Document ID: EPA-HQ-OPP-2002-0231-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-08T04:00Z

Page
1
of
22
April
7,
2003
Guidance
Document
to
Applicants:
FIFRA
Section
18
Pilot
Program
Concerning
(
1)
the
Streamlined
Application
Process
for
Select
Repeat
Emergency
Exemption
Requests
and
(
2)
the
Tiered
Evaluation
Criteria
for
Assessing
"
Significant
Economic
Loss"

This
document
is
intended
to
provide
guidance
to
State
and
Federal
agencies
which
submit
applications
for
specific
emergency
exemption
requests
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
under
the
limited
pilot
program
beginning
with
the
2003
use
season.
The
Agency
is
piloting
two
initiatives
related
to
the
emergency
exemption
process.
The
pilot
initiatives
may
reduce
the
burden
to
both
applicants
(
State
and
Federal
agencies)
and
the
EPA
in
connection
with
the
preparation
and
evaluation
of
exemption
requests.
The
pilot
will
not
diminish
health
and
safety
protections,
but
it
is
anticipated
that
actions
submitted
under
the
pilot
can
be
processed
more
quickly
by
the
Agency.

This
document
explains,
in
detail,
the
two
areas
that
will
be
piloted
and
describes
the
steps
that
applicants
should
take
in
order
to
participate
in
this
pilot
program.
The
Federal
Register
Notice
and
this
guidance
document
contain
eligibility
criteria
that
describe
the
type
of
exemption
requests
suitable
for
the
pilot
initiatives.
The
two
aspects
of
the
pilot
involve
different
criteria.
Applicants
should
carefully
review
this
document
and
the
Federal
Register
Notice
to
determine
whether
a
contemplated
exemption
request
is
eligible
for
the
pilot.

The
first
area
that
will
be
piloted
will
allow
applicants
for
certain
repeat
exemptions
to
re­
certify
that
the
emergency
conditions
which
initially
qualified
for
an
exemption
continue
to
exist.
Under
the
pilot
for
this
area,
the
applicants'
own
certification
that
the
emergency
situation
is
ongoing,
along
with
their
incorporation
by
reference
of
their
earlier
full
application,
will
take
the
place
of
the
submission
of
data
generally
required
to
support
a
repeat
request
for
an
emergency
exemption.
In
this
way,
the
burden
associated
with
the
application
process
for
select
repeat
requests
will
be
significantly
reduced.
In
order
to
initiate
this
area
of
the
pilot
immediately,
EPA
has
identified
the
specific
uses
(
pesticide
active
ingredient­
crop
combinations)
and
states
that
meet
the
criteria
and
are
eligible
for
this
aspect
of
the
pilot
this
year
(
see
Appendix
No.
1).

The
second
area
that
will
be
piloted
involves
revising
the
analytical
methodology
and
economic
data
necessary
to
assess
whether
a
"
significant
economic
loss"
will
occur.
Such
evaluations
are
typically
needed
to
support
applications
for
specific
emergency
exemption
requests.
Under
the
pilot,
EPA
will
assess
whether
a
"
significant
economic
loss"
will
occur
through
a
tiered
approach.
Successive
tiers
will
require
more
data
and
analysis.
However,
it
is
thought
that
many
"
significant
economic
loss"
findings
can
be
made,
without
loss
of
reliability,
using
less
data
and
analytical
resources
(
by
both
the
applicant
and
EPA)
than
the
process
currently
requires.

There
are
two
sections
to
this
document,
one
for
each
of
the
two
initiatives
under
the
pilot.
Questions
about
the
pilot,
or
the
section
18
process
in
general,
can
be
directed
to
Mr.
Dan
Rosenblatt,
Emergency
Response
Team
at
(
703)
308­
9366
or
by
e­
mail
at
rosenblatt.
dan@
epa.
gov
or
Sec­
18­
Mailbox@
epamail.
epa.
gov.
Page
2
of
22
Section
18
Pilot
­
Issue
No.
1
Streamlined
Application
Process
for
Select
Repeat
Requests
Introduction
The
regulations
governing
section
18
of
FIFRA,
allow
the
Agency
to
issue
a
specific
exemption
for
"...
as
long
a
period
as
is
reasonably
expected
to
be
necessary
but
in
no
case
for
longer
than
1
year."
(
40
Code
of
Federal
Regulations
C.
F.
R.
166.28(
a)).
Therefore,
EPA
has
reviewed
exemption
requests
on
a
year­
to­
year
basis,
and
required
applicants
to
submit
a
complete
application,
along
with
all
supporting
documentation,
each
year.
This
requirement
has
been
in
place
even
if
the
situation
is
one
which
could
reasonably
be
expected
to
recur
in
subsequent
years.
However,
EPA
recognizes
that
some
emergency
situations
continue
until
the
circumstances
which
precipitated
the
emergency
somehow
change.

In
light
of
these
considerations,
a
streamlined
application
program
is
being
piloted
beginning
with
the
2003
use
season.
Under
the
pilot,
for
certain
eligible
repeat
requests,
applicants
will
be
permitted
to
certify
that
the
conditions
which
brought
about
the
emergency
situation
continue
to
exist.
The
applicants'
(
i.
e.
the
state
or
federal
lead
agency
for
pesticides)
own
certification
and
incorporation
by
reference
of
their
earlier
full
application
is
intended
to
take
the
place
of
a
new
and
complete
exemption
request.
For
the
group
of
eligible
repeat
requests,
therefore,
it
is
expected
that
this
pilot
program
will
decrease
the
burden
associated
with
developing
and
submitting
an
application
for
an
emergency
exemption
for
the
eligible
repeat
requests.
Additionally,
it
is
anticipated
that
these
changes
will
lead
to
less
Agency
review
time
and
more
rapid
response
on
eligible
requests,
which
will
better
support
growers
and
the
public
in
addressing
emergency
pest
problems.

Under
this
portion
of
the
pilot
program,
EPA
has
identified
the
uses
and
states
which
are
eligible,
during
the
2003
use
season,
to
support
a
repeat
exemption
request
by
the
applicants'
own
certification
that
the
emergency
condition
is
ongoing.
The
list
of
uses
and
states
which
are
eligible
for
this
portion
of
the
pilot
are
provided
in
Appendix
No.
1
to
this
document.
In
developing
the
uses
included
in
Appendix
No.
1,
EPA
used
the
criteria
discussed
in
the
Federal
Register
Notice
and
reiterated
below.
All
four
criteria
were
measured
against
the
pool
of
requests
submitted
during
the
previous
use
season.

The
criteria
are
presented
here
so
that
applicants
and
the
public
can
better
understand
the
manner
in
which
the
initiatives
described
in
the
Federal
Register
Notice
could
be
applied
to
existing
emergency
pest
control
programs.

I.
Eligibility
Criteria
for
Streamlined
Application
Pilot
for
Repeat
Section
18
Emergency
Exemptions
All
four
of
the
conditions
listed
below
should
be
met
before
an
emergency
exemption
request
will
be
considered
eligible
for
the
streamlined
application
pilot.

1.
EPA
granted
the
same
exemption
the
previous
year,
and
it
is
the
second
or
third
year
of
the
request
by
that
applicant.
The
Agency
determined
that
the
situation
the
previous
Page
3
of
22
year
satisfied
requirements
for
an
emergency
condition
[
40
CFR
166.3(
d)].
A
complete
application
will
be
required
the
first
year
of
an
exemption
for
a
particular
applicant,
in
order
to
establish
the
existence
of
the
emergency.
Re­
certifications
will
not
be
accepted
as
the
basis
for
an
emergency
after
three
years
of
an
exemption
to
an
applicant.

2.
The
emergency
situation
can
reasonably
be
expected
to
continue
for
longer
than
one
year.
Examples
of
these
include
situations
where
a
registered
product
relied
upon
by
growers
becomes
permanently
unavailable;
expansion
of
a
pest's
range;
and,
documented
loss
of
efficacy
of
a
registered
product.
Situations
which
would
not
be
expected
to
continue
would
include
a
temporary
supply
problem
of
a
registered
product;
an
isolated
weather
event;
and,
a
sporadic
pest
outbreak.

3.
The
request
is
not
for
a
new
chemical,
a
first
food
use,
or
for
a
chemical
under
Special
Review.
A
request
that
is
for
a
chemical
which
has
never
been
registered
as
a
pesticide
under
Section
3
of
FIFRA,
or
has
never
been
registered
for
a
food
use,
or
the
chemical
has
officially
been
placed
under
Special
Review
by
the
Agency,
would
not
be
considered
for
candidacy
for
re­
certification
of
the
emergency.

