Document ID: EPA-HQ-OPP-2005-0293-0029
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-16T04:00Z

United
States
Prevention,
Pesticides
EPA
OPP­
2005­
0293
Environmental
Protection
And
Toxic
Substances
June
14,
2006
Agency
(
7508C)
_________________________________________________________________

Reregistration
Eligibility
Decision
for
Cypermethrin
List
B
Case
No.
2130
Reregistration
Eligibility
Decision
(
RED)
Document
for
Cypermethrin
Approved
by:
.
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
.
Page
3
of
79
TABLE
OF
CONTENTS
I.
Introduction.....................................................................................................................
13
II.
Chemical
Overview
.....................................................................................................
14
A.
Regulatory
History
......................................................................................................
14
B.
Chemical
Identification...............................................................................................
15
C.
Use
Profiles
..................................................................................................................
16
III.
Summary
of
Cypermethrin
Risk
Assessments
...........................................................
17
A.
Human
Health
Risk
Assessment
.................................................................................
18
1.
Toxicity
....................................................................................................................
18
2.
FQPA
Safety
Factor
................................................................................................
20
3.
Dermal
Absorption..................................................................................................
21
4.
Dietary
Exposure
.....................................................................................................
21
5.
Drinking
Water
Exposure
.......................................................................................
22
6.
Residential
Exposure
and
Risk
...............................................................................
22
7.
Aggregate
Exposure
and
Risk
(
food,
drinking
water,
and
residential)
.................
24
8.
Occupational
Exposure
and
Risk............................................................................
25
9.
Human
Incident
Data..............................................................................................
27
B.
Environmental
Risk
Assessment.................................................................................
28
1.
Environmental
Fate
and
Transport
........................................................................
28
2.
Ecological
Risk.........................................................................................................
29
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
..............
40
A.
Determination
of
Reregistration
Eligibility
and
Tolerance
Reassessment................
40
B.
Public
Comments
and
Responses................................................................................
40
C.
Regulatory
Position
.....................................................................................................
41
1.
Food
Quality
Protection
Act
Findings
....................................................................
41
2.
Endocrine
Disruptor
Effects
...................................................................................
42
3.
Cumulative
Risks.....................................................................................................
42
D.
Tolerance
Reassessment
Summary.............................................................................
43
E.
Regulatory
Rationale...................................................................................................
44
1.
Human
Health
Risk
Mitigation...............................................................................
45
2.
Environmental
Risk
Mitigation
..............................................................................
47
3.
Benefits
of
Cypermethrin
Use
and
Available
Alternatives
....................................
55
V.
What
Registrants
Need
to
Do
.........................................................................................
55
A.
Manufacturing
Use
Products
......................................................................................
56
1.
Additional
Generic
Data
Requirements
.................................................................
56
2.
Labeling
Requirements
...........................................................................................
56
3.
Spray
Drift
Management
........................................................................................
56
B.
End­
Use
Products
....................................................................................................
56
Appendix
A.
Uses
of
Cypermethrin
Eligible
for
Reregistration
...........................................
77
Appendix
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision...........................................................................................................
77
Appendix
C.
Technical
Support
Documents.........................................................................
78
Appendix
D.
Citations
Considered
to
be
Part
of
the
Data
Base
Supporting
the
Reregistration
Eligibility
Decision
.........................................................................................
79
Page
4
of
79
Cypermethrin
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs:

Environmental
Fate
and
Effects
Risk
Assessment
Miachel
Rexrode
José
Luis
Meléndez
Health
Effects
Risk
Assessment
William
H.
Donovan
Pamela
M.
Hurley
John
Doherty
Seyed
Tadayon
Biological
and
Economic
Analysis
Division
Alan
Halvorson
Registration
George
LaRocca
Risk
Management
Yan
Donovan
Véronique
LaCapra
Dirk
V.
Helder
Page
5
of
79
Glossary
of
Terms
and
Abbreviations
AGDCI
Agricultural
Data
Call­
In
ai
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
BCF
Bioconcentration
Factor
CFR
Code
of
Federal
Regulations
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DWLOC
Drinking
Water
Level
of
Comparison.
EC
Emulsifiable
Concentrate
Formulation
EDWC
Estimated
Drinking
Water
Concentration
EEC
Estimated
Environmental
Concentration
EPA
Environmental
Protection
Agency
EUP
End­
Use
Product
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
GLN
Guideline
Number
HAFT
Highest
Average
Field
Trial
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOC
Level
of
Concern
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
Fg/
g
Micrograms
Per
Gram
Fg/
L
Micrograms
Per
Liter
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MUP
Manufacturing­
Use
Product
NA
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
NOAEC
No
Observed
Adverse
Effect
Concentration
NOAEL
No
Observed
Adverse
Effect
Level
Page
6
of
79
OP
Organophosphate
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SAP
Science
Advisory
Panel
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
TGAI
Technical
Grade
Active
Ingredient
TRR
Total
Radioactive
Residue
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UF
Uncertainty
Factor
UV
Ultraviolet
WPS
Worker
Protection
Standard
Page
7
of
79
Executive
Summary
This
document
presents
EPA's
decision
regarding
the
reregistration
eligibility
of
the
registered
uses
of
cypermethrin.
The
Agency
has
conducted
human
health
and
ecological
risk
assessments
based
on
reviews
of
the
database
supporting
use
patterns
of
the
currently
registered
cypermethrin
products.
This
document
summarizes
these
risk
assessments
and
describes
the
mitigation
measures
needed
to
address
the
identified
risks.

Cypermethrin
is
an
insecticide
used
both
in
agricultural
and
non­
agricultural
settings.
Total
cypermethrin
use
in
the
United
States
is
approximately
1.0
million
pounds
of
active
ingredient
(
a.
i.)
per
year.
Approximately
140,000
pounds
a.
i.
are
used
in
agricultural
crops,
mainly
on
cotton
(
110,000
pounds),
with
minor
uses
on
pecans,
peanuts,
broccoli
and
sweet
corn.
Treatment
of
cattle
and
other
livestock
accounts
for
approximately
1000
pounds
a.
i.
per
year.
The
great
majority
of
cypermethrin
use
occurs
in
non­
agricultural
settings,
including
a
wide
range
of
commercial,
industrial,
and
residential
sites.
Indoor
pest
control
­
mainly
for
control
of
ants,
cockroaches,
and
fleas
­
accounts
for
about
110,000
pounds
a.
i.,
while
outdoor
structural,
perimeter,
and
turf
uses
for
control
of
subterranean
termites
and
other
insect
pests
accounts
for
nearly
750,000
pounds
a.
i.
In
residential
settings,
cypermethrin
can
be
applied
both
by
professional
applicators
and
by
residential
users.

Cypermethrin
was
first
registered
in
1984
by
FMC
Corporation,
who
also
subsequently
registered
the
isomer
enriched
zeta­
cypermethrin
in
1992.
Current
technical
registrants
for
cypermethrin
included
FMC,
Syngenta,
United
Phosphorus
International,
and
Valent
BioSciences.
Data
for
the
two
active
ingredients
is
considered
interchangeable.
Since
zetacypermethrin
was
registered
after
1984,
only
cypermethrin
is
subject
to
reregistration.
Cypermethrin
is
on
reregistration
List
B;
thus
no
Registration
Standard
was
completed.
Data
call­
ins
(
DCIs)
for
cypermethrin
were
issued
in
1991
for
basic
toxicology
and
residue
chemistry
data,
and
in
1995
for
handler
exposure
and
worker
re­
entry
data.
Cypermethrin
is
one
of
nine
synthetic
pyrethroids
registered
on
cotton,
represented
by
the
Pyrethroid
Working
Group
(
PWG),
that
are
considered
to
be
conditionally
registered
pending
the
development
and
review
of
data
related
to
aquatic
toxicity.
EPA
will
make
every
effort
to
coordinate
the
implementation
of
its
reregistration
eligibility
decision
provisions
and
labeling
for
cypermethrin
with
the
ongoing
efforts
of
the
PWG.

The
Agency's
human
health
effects
and
environmental
fate
risk
assessment
for
cypermethrin
included
the
assessment
for
zeta­
cypermethrin
as
well,
since
zeta­
cypermethrin
is
an
Senantiomer
enriched
formulation
of
cypermethrin,
which
is
not
distinguished
from
cypermethrin
by
the
analytical
enforcement
method,
and
the
toxicological
endpoints
are
the
same
for
both
cypermethrin
and
zeta­
cypermethrin.

Human
Health
Risk
Dietary
Exposure
(
food
only)
Refined
acute
(
probabilistic)
and
chronic
dietary
exposure
assessments
were
performed
in
order
to
determine
the
dietary
(
food
only)
exposure
and
risk
estimates
which
result
from
the
use
of
cypermethrin
and
zeta­
cypermethrin
in/
on
all
registered
crops.
Actual
residues
from
USDA
PDP
Page
8
of
79
monitoring
data
(
collected
during
1994,
1996,
1999,
and
2001),
estimated
percent
crop
treated
information,
and
processing
factors,
where
available,
were
used.
For
acute
exposure,
the
most
highly
exposed
population
subgroup
was
children
1­
2
years
old
at
6.1%
of
the
aPAD
at
the
99.9th
percentile.
For
chronic
exposure,
the
most
highly
exposed
population
subgroup
was
children
1­
2
years
old
at
0.2%
of
the
cPAD.
Dietary
exposures
(
both
acute
and
chronic)
estimates
are
below
the
Agency's
level
of
concern
for
the
general
U.
S.
population
and
all
population
subgroups.

Drinking
Water
Exposure
The
Estimated
Drinking
Water
Concentrations
(
EDWCs)
for
cypermethrin
were
calculated
using
PRZM/
EXAMS
model
(
Tier
II
),
based
on
the
highest
seasonal
application
rate
(
0.6
lb
a.
i./
A
on
cotton).
The
estimated
acute
drinking
water
concentration
in
surface
water
is
1.04
ppb,
and
the
estimated
chronic
drinking
water
concentration
in
surface
water
is
0.013
ppb.
The
SCI­
GROW
model
was
used
to
generate
the
EDWC
for
groundwater.
The
groundwater
EDWC
for
both
acute
and
chronic
exposures
is
0.0036
ppb.

Residential
Exposure
and
Risk
Residential
handler
inhalation
risks
are
below
EPA's
level
of
concern
for
all
non­
occupational
handler
scenarios.
No
short­
term
dermal
exposures
or
risks
were
assessed
for
residential
handlers
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
zetacypermethrin
Therefore,
no
intermediate­
or
long­
term
risks
were
assessed.

Residential
/
non­
dietary
post­
application
exposure
to
adults
was
assessed
via
the
inhalation
route,
since
no
effects
were
observed
in
the
dermal
exposure
study.
Exposure
to
toddlers
was
assessed
via
the
inhalation
route,
and
via
incidental
oral
exposure.
All
of
these
exposures
are
considered
short
term.
Although
cypermethrin
can
be
used
indoors
as
termiticide,
long
term
exposure
due
to
inhalation
is
considered
negligible,
since
the
vapor
pressure
for
cypermethrin
is
extremely
low.
Inhalation
risks
to
both
adults
and
toddlers
were
below
the
Agency's
level
of
concern.
Individually,
risks
from
hand
to
mouth
exposure,
object
to
mouth
exposure,
and
incidental
soil
ingestion
were
all
below
EPA's
level
of
concern.

Aggregate
risk
An
acute
aggregate
risk
assessment
was
conducted
taking
into
account
risk
from
food
and
drinking
water.
EPA
calculated
the
Drinking
Water
Levels
of
Comparison
(
DWLOC,
which
represents
the
maximum
allowable
exposure
from
drinking
water
that
would
still
fall
below
EPA's
level
of
concern)
for
all
population
subgroups.
The
acute
DWLOC
for
the
most
highly
exposed
population
subgroup
(
children
1­
2
years
old)
is
940
ppb,
which
is
much
higher
than
the
peak
EDWC
of
1.04
ppb
in
surface
water
and
the
maximum
EDWC
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
EPA's
level
of
concern.

Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
average
exposure
levels
to
food
and
water
(
considered
to
be
a
background
exposure
level).
The
calculated
DWLOC
value
for
children
1­
2
years
old
is
890
ppb
and
this
level
is
higher
than
the
surface
and
ground
water
EDWCs
of
0.013
and
0.0036
ppb.
Page
9
of
79
Chronic
aggregate
assessment
only
includes
food
and
water
since
chronic
exposure
from
residential
uses
is
negligible.
The
highest
exposed
population
subgroup
(
children
1­
2
years
old)
has
a
DWLOC
value
of
600
ppb,
which
is
greater
than
the
average
annual
EDWCs
of
0.013
ppb
for
surface
water
and
0.0036
ppb
for
ground
water.
Therefore,
chronic
aggregate
risk
does
not
exceed
the
Agency's
level
of
concern.

Cumulative
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,
available
data
shows
that
there
are
multiple
types
of
sodium
channels
and
that
these
compounds
may
act
on
different
isoforms
of
the
sodium
channel
and
with
other
ion
channels
in
producing
their
clinical
signs.
It
is
currently
unknown
whether
the
pyrethroids
as
a
class
have
similar
effects
on
all
channels
or
whether
modifications
of
different
types
of
sodium
channels
would
have
a
cumulative
effect.
Nor
do
we
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function
e.
g.,
nerve
excitability,
or
how
these
key
events
interact
to
produce
their
compound
specific
patterns
of
neurotoxicity.
Without
such
understanding,
there
is
no
basis
to
make
a
common
mechanism
of
toxicity
finding.
Therefore,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids
because
the
Agency
has
determined
further
study
is
needed
regarding
the
assumptions
of
dose
additivity
and
common
mechanism(
s)
of
toxicity
to
appropriately
identify
a
group
or
subgroups
for
such
an
assessment.
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.
The
Agency
anticipates
the
majority
of
this
research
to
be
completed
by
2007.

FQPA
Safety
Factor
The
Agency
determined
that
the
FQPA
safety
factor
should
be
1X
since
there
are
no
residual
uncertainties
for
pre
and/
or
post
natal
toxicity,
and
the
dietary
(
food
and
drinking
water)
and
non­
dietary
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.
No
database
uncertainty
factor
is
needed
since
the
toxicity
database
is
complete.

Occupational
Risk
Short­
term,
intermediate­
term,
and
long­
term
risks
to
occupational
handlers
are
below
the
Agency's
level
of
concern
with
baseline
attire
(
long
sleeved
shirt,
long
pants,
shoes
and
socks),
as
long
as
wettable
powder
formulations
are
packaged
in
water
soluble
bags,
and
chemical
resistant
gloves
are
worn
for
hand­
held
application
methods.
Although
risks
could
not
be
calculated
for
the
one
granular
product
of
cypermethrin,
risks
would
be
lower
than
for
liquid
products
which
is
below
EPA's
level
of
concern
with
baseline
attire.

EPA
did
not
assess
occupational
postapplication
risks
since
no
short­
or
intermediate­
term
dermal
endpoints
were
identified
and
long­
term
dermal
exposures
are
not
expected
for
any
of
the
registered
use
patterns.
As
per
the
Worker
Protection
Standard,
a
restricted­
entry
interval
of
12
hours
is
required
for
agricultural
uses.
Page
10
of
79
Ecological
Risk
The
Agency's
Tier
I
screening­
level
(
deterministic)
risk
assessment
is
focused
on
maximum
uses
of
cypermethrin
on
registered
agricultural
crops
only,
due
to
the
difficulties
of
modeling
and
quantifying
urban
uses.
As
with
several
other
pyrethroids,
the
great
majority
of
cypermethrin
use
is
non­
agricultural.
The
non­
agricultural
applications
of
cypermethrin
may
result
in
exposure
to
aquatic
organisms
following
runoff
and/
or
erosion.
The
Agency
recognizes
the
potential
for
aquatic
toxicity
from
non­
agricultural
uses
but
was
not
able
to
quantify
the
risks
due
to
lack
of
available
data
and
acceptable
models.

Aquatic
Risk
(
fish,
invertebrates)
For
freshwater
fish,
invertebrates,
and
estuarine/
marine
fish,
invertebrates,
technical
grade
cypermethrin
is
very
highly
toxic
on
an
acute
basis.
Cypermethrin
formulations
are
also
very
highly
toxic,
with
LC50
values
that
are
similar
to
those
reported
for
technical
grade
cypermethrin.
LOCs
for
acute
risk
(
0.5)
and
acute
endangered
species
risk
(
0.05)
are
exceeded
for
freshwater
and
estuarine/
marine
invertebrates
for
all
six
crop
scenarios
considered
in
this
assessment.
The
highest
acute
RQs
are
observed
for
freshwater
invertebrates,
ranging
from
49.4
to
558.3,
exceeding
all
acute
LOCs.

LOCs
for
chronic
risk
(
1)
are
exceeded
for
freshwater
and
estuarine/
marine
invertebrates.
The
highest
chronic
RQs
are
observed
for
freshwater
invertebrates,
ranging
from
57.6
to
325.4.
All
chronic
RQs
for
freshwater
fish
and
estuarine/
marine
fish
are
less
than
the
chronic
LOC
(
1).

Terrestrial
Risk
(
birds,
mammals)
For
birds,
all
acute
(
dose­
based
and
dietary­
based)
RQs
are
below
the
acute
risk
LOC
(
0.5)
and
the
endangered
species
LOC
(
0.1)
for
all
crop
uses;
chronic
RQs
are
also
below
the
LOC
(
1).
The
Agency's
screening
level
ecological
risk
assessment
for
endangered
species
results
in
the
determination
that
cypermethrin
will
have
no
direct
acute
or
chronic
effect
on
threatened
and
endangered
birds.

For
mammals,
acute
(
dose­
based)
RQs
are
below
the
acute
risk
LOC
(
0.5).
The
acute
endangered
species
LOC
(
0.1)
is
exceeded
for
15g
and
35g
mammals
feeding
on
short
grass
(
dose­
based
RQs
0.1­
0.2)
for
all
crop
scenarios.
Mammalian
chronic
RQs
(
dose­
based)
range
from
<
0.1
to
9.3
(
15g
mammals
feeding
on
short
grass
in
cotton),
exceeding
the
chronic
LOC
(
1)
for
most
scenarios.

Plants
Toxicity
data
are
not
available
for
terrestrial
plants;
thus,
risks
associated
with
cypermethrin
exposure
to
terrestrial
plants
cannot
be
assessed.
However,
based
on
the
cypermethrin
mode
of
action,
phytotoxicity
is
not
expected.

Non­
target
Insects
Cypermethrin
exposure
can
present
acute
toxic
risk
to
earthworms
and
to
beneficial
non­
target
insects,
such
as
honey
bees.
This
risk
concern
is
extended
to
listed
insects
also.
Page
11
of
79
Benefits
and
Alternatives
Usage
data
are
sparse
and
generally
do
not
distinguish
between
chemicals
within
the
class.
The
recent
loss
of
chlorpyrifos
and
diazinon
for
residential
pest
control
has
resulted
in
a
greater
reliance
on
pyrethrins
and
synthetic
pyrethroids,
as
a
class,
among
residential
users.
Most
pyrethroids
have
similar
efficacy
and
cost.
In
the
absence
of
any
one
pyrethroid,
homeowners
and
professional
applicators
would
most
likely
simply
substitute
another
pyrethroid
insecticide.
Users
might
also
substitute
insecticides
from
other
chemical
classes
(
e.
g.
organophosphates,
carbamates,
and
neonicotinoids)
and
nonchemical
control
techniques
(
e.
g.
sanitation
or
exclusion).
Given
the
options
for
substitution,
economic
impacts
of
restricting
any
one
chemical
would
not
likely
be
significant.
The
impact
on
risk
of
restricting
any
one
chemical
is
uncertain
and
might
increase
given
the
substitutes
available.

Risk
Management
Human
health
risk
To
address
the
handler
risks
of
concern,
the
following
mitigation
is
required:
(
1)
All
wettable
powder
products
must
be
packaged
in
water
soluble
bags
including
agricultural
and
residential
(
PCO/
homeowner)
products.
Alternatively,
replacing
wettable
powder
products
with
products
formulated
as
dry
flowables
would
also
reduce
risks
below
the
Agency's
level
of
concern.

(
2)
Mixers/
loaders/
applicators
using
handheld
equipment
(
all
formulations)
must
wear
chemical
resistant
gloves,
in
addition
to
baseline
attire
(
long
sleeved
shirt,
long
pants,
shoes
and
socks).

Ecological
Risk
To
address
the
ecological
risks
of
concern,
the
following
mitigation
is
required:

For
agricultural
uses:

(
1)
Mitigation
to
address
spray
drift,
including
specifying
minimum
allowable
droplet
size
and
buffer
zones,
maximum
allowable
wind
speed
and
release
height
on
product
labels.
(
2)
Decreased
application
rates
and
increased
application
intervals.
(
3)
A
constructed
and
maintained
vegetative
buffer.

For
non­
agricultural
uses
(
residential,
commercial
and
industrial),
mitigation
includes
limiting
outdoor
applications
to
impervious
surfaces
(
such
as
sidewalks
and
driveways)
to
spot
or
crack
and
crevice
treatments,
and
adding
best
management
practices
to
product
labels
to
reduce
potential
runoff
to
drains,
sewers,
or
water
bodies
from
outdoor
nuisance
pest
and
termite
applications.
Page
12
of
79
Reregistration
Eligibility
The
Agency
has
determined
that
cypermethrin
is
eligible
for
reregistration
provided
that
the
risk
mitigation
measures
outlined
in
this
document
are
adopted
and
labels
are
amended
accordingly.
In
addition,
where
there
are
data
gaps,
data
must
be
generated
to
confirm
the
reregistration
eligibility
decision
documented
in
this
RED.
EPA
will
continue
to
work
with
cypermethrin
and
other
pyrethroid
registrants
to
better
characterize
aquatic
risk
from
urban
uses
of
the
pyrethroids.
More
data
are
needed
to
characterize
ecological
risk,
especially
risk
from
urban
uses.
EPA
will
continue
in
registration
review
to
ensure
the
periodic
review
of
all
pesticides
to
make
sure
they
continue
to
meet
current
scientific
and
regulatory
requirements,
with
the
goal
of
reviewing
each
pesticide
every
fifteen
years.
The
pyethroids
are
tentatively
scheduled
for
re­
evaluation
under
the
proposed
Registration
Review
program
in
2010.
Page
13
of
79
I.
Introduction
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient,
as
well
as
EPA
review
of
all
submitted
data.
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
risks
arising
from
the
currently
registered
uses
of
the
pesticide,
to
determine
the
need
for
additional
data
on
health
and
environmental
effects,
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.

On
August
3,
1996,
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
to
require
reassessment
of
all
tolerances
in
effect
on
the
day
before
it
was
enacted.
In
reassessing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
among
infants
and
children,
and
the
cumulative
effects
of
pesticides
that
have
a
common
mechanism
of
toxicity.
When
the
Agency
determines
that
aggregate
risks
are
not
of
concern
and
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure,
the
tolerances
are
considered
reassessed.
EPA
decided
that,
for
those
chemicals
that
have
tolerances
and
are
undergoing
reregistration,
tolerance
reassessment
will
be
accomplished
through
the
reregistration
process.

