessments
are
completed
by
HED
using
different
levels
of
risk
mitigation.
Typically,
HED
uses
a
tiered
approach.
The
lowest
tier
is
designated
as
the
baseline
exposure
scenario
(
i.
e.,
long­
sleeve
shirt,
long
pants,
shoes,
socks,
and
no
respirator).
If
risks
are
of
concern
at
baseline
attire,
then
increasing
levels
of
personal
protective
equipment
or
PPE
(
e.
g.,
gloves,
double­
layer
body
protection,
and
respirators)
are
evaluated.
If
risks
remain
a
concern
with
maximum
PPE,
then
engineering
controls
(
e.
g.,
enclosed
cabs
or
cockpits,
water­
soluble
packaging,
and
closed
mixing/
loading
systems)
are
evaluated.
This
approach
is
used
to
ensure
that
the
lowest
level
of
risk
mitigation
that
provides
adequate
protection
is
selected,
since
the
addition
of
PPE
and
engineering
controls
involves
an
additional
expense
to
the
user
and
B
in
the
case
of
PPE
B
also
involves
an
additional
burden
to
the
user
due
to
decreased
comfort
and
dexterity
and
increased
heat
stress
and
respiratory
stress.

2.1.1
Data
and
Assumptions
for
Handler
Exposure
Scenarios
2.1.1.1
Assumptions
for
Handler
Exposure
Scenarios
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
handler
risk
assessments.
The
assumptions
used
in
the
risk
assessment
calculations
are
detailed
Page
12
of
26
below:

C
Occupational
handler
exposure
estimates
were
based
on
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF).

C
HED
has
developed
standard
unit
exposure
values
for
many
occupational
scenarios
to
ensure
consistency
in
exposure
assessments.
These
standard
values
were
used
to
calculate
handler
exposures
for
the
associated
scenarios.
For
those
scenarios
where
standard
values
have
not
been
developed,
surrogate
values
based
on
a
similar
scenario
were
used.

C
The
adverse
effects
for
the
short­
and
intermediate­
term
dermal
and
inhalation
endpoints
are
based
on
studies
where
the
effects
were
observed
in
males
and
females,
therefore,
the
body
weight
of
an
average
adult
(
i.
e.
70
kg)
was
used
to
estimate
exposure.

C
For
non­
cancer
assessments,
HED
assumes
the
maximum
application
rates
allowed
by
labels
in
its
risk
assessments.

C
The
average
occupational
workday
is
assumed
to
be
8
hours.

C
The
daily
areas
treated
were
defined
for
each
handler
scenario
(
in
appropriate
units)
by
determining
the
amount
that
can
be
reasonably
treated
in
a
single
day
(
e.
g.,
acres,
square
feet,
cubic
feet,
or
gallons
per
day).
When
possible,
the
assumptions
for
daily
areas
treated
are
taken
from
the
Health
Effects
Division
Science
Advisory
Committee
on
Exposure
SOP
#
9:
Standard
Values
for
Daily
Acres
Treated
in
Agriculture,
which
was
completed
on
July
5,
2000.
Since
Aquashade
is
not
used
in
agriculture
the
above
source
is
not
applicable.
Therefore,
the
daily
area
treated
with
Aquashade
was
investigated
and
was
assumed
to
be
25
acre­
feet
per
day
[
Personal
Communication
per
Email
from
Dr.
Kurt
Getsinger
(
USACE)
to
J.
Carter
(
OPP,
BEAD),
8/
22/
05].
This
high­
end
estimate
is
recognized
to
be
conservative;
however,
the
value
is
assumed
to
result
in
risks
that
represent
reasonable
worst­
case
estimates
of
exposure
to
occupational
handlers
of
Aquashade.

2.1.1.2
Exposure
Data
for
Handler
Exposure
Scenarios
HED
uses
unit
exposures
to
assess
handler
exposures
to
pesticides.
Unit
exposures
are
estimates
of
the
amount
of
exposure
to
an
active
ingredient
a
handler
receives
while
performing
various
handler
tasks
and
are
expressed
in
terms
of
micrograms
or
milligrams
of
active
ingredient
per
pounds
of
active
ingredient
handled.
HED
has
developed
a
series
of
unit
exposures
that
are
unique
for
each
scenario
typically
considered
in
our
assessments
(
i.
e.,
there
are
different
unit
exposures
for
different
types
of
application
equipment,
job
functions,
and
levels
of
protection).
The
unit
exposure
concept
has
been
established
in
the
scientific
literature
and
also
through
various
exposure
monitoring
guidelines
published
by
the
U.
S.
EPA
and
international
organizations
such
as
Health
Canada
and
OECD
(
Organization
for
Economic
Cooperation
and
Development).
Page
13
of
26
Pesticide
Handler
Exposure
Database
(
PHED)
Version
1.1
(
August
1998):
PHED
was
designed
by
a
task
force
of
representatives
from
the
U.
S.
EPA,
Health
Canada,
the
California
Department
of
Pesticide
regulation,
and
member
companies
of
the
American
Crop
Protection
Association.
PHED
is
a
software
system
consisting
of
two
parts
B
a
database
of
measured
exposures
for
workers
involved
in
the
handling
of
pesticides
under
actual
field
conditions
and
a
set
of
computer
algorithms
used
to
subset
and
statistically
summarize
the
selected
data.
Currently,
the
database
contains
values
for
over
1,700
monitored
individuals
(
i.
e.,
replicates).

