Document ID: EPA-HQ-OPP-2003-0101-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-03-18T05:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
Office
of
Prevention,
Pesticides
and
Toxic
Substances
March
14,
2003
SUBJECT:
Carbaryl:
Revised
HED
Risk
Assessment
­
Phase
5­
Public
Comment
Period,
Error
Correction
Comments
Incorporated;
DP
Barcode:
D287532,
PC
Code:
056801
FROM:
Jeffrey
L.
Dawson,
Chemist/
Risk
Assessor
Reregistration
Branch
1
Health
Effects
Division
(
7509C)

THRU:
Whang
Phang,
PhD,
Branch
Senior
Scientist
Reregistration
Branch
1
Health
Effects
Division
(
7509C)

TO:
Anthony
Britten,
Chemical
Review
Manager
Reregistration
Branch
3
Special
Review
&
Reregistration
Division
(
7508C)

Attached
is
HED's
risk
assessment
of
the
insecticide
carbaryl
for
purposes
of
issuing
a
Reregistration
Eligibility
Decision
(
RED)
Document
for
this
active
ingredient.
This
document
is
based
on
several
disciplinary
science
chapters
which
include:
Toxicology
­
D282980;
Dietary
Exposure
­
D288479;
Product
and
Residue
Chemistry
­
D283328;
Occupational
and
Residential
Exposure
­
D287251;
and
Estimated
Environmental
Concentrations
­
D288455.
A
response
to
comments
document
was
also
prepared
which
summarizes
and
illustrates
specifically
how
the
comments
were
addressed
for
the
risk
assessment.
Many
elements
of
this
assessment
remain
unchanged
from
the
previous
version.
However,
changes
have
been
made
based
on
comments
and
other
information
received
in
the
interim
by
the
Agency.
No
specific
changes
were
made
related
to
hazard
characterization
except
that
additional
characterization
language
has
been
developed
related
to
several
issues
(
e.
g.,
FQPA
10x
factor)
and
a
rationale
for
use
of
the
short­
term
oral
endpoint
to
calculate
risks
for
the
suburban
biological
monitoring
study
has
been
included.
For
the
dietary
risk
assessment,
the
major
changes
are
updated
percent
crop
treated
values,
use
of
a
water
concentration
distribution
in
the
acute
aggregate
assessment,
and
additional
characterization
language
related
to
use
of
the
carbamate
market
basket
survey.
The
estimated
environmental
concentrations
have
also
been
significantly
altered
to
reflect
input
changes
for
PRZM­
EXAMS.
A
water
monitoring
study
was
also
completed
by
Bayer
which
was
used
only
to
characterize
the
most
recent
water
modeling
results.
In
the
occupational
and
residential
assessments,
transfer
coefficients
were
modified,
headgear
was
considered
for
airblast
applicators,
dog
collar
transferable
residues
were
used,
the
approach
for
pet
products
was
modified,
Residential
Exposure
Joint
Venture
use
data
were
considered,
and
the
results
of
a
large
suburban
resident
biological
monitoring
study
were
included.
This
chapter
also
addresses
the
probabilistic
assessment
which
has
been
submitted
by
Bayer.

Reviewers:
RARC
(
6/
6/
01
Report),
Revision
(
6/
7/
02)
Reviewed
By
Paula
Deschamp
HUMAN
HEALTH
RISK
ASSESSMENT
Carbaryl
U.
S.
Environmental
Protection
Agency
Office
of
Pesticide
Programs
Health
Effects
Division
(
7509C)
Jeffrey
L.
Dawson,
Chemist/
Risk
Assessor
Date:
March
14,
2003
HUMAN
HEALTH
RISK
ASSESSMENT
Carbaryl
Risk
Assessment
Team:

Risk
Assessor:
Jeffrey
L.
Dawson,

Dietary
Risk:
Felecia
Fort
Product
and
Residue
Chemistry:
Felecia
Fort
Occupational
and
Residential
Exposure:
Jeffrey
L.
Dawson
Epidemiology:
Jerome
Blondell,
MPH,
PhD
Monica
Spann,
MPH
Virginia
Dobozy,
VMD,
MPH
Toxicology:
Virginia
Dobozy,
VMD,
MPH
Kit
Farwell,
DVM
Drinking
Water
Estimates:
R.
David
Jones,
Ph.
D.
E.
Laurence
Libelo,
Ph.
D.
Elizabeth
Behl,
Ph.
D.

Statistician:
Steve
Nako,
Ph.
D.

Probabilistic
Assessment
Team:
Bart
Suhre,
M.
S.
Jeff
Evans
William
Smith,
Ph.
D.
Alan
Dixon
Sheila
Piper,
M.
S.
David
Miller,
M.
S.
Steve
Nako,
Ph.
D.
David
Hrdy
Table
of
Contents
1.0
EXECUTIVE
SUMMARY
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5
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION
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22
2.1
Chemical
Structure
and
Identification
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22
2.2
Physical
Properties
of
Carbaryl
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23
3.0
HAZARD
CHARACTERIZATION
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24
3.1
Hazard
Profile
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24
3.2
FQPA
Considerations
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27
3.2.1
Determination
of
Susceptibility
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27
3.2.2
Degree
of
Concern
Analysis
and
Residual
Uncertainties
.
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28
3.3
Dose
Response
Assessment
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29
3.4
Endocrine
Disruption
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31
4.0
NON­
OCCUPATIONAL
RISK
ASSESSMENT
AND
CHARACTERIZATION
.
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31
4.1
Summary
of
Registered
Uses
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32
4.2
Dietary
Risk
Assessment
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36
4.2.1
Residue
Profile
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37
4.2.2
Acute
Dietary
Risk
Assessment
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39
4.2.3
Chronic
Dietary
Risk
Assessment
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42
4.2.4
Cancer
Dietary
Risk
Assessment
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42
4.2.5
Characterization/
Uncertainties
of
the
Dietary
Risk
Estimates
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43
4.3
Estimated
Environmental
Concentrations
In
Water
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43
4.3.1
Environmental
Fate
Characteristics
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43
4.3.2
Monitoring
Data
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44
4.3.3
Modeling
EECs
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45
4.4
Residential
Risk
Assessment
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47
4.4.1
Home
Uses
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48
4.4.2
Deterministic
Residential
Handler
Risk
Assessment
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49
4.4.2.1
Deterministic
Residential
Handler
Noncancer
Risks
(
52)
4.4.2.2
Residential
Handler
Cancer
Risks
(
56)
4.4.3
Deterministic
Residential
Postapplication
Risk
Assessment
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58
4.4.3.1
Deterministic
Residential
Postapplication
Exposure
and
Noncancer
Risks
(
63)
4.4.3.2
Deterministic
Residential
Postapplication
Exposure
and
Risks
For
Cancer
(
70)
4.4.4
Risks
Based
On
Carbaryl
Suburban
Resident
Biomonitoring
Study
.
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71
4.4.4.1
Noncancer
Risks
Based
On
Biological
Monitoring
Data
(
77)
4.4.4.2
Cancer
Risks
Based
On
Biological
Monitoring
Data
(
79)
4.4.5
Residential
Risk
Characterization
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80
4.4.6
Exposure
From
The
Use
of
Tobacco
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84
4.4.7
Other
Residential
Exposures
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85
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
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85
5.1
Calculation
of
Aggregate
Risks
and
DWLOCs
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86
5.2
Acute
Aggregate
Risks
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88
5.3
Chronic
Aggregate
Risks
and
DWLOCs
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89
5.4
Short­
term
Aggregate
Risks
and
DWLOCs
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89
5.5
Intermediate­
term
Aggregate
Risks
and
DWLOCs
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91
5.6
Aggregate
Cancer
Risks
and
DWLOCs
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91
5.7
Summary
of
Non­
Probabilistic
Aggregate
Risks
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92
5.8
Companion
Probabilistic
Aggregate
Risk
Assessment
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93
6.0
CUMULATIVE
RISK
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98
7.0
OCCUPATIONAL
RISK
ASSESSMENT
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98
7.1
Occupational
Handler
Risk
Assessment
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99
7.1.1
Occupational
Handler
Non­
Cancer
Risks
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104
7.1.2
Occupational
Handler
Cancer
Risks
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108
7.2
Postapplication
Exposures
and
Risks
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112
7.2.1
Occupational
Postapplication
Noncancer
Risks
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116
7.2.2
Occupational
Postapplication
Exposure
and
Risk
Estimates
for
Cancer
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118
7.3
Occupational
Risk
Characterization
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121
8.0
HUMAN
AND
DOMESTIC
ANIMAL
INCIDENT
DATA
REVIEW
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125
9.0
DATA
NEEDS
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126
APPENDIX
1:
Toxicology
Profile
APPENDIX
2:
Incident
Review
5
1.0
EXECUTIVE
SUMMARY
The
Health
Effects
Division
(
HED)
of
EPA's
Office
of
Pesticide
Programs
has
evaluated
the
carbaryl
database
and
conducted
a
human
health
risk
assessment
for
the
reregistration
of
the
chemical.
Carbaryl
is
a
list
A
reregistration
chemical
and
is
also
subject
to
court
specified
deadlines
resulting
from
a
Natural
Resources
Defense
Council
(
NRDC)
petition
of
the
Agency.
This
assessment
incorporates
error
corrections
and
begins
phase
5
of
the
public
participation
process.
The
principal
registrant
for
carbaryl
is
Bayer
CropSciences
Corporation,
hereafter
referred
to
as
Bayer.

Use
Patterns:

Carbaryl
[
1­
napthyl
methylcarbamate]
is
one
of
the
most
widely
used
broadspectrum
insecticides
in
agriculture,
professional
turf
management,
professional
ornamental
production,
and
in
the
residential
pet,
lawn,
and
garden
markets.
Carbaryl
formulations
include
baits,
dusts,
pet
collars,
flowable
concentrates,
emulsifiable
concentrates,
granulars,
soluble
concentrates,
and
wettable
powders.
Carbaryl
is
used
in
agriculture
to
control
pests
on
terrestrial
food
crops
including
fruit
and
nut
trees
(
e.
g.,
apples,
pears,
almonds,
walnuts,
and
citrus),
many
types
of
fruit
and
vegetables
(
e.
g.,
cucumbers,
tomatoes,
lettuce,
blackberries,
and
grapes),
and
grain
crops
(
e.
g.,
corn,
rice,
sorghum,
and
wheat).
Carbaryl
is
also
used
for
direct
animal
treatments
to
control
pests
on
companion
animals
such
as
dogs
and
cats.
There
are
other
uses
for
ornamentals
and
turf,
including
production
facilities
such
as
greenhouses,
golf
courses,
and
residential
sites
that
can
be
treated
by
professional
applicators
(
e.
g.,
annuals,
perennials,
shrubs).
Carbaryl
can
also
be
used
by
homeowners
on
lawns,
for
home
and
garden
uses,
and
on
companion
animals.
There
are
no
labels
for
indoor
uses
within
a
residence.
In
agriculture,
groundboom,
airblast,
and
aerial
applications
are
typical.
Other
applications
can
also
be
made
using
handheld
equipment
such
as
low
pressure
handwand
sprayers,
backpack
sprayers,
and
turfguns.
Homeowners
can
also
use
other
types
of
application
equipment
including
trigger
sprayers,
hose­
end
sprayers,
and
ready­
to­
use
dust
packaging.
Carbaryl
also
has
more
specialized
uses
that
can
lead
to
exposures
in
the
general
population
such
as
an
adulticide
for
mosquito
control,
for
grasshopper
control
by
USDA/
APHIS,
and
for
Ghost
and
Mud
shrimp
control
in
oyster
beds
in
Washington
State.
These
more
specialized
use
patterns
were
also
considered
in
this
assessment
as
were
the
timing
of
applications
based
on
the
emergence
of
various
pest
complexes.

Exposure
Data:

Many
types
of
carbaryl­
specific
data
were
considered
in
the
development
of
this
assessment
related
to
exposure
through
the
diet,
from
drinking
water,
and
in
occupational
or
residential
settings.
Use
data
were
available
that
refined
various
exposure
factors
in
the
assessment.
These
included
the
Sevin
User
Survey
completed
by
Bayer
and
the
Residential
Exposure
Joint
Venture
survey
of
residential
pesticide
users.
For
dietary
exposures,
many
sources
of
data
were
used
including:
updated
(
2002)
percent
crop
treated
values;
various
processing
factors;
1994
to
1998
CSFII
results
(
Continuing
Survey
of
Food
Intake
By
Individuals);
and
many
sources
of
residue
data
that
included
crop
field
trials,
data
from
FDA's
monitoring
program,
USDA's
Pesticide
Data
Program,
and
a
carbamate
market
basket
survey
(
CMBS).
For
drinking
water
exposures,
estimated
environmental
concentrations
(
EECs)
are
based
on
model
estimates.
Current
EECs
reflect
the
latest
information
pertaining
to
the
fate
characteristics
of
carbaryl
in
the
environment
(
i.
e.,
many
new
sources
of
residue
dissipation
data
are
reflected
in
the
current
assessment).
A
water
monitoring
study
was
also
completed
by
Bayer
but
not
6
used
quantitatively
due
to
site
selection
and
sample
frequency
concerns.
NAWQA
data
for
carbaryl
were
also
considered
for
similar
purposes
because
it
is
frequently
detected.
Many
sources
of
data
were
used
to
calculate
the
occupational
and
residential
risks
associated
with
the
use
of
carbaryl.
To
address
occupational
exposures,
several
scenario­
specific
handler
exposure
studies
were
used
(
e.
g.,
trigger
sprayer,
commercial
pet
groomers,
and
granular
backpack
users).
Dislodgeable
foliar
residue
studies
on
several
crops
and
a
turf
transferable
residue
study
were
also
used.
In
addition,
preliminary
results
from
a
biological
monitoring
study
on
tree
fruit
thinners
and
harvesters
were
used
to
characterize
postapplication
exposures
for
similar
activities.
To
address
residential
exposures,
the
dislodgeable
foliar
and
turf
transferable
residue
studies
were
also
used,
a
study
that
quantified
transferable
residues
from
dogs
wearing
pet
collars
was
used,
the
Residential
Exposure
Joint
Venture
information
was
used,
and
the
results
from
a
suburban
resident
biological
monitoring
study
were
used.
It
should
also
be
noted
data
from
several
population­
based
exposure
studies
(
e.
g.,
NHEXAS
&
NHANES)
were
used
for
comparative
purposes
to
further
describe
and
characterize
the
results
of
this
assessment.
Finally,
a
probabilistic
aggregate
assessment
using
the
CARES
model
was
submitted
which
is
also
addressed.

Hazard
Characterization:

Carbaryl
is
a
carbamate
insecticide
where
the
mode
of
toxic
action
is
through
cholinesterase
inhibition
(
ChEI).
In
most
of
the
toxicology
studies
in
which
ChEI
activity
was
measured,
it
was
the
endpoint
used
for
setting
the
No
Observed
Adverse
Effect
Level
(
NOAEL)
for
risk
assessment,
the
dose
at
which
no
adverse
effects
were
observed.
For
chronic
duration
exposures,
a
NOAEL
could
not
be
defined
in
the
toxicology
study
so
a
Lowest
Observed
Adverse
Effect
Level
(
LOAEL),
the
lowest
dose
where
the
first
adverse
effects
were
observed,
was
selected.

The
Agency
is
required
by
the
Food
Quality
Protection
Act
to
consider
the
special
sensitivities
of
various
susceptible
populations
such
as
infants
and
children.
Dietary
exposures
were
calculated
using
FDA
and
PDP
monitoring
data,
a
carbamate
market
basket
survey
(
CMBS),
and
percent
crop
treated
information.
Residential
exposures
were
calculated
using
a
number
of
carbaryl­
specific
studies.
In
the
toxicology
database,
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
in
rat
or
rabbit
fetuses
following
in
utero
exposure
in
the
standard
developmental
toxicity
studies
was
observed.
There
was
a
low
level
of
concern
for
evidence
of
susceptibility
seen
in
the
developmental
neurotoxicity
study,
and
there
was
evidence
of
increased
susceptibility
in
offspring
in
the
2­
generation
reproduction
study.
For
carbaryl,
a
safety
factor
of
3x
was
applied
to
chronic
duration
exposures
to
account
for
the
lack
of
a
NOAEL
in
the
selected
chronic
dog
toxicity
study
(
i.
e.,
the
use
of
a
LOAEL).
The
Agency
decided
that
the
FQPA
Safety
Factor
should
be
reduced
to
1x
for
other
durations
of
exposure
and
that
this
was
adequate
to
protect
susceptible
populations
because
there
are
no
residual
uncertainties
in
the
exposure
databases,
the
toxicology
database
is
complete,
and
the
endpoints
and
NOAELs
for
risk
assessment
were
well
defined,
and
the
acute
and
chronic
RfDs
would
be
protective
of
these
effects
so
the
special
FQPA
safety
factor
was
reduced
to
1x.

Carbaryl
has
been
classified
as
a
Group
C
possible
human
carcinogen
based
on
an
increased
incidence
of
hemangiosarcomas
and
combined
hemangiomas/
hemangiosarcomas
in
CD­
1
mice
at
100
ppm
and
above
(
15
mg/
kg/
day).
A
linear
low
dose
extrapolation
approach
was
used
for
risk
assessment;
the
Q1*
is
8.75
x
10­
4
(
mg/
kg/
day)­
1
based
on
the
mouse
vascular
tumors.

Endpoints
for
acute
and
chronic
dietary
exposure
risk
assessments
were
selected
by
the
HED
7
Hazard
Identification
Assessment
Review
Committee
(
HIARC).
The
dose
level
used
for
the
acute
dietary
risk
assessment
was
a
NOAEL
from
a
developmental
neurotoxicity
study
conducted
with
rats
(
1
mg/
kg/
day).
The
dose
level
used
for
the
chronic
dietary
risk
assessment
was
a
LOAEL
which
was
defined
in
a
chronic
dog
feeding
study
(
3.1
mg/
kg/
day).
Because
a
NOAEL
could
not
be
defined
in
the
chronic
study,
an
additional
factor
of
3x
was
added
to
the
customary
100x
factor
(
i.
e.,
10x
for
interspecies
extrapolation
and
10x
for
intraspecies
variation)
to
account
for
the
uncertainty
associated
with
a
lack
of
a
NOAEL.
The
acute
and
chronic
reference
doses
(
RfD)
were
0.01
mg/
kg/
day
(
i.
e.,
1/
100
for
the
acute
RfD
and
3.1/
300
for
the
chronic
RfD).

There
are
many
potential
ways
people
can
be
exposed
to
carbaryl
in
occupational
and
residential
settings.
The
Agency
considers
exposures
for
those
involved
in
the
application
of
carbaryl
(
i.
e.,
handlers)
and
those
who
can
come
into
contact
with
carbaryl
residues
after
application
(
i.
e.,
reentry
or
postapplication).
Both
cancer
and
non­
cancer
risk
assessments
were
conducted
for
residential
handlers
and
for
people
in
the
general
population
who
might
be
exposed
postapplication
from
lawn,
garden,
or
pet
uses
of
carbaryl
or
from
more
specialized
uses
such
as
mosquito
adulticide
applications
and
uses
on
oyster
beds
in
Washington
state.
Similarly,
both
handler
and
postapplication
risks
were
calculated
for
those
people
who
could
be
exposed
as
part
of
their
jobs
such
as
a
grower
treating
their
crop
or
someone
harvesting
fruit.
Endpoints
for
occupational
and
residential
exposures
from
various
routes
(
i.
e.,
dermal,
inhalation,
and
incidental
oral)
and
differing
durations
(
i.
e.,
short­
term,
intermediate­
term,
and
chronic)
were
selected
by
the
HIARC.
[
Note:
The
Agency
completed
residential
assessments
based
on
standard
deterministic
approaches
and
based
on
the
recent
suburban
resident
biological
monitoring
study.
Each
analysis
demanded
slightly
different
use
of
the
hazard
data
as
described
below.]
Based
on
current
policy,
short­
term
exposure
was
defined
as
1
to
30
days,
intermediate­
term
exposures
as
30
days
to
six
months,
and
chronic
exposures
as
six
months
to
a
lifetime.
[
Note:
Not
all
routes
and
durations
are
applicable
to
each
population.]
The
toxicity
endpoints
selected
for
these
carbaryl
risk
assessments
are
again
based
on
neurotoxic
effects
associated
with
the
inhibition
of
ChEI.
The
short­
and
intermediateterm
dermal
risk
assessments
for
carbaryl
are
based
on
NOAEL
of
20
mg/
kg/
day
defined
in
a
rat
dermal
toxicity
study
using
technical
material
where
decreases
in
red
blood
cell
cholinesterase
in
males
and
females
and
brain
cholinesterase
in
males
were
observed.
The
short­
term
inhalation
and
nondietary
ingestion
risk
assessments
for
carbaryl
are
based
on
a
NOAEL
of
1
mg/
kg/
day
which
was
defined
in
a
rat
developmental
neurotoxicity
study
where
alterations
in
FOB
measurements
and
cholinesterase
inhibition
(
plasma,
whole
blood,
and
brain)
were
observed.
This
value
was
also
used
to
calculate
risks
from
the
suburban
resident
biomonitoring
study
because
it
eliminated
route­
to­
route
extrapolation;
the
dose
values
from
the
study
could
be
attributed
to
various
exposure
routes;
oral
absorption
is
fast
and
essentially
quantitative;
and,
when
adjusted
for
absorption,
the
effective
NOAEL
from
the
dermal
toxicity
study
is
similar
to
that
observed
in
the
oral
study.
The
intermediate­
term
inhalation
and
nondietary
ingestion
risk
assessments
are
based
on
a
NOAEL
of
1
mg/
kg/
day
that
was
defined
in
a
subchronic
neurotoxicity
study
in
rats.
The
chronic
risk
assessments,
regardless
of
how
exposures
occur
(
e.
g.,
skin
or
inhaled)
are
based
on
a
LOAEL
of
3.1
mg/
kg/
day
that
was
defined
in
a
1
year
dog
feeding
study.
In
some
assessments,
a
dermal
absorption
factor
is
required.
A
rat
dermal
absorption
study
using
radiolabeled
14C
carbaryl
was
used
to
define
a
factor
of
12.7
percent;
this
value
was
used
to
calculate
the
1
At
the
present
time,
information
from
the
industry­
sponsored
Carbamate
Market
Basket
Survey
has
been
approved
for
use
in
dietary
risk
assessments
with
appropriate
characterization
of
uncertainties
associated
with
the
conduct
of
the
study.
The
primary
concern
was
rubbing
sampled
commodities
during
the
rinsing
process
except
for
broccoli
and
tomato
because
this
created
a
potential
for
residue
loss
from
the
mechanical
action
associated
with
rubbing.
A
separate
assessment
was
also
completed
using
other
sources
of
high
quality
residue
data
(
e.
g.,
PDP)
for
comparative
purposes
to
more
completely
inform
the
risk
management
process.

8
oral
equivalent
dermal
dose
for
noncancer
chronic
duration
exposures
and
for
the
calculation
of
cancer
risks.
No
inhalation
toxicity
studies
were
available
for
risk
assessment
purposes
so
a
route­
to­
route
extrapolation
was
used
to
address
risks
from
inhalation
exposures.
Absorption
via
the
inhalation
route
is
presumed
to
be
equivalent
to
oral
absorption.

Carbaryl
is
a
reversible
inhibitor
of
acetylcholine
esterase.
In
an
acute
time­
course
study,
following
a
single
gavage
dose
of
carbaryl,
brain
cholinesterase
inhibition
had
returned
to
pre­
treatment
values
by
8
hours
in
the
10
mg/
kg
group,
by
24
hours
in
the
30
mg/
kg
group,
and
by
48
hours
in
the
90
mg/
kg
group.
No
cumulative
effects
were
shown
in
a
subchronic
neurotoxicity
feeding
study,
cholinesterase
inhibition
was
similar
when
determined
at
week
4,
8,
or
13.

Dietary
Risk
Estimates:

Potential
dietary
exposure
to
carbaryl
occurs
through
food
and
water
although
this
section
addresses
food
only
consumption.
Food
and
water
consumption
combined
(
i.
e.,
aggregate
exposures)
are
addressed
below.
Tolerances
for
residues
of
carbaryl
are
currently
expressed
in
terms
of
carbaryl
and
its
hydrolysis
product,
1­
naphthol
(
calculated
as
carbaryl)
for
most
raw
agricultural
commodities.
However,
HED
is
recommending
that
carbaryl
per
se
be
regulated
in
plants.
In
livestock
commodities,
carbaryl;
5,6­
dihydro­
5,6­
dihydroxy
carbaryl;
and
5­
methoxy­
6­
hydroxy
carbaryl
and
all
residues
which
can
be
hydrolyzed
to
carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl,
or
5­
methoxy­
6­
hydroxy
carbaryl
under
acidic
conditions
should
be
included
in
the
tolerance
expression
and
risk
assessment
for
all
endpoints
of
dietary
concern.
Once
the
tolerances
for
plants
are
revised,
they
will
be
compatible
with
Codex
MRLs
except
for
livestock
commodities.

A
Tier
3/
4
dietary
risk
assessment,
which
is
the
most
highly
refined
assessment
possible
at
this
time,
was
conducted.
Both
acute
and
chronic
dietary
risk
assessments
were
conducted.
Dietary
exposure
was
determined,
considering
the
level
of
carbaryl
residue
on
food
commodities
and
their
potential
consumption
by
multiple
subpopulations.
Dietary
risk
was
then
calculated
by
comparing
dietary
exposure
to
the
acute
or
chronic
PADs.
Data
on
anticipated
carbaryl
residues
were
determined
based
mainly
on
USDA
Pesticide
Data
Program
(
PDP)
and
Food
and
Drug
Administration
(
FDA)
monitoring
data.
Field
trial
data
were
used
for
certain
commodities.
In
addition,
separate
acute
analysis
was
conducted
incorporating
the
results
of
the
Carbamate
Market
Basket
Survey
(
CMBS).
1
The
percentage
of
the
crop
treated
(
estimated
maximum
percentage
and
weighted
average
percentage
for
the
acute
and
chronic
analyses,
respectively)
was
also
considered.
Carbaryl
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
The
1994­
96,
98
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
nonconsecutive
survey
days.
Foods
"
as
consumed"
(
e.
g.,
apple
pie)
are
linked
to
EPA­
defined
food
9
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
N/
S;
baked;
or
wheat
flour
­
cooked;
fresh
or
N/
S,
baked)
using
publicly
available
recipe
translation
files
developed
jointly
by
USDA/
ARS
and
EPA.
Consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.
Values
greater
than
100
percent
of
the
PAD
exceed
HED's
level
of
concern.

Estimated
acute
dietary
exposure
(
again,
water
is
not
included)
for
carbaryl
at
the
99.9th
percentile
is
below
the
level
of
concern
for
all
population
subgroups
regardless
of
the
data
set
used.
The
results
of
the
acute
dietary
assessment
when
CMBS
data
have
not
been
used
indicate
risks
estimates
are
43%
and
94%
for
the
general
U.
S
population
and
children
(
1­
2
years
old),
the
highest
exposed
population
subgroup,
respectively.
When
CMBS
data
were
incorporated,
the
highest
exposed
subpopulation
was
children
(
1­
2
years
old)
at
86
percent
of
the
aPAD.
A
sensitivity
analysis
was
completed
by
the
Agency
(
not
using
the
CMBS)
to
evaluate
the
impacts
of
eliminating
strawberries.
Eliminating
strawberries
has
the
most
impact
as
risk
estimates
for
children
(
1­
2
years
old)
occupied
71
percent
of
the
aPAD.

Estimated
chronic
dietary
risks
for
all
population
subgroups
are
not
of
concern.
Estimated
chronic
dietary
exposures
for
all
population
subgroups
resulted
in
<
1
percent
of
the
cPAD
being
occupied.

The
cancer
dietary
exposure
assessment
was
conducted
using
the
Q
1*
approach
(
i.
e.,
linear,
low
dose
extrapolation).
Dietary
exposure
is
determined
from
consumption
and
residue
data,
as
was
done
for
the
acute
and
chronic
dietary
assessments.
The
food
exposure
is
then
multiplied
by
the
Q
1*
(
8.75
x
10­
4)
(
mg/
kg/
day)­
1
for
carbaryl
to
determine
the
increased
risk
of
cancer
from
consuming
carbaryl
residues
in
food
over
a
lifetime
(
70
years).
Risks
estimates
above
1
x
10­
6
are
of
concern.
Results
indicate
a
maximum
lifetime
risk
of
2.14
X
10­
8
for
the
general
US
population.

Concentrations
in
Water:

Monitoring
data
(
NAWQA
&
a
Bayer
monitoring
study)
for
carbaryl
residues
in
ground
and
surface
water
are
available,
but
they
are
of
limited
utility
in
developing
estimated
environmental
concentrations
(
EECs)
for
risk
assessment.
The
key
issues
with
using
Bayer's
surface
water
monitoring
study
were
the
number
of
sites
were
limited
and
therefore
the
vulnerability
of
the
selected
sites
was
questionable.
Samples
were
also
collected
too
infrequently
to
ensure
that
peak
concentrations
were
captured.
As
a
result,
computer
modeling
was
used
to
estimate
surface
(
PRZM
3.12
and
EXAMS
2.98.04)
and
ground
(
SCI­
GROW
2.2)
water
concentrations
expected
from
normal
agricultural
use.
For
the
acute
dietary
calculation,
the
distribution
of
modeled
surface
water
concentrations,
which
were
output
from
PRZM/
EXAMS,
were
integrated
into
the
probabilistic
assessment
in
a
manner
analogous
to
data
for
any
other
commodity.
For
the
other
types
of
assessments,
the
model
estimates
(
i.
e.,
otherwise
known
as
Estimated
Environmental
Concentrations
or
EECs)
were
compared
to
drinking
water
levels
of
concern
(
DWLOCs),
the
theoretical
concentration
of
pesticide
in
drinking
water
that
would
be
an
acceptable
upper
limit
in
light
of
the
aggregate
exposure
to
that
pesticide
from
other
sources
(
food
and
residential
use).
The
maximum
calculated
acute
and
chronic
surface
water
EECs
(
316
ppb
and
14.2
ppb,
respectively)
resulted
from
use
on
citrus
in
Florida.
In
Florida,
the
majority
of
drinking
water
is
derived
from
groundwater
(>
90%)
so
high
surface
water
concentrations
do
not
necessarily
indicate
high
exposure.
As
a
result,
both
Florida
and
the
results
for
Pennsylvania
apples
and
sweetcorn
in
Ohio
(
the
10
next
highest
EECs
for
acute
and
chronic
exposures,
respectively)
have
also
been
considered
(
62.9
ppb
for
acute
and
5.53
ppb
for
chronic
exposures,
respectively).
Groundwater
EECs
for
the
acute
and
chronic
assessments
were
both
0.8
ppb
as
calculated
with
SCI­
GROW.

Use
of
Consumer
Products
(
Residential
Handler
Risks
Based
On
Deterministic
Approaches):

Combined
(
dermal
and
inhalation)
risks
were
calculated
for
17
scenarios
(
i.
e.,
52
site/
area/
rate
combinations
within
those
scenarios)
considered
representative
of
the
residential
uses
of
carbaryl.
Noncancer
MOEs
associated
with
most
scenarios
(
40
of
52
considered)
are
generally
not
of
concern
because
they
exceed
the
Agency's
uncertainty
factors
for
noncancer
risk
assessments
(
i.
e.,
MOE
$
100).
The
scenarios
of
concern
involve
the
use
of
dusts
(
in
gardens
and
on
pets)
and
for
some
liquid
sprays
on
gardens.
Cancer
risks
were
also
calculated
for
a
single
day
of
use
then
the
allowable
annual
number
of
days
exposure
was
defined
based
on
a
cancer
risk
limit
of
1x10­
6.
Based
on
a
single
day
of
exposure,
cancer
risks
for
most
scenarios
are
in
the
10­
8
to
10­
10
range
although
there
is
one
scenario
where
the
risks
slightly
exceed
1x10­
6
(
dusting
dogs
=
1.09x10­
6)
even
for
a
single
day
of
use.
It
should
be
noted
that
there
are
5
scenarios
where
the
allowable
days
per
year
of
exposure
is
less
than
or
equal
to
5
which
should
be
considered
in
conjunction
with
the
Sevin
User
Survey
data
from
Bayer
that
indicates
5
uses
per
year
is
the
84th
percentile.
The
database
for
carbaryl
is
fairly
complete
compared
to
many
other
chemicals.
Recent,
high
quality
data
generated
by
the
Bayer
Corporation,
the
ORETF
(
Outdoor
Residential
Exposure
Taskforce,
Bayer
is
a
member),
and
the
Wellmark
Corporation
have
been
used
to
address
the
key
residential
uses
of
carbaryl
on
lawns,
flower
and
vegetable
gardens,
and
pets.
Use
and
usage
inputs
from
the
recent
Residential
Exposure
Joint
Venture
survey
of
pesticide
users
also
appear
to
be
essentially
consistent
with
the
use
information
provided
by
the
Bayer
Corporation
at
the
1998
SMART
meeting.
No
key
data
gaps
have
been
identified
by
the
Agency
at
this
time
for
residential
handlers.
However,
it
is
likely
that
there
are
scenarios
that
remain
unaddressed
by
the
Agency
at
this
time
due
to
a
lack
of
data
or
other
meta
information.
The
Agency
will
address
other
appropriate
scenarios
as
they
are
identified.
The
results
of
this
deterministic
assessment
should
also
be
considered
in
conjunction
with
the
assessments
completed
based
on
the
biological
monitoring
study
and
the
probabilistic
aggregate
calculations
using
the
CARES
model
described
below.

Residential
Exposures
(
Postapplication
Risks
Based
On
Deterministic
Approaches):

HED
considered
a
number
of
residential
postapplication
exposure
scenarios
for
toddlers,
youthaged
children
and
adults.
Short­
term
and
intermediate­
term
risks
from
declining
residues
were
calculated
for
multiple
scenarios,
including
exposures
to
treated
lawns
(
toddlers
and
adults),
golf
courses
(
adults),
gardens
(
adults
and
youth­
aged
children)
and
pets
(
toddlers).
Exposures
from
more
limited
uses
such
as
a
mosquito
adulticide
and
in
oyster
beds
were
also
considered.
Short­
term
MOEs
were
calculated
based
on
the
residue
concentrations
for
each
day
while
intermediate­
term
risks
were
calculated
using
a
30
day
average
based
on
residue
decline.
The
Agency
has
short­
term
risk
concerns
for
exposures
to
adults
doing
heavy
yardwork,
for
toddlers
playing
on
treated
lawns,
and
for
toddlers
that
have
contact
with
treated
pets
(
except
those
treated
with
collars).
Activities
associated
with
home
gardening
(
e.
g.,
harvesting)
and
golfing
for
adults,
children
in
contact
with
pets
wearing
collars,
home
gardening
for
youth­
aged
children
or
any
age
or
activity
considered
in
the
mosquito
adulticide
or
oyster
bed
assessments
do
not
have
risk
concerns
even
on
the
day
of
application
(
i.
e.,
MOEs
$
100
on
the
day
of
application).
For
adults,
the
MOEs
for
heavy
yardwork
do
not
meet
or
exceed
risk
targets
(
i.
e.,
MOE
$
100)
up
to
5
days
after
application.
For
toddlers,
the
Agency
has
concerns
for
pet
treatments
and
also
11
for
lawn
uses.
In
fact,
pet
uses
(
except
for
collars)
never
reach
acceptable
levels
even
30
days
after
application
and
not
until
18
days
at
the
maximum
application
rate
considered
on
turf.
Toddler
MOEs
from
pet
and
turf
uses
represent
total
exposures
from
multiple
pathways.
For
the
pet
uses,
dermal
and
hand­
to­
mouth
exposures
essentially
both
equally
contribute
to
the
overall
estimate.
For
the
turf
uses,
dermal
and
hand­
to­
mouth
exposures
are
also
the
key
contributors
to
the
overall
estimates.
The
Agency
does
not
have
intermediate­
term
risk
concerns
for
adults
and
youth­
aged
children
for
any
of
the
uses
considered
including
lawncare,
home
gardens,
golfing,
and
any
aspect
of
adulticide
mosquito
control
or
uses
in
oyster
beds.
In
contrast,
the
Agency
does
have
intermediate­
term
risk
concerns
for
all
toddler
exposure
scenarios
considered
(
i.
e.,
non
collar
pet
treatments
and
lawncare
uses).
As
with
the
shortterm
MOEs,
pet
and
turf
uses
represent
total
exposures
where
the
significant
contributions
to
overall
exposures
are
again
made
equally
from
the
dermal
and
hand­
to­
mouth
exposures.

Cancer
risks
were
also
considered
for
adults
in
residential
settings.
In
all
cases,
the
cancer
risks
were
not
the
predominant
concern.
Risks
did
not
exceed
1x10­
6
on
the
day
of
application
for
any
scenario
considered.
All
postapplication
cancer
risks
were
calculated
based
on
an
annual
frequency
of
1
exposure
per
year.
It
is
likely
that
additional
events
could
occur
but
data
linking
postapplication
activities
and
carbaryl
use
patterns
are
not
available.
To
address
this
issue,
the
Agency
calculated
the
number
of
exposures
that
can
occur
under
a
cancer
risk
ceiling
of
1x10­
6
and
determined
that
from
20
days
per
year
to
exposures
every
day
of
the
year
could
occur
under
the
risk
ceiling
depending
upon
the
scenario.
The
results
of
this
deterministic
assessment
should
also
be
considered
in
conjunction
with
the
assessments
completed
based
on
the
suburban
resident
biological
monitoring
study
and
the
probabilistic
aggregate
calculations
using
the
CARES
model
described
below.

Residential
Risks
Calculated
Based
On
Suburban
Resident
Biological
Monitoring
Study
The
suburban
resident
biological
monitoring
study
for
carbaryl
has
been
used
by
the
Agency
to
examine
the
exposure
patterns
and
associated
risks
that
can
occur
in
households
where
the
lawn
and
gardens
or
ornamentals
have
been
treated.
The
results
of
this
study
should
be
considered
in
conjunction
with
the
results
of
the
deterministic
assessments
described
above
and
the
probabilistic
aggregate
assessment
completed
using
the
CARES
model
described
below.
The
biomonitoring
study
quantified
absorbed
dose
levels
of
carbaryl
in
106
people
in
23
households
in
California
and
Missouri.
Lawns
were
treated
at
each
residence.
Additionally
gardens
or
ornamental
plants
were
also
treated
at
each
residence.
Based
on
use
information,
the
population
which
was
monitored
in
the
study
could
be
construed
to
represent
a
population
which
has
the
highest
possible
potential
for
exposure
associated
with
it
because
of
the
concurrent
applications
to
different
areas
(
i.
e.,
in
all
cases
lawns
and
another
area
was
treated).
However,
the
Agency
believes
that
the
lawn
use
was
the
key
contributor
to
overall
exposures
which
should
be
considered
when
interpreting
the
associated
risks.
The
Residential
Exposure
Joint
Venture
use
survey
results
should
also
be
considered
when
interpreting
the
results
of
this
study.
This
survey
indicates
that
about
1.2
percent
of
the
general
population
uses
carbaryl
on
lawns
and
those
who
also
concurrently
use
it
on
vegetables
and
ornamentals
represent
at
most
0.18
and
0.44
percent
of
the
general
12
population,
respectively.
It
should
also
be
noted
that
about
50
percent
of
the
1.2
percent
of
lawn
users
in
the
general
population
use
carbaryl
for
spot
treatments
only
which
would
not
likely
lead
to
significant
exposures.

The
Agency
placed
individuals
into
likely
groups
for
its
analysis
that
included
applicators,
nonapplicator
adults,
and
children
of
various
age
brackets.
There
are
different
possible
methods
for
calculating
risks
from
this
study
because
of
the
random
nature
of
the
exposure
patterns
and
what
the
pharmacokinetics
analysis
determined
about
the
excretion
profile
for
carbaryl.
Because
of
this,
the
Agency
considered
a
number
of
possible
approaches
for
evaluating
the
data
in
conjunction
with
this
information
about
pharmacokinetics.
The
Agency
recommended
an
approach
in
which
post­
application
total
dose
values
were
used
to
calculate
risk
estimates
(
i.
e.,
daily
outputs
were
added
together
since
the
study
monitored
residues
for
96
hours
after
application
which
is
the
time
it
takes
for
single
carbaryl
dose
to
be
eliminated
from
the
body)
with
the
knowledge
that
this
approach
could
overestimate
exposure
if
multiple
exposure
events
occurred
early
in
the
monitoring
period.
It
should
be
noted,
however,
that
if
the
key
exposure
events
occurred
later
in
the
monitoring
period
that
the
total
value
could
underestimate
exposure
due
to
incomplete
sample
collection.
The
Agency
also
used
the
data
in
the
same
manner
as
Bayer
which
calculated
risks
based
on
individual
daily
dose
values,
not
corrected
for
mass
balance.
This
approach
would
be
more
likely
to
underestimate
dose
based
on
what
is
known
about
the
pharmacokinetics
and
excretion
profile
for
carbaryl.

It
is
clear
that
the
manner
in
which
noncancer
risks
were
calculated
has
an
impact
on
the
resulting
risks
(
i.
e.,
total
versus
daily
dose).
For
both
techniques,
however,
the
Agency
has
a
concern
(
i.
e.,
MOEs<
100)
at
the
upper
percentiles
of
exposure
for
adults
and
children
alike
regardless
of
how
the
risks
were
calculated
(
e.
g.,
95th
%
tile
and
up).
In
the
Agency's
approach,
risks
are
also
of
concern
based
on
whatever
measure
of
central
tendency
is
considered
for
all
populations
(
MOEs
~
10
to
70)
except
for
the
oldest
children
and
non­
applicator
adults.
If
single
day
values
are
considered,
risks
are
not
of
concern
based
on
geometric
means
but
are
of
concern
if
the
arithmetic
mean
is
considered
for
children
under
10
years
of
age
(
MOEs
~
50
to
90).
Risks
are
of
most
concern
for
applicators
and
the
youngest
children
because
they
had
the
most
opportunity
for
exposure
(
i.
e.,
applicators
were
in
proximity
to
product
and
young
children
spent
the
most
time
outdoors
on
treated
lawns).
Additionally,
it
should
be
noted
that
cancer
risks
are
not
a
concern
compared
to
the
noncancer
risk
estimates
as
with
the
deterministic
assessments.
The
distributions
of
absorbed
dose
in
this
study
were
also
compared
to
those
in
the
corresponding
deterministic
assessments
which
are
intended
to
represent
screening
level,
upper
percentile
exposures.
In
fact,
the
dose
estimates
calculated
in
the
deterministic
assessments
are
similar
to
those
determined
in
this
study
at
the
upper
percentiles
of
exposure.
The
biological
monitoring
data
were
also
compared
to
several
population­
based
monitoring
studies
(
e.
g..,
NHEXAS
and
NHANES).
This
analysis
indicates
that
central
tendency
values
and
the
upper
percentiles
were
similar
to
results
seen
in
these
studies.
This
can
be
used
to
illustrate
that
exposures
which
are
of
a
risk
concern
can
occur
in
the
general
population
and
that
the
deterministic
risk
assessment
approaches
are
in
fact
screening
level
in
nature
as
their
estimates
approximate
the
upper
percentile
of
the
monitored
populations.

In
summary,
the
biological
monitoring
study
clearly
illustrates
that
exposures
leading
to
risks
of
concern
for
applicators
and
younger
children
can
occur
in
households
where
carbaryl
is
used.
Additionally,
risks
are
of
concern
at
the
highest
percentiles
of
exposure
(
95th
%
tile
and
up)
regardless
of
how
dose
estimates
are
calculated.
If
the
Agency
approach
for
calculating
total
dose
is
considered,
risks
13
at
the
central
tendency
are
also
of
concern.
If
the
Bayer
approach
for
calculating
risks
based
on
single
day
dose
values
is
considered,
risks
are
not
of
concern
based
on
geometric
means
but
it
should
be
kept
in
mind
that
this
approach
does
not
account
for
mass
balance
as
defined
in
the
pharmacokinetic
analysis
of
the
excretion
profile
for
carbaryl.

Aggregate
Risks
and
DWLOCs:

The
Food
Quality
Protection
Act
requires
that
the
Agency
consider
aggregate
risk
for
each
chemical
(
i.
e.,
all
sources
of
exposure
including
food
water,
and
residential
are
considered
in
total).
Aggregate
risks
are
typically
calculated
by
considering
food
or
food
and
residential
(
depends
upon
the
specific
scenario),
subtracting
these
from
the
allowable
exposure
limit,
and,
if
the
exposure
limit
has
not
been
exceeded,
then
calculating
Drinking
Water
Levels
of
Concern
(
DWLOCs)
to
compare
to
surface
or
groundwater
Estimated
Environmental
Concentrations
(
EECs).
If
EECs
exceed
the
DWLOCs
(
i.
e.,
the
allowable
concentrations)
then
there
is
a
risk
concern.
Conversely,
if
EECs
don't
exceed
the
DWLOCs
then
there
is
not
a
risk
concern.
The
aggregate
assessment
for
carbaryl
is
also
groundbreaking
in
that
it
relies
on
the
Agency's
standing
policies
for
these
assessments
but
it
includes
the
first
acute
aggregate
assessment
where
a
water
concentration
distribution
from
PRZM/
EXAMS
has
been
directly
integrated
into
DEEM/
FCID.
In
essence,
the
data
for
water
were
treated
as
the
data
would
be
for
any
food
commodity.
As
such,
DWLOCs
have
been
calculated
for
all
scenarios
except
the
acute
aggregate
assessment.
In
fact,
the
results
for
the
acute
assessment
have
been
presented
like
a
food
only
assessment
using
the
99.9th
%
tile
as
level
of
concern.
Results
for
additional
percentiles
of
exposure
have
also
been
presented
to
allow
for
a
more
informed
risk
management
decision.

The
remaining
assessments
were
completed
using
the
Agency's
standard
DWLOC/
EEC
approach
(
i.
e.,
chronic,
short­/
intermediate­
term,
and
cancer).
It
should
be
noted,
however,
that
residential
risks
alone
were
of
concern
for
most
scenarios
which
would
preclude
the
calculation
of
DWLOCs.
However,
to
allow
for
a
more
informed
risk
management
decision,
a
few
residential
scenarios
were
selected
to
calculate
illustrative
aggregate
risk
estimates.
In
most
cases,
these
were
estimates
based
on
average
application
rates
and
not
label
maximum
rates.
Other
scenarios
were
selected
that
had
public
health
concerns
associated
with
them.
Bayer
has
also
recently
submitted
a
probabilistic
aggregate
assessment
which
should
be
considered
in
conjunction
with
this
assessment.
It
is
also
recommended
that
the
results
of
the
suburban
resident
biological
monitoring
study
be
considered
because
the
exposure
measurements
from
that
study
represent
aggregate
exposure
estimates
for
that
populaiton
even
though
it
is
clear
that
residential
uses
account
for
the
largest
portion
of
the
overall
exposure
(
i.
e.,
homeowner
products
were
used
in
every
case).

The
results
of
the
acute
aggregate
assessment
indicate
that
inclusion
of
water
in
the
analysis
provided
similar
results
to
the
dietary
assessment.
In
essence,
the
addition
of
water
had
no
impact
on
the
results.
The
analyses
show
that
the
highest
exposed
population
subgroup,
children
(
1­
2
years
old)
consumed
93%
of
the
aPAD.
The
acute
dietary
exposure
estimate
for
the
general
U.
S.
population
was
43%
of
the
aPAD.
In
the
short­
term
assessment,
the
Agency
selected
representative
scenarios
where
residential
risks
alone
were
not
of
concern
including
mosquito
control,
oyster
harvesting,
golfing,
garden
harvest,
and
several
handler
uses.
Regardless
of
the
drinking
water
source,
aggregate
risks
were
not
of
concern
for
the
selected
scenarios
keeping
in
mind
those
that
were
selected
represented
average
application
rates
or
public
health
scenarios
and
the
Agency
has
risk
concerns
for
residential
exposures
alone
for
many
scenarios
at
higher
application
rates.
Separate
intermediate­
term
aggregate
risk
and
14
DWLOC
calculations
were
not
completed
for
carbaryl
because
the
short­
term
aggregate
risk
estimates
essentially
presented
the
same
results
since
the
hazard
inputs
were
numerically
identical.
The
only
major
differences
would
be
related
to
the
postapplication
residential
exposures
where,
instead
of
a
single
day
exposure
estimate,
the
exposures
represented
a
30
day
average.
Aggregate
chronic
and
cancer
risks
were
not
of
concern
for
any
subpopulation
regardless
of
the
source
of
drinking
water.

Cumulative
Risks:

Carbaryl
is
a
member
of
the
carbamate
class
of
pesticides.
This
class
also
includes
aldicarb,
methomyl
and
oxamyl
among
others.
The
N­
methyl
carbamates,
as
a
group,
have
been
determined
to
share
a
common
mechanism
of
toxicity
(
July
2001
memo
from
Office
Director
Marcia
Mulkey).
However,
a
cumulative
risk
assessment
has
not
been
performed
as
part
of
this
review
because
the
Agency
is
currently
examining
approaches
for
completing
this
type
of
assessment.
EPA's
Office
of
Research
and
Development
is
currently
investigating
the
pharmacokinetics
and
pharmcodynamics
of
Nmethyl
carbamates
which
will
provide
a
more
solid
scientific
foundation
for
the
cumulative
assessment
of
these
pesticides
in
the
future.

The
issue
of
completing
a
cumulative
risk
assessment
for
organophosphate
and
carbamate
cholinesterase
inhibiting
compounds
has
also
been
raised.
The
Agency
does
not
believe
that
calculation
of
cumulative
risks
for
the
organophosphorus
(
OP)
pesticides
and
N­
methyl
carbamates
(
including
carbaryl)
is
appropriate.
Both
classes
of
compounds
inhibit
acetylcholinesterase
(
ChE),
but
there
are
differences
in
pharmacokinetics
and
pharmacodynamics
between
the
two
groups
that
raise
significant
uncertainty
regarding
the
appropriateness
of
dose
addition
and
that
will
have
a
significant
impact
on
cumulative
toxicity.
Thus,
these
two
classes
of
anticholinesterase
compounds
have
a
very
different
time
course
of
events
including:
time
to
peak
effect,
compound
half­
life
in
the
body,
duration
of
action,
and
recovery
time
after
exposure.

Companion
Probabilistic
Aggregate
Risk
Assessments
Bayer
has
submitted
a
probabilistic
aggregate
assessment
using
the
CARES
model
which
has
been
reviewed
by
the
FIFRA
Science
Advisory
Panel.
The
Agency
has
begun
evaluating
the
inputs
and
analysis
for
the
CARES
assessment.
Because
of
the
late
submission
date
related
to
the
release
of
this
assessment,
the
Agency
has
only
completed
a
preliminary
analysis
and
review
of
the
submission.
It
should
also
be
noted
that
to
date,
the
Agency
has
not
identified
any
issues
that
are
significant
enough
to
preclude
the
use
of
this
analysis
in
the
regulatory
decision
making
process.
The
Agency
will
develop
separate
document
that
describes
the
inputs
and
results
of
these
efforts
in
more
detail
at
a
later
date
which
will
also
be
considered
in
the
risk
management
decision
making
process.

Given
the
recent
submission
date,
and
the
short
time
for
the
preliminary
evaluation,
it
is
still
too
early
to
draw
any
final
conclusions
about
Bayer's
use
of
the
CARES
model
to
assess
human
health
risks
from
carbaryl
uses.
It
will
take
the
EPA
some
time
to
complete
and
in­
depth
analysis
and
come
to
any
conclusions
about
its
validity.
In
this
preliminary
analysis
the
focus
for
the
Agency
has
been
3
to
5
year
old
children
since
they
are
thought
to
be
a
highly
exposed
segment
of
the
population
and
the
results
can
be
compared
to
the
Agency's
deterministic
assessment
for
children
playing
on
turf
(
i.
e.,
based
on
Jazzercize)
because
that
model
is
intended
to
represent
children
of
that
age.
Also
the
results
of
the
suburban
resident
biological
monitoring
study
can
be
used
for
comparison.
In
the
analysis,
several
15
preliminary
conclusions
have
been
drawn
including
risks
for
the
general
population
at
the
99.9th
%
tile
do
not
appear
to
be
of
concern.
These
risks
are
driven
primarily
by
dietary
exposures.
These
results
should
be
considered
in
the
context
with
the
knowledge
that
residential
use
occurs
in
a
very
small
percentage
of
the
population
(
i.
e.,
~
0.4%)
in
a
manner
which
could
significantly
impact
exposures
(
i.
e.,
lawn
broadcast
applications).
It
should
also
be
pointed
out
that
the
exposure
estimates
for
the
general
population
closely
mirror
those
calculated
in
the
Agency's
dietary
risk
analyses
and
in
various
population­
based
biological
monitoring
studies
(
e.
g..,
NHANES).
The
Agency
recognizes
that
residential
uses
can
also
lead
to
significant
personal
exposures
so
it
completed
a
residential
lawn
broadcast
treatment
"
users
only"
assessment.
That
analysis
shows
risk
concerns
beginning
at
the
central
tendency
of
exposure
and
that
MOEs
at
the
upper
percentiles
are
in
the
5
to
10
range.
It
also
appears
that
for
the
"
user
only"
population
that
dietary
and
drinking
water
exposures
are
small
contributors.
It
should
be
pointed
out
that
this
result
is
very
consistent
with
the
results
of
the
biological
monitoring
study
and
that
the
deterministic
assessment
for
children
playing
on
lawns
(
i.
e.,
based
on
Jazzercize)
closely
approximates
the
upper
percentile
exposures
calculated
with
CARES.
To
reiterate,
the
conclusions
presented
here
are
considered
preliminary
and
the
results
and
interpretation
of
Bayer's
CARES
submission
may
be
altered
by
the
Agency
pending
further
review.

Occupational
Handlers:

There
is
significant
potential
for
exposure
to
carbaryl
users
in
a
variety
of
agricultural
and
commercial
settings.
Tasks
associated
with
occupational
carbaryl
use
include
mixing,
loading
and
applying
the
chemical
or
guiding
aerial
applications
(
flaggers).
All
these
activities
are
collectively
referred
to
as
handler
tasks.
A
total
of
28
scenarios
were
considered
representative
of
the
range
of
handler
activities,
crops
or
acres
treated
and
equipment
used.
The
risks
from
dermal
and
inhalation
exposures
were
calculated
and
then
added
together
to
obtain
overall
risk
estimates
at
varying
levels
of
personal
protection.
Risks
from
long­
term
(
chronic)
exposures
were
only
calculated
for
a
limited
number
of
scenarios
in
the
ornamental/
greenhouse
industry.
The
short­
and
intermediate­
term
risk
assessments
were
conducted,
as
described
above
(
i.
e.,
hazard
inputs
were
unchanged
including
target
MOE
=
100).
The
long­
term
risk
assessment
for
carbaryl
was
based
on
a
1
year
dog
feeding
study
where
effects
(
ChEI)
were
observed
at
3.1
mg/
kg/
day
(
LOAEL).
The
target
MOE
was
300
(
customary
100x
plus
3x
for
use
of
LOAEL).

Risks
were
calculated
assuming
one
of
eight
possible
levels
of
personal
protection
equipment,
ranging
from
a
baseline
of
typical
work
clothing
(
long­
sleeved
shirt
and
long
pants,
no
respiratory
protection
and
no
chemical­
resistant
gloves)
to
engineering
controls,
such
as
a
closed
cab
or
closed
loading
system.
Current
carbaryl
labels
typically
require
that
handlers
wear
long
pants,
long­
sleeved
shirts,
and
gloves
but
do
not
require
respirators.
For
most
scenarios,
the
noncancer
risks
for
this
personal
protection
ensemble
do
not
meet
Agency
risk
requirements
and
additional
levels
of
personal
protection
are
required
to
achieve
Agency
risk
targets.
In
fact,
in
many
cases
engineering
controls
such
as
closed
loading
systems
or
closed
cab
tractors
are
needed.
The
Agency
does
have
risk
concerns
over
the
use
of
carbaryl
in
some
agricultural
and
other
occupational
settings
regardless
of
the
level
of
personal
protection
used
(
i.
e.,
MOEs
at
any
level
of
personal
protection
are
<
targets).
As
would
be
expected,
these
scenarios
with
the
highest
associated
risk
also
have
high
daily
chemical
use
amounts
based
on
application
rates
or
high
acreages
treated
or
the
exposures
for
the
scenarios
in
question
are
relatively
high.
Generally,
the
areas
that
appear
to
be
problematic
include:
large
acreage
aerial
and
chemigation
applications
in
agriculture
or
for
wide
area
treatments
such
as
mosquito
control;
airblast
2
The
Agency
has
defined
a
range
of
acceptable
cancer
risks
based
on
a
policy
memorandum
dated
August
14,
1996,
by
Office
of
Pesticide
Programs
Director
Dan
Barolo.
This
memo
refers
to
a
predetermined
quantified
"
level
of
concern"
for
occupational
carcinogenic
risk.
Occupational
carcinogenic
risks
that
are
1
x
10­
6
or
lower
require
no
risk
management
action.
For
those
chemicals
subject
to
reregistration,
the
Agency
is
to
carefully
examine
uses
with
estimated
risks
in
the
10­
6
to
10­
4
range
to
seek
ways
of
cost­
effectively
reducing
risks.
If
carcinogenic
risks
are
in
this
range
for
occupational
handlers,
increased
levels
of
personal
protection
are
warranted
as
is
commonly
applied
with
noncancer
risk
estimates
(
e.
g.,
additional
PPE
or
engineering
controls).
Carcinogenic
risks
that
remain
above
1.0
x
10­
4
at
the
highest
level
of
mitigation
appropriate
for
that
scenario
remain
a
concern.

16
applications
at
higher
rates;
pet
grooming;
and
the
use
of
certain
handheld
equipment
for
applications
to
turf
or
gardens
(
e.
g.,
bellygrinder).
This
general
trend
was
essentially
the
same
for
exposures
of
any
duration.
Several
data
gaps
were
also
identified
in
many
different
use
areas
that
include:
dust
use
for
animal
grooming
and
in
agriculture;
various
specialized
hand
equipment
application
methods
(
e.
g.,
powered
backpack,
power
hand
fogger,
and
tree
injection);
and
nursery
operations
such
as
seedling
dips.

The
risk
of
cancer
for
occupational
handlers
was
calculated
for
two
populations,
private
growers
(
10
applications
per
year)
and
commercial
applicators
(
30
applications
per
year),
using
the
same
28
scenarios.
According
to
Agency
policy,
acceptable
cancer
risks
for
occupational
exposure
to
pesticides
can
vary
from
1x10­
4
to
1x10­
6,
depending
on
the
course
of
action
taken
by
the
Agency
as
outlined
in
the
subject
policy2.
Risks
for
corresponding
scenarios
based
on
cancer
concerns
were
generally
less
than
the
corresponding
noncancer
results
across
all
scenarios.
In
fact,
in
all
but
one
scenario,
cancer
risks
were
<
1x10­
4
at
current
carbaryl
label
requirements
of
single
layer
clothing,
gloves,
and
no
respirator
for
both
private
growers
and
commercial
applicators
(
i.
e.,
mixing/
loading
wettable
powders
for
wide
area
aerial
applications).
Higher
levels
of
personal
protection
reduce
this
risk
to
<
1x10­
4
in
both
populations.
If
a
1x10­
6
risk
level
is
specified
as
a
concern,
results
are
similar
in
that
risks
for
a
majority
of
scenarios
are
<
1x10­
6
at
current
label
requirements.
In
fact,
only
8
of
the
140
scenarios
considered
for
private
applicators
have
cancer
risks
>
1x10­
6
(
and
less
than
1x10­
4)
even
with
the
most
protective
ensembles
of
protective
clothing
or
engineering
controls.
For
commercial
applicators,
results
indicate
that
risks
for
about
half
of
the
scenarios
considered
are
<
1x10­
6
at
current
label
requirements
and
that
only
21
of
the
140
scenarios
considered
have
cancer
risks
>
1x10­
6
(
and
less
than
1x10­
4)
even
with
the
most
protective
ensembles
of
either
protective
clothing
or
engineering
controls.

Occupational
Postapplication
(
Reentry
Workers):

Workers
can
be
exposed
to
carbaryl
residues
when
entering
previously
treated
areas
to
perform
certain
activities,
such
as
harvesting.
Current
label
requirements
specify
12
hour
Restricted
Entry
Intervals
(
REIs)
while
Pre­
Harvest
Intervals
(
PHIs)
are
less
than
7
days
for
most
crops
with
some
as
long
as
28
days.
Non­
cancer
risks
from
short­
and
intermediate­
term
dermal
postapplication
exposure
were
calculated
for
18
representative
crop
groupings.
The
risks
from
long­
term
dermal
exposures
were
calculated
for
only
a
limited
number
of
scenarios
in
the
greenhouse
and
floriculture
industries.
For
each
scenario,
the
risk
on
the
day
of
application
was
calculated,
along
with
the
time
required
to
reach
the
target
MOE,
allowing
for
dissipation
of
the
carbaryl
residues.
For
all
but
the
lowest
exposure
scenarios
in
some
crops,
MOEs
do
not
meet
or
exceed
target
MOEs
until
several
days
after
application.
If
shortterm
risks
are
considered,
MOEs
meet
or
exceed
target
MOEs
generally
in
the
range
of
3
to
5
days
after
application
for
lower
to
medium
exposure
activities
and
from
8
to
12
days
after
application
in
most
17
higher
exposure
scenarios.
If
intermediate­
term
risks
are
considered,
MOEs
are
not
of
concern
based
on
a
30
day
average
exposures
except
for
higher
level
exposures
such
as
harvesting
in
some
crops.
Chronic
exposures
are
of
concern
for
the
cut
flower
industry
but
not
for
other
general
greenhouse
and
nursery
production
activities.