The
Food
Quality
Protection
Act
(
FQPA)
requires
that
the
Agency
consider
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
toxic
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
substances
individually.
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,
available
data
shows
that
there
are
multiple
types
of
sodium
channels
and
that
these
compounds
may
act
on
different
isoforms
of
the
sodium
channel
and
with
other
ion
channels
in
producing
their
clinical
signs.
It
is
currently
unknown
whether
the
pyrethroids
as
a
class
have
similar
effects
on
all
channels
or
whether
modifications
of
different
types
of
sodium
channels
would
have
a
cumulative
effect.
Nor
do
we
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function
e.
g.,
nerve
excitability,
or
how
these
key
events
interact
to
produce
their
compound
specific
patterns
of
neurotoxicity.
Without
such
understanding,
there
is
no
basis
to
make
a
common
mechanism
of
toxicity
finding.
Therefore,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids
because
the
Agency
has
determined
further
study
is
needed
regarding
the
assumptions
of
dose
additivity
and
common
mechanism(
s)
of
toxicity
to
appropriately
identify
a
group
or
subgroups
for
such
an
assessment.
There
is
ongoing
research
by
the
EPA's
Office
of
Research
and
Development
and
pyrethroid
registrants
to
evaluate
the
differential
biochemical
Page
14
of
79
and
physiological
actions
of
pyrethroids
in
mammals.
The
Agency
anticipates
the
majority
of
this
research
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/.

The
Agency
made
its
reregistration
eligibility
determination
based
on
the
required
data,
the
current
guidelines
for
conducting
acceptable
studies
to
generate
such
data,
and
published
scientific
literature.
The
Agency
has
found
that
currently
registered
uses
of
cypermethrin
are
eligible
for
reregistration
provided
the
mitigation
and
labeling
outlined
in
the
RED
are
implemented.
The
document
consists
of
six
sections:
Section
I,
the
introduction,
contains
the
regulatory
framework
for
reregistration/
tolerance
reassessment;
Section
II
provides
an
overview
of
the
chemical,
including
a
profile
of
its
use
and
usage;
Section
III
gives
an
overview
of
the
human
health
and
environmental
effects
risk
assessments;
Section
IV
presents
the
Agency's
reregistration
eligibility,
tolerance
reassessment,
and
risk
management
decisions;
Section
V
summarizes
label
changes
necessary
to
implement
the
risk
mitigation
measures
outlined
in
Section
IV;
and
Section
VI
includes
the
appendices,
related
supporting
documents
and
Data
Call­
In
(
DCI)
information.
The
revised
risk
assessment
documents
and
related
addenda
are
not
included
in
this
document,
but
are
available
on
the
Agency's
web
page
http://
www.
epa.
gov/
pesticides,
and
in
the
Public
Docket
at
www.
regulations.
gov
under
docket
number
EPA­
HQ­
OPP­
2005­
0293.

II.
Chemical
Overview
A.
Regulatory
History
Cypermethrin
was
first
conditionally
registered
in
1984
by
FMC
Corporation,
who
also
subsequently
registered
an
isomer
enriched
zeta­
cypermethrin
in
1992.
Current
technical
registrants
include
FMC,
Syngenta,
United
Phosphorus
International,
and
Valent
BioSciences.
Data
for
the
two
active
ingredients
is
considered
interchangeable.
Since
zeta­
cypermethrin
was
registered
after
1984,
only
cypermethrin
is
subject
to
reregistration.
Cypermethrin
is
on
reregistration
List
B;
thus
no
Registration
Standard
was
completed.
Data
Call­
ins
(
DCIs)
for
cypermethrin
were
issued
in
1991
for
basic
toxicology
and
residue
chemistry
data,
and
in
1995
for
handler
exposure
and
worker
re­
entry
data.

Cypermethrin
is
a
synthetic
pyrethroid
insecticide.
On
June
14,
1984,
the
Agency
conditionally
registered
a
technical
grade
product
and
two
end­
use
formulations
each
to
ICI
(
now
known
as
Syngenta
Crop
Protection)
and
FMC
for
use
on
cotton
during
the
1984
growing
season.
The
original
conditional
registration
for
cypermethrin
was
subsequently
renewed
on
January
9,
1985,
and
September
27,
1985.
A
conditional
registration
for
cypermethrin
use
on
pecans
was
issued
on
April
24,
1986.
The
conditional
registration
for
use
on
lettuce
(
head)
was
issued
on
March
15,
1988.

Cypermethrin
is
one
of
nine
synthetic
pyrethroids
registered
on
cotton,
represented
by
the
Pyrethroid
Working
Group
(
PWG),
that
are
considered
to
be
conditionally
registered
pending
the
development
and
review
of
data
related
to
aquatic
toxicity.
EPA
will
make
every
effort
to
Page
15
of
79
coordinate
the
implementation
of
its
reregistration
eligibility
decision
provisions
and
labeling
for
cypermethrin
with
the
ongoing
efforts
of
the
PWG.

Due
to
the
conditional
status
of
the
registration,
tolerances
were
established
for
cypermethrin
on
a
temporary
basis
on
cottonseed,
pecans,
lettuce,
meat,
fat,
and
meat
byproducts
of
hogs,
horses,
cattle,
goats,
sheep,
and
milk
to
cover
residues
expected
to
be
present
from
use
during
the
period
of
conditional
registration.
On
July
31,
1996,
tolerances
were
established
for
brassica
(
head
and
stem)
and
brassica
(
leafy).
The
conditional
registrations
for
all
cypermethrin
uses
were
extended
several
times
to
November
15,
1993,
November
15,
1994,
November
15,
1995,
November
15,
1996
and
November
15,
1997.
At
the
time
of
FQPA,
cypermethrin's
tolerances
had
expiration
dates
of
11/
15/
97.
Agency
policy
was
such
that
no
temporary
or
time­
limited
tolerances
were
to
be
included
among
the
official
baseline
number
of
tolerances
which
the
Agency
had
to
reassess.
These
tolerances
were
considered
revoked
with
an
expiration
date
and
were
expected
not
to
need
tolerance
reassessment,
nor
need
to
be
included
in
the
tolerance
reassessment
baseline
count.

On
November
26,
1997,
permanent
tolerances
were
established
for
brassica
(
head
and
stem),
brassica
(
leafy),
cattle
(
fat),
cattle
(
mbyp),
cattle
(
meat),
cottonseed,
goats
(
fat),
goats
(
mbyp),
goats
(
meat),
hogs
(
fat),
hogs
(
mbyp),
hogs
(
meat),
horses
(
fat),
horses
(
mbyp),
horses
(
meat),
lettuce
(
head),
milk,
onions
(
bulb),
pecans,
sheep
(
fat),
sheep
(
mbyp),
and
sheep
(
meat).
Such
reassessments
were
not
countable
against
the
Agency's
baseline
number
since
they
had
not
been
included
within
the
Agency's
original
tolerance
reassessment
baseline.
Upon
cypermethrin
RED
signature,
no
tolerance
reassessments
will
be
counted
against
the
Agency's
baseline
number,
nor
were
any
previously
counted.

B.
Chemical
Identification
Cypermethrin
has
the
following
structure:

O
O
CN
O
CH
3
C
H
3
Cl
Cl
Physical/
Chemical
Properties
Empirical
Formula:
C22H19Cl2
NO3
Molecular
Weight:
416.3
CAS
Registry
No.:
52315­
07­
8
PC
Code:
109702
Melting
Point:
60­
80
degree
C
Boiling
Point:
216
degree
C
Density:
1.204
g/
mL
at
25
E
C
Vapor
Pressure:
3.1E­
9
mm
Hg
at
20
degree
C
Water
Solubility:
7.6
ppb
at
25
degree
C
Log
P
(
octanol­
water):
6.60
Page
16
of
79
Cypermethrin
is
a
combination
of
8
stereoisomers
with
percentage
compositions
ranging
from
11­
14%,
and
very
low
volatility
and
water
solubility.
Zeta­
cypermethrin
is
an
enriched
enantiomer
of
cypermethrin
consisting
of
the
4
stereo
isomers
with
an
"
S"
configuration
at
the
cyano
bearing
carbon
at
24%
each,
and
4
insecticidally
less
active
stereo
isomers
at
a
concentration
of
1%
each.
Since
the
analytical
method
does
not
distinguish
cypermethrin
from
zeta­
cypermethrin,
and
the
toxicological
endpoints
are
the
same,
the
Agency's
human
health
risk
assessment
and
environmental
fate
assessment
considered
both
cypermethrin
and
zetacypermethrin

C.
Use
Profiles
Type
of
Pesticide:
Insecticide
Summary
of
Use:
Cypermethrin
is
registered
for
agricultural
use
as
a
foliar
application
on
food
and
feed
crops
including
cotton,
pecans,
peanuts,
broccoli
and
other
Brassicas,
and
sweet
corn.
Cypermethrin
can
be
applied
to
livestock
in
eartags,
and
to
horses.
Cypermethrin
is
also
registered
for
use
on
industrial,
commercial,
and
residential
sites.
It
is
registered
for
outdoor
use
as
a
soil
residual
termiticide
and
to
control
insect
pests
such
as
ants
in
and
on
structures,
impervious
surfaces
(
in
perimeter
and
crack
and
crevice
treatments)
and
lawns.
Cypermethrin
can
also
be
applied
indoors
to
control
ants,
cockroaches,
fleas,
and
other
insects.

Target
Organisms:
Cypermethrin
is
registered
for
control
of
a
wide
range
of
pests.

Mode
of
Action:
It
is
likely
that
the
toxic
action
of
pyrethroids
is
primarily
due
to
their
blocking
action
on
some
aspect
of
the
synaptic
function
of
the
nerve
axon.

Tolerances:
There
are
23
cypermethrin
tolerances
established
under
40
CFR
§
180.418(
a)(
1)
for
pecans,
bulb
onions,
cottonseed,
head
and
stem
brassica,
green
onions,
head
lettuce,
leafy
brassica
and
for
the
milk,
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep.

Use
Classification:
Agricultural
products
are
restricted
use.
Residential,
commercial,
and
industrial
products
are
general
use
(
can
be
purchased
and
applied
by
professional
applicators
or
by
residential
applicators).

Formulation
Types:
Cypermethrin
is
formulated
as
an
emulsifiable
concentrate
(
EC),
a
soluble
concentrate/
liquid
(
SC/
L),
and
a
wettable
powder
(
WP).
Cypermethrin
is
compatible
with
a
number
of
insecticides
and
fungicides,
and
has
been
formulated
in
products
with
two
or
more
active
ingredients.
Page
17
of
79
Application
Methods:
Applications
to
agricultural
crops
can
be
made
with
aircraft,
chemigation,
groundboom,
and
air
blast
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.

Application
Rates:
The
currently
labeled
maximum
application
rates
for
agricultural
uses
range
from
0.4
lbs.
a.
i./
acre
to
3.4
lbs.
a.
i./
acre.
The
minimum
retreatment
intervals
range
from
3­
7
days
and
the
preharvest
intervals
(
PHIs)
range
from
1
to
14
days.
The
maximum
application
rate
for
non­
agricultural
uses
is
0.44
lbs
ai/
acre,
for
applications
to
lawns
and
turf.

Application
Timing:
Cypermethrin
agricultural
products
can
be
applied
at
various
stages
of
crop
development.

Usage
of
Cypermethrin:
Total
cypermethrin
use
is
approximately
1.0
million
pounds
of
active
ingredient
(
a.
i.)
per
year.
In
agriculture,
it
is
used
mainly
on
cotton
(
110,000
pounds
a.
i.)
on
about
13%
of
planted
acres.
Minor
use
is
also
found
in
several
other
crops
including
pecans
(
6,000
pounds
a.
i.),
peanuts,
broccoli
and
sweet
corn
(
1
to
2
thousand
pounds
a.
i
each).
Treatment
of
cattle
and
other
livestock
accounts
for
approximately
1,000
pounds
a.
i.
per
year.

The
great
majority
of
cypermethrin
use
occurs
in
non­
agricultural
sites.
Indoor
pest
control
(
mainly
for
ants,
cockroaches,
and
fleas)
accounts
for
about
110,000
pounds
a.
i.,
while
outdoor
use
for
subterranean
termites
and
other
insect
pests
accounts
for
nearly
750,000
pounds
a.
i.
Of
the
non­
agricultural
use,
approximately
300,000
pounds
a.
i.
are
applied
by
residential
applicators,
and
550,000
pounds
a.
i.
by
professional
applicators.

III.
Summary
of
Cypermethrin
Risk
Assessments
The
purpose
of
this
section
is
to
highlight
the
key
features
and
findings
of
the
risk
assessments
in
order
to
help
the
reader
better
understand
the
risk
management
decisions
reached
by
the
Agency.
While
the
risk
assessments
and
related
addenda
are
not
included
in
this
document,
they
are
available
in
the
OPP
Public
Docket
http://
www.
regulations.
gov.
Page
18
of
79
A.
Human
Health
Risk
Assessment
The
following
is
a
summary
of
EPA's
human
health
findings
and
conclusions
for
cypermethrin
as
presented
fully
in
the
document,
"
Cypermethrin:
Phase
4
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED).
PC
Code
109702;
DP
Barcode
D293416.
Dated
06­
APR­
2006.

1.
Toxicity
Technical
grade
cypermethrin
has
moderate
acute
toxicity
via
the
dermal
and
inhalation
routes
(
Category
III
&
IV),
and
is
not
a
skin
sensitizer.
It
is
more
toxic
via
the
oral
route
(
Category
II).

Table
1:
Acute
Toxicity
Profile
Guideline
No.
Study
Type
MRID
Results
Toxicity
Category
870.1000
Acute
Oral
­
rat
00056800
LD50
(
M):
247
mg/
kg
(
F):
309
mg/
kg
females
II
870.1100
Acute
Dermal
Rat
Rabbit
00056800
00056800
LD50
>
4920
mg/
kg/
day.

Abraded
skin:
LD50
>
2460
mg/
kg.
III
870.1200
Acute
Inhalation
­
rat
42395702
LC50:
%
(
not
calculated
but
higher
than
&)
LC50:
&
2.5
(
1.6­
3.4)
mg/
L.
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
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.

Developmental
and
Reproductive
Toxicity
Cypermethrin
is
not
a
developmental
or
reproductive
toxicant.
In
prenatal
developmental
toxicity
studies
in
rats
and
rabbits,
there
was
no
evidence
of
developmental
toxicity
at
the
highest
Page
19
of
79
dose
tested.
In
multi­
generation
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
increase
in
the
severity
of
toxicity
for
the
pups.

Neurotoxicity
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.
For
cypermethrin,
neuromuscular
effects
(
i.
e.
gait
abnormalities,
tremors,
reduced
motor
activity,
changes
in
FOB
parameters
and
convulsions)
occurred
across
species,
sexes
and
routes
of
administration.
These
clinical
signs
occurred
following
an
acute
exposure
and
appeared
to
be
transient
in
nature.
Effects
occurred
mainly
in
oral
studies
in
the
dog
and
the
rat,
but
similar
signs
were
also
observed
in
an
inhalation
study.
Effects
were
not
observed
in
dermal
studies
in
either
rats
(
zeta­
cypermethrin)
or
rabbits
(
cypermethrin:
nonabraded
animals;
abraded
animals
did
exhibit
decreases
in
activity).

Toxicological
Endpoints
Table
2
contains
endpoints
selected
for
the
dietary
and
residential
assessments.

Table
2:
Summary
of
Toxicological
Doses
and
Endpoints
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
general
population
including
infants
and
children
NOAEL
=
10
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.1
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.1
mg/
kg/
day
MRID
44962201:
Acute
neurotoxicity
study
in
the
rat
with
zetacypermethrin
LOAEL
=
50
mg/
kg/
day
based
on
clinical
signs
of
neurotoxicity
and
changes
in
the
FOB.

Chronic
Dietary
all
populations
NOAEL=
6
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.06
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
0.06
mg/
kg/
day
MRID
44536801:
Chronic
feeding
study
in
the
dog.
LOAEL
=
20.4
mg/
kg/
day
based
on
clinical
signs
of
neurotoxicity
and
mortality
in
males,
and
18.1
mg/
kg/
day
based
on
decreased
body
weights
and
body
weight
gains
in
females.

Short­
Term
Incidental
Oral
(
1
to
30
days)
NOAEL=
10
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
N/
A
MRID
44962201:
Acute
neurotoxicity
study
in
the
rat
with
zetacypermethrin
LOAEL
=
50
mg/
kg/
day
based
on
clinical
signs
of
neurotoxicity
and
changes
in
the
FOB
Page
20
of
79
Table
2:
Summary
of
Toxicological
Doses
and
Endpoints
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Intermediate­
Term
Incidental
Oral
(
1
­
6
months)
NOAEL=
5.0
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
N/
A
MRID
44962202:
Subchronic
neurotoxicity
study
in
the
rat
with
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
MRID
45010401:
No
systemic
effects
in
21­
day
dermal
study
with
zetacypermethrin
up
to
1000
mg/
kg/
day
and
no
developmental
concern.
No
hazard
identified
to
support
quantification
of
risk.

Long­
Term
Dermal
(>
6
months)
Oral
NOAEL=
0.6
mg/
kg/
day
(
dermal
absorption
factor
=
2.5%)
Occupational
LOC
for
MOE
=
100
MRID
44536801:
Chronic
feeding
study
in
the
dog.
LOAEL
=
20.4
mg/
kg/
day
based
on
clinical
signs
of
neurotoxicity
and
mortality
in
males,
and
18.1
mg/
kg/
day
based
on
decreased
body
weights
and
body
weight
gains
in
females.

Short­
and
Intermediate­
Term
Inhalation
(
1
day
to
6
months)
Inhalation
NOAEL=
0.01
mg
a.
i./
L/
day
(
2.7
mg/
kg/
day)
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
100
MRID
43507101:
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.

Long­
Term
Inhalation
(>
6
months)
Inhalation
NOAEL=
0.01
mg
a.
i./
L
(
2.7
mg/
kg/
day)
Occupational
LOC
for
MOE
=
300
for
the
lack
of
long­
term
study.
Route­
to­
route
estimation
would
result
in
less
protective
endpoint.
MRID
43507101:
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
quantification
required.

UF
=
uncertainty
factor,
FQPA
SF
=
FQPA
safety
factor,
NOAEL
=
no
observed
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.

2.
FQPA
Safety
Factor
During
the
Agency's
phase
3
reregistration
process,
an
FQPA
safety
factor
of
10x
was
retained
due
to
database
uncertainty
(
the
lack
of
DNT
study).
The
DNT
study
has
now
been
submitted,
Page
21
of
79
reviewed,
and
found
to
be
acceptable.
The
Agency
has
determined
that
the
FQPA
safety
factor
should
be
reduced
to
1X,
since
there
are
no
residual
uncertainties
for
pre­
and/
or
post­
natal
toxicity.
In
addition,
EPA
has
concluded
that
there
is
no
need
to
change
any
previously­
selected
endpoints
based
on
the
submitted
DNT,
and
that
and
the
dietary
(
food
and
drinking
water)
and
non­
dietary
exposure
assessments
are
protective
of
potential
exposures
to
infants
and
children.

3.
Dermal
Absorption
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
zeta­
cypermethrin).
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.

4.
Dietary
Exposure
a.
Acute
Dietary
Exposure
(
food
only)

Zeta­
cypermethrin
is
an
S­
enantiomer
enriched
formulation
of
cypermethrin.
Since
the
analytical
method
does
not
distinguish
cypermethrin
from
zeta­
cypermethrin,
and
the
toxicological
endpoints
are
the
same,
the
dietary
and
non­
dietary
(
residential)
aggregate
risk
assessment
included
potential
exposures
from
both
chemicals.
The
residue
of
concern
for
tolerance
enforcement
and
risk
assessment
is
the
parent
compound
(
cypermethrin)
only.
EPA
performed
a
refined
(
probabilistic)
acute
dietary
assessment
using
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
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.

Dietary
risk
assessment
incorporates
both
exposure
to
and
toxicity
of
a
given
pesticide.
Dietary
risk
is
expressed
as
a
percentage
of
a
level
of
concern.
The
level
of
concern
is
the
dose
predicted
to
result
in
no
unreasonable
adverse
health
effects
to
any
human
population
subgroup,
including
sensitive
members
of
such
population
subgroups.
This
level
of
concern
is
referred
to
as
the
population
adjusted
dose
(
PAD),
which
reflects
the
reference
dose
(
RfD),
either
acute
or
chronic,
adjusted
to
account
for
the
FQPA
safety
factor.

Estimated
risks
that
are
less
than
100%
of
the
PAD
are
below
EPA's
level
of
concern.
The
acute
PAD
(
aPAD)
is
the
highest
predicted
dose
to
which
a
person
could
be
exposed
on
any
given
day
with
no
adverse
health
effects
expected.
For
cypermethrin,
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.
Page
22
of
79
b.
Chronic
Dietary
Exposure
(
food
only)

A
refined
chronic
dietary
assessment
was
performed
using
PDP
data,
percent
crop
treated
information,
and
processing
factors
where
appropriate.
The
assessment
was
conducted
using
DEEM­
FCID
 
,
Version
1.3.
The
chronic
PAD
(
cPAD)
is
the
highest
predicted
dose
to
which
a
person
could
be
exposed
over
the
course
of
a
lifetime
with
no
adverse
health
effects
expected.
Chronic
risk
estimates
for
cypermethrin
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.

5.
Drinking
Water
Exposure
(
For
a
complete
discussion,
see
the
"
Tier
II
Estimated
Environmental
Concentrations
of
Cypermethrin
for
the
Use
in
the
Human
Health
Risk
Assessment"
dated
05/
02/
2005,
and
the
"
Water
Exposure/
Risk,
section
4.3
of
the
HED
Chapter.)

Based
on
the
available
data,
cypermethrin/
zeta­
cypermethrin
is
a
moderately
persistent
chemical
that
primarily
degrades
by
photolysis
in
water
and
biodegradation.
Cypermethrin
is
hydrologically
stable
at
neutral
pH.
Cypermethrin
is
more
light
stable
than
the
first
or
second
generation
pyrethroids
like
allethrin
and
resmethrin,
but
still
undergoes
photolysis
in
water,
with
half­
lives
of
about
a
month
or
more
in
distilled
water.
The
rate
of
photolysis
appears
to
be
enhanced
in
natural
waters
(
which
contain
photosensitizing
agents
like
humic
and
fulvic
acids),
where
it
degrades
with
half­
lives
of
a
few
days.
It
binds
tightly
to
soil
particles
and
is
not
likely
to
move
to
groundwater.
The
Agency
has
determined
that
the
residue
of
toxicological
concern
to
be
included
in
drinking
water
assessment
is
the
parent
compound
only.

The
Estimated
Drinking
Water
Concentrations
(
EDWCs)
for
cypermethrin
were
estimated
using
PRZM/
EXAMS,
based
on
modeling
six
aerial
applications
to
cotton
in
North
Carolina
at
the
maximum
application
rate
of
0.1
lbs
a.
i./
A
(
for
a
yearly
maximum
of
0.6
lb
a.
i./
A).
According
to
the
label,
the
maximum
application
rate
is
0.6
lb
a.
i./
A
per
season,
so
for
certain
crops
like
lettuce
which
have
several
growing
seasons
in
one
year,
exposures
could
be
higher.
The
exposure
scenarios
modeled
assumed
only
one
season
per
year.
The
estimated
acute
drinking
water
concentration
in
surface
water
is
1.04
ppb,
and
the
estimated
chronic
drinking
water
concentration
in
surface
water
is
0.013
ppb
(
this
value
represents
the
mean
over
a
30­
year
period).
Various
other
scenarios
were
also
assessed
(
CA,
MS
and
TX
cotton,
CA
onion,
and
CA
lettuce),
but
they
consistently
yielded
lower
EDWCs.
The
SCI­
GROW
model
generated
an
EDWC
for
groundwater
based
on
a
maximum
application
rate
for
cypermethrin
of
six
applications
of
0.1
lbs
a.
i./
A
(
this
rate
is
representative
of
both
cotton
and
lettuce).
The
groundwater
EDWC
for
both
acute
and
chronic
exposures
is
0.0036
ppb.

