Document ID: EPA-HQ-OPP-2006-0293-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-04-26T04:00Z

Reregistration
Eligibility
Decision
Exposure
and
Risk
Assessment
on
Lower
Risk
Pesticide
Chemicals
Sabadilla
Alkaloids
Special
Review
and
Reregistration
Division
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
1801
South
Bell
Street
Arlington,
VA
22202
Table
of
Contents
Background
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1
I.
Executive
Summary
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1
II.
Use
Information
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3
III.
Physical/
Chemical
Properties
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3
IV.
Hazard
Assessment
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4
Toxicity
Data
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4
Special
Considerations
for
Infants
and
Children
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6
Toxicity
Endpoint
Selection
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VI.
Dietary
(
Food)
Exposure
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11
VII.
Drinking
Water
Exposure
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12
VIII.
Aggregate
Assessment
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13
IX.
Risk
Characterization
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14
X.
Environmental
Fate/
Ecotoxicity/
Drinking
Water
Considerations
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14
XI.
Cumulative
Exposure
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16
XII.
Tolerance
Reassessment
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16
XIII.
References
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16
Appendix
1.
BEAD
Screening
Level
Estimate
of
Agricultural
Uses
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17
Appendix
2.
Sabadilla
Alkaloids:
Acute
and
Chronic
Dietary
Exposure
Assessments
.
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20
1
Background:

The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient,
as
well
as
a
review
of
all
submitted
data
by
the
U.
S.
Environmental
Protection
Agency
(
referred
to
as
EPA
or
the
Agency).
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
hazards
arising
from
the
currently
registered
uses
of
the
pesticide;
to
determine
the
need
for
additional
data
on
health
and
environmental
effects;
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.

On
August
3,
1996,
the
Food
Quality
Protection
Act
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
to
require
tolerance
reassessment
during
reregistration.
It
also
requires
that
by
2006,
EPA
must
review
all
tolerances
in
effect
on
the
day
before
the
date
of
the
enactment.
FQPA
also
amends
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
to
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
an
assessment
of
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity.

This
document
represents
the
Lower
Risk
Pesticide
Chemical
Focus
Group's
(
LRPCFG)
Reregistration
Eligibility
Decision
(
RED)
and
the
reassessment
of
the
exemption
from
the
requirement
of
a
tolerance
for
residues
on
sabadilla
alkaloids.
This
assessment
summarizes
available
information
on
the
use,
physical/
chemical
properties,
toxicological
effects,
exposure
profile,
occupational
exposure
and
reentry,
dietary
assessment,
environmental
fate
and
ecotoxicity,
and
ecological
risk
assessments
for
sabadilla
alkaloids.
In
compiling
this
RED
and
performing
this
tolerance
reassessment,
EPA
has
utilized
reviews
previously
performed
by
U.
S.
EPA
and
the
California
Department
of
Pesticide
Regulation
(
CDPR).
EPA
established
an
exemption
from
the
requirement
for
a
tolerance
for
residues
of
sabadilla
alkaloids
when
used
as
an
active
ingredient
in
products
applied
to
growing
crops,
in
accordance
with
good
agricultural
practice.
The
Agency
has
considered
any
new
data
generated
after
the
tolerance
exemption
was
issued,
new
Agency
guidance
or
other
federal
regulations,
as
well
as
previously
available
information
in
this
assessment.

I.
Executive
Summary:

Sabadilla
alkaloids
are
insecticides
used
for
the
control
of
thrips
on
citrus,
avocados,
and
mangos.
The
available
toxicity
information
was
collected
on
sabadilla
alkaloids,
and
an
endpoint
was
selected
for
assessing
short­
term
exposures
for
occupational
handlers
and
for
post­
application
exposures,
as
well
as
dietary
exposures.
An
oral,
toxicological,
no
observed
adverse
effects
level
(
NOAEL)
endpoint
of
11
mg/
kg/
day
for
the
alkaloids
(
derived
from
a
NOEL
of
250
mg/
kg/
day
on
seed)
was
selected
to
assess
the
short­
term
dermal
and
inhalation
handler
exposures,
post­
application
dermal
exposures,
and
dietary
exposures.
The
dermal
and
inhalation
doses
were
conservatively
estimated
from
the
equivalent
oral
dose
using
a
100%
absorption
factor.
An
uncertainty
factor
of
100
(
10
for
interspecies
extrapolation
and
10
for
intraspecies
variation)
was
used
for
this
assessment,
and
therefore,
the
Margin
of
Exposure
(
MOE)
of
concern
is
100
for
the
occupational
handler
and
post­
application
exposures.

Sabadilla
alkaloids
are
formulated
as
a
wettable
powder
for
use
as
an
insecticide
on
citrus,
avocados,
and
mangos,
and
mixed
with
water
and
applied
with
either
aerial
or
ground
equipment.
The
exposure
scenarios
chosen
for
this
risk
assessment
were
based
on
the
anticipated
use
patterns
from
the
current
label
for
the
sabadilla
alkaloids
end­
use
product.
In
addition,
the
application
rates
were
determined
based
on
2
information
provided
on
the
currently
registered
product
label.
For
the
agricultural
crop
scenarios,
the
only
short­
term
dermal
MOE
less
than
100
was
the
baseline
attire
scenario
for
the
Mixing/
Loading
Wettable
Powders
for
Aerial
Applications.
However,
with
the
addition
of
personal
protective
equipment
(
PPE),
specifically,
chemical­
resistant
gloves,
this
scenario
also
reached
an
MOE
of
greater
than
100.
All
of
the
inhalation
MOEs
were
greater
than
100.

In
order
to
assess
occupational
post­
application
exposure,
transfer
coefficients
were
used
to
numerically
represent
the
post­
application
exposures
an
individual
would
receive.
The
approach
used
to
reduce
postapplication
risks
is
referred
to
as
the
Restricted
Entry
Interval
(
REI).
The
REI
is
a
time
period
following
a
pesticide
application
during
which
entry
into
the
treated
area
is
restricted.
The
REIs
calculated
for
the
varying
levels
of
exposure
to
sabadilla
alkaloids
are
all
less
than
24
hours.
The
product
label
states
that
worker
entry
into
treated
areas
is
restricted
for
24
hours
after
application
and
that
early
entry
to
treated
areas
requires
the
use
of
PPE.
Therefore,
post­
application
exposure
to
workers
is
minimal.

Sabadilla
alkaloid
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model.
The
assessments
show
that
the
sabadilla
alkaloids
are
38%
of
the
aPAD
and
8%
of
the
cPADfor
the
most
sensitive
age
group
(
children
1­
2
years
old),
and
less
than
13%
of
the
aPAD
and
3%
of
the
cPAD
for
the
general
U.
S.
population.
In
addition,
the
estimated
drinking
water
concentrations
(
EDWCs)
were
calculated
by
utilizing
models.
The
estimated
drinking
water
concentrations
are
very
low
for
the
various
sabadilla
alkaloids,
ranging
between
1.62
and
1.80
ppb
for
the
annual
peak
concentrations,
and
0.05
and
0.10
ppb
for
the
annual
mean
concentrations
for
surface
waters,
and
0.00072
ppb
(
0.72
parts
per
trillion)
for
groundwater.

Very
little
measured
data
are
available
on
the
physical
and
chemical
properties
or
the
environmental
fate
of
sabadilla
alkaloids.
The
major
route
of
dissipation
and
degradation
appears
to
be
photolysis,
because
biodegradation
and
hydrolysis
occur
at
considerably
slower
rates.
Volatilization
from
soil
and
water
is
probably
not
important,
due
to
the
expected
low
vapor
pressures.
While
no
measured
data
are
available
on
soil
mobility,
the
physical
and
chemical
properties
of
sabadilla
alkaloids
indicate
likely
low
mobility
in
soil.

Available
and
estimated
data
on
toxicity
and
exposure
indicate
that
sabadilla
alkaloids
present
minimal
risks
to
small
mammals
on
an
acute
basis.
Risk
assessments
suggest
risk
concerns
for
endangered
species
(
mammals)
at
the
maximum
application
rates,
but
at
the
typical
application
rates,
with
shorter
estimated
half­
lives,
and
longer
intervals
between
applications,
the
endangered
species
risks
were
only
slightly
elevated,
and
only
for
small
mammals
(
15
grams)
feeding
on
short
grass.
Risks
to
terrestrial
plants
cannot
be
quantified
due
to
a
lack
of
phytotoxicity
data.
Similarly,
no
data
were
available
to
quantify
the
acute
or
chronic
risks
to
birds,
but
the
available
acute
ecotoxicity
data
for
fish
do
not
suggest
a
substantial
potential
for
adverse
effects,
and
QSAR
estimates
on
the
alkaloids
indicate
no
chronic
toxicity
concerns
for
fish
and
green
algae,
and
no
acute
concerns
for
daphnia.
Furthermore,
there
is
only
a
small
volume
of
end­
use
product
used
on
an
annual
basis,
on
a
limited
number
of
minor
use
crops,
in
a
limited
geographical
area,
further
suggesting
that
the
ecological
risks
would
not
be
expected
to
be
very
wide­
spread.
Note
also,
with
respect
to
endangered
species,
this
is
a
screening
level
and/
or
qualitative
assessment,
and
does
not
constitute
any
findings
under
the
Endangered
Species
Act.

