Document ID: EPA-HQ-OPP-2004-0404-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-08-05T04:00Z

7/
28/
05
Explanation
of
Draft
Schedule
for
Pesticide
Registration
Review
I.
Purpose
This
document
explains
the
EPA's
draft
schedule
for
the
registration
review
program,
which
will
ensure
the
periodic
review
of
all
pesticides.
It
also
describes
EPA's
proposal
for
specific
chemical
class
groupings
within
the
overall
chronological
(
oldest
first)
schedule.

II.
Background
A.
Overview.
EPA
published
its
proposed
rule
[
http://
www.
epa.
gov/
fedrgstr/
EPAPEST
2005/
July/
Day­
13/
p13776.
htm]
for
the
registration
review
program
in
the
Federal
Register
on
July
13,
2005
with
a
90­
day
comment
period.
Information
on
the
proposed
rule
is
provided
at
http://
www.
epa.
gov/
oppsrrd1/
registration_
review/
index.
htm.

This
document
provides
background
on
the
draft
schedule
[
http://
www.
epa.
gov/
oppsrrd1/
registration_
review/
draft_
schedule.
htm]
for
the
registration
review
program.
This
draft
schedule
shows
which
chemical
cases
are
expected
to
begin
the
review
process
during
the
first
four
years
of
the
program.
Although
the
proposed
rule
states
that
EPA
will
provide
a
three­
year
schedule
with
annual
updates,
this
draft
schedule
includes
an
additional
year,
so
that
there
is
a
predictable
and
reliable
four­
year
planning
horizon.

B.
Program
Goal,
Registration
Review
Case,
Baseline
Dates,
and
Scheduling.
The
goal
of
the
registration
review
program
is
the
review
of
the
registrations
of
all
pesticides
every
fifteen
years
to
determine
whether
they
still
meet
the
standard
for
registration.
Under
the
proposed
rule,
EPA
would
establish
and
modify
registration
review
cases.
A
case
consists
of
one
or
more
active
ingredients
that
are
so
closely
related
in
chemical
structure
and
toxicological
profile
as
to
allow
common
use
of
some
or
all
of
the
required
data
for
hazard
assessments.
The
proposed
rule
also
states
that
EPA
will
establish
a
baseline
date
for
each
case.
 
The
baseline
date
for
pesticides
subject
to
reregistration
is
generally
the
date
of
the
Reregistration
Eligibility
Decision
(
RED)
or
the
Interim
Reregistration
Eligibility
Decision
(
IRED).
 
For
pesticides
not
subject
to
reregistration
(
i.
e.
those
active
ingredients
first
used
in
products
registered
on
November
1,
1984
or
later),
the
baseline
date
is
the
date
a
product
containing
one
of
the
active
ingredients
in
the
case
was
first
registered.
 
Cases
without
baseline
dates
currently
assigned
are
those
subject
to
reregistration
that
have
not
yet
had
a
RED
or
IRED
decision.

Under
the
proposed
rule,
EPA
would
develop
schedules
generally
based
on
baseline
dates,
but
EPA
may
change
the
placement
of
cases
in
the
schedule
where
warranted
to
achieve
program
efficiencies.
The
proposed
rule
states
that
OPP
will
post
schedules
on
the
Web
with
a
three­
year
projection
of
cases.
2
C.
Overview
of
Draft
Schedule.
The
draft
schedule
shows
which
cases
are
expected
to
have
dockets
opened
in
the
first
four
years
of
the
program
to
begin
the
registration
review
process.
It
lists
all
registration
review
cases
as
of
September
30,
2004.
Cases
for
pesticides
registered
after
that
date
will
be
included
on
subsequent
schedules.
The
number
of
registration
review
cases
is
currently
666,
comprising
1,056
active
ingredients.
 
Conventional
pesticides
have
441
cases
and
605
active
ingredients;
 
Antimicrobial
pesticides
have
115
cases
and
211
active
ingredients;
 
Biochemical
pesticides
have
69
cases
and
156
active
ingredients;
and
 
Microbial
pesticides
have
41
cases
and
84
active
ingredients.

EPA
will
need
to
open
44
or
more
cases
per
year
in
order
to
meet
the
goal
of
reviewing
all
pesticides
within
15
years.
It
will
generally
not
be
possible
to
have
final
decisions
in
the
same
year
that
dockets
are
opened
for
cases,
due
to
time
needed
to
complete
the
standard
registration
review
process:
open
the
docket;
receive
and
consider
comments;
issue
data
call­
ins,
when
needed;
await
study
submissions;
draft
preliminary
risk
assessments
and
receive
comment
on
them;
and
draft
and
issue
final
decisions.
For
the
first
several
years
of
the
program,
EPA
will
be
developing
a
pipeline
so
that
it
will
have
the
capacity
to
make
44
or
more
decisions
each
year.

