1
United
States
Prevention,
Pesticides
EPA
738­
R­
06­
003
Environmental
Protection
and
Toxic
Substances
June
2006
Agency
(
7508C)

Reregistration
Eligibility
Decision
for
Resmethrin
2
REREGISTRATION
ELIGIBILITY
DECISION
for
Resmethrin
List
A
Case
No.
0421
Approved
by:

______________________
Debra
Edwards,
Ph.
D.
Director,
Special
Review
and
Reregistration
Division
________________________
Date
3
Table
of
Contents
Executive
Summary
......................................................................................................
8
I.
Introduction
............................................................................................................
15
I.
Introduction
............................................................................................................
15
II.
Chemical
Overview................................................................................................
16
A.
Regulatory
History
............................................................................................
16
B.
Chemical
Identification
...................................................................................
17
C.
Resmethrin
Use
Profile....................................................................................
17
III.
Summary
of
Resmethrin
Risk
Assessments........................................................
19
A.
Human
Health
Risk
Assessment
.......................................................................
19
1.
Toxicity............................................................................................................
19
2.
Dietary
Risk
(
Food
+
Water)..........................................................................
24
3.
Acute
Dietary
Risk..........................................................................................
24
4.
Drinking
Water
Dietary
Exposure
and
Risk
.................................................
24
5.
Chronic
Non­
Cancer
Dietary
Risk
(
Food
+
Water)
......................................
25
6.
Cancer
Dietary
Risk
(
Food
+
Water).............................................................
27
7.
Residential
Risk
..............................................................................................
27
8.
Residential
Handler
Risk................................................................................
29
9.
Residential
Post­
application
Risk
..................................................................
30
10.
Aggregate
Risk..............................................................................................
32
11.
Cumulative
Risk
...........................................................................................
34
12.
Occupational
Risk.........................................................................................
34
a.
Occupational
Non­
cancer
Handler
Summary
...........................................
36
b.
Occupational
Cancer
Handler
Summary
..................................................
36
c.
Postapplication
Occupational
Risk
............................................................
38
13.
Human
Incident
Data
...................................................................................
38
B.
Environmental
Risk
Assessment
.......................................................................
38
1.
Environmental
Fate
and
Transport
...............................................................
39
2.
Ecological
Risk................................................................................................
39
a.
Risk
to
Aquatic
Organisms.........................................................................
40
b.
Risk
to
Terrestrial
Organisms
...................................................................
45
3.
Ecological
Incidents
........................................................................................
49
4.
Endangered
Species
Concerns
.......................................................................
49
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision.......
51
A.
Determination
of
Reregistration
Eligibility
and
Tolerance
Reassessment
......
51
B.
Regulatory
Position............................................................................................
51
1.
Food
Quality
Protection
Act
Findings
...........................................................
51
2.
Endocrine
Disruptor
Effects
..........................................................................
52
3.
Cumulative
Risks............................................................................................
53
C.
Tolerance
Reassessment
Summary...................................................................
53
D.
Regulatory
Rationale.........................................................................................
54
1.
Human
Health
Risk........................................................................................
54
2.
Environmental
Risk........................................................................................
56
3.
Ongoing
Work
on
Pyrethoids.........................................................................
61
4
V.
What
Registrants
Need
to
Do..............................................................................
66
A.
Manufacturing
Use
Products
.............................................................................
66
1.
Additional
Generic
Data
Requirements..........................................................
66
B.
End­
Use
Products
............................................................................................
67
1.
Additional
Product­
Specific
Data
Requirements
.......................................
67
2.
Labeling
for
End­
Use
Products
...................................................................
67
Appendix
A..................................................................................................................
81
Appendix
B..................................................................................................................
83
Appendix
C..................................................................................................................
93
Appendix
D..................................................................................................................
95
5
Resmethrin
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs
Biological
and
Economic
Analysis
Assessment
Alan
Halvorson
Steve
Jarboe
Timothy
Kiely
Andrew
Lee
Nikhil
Mallampalli
Environmental
Fate
and
Effects
Risk
Assessment
Michael
Hoffman
Jean
Holmes
José
Melendez
Mah
Shamim
Health
Effects
Risk
Assessment
Rebecca
Daiss
William
Dykstra
Susan
Hummel
David
Jaquith
Ray
Kent
Thurston
Morton
Registration
Support
Richard
Gebken
Marion
Johnson
Mark
Suarez
Joseph
Tavano
Risk
Management
Katie
Hall
Dirk
Helder
Susan
Jennings
Margaret
Rice
Office
of
General
Counsel
Erin
Koch
United
States
Department
of
Agriculture
Teung
Chin
6
Glossary
of
Terms
and
Abbreviations
a.
i.
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
APHIS
Animal
and
Plant
Health
Inspection
Service
ARTF
Agricultural
Re­
entry
Task
Force
BCF
Bioconcentration
Factor
CDC
Centers
for
Disease
Control
CDPR
California
Department
of
Pesticide
Regulation
CFR
Code
of
Federal
Regulations
ChEI
Cholinesterase
Inhibition
CMBS
Carbamate
Market
Basket
Survey
cPAD
Chronic
Population
Adjusted
Dose
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
CWS
Community
Water
System
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DL
Double
layer
clothing
{
i.
e.,
coveralls
over
SL}
DWLOC
Drinking
Water
Level
of
Comparison
EC
Emulsifiable
Concentrate
Formulation
EDSP
Endocrine
Disruptor
Screening
Program
EDSTAC
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
EEC
Estimated
Environmental
Concentration.
The
estimated
pesticide
concentration
in
an
environment,
such
as
a
terrestrial
ecosystem.
EP
End­
Use
Product
EPA
U.
S.
Environmental
Protection
Agency
EXAMS
Tier
II
Surface
Water
Computer
Model
FDA
Food
and
Drug
Administration
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FOB
Functional
Observation
Battery
FQPA
Food
Quality
Protection
Act
FR
Federal
Register
GL
With
gloves
GPS
Global
Positioning
System
HIARC
Hazard
Identification
Assessment
Review
Committee
IDFS
Incident
Data
System
IGR
Insect
Growth
Regulator
IPM
Integrated
Pest
Management
RED
Reregistration
Eligibility
Decision
LADD
Lifetime
Average
Daily
Dose
LC50
Median
Lethal
Concentration.
Statistically
derived
concentration
of
a
substance
expected
to
cause
death
in
50%
of
test
animals,
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LCO
Lawn
Care
Operator
LD50
Median
Lethal
Dose.
Statistically
derived
single
dose
causing
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation),
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOAEC
Lowest
Observed
Adverse
Effect
Concentration
LOAEL
Lowest
Observed
Adverse
Effect
Level
LOC
Level
of
Concern
LOEC
Lowest
Observed
Effect
Concentration
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
MOE
Margin
of
Exposure
MP
Manufacturing­
Use
Product
7
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MRL
Maximum
Residue
Level
N/
A
Not
Applicable
NASS
National
Agricultural
Statistical
Service
NAWQA
USGS
National
Water
Quality
Assessment
NG
No
Gloves
NMFS
National
Marine
Fisheries
Service
NOAEC
No
Observed
Adverse
Effect
Concentration
NOAEL
No
Observed
Adverse
Effect
Level
NPIC
National
Pesticide
Information
Center
NR
No
respirator
OP
Organophosphorus
OPP
EPA
Office
of
Pesticide
Programs
ORETF
Outdoor
Residential
Exposure
Task
Force
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDCI
Product
Specific
Data
Call­
In
PDP
USDA
Pesticide
Data
Program
PF10
Protections
factor
10
respirator
PF5
Protection
factor
5
respirator
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
PRZM
Pesticide
Root
Zone
Model
RBC
Red
Blood
Cell
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RPA
Reasonable
and
Prudent
Alternatives
RPM
Reasonable
and
Prudent
Measures
RQ
Risk
Quotient
RTU
(
Ready­
to­
use)
RUP
Restricted
Use
Pesticide
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SF
Safety
Factor
SL
Single
layer
clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
STORET
Storage
and
Retrieval
TEP
Typical
End­
Use
Product
TGAI
Technical
Grade
Active
Ingredient
TRAC
Tolerance
Reassessment
Advisory
Committee
TTRS
Transferable
Turf
Residues
UF
Uncertainty
Factor
USDA
United
States
Department
of
Agriculture
USFWS
United
States
Fish
and
Wildlife
Service
USGS
United
States
Geological
Survey
WPS
Worker
Protection
Standard
8
Executive
Summary
The
Environmental
Protection
Agency
(
EPA
or
the
Agency)
has
completed
the
human
health
and
environmental
risk
assessments
for
resmethrin
and
is
issuing
its
risk
management
decision
and
tolerance
reassessment.
There
is
currently
one
tolerance
being
reassessed
for
resmethrin
for
use
as
an
insecticide
in
food
handling
establishments
and
storage
areas.
The
revised
risk
assessments
are
based
on
the
Agency's
review
of
the
required
data
supporting
the
use
patterns
of
currently
registered
resmethrin
products
and
additional
information
and
comments
received.
After
considering
the
risks
identified
in
the
revised
risk
assessment,
public
comments,
and
mitigation
suggestions
from
interested
parties,
EPA
developed
its
risk
management
decision
for
uses
of
resmethrin
that
pose
risks
of
concern.
As
a
result,
the
Agency
has
determined
that
resmethrin­
containing
products
are
eligible
for
reregistration
provided
that
the
risk
mitigation
measures
outlined
in
this
document
are
adopted
and
labels
are
amended
accordingly.
The
eligibility
decision
is
discussed
fully
in
this
document.

Resmethrin
is
a
member
of
the
pyrethroid
class
of
pesticides
and
was
first
registered
in
1967.
It
is
a
broad
spectrum,
non­
systemic,
synthetic
pyrethroid
insecticide.
Resmethrin
is
registered
for
use
as
a
wide
area
mosquito
abatement
insecticide,
for
use
in
livestock
and
livestock
housing,
food
item
transportation,
structures,
buildings
(
including
food
handling
establishments),
and
for
residential
use
to
control
flying
and
crawling
insects.
Approximately
50,000
pounds
of
resmethrin
are
used
annually,
mostly
for
adult
mosquito
control.
Resmethrin
is
currently
classified
as
a
Restricted
Use
Pesticide
for
wide
area
mosquito
abatement.

Resmethrin
is
a
member
of
the
pyrethroid
class
of
pesticides.
Although
all
pyrethroids
alter
nerve
function
by
modifying
the
normal
biochemistry
and
physiology
of
nerve
membrane
sodium
channels,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids
because
there
are
multiple
types
of
sodium
channels,
and
it
is
currently
unknown
whether
all
pyrethroids
have
similar
effects
on
all
channels.
In
addition,
the
Agency
does
not
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function,
e.
g.,
nerve
excitability,
nor
do
we
understand
how
these
key
events
interact
to
produce
their
compound­
specific
patterns
of
neurotoxicity.
There
is
ongoing
research
by
both
EPA's
Office
of
Research
and
Development
and
the
pyrethroid
registrants
to
evaluate
the
differential
biochemical
and
physiological
actions
of
pyrethroids
in
mammals.
This
research
is
expected
to
be
completed
by
2007.
When
the
results
of
this
research
are
available,
the
Agency
will
make
a
determination
of
common
mechanism
of
toxicity
as
a
basis
for
assessing
cumulative
risk.
For
information
regarding
EPA's
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
of
toxicity,
see
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

Overall
Risk
Summary
The
resmethrin
human
health
risk
assessment
indicates
low
acute
toxicity
and
no
acute
dietary
endpoint
was
identified
in
the
studies
reviewed
by
the
Agency.
The
chronic
(
non­
cancer
and
cancer)
dietary
risks
from
food
and
drinking
water
sources
are
below
the
9
Agency's
level
of
concern.
Residential
handler
(
non­
cancer
and
cancer)
risks
are
below
the
Agency's
level
of
concern.
One
residential
post­
application
exposure
scenario
slightly
exceeds
the
Agency's
level
of
concern
(
MOE=
900),
but
this
can
be
mitigated
with
label
language
to
reduce
exposure.

All
risk
concerns
for
occupational
handlers
that
mix,
load,
and/
or
apply
resmethrin
can
be
mitigated
with
personal
protective
equipment
(
PPE).

Resmethrin
poses
acute
risk
to
some
aquatic
species,
with
the
most
vulnerable
species
being
freshwater
and
estuarine/
marine
invertebrates.
Terrestrial
animals
exposed
to
resmethrin
are
below
the
Agency's
level
of
concern;
however,
resmethrin
does
pose
an
acute
risk
to
non­
target
insects
such
as
honeybees.

Dietary
Risk
No
acute
dietary
analysis
was
conducted
for
resmethrin
because
no
acute
oral
endpoint
of
concern
attributable
to
a
single
exposure
was
established
in
dietary
studies
reviewed
by
the
Agency.
Chronic
(
non­
cancer)
dietary
risk
from
resmethrin
is
low
and
below
the
Agency's
level
of
concern.
The
chronic
dietary
assessment
indicates
no
risks
of
concern
for
the
general
population
or
any
sub­
population.
Risk
estimates
are
2%
of
the
cPAD
for
the
general
population
and
7%
of
the
cPAD
for
children
1­
2
years
old,
the
most
highly
exposed
population
sub­
group.
The
drinking
water
exposure
assessment
for
resmethrin
from
both
ground
and
surface
water
sources
is
also
below
the
Agency's
level
of
concern.

Cancer
dietary
risk
is
below
EPA's
level
of
concern,
as
estimated
lifetime
cancer
risk
for
the
general
U.
S.
population
is
conservatively
estimated
at
1.6
x10­
6.
The
cancer
dietary
assessment
likely
overestimates
exposure
from
registered
uses
of
resmethrin.
The
only
food
use
for
resmethrin
is
in
food
handling
establishments
such
as
food
processing
/
handling
plants,
restaurants,
commercial
food
item
transportation,
and
food
storage
facilities.
The
Agency
conducted
a
conservative
cancer
risk
estimate
assuming
that
10%
of
food
handling
establishments
are
treated
with
resmethrin.
This
is
likely
an
overestimation
of
usage
based
on
use
data
reviewed
by
the
Agency.
Additionally,
for
the
resmethrin
cancer
dietary
assessment,
the
Agency
assumed
that
the
full
limit
of
detection
(
LOD)
level
was
found
for
all
non­
residue
detections
in
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCID).

Resmethrin
degrades
rapidly
when
exposed
to
light
(
photolysis),
however,
when
not
subject
to
photolysis,
resmethrin
tends
to
be
more
environmentally
persistent.
Resmethrin
has
low
mobility
and
has
a
high
affinity
to
bind
to
soils/
sediments
and
organic
carbon;
therefore,
it
is
not
expected
to
leach
to
ground
water.
However,
like
several
other
chemicals
in
its
class,
it
can
reach
surface
waters
by
spray
drift
or
in
run­
off
events
via
erosion.
Nonetheless,
exposure
from
drinking
water
sources
to
resmethrin
is
low.
Acute,
chronic,
and
cancer
dietary
risk
from
food
and
water
are
below
the
Agency's
level
of
concern.
10
Residential
Risk
Resmethrin
has
a
wide
variety
of
residential
uses,
including
use
on
pets,
indoor
and
outdoor
surfaces,
garden
crops,
and
residential
outdoor
mosquito
control.
Resmethrin
is
also
used
in
residential
areas
for
wide
area
mosquito
abatement
programs
by
Public
Health
Officials.

The
Agency
assessed
residential
handler
and
post­
application
exposure
to
resmethrin.
All
residential
handler
non­
cancer
and
cancer
scenarios
are
below
the
Agency's
level
of
concern.

The
post­
application
exposure
assessment
assumed
individuals
of
varying
ages
can
potentially
be
exposed
to
resmethrin
as
a
result
of
being
in
an
area
that
has
been
previously
treated
with
resmethrin
or
have
contact
with
treated
companion
animals.
Most
non­
cancer
risks
from
post­
application
exposure
to
resmethrin
range
from
2400
to
8.5
million
and
are
not
of
concern
to
the
Agency.
However,
the
non­
cancer
risk
estimate
for
a
child
exposed
to
an
indoor
aerosol
space
spray
exceeds
the
Agency's
level
of
concern
(
MOE
=
900).
This
exposure
may
occur
when
a
child
enters
a
room
within
10
minutes
after
a
resmethrin
indoor
aerosol
space
spay
application.
This
risk
can
be
mitigated
with
label
instructions
informing
homeowners
to
keep
all
people
and
pets
out
of
sprayed
rooms
for
2
hours
after
application.
Residential
post­
application
cancer
risk
is
below
the
Agency's
level
of
concern
for
all
assessed
scenarios.

Aggregate
Risk
An
acute
aggregate
assessment
has
not
been
conducted
because
no
appropriate
endpoint
attributable
to
a
single
exposure
was
identified
in
the
resmethrin
database.
In
addition,
the
Agency
did
not
conduct
any
non­
cancer
aggregate
risk
assessment
(
short­,
intermediate­,
or
long­
term)
because
endpoints
selected
for
the
different
routes
of
exposure
are
not
based
on
common
toxic
effects.

The
aggregate
cancer
assessment
combines
lifetime
estimated
dietary
and
residential
risks.
For
resmethrin,
aggregate
dietary
risk
(
food
and
drinking
water)
is
1.6x
10­
6,
and
residential
risk
is
1x
10­
6.
The
resulting
aggregate
risk
estimate
is
2.6x
10­
6,
and
thus
does
not
exceed
the
Agency's
level
of
concern.
Each
component
of
aggregate
exposure
assessment
(
dietary,
drinking
water,
and
residential
risk)
is
based
on
conservative
exposure
scenarios
which
are
greater
than
what
people
are
likely
to
experience.
The
probability
of
people
experiencing
all
these
high­
end
exposures
together
and
for
the
durations
assessed
by
the
Agency
is
unlikely.
Nonetheless,
the
Agency
is
requiring
label
changes
and
clarification
on
all
homeowner
product
labels
that
will
reduce
exposure.

Cumulative
Risk
11
Resmethrin
is
a
member
of
the
pyrethroid
class
of
pesticides.
Although
all
pyrethroids
alter
nerve
function
by
modifying
the
normal
biochemistry
and
physiology
of
nerve
membrane
sodium
channels,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids
because
there
are
multiple
types
of
sodium
channels,
and
it
is
currently
unknown
whether
all
pyrethroids
have
similar
effects
on
all
channels.
In
addition,
the
Agency
does
not
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function,
e.
g.,
nerve
excitability,
nor
do
we
understand
how
these
key
events
interact
to
produce
their
compound­
specific
patterns
of
neurotoxicity.
There
is
ongoing
research
by
both
EPA's
Office
of
Research
and
Development
and
the
pyrethroid
registrants
to
evaluate
the
differential
biochemical
and
physiological
actions
of
pyrethroids
in
mammals.
This
research
is
expected
to
be
completed
by
2007.
When
the
results
of
this
research
are
available,
the
Agency
will
make
a
determination
of
common
mechanism
of
toxicity
as
a
basis
for
assessing
cumulative
risk.
For
information
regarding
EPA's
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
of
toxicity,
see
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

FQPA
Finding
EPA
has
determined
with
reasonable
certainty
that
no
harm
to
the
general
population
or
any
sub­
population
will
result
from
exposure
to
resmethrin.

Occupational
Risk
Occupational
handler
exposures
were
assessed
with
baseline
attire
or
minimal
personal
protective
equipment.
Non­
cancer
exposure
and
risk
estimates
indicate
no
MOEs
of
concern
(
i.
e.,
all
MOEs
are
greater
than
100)
at
the
maximum
use
rate
for
all
occupational
exposure
scenarios
assessed
either
at
baseline
or
with
the
addition
of
chemical­
resistant
gloves.
Cancer
exposure
and
risk
estimates
are
also
below
EPA's
level
of
concern
at
the
typical
rate
for
all
occupational
exposure
scenarios
assessed
when
appropriate
PPE
or
engineering
controls
are
considered.

Post­
application
exposures
occur
as
a
result
of
being
in
an
environment
that
has
been
previously
treated
with
a
pesticide.
Occupational
post­
application
scenarios
were
not
assessed
because
most
worker
re­
entry
exposure
is
considered
unlikely,
i.
e.
resmethrin
is
not
used
on
agricultural
field
crops,
and
worker
re­
entry
exposures
to
treat
food
handling
establishments
warehouses,
and
outdoor
premises
are
not
expected
to
occur
reoutinely
for
Pest
Control
Operators
(
PCOs).
Also,
there
are
few
handler
noncancer
or
cancer
occupational
scenarios
of
risk
concern,
and
all
handler
scenarios
are
able
to
be
mitigated
with
minimal
PPE.
The
only
restricted­
entry
interval
(
REI)
has
been
established
according
to
the
Worker
Protection
Standard
(
WPS)
for
greenhouses
at
12
hours
for
workers
re­
entering
after
treatment
with
resmethrin.
For
professional
applications
to
homes,
food
handling
establishments
or
other
buildings,
no
one
will
be
allowed
to
enter
for
4
hours
following
an
application
and
the
area
must
be
ventilated
with
fresh
air
before
anyone
re­
enters.
12
Ecological
Risk
EPA's
screening
level
assessment
for
resmethrin
indicates
potential
exceedences
of
levels
of
concern
(
LOCs)
for
some
classes
of
organisms.
The
scenario
assessed
for
ecological
risk
was
wide
area
mosquito
abatement
sprays
at
maximum
(
0.007
lb
ai/
acre)
and
typical
rates
(
0.0035
lb
ai/
acre).
The
risk
quotients,
in
general,
are
low
(
less
than
7).
Freshwater
and
estuarine/
marine
invertebrates
show
the
highest
acute
RQs
of
all
taxa
(
range
from
<
0.05
to
6.5).
The
resmethrin
screening
level
ecological
risk
assessment
shows
no
acute
or
chronic
risk
to
endangered
or
non­
endangered
mammals,
and
shows
some
risk
to
birds.
Resmethrin
does
pose
an
acute
risk
to
non­
target
insects
such
as
honeybees.
No
data
were
submitted
to
evaluate
the
risk
of
resmethrin
exposure
to
nontarget
terrestrial
or
aquatic
plants;
however,
it
is
unlikely
that
resmethrin
poses
a
phytotoxic
concern
based
on
its
neurotoxic
mode
of
action.

Summary
of
Mitigation
Measures
EPA
has
determined
that
the
currently
registered
uses
of
resmethrin
are
eligible
for
reregistration
provided
the
mitigation
measures
outlined
in
this
document
are
implemented
through
label
amendments.
Mitigation
measures
include:

For
Residential
Exposure:

To
reduce
post­
application
exposure
to
adults
and
children:
 
Resmethrin
homeowner
products
applied
as
indoor
aerosol
space
sprays
must
be
labeled
to
instruct
users
to
keep
all
people
and
pets
away
from
treated
areas
for
2
hours
after
application.
Additionally,
these
products
must
be
labeled
to
instruct
the
user
to
ventilate
the
room
for
20
minutes
with
fresh
air
before
re­
occupying
the
treated
area.
 
Pest
control
operators
(
PCOs)
applying
indoor
space
sprays
or
fogs
will
be
required
to
inform
clients
that
they
may
not
re­
enter
the
treated
area
for
4
hours
after
application
and
that
the
client
must
ventilate
the
treated
area
before
re­
entering
for
20
to
120
minutes
depending
on
the
size
of
the
treated
area.
 
Manufacturing
use
labels
must
contain
the
following
statements:
"
Not
for
formulation
into
end
use
products
for
use
in
indoor
metered
spray
systems."
"
Not
for
formulation
into
end
use
products
for
use
in
outdoor
misting
systems."

For
Occupational
Exposure:

To
reduce
mixer,
loader,
handler
and
applicator
exposure:
 
All
mixers,
loaders,
and
applicators
using
liquid
formulations
of
resmethrin
are
required
to
wear
gloves
for
dermal
protection.
 
Applicators
using
foggers
in
indoor
spaces
are
required
to
wear
a
respirator
for
protection
against
inhalation
risk
and
coveralls
over
long
pants
and
shirts
for
dermal
protection.
 
Applicators
using
ready­
to­
use
aerosol
formulations
are
required
to
wear
gloves
for
dermal
protection.
13
 
For
products
intended
for
wide
area
mosquito
abatement
programs,
chemical­
resistant
gloves
are
required
for
all
mixers,
loaders
and
handlers
except
applicators.
 
The
Agency
incident
report
recommends
appropriate
protective
respiratory
equipment
for
individuals
who
are
likely
to
have
substantial
contact
with
resmethrin.
Because
mosquito
abatement
handlers
may
be
exposed
to
resmethrin
on
a
regular
basis,
enclosed
cabs
are
required
for
ULV
truck­
mounted
mosquito
abatement
spray
applications,
and
enclosed
cockpits
are
required
for
ULV
aerial
mosquito
abatement
spray
applications.
 
A
12­
hour
restricted
entry
interval
(
REI)
is
required
for
workers
re­
entering
treated
greenhouses
after
resmethrin
applications.
In
addition,
the
greenhouse
must
be
ventilated
with
fresh
air
prior
to
re­
entry.

For
Ecological
Exposure:

To
reduce
ecological
exposure:
 
Products
labeled
for
wide
area
mosquito
abatement
must
state
a
maximum
application
rate
of
0.007
lb
ai/
acre,
and
state
a
maximum
yearly
application
limit
of
0.2
lb
ai/
acre.
 
Release
height
requirement
for
rotary
wing
of
no
less
than
75
feet
above
the
ground
or
canopy,
for
fixed
wing
of
no
less
than
100
feet
above
the
ground
or
canopy.
 
