    
0
  
71
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
06­
APR­
2006
MEMORANDUM
SUBJECT:
Cypermethrin:
Phase
4
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED).
PC
Code
109702;
DP
Barcode
D293416.

From:
William
H.
Donovan,
Ph.
D.,
Chemist
Pamela
M.
Hurley,
Ph.
D.,
Toxicologist
John
Doherty,
Ph.
D.,
Toxicologist
Seyed
Tadayon,
Chemist
Reregistration
Branch
3
Health
Effects
Division
[
7509C]

Through:
Danette
Drew,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
[
7509C]

To:
Veronique
LaCapra,
Chemical
Review
Manager
Yan
Donovan,
Chemical
Review
Manager
Reregistration
Branch
2
Special
Review
and
Reregistration
Division
[
7508C]

Attached
is
the
Phase
4
risk
assessment
for
the
cypermethrin
Reregistration
Eligibility
Decision
(
RED).
This
is
a
revised
risk
assessment
incorporating
Phase
3
comments.
A
significant
change
from
the
previous
risk
assessment
involves
inclusion
of
the
results
from
review
of
the
developmental
neurotoxicity
(
DNT)
study
for
zeta­
cypermethrin,
which
resulted
in
reducing
the
10x
database
uncertainty
factor
to
1X.
The
disciplinary
science
chapters
and
other
supporting
documents
are
included
as
appendices
as
follows:
    
1
  
71
Cypermethrin/
Zeta­
cypermethrin
­
Report
of
the
Hazard
Identification
Assessment
Review
Committee
(
TXR
No.
0051578,
P.
Hurley,
2/
19/
03).

Cypermethrin/
Zeta­
cypermethrin
­
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
Document
(
TXR
No.
0052016,
P.
M.
Hurley,
7/
11/
2003).

Cypermethrin/
Zeta­
cypermethrin
­
HED
Chemistry
Chapter
of
the
RED:
Summary
of
Product
and
Residue
Chemistry
Residue
Data
(
D289422,
W.
H.
Donovan,
9/
25/
2003).

Cypermethrin/
Zeta­
cypermethrin
­
Phase
2
Acute
(
Probabilistic)
and
Chronic
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
(
D293419,
W.
H.
Donovan,
11/
16/
2005).

Cypermethrin
and
Zeta­
Cypermethrin:
Revised
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document
(
D293417,
S.
Tadayon,
4/
5/
2006).

Tier
II
Estimated
Environmental
Concentrations
of
Cypermethrin
for
use
in
the
Human
Health
Risk
Assessment
(
D289428,
J.
L.
Melendez,
5/
2/
2005).

Cypermethrin/
Zeta­
cypermethrin
­
Conclusions
of
the
Meeting
of
the
Metabolism
Assessment
Review
Committee
(
D269584,
Y.
Donovan,
11/
3/
2000).

The
risk
assessment,
the
residue
chemistry
data
review,
and
the
dietary
risk
assessment
were
provided
by
William
Donovan
(
RRB3),
the
hazard
characterization
by
Pamela
Hurley
and
John
Doherty
(
RRB3),
the
occupational/
residential
exposure
assessment
by
Seyed
Tadayon
(
RRB3),
and
the
drinking
water
assessment
by
Jose
Melendez
of
the
Environmental
Fate
and
Effects
Division
(
EFED).
    
2
  
71
1.0
EXECUTIVE
SUMMARY............................................................................................................
4
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION...........................................................
12
3.0
HAZARD
CHARACTERIZATION................................................................................................
13
3.1
Hazard
Profile..........................................................................................................
13
3.2
FQPA
Considerations
..............................................................................................
21
3.3
Dose­
Response
Assessment
.....................................................................................
22
3.4
Endocrine
Disruption...............................................................................................
26
4.0
EXPOSURE
ASSESSMENT.......................................................................................................
27
4.1
Summary
of
Registered
Uses
...................................................................................
27
4.2
Dietary
Exposure/
Risk
Pathway...............................................................................
30
4.2.1
Residue
Profile
..........................................................................................
30
4.2.2
Acute
Dietary............................................................................................
33
4.2.3
Chronic
Dietary.........................................................................................
34
4.2.4
Cancer
Dietary
..........................................................................................
35
4.3
Water
Exposure/
Risk
Pathway.................................................................................
35
4.4
Residential
Exposure/
Risk
Pathway..........................................................................
36
4.5
Spray
Drift...............................................................................................................
43
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
............................................
44
5.1
Acute
Aggregate
Risk..............................................................................................
44
5.2
Short­
Term
Aggregate
Risk.....................................................................................
46
5.3
Chronic
Aggregate
Risk...........................................................................................
48
5.4
Cancer
Risk
.............................................................................................................
49
6.0
CUMULATIVE
RISK................................................................................................................
49
7.0
OCCUPATIONAL
EXPOSURE
AND
RISK....................................................................................
49
7.1
Occupational
Handler
..............................................................................................
49
7.2
Occupational
Postapplication
...................................................................................
50
8.0
DATA
NEEDS
AND
LABEL
REQUIREMENTS
...............................................................
65
9.0
TOLERANCE
REASSESSMENT.......................................................................................
66
    
3
  
71
1.0
EXECUTIVE
SUMMARY
Cypermethrin
[(
±
)
­
alpha­
3­
cyano­(
3­
phenoxyphenyl)
methyl
[(
±
)
­
cis,
trans­
3(
2,2­
dichloroethenyl
2,2­
dimethylcyclopropanecarboxylate]]
and
zeta­
cypermethrin
[(
S)­
cyano(
3­
phenoxyphenyl)
methyl
±
­
cis/
trans­
3­(
2,2­
dichloroethenyl)­
2,2­
dimethylcyclopropanecarboxylate]
are
stomach
and
contact
insecticides
belonging
to
the
pyrethroid
class
of
pesticides.

Cypermethrin,
a
molecule
with
three
asymmetric
carbon
atoms,
is
a
combination
of
8
stereoisomers
with
percentage
compositions
ranging
from
11­
14%.
Cypermethrin
is
registered
for
foliar
applications
to
control
a
wide
range
of
pests,
particularly
lepidoptera,
on
food/
feed
crops
including
leafy
Brassica
greens
and
head
and
stem
Brassica
crop
subgroups,
cotton,
garlic,
lettuce
(
head),
onions
(
dry
bulb
&
green),
pecans,
and
shallots
using
ground,
sprinkler
irrigation,
or
aerial
equipment.
Cypermethrin
is
additionally
registered
as
a
soil
residual
termiticide,
for
outdoor
pest
control
to
structures
and
lawns,
indoor
pest
control
(
dilutable
formulations
for
crack
&
crevice
or
spot
treatments,
total
release
foggers
or
aerial
space
sprays),
livestock
ear
tags,
and
for
application
to
horses.
It
can
be
used
in
industrial,
commercial,
and
residential
sites.
The
single
active
ingredient
formulations
of
cypermethrin
include
the
emulsifiable
concentrate
(
EC),
the
soluble
concentrate/
liquid
(
SC/
L),
the
granular
(
G),
and
the
wettable
powder
(
WP).
Cypermethrin
is
compatible
with
a
number
of
insecticides
and
fungicides.
Tolerances
for
cypermethrin
are
listed
under
40
CFR
§
180.418(
a)(
1).

Zeta­
cypermethrin
is
an
enriched
enantiomer
of
cypermethrin
consisting
of
the
4
stereoisomers
with
an
"
S"
configuration
at
the
cyano
bearing
carbon
at
24%
each,
and
4
insecticidally
less
active
stereoisomers
at
a
concentration
of
1%
each.
Zeta­
cypermethrin
has
been
registered
on
the
same
agricultural
crops
as
cypermethrin
plus
many
more.
When
applied
on
agricultural
crops,
the
typical
use
rate
for
zeta­
cypermethrin
is
one­
half
that
for
cypermethrin
because
the
concentration
of
the
most
insecticidally
active
isomers
are
about
two
times
higher
in
zeta­
cypermethrin
than
in
cypermethrin.
Tolerances
for
zeta­
cypermethrin
are
listed
under
40
CFR
§
180.418(
a)(
2).

Hazard
Assessment
Cypermethrin
is
a
type
II
pyrethroid.
It
is
likely
that
the
toxic
action
of
pyrethroids
is
primarily
due
to
its
blocking
action
on
some
aspect
of
synaptic
function
of
the
nerve
axon.
The
fast
knockdown
of
flying
insects
could
be
the
result
of
rapid
muscular
paralysis,
suggesting
that
the
ganglia
of
the
insect
central
nervous
system
are
affected.

In
mammals,
cypermethrin
generally
affects
the
neuromuscular
system.
There
may
be
some
liver
effects
as
well;
however,
these
may
only
be
an
adaptive
response.
The
neuromuscular
effects
(
tremors,
gait
abnormalies
and
decreases
in
activity)
are
observed
across
species
(
dog
and
rat)
and
via
both
the
oral
and
inhalation
routes
of
administration.
As
with
other
pyrethroids,
the
neuromuscular
effects
do
not
appear
to
increase
in
severity
with
increasing
duration
of
exposure.
They
appear
to
be
more
of
a
transient
acute
effect
as
opposed
to
an
effect
which
appears
after
a
long­
term
accumulated
dose.
    
4
  
71
Cypermethrin
has
been
classified
as
a
Category
C,
possible
human
carcinogen,
based
on
an
increased
incidence
of
lung
adenomas
and
adenomas
plus
carcinomas
combined
in
female
mice
(
Cancer
Peer
Review
Committee,
1988).
The
evidence
was
not
considered
strong
enough
to
warrant
a
quantitative
estimation
of
human
risk.
The
endpoint
selected
for
the
chronic
population
adjusted
dose
(
cPAD)
will
be
protective
of
the
possible
carcinogenic
activity
of
this
chemical.
Structure­
activity
comparisons
with
the
pyrethroid
class
of
insecticides
indicate
that
lung
tumors
in
mice
were
induced
with
3
other
pyrethroids.

Cypermethrin
is
not
a
developmental/
reproductive
toxicant.
No
developmental
toxicity
is
observed
in
any
of
the
prenatal
developmental
toxicity
studies
and
in
the
reproduction
studies.
In
these
studies,
offspring
toxicity
was
observed
at
the
same
treatment
level
which
resulted
in
parental
systemic
toxicity.
However,
the
recently
submitted
developmental
neurotoxicity
study
did
demonstrate
a
lower
NOAEL
and
LOAEL
for
offspring
based
on
pup
weight
than
for
the
NOAEL
in
the
maternal
animals.
With
the
available
toxicity
database
at
this
time,
there
is
no
evidence
that
cypermethrin
induces
any
endocrine
disruption.

As
a
member
of
the
pyrethroid
class
of
insecticides,
cypermethrin
is
expected
to
be
a
neurotoxicant,
inducing
transient
clinical
signs
of
neurotoxicity
in
mammals,
but
not
generally
inducing
neuropathologic
lesions.
The
acute
neurotoxicity
studies
bear
this
out,
inducing
gait
abnormalities
and
other
clinical
signs
of
neurotoxicity.
The
subchronic
neurotoxicity
study
indicated
the
same
types
of
signs
and
symptoms
plus
decreased
body
weight
gain.
Similar
clinical
signs
of
neurotoxicity
were
observed
in
the
other
guideline
oral
and
inhalation
toxicity
studies
in
the
rat
and
oral
studies
in
the
dog.

FQPA
Decision
On
January
22,
2003,
the
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
determined
that
the
special
FQPA
safety
factor
should
be
reduced
to
1X
since
there
are
no
residual
uncertainties
for
pre
and/
or
post
natal
toxicity.
Based
on
the
weight
of
evidence
presented,
the
HIARC
reaffirmed
the
previous
conclusion
(
HIARC,
November
and
December,
2000)
that
a
developmental
neurotoxicity
(
DNT)
study
was
required.
Because
of
this
data
requirement,
a
10X
database
uncertainty
factor
(
UF)
was
applied.
The
DNT
study
was
recently
submitted
and
determined
to
satisfy
the
data
gap.
Thus,
the
10X
database
UF
used
in
the
previous
risk
assessment
has
now
been
reduced
to
1X.
Accordingly,
a
total
UF
of
100
(
10X
for
interspecies
and
10X
for
intraspecies
variations)
has
been
applied
to
all
dietary
and
residential
risk
assessments.
A
total
UF
of
100
has
been
applied
to
all
occupational
risk
assessments
except
for
the
long­
term
inhalation
risk
assessment,
to
which
an
UF
of
300
has
been
applied.

Since
the
recently
submitted
DNT
study
demonstrated
increased
sensitivity
for
the
pups,
the
reduction
of
the
FQPA
safety
factor
from
10X
to
1X
as
originally
assigned
by
the
HIARC
was
reconsidered.
The
conclusion
was
that
since
the
NOAELs
used
for
risk
assessment
are
essentially
equal
to
or
lower
than
the
NOAEL
for
the
DNT
study,
the
endpoints
selected
are
already
protective
of
potential
toxicity
to
the
young.
Thus,
a
FQPA
safety
factor
of
1X
is
appropriate
for
cypermethrin.
    
5
  
71
As
per
the
Office
of
Pesticide
Program s
(
OPP s)
policy,
a
reference
dose
(
RfD)
modified
by
an
FQPA
safety
factor
is
referred
to
as
a
population­
adjusted
dose
(
PAD).
As
the
FQPA
safety
factor
was
reduced
to
1X
for
cypermethrin,
the
acute
and
chronic
RfDs
(
aRfD
and
cRfD)
are
identical
to
the
acute
and
chronic
PADs
(
aPAD
and
cPAD),
respectively.
OPP
expresses
dietary
risk
as
a
percentage
of
the
aPAD
or
cPAD.
It
expresses
occupational
and
residential
risks
as
a
Margin
of
Exposure
(
MOE).
For
cypermethrin,
the
target
MOE
above
which
HED
has
no
concerns
is
100
for
occupational
and
residential
exposures.

Dose
Response
Assessment
The
toxicological
endpoints
for
use
in
human
risk
assessment
for
cypermethrin
were
selected
from
the
most
sensitive
species
from
the
combined
databases
for
both
cypermethrin
and
zetacypermethrin
The
following
endpoints
were
selected
for
estimation
of
risk:
acute
dietary
(
general
population):
a
NOAEL
of
10
mg/
kg
from
the
acute
neurotoxicity
study
in
the
rat
(
zetacypermethrin
aPAD
=
0.1
mg/
kg);
chronic
dietary:
a
NOAEL
of
6
mg/
kg/
day
from
the
chronic
feeding
study
in
the
dog
(
cPAD
=
0.06
mg/
kg/
day);
short­
term
incidental
oral
exposure:
a
NOAEL
of
10
mg/
kg/
day
from
the
acute
neurotoxicity
study
in
the
rat
(
zeta­
cypermethrin,
residential
MOE
=
100);
intermediate­
term
incidental
oral
exposure:
a
NOAEL
of
5
mg/
kg/
day
from
the
subchronic
neurotoxicity
study
in
the
rat
(
zeta­
cypermethrin,
residential
MOE
=
100);
short­
and
intermediate­
term
dermal
exposure:
no
hazard
was
identified
to
support
a
quantitation
of
risk;
long­
term
dermal
exposure:
a
NOAEL
of
6
mg/
kg/
day
from
the
chronic
feeding
study
in
the
dog
(
occupational
MOE
=
100
and
residential
MOE
=
100)
with
an
estimated
dermal
absorption
factor
of
2.5%;
and
inhalation
exposure
(
any
time
period):
a
NOAEL
of
0.01
mg/
L
(
2.7
mg/
kg/
day)
from
the
21­
day
inhalation
study
in
the
rat
(
short­
and
intermediate­
term
occupational
MOE
=
100
and
long­
term
occupational
MOE
=
300;
residential
MOE
[
all
durations]
=
100).
The
extra
3X
for
long­
term
occupational
exposure
was
selected
because
1)
the
results
of
a
21­
day
study
was
used
to
assess
long­
term
duration
inhalation
exposure
scenarios,
2)
inhalation
appears
to
be
the
most
sensitive
route
of
exposure,
and
3)
using
the
existing
oral
studies
with
a
route­
to­
route
extrapolation
would
result
in
a
less
protective
endpoint.

Residue
Chemistry
The
nature
of
the
residue
of
cypermethrin
in
livestock
and
plants
has
been
adequately
delineated.
The
residue
of
concern
for
tolerance
enforcement
and
risk
assessment
is
parent
cypermethrin.
Because
the
analytical
method
does
not
distinguish
between
residues
of
cypermethrin
and
zetacypermethrin
tolerance
levels
for
meat,
milk,
poultry,
and
egg
(
MMPE)
commodities
should
be
the
same
for
cypermethrin
and
zeta­
cypermethrin.
In
light
of
label
restrictions
and
the
different
total
application
rates
between
formulations
containing
cypermethrin
and
zeta­
cypermethrin,
different
tolerance
levels
may
be
appropriate
for
some
plants,
such
as
green
onions.

Dietary
Exposure
and
Risk
Estimates
HED
performed
a
refined
(
probabilistic)
acute
dietary
assessment
using
Pesticide
Data
Program
(
PDP)
data,
percent
crop
treated
information,
and
processing
factors
where
appropriate.
The
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
    
6
  
71
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
The
acute
dietary
risk
estimates
are
below
the
Agency's
level
of
concern
at
the
99.9th
exposure
percentile
for
the
general
U.
S.
population
(
2.6%
aPAD)
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
was
children
1­
2
years
old
at
6.1%
aPAD.

HED
performed
a
refined
chronic
dietary
assessment
using
PDP
data,
percent
crop
treated
information,
and
processing
factors
where
appropriate.
The
assessment
was
conducted
using
DEEM­
FCID
 
,
Version
1.3.
The
chronic
risk
estimates
are
below
the
Agency s
level
of
concern
for
the
general
U.
S.
population
(
0.07%)
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
was
children
1­
2
years
old
at
0.16%
of
the
cPAD.

Residential
(
non­
occupational)
Exposure
and
Risk
Estimates
Cypermethrin 
Residential
Handler
No
short­
term
dermal
exposures
or
risks
were
assessed
for
cypermethrin,
since
no
dermal
endpoints
of
concern
were
identified.
EPA
does
not
anticipate
that
residential
handlers
would
have
intermediate­
or
long­
term
exposures
to
cypermethrin
or
zeta­
cypermethrin.
Therefore,
no
intermediate­
or
long­
term
dermal
or
inhalation
exposures
or
risks
were
assessed.
EPA
did
assess
short­
term
inhalation
exposures
and
risks
to
residential
handlers.
Residential
inhalation
risks
are
below
HED's
level
of
concern
(
i.
e.,
MOE
>
100)
for
all
non­
occupational
handler
scenarios.
A
granular
product
was
registered
on
02/
23/
06
(
reg
#
28293­
367).
This
is
used
on
lawns
and
outside
of
homes
to
kill
fire
ants.
Similar
products
are
registered
with
liquid
zeta­
cypermethrin
and
liquid
and
wettable
powder
cypermethrin
formulations.
No
quantitative
risk
assessment
has
been
conducted
for
cypermethrin
granular
formulation.
However,
the
estimates
for
cypermethrin
and
zeta­
cypermethrin
residential
exposure
are
acceptable
and
HED
believes
the
risk
for
granular
cypermethrin
will
not
exceed
that
for
liquid
products.

Zeta­
Cypermethrin 
Residential
Handler
There
are
no
residential
handler
scenarios
for
zeta­
cypermethrin.
All
registered
uses
of
zetacypermethrin
are
for
occupational
use
only.

Cypermethrin 
Residential
Postapplication
EPA
assessed
postapplication
risks
to
toddlers
from
incidental
oral
ingestion
using
a
short­
term
incidental
oral
endpoint
(
10
mg/
kg/
day)
for
cypermethrin.
The
results
indicate
that
risks
from
short­
term
exposures
were
below
HED's
level
of
concern
(
i.
e.,
MOE
>
100)
for
all
scenarios
evaluated.

Zeta­
Cypermethrin 
Residential
Postapplication
EPA
assessed
postapplication
risks
to
toddlers
from
incidental
oral
ingestion
using
a
short­
term
incidental
oral
endpoint
(
10
mg/
kg/
day)
for
zeta­
cypermethrin.
For
residential
postapplication
risks,
MOEs
are
not
a
concern
for
any
of
the
oral
non­
dietary
scenarios,
because
they
were
below
HED's
level
    
7
  
71
of
concern.

Drinking
Water
Exposure
Based
on
the
available
data,
cypermethrin/
zeta­
cypermethrin
is
a
moderately
persistent
chemical
that
primarily
degrades
by
photolysis
in
water
and
biodegradation.
Cypermethrin
can
also
contaminate
surface
waters
through
spray
drift.
Depending
on
the
environmental
circumstances,
it
may
persist
for
periods
of
months
posttreatment.
Since
zeta­
cypermethrin
is
preferentially
associated
to
the
soils,
the
fraction
of
the
chemical
in
the
water
column
should
be
small.

Estimated
Environmental
Concentrations
(
EECs)
for
cypermethrin
were
determined
using
PRZM/
EXAMS
for
surface
water
(
Tier
2
model)
and
SCIGROW
for
ground
water
(
Tier
1
model).
For
surface
water,
the
acute
(
peak)
value
is
1.04
ppb
and
the
annual
average
value
is
0.013
ppb.
The
groundwater
screening
concentration
for
use
in
acute
and
chronic
risk
assessment
is
0.0036
ppb.
These
EECs
are
based
on
maximum
application
rates
and
a
default
percent
crop
area
(
PCA)
of
0.87.
These
EEC
values
represent
upper­
bound
estimates
of
the
concentrations
that
might
be
found
in
surface
water
and
groundwater
based
on
the
use
of
cypermethrin
on
brassica
vegetables,
which
has
the
highest
application
rate
among
both
cypermethrin
and
zeta­
cypermethrin
on
all
crops
over
which
the
chemicals
are
applied.

Aggregate
Risk
Estimates
The
current
uses
for
cypermethrin
encompass
agricultural
use
sites
and
nonoccupational
(
residential)
uses.
Therefore,
when
addressing
aggregate
exposures,
the
dietary
pathways
of
food
and
drinking
water
plus
the
residential
uses
were
considered,
as
appropriate.

Acute
(
food
and
water)
Aggregate
Acute
aggregate
risk
estimates
associated
with
exposure
to
cypermethrin
residues
in
food
and
water
do
not
exceed
HED's
level
of
concern.
Based
on
the
refined
dietary
assessment
results,
the
acute
dietary
risk
estimates
are
below
the
Agency s
level
of
concern
at
the
99.9th
exposure
percentile
for
the
general
U.
S.
population
and
all
population
subgroups.

EFED
provided
a
maximum
EEC
level
of
1.04
ppb
in
surface
water
and
0.0036
ppb
in
ground
water.
For
comparison
with
these
EECs,
HED
has
calculated
drinking
water
levels
of
comparison
(
DWLOCs)
based
on
dietary
exposure
estimates
and
default
values
for
body
weight
and
water
consumption.
The
lowest
acute
DWLOC
of
940
ppb
for
children
1­
2
years
old
is
higher
than
the
peak
EEC
of
1.04
ppb
in
surface
water
and
the
maximum
EEC
for
ground
water
of
0.0036
ppb;
therefore,
acute
aggregate
risk
estimates
associated
with
exposure
to
cypermethrin
residues
in
food
and
water
do
not
exceed
HED s
level
of
concern.

Chronic
(
food
and
water)
Aggregate
Chronic
dietary
estimates
of
exposure
from
food
were
taken
from
the
dietary
exposure
model
results
described
above.
The
chronic
risk
estimates
are
below
the
Agency s
level
of
concern
for
the
general
U.
S.
population
and
all
population
subgroups.
    
8
  
71
EFED
provided
average
annual
EECs
of
0.013
ppb
for
surface
water
and
0.0036
ppb
for
ground
water.
For
comparison
with
these
EECs,
HED
has
calculated
DWLOCs
based
on
dietary
exposure
estimates
and
default
values
for
body
weight
and
water
consumption.
The
population
subgroup
children
1­
2
years
old
has
the
lowest
chronic
DWLOC
value
of
600
ppb.
The
chronic
DWLOCs
for
all
population
subgroups
are
greater
than
both
the
surface
water
and
ground
water
EECs;
therefore,
chronic
aggregate
risk
estimates
associated
with
exposure
to
cypermethrin
residues
in
food
and
water
do
not
exceed
HED s
level
of
concern.

Short­
Term
(
food,
water,
and
residential
uses)
Aggregate
The
incidental
oral
residential
exposure
value
selected
for
the
aggregate
analysis
was
based
on
hand
to
mouth
activity
from
indoor
surfaces
following
crack
and
crevice
treatment
as
this
scenario
resulted
in
the
highest
calculated
exposure
level,
and,
therefore,
is
protective
for
all
other
scenarios.
The
lowest
DWLOC
value
of
890
ppb
was
calculated
for
children
1­
2
years
old
and
this
level
is
higher
than
the
surface
and
ground
water
EECs
of
0.013
and
0.0036
ppb,
respectively.
Thus,
short­
term
aggregate
risk
does
not
exceed
HED's
level
of
concern
for
any
of
the
residential
exposure
scenarios.

