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30,
2004
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1
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20
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection:
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
NO.:
2070­
0032
EPA
NO.:
0596.09
1(
b)
Short
Characterization/
Abstract
This
Information
Collection
Request
(
ICR)
is
a
renewal
of
an
existing
ICR
that
is
currently
approved
by
OMB
and
is
due
to
expire
November
30,
2004.
Section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizes
the
Environmental
Protection
Agency
(
EPA)
to
grant
emergency
exemptions
to
states
and
Federal
agencies
to
allow
an
unregistered
use
of
a
pesticide
for
a
limited
time
if
EPA
determines
that
emergency
conditions
exist.
This
data
collection
program
is
designed
to
provide
EPA
with
necessary
data
to
evaluate
an
application
for
a
permit
for
the
temporary
use
of
a
pesticide
product
for
an
unregistered
use
to
mitigate
an
emergency
situation.
The
information
is
used
by
EPA
to
evaluate
whether
an
emergency
condition
exists,
whether
use
of
the
pesticide
under
the
exemption
will
be
protective
of
human
health
and
the
environment,
and
to
evaluate
the
effectiveness
of
the
requested
product
in
allaying
the
emergency.

Most
requests
for
emergency
exemptions
are
made
by
state
lead
agricultural
agencies,
although
agencies
such
as
the
United
States
Departments
of
Agriculture
(
USDA),
Defense
(
DOD)
and
Interior
(
USDI)
also
request
exemptions.
This
process
is
generally
initiated
when
growers
in
particular
regions
identify
an
urgent,
non­
routine
situation
which
registered
pesticides
will
not
alleviate.
The
growers
contact
their
state
lead
agency
(
usually
the
state
department
of
agriculture)
and
request
that
the
agency
apply
to
EPA
for
a
Section
18
emergency
exemption
for
a
particular
use.
Requests
are
most
often
made
for
pesticides
that
have
other
food
uses
registered.
The
state
agency
evaluates
the
requests
and
submits
requests
to
EPA
for
emergency
exemptions
they
believe
are
warranted.
The
uses
are
requested
for
a
limited
period
of
time
to
address
the
emergency
situation
only.

Requests
for
Section
18
emergency
exemptions,
i.
e.,
the
submission
of
applications,
are
at
the
discretion
of
a
state,
U.
S.
territory,
or
federal
agency.
Should
one
of
these
entities
apply
for
an
emergency
exemption,
EPA
requests
the
information
and
data
identified
under
Section
3
of
this
supporting
statement.
If
the
emergency
appears
valid
and
the
risks
are
acceptable,
EPA
typically
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30,
2004
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approves
the
emergency
exemption
request.
EPA
will
deny
an
exemption
request
if
the
pesticide
use
may
cause
unreasonable
adverse
effects
to
human
health
or
the
environment,
or
if
emergency
criteria
are
not
met.
As
a
matter
of
course,
a
state
may
withdraw
an
exemption
request
at
any
point
in
the
process.
If
a
need
is
immediate,
allowing
insufficient
time
for
the
application
and
review
process,
a
state
agency
may
issue
a
crisis
exemption
which
allows
the
unregistered
use
for
15
days.
The
state
notifies
EPA
of
this
action
prior
to
issuing
the
crisis,
and
EPA
performs
a
cursory
review
of
the
use
to
ensure
there
are
no
concerns.
If
any
concerns
are
noted,
EPA
confers
with
the
state
and
under
extreme
cases
may
not
allow
a
crisis
to
be
declared.
If
the
state
follows
up
the
crisis
with,
or
has
already
submitted,
an
emergency
exemption
request,
the
use
may
continue
under
the
crisis
until
EPA
has
made
a
decision
on
the
request.
EPA
must
establish
the
appropriate
time­
limited
tolerance(
s)
required
by
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
for
any
pesticide
uses
under
emergency
exemptions,
including
crisis
exemptions.

There
are
no
forms
associated
with
either
the
application
for,
or
summary
reports
on,
an
emergency
exemption.

Over
the
past
three
years
(
2001,
2002,
2003),
EPA
has
received
an
average
of
approximately
500
section
18
requests.
In
general,
emergency
exemption
applications
are
submitted
so
that
an
unregistered
pesticide
may
be
used
to
control
problematic
and
unexpected
insects,
weeds
or
plant
diseases
for
commercial
agriculture.
Producers
of
minor
crops
are
especially
reliant
on
the
emergency
exemption
program.
Less
frequently,
emergency
exemption
applications
are
submitted
in
order
to
combat
pests
which
pose
a
threat
to
public
health.
The
section
18
emergency
exemption
program
is
also
supporting
certain
public
health
and
agricultural
homeland
security
initiatives.

In
2003,
EPA
initiated
a
limited
pilot
program
whereby
states
and
the
Agency
are
jointly
evaluating
two
process
improvements
relative
to:
(
1)
repeat
section
18
requests
and
(
2)
the
methodology
for
substantiating
economically
significant
pest
losses.
This
pilot
program
is
still
underway
and
tracks
an
ongoing
rule­
making
initiative
in
this
area.

