Document ID: EPA-HQ-OPP-2004-0038-0041
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-01-27T05:00Z

October
29,
2004
Page
1
of
91
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.:
0596.08
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)
(
Attachment
A)
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.

Under
Section
18
of
FIFRA,
EPA
can
allow
State
and
Federal
agencies
to
permit
the
unregistered
use
of
a
pesticide
in
a
specific
geographic
area
for
a
limited
time
if
emergency
pest
conditions
exist.
Usually,
this
arises
when
growers
and
others
encounter
a
pest
problem
on
a
site
for
which
there
is
either
no
registered
pesticide
available,
or
for
which
there
is
a
registered
pesticide
that
would
be
effective
but
is
not
yet
approved
for
use
on
that
particular
site.
Section
18
also
allows
EPA
to
grant
unregistered
pesticide
use
exemptions
for
public
health
and
quarantine
reasons.
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
a
state's
department
of
agriculture)
and
request
that
the
state
agency
apply
to
EPA
for
a
Section
18
emergency
exemption
for
a
particular
use.
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
EPA
determines
that
conditions
exist
which
require
an
exemption
and
October
29,
2004
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2
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91
the
risks
are
acceptable,
EPA
typically
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.

In
unpredictable
emergency
situations
when
insufficient
time
for
a
formal
section
18
application
and
review
process
is
available
to
address
the
problem,
a
state
agency
may
issue
a
crisis
exemption
which
allows
for
the
use
of
an
unregistered
pesticide
for
no
longer
than
15
days,
unless
an
application
for
the
specific
exemption
request
has
been
submitted
to
EPA.

When
feasible,
the
state
issuing
the
crisis
exemption
must
notify
EPA
at
least
36
hours
in
advance
of
using
the
crisis
provisions
or
no
later
than
24
hours
after
the
state
decision
to
avail
self
of
a
crisis
exemption.
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,
see
Attachment
C)
for
any
pesticide
uses
under
emergency
exemptions,
including
crisis
exemptions.

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
use
in
the
United
States.
Due
to
unpredictable
circumstances
such
as
unexpected
changes
in
climatic
conditions,
development
of
pest
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.
October
29,
2004
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3
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91
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.
These
tolerances,
and
their
expiration
dates,
are
established
by
a
final
rulemaking
published
in
the
Federal
Register.
The
procedural
regulation
for
establishing
such
tolerances
is
codified
at
40
CFR
176
and
can
be
found
in
Attachment
D
of
this
ICR.

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
40
CFR
Part
166
(
see
Attachment
B).
Attachment
I
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
application
and
follow­
up
reporting
is
essential
to
weighing
the
emergency
nature
of
the
situation
as
well
as
the
effectiveness,
risks
of
the
treatment
program,
and
comparing
the
cost
impacts,
if
any,
of
the
estimated
net
and
gross
revenues
for
the
period
before
the
unregistered
use
and
after
the
unregistered
use
of
the
pesticide
at
the
site.

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
3(
b)
Public
Notice
and
Opportunity
to
Comment
In
preparing
to
renew
this
ICR,
EPA
published
a
notice
in
the
Federal
Register
which
provided
a
60­
day
public
notice
and
comment
period
on
the
draft
ICR.
(
see
69
FR
52664,
August
27,
2004).
EPA
received
one
comment
in
response
to
this
notice.
A
copy
of
the
comment
and
EPA's
response
can
be
found
in
Attachment
E
of
this
ICR.
October
29,
2004
Page
4
of
91
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
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.

For
this
renewal,
EPA
consulted
with
three
state
entities
that
might
have
a
specific
interest
in
this
ICR
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.
EPA
staff
contacted
the
representatives
listed
in
Attachment
F
by
telephone
and
e­
mail
and
asked
them
for
feedback
on
the
burden
and
cost
estimates
in
the
ICR.
The
solicitation
for
consultation
included
state
Department
of
Agriculture
representatives.
Comments
received
as
part
of
the
consultation
process
are
listed
in
Attachment
G.
No
changes
to
the
burden
hours
or
cost
were
made
to
the
ICR
as
a
result
of
any
of
the
comments
received.

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
October
29,
2004
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5
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91
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.

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
eligible
to
be
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.
October
29,
2004
Page
6
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91
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:

$
EPA
Form
No.
8570­
4
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.

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.
October
29,
2004
Page
7
of
91
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:

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.
October
29,
2004
Page
8
of
91
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.

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
EPA
Form
No.
8570­
4,
Confidential
Statement
of
Formula,
(
see
Attachment
H)
is
the
single
form
associated
with
either
the
application
for,
or
summary
reports
on,
an
emergency
exemption.
To
comply
with
the
reporting
and
record
keeping
requirements
for
specific,
October
29,
2004
Page
9
of
91
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.

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.
October
29,
2004
Page
10
of
91
4(
d)
Applicant
Activities
To
obtain
a
permit
to
use
an
unregistered
pesticide
product
under
emergency
conditions,
an
applicant
must
petition
EPA
in
writing
and
provide
information
addressing
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"
(
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
(
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
complete.
The
Agency's
average
response
turnaround
time
for
complete
applications
has
been
less
than
50
days
for
the
past
three
years.
October
29,
2004
Page
11
of
91
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.

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
October
29,
2004
Page
12
of
91
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
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.
October
29,
2004
Page
13
of
91
State
Government
"
Applicant"
Burden/
Cost
Estimates
COLLECTION
ACTIVITY
Burden
Hours
(
per
application)
Total
Mgmt.
$
65/
hr
Tech.
$
54/
hr
Cler.
$
42/
hr
Hours
Costs
($)

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/
maintain/
submit
information
0
0
2
2
84
Totals
4
93
2
99
5,366
ANNUAL
BURDEN:
99
Total
Hours
x
500
applications
=
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
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.
October
29,
2004
Page
14
of
91
Annual
Agency
Burden/
Cost
Estimates
COLLECTION
ACTIVITY
Burden
Hours
(
per
application)
Total
Mgmt.
$
92/
hr
Tech.
$
67/
hr
Cler.
$
32/
hr
Hours
Costs
($)

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
FFDCA
section
408(
b)(
2)(
A)(
ii)
safety
findings
­
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
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
Totals
7
97
4
108
7,271
ANNUAL
BURDEN:
108
Total
Hours
x
500
applications
=
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=
$
3,645,500
October
29,
2004
Page
15
of
91
OTHER
ANNUAL
AGENCY
COSTS:
Average
annual
frequency
of
related
Federal
Register
publications
(
avg.
cost
=
$
2000):

Type
of
Federal
Register
Document
Number
per
Year
Cost
Notice:
Receipt
of
Application
for
Emergency
Exemption;
Solicitation
of
Public
Comment
5
$
10,000
Final
Rule:
Pesticide
Tolerance
for
Emergency
Exemptions
25
$
50,000
Final
Rule:
Extension
of
Tolerance(
s)
for
Emergency
Exemptions
3
$
6,000
Notice:
Pesticide
Emergency
Exemptions;
Agency
Decisions
and
State
and
Federal
Agency
Crisis
Declarations
2
$
4,000
Total
35
$
70,000
OVERALL
TOTAL
ANNUAL
AGENCY
COST
BURDEN:
$
3,635,500
+
$
70,000
=
$
3,705,500
6(
d)
Bottom
Line
Burden
Hours
and
Cost
Tables
Total
Burden
and
Cost
Estimates
TOTAL
ESTIMATES
Hours
Costs
State
Government
Applicants
­
Annual
49,500
$
2,683,000
Agency
­
Annual
54,000
$
3,705,500
6(
e)
Reasons
for
Change
in
Burden.

The
decrease
in
burden
associated
with
this
ICR
(
from
59,400
to
49,500
hours)
reflects
an
adjustment.
The
annual
burden
has
decreased
by
9,900
hours
due
to
the
drop
in
the
overall
number
of
section
18
emergency
exemption
applications
filed
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
October
29,
2004
Page
16
of
91
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
0252
and
OMB
Control
No.
2070­
0032
in
any
correspondence.

ATTACHMENTS
TO
THE
SUPPORTING
STATEMENT
ATTACHMENT
A:
7
U.
S.
C.
136p
­
FIFRA
Section
18
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement
and
can
also
be
accessed
in
PDF
via
the
Internet
at
http://
www.
epa.
gov/
opp00001/
regulating/
fifra.
pdf.

ATTACHMENT
B:
40
CFR
Part
166
­
Exemption
of
Federal
and
State
Agencies
for
Use
of
Pesticides
under
Emergency
Conditions
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement
and
can
also
be
accessed
via
the
Internet
at
http://
www.
epa.
gov/
epacfr40/
chapt­
I.
info/
chi­
toc.
htm
ATTACHMENT
C:
21
U.
S.
C
346a
­
FFDCA
section
408
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement.
October
29,
2004
Page
17
of
91
ATTACHMENT
D:
65
FR
65125
­
Final
Rule;
Time­
Limited
Tolerances
for
Pesticide
Emergency
Exemptions
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement
and
can
also
be
accessed
via
the
Internet
at
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
October/
Day­
25/
p27405.
pdf
ATTACHMENT
E:
Public
Comment
Received
Regarding
the
Proposed
Renewal
ICR
and
EPA
Response
to
Comment
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement.

ATTACHMENT
F:
Consultant
Contacts
for
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
&
Questions
Asked
EPA
During
Consultations
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement.

ATTACHMENT
G:
Comments
Received
in
the
Consultation
Process
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement.

ATTACHMENT
H:
EPA
Form
No.
8570­
4
­
Confidential
Statement
of
Formula
­
This
attachment
is
only
available
electronically
as
a
PDF
file.
You
may
easily
access
the
file
in
EDOCKET,
the
electronic
version
of
the
public
docket
http://
www.
epa.
gov/
edocket.
Once
in
the
system,
select
"
Quick
Search"
under
the
heading
"
Go
Directly
to
EDOCKET"
in
the
left
navigational
menu.
Next,
search
by
Docket
and
enter
in
the
following
docket
ID
number
in
the
field
provided:
"
OPP­
2004­
0252".
Then,
search
the
docket
index
for
the
document
by
title.
If
you
have
any
difficulties,
please
contact
the
technical
person
listed
in
the
Federal
Register
notice
announcing
the
submission
of
this
ICR
to
OMB
for
review
and
approval.
The
form
is
also
available
electronically
via
the
Internet
at
http://
www.
epa.
gov/
opprd001/
forms/
8570­
4.
pdf
ATTACHMENT
I:
Display
Related
to
OMB
Control
#
2070­
0032
­
Listings
of
Related
Regulations
in
40
CFR
9.1
­
This
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement.
October
29,
2004
Page
18
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
A
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
18
7
U.
S.
C.
136p
October
29,
2004
Page
19
of
91
ATTACHMENT
A
SEC.
18.
[
7
U.
S.
C.
136p]
EXEMPTION
OF
FEDERAL
AND
STATE
AGENCIES.
The
Administrator
may,
at
the
Administrator's
discretion,
exempt
any
Federal
or
State
agency
from
any
provision
of
this
Act
if
the
Administrator
determines
that
emergency
conditions
exist
which
require
such
exemption.
The
Administrator,
in
determining
whether
or
not
such
emergency
conditions
exist,
shall
consult
with
the
Secretary
of
Agriculture
and
the
Governor
of
any
State
concerned
if
they
request
such
determination.
October
29,
2004
Page
20
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
B
40
CFR
Part
166
October
29,
2004
Page
21
of
91
ATTACHMENT
B
Code
of
Federal
Regulations
Title
40
B
Protection
of
the
Environment
Part
166
B
Exemption
of
Federal
and
State
Agencies
for
Use
of
Pesticides
under
Emergency
Conditions
Section
Contents
Subpart
A
C
General
Provisions
§
166.1
Purpose
and
organization.
§
166.2
Types
of
exemptions.
§
166.3
Definitions.
§
166.7
User
notification;
advertising.

Subpart
B
C
Specific,
Quarantine,
and
Public
Health
Exemptions
§
166.20
Application
for
a
specific,
quarantine,
or
public
health
exemption.
§
166.22
Consultation
with
the
Secretary
of
Agriculture
and
Governors
of
the
States.
§
166.24
Public
notice
of
receipt
of
application
and
opportunity
for
public
comment.
§
166.25
Agency
review.
§
166.28
Duration
of
exemption.
§
166.30
Notice
of
Agency
decision.
§
166.32
Reporting
and
recordkeeping
requirements
for
specific,
quarantine,
and
public
health
exemptions.
§
166.34
EPA
review
of
information
obtained
in
connection
with
emergency
exemptions.
§
166.35
Revocation
or
modification
of
exemptions.

Subpart
C
C
Crisis
Exemptions
§
166.40
Authorization.
§
166.41
Limitations.
§
166.43
Notice
to
EPA
and
registrants
or
basic
manufacturers.
§
166.45
Duration
of
crisis
exemption.
§
166.47
Notification
of
FDA,
USDA,
and
State
health
officials.
§
166.49
Public
notice
of
crisis
exemptions.
§
166.50
Reporting
and
recordkeeping
requirements
for
crisis
exemption.
§
166.53
EPA
review
of
crisis
exemption
and
revocation
of
authority.

AUTHORITY:
7
U.
S.
C.
136B136y.
SOURCE:
51
FR
1902,
Jan.
15,
1986,
unless
otherwise
noted.

Subpart
A
C
General
Provisions
October
29,
2004
Page
22
of
91
§
166.1
Purpose
and
organization.

(
a)
Purpose
and
scope.
Section
18
of
the
Act
authorizes
the
Administrator
to
exempt
State
and
Federal
agencies
from
any
provision
of
the
Act,
if
he
determines
that
emergency
conditions
exist
which
require
an
exemption.
The
regulations
in
this
part
establish
procedures
whereby
the
Administrator
may
exempt
a
Federal
or
State
agency
from
the
provisions
of
the
Act
which
regulate
the
manner
in
which
a
pesticide
is
made
available
for
use
or
is
used.

(
b)
Organization.
(
1)
The
provisions
in
subpart
A
of
this
part
describe
the
four
types
of
emergency
exemptions
authorized
by
the
Agency
and
define
terms
used
in
this
part.

(
2)
Subpart
B
of
this
part
establishes
procedures
and
criteria
for
specific,
quarantine,
and
public
health
exemptions.

(
3)
Subpart
C
of
this
part
establishes
procedures
and
criteria
for
crisis
exemptions.

§
166.2
Types
of
exemptions.

There
are
four
types
of
emergency
exemptions
which
may
be
authorized:
specific,
quarantine,
public
health,
and
crisis
exemptions.

(
a)
Specific
exemption.
A
specific
exemption
may
be
authorized
in
an
emergency
condition
to
avert:

(
1)
A
significant
economic
loss;
or
(
2)
A
significant
risk
to:

(
i)
Endangered
species,

(
ii)
Threatened
species,

(
iii)
Beneficial
organisms,
or
(
iv)
The
environment.

(
b)
Quarantine
exemption.
A
quarantine
exemption
may
be
authorized
in
an
emergency
condition
to
control
the
introduction
or
spread
of
any
pest
new
to
or
not
theretofore
known
to
be
widely
prevalent
or
distributed
within
and
throughout
the
United
States
and
its
territories.

(
c)
Public
health
exemption.
A
public
health
exemption
may
be
authorized
in
an
emergency
condition
to
control
a
pest
that
will
cause
a
significant
risk
to
human
health.

(
d)
Crisis
exemption.
A
crisis
exemption
may
be
utilized
in
an
emergency
condition
when
the
time
October
29,
2004
Page
23
of
91
from
discovery
of
the
emergency
to
the
time
when
the
pesticide
use
is
needed
is
insufficient
to
allow
for
the
authorization
of
a
specific,
quarantine,
or
public
health
exemption.

§
166.3
Definitions.

Terms
used
in
this
part
shall
have
the
meanings
established
by
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act.
In
addition,
as
used
in
this
part,
the
following
terms
shall
also
apply:

(
a)
The
term
the
Act
means
the
Federal,
Insecticide,
Fungicide,
and
Rodenticide
Act,
as
amended,
7
U.
S.
C.
136
et
seq.

(
b)
The
terms
the
Agency
and
EPA
mean
the
U.
S.
Environmental
Protection
Agency.

(
c)
The
term
beneficial
organism
means
any
pollinating
insect,
or
any
pest
predator,
parasite,
pathogen
or
other
biological
control
agent
which
functions
naturally
or
as
part
of
an
integrated
pest
management
program
to
control
another
pest.

(
d)
The
term
emergency
condition
means
an
urgent,
non­
routine
situation
that
requires
the
use
of
a
pesticide(
s)
and
shall
be
deemed
to
exist
when:

(
1)
No
effective
pesticides
are
available
under
the
Act
that
have
labeled
uses
registered
for
control
of
the
pest
under
the
conditions
of
the
emergency;
and
(
2)
No
economically
or
environmentally
feasible
alternative
practices
which
provide
adequate
control
are
available;
and
(
3)
The
situation:

(
i)
Involves
the
introduction
or
dissemination
of
a
pest
new
to
or
not
theretofore
known
to
be
widely
prevalent
or
distributed
within
or
throughout
the
United
States
and
its
territories;
or
(
ii)
Will
present
significant
risks
to
human
health;
or
(
iii)
Will
present
significant
risks
to
threatened
or
endangered
species,
beneficial
organisms,
or
the
environment;
or
(
iv)
Will
cause
significant
economic
loss
due
to:

(
A)
An
outbreak
or
an
expected
outbreak
of
a
pest;
or
(
B)
A
change
in
plant
growth
or
development
caused
by
unusual
environmental
conditions
where
such
change
can
be
rectified
by
the
use
of
a
pesticide(
s).
October
29,
2004
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24
of
91
(
e)
The
term
first
food
use
refers
to
the
use
of
a
pesticide
on
a
food
or
in
a
manner
which
otherwise
would
be
expected
to
result
in
residues
in
a
food,
if
no
permanent
tolerance,
exemption
from
the
requirement
of
a
tolerance,
or
food
additive
regulation
for
residues
of
the
pesticide
on
any
food
has
been
established
for
the
pesticide
under
section
408
(
d)
or
(
e)
or
409
of
the
Federal
Food,
Drug,
and
Cosmetic
Act.

(
f)
The
term
food
means
any
article
used
for
food
or
drink
for
man
or
animals.

(
g)
The
term
new
chemical
means
an
active
ingredient
not
contained
in
any
currently
registered
pesticide.

(
h)
The
term
significant
economic
loss
means
that,
under
the
emergency
conditions:
for
a
productive
activity,
the
profitability
would
be
substantially
below
the
expected
profitability
for
that
activity;
or,
for
other
types
of
activities,
where
profits
cannot
be
calculated,
the
value
of
public
or
private
fixed
assets
would
be
substantially
below
the
expected
value
for
those
assets.
Only
losses
caused
by
the
emergency
conditions,
specific
to
the
impacted
site,
and
specific
to
the
geographic
area
affected
by
the
emergency
conditions
are
included.
The
contribution
of
obvious
mismanagement
to
the
loss
will
not
be
considered
in
determining
loss.
In
evaluating
the
significant
of
an
economic
loss
for
productive
activities,
the
Agency
will
consider
whether
the
expected
reduction
in
profitability
exceeds
what
would
be
expected
as
a
result
of
normal
fluctuations
over
a
number
of
years,
and
whether
the
loss
would
affect
the
long­
term
financial
viability
expected
from
the
productive
activity.
In
evaluating
the
significance
of
an
economic
loss
for
situations
other
than
productive
activities,
the
Agency
will
consider
reasonable
measures
of
expected
loss.

(
i)
The
term
Special
Review
refers
to
any
interim
administrative
review
of
the
risks
and
benefits
of
the
use
of
a
pesticide
conducted
pursuant
to
the
provisions
of
EPA's
Rebuttable
Presumption
Against
Registration
rules,
40
CFR
162.11(
a),
or
any
subsequent
version
of
those
rules.

(
j)
The
term
unreasonable
adverse
effects
on
the
environment
means
any
unreasonable
risk
to
man
or
the
environment,
taking
into
account
the
economic,
social,
and
environmental
costs
and
benefits
of
the
use
of
any
pesticide.

§
166.7
User
notification;
advertising.

(
a)
A
State
or
Federal
agency
that
obtains
an
exemption
may
notify
eligible
users
of
the
availability
of
the
exempted
pesticide(
s)
through
user
groups,
retail
dealers,
and
other
means.
Notification
may
include
distributing
copies
of
the
section
18
approval
letter,
labeling,
or
other
information
to
eligible
persons.

(
b)
As
set
forth
more
fully
in
§
168.22
of
this
chapter,
EPA
interprets
FIFRA
sections
12(
a)(
1)
(
A)
and
(
B)
as
making
it
unlawful
for
any
person
who
distributes,
sells,
offers
for
sale,
holds
for
sale,
ships,
delivers
for
shipment,
or
receives
and
(
having
so
received)
delivers
or
offers
to
deliver
any
pesticide,
to
advertise
the
pesticide
for
any
use
authorized
by
an
emergency
exemption,
except
for
advertisements
that
are
placed
in
media
that
address
only
persons
in
the
geographical
area
to
October
29,
2004
Page
25
of
91
which
the
exemption
applies,
state
the
name
and
address
of
one
or
more
retail
dealers
where
users
may
buy
the
pesticide,
and
contain
a
prominent
notice
of
the
limitations
on
use
under
the
emergency
exemption.
EPA
may
withdraw
an
exemption
if
the
use
of
the
pesticide
covered
by
the
exemption
is
advertised
unlawfully.

[
54
FR
1125,
Jan.
11,
1989]

Subpart
B
C
Specific,
Quarantine,
and
Public
Health
Exemptions
§
166.20
Application
for
a
specific,
quarantine,
or
public
health
exemption.

(
a)
General
information
required
in
an
application
for
a
specific,
quarantine
or
public
health
exemption.
An
application
must
be
submitted
in
writing
by
the
head
of
the
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
Agency.
In
addition,
the
application
must
contain
all
applicable
information
specified
in
paragraphs
(
a)
(
1)
through
(
11)
of
this
section.

(
1)
Identity
of
contact
persons.
(
i)
Unless
otherwise
specified,
the
person
who
submits
the
application
will
be
considered
the
contact
person
for
all
matters
relating
to
administration
of
the
emergency
exemption.

(
ii)
Requests
should
identify
by
name
and
telephone
number
one
or
more
qualified
experts
who
may
be
contacted
in
case
any
questions
arise
concerning
the
application.

(
2)
Description
of
the
pesticide.
The
application
shall
contain
a
description
of
the
pesticide(
s)
proposed
for
use
under
the
exemption.
Such
information
shall
include:

(
i)
For
a
federally
registered
pesticide
product:

(
A)
The
registration
number
and
the
name
of
the
pesticide
product
if
a
specific
product
is
requested;
or
the
formulation(
s)
requested
if
a
specific
product
is
not
desired;
and
(
B)
A
copy
of
any
additional
labeling
proposed
for
the
emergency
exemption;
or
(
ii)
For
any
other
pesticide
products:

(
A)
A
confidential
statement
of
formula
or
reference
to
one
already
submitted
to
the
Agency;
and
(
B)
Complete
labeling
to
be
used
in
connection
with
the
proposed
exemption
use.