4.
The
requested
pesticide
is
registered
for
another
use
and
has
been
designated
as
"
reduced­
risk"
by
EPA
for
one
or
more
uses.
The
reduced
risk
program
is
explained
in
PR
Notice
97­
3.
This
program
offers
pesticide
manufacturers
incentives
for
developing
registration
applications
for
pesticides
which
are
less
risky
than
the
alternatives
for
a
given
pest
problem.
A
committee
of
EPA
scientists
evaluates
and
selects
pesticides
and
uses
which
are
considered
to
be
reduced
risk.

On
a
case­
by­
case
basis,
EPA
will
review
with
applicants
whether
other
repeat
requests,
not
listed
in
Appendix
No.
1,
meet
all
of
the
criteria
listed
here.
Applicants
who
believe
there
are
additional
uses
that
should
be
added
to
Appendix
No.
1
should
contact
the
Agency.

II.
Schedule
and
Purpose
of
the
Pilot
Program
for
the
Streamlined
Application
Process
for
Repeat
Requests
EPA
is
initiating
this
pilot
in
order
to
(
1)
gain
experience
with
specific
approaches
for
modifying
the
section
18
program
and
(
2)
take
steps
to
put
into
place
specific
initiatives
that
have
been
suggested
by
key
stakeholders.
The
Agency
has
determined
that
it
will
publish
a
proposed
rule
concerning
the
emergency
exemption
process.
EPA
will
consider
any
available
information
from
this
pilot
as
it
proceeds
with
rulemaking.
At
this
time,
EPA
is
reserving
the
possibility
of
continuing
this
pilot
program
for
a
time
frame
that
extends
beyond
the
2003
growing
season,
modifying
the
pilot
in
the
future,
or
ending
it
following
this
initial
pilot
year.

As
mentioned
in
the
Federal
Register
Notice,
EPA
will
use
existing
avenues,
such
as
the
Pesticide
Program
Dialogue
Committee
and
SFIREG
to
obtain
informal
feedback
and
provide
information
to
stakeholders
and
the
public
about
experiences
gained
under
this
pilot.
Prior
to
the
start
of
the
2004
season,
EPA
will
directly
inform
applicants
about
the
outcome
of
the
initial
year
of
this
pilot
and
the
determination
on
whether
this
pilot
program
will
continue
in
this
same
fashion.
This
decision
will
be
based
on
the
experiences
of
applicants
and
the
Agency
concerning
this
initial
year
of
the
pilot
and
also
the
recommendations
and
comments
that
are
submitted
to
EPA
in
response
to
the
60
day
public
comment
period
announced
by
the
Federal
Register
Notice.
Page
4
of
22
III.
Overview
of
Schedule
and
Review
Cycle
for
Actions
Under
the
Streamlined
Application
Pilot
An
emergency
exemption
request
that
meets
the
criteria
outlined
in
the
Federal
Register
Notice
will
be
eligible
for
streamlined
application
and
"
re­
certification"
of
the
emergency
situation
for
two
years
following
the
initial
year
of
the
exemption
for
that
applicant.
If
an
emergency
continues
beyond
three
years
for
an
applicant,
they
will
again
be
required
to
submit
a
complete
request
each
year,
thereafter,
with
full
supporting
documentation
described
under
40
C.
F.
R.
166.20.
Other
applicants
will,
likewise,
be
eligible
for
streamlined
application
and
re­
certification
in
the
second
and
third
years
that
they
are
experiencing
the
emergency
situation.
However,
EPA's
initial
operational
design
for
this
program
suggests
that
long­
running
emergency
exemption
uses
might
not
be
appropriate
candidates
for
this
pilot.

As
part
of
the
review
of
an
emergency
exemption
application,
EPA
makes
a
determination
about
whether
the
registrant
is
making
adequate
progress
toward
obtaining
a
full
label
for
the
requested
use.
That
evaluation
is
based
on
the
number
of
years
the
use
(
i.
e.
the
chemical­
crop
combination)
has
collectively
been
sought
under
the
emergency
exemption
program.

Once
the
data
necessary
to
support
the
full
registration
for
a
use
that
is
associated
with
an
emergency
exemption
request
are
submitted,
the
Agency
puts
an
explicit
emphasis
on
quickly
evaluating
those
data
in
hopes
of
eliminating
the
need
for
a
long­
running
emergency
exemption
request.
Nonetheless,
there
are
instances
when
an
emergency
use
will
not
receive
its
registration
for
a
number
of
years
while,
simultaneously,
the
pest
problems
experienced
by
the
agricultural
sector
have
remained
ongoing.
In
general,
EPA
might
consider
that
a
particular
use
(
i.
e.
chemical­
crop
combination)
that
has
been
sought
for
the
past
six
years
might
be
too
long­
standing
to
be
eligible
for
inclusion
in
the
streamlined
application
portion
of
the
pilot.

EPA
believes
that
most
all
candidates
for
re­
certification
can
be
registered
relatively
quickly.
Pesticide
producers
should
place
a
high
priority
on
efforts
aimed
at
seeking
a
full
registration
for
a
product
that
is
sought
under
an
emergency
exemption.
Over
the
past
years,
a
large
number
of
emergency
exemption
requests
have
successfully
been
eliminated
due
to
registration
decisions
which
make
the
use
available
through
a
full
label.
Moving
forward,
this
will
be
a
continuing
emphasis
within
the
Agency.
Decisions
on
future
registration
work
planning
and
scheduling
will
continue
to
bias
and
support
the
review
of
uses
associated
with
emergency
uses.
Also,
of
note,
the
pilot
is
limited
to
reduced
risk
pesticides.
Thus,
there
is
a
high
likelihood
that
the
registration
and
regulatory
issues
associated
with
obtaining
a
full
registration
for
the
subject
use
can
be
addressed.
EPA
will
continue
to
evaluate
this
issue
in
its
design
and
operation
of
the
pilot
program
and
also
plans
on
addressing
it
in
the
proposed
rule.

The
Agency
continues
to
encourage
applicants
to
submit
requests
for
re­
certification
of
the
emergency
situation
with
sufficient
lead
time
necessary
to
process
the
request
in
advance
of
the
use
season.

EPA
will
establish
time­
limited
tolerances
to
support
use
of
a
chemical
for
the
appropriate
period
of
time
in
a
situation
where
the
emergency
pest
problem
is
ongoing.
As
is
currently
the
case
with
all
section
18s
issued,
the
applicant
is
responsible
for
enforcing
all
aspects
of
the
emergency
program.
Also,
note
that
EPA
retains
the
authority
to
revoke
an
exemption
if
necessary
(
40
C.
F.
R.
166.35.).
Page
5
of
22
Specific
Proposed
Time
Line
for
Eligible
Repeat
Requests
Year
#
1:

The
Applicant
will
submit
a
complete
emergency
exemption
application,
along
with
all
supporting
documentation.
EPA
will
conduct
a
comprehensive
review
to
determine
whether
the
request
meets
the
regulatory
criteria
for
an
emergency,
and
whether
the
use
would
pose
acceptable
risks
to
health
and
the
environment.
For
applications
involving
the
treatment
of
food,
EPA
will
also
determine
if
the
appropriate
safety
findings
can
be
made
with
respect
to
reasonable
certainty
of
no
harm
to
human
health
as
required
by
the
Food
Quality
Protection
Act,
and
establish
any
necessary
time­
limited
tolerances.

Years
#
2
and
#
3:

For
a
repeat
request
in
the
second
or
third
year
for
a
given
applicant,
that
applicant
will
have
the
opportunity
to
"
re­
certify"
that
the
emergency
situation
continues
to
exist.
The
applicant
must
certify
in
writing
that
the
emergency
situation
has
remained
unchanged
and
is
ongoing
and,
further,
that
they
wish
to
incorporate
by
reference
the
application
on
file
with
EPA
which
supported
the
emergency
use
initially.
An
example
"
re­
certification"
letter
is
included
in
this
guidance
as
Appendix
No.
2.

Additionally,
the
applicant
is
required
to
submit
a
detailed
section
18
exemption
pesticide
usage
report
for
the
previous
use
season.
Information
must
be
included
as
set
forth
at
40
C.
F.
R.
166.32,
and
the
applicant
will
also
address
the
effectiveness
of
the
exemption
program
for
the
previous
season.

