Document ID: EPA-HQ-OPP-2004-0111-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-06-01T04:00Z

DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
1
of
55
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a).
Title
of
the
Information
Collection:
Data
Call­
Ins
for
the
Special
Review
and
Registration
Review
Programs
ICR
Numbers:
OMB
Control
No.
2070­
0057;
EPA
ICR
No.
0922.07
1(
b).
Short
Characterization/
Abstract
This
is
a
request
to
renew
the
existing
information
collection
request
(
ICR)
entitled:
Data
Call­
Ins
for
the
Special
Review
and
Registration
Review
Programs
(
OMB
No.
2070­
0057;
EPA
No.
0922.07).
This
information
collection
will
enable
the
Environmental
Protection
Agency
(
EPA)
to
collect
the
necessary
data
to
assess
whether
the
continued
registration
of
an
existing
pesticide
causes
an
unreasonable
adverse
effect
on
human
health
or
the
environment.
The
Special
Review
process
is
set
in
motion
when
EPA
has
reason
to
believe
that
the
use
of
a
pesticide
may
result
in
unreasonable
adverse
effects
to
human
health
or
the
environment.
The
goal
of
this
process
is
to
reduce
the
risks
posed
by
a
pesticide
to
an
acceptable
level
while
taking
into
consideration
the
benefits
provided
by
the
use
of
the
pesticide.
The
Agency
is
authorized
to
use
section
3(
c)(
2)(
B)
of
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)
to
require
pesticide
registrants
to
generate
and
submit
data
to
the
Agency
where
such
data
is
needed
to
assess
whether
registration
of
an
existing
pesticide
poses
unreasonable
risk
to
human
health
or
the
environment.

This
ICR
also
includes
the
information
collection
related
to
the
Registration
Review
Program.
The
Food
Quality
Protection
Act
of
1996
(
FQPA),
which
amended
the
two
primary
statutes
regulating
pesticides,
i.
e.,
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
and
FIFRA,
established
the
Registration
Review
Program.
Under
FIFRA
§
3(
g),
EPA
must
now
periodically
review
all
pesticide
registrations.
The
goal
of
the
regulations
is
Agency
review
of
pesticide
registrations
on
a
15­
year
cycle.
In
doing
so,
the
Agency
is
authorized
to
use
FIFRA
§
3(
c)(
2)(
B)
to
require
pesticide
registrants
to
generate
and
submit
data
to
the
Agency
where
such
data
is
needed
to
assess
whether
registration
of
an
existing
pesticide
poses
unreasonable
risk
to
human
health
or
the
environment.

EPA's
Office
of
Pesticide
Programs
(
OPP),
under
the
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances,
uses
this
ICR
to
obtain
the
data
needed
by
OPP
scientists
to
assess
whether
certain
pesticides
should
continue
to
be
registered.
After
identifying
a
specific
data
need
for
a
particular
chemical,
either
as
part
of
Special
Review
or
as
part
of
Registration
Review,
the
Agency
will
first
search
for
available
information
(
i.
e.,
EPA
databases
for
information
that
may
have
been
submitted
to
EPA
under
another
ICR,
voluntarily,
or
submitted
by
another
respondent;
information
that
has
otherwise
published
in
the
literature;
or
information
that
is
otherwise
publicly
available).
Only
if
the
needed
data
is
not
found
will
EPA
require
the
submission
or
generation
of
the
specific
data
needed.
DRAFT
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April
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2004
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55
The
information
collected
under
this
ICR
may
consist
of
toxicology
studies,
fish
and
wildlife
studies,
environmental
fate
studies,
chemistry
studies
or
other
data
needed
to
analyze
the
potential
risks
and
benefits
associated
with
pesticide
chemicals.

Since
the
information
collection
activities
related
to
the
Registration
Review
Program
are
very
similar
to
those
related
to
the
Special
Review
Program,
EPA
has
continued
to
include
both
programs
in
this
ICR.
Both
collections
derive
their
authority
and
procedures
from
FIFRA
§
3(
c)(
2)(
B)
and
are
part
of
ongoing
processes.
Both
collections
are
based,
in
part,
on
concerns
about
potential
hazard.

Please
note
that
the
information
collection
activities
contained
in
this
ICR
are
separate
from
those
described
in
the
ICR
entitled
"
Data
Generation
for
Reregistration"
[
OMB
Control
#
2070­
0107;
EPA
ICR
#
1504],
which
involves
the
collection
of
information
necessary
to
reregister
pesticides
which
were
registered
before
1984
in
accordance
with
FIFRA
§
4.
The
reregistration
program
is
expected
to
be
completed
by
2006
for
food­
use
pesticide
ingredients
and
2008
for
non­
food
use
pesticide
ingredients.

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a).
Need/
Authority
for
the
Collection
FIFRA
sections
3(
a)
and
12(
a)(
1)
require
a
person
to
register
a
pesticide
product
with
the
EPA
before
the
pesticide
product
may
be
lawfully
sold
or
distributed
in
the
United
States.
A
pesticide
registration
is
a
license
that
allows
a
pesticide
product
to
be
sold
and
distributed
for
specific
uses
under
specified
terms
and
conditions
such
as
use
instructions
and
precautions.
A
pesticide
product
may
be
registered
or
remain
registered
only
if
it
meets
the
statutory
standard
for
registration
given
in
FIFRA
§
3(
c)(
5),
which
is
as
follows:

(
A)
Its
composition
is
such
as
to
warrant
the
proposed
claims
for
it.
(
B)
Its
labeling
and
other
material
required
to
be
submitted
comply
with
the
requirements
of
this
Act.
(
C)
It
will
perform
its
intended
function
without
unreasonable
adverse
effects
on
the
environment.
(
D)
When
used
in
accordance
with
widespread
and
commonly
recognized
practice
it
will
not
generally
cause
unreasonable
adverse
effects
on
the
environment.

FIFRA
§
2(
bb)
defines
"
unreasonable
adverse
effects
on
the
environment''
as
(
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.''

The
proponent
of
initial
or
continued
registration
always
bears
the
burden
of
demonstrating
that
a
pesticide
product
meets
the
statutory
standard
for
registration.
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12,
2004
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The
authority
for
the
information
collection
activities
contained
in
this
ICR
can
be
found
in
FIFRA
§
3(
c)(
2)(
B),
which
allows
EPA
to
require
pesticide
registrants
to
generate
and
submit
data
to
the
Agency
when
data
is
needed
to
assess
whether
the
existing
pesticide
registration
poses
an
unreasonable
risk
to
human
health
or
the
environment.
A
copy
of
this
section
is
provided
in
Attachment
A.

Whenever
EPA
has
reason
to
believe
that
the
use
of
a
registered
pesticide
may
result
in
unreasonable
adverse
effects
to
people
or
the
environment,
the
Agency
initiates
a
Special
Review
of
the
registration
for
that
pesticide
to
determine
whether
it
must
take
any
action
under
FIFRA
§
6(
b)
to
cancel
or
change
the
registration
of
that
pesticide.
Special
Review
is
an
intensive
and
systematic
examination
process
that
offers
opportunities
for
interested
parties
to
comment
and
present
evidence
on
the
risks
and
benefits
of
a
pesticide.
EPA
uses
the
authority
under
FIFRA
§
3(
c)(
2)(
B)
to
request
additional
information
from
the
registrant
that
is
necessary
for
its
review.

FIFRA
§
3(
g)
now
requires
EPA
to
periodically
assess
the
registration
of
each
pesticide
and
assess
all
information/
data
necessary
to
determine
whether
the
intended
use(
s)
of
the
pesticide
presents
unreasonable
adverse
effects
on
human
health
or
the
environment.
Continued
registration
of
some
pesticides
may
require
that
the
Agency
obtain
additional
information
under
FIFRA
§
3(
c)(
2)(
B)
necessary
to
complete
the
Registration
Review.

2(
b).
Practical
Utility/
Users
of
the
Data
OPP
will
use
the
information/
data
obtained
from
registrants
to
assess
whether
unreasonable
adverse
effects
are
associated
with
the
use
of
the
chemical
in
the
pesticide
products.
Agency
scientists
and
analysts
integrate
the
new
data
received
from
registrants
with
the
existing
data
in
EPA's
files.
The
information
is
then
reviewed
to
assess
the
potential
risks
and
benefits
associated
with
the
use
of
the
pesticide.
If
it
is
determined
that
regulatory
actions
are
needed,
the
Agency
will
act
accordingly.

A
record
of
each
study
submitted
is
maintained
in
the
Agency's
Pesticide
Document
Management
System
(
PDMS),
and
public
access
to
the
PDMS
bibliography
may
be
made
through
the
National
Pesticides
Information
Retrieval
System
(
NPIRS).
NPIRS
supports
searches
of
the
PDMS
database
by
chemical,
subject,
submission
date,
laboratory,
guideline
number,
and
document
type.
The
public
may
request
copies
of
non­
confidential
studies
through
the
Freedom
of
Information
Act
(
FOIA).

3.
NON­
DUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a).
Non
duplication
The
information
collected
under
this
program
is
collected
by
no
other
federal
agency
or
any
other
office
within
EPA.
As
described
above,
this
information
is
required
for
EPA's
evaluation
of
the
health
and
environmental
effects
and
economic
benefits
associated
with
the
use
of
pesticides.
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2004
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In
addition,
prior
to
requesting
any
information
under
these
programs,
the
Agency
must
review
existing
records
for
the
availability
of
the
information
that
it
is
considering
requesting.
EPA
also
provides
for
public
comment
and
may
modify
its
DCI
requirements
if
warranted
by
information
provided
by
registrants
or
the
public.
Registrants
may
respond
to
the
DCI
by
requesting
waivers
of
data
requirements
if
they
believe
that
OPP
can
properly
evaluate
their
pesticide
without
additional
data.

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

3(
c).
Consultations
Before
a
particular
DCI
is
issued
under
either
program,
the
procedures
for
both
programs
provide
several
opportunities
for
consultations
with
the
affected
registrants,
as
well
as
with
the
public
and
other
interested
parties.

In
the
initial
stage
of
a
Special
Review,
EPA
announces
its
intent
to
conduct
such
a
review
and
require
additional
studies.
Registrants
and
other
interested
parties
have
the
opportunity
to
comment
on
the
Agency's
intent.
Generally,
the
Agency
consults
with
registrants
before
a
data
call­
in
notice
is
issued
to
discuss
the
Agency's
need
for
particular
information
and
the
protocol
to
be
used
to
conduct
the
study.
EPA
is
always
open
to
communications
with
registrants
concerning
any
issue
they
may
have
with
the
requirements
for
data.
As
mentioned,
registrants
may
request
waivers
of
data
requirements
if
they
believe
that
the
Agency
can
properly
evaluate
their
pesticide
without
additional
data.

For
Registration
Review,
EPA
will
document
the
reasons
for
requiring
additional
studies
in
a
Pre­
DCI
Analysis.
EPA
will
announce
the
availability
of
this
document
in
a
FR
notice
and
may
also
hold
a
public
meeting
to
discuss
the
findings
of
the
Pre­
DCI
analysis.
Registrants
and
other
interested
parties
may
submit
additional
information
or
comments
at
this
time.
The
Agency
may
modify
its
DCI
requirements
if
warranted
by
information
provided
by
registrants
or
the
public.
Also,
registrants
may
respond
to
the
DCI
by
requesting
waivers
of
data
requirements
if
they
believe
that
OPP
can
properly
evaluate
their
pesticide
without
additional
data.
As
indicated
previously,
EPA
published
an
advanced
notice
of
proposed
rulemaking
in
2000,
will
propose
rulemaking
in
2005
and
take
public
comment
on
the
establishment
of
procedural
regulations
for
conducting
registration
reviews,
and
complete
final
rulemaking
in
2006.
In
the
meantime,
EPA
will
follow
this
basic
public
process
for
any
necessary
registration
reviews.

In
preparing
the
previous
ICR,
the
Agency
discussed
with
industry
stakeholders
the
incorporation
of
the
burden
related
to
the
new
Registration
Review
program,
along
with
the
methodology
used
to
estimate
the
burden
and
costs.

In
addition,
EPA
will
consult
with
registrants
on
the
information
collection
during
the
renewal
process.
Discussion
with
respondents
will
include
whether
the
labor
rate
estimates
in
the
DRAFT
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April
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2004
Page
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55
ICR
are
accurate
and
whether
the
estimates
of
burden
and
methodology
for
arriving
at
the
estimate
are
correct,
and
alternatives
to
paper­
based
submissions,
i.
e.,
whether
respondents
would
consider
submitting
the
information
electronically,
such
as
through
web
forms
and
the
Agency's
Internet
site
or
submitting
data
on
disk
with
electronic
signatures,
if
that
option
were
available.

3(
d).
Effects
of
Less
Frequent
Collection
Information
is
collected
under
this
ICR
only
when
the
Agency
has
identified
a
need
for
the
specific
data,
and
only
on
a
one­
time
basis.

3(
e).
General
Guidelines
The
only
guideline
established
under
the
Paperwork
Reduction
Act
(
PRA)
that
is
exceeded
in
this
collection
is
the
time
period
for
retaining
records.
Pursuant
to
FIFRA
§
8,
EPA
recordkeeping
requirements
in
40
CFR
169.2(
k)
state
that
records
containing
research
data
relating
to
registered
pesticides
be
retained
as
long
as
the
registration
is
valid
and
the
producer
remains
in
business.
Registrations
are
valid
until
they
are
either
voluntarily
canceled
or
withdrawn
by
the
registrant
or
until
EPA
has
cause
to
suspend
or
cancel
the
registration.
Since
the
average
period
of
marketability
of
a
pesticide
ranges
from
15
to
30
years,
the
PRA
guidelines
specifying
that
data
other
than
health,
medical
or
tax
records
not
be
required
to
be
retained
for
more
than
three
years
will
be
exceeded
in
this
collection
activity.

The
forms
associated
with
this
ICR
are
also
used
for
other
information
collection
activities
that
are
approved
under
separate
OMB
Control
numbers,
e.
g.,
2070­
0107,
2070­
0060,
and
2070­
0122.
The
Agency
recently
completed
a
review
of
these
forms,
which
included
stakeholder
input,
and
has
determined
that
the
elements
on
these
forms
are
not
expected
to
change
when
the
Agency
makes
them
available
electronically.
In
accordance
with
OMB's
guidance
regarding
the
inclusion
of
the
expiration
date
on
forms,
EPA
requests
permission
to
omit
the
current
expiration
date
on
future
forms.

3(
f).
Confidentiality
Most
health
and
safety
data
submitted
by
registrants
under
FIFRA
is
considered
by
OPP
to
contain
no
confidential
business
information
(
CBI).
If,
however,
registrants
submit
data
that
relates
to
trade
secrets
or
commercial
or
financial
information,
such
information
is
protected
from
disclosure
under
section
10
of
FIFRA.
Such
data
submitted
to
this
Agency
are
handled
strictly
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
Security
Manual.
This
manual
contains
instructions
relative
to
all
contact
with
confidential
documents,
including:
responsibilities
of
EPA
employees;
physical
security
measures;
CBI
copying
and
destruction
procedures;
transfer
of
CBI
materials
within
EPA
to
contractors
or
other
government
offices;
computer
security;
CBI
typing
procedures;
and
procedures
internal
to
OPP.
The
manual
dictates
that
all
CBI
must
be
marked
or
flagged
as
such,
all
CBI
intended
to
be
destroyed
must
be
cleared
by
a
document
control
officer
and
shredded.

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

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a).
Respondents/
NAICS
Codes
Respondents
to
the
information
collection
activities
related
to
the
Special
Review
and
the
Registration
Review
Program
consist
of
pesticide
Registrants
identified
by
the
North
American
Industrial
Classification
System
(
NAICS)
code
325320
(
Pesticide
and
Other
Agricultural
Chemical
Manufacturing).