Occupational
Exposure
and
Risk
Estimates
­
Handlers
When
data
were
available
to
assess
risks,
short­
and
intermediate­
term
inhalation
risks
to
occupational
handlers
are
below
the
Agency's
level
of
concern
for
risk
assessments
(
i.
e.,
MOE
 
100)
at
baseline
(
i.
e.,
no
respirator)
for
all
the
formulations,
except
wettable
powder
formulations.
For
several
scenarios
involving
wettable
powder
formulation,
risks
are
above
HED's
level
of
concern
(
i.
e.,
MOEs
are
less
than
100)
at
baseline
(
i.
e.,
no
respirator).
The
addition
of
a
dust/
mist
filtering
respirator
reduces
the
risks
to
below
HED's
level
of
concern
for
all
these
scenarios,
except
mixing/
loading
to
support
aerial
or
groundboom
applications
to
agricultural
uncultivated
areas,
fencerows,
and
hedgerows
and
mixing/
loading
to
support
aerial
applications
to
sodfarms.
For
these
three
scenarios,
engineering
controls
(
i.
e.,
water­
soluble
packaging)
are
necessary
to
reduce
the
inhalation
risks
to
below
HED's
level
of
concern.
EPA
has
insufficient
data
to
assess
exposures
to
pilots
in
open
cockpits.
Inhalation
risks
to
pilots
in
enclosed
cockpits
(
engineering
control
scenario)
were
not
a
concern
for
all
agricultural
crop
scenarios.
No
data
are
available
to
assess
inhalation
risks
during
the
application
of
impregnated
eartags
to
horses,
however,
the
risks
are
expected
to
be
well
below
the
inhalation
risks
(
MOE=
15,000)
from
applications
using
a
readyto
use
aerosol
can
(
considered
to
represent
a
worst
case
exposure
scenario
for
applications
of
impregnated
eartags
to
horses).
A
granular
product
was
registered
on
02/
23/
06
(
reg
#
28293­
367).
This
is
used
on
lawns
and
outside
of
homes
to
kill
fire
ants.
Similar
products
are
registered
with
liquid
zeta­
cypermethrin
and
liquid
and
wettable
powder
cypermethrin
formulations.
No
quantitative
risk
assessment
has
been
conducted
for
cypermethrin
granular
formulation.
However,
the
estimates
for
cypermethrin
and
zeta­
cypermethrin
occupational
exposure
are
acceptable
and
HED
believes
the
risk
for
granular
cypermethrin
will
not
exceed
that
for
liquid
products.

Short­
and
intermediate­
term
dermal
risks
were
not
assessed
for
occupational
handlers,
since
no
short­
or
intermediate­
term
dermal
endpoints
were
identified.
    
9
  
71
A
few
occupational
handler
exposure
scenarios
may
be
considered
long­
term,
including
applications
to
residential,
commercial,
and
industrial
turf
by
commercial
lawn
care
operators
and
applications
in
and
around
residential,
commercial,
and
industrial
premises
by
commercial
pest
control
operators.
Since
the
toxicological
endpoints
of
concern
for
long­
term
exposures
are
based
on
similar
adverse
effects,
long­
term
dermal
and
inhalation
risks
must
be
combined
for
occupational
scenarios
where
long­
term
exposures
are
anticipated.
The
target
MOEs
for
long­
term
occupational
workers
are
100
for
dermal
risk
and
300
inhalation
risk.
Therefore,
the
MOEs
were
combined
to
identify
an
aggregate
risk
index
(
ARI).
An
ARI
was
used
since
the
target
MOE
values
for
inhalation
and
dermal
exposure
were
different.
The
target
ARI
is
1,
therefore,
ARIs
of
less
than
1
indicate
risks
of
concern.

Aggregated
long­
term
dermal
and
inhalation
risks
are
below
HED's
level
of
concern
for
all
scenarios
involving
liquid
formulations
at
baseline
attire
or
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire.
Aggregated
long­
term
dermal
and
inhalation
risks
are
below
HED's
level
of
concern
for
all
scenarios
involving
wettable
powder
formulations
at
baseline
attire
or
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire,
except
mixing/
loading/
applying
wettable
powders
with
a
low­
pressure
handwand
sprayer.
Risks
were
reduced
to
below
HED's
level
of
concern
with
the
addition
of
a
dust/
mist
respirator
and
chemical­
resistant
gloves
to
baseline
attire
for
these
scenarios,
except
for
applications
to
residential,
commercial
and
industrial
lawns
(
0.6
lb
ai/
A).
Even
with
the
addition
of
maximum
personal
protection
equipment
(
PPE),
combined
longterm
dermal
and
inhalation
risks
for
mixing/
loading/
applying
with
low
pressure
handwand
sprayer
to
residential,
commercial
and
industrial
lawns
were
still
above
the
HED's
level
of
concern
(
i.
e,
ARI
<
1).

Zeta­
Cypermethrin
When
data
were
available
to
assess
risks,
short­
and
intermediate­
term
inhalation
risks
to
occupational
handlers
are
below
the
Agency's
level
of
concern
for
risk
assessments
(
i.
e.,
MOE
 
100)
at
baseline
(
i.
e.,
no
respirator).
EPA
has
insufficient
data
to
assess
exposures
to
pilots
in
open
cockpits.
Inhalation
risks
to
pilots
in
enclosed
cockpits
(
engineering
control
scenario)
were
not
a
concern
for
all
agricultural
crop
scenarios.
No
data
are
available
to
assess
inhalation
risks
during
the
application
of
dusts
via
a
mechanical
duster
and
application
of
ready­
to­
use
eartags.

Short­
and
intermediate­
term
dermal
risks
were
not
assessed
for
occupational
handlers,
since
no
short­
or
intermediate­
term
dermal
endpoints
were
identified.

A
few
occupational
handler
exposure
scenarios
may
be
considered
long­
term,
including
applications
to
residential,
commercial,
and
industrial
turf
by
commercial
lawn
care
operators
and
applications
by
pest
control
operators.
When
data
were
available
to
assess
risks,
long­
term
risks
to
occupational
handlers
were
above
the
Agency's
level
of
concern
for
risks
(
i.
e,
ARI
<
1)
at
baseline
attire
(
i.
e.,
long­
sleeve
shirt,
long
pants,
shoes,
socks,
and
no
respirator).
For
mixing/
loading/
applying
liquid
concentrates
with
a
handgun
sprayer,
no
data
are
available
to
assess
dermal
exposures
at
baseline
attire.
However,
the
combined
long­
term
risks
were
below
HED's
level
of
concern
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire.
    
10
  
71
Chronic
exposures
were
only
expected
for
turf
(
LCOs)
and
termiticides
(
PCOs)
applications
in
industrial,
commercial,
and
residential
settings.
The
risk
estimates
are
not
a
concern
at
baseline
attire
for
mixing/
loading/
applying
liquids
and
water
soluble
bags
to
turfgrass
using
handgun
equipment
(
ORETF
data).
Using
PHED
data,
risk
estimates
are
not
a
concern
at
baseline
attire
for
mixing/
loading/
applying
liquids
to
turfgrass
using
a
low
pressure
handwand,
mixing/
loading/
applying
wettable
powders
to
standing
wood
(
termites)
using
a
paint
brush,
and
mixing/
loading/
applying
wettable
powders
to
wood
using
a
termiticides
injector.
The
risks
are
not
a
concern
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire
for
mixing/
loading/
applying
wettable
powders
to
turfgrass
using
handgun
equipment
(
ORETF
data).
Using
PHED
data,
risk
estimates
are
not
of
concern
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire
for
mixing/
loading/
applying
with
low­
pressure
handwand
sprayers
(
termiticides
applications),
backpack
sprayers,
and
paintbrushes
(
all
other
termite
applications).

For
the
applications
in
industrial,
commercial,
and
residential
settings,
the
inhalation
risk
estimates
are
not
a
concern
at
baseline
attire
for
all
mixing/
loading/
applying
scenarios.
Although
there
is
no
inhalation
exposure
data
for
applying
ready­
to­
use
ear
tags
to
horses,
the
inhalation
risk
estimates
from
this
exposure
pattern
is
not
expected
to
be
a
concern
because
of
the
low
volatility
of
zetacypermethrin
the
dissipating
effects
of
wind
likely
in
outdoor
conditions,
and
the
relatively
low
amounts
of
zeta­
cypermethrin
in
ear
tags.

Occupational
Exposure
and
Risk
Estimates
­
Postapplication
EPA
did
not
assess
occupational
postapplication
risks
to
agricultural
workers
following
treatments
to
agricultural
crops,
since
no
short­
or
intermediate­
term
dermal
endpoints
of
concern
were
identified
and
long­
term
dermal
exposures
are
not
expected
for
tasks
involving
any
of
the
registered
crop
use
patterns.

Data
Gaps
and
Tolerance
Reassessment
Refer
to
Sections
8.0
and
9.0
of
this
document
for
specific
data
gaps
and
tolerance
reassessment.
    
11
  
71
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION
Chemical
Structure
Cypermethrin
(
 ­
cyano
(
3­
phenoxyphenyl)
methyl
(
±
)
­
cis­
trans
3­(
2,2­
dichloroethenyl)­
2,2
dimethylcyclopropanecarboxylate)
is
a
type
II
pyrethroid
insecticide
(
i.
e.
it
has
a
cyano
group
at
the
 
carbon
position
of
the
alcohol
moiety
and
it
is
more
effective
when
the
ambient
temperature
is
raised).

Cypermethrin
has
the
following
structure:

Physical/
Chemical
Properties
Empirical
Formula:
C22H19Cl2
NO3
Molecular
Weight:
416.3
Melting
Point:
60­
80
°
C
Boiling
Point:
216
°
C
Density:
1.204
g/
mL
at
25
°
C
Vapor
Pressure:
3.1E­
9
mm
Hg
at
20
°
C
Water
Solubility:
7.6
ppb
at
25
°
C
Log
P
(
octanol­
water):
6.60
Cypermethrin
is
a
combination
of
8
stereoisomers
with
percentage
compositions
ranging
from
11­
14%,
and
very
low
volatility
and
water
solubility.
This
results
in
lower
likelihood
of
inhalation
exposure.
The
high
octanol­
water
partition
coefficient
is
consistent
with
the
observed
residue
preference
for
fatty
tissues
and
milk
fat
in
livestock.
    
12
  
71
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
Table
1.
Acute
Toxicity
of
Cypermethrin
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Categor
y
870.1000
Acute
Oral
­
rat
00056800
LD50
(
M):
247
mg/
kg
(
F):
309
mg/
kg
females
Deaths:
 
150
mg/
kg,
usually
in
first
day.
Clinical
signs
of
neurotoxicity,
gait
abnormalities;
some
persisting
to
14
days.
II
870.1100
Acute
Dermal
Rat
Rabbit
00056800
00056800
LD50
>
4920
mg/
kg/
day.
Clinical
signs
of
neurotoxicity.

Abraded
skin:
LD50
>
2460
mg/
kg.
Lacrimation,
discharge
from
the
eye
and
"
nervous
and
shaking".
III
III
870.1200
Acute
Inhalation
­
rat
42395702
LC50:
_
(
not
calculated
but
higher
than
_)
LC50:
_
2.5
(
1.6­
3.4)
mg/
L.
Clinical
signs
of
neurotoxicity.
MMAD
ranged
from
2.22
to
2.62
µ
m
IV
870.2400
Primary
Eye
Irritation
00056800
Slight
redness
of
conjunctivae,
chemosis
&
discharge.
Persisted
to
day
7.
III
870.2500
Primary
Skin
Irritation
00056800
Slight
to
mild
erythema
on
intact
&
abraded
skin.
Reversed
by
48
hours.
Primary
Irritation
Index:
0.71
IV
870.2600
Dermal
Sensitization
00056800
40377701
Not
a
sensitizer
in
Buehler
assay.
Moderate
sensitizer
in
Magnusson
Kligman
Maximization
method.
N/
A
    
13
  
71
Table
2.
Subchronic,
Chronic
and
Other
Toxicity*

Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.3100
90­
Day
oral
toxicity
­
rat
MRID
00056802
&
92027034
(
1980)/
Unacceptable
ppm
=
0,
75,
150
or
1500
mg/
kg/
day
=
0,
3.75,
7.5
or
75
NOAEL
=
7.5
mg/
kg/
day
LOAEL
=
75
mg/
kg/
day
based
on
decreased
body
weight
in
both
sexes.

870.3100
90­
Day
oral
toxicity
­
rat:
zetacypermethrin
MRID
41776101
(
1990)/
Acceptable
ppm
=
0,
10,
50,
150,
250,
500
or
900
mg/
kg/
day
=
M:
0,
0.6,
2.7,
8.4,
13.8,
28.2
or
55.7;
F:
0,
0.6,
3.3,
9.6,
16.3,
32.2
or
65.2
NOAEL
=
M
=
13.8
(
M),
16.3
(
F)
mg/
kg/
day
LOAEL
=
28.2
mg/
kg/
day
(
M)
based
on
decreased
body
wt,
body
wt
gain
and
food
consumption;
at
55.7
mg/
kg/
day,
mortality
as
well
as
decreased
RBC,
WBC,
HGB
&
HCT
plus
increase
in
BUN.
32.2
mg/
kg/
day
(
F)
based
on
decreased
body
wt,
body
wt
gain
and
food
consumption
as
well
as
interference
with
estrous
cycle
and
decreased
glucose;
mortality
at
65.2
mg/
kg/
day.

870.3150
90­
Day
oral
toxicity
in
dogs
(
feeding)
MRID
44527002
(
1994)/
Acceptable
ppm
=
0,
300,
600,
800
or
1100
mg/
kg/
day
=
M:
0,
10.4,
20.7,
24.6
or
37.0
F:
0,
12.2,
25.4,
34.3
or
45.2
NOAEL
=
24.6
(
M),
34.3
(
F)
mg/
kg/
day
LOAEL
=
37.0
(
M),
45.2
(
F)
mg/
kg/
day
based
on
tremors
as
well
as
decreased
body
wt
and
body
wt
gains
in
both
sexes.

870.3150
90­
Day
oral
toxicity
in
dogs
(
feeding)
MRID
00112929
(
1977)/
Unacceptable
ppm
=
0,
5,
50,
500
or
1500
mg/
kg/
day
=
0,
0.125,
1.25,
12.5
or
37.5
NOAEL
=
12.5
mg/
kg/
day
LOAEL
=
37.5
mg/
kg/
day
based
on
clinical
signs
(
whole
body
tremors,
exaggerated
gait,
ataxia,
incoordination,
hyperaesthesia,
licking
&
chewing
of
paws;
diarrhea,
anorexia)
&
decreased
body
wt
870.3200
21­
Day
dermal
toxicity
­
rat:
zetacypermethrin
MRID
45010401
(
1999)/
Acceptable
mg/
kg/
day
=
0,
100,
500
or
1000
NOAEL
=
systemic:
1000
mg/
kg/
day.
Dermal:
<
100
mg/
kg/
day
LOAEL
=
systemic:
>
1000
mg/
kg/
day
(
LIMIT
DOSE).
Dermal:
100
mg/
kg/
day,
based
on
erythema
&/
or
eschar
1/
10
M
&
6/
10
F;
desquamation
0/
10
M
&
2/
10
F
(
no
effects
in
any
M
or
F
controls).

870.3200
21­
Day
dermal
toxicity
­
rabbit
MRID
00090035
(
1981)/
Acceptable
mg/
kg/
day
=
0,
2,
20,
200
NOAEL
=
Systemic
nonabraded
animals:
200
mg/
kg/
day
(
HDT)
Dermal:
20
mg/
kg/
day
LOAEL
=
Systemic
nonabraded
animals:
>
200
mg/
kg/
day
(
HDT).
    
14
  
71
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
Dermal:
200
mg/
kg/
day
based
on
signs
of
dermal
irritation.

870.3465
21­
Day
inhalation
toxicity
­
rat
MRID
43507101
(
1994)/
Acceptable
mg/
L
=
0,
0.01,
0.05
or
0.25
(
nose
only)
NOAEL
=
0.01
mg/
L
LOAEL
=
0.05
mg/
L
based
on
decreases
in
body
weight.

870.3700a
Prenatal
developmental
in
rats
MRID
00056804,
92027039
&
92027601
(
1978)/
Acceptable
mg/
kg/
day
=
0,
17.5,
35
or
70
Maternal
NOAEL
=
17.5
mg/
kg/
day
LOAEL
=
35
mg/
kg/
day
based
on
decreased
body
wt
gain;
at
70mg/
kg/
day,
splayed
limbs,
spasms
&
hypersensitivity
to
noise
&
convulsions.
Developmental
NOAEL
=
70
mg/
kg/
day
(
HDT).
LOAEL
=
>
70
mg/
kg/
day
.

870.3700a
Prenatal
developmental
in
rats
­
zetacypermethrin
MRID
41776102
(
1990)/
Acceptable
mg/
kg/
day
=
0,
5,
12.5,
25
or
35
Maternal
NOAEL
=
12.5
mg/
kg/
day
LOAEL
=
25
mg/
kg/
day,
based
on
ataxia,
urine­
stained
abdominal
fur,
fecal­
stained
perineal
fur,
decreased
food
consumption
&
decreased
body
wt
gain.
Developmental
NOAEL
 
35
mg/
kg/
day
LOAEL
=
>
35
mg/
kg/
day
870.3700b
Prenatal
developmental
in
rabbits
MRID
43776301
&
43776302
(
1994)/
Acceptable
mg/
kg/
day
=
0,
100,
450
or
700
Maternal
NOAEL
=
100
mg/
kg/
day
LOAEL
=
450
mg/
kg/
day
based
on
decreased
body
wt
gain;
anorexia,
abdomino­
genital
staining,
decreased
feces
&
red
or
pink
material
in
the
pan
(
few
does).
At
700,
anorexia,
abdomino­
genital
staining,
decreased
feces
&
red
or
pink
material
in
the
pan
were
observed.
Developmental
NOAEL
=
700
mg/
kgday
LOAEL
=
>
700
mg/
kg/
day
(
highest
dose
tested)

870.3700b
Prenatal
developmental
in
rabbits
MRID
00056805
(
1978)/
Unacceptable
[
dosed
by
capsule]
mg/
kg/
day
=
0
(
empty),
0
(
corn
oil),
3,
10
or
30
Maternal
NOAEL
=
30
mg/
kg/
day
LOAEL
>
30
mg/
kg/
day
(
HDT)
Developmental
NOAEL
=
30
mg/
kg/
day
LOAEL
=
>
30
mg/
kg/
day
(
highest
dose
tested)

870.3800
Reproduction
and
fertility
effects
MRID
00112912,
42068504
&
92027040
(
1982)/
Acceptable
ppm
=
0,
50,
150
or
1000/
750
(
to
750
after
wk
12
due
to
severe
neurological
signs)
mg/
kg/
day
=
0,
2.5,
7.5
or
50/
37.5
[
2
litters/
generation]
Parental/
Offspring
NOAEL
=
7.5
mg/
kg/
day
LOAEL
=
50/
37.5
mg/
kg/
day
based
on
decreased
body
wt
gain
in
both
sexes
and
decreased
mean
litter
weight
gain
during
lactation.

870.3800
Reproduction
and
fertility
effects
MRID
00090040
(
1979)/
Unacceptable
ppm
=
0,
10,
100
or
500
Parental/
Systemic
NOAEL
=
5
mg/
kg/
day
LOAEL
=
25:
based
on
decreased
body
wt
gain.
Offspring
NOAEL
=
5
mg/
kg/
day
    
15
  
71
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
mg/
kg/
day
=
0,
0.5,
5
or
25
[
2
litters/
generation]
LOAEL
=
25:
based
on
decreased
body
wt
gain
(
lactation
day
21).

870.3800
Reproduction
and
fertility
effects
­
zeta­
cypermethrin
MRID
41968204
(
1991)/
Acceptable
ppm
=
0,
7.5,
25,
100,
375
or
750
mg/
kg/
day
=
0,
0.5,
1.8,
7,
27
or
45
[
1
litter/
generation]
Parental/
Systemic
NOAEL
=
7
mg/
kg/
day
LOAEL
=
27
mg/
kg/
day
based
on
decreased
body
wt
gain
(
most
noticeable
during
lactation)
and
increased
relative
brain
wts
M
&
F;
at
45
mg/
kg/
day,
some
neurotoxic
clinical
signs
in
a
few
animals
(
some
mortality)
.
Offspring
NOAEL
=
7
mg/
kg/
day
LOAEL
=
27
mg/
kg/
day,
based
on
decreased
body
wt
gain
during
lactation;
at
45
mg/
kg/
day,
pup
mortality.

870.4100a
Chronic
toxicity
rats
MRID
00112910
&
9202741
(
1982)/
Acceptable
ppm
=
0
#
1,
0
#
2,
20,
150
or
1500
mg/
kg/
day
=
0,
0,
1,
7.5
or
75
NOAEL
=
7.5
mg/
kg/
day
LOAEL
=
75
mg/
kg/
day
based
on
decreases
in
body
wt
gain
(
both
sexes)

870.4100b
Chronic
toxicity
dogs
(
capsule)
MRID
00112909,
42068503
&
92027037
(
1982)/
Acceptable
mg/
kg/
day
=
0,
1,
5
or
15
NOAEL
=
1
mg/
kg/
day
LOAEL
=
5
mg/
kg/
day
based
on
gastrointestinal
effects
(
liquid
stool);
at
15
mg/
kg/
day,
body
tremors,
gait
abnormalities,
uncoordination,
disorientation
&
hypersensitivity
to
noise
plus
decrease
in
body
weight.

870.4100b
Chronic
toxicity
dogs
(
feeding)
MRID
44536801
(
1995)/
Acceptable
ppm
=
0,
100,
200,
600
or
1100
mg/
kg/
day
=
M:
0,
2.9,
6.0,
20.4,
33.9
F:
0,
3.3,
5.7,
18.1,
38.1
NOAEL
=
6
mg/
kg/
day
(
M),
5.7
mg/
kg/
day
(
F)
LOAEL
=
20.4
mg/
kg/
day
(
M)
based
on
abnormal
clinical
signs
(
tremors,
excessive
salivation,
irregular
gait);
at
33.9
mg/
kg/
day,
mortality.
18.1
mg/
kg/
day
(
F)
based
on
decreased
body
wt
&
wt
gains.

870.4200
Carcinogenicity
rats
MRID
00112910
&
9202741
(
1982)/
Acceptable
ppm
=
0
#
1,
0
#
2,
20,
150
or
1500
mg/
kg/
day
=
0,
0,
1,
7.5
or
75
NOAEL
=
7.5
mg/
kg/
day
LOAEL
=
75
mg/
kg/
day
based
on
decreases
in
body
wt
gain
(
both
sexes).
No
evidence
of
carcinogenicity
870.4300
Carcinogenicity
mice
MRID
00112911
&
92027038
(
1982)/
Acceptable
ppm
=
0
#
1,
0
#
2,
100,
400
or
1600
mg/
kg/
day
=
0,
0,
14,
57
or
229
NOAEL
=
14
mg/
kg/
day
LOAEL
=
57
mg/
kg/
day
(
M)
based
on
increased
absolute
(
20%)
liver
wts
Females,
there
was
a
15%
increase
in
relative
liver
wts
only
at
229
mg/
kg/
day.
CANCER:
positive
for
induction
of
benign
alveologenic
neoplasms.
    
16
  
71
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
[
M
=
97
weeks;
F
=
101
weeks]

870.5265
Salmonella
typhimurium
&
S.
cerevisiae
reverse
mutation
assay
MRIDs
00090037,
92027042,
92027062,
00090036,
00126834
(
1981)/
Acceptable
4,
20,
100,
500,
2500
µ
g/
plate
Negative
up
to
doses
of
2500
µ
g/
plate.

870.5380
in
vivo
cytogenetics
MRIDs
0090038,
92027043
(
1980)/
Acceptable
0,
20,
40
mg/
kg
No
evidence
of
structural
chromosomal
aberrations
in
rat
bone
marrow
at
20
or
40
mg/
kg.

870.5450
Dominant
lethal
assay
in
the
rodent
MRID
00090039
1980/
Acceptable
0,
2.5,
5,
7.5,
10
mg/
kg/
day
for
5
days
No
evidence
of
dominant
lethal
activity
in
CD­
1
strain
mice
up
to
10
mg/
kg/
day
for
five
consecutive
days.

870.5550
Unscheduled
DNA
synthesis
in
mammalian
cells
in
culture
MRID
41599801
(
1990)/
Acceptable
100,
200
mg/
kg
No
unscheduled
DNA
synthesis
was
observed
at
any
dose
level
up
to
200mg/
kg
in
corn
oil
in
Alpk:
APfSD
strain
rats
(
males)
assessed
4
and
12
hours
post
dosing.
200
mg/
kg
dose
was
considered
near
the
MTD.

870.6200a
Acute
neurotoxicity
screening
battery
MRID
43152001
(
1994)/
Acceptable
mg/
kg
=
0,
30,
100
or
200
NOAEL
=
30
mg/
kg/
day
LOAEL
=
100
mg/
kg
based
primarily
on
ataxia
and
related
conditions
(
staggered
or
impaired
gait,
decreased
activity,
splayed
hindlimbs
and
limp
conditions
in
addition
to
decreased
motor
activity
in
males
and
females
on
days
0,
1
or
2).