Users
select
criteria
to
subset
the
PHED
database
to
reflect
the
exposure
scenario
being
evaluated.
The
subsetting
algorithms
in
PHED
are
based
on
the
central
assumption
that
the
magnitude
of
handler
exposures
to
pesticides
are
primarily
a
function
of
activity
(
e.
g.,
mixing/
loading,
mixing/
loading/
applying),
formulation
type
(
e.
g.,
liquids,
water
soluble
packets),
application
method
(
e.
g.,
pouring,
garden
hose
end
sprayer),
and
clothing
scenarios
(
e.
g.,
gloves,
double
layer
clothing).

Once
the
data
for
a
given
exposure
scenario
have
been
selected,
the
data
are
normalized
(
i.
e.,
divided
by)
by
the
amount
of
pesticide
handled
resulting
in
standard
unit
exposures
(
milligrams
of
exposure
per
pound
of
active
ingredient
handled).
Following
normalization,
the
data
are
statistically
summarized.
The
distribution
of
exposure
for
each
body
part
(
e.
g.,
chest,
upper
arm)
is
categorized
as
normal,
lognormal,
or
Aother@
(
i.
e.,
neither
normal
nor
lognormal).
A
central
tendency
value
is
then
selected
from
the
distribution
of
the
exposure
for
each
body
part.
These
values
are
the
arithmetic
mean
for
normal
distributions,
the
geometric
mean
for
lognormal
distributions,
and
the
median
for
all
Aother@
distributions.
Once
selected,
the
central
tendency
values
for
each
body
part
are
composited
into
a
Abest
fit@
exposure
value
representing
the
entire
body.

The
unit
exposures
calculated
by
PHED
generally
range
from
the
geometric
mean
to
the
median
of
the
selected
data
set.
To
add
consistency
and
quality
control
to
the
values
produced
from
this
system,
the
PHED
Task
Force
has
evaluated
all
data
within
the
system
and
has
developed
a
set
of
grading
criteria
to
characterize
the
quality
of
the
original
study
data.
The
assessment
of
data
quality
is
based
on
the
number
of
observations
and
the
available
quality
control
data.
These
evaluation
criteria
and
the
caveats
specific
to
each
exposure
scenario
are
summarized
in
Appendix
B,
Table
B1.
While
data
from
PHED
provide
the
best
available
information
on
handler
exposures,
it
should
be
noted
that
some
aspects
of
the
included
studies
(
e.
g.,
duration,
acres
treated,
pounds
of
active
ingredient
handled)
may
not
accurately
represent
labeled
uses
in
all
cases.
HED
has
developed
a
series
of
tables
of
standard
unit
exposure
for
many
occupational
scenarios
that
can
be
utilized
to
ensure
consistency
in
exposure
assessments.
Unit
exposures
are
used
which
represent
different
levels
of
personal
protection
as
described
above.
Protection
factors
were
used
to
calculate
unit
exposures
for
varying
levels
of
personal
protection
if
data
were
not
available.

ORETF
Handler
Studies
(
MRID
449722­
01):
A
report
was
submitted
by
the
ORETF
Page
14
of
26
(
Outdoor
Residential
Exposure
Task
Force)
that
presented
data
in
which
the
application
of
various
products
used
on
turf
by
homeowners
and
lawn
care
operators
(
LCOs)
was
monitored.
All
of
the
data
submitted
in
this
report
were
completed
in
a
series
of
studies.
These
studies
are
summarized
in
the
HED
Memorandum
"
Summary
of
HED's
Reviews
of
ORETF
Chemical
Handler
Exposure
Studies:
MRID
449722­
01",
DP
Barcode
D261948
of
April
30,
2001.
The
studies
performed
used
dacthal
as
a
surrogate
compound
with
a
target
application
rate
of
2.0
lbs/
ai.
All
studies
were
conducted
in
accordance
with
current
Agency
guidelines,
have
been
reviewed
by
HED
and
Health
Canada,
and
the
data
generated
were
of
high
quality.

2.1.2
Aquashade
Handler
Exposure
Scenarios
Pesticide
handler
exposure
to
Aquashade
is
likely
to
occur
during
its
use
in
a
variety
of
occur
during
its
use
in
a
variety
of
occupational
environments.
The
anticipated
use
patterns
and
current
labeling
indicate
several
occupational
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
for
Aquashade
applications.
The
quantitative
exposure/
risk
assessment
developed
for
occupational
handlers
of
Aquashade
is
based
on
the
following
scenarios.