II.
Use
Information:
3
Sabadilla
alkaloids
are
insecticides
used
for
the
control
of
citrus
thrips
and
other
species
of
thrips.
The
alkaloids
are
obtained
as
an
extract
from
the
ground
seeds
from
the
sabadilla
plant,
with
the
primary
insecticidal
component
being
veratrine
(
CAS
No.
8051­
02­
3),
consisting
of
a
complex
mixture,
with
the
two
primary
alkaloids
being
cevadine
(
crystalline
veratrine)
and
veratridine
(
amorphous
veratrine),
according
to
the
Merck
Index.

At
present,
there
is
only
one
registered
product
containing
sabadilla
as
an
active
ingredient
(
EPA
Registration
Number
39834­
1).
This
product
is
used
for
agricultural
purposes
on
citrus,
avocados,
and
mangos.
There
are
no
residential
uses.
The
formulation
is
a
wettable
powder,
with
the
active
ingredient
listed
on
the
label
as
"
0.2%
sabadilla
alkaloids."
The
label
lists
both
aerial
and
ground
application
methods,
with
the
following
rates:
10
to
15
lbs
(
of
end­
use
product)
per
acre
in
10
to
40
gallons
of
water
for
aerial
applications;
and
for
ground
applications,
10
to
15
lbs
per
acre
in
20
to
100
gallons
of
water,
unless
200
gallons
of
spray
are
applied
per
acre,
then
the
maximum
rate
is
20
lbs
per
acre.
The
label
also
indicates
the
following,
for
each
of
the
three
crops:
"
Reapply
as
needed,
usually
at
a
10­
14
day
interval.
Do
not
apply
at
time
of
harvest."
The
label
does
not
indicate
the
maximum
number
of
times
per
year
the
product
may
be
applied,
nor
is
information
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
their
various
Usage
and
Label
Use
Data
Reports
for
the
maximum
number
of
applications
per
growing
season
or
per
year,
but
BEAD
does
indicate
that
timing
of
the
applications
may
be
made
as
follows:
pre­
bloom,
bloom,
and
foliar
applications.
The
EFED
Science
Assessment
utilized
3
applications
per
year.

BEAD
does
not
provide
a
recent
Quantitative
Usage
Analysis,
but
does
provide
a
recent
Screening
Level
Estimate
of
Agricultural
Uses,
which
lists
less
than
500
pounds
of
active
ingredient
per
year
applied
to
each
crop
(
See
Appendix
A).
The
EFED
Science
Assessment
references
the
Pesticide
Action
Network
(
PAN,
2004)
on­
line
data,
which
estimates
that
264.3
Gross
Pounds
per
year
(
based
on
the
amount
of
active
ingredient)
are
applied
in
California.
Based
on
its
usage
pattern,
most
of
the
end­
use
product
is
probably
applied
in
the
State
of
California.

The
exemption
from
the
requirement
of
a
tolerance
being
reassessed
in
this
document,
the
respective
citation
in
the
Code
of
Federal
Regulations
(
CFR),
and
the
use
pattern
as
an
active
ingredient
are
listed
in
Table
1.

Table
1.
Exemption
from
the
Requirement
of
a
Tolerance
Reassessed
in
this
Document
Tolerance
Exemption
Expression
CAS
No.
40
CFR
PC
Code
Use
Pattern
Sabadilla
8051­
02­
3
180.905
(
a)(
8)
a
002201
Insecticide
a
Residues
listed
in
section
(
a)
of
40
CFR
180.905
are
exempt
from
a
tolerance
when
applied
to
growing
crops;
section
(
b)
indicates
that
the
pesticides
in
section
(
a)
are
not
exempted
from
the
requirement
of
a
tolerance
when
applied
to
a
crop
at
the
time
of
or
after
harvest.
The
label
for
the
only
sabadilla
alkaloids
end­
use
product
indicates
"
Do
not
apply
at
time
of
harvest."
There
are
also
no
post­
harvest
uses.

III.
Physical/
Chemical
Properties:

The
physical
and
chemical
properties
of
the
two
primary
sabadilla
alkaloids,
cevadine
and
veratridine,
as
well
as
some
of
the
secondary
alkaloids,
are
provided
in
Table
2.
The
Environmental
Fate
and
Effects
4
Division
(
EFED)
Science
Assessment
reported
that
the
measured
water
solubility
of
the
veratrine
mixture
was
555
mg/
L.
That
assessment
also
reported
that
"
Very
little
experimental
data
are
available
on
the
chemical
and
physical
properties
of
the
individual
alkaloids.
Due
to
the
lack
of
experimental
data,
many
estimates
of
properties
used
for
quantifying
exposures
must
be
based
on
quantitative
structure
activity
relationships
(
QSARs)."
The
EPIWIN
model
was
utilized.
In
addition,
the
EFED
Science
Assessment
reported
that
"
the
vapor
pressure
and
Henry's
Law
constants
for
the
sabadilla
alkaloids
are
negligible."
Although
the
numerical
QSAR
estimated
vapor
pressure
values
not
actually
reported,
the
information
presented
indicates
that
the
potential
volatilization
from
water
or
from
moist
soil
is
very
limited,
and
similarly
that
the
potential
for
inhalation
exposure
is
minimal.

Table
2.
Physical/
Chemical
Properties
for
the
Primary
Sabadilla
Alkaloids,
Cevadine
and
Veratridine,
as
well
as
for
some
of
the
secondary
alkaloids
Chemical
CAS
No.
Molecular
formula
Molecular
weight
Melting
point
Water
Solubility
(
mg/
L)
Dissociation
Constant
(
pKa)
Octanol­
Water
Partition
Coefficient
(
Log
Kow)
Soil
Sorption
Coefficient
(
mL/
g)
(
Koc)

Cevadine
62­
59­
9
C32H49NO9
591.7
205oC
d
570
b
9.2
c
0.89
a
9.7
x
104
a
Veratridine
71­
62­
5
C23H51NO11
673.8
180oC
d
140
a
9.54
d
0.68
a
2.0
x
105
a
Sabadine
124­
80­
1
C29H47NO8
573.7
285oC
a
2,232
a
9.2
c
0.32
a
1.8
x
105
a
Sabadinine
124­
98­
1
C27H43NO8
509.6
281oC
a
1
x
106
a
9.2
c
­
1.20
a
6.1
x
104
a
Sabadilline
1415­
76­
5
C34H53NO8
NA
NA
NA
NA
NA
NA
References:
a)
EPIWIN
(
2004),
b)
Gunther
et
al.
(
1968),
c)
SPARC
(
2004),
d)
Tomlin
(
2003),
and
e)
Toxnet
(
2004).

NA:
Not
Available.

IV.
Hazard
Assessment:

Toxicity
Data:

Key
toxicological
data
for
sabadilla
alkaloids
are
provided
in
Table
3.
These
data
were
obtained
from
data
reviews
by
CDPR
(
2001),
and
two
EPA
Data
Evaluation
Records
(
EPA,
1996,
and
2004).

Table
3.
Summary
of
Toxicity
Data
for
Sabadilla
Alkaloids
Acute
Toxicity
Test
Species
Route
of
Administration
Results
Toxicity
Category
Reference
Oral
LD50
(
mg/
kg­
body
weight)
Rat
Oral
>
5000
(
no
deaths)
IV
EPA
(
1996)
Dermal
(
mg/
kg­
body
weight)
Rabbit
Dermal
>
2000
(
no
deaths)
III
Inhalation
(
mg/
L)
Rat
Inhalation
>
2.10
(
no
deaths)
IV
EPA
(
2004)
Test
Species
Route
of
Administration
Results
Toxicity
Category
Reference
5
Eye
Irritation
Rabbit
Eye
instillation
some
effects
on
cornea
and
iris,
plus
redness
of
conjunctiva
at
1
hour,
but
non­
irritating
(
clear)
at
24
hours
and
thereafter
IV
EPA
(
1996)
Dermal
Irritation
Rabbit
Applied
topically
No
irritation
observed
IV
Dermal
Sensitization
Guinea
pig
Modified
Buehler
assay
Non­
Sensitizing
(
no
dermal
response
in
screening,
induction,
or
challenge
phases)

Subchronic
Oral
Toxicity
Oral
(
mg/
kg/
day)
Rat
Diet:
ground
sabadilla
seeds
admixed
with
feed:
90
days
NOEL:
250
mg/
kg/
day
LOEL:
500
mg/
kg/
day
Reduced
food
consumption
in
high­
dose,
and
reduced
body
weights
in
mid­
and
high­
dose
males
and
females.
Dose
range
(
nominal):
0,
250,
500,
and
1000
mg/
kg/
day
[
Sabadilla
Seed
­
Technical
grade
(
Veratran
Technical,
purity:
4.83%
Total
Alkaloids)]
CDPR
(
2001)

