Document ID: EPA-HQ-OPP-2005-0030-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-03-07T05:00Z

1
Summary
of
Response
to
Comments
on
Mosquito
Labeling
PR
Notice
This
document
provides
an
overview
of
the
principal
comments
received
on
the
Pesticide
Registration
(
PR)
Notice,
and
the
responses
the
Agency
workgroup
made
to
them
in
terms
of
changes
to
the
recommendations
and
to
the
discussion
in
the
final
Notice.
Changes
made
by
the
workgroup
were
subject
to
review
and
concurrence
by
EPA's
Office
of
Pesticide
Programs,
Office
of
Enforcement
and
Compliance
Assurance,
Office
of
Water,
Office
of
General
Counsel,
and
the
EPA
Regional
Offices.

Overview:

89
comments
were
received.
Over
half
are
from
private
citizens,
and
virtually
all
of
those
are
identical
and
based
on
a
model
letter
put
on
the
Internet
by
an
environmental
group.
Several
beekeepers
and
three
associations
representing
beekeepers
commented
specifically
on
recommendation
number
6.
Most
of
the
private
citizen
letters,
as
well
as
environmental
groups
who
co­
signed
a
comment
letter
submitted
by
the
group
Beyond
Pesticides,
generally
oppose
the
PRN
proposals
as
potentially
increasing
risks
to
the
environment.

Comments
were
also
received
from
5
State
pesticide
regulatory
agencies,
the
Association
of
American
Pesticide
Control
Officials,
the
American
Association
of
Pesticide
Safety
Educators,
the
American
Mosquito
Control
Association,
and
8
local
mosquito
control
agencies.
These
organizations
generally
support
the
proposals,
although
some
of
them
suggested
changes
to
the
recommendations.
Three
individual
pesticide
registrants
and
one
industry
association
(
Responsible
Industry
for
a
Sound
Environment)
also
commented.

Comment
Summary
by
Recommendation
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."
[
Unchanged]

This
was
the
least
controversial
recommendation.
No
one
opposed
the
idea
that
mosquito
control
applicators
should
be
adequately
trained
and
supervised.
A
few
commenters
wanted
clarification
of
the
responsibility
of
a
supervisor.
The
discussion
section
now
states
that
the
concept
of
supervision
here
should
be
similar
to
the
definition
of
"
under
the
direct
supervision
of
a
certified
applicator"
in
FIFRA
itself
 
i.
e.,
that
an
appropriately
trained
person
is
responsible
for
any
nontrained
applicators,
but
need
not
be
physically
present
at
the
time
of
an
application.

Recommendation
2.
"
Products
labeled
for
wide­
area
adult
mosquito
control
should
not
include
container
labeling
for
uses
unrelated
to
mosquitos.
The
standard
terrestrial
use
water
hazard
2
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."
[
Unchanged]

Regulatory
officials,
pesticide
educators
and
vector
control
agencies
all
strongly
support
the
view
that
products
should
be
labeled
solely
for
mosquito
control.
Some
of
the
pesticide
registrants
disagreed
and
stated
that
this
would
be
an
economic
burden
to
them
and
they
might
not
adopt
this
recommendation.
Registrants
did
agree
that
clear
demarcation
of
mosquito
directions
from
any
other
use
directions
was
appropriate.
The
workgroup
notes
that
among
the
most
widely
used
adulticides,
most
are
already
labeled
for
mosquito
control
only.
The
Agency
did
not
change
the
recommendation
or
the
discussion
of
this
issue.

Recommendation
3.
"
This
pesticide
is
[
toxic/
extremely
toxic]
to
aquatic
organisms,
including
[
insert
types
of
organisms].
Runoff
from
treated
areas
or
deposition
of
spray
droplets
into
a
body
of
water
may
be
hazardous
to
[
insert
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].
[
Unchanged]

"
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
those
areas
where
adult
mosquitos
are
present,
and
weather
conditions
will
result
in
movement
of
applied
material
to
the
target
area.
Do
not
contaminate
bodies
of
water
when
disposing
of
equipment
rinsate
or
washwaters
."
[
Modified
by
workgroup
to
add
the
weather
condition
language]

