Page
1
of
28
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
MEMORANDUM
Date:
15­
September­
2005
Subject:
PP#
s
3E6699,
3E6780,
3E6782,
3E6802,
3E6804,
and
4E6811.
Application
of
Spinosad
to
Mint;
Banana;
Plantain;
Peanut;
Bulb
Vegetables;
Legume
Vegetables;
Forage,
Fodder,
and
Straw
of
Cereal
Grains
(
crop
group
16);
Grass
Forage,
Fodder,
and
Hay
(
crop
group
17);
and
Nongrass
Animal
Feeds
(
crop
group
18)
and
Application
of
Spinosad
for
Control
of
Fruit
Flies.
HED
Risk
Assessment.
DP
#
s
D310318,
D310858,
D310862,
D310876,
D310966,
and
D314168.
PC
Code
110003.
Decision
#
s
330536,
350741,
350878,
351404,
351405,
and
351510.

From:
Tom
Bloem,
Chemist
PV
Shah,
Ph.
D.,
Branch
Senior
Scientist
Mark
I.
Dow,
Ph.
D.,
Biologist
Registration
Action
Branch
1/
Health
Effects
Division
(
RAB1/
HED;
7509C)

Through:
PV
Shah,
Ph.
D.,
Branch
Senior
Scientist
RAB1/
HED
(
7509C)

To:
Daniel
Rosenblatt/
Barbara
Madden;
RM
05
Robert
Forest/
Sydney
Jackson;
RM
05
Registration
Division
(
RD;
7505C)

The
HED
of
the
Office
of
Pesticide
Programs
(
OPP)
is
charged
with
estimating
the
risk
to
human
health
from
exposure
to
pesticides.
The
RD
of
OPP
has
requested
that
HED
evaluate
hazard
and
exposure
data
and
conduct
dietary,
occupational,
residential,
and
aggregate
exposure
assessments,
as
needed,
to
estimate
the
risk
to
human
health
that
will
result
from
all
registered
and
proposed
uses
of
spinosad.
A
summary
of
these
findings
is
provided
in
this
document.
The
risk
assessment,
residue
chemistry
review,
and
dietary
exposure
assessment
were
provided
by
Tom
Bloem
of
RAB1;
the
hazard
characterization
was
provided
by
PV
Shah
of
RAB1;
the
occupational/
residential
exposure
and
risk
assessment
was
provided
by
Mark
Dow
of
RAB1;
and
the
drinking
water
assessment
was
provided
by
Ronald
Parker
of
the
Environmental
Fate
and
Effects
Division
(
EFED).

NOTE:
In
2002,
HED
completed
a
Section
3
risk
assessment
for
the
application
of
spinosad
to
herbs,
peanut,
caneberry,
grape,
fig,
and
root
and
tuber
vegetables
(
D284803,
D.
Vogel
et
al.,
15­
Aug­
2002).
The
current
document
contains
only
those
aspects
of
the
risk
assessment
which
are
affected
by
the
addition
of
the
proposed
spinosad
uses.
Page
2
of
28
Table
of
Contents
1.0
EXECUTIVE
SUMMARY
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3
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
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8
3.0
HAZARD
CHARACTERIZATION
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9
3.1
Endocrine
Disruption
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10
4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
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10
4.1
Summary
of
Registered
Uses
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10
4.2
Summary
of
Proposed
Uses
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10
4.3
Dietary
Exposure/
Risk
Pathway
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15
4.4
Water
Exposure
and
Risk
Pathway
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17
4.5
Dietary­
Exposure
Analysis
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18
4.7Non­
occupational
Off­
Target
Exposure
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19
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
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20
6.0
CUMULATIVE
RISK
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21
7.0
OCCUPATIONAL
EXPOSURE
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21
7.1
Handler
Exposure
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22
7.2
Post­
Application
Worker
Exposure
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25
7.3
Restricted
Entry
Interval
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25
8.0
DEFICIENCIES
/
DATA
NEEDS
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26
8.1
Toxicology
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26
8.2
Chemistry
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26
8.3
Occupational/
Residential
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26
Page
3
of
28
1.0
EXECUTIVE
SUMMARY
Background:
Spinosad
is
a
fermentation
product
of
Saccharopolyspora
spinosa,
a
naturally
occurring
soil
organism.
The
product
consists
of
two
related
active
ingredients:
Spinosyn
A
and
Spinosyn
D.
The
two
active
ingredients
differ
by
one
methyl
group
and
are
typically
present
at
an
85:
15
ratio
(
A:
D).
The
registrant
indicated
that
the
extact
mode
of
action
is
not
known
but
is
characterized
by
excitation
of
the
insect
nervous
system,
leading
to
involuntary
muscle
contractions,
prostration
with
tremors,
and
paralysis
(
effects
are
consistent
with
excitation
of
the
nicotinic
acetylcholine
receptors).
Spinosad
is
currently
registered
for
application
to
numerous
crops
with
tolerances
for
the
combined
residues
of
spinosyn
A
and
D
ranging
from
0.01­
200
ppm
(
40
CFR
180.495).

The
Interregional
Research
Project
No.
4
(
IR­
4)
is
requesting
the
following
spinosad
application
scenarios:
foliar
application
to
the
bulb
vegetable
crop
group,
banana,
plantain,
legume
forage,
and
mint;
removal
of
the
feeding
restriction
for
peanut
hay;
foliar
application
to
the
grass
forage,
fodder,
and
hay
group;
reduction
in
the
forage
(
from
7­
14
days
to
3
days),
fodder
(
from
14­
28
days
to
3
days),
and/
or
hay
(
from
14­
28
days
to
3
days)
preharvest
intervals
(
PHIs)
for
sorghum,
milo,
pearl
millet,
proso
millet,
grain
amaranth,
teosinte,
corn
(
field,
sweet,
popcorn,
and
seed
corn),
and
small
grains
(
wheat,
barley,
rye,
oats,
and
triticale);
and
application
to
all
crops
for
control
of
fruit
flies.
In
conjunction
with
these
requests,
the
petitioner
is
requesting
the
establishment
of
the
following
tolerances:

Vegetable,
bulb,
except
green
onion,
group
3
.
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.
0.1
ppm
Onion,
green
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2.0
ppm
Banana
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.
.
0.25
ppm
Spearmint,
tops
.
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.
5.0
ppm
Peppermint,
tops
.
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.
5.0
ppm
Peanut,
hay
.
.
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.
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.
.
25
ppm
Animal
feed,
nongrass,
group
18,
forage
.
.
.
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.
.
.
.
.
.
.
.
20
ppm
Animal
feed,
nongrass,
group
18,
hay
.
.
.
.
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.
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.
.
.
.
25
ppm
Grass,
forage,
fodder
and
hay,
group
17,
forage
.
.
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.
.
.
.
.
.
.
1.5
ppm
Grass,
forage,
fodder
and
hay,
group
17,
hay
.
.
.
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.
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5
ppm
Corn,
field,
stover
.
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.
.
5
ppm
Corn,
sweet,
stover
.
.
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.
.
.
.
5
ppm
Corn,
pop,
stover
.
.
.
.
.
.
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.
.
.
.
.
5
ppm
Corn,
field,
forage
.
.
.
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.
.
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.
.
.
.
.
.
.
1.5
ppm
Corn,
sweet,
forage
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1.5
ppm
Corn,
pop,
forage
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1.5
ppm
Teosinte,
forage
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1.5
ppm
Millet,
pearl,
forage
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1.5
ppm
Millet,
pearl,
hay
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
ppm
Millet,
proso,
forage
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1.5
ppm
Millet,
proso,
hay
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
ppm
Millet,
proso,
straw
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
ppm
Sorghum,
forage,
forage
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1.5
ppm
Sorghum,
forage,
hay
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
ppm
Sorghum,
grain,
stover
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
ppm
Sorghum,
grain,
forage
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1.5
ppm
Page
4
of
28
Food
Commodities
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
0.02
ppm
Hazard
Assessment:
Spinosad
is
classified
as
Toxicity
Category
III
for
acute
oral
and
dermal
toxicity
and
Toxicity
Category
IV
for
acute
inhalation
toxicity,
primary
eye
irriatation,
and
primary
skin
irritation.
It
is
not
a
dermal
sensitizer.
No
dermal
toxicity
was
seen
at
the
limit
dose
in
a
21­
day
dermal
toxicity
study
in
rabbits.
For
subchronic
toxicity,
the
primary
effects
seen
in
the
mouse
were
increased
vacuolation
of
cells
of
the
lymphoid
organs,
liver,
kidney,
stomach,
female
reproductive
tract,
and
epididymis,
and
less
severely
in
the
heart,
lung,
pancreas,
adrenal
cortex,
bone
marrow,
tongue,
pituitary
gland,
and
anemia.
In
rats,
thyroid
follicle
epithelial
cell
vacuolation,
anemia,
multifocal
hepatocellular
granuloma,
cardiomyopathy
and
spleenic
histiocytosis
were
observed.
In
dogs,
microscopic
changes
in
a
variety
of
tissues,
anemia,
and
possible
liver
damage
were
seen.

Spinosad
is
not
a
neurotoxic
agent.
No
neurotoxic
effects
were
seen
at
the
limit
dose
in
an
acute
neurotoxicity
study
in
rats
and
at
doses
up
to
42.7
mg/
kg/
day
in
a
subchronic
neurotoxicity
study.
It
is
negative
for
mutagenicity
in
various
mutagenicity
assays.
It
is
negative
for
carcinogenicity
in
rats
and
mice.
In
a
chronic
feeding
study
in
dogs,
toxicity
signs
such
as
increases
in
serum
alanine
aminotransferase,
aspartate
aminotransferase,
and
triglycerides
levels,
and
the
presence
of
tissue
abnormalities,
including
vacuolated
cell
aggregations,
arteritis,
and
glandular
cell
vacuolation
(
parathyroid)
were
seen.
Vacuolation
of
thyroid
follicular
cells,
increased
absolute
and
relative
thyroid
weights
were
observed
in
a
chronic
oral
toxicity
study
in
rats.
In
mice,
rats
and
dogs,
the
liver,
kidney,
spleen,
heart,
thyroid,
and
bone
marrow
(
anemia)
appeared
to
be
the
target
organs.

No
developmental
effects
were
seen
in
the
rat
and
rabbit
developmental
toxicity
studies.
Decreased
litter
size
and
survival
was
observed
in
the
presence
of
maternal
toxicity
(
deaths)
at
the
highest
dose
tested
(
HDT)
in
a
2­
generation
reproduction
study
in
rats.
Maternal
and
offspring
toxicity
(
deaths)
were
equally
severe,
indicating
no
evidence
of
increased
susceptibility
in
the
2­
generation
reproduction
study
in
rats.

There
were
no
major
differences
in
the
bioavailability,
routes
or
rates
of
excretion
or
metabolism
following
a
single
low,
high
oral,
or
repeated
oral
doses
in
rats.
The
feces
were
the
major
route
of
excretion.
Approximately,
70­
80%
of
the
dose
was
absorbed
with
approximately
20%
of
the
dose
eliminated
unabsorbed
in
the
feces.
The
excreted
metabolites
were
the
glutathione
conjugates
of
the
parent
and
O­
demethylated
Factor
A.
Metabolites
in
the
tissues
were
the
N­
and
O­
demethylated
Factor
A.
Biliary
excretion
was
rapid.
Metabolites
in
the
bile
included
the
glutathione
conjugates
of
the
unchanged
form,
as
well
as
N­
and
O­
demethylated
forms
of
Factor
D.