Reproductive
and
Developmental
Toxicity
Oral
(
mg/
kg/
day)
Rat
Gavage:
gestation
days
6­
17
Maternal
NOEL:
50
mg/
kg/
day
Developmental
NOEL:
250
mg/
kg/
day
Maternal
LOEL:
250
mg/
kg/
day
(
clinical
signs)
Developmental
LOEL:
500
mg/
kg/
day
(
reduced
mean
fetal
weights,
as
well
as
misaligned
and
unossified
sternebrae)
No
adverse
development
effects.
Dose
range:
0,
50,
250,
and
500
mg/
kg/
day
[
Veratran
D,
Technical,
assumed
100%]
CDPR
(
2001)

The
CDPR
review
document
(
2001)
also
provided
information
on
gene
mutation,
chromosome
effects,
and
DNA
damage.
In
the
mutagenesis
study
performed
to
evaluate
the
mutagenic
potential
of
sabadilla
using
mouse
lymphoma
cells,
it
was
reported
that
ground
sabadilla
seed
did
not
increase
mutation
frequency
(
without
activation),
but
those
mouse
lymphoma
cells
plated
with
rat
liver
metabolic
activation
were
found
to
exhibit
mutant
frequencies
approximately
two­
fold
greater
than
the
solvent
control.
This
response
is
generally
regarded
as
equivocal,
as
the
study
authors
concluded
(
MRID
46283307),
and
is
usually
confirmed
by
repeating
the
assay
with
metabolic
activation.
The
study
investigators
also
noted
that
there
was
no
dose­
related
response
in
this
assay
and
significant
toxicity
(
growth
#
50%
of
the
solvent
control)
was
observed
at
the
4
highest
doses.
The
study
report
also
indicated
a
problem
with
test
substance
sterility,
which
was
solved
by
irradiating
the
test
material,
yet
no
information
on
the
effects
of
radiation
on
the
alkaloid
constituents
is
included.
In
addition,
DSMO
was
used
to
suspend
the
ground
seed
for
testing
which
raises
a
question
of
consistency
in
dosing
in
vitro.

The
CDPR
review
reported
additional
findings
from
the
mutagenesis
study,
specifically,
an
increase
in
small
colonies
compared
with
solvent
controls,
"
suggesting
chromosomal
aberrations
on
chromosome
11
as
well
as
more
localized
damage,"
and
concluded
there
was
a
"
possible
adverse
effect"
as
a
result
of
exposure
of
mouse
lymphoma
cells
to
the
ground
sabadilla
seeds.
It
should
be
noted,
however,
that
the
6
doses
tested
did
exhibit
some
cytotoxicity.
Furthermore,
a
micronucleus
cytogenetic
assay
(
MRID
46283309)
was
conducted
in
mice
and
reviewed
by
CDPR.
CDPR
determined
that
the
results
indicated
that
there
was
no
evidence
of
induction
of
micronuclei
in
the
polychromatic
erythrocytes
of
the
mice
exposed
to
ground
sabadilla
seeds,
mixed
into
water
and
injected
into
the
mice.
An
Ames
test
(
MRID
46283311)
was
also
submitted,
and
there
was
no
evidence
of
mutagenic
activity
at
dose
levels
up
to
5,000
:
g/
ml
with
or
without
metabolic
activation.

The
Agency
considers
the
negative
results
in
the
micronucleus
and
Ames
tests
as
further
evidence
that
the
equivocal
results
in
the
mouse
lymphoma
assay
are
not
a
concern.
Therefore,
the
available
mutagenicity
studies
did
not
indicate
that
sabadilla
alkaloids
had
a
potentially
adverse
effect
on
chromosome
structure.

Special
Considerations
for
Infants
and
Children:

The
developmental
toxicity
study
reviewed
in
the
CDPR
document
(
2001)
examined
maternal
and
development
effects
in
female
rats
exposed
to
sabadilla
alkaloids
during
gestation
days
6
through
17.
Development
effects,
including
an
increase
in
skeletal
variations
(
arches
incompletely
ossified,
sternebrae
unossified,
and
sternebrae
misaligned),
were
observed
at
500
mg/
kg/
day.
However,
the
CDPR
DER
concluded
that
these
effects
were
"
not
a
direct
effect
of
sabadilla,
but
associated
with
reduced
fetal
weight."
Moreover,
the
effects
in
the
maternal
group
were
observed
at
the
mid­
dose
feeding
level.
Therefore,
considering
that
at
this
time,
the
available
data
do
not
indicate
any
potential
sensitivity
to
infants
and
children
resulting
from
exposure
to
sabadilla
alkaloids,
the
additional
tenfold
FQPA
safety
factor
is
deemed
unnecessary,
and
has
been
removed.

Toxicity
Endpoint
Selection:

For
this
assessment
of
sabadilla
alkaloids,
short­
term
(
1
to
30
days)
occupational
handler
inhalation
and
dermal
exposure
were
examined,
as
well
as
post­
application
dermal
exposures,
and
acute
and
chronic
dietary
exposures.
Inhalation
exposures
are
thought
to
be
negligible
in
outdoor
post­
application
scenarios
due
to
the
infinite
dilution
expected
outdoors
and
the
very
low
vapor
pressure.
As
such,
inhalation
postapplication
exposures
are
not
considered
in
this
assessment.

Since
there
are
no
inhalation
or
dermal
toxicological
studies
available
in
the
existing
literature,
an
oral
NOAEL
was
used
to
assess
short­
term
dermal
and
inhalation
exposures.
The
dermal
and
inhalation
doses
were
conservatively
converted
to
an
equivalent
oral
dose
using
a
100%
absorption
factor.
The
same
NOAEL
was
utilized
for
post­
application
dermal
exposures
and
acute
and
chronic
dietary
exposures.
The
oral
toxicological
endpoint
used
for
sabadilla
alkaloids
was
a
NOAEL
of
11
mg/
kg/
day,
derived
from
a
NOEL
(
as
identified
in
the
CDPR
review)
of
250
mg/
kg/
day
from
the
90­
day
feeding
study
on
sabadilla
seed
containing
4.83%
total
alkaloids.
The
250
mg/
kg/
day
concentration
selected
as
the
NOEL
in
the
90­
day
study
was
identified
as
a
nominal
dose,
with
the
actual
dose
being
230
mg/
kg/
day.
Therefore,
the
NOAEL
of
11
mg/
kg/
day
on
the
alkaloids
was
calculated
as
4.83%
of
230
mg/
kg/
day.
This
NOEL
(
250
mg/
kg/
day)
for
the
seed
was
based
on
decreased
relative
liver
weights,
elevated
serum
chemistry
(
BUN),
as
well
as
reduced
food
consumption
and
body
weights
in
females
at
the
next
highest
dose
level
of
500
mg/
kg/
day.

The
developmental
toxicity
study,
also
performed
on
the
sabadilla
seed,
in
the
CALEPA
document
(
2001)
identified
a
maternal
NOEL
of
50
mg/
kg/
day
based
on
body
surface
staining,
red
area
around
eyes,
material
around
eyes,
and
increased
salivation
in
the
250
mg/
kg/
day
group.
These
effects,
however,
are
not
7
considered
"
adverse"
by
the
Agency
and
may
be
gavage
related,
therefore
250
mg/
kg/
day
is
considered
to
be
the
NOAEL
based
on
adverse
clinical
effects
(
e.
g.,
ataxia,
abnormal
gait,
decreased
activity,
and
labored
breathing)
observed
at
500
mg/
kg/
day.

V.
Exposure
Assessment:

Sabadilla
alkaloids
are
formulated
as
a
wettable
powder
for
use
as
an
insecticide
on
citrus,
avocados,
and
mangos.
The
end­
use
product
is
applied
with
either
aerial
or
ground
(
i.
e.,
airblast)
equipment.
Table
4
provides
the
acres
treated
per
day
and
the
maximum
application
rate
for
each
type
of
application
method.
The
daily
acres
treated
were
defined
for
each
handler
scenario
(
in
appropriate
units)
by
determining
the
amount
that
can
be
reasonably
treated
in
a
single
day
(
e.
g.,
acres,
square
feet,
cubic
feet,
or
gallons
per
day).
It
was
assumed
that
the
average
occupational
workday
is
8
hours.

Table
4:
Summary
of
Maximum
Application
Rates
for
Sabadilla
Alkaloids
Agricultural
Crop
Uses
Crop
Type/
Use
Site
Application
Equipment
Acres
Treated
Per
Day
Maximum
Application
Rate
Citrus,
avocados,
mango
aerial
350
0.03
lb
ai/
acrea
airblast
40
0.04
lb
ai/
acreb
a
From
product
label,
0.2%
sabadilla
alkaloids
as
active
ingredient;
apply
15
pounds
of
end­
use
product
per
acre
maximum;
assumed
percent
by
weight;
therefore,
apply
0.03
lb
ai/
acre.
b
From
label
regarding
Ground
Application:
"
Use
10
to
15
lbs.
per
acre
in
20
to
100
gallons
of
water.
If
200
gallons
of
spray
solution
are
applied
per
acre
increase
dose
to
20
lbs
per
acre."
Therefore,
maximum
application
rate
for
ground
application
is
0.04
lb
ai/
acre.

