Document ID: EPA-HQ-OPP-2002-0231-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-02-11T05:00Z

Pesticide
Program
Dialogue
Committee
Transcript
of
Meeting
on
May
9
&
10,
2002
at
Georgetown
University
Conference
Center
Excerpt
to
Include
Presentation
and
Discussion
Concerning
Section
18
Reform
on
May
10,
2002
what
we
said
would
be
tolerance
reassessments
under
a
theory
of
early
noncontributors
to
the
cumulative
risk.
So
it's
the
first
group
of
the
OP
tolerances
that
are
not
revoked,
but
are
deemed
by
us
to
be
reassessed.
It
covers
275
of
the
approximately
1,050,
give
or
take
­­
at
one
time
I
thought
it
was
1066,
but
it
turns
out
that's
not
the
exact
number.
So
it
covers
275
of
over
a
thousand
OP
tolerances.
So
you
can
read
that
at
your
leisure.
And
it
demonstrates
our
belief
that
it
is
possible
to
reassess
certain
of
the
OP
tolerances
prior
to
completion
of
risk
­­
a
final
cumulative
risk
assessment
and
risk
management.
But
it
is
based
on
consideration
of
cumulative
risk
as
well
as
the
individual
chemical
risk.
So
you
can
have
that.
And
finally,
but
definitely
not
least,
I
wanted
to
on
behalf
of
all
of
us
and
the
committee
thank
Adam
Sharp
and
Burleson
Smith
for
the
time
they
spent
with
us
yesterday
and
for
coming
back
and
hanging
out
with
us
again
today.
I
think
it
means
a
lot
to
the
committee
and
its
members,
as
well
as
to
us,
the
career
leadership
in
the
program,
to
have
their
advice
and
availability,
and
to
offer
both
of
them
a
chance
to
say
a
quick
hello
to
you
before
we
plunge
into
the
agenda.
MR.
SHARP:
All
I
heard
was
there
were
good
discussions
yesterday
afternoon.
I'm
looking
forward
to
hearing
a
little
more
about
some
of
the
things
that
got
discussed
yesterday,
and
especially
this
morning
on
the
Section
18'
s.
I
guess
this
is
the
­­
this
is
something
I
mentioned
yesterday,
and
it
is
a
very
important
program,
of
course.
And
I'm
looking
forward
to
hearing
the
discussion
on
the
Section
18'
s,
because
I
guess
in
my
former
life
I
know
how
important
the
Section
18
process
is
for
all
those
involved.
And
all
those
involved
being
all
those
around
the
table
and
many,
many
folks
across
the
country
who
depend
on
it.
So
I
look
forward
to
definitely
hearing
your
remarks
and
taking
a
lot
of
notes.
You'll
see
me
scribbling
a
lot
of
notes.
I'm
a
notetaker.
I
love
to
listen
to
what
people
have
to
say,
more
so
than
­­
more
so
than
always
giving
my
opinion.
So
in
that
note,
you'll
see
me
taking
a
lot
of
those
notes
and
bouncing
ideas
back
off
of
you
during
breaks
and
everything
else.
So
I
look
forward
to
working
with
you
on
this
process.
Thanks.
Burleson?
MR.
SMITH:
I
was
going
to
say
I
really
don't
have
any
comments
to
make,
other
than
I
certainly
found
a
lot
of
very
spirited
discussion
yesterday.
I
appreciated
that.
I'm
sorry
that
I
missed
the
follow
on
to
the
biopesticide
area,
but
I
look
forward
to
hearing
more
about
it.
The
one
thing
I
would
like
to
say
is
I
would
be
happy
to
make
myself
available,
since
I
was
not
around
yesterday
during
the
follow
up,
to
listen
to
any
perspective
you
may
have.
I'm
certainly
interested
in
hearing
more
individually,
and
I
hope
to
get
the
chance
to
talk
with
more
of
you
during
some
of
the
break
sessions
today.
MS.
MULKEY:
Thank
you.
And,
Jay,
you
can
catch
up
on
what
I
said
about
the
funding.
MR.
VROOM:
I
heard.
MS.
MULKEY:
Okay,
good.
MR.
VROOM:
Three
times.
MS.
MULKEY:
All
right,
great.
Very
good.
Well,
let's
move
then
into
the
Section
18
reform.
And
Pete
Caulkins
is
going
to
be
our
segment
Chair
and
work
us
through
this
session.
MR.
CAULKINS:
Thanks,
Marcia.
For
the
next
hour
and
15
minutes
we're
going
to
talk
about
the
Section
18
proposed
reform.
There
are
three
of
them.
My
panel
members
are
Rob
Forrest,
who
is
Chief
of
the
Minor
Use,
Inerts
&
Emergency
Response
Branch
in
the
Registration
Division.
To
my
right,
I
have
Dave
Widawsky.
He's
Chief
of
the
Economic
Analysis
Branch
in
the
Biological
&
Economic
Effects
Analysis
Division.
To
his
right
is
Robin
Rosenbaum.
She
is
from
the
Michigan
Department
of
Agriculture.
She's
the
Program
Manager
for
their
Pesticide
Registration
Program,
and
she
also
chairs
the
AAPCO
work
group
on
Section
18
reforms.
She
will
be
representing
sort
of
state
perspectives
on
this.
Bill
Tracy
is
here
as
a
cotton
and
carrot
farmer
in
Butingwell,
California.
He
will
be
representing
the
growers
perspective.
And
Adam
Goldberg
here
is
going
to
be
­­
from
the
Consumers
Union
will
be
representing
the
public
interest
perspective
on
this.
The
format
is
going
to
be,
we're
going
to
walk
through
some
of
the
most
recent
trends
in
the
Section
18
program
­­
Rob
will
be
doing
that
­­
and
walk
through
the
three
proposed
reforms.
Then
I'll
go
to
my
panel
members
for
comments,
and
then
we'll
open
it
for
comments
and
questions
from
all
of
you.
Rob?
MR.
FORREST:
Thanks.
There
are
three
proposed
reforms
that
we're
going
to
be
discussing
today.
The
first
is
renewable
exemptions.
Second
is
exemptions
for
resistance
management.
And
the
third
is
defining
economic
loss.
And
before
I
get
into
the
specifics,
I
first
want
to,
as
Pete
said,
go
over
some
of
the
trends
that
have
occurred
in
the
Section
18
program
over
the
last
six
years,
as
well
as
I
would
like
to
give
you
some
background
information
explaining
why
we're
talking
about
these
three
particular
reforms.
When
we're
dealing
with
the
Section
18
program,
I
think
a
good
place
to
start
is
to
discuss
volume.
This
graph
depicts
the
receipts
that
we
have
had
on
a
yearly
basis
for
the
last
six
years.
Nineteen
ninety
seven
was
the
first
year
of
impact,
I
should
say,
coming
from
FQPA.
Before
FQPA
our
average
receipts
were
about
400
to
450.
After
'
97
they
went
up
substantially.
In
'
98
and
'
99
they
hit
about
600,
and
in
2000
they
did
start
to
decrease.
Last
year
we
ended
up
with
about
540.

Another
way
to
indicate
volume
is
to
talk
about
chemical/
crop
combinations.
To
give
you
an
example
of
a
chemical/
crop
combination,
you
might
think
about
Spinosad
on
peas,
for
instance,
and
the
multiple
requests
that
we
get
for
Spinosad
on
peas
turn
out
to
be
the
number
of
18'
s
for
that
particular
year.
Before
FQPA
our
chemical/
crop
combinations
averaged
about
160,
and
you
can
see
the
receipts
were
much
higher,
obviously.
In
'
98
and
'
99,
they
hit
about
220.
Since
'
99
they
have
again
started
to
decrease.
We're
up
to
about
190.

Section
18'
s
that
are
granted.
Although
the
trend
does
appear
that
we're
increasing
as
the
years
go
by,
the
percent
of
18'
s
that
we
grant
each
year
remains
pretty
constant
at
about
80
to
85
percent.
Denials.
The
percentage
also
has
been
pretty
constant.
About
2
to
5
percent
of
our
receipts
are
actually
denied.
The
majority
of
the
denials
are
due
to
lack
of
emergencies.
There
is
maybe
1
percent
that
we
deny
because
we
can't
make
the
safety
findings,
and
that
was
true
also
before
FQPA.

This
is
a
comparison
of
receipts
and
turnaround
time.
The
time
that
we
get
the
application
and
issue
a
decision.
Historically
our
turnaround
time,
we've
always
shot
for
50
days,
and
we've
always
felt
that
that
was
an
effective
time
frame
for
us
to
do
the
assessment
that
we
need
to
do
and
get
a
response
back
to
the
grower,
whether
that's
a
positive
or
a
negative
response.
In
1996,
the
year
before
FQPA,
we
had
a
53
day
turnaround
time.
It
was
one
of
our
best.
That
started
to
increase
by
2000­
2001.
We
got
down
to
34
days.
The
number
of
crises.
I
wanted
to
put
this
chart
in
because
before
FQPA,
we
averaged
about
60.
There
is
a
good
definition
of
crisis
in
the
background
material
that
you
have.
After
FQPA
­­
'
97,
'
98
and
'
99
­­
our
crises
went
up
to
about
125
a
year,
and
there
was
a
lot
of
criticism
from
external
groups
that
they
did
go
so
high.
And
we
took
that
very
seriously.
We
worked
very
closely
with
the
states.
And
in
2001
our
crises
was
down
to
59.

Just
some
findings
that
we
have
observed
in
2001.
The
minor
use
program,
52
percent
of
Section
18'
s
went
to
minor
use
crops.
That's
about
300
Section
18'
s
that
went
to
minor
use
crops.
Twenty­
two
percent
of
the
18'
s
were
for
conventional
reduced
risk
chemicals,
and
56
exemptions
were
eliminated
for
FY­
02
growing
season,
primarily
due
to
new
uses
and
most
of
those
new
uses
were
minor
use
crops.
This
is
a
chart
that
depicts
new
uses
versus
the
Section
18'
s
that
we
received.
There
is
a
logic
in
the
assumption
that
if
new
use
registrations
increase,
then
there
must
be
a
decrease
in
Section
18
receipts.
And
in
1995
and
'
96,
where
our
new
uses
were
about
the
same,
the
receipts
were
in
the
range
that
we
would
have
expected,
400
to
450.
However,
in
2001
our
new
uses
went
up
to
204,
and
our
receipts
were
still
relatively
high,
higher
than
we
would
like
them
to
be.
So
from
this
chart,
I
think
at
least
right
now
it's
hard
to
make
a
correlation
between
new
uses
and
how
many
Section
18'
s
we
might
eliminate
that
particular
year.
So
it
appears
that
there
is
some
progress.
There
has
been
a
decrease
in
our
turnaround
time,
there
has
been
a
decrease
in
crisis
exemptions,
and
there
has
been
a
decrease
in
the
number
of
FY­
02
Section
18'
s
due
to
new
use
registrations.
And
again,
these
were
mostly
minor
use
registrations.

So
with
such
progress,
why
reform?
Well,
a
couple
of
reasons.
Back
in
1995
there
was
a
government
wide
effort
to
streamline
regulations
and
EPA
began
to
evaluate
the
Section
18
process.
Also
around
the
same
time,
we
received
a
resolution
from
NASDA
and
AAPCO,
NASDA
being
the
National
Association
of
State
Departments
of
Agriculture
and
AAPCO
is
the
Association
of
American
Pesticide
Control
Officials.
We
received
a
letter
from
them.
Their
resolution
is
outlined
in
the
background
material.
They
supplied
eight
reforms
that
they
would
have
liked
­­
that
they
wanted
us
to
consider.
Aside
from
these
two
being
the
obvious
in
terms
of
moving
us
forward,
in
terms
of
reforms
I
would
say
that
because
of
the
nature
of
Section
18'
s,
we
need
to
respond
quickly
and,
again,
either
positively
or
negatively.
And
we're
always
looking
for
ways
to
improve
the
process
and
to
expedite
decisions,
and
that
was
one
of
the
ways
that
we
got
a
response
time
down
to
44
and
34
days.

