Document ID: EPA-HQ-OPP-2005-0163-0049
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-05-17T04:00Z

5/
17/
06
Request
for
Additional
Information
and
Suggestions
for
the
Reregistration
of
Aldicarb
Public
Comment
Period:

Dear
Reader:

The
purpose
of
this
document
is
to
summarize
the
current
human
health
risk
picture
for
aldicarb
and
solicit
mitigation
options.
The
preliminary
human
health
risk
assessments
will
be
released
for
60­
day
public
comment
period
May
17,
2006,
and
will
end
July
17,
2006.

Human
Studies
Review
Board
A
human
toxicity
intentional
dosing
study
was
used
in
the
aldicarb
risk
assessment.
EPA's
use
of
a
human
toxicity
study
in
the
aldicarb
risk
assessment
is
in
accordance
with
the
Agency's
Final
Rule
promulgated
on
January
26,
2006.
For
additional
information
relating
to
the
Human
Studies
Review
Board
determination
for
the
adicarb­
specific
study
used
in
the
risk
assessment,
refer
to
EPA's
website
at
http://
www.
epa.
gov/
osa/
hsrb/.

Dietary
Risks
Under
the
Food
Quality
Protection
Act
(
FQPA),
all
food
and
drinking
water
risks
for
a
given
pesticide
must
fit
within
the
pesticide's
"
risk
cup".
The
risk
cup
can
be
simply
defined
as
the
"
acceptable
level
of
exposure"
to
an
individual
from
a
pesticide,
on
an
acute
or
chronic
basis.
When
dietary
risks
are
of
concern,
EPA
is
required
to
mitigate
the
risks
down
to
acceptable
levels.

The
current
dietary
(
food
only)
risk
assessment
utilizes
PDP
and
the
Carbamate
Task
Force
(
CTF)
market­
basket
data
for
potatoes
and
citrus,
respectively.
Field
trial
data
were
used
for
all
other
commodities
(
except
sorghum,
sugar
beet
and
sugar
cane);
however,
residues
were
either
very
low
or
non­
detectable.
Percent
crop
treated
information
and
processing/
cooking
data
were
also
utilized
where
appropriate.
It's
important
to
note
that
since
aldicarb
is
systemic,
typical
food
preparation
practices
such
as
washing
and
peeling
are
not
expected
to
significantly
reduce
residues.

Sugar
beet
and
sugarcane
were
excluded
from
the
assessment
since
aldicarb
residues
are
not
expected
in
the
processed
commodities
as
consumed.
A
low
tolerance
level
was
used
for
sorghum
as
well
as
percent
crop
treated
but
resulting
estimates
did
not
contribute
to
risk.

Estimated
acute
dietary
exposure
and
risk
from
food
alone
exceed
EPA's
level
of
concern
(
i.
e.,
>
100
%
of
the
aPAD)
for
children
1­
2
years
and
children
3­
5
years
old
when
compared
to
the
rat
red
blood
cell
(
RBC)
cholinesterase
inhibition
(
ChEI)
endpoint.
The
estimated
dietary
risks
for
these
two
population
subgroups
at
the
99.9th
percentile
of
exposure
were
159%
and
129%,
of
the
acute
population
adjusted
dose
(
aPAD),
respectively.
For
the
general
U.
S.
population,
the
dietary
risk
was
72%
of
the
aPAD.
Estimated
risks
were
below
EPA's
level
of
concern
(
i.
e.,
<
100
%
of
the
aPAD)
at
the
99.8th
percentile
for
both
children
1­
2
years
old
and
children
3­
5
years
old.
Because
dietary
exposure
estimates
were
above
EPA's
level
of
concern
at
the
99.9th
percentile
of
exposure,
an
analysis
was
conducted
to
determine
which
food
or
food
forms
made
the
greatest
contribution
to
dietary
risk.
For
all
population
subgroups,
aldicarb
residues
in
potatoes
were
the
most
significant
source
of
dietary
exposure.
When
potatoes
are
removed
from
the
dietary
exposure
assessment,
all
remaining
risk
estimates
are
below
EPA's
level
of
concern.
Drinking
Water
Risks
Since
acute
dietary
risks
from
food
alone
were
above
EPA's
level
of
concern
(
i.
e.,
>
100
%
of
the
aPAD),
a
drinking
water
only
assessment
was
conducted.
If
all
of
the
allowable
exposure
occurred
through
drinking
water,
EPA
would
not
have
concerns
for
acute
exposure
to
aldicarb
residues
in
surface
water.
Acute
surface
water
risk
estimates
for
infants,
the
most
highly
exposed
population
subgroup,
range
from
1%
of
the
aPAD
[
potatoes]
to
15%
of
the
aPAD
[
cotton]
at
the
95th
percentile
of
exposure.
Acute
surface
water
risk
estimates
for
the
general
U.
S.
population
and
all
other
population
subgroups
ranged
from
<
1%
of
the
aPAD
to
7%
of
the
aPAD.