It
has
been
determined
that
there
is
a
potential
for
exposure
to
sabadilla
alkaloids
in
occupational
scenarios
from
handling
sabadilla
alkaloids
products
during
the
application
process
(
i.
e.,
mixer/
loaders,
applicators,
and
flaggers),
and
a
potential
for
post­
application
worker
exposure
from
entering
into
areas
previously
treated
with
sabadilla
alkaloids.
As
a
result,
risk
assessments
have
been
completed
for
occupational
handler
scenarios
as
well
as
occupational
post­
application
scenarios.

The
exposure
scenarios
chosen
for
this
risk
assessment
were
based
on
the
anticipated
use
patterns
and
the
current
label
for
the
sabadilla
alkaloids
product
(
see
Table
5).
In
addition,
the
application
rate
was
estimated
based
on
information
provided
on
the
product
label.
The
average
body
weight
of
an
adult
(
70
kg)
was
assumed.
The
oral
NOAEL
of
11
mg/
kg/
day
was
used
for
the
short­
term
exposure
estimates.
An
uncertainty
factor
of
100
(
10
for
interspecies
extrapolation
and
10
for
intraspecies
variation)
was
used
for
this
assessment
and,
therefore,
the
MOE
of
concern
is
100
for
the
occupational
exposure
risk
assessment.

The
occupational
handler
exposure
assessments
were
completed
considering
different
levels
of
personal
protective
equipment
(
PPE).
A
tiered
approach
was
used,
with
the
lowest
tier
represented
by
the
baseline
attire
exposure
scenario
(
i.
e.,
long­
sleeve
shirt,
long
pants,
shoes,
and
socks),
followed
by
increasing
levels
of
personal
protective
equipment
or
PPE
(
e.
g.,
gloves,
double­
layer
body
protection,
and
respirators)
and
engineering
controls
(
e.
g.,
enclosed
cabs
and
closed
mixing/
loading
systems).
Because
there
were
no
chemical­
specific
worker
exposure
data
for
sabadilla
alkaloids,
occupational
handler
exposure
estimates
were
based
on
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED).

Based
on
the
expected
usage
pattern,
only
short­
term
exposure
assessments
were
completed,
with
short
8
term
defined
as
exposures
of
from
1
to
30
days.
For
the
agricultural
crop
scenarios,
the
only
short­
term
dermal
MOE
less
than
100
was
20,
for
the
Mixing/
Loading
Wettable
Powders
for
Aerial
Applications
with
the
baseline
attire
scenario
(
see
Table
5).
However,
with
the
addition
of
minimal
PPE,
specifically
using
chemical­
resistant
gloves
with
single
layer
of
clothing,
this
scenario
reached
an
MOE
of
greater
than
100.
All
of
the
inhalation
MOEs
were
greater
than
100
at
the
baseline
attire
scenario
(
See
Table
6).

In
order
to
assess
occupational
post­
application
exposure,
the
amount
of
transferable
residues
a
worker
could
be
exposed
to
was
examined.
Since
there
are
no
chemical­
specific
data
for
the
sabadilla
alkaloids,
conservative
values
for
the
transfer
coefficients
were
used
to
numerically
represent
the
post­
application
exposures
an
individual
would
receive.
The
amounts
of
pesticide
that
can
rub
off
on
the
skin
are
measured
using
techniques
that
specifically
determine
the
amount
of
residues
on
treated
leaves
or
other
surfaces
(
i.
e.,
transferable
residues),
rather
than
the
total
residues
contained
both
on
the
surface
and
absorbed
into
treated
leaves.
The
result
yields
an
estimated
transfer
coefficient
that
is
used
to
numerically
represent
the
postapplication
exposures
that
an
individual
would
receive.
Transfer
coefficients
are
related
to
specific
worker
activities,
which
are
related
to
specific
crops,
for
sabadilla
alkaloids,
citrus,
avocados,
and
mangoes.
To
cultivate,
grow,
and
maintain
these
crops,
a
variety
of
cultural
practices
are
required.
These
practices
are
varied
and
typically
involve
light
to
heavy
contact,
with
immature
plants
as
well
as
with
more
mature
plants.
Transfer
coefficient
values
are
selected
to
represent
this
range
of
exposures
and
are
placed
in
1
of
5
generic
categories:
very
low
exposure,
low
exposure,
medium
exposure,
high
exposure,
and
very
high
exposure.

In
order
to
define
the
amount
of
transferable
residues
to
which
individuals
can
be
exposed,
all
of
the
various
post­
application
agricultural
crop
scenarios
were
evaluated
using
the
assumption
that
20
percent
of
the
application
rate
is
initially
available
as
a
dislodgeable
foliar
residue
and
10
percent
of
that
residue
dissipates
daily.
The
approach
used
to
reduce
post­
application
risks
is
referred
to
as
the
Restricted
Entry
Interval
(
REI).
The
REI
is
a
time
period
following
a
pesticide
application
during
which
entry
into
the
treated
area
is
restricted.
The
REIs
calculated
for
the
varying
levels
of
exposure
to
sabadilla
alkaloids
are
all
less
than
24
hours
and
indicate
that
there
is
little
risk
to
workers
exposed
following
application.
In
addition
the
current
label
for
the
one
end­
use
product
does
list
an
REI
of
24
hours.
9
Table
5.
Short­
Term
Dermal
Occupational
Handler
Risks
Exposure
Scenario
Application
Ratea
(
lb
ai/
acre)
Area
Treated
Dailyb
(
acres)
Unit
Exposures
Baseline
Attirec
MOEg
PPE
MOEg
Engineering
Controle
MOEg
Baseline
(
mg/
lb
ai)
PPE
(
mg/
lb
ai)
Engineering
Controls
(
mg/
lb
ai)

Single
Layer
plus
Gloves
Double
Layer
plus
gloves
Single
Layer
plus
Glovesd
Double
Layer
plus
Gloves
Mixer/
Loader
Mixing/

Loading
Wettable
Powders
for
Aerial
Applications
0.03
350
3.7
0.17
N/
A
N/
A
20
370
N/
A
N/
A
Mixing/

Loading
Wettable
Powders
for
Airblast
Applications
0.04
40
3.7
N/
A
N/
A
N/
A
130
N/
A
N/
A
N/
A
Applicator
Applying
Liquid
Sprays
via
Aerial
Equipment
0.03
350
No
Data
No
Data
No
Data
0.005
No
Data
No
Data
No
Data
15,158
Applying
Liquid
Sprays
via
Airblast
Equipment
0.04
40
0.36
N/
A
N/
A
N/
A
1,283
N/
A
N/
A
N/
A
Flagger
Flagging
for
Liquid
Sprays
via
Aerial
Equipment
0.03
350
0.011
No
Data
N/
A
N/
A
6,647
No
Data
N/
A
N/
A
a
Application
rates
are
the
maximum
application
rates
determined
from
the
EPA
registered
label
for
sabadilla
alkaloids
(
see
Table
4).

b
Amount
handled
per
day
values
are
estimates
of
acres
treated
daily.

c
Baseline
attire
is
long­
sleeve
shirt,
long
pants,
shoes
and
socks,
and
no
gloves.

d
PPE­
single
layer
plus
gloves
is
baseline
attire
plus
chemical­
resistant
gloves.

e
Engineering
Controls:
Closed
mixing/
loading
system,
enclosed
cab,
or
enclosed
cockpit.

g
Dermal
MOE
=
NOEL
(
11
mg/
kg/
day)
/
dermal
daily
dose
(
mg/
kg/
day),
where
dermal
dose
=
daily
unit
exposure
(
mg/
lb
ai)
x
application
rate
x
amount
handled
per
day
/
body
weight
(
70
kg
adult).
10
Table
6.
Short­
Term
Inhalation
Occupational
Handler
Risks
Exposure
Scenario
Application
Ratea
(
lb
ai/
acre)
Area
Treated
Dailyb
(
acres)
Unit
Exposures
Baseline
Attirec
MOEf
PPE
MOEf
Engineering
Controle
MOEf
Baseline
(
µ
g/
lb
ai)
PPE
­

80%
Respirator
(
µ
g/
lb
ai)
Engineering
Controls
(
µ
g/
lb
ai)
80%
Respiratord
Mixer/
Loader
Mixing/
Loading
Wettable
Powders
for
Aerial
Applications
0.03
350
43
N/
A
N/
A
1,750
N/
A
N/
A
Mixing/
Loading
Wettable
Powders
for
Airblast
Applications
0.04
40
43
N/
A
N/
A
11,194
N/
A
N/
A
Applicator
Applying
Liquid
Sprays
via
Aerial
Equipment
0.03
350
No
Data
No
Data
0.068
No
Data
No
Data
1,072,720
Applying
Liquid
Sprays
via
Airblast
Equipment
0.04
40
4.5
N/
A
N/
A
107,272
N/
A
N/
A
Flagger
Flagging
for
Liquid
Sprays
via
Aerial
Equipment
0.03
350
0.35
N/
A
N/
A
209,880
N/
A
N/
A
a
Application
rates
are
the
maximum
application
rates
determined
from
the
EPA
registered
label
for
sabadilla
alkaloids
(
see
Table
4).