Environmental
hazard
statements
informing
user
of
toxicity
to
fish,
aquatic
invertebrates,
and
oysters/
shrimp.
 
Statement
informing
user
of
toxicity
to
bees
visiting
treated
area.

Previously,
resmethrin
labels
often
did
not
specify
label
rates.
The
rates
below
will
serve
as
maximum
application
rates
for
registered
resmethrin
products.
 
Products
labeled
for
use
on
Livestock,
Farm
Animals,
and
Pets
(
Direct
Application):
Product
must
contain
0.35%
ai.
or
less.

 
Products
labeled
for
use
in
Outdoor
Sites
(
Commercial,
Recreational,
Domestic
Outdoor
Sites,
Agricultural
Structures,
Agricultural
Premises,
and
Agricultural
Equipment):
0.25
lb
ai
per
acre.

 
Products
labeled
for
use
in
Space
Applications
(
Indoor
Food
Handling/
Processing/
Eating
Establishments;
Commercial
Structure
Premises
and
Equipment;
Domestic
Structure
Premises
and
Equipment):
0.001
lb
ai
per
1000
ft2.

 
Products
labeled
for
use
in
Surface
Crack
and
Crevice
Application
(
Indoor
Food
Handling/
Processing/
Eating
Establishments;
Commercial
Structure
Premises
and
Equipment;
Domestic
Structure
Premises
and
Equipment):
0.242
lb
ai
per
1000
ft2.

Stewardship
Language
 
To
lessen
potential
risks
to
aquatic
organisms
from
resmethrin
use
around
the
home,
the
Agency
is
requiring
directions
for
use
on
both
professional
and
consumer­
use
products
for
use
in
residential
settings.
These
use
directions
include
best
management
and
stewardship
practices
which
are
formulation
specific
and
will
serve
to
reduce
the
potential
run­
off
and
drift
that
can
occur
from
applications
of
these
products.
14
15
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.

Resmethrin
is
a
member
of
the
pyrethroid
class
of
pesticides.
Although
all
pyrethroids
alter
nerve
function
by
modifying
the
normal
biochemistry
and
physiology
of
nerve
membrane
sodium
channels,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids
because
there
are
multiple
types
of
sodium
channels,
and
it
is
currently
unknown
whether
all
pyrethroids
have
similar
effects
on
all
channels.
In
addition,
the
Agency
does
not
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function,
e.
g.,
nerve
excitability,
nor
do
we
understand
how
these
key
events
interact
to
produce
their
compound­
specific
patterns
of
neurotoxicity.
There
is
ongoing
research
by
both
EPA's
Office
of
Research
and
Development
and
the
pyrethroid
registrants
to
evaluate
the
differential
biochemical
and
physiological
actions
of
pyrethroids
in
mammals.
This
research
is
expected
to
be
completed
by
2007.
When
the
results
of
this
research
are
available,
the
Agency
will
make
a
determination
of
common
mechanism
of
toxicity
as
a
basis
for
assessing
cumulative
risk.
For
information
regarding
EPA's
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
of
toxicity,
see
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

The
Agency
made
its
reregistration
eligibility
determination
(
RED)
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
resmethrin
are
eligible
for
reregistration
provided
the
mitigation
and
labeling
16
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
under
docket
number
EPA­
HQOPP
2005­
0284.

II.
Chemical
Overview
A.
Regulatory
History
Two
chemicals
are
included
in
the
resmethrin
case,
resmethrin
and
bioresmethrin,
as
listed
below
in
Table
1.
Resmethrin
was
first
registered
in
the
U.
S.
in
1967.
Bioresmethrin
was
initially
registered
in
the
U.
S.
in
1973.
Resmethrin
and
bioresmethrin
are
in
the
same
chemical
case
because
of
their
similar
chemical
structures
and
use
patterns.
The
Registration
Standard
and
associated
data
call­
ins
(
DCIs)
were
issued
for
these
two
chemicals
in
December
of
1988.
Resmethrin
is
classified
as
a
General
Use
Pesticide
for
all
uses
except
for
the
ultra­
low
volume
(
ULV)
mosquito
control
use.
The
resmethrin
ULV
spray
for
mosquito
control
is
classified
as
a
Restricted
Use
Pesticide
due
to
acute
aquatic
organism
toxicity.

Another
DCI
was
issued
for
resmethrin
in
October
1995
that
required
a
foliar
dissipation
study
and
dermal
and
inhalation
passive
dosimetry
exposure
studies
for
resmethrin
and
bioresmethrin.
This
RED
reflects
a
reassessment
of
all
the
data
reviewed
to
date
on
resmethrin.
As
of
October
28,
2005,
registrants
of
all
products
containing
bioresmethrin
have
requested
voluntary
cancellation,
and
therefore
products
containing
bioresmethrin
were
not
included
in
any
risk
assessments.

TABLE
1.
Ingredients
in
Resmethrin
Chemical
Case
(
0421)
PC
Code
Chemical
Name
CAS
Number
Status
097801
Resmethrin
10453­
86­
8
Dietary
and
non­
dietary
uses
being
reregistered.
097802
Bioresmethrin
28434­
01­
7
Since
all
bioresmethrin
products
have
been
proposed
for
voluntary
cancellation
and
no
bioresmethrin
products
are
currently
sold
in
the
U.
S.,
bioresmethrin
was
not
assessed.
Because
it
is
expected
that
no
registrations
for
bioresmethrin
will
remain,
bioresmethrin
will
not
be
reregistered.

There
are
currently
two
manufacturing­
use
product
registrants,
Valent
BioScience
and
Bayer
Environmental
Science.
Valent
BioScience
supports
the
household
and
17
commercial
uses
of
resmethrin,
and
Bayer
Environmental
Science
supports
the
mosquito
adulticide
use.

B.
Chemical
Identification
TABLE
2.
Resmethrin
Nomenclature
PC
Code
097801
Resmethrin
Chemical
structure
O
O
CH
3
C
H
3
C
H
3
CH
3
O
Common
name
Resmethrin
Molecular
Formula
C22H26O3
Molecular
Weight
338.45
IUPAC
name
5­
benzyl­
3­
furylmethyl
(
1RS,
3RS;
1RS,
3SR)­
2,2­
dimethyl­
3­(
2­
methylprop­
1­
enyl)­
cyclopropanecarboxylate
or
5­
benzyl­
3­
furylmethyl
(
1RS)­
cis­
trans­
2,2­
dimethyl­
3­(
2­
methylprop­
1­
enyl)­
cyclopropanecarboxylate
or
5­
benzyl­
3­
furylmethyl
(
±
)
­
cis­
trans­
chrysanthemate
CAS
name
[
5­(
phenylmethyl)­
3­
furanyl]
methyl
2,2­
dimethyl­
3­(
2­
methyl­
1­
propenyl)­
cyclopropanecarboxylate
CAS
#
10453­
86­
8
C.
Resmethrin
Use
Profile
Type
of
Pesticide:
Insecticide
Summary
of
Use:
Resmethrin
is
a
synthetic
Type
I
pyrethroid
insecticide
registered
for
control
of
insects
in
residential,
commercial
and
industrial
settings,
and
in
animal
living
areas.
Resmethrin
is
also
registered
for
use
in
food
handling
establishments
and
as
a
restricted
use
pesticide
when
used
in
ULV
spray
to
control
adult
mosquitoes
in
the
interest
of
public
health.

Use
sites:
Food
uses
include
crack
and
crevice
spray
and
enclosed
space
fog
in
food
handling
establishments
such
as
food
processing/
handling
plants,
restaurants,
commercial
food
item
transportation,
and
food
storage
facilities.
There
are
no
agricultural
uses
registered
for
resmethrin.
18
Non­
food
uses
include
animal
kennel
and
sleeping
quarters;
commercial
warehouses;
indoor
and
outdoor
use
in
commercial,
institutional,
and
industrial
premises;
hospitals;
indoor
and
outdoor
use
in
domestic
dwellings;
and
application
to
ornamental
plants.

Public
health
uses
include
wide
area
treatments
for
mosquito
control
as
an
ultra­
low
volume
(
ULV)
liquid
spray.

Target
Organisms:
Resmethrin
is
used
to
control
a
broad
spectrum
of
flying
and
crawling
insects.

Mode
of
Action:
Resmethrin
works
by
interacting
with
sodium
channels
in
the
peripheral
and
central
nervous
system
of
target
organisms.

Tolerances:
There
is
currently
one
tolerance
established
for
resmethrin
under
40
CFR
180.525.
The
tolerance
is
established
at
3.0
parts
per
million
(
ppm)
for
use
of
resmethrin
as
an
insecticide
in
food
handling
and
storage
areas
as
a
space
spray,
spot
treatment,
or
crack
and
crevice
treatment.

The
Agency
is
not
proposing
any
new
tolerances.

Use
Classification:
Commercial
and
residential
use:
General
Use
Pesticide
Public
health
mosquito
abatement
use:
Restricted
Use
Pesticide
Formulations:
Resmethrin
is
formulated
as
ready­
to­
use
pressurized
liquid
spray,
emulsifiable
concentrate,
and
soluble
concentrate.

Methods
of
Application:
Equipment:
Applications
are
made
with
hand
held
equipment
such
as
ready­
to­
use
spray
containers,
aerosol
cans,
thermal
fog
generators,
electric
foggers,
backpack
sprayers,
and
hand
held
sprayers.
Applications
are
also
made
with
aircraft
and
ground
equipment
such
as
truckmounted
sprayers.

Application
Methods:
Application
methods
include
aerial
and
truck­
mounted
ULV
sprays,
animal
shampoos
and
sprays,
ready­
to­
use
spray,
and
other
sprays
using
handheld
application
equipment.

Use
rates:
Maximum
single
application
rates
range
from
0.007
pound
active
ingredient
per
acre
(
lb./
a.
i./
A)
for
mosquito
control
to
0.25
lb./
a.
i./
A
for
outdoor
commercial,
recreational,
and
domestic
sites,
and
agricultural/
farm
structures.
The
maximum
indoor
crack
and
crevice
application
rate
is
0.242
lb./
a,
i./
1000
feet
squared
(
ft2),
and
19
the
maximum
enclosed
area
space
application
is
0.001
lb./
a.
i./
1000
ft3.

There
are
currently
no
limits
on
the
number
of
applications
per
year
for
any
use
site.

Application
Timing:
Resmethrin
products
used
indoors
may
be
applied
at
any
time
of
the
year.
Outdoor
products
are
generally
applied
during
warmer
months
of
the
year
when
nuisance
flying
and
crawling
insects
are
active.
Resmethrin
mosquito
abatement
products
are
applied
when
adult
mosquitoes
are
active
or
when
mosquito
borne
diseases
are
a
concern.

Annual
usage:
An
estimated
50,000
pounds
of
resmethrin
are
used
annually.
The
majority
of
resmethrin
is
used
for
adult
mosquito
control.
Resmethrin
is
also
used
by
homeowners
for
indoor
and
outdoor
insect
control,
by
pest
control
operators
for
insect
control,
by
industrial
and
commercial
service
personnel
for
crack
and
crevice
treatment,
and
for
insect
control
on
pets.

Technical
registrants:
Valent
BioSciences
and
Bayer
Environmental
Science
III.
Summary
of
Resmethrin
Risk
Assessments
The
following
is
a
summary
of
EPA's
human
health
and
environmental
fate
and
effects
findings
and
conclusions
for
resmethrin
as
presented
fully
in
the
documents,
"
Resmethrin
HED
Revised
Risk
Assessment
for
Reregistration
Eligibility
Document
(
RED)
PC
Code
097801;
DP
Barcode
No.
326088,"
revised
per
comments
received
during
the
60­
day
public
comment
period,
dated
February
23,
2006,
and
"
EFED
RED
Chapter
for
Resmethrin,
Revision
Phase
3;
DP
Barcode
No.
D326094;"
revised
per
comments
received
during
the
60­
day
public
comment
period
and
dated
March
8,
2006.

A.
Human
Health
Risk
Assessment
The
Agency
has
conducted
a
human
health
risk
assessment
for
resmethrin
for
the
purposes
of
making
a
reregistration
eligibility
decision.
The
Agency
evaluated
the
toxicology,
product
and
residue
chemistry,
and
occupational/
residential
exposure
studies
and
determined
that
the
data
are
adequate
to
support
a
reregistration
decision.
Details
of
the
risk
assessments
and
separate
supporting
disciplinary
documents
are
available
in
the
electronic
docket.
A
summary
of
the
human
health
risk
assessment
findings
and
conclusions
are
provided
below.

1.
Toxicity
(
For
a
complete
discussion,
see
Section
4.0
of
the
human
health
risk
assessment.)
20
The
toxicological
database
for
resmethrin
is
considered
adequate
to
characterize
potential
hazards
and
for
FQPA
determination.
Resmethrin
has
low
acute
toxicity
via
the
oral,
dermal,
and
inhalation
routes
of
exposure.
It
is
not
an
eye
or
skin
irritant
nor
is
it
a
skin
sensitizer.
Table
3
below
shows
the
acute
toxicity
profile
for
resmethrin.

Table
3.
Acute
Toxicity
Profile
­
Resmethrin
Guideline
No.
Study
Type
MRID(
s)
Results
Toxicity
Category
870.1100
Acute
oral
[
rat]
42076201
LD50
=
6091mg/
kg
(
m)
4639
mg/
kg(
f)
III
870.1200
Acute
dermal
[
rabbit]
42076202
LD50
>
2000
mg/
kg
III
870.1300
Acute
inhalation
[
rat]
42153701
LC50
=
5.28
mg/
L
IV
870.2400
Acute
eye
irritation
[
rabbit]
42076203
PIS
=
2.3
at
1
hr.
only
IV
870.2500
Acute
dermal
irritation
[
rabbit]
42076204
PIS
=
0.0
IV
870.2600
Skin
sensitization
[
guinea
pig]
42153702
Negative
­
Buehler
No
Subchronic
and
Chronic
Effects
Liver
toxicity
is
the
most
sensitive
endpoint
following
resmethrin
subchronic
and
chronic
exposure
by
the
oral
route.
The
liver
effects
include
increased
weight,
hepatocellular
vacuolization
and
hypertrophy
at
higher
doses,
and
increased
enzymes.
A
subchronic
oral
study
in
the
rat
demonstrated
histopathological
liver
toxicity
and
a
rangefinding
study
in
the
mouse
showed
increased
hepatic
vacuolization
and
liver
enlargement.
A
subchronic
oral
dog
study
revealed
slightly
increased
liver
weight
that
was
not
associated
with
microscopic
changes
or
clinical
pathology.
The
chronic
oral
gavage
dog
study
showed
decreased
body
weight
gain
and
food
consumption
in
both
sexes,
cataract
development
in
male
dogs,
and
increased
liver
weight
in
both
sexes
of
dogs.
The
twoyear
oral
study
in
mice
indicates
slight
increases
in
mortality,
and
the
two­
year
rat
oral
toxicity
study
indicates
slight
decreases
in
body
weight
in
females
and
anemia
in
males.

Evidence
of
Neurotoxicity
Resmethrin
elicits
adverse
neurotoxic
effects
by
interacting
with
sodium
channels
in
the
peripheral
and
central
nervous
system
of
target
organisms.
Neurotoxic
effects,
such
as
tremors,
nasal
discharge,
blanching
of
the
feet,
and
tear­
shedding,
were
observed
in
two
non­
guideline
modified
neurotoxicity
screening
batteries
in
rats.

Dermal
and
Inhalation
Toxicity
No
systemic
effects
were
observed
in
a
three­
week
dermal
toxicity
study
in
rabbits.
A
subchronic
rat
inhalation
study
produced
behavioral
effects
(
sneezing,
agitated
grooming),
decrease
in
body
weight
for
females,
and
decrease
in
glucose
levels
in
males
at
the
lowest
dose
tested.

Developmental
Toxicity
21
In
an
oral
rat
developmental
study,
both
maternal
and
developmental
effects
were
observed,
including
decreased
maternal
body
weight
and
maternal
food
consumption
and
delayed
ossification
and
decreased
fetal
body
weight
in
rat
fetuses.

There
are
two
rabbit
developmental
studies
for
resmethrin.
In
a
1979
rabbit
study,
no
maternal
toxicity
was
observed
at
any
dose
level;
however,
developmental
toxicity
was
observed.
Effects
included
increased
incidence
of
fused
sternebrae
and
extra
sternebrae.
In
the
more
recent
(
1991)
rabbit
developmental
study,
maternal
toxicity
(
decreased
body
weight
gain)
was
observed
at
the
low
dose
and
developmental
toxicity
at
the
high
dose.
The
more
recent
rabbit
developmental
study
replaces
the
older
study.

Reproductive
Toxicity
Two
rat
reproduction
studies
were
used
to
determine
the
chronic
dietary
endpoint.
Reproductive
effects,
such
as
increased
mortality,
decreased
survival
in
pups,
decreased
pup
birth
weight
and
lactation
weight,
and
increased
incidence
of
stillborn
pups,
were
observed
in
a
two­
generation
rat
reproduction
study.
A
three­
generation
rat
reproduction
study
is
considered
co­
critical
for
the
chronic
dietary
endpoint
with
effects
of
mortality
and
decreased
pup
body
weight.

FQPA
Safety
Factor
Resmethrin
did
not
demonstrate
qualitative
or
quantitative
evidence
of
increased
susceptibility
in
the
rat
developmental
study
or
the
two­
generation
or
three­
generation
rat
reproduction
studies,
and
there
is
a
low
degree
of
concern
for
residual
uncertainties
for
pre­
or
postnatal
susceptibility.
In
rat
developmental
and
reproduction
studies,
maternal
or
parental
effects
occurred
at
the
same
doses
at
which
the
fetal
or
offspring
effects
were
found
to
occur.
Additionally,
there
was
no
increase
in
severity
of
the
fetal
or
offspring
effects
in
comparison
to
the
parental
effects.
In
contrast,
resmethrin
did
display
increased
quantitative
susceptibility
in
the
1979
rabbit
developmental
study
since
developmental
effects
occurred
in
the
absence
of
the
maternal
toxicity
at
the
same
dose
level.
The
endpoint
selected
is
protective
of
developmental
effects.

The
10X
FQPA
Safety
Factor
was
retained
in
addition
to
the
conventional
uncertainty
factor
of
100x
(
10x
for
interspecies
variability
and
10x
for
intraspecies
variability),
due
to
database
uncertainty
(
the
absence
of
subchronic
and
developmental
neurotoxicity
studies).
The
Agency
is
requiring
a
developmental
neurotoxicity
study
at
this
time
for
the
following
reasons:
the
toxicology
data
base
for
resmethrin
lacks
a
guideline
acute
and
13­
week
neurotoxicity
study
in
rats;
resmethrin
is
a
member
of
the
class
of
synthetic
pyrethroids,
which
are
neurotoxic
chemicals;
and
there
is
evidence
of
quantitative
increases
in
susceptibility
in
a
rabbit
developmental
study.

Dermal
Absorption
22
A
dermal
absorption
estimate
of
2.0%
was
selected
based
in
part
on
a
recent
dermal
absorption
study
for
pyrethrins
(
2004)
in
humans
that
indicated
0.22%
dermal
absorption.
This
study
was
further
corroborated
by
other
human
dermal
estimates
with
cypermethrin
showing
dermal
absorption
of
0.3­
1.8%.
EPA's
use
of
human
dermal
absorption
studies
in
the
resmethrin
risk
assessment
is
in
accordance
with
the
Agency's
Final
Rule
promulgated
on
January
26,
2006,
related
to
Protections
for
Subjects
in
Human
Research,
which
is
codified
in
40
CFR
Part
26.

Carcinogenic
Potential
(
For
more
information
on
the
classification
of
carcinogenic
potential,
see
section
4.4.9
of
the
human
health
risk
assessment.)

Resmethrin
was
classified
as
"
Likely
to
be
Carcinogenic
to
Humans"
by
the
Cancer
Assessment
Review
Committee
(
CARC)
of
the
Office
of
Pesticide
Programs
in
March
2005.
This
classification
is
based
on
increased
incidences
of
benign
and
malignant
liver
tumors
in
female
rats
and
male
mice.
A
low­
dose
extrapolation
approach
was
applied
to
the
experimental
animal
data
in
order
to
estimate
human
cancer
risk.
The
unit
risk,
Q*
1
(
mg/
kg/
day)­
1
of
resmethrin
based
upon
male
mouse
liver
combined
adenoma
and/
or
carcinoma
tumor
rates
is
5.621
x
10­
2
in
human
equivalents.

Mutagenicity
Resmethrin
is
not
mutagenic,
as
demonstrated
in
the
Ames
assay,
in
vitro
chromosome
aberration
assay
in
Chinese
hamster
ovary
cells,
and
the
unscheduled
DNA
synthesis
(
UDS)
assay
in
rat
hepatocytes.

Endocrine
Disruptor
Effects
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
for
resmethrin
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,
resmethrin
may
be
subject
to
additional
screening
and/
or
testing.
23
A
summary
of
the
resmethrin
studies
reviewed
for
risk
assessment
are
available
in
section
4.0
of
the
human
health
risk
assessment.
A
summary
of
the
endpoints
selected
for
risk
assessment
is
presented
in
Table
4
below.

Table
4.
Summary
of
Toxicological
Doses
and
Endpoints
for
Resmethrin
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
(
all
population)
No
endpoint
of
concern
Chronic
Dietary
(
all
populations)

(
MRID)
Dose
for
risk
assessment
=
35
mg/
kg/
day
UF
=
1000
(
10
for
intraspecies
variation,
10
for
interspecies
extrapolation,
and
FQPA
10
for
database
uncertainty)

Chronic
RfD
=
0.035
mg/
kg/
day
FQPA
SF
=
10
cPAD
=
0.035
mg/
kg/
day
[
The
FQPA
safety
factor
is
retained
due
to
database
uncertainty
and
is
included
in
the
calculation
of
the
RfD.]
2­
Generation
Reproduction
Study
­
rat
Reproductive/
Offspring
LOAEL
=
70.8
mg/
kg/
day
based
on
decreased
mating
index
in
males
and
females
during
the
second
F1
mating,
decreased
viability
index
and
decreased
pup
weight
in
all
generations
at
birth
and
during
lactation,
and
possible
slight
increase
in
stillborn
pups
in
the
F1a
and
F2a
generations.
3­
generation
reproduction
study
is
co­
critical
­
LOAEL
=
47
mg/
kg/
day
Incidental
Oral
Short­,
Intermediate­
Term
Maternal
toxicity
NOAEL
=
40
mg/
kg/
day
Residential
LOC
for
MOE
=
1000
[
The
FQPA
safety
factor
is
retained
due
to
database
uncertainty.]

Occupational
LOC
for
MOE
=
NA
Rat
Developmental
Toxicity
Study
Maternal
LOAEL
=
80
mg/
kg/
day
based
on
reduced
weight
gain
and
reduced
food
consumption
during
gestation
Dermal
Short­,
Intermediate­,
and
Long­
Term
Oral
Developmental
NOAEL
=
30
mg/
kg/
day
(
dermal
absorption
rate
=
2%)
Residential
LOC
for
MOE
=
1000
[
The
FQPA
safety
factor
is
retained
due
to
database
uncertainty.]

Occupational
LOC
for
MOE
=
100
Oral
Rabbit
Developmental
Toxicity
Study
Developmental
LOAEL
=
100
mg/
kg/
day
based
on
increased
incidence
of
skeletal
variations
and
a
possible
marginal
increase
in
resorbed
litters
in
the
absence
of
maternal
toxicity
Inhalation
Short­,
Intermediate­,
and
Long­
Term
Inhalation
LOAEL
=
0.1
mg/
L
(
28.2
mg/
kg/
day)
Residential
LOC
for
MOE
=
1000
[
The
FQPA
safety
factor
is
retained
due
to
database
uncertainty.]

Occupational
LOC
for
MOE
=
100
90­
Day
Inhalation
Toxicity
Study
Inhalation
LOAEL
=
0.1
mg/
L
(
28.2
mg/
kg/
day)
based
on
clinical
signs
within
the
first
month,
decreased
glucose
levels
in
males,
a
decrease
(­
13%)
in
body
weight
gain
during
weeks
1­
4
and
an
increase
in
BUN
(
32%)
at
week
12
in
females.
24
Table
4.
Summary
of
Toxicological
Doses
and
Endpoints
for
Resmethrin
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
Cancer
(
oral,
dermal,
inhalation)
Classification:
The
CARC
(
4/
13/
05)
classified
resmethrin
as
"
likely
to
be
carcinogenic
to
humans"
and
recommended
a
low­
dose
linear
extrapolation
Q1*
for
resmethrin.
Oral
Q1*
=
5.621
x
10­
2
in
human
equivalents
based
upon
male
mouse
liver
combined
adenoma
and/
or
carcinoma
tumor
rates
UF
=
uncertainty
factor,
FQPA
SF
=
Special
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,
NA
=
Not
Applicable
2.
Dietary
Risk
(
Food
+
Water)

(
For
a
complete
discussion,
see
Section
6.0
of
the
human
health
risk
assessment.)

Dietary
risk
assessment
incorporates
both
exposure
to
and
toxicity
of
a
given
pesticide.
The
risk
is
expressed
as
a
percentage
of
a
maximum
acceptable
dose
(
i.
e.,
the
dose
which
will
result
in
no
unreasonable
adverse
health
effects).
This
dose
is
referred
to
as
the
population
adjusted
dose
(
PAD).
The
PAD
is
equivalent
to
the
Reference
Dose
(
RfD)
divided
by
the
FQPA
Safety
Factor.
EPA
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
PAD.