Cancer
risks
were
calculated
for
private
growers
and
professional
farmworkers
with
the
only
difference
being
the
annual
frequency
of
exposure
days.
Cancer
risks
for
private
growers
and
commercial
farmworkers
are
generally
in
the
10­
8
to
10­
6
range
on
the
day
of
application.
If
a
1x10­
4
cancer
risk
is
the
target,
the
current
REI
would
be
adequate
for
all
scenarios
considered
in
the
assessment.
If
a
1x10­
6
cancer
risk
is
used,
then
durations
longer
than
the
current
REI
should
be
considered
for
some
higher
exposure
scenarios.
It
should
be
noted
that
the
cancer
risk
calculations
are
less
restrictive
than
noncancer
risk
estimates
for
the
same
scenarios
in
all
cases.
Many
mechanized
or
partially
mechanized
processes
are
possibly
associated
with
the
use
of
carbaryl
that
may
limit
or
eliminate
exposures
(
e.
g.,
combines
for
grain
harvest).
Guidance
contained
in
the
Worker
Protection
Standard
(
WPS)
on
this
issue
should
be
considered
when
interpreting
the
results
of
this
assessment
as
the
WPS
provides
specifics
on
addressing
tasks
that
would
not
potentially
be
subject
to
a
Restricted
Entry
Interval
(
REI).
Additionally,
it
should
also
be
noted
that
the
preliminary
results
of
a
biological
monitoring
study
for
tree
fruit
thinners
and
harvesters
supports
the
exposure
estimates
used
by
the
Agency
in
this
assessment.

Human
and
Domestic
Animal
Incidents:

HED
evaluated
reports
of
human
carbaryl
poisonings
and
adverse
reactions
associated
with
its
use
from
the
following
sources:
OPP
Incident
Data
System
(
IDS);
Poison
Control
Centers'
Toxic
Exposure
Surveillance
System;
California
Department
of
Pesticide
Regulation;
the
National
Pesticide
Telecommunications
Network
(
NPTN);
open
literature;
and
an
unpublished
study
submitted
by
the
registrant.
The
data
from
IDS
indicated
that
a
majority
of
cases
from
carbaryl
exposure
involved
dermal
reactions.
A
number
of
other
cases
involved
asthmatics
and
people
who
experienced
hives
and
other
allergic
type
reactions.
It
is
noted
that
the
dermal
sensitization
study
in
the
guinea
pig
was
negative.
Reports
of
allergic­
type
reactions
in
humans
could
be
evidence
of
a
difference
in
species
sensitivity
or
could
be
attributable
to
inert
ingredients
in
the
marketed
formulations.
It
is
recommended
that
labels
for
products
should
advise
that
carbaryl
can
cause
sensitizing
effects
in
some
people.
According
to
California
data,
about
half
of
the
cases
involved
skin
and
eye
effects
in
handlers.
About
a
quarter
of
the
skin
reactions
were
due
to
workers
that
were
exposed
to
residues
on
crops.
Reports
from
the
literature
are
very
limited
but
tend
to
support
the
finding
that
carbaryl
has
irritant
properties.
The
Poison
Control
Center
cases
involving
non­
occupational
adults
and
older
children
showed
an
increased
risk
in
five
of
the
six
measures
used
for
comparing
carbaryl
incidents
to
all
other
pesticides.
The
carbaryl
cases
were
almost
twice
as
likely
to
require
serious
health
care
(
hospitalization
or
treatment
in
a
critical
care
unit)
and
were
two
and
a
half
times
more
likely
to
experience
major
medical
outcome
(
life­
threatening
effects
or
significant
residual
disability)
than
other
pesticides.
This
pattern
of
increased
risk
was
not
seen
among
occupational
reports
or
in
young
children.
This
may
mean
that
careless
handling
by
non­
professionals
is
a
particular
hazard.
Five
case
report
studies
suggested
that
carbaryl
may
be
a
cause
of
chronic
neurological
or
psychological
problems.
Some
of
these
effects
appear
to
be
consistent
with
those
reported
from
organophosphate
poisoning.
However,
unlike
organophosphates,
no
controlled
studies
have
been
undertaken.
If
such
effects
occur
as
a
result
of
overexposure
to
carbaryl,
they
appear
to
be
relatively
rare.
The
effects
reported
among
the
five
case
reports
18
are
too
inconsistent
to
draw
any
conclusions,
but
do
suggest
the
need
for
further
study.
The
epidemiologic
study
submitted
by
the
registrant
compared
mortality
rates
in
plant
workers
exposed
to
carbaryl
to
the
general
population.
HED
concluded
that
the
sample
of
workers
was
too
small
and
the
period
of
follow­
up
too
short
to
permit
definitive
conclusions.

The
incident
reports
on
domestic
animals
in
IDS
were
evaluated.
Based
on
limited
data,
there
is
some
evidence
that
young
kittens
may
be
susceptible
to
adverse
reactions
to
carbaryl.
It
is
recommended
that
all
labels
for
carbaryl
products
used
on
cats
contain
the
age
restriction
stated
in
PR
Notice
96­
6
(
should
not
be
used
in
kittens
less
than
12
weeks
of
age).

Issues
For
Consideration:

The
database
for
carbaryl
is
sufficient
for
conducting
a
risk
assessment
for
reregistration
purposes.
However,
the
results
of
the
risk
assessment
hinge
on
the
interpretation
of
elements
in
certain
key
pieces
of
data
that
include:
use
of
various
residue
data,
characterization
of
the
carbamate
market
basket
survey,
site
selection
in
the
water
monitoring
study,
revised
PRZM­
EXMS
estimates,
transfer
coefficient
updates
for
tree
fruit
workers,
updated
data
and
methods
for
calculating
exposure
to
pets,
use
information
from
the
Residential
Exposure
Joint
Venture,
Bayer's
evaluation
of
pharmacokinetics
in
humans,
and
use
of
results
from
the
suburban
resident
biological
monitoring
study.
In
the
dietary
assessment,
all
residue
data
translation
was
done
based
on
current
Agency
policy
and
the
use
of
the
best
data
available
for
each
situation.
In
conjunction,
the
Agency
used
the
most
current
dietary
intake
information
for
the
assessment
(
i.
e.,
CFSII
1994­
1998).
Also,
the
Agency
has
attempted
to
characterize
the
impact
of
rubbing
certain
commodities
during
sample
collection
in
the
market
basket
survey
because
carbaryl
residues
are
believed
to
be
surface
residues
as
it
is
a
contact
and
not
a
systemic
insecticide.
In
fact,
use
of
the
CMBS
data
had
very
little
impact
on
the
overall
results
of
the
assessment
so
this
issue
becomes
less
critical
for
risk
managers
to
consider.

The
Agency
does
not
believe
that
the
quantitative
use
of
Bayer's
recent
carbaryl
water
monitoring
study
is
appropriate
for
the
risk
assessment
purposes
because
selection
of
the
monitored
sites
was
not
adequately
justified
(
i.
e.,
they
were
deemed
to
be
vulnerable
by
Bayer
but
the
justification
provided
was
inadequate
and
sample
collection
was
too
infrequent).
As
such,
the
estimated
environmental
concentrations
(
EECs)
for
surface
water
used
in
the
assessment
were
from
revised
PRZM­
EXAMs
calculations
in
which
the
inputs
were
modified
to
reflect
the
most
recent
environmental
fate
parameters
and
water
treatment
factors
for
carbaryl.
Data
from
Bayer's
surface
water
monitoring
study
and
national
monitoring
by
NAWQA
were,
however,
used
to
characterize
the
modeled
results.

For
occupational
exposures
(
handlers
and
post­
application),
the
most
major
changes
were
modification
of
the
transfer
coefficients
for
tree
fruit
harvesters/
thinners
and
the
addition
of
scenarios
that
address
the
USDA/
APHIS
grasshopper
control
program.
Outside
of
these
issues,
the
overall
risk
picture
for
occupational
exposures
remains
unchanged.
It
is
clear
that
the
reduction
for
tree
fruit
harvesters
(
and
all
related
activities
except
thinning)
from
3000cm2/
hr
to
1500
cm2/
hr
is
appropriate
based
on
the
data.
The
transfer
coefficient
value
for
tree
fruit
thinners
remained
at
3000
cm2/
hr,
however,
which
is
supported
by
results
of
a
recent
biological
monitoring
study
of
tree
fruit
thinners
and
harvesters
completed
by
Bayer
using
carbaryl
presented
at
the
International
Society
of
Exposure
Analysis
meeting
in
2002.
Exposure
factors
used
to
address
grasshopper
control
scenarios
were
defined
based
on
direct
input
from
APHIS.
19
The
risk
picture
for
residential
exposure
scenarios
is
complex
in
that
assessments
for
homeowner/
users
and
the
general
population
have
been
completed
using
deterministic
methods
and
also
based
on
the
results
of
a
suburban
resident
biological
monitoring
study.
The
CARES
probabilistic
aggregate
exposure
assessment
should
also
be
considered
in
the
overall
risk
picture.
For
pet
uses,
data
from
a
study
which
quantified
transferable
residues
from
dogs
wearing
pet
collars
were
used.
This
study
is
of
marginal
quality
but
the
associated
risks
for
collars
are
above
the
Agency's
level
of
concern.
However,
the
Agency
would
like
a
higher
quality
confirmatory
study
for
this
scenario
because
MOEs
are
just
slightly
above
the
level
of
concern.
For
other
pet
products,
these
data
essentially
confirm
the
Agency's
concerns
over
their
use
(
e.
g.,
dusts
and
liquids).
In
the
other
residential
deterministic
assessments,
the
risk
picture
remains
essentially
unchanged
from
previous
assessments.
The
Agency
has
concerns
over
children's
exposure
on
treated
turf
and
for
various
homeowner
use
products,
especially
dusts.

The
results
of
the
suburban
resident
biological
monitoring
study
indicate
that
there
are
risk
concerns
particularly
for
younger
children
and
applicators
which
mirrors
the
results
of
the
deterministic
assessments.
However,
there
are
many
interpretative
issues
related
to
the
use
of
these
data
including
how
the
monitored
population
relates
to
the
overall
population
of
carbaryl
users
and
the
general
United
States
population
(
i.
e.,
these
are
key
factors
for
tolerance
review
under
FQPA
and
exposure
pathway
review
under
FIFRA).
There
are
also
issues
related
to
how
the
risks
were
calculated
because
of
the
excretion
profile
of
carbaryl
and
the
unrestricted
activities
of
those
monitored
in
the
study.
It
is
clear
that
carbaryl
users
who
treat
turf
in
a
manner
that
can
lead
to
significant
exposure
(
e.
g.,
broadcast)
represent
about
0.5
percent
of
the
United
States
population
and
that
when
these
turf
applications
are
combined
with
ornamental
or
garden
applications
that
an
even
smaller
percentage
of
the
population
is
represented.
However,
it
should
be
pointed
out
that
the
Agency
believes
the
predominant
source
of
exposure
is
from
the
treated
turf
and
it
is
expected
that
there
would
be
little
or
no
difference
in
the
results
of
this
study
if
turf
alone
was
treated
in
each
residence.
It
is
also
clear
that
for
applicators
and
young
children,
if
treatments
occur,
exposures
will
occur
at
levels
that
are
of
concern
to
the
Agency
for
the
higher
percentiles
of
exposure
based
on
this
study.
Bayer
and
the
Agency
essentially
agree
on
this
point.
There
are
differences
between
Bayer
and
the
Agency,
however,
based
on
central
tendency
exposure
statistics
in
that
Bayer's
calculations
do
not
indicate
a
risk
concern
while
the
Agency's
do.
The
major
difference
is
that
Bayer's
approach
does
not
account
for
mass
balance
as
defined
in
the
excretion
profile
for
carbaryl.
The
Agency
approach,
conversely,
indicates
risk
concerns
at
the
central
tendency
and
it
accounted
for
mass
balance.
Bayer
argues,
however,
that
how
the
population
monitored
in
the
biomonitoring
study
relates
to
the
general
population
is
key
for
framing
any
risk
management
decision.
It
is
Bayer's
position
that
central
tendency
exposures
from
the
study
represent
very
high
percentile
exposures
in
the
general
population.
The
Agency
does
not
disagree.
However,
it
should
be
pointed
out
that
the
approach
for
FIFRA
risk
analysis
(
not
tolerance
evaluation
under
FQPA)
has
always
been
to
consider
users
themselves
based
on
calculations
that
represent
the
upper
percentiles
of
exposure
for
users
to
ensure
that
they
are
adequately
protected.
As
such,
for
user
populations,
it
is
recommended
that
risk
management
decisions
be
based
on
higher
percentile
exposures.
If
this
is
the
case,
Bayer
concurs
with
the
Agency
that
there
are
risk
concerns
related
to
the
residential
use
of
carbaryl.
If
central
tendency
estimates
are
used,
it
should
be
pointed
out
that
the
Agency
does
not
concur
with
Bayer's
approach
for
calculating
dose
estimates
because
of
a
lack
of
accounting
for
mass
balance.
Conversely,
when
mass
balance
is
accounted
for
there
are
risk
concerns
even
for
central
tendency
exposure
estimates.
20
The
results
and
interpretation
of
the
probabilistic
assessment
for
carbaryl,
especially
when
considered
in
context
with
the
other
types
of
assessments
and
data,
are
very
consistent
with
the
various
assessments
that
have
been
completed.
For
example,
the
general
population
assessment
agrees
closely
with
the
Agency's
dietary
assessment
completed
using
DEEM/
FCID.
This
is
logical
because
the
percentage
of
residential
users
in
the
general
population
is
relatively
very
small
so
it
would
be
anticipated
that
residential
use
would
not
drive
an
assessment
for
the
general
population.
In
order
to
allow
for
a
more
informed
risk
management
decision,
the
Agency
also
considered
"
users
only"
in
an
assessment
and
again,
the
results
are
very
similar
to
what
would
be
expected
based
on
the
suburban
resident
biological
monitoring
study
and
the
Agency's
deterministic
approaches
for
calculating
residential
exposure.
There
are
remaining
key
issues
that
the
Agency
will
address
in
its
more
detailed
review
of
Bayer's
probabilistic
assessment.
These
include:
the
Agency
will
carefully
evaluate
each
input
parameter;
the
Agency
will
carefully
examine
the
methods
and
choices
related
to
execution
of
the
CARES
model
related
to
carbaryl;
and
the
Agency
will
better
define
how
the
results
of
a
true
probabilistic
aggregate
assessment
will
be
integrated
into
the
risk
assessment
and
risk
management
processes.

One
final
issue
to
consider
is
how
the
results
for
each
residential
risk
assessment
approach
relate
to
one
another
and
also
how
accurate
the
exposure
calculations
are
for
carbaryl.
To
do
this,
the
Agency
compared
the
deterministic
residential
exposure
estimates
to
those
calculated
in
the
biomonitoring
study
and
in
the
probabilistic
analysis.
Agency
deterministic
methods
are
intended
to
provide
upper
percentile
(
i.
e.,
protective)
estimates
of
exposure
which
is
exactly
what
appears
to
be
the
case
because
Agency
deterministic
predictions
overlap
very
closely
with
the
upper
percentiles
of
exposure
in
the
biomonitoring
study
and
probabilistic
analysis.
The
Agency
also
compared
the
biomonitoring
results
to
several
population­
based
monitoring
studies
(
e.
g.,
NHANES
and
NHEXAS)
and
found
that
the
distributions
are
very
similar
at
the
central
tendency
and
at
the
upper
percentiles
which
also
supports
the
accuracy
and
protective
nature
of
the
Agency's
deterministic
methods.
Results
also
appear
to
be
consistent
with
results
of
the
probabilistic
assessment.

Overall
Risk
Summary
This
risk
assessment
is
based
on
the
latest
exposure
data,
toxicology
information,
and
use
data.
The
overall
results
indicate
that
the
Agency
has
risk
concerns
for
several
marketplaces
where
carbaryl
is
used.
Dietary
risks
are
generally
not
of
concern
regardless
of
what
data
are
considered
(
i.
e.,
FDA\
PDP
or
CMBS).
Residential
handler
and
postapplication
risks
are
of
concern
across
many
areas.
However,
the
manner
of
interpretation
of
the
suburban
resident
biological
monitoring
study
and
the
results
of
the
companion
probabilistic
assessment
are
critical
in
evaluating
residential
uses.
To
allow
for
a
more
informed
risk
management
decision,
the
Agency
considered
aggregate
exposures
for
selected
residential
scenarios
which
were
not
already
of
concern
when
calculated
using
deterministic
methods
(
i.
e.,
some
at
typical
rates
and
selected
public
healthuses).
Even
though
surface
water
concentrations
are
high,
aggregate
risks
for
the
selected
scenarios
were
not
of
concern
in
these
deterministic
assessments.
The
Agency
also
has
presented
risk
estimates
for
residential
users
based
on
the
suburban
biological
monitoring
study
which
indicates
a
risk
concern
for
applicators
and
small
children
even
at
the
central
tendency
of
exposure
for
those
populations.
The
companion
probabilistic
assessment
also
needs
to
be
considered.
When
exposures
in
the
general
population
were
evaluated,
risks
at
the
99.9th
%
tile
are
not
of
concern
but
it
should
be
pointed
out
that
there
is
a
very
small
percentage
of
the
population
that
would
potentially
be
affected
through
residential
exposure.
If
residential
users
only
are
considered
in
a
21
probabilistic
manner,
the
results
very
closely
mirror
that
observed
in
the
biological
monitoring
study
where
risks
are
of
concern
(
depending
on
interpretation
of
the
data
and
the
probabilistic
assessment
results)
for
small
children
at
the
central
tendency
of
exposure.
The
upper
bounds
of
the
distribution
for
these
children
also
closely
mimics
the
Agency's
deterministic
methods
which
is
consistent
with
the
characterization
of
that
approach.
Occupational
handler
risks
can
be
mitigated
through
the
use
of
additional
protective
measures
over
and
above
the
current
label
such
as
engineering
controls
(
e.
g.,
closed
cabs
or
loading
systems).
Current
label
REIs
are
12
hours.
For
almost
every
crop/
activity
combination
considered
except
some
low
exposure
activities,
the
current
REI
appears
to
be
inadequate.
22
O
O
N
H
CH
3
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION
The
product
chemistry
chapter
was
prepared
by
Felicia
Fort
of
the
Health
Effects
Division
(
November
14,
2000
­
DP
Barcode
240989).
All
information
below
is
excerpted
from
that
chapter
unless
specifically
noted.
Section
2.1:
Chemical
Structure
and
Identification
presents
the
nomenclature
and
structures
associated
with
carbaryl
and
its
metabolites.
Section
2.2:
Physical
Properties
of
Carbaryl
presents
information
about
the
properties
of
carbaryl.

2.1
Chemical
Structure
and
Identification
Chemical
Name:
1­
naphthyl
methylcarbamate
Empirical
Formula:
C12H11NO2
Molecular
Weight:
201.2
CAS
Registry
No.:
63­
25­
2
Chemical
ID
No.:
056801
Structures
of
carbaryl
and
major
metabolites
are
shown
below
in
Figure
1.

Figure
1.
Structures
of
Carbaryl
and
Major
Metabolites
Name
Structure
Carbaryl
1­
Naphthyl
N­
methylcarbamate
5,6­
dihydro­
5,6­
dihydroxy
carbaryl
Figure
1.
Structures
of
Carbaryl
and
Major
Metabolites
Name
Structure
3
From
the
EPA
Technology
Transfer
Network,
Office
of
Air
Quality
Planning
and
Standards,
Air
Toxics
Website
(
www.
epa.
gov/
ttn/
atw)

23
OH
5­
methoxy­
6­
hydroxy
carbaryl
1­
Naphthol
2.2
Physical
Properties
of
Carbaryl
Physical
state:
white
to
light
tan
solid
Melting
point:
1420C
Solubility:
water
(
40
ppm
at
25
C),
dimethyl
formamide
(#
45
g/
100
mL);
acetone,
cyclohexanone,
and
isophorone
(#
25
g/
100
mL);
methylethyl
ketone
(#
20
g/
100
mL);
dichloromethane
(#
15
g/
100
mL);
ethanol
and
ethyl
acetate
(#
10
g/
100
mL);
mixed
aromatic
solvents
and
xylene
(#
3
g/
100
mL);
and
kerosene
(#
1
g/
100
mL).
Vapor
pressure:
0.000041
mm
Hg
at
260C3
Specific
gravity:
1.23
at
200C
Octanol/
water
partition
coefficient
(
Kow):
217
24
3.0
HAZARD
CHARACTERIZATION
The
hazard
component
of
the
risk
assessment
is
presented
in
this
section.
Section
3.1:
Hazard
Profile
presents
a
discussion
of
the
available
toxicity
data
for
carbaryl.
Section
3.2:
FQPA
Considerations
discusses
the
susceptibility
of
sensitive
populations
such
as
children
and
the
uncertainties
associated
with
that
analysis.
Section
3.3:
Dose
Response
Assessment
describes
which
data
were
selected
for
risk
assessment
purposes.
Section
3.4:
Endocrine
Disruption
describes
issues
related
to
EDSTAC
and
the
screening
process
for
possible
chemicals
of
concern.

3.1
Hazard
Profile
The
updated
Toxicology
Chapter
of
the
RED
was
prepared
by
Dr.
Virginia
Dobozy
(
D282980).
The
toxicology
data
base
is
of
good
quality
and
is
essentially
complete.
A
90­
day
inhalation
study
with
cholinesterase
measurements
is
required.
The
database
provides
sufficient
information
for
selecting
toxicity
endpoints
for
risk
assessment
and
therefore,
supports
a
reregistration
eligibility
decision
for
the
currently
registered
uses.

Carbaryl
is
a
carbamate
insecticide.
Its
primary
mode
of
toxic
action
is
through
cholinesterase
inhibition
(
ChEI)
after
single
or
multiple
exposures.
In
most
of
the
toxicology
studies
in
which
ChEI
was
measured,
it
was
the
endpoint
used
to
set
the
Lowest
Observed
Adverse
Effect
Level
(
LOAEL).

The
acute
toxicity
studies
showed
that
carbaryl
was
relatively
toxic
with
acute
oral
dosing
(
Tox.
Category
II);
but
the
acute
dermal
and
inhalation
toxicities
were
low
(
Tox.
Categories
III
and
IV,
respectively).
Carbaryl
was
not
a
dermal
or
eye
irritant
and
was
not
a
dermal
sensitizer
in
animal
studies
(
Table
1).
However,
human
incidents
of
dermal
irritation
and
dermal
manifestations
of
an
allergic
response
have
been
reported
(
see
section
7.4
below
for
more
information).

Table
1:
Acute
Toxicity
of
Carbaryl
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Category
81­
1
Acute
Oral
­
rat
(
99%
a.
i.)
00148500
LD50
for
males
=
302.6
mg/
kg;
for
females
=
311.5
mg/
kg;
combined
=
307.0
mg/
kg
II
81­
2
Acute
Dermal
­
rabbit
(
99%
a.
i.)
00148501
LD50
>
2000
mg/
kg
III
81­
3
Acute
Inhalation
­
rat
(
99%
a.
i.)
00148502
LC50
>
3.4
mg/
L
IV
81­
4
Primary
Eye
Irritation
­
rabbit
(
99%
a.
i.)
00148503
not
a
primary
eye
irritant
IV
81­
5
Primary
Skin
Irritation
­
rabbit
(
99%
a.
i.)
00148504
not
a
primary
skin
irritant
IV
Table
1:
Acute
Toxicity
of
Carbaryl
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Category
25
81­
6
Dermal
Sensitization
­
guinea
pig
(
99%
a.
i.)
00148505
negative
NA
81­
7
Acute
Delayed
Neurotoxicity
(
Hen)
*
negative
at
2000
mg/
kg
(
approximate
LD50)
NA
81­
8
Acute
Neurotoxicity
­
rat
43845201­
43845204
systemic
LOAEL
=
10
mg/
kg
for
males
and
females
based
on
significant
inhibition
of
RBC,
plasma,
whole
blood
and
brain
cholinesterase;
NOAEL
<
10
mg/
kg
a.
i.
=
active
ingredient
*
Carpenter,
C.
P.,
Weil,
C.
S.,
Palm,
P.
E.,
Woodside,
N.
W.,
Nair,
J.
H.
and
Smyth,
H.
F.
Mammalian
Toxicity
of
1­
napthyl­
Nmethyl
carbamate
(
Sevin
Insecticide).
J.
Agric.
Food
Chem.
9(
1):
30­
39,
1961.

The
neurotoxicity
data
showed
that
carbaryl
was
not
a
delayed
neurotoxicant
in
the
hen.
In
the
acute
neurotoxicity
study
in
the
rat
after
a
single
dose
of
10
mg/
kg
carbaryl,
ChEI
was
observed
in
plasma,
whole
blood,
red
blood
cells
(
RBC)
and
brain.
At
the
next
higher
dose
(
50
mg/
kg),
clinical
signs
typical
of
carbamate
toxicity
were
observed.
In
the
subchronic
neurotoxicity
study
after
90
days
of
administration,
clinical
signs
of
toxicity
were
seen
at
the
same
dose
(
10
mg/
kg/
day)
as
plasma,
whole
blood,
RBC
and
brain
ChEI.
There
was
no
evidence
of
structural
neuropathology
in
these
studies.

No
subchronic
studies
in
the
rat
or
dog
are
available,
except
for
the
subchronic
neurotoxicity
study
in
rats
and
4­
week
dermal
toxicity
studies
in
rats
(
one
with
technical
chemical
and
two
with
formulations).
One
of
the
dermal
toxicity
studies
was
useful
for
risk
assessment.
In
this
study,
the
systemic
NOAEL
was
20
mg/
kg/
day
based
on
decreased
RBC
ChEI
in
males
and
females
and
brain
ChEI
in
males
at
50
mg/
kg/
day.
The
chronic
toxicity
data
showed
that,
in
dogs,
decreases
in
plasma,
RBC
and
brain
ChEI
were
observed
at
10
mg/
kg/
day;
clinical
signs
of
toxicity
were
also
observed
in
both
sexes
at
31
mg/
kg/
day.
Brain
and
plasma
ChEI
were
decreased
in
female
dogs
at
3.1
mg/
kg/
day.
In
the
mouse,
clinical
signs
of
toxicity
were
not
typical
of
ChEI,
but
there
was
ChEI
(
plasma,
RBC
and
brain)
at
146
mg/
kg/
day.
In
the
chronic
toxicity
study
in
rats,
carbaryl
at
the
highest
dose
(
350
mg/
kg/
day
in
males
and
485
mg/
kg/
day
in
females)
caused
a
variety
of
toxic
effects
in
the
liver,
kidneys
and
urinary
bladder.
It
also
induced
an
increase
in
the
incidence
of
thyroid
follicular
cell
hypertrophy
and
degeneration
of
sciatic
nerves
and
skeletal
muscle.
RBC
ChEI
was
decreased
in
males
at
60
mg/
kg/
day
and
in
females
at
79
mg/
kg/
day.
The
lowest
LOAEL
in
the
chronic
studies
was
in
the
chronic
dog
study,
i.
e.,
3.1
mg/
kg/
day,
which
was
the
lowest
dose
in
females.
In
a
follow­
up
5­
week
study
in
dogs
to
clarify
the
NOAEL
for
ChEI,
plasma
ChEI
was
decreased
in
males
at
3.83
mg/
kg/
day;
no
effects
were
observed
at
1.43
mg/
kg/
day.
26
In
a
prenatal
developmental
toxicity
study
in
the
rat,
maternal
toxicity
was
observed
at
the
same
dose
(
10
mg/
kg/
day)
as
developmental
toxicity;
the
NOAEL
was
4
mg/
kg/
day.
Developmental
effects
included
decreased
fetal
body
weight
and
increased
incomplete
ossification
of
multiple
bones.
In
a
prenatal
developmental
toxicity
study
in
the
rabbit,
the
maternal
and
developmental
LOAELs
were
50
mg/
kg/
day
and
150
mg/
kg/
day,
respectively.
The
respective
NOAELs
were
5
mg/
kg/
day
and
50
mg/
kg/
day.
The
only
evidence
of
developmental
toxicity
was
a
decrease
in
fetal
body
weight.
These
studies
showed
no
evidence
of
a
qualitative
or
quantitative
increased
susceptibility.
In
the
reproduction
study,
there
was
evidence
of
a
quantitative
offspring
susceptibility.
The
LOAEL
for
parental
systemic
toxicity
was
1500
ppm
(
92.43­
124.33
mg/
kg/
day
for
males
and
110.78­
135.54
mg/
kg/
day
for
females)
based
on
decreased
body
weight,
weight
gain,
and
feed
consumption.
The
NOAEL
was
300
ppm
(
23.49­
31.34
mg/
kg/
day
for
males
and
26.91­
36.32
mg/
kg/
day
for
females).
The
LOAEL
for
offspring
toxicity
was
300
ppm
(
23.49­
31.34
mg/
kg/
day
for
males
and
26.91­
36.32
mg/
kg/
day
for
females)
based
on
increased
numbers
of
F2
pups
with
no
milk
in
the
stomach
and
decreased
pup
survival.
The
NOAEL
was
75
ppm
(
4.67­
5.79
mg/
kg/
day
for
males
and
5.56­
6.41
mg/
kg/
day
for
females).
In
the
developmental
neurotoxicity
study,
there
was
evidence
of
qualitative
susceptibility.
Clinical
signs
of
toxicity
and
plasma
and
brain
ChEI
were
seen
in
maternal
animals
at
the
same
dose
(
10
mg/
kg/
day)
as
changes
in
brain
morphometric
measurements
(
decreases
in
cerebellar
measurements
in
females
on
Day
11
post­
partum)
were
observed
in
offspring;
however,
brain
measurements
were
not
conducted
at
the
next
lower
dose.

The
Health
Effects
Division's
(
HED)
Cancer
Assessment
Review
Committee
(
CARC)(
11/
7/
01)
classified
carbaryl
as
Likely
to
be
carcinogenic
in
humans
based
on
an
increased
incidence
of
hemangiosarcomas
in
male
mice
at
all
doses
tested
(
100,
1000
and
8000
ppm).
The
Q1*,
based
on
the
CD­
1
mouse
dietary
study
with
¾
Interspecies
Scaling
Factor,
is
8.75
x
10­
4
(
mg/
kg/
day)­
1
in
human
equivalents.
In
addition
to
the
required
carcinogenicity
studies
in
mice
and
rats,
the
registrant
submitted
a
special
study
in
genetically
modified
mice.
Carbaryl
was
administered
to
heterozygous
p53­
deficient
(
knockout)
male
mice
in
the
diet
at
concentrations
of
up
to
4000
ppm
(
716.6
mg/
kg/
day)
for
six
months.
There
was
no
evidence
of
neoplastic
or
preneoplastic
changes
in
the
vascular
tissues
of
any
organ.
A
model
validation
study
demonstrated
that
vascular
tumors
occur
in
heterozygous
p53
deficient
mice
within
six
months
of
administration
of
a
known
genotoxic
carcinogen
(
urethane).

A
recent
review
of
the
data
from
the
submitted
studies
and
the
published
literature
show
that
carbaryl
is
clastogenic
in
vitro.
The
wide
variety
of
induced
aberrations
(
both
simple
and
complex)
was
consistent
between
the
submitted
micronucleus
study
and
the
open
literature.
However,
there
are
inconsistencies
relative
to
the
requirement
for
S9
activation.
Nevertheless,
the
two
in
vivo
studies
for
micronuclei
induction
or
chromosome
aberrations
were
negative.
Similarly,
the
6­
month
p53
knockout
transgenic
mouse
bioassay
was
negative.
Carbaryl
was
also
negative
for
DNA
binding
in
the
livers
of
mice
treated
with
8000
ppm
for
2
weeks.
Metabolism
studies
identified
epoxide
intermediates
of
carbaryl
which
were
found
to
be
conjugated
to
glucuronide,
rapidly
metabolized
and
excreted
as
any
endogenous
epoxide
would
be.
Overall,
these
findings
indicate
that
carbaryl
produces
epoxides
and
its
DNA
reactivity
is
manifested
as
chromosomal
aberrations
in
cultured
mammalian
cells.
Other
in
vitro
27
studies
indicate
carbaryl's
effects
on
karyokinesis
and
cytokinesis,
as
well
as
stress
genes
associated
with
oxidative
damage.
Based
on
these
considerations,
the
CARC
concluded
that
there
is
a
concern
for
mutagenicity,
which
is
somewhat
lessened
because
of
the
lack
of
an
effect
in
in
vivo
mutagenicity
studies.

The
metabolism
data
in
the
rat
indicated
that
radiolabeled
carbaryl
was
readily
absorbed
with
oral
dosing,
distributed
to
various
organs,
metabolized
and
formed
conjugated
metabolites
with
compounds
such
glucuronic
acid.
A
total
of
20
components
was
found,
and
2
major
metabolites
were
identified,
naphthyl
sulfate
and
naphthyl
glucuronide.
Much
of
the
radioactivity
was
eliminated
within
24
hours
after
dosing
(
86%
in
urine
and
11%
in
feces).
Seven
days
post
dosing,
negligible
amounts
of
the
administered
dose
were
found
in
tissues.
Several
special
metabolism
studies
were
conducted
to
explore
a
mechanism
for
the
increase
in
tumor
incidence
in
mice.
The
results
appear
to
show
that
high
doses
of
carbaryl
treatment
(
1154
mg/
kg)
led
to
a
"
phenobarbital"
type
of
induction
of
liver
xenobioticmetabolizing
enzymes
and
interaction
of
carbaryl
with
chromatin
protein
in
mice.
A
dermal
absorption
study
indicated
that
12.7%
of
a
carbaryl
formulation
(
43.9%
a.
i.)
was
absorbed.
[
Note:
Bayer
provided
a
synopsis
of
research
related
to
the
pharmacokinetics
of
carbaryl
in
humans
which
is
described
in
more
detail
in
Section
4.4.4:
Risks
Based
On
Carbaryl
Suburban
Resident
Biomonitoring
Study.
This
synopsis
indicates
40
percent
of
carbaryl
is
eliminated
in
the
urine,
excretion
of
a
single
dose
takes
96
hours
for
complete
elimination,
and
50
percent
of
each
single
dose
is
eliminated
in
the
first
24
hours
post
administration.]

The
toxicology
profile
for
carbaryl
is
presented
in
Appendix
1.

3.2
FQPA
Considerations
The
HIARC
(
February
19,
2002
meeting)
concluded
that
there
is
a
concern
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
carbaryl.

3.2.1
Determination
of
Susceptibility
There
was
no
evidence
of
quantitative
or
qualitative
susceptibility
following
in
utero
exposures
in
developmental
studies
in
the
rat
and
rabbit.

In
the
reproduction
study,
there
was
evidence
of
quantitative
susceptibility
of
offsprings.
The
LOAEL
for
parental
systemic
toxicity
was
based
on
decreased
body
weight,
weight
gain,
and
feed
consumption;
the
NOAEL
was
27
mg/
kg/
day
in
males
and
30
mg/
kg/
day
in
females.
In
the
offspring
the
LOAEL
was
based
on
increased
numbers
of
F2
pups
with
no
milk
in
the
stomach
and
decreased
pup
survival;
the
NOAEL
was
5
mg/
kg/
day
in
males
and
6
mg/
kg/
day
in
females.
No
adverse
effects
were
observed
in
the
reproductive
parameters.

In
the
developmental
neurotoxicity
study,
there
was
evidence
of
qualitative
susceptibility.
For
maternal
toxicity,
the
LOAEL
was
based
on
decreased
body
weight
gain,
alterations
in
Functional
28
Observational
Battery
measurements
and
inhibition
of
plasma,
whole
blood
and
brain
cholinesterase
activity;
the
NOAEL
was
1
mg/
kg/
day.
For
developmental
neurotoxicity,
the
LOAEL
was
based
on
the
morphometric
changes
seen
in
the
brain
of
the
offsprings;
the
NOAEL
was
1
mg/
kg/
day.

3.2.2
Degree
of
Concern
Analysis
and
Residual
Uncertainties
The
HIARC
concluded
that
there
are
no
residual
concerns
related
to
the
2­
generation
reproduction
study
because
the
dose­
response
for
the
offspring
effects
is
well­
characterized
and
these
effects
occurred
at
a
dose
level
which
is
above
that
used
for
establishing
the
Chronic
Reference
Dose
(
cRfD)
for
chronic
dietary
risk
assessment.

The
HIARC
established
the
Chronic
RfD
using
the
LOAEL
of
3.1
mg/
kg/
day
in
the
chronic
toxicity
study
in
dogs.
Since
a
NOAEL
was
not
established
in
this
study,
an
additional
uncertainty
factor
of
3X
was
applied
to
the
LOAEL
(
i.
e,
UFL).
The
HIARC
determined
that
3X
is
adequate
to
account
for
the
lack
of
a
NOAEL
in
this
case
because:
1)
the
study
was
well­
conducted
and
there
are
sufficient
data
from
subchronic
and
other
chronic
studies
in
other
species
that
support
cholinesterase
inhibition
as
the
critical
effect
for
Carbaryl;
2)
the
data
indicate
that
the
dog
is
more
sensitive
to
the
cholinergic
effects
of
Carbaryl
and
using
this
species
to
establish
the
RfD
provides
additional
protection
for
the
effects
seen
in
the
rat
(
including
the
reproduction
and
developmental
neurotoxicity
studies);
3)
the
magnitude
of
plasma
cholinesterase
inhibition
(
12­
23%
decrease)
seen
in
this
study
was
comparable
to
the
magnitude
of
inhibition
(
22%)
seen
in
the
5­
week
study
in
dogs
­
indicating
no
cumulative
effect
following
long­
term
exposure;
4)
the
cholinesterase
inhibition
seen
in
females
at
the
LOAEL
in
this
study
was
not
accompanied
by
clinical
signs
(
response
was
not
judged
to
be
severe);
and
5)
no
inhibition
was
seen
for
any
cholinesterase
compartment
in
males
at
this
dose
(
response
was
seen
in
only
one
sex).

The
HIARC
concluded
that
the
extrapolated
NOAEL
of
1
mg/
kg/
day
used
to
establish
the
Chronic
RfD
for
Carbaryl
is
below
the
NOAEL
for
offspring
toxicity
(
5
mg/
kg/
day)
in
the
2­
generation
reproduction
study
and
is
protective
of
chronic
dietary
exposures
to
infants
and
children.

The
HIARC
concluded
that
there
was
a
low
level
of
concern
for
the
developmental
effects
seen
in
the
developmental
neurotoxicity
study
and
no
residual
uncertainties
with
respect
to
this
study
based
on
the
following
evidence:

°
Any
concern
for
the
lack
of
brain
morphometric
measurements
in
the
offspring
at
the
mid­
dose
(
1
mg/
kg/
day)
was
negated
since
even
at
the
high
dose
of
10
mg/
kg/
day,
the
morphometric
changes
were
minimal
and
therefore,
it
is
unlikely
that
adverse
effects
would
be
seen
at
the
middose
level
(
1
mg/
kg/
day
­
10%
of
the
LOAEL).

°
Any
concern
for
the
lack
of
comparative
data
in
adults
and
offspring
for
cholinesterase
inhibition
was
negated
since
no
FOB
alterations
were
seen
in
pups.
Other
studies
in
the
data
base
show
that
when
cholinesterase
inhibition
was
seen
in
adult
animals,
it
usually
was
accompanied
by
FOB
alterations.
Additionally,
the
results
of
the
National
Institute
for
Environmental
Health
Sciences
study
(
discussed
above)
indicate
that
there
is
no
difference
in
cholinesterase
inhibition
in
pups
and
adults.
The
dose­
related
decrease
in
cholinesterase
activity
in
the
brain
and
blood
of
dams
at
29
gestation
day
19
was
very
similar
to
the
fetal
brain
cholinesterase
levels
taken
at
the
same
time.

The
HIARC
established
the
Acute
RfD
for
Carbaryl
using
the
NOAEL
of
1
mg/
kg/
day
in
the
developmental
neurotoxicity
study
in
rats
which
is
protective
of
single
dose
exposures
to
infants
and
children.

3.3
Dose
Response
Assessment
The
HIARC
evaluated
the
toxicology
data
base
of
carbaryl,
reassessed
the
Reference
Dose
(
RfD)
established
in
1994
and
selected
the
toxicological
endpoints
for
acute
dietary,
as
well
as
occupational
and
residential
exposure
risk
assessments
at
a
meeting
on
July
7,
1998.
Re­
evaluations
of
the
FQPA
Safety
Factor
recommendation
were
done
on
April
28
and
November
15,
1999,
after
the
submission
of
prenatal
developmental
toxicity
studies
in
the
rat
and
rabbit,
respectively.
A
re­
evaluation
of
the
endpoints
for
risk
assessment
was
conducted
on
March
1,
2001,
February
19,
2002
and
April
25,
2002.
Table
2
contains
a
summary
of
the
hazard
doses
and
endpoints
selected
for
use
in
the
various
human
health
risk
assessments.
Endpoints
were
selected
for
a
broad
spectrum
of
risk
assessments,
including
acute
and
chronic
dietary,
short­,
intermediate­
and
long­
term
dermal
and
inhalation
exposures
and
short­
and
intermediate­
term
incidental
exposure.
For
the
chronic
dietary
and
the
long­
term
dermal
and
inhalation
exposure
endpoints,
a
LOAEL
was
selected,
which
necessitated
an
additional
3x
uncertainty
factor.

A
common
toxicological
endpoint
exists
for
the
dermal,
inhalation,
and
incidental
oral
routes.
Therefore,
the
Margins
of
Exposure
(
MOEs)
can
be
combined
for
aggregate
occupational
and
residential
risk
assessments.

Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Carbaryl
for
Use
in
Human
Risk
Assessment
Exposure
Scenario
Dose
(
mg/
kg/
day)
&
Total
UF
Hazard
Based
Special
FQPA
Safety
Factor
Endpoint
for
Risk
Assessment
Dietary,
Nondietary
Ingestion
&
Biomonitoring­
based
Risk
Assessments
Acute
Dietary
general
population
including
infants
and
children
NOAEL
=
1
UF
=
100
1
Developmental
Neurotoxicity
­
rat
LOAEL
=
10
mg/
kg/
day
based
on
an
increased
incidence
of
FOB
changes
on
the
first
day
of
dosing
in
maternal
animals
Acute
RfD
and
aPAD
=
0.01
mg/
kg/
day
Chronic
Dietary
all
populations
LOAEL=
3.1
UF
=
300
1
Chronic
toxicity
­
dog
LOAEL
=
3.1
mg/
kg/
day
based
on
plasma
and
brain
cholinesterase
inhibition
in
females.

Chronic
RfD
and
cPAD
=
0.01
mg/
kg/
day
[
Note:
A
NOAEL
could
not
be
defined
in
this
study.
Therefore,
an
additional
factor
of
3
has
been
applied
to
account
for
the
data
deficiency.]
Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Carbaryl
for
Use
in
Human
Risk
Assessment
Exposure
Scenario
Dose
(
mg/
kg/
day)
&
Total
UF
Hazard
Based
Special
FQPA
Safety
Factor
Endpoint
for
Risk
Assessment
30
Short­
term
Incidental
Oral
&
Biological
Monitoring
(
1
­
30
Days)
[
Residential
Only]
NOAEL=
1
Res.
UF
=
100
1
Developmental
Neurotoxicity
­
rat
LOAEL
=
10
mg/
kg/
day
based
on
an
increased
incidence
of
FOB
changes
and
decreases
in
RBC,
whole
blood,
plasma
and
brain
cholinesterase
Intermediate­
Term
Incidental
Oral
(
1
­
several
months)
[
Residential
Only]
NOAEL=
1
Res.
UF
=
100
1
Subchronic
Neurotoxicity
­
rat
LOAEL
=
10
mg/
kg/
day
based
on
increased
incidence
of
FOB
changes;
decrease
in
RBC,
whole
blood,
plasma
and
brain
cholinesterase.

Non­
Dietary
Dermal
&
Inhalation
Risk
Assessments
Short­
Term
Dermal
(
1
­
30
days)
NOAEL=
20
Res.
UF
=
100
Occ.
UF
=
100
1
4­
week
dermal
toxicity
with
technical
­
rat
systemic
LOAEL
=
50
mg/
kg/
day
based
on
statistically
significant
decreases
in
RBC
cholinesterase
in
males
and
females
and
brain
cholinesterase
in
males.

Intermediate­
term
Dermal
(
30
days
­
several
months)
NOAEL=
20
Res.
UF
=
100
Occ.
UF
=
100
1
4­
week
dermal
toxicity
with
technical
­
rat
systemic
LOAEL
=
50
mg/
kg/
day
based
on
statistically
significant
decreases
in
RBC
cholinesterase
in
males
and
females
and
brain
cholinesterase
in
males.

Long­
Term
Dermal
(
Several
months
to
a
lifetime)
LOAEL=
3.1
Res.
UF
=
300
Occ.
UF
=
300
1
Chronic
toxicity
­
dog
LOAEL
=
3.1
mg/
kg/
day
based
on
plasma
and
brain
cholinesterase
inhibition
in
females.

[
Note:
A
NOAEL
could
not
be
defined
in
this
study.
Therefore,
an
additional
factor
of
3
has
been
applied
to
account
for
the
data
deficiency.
Also,
this
study
is
not
route­
specific
as
it
was
conducted
via
oral
administration.
Route­
to­
route
extrapolation
is
required
using
an
adsorption
factor
of
12.7
percent
which
is
based
on
a
rat
dermal
absorption
study.]

Short­
Term
Inhalation
(
1
­
30
days)
NOAEL=
1
Res.
UF
=
100
Occ.
UF
=
100
1
Developmental
Neurotoxicity
­
rat
LOAEL
=
10
mg/
kg/
day
based
on
an
increased
incidence
of
FOB
changes
and
statistically
significant
decreases
in
RBC,
whole
blood,
plasma
and
brain
cholinesterase
[
Note:
This
study
is
not
route­
specific
as
it
was
conducted
via
oral
administration.
Route­
to­
route
extrapolation
is
required
using
an
adsorption
factor
of
100
percent.]

Intermediate­
Term
Inhalation
(
30
days
­
several
months)
NOAEL=
1
Res.
UF
=
100
Occ.
UF
=
100
1
Subchronic
Neurotoxicity
­
rat
LOAEL
=
10
mg/
kg/
day
based
on
increased
incidence
of
FOB
changes;
decrease
in
RBC,
whole
blood,
plasma
and
brain
cholinesterase.

[
Note:
This
study
is
not
route­
specific
as
it
was
conducted
via
oral
administration.
Route­
to­
route
extrapolation
is
required
using
an
adsorption
factor
of
100
percent.]
Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Carbaryl
for
Use
in
Human
Risk
Assessment
Exposure
Scenario
Dose
(
mg/
kg/
day)
&
Total
UF
Hazard
Based
Special
FQPA
Safety
Factor
Endpoint
for
Risk
Assessment
31
Long­
Term
Inhalation
(
Several
months
to
a
lifetime)

[
Occupational
only]
LOAEL=
3.1
Occ.
UF
=
300
1
Chronic
toxicity
­
dog
LOAEL
=
3.1
mg/
kg/
day
based
on
plasma
and
brain
cholinesterase
inhibition
in
females.

[
Note:
A
NOAEL
could
not
be
defined
in
this
study.
Therefore,
an
additional
factor
of
3
has
been
applied
to
account
for
the
data
deficiency.
Also,
this
study
is
not
route­
specific
as
it
was
conducted
via
oral
administration.
Route­
to­
route
extrapolation
is
required
using
an
adsorption
factor
of
100
percent.]

Cancer
Classification:
C
Q1*
=
8.75
x
10­
4
(
mg/
kg/
day)­
1
3.4
Endocrine
Disruption
EPA
is
required
under
the
Federal
Food
Drug
and
Cosmetic
Act,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
were
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
carbaryl
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

4.0
NON­
OCCUPATIONAL
RISK
ASSESSMENT
AND
CHARACTERIZATION
This
section
of
the
risk
assessment
addresses
exposures
to
individuals
in
the
general
population
that
are
not
exposed
as
part
of
their
employment.
These
exposures
can
occur
through
the
diet
and/
or
they
can
occur
because
people
have
contact
with
carbaryl
residues
while
using
consumer
products
containing
carbaryl
or
by
being
in
areas
that
have
been
previously
treated.
Section
4.1:
Summary
of
Registered
Uses
below
summarizes
available
products
and
also
describes
the
uses
of
those
products.
Products
intended
for
commercial
sales
(
e.
g.,
in
agriculture)
and
consumer
products
are
included
as
each
type
of
product
can
contribute
to
non­
occupational
exposures
through
the
diet,
via
residential
use,
or
through
commercial
use
in
areas
frequented
by
the
general
population
such
as
golf
courses.
Section
4.2:
Dietary
Risk
Assessment
describes
the
residue
and
consumption
data
used
in
the
dietary
risk
assessment,
the
risks
associated
with
various
populations
of
interest
through
the
diet,
and
characterization
of
those
32
risks.
Section
4.3:
Water
Risk
Assessment
describes
how
water
concentrations
were
determined,
calculation
of
risks,
and
characterization
of
those
risks.
Section
4.4:
Residential
Risk
Assessment
describes
how
risks
were
calculated
for
people
who
use
consumer
products
containing
carbaryl
and
for
those
who
are
exposed
as
a
result
of
being
in
areas
that
have
been
previously
treated.
Results
based
on
the
Agency's
standard
deterministic
approaches
and
the
suburban
resident
biological
monitoring
study
are
included
in
this
section.

4.1
Summary
of
Registered
Uses
All
products
(
e.
g.,
manufacturing
and
various
end­
use
formulations)
and
the
associated
use
patterns
for
carbaryl
are
described
below.
A
brief
overview
of
the
types
of
equipment
and
application
rates
is
also
provided.
The
information
in
this
section
summarizes
all
use
patterns
of
carbaryl
as
both
commercial
products
and
products
intended
for
sale
to
homeowners
can
contribute
to
exposures
in
the
general
population.
The
need
to
have
a
thorough
understanding
of
the
use
patterns
for
consumer
products
is
self
explanatory.
Understanding
the
use
of
commercial
products
is
key
for
the
development
of
the
dietary
and
drinking
water
assessments.
It
is
also
critical
for
evaluating
some
residential
postapplication
exposures
in
public
places
(
e.
g.,
for
golfers).

Carbaryl
(
1­
naphthyl
N­
methyl­
carbamate)
is
a
broad­
spectrum
carbamate
insecticide
marketed
in
a
variety
of
end­
use
products
for
both
occupational
and
homeowner
use.
End­
use
product
names
include
Adios,
Bugmaster,
Carbamec,
Carbamine,
Crunch,
Denapon,
Dicarbam,
Hexavin,
Karbaspray,
Nac,
Rayvon,
Septene,
Sevin,
Tercyl,
Tornado,
Thinsec,
and
Tricarnam.
Use
sites
include
but
are
not
limited
to
the
following:
fruit
and
nut
trees;
vegetable
crops;
field
and
forage
crops;
grapes;
forestry;
lawns
and
other
turf
such
as
golf
courses;
ornamental
trees,
shrubbery,
annuals,
and
perennials;
wide
area
treatment
targets
such
as
residential
mosquito
adulticide
uses
and
oyster
beds;
and
companion
animals
(
e.
g.,
dogs
and
cats).
Table
3
summarizes
all
(
homeowner
and
occupational
products)
currently
available
technical
and
manufacturing
products
along
with
their
corresponding
EPA
registration
numbers.

Table
3:
Technical
and
Manufacturing
Carbaryl
Products
Formulation
EPA
Reg.
No.
(%
active
ingredient)

Technical
34704­
707
(
99%);
45735­
24
(
99%);
264­
324
(
99%),­
325
(
97.5%);
19713­
75
(
99%)

Manufacturing
Product
264­
328
(
80%);
264­
325
(
97.5%)
769­
971
(
80%);
5481­
190
(
46%)
19713­
369
(
50
%);
432­
982
(
97.5%);
73049­
238
(
1%)

Based
on
a
review
(
2/
27/
01)
of
the
Office
of
Pesticide
Programs
 
Reference
Files
System
(
REFS),
there
are
over
300
active
product
labels
(
i.
e.,
includes
both
homeowner
and
occupational
products).
Carbaryl
formulations
include
dusts,
emulsifiable
concentrates,
soluble
concentrates,
water
dispersable
granulars,
flowable
concentrates,
wettable
powders,
granulars,
baits,
pet
dips
and
pet
shampoos,
aerosol
sprays,
ready­
to­
use
pump
sprayers,
and
pet
collars
(
i.
e.,
treated
articles).
Table
4
33
summarizes
the
approximate
number
of
Section
3­
registered
products
in
each
formulation
category
and
the
range
of
percent
active
ingredient.
A
complete
listing
of
all
the
registration
numbers
under
each
category
can
be
found
in
the
Occupational/
Residential
Exposure
Assessment
chapter
(
D287251).
This
chapter
also
includes
in
the
Appendices,
the
Qualitative
Usage
Analysis
For
Carbaryl
and
the
RED
Use
Profile
Report
prepared
by
the
Agency's
Biological
and
Economic
Analysis
Division
which
were
recently
updated
(
i.
e.,
2002).
The
major
changes
from
the
previous
QUA
are
related
to
the
percent
crop
treated
values
are
reflected
in
this
assessment.
In
most
cases
they
generally
went
down.
Many
of
the
products
described
can
be
used
in
a
variety
of
settings
ranging
from
agriculture
and
commercial
facilities
to
residential
areas.

Table
4:
Carbaryl
End­
Use
Product
Formulations
Formulation
Type
Number
of
Products
Range
of
Percent
Active
Ingredient
Emulsifiable
Concentrates
&
Flowable
Concentrates
57
0.3
­
80
Wettable
Powders
&
Soluble
Granules
36
0.5
­
95
Dusts
130
0.3
­
80
Granular
45
1.43
­
15
Bait
55
1.3
­
13
Dips,
Shampoos
2
0.5
­
60
Pet
collars
(
treated
articles)
2
8.5
­
16
Ready
to
Use
Pump
Sprayers
&
Aerosol
Cans
6
0.12
­
1
Equipment
used
to
apply
carbaryl
in
residential
settings
includes
dust
shaker
cans,
garden
hoseend
sprayers,
trigger
sprayers,
low
pressure
handwands,
belly
grinders,
push­
type
spreaders,
aerosol
cans,
and
pet
collars.
In
an
occupational
setting,
carbaryl
can
be
applied
by
airblast,
aerial
application,
chemigation,
groundboom,
power
duster,
low
and
high
pressure
handwand,
backpack,
compressed
air
sprayer,
fogger,
hand­
held
duster,
hose­
end
sprayer,
duster
cans,
and
aerosol
cans.
Depending
on
the
crop,
the
maximum
number
of
carbaryl
applications
per
season
can
range
from
1
to
8.
A
variety
of
application
rates
are
available
on
the
carbaryl
labels,
ranging
from
1
lb
ai/
acre
for
curcurbits
to
16
lb
ai/
acre
for
a
foliar
treatment
of
citrus
in
California.
Some
products
are
marketed
in
a
single
marketplace
while
others
are
sold
for
use
in
multiple
settings.
Based
on
sales
information
provided
by
Bayer
CropScience
at
the
SMART
meeting
with
EPA
on
September
24,
1998,
it
appears
that
approximately
34
34
percent
of
carbaryl
use
is
by
homeowners
in
residential
settings,
59
percent
is
used
in
agriculture,
and
the
remaining
7
percent
is
used
in
the
nursery,
landscape
and
golf
course
industries.
It
should
be
noted
also
that
Bayer's
Sevin
User
Survey
and
results
from
the
Residential
Exposure
Joint
Venture
were
used
to
develop
the
residential
aspects
of
this
assessment.

The
application
parameters
for
major
crop
groups
or
application
targets
were
defined
by
the
physical
nature
of
the
use
site,
the
physical
nature
of
the
formulation,
the
equipment
needed
for
application
and
the
application
rate.
The
timing
of
use
and
related
pest
complexes
were
also
considered
in
the
development
and
characterization
of
the
risk
estimates.
[
Note:
OPP/
BEAD
is
also
developing
a
substitutes
analysis
which
will
be
used
to
characterize
how
changes
in
market
share
might
affect
the
results
of
this
assessment
­
this
will
be
considered
during
the
risk
management
phase
of
the
Agency's
process.]
Selected
crop
groupings
and
application
targets
along
with
corresponding
typical
(
if
available)
and
maximum
application
rates
that
are
used
in
the
risk
assessment
are
presented
in
Table
5
below.

Table5:
Application
Rates
Considered
in
Risk
Assessment
Crop
or
Target
Occupational
Products
Residential
Products
lb
ai/
1000
ft2
(
units
may
vary)
lb
ai/
A/
acre
(
units
may
vary)
max.
apps/
season
lb
ai/
season
Average
Rates
Alfalfa,
clover,
trefoil
1.5
1/
cutting
1.5/
cutting
1.1
­
Asparagus
2
4
­
postharvest
3
­
broadcast
2
­
postharvest
6
­
broadcast
10
­
postharvest
0.9
0.023
­
0.094
Beans
(
fresh
&
dried),
cowpeas,
peas
1.5
4
6
0.9
0.012­
0.047
Beets,
carrot,
horseradish,
radish,
parsnip
2
­
foliar
2.2
­
soil
broadcast
6
­
foliar
4
­
soil
6
0.8
0.012­
0.047
Blueberries
2
­
foliar
0.5
lb/
1000
ft2
­
soil
5
10
1.7
0.012­
0.047
Cole
Crops
(
broccoli,
brussel
sprouts,
cabbage,
cauliflower,
chinese
cabbage,
collards,
kale,
kohlrabi,
mustard
greens)
2
­
foliar
2.2
­
soil
broadcast
4
6
0.8
0.012­
0.047
Caneberries
2
­
foliar
2.2
­
soil
broadcast
5
4
10
Not
specified
1.7
0.012­
0.047
Celery,
Dandelion
2
­
foliar
2.2
­
soil
broadcast
4
6
1.0
0.012­
0.047
Citrus
16
(
foliar
in
CA
only)
10
(
foliar
in
FL
only)
7.5
­
foliar
1
lb/
100
gal.
1
Not
specified
8
Not
specified
20
Not
specified
20
Not
specified
2.7
to
3.4
(
lemons
&
oranges)
0.023­
0.176
Corn
(
field
and
pop)
2
4
8
1.0
0.012­
0.047
Corn
(
sweet)
2
­
foliar
2.2
­
soil
broadcast
8
4
16
Not
specified
1.3
0.012­
0.047
Cranberry
2
5
10
2.0
0.012­
0.047
Cucurbits
(
cucumber,
melon,
pumpkin,
squash)
1
6
6
1.1
0.012­
0.047
Fruiting
Vegetable
(
tomato,
eggplant,
pepper)
2
7
8
1.0
0.012­
0.047
Table5:
Application
Rates
Considered
in
Risk
Assessment
Crop
or
Target
Occupational
Products
Residential
Products
lb
ai/
1000
ft2
(
units
may
vary)
lb
ai/
A/
acre
(
units
may
vary)
max.
apps/
season
lb
ai/
season
Average
Rates
35
Grapes
2
5
10
1.4
0.012­
0.047
Grasses
Grown
For
Seed
1.5
2
3
0.8
(
based
on
hay)
­

Leafy
Vegetable
(
head
and
leaf
lettuce,
endive,
mustard
green)
2
­
foliar
2.2
­
soil
broadcast
5
4
6
Not
specified
1.1
0.012­
0.047
Nuts
(
almond,
chestnut,
pecan,
pistachio,
walnut,
etc.),
foliar
or
dormant/
delayed
5
4
15
2.5
(
pecans)
0.047­
0.12
Nuts
(
almond,
chestnut,
pecan,
walnut),
foliar
in
CA
1
lb
ai/
100
gal
Not
specified
Not
specified
Not
specified
0.047­
0.12
Ornamental
2.2
or
2%
solution
­
­
1.5
0.023
Oyster
beds
(
SLN
only)
10
Not
specified
Not
specified
­
­
Peanut
2
5
8
0.8
0.012­
0.047
Pome
fruit
3
8
15
1.2
(
based
on
apples)
0.012­
0.07
Potatoes
&
Tubers
(
turnips)
2
6
6
0.8
­
Rangeland/
pastures
1
1
1
0.9
­
Rice
1.5
2
4
1.1
­
Right
of
Way
1.5
3
0.4
­
Sorghum
2
4
6
1.1
­
Stone
fruit
(
apricot,
cherry,
nectarine,
peach,
plum/
prune),
foliar
or
dormant/
delayed
3
4
­
CA
only
3
foliar
&
1
dormant/
delayed
14
1.1
0.047­
0.12
Stone
fruit
(
apricot,
cherry,
nectarine,
peach,
plum/
prune),
foliar
1
lb
ai/
100
gal
Not
specified
Not
specified
Not
specified
0.047­
0.12
Strawberries
2
5
10
1.4
0.012­
0.047
Sugar
beets
1.5
to
2
2
to
4
4
1.3
0.012­
0.047
Sweet
Potatoes
2
foliar
8
lb/
100
gal
drip
8
foliar
Not
specified
8
foliar
1.2
1.6
foliar
Not
specified
0.012­
0.047
Sunflower
1.5
2
3
0.7
0.012­
0.047
Tobacco
2
4
8
1.1
­
Tree
farm
1
­
2
0.7
­
Turf/
golf
8­
liquids
9­
granulars
­
0.8/
1000sf
2
to
4
0.047
to
0.25
(
lawns)
[
maximum
levels
for
different
products]
Wheat,
flax
1.5
2
3
0.8
­
Ants
2%
sol
­
­
­
2%
sol
Mosquito
Control
2
­
­
­
­

Outdoor
Banding
2%
sol
­
­
­
2%
sol
Table5:
Application
Rates
Considered
in
Risk
Assessment
Crop
or
Target
Occupational
Products
Residential
Products
lb
ai/
1000
ft2
(
units
may
vary)
lb
ai/
A/
acre
(
units
may
vary)
max.
apps/
season
lb
ai/
season
Average
Rates
4
At
the
present
time,
information
from
the
industry­
sponsored
Carbamate
Market
Basket
Survey
has
been
approved
for
use
in
dietary
risk
assessments
with
appropriate
characterization
of
uncertainties
associated
with
the
conduct
of
the
study.
The
primary
concern
was
rubbing
sampled
commodities
during
the
rinsing
process
except
for
broccoli
and
tomato
because
this
created
a
potential
for
residue
loss
from
the
mechanical
action
associated
with
rubbing.
A
separate
assessment
was
also
completed
using
other
sources
of
high
quality
residue
data
(
e.
g.,
PDP)
for
comparative
purposes
to
more
completely
inform
the
risk
management
process.

