20145
Federal
Register
/
Vol.
68,
No.
79
/
Thursday,
April
24,
2003
/
Notices
potential
agenda
topics
that
your
tribe
would
like
to
see
addressed
at
the
conference.
EPA
will
forward
all
suggestions
to
the
selected
tribal
host.
EPA
also
encourages
you
to
attend
the
conference
regardless
of
whether
you
are
interested
in
hosting
the
event.

List
of
Subjects
Environmental
protection,
Indian
tribes.

Dated:
April
16,
2003.
Stephen
L.
Johnson,
Assistant
Administrator,
Office
of
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
03
 
10168
Filed
4
 
23
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0231;
FRL
 
7293
 
6]

RIN
2070
 
AD36
Pesticides;
Emergency
Exemption
Process
Revisions
Pilot
and
Request
for
Comment
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
Section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizes
EPA
to
issue
emergency
exemptions
to
States
and
Federal
agencies,
allowing
them
to
use
a
pesticide
for
an
unregistered
use
for
a
limited
time
if
EPA
determines
that
emergency
conditions
exist.
EPA
is
announcing
and
seeking
comment
on
a
limited
pilot
program
initiated
by
this
Notice.
The
pilot
is
limited
to
exemption
applications
for
which
the
requested
chemical
is
a
pesticide
previously
identified
by
EPA
as
a
reduced­
risk
pesticide.
Under
this
limited
pilot,
EPA
will
allow
applicants
for
certain
exemptions
to
re­
certify
that
the
emergency
conditions
which
initially
qualified
for
an
exemption
continue
to
exist
in
the
second
and
third
years,
and
will
allow
for
a
new
tiered
approach
to
be
used
for
documenting
a
``
significant
economic
loss.''
This
limited
pilot
is
the
result
of
extensive
stakeholder
involvement
and
an
effort
to
streamline
the
emergency
exemption
process.
EPA
is
also
seeking
comment
on
another
potential
improvement
to
the
emergency
exemption
program
that
would
provide
exemptions
for
certain
pest
resistance
management
purposes.
EPA
is
considering
these
improvements
to
the
emergency
exemption
program
in
an
effort
to
reduce
the
burden
to
both
applicants
and
EPA,
allow
for
quicker
decisions
by
the
Agency,
and
facilitate
resistance
management,
while
maintaining
health
and
safety
requirements.
EPA
currently
intends
to
publish
a
proposed
rule
in
2003
that
will
propose
several
potential
improvements
to
the
emergency
exemption
regulations.
EPA
will
consider
any
available
information
from
this
pilot
as
it
proceeds
with
rulemaking.
DATES:
Comments,
identified
by
the
Docket
ID
No.
OPP
 
2002
 
0231,
must
be
received
on
or
before
June
23,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
section.
FOR
FURTHER
INFORMATION
CONTACT:
Joseph
Hogue,
Field
and
External
Affairs
Division
(
7506C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
703
 
308
 
9072;
fax
number:
703
 
305
 
5884;
e­
mail
address:
hogue.
joe@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
a
Federal,
State,
or
Territorial
government
agency
that
petitions
EPA
for
section
18
use
authorization.
Regulated
categories
and
entities
may
include,
but
are
not
limited
to:
 
Federal
Government
(
NAICS
Code
9241),
i.
e.,
Federal
agencies
that
petition
EPA
for
section
18
use
authorization.
 
State
or
Territorial
governments
(
NAICS
Code
9241),
i.
e.,
States,
as
defined
in
FIFRA
section
2(
aa),
that
petition
EPA
for
section
18
use
authorization.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
above
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
summary
of
the
applicability
provisions
as
found
in
Unit
III.
B.
of
this
Notice.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
in
the
FOR
FURTHER
INFORMATION
CONTACT
section.
B.
How
Can
I
Get
Copies
of
this
Notice
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
Docket
ID
No.
OPP
 
2002
 
0231.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
This
Docket
Facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
Docket
telephone
number
is
703
 
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
Notice
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
identification
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
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24APN1.
SGM
24APN1
20146
Federal
Register
/
Vol.
68,
No.
79
/
Thursday,
April
24,
2003
/
Notices
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
Docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
identification
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
below,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e­
mail
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
Docket
ID
No.
OPP
 
2002
 
0231.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
electronic
mail
(
e­
mail)
to
oppdocket
epa.
gov,
Attention
Docket
ID
No.
OPP
 
2002
 
0231.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
email
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
Docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Mail
Code:
7502C,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
Attention
Docket
ID
No.
OPP
 
2002
 
0231.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA,
Attention
Docket
ID
No.
OPP
 
2002
 
0231.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
identified
in
the
FOR
FURTHER
INFORMATION
CONTACT
section.

II.
Purpose
of
this
Notice
This
Notice
announces
the
implementation
of
and
seeks
public
comment
on
a
limited
pilot
starting
with
the
2003
growing
season.
The
pilot
involves
two
potential
process
improvements
to
the
emergency
exemption
program
that
are
the
result
of
an
effort
to
streamline
the
emergency
exemption
process.
EPA
is
taking
this
action
after
extensive
stakeholder
involvement
(
see
Unit
IV.).
The
pilot
is
limited
to
exemption
applications
for
which
the
requested
chemical
is
a
pesticide
previously
identified
by
EPA
as
a
reduced­
risk
pesticide.
Under
the
limited
pilot,
EPA
will
allow
applicants
for
certain
exemptions
to
re­
certify
(
and
incorporate
a
previous
application's
information
by
reference)
that
the
emergency
conditions
which
initially
qualified
for
an
exemption
continue
to
exist
in
the
second
and
third
years,
and
will
allow
for
a
new
tiered
approach
to
be
used
for
documenting
a
``
significant
economic
loss.''
EPA
is
also
seeking
VerDate
Jan<
31>
2003
18:
45
Apr
23,
2003
Jkt
200001
PO
00000
Frm
00037
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
24APN1.
SGM
24APN1
20147
Federal
Register
/
Vol.
68,
No.
79
/
Thursday,
April
24,
2003
/
Notices
comment
on
another
potential
change
being
considered
for
the
emergency
exemption
program,
i.
e.,
whether
to
allow
exemptions
for
pest
resistance
management
purposes.
EPA
is
considering
these
improvements
to
the
emergency
exemption
program
regulations
in
40
CFR
part
166
in
an
effort
to
reduce
the
burden
to
both
applicants
and
EPA,
allow
for
quicker
decisions
by
the
Agency,
and
facilitate
pest
resistance
management,
while
maintaining
health
and
safety
requirements.
EPA
currently
intends
to
publish
a
proposed
rule
in
2003
that
will
propose
several
potential
improvements
to
the
emergency
exemption
regulations.
EPA
will
consider
any
available
information
from
this
pilot
as
it
proceeds
with
rulemaking.
The
potential
revisions
to
the
emergency
exemption
process
described
in
this
Notice
arose
from
an
effort
to
evaluate
the
emergency
exemption
regulations
at
40
CFR
part
166,
begun
in
1995.
As
part
of
that
effort,
in
November
1996,
the
Agency
hosted
a
Section
18
Stakeholders
Workshop
to
discuss
possible
improvements
to
the
Agency's
emergency
exemption
process
and
receive
stakeholder
input.
The
improvements
discussed
at
the
workshop,
and
those
included
in
this
Notice,
directly
affect
only
applicants
for
emergency
exemptions.
States
are
the
primary
applicants
for
emergency
exemptions,
although
Federal
agencies
may
also
apply.
Recommendations
from
the
Association
of
American
Pest
Control
Officials
(
AAPCO)
Section
18
Task
Force,
representing
the
States,
are
the
general
basis
for
EPA's
plan
announced
by
this
Notice.
AAPCO
originally
provided
EPA
with
recommendations
following
the
1996
workshop
and
recently
submitted
a
revised,
shortened
list
of
three
recommendations.
This
Notice
begins
to
address
those
three
recommendations.
EPA
has
carefully
refined
each
recommendation
in
an
effort
to
address
concerns
expressed
by
other
stakeholders.
In
refining
those
recommendations,
the
Agency
attempted
to
maximize
the
streamlining
benefits
while
making
sure
it
can
still
carry
out
its
health
and
safety
responsibilities.
A
discussion
of
the
evaluation
process
leading
up
to
this
Notice,
including
stakeholder
input
and
recommendations,
is
in
Unit
IV.
After
receiving
comment
on
this
Notice
or
near
the
end
of
the
first
year
under
the
pilot,
EPA
plans
to
again
consult
the
Pesticide
Program
Dialogue
Committee
(
PPDC)
on
the
potential
improvements
discussed
in
this
Notice.
At
that
time,
the
Agency,
applicants
for
emergency
exemptions,
and
many
others
will
be
able
to
share
and
discuss
their
experiences
concerning
the
pilot
provisions.
The
diverse
group
of
stakeholders
represented
at
PPDC
meetings
provides
an
excellent
source
of
feedback
to
the
Agency.
Input
from
the
PPDC
will
be
carefully
considered,
along
with
public
comments
received
in
response
to
this
Notice,
public
comments
on
the
proposed
rule
expected
in
2003,
and
experience
from
the
pilot,
when
deciding
what
will
be
included
in
the
final
rule.
The
following
is
a
summary
of
the
statutory
and
regulatory
framework
of
the
Emergency
Exemption
Program,
a
description
of
the
extensive
stakeholder
involvement
that
forms
the
basis
for
the
limited
pilot
and
this
request
for
comment,
a
detailed
description
of
the
limited
pilot,
and
the
Agency's
request
for
comment.