6.
Residential
Exposure
and
Risk
(
For
a
complete
discussion
see,
"
Cypermethrin
and
Zeta­
Cypermethrin:
Revised
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document",
dated
April
5,
2006,
DP
barcode
D293417).
Page
23
of
79
The
general
public
can
be
exposed
to
cypermethrin
when
applying
the
pesticide
for
indoor
and
outdoor
residential
pest
control,
or
subsequent
to
applications
made
by
residential
applicators
or
professional
applicators.
Non­
cancer
risk
estimates
are
expressed
as
a
margin
of
exposure
(
MOE)
which
is
a
ratio
of
the
dose
from
a
toxicological
study
selected
for
risk
assessment,
typically
a
NOAEL,
to
the
predicted
exposure.
Estimated
MOEs
are
compared
to
a
level
of
concern
which
reflects
the
dose
selected
for
risk
assessment
and
uncertainty
factors
(
UFs)
applied
to
that
dose.
The
standard
UF
is
100x
which
includes
10x
for
interspecies
extrapolation
(
to
account
for
differences
between
laboratory
animals
and
humans)
and
10x
for
intraspecies
variation
(
to
account
for
differences
between
humans).
Additional
uncertainty
or
safety
factors
may
also
be
applied.
In
the
case
of
cypermethrin,
EPA's
level
of
concern
is
an
MOE
of
100.

a.
Residential
Handler
Risk
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
risks
were
assessed.

EPA
did
assess
short­
term
inhalation
exposures
and
risks
to
residential
handlers,
for
the
following
scenarios:

 
Mixing/
Loading/
Applying
Liquid
concentrates
with
Low
Pressure
Handwand
 
Mixing/
Loading/
Applying
Liquid
concentrates
with
Wipes
 
Applying
Ready
to
Use
Formulations
with
a
Pump
Sprayer
(
PHED
aerosol
can
data)
 
Applying
Ready
to
Use
Formulations
with
Aerosol
Cans
 
Applying
Ready
to
Use
Formulations
with
Fogger
 
Applying
Ready
to
Use
Formulations
with
Wipes
Residential
inhalation
risks
are
below
EPA's
level
of
concern
(
i.
e.,
MOE
>
100)
for
all
nonoccupational
handler
scenarios.
All
MOEs
were
greater
than
16,000
which
is
below
the
Agency's
level
of
concern.

A
granular
product
was
registered
on
February
23,
2006
(
EPA
registration
#
28293­
367).
This
product
is
for
application
to
fire
ant
mounds
on
lawns
and
outside
of
homes.
Similar
products
are
registered
for
liquid
zeta­
cypermethrin
and
for
liquid
and
wettable
powder
cypermethrin
formulations.
Due
to
lack
of
formulation­
specific
exposure
data,
no
quantitative
risk
assessment
could
be
conducted
for
the
cypermethrin
granular
formulation.
However,
the
Agency
believes
that
the
risk
to
residential
handlers
from
exposure
to
this
product
will
not
exceed
that
for
liquid
products,
which
is
below
the
EPA's
level
of
concern.

b.
Residential
Post­
application
Risk
Since
no
effects
were
observed
in
any
dermal
exposure
study,
non­
dietary
post­
application
exposure
to
adults
was
assessed
via
the
inhalation
route
only.
Exposure
to
toddlers
was
assessed
via
the
inhalation
route,
and
via
incidental
oral
exposure.
All
of
these
exposures
are
considered
short
term.
Although
cypermethrin
can
be
used
indoor
as
termiticide
use,
long
term
exposure
Page
24
of
79
due
to
inhalation
is
considered
negligible,
since
the
vapor
pressure
for
cypermethrin
is
extremely
low.
In
general,
post­
application
inhalation
risks
following
outdoor
applications
are
considered
negligible
as
well.

Post­
application
inhalation
risks
following
indoor
fogger
applications
were
assessed
using
timeweighted
averages
from
a
cyfluthrin
room
fogger
air
monitoring
study.
Post­
application
inhalation
risks
following
indoor
aerosol
spray
applications
to
carpets
were
assessed
using
air
concentration
estimates
from
the
crack
and
crevice
subset
of
PHED,
and
using
a
House
Model
to
estimate
an
emission
rate.

Inhalation
risks
to
both
adults
and
toddlers
were
below
the
Agency's
level
of
concern
(
i.
e.,
MOE
>
100).
All
indoor
inhalation
MOEs
for
toddlers
and
adults
were
greater
than
71,000
which
is
below
the
Agency's
level
of
concern.

Post­
application
risks
to
toddlers
from
incidental
oral
ingestion
were
assessed
using
a
short­
term
incidental
oral
endpoint
(
10
mg/
kg/
day).
Incidental
oral
exposure
to
toddlers
was
assessed
for
the
following
scenarios:

 
Hand
to
mouth
activity
on
turf
 
Object
to
mouth
activity
on
turf
 
Incidental
soil
ingestion
 
Hand
to
mouth
activity
from
indoor
surfaces
following
crack
&
crevice
treatments
 
Hand
to
mouth
activity
from
indoor
surfaces
following
broadcast
fogger
treatments
The
results
indicate
that
risks
from
short­
term
incidental
oral
exposures
were
below
EPA's
level
of
concern
for
all
indoor
and
outdoor
scenarios,
all
MOEs
were
greater
than
900.

7.
Aggregate
Exposure
and
Risk
(
food,
drinking
water,
and
residential)

In
accordance
with
FQPA,
the
Agency
must
consider
pesticide
exposures
and
risks
from
all
potential
sources.
These
usually
include
food,
drinking
water,
and
residential
exposures.
In
an
aggregate
assessment,
exposures
from
relevant
sources
are
added
together
and
compared
to
quantitative
estimates
of
hazard
(
e.
g.,
a
NOAEL
or
PAD),
or
the
risks
themselves
can
be
aggregated.
When
aggregating
exposures
and
risks
from
various
sources,
the
Agency
considers
both
the
route
and
duration
of
exposure.
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.

a.
Acute
Aggregate
Risk
(
food
and
drinking
water)

In
order
to
calculate
aggregate
risk
from
exposure
to
cypermethrin
residues
in
food
and
drinking
water,
EPA
compared
estimated
cypermethrin
concentrations
in
surface
and
groundwater
(
the
EDWCs
presented
in
section
III.
A.
4.)
with
Drinking
Water
Levels
of
Comparison
(
DWLOCs).
A
Page
25
of
79
DWLOC
is
the
portion
of
the
PAD
remaining
after
estimated
dietary
(
food
only)
exposures
have
been
subtracted,
and
the
remaining
exposure
has
been
converted
to
a
concentration
in
ppb.
This
concentration
value,
or
DWLOC,
represents
the
potential
drinking
water
exposure
that
would
still
fall
below
EPA's
level
of
concern.
As
long
as
the
maximum
EDWCs
for
surface
and
ground
water
are
less
than
the
DWLOC,
aggregate
risks
from
food
and
drinking
water
exposures
are
below
EPA's
level
of
concern.

In
the
case
of
cypermethrin,
the
lowest
acute
DWLOC
of
940
ppb
for
children
1­
2
years
old
is
much
higher
than
the
peak
EDWC
of
1.04
ppb
in
surface
water
and
0.0036
ppb
for
ground
water;
therefore,
acute
aggregate
risk
estimates
associated
with
exposure
to
cypermethrin
residues
in
food
and
water
do
not
exceed
the
Agency's
level
of
concern.

b.
Short­
term
Aggregate
Risk
(
food,
drinking
water,
and
residential)

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
residential
uses
constitute
short­
term
exposure
scenarios;
endpoints
have
been
selected
for
shortterm
incidental
oral
and
inhalation
exposures,
and
the
acceptable
MOE
for
all
short­
term
exposures
is
100.
Since
the
toxicological
effects
through
the
inhalation
exposure
route
are
similar
to
the
toxicological
effects
from
oral
exposures,
the
short­
term
aggregate
risk
assessment
was
conducted
by
adding
the
residential
inhalation
exposure,
oral
non­
dietary
exposure,
and
average
food
and
water
exposure.
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.

Short­
term
aggregate
risk
does
not
exceed
Agency's
level
of
concern
for
any
population
subgroup.
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
EDWCs
of
0.013
and
0.0036
ppb,
respectively.

c.
Chronic
Aggregate
Risk
(
food
and
drinking
water)

Although
cypermethrin
can
be
used
indoors
as
a
termiticide,
long
term
inhalation
exposure
is
not
expected
due
to
its
very
low
vapour
pressure
(
3.1E­
9
mm
Hg
at
20
0C).
Therefore,
the
chronic
aggregate
assessment
only
includes
food
and
water.
Chronic
dietary
estimates
of
exposure
from
food
were
taken
from
the
dietary
exposure
model
results
described
above.
The
calculated
DWLOCs
for
children
1­
2
years
old
has
the
lowest
chronic
DWLOC
value
of
600
ppb,
which
is
greater
than
both
the
surface
water
(
0.013
ppb)
and
ground
water
(
0.0036
ppb)
EDWCs;
therefore,
chronic
aggregate
risk
estimates
do
not
exceed
the
Agency's
level
of
concern.

8.
Occupational
Exposure
and
Risk
For
a
complete
discussion,
see
section
7.0
of
the
"
Cypermethrin:
Phase
4
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED).
PC
Code
109702;
DP
Barcode
D293416",
dated
April
6,
2006.
Also,
see
"
Cypermethrin
and
Zeta­
Cypermethrin:
Revised
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document",
Page
26
of
79
dated
April
5,
2006,
DP
barcode
D293417.
Although
the
occupational
risk
assessment
included
zeta­
cypermethrin,
only
cypermethrin
occupational
assessment
results
are
discussed
here,
since
this
reregistration
decision
applies
only
to
cypermethrin
products.

Workers
can
be
exposed
to
cypermethrin
through
mixing,
loading,
and
applying
the
pesticide
for
use
on
agricultural
crops
and
livestock,
and
for
use
in
indoor
and
outdoor
industrial,
commercial,
and
residential
settings.

a.
Occupational
Handler
Risk
Short­
and
intermediate­
term
dermal
risks
were
not
assessed
for
occupational
handlers,
since
no
short­
or
intermediate­
term
dermal
endpoints
were
identified.
Short
and
intermediate­
term
inhalation
risks
to
handlers
when
mixing,
loading,
and
applying
cypermethrin
products
were
assessed
for
the
following
agricultural
and
non­
agricultural
scenarios:

 
Mixing
and
loading
liquid
and
wettable
powder
formulations
to
support
aerial,
chemigation,
groundboom,
and
airblast
applications
to
agricultural
crops
 
Applying
sprays
with
aerial,
groundboom,
or
airblast
equipment
to
agricultural
crops
 
Flagging
to
support
aerial
applications
 
Mixing,
loading,
and
applying
liquid
formulations
using
a
low
pressure
handwand
sprayer,
a
paint
brush,
a
low
pressure/
high
volume
turf/
handgun
sprayer,
or
a
termiticide
injector
 
Mixing,
loading,
and
applying
wettable
powder
formulations
using
a
low
pressure
handwand
sprayer,
a
paint
brush,
or
a
low
pressure/
high
volume
turf/
handgun
sprayer
 
Mixing,
loading,
and
applying
wettable
powder
formulations
packaged
in
water
soluble
bags
using
a
low
pressure/
high
volume
turf/
handgun
sprayer
 
Applying
Ready­
to­
Use
eartags,
trigger
pump
sprayers,
wipes,
aerosol
cans,
or
foggers
When
data
were
available
to
assess
risks,
short­
and
intermediate­
term
inhalation
risks
to
occupational
handlers
are
below
the
Agency's
level
of
concern
(
i.
e.,
MOE
>
100)
at
baseline
(
long
sleeved
shirt,
long
pants,
shoes
and
socks)
for
all
formulations
except
the
wettable
powder.
For
handlers
mixing
and
loading
to
support
aerial
applications
to
cotton
(
a
high
acreage
crop),
sodfarms,
and
agricultural
uncultivated
areas,
fencerows
and
hedgerows,
MOEs
at
baseline
range
from
4
to
37.
The
addition
of
engineering
controls
(
packaging
wettable
powders
in
water
soluble
bags)
reduces
the
risks
to
below
EPA's
level
of
concern
for
all
scenarios.
EPA
has
insufficient
data
to
assess
exposures
to
pilots
in
open
cockpits.
Inhalation
risks
to
pilots
in
enclosed
cockpits
were
below
EPA's
level
of
concern
for
all
agricultural
crop
scenarios.
No
data
are
available
to
assess
inhalation
risks
during
the
application
of
impregnated
eartags;
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).

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
Page
27
of
79
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
longterm
occupational
workers
are
100
for
dermal
risk
and
300
inhalation
risk.
Since
these
MOEs
differ,
an
aggregate
risk
index
(
ARI)
was
used
to
assess
combined
long­
term
dermal
and
inhalation
risks
to
handlers.
The
target
ARI
is
1;
therefore,
ARIs
of
less
than
1
indicate
potential
risks
of
concern.

Long­
term
combined
dermal
and
inhalation
risks
were
assessed
for
the
following
scenarios:

 
Mixing,
loading,
and
applying
liquid
and
wettable
powder
formulations
using
a
low
pressure
handwand
sprayer,
a
paint
brush,
or
a
low
pressure/
high
volume
turf/
handgun
sprayer
 
Mixing,
loading,
and
applying
wettable
powder
formulations
packaged
in
water
soluble
bags
using
a
low
pressure/
high
volume
turf/
handgun
sprayer
Combined
long­
term
dermal
and
inhalation
risks
are
below
EPA's
level
of
concern
for
all
scenarios
involving
liquid
formulations
at
baseline
attire
or
with
the
addition
of
chemicalresistant
gloves
to
baseline
attire.
Combined
long­
term
dermal
and
inhalation
risks
are
below
EPA'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.
Although
data
were
not
available
to
estimate
the
risks
from
mixing/
loading
and
applying
wettable
powders
packaged
in
water
soluble
bags
with
a
low­
pressure
handwand
sprayer,
the
risks
are
expected
to
be
lower
than
for
liquid
products
(
below
EPA's
level
of
concern
with
the
addition
of
chemicalresistant
gloves
to
baseline
attire).
A
similar
reduction
in
risk
would
be
expected
if
wettable
powder
products
were
reformulated
into
dry
flowable
formulations.

b.
Occupational
Post­
application
Risk
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.

EPA
did
not
assess
occupational
postapplication
exposures
and
risks
following
applications
of
cypermethrin
and
zeta­
cypermethrin
to
residential
and
commercial
lawns,
and
in
and
around
industrial,
commercial,
and
residential
premises,
since
no
short­
or
intermediate­
term
dermal
endpoints
of
concern
were
identified
and
long­
term
exposures
are
not
expected
for
tasks
involving
any
of
the
registered
use
patterns.

9.
Human
Incident
Data
(
For
a
complete
discussion,
see
"
Review
of
Cypermethrin
Incident
Reports.
DP
Barcode
D293143,
Chemical
#
109702",
dated
08/
26/
2003.)
Page
28
of
79
Pyrethroids,
like
cypermethrin,
have
relatively
low
toxicity
to
humans.
Skin
and
eye
irritation,
nausea,
vomiting,
coughing
and
difficulty
breathing
were
the
most
commonly
reported
symptoms.
As
with
other
pyrethroids,
burning
or
tingling
sensations
are
often
reported
by
applicators
(
World
Health
Organization
1989).
The
occurrence
of
moderate
and
more
serious
symptoms
was
generally
more
prevalent
among
those
exposed
to
cypermethrin
than
those
exposed
to
other
pesticides.
Reports
suggest
that
cypermethrin
can
cause
asthma
or
asthma­
like
symptoms
in
susceptible
individuals.
See
Section
IV
for
further
discussion
of
incidents
and
mitigation.

B.
Environmental
Risk
Assessment
More
detailed
information
can
be
found
in
the
"
Revised
EFED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
on
Cypermethrin
After
30­
Day
"
Error
Only"
Comment
Period",
DP
Barcode:
D293412,
dated
October
25,
2005
and
the
"
Addendum
to
the
EFED
RED
Chapter
for
Cypermethrin",
DP
Barcode
D293413,
dated
June
9,
2006.

The
majority
of
cypermethrin
use
occurs
in
non­
agricultural
sites.
Non­
agricultural
applications
of
cypermethrin,
such
as
perimeter
treatments
around
buildings
and
applications
to
lawns,
may
result
in
exposure
to
aquatic
organisms
from
surface
runoff
and/
or
erosion.
Even
though
cypermethrin
has
a
strong
affinity
to
bind
to
soils
and
surfaces,
residues
at
concentrations
toxic
to
aquatic
organisms
have
been
measured
in
streams
that
receive
runoff
from
suburban
developments.
A
study
recently
conducted
in
an
urban
area
of
California
found
residues
of
cypermethrin
and
other
pyrethroids
in
urban
streams
adjacent
to
residential
areas
and
suggested
that
these
areas
are
unlikely
to
be
unique,
particularly
in
dry
regions
where
landscape
irrigation
can
dominate
seasonal
flow
in
some
water
bodies.
The
Agency
recognizes
the
potential
for
aquatic
toxicity
from
non­
agricultural
uses.
However,
EPA
was
not
able
to
assess
the
risks
associated
with
urban
runoff
due
to
limited
monitoring
data
and
lack
of
acceptable
models.
The
Agency's
future
plans
to
assess
non­
agricultural
uses
of
cypermethrin
and
other
pyrethroids
are
discussed
in
Section
IV.

The
Agency's
Tier
I
screening­
level
(
deterministic)
risk
assessment
is
focused
on
registered
agricultural
uses
only.
A
summary
of
the
Agency's
environmental
fate
assessment
is
presented
below.

1.
Environmental
Fate
and
Transport
For
the
most
part,
the
environmental
fate
data
for
cypermethrin
were
from
studies
on
cypermethrin;
however,
some
studies
were
conducted
on
zeta­
cypermethrin
as
well
as
other
isomers.
Both
cypermethrin
and
zeta­
cypermethrin
are
expected
to
have
similar
fate
in
the
environment.

Cypermethrin
is
expected
to
bind
strongly
to
organic
carbon
and
have
little
mobility
in
soil
(
KOC
values
ranged
from
20,800
to
385,000
L/
kg),
and
therefore
it
is
not
likely
to
leach
into
groundwater.
Due
to
its
relatively
low
mobility,
cypermethrin
is
most
likely
to
reach
adjacent
bodies
of
water
via
spray
drift,
through
runoff
events
accompanied
by
soil
erosion,
or
in
runoff
from
outdoor
impervious
surfaces.
Cypermethrin
is
moderately
persistent
in
the
environment
Page
29
of
79
and
degrades
through
a
combination
of
biotic
and
abiotic
mechanisms.
In
soil,
under
both
aerobic
and
anaerobic
conditions,
cypermethrin
biodegrades
relatively
slowly,
with
half­
lives
on
the
order
of
about
2
months.
In
contrast,
degradation
is
enhanced
in
water,
with
aerobic
and
anaerobic
metabolism
half­
lives
of
9
to
17
days.
If
released
to
surface
water,
cypermethrin
partitions
to
sediment,
where
it
may
degrade
more
slowly.
In
terrestrial
field
dissipation
studies,
cypermethrin
did
not
appear
to
persist
in
soil,
where
the
major
routes
of
degradation
are
photolysis
and
aerobic
biodegradation.
Degradation
of
cypermethrin
through
photolysis
appears
to
be
enhanced
in
natural
waters
which
contain
humic
and
fulvic
acids.
However,
field
studies
conducted
on
rice
(
with
zeta­
cypermethrin)
show
high
persistence
in
aquatic
sediments.
If
cypermethrin
is
applied
repeatedly,
it
is
possible
that
the
chemical
can
accumulate
in
the
sediment
in
ever
larger
amounts,
with
slow
biodegradation.
Cypermethrin
bioaccumulates
moderately
(
488x)
in
fish.

2.
Ecological
Risk
The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
toxicity
studies
to
estimated
environmental
concentrations
(
EECs)
based
on
environmental
fate
characteristics
and
pesticide
use
data.
To
evaluate
the
potential
risk
to
non­
target
organisms
from
the
use
of
cypermethrin
products,
the
Agency
calculates
a
Risk
Quotient
(
RQ),
which
is
the
ratio
of
the
EEC
to
the
most
sensitive
toxicity
endpoint
values,
such
as
the
median
lethal
dose
(
LD50)
or
the
median
lethal
concentration
(
LC50).
These
RQ
values
are
then
compared
to
the
Agency's
levels
of
concern
(
LOCs),
which
indicate
whether
a
pesticide,
when
used
as
directed,
has
the
potential
to
cause
adverse
effects
to
non­
target
organisms.
When
the
RQ
exceeds
the
LOC
for
a
particular
category,
the
Agency
presumes
a
risk
of
concern.
These
risks
of
concern
may
be
addressed
by
further
refinements
of
the
risk
assessment
or
mitigation
measures.
Use,
toxicity,
fate,
and
exposure
are
considered
when
characterizing
the
risk,
as
well
as
the
levels
of
uncertainty
in
the
assessment.
EPA
further
characterizes
ecological
risk
based
on
any
reported
incidents
to
non­
target
terrestrial
or
aquatic
organisms
in
the
field
(
e.
g.,
fish
or
bird
kills).

Table
3.
EPA's
Levels
of
Concern
and
Associated
Risk
Presumptions
Risk
Presumption
LOC
Terrestrial
Animals
LOC
Aquatic
Animals
LOC
Plants
Acute
Risk
­
there
is
potential
for
acute
risk
0.5
0.5
1
Acute
Endangered
Species
­
endangered
species
may
be
adversely
affected
0.1
0.05
1
Chronic
Risk
­
there
is
potential
for
chronic
risk
1
1
N/
A
a.
Risk
to
Aquatic
Organisms
i.
Fish
and
Invertebrate
Toxicity
The
results
of
acute
toxicity
studies
in
fish,
invertebrates,
and
benthic
organisms
show
that
technical
grade
cypermethrin
is
very
highly
toxic
on
an
acute
basis.
For
freshwater
fish
and
Page
30
of
79
estuarine/
marine
fish,
the
lowest
toxicity
values
reported
were
an
LC50
of
0.39
µ
g
a.
i./
L
(
rainbow
trout),
and
an
LC50
of
0.95
µ
g
a.
i./
L
(
sheepshead
minnow),
indicating
that
these
organisms
all
have
a
similar
susceptibility
to
cypermethrin.
For
freshwater
invertebrates
the
lowest
toxicity
values
reported
were
an
LC50
of
0.0036
µ
g
a.
i./
L
(
waterflea)
and
for
estuarine/
marine
invertebrates
an
LC50
of
0.00475
µ
g
ai/
L
(
mysid
shrimp),
approximately
100
times
lower
than
the
toxicity
values
reported
for
fish.
These
results
indicate
that
freshwater
and
estuarine/
marine
invertebrates
are
substantially
more
sensitive
than
other
types
of
aquatic
organisms
to
cypermethrin
toxicity,
and
that
they
are
expected
to
be
at
greatest
risk
for
acute
effects
(
death).