Dose
Response:
The
HED
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
met
on
22­
January­
1998
(
TXR
No.
012500)
and
11­
July­
2002
(
TXR
No.
0050928)
to
select
endpoints
for
risk
assessment
and
to
evaluate
the
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
spinosad
(
evaluated
according
to
the
February
2002
OPP
10X
guidance
document).
HED's
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor
Committee
(
SFC)
met
on
29­
July­
2002
and
recommended
that
the
10x
safety
factor
to
account
for
enhanced
sensitivity
of
infants
and
children
be
reduced
to
1x
(
TXR
No.
0051038).
Based
on
toxicological
considerations
(
evaluated
by
FQPA
SFC)
and
the
residue
assumptions
used
in
the
dietary
and
residential
exposure
analyses
(
evaluated
by
the
risk
assessment
team),
the
risk
assessment
team
concluded
that
the
FQPA
Safety
Factor
should
be
reduced
to
1x
when
assessing
chronic
dietary
and
short­
term
incidental
oral
exposures.
Table
1
is
a
summary
the
endpoints
used
in
the
current
risk
assessment.
Page
5
of
28
Table
1.
Summary
of
Toxicological
Doses
used
in
the
Current
Risk
Assessment
acute
dietary
(
all
populations
subgroups)
no
endpoint
attributable
to
a
single
exposure
was
identified;
this
risk
assessment
is
not
required
chronic
dietary
NOAEL
=
2.7
mg/
kg/
day
chronic
RfD
and
cPAD
=
0.027
mg/
kg/
day
short­
term
incidental
oral
oral
NOAEL
=
4.9
mg/
kg/
day
level
of
concern
(
LOC)
for
margins
of
exposure
(
MOEs)
<
100
(
residential)

dermal
(
all
intervals)
dermal
risk
assessments
are
not
required
short­
term
inhalation
oral
NOAEL
=
4.9
mg/
kg/
day
LOC
for
MOEs
<
100
(
occupational)

intermediate­
term
inhalation
oral
NOAEL
=
2.7
mg/
kg/
day
LOC
for
MOEs
<
100
(
occupational)

cancer
(
oral,
dermal,
inhalation)
not
likely
to
be
carcinogen;
cancer
risk
assessments
are
not
required
Occupational
Exposure
and
Risk
Assessment:
No
chemical­
specific
data
are
available
with
which
to
assess
potential
exposure
to
pesticide
handlers.
Therefore,
pesticide
handler
exposures
were
calculated
based
upon
surrogate
study
data
available
in
the
Pesticide
Handler's
Exposure
Database
(
PHED;
v.
1.1,
1998).
For
pesticide
handlers,
it
is
HED
policy
to
present
estimates
of
exposure
for
"
baseline;"
that
is,
with
a
single
layer
of
work
clothing
consisting
of
a
long­
sleeved
shirt,
long
pants,
shoes
plus
socks,
and
no
protective
gloves
and
with
a
single
layer
of
work
clothing
and
the
use
of
protective
gloves
or
other
personal
protective
equipment
(
PPE)
as
might
be
necessary.
Since
the
HIARC
only
identified
inhalation
endpoints
(
no
dermal
endpoints
were
identified),
only
inhalation
exposure
assessments
were
conducted.
All
resulting
MOEs
for
handlers
were
>
100,
and
therefore
do
not
exceed
HED's
level
of
concern,
except
for
applicators
using
high­
pressure
hand­
wand
equipment
to
apply
GF­
120
NF
Naturalyte
 
Fruit
Fly
Bait
and
mixer/
loaders
using
open
loading
of
Entrust
 
(
wettable­
powder
(
WP))
in
support
of
aerial
operations.
MOEs
less
than
HED's
level
of
concern
can
be
calculated
provided
the
individuals
performing
these
tasks
wear
an
approved
organic­
vapor
filtering
respirator
(
fruit
fly
bait
application
using
high­
pressure
handwand
applicator)
or
an
approved
dust/
mist
filtering
respirator
(
mixer/
loader
in
support
of
aerial
application
of
the
WP).

Residential
and
Non­
Occupational
Exposure
and
Risk
Assessment:
Spinosad
is
currently
registered
for
use
on
turf
and
ornamentals
to
control
a
variety
of
worms,
moths,
flies,
beetles,
midges,
thrips,
leafminers
and
fire
ants.
Granular
(
homeowner)
and
emulsifiable
concentrate
(
EC;
commercial
applicators)
formulations
are
registered.
Since
no
dermal
endpoints
were
identified
and
based
on
the
granular
formulation
and
low
vapor
pressure
for
spinosad,
residential
handler/
applicator
and
postapplication
dermal/
inhalation
exposure
assessments
were
not
conducted.
HED
concluded
that
there
is
potential
toddler
short­
term
non­
dietary
oral
exposures
(
hand­
to­
mouth,
object­
to­
mouth,
ingestion
of
granulars,
and
soil
ingestion).
Since
HIARC
did
not
identify
an
acute
dietary
endpoint,
episodic
ingestion
of
granulars
was
not
assessed.
The
resulting
combined
short­
term
incidental
oral
MOEs
were
640
and
are
therefore
less
than
HED's
level
of
concern.
HED
concludes
that
all
other
registered/
proposed
application
scenarios
will
not
result
in
residential
exposures.

Dietary
(
food
and
water)
Exposure
and
Risk
Assessment:
Chronic
dietary
risk
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
­
Food
Consumption
Intake
Database
(
DEEM­
FCID
 
,
ver.
2.03;
acute
and
cancer
endpoints
were
not
identified)
which
incorporates
the
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII;
1994­
1996
and
1998).
The
chronic
dietary
analyses
assumed
average/
projected
percent
crop
treated
estimates,
projected
percent
head
treated
resulting
from
the
dermal
and
premise
treatments
to
ruminants,
average
field
trial
residues,
experimentally
determined
processing
factors,
and
anticipated
livestock
residues.
For
drinking
water,
the
chronic
analyses
assumed
the
modeled
tier
1
FIRST
chronic
surface
water
estimate
resulting
from
the
application
of
spinosad
to
turf
(
highest
registered/
proposed
rate).
The
resulting
exposure
estimates
were
#
96%
the
cPAD
and
are
therefore
less
than
HED's
level
of
concern
(
children
1­
2
years
old
were
the
most
highly
exposed
subpopulation).
Page
6
of
28
Aggregate
Exposure
and
Risk
Assessment:
In
general,
aggregate
exposures
are
calculated
by
summing
dietary
(
food
and
water)
and
residential
exposures
(
residential
or
other
non­
occupational
exposures).
Based
on
the
anticipated
residential
exposure
scenarios
and
since
acute
and
cancer
risk
assessments
are
not
required,
only
short­
term
(
residential,
food,
and
water)
and
chronic
(
food
and
water)
aggregate
exposure
assessments
were
conducted.
Since
the
dietary
analyses
incorporated
drinking
water
estimates,
calculation
of
drinking
water
levels
of
comparison
(
DWLOCs)
are
unnecessary
(
the
dietary
analyses
represent
exposure
from
food
and
water).
Aggregate
short­
term
(
food,
water,
and
residential)
exposures
resulted
in
MOEs
$
150
and
aggregate
chronic
(
food
and
water)
exposures
were
#
96%
the
cPAD;
therefore,
aggregate
exposure
to
spinsoad,
as
a
result
of
all
registered/
proposed
uses,
is
less
than
HED's
level
of
concern.

Recommendations
for
Tolerances/
Registration:
Separate
recommendations
are
written
for
the
fruit
fly
bait
and
foliar
agricultural
petitions.
The
labels
for
both
petitions
propose
a
4­
hour
restricted
reentry
interval
(
REI).
It
appears
that
spinosad
is
eligible
for
a
reduced
REI
as
described
in
the
Pesticide
Regulation
(
PR)
Notice
95­
3
(
7­
June­
1995).
Since
certain
legal
documents
are
required
from
the
registrant
and
it
is
RD's
purview
to
grant
REIs,
HED
defers
to
RD
on
the
issue
of
an
acceptable
REI
for
spinosad.

Fruit
Fly
Bait
(
IR­
4;
PP#
s
3E6780):
Provided
the
petitioner
submits
revised
Sections
B
and
F,
HED
concludes
that
the
toxicology,
residue
chemistry,
and
occupational/
residential
databases
support
a
conditional
registration
and
establishment
of
the
permanent
tolerance
listed
in
Table
2
for
the
combined
residues
of
spinosyn
A
and
D.
Unconditional
registration
may
be
established
upon
submission
of
a
28­
day
rat
inhalation
toxicity
study.

Summary
of
Deficiencies:

°
revised
Section
B
(
see
Section
7.1)
°
revised
Section
F
°
28­
day
inhalation
toxicity
study
in
rats
Table
2:
Recommended
Tolerances
Commodity
Recommended
Tolerance
(
ppm)

raw
agricultural
commodities
0.02
Foliar
Agricultural
Applications
(
IR­
4;
PP#
s
3E6699,
3E6782,
3E6802,
3E6804,
and
4E6811):
Provided
the
petitioner
submits
revised
Sections
B
and
F,
HED
concludes
that
the
toxicology,
residue
chemistry,
and
occupational/
residential
databases
support
a
conditional
registration
and
establishment
of
the
tolerances
listed
in
Table
3
for
the
combined
residues
of
spinosyn
A
and
D.
Unconditional
registration
upon
may
be
established
upon
submission
and
review
of
the
cattle
feeding
study,
alfalfa
and
grass
SC
and
WP
side­
by­
side
residue
data,
banana
residue
data,
and
a
28­
day
rat
inhalation
toxicity
study.

Summary
of
Deficiencies:

C
revised
Section
B
(
see
Sections
4.2
and
7.1)

C
revised
Section
F
°
alfalfa
(
n=
3;
forage
and
hay
samples
should
be
collected
)
and
grass
(
n=
3;
forage
and
hay
samples
Page
7
of
28
should
be
collected)
side­
by­
side
residue
data
comparing
the
SC
and
WP
spinosad
formulations
or
submits
a
rationale
as
to
why
these
data
are
unnecessary
°
banana
field
trial
in
region
3
(
n=
1)
°
cattle
feeding
study
conducted
with
dietary
burdens
of
10
ppm,
100
ppm,
and
500
ppm
°
28­
day
inhalation
toxicity
study
in
rats
Table
3:
Recommended
Tolerances
Commodity
Recommended
Tolerance
(
ppm)

