REGISTRATION
REVIEW
REGISTRATION
REVIEW
Report
from
PPDC
Workgroup
Report
from
PPDC
Workgroup
Presentation
to
PPDC
October
29,
2003
Registration
Review
Registration
Review
Background
Background

FIFRA
sec.
3(
g)
provides
for
periodic
review
of
pesticides
registrations
­
goal
of
every
15
years
­
establish
a
procedure
via
regulation
­
use
data
call­
in
authority
to
require
data
as
necessary
­
other
provisions
of
FIFRA
apply

Advanced
Notice
of
Proposed
Rule­
Making
(
April
2000)
 
EPA's
initial
concept
and
solicit
comments

EPA
presentation
at
April
2003
PPDC
meeting

Charge
to
form
workgroup
to
make
recommendations
on
key
issues

Workgroup
formed
in
June
2003
Background
Background
continued
continued

PPDC
Workgroup
organized
in
June
2003
 
23
members;
diverse
membership
 
Series
of
public
meetings
held
June
 
October
2003
to
discuss
and
make
recommendations
for
three
key
issues:

­
Criteria
for
scheduling
registration
reviews
­
Should
there
be
multiple
levels
of
the
rigor
of
review
depending
on
the
pesticide
and
its
issues?

­
What
should
be
the
stakeholder
participation
process?
Background
Background
continued
continued

Other
topics
included:

 
What
constitutes
a
registration
review
decision?

 
How
to
ensure
that
a
pesticide's
registration
is
kept
up
to
date
 
registration
review
should
be
a
safety
net,
not
a
catch­
all
 
Accounting
for
inert
ingredients
in
registration
review.
Workgroup
Mission
and
Operation
Workgroup
Mission
and
Operation

Mission:
provide
advice
and
recommendations
on
design
and
development
of
procedural
regulations
for
registration
review

Three
key
issues:

°
How
should
pesticides
be
scheduled
for
review?

°
Should
there
be
different
levels
of
review?

°
How
should
the
public
participate?


Four
public
meetings
June
­
October
2003

Discussion
led
to
recommendations;
did
not
seek
group
consensus
Considerations:

Considerations:

­
1200
Pesticides
/
20K
Products
subject
to
registration
review
1200
Pesticides
/
20K
Products
subject
to
registration
review
­
Universe
of
pesticides
continually
changing
Universe
of
pesticides
continually
changing
­
Many
chemically
related
pesticides
Many
chemically
related
pesticides
­
Work
group
considered
other
alternatives,
e.
g..,
"
worst
first"

Work
group
considered
other
alternatives,
e.
g..,
"
worst
first"

ISSUE
1
ISSUE
1
How
Will
Pesticides
be
Scheduled
How
Will
Pesticides
be
Scheduled
for
Registration
Review?

for
Registration
Review?
Scheduling
Scheduling
continued
continued
­
Recommendations:

­
The
administrative
procedures
for
scheduling
registration
review
should
not
be
subjective,

resourceintensive
or
time­
consuming.

­
Predictable
schedule
generally
based
on
15
years
from
date
of
registration,
reregistration,
or
other
major
risk
assessment
­
Specific
criteria
for
departure
from
scheduling
should
be
established
by
regulation.

­
Comprehensive
schedule
published
in
federal
register
and
on
EPA's
website
with
regular
updates
Issue
2
Issue
2
Different
Levels
of
Review
Different
Levels
of
Review
Considerations:


Not
all
chemicals
pose
the
same
risks

Scope
of
the
program
mandates
efficient
use
of
resources

Changes
in
data
requirements,
database,

adverse
effects
data,
science
policies,
and
use
and
usage
profiles
Completion
of
Registration
Review
Deficiencies
in
registration?

Active
Ingredient:
Additional
data
needed,
data
gaps
End­
use
products:
data
gaps,

acceptability
of
inerts,
labeling
New
data
(
studies,

adverse
effects)
or
new
statutory
or
regulatory
assessment
standards?

New
Uses
or
significant
changes
in
uses
since
initial
registration
or
reregistration?
Assessments
current?

Conduct
new
assessment
Assessments
acceptable?

(
No
unreasonable
adverse
effects?)

Additional
data,

refinements,
mitigation
Revised
assessment
acceptable?