4(
b).
Information
Requested
(
i)
Data
Items,
Including
Record
Keeping
Requirements
Considering
the
potential
variation
in
the
specific
need
identified
for
the
individual
pesticide
under
review,
the
specific
data
items
that
may
be
collected
for
the
individual
pesticides
under
this
ICR
are
also
likely
to
vary
from
pesticide
to
pesticide.
However,
based
on
the
specific
need
identified
for
the
pesticide,
the
Agency
may
request
one
or
more
of
the
following
of
types
of
data:

Product
Chemistry
Residue
Chemistry
Environmental
Fate
Toxicology
Reentry
Protection
Spray
Drift
Wildlife
and
Aquatic
Organisms
Plant
Protection
Nontarget
Insect
Product
Performance
Biochemical
Pesticides
Microbial
Pesticides
These
categories,
which
are
defined
in
greater
detail
in
40
CFR
Part
158,
basically
consist
of
that
information
and/
or
data
that
is
necessary
to
determine
whether
the
intended
use(
s)
of
the
pesticide
presents
unreasonable
adverse
effects
on
human
health
or
the
environment.
In
addition
to
the
categories
identified
above,
the
Agency
may
also
require
that
a
special
study
be
conducted
to
provide
critical
information
about
the
risks
and
benefits
of
the
pesticide
in
support
of
its
continued
registration.
These
special
studies
would
be
based
on
the
particular
characteristics
of
the
chemical,
and
the
Agency's
need
for
such
information
to
make
the
required
statutory
finding.

OPP
will
issue
a
data
call­
in
(
DCI)
for
a
pesticide
chemical
only
after
it
reviews
the
available
data
and
determines
that
the
information
is
not
sufficient
to
satisfy
the
statutory
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requirements
for
continued
registration.
Even
after
OPP
has
completed
its
review
and
has
determined
that
additional
data
must
be
called­
in,
registrants
are
given
the
opportunity
to
request
a
waiver
if
they
believe
that
OPP
can
properly
evaluate
the
risks
of
their
pesticide
chemicals
without
additional
data.
OPP
will
review
each
waiver
request
individually.

The
following
forms
are
associated
with
this
ICR,
but
may
also
be
used
and
referenced
under
other
information
collection
activities
and
the
related
ICRs
involving
DCIs:

1)
Data
Call­
in
Response
Form
(
See
Attachment
B)

2)
Requirements
Status
and
Registrant's
Response
Form
(
See
Attachment
C)

3)
EPA
Form
8570­
32:
Certification
of
Attempt
to
Enter
into
an
Agreement
with
Registrants
for
Development
of
Data
(
See
Attachment
D)

4)
EPA
Form
8570­
34:
Certification
with
Respect
to
Citation
of
Data
(
See
Attachment
E)

Although
the
Registration
Review
program
is
new,
FIFRA
section
3(
g)
also
instructs
the
Agency
to
rely
on
existing
authorities
for
data
submission,
data
compensation,
data
exemption,
or
cancellation
of
registrations.
Therefore,
the
procedures
for
acquiring
new
information
or
granting
data
exemptions
under
the
Registration
Review
program
already
exist,
and
there
are
no
additions,
deletions
or
changes
to
the
universe
of
potential
data
items
collected
since
the
last
OMB
clearance.
The
same
type
of
data
items
may
be
collected
under
the
Special
Review
and
the
Registration
Review
Programs.
However,
since
the
collection
activities
under
both
programs
are
limited
to
specific
pesticides
and
specifically
identified
needs
for
those
pesticides,
the
collection
activities
under
both
programs
will
not
be
duplicative.

(
ii)
Respondent
Activities
A
pesticide
registrant
whose
chemicals
are
under
Special
Review
or
Registration
Review
will
engage
in
the
following
activities
under
this
ICR.

read
instructions
read
the
DCI
letter
to
understand
what
data
are
to
be
submitted
plan
activities
plan
the
activities
necessary
to
comply
with
the
DCI,
or
develop
options
to
avoid
having
to
submit
data
(
e.
g.,
exemption/
waiver)

create
information
conduct
research,
administer
tests,
analyze
data
to
develop
studies,
perform
laboratory
analysis,
write
study
documents
gather
information
search
for
existing
data
that
will
satisfy
the
DCI
compile
and
review
assemble
and
evaluate
data
for
accuracy
and
appropriateness
for
compliance
with
the
DCI
complete
paperwork
prepare
necessary
correspondence,
documents
and
packages
for
submitting
data
to
EPA
maintain
and
file
maintain
the
data
and
other
information
submitted
to
the
Agency
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Registrants
who
receive
a
data
call­
in
notice
from
EPA
must
notify
the
Agency
how
they
intend
to
comply
with
the
terms
of
the
DCI
notice
within
90
days
of
receipt
of
the
notice.
The
options
for
complying
are
to
voluntarily
cancel
their
product(
s),
delete
certain
uses,
claim
a
generic
data
exemption,
agree
to
satisfy
the
data
requirements
imposed
by
the
notice,
or
request
a
data
waiver.

Voluntary
Cancellation
­
Registrants
opting
to
voluntarily
cancel
their
products
containing
the
active
ingredient
that
is
subject
to
the
DCI
must
submit
a
completed
Data
Call­
In
Response
Form.
If
a
product
is
voluntarily
cancelled,
further
sale
and
distribution
of
that
product
after
the
effective
date
of
cancellation
must
be
in
accordance
with
the
existing
stocks
provision
of
the
individual
DCI
notice.

Deletion
of
Uses
­
Registrants
choosing
to
amend
their
registration
to
delete
the
uses
of
their
product
to
which
the
requirements
apply
must
submit
the
Requirements
Status
and
Registrant's
Response
Form,
a
completed
application
for
amendment,
a
copy
of
their
proposed
amended
labeling,
and
all
other
information
required
for
processing
the
application.
They
must
also
complete
a
Data
Call­
In
Response
Form.
If
registrants
choose
to
delete
the
use(
s)
subject
to
the
DCI
notice
or
uses
subject
to
specific
data
requirements,
further
sale,
distribution,
or
use
of
their
product
after
one
year
from
the
due
date
of
their
90­
day
response
must
bear
an
amended
label.

Generic
Data
Exemption
­
Registrants
are
entitled
to
apply
for
a
generic
data
exemption
from
the
requirement
to
submit
or
cite
generic
data
concerning
an
active
ingredient
if
the
active
ingredient
in
the
product
is
derived
exclusively
from
purchased,
registered
pesticide
products
containing
the
active
ingredient.
To
qualify
for
a
generic
data
exemption,
a
product
must
meet
all
of
the
following
requirements:

a.
The
active
ingredient(
s)
in
the
registered
product
must
be
present
solely
because
of
incorporation
of
another
registered
product
which
contains
the
subject
active
ingredient(
s)
and
be
purchased
from
a
source
not
connected
with
the
registrant;
and,

b.
Every
registrant
who
is
the
ultimate
source
of
the
active
ingredient(
s)
in
the
product
subject
to
the
DCI
notice
must
be
in
compliance
with
the
requirements
of
the
notice
and
must
remain
in
compliance;
and
c.
The
registrant
of
the
product
that
is
the
subject
of
the
DCI
notice
must
have
provided
to
EPA
an
accurate
and
current
"
Confidential
Statement
of
Formula"
for
each
of
the
products
to
which
the
Notice
applies.

Registrants
applying
for
the
Generic
Data
Exemption
must
submit
a
completed
Data
Call­
In
Response
Form
and
all
supporting
documentation.
If
a
generic
data
exemption
is
claimed,
the
registrant
is
not
required
to
complete
the
Requirements
Status
and
Registrant's
Response
Form.
Generic
data
exemption
cannot
be
selected
as
an
option
for
product
specific
data.

Registrants
who
are
granted
a
Generic
Data
Exemption
rely
on
the
efforts
of
other
persons
to
provide
the
Agency
with
the
required
data.
If
the
registrant(
s)
who
have
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committed
to
generate
and
submit
the
required
data
fail
to
take
appropriate
steps
to
meet
the
requirements
or
are
no
longer
in
compliance
with
the
DCI
notice,
the
Agency
will
consider
that
both
registrants
are
not
in
compliance
and
will
normally
initiate
proceedings
to
suspend
the
registrations
of
both
registrants'
products
unless
the
registrant
who
was
granted
the
generic
data
exemption
commits
to
submit
and
does
submit
the
required
data
within
the
specified
time.
In
such
cases
the
Agency
generally
will
not
grant
a
time
extension
for
submitting
the
data.

Submission
of
Data
Required
by
the
Notice
­
Registrants
choosing
this
option
must
agree
to
either:
submit
the
data
required
by
the
notice
within
the
specified
time
frame;
enter
into
an
agreement
with
one
or
more
other
registrants
to
develop
data
jointly;
make
offers
to
cost­
share;
submit
an
existing
study
that
has
not
been
submitted
previously
to
the
Agency
by
anyone;
submit
or
cite
data
to
upgrade
a
study
classified
by
EPA
as
partially
acceptable
and
upgradeable;
or
cite
an
existing
study
that
EPA
has
classified
as
acceptable
or
an
existing
study
that
has
been
submitted
but
not
reviewed
by
the
Agency.

Submission
of
Data
Waiver
Request
­
A
registrant
may
request
either
a
low
volume/
minor
use
waiver
or
a
waiver
based
on
the
registrant's
belief
that
the
data
requirement(
s)
do
not
apply
to
their
product.
In
addition
to
the
Requirements
Status
and
Registrant's
Response
Form,
registrants
requesting
low
volume/
minor
use
waivers
must
submit
the
following
information:

a.
Total
company
sales
(
pounds
and
dollars)
of
all
registered
product(
s)
containing
the
active
ingredient(
s).
If
applicable
to
the
active
ingredient(
s),
include
foreign
sales
for
those
products
that
are
not
registered
in
this
country
but
are
applied
to
sugar
(
cane
or
beet),
coffee,
bananas,
cocoa,
and
other
such
crops,
by
year
for
each
of
the
past
five
years.

b.
An
estimate
of
the
sales
(
pounds
and
dollars)
of
the
active
ingredient(
s)
for
each
major
use
site,
by
year
for
each
of
the
past
five
years.

c.
Total
direct
production
cost
of
product(
s)
containing
the
active
ingredient(
s)
by
year
for
the
past
five
years,
including
information
on
raw
material
cost,
direct
labor
cost,
advertising,
sales
and
marketing,
and
any
other
significant
costs,
listed
separately.

d.
Total
indirect
production
cost
(
e.
g.
plant
overhead,
amortized
plant
and
equipment)
charged
to
product(
s)
containing
the
active
ingredient(
s)
by
year
for
the
past
five
years.
Exclude
all
non­
recurring
costs
that
were
directly
related
to
the
active
ingredient(
s),
such
as
costs
of
initial
registration
and
any
data
development.

e.
A
list
of
each
data
requirement
for
which
the
registrant
is
requesting
a
waiver.

f.
The
type
of
waiver
sought
and
the
estimated
cost
to
you
(
listed
separately
for
each
data
requirement
and
associated
test)
of
conducting
the
testing
needed
to
fulfill
each
of
these
data
requirements.
g.
A
list
of
each
data
requirement
for
which
the
registrant
is
not
seeking
any
waiver
and
the
estimated
cost
(
listed
separately
for
each
data
requirement
and
associated
test)
of
conducting
the
testing
needed
to
fulfill
each
of
these
data
requirements.
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h.
For
each
of
the
next
ten
years,
a
year­
by­
year
forecast
of
company
sales
(
pounds
and
dollars)
of
the
active
ingredient(
s),
direct
production
costs
of
product(
s)
containing
the
active
ingredient(
s)
(
following
the
parameters
in
item
c
above),
indirect
production
costs
of
product(
s)
containing
the
active
ingredient(
s)
(
following
the
parameters
in
item
d
above),
and
costs
of
data
development
pertaining
to
the
active
ingredient(
s).
In
addition,
the
registrant
must
provide
a
description
of
the
importance
and
unique
benefits
of
the
active
ingredient(
s)
to
users
and
discuss
the
use
patterns
and
the
effectiveness
of
the
active
ingredient(
s)
relative
to
registered
alternative
chemicals
and
non­
chemical
control
strategies.
Focus
on
benefits
unique
to
the
active
ingredient(
s),
providing
information
that
is
as
quantitative
as
possible.
If
quantitative
data
is
not
available
upon
which
to
base
estimates,
then
present
the
reasoning
used
to
derive
estimates.
To
assist
the
Agency
in
determining
the
degree
of
importance
of
the
active
ingredient(
s)
in
terms
of
its
benefits,
information
should
be
provided
on
any
of
the
following
factors,
as
applicable
to
your
product(
s):

°
documentation
of
the
usefulness
of
the
active
ingredient(
s)
in
Integrated
Pest
Management
°
description
of
the
beneficial
impacts
on
the
environment
of
use
of
the
active
ingredient(
s),
as
opposed
to
its
registered
alternatives
°
information
on
the
breakdown
of
the
active
ingredient(
s)
after
use
and
on
its
persistence
in
the
environment,
and
°
description
of
the
product's
usefulness
against
pest(
s)
of
public
health
significance.

Failure
to
submit
sufficient
information
for
the
Agency
to
make
a
determination
regarding
a
request
for
a
low
volume
minor
use
waiver
will
result
in
denial
of
the
request
for
a
waiver.

Request
for
Waiver
of
Data
­
A
registrant
may
also
request
a
waiver
if
they
believe
that
a
particular
data
requirement
should
not
apply
because
the
corresponding
use
is
no
longer
registered
or
the
requirement
is
inappropriate.
In
addition
to
the
Requirements
Status
and
Registrant's
Response
Form,
registrants
requesting
a
waiver
of
data
requirements
must
submit
a
rationale
explaining
why
the
registrant
believes
the
data
requirements
should
not
apply,
as
well
as
copies
of
current
product
labels
and
a
current
copy
of
the
Confidential
Statement
of
Formula
for
each
product.
If
the
Agency
determines
that
a
registrant
does
not
qualify
for
a
waiver
and
that
the
data
are
required
for
the
product(
s),
the
registrant
must
choose
a
method
of
meeting
the
requirements
of
the
notice
within
the
90­
day
time
frame
provided
by
the
notice.
Within
30
days
of
the
registrant's
receipt
of
the
Agency's
written
decision,
the
registrant
must
submit
a
revised
Requirements
Status
and
Registrant's
Response
Form
indicating
the
option
chosen.

5.
THE
INFORMATION
COLLECTED
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a).
Agency
Activities
The
following
Agency
activities
are
necessary
to
conduct
a
DCI
under
this
ICR:

develop
DCI
correspondence
prepare
the
DCI
letter
identifying
all
the
data
needed
answer
registrants'
questions
respond
to
any
questions
the
registrant
may
have
regarding
the
DCI
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review
data
submissions
review
data
submissions
for
completeness
and
appropriateness
record
DCI
submissions
record
submissions
in
tracking
system
for
internal
review
analyze
data
conduct
scientific
reviews
of
data
store
data
index
data
and
store
it
in
Agency
files
5(
b).
Collection
Methodology
and
Management
When
the
need
for
additional
information/
data
for
a
particular
pesticide
is
identified
under
Special
Review
or
in
the
Registration
Review
process,
OPP
will
issue
a
data
call­
in
(
DCI)
to
obtain
the
necessary
data
from
the
Registrant(
s)
of
that
pesticide.

A
pesticide
will
undergo
Special
Review
when
the
Agency
has
reason
to
believe
that
the
use
of
the
pesticide
may
result
in
unreasonable
adverse
effects
to
people
or
the
environment.
In
accordance
with
FIFRA
§
3(
g)(
1)(
A),
a
pesticide
must
undergo
Registration
Review
every
15
years.
As
a
result,
the
initiation
of
Special
Review
is
triggered
by
the
availability
of
information
to
EPA
which
calls
into
question
the
existing
registration
of
a
particular
pesticide,
while
the
initiation
of
Registration
Review
is
triggered
by
the
date
of
the
original
registration
(
i.
e.,
prior
to
1984).

When
a
Special
Review
is
initiated,
the
Agency
notifies
the
registrant(
s)
for
the
pesticide
in
question,
and,
after
reviewing
the
available
information
to
identify
the
data
that
is
missing
but
necessary
for
evaluating
the
continued
registration
of
the
pesticide
in
question,
the
Agency
publishes
a
document
that
presents
its
review
and
findings.
Comments
from
the
registrant,
public
and
other
interested
parties
are
considered,
and
a
DCI
is
issued
to
gather
any
missing
but
necessary
data.
After
considering
the
data
submitted
in
response
to
the
DCI,
the
Agency
issues
a
Special
Review
Decision
Document
which
describes
the
Agency's
review,
findings,
and
decisions
regarding
the
registration
of
the
pesticide
in
question,
which
are
then
implemented
with
appropriate
registration
actions.