III.
Existing
Statutory
and
Regulatory
Framework
A.
Statutory
Provisions­­
FIFRA
Section
18
Section
18
of
FIFRA
gives
the
Administrator
of
EPA
broad
authority
to
exempt
any
Federal
or
State
agency
from
any
provision
of
FIFRA
if
the
Administrator
determines
that
emergency
conditions
exist
which
require
such
exemption.

B.
Regulatory
Provisions­­
40
CFR
Part
166
Regulations
governing
such
FIFRA
section
18
emergency
exemptions
are
codified
in
40
CFR
part
166.
Generally,
these
regulations
allow
a
Federal
or
State
agency
to
apply
for
an
exemption
to
allow
a
use
of
a
pesticide
that
is
not
registered
when
such
use
is
necessary
to
alleviate
an
emergency
condition.
A
State,
as
defined
by
FIFRA
section
2(
aa),
means
a
State,
the
District
of
Columbia,
the
Commonwealth
of
Puerto
Rico,
the
Virgin
Islands,
Guam,
the
Trust
Territory
of
the
Pacific
Islands
and
American
Samoa.
The
regulations
set
forth
information
requirements,
procedures,
and
standards
for
EPA's
approval
or
denial
of
such
exemptions.
Federal
and
State
agencies
may
apply
to
EPA
for
a
section
18
emergency
exemption
from
FIFRA
due
to
a
public
health
emergency,
a
quarantine
emergency,
or
a
``
specific''
emergency.
Most
exemptions
from
FIFRA
requested
or
granted
under
section
18
fall
under
the
category
of
``
specific
exemptions.''
Typical
justifications
for
specific
exemptions
include,
but
are
not
limited
to,
the
expansion
of
the
range
of
a
pest;
the
cancellation
or
removal
from
the
market
of
a
previously
registered
and
effective
pesticide
product;
and
the
development
of
resistance
in
pests
to
a
registered
product,
or
loss
of
efficacy
of
available
products
for
any
reason.
Additionally,
an
emergency
situation
is
generally
considered
to
exist
when
no
other
viable
(
chemical
or
non­
chemical)
means
of
control
exist,
and
where
the
emergency
situation
will
cause
significant
economic
losses
to
affected
individuals
if
the
exemption
is
not
granted.
When
a
Federal
or
State
agency
applies
to
EPA
under
section
18,
it
must
submit
a
request
in
writing
that
documents
the
emergency
situation,
the
pesticide
proposed
for
the
use,
the
target
pest,
the
crop,
the
rate
and
number
of
applications
to
be
made,
the
geographical
region
where
the
pesticide
would
be
applied,
and
a
discussion
of
risks
which
may
be
posed
to
human
health
or
to
the
environment
as
a
result
of
the
pesticide
use
(
40
CFR
166.20).
EPA
conducts
an
expedited
review
of
the
request,
verifying
the
existence
of
the
emergency,
assessing
risks
posed
to
human
health
through
food,
drinking
water,
and
residential
exposure,
assessing
risks
posed
to
farmworkers
and
other
handlers
of
the
pesticide,
assessing
any
adverse
effects
on
nontarget
organisms
(
including
Federally
listed
endangered
species),
and
assessing
the
potential
for
contamination
of
ground
water
and
surface
water.
If
an
application
for
the
requested
use
has
been
made
in
previous
years,
EPA
does
an
assessment
of
the
progress
toward
registration
for
the
use
of
the
requested
chemical
on
the
requested
crop,
and
considers
this
status
in
the
final
determination
to
grant
or
deny
the
exemption.
If
EPA
concludes
that
the
situation
is
an
emergency,
and
that
the
use
of
the
pesticide
under
the
exemption
will
be
consistent
with
the
standards
of
the
Food
Quality
Protection
Act
(
FQPA)
and
40
CFR
part
166,
then
EPA
may
authorize
the
pesticide
to
be
used
under
section
18.
Section
18
pesticide
uses
for
specific
and
public
health
exemptions
can
be
authorized
for
periods
not
to
exceed
1
year;
uses
under
quarantine
exemptions
can
be
authorized
for
up
to
3
years.
Since
actions
taken
under
section
18
are
intended
to
address
a
time­
specific
crisis
or
emergency
need
for
temporary
relief,
most
section
18
exemptions
are
specific
exemptions
which
are
granted
for
just
one
growing
season.
Such
actions
should
not,
therefore,
be
viewed
as
an
alternative
to
registering
the
use(
s)
needed
for
longer
periods.
If
the
situation
addressed
with
the
section
18
exemption
persists,
or
is
expected
to
persist,
affected
entities
must
take
the
proper
steps
to
amend
the
existing
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registration
or
seek
a
new
registration
to
address
that
future
need.

IV.
Background
and
Summary
of
Stakeholder
Feedback
A.
1996
Section
18
Workshop
to
Streamline
Emergency
Exemption
Process
In
1995,
as
part
of
an
effort
to
streamline
regulations,
the
Agency
began
a
process
to
evaluate
the
emergency
exemption
regulations
at
40
CFR
part
166,
and
to
formulate
recommended
changes
to
the
operating
procedures.
As
part
of
that
effort,
in
November
1996,
the
Agency
hosted
a
Section
18
Stakeholders
Workshop
to
discuss
possible
regulatory
changes
to
the
Agency's
section
18
process
and
receive
stakeholder
input.
Participants
of
that
meeting
included
representatives
from
State
agencies
responsible
for
pesticide
oversight,
chemical
companies,
and
environmental
and
public
interest
groups.
Participants
voiced
their
concerns
and
identified
suggestions
for
improving
the
emergency
exemption
process.
Although
EPA
scheduled
the
section
18
workshop
prior
to
passage
of
the
FQPA,
in
August
1996,
the
workshop
was
held
shortly
after
the
law
was
enacted.
Because
FQPA
included
new
requirements
affecting
emergency
exemptions,
and
was
just
3
months
old
at
the
time
of
the
workshop,
the
new
law
was
of
great
interest
to
participants.
Stakeholders
at
the
workshop
were
deeply
concerned
that
the
new
requirements
of
FQPA
would
hurt
both
the
Agency's
review
time
and
approval
rate
for
exemption
requests,
as
well
as
increase
the
burden
on
applicants
(
primarily
States)
for
information
and
documentation.
Several
of
the
recommendations
raised
in
the
workshop
addressed
these
three
concerns.

B.
NASDA/
AAPCO
Initial
Recommendations
to
EPA
for
Improvements
Subsequent
to
the
November
1996
Section
18
Stakeholders
Workshop,
the
National
Association
of
State
Departments
of
Agriculture
(
NASDA)
and
the
Association
of
American
Pest
Control
Officials
(
AAPCO)
jointly
sent
a
letter
to
EPA
to
provide
recommendations
for
changes
to
the
emergency
exemption
process.
The
letter
referred
to
recommendations
contained
in
a
series
of
NASDA
Proposed
Resolutions.
A
copy
of
that
letter
and
the
Proposed
Resolutions
are
available
in
the
public
docket
for
this
Notice.
The
NASDA/
AAPCO
recommendations,
which
generally
summarized
issues
raised
at
the
workshop,
were:
1.
Seek
changes
to
current
regulations
which
will
allow
EPA
the
flexibility
to
base
decisions
on
crop
yield
as
opposed
to
crop
value
(
or
profit
loss)
in
situations
where
that
is
a
better
indicator
of
pest
damage.
2.
Provide
States
general
guidance
regarding
the
appropriate
documentation
of
an
``
urgent,
nonroutine
situation''
and
allow
States
to
certify
that
the
``
urgent,
non­
routine
situation''
exists
based
on
the
guidance.
3.
Implement
a
performance
audit
program
to
ensure
compliance
with
the
guidance
and
give
States
justification
to
resist
pressure
to
certify
an
``
urgent,
non­
routine
situation''
when
it
does
not
exist.
4.
Delegate
to
the
States
authority
to
reissue
the
section
18
exemption
for
a
second
or
third
year,
based
on
the
State's
confirmation/
certification
that
the
basis
for
an
emergency
continues
to
exist.
5.
Actively
support
and
coordinate
regional
section
18
requests.
6.
Enter
into
discussions
with
the
States
to
establish
reasonable
monitoring
criteria
and
approaches
for
wildlife
and
endangered
species.
7.
Support
specific
exemptions
for
resistance
management
where
there
is
documented
scientific
evidence
of
resistance
to
currently
registered
pesticides
or
where
valid
research
demonstrates
that
a
dynamic
process
of
resistance
is
developing.
8.
Amend
40
CFR
166.2
to
include
``
reduced
risk''
as
an
acceptable
basis
for
granting
a
section
18
exemption.
The
definition
of
``
reduced
risk,''
and
the
requirements
for
this
request
should
allow
States
the
ability
to
request
a
section
18
to
allow
for
a
pesticide
use
that
will
result
in
a
lower
potential
for
an
adverse
impact
on
human
health
or
any
other
non­
target
species,
including
but
not
limited
to,
pest
predators,
pollinators,
endangered
species,
and
other
organisms
of
special
concern.
Requests
should
be
limited
to
only
those
situations
where
the
``
reduced
risk''
request
will
not
result
in
additional
risk
to
any
aspect
of
the
environment.
Such
requests
should
only
be
permitted
where
the
proposed
use
is
highly
effective
so
that
the
potential
for
an
increase
in
pesticide
applications
is
extremely
low.
The
NASDA
Proposed
Resolutions
also
included
recommendations
concerning
the
establishment
of
timelimited
tolerances
for
residues
in
food
of
pesticides
used
under
emergency
exemptions.
Tolerances
for
pesticide
uses
under
section
18
have
already
been
addressed
separately
by
EPA,
as
FQPA
required
that
the
Agency
publish
a
regulation
to
put
in
place
a
process
for
that
purpose.
Therefore,
the
NASDA/
AAPCO
recommendations
concerning
tolerances
are
not
included
in
this
discussion.