With
the
letter
from
NASDA
and
AAPCO,
we
decided
that
in
November
of
'
96
we
were
going
to
hold
a
two
day
workshop
to
discuss
the
reforms
and
to
solicit
comments.
The
workshop
was
widely
attended.
It
was
very
much
of
a
diverse
group.
State
lead
agencies
were
represented,
environmental
public
interest
groups,
pesticide
companies
and
academia.
The
reforms
back
in
'
96
were
put
on
the
back
burner
for
a
while.
Three
months
before
the
workshop,
in
August,
FQPA
was
enacted,
and
this
certainly
changed
the
dynamic
of
the
workshop
in
that
we
spent
at
least
50
percent
of
our
time
discussing
the
impacts
of
FQPA
on
the
Section
18
program.
And
it
was
clear
at
the
end
of
that
workshop
that
the
attendees
thought
at
least
at
that
time
that
it
would
be
best
for
us
to
focus
on
addressing
the
FQPA
issues,
which
we
did.
Having
said
that,
we
tried
to
keep
the
reforms
somewhat
in
the
public
eye.
In
1999
we
put
out
a
proposed
rule
setting
tolerances
for
Section
18'
s,
and
in
that
rule
we
also
solicited
comments.
We
asked
for
comments
on
the
NASDA/
AAPCO
recommendations.
In
2001
we
began
to
refocus
on
the
reforms.
The
states
did
as
well.
AAPCO
formed
a
task
force.
We
met
with
the
task
force
back
in
August
to
discuss
the
feasibility
of
all
eight
of
the
reforms,
and
at
the
conclusion
of
the
meeting,
these
were
the
reforms
that
there
was
a
consensus
on
in
terms
of
going
forward.

So
the
first
reform
is
renewable
exemptions.
EPA
authorizes
a
Section
18
by
no
longer
than
one
year,
and
quarantine
exemptions
are
for
three
years.
This
proposal
is
that
if
certain
criteria
are
met,
the
agency
would
allow
states
to
recertify
an
emergency
situation
up
to
two
years
following
an
initial
authorization.
Why
are
we
doing
this?
Well,
approximately
70
percent
of
our
Section
18'
s
are
repeats,
and
given
the
high
level
of
repeats,
we
feel
that
this
approach
would
help
conserve
some
resources.
Certainly
the
state
resources.
And
how
would
it
work?
The
first
year
the
request
would
come
in
and
we
would
do
an
assessment.
Assuming
that
it's
a
renewable
exemption,
the
assessment
would
be
based
on
risk,
which
it
always
is
­­
dietary
­­
because
we
need
to
set
a
tolerance,
ecological,
environmental
and
occupational.
We
also
have
to
determine
progress
towards
registration.
We
also
have
to
validate
the
emergency.
And
since
this
would
be
a
renewable
exemption,
we
would
have
to
determine
whether
the
emergency
met
certain
criteria
for
a
renewable
exemption.

Possible
criteria.
The
pest
has
developed
resistance
to
alternatives
and
that's
been
documented.
Alternative
products
aren't
available
due
to
cancellation.
It
might
be
a
new
pest.
Documented
loss
of
efficacy
of
registered
alternatives.
The
key
to
these
particular
alternatives
is,
I
think,
predictability
in
that
there
is
probably
a
good
chance
that
these
requests
would
last.
The
emergency
would
persist
for
two
to
three
years.
When
would
a
renewable
exemption
be
unlikely?
A
new
crop.
Weather
related
pest
outbreak.
That's
not
to
say
that
someone
wouldn't
get
a
Section
18
because
they
had
a
lot
of
rain,
but
there
is
not
a
lot
of
predictability
that
they're
going
to
have
rain
the
next
year.
Poorly
documented
emergency
situation.
Sporadic
pest
outbreak.
Again,
there
is
not
a
lot
of
predictability
there.
Or
where
the
alternative
product
is
unavailable
due
to
a
supply
shortage.

How
would
this
process
unfold?
EPA
would
do
their
assessment,
and
at
the
end
of
their
assessment
if
we
conclude
that
this
would
be
acceptable
and
we
grant
the
exemption,
this
would
be,
again,
a
renewable
exemption
and
it
would
be
a
one
year
exemption
that
could
be
renewed
for
two
subsequent
years
pending
EPA's
review
and
approval
of
the
state's
confirmation
that
the
emergency
still
persists.
Again,
the
states
would
be
required
to
recertify
the
emergency
to
EPA
each
subsequent
year
after
the
initial
authorization.
In
terms
of
quality
controls,
recertification
of
the
emergency
would
prompt
the
agency
to
reevaluate
the
situation
each
year.
If
any
changes
in
the
status
of
the
exemption
occur,
if
we
receive
new
information,
the
agency
would
have
to
determine
how
that
new
information
would
impact
the
continued
use
of
the
exemption.
We
would
notify
the
state.
Let
them
know
what
the
changes
are
and
how
those
changes
might
impact
the
exemption.

Another
quality
control
measure
would
be
that
if
EPA
receives
new
information
at
any
point
during
the
renewable
exemption.
We
would
inform
the
states
that
recertification
is
no
longer
an
option.
If,
for
instance,
in
year
two
the
state
recertifies
the
emergency,
we
approve
it
and
six
months
later
we
have
new
information
that
impacts
the
exemption,
and
the
state
still
wants
to
consider
that
use
prior
to
the
next
growing
season,
they
would
have
to
then
submit
an
application
and
inform
the
agency
how
our
particular
argument
is
­­
makes
sense
to
them
or
not
and
how
they
would
rebut
our
arguments.
So
that's
renewable
exemptions.
Next
is
exemptions
for
resistance
management.
Currently,
the
agency's
position
is
that
Section
18'
s
may
only
be
authorized
for
resistance
management
in
cases
where
documented
pest
resistance
to
the
registered
alternative
has
already
developed
and
is
expected
to
result
in
significant
economic
losses.
The
proposed
reform
is
that
if
certain
criteria
are
met,
we
would
allow
the
issuance
of
an
emergency
exemption
for
an
alternative
to
be
used
in
conjunction
with
the
registered
pesticide,
again
where
there
is
documented
scientific
evidence
that
resistance
has
developed
to
the
currently
registered
pesticide,
even
though
the
degree
of
resistance
may
not
have
resulted
in
significant
economic
loss.

And
how
would
these
reforms
work?
As
I
mentioned,
we
would
grant
the
exemption
for
the
alternative
in
cases
where
there
is
documented
evidence
that
shows
that
resistance
is
happening
to
the
currently
registered
pesticide.
Now,
having
said
that,
criteria
would
need
to
be
established
to
provide
guidance
as
to
when
a
requested
alternative
could
be
granted
under
a
Section
18
for
reasons
of
resistance
management.
One
example
might
be
that
the
requested
pesticide
must
be
of
a
different
chemical
class,
or
a
different
mode
of
action
from
the
currently
registered
pesticide.
Specific
criteria
would
need
to
be
developed.
We're
in
the
process
of
doing
that.
Certainly,
any
ideas
that
you
might
have
regarding
criteria
to
resistance
management
would
be
most
welcome.
MR.
CAULKINS:
Thanks,
Rob.
Now,
Dave
Widawsky
is
going
to
briefly
explain
the
proposed
reform
on
defining
economic
loss.
MR.
WIDAWSKY:
Thanks.
Thanks,
Pete.
Well,
the
first
question
that
we
ask
ourselves,
and
reasonably
you
ought
to
ask
us,
too,
is
why
do
the
criteria
need
revision
for
determining
significant
economic
loss.
And
I'm
going
to
introduce
three
ideas
about
our
reasons
why
we
want
to
consider
revising
the
criteria
for
determining
significant
economic
loss.

The
first
one
is
the
point
that
Rob
made
earlier,
that
the
states
have
asked
us
to
please
think
about
are
there
ways
to
reduce
the
data
burden
that
we
currently
have
that
is
required
in
order
to
make
our
determination.
Some
of
the
states
believe
that
the
data
that
we're
requiring
can
be
onerous
and
can
take
a
fair
amount
of
time
to
collect,
and
we've
been
asked
to
reflect
on
whether
we
can
responsibly
make
our
determination
of
significant
economic
loss
with
less
data.
The
second
reason
to
consider
revising
the
current
criteria
is
a
systematic
difference
in
agricultural
production
systems
that
may
lead
to
what
we
might
call
an
unlevel
playing
field
in
some
cases.
And
I'll
talk
about
that
when
we
talk
about
the
limitations
of
the
current
criteria.
And
a
third
reason
is
that
if
we
can
actually
make
our
reasonable
determination
and
be
responsible
with
less
resources
from
the
states,
it's
also
going
to
require
the
agency
to
spend
less
resources
on
analyzing
this
data,
so
it
would
be
a
win/
win
situation
for
everybody
involved.

So
what
I'm
going
to
do,
is
I'm
going
to
quickly
recapitulate
what
are
the
current
criteria
for
determining
significant
economic
losses
and
what
are
some
of
the
limitations
of
those
criteria
in
relation
to
what
I've
just
mentioned,
and
then
talk
about
what
we
would
like
to
propose
for
new
data
requirements,
new
methods
for
determining
significant
economic
loss,
and
what
some
of
the
implications
of
this
tiered
system
of
data
would
be.
The
current
system
for
determining
significant
economic
loss
is
based
on
normal
or
observed
historical
patterns
of
crop
variations.
What
we've
been
asking
for
is
for
historical
data.
Five
years
of
data
on
the
production
of
that
crop,
the
prices
associated
with
that
and
the
cost
of
production.
And
what
we
do
with
that
is
try
to
determine
­­
we
make
a
determination
of
what
the
profit
would
­­
the
normal
profit
­­
the
historical
pattern
of
profits
would
be.

When
we
look
at
the
base
line,
we
compare
that
base
line
to
what
the
emergency
situation
would
be
in
terms
of
potential
losses
and
yield,
and
in
addition
to
losses
and
yield,
potential
changes
in
quality
from
a
particular
pest
or
insect
disease
or
weed.
And
then
how
the
­­
in
addition
to
the
potential
revenue
impacts,
what
cost
impacts
would
arise
from
changes
in
pesticide
costs,
pesticide
application
costs,
potential
changes
in
operating
costs
from
making
different
­­
using
different
equipment,
or
making
additional
applications,
or
changes
in
harvesting
costs.
And
then
we
estimate
the
level
of
profits
and
what
the
difference
in
profits
would
be.
If
the
impact
of
the
emergency
situation
leads
to
profits
that
are
outside
that
five
year
pattern
that
we
have
observed
from
the
historical
data,
then
we
make
a
determination
of
significant
economic
loss.
This
has
worked
for
us
reasonably
well,
but
there
are
some
limitations
to
this
method
for
determining
significant
economic
loss.

The
first
is
that,
as
most
agricultural
producers
can
attest,
the
profits
don't
fluctuate
the
same
for
all
crops.
My
background
is
in
agricultural
production
economics.
And
there
is
a
lot
of
data
to
suggest
that
rain
fed
crops
have
­­
because
of
the
dependence
on
­­
it
depends
on
the
rainfall
in
a
given
year,
have
profits
that
fluctuate
much
more
widely
­­
or
I
shouldn't
say
widely.
But
much
more
substantially
than
crops
that
have
a
more
controlled
water
control
system
like
irrigated
crops.
And
so
the
result
of
that
is
that
the
pattern
of
historical
variation
is
going
to
be
wider
for
rain
fed
crops
and
require
the
emergency
situation
to
lead
to
a
profit
loss
that
is
greater
in
order
to
fall
outside
that
pattern
of
historical
variation.
And
we've
been
asked
to
consider
whether
that
is
something
that
we
want
to
reform
or
consider
revising
our
criteria
in
order
to
take
that
into
account.
The
second
limitation
is
that
the
historical
data
may
be
affected
by
the
emergency
condition
if
we're
relying
on
historical
data
and
we
have
a
Section
18
situation
that
has
been
occurring
year
to
year.
Over
time
we
start
to
see
impacts
on
profits
and
costs
and
pesticide
use
that
is
incorporating
the
Section
18
exemption,
and
it
becomes
more
difficult
to
separate
out
the
emergency
condition
from
the
base
line
condition
when
we're
relying
on
historical
data.