The
method
for
scheduling
the
registration
review
of
pesticides
will
be
established
in
the
procedural
regulations
that
are
currently
still
under
development
with
broad
participation
from
the
regulated
community
and
other
stakeholders.
In
general,
the
scheduling
of
the
registration
reviews
for
the
individual
chemicals
will
be
based
on
the
goal
of
a
15­
year
review
pursuant
to
FIFRA
§
3(
g).
On
April
26,
2000,
EPA
issued
an
advance
notice
of
proposed
rulemaking
that
sought
initial
public
comment
of
the
basic
procedural
framework
that
the
Agency
is
considering
for
carrying
out
the
mandated
registration
reviews
(
65
FR
24586)
(
see
Attachment
F).
While
in
that
document,
the
Agency
stated
an
intent
for
registration
review
to
be
implemented
in
2005,
the
procedural
final
rulemaking
to
implement
the
program
will
not
be
completed
until
2006.
In
the
meantime,
the
Agency
will
only
issue
DCIs
for
specific
information
that
is
necessary
to
meet
new
statutory
requirements
(
e.
g.,
FFDCA
§
408(
p)
requires
EPA
to
screen
all
pesticides
for
estrogenic
activity).

The
effective
and
efficient
management
of
the
Information
collected
pursuant
to
this
ICR
is
a
critical
component
of
these
programs.
As
indicated
in
section
2(
b)
of
this
ICR,
a
record
of
each
study
submitted
in
response
to
a
DCI
issued
under
this
ICR
is
maintained
in
the
Agency's
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
12
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55
PDMS.
This
information
may
then
be
easily
accessed
by
EPA
personnel
involved
in
reviewing
the
data
as
part
of
a
Special
Review
or
Registration
Review.
In
addition,
this
information
may
be
subsequently
accessed
by
EPA
personnel
whenever
necessary
as
part
of
any
other
Agency
activities
that
require
the
pesticide­
specific
information
in
question,
i.
e.,
the
information
submitted
to
EPA
becomes
part
of
the
Agency's
"
available
information"
that
is
first
consulted
whenever
necessary
to
make
decisions
under
FIFRA
or
FFDCA.

OPP
continues
to
revise
its
information
tracking
systems
to
improve
efficiency
and
accuracy.
The
Office
of
Pesticide
Programs
Information
System
has
improved
the
quality
of
the
Agency's
databases
and
will
allow
the
EPA
to
respond
more
timely
and
accurately
to
queries,
including
requests
made
under
FOIA.

OPP
is
investigating
the
possibility
of
providing
optional
electronic
data
transfer
services
to
the
industry
as
a
means
of
minimizing
the
burden
of
registration
activities.
The
Agency's
pesticide
program,
along
with
the
pesticide
industry,
recognizes
the
advantages
in
terms
of
accuracy,
speed,
cost
and
personnel
from
electronic
data
transfer
technologies.
In
addition,
OPP
is
consulting
with
industry
associations
and
other
federal
agencies,
and
participating
in
an
Agencywide
workgroup
to
develop
electronic
reporting
standards
intended
to
facilitate
the
submission
and
use
of
information
about
pesticides.

Although
the
Agency
does
not
publish
the
submitted
information,
and
public
access
to
the
PDMS
bibliography
is
made
through
the
National
Pesticides
Information
Retrieval
System
(
NPIRS).
NPIRS
supports
searches
of
the
PDMS
database
by
chemical,
subject,
submission
date,
laboratory,
guideline
number,
and
document
type.
The
public
may
request
copies
of
nonconfidential
studies
through
FOIA.

5(
c).
Small
Entity
Flexibility
Small
businesses
are
generally
exempt
from
the
generation
of
data
on
purchased
active
ingredients.
Most
small
entities
are
formulators
and
not
basic
manufacturers.
Thus,
they
do
not
have
the
responsibility
for
supplying
basic
data
on
a
chemical
unless
the
manufacturer
decides
not
to
support
the
registration.
Formulators
need
only
respond
to
a
data
call­
in
for
basic
data
by
indicating
a
legitimate
claim
for
exemption.
They
do
not
incur
any
other
information
burden
associated
with
the
call­
in.

5(
d).
Collection
Schedule
There
is
not
a
collection
schedule
per
se.
DCIs
are
issued
when
the
need
is
identified.
The
time
frame
in
which
the
respondents
must
then
submit
the
requested
material
is
specifically
established
for
each
DCI
based
on
the
individual
circumstances
surrounding
the
particular
DCI
and
applicable
review.
EPA
usually
works
with
respondents
to
ensure
that
sufficient
time
is
built
into
the
individual
DCIs
to
allow
for
respondents
to
gather
and
submit
the
requested
information.

6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
13
of
55
To
estimate
the
burden
and
costs
for
the
paperwork
related
activities
for
the
respondents
to
comply
with
DCIs
that
could
be
issued
under
this
ICR,
EPA
used
the
same
methodology
as
was
previously
used
to
estimate
DCI
related
paperwork
burden.
A
general
description
of
this
methodology
is
provided
in
Attachment
G.
In
short,
this
methodology
used
the
total
cost
of
the
test
required
by
the
DCI
to
generate
estimates
for
the
burden
and
cost
of
the
paperwork
related
activities
associated
with
DCIs.

The
following
estimates
represent
the
potential
burden
and
costs
related
to
the
creation/
gathering,
submission,
and
recordkeeping
of
the
data
requested
pursuant
to
a
DCI
issued
under
this
ICR.
The
Agency
has
estimated
the
annual
and
total
potential
burden
and
costs
during
the
three­
year
approval
period.

The
annual
respondent
burden
hour
and
cost
estimate
for
this
ICR
(
both
the
Special
Review
and
Registration
Review
programs)
is
estimated
to
be
64,699
hours,
with
a
cost
of
$
5,851,894.
Therefore,
the
total
respondent
burden
hour
and
cost
estimate
for
this
ICR
over
three
years
is
estimated
to
be
194,097
hours,
with
a
cost
of
$
17,555,682.

Respondent
costs
are
based
on
managerial,
technical
and
clerical
burden
hours
estimated
at
$
130,
$
88,
and
$
40
per
hour,
respectively.
EPA
has
calculated
the
estimated
labor
rates
for
respondents
to
the
requirements
of
this
ICR
factoring
in
an
inflation
cost
index
of
1.056
based
on
the
Gross
Domestic
Product.
These
labor
rates
are
fully
loaded
and
include
benefits
and
overhead
costs.

The
following
includes
a
breakdown
of
the
annual
and
total
potential
burden
hours
and
costs
by
respondent
and
by
the
annual
and
total
number
of
responses.

6(
a).
Estimating
Respondent
Burden
As
illustrated
in
Table
1A,
the
average
annual
burden
for
Special
Review
is
estimated
to
be
919
hours
per
response
with
one
annual
response
expected,
for
a
total
annual
burden
of
919
hours.
In
this
ICR,
the
average
number
of
burden
hours
per
response
for
Special
Review
is
the
same
as
in
the
previous
ICR;
i.
e.,
919
hours.
This
annual
burden
estimate
is
based
on
the
following
assumptions:
(
a)
that
the
Agency
would
issue
1
DCI
under
the
Special
Review
program
(
aka
Special
Review
DCIs)
in
any
given
12­
month
period,
and
(
b)
that
for
each
Special
Review
DCI
issued,
there
would
be
1
response.
Over
a
three­
year
ICR
approval
period,
three
responses
would
be
expected
and
the
total
respondent
burden
for
Special
Review
related
activities
is
estimated
to
be
2,757
hours.

The
potential
number
of
Special
Review
DCIs
required,
the
type
of
data,
and
the
number
of
respondents
affected
are
quite
variable.
The
burden
estimates
for
the
Special
Review
DCIs
for
this
ICR
renewal
were
calculated
using
information
from
Special
Review
DCIs
conducted
during
the
previous
approval
period.
Review
of
this
information
resulted
in
the
Agency's
estimates
that
1
Special
Review
DCIs
would
be
required
per
year
affecting
approximately
1
respondent
per
DCI
for
a
total
of
3
responses.
Because
of
the
variability
inherent
in
each
Special
Review
DCI,
the
estimates
serve
as
a
proxy
for
what
the
actual
burdens
are
likely
to
be.
Although
the
Agency
estimated
that
an
average
of
1
respondent
per
Special
Review
DCI
is
expected
because
the
DRAFT
FOR
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COMMENT
April
12,
2004
Page
14
of
55
majority
of
the
Special
Review
DCIs
have
only
affected
1
or
2
respondents,
some
previous
Special
Review
DCIs
have,
on
occasion,
exceeded
this.

In
the
Special
Review
Program,
EPA
focuses
on
specific
hazards
or
uses
of
a
pesticide.
Special
Reviews
are
not
intended
to
be
comprehensive
evaluations
of
the
pesticide;
DCIs
address
specific
hazard
or
exposure
concerns
that
are
at
issue.
The
Agency
believes
that
it
has
sufficient
experience
with
administering
DCIs
to
make
reasonable
estimates
of
the
information
burden
that
will
be
generated.

Special
Review
DCI's,
like
Registration
Review
DCI's,
may
request
data
on
more
than
one
pesticide,
and
may
involve
two
or
more
respondents
who
join
together
to
provide
the
needed
data.

It
is
important
to
note
that
this
analysis
assumes
one
registrant
will
generate
the
test
data
for
a
given
chemical;
if
a
consortium
takes
responsibility
for
the
data,
the
burden
and
cost
will
be
distributed
across
members
of
the
consortium
so
the
per­
respondent
burden
would
be
less.
In
addition,
in
recent
years,
the
Agency
has
not
typically
issued
1
Special
Review
DCI
each
year
over
a
three­
year
period.

Table
1A:
Average
Annual
Burden/
Cost
Estimates
for
Special
Review
DCIs
per
Respondent
BURDEN
HOURS
(
per
year)
TOTALS
COLLECTION
ACTIVITIES
Mgmt.
$
130/
hr
Tech.
$
88/
hr
Cler.
$
40/
hr
Hrs
Cost
1)
Read
and
discuss
test
requirements
18
0
0
18
$
2,340
2)
Discuss
test
and
protocol
with
Agency
9
9
0
18
$
1,962
3)
Plan
activities
0
0
0
0
$
0
4)
Create
information
37
9
0
46
$
5,602
5)
Gather
information
28
460
0
488
$
44,120
6)
Process,
compile,
review
information
for
accuracy
0
46
0
46
$
4,048
7)
Complete
written
forms
55
74
55
184
$
15,862
8)
Record,
disclose,
display
information
0
0
18
18
$
720
9)
Store,
file,
or
maintain
information
36
0
65
166
$
7,280
TOTAL
183
(
20%)
598
(
65%)
138
(
15%)
919
$
81,934
Special
Review
Total
Respondent
Burden
and
Cost
Per
Year
During
Three
Year
Period:
Hours:
1
response
X
919
=
919
hours
Costs:
1
response
X
$
81,934
=
$
81,934
Special
Review
Total
Respondent
Burden
and
Cost
Over
Three
Years:
Hours:
3
responses
X
919
=
2,757
hours
Costs:
3
responses
X
$
81,934
=
$
245,802
DRAFT
FOR
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COMMENT
April
12,
2004
Page
15
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55
As
illustrated
in
Table
1B,
the
average
annual
burden
for
Registration
Review
is
estimated
to
be
1,063
hours
per
response
with
60
responses
expected
annually,
for
a
total
annual
burden
of
63,780
hours
(
1,063
x
60).
In
this
ICR,
the
average
number
of
burden
hours
per
response
for
Registration
Review
is
the
same
as
in
the
previous
ICR;
i.
e.,
1,063
hours.
This
annual
burden
estimate
is
based
on
the
following
two
assumptions:
(
a)
that
the
Agency
would
issue
at
least
40
DCIs
under
the
Registration
Review
program
(
aka
Registration
Review
DCIs)
in
any
given
12­
month
period,
and
(
b)
that
for
each
Registration
Review
DCI
issued,
there
would
be
at
least
1.5
responses
on
average
per
DCI.
Over
a
three­
year
ICR
approval
period,
180
responses
would
be
expected
and
the
total
respondent
burden
for
Registration
Review
related
activities
is
estimated
to
be
191,340
hours.

In
the
Reregistration
Program,
EPA
examined
the
entire
data
base
supporting
all
uses
of
the
pesticide.
Pesticides
on
Reregistration
"
List
A"
had
been
reviewed
in
the
1980'
s
and
generally
had
more
complete
data
bases
than
other
pesticides
in
the
Reregistration
Program.

In
the
Registration
Review
Program,
EPA
will,
among
other
things,
update
the
databases
of
pesticides
to
obtain
data
that
were
not
required
when
the
pesticide
was
registered
or
reregistered,
but
which
are
now
required
and
determined
necessary.
The
Agency
believes
that
it
has
sufficient
experience
with
administering
DCIs
to
make
reasonable
estimates
of
the
information
burden
that
will
be
generated
by
Registration
Review
DCIs.

The
potential
number
of
Registration
Review
DCIs
that
will
be
issued,
the
type
of
data,
and
the
number
of
respondents
affected
will
be
quite
variable.
As
indicated
in
the
advance
notice
related
to
the
procedural
regulations
that
are
under
development,
EPA
is
considering
providing
an
advance
notice
in
scheduling
the
registration
reviews.
Once
the
procedural
rule
is
issued,
the
schedule
of
registration
reviews
will
enable
the
Agency
to
provide
a
better
estimate
of
the
potential
number
of
Registration
Review
DCIs
in
any
given
12­
month
period,
along
with
the
related
burden.

In
the
meantime,
since
the
Registration
Review
DCIs
expected
during
the
three­
year
approval
period
for
this
ICR
are
expected
only
to
involve
a
request
for
specific
information
that
is
necessary
to
meet
new
statutory
requirements,
EPA
estimates
that
it
might
issue
up
to
40
Registration
Review
DCIs
per
year.
This
is
the
same
estimate
the
Agency
used
in
the
previous
ICR.
The
Agency
continues
to
estimate
that,
on
average,
there
will
be
1.5
responses
per
DCI
for
a
total
of
60
responses
per
year.
As
with
Special
Review
DCI's,
Registration
Review
DCI's
may
request
data
on
more
than
one
pesticide,
and
may
involve
two
or
more
respondents
who
join
together
to
provide
the
needed
data.
DRAFT
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COMMENT
April
12,
2004
Page
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Table
1B:
Annual
Respondent
Burden/
Cost
Estimates
for
Registration
Review
DCIs
BURDEN
HOURS
(
per
year)
TOTALS
COLLECTION
ACTIVITIES
Mgmt.
$
130/
hr
Tech.
$
88/
hr
Cler.
$
40/
hr
Hrs
Cost
1)
Read
and
discuss
test
requirements
22
0
0
22
$
2,860
2)
Discuss
test
and
protocol
with
Agency
11
11
0
22
$
2,398
3)
Plan
activities
44
11
0
55
$
6,688
4)
Create
information
33
544
33
610
$
53,482
5)
Gather
information
0
54
0
54
$
4,752
6)
Process,
compile,
review
information
for
accuracy
65
87
0
152
$
16,106
7)
Complete
written
forms
0
0
22
22
$
880
8)
Record,
disclose,
display
information
22
0
44
66
$
4,620
9)
Store,
file,
or
maintain
information
22
0
38
60
$
4,380
TOTAL
219
707
137
1,063
$
96,166
Registration
Review
Total
Respondent
Burden
and
Cost
Per
Year
During
Three
Year
Period:
Hours:
60
responses
X
1,063
=
63,780
hours
Costs:
60
responses
X
$
96,166
=
$
5,769,960
Registration
Review
Total
Respondent
Burden
and
Cost
Over
Three
Years:
Hours:
180
responses
X
1,063
=
191,340
hours
Costs:
180
responses
X
$
96,166
=
$
17,309,880
6(
b).
Estimating
Respondent
Costs
Annual
Total:
For
Special
Review
DCIs,
the
total
annual
respondent
cost
is
estimated
to
be
$
81,934
($
81,934
per
response
x
1
response).
For
Registration
Review,
the
total
annual
respondent
cost
is
estimated
to
be
$
5,769,960
($
96,166
per
response
x
60
responses).
The
annual
totals
of
both
Special
Review
and
Registration
Review,
when
added
together,
will
be
$
5,851,894.
See
Tables
1A,
1B,
and
3.