3.
Acute
Dietary
Risk
No
acute
dietary
analysis
was
completed
because
no
acute
oral
endpoint
of
concern
attributable
to
a
single
exposure
was
established
in
acute
dietary
studies.

4.
Drinking
Water
Dietary
Exposure
and
Risk
(
For
a
complete
discussion,
see
section
6.2
of
the
human
health
risk
assessment)

Drinking
water
exposure
to
pesticides
can
occur
through
groundwater
and
surface
water
contamination.
EPA
considers
both
acute
(
one
day)
and
chronic
(
lifetime)
drinking
water
risks
and
uses
either
modeling
or
actual
monitoring
data,
if
available,
to
estimate
those
risks.
Modeling
is
carried
out
in
tiers
of
increasing
refinement,
but
is
designed
to
provide
high­
end
estimates
of
exposure.

The
drinking
water
assessment
for
resmethrin
considers
contribution
from
resmethrin
alone.
Since
no
monitoring
data
were
available
for
resmethrin,
estimated
drinking
water
concentrations
(
EDWCs)
were
calculated
from
models.
The
EDWCs
were
incorporated
directly
into
the
chronic
and
cancer
aggregate
dietary
exposure
assessment.
The
EDWCs
were
based
on
application
methods,
rates,
and
use
sites
that
would
likely
yield
the
highest
drinking
water
concentrations.
25
The
most
important
environmental
route
of
dissipation
for
resmethrin
is
photodegradation.
The
aqueous
photolysis
half­
life
for
resmethrin
is
22
minutes
in
seawater
and
47
minutes
in
distilled
water.
Resmethrin
is
generally
slow
to
biodegrade
in
the
environment
under
aerobic
and
anaerobic
conditions;
half­
lives
are
198
days
for
aerobic
soil
metabolism,
37
days
for
aerobic
aquatic
metabolism,
and
682
days
for
anaerobic
soil
metabolism.
Hydrolysis
occurs
slowly
at
a
range
of
pH
values
(
half­
life
>
89
days
at
pHs
5­
9).
Resmethrin
has
relatively
low
mobility
in
soils
and
may
be
expected
to
adsorb
to
suspended
solids,
organic
matter,
and
sediment
(
Koc
range
508­
3179).
Like
other
pyrethroids,
it
appears
to
have
a
low
potential
to
reach
groundwaters,
but
it
may
reach
bodies
of
waters
adjacent
to
the
treated
areas
via
runoff
events
accompanies
by
erosion.
Volatilization
is
not
expected
to
be
an
important
transport
process
for
resmethrin
due
to
its
low
vapor
pressure
and
Henry's
Law
constant.

Surface
water
 
Tier
II
EDWCs
were
calculated
using
Pesticide
Root
Zone
Model
(
PRZM)
v
3.12
beta
and
Exposure
Analysis
Modeling
System
(
EXAMS)
v
2.98.04.02.
As
shown
in
Table
5
below,
the
Agency
calculated
a
chronic
EDWC
in
surface
water
of
0.13
ppb,
based
on
the
annual
average
surface
water
estimate
using
the
PRZM
Florida
turf
scenario.
Resmethrin
is
not
used
as
a
turf
application,
but
this
scenario
was
used
to
conservatively
estimate
residues
when
resmethrin
is
used
as
a
mosquito
adulticide
over
parks,
golf
courses,
and
other
grassy
areas
without
a
canopy.

Ground
water
 
Tier
I
EDWCs
for
ground
water
were
calculated
using
the
Screening
Concentration
in
Ground
Water
(
SCI­
GROW)
model.
The
Agency
calculated
a
chronic
EDWC
in
ground
water
of
0.016
ppb.

Monitoring
Data
 
No
monitoring
data
for
resmethrin
were
found
in
searches
of
the
United
States
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
database
or
the
EPA
Storage
and
Retrieval
(
STORET)
database.

Results
of
a
relatively
limited
monitoring
study
are
available
for
resmethrin
in
Suffolk
County,
New
York,
before
and
after
mosquito
spraying
in
2002­
2004.
The
maximum
concentration
of
resmethrin
was
0.291
ppb.
This
concentration
is
in
the
range
of
values
predicted
for
the
most
conservative
scenario.

Table
5.
Estimated
Drinking
Water
Concentrations
(
EDWCs)
for
Resmethrin
Duration
of
Exposure
Surface
Water
EDWCs
Ground
Water
EDWCs
Chronic
0.13
ppb
0.016
ppb
5.
Chronic
Non­
Cancer
Dietary
Risk
(
Food
+
Water)

The
chronic
endpoint
for
all
populations
is
based
on
a
two­
generation
rat
oral
study
in
which
reproductive
effects
such
as
decreased
survival
in
pups,
decreased
pup
birth
weight
and
lactation
weight,
and
increased
incidence
of
stillborn
pups,
were
observed
at
the
LOAEL
of
70.8
mg/
kg/
day.
The
NOAEL
was
35
mg/
kg/
day.
A
total
uncertainty
factor
of
1000X
was
applied
for
the
chronic
dietary
assessment,
incorporating
10X
for
interspecies
extrapolation,
10X
for
intraspecies
variability
and
a
10X
FQPA
26
safety
factor
for
database
uncertainty.
The
chronic
population
adjusted
dose
(
cPAD)
was
calculated
to
be
35
mg/
kg/
day
divided
by
a
safety
factor
of
1000
=
0.035
mg/
kg/
day.

Resmethrin
residues
may
remain
in
or
on
food
items,
resulting
from
its
use
in
food
handling
areas
and
storage
areas
as
a
space
treatment,
spot
application,
or
crack
and
crevice
treatment.
Resmethrin
is
not
applied
to
agricultural
food
crops
so
separate
tolerances
for
residues
in
or
on
specific
plant
or
animal
commodities
do
not
exist.
There
is
only
one
tolerance
established
for
resmethrin
in
40
CFR
180.525
set
at
3.0
ppm
for
residues
of
resmethrin
in
or
on
food
items
resulting
from
its
use
in
food
handling
and
storage
areas.
The
chronic
dietary
exposure
assessments
for
resmethrin
were
based
on
data
from
a
residue
study
conducted
with
a
crack
and
crevice
spray
in
food
handling
establishments.
Data
pertaining
to
the
nature
and
magnitude
of
resmethrin
residue
in
or
on
food
items
resulting
from
the
currently
registered
use
in
food
handling
establishments
have
been
evaluated
and
deemed
adequate
by
the
Agency.
The
chronic
dietary
risk
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM
FCID,
Version
2.03).

Residue
data
from
a
study
on
the
magnitude
of
the
residues
in
foods
from
application
of
resmethrin
in
food
handling
establishments
as
a
crack
and
crevice
treatment
was
used
for
dietary
analysis.
Data
on
percent
of
food
handling
establishments
treated
was
conservatively
estimated
at
10%
of
all
food
handling
establishments
nationwide
based
on
registrant­
submitted
data.
DEEM
default
processing
factors
were
used.
An
EDWC
point
estimate
value
for
drinking
water
contribution
to
exposure
was
used.
The
surface
annual
average
EDWC
was
0.13
ppb
using
a
Tier
2
aquatic
model
PRZM­
EXAMS.
The
groundwater
annual
average
EDWC
was
0.016
ppb.

Estimated
exposure
to
resmethrin
from
food
and
drinking
water
is
below
the
Agency's
level
of
concern
for
all
population
subgroups
at
2%
of
the
cPAD
for
the
U.
S.
population
and
7%
of
the
cPAD
for
children
1­
2
years
old,
which
is
the
subgroup
with
the
highest
estimated
exposure.

Table
6.
Resmethrin
Chronic
Dietary
and
Drinking
Water
Exposure
Estimate
and
Percent
of
Chronic
PAD
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.035
0.000736
2
Children
1­
2
years
old
0.035
0.002463
7
The
resmethrin
dietary
exposure
assessment
overestimates
the
use
of
resmethrin
due
to
several
factors.
The
Agency
assumes
that
10%
of
food
handling
establishments
are
treated
with
resmethrin.
The
Agency
believes
this
is
an
overestimate
of
resmethrin
use
in
food
handling
establishments
because,
according
to
a
proprietary
survey
of
food
handling
establishments,
less
than
10%
of
food
handling
establishments
are
expected
to
be
treated
with
resmethrin.
A
study
on
the
magnitude
of
the
residues
in
foods
was
used
for
the
resmethrin
dietary
assessment
(
MRID
41239901).
In
this
study
a
single
application
of
a
0.25%
ai
ready­
to­
use
resmethrin
product
was
applied
to
representative
food
handling
establishments
as
a
crack
and
crevice
treatment.
Of
the
226
food
samples
27
analyzed,
detectable
residues
of
resmethrin
(
greater
than
0.003
ppm)
were
found
in
or
on
only
15
samples
of
food.
An
upper­
bound
residue
of
0.38
ppm
(
the
highest
detect
in
a
non­
tissue
commodity)
was
used
for
all
commodities
in
DEEM­
FCID
except
meat,
poultry
and
eggs.
For
meat,
poultry
and
eggs,
0.125
ppm
was
used
since
this
was
the
highest
detect
in
a
tissue
commodity.
Because
the
highest
detected
residue
was
assumed
for
all
commodities
despite
residues
found
in
only
15
of
226
samples,
these
residue
estimates
likely
overestimate
the
resmethrin
residues
found
on
food
commodities.

6.
Cancer
Dietary
Risk
(
Food
+
Water)

The
cancer
dietary
risk
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM
FCID,
Version
2.03).
The
resmethrin
dietary
and
drinking
water
cancer
risk
assessment
was
slightly
refined
using
residue
data
from
a
study
on
the
magnitude
of
the
residues
in
foods
from
application
of
resmethrin
to
food
handling
establishments
as
a
crack
and
crevice
treatment.
In
this
study
a
single
application
of
a
0.25%
ai
ready­
to­
use
resmethrin
product
was
applied
to
representative
food
handling
establishments
as
a
crack
and
crevice
treatment.
A
residue
of
0.01
ppm
,
the
average
of
all
detected
residues
in
food
in
the
study
mentioned
above,
was
used
for
all
commodities
except
water
in
the
cancer
dietary
exposure
analysis.
An
EDWC
(
residue
level)
of
0.13
ppb
was
used
for
water
in
the
cancer
dietary
exposure
analysis
(
for
surface
water
analysis
the
PRZM
Florida
turf
scenario
was
used
because
it
yields
a
high­
end
residue
value).
The
results
of
the
cancer
analysis
indicate
the
estimated
dietary
and
drinking
water
cancer
risk
associated
with
the
resmethrin
uses
do
not
exceed
EPA's
level
of
concern,
as
estimated
excess
lifetime
cancer
risk
for
the
general
U.
S.
population
was
1.6
x
10­
6,
as
shown
in
Table
7
below.

TABLE
7.
Resmethrin
Cancer
Dietary
and
Drinking
Water
Exposure/
Risk
Estimate
Population
Subgroup
Q1*
Exposure
(
mg/
kg/
day)
Cancer
Risk
General
U.
S.
Population
0.05621
0.000028
1.6x10­
6
The
cancer
dietary
assessment
overestimates
the
likely
risks
from
use
of
resmethrin.
The
only
food
use
for
resmethrin
is
use
in
food
handling
establishments
such
as
food
processing/
handling
plants,
restaurants,
commercial
food
item
transportation,
and
food
storage
facilities.
The
cancer
risk
estimate
assumes
that
10%
of
all
food
handling
establishments
are
treated
with
resmethrin.
The
assumption
is
an
overestimation
of
exposure
according
to
a
proprietary
survey
food
handling
establishments
use
of
pesticides.
Additionally,
in
the
resmethrin
cancer
dietary
assessment,
the
Agency
assumed
that
the
full
limit
of
detection
(
LOD)
level
was
found
for
all
non­
residue
detections
in
the
Dietary
Exposure
Evaluation
Model
(
DEMM­
FCID).
In
the
past
the
Agency
has
used
½
of
the
LOD
value
for
all
non­
residue
detections
when
calculating
dietary
risk.
In
using
the
full
LOD,
the
Agency
has
conservatively
estimated
dietary
risk.
Additional
data
may
allow
refinement
of
this
estimate.
Cancer
dietary
and
drinking
water
risk
from
resmethrin
is
not
of
concern
to
the
Agency.

7.
Residential
Risk
28
(
For
a
complete
discussion,
see
section
7.0
of
the
human
health
risk
assessment.)

Residential
handlers
can
be
exposed
to
a
pesticide
while
mixing,
loading,
or
applying
(
handling)
a
pesticide,
or
after
entering
areas
where
the
pesticide
had
previously
been
applied
by
a
professional
applicator
of
public
health
official.
Residential
noncancer
risks
are
measured
by
a
margin
of
exposure
(
MOE),
which
determines
how
close
the
residential
exposure
comes
to
a
no
observed
adverse
effect
level
(
NOAEL)
taken
from
animal
studies.
For
resmethrin
residential
exposures,
a
MOE
of
1000
is
considered
protective
for
inhalation,
dermal,
and
incidental
oral
residential
exposure
and
risk.
The
MOE
includes
a
10x
for
interspecies
extrapolation,
a
10x
for
intraspecies
variation,
and
a
10x
FQPA
safety
factor
for
database
uncertainty
due
to
missing
toxicology
studies.

The
Agency
calculates
the
residential
risks
with
the
assumption
that
the
residential
handler
wears
shoes,
socks,
short­
sleeved
shirt,
and
shorts.
For
non­
cancer
risk,
both
short­
and
intermediate­
term
exposures
were
assessed
for
residential
handlers
and
residential
post­
application
exposures
based
on
use
and
exposure
patterns
of
registered
resmethrin
products.
Inhalation,
dermal,
and
incidental
ingestion
were
considered
to
be
the
routes
of
exposure
for
citizens
exposed
to
resmethrin.
Maximum
labeled
rates
were
used
for
the
non­
cancer
residential
handler
and
non­
cancer
residential
post­
application
risk
assessments.

Residential
cancer
risks
are
estimated
by
calculating
the
probability
that
an
exposed
person
may
develop
cancer.
Cancer
risk
estimates
below
1x
10­
6
are
generally
below
the
Agency
LOCs.
However,
given
the
many
conservative
assumptions
in
its
low
dose,
linear
extrapolation
cancer
model,
the
Agency
generally
considers
risks
up
to
3x
10­
6
to
be
within
the
negligible
risk
range,
and
therefore
below
the
level
of
concern.
For
the
residential
space
spray
application
exposure
scenario,
the
Agency
assumed
that
a
private
citizen
can
be
exposed
to
a
pesticide
throughout
their
lifetime
(
70
years)
via
nonhandler
exposure,
or
50
years
for
handler
exposure
(
mixing,
loading,
or
applying
a
pesticide).
The
exposure
frequency
used
for
the
resmethrin
residential
handler
cancer
risk
assessment
was
assumed
to
be
3
days
per
year
at
average
or
typical
application
rates
for
resmethrin.
Inhalation
and
dermal
exposure
were
considered
to
be
the
routes
of
exposure
for
the
cancer
risk
assessment
for
residential
handlers
exposed
to
resmethrin.

The
endpoints
selected
for
residential
uses
of
resmethrin
for
non­
cancer
and
cancer
risk
assessment
are
presented
in
Table
8
below.

Table
8.
Summary
of
Toxicological
Doses
and
Endpoints
for
Resmethrin
for
Use
in
the
Residential
and
Occupational
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
29
Table
8.
Summary
of
Toxicological
Doses
and
Endpoints
for
Resmethrin
for
Use
in
the
Residential
and
Occupational
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Incidental
Oral
Short­,
Intermediate­
Term
Maternal
toxicity
NOAEL
=
40
mg/
kg/
day
Residential
LOC
for
MOE
=
1000
(
LOC
for
residential
exposures
includes
an
FQPA
safety
factor
of
10
due
to
database
uncertainty)
Occupational
=
NA
Rat
Developmental
Toxicity
Study
Maternal
LOAEL
=
80
mg/
kg/
day
based
on
reduced
weight
gain
and
reduced
food
consumption
during
gestation
Dermal
Short­,
Intermediate­,
and
Long­
Term
Oral
Developmental
NOAEL
=
30
mg/
kg/
day
(
dermal
absorption
rate
=
2%)
Residential
LOC
for
MOE
=
1000
(
LOC
for
residential
exposures
includes
an
FQPA
safety
factor
of
10
due
to
database
uncertainty)

Occupational
LOC
for
MOE
=
100
Oral
Rabbit
Developmental
Toxicity
Study
Developmental
LOAEL
=
100
mg/
kg/
day
based
on
increased
incidence
of
skeletal
variations
and
a
possible
marginal
increase
in
resorbed
litters
in
the
absence
of
maternal
toxicity
Inhalation
Short­,
Intermediate­,
and
Long­
Term
Inhalation
LOAEL
=
0.1
mg/
L
(
28.2
mg/
kg/
day)
Residential
LOC
for
MOE
=
1000
(
LOC
for
residential
exposures
includes
an
FQPA
safety
factor
of
10
due
to
database
uncertainty)

Occupational
LOC
for
MOE
=
100
90­
Day
Inhalation
Toxicity
Study
Inhalation
LOAEL
=
0.1
mg/
L
(
28.2
mg/
kg/
day)
based
on
clinical
signs
within
the
first
month,
decreased
glucose
levels
in
males,
a
decrease
(­
13%)
in
body
weight
gain
during
weeks
1­
4
and
an
increase
in
BUN
(
32%)
at
week
12
in
females.

Cancer
(
oral,
dermal,
inhalation)
Classification:
The
Agency
classified
resmethrin
as
"
likely
to
be
carcinogenic
to
humans"
and
recommended
a
low­
dose
linear
extrapolation
of
a
Q1*
for
resmethrin.
Oral
Q*
=
5.621
x
10­
2
in
human
equivalents
based
upon
male
mouse
liver
combined
adenoma
and/
or
carcinoma
tumor
rates
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern,
NA
=
Not
Applicable
8.
Residential
Handler
Risk
(
For
a
complete
discussion,
see
7.2
of
the
human
health
risk
assessment.)

The
residential
handler
assessment
considered
both
dermal
and
inhalation
exposures
for
adults
applying
resmethrin
in
outdoor
areas
with
a
hand
held
fogger
and
low
pressure
hand
wand,
and
in
indoor
areas
applying
resmethrin
as
an
aerosol
spray.
The
exposure
duration
considered
for
non­
cancer
risk
assessment
was
short­
and
intermediate­
term
based
on
resmethrin
use
and
exposure
patterns.
For
cancer
risk,
the
Agency
assumes
that
a
residential
handler
is
exposed
to
a
pesticide
for
50
years
for
handler
exposure
(
mixing,
loading,
or
applying
a
pesticide).
Application
rates
for
all
30
exposure
scenarios
assessed
are
based
on
information
provided
by
a
review
of
active
labels.
For
the
non­
cancer
assessment,
maximum
labeled
rates
are
used.
For
the
cancer
assessment,
typical
or
average
rates
are
used
in
risk
assessment.
Data
from
the
Pesticide
Handler
Exposure
Database
(
PHED)
or
Occupational
and
Residential
Exposure
Task
Force
(
ORETF)
data
bases
were
used
to
assess
residential
handler
exposures.

Residential
Handler
Exposure
Scenarios
 
Mixing,
loading,
and
applying
liquid
spray
formulation
by
low­
pressure
handwand
for
indoor
surface
spray
and
crack
and
crevice
treatment
application
 
Mixing,
loading,
and
applying
liquid
formulation
by
fogger
for
general
outdoor
application.

Residential
Handler
Non­
Cancer
Risk
All
MOE
estimates
for
residential
handlers
range
from
2400
to
8.5
million
and
are
not
of
concern
to
the
Agency.
All
residential
handler
risks
are
below
the
Agency's
level
of
concern
(
all
MOEs
are
above
1000).

Residential
Cancer
Risk
Cancer
risk
estimates
are
within
the
acceptable
range
for
residential
handlers
(
i.
e.,
less
than
3x
10­
6).
The
cancer
estimates
for
residential
handler
exposure
to
resmethrin
range
from
1x
10­
6
to
2.4x
10­
6.

9.
Residential
Post­
application
Risk
(
For
more
information,
see
section
7.2
of
the
human
health
risk
assessment.)

The
Agency
uses
the
term
"
post­
application"
to
describe
exposures
to
individuals
that
occur
as
a
result
of
being
in
an
environment
that
has
been
previously
treated
with
a
pesticide.
Resmethrin
can
be
used
in
many
areas
that
can
be
frequented
by
the
general
population
including
residential
areas
(
indoor
and
outdoor
areas).
As
a
result,
individuals
can
be
exposed
by
entering
these
areas
if
they
have
been
previously
treated.
Resmethrin
can
also
be
used
on
companion
animals,
which
can
lead
to
exposure
by
contact
with
the
treated
animals.
Further,
resmethrin
is
used
in
wide
area
mosquito
abatement
programs
as
a
mosquito
adulticide.
It
can
be
applied
to
wide
areas
through
ultra­
low
volume
(
ULV)
spraying,
which
can
result
in
post­
application
exposure
to
the
general
population.

The
residential
post­
application
non­
cancer
risk
assessment
considered
both
dermal
and
inhalation
exposures
on
a
short­
and
intermediate­
term
basis.
Scenarios
assessed
include
adults
and
children
exposed
to
an
outdoor
mosquito
adulticide
application,
adults
and
children
re­
entering
treated
lawns,
and
adults
and
children
exposed
to
an
indoor
space
spray
application.
Other
non­
cancer
exposures
assessed
include
incidental
ingestion
risks
to
toddlers
reentering
treated
lawns,
playing
on
vinyl
floor
and
carpet
after
indoor
fogger
treatment,
and
incidental
ingestion
and
dermal
risks
to
toddlers
playing
with
pets
after
the
pets
have
been
treated
with
a
resmethrin
spray
formulation.
Application
rates
for
all
exposure
scenarios
assessed
are
based
on
active
labels.
For
non­
cancer
assessment,
maximum
labeled
rates
are
used.
Post
application
31
exposure
estimates
were
developed
using
OPP
standard
operating
procedures,
Non­
Dietary
Exposure
Task
Force
Exposure
(
NDETF)
data,
Spray
Drift
Task
Force
Exposure
data,
and
Residential
Exposure
Joint
Venture
(
REJV)
data.

Residential
Post­
Application
Exposure
Scenarios
 
Inhalation
exposure
from
application
of
mosquito
adulticide
from
fixed
wing
aircraft
and/
or
helicopter
 
Inhalation
exposure
from
application
of
mosquito
adulticide
from
ULV
truck­
mounted
sprayer
 
Toddler
incidental
ingestion
of
residue
from
exposed
turf
grass
via
hand­
to­
mouth
activities
 
Toddler
incidental
ingestion
of
residue
via
object­
to­
mouth
activity
while
on
exposed
turf
grass
 
Toddler
incidental
ingestion
of
soil
from
treated
area
 
Toddler
incidental
ingestion
of
residues
deposited
on
carpet
via
hand­
to­
mouth
activities
after
use
of
total
release
foggers
 
Toddler
incidental
ingestion
of
residues
deposited
on
vinyl
flooring
via
hand­
to­
mouth
activities
after
use
of
total
release
foggers
 
Toddler
incidental
ingestion
of
residues
on
pets
via
hand­
to­
mouth
activities
and
dermal
exposure
after
pet
treatment
 
Inhalation
exposure
by
adult
applicator
handler
scenarios
during
and
after
aerosol
space
spray
application;
post­
application
inhalation
exposure
to
aerosol
spray
by
child
 
Dermal
Exposure
to
adults
and
children
reentering
treated
lawns
Post­
Application
Non­
Cancer
Risk
Most
risk
estimates
for
residential
post­
application
risk
range
from
2400
to
8.5
million
and
are
not
of
concern
to
the
Agency.
Most
residential
post­
application
risks
are
below
the
Agency's
level
of
concern
(
most
MOEs
are
above
1000).

The
non­
cancer
risk
estimate
for
a
child
exposed
to
an
indoor
aerosol
space
spray
exceeds
the
Agency's
level
of
concern
(
MOE
=
900).
This
exposure
may
occur
when
a
child
enters
a
room
within
10
minutes
after
a
resmethrin
indoor
aerosol
space
spray
application.
This
risk
can
be
mitigated
by
label
instructions
that
inform
residents
to
keep
all
people
and
pets
out
of
sprayed
rooms
for
2
hours
after
application.

Post­
Application
Cancer
Risk
Resmethrin
is
used
to
kill
adult
mosquitoes
by
exposing
them
directly
to
spray
containing
resmethrin.
Resmethrin
is
used
by
public
health
officials
with
federal,
state,
county,
or
local
governments;
mosquito
control
districts;
military
officials
in
charge
of
public
health
for
military
installations;
or
contractors
or
others
employed
by
public
health
agencies.

For
cancer
risk,
the
Agency
assumes
that
a
private
citizen
can
be
exposed
to
a
pesticide
for
70
years.
For
the
resmethrin
residential
post­
application
cancer
risk
assessment,
typical
rates
were
used.
Data
from
the
Occupational
and
Residential
Exposure
Task
Force
(
ORETF)
data
bases
were
used
to
assess
residential
post
32
application
exposures.
Additionally,
the
registrants
submitted
Residential
Exposure
Joint
Venture
(
REJV)
data
to
estimate
resmethrin
residential
use
frequency.