EPA
would
review
the
"
re­
certification"
submitted
by
the
applicant,
as
well
as
the
most
recent
risk
evaluations
for
the
proposed
use,
and
consider
whether
any
alternatives
have
become
available,
to
ensure
that
the
requested
use
still
meets
the
criteria
for
approval.
If
these
conditions
have
remained
the
same,
and
the
use
pattern
is
unchanged,
the
Agency's
review
time
is
expected
to
be
significantly
reduced.

Note:
If
the
use
pattern
for
the
second
and
third
year
is
modified
in
any
way,
the
applicant
must
clearly
state
so
in
the
repeat
request.
A
change
in
the
use
pattern
will
likely
require
additional
review
to
reassess
the
estimated
risk
associated
with
the
use.
Any
changes
which
may
increase
exposure
will
require
that
the
risk
be
re­
evaluated
by
EPA,
and
may
undercut
the
ability
of
the
applicant
to
receive
an
expedited
decision.
Such
changes
may
include,
but
are
not
limited
to:
increased
application
rate
or
number
of
applications,
additional
method
of
application,
changes
to
pre­
harvest
or
re­
entry
intervals,
or
increase
in
total
number
of
acres
to
be
treated,
change
in
counties
or
geographic
area,
and
other
changes
in
directions
for
use.

If
the
use
pattern
is
changed
additional
documentation
must
be
submitted
along
with
the
certification
letter
that
will
support
the
proposed
change.
At
a
minimum
the
applicant
must
submit
revised
section
18
use
directions.
However,
additional
information
may
be
required
based
on
the
proposed
change.
For
example,
a
change
in
the
application
rate
or
the
PHI
may
require
the
time­
limited
tolerance
to
be
revised.
Yet,
even
though
change
in
the
use
pattern
will
likely
prevent
the
Agency
from
fully
expediting
the
request
through
the
re­
certification
program,
the
applicant
can
still
re­
certify
that
emergency
conditions
still
exist,
and
need
not
submit
a
complete
application
addressing
the
existence
of
the
emergency.
Page
6
of
22
If
the
use
pattern
is
the
same
as
in
the
first
year,
applicants
may
include
a
separate
certification
that
their
requested
use
pattern
has
not
changed
in
the
re­
certification
year,
and
incorporate
by
reference
all
use
pattern
specifications
submitted
in
a
previous
application
or
applications.
This
certification
of
an
unchanged
use
pattern
will
aid
in
expediting
the
Agency's
decision.

Year
#
4
and
beyond:

In
the
fourth
and
subsequent
years
of
an
exemption
to
a
particular
applicant,
a
complete
application
will
again
be
required
for
EPA's
comprehensive
review
to
determine
whether
it
meets
the
criteria
for
an
emergency
exemption.
Additionally,
after
the
first
3
years
of
use,
EPA
will
consider
whether
adequate
progress
toward
registration
is
being
made
[
40
C.
F.
R.
166.25(
b)(
2)(
ii)].
Page
7
of
22
Key
Considerations
for
the
Streamlined
Application
Pilot
Factors
to
be
Considered
by
Applicant
Factors
to
be
Considered
by
EPA
­
consider
whether
the
situation
is
an
ongoing
emergency
(>
1
year)

­
address
whether
any
alternatives
have
become
available
­
assess
experience
from
the
first
year
of
exempted
use,
and
whether
it
met
the
needs
of
the
situation
­
assess
whether
risk
to
human
health
and
the
environment
is
acceptable
or
has
changed
­
evaluate
progress
that
is
being
made
toward
registration
of
the
exempted
use
­
confirm
Applicant's
assertion
that
no
alternatives
have
become
available
­
consider
whether
the
Applicant
is
requesting
any
change
in
the
use
pattern
from
previous
year,
and
if
so,
the
effect
on
risk
Appendices
Numbers
1­
3
Support
the
Streamlined
Application
Pilot
for
Eligible
Repeat
Requests:

Appendix
No.
1:
List
of
eligible
uses
and
states.

Appendix
No.
2:
Proposed
generic
certification
letter
from
applicant
to
EPA
indicating
the
ongoing
nature
of
the
emergency
pest
situation.

Appendix
No.
3:
Example
model
format
of
EPA
authorization
of
a
repeat
exemption
that
can
be
re­
authorized
under
the
pilot.
Page
8
of
22
Section
18
Pilot:
Issue
No.
2
Alternative
Means
of
Supporting
"
Significant
Economic
Loss"
Determinations
for
Emergency
Exemption
Requests
Based
on
Tiered
and
Streamlined
Economic
Data
Introduction
EPA
is
initiating
a
pilot
program
concerning
its
approach
for
determining
significant
economic
loss,
in
the
context
of
FIFRA
Section
18
emergency
exemptions.
This
pilot
program
is
motivated
by
three
factors.
First,
the
Agency
hopes
to
reduce
the
burden
of
data
collection
and
analysis
on
the
part
of
the
States
and
the
Agency
in
cases
where
a
decision
can
be
made
with
less
information,
thus
speeding
decisions
for
these
cases
and
permitting
more
resources
to
be
devoted
to
more
complex
situations.
Second,
the
Agency
would
like
to
increase
transparency
and
establish
more
consistent
measures
of
economic
loss.
Third,
the
Agency
would
like
to
focus
the
determination
of
losses
due
to
emergencies
on
the
losses
caused
by
urgent
and
non­
routine
pest
problems
and
not
confound
the
issue
with
price
volatility
that
has
sometimes
made
the
criterion
of
significant
economic
loss
more
difficult
to
apply.

In
lieu
of
the
established
practice
involving
net
revenue
methodology
which
relies
on
five
historic
years
of
yield,
price,
cost,
and
revenue
data,
the
Agency
is
announcing
a
pilot
project
whereby
it
will
use
a
more
flexible,
tiered
approach
for
determining
significant
economic
loss,
intended
to
streamline
data
and
analytical
requirements.
An
analysis
of
past
Section
18
requests
suggests
that
this
approach
will
not
cause
a
significant
change
in
the
overall
likelihood
of
a
significant
economic
loss
finding,
but
may,
in
many
cases,
lead
to
savings
to
both
applicants
and
EPA
from
reduced
data
and
analytical
burdens.
In
particular,
these
assessment
methodologies
can
reduce
or
eliminate
the
need
for
production
cost
data
that
is
often
difficult
to
obtain
and
often
inappropriate
for
use.
Further,
the
tiered
system
will
be
more
flexible
in
using
price
data,
especially
when
historical
averages
do
not
reflect
the
current
situation.

Whereas
the
existing
method
generally
requires
detailed
historical
data,
under
the
pilot
approach
the
analytical
burden
for
determining
significant
economic
loss
is
divided
into
three
successive
tiers.
If
the
pest
situation
does
not
appear
likely
to
result
in
a
significant
economic
loss
based
on
the
first
tier
analysis,
it
may
qualify
based
on
further
analysis
in
succeeding
tiers.
Each
additional
tier
requires
more
data
and
involves
more
analysis
on
how
the
emergency
affects
profitability.
Each
tier
has
a
quantitative
threshold
that
will
generally
apply
to
all
emergency
exemption
applications.
In
rare
cases
the
Agency
may
also
make
a
significant
economic
loss
(
SEL)
finding
based
on
conditions
that
do
not
neatly
fit
the
criteria
for
three
tiers.

Similar
to
the
pilot
offered
for
repeat
requests,
only
emergency
exemption
applications
which
request
use
of
"
reduced­
risk"
pesticides
will
be
eligible
to
present
"
significant
economic
loss"
data
under
this
alternative
tiered
method
for
evaluating
economic
loss.
For
this
reason,
applicants
should
especially
consider
new
first
time
requests
under
section
18
for
this
area
of
the
pilot.
Applicants
"
opt
in"
to
this
portion
of
the
pilot
program.
Repeat
requests
would
not
necessarily,
be
good
candidates
for
this
portion
of
the
pilot
because
a
"
significant
economic
loss"
finding
will
have
already
been
made
for
the
use
under
the
existing
"
net
revenue"
assessment
model.
Nonetheless,
in
order
to
gain
experience
with
this
new
methodology,
applicants
may
support
repeat
requests,
provided
the
requested
pesticide
has
been
designated
and
registered
by
EPA
as
"
reduced
risk"
for
one
or
more
uses,
by
submitting
economic
data
that
is
responsive
to
one
of
the
three
tiers
described
in
the
Federal
Register
Notice
and
in
this
document.
The
list
of
pesticide
active
ingredients
that
are
considered
reduced
risk
is
provided
as
Appendix
No.
4.