36
Domestic
Animals
(
e.
g.,
cats/
dogs)
Dust
0.2
lb
ai/
dog
Sha.
0.01
lb
ai/
dog
­
­
­
Dust
0.2
lb
ai/
dog
Sha.
0.01
lb
ai/
dog
Domestic
Animals
(
e.
g.,
cats/
dogs)
1.3
oz/
dog
collar
­
­
­
1.3
oz/
dog
collar
Note:
In
many
cases
an
application
rate
per
area
(
e.
g.,
1000
ft2)
is
provided
but
a
1
to
2
%
ai
w/
v
solution
can
be
used
to
make
similar
applications
where
volume
outputs
are
difficult
to
regulate
(
i.
e.,
handheld
equipment
where
area
treated
is
difficult
to
define).

4.2
Dietary
Risk
Assessment
The
Product
and
Residue
Chemistry
Chapters
(
D283328;
May
30,
2002)
and
the
Dietary
Exposure
Analysis
(
D288479;
March
11,
2003)
were
prepared
by
Felecia
Fort.
Potential
exposure
to
residues
of
carbaryl
in
the
diet
occurs
through
food
and
water.
Carbaryl
is
used
late
in
the
season
at
maximum
seasonal
rates
of
6­
12
lb
ai/
acre.
[
Note:
There
is
also
a
section
3
registration
that
allows
use
on
citrus
up
to
16
lb
ai/
acre
only
in
the
state
of
California.]
Post­
harvest
intervals
(
PHIs)
range
from
1­
29
days
but
most
are
one
week
or
less.
The
qualitative
nature
of
carbaryl
residues
in
plants
and
animals
is
adequately
understood.
The
carbaryl
residue
to
be
regulated
in
plants
is
carbaryl
per
se.
The
residues
of
concern
in
meat
and
milk
are
the
free
and
conjugated
forms
of
carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl,
and
5­
methoxy­
6­
hydroxy
carbaryl.
Adequate
Pesticide
Data
Program
(
PDP)
and
Food
and
Drug
Administration
(
FDA)
monitoring
residue
data
are
available
for
the
vast
majority
(>
80%)
of
commodities.
Detectable
residues
were
found
in
31
of
42
crops.
In
field
trials,
residues
were
less
than
the
Limit
of
Quantitation
(
LOQ)
in
5
crops
but
were
quantifiable
in
all
other
raw
agricultural
commodities
(
RACs).

The
dietary
exposure
assessment
is
a
Tier
3/
4
assessment,
which
is
the
most
highly
refined
assessment
that
can
be
conducted
at
this
time.
HED
has
provided
anticipated
residues
(
ARs)
for
carbaryl
based
on
USDA
PDP
and
FDA
monitoring
data,
along
with
field
trial
data,
for
many
commodities.
In
addition,
separate
acute
assessments
were
conducted
incorporating
the
results
of
the
Carbamate
Market
Basket
Survey
(
CMBS)
4.
37
Section
4.2.1:
Residue
Profile
provides
information
on
the
residue
data
used
to
complete
the
dietary
risk
assessments.
Section
4.2.2:
Acute
Dietary
Risk
Assessment
presents
the
acute
assessment
with
and
without
the
CMBS
data.
Section
4.2.3:
Chronic
Dietary
Risk
Assessment
presents
the
results
for
this
duration
of
exposure.
Section
4.2.4:
Cancer
Dietary
Risk
Assessment
presents
cancer
risks.
Section
4.2.5
Characterization/
Uncertainties
of
the
Risk
Estimates
provides
information
that
should
be
considered
along
with
the
numerical
results
of
this
assessment.

4.2.1
Residue
Profile
Tolerances
for
residues
of
carbaryl
are
currently
expressed
in
terms
of
carbaryl
(
1­
naphthyl
Nmethylcarbamate
including
its
hydrolysis
product
1­
naphthol,
calculated
as
carbaryl,
for
most
raw
crop
commodities
(
RACs)
[
40
CFR
§
180.169(
a)].
The
established
tolerances
for
residues
in/
on
pineapples,
pome
fruits,
avocados,
and
fresh
dill
are
expressed
in
terms
of
carbaryl
per
se
[
40
CFR
§
180.169(
d)
and
(
e)].
Tolerances
for
residues
in
livestock
commodities
are
expressed
as
carbaryl,
including
its
metabolites
1­
naphthol
(
naphthyl
sulfate),
5,6­
dihydrodihydroxy
carbaryl,
and
5,6­
dihydrodihydroxy
naphthol,
calculated
as
carbaryl
[
40
CFR
§
180.169(
b)
and
(
c)].
A
tolerance
for
residues
in
pineapple
bran
is
expressed
in
terms
of
carbaryl
per
se
[
40
CFR
§
186.550].
The
HED
Metabolism
Committee
concluded
that
the
carbaryl
residue
to
be
regulated
in
plants
is
carbaryl
per
se
(
DP
Barcode
D221979,
S.
Hummel,
2/
8/
96).
The
Committee
also
concluded
that
carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl,
5­
methoxy­
6­
hydroxy
carbaryl
and
all
residues
which
can
be
hydrolyzed
to
carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl
and
5­
methoxy­
6­
hydroxy
carbaryl
under
acidic
conditions
should
be
included
in
the
tolerance
expression
and
risk
assessment
for
all
endpoints
of
dietary
concern
only
for
livestock
commodities
(
C.
Olinger,
D255855,
6/
21/
99).
An
interim
tolerance
of
0.5
ppm
has
been
established
for
carbaryl
and
its
1­
naphthol
metabolite
in
eggs
[
40
CFR
§
180.319].
Tolerances
of
2
ppm
and
10
ppm
have
been
established
for
residues
of
carbaryl
in
pineapples
and
bananas,
respectively.
The
registrant
intends
to
support
the
tolerances
for
residues
of
carbaryl
in/
on
these
commodities
as
import
tolerances.

Currently,
the
Codex
MRLs
and
U.
S.
tolerances
are
not
compatible
because
the
U.
S.
tolerance
expression
includes
metabolites.
Once
the
U.
S.
tolerance
definition
is
amended,
it
will
be
compatible
with
the
definition
for
Codex
MRLs.
The
Metabolism
Committee
has
also
recommended
that
the
tolerance
expression
for
livestock
commodities
include
the
free
and
conjugated
forms
of
carbaryl;
5,6­
dihydro­
5,6­
dihydroxy
carbaryl;
and
5­
methoxy­
6­
hydroxy
carbaryl.
The
Codex
MRLs
and
U.
S.
tolerances
cannot
be
made
compatible
for
livestock
commodities
with
respect
to
the
tolerance
definition.

The
reregistration
requirements
for
plant
and
livestock
metabolism
are
fulfilled.
Acceptable
metabolism
studies
depicting
the
qualitative
nature
of
residues
in
lettuce,
radish,
soybeans,
ruminants
and
poultry
have
been
submitted
and
evaluated.
For
the
purpose
of
reregistration,
adequate
magnitude
of
the
residue
data
are
available
on
the
following
crops:
alfalfa,
almond,
asparagus,
beans
(
dried
and
succulent),
blueberry,
broccoli,
cabbage,
celery,
cherry,
citrus
fruits,
clover,
corn
(
sweet
and
field),
cucurbits
(
cantaloupes,
cucumbers
and
squash),
cranberry,
flax,
grape,
head
and
leaf
lettuce,
mustard
greens,
okra,
peanut,
peas
(
dried
and
succulent),
pecan,
pepper,
pistachio,
pome
fruits,
potato,
prickly
pear
cactus,
raspberry,
rice,
sorghum,
soybean,
spinach,
stone
fruits,
strawberry,
sunflower,
sweet
potato,
tobacco,
tomato,
walnut.
Geographical
representation
is
adequate
and
a
sufficient
number
of
trials
reflecting
representative
formulation
classes
were
conducted.
Carbaryl
residues
were
<
LOQ
in/
on
38
sweet
potato,
sugar
beets,
corn
grain,
flax
seed,
and
peanuts.
Quantifiable
residues
were
detected
in
all
other
RACs.
For
a
given
crop,
residue
levels
were
quite
variable
overall,
probably
owing
to
climactic
variations,
but
were
generally
consistent
within
any
specific
field
trial
location.
There
are
data
gaps
which
are
listed
in
Section
8.0:
Data
Needs/
Label
Requirements.

Adequate
PDP
monitoring
data
are
available
for
the
following
commodities:
potatoes,
carrots,
sweet
potato,
celery,
spinach,
lettuce
(
head),
broccoli,
succulent
peas
(
processed)
,
succulent
beans,
soybean,
tomatoes,
cantaloupe,
winter
squash,
orange,
orange
juice,
apple,
apple
juice,
pear,
peach,
wheat,
sweet
corn,
strawberry,
banana,
grape,
grape
juice,
pineapple,
rice,
cherry,
cucumber,
and
milk.
FDA
monitoring
data
were
used
for
the
commodities,
lettuce
(
leaf),
cabbage,
watermelon,
raspberry,
blueberry,
asparagus,
and
cranberry.
Monitoring
data
were
translated
to
similar
crops
when
possible,
generally
according
to
the
HED
SOP
99.3
"
Translation
of
Monitoring
Data".
Monitoring
data
from
the
years
1994
through
2001
(
PDP)
and
the
years
1992
through
1998
(
FDA)
were
considered.
Field
trial
data
were
used
for
the
commodities,
almonds,
pecans,
walnuts,
field
corn
grain,
flax
seed,
okra,
olive,
peanuts,
pistachio,
sugar
beets,
and
sunflower.
For
oysters
and
dill,
tolerances
of
2
ppm
and
0.2
ppm,
respectively
was
used
in
the
assessment.

HED
conducts
dietary
risk
assessments
using
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
The
1994­
96,
98
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
Foods
"
as
consumed"
(
e.
g.,
apple
pie)
are
linked
to
EPAdefined
food
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
N/
S;
baked;
or
wheat
flour
­
cooked;
fresh
or
N/
S,
baked)
using
publicly
available
recipe
translation
files
developed
jointly
by
USDA/
ARS
and
EPA.
For
acute
dietary
risk
assessments,
the
entire
distribution
of
consumption
events
for
individuals
is
multiplied
by
a
randomly
selected
distribution
of
residues
(
probabilistic
analysis,
referred
to
as
"
Monte
Carlo"
)
to
obtain
a
distribution
of
exposures
in
mg/
kg/
day.
For
chronic
dietary
risk
assessments,
the
2­
day
average
for
each
subpopulation
is
combined
with
average
residues
in
commodities
to
determine
average
exposures
(
mg/
kg/
day).

Anticipated
residue
estimates
were
prepared
using
USDA
Pesticide
Data
Program
(
PDP)
data,
if
available.
Alternatively,
FDA
surveillance
monitoring
data
from
the
years
1992­
98
were
used
if
sufficient
samples
were
available.
Data
from
crop
field
trials
were
used
if
there
were
insufficient
PDP
or
FDA
monitoring
data.
In
addition,
a
separate
acute
assessment
was
conducted
incorporating
the
results
of
the
Carbamate
Market
Basket
Survey
(
CMBS)
as
described
above
(
i.
e.,
rubbing
fruit
may
reduce
residues,
use
of
other
high
quality
data
leads
to
a
more
informed
risk
management
decision).
HED
used
CMBS
data
for
citrus
fruit
and
banana
in
all
acute
assessments
since
these
commodities
are
peeled
before
consumption.

The
Biological
and
Economic
Analysis
Division
(
BEAD)
provided
information
(
F.
Hernandez,
12/
17/
02)
on
the
percent
crop
treated
(%
CT).
For
the
chronic
analysis,
the
weighted
average
%
CT
was
incorporated;
for
the
acute
analysis,
the
estimated
maximum
%
CT
was
used
when
appropriate.
In
acute
analyses
(
except
blended
commodities)
the
adjustment
for
%
CT
is
incorporated
in
the
residue
distribution
files
(
RDFs)
via
addition
of
zero
residue
values
corresponding
to
the
%
of
crop
not
treated.
39
For
blended/
not
furthered
processed
commodities
where
monitoring
data
are
available,
the
entire
distribution
of
monitoring
data
with
no
further
adjustment
for
%
CT
were
used.
For
blended/
processed
commodities
where
monitoring
data
are
available
and
for
all
blended
commodities
where
field
trial
data
were
used,
%
CT
is
incorporated
into
a
point
estimate.
For
the
chronic
analyses,
the
%
CT
is
listed
as
Adjustment
Factor
2
in
the
DEEM
analysis.
One
half
the
weighted
average
of
the
limits
of
detection
was
used
in
the
dietary
assessment
for
all
treated
non­
detectable
residues.
Detectable
residues
from
composite
monitoring
data
for
non­
blended
food
forms
were
used
to
generate
residue
values
in
single
units
using
the
methods
described
in
the
H.
Allender
paper
dated
5/
26/
99
"
Statistical
methods
for
Use
of
Composite
Data
in
Acute
Dietary
Risk
Assessment."
The
"
decomposited"
residues
were
then
included
in
residue
distribution
files
(
RDF)
for
the
probabilistic
analysis.
BEAD­
supplied
percent
crop
treated
data
were
incorporated
into
the
anticipated
residue
or
residue
distribution
file
when
appropriate.
[
Note:
Single
serving
apple
and
peach
PDP
data
were
used
for
non­
blended
peach
and
apple
food
forms,
respectively,
instead
of
data
that
had
been
previously
decomposited
(
Allender
method).]

A
separate
dietary
assessment
was
conducted
utilizing
the
CMBS
results.
The
CMBS
Task
Force
conducted
a
year
long,
national
survey
of
carbamate
residues
on
selected
food
commodities
purchased
at
grocery
stores.
Residue
data
from
a
market
basket
survey
are
considered
close
approximations
to
residues
potentially
found
at
most
`
dinner
plates.'
These
data
are
generally
considered
the
most
appropriate
survey
type
for
use
in
pesticide
risk
and
exposure
assessment.
The
CMBS
collected
up
to
400
single­
serve
samples
of
8
different
crops
(
apple,
banana,
broccoli,
grape,
lettuce,
orange,
peach
and
tomato).
These
data
were
used
in
the
acute
dietary
analysis
directly
via
RDFs
incorporating
%
CT
for
all
food
forms
which
are
considered
to
be
partially
or
not
blended.
For
blended
commodities,
the
entire
distribution
of
data
with
no
further
adjustment
for
%
CT
was
used.
If
CMBS
data
were
not
available,
then
PDP
or
FDA
monitoring
or
field
trial
data
were
used.
CMBS
data
were
translated
to
similar
commodities
when
feasible;
however,
if
PDP
monitoring
data
were
available
for
the
processed
commodity,
then
CMBS
data
were
not
translated
(
i.
e.,
PDP
orange
juice
data
were
used
instead
of
CMBS
data
for
oranges).
The
dietary
risk
assessments
were
completed
with
and
without
the
results
of
the
CMBS
(
except
for
banana
and
citrus
CMBS
data)
for
comparative
purposes,
again
as
described
above
(
i.
e.,
rubbing
fruit
may
reduce
residues,
use
of
other
high
quality
data
leads
to
a
more
informed
risk
management
decision).

Most
of
the
carbaryl
processing
factors
were
obtained
from
processing
studies
submitted
by
the
registrant.
The
rice
processing
factors
were
from
a
review
by
Thurston
Morton
(
D216242,
9/
17/
98).

4.2.2
Acute
Dietary
Risk
Assessment
The
following
equations
were
used
to
calculate
dietary
exposure
and
non­
cancer
risk
for
carbaryl.

Dietary
exposure
(
mg/
kg/
day)
=
consumption
x
residue
Dietary
risk
(%
PAD)
=
dietary
exposure
(
mg/
kg/
day)
x
100
population
adjusted
dose
(
mg/
kg/
day)
40
The
population
adjusted
dose
(
PAD)
is
the
adjusted
RfD
reflecting
the
retention
or
removal
of
the
FQPA
safety
factor.
For
carbaryl,
the
FQPA
safety
factor
has
been
reduced
to
1x.
The
resulting
acute
PAD
(
aPAD)
and
chronic
PAD
(
cPAD)
are
both
0.01
mg/
kg/
day.
The
doses
and
endpoints
selected
by
the
HIARC
for
these
risk
assessments
are
discussed
in
more
detail
in
Section
3.3:
Dose
Response
Assessment
above.

For
this
Tier
3/
4
Assessment,
estimated
acute
dietary
exposure
at
the
99.9th
percentile
of
exposure
are
below
HED's
level
of
concern
without
incorporating
the
CMBS
results
(
except
for
banana
and
citrus)
for
all
population
subgroups
based
on
1994
to
1998
CFSII
data
(
Table
6).
The
highest
exposed
subpopulation
incorporating
all
commodities
using
PDP
and
FDA
monitoring
data
without
CMBS
data
(
except
banana
and
citrus)
was
children(
1­
2
years
old)
at
94
percent
of
the
aPAD.
Prior
to
the
calculation
of
these
risk
estimates,
residues
in
poultry
were
the
key
contributors
to
the
risks
for
various
populations.
Since
then,
Bayer
has
indicated
that
poultry
uses
will
be
deleted
(
i.
e.,
poultry
uses
were
not
considered
in
this
assessment).
As
such,
it
appears
that
consumption
of
strawberries
is
the
critical
contributor
to
acute
dietary
risks.
A
sensitivity
analysis
was
conducted
by
eliminating
strawberries
and
by
eliminating
crops
where
no
detectable
residues
were
found
(
Table
7).
This
analysis
showed
that
risk
estimates
were
not
significantly
affected
by
assuming
zero
in
place
of
½
LOD
on
samples
reported
as
not
detectable.
Eliminating
strawberries
reduced
exposures
of
children
(
1­
2
years)
to
71
percent
of
the
aPAD.

Table
6.
Results
of
Acute
Dietary
Exposure
Analysis
(
Market
Basket
Survey
Data
Not
Included
except
for
citrus
and
bananas)

Population
Subgroup**
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.01
0.000474
5
0.001303
13
0.004294
43
All
Infants
(<
1
year
old)
0.01
0.000761
8
0.002772
28
0.006747
67
Children
1­
2
years
old
0.01
0.001886
19
0.003526
35
0.009390
94
Children
3­
5
years
old
0.01
0.001230
12
0.002433
24
0.008084
81
Children
6­
12
years
old
0.01
0.000748
7
0.001474
15
0.005434
54
Youth
13­
19
years
old
0.01
0.000367
4
0.000826
8
0.003248
32
Adults
20­
49
years
old
0.01
0.000299
3
0.000752
8
0.002925
29
Females
13­
49
years
old
0.01
0.000284
3
0.000751
8
0.003227
32
Adults
50+
years
old
0.01
0.000287
3
0.000786
8
0.002971
30
**
The
values
for
the
highest
exposed
population
are
bolded.
41
Table
7.
Results
of
the
Carbaryl
Sensitivity
Analyses.

Acute
­
All
Commodities
at
the
99.9th
percentile
of
exposure
(
Market
Basket
Survey
Data
Not
Included)

Pop.
Subgroup**
All
commodities
No
Decompositing
Eliminating
Strawberries
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.004294
43
0.004291
43
0.003614
36
All
Infants
(<
1
year
old)
0.006747
67
0.006747
67
0.006675
67
Children
1­
2
years
old
0.009390
94
0.009359
93
0.007110
71
Children
3­
5
years
old
0.008084
81
0.008075
81
0.006126
61
Children
6­
12
years
old
0.005434
54
0.005434
54
0.003952
40
Youth
13­
19
years
old
0.003248
32
0.003243
32
0.002359
24
Adults
20­
49
years
old
0.002925
29
0.002919
29
0.002368
24
Females
13­
49
years
old
0.003227
32
0.003219
32
0.002424
24
Adults
50+
years
old
0.002971
30
0.002961
30
0.002564
26
**
The
values
for
the
highest
exposed
population
are
bolded.

When
the
CMBS
data
were
included
in
the
assessment,
the
acute
risk
picture
for
carbaryl
was
not
impacted
(
Table
8).
Children
(
1­
2
years
old)
and
children
(
3­
5
years
old)
all
infants
had
the
highest
associated
risk
levels
at
86
percent
and
77
percent
of
the
aPAD,
respectively.
At
the
present
time,
information
from
the
industry­
sponsored
Carbamate
Market
Basket
Survey
has
been
approved
for
use
in
dietary
risk
assessments
with
appropriate
characterization
of
uncertainties
associated
with
the
conduct
of
the
study.
Hence,
the
use
of
these
data
in
this
assessment
should
be
considered
with
associated
caveats
(
e.
g.,
rubbing
fruit).

Table
8.
Results
of
Acute
Dietary
Exposure
Analysis
With
Market
Basket
Survey
Data
Included*

Population
Subgroup
**
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.01
0.000455
5
0.001248
12
0.004003
40
All
Infants
(<
1
year
old)
0.01
0.000688
7
0.002394
24
0.005600
56
Children
1­
2
years
old
0.01
0.001836
18
0.003371
34
0.008590
86
Children
3­
5
years
old
0.01
0.001189
12
0.002237
22
0.007732
77
Children
6­
12
years
old
0.01
0.000725
7
0.001382
14
0.005217
52
Youth
13­
19
years
old
0.01
0.000360
4
0.000801
8
0.003182
32
Adults
20­
49
years
old
0.01
0.000289
3
0.000728
7
0.002801
28
Females
13­
49
years
old
0.01
0.000275
3
0.000705
7
0.003016
30
Table
8.
Results
of
Acute
Dietary
Exposure
Analysis
With
Market
Basket
Survey
Data
Included*

Population
Subgroup
**
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
42
Adults
50+
years
old
0.01
0.000272
3
0.000735
7
0.002691
27
*
Market
basket
survey
data
included
for
apple,
banana,
broccoli,
grape,
lettuce,
orange,
peach
and
tomato.

**
The
values
for
the
highest
exposed
population
are
bolded.

4.2.3
Chronic
Dietary
Risk
Assessment
Chronic
dietary
risks
were
calculated
using
the
same
equations
as
described
above
for
the
acute
dietary
risk
estimates
with
different
inputs
appropriate
for
this
exposure
duration.
Chronic
dietary
risks
are
not
of
concern
as
risks
were
<
1
percent
of
the
cPAD
for
all
population
subgroups
considered
(
Table
9).
The
Carbamate
Market
Basket
Survey
(
CMBS)
was
not
used
in
the
calculation
of
chronic
dietary
risks
because
risks
were
low
without
considering
it
and
it
is
not
appropriate
because
it
is
for
single
serving
data.

Table
9.
Results
of
Chronic
Dietary
Exposure
Analysis
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.01
0.000024
<
1
All
Infants
(<
1
year
old)
0.01
0.000055
<
1
Children
1­
2
years
old
0.01
0.000076
<
1
Children
3­
5
years
old
0.01
0.000054
<
1
Children
6­
12
years
old
0.01
0.000029
<
1
Youth
13­
19
years
old
0.01
0.000015
<
1
Adults
20­
49
years
old
0.01
0.000020
<
1
Females
13­
49
years
old
0.01
0.000018
<
1
Adults
50+
years
old
0.01
0.000021
<
1
4.2.4
Cancer
Dietary
Risk
Assessment
The
following
equations
were
used
to
calculate
dietary
exposure
and
cancer
risk
using
the
Q1*
approach
for
carbaryl
(
i.
e.,
linear,
low
dose
extrapolation).
Cancer
risks
were
only
calculated
for
the
general
population.

Dietary
exposure
(
mg/
kg/
day)
=
consumption
x
residue
Dietary
cancer
risk
=
average
food
exposure
(
mg/
kg/
day)
x
Q1*
(
mg/
kg/
day)­
1
Risk
estimates
above
1
x
10­
6
are
considered
to
be
of
concern.
Results
indicate
a
maximum
lifetime
risk
43
of
2.14x10­
8
based
on
the
exposures
calculated
for
the
general
US
population
(
Table
9).
The
Carbamate
Market
Basket
Survey
(
CMBS)
was
not
used
in
the
calculation
of
chronic
dietary
risks.

4.2.5
Characterization/
Uncertainties
of
the
Dietary
Risk
Estimates
In
the
course
of
conducting
a
Tier
3/
4
dietary
exposure
analysis,
decisions
are
made
regarding
the
following:
the
residue
data
used
in
the
analysis
(
e.
g.,
field
trials,
monitoring
data,
etc.),
refinements
incorporated
in
DEEM­
FCID
 
such
as
%
CT
and
processing
factors,
sensitivity
analyses,
and
a
variety
of
other
issues
which
may
be
chemical­
or
crop­
specific.
Characterization
of
this
assessment
and
associated
uncertainties
include:

°
The
results
of
the
Critical
Exposure
Contribution
analysis
showed
that
strawberries
comprised
a
large
percentage
of
the
residues
found
in
the
tail
end
of
acute
exposure
for
children.
Strawberry
residues
are
from
USDA
PDP
data.

°
This
assessment
is
highly
refined.
Very
little
field
trial
data
were
used
and
processing,
cooking
and
washing
factors
were
incorporated
to
the
greatest
extent
possible.
Nonetheless,
further
refinement
could
be
carried
out
with
the
submission
of
additional
washing,
cooking,
canning,
and
other
processing
studies
and
with
monitoring
data
for
commodities
where
field
trial
data
were
found
to
be
best
source
of
residue
data.

4.3
Estimated
Environmental
Concentrations
In
Water
The
Environmental
Fate
and
Effects
Division
(
EFED)
provided
an
analysis
of
the
available
monitoring
data
and
a
screening­
level
assessment
using
simulation
models
to
estimate
the
potential
Estimated
Environmental
Concentrations
(
EECs)
of
carbaryl
in
ground
and
surface
water
(
D288455).
Section
4.3.1:
Environmental
Fate
Characteristics
provides
a
summary
of
the
fate
characteristics
of
carbaryl.
Section
4.3.2:
Monitoring
Data
provides
a
summary
of
the
monitoring
data
that
were
considered
in
this
assessment.
Section
4.3.3:
Modeling
EECs
presents
the
EECs
used
for
comparison
to
the
DWLOCs
(
Drinking
Water
Levels
of
Concern)
calculated
for
the
aggregate
risk
assessment
(
presented
in
Section
5
below).
[
Note:
For
the
acute
dietary
assessment,
DWLOCs
were
not
calculated
because
a
distribution
of
water
concentrations
was
directly
incorporated
into
DEEM/
FCID.
Further
explanation
is
provided
below.]

4.3.1
Environmental
Fate
Characteristics
Carbaryl
is
considered
to
be
mobile
and
not
likely
to
persist
or
accumulate
in
the
environment
and
its
degradate,
1­
naphthol,
appears
to
be
less
persistent
and
mobile
than
carbaryl
itself.
Under
acidic
conditions
with
limited
microbial
activity
they
may
persist.

Carbaryl
dissipates
in
the
environment
by
abiotic
and
microbially
mediated
degradation.
The
major
degradation
products
are
CO2
and
1­
naphthol,
which
is
further
degraded
to
CO2.
Carbaryl
is
stable
to
hydrolysis
in
acidic
conditions
but
hydrolyzes
in
neutral
(
t1/
2
=
12
days)
and
alkaline
environments
(
pH=
9,
t1/
2
=
3.2
days).
Carbaryl
is
degraded
by
photolysis
in
water
(
t1/
2
=
21
days).
Under
aerobic
conditions,
the
compound
degrades
rapidly
by
microbial
metabolism,
with
half
lives
of
4
to
5
days
in
soil
44
and
aquatic
environments.
In
anaerobic
environments
metabolism
is
much
slower
with
½
lives
on
the
order
of
2
to
3
months.
Carbaryl
is
mobile
in
the
environment
(
Kf
=
1.7
to
3.5).

The
major
metabolite
of
carbaryl
degradation
by
abiotic
and
microbially
mediated
processes
is
1­
naphthol.
This
degradate
represented
up
to
67
percent
of
the
applied
carbaryl
in
degradation
studies.
It
is
also
formed
in
the
environment
by
degradation
of
napthalene
and
other
polyaromatic
hydrocarbons.
Only
limited
information
is
available
for
the
environmental
transport
and
fate
of
1­
naphthol.
While
guideline
studies
were
not
specifically
submitted
for
1­
naphthol,
open
literature
data
suggest
it
is
less
persistent
and
less
mobile
than
carbaryl.

4.3.2
Monitoring
Data
Monitoring
data
for
groundwater
and
surface
water
are
available
but
are
limited
in
terms
of
its
usefulness
for
quantitative
assessment.
As
reported
in
the
U.
S.
E.
P.
A.
Pesticides
in
Groundwater
Database,
carbaryl
was
detected
in
0.4%
of
wells
sampled.
Carbaryl
was
detected
in
California
(
2
out
of
1433
wells),
Missouri
(
11
out
of
325
wells),
New
York
(
69
out
of
21027
wells)
Rhode
Island
(
13
out
of
830
wells)
and
Virginia
(
11
out
of
138
wells)
(
Jacoby
et
al.,
1992).
The
maximum
concentration
detected
was
610
µ
g/
L
in
NY,
though
typically
the
measured
concentrations
were
significantly
lower.

The
EPA
STORET
database
contains
9389
records
indicating
that
analysis
was
done
for
carbaryl.
Of
these,
only
4
were
reported
concentrations
above
the
detection
limits.
These
analyses
were
all
from
one
well
in
Cleveland,
OK
in
1988.
The
4
reported
concentrations
were
between
0.8
and
1
ppb.

Carbaryl
was
detected
at
greater
than
the
detection
limit
(
0.003
:
g/
L)
in
1.1%
of
groundwater
samples
in
the
USGS
NAWQA
program.
The
maximum
observed
concentration
was
0.021
:
g/
L.
Detections
were
mainly
from
three
settings:
wheat
(
5.8
%
of
well
samples
from
wheat
land
use),
orchards
and
vineyards
(
1.7
%
of
well
samples
from
orchard
and
vineyard
land
use),
and
urban
(
1.8%
of
urban
groundwater
samples).
A
number
of
field
studies
have
reported
detectable
carbaryl
concentrations
in
surface
waters.
Because
of
limitation
in
the
analytical
methods
used,
there
is
some
question
as
to
the
accuracy
of
carbaryl
analysis.
Poor
analytical
methods
probably
have
resulted
in
lower
detection
rates
and
lower
concentrations
than
actually
present.

Carbaryl
was
detected
in
surface
water
in
46%
of
the
36
NAWQA
study
units
between
1991
and
1998.
Carbaryl
(
along
with
diazinon)
was
one
of
the
two
most
widely
detected
insecticides.
A
significant
portion
of
the
total
carbaryl
applied
was
apparently
transported
to
streams.
Out
of
5220
surface
water
samples
analyzed,
1082
or
about
21
percent
were
reported
as
having
detections
greater
than
the
minimum
detection
limit
(
MDL).
The
maximum
reported
concentration
was
5.5
ug/
L.
For
samples
with
positive
detections
the
mean
concentration
was
0.11
:
g/
L
with
a
standard
deviation
of
0.43
:
g/
L.
In
areas
with
high
agricultural
use,
the
load
measured
in
surface
waters
was
relatively
consistent
across
the
country
at
about
0.1
percent
of
the
amount
used
in
the
basins.
Streams
draining
urban
areas
showed
more
frequent
detections
and
higher
concentrations
than
streams
draining
agricultural
or
mixed
land
use
areas.

Bayer
CropScience
submitted
results
of
an
on­
going
surface
water
monitoring
study
of
carbaryl
residues
in
surface
water
in
areas
with
high
agricultural
and
residential
use.
In
this
drinking
water
study,
45
raw
water
was
collected
at
16
sites
in
agricultural
areas
and
four
in
areas
draining
suburban
areas.
Samples
at
municipal
water
treatment
facilities
were
collected
for
3
years.
When
raw
water
showed
positive
detections
for
carbaryl,
finished
water
samples
collected
at
the
same
time
were
analyzed.
This
study
provides
useful
information
on
measured
concentrations
of
carbaryl
in
selected
surface
waters
of
the
United
States.
Based
on
our
analysis
of
sites
selected,
we
do
not
concur,
however,
that
these
results
can
be
used
directly
in
the
dietary
risk
assessment
to
represent
exposure
to
carbaryl
in
surface
water
source
drinking
water.
The
information
from
this
study
does
provide
good
quality
data
that
can
be
used
in
association
with
other
monitoring
data
sets
to
characterize
carbaryl
exposure.
These
data
will
be
used
in
conjunction
with
other
monitoring
data,
to
evaluate
conservatism
in
surface
water
modeling
estimates
of
carbaryl
exposure
from
surface­
water
source
drinking
water.
Several
major
drawbacks
to
the
quantitative
use
of
these
data
are:

°
With
only
16
sites
to
represent
vulnerable
surface
water
bodies
for
selected
agricultural
uses
(
really
15,
as
the
LA
site
was
selected
to
represent
population
exposure
not
because
source
waters
were
vulnerable)
and
four
suburban
sites,
this
study
is
not
likely
to
provide
comprehensive
coverage
of
even
all
high
carbaryl
usage
sites,
given
the
great
geographic
diversity
of
carbaryl
use
areas
and
carbaryl
uses.

°
We
do
not
concur
that
sites
sampled
represent
the
"
the
highest
probable
risk
of
human
exposure
to
carbaryl
in
surface
water
in
each
state".
Based
on
our
analysis
of
carbaryl
use
areas,
we
would
conclude
that
some
of
the
agricultural
sites
monitored
are
not
particularly
vulnerable.

°
The
monitoring
interval
(
one
week
to
two
weeks)
is
unlikely
to
capture
peak
concentrations
necessary
for
estimating
acute
dietary
risk,
given
the
variable
nature
of
concentration
distributions.

4.3.3
Modeling
EECs
Because
of
the
relatively
limited
persistence
of
the
compound
in
the
environment,
it
is
highly
unlikely
that
the
non­
targeted
monitoring
studies
which
have
been
completed
detected
the
maximum
concentrations
that
occur.
As
a
result,
the
non­
targeted
monitoring
data
have
been
determined
to
be
of
limited
utility
in
developing
estimated
environmental
concentrations
(
EECs)
for
ecological
and
human
health
risk
assessment.
Therefore,
computer
modeling
was
used
to
estimate
surface
water
and
groundwater
concentrations
that
could
be
expected
from
normal
agricultural
use
(
Table
10).
The
results
of
the
modeling
are
supported
by
the
available
monitoring
data.
These
results
have
been
characterized
as
conservative,
though
not
unreasonable
estimates
of
possible
concentrations
in
drinking
water.

Surface
Water
Modeling:
Computer
modeling
with
the
EPA
PRZM3.12
and
EXAMS
2.98.04
programs
were
used
to
estimate
the
concentration
of
carbaryl
in
surface
water.
Index
reservoir
scenarios
corrected
for
Percent
Cropped
Area
(
PCA)
for
representative
crops
were
used.
Three
different
application
rates
were
used
in
modeling:
the
maximum
allowed
on
the
label
for
the
specific
crop,
an
"
average"
rate
and
the
maximum
rate
reported
to
actually
be
used.
EECs
varied
greatly
depending
on
the
geographic
location,
crop
and
application
rate.
The
maximum
calculated
acute
and
chronic
EECs
(
316
ppb
and
14.2
ppb,
respectively)
resulted
from
use
on
citrus
in
Florida.
Modeling
"
average"
and
maximum
resulting
use
rates
gave
EEC
values
generally
40­
60%
lower
than
maximum.
The
source
of
46
drinking
water
in
relation
to
the
EECs
must
be
carefully
considered
when
using
these
data.
In
this
case,
the
results
for
Florida
provided
the
highest
estimates,
however;
in
Florida
the
majority
of
drinking
water
is
derived
from
groundwater
(>
90%)
so
high
surface
water
concentrations
do
not
necessarily
indicate
high
exposure.
As
a
result,
both
Florida
and
the
results
for
Pennsylvania
apples
(
acute
EEC
=
62.9
ppb)
and
Ohio
sweetcorn
(
chronic
EEC
=
5.5
ppb)
have
been
considered
in
the
aggregate
assessment
(
see
Section
5.0
for
more
information).
The
EECs
for
Pennsylvania
apples
and
Ohio
sweetcorn
provide
the
next
highest
values
for
the
acute
and
chronic
estimates,
respectively.
For
the
acute
dietary
assessment,
DWLOCs
were
not
calculated
because
a
distribution
of
water
concentrations
generated
using
PRZM/
EXAMS
was
directly
incorporated
into
DEEM/
FCID.
This
means
that
the
acute
EECs
were
not
directly
used
for
risk
assessment
purposes.
They
have
been
presented
here
for
comparative
purposes
and
to
provide
additional
characterization.

Ground
Water
Modeling:
SCI­
GROW
2.2
was
used
to
calculate
a
groundwater
screening
exposure
value
to
be
used
in
determining
the
potential
risk
to
human
health.
Carbaryl
chemical
properties
are
outside
the
range
of
values
for
which
SCI­
GROW
was
developed
(
i.
e.,
aerobic
metabolism
is
faster
and
its
partition
coefficient
is
larger
which
equates
to
less
leaching
than
the
reference
compounds
­
both
factors
indicate
carbaryl
degrades
faster).
SCI­
GROW
estimates
for
groundwater
EECs
may
not
predict
with
complete
accuracy,
maximum
levels
because
the
concentrations
calculated
are
90
day
averages.
It
is
possible;
therefore,
that
groundwater
concentration
peaks
could
not
be
identified.
Groundwater
levels
are
anticipated,
however,
to
be
more
stable
over
time
than
surface
water
concentrations.

Table
10:
Carbaryl
Drinking
Water
Estimated
Environmental
Concentrations
(
EECs)

Crop
Application
Rate
Descriptor
Number
of
Applications
per
Year
Pounds
A.
I.
per
application
Water
Acute
(
ppb)
(
1
in
10
year
peak
single
day
concentration)
Water
Chronic
(
ppb)
(
1
in
10
year
annual
average
concentration)

Source:
Surface
Water
(
PRZM/
EXAMs)

Sweet
Corn
(
OH)
(
PCA
=
0.46)
Maximum1
8
2
57.3
5.53
*

Average2
2
3.4
49.8
2.31
Maximum3
Reported
3
1
25.6
1.26
Source:
Surface
Water
(
PRZM/
EXAMs)

Field
Corn
(
OH)
(
PCA
=
0.46)
Maximum1
4
2
51.3
2.72
Average2
2
1
14.6
0.68
Maximum3
Reported
2
1.5
21.9
1.02
Source:
Surface
Water
(
PRZM/
EXAMs)

Apples
(
PA)
(
PCA
=
0.87)
Maximum1
5
2
62.9
*
2.20
Average2
2
1.2
23.4
0.63
Maximum3
Reported
2
1.6
34.4
1.04
Source:
Surface
Water
(
PRZM/
EXAMs)

Sugar
Beats
(
MN)
(
PCA
=
0.87)
Maximum1
2
1.5
48.2
2.16
Average2
1
1.5
13.6
0.73
Maximum3
Reported
1
1.2
10.8
0.58
Table
10:
Carbaryl
Drinking
Water
Estimated
Environmental
Concentrations
(
EECs)

Crop
Application
Rate
Descriptor
Number
of
Applications
per
Year
Pounds
A.
I.
per
application
Water
Acute
(
ppb)
(
1
in
10
year
peak
single
day
concentration)
Water
Chronic
(
ppb)
(
1
in
10
year
annual
average
concentration)

47
Source:
Surface
Water
(
PRZM/
EXAMs)

Citrus
(
FL)
(
PCA
=
0.87)
Maximum1
4
5
316
*
14.2
*

Average2
2
3.4
203
7.33
Maximum3
Reported
3
4.3
272
10.0
Source:
Surface
Water
(
NAWQA)
5.5
(
Maximum
Observed
)
NA
Source:
Surface
Water
(
Bayer
Monitoring
Data)
0.18
(
Maximum
Observed)
NA
Source:
Groundwater
(
SCI­
GROW)
Maximum1
5
4
0.8
0.8
Source:
Groundwater
(
NAWQA
Monitoring
Data)
0.02
0.02
1
Maximum
application
rate
on
label
2
Average
application
rate
from
Quantitative
Usage
Analysis
for
Carbaryl,
prepared
July
21,
1998
by
Frank
Hernandez,
OPP/
BEAD
3
Maximum
rate
of
application
reported
in
DOANES
survey
data
*
=
Value
used
for
risk
assessment.
Note
acute
EECs
were
not
used
directly
in
the
risk
assessment.
A
ranking
approach
was
used
based
on
these
EECs
to
determine
which
water
concentration
distributions
were
selected
for
direct
incorporation
into
DEEM/
FCID
for
the
acute
aggregate
assessment.

4.4
Residential
Risk
Assessment
The
residential
risk
assessment
addresses
exposures
that
individuals
receive
through
their
use
of
consumer
products
that
contain
carbaryl
and
those
exposures
one
could
receive
from
frequenting
areas
that
have
been
previously
treated
with
carbaryl
such
as
a
home
lawn,
a
garden,
or
public
areas
such
as
a
golf
course.
Carbaryl
can
also
be
applied
in
wide
area
treatments
such
as
on
oyster
beds
or
as
a
mosquito
adulticide.
These
exposures
have
also
been
addressed
in
this
assessment.
The
Occupational
and
Residential
Exposure
Assessment
(
D287251)
was
prepared
by
Jeff
Dawson
with
the
exception
of
the
tobacco
assessment
completed
by
Dr.
Virginia
Dobozy.
The
document
D287251
contains
detailed
descriptions
of
the
data
used,
methods,
and
risks
calculated
for
each
scenario.
Please
refer
to
that
document
for
more
specific
information.

Section
4.4.1:
Home
Uses
provides
more
specific
information
pertaining
to
how
carbaryl
consumer
products
are
used
which
was
considered
in
addition
to
the
information
presented
above
in
Section
4.1:
Summary
of
Registered
Uses
because
it
applied
more
directly
to
the
development
of
the
residential
risk
assessment.
Section
4.4.2:
Deterministic
Residential
Handler
Risk
Assessment
describes
the
data,
methods,
and
risk
results
(
both
cancer
and
noncancer)
associated
with
the
use
of
consumer
products
which
contain
carbaryl.
Section
4.4.3:
Deterministic
Residential
Postapplication
Risk
Assessment
describes
the
data,
methods,
and
risk
results
associated
with
exposures
to
the
general
population
that
occur
from
frequenting
treated
areas.
Section
4.4.4:
Risks
Based
On
Suburban
Resident
48
Biological
Monitoring
Study
describes
the
biomonitoring
data
(
and
supporting
data),
methods,
and
risk
results
(
both
cancer
and
noncancer)
associated
with
the
monitored
individuals.
Section
4.4.5:
Residential
Risk
Characterization
provides
information
pertaining
to
the
quality
of
the
assessment
including
discussions
of
the
data
used,
uncertainties
with
the
methods,
and
any
other
information
that
might
be
used
to
describe
the
quality
of
the
results.
Section
4.4.6:
Risks
Associated
With
Use
In
Tobacco
describes
how
risks
were
calculated
for
smokers
who
may
consume
carbaryl
treated
tobacco
in
their
cigarettes.
Section
4.4.7:
Other
Residential
Uses
characterizes
other
potential
sources
of
exposure
outside
of
those
quantitatively
described
in
this
assessment.

For
clarity,
the
term
"
deterministic"
has
been
used
here
to
generically
refer
to
the
assessments
based
on
the
standard
Agency
approach
for
calculating
residential
exposure
(
i.
e.,
point
estimates).
The
underlying
purpose
of
this
description
is
to
differentiate
these
risks
from
those
associated
with
the
suburban
resident
biological
monitoring
study.

4.4.1
Home
Uses
Carbaryl
is
a
widely­
used
consumer
product.
Available
products
include
liquids,
wettable
powders,
and
dusts
for
insect
control
on
fruits,
vegetables,
ornamentals,
and
lawns.
Products
for
flea
control
on
pets
are
also
available.
The
equipment
used
in
applications
may
include
dust
shaker
cans,
garden
hose
end
sprayers,
trigger
sprayers,
low
pressure
handwands,
belly
grinders,
push­
type
spreaders,
aerosol
cans,
and
pet
collars.
In
addition
to
the
information
presented
in
Section
4.1:
Summary
Of
Registered
Uses,
Bayer
at
the
time
of
the
September
24,
1998
SMART
Meeting
also
presented
additional
information
that
was
key
to
the
residential
risk
assessment
based
on
the
Sevin
User
Survey.
Results
from
the
Residential
Exposure
Joint
Venture
survey
were
also
considered
although
it
should
be
noted
that
these
results
do
not
significantly
alter
the
factors
used
for
the
Agency's
deterministic
assessments
(
based
on
Nako,
2/
5/
03,
D284657).
Carbaryl
accounted
for
approximately
9
percent
of
the
total
residential
insecticide
market
and
was
ranked
fourth
on
the
list
behind
the
pyrethroids,
chlorpyrifos,
and
diazinon.
In
addition,
the
registrant
also
presented
the
following:

°
According
to
the
registrant,
insect
control
on
vegetables
(~
58%
of
users),
annuals
(~
50%
of
users),
lawns
(~
35%
of
users),
trees/
shrubs
(~
34%
of
users)
account
for
the
majority
of
homeowner
uses
for
carbaryl.
Pet
uses
also
accounted
for
~
13
percent
of
users.

°
The
annual
frequency
of
use,
for
all
crops/
targets,
was
reported
to
be
at
the
60th
percentile
for
1
to
2
times
per
year
and
at
the
84th
percentile
for
5
times
per
year.

°
Aphids,
ants,
fire
ants,
fleas,
and
slugs/
snails
are
predominant
pests
controlled
by
residential
carbaryl
users
(~
30
down
to
15%
of
users,
respectively).

°
Most
(
75%)
of
vegetable
gardens
treated
with
carbaryl
are
<
800
ft2
but
~
8
percent
are
between
800
and
1500
ft2,
~
9
percent
are
between
1500
and
5000
ft2,
and
~
6
percent
are
greater
than
5000
ft2.
Tomatoes,
peppers,
cucumbers,
beans,
and
fruit
trees
represent
the
most
treated
garden
plants.

°
Most
(
82%)
of
flower
gardens
treated
with
carbaryl
are
<
500
ft2
but
~
10
percent
are
between
500
and
1200
ft2,
and
~
8
percent
are
greater
than
1200
ft2.
Roses,
shrubs,
and
certain
annuals
represent
49
the
most
treated
flowering/
ornamental
plants.

°
Dusts
(
65%)
and
liquid
concentrates
(
25%)
account
for
most
carbaryl
sales
in
the
residential
annual
market
of
2
million
pounds
per
year.

°
According
to
the
results
of
the
Residential
Exposure
Joint
Venture
survey,
carbaryl
use
on
lawns
is
not
predominant
in
the
residential
market.
Uses
on
vegetables
and
ornamentals
account
for
the
most
use
in
the
residential
marketplace.
Approximately
1.2
percent
of
the
general
United
States
population
uses
carbaryl
on
lawns
and
about
½
of
that
is
for
spot
treatments
which
would
be
considered
a
negligible
exposure
scenario
by
the
Agency
(
i.
e.,
about
0.5
percent
of
the
population
uses
carbaryl
on
lawns
in
a
way
that
creates
a
significant
exposure
source).
Approximately
4
to
5
percent
of
the
United
States
population
uses
carbaryl
on
vegetables
and
ornamentals.
Conditional
probabilities
indicate
that
if
a
turf
application
is
made,
then
at
most
18
percent
of
the
time
that
individual
will
also
treat
their
vegetables
or
44
percent
of
the
time
at
most
that
individual
will
also
treat
their
ornamentals.
The
survey
indicated
also
that
about
67
percent
of
the
general
population
uses
pesticides
and
about
8.9
percent
of
all
households
use
products
containing
carbaryl.

4.4.2
Deterministic
Residential
Handler
Risk
Assessment
The
anticipated
use
patterns
and
current
labeling
indicate
17
major
residential
exposure
scenarios,
based
on
the
types
of
equipment
and
techniques,
in
which
homeowners
can
be
exposed
to
carbaryl
during
the
application
process.
The
quantitative
exposure/
risk
assessment
developed
for
residential
handlers
is
based
on
these
scenarios.
For
most
scenarios,
multiple
uses
and
application
rates
were
considered
for
a
total
of
54
distinct
combinations.
The
17
major
scenarios
include:

(
1)
Garden
Uses:
Ready­
to­
use
Trigger
Sprayer;
(
2)
Garden
Uses:
Ornamental
Duster;
(
3)
Garden
Uses:
Hose­
end
Sprayer;
(
4)
Garden
Uses:
Low
Pressure
Handwand;
(
5)
Tree/
ornamental
Uses:
Low
Pressure
Handwand;
(
6)
Tree/
ornamental
Uses:
Hose­
end
Sprayer;
(
7)
Garden
Uses:
Backpack
Sprayer;
(
8)
Lawncare
Liquid
Uses:
Hose­
end
Sprayer;
(
9)
Pet
(
Dog
and
Cat)
Uses:
Dusting;
(
10)
Pet
(
Dog
and
Cat)
Uses:
Liquid
Application;
(
11)
Lawncare
Granular
and
Bait
Uses:
Belly
Grinder;
(
12)
Lawncare
Granular
and
Bait
Uses:
Push­
type
Spreader;
(
13)
Ornamental
and
Garden
Uses:
Granulars
and
Baits
By
Hand;
(
14)
Various
Pest
Uses:
Aerosol
Cans;
(
15)
Pet
(
Dog
and
Cat)
Uses:
Collars;
(
16)
Garden
and
Ornamental
Uses:
Sprinkler
Can;
and
(
17)
Garden
and
Ornamental
Uses:
Paint­
on.

Data
and
Assumptions
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
residential
handler
risk
assessments,
as
described
below.
5
PHED
is
a
generic
database,
which
includes
the
results
of
over
100
exposure
studies,
developed
by
US
EPA,
Pest
Management
Regulatory
Agency/
Health
Canada
and
the
California
Department
of
Pesticide
Regulation,
in
cooperation
with
the
pesticide
industry.

50
°
Label
maximum
use
rates
and
use
information
specific
to
residential
products
served
as
the
basis
for
the
risk
calculations.
If
additional
information,
such
as
average
or
typical
rates,
were
available,
these
values
were
used
as
well
in
order
to
allow
risk
managers
to
make
a
more
informed
risk
management
decision.
Average
application
rates
were
available
from
the
SMART
meeting
and
BEAD's
Quantitative
Usage
Analysis
(
QUA).
These
data
indicate
that
in
most
cases,
average
application
rates
differ
from
maximum
application
rates
by
a
factor
of
approximately
two.
The
average
application
rates
identified
from
the
studies
conducted
by
Bayer
CropScience
were
also
considered.

°
The
exposure
duration
(
i.
e.,
years
per
lifetime)
values
in
the
cancer
risk
assessment
are
consistent
with
those
used
for
other
chemicals
(
i.
e.,
50
years
with
home­
use
chemicals
and
70
year
lifetime).
Cancer
risks
were
calculated
assuming
one
exposure
per
year.
In
addition
the
number
of
days
of
exposure
per
year
which
could
occur
under
the
ceiling
established
by
an
acceptable
risk
level
of
1x10­
6
were
also
calculated.
These
estimates
can
then
be
compared
to
the
annual
use
frequency
of
1­
2x
(
60th
percentile)
and
5x
(
84th
percentile)
presented
at
the
SMART
meeting.

°
The
unit
exposure
values
used
in
this
assessment
were
based
on
three
carbaryl­
specific
residential
handler
studies
which
quantified
exposures
during
pet
treatments
with
a
dust;
applications
to
gardens
using
a
ready­
to­
use
trigger
sprayer,
a
dust,
a
hose­
end
sprayer,
and
a
low­
pressure
handwand;
and
during
applications
to
trees
using
a
low­
pressure
handwand
and
a
hose­
end
sprayer.
Two
other
studies
completed
by
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
and
the
Pesticide
Handlers
Exposure
Database
(
Version
1.1
August
1998)
(
PHED)
5
were
also
used
as
sources
of
surrogate
information.
[
Note
to
Risk
Managers:
There
is
no
data
compensation
issue
associated
with
the
use
of
the
ORETF
data
in
the
carbaryl
risk
assessment
because
Bayer
CropScience,
the
registrant
for
carbaryl,
is
a
member
of
the
ORETF].
Summaries
of
the
five
studies
are
included
in
the
Occupational
and
Residential
Risk
Assessment
(
D287251).
These
studies
are
all
considered
to
be
of
high
quality.
The
quality
of
the
data
in
PHED
varies
from
scenarios
that
meet
study
guideline
requirements
to
others
where
a
limited
number
of
poor
quality
data
points
are
available.
However,
in
all
cases,
the
data
used
represent
the
best
available
for
the
scenario.
The
PHED
unit
exposure
values
range
between
geometric
mean
and
median
of
available
exposure
data.
When
data
from
other
studies
were
used,
the
appropriate
statistical
measure
of
central
tendency
was
used.
Central
tendency
values,
coupled
with
other
inputs
used
by
HED,
are
thought
to
result
in
conservative,
deterministic
estimates
of
risk.
For
pet
collars
only,
a
scenario
from
the
SOPs
For
Residential
Exposure
Assessment
not
based
on
monitoring
data
was
used
to
calculate
exposures.
The
factors
derived
from
the
SOPs
are
generally
thought
to
be
conservative.

°
Average
body
weight
of
adult
handlers
is
assumed
to
be
70
kg
because
the
toxicology
endpoint
values
used
for
the
risk
assessments
are
appropriate
for
average
adult
body
weight
representing
the
general
population.
No
specific
effects
were
observed
consistently
in
the
toxicology
studies
to
51
indicate
an
increased
sensitivity
of
one
gender
over
another.

°
Homeowner
handler
assessments
were
completed
based
on
individuals
wearing
shorts
and
shortsleeved
shirts.

°
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;

°
Calculations
were
based
on
scenarios
in
the
home
that
would
reasonably
be
treated
in
a
day
(
but
would
not
necessarily
take
more
than
an
hour
or
two)
such
as
the
size
of
a
lawn,
the
size
of
a
garden,
the
amount
that
can
be
applied
with
a
piece
of
equipment,
or
the
number
of
pets
an
individual
might
keep.
Based
on
Agency
Exposure
SAC
Policy
12:
Recommended
Revisions
To
The
Standard
Operating
Procedures
For
Residential
Exposure
Assessment,
the
daily
volumes
handled
and
area
treated,
excerpted
from
the
policy,
used
in
each
residential
scenario
include
(
along
with
corresponding
inputs
defined
from
carbaryl
studies
and
the
SMART
meeting
for
a
comparative
analysis
to
allow
for
a
more
informed
risk
management
decision):

°
1
container
of
each
ready­
to­
use
non­
pet
product
including
garden
dusts,
trigger
sprayers
and
aerosol
cans
(
scenarios
for
25%
and
50%
used
of
the
total
product
volume
were
also
presented
for
the
trigger
sprayer
and
garden
dust
scenarios
to
allow
for
a
more
informed
risk
management
decision);
°
½
container
of
each
ready­
to­
use
pet
product,
including
dusts
and
liquid
shampoos;
°
1
pet
collar;
°
100
gallons
of
finished
spray
output
for
hose­
end
sprayers;
°
5
gallons
when
mixing/
loading/
applying
liquids
with
a
backpack
sprayer
or
a
low
pressure
handwand
sprayer;
value
was
also
used
for
sprinkler
can
applications;
°
1
gallon
of
paint­
on
solution
for
ornamental/
garden
uses;
°
20,000
square
feet
to
represent
the
surface
area
treated
for
broadcast
applications
to
lawns;
°
1000
square
feet
as
the
treatment
area
for
many
spot
applications
in
lawns,
gardens,
and
ornamentals
(
this
value
used
as
appropriate
when
application
rates
were
based
on
a
square
foot
basis
for
spot­
type
treatments);
and
°
5
mounds
per
day
treated
for
fire
ant
applications.
52
°
For
direct
pet
treatments,
the
Residential
SOPs
were
used
to
define
the
amount
of
chemical
that
can
be
used
to
treat
single
animals,
which
was
then
used
to
calculate
total
human
dose
levels.
The
actual
per
animal
application
rates
used
were
½
of
6
oz.
bottle
for
liquid
shampoo
(
0.5%)
and
½
of
4
lb.
container
for
powders
(
10%).

°
Results
from
the
Residential
Exposure
Joint
Venture
pesticide
user
survey
were
summarized
and
evaluated
by
(
Nako,
2/
5/
03,
D284657).
It
is
important
to
note
that
the
results
of
this
survey
do
not
conflict
with
the
input
values
that
were
used
in
the
Agency's
deterministic
risk
assessments.

4.4.2.1
Deterministic
Residential
Handler
Noncancer
Risks
Noncancer
risks
were
calculated
using
the
Margin
of
Exposure
(
MOE)
approach,
which
is
a
ratio
of
the
body
burden
to
the
toxicological
endpoint
of
concern.
Short­
term
dermal
MOEs
were
calculated
using
a
NOAEL
of
20.0
mg/
kg/
day
from
the
21­
day
dermal
toxicity
study
in
rats
with
technical
material
and
short­
term
inhalation
MOEs
were
calculated
using
a
NOAEL
of
1
mg/
kg/
day
from
the
oral
developmental
neurotoxicity
study
in
rats.
Body
burden
values
were
determined
by
first
calculating
daily
exposures
using
application
parameters
(
i.
e.,
rate
and
area
treated)
along
with
unit
exposure
levels.
Exposures
were
then
normalized
by
body
weight
and
adjusted
for
absorption
factors
(
100
percent
for
both
dermal
and
inhalation)
as
appropriate
to
calculate
average
daily
dose
levels
(
i.
e.,
body
burdens)
as
illustrated
in
equation
below.

Daily
Exposure
(
mg
ai/
day)
=

Unit
Exposure
(
mg
ai/
lb
ai)
x
Application
Rate
(
lb
ai/
A)
x
Daily
Acres
Treated
(
A/
day)

Where:

Daily
Exposure
=
Amount
deposited
on
the
surface
of
the
skin
that
is
available
for
dermal
absorption
or
amount
that
is
inhaled,
also
referred
to
as
potential
dose
(
mg
ai/
day);
Unit
Exposure
=
Normalized
exposure
value
derived
from
August
1998
PHED
Surrogate
Exposure
Table
and
various
referenced
exposure
studies
noted
above
(
mg
ai/
lb
ai);
Application
Rate
=
Normalized
application
rate
based
on
a
logical
unit
treatment
such
as
acres
or
gallons,
maximum
and
typical
values
are
generally
used
(
lb
ai/
A);
and
Daily
Acres
Treated
=
Normalized
application
area
based
on
a
logical
unit
treatment
such
as
acres
(
A/
day)
or
gallons
per
day
can
be
substituted
(
gal/
day).

The
dermal
absorption
factor
of
100
percent
based
on
an
absorption
study
in
rats
was
used
for
all
dermal
calculations
since
no
route­
to­
route
conversion
was
required.
No
specific
inhalation
absorption
factor
is
available
for
carbaryl.
Therefore,
a
factor
of
100
percent
was
used
for
route­
to­
route
calculations
as
is
done
with
all
pesticides.
MOEs
were
calculated
using
the
following
formula.

MOE
=
NOAEL
(
mg
ai/
kg/
day)
Average
Daily
Dose
(
mg
ai/
kg/
day)
53
Where:

MOE
=
Margin
of
exposure,
value
used
to
represent
risk
or
how
close
a
chemical
exposure
is
to
being
a
concern
(
unitless);
Average
Daily
Dose
=
The
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
and
NOAEL
=
No
observed
adverse
effect
level
or
dose
level
in
a
toxicity
study
where
no
observed
adverse
effects
occurred
in
the
study
(
mg
pesticide
active
ingredient/
kg
body
weight/
day).

A
combined
(
dermal
and
inhalation)
MOE
was
determined
because
common
toxicity
(
cholinesterase
inhibition)
endpoints
were
used
to
calculate
dermal
and
inhalation
risks
for
each
exposure
duration.
The
following
formula
was
used
to
calculate
total
MOE
values
by
combining
the
route­
specific
MOEs:

MOE
total
=
1/((
1/
MOE
a)
+
(
1/
MOE
b)
+....
(
1/
MOE
n))

Where:
MOE
a,
MOE
b,
and
MOE
n
represent
MOEs
for
each
exposure
route
of
concern
Short­
term
risks
for
residential
handlers
(
intermediate­
term
scenarios
are
not
thought
to
exist
because
of
the
sporadic
nature
of
applications
by
homeowners)
are
presented
in
Table
11.
For
most
scenarios
(
40
out
of
52),
risks
are
not
of
concern
because
MOEs
exceed
the
required
uncertainty
factor
of
100.
As
expected,
the
scenarios
for
which
MOEs
do
not
meet
or
exceed
100
have
a
relatively
high
unit
exposure
associated
with
them
or
the
amount
of
chemical
used
over
a
day
is
relatively
high
(
based
on
high
application
rates
and/
or
high
amounts
of
area
treated).
The
use
of
dusts
in
gardens
and
for
pet
grooming
along
with
some
liquid
sprays
on
ornamentals
appear
to
be
the
most
problematic
scenarios.
Unlike
the
occupational
handler
scenarios,
the
use
of
different
levels
of
personal
protective
clothing
and
equipment
is
not
considered
for
residential
handlers
because
of
a
lack
of
availability,
training,
and
maintenance.
[
Note:
Scenarios
where
MOEs
are
of
concern
(
i.
e.,
<
100)
for
are
highlighted
in
the
table.]

