1
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
Identification
of
the
Information
Collection
1(
a).
Title
of
the
Information
Collection
Title:
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients
EPA
ICR
No.
0597.09
OMB
Control
No.
2070­
0024
1(
b).
Short
Characterization/
Abstract
The
use
of
pesticides
to
increase
crop
production
often
results
in
pesticide
residues
in
or
on
the
crop.
To
protect
the
public
health
from
unsafe
pesticide
residues,
the
Environmental
Protection
Agency
(
EPA)
sets
limits
on
the
nature
and
level
of
residues
permitted
pursuant
to
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
(
Attachment
A).
A
pesticide
may
not
be
used
on
food
or
feed
crops
unless
the
Agency
has
established
a
tolerance
(
maximum
residue
limit)
for
the
pesticide
residues
on
that
crop,
or
established
an
exemption
from
the
requirement
to
have
a
tolerance.

Under
the
law,
EPA
is
responsible
for
ensuring
that
the
maximum
residue
levels
likely
to
be
found
in
or
on
food/
feed
are
safe
for
human
consumption
through
a
careful
review
and
evaluation
of
residue
chemistry
and
toxicology
data.
In
addition,
EPA
must
ensure
that
adequate
enforcement
of
the
tolerance
can
be
achieved
through
the
testing
of
submitted
analytical
methods.
If
the
data
are
adequate
for
EPA
to
determine
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure,
the
Agency
will
establish
the
tolerance
or
grant
an
exemption
from
the
requirement
of
a
tolerance.

There
are
basically
three
types
of
tolerance
actions:

(
1)
Permanent
tolerance
(
or
an
exemption
from
the
requirement
for
a
permanent
tolerance)
for
residues
which
would
result
from
a
pesticide
use
registered
under
FIFRA.
These
tolerances
can
be
established
for
raw
and
processed
foods
and
they
can
address
both
active
and
inert
ingredients
in
pesticides.
The
vast
majority
of
these
actions
are
taken
in
response
to
petitions,
but
the
Agency
may
also
initiate
such
actions.

(
2)
Temporary
tolerance
(
or
an
exemption
from
the
requirement
for
a
temporary
tolerance)
to
permit
the
sale
of
commodities
containing
residues
resulting
from
authorized
experimental
use
of
an
unregistered
pesticide.
In
the
absence
of
such
a
tolerance
or
exemption,
all
such
commodities
must
be
destroyed.
In
submitting
an
application
for
Experimental
Use
Permit
(
EUP),
the
applicant
may
also
request
that
the
Agency
establish
a
tolerance
or
an
exemption
from
the
tolerance
requirement.
This
ICR
does
not
cover
EUP
related
tolerance
information
collection
activities,
which
are
covered
by
the
ICR
entitled,
AApplication
for
Experimental
Use
Permit
(
EUP)
to
Ship
and
Use
a
Pesticide
for
Experimental
Purposes
Only@
(
OMB
Control
#
2070­
0040,
EPA
ICR
No.
276).
2
(
3)
Time­
limited
tolerance
(
or
an
exemption
there
from)
to
permit
the
sale
of
commodities
containing
residues
resulting
from
a
pesticide
whose
use
was
authorized
under
Section
18
of
FIFRA.
Under
FIFRA
'
18,
EPA
may
allow
States
to
use
a
pesticide
for
an
unregistered
use
for
a
limited
time
if
EPA
determines
that
emergency
conditions
exist.
FQPA
requires
EPA
to
establish
tolerances
to
cover
all
pesticide
residues
in
food,
even
residues
resulting
from
emergency
uses.
Although
the
Agency
initiates
these
tolerance
actions,
these
actions
are
taken
in
response
to
petitions
for
the
Agency
to
issue
an
action
under
FIFRA
'
18.
This
ICR
does
not
cover
information
collection
related
to
FIFRA
'
18
tolerance
activities,
which
is
collected
under
the
ICR
entitled,
AApplication
and
Summary
Report
for
an
Emergency
Exemption
for
Pesticides@
(
OMB
Control
#
2070­
0032,
EPA
ICR
No.
596).

This
ICR
only
applies
to
the
information
collection
activities
associated
with
the
submission
of
a
petition
for
a
tolerance
action.
While
EPA
is
authorized
to
set
pesticide
tolerances,
the
Food
and
Drug
Administration
(
FDA)
is
responsible
for
their
enforcement.
Food
or
feed
commodities
found
to
contain
pesticide
residues
in
excess
of
established
tolerances
are
considered
adulterated,
and
are
subject
to
seizure
by
FDA,
and
may
result
in
civil
penalties.