Three­
year
ICR
approval
total:
For
Special
Review
DCIs,
the
total
respondent
cost
is
estimated
to
be
$
245,802
($
81,934
per
response
x
3
responses).
For
Registration
Review,
the
total
respondent
cost
is
estimated
to
be
$
17,309,880
($
96,166
per
response
x
180
responses).
The
totals
of
both
Special
Review
and
Registration
Review,
when
added
together,
will
be
$
17,555,
682.
See
last
row
of
Table
3.

The
methodology
for
estimating
the
total
potential
cost
associated
with
the
paperwork
activities
related
to
the
studies
conducted
to
respond
to
a
DCI
are
discussed
in
more
detail
in
Attachment
G.
The
labor
costs
were
derived
using
previous
cost
information
for
individual
Special
Review
DCIs
conducted
during
the
previous
approved
period.
Based
on
the
cost
information,
the
Agency
assumed
an
average
total
test
cost
of
$
500,000
per
Special
Review
DCI.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
17
of
55
This
cost
was
the
basis
for
calculating
the
value
of
labor
per
hour
for
management,
technical,
and
clerical,
which
is
$
130,
$
88,
and
$
40,
respectively.
These
hourly
rate
include
overhead
and
benefits
and
were
used
to
calculate
the
potential
costs
(
Tables
1A
and
1B
provide
the
details
on
the
calculations
of
these
costs).
This
analysis
assumes
one
registrant
will
generate
the
test
data
for
a
given
chemical;
if
a
consortium
takes
responsibility
for
the
data,
the
burden
and
cost
will
be
distributed
across
members
of
the
consortium.

6(
c).
Estimating
Agency
Burden
and
Cost
As
illustrated
in
Table
2A,
the
average
annual
Agency
cost
for
Special
Review
is
estimated
to
be
1,348
hours
and
$
91,404
per
response
with
one
annual
response,
for
a
total
annual
burden
of
1,348
(
1,348
x
1)
hours
and
cost
of
$
91,404.
In
this
ICR,
the
average
number
of
Agency
burden
hours
per
response
for
Special
Review
is
the
same
as
in
the
previous
ICR;
i.
e.,
1,348
hours.
Over
a
three­
year
ICR
approval
period,
3
responses
are
expected
and
the
total
Agency
burden
hour
and
cost
is
estimated
at
4,044
(
1,348
x
3)
hours,
with
a
cost
of
$
274,212.

As
illustrated
in
Table
2B,
the
average
annual
Agency
cost
for
Registration
Review
is
estimated
to
be
760
hours
and
$
47,376
per
response
with
60
annual
responses,
for
a
total
annual
burden
of
45,600
hours
(
760
x
60)
and
cost
of
$
2,842,560.
In
this
ICR,
the
average
number
of
Agency
burden
hours
per
response
for
Registration
Review
is
the
same
as
in
the
previous
ICR;
i.
e.,
760
hours.
Over
a
three­
year
ICR
approval
period,
180
responses
are
expected
and
the
total
Agency
burden
hour
and
cost
is
estimated
at
136,800
(
760
x
180)
hours,
with
a
cost
of
$
8,527,680.

The
hourly
rates
for
Agency
staff
are
$
96,
$
70,
and
$
33
per
hour
for
management,
technical,
and
clerical
staff,
respectively.
Agency
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.

Annual
Total:
The
total
annual
burden
for
the
Agency
to
administer
Special
Review
and
Registration
Review
DCI
responses
is
estimated
to
be
46,948
hours
and
cost
$
2,933,964.
See
Table
4.

Three­
year
ICR
approval
total:
Over
the
three­
year
approval
for
this
ICR,
the
total
burden
for
the
Agency
to
administer
all
Special
Review
and
Registration
DCI
responses
is
estimated
to
be
140,844
hours
and
cost
$
8,801,892.
See
the
last
row
of
Table
4.

The
Agency's
labor
burden
includes
developing
DCI
correspondence,
communication
with
registrants,
and
documenting
and
storing
the
evaluation
of
the
data
submissions.
The
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
96,
$
70,
and
$
33
(
revised
from
the
previous
ICR's
rates
of
$
84,
$
61,
and
$
29),
respectively.
Burden
cost
estimates
have
been
calculated
based
on
the
General
Schedule
(
GS)
hourly
rates
for
three
levels
of
Agency
personnel
as
follows:

Management
=
Branch
Chief
(
GS­
15)
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
18
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55
Technical
=
Section
Head
(
GS­
14)
&
Staff
Scientists
(
GS
9­
13).
Average
Grade
used
is
equal
to
GS­
12
Clerical
=
Secretary
(
GS­
6)

Table
2A:
Annual
Agency
Burden/
Cost
Estimates
for
Special
Review
DCIs
Collection
Activities
Burden
Hours
Total
Mgmt.
$
96/
hr
Tech.
$
70/
hr
Cler.
$
33/
hr
Hours
Cost
Develop
DCI
correspondence
needed
32
160
60
252
$
16,252
Answer
registrants'
questions
regarding
the
DCI
4
160
0
164
$
11,584
Review
and
analyze
data
submissions
4
880
0
884
$
61,984
Record
DCI
submissions
0
0
40
40
$
1,320
Store
Data
0
0
8
8
$
264
TOTAL
40
1,200
108
1,348
$
91,404
Annual
Agency
Burden
and
Cost
for
Special
Review
DCIs:
Hours:
1
response
X
1,348
=
1,348
hours
Cost:
1
response
X
$
91,404
=
$
91,404
Total
Agency
Burden
and
Cost
for
Special
Review
DCIs:
Hours:
3
responses
X
1,348
=
4,044
hours
Cost:
3
responses
X
$
91,404
=
$
274,212
Table
2B:
Annual
Agency
Burden/
Cost
Estimates
for
Registration
Review
DCIs
Collection
Activities
Burden
Hours
Total
Mgmt.
$
96/
hr
Tech.
$
70/
hr
Cler.
$
33/
hr
Hours
Cost
Develop
DCI
correspondence
needed
64
320
120
504
$
32,504
Answer
registrants'
questions
regarding
the
DCI
4
160
0
164
$
11,584
Review
and
analyze
data
submissions
4
0
0
4
$
384
Record
DCI
submissions
0
0
80
80
$
2,640
Store
Data
0
0
8
8
$
264
TOTAL
72
480
208
760
$
47,376
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
19
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55
Annual
Agency
Burden
and
Cost
for
Registration
Review
DCIs:
Hours:
60
responses
X
760
=
45,600
hours
Cost:
60
responses
X
$
47,376
=
$
2,842,560
Total
Agency
Burden
and
Cost
for
Registration
Review
DCIs:
Hours:
180
responses
X
760
=
136,800
hours
Cost:
180
responses
X
$
47,376
=
$
8,527,680
6(
d).
Bottom
Line
Burden
Hours
and
Cost
Tables
The
total
Respondent
burden
and
costs
are
illustrated
in
Table
3,
while
the
total
Agency
burden
and
costs
are
illustrated
in
Table
4.

Table
3:
Annual
and
Total
Respondent
Burden/
Cost
Estimates
Over
Three
Years
Per
Response
Number
of
Responses
Totals
Hours
Cost
Hours
Cost
Special
Review
919
$
81,934
1
919
$
81,934
Registration
Review
1,063
$
96,166
60
63,780
$
5,769,960
TOTAL
ANNUAL
BURDEN
1,982
$
178,100
61
64,699
$
5,851,894
TOTAL
BURDEN
5,946
$
534,300
183
194,097
$
17,555,682
Table
4:
Annual
and
Total
Agency
Burden/
Cost
Estimates
Over
Three
Years
Per
Response
Number
of
Responses
Totals
Hours
Costs
Hours
Cost
Special
Review
1,348
$
91,404
1
1,348
$
91,404
Registration
Review
760
$
47,376
60
45,600
$
2,842,560
TOTAL
ANNUAL
BURDEN
2,108
$
138,780
61
46,948
$
2,933,964
TOTAL
BURDEN
6,324
$
416,340
183
140,844
$
8,801,892
6(
e).
Reasons
for
Change
in
Burden
This
ICR
renewal
request
will
result
in
a
net
decrease
in
the
annual
respondent
burden
of
6,433
hours,
i.
e.,
from
7,352
hours
to
919
hours,
for
Special
Review
when
compared
with
the
previous
ICR.
The
Agency
has
adjusted
the
annual
number
of
Special
Review
DCIs
that
may
be
issued
(
from
2
to
1),
and
the
total
estimated
number
of
respondents
affected
(
from
4
to
1).
Based
on
experience,
and
the
Agency's
existing
work
plan,
EPA
believes
that
a
more
accurate
estimate
involves
the
prediction
of
up
to
1
Special
Review
DCI
being
issued
each
year,
with
each
DCI
affecting
1
respondent,
for
a
total
estimate
of
3
responses
over
a
three­
year
period.
This
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
20
of
55
adjustment
resulted
in
a
decrease
in
annual
burden
of
hours
due
to
a
reduction
in
total
annual
responses
from
8
(
2
x
4)
to
1
(
1
x
1).

Also,
EPA
has
updated
the
hourly
labor
rates
used
to
calculate
costs
for
the
respondent
to
$
130,
$
88,
and
$
40
(
up
from
$
123,
$
83,
and
$
38
in
the
previous
ICR)
for
management,
technical,
and
clerical
work,
respectively.
In
addition,
EPA
has
updated
the
hourly
labor
rates
used
to
calculate
costs
for
the
Agency
to
$
96,
$
70,
and
$
33
(
from
$
84,
$
61,
and
$
29)
for
management,
technical,
and
clerical
work,
respectively.

6(
f).
Burden
Statement
The
annual
respondent
burden
for
the
information
collection
activities
under
OMB
Control
Number
2070­
0057
(
EPA
ICR
#
922.07)
is
estimated
to
average
919
hours
for
Special
Review
DCIs
and
63,780
hours
for
Registration
Review
DCIs.
The
annual
respondent
burden
under
this
ICR
is
64,699
hours.
This
estimate
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
respond
to
a
collection
of
information;
search
existing
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
control
number
for
this
information
collection
appear
at
the
beginning
and
the
end
of
this
document,
on
the
forms
approved
under
this
ICR,
and
in
the
list
of
OMB
control
numbers
for
EPA's
regulations
in
40
CFR
9.1
(
see
Attachment
H
for
additional
information
about
40
CFR
9.1).

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPP­
2004­
0111,
which
is
available
for
public
viewing
at
the
OPP
Docket
in
the
Public
Information
and
Records
Integrity
Branch,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305­
5805.

An
electronic
version
of
the
public
docket
for
this
ICR
renewal
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPP­
2004­
0111
and
OMB
Control
No.
2070­
0057
in
any
correspondence.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
21
of
55
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
22
of
55
ATTACHMENTS
TO
THE
SUPPORTING
STATEMENT
Attachment
A
­
FIFRA,
sections
3(
c)(
2)(
B),
3(
c)(
2)(
D)
and
3(
g)
(
7
U.
S.
C.
136a).
Available
electronically
at
http://
www.
epa.
gov/
oppfead1/
fqpa/
and
click
on
"
LAWS,"
then
click
on
the
available
PDF
file
for
FIFRA.

Attachment
B
­
Data
Call­
In
Response
Form.

Attachment
C
­
Requirement
Status
and
Registrants'
Response
Form.

Attachment
D
­
EPA
Form
8570­
32
­
Certification
of
Attempt
to
Enter
into
an
Agreement
with
Registrants
for
Development
of
Data
­
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/

Attachment
E
­
EPA
Form
8570­
34
­
Certification
with
Respect
to
Citation
of
Data.
Available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/

Attachment
F
­
Pesticides;
Procedural
Regulations
for
Registration
Review;
Advanced
Notice
of
Proposed
Rulemaking
(
65
FR
24585,
April
26,
2000).
Available
electronically
at
http://
frwebgate.
access.
gpo.
gov/
cgi­
bin/
getdoc.
cgi?
dbname=
2000_
register&
docid=
00­
10433­
file
d
Attachment
G
­
Estimating
the
Potential
Paperwork
Burden
and
Cost
for
DCIs.
An
electronic
copy
of
this
attachment
follows
in
the
electronic
file
for
this
ICR.

Attachment
H
­
Display
Related
to
OMB
Control
#
2070­
0057
­
Listings
of
Related
Regulations
in
40
CFR
9.1.
An
electronic
copy
of
this
attachment
follows
in
the
electronic
file
for
this
ICR.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
23
of
55
Attachment
A
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
Section
3(
c)(
2)(
B)

(
2)
Data
in
Support
of
Registration.­­

(
A)
In
General.­­
The
Administrator
shall
publish
guidelines
specifying
the
kinds
of
information
which
will
be
required
to
support
the
registration
of
a
pesticide
and
shall
revise
such
guidelines
from
time
to
time.
If
thereafter
the
Administrator
requires
any
additional
kind
of
information
under
subparagraph
(
B)
of
this
paragraph,
the
Administrator
shall
permit
sufficient
time
for
applicants
to
obtain
such
additional
information.
The
Administrator,
in
establishing
standards
for
data
requirements
for
the
registration
of
pesticides
with
respect
to
minor
uses,
shall
make
such
standards
commensurate
with
the
anticipated
extent
of
use,
pattern
of
use,
the
public
health
and
agricultural
need
for
such
minor
use,
and
the
level
and
degree
of
potential
beneficial
or
adverse
effects
on
man
and
the
environment.

The
Administrator
shall
not
require
a
person
to
submit,
in
relation
to
a
registration
or
reregistration
of
a
pesticide
for
minor
agricultural
use
under
this
Act,
any
field
residue
data
from
a
geographic
area
where
the
pesticide
will
not
be
registered
for
such
use.
In
the
development
of
these
standards,
the
Administrator
shall
consider
the
economic
factors
of
potential
national
volume
of
use,
extent
of
distribution,
and
the
impact
of
the
cost
of
meeting
the
requirements
on
the
incentives
for
any
potential
registrant
to
undertake
the
development
of
the
required
data.
Except
as
provided
by
section
10,
within
30
days
after
the
Administrator
registers
a
pesticide
under
this
Act
the
Administrator
shall
make
available
to
the
public
the
data
called
for
in
the
registration
statement
together
with
such
other
scientific
information
as
the
Administrator
deems
relevant
to
the
Administrator's
decision.

(
B)
Additional
Data.­­(
i)
If
the
Administrator
determines
that
additional
data
are
required
to
maintain
in
effect
an
existing
registration
of
a
pesticide,
the
Administrator
shall
notify
all
existing
registrants
of
the
pesticide
to
which
the
determination
relates
and
provide
a
list
of
such
registrants
to
any
interested
person.

(
ii)
Each
registrant
of
such
pesticide
shall
provide
evidence
within
ninety
days
after
receipt
of
notification
that
it
is
taking
appropriate
steps
to
secure
the
additional
data
that
are
required.

Two
or
more
registrants
may
agree
to
develop
jointly,
or
to
share
in
the
cost
of
developing,
such
data
if
they
agree
and
advise
the
Administrator
of
their
intent
within
ninety
days
after
notification.

Any
registrant
who
agrees
to
share
in
the
cost
of
producing
the
data
shall
be
entitled
to
examine
and
rely
upon
such
data
in
support
of
maintenance
of
such
registration.
The
Administrator
shall
issue
a
notice
of
intent
to
suspend
the
registration
of
a
pesticide
in
accordance
with
the
procedures
prescribed
by
clause
(
iv)
if
a
registrant
fails
to
comply
with
this
clause.

