Document ID: EPA-HQ-OPP-2002-0321-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-11-06T05:00Z

November
20,
2002
Page
1
of
26
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection
Notice
of
Pesticide
Registration
by
States
to
Meet
a
Special
Local
Need
(
SLN)
under
FIFRA
Section
24(
c)

OMB
NO.
2070­
0055;
EPA
NO.
0595.08
1(
b)
Short
Characterization/
Abstract
This
data
collection
program
is
designed
to
provide
the
Environmental
Protection
Agency
(
EPA,
the
Agency)
with
the
necessary
data
to
review
approval
of
State­
issued
pesticide
registrations.
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
Section
24(
c)
authorizes
the
States
to
register
additional
uses
of
federally
registered
pesticides
for
distribution
and
use
within
the
State
to
meet
a
special
local
need
(
SLN).
A
State­
issued
registration
under
FIFRA
section
24(
c)
is
deemed
a
federal
registration
for
the
purposes
of
the
pesticide's
use
within
the
State's
boundaries.
A
State
must
notify
EPA,
in
writing,
of
any
action
it
takes,
i.
e.,
when
it
issues,
amends,
or
revokes
a
State
registration.
The
Agency
has
90
days
to
disapprove
the
registration.
In
such
cases,
the
State
is
responsible
for
notifying
the
affected
registrant.

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
The
EPA
requires
this
information
to
ensure
that
the
States
do
not
issue
any
registrations
that
might
conflict
with
other
requirements
in
FIFRA,
or
with
section
408
of
the
Federal
Food
Drug,
and
Cosmetic
Act
(
FFDCA)
which
require
that
a
tolerance
exist
for
any
pesticide
used
on
a
food
or
feed
commodity.
FIFRA
section
24
(
c)(
3)
mandates
that
if
the
Administrator
determines
that
a
registration
issued
by
a
State
is
inconsistent
with
the
FFDCA
or
if
the
use
of
a
pesticide
registered
by
the
State
constitutes
an
imminent
hazard,
the
Administrator
may
disapprove
the
registration.

2(
b)
Practical
Utility/
Users
of
the
Data
The
potential
respondents
to
this
information
collection
activity
are
the
States,
which
are
defined
in
FIFRA
section
2
(
aa)
to
include
Washington,
D.
C.,
Puerto
Rico,
the
U.
S.
Virgin
Islands,
Guam
and
the
islands
of
the
Pacific
Territory,
and
American
Samoa.
The
information
"
users"
are
the
Agency
decision
makers
within
the
Office
of
Pesticide
Programs
(
OPP)
and
is
used
November
20,
2002
Page
2
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26
to
ensure
conformity
with
FIFRA
and
FFDCA.
The
States
are
required
to
collect
from
the
manufacturer
or
grower
groups
adequate
information
to
support
the
section
24(
c)
application
for
registration
or
amendment.
Both
the
State
and
the
manufacturer
or
grower
group
are
required
to
keep
records.

3.
NON
DUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non
duplication
Not
applicable.
This
is
the
only
information
collection
activity
of
its
kind
and
information
collected
in
this
data
collection
program
is
collected
only
once
per
receipt
of
an
application
for
a
FIFRA
section
24(
c)
registration.
Consequently,
the
possibility
for
duplication
does
not
exist.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
published
a
Federal
Register
(
FR)
Notice
that
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
February
11,
2002
(
see
Attachment
C).
The
Agency
received
one
comment
(
Attachment
D)
in
response
to
this
notice
from
Mr.
Erik
Johansen
of
the
Washington
State
Department
of
Agriculture
(
WSDA).
Mr.
Johansen
noted
that
the
estimated
total/
average
number
of
responses
from
each
respondent,
which
was
listed
in
the
FR
Notice
as
1­
3,
appeared
to
be
low.
Mr.
Johansen
estimated
that
the
WSDA
issues
approximately
37
SLN
registrations
per
year
and
corresponds
with
EPA
a
total
of
approximately
75­
100
times
per
year
regarding
SLN
registrations.
This
correspondence
includes
label
revisions,
cancellations
of
SLN
registrations,
and
other
actions.

EPA
carefully
considered
Mr.
Johansen's
comments
and
agrees
with
his
assertion
that
its
estimate
of
the
total/
average
number
of
responses
from
each
respondent
which
was
listed
in
the
first
FRN
as
1­
3
was
low.
This
renewal
ICR
includes
a
more
realistic
estimate
of
5­
6
responses
per
State
(
the
Agency
expects
to
receive
an
average
of
350
applications
annually
for
the
three
years
covered
by
this
renewal
ICR,
divided
by
60
respondents).
In
addition,
Mr.
Johansen
commented
that
the
estimated
number
of
responses
from
each
respondent
pertaining
to
activities
such
as
those
described
in
his
comment
should
be
included
in
the
activity
description
and
accounted
for
as
paperwork
burdens.
The
burden
estimates
in
this
ICR
for
State
governments
already
include
the
preceding
activities
as
part
of
the
paperwork
burden,
but
the
Agency
has
updated
the
activity
descriptions
in
this
ICR
to
more
accurately
reflect
Mr.
Johansen's
concerns.