Mixer/
Loaders:
(
1)
Liquids
for
Pouring
Applications
Mixer/
Loader/
Applicators:
(
2)
Liquids
for
Garden
Hose­
End
Sprayer
(
ORETF)
(
3)
Liquids
for
LCO
Handgun
(
ORETF)

2.1.3
Non­
cancer
Aquashade
Handler
Exposure
and
Assessment
2.1.3.1
Non­
cancer
Aquashade
Handler
Exposure
and
Risk
Calculations
Daily
Exposure:
Daily
inhalation
handler
exposures
are
estimated
for
each
applicable
handler
task
with
the
application
rate,
the
area
treated
in
a
day,
and
the
applicable
inhalation
unit
exposure
using
the
following
formula:

Where:

Daily
Exposure
=
Amount
(
mg
or
Fg
ai/
day)
deposited
on
the
surface
of
the
skin
that
is
available
for
inhalation
absorption;
 
 

 
 

 
 

 
 

  
 

  
 

  
 

  
 

 
 

 
 

 
 

 
 

day
area
Treated
Area
Daily
x
area
ai
lbs
Rate
n
Applicatio
x
handled
ai
lb
ai
mg
Exposure
Unit
=
day
ai
mg
Exposure
Daily
Page
15
of
26
Unit
Exposure
=
Unit
exposure
value
(
mg
or

g
ai/
lb
ai)
derived
from
August
1998
PHED
data,
from
ORETF
data,
study
data;
Application
Rate
=
Normalized
application
rate
based
on
a
logical
unit
treatment,
such
as
acres,
square
feet,
or
gallons.
Maximum
values
are
generally
used
(
lb
ai/
A,
lb
ai/
sq
ft,
lb
ai/
gal)
and
Daily
Area
Treated
=
Normalized
application
area
based
on
a
logical
unit
treatment
such
as
acres
(
A/
day),
square
feet
(
sq
ft/
day),
OR
gallons
per
day
(
gal/
day).

Daily
Dose:
The
daily
inhalation
dose
is
calculated
by
normalizing
the
daily
exposure
by
body
weight
and
adjusting,
if
necessary,
with
an
appropriate
inhalation
absorption
factor.
HED
did
not
identify
dermal
toxicity
endpoints
for
Aquashade,
therefore,
only
inhalation
exposures
were
assessed.
For
all
short­
and
intermediate­
term
exposure
scenarios
for
Aquashade,
an
average
male
adult
body
weight
of
70
kilograms
was
used,
since
the
studies
are
based
on
effects
observed
in
males
and
females.
An
absorption
factor
of
100%
was
used
for
inhalation
dose
calculations.
Daily
dose
was
calculated
using
the
following
formula:

Where:

Average
Daily
Dose
=
Absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
Daily
Exposure
=
Amount
(
mg
ai/
day)
inhaled
that
is
available
for
inhalation
absorption;
Absorption
Factor
=
A
measure
of
the
amount
of
chemical
that
crosses
a
biological
boundary
such
as
the
skin
or
lungs
(%
of
the
total
available
absorbed);
and
Body
Weight
=
Body
weight
determined
to
represent
the
population
of
interest
in
a
risk
assessment
(
kg).

Margins
of
Exposure:
Non­
cancer
inhalation
risks
for
each
applicable
handler
scenario
are
calculated
using
a
Margin
of
Exposure
(
MOE),
which
is
a
ratio
of
the
toxicological
endpoint
to
the
daily
dose
of
concern.
All
MOE
values
were
calculated
for
inhalation
exposure
levels.

Where:

MOE
=
Margin
of
Exposure,
value
used
by
HED
to
represent
risk
or
how
close
a
chemical
exposure
is
to
being
a
concern
(
unitless);
ADD
=
Average
Daily
Dose
or
the
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
(
)
(
)
mg/
kg/
day
Dose
Daily
Average
mg/
kg/
day
LOAEL
NOAEL
=
MOE
 
(
)

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

(
kg)
Weight
Body
/
100)
(%
Factor
Absorption
x
day
ai
mg
Exposure
Daily
=
/
day
/
kg
mg
Dose
Daily
Average
Page
16
of
26
body
weight/
day);
and
NOAEL
or
LOAEL
=
Dose
level
in
a
toxicity
study,
where
no
observed
adverse
effects
(
NOAEL)
or
where
the
lowest
observed
adverse
effects
(
LOAEL)
occurred
in
the
study
Risk
values
are
presented
for
the
route
of
exposure
(
i.
e.,
inhalation)
in
each
scenario,
because
risk
mitigation
measures
are
specific
to
the
route
of
exposure.

