Document ID: EPA-HQ-OPP-2005-0030-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-03-07T05:00Z

PESTICIDE
REGISTRATION
(
PR)
NOTICE
2005
­
1
NOTICE
TO
MANUFACTURERS,
PRODUCERS,
FORMULATORS
AND
REGISTRANTS
OF
PESTICIDE
PRODUCTS
ATTENTION:
Persons
Responsible
for
Federal
Registration
and
Reregistration
of
Pesticide
Products
SUBJECT:
Labeling
Statements
on
Products
Used
for
Adult
Mosquito
Control
This
Notice
presents
the
Agency's
guidance
on
appropriate
label
language
for
pesticide
products
intended
for
wide­
area
application
to
control
adult
mosquitoes.
EPA
undertakes
initiatives
such
as
this
in
order
to
improve
and
clarify
pesticide
product
labeling.
The
specific
label
statements
and
label
organization
principles
recommended
in
this
Notice
are
intended
to
improve
existing
labels
by
clarifying
language
conveying
environmental
hazards
posed
by
these
products,
as
well
as
specific
use
directions
and
instructions
to
the
applicators.
The
Agency
believes
that
adoption
of
these
recommendations
will
help
both
pesticide
users
and
pesticide
enforcement
officials
to
improve
effective
mosquito
control
and
protection
of
public
health,
while
ensuring
that
use
of
these
products
will
not
pose
unreasonable
risks
to
the
environment.
The
Agency
believes
the
incremental
cost
of
label
modifications
is
outweighed
by
the
benefits
to
public
health
protection
by
having
appropriate
label
statements
that
help
ensure
the
proper
and
effective
use
of
these
products
for
mosquito
control.

I.
BACKGROUND
In
recent
years
state
pesticide
regulators
and
vector
control
agencies
have
raised
a
variety
of
concerns
about
the
labeling
of
pesticides
used
for
adult
mosquito
control.
For
example,
in
1999
the
State
FIFRA
Issues
Research
and
Evaluation
Group
(
SFIREG)
submitted
an
issue
paper
to
the
Agency
raising
two
specific
concerns
about
such
labeling.
(
SFIREG
is
a
committee
of
the
Association
of
American
Pesticide
Control
Officials,
and
its
public
meetings
serve
as
a
forum
for
state
regulators
to
discuss
issues
concerning
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)
with
Agency
officials
and
other
interested
parties).
The
SFIREG
paper
noted
that
the
statement
"
do
not
apply
directly
to
water"
which
appears
on
many
outdoor
use
pesticide
products,
if
broadly
interpreted,
would
severely
restrict
the
application
of
mosquito
adulticides,
especially
in
Page
2
floodwater
situations,
such
as
those
encountered
in
the
aftermath
of
hurricane
Floyd
in
September
1999.
SFIREG
also
noted
that
the
standard
label
language
intended
to
protect
bees,
which
prohibits
pesticide
applications
"...
to
blooming
crops
or
weeds
if
bees
are
visiting
the
treatment
area",
could
be
seen
as
making
virtually
any
daylight
application
of
mosquito
adulticides
a
violation
of
the
label,
even
during
an
urgent
threat
to
public
health.
Since
state
agencies
enforce
pesticide
use
regulations
under
cooperative
agreements
with
EPA,
and
since
FIFRA
section
12(
a)(
2)(
G)
makes
it
an
unlawful
act
"
to
use
any
registered
pesticide
in
a
manner
inconsistent
with
its
labeling",
the
interpretation
of
label
requirements
is
a
critical
issue
for
EPA
headquarters
and
regional
offices,
state
pesticide
regulatory
agencies,
and
users.

In
February
2001,
the
increasing
impact
of
West
Nile
Virus
on
vector
control
and
regulatory
agencies
led
EPA's
Region
II
office
to
sponsor
an
Inter­
Regional
Mosquito
Control
Conference
for
EPA
and
state
agency
representatives.
Although
labeling
was
one
of
many
subjects
discussed
at
the
conference,
participants
felt
this
was
an
area
that
should
be
addressed.
It
was
agreed
that
a
group
representing
EPA's
Office
of
Pesticide
Programs
(
OPP),
Office
of
Enforcement
and
Compliance
Assurance
(
OECA),
EPA
Regional
offices
and
state
lead
agency
volunteers
would
develop
initial,
informal
proposals
for
improving
mosquito
control
product
labels,
with
the
focus
on
adulticides
only.
The
EPA­
State
workgroup
developed
a
paper
which
included
seven
recommendations.
It
also
raised
the
question
of
overriding
bee
protection
use
directions
in
a
public
health
emergency,
but
did
not
make
a
recommendation
on
that
issue.

In
April
2003,
the
initial
recommendations
were
discussed
at
a
public
meeting
of
the
Pesticide
Program
Dialogue
Committee
(
PPDC).
The
PPDC
is
chartered
under
the
Federal
Advisory
Committee
Act
to
advise
EPA
on
pesticide
issues.
Its
members
represent
a
broad
spectrum
of
interests,
including
the
pesticide
industry,
grower
groups,
public
health
agencies,
academic
researchers,
public
interest
and
advocacy
organizations.
In
general,
PPDC
agreed
that
improved
labeling
for
this
class
of
products
should
be
pursued,
and
that
the
initial
set
of
recommendations
were
generally
appropriate,
but
needed
further
development.
PPDC
recommended
that
EPA
develop
the
initial
recommendations
into
more
formal
Agency
positions.

This
notice
is
the
result
of
Agency
deliberations
and
public
input,
and
represents
the
Agency's
formal
recommendations.
The
recommendations
consist
of
some
specific
statements
that
should
generally
appear
on
labels
for
this
class
of
products,
some
model
statements
that
registrants
may
adapt
to
the
specific
characteristics
of
their
products,
and
some
principles
on
organizing
elements
of
the
label.