Two
residential
bystander
post
application
cancer
risk
scenarios
were
assessed
for
adults
exposed
to
resmethrin
when
it
is
used
as
an
ultra­
low
volume
(
ULV)
mosquito
adulticide
spray.
(
EPA
did
not
assess
cancer
risk
separately
for
children
in
residential
post­
application
scenarios
because
cancer
risks
are
assessed
assuming
70
years
of
exposure;
thus
they
are
included
in
the
adult
cancer
assessment.)
The
resmethrin
risk
assessment
estimates
that
an
adult
could
be
exposed
to
resmethrin
when
applied
as
an
aerial
ULV
mosquito
adulticide
spray
up
to
365
times
a
year
for
70
years
before
the
Agency's
cancer
risk
level
of
concern
is
exceeded.
When
resmethrin
ULV
mosquito
adulticide
spray
is
applied
through
a
truck­
mounted
sprayer,
the
Agency
estimates
that
an
adult
could
be
exposed
up
to
125
days
a
year
for
70
years
before
exceeding
the
Agency's
cancer
risk
level
of
concern.
Assumptions
used
in
the
residential
post­
application
risk
assessment
include
an
adult
breathing
rate
is
1.0
meters
cubed
(
m3)
per
hour
and
an
exposure
duration
is
less
than
or
equal
to
20
minutes.
Typical
rates
were
used
in
the
residential
post­
application
cancer
risk
assessment.
In
addition,
for
the
truck
mounted
ULV
spray
application,
a
dilution
factor
of
0.01
was
applied
to
the
airborne
concentration
at
the
maximum
application
rate
(
i.
e.,
1%
of
product
released
was
considered
to
be
available
for
exposure).
EPA
does
not
expect
residential
bystander
exposures
to
approach
125
days
a
year
for
70
years,
therefore
residential
bystander
risk
is
not
of
concern.

Table
9.
Estimated
Resmethrin
Post­
application
Inhalation
Cancer
Risks
­
Mosquito
Adulticide
and
Estimated
Number
of
Exposure
Days
Per
Year
at
which
Cancer
Risks
are
Not
of
Concern
(
Risk
<
1x10­
6
)

Exposed
Individual
Average
Application
Rate
lb
ai/
acre
Breathing
Zone
Concentration
(
mg/
m3)
Lifetime
Average
Daily
Dose
(
mg/
kg/
day)
Number
of
Exposure
Days
Aerial
Spray
(
Fixed
Wing
and
Rotary
Aircraft)

Adult
0.003
0.0015
0.00004
>
365
Truck
Mounted
ULV
Sprayer
Adult
0.003
0.0110
0.0003
125
10.
Aggregate
Risk
(
For
a
complete
discussion,
see
section
8.0
of
the
human
health
risk
assessment.)

In
accordance
with
the
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
33
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.
For
this
assessment,
EPA
aggregated
exposures
from
resmethrin
in
food
and
water
with
exposure
from
residential
uses.

Acute
Aggregate
Risk
An
acute
aggregate
risk
assessment
is
not
required,
since
no
appropriate
endpoint
attributable
to
a
single
exposure
was
identified
in
the
resmethrin
database.

Short­,
Intermediate­,
and
Long­
Term
Aggregate
Non­
Cancer
Risk
Aggregate
non­
cancer
risk
is
normally
estimated
as
the
risk
associated
with
exposures
through
food
and
drinking
water,
as
well
as
residential
exposures
through
the
oral,
dermal,
and
inhalation
routes.
An
aggregate
non­
cancer
risk
assessment
for
resmethrin
was
conducted
only
for
food
and
water,
however,
because
endpoints
selected
for
the
residential
routes
of
exposure
are
not
based
on
common
toxic
effects.
As
described
earlier,
aggregate
non­
cancer
risk
estimates
for
food
and
water
do
not
exceed
the
Agency's
level
of
concern.

Aggregate
Cancer
Risk
The
aggregate
cancer
assessment
combines
lifetime
estimated
dietary
and
residential
risks.
For
resmethrin,
aggregate
dietary
risk
(
food
and
drinking
water)
is
1.6
x
10­
6,
and
residential
risk
is
1x
10­
6.
The
resulting
aggregate
risk
estimate
is
2.6x
10­
6,
which
falls
generally
within
the
range
of
acceptable
risk
to
the
Agency.

Table
10.
Estimated
Aggregate
Cancer
Risk
from
Dietary/
Drinking
Water
and
Residential
Exposures
to
Resmethrin
Dietary/
Drinking
water
Risk
Residential
Exposure
Risk*
Aggregate
Cancer
Risk
1.6x10­
6
1x10­
6
2.6x10­
6
*
Estimated
risk
from
indoor
aerosol
application
assuming
reentry
2
hrs
after
application
EPA
has
concluded
that
aggregate
cancer
risks
are
likely
overestimates,
based
on
several
factors.
First,
food
risks
are
only
somewhat
refined.
The
cancer
risk
estimate
assumes
that
10%
of
food
handling
establishments
are
treated
with
resmethrin.
This
assumption
is
an
overestimation
of
exposure
according
to
a
proprietary
survey
of
pesticides
used
in
food
handling
establishments.
Additionally,
in
the
resmethrin
cancer
dietary
assessment,
the
Agency
assumed
that
the
full
limit
of
detection
(
LOD)
level
was
found
for
all
non­
residue
detections
in
the
Dietary
Exposure
Evaluation
Model
(
DEEMFCID
In
the
past
the
Agency
has
used
½
of
the
LOD
value
for
all
non­
residue
detections
when
calculating
dietary
risk.
In
using
the
full
LOD,
the
Agency
has
conservatively
estimated
dietary
risk,
which
results
in
high­
end
estimates
of
exposures
to
residues
in
food.
Second,
drinking
water
exposure
estimates
were
developed
using
the
Tier
2
model
PRZM­
EXAMS
which
also
results
in
high­
end
estimates
of
potential
exposure
to
resmethrin.
Finally,
the
residential
exposure
scenario
which
was
aggregated
with
the
dietary
risks
is
the
one
with
the
highest
estimated
exposure
and
risk
(
indoor
aerosol
space
spray)
of
all
the
residential
scenarios
assessed.
For
the
indoor
aerosol
space
spray
scenario,
the
Agency
assumes
that
a
residential
handler
performing
an
indoor
34
aerosol
space
spray
application
does
so
three
times
a
year
for
50
years,
and
is
additionally
exposed
for
70
years
to
post­
application
residues.
These
are
high­
end
exposure
assumptions.
Additionally,
given
the
relatively
low
usage
of
resmethrin
(
50,000
lbs
ai
per
year)
the
probability
of
co­
occurrence
of
these
exposures
is
low.

11.
Cumulative
Risk
Resmethrin
is
a
member
of
the
pyrethroid
class
of
pesticides.
Although
all
pyrethroids
alter
nerve
function
by
modifying
the
normal
biochemistry
and
physiology
of
nerve
membrane
sodium
channels,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids
because
there
are
multiple
types
of
sodium
channels,
and
it
is
currently
unknown
whether
all
pyrethroids
have
similar
effects
on
all
channels.
In
addition,
the
Agency
does
not
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function,
e.
g.,
nerve
excitability,
nor
do
we
understand
how
these
key
events
interact
to
produce
their
compound­
specific
patterns
of
neurotoxicity.
There
is
ongoing
research
by
both
EPA's
Office
of
Research
and
Development
and
the
pyrethroid
registrants
to
evaluate
the
differential
biochemical
and
physiological
actions
of
pyrethroids
in
mammals.
This
research
is
expected
to
be
completed
by
2007.
When
the
results
of
this
research
are
available,
the
Agency
will
make
a
determination
of
common
mechanism
of
toxicity
as
a
basis
for
assessing
cumulative
risk.
For
information
regarding
EPA's
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
of
toxicity,
see
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

12.
Occupational
Risk
(
For
a
complete
discussion,
see
section
10.0
of
the
human
health
risk
assessment.)

Workers
can
be
exposed
to
a
pesticide
while
mixing,
loading,
or
applying
a
pesticide,
or
re­
entering
a
treated
site.
Handler
non­
cancer
risks
are
measured
by
a
margin
of
exposure
(
MOE),
which
determines
how
close
the
occupational
exposure
comes
to
a
NOAEL
taken
from
animal
studies.
For
resmethrin
non­
cancer
risk,
an
MOE
greater
than
or
equal
to
100
has
been
determined
to
be
adequately
protective
for
shortterm
(
1
to
30
days),
intermediate­
term
(
1
to
6
months)
and
long­
term
(
greater
than
6
months)
exposures
and
risk.

Handler
cancer
risks
are
estimated
by
calculating
the
probability
that
an
exposed
handler
may
develop
cancer.
For
agricultural
workers,
the
Agency
will
typically
seek
to
reduce
the
individual
risks
to
be
greatest
extent
feasible,
preferably
to
10­
6
or
less.
The
Agency
seeks
to
reduce
risks
between
10­
6
and
10­
4
to
the
greatest
extent
feasible,
through
requiring
additional
protective
clothing
or
equipment
or
changes
in
application
methods,
taking
benefits
into
account.
For
cancer
risk
estimates,
the
Agency
typically
assumes
that
handler
exposure
duration
to
a
pesticide
is
240
days
a
year
for
35
years.
Typical
application
rates
were
used
in
the
occupational
cancer
risk
assessment.
Inhalation
and
dermal
were
considered
to
be
the
routes
of
exposure
for
the
handler
cancer
risk
assessment.
35
Occupational
Toxicity
The
following
table
lists
the
endpoints
used
for
the
occupational
risk
assessment
for
resmethrin.

Table
11.
Summary
of
Toxicological
Doses
and
Endpoints
for
resmethrin
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Dermal
Short­,
Intermediate­,
and
Long­
Term
Oral
Developmental
NOAEL
=
30
mg/
kg/
day
(
dermal
absorption
rate
=
2%)
Occupational
LOC
for
MOE
=
100
Oral
Rabbit
Developmental
Toxicity
Study
Developmental
LOAEL
=
100
mg/
kg/
day
based
on
increased
incidence
of
skeletal
variations
and
a
possible
marginal
increase
in
resorbed
litters
in
the
absence
of
maternal
toxicity
Inhalation
Short­,
Intermediate­,
and
Long­
Term
Inhalation
LOAEL
=
0.1
mg/
L
(
28.2
mg/
kg/
day)
Occupational
LOC
for
MOE
=
100
90­
Day
Inhalation
Toxicity
Study
Inhalation
LOAEL
=
0.1
mg/
L
(
28.2
mg/
kg/
day)
based
on
clinical
signs
within
the
first
month,
decreased
glucose
levels
in
males,
a
decrease
(­
13%)
in
body
weight
gain
during
weeks
1­
4
and
an
increase
in
BUN
(
32%)
at
week
12
in
females.

Cancer
(
oral,
dermal,
inhalation)
Classification:
The
Agency
(
4/
13/
05)
classified
resmethrin
as
"
likely
to
be
carcinogenic
to
humans"
and
recommended
a
low­
dose
linear
extrapolation
of
a
Q1*
for
resmethrin.
Oral
Q*
=
5.621
x
10­
2
in
human
equivalents
based
upon
male
mouse
liver
combined
adenoma
and/
or
carcinoma
tumor
rates
UF
=
uncertainty
factor,
FQPA
SF
=
Special
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,
NA
=
Not
Applicable
Occupational
Handler
Exposure
The
Agency
initially
calculates
the
handler
risks
using
baseline
work
clothing
(
e.
g.,
long
sleeve
shirt
and
long
pants),
no
gloves,
and
no
respirator.
If
there
is
a
concern
at
this
level,
the
Agency
considers
the
use
of
protective
measures
(
e.
g.,
personal
protective
equipment
and
engineering
controls)
to
lower
the
exposure.
Personal
protective
equipment
(
PPE)
can
include
an
additional
layer
of
clothing,
chemicalresistant
gloves,
and
a
respirator.
Common
examples
of
engineering
controls
include
enclosed
cabs,
closed
loading
systems,
and
water­
soluble
packaging.

Occupational
handlers
of
resmethrin
include
mixers,
loaders,
or
applicators
in
indoor
and
outdoor
environments.
EPA
assessed
risk
scenarios
for
pesticide
control
operator
handlers,
wide
area
mosquito
abatement,
and
direct
application
to
pets
and
some
farm
animals.
36
Pesticide
Control
Operator
Handler
Scenarios
 
Mixing,
loading,
and
applying
liquids
with
a
high
pressure
hand
wand
sprayer
in
a
nonfood
greenhouse
 
Mixing,
loading
and
applying
liquids
with
a
low
pressure
hand
wand
sprayer
in
a
nonfood
greenhouse
 
Mixing,
loading
and
applying
liquids
with
a
fogger
in
a
greenhouse
 
Mixing,
loading
and
applying
liquids
with
a
fogger
in
outdoor
sites
 
Mixing,
loading
and
applying
liquids
with
a
low
pressure
hand
wand
for
indoor
crack
and
crevice
treatment
 
Mixing,
loading
and
applying
liquids
with
a
low
pressure
hand
wand
in
food
handling/
processing/
eating
establishments
and
warehouses
for
crack
and
crevice
treatment
 
Mixing,
loading
and
applying
liquids
with
a
low
pressure
hand
wand
in
grain
storage
facilities.

Mosquito
Abatement
Scenarios
 
Mixing,
loading
liquid
for
aerial
application
 
Mixing,
loading
liquid
for
ULV
truck­
mounted
spray
application
 
Mixing,
loading,
and
applying
liquids
for
truck­
mounted
ULV
ground
spray
 
Mixing,
loading,
and
applying
liquids
with
a
low
pressure
hand
wand
application.

Direct
Application
to
Pets
and
Farm
Animals
 
Spray
application.

Exposure
analyses
were
performed
using
PHED,
ORETF
data,
or
the
National
Pest
Management
Association
(
NPMA)
Survey.

a.
Occupational
Non­
cancer
Handler
Summary
Occupational
handler
exposures
were
assessed
with
baseline
or
minimal
personal
protective
equipment.
Non­
cancer
exposure
and
risk
estimates
indicate
no
MOEs
of
concern
(
i.
e.,
all
MOEs
are
greater
than
100)
at
the
maximum
use
rate
for
all
occupational
exposure
scenarios
assessed
either
at
baseline
or
considering
the
use
of
chemical­
resistant
gloves.

When
workers
apply
resmethrin
with
a
low
pressure
handwand
with
no
PPE,
the
MOE
is
calculated
to
be
90.
When
gloves
are
added
for
this
scenario,
the
MOE
is
calculated
to
be
20,000
and
is
not
of
concern.

b.
Occupational
Cancer
Handler
Summary
The
cancer
risk
estimates
for
pesticide
control
operators
and
mosquito
abatement
personnel
are
presented
in
Table
12
below.

TABLE
12.
Estimated
Resmethrin
Exposure
&
Cancer
Risk
Estimate
for
Pesticide
Control
Operator
&
Mosquito
Abatement
37
Exp
Scenario
Dermal
Unit
Exposure
(
mg/
lb
ai)
Inhalation
Unit
Exposure
(
ug/
lb
ai)
Use
Site
Typical
Application
Rate
Daily
Area
Treated
Or
Amount
Handled
Cancer
Risk
Baseline
Cancer
Risk
Dermal
PPE
(
Baseline
+
Gloves)

Greenhouse
­
Non
Food
Mix/
Load/
Apply
Liquid
Formulation
High
Pressure
Handwand
2.5
120
Greenhouse
0.001
lb/
ai
gal
1000
gal/
day
4.
E­
05
NA
Low
Pressure
Handwand
100
30
Greenhouse
0.001
lb/
ai
gal
40
gal/
day
1.
E­
03
4.
E­
06
Handheld
Fogger
14
190
Greenhouse
0.001
lb/
ai
gal
10
gal/
day
4.
E­
05
NA
Outdoor
Sites
Mix/
Load/
Apply
Liquid
Formulation
Handheld
Fogger
14
190
Patio/
Yards/
Recreational
Areas
0.05
lb
ai/
acre
2
acre/
day
1.
E­
05
NA
Indoor
Homes/
Buildings
Mix/
Load/
Apply
Liquid
Formulation
Low
Pressure
Handwand
100
30
Contact
Spray/
Crack
&
Crevice
0.02
lbs/
1000
ft2
1
building/
day
avg
area
­
1600
ft2
2.
E­
05
NA
Indoor
Food
Handling/
Processing/
Eating
Establishments/
Non­
Food
Warehouses
Mix/
Load/
Apply
Liquid
Formulation
Low
Pressure
Handwand
Sprayer
100
30
Contact
Spray/
Crack
&
Crevice
0.02
lbs/
1000
ft2
1
facility/
per
day
10000
ft2
/
facility
1.
E­
04
NA
Indoor
Grain
Storage
Units
Mix/
Load/
Apply
Liquid
Formulation
Low
Pressure
Handwand
100
30
Contact
Spray/
Crack
&
Crevice
0.02
lbs/
1000
ft2
1
bin/
day
1000
ft2
/
bin
1.
E­
05
NA
Mosquito
Abatement
Mix/
Load
Liquid
Formulation
ULV
Truck
Mounted
Spray
(
Open
Cab)
2.9
1.2
Adulticide
0.003
lb
ai/
acre
3000
acre/
day
1.
E­
04
NA
ULV
Aerial
2.9
1.2
Adulticide
0.003
lb
ai/
acre
7500
acre/
day
4.
E­
04
1.
E­
05
Mosquito
Abatement
Apply
Liquid
Formulation
ULV
Truck
Mounted
Spray
(
Open
Cab)
0.36
4.5
Adulticide
0.003
lb
ai/
acre
3000
acre/
day
3.
E­
05
NA
Mosquito
Abatement
Mix/
Load/
Apply
Liquid
Formulation
Low
Pressure
Handwand
100
30
Adulticide
0.003
lb
ai/
acre
2
acre/
day
3.
E­
06
NA
Pet
Groomer
and
Veterinarian
Apply
Aerosol
Aerosol
190
1300
Pet
Spray
0.003
lb
ai
per
16
oz
can
1
pet/
day
½
can
spray/
pet
2.
E­
06
NA
In
use
scenarios
where
cancer
risk
estimates
exceeded
10­
4,
the
Agency
is
requiring
personal
protective
equipment
(
gloves)
to
reduce
exposure.
For
most
other
scenarios,
estimated
cancer
risks
are
between
10­
6
and
10­
4.
However,
because
the
exposure
inputs
to
these
estimates
are
conservative
and
likely
overestimate
actual
exposure,
no
additional
mitigation
will
be
required
at
this
time.
For
pest
control
operator
and
mosquito
abatement
scenarios,
assuming
full
day,
long­
term
application
for
each
application
method
may
significantly
overestimate
total
exposure.
Based
on
usage
data
38
of
likely
resmethrin
containing
pesticides
presented
in
a
National
Pest
Management
Association
survey,
this
assumption
would
result
in
significant
overestimate
of
exposure
for
PCOs.
Similarly,
assuming
continuous
usage
of
resmethrin
containing
pesticides
for
mosquito
abatement
applications
would
also
significantly
overestimate
total
exposure
based
on
personal
communication
with
mosquito
control
district
officials
regarding
current
usage
of
these
products.
Further,
based
on
current
usage,
the
assumption
for
cancer
risk
assessment
that
workers
are
exposed
for
240
days
per
year
for
35
years
should
be
considered
highly
conservative.
Default
assumptions
regarding
acres
treated
per
day
for
aerial
and
truck
mounted
ULV
sprayer
applications
for
mosquito
abatement
should
also
be
considered
conservative
based
on
resmethrin
specific
information
provided
by
the
registrant.
The
agency
used
default
assumptions
of
7500
acres
per
day
for
aerial
applications
and
3000
acres
per
day
for
ULV
applications.
The
registrant
cites
information
from
the
American
Mosquito
Control
Association
that
typically,
no
more
than
4000
acres
per
day
are
treated
by
aerial
application
and
no
more
than
400
acres
per
day
are
treated
by
truck­
mounted
ULV
spray
applications.

c.
Postapplication
Occupational
Risk
Post­
application
exposures
occur
as
a
result
of
being
in
an
environment
that
has
been
previously
treated
with
a
pesticide.
Occupational
post­
application
scenarios
were
not
assessed
because
worker
re­
entry
exposure
is
considered
unlikely
in
most
situations,
i.
e.
resmethrin
is
not
used
on
agricultural
field
crops,
and
worker
re­
entry
exposures
to
treated
food
handling
establishments,
warehouses,
greenhouses,
and
outdoor
premises
are
not
expected
to
occur
routinely
for
Pest
Control
Operators
(
PCOs).

The
only
restricted­
entry
interval
(
REI)
currently
established
under
the
WPS
is
for
greenhouses.
The
REI
will
be
maintained
at
12
hours
for
workers
re­
entering
a
greenhouse
after
treatment
with
resmethrin.

13.
Human
Incident
Data
In
evaluating
incidents
to
humans,
the
Agency
reviewed
reports
from
five
sources
including
the
OPP
Incident
Data
System
(
IDS),
Poison
Control
Centers
(
PCC),
California
Department
of
Pesticide
Regulation
(
CDPR),
National
Pesticide
Information
Center
(
NPIC),
and
National
Institute
of
Occupational
Safety
and
Health's
Sentinel
Event
Notification
System
for
Occupational
Risks
(
NIOSH
SENSOR).
The
majority
of
cases
involved
systemic
and
respiratory
effects,
such
as
headache,
nausea,
coughing,
dizziness,
and
shortness
of
breath.
The
Agency
incident
report
recommends
appropriate
protective
respiratory
equipment
for
individuals
who
are
likely
to
have
substantial
inhalation
exposure
to
resmethrin.
See
Chapter
IV
for
a
description
of
measures
to
address
this
concern.

B.
Environmental
Risk
Assessment
A
summary
of
the
Agency's
environmental
risk
assessment
for
resmethrin
is
presented
below.
More
detailed
information
associated
with
the
environmental
risk
from
39
the
use
of
resmethrin
can
be
found
in
the
"
EFED
RED
Chapter
for
Resmethrin,
Revision
Phase
3;
DP
Barcode
No.
D326094;"
revised
per
comments
received
during
the
phase
3
60­
day
public
comment
period
and
dated
March
8,
2006.

1.
Environmental
Fate
and
Transport
The
environmental
fate
database
is
sufficient
to
characterize
the
environmental
exposure
associated
with
resmethrin
use.
However,
EPA
intends
to
issue
a
DCI
as
part
of
this
RED
to
require
submission
of
additional
data
for
resmethrin
to
address
areas
of
uncertainty.
These
data
are
expected
to
confirm
the
conclusions
of
this
environmental
risk
assessment.

EPA
expects
all
the
isomers
of
resmethrin
to
have
similar
environmental
fate
characteristics.
The
most
important
route
of
dissipation
for
resmethrin
is
photolysis.
The
aqueous
photolysis
half­
life
for
resmethrin
is
very
short
(
22
minutes
in
seawater
and
47
minutes
in
distilled
water).
No
data
were
submitted
regarding
the
potential
for
resmethrin
to
undergo
photodegradation
on
soil
surfaces;
however,
current
labels
recommend
that
resmethrin
be
applied
in
the
early
morning
or
in
the
evening
to
prevent
photodegradation,
which
indicates
that
resmethrin
may
be
subject
to
relatively
rapid
photodegradation
in
the
terrestrial
environment.

Other
than
when
subjected
to
photolysis,
resmethrin
is
generally
slow
to
degrade.
The
aerobic
soil
metabolism
half­
life
is
198
days,
the
aerobic
aquatic
metabolism
halflife
is
37
days,
and
resmethrin
is
relatively
stable
to
anaerobic
soil
metabolism.
Hydrolysis
occurs
slowly
at
a
range
of
pH
values.
In
hydrolysis
studies,
the
resmethrin
half­
life
is
greater
than
89
days
at
pH
values
5
to
9.

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
resmethrin
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
certainty
and
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).
40
Table
13.
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
Restricted
Use
Resmethrin
products
used
for
wide
area
mosquito
abatement
are
classified
as
Restricted
Use
due
to
aquatic
toxicity.
All
applicators
for
wide
area
mosquito
abatement
must
be
certified
applicators
trained
in
pesticide
application
or
be
under
the
direct
supervision
of
someone
who
has
been
trained
in
pesticide
application.

a.
Risk
to
Aquatic
Organisms
i.
Fish
and
Invertebrate
Exposures
and
Toxicity
For
exposure
to
aquatic
fish
and
invertebrates,
EPA
considers
surface
water
only,
since
most
aquatic
organisms
are
not
found
in
ground
water.
The
aquatic
exposure
assessment
is
based
on
the
Tier
II
models
Pesticide
Root
Zone
Model
(
PRZM)
which
simulates
fate
and
transport
on
the
agricultural
field,
while
the
water
body
is
simulated
with
Exposure
Analysis
Modeling
System
(
EXAMS).
Simulations
are
run
for
multiple
years
based
on
the
thirty
years
of
daily
values
generated
during
the
simulation.

Wide
Area
Mosquito
Abatement
The
default
values
of
application
efficiency
(
95%)
and
spray
drift
(
5%),
currently
used
for
applications
to
agricultural
crops,
are
not
appropriate
for
applications
for
a
mosquito
adulticide
like
resmethrin.
Instead,
to
calculate
the
level
of
drift
from
this
type
of
application,
the
Agency
used
the
Agricultural
Dispersal
model
(
AGDISP)
version
8.07.
AGDISP
provides
a
better
estimate
of
spray
drift
for
ULV
applications.
AGDISP
estimates
for
resmethrin
ULV
spray
include
an
application
efficiency
of
40%
and
a
spray
drift
value
of
60.0%.