b
Amount
handled
per
day
values
are
estimates
of
acres
treated
daily.

c
Baseline
attire
is
no
respirator.

d
PPE­
80%
Respirator
is
a
quarter­
face
dust/
mist
respirator
(
that
provides
an
80%
protection
factor).

e
Engineering
Controls
are
closed
mixing/
loading
systems,
enclosed
cab,
or
enclosed
cockpit.

f
Inhalation
MOE
=
NOEL
(
11
mg/
kg/
day)
/
inhalation
daily
dose
(
mg/
kg/
day),
where
inhalation
dose
=
daily
unit
exposure
(
µ
g/
lb
ai)
x
application
rate
x
amount
handled
per
day
x
conversion
factor
(
1mg/
1,000
µ
g)
/
body
weight
(
70
kg
adult).
11
VI.
Dietary
(
Food)
Exposure:

Acute
and
chronic
dietary
exposure
assessments
were
conducted
for
sabadilla
alkaloids
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
2.03),
which
incorporates
consumption
data
from
US
Department
of
Agriculture
(
USDA)
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
The
1994­
96
and
1998
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
EPA­
defined
food
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
not
otherwise
specified
(
N/
S);
baked;
or
wheat
flour
­
cooked;
fresh
or
N/
S,
baked)
using
publicly
available
recipe
translation
files
developed
jointly
by
USDA/
Agricultural
Research
Service
and
EPA.
For
the
chronic
exposure
assessment,
consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups,
but
for
the
acute
exposure
assessment
are
retained
as
individual
consumption
events.
Based
on
analysis
of
the
1994­
96
and
1998
CSFII
consumption
data,
which
took
into
account
dietary
patterns
and
survey
respondents,
the
Agency
concluded
that
it
is
most
appropriate
to
report
risk
for
the
following
population
subgroups:
the
general
U.
S.
population,
all
infants
(<
1
year
old),
children
1­
2
years
old,
children
3­
5,
children
6­
12,
youth
13­
19,
adults
20­
49,
females
13­
49,
and
adults
50+
years
old.

For
chronic
dietary
exposure
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food­
form
(
e.
g.,
orange
or
orange
juice)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
The
exposure
is
expressed
in
mg/
kg
body
weight/
day,
and
as
a
percent
of
the
acute
and
chronic
Population
Adjusted
Dose
(
cPAD).
The
value
for
the
PAD
was
taken
as
equal
to
the
Reference
Dose
(
RfD)
of
0.11
mg/
kg/
day,
derived
from
the
oral
NOAEL
of
11
mg/
kg/
day
from
the
90­
day
feeding
study
in
the
rat,
with
a
Safety
Factor
of
100
applied
to
determine
the
RfD.
This
exposure
estimation
procedure
for
dietary
exposures
is
performed
for
each
population
subgroup.

For
acute
exposure
assessments,
one­
day
food
consumption
data
are
used
on
an
individual
basis.
The
reported
consumption
amounts
of
each
food
item
can
be
multiplied
by
a
residue
point
estimate
and
summed
to
obtain
a
total
daily
pesticide
exposure
for
a
deterministic
exposure
assessment,
or
"
matched"
in
multiple
random
pairings
with
residue
values
and
then
summed
in
a
probabilistic
assessment.
The
resulting
distribution
of
exposures
is
expressed
as
a
percentage
of
the
acute
PAD
(
aPAD)
on
both
a
user
(
i.
e.,
those
who
reported
eating
relevant
commodities/
food
forms)
and
a
per­
capita
(
i.
e.,
those
who
reported
eating
the
relevant
commodities
as
well
as
those
who
did
not)
basis.

Since
there
were
no
available
residue
data
for
the
sabadilla
alkaloids
in
the
respective
food
commodities,
in
conducting
this
assessment,
the
Agency
has
utilized
a
screening
model,
the
inert
screening
level
assessment,
to
estimate
the
residue
levels
and
applied
them
to
citrus,
avocados,
and
mangoes.
The
screening
level
assessment
uses
the
following
criteria
in
selecting
and
assigning
residue
values:

°
A
group
of
57
of
the
most
"
significant"
active
ingredients
were
considered.
These
active
ingredients
included
substances
in
the
insecticide
(
20)
,
fungicide
(
17),
and
herbicide
class
(
20),
and
were
selected
based
on
a
overall
ranking
scheme
that
included
the
following
components:
°
Overall
Use 
Based
on
1999
data
for
active
ingredient
use
(
in
lbs/
yr).
(
All
herbicides
at
>
5
million
lbs/
yr,
and
all
fungicides
and
insecticides
at
>
1
million
lbs/
yr
were
included.)
°
Use
on
crops
that
are
significant
contributors
to
diet.
(
All
active
ingredients
which
had
12
substantial
use
on
crops
that
make
up
the
"
Top
25
"
foods
most
commonly
consumed
in
the
diet
of
children
were
included.)
°
Use
on
specific
crops.
(
Crop­
by­
crop
pesticide
use
information
was
evaluated
to
identify
the
most
frequently
used
active
ingredients.)
°
Actual
residue
monitoring
studies
(
active
ingredients
with
the
highest
frequency
of
detection).
°
Tolerances
for
the
57
active
ingredients
were
examined
for
each
of
the
representative
crops
in
the
Agency's
crop
group
designations
[
40
CFR
180.41],
and
for
all
crops
not
included
in
a
crop
group.
Where
there
were
multiple
tolerances
for
a
given
crop
or
commodity,
the
highest
tolerance
was
chosen
as
the
residue
level
for
the
model.
°
Non­
representative
crops
within
each
crop
group
were
matched
to
their
most­
closely
related
representative
crop.

For
these
assessments,
the
screening­
level
residue
estimates
were
modified
in
two
ways.
First,
residues
were
multiplied
by
four
because
the
screening
level
assessment
assumes
application
rates
of
approximately
5
lbs/
A
and
the
Veratran
D
label
lists
a
maximum
application
rate
of
20
lbs/
A
(
20
lbs/
A
÷
5
lbs/
A
=
4).
Second,
the
residue
estimates
were
multiplied
by
0.05
to
account
for
the
fact
that
the
sabadilla
alkaloids
comprise
only
0.2%
of
the
Veratran
D
formulation.
This
5%
factor
is
considered
to
be
a
conservative
adjustment
for
the
percentage
of
active
ingredient
in
the
formulation.
The
inputs
to
the
dietary
exposure
model
are
included
in
Attachment
1.

The
Agency
is
generally
not
concerned
when
exposure
estimates
are
less
than
100%
of
the
aPAD
or
cPAD.
As
summarized
in
Table
7,
the
exposure
estimates
for
the
sabadilla
alkaloids
are
about
38%
or
less
than
the
aPAD,
and
about
8%
or
less
than
the
cPAD,
for
each
of
the
population
subgroups.

Table
7.
Summary
of
Dietary
Exposure
and
Risk
for
Sabadilla
Alkaloids
Population
Subgroup*
Acute
Dietary
(
95th
Percentile)
Chronic
Dietary
Cancer
Dietary
Exposure
(
mg/
kg/
day)
%
aPAD*
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD*
Dietary
Exposure
(
mg/
kg/
day)
Risk
General
U.
S.
Population
0.012939
12
0.002540
3
N/
A
N/
A
All
Infants
(<
1
year
old)
0.003651
4
0.001220
2
Children
1­
2
years
old
0.041061
38
0.008229
8
Children
3­
5
years
old
0.030861
28
0.006498
6
Children
6­
12
years
old
0.019631
18
0.004028
4
Youth
13­
19
years
old
0.014617
14
0.002693
3
Adults
20­
49
years
old
0.010098
10
0.001804
2
Adults
50+
years
old
0.008154
8
0.001816
2
Females
13­
49
years
old
0.011084
10
0.001981
2
VII.
Drinking
Water
Exposure:

Tier
I
Estimated
Drinking
Water
Concentrations
(
EDWCs)
for
sabadilla
alkaloids
were
calculated
by
utilizing
the
FIRST
V.
1.0
(
surface
water)
and
SCIGROW
V.
2.3
(
ground
water)
models
for
use
in
the
human
health
risk
assessment.
For
surface
waters,
the
estimated
peak
concentrations
ranged
between
1.62
13
ppb
and
1.80
ppb,
and
the
annual
average
concentrations
ranged
between
0.05
ppb
and
0.10
ppb,
depending
on
the
individual
alkaloid
assessed
(
Table
8).
The
estimated
ground
water
concentrations,
suitable
for
both
peak
and
annual
average
concentrations,
are
all
about
0.0007
ppb
(=
0.7
parts
per
trillion),
regardless
of
the
individual
alkaloid
assessed.
These
values
represent
"
conservative"
(
i.
e.,
highend
estimates
of
the
concentrations
of
sabadilla
alkaloids
that
could
be
found
in
surface
and
ground
water
due
to
the
use
on
citrus,
avocados,
and
mangoes,
the
crops
on
the
current
label.
There
are
no
available
monitoring
data
for
assessing
these
EDWCs
in
either
surface
waters
or
ground
water.

