Document ID: EPA-HQ-OPP-2004-0110-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-05-24T04:00Z

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SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a).
Title
of
the
Information
Collection:
Data
Generation
for
Pesticide
Reregistration
OMB
#:
2070­
0107
EPA
#:
1504.05
1
(
b).
Short
Characterization/
Abstract
This
is
a
request
to
renew
the
existing
information
collection
request
(
ICR)
for
the
ICR
entitled:
Data
Generation
for
Pesticide
Reregistration
(
OMB
No.
2070­
0107;
EPA
No.
1504.05).
This
information
collection
is
designed
to
provide
the
Environmental
Protection
Agency
(
EPA,
the
Agency)
with
the
necessary
data
for
all
pesticide
active
ingredients
originally
registered
before
November
1,
1984,
to
determine
whether
each
pesticide's
use
poses
unreasonable
risks
to
human
health
or
the
environment.
Pursuant
to
section
4
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended,
EPA
must
assess
health
and
safety
data
for
these
active
pesticide
ingredients.
Section
4
of
FIFRA
also
establishes
a
process
for
the
development
of
information
needed
to
make
reregistration
decisions.
Pesticide
registrants
seeking
reregistration
must
generate
and
report
the
required
data
according
to
specific
time
tables.

This
information
collection
activity
allows
EPA's
Office
of
Pesticide
Programs
(
OPP)
to
obtain
data
needed
by
OPP
scientists
to
assess
and
characterize
pesticide
risks,
and
for
risk
managers
to
determine
whether
and
under
what
conditions
pesticides
may
be
reregistered
and
reassess
existing
tolerances
to
ensure
that
they
meet
the
standards
established
by
law.
Data
collected
may
consist
of
toxicology
studies,
residue
chemistry
studies,
fish
and
wildlife
studies,
environmental
fate
studies,
or
other
data
needed
to
analyze
the
potential
risks
associated
with
pesticide
chemicals
and
products.
This
collection
also
supports
the
Agency's
reassessment
of
food
tolerances
associated
with
reregistration.

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a).
Need/
Authority
for
the
Collection
EPA
implements
the
reregistration
program
pursuant
to
the
authority
in
section
4
of
FIFRA,
as
amended,
see
Attachment
A.
EPA
is
required
to
collect
additional
information,
as
necessary,
to
determine
whether
active
pesticide
ingredients
initially
registered
before
November
1,
1984,
are
eligible
for
reregistration.

2(
b).
Practical
Utility/
Users
of
the
Data
Under
the
FIFRA
section
4
reregistration
program,
EPA
examines
health
and
safety
data
for
pesticide
active
ingredients
initially
registered
before
November
1,
1984,
and
determines
whether
they
are
eligible
for
reregistration.
To
be
eligible,
a
pesticide
must
have
a
substantially
complete
set
of
data,
and
the
Agency
must
assess
all
the
information/
data
necessary
to
determine
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whether
products
containing
the
pesticide
present
unreasonable
risks
to
man
or
the
environment
when
used
in
accordance
with
approved
label
directions.

In
conducting
the
reregistration
program,
when
the
need
for
additional
information
or
data
arises,
the
Office
of
Pesticide
Programs
(
OPP)
is
authorized
to
issue
a
data
call­
in
notice
(
DCI)
pursuant
to
FIFRA
section
3(
c)(
2)(
B)
(
Attachment
B)
to
obtain
the
data,
and
when
necessary,
the
registrant
may
be
required
to
certify
compliance
with
data
compensation
requirements
under
the
authority
of
FIFRA
section
3(
c)(
2)(
D).
Agency
scientists
and
analysts
integrate
the
new
data
received
from
registrants
with
the
existing
data
in
EPA's
files.
EPA
reviews
all
relevant
information
to
assess
the
potential
risks
associated
with
the
use
of
the
pesticide,
to
determine
whether
the
pesticide
should
be
reregistered.
If
a
determination
is
made
that
a
pesticide
is
eligible
for
reregistration,
and
the
registrant
submits
acceptable
product­
specific
data
and
revised
labeling,
products
containing
the
pesticide
shall
be
reregistered
within
a
specified
time
period.
However,
if
after
a
review
of
the
data,
it
is
determined
that
a
pesticide
should
not
be
reregistered,
the
Agency
will
take
appropriate
regulatory
action.

To
complete
a
pesticide's
data
base
for
reregistration,
registrants
have
been
required
to
generate
additional
information
on
human
health
and
environmental
effects,
beyond
the
information
that
was
submitted
to
the
Agency
when
a
pesticide
was
first
registered.
Prior
to
1984,
only
acute
testing
or
short­
term
environmental
testing
was
required
for
many
pesticides
before
registration.
However,
by
1984,
EPA
had
determined
that
data
on
chronic
health
effects
and
long­
term
environmental
effects
(
e.
g.,
tests
for
carcinogenicity
or
mutagenicity,
or
life
cycle
tests
of
organisms
exposed
to
a
pesticide)
are
necessary
in
many
cases,
and
issued
updated
data
requirements
for
registration.
Any
unfulfilled
data
requirements,
or
data
gaps,
are
filled
during
reregistration.

In
addition,
all
registered
pesticides
which
may
occur
in
food
must
meet
the
safety
standard
of
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA)
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
FQPA
directs
the
Agency
to
consider
aggregate
exposures
from
dietary
and
other
non­
occupational
sources
when
assessing
the
risks
of
a
pesticide.
In
addition
to
dietary
exposure,
such
sources
as
drinking
water
and
residential
use
must
be
considered.
In
evaluating
pesticides
for
reregistration,
EPA
must
make
the
statutory
determination
that
pesticide
residues
in
food
or
feed
will
result
in
a
reasonable
certainty
of
no
harm
to
human
health
from
aggregate
exposure
through
dietary,
non­
occupational,
and
drinking
water
routes
of
exposure.
FQPA
also
directs
EPA
to
consider
the
cumulative
effects
of
pesticides
that
share
a
"
common
mechanism
of
toxicity,"
consider
special
sensitivities
of
infants
and
children,
and
consider
possible
endocrine
disruptor
effects.

FQPA
requires
the
Agency
to
reassess
all
existing
tolerances
(
maximum
limits
for
pesticide
residues
in
food
or
feed)
by
2006,
to
ensure
that
they
meet
the
safety
standard
of
the
law.
EPA
was
directed
to
give
priority
to
the
review
of
those
pesticides
that
appear
to
pose
the
greatest
risk
to
public
health,
and
to
reassess
33%
of
the
over
9,700
tolerances
requiring
reassessment
within
three
years
(
by
August
3,
1999),
66%
within
six
years
(
by
August
3,
2002),
and
100%
in
10
years
(
by
August
3,
2006).
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EPA
is
meeting
the
tolerance
reassessment
requirements
to
a
great
extent
through
the
reregistration
program.
Schedules
have
been
coordinated
and
integrated
so
that,
in
the
course
of
making
reregistration
eligibility
decisions,
the
Agency
also
is
completing
much
of
the
tolerance
reassessment.
EPA
also
is
completing
tolerance
reassessment
through
the
pesticide
registration
program.
As
applications
to
register
new
food
uses
of
existing
pesticides
are
received,
EPA
must
reassess
the
existing
tolerances
as
well
as
the
proposed
new
tolerances,
to
make
sure
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
public
from
aggregate
exposure
to
residues
from
all
uses.
Finally,
EPA
is
revoking
tolerances
for
pesticide
uses
that
have
been
canceled,
many
as
a
result
of
reregistration.
Through
these
three
types
of
tolerance
reassessment
decisions,
the
Agency
is
completing
tolerance
reassessment
within
the
time
frames
mandated
by
the
law.
During
the
summer
of
2002,
for
example,
EPA
surpassed
the
second
portion
of
the
FQPA
goal
by
reassessing
66%
of
all
food
tolerances
(
by
August
3,
2002).

EPA
expects
to
complete
the
integrated
tolerance
reassessment
and
reregistration
programs
within
approximately
the
same
time
period,
that
is,
in
2006
and
2008
respectively.
By
then,
transition
to
the
new
registration
review
program
mandated
by
FQPA
which
requires
reevaluation
of
every
existing
registered
pesticide
with
the
goal
of
a
15­
year
cycle
will
be
underway.

A
record
of
each
study
submitted
to
OPP
in
support
of
pesticide
registration
or
reregistration
is
maintained
in
the
Agency's
Pesticide
Document
Management
System
(
PDMS).
The
public
may
access
the
PDMS
bibliography
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
studies
that
are
non­
confidential,
through
a
Freedom
of
Information
Act
(
FOIA)
request.

2(
c).
Process
and
Program
Status
Section
4
of
FIFRA
mandates
reregistration
of
all
pesticides
registered
before
November
1,
1984.
FIFRA,
as
amended
by
FQPA
in
1996,
authorizes
funding
for
the
reregistration
program
through
2002.
The
Pesticide
Registration
Improvement
Act
(
PRIA)
of
2003
requires
all
food
use
Reregistration
Eligibility
Decisions
(
REDs)
and
non­
food
use
REDs
be
completed
in
2006
and
2008,
respectively.
FIFRA
structured
the
reregistration
process
into
five
phases
with
mandated
deadlines
for
the
Agency
and
pesticide
producers
or
"
registrants."

Phase
1,
List
Active
Ingredients.
FIFRA
directs
EPA
to
create
a
list
of
the
active
ingredients
used
in
pesticides
registered
before
November
1,
1984,
and
requested
pesticide
registrants
to
notify
EPA
of
the
intent
to
seek
reregistration.
In
1989,
EPA
created
and
published
a
list
that
is
divided
into
four
categories,
Lists
A
through
D.

Phase
2,
Declare
Intent
and
Identify
Studies.
This
phase
required
pesticide
registrants
to
notify
EPA
whether
or
not
they
intended
to
reregister
their
products;
to
identify
and
commit
to
providing
the
necessary
studies,
including
either
making
a
generic
data
exemption
claim
or
commitment
to
generate
or
share
data;
and
to
pay
the
first
installment
of
the
reregistration
fee.
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During
this
phase,
EPA
issued
guidance
for
registrants
to
assist
them
in
preparing
Phase
2
and
Phase
3
responses.
Phase
2
was
completed
in
1990.

Phase
3,
Summarize
Studies.
This
phase
required
registrants
to
submit
summaries
and
reformat
acceptable
studies,
"
flag"
studies
indicating
adverse
effects,
re­
commit
to
satisfying
all
applicable
data
requirements,
and
pay
the
final
installment
of
the
reregistration
fee.
Phase
3
was
completed
in
1990.

Phase
4,
EPA
Review
and
Data­
Call­
In.
During
Phase
4,
EPA
reviewed
all
data
submitted
in
Phase
2
and
Phase
3
and
required
registrants
to
meet
any
unsatisfactory
data
requirements
within
four
years.
This
phase
was
completed
in
1993.

Phase
5,
Reregistration
Decisions.
Currently,
EPA
is
implementing
Phase
5
of
the
Reregistration
Program.
In
this
final
stage,
the
Agency
is
actively
reviewing
the
studies
submitted
for
each
pesticide
and
determining
whether
or
not
the
pesticide
is
eligible
for
reregistration
 
that
is,
whether
the
data
base
is
substantially
complete,
and
the
pesticide
does
not
cause
unreasonable
adverse
effects
to
people
or
the
environment
when
used
in
accordance
with
approved
labeling.
Under
FFDCA,
as
amended
by
FQPA,
EPA
also
is
reassessing
tolerances
for
any
food
uses,
and
considering
whether
the
pesticide
meets
the
safety
standard
of
the
new
law.
The
Agency
summarizes
its
resulting
risk
management/
regulatory
decision
about
the
pesticide
in
a
Reregistration
Eligibility
Decision
(
RED)
document.
With
the
RED,
EPA
calls
in
productspecific
data
and
revised
labeling.
About
two
years
later,
after
this
additional
data
is
received
and
reviewed
(
and
if
all
the
active
ingredients
in
a
product
are
eligible),
product
reregistration
may
be
completed.

EPA
completed
the
process
of
calling
in
the
generic
studies
required
for
pesticides
in
reregistration
to
fill
any
then­
existing
data
gaps
during
Phase
4.
Since
that
time,
the
basic
generic
data
set
for
most
pesticides
has
been
developed
by
their
registrants
and
submitted
to
EPA.
The
studies
submitted
either
are
under
review
by
Agency
scientists
to
determine
whether
they
are
acceptable,
or
have
been
reviewed
and,
if
found
acceptable,
are
being
used
to
support
risk
assessments,
risk
management
conclusions,
and
reregistration
decisions.

Although
the
Phase
4
data
call­
ins
are
completed,
other
data
collection
and
review
activities
for
pesticides
in
reregistration
and
tolerance
reassessment
will
continue
to
be
necessary
until
these
programs
are
concluded.
The
data
that
EPA
must
continue
to
collect
and
review
fall
into
three
general
categories:
confirmatory
data,
voluntary
data,
and
product­
specific
data.

Confirmatory
Data.
In
completing
a
RED,
additional
generic
studies
sometimes
are
required
to
confirm
the
Agency's
risk
assessments,
findings,
or
conclusions
about
a
pesticide,
and
to
help
determine
whether
further
use
modifications
will
be
necessary
to
reduce
risks
of
concern.

Voluntary
Data.
FQPA,
which
became
effective
upon
its
enactment
on
August
3,
1996,
requires
EPA
to
specifically
consider
a
number
of
new
factors
when
making
pesticide
reregistration
and
other
types
of
regulatory
decisions.
On
January
31,
1997,
EPA
issued
Pesticide
Registration
(
PR)
Notice
97­
1
identifying
areas
in
which
the
Agency
may
need
additional
data
to
fully
assess
risks
under
FQPA.
The
notice
encouraged
registrants
to
supplement
their
original
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reregistration
submissions
with
additional
information
that
may
permit
more
accurate
estimates
of
exposure
and/
or
risk.
As
a
result
of
PR
Notice
97­
1,
EPA
is
receiving
voluntarily
submitted
studies
for
pesticides
in
reregistration,
particularly
for
large
volume,
controversial
chemicals.

Product­
Specific
Data.
After
the
generic
data
supporting
a
pesticide
are
evaluated
and
the
RED
is
developed
and
issued,
EPA's
focus
turns
to
the
information
and
data
required
to
make
reregistration
decisions
at
the
product­
specific
level.
For
every
end­
use
product
covered
by
a
RED
(
that
is,
every
product
that
contains
an
active
ingredient
included
in
the
RED),
the
Agency
requires
the
submission
of
a
Confidential
Statement
of
Formula,
certain
data
on
the
product
as
formulated
and
sold
(
including
acute
toxicity
and
product
chemistry
studies),
and
revised
labeling.
Such
information
and
data
are
essential
to
making
the
final
product
reregistration
decision.

Since
a
need
still
exists
to
collect
the
information
necessary
to
complete
the
pesticide
reregistration
program,
EPA
is
renewing
this
ICR
for
another
three
years.
The
renewal
of
this
ICR
will
also
allow
for
the
continued
use
of
the
forms
associated
with
this
ICR;
e.
g.,
EPA
Data
Call­
In
Response
Form
(
Attachment
C);
EPA
Requirements
Status
and
Registrant's
Response
Form
(
Attachment
D);
Certification
of
Attempt
to
Enter
into
an
Agreement
with
Registrants
for
Development
of
Data
form
(
EPA
Form
8570­
32,
Attachment
E);
and
Certification
with
Respect
to
Citation
of
Data
(
EPA
Form
8570­
34,
Attachment
F).