870.6200a
Acute
neurotoxicity
screening
battery
MRID
N/
A
1993/
Acceptable
mg/
kg
=
0,
20,
60,
120
LITERATURE
STUDY
NOAEL
=
<
20
mg/
kg/
day
LOAEL
=
20
mg/
kg
based
on
decreased
motor
activity
and
gait
abnormalities.
(
Conducted
at
RTP).

870.6200a
Acute
neurotoxicity
screening
battery
­
zeta­
cypermethrin
MRID
44962201
(
1998)/
Acceptable
mg/
kg/
day
=
0,
10,
50
or
250
NOAEL
=
10
mg/
kg/
day
LOAEL
=
50
mg/
kg/
day
based
on
clinical
signs
(
abdominogenital
staining,
oral
discharge,
splayed
hindlimbs,
staggered
gait
&
tremors);
FOB
findings
(
abnormal
mobile
posture,
splayed
hindlimbs,
soiled
fur
&
unable
to
walk);
at
250,
more
severe
findings.

870.6200b
Subchronic
neurotoxicity
screening
battery
MRID
43152002
1993/
Acceptable
ppm
=
0,
500,
1300
or
1700
mg/
kg/
day
=
M:
0,
31,
77
or
102;
F:
0,
37,
95
or
NOAEL
=
31
mg/
kg/
day
LOAEL
=
77
mg/
kg/
day
based
on
the
following:
males:
decreased
body
weight
gain
and
increased
landing
foot
splay;
females:
ataxia,
splayed
hindlimbs,
impaired
gait
and
decreased
feces
as
well
as
decreased
body
weight
gain.
    
17
  
71
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
121
870.6200b
Subchronic
neurotoxicity
screening
battery
­
zeta­
cypermethrin
MRID
44962202
(
1999)/
Acceptable
ppm
=
0,
75,
400
or
750
mg/
kg/
day
=
M:
0,
5.0,
26.3
or
47.2;
F:
0,
5.9,
31.5
or
55.6
NOAEL
=
5.0
mg/
kg/
day
(
M);
31.5
mg/
kg/
day
(
F)
LOAEL
=
26.3
mg/
kg/
day
(
M)
based
on
decreased
motor
activity,
increased
landing
foot
splay,
and
decreased
body
weights,
body
weight
gains,
and
food
consumption;
55.6
mg/
kg/
day
(
F)
based
on
decreased
body
weights,
body
weight
gains,
and
food
consumption.

870.6300.
Developmental
Neurotoxicity
screening
battery.
MRID
46670402,
46538902,
46670401
and
46670403.
Acceptable/
Non­
guideline.
Ppm=
0,
50,
125
or
300
ppm.
Mg/
kg/
day
=
0,
2.9,
7.4
or
17.3.
Maternal:
LOAEL
>
17.3
mg/
kg/
day
(
highest
dose
tested
­
no
effects).
Offspring:
NOAEL
=
7.4
mg/
kg/
day
LOAEL
=
17.3
mg/
kg/
day.
Based
on
reduced
body
weight
and
(
females
only);
marginal/
suggestive
changes
in
brain
morphometry
were
seen
at
high
dose
only.

870.7485
Metabolism
and
pharmacokinetics
41551102
­
04
(
1977­
78)/
Acceptable
0.61
mg/
animal;
1.3mg/
kg;
1
mg/
kg
or
less
Several
studies
with
both
rats,
dogs
and
mice
are
available
to
support
the
requirement
for
metabolism
in
mammals.
Some
of
these
studies
assess
individual
cis
and
trans
radiolabelled
isomers
and
other
studies
assess
the
metabolism
of
cypermethrin
with
the
label
in
either
the
cyclopropyl
of
the
phenoxybenzyl
ring.
In
general
the
following
has
been
demonstrated
from
these
studies:
cypermethrin
is
readily
absorbed
from
the
gastrointestinal
tract
and
extensively
metabolized.
It
mostly
excreted
in
the
urine
that
contains
several
characterized
metabolites
derived
from
conjugation
of
the
hydrolysis
products
of
the
parent
compound
following
cleavage
of
the
esteratic
linkage
site.

870.7485
Metabolism
and
pharmacokinetics
43261603
(
1992)/
Acceptable
31.03
mg
Mean
total
DCVA
excretion
was
0.33%
of
the
administered
dose.
However,
considering
that
DCVA
is
further
metabolized
this
value
would
under
estimate
dermal
absorption.
The
sum
of
3PBA
and
4OH3PBA
excretion
ranged
from
0.85
to
1.77%
(
mean
1.23%).
Because
cypermethrin
is
hydrolized
to
yield
equimolar
quantities
of
DCVA
and
3PBA
these
values
are
not
additive.

870.7600
Dermal
penetration
N/
A
No
study
is
available.

*
zeta­
cypermethrin
is
bridged
to
database
with
cypermethrin.
Therefore,
selected
studies
on
both
are
included.
Studies
are
conducted
with
cypermethrin
unless
specified
otherwise.

With
the
exception
of
the
developmental
neurotoxicity
study,
the
toxicology
database
for
cypermethrin
is
complete
and
there
are
no
data
gaps.
The
scientific
quality
is
relatively
high
and
the
toxicity
profile
of
cypermethrin
can
be
characterized
for
all
effects,
including
potential
developmental,
reproductive
and
neurotoxic
effects.
The
data
provided
no
indication
of
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure.
    
18
  
71
Acute
Toxicity:
Acute
toxicity
studies
conducted
with
cypermethrin
indicate
that
it
is
moderately
acutely
toxic
via
the
oral
route
(
Category
II);
however,
it
is
not
very
toxic
via
the
dermal
and
inhalation
routes
(
Categories
III
and
IV).
It
is
mildly
irritating
to
the
eyes
and
skin
and
is
a
dermal
sensitizer.

Target
Tissues,
Species/
Sex
Sensitivity,
Dose­
Response:

The
database
on
cypermethrin
indicates
one
major
target
for
this
chemical:
the
neuromuscular
system.
There
are
indications
of
effects
on
the
liver
in
mice
and
rabbits;
however,
these
effects
are
not
considered
to
be
of
major
significance.

Neurotoxic
Effects:
Cypermethrin
is
a
known
neurotoxicant.
It
is
a
member
of
the
pyrethroid
class
of
insecticides,
which
are
known
to
induce
clinical
signs
of
neurotoxicity
in
mammals,
but
do
not
generally
induce
neuropathologic
lesions.
The
neuromuscular
effects
(
i.
e.
gait
abnormalities,
tremors,
reduced
motor
activity,
and
convulsions)
occur
across
species,
sexes
and
routes
of
administration.
These
clinical
signs
appear
to
have
more
of
a
transient
nature
as
opposed
to
effects
which
appear
after
an
accumulated
exposure.
They
occur
mainly
in
oral
studies
in
the
dog
and
the
rat,
but
similar
signs
were
also
observed
in
a
rat
inhalation
study.
They
were
not
observed
in
the
dermal
studies
in
either
rats
(
zeta­
cypermethrin)
or
rabbits
(
cypermethrin:
nonabraded
animals;
abraded
animals
did
exhibit
decreases
in
activity).

The
weight
of
the
evidence
indicates
that
the
dog
is
likely
to
be
the
most
sensitive
species
for
neuromuscular
effects.

The
HIARC
previously
recommended
that
a
rat
developmental
neurotoxicity
(
DNT)
study
be
conducted
using
zeta­
cypermethrin
and
that
results
be
bridged
to
cypermethrin
for
this
risk
assessment.
The
requested
DNT
study
(
2005,
MRID
No.:
46670402)
was
submitted
and
has
now
been
reviewed.
The
results
of
this
study
were
presented
to
the
HED
DNT
Committee
on
16­
MAR­
2006.
The
Committee
determined
the
study
was
acceptable/
nonguideline
There
were
no
maternal
effects
at
the
highest
dose
tested.
The
offspring
NOAEL
and
LOAEL
were
set
at
7.4
and
17.3
mg/
kg/
day
based
on
evidence
of
reduced
body
weight
and
gain
in
female
pups
and
marginal
but
suggestive
changes
in
brain
morphometry.

Since
the
NOAEL/
LOAELs
used
in
the
current
zeta­
cypermethrin
risk
assessment
are
lower
than
or
essentially
equal
to
the
NOAEL/
LOAELs
identified
in
the
DNT
study,
they
will
continue
to
be
used
for
risk
assessment
purposes.
The
dose
currently
selected
for
acute
and
short­
term
dietary
risk
assessment
is
10
mg/
kg,
in
contrast
with
the
7.4
mg/
kg/
day
NOAEL
established
in
the
DNT
study.
However,
this
slight
difference
is
considered
an
artifact
of
dose
selection,
and,
therefore,
not
indicative
that
the
DNT
has
yielded
a
more
sensitive
endpoint
and/
or
lower
point
of
departure.
    
19
  
71
Liver:
Liver
effects
were
observed
in
the
mouse
oncogenicity
study
and
the
rabbit
dermal
study
(
abraded
animals
only).
The
effects
in
rabbits
would
be
significant,
except
that
the
Agency
does
not
generally
use
data
from
abraded
animals
in
a
dermal
toxicity
study.
The
effects
in
the
mouse
are
probably
due
to
induction
of
microsomal
enzymes
in
the
liver
and
are
probably
an
adaptive
response
as
opposed
to
a
toxicological
effect.
In
the
presence
of
a
xenobiotic,
certain
metabolic
pathways
are
stimulated
in
the
liver
to
increase
the
ability
of
the
animal
to
purge
itself
of
the
xenobiotic.
Therefore,
the
liver
effects
are
not
as
toxicologically
significant
as
the
neuromuscular
effects.

Dermal
Studies
and
Dermal
Absorption:
Two
dermal
studies
were
available,
one
on
cypermethrin
and
one
on
zeta­
cypermethrin.
No
systemic
effects
were
observed
in
the
21­
day
dermal
study
in
the
rat
conducted
with
zeta­
cypermethrin
at
dose
levels
up
to
1000
mg/
kg/
day.
Only
local
irritation
effects
were
observed
in
this
study.
The
observed
systemic
effects
in
the
21­
day
dermal
study
conducted
with
cypermethrin
in
rabbits
(
focal
necrosis
of
the
liver,
decrease
in
testicular
weights
and
body
weight
loss
(
females))
were
noted
only
in
animals
with
abraded
skin.
No
systemic
effects
were
observed
in
animals
with
nonabraded
skin
up
to
the
highest
dose
tested
(
200
mg/
kg/
day).
Again,
dermal
irritation
was
observed
in
this
study.
Both
the
dermal
irritation
and
effects
in
the
abraded
rabbits
were
discounted
for
risk
assessment
purposes.
Current
policy
states
that
dermal
irritation
is
not
generally
used
for
risk
assessment.
The
observations
in
the
abraded
rabbits
were
not
used
because
1)
the
method
does
not
simulate
actual
exposure,
2)
the
test
conditions
are
compromised,
3)
there
would
be
physiological
differences
between
the
abraded
and
nonabraded
animals
and
4)
the
rat
is
the
more
sensitive
species
for
zeta­
cypermethrin
in
the
oral
studies
(
comparison
of
maternal
toxicity
in
the
developmental
studies).

A
dermal
absorption
value
of
2.5%
has
been
estimated
by
comparing
the
maternal
LOAEL
of
25
mg/
kg/
day
from
the
developmental
study
in
the
rat
and
the
NOAEL
(
highest
dose
tested)
of
1000
mg/
kg/
day
from
the
21­
day
dermal
study
in
the
rat
(
both
conducted
with
zetacypermethrin
Since
there
was
no
common
endpoint
because
no
systemic
effects
were
observed
in
the
21­
day
dermal
study
in
the
rat,
this
is
considered
to
be
a
worst­
case
estimate.

Developmental/
Reproductive
Effects:
In
the
prenatal
developmental
toxicity
studies
in
rats
and
rabbits,
there
was
no
evidence
of
developmental
toxicity
at
the
highest
dose
tested.
Maternal
toxicity
was
observed
in
these
studies
in
the
form
of
decreased
body
weight
gain
and
food
consumption
and/
or
clinical
signs
of
neurotoxicity
such
as
gait
abnormalities.
In
the
multigeneration
reproduction
studies
in
rats,
offspring
toxicity
was
observed
at
the
same
treatment
level
which
resulted
in
parental
systemic
toxicity.
There
did
not
appear
to
be
any
increases
in
severity
of
toxicity
for
the
pups
in
these
studies.

Carcinogenicity/
Mutagenicity:
Cypermethrin
has
been
classified
as
a
Category
C,
possible
human
carcinogen,
based
on
an
increased
incidence
of
lung
adenomas
and
adenomas
plus
carcinomas
combined
in
female
mice
(
Cancer
Peer
Review
Committee,
1988).
The
evidence
was
not
considered
strong
enough
to
warrant
a
quantitative
estimation
of
human
risk.
The
endpoint
selected
for
the
chronic
population
adjusted
dose
(
cPAD)
will
    
20
  
71
be
protective
of
the
possible
carcinogenic
activity
of
this
chemical.
Cypermethrin
has
not
been
classified
under
the
more
current,
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
(
April
10,
1996).
Structure­
activity
comparisons
with
the
pyrethroid
class
of
insecticides
indicate
that
lung
tumors
in
mice
were
induced
with
3
other
pyrethroids.
Cypermethrin
was
negative
in
all
mutagenicity
studies
available
to
the
Agency.

Toxicological
Significance
of
Effects:
The
neuromuscular
effects
(
i.
e.
gait
abnormalities,
tremors,
reduced
motor
activity,
changes
in
FOB
parameters
and
convulsions)
occur
across
species,
sexes
and
routes
of
administration.
These
clinical
signs
appear
to
be
more
of
a
transient
acute
effect
as
opposed
to
an
effect
which
appears
after
an
accumulated
dose.
For
cypermethrin,
they
are
considered
to
be
the
most
significant
toxicological
effects.

Mode
of
Action:
Cypermethrin
is
a
type
II
pyrethroid
(
i.
e.
it
has
a
cyano
group
at
the
 
carbon
position
of
the
alcohol
moiety
and
it
is
more
effective
when
the
ambient
temperature
is
raised).
Ware
states,
"
pyrethroids
initially
stimulate
nerve
cells
to
produce
repetitive
discharges
and
eventually
cause
paralysis.
Such
effects
are
caused
by
their
action
on
the
sodium
channel,
a
tiny
hole
through
which
sodium
ions
are
permitted
to
enter
the
axon
to
cause
excitation.
These
effects
are
produced
in
insect
nerve
cord,
which
contains
ganglia
and
synapses,
as
well
as
in
giant
nerve
fiber
axons.
The
exact
sites
of
action
of
pyrethroids
at
synapses
are
not
known.
It
is
probable
that
the
toxic
action
of
pyrethroids
is
primarily
due
to
its
blocking
action
on
the
nerve
axon
since
this
action
shows
a
negative
temperature
coefficient.
But
because
the
cockroach
ganglion
is
affected
by
pyrethroid
concentrations
many
fold
less
than
are
required
to
block
conduction
in
giant
fibers,
its
also
seems
likely
that
pyrethroids
act
on
some
aspect
of
synaptic
function.
The
fast
knockdown
of
flying
insects
could
be
the
result
of
rapid
muscular
paralysis,
suggesting
that
the
ganglia
of
the
insect
central
nervous
system
are
affected."

3.2
FQPA
Considerations
On
January
22,
2003,
the
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
determined
that
the
special
FQPA
safety
factor
should
be
1X
since
there
are
no
residual
uncertainties
for
pre
and/
or
post
natal
toxicity.
The
data
demonstrated
no
indication
of
increased
sensitivity
or
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure.
In
the
neurotoxicity
studies,
clinical
signs
of
neurotoxicity
typical
of
pyrethroids
were
observed
(
gait
abnormalities,
decreased
motor
activity,
notable
changes
in
the
functional
observational
battery
(
FOB),
and
tremors).
No
neuropathology
was
observed.
In
the
other
guideline
studies,
tremors
and
gait
abnormalities
were
observed
in
both
dog
and
rat
oral
studies.
Similar
clinical
signs
were
also
observed
in
the
rat
inhalation
study.
Since
the
recently
submitted
DNT
study
demonstrated
increased
sensitivity
for
the
pups,
the
reduction
of
the
FQPA
safety
factor
from
10X
to
1X
as
originally
assigned
by
the
HIARC
was
reconsidered.
The
conclusion
was
that
since
the
NOAELs
used
for
risk
assessment
are
essentially
equal
to
or
lower
than
the
NOAEL
for
the
DNT
study,
the
endpoints
selected
are
already
protective
of
potential
toxicity
to
the
young.
Thus,
a
FQPA
safety
factor
of
1X
is
appropriate
for
cypermethrin.
    
21
  
71
There
are
no
residual
uncertainties
identified
in
the
exposure
databases.
The
dietary
food
exposure
assessment
includes
anticipated
residue
estimates,
PDP
data,
experimentally­
determined
cropspecific
processing
factors,
and
available
%
CT
information
from
BEAD
(
100%
CT
is
assumed
for
those
crops
where
BEAD
data
are
not
available).
Dietary
drinking
water
exposure
is
based
on
conservative
modeling
estimates.
The
residential
exposure
assessment
utilizes
residential
SOPs
for
the
adult
handler
and
post­
application
scenarios,
and
to
assess
post­
application
exposure
to
children
as
well
as
incidental
oral
ingestion
by
toddlers.
The
residential
SOPs
are
based
on
reasonable
worst­
case
assumptions
and
will
not
likely
underestimate
exposure/
risk.
These
assessments
are
unlikely
to
underestimate
the
potential
exposure
to
infants
and
children
resulting
from
the
use
of
cypermethrin.
As
a
result,
the
cypermethrin
risk
assessment
team
concludes
that
no
additional
safety
factor
is
needed
to
account
for
exposure
considerations.

3.3
Dose­
Response
Assessment
Discussion
of
Toxicological
Database
for
Risk
Assessment
Purposes:
The
toxicology
database
for
cypermethrin
is
complete
and
with
the
exception
of
a
developmental
neurotoxicity
study,
there
are
no
data
gaps.
The
scientific
quality
is
relatively
high
and
the
toxicity
profile
of
cypermethrin
can
be
characterized
for
all
effects,
including
potential
carcinogenic,
mutagenic,
developmental,
reproductive
and
neurotoxic
effects.

Acute
Dietary
Exposure:
The
hazard
endpoint
of
10
mg/
kg/
day
from
the
acute
neurotoxicity
study
in
the
rat
conducted
with
zeta­
cypermethrin
is
considered
to
be
appropriate
for
acute
dietary
exposure
for
the
general
population,
including
infants
and
children
because
it
is
based
on
clinical
signs
of
neurotoxicity
and
changes
in
FOB
parameters
(
relevant
to
pyrethroid
toxicity)
observed
after
a
single
dose
exposure.
The
LOAEL
is
50
mg/
kg/
day,
which
is
in
the
same
order
of
magnitude
as
the
NOAEL,
so
the
dose
spacing
is
not
large.
Although
the
endpoint
is
based
on
zeta­
cypermethrin,
which
may
be
slightly
more
toxic
than
cypermethrin,
it
is
not
considered
to
be
overly
conservative
because
a
literature
study
conducted
with
cypermethrin
indicated
a
NOAEL
less
than
20
mg/
kg
(
lowest
dose
tested).
A
separate
acute
dietary
endpoint
for
females
13­
50
was
not
selected
because
neither
zeta­
cypermethrin
nor
cypermethrin
induce
any
developmental
effects.

Chronic
Dietary
Exposure:
The
chronic
dietary
endpoint
is
based
on
a
NOAEL
of
6
mg/
kg/
day
from
a
chronic
feeding
study
in
the
dog
conducted
with
cypermethrin.
The
previous
chronic
dietary
endpoint
was
based
on
an
increase
in
loose
stools
in
dogs
when
administered
cypermethrin
via
capsule
in
corn
oil.
The
HIARC
determined
that
the
chronic
feeding
study
in
the
dog
is
more
appropriate
for
the
chronic
dietary
endpoint
because
dietary
exposure
is
more
relevant
for
the
expected
exposure
and
the
gastrointestinal
effects
in
the
capsule
dog
study
at
a
LOAEL
of
5
mg/
kg/
day
and
a
NOAEL
of
1
mg/
kg/
day
may
be
due
to
focal
exposure
(
bolus
dose
with
corn
oil).
In
addition,
the
endpoint
(
clinical
signs
of
neurotoxicity)
is
of
particular
relevance
to
pyrethroid
toxicity.
    
22
  
71
Short­
Term
Incidental
Oral
Exposure:
The
hazard
endpoint
of
10
mg/
kg/
day
from
the
acute
neurotoxicity
study
in
the
rat
is
considered
to
be
appropriate
for
short­
term
incidental
oral
exposure
because
it
is
based
on
clinical
signs
of
neurotoxicity
and
changes
in
FOB
parameters
(
relevant
to
pyrethroid
toxicity)
observed
after
a
single
dose
exposure.
The
LOAEL
is
50
mg/
kg/
day,
which
is
in
the
same
order
of
magnitude
as
the
NOAEL,
so
the
dose
spacing
is
not
large.
See
comments
under
acute
dietary
exposure
as
to
why
this
endpoint
is
appropriate
for
a
short­
term
oral
exposure.

Intermediate­
Term
Incidental
Oral
Exposure:
The
hazard
endpoint
of
5.0
mg/
kg/
day
from
the
subchronic
neurotoxicity
study
in
the
rat
is
considered
to
be
appropriate
for
intermediate­
term
oral
exposure
because
it
is
from
an
oral
feeding
study
of
an
appropriate
duration
of
exposure.
In
addition,
it
is
based
on
clinical
signs
typical
of
pyrethroid
toxicity:
decreased
motor
activity,
increased
landing
foot
splay,
and
decreased
body
weights,
body
weight
gains,
and
food
consumption
observed
in
males
at
26.3
mg/
kg/
day.
See
the
comments
under
the
chronic
dietary
endpoint
as
to
why
the
chronic
capsule
dog
study
was
not
selected
for
this
endpoint.
In
addition,
it
is
recognized
that
the
NOAEL
of
5.0
mg/
kg/
day
selected
for
this
endpoint
is
less
than
the
NOAEL
of
6.0
mg/
kg/
day
selected
for
the
chronic
dietary
endpoint.
This
is
due
to
dose
selection
and
spacing.
For
cypermethrin,
this
NOAEL
may
be
somewhat
conservative
because
it
is
based
on
a
NOAEL
from
a
subchronic
neurotoxicity
study
conducted
with
zeta­
cypermethrin,
which
appears
to
be
slightly
more
toxic
than
cypermethrin.

Dermal
Short­
and
Intermediate
Endpoints
:
No
hazard
has
been
identified
to
support
quantitation
of
risk.
No
systemic
effects
were
observed
in
either
a
21­
day
dermal
study
conducted
with
zeta­
cypermethrin
in
the
rat
at
dose
levels
up
to
1000
mg/
kg/
day
or
a
21­
day
dermal
study
conducted
with
cypermethrin
in
rabbits
at
dose
levels
up
to
200
mg/
kg/
day
(
there
were
systemic
effects
in
abraded
rabbits;
however,
the
current
policy
is
that
abraded
rabbits
are
not
used
for
the
purpose
of
assessment
of
risk).
In
addition,
no
developmental
effects
were
observed
in
any
of
the
available
developmental
studies.
Since
zeta­
cypermethrin
appears
to
be
slightly
more
toxic
than
cypermethrin,
the
conclusions
concerning
these
endpoints
are
appropriate
for
cypermethrin.

Long­
term
Dermal
Endpoint
:
See
the
Chronic
Dietary
Exposure
section
(
above)
for
the
discussion
on
this
endpoint
and
its
relevance
to
human
health.
This
endpoint
is
conservative
since
nothing
was
observed
in
the
21­
day
dermal
study
and
the
observed
neurotoxic
effects
are
acute,
transitory
and
tend
not
to
be
cumulative
with
longer
term
dosing.
In
addition,
the
NOAELs
and
LOAELs
from
the
90­
day
rat
and
the
chronic
rat
studies
are
identical.
This
indicates
that
the
observed
decreases
in
body
weight
and
body
weight
gain
are
also
not
cumulative
with
longer
term
dosing.

