Document ID: EPA-HQ-OPP-2003-0298-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-09-16T04:00Z

August
27,
2003
Draft
for
Public
Comment
1
Rule
entitled:
"
Regulations
Under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
for
Plant­
Incorporated
Protectants
(
Formerly
Plant­
Pesticides);
Final
Rule"
signed
01/
16/
2001
(
FR
citation
pending),
an
electronic
copy
of
which
is
available
at
http://
www.
epa.
gov/
scipoly/
6057­
7.
pdf.

Page
1
of
19
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
Identification
of
the
Information
Collection
1(
a)
Title
of
the
Information
Collection:
Plant­
Incorporated
Protectants;
CBI
Substantiation
and
Adverse
Effects
Reporting
Nos.
EPA
ICR
#
1693.04;
OMB
Control
#
2070­
0142
1(
b)
Short
Characterization/
Abstract
The
Environmental
Protection
Agency
(
EPA)
is
responsible
for
the
regulation
of
pesticides
as
authorized
by
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
Prior
to
EPA
granting
a
registration,
the
manufacturer
of
the
pesticide
must
demonstrate
to
the
Agency
that
the
use
of
the
pesticide
product
will
not
result
in
any
unreasonable
adverse
effects
to
humans
or
the
environment.
EPA
is
also
responsible
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
for
establishing
a
tolerance
or
exemption
from
the
requirement
of
a
tolerance
for
pesticide
residues
on
food
or
feed.

On
January
16,
2001,
the
Agency
promulgated
a
final
rule
that
addresses
the
regulatory
status
of
pesticidal
substances
that
are
produced
by
plants
(
plant­
incorporated
protectants).
1
The
final
rule
clarifies
regulatory
responsibilities
at
different
stages
of
field
testing
through
registration,
and
ultimate
sale
and
distribution,
regardless
of
whether
the
pesticidal
capabilities
evolved
in
the
plants,
were
introduced
by
plant
breeding
or
through
the
techniques
of
modern
biotechnology.
It
is
now
possible
to
introduce
into
plants,
e.
g.,
through
genetic
engineering,
mechanisms
of
pest
and
disease
control
strategies.
Therefore,
pesticidal
substances
that
are
produced
by
plants
can
be
diverse
and
can
potentially
originate
from
any
taxonomic
kingdom.
A
plant­
incorporated
protectant
is
being
defined
in
the
final
rule
as
"
the
pesticidal
substance
that
is
intended
to
be
produced
and
used
in
a
living
plant
and
the
genetic
material
necessary
for
the
production
of
such
a
substance."

The
final
rule
accomplishes
several
items;
first,
it
exempts
a
wide
range
of
plantincorporated
protectants
from
registration
requirements
under
FIFRA,
and,
second,
it
imposes
two
new
requirements
on
manufacturers
of
some
plant­
incorporated
protectants.
August
27,
2003
Draft
for
Public
Comment
Page
2
of
19
This
Information
Collection
Request
(
ICR)
only
covers
the
two
new
information
collection
related
provisions
contained
in
the
final
rule,
i.
e.,
the
provisions
that
requires
registrants
that
make
Confidential
Business
Information
(
CBI)
claims,
to
substantiate
such
claims
when
they
are
made,
and
the
provision
that
requires
manufacturers
of
plant­
incorporated
protectants
exempted
from
requirements
of
registration
under
the
final
rule
to
report
adverse
effects
to
the
Agency.
It
is
important
to
note
that
current
CBI
regulations
at
40
CFR
part
2
require
that
claimants
substantiate
their
CBI
claims
for
their
own
records
when
the
claim
is
made,
and
subsequently
provide
the
substantiation
to
EPA
only
if
requested.
The
substantiation,
however,
is
not
required
to
be
included
with
the
submission
to
EPA
in
which
the
CBI
claims
are
made.
The
burden
associated
with
the
existing
requirement
is
already
approved
by
OMB.
Although
the
final
rule
now
requires
the
claimant
to
include
the
substantiation
in
the
plant­
incorporated
protectant
related
submissions
to
EPA,
it
is
difficult
to
identify
any
additional
burden
that
such
a
requirement
might
actually
impose.
Nevertheless,
the
Agency
has
chosen
the
conservative
approach
of
including
potential
burden
and
costs
for
preparing
and
submitting
the
CBI
substantiation
at
the
time
of
submission
of
the
information
containing
the
CBI
claim
as
required
by
this
final
rule.
The
Agency
will
re­
evaluate
the
need
for
a
separate
burden
estimate
when
this
ICR
is
incorporated
with
the
existing
ICRs
at
the
time
of
its
renewal.

The
final
rule
does
not
otherwise
contain
any
new
information
collection
requirements
that
require
additional
review
and
approval
by
the
Office
of
Management
and
Budget
(
OMB)
under
the
Paperwork
Reduction
Act
(
PRA)
(
44
U.
S.
C.
3501
et
seq.)
in
accordance
with
the
procedures
at
5
CFR
1320.11.
The
clarifications
contained
in
the
final
rule
that
are
related
to
information
collection
activities
that
are
part
of
registration
activities,
e.
g.,
data
requirements
for
pesticide
registrations,
are
already
approved
by
OMB
under
the
PRA
and
that
approval
is
not
impacted
by
the
clarification
provided
in
the
final
rule.
Information
collection
activities
related
to
pesticide
registration
are
approved
under
OMB
Control
Nos.
2070­
0060,
2070­
0024,
2070­
0040.

This
ICR,
therefore,
discusses
the
paperwork
burdens
associated
with
the
new
requirement
for
registrants
to
substantiate
CBI
claims
when
they
are
made,
and
the
requirement
for
manufacturers
of
plant­
incorporated
protectants
exempted
from
registration
requirements
under
the
final
rule
to
report
adverse
effects
to
the
Agency
within
30
days.

2.
Need
for
and
Use
of
the
Collection
2(
a)
Need/
Authority
for
the
Collection
Although
FIFRA
requires
the
registration
of
most
pesticides,
it
also
authorizes
the
Agency's
regulation
of
unregistered
pesticides.
FIFRA
section
3(
a)
provides
that,
to
the
extent
necessary
to
prevent
unreasonable
adverse
effects
on
the
environment,
the
Administrator
may
limit
the
distribution,
sale,
or
use
of
any
pesticide
that
is
not
registered
under
section
3
of
FIFRA,
August
27,
2003
Draft
for
Public
Comment
Page
3
of
19
or
subject
to
an
experimental
use
permit
under
section
5
of
FIFRA,
or
subject
to
an
emergency
exemption
under
section
18
of
FIFRA.
Pesticides
that
are
"
not
registered"
include
pesticides
that
are
exempt
from
FIFRA
requirements
under
section
25(
b).