banana
0.25
vegetable,
bulb,
group
3,
except
green
onion
0.10
onion,
green
2.0
spearmint,
tops
3.5
peppermint,
tops
3.5
animal
feed,
nongrass,
group
18,
forage
35
animal
feed,
nongrass,
group
18,
hay
30
peanut,
hay
11
alfalfa,
seed
0.15
alfalfa,
seed
screenings
2.0
grass,
forage,
fodder
and
hay,
group
17,
forage
10
grass,
forage,
fodder
and
hay,
group
17,
hay
5.0
amaranth,
grain,
stover
10
grain,
cereal,
group
16,
stover,
except
rice1
10
grain,
cereal,
group
16,
forage,
except
rice1
2.5
grain,
cereal,
group
16,
hay,
except
rice1
10
grain,
cereal,
group
16,
straw,
except
rice1
1.0
cattle,
meat
2.0
sheep,
meat
2.0
goat,
meat
2.0
horse,
meat
2.0
cattle,
fat
50
sheep,
fat
50
goat,
fat
50
horse,
fat
50
cattle,
meat
byproducts,
except
liver2
5.0
sheep,
meat
byproducts,
except
liver2
5.0
goat,
meat
byproducts,
except
liver2
5.0
horse,
meat
byproducts,
except
liver2
5.0
cattle,
liver
10
sheep,
liver
10
goat,
liver
10
horse,
liver
10
milk
7.0
milk,
fat
85
poultry,
meat
0.10
poultry,
meat
byproducts
0.10
poultry,
fat
1.3
egg
0.30
1
HED
notes
that
all
currently­
established
cereal
grain
forage,
fodder,
stover,
hay,
and
straw
tolerances
in
180.495(
a)
should
be
eliminated
in
favor
of
the
cereal
grain
forage,
stover,
hay,
and
straw
tolerances
listed
in
the
table
2
the
current
ruminant
meat
by
product
tolerances
of
8
ppm
are
based
on
residues
in
liver;
HED
is
recommending
that
separate
liver
tolerances
be
established
and
the
meat­
byproduct
tolerance
be
based
on
residues
in
kidney
Page
8
of
28
O
O
C
H
3
N
C
H
3
C
H
3
O
O
CH
3
OCH
3
OCH
3
O
CH
3
H
3
CH
2
C
O
O
H
H
H
H
H
3
CO
R
Spinosyn
A:
R
=
H
Spinosyn
D:
R
=
CH
3
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
Table
4.
Test
Compound
Nomenclature
Chemical
Structure
Common
name
Spinosad
Company
experimental
name
XDE­
105
IUPAC
name
Spinosyn
A:
(
2R,
3aS,
5aR,
5bS,
9S,
13S,
14R,
16aS,
16bR)­
2­(
6­
deoxy­
2,3,4­
tri­
O­
methyl­
"
a­
L­
mannopyranosyloxy)­
13­(
4­
dimethylamino­
2,3,4,6­
tetradeoxy­$
ß­
Derythropyranosyloxy
9­
ethyl­
2,3,3a,
5a,
5b,
6,7,9,10,11,12,13,14,15,16a,
16bhexadecahydro
14­
methyl­
1H­
8­
oxacyclododeca[
b]
as­
indacene­
7,15­
dione
Spinosyn
D:
(
2S,
3aR,
5aS,
5bS,
9S,
13S,
14R,
16aS,
16bR)­
2­(
6­
deoxy­
2,3,4­
tri­
O­
methyl­
"
a­
L­
mannopyranosyloxy)­
13­(
4­
dimethylamino­
2,3,4,6­
tetradeoxy­$
ß­
Derythropyranosyloxy
9­
ethyl­
2,3,3a,
5a,
5b,
6,7,9,10,11,12,13,14,15,16a,
16bhexadecahydro
4,14­
dimethyl­
1H­
8­
oxacyclododeca[
b]
as­
indacene­
7,15­
dione
CAS
name
Spinosyn
A:
2­[(
6­
deoxy­
2,3,4­
tri­
O­
methyl­"­
L­
manno­
pyranosyl)
oxy]­
13­[[
5­
(
dimethylamino)­
tetrahydro­
6­
methyl­
2H­
pyran­
2­
yl]
oxy]­
9­
ethyl­
2,3,3a,
5a,
5b,
6,9,10,11,12,13,14,16a,
16b­
tetradecahydro­
14­
methyl­
1H­
as­
Indaceno[
3,2­
d]
oxacyclododecin­
7,15­
dione
Spinosyn
D:
2­[(
6­
deoxy­
2,3,4­
tri­
O­
methyl­"­
L­
manno­
pyranosyl)
oxy]­
13­[[
5­
(
dimethylamino)­
tetrahydro­
6­
methyl­
2H­
pyran­
2­
yl]
oxy]­
9­
ethyl­
2,3,3a,
5a,
5b,
6,9,10,11,12,13,14,16a,
16b­
tetradecahydro­
4,14­
methyl­
1H­
as­
Indaceno[
3,2­
d]
oxacyclododecin­
7,15­
dione
CAS
#
Spinosyn
A:
131929­
60­
7
Spinosyn
D:
131929­
63­
0
Table
5.
Physicochemical
Properties
of
the
Technical
Grade
Test
Compound
Melting
point/
range
Spinosad
A:
84­
99.5
°
C
Spinosad
D:
161.5­
170
°
C
EPA
Fact
Sheet
pH
(
10%
slurry
of
spinosad
in
water)
7.74
Density
at
20
/

C
0.512
Water
solubility
(
ppm)
Spinosad
A:
89.4
Spinosad
D:
0.495
Vapor
pressure
at
25
/

C
(
kPa)
Spinosad
A:
3.0
x
10­
11
Spinosad
D:
2.0
x
10­
11
Dissociation
constant
(
pKa)
not
available
Octanol/
water
partition
coefficient
Log(
KOW)
pH
5
pH
7
pH
9
Spinosad
A
2.8
4.0
5.2
Spinosad
D
3.2
4.5
5.2
UV/
visible
absorption
spectrum
not
available
Page
9
of
28
3.0
HAZARD
CHARACTERIZATION
A
detailed
hazard
characterization
for
spinosad
is
presented
in
a
previous
HED
risk
assessment
(
D284803,
D.
Vogel
et
al.,
15­
Aug­
2002).
Please
refer
to
this
document
for
complete
information
concerning
the
hazard
characterization
of
spinosad.

The
HIARC
met
on
22­
January­
1998
(
TXR
No.
012500)
and
11­
July­
2002
(
TXR
No.
0050928)
to
select
endpoints
for
risk
assessment
and
to
evaluate
the
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
spinosad
(
evaluated
according
to
the
February
2002
OPP
10X
guidance
document).
The
FQPA
SFC
met
on
29­
July­
2002
and
recommended
that
the
10x
safety
factor
to
account
for
enhanced
sensitivity
of
infants
and
children
be
reduced
to
1x
(
TXR
No.
0051038).
Based
on
toxicological
considerations
(
evaluated
by
FQPA
SFC)
and
the
residue
assumptions
used
in
the
dietary
(
D319957,
T.
Bloem,
24­
Aug­
2005)
and
residential
(
D284802,
M.
Dow
and
D.
Vogel,
15­
Aug­
2002)
exposure
analyses
(
evaluated
by
the
risk
assessment
team),
it
was
concluded
that
the
FQPA
Safety
Factor
should
be
reduced
to
1x
when
assessing
chronic
dietary
and
short­
term
incidental
oral
exposures.
Table
6
is
a
summary
of
the
endpoints
used
in
the
current
assessment.

Table
6.
Summary
of
Toxicological
Doses
and
Toxicological
Endpoints
for
Spinosad
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
­
all
populations
No
endpoint
attributable
to
a
single
exposure
was
identified.
This
risk
assessment
is
not
required.

Chronic
Dietary
­
all
populations
NOAEL=
2.7
mg/
kg/
day
UF
=
100
cRfD
=
0.027
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
0.027
mg/
kg/
day
Chronic
Toxicity
Study
in
Dogs;
LOAEL
=
8.22
mg/
kg/
day;
based
on
vacuolation
in
glandular
cells
(
parathyroid)
and
lymphatic
tissues,
arteritis,
and
increases
in
serum
alanine
aminotransferase,
aspartate
aminotransferase,
and
triglycerides
levels
Short­
term
Incidental
Oral
(
1
­
30
Days)
NOAEL=
4.9
mg/
kg/
day
LOC
for
MOEs
<
100
Subchronic
Feeding
Study
in
Dogs;
LOAEL
=
9.73
mg/
kg/
day
based
on
microscopic
changes
in
multiple
organs,
clinical
signs
of
toxicity,
decreases
in
mean
body
weights
and
food
consumption
and
biochemical
evidence
of
anemia
and
possible
liver
damage
Dermal
(
Any
Time
Period)
Short­,
Intermediate­
and
Long­
Term
dermal
risk
assessments
are
not
required
for
the
following
reasons:
1)
lack
of
concern
for
pre
and/
or
post
natal
toxicity;
2)
the
combination
of
molecular
structure
and
size
as
well
as
the
lack
of
dermal
or
systemic
toxicity
at
1000
mg/
kg/
day
in
a
21­
day
dermal
toxicity
study
in
rats
which
indicates
poor
dermal
absorption;
and
3)
the
lack
of
long­
term
exposure
based
on
the
current
use
pattern.

Short­
term
Inhalation
(
1
­
30
days)
Oral
NOAEL=
4.9
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOEs
<
100
(
occupational)
Subchronic
Feeding
Study
in
Dogs;
LOAEL
=
9.73
mg/
kg/
day
based
on
microscopic
changes
in
a
multiple
organs,
clinical
signs
of
toxicity,
decreases
in
mean
body
weights
and
food
consumption
and
biochemical
evidence
of
anemia
and
possible
liver
damage
Intermediate­
term
Inhalation
(
1
­
6
Months)
Oral
NOAEL=
2.7
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOEs
<
100
(
occupational)
Chronic
Toxicity
Study
in
Dogs;
LOAEL
=
8.22
mg/
kg/
day;
based
on
vacuolation
in
glandular
cells
(
parathyroid)
and
lymphatic
tissues,
arteritis,
and
increases
in
serum
alanine
aminotransferase,
aspartate
aminotransferase,
and
triglycerides
levels
Cancer
Classification:
Not
likely
to
be
carcinogen;
cancer
risk
assessment
is
not
required
1
UF=
Uncertainty
Factor;
RfD=
Reference
Dose;
FQPA
SF
=
Food
Quality
Protection
Act
Safety
Factor;
PAD
=
Population
Adjusted
Dose=
RfD/
FQPA
SF;
LOC
=
level
of
concern;
MOE
=
margin
of
exposure
Page
10
of
28
3.1
Endocrine
Disruption
EPA
is
required
under
the
FFDCA,
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
recommendations
of
its
Endocrine
Disruptor
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
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).
In
the
available
spinosad
toxicity
studies,
there
was
no
estrogen
or
thyroid
mediated
toxicity.

4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
residue
chemistry
summary
(
foliar
agricultural
applications)
­
D312374,
T.
Bloem,
20­
Jul­
2005
residue
chemistry
summary
(
fruit
fly
bait)
­
D319956,
T.
Bloem,
10­
Aug­
2005
dietary
exposure
analysis
­
D319957,
T.
Bloem,
24­
Aug­
2005
residential
exposure
analysis
­
D284802,
M.
Dow
and
D.
Vogel,
15­
Aug­
2002
drinking
water
summary
­
EFED
memo;
D310860,
R.
Parker,
14­
Sep­
2005
4.1
Summary
of
Registered
Uses
Spinosad
is
currently­
registered
for
application
to
numerous
crops
with
tolerances
for
the
combined
residues
of
spinosyn
A
and
D
ranging
from
0.01­
200
ppm
(
40
CFR
180.495).
Spinosad
is
also
registered
for
homeowner
application
to
turf/
ornamentals.

4.2
Summary
of
Proposed
Uses
Fruit
Fly
Bait:
The
petitioner
is
requesting
registration
for
application
of
GF­
120
NF
Naturalyte
 
Fruit
Fly
Bait
(
0.002
lb
ai/
gallon;
EC;
EPA
Reg.
No.
62719­
498),
for
control
of
tephritid
fruit
flies,
to
any
tree,
nut,
vine,
vegetable,
or
food
crop.
Ground
(
directed
to
a
specific
plant
or
broadcast)
and
aerial
applications
are
specified
(
application
through
irrigation
equipment
is
prohibited).
For
aerial
and
most
other
applications,
the
formulated
product
is
to
be
mixed
with
water
at
a
ratio
of
1
part
formulated
product
to
1.5
parts
water
(
v:
v).
For
ground
applications
and
applications
in
low
relative
humidity,
the
product
is
to
be
mixed
with
water
at
a
ratio
of
1
part
formulated
product
to
5
parts
water
(
v:
v).
Ground
applications
are
to
be
directed
to
the
bottoms
of
leaves
and
leaves
inside
the
foliage
canopy
(
reduces
exposure
to
sun
and
rain).
The
label
states
that
large
droplets
sizes
are
necessary
to
obtain
optimum
control
of
insect
pests
(
4000­
6000
:
m)
and
recommends
spray
volumes
of
<
1
gallon/
acre
(
aerial
application
should
use
ultra
low
application
volumes
(
20­
80
droplets/
m2)).
Applications
are
to
begin
as
soon
as
monitoring
traps
indicate
flies
are
present
or
2­
3
weeks
before
fruit
ripens.
Repeat
applications
are
permitted
every
7­
14
days,
shortening
the
application
interval
during
rainy
periods
or
as
the
fruit
ripens.
The
label
does
not
specify
a
PHI.
The
residue
data
submitted
in
support
of
this
petition
was
conducted
with
a
0­
day
PHI;
therefore,
a
PHI
is
unnecessary.
Table
7
is
a
summary
of
the
proposed
application
scenarios.
HED
concludes
that
the
proposed
use
directions
are
adequate
and
supported
by
the
available
residue
data.
Page
11
of
28
HED
notes
that
the
label
prohibits
aerial
application
in
the
"
immediate
proximity
of
residential,
commercial,
government,
institutional
or
other
structures
where
people
may
be
present
including,
but
not
limited
to,
homes,
apartments,
offices,
churches,
schools,
and
businesses."
In
urban
areas,
use
is
limited
to
ground
applications.