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
EPA
is
the
principal
federal
agency
charged
with
the
regulation
of
pesticides.
This
regulation
is
conducted
under
FIFRA,
which
requires
all
uses
of
pesticide
products
to
be
registered
with
EPA
prior
to
marketing.
Due
to
unpredictable
circumstances
such
as
climatic
conditions,
development
of
resistance,
or
importation
of
pests,
situations
arise
that
call
for
the
immediate
need
for
a
pesticide
for
a
use
for
which
it
is
not
registered,
and
for
which
there
is
insufficient
time
to
obtain
registration.
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2004
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The
FFDCA
requires
that
EPA
establish
tolerances,
or
maximum
legal
limits
for
all
pesticide
residues
in
food,
including
those
resulting
from
Section
18
emergency
uses.
Tolerances
established
for
emergency
exemptions
are
time­
limited
to
correspond
to
the
use
season
or
multiple
use
seasons.
In
establishing
tolerances,
EPA
must
make
the
finding
that
there
is
"
reasonable
certainty
that
no
harm"
will
result
to
human
health
from
aggregate
and
cumulative
exposure
to
the
pesticide,
as
required
by
the
health­
based
standard.
Establishment
of
these
tolerances,
with
their
expiration
dates,
is
published
in
the
Federal
Register.

Section
18
of
FIFRA
states
in
part
that,
"
The
Administrator
may,
at
[
his/
her]
discretion,
exempt
any
federal
or
state
agency
from
any
provision
of
this
Act
if
[
s]
he
determines
that
emergency
conditions
exist
that
require
such
exemption"
(
see
attachment
A).
Under
this
provision,
EPA
may
temporarily
authorize
federal
or
state
agencies
to
allow
use
of
pesticide
products
under
emergency
conditions.
Detailed
regulations
regarding
the
procedures
for
emergency
exemptions
are
contained
in
Title
40
Code
of
Federal
Regulations
(
CFR)
Part
166
(
see
attachment
B).
Attachment
E
provides
a
specific
section­
by­
section
listing
of
each
of
the
requirements
under
40
CFR
166
that
are
related
to
this
ICR.

2(
b)
Practical
Utility/
Users
of
the
Data
EPA
uses
the
information
collected
to
carry
out
its
statutory
responsibilities
under
FIFRA.
The
Agency
uses
the
submitted
information
to
appraise
the
validity
of
the
emergency
situation
and
proposed
measures
to
combat
the
pest(
s).
The
summary
report
is
essential
to
weighing
the
emergency
nature
of
the
situation
as
well
as
the
effectiveness
and
risks
of
the
treatment
program.

3.
NON
DUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non
duplication.

This
information
collection
activity
is
unique
and
is
administered
by
EPA
pursuant
to
FIFRA.
The
possibility
of
duplication
does
not
exist.

3(
b)
Public
Notice
and
Opportunity
to
Comment
In
preparing
to
renew
this
ICR,
EPA
will
publish
a
notice
in
the
Federal
Register
which
will
provide
a
60­
day
public
notice
and
comment
period.
The
Agency
will
consider
any
comments
received
in
response
to
that
notice
before
submitting
the
ICR
to
OMB.

3(
c)
Consultations.

Consultation
and/
or
dialogue
between
states
and
the
Agency
during
the
submission
and
review
of
an
application
are
frequent
and
ongoing.
Questions
or
consultations
pertaining
to
a
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2004
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particular
submission
are
addressed
in
meetings
or
telephone
conversations
with
the
applicant
and
do
not
necessarily
occur
at
specified
intervals.
In
addition
to
communications
regarding
specific
exemption
requests,
Agency
staff
frequently
participate
in
stakeholder
meetings
with
state
and
federal
pesticide
regulatory
officials
and
the
grower
community.
These
communications
permit
an
exchange
of
problems
and
questions
on
the
program
in
general
and
other
relevant
issues.
For
example,
OPP
staff
members
participate
extensively
in
meetings
with
the
State
FIFRA
Research
and
Evaluation
Group
(
SFIREG),
which
meets
several
times
a
year.

In
addition,
during
preparation
of
this
ICR
renewal,
EPA
staff
will
contact
representatives
from
a
cross­
section
of
respondents
by
e­
mail
and
telephone
to
seek
feedback
on
the
burden
estimates
in
the
ICR,
the
clarity
of
instructions
provided,
the
feasibility
of
reporting
the
data
by
electronic
means,
and
other
questions
pertaining
to
the
requirements
of
the
program.

3(
d)
Effects
of
Less
Frequent
Collection.

As
discussed
above,
there
is
no
collection
schedule
for
this
information
collection
activity,
per
se.
State
and
federal
agencies
initiate
the
information
collection
activity
when
they
prepare
an
emergency
exemption
application
for
submission
to
EPA.
Consequently,
there
is
no
way
EPA
can
reduce
the
frequency
of
the
collection
and
maintain
its
responsibilities
under
FIFRA
section
18.

3(
e)
General
Guidelines.