PRZM/
EXAMS
modeling
of
resmethrin
was
done
for
use
on
turf
to
simulate
mosquito
abatement
scenarios.
The
registrant­
defined
maximum
application
rate,
maximum
number
of
applications
per
year,
and
minimum
application
interval
were
modeled
to
represent
an
upper­
end
of
exposure
potential.
Scenarios
were
assessed
for
aerial
and
ground
applications.
Simulations
are
run
for
multiple
(
usually
30)
years
and
the
reported
EECs
represent
the
values
that
are
expected
once
every
ten
years
based
on
the
thirty
years
of
daily
values
generated
during
the
simulation.
41
The
maximum
application
rate
for
resmethrin
is
0.007
lb
ai/
A.
Resmethrin
registrants
have
defined
the
maximum
number
of
applications
per
year
to
be
50,
however,
limitations
in
PRZM/
EXAMS
prevented
modeling
more
than
26
applications
per
year.
The
estimate
of
26
applications
per
year
is
closer
to
the
registrant­
reported
typical
number
of
applications
per
year.
An
application
frequency
of
twice
per
week
(
every
3
or
4
days)
was
modeled.
Aquatic
estimated
environmental
concentrations
(
EECs)
generated
for
this
assessment
may
underestimate
actual
environmental
exposure
to
resmethrin
since
more
than
26
applications
may
be
applied
per
year.
Table
14
and
15
below
show
the
water
column
and
pore
water
EECs.

When
typical
rates
were
modeled
(
0.0035
lb
ai/
A,
3­
day
application
interval,
26
applications
per
year),
the
resulting
EECs
were
approximately
one­
half
the
values
observed
for
the
maximum
application
rate.
This
applies
for
the
peak,
21­
day,
and
60­
day
EECs.
A
complete
listing
of
EECs,
including
those
used
for
resmethrin
RQ
calculations
included
in
this
summary,
can
be
found
in
the
risk
tables
in
the
resmethrin
ecological
risk
assessment.

Table
14.
Water
column
EECs
(
ppb
or
µ
g/
L)
ecological
risk
assessment
for
ponds
of
various
depths
based
on
resmethrin
use
on
turf
(
using
maximum
application
rate
of
0.007
lb
ai/
acre).

Average
Pond
Depth
Application
Interval
Time­
point
for
EEC
6.6
ft.
=
2
m.

Peak
Value
0.777
21
Day
Value
0.575
3
days
60
Day
Value
0.547
Table
15.
Pore
water
EECs
(
ppb
or
µ
g/
L)
ecological
risk
assessment
for
ponds
of
various
depths
based
on
resmethrin
use
on
turf
(
using
typical
application
rate
of
0.007
lb
ai/
acre).

Average
Pond
Depth
Application
Interval
Time­
point
for
EEC
6.6
ft.
=
2
m.

Peak
Value
0.347
21
Day
Value
0.338
3
days
60
Day
Value
0.309
"
Down­
the­
Drain"
To
address
potential
resmethrin
release
to
domestic
wastewater
treatment
through
indoor
household
use,
EPA
used
the
Exposure
and
Fate
Assessment
Screening
Tool
(
EFAST
The
"
down­
the­
drain"
module
of
E­
FAST
is
designed
to
address
sources
of
resmethrin
that
could
potentially
be
disposed
in
wastewater.
The
acute
surface
water
EEC
for
resmethrin
is
1.15x
10­
4
ppb.
The
60­
day
EEC
for
resmethrin
is
8.9x
10­
6
ppb.
42
(
For
more
information,
see
section
III.
B.
2.
b.
of
the
EFED
assessment)

Aquatic
Toxicity
The
acute
fish
and
invertebrate
toxicity
data,
outlined
in
table
16
below,
indicate
that
resmethrin
is
very
highly
toxic
to
freshwater
fish
and
invertebrates
and
to
estuarine/
marine
fish
and
invertebrates.

Table
16.
Summary
of
Acute
Aquatic
Toxicity
Data
for
Resmethrin
Toxicity
Study
Test
Species
LC50
or
EC50
(
ppb)
Toxicity
Category
MRID/
Accession
No.
Freshwater
Fish
(
96­
hour)
Rainbow
trout
Oncorhynchus
mykiss
(
TGAI)
0.28
Very
highly
toxic
40098001
Freshwater
Invertebrate
(
48­
hour)
Water
flea
Daphnia
magna
(
TGAI)
3.10
Very
highly
toxic
40991210
Estuarine
/
Marine
Fish
Sheepshead
minnow
Cyprinodon
variegates
(
TGAI)
11
Very
highly
toxic
40991218
Estuarine
/
Marine
Invertebrates
Pink
shrimp
Penaeus
duorarum
(
TGAI)
1.30
Very
highly
toxic
40991217
Estuarine
/
Marine
Mollusks
No
Data
Both
freshwater
fish
and
estuarine/
marine
fish
early
life­
stage
chronic
toxicity
tests
were
used
to
evaluate
the
chronic
toxicity
of
resmethrin.
Results
from
the
freshwater
fish
early
life­
stage
toxicity
test
indicated
at
the
No
Observed
Adverse
Effect
Concentration
(
NOAEC)
of
0.32
ppb
and
an
associated
Lowest
Observed
Adverse
Effect
Concentration
(
LOAEC)
of
0.59
ppb.
The
basis
of
these
effect
levels
was
an
observed
decrease
in
larval
survival
of
resmethrin­
exposed
fish.
An
estuarine/
marine
early
fish
life­
stage
study
was
used
to
evaluate
the
toxicity
of
resmethrin
to
estuarine/
marine
fish.
The
most
sensitive
endpoint
was
juvenile
survival
with
a
NOAEC
of
1.9
ppb
and
a
LOAEC
of
4.1
ppb.
There
were
no
chronic
freshwater
invertebrate
or
estuarine/
marine
invertebrate
toxicity
data
available
for
this
assessment.

Table
17.
Summary
of
Chronic
Aquatic
Toxicity
Data
for
Resmethrin
Toxicity
Study
Test
Species
NOAEC
/
LOAEC
(
ppb)
Effects
at
LOAEC
MRID/
Accession
No.
Freshwater
Fish
Early
Life­
Stage
Rainbow
trout
Oncorhynchus
mykiss
0.32
/
0.59
Larval
survival
40991223
43
(
TGAI)
Estuarine
/
Marine
Fish
Early
Life­
Stage
Sheepshead
minnow
Cyprinodon
variegates
(
TGAI)
1.90
/
4.05
Juvenile
survival
43858304
ii.
Fish
and
Invertebrate
Risk
Risks
presented
in
this
section
are
estimates
of
fish
and
invertebrate
risk
that
may
occur
due
to
the
wide
area
mosquito
abatement
use
of
resmethrin,
or
from
exposure
modeled
for
the
"
down
the
drain"
scenario.

Freshwater
Fish
The
acute
risk
level
of
concern
(
LOC)
(
0.5)
and
acute
endangered
species
LOC
(
0.05)
are
exceeded
for
freshwater
fish
exposed
to
resmethrin.
The
RQ
range
is
from
2.78
for
the
technical
product
and
1.73
for
the
formulated
product.
The
LOC
for
chronic
risk
(
1)
is
exceeded
only
for
freshwater
fish
at
1.71
for
the
3­
day
modeled
interval.

Estuarine/
Marine
Fish
The
acute
risk
LOC
(
0.5)
is
not
exceeded
in
acute
risk
estimates
for
estuarine/
marine
fish.
The
endangered
species
acute
risk
LOC
(
0.05)
is
exceeded
for
estuarine/
marine
fish
exposed
to
formulated
resmethrin
(
RQ
0.48)
and
estuarine/
marine
fish
exposed
to
technical
resmethrin
(
RQ
=
0.07).
Chronic
risks
of
concern
(
1)
associated
with
estuarine/
marine
fish
exposed
to
resmethrin
are
not
likely
based
on
the
RQs
calculated
which
range
(
highest
RQ
=
0.29).

Freshwater
Invertebrates
The
acute
risk
LOC
(
0.5)
and
endangered
species
LOC
(
0.05)
is
exceeded
for
resmethrin
formulated
products.
The
RQ
range
for
freshwater
invertebrates
acutely
exposed
to
resmethrin
in
formulated
products
is
2.81
to
6.48.
The
endangered
species
LOC
(
0.05)
is
slightly
exceeded
for
freshwater
invertebrates
exposed
to
technical
resmethrin
(
RQ
range
=
0.25
to
0.11)
No
chronic
freshwater
invertebrate
data
were
submitted
for
resmethrin.
Chronic
data
from
a
similar
pesticide,
the
pyrethrins,
show
reproductive
effects
in
freshwater
invertebrates
with
a
NOAEC
value
of
0.86
ppb,
which
indicates
that
there
may
be
potential
for
chronic
reproductive
effects
to
aquatic
invertebrates
exposed
to
resmethrin.

Estuarine/
Marine
Invertebrates
The
acute
risk
LOC
(
0.5)
and
endangered
species
LOC
(
0.05)
is
exceeded
for
some
estuarine/
marine
invertebrates
exposed
to
technical
resmethrin.
The
RQ
range
for
acute
risk
to
estuarine/
marine
invertebrates
is
0.25
to
0.58.
RQs
for
estuarine/
marine
invertebrates
exposed
to
formulated
resmethrin
range
from
1.47
to
3.38,
which
indicates
44
potential
acute
risk
and
acute
endangered
species
risk
to
estuarine/
marine
invertebrates.
Chronic
data
from
a
similar
pesticide,
the
pyrethrins,
show
reproductive
effects
in
freshwater
invertebrates
with
a
NOAEC
value
of
0.86
ppb,
which
indicates
that
there
may
be
potential
for
chronic
reproductive
effects
to
aquatic
invertebrates
exposed
to
resmethrin.

Freshwater
Benthic
Organisms
RQs
for
freshwater
benthic
organisms
were
calculated
from
water
column
studies
in
the
absence
of
sediment
toxicity
data
for
resmethrin.
The
acute
risk
LOC
(
0.5)
was
not
exceeded
for
freshwater
benthic
organisms;
however
the
acute
endangered
species
LOC
was
exceeded
for
freshwater
benthic
organisms
in
water
(
RQs
=
0.11).
No
chronic
freshwater
or
estuarine/
marine
benthic
organism
data
were
submitted
to
the
Agency.
However,
based
on
the
potential
for
chronic
risk
to
freshwater
fish
due
to
exposure
to
technical
resmethrin,
chronic
invertebrate
data
from
other
synthetic
pyrethroids,
and
the
affinity
of
resmethrin
to
partition
to
sediment,
there
may
be
potential
for
resmethrin
to
cause
chronic
effects
in
benthic
organisms.

Estuarine/
Marine
Benthic
Organisms
RQs
for
estuarine/
marine
benthic
organisms
were
calculated
from
water
column
studies
in
the
absence
of
sediment
toxicity
data
for
resmethrin.
These
risk
estimates
do
not
exceed
the
acute
risk
LOC
(
0.5)
for
estuarine/
marine
benthic
organisms
exposed
to
technical
resmethrin.
However,
the
acute
endangered
species
LOC
(
0.05
is
exceeded
for
estuarine/
marine
benthic
organisms
in
water
1
foot,
1
meter,
and
2
meters
deep
(
RQs
range
from
0.05
to
0.26).
No
chronic
freshwater
or
estuarine/
marine
benthic
organism
data
were
submitted
to
the
Agency.
However,
based
on
the
potential
for
chronic
risk
to
freshwater
fish
due
to
exposure
to
technical
resmethrin,
chronic
invertebrate
data
from
other
synthetic
pyrethroids,
and
the
affinity
of
resmethrin
to
partition
to
sediment,
there
may
be
potential
for
resmethrin
to
cause
chronic
effects
in
benthic
organisms.

"
Down­
the­
Drain"
Risk
to
Aquatic
Organisms
Acute
and
chronic
RQs
for
freshwater
and
estuarine
fish
and
invertebrates
are
below
0
and
are
therefore
below
the
Agency's
level
of
concern
for
acute
risk
(
0.5)
and
chronic
risk
(
1.0).

iii.
Non­
target
Aquatic
Plants
Exposure,
Toxicity,
and
Risk
No
data
were
submitted
to
evaluate
the
risk
of
resmethrin
exposure
to
non­
target
aquatic
plants.
However,
the
Agency
has
determined
that
resmethrin
will
have
no
effect
on
listed
plants.
Because
of
its
neural
toxic
mode
of
action,
resmethrin
poses
no
phytotoxic
concern.
Also,
no
incident
reports
have
reliably
linked
resmethrin
or
any
other
synthetic
pyrethroid
to
phytotoxic
effects
despite
the
fact
that
pyrethroids
are
often
applied
on
or
near
agricultural
crops.
45
b.
Risk
to
Terrestrial
Organisms
Risks
presented
in
this
section
are
estimates
of
avian
and
mammalian
risk
that
may
occur
due
to
the
wide
area
mosquito
abatement
use
of
resmethrin.
No
other
resmethrin
uses
were
assessed
for
ecological
risk
because
most
uses
are
used
indoors
only,
or
used
on
a
limited
basis
outdoors
by
residential
handlers.

i.
Birds
and
Mammals
Exposure
and
Toxicity
The
Agency
assessed
exposure
to
terrestrial
organisms
by
first
predicting
the
amount
of
resmethrin
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
resmethrin.

Estimated
exposure
concentrations
for
terrestrial
receptors
were
determined
using
the
standard
screening­
level
exposure
model,
Terrestrial
Residue
Exposure
model
(
TREX)
version
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
resmethrin
is
applied.
In
general,
the
underlying
assumption
is
that
most,
if
not
all,
of
the
applied
pesticide
will
settle
in
the
use
area.
However,
because
resmethrin
is
used
as
a
mosquito
adulticide
and
when
applied
is
intended
to
drift,
the
Agency
considered
that
40%
of
resmethrin
settles
within
the
area
treated
and
60%
drifts
away
from
the
treated
area.
Resmethrin
is
applied
as
a
ULV
spray
from
aerial
and
truck­
mounted
sprayers.

EPA's
estimates
of
resmethrin
residues
on
various
wild
animal
food
items
are
summarized
in
table
18.
EPA
used
these
EECs
and
standard
food
consumption
values
to
estimate
dietary
exposure
levels
to
birds
and
mammals
for
resmethrin.
Exposure
modeling
was
done
for
the
mosquito
adulticide
use
with
maximum
and
typical
rates,
application
frequencies,
and
number
of
applications
per
year.

Table
18.
Residue
EECs
on
Avian
and
Mammalian
Food
Items
Scenario
Application
Rate
lb
a.
i./
A
Number
Applications
/
Interval
(
days)
Range
of
EECs
Based
on
Mean
Residues
for:
1)
Short
grass;
2)
Tall
grass;
3)
Broadleaf
plants/
small
insects;
4)
Fruits,
pods,
seeds,
and
large
insects
(
ppm)
Mosquito
Adulticide
Max
rate:
0.007
50
/
3
25
/
3
0.8
(
fruits,
etc.)
 
9.8
(
short
grass)
0.6
(
fruits,
etc.)
 
8.0
(
short
grass)
46
50
/
4
25
/
4
0.6
(
fruits,
etc.)
 
7.6
(
short
grass)
0.5
(
fruits,
etc.)
 
6.7
(
short
grass)
25
/
3
0.3
(
fruits,
etc.)
 
3.9
(
short
grass)
Typical
rate:
0.0035
25
/
4
0.3
(
fruits,
etc.)
 
3.4
(
short
grass)

The
acute
toxicity
of
resmethrin
to
mammals
was
evaluated
using
the
common
laboratory
rat
to
calculate
an
LD50
of
4639
mg
a.
i./
kg.
This
classifies
resmethrin
as
practically
non­
toxic
to
mammals
on
an
acute
basis.
Chronic
studies
in
the
rat
show
that
the
endpoints
most
sensitive
to
resmethrin
exposure
are
reproductive
endpoints
such
as
decreases
in
female
body
weight
gain
during
gestation,
no
weight
gain
during
lactation,
decreased
pup
weight
in
all
generations
and
slight
increases
in
stillborn
pups.

Avian
acute
toxicity
was
measured
using
the
red­
winged
blackbird
to
calculate
an
LD50
value
of
75
mg
ai/
kg
body
weight,
which
classifies
resmethrin
as
moderately
toxic
to
birds
on
an
acute
basis.
A
subacute
dietary
study
was
performed
with
bobwhite
quail
to
determine
an
LC50
for
resmethrin.
The
subacute
dietary
study
with
bobwhite
quail
showed
an
LC50
of
greater
than
5000
ppm.
This
categorizes
resmethrin
as
practically
non­
toxic
to
avian
species
on
a
subacute
dietary
basis.
Chronic
studies
in
the
mallard
duck
show
that
the
endpoint
most
sensitive
to
resmethrin
is
increased
incidence
of
early
embryonic
deaths
in
the
60
ppm
treatment
group.
The
NOAEC
in
the
chronic
mallard
study
was
12
ppm.
Table
19
below
presents
the
acute
and
chronic
toxicity
data
for
terrestrial
organisms
exposed
to
resmethrin.

Table
19.
Summary
of
Acute
and
Chronic
Toxicity
Data
for
Terrestrial
Organisms
Exposed
to
Resmethrin
Acute
Toxicity
Chronic
Toxicity
Species
LD50
(
mg/
kg)
Acute
Oral
Toxicity
(
MRID)
LC50
(
ppm
ai)
Subacute
Dietary
Toxicity
(
MRID)
NOAEC/
LOAEC
(
ppm)
(
MRID)
Affected
Endpoints
Red­
winged
blackbird
Agelaius
phoeniceus
75
Moderately
toxic
(
Acc.#
43653)
­­
­­
­­
­­

Bobwhite
quail
Colinus
virginianus
­­
­­
>
5000
ppm
ai
Practically
non­
toxic
(
41653601)
60.0
/
300.0
(
41465002)
Decrease
of
adult
male
body
weight
Bird
Mallard
duck
Anas
platyrhychos
­­
­­
>
5000
ppm
ai
Practically
non­
toxic
(
41653602)
12.0
/
60.0
(
41465001)
Decrease
in
hatchling
body
weight,
increase
in
embryonic
death
Mammal
Laboratory
rat
Rattus
norvegicus
4639
Practically
non­
toxic
(
42076201)
­­
­­
34.8
/
70.8
(
43189101)
decrease
in
female
body
weight
gain
during
gestation,
no
weight
gain
47
during
lactation,
decreased
pup
weight
in
all
generations
Insect
Honey
bee
Apis
mellifera
0.063
ug
ai/
bee
Highly
toxic
(
VAORES01)
­­
­­
­­
­­

ii.
Birds
and
Mammals
Risk
Risk
quotients
were
calculated
for
both
birds
and
mammals
using
the
dose­
based
and
dietary­
based
toxicity
values.
Generally
dose­
based
RQs
are
higher
than
those
calculated
using
the
dietary­
based
values
because
the
dose­
based
RQs
are
calculated
with
the
assumption
that
birds
or
mammals
will
experience
a
very
short­
term
high
intensity
exposure
from
the
pesticide.
The
dietary­
based
approach
assumes
that
animals
in
the
field
are
consuming
food
at
a
rate
similar
to
that
of
confined
laboratory
animals
despite
the
fact
that
energy
content
in
food
items
differs
between
the
field
and
the
laboratory.
There
are
benefits
and
uncertainties
by
considering
both
methods
which
are
outlined
in
more
detail
in
the
environmental
fate
and
effects
chapter
for
resmethrin.
RQs
calculated
using
both
methods
are
included
in
the
discussion
below.

In
addition,
in
order
to
bound
the
estimates
of
RQs,
mean
Kenega
residue
values
were
calculated
along
with
upper­
bound
values.
Log­
normal
distributions
were
generated
that
describe
residues
levels
on
the
various
food
items.
The
analysis
demonstrates
that
Kenega
values
range
from
about
62­
87
percent
of
the
possible
resmethrin
residues
values,
indicating
that
12
to
38
percent
of
the
higher­
end
food
item
residue
estimates
are
not
captured
in
estimating
exposure
by
using
the
mean
Kenega
values.
For
the
upper­
bound
Kenega
residue
estimates,
about
3­
13
percent
of
the
upperend
residue
estimates
were
not
captured.
Using
the
mean
Kenega
residue
values
for
calculating
RQs
would
not
protect
birds
and
mammals
that
consume
food
items
that
have
residues
on
the
higher
end
of
the
residue
distribution.

A
range
of
RQs
was
calculated
using
dose
and
dietary­
based
toxicity
values
and
mean
or
upper­
bound
Kenega
residue
values.
A
summary
of
the
high­
and
low­
end
RQs
are
outlined
in
the
following
tables;
for
a
complete
list
of
calculated
RQs,
refer
to
Section
4.
A.
2
of
the
environmental
fate
and
effects
assessment
for
resmethrin.

Birds
Using
dose­
based
(
LD50
=
75
mg/
kg­
bw
for
red­
winged
blackbird)
toxicity
values
acute
endangered
species
level
of
concern
was
(
0.1)
exceeded
for
20g
and
100g
birds
that
feed
on
short
grass
(
RQ
range
=
0.13
to
0.17)
when
the
maximum
application
rate
was
used.
Using
the
dietary­
based
toxicity
values
(
LC50
greater
than
5000
mg
ai/
kg
diet
for
mallard
duck),
no
LOCs
are
exceeded
for
any
scenario.
The
acute
dietary
RQs
are
listed
in
table
20
below.

Table
20.
Dose­
based
acute
RQs
for
birds
(
red­
winged
blackbird)
exposed
to
resmethrin
based
on
mean
residues,
maximum
application
rate
(
0.007
lb
ai/
acre),
maximum
number
of
48
applications
(
50),
and
minimum
application
interval
(
3
days)
Short
Grass
Tall
Grass
Broadleaf
Plants
/
Small
Insects
Fruits/
Pods/
Seeds/
Large
Insects
Number
of
applications/
Application
interval
Body
Weight
Avian
Acute
Risk
Quotients
20
0.17
1
0.07
0.09
0.01
100
0.13
1
0.06
0.07
0.01
50
/
3
1000
0.04
0.02
0.2
0.003
Dietary­
based
acute
RQs
for
birds
(
mallard
duck)
exposed
to
resmethrin
based
on
mean
residues,
maximum
application
rate
(
0.007
lb
ai/
acre),
maximum
number
of
applications
(
50),
and
minimum
application
interval
(
3
days)
50
/
3
0.002
0.001
0.001
0.0002
1
RQ
exceeds
LOC
for
acute
endangered
species
(>
0.1)

Chronic
RQs
are
calculated
using
mean
Kenaga
residue
values
and
a
chronic
NOAEC
(
12
mg
ai/
kg
diet)
from
the
dietary
study
in
mallard
duck.
LOCs
are
not
exceeded
for
birds
that
consume
short
grass,
tall
grass,
and
broadleaf
plants/
small
insects
when
maximum
application
rates
are
used.
See
table
21
below
for
a
summary
of
RQs.

Table
21.
Dietary­
based
chronic
RQs
for
birds
exposed
to
resmethrin
based
on
mean
residue
levels,
maximum
application
rate
(
0.007
lb
ai/
acre),
maximum
number
of
applications
(
50),
and
minimum
application
interval
(
3
days).
Number
of
applications/
Application
interval
Short
Grass
Tall
Grass
Broadleaf
Plants
/
Small
Insects
Fruits/
Pods/
Seeds/
Large
Insects
50
/
3
0.82
0.35
0.43
0.07
Mammals
Acute
mammalian
risks
were
calculated
using
the
acute
oral
LD50
of
4639
mg
ai/
kg
body
weight
from
a
rat
study,
and
chronic
mammalian
risks
were
calculated
using
a
chronic
NOAEL
of
34.8
mg
ai/
kg
body
weight
in
rats.
Chronic
RQs
were
calculated
using
upper­
bound
Kenaga
residue
values
and
dose­
based
toxicity
values.
All
acute
RQs
are
below
the
LOCs
for
acute
risk
and
acute
endangered
species
risk.
All
chronic
RQs
are
below
the
LOCs
for
chronic
risk.
Therefore,
resmethrin
is
not
likely
to
pose
an
acute
or
chronic
risk
to
mammals.

iii.
Non­
Target
Terrestrial
Plant
Toxicity,
Exposure,
and
Risk
No
data
were
submitted
to
evaluate
the
risk
of
resmethrin
exposure
to
non­
target
terrestrial
plants.
However,
the
Agency
has
determined
that
resmethrin
will
have
no
effect
on
listed
plants.
Because
of
its
neural
toxic
mode
of
action,
resmethrin
poses
no
phytotoxic
concern.
Also,
no
incident
reports
have
reliably
linked
resmethrin
or
any
other
synthetic
pyrethroid
to
phytotoxic
effects
despite
the
fact
that
pyrethroids
are
often
applied
on
or
near
agricultural
crops.
49
iv.
Non­
Target
Insect
Risk
Currently,
the
Agency
does
not
estimate
RQs
for
terrestrial
non­
target
insects.
However,
based
on
a
single
contact
study
in
honey
bees,
technical
resmethrin
is
classified
as
highly
toxic
on
an
acute
contact
basis
to
non­
target
terrestrial
insects
(
LD50
=
0.063
ug/
ai
per
bee).
Concern
for
acute
toxicity
to
non­
target
insects
is
high
when
they
are
exposed
directly
to
resmethrin.
A
label
statement
addressing
this
concern
is
required
for
all
resmethrin
occupational
outdoor
use
products
and
wide
area
mosquito
abatement
products.