(
3)
Description
of
the
proposed
use.
The
application
shall
identify
all
of
the
following:
October
29,
2004
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26
of
91
(
i)
Sites
to
be
treated,
including
their
locations
within
the
State;

(
ii)
The
method
of
application;

(
iii)
The
rate
of
application
in
terms
of
active
ingredient
and
product;

(
iv)
The
total
acreage
or
other
appropriate
unit
proposed
to
be
treated;

(
v)
The
total
amount
of
pesticide
proposed
to
be
used
in
terms
of
both
active
ingredient
and
product;
and
(
vi)
All
applicable
restrictions
and
requirements
concerning
the
proposed
use
and
the
qualifications
of
applicators
using
the
pesticide.

(
4)
Alternative
methods
of
control.
The
application
shall
contain:

(
i)
A
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
which
demonstrate
ineffectiveness
of
registered
pesticides,
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;
and
(
ii)
A
detailed
explanation
of
why
alternative
practices,
if
available,
either
would
not
provide
adequate
control
or
would
not
be
economically
or
environmentally
feasible.

(
5)
Effectiveness
of
proposed
use.
The
application
shall
contain
data,
a
discussion
of
field
trials,
or
other
evidence
which
provide
the
basis
for
the
conclusion
that
the
proposed
pesticide
treatment
will
be
effective
in
dealing
with
the
emergency.

(
6)
Discussion
of
residues
for
food
uses.
If
the
proposed
use
is
expected
to
result
in
residues
of
the
pesticide
in
or
on
food,
the
application
shall
list
the
food
likely
to
contain
such
residues
and
shall
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.

(
7)
Discussion
of
risk
information.
The
application
shall
address
the
potential
risks
to
human
health,
endangered
or
threatened
species,
beneficial
organisms,
and
the
environment
expected
to
result
from
the
proposed
use,
together
with
references
to
data
and
other
supporting
information.

(
8)
Coordination
with
other
affected
State
or
Federal
agencies.
If
the
proposed
use
of
the
pesticide
is
likely
to
be
of
concern
to
other
Federal
or
State
agencies,
the
application
shall
indicate
that
such
agencies
have
been
contacted
prior
to
submission
of
the
application,
and
any
comments
received
from
such
agencies
shall
be
submitted
to
EPA.
October
29,
2004
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27
of
91
(
9)
Notification
of
registrant
or
basic
manufacturer.
The
application
shall
contain
a
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
to
the
Agency
for
use
of
the
pesticide
under
a
specific,
quarantine,
or
public
health
exemption.

(
10)
Description
of
proposed
enforcement
program.
Prior
to
approval,
the
applicant
shall
provide
an
explanation
of
the
authority
of
the
applicant
or
related
State
or
Federal
agencies
for
ensuring
that
use
of
the
pesticide
under
the
proposed
exemption
would
comply
with
any
special
requirements
imposed
by
the
Agency
and
a
description
of
the
program
and
procedures
for
assuring
such
compliance.

(
11)
Repeated
uses.
Applications
for
the
use
of
a
pesticide
at
a
site
for
which
the
applicant
has
previously
been
exempted
under
section
18
shall
contain
an
interim
report
summarizing
the
results
of
the
specific,
quarantine,
or
public
health
exemption
previously
issued,
if
the
application
is
submitted
prior
to
the
time
the
final
report
for
the
previous
exemption
is
due.
The
interim
report
shall
contain
that
information
specified
in
§
166.32
to
the
extent
available
at
the
time
the
application
is
made.

(
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:

(
1)
The
scientific
and
common
name
of
the
pest
or
pest
complex;

(
2)
A
discussion
of
the
events
which
brought
about
the
emergency
condition;

(
3)
A
discussion
of
the
anticipated
risks
to
endangered
or
threatened
species,
beneficial
organisms,
or
the
environment
that
would
be
remedied
by
the
proposed
use
of
the
pesticide;
and
(
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.

(
c)
Information
required
for
a
quarantine
exemption.
An
application
for
a
quarantine
exemption
shall
provide
all
of
the
following
information
concerning
the
nature
of
the
emergency:

(
1)
The
scientific
and
common
name
of
pest;

(
2)
The
origin
of
pest
and
the
means
of
its
introduction
or
spread
if
known;
and
October
29,
2004
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28
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91
(
3)
The
anticipated
impact
of
not
controlling
the
pest.

(
d)
Information
required
for
a
public
health
exemption.
An
application
for
a
public
health
exemption
shall
provide
all
the
following
information
concerning
the
nature
of
the
emergency:

(
1)
The
scientific
and
common
name
of
the
pest
to
be
controlled
and,
if
the
pest
is
a
vector,
a
description
of
the
disease
it
is
expected
to
transmit;

(
2)
A
discussion
of
the
magnitude
of
the
health
problems
which
are
expected
to
occur
without
the
pesticide
use;
and
(
3)
Discussion
of
the
availability
of
medical
treatment
for
the
health
problem.

[
51
FR
1902,
Jan.
15,
1986,
as
amended
at
58
FR
34203,
June
23,
1993]

§
166.22
Consultation
with
the
Secretary
of
Agriculture
and
Governors
of
the
States.

The
Agency,
in
determining
whether
or
not
such
emergency
conditions
exist,
shall
consult
with
the
Secretary
of
Agriculture
and
the
Governor
of
any
State
concerned
if
they
request
such
determination.

§
166.24
Public
notice
of
receipt
of
application
and
opportunity
for
public
comment.

(
a)
Publication
requirement.
The
Administrator
shall
issue
a
notice
of
receipt
in
the
Federal
Register
for
a
specific
quarantine,
or
public
health
exemption
and
request
public
comment
when
any
one
of
the
following
criteria
is
met:

(
1)
The
application
proposes
use
of
a
new
chemical;

(
2)
The
application
proposes
the
first
food
use
of
an
active
ingredient;

(
3)
The
application
proposes
any
use
of
a
pesticide
if
the
pesticide
has
been
subject
to
a
suspension
notice
under
section
6(
c)
of
the
Act;

(
4)
The
application
proposes
use
of
a
pesticide
which:

(
i)
Was
the
subject
of
a
notice
under
section
6(
b)
of
the
Act
and
was
subsequently
cancelled,
and
(
ii)
Is
intended
for
a
use
that
poses
a
risk
similar
to
the
risk
posed
by
any
use
of
the
pesticide
which
was
the
subject
of
the
notice
under
section
6(
b);

(
5)
The
application
proposes
use
of
a
pesticide
which:

(
i)
Contains
an
active
ingredient
which
is
or
has
been
the
subject
of
a
Special
Review,
and
October
29,
2004
Page
29
of
91
(
ii)
Is
intended
for
a
use
that
could
pose
a
risk
similar
to
the
risk
posed
by
any
use
of
the
pesticide
which
is
or
has
been
the
subject
of
the
Special
Review;

(
6)
The
application
proposes
use
of
a
pesticide
for
a
specific
or
public
health
exemption,
if:

(
i)
An
emergency
exemption
has
been
requested
or
granted
for
that
use
in
any
3
previous
years,
and
(
ii)
A
complete
application
for
registration
of
that
use
and/
or
a
petition
for
tolerance
for
residues
in
or
on
the
commodity
has
not
been
submitted
to
the
Agency;
or
(
7)
The
Administrator
determines
that
publication
of
notice
is
appropriate.

(
b)
Contents.
The
notice
of
receipt
of
an
application
for
an
emergency
exemption
shall
contain
the
following
information:

(
1)
The
name
of
the
applicant;

(
2)
The
name
of
the
active
ingredient
requested
for
use,
including,
if
available,
the
common
name
and
the
Chemical
Abstracts
Service
(
CAS)
number;

(
3)
The
total
amount
of
product
or
active
ingredient
proposed
for
use;

(
4)
The
geographical
location
where
treatment
is
proposed;

(
5)
The
proposed
number
of
acres
or
other
appropriate
units
proposed
to
be
treated;

(
6)
A
summary
of
the
applicant's
description
of
the
emergency
conditions
including
the
pest
and
the
site
or
crop
to
be
treated;

(
7)
A
description
of
the
major
conditions
of
use
of
the
pesticide
as
proposed
by
the
applicant;

(
8)
If
the
pesticide
proposed
for
use
meets
the
criteria
of
paragraph
(
a)
(
3),
(
4),
or
(
5)
of
this
section,
an
identification
of
the
types
of
risks
that
were
the
basis
for
EPA's
regulatory
action;
and
(
9)
The
name,
telephone
number,
and
address
of
a
person
in
the
Agency
who
can
provide
further
information.

(
c)
Length
of
comment
period.
Normally,
a
notice
of
receipt
shall
give
the
public
15
days
in
which
to
file
comments
on
the
application.
The
Administrator
may
shorten
or
eliminate
the
comment
period
if
he
determines
that
the
time
available
for
a
decision
on
the
application
requires
it
and
shall
state
reasons
for
such
action
in
a
notice
in
the
Federal
Register.
The
Administrator
may
extend
the
comment
period
if
additional
time
for
comment
is
requested
and
such
an
extension
would
not
interfere
with
a
timely
decision
on
the
application.
October
29,
2004
Page
30
of
91
§
166.25
Agency
review.

(
a)
General.
The
Agency
will
review
all
requests
as
expeditiously
as
possible,
making
every
attempt
to
respond
to
requests
prior
to
the
time
when
the
proposed
use
is
needed.
The
Agency
will
review
the
application
and
other
available
data
necessary
to
make
a
determination
with
respect
to
all
of
the
following:

(
1)
Whether
an
emergency
condition
exists
or
will
exist;

(
2)
The
level
of
residues
in
or
on
all
food
resulting
from
the
proposed
use;

(
3)
The
anticipated
benefits
to
be
derived
from
the
proposed
use;
and
(
4)
The
potential
risks
to
the
human
health,
endangered
or
threatened
species,
beneficial
organisms,
and
the
environment
from
the
proposed
use.

(
b)
Criteria
for
approval.
The
Administrator
may
authorize
a
specific,
public
health,
or
quarantine
exemption,
based
on
the
information
available
to
the
Agency,
after:

(
1)
He
determines
that:

(
i)
An
emergency
condition
exists;

(
ii)
The
use
of
the
pesticide
under
the
exemption
will
not
cause
unreasonable
adverse
effects
on
the
environment;

(
iii)
Registration
of
the
pesticide
use
for
which
the
exemption
is
requested
has
not
been
suspended
under
section
6(
c)
of
the
Act
or
cancelled
following
a
notice
under
section
6(
b)
of
the
Act,
unless
the
use
is
authorized
in
accordance
with
the
provisions
of
§
§
164.130
through
164.133
of
this
chapter;

(
2)
Giving
due
consideration
to:

(
i)
Whether
the
pesticide
is
reasonably
likely
to
be
used
in
compliance
with
the
requirements
imposed
by
the
Agency
under
the
exemption;
and
(
ii)
The
progress
which
has
been
made
toward
registration
of
the
proposed
use,
if
a
repeated
specific
or
public
health
exemption
is
sought.
It
shall
be
presumed
that
if
a
complete
application
for
registration
of
a
use,
which
has
been
under
a
specific
or
public
health
exemption
for
any
3
previous
years,
has
not
been
submitted,
reasonable
progress
towards
registration
has
not
been
made.

§
166.28
Duration
of
exemption.
October
29,
2004
Page
31
of
91
(
a)
Specific
or
public
health
exemptions.
EPA
shall
allow
use
of
a
pesticide
under
a
specific
or
public
health
exemption
for
as
long
a
period
as
is
reasonably
expected
to
be
necessary
but
in
no
case
for
longer
than
1
year.

(
b)
Quarantine
exemption.
EPA
shall
allow
use
of
a
pesticide
under
a
quarantine
exemption
for
as
long
a
period
as
is
deemed
necessary
but
in
no
case
for
longer
than
3
years.
Quarantine
exemptions
may
be
renewed.
Interim
reports
containing
the
information
specified
in
§
166.32(
b)
to
the
extent
available
shall
be
filed
annually.

§
166.30
Notice
of
Agency
decision.

(
a)
Notification
of
applicants.
The
Agency
shall
notify
an
applicant
of
its
decision
to
approve
or
deny
an
application
request
for
an
emergency
exemption
in
a
timely
manner.

(
1)
Incomplete
applications.
The
Agency
may
discontinue
the
processing
of
any
application
which
does
not
contain
all
of
the
information
required
by
§
166.20
until
such
time
the
additional
information
is
submitted
by
the
applicant.

(
2)
Complete
applicationsC(
i)
Denials.
The
Agency
shall
provide
the
specific
reasons
and
rationale
for
denying
the
exemption
request.
If
the
denial
is
based
on
a
specific
information
gap,
the
decision
shall
be
reconsidered
in
a
timely
manner
when
the
information
gap
is
filled.

(
ii)
Approvals.
The
Agency
shall
provide
the
specific
terms
and
conditions
under
which
the
exempted
pesticide
may
be
used.

(
b)
Notification
of
FDA,
USDA,
and
State
health
officials.
If
a
use
authorized
under
a
specific,
quarantine,
or
public
health
exemption
will
result
in
residues
of
the
pesticide
chemical
in
or
on
food,
the
Agency
shall
notify
the
Food
and
Drug
Administration,
U.
S.
Department
of
Health
and
Human
Services,
and
the
Food
Safety
and
Inspection
Service,
U.
S.
Department
of
Agriculture,
as
appropriate,
of
the
level
of
residues
expected
to
result.
Additionally,
the
Agency
shall
ensure
that
State
health
and
food
officials,
as
appropriate,
are
also
provided
with
the
information
specified
in
this
paragraph.

(
c)
Federal
Register
publication.
(
1)
At
least
quarterly,
the
Administrator
shall
issue
a
notice
in
the
Federal
Register
announcing
all
approvals
of
specific,
quarantine,
and
public
health
exemptions.
The
notice
shall
contain
all
of
the
following:

(
i)
The
name
of
the
applicant;

(
ii)
The
pesticide
authorized
for
use;

(
iii)
The
crop
or
site
to
be
treated;
and
(
iv)
The
name,
address,
and
telephone
number
of
a
person
in
the
Agency
who
can
provide
further
October
29,
2004
Page
32
of
91
information.

(
2)
In
addition,
if
EPA
has
issued
a
Notice
of
Receipt
of
an
application
for
an
exemption,
it
will
issue
a
notice
of
its
final
decision
and
the
reasons
for
that
decision.

§
166.32
Reporting
and
recordkeeping
requirements
for
specific,
quarantine,
and
public
health
exemptions.

(
a)
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
immediately
reported
to
the
Agency.

(
b)
Final
reports.
A
report
summarizing
the
results
of
pesticide
use
under
a
specific,
quarantine,
and
public
health
exemption
must
be
submitted
to
the
Agency
within
6
months
from
the
expiration
of
the
exemption
unless
otherwise
specified
by
the
Agency.
The
information
in
this
report
shall
include
all
of
the
following:

(
1)
Total
acreage,
amount
of
commodity
or
other
unit
treated
and
the
total
quantity
of
the
pesticide
used;

(
2)
A
discussion
of
the
effectiveness
of
the
pesticide
in
dealing
with
the
emergency
condition;

(
3)
A
description
of
any
unexpected
adverse
effects
which
resulted
from
use
of
the
pesticide
under
the
exemption;

(
4)
The
results
of
any
monitoring
required
and/
or
carried
out
under
the
exemption;

(
5)
A
discussion
of
any
enforcement
actions
taken
in
connection
with
the
exemption;

(
6)
Method(
s)
of
disposition
of
a
food
crop,
if
required
to
be
destroyed
under
an
exemption;
and
(
7)
Any
other
information
requested
by
the
Administrator.

(
c)
Records.
Records
for
all
treatments
involving
the
first
food
use
of
a
pesticide
will
be
maintained
by
the
agency
to
which
the
emergency
exemption
was
granted
for
a
minimum
of
2
years
following
the
date
of
expiration
of
the
exemption.
On
request
by
the
Agency
these
records
shall
be
made
available
to
the
Administrator.
Records
will
include
all
of
the
following:

(
1)
Locations
where
the
pesticide
was
applied;

(
2)
Dates
of
application
(
range);
and
(
3)
Total
quantity
of
the
pesticide
used.
October
29,
2004
Page
33
of
91
[
51
FR
1902,
Jan.
15,
1986,
as
amended
at
58
FR
34203,
June
23,
1993]

§
166.34
EPA
review
of
information
obtained
in
connection
with
emergency
exemptions.

EPA
shall
review
information
submitted
in
connection
with
emergency
exemptions
and,
when
applicable,
use
it
in
connection
with
other
regulatory
decisions
under
the
Act.

§
166.35
Revocation
or
modification
of
exemptions.

(
a)
Grounds.
The
Administrator
may
revoke
or
modify
the
terms
or
conditions
of
a
specific,
quarantine,
or
public
health
exemption
if
he
determines
one
of
the
following:

(
1)
An
emergency
no
longer
exists;

(
2)
Use
of
the
pesticide
under
the
exemption
may
cause
unreasonable
adverse
effects
on
the
environment;

(
3)
The
pesticide
authorized
under
the
exemption
is
not
effective
at
controlling
the
pest
or
conditions
causing
the
emergency;
or
(
4)
The
terms
and
conditions
established
by
the
exemption
and
these
regulations
are
not
being
complied
with.

(
b)
Implementation.
The
revocation
or
modification
becomes
effective
as
soon
as
the
Administrator
notifies
the
State
or
Federal
agency
which
submitted
the
application.
Upon
notification,
the
applicant
is
required
immediately
to
take
all
necessary
steps
to
assure
that
further
use
complies
with
the
terms
and
conditions
of
any
modification
or,
if
the
exemption
has
been
revoked,
to
stop
further
use.

Subpart
C
C
Crisis
Exemptions
§
166.40
Authorization.

The
head
of
a
Federal
or
State
agency,
the
Governor
of
a
State,
or
their
official
designee,
may
issue
a
crisis
exemption
in
situations
involving
an
unpredictable
emergency
situation
when:

(
a)
An
emergency
condition
exists;
and
(
b)
The
time
element
with
respect
to
the
application
of
the
pesticide
is
critical,
and
there
is
not
sufficient
time
either
to
request
a
specific,
quarantine,
or
public
health
exemption
or,
if
such
a
request
has
been
submitted,
for
EPA
to
complete
review
of
the
request.

§
166.41
Limitations.
October
29,
2004
Page
34
of
91
The
crisis
provisions
may
not
be
utilized
to
authorize
a
pesticide
use
if
any
of
the
following
has
occurred:

(
a)
EPA
has
informed
the
head
of
the
Federal
or
State
agency,
the
Governor,
or
their
official
designee,
not
to
issue
such
an
exemption;

(
b)
The
pesticide
use
has
been
suspended
under
section
6(
c)
of
the
Act;

(
c)
The
pesticide
use
has
been
cancelled
following
a
notice
issued
under
section
6(
b)
of
the
Act;

(
d)
The
pesticide
contains
a
new
chemical;
or
(
e)
The
application
proposes
the
first
food
use
of
a
pesticide.

§
166.43
Notice
to
EPA
and
registrants
or
basic
manufacturers.

(
a)
Timing
of
notice.
(
1)
When
feasible,
the
State
or
Federal
Agency
issuing
the
crisis
exemption
must
notify
the
Administrator
at
least
36
hours
in
advance
of
utilization
of
the
crisis
provisions.
In
no
case
shall
notice
be
given
to
the
Agency
later
than
24
hours
after
the
decision
to
avail
itself
of
a
crisis
exemption.

(
2)
The
State
or
Federal
agency
issuing
the
crisis
exemption
shall
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
or
as
soon
thereafter
as
possible.

(
b)
Contents
of
notice.
Information
required
to
be
provided
in
notices
shall
include
all
of
the
following:

(
1)
The
name
of
the
active
ingredient
authorized
for
use,
including,
if
available,
the
common
name
and
the
Chemical
Abstracts
Service
(
CAS)
number;

(
2)
The
site
on
which
the
pesticide
is
to
be
used
or
is
being
used;

(
3)
The
use
pattern;

(
4)
The
date
on
which
the
pesticide
use
is
to
begin
or
the
date
on
which
use
of
the
pesticide
began;

(
5)
An
estimate
of
the
level
of
residues
of
the
pesticide
expected
to
result
from
use
under
the
crisis
exemption;
and
(
6)
Any
other
pertinent
information
available
at
the
time.

[
51
FR
1902,
Jan.
15,
1986,
as
amended
at
58
FR
34203,
June
23,
1993]
October
29,
2004
Page
35
of
91
§
166.45
Duration
of
crisis
exemption.

A
crisis
exemption
may
be
authorized
for:

(
a)
Only
as
long
as
is
necessary
to
control
the
pest
or
conditions
causing
the
emergency;
and
(
b)
No
longer
than
15
days,
unless
an
application
requesting
a
specific,
quarantine,
or
public
health
exemption
for
this
use
has
been
submitted
to
the
Agency.

§
166.47
Notification
of
FDA,
USDA,
and
State
health
officials.

If
a
use
authorized
under
a
crisis
exemption
will
result
in
residues
of
the
pesticide
chemical
in
or
on
food,
the
Agency
will
notify
the
authorizing
agency,
the
Food
and
Drug
Administration,
U.
S.
Department
of
Health
and
Human
Services
and
the
Food
Safety
and
Inspection
Service,
U.
S.
Department
of
Agriculture,
as
appropriate,
of
the
level
of
residues
expected
to
result
and
whether
such
residues
pose
an
unacceptable
risk
to
public
health.
This
notice
shall
be
provided
as
soon
as
the
Agency
makes
its
determination.
Additionally,
the
Agency
will
ensure
that
State
health
and
food
officials,
as
appropriate,
are
also
provided
with
this
information.

§
166.49
Public
notice
of
crisis
exemptions.

(
a)
Periodic
notices.
At
least
quarterly,
the
Administrator
shall
issue
a
notice
in
the
Federal
Register
announcing
issuance
of
crisis
exemptions.
The
notice
shall
contain
all
of
the
following:

(
1)
The
name
of
the
State
or
Federal
agency
using
a
crisis
exemption;

(
2)
The
name
of
the
active
ingredient
authorized
for
use,
including,
if
available,
the
common
name
and
the
Chemical
Abstracts
Service
(
CAS)
number;

(
3)
The
site
to
be
treated;

(
4)
The
name,
telephone
number,
and
address
of
a
person
in
the
Agency
who
can
provide
further
information;
and
(
5)
Whether
a
specific,
quarantine,
or
public
health
exemption
has
been
requested.

(
b)
Annual
reports.
Annually,
the
Agency
shall
issue
a
notice
in
the
Federal
Register
that
shall
summarize:

(
1)
The
number
of
crisis
exemptions
declared;
and
(
2)
The
number
of
crisis
exemptions
revoked.

§
166.50
Reporting
and
recordkeeping
requirements
for
crisis
exemption.
October
29,
2004
Page
36
of
91
(
a)
Adverse
effects
information.
Any
adverse
effects
resulting
from
the
use
of
a
pesticide
under
a
crisis
exemption
must
be
immediately
reported
to
the
Agency.