2.
Need
For
and
Use
of
the
Collection
2(
a).
Need/
Authority
for
the
Collection
The
tolerances
for
pesticide
residues
in
food
or
feed
are
set
primarily
under
the
authority
of
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended.
The
Agency
takes
these
tolerance
actions
either
on
its
own
initiative
pursuant
to
FFDCA
'
408(
e)
or
in
response
to
a
petition
filed
pursuant
to
FFDCA
'
408(
d).
The
regulations
covering
tolerances
are
contained
in
Title
40
of
the
Code
of
Federal
Regulations
(
CFR)
Part
180.
Actual
listings
of
individual
tolerances
by
chemical
are
also
found
in
Part
180
(
Attachment
B).

Under
FFDCA
'
408(
d),
any
person
may
file
a
petition
with
EPA,
proposing
the
issuance
of
a
regulation
establishing,
modifying,
or
revoking
(
a)
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food,
or
(
b)
an
exemption
from
the
requirement
to
have
a
tolerance
for
such
residue.
The
Agency
publishes
a
notice
of
receipt
for
such
petitions
in
order
to
provide
an
opportunity
for
public
comment
on
the
request,
and
then
either
issues
a
final
regulation,
or
a
notice
denying
the
petitioner=
s
request.
FFDCA
'
408(
d)(
4)
directs
the
Agency
to
issue
a
final
regulation
establishing,
modifying,
or
revoke
a
tolerance
for
the
pesticide
chemical
residue
or
an
exemption
of
the
pesticide
chemical
residue
from
the
requirement
of
a
tolerance,
or
issue
an
order
denying
the
petition.

Under
FFDCA
'
408(
e),
at
any
time
the
Agency
may
issue
a
regulation
establishing,
modifying,
suspending,
or
revoking
(
a)
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food,
or
(
b)
an
exemption
from
the
requirement
to
have
a
tolerance
for
such
residue.
When
initiating
such
actions,
FFDCA
'
408(
e)(
2)
requires
the
Agency
to
issue
a
notice
of
proposed
rulemaking
to
provide
an
opportunity
for
public
comment.
3
The
Food
Quality
Protection
Act
of
1996
(
FQPA),
which
amended
the
two
primary
statutes
regulating
pesticides,
i.
e.,
FFDCA
and
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA),
requires
that
tolerances
be
set
at
a
level
to
ensure
that
there
be
Aa
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure.@
Among
other
things,
FQPA
requires
EPA
to
consider
a
number
of
factors
when
setting
such
tolerances
or
registering
pesticide
products,
including:

(
1)
special
protection
for
infants
and
children;

(
2)
aggregate
exposure
and
risk
from
foods
and
other
known
sources,
such
as
drinking
water
and
household
pesticide
use;

(
3)
consideration
of
common
mechanisms
of
toxicity
(
some
chemicals
have
different
molecular
structures
but
cause
deleterious
effects
in
the
same
manner);
and,

(
4)
consideration
of
endocrine
disruptor
effects.

The
collection
of
information
covered
by
this
ICR
is
needed
to
ensure
that
the
statutory
requirements
related
to
tolerances
can
be
met
by
the
public
and
EPA.
Food
or
feed
commodities
found
to
contain
residues
of
a
pesticide
without
or
in
excess
of
established
tolerances
are
considered
adulterated,
and
are
subject
to
seizure
by
FDA,
and
may
result
in
civil
penalties.

2(
b).
Practical
Utility/
Users
of
the
Data
The
FQPA
directs
the
Agency
to
consider
aggregate
exposures
from
dietary
and
nonoccupational
sources
when
assessing
the
risks
of
a
chemical
and
setting
tolerances.
In
addition
to
dietary
exposure,
such
sources
as
drinking
water
and
residential
lawn
care
use
need
to
be
considered.
EPA
must
make
the
statutory
determination
that
the
resulting
pesticide
residues
in
food
or
feed
will
result
in
a
reasonable
certainty
of
no
harm
effects
of
human
health
from
aggregate
exposure
through
dietary,
non­
occupational,
and
drinking
water
routes
of
exposure
before
establishing
the
tolerance.

EPA
is
applying
the
FQPA
standard
to
all
tolerances
for
newly­
registered
chemicals
and
food
uses.
In
addition,
FQPA
has
set
a
schedule
for
reassessing
all
10,000
existing
tolerances
under
this
new
standard
by
2006.
FQPA
did
not
provide
for
a
phase­
in
period
for
many
of
the
new
requirements
which
had
not
previously
been
a
part
of
EPA=
s
risk
assessment
process.