And
third,
the
historical
data
may
not
be
available
for
minor
crops
for
five
years
in
a
lot
of
states.
Those
data
can
be
hard
to
come
by,
and
when
we
can
get
them,
they're
not
always
as
well
documented
as
we
would
like
them
to
be.
So
what
are
we
proposing?
We're
proposing
to
go
to
a
tiered
system
of
data
requirements
for
determining
significant
economic
loss.
And
the
idea
is
that
we
would
start
off
at
a
lower
tier
with
a
smaller
data
burden,
and
then
depending
on
the
findings
at
any
given
tier,
increase
the
data
requirements
as
we
go
­­
if
we
can't
make
the
determination
at
a
lower
tier.
The
first
tier
that
we
call
tier
one
is
yield
based,
and
it's
based
on
the
presumption
that
if
yield
losses
are
high
enough,
then
you
can
reasonably
make
a
determination
that
significant
economic
losses
are
going
to
occur.
If
somebody
is
anticipating
that
they're
going
to
lose
50
percent
of
their
revenues,
you
don't
have
to
get
detailed
­­
we
believe
that
you
don't
have
to
get
detailed
information
on
every
pesticide
application
to
realize
that,
hey,
that's
going
to
be
a
problem
and
we're
going
to
realize
significant
economic
losses.

And
so
that
one
of
the
challenges
becomes
how
do
you
determine
what
the
threshold
would
be,
and
that's
something
that
we're
working
on,
and
I'll
get
into
that
in
the
case
study
I'm
going
to
present
next.
But
I
just
wanted
to
introduce
that
to
you
at
this
point.
And
what
it
does,
it
allows
to
even
a
threshold
among
crops
and
so
you're
not
trying
to
downsize
the
historical
variation,
but
we're
setting
the
same
threshold
for
different
kinds
of
problem
systems.
In
some
cases,
the
economic
loss
isn't
going
to
come
from
yield
changes,
but
it
may
come
from
changes
in
the
quality
of
the
produce
­­
the
fruits
and
vegetables.
That's
often
the
case
for
emergency
situations.
And
so
in
that
case
­­
in
those
kind
of
cases,
we
would
like
to
be
able
to
go
to
a
second
tier,
and
that
considers
economic
loss
as
a
percentage
of
gross
profits.

In
that
case,
we're
taking
into
account
the
yield
loss,
but
we're
also
accounting
for
price
and
quality
effects
on
the
changes
in
pest
control
costs.
And
we
would
compare
an
economic
loss
defined
as
total
revenue
plus
changes
in
pest
control
costs
as
a
percentage
of
gross
profits,
and
that
allows
us
to
take
those
price
quality
effects
into
account,
and
make
a
determination
with
more
data
than
we
would
need
under
the
yield
based
tier,
but
still
a
lot
less
than
we
would
require
under
the
historical
variation
method.
And
then
increase
in
the
data
requirements.
If
we're
not
finding
significant
economic
loss
in
tier
one
and
tier
two
and
the
application
reports
that
there
is
an
economic
loss,
we
can
consider
a
third
tier
which
would
look
at
economic
loss
as
a
percentage
of
operating
profits.
And
that's
getting
us
closer
to
the
analysis
that
we're
doing
now
in
terms
of
data
requirements
for
the
current
year,
but
it's
basing
the
determination
on
the
base
line
versus
the
current
year
without
necessarily
going
to
a
historical
variation
method
and
setting
some
kind
of
a
threshold
or
standard
for
what
that
percentage
would
be
to
come
to
a
determination
of
significant
economic
loss.
So
those
are
our
tiers.
And
what
we
did
is
a
case
study,
taking
89
Section
18'
s
analyses
that
we
did
in
the
1998­
1999
season,
and
considering
the
analysis
that
we
did
under
the
current
criteria,
we
are
reanalyzing
those
data
under
our
tiered
system
to
see
what
would
happen
if
we
­­
would
we
get
different
answers.
Would
we
­­
are
we
completely
out
of
kilter
here
in
proposing
these.

What
we
did,
is
we
estimated
based
on
these
89
applications
what
would
be
­­
what
was
the
yield
loss
that
was
associated
with
it
and
under
the
current
system
did
it
lead
to
significant
economic
loss
or
not.
We
did
the
same
calculation
for
tier
two,
economic
loss
as
a
percentage
of
gross
profits.
And
then
also
for
tier
three,
economic
loss
as
a
percentage
of
­­
gross
profits
and
then
the
tier
three
operating
profits.
And
what
we
found
was
that
there
was
no
noticeable
difference
in
the
likelihood
of
determining
significant
economic
loss.
And
what
that
told
us
basically
is
that
we
could
use
a
lot
less
data
­­
and
require
the
states
to
provide
a
lot
less
data
­­
and
relieve
some
of
our
burden
in
making
the
determination
and
basically
come
up
with
the
same
likelihood
of
determining
significant
economic
loss.

In
a
substantial
number
of
the
cases,
about
half
the
cases,
where
there
was
a
finding
of
significant
economic
loss
under
the
historical
or
the
current
method,
yield
data
alone
would
have
sufficed
to
come
to
that
determination,
and
that
suggests
to
us
that
there
is
a
real
potential
for
reducing
the
burden
to
states
and
the
agencies
for
collecting
and
analyzing
these
data.
Now,
this
was
a
real
quick
jog
through
our
proposed
changes
for
making
significant
economic
loss
determinations.
If
you
want
more
information,
we
do
have
a
­­
there
was
a
handout
at
the
front
on
the
proposed
methodology,
and
we'll
get
a
chance
to
talk
about
it
more
in
the
discussion
section.
MR.
CAULKINS:
Thanks,
Dave.
Rob,
do
you
want
to
do
the
next
steps?
MR.
FORREST:
We're
going
to
close
with
going
over
some
next
steps.
What
we're
going
to
be
doing
is
issuing
a
proposed
Federal
Register
notice
for
public
comment.
We
hope
that
that
would
happen
in
the
summer
of
2002.
On
an
interim
basis,
we
will
be
implementing
the
reforms
in
the
2003
growing
season.
This
would
provide
us
an
opportunity
to
gain
some
experience,
to
test
what
works
and
what
doesn't
work.
At
the
same
time,
we
would
be
considering
public
comments,
and
we're
going
to
pay
very
close
attention
to
how
these
proposed
reforms
impact
on
the
Section
18
process.
After
that,
we'll
gather
up
our
experience
and
we'll
report
back
to
this
committee
and
we
will
revise
accordingly.
Okay.
Now,
I
would
like
to
have
Robin's
­­
one
of
our
panel
members
­­
presentation.
MS.
ROSENBAUM:
Thank
you.
As
Peter
said,
I
am
here
to
talk
to
you
about
the
perspective
of
the
AAPCO
Section
18
Task
Force,
and
also
the
perspective
of
the
sole
Section
18
submitter
for
the
State
of
Michigan,
which
has
particular
impact
on
this
first
Section
18
revised
procedure
recommendation.
I've
got
a
Power
Point
up
there
somewhere.
Well,
I'll
get
started.
On
the
renewable
Section
18
exemptions,
we
believe
that
EPA
should
allow
states
to
recertify
the
emergency
situation
for
the
second
or
third
year
based
upon
the
state's
confirmation
that
the
basis
for
an
emergency
situation
continues
to
exist.

Most
of
the
Section
18'
s
that
we
request
are
due
to
the
fact
that
the
registered
alternatives
are
no
longer
efficacious
or
not
efficacious
enough,
or
perhaps
there
has
been
a
cancellation
of
a
key
pesticide,
and
the
pesticide
that
we've
requested
under
Section
18
is
the
best
in
the
pipeline,
if
not
the
only
product
in
the
pipeline.
So
it's
our
feeling
that
if
the
product
doesn't
get
registered
during
the
year
in
which
we've
asked
for
the
Section
18,
then
the
urgent
situation
still
exists
in
the
subsequent
year
and
would
therefore
warrant
another
Section
18
exemption.
Another
reason
why
we
are
supportive
of
this
revised
procedure
is
that
data
from
the
current
season
are
difficult
to
obtain
early.
In
Michigan
where
we
have
a
single
growing
season,
we
harvest
into
October
and
oftentimes
it
takes,
you
know,
a
month
or
two
or
three
perhaps
for
the
growers
and
the
Extension
specialists
to
compile
the
data
necessary
to
update
the
Section
18
for
the
subsequent
growing
season.
That's
not
mine.
I'm
trying
not
to
look
at
it.
Okay.
It
just
says
PPDC,
Robin
on
there.
That's
okay.
There
are
only
six
of
them.

So,
anyway,
what
that
does
is
it
delays
my
ability
to
get
the
Section
18
into
EPA
until
perhaps
January
or
February
or
March,
when
I
barely
speak
to
anybody
else
in
the
office.
All
I
do
is
have
my
head
down
working
on
these,
and
this
year,
18
Section
18
exemptions.
So
you
can
see
that
the
timing
issue
is
a
problem,
that
by
the
time
EPA
gets
the
application
­­
and
I
had
to
put
a
plug
in
for
EPA.
I
mean,
they've
done
great
in
terms
of
streamlining
their
end
of
the
process
and
the
turnaround
has
been
great.
It's
just
that
we
can
only
get
the
applications
in
to
them
so
early.
And
this
pushes
us
right
up
against
the
growing
season,
and
oftentimes
the
situation
is
that
the
growers
don't
know
until
the
height
of
the
pest
occurrence
whether
or
not
they're
going
to
have
a
Section
18
material.
So
that
creates
some
obvious
difficulties
for
the
grower.
If
we
could
get
the
­­
if
we
could
certify
the
Section
­­
recertify
that
the
emergency
situation
continues
to
exist
and
give
the
growers
an
extension
of
heads
up
earlier,
we
would
have
a
lot
more
time
for
the
growers
to
strategize
their
spray
schedules
for
the
summer,
and
there
would
be
a
lot
more
time
for
product
stewardship.
Our
Extension
specialists
are
out
all
­­
you
know,
in
their
winter
meetings
all
year,
and
they've
sort
of
got
their
hands
tied
when
they
can't
talk
about
whether
or
not
the
Section
18
products
will
be
available
in
the
subsequent
growing
season.

So
if
we
could
recertify
in
Michigan,
for
example,
in
December
­­
or
even
January
­­
that
they're
going
to
have
the
product
in
the
upcoming
growing
season,
then
clearly
that
creates
a
much
better
situation,
and
particularly
when
you're
talking
about
resistance
management
and
development
of
a
resistance
management
plan.

And
the
obvious
one,
better
utilization
of
resources
for
the
growers,
the
Extension
specialists,
the
state
lead
agency
and
EPA.
I
think
it
would
give
us
more
time
to
focus
on
the
initial
applications
and
do
perhaps
a
better
job
of
putting
those
applications
together.
But
we're
continually
being
asked
to
do
more
with
less
and
less
and
obviously
need
to
prioritize
our
tasks.
Michigan
­­
or
the
Governor
just
announced
an
early
out
package
and
told
us
that
those
of
us
who
are
left
standing
for
the
next
20
years
can
only
rehire
one
in
four
positions.
So
we
just
lost
16
people.
We
get
four
back.
That
just
tells
you
what
our
work
environment
is
like.

