Document ID: EPA-HQ-OPP-2002-0327-0001
Agency: epa
Document Type: Notice
Title: Pesticide Reregistration Performance Measures and Goals
Posted Date: 2003-07-30T04:00Z

44767
Federal
Register
/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
slides
for
distribution
to
the
participants
and
public
at
the
meeting.
Written
Comments:
Although
written
comments
are
accepted
until
the
date
of
the
meeting
(
unless
otherwise
stated),
written
comments
should
be
received
in
the
SAB
Staff
Office
at
least
one
week
prior
to
the
meeting
date
so
that
the
comments
may
be
made
available
to
the
committee
for
their
consideration.
Comments
should
be
supplied
to
the
DFO
at
the
address/
contact
information
noted
above
in
the
following
formats:
One
hard
copy
with
original
signature,
and
one
electronic
copy
via
e­
mail
(
acceptable
file
format:
Adobe
Acrobat,
WordPerfect,
Word,
or
Rich
Text
files
(
in
IBM­
PC/
Windows
95/
98
format).
Those
providing
written
comments
and
who
attend
the
meeting
are
also
asked
to
bring
35
copies
of
their
comments
for
public
distribution.
Meeting
Accommodations:
Individuals
requiring
special
accommodation
to
access
these
meetings,
should
contact
Dr.
Nugent
at
least
five
business
days
prior
to
the
meeting
so
that
appropriate
arrangements
can
be
made.

Dated:
July
22,
2003.
Vanessa
T.
Vu,
Director,
EPA
Science
Advisory
Board
Staff
Office.
[
FR
Doc.
03
 
19277
Filed
7
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0327;
FRL
 
7284
 
6]

Pesticide
Reregistration
Performance
Measures
and
Goals
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
EPA's
progress
in
meeting
its
performance
measures
and
goals
for
pesticide
reregistration
during
fiscal
year
2002.
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
requires
EPA
to
publish
information
about
EPA's
annual
achievements
in
this
area.
This
notice
discusses
the
integration
of
tolerance
reassessment
with
the
reregistration
process,
and
describes
the
status
of
various
regulatory
activities
associated
with
reregistration
and
tolerance
reassessment.
The
notice
gives
total
numbers
of
chemicals
and
products
reregistered,
tolerances
reassessed,
Data
Call­
Ins
issued,
and
products
registered
under
the
``
fasttrack
provisions
of
FIFRA.
Finally,
this
notice
contains
the
schedule
for
completion
of
activities
for
specific
chemicals
during
fiscal
years
2003
and
2004.
DATES:
This
notice
is
not
subject
to
a
formal
comment
period.
Nevertheless,
EPA
welcomes
input
from
stakeholders
and
the
general
public.
Written
comments,
identified
by
the
docket
ID
number
[
OPP
 
2002
 
0327],
should
be
received
on
or
before
September
29,
2003.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION
section
of
this
notice.
FOR
FURTHER
INFORMATION
CONTACT:
Carol
P.
Stangel,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
telephone:
(
703)
308
 
8007,
e­
mail:
stangel.
carol@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
Important
Information
A.
Does
this
Apply
to
Me?

This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
persons
who
are
interested
in
the
progress
and
status
of
EPA's
pesticide
reregistration
and
tolerance
reassessment
programs,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
information
in
this
notice,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information
or
Copies
of
Support
Documents?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2002
 
0327.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although,
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
To
access
information
about
pesticide
reregistration,
go
to
the
home
page
for
the
Office
of
Pesticide
Programs
at
www.
epa.
gov/
pesticides
and
select
``
Reregistration''
under
``
Regulating
Pesticides,''
or
go
directly
to
www.
epa.
gov/
pesticides/
reregistration/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although,
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
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44768
Federal
Register
/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment,
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
2.
EPA
Dockets
 
i.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2002
 
0327.
The
system
is
an,
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2002
 
0327.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency
(
7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2002
 
0327.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2002
 
0327.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
Background
EPA
must
establish
and
publish
in
the
Federal
Register
its
annual
performance
measures
and
goals
for
pesticide
reregistration,
tolerance
reassessment,
and
expedited
registration,
under
section
4(
l)
of
FIFRA,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
Specifically,
such
measures
and
goals
are
to
include:
 
The
status
of
reregistration.
 
The
number
of
products
reregistered,
canceled,
or
amended.
 
The
number
and
type
of
data
requests
or
Data
Call­
In
(
DCI)
notices
under
section
3(
c)(
2)(
B)
issued
to
support
product
reregistration
by
active
ingredient.
 
Progress
in
reducing
the
number
of
unreviewed,
required
reregistration
studies.
 
The
aggregate
status
of
tolerances
reassessed.
 
The
number
of
applications
for
registration
submitted
under
subsection
(
k)(
3),
expedited
processing
and
review
of
similar
applications,
that
were
approved
or
disapproved.
 
The
future
schedule
for
reregistrations
in
the
current
and
succeeding
fiscal
year.
 
The
projected
year
of
completion
of
the
reregistrations
under
section
4.
FIFRA,
as
amended
in
1988,
authorizes
EPA
to
conduct
a
comprehensive
pesticide
reregistration
program­­
a
complete
review
of
the
human
health
and
environmental
effects
of
older
pesticides
originally
registered
before
November
1,
1984.
Pesticides
meeting
today's
scientific
and
regulatory
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Federal
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/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
standards
may
be
declared
``
eligible''
for
reregistration.
To
be
eligible,
an
older
pesticide
must
have
a
substantially
complete
data
base,
and
must
not
cause
unreasonable
adverse
effects
to
human
health
or
the
environment
when
used
according
to
Agency
approved
label
directions
and
precautions.
In
addition,
all
pesticides
with
food
uses
must
meet
the
safety
standard
of
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
Under
FFDCA,
EPA
must
make
a
determination
that
pesticide
residues
remaining
in
or
on
food
are
``
safe'';
that
is,
``
that
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue''
from
dietary
and
other
sources.
In
determining
allowable
levels
of
pesticide
residues
in
food,
EPA
must
perform
a
more
comprehensive
assessment
of
each
pesticide's
risks,
considering:
 
Aggregate
exposure
(
from
food,
drinking
water,
and
residential
uses).
 
Cumulative
effects
from
all
pesticides
sharing
a
common
mechanism
of
toxicity.
 