Table
7.
Summary
of
Proposed
Application
Scenarios
Formulation
Site
Single
App.
Rate
(
lb
ai/
acre)
Seasonal
App.
Rate
(
lb
ai/
acre)
RTI
(
days)
Comments
GF­
120
NF
Naturalyte
®
Fruit
Fly
Bait
(
0.002
lb
ai/
gallon;
EC;
EPA
Reg.
No.
62719­
498)
any
tree,
nut,
vine,
vegetable,
or
food
crop;
ornamentals;
and
noncrop
vegetation
for
control
of
tephritid
fruit
flies
0.0003
not
specified
7­
14
S
aerial,
ground,
and
spot
applications
are
permitted
(
chemigation
is
prohibited)

S
when
applying
aerially,
ultra
low
application
volumes
should
be
used
(
20­
80
droplets/
m2)

S
for
all
application
methods,
the
label
specifies
spray
volumes
of
0.20­
0.94
gallons/
acre.

1
RTI
=
retreatment
interval
Foliar
Agricultural
Scenarios:
The
petitioner
is
requesting
registration
for
application
of
spinosad
to
the
bulb
vegetable
crop
group,
banana,
plantain,
legume
forage,
and
mint;
removal
of
the
feeding
restriction
for
peanut
hay;
foliar
application
to
the
grass
forage,
fodder,
and
hay
group;
and
reduction
in
the
forage
(
from
7­
14
days
to
3
days),
fodder
(
from
14­
28
days
to
3
days),
and/
or
hay
(
from
14­
28
days
to
3
days)
PHIs
for
sorghum,
milo,
pearl
millet,
proso
millet,
grain
amaranth,
teosinte,
corn
(
field,
sweet,
popcorn,
and
seed
corn),
and
small
grains
(
wheat,
barley,
rye,
oats,
and
triticale).
In
support
of
these
requests,
that
petitioner
provided
proposed
use
directions
for
the
following
labels:
Success
 
(
22.8%
suspension­
concentrate
(
SC),
2
lbs
ai/
gallon,
EPA
Reg.
No.
62719­
292);
SpinTor
2SC
 
(
22.8%
SC,
2
lbs
ai/
gallon,
EPA
Reg.
No.
62719­
294);
Conserve
 
(
0.015%
granular,
EPA
Reg.
No.
62719­
329);
Tracer
 
(
44.2%
SC,
4
lb
ai/
gallon,
EPA
Reg.
No.
62719­
267);
and/
or
Entrust
 
(
80%
WP).
Table
8
is
a
summary
of
the
proposed
application
scenarios.

HED
has
reviewed
the
proposed
use
directions
and
is
requesting
that
the
petitioner
submit
labels
which
incorporate
the
following
changes:

S
bulb
vegetable:
SpinTor
2SC
 
and
Success
 
labels
should
specify
a
minimum
RTI
of
4
days.

S
mint:
Success
 
label
should
specify
a
minimum
RTI
of
4
days.

S
teosinte:
SpinTor
2SC
 
label
should
specify
a
28­
day
PHI
for
grain
and
maximum
seasonal
application
rate
of
0.188
lb
ai/
acre.

S
legume
forage:
All
labels
should
indicate
a
0­
day
PHI
for
forage
and
indicate
that
hay
and
fodder
may
be
cut
3
days
after
application.
Entrust
 
,
Success
 
,
and
Tracer
 
labels
should
specify
"
legume
forage
grown
for
seed"
rather
than
"
legume
grown
for
seed."

S
grass
forage,
fodder,
and
hay
group:
All
labels
should
indicate
a
0­
day
PHI
for
forage
and
indicate
that
hay
and
fodder
may
be
cut
3
days
after
application.

S
small
grains:
The
Success
 
and
Entrust
 
labels
indicate
application
to
cereal
grains,
including
but
not
limited
to
barley,
buckwheat,
oats,
rye,
triticale,
and
wheat
is
permitted.
Since
some
cereal
grain
crops
are
not
currently
registered,
HED
request
that
the
petitioner
indicate
that
the
application
instructions
apply
to
only
barley,
buckwheat,
oats,
rye,
triticale,
and
wheat.
Page
12
of
28
Page
13
of
28
Table
8.
Summary
of
Proposed
Foliar
Agricultural
Application
Scenarios
Formulation
Applic.
Type
Max.
Single
App.
Rate
(
lb
ai/
acre)
Max.
Season
App.
Rate
(
lb
ai/
acre)
PHI
(
days)
Comments
bulb
vegetables1
­
2
lb
ai/
gal
SC
(
SpinTor
2SC
 
and
Success
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.047­
0.094
0.45
1
­­

banana
and
plantain1
­
2
lb
ai/
gal
SC
(
Success
 
)
ground
sprays
directed
to
the
fruit
bunches
0.125
lb
ai/
100
gallon
solution
applied
to
fruit
bunches
until
runoff
max.
of
4
applic
56
S
do
not
make
applications
less
than
7
days
apart
mint1
­
2
lb
ai/
gal
SC
(
Success
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.062­
0.156
0.45
7
­­

legume
forages
and
legumes
grown
for
seed1
­
2
lb
ai/
gal
SC
(
Success
 
)

­
4
lb
ai/
gal
SC
(
Tracer
 
)

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.031­
0.062
0.186
3
­
hay,
forage,
and
fodder
S
do
not
allow
cattle
to
graze
from
treated
field
until
spray
has
dried
S
do
not
apply
more
than
3x
in
a
21
day
period;
if
applied
3x
in
succession,
do
not
apply
for
21
days;
do
not
apply
more
than
6
treatments
in
a
season
­
0.015%
granular
(
Conserve
 
)
broadcast
foliar
sprays
with
ground
equipment
0.038­
0.075
every
two
months
during
the
warm
part
of
the
year;
if
reapp.
is
required
a
RTI
14
days
is
specified
not
indicated
S
distribute
as
evenly
as
possible
with
a
calibrated
rotary­
type
hand­
held,
PTO,
electric,
or
ground
driven
spreader
S
if
rain
occurs
within
12
hours
of
application;
retreatment
may
be
necessary
peanut2
­
2
lb
ai/
gal
SC
(
SpinTor
2SC
 
)

­
4
lb
ai/
gal
SC
(
Tracer
 
)

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
equipment
0.05­
0.10
Entrust
and
Tracer
­

0.28
SpinTor
2SC­
0.45
3
­
nut,
forage,
and
hay
S
do
not
allow
cattle
to
graze
from
treated
field
until
spray
has
dried
S
do
not
apply
more
than
3x
in
a
30
day
period;
if
applied
3x
in
succession,
do
not
apply
for
30
days
S
do
not
make
applications
less
than
7
days
apart
S
Entrust
and
Tracer
­
do
not
make
more
than
3
applications
per
year
S
SpinTor
2SC
­
do
not
make
more
than
5
applications
per
year
Table
8.
Summary
of
Proposed
Foliar
Agricultural
Application
Scenarios
Formulation
Applic.
Type
Max.
Single
App.
Rate
(
lb
ai/
acre)
Max.
Season
App.
Rate
(
lb
ai/
acre)
PHI
(
days)
Comments
Page
14
of
28
grass
forage,
fodder,
and
hay
group
and
grass
crops
grown
for
seed
(
rangeland
and
pastures)
3
­
2
lb
ai/
gal
SC
(
Success
 
)

­
4
lb
ai/
gal
SC
(
Tracer
 
)

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.031­
0.062
0.186
3
­
hay,
forage,
and
fodder
S
do
not
allow
cattle
to
graze
from
treated
crop
until
spray
has
dried
S
do
not
apply
more
than
3x
in
a
21­
day
period;
if
applied
3x
in
succession,
do
not
apply
for
21
days
S
do
not
make
more
than
6
applications
per
season
­
0.015%
granular
(
Conserve
 
)
broadcast
foliar
sprays
with
ground
equipment
0.038­
0.075
every
two
months
during
the
warm
part
of
the
year;
if
reapplication
is
required
a
RTI
14
days
is
specified
not
indicated
A.
distribute
as
evenly
as
possible
with
a
calibrated
rotary­
type
hand­
held,
PTO,
electric,
or
ground
driven
spreader
B.
if
rain
occurs
within
12
hours
of
application;
retreatment
may
be
necessary
field
corn4
­
2
lb
ai/
gal
SC
(
Success
 
)

­
4
lb
ai/
gal
SC
(
Tracer
 
)

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
and
by
chemigation
0.025­
0.100
0.188
28
­
grain
3­
fodder
and
forage
­­

sweet
corn,
popcorn,
and
corn
grown
for
seed5
­
2
lb
ai/
gal
SC
(
SpinTor
2SC
 
and
Success
 
)

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
and
by
chemigation
0.023­
0.100
0.45
1­
grain
3
­
forage
and
fodder
­­

­
4
lb
ai/
gal
SC
(
Tracer
 
;
seed
corn
and
popcorn
only)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
and
by
chemigation
0.031­
0.094
0.188
seed
corn;
1
­
grain
3
­
fodder
and
forage
popcorn;
28
­
grain
3
­
fodder
and
forage
­­

teosinte6
­
2
lb
ai/
gal
SC
(
SpinTor
2SC
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.023­
0.094
0.45
1
­
grain
3
­
forage
and
fodder
­­

­
2
lb
ai/
gal
SC
(
Success
 
)

­
4
lb
ai/
gal
SC
(
Tracer
 
)

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.025­
0.100
0.188
28
­
grain
3
­
fodder
and
forage
­­
Table
8.
Summary
of
Proposed
Foliar
Agricultural
Application
Scenarios
Formulation
Applic.
Type
Max.
Single
App.
Rate
(
lb
ai/
acre)
Max.
Season
App.
Rate
(
lb
ai/
acre)
PHI
(
days)
Comments
Page
15
of
28
sorghum,
milo,
pearl
millet,
proso
millet,
and
grain
amaranth7
­
4
lb
ai/
gal
SC
(
Tracer
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.047­
0.094
0.45
7
­
grain
3
­
forage
and
fodder
­­

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.047­
0.094
0.28
21
­
grain
3
­
forage,
fodder,

and
hay
S
do
not
allow
cattle
to
graze
until
the
spray
has
dried
small
grains
(
wheat,
barley,
rye,
oats,
and
triticale)
8
­
2
lb
ai/
gal
SC
(
Success
 
)

­
4
lb
ai/
gal
SC
(
Tracer
 
)

­
80%
WP
(
Entrust
 
)
broadcast
foliar
sprays
with
ground
or
aerial
equipment
0.025­
0.100
0.28
21
­
straw
and
grain
3
­
forage,
fodder,

and
hay
S
do
not
allow
cattle
to
graze
until
the
spray
has
dried
1
spinosad
is
not
currently
registered
for
application
to
bulb
vegetables,
banana,
plantain,
and
legume
forages
2
The
2
lb
ai/
gallon
SC
(
Success
 
,
SpinTor
2SC
 
,
and
Naturalyte
 
)
formulation
of
spinosad
has
been
approved
by
HED
for
application
to
peanut
but
with
a
restriction
against
feeding
peanut
hay
to
livestock
(
5
x
0.094
lb
ai/
acre;
7­
day
RTI;
3­
day
PHI;
D279380,
W.
Donovan,
28­
Jun­
2002).
The
petitioner
is
requesting
that
this
restriction
be
lifted
and
is
requesting
registration
for
application
of
the
4
lb
ai/
gallon
SC
(
Tracer
 
)
and
80%
WP
(
Entrust
 
)
formulations.
No
change
in
the
registered
application
rate
or
the
nut
PHI
are
proposed.

3
The
0.015%
granular
formulation
(
Entrust
 
)
is
currently
registered
for
application
to
the
grass
forage
fodder
and
hay
group
as
a
fire
ant
bait
(
mound
treatment
only).
The
petitioner
is
requesting
broadcast
application
of
the
0.015%
granular
formulation
and
is
requesting
registration
for
application
of
the
2
lb
ai/
gallon
SC
(
Success
 
)
,
4
lb
ai/
gallon
SC
(
Tracer
 
)
,
and
80%
WP
(
Entrust
 
)
formulations.