EPA
requires
the
states
to
maintain
records
of
the
first
food
use
of
a
pesticide
under
an
emergency
exemption
for
two
years
following
the
date
of
expiration.
Generally,
an
applicant
for
an
emergency
exemption
is
not
required
to
maintain
data
beyond
the
date
that
the
summary
report
has
been
received
by
the
Agency.
Therefore,
the
OMB
guidelines
codified
in
5
CFR
1320.6
indicate
that
data,
other
than
health,
medical,
or
tax
records,
need
not
be
retained
for
more
than
three
years
and
will
not
be
exceeded
in
this
program.

3(
f)
Confidentiality
Although
the
EPA
urges
the
submitter
to
minimize
the
amount
of
claimed
Confidential
Business
Information
(
CBI),
all
data
and/
or
information
brought
to
the
Agency
in
conjunction
with
this
rule
may
be
claimed
as
trade
secret,
or
commercial
or
financial
information
and
will
be
protected
from
disclosure
by
the
EPA
under
FIFRA
section
10
and
the
associated
regulation
as
contained
in
40
CFR
Part
2,
Subpart
B.
In
general,
EPA
works
to
make
information
relative
to
section
18
decisions
and
supporting
data
easily
available
to
the
public
(
e.
g.
web
site
postings
of
program
information).
Growers
and
industry
stakeholders
need
to
be
made
aware
of
section
18
exemptions.
Thus,
as
a
rule,
claims
of
confidentiality
are
not
made
on
emergency
exemption
applications.
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2004
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Data
submitted
to
the
Agency
are
handled
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
(
CBI)
Security
Manual
which
provides
procedures
for
protecting
information
claimed
as
confidential
in
accordance
with
FIFRA
section
10.
If
the
information
is
not
protected
under
FIFRA
section
10,
and
it
is
not
otherwise
protected
from
release
under
the
Freedom
of
Information
Act,
EPA
is
obligated
to
make
it
available
to
members
of
the
public
upon
request.

3(
g)
Sensitive
Questions
No
information
of
a
sensitive
or
private
nature
is
requested
in
conjunction
with
this
collection
activity.
Further,
this
information
collection
activity
complies
with
the
provisions
of
the
Privacy
Act
of
1974
and
OMB
circular
A­
108.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAICS
Codes
Respondents
affected
by
the
collection
activities
under
this
ICR
are
federal
and
state
agencies
which
regulate
pesticides
or
pesticide
products.
The
North
American
Industrial
Classification
System
(
NAICS)
code
assigned
to
the
states
and
federal
government
agencies
responding
to
this
information
is
9641,
regulation
of
agricultural
marketing
and
commodities.

4(
b)
Information
Requested
To
apply
for
an
exemption,
an
application
must
be
submitted
in
writing
by
the
head
of
a
federal
or
state
agency,
the
Governor
of
the
state
involved,
or
their
official
designee.
If
a
designee
has
been
delegated
authority
to
request
exemptions,
written
authorization
of
such
delegation
must
accompany
the
request
or
be
on
file
with
the
EPA.

Applications
for
specific,
quarantine,
or
public
health
exemptions
must
contain
the
following
information:

Identity
of
contact
person(
s)
Name
and
telephone
number
of
one
or
more
qualified
experts
who
may
be
contacted
if
questions
arise
concerning
the
application.
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2004
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Description
of
the
pesticide
Description
of
pesticide(
s)
proposed
for
the
use
under
the
exemption.
For
a
federally
registered
pesticide:

$
registration
number
and
name
of
pesticide
product
(
if
a
specific
product
is
requested),
or
formulation(
s)
requested
(
if
a
specific
product
is
not
desired),
and
$
copy
of
any
additional
labeling
proposed
for
the
emergency
exemption.

For
an
unregistered
pesticide
product,
copy
of:

$
Confidential
Statement
of
Formula
(
or
reference
to
one
already
submitted
to
the
Agency),
and
$
Complete
labeling
to
be
used
in
connection
with
proposed
use.

Description
of
the
proposed
use
Application
must
identify
all
of
the
following:

$
sites
to
be
treated,
including
locations
within
the
state,

$
method
of
application,

$
rate
of
application
of
active
ingredient
and
product,

$
total
acreage
or
other
appropriate
unit
proposed
to
be
treated,

$
total
amount
of
pesticide
proposed
to
be
used
(
active
ingredient
and
product),
and
$
all
applicable
restrictions
and
requirements
concerning
proposed
use
and
qualifications
of
applicators
using
the
pesticide.

Alternative
methods
of
control
Detailed
explanation
of
why
the
pesticide(
s),
currently
registered
for
the
particular
use
proposed
in
the
application,
is
not
available
in
adequate
supplies
and/
or
effective
to
the
degree
needed
to
control
the
emergency.
If
the
applicant
states
that
an
available
registered
pesticide
is
ineffective
for
the
given
situation,
the
statement
must
be
supported
by
field
data
that
demonstrate
this,
or
if
such
data
are
unavailable,
statements
by
qualified
agricultural
experts,
extension
personnel,
university
personnel
or
other
persons
similarly
qualified
in
the
field
of
pest
control.
In
addition,
a
detailed
explanation
must
be
provided
of
why
alternative
practices,
if
available,
either
would
not
provide
adequate
control
or
would
not
be
economically
or
environmentally
feasible.