(
iii)
If,
at
the
end
of
sixty
days
after
advising
the
Administrator
of
their
agreement
to
develop
jointly,
or
share
in
the
cost
of
developing,
data,
the
registrants
have
not
further
agreed
on
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the
terms
of
the
data
development
arrangement
or
on
a
procedure
for
reaching
such
agreement,
any
of
such
registrants
may
initiate
binding
arbitration
proceedings
by
requesting
the
Federal
Mediation
and
Conciliation
Service
to
appoint
an
arbitrator
from
the
roster
of
arbitrators
maintained
by
such
Service.
The
procedure
and
rules
of
the
Service
shall
be
applicable
to
the
selection
of
such
arbitrator
and
to
such
arbitration
proceedings,
and
the
findings
and
determination
of
the
arbitrator
shall
be
final
and
conclusive,
and
no
official
or
court
of
the
United
States
shall
have
power
or
jurisdiction
to
review
any
such
findings
and
determination,
except
for
fraud,
misrepresentation,
or
other
misconduct
by
one
of
the
parties
to
the
arbitration
or
the
arbitrator
where
there
is
a
verified
complaint
with
supporting
affidavits
attesting
to
specific
instances
of
such
fraud,
misrepresentation,
or
other
misconduct.
All
parties
to
the
arbitration
shall
share
equally
in
the
payment
of
the
fee
and
expenses
of
the
arbitrator.
The
Administrator
shall
issue
a
notice
of
intent
to
suspend
the
registration
of
a
pesticide
in
accordance
with
the
procedures
prescribed
by
clause
(
iv)
if
a
registrant
fails
to
comply
with
this
clause.

(
iv)
Notwithstanding
any
other
provision
of
this
Act,
if
the
Administrator
determines
that
a
registrant,
within
the
time
required
by
the
Administrator,
has
failed
to
take
appropriate
steps
to
secure
the
data
required
under
this
subparagraph,
to
participate
in
a
procedure
for
reaching
agreement
concerning
a
joint
data
development
arrangement
under
this
subparagraph
or
in
an
arbitration
proceeding
as
required
by
this
subparagraph,
or
to
comply
with
the
terms
of
an
agreement
or
arbitration
decision
concerning
a
joint
data
development
arrangement
under
this
subparagraph,
the
Administrator
may
issue
a
notice
of
intent
to
suspend
such
registrant's
registration
of
the
pesticide
for
which
additional
data
is
required.
The
Administrator
may
include
in
the
notice
of
intent
to
suspend
such
provisions
as
the
Administrator
deems
appropriate
concerning
the
continued
sale
and
use
of
existing
stocks
of
such
pesticide.
Any
suspension
proposed
under
this
subparagraph
shall
become
final
and
effective
at
the
end
of
thirty
days
from
receipt
by
the
registrant
of
the
notice
of
intent
to
suspend,
unless
during
that
time
a
request
for
hearing
is
made
by
a
person
adversely
affected
by
the
notice
or
the
registrant
has
satisfied
the
Administrator
that
the
registrant
has
complied
fully
with
the
requirements
that
served
as
a
basis
for
the
notice
of
intent
to
suspend.
If
a
hearing
is
requested,
a
hearing
shall
be
conducted
under
section
6(
d)
of
this
Act.
The
only
matters
for
resolution
at
that
hearing
shall
be
whether
the
registrant
has
failed
to
take
the
action
that
served
as
the
basis
for
the
notice
of
intent
to
suspend
the
registration
of
the
pesticide
for
which
additional
data
is
required,
and
whether
the
Administrator's
determination
with
respect
to
the
disposition
of
existing
stocks
is
consistent
with
this
Act.
If
a
hearing
is
held,
a
decision
after
completion
of
such
hearing
shall
be
final.
Notwithstanding
any
other
provision
of
this
Act,
a
hearing
shall
be
held
and
a
determination
made
within
seventy­
five
days
after
receipt
of
a
request
for
such
hearing.
Any
registration
suspended
under
this
subparagraph
shall
be
reinstated
by
the
Administrator
if
the
Administrator
determines
that
the
registrant
has
complied
fully
with
the
requirements
that
served
as
a
basis
for
the
suspension
of
the
registration.

(
v)
Any
data
submitted
under
this
subparagraph
shall
be
subject
to
the
provisions
of
paragraph
(
1)(
D).
Whenever
such
data
are
submitted
jointly
by
two
or
more
registrants,
an
agent
shall
be
agreed
on
at
the
time
of
the
joint
submission
to
handle
any
subsequent
data
compensation
matters
for
the
joint
submitters
of
such
data.
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(
vi)
Upon
request
of
a
registrant
the
Administrator
shall,
in
the
case
of
a
minor
use,
extend
the
deadline
for
the
production
of
residue
chemistry
data
under
this
subparagraph
for
data
required
solely
to
support
that
minor
use
until
the
final
deadline
for
submission
of
data
under
section
4
for
the
other
uses
of
the
pesticide
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996,
if
B
(
I)
the
data
to
support
other
uses
of
the
pesticide
on
a
food
are
being
provided;

(
II)
the
registrant,
in
submitting
a
request
for
such
an
extension,
provides
a
schedule,
including
interim
dates
to
measure
progress,
to
assure
that
the
data
production
will
be
completed
before
the
expiration
of
the
extension
period;

(
III)
the
Administrator
has
determined
that
such
extension
will
not
significantly
delay
the
Administrator's
schedule
for
issuing
a
reregistration
eligibility
determination
required
under
section
4;
and
(
IV)
the
Administrator
has
determined
that
based
on
existing
data,
such
extension
would
not
significantly
increase
the
risk
of
any
unreasonable
adverse
effect
on
the
environment.
If
the
Administrator
grants
an
extension
under
this
clause,
the
Administrator
shall
monitor
the
development
of
the
data
and
shall
ensure
that
the
registrant
is
meeting
the
schedule
for
the
production
of
the
data.
If
the
Administrator
determines
that
the
registrant
is
not
meeting
or
has
not
met
the
schedule
for
the
production
of
such
data,
the
Administrator
may
proceed
in
accordance
with
clause
(
iv)
regarding
the
continued
registration
of
the
affected
products
with
the
minor
use
and
shall
inform
the
public
of
such
action.
Notwithstanding
the
provisions
of
this
clause,
the
Administrator
may
take
action
to
modify
or
revoke
the
extension
under
this
clause
if
the
Administrator
determines
that
the
extension
for
the
minor
use
may
cause
an
unreasonable
adverse
effect
on
the
environment.
In
such
circumstance,
the
Administrator
shall
provide,
in
writing
to
the
registrant,
a
notice
revoking
the
extension
of
time
for
submission
of
data.
Such
data
shall
instead
be
due
in
accordance
with
the
date
established
by
the
Administrator
for
the
submission
of
the
data.

(
vii)
If
the
registrant
does
not
commit
to
support
a
specific
minor
use
of
the
pesticide,
but
is
supporting
and
providing
data
in
a
timely
and
adequate
fashion
to
support
uses
of
the
pesticide
on
a
food,
or
if
all
uses
of
the
pesticide
are
nonfat
uses
and
the
registrant
does
not
commit
to
support
a
specific
minor
use
of
the
pesticide
but
is
supporting
and
providing
data
in
a
timely
and
adequate
fashion
to
support
other
nonfat
uses
of
the
pesticide,
the
Administrator,
at
the
written
request
of
the
registrant,
shall
not
take
any
action
pursuant
to
this
clause
in
regard
to
such
unsupported
minor
use
until
the
final
deadline
established
as
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996,
for
the
submission
of
data
under
section
4
for
the
supported
uses
identified
pursuant
to
this
clause
unless
the
Administrator
determines
that
the
absence
of
the
data
is
significant
enough
to
cause
human
health
or
environmental
concerns.
On
the
basis
of
such
determination,
the
Administrator
shall
publish
in
the
Federal
Register
a
notice
of
the
receipt
of
the
request
and
the
effective
date
upon
which
the
uses
not
being
supported
will
be
voluntarily
deleted
from
the
registration
pursuant
to
section
6(
f)(
1).
If
the
Administrator
grants
an
extension
under
this
clause,
the
Administrator
shall
monitor
the
development
of
the
data
for
the
uses
being
supported
and
shall
ensure
that
the
registrant
is
meeting
the
schedule
for
the
production
of
such
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data.
If
the
Administrator
determines
that
the
registrant
is
not
meeting
or
has
not
met
the
schedule
for
the
production
of
such
data,
the
Administrator
may
proceed
in
accordance
with
clause
(
iv)
of
this
subparagraph
regarding
the
continued
registration
of
the
affected
products
with
the
minor
and
other
uses
and
shall
inform
the
public
of
such
action
in
accordance
with
section
6(
f)(
2).
Notwithstanding
the
provisions
of
this
clause,
the
Administrator
may
deny,
modify,
or
revoke
the
temporary
extension
under
this
subparagraph
if
the
Administrator
determines
that
the
continuation
of
the
minor
use
may
cause
an
unreasonable
adverse
effects
on
the
environment.
In
the
event
of
modification
or
revocation,
the
Administrator
shall
provide,
in
writing,
to
the
registrant
a
notice
revoking
the
temporary
extension
and
establish
a
new
effective
date
by
which
the
minor
use
shall
be
deleted
from
the
registration.

(
viii)
(
I)
If
data
required
to
support
registration
of
a
pesticide
under
subparagraph
(
A)
is
requested
by
a
Federal
or
State
regulatory
authority,
the
Administrator
shall,
to
the
extent
practicable,
coordinate
data
requirements,
test
protocols,
timetables,
and
standards
of
review
and
reduce
burdens
and
redundancy
cause
to
the
registrant
by
multiple
requirements
on
the
registrant.

(
II)
The
Administrator
may
enter
into
a
cooperative
agreement
with
a
State
to
carry
out
subclause
(
I).

(
III)
Not
later
than
1
year
after
the
date
of
enactment
of
this
clause,
the
Administrator
shall
develop
a
process
to
identify
and
assist
in
alleviating
future
disparities
between
Federal
and
State
data
requirements.

(
C)
Simplified
Procedures.­­
Within
nine
months
after
the
date
of
enactment
of
this
subparagraph,
the
Administrator
shall,
by
regulation,
prescribe
simplified
procedures
for
the
registration
of
pesticides,
which
shall
include
the
provisions
of
subparagraph
(
D)
of
this
paragraph.

(
D)
Exemption.­­
No
applicant
for
registration
of
a
pesticide
who
proposes
to
purchase
a
registered
pesticide
from
another
producer
in
order
to
formulate
such
purchased
pesticide
into
the
pesticide
that
is
the
subject
of
the
application
shall
be
required
to
B
(
i)
submit
or
cite
data
pertaining
to
such
purchased
product;
or
(
ii)
offer
to
pay
reasonable
compensation
otherwise
required
by
paragraph
(
1)(
D)
of
this
subsection
for
the
use
of
any
such
data.

(
E)
Minor
Use
Waiver.­­
In
handling
the
registration
of
a
pesticide
for
a
minor
use,
the
Administrator
may
waive
otherwise
applicable
data
requirements
if
the
Administrator
determines
that
the
absence
of
such
data
will
not
prevent
the
Administrator
from
determining­­

(
i)
the
incremental
risk
presented
by
the
minor
use
of
the
pesticide;
and
(
ii)
that
such
risk,
if
any,
would
not
be
an
unreasonable
adverse
effect
on
the
environment.
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ATTACHMENT
F
[
Federal
Register:
April
26,
2000
(
Volume
65,
Number
81)]

[
Proposed
Rules]

[
Page
24585­
24591]
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Part
IV
Environmental
Protection
Agency
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

40
CFR
Part
152
Pesticides;
Procedural
Regulations
for
Registration
Review;
Advanced
Notice
of
Proposed
Rulemaking
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
152
[
OPP­
36195;
FRL­
6488­
9]

RIN
2070­
AD29
Pesticides;
Procedural
Regulations
for
Registration
Review
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Advanced
Notice
of
Proposed
Rulemaking.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
The
Food
Quality
Protection
Act
(
FQPA)
of
1996
amended
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
to
require
periodic
review
of
pesticide
registrations
to
ensure
that
over
time
they
continue
to
meet
statutory
standards
for
safety.
FIFRA
section
3(
g)
specifies
that
EPA
establish
procedural
regulations
for
conducting
registration
review
and
that
the
goal
of
the
regulations
shall
be
the
Agency
review
of
pesticide
registrations
on
a
15­
year
cycle.
This
advance
notice
of
proposed
rulemaking
(
ANPRM)
alerts
stakeholders
that
EPA
is
beginning
development
of
procedural
regulations
for
registration
review
under
FIFRA
section
3(
g).
It
explains
EPA's
preliminary
interpretation
of
the
authorizing
legislation,
presents
EPA's
goals
in
implementing
the
statutory
provisions,
presents
the
Agency's
initial
concept
of
how
the
registration
review
program
might
operate,
identifies
several
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
32
of
55
issues
that
should
be
addressed
in
developing
the
program,
and
invites
public
comment
on
these
and
other
issues
relating
to
registration
review.

DATES:
Comments,
identified
by
the
docket
control
number
[
OPP­
36195],
must
be
received
on
or
before
June
26,
2000.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP­
36195
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
Vivian
Prunier,
Field
and
External
Affairs
Division
(
7506C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
Ariel
Rios
Bldg.,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
703­
308­
9341;
fax
number:
703­
305­
5884;
e­
mail
address:
prunier.
vivian@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
the
planned
rulemaking
described
in
this
document
if
you
hold
pesticide
registrations
or
may
hold
pesticide
registrations
in
the
future.
Pesticide
users
or
other
persons
interested
in
the
regulation
of
the
sale,
distribution,
or
use
of
pesticides
may
also
be
interested
in
these
planned
procedural
rules.
As
such,
the
Agency
is
soliciting
comments
from
the
public
in
general.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
in
the
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document
on
the
Home
Page
select
  
Laws
and
Regulations''
and
then
look
up
the
entry
for
this
document
under
the
  
Federal
Register
B
Environmental
Documents.''
You
can
also
go
directly
to
the
  
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
33
of
55
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
[
OPP­
36195].
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(
CBI).

This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,

Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
Public
Information
and
Records
Integrity
Branch
telephone
number
is
703­
305­
5805.

C.
How
and
to
Whom
Do
I
Submit
Comments?

You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP­
36195
in
the
subject
line
on
the
first
page
of
your
response.

1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Ariel
Rios
Bldg.,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.

3.
Electronically.
You
may
submit
your
comments
electronically
by
e­
mail
to:
  
opp­
docket@
epa.
gov,''
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
control
number
OPP­
36195.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
That
I
Want
to
Submit
to
the
Agency?
DRAFT
FOR
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COMMENT
April
12,
2004
Page
34
of
55
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

We
invite
you
to
provide
your
views
on
the
various
issues
we
raise,
new
approaches
or
options
we
haven't
considered
and
the
potential
impacts,
including
possible
unintended
consequences,
of
the
Agency's
initial
concept.
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:

Explain
your
views
as
clearly
as
possible
and
provide
any
supporting
data
where
appropriate.

Describe
any
assumptions
that
you
used.

Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.

To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
Purpose
of
the
ANPRM
With
this
ANPRM,
the
Agency
presents
the
statutory
requirement
for
pesticide
registration
review
and
alerts
its
stakeholders
that
it
is
initiating
the
development
of
rulemaking
to
establish
procedures
for
a
registration
review
program.
Second,
the
Agency
explains
its
preliminary
interpretation
of
the
statutory
provisions
and
its
preliminary
ideas
regarding
goals
and
objectives
for
this
program.
Third,

the
Agency
describes
its
preliminary
ideas
about
how
registration
review
might
operate.
Fourth,
the
Agency
solicits
public
input
on
critical
issues
about
registration
review
early
in
the
planning
process.
Finally,
EPA
solicits
public
input
to
identify
potential
problems
as
early
as
possible.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
35
of
55
III.
Legal
Authority
A.
EPA's
Authority
to
License
Pesticide
Products
FIFRA
sections
3(
a)
and
12(
a)(
1)
require
a
person
to
register
a
pesticide
product
with
the
EPA
before
the
pesticide
product
may
be
lawfully
sold
or
distributed
in
the
United
States.
A
pesticide
registration
is
a
license
that
allows
a
pesticide
product
to
be
sold
and
distributed
for
specific
uses
under
specified
terms
and
conditions
such
as
use
instructions
and
precautions.
A
pesticide
product
may
be
registered
or
remain
registered
only
if
it
meets
the
statutory
standard
for
registration
given
in
FIFRA
section
3(
c)(
5),
as
follows:

(
A)
Its
composition
is
such
as
to
warrant
the
proposed
claims
for
it.

(
B)
Its
labeling
and
other
material
required
to
be
submitted
comply
with
the
requirements
of
this
Act.

(
C)
It
will
perform
its
intended
function
without
unreasonable
adverse
effects
on
the
environment.