FIFRA
section
2(
bb)
defines
the
term
"
unreasonable
adverse
effects
on
the
environment"
to
mean:
"(
1)
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,
or
(
2)
a
human
dietary
risk
from
residues
that
result
from
a
use
of
a
pesticide
in
or
on
any
food
inconsistent
with
the
standard
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act"
(
7
U.
S.
C.
136(
bb)).

Section
25(
b)(
2)
of
FIFRA
allows
EPA
to
exempt,
by
regulation,
any
pesticide
from
some
or
all
of
the
requirements
of
FIFRA,
if
the
pesticide
is
of
a
character
which
is
unnecessary
to
be
subject
to
FIFRA
in
order
to
carry
out
the
purposes
of
that
Act
(
7
U.
S.
C.
136w(
b)(
2)).
EPA
interprets
FIFRA
section
25(
b)(
2)
to
authorize
EPA
to
exempt
a
pesticide
or
category
of
pesticides
that
EPA
determines
poses
a
low
probability
of
risk
to
the
environment,
and
that
is
not
likely
to
cause
unreasonable
adverse
effects
to
the
environment
even
in
the
absence
of
regulatory
oversight
under
FIFRA.

To
determine
whether
a
pesticide
qualifies
for
an
exemption
under
section
25(
b)(
2),
EPA
evaluates
both
the
potential
risks
and
benefits
of
the
use
of
the
pesticide.
In
evaluating
a
pesticide
under
the
first
exemption
criterion,
whether
use
of
the
pesticide
poses
a
low
probability
of
risk
to
the
environment,
EPA
considers
the
extent
of
the
potential
risks
caused
by
use
of
the
pesticide
to
the
environment,
including
humans
and
other
animals,
plants,
water,
air
and
land.
Potential
risks
to
humans
include
dietary
risks
as
well
as
non­
dietary
risks
such
as
those
resulting
from
occupational
or
residential
exposure
to
the
pesticide.
EPA
uses
the
FFDCA
section
408
standard
in
evaluating
dietary
risks.
EPA
will
not
exempt
pesticides
under
section
25(
b)(
2)
that
fail
the
low
probability
of
risk
criterion.

In
evaluating
a
pesticide
under
the
second
exemption
criterion,
whether
the
use
of
the
pesticide
is
likely
to
cause
unreasonable
adverse
effects
on
the
environment
even
in
the
absence
of
regulatory
oversight
under
FIFRA,
EPA
balances
all
the
potential
risks
to
human
health,
including
any
dietary
risks,
and
risks
to
the
remainder
of
the
environment
from
use
of
the
pesticide
against
the
potential
benefits
associated
with
its
use.
In
balancing
risks
and
benefits,
EPA
considers
the
economic,
social,
and
environmental
costs
and
benefits
of
the
use
of
the
pesticide.
If
the
pesticide
meets
both
exemption
criteria,
EPA
may
exempt
the
pesticide
from
regulation
under
FIFRA
section
25(
b)(
2).

Under
FFDCA
section
408(
a),
a
pesticide
chemical
residue
in
or
on
food
is
not
safe
unless
EPA
has
issued
either:
a
tolerance
for
the
residue
and
the
residue
is
within
the
tolerance
limits,
or
an
exemption
from
the
requirement
of
a
tolerance
for
the
residue
(
21
U.
S.
C.
August
27,
2003
Draft
for
Public
Comment
Page
4
of
19
346a(
a)(
1)).
FFDCA
section
408
authorizes
EPA
to
determine
a
residue
is
safe
and
exempt
from
the
requirement
of
a
tolerance
if
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"
(
21
U.
S.
C.
346a(
c)(
2)(
A)).
Section
408
of
the
FFDCA
also
directs
EPA
to
specifically
consider
harm
that
may
result
to
infants
and
children
as
a
result
of
pesticide
chemical
residues.

A
determination
that
a
pesticide
chemical
meets
the
safety
standard
of
section
408(
c)
of
the
FFDCA
may
also
be
relevant
to
whether
a
pesticide
qualifies
for
a
FIFRA
section
25(
b)(
2)
exemption
with
respect
to
human
health
risks
arising
from
other
routes
of
exposure.
However,
FIFRA
does
not
provide
for
exemption
of
a
pesticide
in
food
based
solely
upon
consistency
with
the
FFDCA
section
408
exemption
standard.
At
a
minimum,
EPA
also
must
evaluate
risks
arising
from
occupational
exposure
to
humans
and
determine
that
such
risks
meet
both
exemption
criteria.
In
addition,
EPA
must
evaluate
the
risks
to
the
environment
from
the
pesticide
and
determine
both
that
the
pesticide
poses
only
a
low
probability
of
environmental
risks,
and
that
use
of
the
pesticide
is
not
likely
to
cause
any
unreasonable
adverse
effects
on
the
remainder
of
the
environment
in
the
absence
of
regulation
under
FIFRA.

2(
a)(
ii)
Need
for
this
Collection
EPA
believes
that
requiring
the
substantiation
of
CBI
claims
for
plant­
incorporated
protectants
at
the
time
of
submission
to
the
Agency
will
help
ensure
a
timely
EPA
response
to
submissions
for
plant­
incorporated
protectants,
protect
the
public's
right
to
access
information
consistent
with
FIFRA,
and
ensure
that
information
qualifying
as
CBI
is
properly
protected
from
unauthorized
disclosures.
Since
registrants
are
already
required
to
ensure
that
CBI
claims
are
proper
prior
to
asserting
the
CBI
protection
for
information
submitted
to
EPA,
this
requirement
simply
affects
the
time
at
which
the
substantiation
is
submitted
to
the
Agency,
i.
e.,
it
requires
the
inclusion
of
this
substantiation
with
the
submission.