Inhalation
Endpoint
(
Any
Time
Period)
:
The
hazard
endpoint
of
0.01
mg/
L
from
the
21­
day
inhalation
study
on
cypermethrin
in
the
rat
is
considered
to
be
appropriate
for
short­
,
intermediate­
and
long­
term
exposure
because
this
study
is
the
most
appropriate
route
of
    
23
  
71
exposure
and
because
there
is
no
evidence
of
developmental
toxicity.
The
LOAEL
is
0.05
mg/
L
based
on
a
decrease
in
body
weight.
The
dose
spacing
is
not
large.
The
uncertainty
factors
(
UFs)
100
for
short­
and
intermediate­
term
exposure
and
300
for
long­
term
exposure.
Based
on
a
comparison
of
the
results
from
the
inhalation
study
and
the
oral
studies
which
provided
the
endpoints
in
the
risk
assessment,
it
appears
that
the
most
sensitive
route
of
administration
is
inhalation.
The
addition
of
a
3x
UF
for
long­
term
exposure
is
for
the
lack
of
an
alternative
study
on
which
to
make
an
endpoint
selection.
If
an
oral
study
is
used,
route­
to­
route
extrapolation
results
in
a
less
protective
endpoint.
For
example,
if
the
NOAEL
of
6
mg/
kg/
day
from
the
chronic
oral
feeding
study
in
dogs
is
used
for
the
long­
term
inhalation
endpoint,
then
the
resulting
endpoint
would
be
less
protective
than
the
0.01
mg/
L
(
2.7
mg/
kg/
day)
endpoint
provided
by
the
21­
day
inhalation
study.
Unlike
the
acute
and
transitory
neurological
effects
observed
in
the
other
studies
with
cypermethrin,
the
NOAEL
from
the
inhalation
study
is
based
on
a
mean
decrease
in
body
weight.
Although
decreases
in
body
weight
and
body
weight
gain
are
not
necessarily
transient
effects
as
are
the
clinical
signs
observed
with
this
chemical,
as
stated
in
the
longterm
dermal
section,
a
comparison
of
the
results
from
the
90­
day
and
chronic
rat
studies
indicates
that
the
observed
decreases
in
body
weight
and
body
weight
gain
are
also
not
cumulative
with
longer
term
dosing.
Therefore,
the
addition
of
a
3X
UF
for
long­
term
exposure
provides
a
very
conservative
endpoint
for
assessment
of
risk,
especially
since
it
is
already
based
on
an
inhalation
study.

Carcinogenicity:
As
stated
previously,
cypermethrin
has
been
classified
as
a
Category
C,
no
Q*,
based
on
an
increased
incidence
of
lung
adenomas
and
adenomas
plus
carcinomas
combined
in
female
mice.
The
evidence
was
not
considered
strong
enough
to
warrant
a
quantitative
estimation
of
human
risk.
The
endpoint
selected
for
the
chronic
population
adjusted
dose
(
cPAD)
will
be
protective
of
any
possible
carcinogenic
activity
from
exposure
to
this
chemical.
    
24
  
71
Table
3.
Summary
of
Toxicological
Dose
and
Endpoints
for
Cypermethrin
for
Use
in
Human
Risk
Assessment
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effectsa
Acute
Dietary
general
population
including
infants
and
children
NOAEL
=
10
mg
a.
i./
kg
UF
=
100
Acute
RfD
=
0.1
mg/
kg
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.1
mg/
kg
Acute
neurotoxicity
study
in
the
rat
(
zeta­
cypermethrin).
LOAEL
=
50
mg/
kg
based
on
clinical
signs
of
toxicity
and
FOB
findings.

Chronic
Dietary
all
populations
NOAEL=
6
mg
a.
i./
kg/
day
UF
=
100
Chronic
RfD
=
0.06
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
0.06
mg/
kg/
day
Chronic
feeding
study
in
the
dog.

LOAEL
=
20.4/
18.1
mg/
kg/
day
based
on
clinical
signs
of
neurotoxicity
and
mortality
in
males,
and
decreased
body
weights
and
body
weight
gains
in
females.

Short­
Term
Incidental
Oral
(
1
to
30
days)
NOAEL=
10
mg
a.
i./
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
N/
A
Acute
neurotoxicity
study
in
the
rat
(
zeta­
cypermethrin).
LOAEL
=
50
mg/
kg/
day
based
on
clinical
signs
of
neurotoxicity
and
changes
in
the
FOB
Intermediate­
Term
Incidental
Oral
(
1
­
6
months)
NOAEL=
5.0
mg
a.
i./
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
N/
A
Subchronic
neurotoxicity
study
in
the
rat
(
zeta­
cypermethrin).
LOAEL
=
26.3
mg/
kg/
day
based
on
decreased
motor
activity,
increased
landing
foot
splay,
and
decreased
body
weights,
body
weight
gains,
and
food
consumption
Short­
and
Intermediate­
Term
Dermal
(
1
day
to
6
months
None
Residential
LOC
for
MOE
=
N/
A
Occupational
LOC
for
MOE
=
N/
A
No
systemic
effects
in
21­
day
dermal
study
(
zeta­
cypermethrin)
up
to
1000
mg/
kg/
day&
no
developmental
concern.
No
hazard
identified
to
support
quantitation
of
risk.

Long­
Term
Dermal
(>
6
months)
Oral
NOAEL=
6
mg
a.
i./
kg/
day
(
dermal
absorption
factor
=
2.5%)
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
100
Chronic
feeding
study
in
the
dog.
LOAEL
=
20.4/
18.1
mg/
kg/
day
based
on
clinical
signs
of
neurotoxicity
and
mortality
in
males,
and
decreased
body
weights
and
body
weight
gains
in
females.

Short­
and
Intermediate­
Term
Inhalation
(
1
day
to
Inhalation
NOAEL=
0.01
mg
a.
i./
L/
day
(
2.7
Residential
LOC
for
MOE
=
100
21­
day
inhalation
study
in
the
rat.
LOAEL
=
0.05
mg/
L/
day
(
13.5
mg/
kg/
day)
based
on
decrease
in
    
25
  
71
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effectsa
6
months)
mg/
kg/
day)

Occupational
LOC
for
MOE
=
100
body
weight
and
salivation.

Long­
Term
Inhalation
(>
6
months)
Inhalation
NOAEL=
0.01
mg
a.
i./
L
(
2.7
mg/
kg/
day)
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
300
for
the
lack
of
a
6­
month
study.
Route­
toroute
estimation
would
result
in
less
protective
endpoint.
21­
day
inhalation
study
in
the
rat.
LOAEL
=
0.05
mg/
L/
day
(
13.5
mg/
kg/
day)
based
on
decrease
in
body
weight
and
salivation.

Cancer
(
oral,
dermal,
inhalation)
Classification:
Category
C
(
possible
human
carcinogen).
No
quantitation
required.

UF
=
uncertainty
factor,
FQPA
SF
=
Special
FQPA
safety
factor,
NOAEL
=
no
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c=
chronic),
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern,
N/
A
=
not
applicable
a
Endpoints
selected
from
studies
conducted
with
cypermethrin
unless
specified
otherwise.

As
per
FQPA,
1996,
when
there
are
potential
residential
exposures
to
the
pesticide,
aggregate
risk
assessment
must
consider
exposures
from
three
major
sources:
oral,
dermal
and
inhalation
exposures.
The
toxicity
endpoints
selected
for
these
routes
of
exposure
may
be
aggregated
as
follows.
For
the
acute
and
chronic
dietary
aggregate
risks,
the
recommendation
is
food
plus
water.
For
short­
term
aggregate
risk,
the
recommendation
is
food
plus
water,
incidental
oral,
and
inhalation
(
dermal
is
not
required
for
these
scenarios).
Intermediate­
and
long­
term
residential
exposures
are
not
anticipated.

3.4
Endocrine
Disruption
EPA
is
required
under
the
Federal
Food
Drug
and
Cosmetic
Act
(
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
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
were
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC s
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
    
26
  
71
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

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

4.0
EXPOSURE
ASSESSMENT
4.1
Summary
of
Registered
Uses
Table
4.1.1
provides
a
summary
of
the
directions
for
use
of
cypermethrin.
Cypermethrin
is
an
insecticide
used
on
agricultural
crops
and
animals,
residential
and
commercial
lawns,
and
in
and
around
industrial,
commercial,
and
residential
premises.
Cypermethrin
formulations
include
liquid
and
wettable
powders
concentrates,
ready­
to­
use
aerosols,
foggers,
trigger­
pump
sprayers,
impregnated
wipes
and
eartags.
Cypermethrin
can
be
used
by
homeowners
on
pet
horses
and
in
and
around
residential
premises.
Applications
to
agricultural
crops
can
be
made
with
aircraft,
chemigation,
groundboom,
and
airblast
equipment.
Applications
at
industrial,
commercial,
and
residential
sites
can
be
made
using
handheld
equipment
such
as
low­
pressure
handwand
sprayers,
backpack
sprayers,
hose­
end
sprayers,
handgun
sprayers,
paintbrushes,
and
termiticide
injectors,
in
addition
to
ready­
to­
use
(
RTU)
aerosol
cans,
indoor
foggers,
pump­
trigger
sprayers,
impregnated
wipes
and
eartags.
There
are
no
home
owner
use
associated
with
zeta­
cypermethrin
products.

For
the
purposes
of
reregistration,
label
amendments
are
needed
for
cypermethrin
EPs
with
use
claims
on
garlic,
lettuce,
onions,
and
pecans
to
specify
minimum
retreatment
intervals.
In
addition,
several
product
labels
allow
application
in
less
than
2
gal/
A
when
using
aerial
equipment.
Unless
the
registrants
submit
field
residue
data
to
support
aerial
applications
in
<
2
gal/
A,
the
product
labels
should
be
amended
to
specify
that
aerial
applications
be
made
in
a
minimum
of
2
gal/
A.
The
feeding/
grazing
restriction
for
cotton
forage
is
not
practical
and
should
be
removed
from
the
label.
    
27
  
71
Table
4.1.1.
Summary
of
Directions
for
Use
of
Cypermethrin.

Site
Application
Type
Application
Timing
Application
Equipment
Maximum
Single
Appl.

Rate
(
ai)
Maximum
Number
of
Applications
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
1
Cotton
Foliar
broadcast
application
Ground,
sprinkler
irrigation,

or
aerial
equipment
0.1
lb/
A
NS
3
(
for
boll
weevil
control)
Applications
may
be
made
in
water
or
refined
vegetable
oil.
When
using
water,

applications
may
be
made
in
a
minimum
of
5
gal
of
finished
spray/
A
using
ground
equipment
or
1
gal
of
finished
spray/
A
using
aerial
equipment.
One
quart
of
emulsified
oil
(
minimum)
may
be
substituted
for
one
quart
of
water
in
aerial
applications.
When
using
oil,
applications
may
be
made
in
a
minimum
of
1
qt/
A
in
the
finished
spray.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
products
approved
for
use
on
cotton.
The
grazing
or
feeding
of
cotton
forage
is
prohibited.
A
14­
day
PHI
and
a
12­
hour
REI
have
been
established.
A
maximum
seasonal
rate
of
0.6
lb
ai/
A
is
in
effect.

Head
and
stem
Brassica
sub
group
Foliar
broadcast
application
Ground
or
aerial
equipment
0.1
lb/
A
NS
7
Applications
may
be
made
in
a
minimum
of
15
gal/
A
using
ground
equipment
or
5
gal/
A
using
aerial
equipment.
A
1­
day
PHI
and
a
12­
hour
REI
have
been
established.
A
maximum
seasonal
rate
of
0.6
lb
ai/
A
is
in
effect.

Leafy
Brassica
Greens
sub
group
Foliar
broadcast
application
Ground
or
aerial
equipment
0.1
lb/
A
NS
7
Applications
may
be
made
in
a
minimum
of
15
gal/
A
using
ground
equipment
or
5
gal/
A
using
aerial
equipment.
A
1­
day
PHI
and
a
12­
hour
REI
have
been
established.
A
maximum
seasonal
rate
of
0.4
lb
ai/
A
is
in
effect.

Lettuce,
head
Foliar
broadcast
application
Ground
or
aerial
equipment
0.1
lb/
A
NS
NS
Applications
may
be
made
in
a
minimum
of
15
gal/
A
using
ground
equipment
or
5
gal/
A
using
aerial
equipment.
A
5­
day
PHI
and
a
12­
hour
REI
have
been
established.
A
maximum
seasonal
rate
of
0.6
lb
ai/
A
is
in
effect.
    
28
  
71
Site
Application
Type
Application
Timing
Application
Equipment
Maximum
Single
Appl.

Rate
(
ai)
Maximum
Number
of
Applications
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
1
Onion,
bulb&
green
(
including
garlic
and
shallots)

Foliar
broadcast
application
Ground
or
aerial
equipment
0.1
lb/
A
NS
NS
Applications
may
be
made
in
a
minimum
of
20
gal/
A
using
ground
equipment
or
3
gal/
A
using
aerial
equipment.
The
grazing
of
livestock
in
treated
areas
or
cutting
of
treated
crops
for
feed
is
prohibited.
A
7­
day
PHI
and
a
12­
hour
REI
have
been
established.
A
maximum
seasonal
rate
of
0.5
lb
ai/
A
is
in
effect.

Pecans
Foliar
broadcast
application
Pre­
shuck
split
Ground
equipment
0.1
lb/
A
NS
NS
Ground
applications
may
be
made
to
the
point
of
drip;
100
gal/
A
for
smaller
trees
and
200
to
300
gal/
A
for
larger
trees.
The
grazing
of
livestock
in
treated
orchards
or
cutting
of
treated
cover
crops
for
feed
is
prohibited.
A
21­
day
PHI
has
been
established.
A
maximum
seasonal
rate
of
0.6
lb
ai/
A
is
in
effect;

for
SLN
No.
NM860002,
a
maximum
seasonal
rate
of
0.8
lb
ai/
A
is
in
effect.

Food­
Handling
Establishments
Spot
or
crack/
crevice
application
Brush
or
spray
equipment
0.2%
NS
Not
applicable
(
NA)
Application
is
allowed
in
non­
food
areas
of
food­
handling
establishments
(
other
than
private
residences)
in
which
food
is
held,
processed,
prepared
or
served.

Use
in
food
areas
of
food
handling
establishments,
restaurants
or
other
areas
where
food
is
commercially
prepared
is
prohibited.
The
label
prohibits
use
in
serving
areas
while
food
is
exposed
or
facility
is
in
operation.
The
label
specifies
that
in
the
home
all
food
processing
surfaces
and
utensils
should
be
covered
during
treatment
or
thoroughly
washed
before
use;
exposed
food
should
be
covered
or
removed.

Application
in
warehouses
where
raw
or
cured
tobacco
is
stored,
or
while
raw
agricultural
commodities
for
food
or
feed
are
being
stored
is
prohibited.

Applications
may
be
repeated
as
necessary.

Spot
or
crack/
crevice
application
0.1%
NS
NA
Applications
may
be
repeated
as
necessary.
    
29
  
71
Site
Application
Type
Application
Timing
Application
Equipment
Maximum
Single
Appl.

Rate
(
ai)
Maximum
Number
of
Applications
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
1
Brush
or
spray
equipment
4.2
Dietary
Exposure/
Risk
Pathway
4.2.1
Residue
Profile
Nature
of
the
Residue
in
Plants:
The
Metabolism
Assessment
Review
Committee
(
MARC)
determined
that
the
residue
of
concern
for
enforcement
and
dietary
risk
assessment
purposes
is
cypermethrin
per
se
in
plants,
livestock,
and
drinking
water
(
D219212,
J.
Morales,
14­

SEP­
1995).
Thus,
the
current
tolerance
expression
for
plants
is
adequate.
Also,
the
MARC
determined
(
D269584,
Y.
Donovan,
03­
NOV­

2000)
that
residues
of
the
metabolite
dichlorovinyl
acid
(
DCVA)
(
cis
and
trans)
need
not
be
included
in
the
tolerance
expression
or
risk
assessment
for
cypermethrin
and
zeta­
cypermethrin.
This
determination
was
based
on
the
observation
that
in
the
majority
of
crops,
parent
compound
accounts
for
at
least
90%
of
the
total
residue.
In
those
crops
where
DCVA
was
found
>
10%,
either
the
detected
DCVA
levels
were
below
the
LOQ
or
the
maximum
animal
dietary
burden
contributions
from
DCVA
for
these
commodities
were
about
equal
to
or
less
than
the
LOQ.
Regulation
of
the
parent
only
is
consistent
with
CODEX
and
facilitates
enforcement,
since
DCVA
is
not
recovered
by
the
multi­
residue
enforcement
methods.

Nature
of
the
Residue
in
Livestock:
The
qualitative
nature
of
the
residue
in
ruminants
and
poultry
is
adequately
understood.
The
HED
MARC
has
determined
that
the
residue
to
be
regulated
in
livestock
commodities
is
cypermethrin
per
se;
thus,
the
current
tolerance
expression
for
livestock
commodities
is
appropriate.

Residue
Analytical
Methods
­
Plants
and
Livestock:
No
additional
information
regarding
residue
analytical
methods
is
required.

The
Pesticide
Analytical
Manual
(
PAM)
Volume
II
lists
Methods
I
and
II
as
available
for
the
determination
of
residues
of
cypermethrin
per
se
in/
on
plant
and
livestock
commodities,
respectively.
Both
are
GLC
methods
with
electron
capture
detection
and
have
undergone
successful
Agency
method
tryout.
Method
I
has
a
detection
limit
of
0.01
ppm,
and
Method
II
has
detection
    
30
  
71
limits
of
0.005
ppm
for
milk
and
0.01
ppm
for
livestock
tissues.
These
methods
are
not
stereospecific;
thus
no
distinction
is
made
between
residues
of
cypermethrin
(
all
eight
stereoisomers)
and
zeta­
cypermethrin
(
an
enriched
enantiomer
form
of
cypermethrin).

Revised
versions
of
the
livestock
methods
which
are
capable
of
determining
cypermethrin
and
DCVA
were
recently
validated
by
an
independent
laboratory.
Adequate
recoveries
were
obtained
by
the
laboratory.
The
revised
methods
were
also
subjected
to
a
successful
radiovalidation.
Methods
for
determination
of
DCVA
are
available
in
PAM
Volume
II
in
the
section
for
permethrin.

Multiresidue
Methods:
The
1/
94
FDA
PESTDATA
database
indicates
that
residues
of
cypermethrin
are
completely
recovered
(>
80%)
using
multiresidue
method
Sections
302
(
Luke),
303
(
Mills,
Onley,
and
Gaither)
and
304
(
Mills
fatty
food).
Although
the
DCVA
metabolites
have
not
been
tested
through
FDA
multiresidue
methods,
the
recovery
of
these
metabolites
has
been
shown
to
be
unlikely.
    
31
  
71
Crop
Field
Trials:
The
reregistration
requirements
for
magnitude
of
the
residue
in
plants
have
been
evaluated
and
deemed
fulfilled
for
the
following
raw
agricultural
commodities
(
RACs):
bulb
and
green
onions,
head
lettuce,
head
and
stem
Brassica
vegetables,
leafy
Brassica
vegetables,
pecans,
and
cottonseed.
Overall,
acceptable
field
trials
were
performed
representing
the
maximum
registered
use
patterns
and
conditions
under
which
the
pesticide
could
be
applied.
The
geographic
representation
for
each
commodity
is
generally
adequate,
and
a
sufficient
number
of
trials
reflecting
representative
formulation
classes
were
conducted.

Cypermethrin
is
currently
registered
for
use
on
garlic
and
shallots.
The
existing
tolerances
for
residues
in/
on
bulb
onions
and
green
onions
will
cover
the
registered
uses
of
cypermethrin
on
garlic
and
shallots,
respectively,
as
permitted
according
to
40
CFR
§
180.1(
h).

In
the
Phase
2
cypermethrin
risk
assessment,
residue
data
for
cotton
gin
byproducts
was
identified
as
a
data
gap.
These
data
were
recently
submitted
and
are
adequate
to
support
a
tolerance
level
of
11
ppm
for
this
commodity.
Although
cotton
gin
byproducts
are
a
livestock
feed
item,
inclusion
in
the
dietary
burden
does
not
increase
the
maximum
theoretical
dietary
burden
previously
computed
and
thus
no
change
in
tolerance
levels
for
livestock
commodities
are
needed.

Processed
Food/
Feed:
The
reregistration
requirements
for
magnitude
of
the
residue
in
the
processed
food/
feed
commodities
of
cottonseed
are
fulfilled.
An
acceptable
cottonseed
processing
study
has
been
submitted
and
evaluated.
The
data
from
this
processing
study
indicate
that
residues
of
cypermethrin
per
se
do
not
concentrate
in
cottonseed
meal,
hulls,
and
refined
oil
processed
from
cottonseed
bearing
detectable
residues.
Therefore,
no
separate
tolerances
are
required
for
residues
in
cotton
processed
fractions
as
the
existing
tolerance
on
cottonseed
will
cover
any
residues
in
processed
fractions
of
cotton.

Food
Handling:
Several
cypermethrin
formulations
remain
registered
for
use
in
nonfood
feed
areas
of
food­
handling
establishments
and
warehouses.
Sufficient
restrictions
are
included
on
the
basic
producer
labels
so
that
exposure
to
food
and
feed
is
unlikely.
No
additional
data
are
required
to
support
the
existing
use
in
non­
food/
feed
areas
of
food
handling
establishments.

Meat/
Milk/
Poultry/
Eggs:
Ruminants
Residues
of
cypermethrin
can
occur
directly
and
indirectly
in
milk
and
livestock
tissues
as
a
result
of
the
registered
uses
of
the
pesticide.
Cypermethrin
is
presently
registered
for
direct
livestock
treatments
such
as
cattle
ear
tag
uses.
Residues
of
cypermethrin
may
also
occur
indirectly
in
milk
and
livestock
tissues
due
to
registered
uses
on
agricultural
crops,
some
of
which
may
be
used
as
livestock
feed
items.
Because
the
analytical
method
does
not
distinguish
between
residues
of
cypermethrin
and
zeta­
cypermethrin,
tolerance
levels
for
MMPE
commodities
    
32
  
71
should
be
the
same
for
cypermethrin
and
zeta­
cypermethrin.
In
light
of
label
restrictions
and
the
different
total
application
rates
between
formulations
containing
cypermethrin
and
zetacypermethrin
different
tolerance
levels
may
be
appropriate
for
some
plants,
such
as
green
onions.

The
available
ruminant
magnitude
of
residue
study
has
been
evaluated
and
found
to
be
adequate
to
satisfy
ruminant
feeding
study
data
requirements.
In
this
study,
one
group
of
Holstein
dairy
cows
was
fitted
with
eartags
containing
cypermethrin
(
7%
by
weight)
and
received
gelatin
capsules
without
cypermethrin.
Three
other
groups
were
fitted
with
eartags
containing
cypermethrin
and
orally
dosed
with
cypermethrin
in
gelatin
capsules
equivalent
to
5,
15,
and
50
ppm
in
the
diet
for
28
consecutive
days
equivalent
to
~
0.28x,
0.83x,
and
2.8x
the
maximum
dietary
burden
for
cattle
(
18.1
ppm).

Based
on
a
dietary
burden
of
18.1
ppm
and
the
results
of
the
bovine
feeding
study,
the
maximum
theoretical
levels
of
cypermethrin/
zeta­
cypermethrin
in/
on
beef
muscle,
fat,
kidney,
and
milk
are
0.083,
0.55,
0.017,
and
0.049
ppm,
respectively.
Thus,
the
appropriate
tolerance
levels
for
meat,
fat,
meat
byproducts
(
of
cattle,
goat,
sheep,
and
horse)
and
whole
milk
are
0.20,
1.0,
0.05,
and
0.10
ppm,
respectively.
The
current
milk
tolerance
for
zeta­
cypermethrin
is
expressed
as
follows:
"
Milk,
fat
(
reflecting
0.10
in
whole
milk)"
at
2.5
ppm.
This
expression
accounts
for
the
concentration
of
residues
in
milk
fat
and
is
also
appropriate
for
cypermethrin.
Note
that
although
a
tolerance
level
of
0.10
ppm
could
be
selected
for
meat,
a
level
of
0.20
ppm
is
chosen
to
achieve
harmony
with
the
Codex
MRL
and
the
established
meat
tolerance
level
for
zeta­
cypermethrin.

Poultry
and
Swine
Based
on
a
dietary
burden
of
1.8
ppm
and
the
results
of
the
bovine
feeding
study,
the
maximum
theoretical
levels
of
cypermethrin/
zeta­
cypermethrin
in/
on
hog
muscle,
fat,
and
kidney
are
an
order
of
magnitude
less
than
those
for
cattle:
0.0083,
0.055,
and
0.0017
ppm,
respectively.
Because
the
LOQ
of
the
analytical
method
for
livestock
commodities
is
0.05
ppm,
the
appropriate
tolerance
levels
for
hog
meat
and
fat
are
0.05
and
0.10
ppm,
respectively.
No
tolerance
is
needed
for
hog,
meat
byproducts
due
to
the
low
levels
predicted
for
kidney
and
liver.
The
"
hog,
meat
byproducts"
tolerance
of
0.05
ppm
for
zeta­
cypermethin
should
be
removed.

The
available
poultry
feeding
study
is
adequate
to
satisfy
poultry
feeding
study
data
requirements.
In
the
poultry
feeding
study,
three
groups
of
hens
were
dosed
orally
for
28
consecutive
days
with
cypermethrin
at
2,
6,
and
20
ppm
in
the
diet,
equivalent
to
1.4x,
4.3x,
and
14.3x
the
calculated
dietary
burden
(
1.4
ppm)
for
poultry.
After
Day
7,
cypermethrin
residues
in
whole
eggs
plateaued
at
<
0.005
ppm
(
nondetectable),
0.009
ppm,
and
0.026
ppm
for
the
three
respective
treatment
groups.