C.
The
Food
Quality
Protection
Act
and
Evolution
of
the
Emergency
Exemption
Program
FQPA
included
new
requirements
affecting
emergency
exemptions,
as
stated
above.
FQPA
set
a
new
safety
standard,
and,
for
the
first
time
required
time­
limited
tolerances
for
pesticide
residues
in
food
resulting
from
pesticide
use
under
emergency
exemptions.
As
a
result
of
FQPA,
each
emergency
exemption
request
must
be
evaluated
based
on
the
potential
risk
to
human
health
and
the
environment,
including
the
aggregate
risk
to
the
public
from
ingestion
of
treated
food,
pesticide
residues
in
drinking
water,
and
exposure
to
the
pesticide
in
and
around
the
home
and
other
non­
occupational
settings.
Processing
time
for
emergency
exemption
requests
(
days
from
receipt
of
request
to
decision)
increased
significantly
in
1997,
the
first
year
after
FQPA,
as
EPA
developed
methodology
to
implement
section
18
under
the
new
law.
Due
to
the
urgent
nature
of
emergency
exemption
requests,
the
Agency
worked
very
hard
to
streamline
the
process.
Average
processing
time
decreased
to
pre­
FQPA
rates
in
1998,
and
has
decreased
each
year
since
then.
The
average
processing
time
for
exemption
requests
reached
an
all­
time
low
of
44
days
in
2000,
for
the
first
time
surpassing
the
Agency's
goal
of
50
days,
and
decreased
again
to
34
days
in
2001.
The
approval
rate
for
exemption
requests
is
similar
to
pre­
FQPA
levels.
The
number
of
exemption
requests
has
increased
sharply
since
1996,
as
have
the
number
of
exemptions
granted.
EPA
believes
the
burden
on
applicants
to
request
any
individual
emergency
exemption
has
not
increased
since
the
recommendations
were
made,
and
in
some
cases
it
has
decreased.
The
Agency
has
worked
hard
to
be
flexible
with
applicants,
to
make
full
use
of
existing
data,
and
to
minimize
documentation
requirements
where
appropriate,
with
particular
attention
to
issues
raised
in
the
NASDA/
AAPCO
recommendations.
Although
FQPA
did
not
appreciably
increase
applicant
burden
in
preparing
any
specific
emergency
exemption
request,
the
Agency
is
always
interested
in
improving
and
streamlining
its
processes.

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D.
Stakeholder
Feedback
and
EPA
Response
Since
Workshop
and
Initial
Recommendations
Since
the
Section
18
Stakeholders
Workshop
in
1996
and
receipt
of
the
NASDA/
AAPCO
recommendations,
EPA
has
worked
closely
with
stakeholders
to
develop
the
best
approach
to
address
the
recommendations.
Adoption
of
any
of
the
recommendations
would
primarily
affect
applicants
for
emergency
exemptions.
Because
only
States,
U.
S.
territories,
and
Federal
agencies
can
apply
for
emergency
exemptions,
EPA
has
had
the
rare
opportunity
to
work
very
closely
with
a
large
percentage
of
the
parties
affected
by
a
procedural
change
to
gain
valuable,
ongoing
feedback
during
the
effort
to
develop
the
potential
improvements
discussed
in
this
Notice.
After
the
initial
NASDA/
AAPCO
recommendations
were
submitted,
a
workgroup
consisting
of
EPA
staff
and
several
representatives
of
State
agencies
responsible
for
pesticide
oversight
met
regularly
to
develop
specific
options
to
address
each
of
the
recommendations.
During
this
time
and
subsequently,
the
Agency
looked
for
ways
to
improve
the
process
and
further
expedite
decisions
on
requests.
EPA
reviewed
the
NASDA/
AAPCO
recommendations,
and
the
options
developed
by
the
workgroup,
to
determine
what
could
be
accomplished
through
non­
regulatory
internal
process
improvements.
These
efforts
paid
off
in
repeatedly
shortened
average
review
times
for
emergency
exemption
requests.
Due
to
the
significant
improvements
in
the
emergency
exemption
process
and
program
during
the
several
years
following
the
original
NASDA/
AAPCO
recommendations,
the
needs
of
the
States
changed.
The
AAPCO
Section
18
Task
Force
has
reviewed
the
past
set
of
recommendations
and
recently
provided
updated,
final
State
recommendations
for
improving
the
emergency
exemption
program
(
see
Unit
IV.
E.).
Each
of
the
original
eight
recommendations
has
either
been
intentionally
excluded
by
AAPCO
in
their
final
three
recommendations,
or
is
being
addressed
in
this
Notice.
AAPCO's
letter
with
the
final
recommendations
acknowledged
that,
based
on
several
years
of
experience
with
the
section
18
process
under
FQPA,
they
no
longer
suggested
that
EPA
pursue
the
other
initial
recommendations.
The
initial
recommendations
numbered
1,
4,
and
7
(
see
Unit
IV.
B.)
are
addressed
in
this
Notice.
The
second
and
third
of
the
initial
recommendations
were
designed
to
be
implemented
together,
and
were
essentially
another
option
for
the
fourth,
which
AAPCO
ultimately
favored.
EPA
does
encourage
and
help
to
coordinate
regional
emergency
exemption
requests
involving
multiple
States,
which
was
the
fifth
recommendation.
Concerning
recommendation
number
six,
EPA
is
continuing
to
work
with
States
to
develop
monitoring
criteria
for
wildlife
and
endangered
species
in
the
context
of
pesticide
registration.
While
the
eighth
recommendation,
to
allow
exemptions
based
on
reduced
risk,
has
not
been
adopted,
EPA
does
take
reduced
risk
benefits
into
account
as
a
factor
in
decisions.
EPA
also
solicited
public
comments
on
the
original
NASDA/
AAPCO
recommendations
to
improve
the
emergency
exemption
process,
in
the
preamble
to
the
proposed
rule
titled
``
Tolerances
for
Pesticide
Emergency
Exemptions''
(
64
FR
29823,
June
3,
1999)
(
FRL
 
5750
 
1).
The
Agency
only
received
comments
on
the
listed
recommendations
from
four
parties.
Two
of
the
commenters
were
State
departments
of
agriculture.
Both
States
generally
agreed
with
all
the
recommendations,
but
in
particular
supported
the
three
revisions
addressed
in
this
Notice.
One
State
offered
refinements
to
several
of
the
recommendations.
The
other
two
commenters
were
public
interest
groups.
Both
groups
opposed
all
of
the
recommendations.
However,
EPA
believes
that
the
operational
revisions
to
the
process
being
piloted
have
been
refined
in
such
a
way
as
to
address
most
of
the
concerns
stated
in
their
comments.
One
group
noted
that
the
current
emergency
exemption
regulations
are
the
result
of
negotiated
rulemaking,
a
process
which
included
a
balanced
representation
of
interests,
but
that
the
Section
18
Stakeholders
Workshop,
which
culminated
in
the
NASDA/
AAPCO
recommendations
was
not
an
adequately
open
process.
EPA
believes
the
workshop
included
participants
from
a
wide
array
of
interests,
as
representatives
from
State
agencies
responsible
for
pesticide
oversight,
chemical
companies,
and
environmental
and
public
interest
groups
attended.
Also,
the
Agency's
plan
to
undertake
notice­
and­
comment
rulemaking
procedures
before
adopting
any
final
changes
to
the
section
18
process
will
again
allow
all
interested
parties
to
participate
in
the
development
of
the
potential
changes.
In
May
2002,
EPA
presented
its
general
plan
concerning
the
three
revisions
to
the
emergency
exemption
process
included
in
this
Notice
to
the
PPDC.
The
PPDC
provides
a
forum
for
a
diverse
group
of
stakeholders
to
provide
feedback
to
EPA
on
various
pesticide
regulatory,
policy,
and
program
implementation
issues.
A
wide
array
of
stakeholders
provided
comments
at
the
May
meeting,
which
EPA
has
considered
in
refining
the
pilot
and
proposed
revisions
in
this
Notice.
A
transcript
of
the
presentation
and
discussion
at
the
May
PPDC
meeting
is
in
the
public
docket
for
this
Notice.