The
available
experimental
LC50
value
for
benthic
amphipods
is
expressed
in
terms
of
sediment
concentration
of
cypermethrin
(
LC50
=
3.6
µ
g
a.
i./
kg
sediment).
To
assess
risk
to
benthic
organisms
in
terms
of
pore
water,
a
surrogate
benthic
organism
LC50
value
for
pore
water
(
0.00257
µ
g
a.
i./
L
pore
water)
was
derived
using
the
sediment
LC50
value
and
the
average
Koc
value
(
141,700)
for
cypermethrin.
In
oysters,
cypermethrin
is
categorized
as
highly
toxic
(
370
µ
g
a.
i./
L).

Cypermethrin
formulations
are
also
very
highly
toxic,
with
LC50
values
that
are
similar
to
those
reported
for
technical
grade
cypermethrin.

Table
4.
Cypermethrin
(
Technical
Grade)
Acute
Toxicity
Reference
Values
for
Aquatic
Organisms.

Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
(
µ
g
a.
i./
L)
Effects
Reference
Freshwater
Fish
rainbow
trout
96
hours
LC50
=
0.39
µ
g
a.
i./
L
Morbidity
MRID
44546027
Freshwater
Invertebrates
amiphod
48
hours
LC50
=
0.0036
µ
g
a.
i./
L
Morbidity
MRID
44423501
Benthic
Organisms
amphipod
10
days
sediment
value
(
experimental
data):
LC50
=
3.6
µ
g
a.
i./
kg
sediment
pore
water
value
(
derived
data):
LC50
=
0.00257
µ
g
a.
i./
L
pore
water
Morbidity
and
Growth
MRID
44074406
Page
31
of
79
Table
4.
Cypermethrin
(
Technical
Grade)
Acute
Toxicity
Reference
Values
for
Aquatic
Organisms.

Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
(
µ
g
a.
i./
L)
Effects
Reference
Estuarine/
Marine
Fish
sheepshead
minnow
96
hours
LC50
=
0.95
µ
g
a.
i./
L
Morbidity
MRID
90075
Estuarine/
Marine
Invertebrates
mysid
shrimp
96
hours
LC50
=
0.00475
µ
g
a.
i./
L
Morbidity
Acc.
No.
42444601
Chronic
toxicity
studies
are
available
for
freshwater
fish
and
estuarine/
marine
invertebrates.
Results
in
freshwater
fish
show
that
neonate
survival
is
adversely
affected
by
cypermethrin
exposure
(
NOAEC
=
0.14
µ
g
a.
i./
L).
For
estuarine/
marine
invertebrates,
chronic
exposure
to
cypermethrin
produced
adverse
effects
on
reproductive
(
NOAEC
=
0.0015
µ
g
a.
i./
L)
and
growth
parameters
(
NOAEC
=
0.000781
µ
g
a.
i./
L).

Table
5.
Cypermethrin
(
Technical
Grade)
Chronic
Toxicity
Reference
Values
for
Aquatic
Organisms.

Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
(
µ
g
a.
i./
L)
Effects
Reference
Freshwater
Fish
fathead
minnow
30
days
NOAEC
=
0.14
µ
g
a.
i./
L
LOAEC
=
0.33
µ
g
ai/
L
Growth
and
morbidity
MRID
89039
Freshwater
Invertebrates
No
adequate
data
submitted;
to
assess
chronic
risk
to
freshwater
invertebrates,
surrogate
NOAEC
value
of
0.00059
µ
g
a.
i./
L
was
derived
based
on
the
acute:
chronic
ratio
method
using
acute
and
chronic
data
for
estuarine/
marine
invertebrates.
Benthic
Organisms
No
chronic
data
submitted;
to
assess
chronic
risk
to
benthic
organisms,
surrogate
chronic
NOAEC
toxicity
values
for
sediment
of
0.59
µ
g
a.
i./
kg
sediment
and
for
pore
water
of
0.00042
µ
g
a.
i./
L
pore
water
were
derived
based
on
the
acute:
chronic
ratio
method
using
acute
and
chronic
data
for
estuarine/
marine
invertebrates.
Estuarine/
Mar
ine
Fish
No
data
submitted;
to
assess
chronic
risk
to
estuarine/
marine
fish,
a
surrogate
NOAEC
value
of
0.34
µ
g
a.
i./
L
for
sheepshead
minnow
was
derived
based
on
the
acute:
chronic
ratio
method
using
acute
and
chronic
data
for
freshwater
fish.
e
Page
32
of
79
Table
5.
Cypermethrin
(
Technical
Grade)
Chronic
Toxicity
Reference
Values
for
Aquatic
Organisms.

Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
(
µ
g
a.
i./
L)
Effects
Reference
Estuarine/
Marine
Invertebrates
mysid
shrimp
28
days
NOAEC
=
0.000781
µ
g
a.
i./
L
LOAEC
=
0.00197
µ
g
ai/
L
NOAEC
=
0.0015
µ
g
ai/
L
LOAEC
=
0.0028
µ
g
ai/
L
Weight
of
females
reduced
Number
of
offspring
reduced
MRID
42725301
ii.
Fish
and
Invertebrate
Exposure
For
exposure
to
aquatic
fish
and
invertebrates,
EPA
considers
surface
water
only,
since
most
aquatic
organisms
are
not
found
in
ground
water.
Estimated
environmental
concentrations
(
EECs)
for
cypermethrin
calculated
using
the
Tier
II
PRZM/
EXAMS
models
and
employing
maximum
application
rates,
indicate
that
cypermethrin
preferentially
partitions
to
the
sediment.
Three
crop
usage
scenarios,
which
constitute
approximately
90%
of
cypermethrin's
total
crop
usage,
were
considered:
cotton,
lettuce,
and
pecans.
Modeling
produced
the
highest
EECs
for
cotton
crops
in
North
Carolina
and
Mississippi.
A
complete
listing
of
EECs
can
be
found
in
the
EFED
risk
assessment,
dated
October
25,
2005.

iii.
Fish
and
Invertebrate
Risk
To
assess
risks
of
cypermethrin
to
non­
target
aquatic
animals
(
i.
e.,
fish
and
invertebrates),
EPA
uses
the
peak
concentration
to
derive
RQs
for
acute
exposure
and
the
21­
day
average
concentration
to
derive
RQs
for
chronic
exposure.
RQs
are
calculated
as
the
concentration
(
peak
or
average
EEC)
divided
by
the
relevant
endpoint
(
LC50
for
acute
risk,
NOAEC
for
chronic
risk).
Since
results
of
acute
toxicity
studies
in
freshwater
fish
and
invertebrates
indicate
that
the
major
cypermethrin
degradate
(
3­
phenoxy
benzoic
acid)
is
much
less
toxic
than
the
parent
compound,
EECs
and
RQs
were
derived
only
for
the
parent
compound,
not
for
total
residue
(
parent
plus
degradates).
Acute
risk
quotient
(
RQ)
values
were
calculated
using
the
endpoint
from
the
most
sensitive
species
tested
within
a
taxonomic
group.

Acute
RQs
for
aquatic
organisms
are
summarized
in
Table
6.
The
LOC
for
acute
risk
(
LOC
0.5)
is
exceeded
for
all
aquatic
organisms
and
modeled
crop
scenarios,
except
CA
cotton
for
freshwater
invertebrates
and
estuarine/
marine
fish,
and
CA
lettuce
for
estuarine/
marine
fish.
LOCs
for
acute
endangered
species
risk
(
LOC
0.05)
are
exceeded
for
freshwater
fish
and
Page
33
of
79
invertebrates
and
estuarine/
marine
fish
and
invertebrates
for
all
six
crop
scenarios
assessed.
The
highest
acute
RQs
are
observed
for
freshwater
invertebrates,
ranging
from
49.4
(
CA
cotton)
to
558.3
(
NC
cotton),
exceeding
all
acute
LOCs.

Table
6.
Acute
RQs
for
Freshwater
Fish,
Freshwater
Invertebrates,
Estuarine/
Marine
Fish
and
Estuarine/
Marine
Invertebrates
Exposed
to
Cypermethrin.

Crop
Use
PRZM/
EXAMS
Scenario
Freshwater
Fish
Acute
RQ
Freshwater
Invertebrate
Acute
RQ
Estuarine/
Marine
Fish
Acute
RQ
Estuarine/
Marine
Invertebrate
Acute
RQ
California
0.5
49.4
0.2
37
Mississippi
3.3
355.6
1.3
269
North
Carolina
5.2
558.3
2.1
423
Cotton
Texas
1.3
136.9
0.5
104
Pecans
Georgia
2.4
264.7
1.0
201
Lettuce
(
Head)
California
0.7
80.6
0.3
61
Chronic
RQs
for
aquatic
animals
are
summarized
in
Table
7.
For
freshwater
invertebrates,
chronic
RQs
range
from
57.6
to
325.4
and
for
estuarine/
marine
invertebrates,
chronic
RQs
range
from
44
to
246
and,
exceeding
the
chronic
LOC
(
1).
For
freshwater
fish
and
estuarine/
marine
fish,
all
chronic
RQs
are
below
the
chronic
LOC.

Table
7.
Chronic
RQs
for
Freshwater
Fish,
Freshwater
Invertebrates,
Estuarine/
Marine
Fish
and
Estuarine/
Marine
Invertebrates
Exposed
to
Cypermethrin.
Crop
Use
PRZM/
EXAMS
Scenario
Freshwater
Fish
Chronic
RQ
Freshwater
Invertebrate
Chronic
RQ
Estuarine/
Marine
Fish
Chronic
RQ
Estuarine/
Marine
Invertebrate
Chronic
RQ
California
0.2
93.2
0.1
70
Mississippi
0.7
318.6
0.3
241
North
Carolina
0.7
325.4
0.3
246
Cotton
Texas
0.2
101.7
0.1
77
Pecans
Georgia
0.3
145.8
0.1
110
Lettuce
(
Head)
California
0.1
57.6
0.1
44
Sediment
Exposure
­
Acute
and
Chronic
Risk
Acute
and
chronic
RQs
have
been
derived
for
exposure
of
benthic
organisms
to
sediments
and
pore
water
(
Table
10).
All
acute
and
chronic
RQs
for
benthic
organisms
exceed
the
LOCs
for
acute
risk
(
LOC
0.5),
acute
endangered
species
risk
(
LOC
0.05)
and
chronic
risk
(
LOC
1)
for
all
modeled
crop
uses.
There
are
several
uncertainties
regarding
both
acute
and
chronic
RQs.
Due
to
data
gaps,
acute
RQs
for
pore
water
and
chronic
RQs
for
sediment
and
pore
water
were
derived
from
estimated
toxicity
values
based
on
the
acute
sediment
toxicity
value.
However,
there
is
considerable
uncertainty
surrounding
the
acute
sediment
toxicity
value,
since
this
value
was
obtained
from
a
study
using
a
water­
sediment
system
that
was
not
at
equilibrium
(
sediment
concentrations
decreased
throughout
the
exposure
period).
Page
34
of
79
Table
8.
Acute
and
Chronic
RQs
for
Benthic
Organisms
Exposed
to
Cypermethrin.

Crop
Use
PRZM/
EXAM
S
Scenario
Sediment
Acute
RQ
Pore
Water
Acute
RQ
Sediment
Chronic
RQ
Pore
Water
Chronic
RQ
California
7
2
35
9
Mississippi
44
11
228
57
North
Carolina
48
12
244
60
Cotton
Texas
13
3
52
13
Pecans
Georgia
26
7
123
31
Lettuce
(
Head)
California
8
2
47
12
iv.
Aquatic
Plant
Toxicity,
Exposure
and
Risk
Toxicity
data
are
not
available
for
aquatic
plants;
thus,
risks
associated
with
cypermethrin
exposure
to
aquatic
plants
could
not
be
assessed.
However,
based
on
cypermethrin's
mode
of
action,
cypermethrin
is
not
expected
to
be
phytotoxic.
In
addition,
the
Agency
is
not
aware
of
any
plant
incidents
involving
exposure
to
cypermethrin.

v.
Effect
of
Buffers
on
Spray
Drift
The
screening­
level
risk
assessment
indicates
that
peak
EECs
exceed
acute
levels­
of­
concern
for
all
aquatic
taxa
considered.
The
ecological
risk
assessment
includes
an
evaluation
of
the
relative
contribution
of
runoff
and
spray
drift
to
the
exposure
simulated
by
PRZM/
EXAMS.
A
hypothetical
scenario
was
run
(
for
use
on
NC
cotton)
in
which
application
of
cypermethrin
resulted
in
no
spray
drift.
The
resulting
EEC
of
2.2
µ
g
a.
i./
L,
which
represented
transport
of
cypermethrin
to
water
via
runoff
and
erosion
alone,
is
high
enough
to
exceed
the
acute
LOC
for
all
aquatic
taxa.

The
effect
of
a
150­
foot
spray
buffer
on
potential
exposure
from
runoff
and
erosion
cannot
currently
be
quantified.
Presumably,
the
mass
of
cypermethrin
that
would
be
applied
to
that
portion
the
field
within
150
feet
of
a
water
body
would
be
less
than
that
applied
to
the
rest
of
the
crop,
and
would
decline
with
distance.
However,
the
PRZM
model
is
an
edge­
of­
field
model
which
cannot
simulate
an
untreated
area
between
the
field
and
the
receiving
water
body.

The
expected
effect
of
a
spray
buffer
on
exposure
through
spray
drift
can
be
quantified
using
the
AgDRIFT
model,
which
was
developed
using
extensive
field
data
collected
by
the
Spray
Drift
Task
Force.
This
is
important
because
while
the
EEC
from
PRZM/
EXAMS
used
in
the
screening
model
represents
a
1­
in­
10­
year
exposure
from
combined
runoff/
erosion
and
spray
drift,
the
output
from
AgDRIFT
can
be
made
to
represent
the
amount
of
exposure
from
spray
drift
that
could
occur
any
time
a
pesticide
is
applied.

AgDRIFT
modeling
for
cypermethrin
indicates
that
the
exposure
from
spray
drift
alone
could
be
sufficient
to
exceed
levels
of
concern
for
aquatic
organisms,
and
that
implementation
of
a
spray
buffer
can
reduce
that
exposure
significantly.
Using
typical
spray
conditions
(
10
ft.
release
height,
10
mph
wind,
and
a
fine­
to­
medium
droplet
size
distribution
[
DSD]),
the
AgDRIFT
model
simulates
a
concentration
of
0.73
µ
g
a.
i./
L
in
the
standard
pond
from
spray
drift
if
no
buffer
zone
is
observed.
Risk
quotients
calculated
with
this
EEC
would
exceed
the
acute
LOCs
of
0.5
for
freshwater
and
estuarine/
marine
fish
and
invertebrates.
Page
35
of
79
The
table
below
shows
the
effect
of
spray
buffers
on
the
concentration
of
cypermethrin
that
AgDRIFT
simulates
in
the
standard
pond.
These
values
reflect
the
typical
spray
conditions
described
above,
and
an
application
rate
of
0.1
lb
ai/
acre:

Table
9.
Effect
of
Various
Buffers
on
EECs
Buffer
(
ft)
0
50
100
150
200
Concentration
(
µ
g
a.
i./
L)
0.73
0.44
0.31
0.24
0.20
When
a
buffer
of
150
feet
is
simulated,
the
resulting
concentration
of
cypermethrin
in
the
pond
resulting
from
drift
alone
is
reduced
by
two­
thirds.
This
is
sufficient
to
reduce
the
EEC
below
the
acute
level­
ofconcern
of
0.5
for
estuarine/
marine
fish
(
RQ
=
0.24
µ
g
a.
i./
L/
0.95
µ
g
a.
i./
L
=
0.25).
This
reduction
would
not
reduce
the
risk
quotients
for
drift
alone
below
the
acute
LOC
for
freshwater
fish
(
RQs
of
0.61),
but
the
reduction
in
exposure
could
lead
to
lower
levels
of
mortality,
and
perhaps
be
sufficiently
protective
for
less
sensitive
species.
The
toxicity
reference
values
for
freshwater
and
estuarine/
marine
invertebrates
(
LC50
=
0.0036
and
0.0048
µ
g
a.
i./
L,
respectively)
are
so
low
that
even
a
two­
third
reduction
in
exposure
still
results
in
RQs
far
above
the
LOC
(
RQ
=
67
and
50,
respectively).

The
use
of
a
spray
buffer
would
reduce
exposure
under
conditions
other
than
the
typical
conditions
described
above,
but
conditions
more
conducive
to
spray
drift
could
result
in
unacceptable
exposure
from
drift
alone
regardless
of
the
buffer.
For
instance,
if
the
wind
speed
(
10
mph)
and
release
height
(
10
ft)
are
kept
the
same
as
above,
but
a
very
fine­
to­
fine
DSD
is
simulated
instead
of
a
fine­
to­
medium
DSD,
much
greater
exposure
to
cypermethrin
could
result.

Table
10.
Effect
of
Various
Buffers
Using
Fine­
to­
Fine
Droplets
on
EECs
Buffer
(
ft)
0
50
100
150
200
Concentration
(
µ
g
a.
i./
L)
1.7
1.2
0.96
0.8
0.68
The
resulting
amount
of
spray
drift
would
lead
to
more
than
three
times
the
exposure
at
150
feet
than
if
the
fine­
to­
medium
DSD
were
used,
and
the
resulting
EECs
would
still
exceed
the
LOC
for
all
aquatic
taxa.

In
summary,
a
150­
foot
no­
spray
buffer
can
result
in
significant
reductions
in
exposure
and
risk
to
aquatic
organisms,
provided
that
application
occurs
under
typical
conditions
and
the
DSD
used
for
application
is
not
too
fine.
Such
exposure
from
spray
drift
alone
can
be
expected
any
time
cypermethrin
is
applied,
regardless
of
whether
a
significant
runoff/
erosion
event
happens
soon
after.

vi.
Risk
to
Aquatic
Organisms
from
Non­
Agricultural
Uses
In
addition
to
these
potential
acute
and
chronic
risks
from
agricultural
uses,
aquatic
organisms
may
be
exposed
to
cypermethrin
from
non­
agricultural
uses,
as
well.
The
Agency
has
received
and
considered
the
results
of
a
published
study
that
measured
pyrethroid
residues
in
stream
sediments
adjacent
to
an
urban
subdivision
in
California.
The
study
found
toxic
residue
levels
of
Page
36
of
79
cypermethrin
and
other
pyrethroids
in
stream
sediments
that
receive
runoff
from
the
subdivisions
via
storm
drains
and
summer
over­
irrigation
of
landscapes
and
lawns
(
Weston,
et
al.,
2005).
Although
bifenthrin
was
the
major
pyrethroid
found,
cypermethrin
concentrations
were
also
of
toxic
significance
to
aquatic
invertebrates.
Weston's
work
is
significant
because
it
documents
the
presence
of
pyrethroids
in
the
sediments
of
creeks
near
residential
areas.
Since
most
of
the
use
of
cypermethrin
is
in
non­
agricultural
settings,
urban
uses
pose
additional
risks
to
aquatic
systems
that
the
Agency
cannot
quantitatively
assess
at
this
time.
EPA
currently
is
evaluating
appropriate
modeling
approaches
to
assess
risks
from
urban
runoff
(
see
Chapter
IV
for
further
discussion).

b.
Risk
to
Terrestrial
Organisms
i.
Bird
and
Mammal
Toxicity
Results
of
acute
toxicity
studies
on
birds
suggest
that
cypermethrin
is
practically
non­
toxic
to
slightly
toxic
to
avian
species
(
LD50
>
2,000
mg
a.
i./
kg
body
weight;
LC50
>
2,634
mg
a.
i./
kg
diet)
on
an
acute
basis.
Chronic
avian
studies
showed
no
adverse
effects
at
50
mg
a.
i./
kg
diet
(
the
highest
dose
tested),
but
the
study
was
incomplete
because
a
LOAEC
was
not
determined
Mammalian
data
suggest
that
cypermethrin
is
moderately
toxic
(
LD50
=
247
mg/
kg
body
weight)
on
an
acute
basis.
A
chronic
study
in
rats
showed
adverse
effects
(
decreased
body
weight
and
body
weight
gain)
in
adults
and
offspring
(
NOAEC
=
5.0
mg
a.
i./
kg/
body
weight/
day;
100
mg
a.
i./
kg
diet).

Table
11.
Cypermethrin
Toxicity
Reference
Values
for
Terrestrial
Organisms.

Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
Reference
Mammals
Acute
(
Dose­
based)
rat
single
oral
dose
LD50
(
M):
247
mg/
kg/
body
wt
MRID
00056800
Chronic
(
Dietary­
based
and
Dose­
based)
rat
3
generation
reproduction
study
NOAEL
(
toxicity
to
parents
and
offspring)
=
5.0
mg/
kg/
day
LOAEC
=
(
toxicity
to
parents
and
offspring)
=
25
mg/
kg/
day
MRID
00090040
Birds
Acute
(
Dose­
based)
bobwhite
quail
single
oral
dose
LD50
>
2,000
mg
a.
i./
kg
body
wt
MRID
44546024
Acute
(
Dietary­
based)
mallard
duck
5­
day
dietary
LC50
>
2,634
mg
a.
i./
kg
diet
MRID
00090071
Page
37
of
79
Table
11.
Cypermethrin
Toxicity
Reference
Values
for
Terrestrial
Organisms.

Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
Reference
Chronic
(
Dietary­
based)
mallard
duck
and
bobwhite
quail
Avian
reproduction
NOAEC
>
50
mg
a.
i./
kg
diet
MRID
42322902
MRID
42322901
ii.
Bird
and
Mammal
Exposure
The
Agency
assessed
exposure
to
terrestrial
organisms
by
first
predicting
the
amount
of
cypermethrin
residues
found
on
animal
food
items
and
then
using
information
on
typical
food
consumption
by
various
species
of
birds
and
mammals
to
determine
the
amount
of
pesticide
consumed.
The
amount
of
residues
on
animal
feed
items
is
based
on
the
Fletcher
nomogram,
which
is
a
model
developed
by
Hoerger
and
Kenaga
(
1972)
and
modified
by
Fletcher
(
1994),
and
the
current
maximum
application
rates
for
cypermethrin.

Estimated
exposure
concentrations
for
terrestrial
receptors
were
determined
using
the
standard
screening­
level
exposure
model,
TREX
(
v.
1.1),
which
is
a
simulation
model
that,
in
addition
to
incorporating
the
nomogram
relationship,
also
includes
pesticide
degradation
in
the
estimation
of
EECs.
TREX
considers
exposure
only
in
the
area
where
cypermethrin
is
applied.
The
underlying
assumption
is
that
most,
if
not
all,
of
the
applied
pesticide
will
settle
in
the
use
area.
However,
depending
on
weather
conditions
and
type
of
application,
spray
drift
of
pesticides
may
occur,
increasing
the
likelihood
of
wildlife
exposure
outside
the
use
area.
Since
cypermethrin
is
applied
via
spray
methods,
spray
drift
is
likely
to
occur
and
in
some
cases
could
be
a
significant
source
of
exposure.