Based
on
a
dietary
burden
of
1.4
ppm
and
the
results
of
the
poultry
feeding
study,
the
maximum
theoretical
levels
of
cypermethrin/
zeta­
cypermethrin
in/
on
poultry
muscle,
fat,
meat
byproducts
(
liver
and
kidney),
and
egg
are
<
0.0007,
0.020,
<
0.0007,
and
0.0086
ppm,
    
33
  
71
respectively.
Based
on
this
analysis,
no
tolerances
are
needed
for
poultry
meat
or
meat
byproducts.
However,
a
tolerance
level
of
0.05
ppm
is
appropriate
for
egg
and
poultry,
fat.
Although
the
present
analysis
suggest
that
no
tolerance
is
needed
for
poultry
meat,
setting
a
level
of
0.05
ppm
for
this
commodity
would
maintain
harmony
with
the
Codex
MRL
and
the
zeta­
cypermethrin
tolerance
listing.
The
"
poultry,
meat
byproducts"
tolerance
of
0.05
ppm
for
zeta­
cypermethin
should
be
revoked.

Water,
Fish,
and
Irrigated
Crops:
Cypermethrin
is
presently
not
registered
for
direct
use
on
potable
water
or
aquatic
food
and
feed
crops;
therefore,
no
residue
chemistry
data
are
required
under
these
guideline
topics.

Confined/
Field
Accumulation
in
Rotational
Crops:
An
acceptable
confined
rotational
study
has
been
submitted
(
MRID
00090064).
A
limited
field
rotational
crop
study
(
MRID
00098000)
has
been
submitted
and
deemed
adequate
by
EFED
to
fulfill
data
requirements
for
topic
OPPTS.
GLN
860.1900,
but
had
been
found
unacceptable
in
the
Phase
IV
review
because
the
soil
had
not
been
analyzed
for
cypermethrin.
The
most
recent
guidance
does
not
require
soil
analysis,
so
HED
considers
the
study
acceptable.
The
study
indicates
that
residues
of
cypermethrin
and
its
metabolites
were
non­
detectable
(<
0.01
ppm)
in/
on
the
rotational
crop
commodities
of
leafy
vegetables,
root
and
tuber
vegetables,
and
cereal
grain
crops
that
were
planted
30
days
after
the
soil
plots
were
treated
with
cypermethrin
at
0.5
lb
ai/
A
(~
5x
the
maximum
registered
single
application
rate).
The
submitted
study
supports
the
labelled
PBI
of
30
days
and
no
additional
rotational
crop
data
are
required
for
cypermethrin.

4.2.2
Acute
Dietary
Table
4.2.2.1.
Results
of
Acute
Dietary
Exposure
Analysis
of
Cypermethrin/
zeta­
Cypermethrin
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
da
y)
Exposure
(
mg/
kg/
day
)
%
aPAD
Exposure
(
mg/
kg/
day
)
%
aPAD
Exposure
(
mg/
kg/
da
y)
%
aPAD
General
U.
S.
Population
0.1
0.000322
0.32
0.000856
0.86
0.002600
2.6
All
Infants
(<
1
year
old)
0.1
0.000431
0.43
0.000990
0.99
0.005644
5.6
Children
1­
2
years
old
0.1
0.001179
1.2
0.003141
3.1
0.006084
6.1
Children
3­
5
years
old
0.1
0.000896
0.90
0.001924
1.9
0.003687
3.7
Children
6­
12
years
old
0.1
0.000554
0.55
0.001249
1.2
0.002293
2.3
Youth
13­
19
years
old
0.1
0.000313
0.31
0.000705
0.71
0.001675
1.7
Adults
20­
49
years
old
0.1
0.000258
0.26
0.000536
0.54
0.001383
1.4
    
34
  
71
Table
4.2.2.1.
Results
of
Acute
Dietary
Exposure
Analysis
of
Cypermethrin/
zeta­
Cypermethrin
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
da
y)
Exposure
(
mg/
kg/
day
)
%
aPAD
Exposure
(
mg/
kg/
day
)
%
aPAD
Exposure
(
mg/
kg/
da
y)
%
aPAD
Females
13­
49
years
old
0.1
0.000243
0.24
0.000535
0.54
0.001415
1.4
Adults
50+
years
old
0.1
0.000226
0.23
0.000471
0.47
0.001397
1.4
A
refined
acute
(
probabilistic)
dietary
exposure
assessment
was
performed
in
order
to
determine
the
exposure
and
risk
estimates
which
result
from
the
use
of
cypermethrin
and
zeta­
cypermethrin
in/
on
all
registered
crops.
The
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
Anticipated
residues
from
USDA
PDP
monitoring
data
(
collected
during
1994,
1996,
1999,
and
2001),
estimated
percent
crop
treated
information,
and
processing
factors,
where
available,
were
used
(
D293419,
W.
Donovan,
16­
NOV­
2005).
The
exposure
values
listed
in
Table
4.2.2.1
were
taken
directly
from
the
cypermethrin/
zeta­
cypermethrin
dietary
exposure
memo.
However,
the
aPAD
and
%
aPAD
values
have
been
adjusted
to
reflect
the
reduction
of
the
10X
database
uncertainty
factor
to
1X,
based
on
review
of
the
zeta­
cypermethrin
DNT
study.

For
all
commodities,
the
acute
risk
estimates
are
below
the
Agency s
level
of
concern
(
100%
of
the
aPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
was
children
1­
2
years
old
at
6.1%
of
the
aPAD
at
the
99.9th
percentile
of
exposure.

4.2.3
Chronic
Dietary
Table
4.2.3.1.
Results
of
Revised
Chronic
Dietary
Exposure
Analysis
for
Cypermethrin/
zeta­
Cypermethrin
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.06
0.000043
0.07
All
Infants
(<
1
year
old)
0.06
0.000049
0.08
Children
1­
2
years
old
0.06
0.000095
0.16
Children
3­
5
years
old
0.06
0.000083
0.14
Children
6­
12
years
old
0.06
0.000057
0.09
    
35
  
71
Table
4.2.3.1.
Results
of
Revised
Chronic
Dietary
Exposure
Analysis
for
Cypermethrin/
zeta­
Cypermethrin
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
Youth
13­
19
years
old
0.06
0.000038
0.06
Adults
20­
49
years
old
0.06
0.000037
0.06
Females
13­
49
years
old
0.06
0.000035
0.06
Adults
50+
years
old
0.06
0.000034
0.06
A
refined
chronic
dietary
exposure
assessment
was
performed
in
order
to
determine
the
exposure
and
risk
estimates
which
result
from
the
use
of
cypermethrin
and
zeta­
cypermethrin
in/
on
all
registered
crops.
The
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
Anticipated
residues
from
USDA
PDP
monitoring
data
(
collected
during
1994,
1996,
1999,
and
2001),
estimated
percent
crop
treated
information,
and
processing
factors,
where
available,
were
used
(
D293419,
W.
Donovan,
16­
NOV­
2005).
The
exposure
values
listed
in
Table
4.2.3.1
were
taken
directly
from
the
cypermethrin/
zeta­
cypermethrin
dietary
exposure
memo.
However,
the
cPAD
and
%
cPAD
values
have
been
adjusted
to
reflect
the
reduction
of
the
10X
database
uncertainty
factor
to
1X,
based
on
review
of
the
zeta­
cypermethrin
DNT
study.

For
all
commodities,
the
chronic
risk
estimates
are
below
the
Agency s
level
of
concern
(
100%
of
the
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
was
children
1­
2
years
old
at
0.2%
of
the
cPAD.

4.2.4
Cancer
Dietary
Cypermethrin
has
been
classified
as
a
Category
C,
possible
human
carcinogen,
based
on
an
increased
incidence
of
lung
adenomas
and
adenomas
plus
carcinomas
combined
in
female
mice
(
Cancer
Peer
Review
Committee,
1988).
The
evidence
was
not
considered
strong
enough
to
warrant
a
quantitative
estimation
of
human
risk.
The
endpoint
selected
for
the
chronic
population
adjusted
dose
(
cPAD)
will
be
protective
of
the
possible
carcinogenic
activity
of
this
chemical.
Structure­
activity
comparisons
with
the
pyrethroid
class
of
insecticides
indicate
that
lung
tumors
in
mice
were
induced
with
3
other
pyrethroids.

4.3
Water
Exposure/
Risk
Pathway
The
Environmental
Fate
and
Effects
Division
(
EFED)
(
D289428,
J.
Melendez,
5/
2/
05)
provided
estimated
environmental
concentrations
(
EECs)
of
cypermethrin
for
use
in
the
    
36
  
71
human
health
risk
assessment.
The
Metabolism
Assessment
Review
Committee
(
MARC)
concluded
that,
for
the
case
of
cypermethrin
and
zeta­
cypermethrin
only,
the
parent
compound
is
the
only
residue
of
concern
which
needs
to
be
included
in
the
tolerance
expression
and
used
for
dietary
risk
assessment,
including
drinking
water
(
D269584,
Y.
Donovan,
11/
03/
2000).

Based
on
the
available
data,
cypermethrin
and
zeta­
cypermethrin
are
moderately
persistent
chemicals
that
primarily
degrade
by
photolysis
in
water
and
biodegradation.
Cypermethrin
is
hydrologically
stable
at
neutral
pH.
Depending
on
the
environmental
circumstances,
it
may
persist
for
months
after
application.
Cypermethrin
is
tightly
bound
to
soil
particles
and
is
not
likely
to
move
to
groundwater.
DCVA
is
a
hydrolysis
product
of
several
pyrethroids
(
permethrin,
cypermethrin,
zeta­
cypermethrin,
and
cyfluthrin).
Although
it
is
significantly
more
mobile
than
the
parent
pyrethroids,
HED
has
concluded
it
does
not
need
to
be
included
in
drinking
water
assessments
for
the
following
reasons:

1)
Based
on
its
structure
(
i.
e.,
lacking
the
ester
function
in
the
parent
insecticides),
it
would
be
devoid
of
the
neurotoxic
properties
of
the
parent
and
thus,
it
would
not
be
of
significant
concern
with
respect
to
the
neurotoxicity
endpoints
on
which
the
dietary
risks
of
the
pyrethroids
are
assessed.
2)
Any
potential
toxicity
concerns
for
DCVA
will
be
mitigated
by
the
expected
low
levels
in
water,
its
high
polarity,
and
the
likelihood
of
being
readily
excreted
from
the
body
due
to
the
presence
of
the
carboxylic
acid
group.

EECs
for
cypermethrin
were
obtained
using
PRZM/
EXAMS
(
surface
water)
and
SCIGROW
(
ground
water).
All
modeling
results
discussed
here
were
based
on
6
aerial
applications
of
0.10
lb
a.
i./
A
cypermethrin
to
Brassica
leafy
vegetables
with
a
RTI
of
7
days.
For
surface
water,
the
acute
(
peak)
value
is
1.04
ppb
and
the
annual
average
value
is
0.013
ppb.
The
groundwater
screening
concentration
is
0.0036
ppb.
These
values
generally
represent
upper­
bound
estimates
of
the
concentrations
that
might
be
found
in
surface
water
and
groundwater
due
to
the
use
of
cypermethrin
on
Brassica
leafy
vegetables,
which
has
the
highest
application
rate
among
both
cypermethrin
and
zeta­
cypermethrin
on
all
crops
over
which
the
chemicals
are
applied.

4.4
Residential
Exposure/
Risk
Pathway
Handlers
Exposure
There
is
a
potential
for
exposure
in
residential
settings
during
the
application
process
for
homeowners
who
use
products
containing
cypermethrin.
There
is
also
a
potential
for
exposure
from
entering
areas
treated
with
cypermethrin,
such
as
animals,
animal
premises,
and
inside
homes
that
could
lead
to
exposures
for
adults
and
children.
As
a
result,
risk
assessments
have
been
completed
for
both
residential
handler
and
postapplication
scenarios.

Exposure
to
handlers
is
likely
during
the
residential
use
of
cypermethrin
in
many
ways
including
on
animals,
animal
premises,
and
treatments
in
and
around
homes.
The
anticipated
use
patterns
and
current
labeling
indicate
several
major
residential
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
to
make
cypermethrin
applications.
The
quantitative
    
37
  
71
exposure/
risk
assessment
developed
for
residential
handlers
is
based
on
these
scenarios.

(
1)
Mixing/
Loading/
Applying
Liquid
concentrates
with
Low
Pressure
Handwand
(
2)
Mixing/
Loading/
Applying
Liquid
concentrates
with
Wipes
(
3)
Applying
Ready
to
Use
Formulations
with
a
Pump
Sprayer
(
PHED
aerosol
can
data)
(
4)
Applying
Ready
to
Use
Formulations
with
Aerosol
Cans
(
5)
Applying
Ready
to
Use
Formulations
with
Fogger
(
6)
Applying
Ready
to
Use
Formulations
with
Wipes
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
residential
handler
risk
assessments.
Each
assumption
and
factor
is
detailed
below.
In
addition
to
these
factors,
unit
exposure
values
were
used
to
calculate
risk
estimates.
These
unit
exposure
values
were
taken
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
or
from
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
data.

Assumptions
and
Factors:
Exposure
factors
used
to
calculate
daily
exposures
to
handlers
were
based
on
applicable
data
if
available.
For
lack
of
appropriate
data,
values
from
a
scenario
deemed
similar
enough
by
the
assessor
might
be
used.
In
this
assessment
PHED
mixer/
loader/
applicator
data
for
aerosol
can
application
is
used
to
assess
indoor
fogger
applications
and
pump­
trigger
sprayer
applications.
The
nature
of
these
application
methods
are
believed
to
be
similar
enough
to
bridge
the
data.

 
The
Agency
always
considers
the
maximum
application
rates
allowed
by
labels
in
its
risk
assessments
to
consider
what
is
legally
possible
based
on
the
label.

 
Residential
risk
assessments
were
not
based
on
what
could
be
applied
in
a
typical
workday
as
for
occupational
risk
assessments.
Instead,
the
HED
based
calculations
on
what
would
reasonably
be
treated
by
homeowners
such
as
the
size
of
a
lawn,
or
the
size
of
a
garden.
This
information
was
used
by
the
HED
to
define
chemical
use
values
for
handlers
which
in
turn
were
coupled
with
unit
exposure
values
to
calculate
risks.
The
factors
used
for
the
cypermethrin
assessment
were
those
presented
in
the
Health
Effects
Division
Science
Advisory
Committee
Policy
12:
Recommended
Revisions
To
The
Standard
Operating
Procedures
For
Residential
Exposure
Assessment
which
was
completed
on
February
22,
2001.
The
following
daily
volumes
handled
and
area
treated,
excerpted
from
the
policy
and
used
in
each
residential
scenario,
include:
1
sixteen­
ounce
ready­
to­
use
aerosol
can;
2
foggers;
1
one­
gallon
pump
trigger
sprayer
container;
5
gallons
when
mixing/
loading/
applying
liquids
outdoors
with
a
low
pressure
handwand
sprayer;
and
1
animal
when
applying
applications
to
pet
horses.

Residential
Handler
Exposure
Studies:
Risks
were
calculated
using
the
Margin
of
Exposure
(
MOE)
    
38
  
71
approach.
The
unit
exposure
values
that
were
used
in
this
assessment
were
based
on
studies
completed
by
the
Pesticide
Handler
Exposure
Database
(
PHED,
Version
1.1
August
1998).

Much
of
the
process
for
estimating
risks
for
residential
handlers
is
identical
to
that
considered
for
the
occupational
assessment
with
a
few
notable
exceptions
(
e.
g.,
all
are
short­
term
exposures
and
people
wear
shorts
and
short­
sleeved
shirts
with
no
gloves).
The
other
major
difference
with
residential
handler
risk
assessments
is
that
the
uncertainty
factor
which
defines
the
level
of
risk
concern
also
has
any
additional
FQPA
safety
factor
applied.
In
the
case
of
cypermethrin,
the
overall
uncertainty
factor
applied
to
residential
handler
risk
assessments
is
100.
Therefore,
a
MOE
 
100
does
not
exceed
the
HED's
level
of
concern.

Risk
Summary:
The
risk
calculations
for
residential
cypermethrin
handlers
are
included
in
Table
4.4.1
and
summarized
below.

Table
4.4.1:
Cypermethrin
Residential
Handler
Risks
Summary
Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Daily
b
Inhalation
MOEc
Mixer/
Loader/
Applicator
Mixing/
Loading/
Applying
Liquid
concentrates
with
Low
Pressure
Handwand
(
1)
horses
0.017
lbs
ai/
gallon
5
gallons
590,000
Mixing/
Loading/
Applying
Liquid
concentrates
with
Wipes
(
2)
horses
0.017
lbs
ai/
gallon
0.1
gallon
900,000
Applying
Ready
to
Use
Formulations
with
a
Pump
Sprayer
(
PHED
aerosol
can
data)
(
3)
horses
0.017
lbs
ai/
gallon
0.11
gallon
900,000
Applying
Ready
to
Use
Formulations
with
Aerosol
Cans
(
4)
indoor
surfaces,
outdoor
surfaces,
and
animal
premises
0.005
lb
ai/
sixteen
ounce
can
1
can
16,000
Applying
Ready
to
Use
Formulations
with
Fogger
(
5)
indoor
surfaces,
outdoor
surfaces,
and
animal
premises
0.0014
lb
ai/
fogger
2
foggers
28,000
Applying
Ready
to
Use
Formulations
with
Wipes
(
6)
horses
0.00041
lb
ai/
animal
1
animal
6.9E+
09
Footnotes
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
cypermethrin.
b
Amount
handled
per
day
values
are
EPA
estimates
of
amount
treated
based
on
revised
Residential
SOPs
(
2/
01).
c
Baseline
inhalation
MOE
=
NOAEL
(
2.7
mg/
kg/
day)
/
inhalation
daily
dose
(
mg/
kg/
day),
where
inhalation
dose
=
daily
unit
exposure
(
µ
g/
lb
ai)
x
application
rate
x
amount
handled
per
day
x
conversion
factor
(
1mg/
1,000
µ
g
/
body
weight
(
70
kg
adult).

In
residential
settings,
the
Agency
does
not
use
personal
protective
equipment
to
limit
exposures,
because
they
are
viewed
as
impractical
and
not
enforceable.
Risk
estimates
are
based
on
handlers
wearing
short­
sleeve
shirts,
short
pants,
shoes,
and
socks.
For
residential
handlers,
all
risk
estimates
expressed
as
MOEs
are
>
100
and
do
not
exceed
HED's
level
of
concern.

Post­
Application
Exposure
    
39
  
71
Non­
dietary
exposure
for
adults
was
assessed
via
the
inhalation
route
only
(
no
dermal
endpoint),
while
exposure
for
toddlers
was
assessed
via
inhalation
and
oral
routes.
In
general,
postapplication
inhalation
risks
following
outdoor
applications
are
considered
negligible
while
postapplication
inhalation
risks
following
indoor
applications
are
considered
to
potentially
be
of
concern.
For
cypermethrin,
the
indoor
postapplication
inhalation
exposure
risks
were
estimated
from
a
cyfluthrin
room
fogger
study
(
Eberhart,
1987).

A
series
of
assumptions
and
exposure
factors
were
used
as
the
basis
for
completing
the
residential
postapplication
risk
assessments.
Each
assumption
and
factor
is
detailed
below.

­
The
Agency
combines
or
aggregates
risks
resulting
from
exposures
to
individual
chemicals
when
it
is
likely
they
can
occur
simultaneously
based
on
the
use
pattern
and
the
behavior
associated
with
the
exposed
population.
Within
a
residential
assessment,
this
can
take
two
forms.
The
first
is
to
add
together
risks
for
individual
exposure
scenarios
from
all
likely
sources
of
exposure
such
as
after
an
application
to
turf
or
inside
a
home.
For
cypermethrin,
the
Agency
has
added
together
risk
values
(
i.
e.,
MOEs)
for
different
kinds
of
exposures
within
the
turf
(
hand­
to­
mouth,
object­
to­
mouth,
and
soil
ingestion)
and
indoor
scenarios
(
hand­
tomouth
and
inhalation).
These
represent
the
standard
set
of
exposures
that
are
typically
added
together
when
chemicals
are
used
on
turf
or
inside
because
it
is
logical
they
can
co­
occur.
The
second
is
to
add
exposures
from
different
residential
exposure
scenarios
that
can
possibly
cooccur
such
as
when
a
homeowner
makes
an
application
and
then
checks
their
garden
for
insects
a
few
hours
later
on
the
same
day
.

­
Exposures
to
children
playing
on
treated
turf
(
lawncare
and
exercising)
have
been
addressed
using
the
latest
Agency
approaches
for
this
scenario
including:

­
5
percent
of
the
application
rate
has
been
used
to
calculate
the
0­
day
residue
levels
used
for
defining
risks
from
hand­
to­
mouth
behaviors,
measured
TTR
values
 
even
if
available
 
are
not
used
because
of
differences
in
transferability
versus
what
would
be
expected
during
hand­
to­
mouth
behaviors;
­
20
percent
of
the
application
rate
has
been
used
to
calculate
the
0­
day
residue
levels
used
for
defining
risks
from
object­
to­
mouth
behaviors,
measured
TTR
values
 
even
if
available
 
are
not
used
because
of
differences
in
transferability
versus
what
would
be
expected
during
hand­
to­
mouth
behaviors,
a
higher
percent
transfer
has
been
used
for
object­
to­
mouth
behaviors
because
it
involves
a
teething
action
believed
to
be
more
analogous
to
DFR/
leaf
wash
sample
collection
where
20
percent
is
also
used;
­
3
year
old
toddlers
are
expected
to
weigh
15
kg;
­
short­
term
hand­
to­
mouth
exposures
are
based
on
a
frequency
of
20
events/
hour,
and
a
surface
area
per
event
of
20
cm2
representing
the
palmar
surfaces
of
three
fingers
is
used;
­
saliva
extraction
efficiency
is
50
percent
meaning
that
every
time
the
hand
goes
in
the
mouth
approximately
½
of
the
residues
on
the
hand
are
removed;
    
40
  
71
­
object­
to­
mouth
exposures
are
based
on
a
25
cm2
surface
area;
­
exposure
durations
are
expected
to
be
2
hours
based
on
information
in
the
Agency's
Exposure
Factors
Handbook;
­
soil
residues
are
contained
in
the
top
centimeter
and
soil
density
is
0.67
mL/
gram;
and
­
dermal,
hand­
and
object­
to­
mouth,
and
soil
ingestion
are
added
together
to
represent
an
overall
risk
from
exposure
to
turf.

 
Postapplication
residential
risks
are
based
generally
on
maximum
application
rates
or
values
specified
in
the
SOPs
For
Residential
Exposure
Assessment.

The
residential
postapplication
exposure
and
risk
calculations
are
presented
in
this
section.
Risks
were
calculated
using
the
MOE
approach.
The
overall
uncertainty
factor
applied
to
cypermethrin
for
residential
postapplication
risk
assessments
is
100.

Post­
application
short­
term
inhalation
exposures
for
the
indoor
surface
treatment,
were
assessed
using
time­
weighted
averages
(
TWAs)
from
the
cyfluthrin
room
fogger
study
(
Eberhart,
1987).
The
TWAs
cover
the
period
following
2.5
hours
of
ventilation
as
per
label
recommendations.
Post­
application
inhalation
exposure
for
the
use
of
aerosol
spray
treatments
to
carpets
use
air
concentrations
taken
from
the
crack
and
crevice
subset
of
PHED.
A
House
Model
was
then
used
to
estimate
an
emission
rate
based
on
the
dilution
features
of
the
model.
The
study
mentioned
above
will
serve
as
an
appropriate
surrogate
for
cypermethrin
since
synthetic
pyrethroids
have
similar
physical
and
chemical
properties.
Furthermore,
the
vapor
pressure
for
cypermethrin
is
lower
than
most
of
the
other
synthetic
pyrethroids.
Therefore
this
study
should
provide
conservative
estimations
for
indoor
exposures.
The
above
study
was
also
utilized
in
a
recent
risk
assessment
of
zeta­
cypermethrin
(
M.
Collantes,
12/
04/
2001).
Table
4.4.2
summarizes
the
inhalation
exposure
estimates
for
adults,
children
(
1­
6
years
old)
and
infants.
As
the
MOEs
are
all
considerably
greater
than
100,
these
data
show
that
postapplication
inhalation
exposure
to
indoor
surface
treatments
does
not
exceed
HED's
level
of
concern.
The
duration
of
these
inhalation
exposures
may
be
considered
short­
term.

Table
4.4.2.
Residential
Risk
Estimates
for
Postapplication
from
Inhalation
Exposure
to
Cypermethrin
Exposure
Scenario
Route
of
Exposure
Population
Application
Rate
Daily
Dose
(
mg/
kg/
day)
MOEb
Inhalation
Adult
1.25E­
05
216000
Inhalation
Child
(
1­
6)
3.15E­
05
86000
Indoor
surface
Inhalation
Infant
(<
1)
0.000017
lb
ai/
ft2
3.81E­
05
71000
a
Application
rates
represent
maximum
label
rates
from
current
EPA
registered
labels
(
0.000017
lb
ai/
ft2
)
b
Inhalation
MOE
=
Inhalation
NOAEL
(
2.7
mg/
kg/
day
for
short­
term
)/
Daily
Dose
(
mg/
kg/
day).
Target
MOE
is
100.