E.
Final
Recommendations
by
AAPCO
Section
18
Task
Force
AAPCO
provided
EPA
with
their
updated
recommendations
for
improving
the
emergency
exemption
process:
1.
Multi­
year
section
18
exemptions.
EPA
should
delegate
authority
to
the
States
to
reissue
section
18
exemptions
for
a
second
or
third
year,
based
on
the
State's
confirmation
that
the
basis
for
an
emergency
situation
continues
to
exist.
2.
Resistance
management.
EPA
should
support
specific
exemptions
for
pest
resistance
management
where
there
is
documented
scientific
evidence
of
resistance
to
currently
registered
pesticides
or
where
valid
research
demonstrates
that
resistance
is
developing.
3.
Criteria
for
significant
economic
loss.
EPA
should
base
decisions
on
crop
yield
rather
than
crop
value
(
or
profit
loss)
in
situations
where
crop
yield
is
a
better
indicator
of
pest
damage.
These
are
three
of
the
eight
recommendations
originally
submitted
to
the
Agency
in
1997.
These
updated
recommendations
were
provided
to
EPA
by
AAPCO,
verbally
at
the
May
2002
PPDC
meeting,
and
again
in
a
letter
in
September
2002,
from
the
president
of
AAPCO.
A
copy
of
that
letter
is
available
in
the
public
docket
for
this
Notice.
The
three
potential
revisions
discussed
in
this
Notice
would
essentially
address
these
three
recommendations,
albeit
with
modifications
based
on
input
from
other
stakeholders.
Each
of
the
initial
eight
recommendations
has
either
been
dropped
by
AAPCO
in
their
final
recommendations,
or
is
being
addressed
in
this
Notice.

V.
Limited
Pilot
of
Potential
Process
Improvements
Beginning
with
the
2003
Growing
Season
This
limited
pilot
was
developed
after
long
and
careful
consideration
of
input
by
stakeholders.
EPA
believes
that
the
changes
being
piloted
will
significantly
benefit
both
applicants
for
pesticide
emergency
exemptions
and
the
Agency.
These
benefits
are
expected
to
accrue
without
any
increase
in
risk
to
human
health
or
the
environment.
The
pilot
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will
also
provide
valuable
information
that
will
aid
the
Agency
in
developing
and
completing
regulatory
revisions
related
to
these
process
improvements,
which
the
Agency
currently
expects
to
propose
in
2003.

A.
Which
Emergency
Exemptions
will
be
Included
in
the
Pilot?
The
pilot
will
be
limited
to
emergency
exemption
applications
for
which
the
requested
product
is
a
pesticide
previously
identified
by
EPA
as
a
reduced­
risk
pesticide,
as
discussed
below.
The
pilot
will
only
involve
specific
exemptions,
and
does
not
affect
public
health
or
quarantine
exemptions.
The
pilot
will
begin
with
emergency
exemptions
for
the
2003
growing
season.
As
such,
EPA
will
consider
the
two
process
improvements
when
it
reviews
eligible
applications
for
emergency
exemption
for
the
2003
growing
season,
including
those
applications
that
are
currently
pending
final
decision
on
and
any
applications
received
after
April
16,
2003.
The
Agency
recognizes
that
those
applications
currently
under
review
by
EPA
that
are
eligible
for
the
pilot,
are
not
likely
to
include
information
that
addresses
the
two
improvements
described
in
this
Notice.
In
such
cases,
the
Agency
intends
to
work
with
the
applicants
to
apply
the
pilot
provisions
where
appropriate
and
desired
by
the
applicant.
It
should
be
noted
that
at
no
time
during
the
pilot
is
any
applicant
required
to
use
the
pilot
provisions,
even
if
eligible.
Any
applicant
which
chooses
to
forgo
the
pilot
and
use
the
established
application
process
may
do
so.
EPA
chose
to
focus
the
pilot
on
reduced­
risk
pesticides,
a
specific
set
of
pesticide
products
which
includes
conventional
pesticides
which
were
registered
under
EPA's
Reduced­
Risk
Pesticide
Initiative,
plus
biological
pesticides
registered
through
the
Biopesticides
and
Pollution
Prevention
Division
(
BPPD).
The
goal
of
the
Reduced­
Risk
Pesticide
Initiative
and
BPPD
is
to
encourage
the
development,
registration,
and
use
of
lower­
risk
pesticide
products
which
would
result
in
reduced
risks
to
human
health
and
the
environment
when
compared
to
existing
alternatives.
A
detailed
description
of
reduced­
risk
pesticides
may
be
found
in
Pesticide
Regulation
Notice
97­
3,
which
is
available
in
the
public
docket
for
this
Notice.
The
reduced­
risk
determination
for
conventional
pesticides
is
made
by
EPA
for
each
use
of
a
pesticide,
particularly
when
compared
to
existing
registered
alternatives
for
that
use.
However,
for
use
in
implementation
of
the
revised
practices
under
the
pilot
in
this
Notice,
any
active
ingredient
which
is
contained
in
at
least
one
product
registered
under
the
Reduced­
Risk
Initiative,
plus
any
biological
pesticide,
will
be
considered
a
reduced­
risk
active
ingredient.
Any
product
containing
one
or
more
of
these
active
ingredients
and
no
others
will
be
eligible,
while
any
product
containing
any
other
active
ingredient
will
not
be
eligible
for
exemption
under
the
pilot.
EPA
has
prepared
a
list
of
all
reducedrisk
active
ingredients,
as
defined
above,
so
that
applicants
and
others
may
easily
determine
which
emergency
exemption
requests
may
be
eligible
for
consideration
under
the
pilot
for
the
revised
approach
for
documentation
of
significant
economic
loss.
The
new
economic
loss
approach
under
the
pilot
may
be
applied
to
any
exemption
request
for
a
reduced­
risk
pesticide
on
this
list.
However,
in
order
for
exemptions
to
be
eligible
for
recertification
of
an
emergency
under
the
pilot,
in
addition
to
the
restriction
to
reduced­
risk
pesticides,
they
must
also
meet
the
other
criteria
for
candidacy
for
re­
certification
set
forth
in
Unit
V.
B.
1.
Therefore,
the
Agency
has
prepared
a
second
list
of
existing
(
i.
e.,
granted
for
use
in
2002)
exemptions
that
are
eligible
for
re­
certification.
EPA
has
also
prepared
a
guidance
document
for
implementation
of
the
revised
practices
under
the
pilot,
which
is
intended
to
further
aid
applicants
in
preparing
applications.
The
two
lists
for
determining
eligibility
of
exemptions
under
the
pilot
are
appendices
to
the
guidance
document,
which
will
be
sent
to
the
States
and
included
in
the
public
docket
for
this
Notice.

B.
What
Process
Improvements
are
Being
Piloted?
Two
potential
improvements
to
the
emergency
exemption
program
will
be
tested
through
this
limited
pilot.
1.
Re­
certification
of
emergency
condition
by
applicants
 