Emergency
exemption
requests
that
are
supported
by
economic
data
described
in
this
pilot
initiative
continue
to
Page
9
of
22
be
subject
to
appropriate
health
and
environmental
standards
under
the
section
18
regulations
and
the
statutory
provisions
which
govern
pesticide
use
and
food
safety.

This
document
summarizes
the
Agency's
positions
and
policies
regarding
the
evaluation
of
significant
economic
loss.
It
does
not
address
other
issues
associated
with
emergency
exemptions,
and
it
is
not
intended
to
supplant
the
Section
18
regulations
at
40
CFR
part
166.
It
is
meant
to
clarify
certain
parts
of
the
existing
regulations,
to
clarify
how
the
Agency
will
analyze
data
and
determine
significant
economic
loss,
and
to
serve
as
additional
guidance
to
Federal
and
State
agencies
submitting
Section
18
emergency
exemption
requests.

I.
Demonstration
of
Significant
Economic
Loss
EPA
defines
"
significant
economic
loss"
as
a
substantial
reduction
in
expected
profitability
of
crop
production
in
the
area
affected
by
the
emergency.
40
CFR
§
166.3(
h).
As
an
emergency,
the
pest
situation
causing
the
losses
could
not
have
been
anticipated
and
addressed
through
the
regular
registration
process
and
must
fall
outside
the
bounds
of
the
normally
expected
pest
populations.
Such
a
situation
might
arise
due
to
abnormal
weather
conditions,
unexpected
resistance
to
usual
pest
control
practices,
or
loss
of
a
pest
control
product
due
to
regulation,
market
disruption
or
a
marketing
decision
by
the
product
source.

A.
Cause
of
an
expected
loss
According
to
the
regulations
at
40
CFR
§
166.3(
h),
only
losses
caused
by
the
emergency
conditions
are
relevant
in
determining
expected
economic
losses.
Losses
due
to
changes
in
the
output
market
do
not
qualify,
nor
do
losses
due
to
conditions
other
than
the
pest
situation.
For
example,
losses
due
to
abnormal
weather
conditions
cannot
be
addressed
by
pesticide
policy,
even
if
those
losses
also
cause
an
unexpected
pest
situation.
Only
those
losses
directly
attributable
to
the
pest
can
be
claimed.
That
is,
if
a
drought
were
to
result
in
a
pest
outbreak,
the
emergency
would
be
the
pest
outbreak
and
the
baseline
yield
would
be
that
expected
under
a
drought
situation
but
without
the
pest.

B.
Evaluating
the
significance
of
an
economic
loss
EPA
has
been
evaluating
the
significance
of
an
anticipated
economic
loss
by
determining
if
net
revenues
per
acre
for
the
current
year
fall
within
the
normal
range
of
variation,
defined
as
grower
profits
over
the
most
recent
five
years.
If
net
revenues
fall
within
the
historical
range,
the
expected
loss
is
not
considered
by
the
Agency
to
be
significant,
since
it
would
not
exceed
what
would
be
expected
as
a
result
of
normal
fluctuations
over
a
number
of
years.
However,
if
prices
for
the
commodity
fluctuate
widely
over
time,
growers
face
a
higher
standard
of
loss
and
may
be
inadvertently
penalized
when
pest
problems
result
in
higher
than
normal
yield
losses.

EPA
believes
a
better
system
would
be
to
determine
the
significance
of
economic
losses
by
comparing
the
situation
that
would
be
expected
in
the
absence
of
the
emergency
situation
to
the
situation
expected
to
occur.
The
tiered
system
sets
relatively
high
thresholds
of
loss
in
lower
tiers
that,
if
verified,
will
lead
to
a
finding
of
significance
with
only
biological
information
or
a
minimal
amount
of
economic
data.
A
lower
threshold
of
loss
is
set
for
the
final
tier
that
will
require
no
more
data
than
is
currently
demanded.

1.
Tier
1,
Yield
Loss
Tier
1
is
based
on
crop
yield
loss
and
is
a
quantity­
based
measure.
EPA
will
conclude
that
a
significant
economic
loss
will
occur
if
the
projected
yield
loss
due
to
the
emergency
condition
is
verified
to
be
20%
Page
10
of
22
of
expected
yields
or
greater.
The
yield
loss
threshold
in
Tier
1
will
be
the
same
for
all
crops
and
regions.
This
threshold
is
set
at
a
level
such
that
a
loss
which
exceeds
the
threshold
would
generally
also
meet
the
thresholds
in
Tiers
2
and
3,
if
the
additional
economic
data
were
submitted
and
analyzed.
Therefore,
for
large
yield
losses
it
is
not
necessary
to
separately
estimate
economic
loss,
which
requires
detailed
economic
data.
Yield
losses
are
measured
as
the
difference
between
expected
yields
in
the
absence
of
the
emergency
and
yields
under
the
emergency
condition
when
using
the
best
available,
registered
alternative.

2.
Tier
2,
Economic
Loss
as
Percentage
of
Gross
Revenues
For
situations
with
yield
losses
that
do
not
meet
the
yield
loss
criterion
for
Tier
1,
EPA
will
evaluate
estimates
of
economic
loss
as
a
percent
of
gross
revenue
in
Tier
2.
In
addition
to
yield
losses
there
may
be
other
impacts
that
affect
economic
loss,
including
quality
losses
and
changes
in
production
costs,
including
pest
control,
harvesting,
sorting
and
processing.
EPA
will
conclude
that
a
significant
loss
will
occur
if
the
projected
losses
due
to
the
emergency
condition
are
verified
to
be
20%
of
expected
gross
revenues
or
higher.
This
threshold
will
be
the
same
for
all
crops
and
regions.
Quality
losses
occur
when
damage
results
such
that
the
commodity
fails
to
meet
the
market
standards
for
a
high­
value
segment
(
e.
g.,
export
or
fresh
market)
and
must
be
sold
in
a
lower
value
outlet
(
e.
g.,
domestic
or
processed
market).
Quality
losses
can
occur
without
loss
in
quantity
or
can
occur
in
conjunction
with
yield
losses.
This
tier
will
also
consider
losses
due
to
higher
production
costs.
Higher
production
costs
could
include
additional
pest
control
costs,
for
example,
mechanical
weeding,
or
additional
harvest
costs,
for
example,
sorting
into
different
grades.
However,
these
costs
must
be
a
result
of
the
emergency
before
the
expenses
can
be
included
in
the
projected
loss.

3.
Tier
3,
Economic
Loss
as
Percentage
of
Net
Revenues
For
situations
in
which
losses
do
not
meet
the
criteria
for
Tiers
1
and
2,
EPA
will
evaluate
estimates
of
economic
loss
as
a
percent
of
net
revenue
in
Tier
2.
Economic
losses
are
defined
as
in
Tier
2.
EPA
will
conclude
that
a
significant
loss
will
occur
if
the
projected
losses
due
to
the
emergency
condition
are
50%
of
expected
net
revenues
or
higher.
This
threshold
will
be
the
same
for
all
crops
and
regions.
For
this
purpose,
the
Agency
defines
net
revenue
as
gross
revenues
less
variable
operating
costs
(
purchased
inputs
and
hired
labor).
The
Agency
considers
only
variable
operating
costs
because
these
costs
are
easier
to
measure
and
document
than
fixed
costs,
such
as
overhead
and
depreciation
of
machinery,
and
because
they
are
likely
to
be
more
reflective
of
short­
term
impacts
due
to
emergency
conditions.

4.
Other
considerations
The
Agency
recognizes
that
in
certain
situations,
significant
economic
losses
may
not
be
demonstrated
using
the
approach
outlined
above.
It
is
the
applicant's
responsibility
to
explain
all
relevant
issues
and
provide
justification
for
an
alternative
estimate
of
losses.

For
example,
in
evaluating
the
significance
of
an
economic
loss
for
production
activities,
the
Agency
may
also
consider
whether
the
loss
could
affect
the
long­
term
financial
viability
expected
for
the
activity.
If
the
emergency
situation
does
not
lead
to
immediate
economic
losses
but
can
be
shown
to
significantly
affect
the
life­
span
of
a
perennial
crop
(
e.
g.,
an
orchard
or
vineyard)
or
the
ability
to
continue
to
cultivate
an
annual
crop
(
e.
g.,
permanent
establishment
of
a
soil­
borne
pathogen)
such
that
significant
economic
loss
is
likely
in
the
near
future,
the
Agency
may
grant
the
requested
exemption.
Multi­
crop
pest
management
strategies,
where
treatment
would
be
better
applied
to
pests
on
one
crop
to
avoid
damage
to
another
crop,
can
also
be
considered
with
proper
data.
Page
11
of
22
II.
Emergency
Exemption
Applications
The
EPA
will
base
its
determination
of
yield
and/
or
economic
loss
on
the
expected
or
average
losses
per
acre
anticipated
to
occur
on
affected
acreage
(
the
area
for
which
the
emergency
exemption
is
requested),
not
the
maximum
possible
losses.
The
Agency
believes
that
as
a
matter
of
public
policy,
the
average
is
the
appropriate
measure
with
which
to
balance
the
benefits
accruing
from
the
use
of
pesticides
with
any
human
or
ecological
risks
that
might
arise.