While
the
Agency's
analysis
of
the
potential
risks
and
benefits
of
plant­
incorporated
protectants
has
led
it
to
conclude
that
the
categories
of
plant­
incorporated
protectants
described
in
40
CFR
part
174,
subpart
B
warrant
exemption,
it
is
possible
that
there
may
be
unforeseeable
adverse
effects
to
human
health
or
the
environment
from
the
testing
and
use
of
otherwise
exempted
plant­
incorporated
protectants,
as
the
exemptions
at
subpart
B
are
broad
covering
literally
thousands
of
potential
substances,
some
of
which
under
certain
use
conditions
have
the
potential
to
be
toxic.
The
Agency
thus
includes
as
a
condition
of
exemption,
a
requirement
to
report
to
EPA
within
30
days
any
factual
adverse
effects
associated
with
these
otherwise
exempt
plant­
incorporated
protectants.
These
reporting
requirements
are
similar
to
reporting
requirements
imposed
on
registrants
under
FIFRA
section
6(
a)(
2)
for
registered
pesticides.
August
27,
2003
Draft
for
Public
Comment
Page
5
of
19
However,
since
the
6(
a)(
2)
reporting
requirement
applies
to
registered
pesticides
and
plantincorporated
protectants
are
exempted
from
registration
by
the
final
FIFRA
rule,
the
Agency
imposed,
under
FIFRA
section
3
and
25(
b)
authorities,
impose
a
separate
reporting
requirement
to
obtain
any
information
on
unforeseen
adverse
effects
from
the
exempted
plant­
incorporated
protectants.

2(
b)
Practical
Utility/
Users
of
the
Data
The
information
supplied
to
substantiate
claims
of
confidentiality
will
be
used
by
the
Agency
to
determine
whether
CBI
claims
comply
with
the
confidentiality
provisions
of
FIFRA.
Early
substantiation
of
CBI
claims
will
enable
the
Agency
to
release
information
promptly
supporting
plant­
incorporated
protectants
registration
decisions
without
delaying
registrations
to
obtain
CBI
substantiation
once
a
decision
has
been
made
to
register
a
plant­
incorporated
protectant
while
still
protecting
legitimate
CBI.

The
adverse
effects
reports
on
exempted
plant­
incorporated
protectants
will
be
utilized
by
the
Agency
to
evaluate
adverse
effects
to
determine
if
any
additional
regulatory
actions
are
warranted.
These
reports
will
also
enable
the
Agency
to
report
to
appropriate
oversight
bodies
and
the
public
its
evaluation
of
such
adverse
effects
and
will
help
support
any
additional
decision
on
regulatory
oversight.

3.
Non­
duplication,
Consultations,
and
Other
Collection
Criteria
3(
a)
Non­
duplication
EPA
is
the
Federal
agency
primarily
responsible
for
the
regulation
of
pesticides.
In
fulfilling
this
mission,
EPA
works
closely
with
the
U.
S.
Department
of
Agriculture
(
USDA)
which
has
responsibilities
under
the
Federal
Plant
Protection
Act
(
FPPA),
and
the
U.
S.
Food
and
Drug
Administration
(
FDA)
which
has
responsibilities
under
the
FFDCA.
EPA,
USDA
and
FDA
consult
and
exchange
information
when
such
consultation
is
helpful
in
resolving
safety
questions.
The
three
agencies
also
strive
for
consistency
between
programs
following
one
of
the
basic
tenets
of
the
Coordinated
Framework
for
Regulation
of
Biotechnology
(
51
FR
23302
June
26,
1986);
i.
e.,
that
the
agencies
composing
the
Framework
adopt
consistent
approaches,
to
the
extent
permitted
by
the
respective
statutory
authorities.
A
consistent
approach
between
agencies
is
easier
for
the
regulated
community
to
understand.
It
is
also
more
likely
to
conserve
resources
as
submitters
would
more
likely
be
able
to
use
data
developed
for
one
agency
to
meet
requirements
posed
by
another
agency
for
the
same
or
similar
products.

Generally,
respondents
are
not
required
to
submit
applications
or
any
other
related
data
or
information
regarding
testing
to
any
other
federal
agency
or
to
any
other
EPA
program
office.
August
27,
2003
Draft
for
Public
Comment
Page
6
of
19
However,
there
may
be
requirements
under
the
FPPA
for
plants
that
produce
plant­
incorporated
protectants.
Under
the
FPPA,
the
USDA's
Agriculture
and
Plant
Health
Inspection
Service
(
APHIS)
regulates
field
testing
of
genetically
altered
plants,
while
EPA
will
have
regulatory
oversight
of
the
pesticide
substances
produced
by
those
plants.
In
instances
where
review
under
the
FPPA
may
be
triggered,
the
respondent
will
need
to
contact
APHIS
for
a
determination
of
whether
the
plant
containing
a
plant­
incorporated
protectant
is
a
plant
pest
that
will
need
a
permit.

In
any
case,
there
is
no
known
duplication
related
to
the
requirements
covered
in
this
ICR,
i.
e.,
the
up­
front
CBI
substantiation
or
the
submission
of
adverse
effects
reports
for
exempted
plant­
incorporated
protectants.
Each
respondent
must
submit
information
unique
to
his/
her
product
application,
or
allegation
received,
and
will
do
so
only
once
on
occasion.

3(
c)
Consultations
The
final
rule
is
an
additional
step
in
fully
implementing
the
Untied
States'
"
Coordinated
Framework
for
Regulation
of
Biotechnology,"
which
was
issued
by
the
President's
Office
of
Science
and
Technology
Policy
(
OSTP)
on
June
26,
1986,
after
considerable
public
participation
(
51
FR
23302).

EPA
sponsored,
or
cosponsored
with
other
Federal
agencies,
three
conferences
dealing
with
plant
related
issues:
on
October
19­
21,
1987,
a
meeting
on
"
Genetically
Engineered
Plants:
Regulatory
Considerations"
at
Cornell
University,
Ithaca,
New
York;
on
September
8­
9,
1988,
a
"
Transgenic
Plant
Conference"
in
Annapolis,
Maryland;
on
November
6­
7,
1990,
a
conference
on
"
Pesticidal
Transgenic
Plants:
Product
Development,
Risk
Assessment,
and
Data
Needs"
in
Annapolis,
Maryland.
Information
from
these
conferences
has
been
incorporated
as
appropriate
in
development
of
this
rule.