D.
Start
Date
for
Registration
Review.
The
Agency
plans
to
begin
the
registration
review
program
in
fiscal
year
2007.
However,
resource
uncertainties
and
the
need
to
complete
reregistration
work,
including
RED
decisions
through
2008,
product
reregistration,
and
RED
implementation
follow
up,
may
affect
the
pace
of
the
review
process.

E.
Chronological
Schedule
Considering
Chemical
Classes
and
Groups.
Under
the
proposed
rule,
the
schedule
is
generally
determined
by
the
chronological
order
of
baseline
dates
for
each
case;
the
oldest
cases
generally
go
first.
Within
this
framework,
EPA
is
considering
reviewing
related
cases
at
the
same
time.
Cases
may
be
related
by
chemical
structure
or
for
other
reasons.
The
chemical
classes
and
groups
under
consideration
are
listed
in
Section
III.
G
of
this
document.
EPA
has
experienced
major
program
efficiencies
in
the
reregistration
program
when
it
has
considered
groups
of
cases
that
are
chemically
or
use
related,
such
as
the
organophosphates,
rodenticides,
and
soil
fumigants.
These
groupings
have
facilitated
the
resolution
of
technical
and
regulatory
issues
of
pesticides
with
commonalities.
There
are
also
efficiencies
from
grouping
in
collaborating
with
registrants
and
other
stakeholders
for
a
related
group
of
pesticides
to
address
issues
of
mutual
concern
and
interest.
The
grouping
approach
has
helped
maximize
resource
utilization
across
EPA
programs
and
in
working
with
other
federal
agencies.
Other
programs
in
EPA
use
a
similar
approach.

Pesticides
in
the
same
chemical
class
generally
have
similar
toxicity
profiles,
fate
properties
(
e.
g.,
persistence
and
leaching),
and
use
patterns.
They
also
have
comparable
labeling
requirements
and
are
studied
together
in
many
open
literature
articles.
Considering
members
of
a
class
together
will
facilitate
consideration
of
any
new
research
findings
about
new
common
mechanisms
of
toxicity
and
completion
of
any
resulting
cumulative
risk
assessments.
Considering
members
of
chemical
classes
and
groups
in
similar
time
frames
will
level
the
playing
field
among
cases
in
the
class;
3
ensure
that
data
call
ins,
when
needed,
will
be
issued
around
the
same
time;
and
permit
any
needed
risk
mitigation
to
occur
in
similar
time
frames.
Grouping
by
these
classes
should
also
save
resources
for
registrants
and
other
stakeholders.
For
example,
data
generation
and
assessment
costs
will
often
be
less
and
the
outcomes
more
refined
if
registrants
pool
resources.

The
chemical
groups
(
currently
rodenticides
and
soil
fumigants)
share
similar
characteristics
as
well,
including
similar
major
use
and
exposure
patterns
and
similar
toxicity
profiles
for
many
cases
in
the
group.
For
these
reasons,
OPP
has
already
undertaken
simultaneous
review
of
pesticides
within
the
rodenticide
and
soil
fumigant
groups
during
the
reregistration
program.

The
Agency
believes
that
in
reviewing
one
member
of
a
class
or
group,
it
will
be
difficult
to
avoid
considering
other
members
of
the
class/
group
because
information
about
other
members
of
the
class
will
be
relevant
to
the
case
that
is
under
review.
The
review
of
the
case
will
generally
need
to
expand
to
include
a
consideration
of
related
cases,
requiring
more
resources
and
affecting
the
schedule,
unless
the
cases
are
reviewed
together.
Scheduling
concurrent
review
of
related
cases
would
plan
for
this
effect.

The
majority
of
cases
remain
in
chronological
order.
About
one­
third
of
conventional
cases
and
ten
percent
of
antimicrobial
cases
are
in
one
of
the
chemical
classes
or
groups
listed
in
Section
III.
G.
There
are
currently
no
case
groupings
proposed
for
biochemical
or
microbial
cases.