Please
note
that
this
information
collection
program
is
separate
from
the
information
collection
program
described
in
the
ICR
entitled
"
Data
Call
in
for
Special
Review
Chemicals
and
Registration
Review
Program"
(
EPA
ICR
#
922,
OMB#
2070­
0057)
implemented
pursuant
to
section
3(
g)
of
FIFRA.
The
Registration
Review
Program
involves
the
review
of
all
pesticide
registrations
with
the
goal
of
a
15­
year
cycle.
Similar
to
the
FIFRA
section
4
reregistration
program,
the
Registration
Review
Program
directs
EPA
to
use
the
authority
in
FIFRA
section
3(
c)(
2)((
B)
to
require
pesticide
registrants
to
generate
and
submit
data
to
the
Agency
where
such
data
are
needed
to
assess
whether
registration
of
an
existing
pesticide
poses
unreasonable
risk
to
man
or
the
environment.
By
the
time
the
reregistration
program,
currently
in
its
final
years,
is
completed,
the
new
section
3(
g)
Registration
Review
Program
should
be
fully
implemented.

3.
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a).
Non­
duplication
OPP
has
made
concerted
efforts
to
avoid
duplication
and
promote
efficiency
in
information
collection
procedures.
For
example,
registrants
were
provided
guidance
to
help
them
identify
generic
studies
that
had
been
previously
submitted
to
the
Agency
but
did
not
meet
current
requirements
for
reregistration.
Rejection
Rate
Analyses
examining
studies
submitted
to
the
Agency
under
various
scientific
disciplines
were
developed
and
issued
by
OPP,
to
provide
guidance
to
registrants.
These
analyses
assisted
registrants
in
developing
studies
that
met
Agency
criteria
and
were
more
likely
to
be
accepted
for
review
when
initially
submitted.
This
guidance
enabled
registrants
to
initiate
any
new
studies
required
for
reregistration
as
soon
as
possible
and
avoid
submitting
deficient
data.
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The
Agency
allows
cost­
sharing
agreements
among
manufacturers
of
specific
pesticide
chemicals
to
minimize
the
duplication
of
laboratory
tests
conducted
for
this
collection.
Data
callin
notices
explain
the
statutory
provisions
for
cost
sharing
agreements
for
FIFRA.

Finally,
the
information
called
in
is
specific
to
the
needs
of
the
federal
pesticide
law,
negating
the
need
for
similar
data
by
other
federal
agencies.
The
Agency
maintains
files
on
all
pesticide
chemicals,
which
includes
all
correspondence
and
information/
data
submitted.
Before
any
DCI
is
issued,
these
files
are
referenced
to
determine
whether
the
necessary
data
are
already
on
hand,
thereby
eliminating
duplicative
data
requests.

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
Congress
intended
the
reregistration
provisions
of
FIFRA
to
include
ongoing
consultations
with
registrants
concerning
data
requirements
for
reregistration.
OPP
is
constantly
consulting
with
the
registrants
regarding
data
needs
as
new
technology
evolves.

The
initial
stage
of
the
reregistration
process
allows
the
registrant
to
give
feedback
to
the
Agency's
request
for
data.
OPP
is
always
open
to
communications
with
registrants
concerning
any
issues
they
may
have
with
the
requirements
for
data.
Additionally,
registrants
may
request
waivers
of
information
requirements
if
they
believe
that
the
Agency
can
properly
evaluate
their
pesticide
without
additional
data.

3(
d).
Effects
of
Less
Frequent
Collection
Information
is
collected
under
this
activity
only
once
and
only
when
specific
data
are
required.

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.
EPA
requirements
in
40
CFR
169.2(
k)
state
that
records
containing
research
data
relating
to
registered
pesticides
be
retained
for
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.

3(
f).
Confidentiality
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In
general,
most
health
and
safety
data
submitted
by
registrants
under
FIFRA
are
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
must
be
kept
in
secure
(
double­
locked)
areas,
and
all
CBI
intended
to
be
destroyed
must
be
cleared
by
a
document
control
officer
and
shredded.

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

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a).
Respondents/
NAICS
Codes
EPA
requires
registrants
of
pesticide
products
to
submit
data
to
support
reregistration
of
their
product.
The
registrants
are
responsible
for
producing
and
maintaining
data
to
support
their
registrations,
and
therefore,
are
the
only
entities
affected
by
this
collection
activity.
The
North
American
Industrial
Classification
System
(
NAICS)
code
for
respondents
to
this
ICR
is
325320
(
Pesticide
and
other
Agricultural
Chemical
Manufacturing).

4(
b).
Information
Requested
(
i)
Data
items,
including
record
keeping
requirements
The
types
of
data
that
may
be
requested
by
this
ICR
will
depend
on
the
information
that
is
missing
in
the
current
set
of
data
that
is
available
to
EPA
for
the
pesticide
chemical.
However,
the
types
of
data
that
can
be
the
subject
of
a
generic
data
call­
in,
or
be
called
in
as
confirmatory
data,
or
called
in
for
product­
specific
studies
required
at
the
end
of
the
reregistration
process,
or
needed
to
support
individual
end­
use
product
reregistration
are
categorized
and
listed
in
40
CFR
Part
158,
as
well
as
on
EPA's
Internet
Home
page
and
in
other
guidance
for
registering
a
pesticide.
These
categories
include:

Product
Chemistry
Residue
Chemistry
Environmental
Fate
Toxicology
Reentry
Protection
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Spray
Drift
Wildlife
and
Aquatic
Organisms
Plant
Protection
Nontarget
Insect
Product
Performance
Biochemical
Pesticides
Microbial
Pesticides
Additional
types
of
data
may
be
useful
to
support
tolerance
reassessment
under
FQPA.
Currently,
many
of
these
studies
are
being
submitted
by
pesticide
registrants
on
a
voluntary
basis.
Some
examples
of
these
types
of
studies
include:

Exposure
Studies
Dermal
Absorption/
Penetration
Studies
Acute
and
Subchronic
Neurotoxicity
Studies
Cholinesterase
Determination
Biomonitoring
Studies
(
in
Children)
Food/
Milk
Market
Basket
Surveys
Monte
Carlo
Probabilistic
Assessments/
Acute
and
Chronic
Dietary
Exposure
Analyses
Historical
Water
Monitoring
Data
Field
Monitoring
Studies
and
Evaluations
Runoff
and
Drift
Monitoring
Studies
Pesticide
Removal
Studies
using
Vegetative
Filter
Strips
Retrospective
Analyses
of
Surface
Water
Contamination
Analyses
of
Use
Patterns
Research
Studies
of
Applications
and
Use
in
Professional
Markets
Comparative
Formulations/
Application
Methods/
Resulting
Crop
Residue
Studies
Mechanistic
Studies
for
Carcinogenicity
Studies
on
Potential
to
React
with
DNA
In
addition
to
these
types
of
data,
other
special
studies
could
be
required
to
support
reregistration.
These
studies
would
be
based
on
the
particular
characteristics
of
the
chemical.

OPP
will
issue
a
data
call­
in
for
a
pesticide
chemical
only
after
it
reviews
the
available
data
and
determines
that
the
information
is
not
sufficient
to
satisfy
the
statutory
requirements
for
reregistration.
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.

(
ii)
Respondent
Activities
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,
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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.
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
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
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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
the
registrant
(
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.

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
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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
the
registrant's
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
waiver
request.

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.

A
registrant
responding
to
a
DCI
issued
by
EPA
once
it
determines
that
the
available
information
is
not
sufficient
to
satisfy
the
statutory
requirements
for
reregistration
should
first
search
its
internal
records
to
identify
any
data
or
information
that
they
may
have
which
will
satisfy
the
DCI.
Although
the
Agency
searches
for
publicly
available
data
and
information,
the
registrant
may
have
unpublished
data
or
information
that
might
satisfy
the
identified
data
need,
and
may
not
need
to
generate
additional
data.
If
the
registrant
does
not
have
any
data
or
information
available,
they
should
then
proceed
planning
the
research
and/
or
studies
necessary
to
generate
the
data
required
to
satisfy
the
identified
data
need.

In
general,
the
burden
and
cost
estimates
in
this
ICR
assume
that
a
registrant
must
engage
in
the
following
activities
in
order
to
comply
with
a
DCI:
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read
instructions
read
the
DCI
letter
to
understand
what
data
are
to
be
submitted;
or
read
PR
Notice
97­
1
to
learn
what
voluntary
data
would
be
useful
to
EPA;

plan
activities
plan
the
activities
necessary
to
comply
with
the
DCI,
or
develop
options
to
avoid
having
to
submit
data
(
includes
time
for
reviewing
internal
company
information
for
existing
data);

create
information
conduct
research,
administer
tests,
analyze
data
to
develop
studies,
perform
laboratory
analysis,
write
study
documents
(
only
if
no
data
is
available
within
registrant
control);

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
in
company
files.

Attachment
G
provides
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.

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

develop
DCI
correspondence
Prepare
the
DCI
letter
identifying
all
data
needed;

answer
registrant
questions
respond
to
any
questions
the
registrant
may
have
regarding
the
DCI;

record
DCI
submissions
record
submissions
in
tracking
system
for
internal
review;

analyze
data
conduct
scientific
reviews
of
the
data;

store
data
index
data
and
store
it
in
Agency
files.

5(
b).
Collection
Methodology
and
Management
OPP
has
completed
a
major
review
of
its
information
tracking
systems
to
improve
their
efficiency
and
accuracy.
This
review
resulted
in
the
development
of
a
new
integrated
information
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system,
which,
when
complete,
will
improve
the
quality
of
the
Agency's
databases
and
allows
the
EPA
to
respond
more
timely
and
accurately
to
queries
from
registrants
and
the
public,
including
requests
made
under
the
FOIA.

OPP
is
also
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
Agency­
wide
workgroup
to
develop
electronic
reporting
standards
intended
to
facilitate
collection
of
information
from
industry.

OPP
does
not
publish
the
studies
submitted.
However,
it
maintains
records
of
each
study
in
the
Pesticide
Document
Management
System
(
PDMS),
and
provides
public
access
to
the
PDMS
bibliography
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,
and
the
public
may
request
copies
of
studies
that
are
non­
confidential
by
submitting
a
FOIA
request.

5(
c).
Small
Entity
Flexibility
Registrants
who
purchase
registered
pesticide
products
for
reformulation
or
further
manufacture
obtain
federal
registration,
but
they
generally
do
not
have
responsibility
for
supplying
generic
data
(
unless
the
basic
registrant
does
not
fully
support
all
the
data
requirements
for
their
products).
Therefore,
they
normally
would
need
only
respond
to
a
DCI
for
generic
data
by
indicating
a
legitimate
claim
to
a
generic
data
exemption.
They
do
not
incur
any
other
information
burden
associated
with
a
generic
data
call­
in.
Such
registrants
however,
are
responsible
for
providing
the
data
and
information
required
by
a
Product­
Specific
DCI,
to
support
the
final
reregistration
of
their
end­
use
product(
s).

5(
d).
Collection
Schedule
There
is
no
periodic
schedule
for
the
collection.
The
data
call­
ins
are
issued
when
the
need
for
the
information
and/
or
data
is
identified,
and
require
a
one­
time
submission.

6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
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
burden
and
costs
for
the
paperwork
related
activities,
and
therefore
includes
the
paperwork
burden
and
costs
related
to
the
creation
and
gathering
of
the
data.
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6(
a).
Estimating
Respondent
Burden
The
total
burden
hours
for
respondents
to
comply
with
this
information
collection
activity
over
the
next
three
years
is
estimated
to
be
1,566,744
hours.
A
three
year
duration
of
equal
effort
is
assumed
for
this
information
collection
request,
so
the
total
annual
respondent
burden
is
estimated
to
be
522,248
hours
(
1,566,744
÷
3).

The
DCI
burden
estimate
is
dependent
upon
the
type
or
class
of
chemical
under
review
and
whether
there
is
a
high,
or
low
level
(
in
terms
of
complexity)
of
studies
required
for
a
particular
chemical.
This
information
collection
request
projects
that
decision
documents
for
approximately
142
pesticide
ingredients
will
be
completed
during
FYs
2004­
2006
and
will
be
associated
with
DCIs
to
be
issued
over
the
next
three
years.
As
a
result
of
the
PRIA
of
2003,
a
handful
of
REDs
previously
scheduled
for
FYs2007
and
2008
are
being
scheduled
for
FYs
2005
and
2006,
and
are
included
among
the
142
ingredients
for
which
DCIs
are
expected
to
be
issued
under
this
ICR
renewal.
Of
those
142
pesticide
ingredients,
reregistration
will
account
for
91
through
Reregistration
Eligibility
Decisions
(
REDs)
and
Interim
Reregistration
Eligibility
Decisions
(
IREDs)
that
will
become
full
REDs
within
the
renewal
period,
and
tolerance
reassessment
will
account
for
48
through
Tolerance
Reassessment
Decisions
(
TREDs)
and
3
through
other
documentation
for
ingredients
with
no
U.
S.
registrations
but
with
import
tolerances.
With
most
REDs,
the
Agency
will
probably
issue
data
call­
ins
(
DCIs)
for
product
reregistration.
Calculations
for
the
burden
estimates
of
this
ICR
are
based
only
on
Phase
5
activities
and
for
reassessing
existing
tolerances.
The
type
of
information
that
the
Agency
may
require
respondents
to
submit
or
respondents
may
voluntarily
submit
to
the
Agency
can
generally
be
described
in
three
categories.
All
three
data
types
have
been
considered
in
estimating
the
respondent
burden.

°
Confirmatory
Data
­
studies
not
previously
required
that
EPA
needs
to
confirm
risk
findings
in
concluding
the
reregistration
process
and
issuing
REDs;
°
Product­
Specific
Data
­
acute
toxicity
and
product
chemistry
studies
required
for
pesticides
completing
product
reregistration;
and
°
Voluntary
Studies
­
studies
not
required
by
the
Agency,
but
submitted
voluntarily
by
registrants
to
supplement
studies
originally
submitted
to
show
that
the
pesticide
risks
are
lower
than
EPA
might
otherwise
conclude.

Confirmatory
data
and
product
specific
data
will
be
called
in
on
an
as­
needed
basis.
The
Agency
does
not
know
how
many
voluntary
studies
will
be
submitted
by
registrants
because
this
information
is
developed
and
submitted
at
the
registrants'
own
discretion.
However,
EPA
examined
the
confirmatory,
product
specific
and
voluntary
data
that
have
been
submitted
for
representative
pesticides
recently
or
currently
in
the
reregistration
and
tolerance
reassessment
process
and
has
used
this
information
to
project
the
estimates
in
this
ICR.