In
developing
its
approach
to
plant­
incorporated
protectants,
EPA
requested
advice
from
two
scientific
advisory
groups
at
three
meetings.
On
December
18,
1992,
a
Subpanel
of
the
FIFRA
Scientific
Advisory
Panel
(
SAP)
was
convened
to
review
a
draft
proposed
policy
statement
and
to
answer
a
series
of
scientific
questions
concerned
primarily
with
EPA's
proposed
exemptions
under
FIFRA.
On
July
13,
1993,
a
Subcommittee
of
the
EPA
Biotechnology
Science
Advisory
Committee
(
BSAC)
was
convened
to
address
a
series
of
scientific
questions
concerned
primarily
with
EPA's
proposed
exemptions
under
the
FFDCA.
On
January
21,
1994,
a
joint
meeting
of
the
Subpanel
of
the
SAP
and
the
BSAC
Subcommittee
was
convened
to
address
a
series
of
scientific
questions
on
approaches
to
plant­
incorporated
protectants
under
both
FIFRA
and
FFDCA.
Advice
from
these
scientific
advisory
groups
was
considered
in
finalizing
this
rule.

EPA
published
in
the
November
23,
1994,
Federal
Register
a
package
of
five
separate
documents
(
59
FR
60496,
60519,
60535,
60542
and
60545)
which
described
EPA's
policy
and
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proposals
for
plant­
pesticides
(
now
called
plant­
incorporated
protectants)
under
FIFRA
and
FFDCA.
On
July
22,
1996,
EPA
published
a
supplemental
document
in
the
Federal
Register
(
61
FR
37891)
on
one
aspect
of
its
November
23,
1994,
Federal
Register
documents;
i.
e.,
how
the
concept
of
inert
ingredient
relates
to
plant­
pesticides
(
now
called
plant­
incorporated
protectants).

In
August
of
1996,
Congress
enacted
the
Food
Quality
Protection
Act
(
FQPA)
which
amended
FFDCA
and
FIFRA.
On
May
16,
1997,
EPA
published
in
the
Federal
Register
supplemental
documents
(
62
FR
27132
and
27142)
to
provide
the
public
with
an
opportunity
to
comment
on
EPA's
analysis
of
how
certain
FQPA
amendments
to
FFDCA
and
FIFRA
apply
to
the
proposed
exemptions
from
the
FFDCA
requirement
of
a
tolerance
for
two
categories
of
residues.

On
April
23,
1999,
EPA
published
a
supplemental
document
(
64
FR
19958)
soliciting
comment
on
whether
to
change
the
name
of
this
type
of
pesticide.

EPA
has
also
held
workshops
and
other
meetings
to
assist
the
regulated
community
and
others
to
understand
its
1994
proposal.
For
example,
a
workshop
was
held
in
Washington
D.
C.,
on
July
17­
18,
1997.

The
documents
and
reports
of
the
meetings
described
above
are
available
in
the
record
for
the
rule
for
plant­
incorporated
protectants
In
addition
to
the
public
consultation
described
above,
consultation
and/
or
dialogue
between
industry
and
the
BPPD
Managers
occurs
on
an
informal,
on­
going,
as­
needed
basis,
during
the
submission
and
review
of
an
application
for
EUP
or
registration.
Experience
has
shown
that
if
any
sort
of
problem,
be
it
technical,
administrative,
or
otherwise,
arises
or,
if
there
are
suggestions
for
improvements
in
the
program,
the
applicants
will
not
hesitate
to
inform
BPPD.
Any
questions
or
consultations
connected
with
a
particular
submission
are
addressed
in
a
meeting
or
telephone
conversation
with
the
applicant,
and
do
not
necessarily
occur
at
specified
intervals.

3(
d)
Effects
of
Less
Frequent
Collection
Not
applicable.
The
information
is
submitted
either
in
conjunction
with
the
application
or
when
an
adverse
effect
occurs
for
an
exempted
plant­
incorporated
protectant.
This
activity
is
conducted
only
once
per
"
event,"
and
therefore,
there
are
no
set
means
by
which
the
Agency
can
reduce
the
frequency.

3(
e)
General
Guidelines
August
27,
2003
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19
The
collection
activities
covered
by
this
ICR
comply
with
the
PRA
guidelines
established
by
OMB.

3(
f)
Confidentiality
Although
the
EPA
urges
the
submitter
to
minimize
the
amount
of
information
that
is
claimed
as
CBI,
any
data
and/
or
information
submitted
to
the
Agency
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
regulations
as
contained
in
40
CFR
Part
2,
Subpart
B.
When
information
that
is
claimed
as
trade
secret
or
CBI
is
provided
to
the
Agency,
such
information
is
subject
to
the
protections
and
procedures
set
forth
in
FIFRA
Section
10.
Nothing
in
this
rule
affects
those
protections.

Even
if
a
registrant
fails
to
include
the
required
substantiation
for
any
CBI
claims
made
in
the
plant­
incorporated
protection
application
when
that
application
is
submitted
to
EPA,
the
Agency
intends
to
still
handle
such
claims
in
accordance
with
the
FIFRA
Confidential
Business
Information
Security
Manual.
This
manual
contains
instructions
relative
to
all
contact
with
confidential
documents,
including
responsibility
of
EPA
employees,
physical
security
measures,
CBI
materials
within
EPA,
CBI
typing
procedures
(
documents
typed
internally
or
by
contract),
and
interdivisional
routing
procedures.
The
manual
dictates
all
CBI
must
be
marked
or
flagged
as
such,
that
it
must
be
kept
in
secure,
i.
e.,
double­
locked
areas,
and
that
all
CBI
to
be
destroyed
must
be
cleared
by
a
document
control
officer
and
placed
in
the
EPA's
paper
shredder.

