Document ID: EPA-HQ-OPP-2005-0545-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-04-14T04:00Z

EPA
Registration
Division
contact:
George
T.
LaRocca
(
703)
305­
6100
5F6994
and
3E6593
Summary
of
Petitions
EPA
has
received
pesticide
petitions
(
5F6994
and
3E6593)
from
Syngenta
Crop
Protection,
Inc.,
410
Swing
Rd
Greensboro,
NC
27409
and
Interregional
Research
Project
#
4
(
IR­
4),
681
US
Highway
#
1
South,
North
Brunswick,
NJ
08902­
3390
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
a
tolerance
for
residues
of
lambda­
cyhalothrin,
(
S)­
alpha­
cyano­
3­
phenoxybenzyl­
(
Z)­(
1R,
3R)­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,
2­
dimethylcyclopropanecarboxylate
and
(
R)­
alpha­
cyano­
3­
phenoxybenzyl­(
Z)­(
1S,
3S)­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,
2­
dimethylcyclopropanecarboxylate
and
the
epimer
of
lambda­
cyhalothrin,
(
S)­
alpha­
cyano­
3­
phenoxybenzyl­(
Z)­(
1S,
3S)­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,
2­
dimethylcyclopropanecarboxylate
and
(
R)­
alpha­
cyano­
3­
phenoxybenzyl­
(
Z)­(
1R,
3R)­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,
2­
dimethylcyclopropanecarboxylate
in
or
on
the
raw
agricultural
commodity
crop
groupings
of
the
cucurbit
vegetables
crop
group
(
crop
group
9)
at
0.05
parts
per
million
(
ppm)
(
5F6994),
the
grass
forage,
fodder
and
hay
crop
group
(
crop
group
17)
at
9.0
ppm
(
5F6994),
the
tuberous
and
corm
vegetables
crop
subgroup
(
crop
subgroup
1­
C)
at
0.01
ppm
(
5F6994),
barley
grain
at
0.05
parts
per
million
(
ppm),
buckwheat
grain
at
0.05
parts
per
million
(
ppm),
oat
grain
at
0.05
parts
per
million
(
ppm),
rye
grain
at
0.05
parts
per
million
(
ppm),
barley
bran
at
0.2
ppm
ppm
(
3E6593),
oat
forage
at
2.0
ppm
(
3E6593),
rye
forage
at
2.0
ppm
(
3E6593),
barley
hay
at
2.0
ppm
(
3E6593),
oat
hay
at
2.0
parts
ppm
(
3E6593),
barley
straw
at
2.0
ppm
(
3E6593),
oat
straw
at
2.0
ppm
(
3E6593),
rye
straw
at
2.0
ppm
(
3E6593),
and
wild
rice
grain
at
1.0
ppm
(
3E6593).
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
the
residue
is
well
understood
in
crops.
Data
on
plant
metabolism
show
that
lambda­
cyhalothrin
is
metabolized
by
cleavage
of
the
ester
linkage
to
form
cyclopropane
carboxylic
acids
and
the
corresponding
phenoxybenzoic
acid
and/
or
3­
phenoxybenzyl
alcohol.

2.
Analytical
method.
An
adequate
analytical
method
(
gas
liquid
chromatography
with
an
electron
capture
detector)
is
available
for
enforcement
purposes.

3.
Magnitude
of
residues.
Crop
field
trial
residue
data
for
the
proposed
crops
show
that
the
proposed
tolerances
on
these
commodities
will
not
be
exceeded
when
lambda­
cyhalothrin
is
used
as
directed.
In
addition,
a
beef
fat
market
basket
survey
of
residues
of
lambda­
cyhalothrin
in
samples
collected
across
the
contiguous
United
States
over
an
8
week
period
in
the
fall
of
2002
was
conducted.
The
survey
demonstrated
that
only
trace
levels
of
total
cyhalothrin
residues
are
in
only
a
small
percentage
of
samples
available
to
the
public.

B.
Toxicological
Profile
Assessments
of
toxic
effects
caused
by
lambda­
cyhalothrin
and
its
epimer
are
discussed
in
Unit
III.
A.
and
Unit
III.
B.
of
the
Federal
Register
notices
dated
September
27,
2002
and
(
67
FR
60903
­
60907)
and
April
8th,
2004
(
69
FR
18482
­
18485).