i.
What
is
our
current
practice?
EPA
authorizes
emergency
exemptions
(
except
quarantine
exemptions)
for
no
longer
than
1
year.
However,
depending
on
the
nature
of
the
non­
routine
condition
which
caused
the
emergency,
some
exemptions
may
subsequently
be
granted
again,
1
year
at
a
time.
Currently,
EPA
conducts
a
full
review
of
an
application
for
the
first
year
of
an
exemption,
to
determine
whether
an
emergency
condition
exists,
to
ensure
the
use
will
not
result
in
unreasonable
adverse
effects
to
man
or
the
environment,
and,
if
the
use
will
result
in
pesticide
residues
in
food
or
feed,
to
make
a
safety
finding
consistent
with
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA).
Applicants
may
submit
an
application
for
a
subsequent
year,
in
which
case
the
Agency
must
again
confirm
the
emergency
condition
and
acceptability
of
the
risk.
For
requests
after
the
first
year,
the
applicant
again
submits
information
to
support
the
emergency
finding,
and
EPA
reevaluates
the
situation
to
determine,
relative
to
the
first
year,
whether:
(
1)
The
emergency
condition
has
changed;
(
2)
any
alternative
products
have
been
newly
registered
for
the
use,
or
other
effective
pest
control
techniques
are
now
available;
(
3)
any
changes
have
occurred
in
the
status
of
the
chemical's
risk
assessment;
and
(
4)
the
requested
use
pattern
has
changed.
ii.
How
will
re­
certification
work
under
the
pilot?
The
first
potential
improvement
that
is
part
of
the
pilot
will
allow
applicants
for
certain
exemptions
to
re­
certify
in
the
application
that
the
emergency
conditions
which
initially
qualified
for
an
exemption
continue
to
exist
in
the
second
and
third
years.
Under
the
pilot,
this
re­
certification
by
the
applicant
will
serve
as
the
basis
for
EPA's
determination
that
an
emergency
condition
continues
to
exist.
An
acceptable
application
which
re­
certifies
the
emergency
will
incorporate
by
reference
all
information
submitted
in
a
previous
application
or
applications
to
document
the
initial
emergency
condition
for
which
an
exemption
was
granted
previously.
Eligible
applications
in
years
two
and
three
may
consist
only
of
applicants'
re­
certification
of
the
emergency
condition,
incorporation
by
reference
of
supporting
materials,
and
specification
of
the
pesticide
application
practices
that
growers
would
observe.
Applicants
would
not
need
to
submit
new
documentation
that
the
emergency
condition
continues
or
the
additional
data
elements
generally
required
under
40
CFR
166.20.
EPA
will
apply
specific
criteria
to
determine
whether
an
exemption
request
will
be
eligible
for
recertification
of
the
emergency
condition
by
the
applicant.
All
of
the
following
criteria
need
to
apply
in
order
for
EPA
to
consider
an
exemption
as
a
candidate
for
re­
certification
of
an
emergency
under
the
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
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
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applicant,
in
order
to
establish
the
existence
of
the
emergency.
Recertifications
will
not
be
accepted
as
the
basis
for
an
emergency
after
3
years
of
an
exemption
to
an
applicant.
2.
The
emergency
situation
can
reasonably
be
expected
to
continue
for
longer
than
1
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
exemption
is
not
for
a
new
chemical,
a
first
food
use,
or
for
a
chemical
under
Special
Review.
An
exemption
that
is
for
a
product
containing
an
active
ingredient
which
has
never
been
contained
in
a
product
registered
as
a
pesticide
under
section
3
of
FIFRA,
or
has
never
been
registered
for
a
food
use,
has
officially
been
placed
under
Special
Review
by
the
Agency,
or
has
been
the
subject
of
a
Notice
of
Intent
to
Cancel
under
FIFRA
section
6,
would
not
be
considered
for
candidacy
for
recertification
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.
Under
the
pilot,
EPA
will
accept
recertifications
of
emergency
conditions
for
exemptions
which
satisfy
the
eligibility
criteria
described
above.
It
may
not
be
clear
to
applicants
whether
some
exemptions
are
eligible
for
recertification
Since
eligibility
determinations
must
be
made
by
the
Agency,
EPA
has
developed
a
list
of
emergency
exemptions
granted
for
use
in
2002
that
appear
to
be
candidates
for
re­
certification
for
the
2003
growing
season.
This
list
(
included
in
the
guidance
document
available
in
the
public
docket)
is
intended
to
help
avoid
an
applicant's
assumption
that
an
exemption
is
eligible
for
re­
certification
of
the
emergency,
when
in
fact
it
is
not.
EPA
will
attempt
to
include
all
appropriate
candidates
on
this
list.
However,
applicants
may
contact
the
Agency
to
request
an
eligibility
determination
for
exemptions
they
believe
satisfy
the
criteria
but
which
are
not
on
the
list.
For
applications
which
are
eligible
and
include
a
proper
re­
certification
of
the
emergency
condition,
EPA
will
continue
to
assess
whether
the
requested
use
poses
a
risk
to
human
health
or
the
environment
that
exceeds
statutory
and
regulatory
standards.
If
the
risks
posed
by
the
requested
use
are
determined
to
be
unacceptable,
the
exemption
request
will
be
denied.
However,
when
the
emergency
condition
and
requested
use
in
an
eligible
year
are
the
same
as
in
the
initial
year
of
the
exemption,
EPA
will
only
re­
evaluate
the
situation
to
determine,
relative
to
the
first
year,
whether:
(
1)
Any
alternative
products
have
been
newly
registered
for
the
use;
(
2)
any
changes
have
occurred
in
the
status
of
the
chemical's
risk
assessment;
and
(
3)
the
requested
use
pattern
has
changed.
If
an
effective
product
has
been
registered
for
the
requested
use
since
the
previous
exemption
was
granted,
then
an
emergency
condition
no
longer
exists.
If
the
Agency
has
received
new
risk
information
since
granting
the
previous
exemption,
then
the
risk
will
be
re­
evaluated.
Likewise,
if
the
request
includes
any
change
in
the
use
pattern
which
may
increase
exposure
(
application
rate,
number
of
applications,
type
of
application,
preharvest
interval,
re­
entry
interval,
total
number
of
acres,
and
all
other
directions
for
use)
then
the
risk
will
also
be
reevaluated
For
eligible
requests
with
applicant
certification
of
a
continuing
emergency,
if
the
three
remaining
review
factors
(
product
registrations,
risk
assessment
status,
and
requested
use
pattern)
have
not
changed,
the
Agency's
review
time
is
expected
to
be
significantly
reduced.
In
such
cases,
applicants
are
expected
to
benefit
by
expedited
decisions,
in
addition
to
the
reduced
burden
due
to
the
certification
of
the
emergency.
Applicants
will
be
permitted
to
modify
the
use
pattern
for
the
emergency
program
in
an
application
in
which
they
re­
certify
the
emergency.
However,
EPA
will
need
to
determine
whether,
and
how,
such
changes
impact
exposure
and
risk
to
human
health
or
the
environment.
Therefore,
these
changes
may
undercut
the
ability
of
applicants
to
receive
an
expedited
Agency
decision.
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.
If
the
Agency
determines
that
there
has
been
insufficient
progress
towards
registration
of
the
requested
chemical
on
the
requested
crop,
a
request
could
be
denied,
consistent
with
current
regulations
and
practice,
regardless
of
eligibility
for
re­
certification.
Progress
toward
registration
is
determined
for
a
pesticide­
crop
combination,
whereas
the
year­
count
(
first,
second,
third,
etc.)
in
the
eligibility
cycle
for
re­
certification
would
be
determined
separately
for
each
applicant,
and
could
often
differ
among
applicants
in
a
given
year.
Lack
of
progress
towards
registration
would
generally
not
cause
denials
during
the
first
3
years
of
exemptions
for
a
chemical­
crop
combination.
However,
since
some
applicants
may
apply
for
the
first
time,
in
a
year
subsequent
to
the
first
request
for
a
chemical­
crop
combination
by
another
applicant,
lack
of
progress
towards
registration
could
potentially
interrupt
the
eligibility
cycle
for
some
applicants.
EPA
is
sensitive
to
emergency
exemption
requests
being
repeated
for
a
number
of
years
and
requires
that
steps
be
taken
to
obtain
a
registration
for
the
emergency
use.
Under
this
pilot
for
recertifiable
emergencies,
EPA
will
not
allow
re­
certification
of
emergencies
for
exemptions
that
have
been
granted
for
more
than
3
years.
iii.
Why
pilot
this
potential
improvement?
Allowing
applicants
to
re­
certify
the
existence
of
an
ongoing
emergency
condition
for
certain
eligible
exemption
requests
is
expected
to
reduce
the
burden
to
both
applicants
and
EPA
as
well
as
allow
for
quicker
decisions.
When
an
applicant
certifies
the
continuation
of
the
emergency
condition
and
incorporates
previously
submitted
materials
by
reference,
a
complete
new
application
sufficient
to
characterize
the
situation
in
accordance
with
40
CFR
166.20
will
not
be
required.
This
will
save
applicants
time
and
effort
in
gathering
data
and
preparing
their
submissions.
The
Agency
will
save
time
and
resources
by
not
having
to
annually
repeat
the
analyses
that
support
the
applicable
requests.
If
no
pesticides
which
can
avert
the
emergency
have
been
newly
registered,
and
nothing
has
changed
to
affect
the
assessment
of
risk,
then
recertification
of
an
emergency
will
lead
to
significantly
shorter
Agency
review,
saving
valuable
time
for
those
affected
by
the
emergency.
EPA's
experience
indicates
that
emergency
situations
which
continue
after
the
initial
year
generally
cause
comparable
losses
in
succeeding
years.
Therefore,
with
the
certification
of
a
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Notices
continuing
emergency,
the
economic
data
and
other
supporting
information
required
by
40
CFR
part
166
would
be
unnecessary.
The
limited
focus
of
the
pilot
on
reduced­
risk
pesticides
will
significantly
reduce
the
number
of
exemptions
potentially
affected
under
the
pilot.
Nevertheless,
the
Agency
expects
the
pilot
to
provide
valuable
experience.
Any
available
information
from
the
pilot
will
be
considered
along
with
public
comments
in
forming
a
better
proposed
rule
that
EPA
currently
intends
to
issue
in
2003
and
aid
in
the
development
of
final
improvements
to
the
emergency
exemption
program.
2.
Tiered
approach
for
documentation
of
``
significant
economic
loss''
 
i.
What
is
our
current
practice?
EPA
determines
whether
the
loss
from
an
emergency
would
result
in
net
cash
returns
(
gross
revenue
less
operating
expenses)
below
the
historical
variation
in
net
cash
returns.
Applicants
are
required
to
submit
economic
information
necessary
to
make
this
determination,
when
available.
In
addition
to
information
used
to
estimate
the
amount
of
the
anticipated
yield
and
profit
losses,
annual
data
for
5
years
of
average
yields,
prices,
and
production
costs
are
submitted
by
applicants
and
analyzed
by
EPA
to
establish
profit
variability.
ii.
How
will
the
tiered
approach
to
determining
significant
economic
loss
be
used
under
the
pilot?
A
large
majority
of
emergency
exemptions
are
granted
because
they
meet
the
regulatory
criteria
for
an
emergency
condition
that
affected
growers
will
suffer
a
``
significant
economic
loss''
due
to
an
urgent,
non­
routine
situation
if
the
requested
exemption
is
not
granted.
This
second
potential
improvement
that
is
part
of
the
pilot
will
allow
applicants
to
develop
the
significant
economic
loss
documentation
necessary
to
support
many
specific
exemption
requests
through
a
less
burdensome
economic
methodology.
This
tiered
approach
is
based
on
an
analysis
of
data
found
in
a
random
selection
of
past
requests
for
emergency
exemptions
submitted
by
States,
including
requests
that
were
denied.
The
analysis
shows
that
in
many
cases
significant
economic
loss
can
be
demonstrated
in
a
more
flexible
manner
without
loss
of
reliability.
The
analysis
of
past
section
18
requests
suggests
that
the
current
approach
is
often
unnecessarily
burdensome
in
terms
of
information
requirements.
This
new
approach
under
the
pilot
will
often
reduce
the
burden
to
applicants
relative
to
the
current
approach,
while
maintaining
the
level
of
approvals
of
current
regulations.
The
tiered
approach
is
intended
to
require
less
data
from
applicants
in
cases
where
the
same
conclusion
of
a
significant
economic
loss
would
be
made
with
the
additional
data
and
analysis.
Current
regulations
(
40
CFR
166.20(
b))
list
certain
information
which
must
be
included,
as
appropriate,
in
an
application
for
a
specific
exemption:
(
b)
Information
required
for
a
specific
exemption.
An
application
for
a
specific
exemption
shall
provide
all
of
the
following
information,
as
appropriate,
concerning
the
nature
of
the
emergency:
(
4)
A
discussion
of
the
anticipated
significant
economic
loss,
together
with
data
and
other
information
supporting
the
discussion,
which
addresses
all
of
the
following:
(
i)
Historical
net
and
gross
revenues
for
the
site;
(
ii)
The
estimated
net
and
gross
revenues
for
the
site
without
the
use
of
the
proposed
pesticide;
and
(
iii)
The
estimated
net
and
gross
revenues
for
the
site
with
use
of
the
proposed
pesticide.