4
The
2
lb
ai/
gallon
SC
(
Success
 
)
,
4
lb
ai/
gallon
SC
(
Tracer
 
)
,
and
80%
WP
(
Entrust
 
)
formulations
of
spinosad
are
currently
registered
for
application
to
field
corn.
The
petitioner
is
proposing
a
3­
day
PHI
for
forage
(
currently
7
days)
and
fodder
(
currently
28
days).
No
change
in
the
application
rate
or
PHI
for
grain
are
proposed.

5
The
2
lb
ai/
gallon
SC
(
Success
 
and
SpinTor
2SC
 
)
,
4
lb
ai/
gallon
SC
(
Tracer
 
)
,
and
80%
WP
(
Entrust
 
)
formulations
of
spinosad
are
currently
registered
for
application
to
sweet
corn,
popcorn,
and
corn
grown
for
seed.
The
petitioner
is
proposing
a
3­
day
PHI
for
forage
(
currently
7
days)
and
fodder
(
currently
28
days).
No
change
in
the
application
rate
or
PHI
for
grain
are
proposed.

6
The
4
lb
ai/
gallon
(
Tracer
 
)
formulation
of
spinosad
is
currently
registered
for
application
to
teosinte.
The
petitioner
is
requesting
application
of
the
2
lb
ai/
gallon
(
Success
 
and
SpinTor
2SC
 
)
and
80%
WP
(
Entrust
 
)
formulations
and
is
requesting
a
3­
day
PHI
for
PHI
for
forage
(
currently
7
days)
and
fodder
(
currently
28
days).
Provided
the
petitioner
submits
a
revised
SpinTor
2SC
 
label
incoporating
the
changes
listed
above,
no
change
in
the
application
rate
or
PHI
for
grain
are
proposed.

7
The
4
lb
ai/
gallon
(
Tracer
 
)
formulation
of
spinosad
is
currently
registered
for
application
to
sorghum,
milo,
pearl
millet,
proso
millet,
and
grain
amaranth.
The
petitioner
is
requesting
registration
for
application
of
the
80%
WP
(
Entrust
 
)
formulation
and
a
3­
day
PHI
for
forage
(
currently
14
days)
and
fodder
(
currently
7
days).
No
change
in
the
application
rate
and
grain
PHI
are
proposed.

8
The
2
lb
ai/
gallon
SC
(
Success
 
),
4
lb
ai/
gallon
SC
(
Tracer
 
)
,
and
80%
WP
(
Entrust
 
)
formulations
of
spinosad
are
currently
registered
for
application
to
small
grains.
The
petitioner
is
proposing
a
3­
day
PHI
for
forage
(
currently
14
days)
and
hay
(
currently
14
days).
No
change
in
the
application
rate
or
PHI
for
grain
and
straw
are
proposed.
Page
16
of
28
4.3
Dietary
Exposure/
Risk
Pathway
Nature
of
the
Residue
­
Plants/
Livestock:
The
nature
of
the
residue
in
plants
and
livestock
is
adequately
understood
based
on
metabolism
studies
conducted
with
apples,
cabbage,
cotton,
tomatoes,
turnips,
ruminants,
and
poultry.
The
HED
Metabolism
Assessment
Review
Committee
(
MARC)
determined
that
the
residue
of
concern
in
plants
and
livestock,
for
risk
assessment
and
tolerance
enforcement
purposes,
are
spinosyns
A
and
D
(
D243816,
G.
Herndon,
3­
Mar­
1998).

For
plants,
residue
levels
of
spinosyns
A
and
D
declined
significantly
with
increasing
PHI
(
decreased
40­
89%
as
the
PHI
increased
from
0
to
3
days;
decreased
86%
to
nondetectable
as
the
PHI
increased
from
0
to
10­
48
days).
This
decline
was
accompanied
by
incremental
increases
in
nonextractable
and
polar
14C­
residues.
Extensive
fractionation
and
characterization
of
nonextractable
and
polar
14C­
residues
in
selected
crops
indicated
that
most
of
the
radioactivity
was
degraded
to
multicomponent
residues
of
low
molecular
weight
which
are
subsequently
incorporated
into
natural
plant
constituents
(
D228434,
S.
Willett,
23­
Jan­
1997;
D243816,
J.
Herndon,
3­
Mar­
1998).

Foliar
Application
Scenario:
Magnitude
of
the
Residue
­
Plants/
Livestock:

Plants:
The
petitioner
submitted
banana,
green
onion,
mint,
alfalfa,
clover,
and
grass
field
trial
studies
and
submitted
a
mint
processing
study
(
only
required
processing
study).
HED
has
previously
agreed
to
a
reduced
field
trial
data
requirement
for
banana;
mint;
bulb
vegetables;
nongrass
animal
feed
crop
group;
and
grass
forage,
fodder,
and
hay
crop
group
and
concluded
that
the
grass
forage
and
hay
residue
data
may
be
used
to
support
the
proposed
reduction
in
the
forage,
fodder,
and/
or
hay
PHIs
for
sorghum,
milo,
pearl
millet,
proso
millet,
grain
amaranth,
teosinte,
corn
(
field,
sweet,
popcorn,
and
seed
corn),
and
small
grains
(
wheat,
barley,
rye,
oats,
and
triticale;
D252416,
G.
Herndon,
23­
Feb­
1999).

HED
notes
that
the
petitioner
is
citing
SC
residue
data
to
support
either
the
registration
for
application
of
the
80%
WP
spinosad
formulation
(
legume
forage;
peanut;
grass
forage,
fodder,
and
hay
group;
teosinte;
sorghum;
milo;
pearl
millet;
proso
millet;
and
grain
amaranth)
or
reduction
in
the
forage,
fodder,
and/
or
hay
PHIs
on
a
currently­
registered
80%
WP
label
(
field
corn,
sweet
corn,
popcorn,
seed
corn,
wheat,
barley,
rye,
oats,
and
triticale).
HED
has
previously
reviewed
spinach,
tomato,
and
lettuce
side­
by­
side
spinosad
residue
data
conducted
with
the
SC
and
water­
dispersible
granular
(
WDG;
similar
to
WP)
formulations
(
6
x
0.045­
0.134
lb
ai/
acre;
0.45
lb
ai/
acre/
season;
RTI
2­
4
days;
PHI
1
and
3
days).
The
resulting
data
indicated
that
there
were
no
significant
difference
in
combined
spinosyn
A
and
D
residues
in
lettuce
and
tomato.
However,
the
WDG
formulation
resulted
in
higher
residues
of
spinosyn
A
and
D
in
spinach
(
D232203,
G.
Herndon,
2­
Mar­
1998).
Based
on
these
data
and
since
the
petitioner
is
citing
SC
residue
data
to
support
either
the
registration
of
the
80%
WP
formulation
or
reduction
in
the
forage,
fodder,
and
hay
PHIs
on
a
currently­
registered
80%
WP
label,
HED
requests
that
the
petitioner
submit
side­
by­
side
grass
(
n=
3;
forage
and
hay
samples
should
be
collected)
and
alfalfa
(
n=
3;
forage
and
hay
samples
should
be
collected)
residue
data
comparing
the
SC
and
WP
formulations.
If
these
data
indicate
that
residues
are
greater
following
application
of
the
WP
formulation,
then
additional
data
may
be
requested.
Alternately,
the
petitioner
can
provide
a
rationale
as
to
why
the
WP
formulation
will
not
result
in
higher
spinosyn
A
and
D
residues
in/
on
the
requested
crops
as
compared
to
the
SC
formulation
(
should
include
an
explanation
as
to
why
spinosyn
A
and
D
were
higher
in
spinach
following
application
of
the
WDG
as
compared
to
the
SC;
Chemistry
Science
Adivsory
Council
(
ChemSAC
minutes
23­
March­
2005).
Page
17
of
28
Provided
the
petitioner
agrees
to
make
the
label
changes
recommended
in
the
"
proposed
use"
section,
agrees
to
submit
alfalfa
(
n=
3;
forage
and
hay
samples
should
be
collected)
and
grass
(
n=
3;
forage
and
hay
samples
should
be
collected)
side­
by­
side
field
trial
data
comparing
the
SC
and
WP
formulations
or
submits
a
rationale
as
to
why
these
data
are
unnecessary
(
see
preceding
paragraph),
and
agrees
to
submit
a
banana
field
trial
(
region
3;
n=
1),
HED
concludes
that
the
currently­
available
data
support
the
establishment
of
the
plant
tolerances
listed
in
Table
3
for
the
combined
residues
of
spinosyn
A
and
D
(
a
revised
Section
F
is
requested).

Livestock:
Based
on
the
recommended/
established
plant
tolerances,
the
maximum
theoretical
dietary
burdens
(
MTDBs)
for
beef
cattle,
dairy
cattle,
hog,
and
poultry
are
89.2
ppm,
83.4
ppm,
41.2
ppm,
and
4.85
ppm,
respectively.
The
petitioner
has
previously
submitted
cattle
(
conducted
at
1
ppm,
3
ppm,
and
10
ppm)
and
poultry
(
conducted
at
0.1
ppm,
0.3
ppm,
1.0
ppm,
and
5.0
ppm)
feeding
studies.
Provided
the
petitioner
agrees
to
submit
a
cattle
feeding
study
conducted
at
10
ppm,
100
ppm,
and
500
ppm,
HED
concludes
that
the
livestock
tolerances
listed
in
Table
3
for
the
combined
residues
of
spinosyn
A
and
D
are
appropriate
(
a
revised
Section
F
is
requested).
HED
notes
that
if
as
part
of
a
future
petition
the
poultry
dietary
burden
increases,
then
a
new
poultry
feeding
study
may
be
requested.

Fruit
Fly
Bait:
Magnitude
of
the
Residue
­
Plants/
Livestock:

Plants:
The
petitioner
submitted
residue
data
from
single
mustard
green
(
Region
2),
cowpea
forage
(
Region
2),
spinach
(
Region
10),
and
snap
bean
forage
(
Region
10)
field
trials
conducted
in
2001.
The
field
trials
were
treated
with
spinosad
at
0.5x,
1.5x,
or
5x
the
proposed
rate
(
samples
were
collected
on
the
day
of
application).
Based
on
these
data,
the
primary
crop
metabolism
studies,
and
since
harvesting
on
the
day
of
application
is
unlikely,
HED
concludes
that
the
tolerance
listed
in
Table
2,
for
the
combined
residues
of
spinosyn
A
and
D,
is
appropriate
(
a
revised
Section
F
is
requested).

Livestock:
Based
on
livestock
dietary
burdens
and
livestock
tolerances
recommended
as
result
of
the
foliar
agricultural
application
scenario,
HED
concludes
that
the
fruit
fly
bait
application
scenario
will
not
have
a
significant
effect
on
the
livestock
dietary
burden
or
the
magnitude
of
residues
in
livestock
commodities.

Nature/
Magnitude
of
the
Residue
­
Rotational
Crops:
Based
on
the
results
of
a
confined
rotational
crop
study,
the
MARC
concluded
that
the
residues
of
concern
in
rotational
crops
are
spinosyn
A
and
D
(
D243816,
G.
Herndon,
3­
Mar­
1998;
field
rotational
crop
data
have
not
been
submitted).
The
confined
study
was
conducted
at
0.98
lb
ai/
acre
($
2.2x
the
proposed
rates)
and
indicated
that
residues
are
incorporated
into
the
general
carbon
pool.
Spinosyns
A
and
D
were
not
detected
in
the
rotated
crops
(
wheat,
lettuce,
and
radish;
plant­
back
intervals
(
PBIs)
of
30,
120,
and
365
days).
Since
the
confined
study
was
conducted
at
$
2.2x
the
maximum
proposed
rate
and
since
spinosyns
A
and
D
were
not
detected,
HED
concludes
that
no
rotational
crops
restrictions
are
required
for
the
currently­
proposed
crops.
Page
18
of
28
Analytical
Enforcement
Method
­
Plants:
Method
RES
94025
(
GRM
94.02;
cottonseed)
has
been
successfully
subjected
to
an
independent
laboratory
validation
(
ILV)
as
well
as
an
EPA
laboratory
validation.
It
has
been
forwarded
to
FDA
for
inclusion
in
the
Pesticide
Analytical
Manual
(
PAM)
Volume
II
(
G.
Herndon,
2­
Mar­
1998).
The
following
methods
have
also
been
submitted
to
the
FDA
for
inclusion
in
PAM
II:
GRM
95.17
(
leafy
vegetables);
GRM
96.09
(
citrus);
GRM
96.14
(
tree
nuts);
GRM
95.04
(
fruiting
vegetables);
GRM
94.02.
S1
(
cotton
gin
byproducts),
and
an
immunoassay
method
which
was
validated
on
17
different
crop
matrices
(
G.
Herndon,
18­
Feb­
1998).