3(
c)
Consultations
In
addition
to
informal
consultation
between
States
and
the
EPA
during
the
submission
and
review
of
SLN
registration
applications,
which
occurs
on
an
ongoing
basis,
EPA
staff
contacted
the
following
representatives
of
State
regulatory
agencies
and
asked
them
for
their
November
20,
2002
Page
3
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26
assessment
of
the
burden
estimates
in
the
ICR:

John
Inouye
California
Department
of
Pesticide
Regulation
Sacramento,
CA
Phone:
(
926)
324­
3538
John
R.
Lake
Pennsylvania
Department
of
Agriculture
Harrisburg,
PA
17110
Phone:
(
717)
772­
5211
Mr.
Jim
Gray
North
Dakota
Department
of
Agriculture
Bismarck,
ND
58505
Phone:
(
701)
382­
1505
Mr.
Inouye
replied
that
conditions
pertaining
to
SLN
registrations
vary
so
widely
in
his
State
that
providing
an
estimate
was
not
possible.
Mr.
Lake
responded
that
he
estimated
that
processing
of
an
SLN
registration
by
his
State,
depending
on
concerns
applicable
to
the
pesticide
and
use
requested,
could
range
from
as
many
as
24
hours
to
as
few
as
3.
Mr.
Gray's
response
also
indicated
that
processing
time
could
vary
widely
depending
on
various
concerns,
but
that
processing
time
averaged
approximately
15
hours
per
submission.
The
Agency
agrees
with
these
assessments,
and
based
on
the
responses
received,
calculates
that
the
States
spend
an
average
of
13
hours
processing
an
SLN
submission.

EPA
staff
also
contacted,
by
electronic
mail,
representatives
of
companies
involved
as
applicants
for
State
registrations
to
obtain
their
assessment
of
the
burden
associated
with
this
information
collection
activity.
The
Agency
received
feedback
from
the
following
pesticide
registrants
and
included
their
responses
as
Attachment
E
to
this
supporting
statement:

Rebecca
Johnston
BASF
Corp.
Mt.
Olive,
NJ
Jack
Cain
Dupont
Wilmington,
DE
F.
Andy
Hedgecock
Monsanto
Co.
St.
Louis,
MO
November
20,
2002
Page
4
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26
Greg
Watson
Syngenta
Greensboro,
NC
The
Agency
used
the
registrant
feedback
to
revise
the
estimated
burden
for
submitting
applications
for
special
local
need
registrations
to
States
and
has
provided
a
detailed
discussion
in
section
6
of
this
supporting
statement.

3(
d)
Effects
of
Less
Frequent
Collection
Not
applicable.
This
activity
is
conducted
only
once
per
receipt
of
an
application
for
a
FIFRA
section
24(
c)
registration.
Consequently,
there
is
no
way
that
the
EPA
can
reduce
the
frequency
of
the
collection.

3(
e)
General
Guidelines
The
recordkeeping
activities
briefly
described
in
this
ICR
exceed
OMB's
guideline
that
agencies
not
require
that
records
be
retained
for
more
than
3
years
(
5
CFR
1320.5(
d)(
2)(
iv)).
As
authorized
under
FIFRA
section
8,
EPA
regulations
require
that
registrants
retain
records
containing
research
data
relating
to
registered
pesticides
(
including
all
data
submitted
to
EPA
in
support
of
a
registration
­
see
40
CFR
169.2(
k))
for
as
long
as
the
registration
is
valid
and
the
producer
is
in
business.
However,
the
burden
related
to
the
recordkeeping
requirements
is
covered
under
another
ICR
(
see
OMB
Control
No.
2070­
0028,
Recordkeeping
Requirements
for
Producers
of
Pesticides
under
Section
8
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)).

In
addition,
this
ICR
does
not
include
any
estimated
burden
or
costs
related
to
the
third
party
activities
associated
with
pesticide
product
labeling.
In
1995,
OMB
determined,
in
the
context
of
OMB
Control
No.
2070­
0060,
Application
for
New
and
Amended
Pesticide
Registration,
that
the
Agency
does
not
need
to
estimate
burden
or
costs
for
the
third
party
disclosure
requirement
involving
the
registrant's
disclosure
of
product
specific
information
to
potential
users
and
the
general
public
through
the
pesticide
labeling.
This
activity
is
not
considered
to
be
a
collection
of
information
subject
to
approval
under
the
PRA
because
the
information
that
must
be
included
as
the
product
labeling
has
been
approved
and
provided
by
EPA.
(
5
CFR
1320.3(
c)(
2)).

Finally,
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)).
At
the
present
time,
applications
for
24(
c)
registration
are
submitted
on
written
forms
via
the
mail.
OPP
is
not
yet
prepared
to
accept
the
electronic
submission
of
any
forms
listed
in
this
ICR.
Forms­
based
submissions
likely
would
be
transmitted
via
the
World
Wide
Web
and
neither
OPP
nor
the
Agency's
Office
of
Environmental
Information
have
developed
the
information
technology
November
20,
2002
Page
5
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26
approaches
that
would
adequately
protect
FIFRA
Confidential
Business
Information
submitted
in
this
way.