Four
crop
usage
scenarios
were
assessed:
cotton,
pecans,
lettuce,
and
canola.
Cypermethrin
maximum
dose­
based
EECs
ranged
from
1.2­
122
mg/
kg
body
weight
for
birds,
and
0.1­
102
mg/
kg
body
weight
for
mammals.

iii.
Bird
and
Mammal
Risk
For
birds,
all
acute,
dose­
based
and
dietary
based
RQs
are
below
the
LOC
for
acute
risk
(
LOC
0.5)
and
endangered
species
(
LOC
0.1)
for
all
crop
uses.
However,
the
acute
endangered
species
LOC
(
0.1)
is
exceeded
for
15g
and
35g
mammals
feeding
on
short
grass
(
dose­
based
RQs
0.1­
0.2)
for
all
crop
scenarios,
and
for
15g
mammals
feeding
on
broadleaf
plants/
small
insects
in
cotton
(
RQ
=
0.11).

Chronic,
dietary­
based
RQs
for
birds
are
all
below
the
LOC
for
chronic
risk
(
LOC
1).
It
was
not
possible
to
calculate
a
chronic
dose­
based
RQ
for
birds
because
there
were
no
acceptable
dosebased
toxicity
values
for
birds
available.
For
mammals,
chronic,
dose­
based
RQs
range
from
<
0.1
to
9.3
(
15g
mammals
feeding
on
short
grass
in
cotton),
exceeding
the
chronic
LOC
(
1)
for
Page
38
of
79
most
scenarios.
The
chronic
dietary­
based
RQ
(
1.1)
exceeded
the
chronic
LOC
(
1)
for
mammals
feeding
on
short
grass
in
cotton.

iv.
Non­
target
Insect
Toxicity,
Exposure
and
Risk
Results
of
available
toxicity
studies
indicate
that
cypermethrin
is
highly
toxic
to
honey
bees
(
LD50
=
0.023
­
0.56
ug/
bee)
and
very
toxic
to
earthworms
(
LC50
=
26.09
ug/
cm2)
on
an
acute
contact
basis.
Thus,
honey
bees
and
other
non­
target
terrestrial
invertebrates
(
e.
g.
beneficial
insects
and
listed
insects)
are
expected
to
be
at
risk
for
acute
effects
(
lethality).
No
RQ
values
for
non­
target
insects
were
derived;
however,
risks
can
be
assessed
qualitatively.
Cypermethrin
toxicity
data
show
that
it
is
very
highly
toxic
to
honey
bees
and
is
considered
to
be
highly
toxic
on
both
a
contact
and
an
oral
basis.
Cypermethrin
was
also
found
to
be
highly
toxic
to
honey
bees
exposed
to
foliage
that
had
been
sprayed
with
a
cypermethrin
formulation
(
Cymbush
3E).
In
addition,
cypermethrin
has
also
been
shown
to
be
highly
toxic
to
earthworms.
Based
on
these
results,
acute
risks
to
non­
target
insects
and
terrestrial
invertebrates
are
anticipated
for
the
uses
considered
in
this
assessment.

v.
Terrestrial
Plants
As
for
aquatic
plants,
toxicity
data
are
not
available
for
terrestrial
plants
and
risks
could
not
be
assessed.
Cypermethrin
is
not
expected
to
be
phytotoxic
based
on
its
mode
of
action,
and
no
incidents
involving
terrestrial
plants
have
been
reported
to
the
Agency.

c.
Ecological
Incidents
A
total
of
10
aquatic
incidents
involving
cypermethrin
exposure
have
been
reported
to
EPA
and
tracked
by
Ecological
Incident
Information
System
(
EIIS).
All
incidents
were
categorized
according
to
the
Certainty
Index
as
follows:
possible
(
3
reports);
probable
(
3
reports);
and
highly
probable
(
4
reports).
Although
in
about
half
of
these
aquatic
incidents
the
source
of
cypermethrin
was
not
reported,
several
fish
kills
were
attributed
to
termiticide
use
of
cypermethrin.

A
total
of
five
incidents
involving
terrestrial
organisms
(
birds,
goats,
dog)
were
noted.
The
incident
involving
birds
(
5000
sparrows)
was
attributed
to
birds
eating
insects
that
had
been
killed
from
cypermethrin
use
the
previous
night
on
an
eggplant
crop.

d.
Endangered
Species
Concerns
The
Agency's
screening
level
ecological
risk
assessment
for
endangered
species
results
in
the
determination
that
cypermethrin
will
have
no
direct
acute
effects
on
threatened
and
endangered
birds.
However,
potential
indirect
effects
to
any
species
dependent
upon
a
species
that
experiences
effects
cannot
be
precluded
from
use
of
cypermethrin.
These
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
effect"
findings
under
the
Endangered
Species
Act.
Page
39
of
79
For
birds,
all
acute
RQs
are
below
the
endangered
species
LOC
(
0.1)
for
all
crop
uses.
The
Agency's
acute
endangered
species
LOC
for
birds
was
not
exceeded
in
the
screening
level
assessment,
but
one
incident
involving
acute
effects
on
birds
was
reported.

For
mammals,
the
acute
endangered
species
LOC
(
0.1)
is
exceeded
for
15g
and
35g
mammals
feeding
on
short
grass
(
dose­
based
RQs
0.1­
0.2)
for
all
crop
scenarios
and
aquatic
organisms
(
LOC
=
0.05)
were
exceeded.
The
maximum
calculated
acute
RQs
for
all
organisms
resulted
from
modeling
cypermethrin
use
on
North
Carolina
cotton;
the
maximum
screening
level
acute
RQs
which
exceed
acute
LOCs
are
shown
in
Table
12,
below.

Table
12.
Maximum
acute
RQs
in
screening
level
assessment.
Organism
Maximum
Acute
RQ
Mammals
0.2
Freshwater
fish
5.2
Freshwater
invertebrates
558.3
Estuarine/
marine
fish
2.1
Estuarine/
marine
invertbrates
423
Benthic
organisms
(
sediment
exposure)
48
Benthic
organisms
(
pore
water
exposure)
12
The
Agency's
screening
level
assessment
results
in
the
determination
that
cypermethrin
will
have
no
direct
chronic
effects
on
birds
(
all
RQs
are
less
than
the
chronic
LOC
of
1.0).
However,
the
chronic
LOC
is
exceeded
for
mammals,
freshwater
and
estuarine/
marine
invertebrates,
and
benthic
organisms.
The
maximum
calculated
chronic
RQs
for
all
organisms
resulted
from
modeling
cypermethrin
use
on
North
Carolina
cotton;
the
maximum
screening
level
chronic
RQs
which
exceed
the
chronic
LOC
are
shown
in
Table
13,
below.

Table
13.
Maximum
chronic
RQs
in
screening
level
assessment.
Organism
Maximum
Chronic
RQ
Mammals
(
dose­
based
risk)
9.3
Freshwater
invertebrates
325.4
Estuarine/
marine
invertbrates
246
Benthic
organisms
(
sediment
exposure)
244
Benthic
organisms
(
pore
water
exposure)
60
No
data
were
submitted
to
evaluate
the
risk
of
cypermethrin
exposure
to
non­
target
terrestrial
plants.
However,
the
agency
has
determined
that
cypermethrin
will
have
no
effect
on
listed
plants.
Also,
no
incident
reports
have
reliably
linked
cypermethrin
or
any
other
synthetic
pyrethroid
to
phytoxic
effects
despite
the
fact
that
pyrethroids
are
often
applied
on
or
near
agricultural
crops.

All
of
these
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
effect"
findings
under
the
Endangered
Species
Act.
Rather,
this
assessment
serves
as
a
screen
to
determine
the
need
for
any
species
specific
assessments
that
will
evaluate
whether
exposure
may
be
at
levels
that
could
cause
harm
to
specific
listed
species
and
their
critical
habitat.
That
assessment
refines
the
screening­
level
assessment
to
take
into
account
the
Page
40
of
79
geographic
area
of
pesticide
use
in
relation
to
the
listed
species,
the
habits
and
habitat
requirements
of
the
listed
species,
etc.
If
the
Agency's
species
specific
assessments
result
in
the
need
to
modify
use
of
the
pesticide
in
specific
geogrpahic
areas,
those
changes
to
the
pesticide's
registration
will
take
through
the
process
described
in
the
Agency's
Federal
Register
Notice
(
54
FR
27984)
regarding
implementation
of
the
Endangered
Species
Protection
Program.

IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
A.
Determination
of
Reregistration
Eligibility
and
Tolerance
Reassessment
Section
4(
g)(
2)(
A)
of
FIFRA
calls
for
the
Agency
to
determine,
after
submission
of
relevant
data
concerning
an
active
ingredient,
whether
or
not
products
containing
the
active
ingredient
are
eligible
for
reregistration.
The
Agency
has
previously
identified
and
required
the
submission
of
the
generic
data
to
support
reregistration
of
products
containing
cypermethrin
and
has
determined
that
the
data
are
sufficient
to
support
reregistration.

The
Agency
has
completed
its
assessment
of
the
dietary,
residential,
occupational
and
ecological
risk
associated
with
the
use
of
cypermethrin.
Based
on
this
assessment
the
Agency
has
sufficient
information
to
make
decisions
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
reregistration
process
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
cypermethrin
containing
products
are
eligible
for
reregistration
provided
that
label
amendments
are
made
as
outlined
in
this
RED.
Appendix
A
summarizes
the
uses
of
cypermethrin
that
are
eligible
for
reregistration.
Appendix
B
identifies
the
generic
data
requirements
that
the
Agency
reviewed
as
part
of
its
determination
of
reregistration
eligibility,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.

Based
on
its
evaluation
of
cypermethrin,
the
Agency
has
determined
that
cypermethrin
products,
unless
labeled
and
used
as
specified
in
this
document,
would
present
risks
inconsistent
with
FIFRA
and
FQPA.
Accordingly,
should
a
registrant
fail
to
implement
any
of
the
reregistration
requirements
identified
in
this
document,
the
Agency
may
take
regulatory
action
to
address
the
risk
concerns
from
the
use
of
cypermethrin.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
cypermethrin
will
be
adequately
mitigated
for
the
purposes
of
this
determination.
Once
an
Endangered
Species
assessment
is
completed,
further
changes
to
these
registrations
may
be
necessary
as
explained
under
"
Endangered
Species
Concerns"
above.

B.
Public
Comments
and
Responses
Through
the
Agency's
public
participation
process,
EPA
worked
with
stakeholders
and
the
public
to
reach
the
regulatory
decisions
for
cypermethrin.
EPA
released
its
cypermethrin
preliminary
risk
assessments
for
public
comment
on
December
28,
2005,
for
a
60­
day
public
comment
period
(
Phase
3
of
the
public
participation
process).
During
the
public
comment
period,
the
Agency
received
comments
from
the
technical
registrants,
the
California
water
quality
control
boards,
the
California
Stormwater
Quality
Association,
and
other
stakeholders.
These
comments
in
their
entirety,
responses
to
the
comments,
as
well
as
the
preliminary
and
Page
41
of
79
revised
risk
assessments,
are
available
in
the
public
docket
(
EPA­
HQ­
OPP­
2005­
0293)
at
http://
www.
regulations.
gov.

C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
Even
though
cypermethrin
tolerances
are
not
included
in
EPA's
baseline
tolerance
reassessment
counts,
EPA
assessed
the
risks
associated
with
cypermethrin.
EPA
has
concluded
that
the
tolerances
for
cypermethrin
meet
FQPA
safety
standards.
In
reaching
this
determination,
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
aggregate
exposure
from
food
and
residential
sources.

b.
Determination
of
Safety
to
U.
S.
Population
The
Agency
has
determined
that
the
established
tolerances
for
cypermethrin,
with
amendments
and
changes
as
specified
in
this
document,
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
D)
of
the
FFDCA,
as
amended
by
FQPA,
and
that
there
is
a
reasonable
certainty
no
harm
will
result
to
the
general
population
or
any
subgroup
from
the
use
of
cypermethrin.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices,
and
the
environmental
behavior
of
cypermethrin.
As
discussed
in
Section
III,
aggregate
acute,
short­,
intermediate­,
and
long­
term
risks
from
food,
drinking
water,
and
residential
exposures
are
below
the
Agency's
LOC.

c.
Determination
of
Safety
to
Infants
and
Children
EPA
has
determined
that
the
established
tolerances
for
cypermethrin,
with
amendments
and
changes
as
specified
in
this
document,
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
that
there
is
a
reasonable
certainty
of
no
harm
for
infants
and
children.
The
safety
determination
for
infants
and
children
considers
factors
on
the
toxicity,
use
practices
and
environmental
behavior
noted
above
for
the
general
population,
but
also
takes
into
account
the
possibility
of
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
cypermethrin
residues
in
this
population
subgroup.

In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
exposure
to
residues
of
cypermethrin,
the
Agency
considered
the
completeness
of
the
hazard
database
for
developmental
and
reproductive
effects
including
a
developmental
neurotox
study,
the
nature
of
the
effects
observed,
and
other
information.
The
FQPA
Safety
Factor
has
been
reduced
to
1X,
because
there
are
no
residual
uncertainties
for
pre­
and/
or
post­
natal
toxicity,
exposure
is
not
underestimated,
and
there
is
no
evidence
of
increased
susceptibility.
Page
42
of
79
2.
Endocrine
Disruptor
Effects
The
available
database
provides
no
evidence
that
cypermethrin
induces
endocrine
disruption.

EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
EPA
include
evaluations
of
potential
effects
in
wildlife.
For
pesticides,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
In
the
available
toxicity
studies
on
cypermethrin
submitted
for
registration
purposes,
there
was
no
estrogen,
androgen,
and/
or
thyroid
mediated
toxicity.
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
EDSP
have
been
developed,
cypermethrin
may
be
subject
to
additional
screening
and/
or
testing.

3.
Cumulative
Risks
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,
available
data
shows
that
there
are
multiple
types
of
sodium
channels
and
that
these
compounds
may
act
on
different
isoforms
of
the
sodium
channel
and
with
other
ion
channels
in
producing
their
clinical
signs.
It
is
currently
unknown
whether
the
pyrethroids
as
a
class
have
similar
effects
on
all
channels
or
whether
modifications
of
different
types
of
sodium
channels
would
have
a
cumulative
effect.
Nor
do
we
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function
e.
g.,
nerve
excitability,
or
how
these
key
events
interact
to
produce
their
compound
specific
patterns
of
neurotoxicity.
Without
such
understanding,
there
is
no
basis
to
make
a
common
mechanism
of
toxicity
finding.
Therefore,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids
because
the
Agency
has
determined
further
study
is
needed
regarding
the
assumptions
of
dose
additivity
and
common
mechanism(
s)
of
toxicity
to
appropriately
identify
a
group
or
subgroups
for
such
an
assessment.
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.
The
Agency
anticipates
the
majority
of
this
research
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/.
Page
43
of
79
D.
Tolerance
Reassessment
Summary
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
cypermethrin
residues
in/
on
various
plant
and
livestock
commodities.
The
Codex
and
U.
S.
tolerances
are
in
harmony
with
respect
to
MRL/
tolerance
expression.
Both
regulate
the
parent
compound,
cypermethrin.

Special
efforts
to
increase
harmony
between
recommended
US
tolerance
levels
and
Codex
MRLs
were
made
for
the
following
commodities:
1)
poultry,
meat
(
0.05
ppm
instead
of
no
tolerance),
and
2)
meat
of
cattle,
goat,
sheep,
and
horse
(
0.20
instead
of
0.05
ppm).
The
following
conclusions
can
be
made
regarding
efforts
to
harmonize
the
U.
S.
tolerances
with
the
Codex
MRLs
with
respect
to
MRL/
tolerance
level:
(
i)
compatibility
between
the
U.
S.
tolerances
and
Codex
MRLs
exists
for
bulb
onions;
meat
byproducts;
poultry,
meat;
and
meat
of
cattle,
goat,
sheep,
and
horse;
and
(
ii)
incompatibility
of
the
U.
S.
tolerances
and
Codex
MRLs
remains
for
Brassica
vegetables,
cottonseed,
lettuce,
and
milk,
because
of
differences
in
good
agricultural
practices
and
determination
of
secondary
residue
levels
in
livestock
commodities.
No
questions
of
compatibility
exist
with
respect
to
commodities
where
Codex
MRLs
have
been
established
but
U.
S.
tolerances
do
not
exist,
or
vice
versa.

A
summary
of
cypermethrin
tolerance
reassessments
is
presented
in
Table
14.

Table
14.
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
Cattle,
meat
0.05
0.20
Harmonize
with
Codex
MRL
Cattle,
mbyp
0.05
0.05
[
Cattle,
meat
byproducts]

Cottonseed
0.5
0.50
[
Cotton,
undelinted
seed]

Goats,
fat
0.05
1.0
[
Goat,
fat]

Goats,
meat
0.05
0.20
[
Goat,
meat]
Harmonize
with
Codex
MRL
Goats,
mbyp
0.05
0.05
[
Goat,
meat
byproducts]

Hogs,
fat
0.05
0.10
[
Hog,
fat]

Hogs,
meat
0.05
0.05
[
Hog,
meat]

Hogs,
mbyp
0.05
 
Residue
data
support
removal
of
tolerance.

Horses,
fat
0.05
1.0
[
Horse,
fat]
Page
44
of
79
Table
14.
Tolerance
Reassessment
Summary
for
Cypermethrin.

Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/
Correct
Commodity
Definition
Horses,
meat
0.05
0.20
[
Horse,
meat]
Harmonize
with
Codex
MRL
Horses,
mbyp
0.05
0.05
[
Horse,
meat
byproducts]

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

Milk
0.05
2.5
[
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
Sheep,
meat
0.05
0.20
Harmonizes
with
Codex
MRL
Sheep,
mbyp
0.05
0.05
[
Sheep,
meat
byproducts]

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

Cotton
gin
byproducts
­­
11
Egg
 
0.05
Poultry,
fat
 
0.05
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
Updated
dietary
burden
supports
lower
tolerance
level.

Hog,
meat
0.2
0.05
Updated
dietary
burden
supports
lower
tolerance
level.

Hog,
meat
byproducts
0.05
None
Updated
dietary
burden
eliminates
need
for
tolerance.

Lettuce,
head
10.00
None
Covered
by
Vegetable,
leafy,
except
Brassica,
group
04.

Poultry,
meat
byproducts
0.05
None
Updated
dietary
burden
eliminates
need
for
tolerance.

E.
Regulatory
Rationale
The
Agency
has
determined
that
cypermethrin
is
eligible
for
reregistration
provided
that
the
risk
mitigation
measures
and
label
amendments
specified
in
this
RED
are
implemented.
The
Page
45
of
79
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
use
of
cypermethrin.

1.
Human
Health
Risk
Mitigation
a.
Dietary,
drinking
water,
residential,
and
aggregate
risk
mitigation
Cypermethrin
dietary
(
food
+
drinking
water),
residential,
and
aggregate
risks
were
below
the
Agency's
level
of
concern.
Moreover,
the
risk
assessments
are
protective
of
the
general
U.
S.
population
and
all
population
subgroups,
including
infants
and
young
children.
Therefore,
no
mitigation
is
necessary
for
these
scenarios.

b.
Worker
risk
mitigation
i.
Handler
risk
mitigation
A
number
of
application
scenarios
involving
aerial,
ground,
or
handheld
equipment
result
in
risks
above
EPA's
level
of
concern
(
MOE
<
100
or
ARI
<
1).
The
following
mitigation
measures
are
necessary
to
address
occupational
risks
that
exceed
the
Agency's
level
of
concern:

Mixing,
loading
and
applying
liquid
formulations
For
motorized
ground
and
aerial
equipment,
risks
are
below
EPA's
level
of
concern
at
baseline
and
therefore,
no
mitigation
is
needed.
For
handheld
application
equipment,
risks
are
below
the
level
of
concern
with
the
addition
of
chemical
resistant
gloves.

 
For
liquid
formulations,
chemical­
resistant
gloves
are
required
for
all
hand­
held
application
methods.

Mixing,
loading
and
applying
wettable
powder
formulations
 
For
wettable
powder
formulations,
all
products
must
be
repackaged
in
water
soluble
bags.
 
For
wettable
powder
formulations,
chemical­
resistant
gloves
are
required
for
all
handheld
application
methods.

One
registrant
with
a
wettable
powder
product
for
use
in
industrial,
commercial,
and
residential
settings
has
requested
to
reformulate
their
product
into
a
dry
flowable
or
prill
formulation,
rather
than
repackaging
it
into
water
soluble
bags.
Although
risks
can
not
be
calculated
due
to
lack
of
exposure
data
for
dry
flowables,
EPA
is
confident
that
the
risks
to
mixer,
loader,
and
applicators
of
dry
flowables
products
would
be
lower
than
those
for
liquid
products,
and
thus
below
the
Agency's
level
of
concern
with
the
addition
of
chemical
resistant
gloves.

 
For
dry­
flowable
or
prill
formulations,
chemical­
resistant
gloves
are
required
for
all
hand­
held
application
methods.
Page
46
of
79
Additional
mitigation
for
aerial
applications
 
Closed
cockpits
are
required.
 
Human
flagging
is
prohibited.

The
human
health
assessment
estimated
risks
to
mixers,
loaders
and
applicators
making
groundboom
and
aerial
applications
to
sod
farms
at
0.74
lbs
a.
i./
A.
Application
to
sod
farms
is
allowed
through
two
Special
Local
Need
registrations
(
FL
SLN
890033,
and
CA
SLN
840214).
The
Florida
SLN
allows
application
to
Anheuser
Busch
sod
farms
using
a
soil
injection
rig
only.
The
registrant
(
Syngenta)
has
been
unable
to
verify
whether
or
not
this
SLN
is
still
in
use
and
is
not
opposed
to
canceling
it,
since
it
is
still
tied
to
a
former
registrant's
product
and
has
never
been
updated
to
reflect
the
change
of
product
ownership.
In
any
case,
EPA
does
not
anticipate
risks
of
concern
to
human
health
(
or
aquatic
organisms)
from
this
soil
injection
use
on
sod
farms.
The
California
SLN
allows
both
groundboom
and
aerial
application
to
sod
farms.
The
registrant
(
FMC)
has
no
record
of
this
SLN
and
does
not
think
it
is
currently
active.

 
Withdraw
FL
SLN
890033
and
CA
SLN
840214,
for
use
on
sod
farms
Mixing,
loading
and
applying
granular
formulations
In
February
2006,
a
granular
product
was
registered
for
use
on
lawns
and
outside
of
homes
to
kill
fire
ants
(
application
to
fire
ant
mounds).
Although
no
data
were
available
to
assess
the
risks
of
this
use
for
cypermthrin,
the
Agency
believes
that
the
risks
from
this
granular
cypermethrin
product
will
not
exceed
those
for
liquid
products,
which
are
below
EPA's
level
of
concern
for
this
scenario.
No
mitigation
is
needed
for
this
use.

Applying
ready­
to­
use
(
RTU)
formulations
No
risks
exceeded
EPA's
level
of
concern,
and
no
mitigation
is
needed.

ii.
Post­
application
risk
mitigation
Agricultural
uses
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.

 
As
per
the
Worker
Protection
Standard,
a
restricted­
entry
interval
of
12
hours
is
required
for
agricultural
uses.

Non­
agricultural
(
industrial,
commercial,
and
residential)
uses
Page
47
of
79
EPA
did
not
assess
occupational
post­
application
exposures
and
risks
following
applications
to
residential
and
commercial
lawns,
and
in
and
around
industrial,
commercial,
and
residential
premises,
since
no
short­
or
intermediate­
term
dermal
endpoints
of
concern
were
identified
and
long­
term
exposures
are
not
expected
for
tasks
involving
any
of
the
registered
use
patterns.