Table
8.
Estimated
Environmental
Concentrations
(
ppb)
of
Sabadilla
Alkaloids
in
Surface
and
Groundwater
at
Three
Applications
of
0.04
lb/
acre
with
10­
day
Intervals.

Scenario
Peak
(
ppb)
Long­
Term
Average,
Peak
(
ppb)

Annual
4­
day
21­
day
60­
day
90­
day
Surface
water
drinking
water
(
FIRST)
1
1.62
­
1.80
0.05
­
0.10
Ambient
surface
water
(
GENEEC)
1
0.38
­
0.58
0.27
­
0.50
0.07
­
0.23
0.03
­
0.09
0.02
­
0.06
Groundwater
drinking
water
(
SCI­
GROW)
0.0007
1
The
range
of
concentrations
represent
model
output
for
four
of
the
sabadilla
alkaloids
(
cevadine,
veratridine,
sabadine,
sabadinine).

VIII.
Aggregate
Assessment:

The
Food
Quality
Protection
Act
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
[
FFDCA,
Section
408(
b)(
2)(
A)(
ii)]
require
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
typically
includes
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non­
occupational
sources
of
exposure.
For
an
aggregate
assessment
of
sabadilla
alkaloids,
the
only
significant
exposure
routes
are
oral
exposure
through
food
and
water
consumption,
because
there
are
no
registered
residential
uses
or
other
nonoccupational
sources
of
exposure.

To
determine
the
maximum
contribution
allowed
from
water
in
the
diet,
the
Agency
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food
to
determine
a
"
drinking
water
level
of
comparison"
(
DWLOC).
The
modeled
drinking
water
estimates
are
then
compared
to
the
DWLOC
to
ensure
that
they
do
not
exceed
this
level.
Acute
and
chronic
dietary
exposure
assessments
were
conducted,
and
show
that
sabadilla
alkaloids
represent
a
small
percent
of
the
PAD,
specifically,
less
than
or
equal
to
38%
of
the
aPAD,
and
8%
of
the
cPAD,
for
all
population
subgroups.
The
Agency
is
generally
not
concerned
when
dietary
exposure
estimates
are
less
than
100%
of
the
PAD.
In
addition,
drinking
water
concentrations
are
also
very
low.
Estimated
sabadilla
alkaloid
concentrations
in
drinking
water
range
between
1.62
and
1.80
ppb
for
the
annual
peak
concentration,
and
0.05
and
0.10
ppb
for
the
annual
mean
concentration.

Since
the
dietary
contribution
is
significantly
below
the
PAD
and
the
estimated
drinking
water
exposure
levels
are
minimal,
the
Agency
considers
it
very
unlikely
that
levels
of
concern
would
be
reached
from
the
14
combination
of
these
two
exposure
sources.
As
support
for
this
position,
the
chronic
risk
estimates
for
exposure
to
food
and
drinking
water
sources
for
the
most
sensitive
population
subgroup
(
children
1­
2
years
old)
and
for
the
general
U.
S.
population
have
been
determined
(
see
Table
1).
Considering
that
the
estimated
environmental
concentrations
of
sabadilla
alkaloids
are
significantly
below
the
DWLOC
for
the
most
sensitive
population
subgroup,
and
the
low
production
volume
and
total
amount
applied
of
this
chemical,
the
risks
associated
with
food
and
drinking
water
exposures
to
sabadilla
alkaloids
are
not
of
concern
to
the
Agency.

Table
9.
Summary
of
Aggregate
Risk
Estimates
for
Chronic
Food
and
Water
Exposures
to
Sabadilla
Alkaloids
Population
Subgroup
Chronic
PAD
(
mg/
kg/
d)
Food
Exposure
(
mg/
kg/
d)
Allowable
Water
Exposure
(
mg/
kg/
d)
Annual
Peak
in
Drinking
Water
(
ppb)
Annual
Mean
in
Drinking
Water
(
ppb)
DWLOC
(
ppb)

Children
1­
2
yrs.
old
0.11
0.008229
0.101771
1.80
0.10
1020
General
U.
S.
Population
0.11
0.002540
0.10746
1.80
0.10
3760
IX.
Risk
Characterization:

The
assessments
of
occupational
handler
and
post­
application
exposures
to
sabadilla
alkaloids
indicate
that
there
is
very
little
risk
associated
with
its
use
as
an
insecticide
on
agricultural
crops.
Only
one
handler
scenario
indicated
an
MOE
of
<
100,
an
MOE
of
20
associated
with
dermal
exposures
for
mixer/
loaders
handling
wettable
powders
for
aerial
applications
with
baseline
attire
(
assumes
no
gloves).
However,
according
to
the
label,
applicators
and
other
handlers
must
wear
long­
sleeved
shirts,
long
pants,
waterproof
gloves
and
shoes
plus
socks.
According
to
the
occupational
handler
assessment
for
dermal
exposures,
if
gloves
are
worn,
the
MOE
will
exceed
100,
and
no
longer
of
concern.
Inhalation
risks
were
also
found
to
be
low,
with
all
scenarios
resulting
in
MOEs
greater
than
100.
For
post­
application
scenarios,
the
REIs
calculated
were
all
less
than
24
hours.
The
product
label
states
that
worker
entry
into
treated
areas
is
restricted
for
24
hours
after
application
and
that
early
entry
to
treated
areas
requires
the
use
of
PPE.
Therefore,
post­
application
exposure
to
workers
is
not
of
concern.

X.
Environmental
Fate/
Ecotoxicity/
Drinking
Water
Considerations:

Very
little
measured
data
are
available
on
the
physical
and
chemical
properties
or
the
environmental
fate
of
sabadilla
alkaloids.
The
major
route
of
dissipation
and
degradation
appears
to
be
photolysis,
since
hydrolysis
is
predicted
to
occur
at
considerably
slower
rates
(
days
to
years)
and
the
biodegradation
data
for
related
chemicals
suggest
that
the
sabadilla
alkaloids
may
be
slow
to
degrade
in
the
environment.
Volatilization
from
water
is
probably
not
important,
since
the
vapor
pressure
values
and
Henry's
law
constants
are
reported
to
be
"
negligible"
in
the
EFED
Science
Assessment
(
although
the
specific
QSAR
estimated
values
were
not
actually
reported).
While
no
experimental
data
are
available
on
soil
mobility,
the
physical
and
chemical
properties
of
sabadilla
alkaloids
suggest
low
mobility
in
soil,
and
that
sorption
to
suspended
solids
and
sediment
would
be
expected
to
occur
if
sabadilla
alkaloids
are
released
to
water.

Concentrations
of
sabadilla
alkaloids
in
surface
water
were
estimated
for
the
exposures
for
aquatic
15
organisms
by
utilizing
the
Tier
1
and
GENEEC
v.
2.0
model
(
see
Table
8).
Applications
of
sabadilla
alkaloids
were
modeled
at
the
maximum
labeled
rate
of
0.04
lbs
a.
i./
acre
for
three
applications
with
two
10­
day
intervals.
Model
runs
were
conducted
for
four
of
the
sabadilla
alkaloids:
cevadine,
veratridine,
sabadine,
and
sabadinine.
Sabadilla
alkaloid
concentrations
in
ambient
surface
water
(
standard
small
static
water
body
scenario
for
aquatic
exposure)
range
between
0.38
­
0.58
ppb,
depending
on
the
individual
alkaloid
(
Table
8).
The
long­
term
average
concentrations
decline
over
time
for
each
alkaloid.

The
available
information
on
the
toxicity
of
sabadilla
alkaloids,
the
registered
uses
and
areas
in
which
these
compounds
are
applied,
physical­
chemical
properties,
and
application
methods
have
been
considered
in
characterizing
environmental
exposures
and
ecological
risks
related
to
labeled
uses.
Available
studies
have
been
conducted
on
formulations
that
contained
one
or
more
alkaloids.
Data
gaps
were
addressed
using
quantitative
structure
activity
relationships
(
QSARs).
Available
and
estimated
data
on
toxicity
and
exposure
indicate
that
sabadilla
alkaloids
present
minimal
risks
to
fish
on
an
acute
basis,
based
on
the
estimated
exposure
concentrations
(
EECs)
for
the
fish
species
from
GENEEC
model
(
see
Table
8).