Since
the
methods
used
to
analyze
the
field
trial
and
processed
samples
were
similar
to
the
methods
currently
available
for
tolerance
enforcement
and
since
adequate
validation
data
were
submitted
with
the
field
trial
and
processing
data,
HED
concludes
that
the
currently­
available
enforcement
methods
are
sufficient
to
enforce
the
tolerances
associated
with
the
current
petitions.

Analytical
Enforcement
Method
­
Livestock:
Adequate
livestock
methods
are
available
for
tolerance
enforcement.
Method
RES
94094
(
GRM
95.03)
is
a
high­
performance
liquid
chromatograph/
ultraviolet
(
HPLC/
UV)
method
suitable
for
determination
of
spinosad
residues
in
ruminant
commodities.
Method
GRM
95.03
has
undergone
successful
ILV
and
EPA
laboratory
validation,
and
has
been
forwarded
to
FDA
for
inclusion
in
PAM
Volume
II
(
G.
Herndon,
6­
Apr­
1999).
Method
GRM
95.15
is
another
HPLC/
UV
method
suitable
for
determination
of
spinosad
residues
in
poultry
commodities.
This
method
has
been
forwarded
to
FDA
for
inclusion
in
PAM
Volume
II
(
D249374,
M.
Doherty,
24­
Jun­
1999).
Finally,
Method
RES
95114,
an
immunoassay
method
for
determination
of
spinosad
residues
in
ruminant
commodities
underwent
a
successful
ILV
and
EPA
laboratory
validation
and
has
been
submitted
to
FDA
for
inclusion
in
PAM
Volume
II
(
G.
Herndon,
5­
Jan­
1999).

4.4
Water
Exposure
and
Risk
Pathway
The
following
is
a
summary
of
information
provided
by
EFED
(
Memo
­
Larry
Liu,
3­
Aug­
2002
and
D310860,
R.
Parker,
14­
Sep­
2005).

Environmental
Fate
Assessment:
Spinosad
and
its
degradates
are
not
very
persistent
and
are
relatively
immobile.
The
potential
for
residues
to
leach
to
groundwater
or
runoff
to
surface
water
is
very
low.
Slow
metabolic
degradation
was
observed
only
in
flooded
sediment
(
half­
lives
161 
250
days
in
the
laboratory,
>
25
days
outdoors).
Transformation
products
(
Factor
B
and
N­
demethyl
spinosad
Factor
D)
are
persistent
in
aerobic
soil
metabolism
studies
(
half­
lives
>
6
months)
and
are
relatively
immobile.

Spinosyn
A
and
D
degrade
in
aerobic
laboratory
soil
with
half­
lives
of
13
and
14
days,
respectively.
They
photodegrade
readily
in
sterile
water
(<
1
day
at
pH
7)
and
soil
(
about
10
days).
Based
on
McCall's
relative
mobility
comparison,
spinosyn
A
has
a
low
to
slight
mobility
in
sandy
soils
and
is
immobile
in
silt
loam
and
clay
loam
soils.
Although
no
mobility
data
have
been
provided
for
Factor
D,
it
is
180x
less
soluble
than
spinosyn
A;
therefore,
spinosyn
D
is
less
likely
to
leach
in
the
soil
or
runoff
to
surface
water.
Spinosad
is
not
volatile
(
vapor
pressures
(
25
°
C)
are
2.0­
3.0
x
10­
11
kPa).
CO
2
is
the
only
volatile
degradate.
In
terrestrial
field
dissipation
studies
on
bareground
plots,
the
estimated
halflife
of
spinosyn
A,
formulated
as
an
EC,
was
0.3­
0.5
days,
and
residues
accounted
for
3.1%
of
the
applied
in
the
runoff
but
did
not
leach.
When
spinosad
was
applied
directly
to
the
water
surface
in
outdoor
aquatic
microcosm
dissipation
studies,
total
spinosad
residues
in
the
water
had
an
observed
Page
19
of
28
half­
life
of
<
1
day.
Page
20
of
28
Spinosad
is
stable
to
hydrolysis
in
pH
5,
7,
and
9
buffer
solutions.
In
flooded
sediment,
spinosad
moves
readily
from
the
water
to
the
solid
phases.
Spinosad
degrades
slowly
in
anaerobic
sediment
with
half­
lives
of
161­
250
days.
Degradation
rates
in
aerobic
sediment
were
not
determined.
In
an
aquatic
microcosm
study,
spinosad
residues
in
the
sediment
peaked
at
8
days
and
had
an
observed
half­
life
of
>
25
days.

The
major
transformation
product
of
spinosyn
A
is
Factor
B
(
N­
demethylated
spinosyn
A).
The
major
transformation
product
of
spinosyn
D
is
N­
demethylated
spinosyn
D.
In
aerobic
soil
metabolism
laboratory
studies
using
the
parent,
both
transformation
products
accumulated
to
>
50%
of
the
applied
by
28
days
and
had
observed
half­
lives
of
>
6
months.
Factor
B
is
relatively
immobile;
no
information
is
available
on
the
mobility
of
N­
demethylated
spinosyn
D.
Neither
transformation
product
was
identified
in
terrestrial
field
dissipation
studies.

Ground
and
Surface
Water
Estimates:
The
HED
MARC
determined
that
the
residue
of
concern
in
water
is
spinosad
per
se
(
D243816,
G.
Herndon,
3­
Mar­
1998).
At
the
present
time,
there
are
no
surface
or
ground
water
spinosad
monitoring
data
available.
Since
the
maximum
single
and
seasonal
application
rates
for
the
proposed
crops
are
much
lower
than
the
currently
registered
turf
application
rate
(
highest
registered/
proposed
rate),
EFED
recommended
using
the
turf
estimated
environmental
concentrations
(
surface
water
(
peak)
­
25.227
ppb;
surface
water
(
chronic;
56­
day
average)
­
2.313
ppb;
ground
water
(
acute
and
chronic)
­
0.037
ppb).
These
estimates
were
generated
using
FIRST
(
surface
water;
tier
1)
and
SCIGROW
(
ground
water
screening
model)
models.
The
turf
surface
water
estimate
is
the
highest
water
value
for
all
of
the
proposed/
registered
spinosad
uses
and
was
therefore
assumed
when
assessing
exposure
to
spinosad
via
drinking
water.

4.5
Dietary­
Exposure
Analysis
Chronic
dietary
risk
assessments
were
conducted
using
the
DEEM­
FCID
 
(
ver.
2.03;
acute
and
cancer
endpoints
were
not
identified)
which
incorporates
the
food
consumption
data
from
the
USDA's
CSFII
(
1994­
1996
and
1998).
The
chronic
dietary
analyses
assumed
average/
projected
percent
crop
treated
estimates,
projected
percent
head
treated
resulting
from
the
dermal
and
premise
treatments
to
ruminants,
average
field
trial
residues,
experimentally­
determined
processing
factors,
and
anticipated
livestock
residues.
For
drinking
water,
the
chronic
analyses
assumed
the
modeled
tier
1
FIRST
chronic
surface
water
estimate
resulting
from
the
application
of
spinosad
to
turf
(
highest
registered/
proposed
rate).
The
resulting
exposure
estimates
were
#
96%
the
cPAD
and
are
therefore
less
than
HED's
level
of
concern.
Table
9
is
a
summary
of
the
chronic
dietary
risk
assessment.

Table
9:
Summary
of
Chronic
Dietary
Exposure
and
Risk
(
drinking
water
included)

Population
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.027
0.008175
30
All
Infants
(<
1
year
old)
0.009605
36
Children
1­
2
years
old
0.025784
96
Children
3­
5
years
old
0.019729
73
Children
6­
12
years
old
0.012591
47
Youth
13­
19
years
old
0.007547
28
Adults
20­
49
years
old
0.006312
23
Adults
50+
years
old
0.005524
20
Females
13­
49
years
old
0.006119
23
Page
21
of
28
4.6
Residential
Exposure
and
Risk
Pathway
Spinosad
is
currently
registered
for
use
on
turf
and
ornamentals
to
control
a
variety
of
worms,
moths,
flies,
beetles,
midges,
thrips,
leafminers
and
fire
ants.
Granular
(
homeowner)
and
EC
(
commercial
applicators)
formulations
are
registered.
Since
no
dermal
endpoints
were
identified
and
based
on
the
granular
formulation
and
low
vapor
pressure
for
spinosad,
residential
handler/
applicator
and
postapplication
dermal/
inhalation
exposure
assessments
were
not
conducted.
HED
concluded
that
there
is
a
potential
for
toddler
short­
term
non­
dietary
oral
exposures
(
hand­
to­
mouth,
object­
to­
mouth,
ingestion
of
granulars,
and
soil
ingestion).
Since
HIARC
did
not
identify
an
acute
dietary
endpoint,
episodic
ingestion
of
granulars
was
not
assessed.
The
resulting
combined
short­
term
incidental
oral
MOEs
were
640
and
are
therefore
less
than
HED's
level
of
concern
(.

HED
notes
that
proposed
fruit
fly
bait
application
scenario
permit's
application
to
non­
crop
vegetation
and
this
use
may
result
in
residential
exposures.
Based
on
the
application
rates
(
fruit
fly
bait
­
0.0003
lb
ai/
acre;
turf/
ornamental
­
0.41
lbs
ai/
acre),
HED
concludes
that
residential
exposure
resulting
from
the
fruit
fly
application
will
be
insignificant
when
compared
to
the
exposure
resulting
from
the
turf/
ornamental
application.
Therefore,
quantitative
analysis
of
the
residential
exposure
resulting
from
the
fruit
fly
bait
application
was
not
performed.
HED
concludes
that
all
other
registered/
proposed
application
scenarios
will
not
result
in
residential
exposures.

4.7
Non­
occupational
Off­
Target
Exposure
Spray
drift
is
always
a
potential
source
of
exposure
to
residents
nearby
to
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
potential
source
of
exposure
from
ground
application.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices,
State
Lead
Agencies
for
pesticide
regulation,
and
other
parties
to
develop
the
best
spray
drift
management
practices.
On
a
chemical
by
chemical
basis,
the
Agency
is
now
requiring
interim
mitigation
measures
for
aerial
applications
that
must
be
placed
on
product
labels/
labeling.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
a
membership
of
U.
S.
pesticide
registrants,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off­
target
drift
with
specific
products
with
significant
risks
associated
with
drift.
Page
22
of
28
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
In
general,
aggregate
exposures
are
calculated
by
summing
dietary
(
food
and
water)
and
residential
exposures
(
residential
or
other
non­
occupational
exposures).
Based
on
the
anticipated
residential
exposure
scenarios
and
since
acute
and
cancer
risk
assessments
are
not
required,
only
short­
term
(
residential,
food,
and
water)
and
chronic
(
food
and
water)
aggregate
exposure
assessments
were
conducted.
Since
the
dietary
analyses
incorporated
drinking
water
estimates,
calculation
of
DWLOCs
are
unnecessary
(
the
dietary
analyses
represent
exposure
from
food
and
water).
The
following
paragraphs
are
summaries
of
the
short­
term
and
chronic
aggregate
exposure
assessments.

Short­
Term
Aggregate
Risk
Assessment:
Currently,
only
short­
term
incidental
oral
exposures
to
toddlers
are
anticipated
from
the
registered
turf
and
ornamental
application.
This
incidential
oral
exposure
is
combined
with
chronic
dietary
(
food
and
water)
exposure
for
determination
of
aggregate
short­
term
exposure.
HED
uses
chronic
dietary
exposure
when
conducting
short­
term
aggregate
assessments
as
it
has
been
determined
that
this
will
more
accurately
reflect
exposure
from
food
over
the
HED
defined
short­
term
interval
(
1­
30
days)
than
will
acute
exposure.
Table
10
is
a
summary
of
the
short­
term
aggregate
exposures
and
risk
estimates.
Since
the
aggregate
MOEs
were
$
150,
shortterm
aggregate
exposure
to
spinosad
is
less
than
HED's
level
of
concern.