Possible
increased
susceptibility
of
infants
and
children;
and
 
Possible
endocrine
or
estrogenic
effects.
As
amended
by
FQPA,
FFDCA
requires
the
reassessment
of
all
existing
tolerances
(
pesticide
residue
limits
in
food)
and
tolerance
exemptions
within
10
years,
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
9,721
existing
tolerances
and
exemptions
within
3
years
(
by
August
3,
1999),
66%
within
6
years
(
by
August
3,
2002),
and
100%
in
10
years
(
by
August
3,
2006).
(
Note:
Although
the
total
number
of
tolerances
existing
on
August
3,
1996,
and
subject
to
FQPA
reassessment
was
initially
reported
as
9,728,
that
number
has
been
corrected
to
9,721,
based
on
the
Agency's
Tolerance
Reassessment
Tracking
System.)
EPA
is
meeting
the
FFDCA's
tolerance
reassessment
requirements
through
reregistration
and
several
other
program
activities.
In
making
reregistration
eligibility
decisions,
the
Agency
also
is
completing
much
of
tolerance
reassessment,
which
is
helping
us
meet
the
time
frames
mandated
by
the
new
law.
EPA
reassessed
the
first
33%
of
all
food
tolerances
by
August
3,
1999,
and
the
second
33%
of
all
food
tolerances
by
August
3,
2002.
EPA
is
focusing
particularly
on
priority
Group
1
pesticides,
those
identified
as
posing
the
greatest
potential
risks.
Over
half
of
the
universe
of
tolerances
to
be
reassessed
are
included
in
this
category,
including
tolerances
for
the
organophosphate
(
OP)
pesticides,
the
Agency's
highest
priority
for
review.
Carbamate,
organochlorine,
and
B2
(
probable
human)
carcinogen
pesticides
also
are
included
in
priority
Group
1.
Although
EPA
is
directing
most
of
its
resources
toward
this
group,
a
number
of
Group
1
pesticides
will
nevertheless
be
reassessed
in
the
third
33%
owing
to
the
challenging
issues
they
present.
EPA's
approach
to
tolerance
reassessment
under
FFDCA,
including
the
three
priority
Groups,
is
described
fully
in
the
Agency's
document,
``
Raw
and
Processed
Food
Schedule
for
Pesticide
Tolerance
Reassessment''
(
62
FR
42020,
August
4,
1997)
(
FRL
 
5734
 
6).
In
conducting
the
pesticide
reregistration
and
tolerance
reassessment
programs
at
present,
EPA
is
developing
measures
that
show
results
in
terms
of
outcomes,
as
well
as
traditional
outputs,
as
directed
by
OMB.

III.
FQPA
and
Program
Accountability
One
of
the
hallmarks
of
the
FQPA
amendments
to
the
FFDCA
is
enhanced
accountability.
Through
this
summary
of
performance
measures
and
goals
for
pesticide
reregistration,
tolerance
reassessment,
and
expedited
registration,
EPA
describes
progress
made
during
the
past
year
in
each
of
the
program
areas
included
in
FIFRA
section
4(
l).

A.
Status
of
Reregistration
During
fiscal
year
(
FY)
2002
(
from
October
1,
2001,
through
September
30,
2002),
EPA
made
significant
progress
in
completing
risk
assessments
and
risk
management
decisions
for
the
OP
pesticides,
the
Agency's
highest
priority
chemicals
for
reregistration
and
tolerance
reassessment,
and
for
other
pesticides.
See
Table
1.

TABLE
1.
 
REREGISTRATION/
RISK
MANAGEMENT
DECISIONS
COMPLETED:
FY
2002
AND
TOTAL
FY
2002:
36
Decisions
Total,
End
of
FY
2002
7
REDs
1,4­
Bis(
bromoacetoxy)­
2­
butene
Endosulfan1
Fenamiphos
(
Voluntary
Cancellation)
2
(
HOCH2­)
methyldithiocarbamate
(
Voluntary
Cancellation)
Lindane1
Oxyfluorfen
Thiabendazole
214
REDs
8
IREDs
Azinphos­
methyl1,2
Diazinon1,2
Dicrotophos2
Disulfoton2
Methamidophos2
Naled2
Oxydemeton­
methyl2
Phosmet1,2
21
IREDs
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TABLE
1.
 
REREGISTRATION/
RISK
MANAGEMENT
DECISIONS
COMPLETED:
FY
2002
AND
TOTAL
 
Continued
FY
2002:
36
Decisions
Total,
End
of
FY
2002
21
TREDs
Asulam
Calcium
hypochlorite
Chlorine
gas
Chlorpropham
Difenzoquat
Diquat
dibromide
Diuron
(
RED
to
be
completed
in
FY
2003)
Fenarimol
Fenbutatin­
oxide
Hexazinone
Imazalil
(
RED
to
be
completed
in
FY
2003)
Linuron
Metolachlor
Norflurazon
Primisulfuron­
methyl
Pronamide
Propanil
(
RED
to
be
completed
in
FY
2003)
Sodium
hypochlorite
Tebuthiuron
Tetrachlorvinphos2
Urea
32
TREDs
1Subject
to
NRDC
consent
decree
2Organophosphate
(
OP)
pesticide
The
Agency's
decisions
are
embodied
in
Reregistration
Eligibility
Decision
(
RED)
documents,
Interim
Reregistration
Eligibility
Decisions
(
IREDs),
or
Reports
on
FQPA
Tolerance
Reassessment
Progress
and
Interim
Risk
Management
Decisions
(
TREDs).
1.
REDs.
Through
the
reregistration
program,
EPA
is
reviewing
current
scientific
data
for
older
pesticides
(
those
initially
registered
before
November
1984),
reassessing
their
effects
on
human
health
and
the
environment,
and
requiring
risk
mitigation
measures
as
necessary.
Pesticides
that
have
sufficient
supporting
data
and
whose
risks
can
be
successfully
mitigated
may
be
declared
``
eligible''
for
reregistration.
EPA
presents
these
pesticide
findings
in
a
RED
document.
i.
Overall
RED
progress.
EPA's
overall
progress
at
the
end
of
FY
2002
in
completing
Reregistration
Eligibility
Decisions
(
REDs)
is
summarized
in
Table
2.

TABLE
2.
 
OVERALL
RED
PROGRESS,
END
OF
FY
2002
REDs
completed
214
(
35%)

Cases
canceled
231
(
38%)

REDs
to
be
completed
167
(
27%)

Total
reregistration
cases
612
(
100%)

ii.
Profile
of
completed
REDs.
A
profile
of
the
214
REDs
completed
by
the
end
of
FY
2002
is
presented
in
Table
3.

TABLE
3.
 