Estimates
of
the
toxicity
to
small
mammals
was
assessed
based
on
the
available
toxicity
studies
in
the
rat,
from
oral
feeding
studies
with
sabadilla
seed
technical,
comprised
of
4.83%
total
sabadilla
alkaloids.
Based
on
the
dosages
reported
in
ppm,
the
EFED
Science
Assessment
computed
the
corresponding
doses
in
mg
total
sabadilla
alkaloids
(
TSA)
/
kg­
bw/
day,
from
the
90­
day
feeding
study,
14­
day
range­
finding
study
for
the
developmental
study,
and
the
developmental
toxicity
study.
Based
on
these
studies,
the
lowest
LD50
to
the
rat
was
estimated
to
be
44
mg
TSA/
kg­
bw/
day,
from
the
14­
day
range­
finding
study.
Based
on
the
limited
data
set
available,
the
EFED
Science
Assessment
concluded
that
the
sabadilla
alkaloids
may
present
a
potential
for
acute
RQ
risks
to
small
(
15
gram)
mammals
feeding
exclusively
on
short
grass.
In
addition,
there
are
potential
endangered
species
RQ
risks
to
medium
(
35
gram)
and
large
(
100
gram)
mammals
feeding
exclusively
on
short
grass,
on
tall
grass,
and
feeding
on
broadleaf/
forage
plants
and
small
insects,
following
applications
at
the
maximum
allowable
rate
and
shortest
interval.
However,
when
the
risk
assessments
are
performed
utilizing
the
typical
application
rates,
longer
intervals
between
applications,
and
shorter
half­
lives
(
based
on
rapid
photodegradation),
the
results
suggest
only
minimal
risks,
with
the
only
RQ
risk
exceedances
being
for
small
endangered
mammals
feeding
only
on
the
short
grass
compared
with
no
endangered
species
risks
for
the
other
4
types
of
terrestrial
exposure
pathways.
For
this
typical
use
scenario,
the
small
mammals
feeding
on
short
grass
exhibited
an
RQ
of
0.14,
while
the
endangered
species
RQ
of
concern
is
greater
than
0.10,
a
difference
which
is
considered
insignificant.
Note
also
that
the
EFED
Science
Assessment
stated
that
the
toxicity
data
"
should
be
used
in
risk
assessment
with
caution
since
they
are
based
on
a
very
limited
number
of
data
points
from
a
single
study
with
female
rats
of
only
one
strain."
In
addition,
the
end­
point
selected
is
based
on
the
total
sabadilla
alkaloids
(
TSA),
whereas
the
only
end­
use
product
currently
registered
has
a
label
concentration
of
0.2%
sabadilla
alkaloids,
and
would
be
mixed
with
water
prior
to
being
applied
to
the
soils
and
grasses
utilized
in
the
terrestrial
risk
assessment.
Furthermore,
there
is
only
a
small
volume
of
end­
use
product
used
on
an
annual
basis,
on
a
limited
number
of
minor
use
crops,
in
a
limited
geographical
area,
further
suggesting
that
the
ecological
risks
would
not
be
expected
to
be
very
wide­
spread.
Note
also,
with
respect
to
endangered
species,
this
is
a
screening
level
and/
or
qualitative
assessment,
and
does
not
constitute
any
findings
under
the
Endangered
Species
Act.

A
single
48­
hour
acute
toxicity
study
with
the
honey
bee
suggests
that
sabadilla
alkaloids
are
relatively
non­
toxic
to
nontarget
insects
at
maximum
application
rates.
Risks
to
terrestrial
plants
cannot
be
quantified
due
to
a
lack
of
phytotoxicity
data.
Similarly,
no
data
were
available
to
quantify
the
acute
or
chronic
risks
to
birds,
but
the
available
acute
ecotoxicity
data
do
not
suggest
a
substantial
potential
for
adverse
effects.
Furthermore,
QSAR
estimates
on
the
alkaloids
indicate
no
chronic
toxicity
concerns
for
fish
and
green
algae,
and
no
acute
concerns
for
daphnia.
16
XI.
Cumulative
Exposure:

Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
If
chemicals
are
structurally
related
and
all
are
low
toxicity
chemicals,
then
the
risks
either
separately
or
combined
should
also
be
low.

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
sabadilla
alkaloids
have
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
sabadilla
alkaloids
and
any
other
substances,
and
sabadilla
alkaloids
do
not
appear
to
produce
toxic
metabolites
produced
by
other
substances.

For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
sabadilla
alkaloids
have
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
the
Agency's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

XII.
Tolerance
Reassessment:

The
current
tolerance
exemption
for
sabadilla
is
at
40
CFR
180.905(
a)(
8),
and
defined
as
exempt
from
the
requirement
of
a
tolerance
when
applied
to
growing
crops.
This
pesticide
is
not
exempt
from
the
requirement
of
a
tolerance
when
applied
to
a
crop
at
the
time
of
or
after
harvest.
This
RED
is
deemed
to
have
reassessed
this
tolerance
at
40
CFR
180.905(
a)(
8)
and
found
it
acceptable.

XIII.
References:

California
Environmental
Protection
Agency
(
CALEPA).
2001.
Summary
of
Toxicology
Data:
Sabadilla
Alkaloids.
Department
of
Pesticide
Regulation,
Medical
Toxicology
Branch.

Environmental
Fate
and
Effects
Division.
2004.
Environmental
Fate
and
Effects
Division's
Science
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
[
for
Sabadilla
Alkaloids].
D304789.
July
9,
2004.

Environmental
Protection
Agency
(
EPA).
1993.
Data
Evaluation
Records:
Veratran
D,
containing
Sabadilla
Alkaloids:
Data
Evaluation
Reports
of
Toxicity
Studies.
Reviewed
by
Patricia
McLaughlin,
Ph.
D.,
Section
IV,
Toxicology
II
Branch,
Hazard
Evaluation
Division.

Environmental
Protection
Agency
(
EPA).
1996.
Data
Evaluation
Records:
EPA
REG
#
39834­
1.
Sabadilla
Alkaloids:
Data
Evaluation
Reports:
Toxicity,
acute.
Reviewed
by
David
L.
Ritter,
Registration
Support
Branch,
Precautionary
Review
Section,
Registration
Division.
17
Environmental
Protection
Agency
(
EPA).
2004.
Memorandum:
Review
for
Acute
Inhalation
Study
for
EPA
Reg.
No.:
39834­
1/
Veratran
D.
Maria
Rivera
Piansay,
Product
Reregistration
Branch,
Special
Review
and
Reregistration
Division.

EPIWIN
 
.
2000.
Estimation
Program
Interface,
Version
3.11.
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Washington,
D.
C.
Available
at:
http://
www.
epa.
gov/
oppt/
exposure/
docs/
episuitedl.
htm.

Gunther,
F.
A.,
Westlake,
W.
E.,
Jaglan,
P.
S.
1968.
Reported
solubilities
of
738
pesticide
chemicals
in
water.
Res.
Rev.
20:
1­
148.

Science
Advisory
Council
(
SAC)
for
Exposure
(
2000)
Policy
Memo
#
003.1:
Agricultural
Transfer
Coefficients
(
August
17,
2000).

Tomlin,
C.
2003.
The
Pesticide
Manual,
a
World
Compendium.
13th
ed.
D.
S.
Ed.
The
British
Crop
Protection
Council.

Toxnet.
2004.
Hazardous
Substances
Data
Bank.
Veratridine
and
Veratramine.
National
Library
of
Medicine.
http://
www.
toxnet.
nlm.
nih.
gov/
cgi­
bin/
sis/
htmlgen.
HSDB.

Appendix
1.
BEAD
Screening
Level
Estimate
of
Agricultural
Uses
Sabadilla
Alkaloids
The
tables
below
contain
"
screening
level"
usage
data
for
agricultural
crops.
This
information
is
retrieved
from
our
principal
agricultural
pesticide
usage
databases.
At
the
present
time
data
from
1998
to
2002
is
being
used.

All
numbers
reported
are
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.

Maximum
percent
of
crop
treated
is
the
highest
observed
percent
crop
treated
during
this
time
period.
For
some
crops
there
may
have
been
only
one
or
two
observations
and
it
is
quite
possible
that
if
usage
information
had
been
available
for
more
years
that
higher
usage
might
have
been
observed.
This
situation
is
more
likely
to
occur
with
low
acreage
crops.

'(
CA
only)'
indicates
information
was
available
only
for
California.
California
requires
reporting
of
all
agricultural
pesticide
use.
Their
database
may
indicate
small
amounts
of
usage
of
a
pesticide
on
crops
on
which
the
pesticide
is
not
registered.
Possible
reasons
for
this
include:
­
This
use
may
actually
have
occurred
either
as
an
unregistered
use
or
as
an
experimental
or
other
use
in
which
the
crop
was
not
intended
for
consumption.
­
Data
input
errors
may
have
occurred
and
either
the
crop
or
the
pesticide
is
incorrect
in
the
database.
18
Use
of
the
chemical
on
crops
for
which
only
California
use
is
reported
may
possibly
have
occurred
in
other
states.