Effectiveness
of
proposed
use
Application
must
contain
data,
discussion
of
field
trials,
and
other
evidence
that
provide
the
basis
for
the
conclusion
that
the
proposed
pesticide
treatment
will
be
effective
in
dealing
with
the
emergency.
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30,
2004
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Discussion
of
residues
for
food
uses
If
proposed
use
is
expected
to
result
in
residues
of
the
pesticide
in
or
on
food
or
feed,
application
must
list
the
food
likely
to
contain
such
residues
and
must
contain
an
estimate
of
the
maximum
amount
of
the
residue
likely
to
result
from
the
proposed
use,
together
with
the
information
on
which
such
estimates
are
based.

Discussion
of
risk
information
Potential
risks
to
human
health,
endangered
species,
beneficial
organisms,
and
the
environment
expected
to
result
from
the
proposed
use,
together
with
references
to
data
and
other
supporting
information.

Coordination
with
other
affected
state
or
federal
agencies.
If
the
proposed
pesticide
use
is
likely
to
be
of
concern
to
other
federal
or
state
agencies,
application
must
indicate
that
such
agencies
have
been
contacted
prior
to
submission
of
the
application,
and
any
comments
received
from
such
agencies
must
be
submitted
to
EPA.

Notification
of
registrant
or
basic
manufacturer.
Statement
that
the
registrants
of
all
pesticide
products
proposed
for
use
or,
if
appropriate,
the
basic
manufacturer,
have
been
notified
that
a
request
has
been
made
of
EPA
for
the
use
of
the
pesticide
under
a
specific,
quarantine,
or
public
health
exemption.

Description
of
proposed
enforcement
program.
Explanation
of
the
authority
of
the
applicant
or
related
state
or
federal
agency
for
ensuring
that
use
of
the
pesticide
under
the
proposed
exemption
would
comply
with
any
special
requirements
imposed
by
EPA
and
a
description
of
the
program
and
procedures
for
assuring
such
compliance.

Progress
toward
registration.
Prior
to
submitting
an
application
for
a
repeat
specific
or
public
health
exemption,
the
federal
or
state
agency
must
contact
the
registrant
regarding
the
progress
being
made
toward
registration
of
the
proposed
use
and
include
this
information
in
the
section
18
application.
This
information
must
also
include
a
summary
of
study
deficiencies
and
data
gaps,
and
registrant's
timetable
for
completing
requirements
for
registration.

In
addition,
the
following
information
must
be
provided:
July
30,
2004
Page
8
of
20
For
a
specific
exemption
All
of
the
following,
as
appropriate,
must
be
provided
concerning
the
nature
of
the
emergency:

$
scientific
and
common
name
of
the
pest
or
pest
complex;

$
events
that
brought
about
the
emergency
condition;

$
anticipated
risks
to
endangered
or
threatened
species,
beneficial
organisms,
or
the
environment
that
would
be
remediated
by
the
proposed
use
of
the
pesticide;
and
$
anticipated
significant
economic
loss
that
would
occur
without
the
use
of
the
requested
registered
pesticide,
together
with
data
and
other
supporting
information,
that
addresses
the
historical
net
and
gross
revenues
for
the
site,
the
estimated
net
and
gross
revenues
for
the
site
without
use
of
the
proposed
pesticide,
and
the
estimated
net
and
gross
revenues
for
the
site
with
use
of
the
proposed
pesticide.

For
a
quarantine
exemption
A
quarantine
exemption
may
be
authorized
in
an
emergency
condition
to
control
the
introduction
or
spread
of
any
pest
new
to
and
therefore
known
to
be
widely
prevalent
or
distributed
within
and
throughout
the
United
States
and
its
territories.
The
application
for
the
quarantine
exemption
must
include
the
following
information:

$
scientific
and
common
name
of
the
pest
or
pest
complex;

$
origin
of
the
introduced
pest
and
the
means
of
its
introduction
and
spread
into
the
area,
if
known.

$
economic
impact
of
controlling
versus
not
controlling
the
pest
via
the
proposed
pesticide
treatment.

For
a
public
health
exemption
$
Scientific
and
common
name
of
pest
or
pest
complex;
if
the
pest
is
a
vector,
a
description
of
the
disease
it
is
expected
to
transmit;
°
magnitude
of
the
health
problems
that
are
expected
to
occur
without
the
pesticide
use;
and
°
availability
of
medical
treatment
for
the
health
problem.
July
30,
2004
Page
9
of
20
For
a
crisis
exemption,
only
the
following
information
must
be
provided:
The
state
or
federal
agency
issuing
the
crisis
exemption
must
provide
notification
to
EPA
at
least
36
hours
before
and
no
later
than
24
hours
after
utilization
of
the
crisis
provisions.
The
state
or
federal
agency
issuing
the
crisis
exemption
must
notify
the
registrant(
s)
or,
if
appropriate,
the
basic
manufacturer(
s)
of
the
pesticide(
s)
being
used
under
the
crisis
exemption
at
the
same
time
notice
is
given
to
EPA.
The
notice
must
include:

$
name
of
active
ingredient
authorized
for
the
crisis
use,
including
the
common
name
and
the
Chemical
Abstracts
Service
(
CAS)
number;

$
crop
or
site
on
which
the
pesticide
is
to
be
used;

$
use
pattern
(
method,
number,
and
rate
of
applications);

$
dates
that
applications
started
or
will
begin
and
end;

$
an
estimate
of
the
level
or
residues
of
the
pesticide
expected
to
result
from
use
under
the
crisis
exemption
(
for
food
crops);
and
$
discussion
of
the
emergency
situation
and
any
other
pertinent
information
available
at
the
time,
including
why
time
was
insufficient
to
request
a
specific
or
quarantine
exemption,
and
intentions
with
respect
to
requesting
a
specific
exemption
for
this
use.