(
b)
Final
reports.
(
1)
A
report
summarizing
the
results
of
treatment
under
a
crisis
exemption
will
be
required
to
be
submitted
to
the
Agency
within
3
months
following
the
last
date
of
treatment.
If
a
specific,
quarantine,
or
public
health
exemption
has
been
approved
while
the
crisis
exemption
is
in
effect,
however,
the
crisis
exemption
report
may
be
incorporated
into
the
specific,
quarantine,
or
public
health
exemption
final
report
required
under
§
166.32(
b)
and
submitted
at
the
time
it
is
due.

(
2)
Information
to
be
included
in
the
crisis
exemption
report
includes
the
same
information
as
required
in
§
166.32(
b)
and
an
explanation
as
to
why
there
was
a
need
to
utilize
the
crisis
provisions.

(
c)
Records.
Records
will
be
maintained
for
a
minimum
of
2
years
following
the
date
of
expiration
of
the
exemption.
On
request
by
the
Agency,
these
records
shall
be
made
available
to
the
Administrator.
Records
will
include
all
of
the
following:

(
1)
Location
where
the
pesticide
was
applied;

(
2)
Dates
of
application
(
range);
and
(
3)
Total
quantity
of
the
pesticide
used.

[
51
FR
1902,
Jan.
15,
1986,
as
amended
at
58
FR
34203,
June
23,
1993]

§
166.53
EPA
review
of
crisis
exemption
and
revocation
of
authority.

(
a)
Review.
When
a
crisis
exemption
is
about
to
be
or
has
already
been
declared
by
a
State
or
Federal
agency,
EPA
will
undertake
an
expedited
review
of
the
pesticide
to
determine
if
use
of
the
pesticide
may
result
in
such
unreasonable
health
or
environmental
risks
that
the
crisis
authority
should
not
be
exercised
or
the
crisis
exemption
should
be
revoked.

(
b)
RevocationC(
1)
Individual
crisis
exemptions.
A
crisis
exemption
for
the
use
of
a
specific
pesticide
may
be
revoked
if
the
Administrator
determines
that:

(
i)
There
are
insufficient
data
to
determine
the
risks
posed
from
the
use;

(
ii)
Such
action
is
necessary
to
protect
man
or
the
environment;
or
(
iii)
The
State
or
Federal
agency
is
not
complying
with
the
requirements
of
this
subpart
C.

(
2)
State
or
Federal
agency
authority.
The
Administrator
may
revoke
the
authority
of
a
State
or
Federal
agency
to
issue
crisis
exemptions
for
any
pesticide
if
he
determines
that:
October
29,
2004
Page
37
of
91
(
i)
Such
action
is
necessary
to
protect
man
or
the
environment;
or
(
ii)
The
State
or
Federal
agency
is
not
complying
with
the
requirements
of
this
subpart
C.

(
c)
Reason
for
revocation.
The
Agency
shall
provide
the
specific
reasons
for
revoking
an
agency's
authority
to
issue
a
crisis
exemption
and
for
revoking
an
issued
crisis
exemption.
October
29,
2004
Page
38
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
C
FFDCA
Section
408
October
29,
2004
Page
39
of
91
ATTACHMENT
C
SEC.
346a.
C
TOLERANCES
AND
EXEMPTIONS
FOR
PESTICIDE
CHEMICAL
RESIDUES
(
a)
REQUIREMENT
FOR
TOLERANCE
OR
EXEMPTION
(
1)
GENERAL
RULE.
C
Except
as
provided
in
paragraph
(
2)
or
(
3),
any
pesticide
chemical
residue
in
or
on
a
food
shall
be
deemed
unsafe
for
the
purpose
of
section
342(
a)(
2)(
B)
of
this
title
unlessC
(
A)
a
tolerance
for
such
pesticide
chemical
residue
in
or
on
such
food
is
in
effect
under
this
section
and
the
quantity
of
the
residue
is
within
the
limits
of
the
tolerance;
or
(
B)
an
exemption
from
the
requirement
of
a
tolerance
is
in
effect
under
this
section
for
the
pesticide
chemical
residue.
For
the
purposes
of
this
section,
the
term
"
food",
when
used
as
a
noun
without
modification,
shall
mean
a
raw
agricultural
commodity
or
processed
food.
(
2)
PROCESSED
FOOD.
CNotwithstanding
paragraph
(
1)
C
(
A)
if
a
tolerance
is
in
effect
under
this
section
for
a
pesticide
chemical
residue
in
or
on
a
raw
agricultural
commodity,
a
pesticide
chemical
residue
that
is
present
in
or
on
a
processed
food
because
the
food
is
made
from
that
raw
agricultural
commodity
shall
not
be
considered
unsafe
within
the
meaning
of
section
342(
a)(
2)(
B)
of
this
title
despite
the
lack
of
a
tolerance
for
the
pesticide
chemical
residue
in
or
on
the
processed
food
if
the
pesticide
chemical
has
been
used
in
or
on
the
raw
agricultural
commodity
in
conformity
with
a
tolerance
under
this
section,
such
residue
in
or
on
the
raw
agricultural
commodity
has
been
removed
to
the
extent
possible
in
good
manufacturing
practice,
and
the
concentration
of
the
pesticide
chemical
residue
in
the
processed
food
is
not
greater
than
the
tolerance
prescribed
for
the
pesticide
chemical
residue
in
the
raw
agricultural
commodity;
or
(
B)
if
an
exemption
for
the
requirement
for
a
tolerance
is
in
effect
under
this
section
for
a
pesticide
chemical
residue
in
or
on
a
raw
agricultural
commodity,
a
pesticide
chemical
residue
that
is
present
in
or
on
a
processed
food
because
the
food
is
made
from
that
raw
agricultural
commodity
shall
not
be
considered
unsafe
within
the
meaning
of
section
342(
a)(
2)(
B)
of
this
title.
(
3)
RESIDUES
OF
DEGRADATION
PRODUCTS.
CIf
a
pesticide
chemical
residue
is
present
in
or
on
a
food
because
it
is
a
metabolite
or
other
degradation
product
of
a
precursor
substance
that
itself
is
a
pesticide
chemical
or
pesticide
chemical
residue,
such
a
residue
shall
not
be
considered
to
be
unsafe
within
the
meaning
of
section
342(
a)(
2)(
B)
of
this
title
despite
the
lack
of
a
tolerance
or
exemption
from
the
need
for
a
tolerance
for
such
residue
in
or
on
such
food
ifC
(
A)
the
Administrator
has
not
determined
that
the
degradation
product
is
likely
to
pose
any
potential
health
risk
from
dietary
exposure
that
is
of
a
different
type
than,
or
of
a
greater
significance
than,
any
risk
posed
by
dietary
exposure
to
the
precursor
substance;
(
B)
eitherC
(
i)
a
tolerance
is
in
effect
under
this
section
for
residues
of
the
precursor
substance
in
or
on
the
food,
and
the
combined
level
of
residues
of
the
degradation
October
29,
2004
Page
40
of
91
product
and
the
precursor
substance
in
or
on
the
food
is
at
or
below
the
stoichiometrically
equivalent
level
that
would
be
permitted
by
the
tolerance
if
the
residue
consisted
only
of
the
precursor
substance
rather
than
the
degradation
product;
or
(
ii)
an
exemption
from
the
need
for
a
tolerance
is
in
effect
under
this
section
for
residues
of
the
precursor
substance
in
or
on
the
food;
and
(
C)
the
tolerance
or
exemption
for
residues
of
the
precursor
substance
does
not
state
that
it
applies
only
to
particular
named
substances
and
does
not
state
that
it
does
not
apply
to
residues
of
the
degradation
product.
(
4)
EFFECT
OF
TOLERANCE
OR
EXEMPTION.
CWhile
a
tolerance
or
exemption
from
the
requirement
for
a
tolerance
is
in
effect
under
this
section
for
a
pesticide
chemical
residue
with
respect
to
any
food,
the
food
shall
not
by
reason
of
bearing
or
containing
any
amount
of
such
a
residue
be
considered
to
be
adulterated
within
the
meaning
of
section
342(
a)(
1)
of
this
title.
(
b)
AUTHORITY
AND
STANDARD
FOR
TOLERANCE.
C
(
1)
AUTHORITY.
CThe
Administrator
may
issue
regulations
establishing,
modifying,
or
revoking
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
foodC
(
A)
in
response
to
a
petition
filed
under
subsection
(
d)
of
this
section;
or
(
B)
on
the
Administrator's
own
initiative
under
subsection
(
e)
of
this
section.
As
used
in
this
section,
the
term
"
modify"
shall
not
mean
expanding
the
tolerance
to
cover
additional
foods.
(
2)
STANDARD.
C
(
A)
GENERAL
RULE.
C
(
i)
STANDARD.
CThe
Administrator
may
establish
or
leave
in
effect
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food
only
if
the
Administrator
determines
that
the
tolerance
is
safe.
The
Administrator
shall
modify
or
revoke
a
tolerance
if
the
Administrator
determines
it
is
not
safe.
(
ii)
DETERMINATION
OF
SAFETY.
CAs
used
in
this
section,
the
term
"
safe",
with
respect
to
a
tolerance
for
a
pesticide
chemical
residue,
means
that
the
Administrator
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
(
iii)
RULE
OF
CONSTRUCTION.
CWith
respect
to
a
tolerance,
a
pesticide
chemical
residue
meeting
the
standard
under
clause
(
i)
is
not
an
eligible
pesticide
chemical
residue
for
purposes
of
subparagraph
(
B).
(
B)
TOLERANCES
FOR
ELIGIBLE
PESTICIDE
CHEMICAL
RESIDUES.
C
(
i)
DEFINITION.
CAs
used
in
this
subparagraph,
the
term
"
eligible
pesticide
chemical
residue"
means
a
pesticide
chemical
residue
as
to
whichC
(
I)
the
Administrator
is
not
able
to
identify
a
level
of
exposure
to
the
residue
at
which
the
residue
will
not
cause
or
contribute
to
a
known
or
anticipated
harm
to
human
health
(
referred
to
in
this
section
as
a
"
nonthreshold
effect");
(
II)
the
lifetime
risk
of
experiencing
the
nonthreshold
effect
is
October
29,
2004
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41
of
91
appropriately
assessed
by
quantitative
risk
assessment;
and
(
III)
with
regard
to
any
known
or
anticipated
harm
to
human
health
for
which
the
Administrator
is
able
to
identify
a
level
at
which
the
residue
will
not
cause
such
harm
(
referred
to
in
this
section
as
a
"
nonthreshold
effect"),
the
Administrator
determines
that
the
level
of
aggregate
exposure
is
safe.
(
ii)
DETERMINATION
OF
TOLERANCE.
CNotwithstanding
subparagraph
(
A)(
i),
a
tolerance
for
an
eligible
pesticide
chemical
residue
may
be
left
in
effect
or
modified
under
this
subparagraph
ifC
(
I)
at
least
one
of
the
conditions
described
in
clause
(
iii)
is
met;
and
(
II)
both
of
the
conditions
described
in
clause
(
iv)
are
met.
(
iii)
CONDITIONS
REGARDING
USE.
CFor
purposes
of
clause
(
ii),
the
conditions
described
in
this
clause
with
respect
to
a
tolerance
for
an
eligible
pesticide
chemical
residue
are
the
following:
(
I)
Use
of
the
pesticide
chemical
that
produces
the
residue
protects
consumers
from
adverse
effects
on
health
that
would
pose
a
greater
risk
than
the
dietary
risk
from
the
residue.
(
II)
Use
of
the
pesticide
chemical
that
produces
the
residue
is
necessary
to
avoid
a
significant
disruption
in
domestic
production
of
an
adequate,
wholesome,
and
economical
food
supply.
(
iv)
CONDITIONS
REGARDING
RISK.
CFor
purposes
of
clause
(
ii),
the
conditions
described
in
this
clause
with
respect
to
a
tolerance
for
an
eligible
pesticide
chemical
residue
are
the
following:
(
I)
The
yearly
risk
associated
with
the
nonthreshold
effect
from
aggregate
exposure
to
the
residue
does
not
exceed
10
times
the
yearly
risk
that
would
be
allowed
under
subparagraph
(
A)
for
such
effect.
(
II)
The
tolerance
is
limited
so
as
to
ensure
that
the
risk
over
a
lifetime
associated
with
the
nonthreshold
effect
from
aggregate
exposure
to
the
residue
is
not
greater
than
twice
the
lifetime
risk
that
would
be
allowed
under
subparagraph
(
A)
for
such
effect.
(
v)
REVIEW.
CFive
years
after
the
date
on
which
the
Administrator
makes
a
determination
to
leave
in
effect
or
modify
a
tolerance
under
this
subparagraph,
and
thereafter
as
the
Administrator
deems
appropriate,
the
Administrator
shall
determine,
after
notice
and
opportunity
for
comment,
whether
it
has
been
demonstrated
to
the
Administrator
that
a
condition
described
in
clause
(
iii)(
I)
or
clause
(
iii)(
II)
continues
to
exist
with
respect
to
the
tolerance
and
that
the
yearly
and
lifetime
risks
from
aggregate
exposure
to
such
residue
continue
to
comply
with
the
limits
specified
in
clause
(
iv).
If
the
Administrator
determines
by
such
date
that
such
demonstration
has
not
been
made,
the
Administrator
shall,
not
later
than
180
days
after
the
date
of
such
determination,
issue
a
regulation
under
subsection
(
e)(
1)
of
this
section
to
modify
or
revoke
the
tolerance.
(
vi)
INFANTS
AND
CHILDREN.
CAny
tolerance
under
this
subparagraph
shall
meet
the
requirements
of
subparagraph
(
C).
(
C)
EXPOSURE
OF
INFANTS
AND
CHILDREN.
CIn
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
or
exemption
for
a
pesticide
chemical
residue,
October
29,
2004
Page
42
of
91
the
AdministratorC
(
i)
shall
assess
the
risk
of
the
pesticide
chemical
residue
based
onC
(
I)
available
information
about
consumption
patterns
among
infants
and
children
that
are
likely
to
result
in
disproportionately
high
consumption
of
foods
containing
or
bearing
such
residue
among
infants
and
children
in
comparison
to
the
general
population;
(
II)
available
information
concerning
the
special
susceptibility
of
infants
and
children
to
the
pesticide
chemical
residues,
including
neurological
differences
between
infants
and
children
and
adults,
and
effects
of
in
utero
exposure
to
pesticide
chemicals;
and
(
III)
available
information
concerning
the
cumulative
effects
on
infants
and
children
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity;
and
(
ii)
shallC
(
I)
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue;
and
(
II)
publish
a
specific
determination
regarding
the
safety
of
the
pesticide
chemical
residue
for
infants
and
children.
The
Secretary
of
Health
and
Human
Services
and
the
Secretary
of
Agriculture,
in
consultation
with
the
Administrator,
shall
conduct
surveys
to
document
dietary
exposure
to
pesticides
among
infants
and
children.
In
the
case
of
threshold
effects,
for
purposes
of
clause
(
ii)(
I)
an
additional
tenfold
margin
of
safety
for
the
pesticide
chemical
residue
and
other
sources
of
exposure
shall
be
applied
for
infants
and
children
to
take
into
account
potential
pre­
and
post­
natal
toxicity
and
completeness
of
the
data
with
respect
to
exposure
and
toxicity
to
infants
and
children.
Notwithstanding
such
requirement
for
an
additional
margin
of
safety,
the
Administrator
may
use
a
different
margin
of
safety
for
the
pesticide
chemical
residue
only
if,
on
the
basis
of
reliable
data,
such
margin
will
be
safe
for
infants
and
children.
(
D)
FACTORS.
CIn
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
or
exemption
for
a
pesticide
chemical
residue,
the
Administrator
shall
consider,
among
other
relevant
factorsC
(
i)
the
validity,
completeness,
and
reliability
of
the
available
data
from
studies
of
the
pesticide
chemical
and
pesticide
chemical
residue;
(
ii)
the
nature
of
any
toxic
effect
shown
to
be
caused
by
the
pesticide
chemical
or
pesticide
chemical
residue
in
such
studies;
(
iii)
available
information
concerning
the
relationship
of
the
results
of
such
studies
to
human
risk;
(
iv)
available
information
concerning
the
dietary
consumption
patterns
of
consumers
(
and
major
identifiable
subgroups
of
consumers);
(
v)
available
information
concerning
the
cumulative
effects
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity;
(
vi)
available
information
concerning
the
aggregate
exposure
levels
of
consumers
(
and
major
identifiable
subgroups
of
consumers)
to
the
pesticide
October
29,
2004
Page
43
of
91
chemical
residue
and
to
other
related
substances,
including
dietary
exposure
under
the
tolerance
and
all
other
tolerances
in
effect
for
the
pesticide
chemical
residue,
and
exposure
from
other
non­
occupational
sources;
(
vii)
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers;
(
viii)
such
information
as
the
Administrator
may
require
on
whether
the
pesticide
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects;
and
(
ix)
safety
factors
which
in
the
opinion
of
experts
qualified
by
scientific
training
and
experience
to
evaluate
the
safety
of
food
additives
are
generally
recognized
as
appropriate
for
the
use
of
animal
experimentation
data.
(
E)
DATA
AND
INFORMATION
REGARDING
ANTICIPATED
AND
ACTUAL
RESIDUE
LEVELS.
C
(
i)
AUTHORITY.
C
In
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
for
a
pesticide
chemical
residue,
the
Administrator
may
consider
available
data
and
information
on
the
anticipated
residue
levels
of
the
pesticide
chemical
in
or
on
food
and
the
actual
residue
levels
of
the
pesticide
chemical
that
have
been
measured
in
food,
including
residue
data
collected
by
the
Food
and
Drug
Administration.
(
ii)
REQUIREMENT.
CIf
the
Administrator
relies
on
anticipated
or
actual
residue
levels
in
establishing,
modifying,
or
leaving
in
effect
a
tolerance,
the
Administrator
shall
pursuant
to
subsection
(
f)(
1)
of
this
section
require
that
data
be
provided
five
years
after
the
date
on
which
the
tolerance
is
established,
modified,
or
left
in
effect,
and
thereafter
as
the
Administrator
deems
appropriate,
demonstrating
that
such
residue
levels
are
not
above
the
levels
so
relied
on.
If
such
data
are
not
so
provided,
or
if
the
data
do
not
demonstrate
that
the
residue
levels
are
not
above
the
levels
so
relied
on,
the
Administrator
shall,
not
later
than
180
days
after
the
date
on
which
the
data
were
required
to
be
provided,
issue
a
regulation
under
subsection
(
e)(
1)
of
this
section,
or
an
order
under
subsection
(
f)(
2)
of
this
section,
as
appropriate,
to
modify
or
revoke
the
tolerance.
(
F)
PERCENT
OF
FOOD
ACTUALLY
TREATED.
CIn
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
for
a
pesticide
chemical
residue,
the
Administrator
may,
when
assessing
chronic
dietary
risk,
consider
available
data
and
information
on
the
percent
of
food
actually
treated
with
the
pesticide
chemical
(
including
aggregate
pesticide
use
data
collected
by
the
Department
of
Agriculture)
only
if
the
AdministratorC
(
i)
finds
that
the
data
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
chemical
residue;
(
ii)
finds
that
the
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group;
(
iii)
finds
that,
if
data
are
available
on
pesticide
use
and
consumption
of
food
in
a
particular
area,
the
population
in
such
area
is
not
dietarily
exposed
to
residues
above
those
estimated
by
the
Administrator;
and
October
29,
2004
Page
44
of
91
(
iv)
provides
for
the
periodic
reevaluation
of
the
estimate
of
anticipated
dietary
exposure.
(
3)
DETECTION
METHODS.
C
(
A)
GENERAL
RULE.
CA
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food
shall
not
be
established
or
modified
by
the
Administrator
unless
the
Administrator
determines,
after
consultation
with
the
Secretary,
that
there
is
a
practical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
chemical
residue
in
or
on
the
food.