EPA
does
not
require
registrants
to
submit
any
additional
information
under
this
ICR
in
order
for
the
Agency
to
determine
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure.
However,
Section
408
of
FFDCA
requires
petitioners
submit
Aan
information
summary
of
the
petition
and
of
the
data,
information
and
arguments
submitted
or
cited
in
support
of
the
petition.@
FQPA
requires
EPA
to
consider
additional
information
in
order
to
make
the
necessary
regulatory
decisions.
Shortly
after
the
enactment
of
FQPA,
EPA
encouraged
petitioners
who
previously
submitted
data
prior
to
enactment
of
the
law
to
supplement
their
original
submissions
with
additional
information
to
aid
the
Agency=
s
decisionmaking
process
in
light
of
its
new
statutory
mandates.
To
allow
for
the
most
efficient
processing
and
review
of
tolerance
petitions,
the
Agency
provided
a
description
of
the
types
of
information
4
that
EPA
considers
helpful
in
the
appendices
to
Pesticide
Registration
(
PR)
Notice
No.
97­
1
(
Attachment
D).
1
EPA
continues
to
encourage
petitioners
to
submit
supplemental
information
with
their
petitions
to
help
EPA
determine
whether
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure.

EPA
uses
the
data
to
make
decisions
about
the
tolerance
petitions.
The
Agency=
s
risk
managers
review,
among
other
things,
the
regulatory
aspects
of
each
petition
and
coordinate
scientific
review
of
the
supporting
data.
Agency
residue
chemists
and
toxicologists
review
all
the
applicable
data.
As
a
result
of
these
reviews,
EPA
is
able
to
make
the
statutory
determination
that
the
resulting
pesticide
residues
in
food
or
feed
will
not
cause
unreasonable
adverse
dietary
effects
on
human
health.

3.
Non
Duplication,
Consultations,
and
Other
Collection
Criteria
3(
a).
Non
duplication
To
avoid
potential
overlap
between
the
requirement
of
developing
data
in
support
of
a
tolerance
petition
and
the
development
of
data
required
for
the
registration
of
a
pesticide
under
FIFRA,
EPA
allows
the
use
of
data
required
to
support
a
tolerance
petition
that
are
already
archived
in
EPA
records
for
use
as
part
of
a
FIFRA
registration
of
a
pesticide
to
be
used
in
a
like
manner
and
in
the
same
use
pattern.

3(
b).
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
published
a
Federal
Register
Notice
on
November
16,
2005
(
70
FR
69548)
(
Attachment
I)
and
provided
a
60­
day
public
notice
and
comment
period.
The
Agency
received
no
public
comments
regarding
the
potential
conditions
for
requiring
and
processing
submitted
information.
EPA
also
consulted,
their
comments
are
set
forth
below.

1
PR
Notice
97­
1
applies
to
most
applicants
with
registration
applications,
non­
crop­
destruct
experimental
use
permit
applications,
and
tolerance
or
tolerance
exemption
petitions
pending
within
the
Agency.
It
also
applies
to
most
future
applicants
seeking
new
or
amended
pesticide
registrations
and
all
actions
involving
synthetic
chemicals,
antimicrobial,
biochemical
and
microbial
pesticides.
3(
c).
Consultations
5
In
addition
to
the
public
notice
that
EPA
published
in
the
Federal
Register
concerning
the
renewal
of
this
ICR,
the
Agency
consulted,
as
required
under
5
CFR
1320.8(
d)(
1),
with
stakeholders
who
actively
interact
with
the
Agency
through
the
use
of
this
collection
instrument.
EPA
staff
contacted
three
relevant
stakeholders
and
asked
them
for
their
assessment
of
the
regulatory
burden
estimates
expressed
by
the
Agency
in
this
ICR.
EPA
consulted
with
the
following
individuals:

Daniel
Kunkel,
Ph.
D.
IR­
4
Program,
Rutgers
University
732­
932­
9575
Greg
Watson
Syngenta
Regulatory
Affairs
336­
632­
2993
Russell
Schneider
Monsanto
202­
383­
2866
Each
of
the
respondents
indicated
that
the
cost
estimates
were
comparable
to
current
costs.
One
respondent
indicated
that
the
inflationary
cost
increase
is
acceptable.
A
copy
of
the
questions
EPA
asked
as
part
of
the
consultations
are
listed
in
Attachment
G;
the
stakeholder
responses
are
included
in
Attachment
H.

3(
d).
Effects
of
Less
Frequent
Collection
Not
applicable.
This
activity
is
conducted
only
once
per
"
event,"
so
a
less
frequent
collection
is
not
possible.

3(
e).
General
Guidelines
Due
to
the
statutory
mandate
for
the
permanent
retention
of
supporting
chemistry
and
toxicological
data
related
to
pesticides,
the
data
included
in
petitions
must
be
maintained
for
the
life
of
the
pesticide.
This
mandate
exceeds
the
PRA
guideline
that
records
be
retained
for
no
more
than
three
years.