(
D)
When
used
in
accordance
with
widespread
and
commonly
recognized
practice
it
will
not
generally
cause
unreasonable
adverse
effects
on
the
environment.

FIFRA
2(
bb)
defines
  
unreasonable
adverse
effects
on
the
environment''
as
(
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.''

The
proponent
of
initial
or
continued
registration
always
bears
the
burden
of
demonstrating
that
a
pesticide
product
meets
the
statutory
standard
for
registration.

B.
EPA's
Authority
for
Registration
Review
The
FQPA
amended
FIFRA
to
add,
among
other
things,
section
3(
g),
  
REGISTRATION
REVIEW,''
as
follows:
DRAFT
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PUBLIC
COMMENT
April
12,
2004
Page
36
of
55
(
1)(
A)
GENERAL
RULE.
The
registrations
of
pesticides
are
to
be
periodically
reviewed.
The
Administrator
shall
by
regulation
establish
a
procedure
for
accomplishing
the
periodic
review
of
registrations.
The
goal
of
these
regulations
shall
be
a
review
of
a
pesticide's
registration
every
15
years.
No
registration
shall
be
canceled
as
a
result
of
the
registration
review
process
unless
the
Administrator
follows
the
procedures
and
substantive
requirements
of
section
6.

(
B)
LIMITATION.
Nothing
in
this
subsection
shall
prohibit
the
Administrator
from
undertaking
any
other
review
of
a
pesticide
pursuant
to
this
Act.

(
2)(
A)
DATA.
The
Administrator
shall
use
the
authority
in
subsection
(
c)(
2)(
B)
to
require
the
submission
of
data
when
such
data
are
necessary
for
a
registration
review.

(
B)
DATA
SUBMISSION,
COMPENSATION,
AND
EXEMPTION.
B
For
purposes
of
this
subsection,
the
provisions
of
subsections
(
c)(
1),
(
c)(
2)(
B),
and
(
c)(
2)(
D)
shall
be
utilized
for
and
be
applicable
to
any
data
required
for
registration
review.

IV.
What
is
Registration
Review?

EPA
believes
that
  
registration
review''
would
consist
of
the
review
of
a
pesticide
to
determine
whether
the
pesticide
continues
to
meet
the
statutory
standard
for
registration
under
FIFRA
section
3(
c)(
5).
During
a
registration
review,
EPA
would
evaluate
elements
of
FIFRA
3(
c)(
5)
including
the
composition,
labeling
and
other
required
material
(
including
studies
and
other
data),
risks
and
benefits
of
a
pesticide,
and
incident
data
or
other
information
relating
to
its
use.
FIFRA
section
3(
g)
contemplates
that
EPA
may
determine
whether
or
not
a
pesticide
meets
the
statutory
standard
for
registration
in
FIFRA
section
3(
c)(
5).
If
EPA
determines
that
a
pesticide
no
longer
meets
the
statutory
standard,
it
should
not
remain
registered.
In
this
event,
EPA
may
need
to
pursue
other
actions
such
as
cancellation
under
other
statutory
authority.

FIFRA
section
3(
g)
instructs
EPA
to
establish,
by
regulation,
a
procedure
for
accomplishing
registration
review.
The
goal
of
these
regulations
shall
be
Agency
review
of
pesticide
registrations
on
a
15­
year
cycle.
EPA
believes
the
activities
that
should
be
addressed
under
the
procedural
regulations
include,
but
are
not
limited
to:
setting
priorities
for
review,
establishing
a
mechanism
for
setting
schedules
for
reviewing
all
pesticides
every
15
years,
and
articulating
the
general
approach
to
conducting
and
concluding
the
review.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
37
of
55
FIFRA
section
3(
g)
also
instructs
the
Agency
to
rely
on
existing
authorities
for
data
submission,
data
compensation,
data
exemption,
or
cancellation
of
registrations.
Therefore,
the
procedural
regulations
need
not
be
concerned
with
procedures
for
acquiring
new
information,

assuring
compensation
for
data
developers,
data
exemption,
or
canceling
a
pesticide
registration.
Authorities
and
procedures
for
such
activities
already
exist
and
FIFRA
3(
g)
did
not
require
EPA
to
develop
alterative
procedures
for
these
activities.
Existing
regulations
such
as
those
concerning
good
laboratory
practice
for
data
generation
and
FIFRA
section
8
recordkeeping
requirements
would
also
apply.
EPA
has
already
issued
regulations
and
guidelines
under
FIFRA
3(
c)(
2)(
A)
to
specify
the
kinds
of
information
that
are
required
to
support
a
pesticide
registration.
EPA
modifies
this
guidance
periodically
to
reflect
new
developments
in
science
areas
such
as
hazard
characterization
and
exposure
assessment.
Additionally,
as
explained
in
an
October
29,
1998
Federal
Register
notice
(
63
FR
58030)

(
FRL­
6041­
5),
EPA
is
in
the
process
of
issuing
guidance
for
meeting
the
new
safety
standard
mandated
by
the
FQPA.
Accordingly
it
is
not
necessary
to
specify
such
information
in
procedural
regulations
issued
under
FIFRA
section
3(
g)(
1)(
A).

EPA
may
determine
that
reviews
accomplished
under
other
authorities,
e.
g.,
section
408
of
the
FFDCA,
could
potentially
contribute
to
registration
reviews.
In
any
event,
EPA
believes
that
it
would
not
be
necessary
to
specify
procedures
for
these
activities
because
authorities
and
procedures
already
exist
for
them.

Finally,
FIFRA
section
3(
g)(
1)(
B)
stipulates
that
EPA
retains
its
authority
to
undertake
any
other
review
of
a
pesticide
under
FIFRA.
This
provision
means
that
EPA
may
continue
to
undertake
any
review
that
is
authorized
by
FIFRA
or
EPA
regulations
such
as
reregistration
or
special
review.
EPA
also
interprets
this
provision
to
mean,
among
other
things,
that
the
Agency
may
continue
its
practice
of
requiring
submission
of
data
whenever
the
Agency
believes
that
such
data
are
needed
to
support
the
continued
registration
of
a
pesticide.

V.
What
are
EPA's
Goals
for
Registration
Review?

EPA's
ultimate
goal
for
registration
review
is
to
ensure
continued
protection
of
human
health
and
the
environment
throughout
the
  
life''
of
each
pesticide's
registration.
To
achieve
this
goal,
EPA
will
periodically
review
all
pesticide
registrations
to
assure
that
they
continue
to
meet
the
FIFRA
statutory
standard
for
registration
based
on
the
science,
policies,
and
regulations
current
at
the
time
of
the
review.
EPA
will
conduct
this
review
efficiently
and
effectively
by
building
on
existing
knowledge
about
the
pesticide.
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EPA
will
evaluate
any
new
test
data,
monitoring
data,
and
field
information.
EPA
will
consider
the
effects
of
any
changes
in
data
requirements,
risk
assessment
methodologies
and
labeling
policies.
If
the
risk
assessment
changes
for
any
of
these
reasons,
EPA
may
need
to
change
the
regulatory
requirements
pertaining
to
the
registration.
In
some
cases,
EPA
may
find
significant
new
risks
that
were
not
considered
when
the
pesticide
was
registered
or
reregistered.
This
could
trigger
further
review
of
risks
or
benefits.
In
such
cases,
EPA
may
determine
that
the
pesticide
does
not
meet
the
statutory
standard
for
registration
under
FIFRA
section
3(
c)(
5)
and
therefore
should
not
remain
registered.
In
other
cases,
EPA
may
find
that
originally
it
had
overestimated
risks
and
it
may
be
possible
to
ease
regulatory
restrictions.

A.
Keeping
a
Registration
Up­
to­
Date
EPA
has
identified
several
aspects
involved
in
keeping
a
pesticide
registration
up­
to­
date.
These
include
receipt
of
new
data;

changes
in
data
requirements
and
associated
test
guidelines
(
or
protocols);
changes
in
risk
assessment
methods;
new
information
gained
through
use
and
practical
experience
with
a
pesticide;
and
changes
in
labeling
policy.

1.
Availability
of
new
data.
At
any
time,
registrants
or
other
persons
may
submit
new
studies
on
a
pesticide.
These
studies
may
be
undertaken
in
response
to
an
Agency
request
or
upon
the
data
generator's
own
initiative.
FIFRA
section
6(
a)(
2)
requires
submission
of
certain
kinds
of
data,
as
specified
in
40
CFR
part
159.

2.
Changes
in
data
requirements
and
test
guidelines.
From
time
to
time,
EPA
changes
data
requirements
or
testing
guidelines
to
reflect
advances
in
the
science
of
hazard
characterization
or
exposure
assessment.
When
changes
are
significant,
EPA
may
require
registrants
to
submit
new
testing
to
EPA
to
support
registration.
New
testing
may
be
necessary
to
evaluate
an
aspect
of
toxicity
or
exposure
that
was
not
previously
considered,
to
replace
particular
studies
that
are
no
longer
adequate
as
a
result
of
advances
in
test
design
or
protocols,
or
for
many
other
possible
reasons.

3.
Changes
in
risk
assessment
methodologies.
EPA
continually
seeks
to
improve
its
risk
assessment
methodologies.
Currently,
the
Agency
is
reviewing
a
number
of
risk
assessment
methodologies
as
part
of
its
implementation
of
the
FQPA.
Undoubtedly,
there
will
be
further
changes
as
science
and
policy
advance.

4.
Use
and
practical
experience
with
a
pesticide.
EPA
evaluates
whether
practical
experience
from
using
a
pesticide
changes
our
understanding
of
the
risks
and
benefits
of
the
pesticide.
EPA
has
established
registrant
reporting
requirements
for
risk/
benefit
information
(
see
40
CFR
part
159)
and
has
a
process
for
quickly
assessing
the
safety
implications
of
such
information.
The
EPA
will
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also
maintain
incident
databases,
sponsor
a
toll
free
telephone
service
that
gathers
information
related
to
pesticide
incident,
and
obtain
incident
related
information
from
poison
control
centers.
In
addition,
EPA
is
considering
the
establishment
of
a
Pesticide
Field
Data
Plan
for
capturing
key
information
about
pesticide
use
or
misuse.
Under
this
plan,
States
would
standardize
their
procedures
for
collecting
and
reporting
information
from
State
pesticide
compliance
and
enforcement
records.
EPA
would
analyze
information
from
thousands
of
federally­
funded
investigations
and
inspections
for
trends
and
patterns
of
problems
related
to
pesticide
use
or
misuse.

EPA
may
eventually
be
able
to
use
these
analyses
to
shape
or
confirm
regulatory
decisions.

5.
Changes
in
labeling
policy.
From
time
to
time,
EPA
publishes
guidance
on
the
format
and
content
of
pesticide
product
labels.

EPA
would,
as
part
of
registration
review,
evaluate
existing
labeling
to
determine
whether
it
needs
to
be
changed
to
reflect
current
policies
and
regulations
pertaining
to
matters
such
as
restrictions
in
use,
requirements
for
protective
clothing,
and
other
precautionary
label
language
associated
with
reducing
exposure
and
environmental
risk.
Additionally,
EPA
may
assess
alternative
ways
to
communicate
risk
management
information
to
pesticide
users.

B.
Incorporate
Lessons
Learned
from
Reregistration
FIFRA
section
4,
established
by
the
1988
amendments
to
FIFRA,
instructed
EPA
to
review
the
human
health
and
environmental
effects
of
all
pesticide
active
ingredients
originally
registered
before
November
1,
1984,
in
order
to
determine
whether
they
are
eligible
for
reregistration.
To
be
  
eligible,''
an
older
pesticide
must
have
a
substantially
complete
data
base,
and
must
be
found
not
to
cause
unreasonable
risks
to
man
or
the
environment
when
used
in
accordance
with
its
approved
labeling.
As
of
August
1,
1999,
of
612
reregistration
cases
(
composed
of
a
pesticide
active
ingredient
or
group
of
related
pesticide
active
ingredients),
415
cases
have
completed
reregistration
(
including
231
cases
where
registrants
requested
voluntary
cancellation
of
all
registrations
of
the
pesticide).

That
leaves
197
cases
awaiting
reregistration
decisions.

The
Agency's
experience
with
the
reregistration
program
offers
insights
into
the
construction
of
an
efficient
registration
review
program.
Chief
among
these
are
the
importance
of
effective
organization
of
large
quantities
of
data
for
review,
the
efficient
conduct
of
the
review
of
these
data,
and
the
need
for
flexibility
in
defining
the
scope
of
the
review
for
each
pesticide.
In
addition,
public
participation
at
critical
junctures
helps
ensure
that
the
Agency
develops
practical
risk
mitigation
measures
where
needed,
and
that
stakeholders
better
understand
the
bases
for
decisions.
To
the
extent
possible,
EPA
plans
to:

1.
Review
first
those
pesticide
registrations
for
which
EPA
believes
registration
review
will
produce
the
greatest
human
health
and
environmental
benefits.
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2.
Establish
methods
and
approaches
for
ensuring
that
it
has
all
necessary
data
to
make
good
regulatory
decisions
on
schedule.

3.
Standardize
data
submission
by
adopting
guidance
for
data
submitters
such
as
the
guidance
developed
by
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).
Standard
submission
formats
could
expedite
EPA's
review
and
promote
sharing
the
work
of
pesticide
evaluation
with
other
governments.

4.
Review
related
pesticides
simultaneously.
This
would
allow
effective
use
of
review
resources
and
promote
more
practical
and
comprehensive
risk
mitigation
measures.

5.
Tailor
the
level
and
nature
of
the
review
to
the
specific
facts
and
concerns
of
each
case.

6.
Build
on
the
results
of
prior
review
efforts
such
as
reregistration
and
tolerance
reassessment
and
on
updates
such
as
evaluations
of
applications
for
registration
of
new
uses.
EPA
would
avoid
re­
reviewing
data
to
the
fullest
extent
possible.

7.
Adopt,
or
use
to
the
extent
practicable,
state
and
foreign
governments'
reviews
of
pesticide
studies.
For
several
years,
EPA
has
been
developing
experience
in
sharing
the
work
of
pesticide
evaluation
with
North
American
Free
Trade
Agreement
(
NAFTA)

partners.
We
intend
to
build
on
this
experience
by
developing
work
share
relationships
with
additional
countries
through
OECD
initiatives.

8.
Standardize
its
approach
to
documenting
data
reviews
by
adapting
OECD
guidance
for
development
of
government
monographs.

Standard
formats
would
promote
sharing
work
between
countries
and
can
enhance
understanding
of
EPA
reviews.

9.
Seek
stakeholder
views
and
input
through
an
open
process
that
offers
the
public
and
the
regulated
community
clearly
defined,

time­
limited,
opportunities
for
input
to
various
aspects
of
the
review
process
for
an
individual
pesticide.

VI.
EPA's
Initial
Thinking
on
How
Registration
Review
Might
Operate
EPA
has
developed
an
initial
concept
for
registration
review,
which
is
presented
in
this
document.
It
is
intended
to
stimulate
thought
about
and
comment
on
all
aspects
of
developing
procedures
to
implement
registration
review.
EPA
believes
that
the
conceptual
model
presented
in
this
Unit
meets
the
statutory
requirements
and
Agency
goals
and
objectives
for
the
registration
review
program
for
all
pesticides.
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EPA
intends
for
registration
review
to
be
implemented
within
the
next
5
years.
EPA
expects
that
the
reregistration
program
will
be
completed
by
then,
and
the
registration
review
program
will
become
the
Agency's
primary
review
program
for
all
pesticide
registrations.
We
anticipate
that
the
registration
review
program
will
incorporate
the
application
of
the
FQPA
safety
standard
and,
as
appropriate,
the
use
of
reviews
conducted
under
other
authorities
and
programs
such
as
reregistration,
tolerance
assessment
and
reassessment,
and
our
proposed
endocrine
disrupter
screening
program.
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VII.
EPA's
Initial
Conceptual
Model
This
conceptual
model
has
five
steps.
EPA
expects
that
each
pesticide
would
start
registration
review
at
step
one
and
proceed
stepwise
through
the
process.
At
key
points
in
the
conceptual
model,
EPA
may
decide
to
omit
one
or
more
steps
in
the
registration
review
of
a
pesticide.
Registrants
who
are
responsible
for
generating
generic
data
on
an
active
ingredient
would
likely
be
involved
in
all
five
steps
of
the
process
described
in
this
preliminary
model.
Registrants
who
are
generally
not
responsible
for
generating
generic
data
would
likely
participate
in
fewer
steps.