Seven
regional
ground
water
monitoring
residue
levels
were
used
to
derive
an
acute
dietary
exposure
estimate
for
ground
water
alone.
The
data
indicate
that
acute
exposure
from
ground
water
sources
of
drinking
water
is
of
concern,
with
acute
risk
estimates
ranging
from
20%
of
the
aPAD
to
945%
of
the
aPAD.

Drinking
water
risks
based
on
ground
water
monitoring
data
overestimate
the
risks
for
all
but
those
who
obtain
their
drinking
water
from
wells
in
vulnerable
aldicarb
use
areas.
However,
since
acute
food
only
exposures
exceed
the
aPAD,
EPA
is
concerned
about
any
additional
exposure
(
to
all
subpopulations)
through
drinking
water,
regardless
of
the
source.

Occupational
Risks
The
occupational
risk
assessment
for
aldicarb
is
based
on
potential
exposure
to
agricultural
workers
during
loading
and
application
of
granular
products.
Aldicarb
is
applied
early
in
the
growing
season,
and
labels
require
immediate
soil
incorporation
of
granules;
postapplication
exposures
are
not
expected
for
workers,
so
a
quantitative
postapplication
risk
assessment
has
not
been
conducted.

Unlike
some
pesticides,
aldicarb
has
worker
exposure
data
that
has
been
conducted
with
aldicarb
and
mirrors
how
aldicarb
is
packaged,
handled,
and
used
in
agriculture.
This
study
was
used
to
conduct
the
occupational
risk
assessment
for
aldicarb.
Pesticide
Handler's
Exposure
Data
(
PHED)
were
also
used
in
conducting
the
risk
assessment
since
the
aldicarb­
specific
study
did
not
quantify
potential
risks
from
closed
loading
and
closed
cab
scenarios.
Therefore,
for
the
portion
of
the
occupational
assessment
which
used
the
aldicarb­
specific
worker
exposure
data,
risks
were
not
of
concern
for
most
loader
and
applicator
exposure
scenarios.
However,
risks
for
loaders
were
identified
for
two
scenarios
(
MOEs
for
loaders
range
from
14
to
130
and
MOEs
for
applicators
range
from
34
to
324).

When
using
the
PHED
data
for
the
closed
loading
and
closed
cab
scenarios,
similar
results
to
those
found
with
the
aldicarb­
specific
study
were
noted
for
loaders.
However,
when
using
PHED
data
for
applicators,
all
scenarios
exceeded
EPA's
level
of
concern
(
MOEs
for
loaders
range
from14
to
139;
MOEs
for
applicators
range
from
1
to
13).

Environmental
Risks
The
environmental
risk
assessment
is
based
on
maximum
rates
and
average
usage
rates
of
aldicarb.
The
environmental
risk
assessment
includes
risks
to
terrestrial
and
aquatic
organisms.
Using
multiple
lines
of
evidence
(
such
as
use
scenarios,
average
or
"
typical"
application
rates,
registrant
submitted
toxicity
studies,
open
literature
data,
and
field
monitoring
data),
aldicarb
poses
acute
risks
(
mortality)
to
birds,
mammals,
and
aquatic
organisms.
In
addition,
there
is
the
potential
for
chronic
reproductive
effects
in
fish
and
invertebrates.

Terrestrial
Organisms
For
terrestrial
organisms,
acute
levels
of
concern
are
consistently
exceeded
by
a
factor
of
greater
than
100x
and
are
frequently
exceeded
by
more
than
1000x.
Granules
left
exposed
on
the
surface
appear
to
be
the
main
source
of
exposure,
but
other
sources
such
as
residues
taken
up
by
plants
and
contaminated
earthworms
may
also
serve
as
a
means
of
exposure.