2.1.3.2
Aquashade
Non­
cancer
Risk
Summary
(
using
PHED
data)

Short­
and
Intermediate­
term
Total
Risks:
All
occupational
handler
scenarios
assessed
(
dermal
and
inhalation)
resulted
in
estimated
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
Short­
and
intermediate­
term
MOEs
do
not
differ
because
they
share
the
same
toxicological
endpoint.
A
summary
of
the
MOEs
estimated
for
handlers
are
presented
in
Table
2.1.3.2.
Page
17
of
26
Table
2.1.3.2:
Short­
and
Intermediate­
term
Baseline
Exposures
and
Risks
for
Occupational
Handlers
of
Aquashade
Exposure
Scenario
(
Scenario
#)
Crop1
Dermal
Unit
Exposure
(
mg/
lb
ai)
2
Inhalation
Unit
Exposure
(
Ug/
lb
ai)
3
Application
Rate
(
lb
ai
/
acre
foot)
4
Area
Treated
Daily
(
acrefeet
5
Baseline
Dermal
MOE
6
Baseline
Inhalation
MOE7
Mixer/
Loader
Liquids
for
Pouring
Applications
(
1)
Ornamental
and
Recreational
Lakes
and
Ponds
3.1
1.2
1.1
25
410
1100000
Liquids
for
Pouring
Applications
(
1)
Fountains,
Fish
Farms,
Fish
Hatcheries,
Golf
Courses,
Lakes,
Manmade
Ponds,
Swimming
Ponds
3.1
1.2
0.73
25
620
1600000
Mixer/
Loader/
Applicator
Liquids
for
Garden
Hose
End
Sprayer
(
2)
Ornamental
and
Recreational
Lakes
and
Ponds
0.45
11
1.1
25
2800
120000
Liquids
for
Garden
Hose
End
Sprayer
(
2)
Fountains,
Fish
Farms,
Fish
Hatcheries,
Golf
Courses,
Lakes,
Manmade
Ponds,
Swimming
Ponds
0.45
11
0.73
25
4300
170000
Liquids
for
LCO
Handgun
(
ORETF)
(
3)
Ornamental
and
Recreational
Lakes
and
Ponds
0.50
1.9
1.1
25
2500
670000
Liquids
for
LCO
Handgun
(
ORETF)
(
3)
Fountains,
Fish
Farms,
Fish
Hatcheries,
Golf
Courses,
Lakes,
Manmade
Ponds,
Swimming
Ponds
0.50
1.9
0.73
25
3800
100000
Page
18
of
26
1
Crops
and
use
patterns
are
from
product
labeling.
2Baseline
dermal
unit
exposures
represent
long
pants,
long
sleeved
shirts,
shoes,
and
socks.
Values
are
reported
in
the
PHED
Surrogate
Exposure
Guide
dated
August
1998
or
are
from
data
submitted
by
the
Outdoor
Residential
Exposure
Task
Force
dated
May
2000.
3Baseline
inhalation
unit
exposures
represent
no
respirator.
Values
are
reported
in
the
PHED
Surrogate
Exposure
Guide
dated
August
1998
or
are
from
data
submitted
by
the
Outdoor
Residential
Exposure
Task
Force
dated
May
2000.
4Application
rates
are
based
on
maximum
values
found
in
various
sources
including
LUIS
and
various
labels.
In
most
scenarios,
a
range
of
maximum
application
rates
is
used
to
represent
the
range
of
rates
for
different
crops/
sites/
uses.
5Amount
treated
is
based
on
the
area
or
gallons
that
can
be
reasonably
applied
in
a
single
day
for
each
exposure
scenario
of
concern
based
on
the
application
method
and
formulation/
packaging
type.
(
Standard
EPA/
OPP/
HED
values).
6
Dermal
MOE
=
NOAEL
(
500
mg/
kg/
day)
/
Daily
dermal
dose
(
mg/
kg/
day).
MOEs
are
reported
to
2
significant
figures.
7Inhalation
MOE
=
NOAEL
(
500
mg/
kg/
day)
/
Daily
inhalation
dose
(
mg/
kg/
day).
MOEs
are
reported
to
2
significant
figures.

HED
believes
that
the
risk
estimates
presented
in
this
occupational
assessment
represent
the
best
quality
results
that
could
be
produced
given
the
exposure,
use,
and
toxicology
data
that
are
available.
HED
also
believes
that
the
risks
represent
reasonable
worst­
case
estimates
of
exposure,
because
maximum
application
rates
are
coupled
with
medium­
to
high­
end
estimates
of
area
treated
daily
to
define
risk
estimates
that
likely
fall
in
the
upper
percentiles
of
the
actual
exposure
distributions.
Using
these
worst­
case
assumptions,
estimated
occupational
handler
MOEs
for
all
exposure
scenarios
are
greater
than
100
and
are,
therefore,
not
of
concern.

2.1.4
Cancer
Aquashade
Handler
Exposure
and
Risk
Assessment
No
cancer
endpoints
of
concern
for
Aquashade
were
identified;
therefore
cancer
risks
to
handlers
were
not
assessed.

2.1.5
Summary
of
Risk
Concerns
and
Data
Gaps
for
Occupational
Handlers
2.1.5.1
Summary
of
Risk
Concerns
A
summary
of
the
short­
and
intermediate­
term
risks
(
dermal
and
inhalation)
for
each
exposure
scenario
is
presented
in
Table
2.1.3.2.
The
calculated
occupational
handler
exposures
for
all
scenarios
resulted
in
estimated
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
Shortand
intermediate­
term
MOEs
do
not
differ
because
they
share
the
same
toxicological
endpoint.
Short­
and
intermediate­
term
dermal
MOEs
range
from
410
(
Liquids
for
Pouring
Applications)
to
4,300
(
Liquids
for
Garden
Hose­
End
Sprayer),
and
short­
and
intermediate­
term
inhalation
MOEs
range
from
120,000
(
Liquids
for
Garden
Hose
End
Sprayer)
to
1,600,000
(
Liquids
for
Pouring
Applications).