Confirmatory
data
are
required
of
registrants
to
fill
gaps
in
registrant
databases
and
to
assist
in
the
evaluation
of
risk
findings.
In
estimating
the
burden
related
to
confirmatory
data,
the
Agency
reviewed
thirty­
four
REDs
and
TREDs
(
from
FYs
2001
and
2002)
and
the
list
of
studies
requested
to
be
submitted.
An
average
number
of
confirmatory
studies
requested
was
9.8
studies,
most
of
which
were
new
study
requests.
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Voluntary
data
consist
of
studies
not
required
by
the
Agency
but
are
submitted
by
registrants
to
supplement
a
pesticide
database.
Based
on
a
sampling
of
the
REDs
affected
by
FQPA
tolerance
reassessment,
EPA
recognizes
that
some
registrants
will
submit
voluntary
data.
In
previous
years,
EPA
estimated
that
approximately
one­
half
of
the
REDs
will
have
voluntary
data
submittals.
To
account
for
the
burden
attributed
to
voluntarily
submitted
data,
the
Agency
inventoried
the
data
types
that
had
been
submitted
for
a
range
of
chemicals.
The
burden
was
divided
into
ranges
designated
as
low
burden
studies
(
one­
third
of
all
REDs)
or
high
burden
studies
(
one­
sixth
of
all
REDs).
Of
91
REDs/
IREDs
expected
to
be
completed
by
FY2006,
one
could
anticipate
as
many
as
30
"
low
burden"
and
15
"
high
burden"
responses.
However,
a
search
of
the
Agency's
OPPIN
database
shows
that
since
January
1,
1996
there
have
been
67
extraneous
data
submissions
received
over
a
period
of
8.25
years,
with
an
average
of
about
8
extraneous
data
submissions
per
year.
If
this
burden
is
attributed
to
24
such
submissions
over
the
next
three
years,
then
16
submissions
are
expected
to
be
"
low
burden"
and
8
submissions
may
be
considered
"
high
burden."
Many
of
these
studies
submitted
will
probably
be
existing
studies,
e.
g.,
studies
that
were
found
in
existing
literature,
or
studies
that
were
slightly
modified
and
resubmitted,
or
studies
of
lower
cost.
Some
may
be
special
studies
such
as
a
MONTE
CARLO,
or
limited
market
basket
survey,
or
other
studies
to
provide
the
Agency
with
actual
exposure
data.
The
Agency
averaged
the
burden
hours
related
to
voluntary
studies
as
if
they
represented
a
cross
section
of
typical
data
requirements.

Generally,
product
specific
data
is
comprised
of
toxicity
and
product
chemistry
data.
EPA
estimated
the
respondent
burden
for
product
specific
DCIs
by
developing
a
typical
reregistration
case
with
a
typical
number
of
batches
and
estimating
the
number
and
type
of
studies
required.
Calculations
estimate
the
average
burden
hour
and
dollar
costs
associated
with
preparing
and
submitting
those
studies.
The
number
of
responses
per
RED
varies
greatly
from
1
to
more
than
100,
but
due
to
the
efforts
to
pool
resources,
complete
industry
responses
should
average
3
responses
per
RED.
Due
to
the
citation
of
data
on
similar
products
and
the
citation
of
existing
data
previously
submitted
to
the
Agency,
the
number
of
studies
called
in
under
the
DCI
typically
differs
significantly
from
the
number
of
new
studies
actually
generated
in
response
to
the
DCI.
The
Agency
previously
determined
that
for
the
Acute
Toxicity,
a
sample
of
approximately
95
reviews
from
five
randomly
selected
chemicals
were
evaluated.
This
evaluation
was
performed
to
determine
the
number
of
new
studies
generated
in
response
to
the
DCI.
Based
on
this
evaluation,
it
was
determined
that
approximately
18%
of
the
Acute
Toxicity
data
requirements
are
newly
generated
in
response
to
the
DCI.
Among
the
six
Acute
Toxicity
requirements
(
acute
oral,
acute
dermal,
acute
inhalation,
acute
eye
irritation,
acute
dermal
irritation
and
dermal
sensitization),
the
Acute
eye
irritation
(
870.2400),
and
Acute
dermal
irritation
(
870.2500)
studies
may
account
for
as
much
as
50%
of
the
new
data
produced
(
in
equal
proportions).
The
other
50%
of
the
new
data
is
equally
distributed
between
the
remaining
four
study
requirements.

For
the
Product
Chemistry,
the
percent
of
new
data
produced
in
response
to
the
DCI
is
based
on
Product
Chemistry
reviewer
estimates
from
previous
reviews.
This
process
established
that
approximately
10%
of
the
Product
Chemistry
data
requirements
are
newly
generated
in
response
to
the
DCI.
Among
the
Product
Chemistry
Requirements,
typically
the
Storage
Stability
(
830.6317),
Corrosion
Characteristics
(
830.6320),
Viscosity
(
830.7100)
and
Analytical
Methods
(
830.1800)
guidelines
may
account
for
up
to
90%
of
the
new
data
produced
(
in
equal
proportions).
The
remaining
new
data
is
equally
distributed
between
the
Flammability
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(
830.6315),
pH
(
830.7000),
Density
(
830.7300),
and
various
requirements
for
technical/
pure
active
ingredients
including
Preliminary
analysis
(
830.1700),
Water
solubility
(
830.7840
or
830.7860),
and
Vapor
pressure
(
830.7950)
for
a
total
of
about
10
guidelines.
Ideally,
the
remaining
product
chemistry
requirements
have
already
been
generated
at
registration
since
the
information
is
inherent
to
the
production
process
[
e.
g.
Product
identity
and
composition
(
830.1550),
Description
of
formulation
process
(
830.1650)].

In
developing
these
estimates,
EPA
assumed
that:
studies
were
submitted
by
registrants
(
not
by
grower
groups,
other
agencies,
etc.);
studies
had
not
been
requested
under
a
previous
Data
Call­
In;
studies
were
not
a
request
to
resubmit
because
the
original
study
submitted
was
not
complete
or
did
not
meet
the
data
submission
requirements;
and
studies
submitted
that
are
based
on
preexisting
data
and
can
be
found
in
published,
peer
reviewed
literature
were
not
included.

The
following
tables
illustrate
the
respondent
paperwork
burden
hours
and
costs
for
voluntary,
confirmatory
and
product
specific
tests.
Followed
by
the
agency's
burden
hours
and
costs
associated
with
this
collection
activity,
a
presentation
of
the
total
burden
and
costs
for
this
ICR,
an
explanation
of
the
changes
in
the
burden
estimate
since
the
last
ICR
approval,
and
the
burden
statement
for
this
ICR.
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Table
1.
Respondent
Burden
for
DCIs
Involving
Confirmatory
Studies
a
Collection
Activities
Burden
Hours
Total
Mgmt.
$
130/
hr
Tech.
$
88/
hr
Cler.
$
40/
hr
Hours
Costs
1.
Read
and
discuss
test
requirements
12
0
0
12
$
1,560
2.
Discuss
test
and
protocol
with
Agency
6
6
0
12
$
1,308
3.
Plan
activities
24
6
0
30
$
3,648
4.
Create
information
18
299
36
353
$
30,092
5.
Gather
information
0
30
0
30
$
2,640
6.
Process,
compile,
review
information
for
accuracy
35
48
0
83
$
8,774
7.
Complete
written
forms
0
0
12
12
$
480
8.
Record,
disclose,
display
information
11
0
24
35
$
2,390
9.
Store,
file,
or
maintain
information
11
0
18
29
$
2,150
Total
Burden
117
389
90
596
$
53,042
No
change
in
burden
hour
distribution
since
the
last
ICR.
Update
in
the
cost
per
labor
hour.

Estimated
Total
Annual
Respondent
Burden
&
Costs
for
DCIs
Involving
Confirmatory
Studies:
Burden:
596
hours
per
response
x
approximately
446
responses
=
276,544
burden
hours.
Costs:
$
53,042
per
response
x
approximately
446
responses
=
$
24,611,488
It
is
assumed
that
for
142
RED/
IRED/
TRED/
etc.
pesticide
ingredients
there
will
be
an
average
of
9.8
confirmatory
studies,
which
will
result
in
a
maximum
annual
total
of
1,392
responses
(
142
x
9.8)
over
the
three­
year
period
of
the
ICR.
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Table
2.
A.
Respondent
Burden
for
Submissions
of
Voluntary
Low
Burden
Studies
Collection
Activities
Burden
Hours
Total
Mgmt.
$
130/
hr
Tech.
$
88/
hr
Cler.
$
40/
hr
Hours
Costs
1.
Read
and
discuss
test
requirements
12
0
0
12
$
1,560
2.
Discuss
test
and
protocol
with
Agency
6
6
0
12
$
1,308
3.
Plan
activities
24
6
0
30
$
3,648
4.
Create
information
18
299
36
353
$
30,092
5.
Gather
information
0
30
0
30
$
2,640
6.
Process,
compile,
review
information
for
accuracy
35
48
0
83
$
8,774
7.
Complete
written
forms
0
0
12
12
$
480
8.
Record,
disclose,
display
information
11
0
24
35
$
2,390
9.
Store,
file,
or
maintain
information
11
0
18
29
$
2,150
Total
per
Respondent
Burden
117
389
90
596
$
53,042
Estimated
Total
Annual
Respondent
Burden
&
Costs
for
DCIs
Involving
Voluntary
Low
Burden:
Burden:
596
hours
x
5.3
responses
=
3,179
hours
Costs:
$
53,042
x
5.3
responses
=
$
282,890
It
is
assumed
that
over
three
years
there
will
be
no
more
than
24
extraneous
data
submissions
of
which
sixteen
responses
(
0.67
x
24)
will
include
voluntary
low
burden
studies.
The
hourly
burden
is
assumed
to
be
10%
of
the
1996
ICR's
list
C&
D
chemicals
burden
hour
estimate
generated
for
the
1996
ICR
and
reviewed
in
2000,
and
updated
such
that
the
$/
per
hour
for
each
labor
category
is
based
upon
the
accepted
fully
loaded
labor
rate
for
each
of
the
three
labor
categories.

Table
2.
B.
Respondent
Burden
for
Submission
of
Voluntary
High
Burden
Studies
Collection
Activities
Burden
Hours
Total
Mgmt.
$
130/
hr
Tech.
$
88/
hr
Cler.
$
40/
hr
Hours
Costs
1.
Read
and
discuss
test
requirements
72
0
0
72
$
9,360
2.
Discuss
test
and
protocol
with
Agency
36
36
0
72
$
7,848
3.
Plan
activities
144
36
0
180
$
21,888
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4.
Create
information
108
1,791
215
2,114
$
180,248
5.
Gather
information
0
179
0
179
$
15,752
6.
Process,
compile,
review
information
for
accuracy
215
287
0
502
$
53,206
7.
Complete
written
forms
0
0
72
72
$
2,880
8.
Record,
disclose,
display
information
72
0
144
216
$
15,120
9.
Store,
file,
or
maintain
information
72
0
108
180
$
13,680
Total
Burden
719
2,329
539
3,587
$
319,982
Estimated
Total
Annual
Respondent
Burden
for
DCIs
Involving
Voluntary
High
Burden:
Burden:
3,587
hours
x
3
responses
=
9,565
hours
Costs:
$
319,982
x
3
responses
=
$
853,285
It
is
assumed
that
over
three
years
there
will
be
no
more
than
24
extraneous
data
submissions
of
which
eight
responses
(
0.33
x
24)
will
include
voluntary
high
burden
studies.
The
hourly
burden
is
assumed
to
be
10%
of
the
1996
ICR's
list
C&
D
chemicals
burden
hour
estimate
generated
for
the
1996
ICR
and
reviewed
in
2000,
and
updated
such
that
the
$/
per
hour
for
each
labor
category
is
based
upon
the
accepted
fully
loaded
labor
rate
for
each
of
the
three
labor
categories.
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Table
3.
Respondent
Burden
Estimates
for
Product
Specific
DCI
Activities
a
Collection
Activities
Burden
Hours
Total
Mgmt.
$
130/
hr
Tech.
$
88/
hr
Cler.
$
40/
hr
Hours
Costs
1.
Read
and
discuss
test
requirements
51
0
0
51
$
6,630
2.
Discuss
test
and
protocol
with
Agency
26
26
0
52
$
5,668
3.
Plan
activities
102
26
0
128
$
15,548
4.
Create
information
77
1,280
154
1,511
$
128,810
5.
Gather
information
0
128
0
128
$
11,264
6.
Process,
compile,
review
information
for
accuracy
154
204
0
358
$
37,972
7.
Complete
written
forms
0
0
51
51
$
2,040
8.
Record,
disclose,
display
information
51
0
102
153
$
10,710
9.
Store,
file,
or
maintain
information
51
0
77
128
$
9,710
Total
Burden
512
1,664
384
2,560
$
228,352
Estimated
Total
Annual
Respondent
Burden
for
Product
Specific
DCI
Activities:
Burden:
2,560
hours
x
91
responses
=
232,960
hours.
Costs:
$
228,352
x
91
responses
=
$
20,780,932
It
is
assumed
that
only
REDs
will
require
product
DCIs
and
that
for
91
RED/
IRED
pesticide
ingredients
there
will
be,
due
to
the
efforts
to
pool
resources,
an
average
of
3
responses
per
RED
(
the
same
as
expected
in
the
previous
ICR)
and
there
will
be
a
total
of
273
(
91
x
3)
responses.

6(
b).
Estimating
Respondent
Costs
The
total
annual
cost
to
all
respondents
to
comply
with
the
DCIs
potentially
issued
under
this
ICR
is
estimated
to
be
$
46,528,595,
with
the
total
respondent
costs
over
three
years
estimated
to
be
$
139,585,575.

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.
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These
estimates
are
representative
of
the
expected
costs
per
chemical
based
on
an
average
cost
using
sample
DCIs,
and
the
estimated
number
of
respondents
for
each
DCI
based
on
the
type
of
DCI
as
discussed
above.
Some
respondents
will
spend
less
effort
and
others
with
several
chemicals
or
products
will
have
more
complicated
requirements
and
spend
more
time
than
the
average
estimated.
Other
respondents
may
experience
much
less
burden,
e.
g.,
if
they
already
have
data
that
was
otherwise
unavailable
to
EPA,
or
if
they
request
and
receive
a
waiver.

6(
c).
Estimating
Agency
Burden
and
Cost
In
the
previous
ICR,
the
Agency
estimated
it
would
spend
99,135
hours
at
a
cost
of
$
6,003,810
per
year
to
perform
the
duties
and
activities
as
required
to
support
DCIs
issued
for
10
REDs
annually.
Of
that
total,
the
Agency
estimated
4,975
hours
or
$
300,184
would
be
spent
performing
paperwork
and
record
keeping
activities.
The
Agency's
labor
burden
included
developing
DCI
correspondence,
communication
with
registrants,
and
documenting
and
storing
the
evaluation
of
the
data
submissions.
However,
in
this
ICR,
the
Agency
is
increasing
its
annual
burden
estimate
to
reflect
an
increase
in
REDs/
IREDs/
TREDs/
etc.
by
4.73­
fold
(
from
10
to
47.3)
annually.

Agency
labor
rates
are
$
96,
$
70,
and
$
33
per
hour
for
management,
technical,
and
clerical
staff,
respectively.
These
rates
are
based
on
Office
of
Personnel
Management
salary
tables
for
federal
employees
for
the
years
1999
through
2001
and
include
benefits
and
overhead
costs,
as
well
as
locality
pay
for
the
Washington,
DC­
Baltimore
area.
The
details
of
the
calculations
are
given
below.