PROFILE
OF
214
REDS
COMPLETED,
END
OF
FY
2002
Pesticide
active
ingredients
313
Pesticide
products
8,600+

REDs
with
food
uses
107
Post­
FQPA
REDs
73
Post­
FQPA
REDs
with
food
uses
54
Tolerance
reassessments
completed
for
post­
FQPA
REDs*
1,322
*
EPA
is
revisiting
tolerances
associated
with
the
53
food
use
REDs
that
were
completed
before
FQPA
was
enacted
to
ensure
that
they
meet
the
safety
standard
of
the
new
law,
as
set
forth
in
the
Agency's
August
4,
1997,
Schedule
for
Pesticide
Tolerance
Reassessment.

iii.
Risk
reduction
in
REDs.
Reducing
pesticide
risks
is
an
important
aspect
of
the
reregistration
program.
In
developing
REDs,
EPA
works
with
stakeholders
including
pesticide
registrants,
growers
and
other
pesticide
users,
and
environmental
and
public
health
interests,
as
well
as
the
States,
USDA,
and
other
Federal
agencies
and
others
to
develop
voluntary
measures
or
regulatory
controls
needed
to
effectively
reduce
risks
of
concern.
Almost
every
RED
includes
some
measures
or
modifications
to
reduce
risks.
The
options
for
such
risk
reduction
are
extensive
and
include
voluntary
cancellation
of
pesticide
products
or
deletion
of
uses;
declaring
certain
uses
ineligible
or
not
yet
eligible
(
and
then
proceeding
with
follow­
up
action
to
cancel
the
uses
or
require
additional
supporting
data);
restricting
use
of
products
to
certified
applicators;
limiting
the
amount
or
frequency
of
use;
improving
use
directions
and
precautions;
adding
more
protective
clothing
and
equipment
requirements;
requiring
special
packaging
or
engineering
controls;
requiring
notreatment
buffer
zones;
employing
ground
water,
surface
water,
or
other
environmental
and
ecological
safeguards;
and
other
measures.
2.
Interim
REDs
or
IREDs.
EPA
issues
IREDs
for
pesticides
that
are
undergoing
reregistration,
require
a
reregistration
eligibility
decision,
and
also
must
be
included
in
a
cumulative
assessment
under
FQPA
because
they
are
part
of
a
group
of
pesticides
that
share
a
common
mechanism
of
toxicity.
An
IRED
is
issued
for
each
individual
pesticide
in
the
cumulative
group
when
EPA
completes
the
pesticide's
risk
assessment
and
interim
risk
management
decision.
An
IRED
may
include
measures
to
reduce
food,
drinking
water,
residential,
occupational,
and/
or
ecological
risks,
to
gain
the
benefit
of
these
changes
before
the
final
RED
can
be
issued
following
the
Agency's
consideration
of
cumulative
risks.
For
example,
EPA
generally
does
not
consider
individual
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OP
or
N­
methyl
carbamate
pesticide
decisions
to
be
completed
REDs
or
tolerance
reassessments.
Instead,
the
Agency
is
issuing
IREDs
for
these
chemicals
at
this
time.
EPA
will
make
final
decisions
and
may
issue
REDs
for
these
pesticides
when
the
cumulative
risks
of
the
OPs
or
carbamates
have
been
considered.
Once
the
Agency
completes
a
cumulative
evaluation
of
the
OPs,
final
decisions
will
be
made
and
REDs
may
be
issued
for
the
24
OP
pesticides
that
initially
had
IREDs.
3.
Tolerance
reassessment
``
TREDs.''
EPA
issues
Reports
on
FFDCA
Tolerance
Reassessment
Progress
and
Interim
Risk
Management
Decisions,
known
as
TREDs,
for
pesticides
that
require
tolerance
reassessment
decisions
under
FFDCA,
but
do
not
require
a
reregistration
eligibility
decision
at
present
because:
 
The
pesticide
was
first
registered
after
November
1984
and
is
considered
a
``
new''
active
ingredient,
not
subject
to
reregistration
(
e.
g.,
fenarimol
and
primisulfuron­
methyl
in
FY
2002);
 
EPA
completed
a
RED
for
the
pesticide
before
FQPA
was
enacted
(
most
FY
2002
TREDs
are
in
this
post­
RED
category);
or
 
The
pesticide
is
not
registered
for
use
in
the
U.
S.
but
tolerances
are
established
that
allow
crops
treated
with
the
pesticide
to
be
imported
from
other
countries
(
e.
g.,
mevinphos).
During
FY
2002,
EPA
also
completed
TREDs
for
three
pesticides
(
diuron,
imazalil,
and
propanil)
whose
REDs
are
under
development.
The
Agency
expects
to
complete
REDs
for
these
pesticides
in
FY
2003.
As
with
IREDs,
EPA
will
not
take
final
action
on
pesticides
subject
to
TREDs
that
are
part
of
a
cumulative
group
until
cumulative
risks
have
been
considered
for
the
group.
4.
Goals
for
FY
2003
and
future
years.
EPA's
major
pesticide
reregistration
and
tolerance
reassessment
goals
for
FY
2003
and
future
years
are
as
follows.
In
addition
to
achieving
these
traditional
output­
oriented
goals,
EPA
also
is
working
to
develop
measures
that
show
results
in
terms
of
outcomes,
as
directed
by
OMB.
i.
Complete
individual
pesticide
risk
management
decisions.
EPA's
goal
in
conducting
the
reregistration
and
tolerance
reassessment
program
is
to
complete
20
 
35
Reregistration
Eligibility
Decisions
(
REDs)
and
Interim
REDs
each
year
during
fiscal
years
2003
through
2006,
giving
priority
to
pesticides
with
associated
tolerances.
Candidate
pesticides
for
these
decisions
are
listed
near
the
end
of
this
document.
ii.
Evaluate
OP
and
other
cumulative
risks.
EPA
began
developing
methods
for
cumulative
risk
assessment
and
the
components
of
a
cumulative
risk
assessment
for
the
OP
pesticides
soon
after
FQPA
was
enacted
in
August
1996,
although
the
Agency
had
begun
considering
this
approach
earlier,
when
it
was
recommended
by
NAS
in
their
1993
report,
``
Pesticides
in
the
Diets
of
Infants
and
Children.''
These
efforts
came
to
fruition
in
FY
2002.
In
addition
to
completing
most
of
the
remaining
risk
assessments
and
risk
management
decisions
for
individual
OP
pesticides,
EPA
issued
the
preliminary
OP
cumulative
risk
assessment
in
December
2001.
After
considering
public
comment,
stakeholder
input,
and
the
results
of
additional
scientific
review,
EPA
issued
a
revised
OP
cumulative
risk
assessment
in
June
2002
and
has
begun
risk
management
actions
based
on
this
revised
assessment.
The
Agency
plans
to
review
public
and
SAP
comments
on
the
revised
cumulative
risk
assessment
as
well
as
examine
newly
submitted
data
in
further
evaluating
OP
cumulative
risks
during
2003.
The
Agency
then
may
issue
final
reregistration
eligibility
and
tolerance
reassessment
decisions
for
individual
OP
pesticides
with
IREDs
and
TREDs.
Consideration
of
the
cumulative
risks
of
N­
methylcarbamates,
chloroacetanilides,
and
perhaps
other
common
mechanism
groups
of
pesticides
will
follow.
For
further
information,
see
EPA's
cumulative
risk
website,
http://
www.
epa.
gov/
pesticides/
cumulative/.
iii.
Complete
100%
of
tolerance
reassessment
decisions.
EPA
is
continuing
to
reassess
tolerances
within
time
frames
set
forth
in
FFDCA
as
amended
by
FQPA,
giving
priority
to
those
food
use
pesticides
that
appear
to
pose
the
greatest
risk.
Integration
of
the
reregistration
and
tolerance
reassessment
programs
has
added
complexity
to
the
reregistration
process
for
food
use
pesticides.
The
Agency
successfully
reached
its
first
two
tolerance
reassessment
milestones
by
completing
over
33%
of
all
tolerance
reassessment
decisions
by
August
3,
1999,
and
over
66%
by
August
3,
2002.
EPA
is
working
toward
meeting
the
final
FQPA
tolerance
reassessment
goal:
To
complete
100%
of
all
required
tolerance
reassessment
decisions
by
August
3,
2006.