C.
Aggregate
Exposure
1.
Dietary
Exposure.
Tier
III/
IV
acute
and
chronic
dietary
exposure
evaluations
were
made
for
lambda­
cyhalothrin
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCIDTM),
version
2.03
from
Exponent.
These
exposure
assessments
included
all
registered
uses
and
proposed
uses
on
pasture
grasses,
cucurbit
vegetables,
the
tuberous
and
corm
vegetables
subgroup
1­
C,
barley,
buckwheat,
oats,
rye
and
wild
rice.
These
dietary
risk
assessments
utilized
residue
data
from
field
trials
where
lambda­
cyhalothrin
was
applied
at
the
maximum
intended
use
rate
and
samples
were
harvested
at
the
minimum
pre­
harvest
interval
(
PHI)
to
obtain
maximum
residues.
The
following
empirically
derived
processing
and
cooking
factors
were
used
in
these
assessments:
apple
pomace
(
8.28X),
apple
sauce
(
0.04X),
apple
washing
(
0.95x),
apple
peeling
(
0.06x),
apple
cooking
(
0.08x),
canola
oil
(
2.17x),
canola
seed
meal
(
0.08x),
corn
grain
milled
by­
products
(
2.0x),
cottonseed
hulls
(
0.14x),
cottonseed
meal
(
0.09x),
cottonseed
oil
(
0.14x),
peanut
nutmeats
meal
(
1.0x),
peanut
nutmeats
oil
(
1.0x),
peaches
washing
(
0.61x),
peaches
peeling
(
0.03x),
peaches
cooking
(
0.03x),
plums
prunes
(
1.44x),
rice
grain
bran
(
0.22x),
rice
grain
brown
(
0.03x),
rice
grain
hulls
(
6.20x),
rice
grain
polished
(
milled)
0.006x,
sorghum
grain
aspirated
grain
fraction
(
7.08x),
soybean
seed
hulls
(
0.80x),
soybean
seed
meal
(
0.80x),
soybean
seed
oil
(
0.80x),
sugarcane
molasses
(
0.04x),
sunflower
seed
oil
(
0.71x),
tomato
catsup
(
0.28x),
tomato
juice
(
0.10x),
tomato
paste
(
0.41x),
tomato
puree
(
0.34x),
wheat
aspirated
grain
fraction
(
39.2x),
wheat
bran
(
4.0x),
wheat
flour
(
0.6x),
wheat
germ
(
1.4x),
and
wheat
grain
milled
by­
products
(
4.0x).
Residue
data
from
monitoring
studies
(
PDP
and
market
basket
surveys)
were
also
utilized
for
the
following
commodities:
beef
fat,
broccoli,
cherries,
corn
grain
syrup,
lettuce,
milk,
nectarines,
onions,
peaches,
pears
(
canned),
peas
(
canned),
bell
peppers,
sweet
corn
(
canned),
tomatoes
(
fresh),
and
tomatoes
(
canned).
Percent
of
crop
treated
values
were
obtained
from
Doane's
Marketing
Research,
Doane's
Specialty
Crop
Study,
or
for
proposed
crop
uses
were
estimated
based
upon
economic,
pest
pressures
and
competitive
products.
Secondary
residues
in
animal
commodities
were
estimated
based
on
theoretical
worst­
case
animal
diets
and
transfer
information
from
feeding
studies.
All
consumption
data
for
these
assessments
was
taken
from
the
USDA's
Continuing
Survey
of
Food
Intake
by
individuals
(
CSFII)
with
the
1994­
96
consumption
database
and
the
Supplemental
CSFII
children's
survey
(
1998)
consumption
database.

i.
Food
Acute
Risk.
The
acute
dietary
risk
assessment
was
performed
for
all
population
subgroups
with
an
acute
reference
dose
of
0.005
mg/
kg­
bw/
day
based
on
an
acute
no
observable
adverse
effect
level
(
NOAEL)
of
0.5
mg/
kg­
bw/
day
from
a
one
year
dog
study
and
an
uncertainly
factor
of
100X.
The
100X
safety
factor
includes
intra­
and
inter­
species
variations.
No
additional
FQPA
safety
factor
was
applied.
For
the
purpose
of
the
aggregate
risk
assessment,
the
exposure
value
was
expressed
in
terms
of
margin
of
exposure
(
MOE),
which
was
calculated
by
dividing
the
NOAEL
by
the
exposure
for
each
population
subgroup.
In
addition,
exposure
was
expressed
as
a
percent
of
the
acute
reference
dose
(%
aRfD).
Acute
exposure
to
the
most
sensitive
subpopulation
(
children
1
­
2
years
old)
resulted
in
a
MOE
of
293
(
34.0%
of
the
acute
RfD
of
0.005
mg/
kg­
bw/
day).
Since
the
benchmark
MOE
for
this
assessment
was
100
and
since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
acute
dietary
(
food)
exposure
to
residues
arising
from
the
current
and
proposed
uses
for
lambda­
cyhalothrin.