The
regulations
state
that
all
of
the
above
information
must
be
included
``
as
appropriate.''
EPA
exercises
judgement
based
on
experience,
in
determining
when
something
less,
or
different,
is
appropriate.
For
example,
under
the
current
approach
the
Agency
typically
considers
5
years
of
annual
data
on
historical
net
and
gross
revenues
to
be
appropriate,
although
the
regulations
do
not
prescribe
5
years.
However,
in
some
cases,
such
as
a
very
minor
or
new
crop
for
which
less
data
are
available,
this
requirement
is
not
considered
appropriate
if
the
applicant
substitutes
other
credible
information.
Therefore,
EPA
believes
that
the
pilot
approach
will
allow
applicants
to
focus
their
applications
on
the
most
``
appropriate''
information
for
determining
whether
or
not
a
significant
economic
loss
will
occur.
Because
the
analysis
of
past
exemption
requests,
on
which
the
pilot
approach
is
based,
demonstrates
that
the
likelihood
of
approval
of
some
requests
is
not
significantly
changed
by
the
pilot
tiered
approach,
EPA
believes
that
the
requirement
of
those
data
in
those
cases
is
not
appropriate.
However,
even
when
annual
historical
data
are
not
required,
applicants
would
generally
continue
to
utilize
historical
data
under
the
pilot
approach,
albeit
in
a
different
way.
Each
tier
requires
a
quantitative
threshold
to
be
met,
which
is
a
certain
percentage
of
a
baseline
of
either
crop
yield,
gross
revenues,
or
net
revenues.
The
best
approach
to
determine
the
baseline
in
most
cases
is
to
use
the
average
of
historical
data,
including
yield
and
price
data.
Whereas
the
existing
method
generally
requires
detailed
historical
data,
with
the
new
approach
the
analytical
burden
for
determining
significant
economic
loss
will
be
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
could
qualify
based
on
further
analysis
in
succeeding
tiers.
Each
additional
tier
would
require
more
data
and
involve
more
analysis
on
how
the
emergency
affects
profitability.
For
a
loss
to
be
considered
economically
significant,
it
must
exceed
a
threshold.
Each
tier
has
a
quantitative
threshold
that
will
generally
apply
to
all
eligible
emergency
exemption
applications.
Where
conditions
do
not
neatly
fit
into
the
tiered
approach,
for
example
long­
term
losses
in
orchard
crops,
the
Agency
may
make
a
finding
of
significant
economic
loss
based
on
other
criteria,
such
as
changes
in
the
net
present
value
of
an
orchard,
if
these
losses
are
demonstrated
by
the
State.
Tier
1­­
Yield
Loss.
Tier
1
is
based
on
crop
yield
loss.
If
the
projected
yield
loss
due
to
the
emergency
condition
is
sufficiently
large,
EPA
will
conclude
that
a
significant
economic
loss
will
occur,
due
to
the
magnitude
of
the
expected
revenue
loss.
The
yield
loss
threshold
in
Tier
1
will
be
20%
for
all
crops.
This
threshold
is
set
at
a
sufficiently
high
level
such
that
a
loss
which
exceeds
the
threshold
will
also
meet
the
thresholds
in
Tiers
2
and
3,
if
the
additional
economic
data
were
submitted
and
analyzed.
Therefore,
for
such
large
yield
losses
it
will
not
be
appropriate
or
necessary
to
separately
estimate
economic
loss,
which
requires
detailed
economic
data.
Tier
2­­
Economic
Loss
as
a
Percentage
of
Gross
Revenues.
A
yield
loss
which
does
not
satisfy
the
threshold
in
Tier
1
could
also
lead
to
a
significant
economic
loss
because
yield
loss
may
not
capture
all
economic
losses.
In
addition
to
yield
losses
there
may
be
other
impacts
that
affect
economic
loss,
including
quality
losses
and
changes
in
production
costs,
such
as
pest
control
costs
and
harvesting
costs.
For
situations
with
yield
losses
that
do
not
meet
the
significant
economic
loss
criterion
for
Tier
1,
EPA
will
evaluate
estimates
of
economic
loss
as
a
percent
of
gross
revenue
in
Tier
2,
to
determine
if
the
loss
meets
that
threshold
for
a
significant
economic
loss.
The
economic
loss
threshold
in
Tier
2
will
be
20%
of
gross
revenue
for
all
crops.
Again,
this
threshold
in
Tier
2
is
set
with
the
intention
that
losses
exceeding
the
threshold
also
meet
the
threshold
in
Tier
3,
if
it
were
analyzed.

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24,
2003
/
Notices
Tier
3­­
Economic
Loss
as
a
Percentage
of
Net
Revenues.
Because
typical
profit
margins
(
net
cash
revenues
as
a
percentage
of
gross
revenues)
vary
among
crops,
EPA
will
consider
impacts
on
net
cash
revenues
in
Tier
3
if
neither
yield
or
economic
losses
are
above
the
required
thresholds
in
Tiers
1
and
2.
Specifically,
Tier
3
will
measure
economic
loss
as
a
percent
of
net
cash
revenues.
The
loss
threshold
in
Tier
3
will
be
50%
of
net
cash
revenues
for
all
crops
during
the
pilot.
Some
emergency
conditions
which
fall
short
of
the
thresholds
in
Tiers
1
and
2
may
qualify
as
a
significant
economic
loss
in
Tier
3,
particularly
for
crops
with
narrow
profit
margins.
Even
if
economic
loss
seems
small
in
comparison
to
gross
revenues,
the
situation
could
still
be
determined
to
be
a
significant
economic
loss
if
the
profit
margin
is
narrow.
For
those
emergency
exemptions
in
which
significant
economic
loss
is
a
qualifying
factor,
applicants
will
determine
which
tier
their
situation
is
expected
to
qualify
under,
specify
that
tier
in
their
request,
and
submit
the
data
necessary
for
analysis
under
that
tier.
The
three
tiers
are
designed
such
that
when
an
emergency
condition
qualifies
for
significant
economic
loss
under
a
lower
tier,
data
for
higher
tiers
is
not
required,
and
the
burden
and
cost
are
reduced.
Each
successive
tier
builds
upon
the
previous
one.
That
is,
the
information
required
for
estimating
a
lower
tier
is
also
necessary
in
estimating
each
higher
tier.
This
will
allow
an
applicant
to
collect
data,
and
build
a
case
for
significant
economic
loss,
as
needed
and
determined
by
the
conditions.
iii.
Why
pilot
this
potential
improvement?
This
new
methodology
for
determining
a
significant
economic
loss
is
intended
to
streamline
the
data
and
analytical
requirements
for
emergency
exemption
requests.
In
addition,
the
methodology
is
designed
to
be
more
flexible
than
the
existing
procedure
for
determining
a
significant
economic
loss.
Specifically,
the
Agency
believes
this
approach
makes
a
better
comparison
between
the
emergency
situation
and
what
would
exist
without
the
emergency,
rather
than
a
comparison
with
the
past.
An
analysis
of
past
section
18
requests
suggests
that
this
new
approach
will
not
cause
a
significant
change
in
the
overall
likelihood
of
a
significant
economic
loss
finding,
although
findings
may
differ
in
individual
cases.
Further,
it
is
expected
to
lead
to
considerable
savings
to
both
applicants
and
EPA
from
reduced
data
and
analytical
burdens.
Under
the
pilot
procedure,
applicants
may
elect
to
submit
the
minimum
amount
of
data
necessary
to
demonstrate
a
significant
economic
loss
in
one
of
three
increasingly
refined
tiers.
If
the
first
tier
is
sufficient,
the
burden
is
reduced
most
significantly.
Even
in
the
highest
tier,
the
burden
may
be
reduced
relative
to
the
old
approach
as
the
analysis
focuses
on
the
current
year
rather
than
historical
data.
Like
re­
certification
of
emergencies,
this
will
save
applicants
time
and
resources
in
gathering
data
and
preparing
submissions.
The
Agency's
burden
will
be
reduced
due
to
streamlined
reviews.
As
with
re­
certification
of
emergencies,
the
Agency
expects
the
pilot
to
provide
useful
experience
with
the
tiered
approach
for
documentation
of
significant
economic
loss.
That
experience
will
be
considered
along
with
public
comments
to
assist
in
the
planned
rulemaking
process
for
improving
the
emergency
exemption
regulations.
The
Agency
will
analyze
the
selected
threshold
levels
during
the
pilot
period
to
confirm
that
they
are
appropriate,
and
also
use
any
helpful
information
supplied
in
public
comments.
EPA
will
also
scrutinize
the
approach
of
using
a
uniform
threshold
level
in
each
tier
for
all
crops,
and
consider
whether
different
levels
for
various
crop
groups
would
be
more
appropriate.