 
No
new
mitigation
is
required,
but
existing
precautionary
label
statements
and
use
directions
intended
to
be
protective
of
human
health
must
be
retained
(
see
label
table
in
Section
V.
for
examples).

iii.
Additional
recommendations
based
on
incident
reports
Based
on
documented
incident
reports
involving
cypermethrin,
skin
and
eye
protection
is
recommended
for
agricultural
handlers
making
broadcast
applications.
Bystanders
should
vacate
indoor
areas
receiving
treatment
and
the
area
should
be
appropriately
ventilated
afterwards
before
persons
reenter
the
premises.
Further
study
is
needed
to
determine
whether
labels
should
advise
of
potential
allergy
or
asthma­
like
problems
among
sensitive
individuals.

2.
Environmental
Risk
Mitigation
The
Agency
has
conducted
a
screening­
level
ecological
and
environmental
risk
assessment
for
the
registered
agricultural
uses
of
cypermethrin.
Based
on
the
available
data,
the
Agency
has
identified
potential
acute
risks
of
concern
to
freshwater
and
estuarine/
marine
invertebrates
and
fish,
benthic
organisms,
mammals,
earthworms,
and
non­
target
insects,
and
potential
chronic
risks
of
concern
to
freshwater
and
estuarine/
marine
invertebrates,
benthic
organisms,
and
mammals.

Risk
from
non­
agricultural
uses
of
cypermethrin
could
not
be
quantitatively
assessed
at
this
time,
but
is
expected
based
on
the
risks
from
agricultural
uses,
the
high
proportion
of
use
of
cypermethrin
in
outdoor
non­
agricultural
areas
(
e.
g.
for
nuisance
pest
control
around
structures
and
on
lawns,
and
as
a
pre­
construction
termiticide),
and
the
limited
existing
data
showing
the
presence
of
cypermethrin
in
California
urban
creeks
at
concentrations
toxic
to
benthic
invertebrates.
Mitigation
to
address
the
ecological
risks
from
agricultural
and
non­
agricultural
cypermethrin
applications
is
described
below.

a.
Mitigation
to
Address
Risks
to
Non­
Target
Organisms
from
Agricultural
Uses
To
address
ecological
risks
from
agricultural
uses
of
cypermethrin,
the
following
mitigation
measures
are
required:

Decrease
total
yearly
application
rates,
and
increase
re­
treatment
intervals
The
maximum
rate
per
application
will
be
maintained
at
0.1
lbs
a.
i./
A
for
all
crops.
However,
the
following
changes
will
be
made
to
reduce
the
frequency
of
application
and
total
pounds
applied
per
year:
Page
48
of
79
For
cotton:
 
Limit
the
total
amount
of
product
applied
to
0.4
lbs
ai/
A/
year
(
reduced
from
0.6
lbs
ai/
A/
year).
 
Increase
the
minimum
re­
treatment
interval
to
5
days
(
increased
from
3
days).

For
pecans:
 
Limit
the
total
amount
of
product
applied
to
0.5
lbs
ai/
A/
year
(
reduced
from
0.6
lbs
ai/
A/
year).
 
Establish
a
minimum
re­
treatment
interval
of
7
days.

For
head
lettuce,
head
and
stem
brassicas
(
such
as
broccoli),
leafy
brassicas
(
such
as
canola),
and
bulb
vegetables
(
such
as
onions):
 
Limit
the
total
amount
of
product
applied
to
0.6
lbs
ai/
A/
year.
 
Establish
a
minimum
re­
treatment
interval
of
7
days.

Prohibit
high­
rate,
high­
ecological­
impact
use
sites
 
Remove
the
use
sites:
agricultural
uncultivated
areas,
fencerows,
and
hedgerows
(
application
rate
of
3.4
lbs
ai/
A)
from
product
labels,
and
prohibit
use
on
these
sites
 
Prohibit
use
on
rights­
of­
way
 
Prohibit
use
on
sod
farms
Require
the
following
mitigation
to
reduce
spray
drift
from
agricultural
applications
EPA
understands
the
history
of
spray
drift
language
development
with
the
Pyrethroid
Working
Group
(
PWG),
and
the
desire
of
registrants
to
maintain
a
level
playing
field
among
the
pyrethroids
with
respect
to
spray
drift
restrictions.
Since
the
current
spray
drift
labeling
for
pyrethroids
is
over
ten
years
old,
EPA
would
like
to
update
it
as
described
below
and
in
chapter
5
of
this
RED,
and
have
all
PWG
pyrethroid
products
adopt
these
restrictions
by
early
2007.
EPA
is
willing
to
meet
with
the
PWG
to
discuss
any
issues
concerning
these
spray
drift
label
statements,
and
welcomes
comments
from
other
stakeholders
during
the
60­
day
post­
RED
comment
period.

 
For
groundboom
and
aerial
applications,
use
medium
or
coarser
spray
nozzles
 
For
motorized
ground
or
aerial
applications,
apply
only
when
the
wind
velocity
is
3
to
10
mph
for
all
crops
other
than
cotton;
for
cotton,
apply
only
when
the
wind
velocity
is
3
to
15
mph
 
Do
not
make
ground
or
aerial
applications
during
temperature
inversions
 
For
airblast
applications
to
tree
crops,
direct
spray
into
the
canopy,
and
turn
off
outward
pointing
nozzles
at
row
ends
and
when
spraying
outer
two
rows
 
For
groundboom,
chemigation,
or
airblast
applications,
do
not
apply
within
25
feet
of
water
bodies
or
aquatic
habitat
 
For
aerial
applications,
do
not
apply
within
150
feet
of
water
bodies
or
aquatic
habitat;
increase
this
no
spray
buffer
zone
to
450
feet
when
making
an
ultra
low
volume
(
ULV)
application
Page
49
of
79
 
For
aerial
applications,
do
not
release
spray
at
a
height
greater
than
10
feet
above
the
ground
or
crop
canopy,
when
spraying
within
1000
feet
of
water
bodies
or
aquatic
habitat
See
Section
V
and
the
label
table
for
required
spray
drift
label
statements.

Require
the
following
mitigation
to
reduce
run­
off
from
agricultural
fields
 
Construct
and
maintain
a
10­
foot­
wide
vegetative
filter
strip
of
grass
or
other
permanent
vegetation
between
the
field
edge
and
any
water
body
or
aquatic
habitat
(
USDA,
NRCS.
2000.
Conservation
Buffers
to
Reduce
Pesticide
Losses.
Natural
Resources
Conservation
Service.
Fort
Worth,
Texas.)

c.
Mitigation
to
Address
Risks
to
Non­
Target
Organisms
from
Non­
Agricultural
Uses
Estimating
risk
from
non­
agricultural
uses
of
pyrethroids
The
Office
of
Pesticide
Programs
(
OPP)
strives
to
estimate
pesticide
exposure
through
all
significant
routes
of
exposure
from
both
agricultural
and
non­
crop
uses.
However,
the
ecological
risk
assessments
for
pyrethroid
insecticides
focus
predominantly
on
the
agricultural
uses
for
these
insecticides,
because
pesticide
transport
models
are
available
to
estimate
potential
aquatic
exposure.
Based
on
laboratory
toxicity
tests
with
terrestrial
and
aquatic
animals,
aquatic
exposure
would
be
more
likely
to
cause
adverse
effects
in
the
environment.

However,
sales
data
indicate
that
non­
crop
uses
of
the
pyrethroids
comprise
a
much
larger
fraction
of
total
use
than
agricultural
uses.
The
use
of
pyrethroids
in
urban
and
suburban
settings
has
increased
since
the
phase­
out
of
these
uses
of
the
organophosphate
insecticides
diazinon
and
chlorpyrifos.
Sales
data
indicate
that
the
majority
of
urban
use
of
cypermethrin
is
for
structural
pest
control,
such
as
for
control
of
termites
or
ants.
Other
outdoor
non­
crop
uses
include
landscape
maintenance,
and
homeowner
lawn
and
garden
use.
Indoor
uses
include
nuisance
insect
control,
and
termite
applications.

For
pyrethroids
with
relevant
indoor
uses
(
not
including
cypermethrin),
the
Agency
uses
a
"
down­
the­
drain"
model
to
perform
a
screening­
level
aquatic
risk
assessment.
In
these
simulations,
waste
water
containing
pesticide
residue
flows
into
a
building
drain
and
passes
through
a
sanitary
sewer
and
publicly
owned
treatment
works
(
POTW)
before
being
discharged
to
surface
water.
However,
no
analogous
exposure
model
has
been
developed
to
allow
a
similar
screening­
level
assessment
for
pesticides
applied
in
an
outdoor
urban
setting,
like
cypermethrin.
As
a
result,
the
Agency
has
had
to
take
a
qualitative
approach
to
characterize
the
potential
aquatic
risk
from
urban
and
suburban
use
of
pyrethroids.

For
outdoor
urban
uses,
it
is
assumed
that
runoff
water
from
rain
and/
or
lawn
watering
may
transport
pesticides
to
storm
sewers
and
then
directly
to
surface
water.
Conceptually,
a
greater
contribution
to
pyrethroid
loading
to
surface
water
bodies
would
be
expected
from
application
to
impervious
surfaces
such
as
walkways,
driveways
or
the
sides
of
buildings,
than
to
lawns
or
bare
ground,
because
of
the
pyrethroids'
strong
affinity
to
bind
to
organic
carbon
in
soils.
However,
Page
50
of
79
the
Agency
is
unaware
of
any
model
which
can
simulate
the
different
application
methods
for
urban
use
and
the
physical
representation
of
the
urban
landscape,
storm
sewer
and
receiving
water
configuration.

There
are
models
available
which
can
be
calibrated
to
simulate
sites
and
pesticides
for
which
extensive
flow
and
pollutant
data
have
been
collected
in
advance.
The
HSPF/
NPSM
model,
for
instance,
which
is
included
in
the
Office
of
Water's
BASINS
shell,
has
been
used
to
calibrate
stream
flow
and
copper
pesticide
use
data
to
simulate
loading
of
these
pesticides
consistent
with
concentrations
measured
in
surface
water
monitoring.
Risk
assessors
with
the
California
Department
of
Environmental
Protection
confirmed
in
conversations
with
the
Agency
that
they
also
have
used
watershed
models
to
calibrate
to
previously
collected
flow
and
pesticide
monitoring
data,
but
that
they
did
not
know
of
any
models
capable
of
predicting
concentrations
of
pyrethroids
that
might
occur
because
of
outdoor
urban
uses.

Development
of
a
screening
model
which
could
simulate
the
fate
and
transport
of
pesticides
applied
in
an
urban
setting
would
require
a
large
body
of
data
which
is
currently
unavailable.
For
instance,
an
urban
landscape
cannot
be
simulated
as
easily
as
an
agricultural
field.
The
PRZM
model
simulates
runoff
from
an
agricultural
field
using
readily
available
data
describing
surface
soil
characteristics
and
laboratory
data
detailing
the
persistence
and
mobility
of
pesticides
in
these
soils.
The
agricultural
field
simulated
is
homogenously
planted
to
a
single
crop,
and
soil
and
water
are
transported
from
the
field
to
a
receiving
water
body
with
dimensions
consistent
with
USDA
farm­
pond
construction
guidelines.

By
contrast,
an
urban
landscape
or
suburban
housing
development
consists
of
impervious
surfaces
such
as
streets
and
sidewalks,
and
pervious
surfaces
such
as
lawns
and
parkland.
One
could
expect
much
greater
mobility
for
pesticides
applied
to
impervious
surfaces,
but
laboratory
soil
metabolism
studies
may
not
provide
an
accurate
measure
of
the
persistence
of
pesticides
on
these
surfaces.
The
path
runoff
water
and
eroded
sediment
might
take
is
less
obvious
for
an
urban
setting
than
an
agricultural
field.
First,
an
urban
landscape
cannot
be
considered
homogeneous,
as
the
proportion
of
impervious
and
pervious
surfaces
varies
for
different
locations.
In
addition,
the
flow
path
of
runoff
water
and
sediment
is
not
necessarily
a
direct
path
over
land,
but
can
pass
below
ground
through
storm
sewer
networks,
or
be
directed
or
slowed
by
pumping
stations
or
temporary
holding
ponds.

Finally,
the
timing
and
magnitude
of
urban
uses
is
less
well
defined
for
urban
uses
than
agricultural
uses.
While
agricultural
uses
would
occur
within
a
predictable
window
during
the
growing
season,
the
need
for
urban
uses
could
occur
at
different
times
each
year,
and
might
occur
at
different
times
within
the
same
watershed.
In
addition,
since
records
of
how
and
to
what
extent
pyrethroids
are
applied
by
homeowners
are
less
well
defined
than
for
professional
applications,
it
is
harder
to
estimate
the
total
load
to
model.

Pyrethroid
monitoring
data
The
Agency
considers
surface
water
monitoring
data
in
addition
to
modeling
results
when
they
are
available.
However,
surface
water
monitoring
for
pyrethroids
has
been
limited,
perhaps
because
the
pyrethroids
would
more
likely
be
associated
with
aquatic
sediment
than
the
water
Page
51
of
79
column.
The
USGS
NAWQA
program
included
permethrin
(
another
pyrethroid
currently
undergoing
reregistration)
as
the
only
pyrethroid
among
its
pesticide
analytes,
and
detected
it
in
0.15%
of
1185
agricultural
stream
samples
from
78
sample
locations.
Permethrin
was
not
detected
in
803
urban
stream
samples
taken
from
33
sample
locations.
The
NAWQA
program
also
analyzed
for
cis­
permethrin
in
bed
sediments,
and
had
similar
detection
rates
in
between
the
agricultural
(
1.5%)
and
urban
(
1.0%)
land
use
sites;
trans­
permethrin
was
detected
in
0.8%
of
bed
sediment
samples.

More
recently,
researchers
from
the
University
of
California­
Berkeley
have
published
studies
which
reported
transport
of
pyrethroids
to
stream
bed
sediment
as
a
result
of
urban
uses.
In
2004,
Weston,
et
al.
collected
sediment
from
creeks
draining
a
residential
area
in
Rosedale,
California.
The
sediments
were
analyzed
for
7
pyrethroids
(
including
cypermethrin
and
permethrin),
as
well
as
for
other
insecticides.
All
of
the
pyrethroids
were
detected
in
the
bed
sediment
from
at
least
one
sampling
location.
The
researchers
exposed
the
aquatic
amphipod
Hyalella
azteca
to
the
21
sediment
samples
they
collected;
pesticide
concentrations
in
9
of
these
samples
was
sufficient
to
cause
90%
mortality
in
the
amphipods
after
a
10­
day
exposure.
The
concentrations
of
pyrethroids
detected
in
the
sediments
were
above
the
level
expected
to
cause
50%
mortality
in
H.
azteca,
suggesting
that
the
pyrethroids
were
responsible
for
the
observed
toxicity.

In
a
subsequent
study,
Weston,
et
al.
collected
samples
from
15
urban
creeks
in
California
and
12
in
Tennessee.
Toxicity
to
H.
azteca
was
observed
at
least
once
with
sediments
taken
from
12
of
the
15
California
sampling
sites.
In
most
cases,
the
toxicity
could
be
accounted
for
by
the
concentrations
of
pyrethroids
detected
in
the
sediment.
Pyrethroids
were
rarely
detected
in
the
Tennessee
sediment
samples,
and
exposure
to
the
Tennessee
sediments
did
not
prove
to
be
toxic
to
H.
azteca.

Future
steps
The
results
of
the
Weston,
et
al.
studies
has
led
a
number
of
organizations,
such
as
the
California
State
Water
Resources
Control
Board
(
SWRCB)
to
submit
comments
to
the
Agency
during
the
reregistration
process
of
several
pyrethroid
insecticides,
calling
for
mitigation
measures
to
prevent
pyrethroid
surface­
water
contamination.
However,
the
lack
of
knowledge
which
makes
it
difficult
to
develop
an
urban
pesticide
transport
model
also
makes
it
difficult
to
identify
meaningful
mitigation
at
this
time.
The
Agency
has
developed
some
initial
mitigation
options
during
the
reregistration
process,
and
intends
to
identify
steps
which
can
be
taken
to
allow
a
greater
understanding
of
potential
ecological
risk
from
urban
pyrethroid
uses.

One
reason
that
broad
mitigation
measures
cannot
be
adopted
during
reregistration
is
that
only
three
pyrethroid
insecticides
are
required
to
be
reviewed
for
reregistration
in
accordance
with
FQPA.
If
use
restrictions
were
placed
on
one
of
these
three
pesticides,
one
of
the
other
pyrethroids
would
likely
replace
it
for
that
use.
It
is
important,
as
some
commenters
have
suggested,
to
perform
a
risk
assessment
for
all
of
the
pyrethroids
at
the
same
time.
The
Weston
papers
indicated
that
the
sediments
which
proved
toxic
to
the
tested
aquatic
invertebrate
were
contaminated
not
only
with
the
pyrethroids
undergoing
reregistration,
but
also
other
pyrethroids
such
as
bifenthrin
and
lambda­
cyhalothrin.
Page
52
of
79
The
next
opportunity
to
assess
the
pyrethroids
as
a
group
will
occur
during
the
Registration
Review
program,
for
which
the
Agency
issued
a
proposed
rule
in
July
2005
and
plans
to
issue
the
final
rule
and
implement
the
program
in
2006.
The
purpose
of
Registration
Review
is
to
ensure
the
periodic
review
of
all
pesticides
to
make
sure
they
continue
to
meet
current
scientific
and
regulatory
requirements,
with
the
goal
of
reviewing
each
pesticide
every
fifteen
years.
The
pyethroids
are
tentatively
scheduled
for
re­
evaluation
under
the
proposed
Registration
Review
program
in
2010.

A
number
of
steps
are
planned
for
the
intervening
years
which
should
improve
the
Agency's
ability
to
assess
the
level
of
aquatic
exposure
to
pyrethroids
from
urban
use.
One
step
is
to
better
identify
what
conditions
in
an
urban
setting
might
lead
to
greater
vulnerability
to
transport
to
urban
water
bodies.
Although
the
Weston
papers
reported
sediment
toxicity
from
samples
from
California
but
not
Tennessee,
the
authors
could
only
speculate
what
differences
in
use
or
geography
made
an
area
more
vulnerable
to
exposure
than
the
other.

Further
investigation
into
the
dominant
urban
uses
and
application
practices
of
pyrethroids
around
the
country
would
help
provide
a
clearer
picture
of
relative
vulnerability.
The
SWRCB
commented
that
structural
pest
control
is
likely
a
major
source
of
pyrethroids
in
urban
runoff,
and
suggested
best
management
practices
(
BMP).
The
Pyrethroid
Working
Group
(
PWG)
indicated
that
irrigation
of
lawns
in
areas
of
California
with
little
rainfall
during
the
application
season
could
be
a
major
contributor,
and
has
contacted
organizations
such
as
Responsible
Industry
for
a
Sound
Environment
(
RISE)
and
the
Coalition
for
Urban/
Residential
Environmental
Stewardship
(
CURES)
to
develop
BMPs
as
part
of
their
product
stewardship
plan.
As
further
sediment
monitoring
studies
are
published
describing
parts
of
the
country
with
different
weather
and
pest
pressures,
more
detailed
usage
data
will
make
it
easier
to
correlate
the
causes
of
pyrethroid
use
practices.

The
Agency
will
also
continue
in
its
efforts
to
develop
a
screening­
level
model
for
urban
pesticide
uses.
Advances
in
the
resolution
of
GIS
databases
may
allow
better
representation
of
the
impervious
and
pervious
portions
of
a
typical
urban
landscape.
As
it
becomes
clearer
which
uses
are
most
likely
to
lead
to
transport
of
pyrethroids
to
surface
water,
the
conceptual
model
of
how
urban
transport
should
be
simulated
will
be
more
focused.

Finally,
the
Agency
will
evaluate
available
published
literature
and
call­
in
data
to
resolve
data
gaps
to
ensure
a
robust
comparison
of
the
potential
ecological
risk
of
all
the
pyrethroids
during
Registration
Review.
Toxicity
data
cited
by
several
commenters
from
published
literature
are
included
in
the
Agency's
ECOTOX
database.
The
Agency
will
evaluate
the
quality
of
studies
to
identify
those
to
be
included
in
the
risk
assessments
during
Registration
Review.
The
PWG
has
performed
some
toxicity
studies
identified
by
the
Agency
as
data
gaps,
such
as
sediment
invertebrate
toxicity
tests
and
those
studies
are
in
review.

Interim
mitigation
required
for
reregistration
Until
the
Agency
can
perform
a
quantitative
risk
assessment
for
the
non­
agricultural
uses
of
cypermethrin,
the
Agency
believes
that
certain
interim
mitigation
measures
are
warranted.
These
mitigation
measures
are
intended
to
reduce
the
runoff
and
drainage
to
storm
sewers,
surface
Page
53
of
79
water,
and
aquatic
habitats
associated
with
the
current
industrial,
commercial,
and
residential
uses
of
cypermethrin,
and
to
address
potential
risks
to
aquatic
organisms
from
these
existing
use
patterns.
These
mitigation
measures
should
also
help
to
reduce
off­
site
exposure
and
risk
to
terrestrial
organisms.

To
reduce
runoff
and
drift
to
water
bodies,
and
to
address
potential
ecological
risks
from
nonagricultural
(
industrial,
commercial,
and
residential)
uses
of
cypermethrin,
the
following
mitigation
measures
are
required:

For
products
with
indoor
and/
or
outdoor
nuisance
pest
control
uses
(
other
than
termiticides)

 
Limit
all
outdoor
non­
termite
applications
to
spot
and
crack­
and­
crevice
applications,
only,
except
for
the
following
barrier,
perimeter,
band
or
broadcast
spray
applications,
which
are
permitted:
(
1)
Barrier,
perimeter
or
band
applications
to
soil
or
vegetation
around
structures;
(
2)
Broadcast
applications
to
vegetated
residential
or
commercial
landscapes,
including
lawns
and
turf;
(
3)
Band
applications
to
building
foundations,
up
to
a
maximum
height
of
3
feet.
Other
than
number
(
3),
above,
all
outdoor
non­
termite
applications
to
impervious
surfaces
such
as
sidewalks,
driveways,
patios,
porches
and
structural
surfaces
(
such
as
windows,
doors,
and
eaves)
are
limited
to
spot
and
crack­
and­
crevice
applications,
only.
 
Reduce
the
maximum
broadcast
application
rate
for
residential,
commercial,
and
industrial
lawns
to
0.44
lbs
ai/
A
(
0.0101
lbs
ai/
1000
ft2)
for
all
formulations.
(
Maximum
rate
was
0.74
lbs
ai/
A).
 
For
outdoor
uses,
do
not
apply
within
10
feet
of
storm
drains.
Do
not
apply
within
25
feet
of
rivers,
fish
ponds,
lakes,
streams,
reservoirs,
marshes,
estuaries,
bays,
or
oceans.
 
Prohibit
application
directly
into
drains,
or
to
any
area
where
drainage
to
storm
sewers,
water
bodies,
or
aquatic
habitat
can
occur.
When
making
an
application
around
or
near
a
floor
drain,
limit
the
application
to
a
spot
treatment
and
do
not
allow
the
product
to
enter
the
drain
during
or
after
the
application.
The
use
site
"
Application
around
or
near
floor
drains"
should
be
listed
separately
from
other
indoor
use
sites
on
the
label,
with
these
restrictions.
 