Chronic
Risk.
The
chronic
dietary
risk
assessment
was
performed
for
all
population
subgroups
with
a
chronic
reference
dose
of
0.001
mg/
kg­
bw/
day
based
on
a
chronic
oral
study
in
the
dog
with
a
NOAEL
of
0.1
mg/
kg­
bw/
day
and
an
uncertainly
factor
of
100X.
The
100­
fold
safety
factor
includes
intra­
and
interspecies
variations.
No
additional
FQPA
safety
factor
was
applied.
For
the
purpose
of
the
aggregate
risk
assessment,
the
exposure
values
were
expressed
in
terms
of
margin
of
exposure
(
MOE),
which
was
calculated
by
dividing
the
NOAEL
by
the
exposure
for
each
population
subgroup.
In
addition,
exposure
was
expressed
as
a
percent
of
the
reference
dose
(%
RfD).
Chronic
exposure
to
the
most
exposed
sub­
population
(
children
1
­
2
years
old)
resulted
in
a
MOE
of
760
(
13.2%
of
the
chronic
RfD
of
0.001
mg/
kg­
bw/
day).
Since
the
benchmark
MOE
for
this
assessment
was
100
and
since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
chronic
dietary
(
food
only)
exposure
to
residues
arising
from
the
current
and
proposed
uses
for
lambda­
cyhalothrin.

Cancer
Risk.
The
database
for
carcinogenicity
is
considered
complete,
and
no
additional
studies
are
required
at
this
time.
The
requirements
for
oncogenicity
studies
in
the
rat
and
the
mouse
with
lambda­
cyhalothrin
have
been
satisfied
by
a
combined
chronic/
oncogenicity
study
in
rats
and
an
oncogenicity
study
in
mice,
both
conducted
with
lambda­
cyhalothrin.
Lambda­
cyhalothrin
has
been
classified
as
a
Group
D
chemical
(
not
classifiable
as
to
human
carcinogenicity)
with
regards
to
its
carcinogenic
potential.
Therefore,
no
cancer
risk
assessment
was
performed
for
lambda­
cyhalothrin.

ii.
Drinking
Water:
The
EPA
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCI­
GROW
to
predict
pesticide
concentrations
in
ground
water.
None
of
these
models
include
the
impact
of
processing
raw
water
(
mixing,
dilution,
or
treatment)
prior
to
distribution
as
drinking
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
conservative
approximation
of
the
estimated
environmental
concentration
of
specific
pesticides
in
drinking
water.
The
compounds
to
be
regulated
in
drinking
water
are
lambda­
cyhalothrin
and
the
4­
hydroxy­
degradate
(
parent
hydroxylated
in
the
4­
position
of
the
phenoxy
ring).
Since
monitoring
data
for
lambda­
cyhalothrin
and
the
4­
hydroxy­
degradate
were
not
available,
estimated
drinking
water
concentrations
(
EDWCs)
were
provided
by
EFED
(
MARC
Decision
Memo
for
4/
17/
02
Meeting
on
Lambda­
Cyhalothrin:
Residues
of
Concern
in
Drinking
Water)
based
on
sweet
corn
uses.
Based
on
Tier
II
(
PRZM/
EXAMS)
modeling
for
the
parent
compound
and
Tier
I
(
FIRST)
modeling
for
the
4­
hydroxy­
degradate,
the
surface
water
EDWCs
were
0.62
ppb
(
0.51
ppb
lambda­
cyhalothrin
and
0.11
ppb
4­
hydroxy­
degradate)
for
acute
exposures
and
0.098
ppb
(
0.09
ppb
lambda­
cyhalothrin
and
0.008
ppb
4­
hydroxy­
degradate)
for
chronic
exposures.
Based
on
SCI­
GROW
modeling,
the
ground
water
EDWCs
were
0.012
ppb
(
0.006
ppb
lambda­
cyhalothrin
and
0.006
ppb
4­
hydroxy­
degradate)
for
acute
exposures
and
0.012
ppb
(
0.006
ppb
lambda­
cyhalothrin
and
0.006
ppb
4­
hydroxy­
degradate)
for
chronic
exposures.
Since
the
surface
water
EDWCs
exceeded
the
ground
water
EDWCs,
the
surface
water
values
were
used
for
comparison
to
the
acute
Drinking
Water
Levels
of
Comparison
(
DWLOC)
and
will
be
considered
protective
for
any
ground
water
concentration
concerns.