Table
4.4.3
summarizes
the
residential
risk
estimates
for
postapplication
oral
exposure
to
cypermethrin
residues
for
toddlers.
    
41
  
71
Table
4.4.3.
Residential
Risk
Estimates
for
Postapplication
Oral
Exposure
to
Cypermethrin
Exposure
Scenario
Route
of
Exposure
Population
Application
Ratea
MOEb
Short­
term
Postapplication
Exposures
Outdoors
0.60
lb
ai/
acre,
WP
1100
Hand
to
Mouth
Activity
on
Turfc
Oral
Toddler
0.44
lb
ai/
acre,
Liq.
1,500
0.60
lb
ai/
acre,
WP
4,500
Object
to
Mouth
Activity
on
Turfd
Oral
Toddler
0.44
lb
ai/
acre,
Liq.
6,100
0.60
lb
ai/
acre,
WP
330,000
Incidental
Soil
Ingestione
Oral
Toddler
0.44
lb
ai/
acre,
Liq.
450,000
Indoors
Hand
to
Mouth
Activity
from
Indoor
Surfaces
Following
Crack
&
Crevice
Treatmentf
Oral
Toddler
0.000017
lb
ai/
sq
ft
900
Hand
To
Mouth
Activity
from
Indoor
Surfaces
Following
Broadcast
with
Foggerg
Oral
Toddler
0.00035
lb
ai/
cubic
ft
1400
Footnotes:

a
Application
rates
represent
maximum
label
rates
from
current
EPA
registered
labels
(
Wettable
Powder
rate
is
0.60
lb
ai/
acre,
emulsifiable
concentrate
rate
is
0.44
lb
ai/
acre).
b
MOEs
calculated
using
residues
which
would
be
found
on
day
of
treatment.
Oral
MOE
=
Oral
NOAEL
(
10
mg/
kg/
day
for
short­
term/
Oral
Dose
(
mg/
kg/
day).
Target
MOE
is
100.
c
Hand­
to­
mouth
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
from
potentially
wet
hands
(
5%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
µ
g/
cm2)]
x
median
surface
area
for
1­
3
fingers
(
20
cm
2
/
event)
x
hand­
to­
mouth
rate
(
20
events/
hour)
x
exp.
time
(
2
hr/
day)
x
50%
saliva
extraction
factor
x
0.001
mg/
µ
g]
/
bw
(
15
kg
child).
d
Object
to
Mouth
Activity
on
­
Turf
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
(
5%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
µ
g/
cm2)]
x
median
surface
area
for
1­
3
fingers
(
25
cm
2
/
event)
x
hand­
to­
mouth
rate
(
20
events/
hour)
x
0.001
mg/
µ
g]]
/
bw
(
15
kg
child).
e
Incidental
Soil
ingestion
­
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
(
mg/
kg/
day)
=
[(
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
retained
on
uppermost
1
cm
of
soil
(
100%
or
1.0/
cm)
x
4.54E+
08
µ
g/
lb
conversion
factor
x
2.47E­
08
acre/
cm2
conversion
factor
x
0.67
cm3/
g
soil
conversion
factor)
x
100
mg/
day
ingestion
rate
x
1.0E­
06
g/
µ
g
conversion
factor]
/
bw
(
15
kg).
f
Hand
to
Mouth
Activity
from
Indoor
Surfaces
­
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
sq
ft)
x
fraction
of
residue
dislodgeable
(
5%)
x
4.95E+
5
(
conversion
factor
to
convert
lb
ai/
square
feet
to
µ
g/
cm2)]
x
median
surface
area
for
1­
3
fingers
(
20
cm
2
/
event)
x
hand­
to­
mouth
rate
(
20
events/
hour)
x
exp.
time
(
4
hr/
day)
x
50%
saliva
extraction
factor
x
50%
crack
&
crevice
factor
x
0.001
mg/
µ
g]
/
bw
(
15
kg
child).
g
Hand
to
Mouth
Activity
from
Indoor
Surfaces
(
Fogger)
­
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
fogger
deposition
(
µ
g/
cm2)
x
fraction
of
residue
dislodgeable
(
5%)
x
median
surface
area
for
1­
3
fingers
(
20
cm
2
/
event)
x
hand­
to­
mouth
rate
(
20
events/
hour)
x
exp.
time
(
4
hr/
day)
x
50%
saliva
extraction
factor
x
0.001
mg/
µ
g]
/
bw
(
15
kg
child).
Fogger
deposition
=
lb
ai/
fogger
(
0.0014
lb/
ft3)
x
4.5E+
08
µ
g/
lb
conversion
factor
x
0.001
mg/
µ
g
    
42
  
71
conversion
factor
/
room
area
(
256
ft2).

Table
4.4.4
summarizes
the
residential
risk
estimates
for
postapplication
oral
exposure
to
zetacypermethrin
residues
for
toddlers.

Table
4.4.4:
Residential
Risk
Estimates
for
Postapplication
from
Exposure
to
Zeta­
Cypermethrin
Exposure
Scenario
Route
of
Exposure
Population
Application
Ratea
MOEb
Short­
term
Postapplication
Exposures
Outdoors
Hand
to
Mouth
Activity
on
Turf
Oral
Toddler
0.3
lb
ai/
acre
2,200
Object
to
Mouth
Activity
on
Turf
Oral
Toddler
0.3
lb
ai/
acre
8,900
Incidental
Soil
Ingestion
Oral
Toddler
0.3
lb
ai/
acre
670,000
Indoors
Hand
to
Mouth
Activity
from
Indoor
Surfaces
(
carpet
and
hard
floor)
Oral
Toddler
0.000004
lb
ai/
sq
ft
3,500
Footnotes:
a
Application
rates
represent
maximum
label
rates
from
current
EPA
registered
labels
is
0.30
lb
ai/
acre.
b
MOEs
calculated
using
residues
which
would
be
found
on
day
of
treatment.
Oral
MOE
=
Oral
NOAEL
(
10
mg/
kg/
day
for
shortterm
Oral
Dose
(
mg/
kg/
day).
Target
MOE
is
100.
c
Hand­
to­
mouth
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
from
potentially
wet
hands
(
5%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
µ
g/
cm2)]
x
median
surface
area
for
1­
3
fingers
(
20
cm
2
/
event)
x
hand­
to­
mouth
rate
(
20
events/
hour)
x
exp.
time
(
2
hr/
day)
x
50%
saliva
extraction
factor
x
0.001
mg/
µ
g]
/
bw
(
15
kg
child).
d
Object
to
Mouth
Activity
on
­
Turf
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
(
5%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
µ
g/
cm2)]
x
median
surface
area
for
1­
3
fingers
(
25
cm
2
/
event)
x
hand­
to­
mouth
rate
(
20
events/
hour)
x
0.001
mg/
µ
g]]
/
bw
(
15
kg
child).
e
Incidental
Soil
ingestion
­
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
(
mg/
kg/
day)
=
[(
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
retained
on
uppermost
1
cm
of
soil
(
100%
or
1.0/
cm)
x
4.54E+
08
µ
g/
lb
conversion
factor
x
2.47E­
08
acre/
cm2
conversion
factor
x
0.67
cm3/
g
soil
conversion
factor)
x
100
mg/
day
ingestion
rate
x
1.0E­
06
g/
µ
g
conversion
factor]
/
bw
(
15
kg).
f
Hand
to
Mouth
Activity
from
Indoor
Surfaces
­
Dose
Calculation:
oral
dose
to
child
(
1­
6
year
old)
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
sq
ft)
x
fraction
of
residue
dislodgeable
(
5%)
x
4.95E+
5
(
conversion
factor
to
convert
lb
ai/
square
feet
to
µ
g/
cm2)]
x
median
surface
area
for
1­
3
fingers
(
20
cm
2
/
event)
x
hand­
to­
mouth
rate
(
20
events/
hour)
x
exp.
time
(
4
hr/
day)
x
50%
saliva
extraction
factor
x
0.001
mg/
µ
g]
/
bw
(
15
kg
child).

Note:
Assumptions
used
in
dose
calculations
(
e.
g.,
transfer
coefficients)
are
from
Residential
SOPs
(
revised
2/
01).

Short­
term
risks
were
estimated
for
toddlers
based
on
incidental
oral
exposures
outdoors
on
turf
and
indoors
on
treated
surfaces.
Risk
estimates
for
short­
term
dermal
exposure
for
adults
or
children
were
not
calculated
because
no
short­
term
dermal
endpoint
was
identified
in
the
toxicity
database.
Risk
estimates
on
the
day
of
application
are
the
key
concern
and
the
risk
estimates
are
based
on
persons
wearing
short­
sleeve
shirts,
short
pants,
shoes,
and
socks.

For
residential
postapplication
risks,
MOEs
are
of
concern
if
they
are
less
than
100
and
exceed
the
Agency's
level
of
concern
for
risk
assessments
in
nonoccupational
settings.
    
43
  
71
The
residential
postapplication
scenarios
where
risks
are
not
of
concern
(
i.
e.,
MOE
 
100)
include
all
scenarios
considered.

Aggregate
Risk
Estimates
for
Residential
Scenarios
The
Agency
aggregates
risk
values
resulting
from
separate
exposure
scenarios
when
it
is
likely
they
can
occur
simultaneously
based
on
the
use­
pattern
and
the
behavior
associated
with
the
exposed
population.
For
cypermethrin,
the
Agency
aggregated
risk
values
(
i.
e.,
MOEs)
for
postapplication
exposures
to
toddlers
associated
with
turf
applications
by
comparing
risks
from
all
oral
exposures.
Because
conservative
assumptions
were
made
in
the
calculation
of
the
daily
doses
for
all
oral
exposures,
it
was
considered
unrealistic
to
sum
the
individual
daily
doses
to
arrive
at
an
aggregate
risk
estimate.
Rather,
the
maximum
single
exposure
was
considered
protective
for
the
aggregate
risk
estimate.
For
cypermethrin,
the
oral
hand
to
mouth
exposure
was
calculated
to
result
in
the
highest
daily
dose
for
toddlers.
Based
on
this
analysis,
the
residential
turf
uses
of
cypermethrin
and
zetacypermethrin
do
not
exceed
HED's
level
of
concern
as
the
MOEs
are
all
greater
than
100.

Table
4.4.5:
Combined
Short­
Term
Cypermethrin
Residential
Scenarios
for
Postapplication
Risk
Estimates
Margins
of
Exposure
(
MOEs)
(
UF=
100)

Exposure
Scenario
Dermal
Oral
(
Non­
Dietary)
Total
Non­
Dietary
Risk
a
Short­
term
Exposures
Hand
to
Mouth
N/
A
1,100
Object
to
Mouth
N/
A
4,500
Toddler
Turf:
wettable
powder
formulation
(
0.60
lb
ai/
acre)
on
turf
Postapp
Incidental
Soil
Ingestion
N/
A
330,000
1100
Hand
to
Mouth
N/
A
1,500
Object
to
Mouth
N/
A
6,100
Toddler
Turf:
liquid
formulation
(
0.44
lb
ai/
acre)
on
turf
Postapp
Incidental
Soil
Ingestion
N/
A
450,000
1500
a
Based
on
the
hand
to
mouth
exposure
scenario
as
this
route
of
exposure
was
determined
to
lead
to
the
highest
level
of
risk.
Due
to
the
conservative
assumptions
built
into
the
determination
of
each
daily
dose
(
and
resulting
MOE),
it
was
considered
unrealistic
to
sum
the
daily
doses
from
each
possible
exposure
(
ie,
hand
to
mouth
exposure
+
object
to
mouth
exposure
+
incidental
soil
ingestion).
    
44
  
71
Table
4.4.6:
Combined
Short­
Term
Zeta­
Cypermethrin
Residential
Scenarios
for
Postapplication
Risk
Estimates
Margins
of
Exposure
(
MOEs)
(
UF=
100)

Exposure
Scenario
Dermal
Oral
(
Non­
Dietary)
Total
Non­
Dietary
Riska
Hand
to
Mouth
N/
A
2,200
Object
to
Mouth
N/
A
8,900
Toddler
Turf
(
0.3
lb
ai/
acre)
Postapp
Incidental
Soil
Ingestion
N/
A
670,000
2200
a
Based
on
the
hand
to
mouth
exposure
scenario
as
this
route
of
exposure
was
determined
to
lead
to
the
highest
level
of
risk.
Due
to
the
conservative
assumptions
built
into
the
determination
of
each
daily
dose
(
and
resulting
MOE),
it
was
considered
unrealistic
to
sum
the
daily
doses
from
each
possible
exposure
(
ie,
hand
to
mouth
exposure
+
object
to
mouth
exposure
+
incidental
soil
ingestion).

4.5
Spray
Drift
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
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices
and
State
Lead
Agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
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
air­
blast
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
and
risks
associated
with
aerial
as
well
as
other
application
types
where
appropriate.

5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
Aggregate
risk
assessments
for
cypermethrin
were
conducted
as
follows:
acute
and
chronic
aggregate
assessments
were
conducted
based
on
food
and
water
exposures,
and
short­
term
aggregate
assessments
were
conducted
based
on
food,
water,
and
residential
exposures.
No
intermediate­
or
long­
term
aggregate
risk
assessments
were
conducted
because
no
intermediate­
or
long­
term
exposure
scenarios
are
expected
from
residential
uses
of
cypermethrin.

Under
OPP's
aggregate
risk
assessments
for
cypermethrin,
HED
has
compared
estimates
of
    
45
  
71
concentrations
of
cypermethrin
in
drinking
water
to
Drinking
Water
Levels
of
Comparison
(
DWLOCs).
A
DWLOC
is
the
portion
of
the
acute
PAD
or
chronic
PAD
remaining
after
estimated
dietary
(
food
only)
exposures
have
been
subtracted
and
the
remaining
exposure
has
been
converted
to
a
concentration
(
ppb).
This
concentration
value
(
DWLOC)
represents
the
available
or
allowable
exposure
through
drinking
water
for
cypermethrin.
Under
the
acute
risk
assessment,
the
remaining
portion
of
the
acute
PAD
is
based
on
dietary
exposures
at
the
99.9th
percentile
of
exposure
for
each
relevant
population
subgroup
considered.
Under
the
chronic
risk
assessment,
the
remaining
portion
of
the
chronic
PAD
is
based
on
average
dietary
exposures
for
each
relevant
population
subgroup
considered.
Maximum
EECs
of
cypermethrin
in
ground
and
surface
water
that
are
less
than
the
acute
DWLOCs,
and
average
concentrations
of
cypermethrin
that
are
less
than
chronic
DWLOCs,
do
not
exceed
HED s
level
of
concern.
DWLOC
values
vary
for
population
subgroups
depending
on
dietary
exposure
through
foods
for
each
subgroup,
and
the
assumptions
made
about
drinking
water
consumption,
and
body
weights
for
each
subgroup.

5.1
Acute
Aggregate
Risk
Table
5.1.1
summarizes
the
acute
DWLOCs
calculated
for
the
various
population
subgroups
indicated.
Comparison
of
the
acute
DWLOCs
to
maximum
EECs
for
surface
and
ground
water
show
that
acute
DWLOCs
are
greater
than
the
EECs
for
acute
exposure
for
all
population
subgroups.
Therefore,
HED
is
reasonably
certain
that
acute
aggregate
exposures
to
cypermethrin
result
in
risk
estimates
below
HED s
level
of
concern.

Table
5.1.1
Acute
DWLOC
Calculations.

Population
Subgroup
aPAD
mg/
kg/
day
Food
Exp
mg/
kg/
day
Max
Water
Exp
mg/
kg/
daya
Ground
Water
EEC
(
µ
g/
L)
Surface
Water
EEC
(
µ
g/
L)
DWLOC
(
µ
g/
L)
b
General
U.
S.
Population
0.002600
0.097400
3400
All
Infants
(<
1
year
old)
0.005644
0.094356
940
Children
1­
2
years
old
0.006084
0.093916
940
Children
3­
5
years
old
0.003687
0.096313
960
Children
6­
12
years
old
0.002293
0.097707
980
Youth
13­
19
years
old
0.001675
0.098325
2900
Adults
20­
49
years
old
0.001383
0.098617
3500
Females
13­
49
years
old
0.001415
0.098585
3000
Adults
50+
years
old
0.1
0.001397
0.098603
0.0036
1.04
3500
a
Maximum
water
exposure
(
mg/
kg/
day)
=
[(
acute
PAD
(
mg/
kg/
day)
­
food
exposure
(
mg/
kg/
day)]
    
46
  
71
b
DWLOC(
µ
g/
L)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)]
÷
[
water
consumption
(
L)
x
10­
3
mg/
µ
g].
Consumption
=
1
L/
day
for
populations
<
13
years
old
and
2
L/
day
for
populations
 
13
years
old.
Default
body
weights
=
70
kg
for
adults
>
20
years
old
and
general
U.
S.
population,
60
kg
for
females
 
13
years
old
and
youth
13­
19
years
old,
and
10
kg
for
all
others.
Values
are
rounded
to
2
significant
figures.
    
47
  
71
5.2
Short­
Term
Aggregate
Risk
Assessment
(
Average
food
+
drinking
water
+
residential
exposure)

Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
average
exposure
levels
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Cypermethrin
registered
residential
uses
constitute
short­
term
exposure
scenarios;
endpoints
have
been
selected
for
short­
term
incidental
oral
and
inhalation
exposures,
and
the
acceptable
MOEs
for
short­
term
exposures
are
100.
Since
the
toxicological
effects
through
the
inhalation
exposure
route
are
similar
to
those
toxicological
effects
through
the
oral
routes,
short­
term
aggregate
risk
assessment
was
conducted
adding
inhalation,
oral
non­
dietary
exposure,
and
average
food
and
water
exposure.

Since
all
the
acceptable
MOEs
are
at
the
same
level,
the
aggregate
risks
for
population
subgroups
can
be
estimated
by
calculating
aggregate
Margin
of
Exposure
values
(
MOEaggregate).

MOEaggregate
=
1
1
+
1
+
1
+
1
+
1
MOEI
MOED
MOEO
MOEFOOD
MOEWATER
where
I
=
inhalation,
D
=
dermal
(
no
dermal
endpoint
was
selected
for
cypermethrin),
O
=
non­
dietary
oral,
MOEFOOD
=
average
food
from
the
chronic
DEEM
run.

For
the
short­
term
aggregate
risk
assessments,
DWLOCs
were
calculated
for
comparison
with
EECs.
Table
5.2.1
below
shows
the
short­
term
DWLOC
calculations
and
values.

For
all
the
population
subgroups
shown
in
Table
5.2.1,
the
computed
ground
and
surface
water
EEC
values
do
not
exceed
the
DWLOC
values.
Thus,
short­
term
aggregate
risk
does
not
exceed
HED's
level
of
concern
for
any
of
the
residential
exposure
scenarios
examined.
The
lowest
DWLOC
value
of
890
ppb
was
calculated
for
children
1­
2
years
old
and
this
level
is
higher
than
the
surface
and
ground
water
EECs
of
0.013
and
0.0036
ppb,
respectively.
The
incidental
oral
residential
exposure
value
selected
for
the
aggregate
analysis
was
based
on
hand
to
mouth
activity
from
indoor
surfaces
following
crack
and
crevice
treatment,
as
this
scenario
resulted
in
the
highest
calculated
exposure
level,
and
is
therefore
considered
protective
for
all
other
exposure
scenarios.
    
48
  
71
Table
5.2.1.
Short­
Term
Aggregate
Risk
and
DWLOC
Calculations
(
1/
MOE
Approach
­
All
Target
MOEs
Identical)
Short
­
Term
Scenario
Population
Target
Aggregate
MOE1
MOE
food2
MOE
oral3
MOE
dermal4
MOE
inhalation5
Aggregate
MOE
(
food
and
residential)
6
MOE
water7
Allowable
water
exposure8
(
mg/
kg/
day)
Ground
Water
EEC9
(
µ
g/
L)
Surface
Water
EEC9
(
µ
g/
L)
DWLOC10
(
µ
g/
L)

US
Population
100
20000
0
N/
A
N/
A
15000
14000
101
0.099329
0.0036
0.013
3500
Females
13­

49
years
old
100
24000
0
N/
A
N/
A
15000
14000
101
0.099287
0.0036
0.013
3000
Children
1­
2
years
old
100
10500
0
900
N/
A
86000
883
113
0.088678
0.0036
0.013
890
All
infants
<
1
year
old
100
20000
0
N/
A
N/
A
71000
52000
100
0.099809
0.0036
0.013
1000
1
Target
MOE
based
on
10x
for
interspecies
variation
and
10x
for
intraspecies
variation.

2
MOE
food
=
[(
short­
term
oral
NOAEL)/(
chronic
dietary
exposure)]
exposure
from
Table
4.2.3.1,
and
NOAEL
=
10.

3
MOE
oral
=
[(
short­
term
oral
NOAEL)/(
total
incidental
oral
residential
exposure)]
exposure
from
Table
4.4.3,
and
NOAEL
=
10.
The
total
incidental
oral
residential
exposure
value
selected
was
for
hand
to
mouth
activity
from
indoor
surfaces
following
crack
and
crevice
treatment
as
this
scenario
resulted
in
the
highest
calculated
exposure
level,
and,
therefore,
is
protective
for
all
other
scenarios.

4
MOE
dermal
=
No
dermal
endpoints
were
selected.

5
MOE
inhalation
=
[(
inhalation
NOAEL)/(
inhalation
handler
exposure
+
postapplication
inhalation
exposure)]
exposure
from
Tables
4.4.1
and
4.4.2,
and
NOAEL
=
2.7.

The
inhalation
handler
exposure
MOE
selected
was
based
on
the
scenario
for
handler
exposure
to
RTU
formulations
with
aerosol
cans,
and
this
exposure
was
combined
with
residential
indoor
surface
postapplication
inhalation
exposure
listed
in
Table
4.4.2.

6
Aggregate
MOE
(
food
and
residential)
=
1
÷
[
[(
1
÷
MOE
food)
+
(
1
÷
MOE
oral)
+
(
1
÷
MOE
dermal)
+
(
1
÷
MOE
inhalation)]]

7
Water
MOE
=
1
÷
[[(
1
÷
Target
Aggregate
MOE)
­
(
1
÷
Aggregate
MOE
(
food
and
residential)]]

8
Allowable
water
exposure
=
Short­
Term
Oral
NOAEL
÷
MOE
water
9
The
crop
producing
the
highest
level
was
used.

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

[
water
consumption
(
L)
x
10­
3
mg/
µ
g]

body
weights
for
male,
female,
and
children
are
70,
60,
and
10
kg.
Water
consumption
for
male,
female,
and
children
are
2,
2,
and
1
liter/
day
    
49
  
71
5.3
Chronic
Aggregate
Risk
Estimates
of
chronic
(
average)
exposure
from
food
were
taken
from
the
dietary
exposure
model
results
described
above
(
Section
4.2.3).
These
exposure
estimates
are
based
on
USDA
PDP
monitoring
data,
crop
field
trial
data,
estimated
percent
crop
treated
information,
and
processing
factors
and
may
be
considered
refined.

For
considering
exposure
to
residues
of
cypermethrin
in
drinking
water,
HED
has
calculated
chronic
DWLOCs.
These
values
are
the
maximum
concentration
of
a
chemical
that
can
occur
in
drinking
water
after
taking
into
account
chronic
exposures
to
residues
of
cypermethrin
from
other
pathways
and
sources.
Long
term
exposures
from
residential
uses
are
not
expected
for
cypermethrin.
Therefore,
the
chronic
aggregate
risk
calculations
include
contributions
only
from
food
and
water
sources.
The
chronic
DWLOCs
are
compared
against
the
modeled
EECs
for
chronic
exposure
provided
by
EFED
(
see
Section
4.3).
DWLOC
values
that
are
greater
than
the
EECs
indicate
that
aggregate
exposures
are
unlikely
to
exceed
HED s
level
of
concern.

As
shown
in
Table
5.3.1,
the
chronic
DWLOCs
for
the
general
U.
S.
population
and
all
of
the
representative
population
subgroups
modeled
by
DEEM­
FCID
are
greater
than
both
the
surface
water
and
ground
water
EECs.
Chronic
aggregate
risk
estimates
associated
with
exposure
to
cypermethrin
residues
in
food
and
water
do
not
exceed
HED s
level
of
concern.

Table
5.3.1
Chronic
DWLOC
Calculations.

Population
Subgroup
cPAD
mg/
kg/
day
Food
Exp
mg/
kg/
day
Max
Water
Exp
mg/
kg/
daya
Ground
Water
EEC
(
µ
g/
L)
Surface
Water
EEC
(
µ
g/
L)
DWLOC
(
µ
g/
L)
b
General
U.
S.
Population
0.000043
0.059957
2100
All
Infants
(<
1
year
old)
0.000049
0.059951
600
Children
1­
2
years
old
0.000095
0.059905
600
Children
3­
5
years
old
0.000083
0.059917
600
Children
6­
12
years
old
0.000057
0.059943
600
Youth
13­
19
years
old
0.000038
0.059962
1800
Adults
20­
49
years
old
0.000037
0.059963
2100
Females
13­
49
years
old
0.000035
0.059965
1800
Adults
50+
years
old
0.06
0.000034
0.059966
0.0036
0.013
2100
a
Maximum
water
exposure
(
mg/
kg/
day)
=
[(
chronic
PAD
(
mg/
kg/
day)
­
food
exposure
(
mg/
kg/
day)]

b
DWLOC(
µ
g/
L)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)]
÷
[
water
consumption
(
L)
x
10­
3
    
50
  
71
mg/
µ
g].
Consumption
=
1
L/
day
for
populations
<
13
years
old
and
2
L/
day
for
populations
 
13
years
old.