II.
PRODUCTS
POTENTIALLY
AFFECTED
BY
THIS
NOTICE
Since
current
labels
for
adult
mosquito
control
products
show
a
great
deal
of
variation,
the
relevance
of
the
recommendations
in
this
Notice
will
vary
from
product
to
product.
Registrants
are
encouraged
to
review
and,
as
appropriate,
apply
to
amend
their
product
labels
for
insecticides
registered
for
wide­
area
adult
mosquito
control
to
include
the
additional
or
revised
use
directions
Page
3
and
other
statements,
and
take
related
actions
as
described
in
this
Notice.
These
recommendations
apply
to
products
labeled
for
wide­
area
application
by
ground
or
aerial
equipment,
as
Ultra
Low
Volume
(
ULV)
sprays
or
fogs,
and
not
to
home
and
garden
use
products
which
may
list
mosquitoes
on
the
label,
or
to
coarse
non­
ULV
sprays
intended
for
residual
treatment
of
vegetation
or
other
surfaces.
Control
of
mosquito
larvae
is
a
wholly
different
use
pattern
from
adult
mosquito
control,
and
thus,
products
registered
as
mosquito
larvicides
are
not
included
in
the
scope
of
this
Notice.

III.
DISCUSSION
OF
ISSUES
AND
RECOMMENDATIONS
This
section
presents
seven
labeling
issues
the
Agency
wishes
to
address,
followed
by
a
statement
of
a
specific
improvement
that
the
Agency
believes
appropriate
to
deal
with
each
issue.
The
label
improvements
recommended
in
this
Notice
are
not
identical
to
the
seven
initial
recommendations
presented
to
the
PPDC
in
April
2003.
In
some
cases,
the
initial
recommendation
was
stated
as
a
general
principle,
which
has
now
been
developed
into
specific
language.
The
Agency's
own
assessment
led
to
merging
some
of
the
initial
recommendations
and
adding
new
ones.

The
general
purpose
of
these
recommendations
is
to
improve
consistency
in
the
labeling
of
this
group
of
products.
Differences
in
use
directions
and
hazard
statements
are
appropriate
for
different
active
ingredients,
formulations
or
application
methods.
However,
since
products
were
registered
and
labels
approved
individually
over
many
years,
variations
have
occurred
in
the
level
of
detail
for
use
directions
and
approaches
to
precautionary
language,
especially
those
related
to
hazards
to
aquatic
organisms.
The
Agency
has
identified
seven
aspects
of
labeling
discussed
below
for
which
consistency
rather
than
differences
among
labels
for
this
class
of
product
would
generally
better
serve
the
needs
of
users,
regulators
and
the
public.

Most
publicly
supported
mosquito
or
vector
control
programs
use
an
Integrated
Pest
Management
(
IPM)
approach
to
mosquito
control
which
includes
public
education,
control
of
mosquito
larvae
through
habitat
modification
and
the
use
of
registered
larvicides,
breeding
site
elimination
and
bite­
prevention
advice
for
the
public,
as
well
as
wide­
area
spraying
or
fogging
when
necessary
to
control
adult
populations.
EPA
supports
IPM
approaches
in
its
public
outreach
materials
and
believes
that
the
use
of
mosquito
adulticides
should
be
consistent
with
IPM
principles,
including
the
use
of
mosquito
population
surveillance
data
in
determining
treatment
schedules.
Similarly,
mosquito
control
program
guidance
developed
by
the
federal
Centers
for
Disease
Control
and
Prevention
(
CDC)
and
interim
recommendations
developed
by
the
Association
of
State
and
Territorial
Health
Officials
(
ASTHO)
also
advocate
the
use
of
an
array
of
control
strategies
with
adulticide
applications
as
one
available
component.

Wide­
area
adult
mosquito
control
employs
different
techniques
from
those
used
to
control
most
other
insect
pests.
Mosquito
adulticides
are
typically
applied
as
Ultra­
Low
Volume
(
ULV)
sprays
or
fogs
in
which
small
amounts
of
pesticide,
typically
a
few
ounces
per
acre,
are
dispersed
over
a
relatively
wide
area
in
the
form
of
extremely
fine
droplets.
Optimum
control
is
achieved
by
Page
4
the
dispersion
of
the
ULV
spray
over
a
wide
area
in
order
to
make
direct
contact
with
mosquitoes
in
flight.
In
other
words,
the
primary
area
being
treated
by
a
ULV
spray
is
the
air
where
flying
mosquitoes
are
present,
rather
than
a
specific,
defined
area
of
infestation
on
the
ground.
Since
mosquitoes
are
often
found
in
close
proximity
to
and
over
bodies
of
water,
effective
targeting
of
ULV
sprays
may
require
application
of
the
pesticide
over
or
near
a
body
of
water
in
order
to
disperse
the
pesticide
to
a
downwind
area
where
mosquitoes
are
present.
Given
the
tendency
of
a
ULV
spray
to
stay
airborne
and
be
carried
by
wind,
deposition
of
pesticide
droplets
to
a
body
of
water
may
occur
on
some
occasions,
even
though
this
is
incidental
to
the
intended
application.
A
body
of
water
is
never
the
intended
target
site
of
application
for
a
mosquito
adulticide.
These
pesticides
are
applied
over,
as
opposed
to
directly
to,
water.