TABLE
11
CARBARYL
NONCANCER
MOEs
ATTRIBUTABLE
TO
COMBINED
SHORT­
TERM
HOMEOWNER
HANDLER
DERMAL
AND
INHALATION
EXPOSURES
SCEN.
SCEN.
DESCRIPTOR
CROP
TYPE
OR
TARGET
EXPOSURE
FACTORS
DERMAL
MOEs
INHALATION
MOEs
COMBINED
MOEs
APPL.
RATE
(
lb
ai/
unit)
BASIS
FOR
RATE
(
defines
unit
treated)
TREATED
UNITS
ACTIVE
USED
(
lb
ai/
event)

1
Garden:
Ready­
to­
Use
Trigger
Sprayer
(
MRID
444598­
01)
Vegetables/
Ornamentals
0.003
32
oz
bottle
0.126
%
(
769­
977)
0.25
0.00075
34567.9
1393034.8
33730.9
Vegetables/
Ornamentals
0.003
32
oz
bottle
0.126
%
(
769­
977)
0.5
0.0015
17284.0
696517.4
16865.4
Vegetables/
Ornamentals
0.003
32
oz
bottle
0.126
%
(
769­
977)
1
0.003
8642.0
348258.7
8432.7
Average
Study
Use
Rate
0.012
(
lb
ai/
1000
ft2)
1
0.012
2160.5
87064.7
2108.2
TABLE
11
CARBARYL
NONCANCER
MOEs
ATTRIBUTABLE
TO
COMBINED
SHORT­
TERM
HOMEOWNER
HANDLER
DERMAL
AND
INHALATION
EXPOSURES
SCEN.
SCEN.
DESCRIPTOR
CROP
TYPE
OR
TARGET
EXPOSURE
FACTORS
DERMAL
MOEs
INHALATION
MOEs
COMBINED
MOEs
APPL.
RATE
(
lb
ai/
unit)
BASIS
FOR
RATE
(
defines
unit
treated)
TREATED
UNITS
ACTIVE
USED
(
lb
ai/
event)

54
2
Garden/
Ornamental
Dust
(
MRID
444598­
01)
Vegetables/
Ornamentals
0.4
4
lb
bottle
10%
(
239­
1513)
0.25
0.1
94.6
804.6
84.6
Vegetables/
Ornamentals
0.4
4
lb
bottle
10%
(
239­
1513)
0.5
0.2
47.3
402.3
42.3
Vegetables/
Ornamentals
0.4
4
lb
bottle
10%
(
239­
1513)
1
0.4
23.6
201.1
21.2
Average
Study
Use
Rate
0.079
(
lb
ai/
1000
ft2)
1
0.079
119.7
1018.5
107.1
3
Garden:
Hose­
End
(
MRID
444598­
01)
General
Use
(
2%
soln)
0.02
(
lb
ai/
gal
spray
applied)
100
2
20.6
17500.0
20.6
Perimeter
Nuisance
Pest
0.19
(
lb
ai/
1000
ft2)
1
0.19
216.7
184210.5
216.5
Vegetables
0.012
(
lb
ai/
1000
ft2)
1
0.012
3431.4
2916666.7
3427.3
Vegetables/
Ornamentals
0.023
(
lb
ai/
1000
ft2)
1
0.023
1790.3
1521739.1
1788.2
Vegetables
0.047
(
lb
ai/
1000
ft2)
1
0.047
876.1
744680.9
875.1
Average
Study
Use
Rate
0.26
(
lb
ai/
1000
ft2)
1
0.26
158.4
134615.4
158.2
Fire
Ant
0.0075
(
lb
ai/
gal
spray)
100
0.75
54.9
46666.7
54.8
4
Garden:
Low
Pressure
Handwand
(
MRID
444598­
01)
General
Use
(
2%
soln)
0.02
(
lb
ai/
gal
spray
applied)
5
0.1
368.4
77777.8
366.7
Perimeter
Nuisance
Pest
0.19
(
lb
ai/
1000
ft2)
1
0.19
193.9
40935.7
193.0
Vegetables
0.012
(
lb
ai/
1000
ft2)
1
0.012
3070.2
648148.1
3055.7
Vegetables/
Ornamentals
0.023
(
lb
ai/
1000
ft2)
1
0.023
1601.8
338164.3
1594.3
Vegetables
0.047
(
lb
ai/
1000
ft2)
1
0.047
783.9
165484.6
780.2
Average
Study
Use
Rate
0.083
(
lb
ai/
1000
ft2)
1
0.083
443.9
93708.2
441.8
Fire
Ant
0.0075
(
lb
ai/
gal
spray)
5
0.0375
982.5
207407.4
977.8
5
Trees/
Ornamentals:
Low
Pressure
Handwand
(
MRID
445185­
01)
Ornamental
0.023
(
lb
ai/
1000
ft2)
1
0.176
1087.0
468227.4
1084.4
Pome
Fruit
0.07
(
lb
ai/
1000
ft2)
1
0.07
357.1
153846.2
356.3
Nuts/
Stone
Fruit
0.12
(
lb
ai/
1000
ft2)
1
0.12
208.3
89743.6
207.9
Citrus
0.176
(
lb
ai/
1000
ft2)
1
0.023
142.0
61188.8
141.7
Average
Study
Use
Rate
0.0047
(
lb
ai/
gal,
17g
ai/
4
min
at
2GPM)
5
0.024
1063.8
458265.1
1061.4
6
Trees/
Ornamentals:
Hose
End
Sprayer
(
MRID
445185­
01)
Ornamental
0.023
(
lb
ai/
1000
ft2)
1
0.176
1560.8
1217391.3
1558.8
Pome
Fruit
0.07
(
lb
ai/
1000
ft2)
1
0.07
512.8
400000.0
512.2
Nuts/
Stone
Fruit
0.12
(
lb
ai/
1000
ft2)
1
0.12
299.1
233333.3
298.8
Citrus
0.176
(
lb
ai/
1000
ft2)
1
0.023
204.0
159090.9
203.7
Average
Study
Use
Rate
0.005
(
lb
ai/
gal
spray)
100
0.5
71.8
56000.0
71.7
TABLE
11
CARBARYL
NONCANCER
MOEs
ATTRIBUTABLE
TO
COMBINED
SHORT­
TERM
HOMEOWNER
HANDLER
DERMAL
AND
INHALATION
EXPOSURES
SCEN.
SCEN.
DESCRIPTOR
CROP
TYPE
OR
TARGET
EXPOSURE
FACTORS
DERMAL
MOEs
INHALATION
MOEs
COMBINED
MOEs
APPL.
RATE
(
lb
ai/
unit)
BASIS
FOR
RATE
(
defines
unit
treated)
TREATED
UNITS
ACTIVE
USED
(
lb
ai/
event)

55
7
Garden:
Backpack
Sprayer
(
PHED)
General
Use
(
2%
soln)
0.02
(
lb
ai/
gal
spray
applied)
5
0.1
2745.1
23333.3
2456.1
Perimeter
Nuisance
Pest
0.19
(
lb
ai/
1000
ft2)
1
0.19
1444.8
12280.7
1292.7
Vegetables
0.012
(
lb
ai/
1000
ft2)
1
0.012
22875.8
194444.4
20467.8
Vegetables/
Ornamentals
0.023
(
lb
ai/
1000
ft2)
1
0.023
11935.2
101449.3
10678.9
Vegetables
0.047
(
lb
ai/
1000
ft2)
1
0.047
5840.6
49645.4
5225.8
Average
Study
Use
Rate
0.083
(
lb
ai/
1000
ft2)
1
0.083
3307.3
28112.5
2959.2
Fire
Ant
0.0075
(
lb
ai/
gal
spray)
5
0.0375
7320.3
62222.2
6549.7
8
Lawn
Care:
Hose
End
Sprayer
(
MRID
449722­
01/
ORETF
OMA
004)
Lawn
(
broadcast)
0.25
(
lb
ai/
1000
ft2)
20
5
25.5
875.0
24.7
Lawn
(
spot)
0.25
(
lb
ai/
1000
ft2)
1
0.25
509.1
17500.0
494.7
9
Dusting
Dog
(
MRID
444399­
01)
Average
Study
Use
Rate
0.0026
(
lb
ai/
dog)
1
0.0026
163.2
1076.9
141.7
Dog
(
10%
&
½
of
2
lb)
0.1
(
lb
ai/
dog)
1
0.1
4.2
28.0
3.7
Dog
(
5%
&
½
of
2
lb)
0.05
(
lb
ai/
dog)
1
0.05
8.5
56.0
7.4
10
Dogs:
Liquid
Application
Dog
(
0.5%
&
½
of
6
oz)
0.001
(
lb
ai/
dog)
1
0.001
14000000.0
No
Data
No
Data
11
Granular
&
Baits
Lawn
Care:
Belly
Grinder
Lawn
(
spot)
0.21
(
lb
ai/
1000
ft2)
1
0.21
60.6
5376.3
59.9
Lawn
(
spot)
0.1
(
lb
ai/
1000
ft2)
1
0.1
127.3
11290.3
125.9
12
Granular
&
Baits
Lawn
Care:
Push­
Type
Spreader
(
MRID
449722­
01/
ORETF
OMA
003)
Lawn
(
broadcast)
0.21
(
lb
ai/
1000
ft2)
20
4.2
490.2
18315.0
477.4
Lawn
(
broadcast)
0.1
(
lb
ai/
1000
ft2)
20
2
1029.4
38461.5
1002.6
13
Granulars
&
Baits
By
Hand
Ornamentals
and
Gardens
0.21
(
lb
ai/
1000
ft2)
1
0.21
15.5
713.8
15.2
14
Aerosol
Various
0.005
(
0.5
%
ai
in
soln./
1
pt
can)
16
0.08
79.5
364.6
65.3
15
Collar
Dog
0.013
(
16
%
ai
per
1.3
oz
collar)
1
0.013
10769230.8
No
Data
No
Data
16
Sprinkler
Can
(
Source:
Scenario
6)
Ornamentals
(
2%
Soln)
0.02
(
2%
soln
used
ad
libitum)
5
0.1
359.0
280000.0
358.5
17
Ornamental
Paint
On
Ornamentals
(
2%
Soln)
0.02
(
2%
soln
used
ad
libitum)
1
0.02
304.3
12323.9
297.0
56
4.4.2.2
Residential
Handler
Cancer
Risks
Cancer
risks
were
calculated
by
comparing
the
Lifetime
Average
Daily
Dose
(
LADD)
to
the
Q1*
(
8.75
x
10­
4
(
mg/
kg/
day)­
1).
The
LADD
was
calculated
using
the
equation
below.

LADD
=
ADD
xTreatment
frequency
x
Working
duration
365
days/
year
Lifetime
Where:

LADD
=
Lifetime
Average
Daily
Dose
or
the
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
amortized
over
a
lifetime
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
ADD
=
Average
Daily
Dose
or
the
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
on
a
daily
basis
(
mg
pesticide
active
ingredient/
kg
body
weight/
day)
[
Note:
Represents
inhalation
and
dermal
exposure
contributions,
dermal
component
has
been
calculated
with
a
12.7
%
absorption
factor
defined
in
a
rat
study.];
Treatment
Frequency
=
The
annual
frequency
of
an
application
by
an
individual
(
days/
year);
Working
Duration
=
The
amount
of
a
lifetime
that
an
individual
spends
engaged
in
a
career
involving
pesticide
exposure
(
years);
Lifetime
=
The
average
life
expectancy
of
an
individual
(
years).

Cancer
risk
was
then
calculated
using
the
following
equation:

Risk
=
LADD
x
Q1*

Where:

Risk
=
Probability
of
excess
cancer
cases
over
a
lifetime
(
unitless);
Lifetime
Average
Daily
Dose
=
The
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
over
a
lifetime
(
mg
pesticide
active
ingredient/
kg
body
weight/
day,
also
referred
to
as
LADD);
and
Q1*
=
Quantitative
dose
response
factor
used
for
linear,
low­
dose
response
cancer
risk
calculations
(
mg/
kg/
day)­
1.

Table
12
presents
the
quantitative
risks
associated
with
each
scenario
considered
in
the
assessment.
For
all
but
one
scenario,
cancer
risks
are
less
than
1x10­
6
when
a
single
application
per
year
is
evaluated.
Risks
for
most
are
in
the
10­
8
or
10­
10
range.
However,
when
treating
dogs
with
½
bottle
of
10
percent
dust
the
risk
is
1.09x10­
6.
[
Note:
The
scenario
where
risks
are
still
of
concern
(
i.
e.,
>
1x10­
6)
is
highlighted
in
the
table.]
The
risk
associated
with
dusting
a
dog
should
also
be
taken
in
context
of
the
uncertainties
associated
with
cancer
risk
assessment.
In
effect,
this
value
is
1x10­
6.
This
table
also
includes
the
allowable
number
of
days
exposure
per
year.
There
are
5
scenarios
where
5
days
or
less
of
exposure
per
year
is
allowable.
These
results
should
be
considered
in
conjunction
with
the
use
and
usage
57
information
supplied
by
the
Bayer
that
indicates
the
60th
percentile
annual
frequency
of
use
is
between
1
and
2
uses
per
year
and
that
5
uses
per
year
is
at
the
84th
percentile.
As
with
the
noncancer
risks,
the
use
of
dusts
in
gardens
and
for
pet
grooming
along
with
some
liquid
sprays
on
ornamentals
appear
to
be
the
most
problematic
scenarios.
Cancer
risks
appear
to
be
less
of
concern
compared
to
noncancer
risks
for
all
corresponding
scenarios.

TABLE
12:
CARBARYL
CANCER
RISKS
ATTRIBUTABLE
TO
COMBINED
HOMEOWNER
HANDLER
DERMAL
AND
INHALATION
EXPOSURES
SCEN.
SCEN.
DESCRIPTOR
CROP
TYPE
OR
TARGET
EXPOSURE
FACTORS
CANCER
RISK
ALLOWED
DAYS/
YR
APPL.
RATE
(
lb
ai/
unit)
BASIS
FOR
RATE
(
defines
unit
treated)
TREATED
UNITS
ACTIVE
USED
(
lb
ai/
event)
1
Garden:
Ready­
to­
Use
Trigger
Sprayer
(
MRID
444598­
01)
Vegetables/
Ornamentals
0.003
32
oz
bottle
0.126
%
(
769­
977)
0.25
0.00075
1.27e­
10
>
365
Vegetables/
Ornamentals
0.003
32
oz
bottle
0.126
%
(
769­
977)
0.5
0.0015
2.54e­
10
>
365
Vegetables/
Ornamentals
0.003
32
oz
bottle
0.126
%
(
769­
977)
1
0.003
5.08e­
10
>
365
Average
Study
Use
Rate
0.012
(
lb
ai/
1000
ft2)
1
0.012
2.03e­
09
>
365
2
Garden/
Ornamental
Dust
(
MRID
444598­
01)
Vegetables/
Ornamentals
0.4
4
lb
bottle
10%
(
239­
1513)
0.25
0.1
4.81e­
08
21
Vegetables/
Ornamentals
0.4
4
lb
bottle
10%
(
239­
1513)
0.5
0.2
9.62e­
08
10
Vegetables/
Ornamentals
0.4
4
lb
bottle
10%
(
239­
1513)
1
0.4
1.92e­
07
5
Average
Study
Use
Rate
0.079
(
lb
ai/
1000
ft2)
1
0.079
3.80e­
08
26
3
Garden:
Hose­
End
(
MRID
444598­
01)
General
Use
(
2%
soln)
0.02
(
lb
ai/
gal
spray
applied)
100
2
2.11e­
07
5
Perimeter
Nuisance
Pest
0.19
(
lb
ai/
1000
ft2)
1
0.19
2.01e­
08
50
Vegetables
0.012
(
lb
ai/
1000
ft2)
1
0.012
1.27e­
09
>
365
Vegetables/
Ornamentals
0.023
(
lb
ai/
1000
ft2)
1
0.023
2.43e­
09
>
365
Vegetables
0.047
(
lb
ai/
1000
ft2)
1
0.047
4.97e­
09
201
Average
Study
Use
Rate
0.26
(
lb
ai/
1000
ft2)
1
0.26
2.75e­
08
36
Fire
Ant
0.0075
(
lb
ai/
gal
spray)
100
0.75
7.93e­
08
13
4
Garden:
Low
Pressure
Handwand
(
MRID
444598­
01)
General
Use
(
2%
soln)
0.02
(
lb
ai/
gal
spray
applied)
5
0.1
1.18e­
08
85
Perimeter
Nuisance
Pest
0.19
(
lb
ai/
1000
ft2)
1
0.19
2.25e­
08
45
Vegetables
0.012
(
lb
ai/
1000
ft2)
1
0.012
1.42e­
09
>
365
Vegetables/
Ornamentals
0.023
(
lb
ai/
1000
ft2)
1
0.023
2.72e­
09
>
365
Vegetables
0.047
(
lb
ai/
1000
ft2)
1
0.047
5.56e­
09
180
Average
Study
Use
Rate
0.083
(
lb
ai/
1000
ft2)
1
0.083
9.82e­
09
102
Fire
Ant
0.0075
(
lb
ai/
gal
spray)
5
0.0375
4.44e­
09
225
5
Trees/
Ornamentals:
Low
Pressure
Handwand
(
MRID
445185­
01)
Ornamental
0.023
(
lb
ai/
1000
ft2)
1
0.176
4.01e­
09
250
Pome
Fruit
0.07
(
lb
ai/
1000
ft2)
1
0.07
1.22e­
08
82
Nuts/
Stone
Fruit
0.12
(
lb
ai/
1000
ft2)
1
0.12
2.09e­
08
48
Citrus
0.176
(
lb
ai/
1000
ft2)
1
0.023
3.06e­
08
33
Average
Study
Use
Rate
0.0047
(
lb
ai/
gal,
17g
ai/
4
min
at
2GPM)
5
0.47
4.09e­
09
244
6
Trees/
Ornamentals:
Hose
End
Sprayer
(
MRID
445185­
01)
Ornamental
0.023
(
lb
ai/
1000
ft2)
1
0.176
2.79e­
09
359
Pome
Fruit
0.07
(
lb
ai/
1000
ft2)
1
0.07
8.49e­
09
118
Nuts/
Stone
Fruit
0.12
(
lb
ai/
1000
ft2)
1
0.12
1.45e­
08
69
Citrus
0.176
(
lb
ai/
1000
ft2)
1
0.023
2.13e­
08
47
Average
Study
Use
Rate
0.005
(
lb
ai/
gal
spray)
100
0.025
6.06e­
08
16
TABLE
12:
CARBARYL
CANCER
RISKS
ATTRIBUTABLE
TO
COMBINED
HOMEOWNER
HANDLER
DERMAL
AND
INHALATION
EXPOSURES
SCEN.
SCEN.
DESCRIPTOR
CROP
TYPE
OR
TARGET
EXPOSURE
FACTORS
CANCER
RISK
ALLOWED
DAYS/
YR
APPL.
RATE
(
lb
ai/
unit)
BASIS
FOR
RATE
(
defines
unit
treated)
TREATED
UNITS
ACTIVE
USED
(
lb
ai/
event)

58
7
Garden:
Backpack
Sprayer
(
PHED)
General
Use
(
2%
soln)
0.02
(
lb
ai/
gal
spray
applied)
5
0.1
1.66e­
09
>
365
Perimeter
Nuisance
Pest
0.19
(
lb
ai/
1000
ft2)
1
0.19
3.15e­
09
317
Vegetables
0.012
(
lb
ai/
1000
ft2)
1
0.012
1.99e­
10
>
365
Vegetables/
Ornamentals
0.023
(
lb
ai/
1000
ft2)
1
0.023
3.81e­
10
>
365
Vegetables
0.047
(
lb
ai/
1000
ft2)
1
0.047
7.79e­
10
>
365
Average
Study
Use
Rate
0.083
(
lb
ai/
1000
ft2)
1
0.083
1.38e­
09
>
365
Fire
Ant
0.0075
(
lb
ai/
gal
spray)
5
0.0375
6.22e­
10
>
365
8
Lawn
Care:
Hose
End
Sprayer
(
MRID
449722­
01/
ORETF
OMA
004)
Lawn
(
broadcast)
0.25
(
lb
ai/
1000
ft2)
20
5
1.73e­
07
6
Lawn
(
spot)
0.25
(
lb
ai/
1000
ft2)
1
0.25
8.64e­
09
116
9
Dusting
Dog
(
MRID
444399­
01)
Average
Study
Use
Rate
0.0026
(
lb
ai/
dog)
1
0.0026
2.82e­
08
35
Dog
(
10%
&
½
of
2
lb)
0.1
(
lb
ai/
dog)
1
0.1
1.09e­
06
1
Dog
(
5%
&
½
of
2
lb)
0.05
(
lb
ai/
dog)
1
0.05
5.43e­
07
2
10
Dogs:
Liquid
Application
Dog
(
0.5%
&
½
of
6
oz)
0.001
(
lb
ai/
dog)
1
0.001
3.11e­
13
>
365
11
Granular
&
Baits
Lawn
Care:
Belly
Grinder
Lawn
(
spot)
0.21
(
lb
ai/
1000
ft2)
1
0.21
7.21e­
08
14
Lawn
(
spot)
0.1
(
lb
ai/
1000
ft2)
1
0.1
3.43e­
08
29
12
Granular
&
Baits
Lawn
Care:
Push­
Type
Spreader
(
MRID
449722­
01/
ORETF
OMA
003)
Lawn
(
broadcast)
0.21
(
lb
ai/
1000
ft2)
20
4.2
8.97e­
09
112
Lawn
(
broadcast)
0.1
(
lb
ai/
1000
ft2)
20
2
4.27e­
09
234
13
Granulars
&
Baits
By
Hand
Ornamentals
and
Gardens
0.21
(
lb
ai/
1000
ft2)
1
0.21
2.83e­
07
4
14
Aerosol
Various
0.005
(
0.5
%
ai
in
soln./
1
pt
can)
16
0.08
5.94e­
08
17
15
Collar
Dog
0.013
(
16
%
ai
per
1.3
oz
collar)
1
0.013
4.04e­
13
>
365
16
Sprinkler
Can
(
Source:
Scenario
6)
Ornamentals
(
2%
Soln)
0.02
(
2%
soln
used
ad
libitum)
5
0.1
1.21e­
08
82
17
Ornamental
Paint
On
Ornamentals
(
2%
Soln)
0.02
(
2%
soln
used
ad
libitum)
1
0.02
1.44e­
08
69
4.4.3
Deterministic
Residential
Postapplication
Risk
Assessment
Carbaryl
uses
are
extremely
varied
and
include
home
gardens,
ornamentals,
turf
(
golf
courses
and
lawns)
and
companion
animals
(
e.
g.,
on
dogs
and
cats).
Carbaryl
also
has
more
limited
uses
that
were
considered
including
as
a
mosquito
adulticide
in
residential
areas
and
for
Ghost/
Mud
shrimp
control
in
Washington.
As
a
result,
a
wide
array
of
individuals
of
varying
ages
can
potentially
be
exposed
when
they
do
activities
in
areas
that
have
been
previously
treated
or
have
contact
with
treated
companion
animals.
The
residential
postapplication
risk
assessment
addresses
these
types
of
exposures.
59
The
risks
from
postapplication
exposure
to
carbaryl
residues
were
determined
for
the
following
populations:

1)
Residential
(
homeowner)
Adults:
The
following
postapplication
scenarios
were
assessed:
residential
turf
(
lawncare
and
after
mosquito
control),
swimming/
beach
activity
(
oyster
bed
treatments),
golfing
(
turfcare
and
after
mosquito
control),
home
garden
exposure
to
deciduous
trees
and
home
garden
exposure
to
fruiting
vegetables.
Within
each
scenario,
ranges
of
exposure
were
evaluated
for
different
application
rates,
duration
of
exposure,
and
postapplication
activities
(
e.
g.,
weeding,
harvesting).

2)
Toddlers
(
3
year­
olds):
Toddlers
were
selected
as
a
representative
population
for
turf
and
companion
animal
assessments.
Exposures
from
turf
were
evaluated
separately
for
lawncare
uses
and
after
mosquito
control.
Beach
activity
(
oyster
bed
treatments)
was
also
evaluated.
Separate
risk
assessments
were
considered
individually
and
as
a
total
exposure
for
turf
­
dermal
exposure
and
hand­
to­
mouth,
object­
to­
mouth
and
soil
ingestion.
For
pet
uses
and
the
beach
play
assessments,
dermal
and
hand­
to­
mouth
exposures
were
considered
individually
and
as
a
total
exposure.
A
separate
assessment
was
also
done
for
toddlers
who
could
potentially
ingest
carbaryl
granules
in
an
episodic
fashion.
[
Note:
Values
for
this
population
were
used
in
the
aggregate
risk
calculations
for
children
(
1
to
6
years
old).]

3)
Youth­
aged
children
(
ages
10
to
12):
children
of
this
age
could
help
with
garden
maintenance
(
deciduous
trees
and
fruiting
vegetables)
and
therefore
were
considered
for
activities
related
to
fruiting
vegetables
and
fruit
trees.

Data
and
Assumptions
A
series
of
data,
assumptions,
and
exposure
factors
served
as
the
basis
for
completing
the
residential
handler
risk
assessments,
as
described
below.
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
and
related
documents).

°
Several
carbaryl­
specific
studies
were
used
in
the
development
of
this
assessment
including
a
turf
transferable
residue
(
TTR)
study
conducted
in
California,
Georgia,
and
Pennsylvania
at
8.17
lb
ai/
acre
(
MRID
451143­
01).
This
study
was
conducted
using
the
standard
ORETF
protocol.
The
Georgia
data
were
used
for
the
assessment
(
all
were
similar).
Residue
transferability
observed
in
this
data
was
1.20
percent.
The
Agricultural
Reentry
Task
Force
(
ARTF)
conducted
several
dislodgeable
foliar
residue
(
DFR)
studies
with
carbaryl.
The
olive
pruning
(
MRID
451751­
02)
and
cabbage
weeding
(
MRID
451917­
01)
studies
were
used
in
the
home
garden
risk
assessments.
Bayer
is
a
member
of
the
ARTF
so
there
are
no
data
compensation
issues
associated
with
the
use
of
these
data.
All
of
these
carbaryl­
specific
studies
should
be
considered
high
quality
for
risk
assessment
purposes.
A
study
was
also
submitted
by
Wellmark
(
MRID
45792201)
which
quantified
transferable
residues
from
dogs
wearing
carbaryl­
containing
collars
which
were
used
for
the
pet
risk
assessment.
This
study
was
of
marginal
quality
but
it
did
provide
product­
specific
information
and
was
used
in
conjunction
with
standard
Agency
approaches
for
comparative
purposes.
60
°
Two
other
studies
completed
by
the
Washington
State
Department
of
Ecology
were
used
for
completing
the
risk
assessment
for
the
oyster
bed
use.
These
studies
provided
water
and
sediment
concentration
data
in
Willapa
Bay
where
these
applications
occur.

°
Exposure
frequency
values
used
in
cancer
risk
assessments
for
adults
are
the
same
as
those
used
for
residential
handlers
(
1
time
per
year).
However,
the
Agency
does
believe
that
there
are
higher
frequency
golfers
(
i.
e.,
average
golfers
over
all
ages
play
18
rounds
year)
based
on
a
1992
report
(
Golf
Course
Operations,
Cost
of
Doing
Business/
Profitability
by
the
Center
For
Golf
Course
Management).
The
number
of
exposure
days
per
year
has
also
been
calculated
for
all
postapplication
exposure
scenarios.

°
Several
models
and
published
data
sources
were
also
used
to
develop
the
risk
assessment.
These
include
papers
related
to:
deposition
from
mosquito
control
by
Dukes
et
al
from
Florida
A&
M
University
and
transference
of
residues
from
treated
pets
by
Boone
et
al
from
Mississippi
State
University.
The
Agency's
Standard
Operating
Procedures
For
Residential
Exposure
Assessment
were
the
primary
guidance
used
for
this
assessment.
Several
other
models
and
guidance
documents
were
also
used
including
the
Agency's
SWIMODEL
(
for
swimmers
in
Willapa
Bay
after
oyster
bed
treatments);
AgDrift
V2.0
(
for
risks
from
mosquito
control),
and
the
Risk
Assessment
Guidance
For
Superfund
or
RAGS
(
for
dermal
exposures
during
beach
play
and
oyster
harvest).
Specific
information
from
the
mosquito
control
label
and
historical
information
for
oyster
bed
applications
were
also
used
to
complete
the
assessments
(
e.
g.,
droplet
spectra
requirements
to
predict
deposition
from
aerial
treatments
during
mosquito
control).

°
The
Agency
calculates
total
exposures
to
individual
chemicals
when
it
is
likely
that
behaviors
could
occur
simultaneously
that
would
lead
to
the
overall
dose
for
the
exposed
population
of
concern.
The
Agency
has
added
together
risk
values
(
i.
e.,
MOEs)
for
different
kinds
of
exposures
within
the
turf
(
dermal,
hand­
to­
mouth,
object­
to­
mouth,
and
soil
ingestion)
and
pet
scenarios
(
dermal
and
hand­
to­
mouth).
These
represent
the
standard
set
of
exposures
that
are
typically
added
together
when
chemicals
are
used
on
turf
or
on
pets
because
it
is
logical
they
can
co­
occur.

°
Exposures
to
children
playing
on
treated
turf
as
well
as
adults
on
turf
(
lawncare
and
golfing)
have
been
addressed
using
the
latest
Agency
approaches
for
this
scenario
including:
°
5
percent
of
the
application
rate
has
been
used
to
calculate
the
0­
day
residue
levels
used
for
defining
risks
from
hand­
to­
mouth
behaviors,
measured
TTR
values
are
not
used
because
of
differences
in
transferability
versus
what
would
be
expected
during
hand­
tomouth
behaviors;
°
20
percent
of
the
application
rate
has
been
used
to
calculate
the
0­
day
residue
levels
used
for
defining
risks
from
object­
to­
mouth
behaviors,
measured
TTR
values
are
not
used
because
of
differences
in
transferability
versus
what
would
be
expected
during
hand­
tomouth
behaviors,
a
higher
percent
transfer
has
been
used
for
object­
to­
mouth
behaviors
because
it
involves
a
teething
action
believed
to
be
more
analogous
to
DFR/
leaf
wash
sample
collection
where
20
percent
is
also
used;
61
°
the
measured
TTR
levels
quantified
in
MRID
451143­
01
have
been
used
to
complete
the
dermal
exposure
calculations
as
the
0­
day
transferability
was
>
1
percent
of
the
application
rate
for
the
short­
and
intermediate­
term
data
sources,
studies
where
transferability
is
less
than
1
percent
are
not
used
for
risk
assessment
purposes
because
the
transfer
coefficients
used
by
the
Agency
for
defining
exposures
are
based
on
Jazzercize
studies
in
which
TTR
values
were
measured
by
techniques
where
transferability
is
generally
in
the
1
to
5
percent
range
other
than
the
ORETF
roller
method
where
transferability
tends
to
be
lower;
°
short­
and
intermediate­
term
exposures
have
been
calculated
because
play
and
mouthing
behaviors
are
assumed
to
routinely
occur
daily
and
for
extended
periods
such
as
over
30
days,
carbaryl
residues
are
also
expected
to
be
present
based
on
residue
dissipation
data
(
i.
e.,
slow
dissipation
rate);
°
in
cases
where
0
day
residues
have
been
calculated
based
on
application
rates
(
i.
e.,
hand­
/
object­
to­
mouth
residues
and
for
soil
dissipation),
dissipation
over
time
measured
in
the
TTR
study
(
i.
e.,
slope
of
decay
curve)
has
been
used
to
predict
TTR
and
soil
levels
over
time,
carbaryl
residues
were
detectable
even
at
14
days
after
application
(
i.
e.,
final
sampling
interval)
at
all
sites
in
the
TTR
studies
used
in
this
assessment,
at
14
days
average
residues
at
the
Georgia
and
Pennsylvania
study
sites
were
still
orders
of
magnitude
above
the
quantitation
limit,
this
indicates
that
predicted
residue
levels
for
extended
durations
should
be
considered
appropriate
based
on
the
empirical
data
(
e.
g.,
critical
for
consideration
of
intermediate­
term
exposures);
°
the
transfer
coefficients
used,
except
golfing,
are
those
presented
at
the
1999
Agency
presentation
before
the
FIFRA
Science
Advisory
Panel
that
have
been
adopted
in
routine
practice
by
the
Agency;
°
transfer
coefficients
have
been
adjusted
for
differences
between
short­
and
intermediateterm
exposures;
°
adult
golfers
have
been
assessed
using
a
transfer
coefficient
of
500
cm2/
hour
[
Note:
The
Agency
is
currently
developing
a
policy
on
golfer
exposures
and
has
used
this
value
in
other
assessments];
°
3
year
old
toddlers
are
expected
to
weigh
15
kg;
°
hand­
to­
mouth
exposures
are
based
on
a
frequency
of
20
events/
hour
and
a
surface
area
per
event
of
20
cm2
representing
the
palmar
surfaces
of
three
fingers;
°
saliva
extraction
efficiency
is
50
percent
meaning
that
every
time
the
hand
goes
in
the
mouth
approximately
½
of
the
residues
on
the
hand
are
removed;
°
object­
to­
mouth
exposures
are
based
on
a
25
cm2
surface
area;
°
exposure
durations
are
expected
to
be
2
hours
based
on
information
in
the
Agency's
Exposure
Factors
Handbook
except
for
golfers
where
the
exposure
duration
for
an
18
hole
round
of
golf
is
4
hours
based
on
a
1992
report
(
Golf
Course
Operations,
Cost
of
Doing
Business/
Profitability
by
the
Center
For
Golf
Course
Management);
°
soil
residues
are
contained
in
the
top
centimeter
and
soil
density
is
0.67
mL/
gram;
°
dermal,
hand­
and
object­
to­
mouth,
and
soil
ingestion
are
added
together
to
represent
an
overall
risk
from
exposure
to
turf
while
granular
ingestion
is
considered
to
be
a
much
more
episodic
behavior
and
is
considered
separately
by
the
Agency;
62
°
children
of
various
ages
down
to
the
very
young
(
e.
g.,
4
or
5
years
old)
are
currently
playing
golf,
the
Agency
recognizes
that
age
may
impact
exposures
because
of
changes
in
behavior
and
skin
surface
area
to
body
weight
ratios
but
has
not
yet
developed
a
quantitative
approach
for
calculating
their
risks;
and
°
comments
were
received
on
the
previous
version
of
the
assessment
(
D281418,
5/
29/
02)
that
indicated
a
concern
because
the
Agency
did
not
consider
"
feral"
food
intake,
the
Agency
position
is
that
the
hand­
to­
mouth
and
object­
to­
mouth
assessments
included
for
children
playing
on
turf
would
address
this
issue
particularly
since
the
object­
to­
mouth
scenario
is
based
on
a
child
mouthing
treated
turf.

°
Exposures
to
children
and
adults
working
in
home
gardens
have
been
addressed
using
the
latest
Agency
approaches
for
this
scenario
including:
°
youth­
aged
children
are
considered
along
with
adults;
°
12
year
old
youth
are
expected
to
weigh
39.1
kg;
°
exposure
durations
are
expected
to
be
40
minutes;
°
Pre­
Harvest
Intervals
(
PHIs)
are
less
than
7
days
for
most
crops
with
some
as
long
as
28
days;
°
transfer
coefficients
for
youth
were
calculated
by
adjusting
the
appropriate
adult
transfer
coefficients
by
a
50%
factor
as
has
been
done
by
the
Agency
since
the
inception
of
the
SOPs
For
Residential
Exposure
Assessment;
°
the
updated
transfer
coefficients
specified
in
Agency
policy
003
described
above
in
the
occupational
risk
assessment
for
fruit
tree
thinners
and
harvesters
have
been
used
rather
than
those
currently
specified
in
the
SOPs
because
they
represent
more
refined
estimates
of
exposure
for
the
fruiting
vegetable
and
deciduous
tree
crop
groups,
these
crop
groups
have
been
used
in
the
SOPs
to
represent
home
garden
exposures;
°
the
combination
of
adjusting
transfer
coefficients
for
youth­
aged
children
and
using
appropriate
body
weights
for
the
age
group
results
in
dose
levels
that
are
slightly
lower
than
that
of
adults
in
the
same
activity
(
the
TC
reduction
and
body
weight
reduction
is
essentially
a
1:
1
ratio);
and
°
the
DFR
data
used
for
the
assessments
are
the
same
as
those
used
in
the
occupational
risk
assessment
for
the
selected
crop
groups.

C
Exposures
to
children
after
contact
with
treated
pets
have
been
addressed
using
the
latest
Agency
approaches
for
this
scenario
including:
°
only
toddlers
are
considered
because
their
exposures
are
thought
to
be
highest
exposed
population
(
i.
e.,
they
are
considered
the
sentinel
population
by
the
Agency);
°
a
equilibrium
approach
based
on
a
single
child
"
hug"
of
the
treated
animal
is
used
to
assess
dermal
exposure
as
described
in
the
1999
Agency
SAP
Overview
document
(
i.
e.,
the
skin
loads
after
a
single
contact
with
the
treated
animal
and
additional
contacts
don't
proportionally
add
exposures),
the
surface
area
of
the
dermal
hug
is
based
on
a
toddler
skin
surface
area
and
typical
clothing;
°
residue
dissipation
is
5
percent
per
day
for
the
shampoo
and
dust
products
(
based
on
data
from
J.
Chambers
at
Mississippi
State
University
on
other
pet
use
products);
63
°
the
Agency
default
for
transferability
of
residues
from
fur
is
20
percent,
however,
a
pet
collar
transferable
residue
study
(
MRID
45792201)
was
submitted
and
used
in
the
assessment
for
comparative
purposes
with
the
Agency's
standard
approach,
the
data
from
this
study
were
used
to
develop
an
alternative
transferability
factor
of
2.6
percent
for
dusts
and
liquid
applications
(
even
though
the
physical
forms
are
very
different
which
should
be
considered);
°
the
active
lifetime
of
a
collar
is
expected
to
be
120
days
based
on
label
statements
which
was
used
by
the
Agency,
a
daily
emission
term
from
the
collar
of
0.000290
mg/
cm2/
gram
ai/
day
is
also
based
on
measured
data
from
Mississippi
State
University
for
a
pet
collar,
additionally
data
from
a
pet
collar
transferable
residue
study
(
MRID
45792201)
was
submitted
and
used
in
the
assessment
for
comparative
purposes
with
the
Agency's
standard
approach
the
data
from
this
study
were
used
to
complete
risk
calculations
using
direct
measurements
of
transferable
residue
concentration
on
dogs;
°
risks
are
based
on
an
even
loading
of
residues
across
the
entire
surface
of
a
30
lb
dog
which
has
been
chosen
as
a
representative
animal,
the
animal
surface
area
was
calculated
using
(
12.3
*
Body
Weight
(
g)
0.65)
from
the
Agency's
1993
Wildlife
Exposure
Factors
Handbook
(
i.
e.,
dog
surface
area
of
5986
cm2);
°
the
approach
used
to
address
the
hand­
to­
mouth
exposure
pathway
has
been
modified
since
the
previous
risk
assessment,
in
previous
assessment
contact
with
dogs
was
based
on
40
events
per
day,
in
each
event,
the
palmar
surface
of
the
hands
(
i.
e.,
20cm2/
event)
is
placed
in
the
mouth
of
the
child
contributing
to
nondietary
ingestion
exposure,
in
the
revised
approach
the
frequency
term
has
been
modified
to
an
equilibrium
approach
analogous
to
the
dermal
"
hug"
exposure
component
(
i.
e.,
the
frequency
=
1)
because
the
data
on
which
the
transferable
residue
concentrations
are
based
rely
on
a
5
minute
heavy
rubbing/
petting
technique
that
would
lead
to
concentrations
on
the
hands
that
would
be
expected
to
be
significantly
higher
than
would
result
from
a
single
contact.

4.4.3.1
Deterministic
Residential
Postapplication
Exposure
and
Noncancer
Risks
Two
different
types
of
noncancer
risk
calculations
were
required
based
on
expected
exposure
durations,
i.
e.,
short­
term
(#
30
days)
and
intermediate­
term
(
30
days
up
to
several
months).
Intermediate­
term
risks
were
calculated
in
a
postapplication
situation,
when
they
were
not
for
residential
handlers,
because
residue
dissipation
data
demonstrated
that
carbaryl
residues
persist
over
that
time
and
it
is
clear
that
the
behaviors
considered
as
the
basis
for
this
assessment
can
occur
routinely
over
extended
periods
of
time
thus
creating
a
potential
window
for
those
exposures
(
e.
g.,
children
playing
outside
on
the
grass
is
expected
to
be
a
routine
activity).
Noncancer
risks
were
calculated
using
the
MOE
approach,
as
described
under
Section
4.4.2.
The
toxicological
endpoint
of
concern
and
target
MOE
for
short­
term
and
intermediate­
term
dermal
exposures
is
the
same
as
that
used
for
the
short­
term
dermal
exposure
for
residential
handlers
(
i.
e.,
NOAEL
of
20
mg/
kg
from
the
21­
day
dermal
toxicity
study
in
the
rat
and
a
target
MOE
of
100).
The
endpoints
of
concern
and
target
MOE
for
short­
term
and
intermediate­
term
nondietary
ingestion
exposure
were
defined
in
the
rat
developmental
neurotoxicity
study
and
subchronic
neurotoxicity
studies,
respectively
(
i.
e.,
NOAEL
of
1
mg/
kg/
day
defined
in
both
studies
with
a
target
MOE
of
100).
64
Several
different
types
of
calculations
were
used
in
this
assessment
to
reflect
the
varying
age
groups,
behaviors,
data,
and
activities
that
were
considered.
In
essence,
all
can
be
summarized
by
saying
that
a
source
of
some
sort
(
e.
g.,
DFR
on
leaves)
comes
in
contact
with
a
person
as
they
are
doing
an
activity
(
e.
g.,
harvesting
garden
plants).
Exposures
were
then
calculated
by
multiplying
the
source
concentration
by
some
factor
(
e.
g.,
transfer
coefficient
for
fruit
harvesting)
and
the
duration.
All
of
the
calculations
are
explained
in
detail
in
the
Occupational
and
Residential
Exposure
Chapter
(
D287251).
Two
of
the
key
algorithms
are
presented
below
for
informational
purposes.
These
represent
the
predominant
types
of
exposures
considered
in
the
postapplication
assessment
(
i.
e.,
dermal
and
hand­
tomouth

Dermal
exposures
were
calculated
by
considering
the
potential
sources
of
exposure
in
the
environment,
which
represent
the
DFRs
on
garden
plants,
TTRs
on
lawns,
and
transferable
residues
on
treated
pets
using
the
following
equation.
It
should
also
be
noted
that
there
are
distinct
transfer
coefficients
for
different
activities
(
e.
g.,
fruit
harvest
versus
lawncare).

DE(
t)
(
mg/
day)
=
(
TR(
t)
(
µ
g/
cm2)
x
TC
(
cm2/
hr)
x
Hr/
Day)/
1000
(
µ
g/
mg)

Where:

DE(
t)
=
Daily
exposure
or
amount
deposited
on
the
surface
of
the
skin
at
time
(
t)
attributable
for
activity
in
a
previously
treated
area,
also
referred
to
as
potential
dose
(
mg
ai/
day);
TR(
t)
=
Transferable
residues
that
can
either
be
dislodgeable
foliar
or
turf/
pet
transferable
residues
at
time
(
t)
where
the
longest
duration
is
dictated
by
the
decay
time
observed
in
the
studies
(
µ
g/
cm2);
TC
=
Transfer
Coefficient
(
cm2/
hour);
and
Hr/
day
=
Exposure
duration
meant
to
represent
a
typical
workday
(
hours).

[
Note:
For
pets,
the
TC
and
Hr/
day
terms
are
replaced
with
a
onetime
"
hug"
scenario.]

Likewise,
nondietary
ingestion
from
hand­
to­
mouth
behaviors
also
consider
the
environmental
concentrations
and
the
mouthing
behaviors
of
children.
The
following
equation
describes
how
these
exposures
have
been
calculated.

Where:
D
=
dose
from
hand­
to­
mouth
activity
(
mg/
day);
TR
=
Transferable
residues
that
can
either
be
dislodgeable
foliar
or
turf/
pet
transferable
residues
at
time
(
t)
where
the
longest
duration
is
dictated
by
the
decay
time
observed
in
the
studies
(
µ
g/
cm2);
SE
=
saliva
extraction
factor
(%);
6
Maximum
rates
of
4
to
8
lb
ai/
acre
are
specified
for
different
pests.
There
is
one
carbaryl
label
with
a
turf
application
rate
of
11
lb
ai/
acre;
however,
based
on
the
information
from
the
registrant
at
the
SMART
meeting
and
the
TTR
study
(
MRID
45334301),
the
maximum
rate
is
more
likely
to
be
8
lb
ai/
acre.
In
addition,
risks
exceed
HED's
level
of
concern
at
8
lbs
ai/
acre.

65
SA
=
surface
area
of
the
hands
(
cm2);
Freq
=
frequency
of
hand­
to­
mouth
events
(
events/
hour);
and
Hr
=
exposure
duration
(
hours).

[
Note:
For
pets,
the
SA
and
frequency
terms
are
replaced
with
a
onetime
"
hug"
scenario.]

The
(
TR(
t))
input
may
represent
levels
on
a
single
day
after
application
in
the
case
of
short­
term
risk
calculations.
For
intermediate­
term
calculations,
30­
day
average
concentrations
were
calculated
based
on
the
applicability
of
the
toxicology
data
(
i.
e.,
intermediate­
term
endpoint
is
applied
to
exposures
>
30
days).
For
the
mosquito
control
scenarios
the
method
used
in
the
calculation
was
similar
to
that
used
in
the
turf
assessment
except
that
an
additional
factor
was
incorporated
to
account
for
the
amount
that
deposits
on
grass
in
treated
areas.
The
oyster
bed
analyses
were
completed
using
RAGS
where
dose
is
based
on
skin
loading
which
is
then
absorbed.
Exposures
for
swimmers
were
calculated
using
the
Agency's
SWIMODEL.

Adult
Short­
term
MOEs
only
for
lawncare
(
i.
e.,
heavy
yardwork)
exceed
the
Agency's
level
of
concern
on
the
day
of
application
(
i.
e.,
43
to
88).
For
this
activity,
it
takes
1
and
5
days,
respectively
at
the
4
and
8
lb
ai/
acre
application
rates,
6
for
residues
to
dissipate
to
a
point
where
short­
term
MOEs
are
$
100.
In
all
other
scenarios
considered,
short­
term
MOEs
are
$
100
on
the
day
of
application.
These
other
scenarios
include
vegetable
gardening,
golfing,
tending
fruit
trees,
and
more
localized
exposures
that
occur
after
mosquito
control
or
oyster
bed
treatments.
Intermediate­
term
MOEs
were
calculated
using
30
day
average
exposures
and
the
dissipation
rate
for
carbaryl.
In
all
cases,
intermediate­
term
MOEs
are
$
100.
Table
13
presents
the
postapplication
MOE
values
calculated
for
adults
after
lawn
and
home
garden
applications
of
carbaryl.

Table
13:
Summary
of
Carbaryl
Noncancer
Postapplication
Residential
MOEs
For
Adults
Scenario
Descriptor
Results
Short­
term
MOE
on
Day
0
Days
Short­
term
MOE$
UF
Intermediate­
term
MOE
Residential
Turf
(
Lawncare)
Max
Rate
at
4
lb
ai/
A
88
1
842
Max
Rate
at
8
lb
ai/
A
43
5
412
Aerial
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
3700­
231268
(
1738
w/
inhalation
at
1
lb
ai/
acre)
0
35463­
2216454
Ground
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
7031­
439409
0
67380­
4211262
Golfing
Max
Rate
at
4
lb
ai/
A
1274
0
12297
Table
13:
Summary
of
Carbaryl
Noncancer
Postapplication
Residential
MOEs
For
Adults
Scenario
Descriptor
Results
Short­
term
MOE
on
Day
0
Days
Short­
term
MOE$
UF
Intermediate­
term
MOE
66
Max
Rate
at
8
lb
ai/
A
624
0
6021
Aerial
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
53654­
3353387
0
517764­
32360224
Ground
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
101943­
6371435
0
983751­
61484426
Home
Garden
(
Deciduous
Tree)
Very
Low
Exposure
(
propping)
17373
0
53139
Low
Exposure
(
irrigation,
scout,
weed)
1737
0
5314
High
Exposure
(
harvest,
prune,
train,
tie)
1158
0
3543
Very
High
Exposure
(
thin)
579
0
1771
Home
Garden
(
Fruiting
Vegetable)
Low
Exposure
(
irrigation,
scout,
thin,
weed)
1758
0
9468
Medium
Exposure
(
irrigation,
scout)
1256
0
6763
High
Exposure
(
harvest,
prune,
stake,
tie)
879
0
4734
Oyster
Beds
Oyster
Harvest
967137
0
2680745
Swimming
293651
0
No
Data
Inhalation
MOE
for
adult
mosquito
control
calculated
using
a
ground
concentration
of
40
ng/
L
calculated
with
AgDrift,
a
respiration
rate
for
light
activity,
and
a
20
minute
duration
to
allow
for
dissipation
of
the
spray.
The
MOE
for
inhalation
is
3279.

Youth­
aged
children
(
10
to
12
years
old)
were
only
considered
in
the
home
garden
scenarios
per
Agency
guidance.
Short­
term
MOEs
for
these
children
were
similar
to
those
calculated
for
adults
in
that
they
were
$
100
for
all
of
the
gardening
scenarios
considered
on
the
day
of
application.
Intermediate­
term
MOEs
were
calculated
using
30
day
average
exposures
and
the
dissipation
rate
for
carbaryl.
In
all
cases,
intermediate­
term
MOEs
are
$
100.
Table
14
below
summarizes
the
postapplication
MOE
values
calculated
for
youth
home
garden
applications
of
carbaryl.
67
Table
14:
Summary
of
Carbaryl
Noncancer
Postapplication
Residential
MOEs
For
Youth­
Aged
Children
Scenario
Descriptor
Results
Short­
term
MOE
on
Day
0
Days
Short­
term
MOE$
UF
Intermediate­
term
MOE
Home
Garden
(
Deciduous
Tree)
Very
Low
Exposure
(
propping)
19408
0
59364
Low
Exposure
(
irrigation,
scout,
weed)
1941
0
5936
High
Exposure
(
harvest,
prune,
train,
tie)
1294
0
3958
Very
High
Exposure
(
thin)
647
0
1979
Home
Garden
(
Fruiting
Vegetable)
Low
Exposure
(
irrigation,
scout,
thin,
weed)
1964
0
10577
Medium
Exposure
(
irrigation,
scout)
1403
0
7555
High
Exposure
(
harvest,
prune,
stake,
tie)
982
0
5289
Toddler
(
3
year
old)
exposures
were
considered
for
a
variety
of
scenarios
as
described
above
including
play
on
treated
turf,
play
with
treated
pets,
after
mosquito
control,
and
after
oyster
bed
treatments.
Ingestion
of
granules,
which
is
considered
a
highly
episodic
event
by
the
Agency
is
also
described
below.
The
results
from
all
scenarios
considered
are
presented
below
in
Table
15.

Short­
term
MOEs
from
exposure
to
treated
turf
(
in
products
labeled
for
direct
application
to
turf)
were
<
100
on
the
day
of
application
for
both
rates
considered
(
i.
e.,
4
and
8
lb
ai/
acre).
In
fact,
short­
term
MOEs
from
individual
pathways
were
not
$
100
for
any
turf
scenario
considered
on
the
day
of
application
except
for
the
soil
ingestion
component
of
the
turf
assessment
which
is
a
very
minor
contributor
to
overall
exposures.
As
a
reminder,
dermal,
hand­
to­
mouth,
and
object­
to­
mouth
exposures
pathways
were
considered
along
with
soil
ingestion.
Total
short­
term
MOEs
(
all
pathways)
were
$
100
at
the
lower
4
lb
ai/
acre
application
rate
14
days
after
application
and
18
days
at
the
higher
8
lb
ai/
acre
application
rate.
Dermal
and
hand­
to­
mouth
exposures
were
the
key
contributors
while
soil
ingestion
was
a
minor
contributor
to
the
total
MOE
estimates.
Intermediate­
term
MOEs
were
calculated
using
30
day
average
exposures
and
the
dissipation
rate
for
carbaryl.
For
both
rates,
intermediate­
term
MOEs
were
<
100.
Exposures
to
toddlers
were
also
considered
after
application
of
carbaryl
as
a
mosquito
adulticide.
The
risks
are
presented
along
with
the
turf
use
risks
because
the
methods
are
similar
except
that
mosquito
control
calculations
also
account
for
deposition
from
aerial
and
ground
foggers.
Regardless
of
how
applications
are
made
(
i.
e.,
by
ground
or
air),
both
short­
term
MOEs
on
the
day
of
application
and
intermediate­
term
MOEs
were
$
100.
An
inhalation
component
was
also
included
for
mosquito
control
on
the
day
of
application
(
MOE
was
well
above
100).
68
The
assessments
for
pet
uses
considered
dermal
and
nondietary
ingestion
exposures
and
also
calculated
total
MOEs.
Short­
term
MOEs
for
pet
uses
using
the
Agency's
current
approach
were
<
100
even
30
days
after
application
regardless
of
whether
the
formulation
used
was
a
dust,
liquid
or
collar.
Hand­
to­
mouth
and
dermal
exposures
are
approximately
equal
contributors
to
the
overall
estimates
for
each
product
type.
The
results
are
similar
for
the
intermediate­
term
MOEs
for
each
scenario.
There
is
one
pet
use
which
is
also
considered
to
be
a
chronic
exposure
by
the
Agency.
Pet
collars
are
assumed
to
be
worn
all
of
the
time
so
chronic
exposure
can
potentially
occur.
The
chronic
MOE
for
pet
collars
mirrors
the
short­
and
intermediate­
term
results.
The
Agency
also
utilized
the
results
of
the
submitted
study
for
comparative
rangefinder
purposes
that
quantified
transferable
residues
from
carbaryl
collars.
[
Note:
The
Agency
anticipates
because
of
the
slow
collar
release
that
corresponding
transferable
residues
for
collars
would
be
lower
than
for
other
products.]
The
Agency
has
concerns
over
the
lack
of
quality
control
data
in
this
study
but
opted
to
provide
risk
estimates
based
on
it
for
comparison
because
it
is
chemical­
specific.
A
transferability
factor
of
2.6
percent,
instead
of
the
Agency's
standard
20
percent,
was
developed
from
this
study
then
used
to
complete
assessments
for
dusts
and
liquid
products
Even
using
the
2.6
percent
factor,
MOEs
for
dusts
and
liquid
products
were
well
<
100
on
the
day
of
application.
However,
the
intermediate­
term
MOE
for
liquids
was
>
100
using
this
factor.
Direct
transferable
residue
concentrations
from
the
study
were
also
used
to
calculate
risks
for
collars.
Using
these
concentrations,
MOEs
exceeded
Agency
targets
by
a
small
margin.
The
Agency
has
concerns
for
the
use
of
dust
and
liquid
products
on
pets
given
that
the
risks
associated
with
dusts
and
liquids,
regardless
of
whether
or
not
the
collar
study
data
were
used
in
the
assessment,
did
not
exceed
Agency
targets
(
i.
e.,
MOEs<
100).
The
Agency
believes
that
the
use
of
the
transferable
residue
concentrations
from
the
collar
study
is
reasonable
to
use
for
the
collar
assessment.
However,
because
of
the
marginal
quality
of
the
study
the
Agency
believes
confirmatory
data
are
needed
because
MOEs
using
these
data
are
marginally
above
100.
The
study
cannot
also
be
considered
for
use
in
any
chronic
assessment
since
it
measured
residue
concentrations
only
out
to
7
days
after
placement
of
the
collars.

The
assessments
for
beach
play
for
toddlers
after
oyster
bed
treatment
considered
dermal
and
nondietary
ingestion
exposures
and
also
calculated
total
MOEs.
Short­
term
MOEs
were
>
100
even
if
the
highest
monitored
sediment
concentration
value
from
any
study
available
to
the
Agency
was
used
as
the
basis
for
the
calculations.
The
intermediate­
term
results
were
similar.
69
Table
15:
Summary
of
Carbaryl
Noncancer
Postapplication
Residential
Aggregate
MOEs
For
Toddlers
Scenario
Descriptor
Results
Short­
term
MOE
on
Day
0
Days
For
Short­
term
MOE$
UF
Intermediateterm
MOE
Chronic
MOE
Pet
Treatments
Liquids
(
Agency
approach)
9.5
+
30
18.6
NA
Dusts
(
Agency
approach)
0.10
+
30
0.19
NA
Collars
(
Agency
approach)
84.5
+
30
84.5
110
(
need
300)

Liquids
(
2.6%
transferability
based
on
collars)
73.2
7
143
NA
Dusts
(
2.6%
transferability
based
on
collars)
0.73
+
30
1.43
NA
Collars
(
measured
transferable
residues
over
whole
dog
)
346
364
at
1
week
NA
(
only
7
day
monitoring)
NA
(
only
7
day
monitoring)

Residential
Turf
Max
Rate
at
4
lb
ai/
A
11
14
91
NA
Max
Rate
at
8
lb
ai/
A
5
18
45
NA
Aerial
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
448­
27983
(
350
w/
inhalation
at
1
lb
ai/
acre)
0
3826­
239095
NA
Ground
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
851­
53167
0
7269­
454280
NA
Oyster
Beds
Beach
Play
29532
0
81859
NA
Inhalation
MOE
for
children
mosquito
control
calculated
using
a
ground
concentration
of
40
ng/
L
calculated
with
AgDrift,
a
respiration
rate
for
light
activity,
and
a
20
minute
duration
to
allow
for
dissipation
of
the
spray.
The
MOE
for
inhalation
is
1609.

Ingestion
of
carbaryl
granules
is
also
a
potential
source
of
exposure
because
children
can
eat
them
if
they
are
found
in
treated
lawns
or
gardens.
This
scenario
is
considered
to
be
an
episodic
in
nature.
Therefore,
acute
dietary
endpoints
are
always
used.
The
concentration
of
carbaryl
in
granular
products
ranges
generally
from
2
to
10
percent.
If
this
information
is
coupled
with
the
body
weight
of
a
toddler
(
15
kg),
the
NOAEL
of
1
mg/
kg/
day
for
short­
term
assessments
(
which
is
also
the
same
value
used
for
the
aPAD),
and
the
uncertainty
factor
of
100
the
amount
of
formulation
that
can
be
consumed
at
the
uncertainty
factor
MOE
level
can
be
calculated.
The
Agency
generally
presents
these
results
based
on
the
number
of
carbaryl
granules
that
can
be
ingested.
However,
the
number
of
homeowner
formulations
is
extensive
and
impossible
to
characterize
in
that
much
detail
so
a
general
weight
estimate
is
presented.
If
a
2
percent
formulation
is
ingested,
7.5
mg
represents
exposure
at
an
MOE
of
100
(
i.
e.,
1.6
x
10­
5
lb).
If
a
10
percent
formulation
is
ingested,
1.5
mg
represents
exposure
at
an
MOE
of
100
(
i.
e.,
3.3
x
10­
6
lb).
70
For
illustrative
purposes,
if
one
considers
a
2
percent
formulation
and
the
density
of
soil
(
0.67
mL/
gram,
many
granulars
are
clay
based),
only
0.005
mL
of
formulation
would
need
to
be
ingested
to
have
a
risk
concern
(
i.
e.,
7.5
mg
*
1g/
1000mg
*
0.67
mL/
gram).
Note
that
this
volume
is
orders
of
magnitude
less
than
a
teaspoon
of
granular
formulation
(
i.
e.,
0.1%
of
a
teaspoon
where
a
tsp.
=
5
mL).

4.4.3.2
Deterministic
Residential
Postapplication
Exposure
and
Risks
For
Cancer
Postapplication
cancer
risks
were
calculated
for
adults
only
considering
the
same
scenarios.
Risks
were
calculated
using
a
frequency
of
one
exposure
per
year
for
50
years.
Cancer
risks
were
calculated
using
a
linear
low­
dose
extrapolation
approach
in
which
a
LADD
is
calculated
and
then
compared
with
a
Q1*
(
8.75
x
10­
4
(
mg/
kg/
day)­
1),
as
described
in
Section
4.4.2.2.
The
number
of
days
of
exposure
per
year
under
a
ceiling
limit
of
cancer
risks
equal
to
1x10­
6
was
also
calculated.

For
all
scenarios
on
turf,
cancer
risks
are
in
the
10­
8
range
or
less
on
the
day
of
application
when
a
single
reentry
event
per
year
during
lawncare
activities
is
evaluated.
For
home
gardening,
golfing
or
from
mosquito
control,
risks
are
slightly
lower
in
the
10­
9
to
10­
12
range
when
a
single
reentry
event
per
year
is
evaluated
on
the
day
of
application.
Table
16
below
summarizes
the
postapplication
risk
values
calculated
for
adults
after
applications
of
carbaryl.
Risk
managers
should
consider
these
values
represent
a
single
reentry
day
into
a
treated
area
over
each
year
of
a
50
year
lifetime
on
the
day
of
application
and
that
the
Agency
lacks
data
to
link
the
annual
frequency
of
reentry
activity
to
residential
applications.
As
with
the
residential
handler
risks
above,
the
Agency
calculated
the
number
of
exposure
days
needed
to
reach
a
risk
level
of
1x10­
6
for
each
scenario
on
the
day
of
application,
values
range
from
20
to
over
365
days
per
year
while
most
exceed
365
days
per
year.