Table
4.
Annual
Agency
Burden
Estimates
a
Collection
Activities
Burden
Hours
Total
Mgmt.
$
96/
hr
Tech.
$
70/
hr
Cler.
$
33/
hr
Hours
Costs
a.
Develop
DCI
correspondence
2,838
28,380
2,838
34,056
$
2,352,702
b.
Answer
DCI
questions
from
registrants
355
14,190
0
14,545
$
1,027,356
c.
Review,
evaluate
data
submission
710
413,21
0
413,92
$
28,993,00
d.
Record
DCI
submissions
0
0
5,676
5,676
$
187,308
e.
Store
data
0
0
710
710
$
23,414
Total
Annual
Agency
Burden
3,902
455,78
3
9,224
468,90
9
$
32,583,78
8
a
No
change
in
hour
burden
distribution
among
labor
types
since
the
last
ICR.
Update
in
the
total
number
of
hours
(
4.73­
fold
increase)
and
cost
per
labor
hour.
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6(
d).
Bottom
Line
Hours
and
Cost
Tables
As
indicated
previously,
EPA
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.
In
addition
to
the
submissions
in
response
to
DCIs
issued
by
EPA,
this
ICR
includes
estimated
burden
and
costs
for
voluntary
submissions.
The
total
estimate
represents
the
activities
that
are
currently
estimated
to
occur
over
the
next
three
years.
Since
the
Agency
assumes
that
these
activities
involve
an
equal
level
of
effort
over
this
period,
the
estimated
annual
burden
and
costs
is
derived
from
a
simple
division
of
the
total
burden
and
costs
by
3.
The
following
table
provides
the
total
burden
and
costs
for
Respondents,
the
annual
burden
and
costs
for
Respondents,
and
the
total
burden
and
costs
for
the
Agency:

Table
5.
Bottom
Line
Hours
And
Costs
/
Master
Table
Collection
Activity
Burden
Hours
Costs
DCI
Involving
Confirmatory
Studies
276,544
$
24,611,488
Voluntary
Low
Burden
Studies
3,179
$
282,890
Voluntary
High
Burden
Studies
9,565
$
853,285
Product
Specific
DCIs
232,960
$
20,780,932
Total
Annual
Respondent
Burden
and
Costs
522,248
$
46,528,595
Total
Annual
Agency
Burden
468,909
$
32,583,788
The
terms
of
clearance
outlined
by
OMB
when
this
ICR
was
approved
in
2001
required
that
EPA
not
issue
any
DCI
unless
it
had
first
been
approved
by
relevant
high­
level
management
in
the
Office
of
Pesticide
Programs
and
approved
by
OMB.
In
the
approval
request,
EPA
was
to
estimate
the
respondent
burden
and
costs
related
to
specific
DCIs
before
they
were
issued,
including
the
total
cost
for
performing
the
required
study(
s),
and
the
associated
paperwork
related
burden
and
costs.
OMB
would
then
review
the
information
collection
activities
associated
with
each
individual
DCI
to
ensure
that
the
collection
of
information
was
the
least
burdensome
necessary
for
the
proper
performance
of
the
agency's
functions
and
that
the
collection
of
information
was
not
duplicative
of
information
otherwise
accessible
to
the
agency.
If
OMB
raised
no
questions
during
the
review
period,
EPA
could
issue
the
DCIs.

EPA
has
complied
with
these
terms
of
clearance
by
submitting
requests
to
OMB
for
approval
of
DCIs
for
a
total
of
35
chemicals.
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6(
e).
Reasons
for
Change
In
Burden
The
following
program
changes
have
affected
the
calculations
in
this
ICR:

1)
The
number
of
REDs/
TREDs
to
be
completed
over
the
next
three
years
will
increase
dramatically
as
less
complex
and
less
controversial
chemicals
are
reviewed
and
therefore
the
number
of
DCIs
will
increase
proportionally.
2)
Calculating
the
number
of
responses
to
confirmatory
studies
will
increase
not
only
to
reflect
the
increase
in
REDs/
TREDs
expected
to
be
completed,
but
also
to
correct
a
calculation
error
in
the
previous
ICR.
While
in
the
previous
ICR,
30
food­
use
REDs
with
an
average
of
9.35
confirmatory
studies
would
result
in
281
(
30
x
9.35)
responses,
only
30
responses
were
estimated.
The
previous
ICR
was
associated
mainly
with
controversial
pesticide
active
ingredients,
such
as
organophosphates.
For
controversial
pesticide
active
ingredients,
a
number
of
registrants
may
choose
not
to
support
the
active
ingredient's
reregistration
and
not
respond
to
the
generic
DCI
for
economic
reasons,
resulting
in
the
need
to
issue
fewer
DCIs.
Nevertheless,
the
previous
ICR
appears
to
have
greatly
underestimated
the
number
of
responses
expected
for
confirmatory
studies,
possibly
by
failing
to
multiply
the
number
of
REDs
by
the
number
of
studies
per
RED.
In
this
ICR,
EPA
has
calculated
that
the
number
of
responses
will
be
greater
for
DCIs
involving
confirmatory
studies
because
of
the
increased
number
of
non­
controversial
REDs/
TREDs
that
are
to
be
completed
over
a
three
year
period
(
from
30
to
142).
Also,
the
Agency
is
adjusting
a
slight
increase
in
the
average
of
such
studies
per
RED
(
from
9.35
to
9.8)
based
on
more
recent
REDs
(
from
2001
and
2002)
and
applying
that
full
number
per
RED/
TRED.
Therefore,
in
this
ICR
the
Agency
estimates
there
will
be
1,392
(
142
x
9.8)
responses
involving
confirmatory
studies.
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.

3)
EPA
has
continued
to
include
the
burden
and
costs
related
to
the
voluntary
submission
of
data
for
food
use
RED/
TRED
active
ingredients.
However,
the
number
of
responses
is
expected
to
be
fewer
than
anticipated
in
the
previous
ICR
(
which
used
one­
half
the
RED
number)
because
the
91
REDs/
IREDs
to
be
completed
in
FYs2004­
2006
and
associated
with
this
ICR
are
mostly
less
controversial
chemicals
than
those,
such
as
organophosphate
chemicals,
that
were
associated
with
the
previous
ICR.
In
fact,
a
recent
search
in
OPP's
OPPIN
database
for
extraneous
data
submissions
received
by
the
Agency
since
January
1,
1996
showed
an
average
of
only
8
submissions
per
year.
Over
a
three
year
period,
twenty­
four
such
data
submissions
are
expected.
DRAFT
FOR
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COMMENT
April
13,
2004
Page
24
of
65
The
following
adjustment
related
changes
have
affected
the
calculations
in
this
ICR:

1)
Given
that
the
reregistration
program
is
in
phase
5,
and
considering
that
the
Agency
expects
to
complete
all
remaining
food
use
REDs
by
the
end
of
FY2006,
EPA
has
adjusted
the
number
of
(
RED/
IRED/
TRED
plus
AIs
with
import
tolerance)
responses
expected
for
the
next
three
years
to
142.
In
the
previous
ICR,
the
Agency
had
expected
that
for
30
food­
use
REDs
there
would
be
an
average
of
9.35
studies
per
RED,
but
only
a
total
of
30
responses
for
DCIs
involving
confirmatory
studies
over
three
years.
In
this
ICR,
the
Agency
expects
to
adjust
the
number
of
REDs,
IREDs,
TREDs,
etc.
to
142
completions
through
the
end
of
FY2006.
Also,
the
Agency
recently
reviewed
REDs
and
TREDs
(
from
2001
and
2002)
and
determined
an
average
of
9.8
confirmatory
studies.
Therefore,
a
maximum
of
1,392
responses
(
142
x
9.8)
is
expected
for
confirmatory
studies.

2)
The
Agency
is
adjusting
PDCI
responses
based
on
the
number
of
REDs
expected
to
be
completed
for
FYs
2004­
2006,
and
for
which
the
Agency
expects
to
issue
PDCIs
over
the
next
three
years.
EPA
has
reviewed
thirty
four
REDs/
TREDs
(
from
2001
and
2002).
TREDs
are
issued
regarding
FQPA
tolerance
reassessment,
not
reregistration
of
an
active
ingredient
and
its
products.
TREDs
are
completed
to
reassess
tolerances
in
cases
where
either
a
RED
was
completed
prior
to
FQPA,
registration
was
completed
post­
1984
and
no
RED
is
required,
or
for
import
tolerances
concerning
ingredients
without
active
U.
S.
registrations.
Generally,
TREDs
do
not
require
a
product
DCI.
Therefore,
the
Agency
adjusted
the
number
of
expected
responses
to
PDCIs.
It
is
assumed
that
for
91
RED
chemicals
there
will
be,
due
to
the
efforts
to
pool
resources,
an
average
of
3
responses
per
RED
(
the
same
as
was
estimated
in
the
previous
ICR).
For
91
REDs
with
3
responses
per
RED,
there
will
be
a
total
of
273
(
91
x
3)
responses
to
PDCIs.

3)
EPA
has
updated
the
hourly
rates
used
to
calculate
costs.

4)
In
comparing
the
estimated
total
burden
between
these
ICRs,
an
increase
in
the
burden
is
evident.
In
the
previous
ICR,
the
total
burden
came
to
272,175
hours,
or
90,725
hours
annually,
compared
to
the
total
burden
for
this
ICR
of
1,566,744
hours,
or
522,248
hours
annually.
This
increase
of
about
5.76­
fold
in
burden
hours
includes
an
overall
increase
of
4.73­
fold
in
the
number
of
REDs,
IREDs,
and
TREDs,
etc.
which
the
Agency
expects
to
complete
during
FYs
2004­
2006
and
for
which
the
Agency
expects
to
generate
DCIs
over
the
next
three
years.
The
discrepancy
in
increases
likely
reflects
two
factors:
(
a)
the
underestimation
in
the
previous
ICR
regarding
the
number
of
responses
(
281
likely
vs
30
estimated)
for
DCIs
involving
confirmatory
studies
and
therefore
the
total
number
of
hours
involving
confirmatory
studies
(
167,476
vs
17,880
estimated),
which
would
have
increased
the
annual
burden
hours
to
about
140,590,
and
(
b)
the
fact
that
the
DRAFT
FOR
PUBLIC
COMMENT
April
13,
2004
Page
25
of
65
previous
ICR
was
associated
only
with
RED
chemicals
and
this
ICR
is
associated
with
a
mix
of
chemicals
of
which
about
two­
thirds
concern
REDs
and
one­
third
concern
TREDs,
and
TREDs
generally
do
not
need
PDCIs
and
their
associated
paperwork
burden
costs.

The
program
changes
and
adjustments
related
to
the
phase
5
reregistration
activities
and
tolerance
reassessment
activities
have
offset
the
anticipated
pre­
FQPA
respondent
burden
reductions,
resulting
in
the
net
increase.
It
is
also
important
to
point
out
that
the
burden
and
cost
estimates
in
this
ICR
are
intended
to
represent
potential
burden
and
costs.
As
such,
some
respondents
that
receive
DCIs
may
have
paperwork
burden
hours
and
costs
greater
than
the
average
estimates,
while
the
costs
for
others
may
be
lower
than
the
average
estimates.

6(
f).
Burden
Statement
The
total
burden
hours
for
respondents
to
comply
with
this
information
collection
activity
over
the
next
three
years
is
estimated
to
be
1,566,744
hours.
A
three
year
duration
of
equal
effort
is
assumed
for
this
information
collection
request,
so
the
total
annual
respondent
burden
is
estimated
to
be
522,248
hours.

According
to
the
Paperwork
Reduction
Act,
"
burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection,
it
is
the
time
reading
the
regulations,
planning
the
necessary
data
collection
activities,
conducting
tests,
analyzing
data,
generating
reports
and
completing
other
required
paperwork,
and
storing,
filing,
and
maintaining
the
data.
The
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
this
information
collection
appear
at
the
beginning
and
the
end
of
this
document.
In
addition
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPP­
2004­
0110,
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
DRAFT
FOR
PUBLIC
COMMENT
April
13,
2004
Page
26
of
65
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPP­
2004­
0110
and
OMB
Control
No.
2070­
0107
in
any
correspondence.
DRAFT
FOR
PUBLIC
COMMENT
April
13,
2004
Page
27
of
65
ATTACHMENTS
TO
THE
SUPPORTING
STATEMENT
ATTACHMENT
A:
FIFRA
section
4
­
also
available
electronically
at
http://
www.
epa.
gov/
oppfead1/
fqpa/

ATTACHMENT
B:
FIFRA
section
3(
c)(
2)(
B)­
also
available
electronically
at
http://
www.
epa.
gov/
oppfead1/
fqpa/
and
click
on
"
LAWS,"
then
click
on
the
available
PDF
file
for
FIFRA.

ATTACHMENT
C:
Data
Call­
In
Response
Form
ATTACHMENT
D:
Requirements
Status
and
Registrant's
Response
Form
ATTACHMENT
E:
Certification
of
Attempt
to
Enter
into
an
Agreement
with
Registrants
for
Development
of
Data
(
EPA
Form
8570­
32)
­
also
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/

ATTACHMENT
F:
Certification
with
Respect
to
Citation
of
Data
(
EPA
Form
8570­
34)
­
also
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/

ATTACHMENT
G:
Estimating
the
Potential
Paperwork
Burden
and
Cost
for
DCIs.

ATTACHMENT
H:
ICR
for
Reregistration
Program:
List
of
RED/
IRED,
TRED,
and
Import
Tolerance
Pesticide
Candidates
Estimated
To
Have
DCI
Needs
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
28
of
65
Sec.
4.
[
136a­
1]
Reregistration
of
Registered
Pesticides.

(
a)
General
Rule.­­
The
Administrator
shall
reregister,
in
accordance
with
this
section,
each
registered
pesticide
containing
any
active
ingredient
contained
in
any
pesticide
first
registered
before
November
1,
1984,
except
for
any
pesticide
as
to
which
the
Administrator
has
determined,
after
November
1,
1984,
and
before
the
effective
date
of
this
section,
that
 
(
1)
there
are
no
outstanding
data
requirements;
and
(
2)
the
requirements
of
section
3(
c)(
5)
of
this
title
have
been
satisfied.

(
b)
Reregistration
Phases.­­
Reregistrations
of
pesticides
under
this
section
shall
be
carried
out
in
the
following
phases:

(
1)
The
first
phase
shall
include
the
listing
under
subsection
(
c)
of
the
active
ingredients
of
the
pesticides
that
will
be
reregistered.

(
2)
The
second
phase
shall
include
the
submission
to
the
Administrator
under
subsection
(
d)
of
notices
by
registrants
respecting
their
intention
to
seek
reregistration,
identification
by
registrants
of
missing
and
inadequate
data
for
such
pesticides,
and
commitments
by
registrants
to
replace
such
missing
or
inadequate
data
within
the
applicable
time
period.

(
3)
The
third
phase
shall
include
submission
to
the
Administrator
by
registrants
of
the
information
required
under
subsection
(
e).

(
4)
The
fourth
phase
shall
include
an
independent,
initial
review
by
the
Administrator
under
subsection
(
f)
of
submissions
under
phases
two
and
three,
identification
of
outstanding
data
requirements,
and
the
issuance,
as
necessary,
of
requests
for
additional
data.