All
currently
registered
pesticides
for
adult
mosquito
control
pose
some
degree
of
risk
to
aquatic
organisms,
and
the
synthetic
pyrethroids,
such
as
permethrin,
sumithrin
and
resmethrin,
are
considered
very
toxic
to
aquatic
organisms.
All
of
the
commonly
used
adulticides
carry
label
precautions
to
warn
of
potential
adverse
effects
to
aquatic
life.
To
avoid
such
adverse
effects,
an
applicator
treating
areas
near
water
must
calculate
many
factors
in
order
to
avoid
depositing
spray
material
into
a
body
of
water.
Weather
conditions
including
wind
speed
and
direction
are
important,
but
other
factors
that
determine
how
far
a
spray
will
carry
include
the
size
of
the
spray
droplets,
the
height
above
ground
at
which
spray
is
applied,
nozzle
orientation,
the
flow
rate,
and
the
speed
of
the
delivery
vehicle.
Some
of
these
factors
are
addressed
by
label
directions,
but
as
noted
above,
with
varying
degrees
of
specificity
among
different
products.
The
recommendations
given
below
are
intended
to
improve
the
clarity
of
certain
use
directions
and
precautions,
and
bring
about
more
consistency
among
labels
for
this
group
of
products.
The
Agency
believes
that
adopting
these
recommendations
will
assist
users
in
making
effective
mosquito
control
applications
with
minimal
risks
to
the
environment.
Clear
and
consistent
labels
also
assist
regulators
and
the
public
in
recognizing
appropriate
application
practices.

Issue
1.
Adult
mosquito
control
applications
should
be
limited
to
trained
personnel.

Adult
mosquito
control
often
includes
treatment
of
residential
areas
and
publically
controlled
lands,
and
typically
involves
special
ground
or
aerial
equipment
for
applying
Ultra
Low
Volume
(
ULV)
sprays
or
fogs.
Correct
use
of
the
equipment
and
application
techniques
require
adequate
training.
The
state
and
local
agencies
responsible
for
vector
control
programs
are
also
accountable
to
the
public
for
ensuring
safe
and
effective
applications.
Given
the
complex
application
methods
and
the
potential
of
the
adulticide
chemicals
to
cause
adverse
effects
to
the
aquatic
environment
if
misapplied,
there
is
broad
agreement
among
interested
parties
that
proper
training
and
supervision
of
applicators
are
essential
to
avoid
adverse
effects
and
ensure
a
safe
and
effective
mosquito
abatement
program.
However,
there
is
not
complete
agreement
on
how
best
to
accomplish
this
goal.
For
example,
state
laws
can
limit
the
use
of
pesticides
for
wide­
area
mosquito
control
to
persons
trained
in
a
specified
manner,
and
some
states
do
have
such
requirements.
However,
not
all
states
limit
use
in
this
manner.
Since
pesticide
use
regulation
is
geared
to
enforcing
label
provisions,
there
is
a
strong
interest
among
regulators
in
using
the
label
to
help
Page
5
ensure
use
by
appropriately
trained
and
supervised
applicators.

One
way
to
ensure
use
or
supervision
by
trained
applicators
is
to
classify
a
product
for
restricted
use.
Products
classified
by
EPA
for
restricted
use
under
section
3(
d)
of
FIFRA
are
labeled
as
such,
and
may
only
be
applied
by
or
under
the
direct
supervision
of
a
certified
applicator.
Each
state
has
an
EPA­
approved
certification
and
training
(
C
&
T)
program
for
the
purpose
of
allowing
trained
applicators
to
use
restricted
pesticides.
Resmethrin,
sumithrin,
permethrin,
malathion
and
naled
are
among
the
pesticides
most
often
used
for
adult
mosquito
control
programs.
Products
using
the
active
ingredient
resmethrin
are
classified
by
the
Agency
as
restricted
use
products
(
RUPs),
and
some
states
restrict
other
mosquito
control
products
through
state
regulations.
However,
at
this
time,
most
of
the
pesticides
used
in
adult
mosquito
control
are
not
classified
for
restricted
use.
As
noted
above,
some
states
do
require
health
or
vector
control
agency
personnel
or
their
contractors
to
be
certified
even
though
RUP
products
are
not
used.
However,
other
states
require
a
lower
level
of
training
or
none
at
all
for
mosquito
control
applicators,
unless
RUPs
are
being
applied.

Independent
of
EPA's
authority
to
classify
a
product
for
restricted
use
pursuant
to
FIFRA
section
3(
d),
it
is
also
possible
to
limit
use
to
appropriate
personnel
through
enforceable
use
instructions,
provided
that
the
label
language
identifies
a
clearly
defined
group
of
potential
applicators.
It
would
not
be
effective,
however,
to
use
a
phrase
that
is
ambiguous
or
subject
to
broad
interpretation,
such
as
"
pest
control
professionals".
Since
there
is
considerable
variation
among
state
programs
for
both
the
regulation
of
vector
control
applicators
and
the
certification
categories
that
cover
training
for
mosquito
control,
the
Agency
has
not
been
able
to
identify
a
universally
appropriate
training
requirement
to
include
on
product
labels.
However,
the
Agency
believes
that
limiting
the
use
of
mosquito
adulticides
to
appropriately
trained
and
supervised
persons
should
be
part
of
the
label
of
any
such
product
which
is
not
already
classified
for
restricted
use.
In
the
recommendation
below
the
term
"
direct
supervision"
is
similar
in
meaning
to
the
FIFRA
definition
of
"
under
the
direct
supervision
of
a
certified
applicator"
(
FIFRA
section
2
(
e)(
4)),
that
is,
the
applicator
must
act
under
the
instruction
and
control
of
an
appropriately
authorized
person,
but
such
person
does
not
have
to
be
physically
present
at
the
time
and
place
the
pesticide
is
applied.
It
is
the
Agency's
position
that
the
following
statement
should
appear
on
the
label
of
non­
restricted
use
products
labeled
for
wide­
area
adult
mosquito
control:

Recommendation
1.
"
For
use
only
by
federal,
state,
tribal,
or
local
government
officials
responsible
for
public
health
or
vector
control,
or
by
persons
certified
in
the
appropriate
category
or
otherwise
authorized
by
the
state
or
tribal
lead
pesticide
regulatory
agency
to
perform
adult
mosquito
control
applications,
or
by
persons
under
their
direct
supervision."