(
B)
DETECTION
LIMIT.
CA
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food
shall
not
be
established
at
or
modified
to
a
level
lower
than
the
limit
of
detection
of
the
method
for
detecting
and
measuring
the
pesticide
chemical
residue
specified
by
the
Administrator
under
subparagraph
(
A).
(
4)
INTERNATIONAL
STANDARDS.
CIn
establishing
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food,
the
Administrator
shall
determine
whether
a
maximum
residue
level
for
the
pesticide
chemical
has
been
established
by
the
Codex
Alimentarius
Commission.
If
a
Codex
maximum
residue
level
has
been
established
for
the
pesticide
chemical
and
the
Administrator
does
not
propose
to
adopt
the
Codex
level,
the
Administrator
shall
publish
for
public
comment
a
notice
explaining
the
reasons
for
departing
from
the
Codex
level.
(
c)
AUTHORITY
AND
STANDARD
FOR
EXEMPTIONS.
C
(
1)
AUTHORITY.
CThe
Administrator
may
issue
a
regulation
establishing,
modifying,
or
revoking
an
exemption
from
the
requirement
for
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
foodC
(
A)
in
response
to
a
petition
filed
under
subsection
(
d)
of
this
section;
or
(
B)
on
the
Administrator's
initiative
under
subsection
(
e)
of
this
section.
(
2)
STANDARD.
C
(
A)
GENERAL
RULE.
C
(
i)
STANDARD.
CThe
Administrator
may
establish
or
leave
in
effect
an
exemption
from
the
requirement
for
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food
only
if
the
Administrator
determines
that
the
exemption
is
safe.
The
Administrator
shall
modify
or
revoke
an
exemption
if
the
Administrator
determines
it
is
not
safe.
(
ii)
DETERMINATION
OF
SAFETY.
CThe
term"
safe'',
with
respect
to
an
exemption
for
a
pesticide
chemical
residue,
means
that
the
Administrator
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
(
B)
FACTORS.
CIn
making
a
determination
under
this
paragraph,
the
Administrator
shall
take
into
account,
among
other
relevant
considerations,
the
considerations
set
forth
in
subparagraphs
(
C)
and
(
D)
of
subsection
(
b)(
2)
of
this
section.
(
3)
LIMITATION.
CAn
exemption
from
the
requirement
for
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food
shall
not
be
established
or
modified
by
the
Administrator
unless
the
Administrator
determines,
after
consultation
with
the
SecretaryC
October
29,
2004
Page
45
of
91
(
A)
that
there
is
a
practical
method
for
detecting
and
measuring
the
levels
of
such
pesticide
chemical
residue
in
or
on
food;
or
(
B)
that
there
is
no
need
for
such
a
method,
and
states
the
reasons
for
such
determination
in
issuing
the
regulation
establishing
or
modifying
the
exemption.
(
d)
PETITION
FOR
TOLERANCE
OR
EXEMPTION.
C
(
1)
PETITIONS
AND
PETITIONERS.
CAny
person
may
file
with
the
Administrator
a
petition
proposing
the
issuance
of
a
regulationC
(
A)
establishing,
modifying,
or
revoking
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food;
or
(
B)
establishing,
modifying,
or
revoking
an
exemption
from
the
requirement
of
a
tolerance
for
such
a
residue.
(
2)
PETITION
CONTENTS.
C
(
A)
ESTABLISHMENT.
CA
petition
under
paragraph
(
1)
to
establish
a
tolerance
or
exemption
for
a
pesticide
chemical
residue
shall
be
supported
by
such
data
and
information
as
are
specified
in
regulations
issued
by
the
Administrator,
includingC
(
i)(
I)
an
informative
summary
of
the
petition
and
of
the
data,
information,
and
arguments
submitted
or
cited
in
support
of
the
petition;
and
(
II)
a
statement
that
the
petitioner
agrees
that
such
summary
or
any
information
it
contains
may
be
published
as
a
part
of
the
notice
of
filing
of
the
petition
to
be
published
under
this
subsection
and
as
part
of
a
proposed
or
final
regulation
issued
under
this
section;
(
ii)
the
name,
chemical
identity,
and
composition
of
the
pesticide
chemical
residue
and
of
the
pesticide
chemical
that
produces
the
residue;
(
iii)
data
showing
the
recommended
amount,
frequency,
method,
and
time
of
application
of
that
pesticide
chemical;
(
iv)
full
reports
of
tests
and
investigations
made
with
respect
to
the
safety
of
the
pesticide
chemical,
including
full
information
as
to
the
methods
and
controls
used
in
conducting
those
tests
and
investigations;
(
v)
full
reports
of
tests
and
investigations
made
with
respect
to
the
nature
and
amount
of
the
pesticide
chemical
residue
that
is
likely
to
remain
in
or
on
the
food,
including
a
description
of
the
analytical
methods
used;
(
vi)
a
practical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
chemical
residue
in
or
on
the
food,
or
for
exemptions,
a
statement
why
such
a
method
is
not
needed;
(
vii)
a
proposed
tolerance
for
the
pesticide
chemical
residue,
if
a
tolerance
is
proposed;
(
viii)
if
the
petition
relates
to
a
tolerance
for
a
processed
food,
reports
of
investigations
conducted
using
the
processing
method(
s)
used
to
produce
that
food;
(
ix)
such
information
as
the
Administrator
may
require
to
make
the
determination
under
subsection
(
b)(
2)(
C)
of
this
section;
(
x)
such
information
as
the
Administrator
may
require
on
whether
the
pesticide
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects;
October
29,
2004
Page
46
of
91
(
xi)
information
regarding
exposure
to
the
pesticide
chemical
residue
due
to
any
tolerance
or
exemption
already
granted
for
such
residue;
(
xii)
practical
methods
for
removing
any
amount
of
the
residue
that
would
exceed
any
proposed
tolerance;
and
(
xiii)
such
other
data
and
information
as
the
Administrator
requires
by
regulation
to
support
the
petition.
If
information
or
data
required
by
this
subparagraph
is
available
to
the
Administrator,
the
person
submitting
the
petition
may
cite
the
availability
of
the
information
or
data
in
lieu
of
submitting
it.
The
Administrator
may
require
a
petition
to
be
accompanied
by
samples
of
the
pesticide
chemical
with
respect
to
which
the
petition
is
filed.
(
B)
MODIFICATION
OR
REVOCATION.
CThe
Administrator
may
by
regulation
establish
the
requirements
for
information
and
data
to
support
a
petition
to
modify
or
revoke
a
tolerance
or
to
modify
or
revoke
an
exemption
from
the
requirement
for
a
tolerance.
(
3)
NOTICE.
CA
notice
of
the
filing
of
a
petition
that
the
Administrator
determines
has
met
the
requirements
of
paragraph
(
2)
shall
be
published
by
the
Administrator
within
30
days
after
such
determination.
The
notice
shall
announce
the
availability
of
a
description
of
the
analytical
methods
available
to
the
Administrator
for
the
detection
and
measurement
of
the
pesticide
chemical
residue
with
respect
to
which
the
petition
is
filed
or
shall
set
forth
the
petitioner's
statement
of
why
such
a
method
is
not
needed.
The
notice
shall
include
the
summary
required
by
paragraph
(
2)(
A)(
i)(
I).
(
4)
ACTIONS
BY
THE
ADMINISTRATOR.
C
(
A)
IN
GENERAL.
CThe
Administrator
shall,
after
giving
due
consideration
to
a
petition
filed
under
paragraph
(
1)
and
any
other
information
available
to
the
AdministratorC
(
i)
issue
a
final
regulation
(
which
may
vary
from
that
sought
by
the
petition)
establishing,
modifying,
or
revoking
a
tolerance
for
the
pesticide
chemical
residue
or
an
exemption
of
the
pesticide
chemical
residue
from
the
requirement
of
a
tolerance
(
which
final
regulation
shall
be
issued
without
further
notice
and
without
further
period
for
public
comment);
(
ii)
issue
a
proposed
regulation
under
subsection
(
e)
of
this
section,
and
thereafter
issue
a
final
regulation
under
such
subsection;
or
(
iii)
issue
an
order
denying
the
petition.
(
B)
PRIORITIES.
CThe
Administrator
shall
give
priority
to
petitions
for
the
establishment
or
modification
of
a
tolerance
or
exemption
for
a
pesticide
chemical
residue
that
appears
to
pose
a
significantly
lower
risk
to
human
health
from
dietary
exposure
than
pesticide
chemical
residues
that
have
tolerances
in
effect
for
the
same
or
similar
uses.
(
C)
EXPEDITED
REVIEW
OF
CERTAIN
PETITIONS.
C
(
i)
DATE
CERTAIN
FOR
REVIEW.
CIf
a
person
files
a
complete
petition
with
the
Administrator
proposing
the
issuance
of
a
regulation
establishing
a
tolerance
or
exemption
for
a
pesticide
chemical
residue
that
presents
a
lower
risk
to
human
health
than
a
pesticide
chemical
residue
for
which
a
tolerance
has
been
left
in
effect
or
modified
under
subsection
(
b)(
2)(
B)
of
this
section,
the
October
29,
2004
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47
of
91
Administrator
shall
complete
action
on
such
petition
under
this
paragraph
within
1
year.
(
ii)
REQUIRED
DETERMINATIONS.
CIf
the
Administrator
issues
a
final
regulation
establishing
a
tolerance
or
exemption
for
a
safer
pesticide
chemical
residue
under
clause
(
i),
the
Administrator
shall,
not
later
than
180
days
after
the
date
on
which
the
regulation
is
issued,
determine
whether
a
condition
described
in
subclause
(
I)
or
(
II)
of
subsection
(
b)(
2)(
B)(
iii)
of
this
section
continues
to
exist
with
respect
to
a
tolerance
that
has
been
left
in
effect
or
modified
under
subsection
(
b)(
2)(
B)
of
this
section.
If
such
condition
does
not
continue
to
exist,
the
Administrator
shall,
not
later
than
180
days
after
the
date
on
which
the
determination
under
the
preceding
sentence
is
made,
issue
a
regulation
under
subsection
(
e)(
1)
of
this
section
to
modify
or
revoke
the
tolerance.
(
e)
ACTION
ON
ADMINISTRATOR'S
OWN
INITIATIVE.
C
(
1)
GENERAL
RULE.
CThe
Administrator
may
issue
a
regulationC
(
A)
establishing,
modifying,
suspending
under
subsection
(
l)(
3)
of
this
section,
or
revoking
a
tolerance
for
a
pesticide
chemical
or
a
pesticide
chemical
residue;
(
B)
establishing,
modifying,
suspending
under
subsection
(
l)(
3)
of
this
section,
or
revoking
an
exemption
of
a
pesticide
chemical
residue
from
the
requirement
of
a
tolerance;
or
(
C)
establishing
general
procedures
and
requirements
to
implement
this
section.
(
2)
NOTICE.
CBefore
issuing
a
final
regulation
under
paragraph
(
1),
the
Administrator
shall
issue
a
notice
of
proposed
rulemaking
and
provide
a
period
of
not
less
than
60
days
for
public
comment
on
the
proposed
regulation,
except
that
a
shorter
period
for
comment
may
be
provided
if
the
Administrator
for
good
cause
finds
that
it
would
be
in
the
public
interest
to
do
so
and
states
the
reasons
for
the
finding
in
the
notice
of
proposed
rulemaking.
(
f)
SPECIAL
DATA
REQUIREMENTS.
C
(
1)
REQUIRING
SUBMISSION
OF
ADDITIONAL
DATA.
CIf
the
Administrator
determines
that
additional
data
or
information
are
reasonably
required
to
support
the
continuation
of
a
tolerance
or
exemption
that
is
in
effect
under
this
section
for
a
pesticide
chemical
residue
on
a
food,
the
Administrator
shallC
(
A)
issue
a
notice
requiring
the
person
holding
the
pesticide
registrations
associated
with
such
tolerance
or
exemption
to
submit
the
data
or
information
under
section
3(
c)(
2)(
B)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136a(
c)(
2)(
B));
(
B)
issue
a
rule
requiring
that
testing
be
conducted
on
a
substance
or
mixture
under
section
4
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2603);
or
(
C)
publish
in
the
Federal
Register,
after
first
providing
notice
and
an
opportunity
for
comment
of
not
less
than
60
days'
duration,
an
orderC
(
i)
requiring
the
submission
to
the
Administrator
by
one
or
more
interested
persons
of
a
notice
identifying
the
person
or
persons
who
will
submit
the
required
data
and
information;
(
ii)
describing
the
type
of
data
and
information
required
to
be
submitted
to
the
Administrator
and
stating
why
the
data
and
information
could
not
be
obtained
under
the
authority
of
section
3(
c)(
2)(
B)
of
the
Federal
Insecticide,
Fungicide,
and
October
29,
2004
Page
48
of
91
Rodenticide
Act
(
7
U.
S.
C.
136a(
c)(
2)(
B))
or
section
4
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2603);
(
iii)
describing
the
reports
of
the
Administrator
required
to
be
prepared
during
and
after
the
collection
of
the
data
and
information;
(
iv)
requiring
the
submission
to
the
Administrator
of
the
data,
information,
and
reports
referred
to
in
clauses
(
ii)
and
(
iii);
and
(
v)
establishing
dates
by
which
the
submissions
described
in
clauses
(
i)
and
(
iv)
must
be
made.
The
Administrator
may
under
subparagraph
(
C)
revise
any
such
order
to
correct
an
error.
The
Administrator
may
under
this
paragraph
require
data
or
information
pertaining
to
whether
the
pesticide
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects.
(
2)
NONCOMPLIANCE.
CIf
a
submission
required
by
a
notice
issued
in
accordance
with
paragraph
(
1)(
A),
a
rule
issued
under
paragraph
(
1)(
B),
or
an
order
issued
under
paragraph
(
1)(
C)
is
not
made
by
the
time
specified
in
such
notice,
rule,
or
order,
the
Administrator
may
by
order
published
in
the
Federal
Register
modify
or
revoke
the
tolerance
or
exemption
in
question.
In
any
review
of
such
an
order
under
subsection
(
g)(
2)
of
this
section,
the
only
material
issue
shall
be
whether
a
submission
required
under
paragraph
(
1)
was
not
made
by
the
time
specified.
(
g)
EFFECTIVE
DATE,
OBJECTIONS,
HEARINGS,
AND
ADMINISTRATIVE
REVIEW.
C
(
1)
EFFECTIVE
DATE.
CA
regulation
or
order
issued
under
subsection
(
d)(
4),
(
e)(
1),
or
(
f)(
2)
of
this
section
shall
take
effect
upon
publication
unless
the
regulation
or
order
specifies
otherwise.
The
Administrator
may
stay
the
effectiveness
of
the
regulation
or
order
if,
after
issuance
of
such
regulation
or
order,
objections
are
filed
with
respect
to
such
regulation
or
order
pursuant
to
paragraph
(
2).
(
2)
FURTHER
PROCEEDINGS.
C
(
A)
OBJECTIONS.
CWithin
60
days
after
a
regulation
or
order
is
issued
under
subsection
(
d)(
4),
(
e)(
1)(
A),
(
e)(
1)(
B),
(
f)(
2),
(
n)(
3),
or
(
n)(
5)(
C)
of
this
section,
any
person
may
file
objections
thereto
with
the
Administrator,
specifying
with
particularity
the
provisions
of
the
regulation
or
order
deemed
objectionable
and
stating
reasonable
grounds
therefor.
If
the
regulation
or
order
was
issued
in
response
to
a
petition
under
subsection
(
d)(
1)
of
this
section,
a
copy
of
each
objection
filed
by
a
person
other
than
the
petitioner
shall
be
served
by
the
Administrator
on
the
petitioner.
(
B)
HEARING.
CAn
objection
may
include
a
request
for
a
public
evidentiary
hearing
upon
the
objection.
The
Administrator
shall,
upon
the
initiative
of
the
Administrator
or
upon
the
request
of
an
interested
person
and
after
due
notice,
hold
a
public
evidentiary
hearing
if
and
to
the
extent
the
Administrator
determines
that
such
a
public
hearing
is
necessary
to
receive
factual
evidence
relevant
to
material
issues
of
fact
raised
by
the
objections.
The
presiding
officer
in
such
a
hearing
may
authorize
a
party
to
obtain
discovery
from
other
persons
and
may
upon
a
showing
of
good
cause
made
by
a
party
issue
a
subpoena
to
compel
testimony
or
production
of
documents
from
any
person.
The
presiding
officer
shall
be
governed
by
the
Federal
Rules
of
Civil
Procedure
in
making
any
order
for
the
protection
of
the
witness
or
the
content
of
documents
October
29,
2004
Page
49
of
91
produced
and
shall
order
the
payment
of
reasonable
fees
and
expenses
as
a
condition
to
requiring
testimony
of
the
witness.
On
contest,
such
a
subpoena
may
be
enforced
by
a
Federal
district
court.
(
C)
FINAL
DECISION.
CAs
soon
as
practicable
after
receiving
the
arguments
of
the
parties,
the
Administrator
shall
issue
an
order
stating
the
action
taken
upon
each
such
objection
and
setting
forth
any
revision
to
the
regulation
or
prior
order
that
the
Administrator
has
found
to
be
warranted.
If
a
hearing
was
held
under
subparagraph
(
B),
such
order
and
any
revision
to
the
regulation
or
prior
order
shall,
with
respect
to
questions
of
fact
at
issue
in
the
hearing,
be
based
only
on
substantial
evidence
of
record
at
such
hearing,
and
shall
set
forth
in
detail
the
findings
of
facts
and
the
conclusions
of
law
or
policy
upon
which
the
order
or
regulation
is
based.
(
h)
JUDICIAL
REVIEW.
C
(
1)
PETITION.
CIn
a
case
of
actual
controversy
as
to
the
validity
of
any
regulation
issued
under
subsection
(
e)(
1)(
C)
of
this
section,
or
any
order
issued
under
subsection
(
f)(
1)(
C)
or
(
g)(
2)(
C)
of
this
section,
or
any
regulation
that
is
the
subject
of
such
an
order,
any
person
who
will
be
adversely
affected
by
such
order
or
regulation
may
obtain
judicial
review
by
filing
in
the
United
States
Court
of
Appeals
for
the
circuit
wherein
that
person
resides
or
has
its
principal
place
of
business,
or
in
the
United
States
Court
of
Appeals
for
the
District
of
Columbia
Circuit,
within
60
days
after
publication
of
such
order
or
regulation,
a
petition
praying
that
the
order
or
regulation
be
set
aside
in
whole
or
in
part.
(
2)
RECORD
AND
JURISDICTION.
CA
copy
of
the
petition
under
paragraph
(
1)
shall
be
forthwith
transmitted
by
the
clerk
of
the
court
to
the
Administrator,
or
any
officer
designated
by
the
Administrator
for
that
purpose,
and
thereupon
the
Administrator
shall
file
in
the
court
the
record
of
the
proceedings
on
which
the
Administrator
based
the
order
or
regulation,
as
provided
in
section
2112
of
title
28.
Upon
the
filing
of
such
a
petition,
the
court
shall
have
exclusive
jurisdiction
to
affirm
or
set
aside
the
order
or
regulation
complained
of
in
whole
or
in
part.
As
to
orders
issued
following
a
public
evidentiary
hearing,
the
findings
of
the
Administrator
with
respect
to
questions
of
fact
shall
be
sustained
only
if
supported
by
substantial
evidence
when
considered
on
the
record
as
a
whole.
(
3)
ADDITIONAL
EVIDENCE.
CIf
a
party
applies
to
the
court
for
leave
to
adduce
additional
evidence
and
shows
to
the
satisfaction
of
the
court
that
the
additional
evidence
is
material
and
that
there
were
reasonable
grounds
for
the
failure
to
adduce
the
evidence
in
the
proceeding
before
the
Administrator,
the
court
may
order
that
the
additional
evidence
(
and
evidence
in
rebuttal
thereof)
shall
be
taken
before
the
Administrator
in
the
manner
and
upon
the
terms
and
conditions
the
court
deems
proper.
The
Administrator
may
modify
prior
findings
as
to
the
facts
by
reason
of
the
additional
evidence
so
taken
and
may
modify
the
order
or
regulation
accordingly.
The
Administrator
shall
file
with
the
court
any
such
modified
finding,
order,
or
regulation.
(
4)
FINAL
JUDGMENT;
SUPREME
COURT
REVIEW.
CThe
judgment
of
the
court
affirming
or
setting
aside,
in
whole
or
in
part,
any
regulation
or
any
order
and
any
regulation
which
is
the
subject
of
such
an
order
shall
be
final,
subject
to
review
by
the
Supreme
Court
of
the
United
States
as
provided
in
section
1254
of
title
28.
The
commencement
of
proceedings
under
this
subsection
shall
not,
unless
specifically
ordered
by
the
court
to
the
contrary,
operate
as
a
stay
of
a
regulation
or
order.
October
29,
2004
Page
50
of
91
(
5)
APPLICATION.
CAny
issue
as
to
which
review
is
or
was
obtainable
under
this
subsection
shall
not
be
the
subject
of
judicial
review
under
any
other
provision
of
law.
(
i)
CONFIDENTIALITY
AND
USE
OF
DATA.
C
(
1)
GENERAL
RULE.
CData
and
information
that
are
or
have
been
submitted
to
the
Administrator
under
this
section
or
section
348
of
this
title
in
support
of
a
tolerance
or
an
exemption
from
a
tolerance
shall
be
entitled
to
confidential
treatment
for
reasons
of
business
confidentiality
and
to
exclusive
use
and
data
compensation
to
the
same
extent
provided
by
sections
3
and
10
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136a,
136h).
(
2)
EXCEPTIONS.
C
(
A)
IN
GENERAL.
CData
and
information
that
are
entitled
to
confidential
treatment
under
paragraph
(
1)
may
be
disclosed,
under
such
security
requirements
as
the
Administrator
may
provide
by
regulation,
toC
(
i)
employees
of
the
United
States
authorized
by
the
Administrator
to
examine
such
data
and
information
in
the
carrying
out
of
their
official
duties
under
this
chapter
or
other
Federal
statutes
intended
to
protect
the
public
health;
or
(
ii)
contractors
with
the
United
States
authorized
by
the
Administrator
to
examine
such
data
and
information
in
the
carrying
out
of
contracts
under
this
chapter
or
such
statutes.
(
B)
CONGRESS.
CThis
subsection
does
not
authorize
the
withholding
of
data
or
information
from
either
House
of
Congress
or
from,
to
the
extent
of
matter
within
its
jurisdiction,
any
committee
or
subcommittee
of
such
committee
or
any
joint
committee
of
Congress
or
any
subcommittee
of
such
joint
committee.
(
3)
SUMMARIES.
CNotwithstanding
any
provision
of
this
subsection
or
other
law,
the
Administrator
may
publish
the
informative
summary
required
by
subsection
(
d)(
2)(
A)(
i)
of
this
section
and
may,
in
issuing
a
proposed
or
final
regulation
or
order
under
this
section,
publish
an
informative
summary
of
the
data
relating
to
the
regulation
or
order.
(
j)
STATUS
OF
PREVIOUSLY
ISSUED
REGULATIONS.
C
(
1)
REGULATIONS
UNDER
SECTION
346.
CRegulations
affecting
pesticide
chemical
residues
in
or
on
raw
agricultural
commodities
promulgated,
in
accordance
with
section
371(
e)
of
this
title,
under
the
authority
of
section
346(
a)
of
this
title
upon
the
basis
of
public
hearings
instituted
before
January
1,
1953,
shall
be
deemed
to
be
regulations
issued
under
this
section
and
shall
be
subject
to
modification
or
revocation
under
subsections
(
d)
and
(
e)
of
this
section,
and
shall
be
subject
to
review
under
subsection
(
q)
of
this
section.
(
2)
REGULATIONS
UNDER
SECTION
348.
CRegulations
that
established
tolerances
for
substances
that
are
pesticide
chemical
residues
in
or
on
processed
food,
or
that
otherwise
stated
the
conditions
under
which
such
pesticide
chemicals
could
be
safely
used,
and
that
were
issued
under
section
348
of
this
title
on
or
before
August
3,
1996,
shall
be
deemed
to
be
regulations
issued
under
this
section
and
shall
be
subject
to
modification
or
revocation
under
subsection
(
d)
or
(
e)
of
this
section,
and
shall
be
subject
to
review
under
subsection
(
q)
of
this
section.
(
3)
REGULATIONS
UNDER
SECTION
346a.
CRegulations
that
established
tolerances
or
exemptions
under
this
section
that
were
issued
on
or
before
August
3,
1996,
shall
remain
in
effect
unless
modified
or
revoked
under
subsection
(
d)
or
(
e)
of
this
section,
and
shall
be
October
29,
2004
Page
51
of
91
subject
to
review
under
subsection
(
q)
of
this
section.
(
4)
CERTAIN
SUBSTANCES.
CWith
respect
to
a
substance
that
is
not
included
in
the
definition
of
the
term
"
pesticide
chemical''
under
section
321(
q)(
1)
of
this
title
but
was
so
included
on
the
day
before
October
30,
1998,
the
following
applies
as
of
October
30,
1998:
(
A)
Notwithstanding
paragraph
(
2),
any
regulation
applying
to
the
use
of
the
substance
that
was
in
effect
on
the
day
before
October
30,
1998,
and
was
on
such
day
deemed
in
such
paragraph
to
have
been
issued
under
this
section,
shall
be
considered
to
have
been
issued
under
section
348
of
this
title.
(
B)
Notwithstanding
paragraph
(
3),
any
regulation
applying
to
the
use
of
the
substance
that
was
in
effect
on
such
day
and
was
issued
under
this
section
(
including
any
such
regulation
issued
before
August
3,
1996)
is
deemed
to
have
been
issued
under
section
348
of
this
title.
(
k)
TRANSITIONAL
PROVISION.
CIf,
on
the
day
before
August
3,
1996,
a
substance
that
is
a
pesticide
chemical
was,
with
respect
to
a
particular
pesticidal
use
of
the
substance
and
any
resulting
pesticide
chemical
residue
in
or
on
a
particular
foodC
(
1)
regarded
by
the
Administrator
or
the
Secretary
as
generally
recognized
as
safe
for
use
within
the
meaning
of
the
provisions
of
subsection
(
a)
of
this
section
or
section
321(
s)
of
this
title
as
then
in
effect;
or
(
2)
regarded
by
the
Secretary
as
a
substance
described
by
section
321(
s)(
4)
of
this
title;
such
a
pesticide
chemical
residue
shall
be
regarded
as
exempt
from
the
requirement
for
a
tolerance,
as
of
August
3,
1996.
The
Administrator
shall
by
regulation
indicate
which
substances
are
described
by
this
subsection.
Any
exemption
under
this
subsection
may
be
modified
or
revoked
as
if
it
had
been
issued
under
subsection
(
c)
of
this
section.
(
l)
HARMONIZATION
WITH