A.
Documentation
of
the
Emergency
The
application
must
include
an
explanation
of
the
events
that
brought
about
the
emergency
pest
pressures
(
weather
conditions,
resistence
development,
pesticide
cancellation,
etc.).
Claims
of
abnormal
pest
or
disease
pressure
must
be
documented
with
data
or
written
testimony
of
qualified
experts.

B.
Documentation
of
Yield
Loss
(
Tiers
1
and
above)

The
EPA
would
prefer
that
the
requests
for
an
emergency
exemption
be
based
upon
the
expected
or
average
yield
and/
or
economic
losses
anticipated
to
occur
on
affected
acreage
(
the
area
for
which
the
emergency
exemption
is
requested),
not
the
maximum
possible
losses.
If
no
estimate
of
average
losses
can
be
made,
the
agency
requests
both
maximum
possible
losses
and
that
loss
that
is
most
frequently
observed
(
the
mode
of
the
distribution).
If
available,
the
minimum
yield
loss
anticipated
on
the
affected
acreage
can
be
helpful
in
describing
the
distribution
in
losses
that
may
result
from
the
emergency
situation.
Yield
loss
estimates
may
be
sufficient
for
a
finding
of
significant
economic
loss
at
Tier
1,
if
they
are
verifiably
equal
to
or
greater
than
20%
of
the
expected
yields,
or
the
estimates
may
form
the
basis
for
findings
at
later
stages
in
the
review.

Applications
should
include
the
yield
that
would
be
expected
if
no
emergency
existed,
or
the
baseline
yield.
This
estimate
may
be
based
on
a
historical
average
or
other
information.
The
former
is
likely
to
be
easier
to
document.
If
based
on
other
information,
it
should
be
documented
that
the
estimate
is
for
the
most
likely
yield
and
not
the
maximum
possible.
Yield
losses
can
be
expressed
in
absolute
terms
or
as
percentage
of
the
expected
yield.
Losses
incurred
as
a
result
of
the
emergency
should
reflect
only
the
losses
that
would
be
expected
if
growers
use
the
best
available
(
registered)
means
of
control.

Loss
estimates
must
be
verifiable.
The
Agency
would
prefer
to
see
comparative
product
performance
studies
of
the
efficacy
or
yields
of
currently
registered
pesticides,
if
any,
and
potential
alternatives.
If
unavailable,
noncomparative
product
performance
studies
of
various
pesticides
compared
to
untreated
control
plots
can
also
be
used
to
verify
yield
loss
claims.
Economic
injury
studies
documenting
the
relationship
between
pest
populations
and
yield
loss
may
be
acceptable,
particularly
if
no
alternative
control
method
is
available.
At
the
Tier
1
level,
the
Agency
will
not
usually
accept
informal
monitoring
of
pest
damage
and
associated
yield
losses
or
expert
opinion
unless
well
documented
and
independently
verifiable.
Such
studies
may
be
acceptable
in
conjunction
with
economic
data
verifying
gross
or
net
revenue
losses.

C.
Documentation
of
Economic
Loss
and
Gross
Revenues
If
a
request
cannot
be
granted
solely
on
the
basis
of
yield
loss,
because
losses
are
below
the
threshold
or
are
based
on
data
that
does
not
meet
verification
standards,
it
will
be
reviewed
at
Tier
2,
provided
sufficient
economic
data
have
been
included.
The
Agency
defines
economic
losses
as
originating
from
one
or
more
of
three
sources:
yield
or
quantity
losses,
quality
losses
that
reduce
the
price
received,
and
Page
12
of
22
changes
in
production
costs
due
to
the
emergency.
These
losses
are
compared
to
the
gross
revenues
that
would
be
expected
without
the
emergency
situation,
that
is,
the
baseline
gross
revenues.
Losses
of
20%
or
more
meet
the
criteria
for
significant
economic
loss.

Baseline
gross
revenues
are
calculated
by
multiplying
the
baseline
yield
(
see
Section
B,
above)
with
the
expected
price:
GR
0
=
P
0

Y
0.
The
expected
price
may
be
calculated
as
the
historical
average
or
some
other
price
if
it
is
justified
as
more
appropriate.
Examples
of
acceptable
prices
are
the
futures
price
for
the
commodity,
contract
price
or
current
market
prices.
The
source
of
these
prices
should
be
documented,
for
example,
USDA
statistics
or
market
reports.
In
all
cases,
the
application
should
consider
any
government
price
supports,
for
example,
as
established
in
the
2002
Farm
Bill,
to
determine
the
value
of
the
commodity
to
the
producer.

The
impact
of
yield
loss
on
gross
revenue
is
straightforward.
The
percentage
loss
of
revenues
is
equal
to
the
percentage
loss
of
yield
when
no
price
changes
resulting
from
the
emergency
are
anticipated.

Economic
losses
can
also
result
from
changes
in
production
costs,
including
additional
pest
control
costs
and
higher
harvesting
and
sorting
costs,
which
would
not
occur
in
the
absence
of
the
emergency.
These
extra
production
costs,
including
alternative
chemical,
biological
or
mechanical
measures,
can
be
documented
by
economic
studies
or
other
verifiable
sources.
An
example
is
provided
in
Table
1.
Suppose
losses
due
to
a
new
pest
infestation
could
be
as
high
as
60%
with
no
control,
but
may
be
mitigated
by
a
marginally
effective
registered
alternative,
which
would
normally
be
used
against
a
different
pest
at
a
different
growth
stage.
The
alternative
costs
$
100/
acre
including
application
costs.
According
to
studies,
losses
with
the
alternative
could
be
as
high
as
30%,
with
most
acreage
suffering
about
10%
losses.
Average
losses
for
the
affected
acreage
is
estimated
at
15%.
Economic
losses
are
calculated
at
$
370/
acre
($
270/
acre
due
to
yield
losses
and
$
100/
acre
in
additional
costs)
and
represent
over
20%
of
baseline
gross
revenues.
Table
1.
Example
of
economic
loss
due
to
yield
(
quantity)
losses
and
additional
pest
control
costs.

Baseline
Emergency
Change
Yield
(
ton/
acre)
15.0
12.8
­
15.0%

Price
($/
ton)
$
120.00
$
120.00
Gross
Revenue
($/
acre)
$
1,800.00
$
1,530.00
­
15.0%

Additional
Pest
Control
Costs
($/
acre)
$
100.00
Economic
Loss
($/
acre)
$
370.00
Economic
Loss/
GR
0
20.6%

Sources:
Yield
and
Price
data
from
State
Statistical
Service
(
date),
yield
losses
from
studies
conducted
at
State
Agricultural
Experiment
Station
(
researchers,
dates),
additional
pest
control
costs
from
estimates
by
local
applicators
(
documentation
included
in
request).
Note:
Shading
denotes
calculated
figures.

Calculation
of
quality
impacts
may
be
more
complicated.
The
baseline
price
(
P
0)
should
be
calculated
as
a
weighted
average
of
the
prices
of
different
grades
or
categories
(
P
i,
where
the
grades
are
denoted
i).
The
weights
are
the
percent
of
yields
that
usually
are
sold
in
each
grade,
that
is
Page
13
of
22
where
Y
i
is
the
quantity
per
acre
in
grade
i
and
Y
0
is
the
total
quantity
per
acre.
The
usual
distribution
of
yields
between
grades
can
be
documented
through
historical
data.
The
distribution
between
grades
due
to
the
emergency
should
be
documented
in
the
same
fashion
as
yield
losses
discussed
above.
The
emergency
price
(
P
E)
is
calculated
using
the
weights
calculated
as
a
result
of
the
emergency,
with
the
grade
prices
held
constant.