In
the
draft
schedule,
the
review
of
cases
in
the
organophosphate
and
carbamate
classes
would
begin
in
the
first
four
years
of
the
program.
Each
of
these
classes
has
at
least
one
case
that
would
be
scheduled
in
the
first
four
years
using
a
schedule
sorted
only
chronologically,
so
other
cases
would
be
advanced
to
be
reviewed
in
parallel
with
the
regularly
scheduled
cases.
By
August
2006,
the
Agency
will
have
made
final
cumulative
human
health
risk
assessments
and
risk
management
decisions
for
these
classes.
The
area
which
still
requires
further
consideration
is
the
review
of
endangered
species
effects.
To
capitalize
on
the
ongoing
efforts
with
particular
endangered
species
reviews
for
individual
organophosphates
and
carbamates,
the
Agency
will
continue
the
efforts
and
maximize
knowledge
gained
in
ongoing
reviews.
In
recent
years,
EPA
and
stakeholders
have
invested
significant
resources
and
efforts
in
gaining
a
better
understanding
of
these
pesticide
classes.
Addressing
their
endangered
species
effects
early
in
registration
review
will
ensure
that
this
investment
is
not
lost
or
eroded
over
time.
It
would
benefit
all
stakeholders
to
address
these
remaining
issues
in
a
timely
and
consistent
manner
across
each
chemical
class.

In
addition,
EPA
intends
to
schedule
synthetic
pyrethroids
in
years
four
through
six
of
the
program.
The
Agency
is
currently
considering
whether
the
synthetic
pyrethroids
may
share
a
common
mechanism
of
action.
Pending
completion
of
ongoing
research
and
Agency
review
of
outcomes
and
decisions
on
appropriate
grouping(
s),
this
class
may
then
need
early
review.

The
only
antimicrobial
class
that
would
be
scheduled
for
the
first
years
of
the
program
is
bromine
compounds,
scheduled
for
review
in
the
first
year.
Bromine
chloride
would
be
in
year
one
based
on
the
chronological
schedule,
and
there
are
program
efficiencies
in
advancing
the
other
two
members
of
the
class,
bromine
and
inorganic
halides,
to
be
considered
along
with
bromine
4
chloride.

EPA
presented
the
concept
of
considering
chemical
classes
and
groups
within
a
chronological
schedule
to
the
Pesticide
Program
Dialogue
Committee
(
PPDC)
Registration
Review
work
group
on
July
20,
2005
and
included
summary
charts
depicting
certain
chemical
classes
and
groups
for
conventional
chemicals
[
http://
www.
epa.
gov/
oppfead1/
cb/
ppdc/
regisreview/
july05­
presentation.
pdf].
Members
of
the
public
interested
in
commenting
on
this
presentation
may
submit
comments
to
the
PPDC
Registration
Review
meeting
docket:
OPP­
2004­
0014
on
EPA's
public
docket
site:
http://
docket.
epa.
gov/
edkpub/
jsp/
pub/
Welcome.
jsp.
The
direct
link
to
this
docket
is:
http://
docket.
epa.
gov/
edkpub/
do/
EDKStaffCollectionDetailView?
objectId=
0b0007d480225e7b
III.
How
to
Read
This
Schedule
The
draft
EPA
schedule
for
registration
review
is
subdivided
into
four
schedules
for:
(
1)
conventional
pesticides;
(
2)
antimicrobials;
(
3)
biochemicals;
and
(
4)
microbials.
Pesticides
are
organized
into
these
lists
based
on
their
principal
uses.
Some
have
secondary
uses
in
other
categories.

The
draft
schedules
are
sorted
in
the
following
order.
 
The
chronological
order
using
baseline
date,
with
the
oldest
first,
is
the
primary
factor.
 
Members
of
chemical
classes
that
may
be
considered
in
the
first
four
years
are
moved
to
these
years,
and
some
of
the
chronologically­
ordered
cases
are
moved
back
to
make
room
for
these
in
order
to
maintain
the
targeted
number
of
cases
opened
per
year.
 
Beyond
year
four,
cases
are
ordered
in
chronological
order.
Those
that
are
members
of
cases
are
identified,
and
a
projected
year
for
opening
their
review
is
shown.
 
Cases
without
baseline
dates,
which
are
awaiting
reregistration
decisions,
are
sorted
in
ascending
order
based
on
registration
review
case
number.

Each
draft
schedule
has
the
following
columns.

A.
Registration
Review
Case
Number.
The
"
Reg
Rev
Case
#"
column
shows
the
Registration
Review
case
number.
As
explained
in
Section
155.42
of
the
proposed
rule,
a
case
comprises
one
or
more
active
ingredients
that
are
so
closely
related
in
chemical
structure
and
toxicological
profile
as
to
allow
common
use
of
some
or
all
required
data
for
hazard
assessment.
Following
is
the
procedure
EPA
used
to
assign
case
numbers.
 
Cases
numbered
1
to
4999
are
the
same
numbers
as
current
reregistration
case
numbers,
though
active
ingredients
may
have
been
added
to
or
removed
from
these
original
reregistration
cases.
 
5000
to
5999
are
new
cases
for
antimicrobials
that
were
not
subject
to
reregistration
and
that
have
not
been
added
to
an
existing
reregistration
case.
 