2.1.5.2
Summary
of
Data
Gaps
There
are
no
occupational
handler
scenarios
for
Aquashade
that
have
data
gaps.

2.1.6
Recommendations
for
Refining
Occupational
Handler
Risk
Page
19
of
26
Assessment
In
order
to
refine
this
occupational
risk
assessment,
data
on
actual
use
patterns
including
rates,
timing,
and
areas
treated
would
better
characterize
Aquashade
risks.
Exposure
studies
for
equipment
types
that
lack
data
or
that
are
not
well
represented
in
PHED
(
e.
g.,
because
of
low
replicate
numbers
or
data
quality)
should
also
be
considered
based
on
a
review
of
the
quality
of
the
data
used
in
this
assessment.

2.2
Occupational
Postapplication
Exposures
and
Risks
HED
uses
the
term
A
postapplication
@

to
describe
exposures
that
occur
when
individuals
are
present
in
an
environment
that
has
been
previously
treated
with
a
pesticide
(
also
referred
to
as
reentry
exposure).
Such
exposures
may
occur
when
workers
enter
previously
treated
areas
to
perform
job
functions,
including
activities
related
to
crop
production,
such
as
scouting
for
pests
or
harvesting.
Postapplication
exposure
levels
vary
over
time
and
depend
on
such
things
as
the
type
of
activity
(
scouting,
harvesting,
etc.),
the
nature
of
the
crop
or
target
that
was
treated,
the
type
of
pesticide
application
(
foliar,
soil­
incorporated,
banded,
etc.)
and
the
chemical
=

s
degradation
properties.
In
addition,
the
timing
of
pesticide
applications,
relative
to
harvest
activities,
can
greatly
reduce
the
potential
for
postapplication
exposure.

Aquashade
is
generally
applied
prior
to
or
early
in
the
growing
season
when
growth
is
on
the
bottom
of
the
water
body.
Applications
can
also
be
made
later
in
the
growing
season
when
growth
is
closer
to
the
surface
after
the
killing
and/
or
removal
of
any
existent
growth.
Since
Aquashade
is
an
algaecide/
herbicide,
HED
is
not
aware
of
any
postapplication
activities
which
may
result
in
exposure.
No
harvesting
is
required,
and
while
scouting
may
include
identifying
any
algae
or
aquatic
weed
regrowth,
these
activities
should
not
require
contact
with
the
treated
water
body.
For
these
reasons,
occupational
postapplication
exposure
of
workers
to
previously
treated
water
bodies
is
expected
to
be
negligible
and
was
not
assessed.
Furthermore,
any
postapplication
activities
that
could
potentially
occur
would
not
be
expected
to
exceed
those
assessed
from
residential
exposures
to
Aquashade
which
are
not
of
concern.

In
accordance
with
the
Worker
Protection
Standard
(
WPS),
a
restricted­
entry
interval
(
REI)
is
established
to
mitigate
contact
with
a
pesticide
in
treated
agricultural
areas.
However,
since
Aquashade
has
no
agricultural
applications
an
REI
was
not
required.

3.0
Residential
and
Other
Non­
Occupational
Exposures
and
Risks
Aquashade
is
labeled
for
consumer
use
to
control
aquatic
algae
and
weeds
in
ponds
and
lakes.
The
anticipated
use
patterns
and
current
labeling
indicate
several
residential
handler
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
to
make
Aquashade
applications.
Residents
or
consumers
applying
Aquashade
products
to
ponds
or
lakes
may
be
exposed
for
short­
term
(
1
to
30
days)
duration
through
skin
contact
or
by
inhalation.
Page
20
of
26
Postapplication
exposures
to
children
and
adults
that
contact
Aquashade­
treated
swimming
ponds
are
anticipated.
To
address
the
risk
of
such
exposures,
a
screening
tool
called
the
Swimmer
Exposure
Assessment
Model
(
SWIMODEL)
was
applied.
The
SWIMODEL
uses
well­
accepted
screening
exposure
assessment
equations
to
calculate
the
total
worst­
case
exposure
for
swimmers
expressed
as
a
mass­
based
intake
value
(
mg/
event).
Postapplication
residential
exposure
durations
are
expected
to
be
short­
and
intermediate­
term
(
1
to
6
months)
in
duration.

To
better
quantify
residential
Aquashade
hazard,
results
from
residential
handler
and
residential
postapplication
risk
assessments
were
aggregated.
Aggregate
calculations
of
residential
exposure
were
performed
using
worst­
case
MOEs
resulting
from
each
assessment.

3.1
Residential
Handler
Exposures
and
Risks
HED
uses
the
term
"
handlers"
to
describe
those
individuals
who
are
involved
in
the
pesticide
application
process.
HED
believes
that
there
are
distinct
tasks
related
to
applications
and
that
exposures
can
vary
depending
on
the
specifics
of
each
task
as
was
described
above
for
occupational
handlers.