And
last
but
not
least,
on
this
one,
of
course
EPA
retains
its
authority
to
rescind
or
deny
the
emergency
exemption
for
cause
should
additions
to
its
risk
database
warrant
such
a
decision.
So
there
is
always
that
fail
safe.
So
we
really
feel
that
this
is
a
win/
win
revised
procedure
recommendation.
Resistance
management.
We
feel
EPA
should
support
Section
18
exemptions
for
resistance
management
where
there
is
documented
scientific
evidence
of
resistance
to
currently
registered
pesticides
or
valid
research
demonstrates
the
dynamic
process
of
resistance
is
developing.
As
you
know,
resistance
management
is
the
process
of
prolonging
the
useful
life
of
a
pest
control
tool
by
delaying
the
selection
of
pest
populations
that
are
resistant
to
it.
Resistance
management
programs
are
seen
philosophically
in
the
context
of
integrated
pest
management,
where
in
IPM
programs
pests
are
held
below
economic
injury
levels
by
utilizing
optimum
combination
of
strategies
which
offer
the
most
minimal
adverse
effects.
To
require
growers
to
use
up
all
of
their
effective
pest
management
tools
before
the
situation
is
considered
an
emergency
as
defined
by
Section
18
regulations
seems
to
not
be
in
accordance
with
IPM.

The
future
success
of
resistance
management
depends
upon
the
continued
availability
of
a
diverse
arsenal
of
efficacious
pest
management
tools.
The
benefits
of
this
would
extend
to
the
consuming
public
and
to
the
environment
as
a
whole
through
the
increased
availability
of
wholesome
produce
at
affordable
prices
and
reduced
pesticide
load
to
the
land,
water
and
air.
And
I
have
to
throw
in
the
Colorado
potato
beetle
example
in
talking
about
reduced
chemical
load
in
the
environment.
Several
years
ago
I
put
together
Section
18'
s
for
use
of
a
few
products
for
the
Colorado
potato
beetle.
And
in
going
through
that
process,
we
surveyed
the
Michigan
potato
growers
and
asked
them
to
submit
a
list
of
the
chemicals
they
were
using
to
try
and
control
this
pest.

I
mean,
it
was
pretty
incredible
what
they
were
doing.
Basically,
we
saw
the
word
cocktail
on
their
spray
list
many,
many
times,
that
they
were
taking
several
insecticides
and
throwing
them
in
the
spray
tank
and
hopefully
some
combination
of
those
sprays
were
going
to
kill
this
persistent
pest.
So
we
eventually
obtained
the
Section
18
exemption
for
Metaclopred
and,
you
know,
hugely
reduced
the
pesticide
load
on
the
environment.
So
while
it's
unrealistic
to
expect
the
emergency
exemption
process
alone
to
provide
the
solution
to
the
pest
resistance
problem,
we
feel
that
its
judicious
use
in
a
proactive
manner
could
offer
a
significant
contribution
to
the
resistance
management
effort.
And
lastly,
significant
economic
loss.
We
feel
that
EPA
should
support
the
use
of
yield
loss
and/
or
other
economic
indicators
instead
of
or
in
addition
to
the
five
year
production
cost
averages
for
crops
with
a
high
variability.
And
I
won't
spend
a
lot
of
time
on
this
one,
since
David
did
us
such
a
nice
job
of
laying
it
out.

But
most
of
our
Section
18
exemptions
are
for
use
on
minor
crops.
Seventeen
of
the
18
I
processed
this
year
for
Michigan
alone
were
minor
crops.
Current
agency
guidance
says
that
loss
is
significant
only
if
it
exceeds
the
normal
variation
of
profits
over
a
five
year
time
frame.
States
and
growers
feel
that
this
practice
discriminations
against
minor
use
crops
with
high
variability,
because
a
much
higher
loss
is
required
to
fall
outside
of
the
normal
range
and
it
doesn't
take
into
account
a
number
of
factors
outside
the
control
of
the
grower,
which
cause
fluctuation
in
profits
and
losses
and
mask
the
emergency
nature
of
the
situation.
An
example
of
a
situation
that
wouldn't
fit
the
classic
economic
scenario
is
powdery
mildew
on
watermelons.
It
is
a
serious
late
season
disease,
where
the
disease
defoliates
the
vines
exposing
the
melons
to
sunburn.
Sun
exposure
turns
the
melons
pale,
almost
white,
resulting
in
a
poor
quality
product.
The
yield
numbers
don't
reflect
the
loss,
because
the
grower
can
still
harvest
the
sunburned
melon
crap.
The
powdery
mildew
stunts
the
plants
and
the
melons,
so
the
grower
will
feel
the
losses
in
the
grade.
Grower
pack
outs
are
the
best
way
to
analyze
crap
loss.
The
pack
outs
reveal
the
fluctuation
crap
grade
as
a
result
of
the
disease
pressure.
So
basically
that's
it.
Thank
you.
MR.
CAULKINS:
Thank
you,
Robin.
I'm
going
to
ask
Adam
Goldberg
from
Consumers
Union
now
to
provide
us
with
a
public
interest
group
perspective.
MR.
GOLDBERG:
Thank
you.
On
the
renewable
exemptions,
we
certainly
don't
want
EPA
or
the
states
to
be
wasting
any
resources.
However,
to
us
this
proposal
seems
to
be
more
about
making
it
easier
to
get
Section
18'
s
that
may
or
may
not
be
warranted.
It
is
one
thing
to
streamline
the
process,
but
not
if
it
takes
the
emphasis
away
from
the
real
reason
behind
the
Section
18
program.
Our
problem
is
that
the
whole
idea
of
Section
18'
s
is
that
they
are
for
unpredictable,
unusual
and
nonrecurring
pest
management
emergencies.
If
the
agency
is
asked
to
grant
a
two
or
three
year
Section
18
because
of
solid
evidence
showing
that
an
emergency
will
exist
for
the
next
two
or
three
years,
the
pest
problem
justifying
the
Section
18
seems
well
outside
the
definition
of
an
unpredictable
emergency.

If
the
goal
of
this
current
Section
18
reform
process
is
to
develop
a
new
category
of
temporary
limited
registrations,
let's
be
honest
and
up
front
about
it
and
retain
the
Section
18
program
as
is,
since
it
clearly
does
serve
a
vital,
although
too
pliable,
purpose.
If
there
is
a
continuing
need
for
a
particular
pesticide
to
be
used
on
a
particular
crop
year
after
year,
then
there
is
no
longer
an
emergency
use
and
the
resources
should
be
put
into
getting
a
permanent
tolerance
or
registration
in
place.
In
fact,
if
the
goal
is
efficient
use
of
resources,
why
not
speed
up
permanent
registration
for
reduced
risk,
low
exposure
products
and
uses.
If
you
look
at
the
numbers
that
were
presented,
there
are
far
too
many
Section
18'
s
granted
and
the
numbers
seem
to
be
going
up
every
year.
And
there
are
very,
very
few
denials,
and
while
the
denial
numbers
are
higher
in
2001
than
in
1996,
it's
not
an
appreciable
difference
really.
It's
a
very
small
number
of
the
overall
numbers
of
submissions.
Basically
from
our
perspective,
the
Section
18
process
has
gotten
too
routine
and
that's
really
a
problem.
EPA
should
tighten
up
the
Section
18
process.
Figure
out
a
way
to
speed
up
reduced
risk
registrations
and
get
on
with
some
other
pressing
business.

On
the
resistance
management
exemptions,
we
think
that
this
proposal
makes
more
sense
than
the
renewable
exemptions.
The
agency
has
registered
a
few
dozen
very
promising
effective
reduced
risk
and
biopesticide
products
in
the
last
five
or
so
years,
yet
many
are
highly
vulnerable
to
resistance
problems
because
of
their
specific
mode
of
action.
It
is
a
good
idea,
indeed
essential
for
EPA
to
pull
out
the
stops
in
an
effort
to
head
off
resistance
problems
to
key
active
ingredients.
The
Section
18
program
can
play
an
important,
albeit
a
limited
role
in
achieving
this
goal.
Section
18'
s
in
the
name
of
resistance
management
should
only
be
approved
by
the
agency,
however,
when
there
is
solid
evidence
showing
that
both
registrants
and
growers
are
doing
everything
they
can
through
other
means
to
responsibly
manage
resistance.
Accordingly,
if
EPA
accepts
resistance
management
as
a
criterion
for
approval
of
Section
18'
s,
the
applicant
should
be
required
to
document
that
all
other
recommended
proven
resistance
management
strategies
are
being
used
to
the
full
extent
possible,
and
that
still
resistant
populations
are
growing
more
common
and/
or
levels
of
resistance
are
growing.
In
addition,
explicit
and
strict
resistance
management
language
should
be
incorporated
onto
the
labels
approved
covering
resistance
management
driven
Section
18'
s.
Plus,
the
label
should
specify
acceptable
rotations
of
active
ingredients
as
well
as
unacceptable
rotations.

Finally,
the
significant
economic
loss
proposal.
This
one
is
really
problematic
and
always
has
been,
I
guess,
and
I
think
it
always
will
be.
History
shows
over
and
over
that
farmers
seem
to
find
a
way
to
innovate
around
the
sky
is
falling
syndrome.
I
think
part
of
the
reason
that
they
do,
is
in
reality
there
are
far
more
pest
management
alternatives
than
advocates
of
Section
18'
s
might
want
to
admit
to.
Plus,
really
serious
major
losses
are
typically
associated
with
rather
unique
and
limited
combinations
of
soil
types,

In
talking
to
a
couple
of
my
colleagues
about
this
particular
proposal,
one
of
them
pointed
out
that
there
are
a
lot
of
people
who
are
knowledgeable
observers
of
what's
going
on,
including
Bob
Holm,
who
call
this
the
golden
era
of
pest
management.
And
I
think
that
that's
true.
We
think
that
too
many
Section
18'
s
in
the
past
have
been
justified
by
a
need
to
bail
out
farmers
who
have
made
mistakes
in
their
pest
management
systems,
and
we
would
strongly
oppose
granting
Section
18'
s
for
any
pesticides
other
than
reduced
risk
and
biopesticides
if
the
major
justification
is
the
breakdown
of
an
irresponsible,
full
throttle
pesticide
treadmill
based
pest
management
system.
That's
a
lot
to
get
out
there.
We
would
like
to
see
EPA
reward
a
commitment
to
IPM
and
penalize
sloppy
and
disruptive
levels
of
reliance
on
conventional
pesticides.
That
would
obviously
address
some
of
the
problems
that
we're
seeing,
not
only
with
economic
loss,
but
in
general.
And
we
appreciate
the
fact
that
we're
here
before
the
PPDC
discussing
this,
but
I
think
we
also
have
to
discuss
what
kind
of
­­
how
we
define
acceptable
alternatives
when
we're
judging
the
economic
impacts.
And
I
think
that's
a
general
comment
as
well
about
how
we
should
be
proceeding
on
Section
18'
s.
So
I
guess
my
overall
comment
is
that
we
feel
that
there
are
far
too
many
Section
18'
s
granted
in
general.
This
is
an
emergency
use
situation
and
it
should
really
be
treated
that
way.
MR.
CAULKINS:
Adam,
thank
you
very
much.
I
will
now
turn
it
over
to
Bill
Tracy
to
give
us
the
growers
perspective
on
those
reforms.
MR.
TRACY:
Thank
you,
Pete.
When
Pete
called
and
asked
me
to
be
on
this
panel,
he
said
you
have
five
minutes.
And
out
west,
a
farmer
can
hardly
say
howdy
in
five
minutes.
(
Laughter.)
MR.
TRACY:
So
I'm
going
to
have
some
prepared
comments
here,
because
my
mind
tends
to
wander
like
a
leppy
calf
in
a
herd
of
cattle
if
I
don't
keep
everything
focused.
Incidentally,
in
California
we
have
281
commercial
commodities
in
California
and
only
half
a
dozen
of
those
are
major
crops,
so
Section
18'
s
are
extremely
important.
A
good
farmer
is
known
to
have
down
field
vision.
We're
constantly
working
with
the
vagaries
of
nature
and
we're
planning
ahead
toward
a
multitude
of
variables,
and
that
helps
us
decrease
the
changes
of
getting
caught
with
a
surprise
and
an
unhappy
banker
at
the
end
of
the
season.