Broadcast
applications
to
exterior
surfaces
of
boats
are
prohibited.
Applications
to
exterior
surfaces
of
boats
are
limited
to
spot
treatments,
only.
Use
inside
boats,
ships,
and
other
vessels
is
permitted.
Do
not
allow
product
to
drain
or
wash
off
into
water
bodies
or
aquatic
habitat.
The
use
site
"
Application
in
and
on
boats"
should
be
listed
separately
from
other
use
sites
on
the
label,
with
these
restrictions.
 
Cover
any
water
inhabited
by
fish
(
such
as
aquariums
and
ornamental
fish
ponds)
during
treatment,
and
turn
aquarium
systems
off.
 
Remove
birds
and
other
pets.
Do
not
allow
pets
to
enter
treated
areas
or
contact
treated
surfaces
until
sprays
have
dried.
 
Do
not
apply
when
windy
(
sustained
wind
speeds
or
gusts
above
10
mph).
 
After
application,
do
not
over­
water
the
treated
area
to
the
point
of
runoff.
Do
not
apply
when
raining
or
when
rain
is
expected
within
8
hours.
Page
54
of
79
 
Rinse
application
equipment
over
lawn
or
garden
area
only.
Do
not
allow
rinse
water
to
flow
into
drains
(
including
storm
drains),
street
gutters,
sewers,
drainage
ditches,
water
bodies,
or
aquatic
habitat.

Comments
were
received
concerning
use
of
cypermethrin
in
"
swimming
pool
water
systems."
Application
to
swimming
pool
water
systems,
or
to
swimming
pools
in
general,
is
not
a
labeled
use
of
cypermethrin.
Cypermethrin
may
be
applied
as
a
broadcast
treatment
to
lawns
and
other
vegetated
areas
around
swimming
pools,
or
as
a
spot
or
crack­
and­
crevice
treatment
to
impermeable
surfaces
(
such
as
tiled
walkways)
around
pools.

A
granular
product
was
registered
on
February
23,
2006
(
EPA
registration
#
28293­
367).
This
product
is
for
application
to
fire
ant
mounds
on
lawns
and
outside
of
homes.
EPA
does
not
believe
that
this
product,
when
used
according
to
label
directions
(
very
limited,
targeted
use),
presents
a
risk
of
concern
to
non­
target
organisms.

For
pre­
construction
subterranean
termite
control
During
the
phase
3
comment
period
for
cypermethrin,
EPA
received
comments
from
California
water
regulatory
agencies
concerning
the
potential
for
runoff
and
aquatic
risk
from
preconstruction
(
non­
injected)
termite
applications.
Commenters
also
submitted
label
statements
for
this
use.
After
receiving
input
from
the
Association
of
Structural
Pest
Control
Regulatory
Officials
(
ASPCRO),
EPA
developed
the
proposed
label
statements
listed
below.
EPA
would
like
to
invite
further
stakeholder
input
on
these
statements
during
the
post­
RED
comment
period
for
cypermethrin.

(
1)
If
concrete
slabs
cannot
be
poured
over
the
treated
soil
on
the
day
of
application,
the
treated
soil
must
be
covered
with
a
waterproof
covering
(
such
as
polyethylene
sheeting).

(
2)
Do
not
treat
soil
that
is
water­
saturated
or
frozen.
Do
not
treat
when
raining
or
when
rain
is
expected
within
8
hours.
All
treated
areas
must
covered
(
with
a
waterproof
covering)
before
it
starts
to
rain.
If
a
waterproof
cover
is
used,
storm
water
runoff
must
be
diverted
around
the
treatment
area
to
prevent
water
from
contacting
or
collecting
in
the
treatment
area.

(
3)
Do
not
apply
within
10
feet
of
storm
drains.
Do
not
apply
within
25
feet
of
rivers,
fish
ponds,
lakes,
streams,
reservoirs,
marshes,
estuaries,
bays,
or
oceans.

(
4)
Do
not
make
on­
grade
applications
when
sustained
wind
speeds
or
gusts
are
above
10
mph.

c.
Endangered
Species
The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
(
ESA)
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
that
may
Page
55
of
79
affect
any
particular
species,
EPA
uses
basic
toxicity
and
exposure
data
developed
for
the
REDs
and
considers
it
in
relation
to
individual
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species,
as
part
of
a
refined
species­
specific
analysis.
When
conducted,
this
speciesspecific
analysis
will
take
into
consideration
any
regulatory
changes
recommended
in
this
RED
that
are
being
implemented
at
that
time.

Following
this
future
species­
specific
analysis,
a
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
or
its
critical
habitat
may
result
in:
limitations
on
the
use
of
cypermethrin,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
or
the
National
Marine
Fisheries
Service
as
necessary.
If
the
Agency
determines
use
of
cypermethrin
"
may
affect"
listed
species
or
their
designated
critical
habitat,
EPA
will
employ
the
provisions
in
the
Services
regulations
(
50
CFR
Part
402).
Until
that
species­
specific
analysis
is
completed,
the
risk
mitigation
measures
being
implemented
through
this
RED
will
reduce
the
likelihood
that
endangered
and
threatened
species
may
be
exposed
to
cypermethrin
at
levels
of
concern.
EPA
is
not
requiring
specific
cypermethrin
label
language
at
the
present
time
relative
to
threatened
and
endangered
species.
If,
in
the
future,
specific
measures
are
necessary
for
the
protection
of
listed
species,
the
Agency
will
implement
them
through
the
Endangered
Species
Protection
Program.

3.
Benefits
of
Cypermethrin
Use
and
Available
Alternatives
Pyrethrin
and
synthetic
pyrethroids,
including
cypermethrin,
cyfluthrin,
deltamethrin,
esfenvalerate,
lambda
cyhalothrin,
permethrin,
resmethrin,
sumithrin,
tetramethrin,
and
tralomethrin,
are
available
to
control
a
wide
variety
of
nuisance,
lawn
and
garden
plant,
structural,
and
public
health
arthropod
pests.
Pyrethroids
may
be
applied
inside
residential
areas
as
a
crack
and
crevice,
area,
or
spot
spray.
They
may
also
be
applied
in
areas
adjacent
to
or
surrounding
residential
areas
as
a
perimeter
treatment
to
prevent
the
movement
of
pests
into
houses
and
as
a
spot
and
yard
treatment.
Usage
data
are
sparse
and
generally
do
not
distinguish
between
chemicals
within
the
class
or
differentiate
the
amounts
used
on
various
residential
sites.
The
recent
loss
of
chlorpyrifos
and
diazinon
for
residential
pest
control
has
resulted
in
a
greater
reliance
on
pyrethrins
and
synthetic
pyrethroids,
as
a
class,
among
residential
users.
Most
pyrethroids
have
similar
efficacy
and
cost.
In
the
absence
of
any
one
pyrethroid,
homeowners
and
professional
applicators
would
most
likely
simply
substitute
another
pyrethroid
insecticide.
Users
might
also
substitute
insecticides
from
other
chemical
classes
(
e.
g.
organophosphates,
carbamates,
and
neonicotinoids)
and
nonchemical
control
techniques
(
e.
g.
sanitation
or
exclusion).
Given
the
options
for
substitution,
the
economic
impacts
of
restricting
any
one
chemical
would
not
likely
be
significant;
also,
the
impact
on
risk
of
restricting
any
one
pyrethroid
is
uncertain
and
might
increase
given
the
substitute
available.

V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
cypermethrin
is
eligible
for
reregistration
provided
that
the
mitigation
measures
and
label
changes
identified
in
this
RED
are
implemented.
Registrants
will
need
to
amend
their
product
labeling
to
incorporate
the
label
statements
set
forth
in
the
Label
Page
56
of
79
Changes
Summary
Table
(
table
16).
The
Agency
intends
to
issue
Data
Call­
Ins
(
DCIs)
requiring
generic
and
product
specific
data.
Generally,
the
registrant
will
have
90
days
from
receipt
of
a
DCI
to
complete
and
submit
response
forms
or
request
time
extensions
and/
or
waivers
with
a
full
written
justification.
For
product­
specific
data,
the
registrant
will
have
eight
months
to
submit
data
and
amended
labels.

A.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
cypermethrin
for
currently
registered
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
However,
the
data
listed
below
are
necessary
to
confirm
the
reregistration
eligibility
decision
documented
in
this
RED.

Table
15.
Guideline
Requirements
for
Cypermethrin
Data
Requirement
Old
Guideline
Number
New
OPPTS
Guideline
No.
Life­
Cycle
Aquatic
Invertebrate,
Freshwater:
72­
4
(
b)
850.1350
Additional
Residue
Chemistry
Clarifications
Other
needed
label
changes
pertain
to
the
following:
1)
minimum
retreatment
intervals,
2)
minimum
aerial
application
volumes,
and
3)
impractical
cotton
forage
grazing/
feeding
restrictions.

2.
Labeling
Requirements
To
ensure
compliance
with
FIFRA,
manufacturing
use
product
(
MUP)
labeling
should
be
revised
to
comply
with
all
current
EPA
regulations,
PR
Notices,
and
applicable
policies.
The
MUP
labeling
should
bear
the
labeling
contained
in
Table
16.

3.
Spray
Drift
Management
The
Agency
has
been
working
closely
with
stakeholders
to
develop
improved
approaches
for
mitigating
risks
to
human
health
and
the
environment
from
pesticide
spray
and
dust
drift.
As
part
of
the
reregistration
process,
the
EPA
will
continue
to
work
with
all
interested
parties
on
this
important
issue.

B.
End­
Use
Products
Additional
Product­
Specific
Data
Requirements
Section
4(
g)(
2)(
B)
of
FIFRA
calls
for
the
Agency
to
obtain
any
needed
product­
specific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
The
Registrant
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
Page
57
of
79
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
then
the
study
MRID
numbers
should
be
cited
according
to
the
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.
The
Agency
intends
to
issue
a
separate
product­
specific
data
call­
in
(
PDCI),
outlining
specific
data
requirements.
For
any
questions
regarding
the
PDCI,
please
contact
Jane
Mitchell
at
(
703)
308­
8061.

Labeling
for
End­
Use
Products
To
be
eligible
for
reregistration,
labeling
changes
are
necessary
to
implement
measures
outlined
in
Section
IV
above.
Specific
language
to
incorporate
these
changes
is
specified
in
table
16.
Generally,
conditions
for
the
distribution
and
sale
of
products
bearing
old
labels/
labeling
will
be
established
when
the
label
changes
are
approved.
However,
specific
existing
stocks
time
frames
will
be
established
case­
by­
case,
depending
on
the
number
of
products
involved,
the
number
of
label
changes,
and
other
factors.
Page
58
of
79
Labeling
Changes
Summary
Table
16
In
order
to
be
eligible
for
reregistration,
amend
all
product
labels
to
incorporate
the
risk
mitigation
measures
outlined
in
Section
IV.
The
following
table
describes
how
language
on
the
labels
should
be
amended.

Table
16.
Summary
of
Labeling
Changes
for
Cypermethrin
Description
Amended
Labeling
Language
Placement
on
Label
For
all
Manufacturing
Use
Products
"
Only
for
formulation
into
an
insecticide
for
the
following
use(
s)
[
fill
blank
only
with
those
uses
that
are
being
supported
by
MP
registrant]."

"
This
product
may
not
be
formulated
into
wettable
powder
end
use
formulations
unless
they
are
packaged
in
water
soluble
bags."
Directions
for
Use
One
of
these
statements
may
be
added
to
a
label
to
allow
reformulation
of
the
product
for
a
specific
use
or
all
additional
uses
supported
by
a
formulator
or
user
group
"
This
product
may
be
used
to
formulate
products
for
specific
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."

"
This
product
may
be
used
to
formulate
products
for
any
additional
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."
Directions
for
Use
Environmental
Hazards
Statements
Required
by
the
RED
and
Agency
Label
Policies
[
LOOK
UP
IN
LABEL
REVIEW
MANUAL]
"
This
pesticide
is
toxic
to
fish
and
aquatic
invertebrates.
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,
ponds,

estuaries,
oceans,
or
other
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance,
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA."
Precautionary
Statements
End
Use
Products
for
WPS
(
agricultural)
use
ONLY
Page
59
of
79
(
products
labeled
for
non­
agricultural
occupational
uses
must
have
separate
registrations:
see
below
for
requirements)

Restricted
Use
Pesticide
required
for
all
products.
"
RESTRICTED
USE
PESTICIDE
Due
to
Toxicity
to
Fish
and
Aquatic
Organisms.
For
retail
sale
to
and
use
only
by
certified
applicators
or
persons
under
the
direct
supervision
and
only
for
those
uses
covered
by
the
certified
applicator's
certification."

PPE
Requirements
Established
by
the
RED1
For
Wettable
Powder
(
only
wettable
powder
formulations
packaged
in
water
soluble
bags
will
be
eligible
for
reregistration).
"
Personal
Protective
Equipment
(
PPE)

Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemical­
resistant
material).
If
you
want
more
options,

follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators,
and
other
handlers
must
wear:

>
Long­
sleeve
shirt
and
long
pants,

>
Shoes
plus
socks,

>
Chemical
resistant
gloves
for
applicators
using
handheld
equipment."

"
Human
flagging
is
prohibited."

See
engineering
controls
for
additional
requirements.
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED1
For
Emulsifiable
Concentrate
"
Personal
Protective
Equipment
(
PPE)

Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemical­
resistant
material).
If
you
want
more
options,

follow
the
instructions
for
category
@
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators,
and
other
handlers
must
wear:

>
Long­
sleeve
shirt
and
long
pants,

>
Shoes
plus
socks,

>
Chemical
resistant
gloves
for
applicators
using
handheld
equipment."

"
Human
flagging
is
prohibited."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
Page
60
of
79
User
Safety
Requirements
"
Follow
manufacturer's
instructions
for
cleaning/
maintaining
PPE.
If
no
such
instructions
for
washables
exist,
use
detergent
and
hot
water.
Keep
and
wash
PPE
separately
from
other
laundry.

Discard
clothing
and
other
absorbent
materials
that
have
been
drenched
or
heavily
contaminated
with
this
product's
concentrate.
Do
not
reuse
them."
Immediately
following
the
PPE
requirements
Engineering
controls
for
Wettable
Powder
Formulations
"
Engineering
controls
Water­
soluble
packets
when
used
correctly
qualify
as
a
closed
mixing/
loading
system
under
the
Worker
Protection
Standard
for
Agricultural
Pesticides
[
40
CFR
170.240(
d)(
4)].
Mixers
and
loaders
using
water­
soluble
packets
must
:

­­
wear
the
personal
protective
equipment
required
in
the
PPE
section
of
this
labeling
for
mixers
and
loaders,
and
­­
be
provided
and
must
have
immediately
available
for
use
in
an
emergency,
such
as
a
broken
package,
spill,
or
equipment
breakdown
a
NIOSH­
approved
respirator
with:

­­
a
dust/
mist
filter
with
MSHA/
NIOSH
approval
number
prefix
TC­
21C
or
­­
any
N,
R,
P,
or
HE
filter."

Instruction
to
Registrant:
Drop
the
"
N"
type
prefilter
from
the
respirator
statement,
if
the
pesticide
product
contains,
or
is
used
with,
oil.

"
Pilots
must
use
an
enclosed
cockpit
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(
WPS)
for
agricultural
pesticides
[
40
CFR
170.240(
d)(
6)]."

"
Human
flagging
is
prohibited.
Flagging
to
support
aerial
application
is
limited
to
use
of
the
Global
Positioning
System
(
GPS)
or
mechanical
flaggers."
Immediately
following
the
User
Safety
Requirements
Engineering
controls
for
Liquids
"
Pilots
must
use
an
enclosed
cockpit
that
meet
the
requirements
listed
in
the
Worker
Protection
Standard
(
WPS)
for
agricultural
pesticides
[
40
CFR
170.240(
d)(
6)].
Immediately
following
the
User
Safety
Requirements
Page
61
of
79
"
Human
flagging
is
prohibited.
Flagging
to
support
aerial
application
is
limited
to
use
of
the
Global
Positioning
System
(
GPS)
or
mechanical
flaggers."

User
Safety
Recommendations
"
User
Safety
Recommendations
Users
should
wash
hands
with
plenty
of
soap
and
water
before
eating,

drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet.

Users
should
remove
clothing/
PPE
immediately
if
pesticide
gets
inside.

Then
wash
thoroughly
and
put
on
clean
clothing.

Users
should
remove
PPE
immediately
after
handling
this
product.
Wash
the
outside
of
gloves
before
removing.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing."
Immediately
following
Engineering
Controls
(
Must
be
placed
in
a
box.)

Environmental
Hazards
"
This
product
is
extremely
toxic
to
fish
and
aquatic
invertebrates.
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
water
mark.
Do
not
apply
when
weather
conditions
favor
drift
from
treated
areas.
Drift
and
runoff
from
treated
areas
may
be
hazardous
to
aquatic
organisms
in
neighboring
areas.
Do
not
contaminate
water
when
disposing
of
equipment
wash
waters."

"
This
pesticide
is
highly
toxic
to
bees
exposed
to
direct
treatment
or
residues
on
blooming
crops
or
weeds.
Do
not
apply
this
product
or
allow
it
to
drift
to
blooming
crops
if
bees
are
visiting
the
treatment
area."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Restricted­
Entry
Interval
for
products
with
directions
for
use
within
scope
of
the
Worker
Protection
Standard
for
Agricultural
Pesticides
(
WPS)
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(
REI)
of
12
hours."
Directions
for
Use,
In
Agricultural
Use
Requirements
Box
Early
Entry
Personal
Protective
Equipment
For
minimum
early
entry
PPE
use
the
following:

"
PPE
required
for
early
entry
to
treated
areas
that
is
permitted
under
the
Direction
for
Use,
In
Agricultural
Use
Requirements
box,
immediately
following
the
Page
62
of
79
for
products
with
directions
for
use
within
the
scope
of
the
WPS
Worker
Protection
Standard
and
that
involves
contact
with
anything
that
has
been
treated,
such
as
plants,
soil,
or
water,
is:

*
coveralls,

*
shoes
plus
socks
*
chemical­
resistant
gloves
made
of
any
waterproof
material"
REI
General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
application."
Place
in
the
Direction
for
Use
directly
above
the
Agricultural
Use
Box.

Other
Application
Restrictions
(
Risk
Mitigation)
"
Construct
and
maintain
a
10­
foot­
wide
vegetative
filter
strip
of
grass
or
other
permanent
vegetation
between
the
field
edge
and
any
water
body
or
aquatic
habitat
(
such
as
lakes,
reservoirs,
rivers,
streams,
marshes,
natural
ponds,
estuaries,
and
commercial
fish
ponds).
Refer
to
the
following
publication
for
information
on
constructing
and
maintaining
effective
vegetative
buffers:
USDA,
NRCS.
2000.
Conservation
buffers
to
Reduce
Pesticide
Losses.
Natural
Resources
Conservation
Service.
Fort
Worth,

Texas.
21
pp."

"
Use
on
sod
farms,
agricultural
uncultivated
areas,
fencerows,

hedgerows,
and
rights­
of­
way
is
prohibited."
These
use
sites
must
be
removed
from
all
product
labels.
Special
Local
Need
registrations
with
these
uses
must
be
cancelled.

Products
must
be
amended
to
reflect
the
following
maximum
application
rates
(
ai/
A),
minimum
retreatment
intervals
and
maximum
annual
application
rates
Cotton:
Maximum
application
rate
of
0.1
lb
ai/
A
Minimum
retreatment
interval
of
5
days
Maximum
seasonal
application
rate
of
0.4
lbs
ai/
A
"
Do
not
make
more
than
10
synthetic
pyrethroid
applications
(
of
one
product
or
combinations
of
products)
to
cotton
in
one
growing
season."
Directions
for
Use
Page
63
of
79
Pecans:
Maximum
application
rate
of
0.1
lb
ai/
A
Minimum
retreatment
interval
of
7
days
Maximum
seasonal
application
rate
of
0.5
lbs
ai/
A
Head
lettuce:

Maximum
application
rate
of
0.1
lb
ai/
A
Minimum
retreatment
interval
of
7
days
Maximum
seasonal
application
rate
of
0.6
lbs
ai/
A
All
other
crops:

Maximum
application
rate
of
0.1
lb
ai/
A
Minimum
retreatement
interval
of
7
days
Maximum
seasonal
application
rate
of
0.4
lbs
ai/
A
Spray
Drift
"
Spray
drift
requirements
(
1)
For
groundboom
and
aerial
applications,
use
only
Medium
or
coarser
spray
nozzles
according
to
ASABE
(
S572)
definition
for
standard
nozzles.
Aerial
applicators
must
consider
flight
speed
and
nozzle
orientation
in
determining
droplet
size.

(
2)
For
cotton:
make
aerial
or
ground
applications
when
the
wind
velocity
is
3
to
15
mph.
Do
not
apply
when
the
wind
speed
is
greater
than
15
mph.

For
all
non­
aerial
applications,
wind
speed
must
be
measured
adjacent
to
the
application
site
on
the
upwind
side,
immediately
prior
to
application.

(
3)
For
all
crops
other
than
cotton:
make
aerial
or
ground
applications
when
the
wind
velocity
is
3
to
10
mph.
Do
not
apply
when
the
wind
speed
is
greater
than
10
mph.
For
all
non­
aerial
applications,
wind
speed
must
be
measured
adjacent
to
the
application
site
on
the
upwind
side,

immediately
prior
to
application.
Directions
for
Use
Page
64
of
79
(
4)
Do
not
make
aerial
or
ground
applications
into
temperature
inversions.

(
5)
For
ground
boom
applications,
apply
with
nozzle
height
no
more
than
4
feet
above
the
ground
or
crop
canopy.

(
6)
For
airblast
applications,
turn
off
outward
pointing
nozzles
at
row
ends
and
when
spraying
the
outer
two
rows.
To
minimize
spray
loss
over
the
top
in
orchard
applications,
spray
must
be
directed
into
the
canopy.

(
7)
For
ground­
boom,
chemigation,
or
airblast
applications,
do
not
apply
within
25
feet
of
water
bodies
or
aquatic
habitat
(
such
as
lakes,

reservoirs,
rivers,
streams,
marshes,
ponds,
estuaries,
and
commercial
fish
ponds).

(
8)
For
aerial
application,
do
not
apply
within
150
feet
of
water
bodies
or
aquatic
habitat
(
such
as
lakes,
reservoirs,
rivers,
streams,
marshes,
ponds,

estuaries,
and
commercial
fish
ponds).
Increase
the
no
spray
buffer
zone
to
450
feet
when
making
an
ultra
low
volume
(
ULV)
application.

(
9)
For
aerial
applications,
do
not
release
spray
at
a
height
greater
than
10
feet
above
the
ground
or
crop
canopy
when
spraying
within
1000
feet
of
water
bodies
or
aquatic
habitat.

(
10)
For
aerial
applications,
the
outermost
nozzles
must
not
exceed
60%

of
the
wingspan
or
80%
of
the
rotor
blade
diameter.

(
11)
When
aerial
applications
are
made
with
a
cross­
wind,
the
swath
will
be
displaced
downwind.
The
applicator
must
compensate
for
this
displacement
at
the
downwind
edge
of
the
application
area
by
adjusting
the
path
of
the
aircraft
upwind."