3.1.1
Handler
Exposure
Scenarios
Scenarios
are
used
to
define
risks
based
on
the
U.
S.
EPA
Guidelines
for
Exposure
Assessment
(
U.
S.
EPA;
Federal
Register
Volume
57,
Number
104;
May
29,
1992).
Assessing
exposures
and
risks
resulting
from
residential
uses
is
very
similar
to
assessing
occupational
exposures
and
risks,
with
the
following
exceptions:

 
Residential
handler
exposure
scenarios
are
considered
to
be
short­
term
only,
due
to
the
infrequent
use
patterns
associated
with
homeowner
products.

 
A
tiered
approach
for
personal
protection
using
increasing
levels
of
PPE
is
not
used
in
residential
handler
risk
assessments.
Homeowner
handler
assessments
are
based
on
the
assumption
that
individuals
are
wearing
shorts,
short­
sleeved
shirts,
socks,
and
shoes.

 
Homeowner
handlers
are
expected
to
complete
all
tasks
associated
with
the
use
of
a
pesticide
product
including
mixing/
loading
if
needed
as
well
as
the
application.

 
Label
use
rates
and
use
information
specific
to
residential
products
serve
as
the
basis
for
the
risk
calculations.

 
Area/
volumes
of
spray
or
chemical
used
in
the
risk
assessment
are
based
on
HED's
guidance
specific
to
residential
use
patterns.

Aquashade
is
labeled
for
consumer
use
to
control
aquatic
algae
and
weeds
in
ponds
and
lakes;
Page
21
of
26
therefore,
pesticide
handler
exposure
to
Aquashade
is
likely
to
occur
during
its
use.
The
anticipated
use
patterns
and
current
labeling
indicate
several
residential
handler
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
be
potentially
used
for
consumer
Aquashade
applications.
The
quantitative
exposure/
risk
assessment
developed
for
residential
handlers
is
based
on
the
following
scenarios.

Mixer/
Loader/
Applicators:
(
1)
Liquids
for
Pouring
Applications
(
using
PHED
mixer/
loader
data)
(
2)
Liquids
for
Garden
Hose­
End
Sprayer
(
ORETF)
(
3)
Liquids
for
LCO
Handgun
(
ORETF)

3.1.2
Data
and
Assumptions
for
Handler
Exposure
Scenarios
A
series
of
assumptions
served
as
the
basis
for
completing
the
residential
handler
risk
assessments.
Each
assumption
and
factor
is
detailed
below.
In
addition
to
these
factors,
unit
exposure
values
were
used
to
calculate
risk
estimates.
Mostly,
these
unit
exposure
values
were
taken
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
studies.
Both
PHED
and
the
individual
studies
are
presented
below.
[
Note:
Several
of
the
assumptions
and
factors
used
for
the
assessment
are
similar
to
those
used
in
the
occupational
assessment
presented
above.
As
such,
only
factors
that
are
unique
to
the
residential
scenarios
are
presented
below.]

Assumptions
and
Factors:
The
assumptions
and
factors
used
in
the
risk
calculations
include:

C
HED
has
developed
standard
unit
exposure
values
for
many
occupational
scenarios
to
ensure
consistency
in
exposure
assessments.
These
standard
values
were
used
to
calculate
handler
exposures
for
the
associated
scenarios.
For
those
scenarios
where
standard
values
have
not
been
developed,
surrogate
values
based
on
a
similar
scenario
were
used.

C
HED
always
considers
the
maximum
application
rates
allowed
by
labels
in
its
risk
assessments.
If
additional
information
such
as
average
or
typical
rates
are
available,
these
values
also
may
be
used
to
allow
risk
managers
to
make
a
more
informed
risk
management
decision.

3.1.3
Residential
Handler
Exposure
and
Non­
Cancer
Risk
Estimates
Non­
cancer
risks
were
calculated
using
the
Margin
of
Exposure
(
MOE)
as
described
in
Section
2.1.3.
Assessing
exposures
and
risks
resulting
from
residential
uses
is
very
similar
to
assessing
occupational
exposures
and
risks,
except
as
described
in
Section
3.1.1.
The
overall
uncertainty
factor
applied
to
Aquashade
handler
risk
assessments
is
an
MOE
of
100,
which
is
based
on
10X
for
inter­
species
extrapolation,
and
10X
for
intra­
species
variation.

Risk
Summary:
A
summary
of
the
short­
term
risks
(
dermal
and
inhalation)
for
each
exposure
Page
22
of
26
scenario
is
presented
below
in
Table
3.1.3.
All
residential
handler
scenarios
assessed
resulted
in
estimated
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
Short­
and
intermediateterm
MOEs
do
not
differ
because
they
share
the
same
toxicological
endpoint.
Residential
shortterm
dermal
MOEs
range
from
1,930
(
Liquids
for
Pouring
Applications)
to
16,000
(
Liquids
for
LCO
Handgun),
and
short­
term
inhalation
MOEs
range
from
550,000
(
Liquids
for
Garden
Hose
End
Sprayer)
to
6,600,000
(
Liquids
for
Pouring
Applications).
Page
23
of
26
Table
3.1.3:
Short­
term
Exposures
and
Risks
for
Residential
Handlers
of
Aquashade
Exposure
Scenario
(
Scenario
#)
Crop1
Dermal
Unit
Exposure
(
mg/
lb
ai)
2
Inhalation
Unit
Exposure
(
Ug/
lb
ai)
3
Application
Rate3
(
lb
ai
/
acre
foot)
4
Area
Treated
Daily
(
acrefeet
5
Surface
Area
(
acres)
Depth
of
Water
Body
(
feet)
Baseline
Dermal
MOE
6
Baseline
Inhalation
MOE7
Mixer/
Loader/
Applicator
Liquids
for
Pouring
Applications
(
1)
Fountains,
Fish
Farms,
Fish
Hatcheries,
Golf
Courses,