A.
Step
1:
Plan
and
Schedule
Candidates
for
Review
The
first
step
in
EPA's
conceptual
model
of
a
Registration
Review
Program
would
be
planning
and
scheduling
of
pesticides
for
review.
This
step
might
consist
of
two
tasks:
(
1)
Assembling
the
historic
record;
and
(
2)
selecting
and
prioritizing
candidates.

EPA
would
assemble
the
historic
record
for
a
pesticide,
including
prior
reviews
and
associated
documentation
(
for
example,
a
Registration
Eligibility
Document
(
RED)
if
the
pesticide
had
been
evaluated
in
the
reregistration
program);
use
and
enforcement
history,
including
information
on
compliance
with
Good
Laboratory
Practice
regulations
and
other
FIFRA
requirements.
The
selection
and
priority
of
candidates
for
review
would
depend
on
a
number
of
factors
such
as:
(
1)
The
relative
importance
of
benefits
to
human
health
and
the
environment
which
might
accrue
by
completing
the
review
of
a
particular
pesticide;
(
2)
whether
the
pesticide
is
part
of
a
class
or
group
that
should
be
considered
together;
(
3)
state
of
the
data
base
relative
to
current
guideline
requirements;
(
4)
length
of
time
since
last
comprehensive
review;
(
5)
incident
data,
existence
of
information
required
to
be
submitted
under
FIFRA
section
6(
a)(
2);
(
6)
any
compliance
issues;
and
(
7)
the
pesticide's
status
in
the
reregistration
and
tolerance
reassessment
programs.

B.
Step
2:
Publish
Schedule,
Define
Initial
Scope
and
Level
of
Review,
and
Issue
Needed
Data
Call­
Ins
and
Requests
for
Applications
for
Scheduled
Candidates
The
second
step
would
also
consist
of
two
principle
tasks:
(
1)
publication
in
the
Federal
Register
of
the
list
of
review
candidates
and
the
tentative
schedule
for
review;
and
(
2)
case­
specific
determinations
of
the
level
and
scope
of
review
and
the
development
of
needed
data
call­
in
notices.

EPA
believes
that
the
schedule
for
registration
review
candidates
should
be
announced
at
least
5
years
in
advance
of
the
review
to
provide
time
for
generating
and
submitting
new
data.
In
addition
to
publishing
a
Federal
Register
notice
listing
the
registration
review
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candidates,
EPA
could
publish
the
listing
in
the
Code
of
Federal
Regulations
(
CFR),
make
the
list
available
as
part
of
a
registration
review
docket,
and/
or
maintain
a
list
electronically
on
the
OPP
Internet
Home
Page.

In
making
case­
specific
determinations
about
the
level
and
scope
of
review
appropriate
to
any
given
pesticide,
EPA
might
conduct
a
preliminary
analysis
of
the
completeness
of
the
data
base;
the
potential
significance
of
any
real­
world
monitoring
and
field
data
collected
since
the
last
regulatory
action;
the
need
to
revise
the
risk
assessment
using
updated
methodologies;
and
any
applicable
labeling
policy
changes.
This
analysis
would
provide
an
initial
characterization
of
the
level
and
type
of
risks
possibly
posed
by
the
pesticide,
critical
data
needs,
and
an
early
assessment
of
the
appropriate
level
and
scope
of
review
(
e.
g.,
whether
tolerances
should
be
reassessed).
EPA
might
then
publish
a
pesticide­
specific
notice
in
the
Federal
Register
describing
the
preliminary
analysis,
the
initial
assessment
of
data
needs,
and
the
proposed
level
and
scope
of
review.
EPA
would
invite
comment
on
these
issues.
After
analysis
of
comments
received,
EPA
would
issue
notices
to
registrants
to
call­
in
any
needed
data
and
establish
a
deadline
for
submitting
applications
for
registration
review.

EPA
expects
that
the
deadline
set
for
the
submission
of
an
application
for
registration
review
will
depend
in
large
part
on
the
scope,

level,
and
focus
of
registration
review
for
the
pesticide
and
the
type
of
data
that
are
being
called
in.
The
case­
specific
determination
of
the
level
and
scope
of
review
may
show
that
the
pesticide
meets
the
requirements
of
FIFRA
section
3(
c)(
5)
and
that
no
additional
data
or
review
are
needed.
In
such
cases,
EPA
would
issue
a
preliminary
determination,
as
described
in
Step
4
below.

C.
Step
3:
Registrants
Submit
Applications
for
Review
The
third
step
would
be
the
registrant's
submission
of
an
application
for
registration
review.
EPA
envisions
that
the
registrant's
application
for
registration
review
would
contain
all
required
data
and
all
needed
use
and
usage
information
and
any
relevant
data
reviews
conducted
by
regulatory
officials
in
the
states
or
other
countries.
The
format
for
the
submission
could
be
modeled
after
the
OECD
data
submission
guidelines
noted
earlier
in
this
document.
The
application
might
also
include
the
registrant's
opinion
of
which
hazard,
exposure
or
risk
assessments
should
be
updated
(
possibly
including
an
evaluation
of
monitoring
data
and
their
impact
on
the
assessment),
the
registrant's
assessment
of
the
pesticide's
risks,
and
the
registrant's
risk
mitigation
proposals,
including
proposed
label
changes.
Finally,
if
the
registrant
is
considering
changes
in
the
pesticide
registration
that
would
result
in
changes
in
tolerances
for
the
pesticide,
a
tolerance
petition
might
be
needed,
along
with
the
appropriate
tolerance
petition
processing
fees.
The
tolerance
petition
processing
fees
would
be
based
on
the
new
tolerance
fee
schedule,
which
EPA
proposed
to
establish
as
required
by
FQPA
(
64
FR
31039,
June
9,
1999)
(
FRL­
6028­
2).
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EPA
would
screen
the
application
for
completeness,
identify
issues
and
questions,
and
decide
whether
any
issues
or
questions
warrant
public
discussion
before
proceeding
with
the
review.
EPA
does
not
anticipate
routinely
soliciting
public
input
at
this
stage
in
the
process
and
EPA
expects
that
most
pesticides
will
move
to
Step
4
without
a
public
meeting.
However,
in
those
cases
where,
for
example,
the
registrant's
application
potentially
raises
significant
risk­
related
issues
or
where
the
registrant
is
proposing
risk
mitigation
measures
which
would
potentially
be
of
interest
to
certain
stakeholders
­­
such
as
protective
clothing
requirements,

establishment
of
buffer
zones,
or
voluntary
cancellation
of
minor
uses,
EPA
would
expect
to
hold
a
public
meeting
before
progressing
to
Step
4.

D.
Step
4:
EPA
Conducts
the
Review
and
Issues
It
for
Public
Comment
The
fourth
step
would
be
to
conduct
the
registration
review.
This
review
could
include
evaluation
of
all
new
data
and
data
reviews
done
by
other
regulatory
officials,
review
and
evaluation
of
the
registrant's
risk
assessments
and
public
comments
(
including
data)

submitted
in
Step
3,
revision
of
the
Agency's
risk
assessments
(
where
necessary),
review
of
pesticide
labeling
for
conformance
to
current
policy,
and
development
of
proposed
risk
mitigation
measures.
At
this
step
in
the
process,
EPA
envisions
making
a
preliminary
determination
whether
the
pesticide
continues
to
meet
the
statutory
standard
for
registration
under
FIFRA
section
3(
c)(
5).

EPA
would
announce
the
availability
of
the
preliminary
determination
for
public
review
and
comment.

If
EPA
preliminarily
determines
that
the
pesticide
no
longer
meets
the
standard
for
registration
under
FIFRA
section
3(
c)(
5),
EPA
would
immediately
collect
and
review
any
benefits
information
which
it
believed
it
needed.
If
it
appears
that
there
would
be
a
significant
change
in
the
existing
registration,
EPA
would
seek
public
input
on
proposed
risk
management
action
before
taking
such
action.

E.
Step
5:
Consider
Comments,
Issue
Final
Review,
and
Review
Registrant's
Proposed
Labels
In
the
final
step
EPA
would
evaluate
public
comments
on
its
updated
risk
assessment
and
proposed
regulatory
position
and
issue
its
final
review.
EPA
would
request
submission
of
product­
specific
data
or
new
labels
if
the
registration
review
shows
that
they
are
needed.
In
cases
where
EPA
decides
that
the
registration
appears
to
no
longer
meet
the
requirements
for
registration
under
FIFRA
section
3(
c)(
5),
EPA
would
undertake
appropriate
regulatory
action,
including,
if
necessary,
cancellation
action
under
FIFRA
section
6.

VIII.
Issues
for
Public
Comment
DRAFT
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April
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2004
Page
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55
Although
EPA
is
soliciting
your
comments
on
all
aspects
of
the
discussion
presented
in
this
document
regarding
registration
review,
EPA
is
particularly
interested
in
receiving
your
comments
on
the
following
topics.
You
may
submit
comments
on
any
other
issue
related
to
registration
review,
including
your
own
views
on
what
registration
review
procedures
should
look
like.

1.
EPA's
interpretation
of
the
requirements
in
FIFRA
section
3(
g).
Do
you
agree
with
EPA's
interpretation
of
the
statutory
mandate
for
registration
review
as
set
forth
in
Unit
IV?
If
not,
why?
How
would
you
interpret
FIFRA
section
3(
g)?

2.
Interpretation
of
  
Review
of
a
Pesticide's
Registration
every
15
years.''
EPA
recognizes
that
there
may
be
various
interpretations
of
  
review
of
a
pesticide's
registration
every
15
years.''
This
term
could
be
interpreted
to
mean
that
EPA
would
complete
a
registration
review
of
each
pesticide
within
15
years
of
the
pesticide's
registration
or
reregistration.
This
term
could
also
be
interpreted
to
mean
that
the
Agency
would
complete
registration
reviews
of
all
pesticides
within
a
15­
year
period
that
could
begin
when
EPA's
procedural
regulations
for
registration
review
go
into
effect.

3.
Commencement
of
a
15­
year
registration
review
cycle.
The
Agency
believes
that
the
effective
date
of
the
procedural
regulations
for
registration
review
could
be
a
possible
starting
date
of
the
15­
year
period
for
completing
registration
review,
but
recognizes
that
another
date
or
series
of
dates
may
also
be
possible
starting
dates
for
registration
review.
Do
you
have
any
suggestions
for
designing
a
system
of
staggered
scheduling
for
registration
reviews?

4.
Goals
and
objectives
for
the
registration
review
program.
Do
you
agree
with
the
goals
that
EPA
has
identified?
What
changes
do
you
suggest?

5.
Relationship
of
registration
review
to
other
mandates.
A
key
design
issue
is
how
registration
review
fits
in
with
other
activities
such
as
the
implementation
of
the
new
FQPA
safety
standard,

reregistration,
registration
of
new
uses,
and
tolerance
assessment
or
reassessment,
and
endocrine
disrupter
screening
and
testing.
In
what
way
could
EPA
integrate
these
activities
to
promote
the
efficiency
of
registration
review?

6.
Non­
conventional
pesticides.
Do
the
Agency's
proposed
goals,
objectives
and
procedures
for
registration
review
work
for
all
pesticides,
including
non­
conventional
pesticides
such
as
antimicrobial
or
biological
pesticides?
How
should
the
Agency's
concepts
be
modified
to
accommodate
any
special
issues
pertaining
to
the
registration
review
of
non­
conventional
pesticides?
DRAFT
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April
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2004
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55
7.
Criteria
for
setting
priorities
and
scheduling
compounds
for
review.
In
selecting
candidates
for
Registration
Review,
should
the
relative
risk,
length
of
time
since
its
last
review,
relationship
to
a
high
priority
initiative
(
for
example,
EPA's
current
initiative
on
persistent
bioaccumulative
toxics),
or
other
similar
programmatic
activities
(
e.
g.,
tolerance
reassessment
schedule)
be
considered?

What
additional
factors
should
the
agency
consider
in
selecting
and
prioritizing
pesticides
for
Registration
Review?

8.
Process
for
announcing
schedules
for
registration
review.
Should
the
agency
announce
its
registration
review
scheduling
priority
in
the
Federal
Register?
The
Agency
anticipates
announcing
tentative
schedules
5
years
in
advance
of
the
initiation
of
the
review.

Because
review
priorities
or
time
estimates
for
preparing
for
a
review
may
change
after
a
review
schedule
has
been
announced,
should
EPA
publish
updated
schedules,
and
if
so,
how
frequently?

9.
Scope
and
depth
of
registration
review.
Should
all
pesticides
undergo
the
same
level
of
review
or
should
the
review
be
tailored
to
the
level
of
risk
posed,
exposure
potential,
severity
of
hazard,
level
of
benefits,
degree
of
uncertainty,
length
of
time
since
its
last
review,
completeness
of
database
and
related
factors?

10.
Submission
of
applications
for
registration
review
by
registrants.
The
Agency
is
considering
requiring
a
registrant
to
submit
an
application
for
registration
review
of
its
pesticides.
The
application
could
follow
a
standard
format
and
content
and
include
any
required
data,
risk
mitigation
proposal
if
applicable,
information
on
use
and
usage
and
related
information.
Registrants
may
also
include
proposed
risk
assessments
as
part
of
their
submissions.
Do
you
believe
this
requirement
will
be
cost
effective
and
contribute
to
the
overall
efficiency
of
the
registration
review
program?
Should
EPA
require,
encourage,
or
discourage
the
preparation
of
proposed
risk
assessments
by
registrants?

11.
Potential
penalties
for
submission
of
incomplete
applications.
If
an
application
for
registration
review
is
  
material
required
to
be
submitted,''
the
product
registration
would
be
subject
to
cancellation
if
the
registrant
fails
to
comply
with
the
requirement.
If
a
registrant
fails
to
submit
required
data
as
specified
in
the
data
call­
in
notice
requiring
the
data,
the
product
registration
would
be
subject
to
suspension.
What
could
the
Agency
do
to
promote
compliance
with
a
requirement
to
submit
a
registration
review
application?
If
submission
of
an
application
for
registration
review
were
not
mandatory,
what
should
the
Agency
do
if
a
registrant
fails
to
submit
a
registration
review
application
or
submits
an
incomplete
application?

12.
Incentives
and
opportunities
for
registrant
participation
in
registration
review.
EPA
believes
that
the
public
may
benefit
when
a
registrant
takes
the
initiative
to
identify
and
provide
data
needed
for
refining
a
risk
assessment.
What
can
be
done
to
encourage
and
promote
voluntary
compliance
and
registrants
taking
the
initiative?
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April
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2004
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55
13.
Maximize
work
sharing
opportunities.
In
order
to
avoid
duplication
of
effort,
EPA
wishes
to
use
existing
reviews
wherever
possible,
provided
that
these
reviews
are
based
on
current
scientific
standards.
In
addition
to
its
own
recent
reviews,
EPA
could
use
data
reviews
prepared
by
state
or
foreign
governments
that
have
participated
in
harmonization
efforts.
Are
there
any
reasons
why
harmonized
data
reviews
should
not
be
used
in
registration
review?

14.
Public
participation.
EPA
envisions
public
participation
at
several
critical
junctures
of
the
registration
review
process.
How
can
the
public
have
access
to
sufficient
information
to
participate
meaningfully?
At
which
junctures
in
the
process
would
public
input
be
most
valuable?
Is
a
public
meeting
on
the
registrant's
data
and
associated
analyses
a
good
way
to
involve
stakeholders
in
the
registration
review
process?
If
not,
how
can
the
agency
best
involve
stakeholders?
Would
making
information
available
to
the
public
substantially
affect
any
stakeholder's
interests?
How
can
efficiencies
be
achieved?

15.
Role
of
the
Internet
in
involving
outside
stakeholders.
EPA
intends
to
publish
notices
in
the
Federal
Register
and
maintain
a
docket
for
registration
review
actions,
but
wants
to
expand
its
outreach
efforts.
Is
the
Internet
an
effective
supplement
to
the
published
notice
and
is
it
an
equitable
way
of
meaningfully
involving
stakeholders
in
the
registration
review
program?
What
other
opportunities
using
electronic
and
Internet
technology
should
the
Agency
consider?