3.
Ecological
Incidents
A
total
of
three
incidents
involving
aquatic
resmethrin
exposure
have
been
reported
to
EPA
involving
aquatic
organisms
allegedly
exposed
to
resmethrin
via
spray
drift.
The
organisms
exposed
in
these
incidents
include
blue
claw
crabs,
goldfish,
fish
(
general),
and
shrimp
(
general).
Since
no
information
regarding
application
rate,
residue
analysis,
or
time
of
event
relative
to
application
was
provided,
the
strength
of
these
incidents
as
an
additional
line
of
evidence
is
uncertain.

A
total
of
four
incidents
involving
terrestrial
resmethrin
exposure
have
been
reported
to
EPA.
The
organisms
exposed
in
these
incidents
include
bees,
ornamental
plants,
and
corn.
No
information
regarding
application
rate,
residue
analysis,
or
time
of
event
relative
to
application
was
provided
for
any
of
these
terrestrial
incidents.
In
addition,
the
neurotoxic
mode
of
action
of
resmethrin
does
not
cause
concern
for
phytotoxic
effects.
The
strength
of
these
incidents
involving
exposure
of
terrestrial
plants
as
evidence
of
phytotoxic
effects
is
highly
uncertain.

4.
Endangered
Species
Concerns
The
Agency's
screening
level
risk
assessment
indicates
that
uses
of
resmethrin
will
have
no
direct
acute
or
chronic
effects
on
aquatic
or
terrestrial
plants.
The
Agency
has
determined
that
resmethrin
will
have
no
effect
on
listed
terrestrial
or
aquatic
plants.
There
are
potential
indirect
effects
to
any
listed
species
dependent
on
a
species
that
is
affected
by
the
use
of
resmethrin.
For
the
screening
level
assessment,
potential
risks
to
reptiles
and
terrestrial
phase
amphibians
are
estimated
based
on
risks
to
birds;
and
potential
risks
to
aquatic
phase
amphibians
are
estimated
based
on
risks
to
freshwater
fish.
Because
the
screening
level
assessment
shows
potential
risks
for
both
birds
and
freshwater
fish,
the
potential
risks
to
reptiles,
terrestrial
phase
amphibians,
and
aquatic
phase
amphibians
cannot
be
precluded
based
on
the
screening
level
assessment.

A
preliminary
analysis
of
the
co­
occurrence
of
listed
species
and
proposed
reregistration
of
resmethrin
uses
was
conducted
using
the
Agency's
LOCATES
database.
In
general,
for
all
labeled
uses
of
resmethrin
there
is
at
least
one,
and
usually
more,
listed
species
that
may
potentially
occur
in
or
near
a
use
area.
This
preliminary
analysis
50
indicates
that
there
is
a
potential
for
resmethrin
use
to
overlap
with
listed
species
and
that
a
more
refined
assessment
is
warranted.

The
Endangered
Species
Act
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
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,
as
appropriate,
that
address
these
impacts.
In
general,
to
assess
the
potential
of
registered
pesticide
uses
that
may
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
species­
specific
analysis
will
take
into
consideration
any
regulatory
changes
recommended
in
this
RED
that
have
been
implemented
at
that
time.
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
resmethrin,
other
measures
to
mitigate
any
potential
impace,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.

The
ecological
assessment
that
EPA
conducted
for
this
RED
does
not,
in
itself,
constitute
a
determination
as
to
whether
specific
species
or
critical
habitat
may
be
harmed
by
resmethrin.
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
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
specific
assessments
for
resmethrin
result
in
the
need
to
modify
use
of
the
pesticide,
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
resmethrin
at
levels
of
concern.
51
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
resmethrin.
The
Agency
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
resmethrin.

The
Agency
has
completed
its
assessment
of
the
dietary,
occupational
and
ecological
risk
associated
with
the
use
of
resmethrin
apart
from
a
species
specific
Endangered
Species
assessment
as
discussed
above.
Based
on
this
assessment,
the
Agency
has
sufficient
information
on
resmethrin
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
resmethrin­
containing
products
are
eligible
for
reregistration
provided
that
label
amendments
are
made
as
outlined
in
this
RED.
Appendix
A
summarizes
the
uses
of
resmethrin
that
are
eligible
for
reregistration.
Appendix
B
identifies
the
generic
data
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
resmethrin,
the
Agency
has
determined
that
resmethrin
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
resmethrin.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
resmethrin
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.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
resmethrin.
EPA
has
determined
that
risk
from
dietary
(
food
+
water)
exposure
is
within
its
own
"
risk
cup."
An
aggregate
assessment
was
conducted
for
resmethrin
for
exposures
through
dietary
(
food
+
water)
and
residential
(
indoor
and
outdoor)
pathways.
The
Agency
has
determined
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels.
In
other
words,
EPA
has
concluded
that
the
tolerances
for
resmethrin
meet
FQPA
safety
standards.
In
reaching
this
52
determination,
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
aggregate
exposure
from
food,
drinking
water,
and
residential
sources.

b.
Determination
of
Safety
to
U.
S.
Population
The
Agency
has
determined
that
the
established
tolerance
for
resmethrin,
with
amendments
and
changes
as
specified
in
this
document,
meets
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
major
identifiable
subgroup
from
the
use
of
resmethrin.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices,
and
the
environmental
behavior
of
resmethrin.
As
discussed
in
Section
III,
aggregate
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
tolerance
for
resmethrin,
with
amendments
and
changes
as
specified
in
this
document,
meets
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
and
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
resmethrin
residues
in
this
population
subgroup.
In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
exposure
to
residues
of
resmethrin,
the
Agency
considered
the
completeness
of
the
hazard
database
for
developmental
and
reproductive
effects,
the
nature
of
the
effects
observed,
and
other
information.
The
FQPA
Safety
Factor
has
been
retained
at
10X.
There
are
no
residual
uncertainties
for
pre­
and/
or
post­
natal
toxicity,
exposure
is
not
underestimated,
and
there
is
no
evidence
of
increased
susceptibility.
However,
an
FQPA
safety
factor
due
to
database
uncertainty
is
retained
at
10X
to
account
for
lack
of
a
developmental
neurotoxicity
study.

2.
Endocrine
Disruptor
Effects
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
53
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
resmethrin
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,
resmethrin
may
be
subject
to
additional
screening
and/
or
testing.

3.
Cumulative
Risks
Resmethrin
is
a
member
of
the
pyrethroid
class
of
pesticides.
Although
all
pyrethroids
alter
nerve
function
by
modifying
the
normal
biochemistry
and
physiology
of
nerve
membrane
sodium
channels,
EPA
is
not
currently
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
pyrethroids.
Although
all
pyrethroids
because
there
are
multiple
types
of
sodium
channels,
and
it
is
currently
unknown
whether
all
pyrethroids
have
similar
effects
on
all
channels.
In
addition,
the
Agency
does
not
have
a
clear
understanding
of
effects
on
key
downstream
neuronal
function,
e.
g.,
nerve
excitability,
nor
do
we
understand
how
these
key
events
interact
to
produce
their
compound­
specific
patterns
of
neurotoxicity.
There
is
ongoing
research
by
both
EPA's
Office
of
Research
and
Development
and
the
pyrethroid
registrants
to
evaluate
the
differential
biochemical
and
physiological
actions
of
pyrethroids
in
mammals.
This
research
is
expected
to
be
completed
by
2007.
When
the
results
of
this
research
are
available,
the
Agency
will
make
a
determination
of
common
mechanism
of
toxicity
as
a
basis
for
assessing
cumulative
risk.
For
information
regarding
EPA's
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
of
toxicity,
see
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

C.
Tolerance
Reassessment
Summary
Table
23.
Tolerance
Reassessment
Summary
for
Resmethrin
(
40
CFR
§
180.525)
Commodity
Current
Tolerance
(
ppm)
Range
of
Residues
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/[
Correct
Commodity
Definition]

Food
items
3.0
<
0.003­
0.377
1
To
be
determined
Additional
information/
data
are
required
to
upgrade
the
existing
study
supporting
the
use
of
resmethrin
as
a
crack
and
crevice
treatment,
and
new
studies
are
required
supporting
space
treatment
uses
in
food
and
feed
handling
establishments.
1
Resmethrin
residues
in/
on
representative
food
commodities
following
crack
and
crevice
treatment
to
representative
types
of
food
handling
establishments.

There
are
no
dietary
or
aggregate
risk
concerns
associated
with
the
current
tolerance
and
EPA
considers
it
reassessed
at
the
current
tolerance
level.
However,
additional
data
are
necessary
to
confirm
this
tolerance
level
is
appropriate
for
resmethrin.
54
There
are
currently
no
Codex
or
Canadian
MRLs
for
resmethrin.

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

1.
Human
Health
Risk
a.
Dietary
(
Food
+
Drinking
Water)
Risk
Non­
Cancer
Dietary
Risk
There
are
no
resmethrin
non­
cancer
dietary
(
food
+
drinking
water)
risks
that
exceed
the
Agency's
level
of
concern.
This
assessment
is
protective
of
the
general
U.
S.
population
and
all
population
subgroups,
including
infants
and
children.
Therefore,
no
mitigation
is
necessary
for
these
scenarios.

Cancer
Dietary
Risk
A
slightly
refined
cancer
dietary
risk
assessment
was
conducted
for
all
supported
resmethrin
food
uses.
When
both
detections
and
non­
detections
are
included
in
the
resmethrin
cancer
dietary
analysis,
and
the
percentage
of
food
handling
establishment
treated
is
conservatively
estimated
to
be
10%,
dietary
and
drinking
water
risks
are
not
of
concern
to
the
Agency
(
lifetime
dietary
cancer
risk
for
the
general
U.
S.
population
is
1.6
x
10­
6).
Food
risks
are
only
slightly
refined,
which
results
in
high­
end
estimates
of
exposures
to
residues
in
food.
Additionally,
the
LOD
was
used
as
the
residue
value
for
all
non­
detections
in
a
crack
and
crevice
residue
study
with
resmethrin.
This
also
is
an
overestimation
of
exposure.
Drinking
water
exposure
estimates
were
developed
using
the
tier
2
model
PRZM­
EXAMs,
which
also
results
in
high­
end
estimates
of
potential
exposure
to
resmethrin.
No
mitigation
is
necessary
for
this
scenario.

b.
Residential
Risk
Non­
Cancer
Residential
Risk
Most
estimates
for
residential
risk
are
below
EPA's
level
of
concern.
All
residential
risks
are
below
the
Agency's
level
of
concern
(
MOEs
are
above
1000),
except
for
post­
application
risk
for
a
child
exposed
to
indoor
aerosol
space
sprays.

The
non­
cancer
post­
application
inhalation
risk
estimate
for
a
child
exposed
to
an
indoor
aerosol
space
spray
exceeds
the
Agency's
level
of
concern
with
an
MOE
of
900.
For
the
non­
cancer
post­
application
inhalation
risk
estimate,
the
Agency
assumed
that
one
16
oz
spray
can
containing
0.2%
ai
was
used
per
application.
This
exposure
may
occur
when
a
child
enters
a
room
within
10
minutes
after
a
resmethrin
indoor
aerosol
space
spray
application.
Potential
risk
is
below
the
Agency's
level
of
concern
if
a
child
55
waits
2
hours
before
entering
a
room
where
resmethrin
has
been
applied
as
an
indoor
aerosol
space
spray.
In
order
to
mitigate
this
inhalation
risk,
resmethrin
products
applied
as
indoor
aerosol
space
sprays
must
be
labeled
to
instruct
users
to
keep
all
people
and
pets
out
of
sprayed
rooms
for
2
hours
after
application.
When
residents
stay
out
of
sprayed
rooms
for
2
hours,
the
post­
application
MOE
for
a
child
is
3500
which
is
below
the
Agency's
level
of
concern
for
residential
exposure.
No
additional
mitigation
is
needed
for
this
scenario.

Cancer
Residential
Risk
There
are
no
residential
cancer
risks
of
concern
when
resmethrin
is
handled
by
residents
or
applied
to
residential
areas.
Residential
handler
risk,
bystander
risk,
and
residential
post­
application
risk
are
below
the
Agency's
level
of
concern
for
all
scenarios.
Additionally,
the
residential
handler
scenario
with
the
highest
exposure
and
risk
(
indoor
aerosol
space
spray)
was
assumed
to
occur
three
times
a
year
for
70
years.
No
mitigation
is
necessary
for
these
scenarios.

c.
Aggregate
(
Food
+
Drinking
Water
+
Residential)
Risk
Non­
Cancer
Aggregate
Risk
Non­
cancer
residential
risks
cannot
be
aggregated
with
the
resmethrin
non­
cancer
assessment
for
food
and
drinking
water
because
the
toxicity
endpoints
for
residential
dietary,
incidental
oral,
dermal,
and
inhalation
exposures
are
not
based
on
common
effects.
Therefore,
no
non­
cancer
aggregate
risk
assessment
was
conducted
for
resmethrin,
other
than
the
previously
described
aggregate
assessment
of
food
and
drinking
water.

Cancer
Aggregate
Risk
For
the
cancer
aggregate
risk
analysis,
a
slightly
refined
dietary
assessment
was
combined
with
the
residential
cancer
risk
scenario
with
the
highest
exposure
and
risk
(
residential
indoor
aerosol
spray
application).
The
slightly
refined
dietary
assessment
risk
estimate
was
1.6
x
10­
6,
and
the
residential
indoor
aerosol
spray
application
risk
estimate
was
1.0
x
10­
6
when
residents
wait
2
hours
before
re­
entering
the
space
that
was
sprayed.
The
residential
exposure
scenario
which
was
aggregated
with
dietary
risks
is
the
one
with
the
highest
estimated
exposure
and
risk
(
indoor
aerosol
space
spray)
of
all
the
residential
scenarios
assessed.
EPA
believes
the
estimated
risks
for
each
pathway
of
exposure
(
food,
drinking
water,
and
residential)
are
greater
than
what
people
are
likely
to
experience,
and
the
probability
of
people
experiencing
all
these
high­
end
exposures
together
over
the
course
of
a
lifetime
is
low.
When
these
scenarios
are
combined,
the
aggregate
cancer
risk
estimate
is
2.6
x
10­
6,
which
is
within
an
acceptable
range.

Because
the
residential
indoor
aerosol
spray
application
risk
estimate
is
dependant
upon
residents
not
entering
sprayed
spaces
for
2
hours
after
application,
a
statement
must
be
placed
on
aerosol
space
spray
residential
labels
indicating
that
residents
must
not
enter
fogged
spaces
for
2
hours
after
application.
A
ventilation
requirement
will
also
be
required
on
labels
indicating
that
residents
must
ventilate
the
sprayed
space
for
10
minutes
with
fresh
air
before
occupying
the
room.
Similar
label
requirements
must
also
56
be
placed
on
labels
of
products
used
by
pest
control
operators
(
PCOs)
that
they
must
inform
residents
to
not
enter
sprayed
spaces
for
4
hours
and
ventilate
for
20­
120
minutes
depending
on
the
size
of
the
treated
area
before
occupying
the
sprayed
space.
No
additional
mitigation
is
necessary
for
these
scenarios.

d.
Occupational
Risk
Non­
Cancer
Occupational
Risk
Concerns
for
workers
mixing,
loading,
and
applying
the
liquid
formulations
of
resmethrin
can
be
mitigated
with
PPE.
All
mixers,
loaders,
and
appliers
using
liquid
formulations
of
resmethrin
are
required
to
wear
gloves
for
dermal
protection.
In
addition,
workers
using
foggers
in
indoor
spaces
are
required
to
wear
respirators
for
protection
against
potential
inhalation
risk
and
coveralls
for
protection
against
potential
dermal
risk.
All
applicators
and
other
handlers
using
ready­
to­
use
aerosol
formulations
will
be
required
to
wear
gloves.
For
products
intended
only
for
wide
area
mosquito
abatement
programs,
chemical­
resistant
gloves
are
required
for
all
handlers
except
applicators.

Cancer
Occupational
Risk
There
are
some
concerns
for
workers
when
mixing,
loading,
and
applying
the
liquid
formulations
of
resmethrin.
All
mixers,
loaders,
and
appliers
using
liquid
formulations
of
resmethrin
are
required
to
wear
gloves
for
dermal
protection.
In
addition,
workers
using
foggers
in
indoor
spaces
are
required
to
wear
respirators
for
protection
against
potential
inhalation
risk
and
coveralls
for
protection
against
potential
dermal
risk.
All
applicators
and
other
handlers
using
ready­
to­
use
aerosol
formulations
will
be
required
to
wear
gloves.
For
products
intended
only
for
wide
area
mosquito
abatement
programs,
chemical­
resistant
gloves
are
required
for
all
handlers
except
applicators.

Exposure
Reduction
The
Agency
incident
report
recommends
appropriate
respiratory
protective
equipment
for
individuals
who
are
likely
to
have
substantial
contact
with
resmethrin.
Because
mosquito
abatement
handlers
may
be
exposed
to
resmethrin
on
a
regular
basis,
enclosed
cabs
are
required
for
ULV
truck­
mounted
mosquito
abatement
spray
applications,
and
enclosed
cockpits
are
required
for
ULV
aerial
mosquito
abatement
spray
applications.
Additionally,
as
mentioned
above,
workers
using
foggers
in
indoor
spaces
must
wear
respirators
for
protection
from
inhalation
risk
and
coveralls
for
protection
from
dermal
risk.

A
12­
hour
REI
is
required
for
workers
re­
entering
treated
greenhouses
after
resmethrin
applications.
In
addition,
workers
who
enter
a
resmethrin­
treated
greenhouse
before
the
REI
has
expired
must
wear
coveralls
over
long­
sleeve
shirt
and
long
pants,
chemical­
resistant
gloves
made
of
any
waterproof
material,
and
shoes
plus
socks.

2.
Environmental
Risk
The
Agency
has
conducted
a
screening­
level
ecological
risk
assessment
for
the
mosquito
control
use
of
resmethrin
based
on
application
of
resmethrin
to
Florida
turf.
57
Based
on
the
available
data,
the
Agency
has
identified
potential
acute
and
chronic
risks
of
concern
to
freshwater
fish,
potential
acute
risks
estuarine/
marine
fish,
acute
risks
and
potential
chronic
risks
to
freshwater
and
estuarine/
marine
invertebrates,
and
freshwater
and
estuarine/
marine
benthic
organisms.
Available
data
show
potential
acute
and
chronic
risks
to
birds
when
a
dose­
based
study
is
used.
When
a
dietary­
based
study
is
used,
acute
and
chronic
risks
to
birds
are
considered
not
likely.
There
are
no
acute
or
chronic
effects
to
mammals,
aquatic
plants,
or
terrestrial
plants
exposed
to
resmethrin
when
it
is
applied
as
a
wide
area
mosquito
abatement
spray
as
modeled
in
the
environmental
fate
and
effects
assessment.

While
there
are
slight
estimated
exceedances
of
the
LOCs
for
some
terrestrial
and
aquatic
species,
based
on
its
use
pattern
and
usage
information
the
ecological
risks
associated
with
resmethrin
are
expected
to
be
limited.
Resmethrin
is
used
for
wide
area
ULV
mosquito
abatement,
in
and
around
homes,
commercial
establishments,
industrial
areas,
and
food
handling
establishments
to
treat
flying
and
crawling
insects,
and
by
pet
groomers,
veterinarians,
and
citizens
for
insect
control
on
livestock
and
pets.
Resmethrin
use
is
estimated
at
50,000
lbs
per
year,
with
over
half
of
those
pounds
applied
per
year
used
for
mosquito
control.

Release­
height
restrictions
on
resmethrin
aerial
mosquitocide
applications
will
reduce
wildlife
exposure.
RQs
were
estimated
with
a
25
foot
aerial
boom
height.
The
resmethrin
registrants
have
agreed
to
nozzle
heights
of
no
less
than
100
feet
above
ground
or
canopy
for
fixed
wing
applicators
and
no
less
than
75
feet
above
ground
or
canopy
for
rotary
wing
applicators.
The
higher
release
heights
will
reduce
wildlife
exposure
to
resmethrin.

The
registrants
for
resmethrin
have
also
agreed
to
set
new
application
rates
for
resmethrin.
Previously,
resmethrin
labels
had
often
not
specified
application
rates.
The
rates
listed
below
will
serve
as
maximum
application
rates
for
reregistered
resmethrin
products.

 
Products
labeled
for
use
on
Livestock,
Farm
Animals,
and
Pets
(
Direct
Application):
Product
must
contain
0.35%
ai.
or
less.

 
Products
labeled
for
use
in
Outdoor
Sites
(
Commercial,
Recreational,
Domestic
Outdoor
Sites,
Agricultural
Structures,
Agricultural
Premises,
and
Agricultural
Equipment):
0.25
lb
ai
per
acre.

 
Products
labeled
for
use
in
Space
Applications
(
Indoor
Food
Handling/
Processing/
Eating
Establishments;
Commercial
Structure
Premises
and
Equipment;
Domestic
Structure
Premises
and
Equipment):
0.001
lb
ai
per
1000
ft2.

 
Products
labeled
for
use
in
Surface
Crack
and
Crevice
Application
(
Indoor
Food
Handling/
Processing/
Eating
Establishments;
Commercial
Structure
Premises
and
Equipment;
Domestic
Structure
Premises
and
Equipment):
0.242
lb
ai
per
1000
ft2.

Additionally,
wide
area
mosquito
control
products
must
contain
the
following
requirements:
58
 
Products
labeled
for
wide
area
mosquito
abatement
must
state
a
maximum
application
rate
of
0.007
lb
ai/
acre,
and
state
a
maximum
yearly
application
limit
of
0.2
lb
ai/
acre.
 
Release
height
requirement
for
rotary
wing
of
no
less
than
75
feet
above
the
ground
or
canopy,
for
fixed
wing
of
no
less
than
100
feet
above
the
ground
or
canopy.
 
Must
contain
environmental
hazard
statements
informing
user
of
toxicity
to
fish,
aquatic
invertebrates,
and
oysters/
shrimp.
 
Must
contain
a
statement
informing
user
of
toxicity
to
bees
visiting
treated
area.
 
Must
be
in
compliance
with
EPA
PR
Notice
2005­
1.

Stewardship
Language
The
Agency
cannot
currently
fully
assess
the
potential
risks
to
aquatic
organisms
from
resmethrin
use
around
the
home.
Therefore
to
lessen
potential
risks
the
Agency
is
seeking
to
reduce
the
drift
and
run­
off
of
resmethrin
into
aquatic
habits
through
explicit
directions
for
use
on
both
professional
and
consumer­
use
products
for
use
in
residential
settings.
These
use
directions
include
best
management
and
stewardship
practices
which
are
formulation
specific,
and
will
serve
to
reduce
the
potential
run­
off
and
drift
that
can
occur
from
applications
of
these
products.
Label
statements
implementing
these
measures
are
listed
in
the
Label
Changes
Summary
Table
in
Section
V
of
this
RED
document.

a.
Fish
and
Aquatic
Invertebrate
Risk
The
following
summary
of
ecological
concerns
does
not
reflect
all
of
the
mitigation
measures
mentioned
above.
Thus,
the
actual
exposure
to
resmethrin
will
be
less
for
all
non­
target
species
than
current
estimates
reflect.

Acute
and
Chronic
Freshwater
and
Estuarine/
Marine
Fish
For
freshwater
fish,
the
highest
acute
RQ
value
is
2.8
for
freshwater
fish
in
water
2
meters
deep.
This
exceeds
the
acute
risk
LOC
of
0.5
and
the
acute
endangered
species
LOC
of
0.05
and
is
of
concern.
The
RQ
decreases
in
shallow
water
because
resmethrin
is
broken
down
through
aqueous
photolysis,
and
more
light
is
available
in
shallow
water.
The
RQ
value
for
chronic
risk
to
freshwater
fish
is
1.7
for
fish
exposed
to
the
TGAI
in
a
water
body
2
meters
deep
at
a
3
day
application
interval.
This
exceeds
the
chronic
risk
LOC
of
1.
When
a
release
height
of
75
feet
for
aerial
applications
is
considered,
the
RQs
for
freshwater
fish
decrease
to
an
acute
RQ
of
0.75
and
a
chronic
RQ
of
0.51.
Thus,
when
the
release
height
of
75
feet
is
considered,
the
acute
risk
level
is
still
of
concern,
but
the
freshwater
chronic
risk
level
is
no
longer
of
concern.

For
estuarine/
marine
fish,
the
RQ
value
does
not
exceed
the
acute
risk
LOC
(
0.5).
However,
the
acute
endangered
species
LOC
(
0.05)
is
exceeded
for
estuarine/
marine
fish
(
estimated
value
of
0.48
for
formulated
resmethrin).
When
a
release
height
of
75
feet
for
aerial
applications
is
considered,
the
acute
RQ
decreases
to
0.13,
which
is
still
above
the
acute
endangered
species
LOC.
Chronic
risks
of
concern
for
estuarine/
marine
fish
are
not
likely
(
RQs
range
from
0.02
to
0.29,
therefore
less
than
the
chronic
LOC
of
1).
59
Acute
and
Chronic
Freshwater
and
Estuarine/
Marine
Invertebrates
For
freshwater
invertebrates,
the
acute
RQ
value
exceeds
the
acute
risk
LOC
(
0.5)
and
acute
endangered
species
LOC
(
0.05)
for
resmethrin
formulated
products
with
an
estimated
RQ
value
of
6.5.
When
a
release
height
of
75
feet
is
considered
for
aerial
applications,
the
acute
RQ
decreases
to
1.74,
which
is
still
above
the
acute
risk
and
acute
endangered
species
LOCs.
Chronic
resmethrin
exposure
to
freshwater
invertebrate
data
was
not
available,
but
chronic
data
from
a
similar
pesticide,
the
pyrethrins,
shows
reproductive
effects
in
freshwater
invertebrates
with
a
NOAEC
value
of
0.86
ppb.
This
may
indicate
potential
chronic
risk
for
freshwater
invertebrates
exposed
to
resmethrin.