6000
to
6999
are
new
cases
for
biochemicals
and
microbials
that
were
not
subject
to
reregistration
and
that
have
not
been
added
to
an
existing
reregistration
case.
5
 
7000
to
7999
are
for
new
conventional
chemical
cases
that
were
not
subject
to
reregistration
and
that
have
not
been
added
to
an
existing
reregistration
case.
 
8000
to
8999
is
for
reregistration
cases
that
have
been
divided
or
restructured.

B.
Registration
Review
Case
Name.
The
"
Registration
Review
Case
Name"
column
shows
the
case
name.
A
case
may
contain
one
or
more
active
ingredients,
so
a
case
may
appear
on
more
than
one
row.

C.
RED
Case
Number.
The
"
RED
Case
#"
column
provides
the
current
reregistration
case
number
for
those
pesticides
subject
to
reregistration.
A
pesticide
is
subject
to
rereregistration
when
products
containing
the
pesticide
active
ingredient
were
registered
before
November
1,
1984.
A
registration
review
case
may
include
active
ingredients
that
were
subject
to
reregistration
and
other
active
ingredients
that
were
not
subject
to
reregistration.
Active
ingredients
without
RED
case
numbers
that
have
registration
review
case
numbers
in
the
1
to
4999
range
were
not
subject
to
reregistration,
but
have
been
added
to
reregistration
cases
where
they
are
structurally
similar
to
other
actives
in
the
case.

D.
PC
Code.
Pesticide
Chemical
(
PC)
Code
is
an
internal
EPA
Office
of
Pesticide
Programs'
number
used
to
identify
all
active
ingredients.

E.
CAS
#.
This
is
the
international
CAS
(
Chemical
Abstracts
Service)
numbering
system
for
chemicals.

F.
Active
Ingredient
Name.
This
is
the
full
name
of
the
active
ingredient.

G.
Chemical
Class.
"
Chem
Class"
provides
codes
for
the
major
chemical
classes
and
the
soil
fumigant
and
rodenticide
groups.
See
Section
II.
E
of
this
document
for
a
description
of
EPA's
conceptual
approach
to
consider
chemical
classes
and
groups
within
a
chronological
schedule.

The
current
chemical
classes
and
groups
are:

BR
Bromine
Compound
CA
Carbamate
CC
Chorine
Compound
CH
Chloroacetanilide
DN
Dinitroaniline
FUM
Soil
Fumigant
group
IM
Imidazolinone
IS
Isothiazolone
OP
Organophosphate
PH
Phenoxy
PY
Pyridine
QU
Quaternary
Compound
RO
Rodenticide
group
SP
Synthetic
Pyrethroid
SU
Sulfonylurea
TO
Triazole
TR
Triazine
H.
Schedule
Change.
This
column
contains
an
asterisk
when
a
case
has
been
removed
from
its
chronologically­
based
position
on
the
list
in
order
to
group
it
with
related
cases
or
to
achieve
other
program
efficiencies
6
I.
Baseline
Date.
This
is
the
date
assigned
to
the
active
ingredient
to
determine
its
chronological
place
in
the
queue
for
registration
review.
See
Section
II.
B
of
this
document
for
a
description
of
baseline
dates.

J.
First
Registered.
This
is
the
date
on
which
EPA
registered
the
first
product
containing
the
active
ingredient.

K.
RED
Status.
Cases
for
which
a
RED
has
been
completed
will
have
the
status
of
"
Completed."
Those
with
IREDs
have
"
IRED"
in
this
column.

L.
RED
Status
Date.
This
column
shows
the
RED
completion
date
or
shows
the
IRED
date
when
"
IRED"
is
shown
in
the
RED
Status
column.

M.
Year
Scheduled.
This
is
the
year
of
the
15­
year
Registration
Review
cycle
in
which
EPA
expects
to
open
the
docket
to
initiate
review
of
the
case.
Except
for
chemical
classes
and
groups
listed
above,
dates
are
given
only
for
cases
scheduled
in
the
first
four
years
of
the
program.

N.
Case
Count.
This
is
a
running
count
of
registration
review
cases.

O.
AI
Count.
This
is
a
running
count
of
active
ingredients.

IV.
Contact
for
Questions
on
Draft
Schedule.
For
questions
on
the
draft
schedule,
contact
Kennan
Garvey,
EPA
Office
of
Pesticide
Programs,
Special
Review
and
Reregistration
Division,
garvey.
kennan@
epa.
gov,
(
703)
305­
7106.

V.
Draft
Registration
Review
Schedule.
The
following
link
accesses
the
draft
Registration
Review
schedule:
http://
www.
epa.
gov/
oppsrrd1/
registration_
review/
draft_
schedule.
htm