Aquatic
Organisms
For
aquatic
organisms,
there
are
acute
risks
for
freshwater
fish
and
invertebrates
and
estuarine/
marine
fish
and
invertebrates
for
all
of
the
registered
uses
with
the
exception
of
potatoes
for
freshwater
fish
and
invertebrates
and
estuarine/
marine
fish.

The
chronic
level
of
concern
is
exceeded
for
freshwater
invertebrates
(
reproductive
effects)
and
estuarine/
marine
invertebrates
(
average
number
of
offspring
endpoint)
for
all
of
the
registered
uses.
Chronic
concerns
(
larval
and
juvenile
survival)
also
exist
for
freshwater
fish
for
soybean,
cotton,
and
pecan
use
patterns.

Aldicarb
residues
are
most
likely
to
exceed
levels
of
concern
for
fish
and
aquatic
invertebrates
in
low­
order
streams
because
these
streams
are
dominated
by
base
flow
conditions
(
where
100%
of
stream
flow
consists
of
discharged
groundwater),
and
most
of
the
toxic
residues
are
believed
to
form
within
the
subsurface
(
especially
within
the
saturated
zone).
In
addition,
much
larger
contributing
land
areas
sustain
higher­
order
streams,
so
there
is
a
greater
dilution
effect.
In
addition
to
risk
based
exposure
estimates
from
modeling,
there
were
also
exceedances
of
the
Agency
levels
of
concern
based
on
monitoring
data.

Solicitation
for
Benefits
Information
and
Risk
Management
Suggestions
At
this
time
the
dietary
and
occupational
risks
from
aldicarb
are
of
concern
for
some
registered
uses.
In
addition,
the
Agency
has
performed
preliminary
alternatives
analyses,
to
identify
available
alternatives
for
the
uses
of
aldicarb
that
pose
the
highest
risks
(
see
"
Preliminary
Impact
Analysis
for
Aldicarb
on
Potatoes",
"
Preliminary
Impact
Analysis
for
Aldicarb
on
Major
Citrus
Crops",
and
"
Impact
Analysis
for
Aldicarb
on
Cotton").
It
is
important
to
note
that
FQPA
does
not
allow
for
the
consideration
of
benefits
analyses
for
risks
associated
with
dietary
exposure
assessments;
therefore,
benefits
analyses
play
an
important
role
in
only
non­
dietary
considerations,
such
as
ecological
and
worker
risks.
Alternative
analyses
for
potatoes,
citrus
and
cotton
are
available
in
the
docket,
and
show
that
although
there
are
alternatives
available
for
aldicarb,
they
tend
to
be
more
costly
and
less
effective.
At
this
time,
the
Agency
has
not
been
able
to
identify
many
viable
options
for
effectively
mitigating
the
dietary
risks
from
aldicarb.
Thus,
EPA
is
soliciting
input
from
interested
stakeholders
on
benefits
information
(
i.
e.
critical
uses
of
aldicarb,
and
impacts
to
growers
from
the
loss
of
aldicarb),
as
well
as
risk
management
suggestions.
If
you
would
like
to
provide
this
type
of
input,
please
submit
your
comments
directly
to
the
docket.

Here
is
a
list
of
sample
questions
that
may
help
you
in
preparing
comments:

(
1)
In
what
regions
(
state/
county,
etc.)
of
the
U.
S.
is
aldicarb
use
occurring?
(
2)
What
are
the
pests
that
you
feel
aldicarb
is
critical
for
controlling?
(
3)
What
are
the
details
of
typical
usage
patterns
(
e.
g.,
number
of
applications
per
season,
use
rate
per
application,
acres
treated,
and
time
of
application
in
the
season?)
(
4)
What
worker
activities
typically
occur
when
aldicarb
is
applied?
(
5)
What
alternatives,
if
any,
do
you
believe
are
available
to
replace
aldicarb?

Please
provide
as
much
detail
and
documentation
in
your
comments
as
possible
so
that
the
Agency
is
fully
informed
in
its
decision­
making.