For
estuarine/
marine
invertebrates,
the
maximum
acute
RQ
value
exceeds
the
acute
risk
LOC
(
0.5)
and
acute
endangered
species
LOC
(
0.05)
at
3.4
when
estuarine/
marine
invertebrates
are
exposed
to
formulated
resmethrin.
When
a
release
height
of
75
feet
is
considered
for
aerial
applications,
the
acute
RQ
decreases
to
0.91,
which
is
a
level
that
still
exceeds
the
acute
risk
and
acute
endangered
species
LOCs.
Chronic
resmethrin
exposure
to
esturarine/
marine
invertebrates
data
was
not
available,
but
chronic
data
from
a
similar
pesticide,
the
pyrethrins,
shows
reproductive
effects
in
freshwater
invertebrates
with
a
NOAEC
value
of
0.86
ppb.
This
may
indicate
potential
chronic
risk
for
estuarine/
marine
invertebrates
exposed
to
resmethrin.

Acute
and
Chronic
Freshwater
and
Estuarine/
Marine
Benthic
Organisms
RQs
for
freshwater
benthic
organisms
were
calculated
from
water
column
studies
in
the
absence
of
sediment
toxicity
data
for
resmethrin.
The
maximum
acute
RQ
value
does
not
exceed
the
acute
risk
LOC
(
0.5)
at
0.11
for
technical
resmethrin,
however
this
level
does
exceed
the
acute
endangered
species
LOC
of
0.05.
Registrants
have
agreed
to
a
release
height
of
75
for
aerial
mosquito
applications.
When
this
is
taken
into
account
for
aerial
applications,
the
RQ
decreases
to
0.03,
which
is
below
the
acute
endangered
species
LOC
of
0.05.
Therefore,
acute
risk
is
not
likely
to
be
of
concern
for
freshwater
benthic
organisms
exposed
to
resmethrin.
No
chronic
freshwater
or
estuarine/
marine
benthic
organism
data
were
submitted
to
the
Agency.
However,
based
on
the
potential
for
chronic
risk
to
freshwater
fish
due
to
exposure
to
technical
resmethrin,
chronic
invertebrate
data
from
other
synthetic
pyrethroids,
and
the
affinity
of
resmethrin
to
partition
to
sediment,
there
is
potential
for
resmethrin
to
cause
chronic
effects
in
benthic
organisms.

RQs
for
estuarine/
marine
benthic
organisms
were
calculated
from
water
column
studies
in
the
absence
of
sediment
toxicity
data
for
resmethrin.
The
maximum
acute
RQ
value
does
not
exceed
the
acute
risk
LOC
(
0.5)
at
0.26
for
technical
resmethrin.
However,
the
acute
RQ
does
exceed
the
acute
endangered
species
LOC
0.05.
When
a
release
height
of
75
feet
is
considered
for
aerial
applications,
the
acute
RQ
decreases
to
0.08,
which
is
still
slightly
above
the
acute
endangered
species
level
of
concern.
No
chronic
freshwater
or
estuarine/
marine
benthic
organism
data
were
submitted
to
the
Agency.
However,
based
on
the
potential
for
chronic
risk
to
freshwater
fish
due
to
exposure
to
technical
resmethrin,
chronic
invertebrate
data
from
other
synthetic
60
pyrethroids,
and
the
affinity
of
resmethrin
to
partition
to
sediment,
there
is
potential
for
resmethrin
to
cause
chronic
effects
in
benthic
organisms.

Aquatic
Plants
No
aquatic
vascular
or
non­
vascular
data
plant
data
were
submitted
for
resmethrin.
However,
the
Agency
has
determined
that
resmethrin
will
have
no
effect
on
listed
plants.
It
is
unlikely
that
resmethrin
poses
a
phytotoxic
concern
based
on
its
neurotoxic
mode
of
action,
lack
of
toxic
effects
when
plants
are
exposed
to
other
pyrethroids,
and
lack
of
ecological
incident
reports
for
plants.

"
Down­
the­
Drain"
Assessment
Acute
and
chronic
RQs
for
freshwater
and
estuarine
fish
and
invertebrates
are
below
0
and
are
therefore
below
the
Agency's
level
of
concern
for
acute
risk
(
0.5)
and
chronic
risk
(
1.0).
Therefore,
no
mitigation
is
necessary
at
this
time
to
address
resmethrin
risk
to
aquatic
organisms
around
wastewater
plant
releases.

b.
Avian
Risk
Terrestrial
Birds
When
mean
residues
are
considered,
the
acute
use
LOC
(
0.5)
is
not
exceeded
for
birds
that
feed
on
short
grass,
tall
grass,
and
broadleaf
plants/
small
insects
when
RQs
are
calculated
with
a
dose­
based
red­
winged
blackbird
study.
The
acute
endangered
species
LOC
of
0.1
is
exceeded
for
20g
and
100g
birds
feed
on
short
grass.
The
chronic
LOC
(
1)
is
not
exceeded
for
birds
feeding
on
short
grass,
tall
grass,
and
broadleaf
plants/
small
insects
when
the
dose­
based
study
is
used.
The
highest
chronic
RQ
considering
mean
residues
is
0.8.

When
avian
RQs
are
calculated
with
dietary­
based
toxicity
values,
no
LOCs
are
exceeded
for
any
acute
or
chronic
scenario.

c.
Mammalian
Risk
Terrestrial
Mammals
All
acute
and
chronic
RQs
are
below
the
respective
acute
and
chronic
LOCs
for
mammalian
risk.
Therefore,
resmethrin
is
not
likely
to
pose
an
acute
or
chronic
risk
to
mammals.

d.
Terrestrial
Plant
Risk
No
terrestrial
plant
data
were
submitted
to
the
Agency
for
resmethrin.
However,
the
Agency
has
determined
that
resmethrin
will
have
no
effect
on
listed
plants.
It
is
unlikely
that
resmethrin
poses
a
phytotoxic
concern
based
on
its
neurotoxic
mode
of
action,
lack
of
toxic
effects
when
plants
are
exposed
to
other
pyrethroids,
and
lack
of
ecological
incident
reports
for
plants.

e.
Non­
Target
Insect
Risk
61
Currently,
the
Agency
does
not
estimate
RQs
for
terrestrial
non­
target
insects.
However,
based
on
a
single
study
in
honey
bees,
technical
resmethrin
is
classified
as
highly
toxic
on
an
acute
contact
basis
to
non­
target
terrestrial
insects
(
LD50
=
0.063
ug/
ai
per
bee).
Label
statements
addressing
bee
risk
are
required
for
all
resmethrin
occupational
and
wide
area
mosquito
abatement
products
used
outdoors.

3.
Ongoing
Work
on
Pyrethoids
One
of
the
risk
assessment
goals
of
the
Office
of
Pesticide
Programs
(
OPP)
is
to
estimate
pesticide
exposure
through
all
significant
routes
of
exposure
from
both
agricultural
and
non­
crop
uses.
However,
the
ecological
risk
assessments
for
most
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
pyrethroids
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
insect
control,
and
treatment
of
pets
and
clothing.

The
Agency
uses
a
"
down­
the­
drain"
model
to
perform
a
screening­
level
aquatic
risk
assessment
for
indoor
uses
of
pesticides.
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.
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,
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.
62
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
column.
The
USGS
NAWQA
program
included
permethrin
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
63
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.
Resmethrin
was
not
detected
in
the
USGS
NAWQA
survey.

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
permethrin
and
cypermethrin,
which
are
currently
in
the
reregistration
process),
as
well
as
for
other
insecticides.
The
sediments
were
not
analyzed
for
resmethrin.
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
accoradance
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
64
pyrethroids
undergoing
reregistration,
but
also
other
pyrethroids
such
as
bifenthrin
and
lambda­
cyhalothrin.

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
Tennesse,
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
is
currently
performing
specific
toxicity
studies
identified
by
the
Agency
as
data
gaps,
such
as
sediment
invertebrate
toxicity
tests.
65
66
V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
resmethrin
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
Changes
Summary
Table
(
table
XX).
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
productspecific
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
resmethrin
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
24.
Guideline
Requirements
for
Resmethrin
Data
Requirement
Old
Guideline
No.
New
OPPTS
Guideline
No.

Environmental
Fate
and
Ecological
Effects
Data
Requirements
Photodegradation
of
parent
and
degradates
in
soil
(
Photodegradation
in
Soil
of
Resmethrin)
161­
3
835.2410
Aquatic
invertebrate
life
cycle
(
freshwater
and
estuarine/
marine
invertebrates)
72­
4
850.1350
850.1300
Acute
sediment
testing
(
freshwater
and
estuarine/
marine)
(
Freshwater
held
in
reserve)
74­
1
850.1735
850.1740
Chronic
sediment
testing
(
freshwater
and
estuarine/
marine)
EPA/
600/
R­
99/
064
EPA/
600/
R01/
020
Avian
reproduction
test
(
with
bobwhite
quail)
71­
4
850.2300
Fish
early
life­
stage
toxicity
test
(
freshwater
and
estuarine/
marine)
72­
4
850.1400
Fish
acute
toxicity
test
(
freshwater
and
marine)
72­
1
72­
3
850.1075
Aquatic
invertebrate
acute
toxicity
test,
freshwater
daphnids
72­
2
850.1010
Mysid
acute
toxicity
test
72­
3
850.1035
Bivalve
acute
toxicity
test
(
embryo
larval)
72­
3
850.1055
Oyster
acute
toxicity
test
(
shell
deposition)
72­
3
850.1025
Human
Health
Effects
Data
Requirements
90­
Day
neurotoxicity
screening
battery
870.6200b
67
Developmental
neurotoxicity
study
83­
6
870.6300
Nature
of
the
residue
­
plants
171­
4
860.1300
Multiresidue
Method
171­
4
860.1360
Storage
Stability
Data
171­
4
860.1380
Magnitude
of
the
Residue
 
food
handling
 
food
items
171­
4
860.1460
Magnitude
of
the
Residue
 
meat,
milk,
poultry,
eggs
171­
4
860.1480
B.
End­
Use
Products
1.
Additional
Product­
Specific
Data
Requirements
Section
4(
g)(
2)(
B)
of
FIFRA
calls
for
the
Agency
to
obtain
any
needed
productspecific
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
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.

2.
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
25.
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.
68
69
Labeling
Changes
Summary
Table
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
25:
Summary
of
Labeling
Changes
for
Resmethrin
Description
Manufacturing
Use
Products
Placement
on
Label
Formulation
instructions
required
on
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]."

"
Not
for
formulation
into
end
use
products
for
use
in
indoor
metered
spray
systems."

"
Not
for
formulation
into
end
use
products
for
use
in
outdoor
misting
systems."
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
"
Environmental
Hazards
This
product
is
toxic
to
fish,
aquatic
invertebrates,
and
oysters/
shrimp.
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
Pollution
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
70
End
Use
Products
Intended
for
Occupational
Use
Excludes
Products
Intended
for
Use
in
Wide
Area
Mosquito
Abatement
Programs
(
See
below
requirements)

PPE
Requirements
Established
by
the
RED1
for
Liquid
Formulations
(
excludes
formulations
applied
via
ready­
to­
use
aerosols)
"
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.

All
mixers,
loaders,
applicators,
and
other
handlers
must
wear:

­
long
sleeved
shirt
and
long
pants,

­
socks
plus
shoes,
and
­
chemical
resistant
gloves.

Applicators
using
handheld
fog
equipment
must
wear:

­
coveralls
over
long
sleeved
shirt
and
long
pants,

­
chemical­
resistant
gloves,

­
chemical­
resistant
footwear
plus
socks,

­
chemical­
resistant
headgear,
if
overhead
exposure,

­
chemical­
resistant
apron
when
mixing,
loading,
and
cleaning
equipment
or
spills,
and
­
A
NIOSH­
approved
respriator
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.
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED1
for
Ready­
to­
use
Aerosol
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.

All
applicators
and
other
handlers
must
wear:

­
long
sleeved
shirt,
long
pants,
and
­
socks
plus
shoes,
and
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
71
­
chemical­
resistant
gloves."

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."
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
User
Safety
Recommendations
"
User
Safety
Recommendations
Users
should
wash
hands
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.@
Precautionary
Statements
under:

Hazards
to
Humans
and
Domestic
Animals
immediately
following
Engineering
Controls
(
Must
be
placed
in
a
box.)

Environmental
Hazards
for
All
Products
that
have
outdoor
use
sites
Note:
Products
with
indoor
uses
only
see
below
"
Environmental
Hazards
This
pesticide
is
toxic
to
fish,
aquatic
invertebrates,
and
oysters/
shrimp.
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark.
Do
not
contaminate
water
when
disposing
of
equipment
washwater
or
rinsate.

Drift
and
runoff
may
be
hazardous
to
aquatic
organisms
in
water
adjacent
to
treated
areas.

This
product
may
contaminate
water
through
runoff.
This
product
has
a
potential
for
runoff
for
several
days
after
application.
Poorly
draining
soils
and
soils
with
shallow
water
tables
are
more
prone
to
produce
runoff
that
contains
this
product.
A
level,
well
maintained
vegetative
buffer
strip
between
areas
to
which
this
product
is
applied
and
surface
water
features
such
as
ponds,
steams,
and
springs
will
reduce
the
potential
for
contamination
of
water
from
rainfallrunoff
Runoff
of
this
product
will
be
reduced
by
avoiding
applications
when
rainfall
is
forecasted
to
occur
within
48
hours.
Sound
erosion
control
practices
will
reduce
this
product's
contribution
to
surface
water
contamination."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Environmental
Hazards
for
products
that
only
contain
indoor
use
sites
Note
to
registrant:

Products
labeled
solely
for
indoor
use
except
as
noted
below
may
omit
the
Environmental
Hazards
statements.
Such
products
must
have
the
following
statement
in
the
Directions
for
Use:
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
72
"
For
indoor
use
only."

Environmental
Hazards
for
Indoor
Use
Products
packaged
in
containers
equal
to
or
greater
than
5
gallons
or
50
lbs
"
This
pesticide
is
toxic
to
fish,
aquatic
invertebrates,
and
oysters/
shrimp.
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
Pollution
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
Restricted­
Entry
Interval
for
products
with
directions
for
use
within
the
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,
Under
Agricultural
Use
Requirements
Box
Entry
Restrictions
for
all
products
with
indoor
use
sites
AND
directions
for
use
outside
the
scope
of
the
WPS.
For
products
applied
as
crack
and
crevice
and
surface
sprays:

"
Do
not
enter
or
allow
other
people
(
or
pets)
to
enter
the
treated
area
until
sprays
have
dried."

For
products
applied
as
space
sprays
or
fogs:

"
Close
doors,
windows
and
shut
off
all
ventilation
equipment
before
application.
Leave
the
treated
area.
Post
signs
on
entrances
stating
that
the
area
has
been
treated
with
resmethrin
and
that
it
is
to
remain
closed
for
at
least
4
hours
after
application.
Do
not
re­
enter
and
do
not
allow
anyone
else
to
re­
enter
the
site
for
4
hours.
Ventilate
thoroughly
before
anyone
is
allowed
to
re­
enter.

­
Ventilate
thoroughly
for
20
minutes
for
treatment
of
less
than
10,000
cubic
feet
of
space.

­
Ventilate
thoroughly
for
60
minutes
for
treatment
of
less
than
50,000
cubic
feet
of
space.

­
Ventilate
thoroughly
for
120
minutes
for
treatment
of
greater
than
50,000
cubic
feet
of
space."
If
no
WPS
uses
on
the
product,

place
the
appropriate
statement
in
the
Directions
for
Use
Under
General
Precautions
and
Restrictions
If
the
product
also
contains
WPS
uses,
then
create
a
NonAgricultural
Use
Requirements
box
as
directed
in
PR
Notice
93­
7
and
place
the
appropriate
statement
inside
that
box.

Early
Entry
Personal
Protective
Equipment
for
products
with
directions
for
use
within
the
scope
of
the
WPS
"
PPE
required
for
early
entry
to
treated
areas
that
is
permitted
under
the
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."
Directions
for
Use
Inside
the
Agricultural
Use
Requirements
Box
General
Application
"
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
Place
in
the
Direction
for
Use
73
Restrictions
through
drift.
Only
protected
handlers
may
be
in
the
area
during
application."
directly
above
the
Agricultural
Use
Box.

Use­
Specific
Application
Restrictions
Labeling
required
on
all
products:

"
Do
not
use
in
indoor
metered
spray
systems."

"
Do
not
use
in
automatic
misting
systems."

Note:
Registrants
must
amend
the
label
to
include
the
maximum
allowable
application
rate
and
maximum
allowable
rate
per
year
must
be
listed
as
pounds
or
gallons
of
formulated
products
per
acre
or
1000
ft2,
not
just
as
pounds
active
ingredient
per
acre
or
1000
ft2.

Products
labeled
for
use
on
Livestock,
Farm
Animals,
and
Pets
(
Direct
Application):

"
Do
not
apply
with
product
containing
more
than
0.35%
ai."

Products
labeled
for
use
in
Outdoor
Sites
(
Commercial,
Recreational,
Domestic
Outdoor
Sites,

Agricultural
Structures,
Agricultural
Premises,
and
Agricultural
Equipment):

"
Do
not
apply
more
than
0.25
lb
ai
per
acre."

OR
For
ready­
to­
use
products,
registrants
must
amend
their
labels
to
specify
use
rates
that
result
in
no
more
than
0.25
lb
ai
per
acre.

Products
labeled
for
use
in
Space
Applications
(
Greenhouses;
Indoor
Food
Handling/
Processing/
Eating
Establishments;
Commercial
Structure
Premises
and
Equipment;

Domestic
Structure
Premises
and
Equipment):

"
Do
not
apply
more
than
0.001
lb
ai
per
1000
ft2."

OR
For
ready­
to­
use
products,
registrants
must
amend
their
labels
to
specify
use
rates
that
result
in
no
more
than
0.001
lb
ai
per
1000
ft2.

Products
labeled
for
use
in
Surface
Crack
and
Crevice
Application
(
Greenhouses;
Indoor
Food
Handling/
Processing/
Eating
Establishments;
Commercial
Structure
Premises
and
Equipment;
Directions
for
Use
74
Domestic
Structure
Premises
and
Equipment):

"
Do
not
apply
more
than
0.242
lb
ai
per
1000
ft2."

OR
For
ready­
to­
use
products,
registrants
must
amend
their
labels
to
specify
use
rates
that
result
in
no
more
than
0.242
lb
ai
per
1000
ft2
Products
labeled
for
indoor
use
sites:

"
Remove
pets,
birds,
and
cover
aquariums
and
turn
off
air
pumps
before
application.

In
food
processing
operations,
homes,
or
any
other
location
where
food
is
prepared
or
served,

do
not
apply
this
product
while
food
is
exposed
or
being
processed.
Cover
or
remove
all
exposed
food,
packaging
material,
and
food
contact
surfaces.
Do
not
apply
directly
to
food,

packaging
material,
or
any
food
contact
surfaces.

Remove
or
cover
dishes,
utensils,
food
processing
equipment
and
food
preparation
surfaces
before
use
of
this
product.
All
food
processing
surfaces
and
equipment
in
the
treatment
area
must
be
covered
or
washed
with
an
effective
cleaning
compound
followed
by
a
potable
water
rinse
after
use
of
this
product."

For
End­
Use
Products
Intended
for
Wide
Area
Mosquito
Abatement
Programs
Only
Restricted
Use
Pesticide
"
Restricted
Use
Pesticide.
Due
to
Acute
Fish
Toxicity.
For
retail
sale
to
and
use
only
by
certified
applicators
or
persons
under
their
direct
supervision
and
only
for
those
uses
covered
by
the
certified
applicator's
certification.
Direct
supervision
for
this
product
is
defined
as
the
certified
applicator
being
physically
present
during
mixing,
loading,
equipment
repair
and
equipment
cleaning.
Certified
applicators
must
ensure
that
all
persons
involved
in
these
activities
under
their
direct
supervision
are
informed
of
the
precautionary
statements."
Top
front
panel
PPE
Requirements
Established
by
the
RED1
"
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.
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
75
All
mixers,
loaders,
applicators,
and
other
handlers
must
wear:

­
long
sleeved
shirt
and
long
pants,

­
socks
plus
shoes,
and
­
chemical­
resistant
gloves
for
all
handlers
except
applicators.

See
engineering
controls
for
additional
requirements."

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."
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
Engineering
Controls
Engineering
Controls:

"
Applicators
using
ground
mechanical
application
equipment
must
use
an
enclosed
cab
that
has
a
nonporous
barrier
that
totally
surrounds
the
occupants
and
prevents
contact
with
pesticides
outside
the
cab.
Must
be
provided
and
have
immediately
available
for
use
upon
exiting
the
cab
chemical­
resistant
gloves."

"
Pilots
must
use
an
enclosed
cockpit.
The
cockpit
must
have
a
nonporous
barrier
that
totally
surrounds
the
occupants
and
prevents
contact
with
pesticides
outside
the
cab.
Pilots
must
wear
the
PPE
specified
in
this
label
for
applicators."
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
(
Immediately
following
PPE
and
User
Safety
Requirements.)

User
Safety
Recommendations
"
User
Safety
Recommendations
Users
should
wash
hands
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.@
Precautionary
Statements
under:

Hazards
to
Humans
and
Domestic
Animals
immediately
following
Engineering
Controls
(
Must
be
placed
in
a
box.)
76
Environmental
Hazards
"
This
pesticide
is
toxic
to
aquatic
organisms,
including
fish,
crustaceans,
and
oysters.
Runoff
from
treated
areas
or
deposition
of
spray
droplets
into
a
body
of
water
may
be
hazardous
to
fish,
crustaceans,
and
oysters."

"
Do
not
apply
when
bees
are
visiting
the
treatment
area,
except
when
applications
are
made
to
prevent
or
control
a
threat
to
public
and/
or
animal
health
determined
by
a
state,
tribal,
or
local
health
or
vector
control
agency
on
the
basis
of
documented
evidence
of
disease
causing
agents
in
vector
mosquitoes
or
the
occurrence
of
mosquito­
borne
disease
in
animal
or
human
populations,
or
if
specifically
approved
by
the
state
or
tribe
during
a
natural
disaster
recovery
effort."

"
Before
making
the
first
application
in
a
season,
it
is
advisable
to
consult
with
the
state
or
tribal
agency
with
primary
responsibility
for
pesticide
regulation
to
determine
if
other
regulatory
requirements
exist."

"
Do
not
apply
over
bodies
of
water
(
lakes,
rivers,
permanent
streams,
natural
ponds,

commercial
fish
ponds,
swamps,
marshes
or
estuaries),
except
when
necessary
to
target
areas
where
adult
mosquitoes
are
present,
and
weather
conditions
will
facilitate
movement
of
applied
material
away
from
the
water
in
order
to
minimize
incidental
deposition
into
the
water
body.

Do
not
contaminate
bodies
of
water
when
disposing
of
equipment
rinsate
or
washwaters."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Application
Restrictions
"
Do
not
apply
more
than
0.007
lb
ai/
acre
per
application."

"
Do
not
apply
more
than
0.2
lb
ai/
acre
per
year
in
any
treated
area.
More
frequent
treatments
may
be
made
to
prevent
or
control
a
threat
to
public
and/
or
animal
health
determined
by
a
state,

tribal,
or
local
health
or
vector
control
agency
on
the
basis
of
documented
evidence
of
disease
causing
agents
in
vector
mosquitoes
or
the
occurrence
of
mosquito­
borne
disease
in
animal
or
human
populations,
or
if
specifically
approved
by
the
state
or
tribe
during
a
natural
disaster
recovery
effort."

"
Products
must
comply
with
EPA
PR
Notice
2005­
1."
Directions
for
Use
Spray
Drift
Label
Language
for
ALL
Products
Intended
for
SPRAY
DRIFT
MANAGEMENT
Directions
for
Use
under
General
Precautions
and
Restrictions
77
ULV
Mosquito
Abatement
Programs
Only
"
A
variety
of
factors
including
weather
conditions
(
e.
g.,
wind
direction,
wind
speed,

temperature,
relative
humidity)
and
method
of
application
(
e.
g.,
ground,
aerial,
airblast,

chemigation)
can
influence
pesticide
drift.
The
applicator
must
evaluate
all
factors
and
make
appropriate
adjustments
when
applying
this
product."

WIND
SPEED:

"
Do
not
apply
when
wind
speed
is
0
mph."

DROPLET
SIZE:

"
Ground­
based
application:

Spray
equipment
must
be
adjusted
so
that
the
volume
median
diameter
is
less
than
microns
(
Dv
0.5
<
8­
30
um)
and
that
90%
of
the
spray
is
contained
in
droplets
smaller
than
microns
(
Dv
0.9
<
50
um).
Directions
from
the
equipment
manufacturer
or
vendor,
pesticide
registrant
or
a
test
facility
using
a
laxer­
based
measurement
instrument
must
be
used
to
adjust
equipment
to
produce
acceptable
droplet
size
spectra.
Application
equipment
must
be
tested
at
least
annually
to
confirm
that
pressure
at
the
nozzle
and
nozzle
flow
rate(
s)
are
properly
calibrated."