Table
2
provides
an
example
of
calculating
gross
revenue
losses
with
combined
yield
and
quality
losses
due
to
a
pest
outbreak
in
fruit
where
the
produce
may
be
sold
to
the
fresh
market,
processed
(
canning)
and
juice.
In
this
example,
yields
are
reduced
10%,
according
to
studies
at
the
Agricultural
Experiment
Station.
However,
25%
of
fruit
that
would
normally
be
sold
in
the
fresh
market
and
20%
of
fruit
normally
sold
to
processors
suffers
pest
damage
such
that
it
does
not
make
grade
and
is
culled
for
juice.
From
this
information,
new
weights
are
calculated
and
the
average
price
per
ton
for
the
fruit
is
calculated
under
the
emergency
situation.
The
result
is
a
13%
decline
in
price.
Taken
together
with
the
reduced
yield,
gross
revenues
are
calculated
to
decline
by
almost
22%.
The
economic
loss
is
calculated
as
the
difference
in
gross
revenue,
GR
0
­
GR
E,
where
GR
E
=
P
E

Y
E
.

Table
2.
Example
of
economic
loss
due
to
both
yield
(
quantity)
and
price
(
quality)
losses.

Baseline
Emergency
Change
Yield
(
tons/
acre)
16.3
14.7
­
10.0%

Yield,
fresh
(
tons/
acre)
8.2
6.1
­
25.0%

Weight
50.0%
41.7%

Price
($/
ton)
$
360.00
$
360.00
Yield,
processed
(
tons/
acre)
6.5
5.2
­
20.0%

Weight
40.0%
35.6%

Price
($/
ton)
$
220.00
$
220.00
Yield,
juice
(
tons/
acre)
1.6
3.3
105.0%

Weight
10.0%
22.8%

Price
($/
ton)
30.00
30.00
Average
Price
($/
ton)
$
271.00
$
235.06
­
13.3%

Gross
Revenue
($/
acre)
$
4,417.30
$
3,448.27
­
21.9%

Economic
Loss
($/
acre)
(
GR0
­
GRE)
$
969.04
21.9%

Sources:
Yield
and
Price
data
from
State
Statistical
Service
(
date),
weights
calculated
from
usage
figures
(
State
Statistical
Service),
yield
losses
from
study
conducted
at
State
Agricultural
Experiment
Station
(
researcher,
date).
Note:
Shading
denotes
calculated
figures.

D.
Documentation
of
Net
Revenues
Page
14
of
22
Requests
that
cannot
be
granted
at
Tiers
1
and
2
will
be
considered
against
a
standard
of
losses
as
a
percentage
of
net
cash
revenues,
provided
sufficient
data
are
provided.
Economic
losses
are
calculated
as
in
Part
C,
above,
as
a
combination
of
yield
(
quantity)
losses,
quality
losses
affecting
the
price
received,
and
additional
pest
control
costs.
If
these
losses
are
shown
to
be
50%
of
net
cash
revenues
or
more,
the
Agency
will
find
that
a
significant
economic
loss
has
occurred.
For
these
purposes,
the
Agency
defines
net
cash
revenues
as
the
difference
between
gross
revenues
and
variable
operating
expenses.
Variable
operating
expenses
include
purchased
inputs
and
hired
labor,
but
do
not
include
fixed
operating
costs
such
as
depreciation
of
machinery
and
infrastructure
or
amortized
establishment
costs.
The
Agency
believes
that
these
costs
are
most
likely
to
be
affected
by
short­
term
emergency
situations.
Further,
fixed
costs
per
acre
may
be
highly
heterogeneous
across
farms,
depending
on
size
and
diversification.
Finally,
the
Agency
wishes
to
avoid
problematic
issues
arising
from
negative
net
returns
that
have
sometimes
appeared
in
past
requests.
If
growers
are
unable
to
cover
their
variable
operating
costs
in
the
baseline
scenario,
the
Agency
will
question
the
economic
rationale
for
production.

Many
Land
Grant
institutions
publish
cost
of
production
or
crop
budgets.
However,
these
studies
may
include
fixed
costs
deemed
inappropriate
for
use
in
this
situation
or
may
not
be
completely
accurate
for
the
specific
area
suffering
the
emergency.
Some,
for
example,
may
be
more
reflective
of
high­
input
producers
than
typical
growers.
Any
changes
in
budget
figures
should
be
accompanied
by
an
explanation
as
to
the
reason
for
the
changes.
Likewise,
not
all
institutions
publish
studies
for
all
commodities,
but
if
neighboring
states'
budgets
are
reflective
of
growers'
costs,
those
data
are
likely
to
be
adequate.

Table
3
presents
an
example
of
a
calculation
of
losses
as
a
percentage
of
net
revenues.
In
this
scenario,
informal
monitoring
suggests
losses
averaging
around
25%
on
affected
acreage,
using
a
marginally
effective
alternative
that
costs
$
20/
acre.
Economic
losses
are
calculated
to
be
about
$
222.50/
acre.
This
yield
loss
would
be
sufficient
for
Tier
1,
except
for
the
fact
that
the
data
are
not
easily
verifiable.
Additional
economic
data
are
needed.
Operating
costs
are
shown
to
be
about
$
520/
acre,
leaving
net
cash
revenues
of
$
290/
acre
as
the
baseline.
Losses
therefore
represent
over
75%
of
net
cash
revenues,
and
support
a
finding
of
significant
economic
loss.

Table
3.
Example
of
losses
as
a
percentage
of
net
revenues.

Baseline
Emergency
Change
Yield
(
ton/
acre)
6.0
4.5
­
25.0%

Price
($/
ton)
$
135.00
$
135.00
Gross
Revenue
($/
acre)
$
810.00
$
607.50
­
25.0%

Additional
Pest
Control
Costs
($/
acre)
$
20.00
Economic
Loss
($/
acre)
$
222.50
Operating
Costs
($/
acre)
$
520.00
$
520.00
Net
Cash
Revenue
($/
acre)
$
290.00
$
67.50
Economic
Loss/
Net
Cash
Revenue
76.7%

Sources:
Yield
and
Price
data
from
State
Statistical
Service
(
date),
yield
losses
from
informal
monitoring
of
affected
fields
(
contact,
dates),
additional
pest
control
costs
from
estimates
by
local
applicators
(
documentation
Page
15
of
22
included
in
request),
operating
costs
from
cost
of
production
survey
by
Land
Grant
Institution
(
researcher,
date).
Note:
Shading
denotes
calculated
figures.

E.
Other
Information
The
Agency
recognizes
that
certain
situations
that
impose
significant
economic
losses
may
not
be
captured
by
the
analyses
outlined
above.
For
example,
the
Agency
acknowledges
that
failure
to
control
pests
may
not
result
in
immediate
yield
losses
but
could
lead
to
future
losses,
as
in
the
case
of
perennial
crops
weakened
by
pest
damage.
In
this
situation,
biological
and
economic
data
relevant
to
establishing
expected
long­
term
profits
and
changes
in
long­
term
profits
due
to
a
pest
outbreak
will
be
considered.
We
will
also
consider
cases
where
control
of
a
pest
in
one
crop
avoids
damage
to
another
crop
as
part
of
an
Integrated
Pest
Management
strategy.

If
these
guidelines
are
not
relevant
to
the
applicant's
situation,
the
applicant
must
explain
why
and
provide
an
alternate
analysis,
with
supporting
documentation,
to
demonstrate
that
significant
economic
losses
are
the
result
of
the
emergency
condition.

III.
Emergency
Exemptions
for
New
Crops
Diversification
of
U.
S.
agriculture
to
improve
income
and
respond
to
new
market
opportunities
results
in
the
introduction
of
new
crops.
Because
of
their
recent
introduction,
there
are
often
few
or
no
pesticides
registered
on
these
crops.
However,
the
Section
18
process
is
not
the
appropriate
mechanism
to
obtain
a
pesticide
for
the
control
of
a
routine,
expected
pest
problem,
despite
the
lack
of
registered
alternatives.
Prior
to
introduction,
potential
pest
problems
should
be
identified
and
growers
who
undertake
production
of
a
new
crop
are
assumed
to
have
accepted
the
risks
associated
with
such
a
venture.
Only
those
situations
involving
a
pest
not
previously
known
to
affect
the
crop
or
an
abnormal
variation
in
the
population
of
a
known
pest
would
be
considered
non­
routine
by
the
Agency.

Historical
yield,
price
and
production
cost
data
are
not
usually
available
for
recently
introduced
crops
or
varieties.
The
new
tiered
approach
allows
for
more
flexibility
in
accepting
appropriate
estimates,
but
these
estimates
should
focus
on
most
likely
yields
and
prices,
rather
than
the
maximum
possible.
Page
16
of
22
Appendix
No.
1
Uses
and
States
Eligible
for
the
Streamlined
Application
Pilot
for
Repeat
Emergency
Exemption
Requests
for
2003
Use
Season.