End
Use
Products
Primarily
Intended
for
Occupational
Use
(
Non­
Agricultural)
Page
65
of
79
PPE
Requirements
Established
by
the
RED1
For
Wettable
Powder
Products
(
only
wettable
powder
formulations
packaged
in
water
soluble
bags
will
be
eligible
for
reregistration).
"
Personal
Protective
Equipment
(
PPE)

Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemical­
resistant
material).
If
you
want
more
options,

follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators,
and
other
handlers
must
wear:

>
Long­
sleeve
shirt
and
long
pants,

>
Shoes
plus
socks,

>
Chemical
resistant
gloves."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED1
For
Emulsifiable
Concentrate,
Dry
Flowable
and
Granular
Products
"
Personal
Protective
Equipment
(
PPE)

Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemical­
resistant
material).
If
you
want
more
options,

follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators,
and
other
handlers
must
wear:

>
Long­
sleeve
shirt
and
long
pants,

>
Shoes
plus
socks,

>
Chemical
resistant
gloves."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED1
For
Ready­
To­
Use
Products
(
total
release
foggers,
aerosols,

pump
sprays,
wipes,

ear
tags)
"
Personal
Protective
Equipment
(
PPE)

Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemical­
resistant
material).
A
If
you
want
more
options,

follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators,
and
other
handlers
must
wear:

>
Long­
sleeve
shirt
and
long
pants,

>
Shoes
plus
socks."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
User
Safety
"
Follow
manufacturer's
instructions
for
cleaning/
maintaining
PPE.
If
no
such
instructions
for
washables
exist,
use
detergent
and
hot
water.
Keep
Immediately
following
the
PPE
requirements
Page
66
of
79
Requirements
and
wash
PPE
separately
from
other
laundry.

Discard
clothing
and
other
absorbent
materials
that
have
been
drenched
or
heavily
contaminated
with
this
product's
concentrate.
Do
not
reuse
them."

Environmental
Hazard
Statements
For
products
that
have
outdoor
uses:

"
This
product
is
extremely
toxic
to
fish.
Do
not
apply
directly
to
or
near
water.
Drift
and
run­
off
may
be
hazardous
to
fish
in
water
adjacent
to
treated
areas.
Do
not
contaminate
water
when
disposing
of
equipment,

washwater,
or
rinsate.
See
Directions
for
Use
for
additional
precautions
and
requirements."

[
CHECK
THIS
­
­
ADD:
"
AND
OTHER
AQUATIC
ORGANISMS"?]

Entry
Restrictions
for
Products
Applied
as
a
Spray
"
Do
not
allow
children
or
pets
to
contact
treated
surfaces
until
sprays
have
dried."
Directions
for
Use
Under
General
Precautions
and
Restrictions.

Entry
Restrictions
for
Total
Release
Fogger
Products
[
INSERT
VENTILATION
REQUIREMENTS
HERE?]

Hazards
to
Humans
and
Domestic
Animals
[
THERE
ARE
A
NUMBER
OF
STATEMENTS
ALREADY
ON
LABELS
(
SEE
P.
2
OF
11715­
355,
FOR
EXAMPLE.]

"
Prolonged
or
frequently
repeated
skin
contact
may
cause
allergic
reactions
in
some
individuals.
Remove
contaminated
clothing
and
wash
before
reuse.
Wash
thoroughly
with
soap
and
water
after
handling."

General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
people
or
pets,

either
directly
or
through
drift."
Directions
for
Use
Under
General
Precautions
and
Restrictions.

Application
Restrictions
For
nuisance
pest
control
products
(
other
than
termiticides)

Products
(
all
formulations)
must
be
amended
to
reflect
the
following
maximum
application
rate
(
ai/
A):
Directions
for
Use
Under
General
Precautions
and
Restrictions.
Page
67
of
79
Residential,
commercial,
and
industrial
lawns:
Maximum
application
rate
of
0.44
lbs
ai/
A
(
0.0101
lbs
ai/
1000
ft2).

"
Limit
all
outdoor
applications
to
spot
and
crack­
and­
crevice
applications,
only,
except
for
the
following
barrier,
perimeter,
band
or
broadcast
spray
applications,
which
are
permitted:

 
Barrier,
perimeter
or
band
applications
to
soil
or
vegetation
around
structures;

 
Broadcast
applications
to
vegetated
residential
or
commercial
landscapes,
including
lawns
and
turf;

 
Band
applications
to
building
foundations,
up
to
a
maximum
height
of
3
feet.

Other
than
number
(
3),
above,
all
outdoor
applications
to
impervious
surfaces
such
as
sidewalks,
driveways,
patios,
porches
and
structural
surfaces
(
such
as
windows,
doors,
and
eaves)
are
limited
to
spot
and
crack­
and­
crevice
applications,
only."

Application
to
swimming
pool
water
systems,
or
to
swimming
pools
in
general,
is
not
a
labeled
use
of
cypermethrin.
Cypermethrin
may
be
applied
as
a
broadcast
treatment
to
lawns
and
other
vegetated
areas
around
swimming
pools,
or
as
a
spot
or
crack­
and­
crevice
treatment
to
impermeable
surfaces
(
such
as
tiled
walkways)
around
pools.

"
Do
not
apply
directly
into
drains,
or
to
any
area
where
drainage
to
storm
sewers,
water
bodies,
or
aquatic
habitat
can
occur.
When
making
an
application
around
or
near
a
floor
drain,
limit
the
application
to
a
spot
treatment
and
do
not
allow
the
product
to
enter
the
drain
during
or
after
the
application."
The
use
site
"
Application
around
or
near
floor
drains"

must
be
listed
separately
from
other
indoor
use
sites
on
the
label,
with
these
restrictions.

"
For
outdoor
uses,
do
not
apply
within
10
feet
of
storm
drains.
Do
not
apply
within
25
feet
of
rivers,
fish
ponds,
lakes,
streams,
reservoirs,

marshes,
estuaries,
bays,
and
oceans."

"
Broadcast
applications
to
exterior
surfaces
of
boats
are
prohibited.
Page
68
of
79
Applications
to
exterior
surfaces
of
boats
are
limited
to
spot
treatments,

only.
Use
inside
boats,
ships,
and
other
vessels
is
permitted.
Do
not
allow
product
to
drain
or
wash
off
into
water
bodies
or
aquatic
habitat."
The
use
site
"
Application
in
and
on
boats"
must
be
listed
separately
from
other
use
sites
on
the
label,
with
these
restrictions.

"
Do
not
apply
when
windy
(
sustained
wind
speeds
or
gusts
above
10
mph)."

"
After
application,
do
not
over­
water
the
treated
area
to
the
point
of
runoff.
Do
not
apply
when
raining
or
when
rain
is
expected
within
8
hours
of
application."

"
Rinse
application
equipment
over
lawn
or
garden
area
only.
Do
not
allow
rinse
water
to
flow
into
drains
(
including
storm
drains),
street
gutters,
sewers,
drainage
ditches,
water
bodies,
or
aquatic
habitat."

"
Do
not
allow
applications
to
contact
water
inhabited
by
fish,
such
as
aquariums
and
ornamental
fish
ponds
that
are
located
in/
near
structures
being
treated.
Cover
any
water
inhabited
by
fish
during
treatment,
and
turn
aquarium
systems
off."

STATEMENTS
CURRENTLY
ON
SOME
PRODUCT
LABELS
(
SHOULD
BE
MAINTAINED
AND
ADDED
TO
ALL
APPROPRIATE
PRODUCTS):

"
Do
not
use
water­
based
sprays
in
conduits,
motor
housings,
junction
boxes,
switch
boxes,
or
other
electrical
equipment
because
of
possible
shock
hazard."

"
Do
not
apply
to
pets."
[
NOTE:
DO
WE
NEED
AN
ADDITIONAL
WARNING
ABOUT
HIGH
TOXICITY
TO
CATS?]

"
Do
not
use
as
a
space
spray."

"
Use
only
in
well­
ventilated
areas."
Page
69
of
79
"
During
any
indoor
surface
application,
do
not
allow
dripping
or
runoff
to
occur.
During
any
application
to
ceilings
of
a
structure,
cover
surface
below
with
plastic
shielding
or
similar
material."

"
Do
not
apply
this
product
in
any
room
being
used
as
a
living,
eating,
or
recovery
area
by
patients,
the
elderly,
or
infirm
when
they
are
in
the
room."

"
Do
not
apply
to
classrooms
when
in
use."

"
Do
not
apply
to
areas
of
institutions
(
including
libraries,
sport
facilities,

etc.)
when
occupants
are
present
in
the
immediate
treatment
area."

"
Not
labeled
for
use
in
food
areas.
Do
not
use
in
food
areas
of
food
handling
establishments,
restaurants,
or
other
areas
where
food
is
commercially
prepared
or
processed.
Do
not
use
in
serving
areas
while
food
is
exposed
or
facility
is
in
operation.
Serving
areas
are
areas
where
prepared
foods
are
served,
such
as
dining
rooms,
but
excluding
areas
where
foods
may
be
prepared
or
held.
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."

"
Do
not
use
in
warehouses
where
raw
or
cured
tobacco
is
stored."

"
Do
not
use
in
warehouses
while
raw
agricultural
commodities
for
food
or
feed
are
being
stored."

"
Do
not
use
in
greenhouses
where
crops
for
food
or
feed
are
grown."

"
Do
not
apply
to
aircraft
cabins."

"
Do
not
use
concentrate
or
emulsion
in
fogging
equipment."

For
subterranean
termite
control
Page
70
of
79
Maintain,
modify,
or
add
the
following
statements
to
product
labels:

[
SHOULD
WE
ADD
ANY
OTHER
STATEMENTS
FROM
THE
SYNGENTA
LABEL,
BELOW?]:

"
Use
anti­
backflow
equipment
or
procedures
to
prevent
siphonage
of
pesticide
back
into
water
supplies."

"
Do
not
treat
soil
beneath
structures
that
contain
wells
or
cisterns."

"
Care
should
be
taken
that
the
treatment
solution
is
not
introduced
into
the
gravel
and/
or
pipe
drainage
system
which
may
be
located
on
the
exterior
of
the
foundation
in
close
proximity
to
the
footing
of
the
structure."

"
Care
must
be
taken
to
avoid
runoff.
Do
not
treat
soil
that
is
watersaturated
or
frozen.
Do
not
treat
when
raining
or
when
rain
is
expected
within
8
hours."

"
Consult
state
and
local
specifications
for
recommended
distance
of
treatment
areas
from
wells.
Refer
to
Federal
Housing
Administration
Specifications
for
guidance
on
preconstruction
treatments."

For
pre­
construction
subterranean
termite
control
"
If
concrete
slabs
cannot
be
poured
over
the
treated
soil
on
the
day
of
application,
the
treated
soil
must
be
covered
with
a
waterproof
covering
(
such
as
polyethylene
sheeting)."

"
Do
not
treat
soil
that
is
water­
saturated
or
frozen.
Do
not
treat
when
raining
or
when
rain
is
expected
within
8
hours.
All
treated
areas
must
covered
(
with
a
waterproof
covering)
before
it
starts
to
rain.
Storm
water
runoff
must
be
diverted
around
the
treatment
area
to
prevent
water
from
contacting
or
collecting
in
the
treatment
area."

"
Do
not
apply
within
10
feet
of
storm
drains.
Do
not
apply
within
25
feet
of
rivers,
fish
ponds,
lakes,
streams,
reservoirs,
marshes,
estuaries,
bays,
Page
71
of
79
or
oceans."

"
Do
not
make
on­
grade
applications
when
sustained
wind
speeds
or
gusts
are
above
10
mph."

"
Whenever
possible,
make
termite
control
applications
near
the
structure
foundation
using
soil
injection."

For
all
termiticide
products
"
All
leaks
resulting
in
the
deposition
of
termiticide
in
locations
other
than
those
prescribed
on
this
label
must
be
cleaned
up
prior
to
leaving
the
application
site.
Do
not
allow
people
or
pets
to
contact
contaminated
areas
or
to
reoccupy
the
contaminated
area
of
the
structure
until
the
clean
up
is
completed."
[
THIS
STATEMENT
IS
ON
A
CURRENT
SYNGENTA
PRODUCT]

[
Other
statements
on
current
Syngenta
termiticide
label:

"
Structures
with
adjacent
well/
cisterns
and/
or
other
water
bodies."

"
Applicators
must
inspect
all
structures
with
nearby
water
sources
such
as
wells,
cisterns,
surface
ponds,
streams,
and
other
bodies
of
water
and
evaluate,
at
a
minimum,
the
treatment
recommendations
listed
below
prior
to
making
an
application.

1.
Prior
to
treatment,
if
feasible,
expose
the
water
pipe(
s)

coming
from
the
well
to
the
structure,
if
the
pipe(
s)
enter
the
structure
within
3
ft.
of
the
grade.

2.
Prior
to
treatment,
applicators
are
advised
to
take
precautions
to
limit
the
risk
of
applying
the
termiticide
into
subsurface
drains
that
could
empty
into
any
bodies
of
water.
These
precautions
include
evaluating
whether
application
of
the
termiticide
to
the
top
of
the
footer
may
result
in
contamination
of
the
subsurface
drain.
Factors
such
as
depth
to
the
drain
system
and
soil
type
and
degree
of
compaction
should
be
taken
into
account
in
determining
the
depth
of
treatment.
Page
72
of
79
3.
When
appropriate
(
i.
e.,
on
the
water
side
of
the
structure),
the
treated
backfill
technique
(
described
above)
can
also
be
used
to
minimize
off­
site
movement
of
the
termiticide."]

End
Use
Products
Primarily
Intended
for
Residential
Use
Environmental
Hazard
Statements
For
products
that
have
outdoor
uses:

"
This
product
is
extremely
toxic
to
fish.
Do
not
apply
directly
to
or
near
water.
Drift
and
run­
off
may
be
hazardous
to
fish
in
water
adjacent
to
treated
areas.
Do
not
contaminate
water
when
disposing
of
equipment,

washwater,
or
rinsate.
See
Directions
for
Use
for
additional
precautions
and
requirements."

[
CHECK
THIS
­
­
ADD:
"
AND
OTHER
AQUATIC
ORGANISMS"?]

Entry
Restrictions
for
products
applied
as
a
spray
"
Do
not
allow
children
or
pets
to
contact
treated
surfaces
until
sprays
have
dried."
Directions
for
use
under
General
Precautions
and
Restrictions
Entry
Restrictions
for
Total
Release
Fogger
Products
[
INSERT
VENTILATION
REQUIREMENTS
HERE?]

Hazards
to
Humans
and
Domestic
Animals
[
THERE
ARE
A
NUMBER
OF
STATEMENTS
ALREADY
ON
LABELS
(
SEE
P.
2
OF
11715­
355,
FOR
EXAMPLE.]

"
Prolonged
or
frequently
repeated
skin
contact
may
cause
allergic
reactions
in
some
individuals.
Remove
contaminated
clothing
and
wash
before
reuse.
Wash
thoroughly
with
soap
and
water
after
handling."

General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
any
person,
pet,

either
directly
or
through
drift.
Keep
people
and
pets
out
of
the
area
during
application."
Directions
for
Use
under
General
Precautions
and
Restrictions
Page
73
of
79
Additional
Application
Restrictions
[
ARE
ANY
OF
THESE
STATEMENTS
NOT
APPROPRIATE
FOR
A
HOMEOWNER
LABEL?]

Products
(
all
formulations)
must
be
amended
to
reflect
the
following
maximum
application
rate
(
ai/
A):

Residential
lawns:
Maximum
application
rate
of
0.44
lbs
ai/
A
(
0.0101
lbs
ai/
1000
ft2).

"
Limit
all
outdoor
applications
to
spot
and
crack­
and­
crevice
applications,
only,
except
for
the
following
barrier,
perimeter,
band
or
broadcast
spray
applications,
which
are
permitted:

 
Barrier,
perimeter
or
band
applications
to
soil
or
vegetation
around
structures;

 
Broadcast
applications
to
vegetated
residential
or
commercial
landscapes,
including
lawns
and
turf;

 
Band
applications
to
building
foundations,
up
to
a
maximum
height
of
3
feet.

Other
than
number
(
3),
above,
all
outdoor
applications
to
impervious
surfaces
such
as
sidewalks,
driveways,
patios,
porches
and
structural
surfaces
(
such
as
windows,
doors,
and
eaves)
are
limited
to
spot
and
crack­
and­
crevice
applications,
only."

Application
to
swimming
pool
water
systems,
or
to
swimming
pools
in
general,
is
not
a
labeled
use
of
cypermethrin
and
must
be
removed
from
product
labels.
Cypermethrin
may
be
applied
as
a
broadcast
treatment
to
lawns
and
other
vegetated
areas
around
swimming
pools,
or
as
a
spot
or
crack­
and­
crevice
treatment
to
impermeable
surfaces
(
such
as
tiled
walkways)
around
pools.

"
Do
not
apply
directly
into
drains,
or
to
any
area
where
drainage
to
storm
sewers,
water
bodies,
or
aquatic
habitat
can
occur.
When
making
an
application
around
or
near
a
floor
drain,
limit
the
application
to
a
spot
treatment
and
do
not
allow
the
product
to
enter
the
drain
during
or
after
the
application."
The
use
site
"
Application
around
or
near
floor
drains"
Directions
for
Use
under
General
Precautions
and
Restrictions
Page
74
of
79
must
be
listed
separately
from
other
indoor
use
sites
on
the
label,
with
these
restrictions.

"
For
outdoor
uses,
do
not
apply
within
10
feet
of
storm
drains.
Do
not
apply
within
25
feet
of
rivers,
fish
ponds,
lakes,
streams,
reservoirs,

marshes,
estuaries,
bays,
and
oceans."

"
Broadcast
applications
to
exterior
surfaces
of
boats
are
prohibited.

Applications
to
exterior
surfaces
of
boats
are
limited
to
spot
treatments,

only.
Use
inside
boats,
ships,
and
other
vessels
is
permitted.
Do
not
allow
product
to
drain
or
wash
off
into
water
bodies
or
aquatic
habitat."
The
use
site
"
Application
in
and
on
boats"
must
be
listed
separately
from
other
use
sites
on
the
label,
with
these
restrictions.

"
Do
not
apply
when
windy
(
sustained
wind
speeds
or
gusts
above
10
mph)."

"
After
application,
do
not
over­
water
the
treated
area
to
the
point
of
runoff.
Do
not
apply
when
raining
or
when
rain
is
expected
within
8
hours
of
application."

"
Rinse
application
equipment
over
lawn
or
garden
area
only.
Do
not
allow
rinse
water
to
flow
into
drains
(
including
storm
drains),
street
gutters,
sewers,
drainage
ditches,
water
bodies,
or
aquatic
habitat."

"
Do
not
allow
applications
to
contact
water
inhabited
by
fish,
such
as
aquariums
and
ornamental
fish
ponds
that
are
located
in/
near
structures
being
treated.
Cover
any
water
inhabited
by
fish
during
treatment,
and
turn
aquarium
systems
off."

STATEMENTS
CURRENTLY
ON
SOME
PRODUCT
LABELS
(
SHOULD
BE
MAINTAINED
AND
ADDED
TO
ALL
APPROPRIATE
PRODUCTS):

"
Do
not
use
water­
based
sprays
in
conduits,
motor
housings,
junction
boxes,
switch
boxes,
or
other
electrical
equipment
because
of
possible
shock
hazard."
Page
75
of
79
"
Do
not
apply
to
pets."
[
NOTE:
DO
WE
NEED
AN
ADDITIONAL
WARNING
ABOUT
HIGH
TOXICITY
TO
CATS?]

"
Do
not
use
as
a
space
spray."

"
Use
only
in
well­
ventilated
areas."

"
During
any
indoor
surface
application,
do
not
allow
dripping
or
runoff
to
occur.
During
any
application
to
ceilings
of
a
structure,
cover
surface
below
with
plastic
shielding
or
similar
material."

"
Do
not
apply
this
product
in
any
room
being
used
as
a
living,
eating,
or
recovery
area
by
patients,
the
elderly,
or
infirm
when
they
are
in
the
room."

"
Do
not
apply
to
classrooms
when
in
use."

"
Do
not
apply
to
areas
of
institutions
(
including
libraries,
sport
facilities,

etc.)
when
occupants
are
present
in
the
immediate
treatment
area."

"
Not
labeled
for
use
in
food
areas.
Do
not
use
in
food
areas
of
food
handling
establishments,
restaurants,
or
other
areas
where
food
is
commercially
prepared
or
processed.
Do
not
use
in
serving
areas
while
food
is
exposed
or
facility
is
in
operation.
Serving
areas
are
areas
where
prepared
foods
are
served,
such
as
dining
rooms,
but
excluding
areas
where
foods
may
be
prepared
or
held.
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."

"
Do
not
use
in
greenhouses
where
crops
for
food
or
feed
are
grown."

"
Do
not
use
concentrate
or
emulsion
in
fogging
equipment."
Page
76
of
79
1
PPE
that
is
established
on
the
basis
of
Acute
Toxicity
of
the
end­
use
product
must
be
compared
to
the
active
ingredient
PPE
in
this
document.

The
more
protective
PPE
must
be
placed
in
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93­
7.

2
If
the
product
contains
oil
or
bears
instructions
that
will
allow
application
with
an
oil­
containing
material,
the
A
N
@
designation
must
be
dropped.
Page
77
of
79
Appendix
A.
Uses
of
Cypermethrin
Eligible
for
Reregistration
Crop
Typical
Application
Rate
(
lbs
ai/
acre)
Maximum/
Rescue
Application
Rate(
lbs
ai/
acre)
Maximum
Total
Pounds
A.
I.
Applied
Per
Acre
Per
Year
MaximumNum
ber
of
Applications
Minimum
Retreatment
Interval
Application
Method
REI
Pre
Harvest
Interval
(
PHI)

Appendix
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
To
be
added.
Page
78
of
79
Appendix
C.
Technical
Support
Documents
To
be
added
Page
79
of
79
Appendix
D.
Citations
Considered
to
be
Part
of
the
Data
Base
Supporting
the
Reregistration
Eligibility
Decision
MRID
Citation
00034562
00035127
00058170
00089415
Accession
Number
Citation
130888
Howard,
D.
J.
and
C.
D.
Johnston.
1971.
CYTOX
2160
­
Safety
Evaluation
by
Single
Oral
Administration
to
Bobwhite
Quail.
Unpublished
Study
Conducted
by
Woodard
Research
Corporation
for
American
Cyanamid
Co.

131455
Johnston,
C.
D.
1971.
CYTOX
2160
­
Safety
Evaluation
by
Single
Oral
Administration
to
Mallard
Ducks.
Unpublished
Study
Conducted
by
Woodard
Research
Corporation
for
American
Cyanamid
Co.

132149
Sleight,
Bevier
Hasbrouck.
1971.
The
Acute
Toxicity
of
CYTOX
2160
(
ST
45093)
to
Bluegill
(
Lepomis
macrochirus)
and
Rainbow
Trout
(
Onchirynchus
mykiss
formerly
Salmo
gairdneri).
Unpublished
Study
Conducted
by
Bionomics,

Inc.
for
American
Cyanamid
Co.

226855
Fink,
R.
1976.
Eight­
Day
Dietary
LC50
­
Bobwhite
quail
­
CYTOX
2160.

Unpublished
Study
Conducted
by
Wildlife
International
for
Union
Carbide
Corp.

Submitted
by
American
Cyanamid
Company.