"
Aerial
Application:

Spray
equipment
must
be
adjusted
so
that
the
volume
median
diameter
produced
is
less
than
microns
(
Dv
0.5
<
60
um)
and
that
90%
of
the
spray
is
contained
in
droplets
smaller
than
microns
(
Dv
0.9
<
80
um).
The
effects
of
flight
speed,
and
for
non­
rotary
nozzles,
nozzle
angle
on
the
droplet
size
spectrum
must
be
considered.
Directions
from
the
equipment
manufacturer
or
vendor,
pesticide
registrant
or
a
test
facility
using
a
wind
tunnel
and
laser­
based
measurement
instrument
must
be
used
to
adjust
equipment
to
produce
acceptable
droplet
size
spectra.
EQUIPMENT
CALIBRATION:

Application
equipment
must
be
tested
at
least
annually
to
confirm
that
pressure
at
the
nozzle
and
nozzle
flow
rate(
s)
are
properly
calibrated."

RELEASE
HEIGHT:

Fixed
wing:

"
Apply
using
a
nozzle
height
of
no
less
than
100
feet
above
the
ground
or
canopy."
78
Rotary
wing:

"
Apply
using
a
nozzle
height
of
no
less
than
75
feet
above
the
ground
or
canopy."

BOOM
LENGTH:

"
The
boom
length
must
not
exceed
75%
of
the
wingspan
or
90%
of
the
rotor
blade
diameter."

End
Use
Products
Intended
for
Residential
Use
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
any
person
or
pet,
either
directly
or
through
drift.
Keep
people
and
pets
out
of
the
area
during
application."
Directions
for
Use
under
General
Precautions
and
Restrictions
Entry
Restrictions
For
products
applied
as
crack
and
crevice
and
surface
sprays:

"
Do
not
enter
or
allow
other
people
(
or
pets)
to
enter
the
treated
area
until
sprays
have
dried."

For
products
applied
as
space
sprays
or
fogs:

"
Close
doors,
windows
and
shut
off
all
ventilation
equipment
before
application.
Leave
treated
area
closed
for
at
least
2
hours
after
application.
Do
not
remain
in
treated
area(
s).
Ventilate
thoroughly
for
20
minutes
with
fresh
air
before
re­
occupying
treated
area(
s)."
Directions
for
use
under
General
Precautions
and
Restrictions
Environmental
Hazards
.
For
products
that
have
outdoor
uses:

"
This
product
is
extremely
toxic
to
fish,
aquatic
invertebrates,
and
oysters/
shrimp.
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."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Use­
Specific
Application
Restrictions
Labeling
required
on
all
products
applied
as
sprays:

"
Do
not
use
in
indoor
metered
spray
systems."

"
Do
not
use
in
automatic
misting
systems."

APPLICATION
RATE
RESTRICTIONS:
Directions
for
Use
79
Products
containing
greater
than
0.35%
ai
must
not
be
labeled
for
use
on
pets.

Note:
Registrants
must
amend
the
label
to
reflect
the
below
maximum
allowable
application
rate
per
year.
The
rate
must
be
listed
as
pounds
or
gallons
of
formulated
product
per
acre
or
1000
ft2,
not
just
as
pounds
active
ingredient
per
acre
or
1000
ft2.
For
ready­
to­
use
products,

registrants
must
amend
their
labels
to
specify
use
rates
that
will
result
in
the
below
maximum
application
rates.

Products
labeled
for
use
in
Outdoor
Sites
(
Backyard,
patios,
and
ornamentals):

Maximum
application
rate
0.25
lb
ai
per
acre.

Products
labeled
for
Space
Application
(
domestic
dwellings):

Maximum
application
rate
0.001
lb
ai
per
1000
ft2.

"
Do
not
use
more
than
3
times
a
year."

Products
labeled
for
Surface
Crack
and
Crevice
Application
(
domestic
dwellings):

Maximum
application
rate
0.242
lb
ai
per
1000
ft2.

OTHER
RESTRICTIONS:

Products
labeled
for
use
in
indoor
use
sites:

"
Remove
pets,
birds,
and
cover
aquariums
and
turn
off
air
pumps
before
application."

"
In
homes
or
any
other
location
where
food
is
prepared
or
served,
do
not
apply
this
product
while
food
is
exposed
or
being
processed.
Cover
or
remove
all
exposed
food
and
food
contact
surfaces.
Do
not
apply
directly
to
food,
packaging
material,
or
any
food
contact
surfaces."

"
Remove
or
cover
dishes,
utensils,
food
processing
equipment
and
food
preparation
surfaces
before
use
of
this
product.
All
food
processing
surfaces
and
equipment
in
the
treatment
area
should
be
covered
or
washed
with
an
effective
cleaning
compound
followed
by
a
potable
water
rinse
after
use
of
this
product."

Products
labeled
for
use
in
outdoor
use
sites
except
for
Ready
to
Use
Formulations:
80
"
Do
not
apply
directly
to
or
near
water,
storm
drains,
or
drainage
ditches.
Do
not
apply
when
windy.
To
prevent
product
run­
off,
do
not
over
water
the
treated
area(
s)
or
apply
when
heavy
rain
is
expected.
Rinse
application
equipment
over
lawn
or
garden
area
only."

Ready
to
use
products
labeled
for
outdoor
use
sites:

"
Do
not
apply
directly
to
or
near
water,
storm
drains,
or
drainage
ditches.
Do
not
apply
when
windy.
To
prevent
product
run­
off,
do
not
over
water
the
treated
area(
s)
or
apply
when
heavy
rain
is
expected."

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.
81
Appendix
A
Use
Patterns
Subject
for
Reregistration
of
Resmethrin
Site
Form
Code
Max.
App
Rate/
App
Unit
(
ai)
Use
Pattern/
Limitations
DIRECT
APPLICATION
TO
LIVESTOCK,
FARM
ANIMALS,
AND
PETS
RTU
0.35%
N/
A
OUTDOOR
USE
SITES
(
COMMERCIAL,
RECREATIONAL,
DOMESTIC
OUTDOOR
SITES,
AGRICULTURAL
STRUCTURES,
AGRICULTURAL
PREMISES,
AND
AGRICULTURAL
EQUIPMENT)
EC,
PRL,
RTU,
SC/
L
0.25
lb/
acre
For
ready­
to­
use
products,
registrants
must
amend
their
labels
to
specify
use
rates
that
result
in
no
more
than
0.25
lb
ai
per
acre.

SPACE
APPLICATIONS
(
GREENHOUSES;
INDOOR
FOOD
HANDLING/
PROCESSING/
EATING
ESTABLISHMENTS;
COMMERCIAL
STRUCTURE
PREMISES
AND
EQUIPMENT;
DOMESTIC
STRUCTURE
PREMISES
AND
EQUIPMENT)
EC,
PRL,
RTU
0.001
lb/
1000ft2
For
ready­
to­
use
products,
registrants
must
amend
their
labels
to
specify
use
rates
that
result
in
no
more
than
0.001
lb
ai
per
1000ft2.

SURFACE
CRACK
AND
CREVICE
APPLICATION
(
GREENHOUSES;
INDOOR
FOOD
HANDLING/
PROCESSING/
EATING
ESTABLISHMENTS;
COMMERCIAL
STRUCTURE
PREMISES
AND
EQUIPMENT;
DOMESTIC
STRUCTURE
PREMISES
AND
EQUIPMENT)
EC,
PRL,
RTU
0.242
lb/
1000ft2
For
ready­
to­
use
products,
registrants
must
amend
their
labels
to
specify
use
rates
that
result
in
no
more
than
0.242
lb
ai
per
1000ft2.
82
Site
Form
Code
Max.
App
Rate/
App
Unit
(
ai)
Use
Pattern/
Limitations
END­
USE
PRODUCTS
INTENDED
FOR
WIDE
AREA
MOSQUITO
ABATEMENT
PROGRAMS
EC,
EC*
RTU
0.007
lb/
acre
"
Restricted
Use
Pesticide.
Due
to
Acute
Fish
Toxicity.
For
retail
sale
to
and
use
only
by
certified
applicators
or
persons
under
their
direct
supervision
and
only
for
those
uses
covered
by
the
certified
applicator's
certification.
Direct
supervision
for
this
product
is
defined
as
the
certified
applicator
being
physically
present
during
mixing,
loading,
equipment
repair
and
equipment
cleaning.
Certified
applicators
must
ensure
that
all
persons
involved
in
these
activities
under
their
direct
supervision
are
informed
of
the
precautionary
statements."

"
Do
not
apply
more
than
0.007
lb
ai/
acre
per
application."

"
Do
not
apply
more
than
0.2
lb
ai/
acre
per
year
in
any
treated
area.
More
frequent
treatments
may
be
made
to
prevent
or
control
a
threat
to
public
and/
or
animal
health
determined
by
a
state,
tribal,
or
local
health
or
vector
control
agency
on
the
basis
of
documented
evidence
of
disease
causing
agents
in
vector
mosquitoes
or
the
occurrence
of
mosquito­
borne
disease
in
animal
or
human
populations,
or
if
specifically
approved
by
the
state
or
tribe
during
a
natural
disaster
recovery
effort."

"
Products
must
comply
with
EPA
PR
Notice
2005­
1."
83
Appendix
B
GUIDE
TO
APPENDIX
B
Appendix
B
contains
listings
of
data
requirements
which
support
the
reregistration
for
active
ingredients
within
the
case
2510
covered
by
this
Reregistration
Eligibility
Decision
Document.
It
contains
generic
data
requirements
that
apply
to
2510
in
all
products,
including
data
requirements
for
which
a
"
typical
formulation"
is
the
test
substance.

The
data
table
is
organized
in
the
following
format:

1.
Data
Requirement
(
Column
1).
The
data
requirements
are
listed
in
the
order
in
which
they
appear
in
40
CFR
Part
158.
The
reference
numbers
accompanying
each
test
refer
to
the
test
protocols
set
in
the
Pesticide
Assessment
Guidelines,
which
are
available
from
the
National
Technical
Information
Service,
5285
Port
Royal
Road,
Springfield,
VA
22161
(
703)
487­
4650.

2.
Use
Pattern
(
Column
2).
This
column
indicates
the
use
patterns
for
which
the
data
requirements
apply.
The
following
letter
designations
are
used
for
the
given
use
patterns:

A
Terrestrial
food
B
Terrestrial
feed
C
Terrestrial
non­
food
D
Aquatic
food
E
Aquatic
non­
food
outdoor
F
Aquatic
non­
food
industrial
G
Aquatic
non­
food
residential
H
Greenhouse
food
I
Greenhouse
non­
food
J
Forestry
K
Residential
L
Indoor
food
M
Indoor
non­
food
N
Indoor
medical
O
Indoor
residential
3.
Bibliographic
citation
(
Column
3).
If
the
Agency
has
acceptable
data
in
its
files,
this
column
lists
the
identifying
number
of
each
study.
This
normally
is
the
Master
Record
Identification
(
MRID)
number,
but
may
be
a
"
GS"
number
if
no
MRID
number
has
been
assigned.
Refer
to
the
Bibliography
appendix
for
a
complete
citation
of
the
study.
84
APPENDIX
B
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)

PRODUCT
CHEMISTRY
New
Guideline
Number
Old
Guideline
Number
830.1550
61­
1
Product
Identity
and
Composition
All
42085701,43184901
830.1600
830.1620
830.1650
61­
2A
Start.
Mat.
&
Mnfg.
Process
All
42085701,43184901,43392201,43090801
830.1670
61­
2B
Formation
of
Impurities
All
42085701,43184901,4309081
830.1700
62­
1
Preliminary
Analysis
All
42085702
830.1750
62­
2
Certification
of
limits
All
830.1800
62­
3
Analytical
Method
All
42085702,
43184901,43090802
830.6302
63­
2
Color
All
43241602,
42085703,
43259801,43184901,43435701,
85
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)
43330101,43090803
830.6303
63­
3
Physical
State
All
43241602,
42085703,
43259801,

43184901,43435701,
43330101,
43090803
830.6304
63­
4
Odor
All
43241602,
42085703,
43259801,
43184901,

43435701,
43330101,43090803
830.6314
63­
14
Oxidation/
reduction:
chemical
incompatability
43241602,
42085703,
43259801,
43184901,

43435701,
43330101,
43090803
830.6315
63­
15
Flammability
43241602,
43259801,
43184901,
43435701,

43330101,
43090803
830.6316
63­
16
Explodability
43241602,
42085703,
43259801,
43184901,

43435701,
43330101,
43090803
830.6317
63­
17
Storage
Stability
42085703,43184901,43993701,43993601,43090
803,
40766101
830.6319
63­
19
Miscibility
43241602,
43259801,43184901,
43435701,

43330101,
43090803
830.6320
63­
20
Corrosion
Characteristics
42085703,
43259801,
43184901,
43993701,

43993601,
43090803
830.7100
63­
18
Viscosity
43241602,43259801,
43184901,
43435701,

43330101,
43090803
830.7200
63­
5
Melting
Point
All
42085703
830.7300
63­
7
Density
All
43241602,42085703,43259801,
86
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)
43184901,43435701,
43330101
830.7840
830.7860
63­
8
Solubility
All
42085703
830.7950
63­
9
Vapor
Pressure
All
42085703
830.7370
63­
10
Dissociation
Constant
All
42085703,42143701
830.7550
63­
11
Octanol/
Water
Partition
Coefficient
All
830.7000
63­
12
pH
All
43241602,
42085703,
43184901,
43435701,

43330101,
43090803
830.6313
63­
13
Stability
All
42085703
ECOLOGICAL
EFFECTS
850.2100
71­
1A
Avian
Acute
Oral
Toxicity
­
Quail
ABCIKM
850.2200
71­
2A
Avian
Dietary
Toxicity
­
Quail
ABCIKM
850.2200
71­
2B
Avian
Dietary
Toxicity
­
Duck
ABCK
850.1075
72­
1A
Fish
Acute
Toxicity
Bluegill
ABCK
850.1075
72­
1C
Fish
Acute
Toxicity
Rainbow
Trout
ABCIKM
850.1010
72­
2
Invertebrate
Toxicity
ABCIKM
None
72­
3A
Estuarine/
Marine
Toxicity
­
Fish
ABCK
87
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)

None
72­
3C
Estuarine/
Marine
Toxicity
­
Shrimp
ABCK
None
72­
4B
Estuarine/
Marine
Invertebrate
Life
Cycle
ABCK
122­
2
Aquatic
plant
growth
850.4225
123­
1A
Seed
germ/
seedling
emergence
ABCK
850.4250
123­
1B
Vegetative
vigor
ABCK
850.4400
123­
2B
Aquatic
Plant
Growth,
Tier
2
ABCK
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity­
Rat
ABCIKM
42076201
870.1200
81­
2
Acute
Dermal
Toxicity­
Rabbit
ABCIKM
42076202
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
ABCIKM
42153701
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
ABCIKM
42076203
870.2500
81­
5
Primary
Skin
Irritation
ABCIKM
42076204
870.2600
81­
6
Dermal
Sensitization
ABCIKM
42153702
870.3100
82­
1A
90­
Day
Feeding
­
Rodent
ABCIKM
43338601,
43838101
870.3200
82­
2
21­
Day
Dermal
­
Rabbit/
Rat
ABCHIK
42066901
870.3465
82­
4
90­
Day
Inhalation
00158476
88
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)

870.4100
83­
1A
Chronic
Feeding
Toxicity
­
Rodent
ABCIKM
00157961,43601601
870.4100
83­
1B
Chronic
Feeding
Toxicity
­
Non­

Rodent
ABCIKM
43062601
870.4200
83­
2A
Oncogenicity
­
Rat
ABCIKM
0083319
870.4200
83­
2B
Oncogenicity
­
Mouse
ABCIKM
43052101
870.4300
83­
5
Chronic/
Oncogenicity
00041402,00085870,00108628,43271701,

43601601,00041402,00108828
870.3700
83­
3A
Developmental
Toxicity
­
Rat
ABCIKM
00028453,

870.3700
83­
3B
Developmental
Toxicity­
Non
Rodent
46582601,00029002
870.3800
83­
4A
2­
Generation
Reproduction
­
Rat
ABCIKM
43189101,

870.3800
83­
4B
Reproduction
00081276,
124308
870.5140
84­
2A
Gene
Mutation
(
Ames
Test)
ABCIKM
870.5265
41068010
870.5375
84­
2B
Structural
Chromosomal
Aberration
ABCIKM
41068011,

870.5550
84­
2
870.6200
82­
7A
Acute
Neurotox.
Screening
Battery
(
rat)
00025552,00025553,00025554
870.6200
82­
7B
90
Day
Neuro.
Screening
Battery
(
rat)
89
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)

None
84­
4
Other
Genotoxic
Effects
ABCIKM
870.7485
85­
1
General
Metabolism
ABCIKM
42133801,42136101
870.7600
85­
3
Dermal
Penetration
46382501
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2100
132­
1A
Foliar
Residue
Dissipation
ABCIK
ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
ABCIK
470077046
835.2240
161­
2
Photodegradation
­
Water
ABCK
00153059,

835.2410
161­
3
Photodegradation
­
Soil
ABC
161­
4
835.4100
162­
1
Aerobic
Soil
Metabolism
ABCIK
41913601,
41913601
162­
2
Anaerobic
soil
Metabolism
835.4400
162­
3
Anaerobic
Aquatic
Metabolism
ABC
42298401
162­
4
Aerobic
Aquatic
Metabolism
42043003
835.1240
163­
1
Leaching/
Adsorption/
Desorption
ABCIK
163­
2
163­
3
90
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)

835.6100
164­
1
Terrestrial
Field
Dissipation
ABCK
164­
2
164­
3
165­
4
165­
5
166­
1
166­
2
201­
1
202­
1
RESIDUE
CHEMISTRY
860.1300
171­
4A
Nature
of
Residue
­
Plants
ABK
860.1300
171­
4B
Nature
of
Residue
­
Livestock
AB
860.1340
171­
4C
Residue
Analytical
Method
­

Plants/
Animals
ABK
860.1340
171­
4D
Residue
Analytical
Method­
Animal
860.1360
171­
4M
Multiresidue
Method
860.1380
171­
4E
Storage
Stability
ABK
91
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(
S)

860.1480
171­
4J
Magnitude
of
Residues
­

Meat/
Milk/
Poultry
/
Egg
ABK
860.1500
171­
4K
Crop
Field
Trials
(
Potatoes)
ABK
OTHER
860.1850
165­
1
Confined
Accumulation
in
Rotational
ABC
810.1900
165­
2
Field
Accumulation
in
Rotational
ABC
840.1200
202­
1
Drift
field
evaluation
a­
TGAI
is
a
solid
at
room
temperature.

b­
Data
used
to
support
carbendazim.

c­
Additional
data
is
needed.
The
registrant
has
proposed
two
HPLC/
UV
methods
for
enforcing
tolerances
of
thiophenate­
methyl
in
plant
(
Method
BR­
93­
28)
and
animal
(
Method
KP­
100­
04)
commodities.
Prior
to
validation
by
the
Agency,
the
method
should
be
radiovalidated
using
samples
from
animal
and
plant
metabolism
studies.

d­
Multiresidue
method
(
MRM)
recovery
data
are
required
for
thiophenate­
methyl
and
MBC
through
FDA
protocols
A
through
G.

e­
Data
are
required
depicting
the
frozen
storage
stability
of
thiophenate­
methyl
and
MBC
in
representative
raw
and
processed
plant
commodities
held
in
frozen
storage
for
up
to
five
years.

f­
Additional
field
trial
in
CA
is
required
(
see
residue
chemistry
chapter).

g­
Data
are
required
depicting
residues
of
thiophenate­
methyl
and
MBC
in/
on
green
onions
harvested
at
the
minimum
interval
following
a
broadcast
application
at
planting
of
thiophenate­
methyl
(
WP/
WDG/
FIC)
at
1.4
lb
ai/
A.
A
minimum
of
three
field
trials
should
be
conducted;
two
in
Region
10
and
one
in
Region
6.

h­
If
the
registrant
intends
to
support
a
use
on
dry
peas
and
lentils,
additional
residue
data
for
dried
peas
need
to
be
submitted.
92
i­
To
support
this
group
crop
tolerance,
the
registrant
has
submitted
representative
field
trials
for
the
following
representative
crops:

cucumbers,
melon,
pumpkin
and
squash.

j­
The
available
residue
data
are
inadequate
because
of
deficiencies
in
analytical
method.

N/
A
not
applicable.
93
Appendix
C
TECHNICAL
SUPPORT
DOCUMENTS
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
Room
S­
4400,
One
Potomac
Yard
(
South
Building),
1777
S.
Crystal
Drive,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
am
to
4
pm.

The
preliminary
risk
assessments
for
permethrin
are
available
in
the
public
docket
and
in
e­
dockets
under
docket
number
OPP­
2004­
0385.
This
contains
risk
assessments
and
related
documents
as
of
August
2005.
During
the
comment
period,
the
registrant
submitted
additional
data
for
permethrin.
EPA
reviewed
these
data
and
incorporated
them
into
the
revised
risk
assessments
for
permethrin.
These
revised
risk
assessments
form
the
basis
of
the
regulatory
decision
described
in
this
RED.
These
risk
assessment
and
related
documents
are
available
under
docket
number
OPP­
2004­
0385.

Technical
support
documents
for
the
Permethrin
RED
include
the
following:

Human
Health
Risk
Assessment
Documents;
1.
Resmethrin
HED
Revised
Risk
Assessment
for
Reregistration
Eligibility
Document
(
RED)
PC
Code
097801;
DP
Barcode
326088,
dated
February
23,
2006.
2.
Resmethrin:
Response
to
Public
Comments
on
the
HED
Risk
Assessment
for
Resmethrin
RED
Chapter;
PC
Code
097801;
DP
Barcode
291445,
dated
February
23,
2006.
3.
Resmethrin
and
Bioresmethrin.
Revised
Product
and
Residue
Chemistry
Considerations
for
Reregistration
Eligibility
Decisions,
dated
February
16,
2006.
4.
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
(
RED)
for
Resmethrin,
dated
February
23,
2006.
5.
Resmethrin
Revised
Chronic
and
Cancer
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
PC
Code
097801
DP
Barcode
326090,
dated
February
22,
2006.

Environmental
Fate
and
Effects
Documents;
1.
EFED
RED
Chapter
for
Resmethrin,
Revision
Phase
3,
dated
March
8,
2006.
2.
Response
to
Comments
of
the
Phase
3
Period
for
the
Revised
Draft
EFED
RED
Chapter
for
Resmethrin,
dated
March
8,
2006.
3.
Revised
Tier
II
Estimated
Drinking
Water
Concentrations
for
Resmethrin,
dated
February
13,
2006.
4.
Preliminary
Environmental
Fate
and
Effects
Division
Risk
Assessment
Chapter
for
the
Reregistration
Eligibility
Decision
(
RED)
Document
for:
Resmethrin,
dated
March
8,
2006.
94
5.
Appendicies
to
the
EFED
Risk
Assessment
Chapter
for
the
RED
Document
for
Resmethrin,
dated
March
8,
2006
95
Appendix
D
Bibilography
MRID
Citation
Reference
Human
Health
Studies
43338601
Kangas,
L.
(
1989)
A
4­
Week
Dietary
Toxicity
Study
of
SBP­
1382
in
the
Albino
Mouse:
Lab
Project
Number:
83753.
Unpublished
study
prepared
by
Bio­
Research
Lab.
Ltd.
241
p.
42066901
Meyers,
L.
(
1991)
21­
Day
Percutaneous
Toxicity
Study
of
Resmethrin
in
Rabbits:
Lab
Project
Number:
HWA
2623­
100:
RBT­
90­
217.
Un­
published
study
prepared
by
Hazleton
Washington,
Inc.
312
p.
00025552
Schwartz,
C.
S.;
Becci,
P.
J.;
Parent,
R.
A.;
et
al.
(
1979)
Report:
Evaluation
of
the
Neurotoxic
Effects
of
SBP­
1382
in
Albino
Rats­­
Phase
1:
FDRL
Study
#
6067.
Includes
method
dated
Jul
2,
1979.
(
Unpublished
study
including
letter
dated
Nov
28,
1979
from
R.
W.
Fogleman
to
B.
B.
Brown
and
Maarten
devries,
received
Dec
19,
1979
under
432­
487;
prepared
by
Food
and
Drug
Research
Laboratories,
Inc.,
submitted
by
Penick
Corp.,
Lyndhurst,
N.
J.;
CDL:
241501­
B)
00025553
Cox,
G.
E.;
Becci,
P.
J.;
Parent,
R.
A.;
et
al.
(
1979)
Supplementary
Report
for
Evaluation
of
the
Neurotoxic
Effects
of
SBP­
1382
in
Albino
Rats­­
Phase
I:
FDRL
Study
#
6362.
(
Unpublished
study
in­
cluding
letter
dated
Nov
28,
1979
from
R.
W.
Fogleman
to
B.
B.
Brown
and
Maarten
L.
derVies,
prepared
by
Food
and
Drug
Research
Laboratories,
Inc.,
received
Dec
19,
1979
under
432­
487;
submit­
ted
by
Penick
Corp.,
Lyndhurst,
N.
J.;
CDL:
241502­
B)
00025554
Schwartz,
C.
S.;
Becci,
P.
J.;
Parent,
R.
A.;
et
al.
(
1979)
Report:
Evaluation
of
the
Neurotoxic
Effects
of
SBP­
1382
in
Albino
Rats:
Phase
II:
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40MF
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#
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