Lakes,
Manmade
Ponds,

Swimming
Ponds
3.1
1.2
0.73
8
8
1
1930
5000000
Liquids
for
Pouring
Applications
(
1)
Ornamental
and
Recreational
Lakes
and
Ponds
3.1
1.2
1.1
4
1
4
2600
6600000
Liquids
for
Garden
Hose
End
Sprayer
(
ORETF)
(
2)
Fountains,
Fish
Farms,
Fish
Hatcheries,
Golf
Courses,

Lakes,
Manmade
Ponds,

Swimming
Ponds
2.6
11
0.73
8
8
1
2300
550000
Liquids
for
Garden
Hose
End
Sprayer
(
ORETF)
(
2)
Ornamental
and
Recreational
Lakes
and
Ponds
2.6
11
1.1
4
1
4
3100
720000
Liquids
for
LCO
Handgun
(
ORETF)
(
3)
Fountains,
Fish
Farms,
Fish
Hatcheries,
Golf
Courses,

Lakes,
Manmade
Ponds,

Swimming
Ponds
0.50
1.9
0.73
8
8
1
12000
3100000
Liquids
for
LCO
Handgun
(
ORETF)
(
3)
Ornamental
and
Recreational
Lakes
and
Ponds
0.50
1.9
1.1
4
1
4
16000
4200000
Page
24
of
26
1
Crops
and
use
patterns
are
from
product
labeling.
2Baseline
dermal
unit
exposures
represent
short
pants
and
short
sleeved
shirt
Values
are
reported
in
the
PHED
Surrogate
Exposure
Guide
dated
August
1998
or
are
from
data
submitted
by
the
Outdoor
Residential
Exposure
Task
Force
dated
May
2000.
3Baseline
inhalation
unit
exposures
represent
no
respirator.
Values
are
reported
in
the
PHED
Surrogate
Exposure
Guide
dated
August
1998
or
are
from
data
submitted
by
the
Outdoor
Residential
Exposure
Task
Force
dated
May
2000.
4Application
rates
are
based
on
maximum
values
found
in
various
sources
including
LUIS
and
various
labels.
In
most
scenarios,
a
range
of
maximum
application
rates
is
used
to
represent
the
range
of
rates
for
different
crops/
sites/
uses.
Most
application
rates
upon
which
the
analysis
is
based
are
presented
as
lb
ai/
A.
5Amount
treated
is
based
on
the
area
or
gallons
that
can
be
reasonably
applied
in
a
single
day
for
each
exposure
scenario
of
concern
based
on
the
application
method
and
formulation/
packaging
type.
(
Standard
EPA/
OPP/
HED
values).
6
Dermal
MOE
=
NOAEL
(
500
mg/
kg/
day)
/
Daily
dermal
dose
(
mg/
kg/
day).
MOEs
are
reported
to
2
significant
figures.
7Inhalation
MOE
=
NOAEL
(
500
mg/
kg/
day)
/
Daily
inhalation
dose
(
mg/
kg/
day).
MOEs
are
reported
to
2
significant
figures.

3.1.4
Residential
Handler
Exposure
and
Risk
Estimates
for
Cancer
Residential
handler
cancer
risks
were
not
assessed,
since
no
toxicological
endpoint
of
concern
for
cancer
was
selected.

3.1.5
Recommendations
for
Refining
Residential
Handler
Risk
Assessment
In
order
to
refine
this
residential
risk
assessment,
more
data
on
actual
use
patterns
including
rates,
timing,
and
areas
treated
would
better
characterize
Aquashade
risks.
Exposure
studies
for
many
equipment
types
that
lack
data
or
that
are
not
well
represented
in
PHED
(
i.
e.,
because
of
low
replicate
numbers
or
data
quality)
should
also
be
considered
based
on
a
review
of
the
quality
of
the
data
used
in
this
assessment.

3.2
Residential
Postapplication
Exposures
and
Risks
HED
uses
the
term
postapplication
to
describe
exposures
to
individuals
that
occur
as
a
result
of
being
in
an
environment
that
has
been
previously
treated
with
a
pesticide.
Aquashade
can
be
used
in
areas
that
can
be
frequented
by
the
general
population
including
residential
areas
(
i.
e.,
swimming
ponds).
There
is
potential
for
dermal,
ingestion,
aural,
buccal/
sublingual,
and
nasal/
orbital
routes
of
exposure
to
adults
and
children
following
its
residential
application.
The
potential
for
incidental
exposures
of
short­
term
duration
exist
from
the
day
of
application
to
the
water
body.
Intermediate­
term
exposures
could
also
occur
and
were
considered
as
well.