4(
c)
Data
Items,
Including
Record
keeping
requirements
To
comply
with
the
reporting
and
record
keeping
requirements
for
specific,
quarantine,
and
public
health
exemptions,
the
exemption
holder
must
provide
the
following
data
items
to
EPA:

Unexpected
adverse
effects
information
Any
unexpected
adverse
effects
resulting
from
the
use
of
a
pesticide
under
a
specific,
quarantine,
or
public
health
exemption
must
be
reported
immediately
to
the
Agency.
July
30,
2004
Page
10
of
20
Final
reports
A
report
summarizing
the
results
of
pesticide
use
under
a
specific,
quarantine,
and
public
health
exemption
must
be
submitted
to
EPA
within
six
months
of
the
expiration
of
the
exemption
unless
otherwise
specified
by
the
Agency.
The
information
in
this
report
must
include
the
following:

$
total
acreage,
amount
of
commodity
or
other
unit
treated
and
the
total
quantity
of
the
pesticide
used;

$
discussion
of
the
effectiveness
of
the
pesticide
in
dealing
with
the
emergency
condition;

$
description
of
any
unexpected
adverse
effects
that
resulted
from
the
use
of
the
pesticide
under
the
exemption;

$
results
of
any
monitoring
required
and/
or
carried
out
under
the
exemption;

$
any
enforcement
actions
taken
in
connection
with
the
exemption;

$
method(
s)
of
disposition
of
food
crops,
if
required
to
be
destroyed;
and
$
any
other
information
requested
by
the
Administrator.

Records
Records
for
all
treatments
involving
the
first
food
use
of
a
pesticide
will
be
maintained
by
the
state
or
federal
agency
for
which
an
emergency
exemption
was
granted
for
a
minimum
of
two
years
following
the
date
of
expiration
of
the
exemption.
On
request
by
EPA,
these
records
must
be
made
available
to
the
Administrator.
Records
must
include
the
following;

$
locations
where
the
pesticide
was
applied;

$
dates
of
application
(
range);
and
$
total
quantity
of
the
pesticide
used.
July
30,
2004
Page
11
of
20
4(
d)
Applicant
Activities
To
obtain
a
permit
to
use
an
unregistered
pesticide
product
under
emergency
conditions,
an
applicant
must
petition
EPA
in
writing
by
a
letter
or
telegram
containing
the
data
items
listed
above
and
commit
to
the
submission
of
the
summary
report
on
the
action
taken
to
meet
the
emergency.
Section
18
Emergency
Exemption
applications
are
submitted
to
the
Minor
Use,
Inerts
and
Emergency
Response
Branch
(
Mail
Code
7505C),
Registration
Division,
Office
of
Pesticide
Programs,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue.,
N.
W.,
Washington,
D.
C.,
20460.

In
order
to
participate
in
the
program,
the
applicant
must:


Read
germane
FIFRA
requirements
and
CFR
regulations.


Process,
compile,
and
review
the
requested
data
for
accuracy
and
appropriateness.


Generate
application
correspondence
and
follow­
up
summary
report.


Store,
file
or
maintain
the
information.

5.
THE
INFORMATION
COLLECTED
­­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
On
October
25,
2000,
EPA
published
a
Final
Rule
in
the
Federal
Register
(
65
FR
64125)
entitled
"
Time­
Limited
Tolerances
for
Pesticide
Emergency
Exemptions"
(
see
attachment
D)
This
rule,
which
became
effective
on
November
24,
2000,
set
into
place
a
process
to
ensure
timely
decisions
on
any
tolerance­
related
issue
in
response
to
a
request
for
an
emergency
exemption
for
a
pesticide
to
be
used
on
food
or
feed.
Under
this
rule,
time­
limited
tolerance
petitions
related
to
FIFRA
Section
18
are
evaluated
on
a
case­
by­
case
basis
to
determine
if
adequate
reliable
data
are
available
to
make
the
required
safety
finding
mandated
under
FFDCA
Section
408
(
see
attachment
C)
and
FQPA.