Issue
2.
Some
products
combine
adult
mosquito
control
and
other
uses
on
the
same
label,
generating
uncertainty
about
which
directions
and
precautions
are
applicable
to
which
uses.
Page
6
The
Agency
believes
that
adult
mosquito
control
products
should
be
labeled
solely
for
adult
mosquito
control,
or
for
mosquitoes
and
other
pests
such
as
blackflies
or
midges
which
are
treated
in
essentially
the
same
manner.
Different
uses
involve
different
use
directions
and
precautionary
statements,
which
can
be
confusing
when
they
appear
on
a
single
label.
For
example,
among
products
currently
labeled
for
agricultural
uses
in
addition
to
mosquito
control,
the
"
Environmental
Hazards"
section
of
the
label
usually
includes
this
statement:
"
For
terrestrial
uses,
do
not
apply
directly
to
water
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark."
In
this
context,
EPA
employs
"
terrestrial
uses"
as
a
collective
term
for
conventional
agricultural
and
non­
agricultural
outdoor
uses,
but
the
term
is
not
meant
to
include
certain
other
general
use
patterns
including
adult
mosquito
control,
direct
aquatic
applications
(
e.
g.,
mosquito
larvicides,
aquatic
weed
control,
etc.),
greenhouse
applications,
indoor
uses,
or
aerial
forestry
applications.
The
statement
has
become
virtually
standard
on
outdoor
use
pesticides.
Thus,
on
some
labels,
the
qualifying
phrase
"
For
terrestrial
uses"
introduces
an
environmental
hazard
section
of
the
label
that
is
intended
to
distinguish
these
other
uses
from
mosquito
adulticide
treatments.
However,
the
overall
effect
is
that
when
the
language
quoted
above
appears
on
a
label
of
a
product
intended
for
multiple
uses,
it
may
not
be
clear
to
users
that
it
does
not
apply
to
adult
mosquito
control.
To
avoid
confusion
over
what
language
is
meant
to
apply
to
adult
mosquito
control,
products
should
be
labeled
solely
for
that
use.
If
a
label
does
include
non­
mosquito
control
use
directions,
it
is
essential
to
distinguish
portions
of
the
label
applicable
to
different
uses.

Recommendation
2.
Products
labeled
for
wide­
area
adult
mosquito
control
should
not
bear
container
labeling
for
uses
unrelated
to
adult
mosquito
control.
The
standard
terrestrial
use
water
hazard
statement
should
not
appear
on
product
containers
labeled
solely
for
mosquito
control.
If
a
container
label
includes
non­
mosquito
control
use
directions,
those
directions
and
associated
precautions
should
be
clearly
distinguished
from
those
applicable
to
mosquito
control.
The
terrestrial
use
statements
on
a
mixed­
use
label
should
be
followed
by
the
statement
"
See
separate
directions
and
precautions
for
mosquito
control
applications."

Issue
3.
Label
statements
intended
to
protect
bodies
of
water
and
aquatic
life
should
be
harmonized,
as
well
as
improved
to
assist
effective
mosquito
control
applications.

The
precautionary
label
language
intended
to
manage
risks
to
aquatic
life
varies
considerably
from
product
to
product.
For
example,
some
permethrin
based
mosquito
control
products
direct
the
user
not
to
apply
the
product
within
100
feet
of
lakes
or
streams.
This
restriction
or
"
buffer
zone"
was
put
on
many
permethrin
labels
out
of
concern
for
aquatic
toxicity
that
might
result
due
to
runoff
from
agricultural
sites,
not
as
a
result
of
an
assessment
of
risks
associated
with
the
significantly
lower
concentrations
of
the
active
ingredient
involved
in
ULV
mosquito
control
applications.
Resmethrin
product
labels
state
"
Avoid
direct
application
over
lakes,
ponds
and
streams"
(
emphasis
added),
but
the
same
labels
state
that
vegetation
"
around
stagnant
pools,
marshy
areas,
ponds
and
shorelines
may
be
treated"
and
there
is
no
buffer
zone
requirement.
Products
based
on
other
active
ingredients,
including
malathion
and
sumithrin,
have
label
warnings
about
hazards
to
aquatic
organisms,
but
neither
buffer
zones
nor
the
prohibition
of
"
over
water"
Page
7
applications
appear
on
these
labels.
Naled
labels
explicitly
do
allow
application
over
water
in
order
to
treat
adult
mosquitoes,
blackflies
or
houseflies.

For
different
active
ingredients,
differing
environmental
hazard
statements
may
be
warranted,
based
on
the
level
of
risks
posed.
Generally,
however,
the
Agency
believes
that
a
consistent
approach
to
the
environmental
hazard
label
statements
for
this
class
of
products
is
a
practical
benefit
to
both
users
and
enforcement
agencies
and
should
be
achieved
where
permissible
under
FIFRA.
The
language
recommended
in
this
notice
will
help
to
resolve
inconsistencies
among
labels,
although
departures
from
this
language
may
prove
necessary
on
a
case­
by­
case
basis.
For
example,
the
Agency
may
not
approve
an
application
for
an
amended
label
based
on
these
recommendations,
if
analysis
indicates
that
the
amended
label
would
lead
to
increased
risks
to
aquatic
organisms
compared
to
the
previous
label
for
that
product.