B.
Product
Reregistration;
Numbers
of
Products
Reregistered,
Canceled,
and
Amended
At
the
end
of
the
reregistration
process,
after
EPA
has
issued
a
RED
and
declared
a
pesticide
reregistration
case
eligible
for
reregistration,
individual
end­
use
products
that
contain
pesticide
active
ingredients
included
in
the
case
still
must
be
reregistered.
This
concluding
part
of
the
reregistration
process
is
called
``
product
reregistration.''
In
issuing
a
completed
RED
document,
EPA
sends
registrants
a
Data
Call­
In
(
DCI)
notice
requesting
any
product­
specific
data
and
specific
revised
labeling
needed
to
make
final
reregistration
decisions
for
each
of
the
individual
pesticide
products
covered
by
the
RED.
Based
on
the
results
of
EPA's
review
of
these
data
and
labeling,
products
found
to
meet
FIFRA
and
FFDCA
standards
may
be
reregistered.
A
variety
of
outcomes
are
possible
for
pesticide
products
completing
this
final
phase
of
the
reregistration
process.
Ideally,
in
response
to
the
DCI
notice
accompanying
the
RED
document,
the
pesticide
producer,
or
registrant,
will
submit
the
required
product­
specific
data
and
revised
labeling,
which
EPA
will
review
and
find
acceptable.
At
that
point,
the
Agency
may
reregister
the
pesticide
product.
If,
however,
the
product
contains
multiple
active
ingredients,
the
Agency
instead
issues
an
amendment
to
the
product's
registration,
incorporating
the
labeling
changes
specified
in
the
RED;
a
product
with
multiple
active
ingredients
may
not
be
fully
reregistered
until
the
last
active
ingredient
in
its
formulation
is
eligible
for
reregistration.
In
other
situations,
the
Agency
may
temporarily
suspend
a
product's
registration
if
the
registrant
has
not
submitted
required
product­
specific
studies
within
the
time
frame
specified.
The
Agency
may
cancel
a
product's
registration
because
the
registrant
did
not
pay
the
required
registration
maintenance
fee.
Alternatively,
the
registrant
may
request
a
voluntary
cancellation
of
their
end­
use
product
registration.
1.
Product
reregistration
actions
in
FY
2002.
EPA
counts
each
of
the
post­
RED
product
outcomes
described
above
as
a
product
reregistration
action.
A
single
pesticide
product
may
be
the
subject
of
several
product
reregistration
actions
within
the
same
year.
For
example,
a
product's
registration
initially
may
be
amended,
then
the
product
may
be
reregistered,
and
later
the
product
may
be
voluntarily
canceled,
all
within
the
same
year.
During
FY
2002,
EPA
completed
the
product
reregistration
actions
detailed
in
Table
4.
The
program's
goal
is
to
complete
400
 
450
product
reregistration
actions
in
FY
2003.

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TABLE
4.
 
PRODUCT
REREGISTRATION
ACTIONS
COMPLETED
DURING
FY
2002
Product
reregistration
actions
77
Product
amendment
actions
51
Product
cancellation
actions
186
Total
actions
314
2.
Status
of
the
product
reregistration
universe.
The
status
of
the
universe
of
pesticide
products
subject
to
reregistration
at
the
end
of
FY
2002
is
shown
in
Table
5
below.
This
overall
status
information
is
not
``
cumulative''­
­
it
is
not
derived
from
summing
up
a
series
of
annual
actions.
Adding
annual
actions
would
result
in
a
larger
overall
number
since
each
individual
product
is
subject
to
multiple
actions­­
it
can
be
amended,
reregistered,
and/
or
canceled,
over
time.
Instead,
the
``
big
picture''
status
information
in
Table
5
should
be
considered
a
snapshot
in
time.
As
registrants
and
EPA
make
marketing
and
regulatory
decisions
in
the
future,
the
status
of
individual
products
may
change,
and
numbers
in
this
table
are
expected
to
fluctuate.
TABLE
5.
 
STATUS
OF
THE
UNIVERSE
OF
PRODUCTS
SUBJECT
TO
PRODUCT
REREGISTRATION,
FOR
FY
2002
(
AS
OF
SEPTEMBER
30,
2002)

Products
reregistered
1,637
Products
amended
345
Products
canceled
3,806
Products
sent
for
suspension
12
Total
products
with
actions
completed
5,800
Products
with
actions
pending
2,817
Total
products
in
product
reregistration
universe
8,617
The
universe
of
8,617
products
in
product
reregistration
at
the
end
of
FY
2002
represented
an
increase
of
745
products
from
the
FY
2001
universe
of
7,872
products.
The
increase
consists
of
324
products
associated
with
FY
2002
REDs,
and
412
products
associated
with
IREDs,
plus
9
products
that
were
added
as
a
result
of
DCI
activities
and
processing
for
several
previously
issued
REDs
and
IREDs.
At
the
end
of
FY
2002,
2,817
products
had
product
reregistration
decisions
pending.
Some
pending
products
await
science
reviews,
label
reviews,
or
reregistration
decisions
by
EPA.
Others
are
not
yet
ready
for
product
reregistration
actions;
they
are
associated
with
more
recently
completed
REDs,
and
their
productspecific
data
are
not
yet
due
to
be
submitted
to
or
reviewed
by
the
Agency.
EPA's
goal
is
to
complete
400
 
450
product
reregistration
actions
during
fiscal
year
2003.