OMB=
s
regulations
require
agencies
to
provide
a
statement
indicating
whether
the
proposed
collection
of
information
involves
the
use
of
automated,
electronic,
mechanical,
or
other
technological
collection
techniques
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses,
and
an
explanation
of
the
decision
(
5
CFR
1320.5(
a)(
iii)(
E)).
Registrants
have
the
option
to
electronically
submit
underlying
study
data
required
by
the
Agency
in
support
of
the
tolerance
petition
process.
Under
this
option,
petitioners
need
only
submit
2
two
paper
copies
if
they
submit
the
required
study
data
in
Adobe
Acrobat
Portable
Document
Format
(
PDF)
on
a
compact
disc.
EPA
staff
have
become
familiar
with
the
electronic
submission
process
and
the
technology,
and
OPP
believes
this
option
is
allowing
the
Agency
to
achieve
operating
efficiencies
in
the
regulation
of
pesticides
through
the
promotion
and
facilitation
of
the
electronic
6
submission
process,
including
the
delivery,
review,
data
interchange
capability
and
archiving
of
data
supporting
the
petitions.
Under
this
option,
the
time
normally
required
for
OPP
to
complete
its
review
of
the
data
should
be
shortened,
thereby
allowing
faster
regulatory
decision­
making.

The
Agency
believes
that
petitioners
have
become
familiar
with
the
electronic
submission
process
and
the
technology,
and
they
are
able
to
prepare
their
data
submissions
in
less
time.
OPP
expects
that
petitioners
are
spending
less
time
and
money
preparing
copies
and
sending
their
submissions
using
the
hybrid
paper­
electronic
submission
option,
and
are
benefiting
from
the
efficiencies
that
EPA
expects
to
experience
during
data
reviews.

At
this
time
of
this
renewal,
OPP
is
not
offering
a
fully
electronic
submission
option.
OPP
is,
however,
beginning
the
process
of
defining
requirements
for
electronic
submission
of
studies
as
well
as
other
elements
of
applications
and
petitions.
This
includes
efforts
to
develop
information
technology
approaches
that
adequately
protect
FIFRA
Confidential
Business
Information
submitted
over
the
Internet.
In
the
interim,
please
see
EPA=
s
Electronic
Submission
Interim
Guidance
documents
(
Attachment
E).

3(
f).
Confidentiality
Trade
secret
or
confidential
business
information
(
CBI)
is
frequently
submitted
to
the
EPA
in
this
program
because
submissions
usually
include
the
manufacturing
process,
product
formulation,
and
supporting
data.
When
such
information
is
provided
to
the
Agency,
the
information
is
protected
from
disclosure
under
FIFRA
Section
10.
CBI
data
submitted
to
the
EPA
is
handled
strictly
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
Security
Manual.

3(
g).
Sensitive
Questions
Not
applicable.
No
information
of
a
sensitive
or
private
nature
is
requested
in
this
information
collection
activity.

4.
The
Respondents
and
the
Information
Requested
4(
a).
Respondents/
NAICS
Codes
Respondents
to
this
information
collection
activity
include
anyone
who
files
a
petition
asking
the
Agency
to
take
a
specific
tolerance
action.
Although
such
petitions
typically
come
from
those
businesses
engaged
in
the
manufacturing
of
pesticides,
the
Agency
may
also
receive
petitions
from
other
entities,
including
the
Interregional
Research
Project
No.
4
(
IR­
4),
third
party
registrants,
grower
groups,
importers
or
other
governments,
and
concerned
citizens.

Although
it
is
impossible
to
identify
all
the
North
American
Industrial
Classification
System
(
NAICS)
codes
for
all
of
the
potential
respondents,
the
NAICS
code
for
the
most
frequent
type
of
respondent
is:
7
Respondent
Category
NAICS
code
Examples
of
potentially
affected
entities
Pesticide
and
other
agricultural
chemical
manufacturing
325320
Individuals
or
entities
engaged
in
activities
related
to
the
registration
of
a
pesticide
product.

4(
b).
Information
Requested
(
i)
Data
Items,
Including
Record
Keeping
Requirements
In
addition
to
a
cover
letter
and
fee,
a
tolerance
petition
must
include
the
following
nine
parts:

Chemical
identity
The
name,
chemical
identity,
and
composition
of
the
pesticide
chemical.
If
the
pesticide
chemical
is
an
ingredient
of
a
pesticide,
the
complete
quantitative
formula
of
the
resulting
pesticide
product
should
be
submitted.
The
submission
of
this
information
does
not
restrict
the
application
of
any
tolerance
or
exemption
granted
to
the
specific
formula(
s)
submitted.

Chemical
use
The
amount,
frequency,
and
time
of
application
of
the
pesticide
chemical.

Safety
reports
Include
reports
of
investigations
made
with
respect
to
the
safety
of
the
pesticide
chemical.
These
reports
should
include,
when
necessary,
detailed
data
derived
from
appropriate
animal
or
other
biological
experiments
in
which
the
methods
used
and
the
results
obtained
are
clearly
set
forth.

Residue
test
results
The
results
of
tests
on
the
amount
of
residue
remaining,
including
description
of
the
analytical
method
used.
(
See
40
CFR
180.34
for
further
information
about
residue
tests.)