The
recommended
language
will
also
help
to
achieve
the
objective
of
effective
mosquito
control.
From
a
vector
control
point
of
view,
applications
sometimes
do
need
to
be
made
over
or
near
bodies
of
water
in
order
to
reach
areas
where
mosquitoes
are
present,
and
limitations
such
as
buffer
zones
or
"
over
water"
prohibitions
can
impede
effective
control.
For
example,
an
"
over
water"
prohibition
may
sometimes
interfere
unnecessarily
with
the
timely
treatment
of
infested
areas
adjacent
to
water
if
an
area
happens
to
be
downwind
of
a
water
body.
In
such
cases,
the
pesticide
needs
to
be
applied
over
the
water
in
order
to
target
mosquitoes
in
the
air
above
and
adjacent
to
the
water.
Similarly,
a
100­
foot
buffer
zone
may
require
leaving
potentially
infested
areas
untreated
if
they
happen
to
be
within
100
feet
of
a
water
body.
In
mosquito
control,
ULV
sprays
or
fogs
are
intended
to
remain
in
the
air
for
an
extended
time,
unlike
typical
agricultural
applications
where
the
droplets
are
intended
to
fall
immediately.
Thus,
mitigating
risks
to
water
bodies
during
mosquito
control
applications
is
best
accomplished
by
controlling
for
such
factors
as
droplet
size,
wind
direction
and
speed,
application
rate
and
the
height
and
speed
of
release,
rather
than
an
absolute
prohibition
on
application
over
water
or
a
buffer
zone
requirement.
Under
the
language
in
today's
recommendation,
mosquito
adulticides
can
be
applied
over
water
bodies
when
such
application
is
necessary
to
target
mosquitoes
in
the
air
above
and
near
water,
and
where
the
weather
conditions
will
facilitate
movement
of
the
pesticide
away
from
the
water
body
to
the
target
area,
such
that
any
incidental
deposition
into
the
water
body
is
minimized.
Factors
such
as
droplet
size,
application
rate,
and
height
and
speed
of
release
will
be
addressed
in
other
provisions
of
the
label.

The
Agency
believes
that
the
purpose
of
environmental
hazard
statements
for
these
pesticides,
in
general
terms,
is
to
enable
the
user
to
recognize
and
minimize
risks
in
the
context
of
carrying
out
an
effective
public
health
pest
control
program,
consistent
with
the
risks
posed
by
the
product's
use.
Protecting
public
health
from
mosquito­
borne
diseases
with
the
pesticides
now
available
often
involves
some
degree
of
ecological
risk.
The
Agency
concludes,
however,
that
the
public
interest
would
generally
be
better
served
in
terms
of
health
protection
if
ULV
mosquito
control
pesticides
can
be
applied
in
a
manner
consistent
with
commonly
accepted
vector
control
practices,
rather
than
under
widely
varying
limits
that
now
appear
on
some
products.
It
also
follows
that
environmental
hazard
statements
need
to
be
as
clear
as
possible
in
order
to
identify
the
Page
8
potential
risks
that
applicators
are
expected
to
avoid.
When
necessary,
according
to
our
regulations
and
based
on
the
results
of
studies
conducted
by
the
applicant/
registrant,
the
Agency
will
retain
the
general
statement
that
these
products
are
toxic
to
aquatic
organisms,
but
believes
that
it
is
also
useful
to
add
less
abstract
language,
such
as
"
toxic
to
fish,
crustaceans,
and
oysters,"
if
the
Agency
has
information
showing
that
to
be
the
case.
These
are
intended
to
be
general
statements
about
types
of
organisms
and
not
refer
to
specific
species,
such
as
rainbow
trout
or
bluegill,
which
may
have
been
tested
under
laboratory
conditions
in
order
to
determine
toxicity
levels.
Proper
application,
including
mitigation
measures
for
mosquitocides
and
similar
applications
noted
above,
i.
e.,
droplet
size,
wind
direction
and
speed,
application
rate
and
height
and
speed
of
release,
can
reduce
and/
or
avoid
potential
toxic
effects.
Warnings
about
types
of
organisms
should
be
consistent
for
products
based
on
a
particular
active
ingredient,
and
the
Agency
will
identify
the
appropriate
general
types
of
organisms
for
registrants
to
include
at
the
time
labels
are
amended.

Based
on
all
of
these
considerations,
the
Agency
recommends
the
model
environmental
hazard
statement
embodied
in
recommendation
#
3
for
mosquito
adulticides.
(
Note
that
the
parts
of
this
statement
concerning
bee
protection
and
consultation
with
state
agencies
are
the
subject
of
additional
recommendations
in
this
Notice,
and
are
represented
here
with
a
placeholder
in
brackets).

Recommendation
3.
"
This
pesticide
is
[
toxic/
extremely
toxic]
to
aquatic
organisms,
including
[
insert
general
types
of
organisms].
Runoff
from
treated
areas
or
deposition
of
spray
droplets
into
a
body
of
water
may
be
hazardous
to
[
insert
general
types
of
organisms].
[
If
appropriate,
insert
any
additional
wildlife
hazard
statements].
[
Bee
precaution
can
be
inserted
here
or
as
a
third
paragraph
of
this
section
of
the
label].
[
Insert
consultation
with
state/
tribal
agency
statement].

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
."

Issue
4.
Users
should
consult
with
the
State
or
Tribal
lead
agency
for
pesticide
regulation
to
determine
if
permits
or
other
regulatory
requirements
exist.

State
and
Tribal
agencies
often
have
specific
information
about
sensitive
areas
in
terms
of
species
habitats,
drinking
water
sources
and
other
factors,
and
may
require
specific
protective
measures
through
permits
or
other
regulations.
Obligations
imposed
on
applicators
by
a
State
or
Tribal
regulation
do
not
depend
on
whether
there
is
any
notice
of
them
on
a
pesticide
label,
nor
can
a
pesticide
label
create
a
new
role
for
a
state
(
or
federal)
agency
if
they
do
not
already
have
one
under
existing
laws
and
regulations.
The
Agency
does
not
believe
it
is
appropriate
for
the
label
to
create
an
obligation
for
applicators
to
consult
state/
tribal
pesticide
agencies,
but
it
is
reasonable
that
Page
9
applicators
be
advised
of
the
possibility
of
additional
requirements,
since
this
promotes
compliance
with
measures
to
protect
the
environment.