ACTION
UNDER
OTHER
LAWS.
C
(
1)
COORDINATION
WITH
FIFRA.
CTo
the
extent
practicable
and
consistent
with
the
review
deadlines
in
subsection
(
q)
of
this
section,
in
issuing
a
final
rule
under
this
subsection
that
suspends
or
revokes
a
tolerance
or
exemption
for
a
pesticide
chemical
residue
in
or
on
food,
the
Administrator
shall
coordinate
such
action
with
any
related
necessary
action
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136
et
seq.).
(
2)
REVOCATION
OF
TOLERANCE
OR
EXEMPTION
FOLLOWING
CANCELLATION
OF
ASSOCIATED
REGISTRATIONS.
CIf
the
Administrator,
acting
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act,
cancels
the
registration
of
each
pesticide
that
contains
a
particular
pesticide
chemical
and
that
is
labeled
for
use
on
a
particular
food,
or
requires
that
the
registration
of
each
such
pesticide
be
modified
to
prohibit
its
use
in
connection
with
the
production,
storage,
or
transportation
of
such
food,
due
in
whole
or
in
part
to
dietary
risks
to
humans
posed
by
residues
of
that
pesticide
chemical
on
that
food,
the
Administrator
shall
revoke
any
tolerance
or
exemption
that
allows
the
presence
of
the
pesticide
chemical,
or
any
pesticide
chemical
residue
that
results
from
its
use,
in
or
on
that
food.
Subsection
(
e)
of
this
section
shall
apply
to
actions
taken
under
this
paragraph.
A
revocation
under
this
paragraph
shall
become
effective
not
later
than
180
days
afterC
(
A)
the
date
by
which
each
such
cancellation
of
a
registration
has
become
effective;
or
(
B)
the
date
on
which
the
use
of
the
canceled
pesticide
becomes
unlawful
under
the
terms
of
the
cancellation,
whichever
is
later.
October
29,
2004
Page
52
of
91
(
3)
SUSPENSION
OF
TOLERANCE
OR
EXEMPTION
FOLLOWING
SUSPENSION
OF
ASSOCIATED
REGISTRATIONS.
C
(
A)
SUSPENSION.
CIf
the
Administrator,
acting
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act,
suspends
the
use
of
each
registered
pesticide
that
contains
a
particular
pesticide
chemical
and
that
is
labeled
for
use
on
a
particular
food,
due
in
whole
or
in
part
to
dietary
risks
to
humans
posed
by
residues
of
that
pesticide
chemical
on
that
food,
the
Administrator
shall
suspend
any
tolerance
or
exemption
that
allows
the
presence
of
the
pesticide
chemical,
or
any
pesticide
chemical
residue
that
results
from
its
use,
in
or
on
that
food.
Subsection
(
e)
of
this
section
shall
apply
to
actions
taken
under
this
paragraph.
A
suspension
under
this
paragraph
shall
become
effective
not
later
than
60
days
after
the
date
by
which
each
such
suspension
of
use
has
become
effective.
(
B)
EFFECT
OF
SUSPENSION.
CThe
suspension
of
a
tolerance
or
exemption
under
subparagraph
(
A)
shall
be
effective
as
long
as
the
use
of
each
associated
registration
of
a
pesticide
is
suspended
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act.
While
a
suspension
of
a
tolerance
or
exemption
is
effective
the
tolerance
or
exemption
shall
not
be
considered
to
be
in
effect.
If
the
suspension
of
use
of
the
pesticide
under
that
Act
is
terminated,
leaving
the
registration
of
the
pesticide
for
such
use
in
effect
under
that
Act,
the
Administrator
shall
rescind
any
associated
suspension
of
tolerance
or
exemption.
(
4)
TOLERANCES
FOR
UNAVOIDABLE
RESIDUES.
CIn
connection
with
action
taken
under
paragraph
(
2)
or
(
3),
or
with
respect
to
pesticides
whose
registrations
were
suspended
or
canceled
prior
to
August
3,
1996,
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act,
if
the
Administrator
determines
that
a
residue
of
the
canceled
or
suspended
pesticide
chemical
will
unavoidably
persist
in
the
environment
and
thereby
be
present
in
or
on
a
food,
the
Administrator
may
establish
a
tolerance
for
the
pesticide
chemical
residue.
In
establishing
such
a
tolerance,
the
Administrator
shall
take
into
account
both
the
factors
set
forth
in
subsection
(
b)(
2)
of
this
section
and
the
unavoidability
of
the
residue.
Subsection
(
e)
of
this
section
shall
apply
to
the
establishment
of
such
tolerance.
The
Administrator
shall
review
any
such
tolerance
periodically
and
modify
it
as
necessary
so
that
it
allows
no
greater
level
of
the
pesticide
chemical
residue
than
is
unavoidable.
(
5)
PESTICIDE
RESIDUES
RESULTING
FROM
LAWFUL
APPLICATION
OF
PESTICIDE.
CNotwithstanding
any
other
provision
of
this
chapter,
if
a
tolerance
or
exemption
for
a
pesticide
chemical
residue
in
or
on
a
food
has
been
revoked,
suspended,
or
modified
under
this
section,
an
article
of
that
food
shall
not
be
deemed
unsafe
solely
because
of
the
presence
of
such
pesticide
chemical
residue
in
or
on
such
food
if
it
is
shown
to
the
satisfaction
of
the
Secretary
thatC
(
A)
the
residue
is
present
as
the
result
of
an
application
or
use
of
a
pesticide
at
a
time
and
in
a
manner
that
was
lawful
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act;
and
(
B)
the
residue
does
not
exceed
a
level
that
was
authorized
at
the
time
of
that
application
or
use
to
be
present
on
the
food
under
a
tolerance,
exemption,
food
additive
regulation,
or
other
sanction
then
in
effect
under
this
chapter;
unless,
in
the
case
of
any
tolerance
or
exemption
revoked,
suspended,
or
modified
under
this
subsection
or
October
29,
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Page
53
of
91
subsection
(
d)
or
(
e)
of
this
section,
the
Administrator
has
issued
a
determination
that
consumption
of
the
legally
treated
food
during
the
period
of
its
likely
availability
in
commerce
will
pose
an
unreasonable
dietary
risk.
(
6)
TOLERANCE
FOR
USE
OF
PESTICIDES
UNDER
AN
EMERGENCY
EXEMPTION.
CIf
the
Administrator
grants
an
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136p)
for
a
pesticide
chemical,
the
Administrator
shall
establish
a
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
the
pesticide
chemical
residue.
Such
a
tolerance
or
exemption
from
a
tolerance
shall
have
an
expiration
date.
The
Administrator
may
establish
such
a
tolerance
or
exemption
without
providing
notice
or
a
period
for
comment
on
the
tolerance
or
exemption.
The
Administrator
shall
promulgate
regulations
within
365
days
after
August
3,
1996,
governing
the
establishment
of
tolerances
and
exemptions
under
this
paragraph.
Such
regulations
shall
be
consistent
with
the
safety
standard
under
subsections
(
b)(
2)
and
(
c)(
2)
of
this
section
and
with
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act.
(
m)
FEES.
C
(
1)
AMOUNT.
CThe
Administrator
shall
by
regulation
require
the
payment
of
such
fees
as
will
in
the
aggregate,
in
the
judgment
of
the
Administrator,
be
sufficient
over
a
reasonable
term
to
provide,
equip,
and
maintain
an
adequate
service
for
the
performance
of
the
Administrator's
functions
under
this
section.
Under
the
regulations,
the
performance
of
the
Administrator's
services
or
other
functions
under
this
section,
includingC
(
A)
the
acceptance
for
filing
of
a
petition
submitted
under
subsection
(
d)
of
this
section;
(
B)
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
or
establishing,
modifying,
leaving
in
effect,
or
revoking
an
exemption
from
the
requirement
for
a
tolerance
under
this
section;
(
C)
the
acceptance
for
filing
of
objections
under
subsection
(
g)
of
this
section;
or
(
D)
the
certification
and
filing
in
court
of
a
transcript
of
the
proceedings
and
the
record
under
subsection
(
h)
of
this
section;
may
be
conditioned
upon
the
payment
of
such
fees.
The
regulations
may
further
provide
for
waiver
or
refund
of
fees
in
whole
or
in
part
when
in
the
judgment
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purposes
of
this
subsection.
(
2)
DEPOSIT.
CAll
fees
collected
under
paragraph
(
1)
shall
be
deposited
in
the
Reregistration
and
Expedited
Processing
Fund
created
by
section
4(
k)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136a­
1(
k)).
Such
fees
shall
be
available
to
the
Administrator,
without
fiscal
year
limitation,
for
the
performance
of
the
Administrator's
services
or
functions
as
specified
in
paragraph
(
1).
(
n)
NATIONAL
UNIFORMITY
OF
TOLERANCES.
C
(
1)
"
QUALIFYING
PESTICIDE
CHEMICAL
RESIDUE"
DEFINED.
CFor
purposes
of
this
subsection,
the
term
means
a
pesticide
chemical
residue
resulting
from
the
use,
in
production,
processing,
or
storage
of
a
food,
of
a
pesticide
chemical
that
is
an
active
ingredient
and
thatC
(
A)
was
first
approved
for
such
use
in
a
registration
of
a
pesticide
issued
under
section
3(
c)(
5)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136a(
c)(
5))
on
or
after
April
25,
1985,
on
the
basis
of
data
determined
by
the
October
29,
2004
Page
54
of
91
Administrator
to
meet
all
applicable
requirements
for
data
prescribed
by
regulations
in
effect
under
that
Act
(
7
U.
S.
C.
136
et
seq.)
on
April
25,
1985;
or
(
B)
was
approved
for
such
use
in
a
reregistration
eligibility
determination
issued
under
section
4(
g)
of
that
Act
(
7
U.
S.
C.
136a­
1(
g))
on
or
after
August
3,
1996.
(
2)
"
QUALIFYING
FEDERAL
DETERMINATION"
DEFINED.
CFor
purposes
of
this
subsection,
the
term
"
qualifying
Federal
determination"
means
a
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
a
qualifying
pesticide
chemical
residue
thatC
(
A)
is
issued
under
this
section
after
August
3,
1996,
and
determined
by
the
Administrator
to
meet
the
standard
under
subsection
(
b)(
2)(
A)
(
in
the
case
of
a
tolerance)
or
(
c)(
2)
(
in
the
case
of
an
exemption)
of
this
section;
or
(
B)(
i)
pursuant
to
subsection
(
j)
of
this
section
is
remaining
in
effect
or
is
deemed
to
have
been
issued
under
this
section,
or
is
regarded
under
subsection
(
k)
of
this
section
as
exempt
from
the
requirement
for
a
tolerance;
and
(
ii)
is
determined
by
the
Administrator
to
meet
the
standard
under
subsection
(
b)(
2)(
A)
(
in
the
case
of
a
tolerance)
or
(
c)(
2)
(
in
the
case
of
an
exemption)
of
this
section.
(
3)
LIMITATION.
CThe
Administrator
may
make
the
determination
described
in
paragraph
(
2)(
B)(
ii)
only
by
issuing
a
rule
in
accordance
with
the
procedure
set
forth
in
subsection
(
d)
or
(
e)
of
this
section
and
only
if
the
Administrator
issues
a
proposed
rule
and
allows
a
period
of
not
less
than
30
days
for
comment
on
the
proposed
rule.
Any
such
rule
shall
be
reviewable
in
accordance
with
subsections
(
g)
and
(
h)
of
this
section.
(
4)
STATE
AUTHORITY.
CExcept
as
provided
in
paragraphs
(
5),
(
6),
and
(
8)
no
State
or
political
subdivision
may
establish
or
enforce
any
regulatory
limit
on
a
qualifying
pesticide
chemical
residue
in
or
on
any
food
if
a
qualifying
Federal
determination
applies
to
the
presence
of
such
pesticide
chemical
residue
in
or
on
such
food,
unless
such
State
regulatory
limit
is
identical
to
such
qualifying
Federal
determination.
A
State
or
political
subdivision
shall
be
deemed
to
establish
or
enforce
a
regulatory
limit
on
a
pesticide
chemical
residue
in
or
on
a
food
if
it
purports
to
prohibit
or
penalize
the
production,
processing,
shipping,
or
other
handling
of
a
food
because
it
contains
a
pesticide
residue
(
in
excess
of
a
prescribed
limit).
(
5)
PETITION
PROCEDURE.
C
(
A)
IN
GENERAL.
CAny
State
may
petition
the
Administrator
for
authorization
to
establish
in
such
State
a
regulatory
limit
on
a
in
or
on
any
food
that
is
not
identical
to
the
qualifying
Federal
determination
applicable
to
such
qualifying
pesticide
chemical
residue.
(
B)
PETITION
REQUIREMENTS.
CAny
petition
under
subparagraph
(
A)
shallC
(
i)
satisfy
any
requirements
prescribed,
by
rule,
by
the
Administrator;
and
(
ii)
be
supported
by
scientific
data
about
the
pesticide
chemical
residue
that
is
the
subject
of
the
petition
or
about
chemically
related
pesticide
chemical
residues,
data
on
the
consumption
within
such
State
of
food
bearing
the
pesticide
chemical
residue,
and
data
on
exposure
of
humans
within
such
State
to
the
pesticide
chemical
residue.
(
C)
AUTHORIZATION.
CThe
Administrator
may,
by
order,
grant
the
authorization
described
in
subparagraph
(
A)
if
the
Administrator
determines
that
the
October
29,
2004
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55
of
91
proposed
State
regulatory
limitC
(
i)
is
justified
by
compelling
local
conditions;
and
(
ii)
would
not
cause
any
food
to
be
a
violation
of
Federal
law.
(
D)
TREATMENT.
CIn
lieu
of
any
action
authorized
under
subparagraph
(
C),
the
Administrator
may
treat
a
petition
under
this
paragraph
as
a
petition
under
subsection
(
d)
of
this
section
to
modify
or
revoke
a
tolerance
or
an
exemption.
If
the
Administrator
determines
to
treat
a
petition
under
this
paragraph
as
a
petition
under
subsection
(
d)
of
this
section,
the
Administrator
shall
thereafter
act
on
the
petition
pursuant
to
subsection
(
d)
of
this
section.
(
E)
REVIEW.
CAny
order
of
the
Administrator
granting
or
denying
the
authorization
described
in
subparagraph
(
A)
shall
be
subject
to
review
in
the
manner
described
in
subsections
(
g)
and
(
h)
of
this
section.
(
6)
URGENT
PETITION
PROCEDURE.
CAny
State
petition
to
the
Administrator
pursuant
to
paragraph
(
5)
that
demonstrates
that
consumption
of
a
food
containing
such
pesticide
residue
level
during
the
period
of
the
food's
likely
availability
in
the
State
will
pose
a
significant
public
health
threat
from
acute
exposure
shall
be
considered
an
urgent
petition.
If
an
order
by
the
Administrator
to
grant
or
deny
the
requested
authorization
in
an
urgent
petition
is
not
made
within
30
days
of
receipt
of
the
petition,
the
petitioning
State
may
establish
and
enforce
a
temporary
regulatory
limit
on
a
in
or
on
the
food.
The
temporary
regulatory
limit
shall
be
validated
or
terminated
by
the
Administrator's
final
order
on
the
petition.
(
7)
RESIDUES
FROM
LAWFUL
APPLICATION.
CNo
State
or
political
subdivision
may
enforce
any
regulatory
limit
on
the
level
of
a
pesticide
chemical
residue
that
may
appear
in
or
on
any
food
if,
at
the
time
of
the
application
of
the
pesticide
that
resulted
in
such
residue,
the
sale
of
such
food
with
such
residue
level
was
lawful
under
this
section
and
under
the
law
of
such
State,
unless
the
State
demonstrates
that
consumption
of
the
food
containing
such
pesticide
residue
level
during
the
period
of
the
food's
likely
availability
in
the
State
will
pose
an
unreasonable
dietary
risk
to
the
health
of
persons
within
such
State.
(
8)
SAVINGS.
CNothing
in
this
chapter
preempts
the
authority
of
any
State
or
political
subdivision
to
require
that
a
food
containing
a
pesticide
chemical
residue
bear
or
be
the
subject
of
a
warning
or
other
statement
relating
to
the
presence
of
the
pesticide
chemical
residue
in
or
on
such
food.
(
o)
CONSUMER
RIGHT
TO
KNOW.
CNot
later
than
2
years
after
August
3,
1996,
and
annually
thereafter,
the
Administrator
shall,
in
consultation
with
the
Secretary
of
Agriculture
and
the
Secretary
of
Health
and
Human
Services,
publish
in
a
format
understandable
to
a
lay
person,
and
distribute
to
large
retail
grocers
for
public
display
(
in
a
manner
determined
by
the
grocer),
the
following
information,
at
a
minimum:
(
1)
A
discussion
of
the
risks
and
benefits
of
pesticide
chemical
residues
in
or
on
food
purchased
by
consumers.
(
2)
A
listing
of
actions
taken
under
subparagraph
(
B)
of
subsection
(
b)(
2)
of
this
section
that
may
result
in
pesticide
chemical
residues
in
or
on
food
that
present
a
yearly
or
lifetime
risk
above
the
risk
allowed
under
subparagraph
(
A)
of
such
subsection,
and
the
food
on
which
the
pesticide
chemicals
producing
the
residues
are
used.
(
3)
Recommendations
to
consumers
for
reducing
dietary
exposure
to
pesticide
chemical
October
29,
2004
Page
56
of
91
residues
in
a
manner
consistent
with
maintaining
a
healthy
diet,
including
a
list
of
food
that
may
reasonably
substitute
for
food
listed
under
paragraph
(
2).
Nothing
in
this
subsection
shall
prevent
retail
grocers
from
providing
additional
information.
(
p)
ESTROGENIC
SUBSTANCES
SCREENING
PROGRAM.
C
(
1)
DEVELOPMENT.
CNot
later
than
2
years
after
August
3,
1996,
the
Administrator
shall
in
consultation
with
the
Secretary
of
Health
and
Human
Services
develop
a
screening
program,
using
appropriate
validated
test
systems
and
other
scientifically
relevant
information,
to
determine
whether
certain
substances
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effect
as
the
Administrator
may
designate.
(
2)
IMPLEMENTATION.
CNot
later
than
3
years
after
August
3,
1996,
after
obtaining
public
comment
and
review
of
the
screening
program
described
in
paragraph
(
1)
by
the
scientific
advisory
panel
established
under
section
25(
d)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136w(
d))
or
the
science
advisory
board
established
by
section
4365
of
title
42,
the
Administrator
shall
implement
the
program.
(
3)
SUBSTANCES.
CIn
carrying
out
the
screening
program
described
in
paragraph
(
1),
the
Administrator
C
(
A)
shall
provide
for
the
testing
of
all
pesticide
chemicals;
and
(
B)
may
provide
for
the
testing
of
any
other
substance
that
may
have
an
effect
that
is
cumulative
to
an
effect
of
a
pesticide
chemical
if
the
Administrator
determines
that
a
substantial
population
may
be
exposed
to
such
substance.
(
4)
EXEMPTION.
CNotwithstanding
paragraph
(
3),
the
Administrator
may,
by
order,
exempt
from
the
requirements
of
this
section
a
biologic
substance
or
other
substance
if
the
Administrator
determines
that
the
substance
is
anticipated
not
to
produce
any
effect
in
humans
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen.
(
5)
COLLECTION
OF
INFORMATION.
C
(
A)
IN
GENERAL.
CThe
Administrator
shall
issue
an
order
to
a
registrant
of
a
substance
for
which
testing
is
required
under
this
subsection,
or
to
a
person
who
manufactures
or
imports
a
substance
for
which
testing
is
required
under
this
subsection,
to
conduct
testing
in
accordance
with
the
screening
program
described
in
paragraph
(
1),
and
submit
information
obtained
from
the
testing
to
the
Administrator,
within
a
reasonable
time
period
that
the
Administrator
determines
is
sufficient
for
the
generation
of
the
information.
(
B)
PROCEDURES.
CTo
the
extent
practicable
the
Administrator
shall
minimize
duplicative
testing
of
the
same
substance
for
the
same
endocrine
effect,
develop,
as
appropriate,
procedures
for
fair
and
equitable
sharing
of
test
costs,
and
develop,
as
necessary,
procedures
for
handling
of
confidential
business
information.
(
C)
FAILURE
OF
REGISTRANTS
TO
SUBMIT
INFORMATION.
C
(
i)
SUSPENSION.
CIf
a
registrant
of
a
substance
referred
to
in
paragraph
(
3)(
A)
fails
to
comply
with
an
order
under
subparagraph
(
A)
of
this
paragraph,
the
Administrator
shall
issue
a
notice
of
intent
to
suspend
the
sale
or
distribution
of
the
substance
by
the
registrant.
Any
suspension
proposed
under
this
paragraph
shall
become
final
at
the
end
of
the
30­
day
period
beginning
on
the
date
that
the
registrant
receives
the
notice
of
intent
to
suspend,
unless
during
that
period
a
October
29,
2004
Page
57
of
91
person
adversely
affected
by
the
notice
requests
a
hearing
or
the
Administrator
determines
that
the
registrant
has
complied
fully
with
this
paragraph.
(
ii)
HEARING.
CIf
a
person
requests
a
hearing
under
clause
(
i),
the
hearing
shall
be
conducted
in
accordance
with
section
554
of
title
5.
The
only
matter
for
resolution
at
the
hearing
shall
be
whether
the
registrant
has
failed
to
comply
with
an
order
under
subparagraph
(
A)
of
this
paragraph.
A
decision
by
the
Administrator
after
completion
of
a
hearing
shall
be
considered
to
be
a
final
agency
action.
(
iii)
TERMINATION
OF
SUSPENSIONS.
CThe
Administrator
shall
terminate
a
suspension
under
this
subparagraph
issued
with
respect
to
a
registrant
if
the
Administrator
determines
that
the
registrant
has
complied
fully
with
this
paragraph.
(
D)
NONCOMPLIANCE
BY
OTHER
PERSONS.
CAny
person
(
other
than
a
registrant)
who
fails
to
comply
with
an
order
under
subparagraph
(
A)
shall
be
liable
for
the
same
penalties
and
sanctions
as
are
provided
under
section
16
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2615)
in
the
case
of
a
violation
referred
to
in
that
section.
Such
penalties
and
sanctions
shall
be
assessed
and
imposed
in
the
same
manner
as
provided
in
such
section
16.
(
6)
AGENCY
ACTION.
CIn
the
case
of
any
substance
that
is
found,
as
a
result
of
testing
and
evaluation
under
this
section,
to
have
an
endocrine
effect
on
humans,
the
Administrator
shall,
as
appropriate,
take
action
under
such
statutory
authority
as
is
available
to
the
Administrator,
including
consideration
under
other
sections
of
this
chapter,
as
is
necessary
to
ensure
the
protection
of
public
health.
(
7)
REPORT
TO
CONGRESS.
CNot
later
than
4
years
after
August
3,
1996,
the
Administrator
shall
prepare
and
submit
to
Congress
a
report
containingC
(
A)
the
findings
of
the
Administrator
resulting
from
the
screening
program
described
in
paragraph
(
1);
(
B)
recommendations
for
further
testing
needed
to
evaluate
the
impact
on
human
health
of
the
substances
tested
under
the
screening
program;
and
(
C)
recommendations
for
any
further
actions
(
including
any
action
described
in
paragraph
(
6))
that
the
Administrator
determines
are
appropriate
based
on
the
findings.
(
q)
SCHEDULE
FOR
REVIEW.
C
(
1)
IN
GENERAL.
CThe
Administrator
shall
review
tolerances
and
exemptions
for
pesticide
chemical
residues
in
effect
on
the
day
before
August
3,
1996,
as
expeditiously
as
practicable,
assuring
thatC
(
A)
33
percent
of
such
tolerances
and
exemptions
are
reviewed
within
3
years
of
August
3,
1996;
(
B)
66
percent
of
such
tolerances
and
exemptions
are
reviewed
within
6
years
of
August
3,
1996;
and
(
C)
100
percent
of
such
tolerances
and
exemptions
are
reviewed
within
10
years
of
August
3,
1996.
In
conducting
a
review
of
a
tolerance
or
exemption,
the
Administrator
shall
determine
whether
the
tolerance
or
exemption
meets
the
requirements
of
subsections
(
b)(
2)
or
(
c)(
2)
of
this
section
and
shall,
by
the
deadline
for
the
review
of
the
tolerance
or
exemption,
issue
a
October
29,
2004
Page
58
of
91
regulation
under
subsection
(
d)(
4)
or
(
e)(
1)
of
this
section
to
modify
or
revoke
the
tolerance
or
exemption
if
the
tolerance
or
exemption
does
not
meet
such
requirements.
(
2)
PRIORITIES.
CIn
determining
priorities
for
reviewing
tolerances
and
exemptions
under
paragraph
(
1),
the
Administrator
shall
give
priority
to
the
review
of
the
tolerances
or
exemptions
that
appear
to
pose
the
greatest
risk
to
public
health.
(
3)
PUBLICATION
OF
SCHEDULE.
CNot
later
than
12
months
after
August
3,
1996,
the
Administrator
shall
publish
a
schedule
for
review
of
tolerances
and
exemptions
established
prior
to
August
3,
1996.
The
determination
of
priorities
for
the
review
of
tolerances
and
exemptions
pursuant
to
this
subsection
is
not
a
rulemaking
and
shall
not
be
subject
to
judicial
review,
except
that
failure
to
take
final
action
pursuant
to
the
schedule
established
by
this
paragraph
shall
be
subject
to
judicial
review.
(
r)
TEMPORARY
TOLERANCE
OR
EXEMPTION.
CThe
Administrator
may,
upon
the
request
of
any
person
who
has
obtained
an
experimental
permit
for
a
pesticide
chemical
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136
et
seq.)
or
upon
the
Administrator's
own
initiative,
establish
a
temporary
tolerance
or
exemption
for
the
pesticide
chemical
residue
for
the
uses
covered
by
the
permit.
Subsections
(
b)(
2),
(
c)(
2),
(
d),
and
(
e)
of
this
section
shall
apply
to
actions
taken
under
this
subsection.
(
s)
SAVINGS
CLAUSE.
CNothing
in
this
section
shall
be
construed
to
amend
or
modify
the
provisions
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2601
et
seq.)
or
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136
et
seq.)
October
29,
2004
Page
59
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
D
Final
Rule;
Time­
Limited
Tolerances
for
Pesticide
Emergency
Exemptions
(
65
FR
65125)
October
29,
2004
Page
60
of
91
ATTACHMENT
D
[
Federal
Register:
October
25,
2000
(
Volume
65,
Number
207)]
[
Rules
and
Regulations]
[
Page
64125­
64132]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr25oc00­
23]