Table
16:
Summary
of
Carbaryl
Postapplication
Residential
Cancer
Risks
For
Adults
Scenario
Descriptor
Results
Risk
on
Day
0
Allowed
Days/
Year
Residential
Turf
(
Lawncare)
Max
Rate
at
4
lb
ai/
A
2.5
x
10­
8
40
Max
Rate
at
8
lb
ai/
A
5.1
x
10­
8
20
Aerial
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
9.5
x
10­
12
to
5.9
x
10­
10
>
365
Ground
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
5.0
x
10­
12
to
3.1
x
10­
10
>
365
Table
16:
Summary
of
Carbaryl
Postapplication
Residential
Cancer
Risks
For
Adults
Scenario
Descriptor
Results
Risk
on
Day
0
Allowed
Days/
Year
71
Golfing
Max
Rate
at
4
lb
ai/
A
1.7
x
10­
9
>
365
Max
Rate
at
8
lb
ai/
A
3.5
x
10­
9
287
Aerial
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
6.5
x
10­
13
to
4.1
x
10­
11
>
365
Ground
­
Mosquito
Adulticide
0.016
to
1.0
lb
ai/
A
3.4
x
10­
13
to
2.1
x
10­
11
>
365
Home
Garden
(
Deciduous
Tree)
Very
Low
Exposure
(
propping)
2.5
x
10­
10
>
365
Low
Exposure
(
irrigation,
scout,
weed)
2.5
x
10­
9
>
365
High
Exposure
(
harvest,
prune,
train,
tie)
3.8
x
10­
9
266
Very
High
Exposure
(
thin)
7.5
x
10­
9
133
Home
Garden
(
Fruiting
Vegetable)
Low
Exposure
(
irrigation,
scout,
thin,
weed)
2.5
x
10­
9
>
365
Medium
Exposure
(
irrigation,
scout)
3.5
x
10­
9
289
High
Exposure
(
harvest,
prune,
stake,
tie)
4.9
x
10­
9
202
Oyster
Beds
Oyster
Harvest
4.5
x
10­
12
>
365
Swimming
6.1
x
10­
12
>
365
4.4.4
Risks
Based
On
Carbaryl
Suburban
Resident
Biomonitoring
Study
This
study
quantified
exposures
in
August
2001
to
carbaryl
via
biological
monitoring
of
inhabitants
in
23
suburban
residences
after
application
of
Sevin
GardenTech
Ready­
to­
Spray
formulation
(
22.5
%
ai
w/
w).
This
formulation
of
carbaryl
is
labeled
for
use
on
lawns,
gardens,
and
ornamentals
for
insect
control.
Ten
families
were
monitored
in
Missouri
and
13
families
were
monitored
in
California.
Six
total
urine
samples
(
24
hour
composites)
were
collected
from
each
resident,
4
years
old
and
above,
beginning
2
days
prior
to
application
and
ending
3
days
after
application
(
i.
e.,
samples
collected
­
2,
­
1,
0,
1,
2,
3
days
after
application).
A
metabolite
of
carbaryl
(
1­
naphthol)
was
measured
and
those
levels
were
used
to
calculate
absorbed
dose
estimates
for
carbaryl.
The
LOQ
or
Limit
of
Quantitation
was
10ppb
or
0.01ppm.
All
totaled,
106
people
were
monitored
including
23
applicators,
28
non­
applicator
adults,
and
55
children
ages
4
to
17.
The
number
of
children,
segmented
by
different
age
groups,
were
as
follows:
4
to
5
years
(
13);
6
to
10
years
(
19);
11
to
15
years
(
20);
and
16
to
17
years
(
3).
The
monitored
families
72
were
from
central
Missouri
near
Columbia
and
southern
California
about
50
miles
east
of
Los
Angeles
in
Riverside.
The
objective
of
this
study
was
to
monitor
people
in
residences
while
they
were
engaged
in
normal
activities.
No
directives
as
to
the
use
of
personal
protective
equipment
or
hygiene
issues
related
to
pesticide
exposure
were
provided
by
the
investigators.
Along
with
1­
naphthol
results,
the
data
provided
for
each
person
in
the
study
included
personal
information
(
age,
weight,
sex,
height);
the
time
they
spent
outdoors
and
the
nature
of
their
activites
(
i.
e.,
in
a
recall
survey,
they
were
asked
if
they
performed
certain
activities
that
could
lead
to
exposure
such
as
yardwork
or
play);
and
information
pertaining
to
the
exposures
received
(
e.
g.,
daily
creatinine
output
and
urine
volumes).

Ready­
to­
Use
hose­
end
sprayer
packages,
which
eliminate
the
need
for
mixing
a
solution
from
concentrated
formulations,
were
used
to
make
all
applications.
Applications
were
made
to
"
lawn
and/
or
garden
or
ornamental"
areas.
The
protocol
for
this
study
required
that
each
family
treat
their
lawn
(
i.
e.,
a
broadcast
style
application)
and
garden
or
ornamental
area
(
i.
e.,
at
all
sites,
lawn
areas
were
treated).
Uses
like
these
represent
a
small
percentage
of
the
overall
United
States
general
population
(
i.
e.,
18
%
of
those
who
treat
lawns
also
treat
their
vegetables
and
44
%
of
those
who
treat
lawns
also
treat
their
ornamentals,
0.5%
of
the
general
population
broadcast
treats
their
lawn
which
could
lead
to
significant
exposure).
However,
the
Agency
believes
that
the
use
pattern
monitored
in
the
study
can
also
be
used
to
represent
treatments
only
to
lawns
because
it
believes
that
most
exposure
in
this
study
either
came
from
time
spent
on
lawns
by
children
or
it
occurred
during
the
application
process.

The
first
step
in
the
analysis
of
the
biological
monitoring
data
was
to
evaluate
the
sample
collection
process.
A
review
of
the
field
sample
collection
procedures
was
completed
and
all
processes
appear
appropriate.
Daily
urine
volumes
and
creatinine
outputs
were
examined
to
establish
the
level
of
variability
within
individuals.
Extremely
variable
results
would
be
an
indication
of
suspect
sampling
events.
Along
with
the
intrapersonal
comparisons
described
above,
comparisons
using
the
daily
output
of
creatinine
of
those
monitored
to
clinically
accepted
values
were
made
to
ensure
complete
collection
compared
to
recognized
values.
Overall,
the
data
appear
to
be
of
sufficient
quality
for
use
in
risk
assessment
as
the
intra­
individual
variability
are
what
would
be
expected
and
the
results
indicate
that
most
samples
compare
well
with
established
clinical
reference
values
indicating
complete
sample
collection
in
this
study.

The
investigators
corrected
results
for
1­
naphthol
in
individual
samples
if
creatinine
levels,
urine
volumes,
or
other
parameters
were
aberrant
based
on
the
use
of
statistical
tests
to
define
outlier
results.
After
the
1­
naphthol
concentrations
were
defined,
carbaryl
absorbed
dose
estimates
were
calculated
using
factors
determined
in
an
analysis
of
pertinent
pharmacokinetic
data
(
including
human
studies)
conducted
by
Bayer.
Bayer
indicated
"
the
recommended
stoichiometric
conversion
factor
to
represent
recent
(
within
96
hours
post­
exposure)
1­
naphthol
measurements
in
human
urine
samples
as
estimates
of
carbaryl­
absorbed
dose
is
3.5
[
i.
e.,
1­
naphthol
normalized
concentration
(
per
L)
or
dose
(
per
kg
body
weight),
corrected
for
analytical
method
recovery
efficiency,
x
3.5
=
carbaryl
concentration
or
dose.]"
The
3.5
factor
was
derived
by
multiplying
a
stoichiometric
conversion
factor
based
on
molecular
weight
differences
between
carbaryl
and
1­
naphthol
(
i.
e.,
1.4
=
MW
carbaryl
201.2/
MW
1­
naphthol
144.2)
by
the
partition
coefficient
of
2.5
developed
based
on
the
3
human
oral
studies
that
indicate
40
percent
of
the
administered
dose
is
eliminated
in
the
urine
(
i.
e.,
1.4
x
2.5
=
3.5).
The
other
key
piece
of
information
is
the
time
it
takes
for
a
single
dose
to
be
eliminated
in
humans.
The
excretion
profile
indicates
that
it
takes
73
96
hours
for
a
single
dose
to
be
eliminated
and
that
approximately
50
percent
is
eliminated
throughout
the
first
24
hours
after
an
exposure
event
then
the
rest
in
a
steadily
declining
mode
out
to
total
elimination
at
96
hours.

The
pharmacokinetic
factors
and
correction
factors
for
defining
1­
naphthol
concentrations
apply
to
each
exposure
event
that
could
occur.
With
this
study,
there
are
additional
considerations
because
of
the
non­
controlled
nature
of
the
activities
of
those
monitored
(
i.
e.,
many
exposure
events
could
occur
per
person).
As
a
result,
there
are
several
possible
approaches
for
calculating
dose
levels
that
would
be
used
for
risk
assessment
purposes
because
of
the
duration
it
takes
to
eliminate
carbaryl
residues
from
the
body
and
the
associated
excretion
profile
(
i.
e.,
50
%
in
24
hours,
total
in
96
hours).
In
order
to
complete
a
comprehensive
analysis,
the
Agency
has
considered
the
data
in
several
ways
including:

°
Post­
Application
Total
Dose:
All
post­
application
dose
values
were
added
together
over
the
sample
collection
timeframe
of
96
hours.
The
justification
for
this
approach
is
that
it
takes
96
hours
for
carbaryl
residues
to
be
eliminated
from
the
body
(
i.
e.,
the
length
of
post­
application
monitoring
in
the
study).
There
are
considerations
because
it
can
overestimate
dose
if
there
are
multiple
exposures
on
separate
days
but
it
could
also
underestimate
dose
if
significant
contributing
events
to
the
overall
dose
occurred
at
a
later
point
in
the
monitoring
thus
leading
to
an
incomplete
sample
collection.

°
Individual
Daily
Dose:
Dose
estimates
were
calculated
based
on
results
for
each
individual
person­
day
monitored
in
the
study.
This
approach
was
used
by
Bayer
in
their
analysis
of
the
data.
There
are
considerations
because
it
assumes
what
could
be
called
a
"
quasi­
steady
state
approach"
but
it
does
not
account
for
mass
balance
over
the
96
hours
needed
to
eliminate
residues
which
could
severely
underestimate
exposures.
Based
on
the
pharmacokinetic
information,
only
50
percent
of
carbaryl
residues
are
eliminated
on
the
first
day
after
exposure.

°
Individual
Daily
Dose
Corrected
For
Mass
Balance:
The
individual
person­
day
dose
estimates
were
used
but
they
were
corrected
for
mass
balance
observed
in
the
pharmacokinetic
analysis
which
indicated
only
50
percent
of
carbaryl
residues
are
eliminated
on
the
first
day
after
exposure.

[
Note:
The
Agency
evaluated
the
data
in
the
manner
described
above
to
examine
the
differences
in
each
approach
and
the
impacts
upon
the
ultimate
risk
calculations.
The
differences
which
were
identified
are
described
below
and
a
recommendation
to
use
the
Post­
Application
Total
Dose
for
regulatory
use
is
provided.
The
other
estimates
are
provided
only
for
comparative
purposes.]

The
next
step
was
to
group
data
for
individuals
based
on
factors
that
included
location,
age,
gender,
and
applicator
status
to
statistically
summarize
the
data
and
to
examine
if
there
were
relationships
between
factors
such
as
application
rate
or
time
spent
outside
and
dose.
The
summarized
data
for
4
to
5
year
olds
(
N=
13)
is
presented
in
Table
17
as
an
example
of
the
statistics
that
were
calculated
for
each
population
of
interest.
74
Table
17:
Summary
Statistics
For
Children
(
4
to
5
years)
Who
Reside
In
Houses
Where
Lawns
And/
Or
Gardens
Were
Treated
Statistic
Age
(
Yrs)
Applied
(
lb
ai)
Area
Treated
(
ft2)
Appl.
Rate
(
lbai/
1000
ft2)
Total
Time
Outdoors
(
Min.)
Post
Application
Total
Dose
(
µ
g/
kg/
day)
Individual
Daily
Dose
(
µ
g/
kg/
day)
Corrected
Individual
Daily
Dose
(
µ
g/
kg/
day)

Avg.
4.4
0.813
5961
0.327
256
44.6
11.2
22.3
Minimum
4
0.562
400
0.047
0
0.6
0
0
Maximum
5
1.350
12000
1.404
1200
219.9
126.0
252.0
Median
4
0.901
6707
0.144
60
21.9
4.5
9.0
25th
%
tile
4
0.562
1400
0.104
45
12.3
1.6
3.2
75th
%
tile
5
0.901
9404
0.401
240
39.2
10.0
19.9
95th
%
tile
5
1.350
11565
0.983
966
164.9
57.4
114.8
99th
%
tile
5
1.350
11913
1.320
1153
208.9
97.7
195.4
The
Total
Time
Outdoors
represents
the
total
amount
of
time
spent
outdoors
by
the
subjects
on
the
day
of
application
and
all
monitored
days
thereafter.
The
Post
Application
Total
Dose
represents
carbaryl
equivalent
dose
residues
in
urine
added
together
from
the
day
of
application
through
the
last
day
of
monitoring
as
the
excretion
profile
of
carbaryl/
1­
naphthol
indicates
a
96
hour
clearance
interval.
Individual
Daily
Dose
estimates
represent
24
hour
person­
day
samples
not
corrected
for
mass
balance
or
adjusted
with
any
other
pharmacokinetic
factor.
Corrected
Individual
Daily
Dose
estimates
represent
24
hour
person­
day
samples
which
have
been
corrected
for
50
percent
mass
balance/
elimination
on
each
day
sampled.
[
Note:
The
Agency
recommends
Post
Application
Total
Dose
values
for
regulatory
action
because
they
account
for
mass
balance
and
are
conservative
in
nature
compared
with
the
other
approaches.]

In
order
to
develop
a
better
understanding
of
the
exposures
that
occurred
in
this
study,
the
Agency
completed
a
series
of
regression
analyses
that
compared
exposures
for
different
groups
(
e.
g.,
applicators
and
non­
applicator
adults)
against
several
elements
of
the
supporting
data.
For
applicators,
exposures
were
compared
against
factors
that
included:
the
amount
of
active
ingredient
applied;
the
application
rate;
and
the
time
spent
outdoors
on
the
day
of
application.
[
Note:
In
one
case,
no
duration
was
reported
so
the
Agency
used
a
value
of
1
minute
for
calculation
purposes.]
Similar
analyses
were
completed
for
non­
applicator
adults
and
children.
Analyses
also
were
completed
using
an
approach
that
considered
whether
location,
age,
or
gender
played
roles
in
exposure
trends.
The
Agency
also
completed
regressions
for
each
non­
applicator
individual
to
define
if
the
time
spent
outdoors
on
a
daily
basis
correlated
with
their
daily
exposures.
This
showed
no
clear
cut
trend
between
daily
dose
and
daily
time
spent
outdoors.
[
Note:
This
analysis
was
not
completed
for
applicators
since
it
is
clear
in
their
case
that
the
amount
ai
handled
per
day
is
critical
to
their
exposure.]
The
results
of
the
analyses
based
on
total
exposure
for
each
group
are
presented
in
Table
18.
75
Table
18:
Total
Exposure
Regression
Analysis
Results
For
Carbaryl
Suburban
Resident
Biomonitoring
Study
Population
Subset
Correlation
Coefficients
Total
Exp
vs.
AI
Applied
Total
Exp
vs.
Appl.
Rate
Total
Exp
vs.
Duration
Applicators
MO
0.257
0.122
0.205
CA
NA­
all
ai
same
0.077
0.750
All
0.535
0.235
0.437
Non­
applicator
Adult
MO
0.436
0.075
0.140
CA
NA­
all
ai
same
0.034
0.572
All
0.028
0.007
0.371
Children
­
All
Ages
MO
0.018
0.257
0.414
CA
NA­
all
ai
same
0.066
0.164
All
0.215
0.069
0.095
Children
­
All
Locations
4
to
5
yrs
0.404
0.228
0.677
6
to
10
yrs
0.328
0.268
0.039
11
to
15
yrs
0.449
0.001
0.192
16
to
17
yrs
0.888
0.780
0.972
Results
were
similar
for
all
locations
and
age
groups
when
children
were
further
subdivided
by
gender
and
a
regression
analysis
completed.
A
rank
order
analysis
also
shows
that
5
of
the
10
children
with
the
highest
total
dose
in
the
entire
monitored
children's
population
were
in
the
11
to
15
year
old
age
group.

The
results
of
the
regression
analysis
for
all
groups
was
in
many
ways
inconclusive
because
there
appeared
to
be
little
association
between
total
exposures
and
any
single
exposure
parameter
that
was
examined.
Some
of
the
parameters,
however,
did
appear
to
be
more
highly
associated
with
exposures
in
certain
cases
compared
to
others.
Results
for
the
16
to
17
year
old
children
should
also
be
considered
circumspect
because
the
size
of
the
population
for
this
analysis
was
only
3
individuals.
For
applicators,
it
does
appear
that
the
amount
of
active
ingredient
handled
might
be
the
best
indicator
of
exposure
although
it
is
confounded
by
the
lack
of
a
result
for
California
because
all
applicators
there
used
identical
amounts
of
chemical
making
the
analysis
impossible.
When
the
entire
group
was
considered
though,
this
parameter
appears
to
have
the
highest
association
(
i.
e.,
the
correlation
coefficient
is
0.535).
Proximity
to
the
source
of
exposure
(
i.
e.,
time
spent
outdoors)
appears
to
be
the
most
associated
parameter
to
overall
exposure
for
those
who
were
not
involved
in
the
application
process
regardless
of
whether
or
not
they
were
adults
or
children.
In
fact,
this
parameter
had
the
largest
correlation
coefficient
(
i.
e.,
highest
association)
for
a
majority
of
the
scenarios
considered
(
i.
e.,
6
of
10).
Further
delineation
of
the
population
based
on
gender
or
location
had
no
discernible
effect.
The
results
of
this
analysis
were
not
unexpected
to
the
Agency
because
of
the
complex
nature
of
the
residential
environments
that
were
evaluated
in
this
study.
None
of
the
parameters
which
were
possibly
key
indicators
of
exposure
were
76
controlled.
As
such,
the
Agency
has
treated
the
data
from
this
study
as
a
representative
population
for
situations
where
there
have
been
applications
to
lawns
and
gardens
or
ornamentals
with
carbaryl.
Finally,
it
should
also
be
noted
that
application
rate
in
most
cases
has
the
weakest
correlation
in
all
populations
when
it
is
compared
to
dose.

Bayer
also
completed
an
analysis
of
the
biomonitoring
data.
The
following
list
of
"
key
findings"
were
excerpted
directly
from
their
analysis:

°
"
The
exposure
to
applicators
applying
carbaryl
by
hose­
end
spray
applicator
were
comparable
to
the
ORETF
hose­
end
sprayer
exposure
study.
°
Pre­
application
1­
naphthol
urine
levels
were
comparable
to
1­
naphthol
levels
reported
from
the
NHEXAS
surveys.
°
The
4
to
12
year
age
group
had
the
highest
overall
exposure
of
all
cohort
groups
in
the
study.
°
Yard
activity
was
the
primary
determinant
for
post­
application
exposure
potential.
°
Application
rate
played
less
significant
role
in
post­
application
exposure
and
the
required
postapplication
activity
with
treated
areas
to
affect
the
exposure
potential.
°
Secondary
routes
of
exposure
such
as
vapor
intrusion,
track­
in,
or
dust
levels
appear
to
be
insignificant
sources
of
exposure.
°
Results
from
this
study
indicates
that
the
Agency
assessment
of
residential
exposure
overestimates
actual
monitored
exposures
because
it
overestimates
the
actual
amount
of
active
ingredient
handled
and
the
standardized
activity
pattern
routines
greatly
overestimates
the
actual
contact
with
treated
turf.
°
All
cohorts
had
daily
mean
margins
of
exposure
that
exceeded
100."

The
Agency
concurs
with
all
of
these
conclusions
except
the
last
two.
The
Agency
completed
an
analysis
that
compared
the
Agency's
approach
against
the
approach
used
by
Bayer
which
indicates
that
the
Bayer
approach
consistently
provides
lower
exposure
estimates
than
believed
appropriate
by
the
Agency
(
Table
19).
Additionally,
the
Agency's
analysis
of
the
Residential
Exposure
Joint
Venture's
use
information
for
carbaryl
does
not
preclude
the
use
of
the
exposure
factors
(
e.
g.,
use
rate
or
amount
applied)
contained
in
the
previous
assessment.
It
should
also
be
noted
that
risk
estimates
were
calculated
using
geometric
mean
individual
daily
dose
values
which
were
not
corrected
for
mass
balance
as
defined
by
Bayer's
own
pharmacokinetic
analysis.
77
Table
19:
Dose
Levels
Calculated
By
Bayer
Based
On
Suburban
Resident
Biomonitoring
Study
Population
Location
Carbaryl
Geometric
Mean
Dose
Values
Calculated
By
Bayer
(
µ
g/
kg/
day)
Agency
Arith.
Mean
Dose
(
µ
g/
kg/
day)

Individual
Daily
Dose
Day
0
Individual
Daily
Dose
Day
1
Individual
Daily
Dose
Day
2
Individual
Daily
Dose
Day
3
Post­
Application
Total
Dose
(
Agency
Approach)
Individual
Daily
Dose
All
Days
Post­
Application
Total
Dose
Applicators
MO
8.3
6.1
2.6
1.9
18.9
NA
NA
CA
1.7
1.6
1.1
1.8
6.2
NA
NA
All
NA
NA
NA
NA
NA
4.8
19.1
Bayer
MOE
on
Day
0
in
MO
=
120.
MOEs
for
total
dose
estimates
based
on
geometric
means
are
53
in
MO
and
161
in
CA.

Non­
Applicator
Adults
MO
0.57
0.77
0.92
1.85
4.1
NA
NA
CA­
spouse
0.54
0.96
0.83
0.42
2.8
NA
NA
CA­
resident
2.27
1.32
0.92
2.89
7.4
NA
NA
All
NA
NA
NA
NA
NA
2.0
8.1
Bayer
MOE
on
Day
3
in
CA
resident
=
346.
MOEs
for
their
total
dose
estimates
based
on
geometric
means
are
243
in
MO
and
135
in
CA
residents.

Children
Ages
13
­
17
MO
1.46
2.17
0.89
1.49
6.01
NA
NA
CA
0.49
2.20
5.85
5.60
14.14
NA
NA
All
NA
NA
NA
NA
NA
7.88
31.5
Bayer
MOE
on
Day
2
in
CA
=
171.
MOEs
for
their
total
dose
estimates
based
on
geometric
means
are
166
in
MO
and
70.7
in
CA.
[
Note:
Agency
values
based
on
11
to
15
year
olds.]

Children
Ages
4­
12
MO
1.96
3.26
1.50
3.32
10.04
NA
NA
CA
3.19
6.10
7.98
5.10
22.37
NA
NA
All
NA
NA
NA
NA
NA
19.56
78.3
Bayer
MOE
on
Day
2
in
CA
=
125.
MOEs
for
their
total
dose
estimates
based
on
geometric
means
are
100
in
MO
and
44.7
in
CA.[
Note:
Agency
values
based
on
6
to
10
year
olds.]

4.4.4.1
Noncancer
Risks
Based
On
Biological
Monitoring
Data
The
results
of
this
study
were
presented
by
the
investigators
as
the
absorbed
dose
of
carbaryl
for
each
individual
(
µ
g/
kg/
day)
which,
in
turn,
were
used
by
the
Agency
to
calculate
statistical
summaries
of
the
data
for
different
groups.
These
statistical
summaries
were
then
used
to
calculate
risk
estimates.
As
described
above,
the
dose
values
can
be
calculated
in
different
manners
that
include
(
1)
ignoring
mass
balance
in
the
excretion
profile
and
using
the
daily
values
as
reported
(
i.
e.,
Individual
Daily
Dose);
(
2)
78
correcting
daily
values
for
mass
balance
with
a
50
percent
factor
(
i.
e.,
Individual
Daily
Dose
Corrected
For
Mass
Balance);
and
(
3)
adding
daily
dose
estimates
together
over
the
monitoring
period
(
i.
e.,
Post­
Application
Total
Dose).
A
scientific
case
can
be
made
for
calculating
dose
levels
to
be
used
in
risk
assessment
in
each
manner.
However,
the
Agency
believes
that
the
total
dose
approach
is
the
most
appropriate
because
it
is
the
most
conservative
with
regard
to
contributions
from
exposure
on
previous
days
and
it
accounts
for
mass
balance.
It
should
also
be
considered
that
the
use
of
individual
values
may
likely
underestimate
dose
because
of
the
lack
of
correction
for
mass
balance
making
the
results
incomplete.
The
individual
values
which
have
been
corrected
for
mass
balance
also
appear
to
be
appropriate
for
risk
analysis.
However,
there
is
little
difference
between
corrected
highest
daily
values
and
total
dose
estimates.
As
described
earlier,
noncancer
risks
were
calculated
by
comparing
absorbed
dose
estimates
to
the
short­
term
oral
endpoint.
The
calculated
noncancer
risks
based
on
Bayer's
approach
and
the
Agency's
approach
are
summarized
below
in
Table
20.

Table
20:
Noncancer
Risk
Estimates
For
Carbaryl
Based
On
Suburban
Resident
Biomonitoring
Study
Statistic
Used
Noncancer
MOEs
Applicator
Nonapplicator
adult
All
Children
4
to
5
years
old
6
to
10
years
old
11
to
15
years
old
16
to
17
years
old
MOEs
Calculated
Based
On
Post­
Application
Total
Dose
Values
(
Agency
Recommended
Method)

Avg.
52.5
124.0
20.3
22.4
12.8
31.7
268.9
Min.
673.0
1494.8
1796.0
1796.0
1030.6
358.2
533.6
Max.
18.3
25.8
1.0
4.6
1.0
7.6
158.3
Median
76.6
146.8
62.0
45.6
54.0
62.1
337.3
25th
%
tile
228.3
328.8
128.4
81.4
120.6
118.2
158.3
75th
%
tile
36.7
103.3
26.5
25.5
25.4
27.4
27.6
95th
%
tile
19.6
60.8
7.7
6.1
4.8
11.9
8.9
99th
%
tile
18.5
30.3
1.7
4.8
1.2
8.2
7.7
MOEs
Calculated
Based
On
Individual
Daily
Dose
Values
Not
Corrected
For
Mass
Balance
(
Bayer
Calculation
Method)

Avg.
209.9
495.9
81.2
89.7
51.1
126.9
1075.5
Min.
NA
NA
NA
NA
NA
4032.3
NA
Max.
39.2
79.4
2.2
7.9
2.2
14.7
416.7
Median
386.9
743.5
369.0
221.7
373.8
381.0
1207.0
25th
%
tile
934.6
1675.0
826.5
619.2
704.2
871.5
2585.7
75th
%
tile
180.6
360.4
124.7
100.4
130.2
122.9
763.4
95th
%
tile
54.9
193.8
21.6
17.4
17.5
25.3
496.3
99th
%
tile
45.4
82.6
5.4
10.2
2.7
16.8
430.5
79
It
is
clear
that
the
manner
in
which
noncancer
risks
are
calculated
has
an
impact
on
the
resulting
risks.
For
both
calculation
techniques,
however,
the
Agency
has
a
concern
(
i.
e.,
MOEs<
100)
at
the
upper
percentiles
of
exposure
regardless
of
how
the
dose
estimate
was
calculated
for
adult
applicators
and
children
alike
(
e.
g.,
95th
%
tile
and
up).
In
the
Agency's
approach,
risks
are
still
of
concern
based
on
whatever
measure
of
central
tendency
is
considered
for
all
populations
except
older
children.
If
single
day
values
are
considered
(
Bayer's
approach),
risks
are
not
of
concern
based
on
geometric
mean
values
but
are
of
concern
if
the
arithmetic
mean
is
considered
for
children
under
10
years
of
age.
Risks
are
of
most
concern
for
applicators
and
the
youngest
children
because
they
have
the
highest
dose
levels
as
would
be
expected
(
i.
e.,
applicators
are
in
proximity
to
product
and
young
children
spent
time
outdoors
on
treated
lawns).
In
summary,
the
biological
monitoring
study
clearly
illustrates
that
exposures
leading
to
risks
of
concern
for
applicators
and
younger
children
can
occur
in
households
where
carbaryl
is
used.
Additionally,
risks
are
of
concern
at
the
highest
percentiles
of
exposure
(
95th
%
tile
and
up)
regardless
of
how
dose
estimates
are
calculated.
It
should
be
kept
in
mind
that
the
Agency's
approach
could
overestimate
exposures
because
of
adding
daily
dose
estimates
together.
It
should
also
be
noted
that
Bayer's
approach
does
not
account
for
mass
balance
as
defined
in
the
pharmacokinetic
analysis
of
the
excretion
profile
for
carbaryl.

4.4.4.2
Cancer
Risks
Based
On
Biological
Monitoring
Data
The
Agency
also
used
the
absorbed
dose
estimates
to
calculate
cancer
risks
for
applicators
and
non­
applicator
adults.
Cancer
risks
were
calculated
by
assuming
the
dose
estimates
represent
a
single
day
of
exposure
per
year
over
a
lifetime
of
70
years,
50
of
which
are
involved
in
gardening.
The
allowable
number
of
days
of
exposure
allowed
per
year
over
that
50
years
of
gardening
in
a
lifetime
were
then
calculated
using
1x10­
6
as
an
acceptable
risk
limit
(
Table
21).

Table
21:
Cancer
Risk
Estimates
For
Carbaryl
Based
On
Suburban
Resident
Biomonitoring
Study
Statistic
Used
Risks
Calculated
Based
On
1
Day
Expo/
Yr.
Allowable
Expo
Days/
Year
Under
Target
App.
Risks
Non­
app
Adult
Risks
App.
Non­
app
Adult
Cancer
Risks
Calculated
Based
On
Post­
Application
Total
Dose
Values
(
Agency
Recommended
Method)

Avg.
3.26E­
008
1.38E­
008
31
72
Min.
2.54E­
009
1.15E­
009
>
365
>
365
Max.
9.35E­
008
6.64E­
008
11
15
Median
2.24E­
008
1.17E­
008
45
86
25th
%
tile
7.50E­
009
5.21E­
009
133
192
75th
%
tile
4.66E­
008
1.66E­
008
21
60
95th
%
tile
8.75E­
008
2.82E­
008
11
35
99th
%
tile
9.25E­
008
5.65E­
008
11
18
Cancer
Risks
Calculated
Based
On
Individual
Daily
Dose
Values
Not
Corrected
For
Mass
Balance
(
Bayer
Calculation
Method)
Table
21:
Cancer
Risk
Estimates
For
Carbaryl
Based
On
Suburban
Resident
Biomonitoring
Study
Statistic
Used
Risks
Calculated
Based
On
1
Day
Expo/
Yr.
Allowable
Expo
Days/
Year
Under
Target
App.
Risks
Non­
app
Adult
Risks
App.
Non­
app
Adult
80
Avg.
8.16E­
009
3.45E­
009
123
290
Min.
NA
NA
NA
NA
Max.
4.37E­
008
2.16E­
008
23
46
Median
4.43E­
009
2.30E­
009
226
>
365
25th
%
tile
1.83E­
009
1.02E­
009
>
365
>
365
75th
%
tile
9.48E­
009
4.75E­
009
105
210
95th
%
tile
3.12E­
008
8.84E­
009
32
113
99th
%
tile
3.77E­
008
2.07E­
008
26
48
It
is
clear,
as
with
the
deterministic
assessments
described
above,
that
cancer
risks
are
not
the
key
concern
for
the
Agency
compared
with
the
noncancer
MOEs
which
have
been
calculated.
When
the
allowable
number
of
exposure
days
per
year
are
calculated
over
a
50
year
lifetime,
the
lowest
estimate
based
on
the
Agency's
calculation
approach
was
11
days
per
year
which
exceeds
carbaryl
use
frequency
as
defined
in
the
Sevin
User
Survey
and
the
Residential
Exposure
Joint
Venture
survey
of
residential
use.
In
this
case,
the
manner
in
which
risks
are
calculated
(
i.
e.,
single
day
versus
total
dose)
does
not
substantively
impact
the
results.

4.4.5
Residential
Risk
Characterization
Characterization
of
each
of
the
individual
components
of
the
residential
assessment
is
provided
below.
The
Agency
also
urges
readers
to
consider
the
results
presented
in
this
document
in
the
context
of
associated
probabilistic
assessments
should
they
become
available.

Residential
Handler
Risks
Based
On
Deterministic
Approaches:
The
residential
handler
assessment
for
carbaryl
is
complex
in
that
calculations
were
completed
for
54
different
equipment
and
application
rate
scenarios.
Unlike
the
occupational
assessments,
only
short­
term
exposures
were
considered
for
handlers
because
homeowner
use
patterns
are
not
believed
by
the
Agency
to
lead
to
intermediate­
term
exposures
because
of
their
sporadic
nature.
Cancer
risks
were
calculated
using
a
linear,
low­
dose
extrapolation
model
(
i.
e.,
Q1*)
for
typical
residential
users
(
1
event/
year).
Cancer
risks
were
also
considered
by
calculating
the
number
of
days
exposure
that
would
be
required
per
year
to
achieve
a
cancer
risk
of
1x10­
6
to
illustrate
risk
levels
from
another
perspective.
All
totaled,
when
each
type
of
calculation
is
considered,
108
different
crop/
application
method
calculations
were
completed
for
residential
handlers.

The
data
that
were
used
in
the
in
the
carbaryl
residential
handler
assessment
represent
the
best
data
and
approaches
that
are
currently
available.
For
most
of
the
major
use
patterns,
carbaryl­
specific
81
data
or
data
generated
by
the
Outdoor
Residential
Exposure
Task
Force
were
used.
These
data
generally
are
considered
to
be
high
quality
by
the
Agency
and
the
best
source
of
information
available
for
the
scenarios
where
they
were
used.
Carbaryl­
specific
data
were
used
to
address
the
garden
and
tree/
ornamental
scenarios
with
several
types
of
equipment
and
formulations
including
liquid
trigger
sprayers,
dusts,
and
liquid
sprays
using
low
pressure
handwand
and
hose­
end
sprayers.
Carbaryl­
specific
data
were
also
available
for
dusting
dogs.
The
ORETF
data
for
hose­
end
sprayer
applications
to
turf
and
granular
applications
to
turf
were
also
used
to
address
those
scenarios.
In
the
remaining
scenarios,
the
Pesticide
Handlers
Exposure
Database
(
PHED)
was
used
to
develop
the
unit
exposure
values.
The
quality
of
the
data
included
in
PHED
vary
widely
from
scenarios
that
meet
guideline
requirements
for
studies
to
others
where
a
limited
number
of
poor
quality
datapoints
are
available.
All
data
that
have
been
used
may
not
be
of
optimal
quality
but
represent
the
best
available
data.

The
inputs
for
application
rate
and
other
use/
usage
information
(
e.
g.,
area
treated
and
frequency
of
use)
used
by
the
Agency
were
supported
by
the
available
carbaryl
labels
and
information
supplied
by
the
Bayer
Corporation
at
the
September
24,
1998
SMART
Meeting.
It
is
also
very
clear
that
because
carbaryl
is
such
as
widely
used
chemical
that
it
is
likely
every
potential
exposure
scenario
has
not
been
captured
because
of
differences
in
use
pattern.

There
are
also
many
uncertainties
in
the
assessment
that
are
common
with
the
occupational
assessment
as
well.
These
factors
and
their
impacts
on
the
results
should
be
considered
as
well
in
the
interpretation
of
the
results
for
residential
handlers.

In
summary,
with
respect
to
residential
handler
risks,
the
Agency
believes
that
the
values
presented
in
this
assessment
represent
the
highest
quality
results
that
could
be
produced
given
the
exposure,
use,
and
toxicology
data
that
are
available.
However,
there
are
certain
elements
where
additional
data
are
required.
For
example,
it
is
difficult
to
ascertain
where
on
a
distribution
certain
input
values
may
fall
because
the
distributional
data
for
exposure,
application
rates,
acres
treated
and
many
other
parameters
are
unrefined.

Residential
Postapplication
Risks
Based
On
Deterministic
Approaches:
Like
the
residential
handler
assessment
discussed
above,
the
postapplication
residential
assessment
for
carbaryl
is
also
complex
in
that
noncancer
MOE
calculations
were
required
along
with
cancer
risk
calculations
using
a
linear,
low­
dose
extrapolation
model.
Carbaryl
residues
persist
in
the
environment
as
indicated
in
the
available
DFR
and
TTR
data
for
extended
periods
where
intermediate­
term
along
with
short­
term
noncancer
risk
estimates
are
required.
Cancer
risks
were
calculated
only
for
adults
per
current
Agency
policy.

The
general
population
can
be
exposed
through
many
different
pathways
that
result
from
uses
on
lawns
and
turf,
in
gardens,
on
ornamental
plants,
and
from
treated
pets.
People
can
also
be
exposed
from
mosquito
adulticide
applications
and
uses
in
oyster
beds.
Carbaryl
labels
do
not
currently
allow
for
indoor
residential
uses
(
e.
g.,
crack
and
crevice).
Settings
where
such
exposures
could
occur
would
include
around
personal
residences
and
in
other
areas
frequented
by
the
general
public
including
parks,
ball
fields,
golf
courses,
and
playgrounds.
To
represent
the
wide
array
of
possible
exposures,
the
Agency
relies
on
the
scenarios
that
have
been
defined
in
the
SOPs
For
Residential
Exposure
Assessment
and
82
accompanying
documents
such
as
the
overview
presented
to
the
FIFRA
Science
Advisory
Panel.
For
turf
uses,
the
Agency
considered
adults
and
toddlers
(
3
year
olds)
in
the
assessments.
Adult
activities
included
lawncare/
maintenance
and
also
golfing.
Toddler
MOEs
were
calculated
for
playing
on
turf
(
using
exposure
data
from
the
Jazzercize
model)
and
also
addressed
nondietary
ingestion
(
hand­/
objectto
mouth
and
soil
ingestion).
Exposures
from
tree
and
garden
uses
were
evaluated
by
considering
adults
and
youth­
aged
children
(
10
to
12
years
old)
doing
gardening
activities
such
as
weeding
and
harvesting
for
different
crops.
Transfer
coefficients
from
the
fruiting
vegetable
crop
group
and
the
deciduous
tree
crop
group
were
used,
as
described
in
the
SOPs
For
Residential
Exposure
Assessment
to
represent
exposures
for
these
scenarios.
MOEs
from
treated
pets
were
evaluated
for
toddlers
again
for
whom
exposures
may
occur
from
dermal
contact
and
hand­
to­
mouth
behavior.
Adulticide
mosquito
applications
were
considered
by
first
defining
how
much
residues
are
deposited
on
the
ground
after
a
mosquito
control
application
then
using
the
same
methods
approaches
from
the
lawncare
assessment
to
address
adults
doing
heavy
yardwork
or
golfing
and
also
children
playing
on
treated
turf.

The
data
that
were
used
in
the
carbaryl
residential
postapplication
assessment
represent
the
best
data
and
approaches
that
are
currently
available.
To
the
extent
possible,
the
Agency
has
attempted
to
use
carbaryl­
specific
data
such
as
with
the
dislodgeable
foliar
residue
(
DFR)
data
used
for
the
garden
scenarios,
transferable
pet
residue
data
from
the
collar
study,
and
the
turf
transferable
residue
(
TTR)
data
for
the
dermal
component
of
the
turf
scenarios.
When
chemical­
specific
data
were
unavailable,
the
Agency
used
the
current
approaches
for
residential
assessment,
many
of
which
include
recent
upgrades
to
the
SOPs.
For
example,
for
the
toddler
hand­
to­
mouth
calculations,
the
TTR
data
were
not
used
but
a
5
percent
transferability
factor
was
applied
to
calculate
residue
levels
appropriate
for
this
exposure
pathway.
Another
key
approach
to
consider
is
the
use
of
the
dermal
hug
approach
for
pet
products
which
was
proposed
at
the
September
1999
meeting
of
the
FIFRA
Science
Advisory
Panel.
Oyster
bed
uses
were
evaluated
based
on
guidance
from
Superfund
and
the
Agency's
SWIMODEL.
There
are
also
many
embedded
uncertainties
that
should
be
considered
in
the
interpretation
of
this
assessment
such
as
those
associated
with
the
use
of
Jazzercize
and
with
the
nondietary
ingestion
calculations.
Readers
should
consider
these
in
the
interpretation
of
the
overall
risk
estimates.
Readers
should
also
consider
the
screening
nature
of
the
SOPs
For
Residential
Exposure
Assessment
and
how
additional
data
could
refine
the
results.

Finally,
the
Agency
believes
that
the
values
presented
in
this
assessment
represent
the
highest
quality
results
that
could
be
produced
based
on
the
currently
available
postapplication
exposure
data.
Readers
of
this
document
should
consider
the
quality
of
individual
inputs
when
interpreting
the
results
and
make
decisions
accordingly.
It
is
difficult
to
ascertain
where,
on
a
distribution,
the
calculated
values
fall
because
the
distributional
data
for
exposure,
residue
dissipation
and
many
other
parameters
are
unrefined.
The
Agency
does
believe,
however,
that
the
risks
represent
conservative
estimates
of
exposure
because
maximum
application
rates
are
used
to
define
residue
levels
upon
which
the
83
calculations
are
based.
Additionally,
estimates
are
thought
to
be
conservative
even
when
measures
of
central
tendency
(
e.
g.,
most
transfer
coefficients
are
thought
to
be
central
tendency)
are
used
because
values
that
would
be
considered
to
be
in
the
lower
percentile
aspect
of
any
input
parameter
have
not
been
used
in
the
calculations.

Residential
Risks
Based
On
Suburban
Resident
Biological
Monitoring
Study:
The
use
of
biological
monitoring
can
be
a
powerful
tool
in
the
risk
assessment
process.
However,
study
design
issues
and
the
representativeness
of
the
population
must
be
thoroughly
understood
in
order
to
assure
that
the
results
are
considered
in
the
appropriate
context.
Additionally,
technical
issues
associated
with
the
interpretation
of
the
study
also
need
to
be
thoroughly
understood.
The
Residential
Exposure
Joint
Venture
survey
results
indicate
that
carbaryl
use
on
lawns
represents
about
1.2
percent
of
the
general
population.
This
population
decreases
accordingly
when
concurrent
on
vegetables
or
ornamentals
is
considered.
In
fact,
only
18
percent
of
the
lawn
user
population
also
uses
carbaryl
on
their
vegetables
and
44
percent
also
use
it
on
their
ornamentals.
The
survey
also
indicated
that
about
50
percent
of
all
lawn
use
is
a
spot­
type
treatment
which
is
not
anticipated
by
the
Agency
to
represent
a
major
source
of
exposure.
These
population
estimates
are
presented
here
because
it
is
necessary
to
describe
the
nature
of
the
population
which
was
evaluated
in
the
biological
monitoring
study.
There
is
one
caveat
to
this
analysis
in
that
the
Agency
believes
that
most
of
the
exposures
in
the
study
come
from
either
the
application
process
or
contact
with
treated
turf
because
applicators
and
small
children
had
the
highest
exposures
in
the
study.
As
such,
the
fact
that
concurrent
applications
were
made
to
gardens
or
ornamentals
probably
has
little
bearing
on
the
overall
exposure
patterns.
With
this
in
mind,
the
Agency
believes
that
the
population
evaluated
in
this
study
can
easily
be
used
to
represent
lawn
broadcast
applications
as
well
as
the
concurrent
application
scenarios
examined
in
the
study.

An
analysis
was
completed
that
compared
varying
exposure
statistics
for
the
different
groups
of
individuals
in
the
biological
monitoring
study
to
the
deterministic
scenarios
that
were
included
in
the
Agency's
assessment.
For
most
of
the
homeowner
applicator
scenarios,
the
biological
monitoring
data
for
applicators
exceeds
the
body
burden
estimates
which
were
calculated
in
the
deterministic
assessment
regardless
of
the
exposure
statistic
selected.
In
most
cases,
the
results
are
within
a
factor
of
5
or
so
indicating
good
basic
agreement
between
the
two
approaches.
Results
are
similar
for
the
post­
application
scenarios
when
they
are
compared
to
the
non­
applicator
adults
and
children
of
various
age
from
the
biomonitoring
study.
In
most
cases,
the
results
are
again
within
a
factor
of
5
or
so
indicating
good
basic
agreement
between
the
two
approaches.
It
should
also
be
pointed
out
that
on
or
near
the
day
of
application
that
body
burden
estimates
from
the
deterministic
approaches
generally
exceed
those
from
the
biological
monitoring
study
supporting
the
conservative
(
screening
level)
nature
of
the
assessment
approaches.
There
was
a
significant
level
of
discussion
in
this
document
concerning
the
methods
used
to
calculate
absorbed
carbaryl
dose
estimates
from
the
biological
monitoring
study.
In
fact,
three
distinct
options
were
considered
that
included
Bayer's
approach
based
on
using
single
day
values
and
not
correcting
them
for
mass
balance.
The
others
included
correcting
single
day
values
for
mass
balance
and
adding
daily
values
together
to
get
total
dose
estimates.
As
discussed
previously,
the
Agency
opted
to
recommend
the
use
of
total
dose
estimates
for
regulatory
purposes
but
did
an
evaluation
that
compared
that
approach
to
the
values
that
would
be
anticipated
if
daily
estimates
were
corrected
for
mass
balance.
Essentially,
the
results
show
that
there
is
little
or
no
difference
between
the
use
of
total
dose
estimates
(
i.
e.,
adding
over
days)
and
adjusting
single
day
estimates
for
mass
balance
as
would
be
anticipated.
In
7
Pierce
JP
et
al
(
1989).
Tobacco
Use
in
1986
­
Methods
and
Basic
Tabulations
from
Adult
Use
of
Tobacco
Survey.
U.
S.
Department
of
Health
and
Human
Services
Publication
Number
OM90­
2004.
Office
on
Smoking
and
Health,
Rockville,
Maryland.

84
fact,
the
average
difference
between
the
two
methods
was
about
10
to
12
percent.
Another
analysis
which
was
completed
compared
the
results
of
the
biomonitoring
study
with
other
recognizable
population­
based
biological
monitoring
studies
identified
in
the
scientific
literature
(
i.
e.,
various
publications
related
to
NHANES
&
NHEXAS).
For
both
adults
and
children
the
biological
monitoring
data
representing
post­
application
exposures
are
within
2
orders
of
magnitude
of
each
other.
Differences
are
greatest
for
children
and
applicator
adults
after
an
application
because
they
have
recently
been
exposed
and
the
population­
based
monitoring
results
likely
represent
something
closer
to
background
levels
from
the
diet
and
drinking
water.
Agreement
between
the
pre­
exposure
samples
and
the
population­
based
studies
is
better
(
i.
e.,
within
a
factor
of
3
or
so
in
most
cases).
[
Note:
Bayer
arrived
at
essentially
the
same
conclusion.]

In
summary,
the
biological
monitoring
study
is
very
useful
in
that
it
can
be
used
to
evaluate
the
range
of
exposures
that
are
expected
in
a
treated
residential
environment.
The
data
also
support
the
deterministic
assessments
which
have
been
completed
for
carbaryl
as
body
burden
values
calculated
in
those
assessments
are
similar
to
the
biological
monitoring
data.
The
population
which
was
monitored
also
resembles
the
general
population
as
there
is
good
agreement
between
the
pre­
exposure
dose
values
and
general
population
monitoring
data
available
from
NHANES
and
NHEXAS.

4.4.6
Exposure
From
The
Use
of
Tobacco
Noncancer
risks
from
carbaryl
residues
contained
in
tobacco
products
have
been
calculated
based
on
a
pyrolysis
study
in
tobacco.
In
assessing
exposure
through
use
of
tobacco,
HED
has
assumed
that
the
greatest
exposure
to
carbaryl
would
come
from
cigarettes.
Further,
HED
has
assumed
that
the
average
U.
S.
smoker
smokes
15
cigarettes
per
day.
7
Based
on
a
pyrolysis
study
submitted
by
the
registrant,
residues
of
carbaryl
total
approximately
44.58
ppm
in
combined
side­
stream
and
main­
stream
tobacco
smoke
(
Memorandum
from
Thurston
Morton
dated
September
29,
1998,
D230407).
Since
this
is
a
composited
sample
of
main­
stream
and
side­
stream
smoke,
it
greatly
exaggerates
the
actual
exposure
to
the
smoker,
whose
primary
route
of
exposure
is
via
main­
stream
smoke.
HED
further
assumes
that
100
percent
of
that
inhaled
is
absorbed
(
i.
e.,
that
none
of
the
residue
is
exhaled
along
with
the
smoke).
These
assumptions
result
in
an
extreme
overestimate
of
actual
likely
exposure.
With
the
assumptions
regarding
residue
levels
and
smoking
frequency,
and
assuming
an
average
body
weight
of
70
kg,
HED
estimated
that
exposure
to
carbaryl
will
not
exceed
0.0096
mg/
kg/
day
[
44.58
:
g/
g
cigarette
×
1
g/
cigarette
×
15
cigarettes/
day
×
1
mg/
1000
:
g
÷
70
kg
body
weight
=
0.0096
mg/
kg/
day].

The
short­
term
inhalation
NOAEL
is
1
mg/
kg/
day
and
is
based
on
an
developmental
neurotoxicity
study
in
the
rat.
Based
on
the
inhalation
NOAEL,
the
short­
term
MOE
for
carbaryl
exposure
from
the
use
of
tobacco
is
estimated
to
be
104
which
should
be
considered
along
with
the
conservative
basis
of
the
assessment.
The
residential
target
MOE
is
100.
The
Agency
has
not
examined
intermediate­
or
long­
term
exposure
to
carbaryl
(
including
cancer)
via
tobacco
due
to
the
severity
and
quantity
of
health
effects
associated
with
the
use
of
tobacco
products
which
would
likely
make
any
85
additional
effects
from
carbaryl
exposure
indistinguishable
from
those
associated
with
tobacco
use.

4.4.7
Other
Residential
Exposures
This
assessment
for
carbaryl
reflects
the
Agency's
current
approaches
for
completing
residential
exposure
assessments
based
on
the
guidance
provided
in
the
Draft:
Series
875­
Occupational
and
Residential
Exposure
Test
Guidelines,
Group
B­
Postapplication
Exposure
Monitoring
Test
Guidelines,
the
Draft:
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessment,
and
the
Overview
of
Issues
Related
to
the
Standard
Operating
Procedures
for
Residential
Exposure
Assessment
presented
at
the
September
1999
meeting
of
the
FIFRA
Scientific
Advisory
Panel
(
SAP).
The
Agency
is,
however,
currently
in
the
process
of
revising
its
guidance
for
completing
these
types
of
assessments.
Modifications
to
this
assessment
shall
be
incorporated
as
updated
guidance
becomes
available.
This
will
potentially
include
expanding
the
scope
of
the
residential
exposure
assessments
by
developing
guidance
for
characterizing
exposures
from
other
sources
already
not
addressed
such
as
from
spray
drift;
residential
residue
track­
in;
exposures
to
farmworker
children;
and
exposures
to
children
in
schools.

5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
Based
on
the
requirements
of
FQPA,
aggregate
risk
assessments
which
consider
combined
exposure
from
food,
drinking
water,
and
residential
uses
have
been
completed.
Different
types
of
aggregate
assessments
are
required
depending
upon
the
use
patterns
of
a
chemical,
the
types
of
toxic
effects
associated
with
it,
and
the
anticipated
durations
of
exposure.
This
is
to
ensure
that
the
Agency
considers
all
manner
of
possible
exposures
in
the
population
that
could
occur
from
carbaryl
use.
As
a
result,
a
series
of
aggregate
calculations
have
been
completed
for
carbaryl.
Section
5.1:
Calculation
of
Aggregate
Risks
and
DWLOCs
describes
how
aggregate
calculations
were
completed
for
each
duration
of
exposure
using
standard
Agency
techniques.
Section
5.2:
Acute
Aggregate
Risks
presents
the
results
for
the
acute
assessment
(
dietary
and
drinking
water
only).
Section
5.3:
Chronic
Aggregate
Risks
and
DWLOCs
presents
the
results
for
the
chronic
assessment
(
dietary
and
drinking
water).
Section
5.4:
Short­
term
Aggregate
Risks
and
DWLOCs
presents
the
results
for
the
short­
term
assessment
which
includes
dietary
intake
(
food
and
drinking
water)
and
residential
exposures.
Section
5.5:
Intermediateterm
Aggregate
Risks
and
DWLOCs
presents
the
results
for
the
intermediate­
term
assessment
which
includes
dietary
intake
(
food
and
drinking
water)
and
residential
exposures.
Section
5.6:
Aggregate
Cancer
Risks
and
DWLOCs
presents
the
results
for
the
cancer
assessment
that
includes
dietary
intake
and
residential
exposures.
Section
5.7:
Summary
of
Non­
Probabilistic
Aggregate
Risks
provides
an
overview
of
the
aggregate
risk
assessment
results
that
were
completed
using
more
standard
Agency
approaches
for
these
calculations.
[
Note:
The
acute
dietary
assessment
is,
in
effect,
a
probabilistic
assessment
but
was
summarizaed
in
this
section
for
convenience.
The
differentiation
in
this
section
was
made
to
describe
separately
the
submission
from
Bayer
using
CARES
to
assess
exposures
in
the
general
population
and
the
Agency's
review
of
that
submission.]
Section
5.8:
Companion
Probabilistic
Aggregate
Risk
Assessments
describes
the
probabilistic
assessment
submitted
by
Bayer
using
the
CARES
probabilistic
model
and
the
Agency's
review
of
it
to
date.
The
results
of
this
probabilistic
assessment
should
be
considered
in
conjunction
with
the
standard
Agency
approaches
and
the
results
of
the
suburban
resident
biological
monitoring
study.
5.1
Calculation
of
Aggregate
Risks
and
DWLOCs
8
There
are
several
aggregate
risk
guidance
documents
that
address
both
deterministic
and
probabilistic
risk
assessment
approaches.
The
major
science
policy
papers
are
available
at
www.
EPA.
Gov/
pesticides.
The
two
key
documents
used
for
this
assessment
are
1)
Updated
Interim
Guidance
For
Incorporating
Drinking
Water
Exposure
Into
Aggregate
Risk
Assessments
(
Stasikowski,
8/
1/
99)
and
2)
HED
RARC
Format
and
Risk
Characterization
Guidance
(
12/
22/
00).

86
The
Agency
has
developed
several
guidance
documents
describing
the
mathematical
approaches
used
in
calculating
aggregate
risks,
the
theoretical
basis
for
these
calculations,
and
the
interpretation
of
the
Food
Quality
Protection
Act
that
requires
the
Agency
to
complete
these
kinds
of
calculations.
8
The
underlying
approach,
regardless
of
the
calculation
type,
is
the
same.
The
overall,
allowable
risks
associated
with
an
individual
chemical
are
first
determined
by
its
hazard
database
and
its
associated
uncertainty
factors
or
negligible
risks
if
the
concern
is
cancer
(
i.
e.,
an
exposure
limit
is
defined).
Once
limits
have
been
defined,
contributions
from
different
sources
are
then
added
to
obtain
aggregate
exposures
(
diet­
food
only
and
residential)
which
are
compared
to
the
exposure
limit
to
see
if
it
has
been
exceeded
which
would
indicate
a
risk
concern.
If
it
has
not
been
exceeded,
what
remains
under
the
aggregate
exposure
limit
is
attributed
to
drinking
water
by
convention.
This
remainder
is
referred
to
as
a
DWLOC
(
Drinking
Water
Levels
of
Concern).
To
ascertain
whether
or
not
there
is
a
risk
concern
due
from
drinking
water
exposure,
an
estimated
environmental
concentration
(
EEC)
for
water
is
calculated.
If
the
EEC
exceeds
the
DWLOC
(
i.
e.,
what
is
allowable
under
the
risk
ceiling)
then
there
is
a
risk
concern.

The
acute
aggregate
risk
assessment
for
carbaryl,
however,
is
the
exception
to
the
DWLOC
approach.
It
is
groundbreaking
from
a
methodological
perspective
in
that
it
is
one
of
the
first
true
probabilistic
aggregate
assessments
completed
by
the
Agency.
This
analysis
incorporated
distributions
of
water
concentrations
calculated
using
PRZM/
EXAMs
into
DEEM/
FCID
only
for
the
acute
assessment
instead
of
using
the
DWLOC
approach.
A
distribution
of
water
concentrations
was
selected
for
Florida
citrus
because
it
has
the
highest
EECs
associated
with
it.
The
results
from
this
analysis
was
also
compared
to
DEEM/
FCID
results
without
water
in
order
to
determine
how
much
water
contributes
to
overall
exposure.
In
essence,
in
this
assessment
water
was
treated
like
any
other
commodity
in
the
calculations
and
interpretation
of
the
results.

For
all
other
assessments,
when
aggregate
exposures
(
residential
and/
or
diet)
exceed
exposure
limits,
DWLOCs
are
not
calculated.
If
exposures
do
not,
on
the
other
hand,
exceed
those
limits,
DWLOCs
are
calculated.
This
can
be
a
very
simple
calculation
such
as
subtracting
chronic
food
exposures
from
the
cPAD
or
chronic
food
intake
and
residential
LADD
estimates
from
the
Q1*
in
a
cancer
calculation.
In
some
cases
it
can
be
more
complex
such
as
for
the
short­
term
assessment
that
required
using
the
1/
MOE
approach
described
above
in
Section
4.4.2.1:
Residential
Handler
Noncancer
Risks
where
water
and
dietary
MOEs
are
added
to
the
equation
and
compared
to
the
target
MOE.
The
equation
was
then
solved
for
the
water
MOE
which
was
in
turn
used
to
calculate
the
maximum
drinking
water
exposure
using
the
short­
term
oral
NOAEL.
Maximum
allowable
drinking
water
exposure
levels
were
then
used
to
calculate
concentrations
in
water
based
on
standard
daily
consumption
estimates
and
body
weight
factors
for
different
subpopulations.
Adults
were
assumed
to
intake
2
liters
of
water
per
day
while
small
children
and
infants
were
assumed
to
intake
1
liter
of
water
per
day.
Standard
body
weights
were
also
used
(
i.
e.,
10
kg
for
small
children,
60
kg
for
adult
females,
and
70
kg
for
other
adult
87
scenarios).
The
equation
used
to
calculate
the
DWLOCs
is
presented
below:

DWLOC(
µ
g/
L)
=
[
water
exposure
(
mg/
kg
bw/
day)
x
body
weight
(
kg)]
[
water
consumption
(
L)
x
10­
3
mg/
µ
g]

[
Note:
Water
exposure,
body
weight,
and
consumption
inputs
are
specific
to
certain
exposure
durations,
toxicity
concerns,
and
populations
so
they
will
vary
from
assessment
to
assessment.]

DWLOCs
were
then
were
compared
to
the
Estimated
Environmental
Concentrations
(
EECs)
as
defined
by
the
Environmental
Fate
and
Effects
Division
(
Section
4.3.3:
Modeling
EECs,
Table
10).
Drinking
water
sources
can
include
surface
water
or
groundwater.
EEC
values
are
available
for
both
sources.
For
surface
water,
computer
modeling
with
the
EPA
PRZM3.12
and
EXAMS
2.98.04
programs
were
used
to
estimate
the
concentration
of
carbaryl
in
surface
water.
Index
reservoir
scenarios
corrected
for
Percent
Cropped
Area
(
PCA)
for
representative
crops
were
used.
The
maximum
calculated
acute
and
chronic
surface
water
EECs
(
316
ppb
and
14.2
ppb,
respectively)
resulted
from
use
on
citrus
in
Florida.
In
this
case,
the
results
for
Florida
provided
the
highest
estimates;
however,
in
Florida
the
majority
of
drinking
water
is
derived
from
groundwater
(>
90%)
so
high
surface
water
concentrations
do
not
necessarily
indicate
high
exposure.
As
a
result,
both
Florida
and
the
results
for
Pennsylvania
apples
and
Ohio
sweetcorn
have
been
considered
(
PA
apple
acute
EEC
=
62.9
ppb
and
OH
sweetcorn
chronic
EEC
=
5.53
ppb).
SCI­
GROW
2.2
is
the
model
which
was
used
to
calculate
groundwater
EECs.
Carbaryl
chemical
properties
are
outside
the
range
of
values
for
which
SCI­
GROW
was
developed
(
i.
e.,
aerobic
metabolism
is
faster
and
its
partition
coefficient
is
larger
which
equates
to
less
leaching
than
the
reference
compounds
­
both
factors
indicate
carbaryl
degrades
faster
than
the
reference
chemicals).
As
a
result,
SCI­
GROW
estimates
for
groundwater
EECs
may
not
predict
with
complete
accuracy,
maximum
levels
because
the
concentrations
calculated
are
90
day
averages.
It
is
possible;
therefore,
that
groundwater
concentration
peaks
could
not
be
identified.
Groundwater
levels
are
anticipated,
however,
to
be
more
stable
than
surface
water
concentrations.
The
groundwater
EEC
used
for
all
calculations
was
0.8
ppb.