Risk­
benefit
assessment
and
final
decision
acceptable?
Initiate
cancellation
or
suspension
of
unacceptable
uses
in
accordance
with
FIFRA
Section
6
Compliance
with
Data
requirements,

labeling
changes?

Initiate
cancellation
or
suspension
of
noncompliant
products
in
accordance
with
FIFRA
Section
6
Yes
Yes
Yes
Yes
Yes
Yes
Request
data,

and/
or
label
changes
Yes
Cancellation
or
suspension
No
No
No
No
No
No
No
Yellow
boxes
indicate
stakeholder
inputs
Blue
boxes
indicate
decision
points
FR
Notice
to
announce
initiation
of
Review
and
solicit
stakeholder
input;

Establish
public
docket
Yes
No
Level
of
Review
Level
of
Review
continued
continued
Recommendations:


Registration
Review
process
should
allow
for
a
streamlined
review
for
relatively
"
simple"
pesticides
e.
g.,
low
toxicity,
minimal
usage

Streamlined
process
for
pesticides
with
stable
regulatory
history
and
science

Pesticides
with
major
complex
issues
would
require
a
more
robust
assessment
ISSUE
3
ISSUE
3
How
can
meaningful
public
How
can
meaningful
public
participation
be
accomplished?

participation
be
accomplished?


Considerations:

 
Registration
review
would
benefit
from
early
participation
by
all
stakeholders.

 
Stakeholders
need
a
predictable
schedule
to
prepare
for
and
participate
in
registration
review.

 
Stakeholders
need
an
understandable
process
where
opportunities
and
expectations
for
public
participation
are
clear.

Recommendations:


Stakeholder
input
would
be
sought
on
use
profiles,
risk
assessments,

risk/
benefit
analyses,
and
risk
mitigation
measures.


Stakeholder
process
should
be
tailored
to
the
level
of
review.


Modern
electronic
technology
should
be
used
to
facilitate
stakeholder
access
to
information

Use
of
a
comprehensive
e­
docket
should
be
expanded
to
provide
a
continuum
of
information
including
history,
status,
public
comments
and
all
previous
regulatory
decisions
of
a
pesticide

Publish
a
Federal
Register
Notice
to
initiate
chemical
specific
registration
review
Public
Participation
Public
Participation
continued
continued
General
Recommendations
General
Recommendations

The
review
does
not
supersede
or
replace
EPA's
other
authorities
under
FIFRA
(
data
call­
ins,
special
review,

suspension,
cancellation,
etc.).


Registration
review
can
be
considered
a
"
safety
net"
so
that
every
registration
is
reviewed
periodically
to
assure
that
no
administrative
deficiencies
or
risk­
related
issues
are
overlooked.


The
degree
of
reassessment
should
not
be
a
"
one­
size­

fitsall
process

FRN
should
be
published
to
announce
annual
or
biannual
updates
to
the
schedule.


Schedule
should
be
made
available
on
the
EPA
website
well
in
advance.


A
predictable
process
and
schedule
for
the
submission
of
data
by
stakeholders

Ensure
the
review
of
chemicals
with
outstanding
issues
(
data
call
ins,
etc.)
will
be
completed
in
a
timely
manner
GENERAL
RECOMMENDATIONS
GENERAL
RECOMMENDATIONS
­
continued
continued
Additional
Issues
Additional
Issues
°
What
constitutes
a
registration
review
decision?

Whether
a
pesticide
meets
the
requirements
of
FIFRA
section
3(
c)(
5)

°
How
to
ensure
that
a
pesticide's
registration
is
kept
up
to
date
 
registration
review
should
be
a
safety
net,
not
a
catch­
all
°
Accounting
for
inert
ingredients
in
registration
review.
Additional
Issues
Additional
Issues

What
constitutes
a
current
assessment?


Possible
criteria:

 
Dietary
assessment:
includes
all
current
food
uses
 
For
assessments
that
are
not
dietary
(
residential,

ecotox,
endangered
species
concerns,

occupational)
includes
uses
that
are
the
significant
sources
of
exposure
 
No
indications
of
significant
new
or
increased
adverse
effects
PPDC
Discussion:

PPDC
Discussion:


Questions

Discussion
of
key
issues
and
workgroup's
recommendations

PPDC
recommendations