Applications
for
emergency
exemptions
are
submitted
by
U.
S.
states
and
territories,
and
federal
agencies
at
their
discretion.
These
applications
are
received
by
the
Office
of
Pesticide
Programs
(
OPP),
Registration
Division,
Minor
Use,
Inerts,
and
Emergency
Response
Branch,
where
they
are
reviewed
for
completeness.
The
application
package
is
routed
to
scientists
and
economists
within
OPP
to
determine
whether
the
proposed
emergency
exemption
is
warranted,
that
there
is
"
reasonable
certainty
of
no
harm"
to
human
health
resulting
from
aggregate
and
cumulative
exposure,
and
that
it
presents
no
undue
hazard
to
humans
or
the
environment.
Once
the
determinations
are
made,
the
applicant
is
notified
in
writing
.
The
tolerance
is
published
in
the
Federal
Register.
EPA
has
established
a
50­
day
response
turnaround
as
a
self­
imposed
guideline
for
review
of
emergency
exemption
requests,
providing
the
application
package
is
July
30,
2004
Page
12
of
20
complete.
The
Agency's
average
response
turnaround
time
for
complete
applications
has
been
less
than
50
days
for
the
past
three
years.

The
Agency
conducts
the
following
activities
when
responding
to
an
emergency
exemption
application
under
FIFRA
section
18:


Route
the
application/
report
to
appropriate
scientists
and
economists
for
review.


Review
information
submitted
for
scientific
accuracy.


Perform
a
biological,
ecological,
and
economic
analysis
and
a
multi­
disciplinary
risk
assessment
of
the
requested
use,
then
forward
a
regulatory
recommendation
on
the
proposed
exemption
along
with
a
draft
notification
to
EPA
management.


Make
the
FQPA
finding
of
"
reasonable
certainty
of
no
harm"
to
human
health
resulting
from
aggregate
and
cumulative
exposure.
Establish
a
time­
limited
tolerance
if
required.


Conduct
an
assessment
of
the
progress
toward
registration
for
the
requested
use.


OPP
Director
(
or
designee)
makes
final
decision.


Notify
applicant
of
decision.


Prepare
and
publish
Federal
Register
Notice
(
for
applicable
food
use
requests).


Record
electronic
data
in
Agency's
data
system
and
file
hard
copy
in
Branch
files.

5(
b)
Collection
Methodology
and
Management
When
applications
for
emergency
exemptions
are
received
by
EPA,
they
are
jacketed
and
filed
by
the
name
of
the
state,
territory
or
federal
agency,
by
the
date,
and
by
the
number
of
the
submission
for
that
entity.
The
application
is
tracked
in
EPA's
data
system
as
an
active
pending
request
through
the
determination
process,
and
subsequent
receipt
of
the
summary
report,
after
which
the
exemption
becomes
a
historical
file
and
the
regulatory
action
is
closed.

5(
c)
Small
Entity
Flexibility
No
flexibility
for
small
entities
exists
under
this
information
collection
activity.
Section
18
of
FIFRA
applies
directly
only
to
State,
territorial,
and
federal
government
agencies;
it
does
not
apply
to
other
entities.
States
are
not
"
small
entities"
as
defined
by
the
Regulatory
Flexibility
Act.

5(
d)
Collection
Schedule
There
is
no
collection
schedule
associated
with
this
information
collection
activity,
per
se.
This
information
collection
activity
is
initiated
by
the
States
or
by
certain
federal
agencies
when
they
determine
that
they
are
confronted
with
an
emergency
situation
and
subsequently
submit
an
emergency
exemption
application
to
EPA
under
FIFRA
Section
18.
July
30,
2004
Page
13
of
20
6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a)
Estimating
Respondent
Burden
The
total
annual
response
burden
associated
with
submitting
an
application
for
Emergency
Exemption
(
Section
18s)
is
estimated
to
be
49,500
hours
per
year
or
148,500
hours
over
the
next
three
years
based
upon
the
average
number
of
Emergency
Exemption
requests
received
over
the
last
three
years.
The
number
of
applications
received
by
EPA
has
decreased
from
an
average
of
600
per
year
for
the
years
1998
­
2000
to
an
average
of
about
500
per
year
for
the
years
ranging
from
2001
­
2003.
The
important
trends
seen
in
the
applications
received
in
the
past
three
years
are:


the
successful
transition
of
a
high
number
of
minor
crop
section
18
programs
to
full
registrations
and
tolerances
under
section
3
labels;


in
spite
of
the
focus
on
eliminating
long­
running
section
18
applications
there
are
continuing
pest
management
challenges
that
are
national
in
scope
that
trigger
emergency
exemption
requests
(
e.
g.
the
use
of
coumaphos
and
thymol
in
bee
hives
to
control
varroa
mite;


expanding
reliance
on
section
18
programs
to
plan
for
and
respond
to
public
health
and
agricultural
homeland
security
threats
­
such
as
anthrax
decontamination,
foot
and
mouth
disease,
and
soybean
rust;


States
have
started
requesting
Section
18
emergency
exemptions
for
more
than
one
chemical
to
deal
with
some
pest
problems;

The
Agency
expects
that
some
of
these
factors
will
persist
and
subsequently
expects
to
receive
an
average
of
500
to
550
applications
annually
for
the
next
three
years.