Table
10.
Short­
Term
Aggregate
Risk
and
DWLOC
Calculations.

Population
NOAEL
(
mg/
kg/
day)
Target
MOE
Chronic
Food
and
Water
Exposure
(
mg/
kg/
day)
Residential
Oral
Exposure1
(
mg/
kg/
day)
Aggregate
MOE
(
food,
water,
and
residential)
2
All
infants
(<
1
year
old)
4.9
100
0.009605
0.0076
280
Children
(
1­
2
years
old)
4.9
100
0.025784
0.0076
150
Children
(
3­
5
years
old)
4.9
100
0.019729
0.0076
180
Children
(
6­
12
years
old)
4.9
100
0.012591
0.0076
240
1
residential
exposure
=
sum
of
hand­
to­
mouth,
object­
to­
mouth,
and
soil
ingestion
residue
estimates;
see
D284802,
M.
Dow
and
D.
Vogel,
15­
Aug­
2002
2
Aggregate
MOE
=
NOAEL
÷
(
Chronic
Food
Exposure
+
Residential
Exposure)

Chronic
Aggregate
Risk
Assessment:
Since
there
are
no
registered/
proposed
uses
which
result
in
chronic
residential
exposures,
the
chronic
aggregate
exposure
assessment
is
concerned
only
with
exposure
from
food
and
water.
Since
the
dietary
exposure
analysis
included
drinking
water,
the
discussion
and
exposure
estimates
exposure
presented
in
Section
4.5
represent
aggregate
chronic
exposure.
Page
23
of
28
6.0
CUMULATIVE
RISK
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
for
spinosad
and
any
other
substances,
and
spinosad
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
spinosad
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA'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
OPP
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/.

7.0
OCCUPATIONAL
EXPOSURE
D313757,
M.
Dow,
2­
Mar­
2005
D315415,
M.
Dow,
26­
Apr­
2005
The
available
exposure
data
for
combined
mixer/
loader/
applicator
scenarios
are
limited
in
comparison
to
the
monitoring
of
these
two
activities
separately.
These
exposure
scenarios
are
outlined
in
the
PHED
Surrogate
Exposure
Guide
(
August
1998).
HED
has
adopted
a
methodology
to
present
the
exposure
and
risk
estimates
separately
for
the
job
functions
in
some
scenarios
and
to
present
them
as
combined
in
other
cases.
Most
exposure
scenarios
for
hand­
held
equipment
(
such
as
hand
wands,
backpack
sprayers,
and
push­
type
granular
spreaders)
are
assessed
as
a
combined
job
function.
With
these
types
of
hand
held
operations,
all
handling
activities
are
assumed
to
be
effected
by
the
same
individual.
The
available
monitoring
data
support
this
and
HED
presents
them
in
this
way.
Conversely,
for
equipment
types
such
as
fixed­
wing
aircraft,
groundboom
tractors,
or
air­
blast
sprayers,
the
applicator
exposures
are
assessed
and
presented
separately
from
those
of
the
mixers
and
loaders.
By
separating
the
two
job
functions,
HED
determines
the
most
appropriate
levels
of
PPE
for
each
aspect
of
the
job
without
requiring
an
applicator
to
wear
unnecessary
PPE
that
may
be
required
for
a
mixer/
loader
(
e.
g.,
chemical­
resistant
gloves
may
only
be
necessary
during
the
pouring
of
a
liquid
formulation).

Spinosad
is
classified
as
Toxicity
Category
III
for
acute
oral
and
dermal
toxicity,
Toxicity
Category
IV
for
acute
inhalation
toxicity,
and
Toxicity
Category
IV
for
primary
eye
and
primary
skin
irritation.
It
is
not
a
dermal
sensitizer.
The
HIARC
did
not
identify
dermal
toxicological
endpoints;
therefore,
dermal
exposure
assessments
are
unnecessary.
Page
24
of
28
7.1
Handler
Exposure
No
chemical­
specific
data
are
available
with
which
to
assess
potential
exposure
to
pesticide
handlers.
The
estimates
of
exposure
to
pesticide
handlers
are
based
upon
surrogate
study
data
available
in
the
PHED
(
v.
1.1,
1998).
For
pesticide
handlers,
it
is
HED
policy
to
present
estimates
of
exposure
for
"
baseline;"
that
is,
with
a
single
layer
of
work
clothing
consisting
of
a
long­
sleeved
shirt,
long
pants,
shoes
plus
socks
and
no
protective
gloves
and
with
a
single
layer
of
work
clothing
and
the
use
of
protective
gloves
or
other
PPE
as
might
be
necessary.
The
Entrust
 
,
Success
 
,
Tracer
 
,
and
GF­
120
Naturalyte
 
Fruit
Fly
Bait
labels
all
require
applicators
and
other
handlers
to
wear
long­
sleeved
shirt,
long
pants
and
shoes
plus
socks.
The
Justice
 
Fire
Ant
Bait
label
requires
applicators
and
other
handlers
to
wear
long­
sleeved
shirt,
long
pants,
shoes
plus
socks
and
waterproof
gloves
when
handling
for
uses
covered
under
the
worker
protection
standard
(
WPS).
Uses
covered
under
the
WPS
are
any
agricultural
uses
where
plants
are
grown
for
sale/
commerce.
For
uses
not
covered
under
the
WPS,
(
aesthetic
plantings,
plants/
crops
not
grown
for
commercial
sale),
the
PPE
required
is
short­
sleeved
shirt,
long
pants
and
shoes
plus
socks.
The
following
paragraphs
are
summaries
of
handler
exposure
resulting
from
application
of
spinosad
to
the
proposed
agricultural
crops
and
as
a
fruit
fly
bait.

Fruit
Fly
Bait:
Based
upon
the
proposed
label,
HED
believes
most
occupational
pesticide
handlers
(
i.
e.,
mixers,
loaders,
applicators)
will
probably
be
"
commercial"
handlers.
Private
(
i.
e.
grower)
handlers
are
also
likely
to
apply
the
material.
In
the
State
of
California's
efforts
to
control
various
fruit
flies,
the
most
highly­
exposed
occupational
handlers
are
most
likely
to
be
persons
employed
by
or
contracted
by
the
state
to
provide
area
wide
applications
as
are
determined
necessary
by
survey
trapping
of
the
flies.
HED
believes
the
most
highly­
exposed
handlers
are:
(
1)
mixer/
loaders
supporting
aerial
operations;
(
2)
aerial
applicator;
(
3)
applicator
using
open­
cab
airblast
machinery;
(
4)
applicator
using
open­
cab
ground
boom
machinery;
(
5)
ultra­
low
volume
ground
applications;
(
6)
applicator
using
high­
pressure
handwand
sprayer.

It
is
doubtless
that
other
methods
of
application
might
be
utilized
such
as
backpack
sprayer
for
spot
treatments
(
etc.).
Based
on
data
in
PHED,
HED
believes
exposures
and
risks
from
other
methods
of
application
will
be
lower
than
those
noted
above.
The
methods
list
above
involve
much
larger
volumes
of
material
to
be
handled
per
work
day
than
could
possibly
be
handled
with
smaller
sprayers
or
methods
of
delivery.

Typically,
private
(
i.
e.,
grower)
pesticide
handlers
are
expected
to
experience
short­
term
duration
exposures
(
1
­
30
days).
However,
"
commercial"
(
i.
e.,
state­
employed
or
contracted)
handlers
may
also
experience
intermediate­
term
duration
exposures
(
1
­
6
months).
The
fruit
fly
control
efforts
in
California
are
essentially
statewide.
Growing
seasons
for
the
myriad
of
crops
grown
in
California
are
spread
over
most
of
a
calendar
year.

The
Science
Advisory
Council
for
Exposure
(
ExpoSac)
Standard
Operating
Procedure
9.1
(
Revised
25
September
2001),
"
Standard
Values
for
Daily
Acres
Treated
in
Agriculture"
indicates
that
up
to
7,500
acres
per
day
may
be
treated
by
aerial
ULV
applications
and
that
up
to
3,000
acres
per
day
may
be
treated
with
ULV
ground
applications.
Airblast
machinery
is
believed
to
treat
a
maximum
of
40
acres
per
day,
ground
boom
machinery
to
treat
a
maximum
of
200
acres
per
day,
and
high­
pressure
handwand
sprayer
to
spray
a
maximum
of
1,000
gallons
of
spray
per
day.
As
a
Tier
I,
"
worst
case"
screening
level
assessment,
these
values
are
used
herein.
Table
11
is
a
summary
of
the
pesticidehandler
exposure
estimates.
All
inhalation
MOEs
are
greater
than
100,
and
therefore
do
not
exceed
HED's
level
of
concern,
except
Page
25
of
28
for
application
using
high­
pressure
hand­
wand
equipment
(
short­
term
MOE
=
49;
intermediate­
term
MOE
=
27).
Data
in
the
PHED
indicate
that
use
of
an
organic­
vapor
filtering
respirator
can
reduce
inhalation
exposure
by
90%.
Short­
and
intermediate­
term
inhalation
MOEs
for
applicators
using
high­
pressure
handwand
equipment
while
wearing
an
organic­
vapor
filtering
respirator
are
490
and
270,
respectively
(
less
than
HED's
level
of
concern).
Therefore,
HED
requests
that
a
revised
Section
B
be
submitted
which
requires
applicators
who
use
high­
pressure
hand­
wand
equipment
to
wear
an
approved
organic­
vapor
filtering
respirator.

HED
notes
that
the
unit
exposure
data
for
an
applicator
using
high­
pressure
hand­
wand
equipment
is
classified
as
"
low
confidence
data."
The
number
of
observations
is
rather
low
and
most
of
the
observations
were
from
a
study
of
an
indoor
application
to
poultry
houses.
It
is
very
likely
that
applications
out
of
doors
would
result
in
lesser
exposure
than
what
has
been
estimated.
However,
more
suitable
data
are
not
available
for
use
to
refine
the
estimates.
The
estimate
of
exposure
could
be
refined
upon
receipt
of
suitable
compound
specific
or
surrogate
data
that
demonstrate
otherwise.
Foliar
Application
to
Agricultural
Crops:
Based
upon
the
proposed
use
pattern,
HED
expects
commercial
and
private
(
i.
e.,
grower)
occupational
pesticide
handlers
(
mixers,
loaders,
applicators)
to
typically
be
exposed
to
short­
term
duration
exposures
(
1
­
30
days).
However,
the
ExpoSAC
maintains
that
it
is
possible
for
some
commercial
handlers
to
be
exposed
to
intermediate­
term
(
1
­
6
months)
exposures.
It
is
thought
that
commercial
handlers
may
move
from
farm
to
farm
or
area
to
area
and
continuously
apply
a
material
to
the
same
crop
over
a
widely
spread
geographic
area.
Therefore,
estimated
risks
are
presented
for
handlers
who
experience
short­
term
as
well
as
intermediate­
term
exposures.
Based
upon
the
proposed
use
pattern,
HED
believes
the
most
highlyexposed
occupational
pesticide
handlers
are
most
likely
to
be:
(
1)
mixer/
loader
using
open­
pour
of
liquid;
(
2)
mixer/
loader
using
open
loading
of
WP;
(
3)
mixer/
loader
using
open
loading
of
granular;
(
4)
applicator
using
open­
cab,
ground­
boom
equipment;
(
5)
pilot
(
aerial
applicator);
(
6)
applicator
using
high­
pressure
handwand;
(
7)
applicator
using
open­
cab,
granular
broadcast;
and
(
8)
mixer/
loader/
applicator
using
commercial
"
push"
type
rotary
spreader
to
apply
granules.
Using
a
conservative
approach,
mixer/
loaders
are
assumed
to
be
supporting
aerial
operations
(
i.
e.,
1,200
acres
treated
per
day).
Ground
application
operations
are
assumed
to
be
350
acres
per
day.
An
applicator
using
highpressure
handwand
equipment
is
assumed
to
apply
1,000
gallons
of
spray
per
day.
A
mixer/
loader/
applicator
is
assumed
to
treat
5
acres
per
day.
Table
11
is
a
summary
of
the
pesticidehandler
exposure
estimates.