3.2.1
Residential
Postapplication
Exposure
Scenarios
In
order
to
assess
short­
and
intermediate­
term
postapplication
risks
for
children
and
adults
exposed
to
Aquashade­
treated
residential
swimming
ponds,
the
SWIMODEL
was
applied.
The
SWIMODEL
uses
well­
accepted
screening
exposure
assessment
equations
to
calculate
the
total
worst­
case
exposure
for
swimmers
expressed
as
a
mass­
based
intake
value
(
mg/
event).
Page
25
of
26
3.2.2
Data
and
Assumptions
for
Residential
Postapplication
Exposure
Scenarios
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
residential
postapplication
risk
assessments.
The
assumptions
and
factors
used
in
the
risk
calculations
are
consistent
with
current
Agency
policy
for
completing
residential
exposure
assessments
(
i.
e.,
SOPs
for
Residential
Exposure
Assessment).
The
SWIMODEL
was
applied
incorporating
the
assumptions
and
factors
of
the
SOPs
for
Residential
Exposure
Assessment.
The
values
used
in
this
assessment
include:

 
The
skin
surface
area
of
adults
is
expected
to
be
21,000
cm
²
as
cited
in
the
SOPs
for
Residential
Exposure
Assessment.
This
is
the
95th
percentile
value
for
females
(
EPA
Exposure
Factors
Handbook,
1997).
 
The
body
weight
for
children
is
assumed
to
be
22
kg
as
cited
in
the
SOPs
for
Residential
Exposure
Assessment.
This
is
a
mean
value
for
6
year
old
children.
 
The
skin
surface
area
for
children
is
assumed
to
be
9,000
cm2
as
cited
in
the
SOPs
for
Residential
Exposure
Assessment.
This
is
the
90th
percentile
value
for
male
and
female
children.
 
The
assumed
mean
ingestion
rate
is
0.05
liters
per
hour
for
both
adults
and
children
as
cited
in
the
SOPs
for
Residential
Exposure
Assessment.
This
value
may
be
greater
for
young
children
playing
in
water
and
accidentally
ingesting
a
remarkable
quantity
of
water
(
U.
S.
EPA
SAP,
1999).
 
The
exposure
time
is
assumed
to
be
3
hours
per
day.
This
is
the
90th
percentile
value
for
time
spent
swimming
in
a
freshwater
pool.
(
EPA
Child
Specific
Exposure
Factors
Handbook,
2002).
 
The
body
weight
for
adult
short­
and
intermediate­
term
exposures
is
assumed
to
be
70
kg
because
the
studies
used
to
select
endpoints
were
not
gender
specific.
 
Acute­
term
exposures
were
not
assessed
because
no
studies
were
performed
from
which
to
determine
an
endpoint
for
the
exposure
duration.
 
Postapplication
residential
risks
are
based
on
maximum
application
rates
or
values
specified
in
the
SOPs
for
Residential
Exposure
Assessment.
The
maximum
label
application
rate
of
2
mg/
liter
(
2000
ppb)
was
used
to
assess
short­
and
intermediate­
term
Aquashade
exposures.

3.2.3
Residential
Postapplication
Exposure
and
Noncancer
Risk
Estimates
Risks
were
calculated
for
residential
handler
and
postapplication
exposures
using
the
Margin
of
Exposure
(
MOE)
approach;
the
MOE
is
a
ratio
of
the
body
burden
to
the
toxicological
endpoint
of
concern.
All
short­
and
intermediate­
term
residential
postapplication
scenarios
assessed
(
dermal,
ingestion,
aural,
buccal/
sublingual,
and
nasal/
orbital
routes
of
exposure)
resulted
in
estimated
combined
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
A
summary
of
these
MOEs
are
presented
in
Table
3.2.3.
Page
26
of
26
Table
3.2.3
Recreational
Swimmer
Aquashade
MOEs
Exposed
Person
Exposure
Duration
Water
Concentration
(
µ
g/
L)
Dose
(
mg/
kg/
day)
NOAEL
(
mg/
kg/
day)
MOE
Child
 
22
kg
2000
0.10
500
4900
Adult
 
70
kg
Short­/

Intermediateterm
2000
0.032
500
15600
3.2.4
Residential
Postapplication
Exposure
and
Risk
Estimates
for
Cancer
No
cancer
endpoints
of
concern
for
Aquashade
were
identified;
therefore
postapplication
cancer
risks
to
handlers
were
not
assessed.

3.2.5
Recommendations
for
Refining
Residential
Postapplication
Risk
Assessments
In
order
to
refine
the
residential
postapplication
assessment,
data
on
actual
use
patterns
including
rates,
timing,
and
the
kinds
of
tasks
performed
are
required
to
better
characterize
Aquashade
risks.

3.3
Residential
Aggregated
Exposure
and
Risk
Estimates
To
better
quantify
residential
Aquashade
hazard,
results
from
residential
handler
and
residential
postapplication
risk
assessments
were
aggregated.
Aggregate
calculations
of
residential
exposure
were
performed
using
worst­
case
MOEs
resulting
from
each
assessment.

The
residential
aggregated
exposure
resulted
in
an
estimated
MOE
of
1700
and,
therefore,
is
not
a
risk
of
concern.