In
some
cases
the
percent
crop
treated
column
is
blank.
This
is
because
information
on
acres
grown
was
not
readily
available.

Some
of
the
numbers
may
be
based
on
information
that
does
not
cover
all
50
states.
Therefore,
it
is
possible
that
if
the
remaining
(
usually
minor
states
for
the
crop)
had
been
included
that
pounds
of
active
ingredient
would
be
slightly
higher.

Arthur
Grube
308­
8095
Last
revised
Feb
06,
2004
19
SAS
Thursday,
June
24,
2004
15:
04
1
Screening
Level
Estimates
of
Agricultural
Uses
of
sabadilla
alkaloids
Sorted
Alphabetically
Pounds
of
Percent
of
OBS
Crop
Active
Ingredient
Crop
Treated
Avg
Max
1
Avocados
<
500
10
20
2
Grapefruit
<
500
<
1
5
3
Lemons
<
500
5
5
4
Limes
(
CA
only)
<
500
5
Mangoes
(
CA
only)
<
500
6
Oranges
<
500
<
1
<
2.5
7
Persimmons
(
CA
only)
<
500
8
Stone
Fruit
(
CA
only)
<
500
9
Tangelos
(
CA
only)
<
500
10
Tangerines
(
CA
only)
<
500
______________________________________

All
numbers
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.
'(
CA
only)'
indicates
information
was
available
only
for
California.
Use
of
sabadilla
alkaloids
on
this
crop
may
also
have
occurred
in
other
states.

(
slua0001.
sas
sabadilla
alkaloids
)
20
Appendix
2.
Sabadilla
Alkaloids:
Acute
and
Chronic
Dietary
Exposure
Assessments
21
Appendix
2­
1.
Dietary
Exposure
Model
Inputs
Filename:
C:\
Documents
and
Settings\
MDOHERTY\
My
Documents\
Chemistry
Reviews\
DEEM
Runs\
Veratran.
R98
Chemical:
Veratran
RfD(
Chronic):
.5
mg/
kg
bw/
day
NOEL(
Chronic):
50
mg/
kg
bw/
day
RfD(
Acute):
.5
mg/
kg
bw/
day
NOEL(
Acute):
50
mg/
kg
bw/
day
Date
created/
last
modified:
06­
22­
2004/
09:
32:
21/
8
Program
ver.
2.03
Comment:
Factor
2
of
0.05
is
to
acknowledge
that
the
active
ingredient
is
only
0.2%
of
the
formulation.
The
5%
factor
is
a
conservative
adjustment
for
the
low
concentration.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Commodity
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
95000200
O
Avocado
40.000000
1.000
0.050
10
ppm
Full
comment:
10
ppm
screen
x
4
(
applic.
rate
factor)
10001060
10
Citrus
citron
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10001070
10
Citrus
hybrids
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10001080
10
Citrus,
oil
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10001800
10
Grapefruit
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10001810
10
Grapefruit,
juice
20.000000
2.100
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10001970
10
Kumquat
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10001990
10
Lemon
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002000
10
Lemon,
juice
20.000000
2.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002001
10
Lemon,
juice­
babyfood
20.000000
2.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002010
10
Lemon,
peel
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002060
10
Lime
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002070
10
Lime,
juice
20.000000
2.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002071
10
Lime,
juice­
babyfood
20.000000
2.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
95002150
O
Mango
12.000000
1.000
0.050
3
ppm
Full
comment:
3
ppm
screen
x
4
(
applic.
rate
factor)
95002151
O
Mango­
babyfood
12.000000
1.800
0.050
3
ppm
Full
comment:
3
ppm
x
4;
Papaya
proc.
factor
95002160
O
Mango,
dried
12.000000
1.800
0.050
3
ppm
Full
comment:
3
ppm
x
4;
Papaya
proc.
factor
95002170
O
Mango,
juice
12.000000
1.500
0.050
3
ppm
Full
comment:
3
ppm
x
4;
Papaya
proc.
factor
95002171
O
Mango,
juice­
babyfood
12.000000
1.500
0.050
3
ppm
Full
comment:
3
ppm
x
4;
Papaya
proc.
factor
10002400
10
Orange
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002410
10
Orange,
juice
20.000000
1.800
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002411
10
Orange,
juice­
babyfood
20.000000
1.800
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10002420
10
Orange,
peel
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10003070
10
Pummelo
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10003690
10
Tangerine
20.000000
1.000
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
10003700
10
Tangerine,
juice
20.000000
2.300
0.050
5
ppm
Full
comment:
5
ppm
x
4
(
applic.
factor
22
Appendix
2­
2.
Summary
of
Acute
Screening
Dietary
Exposure
and
Risk
Estimates.

U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
VERATRAN
(
1994­
98
data)
Residue
file:
Veratran.
R98
Adjustment
factor
#
2
used.
Analysis
Date:
07­
15­
2004/
10:
52:
27
Residue
file
dated:
07­
15­
2004/
10:
39:
19/
8
NOEL
(
Acute)
=
50.000000
mg/
kg
body­
wt/
day
Daily
totals
for
food
and
foodform
consumption
used.
Run
Comment:
"
Factor
2
of
0.05
is
to
acknowledge
that
the
active
ingredient
is
only
0.2%
of
the
formulation.
The
5%
factor
is
a
conservative
adjustment
for
the
low
concentration."
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
U.
S.
Population:
0.012939
2.59
3864
0.030117
6.02
1660
0.067880
13.58
736
All
infants:
0.003651
0.73
13693
0.033202
6.64
1505
0.127654
25.53
391
Children
1­
2
yrs:
0.041061
8.21
1217
0.075365
15.07
663
0.136549
27.31
366
Children
3­
5
yrs:
0.030861
6.17
1620
0.056715
11.34
881
0.117429
23.49
425
Children
6­
12
yrs:
0.019631
3.93
2547
0.037060
7.41
1349
0.057776
11.56
865
Youth
13­
19
yrs:
0.014617
2.92
3420
0.029171
5.83
1714
0.049480
9.90
1010
Adults
20­
49
yrs:
0.010098
2.02
4951
0.019624
3.92
2547
0.046589
9.32
1073
Adults
50+
yrs:
0.008154
1.63
6132
0.014177
2.84
3526
0.027340
5.47
1828
Females
13­
49
yrs:
0.011084
2.22
4510
0.020354
4.07
2456
0.040903
8.18
1222
23
Appendix
2­
3.
Summary
of
Chronic
Screening
Dietary
Exposure
and
Risk
Estimates.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
VERATRAN
(
1994­
98
data)
Residue
file
name:
C:\
Documents
and
Settings\
MDOHERTY\
My
Documents\
Chemistry
Reviews\
DEEM
Runs\
Veratran.
R98
Adjustment
factor
#
2
used.
Analysis
Date
07­
15­
2004/
12:
39:
22
Residue
file
dated:
07­
15­
2004/
10:
39:
19/
8
Reference
dose
(
RfD,
Chronic)
=
.5
mg/
kg
bw/
day
COMMENT
1:
Factor
2
of
0.05
is
to
acknowledge
that
the
active
ingredient
is
only
0.2%
of
the
formulation.
The
5%
factor
is
a
conservative
adjustment
for
the
low
concentration.
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
RfD
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.002540
0.5%

U.
S.
Population
(
spring
season)
0.002574
0.5%
U.
S.
Population
(
summer
season)
0.002395
0.5%
U.
S.
Population
(
autumn
season)
0.002487
0.5%
U.
S.
Population
(
winter
season)
0.002719
0.5%

Northeast
region
0.003378
0.7%
Midwest
region
0.002338
0.5%
Southern
region
0.002202
0.4%
Western
region
0.002543
0.5%

Hispanics
0.003437
0.7%
Non­
Hispanic
whites
0.002289
0.5%
Non­
Hispanic
blacks
0.002920
0.6%
Non­
Hisp/
non­
white/
non­
black
0.003428
0.7%

All
infants
(<
1
year)
0.001220
0.2%
Nursing
infants
0.000442
0.1%
Non­
nursing
infants
0.001515
0.3%
Children
1­
6
yrs
0.006864
1.4%
Children
7­
12
yrs
0.003811
0.8%

Females
13­
19
(
not
preg.
or
nursing)
0.002555
0.5%
Females
20+
(
not
preg.
or
nursing)
0.001860
0.4%
Females
13­
50
yrs
0.002174
0.4%
Females
13+
(
preg./
not
nursing)
0.002493
0.5%
Females
13+
(
nursing)
0.002432
0.5%

Males
13­
19
yrs
0.002780
0.6%
Males
20+
yrs
0.001741
0.3%
Seniors
55+
0.001806
0.4%

Children
1­
2
yrs
0.008229
1.6%
Children
3­
5
yrs
0.006498
1.3%
Children
6­
12
yrs
0.004028
0.8%
Youth
13­
19
yrs
0.002693
0.5%
Adults
20­
49
yrs
0.001804
0.4%
Adults
50+
yrs
0.001816
0.4%
Females
13­
49
yrs
0.001981
0.4%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­