Document ID: EPA-HQ-OPP-2004-0158-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-06-01T04:00Z

­
1­
EPA
Response
to
Recommendations
from
the
SAP
Meeting
Minutes
on
Termite
Baits
from
October
16,
2002.

Docket
ID
number
OPP­
2004­
0158
Preface:
The
following
are
responses
to
the
recommendations
listed
on
page
38
of
the
SAP
Report
and
their
comments
made
in
pages
1­
37.
The
final
guideline
is
divided
into
three
sections:
laboratory
testing,
field
tests
without
existing
structures,
and
field
testing
at
existing
structures.
All
three
of
these
tests
should
be
conducted
to
evaluate
the
efficacy
of
a
termite
bait
product.
They
are
not
exclusive
from
one
another
in
terms
of
data
for
product
registration.

Response
to
the
recommendations
listed
on
page
38
of
the
SAP
report.

1.
The
guideline
lacked
clarity
and
was
too
verbose.

EPA
Response:
The
guideline
is
much
shorter
in
length
with
improved
clarity.

2.
The
guideline
need
not
specify
protocols;
only
the
data
required
to
support
claims.
Several
panel
members
recommended
that
the
guideline
allow
flexibility
with
the
choice
and
development
of
study
protocols.

EPA
Response:
The
guideline
references
a
list
of
published
studies.
Most
of
the
references
include
detailed
protocols
that
can
be
used
by
registrants
as
additional
examples
of
how
to
do
a
study.
The
guideline
provides
flexibility
and
allows
registrants
to
develop
protocols.
The
guideline
does
not
address
all
the
possibilities
for
data
generation
in
support
of
label
claims
and
is
designed
to
insure
that
the
product
can
provide
performance
as
a
termiticide.

3.
Some
members
suggested
that
a
three­
tier
system
(
laboratory,
small­
scale
field
tests,
large­
scale
field
tests)
might
not
be
necessary.
Some
believed
that
the
laboratory
and
large
scale
field
test
(
EUPs)
were
the
most
critical
for
registration.
It
was
suggested
that
the
laboratory
studies
were
more
in
the
domain
of
discovery
by
the
manufacturer
and
specific
laboratory
protocols
should
not
be
in
the
guideline.

EPA
Response:
Data
from
all
of
these
tests
are
important
to
the
understanding
of
product
performance
and
the
activity
of
a
pesticide
against
termites.
The
small­
scale
field
tests
are
necessary
in
order
to
evaluate
the
ability
of
the
bait
to
kill
termites
and
suppress
termite
populations.
Field
testing
at
residential
and
commercial
structures
provide
data
on
the
applicability
of
label
directions
and
effects
of
construction
types
and
applicators
on
bait
success.
Laboratory
testing
is
usually
part
of
the
termiticide
discovery
process
but
EPA
desires
information
on
product
toxicity,
secondary
kill,
feeding
acceptance,
and
the
basis
selecting
the
respective
active
ingredient
concentration
in
the
end­
use
bait.
The
laboratory
assays
are
conducted
under
controlled
conditions
and
clearly
enable
a
researcher
to
make
direct
observations
on
termites
and
populations.
As
a
result,
all
three
tests
have
been
retained
in
this
guideline.
These
types
of
data
­
2­
are
usually
collected
by
registrants
in
the
course
of
product
development
and
should
be
made
available
to
EPA
for
review.

4.
The
requirements
for
100%
product
performance
for
5
years
were
excessive.

EPA
Response:
The
EPA
agrees
and
the
revised
guideline
recommends
three
years
of
data.
Further,
it
is
important
to
point
out
that
this
is
a
recommendation
for
testing
and
not
a
bright­
line
performance
standard.
The
FIFRA
risk­
benefit
standard
requires
the
consideration
of
product
benefits
along
with
environmental
and
social
costs
in
determining
the
acceptability
of
a
pesticide
and
its
labeling.
Evaluation
of
bait
success
is
based
on
the
database
generated
from
the
three
tests
with
suggestions
on
evaluation
criteria.