6(
b)
Estimating
Respondent
Costs
The
total
cost
for
all
respondents
associated
with
submitting
an
application
for
Emergency
Exemption
is
estimated
to
be
$
2,683,000
annually
or
$
8,049,000
over
the
next
three
years.
The
hourly
wage
rates
used
for
this
renewal
ICR
were
updated
and
increased
from
the
estimated
rates
of
$
60,
$
50,
$
39
for
management,
technical,
and
clerical
labor
resources
(
respectively)
in
the
ICR
previously
approved
by
OMB
in
2000
to
$
65,
$
54,
and
$
42
for
the
respective
classes
of
labor
resources.
The
wage
rates
for
the
petitioner/
state
worker
were
adjusted
for
present
year
using
the
figures
from
the
previous
ICR
and
a
multiplier
factor
suggested
by
wage
increases
for
state
government
workers
from
data
developed
by
the
Bureau
of
Labor
Statistics.
The
wage
rates
are
"
fully
loaded."
This
includes
the
nominal
wage,
benefits,
and
overhead.
The
Applicant
hourly
rates
of
the
previous
ICR
were
based
on
the
US
Bureau
of
Labor
Statistics'
1989
Wage
Rates
of
State
Government
Workers,
adjusted
for
inflation
using
the
Consumer
Price
Index.
July
30,
2004
Page
14
of
20
ANNUAL
APPLICANT
BURDEN/
COST
ESTIMATES
Burden
Hours
(
per
request)
Total
Collection
Activity
Wages
per
hour:
Mgmt.
Tech.
Cler.
Hours
Costs
($)
$
65
$
54
$
42
Read
FIFRA
and
FQPA
requirements
and
CFR
regulations.
4
4
0
8
$
476
Process,
compile,
and
review
the
requested
data
for
accuracy
and
appropriateness.
0
74
0
74
$
3,996
Generate
application
correspondence
and
follow­
up
summary
report.
0
15
0
15
$
810
Store,
file
or
maintain
the
information.
0
0
2
2
$
84
0
$
0
0
$
0
TOTAL
4
93
2
99
$
5,366
ANNUAL
BURDEN:
99
Total
Hours
x
500
applicants
=
49,500
Hours
ANNUAL
COSTS:

(
a)
Management:
4
hours
x
$
65
x
500
applicants
=
$
130,000
(
b)
Technical:
93
hours
x
$
54
x
500
applicants
=
$
2,511,000
(
c)
Clerical:
2
hours
x
$
42
x
500
applicants
=
$
42,000
Total:
$
2,683,000
6(
c)
Estimating
Agency
Burden
and
Cost
July
30,
2004
Page
15
of
20
The
estimated
cost
to
the
Federal
government
of
the
Emergency
Exemption
program
consists
of
two
components.
The
first
is
the
number
of
hours
and
costs
incurred
by
the
Agency
to
complete
a
standard
application.
The
second
component
is
the
costs
for
other
elements
that
do
not
fall
under
the
category
of
collection
activities,
but
are
required
as
part
of
the
program.

The
total
Agency
burden
in
terms
of
hours
is
estimated
to
be
54,000
hours
annually.
The
total
annual
Agency
cost
for
processing
Emergency
Exemption
Requests
is
estimated
to
be
$
3,705,500.
The
labor
rates
used
to
calculate
Agency
burden
for
this
ICR
are
based
on
the
previous
ICR
and
have
been
adjusted
to
2003
using
the
general
annual
salary
percent
increases
from
the
Office
of
Personnel
Management
salary
tables
for
federal
employees.
These
rates
are
rounded
to
the
nearest
dollar
and
include
benefits
and
overhead
costs.
ANNUAL
AGENCY
BURDEN/
COST
ESTIMATES
ANNUAL
AGENCY
BURDEN/
COST
ESTIMATES
ANNUAL
AGENCY
BURDEN/
COST
ESTIMATES
Collection
Activity
Wages
per
hour:
Mgmt.
Tech.
Cler.
Hours
Costs
($)
$
92
$
67
$
32
Read
and
review
the
applications
or
reports
for
completeness.
0
8
1
9
$
568
Route
the
application/
report
to
appropriate
scientists
and
economists
for
review.
0
4
0
4
$
268
Review
information
submitted
for
scientific
accuracy.
0
16
0
16
$
1,072
Perform:
­
a
biological,
ecological,
and
economic
analysis
­
a
multi­
disciplinary
risk
assessment
­
make
FQPA
finds
of
"
reasonable
certain
of
no
harm"
to
human
health
­
forward
a
regulatory
recommendation
on
the
proposed
exemption
along
with
a
draft
notification
to
the
requestor.
2
40
1
43
$
2,896
Reach
final
decision,
prepare
Final
Rule
Notice
and
notify
applicant.
5
28
1
34
$
2,368
July
30,
2004
Page
16
of
20
Record
electronic
data
in
Agency's
Pesticide
Regulatory
Action
Tracking
System
(
PRATS),
record
receipt
in
branch
tracking
system
and
file
hard
copy
in
Branch
files.
0
1
1
2
$
99
TOTAL
7
97
4
108
$
7,271
ANNUAL
BURDEN:
108
Total
Hours
x
500
applicants
=
54,000
Hours
ANNUAL
COSTS:

(
a)
Management:
7
hours
x
$
92
x
500
applicants
=
$
322,000
(
b)
Technical:
97
hours
x
$
67
x
500
applicants
=
$
3,249,500
(
c)
Clerical:
4
hours
x
$
32
x
500
applicants
=
$
64,000
Total:
$
3,635,500
OTHER
ANNUAL
AGENCY
COSTS:

Federal
Register
publications:
average
of
5
Notices
of
Receipt
@
average
$
2,000
each
$
10,000
average
of
25
Tolerances
established
@
average
$
2,000
each
$
50,000
average
of
3
Mass
Tolerance
extension
documents
@
average
$
2,000
each
$
6,000
average
of
2
notices
per
year
per
40
C.
F.
R.
166.30
@
average
of
$
2,000
each
$
4,000
Total
$
$
70,000
ANNUAL
AGENCY
COST
BURDEN
TOTAL:
$
3,635,500
+$
70,000
=
$
3,705,500
6(
d)
Bottom
Line
Burden
Hours
and
Cost
Tables
MASTER
TABLE
July
30,
2004
Page
17
of
20
Total
Annual
Applicant
Burden/
Cost
Estimates
49,500
$
2,683,000
Annual
Agency
Burden/
Cost
Estimates
54,000
$
3,705,500
July
30,
2004
Page
18
of
20
6(
e)
Reasons
for
Change
in
Burden.

The
overall
respondent
burden
has
decreased
due
to
the
drop
in
the
overall
number
of
section
18
emergency
exemption
applications
annually
from
600
for
the
period
1998
­
2000
to
approximately
500
for
the
period
2001
­
2003.
This
trend
is
attributable
to
the
Agency's
focus
and
priority
on
making
registration
decisions
for
repeated
section
18
uses
quickly.
For
instance
in
2003
registration
decisions
for
120
uses
negated
the
need
for
applicants
to
submit
repeat
section
18
requests.
In
2002,
56
repeat
section
18
uses
were
negated
by
registration
decisions.
The
amendments
to
FIFRA
under
the
Pesticide
Registration
Improvement
Act
are
likely
to
reinforce
this
trend.

6(
f)
Burden
Statement
The
annual
respondent
burden
for
collection
of
information
associated
with
the
rule
is
estimated
to
average
99
hours
per
application.
According
to
the
Paperwork
Reduction
Act,
"
burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection,
it
is
the
time
reading
the
regulations,
planning
the
necessary
data
collection
activities,
conducting
tests,
analyzing
data,
generating
reports
and
completing
other
required
paperwork,
and
storing,
filing,
and
maintaining
the
data.
The
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
this
information
collection
appear
at
the
beginning
and
the
end
of
this
document.
In
addition
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPP­
2004­
0186,
which
is
available
for
public
viewing
at
the
OPP
Docket
in
the
Public
Information
and
Records
Integrity
Branch,
Rm.
119,
Crystal
Mall
#
2,
1801
South
Bell
St..,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305­
5805.

An
electronic
version
of
the
public
docket
for
this
ICR
renewal
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
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
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPP­
2004­
0186
and
OMB
Control
No.
2070­
0032
in
any
correspondence.
July
30,
2004
Page
19
of
20
ATTACHMENTS
TO
THE
SUPPORTING
STATEMENT
Attachment
A
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
18
­
available
electronically
at
http://
www.
epa.
gov/
pesticides/
fifra.
htm
Attachment
B
40
CFR
Part
166
­
available
electronically
at
http://
frwebgate4.
access.
gpo.
gov/
cgibin
waisgate.
cgi?
WAISdocID=
45973327890+
27+
0+
0&
WAISaction=
retrieve
Attachment
C
FFDCA
section
408
­
available
electronically
at
http://
www4.
law.
cornell.
edu/
uscode/
21/
ch9.
html
Attachment
D
Final
Rule;
Time­
Limited
Tolerances
for
Pesticide
Emergency
Exemptions
(
65
FR
65125)
­
available
electronically
at
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
October/
Day­
25/
p27405.
pdf
Attachment
E
Display
Related
to
OMB
Control
#
2070­
0032
­
Listings
of
Related
Regulations
in
40
CFR
9.1
­
available
as
part
of
the
electronic
file
for
this
supporting
statement.
July
30,
2004
Display
Related
to
OMB
Control
#
2070­
0032
­
Listings
of
Related
Regulations
in
40
CFR
9.1
As
of
May
10,
1993,
the
OMB
approval
numbers
for
EPA
regulations
in
Chapter
I
of
Title
40
of
the
Code
of
Federal
Regulations
(
CFR)
appear
in
a
listing
in
40
CFR
9.1
(
58
FR
27472).
This
listing
fulfills
the
display
requirements
in
section
3507(
f)
of
the
Paperwork
Reduction
Act
(
PRA)
for
EPA
regulations.
The
listing
at
40
CFR
9.1
displays
this
OMB
Control
number
for
the
following
regulations:

Program
Title
40
CFR
citation
Exemption
of
Federal
and
State
Agencies
for
Use
of
Pesticides
Under
Emergency
Conditions
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
166.20
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
166.32
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
166.43
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
166.50