Current
labels
are
inconsistent
in
referring
the
user
to
state
authorities.
Some
labels
are
silent
on
the
matter,
others
mention
"
applicable
state
and
federal
regulations",
and
others
instruct
the
user
to
consult
the
State's
Fish
and
Wildlife
Agency.
Some
labels
do
instruct
users
to
consult
the
State
or
Tribal
agency
responsible
for
pesticide
regulation,
which
the
Agency
believes
is
the
better
approach.
States
differ
widely
in
terms
of
agency
roles
in
protecting
environmental
and
wildlife
resources,
so
no
single
term
like
"
Fish
and
Wildlife
Agency"
is
universally
appropriate.
The
Agency
concludes
that
the
most
reliable
source
of
information
on
whether
there
are
additional
requirements
for
mosquito
control
is
the
lead
agency
for
pesticide
regulation.
Although
the
pesticide
agency
is
often
not
the
permitting
authority,
they
will
generally
know
if
such
regulations
exist
in
their
state
or
tribe,
and
who
administers
them.
The
Agency
concludes
that
the
following
statement
is
appropriate
for
all
wide­
area
mosquito
control
product
labels.

Recommendation
4.
"
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."

Issue
5.
Labels
need
to
specify
the
appropriate
spectrum
of
ULV
spray/
fog
droplet
sizes,
and
indicate
that
droplet
size
must
be
determined
according
to
directions
from
the
equipment
manufacturer
or
vendor,
pesticide
registrant
or
a
facility
using
laser­
based
measurement
methods.

Effective
use
of
mosquito
adulticides
depends
on
proper
application
rates
delivered
in
the
appropriate
droplet
spectrum.
Current
labels
vary
greatly
in
the
level
of
detail
instructing
the
user
on
what
droplet
size
spectrum
to
use
and
how
to
achieve
a
particular
droplet
size
spectrum.
While
some
labels
simply
specify
a
droplet
size
spectrum,
others
appear
to
make
the
user
responsible
for
selecting
the
appropriate
droplet
size.
Because
droplet
size
is
a
critical
parameter
in
defining
efficacy
and
risk
to
non­
target
organisms,
the
Agency
believes
that
droplet
size
affording
good
efficacy
and
low
risk
should
be
specified
on
product
labels
and
applicators
should
regularly
evaluate
the
performance
of
their
equipment.
The
appropriate
range
of
droplet
sizes
may
vary
somewhat
from
one
formulation
to
another,
so
registrants
should
propose
the
acceptable
droplet
size
range
for
their
individual
products.
Many
methods
are
available
for
evaluating
equipment
performance,
including
methods
described
in
state
sponsored
training
sessions,
published
by
mosquito
control
organizations,
and
in
a
few
cases,
by
pesticide
registrants
as
part
of
labeling.
The
Agency
believes
that
equipment
used
for
mosquito
control
must
be
evaluated
at
least
once
a
year
using
sound
methods
supported
by
states,
professional
organizations
or
registrants.
Also,
since
ground­
based
and
aerial
application
equipment
and
conditions
are
different,
the
Agency
believes
application
directions
would
be
more
clear
if
requirements
for
ground
and
aerial
applications
were
identified
in
separate
paragraphs
with
appropriate
headers.

The
Agency
believes
the
most
reliable
approach
for
calibrating
application
equipment
to
Page
10
produce
specified
size
spectra
is
for
the
applicator
to
follow
equipment
manufacturer
directions
for
droplet
size
or
to
rely
on
directions
from
a
facility
using
laser­
based
measurement
methods
(
i.
e.
laser
diffraction,
phase
doppler
or
imaging).
The
Agency
acknowledges
that
many
applicators
prefer
to
have
flexibility
in
choosing
droplet
size
spectra
appropriate
for
their
specific
treatment
areas.
The
recommended
language
below
provides
an
upper
bound
requirement
for
droplet
size,
allowing
applicators
to
use
finer
sprays
when
necessary.
Identifying
an
allowable
range
of
droplet
spectra
also
allows
the
Agency
to
estimate
downwind
airborne
concentrations
and
deposition
levels
of
adulticide
sprays
for
risk
assessment
purposes.
The
following
language
is
recommended
as
a
model
for
droplet
size
calibration
instructions
on
adulticide
labels.

Recommendation
5.
"
Ground­
based
application:
Spray
equipment
must
be
adjusted
so
that
the
volume
median
diameter
is
less
than
[
X
=
value
to
be
provided
by
registrant]
microns
(
Dv
0.5
<
X
um)
and
that
90%
of
the
spray
is
contained
in
droplets
smaller
than
[
Y
=
value
to
be
provided
by
registrant]
microns
(
Dv
0.9
<
Y
um).
Directions
from
the
equipment
manufacturer
or
vendor,
pesticide
registrant
or
a
test
facility
using
a
laser­
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
[
A
=
value
to
be
provided
by
registrant]
microns
(
Dv
0.5
<
A
um)
and
that
90%
of
the
spray
is
contained
in
droplets
smaller
than
[
B
=
value
to
be
provided
by
registrant]
microns
(
Dv
0.9
<
B
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.
Application
equipment
must
be
tested
at
least
annually
to
confirm
that
pressure
at
the
nozzle
and
nozzle
flow
rate(
s)
are
properly
calibrated."

Issue
6.
Precautionary
language
to
protect
bees
should
have
a
provision
to
allow
mosquito
control
applications
that
might
otherwise
be
prohibited
in
order
to
respond
to
immediate
threats
to
public
health.