Residue
removal
Practicable
methods
for
removing
residue
that
exceeds
any
proposed
tolerance.
8
Proposed
tolerance
Proposed
tolerances
for
the
pesticidal
chemical
if
specific
tolerances
are
being
proposed.

Grounds
for
petition
Reasonable
grounds
in
support
of
the
petition.

Supplemental
information
Analysis
of
factors
relevant
to
the
provisions
of
FQPA
Summary
An
informative
summary
of
the
petition
or
application,
including
a
summary
of
the
supporting
data,
information,
accompanying
rationales,
and
a
statement
providing
permission
to
publish
such
summary.
This
summary
should
indicate
how
approval
of
the
petition
will
meet
the
statutory
determination
required
of
Areasonable
certainty
of
no
harm.@

There
are
no
forms
associated
with
this
information
collection.
The
data
compiled
should
be
submitted
as
separate
sections,
suitably
identified.
If
data
have
already
been
submitted
with
an
earlier
application,
the
petitioner
may
incorporate
it
by
reference
in
the
present
petition.
The
petition
must
be
submitted
in
triplicate.
The
petitioner
must
also
show
that
the
pesticide
is
already
registered
for
the
related
food
or
feed
use,
or
that
an
application
for
the
registration
of
a
pesticide
for
the
related
food
or
feed
use
has
been
submitted
pursuant
to
FIFRA
section
3
(
Attachment
C).

(
ii)
Respondent
Activities
In
order
for
a
tolerance
to
be
established
for
a
pesticide
product,
a
respondent
(
petitioner)
must
do
the
following:

Review
regulations
Read
applicable
FFDCA
provisions
and
related
tolerance
regulations;

Prepare
information
Prepare
supplemental
information
to
aid
Agency
decision­
making
concerning
a
tolerance
petition,
as
encouraged
by
the
Agency
and
outlined
in
Pesticide
Registration
Notice
97­
1
(
Attachment
D).

If
necessary,
this
may
involve:

 
conducting
additional
toxicological
or
residue
chemistry
studies
 
developing
analytical
methods
Prepare
correspondence
Generate
petition
correspondence,
including
preparing
an
informative
summary
to
be
published
in
the
Federal
Register;

Review
Agency
comment
If
applicable,
read
any
Agency
notice
of
petition
deficiency;

Respond
to
Agency
comment
Submit
supplemental
information
or
petition,
or
request
that
9
petition
be
filed
as
submitted;
and
Maintain
records
Store,
file
and
maintain
the
information
submitted.

5.
The
Information
Collected
­
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
Upon
receipt
of
a
tolerance
petition,
EPA
performs
the
following
activities:

Log
Receipt
Log
petition
and
associated
fee.

Review
petition
Screen
petition,
fee,
and
supporting
data
for
completeness
and
acceptability;
resolve
any
deficiencies
with
petitioner.

Prepare
Federal
Register
notice
Upon
acceptance,
publish
notice
of
filing
in
Federal
Register.

Review
data
Review
supporting
residue
chemistry,
toxicology
data
and
other
assessments
received.

Test
analytical
methods
Test
proposed
analytical
methods
in
EPA
laboratories,
if
they
are
new
or
modified.

Integrate
review
Integrate
data
reviews
and
determine
adequacy;
resolve
any
deficiencies
with
petitioner,
make
registration
decision.

Prepare
decision
document
Prepare
decision
document,
Federal
Register
Notice
with
rule
establishing
the
tolerance(
s)
or
exemption(
s).

Maintain
records
Record
all
actions
and
decisions
in
official
records.

5(
b).
Collection
Methodology
and
Management
Specific
studies
submitted
as
part
of
petition
are
catalogued
and
archived
as
they
are
received.
When
the
Agency
review
is
complete,
the
remaining
portions
of
the
petition
record,
including
correspondence
subsequent
to
filing
and
all
reviews,
notices,
and
other
materials
created
by
EPA
in
the
course
of
its
review,
are
catalogued
and
archived.
All
petition
materials
are
retained
permanently.

5(
c).
Small
Entity
Flexibility
At
times,
small
entities
seek
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
for
pesticide
residues
resulting
from
registered
uses.
These
actions
are
usually
initiated
for
minor
crop
uses
for
which
the
pesticide
registrant
is
unwilling
to
seek
a
tolerance
or
for
residues
on
commodities
which
are
not
grown
in
the
United
States
and
therefore
for
which
there
10
is
no
U.
S.
registrant,
such
as
import
tolerances.
In
such
cases,
the
EPA
can
reduce
the
burden
and
cost
to
small
entities
by
adjusting
the
range
of
data
requirements
to
be
commensurate
with
the
extent
of
pesticide
use.
The
Agency
also
uses
this
type
of
regulatory
flexibility
to
set
tolerances
for
residues
on
commodities
which
are
not
grown
in
the
United
States.

5(
d).
Collection
Schedule
Not
applicable.
This
is
not
a
scheduled
collection.
A
petition
is
required
only
once
for
each
raw
or
processed
commodity
on
which
the
pesticide
is
used.