General
Recommendations
from
the
SAP
5.
Amend
the
guideline
and
allow
for
another
period
of
public
comment.

EPA
Response:
The
guideline
has
been
amended
but
will
not
be
published
again
for
public
comment.
However,
the
Agency
did
consult
with
other
experts,
regulators,
and
stakeholders
to
receive
their
input
before
publishing
a
final
guideline.
Another
comment
period
will
delay
the
publication
of
a
final
guideline
and
the
Agency
needs
an
acceptable
test
method
in
place
for
pending
registrations.

6.
Eliminate
block/
slab
protocols
from
the
guideline.

EPA
Response:
The
EPA
agrees
and
has
removed
this
testing
regime
from
the
guideline.

7.
Clarify
and
specify
about
the
intent
and
purpose
of
each
testing
level
in
the
guideline.
Allow
flexibility
in
choosing
appropriate
treatment
protocols.
Certain
techniques
should
be
described,
but
methodologies
should
not
be
limited
to
those
contained
in
the
guideline.

EPA
Response:
We
have
clarified
our
intent
and
purpose
for
this
guideline
in
the
revised
document.
The
guideline
includes
a
disclaimer
that
clearly
allows
for
the
consideration
of
other
test
methods
or
new
technologies.

8.
Be
specific
about
the
nature
of
the
data
required
to
support
claims
intended
for
the
label.
If
for
example,
"
colony
elimination"
is
claimed,
the
registrant
should
be
required
to
demonstrate
with
a
statistically
valid
sample
size
complete
cessation
of
termite
activity
for
at
least
two
consecutive
active
periods
in
a
pre­
described
foraging
territory.

EPA
Response:
Specific
data
sets
to
support
label
claims
cannot
be
included
in
this
guideline
because
the
EPA
does
not
know
what
all
future
label
claims
will
be.
A
PR
Notice
would
be
the
­
3­
more
appropriate
vehicle
for
general
labeling
guidance
for
termite
baits
and
the
Agency
is
preparing
a
draft
notice
for
public
comment.

The
EPA
agrees
that
registrants
should
conduct
testing
and
submit
data
to
the
Agency
in
order
to
support
efficacy
claims
for
termiticides
including
termite
baits.

Response
to
other
general
SAP
comments
made
in
Pages
1­
37
of
the
report.

I.
Lab
Tests:
The
panel
criticized
the
proposed
laboratory
bioassays
but
failed
to
provide
specific
bioassays
as
a
substitute.
They
did
not
cite
any
public
literature
where
more
acceptable
methods
could
be
found.
They
recommended
that
whatever
test
design
is
used,
termites
should
be
able
to
forage
in
arenas
instead
of
jars
and
that
the
three
field
colonies
collected
for
each
species
should
provide
regional
variability.
The
test
should
be
flexible
enough
to
apply
to
testing
of
any
appropriate
life
stage.

EPA
Response:
the
EPA
made
the
requested
changes
but
we
believe
the
testing
method
of
Su
is
still
a
good
screening
tool.
We
added
statements
making
reference
to
arena
testing
and
changed
the
"
matrix"
to
that
of
the
subject
bait
product.
The
more
complicated
the
testing
the
regime,
the
more
laboratory
space
and
time
are
required.
This
results
in
increased
development
expenses.
Following
visits
to
USDA­
ARS
laboratories,
we
note
that
the
USDA­
ARS
members
of
the
SAP
use
containers
instead
of
arenas
to
evaluate
bait
activity.
On
the
other
hand,
Su
uses
jars
to
screen
bait
active
ingredient
activity
but
conducts
studies
of
foraging
behavior
in
plexiglass
arenas
set
up
in
garages.
The
EPA
acknowledges
that
we
must
be
flexible
in
our
consideration
of
laboratory
data
and
we
will
consider
alternative
testing
protocols.