Acute
Exposure
from
Drinking
Water.
The
acute
DWLOC
was
calculated
based
on
an
acute
Population
Adjusted
Dose
(
aPAD)
of
0.005
mg/
kg­
bw/
day.
The
calculated
DWLOC
for
the
most
sensitive
population
subgroup
(
children,
1
­
2
years)
was
33
ppb.
Since
the
acute
DWLOC
of
33
ppb
is
higher
than
the
acute
EDWC
of
0.62
ppb,
the
EPA
should
not
have
a
concern
for
acute
risk
from
either
surface
or
ground
water
from
current
and
proposed
uses
of
lambda­
cyhalothrin.

Chronic
Exposure
from
Drinking
Water.
The
chronic
water
exposure
was
obtained
from
the
DEEM­
FCID
 
software
based
on
an
input
of
the
chronic
surface
water
EDWC
of
0.098
ppb
for
water,
direct
and
indirect,
all
sources.
Chronic
water
exposure
to
the
U.
S.
population
resulted
in
a
MOE
of
48,412
(
0.2%
of
the
chronic
RfD
of
0.001
mg/
kg­
bw/
day).
The
most
exposed
sub­
population
was
infants
(<
1
year)
with
a
MOE
of
14,766
(
0.7%
of
the
chronic
RfD
of
0.001
mg/
kg­
bw/
day).
The
next
most
exposed
sub­
population
was
children
(
1
­
2
years)
with
a
MOE
of
32,601
(
0.3%
of
the
chronic
RfD
of
0.001
mg/
kg­
bw/
day).
Based
on
these
results,
there
is
no
concern
for
chronic
risk
from
either
surface
or
ground
water
from
current
and
proposed
uses
of
lambda­
cyhalothrin.

2.
Non­
Dietary
Exposure:
A
residential
exposure
and
risk
assessment
was
performed
for
a
lambda­
cyhalothrin
granular
lawn
product
applied
by
consumers.
Two
sets
of
residential
assessments
were
conducted
by
Syngenta,
one
for
an
adult
(
handler
and
re­
entry)
and
one
for
children
(
re­
entry
only).
The
application
rate
was
based
on
4
lb
product
per
1,000
sq
ft
(
0.078
lb
a.
i./
A)
applied
as
a
dry
granule
to
turf
using
a
consumer
push
rotary
spreader.
The
product
would
be
formulated
as
a
0.045%
active
on
a
dry
granule.
It
was
assumed
that
a
maximum
of
six
applications
could
be
made
per
year
for
a
total
annual
rate
of
0.47
lb
a.
i./
A.
NOAELs
of
10
mg/
kg/
day,
0.08
mg/
kg/
day
and
0.1
mg/
kg/
day
were
selected
for
assessing
the
risk
from
short­
term
dermal,
short­
term
inhalation
and
short­
term
oral
exposures,
respectively.
For
the
lawn
application
scenario,
the
short­
term
MOE
for
adults
(
U.
S.
Population)
was
calculated
as
19,822
based
on
dermal
and
inhalation
exposure.
For
the
re­
entry
scenario,
the
short­
term
MOE
for
adults
(
U.
S.
Population)
was
calculated
as
9,000
based
on
dermal
exposure
only.
The
combined
(
lawn
application
and
re­
entry)
short­
term
MOE
for
adults
(
U.
S.
Population)
was
6,197.
For
post­
application
exposures
to
treated
lawns,
the
combined
short­
term
MOE
for
children
was
149
based
on
dermal
and
non­
dietary
oral
exposure.
Since
the
EPA's
benchmark
MOE
for
lambda­
cyhalothrin
is
100,
the
residential
exposures
for
both
adults
and
toddlers
do
not
exceed
EPA's
level
of
concern.