For
the
2003
use
season,
EPA
has
identified
uses
and
states
eligible
for
the
streamlined
application
process
for
repeat
requests.
The
uses
and
states
listed
below
have
been
determined
to
meet
the
criteria
discussed
in
the
Federal
Register
Notice
and
this
guidance
document.
EPA
has
determined
that
the
states
listed
may
submit
a
streamlined
application
and
invites
them,
where
necessary,
to
certify
that
the
section
18
use
will
be
needed
to
address
an
ongoing
emergency
pest
situation
that
is
anticipated
for
the
2003
growing
season
using
the
sample
letter
in
Appendix
2
as
a
suggested
guide.

Table
1:
Uses
and
States
Eligible
for
the
Streamlined
Application
Pilot
for
"
Re­
certification"
of
Emergency
Conditions
Under
the
Section
18
Pilot
Program
for
2003.

Chemical
Site
States
bifenazate
tomato
Colorado,
Texas,
Virginia
carfentrazone
ethyl
vegetable,
fruiting
Florida
fenpyroximate
hop
Idaho
and
Washington
fludioxonil
pomegranate
California
indoxacarb
cranberry
Massachusetts
methoxyfenozide
soybean
Louisiana,
Arkansas,
Mississippi
pyriproxyfen
vegetable,
legume
Florida
tebufenozide
sweet
potato
Mississippi
tebufenozide
grass,
pasture
Vermont
and
Maine
tebufenozide
grape
Virginia
Page
17
of
22
Appendix
No.
2
Example
format
of
submission
from
the
applicant
"
re­
certifying"
the
continuation
of
an
emergency
condition
for
the
eligible
uses.

The
Xyz
State
Department
of
Agriculture
requests
a
specific
emergency
exemption
under
the
provisions
of
section
18
of
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act,
as
amended,
for
use
of
(
chemical),
formulated
as
(
product
name
(
EPA
Reg.
No.
xxx­
xx),
on
(
crop)
to
control
(
pest).
This
is
the
(#)
year
the
Xyz
State
Department
of
Agriculture
has
requested
this
use.
The
Xyz
State
Department
of
Agriculture
asks
that
this
specific
exemption
request
be
processed
as
an
expedited
repeat
request
as
the
Department
certifies
that
emergency
conditions
continue
to
exist
for
(
pest)
on
(
crop).
The
Xyz
State
Department
of
Agriculture
incorporates
by
reference
and
relies
on
the
application
previously
submitted
to
EPA
under
(
insert
ee
number)
to
support
this
exemption
request.
(
An
optional
second
certification
similar
to
the
following
can
be
added,
where
appropriate).
In
addition,
Xyz
State
Department
of
Agriculture
further
certifies
that
pesticide
applications
will
be
made
in
accordance
with,
and
incorporates
by
reference,
all
the
use
pattern
provisions
of
our
initial
specific
exemption
application
for
this
use
submitted
in
(
insert
year)
and
the
Agency's
authorization
letter
of
(
insert
date)
for
(
insert
ee
number).

Sincerely,

Designated
State
Official
Page
18
of
22
Appendix
No.
3
Example
format
for
EPA
authorization
responding
to
eligible
application
submitted
under
the
pilot
program
for
the
streamlined
application
process
for
repeat
emergency
exemption
requests.

Commissioner
Xyz
State
Department
of
Agriculture
Main
Street
City,
State
00000
Attn:
State
Contact
Fax:
(
 
)
­­­­­­­­

Date
Issued:
June
10,
2003
Date
Effective:
July
1,
2003
Expiration
Date:
September
10,
2003
Report
Due:
March
10,
2004
File
Symbol:
03­
xx­
13
Year
Number:
2nd
Year
(
4th
Year
Overall)

The
Environmental
Protection
Agency
hereby
re­
authorizes
a
specific
exemption
under
the
provisions
of
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act,
as
amended,
to
the
Xyz
State
Department
of
Agriculture
for
the
use
of
(
chemical
name),
formulated
as
(
trade
name),
on
(
commodity
name)
to
control
(
pest).
In
a
letter
dated
June
1,
2003,
the
Xyz
State
Department
of
Agriculture
re­
certified
that
the
emergency
condition
still
existed
and
that
there
were
no
changes
to
the
use
directions
as
approved
in
last
year's
authorization,
including,
but
not
limited
to,
the
use
rate,
type
of
application,
number
of
acres,
PHI,
geographical
restrictions,
etc.

Xyz
State
Department
of
Agriculture
will
ensure
that
pesticide
applications
will
be
made
in
accordance
with
all
of
the
provisions
of
the
specific
exemption
application
submitted
in
(
insert
year)
and
the
Agency's
authorization
letter
of
(
insert
date)
for
(
insert
ee
number).
It
is
also
responsible
for
providing
information
in
accordance
with
40
C.
F.
R.
166.32.
This
information
must
be
submitted
to
EPA
headquarters
and
the
EPA
regional
office.
The
EPA
shall
immediately
be
informed
of
any
adverse
effects
resulting
from
the
use
of
this
pesticide
in
connection
with
this
exemption.

This
is
the
second
year
that
the
Agency
has
issued
this
exemption
to
the
Xyz
State
Department
of
Agriculture
and
the
first
year
it
has
been
re­
authorized.
The
Xyz
State
Department
of
Agriculture
will
be
allowed
to
re­
certify
this
exemption
for
one
additional
year
after
which
a
full
application
must
be
submitted
to
the
Agency
for
comprehensive
review.

Director,
Registration
Division,

Date:

Appendix
No.
4
Page
19
of
22
Conventional
Pesticide
Active
Ingredients
Eligible
for
the
Section
18
Pilot
Initiative
Concerning
an
Alternative
Means
for
Establishing
"
Significant
Economic
Loss"

Reduced
Risk
Ingredients
acetamiprid
alpha­
metolachlor
azoxystrobin
bifenazate
buprofezin
carfentrazone­
ethyl
cyhalofop­
butyl
cyprodinil
diflubenzuron
diflufenzopyr
s­
dimethenamid
Ecolyst
fenamidone
fenhexamid
fenpyroximate
fluazinam
flucarbazone­
sodium
fludioxonil
flumiclorac­
pentyl
glyphosate
hexaflumuron
hymexazol
imazamox
imazapic
imazethapyr
indoxacarb
lambda­
cyhalothrin
macalayea
extract
mefenoxam
mesotrione
methoxyfenozide
methyl
anthranilate
novaluron
prohexadione­
calcium
pymetrozine
pyriproxyfen
spinosad
tebufenozide
trifloxystrobin
zoxamide
***
EPA
will
continue
to
apply
appropriate
regulatory
and
statutory
standards
to
any
emergency
exemption
request
involving
these
chemicals.
Appendix
4.
continued
Page
20
of
22
Biological,
Microbial
and
Other
Ingredients
Eligible
for
the
Section
18
Pilot
Initiative
Concerning
an
Alternative
Means
for
Establishing
"
Significant
Economic
Loss"

Floral
Attractants/
plant
Volatiles
Anise,
oil
of
Mustard,
oil
of
Citronella,
oil
of
yr
in
question
Indole
Lavandin
oil
Jasmine,
oil
of
Lemon
grass,
oil
of
Eucalyptus,
oil
of
Cinnamaldehyde
1,2,4­
Trimethoxybenzene
3­
Phenyl­
2­
propenol
Orange,
oil
of
(
Z)
cis­
1­
octen­
3­
ol
2­
Phenylethyl
propionate
(
Nuranone)
Eugenol
Bergamont,
Oil
of
Geraniol
2­
Cyclopenten­
1­
one,
2­
hydroxy­
3­
methyl
(
maple
lactone)