VI.
Request
for
Comment
A.
Comment
Sought
on
Improvements
Being
Piloted
The
Agency
seeks
comment
on
the
potential
changes
included
in
the
limited
pilot
described
in
Unit
V.,
and
on
how
those
provisions
should
be
implemented
through
a
future
rulemaking.
EPA
currently
intends
to
publish
a
proposed
rule
in
2003
that
will
propose
several
potential
improvements
to
the
emergency
exemption
regulations.
EPA
will
consider
any
available
information
from
this
pilot
as
it
proceeds
with
rulemaking.
If
the
re­
certification
process
is
fully
implemented
through
rulemaking,
the
eligibility
criteria
established
in
that
rulemaking
would
become
final,
and
may
differ
from
the
criteria
under
the
pilot.
The
Agency
expects
that
after
such
a
final
rule,
whenever
EPA
granted
an
exemption,
and
classified
it
as
a
candidate
for
re­
certification,
it
would
also
include
in
the
approval
letter
the
number
of
years
of
candidacy
remaining
at
that
time
(
i.
e.,
1
or
2
years).
This
notification
in
the
approval
letter
of
candidacy
for
the
following
year
will
not
occur
during
the
pilot,
as
the
criteria
under
the
pilot
are
not
final.
Instead,
EPA
will
prepare
a
list
of
candidate
exemptions
(
see
Unit
V.
A.)
for
each
year
that
the
pilot
is
in
effect.
The
scope
of
the
pilot
is
purposely
limited
to
reduced­
risk
pesticides
in
order
to
significantly
reduce
the
number
of
exemptions
potentially
affected,
while
still
benefiting
from
the
experience
of
the
potential
improvements
to
inform
the
rulemaking
process.
However,
EPA
does
not
anticipate
that
the
improvements
being
piloted
should
be
limited
to
reducedrisk
pesticides
in
a
final
rule.

B.
Comment
Sought
on
Consideration
of
Resistance
Management
Exemptions
Although
not
included
in
the
limited
pilot
described
in
this
Notice,
the
Agency
is
considering
another
potential
improvement
to
the
emergency
exemption
program,
i.
e.,
whether
to
allow
exemptions
for
pest
resistance
management
purposes.
This
potential
improvement
was
not
included
in
the
pilot
due
to
uncertainty
and
complexity
of
issues
with
respect
to
the
appropriate
requirements
for
scope
and
degree
of
resistance
development,
as
well
as
level
and
type
of
documentation.
To
aid
the
Agency
in
developing
this
potential
improvement
for
inclusion
in
the
proposed
rule
that
is
currently
expected
in
2003,
the
Agency
specifically
seeks
comment
on
this
additional
potential
improvement
to
the
emergency
exemption
program
that
would
allow
exemptions
for
resistance
management
under
specific
criteria
where
pest
resistance
to
registered
pesticides
is
developing
or
has
developed.
1.
What
is
our
current
practice?
Exemptions
are
only
authorized
for
resistance
management
in
cases
where
documented
pest
resistance
to
the
registered
pesticide
has
already
developed
and
use
of
the
registered
pesticide
is
expected
to
result
in
significant
economic
losses.
Under
current
regulations,
if
there
is
at
least
one
available
registered
pesticide
that
is
effective
enough
to
prevent
significant
economic
losses,
then
the
situation
is
generally
not
found
to
be
an
emergency
regardless
of
whether
or
not
the
alternative
is
considered
to
be
vulnerable
to
the
development
of
resistance
by
the
target
pest.
2.
How
might
resistance
management
exemptions
work?
Some
emergencies
are
the
result
of
the
development
of
pest
resistance
to
a
registered
pesticide
that
is
essential
for
the
management
of
a
pest
which,
unchecked,
can
cause
significant
economic
loss.
The
optimal
time
to
respond
to
this
emergency
would
be
early
enough
to
prevent
or
retard
the
development
of
widespread
resistance.
Timely
action
in
granting
the
emergency
use
of
another
pesticide
could
increase
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the
useful
life
of
the
essential
registered
pesticide
and
ultimately
limit
the
need
for
more
emergency
exemptions.
The
potential
improvement
would
take
a
more
preventive
approach
to
resistance
management.
Under
such
an
approach,
EPA
could
review
applications
and
look
for
all
four
of
the
following
criteria
before
approving
an
emergency
exemption
request
for
resistance
management:
i.
Pest
resistance
is
developing
or
has
developed
to
the
registered
pesticide
product.
Claims
that
a
pest
is
developing
or
has
developed
resistance
to
a
pesticide
should
be
documented
by
scientific
evidence.
The
applicant
would
submit
the
best
readily
available
information
which
supports
their
case.
Because
acceptable
techniques
for
verifying
resistance
vary
considerably
for
the
numerous
crop­
pest­
pesticide
combinations,
EPA
determinations
on
sufficiency
of
documentation
would
be
made
on
a
case­
by­
case,
weight­
of­
theevidence
basis.
Resistance
development
would
be
documented
through
field
studies,
references
to
field
studies,
or
loss
of
ability
to
control
the
pest
in
the
field
and
confirmed
to
be
due
to
pest
resistance
in
commercial
plantings
or
other
actual
use
conditions
such
as
in
greenhouses.
Typically,
documentation
of
a
decrease
in
susceptibility
to
a
pesticide
would
involve
collections
of
pest
samples
from
fields
suspected
of
containing
high
frequencies
of
resistant
pests,
and
laboratory
bioassay
would
be
conducted
to
estimate
the
frequency
of
resistant
individuals
and
the
degree
of
resistance.
Field
tests
would
be
conducted
to
assess
the
degree
to
which
the
laboratory
resistant
bioassay
reflects
loss
of
efficacy
under
typical
treatment
conditions
in
the
field.
Because
resistance
developed
or
measured
under
laboratory
or
other
non­
field
conditions
may
not
accurately
reflect
conditions
in
normal
use
situations,
the
applicant
would
need
to
demonstrate
that
the
data
presented
can
substitute
for
field
conditions.
That
is,
the
laboratory
bioassay
must
have
relevance
to
the
field
such
that
individuals
shown
to
be
resistant
in
the
laboratory
bioassay
actually
do
contribute
to
a
substantial
loss
of
efficacy
under
the
treatment
conditions
of
the
field.
The
data
should
reflect
numerous
susceptibility
estimates
within
single
locations
and
multiple
locations
to
confirm
resistance
and
account
for
within­
field
variability.
The
geographic
extent
of
resistant
populations
should
be
described.
The
applicant
could
present
evidence
on
previously
reported
resistance
incidences
that
are
substantially
similar
to
the
pest
situation
under
consideration,
as
well
as
a
rationale
for
why
resistance
is
anticipated.
Applicable
situations
include
those
where
resistance
has
been
documented,
either
in
the
U.
S.
or
outside
the
U.
S.,
for
the
same
pest
species
or
related
pest
species,
similar
pesticide
use
patterns,
and
comparable
climatic
conditions.
Documentation
of
comparable
situations
should
also
include
evidence
that
the
loss
of
efficacy
was
not
due
to
misapplication,
weather,
or
other
effects
not
due
to
resistance.
Documented
field
failures
due
to
pest
resistance
outside
the
U.
S.
and/
or
laboratory
or
noncommercial
greenhouse
experiments
could
also
be
included
to
substantiate
resistance
in
the
same
or
closely
related
pest
species.
However,
evidence
should
be
presented
to
justify
the
use
of
related
pest
species,
since
even
closely
related
pest
species
may
have
a
different
genetic
potential
to
develop
resistance.
Information
should
be
provided
on
the
genetic,
biological
(
biotic
and
behavioral),
and
operational
(
chemical
and
application
technology)
characteristics
that
influenced
the
selection
of
resistance.
Evidence
should
be
provided
that
indicates
the
typical
number
and
frequency
of
pesticide
applications,
and
rate
of
application
used,
and
host,
and
why
the
target
pest
is
likely
to
develop
or
has
developed
resistance
at
the
requested
and/
or
reported
site(
s),
country,
county,
State,
or
region.
The
applicant
must
also
discuss
what
has
been
done
to
manage
resistance
to
the
existing
registered
alternatives
and
why
the
requested
pesticide
is
essential
to
managing
pest
resistance.
This
information
is
important
for
understanding
the
basis
of
resistance
and
choosing
appropriate
strategies
to
manage
it.
ii.
The
registered
chemical
to
which
resistance
is
developing
is
considered
essential
for
the
management
of
the
pest(
s)
in
the
particular
crop.
The
pesticide
to
which
resistance
is
developing
should
be
a
registered
pesticide
which
serves
as
the
standard
treatment,
is
critical
for
obtaining
control
of
the
emergency
pest,
and
for
which
suitable
registered
alternatives
are
lacking.
If
the
registered
pesticide
is
used
only
rarely,
the
likelihood
of
resistance
developing
is
generally
greatly
reduced.
Applicants
would
be
asked
to
document
that
the
pest
is
one
which
occurs
regularly
in
the
subject
crop
and
State,
and
is
capable
of
causing
a
significant
economic
loss
(
see
Unit
V.
B.)
if
no
effective
control
were
available.
This
criterion
would
ensure
that,
while
addressing
resistance
proactively
by
preventing
future
emergency
conditions
before
they
occur,
the
scope
of
these
exemptions
would
not
include
those
for
which
an
actual
emergency
would
never
occur.
iii.
The
request
is
for
only
one
chemical,
which
is
in
a
different
class,
or
has
a
different
mode
of
action,
from
the
registered
chemical
to
which
resistance
is
developing.
Applicants
would
be
asked
to
provide
evidence
to
demonstrate
that
the
requested
chemical
has
a
different
mode/
mechanism
of
action,
metabolic
effect,
behavioral
response,
target
enzyme,
or
target
life
stage
from
the
available
effective
registered
pesticides.
Evidence
should
also
be
presented
regarding
whether
the
requested
pesticide
may
result
in
unintended
pesticide
exposure
in
nontarget
pests,
if
available.
Pesticide
Registration
Notice
2001
 