If
the
EEC
is
less
than
the
corresponding
DWLOC
then
the
Agency
has
no
concerns
for
aggregate
risks
for
the
scenario.
If
EECs
exceed
the
DWLOC
then
aggregate
risks
are
of
concern.
For
carbaryl,
there
were
many
residential
scenarios
where
the
combined
MOEs
(
i.
e.,
combinations
of
inhalation,
dermal
and
nondietary
ingestion
as
appropriate)
exceed
the
Agency's
risk
targets
making
the
calculation
of
DWLOCs
and
aggregate
risks
for
those
scenarios
inappropriate
because
exposure
limits
have
already
been
exceeded.
Keeping
this
in
mind,
the
Agency
completed
DWLOC
and
aggregate
risk
calculations,
however,
for
illustrative
purposes
using
a
number
of
representative
exposure
scenarios
where
the
residential
and
dietary
risk
estimates
did
not
already
exceed
the
Agency's
level
of
concern.
For
example,
short­
term
assessments
where
residential
handler
risks
weren't
already
of
concern
were
completed.
The
Agency
also
specifically
selected
some
scenarios
because
they
represent
major
residential
uses
(
e.
g.,
garden
dusts)
or
specialized
low
exposure
scenarios
(
e.
g.,
mosquito
control).
88
The
Agency
approach
for
calculating
aggregate
risks
using
different
sources
of
data
to
create
different
exposure
scenarios
for
illustrative
purposes
is
consistent
with
Agency­
wide
guidance
for
exposure
assessment
and
risk
characterization
(
e.
g.,
consideration
of
PDP
and
carbamate
market
basket
survey,
various
water
scenarios,
and
selected
residential
scenarios).
The
Agency
takes
this
approach
to
allow
for
more
informed
risk
management
decisions
that
consider
as
much
available
data
as
possible
along
with
the
uncertainties
associated
with
those
data.

5.2
Acute
Aggregate
Risks
The
results
of
the
acute
aggregate
risk
assessment
are
presented
below
in
Table
22
(
i.
e.,
residential
is
not
considered,
just
food
and
water).
These
calculations
are
not
based
on
the
use
of
the
Carbamate
Market
Basket
Survey
(
CMBS)
except
for
citrus
and
bananas.
This
was
done
because
the
acute
dietary
analysis
determined
that
use
of
the
CMBS
does
not
significantly
impact
the
overall
result.
Additionally,
as
indicated
above,
this
analysis
is
groundbreaking
in
that
it
also
included
water
residue
concentration
distributions
calculated
with
PRZM/
EXAMs.
The
results
indicate
that
inclusion
of
water
in
the
analysis
provided
similar
results
to
the
dietary
assessment.
In
essence,
the
addition
of
water
had
no
impact
on
the
results.
The
analyses
show
that
the
highest
exposed
population
subgroup,
children
(
1­
2
years
old)
consumed
93%
of
the
aPAD.
[
Note:
Because
the
result
is
1%
lower
than
the
acute
dietary
assessment
at
94%
of
the
aPAD
consumed
it
appears
that
inclusion
of
water
into
the
acute
assessment
lowers
the
risk.
This
is
an
artifact
of
the
DEEM­
FCID
model
that
can
occur
due
to
binning
a
very
large
number
of
exposure
records
and
rounding
small
numbers.
These
small
decreases
are
considered
insignificant.]
The
acute
dietary
exposure
estimate
for
the
general
U.
S.
population
was
43%
of
the
aPAD.

Table
22.
Results
of
Acute
Probabilistic
Aggregate
Analysis
Population
Subgroup
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.01
0.000471
5
0.001296
13
0.004297
43
All
Infants
(<
1
year
old)
0.01
0.000764
8
0.002780
28
0.006766
68
Children
1­
2
years
old
0.01
0.001887
19
0.003510
35
0.009257
93
Children
3­
5
years
old
0.01
0.001228
12
0.002423
24
0.008058
81
Children
6­
12
years
old
0.01
0.000741
7
0.001448
14
0.005506
55
Youth
13­
19
years
old
0.01
0.000368
4
0.000831
8
0.003237
32
Adults
20­
49
years
old
0.01
0.000300
3
0.000755
8
0.002940
29
Females
13­
49
years
old
0.01
0.000284
3
0.000754
8
0.003257
33
Adults
50+
years
old
0.01
0.000286
3
0.000789
8
0.003032
30
(
Market
Basket
Survey
Data
Not
Included
except
for
citrus
and
bananas)
89
5.3
Chronic
Aggregate
Risks
and
DWLOCs
The
results
of
the
chronic
aggregate
risk
assessment
are
presented
below
in
Table
23.
Chronic
aggregate
risks
were
not
of
concern
for
any
subpopulation
regardless
of
the
source
of
drinking
water,
even
considering
the
Florida
surface
water
EECs.

Table
23:
Chronic
DWLOC
Calculations
Population
Subgroup
cPAD
(
mg/
kg/
day)
Chronic
Food
Exposure
(
mg/
kg/
day)
Max.
Chronic
Water
Exposure
(
mg/
kg/
day)
Chronic
DWLOC
(
ug/
L
or
ppb)
EECs
Surface
Water
(
all
PRZM/
EXMS)
Ground
Water
(
SciGrow)
(
ppb)
FL
Citrus
(
ppb)
OH
Sweet
Corn
(
ppb)
All
Commodities
Using
1994­
1998
CFSII
Consumption
Data
General
Population
0.010000
0.000024
0.009976
349.2
14.2
5.53
0.8
All
Infants
0.010000
0.000055
0.009945
99.5
14.2
5.53
0.8
Children
(
1­
2
yrs)
0.010000
0.000076
0.009924
99.2
14.2
5.53
0.8
Children
(
3­
5
yrs)
0.010000
0.000054
0.009946
99.5
14.2
5.53
0.8
Children
(
6­
12
yrs)
0.010000
0.000029
0.009971
99.7
14.2
5.53
0.8
Females
(
13­
49
yrs)
0.010000
0.000018
0.009982
299.5
14.2
5.53
0.8
Youth
(
13­
19
yrs)
0.010000
0.000015
0.009985
349.5
14.2
5.53
0.8
Adults
(
20­
49
yrs)
0.010000
0.000020
0.009980
349.3
14.2
5.53
0.8
Seniors
(
50+
yrs)
0.010000
0.000021
0.009979
349.3
14.2
5.53
0.8
There
is
one
chronic
residential
exposure
scenario
associated
with
the
use
of
pet
collars
where
the
MOEs
for
children
are
of
concern
calculated
with
Agency
inputs.
As
such,
exposure
from
pet
collars
was
not
included
in
the
chronic
DWLOC
calculations
because
of
the
risk
concerns
for
this
scenario
and
to
illustrate
chronic,
aggregate
risks
for
all
others
who
are
not
exposed
to
collars
which
represents
the
vast
majority
of
the
population.

5.4
Short­
term
Aggregate
Risks
and
DWLOCs
The
results
of
the
short­
term
aggregate
risk
assessment
are
presented
below
in
Table
24.
The
exposure
scenarios
which
were
considered
in
this
assessment
represent
a
broad
range
of
carbaryl
uses.
The
only
scenarios
for
toddlers
that
were
included
were
for
the
mosquito
control,
pet
collar,
and
oyster
bed
uses.
The
Agency
has
risk
concerns
for
all
other
scenarios
that
were
addressed
for
toddlers
based
on
residential
exposures
alone
including
uses
on
turf
and
non­
collar
uses
on
pets
(
see
Section
4.4.3.1:
Residential
Postapplication
Exposure
and
Noncancer
Risks).
[
Note:
Risks
associated
with
pet
collars
should
also
be
considered
in
context
with
the
marginal
quality
of
the
study
upon
which
they
are
based.]
In
the
residential
assessment,
youth
(
ages
10
to
12)
were
also
considered
in
home
garden
scenarios.
The
risk
estimates
for
these
children
are
similar
to
that
for
adults
so
aggregate
risks
were
calculated
only
for
adults
with
the
stipulation
that
the
results
represent
both
populations
(
i.
e.,
risks
are
actually
slightly
worse
for
adults).
For
adults,
the
following
postapplication
exposures
were
considered:
after
mosquito
control
(
doing
heavy
yardwork/
lawncare);
golfing;
gardening
(
highest
exposure
activity
­
tree
fruit
harvest);
and
oyster
harvesting.
Adults
doing
heavy
lawncare
tasks
after
normal
applications
to
turf
were
of
concern
for
residential
exposure
alone
so
they
were
not
considered
in
the
aggregate
assessment.
Additionally,
several
aggregate
assessments
for
homeowner
handlers
(
most
at
average
application
rates)
were
completed
based
on
application
of
dusts
(
gardens
and
pets):
hose­
end
sprayer;
liquid
spray
spot
lawn
treatments;
and
broadcast
application
of
granulars
to
lawns.
The
handler
scenarios
are
numbered
and
these
correspond
to
the
residential
risk
assessment
scenario
numbers.
Risks
for
these
handler
scenarios
at
higher
application
rates
(
e.
g.,
label
maximums)
were
of
concern
for
residential
exposure
alone
so
they
90
were
not
considered
in
the
aggregate
assessment.
All
calculations
for
adults
were
completed
for
both
women
and
then
for
all
adults.
Results
were
similar
for
both
populations.

For
the
selected
scenarios,
surface
water
EECs
based
on
either
Florida
citrus
or
Ohio
sweetcorn
are
not
of
concern.
Additionally,
for
the
selected
scenarios
groundwater
EECs
are
not
of
concern.
To
reiterate,
the
scenarios
selected
for
analysis
in
the
short­
term
aggregate
assessment
represent
those
where
risks
were
not
of
concern
to
the
Agency
for
illustrative
purposes
and
to
address
some
potential
public
health
uses
for
carbaryl.
There
are
many
residential
scenarios
where
risks
are
of
concern
to
the
Agency
as
described
above
(
see
Section
4.4
above).

Table
24:
Short­
term
Aggregate
Risk
and
DWLOC
Calculations
Using
1994­
1998
CFSII
Consumption
Data
Population
Subgroup
Target
Agg.
MOE
Food
MOE
Nondietary
Ing.
MOE
Dermal
MOE
Inhal.
MOE
Aggregat
e
MOE
Water
MOE
Allowable
Water
Exposure
(
mg/
kg/
day)
DWLOC
(
ug/
L
or
ppb)
EECs
Surface
Water
(
all
PRZM/
EXMS)
Ground
Water
(
SciGrow
)

(
ppb)
FL
Citrus
(
ppb)
OH
Sweetcor
n
(
ppb)
Postapplication
Children
Children
(
1­
6
yrs)
Aerial
Mosquito
Day
0
100
18519
562
2211
NA
437
130
0.007713
115.7
14.2
5.53
0.8
Children
(
1­
6
yrs)
Oyster
Bed
Day
0
100
18519
51681
68909
NA
11382
101
0.009912
148.7
14.2
5.53
0.8
Children
(
1­
6
yrs)
Pet
Collar
Day
0
100
18519
3590
383
NA
340
142
0.007056
105.8
14.2
5.53
0.8
Postapplication
Adult
Males
Adult
Aerial
Mosquito
Day
0­
Lawncare
100
50000
NA
3700
NA
3445
103
0.009710
339.8
14.2
5.53
0.8
Adult
Golfing
Day
0­
Max
Rate
100
50000
NA
624
NA
616
119
0.008377
293.2
14.2
5.53
0.8
Adult
Garden
Day
0­
High
Expo.
100
50000
NA
579
NA
572
121
0.008253
288.9
14.2
5.53
0.8
Adult
Oyster
Bed
Use
Day
0,
Swim
100
50000
30815
10856944
NA
42725
100
0.009977
349.2
14.2
5.53
0.8
Adult
Male
Consumer
Product
Handlers
Adult
Scen.
#
2
Garden
Dust
Avg
Rate
100
50000
NA
120
1019
107
1553
0.000644
22.5
14.2
5.53
0.8
Adult
Scen
#
3
Gard.
Hose
End,
Avg
Rate
100
50000
NA
158
134615
158
273
0.003659
128.1
14.2
5.53
0.8
Adult
Scen
#
8
Lawn
Spot­
Liquids
100
50000
NA
509
17500
490
126
0.007959
278.6
14.2
5.53
0.8
Adult
Scen
#
9
Dusting
Dog
Avg
Rate
100
50000
NA
163
1077
141
342
0.002924
102.3
14.2
5.53
0.8
Adult/
Scen
#
12
Lawn
Broadcast
Granular
100
50000
NA
490
18315
473
127
0.007885
276.0
14.2
5.53
0.8
Postapplication
Adult
Females
Adult
Female
Aerial
Mosquito
Day
0­
Lawncare
100
55556
NA
3700
NA
3469
103
0.009712
291.4
14.2
5.53
0.8
Adult
Female
Golfing
Day
0­
Max
Rate
100
55556
NA
624
NA
617
119
0.008379
251.4
14.2
5.53
0.8
Adult
Female
Garden
Day
0­
High
Expo.
100
55556
NA
579
NA
573
121
0.008255
247.6
14.2
5.53
0.8
Adult
Female
Oyster
Bed
Use
Day
0,
Swim
100
55556
30815
10856944
NA
46717
100
0.009979
299.4
14.2
5.53
0.8
Adult
Female
Consumer
Product
Handlers
Adult
Female
Scen.
#
2
Garden
Dust
Avg
Rate
100
55556
NA
120
1019
107
1548
0.000646
19.4
14.2
5.53
0.8
Adult
Female
Scen
#
3
Gard.
Hose
End,
Avg
Rate
100
55556
NA
158
134615
158
273
0.003661
109.8
14.2
5.53
0.8
Adult
Female
Scen
#
8
Lawn
Spot­
Liquids
100
55556
NA
509
17500
490
126
0.007961
238.8
14.2
5.53
0.8
Adult
Female
Scen
#
9
Dusting
Dog
Avg
Rate
100
55556
NA
163
1077
141
342
0.002926
87.8
14.2
5.53
0.8
Adult
Female
Scen
#
12
Lawn
Broadcast
Granular
100
55556
NA
490
18315
473
127
0.007887
236.6
14.2
5.53
0.8
5.5
Intermediate­
term
Aggregate
Risks
and
DWLOCs
91
Separate
intermediate­
term
aggregate
risk
and
DWLOC
calculations
were
not
completed
for
carbaryl
because
the
short­
term
aggregate
risk
estimates
essentially
represent
the
same
results
since
the
hazard
inputs
are
numerically
identical.
The
only
major
differences
would
be
the
postapplication
results
where,
instead
of
a
single
day
exposure
estimate,
the
exposures
represent
a
30
day
average.
The
DWLOCs
were
not
of
concern
for
the
short­
term
exposure
scenarios
and
they
would
not
be
expected
to
be
of
concern
for
the
intermediate­
term
scenarios
since
the
exposures
would
be
lowered
because
an
average
exposure
was
used
instead
of
a
single
day,
higher
exposure
estimate.

5.6
Aggregate
Cancer
Risks
and
DWLOCs
The
results
of
the
aggregate
cancer
risk
assessment
are
presented
below
in
Table
25.
The
exposure
scenarios
which
were
considered
in
this
assessment
represent
a
broad
range
of
carbaryl
uses.
The
same
scenarios
for
adults
were
considered
as
in
the
short­
term
assessment
described
above
in
Section
5.4:
Short­
term
Aggregate
Risks
and
DWLOCs.
Aggregate
cancer
risks
were
not
of
concern
for
any
subpopulation
regardless
of
the
source
of
drinking
water.

Table
25:
Aggregate
Cancer
Risk
and
DWLOC
Calculations
Using
1994­
1998
CFSII
Consumption
Data
Population
Subgroup
Q1*
(
mg/
kg/
day)­
1
Negligible
Risk
Level
Target
Maximum
Exposure
(
mg/
kg/
day)
Chronic
Food
Exposure
(
mg/
kg/
day)
Residential
Exposure
LADD
(
mg/
kg/
day)
Aggregate
Cancer
Risk
(
Food
&
Residential)
Maximum
Water
Exposure
(
mg/
kg/
day)
DWLOC
(
ug/
L
or
ppb)
EECs
Surface
Water
(
all
PRZM/
EXMS)
Ground
Water
(
SciGrow)
(
ppb)
FL
Citrus
(
ppb)
OH
Sweetcorn
(
ppb)

Postapplication
Adult
Males
Adult
Male/
Aerial
Mosquito
Day
0­
Lawncare
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
6.70e­
07
1.81e­
08
0.001122
39.3
14.2
5.53
0.8
Adult
Male/
Golfing
Day
0­
Max
Rate
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
4.00e­
06
2.10e­
08
0.001119
39.2
14.2
5.53
0.8
Adult
Male/
Garden
Day
0­
High
Expo.
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
8.57e­
06
2.50e­
08
0.001114
39.0
14.2
5.53
0.8
Adult
Male/
Oyster
Bed
Use
Day
0,
Swim
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
1.00e­
08
1.75e­
08
0.001123
39.3
14.2
5.53
0.8
Adult
Male
Consumer
Product
Handlers
Adult
Male/#
2
Garden
Dust
Avg
Rate
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
4.34e­
05
5.55e­
08
0.001079
37.8
14.2
5.53
0.8
Adult
Male/#
3
Garden
Hose
End,
Avg
Rate
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
3.14e­
05
4.50e­
08
0.001091
38.2
14.2
5.53
0.8
Adult
Male/#
8
Lawn
Spot­
Liquids
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
9.87e­
06
2.61e­
08
0.001113
39.0
14.2
5.53
0.8
Adult
Male/#
9
Dusting
Dog
Avg
Rate
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
3.22e­
05
4.57e­
08
0.001091
38.2
14.2
5.53
0.8
Adult
Male/#
12
Lawn
Broadcast
Granular
8.75x10­
4
1.0x10­­
6
0.001143
0.000020
1.03e­
05
2.65e­
08
0.001113
38.9
14.2
5.53
0.8
Postapplication
Adult
Females
Adult
Female/
Aerial
Mosquito
Day
0­
Lawncare
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
6.70e­
07
1.63e­
08
0.001124
33.7
14.2
5.53
0.8
Adult
Female/
Golfing
Day
0­
Max
Rate
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
4.00e­
06
1.93e­
08
0.001121
33.6
14.2
5.53
0.8
Adult
Female/
Garden
Day
0­
High
Expo.
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
8.57e­
06
2.33e­
08
0.001116
33.5
14.2
5.53
0.8
Adult
Female/
Oyster
Bed
Use
Day
0,
Swim
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
1.00e­
08
1.58e­
08
0.001125
33.7
14.2
5.53
0.8
Table
25:
Aggregate
Cancer
Risk
and
DWLOC
Calculations
Using
1994­
1998
CFSII
Consumption
Data
Population
Subgroup
Q1*
(
mg/
kg/
day)­
1
Negligible
Risk
Level
Target
Maximum
Exposure
(
mg/
kg/
day)
Chronic
Food
Exposure
(
mg/
kg/
day)
Residential
Exposure
LADD
(
mg/
kg/
day)
Aggregate
Cancer
Risk
(
Food
&
Residential)
Maximum
Water
Exposure
(
mg/
kg/
day)
DWLOC
(
ug/
L
or
ppb)
EECs
Surface
Water
(
all
PRZM/
EXMS)
Ground
Water
(
SciGrow)
(
ppb)
FL
Citrus
(
ppb)
OH
Sweetcorn
(
ppb)

92
Adult
Female
Consumer
Product
Handlers
Adult
Female/#
2
Garden
Dust
Avg
Rate
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
4.34e­
05
5.38e­
08
0.001081
32.4
14.2
5.53
0.8
Adult
Female/#
3
Garden
Hose
End,
Avg
Rate
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
3.14e­
05
4.33e­
08
0.001093
32.8
14.2
5.53
0.8
Adult
Female/#
8
Lawn
Spot­
Liquids
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
9.87e­
06
2.44e­
08
0.001115
33.4
14.2
5.53
0.8
Adult
Female/#
9
Dusting
Dog
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
3.22e­
05
4.40e­
08
0.001093
32.8
14.2
5.53
0.8
Adult
Female/#
12
Lawn
Broadcast
Granular
8.75x10­
4
1.0x10­­
6
0.001143
0.000018
1.03e­
05
2.47e­
08
0.001115
33.4
14.2
5.53
0.8
5.7
Summary
of
Non­
Probabilistic
Aggregate
Risks
The
non­
probabilistic
aggregate
assessments
for
carbaryl
are
groundbreaking
in
that
they
rely
on
the
Agency's
standing
policies
for
these
assessments
but
it
also
includes
the
first
acute
aggregate
assessment
where
a
water
concentration
distribution
from
PRZM/
EXAMS
has
been
directly
integrated
into
DEEM/
FCID.
In
essence,
the
data
for
water
were
treated
as
the
data
would
be
for
any
food
commodity.
As
such,
DWLOCs
have
been
calculated
for
all
scenarios
except
the
acute
assessment.
In
fact,
the
results
for
the
acute
assessment
have
been
presented
like
a
food
only
assessment
using
the
99.9th
%
tile
as
level
of
concern.
Results
for
additional
percentiles
of
exposure
have
also
been
presented
to
allow
for
a
more
informed
risk
management
decision.

The
remaining
assessments
were
completed
using
the
Agency's
standard
DWLOC/
EEC
approach
(
i.
e.,
chronic,
short­/
intermediate­
term,
and
cancer).
It
should
be
noted,
however,
that
residential
risks
alone
were
of
concern
which
in
most
risk
assessments
would
preclude
the
calculation
of
DWLOCs.
However,
to
allow
for
a
more
informed
risk
management
decision,
a
few
residential
scenarios
were
selected
to
calculate
illustrative
aggregate
risk
estimates.
In
most
cases,
these
were
estimates
based
on
average
application
rates
and
not
label
maximum
rates.
Other
scenarios
were
selected
that
had
public
health
concerns
associated
with
them.
There
were
many
residential
scenarios
where
the
Agency
had
risk
concerns
alone
(
see
Section
4.4
above
for
further
information).
Bayer
has
also
recently
submitted
a
probabilistic
aggregate
assessment
which
should
be
considered
in
conjunction
with
this
assessment.
It
is
also
recommended
that
the
results
of
the
suburban
resident
biological
monitoring
study
be
considered
because
the
exposure
measurements
from
that
study
essentially
represent
aggregate
estimates
even
though
it
is
clear
that
residential
uses
account
for
the
largest
portion
of
the
overall
body
burdens
(
i.
e.,
homeowner
products
were
used
in
every
case).

The
results
of
the
acute
aggregate
assessment
indicate
that
inclusion
of
water
in
the
analysis
provided
similar
results
to
the
dietary
assessment.
In
essence,
the
addition
of
water
had
no
impact
on
the
results.
The
analyses
show
that
the
highest
exposed
population
subgroup,
children
(
1­
2
years
old)
consumed
93%
of
the
aPAD.
The
acute
dietary
exposure
estimate
for
the
general
U.
S.
population
was
43%
of
the
aPAD.
In
the
short­
term
assessment,
the
Agency
selected
representative
scenarios
where
residential
risks
alone
were
not
of
concern
including
mosquito
control,
oyster
harvesting,
golfing,
garden
harvest,
and
several
handler.
Regardless
of
the
drinking
water
source,
aggregate
risks
were
not
of
concern
for
the
selected
scenarios
keeping
in
mind
those
that
were
selected
represented
average
93
application
rates
or
public
health
scenarios
and
the
Agency
has
risk
concerns
for
residential
exposures
alone
for
many
scenarios
at
higher
application
rates.
Separate
intermediate­
term
aggregate
risk
and
DWLOC
calculations
were
not
completed
for
carbaryl
because
the
short­
term
aggregate
risk
estimates
essentially
presented
the
same
results
since
the
hazard
inputs
were
numerically
identical.
The
only
major
differences
would
be
related
to
the
postapplication
residential
exposures
where,
instead
of
a
single
day
exposure
estimate,
the
exposures
represented
a
30
day
average.
Aggregate
chronic
and
cancer
risks
were
not
of
concern
for
any
subpopulation
regardless
of
the
source
of
drinking
water.

5.8
Companion
Probabilistic
Aggregate
Risk
Assessments
Bayer
has
submitted
a
probabilistic
aggregate
assessment
using
the
CARES
model
which
has
been
reviewed
by
the
FIFRA
Science
Advisory
Panel.
The
Agency
has
begun
evaluating
the
inputs
and
analysis
for
the
CARES
assessment.
Because
of
the
late
submission
date
related
to
the
release
of
this
assessment,
this
section
describes
Bayer's
submission
and
the
Agency's
preliminary
analysis
and
review
of
the
submission.
The
Agency
will
develop
separate
document
that
describes
the
inputs
and
results
of
these
efforts
in
more
detail
at
a
later
date
which
will
also
be
considered
in
the
risk
management
decision
making
process.
Given
the
recent
submission
date,
and
the
short
time
for
the
preliminary
evaluation,
it
is
still
too
early
to
draw
any
final
conclusions
about
Bayer's
use
of
the
CARES
model
to
assess
human
health
risks
from
carbaryl
uses.
It
will
take
the
EPA
some
time
to
complete
an
in­
depth
analysis
and
come
to
any
conclusions
about
its
validity.
The
submission
can
be
identified
by
the
following
information:

°
Evaluation
of
Potential
Aggregate
Human
Health
Risks
Associated
with
Agricultural
and
Consumer
Uses
of
Carbaryl;
Authors:
Jeffery
Driver,
Muhilan
Pandian,
John
Ross
of
info
scientific.
com
&
Curt
Lunchick,
Gary
Mihlan,
Jennifer
Phillips
of
Bayer;
Date:
2/
14/
03;
Bayer
Document
Number:
B004240.

In
addition,
EPA
received
the
probabilistic
computer
model,
CARES
version
1.3,
that
was
used
to
calculate
potential
risks
in
the
report
as
well
as
the
data
inputs
for
the
model.
It
should
be
noted
this
included
national
residential
pesticide
use
survey
data
from
the
Residential
Exposure
Joint
Venture
(
REJV)
and
exposure
data
from
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF).
The
REJV
and
ORETF
consider
these
data
proprietary
information.

Bayer's
risk
calculations
for
residential
uses
of
carbaryl
are
based
on
the
risk
to
the
general
population
which
includes
both
exposed
and
non­
exposed
individuals.
The
Agency
is
also
interested
in
the
risk
to
a
sub­
population
of
only
those
individuals
exposed
to
a
residential
carbaryl
use
in
order
to
provide
an
analysis
which
could
be
used
to
compare
to
its
completed
assessments
for
this
population.
These
include
a
deterministic
assessment
based
on
standard
Agency
policy
and
an
analysis
of
Bayer's
suburban
resident
biological
monitoring
study.
As
an
example
of
the
in­
depth
analysis
the
Agency
might
perform
on
the
CARES
model,
EPA
made
a
preliminary
assessment
of
the
potential
risks
to
only
those
3
to
5
year
old
children
in
households
that
used
a
broadcast
treatment
of
carbaryl
on
lawns.
The
Agency
decided
to
look
at
the
exposures
from
the
lawn
use
only
as
well
as
aggregating
the
exposure
from
both
lawn
use
and
dietary
exposures
from
carbaryl
residues
on
food.
Again,
EPA
chose
3
to
5
year
olds
because
this
population
mirrors
that
from
the
deterministic
assessment
and
from
the
biological
94
Figure
2
monitoring
study.
The
Agency
hoped
to
correlate
the
CARES
probabilistic
analysis
with
the
biomonitoring
study
and
deterministic
calculations
to
provide
for
some
validation
of
the
modeling
approach.
It
is
also
useful
for
comparing
how
the
different
calculation
approaches
compare
to
one
another
because
it
provides
results
as
a
distribution
of
exposure.

CARES
uses
a
reference
population
of
100,000
individuals
that
can
be
broken
down
into
sub­
populations.
There
are
4,985
children
in
CARES'
sub­
population
of
3
to
5
year
olds.
Use
information
(
probability
of
application,
frequency
of
application,
application
rates,
etc.)
for
carbaryl
lawn
broadcast
treatments
was
obtained
from
the
REJV
12
month
survey
and
incorporated
into
the
CARES
model.
EPA
chose
to
define
exposure
to
3
to
5
year
olds
as
the
day
of
application
of
carbaryl
to
the
lawn
and
the
three
subsequent
days
after
application.
This
corresponds
to
the
same
time
period
used
in
the
biomonitoring
study
of
carbaryl
lawn
application
and
also
approximates
the
timeframe
when
most
residues
are
available
after
lawn
treatments.
An
analysis
was
also
completed
for
all
days
of
the
year.

Analysis
For
Application
Day
And
3
Days
After:
Figure
2
shows
the
distribution
of
risk
to
3
to
5
year
olds
from
lawn
application
of
carbaryl
during
this
4­
day
period.
The
graph
does
not
include
risk
from
food.
In
the
graph
approximately
57
percent
of
the
exposure
events
have
a
MOE
of
less
than
100
from
the
application
of
carbaryl
to
lawns.
MOE
estimates
from
the
biomonitoring
data
suggest
that
this
is
a
realistic
characterization
of
risk.
EPA's
MOE
central
tendency
estimate
of
43,
and
Bayer's
MOE
central
tendency
estimate
of
221
(
differences
are
due
to
interpretation
of
the
data)
bracket
the
CARES'
MOE
value
at
the
50th
percentile.
The
upper
bound
(
highest
exposed
individuals)
have
an
MOE
of
approximately
10.
This
again
correlates
well
with
the
Agency's
deterministic
risk
estimates
as
well
as
the
highest
MOE
estimate
from
the
biomonitoring
study
(
EPA
MOE
=
4.8,
Bayer
MOE
=
10.2).

Figure
3
shows
the
distribution
of
risk
to
3
to
5
year
olds
from
carbaryl
residues
in
food
during
this
4­
day
period.
That
is,
the
figure
includes
the
same
individuals
and
exposure
days
as
Figure
2
but
looks
at
only
the
food
exposure
they
received
on
the
4
days
after
the
application
carbaryl
to
their
lawns.
The
graph
does
95
Figure
3
Figure
4
not
include
risk
from
the
carbaryl
lawn
application.
In
the
graph,
the
margin
of
exposure
for
food
does
not
exceed
100.
This
is
because
the
probability
of
a
lawn
application
is
low
(
less
than
1%)
and
the
probability
that
a
high
dietary
exposure
corresponding
to
a
concurrent
lawn
application
event
is
also
low.
Therefore,
the
probability
that
a
high
dietary
exposure
would
occur
in
the
four
days
after
application
of
carbaryl
to
the
lawn
is
very
low.

Figure
4
shows
the
distribution
of
the
aggregated
risk
to
3
to
5
year
olds
from
the
application
of
carbaryl
to
the
lawn
and
from
carbaryl
residues
in
food
during
this
4­
day
period.
In
the
graph,
lawn
care
exposures
dominate
the
aggregate
exposure
for
3
to
5
year
olds.
Again
this
is
because
the
probability
that
a
high
dietary
exposure
day
would
occur
during
the
four
days
after
application
of
carbaryl
to
the
lawn
is
very
low.
96
Figure
5
Analysis
For
All
Days
Of
The
Year:
EPA
also
ran
the
CARES
model
to
estimate
the
distribution
of
risk
to
all
3
to
5
year
olds,
both
those
with
lawn
applications
and
those
without
lawn
applications.
This
type
of
run
is
similar
to
the
analysis
performed
by
Bayer
in
their
characterization
risk
to
population
sub­
groups.
Figure
5
shows
the
risk
to
all
3
to
5
year
olds,
both
those
with
lawn
applications
and
those
without
lawn
applications
for
every
day
of
the
year.
The
MOE
from
lawn
application
at
the
99.9
percentile
for
all
3
to
5
year
olds
for
all
days
of
the
year
is
around
100,000.
Compare
this
to
the
MOE
of
approximately
10
at
the
99.9
percentile
for
3
to
5
year
olds
in
during
the
4
days
after
application
of
carbaryl
to
their
lawns.
Since
the
probability
of
a
lawn
application
of
is
less
than
1
percent,
99
percent
of
3
to
5
year
olds
will
have
no
exposure
from
carbaryl
lawn
use.
Since
there
will
be
the
same
number
of
3
to
5
year
olds
exposed
to
lawn
care
(
the
same
individuals
as
Figure
2)
but
almost
100
times
the
individuals
used
to
calculate
percentages
for
the
risk
distributions
and
all
days
of
year
were
used
(
not
just
the
4
days
after
application)
the
number
of
potential
exposure
events
is
much
higher
than
for
exposed
individuals
only,
discussed
in
the
previous
section.
Therefore
the
risk
in
this
type
of
analysis
is
considerably
lower
at
a
given
percentile
of
the
population.
Figure
5
demonstrates
this.

Figure
6
shows
the
dietary
risk
from
cabaryl
residues
in
food
to
all
to
all
3
to
5
year
olds,
both
those
with
lawn
applications
and
those
without
lawn
applications
for
every
day
of
the
year.
The
MOE
from
food
at
the
99.9
percentile
for
all
3
to
5
year
olds
for
all
days
of
the
year
is
around
120.
In
Figure
6,
the
most
exposed
children
have
dietary
MOE's
in
the
range
of
10.
Compare
this
to
the
highest
dietary
MOE
of
over
100
at
the
99.9
percentile
for
only
those
3
to
5
year
olds
during
the
4
days
after
application
of
carbaryl
to
their
lawns.
This
lower
MOE
in
Figure
6
is
because
the
number
of
potential
dietary
person­
exposure
days
is
orders
of
magnitudes
higher
for
all
3
to
5
year
olds
for
all
days
of
the
year.
This
produces
enough
exposure
events
such
that
a
few
low­
probability
high
exposure
dietary
events
start
to
show
up.
97
Figure
6
Figure
7
Figure
7
shows
the
distribution
of
the
aggregated
risk
to
all
3
to
5
year
olds
from
the
application
of
carbaryl
to
the
lawn
and
from
carbaryl
residues
in
food
during
all
days
of
the
year.
In
the
graph
dietary
exposures
dominate
the
aggregate
exposure
for
all
but
the
few
highest
exposure
events.
This
is
because
of
the
very
few
lawn
application
events
(
in
comparison
to
food
which
happens
to
almost
everyone
ever
day
of
the
year)
and
because
of
the
low
probability
that
a
high
lawn
exposure
day
would
occur
during
a
high
dietary
day.
At
very
upper
portion
of
probability
distribution
(
well
above
99.99%)
there
are
a
few
high
exposure
lawn
events
contributing
to
aggregate
MOE's
in
the
range
of
10.
98
6.0
CUMULATIVE
RISK
The
Food
Quality
Protection
Act
(
1996)
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non­
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.

Carbaryl
is
a
member
of
the
carbamate
class
of
pesticides.
This
class
also
includes
aldicarb,
methomyl
and
oxamyl
among
others.
The
N­
methyl
carbamates,
as
a
group,
have
been
determined
to
share
a
common
mechanism
of
toxicity
(
July
2001
memo
from
Office
Director
Marcia
Mulkey).
However,
a
cumulative
risk
assessment
has
not
been
performed
as
part
of
this
review
because
HED
is
currently
examining
approaches
for
completing
this
type
of
assessment.

The
Agency
also
does
not
believe
that
calculation
of
cumulative
risks
for
the
organophosphorus
(
OP)
pesticides
and
N­
methyl
carbamates
(
including
carbaryl)
is
appropriate.
Both
classes
of
compounds
inhibit
acetylcholinesterase
(
ChE),
but
there
are
differences
in
pharmacokinetics
and
pharmacodynamics
between
the
two
groups
that
raise
significant
uncertainty
regarding
the
appropriateness
of
dose
addition
and
that
will
have
a
significant
impact
on
cumulative
toxicity.
Thus,
these
two
classes
of
anticholinesterase
compounds
have
a
very
different
time
course
of
events
including:
time
to
peak
effect,
compound
half­
life
in
the
body,
duration
of
action,
and
recovery
time
after
exposure.
EPA's
Office
of
Research
and
Development
is
currently
investigating
the
pharmacokinetics
and
pharmcodynamics
of
Nmethyl
carbamates
which
will
provide
a
more
solid
scientific
foundation
for
the
cumulative
assessment
of
these
pesticides.

HED
has
recently
developed
a
framework
that
it
proposes
to
use
for
conducting
cumulative
risk
assessments
on
substances
that
have
a
common
mechanism
of
toxicity.
This
guidance
reflects
recent
revisions
based
on
review
and
comment
from
earlier
guidance
issued
on
June
30,
2000
(
65
FR
40644­
40650)
that
is
available
from
the
OPP
Website
at:
http://
www.
epa.
gov/
fedrgstr/
EPAPEST
2000/
June/
Day­
30/
6049.
pdf.
The
recently
revised
guidance
is
entitled
Guidance
on
Cumulative
Risk
Assessment
of
Pesticide
Chemicals
That
Have
A
Common
Mechanism
Of
Toxicity
(
January
14,
2002).
In
the
guidance,
it
is
stated
that
a
cumulative
risk
assessment
of
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
will
not
be
conducted
until
an
aggregate
exposure
assessment
of
each
substance
has
been
completed.

7.0
OCCUPATIONAL
RISK
ASSESSMENT
This
section
of
the
risk
assessment
addresses
exposures
to
individuals
who
are
exposed
as
part
of
their
employment.
These
exposures
can
occur
because
people
have
contact
with
carbaryl
residues
while
using
commercial
products
containing
carbaryl
(
i.
e.,
handlers)
or
by
being
in
areas
that
have
been
previously
treated
(
postapplication
workers).
A
thorough
understanding
of
how
carbaryl
is
used
is
99
critical
to
the
development
of
a
quality
risk
assessment.
Because
this
information
is
also
critical
to
the
dietary
and
residential
exposure
assessments
presented
above,
available
use
information
has
already
been
summarized.
Please
refer
to
Section
4.1:
Summary
of
Registered
Uses
for
further
information
on
this
topic.
All
calculations
for
occupationally
exposed
people
are
based
on
this
information.
Also,
for
more
detailed
information
pertaining
to
the
occupational
risk
calculations,
please
refer
to
the
Occupational
and
Residential
Exposure
Assessment
(
D287251)
prepared
by
Jeff
Dawson.
The
document
D287251
contains
detailed
descriptions
of
the
data
used,
methods,
and
risks
calculated
for
each
scenario.

Section
7.1:
Occupational
Handler
Risk
Assessment
describes
the
data,
methods,
and
risk
results
(
both
cancer
and
noncancer)
associated
with
the
use
of
commercial
products
which
contain
carbaryl.
Section
7.2:
Occupational
Postapplication
Risk
Assessment
describes
the
data,
methods,
and
risk
results
associated
with
exposures
to
workers
as
they
complete
activities
required
for
the
production
and
maintenance
of
crops
or
other
areas
such
as
turf
that
might
require
the
use
of
carbaryl.
Section
7.3:
Occupational
Risk
Characterization
provides
information
pertaining
to
the
quality
of
the
assessment
including
data
used,
uncertainties
with
the
methods,
and
any
other
information
that
might
be
used
to
describe
the
quality
of
the
results.
Section
7.4:
Human
and
Domestic
Animal
Incident
Data
Review
describes
the
analysis
conducted
by
Agency
epidemiologists.

7.1
Occupational
Handler
Risk
Assessment
The
Agency
completes
occupational
handler
risk
assessments
using
scenarios
as
the
basis
for
the
calculations
as
described
in
the
U.
S.
EPA
Guidelines
For
Exposure
Assessment.
For
commercial
pesticide
products,
the
Agency
categorizes
handler
exposures
based
on
the
kinds
of
formulations
(
e.
g.,
liquids
or
various
solids),
the
kinds
of
equipment
used
to
make
applications
(
e.
g.,
groundboom,
aerial,
or
airblast),
the
nature
of
the
task
(
e.
g.,
mixing/
loading,
applying,
or
both
combined),
and
the
level
of
personal
protection
used.
Identifying
the
duration
of
exposure
is
also
a
critical
element
in
the
development
of
a
risk
assessment
to
ensure
that
the
proper
hazard
component
is
used.

For
carbaryl
uses,
the
Agency
identified
28
major
occupational
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
potentially
can
be
used
for
carbaryl
applications.
Most
of
the
scenarios
were
classified
as
having
short­
term
and
intermediate­
term
exposures
(
up
to
30
days
and
30
days
to
several
months,
respectively).
A
few
other
scenarios
have
also
been
addressed
that
are
thought
to
have
long­
term
or
chronic
exposures
(
several
months
to
every
working
day)
associated
with
them
in
the
greenhouse
and
floriculture
industry.

The
quantitative
exposure/
risk
assessment
developed
for
occupational
handlers
was
based
on
the
following
scenarios.
[
Note:
The
numbers
correspond
to
the
tracking
system
included
in
D287251.]

Mixing/
Loading
(
1a)
Dry
Flowable
for
Aerial/
Chemigation
in
Agriculture;
(
1b)
Dry
Flowable
for
Airblast;
(
1c)
Dry
Flowable
for
Groundboom;
(
1d)
Dry
Flowable
for
High
Pressure
Handwand
and
Right
of
Way
Sprayers;
(
1e)
Dry
Flowable
for
LCO
Applications;
(
1f)
Dry
Flowable
for
Aerial
Wide
Area
Uses;
(
2a)
Granular
for
Aerial;
(
2b)
Granular
for
Broadcast
Spreader;
100
(
3a)
Liquids
for
Aerial/
Chemigation;
(
3b)
Liquids
for
Airblast;
(
3c)
Liquids
for
Groundboom;
(
3d)
Liquids
for
High
Pressure
Handwand
and
Right
of
Way
Sprayers;
(
3e)
Liquids
for
LCO
Applications;
(
3f)
Liquids
for
Aerial
Wide
Area
Uses;
(
3g)
Liquids
for
Ground
Wide
Area
Uses;
(
4a)
Wettable
Powder
for
Aerial/
Chemigation;
(
4b)
Wettable
Powder
for
Airblast;
(
4c)
Wettable
Powder
for
Groundboom;
(
4d)
Wettable
Powder
for
High
Pressure
Handwand
and
Right
of
Way
Sprayers;
(
4e)
Wettable
Powder
for
LCO
Applications;
(
4f)
Wettable
Powder
for
Aerial
Wide
Area
Uses;

Applicator:
(
5a)
Aerial/
Liquid
Application;
(
5b)
Aerial/
Liquid
Wide
Area
Application;
(
5c)
Aerial/
Granular
Application;
(
6a)
Airblast
Application;
(
6b)
Wide
Area
Ground
Fogger
(
Airblast
as
surrogate);
(
7)
Groundboom
Application;
(
8)
Solid
Broadcast
Spreader
Application;
(
9)
Aerosol
Can
Application;
(
10)
Trigger
Sprayer
(
RTU)
Application;
(
11)
Right­
of­
Way
Sprayer
Application;
(
12)
High
Pressure
Handwand
Application;
(
13)
Veterinary
Technician/
Animal
Groomer
Liquid
Application;
(
14)
Veterinary
Technician/
Animal
Groomer
Dust
Application;
(
15)
Granulars/
Bait
and
Pellets
Dispersed
by
Hand;
(
16)
Granulars/
Bait
and
Pellets
Dispersed
with
Spoon;

Mixer/
Loader/
Applicator:
(
17)
Low
Pressure/
High
Volume
Turfgun
Application;
(
18a)
Wettable
powder,
Low
pressure
handwand;
(
18b)
Liquid:
Low
Pressure
Handwand;
(
19)
Backpack;
(
20)
Granular
Belly
Grinder;
(
21)
Push­
type
Granular
Spreader;
(
22)
Handheld
Fogger;
(
23)
Powered
Backpack;
(
24)
Granular
Backpack;
101
(
25)
Tree
Injection;
(
26)
Drenching/
Dipping
Seedlings
For
Propagation;
(
27)
Sprinkler
Can;

Flaggers:
(
28a)
Flagging
For
Liquid
Sprays;
and
(
28b)
Flagging
For
Granular
Applications.

For
each
of
these
scenarios,
risk
calculations
were
completed
based
on
eight
levels
of
personal
protection
that
were
defined
based
on
different
combinations
of
the
following:

1)
Baseline
Protection
(
typical
work
clothing
or
a
long­
sleeved
shirt
and
long
pants,
no
respiratory
protection
and
no
chemical­
resistant
gloves);

2)
Minimum
Personal
Protective
Equipment
(
baseline
scenario
with
the
use
of
chemicalresistant
gloves
and
a
dust/
mist
respirator
with
a
protection
factor
of
5);

3)
Maximum
Personal
Protective
Equipment
(
baseline
scenario
with
the
use
of
an
additional
layer
of
clothing
(
e.
g.,
a
pair
of
coveralls),
chemical­
resistant
gloves,
and
an
air
purifying
respirator
with
a
protection
factor
of
10);

4)
Engineering
Controls
(
use
of
an
appropriate
engineering
control
such
as
a
closed
tractor
cab
or
closed
loading
system
for
granulars
or
liquids).

Current
labels
mostly
require
single
layer
clothing,
chemical­
resistant
gloves,
and
no
respirator.

Data
and
Assumptions
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
handler
risk
assessments.
The
inputs
are
consistent
with
current
Agency
policy
for
completing
occupational
exposure
assessments
(
e.
g.,
PHED
Surrogate
Exposure
Guide
and
Exposac
Policy
9:
Standard
Values
For
Daily
Acres
Treated
In
Agriculture).
[
Note:
PHED
is
a
database
that
contains
monitored
field
data
used
for
assessments.
See
Section
4.4.2
Residential
Handler
Risk
Assessment
above
for
further
information.]

°
Average
body
weight
of
an
adult
handler
is
70
kg
as
described
in
the
residential
handler
assessments
(
see
Section
4.4.2).

°
Several
generic
protection
factors
were
used
to
calculate
handler
exposures.
The
protection
factors
used
for
clothing
layers
(
i.
e.,
50%)
and
gloves
(
90%)
have
not
been
completely
evaluated
by
the
Agency.
Additionally,
protection
factor
was
used
to
estimate
exposures
that
involve
engineering
controls
if
required
(
98%).
The
values
used
for
respiratory
protection
(
i.
e.,
PF
5
or
PF
10)
are
based
on
the
NIOSH
Respirator
Decision
Logic.
For
airblast
open
cab
applicators,
it
was
indicated
by
Bayer
that
protective
headgear
should
be
considered
in
maximum
protective
equipment
scenarios
and
that
a
label
amendment
would
be
considered.
As
such,
a
50
percent
protection
factor
was
used
with
the
stipulation
that
this
become
a
label
requirement.

°
For
cancer
risk
calculations,
a
value
of
30
application
events
per
year
for
all
commercial
102
applicator
scenarios
and
10
days
per
year
to
account
for
private
growers
was
used.
These
values
are
supported
by
the
data
included
in
the
University
of
California
studies
of
seasonal
labor
in
California
and
the
recent
Department
of
Labor
National
Agricultural
Worker
Survey
(
NAWS).
The
exposure
duration
values
used
by
HED
in
the
cancer
risk
assessment
are
consistent
with
those
used
for
other
chemicals
(
i.
e.,
35
working
years
and
70
year
lifetime).

°
In
many
scenarios,
it
is
likely
that
a
grower
would
mix,
load,
and
apply
chemicals
all
in
one
day
because
of
limited
labor,
efficiency,
or
many
other
reasons.
In
most
cases,
mixing/
loading
and
application
are
considered
separate
job
functions
because
of
the
available
data
and
also
it
allows
for
more
flexibility
in
the
risk
management
phase
(
e.
g.,
assigning
requirements
for
specific
types
of
protective
equipment).

°
Flagging
during
aerial
applications
has
been
addressed
even
though
it
may
be
limited
in
nature
(
10
to
15%
of
aerial
application
operations).
Engineering
controls
(
e.
g.,
Global
Positioning
Satellite
technology)
are
now
predominantly
used
by
pilots
as
indicated
by
the
1998
National
Agricultural
Aviation
Association
(
NAAA)
survey
of
their
membership.

°
The
maximum
application
rates
allowed
by
labels
were
used
in
the
risk
assessments.
If
additional
information,
such
as
average
or
typical
rates,
were
available,
these
values
were
used
as
well
in
order
to
allow
risk
managers
to
make
a
more
informed
risk
management
decision.
Average
application
rates
were
available
from
the
SMART
meeting
and
BEAD's
QUA.

°
Factors
used
to
evaluate
specialized
use
patterns
(
e.
g.,
oyster
bed
24C
in
WA,
mosquito
control,
and
APHIS
grasshopper
control)
were
developed
based
on
extensive
communications
with
the
appropriate
Agencies
and
associations
which
would
conduct
these
kinds
of
operations
(
e.
g.,
USDA,
AMCA,
and
WA).

°
The
average
occupational
workday
is
assumed
to
be
8
hours.
The
daily
areas
to
be
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,
animals).
The
factors
used
for
the
carbaryl
assessment
are
the
same
as
those
detailed
in
the
HED
Science
Advisory
Committee
on
Exposure
Policy
9:
Standard
Values
for
Daily
Acres
Treated
in
Agriculture.
The
daily
volumes
handled
and
acres
treated,
excerpted
from
the
policy,
in
each
occupational
scenario
include:

°
Aerial
applications:
1200
acres
for
large
field
crops
and
forest
treatments,
350
acres
for
other
field
crops,
and
7500
acres
for
mosquito
control
adulticide
applications;
°
Groundboom:
200
acres
for
large
field
crops
(
e.
g.,
wheat
and
corn),
80
acres
treated
for
other
field
crop
groundboom
applications,
and
40
acres
on
golf
course
turf;
°
Airblast:
40
acres
treated
for
agricultural
applications;
9The
veterinary
and
fireant
treatments
are
not
included
in
the
policy
but
represent
values
that
have
been
used
by
HED
in
previous
assessments.

10
Non­
ORETF
data
included
in
MRIDs
451672­
01
and
452507­
01
were
from
studies
submitted
by
Bayer
.
The
propoxur
trigger
sprayer
study
has
a
signed
PHED
data
waiver
but
has
not
been
included
into
PHED.
It
also
is
the
property
of
Bayer.
Additionally,
some
of
the
handler
exposure
data
used
in
this
assessment
are
from
the
ORETF,
of
which
Bayer
,
is
a
member.

103
°
8
pet
animals
treated
per
day
for
veterinary
and
professional
groomer
uses9;
°
1000
gallons
of
spray
solution
prepared
when
mixing/
loading
liquids
for
high
pressure
handwand
application
or
making
the
application;
°
40
gallons
when
mixing/
loading/
applying
liquids
with
a
backpack
sprayer
or
a
low
pressure
handwand
sprayer;
°
10
mounds
per
day
treated
for
fire
ant
applications.
10
°
For
direct
pet
animal
treatments,
the
Residential
SOPs,
were
used
to
define
the
amount
of
chemical
that
can
be
used
to
treat
a
single
animal,
which
in
turn
was
used
to
calculate
total
human
dose
levels.
The
actual
per
animal
application
rates
used
were
½
of
a
6
oz
bottle
for
liquid
shampoos
(
0.5%)
and
½
of
4
lb
container
for
animal
powders
(
10%).

°
Ultra
low
volume
applications
for
uses,
such
as
adulticide
mosquito
control,
were
considered
using
a
large
acreage
estimate
to
aerial
applicators.
The
mosquito
adulticide
uses
were
evaluated
in
the
same
manner
as
other
chemicals
used
for
that
purpose
(
e.
g.,
the
same
acreage
estimates
were
used
as
for
other
chemicals
like
fenthion
and
naled).
The
acres/
day
inputs
for
the
APHIS
grasshopper
control
scenarios
were
defined
based
on
use
information
provided
by
USDA/
APHIS.

°
There
were
several
scenarios
which
were
identified
for
which
no
appropriate
exposure
data
are
known
to
exist.
These
include:
animal
grooming
dust
application;
dust
applications
in
agriculture;
handheld
fogging
for
mosquito
and
other
pest
treatments;
power
backpack
application;
tree
injection;
and
drenching/
dipping
seedlings
(
the
mixing/
loading
component
only
of
this
scenario
has
been
addressed
quantitatively).

The
unit
exposure
values
(
mg
ai
exposure/
lb
ai
handled)
used
in
this
assessment
were
predominantly
based
on
PHED
and
summarized
in
the
surrogate
exposure
guidance.
In
addition
to
PHED,
five
studies
were
used
by
the
Agency.
One
used
carbaryl
to
quantify
exposures
for
professional
dog
groomers.
Two
were
completed
by
Bayer
using
other
chemicals
that
quantified
exposures
to
granular
products
using
a
backpack
application
device.
One
was
submitted
by
Bayer
that
quantified
exposures
using
a
ready­
to­
use
trigger
sprayer.
Lastly,
an
ORETF
(
Outdoor
Residential
Exposure
Task
Force,
of
which
Bayer
is
a
member)
study
that
quantified
exposures
of
professional
lawncare
operators
using
granular
and
liquid
products.
There
are
no
data
compensation
issues
with
any
of
these
data.
10
In
all
cases,
what
appears
to
be
the
best
available
data
have
been
used
to
complete
the
calculations.
104
7.1.1
Occupational
Handler
Non­
Cancer
Risks
Noncancer
risks
were
calculated
using
the
MOE
approach,
as
described
under
4.4.2.1.
The
major
differences
are
that
personal
protective
devices
are
used
and
longer
duration
exposures
(
i.
e.,
intermediate­
term
and
chronic)
have
been
considered
as
appropriate.
Risk
estimates
for
short­
and
intermediate­
term
exposures
are
similar
because
all
numerical
inputs
for
both
durations
and
the
target
MOEs
were
identical.
A
NOAEL
from
the
21­
day
dermal
toxicity
study
in
rats
using
technical
grade
carbaryl
was
used
to
calculate
results
for
both
durations
(
i.
e.,
20
mg/
kg/
day).
A
NOAEL
from
the
developmental
neurotoxicity
study
in
rats,
that
also
observed
at
the
same
level
in
a
subchronic
neurotoxicity
study
in
rats
(
i.
e.,
1
mg/
kg/
day),
was
used
to
calculate
inhalation
risks.
The
target
MOE
was
100
for
all
assessments.
In
the
chronic
assessments,
a
LOAEL
(
3.1.
mg/
kg/
day)
has
been
used
from
a
1
year
dog
feeding
study
for
both
dermal
and
inhalation
exposures
(
with
a
dermal
absorption
factor
of
12.7
percent
applied).
The
target
MOE
for
the
chronic
assessments
is
300
because
a
LOAEL
was
determined
instead
of
a
NOAEL.

Short­/
Intermediate­
term
Risks:
In
most
scenarios,
MOEs
meet
or
exceed
the
required
uncertainty
factor
of
100
at
some
level
of
personal
protection.
For
the
most
part,
current
label
requirements
for
personal
protection
(
single
layer
clothing,
gloves,
and
no
respirator)
appear
to
be
generally
inadequate
for
most
scenarios
except
for
operations
where
exposures
are
low
and
the
amount
of
chemical
used
is
also
low.
Table
26
summarizes
the
results
for
short­
term
and
intermediate­
term
occupational
handlers.
[
Note:
Scenarios
where
MOEs
are
still
of
concern
(
i.
e.,
<
100)
for
any
personal
protection
considered
are
highlighted
and
just
the
minimum
required
personal
protective
equipment
(
PPE)
is
highlighted
if
it
exceeds
current
label
requirements
but
target
MOEs
can
be
achieved
at
higher
than
label
requirements
for
mitigation.]

Table
26:
Summary
of
Short­/
Intermediate­
Term
Occupational
Handler
Noncancer
Risks
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
MOEs
Min.
Req.
PPE
Mixer/
Loaders
1a
Dry
Flowable:
Aerial/
Chemigation
1­
2
(
wheat/
corn)
2­
5
(
veg.,
stone
fruit,
24C
on
oysters)
1200
350
363­
726
498­
1244
EC
EC
1b
Dry
Flowable:
Airblast
7.5­
16
(
various
fruit
&
nut
trees)
5
(
nuts)
1.1­
3
(
pome
&
stone
fruit,
grapes)
40
40
40
1360­
2902
101
143­
391
EC
SL/
GL/
PF5
Baseline
1c
Dry
Flowable:
Groundboom
1.5­
2
(
wheat/
corn)
2
(
strawberry/
veg)
8
(
turf/
golf
courses)
4
(
turf/
golf
courses)
200
80
40
40
2177­
2902
107
2721
108
EC
Baseline
EC
Baseline
1d
Dry
Flowable:
High
Press
HW/
ROW
Sprayer
4
lb
ai/
100
gal
(
poultry)
1000
gal
430
Baseline
1e
Dry
Flowable:
Low
press./
High
Vol.
Turfgun
4
­
8
(
LCO
on
turf)
5
430­
860
Baseline
1f
Dry
Flowable:
Wide
area
aerial
2
(
rangeland/
forestry)
7500
58
MOE
<
100
Table
26:
Summary
of
Short­/
Intermediate­
Term
Occupational
Handler
Noncancer
Risks
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
MOEs
Min.
Req.
PPE
105
2a
Granular:
Aerial
Application
2
(
corn)
2
(
corn)
0.03
(
APHIS
grasshopper)
1200
350
1000­
6000
688
146
183­
1100
EC
SL/
GL/
PF5
Baseline
2b
Granular:
Solid
broadcast
spreader
1.5
(
wheat/
corn)
2
(
wheat/
corn)
2
(
vegetables)
6
(
turf/
golf
courses)
9
(
turf/
golf
courses)
200
200
80
40
40
110
256
206
138
284
Baseline
SL/
GL/
PF5
Baseline
Baseline
SL/
GL/
PF5
3a
Liquid:
Aerial/
Chemigation
1.5­
2
(
wheat,
max
corn)
1
(
avg.
corn)
5
(
stone
fruit)
2
(
vegetables)
1200
1200
350
350
57­
76
114
78
103
All
MOEs
<
100
EC
MOE<
100
DL/
GL/
PF10
3b
Liquid:
Airblast
Application
16
(
Citrus­
24C
in
California)
7.5
(
Citrus)
5
(
Nuts)
1.1­
3
(
Grapes,
pome
&
stone
fruit)
40
40
40
40
100
168
149
248­
677
DL/
GL/
PF10
SL/
GL/
PF5
SL/
GL/
NR
SL/
GL/
NR
3c
Liquid:
Groundboom
1.5
(
wheat)
2
(
corn)
2
(
strawberries)
8
(
turf/
golf
courses)
4
(
turf/
golf
courses)
200
200
80
40
40
168
126
186
157
186
SL/
GL/
PF5
SL/
GL/
PF5
SL/
GL/
NR
SL/
GL/
PF5
SL/
GL/
NR
3d
Liquid:
High
Press
HW/
ROW
Sprayer
4
lb
ai/
100
gal
(
poultry)
1000
gal
745
SL/
GL/
NR
3e
Liquid:
Low
press./
High
Vol.
Turfgun
4
­
8
(
LCO
on
turf)
5
745­
1489
SL/
GL/
NR
3f
Liquid:
Wide
area
aerial
2
(
Range/
Forestry)
0.016
(
Mosquito
adulticide)
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
0.375­
0.5
(
APHIS
grasshopper)
0.125
(
APHIS
grasshopper)
7500
7500
7500
7500
6000
6000
9
248
121
18
46­
61
182
MOE
<
100
SL/
GL/
NR
EC
MOE
<
100
MOE<
100
EC
3g
Liquid:
Wide
area
ground
0.016
(
Mosquito
adulticide)
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
3000
3000
3000
621
112
45
SL/
GL/
NR
SL/
GL/
PF5
MOE
<
100
4a
Wettable
Powders:
Aerial
1­
2
(
Wheat/
corn)
5
(
stone
fruit)
2
(
vegetables)
1200
350
350
40­
80
55
137
All
MOEs
<
100
MOE
<
100
EC
4b
Wettable
Powders:
Airblast
16
(
Citrus­
24C
in
California)
1.1­
7.5
(
Citrus,
nuts,
grapes,
pome
&
stone
fruit)
40
40
150
320­
2180
EC
EC
4c
Wettable
Powders:
Groundboom
1.5­
2
(
wheat/
corn)
2
(
strawberries)
4­
8
(
turf/
golf
courses)
200
80
40
240­
320
599
299­
599
EC
EC
EC
4d
Wettable
Powders:
High
Press
HW/
ROW
Sprayer
4
lb
ai/
100
gal
(
poultry)
1000
gal
102
SL/
GL/
PF5
Table
26:
Summary
of
Short­/
Intermediate­
Term
Occupational
Handler
Noncancer
Risks
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
MOEs
Min.
Req.
PPE
106
4e
Wettable
Powders:
Low
press./
High
Vol.
Turfgun
4
(
LCO
on
turf)
8
(
LCO
on
turf)
55
102
205
SL/
GL/
PF5
SL/
GL/
PF5
4f
Wettable
Powders:
Wide
area
aerial
2
(
Range/
Forestry)
7500
6
MOE<
100
Applicators
5a
Aerial:
Agricultural
uses,
liquid
sprays
1­
1.5
(
wheat/
avg.
corn)
2
(
max
corn)
5
(
stone
fruit)
2
(
vegetables,
24C
on
oysters)
1200
1200
350
350
113­
170
85
116
292
EC
MOE<
100
EC
EC
5b
Aerial:
Wide
area
uses,
liquid
sprays
2
(
Range/
Forestry)
0.016­
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
0.375­
0.5
(
APHIS
grasshopper)
0.125
(
APHIS
grasshopper)
7500
7500
7500
6000
6000
14
181­
1700
27
68­
91
272
MOE<
100
EC
MOE<
100
MOE<
100
EC
5c
Aerial:
Agricultural
uses,
granular
applications
2
(
corn)
2
(
corn)
0.03
(
APHIS
grasshopper)
1200
350
1000­
6000
21
72
281­
1685
MOE<
100
MOE<
100
EC
6a
Airblast:
Agricultural
uses
16
(
Citrus
24C
in
California)
3­
7.5
(
Citrus,
nuts,
max
pome/
stone
fruit)
2
(
grapes)
1.1
(
avg.
stone
fruit)
40
40
40
40
105
224­
561
118
123
EC
EC
DL/
HEAD/
GL/
PF5
SL/
GL/
PF5
6b
Airblast:
Wide
area
uses,
liquid
sprays
0.016
(
Mosquito
adulticide)
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
3000
3000
3000
113
150
22
SL/
GL/
PF5
EC
MOE<
100
7
Groundboom
1.5­
2
(
Wheat,
corn)
2
(
Strawberries)
4­
8
(
Turf/
golf
course)
200
80
40
122­
162
304
152­
304
Baseline
Baseline
Baseline
8
Solid
broadcast
spreader
(
granular)
1.5­
2
(
Wheat,
corn)
2
(
Strawberries)
4­
8
(
Turf/
golf
course)
200
80
40
103­
138
258
115­
172
Baseline
Baseline
Baseline
9
Aerosol
Can
0.01
lb
ai/
can
2
cans
324
Baseline
10
Trigger
pump
sprayer
0.01
lb
ai/
can
1
can
8772
SL/
GL/
NR
11
Right
of
way
sprayer
1.5
lb
ai/
100
gallons
1000
gallons
199
SL/
GL/
NR
12
High
pressure
handwand
4
lb
ai/
100
gallons
1000
gallons
66
MOE<
100
13
Animal
groomer,
liquid
application
0.01
lb
ai/
dog
8
dogs
9.7
MOE<
100
14
Animal
groomer,
dust
application
(
see
App
C/
Table
3)
0.2
lb
ai/
dog
8
dogs
8750
Baseline
(
dermal
exp
only)

15
Granulars
&
baits
applied
by
hand
9
(
Ornamentals
&
gardens)
1
3.8
MOE<
100
16
Granulars
&
baits
applied
by
spoon
9
(
Ornamentals
&
garderns)
1
75.1
MOE<
100
Table
26:
Summary
of
Short­/
Intermediate­
Term
Occupational
Handler
Noncancer
Risks
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
MOEs
Min.
Req.
PPE
107
Mixerr/
Loader/
Applicators
17
Low
pressure,
high
volume
turfgun
(
ORETF
Data)
8
(
LCO
Use
on
turf)
4
(
LCO
Use
on
turf)
55
94
104
MOE<
100
SL/
GL/
PF5
18a
Wettable
powder,
low
pressure
handwand
1
lb
ai/
1000
ft2
(
poultry
house)
2%
solution
(
ornamentals)
20,000
ft2
40
gallons
8.3
135
MOE<
100
SL/
GL/
PF5
18b
Liquids,
low
pressure
handwand
1
lb
ai/
1000
ft2
(
poultry
house)
2%
solution
(
ornamentals)
20,000
ft2
40
gallons
127
1699
SL/
GL/
PF5
SL/
GL/
NR
19
Backpack
sprayer
1
lb
ai/
1000
ft2
(
poultry
house)
2%
solution
(
ornamentals)
20,000
ft2
40
gallons
42
565
MOE<
100
Baseline
20
Granular,
bellygrinder
9
(
Turf)
1
27
MOE<
100
21
Granular,
push­
type
spreader
9
(
Turf)
5
124
SL/
GL/
PF5
22
Handheld
fogger
No
data
No
data
No
data
No
data
23
Power
backpack
No
data
No
data
No
data
No
data
24
Granular,
backpack
9
(
Ornamentals)
1
1562
DL/
GL/
NR
25
Tree
injection
No
data
No
data
No
data
No
data
26
Drench/
dipping
forestry/
ornamentals
1.5
lb
ai/
100
gallons
(
Ornamental/
seedling
dip)
100
gallons
199
SL/
GL/
NR
27
Sprinkler
can
2%
solution
(
Ornamentals)
10
gallons
226
Baseline
Flaggers
28a
Flagger:
liquid
sprays
2
(
Corn)
2
(
Vegetables)
1200
350
249
111
EC
Baseline
28b
Flagger:
granular
applications
2
(
Corn)
2
(
Vegetables)
1200
350
101
345
Baseline
Baseline
Baseline
=
Long
pants,
long­
sleeved
shirts,
no
gloves
SL
=
Single
layer
clothing
with
or
without
gloves
(
GL
or
NG)
DL
=
Double
layer
clothing
(
i.
e.,
coveralls
over
SL)
with
or
without
gloves
(
GL
or
NG)
EC
=
Engineering
controls
NR
=
No
respirator
PF5
=
Protection
factor
5
respirator
PF10
=
Protection
factor
10
respirator
Current
label
=
SL/
GL/
NR
Min.
Req.
PPE
=
level
of
PPE
where
MOEs
>
100,
where
current
label
is
exceeded
or
no
adequate
PPE
is
found,
results
are
bold.
MOEs
which
never
exceed
100
are
for
highest
feasible
type
of
mitigation
(
e.
g.,
engineering
control
in
most
cases).