C.
Number
and
Type
of
DCIs
to
Support
Product
Reregistration
by
Active
Ingredient
1.
DCIs
for
REDs.
The
number
and
type
of
data
call­
in
requests
or
DCIs
that
EPA
is
preparing
to
issue
under
FIFRA
section
3(
c)(
2)(
B)
to
support
product
reregistration
for
pesticide
active
ingredients
included
in
FY
2002
REDs
are
shown
in
Table
6.
Starting
in
FY
2001,
for
the
first
time,
OMB
clearance
has
been
required
to
issue
REDs
and
IREDs.
Since
the
Fenamiphos
and
(
HOCH2­)
methyldithiocarbamate
REDs
consisted
of
voluntary
cancellations,
products
containing
these
pesticides
will
not
be
reregistered
and
therefore
do
not
require
DCIs.

TABLE
6.
 
DCIS
PREPARED
TO
SUPPORT
PRODUCT
REREGISTRATION
FOR
FY
2002
REDS
Case
Number
Case
Name
Number
of
Products
Covered
by
the
RED1
Number
of
Product
Chemistry
Studies
Required2
Number
of
Acute
Toxicology
Studies
Required3
Number
of
Efficacy
Studies
Required
3030
1,4­
Bis(
bromoacetoxy)­
2­
butene
2
22
12
(
6
studies
x
2
products)
­­

0014
Endosulfan
98
(
includes
4
SLN
products)
22
102
(
7
batches/
10
not
batched)
0
0333
Fenamiphos
(
Voluntary
Cancellation)
15
N/
A
N/
A
N/
A
3076
(
HOCH2­)
methyldithiocarbamate
(
Voluntary
Cancellation
0
N/
A
N/
A
N/
A
0315
Lindane
29
22
126
(
5
batches/
16
not
batched)
0
2490
Oxyfluorfen
117
(
includes
8
SLN
products)
22
60
(
4
batches/
6
not
batched)
0
2670
Thiabendazole
63
22
144
(
4
batches/
20
not
batched)
0
1The
number
of
registered
products
containing
a
pesticide
active
ingredient
can
change
over
time.
The
number
of
products
that
appears
in
the
RED
document
(
counted
when
the
RED
is
signed)
may
be
different
than
the
number
of
products
that
EPA
is
tracking
for
product
reregistration
(
counted
later,
when
the
RED
is
issued).
This
table
reflects
the
final
number
of
products
associated
with
each
RED,
as
they
are
being
tracked
for
product
reregistration.
2This
column
shows
the
number
of
product
chemistry
studies
that
are
required
for
each
product
covered
by
the
RED.

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3In
an
effort
to
reduce
the
time,
resources,
and
number
of
animals
needed
to
fulfill
acute
toxicity
data
requirements,
EPA
``
batches''
products
that
can
be
considered
similar
from
an
acute
toxicity
standpoint.
For
example,
one
batch
could
contain
five
products.
In
this
instance,
if
six
acute
toxicology
studies
usually
were
required
per
product,
only
six
studies
(
rather
than
30
studies)
would
be
required
for
the
entire
batch.
Factors
considered
in
the
sorting
process
include
each
product's
active
and
inert
ingredients
(
e.
g.,
identity,
percent
composition,
and
biological
activity),
type
of
formulation
(
e.
g.,
emulsifiable
concentrate,
aerosol,
wettable
powder,
granular),
and
labeling
(
e.
g.,
signal
word,
use
classification,
precautionary
labeling).
The
Agency
does
not
describe
batched
products
as
``
substantially
similar,''
because
all
products
within
a
batch
may
not
be
considered
chemically
similar
or
have
identical
use
patterns.

2.
DCIs
for
IREDs.
The
number
and
type
of
data
requests
or
DCIs
that
EPA
is
preparing
to
issue
to
support
product
reregistration
for
pesticide
active
ingredients
included
in
FY
2002
Interim
REDs
(
IREDs)
are
shown
in
Table
7.

TABLE
7.
 
DCIS
PREPARED
TO
SUPPORT
PRODUCT
REREGISTRATION
FOR
FY
2002
IREDS
Case
Number
Case
Name
Number
of
Products
Covered
by
the
IRED
Number
of
Product
Chemistry
Studies
Required
Number
of
Acute
Toxicology
Studies
Required
Number
of
Efficacy
Studies
Required
0235
Azinphos­
methyl
24
22
54
(
4
batches/
5
not
batched)
0
0238
Diazinon
182
22
186
(
15
batches/
16
not
batched)
0
0145
Dicrotophos
3
22
6
(
1
batch)
­­

0102
Disulfoton
62
22
114
(
4
batches/
15
not
batched)
0
0043
Methamidophos
47
22
24
(
1
batch/
3
not
batched)
0
0092
Naled
35
22
78
(
2
batches/
11
not
batched)
2
0258
Oxydemeton­
methyl
19
(
includes
2
SLN
products)
22
12
(
2
batches)
0
0242
Phosmet
40
22
42
(
6
batches/
1
not
batched)
2
Note:
FIFRA
section
24(
c)
or
Special
Local
Need
(
SLN)
registrations
are
not
included
in
acute
toxicity
batchings
because
they
are
supported
by
a
valid
parent
product
(
section
3)
registration.

3.
DCIs
not
needed
for
TREDs.
The
Agency
does
not
issue
product­
specific
data
requests
or
DCIs
for
pesticides
included
in
tolerance
reassessment
decisions
or
TREDs
because,
at
present,
these
pesticides
do
not
require
product
reregistration
decisions;
they
are
subject
to
tolerance
reassessment
only.
D.
Progress
in
Reducing
the
Number
of
Unreviewed,
Required
Reregistration
Studies
EPA
is
making
progress
in
reviewing
scientific
studies
submitted
by
pesticide
registrants
in
support
of
pesticides
undergoing
reregistration.
See
Table
8.

TABLE
8.
 
REVIEW
STATUS
OF
STUDIES
SUBMITTED
FOR
PESTICIDE
REREGISTRATION,
END
OF
FY
2002
Pesticide
Reregistration
Group
or
List,
per
FIFRA
Section
4(
c)(
2)
Studies
Reviewed
+
Extraneous1
Studies
Awaiting
Review
Total
Studies
Received
List
A
11,237
+
470
=
11,707
(
84%)
2,201
(
16%)
13,908
List
B
6,453
+
746
=
7,199
(
75%)
2,408
(
25%)
9,607
List
C
2,271
+
239
=
2,510
(
73%)
938
(
27%)
3,448
List
D
1,342
+
94
=
1,436
(
82%)
308
(
18%)
1,744
Total
Lists
A
­
D
21,303
+
1,549
=
22,852
(
80%)
5,855
(
20%)
28,707
1Extraneous
studies
is
a
term
used
to
classify
those
studies
that
are
not
needed
because
the
guideline
or
data
requirement
has
been
satisfied
by
other
studies
or
has
changed.