D.
Cumulative
Effects
Cumulative
Exposure
to
Substances
with
a
Common
Mechanism
of
Toxicity.
Section
408(
b)(
2)(
D)(
v)
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".
The
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
lambda­
cyhalothrin
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
For
the
purposes
of
this
tolerance
action,
the
EPA
has
not
assumed
that
lambda­
cyhalothrin
has
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
1.
U.
S.
Population.
The
acute
aggregate
exposure
(
food
and
water)
from
all
established
and
proposed
lambda­
cyhalothrin
uses
resulted
in
a
MOE
of
502
for
the
U.
S.
population,
which
exceeds
the
benchmark
MOE
of
100.
The
chronic
aggregate
exposure
analysis
(
food
and
water)
showed
that
exposure
from
all
established
and
proposed
lambda­
cyhalothrin
uses
resulted
in
a
MOE
of
1,367
for
the
U.
S.
population.
A
short­
term
aggregate
exposure
analysis
(
food,
water
and
residential)
was
required
for
adults
because
there
are
residential
handler
(
dermal
and
inhalation)
and
re­
entry
(
dermal
only)
exposure
scenarios.
The
corresponding
MOEs
were
aggregated
using
the
inverse
MOE
approach.
For
short­
term
exposures,
the
chronic
dietary
(
food
and
water)
exposure
(
MOE
1,367)
was
aggregated
with
the
residential
exposure
(
MOE
6,197)
resulting
in
a
short­
term
aggregate
MOE
of
1,120
for
the
U.
S.
population.
An
intermediate­
term
aggregate
exposure
analysis
(
food
and
water
and
residential)
was
not
required
for
adults
because
residential
lawn
applications
scenarios
are
not
expected
to
occur
for
longer
than
a
short­
term
time
frame.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
supporting
these
petitions,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
residues
arising
from
all
current
and
proposed
lambda­
cyhalothrin
uses,
including
anticipated
dietary
exposure
from
food,
water,
and
all
other
types
of
non­
occupational
exposures.

2.
Infants
and
children.
The
acute
aggregate
exposure
(
food
and
water)
from
all
established
and
proposed
lambda­
cyhalothrin
uses
resulted
in
a
MOE
of
283
for
the
most
sensitive
population
subgroup
(
children,
1
­
2
years
old).
The
chronic
aggregate
exposure
analysis
(
food
and
water)
showed
that
exposure
from
all
established
and
proposed
lambda­
cyhalothrin
uses
resulted
in
a
MOE
of
743
for
this
same
population
subgroup.
A
short­
term
aggregate
exposure
analysis
(
food,
water
and
residential)
was
required
for
toddlers
because
there
are
residential
post­
application
dermal
and
oral
exposure
scenarios.
The
corresponding
MOEs
were
aggregated
using
the
inverse
MOE
approach.
For
short­
term
exposures,
the
chronic
dietary
(
food
and
water)
exposure
(
MOE
743)
was
aggregated
with
the
residential
exposure
(
MOE
149)
resulting
in
a
short­
term
aggregate
MOE
of
124
for
children,
1
­
2
years
old.
An
intermediate­
term
aggregate
exposure
analysis
(
food
and
water
and
residential)
was
not
required
for
children
because
residential
lawn
applications
scenarios
are
not
expected
to
occur
for
longer
than
a
short­
term
time
frame.
Since
the
worst­
case
aggregate
MOE
of
124
(
short­
term
risk)
exceeds
the
benchmark
MOE
of
100,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
occur
to
infants
and
children
from
aggregate
exposure
to
residues
arising
from
all
current
and
proposed
lambda­
cyhalothrin
uses,
including
anticipated
dietary
exposure
from
food,
water
and
all
other
types
of
non­
occupational
exposures.

F.
International
Tolerances
There
are
no
Codex,
Canadian,
or
Mexican
MRLs
established
for
residues
of
lambda­
cyhalothrin
in
plant
or
animal
commodities.
Codex
MRLs
for
cyhalothrin
are
established
for
several
commodities
which
are
unrelated
to
this
action.
Therefore,
a
discussion
of
compatibility
with
U.
S.
tolerances
is
not
relevant
at
this
time.