In
many
instances
when
our
fields
are
invaded
and
the
conditions
are
perfect
for
the
pest,
a
crop
can
be
lost
within
an
extremely
short
period
of
time.
Renewable
exemptions
would
allow
for
a
down
field
vision
of
a
planned
emergency
approach
for
a
Section
18
application
submitted.
All
the
paperwork
is
reviewed
much
in
advance
of
the
possible
need.
It
would
allow
for
an
orderly
review
without
the
rush
of
emergency
and
for
proper
planning
by
industry
if
a
problem
develops.
It
would
avoid
untimely
and
damaging
delays
of
going
through
the
application,
review
and
approval
process
for
an
emergency
before
an
emergency
has
been
established.
This
seems
best
for
all
sides
and
it
has
worked
well
in
California.
It
has
been
suggested
and
makes
a
lot
of
sense
to
issue
multi­
year
approvals
upon
completion
of
the
original
complete
review,
and
approval
of
second
and
third
years
would
be
left
up
to
the
respective
state's
review
for
renewal.
They
are
the
closest
to
the
previous
use
patterns
and
problems,
and
if
there
is
a
need
to
renew,
why
duplicate
the
same
process
and
same
review
each
year
at
the
state
and
federal
levels.

On
resistance
management
criteria,
establishing
significant
economic
loss
is
time
consuming
to
prove,
especially
in
an
emergency
situation.
Sometimes
five
year
data
is
impossible
to
obtain,
especially
on
new
minor
crops.
Resistance
management
criterion
points
the
issue
in
the
right
direction.
It
has
to
be
a
written
plan.
It
stresses
the
introduction
of
reduced
risk
products.
It
limits
the
use
of
old
products
by
seasonality
and
in
some
cases
the
number
of
applications
in
a
year.
It
stresses
introduction
of
new
chemistries
and
new
modes
of
action.

The
overall
goal
is
to
maintain
efficacy
of
whatever
product
is
used
with
the
hopes
of
not
developing
resistance
by
alternating
use
of
different
chemistries
and
modes
of
action.
This
would
put
more
tools
in
the
farmer's
resistance
management
toolbox.
Allowing
this
approach
for
qualifying
for
Section
18
would
encourage
the
implementation
of
resistance
management
programs
that
in
many
cases
are
just
being
looked
at
in
some
areas
today.
Our
California
program
has
been
effective
and
very
beneficial
to
our
industry
and
has
served
us
well
in
working
with
government
agencies.
On
a
sidebar
to
that,
I
think
allowance
of
reduced
risk
products
to
be
introduced
as
a
Section
18
certainly
has
merit,
since
they
receive
favorable
treatment
in
today's
review
and
release
processes.

Establishing
a
new
calculation
for
significant
economic
loss.
Money
should
not
always
be
the
determining
factor
in
economic
analysis
because
of
marketing
schemes
and/
or
market
and
price
fluctuations.
Also,
yield
losses
must
be
weighed
with
an
analysis,
and
is
probably
just
as
an
important
factor
as
the
bottom
line
dollars.
But
don't
forget.
You
can
have
a
good
price
and
a
good
yield,
but
if
quality
suffers
­­
as
in
my
industry's
case,
sticky
cotton
­­
or
production
costs
soar
­­
such
as
pest
control
­­
you
will
lose
on
the
bottom
line.
And
five
years
of
data
sometimes
is
impossible
to
provide.
In
conclusion,
with
a
loss
of
use
associated
with
FQPA,
Section
18'
s
become
increasingly
important.
The
Section
18
process
has
served
the
industry
well
by
allowing
the
introduction
of
new
chemistries
and
modes
of
action
to
address
emergency
situations
prior
to
certain
products
receiving
final
registration.
This
process
does
not
dilute
the
necessity
and
important
review
process,
but
gives
opportunity
for
further
review
in
real
life
but
controlled
settings.
Unknown
and
unaddressed
problems
are
sometimes
realized
in
the
process
and
are
able
to
be
corrected
and/
or
addressed
before
final
labels
are
issued
and
widespread
use
is
initiated.

Now,
just
as
a
little
aside
and
as
a
member
of
the
regulated
community,
I'm
going
to
ask
the
committee's
indulgence
to
share
with
our
regulators
a
little
insight
from
the
field.
Farmers
by
nature
have
an
aversion
to
paperwork.
We
view
it
as
taking
time
away
from
our
fields,
and
that
is
where
a
whole
lot
of
conflict
and
misunderstanding
comes
from
the
regulated
community
and
the
regulators.
Filling
out
paperwork
either
takes
time
away
from
our
fields
or
something
that
must
be
done
after
dark
and
after
work.
Simply
stated,
we
have
a
dirt
oriented
community
regulated
by
paper
oriented
agencies.
In
my
view,
mandatory
regulation
would
be
much
more
palpable
without
mandatory
paperwork.
I'm
going
to
share
with
you
a
form
letter
our
family
farm
sends
out.
We
receive
about
eight
to
10
solicitations
for
surveys
a
week
in
the
mail.
This
is
one
paragraph
that
comes
from
there.

It
says
we
are
drown
in
required
county,
state
and
federal
forms,
surveys,
reports,
records,
notifications,
postings,
filings,
permits,
certificates,
fees,
descriptions,
licenses,
registrations,
inventories,
audits,
meetings,
classes,
returns,
validations,
amendments,
inspections,
responses,
handbooks,
pamphlets,
warnings,
appeals
and
a
slew
of
others
that
don't
come
to
mind
right
now.
It
is
getting
difficult
to
find
time
to
break
away
from
the
office
to
do
real
work.
Thank
you
very
much.
MR.
CAULKINS:
Thanks,
Bill.
By
my
watch,
we
have
about
25
minutes
for
questions
or
comments.
DR.
LOCKWOOD:
I'm
concerned
by
what
I
think
I'm
hearing
as
an
excessive
focus
on
the
bottom
line
being
dollars.
I
was
at
a
speech
last
week
where
one
of
the
speakers
said
money
is
only
money.
As
a
physician,
I
think
that
health
based
criteria
ought
to
be
essential
in
the
determination
of
whether
a
Section
18
exemption
ought
to
be
granted.
And
I
heard
only
the
most
oblique
reference
to
anything
that
had
to
do
with
health
in
this
process.
MALE
SPEAKER:
I
thought
it
was
an
excellent
panel
presentation.
Thank
you.
It
was
really
very
illuminating,
and
I
liked
a
lot
of
the
ideas.
One
of
the
points
that
Adam
made,
that
I
thought
was
very
good,
of
course,
was
looking
at
reduced
risk
and
biopesticides.
Naturally,
I
think
that's
a
great
idea.
The
other
thing
from
my
perspective,
Robin,
and
your
counterparts
in
the
other
states,
one
of
the
problems
we
are
finding
in
the
biopesticide
industry
is
that
we're
not
being
looked
at
as
the
alternatives
that
are
already
registered
products.
And
that
has
been
typical.
We
see
these
coming
through
occasionally,
and
we're
starting
to
see
them
after
the
fact.
And
we
try
to
maybe
do
something
for
next
year,
too,
but
we
find
that
the
states
don't
always
look
at
viable
alternatives
that
are
already
registered.
And
I
think
it's
incumbent
on
the
states
and
the
U.
S.
EPA
to
look
at
products
that
are
already
registered,
and
particularly
the
biopesticides.
MS.
POPOWITZ:
Sorry.
It
usually
takes
so
much
longer
to
get
to
me.
I
want
to
comment
on
­­
sort
of
pull
together
a
few
of
what
I
thought
were
really
pertinent
comments
that
went
around
the
table
and
make
a
point
from
my
perspective,
which
is
the
public
health
perspective.

We're
very
much
supportive
of
the
Section
18'
s.
I
understand
emergencies.
I
understand
farmers.
I
understand
bugs
and
funguses.
And
clearly
that's
not
an
argument,
I
think,
around
this
table
that
the
importance
of
having
those
are
required.
Furthermore,
as
Robin
pointed
out,
it
is
part
of
the
appropriate
integrated
pest
management
system
to
respond
to
emergencies.
Taking
that
point,
though,
and
really
integrating
it
into
the
conversation,
it
also
goes
against
what
­­
I
can't
even
quote
Adam's
sentence.
But
it
had
like
a
lot
of
chemicals
used
on
the
field
chronically.
And
chronic
low
level
constant
chemical
assault
of
the
soil
is
not
a
long
term
solution,
but
it
is
the
way
farming
is
done
for
the
most
part.

We
are
having
a
huge
problem
right
now
that
everybody
is
completely
aware
of,
which
is
antibiotic
use
on
farms,
and
this
is
chronic
low
level,
constant
in
the
feed
and
in
the
animal
antibiotic
usage.
The
antibiotics
that
have
been
preserved
in
the
medical
environment
as
our
hard
hitting,
silver
bullet,
never
used
unless
the
guy
is
half
dead
type
things,
are
being
used
in
agriculture
chronically
and
constantly.
And
they're
surveying
workers
that
work
with
these
animals,
and
they're
finding
that
they
have
some
of
these
low
level
resistance
organisms
to
what
we
consider
the
silver
bullet
biomedical
solutions
with
antibiotics.
Chemicals
are
no
different.
And
so
when
you're
using
chemicals
at
chronic
low
levels
constantly,
that's
not
­­
you're
­­
that's
not
in
tune
with
what
you're
referring
to
as
an
integrated
pest
management
need
for
a
Section
18.
So
we're
not
asking
for
both.
It's
not
fair
to
say
we
need
Section
18'
s
because
this
is
part
of
integrated
pest
management,
but
we
also
need
to
constantly
assault
the
soil
with
chemicals.
It
is
not
going
to
work
in
the
long
term.
That's
why
we
have
so
much
pest
resistance,
and
that's
why
we
have
soil
plums,
and
that's
why
we
have
soil
blowing
around
and
burnt
out
soil
and
all
sorts
of
other
problems
and
health
problems.
So
really
understanding
the
importance
of
Section
18
needs
to
be
disjointed
from
this
repeat
registration
year
after
year
after
year
which
no
longer
constitutes
an
emergency,
but
actually
constitutes
a
way
of
life
and
we
need
to
deal
with
that
separately.

Also,
I
want
to
stress
the
importance
of
considering
as
alternatives,
as
Robin
and
some
other
people
did,
but
to,
again,
integrate
that
into
practice
to
consider
­­

(
End
of
Tape
4,
Side
A.)
MS.
POPOWITZ:
­­
so
that
emergencies
can
be
responded
to
and
that
people
can
sleep
well
at
night.
Not
just
the
farmers,
but
all
the
rest
of
us
that
live
around
them
and
eat
the
food.
Thank
you.
MR.
CAULKINS:
Likewise.
Dan?
MR.
BOTTS:
One
quick
question,
first.
On
your
survey
or
your
case
study
of
the
threshold
studies,
will
more
than
just
a
summary
of
that
document
be
available?
Because
I
would
like
to
look
at
it
just
from
the
context
of
the
Section
18'
s
that
we're
involved
in
on
the
cost
analysis
that
is
there
relative
to
crop
site
pest
combinations
don't
always
fit
into,
as
Robin
pointed
out
in
the
watermelon
example,
the
model.
The
economic
models
that
you're
talking
about.
I
would
like
to
see
the
universe
of
actual
Section
18
petitions
that
went
into
that
survey,
if
I
could,
just
to
look
­­
get
a
crop
site
combination.
MALE
SPEAKER:
You
would
like
to
get
a
list
of
all
the
crop
site
combinations?
MR.
BOTTS:
Yeah,
that
went
into
the
survey
and
if
any
of
them
were
petitions
that
we
had
submitted.
And
I
would
like
to
ask
a
question
of
the
people
sitting
around
this
table
right
now.
I
know
Robin
deals
with
Section
18'
s.
How
many
other
people
in
this
room
have
actually
written
and
submitted
Section
18
petitions
to
the
agency
for
approval?
A
point
I
would
like
to
make.
We
do
about
the
same
number
that
Robin
does
through
our
association.
We
are
the
petitioning
organization
for
the
specialty
crop
industry
to
the
state
lead
agency
in
Florida.
The
issue
that
Jennifer
brought
up
on
discussion
of
alternatives,
we've
not
submitted
a
petition
since
1982
or
'
83
that
didn't
address
every
registered
alternative
or
potential
production
practice
associated
with
control
of
that
pest.
We
produce
our
petition.
It
goes
through
a
state
review
process.
It
usually
takes
a
tremendous
amount
of
time
before
it
ever
gets
to
the
federal
level
where
all
of
those
issues
are
scrutinized
and
looked
at.