(
5)
The
fifth
phase
shall
include
the
review
by
the
Administrator
under
subsection
(
g)
of
data
submitted
for
reregistration
and
appropriate
regulatory
action
by
the
Administrator.

(
c)
Phase
One.­­

(
1)
Priority
for
Reregistration.­­
For
purposes
of
the
reregistration
of
the
pesticides
described
in
subsection
(
a),
the
Administrator
shall
list
the
active
ingredients
of
pesticides
and
shall
give
priority
to,
among
others,
active
ingredients
(
other
than
active
ingredients
for
which
registration
standards
have
been
issued
before
the
effective
date
of
this
section)
that
 
(
A)
are
in
use
on
or
in
food
or
feed
and
may
result
in
postharvest
residues;

(
B)
may
result
in
residues
of
potential
toxicological
concern
in
potable
ground
water,
edible
fish,
or
shellfish;
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
29
of
65
(
C)
have
been
determined
by
the
Administrator
before
the
effective
date
of
this
section
to
have
significant
outstanding
data
requirements;
or
(
D)
are
used
on
crops,
including
in
greenhouses
and
nurseries,
where
worker
exposure
is
most
likely
to
occur.

(
2)
Reregistration
Lists.­­
For
purposes
of
reregistration
under
this
section,
the
Administrator
shall
by
order
 
(
A)
not
later
than
70
days
after
the
effective
date
of
this
section,
list
pesticide
active
ingredients
for
which
registration
standards
have
been
issued
before
such
effective
date;

(
B)
not
later
than
four
months
after
such
effective
date,
list
the
first
150
pesticide
active
ingredients,
as
determined
under
paragraph
(
1);

(
C)
not
later
than
seven
months
after
such
effective
date,
list
the
second
150
pesticide
active
ingredients,
as
determined
under
paragraph
(
1);
and
(
D)
not
later
than
ten
months
after
such
effective
date,
list
the
remainder
of
the
pesticide
active
ingredients,
as
determined
under
paragraph
(
1).

Each
list
shall
be
published
in
the
Federal
Register.

(
3)
Judicial
Review.­­
The
content
of
a
list
issued
by
the
Administrator
under
paragraph
(
2)
shall
not
be
subject
to
judicial
review.

(
4)
Notice
to
Registrants.­­
On
the
publication
of
a
list
of
pesticide
active
ingredients
under
paragraph
(
2),
the
Administrator
shall
send
by
certified
mail
to
the
registrants
of
the
pesticides
containing
such
active
ingredients
a
notice
of
the
time
by
which
the
registrants
are
to
notify
the
Administrator
under
subsection
(
d)
whether
the
registrants
intend
to
seek
or
not
to
seek
reregistration
of
such
pesticides.

(
d)
Phase
Two.­­

(
1)
In
General.­­
The
registrant
of
a
pesticide
that
contains
an
active
ingredient
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
shall
submit
to
the
Administrator,
within
the
time
period
prescribed
by
paragraph
(
4),
the
notice
described
in
paragraph
(
2)
and
any
information,
commitment,
or
offer
described
in
paragraph
(
3).

(
2)
Notice
of
Intent
to
Seek
or
Not
to
Seek
Reregistration.­­

(
A)
The
registrant
of
a
pesticide
containing
an
active
ingredient
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
shall
notify
the
Administrator
by
certified
mail
whether
the
registrant
intends
to
seek
or
does
not
intend
to
seek
reregistration
of
the
pesticide.
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
30
of
65
(
B)
If
a
registrant
submits
a
notice
under
subparagraph
(
A)
of
an
intention
not
to
seek
reregistration
of
a
pesticide,
the
Administrator
shall
publish
a
notice
in
the
Federal
Register
stating
that
such
a
notice
has
been
submitted.

(
3)
Missing
or
Inadequate
Data.­­
Each
registrant
of
a
pesticide
that
contains
an
active
ingredient
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
and
for
which
the
registrant
submitted
a
notice
under
paragraph
(
2)
of
an
intention
to
seek
reregistration
of
such
pesticide
shall
submit
to
the
Administrator
 
(
A)
in
accordance
with
regulations
issued
by
the
Administrator
under
section
3,
an
identification
of
 
(
i)
all
data
that
are
required
by
regulation
to
support
the
registration
of
the
pesticide
with
respect
to
such
active
ingredient;

(
ii)
data
that
were
submitted
by
the
registrant
previously
in
support
of
the
registration
of
the
pesticide
that
are
inadequate
to
meet
such
regulations;
and
(
iii)
data
identified
under
clause
(
i)
that
have
not
been
submitted
to
the
Administrator;
and
(
B)
either­­

(
i)
a
commitment
to
replace
the
data
identified
under
subparagraph
(
A)(
ii)
and
submit
the
data
identified
under
subparagraph
(
A)(
iii)
within
the
applicable
time
period
prescribed
by
paragraph
(
4)(
B);
or
(
ii)
an
offer
to
share
in
the
cost
to
be
incurred
by
a
person
who
has
made
a
commitment
under
clause
(
i)
to
replace
or
submit
the
data
and
an
offer
to
submit
to
arbitration
as
described
by
section
3(
c)(
2)(
B)
with
regard
to
such
cost
sharing.

For
purposes
of
a
submission
by
a
registrant
under
subparagraph
(
A)(
ii),
data
are
inadequate
if
the
data
are
derived
from
a
study
with
respect
to
which
the
registrant
is
unable
to
make
the
certification
prescribed
by
subsection
(
e)(
1)(
G)
that
the
registrant
possesses
or
has
access
to
the
raw
data
used
in
or
generated
by
such
study.
For
purposes
of
a
submission
by
a
registrant
under
such
subparagraph,
data
shall
be
considered
to
be
inadequate
if
the
data
are
derived
from
a
study
submitted
before
January
1,
1970,
unless
it
is
demonstrated
to
the
satisfaction
of
the
Administrator
that
such
data
should
be
considered
to
support
the
registration
of
the
pesticide
that
is
to
be
reregistered.

(
4)
Time
Periods.
 
(
A)
A
submission
under
paragraph
(
2)
or
(
3)
shall
be
made
 
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
31
of
65
(
i)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
B),
not
later
than
three
months
after
the
date
of
publication
of
the
listing
of
such
active
ingredient;

(
ii)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
C),
not
later
than
3
three
months
after
the
date
of
publication
of
the
listing
of
such
active
ingredient;
and
(
iii)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
D),
not
later
than
three
months
after
the
date
of
publication
of
the
listing
of
such
active
ingredient.

On
application,
the
Administrator
may
extend
a
time
period
prescribed
by
this
subparagraph
if
the
Administrator
determines
that
factors
beyond
the
control
of
the
registrant
prevent
the
registrant
from
complying
with
such
period.

(
B)
A
registrant
shall
submit
data
in
accordance
with
a
commitment
entered
into
under
paragraph
(
3)(
B)
within
a
reasonable
period
of
time,
as
determined
by
the
Administrator,
but
not
more
than
48
months
after
the
date
the
registrant
submitted
the
commitment.
The
Administrator,
on
application
of
a
registrant,
may
extend
the
period
prescribed
by
the
preceding
sentence
by
no
more
than
two
years
if
extraordinary
circumstances
beyond
the
control
of
the
registrant
prevent
the
registrant
from
submitting
data
within
such
prescribed
period.
Upon
application
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
this
section
for
the
other
uses
of
the
pesticide
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996
if
 
(
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
this
section;
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
subparagraph,
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)
of
section
3(
c)(
2)(
B)
or
other
provisions
of
this
section,
as
appropriate,
regarding
the
continued
registration
of
the
affected
products
with
the
minor
use
and
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
32
of
65
shall
inform
the
public
of
such
action.
Notwithstanding
the
provisions
of
this
subparagraph,
the
Administrator
may
take
action
to
modify
or
revoke
the
extension
under
this
subparagraph
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
written
notice
to
the
registrant
revoking
the
extension
of
time
for
submission
of
data.
Such
data
shall
instead
be
due
in
accordance
with
the
date
then
established
by
the
Administrator
for
submission
of
the
data.

(
5)
Cancellation
and
Removal.­­

(
A)
If
the
registrant
of
a
pesticide
does
not
submit
a
notice
under
paragraph
(
2)
or
(
3)
within
the
time
prescribed
by
paragraph
(
4)(
A),
the
Administrator
shall
issue
a
notice
of
intent
to
cancel
the
registration
of
such
registrant
for
such
pesticide
and
shall
publish
the
notice
in
the
Federal
Register
and
allow
60
days
for
the
submission
of
comments
on
the
notice.
On
expiration
of
such
60
days,
the
Administrator,
by
order
and
without
a
hearing,
may
cancel
the
registration
or
take
such
other
action,
including
extension
of
applicable
time
periods,
as
may
be
necessary
to
enable
reregistration
of
such
pesticide
by
another
person.

(
B)(
i)
If­­

(
I)
no
registrant
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)
notifies
the
Administrator
under
paragraph
(
2)
that
the
registrant
intends
to
seek
reregistration
of
any
pesticide
containing
that
active
ingredient;

(
II)
no
such
registrant
complies
with
paragraph
(
3)(
A);
or
(
III)
no
such
registrant
makes
a
commitment
under
paragraph
(
3)(
B)
to
replace
or
submit
all
data
described
in
clauses
(
ii)
and
(
iii)
of
paragraph
(
3)(
A);

the
Administrator
shall
publish
in
the
Federal
Register
a
notice
of
intent
to
remove
the
active
ingredient
from
the
list
established
under
subsection
(
c)(
2)
and
a
notice
of
intent
to
cancel
the
registrations
of
all
pesticides
containing
such
active
ingredient
and
shall
provide
60
days
for
comment
on
such
notice.

(
ii)
After
the
60­
day
period
has
expired,
the
Administrator,
by
order,
may
cancel
any
such
registration
without
hearing,
except
that
the
Administrator
shall
not
cancel
a
registration
under
this
subparagraph
if­­

(
I)
during
the
comment
period
a
person
acquires
the
rights
of
the
registrant
in
that
registration;

(
II)
during
the
comment
period
that
person
furnishes
a
notice
of
intent
to
reregister
the
pesticide
in
accordance
with
paragraph
(
2);
and
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
33
of
65
(
III)
not
later
than
120
days
after
the
publication
of
the
notice
under
this
subparagraph,
that
person
has
complied
with
paragraph
(
3)
and
the
fee
prescribed
by
subsection
(
i)(
1)
of
this
section
has
been
paid.

(
6)
Suspensions
and
Penalties.­­
The
Administrator
shall
issue
a
notice
of
intent
to
suspend
the
registration
of
a
pesticide
in
accordance
with
the
procedures
prescribed
by
section
3(
c)(
2)(
B)(
iv)
if
the
Administrator
determines
that
(
A)
progress
is
insufficient
to
ensure
the
submission
of
the
data
required
for
such
pesticide
under
a
commitment
made
under
paragraph
(
3)(
B)
within
the
time
period
prescribed
by
paragraph
(
4)(
B)
or
(
B)
the
registrant
has
not
submitted
such
data
to
the
Administrator
within
such
time
period.
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
nonfood
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
nonfood
uses
of
the
pesticide,
the
Administrator,
at
the
written
request
of
the
registrant,
shall
not
take
any
action
pursuant
to
this
paragraph
in
regard
to
such
unsupported
minor
use
until
the
final
deadline
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996,
for
the
submission
of
data
under
this
section
for
the
supported
uses
identified
pursuant
to
this
paragraph
unless
the
Administrator
determines
that
the
absence
of
the
data
is
significant
enough
to
cause
human
health
or
environmental
concerns.
On
such
a
determination
the
Administrator
may
refuse
the
request
for
extension
by
the
registrant.
Upon
receipt
of
the
request
from
the
registrant,
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
paragraph,
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
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
section
3(
c)(
2)(
B)(
iv)
of
this
title
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)
of
this
title.
Notwithstanding
this
subparagraph,
the
Administrator
may
deny,
modify,
or
revoke
the
temporary
extension
under
this
paragraph
if
the
Administrator
determines
that
the
continuation
of
the
minor
use
may
cause
an
unreasonable
adverse
effect
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.

(
e)
Phase
Three.­­

(
1)
Information
about
Studies.­­
Each
registrant
of
a
pesticide
that
contains
an
active
ingredient
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
who
has
submitted
a
notice
under
subsection
(
d)(
2)
of
an
intent
to
seek
the
reregistration
of
such
pesticide
shall
submit,
in
accordance
with
the
guidelines
issued
under
paragraph
(
4),
to
the
Administrator
 
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
34
of
65
(
A)
a
summary
of
each
study
concerning
the
active
ingredient
previously
submitted
by
the
registrant
in
support
of
the
registration
of
a
pesticide
containing
such
active
ingredient
and
considered
by
the
registrant
to
be
adequate
to
meet
the
requirements
of
section
3
and
the
regulations
issued
under
such
section;

(
B)
a
summary
of
each
study
concerning
the
active
ingredient
previously
submitted
by
the
registrant
in
support
of
the
registration
of
a
pesticide
containing
such
active
ingredient
that
may
not
comply
with
the
requirements
of
section
3
and
the
regulations
issued
under
such
section
but
which
the
registrant
asserts
should
be
deemed
to
comply
with
such
requirements
and
regulations;

(
C)
a
reformat
of
the
data
from
each
study
summarized
under
subparagraph
(
A)
or
(
B)
by
the
registrant
concerning
chronic
dosing,
oncogenicity,
reproductive
effects,
mutagenicity,
neurotoxicity,
teratogenicity,
or
residue
chemistry
of
the
active
ingredient
that
were
submitted
to
the
Administrator
before
January
1,
1982;

(
D)
where
data
described
in
subparagraph
(
C)
are
not
required
for
the
active
ingredient
by
regulations
issued
under
section
3,
a
reformat
of
acute
and
subchronic
dosing
data
submitted
by
the
registrant
to
the
Administrator
before
January
1,
1982,
that
the
registrant
considers
to
be
adequate
to
meet
the
requirements
of
section
3
and
the
regulations
issued
under
such
section;

(
E)
an
identification
of
data
that
are
required
to
be
submitted
to
the
Administrator
under
section
6(
a)(
2),
indicating
an
adverse
effect
of
the
pesticide;

(
F)
an
identification
of
any
other
information
available
that
in
the
view
of
the
registrant
supports
the
registration;

(
G)
a
certification
that
the
registrant
or
the
Administrator
possesses
or
has
access
to
the
raw
data
used
in
or
generated
by
the
studies
that
the
registrant
summarized
under
subparagraph
(
A)
or
(
B);

(
H)
either­­

(
i)
a
commitment
to
submit
data
to
fill
each
outstanding
data
requirement
identified
by
the
registrant;
or
(
ii)
an
offer
to
share
in
the
cost
of
developing
such
data
to
be
incurred
by
a
person
who
has
made
a
commitment
under
clause
(
i)
to
submit
such
data,
and
an
offer
to
submit
to
arbitration
as
described
by
section
3(
c)(
2)(
B)
and
(
I)
evidence
of
compliance
with
section
3(
c)(
1)(
D)(
ii)
and
regulations
issued
thereunder
with
regard
to
previously
submitted
data
as
if
the
registrant
were
now
seeking
the
original
registration
of
the
pesticide.