Studies
reviewed
by
EPA
increased
(
or
the
study
review
``
backlog''
decreased)
during
FY
2002.
At
the
end
of
the
fiscal
year,
over
80%
of
all
studies
received
by
the
Agency
in
support
of
reregistration
had
been
reviewed,
compared
to
79%
at
the
end
of
FY
2001.
During
FY
2002,
the
Agency
continued
an
effort
to
clean
up
the
data
base
used
to
track
the
review
status
of
studies
submitted
for
reregistration.
The
percent
of
studies
reviewed
should
continue
to
increase
in
future
years.

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E.
Aggregate
Status
of
Tolerances
Reassessed
During
FY
2002,
EPA
completed
2,649
tolerance
reassessments
and
ended
the
fiscal
year
with
a
total
of
6,499
tolerance
reassessment
decisions
to
date,
addressing
almost
67%
of
the
9,721
tolerances
that
require
reassessment
(
See
Table
9).
Over
60%
of
the
tolerance
reassessment
decisions
completed
were
for
pesticides
in
priority
Group
1.
Just
as
EPA
reassessed
over
33%
of
all
food
tolerances
by
August
3,
1999,
including
many
tolerances
for
pesticides
identified
as
posing
the
greatest
potential
risks,
the
Agency
also
met
the
next
FQPA
goal
during
FY
2002
and
completed
over
66%
of
all
required
tolerance
reassessment
decisions
by
August
3,
2002.
EPA's
general
schedule
for
tolerance
reassessment
(
Federal
Register,
August
4,
1997)
identified
three
groups
of
pesticides
to
be
reviewed;
this
grouping
continues
to
reflect
the
Agency's
overall
scheduling
priorities.
In
completing
tolerance
reassessment,
EPA
continues
to
give
priority
to
pesticides
in
Group
1.
1.
Aggregate
accomplishments
through
reregistration
and
other
programs.
EPA
is
accomplishing
tolerance
reassessment
through
the
registration
and
reregistration
programs;
by
revoking
tolerances
for
pesticides
that
have
been
canceled
(
many
as
a
result
of
reregistration);
by
reevaluating
pesticides
with
pre­
FQPA
REDs,
and
through
other
decisions
not
directly
related
to
registration
or
reregistration,
described
further
below.
EPA
is
using
the
Tolerance
Reassessment
Tracking
System
(
TORTS)
to
compile
this
updated
information
and
report
on
the
status
of
tolerance
reassessment
(
See
Table
9).

TABLE
9.
 
TOLERANCE
REASSESSMENTS
COMPLETED
POST­
FQPA
BY
FISCAL
YEAR,
THROUGH
FY
2002
Tolerances
Reassessed
Through...
During
Late
FY
96
During
FY
1997
During
FY
1998
During
FY
1999
During
FY
2000
During
FY
2001
During
FY
2002
Total,
End
of
FY
2002
Reregistration/
REDs
25
339
278
359
44
46
231
1,322
Tolerance
Reassessments
TREDs
­­
­­
­­
­­
­­
­­
776
776
Registration
0
221
308
341
55
215
200
1,340
Tolerance
revocations
3
0
812
513
22
35
545
1,930
Other
decisions
0
1
0
233
0
0
897
1,131
Total
tolerances
reassessed
28
561
1,398
1,446
121
296
2,649
6,499
i.
Reregistration/
REDs.
EPA
is
using
the
reregistration
program
to
accomplish
much
of
tolerance
reassessment.
For
each
of
the
tolerance
reassessment
decisions
made
through
REDs
since
FQPA,
the
Agency
has
made
the
finding
as
to
whether
there
is
a
reasonable
certainty
of
no
harm,
as
required
by
FFDCA.
Many
tolerances
reassessed
through
reregistration
remain
the
same
while
others
may
be
raised,
lowered,
or
revoked.
ii.
Tolerance
reassessments/
TREDs.
Tolerances
initially
evaluated
through
REDs
that
were
completed
before
FQPA
was
enacted
in
August
1996
now
are
being
reassessed
to
ensure
that
they
meet
the
new
FFDCA
safety
standard.
EPA
issues
these
post­
RED
tolerance
reassessment
decisions
as
TREDs.
The
Agency
also
issues
TREDs
summarizing
tolerance
reassessment
decisions
for
some
developing
REDs,
for
new
pesticide
active
ingredients
not
subject
to
reregistration,
and
for
pesticides
with
import
tolerances
only.
Tolerance
reassessments
in
TREDs
for
pesticides
that
are
not
part
of
a
cumulative
group
(
i.
e.,
pesticides
that
are
not
OPs
or
carbamates)
may
be
counted
at
present
and
are
included
in
the
FY
2002
accomplishments.
In
completing
OP
IREDs
and
TREDs
during
FY
2002,
the
Agency
also
completed
tolerance
reassessment
decisions
for
these
pesticides.
Many
of
these
tolerance
reassessments
will
not
become
final,
however,
until
EPA
completes
a
cumulative
evaluation
of
the
OPs.
iii.
Registration.
Like
older
pesticides,
all
new
pesticide
registrations
must
meet
the
safety
standard
of
FFDCA.
Many
of
the
registration
applications
EPA
receives
are
for
new
uses
of
pesticides
already
registered
for
other
uses.
To
reach
a
decision
on
a
proposed
new
food
use
of
an
already
registered
pesticide,
EPA
must
reassess
the
existing
tolerances,
as
well
as
the
proposed
new
tolerances,
to
make
sure
there
is
reasonable
certainty
that
no
harm
will
result
to
the
public
from
aggregate
exposure
from
all
uses.
During
FY
2002,
the
Agency
has
continued
to
discourage
submission
of
applications
and
petitions
for
any
new
uses
of
the
OP
pesticides,
given
the
need
to
consider
cumulative
risks
from
OP's
as
a
group
before
any
new
uses
can
be
fully
evaluated.
iv.
Tolerance
revocations.
Revoked
tolerances
represent
uses
of
many
different
pesticide
active
ingredients
that
have
been
canceled
in
the
past.
Some
pesticides
were
canceled
due
to
the
Agency's
risk
concerns.
Others
were
canceled
voluntarily
by
their
manufacturers,
based
on
lack
of
support
for
reregistration.
Tolerance
revocations
are
important
even
if
there
are
no
domestic
uses
of
a
pesticide
because
residues
in
or
on
imported
commodities
treated
with
the
chemical
could
still
present
dietary
risks
that
may
exceed
the
FFDCA
``
reasonable
certainty
of
no
harm''
standard,
either
individually
or
cumulatively
with
other
substances
that
share
a
common
mechanism
of
toxicity.
v.
Other
reassessment
decisions.
In
addition
to
the
types
of
reassessment
actions
described
above,
a
total
of
1,131
additional
tolerance
reassessment
decisions
have
been
made,
not
directly
related
to
registration
or
reregistration.
A
list
of
these
other
tolerance
reassessment
decisions
with
their
Federal
Register
citations
is
available
in
the
docket
for
this
Federal
Register
notice.
2.
Accomplishments
for
priority
pesticides.
During
FY
2002,
EPA
completed
tolerance
reassessment
decisions
for
many
high
priority
pesticides
in
review,
including
OPs,
carbamates,
organochlorines,
and
carcinogens.
(
See
Table
10.)