3(
f).
Confidentiality
The
Agency
estimates
that
fewer
than
0.1%
of
the
24(
c)
registrations
it
receives
are
for
new
products
and
would
thus
require
submission
of
a
Confidential
Statement
of
Formula,
which
contains
Confidential
Business
Information
(
CBI).
However,
as
many
as
5%
to
10%
of
24(
c)
registrations
may
include
residue
data,
which
also
contains
CBI,
in
support
of
an
unregistered
use.
In
addition,
any
data
and/
or
information
brought
to
the
Agency
in
conjunction
the
submission
of
24(
c)
registrations
may
be
claimed
as
trade
secret,
commercial
or
financial
information
and
must
be
protected
from
disclosure
by
EPA
under
FIFRA
section
10
and
the
associated
regulation
as
contained
in
40
CFR
Part
2,
Subpart
B.
All
CBI
data
submitted
to
the
EPA
under
FIFRA
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
conjunction
with
this
collection
activity.
In
addition,
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
Code
Section
2(
aa)
of
FIFRA
defines
"
State"
to
include
any
of
the
50
States,
the
District
of
Columbia,
the
Commonwealth
of
Puerto
Rico,
the
United
States
Virgin
Islands,
Guam,
the
Trust
Territory
of
the
Pacific
Islands,
and
American
Samoa.
The
North
American
Industrial
Classification
System
(
NAICS)
code
for
the
State
government
agencies
participating
in
this
data
collection
is
92411.

4(
b)
Information
Requested
(
i)
Information
Requested
by
States
to
support
SLN
registrations.

(
A)
Application
for
a
24(
c)
registration.

Applicants
for
State
registrations
under
FIFRA
section
24(
c)
to
meet
a
special
local
need
(
typically
pesticides
manufacturers
and
grower
groups)
must
submit
the
following
information
directly
the
State
using
EPA
Form
8570­
25,
Application
for/
Notification
of
State
Registration
of
November
20,
2002
Page
6
of
26
a
Pesticide
to
Meet
a
Special
Local
Need
(
Attachment
F)
and
EPA
Form
8570­
4,
Confidential
Statement
of
Formula,
(
Attachment
G)
when
applicable:

(
1)
Name
and
address
of
the
applicant
and
any
other
person
whose
name
will
appear
on
the
labeling
or
in
the
directions
for
use.

(
2)
The
name
of
the
pesticide
product,
and,
if
the
application
is
for
an
amendment
to
a
federally
registered
product
the
EPA
registration
number
of
that
product,

(
3)
A
copy
of
the
proposed
labeling,
including
all
claims
made
for
the
product
as
well
as
directions
for
its
use
to
meet
the
special
local
need,
consisting
of:
(
a)
For
a
new
product,
a
copy
of
the
complete
proposed
labeling;
or,
(
b)
For
an
additional
use
of
a
federally
registered
product,
a
copy
of
proposed
supplemental
labeling
and
a
copy
of
the
labeling
for
the
federally
registered
product.
(
c)
If
a
State
classifies
for
restricted
use
a
product
or
use,
which
is
not
required
to
be
so
classified
under
FIFRA,
supplemental
labeling
for
the
product
or
use
containing
additional
appropriate
precautions,
and
a
statement
that
the
product
or
use
is
for
restricted
use
within
the
State
may
be
required.

(
4)
The
complete
formula
of
the
product,
if
the
application
is
for
a
new
product
registration.

(
5)
Any
other
information
that
is
required
to
be
reviewed
prior
to
registration.

(
B)
Information
following
the
issuance
of
a
24(
c)
registration.

A
copy
of
the
final
printed
labeling
as
soon
as
practical
after
a
registration
is
issued.
New
product
labeling
must
all
contain:

(
1)
A
statement
identifying
the
State
where
registration
is
to
be
valid.
(
2)
The
special
local
need
registration
number
assigned
by
the
State.
(
3)
For
an
additional
use
of
a
federally
registered
product,
the
State
must
require
that
at
the
time
of
sale,
labeling
from
the
federally
registered
product
be
accompanied
by
supplemental
labeling.

(
C)
Information
Requested
by
EPA
to
verify
an
SLN
registration.

Within
ten
working
days
from
the
date
a
State
issues,
amends
or
revokes
a
registration,
the
State
is
required
to
notify
the
EPA,
in
writing,
of
the
action.

(
1)
Using
EPA
Form
8570­
25
where
applicable,
notification
of
State
registrations,
or
amendments
thereto,
shall
include:
November
20,
2002
Page
7
of
26
(
a)
Effective
date
of
the
registration
or
amendment,
(
b)
Confidential
statement
of
the
formula
of
any
new
product,
and
(
c)
A
copy
of
the
draft
labeling
reviewed
and
approved
by
the
State,
provided
that
labeling
previously
approved
by
the
Administrator
as
part
of
a
federal
registration
need
not
be
submitted.

(
2)
Notification
of
State
registrations
or
amendments
shall
be
supplemented
by
the
State
sending
to
the
EPA
a
copy
of
the
final
printed
labeling
approved
by
the
State
within
60
days
after
the
effective
date
of
the
registration
or
amendment.

(
3)
Notification
of
revocation
of
a
registration
by
a
State
shall
indicate
the
effective
date
of
revocation,
and
shall
state
the
reasons
for
revocation.

(
4)
The
Agency
may
request,
when
appropriate,
that
a
State
submit
any
data
used
by
the
State
to
determine
that
unreasonable
adverse
effects
will
not
be
caused.

(
ii)
Respondent
Activities
The
following
are
the
activities
in
which
an
applicant
must
engage
in
order
to
obtain
a
State
registration
under
FIFRA
section
24(
c).

Gather
data
Proposed
label,
product
formulation
(
if
applicable),
name
of
applicant,
name
of
product,
federal
registration
number
(
if
applicable),
and
any
other
information
required
by
the
State.

Submit
materials
to
the
State
Compile
necessary
data
and
materials.
Complete
application
for
State
registration
(
EPA
Form
8570­
25)
and
submit
to
State
Store,
file,
and
maintain
the
information
Applicant
must
maintain
records
of
information
submitted
to
the
State
for
as
long
as
the
State
registration
is
active.
November
20,
2002
Page
8
of
26
A
State
must
engage
in
the
following
activities
in
order
to
comply
under
this
data
collection
program:

Compile
information
Organize
data
submitted
by
registrant
(
or
grower
group)
to
develop
the
SLN
justification.
Registrant
must
maintain
records
of
information
submitted
to
the
State.