The
first
part
of
this
recommendation
 
on
hazards
to
aquatic
organisms
 
was
misunderstood
by
the
environmental
group
commenters.
They
thought
that
the
Agency
was
proposing
to
eliminate
the
statement
"
toxic
to
aquatic
organisms"
and
require
only
warnings
concerning
specific
species
that
had
been
tested.
In
fact,
the
recommendation
as
proposed
in
the
draft
does
include
the
statement
"
toxic
to
aquatic
organisms",
and
only
proposes
to
add
general
types
of
organisms
such
as
fish
or
crustaceans
because
these
are
more
readily
understood
warnings
than
the
abstract
"
aquatic
organisms."
Some
registrants
also
thought
we
meant
to
list
specific
test
species,
and
wondered
if
that
meant
species
for
which
they
had
generated
data.
The
Agency
does
not
want
to
list
specific
species,
but
intends
to
point
out
to
registrants
at
the
time
of
label
amendment
that
for
a
particular
active
ingredient
we
do
have
information
on
types
of
organisms
such
as
fish,
crustaceans,
etc.
(
if
that
is
the
case),
and
those
should
be
listed
as
part
of
the
toxicity
statement.
Language
has
been
added
to
the
discussion
section
to
clarify
these
points.

The
provision
to
allow
applications
over
water
was
supported
by
regulatory
and
vector
control
agencies
and
pesticide
safety
educators
as
an
improvement
that
would
allow
appropriate
applications
that
might
otherwise
appear
to
be
prohibited
by
some
current
labels.
The
Agency
accepted
suggestions
to
add
a
reference
to
weather
conditions
that
would
help
ensure
accurately
3
targeting
infested
areas,
and
minimize
the
potential
for
depositing
residues
in
water.
These
modifications
support
the
intent
of
this
recommendation.

The
environmental
group
comments
argue
that
this
recommendation
weakens
existing
protections,
such
as
the
100­
foot
buffer
zone
for
permethrin
and
"
avoid
application
over
water"
on
the
resmethrin
label.
The
Agency
view
is
that
the
flexibility
to
apply
pesticides
near
or
over
water
when
that
is
necessary
to
reach
mosquitos
is
a
significant
benefit,
and
that
such
applications
can
be
made
without
posing
unreasonable
risks
to
aquatic
life.
Mitigating
risks
to
water
and
aquatic
life
in
a
mosquito
control
application
depends
on
minimizing
deposition
of
droplets
to
water
by
controlling
for
such
factors
as
droplet
size,
application
rate,
height
and
speed
of
release,
and
wind
direction.
As
noted
in
the
PR
Notice,
the
permethrin
buffer
zone
was
primarily
intended
to
minimize
runoff
from
agricultural
applications
where
significantly
higher
rates
are
applied
compared
to
mosquito
control.
The
Agency
agreed
that
label
amendments
that
come
in
as
a
result
of
this
Notice
should
be
evaluated
to
ensure
that
any
new
label
does
not
increase
risks
compared
to
the
existing
label.
Language
was
added
to
make
this
point
in
the
final
Notice.

The
environmental
group
comments
also
advocate
regulation
of
mosquito
control
programs
under
the
Clean
Water
Act.
Presumably,
the
intent
is
to
a
suggest
a
requirement
for
permits
under
the
National
Pollution
Discharge
Elimination
System
(
NPDES).
In
that
regard,
the
Agency
has
issued
an
interpretative
statement
and
proposed
a
rule
concerning
NPDES
permits
in
relation
to
certain
pesticide
applications
(
January
2005).
As
in
the
Agency's
memorandum
of
July
2003,
entitled
"
Statement
and
Guidance
on
Application
of
Pesticides
to
Waters
of
the
United
States
in
Compliance
with
FIFRA"
,
the
2005
interpretative
statement
and
associated
proposed
rule
cite
application
over
or
near
water
for
adult
mosquito
control
as
one
of
the
types
of
pesticide
application
that
the
Agency
believes
does
not
require
NPDES
permits,
provided
the
application
is
in
accordance
with
the
label.

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."
[
Modified
by
workgroup
 
"
permits
or"
is
deleted]

Most
of
the
regulatory
and
vector
control
commenters
support
this
recommendation
as
the
most
reliable
way
for
a
pesticide
applicator
to
get
information
about
other
requirements
that
may
exist
in
a
state.
By
being
advisory
it
does
not
create
a
record­
keeping
burden
on
applicators
that
would
be
difficult
if
not
impossible
to
enforce.
A
number
of
commenters
suggested
deleting
the
word
"
permits"
which
could
cause
confusion
because
of
its
association
with
the
NPDES
permitting
issue.
"
Other
regulatory
requirements"
is
sufficient
to
cover
any
type
of
requirement
a
state
may
have.