Default
body
weights
=
70
kg
for
males
>
20
years
old
and
general
U.
S.
population,
60
kg
for
females
 
13
years
old
and
youths
13­
19
years
old,
and
10
kg
for
all
others.
Values
are
rounded
to
2
significant
figures.

5.4
Cancer
Aggregate
Risk
Cypermethrin
has
been
classified
as
a
Category
C,
possible
human
carcinogen,
based
on
an
increased
incidence
of
lung
adenomas
and
adenomas
plus
carcinomas
combined
in
female
mice
(
Cancer
Peer
Review
Committee,
1988).
The
evidence
was
not
considered
strong
enough
to
warrant
a
quantitative
estimation
of
human
risk.
The
endpoint
selected
for
the
chronic
population
adjusted
dose
(
cPAD)
will
be
protective
of
the
possible
carcinogenic
activity
of
this
chemical.
Structure­
activity
comparisons
with
the
pyrethroid
class
of
insecticides
indicate
that
lung
tumors
in
mice
were
induced
with
3
other
pyrethroids.

6.0
CUMULATIVE
RISK
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information 
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity. 

Cypermethrin
is
a
member
of
the
pyrethroid
class
of
pesticides.
Although
all
pyrethroids
alter
nerve
function
by
modifying
the
normal
biochemistry
and
physiology
of
nerve
membrane
sodium
channels,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids.
Although
all
pyrethroids
interact
with
sodium
channels,
there
are
multiple
types
of
sodium
channels
and
it
is
currently
unknown
whether
the
pyrethroids
have
similar
effects
on
all
channels.
Nor
do
we
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function
e.
g.,
nerve
excitability,
nor
do
we
understand
how
these
key
events
interact
to
produce
their
compound
specific
patterns
of
neurotoxicity.
There
is
ongoing
research
by
the
EPA s
Office
of
Research
and
Development
and
pyrethroid
registrants
to
evaluate
the
differential
biochemical
and
physiological
actions
of
pyrethroids
in
mammals.
This
research
is
expected
to
be
completed
by
2007.
When
available,
the
Agency
will
consider
this
research
and
make
a
determination
of
common
mechanism
as
a
basis
for
assessing
cumulative
risk.
For
information
regarding
EPA s
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
AND
RISK
7.1
Occupational
Handler
    
51
  
71
For
the
agricultural
crop
scenarios
using
PHED
data,
the
inhalation
risks
are
not
a
concern
at
baseline
attire
for
applying
sprays
with
groundboom
and
airblast
equipment
and
for
flagging
to
support
aerial
applications.
The
risks
to
handlers
mixing
and
loading
to
support
applications
to
agricultural
crops
(
including
chemigation
applications)
are
not
a
concern
at
baseline
attire
with
one
exception,
handlers
mixing
and
loading
to
support
aerial
applications
to
cotton
(
a
high
acreage
crop)
required
the
addition
of
a
dust­
mist
respirator.
EPA
has
insufficient
data
to
assess
exposures
to
pilots
in
open
cockpits.
Risks
to
pilots
in
enclosed
cockpits
(
engineering
control
scenario)
were
not
a
concern
for
all
agricultural
crop
scenarios.
Short­
and
intermediate­
term
dermal
exposures
and
risks
were
not
assessed
for
cypermethrin,
since
no
short­
or
intermediate­
term
dermal
endpoint
was
identified.

Chronic
exposures
were
only
expected
for
turf
(
LCOs)
and
termiticides
(
PCOs)
applications
in
industrial,
commercial,
and
residential
settings.
The
risks
are
not
a
concern
at
baseline
attire
for
mixing/
loading/
applying
liquids
and
water
soluble
bags
to
turfgrass
using
handgun
equipment
(
ORETF
data).
Using
PHED
data,
risks
are
not
a
concern
at
baseline
attire
for
mixing/
loading/
applying
liquids
to
turfgrass
using
a
low
pressure
handwand,
mixing/
loading/
applying
wettable
powders
to
standing
wood
(
termites)
using
a
paint
brush,
and
mixing/
loading/
applying
wettable
powders
to
wood
using
a
termiticides
injector.
The
risks
are
not
a
concern
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire
for
mixing/
loading/
applying
wettable
powders
to
turfgrass
using
handgun
equipment
(
ORETF
data).
Using
PHED
data,
risks
are
not
of
concern
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire
for
mixing/
loading/
applying
with
low­
pressure
handwand
sprayers
(
termiticide
applications),
backpack
sprayers,
and
paintbrushes
(
all
other
termite
applications).

For
the
applications
in
industrial,
commercial,
and
residential
settings,
the
inhalation
risks
are
not
a
concern
at
baseline
attire
for
all
mixing/
loading/
applying
scenarios.
Note
that
there
is
no
inhalation
risk
data
for
applying
ready­
to­
use
ear
tags
to
horses,
however
the
inhalation
risk
from
this
exposure
pattern
is
not
expected
to
be
a
concern
because
of
the
low
volatility
of
cypermethrin,
the
dissipating
effects
of
wind
likely
in
outdoor
conditions,
and
the
relatively
low
amounts
of
cypermethrin
in
ear
tags.

7.2
Occupational
Postapplication
Worker
EPA
did
not
assess
occupational
postapplication
risks
to
agricultural
workers
following
treatments
to
agricultural
crops,
since
no
short­
or
intermediate­
term
dermal
endpoint
of
concern
was
identified
and
long­
term
dermal
exposures
are
not
expected
for
tasks
involving
any
of
the
registered
crop
use
patterns.
In
lieu
of
a
postapplication
risk
assessment,
a
restricted­
entry
interval
of
12
hours
is
assumed,
unless
the
active
ingredient
and
formulation
meet
all
of
the
criteria
listed
in
PR
Notice
95­
3
for
low
risk
pesticides.
    
52
  
71
Table
7.2.1.
Cypermethrin
Occupational
Handler
Summary
Risks
(
Short­
and
Intermediate­
Term
Risks)

Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
Mixer/
Loader
agricultural
uncultivated
areas;
fencerows,
hedgerows
3.4
lb
ai/
acre
350
acres
130
660
1,900
cotton
0.1
lb
ai/
acre
1200
acres
1,300
6,600
19,000
Mixing/
Loading
Liquid
Concentrates
for
Aerial
Application
(
1a)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,
pecans,

rape
greens
0.1
lb
ai/
acre
350
acres
4,500
23,000
65,000
Mixing/
Loading
Liquid
Concentrates
for
Chemigation
Application
(
1b)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
cotton,

head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,

pecans,
rape
greens
0.1
lb
ai/
acre
350
acres
4,500
23,000
65,000
agricultural
uncultivated
areas;
fencerows,
hedgerows
3.4
lb
ai/
acre
80
acres
580
2,900
8,400
ornamental
plants
3.4
lb
ai/
acre
40
acres
1,200
5,800
17,000
cotton
0.1
lb
ai/
acre
200
acres
7,900
39,000
110,000
Mixing/
Loading
Liquid
Concentrates
for
Groundboom
Application
(
1c)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,
pecans,

rape
greens
0.1
lb
ai/
acre
80
acres
20,000
98,000
280,000
pecans
0.1
lb
ai/
acre
40
acres
39,000
200,000
570,000
Mixing/
Loading
Liquid
Concentrates
for
Airblast
Application
(
1d)
ornamental
plants
3.4
lb
ai/
acre
20
acres
2,300
12,000
33,000
agricultural
uncultivated
areas;
fencerows,
hedgerows
3.4
lb
ai/
acre
350
acres
4
18
660
sodfarms
0.74
lb
ai/
acre
350
acres
17
85
3,000
Mixing/
Loading
Wettable
Powders
for
Aerial
Application
(
2a)
cotton
0.1
lb
ai/
acre
1200
acres
37
180
6,600
    
53
  
71
Table
7.2.1.
Cypermethrin
Occupational
Handler
Summary
Risks
(
Short­
and
Intermediate­
Term
Risks)

Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
Mixing/
Loading
Wettable
Powders
for
Aerial
Application
(
2a)
(
cont.)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,
pecans,

rape
greens,
0.1
lb
ai/
acre
350
acres
130
630
23,000
Mixing/
Loading
Wettable
Powders
for
Chemigation
Application
(
2b)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
cotton,

head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,

pecans,
rape
greens,
0.1
lb
ai/
acre
350
acres
130
630
23,000
agricultural
uncultivated
areas;
fencerows,
hedgerows
3.4
lb
ai/
acre
80
acres
16
81
2,900
ornamental
plants
3.4
lb
ai/
acre
40
acres
32
160
5,800
sodfarms
0.74
lb
ai/
acre
80
acres
74
370
13,000
cotton
0.1
lb
ai/
acre
200
acres
220
1,100
39,000
Mixing/
Loading
Wettable
Powders
for
Groundboom
Application
(
2c)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,
rape
greens
0.1
lb
ai/
acre
80
acres
550
2,700
98,000
ornamental
plants
3.4
lb
ai/
acre
20
acres
65
320
12,000
Mixing/
Loading
Wettable
Powders
for
Airblast
Application
(
2d)
pecans
0.1
lb
ai/
acre
40
acres
1,100
5,500
200,000
Applicator
agricultural
uncultivated
areas;
fencerows,
hedgerows
3.4
lb
ai/
acre
350
acres
see
Eng.
Controls
see
Eng.
Controls
2,300
sodfarms
0.74
lb
ai/
acre
350
acres
see
Eng.
Controls
see
Eng.
Controls
11,000
Applying
Sprays
with
an
Airplane
(
3)
cotton
0.1
lb
ai/
acre
1200
acres
see
Eng.
Controls
see
Eng.
Controls
23,000
Applying
Sprays
with
an
Airplane
(
3)
(
cont.)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,
pecans,

rape
greens
0.1
lb
ai/
acre
350
acres
see
Eng.
Controls
see
Eng.
Controls
79,000
    
54
  
71
Table
7.2.1.
Cypermethrin
Occupational
Handler
Summary
Risks
(
Short­
and
Intermediate­
Term
Risks)

Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
agricultural
uncultivated
areas;
fencerows,
hedgerows
3.4
lb
ai/
acre
80
acres
940
4,600
16,000
ornamental
plants
3.4
lb
ai/
acre
40
acres
1,900
9,300
32,000
sodfarms
0.74
lb
ai/
acre
80
acres
4,300
21,000
74,000
cotton
0.1
lb
ai/
acre
200
acres
13,000
63,000
220,000
Applying
Sprays
with
Groundboom
Application
(
4)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,
rape
greens
0.1
lb
ai/
acre
80
acres
32,000
160,000
550,000
ornamental
plants
3.4
lb
ai/
acre
20
acres
620
3,100
6,200
Applying
Sprays
with
an
Airblast
(
5)
pecans
0.1
lb
ai/
acre
40
acres
11,000
53,000
110,000
Flagger
agricultural
uncultivated
areas;
fencerows,
hedgerows
3.4
lb
ai/
acre
350
acres
450
2,300
23,000
sodfarms
0.74
lb
ai/
acre
350
acres
2,100
10,000
100,000
Flagging
for
Aerial
Sprays
(
6)
broccoli,
broccoli
raab,
brussel
sprouts,
bok
choy,
cabbage,
cauliflower,

cavalo
broccolo,
Chinese
broccoli,
Chinese
cabbage,
collards,
cotton,

head
lettuce,
kale,
kohlrabi
mizuna,
mustard
greens,
mustard
spinach,

pecans,
rape
greens
0.1
lb
ai/
acre
350
acres
15,000
77,000
770,000
Mixer/
Loader/
Applicator
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Low
Pressure
Handwand
(
7)
residential,
commercial
and
industrial
lawns
0.44
lb
ai/
acre
5
acres
2,900
14,000
Not
Feasible
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,

building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
40
gallons
3,200
16,000
Not
Feasible
Termites
applications
to
preconstruction
lumber
and
logs,
and
to
soil
under
firewood
0.041
lb
ai/
gallon
40
gallons
3,800
19,000
Not
Feasible
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Low
Pressure
Handwand
(
7)
(
cont.)
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,

commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
0.017
lb
ai/
gallon
40
gallons
9,300
46,000
Not
Feasible
    
55
  
71
Table
7.2.1.
Cypermethrin
Occupational
Handler
Summary
Risks
(
Short­
and
Intermediate­
Term
Risks)

Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
applications
to
horses
ornamental
plants;
termite
applications
to
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.008
lb
ai/
gallon
40
gallons
20,000
98,000
Not
Feasible
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,

building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
5
gallons
2,700
14,000
Not
Feasible
Termites
applications
to
preconstruction
lumber
and
logs,
and
to
soil
under
firewood
0.041
lb
ai/
gallon
5
gallons
3,300
16,000
Not
Feasible
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Paintbrush
(
8)
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,

commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
0.017
lb
ai/
gallon
5
gallons
7,900
40,000
Not
Feasible
agricultural
uncultivated
areas;
fencerows,
hedgerows;
ornamental
plants;
potting
soil,
topsoil
3.4
lb
ai/
acre
5
acres
6,200
31,000
Not
Feasible
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Handheld
Handgun
(
ORETF)
(
9)
residential,
commercial
and
industrial
lawns
0.44
lb
ai/
acre
5
acres
48,000
240,000
Not
Feasible
Mixing/
Loading/
Applying
Liquid
Concentrates
with
an
Termiticide
Injector
(
10)
Termites:
trees,
utility
poles,
fenceposts,
building
voids
0.05
lb
ai/
gallon
500
gallons
3,400
17,000
Not
Feasible
residential,
commercial
and
industrial
lawns
0.6
lb
ai/
acre
5
acres
57
290
Not
Feasible
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,

building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
40
gallons
86
430
Not
Feasible
Mixing/
Loading/
Applying
Wettable
Powders
with
a
Low
Pressure
Handwand
(
11)
fire
ant
mounds
0.033
lb
ai/
gallon
40
gallons
130
650
Not
Feasible
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,

commercial
and
industrial
sites,
animal
premises,
and
greenhouses;

applications
to
horses
0.017
lb
ai/
gallon
40
gallons
250
1,300
Not
Feasible
Mixing/
Loading/
Applying
Wettable
Powders
with
a
Low
Pressure
Handwand
(
11)
(
cont.)
ornamental
plants;
termite
applications
to
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.008
lb
ai/
gallon
40
gallons
540
2,700
Not
Feasible
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,

building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
5
gallons
2,700
14,000
Not
Feasible
Mixing/
Loading/
Applying
Wettable
Powders
with
a
Paintbrush
(
using
PHED
liquid
paintbrush)
(
12)
    
56
  
71
Table
7.2.1.
Cypermethrin
Occupational
Handler
Summary
Risks
(
Short­
and
Intermediate­
Term
Risks)

Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
Termites
applications
to
preconstruction
lumber
and
logs,
and
to
soil
under
firewood
0.041
lb
ai/
gallon
5
gallons
3,300
16,000
Not
Feasible
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,

commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
0.017
lb
ai/
gallon
5
gallons
7,900
40,000
Not
Feasible
agricultural
uncultivated
areas;
fencerows,
hedgerows;
ornamental
plants;
potting
soil,
topsoil
3.4
lb
ai/
acre
5
acres
170
870
Not
Feasible
Mixing/
Loading/
Applying
Wettable
Powders
Formulations
with
a
Handheld
Handgun
(
ORETF)
(
13)
residential,
commercial
and
industrial
lawns
0.6
lb
ai/
acre
5
acres
980
4,900
Not
Feasible
agricultural
uncultivated
areas;
fencerows,
hedgerows;
ornamental
plants;
potting
soil,
topsoil
3.4
lb
ai/
acre
5
acres
1,500
7,700
Not
Feasible
Mixing/
Loading/
Applying
Wettable
Powders
in
Water
Soluble
Packaging
with
a
Handheld
Handgun
(
ORETF)
(
14)
residential,
commercial
and
industrial
lawns
0.6
lb
ai/
acre
5
acres
8,800
44,000
Not
Feasible
Applying
Ready
to
Use
Formulations
via
RTU
Tag
(
15)
cattle
0.003
lb
ai/
2
ear
tags
100
and
1000
cattle
No
Data
No
Data
Not
Feasible
Applying
Ready
to
Use
Formulations
with
Pump
Trigger
Sprayers
(
16)
horses
0.017
lb
ai/
gallon
1
gallon
90,000
450,000
Not
Feasible
500
horses
14,000,000
69,000,000
Not
Feasible
Applying
Ready
to
Use
Formulations
with
Wipes
(
17)
horses
0.00041
lb
ai/
wipe
50
horses
140,000,00
0
690,000,000
Not
Feasible
Applying
Ready
to
Use
Formulations
with
Aerosol
Cans
(
18)
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,

commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
0.005
lb
ai/
16
oz
can
2
cans
15,000
73,000
Not
Feasible
Applying
Ready
to
Use
Formulations
with
Fogger
(
19)
Non­
termite
applications
to
indoor
spaces
at
residential,
commercial
and
industrial
sites,
animal
premises,
and
greenhouses
0.0014
lb
ai/
fogger
4
foggers
26,000
130,000
Not
Feasible
Footnotes
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
cypermethrin.

b
Amount
handled
per
day
values
are
EPA
estimates
of
acreage
treated
or
gallons
applied
based
on
Exposure
SAC
Policy
#
9
"
Standard
Values
for
Daily
Acres
Treated
in
Agriculture".

c
Baseline
inhalation
MOE
=
short­
and
intermediate­
term
NOAEL
(
2.7
mg/
kg/
day)
/
baseline
inhalation
dose
(
mg/
kg/
day)
and
represents
no
respiratory
protection.

d
80%
PPE­
R
inhalation
MOE
=
short­
and
intermediate­
term
NOAEL
(
2.7
mg/
kg/
day)
/
80
percent
PPE­
R
inhalation
dose
(
mg/
kg/
day)
and
represents
use
of
a
dust
mist
respirator.
Dose
is
calculated
using
an
80
percent
protection
factor
applied
to
baseline
inhalation
exposure
values
found
in
the
PHED
Surrogate
Exposure
Guide.
    
57
  
71
e
Engineering
control
inhalation
MOE
=
short­
and
intermediate­
term
NOAEL
(
2.7
mg/
kg/
day)
/
engineering
control
inhalation
dose
(
mg/
kg/
day)
and
represents:

1a,
1b,
1c,
1d:
closed
mixing
2a,
2b,
2c,
2d:
water
soluble
packet
enclosed
cockpit
and
4,
5,
6:
enclosed
cab
Table
7.2.2.
Cypermethrin
Long­
Term
Occupational
Handler
Summary
Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Long­
Term
Baseline
Dermal
+

Baseline
Inhalation
ARIc
Long­
Term
PPE­
Gloves
Dermal
+

Baseline
Inhalation
ARId
Long­
Term
PPEGloves
Dermal
+

Dust/
Mist
Respirator
Inhalation
ARIe
Mixer/
Loader/
Applicator
residential,
commercial
and
industrial
lawns
0.44
lb
ai/
acre
5
acre
0.71
9.1
38
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,
building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
40
gallons
0.78
10
41
Termites
applications
to
preconstruction
lumber
and
logs,

and
to
soil
under
firewood
0.041
lb
ai/
gallon
40
gallons
0.95
12
50
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,
commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
0.017
lb
ai/
gallon
40
gallons
2.3
29
120
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Low
Pressure
Handwand
(
1)
ornamental
plants;
termite
applications
to
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.008
lb
ai/
gallon
40
gallons
4.9
62
260
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,
building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
5
gallons
2.6
6.8
17
Termites:
preconstruction
lumber
and
logs,
soil
under
firewood
0.041
lb
ai/
gallon
5
gallons
3.2
8.3
21
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Paintbrush
(
2)
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,
commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
0.017
lb
ai/
gallon
5
gallons
7.8
20
51
    
58
  
71
Table
7.2.2.
Cypermethrin
Long­
Term
Occupational
Handler
Summary
Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Long­
Term
Baseline
Dermal
+

Baseline
Inhalation
ARIc
Long­
Term
PPE­
Gloves
Dermal
+

Baseline
Inhalation
ARId
Long­
Term
PPEGloves
Dermal
+

Dust/
Mist
Respirator
Inhalation
ARIe
agricultural
uncultivated
areas;
fencerows,
hedgerows;

ornamental
plants;
potting
soil,
topsoil
3.4
lb
ai/
acre
5
acres
no
baseline
dermal
data
11
18
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Handheld
Handgun
(
ORETF)

(
3)
residential,
commercial
and
industrial
lawns
0.44
lb
ai/
acre
5
acres
no
baseline
dermal
data
82
140
Mixing/
Loading/
Applying
Liquid
Concentrates
with
a
Termiticide
Injector
(
4)
Termites:
trees,
utility
poles,
fenceposts,
building
voids
0.05
lb
ai/
gallon
500
gallons
no
baseline
dermal
data
7.1
18
residential,
commercial
and
industrial
lawns
0.6
lb
ai/
acre
5
acres
no
baseline
dermal
data
0.19
0.83
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,
building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
40
gallons
no
baseline
dermal
data
0.28
1.2
fire
ant
mounds
0.033
lb
ai/
gallon
40
gallons
no
baseline
dermal
data
0.42
1.9
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,
commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
applications
to
horses
0.017
lb
ai/
gallon
40
gallons
no
baseline
dermal
data
0.82
3.7
Mixing/
Loading/
Applying
Wettable
Powders
with
a
Low
Pressure
Handwand
(
5)
ornamental
plants;
termite
applications
to
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.008
lb
ai/
gallon
40
gallons
no
baseline
dermal
data
1.7
7.8
Termites
applications
to
soil
and
sides
of
buildings
near
to
ground,
building
perimeters,
masonry
voids,
and
standing
wood
in
uninhabited
areas
at
residential,
commercial
and
industrial
sites
0.05
lb
ai/
gallon
5
gallons
2.6
6.8
17
Termites:
preconstruction
lumber
and
logs,
soil
under
firewood
0.041
lb
ai/
gallon
5
gallons
3.2
8.3
21
Mixing/
Loading/
Applying
Wettable
Powders
with
a
Paintbrush
(
using
PHED
liquid
paintbrush
data)
(
6)
Non­
termite
applications
to
indoor
and
outdoor
surfaces
at
residential,
commercial
and
industrial
sites,
animal
premises,
and
greenhouses;
0.017
lb
ai/
gallon
5
gallons
7.8
20
51
    
59
  
71
Table
7.2.2.
Cypermethrin
Long­
Term
Occupational
Handler
Summary
Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
unit)
Amount
Handled
Dailyb
Long­
Term
Baseline
Dermal
+

Baseline
Inhalation
ARIc
Long­
Term
PPE­
Gloves
Dermal
+

Baseline
Inhalation
ARId
Long­
Term
PPEGloves
Dermal
+

Dust/
Mist
Respirator
Inhalation
ARIe
agricultural
uncultivated
areas;
fencerows,
hedgerows;

ornamental
plants;
potting
soil,
topsoil
3.4
lb
ai/
acre
5
acres
no
baseline
dermal
data
0.55
2.3
Mixing/
Loading/
Applying
Wettable
Powders
with
a
Handheld
Handgun
(
ORETF)
(
7)
residential,
commercial
and
industrial
lawns
0.6
lb
ai/
acre
5
acres
no
baseline
dermal
data
3.1
13
agricultural
uncultivated
areas;
fencerows,
hedgerows;

ornamental
plants;
potting
soil,
topsoil
3.4
lb
ai/
acre
5
acres
no
baseline
dermal
data
3.9
9.7
Mixing/
Loading/
Applying
WSB
Formulations
with
a
Handheld
Handgun
(
ORETF)
(
8)
residential,
commercial
and
industrial
lawns
0.6
lb
ai/
acre
5
acres
no
baseline
dermal
data
22
55
Footnotes
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
Cypermethrin.

b
Amount
handled
per
day
values
are
EPA
estimates
of
acreage
treated
or
gallons
applied
based
on
Exposure
SAC
Policy
#
9
"
Standard
Values
for
Daily
Acres
Treated
in
Agriculture".

c
Aggregate
Risk
Index
=
1/{[
1/(
Baseline
Dermal
MOE/
Dermal
UF­
100)]
+
[
1/(
Baseline
Inhalation
MOE/
Inhalation
UF­
300)]}
where
an
ARI
greater
than
1
is
considered
acceptable
d
Aggregate
Risk
Index
=
1/{[
1/(
PPE­
gloves
Dermal
MOE/
Dermal
UF­
100)]
+
[
1/(
Baseline
Inhalation
MOE/
Inhalation
UF­
300)]}
where
an
ARI
greater
than
1
is
considered
acceptable.