Review
information
Evaluate
the
data:
1.
Determine
whether
there
is
a
special
local
need
for
the
registration;
2.
Determine
that
use
of
the
product
for
which
registration
is
sought
will
not
cause
unreasonable
adverse
effects
on
humans
or
the
environment;
3.
For
use
of
a
product
with
public
health
claims,
determine
that
the
product
warrants
the
claims
made,
i.
e.,
efficacy
determination;
4.
Review
the
proposed
labeling
submitted
with
the
application
to
determine
State
and
federal
compliance;
5.
Issue
or
amend
State
registration.

Notify
Federal
Government
Complete
and
submit
EPA
Form
8570­
25
and
all
accompanying
data
and
materials.
Respond
to
any
Agency
questions
or
concerns.

Store,
file,
and
maintain
the
data
Maintain
copies
of
the
information
and
data
submitted
to
EPA.

Respond
to
Registrant
(
if
necessary)
Notify
registrant
if
Federal
Government
disapproves
the
State's
registration.
November
20,
2002
Page
9
of
26
5.
THE
INFORMATION
COLLECTED
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
EPA
must
conduct
the
following
activities
under
this
data
collection
activity:

Read
and
record
State­
submitted
information
EPA
Form
8570­
25
and
the
application
is
screened,
jacket
created,
and
information
is
recorded
in
electronically
for
tracking
purposes.

Review
data
submissions
Review
materials
for
adherence
to
federal
requirements
of
label
integrity,
lack
of
imminent
risk,
and
the
existence
of
appropriate
tolerances.

Publish
summary
of
24(
c)
s
Publish,
on
a
regular
basis,
in
the
Federal
Register,
a
summary
of
all
State
registrations
received
and
those
disapproved.

Notify
State
(
if
necessary)
Notify
the
State
if
the
registration
is
disapproved.

Store/
file/
maintain
the
data
Maintains
an
electronic
reference
file
on
all
FIFRA
section
24(
c)
applications
received
and
approved.

5(
b)
Collection
Methodology
and
Management
The
section
24(
c)
application
form
and
any
supporting
materials
are
received
and
datemarked
to
start
the
90­
day
clock.
They
are
screened
for
completeness,
a
master
file
jacket
is
created
for
the
incoming
application,
and
the
case
is
assigned
a
unique
identifier.
Identifying
information
then
is
extracted
for
the
required
FR
Notice
of
receipt,
for
the
Pesticide
Product
Information
System
(
PPIS)
inventory
of
all
24(
c)
actions,
and
for
tracking
records.

The
file
then
is
reviewed
for
substantive
acceptability,
and
any
scientific
data
is
routed
for
review
by
appropriate
specialists.
When
all
reviews
are
completed
a
decision
is
made
to
accept
or
disapprove
the
application.

If
the
decision
is
to
disapprove
the
application,
the
State
is
notified,
and
a
notice
of
disapproval
is
published
in
the
FR.
The
disapproval
is
recorded
in
the
PPIS
data
base.
If
the
decision
is
to
accept
the
application,
this
is
recorded
in
the
master
file,
and
no
further
action
is
required.
November
20,
2002
Page
10
of
26
5(
c)
Small
Entity
Flexibility
Not
applicable.
As
identified
in
section
4(
a)
of
this
supporting
statement,
Section
24
of
FIFRA
applies
directly
only
to
the
government
agencies
of
the
50
states,
Washington
D.
C.,
and
the
territorial
governments
of
the
United
States;
it
does
not
apply
to
other
entities.
States
are
not
small
entities
as
defined
under
the
Regulatory
Flexibility
Act
and
the
Unfunded
Mandates
Reform
Act.
Small
entity
flexibility
does
not
exist
under
this
information
collection
activity
because
the
respondent
community
does
not
consist
of
any
small
entities.
While
pesticide
manufacturers
and
grower
groups
may
be
affected
by
EPA­
State
activities
under
this
ICR,
any
activities
they
undertake
are
in
response
to
FIFRA
Section
24,
which
expressly
delegates
certain
pesticide
registration
authority
to
States.
These
entities
must
comply
with
State
procedures
to
obtain
a
special
local
need
registration
under
FIFRA
section
24(
c).
Consequently,
the
Agency
cannot
offer
them
any
flexibility
without
intruding
on
State
processes.

5(
d)
Collection
Schedule
Not
applicable.
This
activity
is
conducted
only
once
per
receipt
of
an
application
for
a
FIFRA
section
24(
c)
registration.
Consequently,
there
is
no
set
schedule
for
collection
of
this
information.

6.
ESTIMATING
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a)
Estimating
Respondent
Burden
(
i)
Applicant
Burden
As
discussed
in
further
detail
under
section
6(
e)
of
this
supporting
statement,
the
Agency
estimates
the
average
burden
for
applicants
for
State
registrations
under
FIFRA
section
24(
c)
to
equal
approximately
39
hours
per
response.
This
includes
14
hours
of
management
labor,
19
hours
of
technical
labor
and
6
hours
of
clerical
labor
per
response.
The
Agency
expects
that
nearly
350
applications
will
be
submitted
annually
during
the
next
3
years
and
therefore
estimates
that
the
annual
applicant
burden
will
equal
13,650
hours.