The
group
Beyond
Pesticides
appears
to
believe
that
this
provision
relaxes
current
requirements
and
removes
accountability
of
applicators.
In
fact,
the
current
situation
is
that
many
labels
do
not
advise
the
user
to
consult
anyone,
and
of
those
labels
that
do
advise
consultation
with
a
state
or
tribal
agency,
many
are
useless
because
the
agency
named
such
as
"
the
State
Fish
and
Wildlife
4
Agency"
actually
has
no
role
in
regulating
mosquito
control.
The
Notice
points
out
that
if
a
state
does
have
regulatory
requirements
in
addition
to
the
label,
an
applicator
is
fully
responsible
for
compliance
 
it
is
not
the
pesticide
label
that
creates
the
obligation,
it
is
the
applicable
state
law.
Conversely,
a
pesticide
label
can
not
create
a
new
role
for
a
state
agency
if
they
do
not
have
it
under
state
law.
The
Agency
believes
the
recommendation
as
drafted
is
useful
and
will
promote
compliance
with
environmental
regulations.

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
µ
m)
and
that
90%
of
the
spray
is
contained
in
droplets
smaller
than
[
Y
=
value
to
be
provided
by
registrant]
microns
(
Dv
0.9
<
Y
µ
m).
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
µ
m)
and
that
90%
of
the
spray
is
contained
in
droplets
smaller
than
[
B
=
value
to
be
provided
by
registrant]
microns
(
Dv
0.9
<
B
µ
m).
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."
[
Substantially
revised
by
workgroup].

Over
twenty
regulatory
and
vector
control
organizations
and
registrants
commented
on
this
technical
issue
which
the
Agency
regards
as
an
important
label
improvement
for
ensuring
safe
and
effective
mosquito
control
and
for
supporting
Agency
risk
assessments
for
this
use
pattern.
Many
commenters
suggested
separate
statements
for
ground
versus
aerial
application,
and
several
encouraged
the
inclusion
of
a
calibration
requirement.
The
revisions
are
meant
to
accommodate
these
ideas
and
to
make
language
communicating
droplet
size
consistent
with
the
industry
standard.

A
number
of
commenters
suggested
that
this
aspect
of
labeling
should
remain
flexible
and
that
further
discussions
and
interaction
with
the
Agency
would
be
useful.
The
Agency
believes
that
going
forward
with
the
revised
recommendation
will
help
to
improve
labeling
substantially
and
that
this
language
can
be
the
basis
for
additional
improvements
in
the
future
and
should
not
be
viewed
as
proscribing
further
developments
or
interactions
between
EPA
and
the
regulated
community.
5
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
mosquitos
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."
[
Modified
by
workgroup].

In
the
draft
Notice
issued
for
comment,
the
basis
for
such
applications
was
stated
in
terms
of
the
entities
who
could
declare
a
threat
to
public
health:

[
do
not
apply
to
blooming
crops
or
weeds
when
bees
are
visiting
the
treatment
area],
except
when
applications
are
made
to
prevent
or
control
an
imminent
threat
to
public
and/
or
animal
health
declared
by
state,
tribal
or
local
health
or
vector
control
agency,
or
if
specifically
approved
by
the
state
or
tribe
during
a
natural
disaster
recovery
effort."

This
recommendation
was
generally
opposed
by
environmental
groups
and
individual
beekeepers
and
supported
by
regulatory
and
vector
control
agencies.
The
American
Beekeeping
Federation
is
willing
to
allow
a
public
health
exemption,
but
only
if
the
decision
authority
is
at
the
level
of
a
state
health
department,
and
not
local
entities.

The
general
issue
is
how
or
by
whom
a
decision
can
be
made
to
make
exceptional
applications.
The
Agency
workgroup
agreed
to
accept
the
suggestions
of
commenters
who
noted
that
the
word
"
imminent"
was
too
subjective
to
be
useful,
and
that
the
word
"
declared"
sounded
like
a
formal
process
of
declaring
an
emergency
which,
typically,
is
done
by
a
state
governor.
"
Imminent"
has
been
deleted,
and
"
declared"
changed
to
"
determined."
The
workgroup
also
supported
the
many
commenters
who
felt
that
allowing
exceptional
applications
should
be
linked
to
evidence
of
disease
causing
agents
or
actual
cases
of
disease.
However,
like
CDC
in
its
guidelines
for
West
Nile
Virus
control
programs,
the
Agency
does
not
believe
it
is
appropriate
to
try
to
specify
a
national
risk
trigger
or
criterion
for
such
applications,
or
to
impose
a
single
definition
of
appropriate
decision­
making
authority
at
the
state
or
local
level.