16.
Participation
of
small
entities
in
the
rulemaking
process.
What
can
be
done
to
ensure
that
the
rulemaking
process
is
accessible
to
small
entities
and
that
the
Agency
identifies
issues
of
concern
to
small
entities
regarding
procedures
for
registration
review?

IX.
Do
Any
of
the
Regulatory
Assessment
Requirements
Apply
to
this
Action?

The
Office
of
Management
and
Budget
(
OMB)
has
determined
that
this
advanced
notice
of
proposed
rulemaking
is
not
a
  
significant
regulatory
action''
subject
to
review
by
OMB
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,

1993).
Nevertheless,
the
Agency
provided
OMB
with
an
opportunity
to
review
a
draft
of
this
advanced
notice
of
proposed
rulemaking,
and
did
not
receive
any
comments
that
resulted
in
changes
to
this
document.

This
advanced
notice
of
proposed
rulemaking
does
not
impose
any
requirements.
Instead,
it
seeks
comments
and
suggestions
on
possible
approaches
that
the
Agency
should
consider
in
developing
a
procedural
rulemaking
to
implement
the
registration
review
requirements
contained
DRAFT
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April
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2004
Page
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55
in
FIFRA
section
3(
g).
As
such,
the
various
other
regulatory
assessment
requirements
that
apply
when
an
agency
imposes
requirements
do
not
apply
to
this
advance
notice
of
proposed
rulemaking.

As
a
part
of
your
comments
on
this
document,
you
may
include
any
comments
or
information
that
you
have
regarding
these
requirements.
In
particular,
any
comments
or
information
that
would
facilitate
the
Agency's
assessment
of
the
potential
impact
of
a
procedural
rule
on
small
entities
pursuant
to
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.);
the
Agency's
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104­
113,
section
12(
d)
(
15
U.
S.
C.
272
note);
and
the
Agency's
consideration
of
environmental
health
or
safety
effects
on
children
pursuant
to
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
The
Agency
will
consider
such
comments
during
the
development
of
the
procedural
rulemaking
as
it
takes
appropriate
steps
to
address
any
applicable
requirements.

List
of
Subjects
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping.

Dated:
April
19,
2000.

Carol
M.
Browner,

Administrator.

[
FR
Doc.
00­
10433
Filed
4­
25­
00;
8:
45
am]

BILLING
CODE
6560­
50­
F
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ATTACHMENT
G
Estimating
the
Potential
Paperwork
Burden
and
Cost
for
DCIs
The
following
is
a
general
description
of
the
methodology
used
by
the
Agency
to
estimate
the
potential
paperwork
burden
and
costs
for
respondents
to
comply
with
data
call­
ins
(
DCIs)
issued
by
EPA.
In
general,
the
ICRs
provided
an
estimate
of
the
potential
paperwork
burden
and
costs
related
to
a
typical
or
general
DCI
based
on
sample
DCIs
derived
from
previously
issued
DCIs.
Prior
to
issuing
a
specific
DCI,
pursuant
to
the
terms
of
clearance
for
the
ICRs,
EPA
calculated
the
paperwork
burden
and
costs
related
to
the
specific
DCI
using
the
general
method
described
here.

The
estimates
represent
the
burden
associated
with
completing
multi­
year
studies
and
submitting
the
study
results
to
EPA
in
response
to
a
DCI.
A
portion
of
the
total
cost
for
a
study
conducted
in
response
to
a
DCI
may
be
attributed
to
the
paperwork
related
requirements
that
EPA
imposes
on
the
pesticide
registrants.
The
potential
number
of
DCIs
that
might
be
issued
in
any
year,
the
type
of
data
requested,
and
the
number
of
respondents
potentially
affected
by
a
particular
DCI
vary,
and
remain
unknown
until
the
Agency
identifies
the
need
for
the
information.
To
help
estimate
potential
burden
under
these
circumstances,
EPA
reviewed
previously
issued
DCIs
to
develop
sample
DCIs
that
are
used
to
generate
burden
and
cost
estimates
for
the
anticipated
testing
that
would
be
requested
by
EPA,
from
which
EPA
also
calculates
the
paperwork
burden
and
costs.

1.
What
activities
are
included
in
the
estimated
paperwork
burden
and
cost
for
DCIs?

Under
the
Paperwork
Reduction
Act
(
PRA)
,
44
USC
3501
et
seq.,
and
the
implementing
regulations
at
5
CFR
1320
et
seq.,

"
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
typically
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.

In
the
case
of
DCIs,
a
responding
registrant
may
be
required
to
engage
in
one
or
more
of
the
following
paperwork
related
activities:
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1)
Read
DCI
&
test
requirements
(
includes
review
of
records
for
previously
unavailable
data
&
requesting
exemptions
or
waivers)

2)
Discuss
test
and
protocol
with
Agency,
submit
exemption/
waiver
request
3)
Plan
activities
necessary
to
respond
to
DCI
4)
Create
&
gather
information
(
conduct
tests)

5)
Process,
compile,
review
information
for
accuracy
6)
Complete
written
forms
7)
Submit
information
to
EPA
8)
Store,
file,
or
maintain
information
OPP
will
only
issue
a
DCI
for
a
pesticide
chemical
after
it
reviews
the
available
data
and
determines
that
the
available
information
is
not
sufficient
to
satisfy
the
statutory
requirements
for
reregistration.
Although
the
Agency
is
responsible
for
identifying
available
data,
the
registrant
may
have
data
that
is
not
generally
available.
In
such
a
case,
the
registrant
may
respond
to
a
DCI
by
simply
submitting
such
data
to
EPA.
In
addition,
even
after
OPP
has
completed
its
review
and
has
determined
that
additional
data
must
be
called­
in,
registrants
may
also
request
a
waiver
if
they
believe
that
OPP
can
properly
evaluate
the
risks
of
their
pesticide
chemicals
without
additional
data.
OPP
will
review
each
waiver
request
individually.
For
purposes
of
estimating
the
potential
paperwork
burden
and
costs,
EPA
assumes
that
registrants
do
not
have
any
such
data,
and
that
registrants
will
not
request
any
waivers.
Since
such
activities
are
likely
to
be
few,
the
estimates
provided
will
cover
these
activities
and
will
generally
result
in
an
overestimate
of
the
total
burden
and
costs
if
these
activities
occur
for
any
specific
DCI.

2.
How
did
EPA
estimate
the
potential
Respondent
paperwork
burden?

In
general,
the
estimates
for
the
total
burden
and
costs
associated
with
a
Pesticide
Registrant
responding
to
a
DCI
are
derived
from
the
total
costs
for
doing
the
tests
that
might
be
required
based
on
the
sample
DCIs.
The
average
potential
test
costs
were
derived
using
cost
information
for
individual
DCIs
previously
issued
by
the
Agency.
Based
on
the
cost
information
available,
the
Agency
calculates
an
average
total
test
cost
for
the
sample
DCIs.
These
costs
then
form
the
basis
for
calculating
the
labor
costs
from
which
the
burden
hours
are
derived.

Although
the
Agency
also
anticipates
that
multiple
respondents
for
a
given
chemical
will
often
establish
consortiums
to
share
in
the
burden
of
generating
the
data
and
that
the
burden
and
cost
will
be
distributed
proportionately
across
the
participating
members.

However,
for
purposes
of
this
ICR,
EPA
estimates
are
on
a
per
Registrant
basis,
without
considering
this
possibility
for
sharing
the
burden.
The
Agency
did
not
make
any
adjustments
to
consider
reductions
related
to
such
cost
sharing.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
51
of
55
The
total
annual
respondent
paperwork
burden
for
this
ICR
is
estimated
to
be
64,699
hours.
The
total
annual
burden
hours
estimate
is
for
no
more
than
61
responses
(
1
for
Special
Review
and
60
for
Registration
Review)
to
comply
with
planned
data
call­
ins
(
DCIs).
The
average
annual
paperwork
burden
is
estimated
to
be
919
hours
(
919
hours
per
response
x
1
response
per
year)
for
Special
Review
and
63,780
hours
(
1,063
hours
per
response
x
60
responses
per
year)
for
Registration
Review.
The
919
hours
per
Special
Review
response
and
1,063
hours
per
Registration
Review
response
are
the
same
as
given
in
the
previous
ICR.
Tables
1A
and
1B
present
the
expected
labor
mix
required
and
breakdown
of
the
per
respondent
collection
activities
based
on
the
Special
Review
DCIs,
taken
from
the
existing
ICR.
An
overview
of
these
respondent
burden
hour
estimates
is
presented
in
Table
3,
along
with
cost
estimates.
The
scope
of
the
existing
ICR
is
focused
primarily
on
the
anticipated
burden
necessary
to
comply
with
Agency
DCIs
in
support
of
the
Special
Review
Program
to
collect
and
evaluate
information
regarding
pesticides
suspected
of
presenting
risks
to
human
health
or
the
environment
and
the
Registration
Program
to
collect
and
evaluate
information
regarding
review
of
a
pesticide's
registration
on
a
15­
year
cycle.

Two
types
of
burdens
on
respondents
were
considered
in
deriving
the
burden
estimates
for
the
existing
ICR:
Administrative
Burden
and
Technical
Burden.
The
respondents'
Administrative
Burden
is
defined
as
the
time
spent
communicating
and
working
with
the
Agency
throughout
the
Special
Review
process
to
develop
and
agree
upon
data
requirements
such
as
the
protocol,
the
field
site,
and
data
presentations.
In
addition,
the
Administrative
Burden
includes
the
time
for
registrants
to
draft
and
summarize
the
results
of
studies
completed
by
an
individual
respondent
or
by
a
consortium
of
respondents
for
one
chemical.
The
Administrative
Burden
is
also
intended
to
include
time
spent
overseeing
any
contractor
activities
employed
by
the
respondent.
The
Technical
Burden
represents
the
labor
needed
to
actually
derive
the
data,
which
involves
designing
the
test,
performing
it,
analyzing
and
compiling
test
data
and
summarizing
the
results.

Estimates
for
the
total
hours
associated
with
both
types
of
respondent
burdens
are
derived
from
the
total
test
costs.
The
Agency
anticipates
that
multiple
respondents
for
a
given
chemical
will
establish
consortiums
to
share
in
the
burden
of
generating
the
data
and
that
the
burden
and
cost
will
be
distributed
proportionately
across
the
participating
members.

To
derive
the
Administrative
Burden,
the
Agency
estimated
the
amount
of
administrative
labor
cost
as
a
percentage
of
the
total
test
costs.
The
Agency
assumed
that
respondents
would
expend
approximately
two
percent
of
the
total
cost
for
Administrative
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
1This
percentage
represents
an
estimate
obtained
from
expert
opinion,
industry
sources,
and
proprietary
data.

2This
estimate
was
derived
from
a
survey
of
the
test
data
cost
estimates
by
DPRA,
Inc.;
subcontract
with
W.
R.
Landis
Associates,

Inc.
3The
hourly
rates
are
based
on
EPA's
1993
RIA
supporting
the
proposed
plant
pesticide
rule
(
published
in
the
Federal
Register,
of
March
28,
1994,
indexed
to
1996
dollars.

4
Same
as
Footnote
2.
Page
52
of
55
Burden.
1
The
Agency
assumed
that
the
value
of
this
time
is
divided
proportionally
among
management
(
20%),
technical
staff
(
65%)

and
clerical
(
15%).
2
The
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
130,
$
88,
and
$
40,
respectively.
3
The
hourly
rate
includes
overhead
and
benefits.
The
combination
of
the
proportional
distribution
of
cost
across
the
labor
mix
and
the
hourly
rate
for
the
labor
categories
are
then
used
to
determine
the
total
burden
hours
from
the
total
labor
cost
estimate.

To
derive
the
Technical
Burden,
the
Agency
assumes
that
one­
third
of
the
total
test
cost
represents
labor.
4
Management,

technical,
and
clerical
comprise
the
labor
staff.
The
same
proportional
labor
rate
approximations
and
hourly
rates
are
used
to
calculate
the
distribution
of
hours
across
the
labor
mix
from
the
total
labor
cost
estimate.
The
technical
burden
related
to
the
paperwork
activities,
i.
e.,
the
labor
burden,
is
included
in
the
burden
and
cost
estimates
for
this
ICR.
Not
included
is
the
portion
of
the
test
costs
associated
with
the
non­
paperwork
related
activities
that
anyone
would
typically
undertake
as
part
of
conducting
any
study,
and
which
are
not
related
to
any
requirement
imposed
by
EPA
as
part
of
the
DC,
e.
g.,
daily
care
and
feeding
of
test
animals,

cleaning
of
cages,
etc.

3.
Estimating
the
Respondent
Paperwork
Cost
The
total
annual
respondent
paperwork
cost
for
this
ICR
is
estimated
to
be
$
5,851,894.
Over
a
three­
year
ICR
approval
period
for
this
ICR,
the
total
respondent
cost
is
estimated
to
be
$
17,555,682.
Tables
1A
and
1B
present
the
expected
labor
mix
required
and
a
breakdown
of
the
collection
activities
per
respondent
as
provided
in
the
existing
ICR.
An
overview
of
these
cost
estimates
is
presented
in
Table
3,
along
with
burden
hour
estimates.

Tables
1A
and
1B
show
that
for
Special
Review
and
Registration
Review,
the
distributions
of
respondent
burden
hours
of
management,
technical,
and
clerical
sources
among
the
various
collection
activities
are
the
same
as
given
in
the
previous
ICR.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
5Same
as
Footnote
1.

6Same
as
Footnote
2.

7Ibid.
8Same
as
Footnote
3.
Page
53
of
55
Therefore,
the
respondent
burden
totals
of
919
hours
per
Special
Review
response
and
1,063
hours
per
Registration
Review
response
are
also
the
same
as
that
found
in
the
previous
ICR.
Using
these
burden
hours
with
updated
labor
rates,
the
Agency
derived
the
cost
burdens
for
a
Special
Review
response
and
a
Registration
Review
response
in
this
ICR.

As
was
the
case
for
the
burden
hour
analysis
for
the
Special
Review
and
Registration
Review
DCIs,
two
types
of
costs
to
respondents
are
considered
for
developing
the
cost
associated
with
this
ICR:
Administrative
Cost
and
Technical
Cost.
The
definitions
of
these
costs
are
the
same
as
those
defined
for
the
burden
hours
with
the
exception
that
they
are
costs
not
hours.
The
assumption
is
that
the
respondent
would
expend
approximately
two
percent
of
the
total
test
cost
for
the
Administrative
Burden5;
the
Technical
Burden
is
based
on
the
assumption
that
one­
third
of
the
total
test
cost
represents
labor
cost6;
the
value
of
labor
is
divided
proportionally
among
management
(
20%),
technical
staff
(
65%)
and
clerical
(
15%).
7
The
value
of
labor
per
hour
for
management,

technical,
and
clerical
is
$
130,
$
88,
and
$
40,
respectively.
8
The
Agency
anticipates
that
multiple
respondents
for
a
given
chemical
could
establish
consortiums
to
share
in
the
burden
of
generating
the
data
and
that
the
burden
and
cost
may
be
distributed
proportionately
across
such
participating
members.
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
54
of
55
ATTACHMENT
H
Display
Related
to
OMB
Control
#
2070­
0057
­
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
Registration
Standards
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
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.
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.
.
.
.
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.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
155.30
Data
Requirements
for
Registration
.
.
.
.
.
.
.
.
.
.
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.
.
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.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
158.30
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
158.32
.
.
.
.
.
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.
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.
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.
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.
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.
.
.
.
.
.
.
.
.
.
.
158.34
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
158.45
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
158.75
.
.
.
.
.
.
.
.
.
.
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.
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.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
158.101
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
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.
.
.
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.
.
.
.
.
.
.
.
.
.
.
158.155
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
158.160
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
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.
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.
.
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.
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.
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.
.
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.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
158.162
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
158.165
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
158.167
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
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158.170
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158.175
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158.180
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158.190
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.
158.240
.
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.
158.290
.
.
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.
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.
158.340
DRAFT
FOR
PUBLIC
COMMENT
April
12,
2004
Page
55
of
55
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158.390
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158.440
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158.490
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158.540
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.
158.590
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158.640
.
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.
158.690
.
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.
158.740
Good
Laboratory
Practice
Standards
.
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Part
160