Chronic
Risks:
MOEs
were
calculated
for
only
a
limited
number
of
exposure
ornamental
use
scenarios
where
the
Agency
believes
that
this
kind
of
exposure
pattern
may
exist.
These
calculations
were
also
completed
at
different
levels
of
personal
protection
as
illustrated
in
Table
27.
For
most
scenarios
(
3
of
5),
MOEs
meet
or
exceed
the
required
uncertainty
factor
of
300
at
some
level
of
personal
protection.
The
granular
hand
application
scenarios
are
problematic.
The
uncertainty
factor
of
300
is
required
for
the
chronic
exposure
scenarios
because
a
LOAEL
and
not
a
NOAEL
was
used
for
risk
assessment.
108
Table
27:
Summary
of
Chronic
Occupational
Handler
Noncancer
Risks
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
MOEs
Min.
Req.
PPE
Applicators
15
Granulars
&
baits
applied
by
hand
9
(
Ornamentals
&
gardens)
1
4.7
MOE<
300
16
Granulars
&
baits
applied
by
spoon
9
(
Ornamentals
&
garderns)
1
92.6
MOE<
300
Mixer/
Loader/
Applicators
18a
Wettable
powder,
low
pressure
handwand
2%
solution
(
ornamentals)
40
gallons
302
DL/
GL/
PF10
18b
Liquids,
low
pressure
handwand
2%
solution
(
ornamentals)
40
gallons
3206
SL/
GL/
NR
19
Backpack
sprayer
2%
solution
(
ornamentals)
40
gallons
781
Baseline
Baseline
=
Long
pants,
long­
sleeved
shirts,
no
gloves
SL
=
Single
layer
clothing
with
or
without
gloves
(
GL
or
NG)
DL
=
Double
layer
clothing
(
i.
e.,
coveralls
over
SL)
with
or
without
gloves
(
GL
or
NG)
EC
=
Engineering
controls
NR
=
No
respirator
PF5
=
Protection
factor
5
respirator
PF10
=
Protection
factor
10
respirator
Current
label
=
SL/
GL/
NR
Min.
Req.
PPE
=
level
of
PPE
where
MOEs
>
300,
where
current
label
is
exceeded
or
no
adequate
PPE
is
found,
results
are
bold.
MOEs
which
never
exceed
300
are
for
highest
feasible
type
of
mitigation
(
e.
g.,
PPE
in
most
cases).

7.1.2
Occupational
Handler
Cancer
Risks
Cancer
risks
were
calculated
by
multiplying
the
LADD
and
the
Q1*
(
8.75
x
10­
4
(
mg/
kg/
day)­
1),
as
described
in
4.4.2.2.
HED
considered
two
distinct
populations
in
the
cancer
risk
assessment
­
private
growers
at
10
use
events
per
year
and
commercial
applicators
with
a
use
pattern
of
30
days
per
year.
The
Agency
has
defined
a
range
of
acceptable
cancer
risks
based
on
a
policy
memorandum
dated
August
14,
1996,
by
Office
of
Pesticide
Programs
Director
Dan
Barolo.
This
memo
refers
to
a
predetermined
quantified
"
level
of
concern"
for
occupational
carcinogenic
risk.
Risks
that
are
1
x
10­
6
or
lower
require
no
risk
management
action.
For
those
chemicals
subject
to
reregistration,
the
Agency
is
to
carefully
examine
uses
with
estimated
risks
in
the
10­
6
to
10­
4
range
to
seek
ways
of
cost­
effectively
reducing
risks.
If
carcinogenic
risks
are
in
this
range
for
occupational
handlers,
increased
levels
of
personal
protection
are
warranted
as
is
commonly
applied
with
noncancer
risk
estimates
(
e.
g.,
additional
PPE
or
engineering
controls).
Carcinogenic
risks
that
remain
above
1
x
10­
4
at
the
highest
level
of
mitigation
appropriate
for
that
scenario
remain
a
concern.

Cancer
risks
for
private
growers
(
i.
e.,
10
applications
per
year)
were
calculated
for
different
exposure
scenarios
at
different
levels
of
personal
protection.
All
scenarios
for
private
growers
have
risks
that
are
<
1x10­
4
at
some
level
of
personal
protection.
In
fact,
for
all
but
one
scenario
(
Scen
4f:
Mixing/
loading
Wettable
Powders
for
wide
area
aerial
applications)
cancer
risks
are
<
1x10­
4
at
current
109
label
requirements
for
personal
protection.
If
a
1x10­
6
risk
level
is
specified
as
a
concern,
results
are
similar
in
that
risks
for
a
majority
of
scenarios
are
<
1x10­
6
at
current
label
requirements.
In
fact,
only
8
of
the
140
scenarios
considered
for
private
growers
have
cancer
risks
>
1x10­
6
(
and
less
than
1x10­
4)
even
when
the
most
protective
ensembles
of
either
protective
clothing
or
engineering
controls
are
considered.
As
with
the
risks
calculated
for
private
growers,
cancer
risks
for
commercial
applicators
(
i.
e.,
30
applications
per
year)
were
calculated
for
different
exposure
scenarios
at
different
levels
of
personal
protection.
Again,
risks
for
all
but
one
scenario
(
Scen
4f:
Mixing/
loading
Wettable
Powders
for
wide
area
aerial
applications)
are
less
than
the
1x10­
4
at
current
label
requirements
for
personal
protection
(
i.
e.,
risks
for
this
scenario
are
<
1x10­
4
if
additional
protective
clothing
or
equipment
is
used).
If
a
1x10­
6
risk
level
is
specified
as
a
concern
for
commercial
applicators,
results
indicate
that
risks
for
about
half
of
the
scenarios
considered
are
<
1x10­
6
at
current
label
requirements
and
that
only
21
of
the
140
scenarios
considered
have
cancer
risks
>
1x10­
6
(
and
less
than
1x10­
4)
even
when
the
most
protective
ensembles
of
either
protective
clothing
or
engineering
controls
are
considered.
In
general,
the
cancer
risk
estimates
would
lead
to
less
restrictive
measures
when
compared
to
the
noncancer
results.
Table
28
below
provides
a
summary
of
the
cancer
risks
that
have
been
calculated
for
private
growers
and
commercial
applicators.

Table
28:
Summary
of
Occupational
Handler
Cancer
Risks
For
Private
Growers
and
Commercial
Applicators
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
Private
Growers
Commercial
Applicators
Risk
Min.
Req.
PPE
Risk
Min.
Req.
PPE
Mixer/
Loaders
1a
Dry
Flowable:
Aerial/
Chemigation
1­
2
(
wheat/
corn)
5
(
stone
fruit)
2
(
vegetables,
24C
on
oysters)
1200
350
350
3.7
to
7.4x10­
8
5.4x10­
8
1.0x10­
6
EC
EC
SL/
GL/
PF10
1.1
to
2.2x10­
7
1.6x10­
7
6.5x10­
8
EC
EC
EC
1b
Dry
Flowable:
Airblast
16
(
Citrus,
24C
in
CA)
1.1­
7.5
(
grapes,
various
fruit
&
nut
trees)
40
40
1.0x10­
6
6.9x10­
8
to
4.7x10­
7
Baseline
Baseline
5.9x10­
8
1.4
to
9.3x10­
7
EC
DL/
GL/
PF10
1c
Dry
Flowable:
Groundboom
2
(
corn)
1.5
(
wheat)
2
(
strawberry/
veg)
8
(
turf/
golf
courses)
4
(
turf/
golf
courses)
200
200
80
40
40
4.7x10­
7
6.3x10­
7
2.5x10­
7
5.0x10­
7
2.5x10­
7
Baseline
Baseline
Baseline
Baseline
Baseline
1.0x10­
6
3.7x10­
8
7.5x10­
7
1.0x10­
6
7.5x10­
7
DL/
GL/
NR
EC
Baseline
DL/
GL/
PF5
Baseline
1d
Dry
Flowable:
High
Press
HW/
ROW
Sprayer
4
lb
ai/
100
gal
(
poultry)
1000
gal
6.3x10­
8
Baseline
1.9x10­
7
Baseline
1e
Dry
Flowable:
Low
press./
High
Vol.
Turfgun
4
­
8
(
LCO
on
turf)
5
3.1
to
6.3x10­
8
Baseline
9.4x10­
8
to
1.9x10­
7
Baseline
1f
Dry
Flowable:
Wide
area
aerial
2
(
rangeland/
forestry)
7500
4.6x10­
7
EC
1.4x10­
6
All
<
1x10­
6
2a
Granular:
Aerial
Application
2
(
corn)
2
(
corn)
0.03
(
APHIS
grasshopper)
1200
350
1000­
6000
5.0x10­
7
3.3x10­
7
1.4
to
8.5x10­
8
SL/
GL/
PF5
Baseline
Baseline
9.5x10­
7
9.9x10­
7
4.3x10­
8
to
1.3x10­
7
DL/
GL/
PF5
Baseline
Baseline
2b
Granular:
Solid
broadcast
spreader
1.5­
2
(
wheat/
corn)
2
(
vegetables)
6­
9
(
turf/
golf
courses)
200
80
40
1.4
to
1.9x10­
7
7.6x10­
8
1.1
to
1.7x10­
7
Baseline
Baseline
Baseline
4.3
to
5.7x10­
7
2.3x10­
7
3.4
to
5.1x10­
7
Baseline
Baseline
Baseline
Table
28:
Summary
of
Occupational
Handler
Cancer
Risks
For
Private
Growers
and
Commercial
Applicators
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
Private
Growers
Commercial
Applicators
Risk
Min.
Req.
PPE
Risk
Min.
Req.
PPE
110
3a
Liquid:
Aerial/
Chemigation
1
(
avg.
corn)
1.5
(
wheat)
2
(
corn)
5
(
stone
fruit)
2
(
vegetables)
1200
1200
1200
350
350
9.7x10­
7
9.9x10­
7
8.5x10­
7
9.5x10­
7
4.9x10­
7
SL/
GL/
PF5
DL/
GL/
PF5
SL/
GL/
NR
SL/
GL/
PF5
SL/
GL/
NR
1.1x10­
6
1.4x10­
6
7.2x10­
7
1.1x10­
6
8.6x10­
7
All
<
1x10­
6
All
<
1x10­
6
EC
All
<
1x10­
6
DL/
GL/
PF5
3b
Liquid:
Airblast
Application
16
(
citrus,
24C
in
CA)
1.1­
7.5
(
grapes,
various
fruit
&
nut
trees)
40
40
4.5x10­
7
3.1x10­
8
to
2.1x10­
7
SL/
GL/
NR
SL/
GL/
NR
1.0x10­
6
9.3x10­
8
to
6.4x10­
7
SL/
GL/
PF5
SL/
GL/
NR
3c
Liquid:
Groundboom
1.5­
2
(
wheat/
corn)
2
(
strawberries)
4­
8
(
turf/
golf
courses)
200
80
40
2.1
to
2.8x10­
7
1.1x10­
7
1.1
to
2.3x10­
7
SL/
GL/
NR
SL/
GL/
NR
SL/
GL/
NR
6.4
to
8.5x10­
7
3.4x10­
7
3.4
to
6.8x10­
7
SL/
GL/
NR
SL/
GL/
NR
SL/
GL/
NR
3d
Liquid:
High
Press
HW/
ROW
Sprayer
4
lb
ai/
100
gal
(
poultry)
1000
gal
2.8x10­
8
SL/
GL/
NR
8.5x10­
8
SL/
GL/
NR
3e
Liquid:
Low
press./
High
Vol.
Turfgun
4
­
8
(
LCO
on
turf)
5
1.4
to
2.8x10­
8
SL/
GL/
NR
4.2
to
8.5x10­
8
SL/
GL/
NR
3f
Liquid:
Wide
area
aerial
2
(
Range/
Forestry)
0.016
(
Mosquito
adulticide)
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
0.125
(
APHIS
grasshopper)
0.375
(
APHIS
grasshopper)
0.50
(
APHIS
grasshopper)
7500
7500
7500
7500
6000
6000
6000
3.0x10­
6
8.5x10­
8
7.9x10­
7
1.5x10­
6
5.3x10­
7
9.2x10­
7
6.0x10­
7
All
>
1x10­
6
SL/
GL/
NR
SL/
GL/
NR
All
>
1x10­
6
SL/
GL/
NR
DL/
GL/
PF5
EC
9.1x10­
6
2.5x10­
7
6.8x10­
7
4.5x10­
6
9.2x10­
7
1.4x10­
6
1.8x10­
6
All
>
1x10­
6
SL/
GL/
NR
EC
All
>
1x10­
6
DL/
GL/
PF5
All
>
1x10­
6
All
>
1x10­
6
3g
Liquid:
Wide
area
ground
0.016
(
Mosquito
Adulticide)
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
3000
3000
3000
3.4x10­
8
3.2x10­
7
6.0x10­
7
SL/
GL/
NR
SL/
GL/
NR
EC
1.0x10­
7
9.5x10­
7
1.8x10­
6
SL/
GL/
NR
SL/
GL/
NR
All
>
1x10­
6
4a
Wettable
Powders:
Aerial
1.5
(
Wheat)
2
(
Corn
­
max)
1
(
Corn
­
typ)
5
(
stone
fruit)
2
(
vegetables)
1200
1200
1200
350
350
4.6x10­
7
6.1x10­
7
3.1x10­
7
4.4x10­
7
1.8x10­
7
EC
EC
EC
EC
EC
1.4x10­
6
1.8x10­
6
9.2x10­
7
1.3x10­
6
5.3x10­
7
All
>
1x10­
6
All
>
1x10­
6
EC
All
>
1x10­
6
EC
4b
Wettable
Powders:
Airblast
16
(
Citrus­
24C
in
California)
7.5
(
Citrus)
5
(
Nuts)
3
(
Pome
&
stone
fruit)
2
(
Grapes)
1.1(
Avg.
stone
fruit)
40
40
40
40
40
40
1.6x10­
7
7.6x10­
8
1.0x10­
6
6.2x10­
7
8.8x10­
7
4.9x10­
7
EC
EC
SL/
GL/
PF5
SL/
GL/
PF5
SL/
GL/
NR
SL/
GL/
NR
4.9x10­
7
2.3x10­
7
1.5x10­
7
9.2x10­
8
1.0x10­
6
5.7x10­
7
EC
EC
EC
EC
DL/
GL/
PF5
DL/
GL/
PF5
4c
Wettable
Powders:
Groundboom
1.5
(
wheat)
2
(
corn)
2
(
strawberries)
8
(
turf/
golf
courses)
4
(
turf/
golf
courses)
200
200
80
40
40
7.6x10­
8
1.0x10­
7
8.3x10­
7
8.1x10­
8
8.3x10­
7
EC
EC
SL/
GL/
PF5
EC
SL/
GL/
PF5
2.3x10­
7
3.1x10­
7
1.2x10­
7
2.4x10­
7
1.2x10­
7
EC
EC
EC
EC
EC
4d
Wettable
Powders:
High
Press
HW/
ROW
Sprayer
4
lb
ai/
100
gal
(
poultry)
1000
gal
4.4x10­
7
SL/
GL/
NR
5.2x10­
7
DL/
GL/
PF5
4e
Wettable
Powders:
Low
press./
High
Vol.
Turfgun
4
(
LCO
on
turf)
8
(
LCO
on
turf)
55
2.2x10­
7
4.4x10­
7
SL/
GL/
NR
SL/
GL/
NR
6.6x10­
7
6.2x10­
7
SL/
GL/
NR
SL/
GL/
PF5
4f
Wettable
Powders:
Wide
area
aerial
2
(
Range/
Forestry)
7500
3.8x10­
6
All
>
1x10­
6
1.1x10­
5
All
>
1x10­
6
Table
28:
Summary
of
Occupational
Handler
Cancer
Risks
For
Private
Growers
and
Commercial
Applicators
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
Private
Growers
Commercial
Applicators
Risk
Min.
Req.
PPE
Risk
Min.
Req.
PPE
111
Applicators
5a
Aerial:
Agricultural
uses,
liquid
sprays
1­
2
(
wheat/
corn)
5
(
stone
fruit)
2
(
vegetables,
24C
on
oysters)
1200
350
350
1.6
to
3.2x10­
7
2.3x10­
7
9.2x10­
8
EC
EC
EC
4.7
to
9.5x10­
7
6.9x10­
7
2.8x10­
7
EC
EC
EC
5b
Aerial:
Wide
area
uses,
liquid
sprays
2
(
Range/
Forestry)
0.016
(
Mosquito
adulticide)
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
0.125
(
APHIS
grasshopper)
0.375
(
APHIS
grasshopper)
0.50
(
APHIS
grasshopper)
7500
7500
7500
7500
6000
6000
6000
2.0x10­
6
1.6x10­
8
1.5x10­
7
9.8x10­
7
9.8x10­
8
3.0x10­
7
3.9x10­
7
All
>
1x10­
6
EC
EC
EC
EC
EC
EC
5.9x10­
6
4.7x10­
8
4.4x10­
7
3.0x10­
6
3.0x10­
7
8.9x10­
7
1.2x10­
6
All
>
1x10­
6
EC
EC
All
>
1x10­
6
EC
EC
All
>
1x10­
6
5c
Aerial:
Agricultural
uses,
granular
applications
2
(
corn)
2
(
corn)
0.03
(
APHIS
grasshopper)
1200
350
1000­
6000
6.2x10­
7
1.8x10­
7
7.8x10­
9
to
4.7x10­
8
EC
EC
EC
1.9x10­
6
5.5x10­
7
2.3x10­
8
to
1.4x10­
7
All
>
1x10­
6
EC
EC
6a
Airblast:
Agricultural
uses
16
(
Citrus
24C
in
California)
7.5
(
Citrus)
5
(
Nuts)
3
(
Pome
&
stone
fruit)
2
(
Grapes)
1.1
(
Avg
pome
&
stone
fruit)
40
40
40
40
40
40
2.7x10­
7
8.9x10­
7
7.2x10­
7
1.0x10­
6
6.9x10­
7
3.8x10­
7
EC
DLHD/
GL/
PF5
DLHD/
GL/
NR
Baseline
Baseline
Baseline
8.2x10­
7
3.9x10­
7
2.6x10­
7
1.0x10­
6
1.0x10­
7
7.9x10­
7
EC
EC
EC
DLHD/
GL/
PF10
DLHD/
GL/
NR
SL/
GL/
NR
6b
Airblast:
Wide
area
fogger
0.016
(
Mosquito
adulticide)
0.15
(
Mosquito
adulticide)
1
(
Mosquito
adulticide)
3000
3000
3000
4.1x10­
7
1.9x10­
7
1.3x10­
6
Baseline
EC
All
>
1x10­
6
8.6x10­
7
5.8x10­
7
3.9x10­
6
SL/
GL/
NR
EC
All
>
1x10­
6
7
Groundboom
1.5­
2
(
Wheat/
corn)
2
(
Strawberries)
8
(
Turf/
golf
course)
4
(
Turf/
golf
course)
200
80
40
40
1.3
to
1.7x10­
7
6.9x10­
8
1.4x10­
7
6.9x10­
8
Baseline
Baseline
Baseline
Baseline
3.9
to
5.2x10­
7
2.1x10­
7
4.1x10­
7
2.1x10­
7
Baseline
Baseline
Baseline
Baseline
8
Solid
broadcast
spreader
(
granular)
1.5­
2
(
Wheat/
corn)
2
(
Strawberries)
4­
8
(
Turf/
golf
course)
200
80
40
1.3
to
1.7x10­
7
6.7x10­
8
1.0
to
1.5x10­
7
Baseline
Baseline
Baseline
3.8
to
5.0x10­
7
2.0x10­
7
3.0
to
4.5x10­
7
Baseline
Baseline
Baseline
9
Aerosol
Can
0.01
lb
ai/
can
2
cans
8.7x10­
8
Baseline
2.6x10­
7
Baseline
10
Trigger
pump
sprayer
0.01
lb
ai/
can
1
can
3.1x10­
9
SL/
GL/
NR
9.4x10­
9
SL/
GL/
NR
11
Right
of
way
sprayer
1.5
lb
ai/
100
gallons
1000
gallons
4.3x10­
7
Baseline
4.1x10­
7
SL/
GL/
NR
12
High
pressure
handwand
4
lb
ai/
100
gallons
1000
gallons
6.6x10­
7
SL/
GL/
PF5
1.1x10­
6
All
>
1x10­
6
13
Animal
groomer,
liquid
application
0.01
lb
ai/
dog
8
dogs
3.1x10­
6
All
>
1x10­
6
9.4x10­
6
All
>
1x10­
6
14
Animal
groomer,
dust
application
0.2
lb
ai/
dog
8
dogs
3.5x10­
9
Baseline
1.0x10­
8
Baseline
15
Granulars
&
baits
applied
by
hand
9
(
Ornamentals
&
gardens)
1
8.0x10­
6
All
>
1x10­
6
2.4x10­
5
All
>
1x10­
6
16
Granulars
&
baits
applied
by
spoon
9
(
Ornamentals
&
garderns)
1
4.6x10­
7
SL/
GL/
NR
1.2x10­
6
All
>
1x10­
6
Table
28:
Summary
of
Occupational
Handler
Cancer
Risks
For
Private
Growers
and
Commercial
Applicators
Scenario
Rate
(
lb
ai/
acre)

[
unless
noted]
Area
Treated
(
acres/
day)

[
unless
noted]
Risk
Summary
Private
Growers
Commercial
Applicators
Risk
Min.
Req.
PPE
Risk
Min.
Req.
PPE
112
Mixerr/
Loader/
Applicators
17
Low
pressure,
high
volume
turfgun
(
ORETF
Data)
8
(
LCO
Use
on
turf)
4
(
LCO
Use
on
turf)
55
3.1x10­
7
6.1x10­
7
SL/
GL/
NR
SL/
GL/
NR
9.7x10­
7
9.2x10­
7
DL/
GL/
PF5
SL/
GL/
NR
18a
Wettable
powder,
low
pressure
handwand
1
lb
ai/
1000
ft2
(
poultry
house)
2%
solution
(
ornamentals)
20,000
ft2
40
gallons
3.1x10­
6
3.0x10­
7
All
>
1x10­
6
SL/
GL/
NR
9.2x10­
6
9.0x10­
7
All
>
1x10­
6
SL/
GL/
NR
18b
Liquids,
low
pressure
handwand
1
lb
ai/
1000
ft2
(
poultry
house)
2%
solution
(
ornamentals)
20,000
ft2
40
gallons
2.1x10­
7
1.2x10­
8
SL/
GL/
PF5
SL/
GL/
NR
6.2x10­
7
3.5x10­
8
SL/
GL/
PF5
SL/
GL/
NR
19
Backpack
sprayer
1
lb
ai/
1000
ft2
(
poultry
house)
2%
solution
(
ornamentals)
20,000
ft2
40
gallons
7.0x10­
7
4.8x10­
8
DL/
GL/
PF5
Baseline
2.2x10­
6
1.4x10­
7
All
>
1x10­
6
Baseline
20
Granular,
bellygrinder
9
(
Turf)
1
1.1x10­
6
All
>
1x10­
6
3.4x10­
6
All
>
1x10­
6
21
Granular,
push­
type
spreader
9
(
Turf)
5
4.0x10­
7
Baseline
8.2x10­
7
SL/
GL/
NR
22
Handheld
fogger
No
data
No
data
No
data
No
data
No
data
No
data
23
Power
backpack
No
data
No
data
No
data
No
data
No
data
No
data
24
Granular,
backpack
9
(
Ornamentals)
1
1.9x10­
8
DL/
GL/
NR
5.8x10­
8
DL/
GL/
NR
25
Tree
injection
No
data
No
data
No
data
No
data
No
data
No
data
26
Drench/
dipping
forestry/
ornamentals
1.5
lb
ai/
100
gallons
(
Ornamental/
seedling
dip)
100
gallons
1.1x10­
7
SL/
GL/
NR
3.2x10­
7
SL/
GL/
NR
27
Sprinkler
can
2%
solution
(
Ornamentals)
10
gallons
1.3x10­
7
Baseline
4.0x10­
7
Baseline
Flaggers
28a
Flagger:
liquid
sprays
2
(
Corn)
2
(
Vegetables)
1200
350
7.2x10­
7
2.1x10­
7
Baseline
Baseline
3.5x10­
7
6.3x10­
7
EC
Baseline
28b
Flagger:
granular
applications
2
(
Corn)
2
(
Vegetables)
1200
350
2.1x10­
7
6.1x10­
8
Baseline
Baseline
6.2x10­
7
1.8x10­
7
Baseline
Baseline
Baseline
=
Long
pants,
long­
sleeved
shirts,
no
gloves
SL
=
Single
layer
clothing
with
or
without
gloves
(
GL
or
NG)
DL
=
Double
layer
clothing
(
i.
e.,
coveralls
over
SL)
with
or
without
gloves
(
GL
or
NG)
EC
=
Engineering
controls
NR
=
No
respirator
PF5
=
Protection
factor
5
respirator
PF10
=
Protection
factor
10
respirator
Current
label
=
SL/
GL/
NR
Min.
Req.
PPE
=
level
of
PPE
where
cancer
risks
>
1x10­
6,
where
current
label
is
exceeded
or
no
adequate
PPE
is
found,
results
are
bold.
Risks
which
never
exceed
1x10­
6
are
for
highest
feasible
type
of
mitigation
(
e.
g.,
engineering
control
in
most
cases).

7.2
Postapplication
Exposures
and
Risks
Workers
can
be
exposed
to
carbaryl
residues
by
entering
previously
treated
areas
to
perform
activities.
Exposure
varies
with
the
specific
tasks
(
i.
e.,
transfer
coefficient),
the
level
of
carbaryl
residue
in
the
environment
(
i.
e.,
DFR
or
TTR
depending
upon
crop),
and
the
duration
of
the
activity.
Calculations
were
completed
using
the
same
approaches
as
already
outlined
above
for
the
residential
postapplication
risk
assessments
(
Section
4.4.3:
Residential
Postapplication
Risks).
113
An
administrative
approach,
the
Restricted
Entry
Interval
(
REI),
is
used
by
the
Agency
to
manage
risks
for
postapplication
workers
doing
hand
labor
activities
that
require
direct
contact
with
treated
plants.
The
REI
is
the
amount
of
time
required
between
application
of
a
pesticide
and
engaging
in
a
task
or
activity
in
a
treated
field
that
it
takes
for
residues
to
dissipate
to
an
appropriate
level.
Current
labels
for
carbaryl
specify
REIs
of
12
hours
after
application
for
all
crop/
cultural
practice
combinations.
In
other
cases
(
e.
g.,
use
of
a
combine
or
other
mechanical
harvesting)
such
as
those
specified
in
the
Agency's
Worker
Protection
Standard
(
40CFR170)
where
no
contact
will
occur,
the
Agency
does
not
rely
on
the
REI
approach
but
adheres
to
the
guidance
included
in
§
170.110.(
c)(
3)
that
allows
for
entry
if
the
criteria
are
met.
The
Agency
also
considers
short­
term
excursions
for
people
for
such
activities
as
unclogging
machinery
as
stipulated
in
the
guidance
included
in
§
170.112.(
c).
The
Agency
encourages
the
use
of
viable
engineering
controls
and
other
means
to
reduce
exposures
provided
they
are
not
overly
burdensome
for
actual
workers.
Generally,
it
should
also
be
noted
that
the
use
of
personal
protective
equipment
or
other
types
of
equipment
to
reduce
exposures
for
postapplication
workers
is
not
considered
a
viable
alternative
for
the
regulatory
process
except
in
specialized
situations
(
e.
g.,
a
rice
scout
will
wear
rubber
boots
in
flooded
paddies).

As
with
the
occupational
handlers,
a
scenario­
driven
approach
is
used
to
assess
risks
for
reentry
workers.
The
Agency's
Policy
003.1
Science
Advisory
Council
For
Exposure
Policy
Regarding
Agricultural
Transfer
Coefficients
is
used
to
define
the
scenarios.
This
policy
presents
various
transfer
coefficients
which
represent
the
range
of
activities
associated
with
18
distinct
crop/
agronomic
groupings
based
on
different
types
of
job
tasks
or
activities
needed
to
produce
fruits,
vegetables,
grains,
and
other
crops.
In
this
scheme,
carbaryl
uses
were
identified
in
all
of
the
crop
groupings
included
in
the
policy.
As
such,
all
agronomic
crop
group/
transfer
coefficients
included
in
this
policy
were
used
to
calculate
postapplication
risks
for
carbaryl.

°
Low
Berry
(
e.
g.,
lowbush
blueberries,
cranberries,
strawberries);
°
Bunch/
bundle
(
e.
g.,
bananas,
hops,
tobacco);
°
Field/
row
crops,
low/
medium
(
e.
g.,
alfalfa,
barley,
beans,
cotton,
peanuts,
peas);
°
Field/
row
crops,
tall
(
e.
g.,
corn,
sorghum,
sunflowers);
°
Cut
flowers
(
e.
g.,
floriculture
crops);
°
Sugarcane;
°
Trees/
fruit,
deciduous
(
e.
g.,
apples,
apricots,
cherry,
peaches,
pears);
°
Trees/
fruit,
evergreen
(
e.
g.,
avocados,
Christmas
trees,
citrus);
°
Trees/
nut
(
e.
g.,
almonds,
hazelnuts,
macadamia,
pecans,
walnuts);
°
Turf/
sod
(
e.
g.,
golf
courses,
sod
farms);
°
Vegetable/
root
(
e.
g.,
beets,
carrots,
onions,
potatoes,
turnips);
°
Vegetable/
cucurbit
(
e.
g.,
cantelope,
cucumber,
squash,
watermelon);
°
Vegetable/
fruiting
(
e.
g.,
eggplant,
pepper,
tomato,
okra);
°
Vegetable/
head
and
stem
brassica
(
e.
g.,
broccoli,
cauliflower,
brussel
sprouts,
cauliflower);
°
Vegetables/
leafy
(
e.
g.,
collards,
greens,
lettuce,
parsley,
spinach,
napa);
°
Vegetables/
stem
and
stalk
(
e.
g.,
artichoke,
asparagus,
pineapple);
°
Vine/
trellis
(
e.
g.,
blackberries,
blueberries,
grapes,
kiwi,
raspberries);
and
°
Nursery
crops
(
e.
g.,
container
and
B&
B
ornamentals).
114
[
Note:
This
assessment
includes
the
latest
transfer
coefficients
for
nursery
crops
which
have
been
recently
submitted
by
ARTF
and
reviewed
by
the
Agency.
Additionally,
the
transfer
coefficient
for
fruit
tree
hand
thinning
has
been
reduced
from
original
policy
estimates
based
on
a
reinterpretation
by
the
Agency
of
the
dataset
upon
which
it
was
based.
The
transfer
coefficient
for
fruit
tree
hand
harvesting
(
and
for
all
related
activities
based
on
this
value)
has
also
been
reduced
based
on
an
analysis
of
the
data
from
a
number
of
ARTF
studies
within
this
cluster.]

Data
and
Assumptions
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
postapplication
risk
assessments,
as
described
below.
The
assumptions
and
factors
used
in
the
risk
calculations
are
consistent
with
current
Agency
policy
for
completing
occupational
exposure
assessments
(
e.
g.,
Exposac
Policy
3
and
guidelines
for
handling
DFR
data).
The
assumptions
and
factors
used
in
the
risk
calculations
include:

C
Many
assumptions
and
factors
which
are
common
to
both
handler
and
postapplication
risk
assessments
are
detailed
in
Section
7.1:
Occupational
Handler
Risk
Assessment
(
e.
g.,
body
weight).
One
major
difference
is
that
in
the
handler
assessment,
many
different
combinations
of
application
rates
and
crop
acres
treated
were
considered
but
in
the
postapplication
assessment,
generally
only
maximum
application
rates
were
considered.

C
Four
dislodgeable
foliar
residue
(
DFR)
studies
were
submitted
that
meet
current
Agency
guidelines
for
sampling
techniques
and
data
quality.
These
studies
were
conducted
with
carbaryl
by
the
Agricultural
Re­
entry
Task
Force
(
ARTF)
using
Iwata's
DFR
sampling
method
on
tobacco
(
harvesting),
olives
(
pruning),
sunflowers
(
scouting),
and
cabbage
(
weeding).
[
Note:
Bayer
is
a
member
of
the
ARTF
so
there
are
no
data
compensation
issues
associated
with
the
use
of
these
data.]
The
percent
of
transferability
averaged
approximately
16
percent
of
the
application
rate
for
the
crops.
A
turf
transferrable
residue
(
TTR)
study
was
also
completed
by
Bayer
using
the
ORETF
roller
method.
The
percent
of
transferability
averaged
approximately
1.1
percent
for
turf
measurements
at
three
different
sites.
HED
used
the
values
from
these
five
studies
for
all
postapplication
crops
and
scenarios
as
the
transferability
is
in
the
appropriate
range
for
use
in
risk
assessments.

C
Short­
term
noncancer
risks
were
calculated
by
comparing
single
day
exposures
based
on
the
dissipation
of
carbaryl
residues
(
i.
e.,
single
day
risks
were
calculated
based
on
daily
DFR
dissipation
values
over
time).
With
the
intermediate­
term
postapplication
risk
calculations,
30­
day
averages
based
on
DFR
dissipation
and
an
appropriate
duration
for
the
endpoint
were
used
to
calculate
postapplication
risks.
In
the
long­
term
assessment,
a
30
day
average
was
used
based
on
the
likelihood
that
carbaryl
could
be
sprayed
at
least
once
a
month
in
the
ornamental
industry.
The
endpoints
used
are
the
same
as
those
described
above
for
the
dermal
component
in
the
handler
assessments
(
i.
e.,
NOAEL
of
20
mg/
kg/
day
from
21­
day
dermal
rat
toxicity
study
using
technical
material
­
target
MOE
=
100
and
LOAEL
of
3.1
mg/
kg/
day
from
a
chronic
dog
feeding
study
with
a
dermal
absorption
factor
defined
in
rats
­
target
MOE
=
300).
115
C
A
standard
pseudo­
first
order
kinetics
analysis
was
used
to
analyze
carbaryl
residue
dissipation
over
time
as
outlined
in
the
Agency's
draft
Series
875
Postapplication
Exposure
Monitoring
Guidelines.
A
more
sophisticated
curve­
fitting
approach
was
not
warranted
because
the
correlation
coefficients
in
the
analysis
were
appropriate
and
the
data
have
been
used
generically
to
extrapolate
to
a
variety
of
other
crops
where
decay
rates
and
mechanisms
may
differ.

C
When
the
available
DFR
data
were
extrapolated
to
other
crops,
the
data
were
adjusted
for
differences
in
application
rate
using
a
simple
proportional
approach.
Carbaryl­
specific
residue
dissipation
data
were
extrapolated
to
crops
where
no
data
were
available.
The
tobacco
DFR
data
were
used
to
complete
all
assessments
for
the
crop/
activity
combinations
included
in
the
bunch/
bundle,
sugarcane,
and
vine/
trellis
agronomic
crop
groups.
The
olive
DFR
data
were
used
to
complete
all
assessments
for
the
crop/
activity
combinations
included
in
all
of
the
tree
fruit
and
nut
crop
groups.
The
sunflower
DFR
data
were
used
to
complete
all
assessments
for
the
crop/
activity
combinations
in
the
tall
field/
row
crop
group.
No
extrapolation
was
required
in
this
assessment.
The
cabbage
study
was
based
on
groundboom
application,
which
is
thought
to
be
much
more
prevalent
in
the
overall
use
pattern
for
carbaryl.
The
cabbage
DFR
data
were
used
to
complete
all
assessments
for
the
crop/
activity
combinations
included
in
the
berry,
cut
flower,
low/
medium
field
and
row,
and
all
vegetable
(
i.
e.,
stem/
stalk,
brassica,
leafy,
fruiting,
cucurbits,
root)
agronomic
crop
groups.
The
turf
TTR
data
were
used
to
complete
all
assessments
for
the
crop/
activity
combinations
for
the
turf
agronomic
crop
group.
No
extrapolation
was
required
in
this
assessment.

°
There
were
several
scenarios
for
which
no
appropriate
exposure
data
are
known
to
exist.
There
are
many
kinds
of
potential
exposure
pathways
that
do
not
involve
foliar
contact
that
have
not
been
addressed
in
this
risk
assessment.
The
scenarios
include:
transplanting
many
crops
including
in
the
ornamental
and
forestry
industry;
thinning
some
crops
such
as
hops;
some
partially
mechanized
operations
that
also
involve
human
contact
(
e.
g.,
cotton
harvesting
where
module
builders
and
trampers
are
used);
various
operations
with
Christmas
trees
such
as
pruning
or
baling;
and
various
operations
with
nut
production
such
as
sweeping
for
harvest.

°
The
transfer
coefficient
in
Policy
003
for
tree
fruit
thinning
has
been
reduced
since
the
issuance
of
the
policy
from
8000
cm2/
hour
to
3000
cm2/
hour
based
on
a
re­
evaluation
of
the
data
from
the
cited
study
(
i.
e.,
the
change
is
based
on
an
altered
analytical
recovery
correction
factor
that
was
erroneously
used
by
Bayer
in
the
initial
study
report).
This
modification
has
been
made
in
the
tree
fruit
group
and
any
other
scenarios
which
have
used
this
value.
Additionally,
preliminary
data
from
a
biomonitoring
study
of
tree
fruit
thinning
presented
at
the
International
Society
of
Exposure
Analysis
meeting
in
August
2002,
sponsored
by
Bayer
and
conducted
by
Krieger
et
al
from
the
University
of
California
Riverside,
also
supports
use
of
a
transfer
coefficient
of
3000
cm2/
hr
for
tree
fruit
thinners.

°
The
tree
fruit
harvester
transfer
coefficient
used
in
this
assessment
of
1500
cm2/
hr
was
reduced
in
this
assessment
from
a
value
of
3000
cm2/
hr.
This
modification
was
discussed
at
the
Agency's
Science
Advisory
Council
For
Exposure
(
i.
e.,
EXPOSAC)
and
has
been
permanently
incorporated
into
its
Policy
003
for
agricultural
transfer
coefficients.
This
modification
was
made
by
considering
the
results
of
six
different
tree
harvester
studies
conducted/
owned
by
the
Agricultural
Reentry
Task
Force,
two
of
which
evaluated
exposure
to
carbaryl.
A
range
of
crops
was
represented
in
these
data
including
pome
fruit
(
apples),
stone
fruit
(
peaches),
and
citrus.
Other
116
chemistries
which
were
considered
include:
an
organophosphate
insecticide,
a
pyrethroid
insecticide,
and
a
fungicide.

7.2.1
Occupational
Postapplication
Noncancer
Risks
Current
label
requirements
specify
12
hour
REIs.
For
all
but
the
lowest
exposure
scenarios
in
some
crops,
short­
term
MOEs
are
of
concern
(
i.
e.,
less
than
the
required
uncertainty
factor
of
100)
at
the
current
REI.
Generally,
short­
term
MOEs
meet
or
exceed
the
Agency
uncertainty
factor
in
the
range
of
3
to
5
days
for
lower
to
medium
exposure
activities
and
from
8
to
12
days
after
application
in
most
higher
exposure
scenarios.
Intermediate­
term
MOEs
are
not
of
concern
generally
for
low
to
medium
level
exposures
but
are
of
concern
for
higher
level
exposures
such
as
harvesting
in
some
crops.
Chronic
exposures
are
of
concern
for
the
cut
flower
industry
but
not
for
general
greenhouse
and
nursery
production
activities.
Table
29
below
provides
a
summary
of
the
noncancer
risks
that
have
been
calculated
for
each
crop
group
and
each
duration
of
exposure.
The
information
presented
includes
the
short­
term
MOEs
on
the
day
of
application,
the
day
after
application
where
the
short­
term
MOEs
meet
or
exceed
the
target
of
100,
the
intermediate­
term
MOEs
based
on
30
day
average
exposures,
and
chronic
MOEs
also
based
on
30
day
average
exposures
(
only
for
a
limited
number
of
scenarios).

Table
29:
Summary
of
Carbaryl
Noncancer
Postapplication
Worker
Risks
Crop
Group
Result
Type
Exposure
Descriptor
(
See
Appendix
E)

Very
Low
Low
Medium
High
Very
High
Low
Berry
ST
MOE
Day
0
NA
184
NA
49
NA
Days
For
ST
MOE
>
UF
NA
0
NA
4
NA
IT
30
Day
Avg
MOE
NA
991
NA
264
NA
Bunch/
Bundle
ST
MOE
Day
0
NA
411
32
21
NA
Days
For
ST
MOE
>
UF
NA
0
6
8
NA
IT
30
Day
Avg
MOE
NA
2365
182
118
NA
Low
/
Med.
Field/
Row
Crops
ST
MOE
Day
0
NA
982
65
39
NA
Days
For
ST
MOE
>
UF
NA
0
3
5
NA
IT
30
Day
Avg
MOE
NA
5286
352
211
NA
Tall
Field/
Row
Crops
ST
MOE
Day
0
NA
245
61
25
<
1
Days
For
ST
MOE
>
UF
NA
0
4
11
+
30
IT
30
Day
Avg
MOE
NA
970
242
97
6
Cut
Flowers
ST
MOE
Day
0
NA
30
18
11
NA
Days
For
ST
MOE
>
UF
NA
7
9
12
NA
IT
30
Day
Avg
MOE
NA
159
99
57
NA
Chronic
MOE
NA
194
121
69
NA
Sugarcane
ST
MOE
Day
0
NA
NA
55
27
NA
Table
29:
Summary
of
Carbaryl
Noncancer
Postapplication
Worker
Risks
Crop
Group
Result
Type
Exposure
Descriptor
(
See
Appendix
E)

Very
Low
Low
Medium
High
Very
High
117
Days
For
ST
MOE
>
UF
NA
NA
3
7
NA
IT
30
Day
Avg
MOE
NA
NA
315
158
NA
Decid.
Fruit
Trees
ST
MOE
Day
0
1455
146
NA
97
49
Days
For
ST
MOE
>
UF
0
0
NA
1
8
IT
30
Day
Avg
MOE
4450
445
NA
297
148
Evergreen
Fruit
Trees
ST
MOE
Day
0
582
58
39
19
NA
Days
For
ST
MOE
>
UF
0
6
10
17
NA
IT
30
Day
Avg
MOE
1780
178
119
59
NA
Nut
Trees
ST
MOE
Day
0
NA
175
NA
35
NA
Days
For
ST
MOE
>
UF
NA
0
NA
11
NA
IT
30
Day
Avg
MOE
NA
534
NA
107
NA
Turf/
Sod
ST
MOE
Day
0
NA
312
NA
10
NA
Days
For
ST
MOE
>
UF
NA
0
NA
14
NA
IT
30
Day
Avg
MOE
NA
1505
NA
46
NA
Root
Veg.
ST
MOE
Day
0
NA
245
49
29
NA
Days
For
ST
MOE
>
UF
NA
0
4
7
NA
IT
30
Day
Avg
MOE
NA
1322
264
159
NA
Cucurbit
Veg.
ST
MOE
Day
0
NA
147
49
29
NA
Days
For
ST
MOE
>
UF
NA
0
4
7
NA
IT
30
Day
Avg
MOE
NA
793
264
159
NA
Fruiting
Veg.
ST
MOE
Day
0
NA
147
105
74
NA
Days
For
ST
MOE
>
UF
NA
0
0
2
NA
IT
30
Day
Avg
MOE
NA
793
566
396
NA
Brassica
ST
MOE
Day
0
NA
37
18
15
NA
Days
For
ST
MOE
>
UF
NA
6
9
11
NA
IT
30
Day
Avg
MOE
NA
198
99
79
NA
Leafy
Veg.
ST
MOE
Day
0
NA
147
49
29
NA
Days
For
ST
MOE
>
UF
NA
0
4
7
NA
IT
30
Day
Avg
MOE
NA
793
264
159
NA
Stem/
stalk
Veg.
ST
MOE
Day
0
NA
137
82
41
NA
Table
29:
Summary
of
Carbaryl
Noncancer
Postapplication
Worker
Risks
Crop
Group
Result
Type
Exposure
Descriptor
(
See
Appendix
E)

Very
Low
Low
Medium
High
Very
High
118
Days
For
ST
MOE
>
UF
NA
0
1
5
NA
IT
30
Day
Avg
MOE
NA
788
473
236
NA
Vine/
trellis
ST
MOE
Day
0
NA
147
74
15
7
Days
For
ST
MOE
>
UF
NA
0
2
11
14
IT
30
Day
Avg
MOE
NA
793
396
79
40
Nursery/
Ornamentals
ST
MOE
Day
0
NA
669
421
184
NA
Days
For
ST
MOE
>
UF
NA
0
0
0
NA
IT
30
Day
Avg
MOE
NA
3604
2266
991
NA
Chronic
MOE
NA
4399
2765
1210
NA
ST
=
Short­
term,
IT
=
Intermediate­
term,
30
Day
Avg.=
Average
exposure
level
over
30
day
interval.
NA
=
Exposure
descriptor
not
applicable
for
that
crop
group.
UF
=
uncertainty
factor
or
target
MOE
of
100.

7.2.2
Occupational
Postapplication
Exposure
and
Risk
Estimates
for
Cancer
Cancer
risks
for
private
growers
(
i.
e.,
10
exposures/
year)
and
commercial
farmworkers
(
i.
e.,
30
exposures/
year)
were
calculated
for
different
crop
groups
as
described
above
and
summarized
in
Table
30
below.
Current
label
requirements
specify
12
hour
REIs.
For
all
scenarios,
cancer
risks
are
<
1x10­
4
on
the
day
of
application
(
i.
e.,
at
the
current
REI).
Likewise,
cancer
risks
are
<
1x10­
6
on
the
day
of
application
for
most
crop/
activity
scenarios
with
private
growers
and
also
for
low
to
medium
exposures
for
commercial
farmworkers.
In
fact,
risks
for
all
scenarios
were
in
the
10­
6
range
in
all
but
two
scenarios
for
commercial
farmworkers
participating
in
very
high
exposure
activities
(
e.
g.,
sweetcorn
handharvesting)
on
the
day
of
application.
In
these
three
cases,
risks
were
in
the
10­
5
range
on
the
day
of
application.
For
private
growers,
it
takes
approximately
5
days
for
risks
to
decline
to
<
1x10­
6
for
crop/
activity
combinations
that
exceed
1x10­
6
on
the
day
of
application.
For
commercial
farmworkers,
it
takes
approximately
8
days
for
risks
to
reach
the
target
level
of
concern
of
<
1x10­
6.
The
1996
Barolo
memo
which
focused
on
cancer
risk
management
should
be
considered
in
the
interpretation
of
these
results.
Current
label
requirements
appear
to
be
adequate
for
all
postapplication
cancer
risks
if
the
10­
4
range
is
used
for
risk
management.
If
the
10­
6
risk
range
is
considered,
it
also
appears
that
the
current
REI
appears
adequate
to
address
cancer
risks
for
many
crop/
activity
combinations.
However,
for
higher
exposure
situations,
longer
duration
REIs
are
predicted.
In
all
cases,
REIs
predicted
based
on
cancer
risks
are
less
restrictive
or
similar
(
i.
e.,
within
a
day
or
two
for
commercial
farmworkers)
than
those
predicted
based
on
the
noncancer
effects
of
carbaryl.
In
no
cases
do
cancer
risks
indicate
more
restrictive
REIs
than
for
noncancer
risks
calculated
for
the
corresponding
crop/
activity
exposure
scenario.
119
Table
30:
Summary
of
Carbaryl
Cancer
Postapplication
Worker
Risks
Crop
Group
Result
Type
Exposure
Descriptor
(
From
Policy
003/
See
Appendix
E)

Very
Low
Low
Medium
High
Very
High
Low
Berry
Private
Grower
Day
0
Risk
NA
1.7
x
10­
7
NA
6.2x
10­
7
NA
Private
Grower
Days
<
1x10­
6
NA
0
NA
0
NA
Com..
Farmworker
Day
0
Risk
NA
5.0
x
10­
7
NA
1.9x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
NA
4
NA
Bunch/
Bundle
Private
Grower
Day
0
Risk
NA
7.4
x
10­
8
9.6x
10­
7
1.5x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
2
NA
Com..
Farmworker
Day
0
Risk
NA
2.2
x
10­
7
2.9x
10­
6
4.4x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
5
8
NA
Low
/
Med.
Field/
Row
Crops
Private
Grower
Day
0
Risk
NA
3.1x
10­
8
4.7x
10­
7
7.8x
10­
7
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
0
NA
Com..
Farmworker
Day
0
Risk
NA
9.3x
10­
8
1.4x
10­
6
2.3x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
2
5
NA
Tall
Field/
Row
Crops
Private
Grower
Day
0
Risk
NA
1.2
x
10­
7
5.0
x
10­
7
1.2
x
10­
6
2.1
x
10­
5
Private
Grower
Days
<
1x10­
6
NA
0
0
2
23
Com..
Farmworker
Day
0
Risk
NA
3.7
x
10­
7
1.5
x
10­
6
3.7
x
10­
6
8.5
x
10­
5
Com..
Farmworker
Days
<
1x10­
6
NA
0
3
10
31
Cut
Flowers
Private
Grower
Day
0
Risk
NA
1.0
x
10­
6
1.7
x
10­
6
2.9
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
0
3
6
NA
Com..
Farmworker
Day
0
Risk
NA
3.1
x
10­
6
5.0
x
10­
6
8.7
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
6
9
12
NA
Sugarcane
Private
Grower
Day
0
Risk
NA
NA
5.6
x
10­
7
1.1
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
NA
0
1
NA
Com..
Farmworker
Day
0
Risk
NA
NA
1.7
x
10­
6
3.3
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
NA
3
6
NA
Decid.
Fruit
Trees
Private
Grower
Day
0
Risk
2.1
x
10­
8
2.1
x
10­
7
NA
3.1
x
10­
7
6.3
x
10­
7
Private
Grower
Days
<
1x10­
6
0
0
NA
0
0
Com..
Farmworker
Day
0
Risk
6.3
x
10­
8
6.3
x
10­
7
NA
9.4
x
10­
7
1.9
x
10­
6
Com..
Farmworker
Days
<
1x10­
6
0
0
NA
0
6
Table
30:
Summary
of
Carbaryl
Cancer
Postapplication
Worker
Risks
Crop
Group
Result
Type
Exposure
Descriptor
(
From
Policy
003/
See
Appendix
E)

Very
Low
Low
Medium
High
Very
High
120
Evergreen
Fruit
Trees
Private
Grower
Day
0
Risk
5.2
x
10­
8
5.2
x
10­
7
7.8
x
10­
7
1.6
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
0
0
0
5
NA
Com..
Farmworker
Day
0
Risk
1.6
x
10­
7
1.6
x
10­
6
2.4
x
10­
6
4.7
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
0
5
9
16
NA
Nut
Trees
Private
Grower
Day
0
Risk
NA
1.7
x
10­
7
NA
8.7
x
10­
7
NA
Private
Grower
Days
<
1x10­
6
NA
0
NA
0
NA
Com..
Farmworker
Day
0
Risk
NA
5.7
x
10­
7
NA
2.6
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
NA
10
NA
Turf/
Sod
Private
Grower
Day
0
Risk
NA
8.1
x
10­
8
NA
2.7
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
0
NA
2
NA
Com..
Farmworker
Day
0
Risk
NA
2.4
x
10­
7
NA
8.0
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
NA
4
NA
Root
Veg.
Private
Grower
Day
0
Risk
NA
1.2
x
10­
7
6.2
x
10­
7
1.0
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
0
NA
Com..
Farmworker
Day
0
Risk
NA
3.7
x
10­
7
1.9
x
10­
6
3.1
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
4
6
NA
Cucurbit
Veg.
Private
Grower
Day
0
Risk
NA
2.1
x
10­
7
6.2
x
10­
7
1.0
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
0
NA
Com..
Farmworker
Day
0
Risk
NA
6.2
x
10­
7
1.9
x
10­
6
3.1
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
4
6
NA
Fruiting
Veg.
Private
Grower
Day
0
Risk
NA
2.1
x
10­
7
2.9
x
10­
7
4.1
x
10­
7
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
0
NA
Com..
Farmworker
Day
0
Risk
NA
6.2
x
10­
7
8.7
x
10­
7
1.2
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
0
1
NA
Brassica
Private
Grower
Day
0
Risk
NA
8.3
x
10­
7
1.7
x
10­
6
2.1
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
0
3
4
NA
Com..
Farmworker
Day
0
Risk
NA
2.5
x
10­
6
5.0
x
10­
6
6.2
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
5
9
10
NA
Table
30:
Summary
of
Carbaryl
Cancer
Postapplication
Worker
Risks
Crop
Group
Result
Type
Exposure
Descriptor
(
From
Policy
003/
See
Appendix
E)

Very
Low
Low
Medium
High
Very
High
121
Leafy
Veg.
Private
Grower
Day
0
Risk
NA
2.1
x
10­
7
6.2
x
10­
7
1.0
x
10­
6
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
0
NA
Com..
Farmworker
Day
0
Risk
NA
6.2
x
10­
7
1.9
x
10­
6
3.1
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
4
6
NA
Stem/
stalk
Veg.
Private
Grower
Day
0
Risk
NA
2.2
x
10­
7
3.7
x
10­
7
7.4
x
10­
7
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
0
NA
Com..
Farmworker
Day
0
Risk
NA
6.7
x
10­
7
1.1
x
10­
6
2.2
x
10­
6
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
1
4
NA
Vine/
trellis
Private
Grower
Day
0
Risk
NA
2.1
x
10­
7
4.1
x
10­
7
2.1
x
10­
6
4.1
x
10­
6
Private
Grower
Days
<
1x10­
6
NA
0
0
4
8
Com..
Farmworker
Day
0
Risk
NA
6.2
x
10­
7
1.2
x
10­
6
6.2
x
10­
6
1.2
x
10­
5
Com..
Farmworker
Days
<
1x10­
6
NA
0
1
10
13
Nursery/
Ornamentals
Private
Grower
Day
0
Risk
NA
4.5
x
10­
8
7.2
x
10­
8
1.7
x
10­
7
NA
Private
Grower
Days
<
1x10­
6
NA
0
0
0
NA
Com..
Farmworker
Day
0
Risk
NA
1.4
x
10­
7
2.2
x
10­
7
5.0
x
10­
7
NA
Com..
Farmworker
Days
<
1x10­
6
NA
0
0
0
NA
NA
=
Exposure
descriptor
not
applicable
for
that
crop
group.

7.3
Occupational
Risk
Characterization
Characterization
of
the
occupational
risks
is
included
below
for
both
handlers
and
for
postapplication
exposures.

Handlers:
The
occupational
handler
assessment
for
carbaryl
is
complex
in
that
three
different
types
of
noncancer
risk
calculations
were
required
based
on
the
recently
selected
endpoints.
The
durations
of
exposure
that
were
considered
for
noncancer
toxicity
were
short­
term
(#
30
days),
intermediate­
term
(
30
days
up
to
several
months),
and
chronic
(
every
working
day).
A
complete
array
of
calculations
was
completed
for
all
identified
exposure
scenarios
using
the
short­
and
intermediate­
term
endpoints
because
the
Agency
believes
that
carbaryl
uses
fit
the
criteria
for
both
of
these
durations.
The
only
calculations
that
were
completed
using
the
chronic
endpoint
were
limited
and
those
associated
with
the
greenhouse
and
floriculture
industries
where
these
kinds
of
exposures
may
occur.
Cancer
risks
were
also
calculated
using
a
linear,
low­
dose
extrapolation
model
(
i.
e.,
Q1*)
for
both
private
growers
(
i.
e.,
10
application
days
per
year)
and
for
those
who
may
more
actively
use
carbaryl
such
as
a
commercial
applicator
(
i.
e.,
30
application
days
per
year).
Cancer
calculations
were
completed
as
well
for
every
scenario
that
has
been
identified
for
both
private
growers
and
commercial
applicators.
For
all
of
the
122
different
types
of
endpoints
selected
(
except
chronic
where
a
limited
number
of
calculations
were
completed),
the
Agency
identified
exposures
that
fit
into
28
different
scenarios
which
are
defined
based
on
the
equipment
used
to
make
applications
or
the
type
of
formulation
used.
Within
each
of
these
categories,
different
application
rates
and
acres
treated
values
were
considered
to
evaluate
the
broad
range
of
applications
that
may
occur
with
each
kind
of
equipment
(
e.
g.,
a
groundboom
may
be
used
for
turf
or
agriculture).
All
totaled,
140
different
crop/
rate/
acres
combinations
were
considered
within
the
28
scenarios
for
the
short­
and
intermediate­
term
toxicity
categories
plus
4
chronic
crop/
rate/
acre
combinations.
The
overall
result
is
that
4
sets
of
140
calculations
each
(
564
total
calculations)
were
completed
for
occupational
carbaryl
handlers.
Finally,
it
should
be
noted
that
each
calculation
was
completed
at
different
levels
of
personal
protection
to
allow
for
a
more
informed
risk
management
decision.
Even
given
the
scope
of
the
calculations
that
have
already
been
completed,
it
is
likely
that
there
are
some
uses
of
carbaryl
that
have
not
been
quantitatively
addressed
in
this
document
either
through
lack
of
exposure
data
or
other
information
and
because
carbaryl
is
such
a
widely
used
chemical.
These
scenarios
will
be
addressed
by
the
Agency
when
they
are
identified
as
carbaryl
progresses
through
the
reregistration
process.
Readers
are
also
encouraged
to
evaluate
novel
scenarios
by
considering
the
range
of
estimates
already
completed
as
it
is
likely
that
many
uses
could
be
quantitatively
assessed
by
reviewing
those
calculations
as
a
wide
array
of
chemical
use
combinations
and
equipment
types
have
already
been
considered.