The
EPA
agrees
that
the
laboratory
testing
data
for
the
active
ingredient
must
provide
the
lethal
dose
and
the
lethal
time
when
fed
upon
by
termites.
In
addition,
lab
data
should
test
whether
or
not
termites
are
repelled
by
the
active
ingredient.
Usually
this
is
done
by
exposing
termites
to
food
containing
a
range
of
active
ingredients
­
high­
to­
low.
The
concentration
of
active
ingredient
to
be
used
in
the
registered
product
should
be
readily
fed
upon
by
termites.
The
lab
data
should
demonstrate
secondary
kill,
that
is,
if
one
termite
feeds
on
the
bait,
it
should
"
transfer"
the
toxicant
to
other
termites
in
the
colony.
This
must
occur
for
a
bait
product
to
work
at
the
population
level
because
most
termites
in
the
colony
will
not
feed
on
the
bait
itself.

II.
Small
scale
field
tests.

The
panel
recommended:
­
4­
1)
using
the
population
management
field
test
(
Method
3)
only.

EPA
Response:
The
EPA
agreed
and
included
only
Method
3
test
in
this
revision.
We
retained
the
80%
as
a
suggested
performance
level
to
demonstrate
bait
success
because
it
is
the
only
level
of
success
that
appeared
acceptable
to
the
panel
and
the
termite
research
community.
It
is
important
to
note
that
while
the
guideline
calls
for
testing
to
assess
whether
the
pesticide
demonstrates
this
level
of
success,
EPA
is
not
in
this
guideline
establishing
performance
standards
and
all
products
will
be
evaluated
on
a
case­
by­
case
basis
pursuant
to
the
FIFRA
risk­
benefit
standard.

2)
The
panel
recommended
that
well
defined
termite
colonies
be
established
using
the
split
and
quartered
log
method
used
by
the
Forest
Service.
Note
that
this
method
has
also
been
used
extensively
by
Dow
AgroSciences
and
others.

EPA
Response:
The
EPA
agrees
and
has
visited
field
sites
where
this
test
has
been
implemented.
The
method
is
included
in
the
revised
guideline.

3)
Using
the
small­
scale
field
test
for
evaluating
the
activity
of
the
bait
against
termites
from
the
genus
Reticulitermes
only.

EPA
Response:
This
is
acceptable
because
the
method
has
been
field
tested
with
genus
Reticulitermes.
The
principal
structural
pests
in
the
U.
S.
belong
to
this
genus
of
termites.
This
approach
is
also
consisted
with
EPA
approved
the
EUP
performance
testing
for
DowAgrosciences
and
Syngenta
termite
bait
products.

III.
Large
Scale
Field
Tests
The
panel
recommended:

1)
100
homes
instead
of
500.

EPA
Response:
This
change
was
made
and
is
consistent
with
the
EUPs
we
have
issued
recently
for
termite
bait
products.

2)
The
panel
raised
a
concern
about
sample
size
and
statistical
analyses.

EPA
Response:
The
issue
of
sample
size
is
a
scientific
one
in
the
purest
sense
but
with
regard
to
termite
bait
registration,
the
EPA
must
also
consider
the
practicality
and
economic
concerns
in
order
to
maintain
a
regulatory
environment
based
on
"
sound
science"
yet
promoting
r"
reducedrisk
termiticide
product
development
.
The
panel
did
not
provide
a
specific
recommendation
on
how
to
calculate
the
necessary
sample
size
nor
did
they
provide
references
from
the
published
literature
for
this
information.
Field
development
of
these
products
is
difficult
due
the
lack
of
termite
research
biologists
with
expertise
in
the
design
and
performance
of
large
field
studies.
­
5­
Secondly,
the
cost
of
a
study
of
this
type
is
high,
and
if
the
experiment
is
too
large,
then
EPA
may
create
a
regulatory
environment
that
discourages
development
of
these
reduced
risk
product
applications
for
termite
control.

3)
the
panel
recommended
a
three
year
field
study
instead
of
a
five
year
field
study.