3(
g)
Sensitive
Questions
Not
applicable.
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
The
respondents
for
the
information
collection
activities
contained
in
this
ICR
include
producers
and
importers
of
plant­
incorporated
protectants.
These
entities
may
be
classified
under
the
following
North
American
Industrial
Classification
System
(
NAICS)
codes:
32532
(
Pesticides
and
Other
Agricultural
Chemical
Manufacturing),
54171
(
Research
and
Development
in
the
Physical,
Engineering
and
Life
Sciences,
325414
(
Biological
Products
(
except
Diagnostic)
Manufacturing,
611310
(
Colleges,
Universities,
and
Professional
Schools),
422910
(
Farm
Supplies
Wholesalers),
and
422930
(
Flower,
Nursery
Stock,
and
Florists'
Supplies
wholesalers).
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4(
b)
Information
Requested
4(
b)(
i)
Data
items,
including
record
keeping
requirements
Registrants
must
continue
to
review
the
regulations
regarding
CBI,
review
the
materials
in
their
submission
for
which
claims
are
being
made;
and
ensure
that
CBI
claims
are
properly
made.
Pursuant
to
the
final
rule,
registrants
must
submit
a
substantiation
for
any
CBI
claim
made
for
information
for
plant­
incorporated
protectants
submitted
to
EPA.
The
Agency
is
not
imposing
any
new
requirements
regarding
the
basis
for
making
a
CBI
claim,
or
the
points
that
must
be
addressed
to
substantiate
any
CBI
claim
that
is
made.
These
requirements
already
exist
in
40
CFR
part
2.
In
addition,
EPA
is
not
imposing
any
specific
form
or
format
for
these
substantiations.
(
See
40
CFR
174.9)

Manufacturers
of
plant­
incorporated
protectants
exempted
from
registration
requirements
(
i.
e.,
those
exempted
under
FIFRA
section
25(
b)
in
the
final
rule),
must
submit
to
EPA
any
information
they
subsequently
obtain
regarding
adverse
effects
on
human
health
or
the
environment
alleged
to
have
been
caused
by
the
exempted
plant­
incorporated
protectant.
The
Agency
anticipates
that
the
entities
will
obtain
adverse
effects
information
during
the
normal
course
of
business,
and
then
will
make
a
report
to
the
Agency
with
adequate
background
information
for
the
Agency
to
be
able
to
make
a
decision
to
either
ask
for
additional
information
or
to
act
on
the
information
presented.
The
Agency
does
not
foresee
any
extra
data
collection
effort
to
find
adverse
effects
beyond
the
normal
course
of
business
but
rather
envisions
these
effects
being
discovered
from
ongoing
studies
of
various
plant­
incorporated
protectants
or
customer
complaints.
Although
EPA
specifies
the
content
of
any
adverse
effects
report
submitted
to
EPA,
EPA
is
not
imposing
any
specific
form
or
format
for
these
reports.
(
See
40
CFR
174.71)

In
addition,
entities
may
also
be
asked
to
respond
to
Agency
questions
that
arise
based
on
the
submission,
whether
it
be
the
CBI
substantiation,
or
the
adverse
effects
report.
Such
followup
activities
are
assumed
as
part
of
the
initial
burden
estimates.
Should
further
information
be
necessary,
e.
g.,
should
the
adverse
effect
information
reported
to
EPA
indicate
the
need
for
a
study
or
other
additional
information,
any
additional
Agency
requirement
would
come
in
the
form
of
either
a
data
call
in
covered
under
existing
regulations
or
new
regulations.
This
ICR
is
not
intended
to
address
such
activities.

4(
b)(
ii)
Respondent
Activities
The
requirements
for
up­
front
CBI
substantiation
and
adverse
effects
reporting
are
separate
requirements
that
only
occur
on
occasion.
The
CBI
substantiation
occurs
when
an
entity
is
submitting
plant­
incorporated
protectant
related
information
to
EPA
that
contains
CBI
claims
pursuant
to
40
CFR
part
2.
The
adverse
effects
reporting
occurs
when
an
entity
obtains
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information
regarding
adverse
effects
on
human
health
or
the
environment
alleged
to
have
been
caused
by
the
exempted
plant­
incorporated
protectant.

Although
each
activity
is
distinct,
a
representative
respondent
for
each
activity
is
expected
to
engage
in
the
following
activities:

Read
Regulations
The
respondent
needs
to
become
familiar
with
the
regulations
governing
CBI
substantiation
and
adverse
effects
reporting
as
they
pertain
to
plantincorporated
protectants.

Plan
Activities
The
respondent
must
develop/
amend
and
implement
a
plan
to
ensure
compliance
with
these
requirements.
The
registrant
is
also
encouraged
to
consult
with
the
Agency.

Gather
Information
The
information
necessary
to
provide
the
required
substantiation
and
any
information
obtained
on
adverse
effects
must
be
assembled.

Review
Information
The
respondent
must
check
the
CBI
substantiation
for
accuracy
and
completeness,
and
verify
that
the
adverse
effects
report
accurately
reflects
the
information
they
have
obtained.

Complete
Paperwork
The
information
must
be
compiled
into
a
document(
s)
or
report(
s)
and
prepared
for
submission
to
EPA.

Submit
Information
The
respondent
must
submit
the
information
to
the
Office
of
Pesticide
Programs
as
required.

Store,
Maintain,
and
File
Information
The
final
rule
does
not
contain
any
new
recordkeeping
requirements.
Please
note
however
that
FIFRA
section
8,
and
the
related
regulations
in
40
CFR
part
169,
require
registrants
to
store
and
maintain
certain
information
related
to
their
pesticide
products.
Since
no
new
recordkeeping
requirements
are
being
imposed
by
this
rule,
EPA
did
not
include
any
related
burden
in
this
ICR.

5.
The
Information
Collected­­
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
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The
Agency
must
evaluate
the
CBI
substantiations
when
submitted,
and
process
any
adverse
effect
reports
for
exempted
plant­
incorporated
protectants
when
received.
Although
these
activities
are
distinct
and
separate,
the
Agency
is
expected
to
engage
in
the
following
activities:

Consult
With
the
Registrant
The
Agency
will
respond
to
any
questions
either
in
writing,
or
verbally
via
meetings
or
by
telephone,
and
provide
any
other
assistance
or
guidance
requested.

Record
Submissions
Whether
the
submission
involves
an
application
package
for
the
registration
of
a
plant­
incorporated
protectant,
or
an
adverse
effects
report
for
allegations
related
to
an
exempted
plant­
incorporated
protectant,
the
submission
is
recorded
or
logged
in
by
the
Agency
to
document
its
receipt.
The
Agency
will
enter
the
necessary
information
into
the
computer
for
routing
and
tracking
purposes
Review
Submissions
The
Agency
will
review
the
incoming
materials
with
CBI
claims
to
evaluate
the
CBI
substantiations
for
completeness
and
appropriateness,
and
will
review
the
incoming
adverse
effects
reports
to
determine
what,
if
any,
substantive
review
or
action
might
be
necessary
as
follow
up
to
the
alleged
adverse
effects.

