1
Registration
Review
Program
Vivian
Prunier
Office
of
Pesticide
Programs
January
20,
2006
2
Registration
Review
Program
°
What
is
Registration
Review?

°
How
does
it
differ
from
Reregistration?

°
Proposed
Program
°
Public
Participation
°
Rule­
making
schedule
3
What
is
Registration
Review?

°
FIFRA
sec.
3(
g)
requires
periodic
review
of
pesticide
registrations
°
Goal
is
to
review
each
pesticide's
registration
every
15
years
4
Congressional
Intent
".
.
.
science
and
the
subsequent
application
.
.
.
[
are]
continuing
to
evolve."

".
.
.
registration
review
.
.
.
.
creates
a
continuous
reregistration
process
.
.
.

[
for
which]
the
Agency
and
the
registrant
can
plan
.
.
."
5
FIFRA
3(
g)
Requirements
°
Procedural
regulations
required
°
Use
existing
authorities
to:

 
call­
in
new
data
 
protect
data
rights
 
cancel
registrations
°
No
limits
on
the
conduct
of
other
FIFRA
reviews.
6
Compare
Registration
Review
to
Reregistration
REREGISTRATION
°
Old
pesticides
°
One­
time
review
°
20
pesticides/
year
°
Process
set
by
law
REGISTRATION
REVIEW
°
All
pesticides
°
15­
year
cycle
°
45
pesticides
a
year
°
Process
set
by
rule
7
Compare
Registration
Review
to
Reregistration
(
cont.)

REREGISTRATION
°
Comprehensive
reviews
°
Start
from
scratch
°
Major
data
gaps
REGISTRATION
REVIEW
°
Update
reviews
as
needed
°
Add
to
what
we
know
°
Fewer
data
needs
8
Elements
of
the
Proposed
Program
°
Unit
of
review
°
Scheduling
reviews
°
Process
for
conducting
the
review
°
Public
participation
°
Registration
review
decision
9
Unit
of
Review
EPA
proposes
"
registration
review
cases"
composed
of
related
pesticide
chemicals
and
the
products
that
contain
them.

 
Past
and
current
practice
 
PPDC
agrees
with
it
10
Scheduling
Reviews
EPA
evaluated
two
options
1.
Chronological
2.
Risk­
based
PPDC
recommended
and
EPA
proposed
chronological
 
Predictable
 
Fair
and
objective
 
Older
pesticides
more
likely
to
have
unrecognized
risks
11
15­
Year
Cycle
Each
year
open
about
45
new
cases
and
complete
about
45
cases
°
Some
completions
will
be
"
E­
Z"
cases
opened
that
year
°
Other
completions
will
be
cases
opened
in
previous
years
12
Proposed
Approach
for
Conducting
the
Review
°
Focus
on
risk
assessment
°
Ask
if
risk
assessment
is
still
acceptable
°
If
new
risk
assessment
is
needed,

determine
if
new
data
are
needed
PPDC
recommended
this
approach
13
New
Decision
Paradigm
°
What's
changed
since
the
last
registration
decision?

°
How
significant
is
this
change?

°
Do
we
need
new
information?

°
Is
the
regulatory
position
likely
to
change
as
a
result
of
the
new
information?
14
Proposed
Process
1.
Announce
schedules
3
years
in
advance
2.
Assemble
information
that
EPA
intends
to
consider
in
its
review
 
Current
registration
status
 
List
of
studies
 
Latest
risk
assessments
and
decision
documents
 
Use/
usage
information
 
Incident
reports
15
Proposed
Process
3.
Place
the
information
in
a
docket
for
public
review
and
comment
4.
Review
the
information,
including
comments
5.
Ask,
"
What's
Changed?
And
is
it
significant?"
16
Proposed
Process
6.
Decide
if
any
new
risk
assessments
are
needed
7.
Decide
if
any
new
data
are
needed
 
Issue
DCI,
generate
&
review
data
8.
Conduct
new
risk
assessments,
if
needed
9.
Decide
if
pesticide
meets
FIFRA
standard
for
registration
17
Registration
Review
Flowchart
Identify/
Assemble
Background
Information
stakeholder
input
Review
information
Decision:

Are
new
assessments
required?

NO
YES
Decision:

Are
data
currently
available?

Conduct
new
assessments
Registrant
provides
data;

YES
NO
Complete
Registration
Review
Decision/
Document
18
Public
Participation
°
For
all
pesticides
in
registration
review,
EPA
will
formally
request
public
input
when
we:

 
open
the
registration
review
docket
 
issue
the
proposed
registration
review
decision
19
Additional
Opportunities
°
EPA
may
also
seek
public
input
on:

 
Draft
risk
assessments
 
Risk
mitigation
20
Consultation
°
Stakeholders
include
registrants,
users,

public
interest
groups,
other
federal,

state,
and
Tribal
agencies
°
EPA
may
consult
with
stakeholders
about
upcoming
or
ongoing
registration
reviews
 
Before
review
­
discuss
pesticide's
use
 
During
review
­
discuss
risk
assessments
and
risk
management
options
21
Transparent
Process
°
A
pesticide's
docket
stays
open
for
the
entire
registration
review
process
until
completion
of
all
actions
required
in
the
final
registration
review
decision.
22
Transparent
Process
°
The
docket
will
include
 
minutes
of
significant
stakeholder
meetings
 
other
new
information
received
during
review
 
comments
on
any
draft
risk
assessments
 
comments
on
proposed
registration
review
decisions
23
Registration
Review
Decision
Determine
whether
a
pesticide
meets
FIFRA
requirements
for
registration
 
Describes
basis
of
FIFRA
finding
 
Identifies
any
risk
mitigation
or
other
action
 
Identifies
any
additional
data
(
issue
DCI)

 
Sets
deadlines
for
completing
required
actions
24
Rule­
making
Schedule
°
Proposal
published
July
13,
2005
°
Comments
period
closed
October
11,

2005
°
Final
Rule
­­
summer
2006
Begin
the
program
 
fall
2006