[[
Page
64125]]
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Part
III
Environmental
Protection
Agency
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
40
CFR
Part
176
Time­
Limited
Tolerances
for
Pesticide
Emergency
Exemptions;
Final
Rule
[[
Page
64126]]
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
176
[
OPP­
181051A;
FRL­
6749­
7]
RIN
2070­
AD15
Time­
Limited
Tolerances
for
Pesticide
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Final
rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
This
final
rule
governs
the
establishment
of
time­
limited
tolerances
and
exemptions
for
residues
of
a
pesticide
chemical
resulting
from
its
emergency
use
as
authorized
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
The
purpose
of
this
rule
is
to
set
into
place
a
process
that
will
ensure
timely
decisions
on
any
tolerance
related
issue
in
response
to
a
request
for
an
emergency
use
of
a
pesticide
chemical
to
be
used
in
or
on
food
or
feed.
Under
this
rule,
EPA
will
implement
the
provisions
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
related
to
FIFRA
section
18
time­
limited
tolerances
by
evaluating
each
petition
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.
This
rule
pertains
only
to
regulatory
changes
resulting
from
the
1996
enactment
of
the
Food
Quality
Protection
Act
(
FQPA)
which
amended
FFDCA.

DATES:
This
rule
is
effective
November
24,
2000.
October
29,
2004
Page
61
of
91
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Joseph
E.
Hogue,
Office
of
Pesticide
Programs
(
7506C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308­
9072;
e­
mail
address:
hogue.
joe@
epa.
gov.
For
applicability
questions
contact:
Robert
Forrest,
Chief,
Minor
Use,
Inerts
and
Emergency
Response
Branch
(
7505C),
Registration
Division,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308­
9376;
e­
mail
address:
forrest.
robert@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
final
rule
if
you
are
the
Federal
government
or
a
State
or
Territorial
government
agency
charged
with
pesticide
authority.
Regulated
categories
and
entities
may
include,
but
are
not
limited
to:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Category
NAICS
codes
Examples
of
potentially
affected
entities
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Federal
government
9241
Federal
agencies
that
petition
EPA
for
FIFRA
section
18
use
authorization
State
or
Territorial
governments
States
or
territories
charged
with
pesticide
authority
that
petition
EPA
for
FIFRA
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
in
this
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
are
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
Sec.
176.1
or
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
October
29,
2004
Page
62
of
91
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
"
Laws
and
Regulations,"
"
Regulations
and
Proposed
Rules,"
and
then
look
up
the
entry
for
this
document
under
the
"
Federal
Register­­
Environmental
Documents."
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP­
181051A.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Room
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
Federal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.

II.
Background
A.
What
Action
is
the
Agency
Taking?

The
amendments
to
FFDCA,
as
prescribed
by
FQPA,
went
into
effect
immediately
upon
enactment
on
August
3,
1996.
Under
these
amendments,
EPA
is
required
to
conduct
all
pesticide
tolerance­
setting
activities,
including
those
approved
for
section
18
emergency
exemptions,
under
an
amended
FFDCA
section
408
with
a
new
safety
standard
and
new
regulatory
procedures.
In
the
Federal
Register
of
June
3,
1999
(
64
FR
29823)
(
FRL­
5750­
1),
EPA
published,
and
opened
for
public
comment,
proposed
regulations
for
setting
time­
limited
tolerances
for
section
18
emergency
exemptions.
In
its
proposal,
EPA
described
its
current
emergency
exemption
program
and
the
interim
practices
taken
to
evaluate
requests
for
section
18
tolerances
or
tolerance
exemptions,
and
to
establish
section
18
tolerances,
prior
to
the
issuance
of
this
final
rule.
In
the
time
period
spanning
from
August
1996
to
the
present,
EPA
has
been
evaluating
section
18
exemption
requests
and
issuing
associated
tolerances
or
tolerance
exemptions
on
a
case­
by­
case
basis.
These
evaluations
have
been
determined
based
on
materials
submitted
by
Federal
and
State
agencies
in
accordance
with
EPA
guidance
and
interim
procedures
sent
to
them
in
September
1996
and
further
elaborated
in
Pesticide
Registration
Notice
97­
1,
dated
January
1997,
which
[[
Page
64127]]

is
available
in
the
OPP
Docket
(
see
Unit
I.
B.
2).
This
non­
binding
interim
approach
to
current
section
18
tolerance
decisions
has
remained
in
place
while
the
Agency
has
developed
this
FFDCA
section
408(
l)(
6)
procedural
regulation.
October
29,
2004
Page
63
of
91
The
June
3,
1999
proposal
was
strictly
a
procedural
scheme
and
did
not
modify
any
regulatory
policies
associated
with
the
approval
of
the
emergency
exemption
itself
under
FIFRA.
EPA
proposed
to
establish
a
new
part
176
in
the
CFR
to
house
exclusively
regulations
governing
the
setting
of
time­
limited
tolerances
for
emergency
exemptions.
In
summary,
EPA
proposed
to:
1.
Review
data
for
establishing
a
time­
limited
tolerance
only
after
a
section
18
request
has
been
submitted;
2.
Evaluate
each
submission
individually
on
a
case­
by­
case
basis
to
determine
if
adequate
reliable
information
is
available
to
make
the
required
safety
finding;
3.
Not
routinely
require
additional
data
to
be
generated
and
instead
rely
on
submitted
data
already
reviewed
and
evaluated;
and
4.
Strive
to
make
a
regulatory
decision
in
a
timely
manner.
If
a
tolerance
could
not
be
established
then
the
emergency
exemption
would
not
be
granted.
Time­
limited
tolerances
would
typically
be
set
for
a
period
of
24
months
to
allow
the
treated
crop
from
the
previous
year's
emergency
application
to
clear
the
channels
of
trade.
In
addition
to
the
above
proposed
procedure,
EPA
solicited
comments
on
several
other
options
for
addressing
time­
limited
tolerances.
One
approach
was
to
require
a
full
data
set
to
support
section
18
tolerances
in
the
same
manner
as
is
required
for
the
establishment
of
permanent
tolerances.
EPA
also
considered
requiring
a
minimum
data
set
in
which
the
applicant
would
need
to
provide
a
specific
subset
of
the
data
normally
required
to
establish
a
permanent
tolerance.
Under
this
approach,
the
Agency
would
evaluate
only
those
defined
studies
in
making
its
safety
finding.
EPA
did
not
include
either
approach
as
its
primary
option
because
they
did
not
allow
for
timely
decisions.
Another
approach
for
setting
time­
limited
tolerances
was
suggested
by
the
National
Food
Processors'
Association.
If
this
approach
were
adopted,
EPA
would
not
conduct
a
full­
risk
assessment
for
a
section
18
tolerance,
but
would
instead
assess
the
incremental
risk
of
the
proposed
emergency
pesticide
use,
that
is,
the
amount
that
the
proposed
use
would
increase
dietary
risk
above
the
risk
from
existing
uses.

B.
What
is
the
Agency'sAuthority
for
Taking
this
Action?

Section
18
of
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
"
emergency
conditions
exist
which
require
such
exemption."
Regulations
regarding
EPA's
implementation
of
FIFRA
section
18
are
codified
in
40
CFR
part
166.
FQPA
amended
the
FFDCA
by
directing
EPA
to
establish
time­
limited
tolerances
or
tolerance
exemptions
for
pesticide
use
authorized
by
EPA
under
section
18
of
FIFRA
that
may
result
in
residues
in
or
on
food
or
feed.
Specifically
the
FFDCA
section
408(
l)(
6)
requires
EPA
to
establish
a
tolerance
or
exemption
from
the
requirement
of
a
tolerance
for
pesticide
chemical
residues
in
or
on
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption.
Section
408(
l)(
6)
also
requires
EPA
to
promulgate
regulations
governing
the
establishment
of
tolerances
and
tolerance
exemptions
for
pesticide
uses
approved
for
emergency
situations
under
FIFRA
section
18.
Section
408(
e)(
1)
authorizes
the
Administrator
to
establish,
modify,
suspend,
or
revoke
any
tolerance
or
exemption
from
the
requirement
of
a
tolerance
on
her
own
initiative,
and
to
establish
general
procedures
and
requirements
to
implement
section
408.
This
final
rule
is
issued
under
the
authority
of
sections
408(
e)(
1)(
c)
and
408(
l)(
6)
of
FFDCA,
as
amended
by
October
29,
2004
Page
64
of
91
FQPA.

III.
Public
Comment
and
EPA
Response
EPA
received
a
total
of
10
comments
in
response
to
its
proposed
rule.
Five
States,
two
growers
groups,
two
pesticide
manufacturing
companies,
and
one
public
interest
group
submitted
comments.
In
addition,
the
National
Food
Processors'
Association
attached
its
previously
submitted
petition
requesting
that
EPA
use
an
incremented
risk
approach
to
its
comments.
This
petition,
entitled
"
Petition
To
Issue
A
Regulation
Governing
Establishment
Of
Section
18
Tolerances,"
was
co­
sponsored
by
19
associated
grower
groups.
Everyone
expressed
support
of
EPA's
premise
that
timeliness
and
rapid
review
of
section
18
requests
is
the
essence
of
the
program.
In
this
regard,
all
parties
agreed
that
the
Agency
should
only
utilize
"
available
data
in
its
section
18
tolerance
reviews."
EPA,
in
addition
to
considering
changes
based
on
public
comments,
also
made
minor
changes
to
Sec.
Sec.
176.5
and
176.11(
a)
in
the
final
rule
to
clarify
the
provisions
and
to
conform
to
other
regulations
(
particularly
40
CFR
part
166).
EPA
has
also
changed
the
text
of
Sec.
176.3
slightly
by
changing
"
a
State,
U.
S.
Territory,
or
Federal
agency"
to
"
any
entity,
authorized
under
section
18
of
FIFRA
to
request
an
emergency
exemption,"
and
by
changing
"
declares"
a
crisis
exemption
to
"
issues."
A
similar
change
has
been
made
to
Sec.
176.15.
These
changes
will
eliminate
any
future
need
to
amend
these
rules
in
the
event
that
EPA's
regulations
or
FIFRA
are
ever
changed
so
that
an
entity
other
than
a
State,
U.
S.
Territory,
or
Federal
agency
would
be
allowed
to
request
an
emergency
exemption.
Other
changes
to
the
final
rule
were
made
as
discussed
in
this
unit.
Following
is
a
summary
of
the
significant
comments
received
by
EPA
and
its
response
to
these
comments.

A.
EPA
Should
Adopt
an
Incremental
Risk
Approach
to
Setting
Tolerances
for
Emergency
Exemptions
Eight
submitters
commented
on
the
approach
EPA
should
take
to
establish
time­
limited
tolerances
for
emergencies.
Two
commenters
agreed
with
EPA's
proposed
scheme
to
set
tolerances
on
a
case­
by­
case
basis
using
available,
reliable
information
to
make
the
required
safety
finding.
Six
commenters,
while
not
critical
of
EPA's
proposed
approach,
urged
the
Agency
to
instead
implement
an
accelerated
review
process
based
on
the
incremental
risk
of
the
emergency
use.
One
commenter
thought
that
the
minimum
data
set
approach
was
"
intriguing"
and
could
deserve
further
consideration.
This
approach,
it
was
stated,
had
the
potential
to
lend
clarity
and
objectivity
to
the
section
18
process
and
eliminate
the
need
for
the
Agency
to
use
"
best
judgement."
The
proponents
of
the
incremental­
risk
approach
argued
that
since
emergency
exemptions
are
by
their
very
nature
extreme
situations,
the
process
for
addressing
them
should
take
this
into
account
and
they
should
be
given
special
treatment.
Pesticide
use
in
an
emergency
is
for
a
short
term
and
generally
is
limited
to
a
single­
geographic
area,
therefore
there
is
less
exposure
to
the
pesticide
and
minimal
associated
risk.
One
commenter
noted
that
the
Agency's
policy
of
conducting
a
full­
risk
assessment
for
section
18
tolerances
does
not
consider
the
limited
scope
and
duration
of
the
use.
The
commenter
stated
that
performing
full
risk
assessments
each
time
a
October
29,
2004
Page
65
of
91
section
18
tolerance
is
requested
not
only
slows
down
the
entire
section
18
review
process,
but
also
diverts
Agency
resources.
According
to
the
commenter
[[
Page
64128]]

an
incremental­
risk
approach
would
eliminate
the
time
pressures
and
would
avoid
the
disruption
to
EPA's
base
pesticide
regulatory
programs.
In
spite
of
the
thoughtful
comments
on
the
fourth
option,
EPA
believes
that
the
case­
by­
case
approach
outlined
in
its
proposal
is
the
most
practical
approach
that
does
not
significantly
sacrifice
timeliness
or
efficiency
and
is
in
compliance
with
the
law.
It
allows
the
Agency
to
make
appropriate
decisions
quickly
while
fully
protecting
human
health,
especially
infants
and
children,
and
safeguarding
the
environment.
Moreover,
this
approach,
coupled
with
the
Agency's
newly
established
Threshold
of
Regulation
Policy
for
pesticide
tolerances
(
see
Unit
IV.)
may
resolve
many
concerns
expressed
by
those
who
favor
the
incremental­
risk
approach.
EPA
is
not
prepared
at
this
time
to
adopt
the
approach
suggested
by
the
commenters.
In
addition
to
presenting
difficult
legal
issues,
the
incremental­
risk
approach
may
not
be
needed
to
address
the
commenters'
concerns
regarding
purported
EPA
denial
of
section
18
emergency
exemption
petitions
or
a
lack
of
timely
review
by
the
Agency
of
such
petitions.
EPA's
initial
implementation
of
the
new
tolerance
requirement
necessitated
adjusting
Agency
procedures
and
involved
some
deviation
from
past
EPA
review
times
in
handling
section
18
emergency
exemption
requests.
Now
that
EPA
has
had
4
years
experience
in
setting
section
18
emergency
exemption
tolerances,
it
believes
that
it
has
adequately
adapted
the
emergency
exemption
process
to
deal
with
the
longer
lead­
time
inherent
in
the
requirement
for
establishment
of
these
tolerances.
Further,
as
noted
in
this
unit,
the
Agency's
newly
established
Threshold
of
Regulation
Policy
for
pesticide
tolerances
(
see
Unit
IV.)
may
address
many
of
the
commenters'
concerns.

B.
The
Timely
Establishment
of
a
Tolerance
After
Granting
an
Emergency
Exemption
is
Crucial
Several
commenters
said
that
EPA
should
establish
a
tolerance
at
the
time
of
the
section
18
approval.
The
underlying
concern
was
that
the
Agency
would
not
be
able
to
establish
a
tolerance
before
the
crop
is
harvested
or
the
commodity
enters
into
interstate
commerce.
One
person
remarked
that
in
addition
to
the
presence
of
an
emergency
condition,
growers
are
subject
to
increased
uncertainty
and
anxiety
the
longer
it
takes
the
Agency
to
establish
a
tolerance.
The
commenters
were
concerned
that
crops
treated
in
the
course
of
an
emergency
would
be
considered
adulterated
and
seized
for
the
lack
of
an
established
tolerance.
As
a
general
matter,
the
Agency
agrees
with
the
submitter.
For
new
pesticides,
the
Agency
grants
a
registration
and
establishes
the
required
tolerances
simultaneously.
However,
due
to
the
urgent
nature
of
pest
emergencies,
growers
need
to
be
able
to
lawfully
apply
a
pesticide
as
soon
as
possible
or
face
significant
economic
loss
for
that
year.
If
the
Agency
concludes
that
it
is
unable
to
establish
a
time­
limited
tolerance
for
that
use,
it
will
notify
the
applicant
immediately
so
that
some
other
method
of
control
for
the
emergency
pest
situation
can
be
sought.
EPA
often
has
to
balance
its
workload
between
establishing
tolerances
and
processing
section
18
requests.
During
peak
periods
for
emergency
exemption
requests,
resources
used
to
set
a
tolerance
could
result
in
the
delay
of
another
State's
section
18
application.
Nonetheless,
EPA
is
committed
to
working
October
29,
2004
Page
66
of
91
toward
the
goal
of
being
able
to
set
a
tolerance
at
the
same
time
as
granting
the
emergency
exemption.
For
example,
in
Fiscal
Year
(
FY)
1999,
EPA's
average
time
to
establish
a
tolerance
once
the
exemption
was
granted
was
66
days.
This
is
significantly
faster
than
the
average
of
87
days
it
took
the
Agency
in
FY
1998.
FFDCA
section
408(
l)(
5)
explains
the
conditions
upon
which
foods
and
feeds
may
be
subject
to
enforcement
action
due
to
pesticide
residues.
Under
this
subsection,
if
a
tolerance
is
no
longer
in
effect,
i.
e.,
it
has
been
revoked
or
has
expired,
the
crop
may
continue
to
be
marketed
if:
1.
The
crop
was
treated
with
an
approved
use
of
the
pesticide
at
the
time
of
treatment,
and
2.
The
level
of
the
residues
do
not
exceed
the
tolerance
in
effect
at
the
time
the
pesticide
was
applied.
In
the
second
instance,
it
is
important
to
note
that
the
tolerance
must
be
in
place
at
the
time
the
pesticide
is
used.
This
is
why
many
States
often
submit
section
18
emergency
exemption
requests
several
months
prior
to
the
onset
of
the
emergency
in
anticipation
of
the
2­
3
month
time
between
issuing
the
exemption
and
establishing
the
tolerance.
They
acknowledge
that
for
residues
resulting
from
the
use
to
be
considered
lawful
once
the
tolerance
has
expired,
the
tolerance
must
be
in
place
at
the
time
of
application,
not
the
time
of
harvest.
Nonetheless,
EPA's
policy
of
setting
tolerances
for
longer
duration
than
the
exemption
ensures
that
crops
treated
during
an
emergency
situation
should
lawfully
clear
trade
channels
while
the
tolerance
is
still
in
effect.

C.
All
Emergency
Exemptions
Issued
Under
Section
18
Should
Be
Covered
Under
the
"
Pipeline"
Provision
Many
of
those
who
submitted
comments
thought
that
the
"
pipeline"
provision
of
408(
l)(
5)
should
apply
to
exemptions
declared
under
crisis
situations.
The
"
pipeline"
can
be
described
as
those
crops
that
have
been
treated
legally
with
a
pesticide
that
are
still
in
the
channels
of
trade
when
the
tolerance
is
either
revoked
or,
as
in
the
case
of
an
emergency
exemption,
has
expired.
Those
who
commented
on
this
felt
that
although
a
tolerance
is
not
in
place
at
the
time
the
unregistered
pesticide
is
used,
since
the
pesticide
use
was
legal
under
FIFRA
section
18,
any
resulting
pesticide
residues
should
also
be
considered
legal
and
not
subject
to
enforcement
actions.
Crisis
exemptions
are
by
definition
unpredictable.
In
instances
where
an
emergency
condition
occurs
suddenly
and
there
is
no
time
to
formally
request
a
specific
emergency
exemption,
a
State
or
Federal
agency
may
issue
a
crisis
exemption
and
permit
the
use
of
an
unregistered
pesticide
(
40
CFR
166.40).
Under
a
crisis
exemption
a
pesticide
is
almost
always
used
in
the
field
prior
to
the
establishment
of
a
tolerance.
However,
this
situation
can
occur
for
specific
exemptions
as
well.
In
many
instances,
a
specific
exemption
request
(
especially
with
first­
time
tolerance
requests)
is
granted
and
the
pesticide
may
be
used
in
the
field
prior
to
the
establishment
of
the
time­
limited
tolerance,
where
appropriate.
EPA
later
conducts
a
full
review
and
establishes
the
time­
limited
tolerance.
If
the
time­
limited
tolerance
is
not
set
at
a
length
of
time
to
allow
for
crops
to
clear
trade
channels,
or
is
not
extended
and
therefore
expires,
commodities
treated
under
these
circumstances
could
be
adulterated
and
subject
to
seizure.
In
both
of
these
instances
the
"
pipeline"
provision
does
not
apply
because
a
tolerance
was
not
set
at
the
time
the
pesticide
is
applied.
The
statutory
requirement
of
FFDCA
section
408(
l)(
5)(
B)
is
not
met.
EPA
cannot
alter
the
requirements
in
the
FFDCA
through
regulations.
Nonetheless,
as
October
29,
2004
Page
67
of
91
noted
in
this
unit,
EPA's
policy
of
setting
tolerances
for
longer
duration
than
the
section
18
exemption
generally
ensures
that
crops
treated
during
an
emergency
situation
should
clear
trade
channels
while
the
tolerance
is
still
in
effect.
Some
commenters
expressed
concern
that
even
though
they
legally
applied
a
pesticide
under
a
crisis
emergency
exemption,
if
after
EPA
review
the
[[
Page
64129]]

necessary
tolerance
level
would
exceed
the
safety
standard
and
by
law
could
not
be
set,
their
entire
crop
could
be
subject
to
Federal
enforcement
measures.
To
avoid
this
potentially
dire
situation,
States
and
Federal
agencies
are
urged
to
consult
with
the
Agency
to
determine
whether
the
pesticide
in
question
has
particular
safety
issues
or
concerns
before
declaring
a
crisis.