6.
Estimating
the
Burden
and
Cost
of
the
Collection
6(
a).
Estimating
Respondent
Burden
The
respondent
burden
reflected
in
this
ICR
is
for
petition
requests
for
new
tolerance
actions.
This
ICR
does
not
reflect
burden
associated
with
the
Agency=
s
pesticide
tolerance
reassessment
program.
The
bulk
of
tolerance
reassessment
activities
are
conducted
through
the
reregistration
program.
As
a
result,
the
respondent
burden
associated
with
the
FQPA
standards
for
tolerance
reassessment
activities
have
been
estimated
as
part
of
the
Data
Generation
for
Pesticide
Reregistration
ICR
(
OMB
No.
2070­
0107;
EPA
ICR
No.
1504)
for
active
ingredients,
and
are
not
included
in
this
ICR.

Since
1995,
the
Agency
has
allowed
for
the
use
of
a
single
petition
to
request
a
tolerance
action(
s)
for
a
group
of
similar
crops,
or
"
Crop
Groupings,"
rather
than
submitting
individual
petitions
on
a
crop
by
crop
basis.
In
reviewing
some
of
the
petitions,
it
is
apparent
that
many
petitioners
take
advantage
of
this
flexibility,
including
in
the
petition
requests
for
several
tolerance
actions.
Some
have
sought
as
many
as
15
crops
per
petition,
including
crop
groupings.
FQPA
amendments
allow
anyone
to
submit
a
petition,
where
previously
only
registrants
could
submit
the
petition.

Section
408
of
FFDCA
requires
petitioners
submit
Aan
information
summary
of
the
petition
and
of
the
data,
information
and
arguments
submitted
or
cited
in
support
of
the
petition.@
FQPA
requires
EPA
to
consider
additional
information
in
order
to
make
the
necessary
regulatory
decisions.
EPA
encouraged
petitioners
who
previously
submitted
data
prior
to
enactment
of
the
law
to
supplement
their
original
submissions
with
additional
information
to
aid
the
Agency=
s
decision­
making
process
in
light
of
its
new
statutory
mandates.
To
allow
for
the
most
efficient
processing
and
review
of
tolerance
petitions,
the
Agency
provided
a
description
of
the
types
of
information
that
EPA
considers
helpful
in
the
appendices
to
Pesticide
Registration
(
PR)
Notice
No.
97­
1
(
Attachment
D).

EPA
continues
to
encourage
petitioners
to
develop
new
and/
or
submit
any
existing
supplemental
information
with
their
petitions
to
help
EPA
determine
whether
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure.
EPA
uses
the
data
to
make
decisions
about
the
tolerance
petitions.
The
Agency=
s
risk
managers
review,
among
other
things,
the
regulatory
aspects
of
each
petition
and
coordinate
scientific
review
of
the
supporting
data.
11
Agency
residue
chemists
and
toxicologists
review
all
the
applicable
data.

Two
types
of
burden
on
respondents
are
considered
in
this
analysis:
administrative
burden
and
technical
burden.
The
respondents=
administrative
burden
is
defined
as
the
time
spent
to
prepare
and
submit
a
petition
to
the
Agency.
This
burden
includes
the
time
spent
working
with
the
Agency
throughout
the
petition
process,
gathering
data
and
supplemental
information
(
such
as
the
safety
reports,
residue
test
data,
residue
removal
data),
drafting
the
grounds
for
the
petition,
reviewing
and
submitting
the
petition.
The
technical
burden
includes
the
labor
needed
to
actually
derive
the
test
data
which
involves
designing
the
test,
performing
it,
compiling
test
data
and
summarizing
the
results.
For
the
purposes
of
calculating
paperwork
burden,
only
the
technical
burden
related
to
the
documentation
of
the
test
results,
complying
with
good
laboratory
standards
in
conducting
the
tests,
and
storing
testing
information
in
files
are
included
in
the
burden
estimates
for
this
ICR.

To
quantify
the
administrative
burden,
the
Agency
estimated
the
amount
of
labor
as
a
percentage
of
the
total
test
costs.
The
Agency
assumed
that
respondents
would
expend
approximately
two
percent
of
the
total
test
cost
for
administrative
paperwork
burden.
This
percentage
represents
an
estimate
obtained
from
expert
opinion,
industry
sources,
and
proprietary
data.
The
Agency
assumed
that
the
value
of
this
time
is
equally
divided
among
management
and
technical
staff
members.

The
methodology
for
calculating
the
technical
burden
differs
from
the
administrative
burden.
One­
third
of
the
total
test
cost
represents
labor.
Management,
technical
and
clerical
comprises
the
labor
staff.
A
proportional
labor
rate
is
used
to
calculate
the
number
of
hours.
Approximately
70
percent
is
technical,
20
percent
management,
and
10
percent
clerical.