A
registrant
who
submits
a
certification
under
subparagraph
(
G)
that
is
false
shall
be
considered
to
have
violated
this
Act
and
shall
be
subject
to
the
penalties
prescribed
by
section
14.
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
1Indentation
of
the
following
sentences
of
this
subparagraph
is
so
in
original
(
as
added
by
sec.
201(
c)(
2)
of
P.
L.
104­
170).
Probably
should
be
indented
the
same
as
flush
matter
of
this
subparagraph.

Page
35
of
65
(
2)
Time
Periods.­­

(
A)
The
information
required
by
paragraph
(
1)
shall
be
submitted
to
the
Administrator
 
(
i)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
B),
not
later
than
12
months
after
the
date
of
publication
of
the
listing
of
such
active
ingredient;

(
ii)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
C),
not
later
than
12
months
after
the
date
of
publication
of
the
listing
of
such
active
ingredient;
and
(
iii)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
D),
not
later
than
12
months
after
the
date
of
publication
of
the
listing
of
such
active
ingredient.

(
B)
A
registrant
shall
submit
data
in
accordance
with
a
commitment
entered
into
under
paragraph
(
1)(
H)
within
a
reasonable
period
of
time,
as
determined
by
the
Administrator,
but
not
more
than
48
months
after
the
date
the
registrant
submitted
the
commitment
under
such
paragraph.
The
Administrator,
on
application
of
a
registrant,
may
extend
the
period
prescribed
by
the
preceding
sentence
by
no
more
than
two
years
if
extraordinary
circumstances
beyond
the
control
of
the
registrant
prevent
the
registrant
from
submitting
data
within
such
prescribed
period.
Upon
application
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
this
section
for
the
other
uses
of
the
pesticide
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996
if
 
(
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
this
section;
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
environment1.
If
the
Administrator
grants
an
extension
under
this
subparagraph,
the
Administrator
shall
monitor
the
development
of
the
data
and
shall
ensure
that
the
registrant
is
meeting
the
schedule
for
the
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
36
of
65
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)
of
section
3(
c)(
2)(
B)
or
other
provisions
of
this
section,
as
appropriate,
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
subparagraph,
the
Administrator
may
take
action
to
modify
or
revoke
the
extension
under
this
subparagraph
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
written
notice
to
the
registrant
revoking
the
extension
of
time
for
submission
of
data.
Such
data
shall
instead
be
due
in
accordance
with
the
date
then
established
by
the
Administrator
for
submission
of
the
data.

(
3)
Cancellation.­­

(
A)
If
the
registrant
of
a
pesticide
fails
to
submit
the
information
required
by
paragraph
(
1)
within
the
time
prescribed
by
paragraph
(
2),
the
Administrator,
by
order
and
without
hearing,
shall
cancel
the
registration
of
such
pesticide.
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
nonfood
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
nonfood
uses
of
the
pesticide,
the
Administrator,
at
the
written
request
of
the
registrant,
shall
not
take
any
action
pursuant
to
this
subparagraph
in
regard
to
such
unsupported
minor
use
until
the
final
deadline
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996
for
the
submission
of
data
under
this
section
for
the
supported
uses
identified
pursuant
to
this
subparagraph
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
may
refuse
the
request
for
extension
by
the
registrant.
Upon
receipt
of
the
request
from
the
registrant,
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
subparagraph,
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
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
section
3(
c)(
2)(
B)(
iv)
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
this
subparagraph,
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
effect
on
the
environment.
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
37
of
65
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.

(
B)(
i)
If
the
registrant
of
a
pesticide
submits
the
information
required
by
paragraph
(
1)
within
the
time
prescribed
by
paragraph
(
2)
and
such
information
does
not
conform
to
the
guidelines
for
submissions
established
by
the
Administrator,
the
Administrator
shall
determine
whether
the
registrant
made
a
good
faith
attempt
to
conform
its
submission
to
such
guidelines.

(
ii)
If
the
Administrator
determines
that
the
registrant
made
a
good
faith
attempt
to
conform
its
submission
to
such
guidelines,
the
Administrator
shall
provide
the
registrant
a
reasonable
period
of
time
to
make
any
necessary
changes
or
corrections.

(
iii)(
I)
If
the
Administrator
determines
that
the
registrant
did
not
make
a
good
faith
attempt
to
conform
its
submission
to
such
guidelines,
the
Administrator
may
issue
a
notice
of
intent
to
cancel
the
registration.
Such
a
notice
shall
be
sent
to
the
registrant
by
certified
mail.

(
II)
The
registration
shall
be
canceled
without
a
hearing
or
further
notice
at
the
end
of
30
days
after
receipt
by
the
registrant
of
the
notice
unless
during
that
time
a
request
for
a
hearing
is
made
by
the
registrant.

(
III)
If
a
hearing
is
requested,
a
hearing
shall
be
conducted
under
section
6(
d),
except
that
the
only
matter
for
resolution
at
the
hearing
shall
be
whether
the
registrant
made
a
good
faith
attempt
to
conform
its
submission
to
such
guidelines.
The
hearing
shall
be
held
and
a
determination
made
within
75
days
after
receipt
of
a
request
for
hearing.

(
4)
Guidelines.­­

(
A)
Not
later
than
one
year
after
the
effective
date
of
this
section,
the
Administrator,
by
order,
shall
issue
guidelines
to
be
followed
by
registrants
in
 
(
i)
summarizing
studies;

(
ii)
reformatting
studies;

(
iii)
identifying
adverse
information;
and
(
iv)
identifying
studies
that
have
been
submitted
previously
that
may
not
meet
the
requirements
of
section
3
or
regulations
issued
under
such
section,
under
paragraph
(
1).

(
B)
Guidelines
issued
under
subparagraph
(
A)
shall
not
be
subject
to
judicial
review.

(
5)
Monitoring.­­
The
Administrator
shall
monitor
the
progress
of
registrants
in
acquiring
and
submitting
the
data
required
under
paragraph
(
1).
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
38
of
65
(
f)
Phase
Four.­­

(
1)
Independent
Review
and
Identification
of
Outstanding
Data
Requirements.­­

(
A)
The
Administrator
shall
review
the
submissions
of
all
registrants
of
pesticides
containing
a
particular
active
ingredient
under
subsections
(
d)(
3)
and
(
e)(
1)
to
determine
if
such
submissions
identified
all
the
data
that
are
missing
or
inadequate
for
such
active
ingredient.
To
assist
the
review
of
the
Administrator
under
this
subparagraph,
the
Administrator
may
require
a
registrant
seeking
reregistration
to
submit
complete
copies
of
studies
summarized
under
subsection
(
e)(
1).

(
B)
The
Administrator
shall
independently
identify
and
publish
in
the
Federal
Register
the
outstanding
data
requirements
for
each
active
ingredient
that
is
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
and
that
is
contained
in
a
pesticide
to
be
reregistered
under
this
section.
The
Administrator,
at
the
same
time,
shall
issue
a
notice
under
section
3(
c)(
2)(
B)
for
the
submission
of
the
additional
data
that
are
required
to
meet
such
requirements.

(
2)
Time
Periods.­­

(
A)
The
Administrator
shall
take
the
action
required
by
paragraph
(
1)­­

(
i)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
B),
not
later
than
18
months
after
the
date
of
the
listing
of
such
active
ingredient;

(
ii)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
C),
not
later
than
24
months
after
the
date
of
the
listing
of
such
active
ingredient;
and
(
iii)
in
the
case
of
a
pesticide
containing
an
active
ingredient
listed
under
subsection
(
c)(
2)(
D),
not
later
than
three
months
after
the
date
of
the
listing
of
such
active
ingredient.

(
B)
If
the
Administrator
issues
a
notice
to
a
registrant
under
paragraph
(
1)(
B)
for
the
submission
of
additional
data,
the
registrant
shall
submit
such
data
within
a
reasonable
period
of
time,
as
determined
by
the
Administrator,
but
not
to
exceed
48
months
after
the
issuance
of
such
notice.
The
Administrator,
on
application
of
a
registrant,
may
extend
the
period
prescribed
by
the
preceding
sentence
by
no
more
than
2
two
years
if
extraordinary
circumstances
beyond
the
control
of
the
registrant
prevent
the
registrant
from
submitting
data
within
such
prescribed
period.

Upon
application
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
this
section
for
the
other
uses
of
the
pesticide
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996
if
 
(
i)
the
data
to
support
other
uses
of
the
pesticide
on
a
food
are
being
provided;
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
39
of
65
(
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
this
section;
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
subparagraph,
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)
of
section
3(
c)(
2)(
B)
or
other
provisions
of
this
section,
as
appropriate,
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
subparagraph,
the
Administrator
may
take
action
to
modify
or
revoke
the
extension
under
this
subparagraph
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
written
notice
to
the
registrant
revoking
the
extension
of
time
for
submission
of
data.
Such
data
shall
instead
be
due
in
accordance
with
the
date
then
established
by
the
Administrator
for
submission
of
the
data.

(
3)
Suspensions
and
Penalties.­­
The
Administrator
shall
issue
a
notice
of
intent
to
suspend
the
registration
of
a
pesticide
in
accordance
with
the
procedures
prescribed
by
section
3(
c)(
2)(
B)(
iv)
if
the
Administrator
determines
that
(
A)
tests
necessary
to
fill
an
outstanding
data
requirement
for
such
pesticide
have
not
been
initiated
within
one
year
after
the
issuance
of
a
notice
under
paragraph
(
1)(
B),
or
(
B)
progress
is
insufficient
to
ensure
submission
of
the
data
referred
to
in
clause
(
A)
within
the
time
period
prescribed
by
paragraph
(
2)(
B)
or
the
required
data
have
not
been
submitted
to
the
Administrator
within
such
time
period.
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
nonfood
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
nonfood
uses
of
the
pesticide,
the
Administrator,
at
the
written
request
of
the
registrant,
shall
not
take
any
action
pursuant
to
this
paragraph
in
regard
to
such
unsupported
minor
use
until
the
final
deadline
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996,
for
the
submission
of
data
under
this
section
for
the
supported
uses
identified
pursuant
to
this
paragraph
unless
the
Administrator
determines
that
the
absence
of
the
data
is
significant
enough
to
cause
human
health
or
environmental
concerns.
On
such
a
determination
the
Administrator
may
refuse
the
request
for
extension
by
the
registrant.
Upon
receipt
of
the
request
from
the
registrant,
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
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
40
of
65
registration
pursuant
to
section
6(
f)(
1).
If
the
Administrator
grants
an
extension
under
this
paragraph,
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
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
section
3(
c)(
2)(
B)(
iv)
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
this
subparagraph,
the
Administrator
may
deny,
modify,
or
revoke
the
temporary
extension
under
this
paragraph
if
the
Administrator
determines
that
the
continuation
of
the
minor
use
may
cause
an
unreasonable
adverse
effect
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.

(
g)
Phase
Five.­­

(
1)
Data
Review.­­
The
Administrator
shall
conduct
a
thorough
examination
of
all
data
submitted
under
this
section
concerning
an
active
ingredient
listed
under
subsection
(
c)(
2)
of
this
section
and
of
all
other
available
data
found
by
the
Administrator
to
be
relevant.

(
2)
Reregistration
and
Other
Actions
 
(
A)
Within
one
year
after
the
submission
of
all
data
concerning
an
active
ingredient
of
a
pesticide
under
subsection
(
f),
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration.
For
extraordinary
circumstances,
the
Administrator
may
extend
such
period
for
not
more
than
1
additional
year.

(
B)
Before
reregistering
a
pesticide,
the
Administrator
shall
obtain
any
needed
product­
specific
data
regarding
the
pesticide
by
use
of
section
3(
c)(
2)(
B)
and
shall
review
such
data
within
90
days
after
its
submission.
The
Administrator
shall
require
that
data
under
this
subparagraph
be
submitted
to
the
Administrator
not
later
than
8
months
after
a
determination
of
eligibility
under
subparagraph
(
A)
has
been
made
for
each
active
ingredient
of
the
pesticide,
unless
the
Administrator
determines
that
a
longer
period
is
required
for
the
generation
of
the
data.

(
C)
After
conducting
the
review
required
by
paragraph
(
1)
for
each
active
ingredient
of
a
pesticide
and
the
review
required
by
subparagraph
(
B)
of
this
paragraph,
the
Administrator
shall
determine
whether
to
reregister
a
pesticide
by
determining
whether
such
pesticide
meets
the
requirements
of
section
3(
c)(
5).
If
the
Administrator
determines
that
a
pesticide
is
eligible
to
be
reregistered,
the
Administrator
shall
reregister
such
pesticide
within
6
months
after
the
submission
of
the
data
concerning
such
pesticide
under
subparagraph
(
B).

(
D)
If
after
conducting
a
review
under
paragraph
(
1)
or
subparagraph
(
B)
of
this
paragraph
the
Administrator
determines
that
a
pesticide
should
not
be
reregistered,
the
Administrator
shall
take
appropriate
regulatory
action.
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
41
of
65
(
E)
As
soon
as
the
Administrator
has
sufficient
information
with
respect
to
the
dietary
risk
of
a
particular
active
ingredient,
but
in
any
event
no
later
than
the
time
the
Administrator
makes
a
determination
under
subparagraph
(
C)
or
(
D)
with
respect
to
pesticides
containing
a
particular
active
ingredient,
the
Administrator
shall
 
(
i)
reassess
each
associated
tolerance
and
exemption
from
the
requirement
for
a
tolerance
issued
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
21
U.
S.
C.
346a);

(
ii)
determine
whether
such
tolerance
or
exemption
meets
the
requirements
of
that
Act;

(
iii)
determine
whether
additional
tolerances
or
exemptions
should
be
issued;

(
iv)
publish
in
the
Federal
Register
a
notice
setting
forth
the
determinations
made
under
this
subparagraph;
and
(
v)
commence
promptly
such
proceedings
under
this
Act
and
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
as
are
warranted
by
such
determinations.

(
h)
Compensation
of
Data
Submitter.­­
If
data
that
are
submitted
by
a
registrant
under
subsection
(
d),
(
e),
(
f),
or
(
g)
of
this
section
are
used
to
support
the
application
of
another
person
under
section
136a
of
this
title,
the
registrant
who
submitted
such
data
shall
be
entitled
to
compensation
for
the
use
of
such
data
as
prescribed
by
section
136a(
c)(
1)(
D)
\
2\
of
this
title.
In
determining
the
amount
of
such
compensation,
the
fees
paid
by
the
registrant
under
this
section
shall
be
taken
into
account.

(
i)
Fees.­­

(
1)
Initial
Fee
for
Food
or
Feed
Use
Pesticide
Active
Ingredients.
 
The
registrants
of
pesticides
that
contain
an
active
ingredient
that
is
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
of
this
section
and
that
is
an
active
ingredient
of
any
pesticide
registered
for
a
major
food
or
feed
use
shall
collectively
pay
a
fee
of
$
50,000
on
submission
of
information
under
paragraphs
(
2)
and
(
3)
of
subsection
(
d)
of
this
section
for
such
ingredient.