D.
Time­
Limited
Tolerances
Should
Be
Set
for
Longer
Than
24
Months
A
few
commenters
thought
EPA
should
consider
establishing
time­
limited
tolerances
for
longer
than
2
years.
One
commenter
remarked
that
certain
exemptions
will
likely
be
needed
for
3
or
more
years
because
issues
such
as
new
pest
pressures
or
the
development
of
resistance
are
not
likely
to
go
away
once
they
have
appeared.
The
commenter
suggested
EPA
set
tolerances
for
3
years
upon
initially
granting
the
section
18
request
based
on
circumstances
which
are
likely
to
persist
over
several
years.
The
commenter
added
that
an
exemption
such
as
one
based
on
unusual
weather
patterns
probably
will
not
reoccur
in
succeeding
years
and
a
2­
year
tolerance
is
adequate
in
this
situation.
Under
EPA's
regulations,
specific
exemptions
and
public
health
exemptions
can
be
authorized
for
periods
of
up
to
1
year
(
40
CFR
166.28(
a)).
Since
actions
taken
under
this
section
are
intended
to
address
an
emergency
need
for
temporary
pest
relief,
most
section
18
exemptions
are
granted
for
one
growing
season.
In
the
preamble
to
the
proposed
rule,
EPA
stated
that
it
will
typically
set
a
time­
limited
tolerance
for
a
2­
year
period.
This
is
expected
to
allow
treated
crops
from
the
previous
year
to
clear
the
channels
of
trade.
The
Agency
is
flexible
on
this
point
and
may
set
time­
limited
tolerances
for
longer
time
periods
if
warranted.
In
addition,
EPA
may
modify
or
extend
a
time­
limited
tolerance
at
any
time
on
its
own
initiative
or
at
the
applicant's
request.
EPA
has
changed
Sec.
176.13
in
the
final
rule
to
clarify
that
it
may
extend
the
duration
of
a
tolerance
for
various
reasons.
EPA
strongly
recommends
that
if
an
applicant
believes
that
24
months
is
insufficient
for
a
time­
limited
tolerance,
the
applicant
should
request
a
more
appropriate
length
of
time
in
the
initial
section
18
request.
This
will
permit
the
Agency
to
judge
whether
a
longer
period
would
be
appropriate.
One
commenter
noted
that
in
the
proposed
regulatory
text,
the
words
"
unless
extended"
should
be
added
to
Sec.
176.11(
b)
to
be
consistent
with
the
language
in
Sec.
176.13.
Section
176.11(
b)
states
that
"(
b)
Tolerances
will
automatically
expire
and
be
revoked,
without
further
action
by
EPA,
at
the
time
set
out
in
the
Federal
Register
notice
establishing
the
tolerance."
EPA
agrees
with
this
suggestion
and
has
added
the
phrase
to
this
section.

E.
This
Rulemaking
Should
Be
Considered
a
"
Significant
Action"
that
Requires
OMB
Review
October
29,
2004
Page
68
of
91
Two
commenters
disagreed
with
the
determination
that
the
proposed
rule
was
not
a
"
significant
regulatory
action"
as
defined
under
section
3(
f)
of
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
and
stated
it
should
have
therefore
undergone
review
by
the
Office
of
Management
and
Budget
(
OMB),
and
that
the
final
rule
should
be
reviewed
by
OMB.
One
commenter
stated
that
emergency
exemptions
are
by
definition
"
of
economic
importance."
In
addition,
crop
losses
associated
with
emergency
exemptions
are
routinely
multi­
million
dollar
situations
and
that
individual
States
and
individual
growers
are
"
significantly"
impacted
by
a
cumbersome
tolerance
setting
process.
It
was
suggested
that
OMB
review
the
potential
impacts
associated
with
delays
in
establishing
tolerances.
E.
O.
12866
defines
as
"
significant"
a
regulatory
action
that
is
likely
to:
1.
Have
an
annual
effect
on
the
economy
of
$
100
million
or
more,
or
adversely
and
materially
affect
a
sector
of
the
economy;
productivity;
competition;
jobs;
the
environment;
public
health
or
safety;
or
State,
local,
or
tribal
governments
or
communities;
2.
Create
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;
3.
Materially
alter
the
budgetary
impacts
of
entitlements,
grants,
user
fees,
or
loan
programs;
or
4.
Raise
novel
legal
or
policy
issues.
The
determination
of
whether
or
not
a
regulatory
action
should
be
reviewed
by
OMB
under
E.
O.
12866
is
made
in
consultation
with
OMB.
Since
this
rule
is
a
procedural
rule
that
codifies
the
internal
process
by
which
EPA
will
set
emergency
tolerances,
OMB
determined
that
it
was
not
a
significant
regulatory
action
that
required
OMB
review
under
E.
O.
12866.
As
stated
in
the
proposal's
preamble,
EPA
estimates
that
the
direct
cost
of
this
rule
will
be
minimal
because
only
EPA
and
applicants
are
directly
affected,
and
this
action
does
not
require
applicants
to
submit
new
or
additional
information.
The
Agency
determined
that
this
rule,
once
promulgated,
is
not
expected
to
significantly
change
applicant
activities,
such
that
it
would
increase
the
current
burden
to
applicants
and
therefore
is
unlikely
to
have
a
major
economic
impact
on
the
States
or
Federal
agencies
that
apply
for
section
18
exemptions.
In
addition,
EPA
affirms
that
promulgation
of
this
rule
will
have
no
direct
impact
on
any
other
sector
of
the
economy,
or
on
any
other
government
entities,
programs,
or
policies.
A
copy
of
the
economic
analysis
is
available
in
the
public
version
of
the
official
record
for
this
rule
(
see
Unit
I.
B.
2.).

IV.
Is
a
Tolerance
Needed?

On
October
27,
1999,
EPA
published
in
the
Federal
Register
a
notice
of
availability
of
a
policy
entitled,
"
Threshold
of
Regulation
Policy­­
Deciding
Whether
a
Pesticide
With
a
Food
Use
Pattern
Requires
a
Tolerance"
(
64
FR
57881)
(
FRL­
6388­
2).
This
policy
pertains
to
the
use
of
a
pesticide
(
including
an
emergency
use)
on,
in,
or
near
food
which
does
not
result
in
residues
that
are
detectable
in
food.
EPA
is
adopting
this
policy
which
sets
forth
criteria
to
consider
in
evaluating
whether
there
is
no
"
need"
to
establish
a
tolerance,
i.
e.,
there
is
no
reasonable
expectation
of
finite
residues
of
the
pesticide
in
the
food.
If
the
criteria
are
met,
there
is
no
requirement
for
a
tolerance
or
tolerance
exemption.
The
Threshold
of
Regulation
policy
will
be
applicable
for
pesticide
uses
that
result
in
no
detected
residues
in
food
and
for
which
the
October
29,
2004
Page
69
of
91
degree
of
potential
risk
posed
by
any
theoretically
possible
residues
is
so
minimal
that
tolerance
setting
serves
no
purpose.
The
Threshold
of
Regulation
Policy
can
apply
to
time­
limited
tolerances
for
section
18
emergency
exemptions.
In
these
instances,
the
Agency
will
consider
surrogate
data
in
the
case
of
emergency
exemption
requests
where
all
the
data
needed
on
the
performance
of
the
analytical
method
or
the
magnitude
of
the
residue
as
determined
by
field
trial
studies
on
the
subject
commodity
are
unavailable.
Given
the
emergency
circumstances,
EPA
may
consider
accepting
data
from
a
different
crop
to
establish
eligibility
for
the
threshold
of
regulation.
Persons
wishing
a
Threshold
of
Regulation
policy
decision
should
make
the
request
in
writing
and
submit
materials
and
information
that
are
ordinarily
required
to
support
time­
limited
tolerances
or
tolerance
exemptions.

V.
Regulatory
Assessment
Requirements
A.
Executive
Order
12866
Pursuant
to
Executive
Order
12866,
entitled
Regulatory
Planning
and
[[
Page
64130]]

Review
(
58
FR
51735,
October
4,
1993),
it
has
been
determined
that
this
action
is
not
a
"
significant
regulatory
action"
and
is
therefore
not
subject
to
review
by
OMB.
OMB
has
made
this
determination
because
this
final
rule
is
a
procedural
rule
that
codifies
the
internal
process
by
which
EPA
will
set
emergency
tolerances.
Applicants
for
section
18
emergency
exemptions
(
i.
e.,
Federal
and
State
agencies)
are
the
only
parties,
other
than
EPA,
directly
affected
by
this
action.
According
to
the
economic
assessment
conducted
by
the
Agency,
the
applicants
of
section
18
emergency
exemptions
are
not
expected
to
experience
any
adverse
impacts
as
a
result
of
this
rule
because
the
rule
does
not
require
any
new
or
additional
data
from
applicants.
A
copy
of
the
economic
assessment
is
available
in
the
public
version
of
the
official
record
for
this
rule
(
see
Unit
I.
B.
2.).

B.
Regulatory
Flexibility
Act
Pursuant
to
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
this
regulatory
action
does
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Applicants
for
section
18
emergency
exemptions
are
U.
S.
States,
territories,
or
Federal
agencies
which,
by
definition,
are
not
small
entities
under
the
RFA.
Applicants
for
section
18
emergency
exemptions
are
the
only
parties,
other
than
EPA,
directly
affected
by
this
action.
Information
regarding
this
determination
will
be
provided
to
the
Chief
Counsel
for
Advocacy
of
the
Small
Business
Administration
(
SBA)
upon
request.

C.
Paperwork
Reduction
Act
October
29,
2004
Page
70
of
91
Pursuant
to
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
an
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
an
information
collection
request
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations,
after
appearing
in
the
preamble
of
the
final
rule,
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15,
and
included
on
the
related
collection
instrument.
This
regulatory
action
does
not
contain
any
new
information
collection
requirements
that
would
require
additional
OMB
review
and
approval.
The
information
collection
activities
related
to
the
procedures
for
emergency
exemptions
under
section
18
of
FIFRA,
which
are
contained
in
40
CFR
part
166,
are
already
approved
by
OMB
under
OMB
control
number
2070­
0032
(
EPA
ICR
No.
596),
and
the
process
and
informational
needs
for
requesting
that
the
Agency
establish
or
provide
an
exemption
from
the
establishment
of
a
tolerance
or
maximum­
residue
level
for
the
use
of
a
pesticide
on
food
or
feed
crops,
which
are
contained
in
40
CFR
part
180,
are
already
approved
by
OMB
under
OMB
control
number
2070­
0024
(
EPA
ICR
No.
597).
As
described
in
the
information
collection
instruments,
the
annual
respondent
burden
for
the
information
collection
activities
in
40
CFR
part
166
is
estimated
to
average
103
hours
per
application,
including
time
for
reading
the
regulations,
processing,
compiling
and
reviewing
the
requested
data,
generating
application
correspondence
or
summary
reports,
and
storing,
filing,
and
maintaining
the
data.
The
annual
respondent
burden
for
the
information
collection
activities
in
40
CFR
part
180
is
estimated
to
average
1,726
hours
per
petition,
including
time
for
reading
the
regulations,
processing,
compiling
and
reviewing
the
requested
data,
generating
the
request,
storing,
filing,
and
maintaining
the
data.
As
defined
by
the
PRA
and
5
CFR
1320.3(
b),
"
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.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.

D.
Environmental
Justice
Considerations
This
final
rule
does
not
involve
special
considerations
of
environmental­
justice
issues
pursuant
to
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994).
The
Agency
has
determined
that
this
final
rule
does
not
affect
the
environmental
and
health
conditions
in
low­
income
and
minority
communities
because
this
rule
codifies
the
internal
process
by
which
EPA
will
set
emergency
tolerances,
and
only
applies
to
applicants
for
section
18
emergency
exemptions
(
i.
e.,
Federal
and
State
agencies).
In
general,
low­
income
and
minority
communities
are
more
likely
to
benefit
from
the
risk
assessment
process
needed
for
the
establishment
of
tolerances
for
section
18
actions
that
might
impact
their
community.

E.
Unfunded
Mandates
Reform
Act
October
29,
2004
Page
71
of
91
Under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104­
4),
EPA
has
determined
that
this
action
does
not
contain
a
Federal
mandate
that
may
result
in
expenditures
of
$
100
million
or
more
for
State,
local,
and
tribal
governments,
in
the
aggregate,
or
the
private
sector
in
any
1
year.
As
applicants
for
section
18
emergency
exemptions,
Federal
and
State
agencies
are
the
only
parties,
other
than
EPA,
directly
affected
by
this
action.
The
potential
impact
on
State
agencies,
however,
is
expected
to
be
minimal
because
this
action
does
not
require
applicants
to
submit
new
or
additional
information.
In
addition,
EPA
has
determined
that
this
rule
does
not
significantly
or
uniquely
affect
small
governments.
Accordingly,
this
action
is
not
subject
to
the
requirements
of
sections
202,
203,
204,
and
205
of
UMRA.

F.
Federalism
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999),
requires
EPA
to
develop
an
accountable
process
to
ensure
"
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications."
"
Policies
that
have
federalism
implications"
is
defined
in
the
Executive
Order
to
include
regulations
that
have
"
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government."
This
final
rule
will
not
have
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132.
Since
this
rule
codifies
an
internal
process
for
the
Agency,
and
does
not
impose
requirements
on
others,
the
Agency
determined
that
this
rule
will
not
adversely
impact
the
entities
that
apply
for
section
18
exemptions.
The
process
established
by
this
final
rule
will
more
likely
benefit
applicants
and
others
by
establishing
an
effective
and
efficient
process
for
the
Agency
to
take
the
necessary
tolerance
actions
in
a
timely
manner.
Thus,
the
requirements
of
[[
Page
64131]]

section
6
of
the
Executive
Order
do
not
apply
to
this
rule.
Nevertheless,
the
Agency
provided
an
opportunity
for
Federal
and
State
agencies
to
review
and
provide
comments
on
the
proposed
process.
A
discussion
of
the
comments
EPA
received,
which
includes
comments
from
several
State
and
local
officials,
and
how
those
comments
are
addressed
in
the
final
rule,
is
provided
in
Unit
III.

G.
Consultation
and
Coordination
with
Indian
Tribal
Governments
Under
Executive
Order
13084,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
63
FR
27655,
May
19,1998),
EPA
may
not
issue
a
regulation
that
is
not
required
by
statute,
that
significantly
or
uniquely
affects
the
communities
of
Indian
tribal
governments,
and
that
imposes
substantial
direct
compliance
costs
on
those
communities,
unless
the
Federal
government
provides
the
funds
necessary
to
pay
the
direct
compliance
costs
incurred
by
the
tribal
governments.
This
final
rule
implements
requirements
specifically
set
forth
by
the
Congress
in
FFDCA
section
408(
l)(
6)
without
the
exercise
of
any
discretion
by
EPA.
The
final
rule
does
not
October
29,
2004
Page
72
of
91
significantly
or
uniquely
affect
the
communities
of
Indian
tribal
governments.
Accordingly,
the
requirements
of
section
3(
b)
of
Executive
Order
13084
do
not
apply
to
this
final
rule.

H.
Children's
Health
Protection
This
final
rule
is
not
subject
to
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
because
this
is
not
an
economically
significant
regulatory
action
as
defined
by
Executive
Order
12866
(
see
Unit
V.
A.).
In
addition,
this
final
rule
is
procedural
in
nature
and
does
not
involve
decisions
on
environmental
health
or
safety
risks
that
may
disproportionately
affect
children.

I.
National
Technology
Transfer
and
Advancement
Act
This
regulatory
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104­
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Section
12(
d)
directs
EPA
to
use
voluntary
consensus
standards
in
its
regulatory
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
business
practices,
etc.)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
The
NTTAA
requires
EPA
to
provide
Congress,
through
OMB,
explanations
when
the
Agency
decides
not
to
use
available
and
applicable
voluntary
consensus
standards.

J.
Civil
Justice
Reform
In
issuing
this
rule,
EPA
has
taken
the
necessary
steps
to
eliminate
drafting
errors
and
ambiguity,
minimize
potential
litigation,
and
provide
a
clear
legal
standard
for
affected
conduct,
as
required
by
section
3
of
Executive
Order
12988,
entitled
Civil
Justice
Reform
(
61
FR
4729,
February
7,
1996).

K.
Constitutionally
Protected
Property
Rights
EPA
has
complied
with
Executive
Order
12630,
entitled
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights
(
53
FR
8859,
March
15,
1988),
by
examining
the
takings
implications
of
this
rule
in
accordance
with
the
  
Attorney
General's
Supplemental
Guidelines
for
the
Evaluation
of
Risk
and
Avoidance
of
Unanticipated
Takings''
issued
under
the
Executive
Order.

VI.
Submission
to
Congress
and
the
General
Accounting
Office
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
October
29,
2004
Page
73
of
91
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
This
action
is
not
a
"
major
rule"
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
176
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
October
16,
2000.
Carol
M.
Browner,
Administrator.

Therefore,
40
CFR
chapter
I
is
amended
by
adding
new
part
176
to
read
as
follows:

PART
176­­
Time­
Limited
Tolerances
for
Emergency
Exemptions
Sec.
176.1
Scope
and
applicability.
176.3
Definitions.
176.5
Establishment
of
a
time­
limited
tolerance
or
exemption.
176.7
Information
needed
to
establish
a
tolerance.
176.9
Publication
of
a
tolerance.
176.11
Duration
of
a
tolerance.
176.13
Modification
of
a
time­
limited
tolerance.
176.15
Effect
of
a
tolerance.

Authority:
21
U.
S.
C.
346a
and
371.

Sec.
176.1
Scope
and
applicability.

This
part
describes
the
procedures
and
criteria
under
which
EPA
will
establish
time­
limited
tolerances
and
exemptions
from
the
requirement
of
a
tolerance
for
pesticide
chemical
residues
associated
with
use
of
pesticides
under
emergency
or
crisis
exemptions
under
FIFRA
section
18.
This
part
applies
only
to
tolerances
issued
on
the
initiative
of
EPA
as
the
result
of
the
issuance
of
an
emergency
exemption
or
the
declaration
of
a
crisis
exemption.
This
part
does
not
cover
time­
limited
tolerances
in
any
other
circumstances.

Sec.
176.3
Definitions.

The
terms
have
the
same
meaning
as
in
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
section
2,
and
in
the
Federal
Food,
Drug,
and
Cosmetic
Act
section
201
and
Sec.
166.3
of
October
29,
2004
Page
74
of
91
this
chapter.
In
addition,
the
following
terms
are
defined
for
the
purposes
of
this
part.
Agency
means
the
U.
S.
Environmental
Protection
Agency.
Applicant
means
any
entity
authorized
under
section
18
of
FIFRA
to
request
an
emergency
exemption
that
requests
such
an
exemption
under
Sec.
166.20
of
this
chapter,
or
issues
a
crisis
exemption
under
Sec.
166.40
of
this
chapter.
Crisis
exemption
means
an
exemption
authorized
under
FIFRA
section
18,
in
accordance
with
Sec.
Sec.
166.40
through
166.53
of
this
chapter.
Emergency
exemption
means
a
specific,
quarantine,
or
public
health
exemption
authorized
under
FIFRA
section
18
and
the
regulations
at
Sec.
Sec.
166.20
through
166.35
of
this
chapter.
EPA
means
the
U.
S.
Environmental
Protection
Agency.

[[
Page
64132]]

FFDCA
means
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
21
U.
S.
C.
321
et
seq.).
FIFRA
means
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C
136
et
seq.).
Tolerance
means
the
maximum
amount
of
a
pesticide
chemical
residue
that
may
lawfully
be
present
in
or
on
a
raw
agricultural
commodity,
or
processed
food,
or
animal
feed,
expressed
as
parts
per
million
by
weight
of
the
pesticide
chemical
residue
in
the
food
or
feed.
Tolerance
exemption
means
a
formal
determination
by
the
Agency
pursuant
to
FFDCA
section
408(
c),
21
U.
S.
C
346a(
c),
that
no
tolerance
is
needed
for
a
given
pesticide
chemical
residue
in
or
on
a
particular
food
commodity.
For
purposes
of
this
part,
the
term
"
tolerance"
shall
include
an
exemption
from
the
requirement
of
a
tolerance.

Sec.
176.5
Establishment
of
a
time­
limited
tolerance
or
exemption.

EPA
will
establish
a
time­
limited
tolerance
for
pesticide
chemical
residues
in
or
on
raw
or
processed
food
or
feed
resulting
from
the
use
of
a
pesticide
chemical,
if
EPA
authorizes
an
emergency
exemption
or
a
crisis
exemption.
EPA
will
consider
establishing
such
a
tolerance
only
if
an
applicant
acting
under
authority
of
FIFRA
section
18
either
has
requested
an
emergency
exemption,
has
stated
its
intention
to
issue
a
crisis
exemption,
or
has
issued
a
crisis
exemption
for
a
use
that
may
result,
directly
or
indirectly,
in
pesticide
chemical
residues
in
food
or
feed.

Sec.
176.7
Information
needed
to
establish
a
tolerance.

(
a)
EPA
will
establish
a
time­
limited
tolerance
only
if
EPA
can
determine
that
the
tolerance
is
safe,
that
is,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue.
EPA
will
base
its
determination
upon
data
submitted
by
the
applicant
and
other
readily
available
data.
If,
taking
into
account
the
limited
duration
and
emergency
nature
of
a
section
18
application,
and
based
on
the
available
data
the
Agency
cannot
conclude
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
the
use
proposed
by
the
applicant
or
granted
pursuant
to
a
crisis
exemption,
EPA
will
not
establish
a
tolerance.
(
b)
Data
and
other
relevant
information
to
support
the
establishment
of
a
time­
limited
tolerance
may
be
submitted
by
the
applicant,
or
by
any
other
person,
in
support
of
the
time­
limited
tolerance.
The
applicant
may
also
cite
relevant
data
previously
submitted
to
the
Agency.
October
29,
2004
Page
75
of
91
Sec.
176.9
Publication
of
a
tolerance.