(
ii)
State
Agency
Burden
As
discussed
in
further
detail
in
sections
3(
c)
and
6(
e)
of
this
supporting
statement,
EPA
estimates
the
State
Agency
burden
to
average
13
hours
per
response.
This
includes
an
estimated
12.3
hours
of
technical
labor
and
0.7
hours
of
clerical
labor
per
State
agency
response.
The
Agency
anticipates
that
nearly
350
SLN
applications
will
be
submitted
each
year
for
an
estimated
annual
burden
of
4,550
hours.
From
that,
EPA
estimates
that
each
State
will
receive,
on
average,
5
or
6
SLN
applications
per
year.
November
20,
2002
Page
11
of
26
(
iii)
Overall
Burden
The
overall
respondent
burden
associated
with
this
collection
is
estimated
to
be
18,200
hours
per
year.
Respondents
include
both
the
State
governments
and
the
companies
filing
for
State
registrations.
No
changes
have
been
made
in
the
requirements
for
Section
24(
c)
applications,
and
no
changes
have
been
made
to
the
provisions
of
this
information
collection
activity.

6(
b)
Estimating
Respondent
Cost
EPA
has
increased
its
estimated
labor
rates
for
applicants
and
State
government
personnel
factoring
in
an
inflation
cost
index
of
1.056
based
on
the
Gross
Domestic
Product.
These
labor
rates
are
fully
loaded
and
included
benefits
and
overhead
costs.
For
applicants,
EPA
estimates
labor
costs
of
$
130,
$
88
and
$
40
per
hour
for
management,
technical
and
clerical
burden,
respectively.
For
State
agency
personnel,
EPA
estimates
labor
costs
of
$
84,
$
63,
and
$
32
per
hour
for
management,
technical
and
clerical
burden,
respectively.
Using
the
Agency's
burden
estimates
and
the
fully
loaded
labor
rates,
the
Agency
estimates
the
applicant
costs
to
be
approximately
$
3,732
per
response
and
State
agency
costs
to
be
approximately
$
797
per
response
for
a
total
of
$
4,529
per
response.
The
overall
annual
cost
associated
with
this
information
collection,
based
on
an
estimate
350
responses
per
year,
is
estimated
to
be
$
1,585,150.
November
20,
2002
Page
12
of
26
RESPONDENT
BURDEN/
COST
ESTIMATES
PER
24(
c)
REGISTRATION
REGISTRANT
HOURS,
RATES
TOTAL
Collection
Activities
Mgmt.
$
130/
hr
Tech.
$
88/
hr.
Cler.
$
40/
hr.
Hours
Costs
($)

Gather
data
5.00
12.50
0.00
17.50
1,750
Submit
materials
to
State
9.00
5.50
1.00
15.50
1,694
Store/
file/
maintain
the
data
0.00
1.00
5.00
6.00
288
TOTAL
14.00
19.00
6.00
39.00
$
3,732
STATE
GOVERNMENT
HOURS,
RATES
TOTAL
Collection
Activities
Mgmt.
$
84/
hr
Tech.
$
63/
hr.
Cler.
$
32/
hr.
Hours
Costs
Compile
information
0.0
1.0
0.0
1.0
63.00
Review
submission
information
0.0
5.5
0.0
5.5
346.50
Complete
and
transmit
paperwork
to
EPA
(
including
label
revisions,
SLN
registration
cancellations,
and
other
follow­
up
actions)
0.0
5.4
0.4
5.8
353.00
Store/
file/
maintain
the
data
0.0
0.0
0.1
0.1
3.20
Respond
to
Registrant
(
if
necessary)
0.0
0.4
0.2
0.6
31.60
TOTAL
0.0
12.3
0.7
13
$
797.30
ANNUAL
BURDEN:
52
Total
Hours
x
350
Applications
=
18,200
hours
ANNUAL
COSTS:
$
4,529
x
350
Applications
=
$
1,585,150
November
20,
2002
Page
13
of
26
6(
c)
Estimating
Agency
Burden
and
Cost
The
Agency
technical
employee
burden
associated
with
the
24(
c)
registration
program
has
been
estimated
from
the
Time
Accounting
Information
System
(
TAIS)
and
OPP's
regulatory
action
resource
tracking
systems,
although
neither
management
nor
clerical
burden
is
captured
by
these
systems.
The
estimate
for
management
burden
is
based
on
the
assumption
that
only
a
small
portion
of
24(
c)
registrations
require
management
decisions,
usually
only
those
the
technical
staff
recommends
for
denial.
The
hours
associated
with
reviewing
the
data
submissions
and
publishing
summaries
have
been
revised
to
reflect
that
it
is
actually
the
data
review
portion
of
the
collection
activity
that
takes
the
most
time.
The
estimate
for
notifying
the
State
is
small
because
of
the
small
number
of
application
denials.

The
Agency
cost
associated
with
this
program
is
estimated
to
be
$
352,124
per
year.
The
labor
rates
are
based
on
Office
of
Personnel
Management
salary
tables
for
federal
employees
for
the
years
1999
through
2001
and
include
benefits
and
overhead
costs,
as
well
as
locality
pay
for
the
Washington,
DC­
Baltimore
area.
The
total
Agency
costs
also
include
FR
and
electronic
mailing
costs.