EPA
Response:
The
EPA
agreed
and
made
the
change.
Recently,
the
EPA
issued
two
termite
bait
EUPs
that
are
three
years
and
two
years
in
duration,
respectively.

4)
The
panel
recommended
remedial
testing
of
all
baits
at
termite
infested
homes
only.
Once
termites
are
eliminated
from
the
structure,
the
same
structures
is
to
be
monitored
as
a
preventive
treatments.

EPA
Response:
The
EPA
accepted
this
recommendation
and
included
it
in
the
guideline.
This
is
consistent
with
bait
application
practices
and
EPA
issued
EUPs.
However,
we
recognize
that
some
regulators
do
have
concerns
with
the
use
of
baits
as
preventive
applications
in
existing
structures
or
as
a
means
to
satisfy
pre­
construction
termiticide
treatment
requirements.
The
Agency
intends
to
address
these
topics
in
a
draft
PR
Notice
on
termite
bait
product
labeling
for
public
comment.
Likewise,
a
state
regulatory
agency
can
be
more
restrictive
than
EPA
with
regard
to
the
regulation
of
termiticides.

5)
the
panel
recommended
at
80%
level
of
product
performance
at
homes.

EPA
Response:
The
EPA
believes
this
to
be
a
realistic
level
of
performance
given
the
complexity
of
baiting
termite
populations,
however,
an
extensive
database
on
the
actual
success
of
baits
at
homes
is
not
available.
Therefore,
the
guideline
seeks
to
ensure
that
testing
under
this
protocol
is
done
to
establish
whether
the
pesticide
can
achieve
an
80%
level
of
performance
as
suggested
.
However,
any
decision
on
the
acceptability
of
submitted
product
performance
data
will
be
made
after
thorough
review
of
data
generated
with
all
three
testing
methods.
Further
discussion
of
performance
standards
and
data
supporting
label
claims
will
be
considered
for
public
comment
in
a
future
PR
Notice.

IV.
Use
DNA
markers
instead
of
mark­
recapture
studies
for
colony
identification.

EPA
Response:
A
recommended
method
was
not
included
in
the
SAP
comments.
This
begs
the
question
regarding
selection
of
the
most
applicable
mitochondrial
DNA
markers.
A
variety
of
methods
exist,
but
all
require
further
validation
in
the
study
of
field
populations.
Few
researchers
and
labs
do
this
work.
The
EPA
is
asking
registrants
to
retain
samples
for
future
analysis
when
methods
improve
and
the
cost
of
DNA
testing
is
much
less.

The
Agency
also
believes
that
testing
and
evaluation
should
place
a
greater
emphasis
on
the
presence
or
absence
of
termites
in
a
structure
together
with
the
connectivity
of
a
termite
infested
bait
station
to
termites
infesting
a
structure
to
document
the
direct
benefit
from
a
bait
application.
­
6­
V.
Return
to
the
SAP
with
a
revised
guideline
and
make
it
available
for
public
comment.

EPA
Response:
Some
members
of
the
panel
advocated
this
approach.
The
EPA
disagrees
and
will
not
conduct
another
formal
SAP.
We
believe
that
the
Panels's
recommendations
are
reasonably
clear.
EPA
work
on
recent
termite
bait
EUPs
documents
agreement
between
EPA,
the
states,
and
industry
on
acceptable
approaches
to
testing
that
are
scientifically
sound
while
satisfying
most
regulator's
concerns.

VI.
Guideline
format
was
difficult
to
follow.

The
SAP
recommended
that
the
guideline
be
organized
using
an
outline
system
of
numbers
that
are
easier
to
understand.

EPA
Response:
The
format
remains
the
same
because
it
is
consistent
with
the
EPA
published
testing
guidelines
and
the
format
for
rules
(
should
this
guideline
ever
become
part
of
a
rule).
However,
the
final
guideline
is
succinct
and
about
one­
half
as
long
as
the
original
draft.