Applications
for
adult
mosquito
control
are
generally
made
in
the
evenings,
at
night,
or
in
the
early
hours
of
the
morning
 
the
periods
when
most
mosquito
species
are
active.
These
are
the
periods
of
the
day
when
bees
are
not
active,
so
mosquito
control
applications
usually
do
not
pose
a
serious
threat
to
bees,
nor
do
they
conflict
with
bee
precautionary
language
which
prohibits
applications
"...
to
blooming
crops
or
weeds
if
bees
are
visiting
the
treatment
area."
In
some
circumstances,
however,
public
health
protection
may
require
daylight
treatments
which
could
include
areas
being
visited
by
bees.
For
example,
the
widespread
flooding
caused
by
Hurricane
Floyd
in
1999
caused
a
mosquito
and
fly
population
explosion
that
threatened
public
health
and
Page
11
required
extremely
large
area
applications
by
military
aircraft.
These
applications
were
made
in
daylight
for
safety
reasons.
There
are
also
some
mosquito
species
that
do
feed
during
the
day
and
can
be
vectors
for
West
Nile
Virus
and
other
diseases.
If
those
species
are
numerous
at
a
time
when
human
or
animal
disease
cases
have
occurred
in
the
region,
daylight
applications
may
be
appropriate
in
spite
of
increased
risk
to
bees.

The
Agency
believes
that
provision
should
be
made
to
allow
public
health
considerations
to
override
a
strict
interpretation
of
bee
precaution
label
language,
and
that
the
determination
to
make
this
unusual
type
of
application
needs
to
be
linked
to
specific
evidence
of
a
health
threat.
The
Agency
recognizes,
however,
that
it
is
not
possible
or
appropriate
to
try
to
define
a
specific
threat
level
on
a
pesticide
label.
In
its
guidance
for
West
Nile
Virus
programs,
CDC
points
out
that
many
local
variables
affect
the
seriousness
of
a
health
threat,
and
no
specific,
quantified
thresholds
for
number
or
types
of
cases
or
similar
factors
would
be
appropriate
for
all
situations.
The
Agency
also
does
not
believe
the
label
should
try
to
limit
the
authority
to
evaluate
threats
to
a
particular
state
or
local
agency,
since
these
have
widely
variable
technical
capabilities
and
legal
authorities
across
the
country.
Linking
any
extraordinary
applications
to
specific
evidence
of
a
disease
threat
helps
to
assure
pesticide
regulators
and
the
public
that
the
applications
are
warranted.
The
following
language
should
be
added
to
the
last
sentence
of
the
bee
precaution
statement
on
the
labels
of
mosquito
adulticide
products.

Recommendation
6.
"...
[
do
not
apply
to
blooming
crops
or
weeds
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."

Issue
7.
Mosquito
adulticide
labels
should
include
specific
statements
on
timing
and
frequency
of
applications.

The
Agency's
labeling
regulations
at
40
CFR
156.10
(
i)(
2)(
vii)
state
that
directions
for
use
shall
include
"[
T]
he
frequency
and
timing
of
applications
necessary
to
obtain
effective
results
without
causing
unreasonable
adverse
effects
on
the
environment."
With
very
few
exceptions,
however,
mosquito
adulticide
labels
direct
the
user
to
"
repeat
as
necessary"
and
do
not
specify
an
interval
between
treatments,
or
any
limitation
on
the
number
of
treatments
to
the
same
site,
and
this
poses
several
problems.
"
Repeat
as
needed"
clearly
does
not
meet
the
intent
of
the
regulation
by
indicating
to
users
or
enforcement
agencies
what
is
an
acceptable,
efficacious,
and
safe
application
frequency,
and
it
may
lead
to
overuse
and
increased
risks.
It
also
impedes
the
Agency's
ability
to
conduct
risk
assessments
for
the
pesticides
involved,
since
there
is
no
clear
starting
point
for
estimating
use
and
exposure.
For
risk
assessment
purposes
the
Agency
would
ideally
like
to
know
the
maximum
number
of
applications
in
a
year,
since
some
endpoints
of
concern
may
have
cumulative
or
chronic
effects.
A
specific
limit
on
applications
provides
a
baseline
for
assessment,
Page
12
rather
than
relying
on
assumptions
about
what
may
be
"
typical"
and
"
worst
case"
use
scenarios.

The
Agency
recognizes
that
many
vector
control
agencies
utilize
Integrated
Pest
Management
(
IPM)
principles
and
mosquito
population
surveillance
data
in
determining
treatment
schedules.
The
Agency
also
recognizes
that
there
may
be
limited
health
effects
data
available
to
support
specific
interval
and
frequency
limitations
for
some
products,
since
comprehensive
reassessments
of
some
of
the
mosquito
control
pesticides
have
yet
to
be
completed.
Nevertheless,
registrants
have
data
on
the
toxicity,
environmental
fate
and
efficacy
of
their
products,
and
should
be
able
to
propose
reasonable
interval
and
frequency
limits
appropriate
to
their
individual
products.

Although
interval
and
frequency
limits
are
appropriate
for
the
adulticide
labels,
mosquito
control
is
primarily
a
public
health
concern,
and
the
Agency
does
not
believe
that
the
label
should
prevent
applications
needed
for
effective
control
unless
there
is
specific
evidence
that
finite
limitations
are
appropriate
for
a
particular
product
or
active
ingredient.
For
that
reason,
the
Agency
is
recommending
a
model
for
timing
and
frequency
statements
that
includes
the
same
provisions
for
additional
treatments
to
address
threats
to
public
health
as
contained
in
recommendation
#
6
for
the
bee
precaution.
Thus,
the
following
language
should
be
included
in
the
directions
for
use
section
of
the
label.