ANNUAL
AGENCY
BURDEN/
COST
ESTIMATES
PER
24(
c)
SUBMISSION
COLLECTION
ACTIVITIES
HOURS,
RATES
TOTAL
Mgmt.
$
96/
hr.
Tech.
$
70/
hr
Cler.
$
33/
hr.
Hours
Costs
Read
and
record
Statesubmitted
information
0.0
0.1
0.1
0.2
10.30
Review
data
submissions
0.6
11.0
0.0
11.6
827.60
Publish
summary
of
24(
c)
s
0.1
0.5
0.1
0.7
47.90
Store/
file/
maintain
the
data
0.0
0.0
0.1
0.1
3.30
Notify
the
State
(
if
necessary)
0.1
0.2
0.1
0.4
26.90
TOTAL
0.8
11.8
0.4
13.0
$
916
ANNUAL
BURDEN:
13
Total
Hours
x
350
Applications
=
4,550
Hours
ANNUAL
COSTS:
$
916
x
350
Applications
$
320,600
ANNUAL
MAILING
COSTS:
$
31,524
(
Federal
Register
mailing
costs
of
$
20,232
+
electronic
mail
costs
of
$
11,292)

TOTAL
ANNUAL
AGENCY
COSTS:
$
352,124
November
20,
2002
Page
14
of
26
6(
d).
Bottom
Line
Hours
And
Costs
MASTER
TABLE
TOTAL
Hours
Costs
Respondents
(
applicants
&
states)
18,200
$
1,585,150
Agency
4,550
$
352,124
6(
e)
Reasons
For
Changes
in
Burden
When
this
information
collection
activity
was
renewed
in
1996
and
1999,
the
Agency
included
burden
estimates
for
applicant
activities
to
conform
to
the
amended
Paperwork
Reduction
Act
requirements.
Based
on
their
expertise,
the
Agency's
staff
experts
estimated
at
the
time
that
the
applicant
paperwork
burden
was
approximately
68
hours
per
application.
The
Agency
did
not
receive
any
information
during
the
public
comment
period
for
this
renewal
that
indicated
a
revision
to
this
estimate
was
needed.
Information
received
by
the
Agency
during
consultations
with
applicants
indicated
that
previous
estimates
of
average
"
per­
application"
burden
were
too
high.
The
Agency
has
revised
the
estimated
applicant
burden
downward
to
approximately
39
hours
per
response
to
reflect
the
information
supplied
by
applicants.

While
EPA
revised
its
assessment
of
applicant
burden
downward
based
on
consultations
with
respondents,
the
Agency
revised
its
assessment
of
State
agency
burden
upward
in
response
to
respondent
feedback.
EPA
had
historically
estimated
the
to
burden
State
agencies
as
2.5
hours
per
response.
We
learned
during
our
consultation
with
our
State
partners
that
13
hours
per
response
is
a
more
accurate
assessment
of
burden.
Our
estimates
have
been
revised
to
reflect
the
discussions
with
respondents.

The
effect
of
these
revisions
to
our
burden
estimates
has
led
to
a
net
reduction
of
annual
respondent
burden
associated
with
this
collection
by
6,404
hours.
When
OMB
last
approved
this
information
collection
activity
in
1999,
the
Agency
estimated
the
annual
burden
to
equal
24,604
hours
annually.
This
renewal
ICR
reflects
a
29
hour
burden
decrease
per
response
for
applicants,
while
showing
a
11.5
hour
burden
increase
per
response
for
States.
This
6,404
hour
burden
decrease
represents
an
adjustment
to
EPA's
burden­
hour
estimate
in
the
current
ICR.

6(
f)
Burden
Statement
The
annual
respondent
burden
for
this
ICR
is
estimated
to
average
52
hours
per
response
(
39
hours
per
applicant
and
13
hours
per
State),
including
time
for
compiling
the
information/
data
submitted
by
the
registrant,
reviewing
the
information
for
special
local
needs
November
20,
2002
Page
15
of
26
determination,
completing
paperwork
to
notify
the
federal
government,
storing/
filing/
maintaining
the
data,
and
responding
back
to
the
registrant
if
the
registration
is
disapproved
by
EPA.
The
burden
estimate
includes
hours
spent
by
the
registrant
in
preparing
the
application
for
submission
to
EPA.

Send
comments
regarding
this
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
the
burden,
to:
Director,
Collection
Strategies
Division,
Mail
Code
2822,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW,
Washington,
DC
20460;
and
to
Paperwork
Reduction
Act
Project
(
OMB
No.
2070­
0055),
Office
of
Regulatory
Affairs,
Office
of
Management
and
Budget,
Washington,
DC
20503,
marked
"
Attention
Desk
Officer
for
EPA."
November
20,
2002
Page
16
of
26
ATTACHMENTS
TO
THE
SUPPORTING
STATEMENT
ATTACHMENT
A:
FIFRA
Section
24(
c)
(
7
U.
S.
C.
136v)
­
available
electronically
at
http://
www.
epa.
gov/
pesticides/
fifra.
htm#
sec24
ATTACHMENT
B:
FFDCA
Section
408
(
21
U.
S.
C.
346a)
­
available
electronically
at
http://
uscode.
house.
gov/
usc.
htm
ATTACHMENT
C:
66
FR
64249
­
FIFRA
Section
24(
c)
Special
Local
Need
Registrations;
Renewal
of
Pesticide
Information
Collection
Activities
and
Request
for
Comments
(
published
December
12,
2001)
­
available
electronically
at
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2001/
December/
Day­
12/
p30597.
htm
ATTACHMENT
D:
Public
Comment
Regarding
66
FR
64249
­
Comments
of
Mr.
Erik
Johansen,
Washington
State
Department
of
Agriculture
­
An
electronic
copy
of
this
attachment
follows
in
the
electronic
file
for
this
ICR.