As
in
previous
renewal
of
this
information
collection
request,
this
current
renewal
estimates
that
an
average
of
150
tolerance
petitions
will
be
submitted
to
the
Agency
each
year
for
the
next
three
years.
The
estimate
has
not
changed
from
the
previous
ICR.
As
in
the
previous
renewal,
the
Agency
estimates
that
the
average
paperwork
burden
associated
with
the
submission
of
a
single
tolerance
petition
is
1,726
hours.
Assuming
that
the
Agency
will
receive
an
average
150
tolerance
petitions
each
year
for
the
next
3
years,
the
Agency
estimates
that
the
overall
annual
paperwork
burden
will
be
258,900
hours.
12
Table
1
B
ANNUAL
RESPONDENT
BURDEN/
COST
ESTIMATES
BURDEN
HOURS
(
per
petition)
COSTS
(
per
petition)
ACTIVITIES
Mgmt.
$
133/
hr
Tech.
$
90/
hr
Cler.
$
41/
hr
Total
Hours
Total
Costs
a)
Review
FFDCA
regulations
CFR
citation;
PRN
97­
1
25
48
24
97
$
8,629
b)
Conduct
Field
Trial
252
1,080
25
1,357
$
131,741
c)
Prepare
Petition
42
30
116
188
$
13,042
d)
Read
Notice
of
any
petition
deficiency
1
1
1
3
$
264
e)
Prepare
response
2
44
12
58
$
4,718
f)
Maintain
information
1
8
14
23
$
1,427
TOTAL
BURDEN
323
1,211
192
1,726
$
159,821
ANNUAL
BURDEN:
1,726
total
hours
x
150
petitions
=
258,900
hours
6(
b).
Estimating
Respondent
Costs
The
overall
annual
cost
associated
with
this
information
collection,
based
on
an
estimate
of
150
petitions
per
year,
is
estimated
to
be
$
23,973,150.
For
respondents,
the
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
133,
$
90,
and
$
41,
respectively.
As
part
of
this
ICR
renewal,
EPA
increased
its
previously
estimated
labor
rates
for
respondents
by
using
the
NASA
Gross
Domestic
Product
Inflation
Calculator.
This
is
an
inflation
calculator
for
adjusting
costs
from
one
year
to
another
using
the
Gross
Domestic
Product
(
GDP)
Deflator
inflation
index.
This
inflation
calculator
is
based
on
the
inflation
rate
during
the
US
Government
Fiscal
Year,
which
begins
on
October
1
and
ends
on
September
30.
This
inflation
calculator
will
compute
inflation
from
1940
to
2009.

These
labor
rates
are
fully
loaded
and
include
benefits
and
overhead
costs.
Using
the
Agency=
s
burden
estimate
and
the
fully­
loaded
labor
rates,
the
Agency
estimates
the
applicant
costs
to
be
approximately
$
159,821
per
response.

ANNUAL
COSTS:
(
a)
Management
­
323
hours
x
$
133
x
150
applicants
$
6,443,850
(
b)
Technical
­
1211
hours
x
$
90
x
150
applicants
$
16,348,500
(
c)
Clerical
­
192
hours
x
$
41
x
150
applicants
$
1,180,800
TOTAL
$
23,973,150
These
labor
burden
estimates
represent
the
average
time
and
costs.
Some
tolerance
petitions
will
require
less
effort
and
more
complicated
petitions
will
require
more
of
each.
The
13
analysis
assumes
that
one
respondent
will
generate
the
data
for
a
given
petition.
If
a
consortium
takes
responsibility
for
the
petition,
the
burden
and
cost
will
be
distributed
across
members
of
the
consortium.

6(
c).
Estimating
Agency
Burden
and
Cost
The
Agency
needs
to
process,
review
and
document
their
evaluation
of
the
tolerance
petitions.
Each
year,
the
Agency
may
spend
2300
hours
for
150
petitions
in
labor
burden.
EPA
increased
its
previously
estimated
labor
rates
for
respondents
by
using
the
NASA
Gross
Domestic
Product
Inflation
Calculator.
This
is
an
inflation
calculator
for
adjusting
costs
from
one
year
to
another
using
the
Gross
Domestic
Product
(
GDP)
Deflator
inflation
index.
This
inflation
calculator
is
based
on
the
inflation
rate
during
the
US
Government
Fiscal
Year,
which
begins
on
October
1
and
ends
on
September
30.
This
inflation
calculator
will
compute
inflation
from
1940
to
2009.
Estimates
for
the
Agency's
burden
are
provided
below.