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TABLE
10.
 
TOLERANCE
REASSESSMENTS
COMPLETED
FOR
PRIORITY
PESTICIDES
Pesticide
Class
Tolerances
to
be
Reassessed
Reassessed
by
End
of
FY
2002
Organophosphates
1,691
1,127
(
66.65%)

Carbamates
545
303
(
55.6%)

Organochlorines
253
253
(
100%)

Carcinogens
2,008
1,278
(
63.65%)

High
hazard
inerts
5
3
(
60%)

Other
5,219
­­

Total
9,721
6,499
(
66.86%)

3.
Tolerance
reassessment
and
the
organophosphates.
EPA
has
developed
an
approach
for
assessing
cumulative
risk
for
the
OPs
as
a
group,
as
required
by
FFDCA,
and
applied
this
methodology
in
conducting
the
OP
cumulative
risk
assessment
during
FY
2002.
The
Agency
presented
a
comprehensive
guidance
document
on
cumulative
risk
assessment
to
the
Scientific
Advisory
Panel
in
December
1999,
issued
draft
guidance
in
2000
for
review
and
comment,
and
presented
a
case
study
on
cumulative
risk
assessment
to
the
SAP
in
December
2000.
In
2001,
EPA
refined
the
methodology
and
began
developing
components
of
the
OP
cumulative
preliminary
risk
assessment.
With
input
from
the
Committee
to
Advise
on
Reassessment
and
Transition
(
CARAT)
workgroup,
the
Agency
developed
a
process
to
inform
stakeholders
and
encourage
their
participation
during
the
assessment
of
OP
cumulative
risks.
At
CARAT's
recommendation,
EPA
held
a
series
of
technical
briefings
to
explain
and
answer
questions
about
the
Agency's
methods
for
assessing
OP
cumulative
hazard,
as
well
as
exposure
through
drinking
water,
food,
and
in
residential
settings.
An
EPA
website
was
established
to
share
updated
information
on
pesticide
cumulative
risk
assessment
with
the
public
(
http:/
/
www.
epa.
gov/
pesticides/
cumulative).
In
FY
2002,
the
Agency
issued
a
preliminary
OP
cumulative
risk
assessment
on
December
3,
2001,
and
issued
a
revised
OP
cumulative
risk
assessment
on
June
10,
2002,
both
for
public
comment.
Through
this
assessment
of
the
OP
pesticides,
EPA
has
evaluated
1,127
OP
tolerances
and
found
that
most
require
no
modification
to
meet
the
new
FFDCA
safety
standard.
The
Agency's
regulatory
actions
on
individual
OP
pesticides
during
the
past
few
years
have
substantially
reduced
the
risks
of
these
pesticides.
The
OP
cumulative
assessment
strongly
supports
the
Agency's
confidence
that
the
U.
S.
has
one
of
the
safest
food
supplies
in
the
world.
Most
of
the
reregistration
and
tolerance
reassessment
decisions
that
EPA
is
making
for
the
OP
pesticides
at
present
will
not
be
considered
final
until
after
the
Agency
completes
its
cumulative
evaluation
of
the
OPs.
The
results
of
individual
OP
assessments
(
IRED
and
TRED
documents)
include
significant
risk
mitigation
measures,
however,
and
any
resulting
tolerance
revocations
are
counted
as
completed
tolerance
reassessments.
In
addition,
some
OP
tolerances
make
at
most
a
minimal
or
negligible
contribution
to
the
cumulative
risk
from
OP
pesticides;
these
tolerances
also
were
counted
as
reassessed
during
FY
2002.
Once
EPA
completes
a
cumulative
evaluation
of
the
OPs,
the
Agency
will
reconsider
individual
OP
IREDs
and
TREDs,
and
may
issue
final
REDs
and
tolerance
reassessments
for
these
pesticides.
4.
Status
of
individual
OP
decisions.
The
status
of
each
of
the
49
known
OP
pesticides
at
the
end
of
FY
2002
is
reflected
in
this
discussion.
i.
OP
decisions
completed.
During
FY
2002,
through
the
public
participation
process,
EPA
completed
risk
assessments
and
made
individual
risk
management
decisions
for
10
OP
pesticides,
bringing
the
number
of
OPs
with
individual
decisions
completed
to
35
(
See
List
1).
List
1.
 
OP
Pesticides
with
Individual
Decisions
Completed
(
35),
End
of
FY
2002
20
IREDs
Acephate
Azinphos­
methyl
Bensulide
Chlorpyrifos
Diazinon
Dicrotophos
Disulfoton
Ethoprop
Fenthion
Methamidophos
Methidathion
Naled
Oxydemeton­
methyl
Phorate
Phosmet
Pirimiphos
methyl
Profenofos
Propetamphos
Terbufos
Tribufos
(
DEF)
10
TREDs
Cadusafos
Chlorethoxyfos
Chlorpyrifos
methyl
Coumaphos
Fenitrothion
Mevinphos
Phosalone
Phostebupirim
Tetrachlorvinphos
Trichlorfon
5
REDs
Ethion
Ethyl
parathion
Fenamiphos
Sulfotepp
Temephos
ii.
OP
decisions
pending.
Four
other
OP
pesticides
had
completed
most
or
all
earlier
phases
of
the
public
participation
process
and
were
awaiting
individual
decisions
at
the
end
of
FY
2002.
EPA
plans
to
complete
individual
risk
management
decisions
for
these
4
pesticides
during
FY
2003
(
See
List
2).
List
2.
 
OP
Pesticides
with
Individual
Decisions
Pending
(
4),
End
of
FY
2002
Dichlorvos
(
DDVP)
Dimethoate
Malathion
Methyl
parathion
iii.
Early
OP
cancellations.
Ten
OP
pesticides
were
canceled
prior
to
or
early
in
the
pilot
public
participation
process
(
See
List
3).
List
3.
 