Recommendation
7.
"
Do
not
re­
treat
a
site
more
than
once
in
[
X
hours/
days];
no
more
than
[
Y]
applications
should
be
made
to
a
site
in
any
[
Z
weeks/
months]
or
[
one
year].
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."

IV.
IMPLEMENTATION
A.
Application
for
New
Registration
EPA
expects
that
beginning
on
the
effective
date
of
this
Notice
each
applicant
for
registration
of
new
products
labeled
for
adult
mosquito
control
will
adopt
the
recommended
labeling
statements
and
principles
in
this
Notice,
to
the
extent
appropriate
for
the
product.

B.
Application
for
Amendment
EPA
requests
that
registrants
of
existing
products
covered
by
this
Notice
submit
an
application
for
amended
registration.
An
acceptable
application
for
amendment
includes
the
following
items:

!
a
completed
EPA
application
form
8570­
1;
Page
13
!
three
copies
of
the
draft
label
(
highlighting
the
changes
made
on
one
label);

!
a
description
on
the
application,
such
as,
"
Amended
consistent
with
the
guidance
set
out
in
PR
Notice
2005­
1."

All
such
submissions
must
pertain
only
to
this
PR
Notice.
Additional
unrelated
amendments
and/
or
changes
to
the
product
must
be
submitted
as
a
separate
action
or
the
submission
will
be
considered
unacceptable
and
will
not
be
reviewed.
The
Agency
will
attempt
to
process
correctly
submitted
applications
in
a
timely
manner.

The
Pesticide
Registration
Improvement
Act
of
2003
(
PRIA)
established
a
new
registration
service
fee
system
for
applications
for
registration,
amended
registration,
and
associated
tolerance
actions.
Under
this
system,
registration
service
fees
are
charged
for
covered
applications
received
by
the
Agency
on
or
after
March
23,
2004.
However,
applications
for
EPA­
initiated
amendments
are
not
subject
to
a
fee.
Therefore,
an
application
to
amend
a
registration
submitted
solely
in
response
to
this
Notice
will
be
classified
as
an
"
EPA­
initiated
amendment"
and
will
not
be
subject
to
a
registration
service
fee
provided
that
the
only
changes
being
proposed
to
the
labeling
for
the
registered
product
are
those
described
in
this
Notice.

Registrants
should
send
applications
for
amendment
to
the
following
addresses:

U.
S.
Postal
Service
Deliveries:

The
following
official
mailing
address
should
be
used
for
all
correspondence
or
data
submissions
sent
to
OPP
by
mail:

Document
Processing
Desk
(
AMEND)
Office
of
Pesticide
Programs
(
7504C)
U.
S.
Environmental
Protection
Agency
Ariel
Rios
Building
1200
Pennsylvania
Avenue,
NW
Washington,
DC
20460
Hand­
Carried/
Courier
Deliveries:

The
following
address
should
be
used
for
all
correspondence
or
data
submissions
that
are
hand­
carried
or
sent
by
courier
service
Monday
through
Friday,
from
8:
00
AM
to
4:
30
PM,
excluding
Federal
holidays:

Document
Processing
Desk
(
AMEND)
Office
of
Pesticide
Programs
(
7504C)
Page
14
U.
S.
Environmental
Protection
Agency
Room
266A,
Crystal
Mall
2
1801
S.
Bell
Street
Arlington,
Virginia
22202
V.
SCOPE
OF
POLICY
This
Notice
describes
certain
requirements
set
forth
by
FIFRA
and
its
regulations
and
provides
general
guidance
to
EPA
and
affected
parties.
While
the
requirements
in
FIFRA
and
its
regulations
are
binding
on
EPA
and
other
affected
parties,
this
Notice
is
intended
to
provide
guidance
to
EPA,
applicants,
registrants
and
the
public.
As
guidance,
this
policy
is
not
binding
on
either
EPA
or
any
outside
parties,
and
EPA
may
depart
from
the
guidance
where
circumstances
warrant
and
without
prior
notice.
Registrants
and
applicants
may
propose
alternatives
to
the
recommendations
in
this
Notice,
and
the
EPA
will
assess
them
on
a
case­
by­
case
basis.
If
a
product
does
not
meet
the
requirements
of
FIFRA
section
2(
q)
or
the
regulations
at
40
C.
F.
R.
Part
156,
the
Agency
may
find
the
product
to
be
misbranded
and
may
take
appropriate
enforcement
and/
or
regulatory
action.

VI.
EFFECTIVE
DATES
For
all
products
covered
by
this
PR
Notice:

°
The
effective
date
of
this
Notice
is
April
15,
2005.
As
of
that
date,
EPA
will
review
all
applications
for
new
pesticide
product
registrations,
amendments
to
registered
products
and
reregistration
of
registered
products
consistent
with
the
guidance
contained
herein.

°
As
of
October
1,
2005,
EPA
will
begin
to
evaluate
products
released
for
shipment
by
registrants
and
distributors
to
ensure
consistency
with
the
guidance
contained
herein.
Registrants
are
reminded
that
they
are
responsible
for
informing
their
distributors
when
they
change
their
labeling,
and
for
monitoring
the
labeling
of
their
distributors
to
assure
that
they
make
the
necessary
changes.

Various
states'
requirements
should
be
taken
into
consideration
when
deciding
on
the
timing
of
your
amendment
submission
to
EPA.
Some
states
may
require
a
review
of
the
modified
label
by
EPA
prior
to
submission
to
the
state
for
state
approval
purposes.

VII.
FOR
FURTHER
INFORMATION
For
information
on
this
Notice
contact
Jim
Roelofs
(
Telephone
703­
308­
2964;
e­
mail
roelofs.
jim@
epa.
gov.
).
Page
15
________________________________

Jim
Jones,
Director
Office
of
Pesticide
Programs