Table
2
B
ANNUAL
AGENCY
BURDEN/
COST
ESTIMATES
BURDEN
HOURS
(
per
year)
COSTS
(
per
year)
COLLECTION
ACTIVITIES
Mgmt.
$
101/
hr
Tech.
$
74/
hr
Cler.
$
35/
hr
Total
Hours
Total
Costs
a)
Log
petition
and
associated
fee
0
8
0
8
$
592
b)
Screen
petition
request
for
completeness
1
2
0
3
$
249
c)
Draft
and
publish
Federal
Register
notice
1
4
0
5
$
397
d)
Review
Residue
Chemistry
and
Toxicology
data
200
1,642
3
1845
$
141,813
e)
Verify
new
analytical
methods
in
EPA
Lab.
and
resolve
any
deficiencies
34
223
1
258
$
19,971
f)
Integrate
Data
Reviews
67
100
2
169
$
14,237
g)
Prepare
decision
document
and
Federal
Register
Notice
4
4
2
10
$
770
h)
Record
actions
in
official
records.
0
0
2
2
$
70
TOTAL
BURDEN
307
1983
10
2300
$
170,099
(
a)
Management
­
307
hours
x
$
101
x
150
petitioners
$
4,651,050
(
b)
Technical
­
1,983
hours
x
$
74
x
150
petitioners
$
22,011,300
(
c)
Clerical
­
10
hours
x
$
35
x
150
petitioners
$
52,500
TOTAL
$
26,714,850
14
6(
d).
Bottom
Line
Burden
Hours
And
Cost
Tables
Table
3
B
MASTER
TABLE:
Total
Annual
Burden
Hours
and
Costs
Annual
Burden
Hours
Annual
Costs
Total
Annual
petitions
per
petition
Total
per
petition
Total
Respondents
(
Petitioners)
150
1726
258,900
$
159,821
$
23,973,150
Agency
150
2300
345,000
$
170,099
$
26,714,850
6(
e).
Reasons
for
Change
in
Burden
Respondent
costs
for
this
ICR
have
increased
due
to
inflationary
adjustments
in
labor
rates
for
both
respondents
and
Agency
personnel.
As
a
result,
there
is
an
increase
of
$
537,450
in
the
estimated
total
annual
respondent
cost
(
from
$
23,435,700
to
$
23,973,150).

6(
f).
Burden
Statement
The
total
estimated
annual
respondent
paperwork
burden
to
comply
with
this
information
collection
activity
is
258,900
hours.
According
to
the
Paperwork
Reduction
Act,
Aburden@
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
appears
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
(
Attachment
F).

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.
EPA­
HQ­
OPP­
2005­
0291,
which
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1801
S.
Bell
St.,
Arlington,
VA.
The
Docket
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Docket
is
(
703)
305­
5805.
An
electronic
version
of
the
public
docket
is
available
through
Federal
eRulemaking
Portal,
http://
www.
regulations.
gov.
Follow
the
online
instructions
for
viewing
documents
and
submitting
comments.
You
can
also
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
docket
ID
No.
EPA­
HQ­
OPP­
2005­
0291
and
OMB
control
number
2070­
0024
in
any
correspondence.
Attachments
List
All
of
the
attachments
listed
below
can
be
found
in
the
docket
for
this
ICR
(
unless
otherwise
noted);
accessible
electronically
through
www.
Regulations.
gov
.
On
the
main
page,
select
Advanced
Search
from
the
menu
bar
at
the
top
and
select
Docket
Search.
Enter
the
Docket
ID
Number,
EPA­
HQ­
OPP­
2005­
0291
in
the
Docket
ID
field.
Click
on
the
Submit
button.
From
the
results
page,
you
will
be
able
to
link
to
the
docket
view
or
directly
open
select
documents
found
in
the
docket.

ATTACHMENT
A:
FFDCA
Sections
402,
406,
408,
and
409
(
21
U.
S.
C.
Sections
342,
346,
346a,
and
348,
respectively).

ATTACHMENT
B:
40
CFR
Parts
180.7
through
180.41
­
Tolerances
and
Exemptions
from
Tolerances
for
Pesticide
Chemicals
in
or
on
Raw
Agricultural
Commodities.

ATTACHMENT
C:
FIFRA
Section
3
(
7
U.
S.
C.
136a).

ATTACHMENT
D:
PR
Notice
97­
1
­
Agency
Actions
under
the
Requirements
of
the
Food
Quality
Protection
Act.

ATTACHMENT
E:
Electronic
Submission
Interim
Guidance
Documents
­
available
electronically
at
http://
www.
epa.
gov/
oppfead1/
eds/
esr_
guidance.
htm.

ATTACHMENT
F:
Display
Related
to
OMB
Control
#
2070­
0024
­
Listings
of
Related
Regulations
in
40
CFR
9.1.

ATTACHMENT
G:
List
of
Consultation
Questions
ATTACHMENT
H:
Response
to
EPA
on
ICR
Burden
Consultation
(
Record
of
Consultation
Correspondence)

ATTACHMENT
I:
First
Federal
Register
Notice
­
70
FR
69548
­
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients;
Renewal
of
Pesticide
Information
Collection
Activities
and
Request
for
Comments
(
published
November
16,
2005).