ATTACHMENT
E:
Applicant
Estimates
of
Burden
­
Applicant
feedback
received
during
Agency
consultation
activities
­
An
electronic
copy
of
this
attachment
follows
in
the
electronic
file
for
this
ICR.

ATTACHMENT
F:
Application
for/
Notification
of
State
Registration
of
a
Pesticide
to
Meet
a
Special
Local
Need
(
EPA
Form
8570­
25)
­
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/
8570­
25.
pdf
ATTACHMENT
G:
Confidential
Statement
of
Formula
(
EPA
Form
8570­
4)
­
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/
8570­
4.
pdf
ATTACHMENT
H:
Display
Related
to
OMB
Control
#
2070­
0055
­
Listings
of
Related
Regulations
in
40
CFR
9.1
­
An
electronic
copy
of
this
attachment
follows
in
the
electronic
file
for
this
ICR.

ATTACHMENT
I:
40
CFR
162,
Subpart
D
­
STATE
REGISTRATION
OF
PESTICIDE
PRODUCTS:
Regulations
Pertaining
to
State
Registration
of
Pesticides
To
Meet
Special
Local
Needs
­
available
electronically
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr162_
00.
html
OMB
CONTROL
NO.
2070­
0055
ATTACHMENT
D
Public
Comment
Regarding
66
FR
64249
Comments
of
Mr.
Erik
Johansen,
Washington
State
Department
of
Agriculture
Comments
for
EPA
Public
Docket
re:
Docket
control
number
OPP­
00753,
ICR
for
FIFRA
Section
24(
c)
Special
Local
Need
Registrations
Washington
State
Department
of
Agriculture
(
WSDA)
issues
approx.
37
SLN
registrations
per
year
(
1999,
2000,
2001).
WSDA
revises
several
dozen
SLN
labels
per
year,
and
cancels
several
dozen
SLN
registrations
per
year.
WSDA
also
responds
to
several
requests
per
year
from
EPA
regarding
SLN
registrations
(
recommendations
for
label
revision,
requests
for
additional
information,
other
actions).
Therefore,
a
reasonable
estimate
is
that
WSDA
corresponds
with
EPA
approx.
75­
100
times
per
year
regarding
SLN
registrations.

The
Federal
Register,
December
12,
2001
(
Volume
66,
Number
239,
Page
64249­
64251)
indicates
in
Section
V
(
Burden
and
Cost
Estimates)
that
the
estimated
total/
average
number
of
responses
from
each
respondent
(
including
states)
is
1­
3.
This
estimate
appears
to
be
inaccurate.

Feel
free
to
contact
me
if
there
are
any
questions
regarding
these
comments.

Erik
W.
Johansen
Pesticide
Registration
Specialist
/
Pollinator
Protection
&
Spray
Adjuvants
Phone
(
360)
902­
2078
Fax
(
360)
902­
2093
email
ejohansen@
agr.
wa.
gov
OMB
CONTROL
NO.
2070­
0055
ATTACHMENT
E
Applicant
Estimates
of
Burden
Applicant
feedback
received
during
Agency
consultation
activities
Page
19
of
26
Generic
EPA
Request
for
Registrant
Feedback
on
Burden
for
FIFRA
24(
c)
Activities
Sent
via
e­
mail
by
Jim
Tompkins,
US
EPA/
Office
of
Pesticide
Programs,
on
11/
07/
2002
The
Agency
is
working
on
the
renewal
of
the
Information
Collection
Request
(
ICR)
for
24(
c)
s
under
which
the
Agency
is
given
authority
to
collect
the
information
submitted
with
a
24(
c)
registration.

As
part
of
the
24(
c)
ICR,
the
Agency
must
provide
an
estimate
of
the
burden
on
registrants
to
complete
a
24(
c)
registrations.
To
assist
EPA
in
providing
a
reasonable
estimate
of
the
burden
to
registrants
to
complete
a
24(
c)
registration,
I
am
requesting
that
you
provide
your
best
estimate
of
the
hours
in
each
category
to
complete
an
average
24(
c)
realizing
some
24(
c)
s
take
more
time
and
other
24(
c)
s
take
less
time.

We
will
then
average
the
responses
from
a
number
of
registrants
to
provide
OMB
with
a
reasonable
burden
estimates.
Nobody
is
sure
of
where
the
burden
estimates
in
the
current
ICR
came
from
so
it
is
time
for
a
little
reality
check.

Registration
Manager
Technical
Support
Clerical
Support
Gather
Data
Prepare
24(
c)
for
Submission
to
State
Clerical
typing
filing
etc.

Please
forward
this
message
to
the
appropriate
person.
If
possible,
I
need
a
response
by
November
14.

Thank
You
Jim
T
Page
20
of
26
­­­­­
Forwarded
by
Jim
Tompkins/
DC/
USEPA/
US
on
11/
20/
02
01:
34
PM
­­­­­

Jack
Cain
<
Jack.
Cain@
USA.
dupont.
com>
11/
13/
02
07:
36
AM
To:
Jim
Tompkins/
DC/
USEPA/
US@
EPA
cc:
Subject:
Re:
24(
c)
Burden
Estimate
Jim,

Based
on
input
from
other
2
other
Reg.
Managers
in
our
group,
our
State
Registration
coordinator
and
two
of
our
Field
Dev.
folks
(
tech
support)
we
came
up
with
the
following
#
s
(
note
they
are
averages
from
all
the
inputs
I
received).