(
2)
Final
Fee
for
Food
or
Feed
Use
Pesticide
Active
Ingredients
 
(
A)
The
registrants
of
pesticides
that
contain
an
active
ingredient
that
is
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
and
that
is
an
active
ingredient
of
any
pesticide
registered
for
a
major
food
or
feed
use
shall
collectively
pay
a
fee
of
$
100,000­­

(
i)
on
submission
of
information
for
such
ingredient
under
subsection
(
e)(
1)
if
data
are
reformatted
under
subsection
(
e)(
1)(
C);
or
(
ii)
on
submission
of
data
for
such
ingredient
under
subsection
(
e)(
2)(
B)
if
data
are
not
reformatted
under
subsection
(
e)(
1)(
C).
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
42
of
65
(
B)
The
registrants
of
pesticides
that
contain
an
active
ingredient
that
is
listed
under
subsection
(
c)(
2)(
A)
and
that
is
an
active
ingredient
of
any
pesticide
registered
for
a
major
food
or
feed
use
shall
collectively
pay
a
fee
of
$
150,000
at
such
time
as
the
Administrator
shall
prescribe.

(
3)
Fees
for
Other
Pesticide
Active
Ingredients.

(
A)
The
registrants
of
pesticides
that
contain
an
active
ingredient
that
is
listed
under
subparagraph
(
B),
(
C),
or
(
D)
of
subsection
(
c)(
2)
and
that
is
not
an
active
ingredient
of
any
pesticide
registered
for
a
major
food
or
feed
use
shall
collectively
pay
fees
in
amounts
determined
by
the
Administrator.
Such
fees
may
not
be
less
than
one­
half
of,
nor
greater
than,
the
fees
required
by
paragraphs
(
1)
and
(
2).
A
registrant
shall
pay
such
fees
at
the
times
corresponding
to
the
times
fees
prescribed
by
paragraphs
(
1)
and
(
2)
are
to
be
paid.

(
B)
The
registrants
of
pesticides
that
contain
an
active
ingredient
that
is
listed
under
subsection
(
c)(
2)(
A)
and
that
is
not
an
active
ingredient
of
any
pesticide
that
is
registered
for
a
major
food
or
feed
use
shall
collectively
pay
a
fee
of
not
more
than
$
100,000
and
not
less
than
$
50,000
at
such
time
as
the
Administrator
shall
prescribe.

(
4)
Reduction
or
Waiver
of
Fees
for
Minor
Use
and
Other
Pesticides.

(
A)
An
active
ingredient
that
is
contained
only
in
pesticides
that
are
registered
solely
for
agricultural
or
nonagricultural
minor
uses,
or
a
pesticide
the
value
or
volume
of
use
of
which
is
small,
shall
be
exempt
from
the
fees
prescribed
by
paragraph
(
3).

(
B)
The
Administrator
shall
exempt
any
public
health
pesticide
from
the
payment
of
the
fee
prescribed
under
paragraph
(
3)
if,
in
consultation
with
the
Secretary
of
Health
and
Human
Services,
the
Administrator
determines,
based
on
information
supplied
by
the
registrant,
that
the
economic
return
to
the
registrant
from
sales
of
the
pesticide
does
not
support
the
registration
or
reregistration
of
the
pesticide.

(
C)
An
antimicrobial
active
ingredient,
the
production
level
of
which
does
not
exceed
1,000,000
pounds
per
year,
shall
be
exempt
from
the
fees
prescribed
by
paragraph
(
3).
For
purposes
of
this
subparagraph,
the
term
"
antimicrobial
active
ingredient"
means
any
active
ingredient
that
is
contained
only
in
pesticides
that
are
not
registered
for
any
food
or
feed
use
and
that
are
 
(
i)
sanitizers
intended
to
reduce
the
number
of
living
bacteria
or
viable
virus
particles
on
inanimate
surface
or
in
water
or
air;

(
ii)
bacteriostats
intended
to
inhibit
the
growth
of
bacteria
in
the
presence
of
moisture;

(
iii)
disinfectants
intended
to
destroy
or
irreversibly
inactivate
bacteria,
fungi,
or
viruses
on
surfaces
or
inanimate
objects;
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
43
of
65
(
iv)
sterilizers
intended
to
destroy
viruses
and
all
living
bacteria,
fungi,
and
their
spores
on
inanimate
surfaces;
or
(
v)
fungicides
or
fungistats.

(
D)(
i)
Notwithstanding
any
other
provision
of
this
subsection,
in
the
case
of
a
small
business
registrant
of
a
pesticide,
the
registrant
shall
pay
a
fee
for
the
reregistration
of
each
active
ingredient
of
the
pesticide
that
does
not
exceed
an
amount
determined
in
accordance
with
this
subparagraph.

(
ii)
If
during
the
3­
year
period
prior
to
reregistration
the
average
annual
gross
revenue
of
the
registrant
from
pesticides
containing
such
active
ingredient
is
 
(
I)
less
than
$
5,000,000,
the
registrant
shall
pay
0.5
percent
of
such
revenue;

(
II)
$
5,000,000
or
more
but
less
than
$
10,000,000,
the
registrant
shall
pay
1
percent
of
such
revenue;
or
(
III)
$
10,000,000
or
more,
the
registrant
shall
pay
1.5
percent
of
such
revenue,
but
not
more
than
$
150,000.

(
iii)
For
the
purpose
of
this
subparagraph,
a
small
business
registrant
is
a
corporation,
partnership,
or
unincorporated
business
that
 
(
I)
has
150
or
fewer
employees;
and
(
II)
during
the
3­
year
period
prior
to
reregistration,
had
an
average
annual
gross
revenue
from
chemicals
that
did
not
exceed
$
40,000,000.

(
5)
Maintenance
Fee.­­

(
A)
Subject
to
other
provisions
of
this
paragraph,
each
registrant
of
a
pesticide
shall
pay
an
annual
fee
by
January
15
of
each
year
of
 
(
i)
$
650
for
the
first
registration;
and
(
ii)
$
1,300
for
each
additional
registration,
except
that
no
fee
shall
be
charged
for
more
than
200
registrations
held
by
any
registrant.

(
B)
In
the
case
of
a
pesticide
that
is
registered
for
a
minor
agricultural
use,
the
Administrator
may
reduce
or
waive
the
payment
of
the
fee
imposed
under
this
paragraph
if
the
Administrator
determines
that
the
fee
would
significantly
reduce
the
availability
of
the
pesticide
for
the
use.
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
44
of
65
(
C)(
i)
The
amount
of
each
fee
prescribed
under
subparagraph
(
A)
shall
be
adjusted
by
the
Administrator
to
a
level
that
will
result
in
the
collection
under
this
paragraph
of,
to
the
extent
practicable,
an
aggregate
amount
of
$
14,000,000
each
fiscal
year.

(
ii)
in
each
of
the
fiscal
years
1998,
1999,
and
2000,
the
Administrator
is
authorized
to
collect
up
to
an
additional
$
2,000,000
in
a
manner
consistent
with
subsection
(
k)(
5)
and
the
recommendations
of
the
Inspector
General
of
the
Environmental
Protection
Agency.
The
total
fees
that
may
be
collected
under
this
clause
shall
not
exceed
$
6,000,000.

(
D)
The
maximum
annual
fee
payable
under
this
paragraph
by
 
(
i)
a
registrant
holding
not
more
than
50
pesticide
registrations
shall
be
$
55,000;
and
(
ii)
a
registrant
holding
over
50
registrations
shall
be
$
95,000.

(
E)(
i)
For
a
small
business,
the
maximum
annual
fee
payable
under
this
paragraph
by­­

(
I)
a
registrant
holding
not
more
than
50
pesticide
registrations
shall
be
$
38,500;
and
(
II)
a
registrant
holding
over
50
pesticide
registrations
shall
be
$
66,500.

(
ii)
For
purposes
of
clause
(
i),
the
term
"
small
business"
means
a
corporation,
partnership,
or
unincorporated
business
that
 
(
I)
has
150
or
fewer
employees;
and
(
II)
during
the
3­
year
period
prior
to
the
most
recent
maintenance
fee
billing
cycle,
had
an
average
annual
gross
revenue
from
chemicals
that
did
not
exceed
$
40,000,000.

(
F)
The
Administrator
shall
exempt
any
public
health
pesticide
from
the
payment
of
the
fee
prescribed
under
paragraph
(
3)
if,
in
consultation
with
the
Secretary
of
Health
and
Human
Services,
the
Administrator
determines,
based
on
information
supplied
with
the
registrant,
that
the
economic
return
to
the
registrant
from
sales
of
the
pesticide
does
not
support
the
registration
or
reregistration
of
the
pesticide.

(
G)
If
any
fee
prescribed
by
this
paragraph
with
respect
to
the
registration
of
a
pesticide
is
not
paid
by
a
registrant
by
the
time
prescribed,
the
Administrator,
by
order
and
without
hearing,
may
cancel
the
registration.

(
H)
The
authority
provided
under
this
paragraph
shall
terminate
on
September
30,
2001.

(
6)
Other
Fees.­­
During
the
period
beginning
on
October
25,
1988,
and
ending
on
September
30,
2001,
the
Administrator
may
not
levy
any
other
fees
for
the
registration
of
a
pesticide
under
this
Act
except
as
provided
in
paragraphs
(
1)
through
(
5).
Attachment
A
­
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Section
4
­
Reregistration
of
Registered
Pesticides
Page
45
of
65
(
7)
Apportionment.­­

(
A)
If
two
or
more
registrants
are
required
to
pay
any
fee
prescribed
by
paragraph
(
1),
(
2),
or
(
3)
with
respect
to
a
particular
active
ingredient,
the
fees
for
such
active
ingredient
shall
be
apportioned
among
such
registrants
on
the
basis
of
the
market
share
in
United
States
sales
of
the
active
ingredient
for
the
3
calendar
years
preceding
the
date
of
payment
of
such
fee,
except
that
 
(
i)
small
business
registrants
that
produce
the
active
ingredient
shall
pay
fees
in
accordance
with
paragraph
(
4)(
C);
and
(
ii)
registrants
who
have
no
market
share
but
who
choose
to
reregister
a
pesticide
containing
such
active
ingredient
shall
pay
the
lesser
of
 
(
I)
15
percent
of
the
reregistration
fee;
or
(
II)
a
proportionate
amount
of
such
fee
based
on
the
lowest
percentage
market
share
held
by
any
registrant
active
in
the
marketplace.
In
no
event
shall
registrants
who
have
no
market
share
but
who
choose
to
reregister
a
pesticide
containing
such
active
ingredient
collectively
pay
more
than
25
percent
of
the
total
active
ingredient
reregistration
fee.

(
B)
The
Administrator,
by
order,
may
require
any
registrant
to
submit
such
reports
as
the
Administrator
determines
to
be
necessary
to
allow
the
Administrator
to
determine
and
apportion
fees
under
this
subsection
or
to
determine
the
registrant's
eligibility
for
a
reduction
or
waiver
of
a
fee,
or
to
determine
the
volume
usage
for
public
health
pesticides.

(
C)
If
any
such
report
is
not
submitted
by
a
registrant
after
receiving
notice
of
such
report
requirement,
or
if
any
fee
prescribed
by
this
subsection
(
other
than
paragraph
(
5))
for
an
active
ingredient
is
not
paid
by
a
registrant
to
the
Administrator
by
the
time
prescribed
under
this
subsection,
the
Administrator,
by
order
and
without
hearing,
may
cancel
each
registration
held
by
such
registrant
of
a
pesticide
containing
the
active
ingredient
with
respect
to
which
the
fee
is
imposed.
The
Administrator
shall
reapportion
the
fee
among
the
remaining
registrants
and
notify
the
registrants
that
the
registrants
are
required
to
pay
to
the
Administrator
any
unpaid
balance
of
the
fee
within
30
days
after
receipt
of
such
notice.

(
j)
Exemption
of
Certain
Registrants.
 
The
requirements
of
subsections
(
d),
(
e),
(
f),
and
(
i)
of
this
section
(
other
than
subsection
(
i)(
5)
of
this
section)
regarding
data
concerning
an
active
ingredient
and
fees
for
review
of
such
data
shall
not
apply
to
any
person
who
is
the
registrant
of
a
pesticide
to
the
extent
that,
under
section
3(
c)(
2)(
D),
the
person
would
not
be
required
to
submit
or
cite
such
data
to
obtain
an
initial
registration
of
such
pesticide.
Page
46
of
65
ATTACHMENT
B
­
FIFRA
Section
3(
c)(
2)(
B)

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.
Page
47
of
65
(
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
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.
Page
48
of
65
(
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
 
(
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
Page
49
of
65
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
 
(
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.
Page
50
of
65
Page
51
of
65
Page
52
of
65
Page
53
of
65
Page
54
of
65
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:

1)
Read
DCI
&
test
requirements
(
includes
review
of
records
for
previously
unavailable
data
&
requesting
exemptions
or
waivers)

2)
Discuss
test
and
protocol
with
Agency
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
Page
55
of
65
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
over­
estimate
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
conducted
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.

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
of
that
consortium.
However,
for
purposes
of
this
ICR,
EPA
estimates
are
on
a
per­
registrant
basis,
without
considering
this
possibility
for
sharing
the
burden.

Basically
two
types
of
respondent
burden
are
considered
in
deriving
the
burden
estimates:
Administrative
Burden
and
Technical
Burden.
The
respondents'
Administrative
Burden
is
defined
as
the
time
spent
communicating
and
working
with
the
Agency
to
develop
and
agree
upon
data
requirements,
the
protocol,
the
field
site,
and
data
presentations,
and
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.

To
derive
the
Administrative
Burden,
the
Agency
estimated
the
amount
of
administrative
labor
cost
that
would
be
in
addition
to
the
total
test
cost
using
a
percentage
of
the
total
test
costs.
The
Agency
assumed
that
respondents
would
expend
approximately
two
percent
2
This
percentage
represents
an
estimate
obtained
from
expert
opinion,
industry
sources,
and
proprietary
data.

3This
estimate
was
derived
from
an
assessment
of
the
test
data
cost
estimates
by
DPRA,
Inc.;
subcontract
with
W.
R.
Landis
Associates,
Inc.

4The
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.

5
Same
as
Footnote
2.

6
Same
as
Footnote
2.

Page
56
of
65
of
the
total
cost
for
Administrative
Burden.
2
The
Agency
assumed
that
the
value
of
this
time
is
divided
proportionally
among
management
(
20%),
technical
staff
(
65%)
and
clerical
(
15%).
3
The
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
130,
$
88,
and
$
40,
respectively.
4
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.
5
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.

Since
it
is
anticipated
that
actual
DCI
requests
per
year
will
vary,
the
annual
estimated
burden
and
costs
is
distributed
evenly
across
the
three
year
duration
of
the
ICR
to
estimate
an
average
annual
burden
and
cost.

3.
How
did
EPA
estimate
the
potential
Respondent
paperwork
cost?

As
was
the
case
for
the
burden
hour
analysis
discussed
above,
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
Administrative
Costs
are
estimated
as
approximately
two
percent
of
the
total
test
cost
and
are
considered
additive
costs,
while
the
Technical
Costs
are
based
on
the
assumption
that
one­
third
of
the
total
test
cost
represents
labor
cost.
6
The
value
of
labor
is
divided
proportionally
among
management
(
20%),
technical
staff
(
65%)
and
clerical
(
15%).
The
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
130,
$
88,
and
$
40,
respectively.