Plant
Growth
Regulators
and
Herbicides
Ethylene
Gibberellic
acid
Gibberellic
Acid,
monopotassium
salt
Acetic
Acid
Indole­
3­
butyric
Acid
1,4
Dimethyl­
napthalene
Kinetin
(
N6
furfuryladenine)
Cytokinin
N6­
Benzyladenine
Gibberellin
A4
Mixt
with
Gibberellin
A7
Chitosan
Sodium
5­
nitroguaiacolate
Sodium
o­
nitrophenolate
Sodium
p­
nitrophenolate
Aminoethoxyvinylglycine
Pelargonic
acid
1­
methylcyclopropene
Lactic
acid
Lysophosphatidyl­
ethanolamine
Corn
Glutten
Meal
Natural
Insect
Growth
Regulators
Isopropyl
(
2E,
4E)­
11methoxy­
3,7,11­
trimethyl­
2­
4
dodecadienoate
Isopropyl
(
2E,
4E,
7S­
11­
methoxy­
3,7,11­
trimethyl­
2­
4­
dodecadienoate
2­
Propynyl
(
S­(
E,
E))­
3,7­
1trimethyl­
2,4­
dodecadiene
Azadirachtin
Ethyl
(
2E,
4E,
7S)­
trimethyl­
2,4­
dodecadienoate
Pheromones
Lauryl
alcohol
Myristyl
alcohol
(
E,
E)­
8,10­
Dodecadien­
1­
o1
German
cockroach
Pheromone
(
E)­
5­
Decenol
(
E)­
5­
Decenol
Acetate
(
Z,
Z)­
3,13­
Octadecadien­
1­
o1
acetate
(
E,
Z)­
3,13­
Octadecadien­
1­
o1
acetate
(
1R­
cis)­
1­
methyl­
2­(
1­
methylethenyl)
cyclobutaneethanol
(
Z)­
2­(
3,3­
Dimethylcyclohexylidene)
ethanol
(
E)­(
3,3­
Dimethylcyclohexylidene)
acetaldehyde
(
Z)­(
3,3­
Dimethylcyclohexylidene)
acetaldehyde
(
Z,
E)­
7,11­
Hexadecadien­
10yl
acetate
(
Z,
Z)­
7,11­
Hexadecadien­
10yl
acetate
7,11­
Hexadecadienol­
1­
ol,
acetates
cis­
7,8­
Epoxy­
2­
methyloctadecane
(
R,
Z)­
5­(
1­
Decenyl)
dihydro­
2(
3H)­
Furanone
(
Z)­
11­
Hexadecenal
(
Z)­
4­
Tridecen­
1­
y1
acetate
(
E)­
4­
Tridecen­
1­
y1
acetate
(
Z)­
8­
Dodecen­
1­
yl
acetate
(
E)­
8­
Dodecen­
1­
yl
acetate
(
Z)­
8­
Dodecen­
1­
ol
3,7,11­
Trimethyl­
2,6,10­
dodecatriene­
1­
o1
3,7,11­
Trimethyl­
1,6,10­
dodecatriene­
3­
o1
(
Z)­
11­
Tetradecenyl
acetate
(
Z)­
9­
Dodecenyl
acetate
(
E)­
11­
Tetradecen­
1­
o1,
acetate
(
E)­
11­
Tetradecen­
1­
o1
(
Z)­
11­
Tetradecenyl
acetate
(
E)­
11­
Tetradecen­
1­
o1,
acetate
(
Z)­
11­
Tetradecenyl
acetate
(
Z)­
9­
Tricosene
(
E)­
9­
Tricosene
(
Z)­
9­
dodecenyl
acetate
3­
methyl­
2­
cyclohex­
1­
one
(
MCH)
Z­
9­
Tetradecen­
1­
ol
Appendix
4.
continued
Page
21
of
22
Z,
E,
9,12­
Tetradecadien­
1­
yl
Verbenone
(
zz)­
11,13­
Hexadecedienol
4­(
or5­)
Chloro­
2­
methylcyclohexanecarboxylic
acid,
1,1­
dimethyl
ester
(
Z)­
11­
Hexdecenyl
Acetate
(
E)­
9­
Dodecen­
1­
ol
acetate
Repellents
Dried
blood
Capsaicin
Red
Pepper
Methyl
Salicylate
Meat
Meal
Putrescent
whole
egg
solids
Methyl
anthranilate
Allium
sativum
(
Garlic
oil)
Linalool
Fish
oil
Cederwood
oil
Iron
phosphate
.
beta.­
Alanine,
N­
acetyl­
N­
butyl­,
ethyl
estor
(
IR
3535)
p­
methane­
3,8­
diol
Mint
Oil
Thyme
(
herb)

Miscellaneous
biochemicals
Neem
oil
Clarified
hydrophobic
neem
oil
Soybean
oil
Castor
oil
Jojoba
Oil
Sodium
bicarbonate
Potassium
bicarbonate
Sodium
lauryl
sulfate
RED
multi
divisional
Liquid
Nitrogen
Ground
sesame
stalks
Poly­
N­
acetyl­
D­
glucosamine
Polyoxin
D
znc
salt
Kaolin
Canola
Oil
Monobasic
potassium
phosphate
Formic
acid
Hydrogen
peroxide
Harpin
Protein
Phosphorous
Acid
Reynoutria
sachalinensis
(
Milsana)
4­
allyl
anisole
Dipostassium
phosphate
Sucrose
octanoate
Registered
Microbial
Pesticides
Bacteria
Spores
of
Bacillus
popilliae
Bacillus
thuringiensis
subsp.
kurstaki
Agrobacterium
radiobacter
K84
B.
thuringiensis
subsp.
israelensis
B.
thuringiensis
.
Berliner
B.
thuringiensis
subsp.
tenebrionis
P.
fluorescens
A506
P.
fluorescens
1629RS
P.
syringae
742RS
B.
thuringiensis
subsp.
kurstaki
EG2348
B.
thuringiensis
subsp.
kurstaki
EG2424
B.
thuringiensis
subsp.
kurstaki
EG2371
B.
sphaericus
B.
subtilis
GBO3
B.
thuringiensis
subsp.
aizawai
GC­
91
B.
thuringiensis
subsp.
aizawai
Streptomyces
griseoviridis
K61
B.
thuringiensis
subsp.
kurstakiBMP123
B.
subtilis
MBI
600
P.
syringae
ESC
10
P.
syringae
ESC
11
B.
thuringiensis
subsp
kurstaki
EG7841
B.
thuringiensis
subsp
kurstaki
EG7826
B.
thuringiensis
subsp
kurstaki
M200
B.
thuringiensis
subsp
kurstaki
EG7673
col.
toxin
Bacillus
cereus
Strain
BP01
Paecilomyces
fumorsoroseus
Apopka
strain
97
B.
thuringiensis
subsp
isaelensis
st
g2215
Pseudomanas
aureofaciens
st
Tx­
1
B.
subtilis
amyloliquefacie
ns
strain
fzb24
Bacillus
subtilis
qst
713
Pseudomonas
chlororaphis
St
63­
28
Yeast
Candida
oleophila
I­
182
Fungi
Phytophthora
palmivora
MWV
Colletotrichum
gloeosporioides
f.
sp.
aeschynomene
ATCC
20358
f.
sp.
aeschynomene
ATCC
20358
Appendix
4.
continued
Page
22
of
22
Trichoderma
harzianum
ATCC
20476
Trichoderma
polysporum
ATCC
20475
Gliocladium
virens
G­
21
Trichoderma
harzianum
Rifai
KRL­
AG2
Lagenidium
giganteum
Metarhizium
anisopliae
ESF1
Ampelomyces
quisqualis
M10
Beauveria
bassiana
GHA
Beauveria
bassiana
ATCC
74040
Gliocladium
catenulatum
Strain
J1446
Trichoderma
Harzianum
Strain
T­
39
Coniothyrium
minitans
St
con/
m/
91­
08
Killed
fermentation
solids
&
solubles
of
Myrothecium
verrucaria
Myrothecium
verrucaria
Beauveria
bassiana
st
447
Pseudozyma
flocculosa
Protozoa
Nosema
locustae
Viruses
Heliothis
Nucleopolyhedrosis
virus
(
NPV)
Douglas
fir
tussock
moth
NPV
Gypsy
moth
NPV
Beet
armyworm
NPV
Cydia
pomonella
Granulosis
virus
Indian
Meal
Moth
Granulosis
Virus
Anagrapha
falcifera
NPV
(
Celery
Looper
Virus)

Non­
viable
Microbial
Pesticides­­(
Engineered)

Bt
subsp.
kurstaki
delta­
endotoxin
in
K
P.
fluorscens
in
killed
P.
fluorescens
Bt
subsp.
san
diego
delta­
endotoxin
in
K
P.
fluorescens
in
killed
P.
fluorescens
Bt
CryIA(
c)
&
Cry
I(
c)
delta­
endotoxin
in
K
P
fluorescens
in
killed
P.
fluorescens
Bt
K
CryIC
in
killed
pseudononus
Agrobacterium
radiobacter
Strain
K1026