Store
the
Information
The
Agency
will
maintain
the
information
contained
in
the
submitted
application
package,
including
the
CBI
substantiation
that
was
submitted,
and
will
maintain
any
adverse
effects
report(
s)
submitted.

5(
b)
Collection
Methodology
and
Management
All
information
received
by
the
Agency
pertaining
to
CBI
substantiation
or
adverse
effects
for
exempted
plant­
incorporated
protectants
will
be
routed
to
the
Biopesticides
and
Pollution
Prevention
Division
(
BPPD)
of
the
Office
of
Pesticide
Programs
(
OPP).
It
will
be
pin­
punched
by
date,
screened,
and
entered
into
the
Pesticide
Regulatory
Action
Tracking
System
(
PRATS).

For
registration
packages
involving
plant­
incorporated
protectants,
a
file
will
be
created
and
the
application
package
will
be
forwarded
to
the
appropriate
Manager
within
BPPD.
The
Manager
assures
that
the
initial
PRATS
entry
is
correct,
reviews
the
information,
and
if
necessary,
routes
the
submitted
data
through
scientific
and/
or
administrative
review.
If
the
scientific
information
indicate
that
the
submission
is
deficient
in
any
manner,
the
submitter
has
the
option
of
attempting
to
correct
the
deficiency.
If
the
submission
indicates
that
information
claimed
as
CBI
warrants
said
claim,
the
applicant
is
notified
and
the
information
is
marked
as
such.
The
Agency
August
27,
2003
Draft
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19
will
continue
current
practice
of
treating
information
claimed
as
CBI
as
such,
until
a
CBI
determination
is
made.
If
a
determination
is
made
that
a
CBI
claim
is
not
warranted
or
the
claim
is
not
substantiated,
the
registrant
will
be
notified
that
the
information
claimed
as
CBI,
does
not
qualify
as
CBI
because
it
does
not
meet
the
regulatory
requirements.
They
will
be
given
an
opportunity
to
respond
as
provided
in
the
existing
regulations.
The
package
will
then
be
processed
accordingly.

For
adverse
effects
reports
related
to
exempted
plant­
incorporated
protectants,
a
file
will
be
created
and
the
report
will
be
forwarded
to
the
appropriate
product
Manager
within
BPPD.
The
Manager
assures
that
the
initial
PRATS
entry
is
correct,
reviews
the
information,
and
determines
the
appropriate
review
and
next
steps
based
on
the
contents
of
the
report,
routing
the
report
through
scientific
and/
or
administrative
review,
as
appropriate.
If
an
adverse
effect
report
indicates
that
additional
action
is
warranted
or
necessary,
the
Agency
will
take
appropriate
action.

5(
c)
Small
Entity
Flexibility
In
promulgating
the
final
rule,
the
Agency
considered
potential
small
entity
impacts,
and
has
taken
steps
to
minimize
potential
impacts
to
the
extent
permitted.
EPA
believes
that
the
CBI
substantiation
is
fairly
easy
to
provide
for
information
which
warrants
CBI
claims.
The
entity,
regardless
of
size,
is
already
required
to
make
the
CBI
determination
prior
to
submitting
its
application
to
EPA.
The
final
rule
simply
requires
that
this
determination
be
provided
with
the
submission
to
substantiate
the
CBI
claim.
This
is
reflected
in
the
relatively
low
cost
estimate
for
CBI
substantiation
for
a
plant­
incorporated
protectant
submission.
This
relatively
small
cost
represents
a
reasonable
step
to
insure
the
public
has
access
to
all
non
confidential
information
on
plant­
incorporated
protectants
once
they
are
registered.

In
addition,
the
Agency
has
taken
steps
to
ensure
that
only
the
person
who
produces
for
sale
and
distribution
the
exempted
plant­
incorporated
protectant
is
responsible
for
adverse
effects
reporting,
and
only
if
they
obtain
the
adverse
effects
information.
The
Agency
has
designed
such
reporting
to
be
minimal
and
has
placed
the
burden
on
the
Agency
to
take
additional
action
beyond
the
entity
making
the
report.

5(
d)
Collection
Schedule
The
CBI
substantiation
occurs
only
upon
submission
of
claims
of
confidentiality
and
the
adverse
effects
reporting
only
occur
on
occasion.
There
is
no
collection
schedule
associated
with
these
collection
activities.
These
activities
are
conducted
once
per
submission.

6.
Estimating
the
Burden
and
Cost
of
the
Collection
August
27,
2003
Draft
for
Public
Comment
Page
13
of
19
6(
a)
Estimating
Respondent
Burden
Burdens
for
this
analysis
are
relatively
straightforward
and
consist
primarily
of
the
administrative
burden
associated
with
the
drafting
and
submission
of
the
CBI
substantiation
and
the
adverse
effects
reports.
The
burden
estimates
are
based
on
the
Agency's
experience
regarding
existing
burden
estimates
related
to
CBI
substantiation
and
adverse
effects
reporting
for
conventional
pesticides,
and
provides
reasonable
estimates
for
the
average
time
necessary
to
perform
each
activity
for
each
submission.

6(
b)
Estimating
Respondent
Costs
The
respondent
costs
for
these
activities
were
developed
by
using
the
loaded
hourly
labor
costs
reflected
in
the
Economic
Analysis
that
was
performed
for
the
final
rule.
The
value
of
labor
per
hour
for
management,
technical,
and
clerical
that
was
used
in
the
ICR
has
been
rounded
off
and
is
$
130,
$
88,
and
$
40
respectively.
The
hourly
rate
includes
overhead
and
benefits.
August
27,
2003
Draft
for
Public
Comment
Page
14
of
19
The
following
tables
illustrate
the
estimated
average
burden
and
costs
for
each
submission
event.