The
Agency
also
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.
Page
57
of
65
ATTACHMENT
H
ATTACHMENT
H
ICR
for
Reregistration
Program:
List
of
RED/
IRED,
TRED,
and
Import
Tolerance
Pesticide
Candidates
Estimated
To
Have
DCI
Needs
RED/
IRED,
TRED,
and
Import
Tolerance
candidates
are
listed
by
the
Fiscal
Year
(
FY)
of
their
anticipated
signature
completion
dates
and
are
subject
to
change.
Reregistration
actions
completed
during
FYs
2004­
2006
are
assumed
to
have
their
DCIs
issued
during
FYs
2005­
2007.

A.
Summary
of
Reregistration
Actions
1.
FY
2004
RED/
IRED
Candidates
=
18
2.
FY
2004
TRED
Candidates
=
19
3.
FY
2005
RED/
IRED
Candidates
=
39
4.
FY
2005
TRED
Candidates
=
11
5.
FY
2006
RED/
IRED
Candidates
=
34
6.
FY
2006
TRED
Candidates
=
18
7.
Import
Tolerance
Candidates
=
3
­­­­­­­­­
Total
=
142
B.
Anticipated
Decision
Document
Signature
Completion
FY2004
RED/
IRED
Candidates:
N
Case
Name
5)
2030
Benfluralin
6)
3026
Benzisothiazolin­
3­
one
(
Proxel)
7)
0012
Carboxin
8)
2125
Cycloate
9)
3055
Dihalodialkylhydantoins
10)
0003
Ethoxyquin
11)
0091
Formetanate
HCl
(
as
an
IRED)
12)
0017
MCPA
13)
0183
Naptalam
10.
0379
Napthaleneacetic
Acid
11.
4069
Oleic
acid
sulfonates
12.
2480
Omadine
salts
13.
4074
Phenol,
and
salts
14.
3113
Pine
oils
15.
3122
Poly(
hexamethylenebiguanide)
or
PHMB
16.
3126
Propylene
glycol
17.
3128
Sabadilla
alkaloids
18.
0122
Thiram
FY2004
TRED
Candidates:
N
Name
1.
Amitraz
2.
Bacillus
thuringiensis
var.
San
Diego
3.
Boric
acid
Group
Page
58
of
65
4.
Carbon
dioxide
5.
Chlorimuron
ethyl
6.
DCPA
7.
Desmedipham
8.
Dimethenamid
9.
Flumetsulam
10.
Fluridone
11.
Limonene
12.
Nitrogen
13.
Oil
of
Lemon
14.
Oil
of
Orange
15.
Oryzalin
16.
Putrescent
whole
egg
solids
17.
Thifensulfuron­
methyl
18.
Tribenuron
methyl
19.
Trifluralin
FY2005
RED/
IRED
Candidates:
N
Case
Name
1.
2030
Benfluralin
2.
0073
2,4­
D
3.
0196
2,4­
DB
4.
2575
2­
Phenylphenol,
and
salts
5.
2010
Ametryn
6.
4010
Aquashade
(*)
7.
3023
Azadioxabicyclooctane
8.
4013
Benzoic
acid,
and
derivs
9.
2080
Cacodylic
acid,
and
salts
10.
4023
Chlorine
dioxide
(
includes
sodium
chlorite)
11.
0007
Chloroneb
12.
0631
Chlorsulfuron
13.
0132
Chromated
arsenicals
14.
0139
Coal
Tar/
Creosote
15.
0310
DDVP
(
dichlorvos)
(
as
an
IRED)
16.
3063
Dimethipin
17.
0088
Dimethoate
(
as
an
IRED)
2180
Dimethyldithiocarbamate
salts
(
rest
of
case,
Ziram
completed
in
FY2003,
not
to
be
re­
counted
as
a
RED
in
order
to
avoid
duplicate
RED
count,
but
DCIs
may
need
to
be
issued)
18.
2245
Endothall
and
salts
19.
2265
Ethofumesate
20.
0049
Fluometuron
21.
4049
Inorg.
chlorates
22.
3080
Iodine,
KI,
and
23.
0248
Malathion
(
as
an
IRED)
24.
0643
Mancozeb
25.
0642
Maneb
26.
2395
Methanearsonic
acid,
salts
(
MSMA,
DSMA,
and
CAMA)
Page
59
of
65
27.
0335
Methyl
bromide
28.
2405
Methyl
isothiocyanate
(
MITC)
29.
2390
Methyldithiocarbamate
salts
30.
0644
Metiram
31.
2450
Napropamide
32.
0213
Nitrapyrin
33.
0128
PCNB
34.
2505
Pentachlorophenol
35.
0277
Phenmedipham
36.
4105
Phytophthora
citrophthora
(
See
Phytophthora
palmivora)
37.
2570
Pyrazon
38.
3132
Sodium
fluoride
39.
4092
Thidiazuron
FY2005
TRED
Candidates:
N
Name
1.
Burkholderia
cepacia
2.
Cyhexatin
3.
Ethephon
4.
Fluazifop­
p­
butyl
5.
Flumiclorac­
pentyl
6.
Imazethabenz
7.
Maleic
hydrazide
8.
Methyl
eugenol
9.
Nicosulfuron
10.
Sulfuric
acid
monourea
11.
Tanol
derivitives
FY2006
RED/
IRED
Candidates:
N
Case
Name
1.
0140
Aldicarb
(
as
an
IRED)
2.
3004
Aliphatic
solvents
3.
3020
Aromatic
solvents
4.
3021
Arsenal
(*)
(
Imazapyr)
5.
0101
Carbofuran
(
as
an
IRED)
6.
0040
Chloropicrin
7.
0649
Copper
compounds:
Grp
II
8.
0636
Copper
sulfate
9.
4025
Copper,
and
oxides
10.
2130
Cypermethrin
11.
0113
DCNA
12.
0065
Dicamba
13.
0161
Dodine
14.
2275
Ethylene
oxide
15.
2295
Fluvalinate
16.
0556
Formaldehyde
17.
4054
Inorg.
polysulfides
18.
4056
Inorg.
sulfites
19.
2365
MCPB,
and
salts
Page
60
of
65
20.
0576
Metaldehyde
21.
2430
MGK­
264
(*)
22.
3099
Naphthenate
salts
23.
2510
Permethrin
24.
2525
Piperonyl
butoxide
25.
3125
Propiconazole
26.
2560
Propylene
oxide
27.
2580
Pyrethrin,
and
derivs
28.
0421
Resmethrin
29.
0255
Rotenone
30.
4080
Salicylic
acid,
and
derivs
31.
2600
Sethoxydim
32.
0070
Simazine
(
as
an
IRED)
33.
2625
TCMB
34.
2700
Tridimefon
FY2006
TRED
Candidates:
N
Name
1.
Acetochlor
2.
Ammonia
3.
Azadirachitin
4.
Benzaldehyde
5.
Bitertanol
6.
Bromine
7.
Ethalfluralin
8.
Fomesafen
9.
Imazaquin
10.
Menthol
11.
Oxytetracycline
12.
Procymidone
13.
Propazine
14.
Sodium
Cyanide
(
hydrocyanic
acid)
15.
Streptomycin
16.
Tetradifon
17.
Triadimenol
18.
Tridemorph
Import
Tolerance
Candidates:
There
are
three
known
pesticide
ingredients
which
have
no
active
U.
S.
registrations,
but
have
import
tolerances
and
are
subject
to
DCIs
as
needed.
EPA
has
published
guidance
on
how
to
adapt
data
requirements
for
U.
S.
food
uses
to
import
tolerances
(
65
FR
35069,
June
1,
2000)
(
FRL­
6559­
3).

N
Name
1.
Cadusafos
2.
Mevinphos
3.
Phosalone
Page
61
of
65
(*)
Indicates
use
of
trade
name
as
case
name
in
place
of
a
long
chemical
name
for
most
of
these.

ICR
for
Reregistration
Program:
List
of
RED/
IRED,
TRED,
and
Import
Tolerance
Pesticide
Candidates
Estimated
To
Have
DCI
Needs
RED/
IRED,
TRED,
and
Import
Tolerance
candidates
are
listed
by
the
Fiscal
Year
(
FY)
of
their
anticipated
signature
completion
dates
and
are
subject
to
change.
Reregistration
actions
completed
during
FYs
2004­
2006
are
assumed
to
have
their
DCIs
issued
during
FYs
2005­
2007.

A.
Summary
of
Reregistration
Actions
1.
FY
2004
RED/
IRED
Candidates
=
18
2.
FY
2004
TRED
Candidates
=
19
3.
FY
2005
RED/
IRED
Candidates
=
39
4.
FY
2005
TRED
Candidates
=
11
5.
FY
2006
RED/
IRED
Candidates
=
34
6.
FY
2006
TRED
Candidates
=
18
7.
Import
Tolerance
Candidates
=
3
­­­­­­­­­
Total
=
142
B.
Anticipated
Decision
Document
Signature
Completion
FY2004
RED/
IRED
Candidates:
N
Case
Name
4.
2030
Benfluralin
5.
3026
Benzisothiazolin­
3­
one
(
Proxel)
6.
0012
Carboxin
7.
2125
Cycloate
8.
3055
Dihalodialkylhydantoins
9.
0003
Ethoxyquin
10.
0091
Formetanate
HCl
(
as
an
IRED)
11.
0017
MCPA
12.
0183
Naptalam
10.
0379
Napthaleneacetic
Acid
11.
4069
Oleic
acid
sulfonates
12.
2480
Omadine
salts
13.
4074
Phenol,
and
salts
14.
3113
Pine
oils
15.
3122
Poly(
hexamethylenebiguanide)
or
PHMB
16.
3126
Propylene
glycol
17.
3128
Sabadilla
alkaloids
18.
0122
Thiram
FY2004
TRED
Candidates:
N
Name
1.
Amitraz
2.
Bacillus
thuringiensis
var.
San
Diego
Page
62
of
65
3.
Boric
acid
Group
4.
Carbon
dioxide
5.
Chlorimuron
ethyl
6.
DCPA
7.
Desmedipham
8.
Dimethenamid
9.
Flumetsulam
10.
Fluridone
11.
Limonene
12.
Nitrogen
13.
Oil
of
Lemon
14.
Oil
of
Orange
15.
Oryzalin
16.
Putrescent
whole
egg
solids
17.
Thifensulfuron­
methyl
18.
Tribenuron
methyl
19.
Trifluralin
FY2005
RED/
IRED
Candidates:
N
Case
Name
1.
2030
Benfluralin
2.
0073
2,4­
D
3.
0196
2,4­
DB
4.
2575
2­
Phenylphenol,
and
salts
5.
2010
Ametryn
6.
4010
Aquashade
(*)
7.
3023
Azadioxabicyclooctane
8.
4013
Benzoic
acid,
and
derivs
9.
2080
Cacodylic
acid,
and
salts
10.
4023
Chlorine
dioxide
(
includes
sodium
chlorite)
11.
0007
Chloroneb
12.
0631
Chlorsulfuron
13.
0132
Chromated
arsenicals
14.
0139
Coal
Tar/
Creosote
15.
0310
DDVP
(
dichlorvos)
(
as
an
IRED)
16.
3063
Dimethipin
17.
0088
Dimethoate
(
as
an
IRED)
2180
Dimethyldithiocarbamate
salts
(
rest
of
case,
Ziram
completed
in
FY2003,
not
to
be
re­
counted
as
a
RED
in
order
to
avoid
duplicate
RED
count,
but
DCIs
may
need
to
be
issued)
18.
2245
Endothall
and
salts
19.
2265
Ethofumesate
20.
0049
Fluometuron
21.
4049
Inorg.
chlorates
22.
3080
Iodine,
KI,
and
23.
0248
Malathion
(
as
an
IRED)
24.
0643
Mancozeb
25.
0642
Maneb
Page
63
of
65
26.
2395
Methanearsonic
acid,
salts
(
MSMA,
DSMA,
and
CAMA)
27.
0335
Methyl
bromide
28.
2405
Methyl
isothiocyanate
(
MITC)
29.
2390
Methyldithiocarbamate
salts
30.
0644
Metiram
31.
2450
Napropamide
32.
0213
Nitrapyrin
33.
0128
PCNB
34.
2505
Pentachlorophenol
35.
0277
Phenmedipham
36.
4105
Phytophthora
citrophthora
(
See
Phytophthora
palmivora)
37.
2570
Pyrazon
38.
3132
Sodium
fluoride
39.
4092
Thidiazuron
FY2005
TRED
Candidates:
N
Name
1.
Burkholderia
cepacia
2.
Cyhexatin
3.
Ethephon
4.
Fluazifop­
p­
butyl
5.
Flumiclorac­
pentyl
6.
Imazethabenz
7.
Maleic
hydrazide
8.
Methyl
eugenol
9.
Nicosulfuron
10.
Sulfuric
acid
monourea
11.
Tanol
derivitives
FY2006
RED/
IRED
Candidates:
N
Case
Name
1.
0140
Aldicarb
(
as
an
IRED)
2.
3004
Aliphatic
solvents
3.
3020
Aromatic
solvents
4.
3021
Arsenal
(*)
(
Imazapyr)
5.
0101
Carbofuran
(
as
an
IRED)
6.
0040
Chloropicrin
7.
0649
Copper
compounds:
Grp
II
8.
0636
Copper
sulfate
9.
4025
Copper,
and
oxides
10.
2130
Cypermethrin
11.
0113
DCNA
12.
0065
Dicamba
13.
0161
Dodine
14.
2275
Ethylene
oxide
15.
2295
Fluvalinate
16.
0556
Formaldehyde
17.
4054
Inorg.
polysulfides
18.
4056
Inorg.
sulfites
Page
64
of
65
19.
2365
MCPB,
and
salts
20.
0576
Metaldehyde
21.
2430
MGK­
264
(*)
22.
3099
Naphthenate
salts
23.
2510
Permethrin
24.
2525
Piperonyl
butoxide
25.
3125
Propiconazole
26.
2560
Propylene
oxide
27.
2580
Pyrethrin,
and
derivs
28.
0421
Resmethrin
29.
0255
Rotenone
30.
4080
Salicylic
acid,
and
derivs
31.
2600
Sethoxydim
32.
0070
Simazine
(
as
an
IRED)
33.
2625
TCMB
34.
2700
Triadimefonre
FY2006
TRED
Candidates:
N
Name
1.
Acetochlor
2.
Ammonia
3.
Azadirachitin
4.
Benzaldehyde
5.
Bitertanol
6.
Bromine
7.
Ethalfluralin
8.
Fomesafen
9.
Imazaquin
10.
Menthol
11.
Oxytetracycline
12.
Procymidone
13.
Propazine
14.
Sodium
Cyanide
(
hydrocyanic
acid)
15.
Streptomycin
16.
Tetradifon
17.
Triadimenol
18.
Tridemorph
Import
Tolerance
Candidates:
There
are
three
known
pesticide
ingredients
which
have
no
active
U.
S.
registrations,
but
have
import
tolerances
and
are
subject
to
DCIs
as
needed.
EPA
has
published
guidance
on
how
to
adapt
data
requirements
for
U.
S.
food
uses
to
import
tolerances
(
65
FR
35069,
June
1,
2000)
(
FRL­
6559­
3).
Page
65
of
65
N
Name
1.
Cadusafos
2.
Mevinphos
3.
Phosalone
(*)
Indicates
use
of
trade
name
as
case
name
in
place
of
a
long
chemical
name
for
most
of
these.