e
Aggregate
Risk
Index
=
1/{[
1/(
PPE­
gloves
Dermal
MOE/
Dermal
UF­
100)]
+
[
1/(
Dust/
Mist
Respirator
Inhalation
MOE/
Inhalation
UF
­
300)]}
where
an
ARI
greater
than
1
is
considered
acceptable.
Table
7.2.3:
Zeta­
Cypermethrin
Occupational
Handler
Short­
and
Intermediate­
Term
Risks
Exposure
Scenario
Crop
or
Target
Application
Ratea
Area
Treated
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
Mixer/
Loader
Alfalfa,
Alfalfa
grown
for
seed,
Corn,
sweet,
field,
pop,
and
field
grown
for
seed;
Cotton
(
foliar
use),
Rice,
Soybeans,

Wheat,
and
Triticale
0.05
lb
ai/
acre
1200
acres
2,600
13,000
38,000
Mixing/
Loading
Liquid
Concentrates
for
Aerial
Applications
(
1a)
Leafy
Brassica
Greens,
Head
and
Stem
Brassica
Vegetables,

Bulb
Vegetables,
Fruiting
Vegetables
(
except
cucurbits),
Leafy
Vegetables
(
except
Brassica),
Succulent
Edible
Podded
Peas,
0.05
lb
ai/
acre
350
acres
9,000
45,000
130,000
    
60
  
71
Table
7.2.3:
Zeta­
Cypermethrin
Occupational
Handler
Short­
and
Intermediate­
Term
Risks
Exposure
Scenario
Crop
or
Target
Application
Ratea
Area
Treated
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
Succulent
Edible
Podded
Beans,
Head
Lettuce,
Pecans,
Grain
Sorghum
and
Millet,
Sugarbeets,
Sugarcane
Alfalfa,
Alfalfa
grown
for
seed,
Corn,
sweet,
field,
pop,
and
field
grown
for
seed;
Cotton
(
foliar
use),
Rice,
Soybeans,

Wheat,
and
Triticale
0.05
lb
ai/
acre
350
acres
9,000
45,000
130,000
Mixing/
Loading
Liquid
Concentrates
for
Chemigation
Applications
(
1b)
Leafy
Brassica
Greens,
Head
and
Stem
Brassica
Vegetables,

Bulb
Vegetables,
Fruiting
Vegetables
(
except
cucurbits),
Leafy
Vegetables
(
except
Brassica),
Succulent
Edible
Podded
Peas,

Succulent
Edible
Podded
Beans,
Head
Lettuce,
Pecans,
Grain
Sorghum
and
Millet,
Sugarbeets,
Sugarcane
0.05
lb
ai/
acre
350
acres
9,000
45,000
130,000
Alfalfa,
Alfalfa
grown
for
seed,
Corn,
sweet,
field,
pop,
and
field
grown
for
seed;
Cotton
(
foliar
use),
Rice,
Soybeans,

Wheat,
and
Triticale
0.05
lb
ai/
acre
200
acres
16,000
79,000
230,000
Mixing/
Loading
Liquid
Concentrates
for
Groundboom
Applications
(
1c)
Leafy
Brassica
Greens,
Head
and
Stem
Brassica
Vegetables,

Bulb
Vegetables,
Fruiting
Vegetables
(
except
cucurbits),
Leafy
Vegetables
(
except
Brassica),
Succulent
Edible
Podded
Peas,

Succulent
Edible
Podded
Beans,
Head
Lettuce,
Grain
Sorghum
and
Millet,
Sugarbeet,
Sugarcane
0.05
lb
ai/
acre
80
acres
39,000
200,000
570,000
Mixing/
Loading
Liquid
Concentrates
for
Airblast
Applications
(
1d)
Pecans
0.05
lb
ai/
acre
40
acres
79,000
390,000
1,100,000
Loading
Dusts
into
Mechanical
Duster
or
Dust
Bags
(
using
PHED
mixing/
loading
wettable
powders
data)

(
2)
Livestock
(
beef
&
dairy
cattle,
sheep,
goats,
horses)
0.000094
lb
ai/
animal
1000
animals
47,000
230,000
Not
Feasible
Applicator
    
61
  
71
Table
7.2.3:
Zeta­
Cypermethrin
Occupational
Handler
Short­
and
Intermediate­
Term
Risks
Exposure
Scenario
Crop
or
Target
Application
Ratea
Area
Treated
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
Alfalfa,
Alfalfa
grown
for
seed,
Corn,
sweet,
field,
pop,
and
field
grown
for
seed;
Cotton
(
foliar
use),
Rice,
Soybeans,

Wheat,
and
Triticale
0.05
lb
ai/
acre
1200
acres
No
Data
No
Data
46,000
Applying
Sprays
via
Aerial
Equipment
(
3)
Leafy
Brassica
Greens,
Head
and
Stem
Brassica
Vegetables,

Bulb
Vegetables,
Fruiting
Vegetables
(
except
cucurbits),
Leafy
Vegetables
(
except
Brassica),
Succulent
Edible
Podded
Peas,

Succulent
Edible
Podded
Beans,
Head
Lettuce,
Pecans,
Grain
Sorghum
and
Millet,
Sugarbeet,
Sugarcane
0.05
lb
ai/
acre
350
acres
No
Data
No
Data
160,000
Alfalfa,
Alfalfa
grown
for
seed,
Corn,
sweet,
field,
pop,
and
field
grown
for
seed;
Cotton
(
foliar
use),
Rice,
Soybeans,

Wheat,
and
Triticale
0.05
lb
ai/
acre
200
acres
26,000
130,000
440,000
Applying
Sprays
via
Groundboom
Equipment
(
4)
Leafy
Brassica
Greens,
Head
and
Stem
Brassica
Vegetables,

Bulb
Vegetables,
Fruiting
Vegetables
(
except
cucurbits),
Leafy
Vegetables
(
except
Brassica),
Succulent
Edible
Podded
Peas,

Succulent
Edible
Podded
Beans,
Head
Lettuce,
Grain
Sorghum
and
Millet,
Sugarbeet,
Sugarcane
0.05
lb
ai/
acre
80
acres
64,000
320,000
1,100,000
Applying
Sprays
via
Airblast
Equipment
(
5)
Pecans
0.05
lb
ai/
acre
40
acres
21,000
110,000
210,000
Applying
Dusts
via
Mechanical
Duster
(
6)
Livestock
(
beef
&
dairy
cattle,
sheep,
goats,
horses)
0.000094
lb
ai/
animal
1000
animals
No
Data
No
Data
No
Data
Flagger
Flagging
for
Aerial
Spray
Applications
(
7)
Alfalfa,
Alfalfa
grown
for
seed,
Corn,
sweet,
field,
pop,
and
field
grown
for
seed;
Cotton
(
foliar
use),
Rice,
Soybeans,

Wheat,
Triticale,
Leafy
Brassica
Greens,
Head
and
Stem
Brassica
Vegetables,
Bulb
Vegetables,
Fruiting
Vegetables
(
except
cucurbits),
Leafy
Vegetables
(
except
Brassica),

Succulent
Edible
Podded
Peas,
Succulent
Edible
Podded
Beans,
Head
Lettuce,
Pecans,
Grain
Sorghum
and
Millet,

Sugarbeet,
Sugarcane
0.05
lb
ai/
acre
350
acres
31,000
150,000
1,500,000
    
62
  
71
Table
7.2.3:
Zeta­
Cypermethrin
Occupational
Handler
Short­
and
Intermediate­
Term
Risks
Exposure
Scenario
Crop
or
Target
Application
Ratea
Area
Treated
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
Mixer/
Loader/
Applicator
Indoor
surfaces
0.0044
lb
ai/
gallon
40
gallons
36,000
180,000
Not
Feasible
Residential
Lawns
and
Turfgrass
at
Commercial
Sites
0.3
lb
ai/
acre
5
acres
4,200
21,000
Not
Feasible
Mixing/
Loading/

Applying
Liquid
Concentrates
with
Low
Pressure
Handwand
(
PHED)
(
8)
Outdoor
surfaces
0.001
lb
ai/
gallon
40
gallons
160,000
790,000
Not
Feasible
residential
lawns
0.3
lb
ai/
acre
5
acres
70,000
350,000
Not
Feasible
Mixing/
Loading/

Applying
Liquid
Concentrates
with
a
Handgun
Sprayer
(
LCO
ORETF
data)

(
9)
outdoor
surfaces,
surfaces
of
buildings,
porches,
screens,

window
frames,
eaves,
patios,
lawn
area
adjacent
to
or
around
private
homes,
duplexes,
townhouses,
condominiums,
house
trailers
apartment
complexes,
carports,
garages,
fence
lines,

storage
sheds,
barns,
and
other
residential
structures
plus
commercial,
industrial,
institutional
buildings,
vegetation,

refuse
dumps,
garages,
and
other
outdoor
surfaces
0.4356
lb
ai/
acre
5
acres
48,000
240,000
Not
Feasible
Applying
Dusts
via
Shaker
Can
(
MRID
444598­
01)
(
10)
Livestock
(
beef
&
dairy
cattle,
sheep,
goats,
horses)
0.000094
lb
ai/
animal
100
animals
32,000
1,600,000
Not
Feasible
Mixing/
Loading/

Applying
Liquid
Concentrates
with
a
Watering
Can
(
using
ORETF
residential
hose­
end
data)
(
12)
outdoor
surfaces
(
ant
mounds)
0.006
lb
ai/
mound
40
mounds
46,000
230,000
Not
Feasible
Mixing/
Loading/

Applying
Liquid
Concentrates
with
a
Paint
Brush
(
13)
outdoor
surfaces
(
general)
0.001
lb
ai/
gallon
5
gallons
140,000
680,000
Not
Feasible
    
63
  
71
Table
7.2.3:
Zeta­
Cypermethrin
Occupational
Handler
Short­
and
Intermediate­
Term
Risks
Exposure
Scenario
Crop
or
Target
Application
Ratea
Area
Treated
Dailyb
Baseline
Inhalation
MOEc
Dust/
Mist
Respirator
Inhalation
MOEd
Engineering
Control
Inhalation
MOEe
livestock
(
cattle)
0.004
lb
ai/
2
ear
tags/
cattle
100
&

1000
cattle
No
Data
No
Data
Not
Feasible
Applying
Ready
to
Use
Ear­
Tags
(
14)
livestock
(
cattle)
0.003
lb
ai/
1
ear
tag/
cattle
100
&

1000
cattle
No
Data
No
Data
Not
Feasible
Loading
Dusts
into
Self­
Applying
Dust
Bags
(
using
PHED
mixing/
loading
wettable
powders
data)

(
15)
Livestock
(
beef
&
dairy
cattle,
sheep,
goats,
horses)
0.000094
lb
ai/
animal
1000
animals
47,000
230,000
Not
Feasible
Footnotes
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
Zeta­
Cypermethrin.

b
Amount
handled
per
day
values
are
HED
estimates
of
acres,
square
feet,
or
cubic
feet
treated
or
gallons
applied
based
on
Exposure
SAC
SOP
#
9
 
Standard
Values
for
Daily
Acres
Treated
in
Agriculture, 
industry
sources,
and
HED
estimates.

c
Baseline
inhalation:
no
respirator.

d
PPE
inhalation:
assumes
a
dust/
mist
removing
quarter­
face
style
respirator
providing
an
80%
protection
factor
(
PF5)

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

Table
7.2.4:
Zeta­
cypermethrin
Long­
Term
Occupational
Handler
Summary
Exposure
Scenario
Crop
or
Target
Applicati
on
Ratea
Area
Treated
Dailyb
Long
term
Baseline
Dermal
+

Baseline
Inhalation
ARIc
Long
term
PPE­
Gloves
Dermal
+

Baseline
Inhalation
ARId
Long
term
PPEGloves
Dermal
+

Dust/
Mist
Respirator
Inhalation
ARIe
Mixer/
Loader/
Applicator
    
64
  
71
Table
7.2.4:
Zeta­
cypermethrin
Long­
Term
Occupational
Handler
Summary
Exposure
Scenario
Crop
or
Target
Applicati
on
Ratea
Area
Treated
Dailyb
Long
term
Baseline
Dermal
+

Baseline
Inhalation
ARIc
Long
term
PPE­
Gloves
Dermal
+

Baseline
Inhalation
ARId
Long
term
PPEGloves
Dermal
+

Dust/
Mist
Respirator
Inhalation
ARIe
Indoor
surfaces
and
Outdoor
surfaces
(
outdoor
rate
supplied
by
Registrant)
0.0044
lb
ai/
gallon
40
gallons
0.095
110
470
Residential
Lawns
and
Turfgrass
at
Commercial
Sites
(
Rate
supplied
by
Registrant)
0.3
lb
ai/
acre
5
acres
0.011
13
55
Mixing/
Loadin
g/
Applying
Liquid
Concentrates
with
Low
Pressure
Handwand
(
PHED)
Outdoor
surfaces
(
rate
from
label)
0.001
lb
ai/
gallon
40
gallons
0.42
500
2100
residential
lawns
0.3
lb
ai/
acre
5
acres
No
Baseline
Dermal
Data
120
210
Mixing/
Loadin
g/
Applying
Liquid
Concentrates
with
a
Handgun
Sprayer
(
LCO
ORETF
data)
outdoor
surfaces,
surfaces
of
buildings,
porches,

screens,
window
frames,
eaves,
patios,
lawn
area
adjacent
to
or
around
private
homes,
duplexes,

townhouses,
condominiums,
house
trailers
apartment
complexes,
carports,
garages,
fence
lines,
storage
sheds,
barns,
and
other
residential
structures
plus
commercial,
industrial,

institutional
buildings,
vegetation,
refuse
dumps,

garages,
and
other
outdoor
surfaces
0.4356
lb
ai/
acre
5
acres
No
Baseline
Dermal
Data
83
140
Mixing/
Loadin
g/
Applying
Liquid
Concentrates
outdoor
surfaces
(
ant
mounds)
0.006
lb
ai/
mound
40
mounds
1.2
No
PPE
Dermal
Data
No
PPE
Dermal
Data
    
65
  
71
with
a
Watering
Can
(
using
ORETF
residential
hose­
end
data)

Mixing/
Loadin
g/
Applying
Liquid
Concentrates
with
a
Paint
Brush
outdoor
surfaces
(
general)
(
rate
from
label)
0.001
lb
ai/
gallon
5
gallons
1.9
340
860
Footnotes
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
zeta­
cypermethrin.

b
Amount
handled
per
day
values
are
HED
estimates
of
acres,
square
feet,
or
cubic
feet
treated
or
gallons
applied
based
on
Exposure
SAC
SOP
#
9
 
Standard
Values
for
Daily
Acres
Treated
in
Agriculture, 
industry
sources,
and
HED
estimates.

c
Baseline
inhalation:
no
respirator.

d
PPE
inhalation:
assumes
a
dust/
mist
removing
quarter­
face
style
respirator
providing
an
80%
protection
factor
e
Eng
Controls
Inhalation:
Closed
mixing/
loading
system,
enclosed
cab,
or
enclosed
cockpit.
    
66
  
71
8.0
DATA
NEEDS
AND
LABEL
REQUIREMENTS
Toxicology
·
None.

Product
and
Residue
Chemistry
Data
Requirements
·
The
registrant
has
addressed
the
product
chemistry
deficiencies
identified
in
the
phase
2
risk
assessment
document.
Upon
completion
of
review
of
the
submitted
data,
HED
will
comment
on
any
remaining
outstanding
data
requirements
for
product
chemistry.

·
Needed
label
changes
pertain
to
the
following:
1)
minimum
retreatment
intervals,
2)
minimum
aerial
application
volumes,
and
3)
impractical
cotton
forage
grazing/
feeding
restrictions.
The
registrant
has
agreed
to
make
these
changes.
Upon
receipt
of
the
updated
label,
this
data
requirement
will
be
satisfied.

Occupational
&
Residential
·
The
residential
postapplication
residential
assessment
for
cypermethrin
is
based
on
limited
chemical­
specific
studies.
Additional
data
could
potentially
be
used
to
refine
risk
estimates
for
the
other
settings
such
as
TTR
data
which
are
more
appropriate
for
hand­
tomouth
and
object­
to­
mouth
exposures.
    
67
  
71
9.0
TOLERANCE
REASSESSMENT
The
tolerances
listed
in
40
CFR
§
180.418(
a)(
1)
are
expressed
in
terms
of
residues
of
cypermethrin
per
se
[(
±
)
­
alpha­
cyano­(
3­
phenoxyphenyl)
methyl
[(
±
)
­
cis,
trans­
3(
2,2­
dichloroethenyl)­
2,2­
dimethylcyclopropanecarboxylate]],
while
those
listed
in
40
CFR
§
180.418(
a)(
2)
are
expressed
in
terms
of
residues
of
zeta­
cypermethrin
[(
S­
cyano­(
3­
phenoxyphenyl)
methyl
[(
±
)
­
cis,
trans­
3(
2,2­
dichloroethenyl)­
2,2­
dimethylcyclopropanecarboxylate]]
and
its
inactive
R­
isomers.
The
HED
MARC
has
determined
that
the
current
tolerance
expression
for
plant
and
livestock
commodities
is
appropriate.
Because
the
analytical
enforcement
method
does
not
distinguish
between
cypermethrin
and
zeta­
cypermethrin,
all
tolerance
levels
for
livestock
commodities
should
be
the
same
for
the
racemic
and
enriched
isomers.
In
light
of
label
restrictions
and
the
different
total
application
rates
between
formulations
containing
cypermethrin
and
zetacypermethrin
different
tolerance
levels
may
be
appropriate
for
some
plants,
such
as
green
onions.

Tolerances
Listed
Under
40
CFR
§
180.418(
a)(
1):

Plant
commodity
tolerances:
Sufficient
field
trial
data
are
available
to
ascertain
the
adequacy
of
the
established
tolerances
listed
in
40
CFR
§
180.418
for
the
following
plant
commodities:
head
and
stem
Brassica
subgroup;
leafy
greens
Brassica
subgroup;
undelinted
cottonseed;
head
lettuce;
bulb
onion;
green
onion;
and
pecans.
For
the
purposes
of
tolerance
reassessment,
the
existing
field
trial
data
for
these
RACs
have
been
re­
evaluated.
With
the
exception
of
head
lettuce,
the
data
suggest
that
the
existing
tolerance
levels
for
all
plant
commodities
are
appropriate,
and
no
increase
or
decrease
in
levels
are
warranted.
Based
on
acceptable
field
trial
data
for
head
lettuce,
the
established
tolerance
for
this
commodity
should
be
lowered
from
10
ppm
to
4.0
ppm.
The
available
data
indicate
that
the
maximum
residue
of
cypermethrin
found
in
head
lettuce
following
applications
of
a
representative
cypermethrin
formulation,
according
to
the
maximum
registered
patterns,
was
3.4
ppm.

Although
a
tolerance
for
garlic
has
not
been
established,
the
existing
tolerance
for
bulb
onions
will
cover
the
registered
uses
of
cypermethrin
on
garlic,
as
permitted
according
to
40
CFR
§
180.1(
h).

Livestock
commodity
tolerances:
An
acceptable
ruminant
feeding
study
is
available
to
ascertain
the
adequacy
of
the
established
tolerances
listed
in
40
CFR
§
180.418(
a)(
1)
for
the
following
livestock
commodities:
meat,
fat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses
and
sheep.
Also,
an
acceptable
poultry
feeding
study
is
available
to
determine
the
need
for
tolerances
in/
on
poultry
commodities.
    
68
  
71
Tolerances
That
Need
To
Be
Proposed
Under
40
CFR
§
180.418(
a)(
1):

Based
on
the
recently
submitted
magnitude
of
the
residue
data
for
cotton
gin
byproducts,
a
tolerance
level
of
11
ppm
is
appropriate
for
this
commodity.
This
level
was
determined
through
use
of
the
tolerance
spreadsheet
calculator.
Based
on
the
poultry
feeding
study
and
dietary
burden
and
Codex
considerations,
HED
recommends
that
a
tolerance
level
of
0.05
ppm
be
established
for
cypermethrin
residues
in/
on
egg;
poultry,
fat;
and
poultry,
meat.

Tolerances
That
Need
To
Be
Changed
Under
40
CFR
§
180.418(
a)(
2):

As
discussed
previously,
tolerance
levels
for
livestock
commodities
should
be
the
same
for
cypermethrin
and
zeta­
cypermethrin.
Comparison
of
the
dietary
burden
calculated
for
swine
shows
that
it
is
approximately
10X
lower
than
that
for
cattle.
Accordingly,
lower
tolerance
levels
are
appropriate
for
hog
commodities.
Thus,
the
present
data
supports
the
following
changes
to
hog
tolerances:
1)
reduce
the
current
tolerance
level
of
1.0
ppm
for
hog,
fat
to
0.10
ppm,
2)
reduce
the
current
tolerance
level
of
0.2
ppm
for
hog,
meat
to
0.05
ppm,
and
3)
remove
the
current
tolerance
level
of
0.05
ppm
for
hog,
meat
byproducts.
In
addition,
the
current
tolerance
level
of
10.00
ppm
for
lettuce,
head
may
be
removed
since
this
RAC
is
already
included
in
the
crop
group
4
listing.
Finally,
the
poultry,
meat
byproducts
tolerance
level
of
0.05
ppm
should
be
removed
as
the
present
analysis
shows
expected
residues
to
be
so
low
that
a
tolerance
is
not
necessary
[
40
CFR
§
180.6(
a)(
3)].

A
summary
of
cypermethrin
tolerance
reassessments
is
presented
in
Table
9.1.

Table
9.1.
Tolerance
Reassessment
Summary
for
Cypermethrin.

Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/
Correct
Commodity
Definition
Tolerances
listed
under
40
CFR
180.418(
a)(
1):

Brassica,
head
and
stem
2.0
2.0
[
Brassica,
head
and
stem,
subgroup]

Brassica,
leafy
14.0
14.0
[
Brassica,
leafy
greens,
subgroup]

Cattle,
fat
0.05
1.0
Based
on
a
MTDB
of
18
ppm
Cattle,
meat
0.05
0.20
Based
on
a
MTDB
of
18
ppm
Harmonizes
with
Codex
MRL
Cattle,
mbyp
0.05
0.05
Based
on
a
MTDB
of
18
ppm
[
Cattle,
meat
byproducts]

Cottonseed
0.5
0.50
[
Cotton,
undelinted
seed]

Goats,
fat
0.05
1.0
Based
on
a
MTDB
of
18
ppm
[
Goat,
fat]

Goats,
meat
0.05
0.20
Based
on
a
MTDB
of
18
ppm.
[
Goat,
meat]

Goats,
mbyp
0.05
0.05
Based
on
a
MTDB
of
18
ppm.
[
Goat,
meat
byproducts]

Hogs,
fat
0.05
0.10
Based
on
a
MTDB
of
1.8
ppm
    
69
  
71
Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/
Correct
Commodity
Definition
[
Hog,
fat]

Hogs,
meat
0.05
0.05
Based
on
a
MTDB
of
1.8
ppm
[
Hog,
meat]

Hogs,
mbyp
0.05
 
Based
on
a
MTDB
of
1.8
ppm
Residue
data
support
removal
of
tolerance.

Horses,
fat
0.05
1.0
Based
on
a
MTDB
of
18
ppm
[
Horse,
fat]

Horses,
meat
0.05
0.20
Based
on
a
MTDB
of
18
ppm
[
Horse,
meat]

Horses,
mbyp
0.05
0.05
Based
on
a
MTDB
of
18
ppm
[
Horse,
meat
byproducts]

Lettuce,
head
10.0
4.0
Residue
data
support
reduction
of
tolerance.

Milk
0.05
2.5
Based
on
a
MTDB
of
18
ppm
[
Milk,
fat
(
reflecting
0.10
in
whole
milk)]

Onions,
bulb
0.1
0.10
[
Onion,
bulb]

Onions,
green
6.0
6.0
Residue
data
support
a
tolerance
level
of
3.0
ppm
for
zeta­
cypermethrin
/
[
Onion,
green]

Pecans
0.05
0.05
Sheep,
fat
0.05
1.0
Based
on
a
MTDB
of
18
ppm
Sheep,
meat
0.05
0.20
Based
on
a
MTDB
of
18
ppm
Harmonizes
with
Codex
MRL
Sheep,
mbyp
0.05
0.05
Based
on
a
MTDB
of
18
ppm
[
Sheep,
meat
byproducts]

Tolerances
That
Need
To
Be
Proposed
under
40
CFR
180.418(
a)(
1):

Cotton
gin
byproducts
­­
11
Based
on
new
data
submitted.

Egg
 
0.05
Based
on
a
MTDB
of
1.4
ppm
Poultry,
fat
 
0.05
Based
on
a
MTDB
of
1.4
ppm
Poultry,
meat
 
0.05
Harmonizes
with
Codex
MRL
Tolerances
That
Need
To
Be
Changed
under
40
CFR
180.418(
a)(
2):

Hog,
fat
1.0
0.10
Based
on
a
MTDB
of
1.8
ppm
Hog,
meat
0.2
0.05
Based
on
a
MTDB
of
1.8
ppm
Hog,
meat
byproducts
0.05
None
Based
on
a
MTDB
of
1.8
ppm
Lettuce,
head
10.00
None
Covered
by
Vegetable,
leafy,
except
Brassica,
group
04
Poultry,
meat
byproducts
0.05
None
Based
on
a
MTDB
of
1.4
ppm
    
70
  
71