I'm
fully
supportive
of
the
reforms
that
are
proposed
in
this
thing,
but
I
think
there
is
a
misconception
about
what
is
currently
in
Section
18
petitions
and
an
understanding
of
what
you
have
to
look
at
from
a
public
health
standpoint.
Those
factors
are
reviewed
not
only
by
EPA,
but
at
least
in
the
case
of
Florida,
and
I
know
in
the
case
of
California,
at
the
state
level
extremely
extensively
before
those
petitions
ever
go
forward.
I
think
that's
one
of
the
reasons
why
the
denial
rate
is
a
little
bit
lower.
And
the
ones
that
we've
had
kicked
back
for
one
reason
or
another
have
not
been
because
of
the
review
process
that
was
done
prior
to
getting
to
the
agency.
It
was
things
that
came
to
life
after
the
petition
had
been
submitted
that
led
to
issues
around
a
particular
crop
pest
combination.
So
I
would
suggest
that
the
direction
you're
headed
is
a
great
first
step.
I
would
also
go
back
to
the
'
96
workshop
and
pull
out
a
lot
of
the
other
recommendations
that
came
out
of
that
stakeholder
group
involvement,
that
included
more
than
AAPCO
and
the
state
lead
agencies
and
putting
forward
a
proposal,
including
public
interest
groups
and
other
people,
and
look
at
some
of
those
other
options
to
pilot
as
well.
MR.
CAULKINS:
Thank
you.
MS.
SPAGNOLI:
I'm
speaking
from
the
manufacturer's
perspective.
On
one
thing,
I
guess,
I
will
agree
with
Adam.
We,
of
course,
support,
you
know,
faster
review
and
registration.
However,
in
the
situation
with
emergencies,
oftentimes
the
data
necessary
to
support
the
registration
needs
to
be
generated
in
response
to
that
emergency.
The
glassy
wing
sharpshooter
being
one
of
the
examples
where
a
new
pest,
you
know,
erupted.
There
was
an
emergency
situation
and
data
needed
to
be
generated
to
support
a
Section
3
registration.
So
you
know
you're
going
to
have
that
emergency
situation
continue,
so
while
that
data
can
be
generated
and
reviewed,
that
emergency
will
continue
to
exist.

Also
from
a
manufacturer's
perspective,
we
only
produce
a
chemical
that
we're
going
to
sell.
You
generally
plan
to
only
­­
you
know,
nobody
keeps
excess
inventories
of
chemicals.
We
only
are
going
to
buy
raw
materials
and
produce
as
much
chemical
as
we
plan
to,
you
know,
use
that
next
season.
So
from
that
perspective,
to
have
a
more
predictable
process
for
being
able
to
supply
the
growers
would
obviously
be
an
advantage
to
manufacturers
in
their
production
planning.
If
there
was
a
renewal
process
that
they
could
then
know
that
­­
predict
what
quantities
were
going
to
be
needed
for
a
particular
crop
or
pest
for
that
next
year,
it
would
definitely
make
sure
that
we
could
provide
the
growers
with
the
amount
of
chemical
they
were
going
to
need.
MR.
CAULKINS:
Lori?
MS.
HARDER:
From
a
tribal
perspective,
we
deal
with
Section
18
issue
on
the
Tribal
Pesticide
Program
Council,
and
some
tribes
are
­­
would
like
to
use
Section
18
because
they
do
have
production
agriculture
and
other
tribes
do
not.
But
there
is
a
consensus
amongst
TPPC
members
that
would
support
some
kind
of
Section
18
reform
that
would
be
more
restrictive,
and
a
reform
that
would
be
for
an
emergency
exemption
and
not
for
an
emerging
trend.

And
as
somebody
who
does
monitoring,
a
lot
of
our
tribal
lands
are
at
or
adjacent
to
agricultural
lands
or
wherever
pesticides
are
being
used,
and
I
monitor
water
quality
and
soil
and
air
quality
and
those
type
of
media.
And
it
gets
really
hard,
because
for
a
lot
of
new
chemicals
that
are
being
used
that
are
registered
­­
they've
gone
through
the
registration
process
­­
there
aren't
laboratories
that
can
analyze
the
media
to
see
if
it
is
in
the
environment.
And
so
for
Section
18'
s
that
aren't
registered,
I'm
going
to
assume
that
there
won't
be
any
analytical
methods
for
those
in
laboratories.
So
how
does
this
really
ensure
environmental
quality?
You
know,
that
there
is
no
harm
to
the
environment
or
that
there
is
no
persistence,
and
how
can
I
take
that
back
to
the
people
and
let
them
know
that?
MR.
CAULKINS:
Larry?
MR.
ELWORTH:
Are
you
all
going
to
answer
that
question?
Okay.
MR.
CAULKINS:
It's
answered.
MR.
ELWORTH:
Well,
actually
one
of
the
things
I
did
want
to
mention
that
didn't
come
up
when
Alan
raised
his
concern
that
the
agency
does
a
review
of
the
environmental
and
health
impacts
of
these
Section
18'
s
before
you
grant
them.
It's
not
just
­­
there
are
criteria
that
you
follow
besides
economic
in
determining
whether
you're
going
to
grant
an
18
or
not.

Secondly,
I
do
think
one
of
the
things
Robin
said
made
a
great
deal
of
sense.
It
doesn't
make
a
whole
lot
of
­­
it
makes
a
lot
of
sense
to
not
wait
until
nothing
works
to
decide
to
take
some
action.
I
think
that's
a
smart
way,
both
from
an
integrated
pest
management
and
from
a
regulatory
point
of
view,
to
look
at
this
alternative
­­
using
the
alternatives
for
resistance
management.
I
wasn't
quite
clear,
and
maybe
this
isn't
the
right
time
to
mention
it.
How
are
you
going
to
explain
the
data
requirements
for
the
economic
loss
provisions?
Would
someone
know
beforehand
which
of
the
tiers
they
were
applying
for
and
would
there
be
criteria
guiding
people
for
using
tier
or
another?
And
you
can
decide
if
this
isn't
the
place
to
describe
that,
but
I
would
be
interested
in
knowing
that.
It
might
be
helpful.
MALE
SPEAKER:
We
will
make
the
criteria
available
and
transparent,
and
if
you
want
to
talk
about
the
details,
during
the
break
I'll
be
happy
to.
MR.
ELWORTH:
Sure.
Sure.
Also,
this
FR
notice?
What
is
the
nature
of
this
FR
notice?
Is
this
­­
does
the
agency
believe
that
this
­­
this
requires
rulemaking?
Are
you
making
a
proposed
change
to
guidelines?
What
is
the
deal.
FEMALE
SPEAKER:
As
we're
currently
envisioning
them
right
now,
it
would
really
just
be
a
Federal
Register
notice
describing
the
­­
actually
a
lot
of
what
you
heard
the
EPA
panel
talk
about
this
morning.
Probably
filtering
in,
I
think,
a
lot
of
the
different
comments
that
you're
making.
But
it
wouldn't
actually
be
a
rulemaking.
MS.
MULKEY:
We
believe
it
can
be
done
under
the
existing
regulation.
MS.
BRICKEY:
Well,
I
have
some
comments,
but
I
first
wanted
to
ask
a
couple
of
questions.
What
is
the
agency's
policy
now
about
allowing
a
Section
18
for
a
pesticide
that
is
not
registered?
No
Section
3.
MS.
MULKEY:
You
mean
no
Section
3
for
the
active
ingredient?
MS.
BRICKEY:
Right.
MS.
MULKEY:
Or
no
Section
3
for
that
use?
MS.
BRICKEY:
No
Section
3.
MS.
MULKEY:
Rob?
MR.
FORREST:
Are
you
talking
about
a
new
chemical?
MS.
BRICKEY:
Uh­
huh.
I
hope
so.
MR.
FORREST:
Okay.
As
far
as
a
new
chemical
is
concerned,
we
have
had
Section
18'
s
on
new
chemicals.
But
we
have
only
had
Section
18'
s
on
new
chemicals
when
we've
had
enough
data
to
make
the
assessment
that
we
need
to
make.
MS.
BRICKEY:
Meaning
you've
been
able
to
grant
a
tolerance?
MR.
FORREST:
We
have
granted
temporary
limited
tolerances,
yes.
MS.
BRICKEY:
And
how
many
of
those
have
there
been,
approximately?
MR.
FORREST:
Very
few.
Certainly,
maybe
a
handful,
if
that.
If
that.
MS.
BRICKEY:
And
what
about
if
you
canceled
a
use
on
a
particular
crop.
Have
you
granted
subsequent
Section
18'
s
for
that
use?
MR.
FORREST:
For
a
different
chemical?
MS.
BRICKEY:
No.
MR.
FORREST:
No.
MS.
BRICKEY:
For
the
same
chemical.
Let's
say
you
have
a
pesticide.
You
cancel
certain
uses
for
a
variety
of
reasons.
MR.
FORREST:
Right.
MS.
BRICKEY:
But
not
all
uses.
MR.
FORREST:
Right.
Probably
­­
I
don't
know
off
the
top
of
my
head,
but
certainly
we
would
be
suspect
to
go
forward
with
an
18
where
we
canceled
uses.
MS.
BRICKEY:
Do
you
have
a
policy
on
that?
MS.
ROSENBAUM:
Carolyn,
the
current
regs
that
provide
the
framework
for
the
Section
18
program
actually
create
what
I
would
call
sort
of
a
higher
hurdle.
If
you're
talking
about
a
pesticide
for
which
we've
had
significant
risk
concerns,
there
is
a
public
notification
piece
that
we
go
through
so
that
we
actually
have
to
issue
a
FR
notice
telling
the
world
that
we
have
received
the
request.

And
if
it
were
literally
for
a
use
that
­­
if
it
was
the
same
use
that
had
been
canceled
for
risk
concerns,
the
actual
process
is
in
fact
quite
a
bit
more
elaborate.
And
at
least
in
my
memory,
I
don't
remember
receiving
a
request
in
such
a
circumstance
or
much
less
actually
granting
it.
So
there
is
a
pretty
high
hurdle
when
you're
talking
about
a
chemical
where
we
have
identified
significant
risk
concerns.
MS.
BRICKEY:
MS.
ROSENBAUM:
Well,
the
basic
policy
is
laid
out
in
the
existing
Section
18
regulations,
and
it's
not
a
flat
out
we
will
never
consider
it
again.
But
it
creates
a
process
that
is
designed
to
provide
opportunity
for
significant
external
participation
and
oversight
precisely
because
there
was
some
underlying
reason
for
concern
about
that
use.
MS.
MULKEY:
We
couldn't
grant
it
unless
it
met
the
statutory
standard.
Whatever
the
relevant
standard
was.
MS.
BRICKEY:
My
experience
in
working
with
this
program
is
that
the
feeling
about
how
it
is
operated
has
waxed
and
waned
at
least
three
different
times
I
can
think
of.
The
tightening
of
the
program
has
been
a
result
of
huge
numbers
of
Section
18'
s,
oversight
from
the
Hill,
and
whatever
pressures
the
agency
has
felt
to
reform
the
program
and
make
it
better.