Table
1
­
Average
Burden
and
Cost
Estimates
for
a
Substantiation
of
CBI
Claims
Made
in
a
Plant­
Incorporated
Protectant
Submission
Burden
and
Cost
Estimates
Totals
Activities
Mgmt.
($
130/
hr)
Tech.
($
88/
hr)
Clerical
($
40/
hr)
Burden
(
hrs)
Costs
($)

Read
Regulations
1
($
130)
2
($
176)
0
3
$
306
Plan
Activities
2
($
260)
4
($
352)
0
6
$
612
Gather
Information
0
4
($
352)
0
4
$
352
Review
Information
2
($
260)
1
($
88)
1
($
40)
4
$
388
Complete
Paperwork
0
1
($
88)
2
($
80)
3
$
168
Submit
Information
0.5
($
65)
0.5
($
44)
0.5
($
20)
1.5
$
129
Totals
5.5
($
715)
12.5
($
1100)
3.5
($
140)
21.5
$
1,955
Table
2
­
Average
Burden
and
Cost
Estimates
for
Submitting
an
Adverse
Effects
Report
for
an
Exempt
Plant­
Incorporated
Protectant
Burden
and
Cost
Estimates
Totals
Activities
Mgmt.
($
130/
hr)
Tech.
($
88/
hr)
Clerical
($
40/
hr)
Burden
(
hrs)
Costs
($)

Read
Regulations
0.5
($
65)
1
($
88)
0
1.5
$
153
Plan
Activities
0.5
($
65)
0.5
($
44)
0
1
$
109
Gather
Information
0
1
($
88)
0
1
$
88
Review
Information
0.5
($
65)
0.5
($
44)
0
1
$
109
Complete
Paperwork
0
0.5
($
44)
1
($
40)
1.5
$
84
Submit
Information
0
0.5
($
44)
0.5
($
20)
1.5
$
64
Cost
for
Mailing
0
0
0
0
$
0.37
Totals
1.5
($
195)
4
($
352)
1.5
($
60)
7
$
607
August
27,
2003
Draft
for
Public
Comment
Page
15
of
19
These
per
event/
submission
estimates
were
then
multiplied
by
the
estimated
the
number
of
events
(
i.
e.,
the
number
of
applications
for
plant­
incorporated
protectants
might
be
submitted
to
EPA
each
year,
and
the
number
of
adverse
effects
report
for
the
exempted
plant­
incorporated
protectants
might
be
submitted
to
EPA
each
year).
As
described
in
the
Economic
Analysis
for
the
final
rule,
EPA
estimates
that
as
many
as
14
applications
for
plant­
incorporated
protectants
might
be
submitted
to
EPA
in
the
first
few
years
of
implementation,
which
is
estimated
to
increase
over
several
years
to
44
applications
in
year
10.
For
purposes
of
this
ICR,
EPA
is
assuming
no
more
than
14
applications
will
be
submitted
over
the
3
year
approval
period
for
this
ICR.
Assuming
that
each
of
these
applications
involves
CBI
claims
for
which
substantiation
must
be
provided,
the
total
annual
average
burden
and
costs
for
the
CBI
substantiation
is
as
follows:

Estimated
Total
Annual
Burden
Hours:
14
events
x
21.5
hours
=
301
hrs.
Estimated
Total
Annual
Burden
Costs:
14
events
x
$
1,955
=
$
27,370
Since
these
substantiations
are
simply
added
to
the
application
package
and
are
not
submitted
separately,
there
are
no
additional
costs
related
to
the
transmittal
of
this
information
to
the
Agency.
The
costs
for
submitting
the
application
package
are
already
included
under
the
existing
ICRs.

This
respondent
burden
and
cost
estimates
may
also
represent
an
upper
bound
because
the
analysis
assumes
that
all
plant­
incorporated
protectant
related
applications
will
include
information
that
the
registrants
will
claim
as
CBI
which
will
need
to
substantiated.
It
is
likely
that
registrants
will
recognize,
over
time,
that
it
is
in
their
interest
to
make
all
information
on
plantincorporated
protectants
publicly
available
to
reduce,
if
not
eliminate,
the
negative
impressions
of
genetically
modified
foods.

Although
the
Agency
does
not
anticipate
any
adverse
effect
reports
to
be
submitted
for
exempted
plant­
incorporated
protectants,
this
ICR
includes
an
estimate
for
one
such
report
being
submitted
over
the
three
year
approval
period
for
this
ICR.
The
per
submission
estimate
is
therefore
divided
by
3
to
provide
an
average
annual
burden
and
cost
to
include
in
the
total
estimates
for
this
ICR.
The
total
annual
average
burden
and
costs
for
the
adverse
effects
report
is
calculated
as
follows:

Estimated
Total
Annual
Burden
Hours:
(
1
event
x
7.5
hours)
÷
3
=
2.5
hours
Estimated
Total
Annual
Burden
Costs:
(
1
event
x
$
607
÷
3
=
$
202.33
In
addition
to
these
per­
activity
burdens
and
costs,
EPA
estimates
that
most
pesticide
registrants
will
read
this
rule
after
issuance,
regardless
of
immediate
intentions
to
submit
information
related
to
a
plant­
incorporated
pesticide.
EPA
has
therefore
estimated
burden
and
costs
for
general
rule
familiarization
during
the
first
year
of
implementation.
EPA
estimates
an
average
of
2
hours
(
technical
person
level
@
$
88/
hour)
for
general
rule
familiarization,
and
that
August
27,
2003
Draft
for
Public
Comment
Page
16
of
19
an
average
of
60%
of
the
approximately
2,500
registrants
(
i.
e.,
1,600
registrants)
may
read
the
rule
for
familiarization
with
these
requirements.
Since
this
general
rule
familiarization
is
only
applicable
during
the
first
year
of
implementation,
this
burden
and
cost
is
divided
by
3
to
provide
an
annual
burden
and
cost
estimate
to
include
in
the
total
burden
and
costs
for
this
ICR.
The
annual
average
burden
and
costs
for
initial
rule
familiarization
is
as
follows:

Estimated
Total
Annual
Burden
Hours:
(
1,600
respondents
x
2
hours)
÷
3
=
1,067
hours
Estimated
Total
Annual
Burden
Costs:
(
1,600
respondents
x
$
176)
÷
3
=
$
93,866
6(
c).
Estimating
Agency
Burden
and
Costs
The
Agency
will
incur
burden
and
costs
while
performing
the
various
activities
necessary
to
review
CBI
substantiation
submissions
and
any
adverse
effects
reports
submitted
for
exempted
plant­
incorporated
protectants.
These
activities
are
described
in
Chapter
4
of
this
ICR
and
may
include
the
tracking
and
review
of
submissions,
requests
for
additional
information,
consultations
with
applicants,
etc.