(
a)
If
EPA
issues
an
emergency
exemption
or
crisis
exemption
under
FIFRA
section
18,
and
EPA
concludes
that
the
tolerance
for
residues
resulting
from
use
of
the
pesticide
under
the
exemption
will
be
safe,
then
EPA
will
establish
the
tolerance
by
publishing
an
amendment
to
40
CFR
part
180
in
the
Federal
Register.
(
b)
A
tolerance
under
this
part
may
be
established
without
prior
publication
of
a
proposed
tolerance
or
comment
period.

Sec.
176.11
Duration
of
a
tolerance.

(
a)
Tolerances
issued
under
this
part
will
become
effective
upon
publication
in
the
Federal
Register,
unless
otherwise
specified
by
the
Administrator.
(
b)
Unless
extended,
tolerances
will
automatically
expire
and
be
revoked,
without
further
action
by
EPA,
at
the
time
set
out
in
the
final
rule
published
in
Federal
Register.
(
c)
The
Administrator
may
revoke
a
tolerance
at
any
time
if
the
Administrator
determines
that
the
tolerance
is
no
longer
safe.

Sec.
176.13
Modification
of
a
time­
limited
tolerance.

If
additional
emergency
or
crisis
exemptions
are
authorized
that
would
extend
use
beyond
the
date
originally
authorized,
or
if
EPA
determines
that
the
duration
of
a
time­
limited
tolerance
is
insufficient
to
allow
treated
commodities
to
clear
the
channels
of
trade,
EPA
may
modify
the
time­
limited
tolerance
by
publication
of
a
final
rule
in
the
Federal
Register.
EPA
will
use
the
same
criteria
and
procedures
for
modification
as
for
establishing
tolerances
under
this
part.

Sec.
176.15
Effect
of
a
tolerance.

The
establishment
of
a
tolerance
under
this
part
does
not
alter
the
requirement
that
any
applicant
comply
with
procedures
established
in
part
166
of
this
chapter
for
emergency
exemptions
of
FIFRA.

[
FR
Doc.
00­
27405
Filed
10­
24­
00;
8:
45
am]
BILLING
CODE
6560­
50­
S
October
29,
2004
Page
76
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
E
Public
Comment
Received
Regarding
the
Proposed
Renewal
ICR
and
EPA
Response
to
Comment
October
29,
2004
Page
77
of
91
ATTACHMENT
E
Public
Comment:

>
jean
public
<
jeanpublic@
yahoo.
com>
>
10/
06/
2004
07:
13
AM
>
>
>
To:
Cameo
Smoot/
DC/
USEPA/
US@
EPA
>
cc:
rodney.
frelinghuysen@
mail.
house.
gov
>
Subject:
re:
public
comment
on
federal
register
of
8/
27/
04
vol
69
>
no
l66
page
52664
>
>
however,
regardless,
you
have
my
comments
on
this
>
proposal
below.
I
am
sorry
that
again
your
website
>
and
internet
connections
did
not
work.
this
happens
>
far
far
too
often.
>
>
>
­­­
Smoot.
Cameo@
epamail.
epa.
gov
wrote:
>
>
>
>
>
>
Dear
B
Sachau,
>
>
>
>
I
am
responding
to
your
e­
mail
of
9/
4/
04
send
>
>
to
Mr.
Martin
regarding
your
inability
to
down
load
>
>
a
copy
of
the
proposal
cited
in
the
federal
>
>
register
of
8/
27/
04
vol
69
no
l66
page
52664
>
>
regarding
the
Application
and
Summary
Report
for
an
>
>
Emergency
Exemption
for
Pesticides,
OMB
2070­
0032.
>
>
The
Agency
experienced
computer
systems
problems
>
>
when
posting
the
document
at
that
time.
However
on
>
>
9/
13/
04
we
were
able
to
finally
get
the
document
>
>
posted
for
public
comment.
The
public
comment
>
>
period
for
this
document
is
still
currently
open
>
>
until
10/
26/
04.
At
that
time
the
comment
period
>
>
will
end
to
allow
the
Agency
to
consolidate
and
>
>
respond
to
any
comments
received.
>
>
Please
note
that
a
second
comment
period
will
open
>
>
for
this
proposal
in
early
November
2004,
when
the
>
>
public
will
have
another
opportunity
to
comment
on
>
>
a
revised
version
of
the
proposed
document.
>
>
>
>
We
are
sorry
for
any
inconvenience
that
this
>
>
may
have
caused
and
we
hope
that
you
will
be
able
>
>
to
provide
comments
on
the
document
either
during
>
>
the
current
comment
period
or
in
the
next
comment
>
>
period.
>
>
>
>
Cameo
G.
Smoot
>
>
Policy
and
Regulatory
Services
Branch
(
7506C)
>
>
Office
of
Pesticide
Programs
>
>
United
States
Environmental
Protection
Agency
>
>
(
703)
305­
5454
>
>
(
703)
305­
5884
(
fax)
>
>
smoot.
cameo@
epa.
gov
>
>
>
>
>
>
>
>
jean
public
<
jeanpublic@
yahoo.
com>
October
29,
2004
Page
78
of
91
>
>
09/
04/
2004
07:
05
PM
>
>
>
>
To:
Nathanael
Martin/
DC/
USEPA/
US@
EPA
>
>
cc:
rodney.
frelinghuysen@
mail.
house.
gov
>
>
Subject:
public
comment
on
federal
register
of
>
>
8/
27/
04
vol
69
no
l66
page
52664
>
>
us
epa
opp
2004
0252
>
>
frl
7674­
6
exemptions
for
more
pesticides
>
>
>
>
i
oppose
and
object
to
this
proposal.
no
>
>
information
was
included
in
this
register
notice
so
>
>
it
should
be
reposted
with
a
90
day
comment
period.
>
>
>
>
>
>
b.
sachau
>
>
15
elm
st
>
>
florham
park
nj
07932
>
>
>
>
__________________________________
>
>
Do
you
Yahoo!?
>
>
Y!
Messenger
­
Communicate
in
real
time.
Download
>
>
now.
>
>
http://
messenger.
yahoo.
com
>
>
>
>
>
>
>
_______________________________
>
Do
you
Yahoo!?
>
Declare
Yourself
­
Register
online
to
vote
today!
>
http://
vote.
yahoo.
com
EPA
Response:

The
commenter
noted
that
the
supporting
information
was
not
immediately
available
in
electronic
format
via
E­
DOCKET
and
requested
that
EPA
provide
the
public
with
an
additional
90
days
to
comment
on
the
ICR.
EPA
did
not
extend
the
comment
period.
Although
an
electronic
version
of
the
ICR
had
not
yet
been
posted
to
the
online
electronic
docket,
the
ICR
was
available
in
the
official
public
docket.
Instructions
for
accessing
the
ICR
are
spelled
out
in
detail
in
the
Federal
Register
notice
that
sought
public
comment.

Federal
Register
notices
that
announce
the
intended
renewal
of,
and
an
opportunity
for
public
comment
regarding
any
of
EPA's
Pesticide
Program
ICRs
contain
detailed
instructions
on
how
to
obtain
copies
of
documents
cited
in
the
notice.
As
explained
in
the
Federal
Register
notice
for
this
ICR
renewal
(
see
p.
52665),
the
official
public
docket
 
which
consists
of
printed,
paper
copies
of
the
documents
specifically
referenced
in
the
Federal
Register
notice,
any
public
comments
received,
and
other
related
information
 
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1801
South
Bell
Street,
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.
Additionally,
a
contact
person
is
provided
in
each
Federal
Register
notice
who
is
available
to
provide
additional
assistance
when
electronic
web
versions
are
unavailable.
Upon
request
the
Agency
will
fax,
mail,
October
29,
2004
Page
79
of
91
or
e­
mail
the
public
version
of
the
official
record
to
members
of
the
public.

EPA
regrets
the
delay
in
providing
the
information
to
the
public
electronically
via
EDOCKET
EPA
noticed
that
E­
DOCKET
did
not
contain
the
information
shortly
after
the
Federal
Register
notice
published
and
rectified
the
situation
within
a
few
days.
However,
since
the
documents
were
available
to
the
public
in
the
official
docket
at
the
time
that
the
Federal
Register
notice
was
published,
an
extension
of
the
public
comment
period
was
not
necessary.
October
29,
2004
Page
80
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
F
Consultant
Contacts
for
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
&
Questions
Asked
EPA
During
Consultations
October
29,
2004
Page
81
of
91
ATTACHMENT
F
Consultation
Contacts
for
Application
and
Summary
Report
for
Emergency
Exemption
(
OMB
Control
no.
2070­
0032)

List
name,
address
and
phone
number
of
at
least
3
persons
(
entities
contacted)
whose
names
will
be
listed
in
the
ICR
document
David
Priebe,
State
Registration
Specialist
Janet
Fults,
Supervisor
Registration/
User
Certification
Oregon
Department
of
Agriculture
635
Capitol
Street,
NE
Salem,
OR
97310­
0110
Phone:
(
503)
986­
4656
Jim
Gray,
Pesticide
Registration
Coordinator
North
Dakota
Department
of
Agriculture
Pesticide
Division
600
E.
Boulevard,
Department
602
Bismarck,
North
Dakota
58505­
0020
Phone:
701­
328­
1505
Charlie
Clark,
Administrator
Pesticide
Registration
Section
Bureau
of
Pesticides,
Division
of
Agricultural
Environmental
Services
Florida
Department
of
Agriculture
and
Consumer
Services
3125
Conner
Boulevard
(
Building
#
6)
Tallahassee,
Florida
32399­
1650
Phone:
850­
921­
7798
October
29,
2004
Page
82
of
91
ATTACHMENT
F
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
(
OMB
2070­
0032)
EPA
Questions
asked
in
Consultation
(
1)
Publicly
Available
Data
$
Is
the
data
that
the
Agency
seeks
available
from
any
public
source,
or
already
collected
by
another
office
at
EPA
or
by
another
agency?

°
If
yes,
where
can
you
find
the
data?
(
Does
your
answer
indicate
a
true
duplication,
or
does
the
input
indicate
that
certain
data
elements
are
available,
but
that
they
don't
meet
our
data
needs
very
well?)

(
2)
Frequency
of
Collection
°
Can
the
Agency
collect
the
information
less
frequently
and
still
produce
the
same
outcome?

(
3)
Clarity
of
Instructions
°
The
ICR
is
intended
to
require
that
respondents
provide
certain
data
so
that
the
Agency
can
utilize
them.

°
Based
on
the
instructions
(
regulations,
PR
Notices,
etc.),
is
it
clear
what
you
are
required
to
do
and
how
to
submit
such
data?
If
not,
what
suggestions
do
you
have
to
clarify
the
instructions?

°
Do
you
understand
that
you
are
required
to
maintain
records?

$
Is
it
difficult
to
submit
information
in
ways
that
are
clear,
logical
and
easy
to
complete?

$
How
long
does
it
take
to
complete
an
application
package?

(
4)
Electronic
Reporting
and
Record
keeping
The
Government
Paperwork
Elimination
Act
requires
agencies
make
available
to
the
public
electronic
reporting
alternatives
to
paper­
based
submissions
by
2003,
unless
there
is
a
strong
reason
for
not
doing
so.

$
What
do
you
think
about
electronic
alternatives
to
paper­
based
records
and
data
submissions?
Current
electronic
reporting
alternatives
include
the
use
of
"
web
October
29,
2004
Page
83
of
91
forms"/
XML
based
submissions
via
the
Agency's
Internet
site
and
magnetic
mediabased
submissions,
e.
g.,
diskette,
CD­
ROM,
etc.
Would
you
be
interested
in
pursuing
electronic
reporting?

°
Are
you
keeping
your
records
electronically?
If
yes,
in
what
format?

Although
the
Agency
does
not
offer
an
electronic
reporting
option
because
of
CBI­
related
security
concerns
at
this
time,

$
What
benefits
would
electronic
submission
bring
you
in
terms
of
burden
reduction
or
greater
efficiency
in
compiling
the
information?

(
5)
Burden
and
Costs
$
Are
the
labor
rates
accurate?

$
The
Agency
assumes
there
are
no
capital
costs
associated
with
this
activity.
Is
that
correct?

$
Bearing
in
mind
that
the
burden
and
cost
estimates
include
only
burden
hours
and
costs
associated
with
the
paperwork
involved
with
this
ICR,
e.
g.,
the
ICR
does
not
include
estimated
burden
hours
and
costs
for
conducting
studies,
are
the
estimated
burden
hours
and
labor
rates
accurate?
If
you
provide
burden
and
cost
estimates
that
are
substantially
different
from
EPA's,
please
provide
an
explanation
of
how
you
arrived
at
your
estimates.

$
Are
there
other
costs
that
should
be
accounted
for
that
may
have
been
missed?
October
29,
2004
Page
84
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
G
Comments
Received
in
the
Consultation
Process
October
29,
2004
1
EPA
believes
this
statement
refers
to
certain
data
that
might
already
be
available
to
the
Agency
in
certain,
limited
circumstances
(
e.
g.,
data
that
was
previously
submitted
in
relationship
to
an
Experimental
Use
Permit).
In
such
cases,
the
Section
18
applicant
may
simply
cite
the
existing
data.
In
any
case,
the
applications
and
summary
reports
submitted
under
this
ICR
are
unique.

Page
85
of
91
ATTACHMENT
G
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
(
OMB
2070­
0032)
Comments
Received
in
the
Consultation
Process
(
1)
Publicly
Available
Data
°
Is
the
data
that
the
Agency
seeks
available
from
any
public
source,
or
already
collected
by
another
office
at
EPA
or
by
another
agency?

The
states
agreed
that
all
of
the
necessary
data
the
Agency
seeks
is
not
available
anywhere
else.
Pieces
of
information
can
be
pulled
or
borrowed
from
other
sources,
but
each
section
18
package
submitted
is
unique.

OR
The
collection
of
information
in
a
section
18
package
is
unique
to
the
EPA
Minor
Use,
Inerts,
&
Emergency
Response
Branch.
Certain
portions
of
the
whole
section
18
package
data
set
may
have
been
collected
by
another
EPA
office
for
purposes
other
than
a
section
18
application.
This
would
be
especially
true
for
section
18
applications
involving
unregistered
products.
1
Our
section
18
packages
usually
cite
data
already
available
within
EPA,
rather
than
causing
a
duplicative
data
collection
situation.
ND
For
regional
requests,
data
is
already
collected
by
another
office.
FL
Some
data
the
Agency
seeks
is
available
from
internet
searches.

°
If
yes,
where
can
you
find
the
data?
(
Does
your
answer
indicate
a
true
duplication,
or
does
the
input
indicate
that
certain
data
elements
are
available,
but
that
they
don't
meet
our
data
needs
very
well?)

OR
Data
from
IR­
4
is
often
utilized
and
submitted
with
the
application.
ND
Data
from
agricultural
statistics
and
from
extension
agencies
is
used
to
support
the
request.
FL
Data
from
the
University
of
Florida
and
commodity
groups
is
utilized
and
submitted
in
support
of
the
emergency
exemption
request.

(
2)
Frequency
of
Collection
°
Can
the
Agency
collect
the
information
less
frequently
and
still
produce
the
same
October
29,
2004
Page
86
of
91
outcome?

OR
Case
by
case
is
okay.
There
are
some
situations
where
the
information
is
similar
from
year­
to­
year
and
there
is
little
change
in
economic
data,
alternative
pesticides,
target
pests,
or
the
amount
of
acreage.
These
generalities
can
be
used
to
lump
information
together
over
three
years
and
still
produce
the
same
outcome.
However,
other
18s
require
much
more
information
especially
when
the
risk
cup
picture
for
a
pesticide
changes.
ND
No,
economic
data
can
change
as
well
as
management
practices
and
alternatives
used.
ND
prefers
each
year
that
a
renewal
request
is
submitted
to
Agency
FL
Yes,
specifically
for
repeat
requests,
information
can
be
collected
every
third
year
and
produce
the
same
outcome.

(
3)
Clarity
of
Instructions
°
The
ICR
is
intended
to
require
that
respondents
provide
certain
data
so
that
the
Agency
can
utilize
them.

°
Based
on
the
instructions
(
regulations,
PR
Notices,
etc.),
is
it
clear
what
you
are
required
to
do
and
how
to
submit
such
data?
If
not,
what
suggestions
do
you
have
to
clarify
the
instructions?

OR
Generally,
the
instructions
are
clear.
However,
an
updated
guidance
document
for
section
18
requests
would
be
useful.
ND
Yes,
the
instructions
are
clear.
The
section
18
team
provides
an
annual
heads­
up
letter
and
updated
contact
information,
which
is
very
useful.
FL
Yes,
the
instructions
are
clear.

°
Do
you
understand
that
you
are
required
to
maintain
records?

OR
Yes
ND
Yes
FL
Yes
°
Is
it
difficult
to
submit
information
in
ways
that
are
clear,
logical
and
easy
to
complete?

OR
Yes,
we
struggle
with
gathering
and
presenting
risk
information.
Guidance
has
not
been
revised
under
FQPA.
Reasonable
ESA
guidance
would
be
useful
because
section
7
consultations
are
becoming
more
litigious.
ND
No,
it
is
the
burden
of
the
state
lead
agency
to
make
the
argument
clear.
FL
No,
it
is
not
difficult
to
submit
information
in
ways
that
are
clear,
logical
and
easy
to
submit.

°
How
long
does
it
take
to
complete
an
application
package?
October
29,
2004
Page
87
of
91
OR
To
complete
a
repeat
request
is
a
lot
simpler.
It
takes
5­
20
hours.
For
a
new
emergency
exemption
request,
it
takes
1­
2
weeks.
ND
A
section
18
renewal
can
take
as
little
as
a
half
a
day
to
complete.
From
the
time
a
new
request
is
received,
it
takes
between
3
weeks
and
3
months
to
complete.
FL
A
new
request
takes
2.5
weeks
or
about
100
hours
and
a
renewal
takes
approximately
1
week
or
about
50
hours
to
complete.
In
Florida,
the
emergency
exemption
applications
must
be
reviewed
by
several
administrative
levels.

(
4)
Electronic
Reporting
and
Record
keeping
The
Government
Paperwork
Elimination
Act
requires
agencies
make
available
to
the
public
electronic
reporting
alternatives
to
paper­
based
submissions,
unless
there
is
a
strong
reason
for
not
doing
so.

°
What
do
you
think
about
electronic
alternatives
to
paper­
based
records
and
data
submissions?
Current
electronic
reporting
alternatives
include
the
use
of
"
web
forms"/
XML
based
submissions
via
the
Agency's
Internet
site
and
magnetic
media­
based
submissions,
e.
g.,
diskette,
CD­
ROM,
etc.
Would
you
be
interested
in
pursuing
electronic
reporting?

OR
We
are
supportive
of
internet­
based
access.
Currently
we
use
Macintosh
and
it
is
difficult
to
receive
information
form
outside
agencies.
ND
We
are
in
favor
of
electronic
alternatives
to
paper­
based
records.
This
method
makes
government
more
efficient
and
transparent.
FL
We
support
electronic
alternatives
to
paper­
based
records.
However,
we
are
likely
to
encounter
some
resistance
from
interested
parties,
growers
and
consumers
as
we
attempt
the
transition
from
paper­
based
records
and
data
submissions.

°
Are
you
keeping
your
records
electronically?
If
yes,
in
what
format?

OR
We
keep
paper
and
electronic
formats.
We
use
Word
­
MAC­
based.
ND
We
keep
records
in
electronic
format.
FL
We
do
not
keep
records
in
electronic
format.

Although
the
Agency
does
not
offer
an
electronic
reporting
option
because
of
CBI­
related
security
concerns
at
this
time,

°
What
benefits
would
electronic
submission
bring
you
in
terms
of
burden
reduction
or
greater
efficiency
in
compiling
the
information?

OR
We
are
definitely
in
support
of
electronic
submissions
because
it
is
easier
to
update
(
reduces
time)
repeat
renewal
applications.
ND
The
benefits
are
reduced
shipping
costs,
greater
tracking,
and
greater
transparency.
October
29,
2004
Page
88
of
91
FL
A
benefit
of
electronic
submission
would
be
a
reduction
in
the
huge
burden
to
scan
paper.

(
5)
Burden
and
Costs
°
Are
the
labor
rates
accurate?

OR
Labor
rates
in
the
ICR
might
accurately
reflect
the
national
average;
however,
rates
in
Oregon
are
a
bit
lower.
ND
Labor
rates
in
ND
are
lower
than
the
ICR/
national
average.
FL
Labor
rates
are
well
within
the
range
that
is
being
paid
in
Florida.

°
The
Agency
assumes
there
are
no
capital
costs
associated
with
this
activity.
Is
that
correct?

OR
Yes,
there
are
no
capital
costs
associated
with
this
activity.
ND
Yes,
there
are
no
capital
costs
associated
with
this
activity.
FL
Yes,
there
are
no
capital
costs
associated
with
this
activity.

°
Bearing
in
mind
that
the
burden
and
cost
estimates
include
only
burden
hours
and
costs
associated
with
the
paperwork
involved
with
this
ICR,
e.
g.,
the
ICR
does
not
include
estimated
burden
hours
and
costs
for
conducting
studies,
are
the
estimated
burden
hours
and
labor
rates
accurate?
If
you
provide
burden
and
cost
estimates
that
are
substantially
different
from
EPA's,
please
provide
an
explanation
of
how
you
arrived
at
your
estimates.

OR
Estimated
burden
hours
and
labor
rates
are
accurate
ND
Estimates
are
pretty
accurate
FL
Do
not
have
cost
burdens
that
are
vastly
different
°
Are
there
other
costs
that
should
be
accounted
for
that
may
have
been
missed?

OR
Yes,
outreach
programs
to
educate
and
inform
growers
about
the
section
18
process
should
be
accounted
for
as
well
as
costs
to
pay
extension
agents
to
review
packages.
ND
Yes,
there
is
no
clerical
support
in
state
government.
FL
None
­
any
costs
involved
are
part
of
the
internal
pesticide
program
costs,
which
is
part
of
one
of
the
6
or
7
operations
Florida
performs.
October
29,
2004
Page
89
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
H
EPA
Form
No.
8570­
4
Confidential
Statement
of
Formula
This
attachment
is
only
available
electronically
as
a
PDF
file.
You
may
easily
access
the
file
in
EDOCKET,
the
electronic
version
of
the
public
docket
http://
www.
epa.
gov/
edocket.
Once
in
the
system,
select
"
Quick
Search"
under
the
heading
"
Go
Directly
to
EDOCKET"
in
the
left
navigational
menu.
Next,
search
by
Docket
and
enter
in
the
following
docket
ID
number
in
the
field
provided:
"
OPP­
2004­
0252".
Then,
search
the
docket
index
for
the
document
by
title.
If
you
have
any
difficulties,
please
contact
the
technical
person
listed
in
the
Federal
Register
notice
announcing
the
submission
of
this
ICR
to
OMB
for
review
and
approval.
The
form
is
also
available
electronically
via
the
Internet
at
http://
www.
epa.
gov/
opprd001/
forms/
8570­
4.
pdf
October
29,
2004
Page
90
of
91
Application
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides
OMB
No.
2070­
0032
EPA
No.
0596.08
Attachment
I
Display
Related
to
OMB
Control
No.
2070­
0032
Listings
of
Related
Regulations
in
40
CFR
9.1
October
29,
2004
Page
91
of
91
ATTACHMENT
I
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