OPs
Canceled
Prior
to/
Early
in
the
Pilot
Public
Participation
Process
(
10)
Chlorfenvinphos
Chlorthiophos
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Notices
Dialifor
Dioxathion
Fonofos
Isazophos
Isofenphos
Monocrotophos
Phosphamidon
Sulprofos
F.
Applications
for
Registration
Requiring
Expedited
Processing;
Numbers
Approved
and
Disapproved
By
law,
EPA
must
expedite
its
processing
of
certain
types
of
applications
for
pesticide
product
registration,
i.
e.,
applications
for
end
use
products
that
would
be
identical
or
substantially
similar
to
a
currently
registered
product;
amendments
to
current
product
registrations
that
do
not
require
review
of
scientific
data;
and
products
for
public
health
pesticide
uses.
During
FY
2002,
EPA
considered
and
approved
the
numbers
of
applications
for
registration
requiring
expedited
processing
(
also
known
as
``
fast
track''
applications)
shown
in
Table
11.

TABLE
11.
 
FAST
TRACK
APPLICATIONS
APPROVED
IN
FY
2002
Me­
too
product
registrations
Fast
track
368
Amendments/
Fast
track
3,466
Total
applications
processed
by
expedited
means
3,834
Regarding
numbers
of
applications
disapproved,
instead
the
Agency
generally
notifies
the
registrant
of
any
deficiencies
in
the
application
that
need
to
be
corrected
or
addressed
before
the
application
can
be
approved.
Applications
may
have
been
withdrawn
after
discussions
with
the
Agency,
but
none
were
formally
``
disapproved''
during
FY
2002.
On
a
financial
accounting
basis,
EPA
devoted
approximately
28.7
full­
time
equivalents
(
FTEs)
in
FY
2002
to
reviewing
and
processing
applications
for
fast
track
me­
too
product
registrations
and
label
amendments.
The
Agency
spent
approximately
$
2.87
million
in
FY
2002
in
direct
costs
(
i.
e.,
time
on
task,
not
including
administrative
expenses,
computer
systems,
management
overhead,
and
other
indirect
costs)
on
expedited
processing
and
reviews.

G.
Future
Schedule
for
Reregistrations
During
the
past
several
years,
EPA
has
been
conducting
reregistration
in
conjunction
with
tolerance
reassessment
under
FFDCA.
That
law
requires
the
Agency
to
reassess
all
existing
tolerances
over
a
10
 
year
period
to
ensure
consistency
with
the
new
safety
standard,
and
to
consider
pesticides
that
appear
to
pose
the
greatest
risk
first.
In
prioritizing
pesticides
for
reregistration
eligibility
review
and
tolerance
reassessment,
EPA
is
continuing
to
consider
their
potential
risks,
as
reflected
in
the
Agency's
tolerance
reassessment
schedule
published
in
the
Federal
Register
on
August
4,
1997.
EPA
is
giving
highest
priority
to
pesticides
in
Group
1,
including
the
OP
pesticides,
and
the
carbamates,
organochlorines,
and
B2
(
probable
human)
carcinogens.
1.
RED,
IRED,
and
TRED
Candidate
Pesticides
for
FY
2003.
List
4
contains
candidate
pesticides
for
Reregistration
Eligibility
Decisions
(
REDs),
Interim
REDs
(
IREDs),
and
Reports
on
FQPA
Tolerance
Reassessment
Progress
and
Interim
Risk
Management
Decisions
(
TREDs)
in
FY
2003.
As
in
previous
years,
any
pesticides
for
which
decisions
are
not
completed
during
FY
2003
will
automatically
become
candidates
for
decisions
in
FY
2004.
List
4.
 
FY
2003
RED,
IRED,
and
TRED
Candidate
Pesticides
REDs
Chlorsulfuron
Chromated
copper
arsenate
(
CCA)
Coal
tar/
Creosote
Dihalodialkylhydantoins
Dinocap
Diuron
Ethoxyquin
Imazalil
MGK­
326
Molinate
Oxadiazon
Pentachlorophenol
Poly(
hexamethylenebiguanide)
(
PHMB)
Propanil
Thiophanate­
methyl
(
completed
3
 
28
 
03)
Zinc
omadine
Ziram
IREDs
Atrazine
(
completed
1
 
31
 
03)
Carbaryl
(
due
6
 
30
 
03)
Dichlorvos
(
DDVP)
Dimethoate
Malathion
Methyl
parathion
TREDs
4­
CPA
(
completed
4
 
3
 
03)
Dacthal
(
DCPA)
Ethephon
Fenridazon
potassium
Potassium
bromide
2.
RED,
IRED,
and
TRED
Candidate
Pesticides
for
FY
2004.
The
pesticides
that
are
in
the
pipeline
for
RED,
IRED,
and
TRED
decisions
in
FY
2004
are
included
in
List
5.
List
5.
 
FY
2004
RED,
IRED,
and
TRED
Candidate
Pesticides
REDs
2,4­
D
2,4­
DB
Azadioxabicyclo­
octane
Benfluralin
Benzisothiazolin­
3­
one
(
BIT)
Bioban
P­
1487
Busan
77
Cacodylic
acid/
DSMA/
MSMA
Carboxin
Cycloate
Cypermethrin
Fenvalerate
Formaldehyde
Mancozeb
Maneb
MCPA
Metiram
PCNB
Sodium
acifluorfen
Sodium
fluoride
Thiram
Trichloromelamine
Triethylene
glycol
IREDs
Aldicarb
Atrazine
revised
IRED
(
due
10
 
31
 
03)
Carbofuran
Formetanate
HCl
TREDs
Amitraz
Ethylene
glycol
monobutyl
ether
Fluazifop
butyl
Lactofen
Oryzalin
Sodium
xylenesulfonate
Sulfonated
oleic
acid,
sodium
salt
Trifluralin
H.
Projected
Year
of
Completion
of
Reregistrations
EPA
is
now
conducting
reregistration
in
conjunction
with
tolerance
reassessment,
which
FFDCA
mandates
be
completed
by
August
2006.
EPA
plans
to
complete
reregistration
of
pesticide
active
ingredients
with
tolerances
and
as
many
others
as
possible
in
meeting
the
statutory
deadline
for
completing
tolerance
reassessment.

List
of
Subjects
Environmental
protection,
Pesticides
and
pests.

Dated:
July
11,
2003.
Stephen
L.
Johnson,
Assistant
Administrator,
Office
of
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
03
 
19353
Filed
7
 
29
 
03;
8:
45
am]

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