5,
available
in
the
public
docket
for
this
Notice
and
on
the
Internet
at
http://
www.
epa.
gov/
opppmsd1/
PR
l
Notices/
pr2001
 
5.
pdf,
describes
the
Agency's
voluntary
policy
toward
resistance
management
based
on
mode
of
action.
The
Appendices
of
that
document
provide
the
mode
of
action
classification
of
all
of
the
available
registered
active
ingredients
for
insecticides,
miticides,
acaricides,
fungicides,
bactericides,
and
herbicides
for
agricultural
uses.
iv.
The
applicant
has
a
credible
approach
to
managing
the
development
of
resistance
using
both
the
requested
chemical
and
the
chemical
to
which
resistance
is
developing.
The
applicant
would
be
asked
to
include
various
pest
management
strategies
to
reduce
selection
pressure
to
not
only
the
requested
pesticide,
but
also
the
registered
alternatives
that
still
may
have
utility.
When
available,
the
applicant
should
also
include
supplemental
control
measures
for
reducing
selection
pressure,
especially
those
of
a
non­
chemical
nature
(
e.
g.,
biocontrol,
scouting,
cultural
practices,
crop
rotation,
and
use
of
a
pest
forecasting
system).
Management
tactics
might
also
include
biological
and
ecological
factors
that
influence
pest
migration,
dispersion,
or
overwintering,
for
example.
Management
strategies
should
consider
all
useful
information
on
the
stability
and
inheritance
of
resistance
(
cross­
and
multiple
resistance)
and
relevant
information
on
pest
ecology,
biology,
and
toxicology.
3.
Why
is
this
potential
improvement
being
considered?
EPA
believes
that
granting
emergency
exemptions
on
the
basis
of
resistance
management
is
a
proactive
approach
for
addressing
the
development
of
resistance
in
its
early
stages,
thereby
preventing
significant
economic
losses
before
they
occur.
Availability
of
an
additional
pesticide
for
resistance
management
may
reduce
the
likelihood
of
the
common
scenario
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of
increasing
frequency
and
rate
of
application
of
a
single
available
pesticide
with
decreasing
effectiveness.
Therefore,
a
decrease
in
risk
to
man
and
the
environment
is
expected
to
accompany
the
economic
benefit
to
pesticide
users.
4.
Are
there
particular
questions
to
consider
in
preparing
comments?
The
Agency
is
looking
for
specific
comments
on
the
types
of
data
or
documentation
to
demonstrate
resistance
and
the
proposed
approach
for
this
type
of
emergency
exemption.
In
order
to
help
focus
public
comments
on
the
resistance
management
proposal,
the
following
questions
and
issues
are
offered
for
consideration
and
comment:
i.
There
is
likely
to
be
some
delay
in
confirming
resistance
in
the
field
once
it
is
suspected.
Given
this
circumstance,
what
level
of
documentation
would
be
appropriate
through
laboratory,
greenhouse,
or
field
studies
either
in
county,
State,
region,
inside
or
outside
the
U.
S.?
ii.
How
should
noted
resistance
in
related
pest
species
be
used
to
aid
a
request?
iii.
How
many
years
of
field
data
and
how
many
geographic
locations
would
one
need
to
establish
a
reasonable
case
for
pest
resistance?
iv.
Comments
are
requested
on
the
documentation
of
cross­
resistance
potential.
v.
Should
emergency
exemptions
for
resistance
management
be
limited
to
requests
for
chemicals
in
a
different
class,
or
with
a
different
mode
of
action,
than
the
chemical
to
which
resistance
is
developing?
vi.
What
evidence
should
be
provided
to
demonstrate
the
likely
effectiveness
of
proposed
management
strategies
to
manage
resistance?

C.
General
Considerations
for
Commenters
As
you
prepare
comments
for
submission
to
EPA,
you
may
find
the
following
suggestions
helpful:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
Notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
Notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

List
of
Subjects
Environmental
protection,
Pesticides,
Emergency
exemptions.

Dated:
April
16,
2003.
Stephen
L.
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
03
 
10169
Filed
4
 
23
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
MARITIME
COMMISSION
Notice
of
Agreement(
s)
Filed
The
Commission
hereby
gives
notice
of
the
filing
of
the
following
agreement(
s)
under
the
Shipping
Act
of
1984.
Interested
parties
can
review
or
obtain
copies
of
agreements
at
the
Washington,
DC
offices
of
the
Commission,
800
North
Capitol
Street,
NW.,
Room
940.
Interested
parties
may
submit
comments
on
an
agreement
to
the
Secretary,
Federal
Maritime
Commission,
Washington,
DC
20573,
within
10
days
of
the
date
this
notice
appears
in
the
Federal
Register.
Agreement
No.:
011835
 
001.
Title:
CMA
CGM/
CNAN
Space
Charter
Pooling
and
Cooperative
Working
Agreement.
Parties:
CMA
CGM
Societe
Nationale
de
Transports
Maritimes­
CNAN.
Synopsis:
The
proposed
agreement
modification
would
permit
the
parties
to
include
in
their
revenue
pool
freights
received
from
the
carriage
of
containers
on
deck.

By
Order
of
the
Federal
Maritime
Commission.

Dated:
April
21,
2003.
Bryant
L.
VanBrakle,
Secretary.
[
FR
Doc.
03
 
10174
Filed
4
 
23
 
03;
8:
45
am]

BILLING
CODE
6730
 
01
 
P
FEDERAL
RESERVE
SYSTEM
Formations
of,
Acquisitions
by,
and
Mergers
of
Bank
Holding
Companies
The
companies
listed
in
this
notice
have
applied
to
the
Board
for
approval,
pursuant
to
the
Bank
Holding
Company
Act
of
1956
(
12
U.
S.
C.
1841
et
seq.)
(
BHC
Act),
Regulation
Y
(
12
CFR
Part
225),
and
all
other
applicable
statutes
and
regulations
to
become
a
bank
holding
company
and/
or
to
acquire
the
assets
or
the
ownership
of,
control
of,
or
the
power
to
vote
shares
of
a
bank
or
bank
holding
company
and
all
of
the
banks
and
nonbanking
companies
owned
by
the
bank
holding
company,
including
the
companies
listed
below.
The
applications
listed
below,
as
well
as
other
related
filings
required
by
the
Board,
are
available
for
immediate
inspection
at
the
Federal
Reserve
Bank
indicated.
The
application
also
will
be
available
for
inspection
at
the
offices
of
the
Board
of
Governors.
Interested
persons
may
express
their
views
in
writing
on
the
standards
enumerated
in
the
BHC
Act
(
12
U.
S.
C.
1842(
c)).
If
the
proposal
also
involves
the
acquisition
of
a
nonbanking
company,
the
review
also
includes
whether
the
acquisition
of
the
nonbanking
company
complies
with
the
standards
in
section
4
of
the
BHC
Act
(
12
U.
S.
C.
1843).
Unless
otherwise
noted,
nonbanking
activities
will
be
conducted
throughout
the
United
States.
Additional
information
on
all
bank
holding
companies
may
be
obtained
from
the
National
Information
Center
Web
site
at
www.
ffiec.
gov/
nic/.
Unless
otherwise
noted,
comments
regarding
each
of
these
applications
must
be
received
at
the
Reserve
Bank
indicated
or
the
offices
of
the
Board
of
Governors
not
later
than
May
19,
2003.
A.
Federal
Reserve
Bank
of
Dallas
(
W.
Arthur
Tribble,
Vice
President)
2200
North
Pearl
Street,
Dallas,
Texas
75201
 
2272:
1.
AIM
Bancshares,
Inc.,
Levelland,
Texas;
to
become
a
bank
holding
company
by
acquiring
68.47
percent
of
the
voting
shares
of
The
First
National
Bank
of
Littlefield,
Littlefield,
Texas.

Board
of
Governors
of
the
Federal
Reserve
System,
April
18,
2003.
Jennifer
J.
Johnson,
Secretary
of
the
Board.
[
FR
Doc.
03
 
10077
Filed
4
 
23
 
03;
8:
45
am]

BILLING
CODE
6210
 
01
 
S
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
Centers
for
Disease
Control
and
Prevention
[
Program
Announcement
03045]

Sexually
Transmitted
Disease
(
STD)
Prevention
Program
Communication
Network;
Notice
of
Availability
of
Funds
Application
Deadline:
June
23,
2003.

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18:
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2003
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