All
inhalation
MOEs
are
greater
than
100,
and
therefore
do
not
exceed
HED's
level
of
concern,
except
for
mixer/
loaders
using
open
loading
of
WP
in
support
of
aerial
operations
(
short­
term
MOE
=
66;
intermediate­
term
MOE
=
36).
Data
in
the
PHED
indicate
that
use
of
a
dust/
mist
filtering
respirator
reduces
inhalation
exposure
by
80%.
Short­
and
intermediate­
term
inhalation
MOEs
for
mixer/
loaders
using
open
loading
of
WP
in
support
of
aerial
operations
while
wearing
a
dust/
mist
filtering
respirator
are
326
and
180,
respectively
(
less
than
HED's
level
of
concern).
Therefore,
HED
requests
that
a
revised
Section
B
be
submitted
for
the
Entrust
 
label
which
requires
mixer/
loaders
to
wear
an
approved
dust/
mist
filtering
respirator.

Table
11.
Estimated
Inhalation
Handler
Exposure
and
Risk
from
the
Proposed
Use
of
Spinosad
Inhalation
Unit
Exposure1
mg
ai/
lb
handled
Applic.
Rate2
Units
Treated3
Per
Day
Average
Daily
Dose4
(
mg
ai/
kg
bw/
day)
MOE5
Table
11.
Estimated
Inhalation
Handler
Exposure
and
Risk
from
the
Proposed
Use
of
Spinosad
Page
26
of
28
ST
IT
Fruit
Fly
Bait
Mixer/
Loader
­
Liquid
­
Open
Pour
­
Supporting
Aerial
Operation
Inhal
0.0012
HC
0.0345
lb
ai/
acre
7,500
A
Inhal
0.00444
1100
610
Aerial
Applicator
Inhal
0.000068
MC
0.0345
lb
ai/
acre
7,500
A
Inhal
0.000251
20,000
11,000
Applicator
­
Open
Cab
­
Airblast
Inhal
0.0045
HC
0.0345
lb
ai/
acre
40
A
Inhal
0.0000887
55,000
30,500
Applicator
­
Ground­
boom
­
Open
Cab
Inhal
0.00074
HC
0.0345
lb
ai/
acre
200
A
Inhal
0.0000729
67,000
37,000
Applicator
­
Truck­
mounted
ULV
Ground
­
(
Groundboom
­
Closed
Cab
Used
as
Surrogate)

Inhal
0.000043
0.0345
lb
ai/
acre
3000
A
Inhal
0.0000636
77,000
42,500
Applicator
­
High
Pressure
Hand­
wand6
Inhal
0.079
LC
0.221
lb
ai/
gallon
formulation
(
0.0345
lb
ai/
acre)
400
gallons
formulation/
day
(
88
lb
ai/
day)
Inhal
0.0993
49
27
Inhal
with
respirator
0.00797
Inhal
0.00993
493
272
Foliar
Agricultural
Application
Mixer/
Loader
­
Liquid
­
Open
Pour
­
Supporting
Aerial
Operation
Inhal
0.0012
HC
0.16
lb
ai/
acre
1,200
acres
Inhal
0.0033
1,500
800
Mixer/
Loader
­
WP
­
Open
Load
Inhal
0.0434
MC
0.1
lb
ai/
acre
1,200
acres
Inhal
0.074
66
36
Inhal
with
respirator
0.00877
Inhal
0.015
326
180
Mixer/
Loader
­
Granular
­
Open
Load
Inhal
0.0017
HC
0.00075
lb
ai/
acre
200
acres
Inhal
0.0000036
1.4
million
750,000
Applicator
­
Aerial
Inhal
0.000068
MC
0.16
lb
ai/
acre
1,200
acres
Inhal
0.00019
26,000
14,000
Applicator
­
Ground­
boom
­
Open
Cab
Inhal
0.00074
HC
0.16
lb
ai/
acre
200
acres
Inhal
0.00034
14,400
7,500
Applicator
­
Broadcast
Granular
­
Open
Cab
Inhal
0.0012
LC
0.00075
lb
ai/
acre
200
acres
Inhal
0.0000026
1.9
million
>
1
million
Mix/
Load/
Applicator
­
High
Pressure
Hand­
wand
Inhal
0.12
LC
0.125
lb
ai/
100
gallon
1,000
gal/
day
(
1.25
lb
ai/
day)
Inhal
0.00214
2,300
1,300
Mixer/
Loader/
Applicator
­
Open
Pour
Granular
­
("
Belly
grinder")

Inhal
0.0063
HC
0.00075
lb
ai/
acre
5.0
acres
Inhal
0.00000034
>
14
million
8
million
1
unit
exposures
are
taken
from
"
PHED
SURROGATE
EXPOSURE
GUIDE",
Estimates
of
Worker
Exposure
from
The
Pesticide
Handler
Exposure
Database
Version
1.1,
August
1998;
inhal.
=
inhalation;
units
=
mg
ai/
pound
of
active
ingredient
handled;
data
confidence:
LC
=
low
confidence,
MC
=
medium
confidence,
HC
=
high
confidence
2
applic.
rate.
=
taken
from
sections
A
&
B
(
proposed
labeling)
3
units
treated
are
taken
from
"
Standard
Values
for
Daily
Acres
Treated
in
Agriculture";
SOP
No.
9.1.
ExpoSAC;
Revised
5­
Jul­
2000
4
average
daily
dose
=
unit
exposure
x
applic.
Rate
x
units
treated
÷
body
weight
(
70
kg).
5
MOE
=
NOAEL
÷
ADD;
ST
=
short­
term
MOE;
IT
=
intermediate­
term
MOE
6
the
label
indicates
that
the
most
effective
dilution
for
aerial
and
most
other
applications
is
1:
1.5
(
GF­
120:
water);
to
mix
10
gallons
of
spray
solution,
4
gallons
of
GF­
120
would
be
mixed
with
6
gallons
of
water;
HED
assumes
an
applicator
using
a
high­
pressure
handwand
sprayer
will
apply
1,000
gallons
of
spray
per
day;
therefore,
400
gallons
of
GF­
120
would
be
mixed
with
600
gallons
of
water.
And
400
gallons
*
0.221
lb
ai/
gallon
=
88.4
lb
ai
handled
per
day
7
PHED
indicates
that
organic­
vapor
filtering
respirator
(
fruit
fly
bait
application
with
high­
pressure
handwand)
and
dust/
mist
filtering
respirator
(
application
of
WP
in
support
of
aerial
applications)
will
provide
90%
and
80%,
respectively,
reduction
in
inhalation
exposure
Page
27
of
28
7.2
Post­
Application
Worker
Exposure
There
is
potential
for
agricultural
workers
to
experience
post­
application
exposure
to
pesticides
during
the
course
of
typical
agricultural
activities
such
as
crop
scouting,
hand­
weeding,
thinning,
or
other
irrigation
activities.
However,
in
this
case
the
HIARC
did
not
identify
dermal
toxicological
endpoints
and
post­
application
inhalation
exposure
for
agricultural
workers
is
considered
negligible;
therefore,
a
post­
application
risk
assessments
are
not
necessary
for
the
proposed
application
scenarios.

7.3
Restricted
Entry
Interval
The
REI
on
the
proposed
labels
is
4
hours.
It
appears
that
spinosad
is
eligible
for
a
reduced
REI
as
described
in
the
Pesticide
Regulation
(
PR)
Notice
95­
3
(
7­
June­
1995).
Since
certain
legal
documents
are
required
from
the
registrant
and
it
is
RD's
purview
to
grant
REIs,
HED
defers
to
RD
on
the
issue
of
an
acceptable
REI
for
spinosad.

8.0
DEFICIENCIES
/
DATA
NEEDS
8.1
Toxicology
Fruit
Fly
Bait
and
Foliar
Agricultural
Application
°
28­
day
inhalation
toxicity
study
in
rats
8.2
Chemistry
Fruit
Fly
Bait
°
revised
Section
F
Foliar
Agricultural
Application
C
revised
Section
B
C
revised
Section
F
°
alfalfa
(
n=
3;
forage
and
hay
samples
should
be
collected
)
and
grass
(
n=
3;
forage
and
hay
samples
should
be
collected)
side­
by­
side
residue
data
comparing
the
SC
and
WP
spinosad
formulations
or
submits
a
rationale
as
to
why
these
data
are
unnecessary
°
banana
field
trial
in
region
3
(
n=
1)
°
cattle
feeding
study
conducted
with
dietary
burdens
of
10
ppm,
100
ppm,
and
500
ppm
8.3
Occupational/
Residential
Fruit
Fly
Bait
and
Foliar
Agricultural
Application
°
revised
Section
B
Attachment
1:
Chemical
Structures
RDI:
RAB1
Branch
(
7­
Sept­
2005)
T.
Bloem:
806R:
CM#
2:(
703)
605­
0217:
7590C
Page
28
of
28
O
O
C
H
3
N
C
H
3
C
H
3
O
O
CH
3
OCH
3
OCH
3
O
CH
3
H
3
CH
2
C
O
O
H
H
H
H
H
3
CO
R
Spinosyn
A:
R
=
H
Spinosyn
D:
R
=
CH
3
Rhamnose
portion
Macrolide
portion
Forosamine
portion
O
O
C
H
3
NH
C
H
3
O
O
CH
3
OCH
3
OCH
3
O
CH
3
H
3
CH
2
C
O
O
H
H
H
H
H
3
CO
CH
3
Attachment
1:
Chemical
Names
and
Structures
Common
Name
Chemical
Name
Structure
Spinosyn
A
(
Factor
A)

2­[(
6­
deoxy­
2,3,4­
tri­
O­
methyl­"­
L­
mannopyranosyl
oxy]­
13­[[
5­(
dimethylamino)­
tetrahydro­
6­
methyl­
2H­
pyran­
2­
yl]
oxy]­
9­
ethyl­
2,3,3a,
5a,
5b,
6,9,10,11,12,13,14,16a,
16btetradecahydro
14­
methyl­
1H­
as­
Indaceno[
3,2­
d]
oxacyclododecin­
7,15­
dione
Spinosyn
D
(
Factor
D)

2­[(
6­
deoxy­
2,3,4­
tri­
O­
methyl­"­
L­
mannopyranosyl
oxy]­
13­[[
5­(
dimethylamino)­
tetrahydro­
6­
methyl­
2H­
pyran­
2­
yl]
oxy]­
9­
ethyl­
2,3,3a,
5a,
5b,
6,9,10,11,12,13,14,16a,
16btetradecahydro
4,14­
methyl­
1H­
as­
Indaceno[
3,2­
d]
oxacyclododecin­
7,15­
dione
N­
Demethyl
Spinosyn
D
(
Factor
B
of
D)

2­[(
6­
deoxy­
2,3,4­
tri­
O­
methyl­"­
L­
mannopyranosyl
oxy]­
9­
ethyl­
2,3,3a,
5a,
5b,
6,9,­
10,11,12,13,14,16a,
16b­
tetradecahydro­
4,14­
dimethyl­
13­[[
tetrahydro­
6­
methyl­
5­(
methylamino)­
2H­
pyran­
2­
yl]
oxy]­
1H­
as­
Indaceno[
3,2­
d]
oxacyclododecin­
7,15­
dione
Spinosyn
J
sturcutue
was
not
provided
based
on
MS
analysis,
structure
is
similar
to
spinosyn
A
Spinosyn
L
and
Spinosyn
O
structure
was
not
provided
based
on
MS
analysis,
structure
is
similar
to
spinosyn
D
with
loss
of
methyl
from
the
rhamnose
sugar
structure
was
not
provided
based
on
MS
analysis,
structure
is
similar
to
spinosyn
D
with
loss
of
methyl
from
the
rhamnose
sugar
15­
pk4
and
15­
pk6
structure
was
not
provided
based
on
MS
analysis,
structure
is
similar
to
spinosyn
D
with
loss
of
methyl
from
the
forosamine
sugar
dimethylamino
group
and
loss
of
a
methyl
from
rhamnose
sugar