Registration
Manager
Technical
Support
Clerical
Support
Gather
Data
4
hrs
12
hrs
Prepare
24(
c)
for
Submission
8
hrs
6
hrs
2
hrs
to
State
Clerical
typing
1.5
hrs
2
hrs
filing
etc.

Hope
this
helps,

Jack
Page
21
of
26
­­­­­
Forwarded
by
Jim
Tompkins/
DC/
USEPA/
US
on
11/
20/
02
01:
35
PM
­­­­­

Rebecca
L
Johnston
<
johnstrl@
basf­
corp.
com>
11/
12/
02
10:
51
AM
To:
Jim
Tompkins/
DC/
USEPA/
US@
EPA
cc:
Subject:
Re:
24(
c)
Burden
Estimate
Jim,

I
did
not
receive
a
confirmed
delivery
so
I
am
sending
again.

Rebecca
­­­­­
Forwarded
by
Rebecca
L
Johnston/
APN/
PRINCETON/
BASF­
CORP/
BASF
on
11/
12/
2002
10:
51
AM
­­­­­

Rebecca
L
Johnston
11/
08/
2002
03:
04
PM
To:
Tompkins.
Jim
cc:
Joseph
S
O'Grodnick,
Laura
A
Sears
Subject:
Re:
24(
c)
Burden
Estimate(
Document
link:
Rebecca
L
Johnston)

Jim,

Attached
is
BASF's
estimate
of
the
effort
required
to
prepare
a
24(
c)
application.

Any
questions,
please
do
not
hesitate
to
ask.

(
See
attached
file:
Information
Collection
Request
for
24.
doc)

Regards,

Rebecca
Page
22
of
26
BASF
Corporation
BASF
Information
Collection
Request
for
24(
c)
Registrations
Registration
Mgr
Technical
Support
Clerical
Support
Overall
Coordination
8
hours
Support/
Gather
Data
°
Label
°
Justification
°
Data
Summaries
16
hours
8
hours
8
hours
Prepare
Submission
°
Label
°
Justification
°
Data
Summaries
16
hours
8
hours
8
hours
Clerical
Activities
°
Applications
°
Cover
Memos
°
Duplication
°
Filing
16
hours
Total
=
approx.
11
days
(
88
hrs)

1
day
=
typical
8
hour
workday
Estimated
effort
assumes
the
maximum
requirements
and
a
first
time
24(
c)
application.

R.
Johnston
11/
8/
02
November
20,
2002
Page
23
of
26
26
Davis
Drive,
PO
Box
13528,
Research
Triangle
Park,
NC
27709­
3528
Telephone
(
919)
547­
2000
Page
24
of
26
­­­­­
Forwarded
by
Jim
Tompkins/
DC/
USEPA/
US
on
11/
20/
02
01:
37
PM
­­­­­

"
HEDGECOCK,
F
ANDY
[
AG/
1000]"
<
f.
andy.
hedgecock@
monsanto.
com>
11/
08/
02
12:
58
PM
To:
Jim
Tompkins/
DC/
USEPA/
US@
EPA
cc:
Subject:
FW:
24(
c)
Burden
Estimate
Jim,

Russ
asked
if
I
could
provide
a
response
on
this
for
Monsanto.
I've
made
an
estimate
of
the
average
time
spent
submitting
to
one
state
based
on
the
matrix
you
had
below
across
the
three
functional
types
and
three
process
pieces.

Registration
Manager
Technical
Support
Clerical
Support
Gather
Data
­
12
hours
­

Prepare
24(
c)
for
Submission
4
hours
­
­
to
State
Clerical
typing
­
­
1
hour
filing
etc.

Let
me
know
if
you
need
other
information.

Regards,
F.
Andy
Hedgecock
Director,
State
Regulatory
Affairs
Monsanto
Worldwide
Regulatory
Affairs
phone:
314/
694­
5486
cel:
314/
378­
5632
fax:
314/
694­
4028
email:
f.
andy.
hedgecock@
monsanto.
com
<
mailto:
f.
andy.
hedgecock@
monsanto.
com>
Page
25
of
26
­­­­­
Forwarded
by
Jim
Tompkins/
DC/
USEPA/
US
on
11/
20/
02
01:
43
PM
­­­­­

greg.
watson@
syngenta.
com
11/
08/
02
03:
59
PM
To:
Jim
Tompkins/
DC/
USEPA/
US@
EPA
cc:
Subject:
RE:
24(
c)
Burden
Estimate
Dear
Jim,

As
promised,
here
is
the
feedback
from
us
regarding
the
ICR:

Registration
Manager
Technical
Support*
Clerical
Support
Gather
Data
1
hour
10
hours
­

Prepare
SLN
for
Submission
8
hours
­
1
hour
to
State
Clerical
­
typing,
1
hour
­
1
hour
filing
etc.

*
includes
compiling
and
summarizing
internal
and
external
data,
calling
COI's,
etc.
It
does
not
include
conducting
efficacy
or
residue
field
trials
required
to
obtain
a
24c
registration.

Please
let
me
know
if
this
was
what
you
were
after
or
if
additional
information
is
needed.

Have
a
good
weekend,

Greg
November
20,
2002
Page
26
of
26
OMB
CONTROL
NO.
2070­
0055
ATTACHMENT
H
Display
Related
to
OMB
Control
#
2070­
0027
­
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
Good
Laboratory
Practice
Standards
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
160
State
Registration
of
Pesticide
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
162.153