In
this
case,
which
would
be
a
major
loosening
of
the
program,
I
don't
know
exactly
what
the
pressure
is,
except
that
people
feel
that
it
is
hard
to
provide
data,
which
I'm
sure
sometime
it
is,
and
they
don't
like
to
do
paperwork,
which
I
totally
understand
because
I
don't
like
to
do
paperwork,
either,
and
I
can
hardly
figure
most
of
the
paperwork
I
do
out.
However,
the
number
of
days
it
takes
to
get
a
Section
18
are
dramatically
down.
The
number
of
crises
exemptions
are
way
down.
And
the
number
of
denials
are
way
down.
So
it's
sort
of
hard
for
me
to
understand
why
we
need
to
undertake
a
major
reform
of
this
program,
given
the
fact
that
it
seems
to
be
working
very
well.
And
the
other
concern
I
have
is
that
this
is
already
a
pretty
fluid
program,
shall
we
say,
and
we're
adding
more
and
more
­­
we're
taking
some
of
the
rigor
we
have
in
it
­­
assuming
we
have
rigor
­­
and
we're
eliminating
it
and
making
it
easier
to
get
Section
18'
s.
So
another
concern,
I
guess,
that
brings
to
bear
for
me
is
what
would
be
the
cost
of
making
these
changes?
Would
the
program
be
cheaper
if
you
did
it
this
way
because
you
have
­­
you're
certifying
repeat
applications?
You
know,
where
is
the
good
government
angle
on
this.

MR
FORREST:
I
don't
think
that
the
cost
would
be
so
much
EPA's
cost.
I
think
it
would
be
more
for
the
states.
MS.
BRICKEY:
So
the
program
would
cost
EPA
the
same,
approximately?
MR.
FORREST:
Well,
certainly
there
would
be
resources
in
terms
of
processing
the
Section
18'
s.
That
would
save
some
resources
for
the
Registration
Division.
MS.
BRICKEY:
Have
you
projected
those
costs?
MR.
FORREST:
Not
exactly,
no.
MS.
BRICKEY:
I
was
just
wondering
if
maybe
we
would
save
some
money
that
we
could
apply
to
new
registrations
since
we
have
a
backlog
there.
MS.
MULKEY:
It's
relatively
modest.
MR.
FORREST:
I
don't
think
that
the
money
­­
the
cost
that
we
would
be
saving
in
terms
of
the
processing
of
the
Section
18'
s
would
necessarily
transfer
into
review
of
new
chemicals.
MS.
BRICKEY:
So
I
guess
my
feeling
about
this
is
if
we
had
a
fairly
rigorous
program,
I
would
certainly
support
the
notion
of
doing
­­
certifying
renewals.
I
don't
have
a
big
problem
with
that,
because
I
think
mostly
that
is
a
matter
of
paperwork.
But
because
we
have
what
is
a
pretty
lax
program
now
and
we're
proposing
to
make
it
much
more
lax,
I'm
just
wondering
about
the
value
of
this
program.
You
know,
I
guess
I
raised
this
when
you
had
your
workshop
in
1996,
Jim.
I'm
just
wondering
if
we
shouldn't
just
give
the
states
these
18
exemptions
when
they
ask
for
them
and
then
evaluate
what
happened
afterward,
because
I'm
not
sure
that
we're
going
to
be
doing
a
whole
lot
here
to
protect
the
public
health,
given
the
fact
that
the
standards
are
going
to
be
much
lax
­­
more
lax
than
they
are
now.
MR.
CAULKINS:
Bob?
MR.
HOLM:
Thank
you,
Pete.
First
of
all,
I
want
to
compliment
the
panel
for
an
excellent
presentation.
I've
been
in
industry
and
around
for
30
years,
and
I
think
that
was
the
best
clearest
explanation
that
I've
heard.
And
also,
I
guess,
with
the
being
around
for
a
long
time,
it
gives
you
a
little
bit
of
context.

I
would
like
to
remind
people
that
back
in
the
'
80'
s
there
was
a
lot
of
complaints
about
Section
18'
s
because
they
just
seemed
to
be
perpetual.
There
were
Section
18'
s
for
eight
or
10
years
or
so.
I
think
maybe
the
longest
one
had
run
up
to
12
or
15
years,
and
people
were
saying
well,
this
is
just
a
way
for
market
entry
early
and
to
avoid
the
process
of
getting
the
data.
I
will
say
that
I
think
this
is
dramatically
changed
right
now.
It's
been
noted
in
kind
of
a
reference
in
Rob's
presentation,
but
IR­
4
this
last
year
was
involved
in
about
160
of
those
400
some
Section
18'
s.
So
we
have
a
significant
part
of
the
program.
We
don't
initiate
the
request.
Obviously
they
come
at
the
request
of
the
state.
But
when
we've
got
ongoing
programs
on
those
minor
crops
that
we
can
provide
residue
data,
you
know,
we've
got
a
committed
program.
We're
going
to
finish
the
work.

We
have
a
30
month
completion
schedule
that
we've
committed
to
the
grower
community
and
EPA
that
we're
going
to
get
the
work
done
and
complete
it.
There
is
a
commitment
there.
So
there
are
data
there.
When
the
state
requests
them,
we
immediately
submit
the
residue
data
that
we
have
available
so
that
EPA
can
make
the
risk
assessments
and
the
dietary
risk
assessments
in
order
to
judge
whether
that
product
is
safe
or
not.
I
think
what's
missing
here
in
some
of
the
discussions
­­
and
Bill,
as
a
grower,
pointed
it
out.
Most
of
these
uses
are
for
minor
crops.
And
FQPA
is
very
hard
­­
boring
down
on
taking
products
away
­­
older
products
­­
for
minor
crop
growers.
So
what
does
that
leave
growers
to
use?
IR­
4
has
focused
exclusively
our
program
on
reduced
risk,
safer
chemistries
and
biopesticides
to
provide
FQPA
transition.
So
this
is
what
we're
working
for.
And
to
not
allow
these
chemistries
into
the
market,
I
think,
is
not
participating
in
the
FQPA
transition
process.
I
think
another
thing
to
really
consider
here
is
the
fact
that
a
lot
of
these
newer
chemistries
have
very
specific
modes
of
action,
and
the
registrants
are
restricting
their
use
to
not
more
than
one,
or
two
sometimes,
applications
a
year,
which
sets
up
resistant
­­
you
know,
it
calls
for
resistance
management
strategies.
And
many
of
these
minor
crops
only
have
one
or
two
crop
protection
tools
for
any
particular
insect
or
disease.

So
if
you
restrict
it
to
one
product
and
don't
allow
multiple
products
to
have
different
modes
of
action
in
order
to
use
resistance
management,
you
are
jeopardizing
that
new
chemistry
within
two
to
three
years
of
developing
resistance
before
the
product,
you
know,
can
really
be
used.
So
I
think
the
Section
18
process
is
working.
IR­
4
is
committed
to
supporting
it,
and
we're
committed
to
getting
new
reduced
risk
chemistries
on
the
market
that
are
safer
for
the
environment
and
for
human
health
use.
MR.
CAULKINS:
Thank
you.
Our
hour
and
15
minutes
is
up.
I'm
going
to
ask
Shelley
and
Lori
and
Jay
who
had
their
cards
up
and
that's
it.
MS.
MULKEY:
And
John.
MR.
CAULKINS:
And
John.
MS.
DAVIS:
Thank
you.
I'm
here
on
this
committee
today
representing
Eric
Nicholson,
and
Eric
in
particular
wanted
to
comment
on
this
issue.
And
so
I
am
presenting
his
comments.
Eric
Nicholson
works
for
the
Farmworker
Union
Pecoon
in
Oregon,
and
so
his
experience
really
focuses
on
Oregon.

From
1993
to
1999
the
State
of
Oregon
received
178
Section
18'
s,
at
least
10
of
which
involved
approvals
of
the
same
chemical
for
three
or
more
consecutive
years.
So
we're
really
concerned
about
too
much
approvals
of
things
that
are
not
emergencies
where
the
Section
18
begins
to
look
like
a
round
end
of
the
Section
3
process.
In
particular,
we
would
like
to
raise
the
example
of
Encloselin,
which
in
the
late
'
90'
s
received
its
15th
consecutive
Section
18.
So
this
is
not
the
past
history.
This
is
a
very
current
thing.
And
Encloselin
in
particular
raises
a
lot
of
concerns
for
workers,
because
the
evidence
suggests
that
it
has
an
anti­
androgen
effect,
and
so
it
does
pose
a
significant
health
concern.
And
so
in
our
view,
it
raised
the
problem
that
this
was
approved
year
after
year
and
there
was
no
adequate
protections
given
on
the
worker
side.
And
in
that
perspective,
aside
from
our
general
opposition
to
this
renewal
process,
we
would
like
to
see
that
when
a
product
is
given
a
Section
18
and
there
are
risk
concerns,
that
there
be
added
enforcement
requirements
to
ensure
that
worker
safety
really
is
being
protected.

Another
thing
we
are
really
concerned
about
is
the
loosening
of
the
criteria
on
economic
loss.
Because,
again,
that
just
seems
to
feed
the
idea
that
these
things
should
be
renewed
year
after
year.
So
in
a
nutshell
­­
let
me
just
raise
one
other
thing.
I
am
­­
I'm
not
an
eyewitness
to
this,
so
I
just
want
to
raise
this
in
response
to
what
Carolyn
raised.
And
that
is
that
it's
my
understanding
that
Vincloselen
has
now
been
subject
to
an
agreement
with
the
registrant
to
phase
out
uses
for
snap
beans
in
a
couple
of
years
from
now,
and
that
when
this
agreement
was
reached,
the
issue
got
raised,
well,
what
happens
if
we
still
need
this
as
a
Section
18
after
the
phase
out.
And
this
is
a
phase
out,
not
a
cancellation.
But
the
problem
that
precipitated
the
phase
out
is
a
health
problem.
And
it's
my
understanding
that
the
EPA
basically
said
that
they
would
entertain
a
Section
18
at
that
time.
So
it
is
our
view
that
the
Section
18'
s
become
an
around
an
un­
registration
even
when
there
are
health
risks.
MR.
CAULKINS:
John?

JOHN:
Thank
you.
I
decided
to
raise
mine
back
up
after
what
I
heard
Bob
say.
I
just
wanted
to
touch
on
one
little
item
quickly
with
respect
to
resistance
management.
The
current
approach
has
to
do
with
problems
that
already
exist,
and
the
way
it's
proposed
to
be
reformed
or
the
rewrite
is
what
is
developing
or
happening.
And
I
would
just
say
that
perhaps
what
you
should
do
is
write
it
so
that
it's
a
little
more
forward
looking,
because
you
know
the
factors
that
are
likely
to
lead
to
resistance
to
develop.
So
that
means
that
you
could
predict
if
it
would
happen.
So,
therefore,
why
not
look
forward,
because
the
costs
of
allowing
it
to
happen
are
too
great.
And,
of
course,
the
steps
towards
resistance
management
developing
occur
before
you
recognize
them
­­
or
before
you
can
recognize
them.
Does
that
make
sense?
So
take
a
little
bit
more
forward
approach
and
maybe
rewrite
that
a
little
bit
differently,
so
it's
looking
to
the
future
and
looking
at
our
predicted
capabilities
with
respect
to
resistance
management.
Does
that
make
sense?
MS.
BERGER:
Okay.
I
had
a
comment
and
a
couple
of
questions.
First
of
all,
it
was
brought
up
by
Adam
that
one
of
the
reasons
Section
18'
s
are
needed
is
because
farmers
need
to
be
bailed
out
because
they've
made
bad
pest
management
decisions.
And
I
really
take
exception
with
that,
Adam,
because
I
think
that
farmers
are
some
of
the
best
multi
taskers
that
I've
ever
seen.
And
we
really
do
appreciate
diversity
in
germ
plasma.
We've
made
mistakes
in
the
past
with
disease
susceptibility
and
that
kind
of
thing.
Diversity
in
germ
plasma
and
diversity
in
products
­­
I
can
tell
you
in
working
at
the
field
level
that
when
a
Section
18
goes
through,
it
is
not
­­
growers
don't
really
like
to
have
to
rely
on
that
system.
It
is
a
pain
for
a
commodity
group
to
have
to
go
through
the
paperwork
and
generate
that.
And
then
when
a
Section
18
is
granted
­­
and
I
know
in
California,
DPR
­­
they
generally
do
not
submit
a
Section
18
package
to
U.
S.
EPA
unless
they
are
very
sure
it's
going
to
go
through.
So
the
number
­­
because
we
have
so
few
refusals
at
the
national
level,
that
means
that
anything
that
might
have
been
rejected
was
most
likely
done
so
at
the
state
level.