The
data
that
were
used
in
the
carbaryl
occupational
handler
risk
assessment
represent
the
best
data
and
approaches
that
are
currently
available.
While
some
of
the
data
which
have
been
used
may
not
be
of
optimal
quality,
they
represent
the
best
available
data
for
the
scenario
in
question.
In
many
cases,
the
Pesticide
Handlers
Exposure
Database
(
PHED)
was
used
to
develop
the
unit
exposure
values.
The
quality
of
the
data
included
in
PHED
vary
widely
from
scenarios
that
meet
guideline
requirements
for
studies
to
others
where
a
limited
number
of
poor
quality
datapoints
are
available.
The
results
for
each
scenario
should
be
reviewed
in
the
context
of
the
quality
of
these
data.
In
addition
to
PHED,
the
Agency
used
a
number
of
studies
to
define
unit
exposure
values.
Generally,
the
quality
of
these
studies
is
excellent.
Most,
except
for
the
trigger
sprayer
data,
are
very
recent
and
based
on
the
newest
analytical
requirements
and
monitoring
techniques.
PHED
unit
exposure
values
represent
a
central
tendency
of
the
data
(
i.
e.,
geometric
mean,
median
or
arithmetic
mean
depending
upon
the
distribution
of
the
data).
As
such,
the
values
based
on
the
recent
studies
also
are
measures
of
central
tendency
(
e.
g.,
the
geometric
means
were
selected
from
each
study
for
assessment
purposes
in
most
cases).
Along
with
the
unit
exposure
values
used
in
the
assessment,
other
inputs
include
application
rates
and
daily
acres
treated
values.
Selected
application
rates
represent
a
range
for
each
major
market
in
which
carbaryl
is
used
including
agriculture,
turf
(
lawncare,
golf
courses,
etc.),
ornamentals,
and
for
wide
area
applications
such
as
mosquito
control.
Many
application
rates
also
represent
maximum
amounts
that
are
allowed
by
the
label
for
certain
settings.
Where
available,
average
use
rates
were
also
used
to
provide
for
a
more
informed
risk
management
decision.
The
application
rates
that
were
selected
for
use
in
the
risk
assessment
were
defined
based
on
labels,
information
provided
by
the
Bayer
at
the
September
24,
1998
SMART
Meeting
for
carbaryl,
and
based
on
various
analyses
of
carbaryl
use
patterns
completed
by
the
Agency's
Biological
and
Economic
Analysis
Division.
The
other
key
input
for
completing
handler
risk
assessments
used
for
defining
how
much
chemical
can
be
used
in
a
day
is
how
much
can
be
treated
in
a
123
day
which
is
generally
expressed
as
the
number
of
acres
treated
per
day.
The
values
that
were
used
for
this
parameter
represent
the
latest
Agency
thinking
on
this
issue.
In
fact,
the
Science
Advisory
Council
For
Exposure
recently
updated
the
policy
for
these
inputs
(
July
2000
Exposure
SAC
Policy
9:
Standard
Values
for
Daily
Acres
Treated
in
Agriculture).
These
most
recent
values
have
been
used
for
the
calculations.

In
addition
to
the
key
sources
of
information
considered
above,
there
are
many
underlying
factors
that
may
impact
the
overall
results
of
a
risk
assessment.
For
example,
the
protection
factors
used
for
adding
additional
levels
of
dermal
and
respiratory
protection
may
impact
the
overall
risk
picture.
The
factors
used
in
this
assessment
by
the
Agency
are
the
ones
that
have
been
used
for
several
years.
Other
such
factors
may
include
the
fact
that
average
application
rates
have
been
generally
used
to
represent
typical
application
rates
to
calculate
ranges
of
risks
when
it
is
clear
that
the
two
values
could
differ
greatly.
The
Agency
has
taken
this
approach
because
the
data
required
to
define
typical
application
rates
within
each
crop
are
generally
unavailable.
There
are
also
exposure
monitoring
issues
that
should
be
considered.
For
example,
in
many
cases
the
data
included
in
PHED
are
based
on
the
use
of
cotton
gloves
for
hand
exposure
monitoring
which
are
thought
by
many
to
overestimate
exposure
because
they
potentially
retain
residues
more
than
human
skin
would
over
time
(
i.
e.,
they
may
act
like
a
sponge
compared
to
the
actual
hand).
A
similar
issue
was
noted
with
the
carbaryl­
specific
dog
grooming
study
that
used
the
handwash
approach
to
monitor
exposure
after
shampooing
several
dogs.
These
intangible
elements
of
the
risk
assessment
reflect
many
of
the
hidden
uncertainties
associated
with
exposure
data.
The
overall
impacts
of
these
uncertainties
is
hard
to
quantify.
The
factor
to
again
consider
is
that
the
Agency
used
the
best
available
data
to
complete
the
risk
assessment
for
carbaryl.
It
should
also
be
noted
that
the
Agency
carefully
considered
comments
received
on
the
previous
assessment
and
has
incorporated
responses
as
appropriate.
Two
key
changes
in
the
assessment
made
as
a
result
of
the
comments
were
the
consideration
of
protective
headgear
for
open
cab
airblast
applicators
and
consideration
of
high
acreage
extrapolation
based
on
a
biomonitoring
study
using
ethoprop
which
was
inconclusive
(
i.
e.,
no
changes
to
the
high
acreage
assessments
were
completed
based
on
this
comment).

In
summary,
the
Agency
believes
that
the
risk
values
presented
in
this
occupational
assessment
represent
the
highest
quality
results
that
could
be
produced
given
the
exposure,
use,
and
toxicology
data
that
are
available.
Certainly
risk
managers
and
other
interested
parties
should
consider
the
quality
of
individual
inputs
when
interpreting
the
results
and
make
decisions
accordingly.
It
is
difficult
to
ascertain
where
on
a
distribution
the
values
which
have
been
calculated
fall
because
the
distributional
data
for
exposure,
application
rates,
acres
treated
and
many
other
parameters
are
unrefined.
The
Agency
does
believe,
however,
that
the
risks
represent
conservative
estimates
of
exposure
because
maximum
application
rates
are
coupled
with
large
acreage
estimates
to
define
risk
estimates
that
likely
fall
in
the
upper
percentiles
of
the
actual
exposure
distributions.
Additionally,
risk
estimates
are
thought
to
be
conservative
even
when
measures
of
central
tendency
are
combined
because
values
that
would
be
considered
to
be
in
the
lower
percentile
aspect
of
any
input
parameter
have
not
been
used
in
the
calculations.

Postapplication:
Like
the
occupational
handler
risk
assessment
discussed
above,
the
postapplication
worker
risk
assessment
for
carbaryl
is
also
complex
in
that
three
different
types
of
noncancer
risk
calculations
were
required
based
on
the
recently
selected
endpoints
along
with
cancer
risk
calculations
using
a
linear,
low­
dose
extrapolation
model.
For
all
of
the
different
types
of
endpoints
selected
(
except
chronic
where
a
limited
number
of
calculations
were
completed),
the
Agency
identified
exposures
that
fit
into
18
different
crop
groups
which
are
defined
essentially
based
on
the
nature
of
the
124
crop
where
a
work
activity
would
take
place.
Within
each
of
these
crop
groups,
ranges
of
transfer
coefficients
were
considered
to
reflect
differences
in
exposures
that
would
be
associated
with
the
variety
of
cultural
practices
that
are
required
to
produce
the
crop/
product.
All
totaled,
56
different
cultural
practices
were
considered
within
the
18
crop
groups
for
each
toxicity
category.
The
overall
result
is
that
4
sets
of
56
calculations
each
(
224
plus
a
few
chronic
values)
were
completed
for
postapplication
workers.
Finally,
it
should
be
noted
that
each
calculation
was
completed
at
different
days
after
application
to
reflect
residue
dissipation
over
time
in
the
environment
and
to
allow
for
a
more
informed
risk
management
decision.
Even
given
the
scope
of
the
calculations
that
have
already
been
completed,
it
is
likely
that
there
are
some
uses
of
carbaryl
that
have
not
been
quantitatively
addressed
in
this
document
either
through
lack
of
exposure
data
or
other
information
and
because
carbaryl
is
such
a
widely
used
chemical.
These
scenarios
will
be
addressed
by
the
Agency
when
they
are
identified
as
carbaryl
progresses
through
the
reregistration
process.
Readers
are
also
encouraged
to
evaluate
novel
scenarios
by
considering
the
range
of
estimates
already
completed
as
it
is
likely
that
many
uses
could
be
quantitatively
assessed
by
reviewing
existing
calculations
as
a
wide
array
of
crop/
activity
combinations
have
already
been
considered.

The
data
that
were
used
in
the
carbaryl
postapplication
worker
risk
assessment
represent
the
best
data
and
approaches
that
are
currently
available.
The
latest
Agency
transfer
coefficient
values
have
been
used
to
complete
this
assessment
including
the
recently
submitted
ARTF
studies
on
greenhouse
workers.
Most
of
the
values
in
the
current
Agency
policy
are
based
on
the
work
of
the
Agricultural
Reentry
Task
Force
(
ARTF)
of
which,
Bayer
is
a
member.
The
current
Agency
policy
is
interim
in
nature
but
represents
all
of
the
data
that
have
been
submitted
by
the
ARTF
and
evaluated
by
the
Agency.
The
work
of
the
ARTF
is
still
ongoing
so
additional
data
may
become
available
to
refine
the
exposure
estimates
as
more
data
are
submitted
to
the
Agency.
Also,
it
is
possible
that
there
are
exposure
scenarios
that
have
not
been
addressed
by
the
Agency
because
the
transfer
coefficient
model
is
not
appropriate
as
there
is
little
or
no
foliar
contact
associated
with
the
activity.
There
are
also
potentially,
partially
mechanized
activities
that
could
lead
to
exposure
where
the
Agency
has
no
information.
These
will
need
to
be
carefully
considered
in
the
reregistration
process.
In
addition
to
the
exposure
inputs
for
specific
activities
(
i.
e.,
transfer
coefficients),
the
Agency
used
4
carbaryl­
specific
DFR
(
Dislodgeable
Foliar
Residue)
dissipation
studies
and
a
single
TTR
(
Turf
Transferable
Residue)
study
to
calculate
risks
for
all
postapplication
workers
in
every
region
in
the
country.
It
is
standard
practice
for
the
Agency
to
use
these
kinds
of
studies
in
this
manner
but
it
is
likely
that
additional
crop­
and
region­
specific
data
could
be
used
to
further
refine
the
risk
assessment.
Several
other
key
pieces
of
data
and
information
were
considered
in
the
development
of
the
postapplication
risk
values
including
use
and
usage
information
and
exposure
frequency
in
the
cancer
risk
assessment.
For
many
agricultural
crops,
the
maximum
application
rate
is
low
(
e.
g.,
1.5
to
2
lb
ai/
acre)
in
many
crops.
As
a
result,
postapplication
risks
were
generally
calculated
at
maximum
rate
levels
because
of
the
already
inherent
complexity
of
the
assessment
and
because
it
is
likely
that
results
may
not
be
extremely
sensitive
to
changes
in
this
value.

In
addition
to
the
key
sources
of
information
considered
above,
there
are
many
underlying
factors
that
may
impact
the
overall
results
of
a
risk
assessment.
For
example,
subtle
differences
between
activities
in
similar
crops
within
each
of
the
18
agronomic
groups
considered
in
the
assessment
may
not
be
accurately
reflected
in
the
current
transfer
coefficient
values.
The
use
of
4
DFR
studies
to
represent
all
crops
and
all
regions
within
the
country
could
lead
to
results
that
do
not
reflect
actual
use
practices
and
conditions
in
some
parts
of
the
country.
Additionally,
the
exposure
frequency
values
that
were
used
for
private
growers
and
professional
farmworkers
tend
to
be
supported
by
available
data
but
could
be
refined
if
data
on
work
patterns
and
regional
carbaryl
use
becomes
available.
As
with
the
handler
125
assessment
above,
the
intangible
elements
reflect
many
of
the
hidden
uncertainties
associated
with
exposure
data.
The
overall
impacts
of
these
uncertainties
is
hard
to
quantify.
The
factor
to
again
consider
is
that
the
Agency
used
the
best
available
data
to
complete
the
risk
assessment
for
carbaryl.

In
summary,
the
Agency
believes
that
the
risk
values
presented
in
this
postapplication
assessment
represent
the
highest
quality
results
that
could
be
produced
given
the
exposure,
use,
and
toxicology
data
that
are
available.
Certainly
risk
managers
and
other
interested
parties
should
consider
the
quality
of
individual
inputs
when
interpreting
the
results
and
make
decisions
accordingly.
It
is
difficult
to
ascertain
where
on
a
distribution
the
values
which
have
been
calculated
fall
because
the
distributional
data
for
exposure,
residue
dissipation
and
many
other
parameters
are
unrefined.
The
Agency
does
believe,
however,
that
the
risks
represent
conservative
estimates
of
exposure
because
maximum
application
rates
are
used
to
define
residue
levels
upon
which
the
risk
calculations
are
based.
Additionally,
risk
estimates
are
thought
to
be
conservative
even
when
measures
of
central
tendency
(
e.
g.,
most
transfer
coefficients
are
thought
to
be
central
tendency)
are
used
because
values
that
would
be
considered
to
be
in
the
lower
percentile
aspect
of
any
input
parameter
have
not
been
used
in
the
calculations.

8.0
HUMAN
AND
DOMESTIC
ANIMAL
INCIDENT
DATA
REVIEW
Data
on
incidents
of
adverse
reactions
in
humans
exposed
to
carbaryl
were
evaluated
from
several
sources,
including
OPP's
Incident
Data
System,
Poison
Control
Centers,
California
Department
of
Pesticide
Regulation,
National
Pesticide
Telecommunications
Network
and
the
open
literature.
The
data
from
the
Incident
Data
System
indicated
that
a
majority
of
cases
from
carbaryl
exposure
involved
dermal
reactions.
A
number
of
cases
involved
asthmatics
and
people
who
experienced
hives
and
other
allergic
type
reactions.
According
to
California
data,
about
half
of
the
cases
involved
skin
and
eye
effects
in
handlers.
About
a
quarter
of
the
skin
reactions
were
due
to
workers
that
were
exposed
to
residues
on
crops.
Reports
from
the
literature
are
very
limited
but
tend
to
support
the
finding
that
carbaryl
has
irritant
properties.

The
Poison
Control
Center
cases
involving
non­
occupational
adults
and
older
children
showed
an
increased
risk
in
five
of
the
six
measures
reported.
These
cases
were
almost
twice
as
likely
to
require
serious
health
care
(
hospitalization
or
treatment
in
a
critical
care
unit)
and
were
two
and
a
half
times
more
likely
to
experience
major
medical
outcome
(
life­
threatening
effects
or
significant
residual
disability)
as
compared
to
other
pesticides.
This
pattern
of
increased
risk
was
not
seen
among
occupational
reports
or
in
young
children.
This
may
mean
careless
handling
by
non­
professionals
is
a
particular
hazard.

Five
case
reports
suggested
that
carbaryl
may
be
a
cause
of
chronic
neurological
or
psychological
problems.
Some
of
these
effects
appear
to
be
consistent
with
those
reported
from
organophosphate
poisoning.
However,
unlike
organophosphates,
no
controlled
studies
have
been
undertaken.
If
such
effects
occur
as
a
result
of
over­
exposure
to
carbaryl,
they
appear
to
be
relatively
rare.
The
effects
reported
among
the
five
case
reports
are
too
inconsistent
to
draw
any
conclusions,
but
do
suggest
the
need
for
further
study.

Carbaryl
appears
capable
of
causing
dermal
and
allergic
type
reactions.
Data
support
the
need
for
personal
protective
equipment
and
eye
protection
for
handlers
for
field
workers
who
may
have
extensive
exposure
to
carbaryl.
Labels
for
products
should
advise
that
carbaryl
can
cause
sensitizing
effects
in
some
people.
126
Based
on
an
evaluation
of
limited
incident
data
on
domestic
animals
in
IDS,
it
is
recommended
that
all
labels
for
carbaryl
products
used
on
cats
contain
the
age
restriction
stated
in
PR
Notice
96­
6
(
should
not
be
used
in
kittens
less
than
12
weeks
of
age).

A
detailed
discussion
of
the
incident
data
is
presented
in
Appendix
2.

9.0
DATA
NEEDS
Toxicology
data
gaps
°
90­
day
inhalation
study
in
rats
with
cholinesterase
measurements
Product
chemistry
data
gaps
°
A
review
of
the
labels
and
supporting
residue
data
indicate
that
several
label
amendments
are
required.
Details
are
provided
in
the
Product
and
Residue
Chemistry
Chapters
(
DP
Barcode:
D240989)
dated
November
14,
2000.

°
The
requirement
for
acceptable
enforcement
methods
which
determine
residues
of
concern
in
plant
and
livestock
commodities
remains
outstanding.

°
The
requirements
for
storage
stability
data
are
not
satisfied
for
purposes
of
reregistration.
Additional
data
are
required
depicting
the
storage
stability
of
carbaryl
per
se
in
an
oilseed,
processed
commodities
of
an
oily
crop,
and
a
dried
fruit
stored
for
up
to
10
months.
In
addition,
the
registrant
is
relying
on
earlier
magnitude
of
the
residue
studies
that
are
not
supported
by
the
existing
storage
stability
data;
therefore,
additional
storage
stability
data
are
required.
The
required
data
must
reflect
storage
intervals
of
18
months
for
alfalfa
commodities,
15
months
for
potatoes,
17
months
for
cottonseed,
22
months
for
wheat
commodities,
and
33
months
for
rangeland
grass.
In
addition,
if
the
registrant
wishes
to
rely
on
the
previously
submitted
sugar
beet
processing
study,
information
pertaining
to
sample
conditions
and
intervals
for
the
study
must
be
submitted.

°
For
the
purpose
of
reregistration,
the
requirements
for
storage
stability
data
for
carbaryl
residues
in
livestock
commodities
are
partially
satisfied.
Additional
information
on
the
storage
intervals
prior
to
analysis
for
metabolite
residues
in
the
cattle
feeding
study
is
required.

°
Separate
tolerances
on
many
commodities
need
to
be
reassigned
concomitant
with
establishing
tolerances
for
the
appropriate
crop
group
and
subgroup.
The
recommended
changes
are
summarized
in
Table
C
under
"
Tolerances
Needed
Under
40
CFR
§
180.169(
a),
crop
group/
subgroup
tolerances"
of
the
Product
and
Residue
Chemistry
Chapters.
127
°
The
data
submitted
are
not
adequate
to
support
the
use
of
granular
(
G)
formulations
of
carbaryl
on
leafy
vegetables.
Residues
of
carbaryl
found
in
leaf
lettuce
were
not
consistent.
Both
samples
of
lettuce
from
the
10%
G
treatment
had
substantially
higher
residues
(
37.01
and
47.22
ppm)
than
one
of
the
samples
treated
with
the
FlC
(
23.25
ppm).
Additionally,
all
residues
were
significantly
above
the
current
tolerance
of
10
ppm
and
all
residue
data
submitted
in
support
of
the
tolerance
in
lettuce
(<
8.85
ppm).
No
explanation
for
the
higher
residues
was
given
by
the
registrant.
The
registrant
may
elect
to
repeat
the
side
by
side
trial
on
leaf
lettuce
again
or
submit
a
rationale
for
the
results
of
the
leaf
lettuce
study.

°
Data
are
required
depicting
residues
of
carbaryl
in/
on
grass
forage
harvested
immediately
(
0­
day)
following
the
last
of
two
applications
of
carbaryl
(
WP
or
FlC)
at
1.5
lb
ai/
A
to
pasture.
A
total
of
12
field
trials
are
required
in
areas
throughout
the
U.
S.

°
Adequate
data
are
available
to
reassess
the
tolerances
for
residues
of
carbaryl
in/
on
dried
beans,
cowpeas,
lentils
and
peas
with
pods.
These
data
support
the
establishment
of
crop
subgroup
tolerances
for
edible­
podded
legume
vegetables
(
6A),
and
for
dried,
shelled
pea
and
bean
except
soybean
(
6C).
However,
additional
residue
data
are
required
if
the
registrant
seeks
tolerances
for
residues
in/
on
succulent,
shelled
pea
and
bean
commodities.
A
total
of
12
tests,
six
tests
each
on
a
succulent,
shelled
cultivar
of
bean
and
garden
pea,
are
required
to
support
a
tolerance
for
residues
in/
on
the
succulent,
shelled
pea
and
bean
crop
subgroup
(
6B).
The
registrant
is
referred
to
OPPTS
GLN
860.1500
for
the
number
and
distribution
of
tests
required.

°
Adequate
data
are
available
to
reassess
the
tolerance
for
wheat
forage
and
straw.
However,
the
Agency
now
considers
wheat
hay
a
significant
RAC
for
feed
purposes
(
OPPTS
GLN
860.1000
Table
1.).
A
full
set
of
20
field
trials
as
specified
in
OPPTS
GLN
860.1500
are
required
depicting
carbaryl
residues
in/
on
wheat
hay.
When
all
the
field
trials
are
complete,
PHIs
and
tolerances
for
hay
based
on
the
field
trial
data
should
be
proposed.
Data
on
wheat
hay
will
be
translatable
to
proso
millet
hay.

°
Adequate
residue
data
are
available
on
olives
provided
that
use
directions
for
olives
are
amended
to
remove
the
statement
allowing
the
use
of
summer
oil
as
an
adjuvant.
Alternatively,
two
additional
field
trials
are
required
supporting
the
use
of
a
carbaryl­
summer
oil
tank
mix.

°
The
registrant
intends
to
support
a
tolerance
for
residues
of
carbaryl
in/
on
imported
pineapples
(
Bayer
personal
communication
with
C.
Olinger,
9/
24/
98
SMART
meeting).
Residue
data
are
required
depicting
residues
in/
on
pineapples
following
application
of
carbaryl
at
the
maximum
use
rate
and
minimum
PHI.
Five
trials
must
be
submitted,
three
from
Costa
Rica
and
two
from
Mexico.

°
Additional
data
are
required
depicting
carbaryl
residues
in/
on
cotton
gin
byproducts
derived
from
cotton
treated
at
the
maximum
labeled
rate
and
harvested
28
days
after
the
final
application
using
commercial
equipment
(
stripper
and
mechanical
picker).
At
least
three
field
trials
representing
each
type
of
harvesting
(
stripper
and
picker)
are
required.
128
°
The
registrant
does
not
intend
to
support
carbaryl
uses
on
avocados,
barley,
maple
sap,
oats,
rye,
and
sweet
sorghum;
however,
IR­
4
has
indicated
(
Correspondence
from
K.
Dorschner,
IR­
4
Project,
9/
15/
94)
that
they
may
fulfill
the
residue
data
requirements
for
some
of
these
commodities.
These
data
have
not
been
submitted.

°
The
reregistration
requirements
for
magnitude
of
the
residue
in
livestock
commodities
are
not
fulfilled.
Additional
data
are
required
to
support
dermal
and
poultry
house
uses.

Occupational/
Residential
Exposure
Data
Gaps
Residential
Exposure
°
For
the
postapplication
risk
assessments,
there
are
no
data
on
the
amount
of
residues
transferrable
from
treated
pets
to
humans
except
for
a
low
quality
study
that
used
collars.
This
study
was
used
in
the
assessment
but
should
be
considered
in
context.
Additional
data
for
dust
and
liquid
pet
products
would
help
refine
the
assessment.
Residue
data
on
turf
specifically
focused
on
hand­
tomouth
and
object­
to­
mouth
toddler
exposures
would
also
help
to
refine
those
assessments.

Occupational
Exposure
°
For
the
occupational
handler
risk
assessments,
several
exposure
data
gaps
were
identified,
including:
dust
use
for
animal
grooming
and
in
agriculture;
various
specialized
hand
equipment
application
methods
(
e.
g.,
powered
backpack,
power
hand
fogger,
and
tree
injection);
and
nursery
operations
such
as
seedling
dips.

°
For
occupational
postapplication
risk
assessments,
several
data
gaps
exist,
such
as
an
incomplete
dislodgeable
foliar
residue
database
and
a
lack
of
exposure
data
on
partially
mechanized
cultural
practices
where
there
is
a
potential
for
exposure.

°
There
are
also
many
kinds
of
mechanized
activities
that
do
not
involve
foliar
contact
that
have
not
been
addressed
in
this
risk
assessment.
The
scenarios
include:
transplanting
many
crops
including
in
the
ornamental
and
forestry
industry;
thinning
some
crops
such
as
hops;
some
partially
mechanized
operations
that
also
involve
human
contact
(
e.
g.,
cotton
harvesting
where
module
builders
and
trampers
are
used);
hand
weeding
some
crops
such
as
wheat;
various
operations
with
Christmas
trees
such
as
pruning
or
baling;
and
various
operations
with
nut
production
such
as
sweeping
for
harvest.
APPENDIX
1:
Toxicology
Profile
Appendix
1/
Table
1:
Toxicology
Profile
of
Carbaryl
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.3100
90­
Day
oral
toxicity
rodents
N/
A
870.3150
90­
Day
oral
toxicity
in
nonrodents
N/
A
870.3200
21/
28­
Day
dermal
toxicity
with
technical
carbaryl
45630601(
2002)
acceptable/
nonguideline
0,
20,
50,
100
mg/
kg/
day
systemic
NOAEL
=
20
mg/
kg/
day
systemic
LOAEL
=
50
mg/
kg/
day
based
on
decreased
RBC
cholinesterase
in
males
and
females
and
brain
cholinesterase
in
males
dermal
NOAEL
=
100
mg/
kg/
day
dermal
LOAEL
not
established
870.3200
21/
28­
Day
dermal
toxicity
with
Sevin
®
XLR
Plus
(
44.82%
a.
i.)
45630602
(
2002)
unacceptable/
nonguideline
0,
20,
50,
100
mcL/
kg/
day
(
0,
9.6,
24,
48
mg/
kg/
day)
systemic
NOAEL
=
50
mcL/
kg/
day
(
24
mg/
kg/
day)
systemic
LOAEL
=
100
mcL/
kg/
day
(
48
mg/
kg/
day)
based
on
decreased
body
weight
gain
dermal
NOAEL
=
100
mcL/
kg/
day
(
48
mg/
kg/
day)
dermal
LOAEL
not
established
870.3200
21/
28­
Day
dermal
toxicity
with
Sevin
®
80S
(
80.07%
a.
i.)
45630603
(
2002)
unacceptable/
nonguideline
0,
20,
50,
100
mg/
kg/
day
systemic
NOAEL
=
20
mg/
kg/
day
systemic
LOAEL
=
50
mg/
kg/
day
based
on
decreased
RBC
cholinesterase
in
males
and
females
dermal
NOAEL
=
100
mg/
kg/
day
dermal
LOAEL
not
established
870.3250
90­
Day
dermal
toxicity
N/
A
870.3465
90­
Day
inhalation
toxicity
N/
A
870.3700a
Prenatal
developmental
in
rats
44732901
(
1998)
acceptable/
guideline
0,
1,
4,
30
mg/
kg/
day
(
oral
gavage)
Maternal
NOAEL
=
4
mg/
kg/
day
LOAEL
=
30
mg/
kg/
day
based
on
clinical
signs,
decreased
body
weight
gain
(
BWG)
and
food
consumption
Developmental
NOAEL
=
4
mg/
kg/
day
LOAEL
=
30
mg/
kg/
day
based
on
decreased
fetal
body
weight
and
incomplete
ossification
of
multiple
bones
870.3700b
Prenatal
developmental
in
rabbits
44904202
(
1999)
Acceptable/
guideline
0,
5,
50,
150
mg/
kg/
day
(
oral
gavage)
Maternal
NOAEL
=
5
mg/
kg/
day
LOAEL
=
50
mg/
kg/
day
based
on
decreased
BWG
and
plasma
cholinesterase
inhibition
(
ChEI)
Developmental
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
decreased
fetal
weight
Appendix
1/
Table
1:
Toxicology
Profile
of
Carbaryl
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.3800
Reproduction
and
fertility
effects
45448101
(
2001)
acceptable/
guideline
0,
75,
300,
1500
ppm
(
4.67,
31.34,
and
92.43
mg/
kg/
day
for
F0
males;
0,
5.56,
36.32,
and
110.78
mg/
kg/
day
for
F0
females;
0,
5.79,
23.49,
and
124.33
mg/
kg/
day
for
F1
males;
and
0,
6.41,
26.91,
and
135.54
mg/
kg/
day
for
F1
females
averaged
over
the
premating
period)
Parental
NOAEL
=
300
ppm
(
23.49­
31.34
mg/
kg/
day
for
males
and
26.91­
36.32
mg/
kg/
day
for
females)
Parental
LOAEL
=
1500
ppm
(
92.43­
124.33
mg/
kg/
day
for
males
and
110.78­
135.54
mg/
kg/
day
for
females)
based
on
decreased
body
weight,
weight
gain,
and
feed
consumption
Reproductive
toxicity
NOAEL
is
$
1500
ppm
(
92.43­
124.33
mg/
kg/
day
for
males
and
110.78­
135.54
mg/
kg/
day
for
females)
Reproductive
toxicity
LOAEL
not
be
established
Offspring
NOAEL
=
75
ppm
(
4.67­
5.79
mg/
kg/
day
for
males
and
5.56­
6.41
mg/
kg/
day
for
females).
Offspring
LOAEL
=
300
ppm
(
23.49­
31.34
mg/
kg/
day
for
males
and
26.91­
36.32
mg/
kg/
day
for
females)
based
on
increased
numbers
of
F2
pups
with
no
milk
in
the
stomach
and
decreased
pup
survival.

870.4100a
Chronic
toxicity
in
rodents
N/
A
870.4100b
Chronic
toxicity
in
dogs
40166701
(
1987)
0,
125,
400,
1250
ppm
(
0,
3.1,
10,
31.3
mg/
kg/
day)

42022801
(
1991)
0,
20,
45,
125
ppm
(
5
weeks)
(
M:
0,
0.59,
1.43,
3.83;
F:
0,
0,64,
1.54,
4.11
mg/
kg/
day)
Together,
the
studies
are
Acceptable/
guideline
MRID
40166701:
NOAEL
=
not
established
in
females
LOAEL
=
125
ppm
based
based
on
plasma
and
brain
ChEI
MRID
42022801:
NOAEL
=
45
ppm
in
males
LOAEL
=
125
ppm
in
males
based
on
plasma
ChEI
870.4200
Carcinogenicity
in
mice
42786901
(
1993)
Acceptable/
guideline
0,
100,
1000
or
8000
ppm
(
M:
0,
14.73,
145.99,
1248.93
mg/
kg/
day;
F:
0,
18.11,
180.86,
1440.62)
systemic
LOAEL
=
1000
ppm
based
on
increased
intracytoplasmic
droplets
in
bladder
in
males
and
females,
chronic
progressive
nephropathy
in
males;
NOAEL
=
100
ppm
RBC
ChEI
LOAEL
for
males
=
1000
ppm
,
for
females
=
8000
ppm;
NOAEL
=
100
ppm
for
males,
1000
ppm
for
females
plasma
ChEI
for
males
and
females
LOAEL
>
8000
ppm;
NOAEL
$
8000
ppm
brain
ChEI
for
males
and
females
LOAEL
=
8000
ppm;
NOAEL
=
1000
ppm
increase
in
vascular
tumors
in
all
treated
males
and
in
females
at
8000
ppm
increase
in
adenomas,
multiple
adenomas,
carcinomas
of
kidney
in
males
at
8000
ppm
increase
in
hepatic
neoplasms
(
adenomas,
carcinomas,
one
hepatoblastoma)
in
females
at
8000
ppm
Appendix
1/
Table
1:
Toxicology
Profile
of
Carbaryl
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.4300
Chronic
Toxicity/
Carcinogenicity
in
rats
42918801
(
1993)
Acceptable/
guideline
0,
250,
1500
&
7500
ppm
(
M:
0,
10,
60.2,
349.5
mg/
kg/
day;
F:
0,
12.6,
78.6,
484.6
mg/
kg/
day)
systemic
LOAEL
=
1500
ppm
in
females
based
on
decreased
BW
and
BWG;
7500
ppm
in
males
based
on
increased
clinical
signs,
decreased
BW,
BWG
and
food
consumption,
increase
in
cataracts,
clinical
pathology
changes,
organ
weight
changes,
nonneoplastic
changes;
NOAEL
=
250
ppm
in
females
and
1500
ppm
in
males
plasma
ChEI
LOAEL
=
7500
ppm
in
males
and
females;
NOAEL
=
1500
ppm
RBC
ChEI
LOAEL
=
1500
ppm
in
males
and
females;
NOEL
=
250
ppm
brain
ChEI
LOAEL
=
7500
ppm
in
males
and
females;
NOEL
=
1500
ppm
at
7500
ppm,
increase
in
liver
adenomas
in
females,
increase
in
benign
transitional
cell
papillomas
and
transitional
cell
carcinomas
in
males
and
females,
transitional
cell
carcinoma
in
kidney
of
one
male,
increase
in
benign
thyroid
follicular
cell
adenomas
in
males,
follicular
cell
carcinoma
in
one
male
Bacterial
reverse
mutation
test
870.5100
41370303
(
1989)
Acceptable/
guideline
5­
1000
ug/
plate
No
evidence
of
mutagenicity
in
strains
TA1535,
TA
1537,
TA1538,
TA98
and
TA100
with
and
without
metabolic
activation
In
vitro
mammalian
chromosome
aberration
test
(
Chinese
hamster
ovary
cells)
870.5385
41370304
(
1989)
Acceptable/
guideline
without
S9
activation:
5­
100
ug/
mL,
harvest
at
20
hrs.;
with
S9
activation:
25­
300
ug/
mL,
harvest
at
30
hrs
Increase
in
chromosome
aberrations
with
S9
activation
In
vitro
mammalian
chromosome
aberration
test
870.5385
41370302;
41420201
(
1989)
Unacceptable/
guideline
S9
activation:
1­
300
ug/
mL
in
3
trials;
without
S9
activation:
1­
300
ug/
mL
in
2
trials
Results
provide
no
clear
indication
of
a
mutagenic
response,
however
study
had
several
deficiencies
Mammalian
erythrocyte
micronucleus
test
870.
5395
44069301
(
1996)
Unacceptable/
guideline
single
oral
gavage
dose
of
50,
100,
200
mg/
kg
Carbaryl
did
not
induce
a
clastogenic
or
aneugenic
effect,
however
there
was
no
convincing
evidence
that
MTD
was
achieved
Unscheduled
DNA
synthesis
870.5550
41370301;
41810601
(
1989)
Acceptable/
guideline
0.5
­
25.0
ug/
mL
Negative
870.6200a
Acute
neurotoxicity
screening
battery
in
rats
MRID:
43845201­
43845204
(
1995)
Acceptable/
guideline
0,
10,
50,
125
mg/
kg
(
oral
gavage)
Separate
study
for
ChEI:
0,
10,
30,
50
mg/
kg;
ChEI
done
1,
8,
24,
48
hrs
postdosing
Systemic
LOAEL
=
10
mg/
kg
based
on
decreased
RBC,
plasma,
blood,
brain
ChEI;
NOAEL
<
10
mg/
kg
Appendix
1/
Table
1:
Toxicology
Profile
of
Carbaryl
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.6200b
Subchronic
neurotoxicity
screening
battery
in
rats
MRID:
44122601
(
1996)
Acceptable/
guideline
0,
1,
10,
30
mg/
kg/
day
(
oral
gavage)
LOAEL
for
neurotoxicity
=
10
mg/
kg/
day
based
on
increased
FOB
changes;
NOAEL
=
1
mg/
kg/
day
LOAEL
for
ChEI
=
10
mg/
kg/
day
based
on
decreased
plasma,
blood,
RBC,
brain
ChEI;
NOAEL
=
1
mg/
kg/
day
870.6300
Developmental
neurotoxicity
in
rats
44393701
(
1997)
Acceptable/
guideline
0,
0.1,
1.0,
10
mg/
kg
(
oral
gavage)
Maternal
NOAEL
=
1.0
mg/
kg/
day
LOAEL
=
10
mg/
kg/
day
based
on
decreased
BWG;
FOB
changes;
RBC,
plasma,
whole
blood,
brain
ChEI
Offspring
tentative
NOAEL
=
1.0
mg/
kg/
day
tentative
LOAEL
=
10
mg/
kg/
day
based
on
alterations
in
morphometric
measurements
(
measurements
were
not
done
at
lower
doses)

870.7485
Metabolism
and
pharmacokinetics
in
rats
43332101
(
1994)
Acceptable/
guideline
1
mg/
kg
(
single
and
repeated
oral
doses;
intravenous
dose)
and
50
mg/
kg
(
single
oral
dose)
Absorption
was
complete
at
all
doses.
At
168
hrs.,
post­
dose,
negligible
percentages
of
dose
in
any
tissues.
Kidney
and
blood
contained
highest
concentrations
of
radioactivity.
Excretion
mostly
through
urine.
A
metabolic
scheme
with
conjugated
and
non­
conjugated
metabolites
was
proposed.

870.7485
Metabolism
and
pharmacokinetics
in
rats
44402501
(
1997)
Acceptable/
nonguideline
50
mg/
kg
(
single
oral
radiolabeled
dose);
daily
oral
radiolabeled
dose
of
2
mg/
kg
for
7
days
followed
by
83
daily
unlabeled
doses
of
0,
250,
1500
or
7500
ppm;
males
only
In
all
dosing
regimens,
urinary
and
fecal
excretion
was
93­
103%
of
administered
dose
and
tissue
levels
of
radioactivity
were
minimal
at
168
hrs.
post­
dosing.
Two
major
metabolites
in
tissues
at
6
hrs.
post­
dosing
were
naphthyl
sulfate
and
naphthyl
glucuronide,
however
quantitation
was
not
possible.
A
total
of
23
and
20
components
were
identified
in
the
urine
and
feces,
respectively.
The
sulfate
conjugation
pathway
appears
to
be
saturable
following
a
83­
day
feeding
at
7500
ppm.
BW
and
food
consumption
were
decreased
at
7500
ppm.
Increases
in
kidney,
spleen
and
thyroid
weights
were
observed
at
1500
and
7500
ppm.
Non­
neoplastic
changes
in
liver,
thyroids
and
kidneys
were
observed
at
7500
ppm.

870.7600
Dermal
penetration
in
rats
43552901
(
1995)
43.9%
a.
i.
Acceptable
35.6,
403,
3450
ug/
cm2
%
absorbed
at
10
hrs.:
12.7,
7.44
and
1.93
at
35.6,
403
and
3450
ug/
cm2,
respectively
870.7600
Dermal
penetration
in
rats
43339701
(
1994)
80.1%
a.
i.
Acceptable
63,
626,
3410
ug/
cm2
%
absorbed
at
10
hrs:
8.90,
0.62
and
0.48
at
63,
626
and
3410
ug/
cm2,
respectively
Special
studies
in
mice
43282201
(
1994)
Acceptable/
nonguideline
male
mice:
single
radiolabeled
dose
of
75
mg/
kg;
pretreatment
with
8000
ppm
unlabeled
carbaryl
for
2
wks.,
then
single
radiolabeled
dose
of
75
mg/
kg
Negative
for
DNA
binding
in
liver
Appendix
1/
Table
1:
Toxicology
Profile
of
Carbaryl
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
Special
studies
in
mice
43832601
(
1994)
Acceptable/
nonguideline
continuation
of
MRID
43282201
in
liver
from
mice
treated
at
8000
ppm,
increase
in
microsomal
protein,
cytochrome
P450,
ethoxyresorufin
O­
deethylase,
pentoxyresorufin
O­
depentylase,
and
testosterone
hydrolases
indicates
phenobarbital
type
of
induction
of
metabolizing
enzymes
Special
study
in
mice
45281801,
45281802,
45236603
(
1998­
1999)
Acceptable/
nonguideline
0,
10,
30,
100,
300,
1000
and
4000
ppm
(
0,
1.8,
5.2,
17.5,
51.2,
164.5
and
716.6
mg/
kg/
day)
There
was
no
evidence
of
neoplastic
or
preneoplastic
changes
in
vascular
tissue
in
heterozygous
p53­
deficient
male
mice
treated
with
carbaryl
for
six
months.

N/
A
Not
Available
APPENDIX
2:
Incident
Review
Conclusions/
Recommendations
Based
on
Incident
Review
Data
on
incidents
of
adverse
reactions
in
humans
exposed
to
carbaryl
were
evaluated
from
several
sources,
including
OPP's
Incident
Data
System,
Poison
Control
Centers,
California
Department
of
Pesticide
Regulation,
National
Pesticide
Telecommunications
Network
and
the
open
literature.
The
data
from
the
Incident
Data
System
indicated
that
a
majority
of
cases
from
carbaryl
exposure
involved
dermal
reactions.
A
number
of
cases
involved
asthmatics
and
people
who
experienced
hives
and
other
allergic
type
reactions.
According
to
California
data,
about
half
of
the
cases
involved
skin
and
eye
effects
in
handlers.
About
a
quarter
of
the
skin
reactions
were
due
to
workers
that
were
exposed
to
residues
on
crops.
Reports
from
the
literature
are
very
limited
but
tend
to
support
the
finding
that
carbaryl
has
irritant
properties.

The
Poison
Control
Center
cases
involving
non­
occupational
adults
and
older
children
showed
an
increased
risk
in
five
of
the
six
measures
reported.
These
cases
were
almost
twice
as
likely
to
require
serious
health
care
(
hospitalization
or
treatment
in
a
critical
care
unit)
and
were
two
and
a
half
times
more
likely
to
experience
major
medical
outcome
(
life­
threatening
effects
or
significant
residual
disability)
as
compared
to
other
pesticides.
This
pattern
of
increased
risk
was
not
seen
among
occupational
reports
or
in
young
children.
This
may
mean
careless
handling
by
non­
professionals
is
a
particular
hazard.

Five
case
reports
suggested
that
carbaryl
may
be
a
cause
of
chronic
neurological
or
psychological
problems.
Some
of
these
effects
appear
to
be
consistent
with
those
reported
from
organophosphate
poisoning.
However,
unlike
organophosphates,
no
controlled
studies
have
been
undertaken.
If
such
effects
occur
as
a
result
of
over­
exposure
to
carbaryl,
they
appear
to
be
relatively
rare.
The
effects
reported
among
the
five
case
reports
are
too
inconsistent
to
draw
any
conclusions,
but
do
suggest
the
need
for
further
study.

Carbaryl
appears
capable
of
causing
dermal
and
allergic
type
reactions.
Data
support
the
need
for
personal
protective
equipment
and
eye
protection
for
handlers
for
field
workers
who
may
have
extensive
exposure
to
carbaryl.
Labels
for
products
should
advise
that
carbaryl
can
cause
sensitizing
effects
in
some
people.

Based
on
an
evaluation
of
limited
incident
data
on
domestic
animals
in
IDS,
it
is
recommended
that
all
labels
for
carbaryl
products
used
on
cats
contain
the
age
restriction
stated
in
PR
Notice
96­
6
(
should
not
be
used
in
kittens
less
than
12
weeks
of
age).

A
detailed
discussion
of
the
incident
data
is
presented
below.

Human
Incident
Data
Review
A
review
of
the
human
incident
data
on
carbaryl
was
prepared
by
Dr.
Jerome
Blondell
and
Ms.
Monica
Spann
(
D267127
dated
July
17,
2000).

The
following
data
bases
were
consulted
for
the
poisoning
incident
data
on
the
active
ingredient
Carbaryl
(
PC
Code:
056801):
1)
OPP
Incident
Data
System
(
IDS)
­
reports
of
incidents
from
various
sources,
including
registrants,
other
federal
and
state
health
and
environmental
agencies
and
individual
consumers,
submitted
to
OPP
since
1992.

2)
Poison
Control
Centers
­
as
the
result
of
a
data
purchase
by
EPA,
OPP
received
Poison
Control
Center
data
covering
the
years
1993
through
1998
for
all
pesticides.
Most
of
the
national
Poison
Control
Centers
(
PCCs)
participate
in
a
national
data
collection
system,
the
Toxic
Exposure
Surveillance
System
which
obtains
data
from
about
65­
70
centers
at
hospitals
and
universities.

3)
California
Department
of
Pesticide
Regulation
­
California
has
collected
uniform
data
on
suspected
pesticide
poisonings
since
1982.
Physicians
are
required,
by
statute,
to
report
to
their
local
health
officer
all
occurrences
of
illness
suspected
of
being
related
to
exposure
to
pesticides.

4)
National
Pesticide
Telecommunications
Network
(
NPTN)
­
NPTN
is
a
toll­
free
information
service
supported
by
OPP.
A
ranking
of
the
top
200
active
ingredients
for
which
telephone
calls
were
received
during
calendar
years
1984­
1991
and
1995­
1999
has
been
prepared
for
the
categories
human
incidents,
animal
incidents,
calls
for
information,
and
others.

Incident
Data
System
There
were
approximately
500
reports
in
IDS
concerning
exposure
of
humans
to
carbaryl.
At
least
380
cases
were
considered
minor
(
minimal
symptoms
with
no
residual
disability)
and
were
not
included
in
the
review.
The
most
frequently
reported
symptoms
were
of
a
dermatological
nature,
either
dermal
irritation
or
possibly
a
dermal
manifestation
of
an
allergic
response
(
e.
g.,
hives,
welts,
rash,
etc.).
Clinical
signs
or
symptoms
less
frequently
reported
were
nausea,
vomiting,
diarrhea,
respiratory
irritation
and
difficulty
breathing.
Most
of
the
incidents
were
associated
with
dermal
exposure;
however,
a
few
resulted
after
inhalation
of
the
product.
There
was
one
report
of
an
attempted
suicide.
In
1993,
a
21­
year
old
man
ingested
about
75
ml
of
Beetle
Bait
(
21.3%
carbaryl,
Registration
Number
869­
134).
No
information
on
the
symptoms
or
outcome
of
the
case
were
provided.
There
was
also
one
death.
In
1996,
a
woman
with
a
history
of
chronic
asthma
experienced
shock
and
severe
respiratory
distress
after
she
used
Mycodex
Pet
Shampoo
(
0.5%
carbaryl,
Registration
Number
2097­
8)
on
her
dog.
She
was
hospitalized
but
went
into
a
coma
and
died
five
days
later
(
IDS
3694­
1).

Poison
Control
Center
(
PCC)
Data
­
1993
through
1998
The
PCC
data
base
for
1993
through
1998
contained
174
cases
involving
occupational
exposures
in
adults
and
older
children
(
outcome
determined
in
90
cases),
3033
nonoccupational
exposures
in
adults
and
older
children
(
outcome
determined
in
1351
cases)
and
2147
exposures
in
children
under
the
age
of
six
(
outcome
determined
in
1248
cases).
Cases
involving
exposures
to
multiple
products
were
excluded.
The
data
from
cases
in
which
the
outcome
was
determined
were
compared
to
all
other
pesticides
using
six
measures:
percent
with
symptoms,
percent
with
moderate
or
more
severe
outcome,
percent
with
life­
threatening
or
fatal
outcome,
percent
of
exposed
cases
seen
in
a
health
care
facility,
percent
hospitalized
and
percent
seen
in
an
intensive
care
facility.

For
occupational
cases,
carbaryl
appears
to
be
somewhat
less
hazardous
than
all
pesticides
combined,
as
determined
by
five
of
the
six
measures
reported.
Cases
involving
non­
occupational
adults
and
older
children
showed
an
increased
risk
in
five
of
the
six
measures
reported.
In
particular
these
non­
occupational
cases
were
nearly
twice
as
likely
to
require
serious
health
care
(
hospitalization
or
treatment
in
a
critical
care
unit)
and
were
2.5
times
more
likely
to
experience
major
medical
outcome
(
life­
threatening
effects
or
significant
residual
disability).
These
data
suggest
that
some
consumers
are
using
this
chemical
in
a
careless
manner.
For
cases
involving
children
under
six
years
of
age,
carbaryl
has
a
similar
hazard
profile
to
all
other
pesticides.

California
Data
­
1982
through
1996
Detailed
descriptions
of
226
cases
submitted
to
the
California
Pesticide
Illness
Surveillance
Program
(
1982­
1996)
were
reviewed.
In
90
of
these
cases,
carbaryl
was
used
alone
or
was
judged
to
be
responsible
for
the
health
effects.
Only
cases
with
a
definite,
probable
or
possible
relationship
were
reviewed.
Carbaryl
ranked
37th
as
a
cause
of
systemic
poisoning
in
California.
The
number
of
reports
from
California
declined
by
over
half
from
the
first
five
years
of
the
reporting
period
(
1982­
1986)
to
the
last
five
years
(
1992­
1996).
It
is
difficult
to
determine
whether
some
of
this
decline
might
be
related
to
a
decrease
in
usage
because
the
method
of
collecting
use
information
changed
after
1989.
Of
the
90
persons
reported
to
have
illnesses,
a
total
of
43
(
48%)
had
systemic
illnesses,
20
(
22%)
had
eye
irritation,
21
(
23%)
had
skin
irritation,
1(
1%)
had
respiratory
illness
and
5
(
6%)
had
a
combination
of
effects.
A
total
of
26
workers
were
disabled
(
took
time
off
work,
1
for
more
than
10
days)
as
the
result
of
carbaryl
exposure.
Seven
required
hospitalization
(
1­
5
days).
Applicators
were
associated
with
the
majority
of
the
exposures.
Clinical
signs/
symptoms
in
these
workers
included
nausea,
vomiting,
skin
rashes,
sore
throat,
lip
swelling,
chemical
conjunctivitis,
dizziness,
eye
irritation,
contact
dermatitis,
blurry
vision,
chest
pains,
and
several
other
symptoms.

National
Pesticide
Telecommunications
Network
On
the
list
of
the
top
200
chemicals
for
which
NPTN
received
calls
from
1984­
1991
inclusively,
carbaryl
was
ranked
5th
with
503
incidents
in
humans
reported
and
85
incidents
in
animals
(
mostly
pets).
For
the
years
1995
through
1998,
carbaryl's
rank
ranged
from
7th
to
12th
with
110
incidents
in
humans
reported
and
26
incidents
in
animals.
Most
of
the
decline
in
reported
human
cases
from
the
earlier
time
period
is
due
to
the
reduced
level
of
incident
reporting
overall.
However,
even
taking
this
into
account,
there
does
appear
to
be
some
reduction
in
carbaryl
incidents
which
is
also
reflected
in
the
lower
rankings
reported
for
the
later
years
(
1995­
1998).

Literature
Summary
Thirteen
epidemiological
studies/
case
reports
from
the
open
literature
were
reviewed.
Five
case
reports
suggested
that
carbaryl
may
cause
long­
term
neurological
or
11Branch
RA,
Jacqz
E
(
1986).
Is
carbaryl
as
safe
as
its
reputation?
Does
it
have
a
potential
for
causing
chronic
neurotoxicity
in
humans?.
The
American
Journal
of
Medicine
80(
4):
659­
664.

12Brewer
B
(
2000).
A
rare
cause
of
acute
confusional
state
(
Letter
to
the
Editor).
Journal
of
Accidental
Emergency
Medicine
17(
1):
77.

13Devinsky
O,
Kernan
J,
Bear
DM
(
1992).
Aggressive
behavior
following
exposure
to
cholinesterase
inhibitors.
Journal
of
Neuropsychiatry
4(
2):
189­
194.

14Dickoff
DJ,
Gerber
O,
Turovsky
Z
(
1987).
Delayed
neurotoxicity
after
ingestion
of
carbamate
pesticide.
Neurology
37(
7):
1229­
1231.

15Wiener
PK,
Young
RC
(
1995).
Late­
onset
psychotic
depression
associated
with
carbaryl
exposure.
American
Journal
of
Psychiatry152(
4):
646­
647.

16Savitz
DA,
Arbuckle
T,
Kaczor
D,
Curtis
KM.
(
1997).
Male
pesticide
exposure
and
pregnancy
outcome.
American
Journal
of
Epidemiology
146(
12):
1025­
1036.

17Whorton
DM,
Avashia
BH,
Hull
EQ.
(
1979).
Testicular
function
among
carbaryl­
exposed
employees.
Journal
of
Toxicology
and
Environmental
Health
5:
929­
941.

18
Wyrobek
AJ,
Watchmaker
G,
Gordon
L,
Wong
K,
Moore
D
2d,
Whorton
D
(
1981).
Sperm
shape
abnormalities
in
carbaryl­
exposed
employees.
Environmental
Health
Perspectives
40:
255­
265.
psychologicalproblems.
11,12,13,14,15
Two
of
these
cases
involved
attempted
suicides
in
which
large
doses
of
carbaryl­
containing
products
were
ingested.
Some
of
the
effects
from
carbaryl
exposure
are
consistent
with
those
reported
from
organophosphate
poisoning.
However,
no
controlled
studies
have
been
conducted.
If
such
effects
occur
as
a
result
of
carbaryl
overexposure
they
appear
to
be
relatively
rare.
The
effects
observed
in
the
case
reports
are
too
inconsistent
to
draw
any
conclusions,
but
do
suggest
the
need
for
further
study.

Other
literature
articles
concerned
epidemiology
studies
to
evaluate
the
effects
of
pesticides
on
reproduction.
In
the
1979
Ontario
Farm
Family
Study
by
Savitz
et
al16,
the
effects
of
activities
and
specific
pesticides
on
male
farmer's
fertility
were
considered.
The
results
suggested
that
thiocarbamates,
carbaryl
and
other
pesticides
were
most
strongly
associated
with
miscarriage.
The
adjusted
odds
ratio
for
carbaryl
used
on
crops
was
2.1
with
a
95
percent
confidence
interval
of
1.1
to
4.1
(
borderline
significance).
Use
of
carbaryl
in
the
yard
was
not
associated
with
a
significantly
increased
risk
of
miscarriage
and
carbaryl
was
not
a
significant
risk
factor
for
preterm
delivery
or
small
for
gestational
age
births.
In
a
1979
study
of
male
workers
who
produced
and
packaged
carbaryl,
Whorton
et
al17
concluded
that
there
was
no
evidence
of
sperm
count
suppression
resulting
from
exposure
to
the
chemical.
Whorton
et
al.
(
1979)
and
Wyrobek
et
al18
(
1981)
used
the
same
cohort
in
their
studies
to
determine
the
effects
on
fertility
by
checking
for
infertile
marriages
and
by
measuring
sperm
counts
and
serum
gonadotropins.
The
carbaryl­
exposed
group
included
nearly
three
times
as
many
oligospermic
men
as
the
control
group.
Wyrobek
et
al.
(
1981)
concluded
there
was
a
non­
dose
related,
significant
elevation
in
sperm
head
abnormalities
compared
to
controls,
that
may
not
be
reversible.
Both
of
the
studies
had
low
participation
rates,
relied
on
self­
reporting
of
exposure
levels,
and
used
less
than
ideal
control
groups.
19Senthilselvan
A,
McDuffie
HH,
Dosman
JA.
1992.
Association
of
asthma
with
use
of
pesticides.
Results
of
a
cross­
sectional
survey
of
farmers.
Am
Rev
Respir
Dis
146(
4):
884­
887.

20Sharma
VK,
Kaur
S.
1990.
Contact
sensitization
by
pesticides
in
farmers.
Contact
Dermatitis
23:
77­
80.
There
were
also
two
studies
assessing
carbaryl's
potential
to
induce
an
allergic
reaction.
Senthilselvan
et
al.
(
1992)
19
reported
on
the
association
between
self­
reported
asthma
and
pesticide
use
in
1,939
farmers.
The
prevalence
of
asthma
was
significantly
associated
with
the
use
of
carbamate
insecticides
regardless
of
age,
smoking
pack­
years,
and
nasal
allergic
reactions.
The
authors
concluded
that
the
possibility
of
exposure
to
agriculture
chemicals
could
be
related
to
lung
dysfunction
in
exposed
farmers.

Sharma
and
Kaur
(
1990)
20
reported
on
30
farmers
that
had
contact
dermatitis
after
using
pesticides
for
several
years.
The
farmers
included
25
males
and
5
females,
between
the
ages
of
28
and
70
years
old.
Patch
testing
was
conducted
on
the
upper
back
and
readings
were
taken
on
the
second,
third,
and
seventh
day.
Allergic
reactions
to
one
or
more
pesticides
were
seen
in
11
patients.
One
patient
was
sensitive
to
carbaryl
and
two
patients
to
3
each
(
2,4­
D,
thiram,
carbaryl;
pendimethalin,
methyl
parathion
and
carbofuran).
Carbamates,
including
carbaryl,
were
the
most
frequent
sensitizers.
Allergic
reactions
did
not
occur
in
the
twenty
controls
included
in
the
study.

Unpublished
Epidemiology
Study
Rhone­
Poulenc
submitted
an
epidemiologic
study
of
plant
workers
exposed
to
carbaryl
titled
"
Standardized
Mortality
Ratio
Analysis
of
Employees
Exposed
to
Carbaryl
at
the
Rhone­
Poulenc
Institute,
West
Virginia
Plant",
which
was
reviewed
by
Dr.
Jerome
Blondell
(
DP
Barcode
D194815).
The
results
were
part
of
a
ten
year
vital
status
update
undertaken
by
the
National
Institute
of
Occupational
Safety
and
Health.
The
study
included
all
individuals
who
were
first
hired
between
1960
(
when
the
production
of
carbaryl
started)
and
through
1978.
The
vital
status
of
all
workers
was
determined
through
1988
using
the
National
Death
Index.

A
total
of
522
employees
were
identified
as
belonging
to
either
the
production,
packing/
distribution,
or
maintenance
facilities.
Follow­
up
through
1988
showed
25
deaths,
including
nine
due
to
cancer.
Significantly
less
deaths
(
50%)
were
seen
compared
to
the
number
expected.
No
category
of
death
resulted
in
a
statistically
significant
excess.
Those
categories
that
exhibited
an
excess
(
greater
than
the
number
of
expected
cases)
were
usually
based
on
a
single
reported
death
with
very
wide
confidence
intervals.
For
brain
cancer,
there
were
two
deaths
(
0.5
expected),
but
they
had
different
histologic
origin
which
reduces
the
likelihood
that
they
were
due
to
the
same
exposure.
HED
concluded
that
the
epidemiologic
study
does
not
add
significant
new
information
concerning
adverse
health
effects
of
carbaryl.
The
sample
of
workers
was
too
small
and
the
period
of
follow
up
to
too
short
to
permit
definitive
conclusions.
Domestic
Animal
Incident
Review
The
domestic
animal
incident
review
was
prepared
by
Dr.
Virginia
Dobozy
(
D266621
dated
June
12,
2000).
There
are
approximately
69
active
products
containing
carbaryl
with
use
sites
for
dogs
and
cats
in
OPP's
Reference
File
System
(
REFS).
The
majority
of
the
products
are
5­
10%
lawn
and
garden
dusts,
which
may
be
registered
for
use
on
animal
bedding
and
thus
are
included
in
the
REFS
search.
Most
of
the
powders
for
intentional
application
to
dogs
and
cats
for
flea
and
tick
control
also
contain
5­
10%
carbaryl,
some
in
combination
with
pyrethrins
and
synergists.
However,
two
products
contain
12.5%
carbaryl
in
combination
with
pyrethrins.
Three
products
contain
carbaryl
(
10­
12.5%)
in
combination
with
0.25%
methoxylchlor.
There
is
one
shampoo
which
contains
0.5%
carbaryl,
two
flea
collars
with
either
9.5%
(
cats)
or
17%
(
dogs)
carbaryl
and
a
dip
for
dogs
with
60%
carbaryl.
In
general,
the
use
of
powders,
dips
and
sprays
for
flea
and
tick
control
in
dogs
and
cats
has
been
replaced
within
the
last
five
years
with
oral
(
FDA
regulated)
or
spot­
on
formulations.
As
there
are
no
spot­
on
carbaryl
preparations,
it
can
be
assumed
that
the
use
of
this
chemical
for
flea
and
tick
control
has
declined.

There
are
213
reports
in
IDS
for
carbaryl
for
domestic
animals
from
1991
to
May,
2000.
Only
those
incidents
from
1998
(
most
recent
year
with
complete
data)
were
reviewed
in
order
to
provide
an
evaluation
of
current
adverse
reports
in
domestic
animals.
In
1998,
there
were
35
incidents
in
IDS
involving
23
dogs,
9
cats
and
1
pig.
One
incident
involved
two
dogs
and
in
three
incidents,
the
species
was
not
identified.
Only
two
incidents
involved
products
registered
for
use
on
dogs
and
cats.
In
one,
an
8
week­
old
kitten
treated
with
Zodiac
Flea
and
Tick
Powder
for
Dogs
developed
vomiting
and
anorexia
and
died
the
next
day.
In
the
other,
a
dog
was
reported
to
have
had
a
reaction
to
a
shampoo
with
carbaryl;
no
other
data
were
provided.
The
majority
of
the
remaining
incidents
involved
products
containing
a
5%
carbaryl
dust
or
a
molluscicide
which
contains
2%
metaldehyde
and
5%
carbaryl.
A
wide
variety
of
clinical
signs
were
reported.
Most
of
the
incidents
were
evaluated
and
classified
as
to
causality
(
doubtful,
low,
moderate
or
high
suspicion)
by
the
ASPCA/
National
Animal
Poison
Control
Center.
All
were
classified
as
doubtful
or
low
suspicion.
A
summary
review
of
incidents
for
a
5%
carbaryl
powder
from
one
registrant,
along
with
the
one
report
from
1998,
provided
some
evidence
that
young
kittens
(<
12
weeks)
may
be
susceptible
to
adverse
reactions
to
carbaryl.
It
is
recommended
that
all
labels
for
carbaryl
products
used
on
cats
contain
the
age
restriction
stated
in
PR
Notice
96­
6
(
should
not
be
used
in
kittens
less
than
12
weeks
of
age).