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
mosquitos
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."
[
Same
modification
regarding
evidence
of
disease
as
for
Rec.
#
6].

This
recommendation
is
regarded
by
the
Agency
as
an
important
improvement
over
the
commonly
used
label
statement
"
repeat
as
needed."
Specifying
re­
treatment
limitations
is
consistent
with
Agency
regulations,
reduces
the
risk
of
over­
use,
and
supports
Agency
risk
assessments.
Some
registrants
argued
that
setting
such
limits
would
be
difficult
because
of
geographical/
climatic
6
variations
and
lack
of
appropriate
data.
The
Agency
believes
that
registrants
do
have
enough
efficacy
and
environmental
fate
data
on
their
individual
products
to
propose
reasonable
timing
and
frequency
limitations.
Allowing
for
exceptions
to
these
limits
may
be
justified
on
the
basis
of
specific
evidence
of
a
threat
to
public
or
animal
health.

Other
Comments
The
comments
of
a
public
interest
group
includes
a
discussion
of
their
view
that
West
Nile
virus
"...
being
an
imminent
public
health
threat
is
overstated."
They
note
that
a
relatively
low
percentage
of
people
infected
with
the
virus
develop
symptoms
of
illness,
and
there
is
a
low
fatality
rate
among
those
who
do
develop
such
illness.
The
comment
also
states
their
opinion
that
use
of
adulticides
is
probably
not
effective
in
reducing
the
incidence
of
infection
and
implies
that
use
of
the
mosquito
adulticides
may
pose
risks
greater
than
the
disease.
A
number
of
individual
commenters
also
expressed
the
general
opinion
that
pesticide
use
may
pose
greater
risks
than
West
Nile
virus
or
other
diseases.

The
Agency
regards
mosquito
control
with
either
larvicides
or
adulticides
to
be
a
public
health
use
of
pesticides,
independent
of
the
scope
of
different
disease
threats
at
any
point
in
time.
The
fact
is
that
mosquitos
can
act
as
vectors
for
a
variety
of
human
and
animal
diseases
besides
West
Nile
Virus,
such
as
eastern
equine,
St.
Louis
and
other
varieties
of
encephalitis,
dengue
fever,
and
heartworm
in
domestic
animals.
Whether
mosquito
populations
in
a
given
area
pose
a
threat
that
warrants
preventive
measures
is
a
judgment
appropriately
made
by
state
and
local
health
or
vector
control
agencies.
In
registering
these
pesticides
the
Agency
assessed
risks
to
human
health
and
the
environment
and
concluded
that
these
pesticides
could
be
used
for
mosquito
control
without
posing
unreasonable
risks.
Recent
risk
assessments
for
malathion
and
naled
did
not
indicate
unreasonable
risks
for
the
adulticide
ULV
use
pattern.
The
updated
risk
assessments
for
the
synthetic
pyrethroids
will
be
completed
in
about
one
year,
and
if
a
potential
for
unreasonable
risks
is
revealed
by
any
of
those
assessments,
the
Agency
will
take
steps
to
mitigate
the
risks.
At
this
time
the
Agency
is
not
aware
of
evidence
that
adulticide
applications
are
posing
unreasonable
risks
to
human
health
or
the
environment.
In
contrast,
the
Agency
notes
that
from
the
outbreak
of
West
Nile
virus
in
1999
through
the
end
of
2004,
the
Centers
for
Disease
Control
recorded
16,615
cases
of
human
illness
with
651
deaths,
making
this
among
the
most
serious
vector­
borne
diseases
to
strike
the
United
States
in
modern
times.

A
commenter
expressed
concern
for
possible
impacts
of
mosquito
control
applications
to
endangered
species
which
have
not
been
systematically
assessed.
The
Agency
notes
that
it
is
now
in
the
process
of
implementing
procedures
to
include
endangered
species
assessments
as
an
integral
part
of
registration
and
reregistration
decision
processes.