Tables
3
and
4
provide
the
average
annual
burden
and
cost
estimates
for
the
Agency's
activities
for
the
first
3
years
of
implementation.
The
cost
estimates
in
this
table
were
calculated
using
the
following
government
wage
rates
and
labor
classification:
$
96
for
management,
$
70
for
technical,
and
$
33
for
clerical.
These
rates
were
adjusted
to
account
for
benefits
and
overhead,
and
rounded
off
for
ease
of
calculation.

Table
3
­
Average
Burden
and
Cost
Estimates
for
EPA
Activities
related
to
a
CBI
Substantiation
Burden
and
Cost
Estimates
Totals
Activities
Mgmt.
($
96/
hr)
Tech.
($
70/
hr)
Clerical
($
33/
hr)
Burden
(
hrs)
Costs
($)

Consult
With
the
Registrant
1
($
96)
3
($
210)
0.5
($
16.50)
4.5
$
323
Record
Submissions
0
0.5
($
35)
1
($
33)
1.5
$
68
Review
Submissions
1
($
96)
2
($
140)
0
3
$
236
Store
the
Information
0
0.5
($
35)
1
($
33)
1.5
$
68
Totals
2
($
192)
6
($
420)
2.5
($
83)
10.5
$
695
Assuming
that
each
of
the
14
applications
expected
in
the
next
3
years
involves
CBI
claims
for
which
substantiation
must
be
reviewed
by
EPA,
the
total
annual
average
burden
and
costs
for
Agency
to
process
the
CBI
substantiations
under
this
ICR
is
as
follows:
August
27,
2003
Draft
for
Public
Comment
Page
17
of
19
Estimated
Total
Annual
Burden
Hours:
14
events
x
10.5
hours
=
147
hrs.
Estimated
Total
Annual
Burden
Costs:
14
events
x
$
695
=
$
9,730
Table
4
­
Average
Burden
and
Cost
Estimates
for
EPA
Activities
related
to
an
Adverse
Effects
Report
Submitted
for
an
Exempt
Plant­
Incorporated
Protectant
Burden
and
Cost
Estimates
Totals
Activities
Mgmt.
($
96/
hr)
Tech.
($
70/
hr)
Clerical
($
33/
hr)
Burden
(
hrs)
Costs
($)

Consult
With
the
Registrant
0.5
($
48)
1
($
70)
0.5
($
16.50)
2
$
134.50
Record
Submissions
0
0.5
($
35)
1
($
33)
1.5
$
68
Review
Submissions
1
($
96)
1
($
70)
0
2
$
166
Store
the
Information
0
0.5
($
35)
0.5
($
16.50)
1
$
51.50
Totals
1.5
($
144)
3
($
210)
2
($
66)
6.5
$
420.00
Assuming
a
single
adverse
effects
report
might
be
submitted
over
the
3
year
approval
period
for
the
ICR,
the
total
annual
average
burden
and
costs
for
EPA
activities
related
to
the
adverse
effects
report
is
calculated
as
follows:

Estimated
Total
Annual
Burden
Hours:
(
1
event
x
6.5
hours)
÷
3
=
2.17
hours
Estimated
Total
Annual
Burden
Costs:
(
1
event
x
$
420.00)
÷
3
=
$
140.00
In
addition,
the
Agency
may
determine
that
additional
follow­
up
action
is
necessary
for
either
type
of
submission
and
will
be
providing
necessary
guidance
for
these
requirements.

6(
d)
Bottom
Line
Burden
Hours
and
Cost
Tables
The
following
table
presents
the
total
estimated
annual
burden
and
costs
for
this
ICR:

Table
5
­
Total
Average
Burden
and
Cost
Estimates
Activities
Respondent
Agency
Totals
Burden
(
hrs)
Costs
($)
Burden
(
hrs)
Costs
($)
Burden
(
hrs)
Costs
($)

Initial
Rule
Familiarization
1,067
$
93,866
0
0
1,067
$
93,866
CBI
Substantiations
301
$
27,370
147
$
10,934
448
$
38,304
Adverse
Effects
Reports
2.5
$
202.33
2.33
$
140.00
5
$
342.33
August
27,
2003
Draft
for
Public
Comment
Page
18
of
19
Totals
1,370.5
$
121,438
149.33
$
11,074
1,520
$
132,512
Columns
may
not
add
due
to
rounding.

6(
e)
Reasons
for
Change
in
Burden
Respondent
costs
for
this
ICR
have
increased
due
to
increases
in
labor
rates
for
both
respondents
and
Agency
personnel.
As
a
result,
there
is
an
increase
of
$
1,446
in
the
estimated
total
annual
respondent
cost
(
from
$
119,992
to
$
121,438).
This
change
is
an
adjustment.
These
estimates
are
based
on
the
Agency
anticipation
that
there
may
be
as
many
as
14
plantincorporated
protectant
submissions
in
the
first
few
years,
growing
to
44
submissions
in
year
10,
and
that
there
is
likely
to
be
more
than
one
adverse
effects
reports
for
exempted
plantincorporated
protectants.
Since
the
Agency
does
not
yet
have
any
experience
upon
which
to
base
a
prediction
of
the
number
of
submissions,
the
annual
number
of
events
in
future
ICRs
may
need
to
be
adjusted.

6(
f)
Burden
Statement
The
annual
respondent
burden
for
the
collection
of
information
associated
with
the
substantiation
at
the
time
of
submission
for
CBI
claims
related
to
a
plant­
incorporated
protectant
application
is
estimated
to
average
21.5
hours
per
submission,
and
the
annual
respondent
burden
for
the
collection
of
information
associated
with
the
reporting
of
adverse
effects
for
exempted
plant­
incorporated
protectants
is
estimated
to
average
7.5
hours
per
submission.
The
total
annual
respondent
burden
for
the
collection
of
information
contained
in
this
ICR
is
estimated
to
be
1,370.5
hours.
The
following
is
a
brief
overview
of
the
burden
and
cost
estimates
for
this
ICR:

The
total
estimated
annual
respondent
paperwork
burden
to
comply
with
this
information
collection
activity
is
1,370
hours.
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.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purpose
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.

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
August
27,
2003
Draft
for
Public
Comment
Page
19
of
19
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.

Send
comments
regarding
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
the
burden,
to:
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
2822T),
1200
Pennsylvania
Avenue,
NW,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
requested
information
or
forms
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
in
the
Federal
Register
Notice
seeking
comment
on
this
ICR.
Please
reference
this
document
by
the
OMB
Control
No.
2070­
0142
in
all
correspondence.