And
when
a
Section
18
is
passed,
there
is
automatically
a
reduced
­­
I
mean,
excuse
me
­­
a
restricted
use
pesticide.
So
that
means
that
there
are
­­
there
is
extra
reporting.
They
are
subject
to
monitoring
at
the
time
of
application
by
the
local
ag
commissioners
and
so
forth,
and
there
are
in
fact
enforcement
requirements,
whether
it's
health
or
whether
it's
environment.
There
might
be
X
number
of
feet
from
waterways.
There
might
be
special
protective
equipment
and
this
type
of
thing.
So
I
just
would
­­
for
people
that
are
not
familiar
at
the
field
level
with
how
a
Section
18
comes
about,
believe
me.
Growers
would
much
rather
have
a
product
that
does
not
have
these
restrictions
on
it
and
has
a
full
label.
So
that
is
really
what
growers
want.
So
I
just
wanted
to
make
that
comment.
And
I
just
had
a
couple
of
questions.
One,
on
these
three
tiers,
is
the
data
all
submitted
at
once
in
these
three
tiers,
or
do
you
submit
a
tier
and
then
come
back
with
another
tier?
Is
it
one
time
or
two
times
or
three
times?
MR.
WIDAWSKY:
The
idea
is
that
you
would
submit
the
data
once,
and
whatever
is
sufficient
to
make
the
case
is
what
you
would
submit
if
there's
yield
data.
If
you
want
to
make
a
case
and
yield
data
is
not
sufficient
to
make
a
case,
you
think
about
the
second
tier.
And
if
you
make
the
determination
before
you
send
it
to
us,
as
you
say
you're
screening
it
before
then,
then
you
may
look
at
the
data
and
analyze
and
consider
them,
and
you
may
want
to
submit
more
data
that
would
cover
a
tier
three
analysis.
So
it
would
be
one
submission.
MS.
BERGER:
Okay.
MR.
WIDAWSKY:
And
then
whatever
data
would
be
appropriate
to
make
a
determination
is
what
we
look
at.
MS.
BERGER:
Okay.
And
then
finally
one
last
question.
One
of
the
­­
on
the
slide
that
talked
about
when
would
renewable
exemptions
be
unlikely,
one
of
the
bullet
points
was
that
an
alternative
product
was
unavailable
due
to
supply
shortages.
And
I
can
see
how
that's
maybe
bad
planning
on
the
side
of
the
registrant
or
the
manufacturer.
But
I
can
see
certain
cases
where
this
would
be
an
emergency
for
a
grower.
Why
is
the
grower
being
the
one
kind
of
punished
here
for
bad
projections
on
the
part
of
a
registrant?
MR.
FORREST:
What
I
was
saying
was
that
if
there
is
an
alternative
that
has
been
registered
but
that
alternative
might
not
be
available,
then
we
can
use
a
Section
18
for
another
chemical.
MS.
BERGER:
But
if
it's
not
available
due
to
a
supply
shortage,
I
mean,
it's
not
available.
I
mean,
so
­­
MS.
MULKEY:
He
was
saying
you
would
use
the
Section
18
in
that
year.
MR.
FORREST:
Right.
Right.
MS.
MULKEY:
But
it
wouldn't
be
a
good
candidate
for
a
multi
year.
MS.
BERGER:
Oh,
okay.
Okay.
MS.
MULKEY:
That
was
what
that
slide
was
about.
MS.
BERGER:
Okay.
MR.
CAULKINS:
Last
comment.
MR.
VROOM:
It
feels
to
me
like
there
has
been
a
lot
of
progress
made,
and
like
many
who
have
already
spoken,
you
know,
I
feel
like
a
veteran
who
has
had
moments
when
my
head
was
spinning,
maybe
even
literally
as
well
as
figuratively,
when
we
talked
about
Section
18'
s
in
the
past.
But
I
would,
you
know,
vote
on
the
side
of
those
comments
that
have
already
been
made
that
express
appreciation
for
the
progress
that
the
agency
is
making.
I
may
have
missed
it,
but
I
didn't
hear
any
references
to
USDA's
involvement
in
this
process.
I
assume
that
that's
happening
and
I
would
encourage
that.
And
I
think
in
the
next
section
of
our
discussions
here
on
resources,
it's
appropriate
for
us
to
talk
a
little
bit
more
about,
you
know,
what
does
Section
18
cost
in
terms
of
agency
resources
and
what
can
be
saved.
And
Carolyn's
point
in
that
area,
I
think,
is
an
excellent
one
that
we
ought
to
continue
to
put
some
focus
on.
The
last
question
is,
I
recall
­­
I
don't
have
a
copy
of
FQPA
here
with
me.
But
I
believe
there
was
a
specific
requirement
of
the
agency
on
Section
18
process
related
to
FQPA,
and
I'm
not
sure
that
we
talked
about,
you
know,
specifically,
you
know,
what
those
statutory
requirements
were
and
the
agency's
performance
on
that.
Maybe
it
has
already
long
ago
been
done,
but
I
just
can't
remember
that.
MS.
MULKEY:
A
quick
answer
to
that
is,
we
were
required
to
set
up
a
process
for
setting
tolerances.
We
did.
We
did
it
by
rule.
i
think
we
finalized
the
rule.
And
we
feel
like
we've
fully
implemented
that.
MR.
VROOM:
And
that's
all
working
fine
now,
right?
MS.
MULKEY:
Uh­
huh.
MR.
VROOM:
Okay.
Sorry.
MALE
SPEAKER:
Can
I
clear
up
a
point
of
information?
MS.
MULKEY:
Sure.
MALE
SPEAKER:
Was
this
proposal
­­
these
three
reforms
were
a
proposal
brought
by
AAPCO,
is
that
right?
And
so
to
the
extent
there
was
any
pressure,
it
was
brought
by
the
states
for
a
variety
of
reasons,
is
that
right?
FEMALE
SPEAKER:
(
Inaudible).
MALE
SPEAKER:
Okay.
Okay.
MS.
MULKEY:
Well,
this
­­
your
interest
in
this
has
presented
us
with
a
time
management
challenge,
but
in
every
other
way
has
been
very
helpful.
The
lessen
I
learned
from
this
is
that
there
is
still
an
interest
in
this
topic,
that
it
has
not
become
ho
hum
despite
the
maturation
of
all
our
experience
in
this
area.
We
anticipate
that
we
will
go
through
a
proposal
process,
as
we
described.
We
can
factor
your
input
today
into
that
proposal
process,
and
we'll
do
so
as
we
heard
it
and
as
it
seems
appropriate,
including
in
solicitation
of
comments
as
well
as
in
the
proposal.
One
of
the
lessons
I
heard
is
that
we
probably
have
a
challenge
around
transparency
regarding
the
Section
18
process
that
we've
not
fully
met,
because
I
heard
some
perceptions
from
multiple
sources
that
seemed
to
me
not
to
jive
completely
with
what
we
understand
to
be
reality.
And
so
maybe
this
is
also
an
opportunity
for
us
to
do
more
to
reveal
some
of
the
basics
and
content
about
how
the
process
works,
and
what
the
criteria
are,
and
what
the
circumstances
are,
and
also
what
our
experience
is
as
it
relates,
for
example,
to
old
chemistry
versus
new
chemistry
or
other
kinds
of
issues
like
that.

So
I
think
we
can
factor
all
that
in
from
your
input.
I
want
to
also
thank
the
panelists,
who
I
thought
were
terrific
and
gave
us
this
kind
of
multiple
perspective
which
allowed
us
to
kick
off
this
very
useful
dialogue.
Now,
with
respect
to
our
time
management
problems,
we're
going
to
take
our
break
now.
We
really,
really
must
be
back
at
five
till.
The
next
panel
has
a
challenge
because
of
their
continued
availability,
at
least
some
of
the
members.
So
during
the
break,
we're
going
to
sort
through
how
we
manage
the
next
one.
We
have
ample
total
time
left
to
us.
The
challenge
is
just
in
what
order
we
do
things.
But
if
we
don't
sit
back
down
by
five
minutes
till
and
not
a
minute
later
­­
(
Whereupon,
a
brief
recess
was
taken.)
MS.
MULKEY:
­­
our
information
may
be,
or
at
least
our
statement
of
opinions
and
positions
may
be.
The
timetable
works
and
Joe
has
been
very
gracious
to
agree
to
do
his
conclusion
of
the
updates
in
a
minute
after
this
next
panel.
So,
Anne,
if
you
could
kick
off
the
next
panel.
MS.
LINDSAY:
Okay.
This
session
we've
actually
got
two
panels.
We'll
start
off
with
a
panel
composed
of
various
different
government
officials,
each
of
whom
had
some
role
to
play
in
a
set
of,
I
think,
unfortunate
misuse
occurrences
from
last
year.
That
will
include
George
LaRocca,
who
is
a
product
manager
in
our
Registration
Division,
and
actually
as
product
manager
has
responsibility
for
some
of
the
chemicals
that
were
actually
involved.
Van
Kozak,
a
little
bit
to
my
farther
right,
who
is
one
of
our
regional
pesticide
managers
located
in
Dallas.
He
has
actually
also
been
a
headquarters
person
and
a
state
official,
so
he's
got
a
fully
rounded
perspective.
And
Phil
Benedict,
who
is
in
charge
of
pesticides
for
the
State
of
Vermont,
and
again
with
one
of
the
episodes
that
you'll
hear
had
some
direct
hands
on
and
involvement.
And
then
Terry
Troxell
will
complete
­­
from
FDA
will
complete
the
government
panel
perspective.

After
that
we
would
move
to
sort
of
a
short
reaction
panel
that
will
include
some
reactions
from
Dan
Botts
on
the
grower
perspective,
Shelley
Davis
­­
well,
Shelley
I
actually
expect
will
bring
in
some
other
aspects
of
misuse
that
we
won't
have
heard
up
until
that
point.
And
you'll
find
at
your
place
another
background
paper
that
I
think
has
helped
to
inform
some
of
the
thoughts
that
Shelley
is
going
to
share
with
us.
So
you
may
want
to
take
a
look
at
that.
And
then
Jay
Vroom,
when
he's
back,
will
be
the
wrap
up
for
the
reaction
panel.
And
then
just
as
we
did
with
the
last
session,
there
will
be
some
opportunity
to
go
around
the
table
and
get
some
insights
from
the
rest
of
you.
Both
for
the
future,
how
can
we
do
better
with
these
misuse
incidents,
and
probably
more
importantly,
how
can
we
actually
work
together
to
prevent
the
occurrence
of
these
kinds
of
events.
So
with
that,
I
would
like
to
hand
it
over
­­
MS.
MULKEY:
Just
hold
on
a
minute.
I
was
hoping
that
before
you
started
­­
it's
going
to
be
hard
for
Jay,
Dan
and
Shelley
to
react
­­
MS.
LINDSAY:
When
they're
not
here?
MS.
MULKEY:
Yes.
So
I
was
hoping
that
getting
this
started
would
have
the
salutary
effect
of
at
least
the
three
of
them.
FEMALE
SPEAKER:
Here's
Shelley.
Here
comes
Jay.
MS.
MULKEY:
Okay.
FEMALE
SPEAKER:
Who
else
do
we
need?
MALE
SPEAKER:
Dan.
MS.
MULKEY:
Dan
and
Shelley.
Oh,
there's
Shelley.
All
right.
Well,
two
out
of
three
is
probably
okay.
MALE
SPEAKER:
He
has
already
made
up
his
mind
what
he
wants
to
say,
anyway.
You
know
Dan.
MS.
MULKEY:
Yeah,
okay.
Okay,
Anne.
MS.
LINDSAY:
Okay.
So
with
that,
George
is
going
to
start
and
actually
try
to
give
you
a
fairly
succinct
MR.
LAROCCA:
Thank
you.
Between
May
and
September
of
last
year,
a
number
of
EPA
people,
including
myself,
spent
quite
a
bit
of
time
on
misuse
incidents
that
occurred
in
several
states
throughout
the
country.