Document ID: EPA-HQ-OPP-2004-0014-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-05-28T04:00Z

1
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
Registration
Review
Registration
Review
Report
from
PPDC
Workgroup
Report
from
PPDC
Workgroup
Presentation
to
PPDC
Presentation
to
PPDC
May
25,
2004
May
25,
2004
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
2
Mandate
for
Registration
Review
Mandate
for
Registration
Review
°
FIFRA
3(
g)
provides
for
periodic
review
of
FIFRA
3(
g)
provides
for
periodic
review
of
pesticides
registrations
pesticides
registrations
 
Establish
a
procedure
via
regulation
Establish
a
procedure
via
regulation
 
FIFRA
FIFRA
3(
c(
5)

3(
c(
5)
finding
finding
 
Goal
of
every
15
years
Goal
of
every
15
years
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
3
Background
Background
°
Advanced
Notice
of
Proposed
Rule
Advanced
Notice
of
Proposed
Rule­
Making
Making
(
April
2000)

(
April
2000)

°
PPDC
Registration
Review
workgroup
PPDC
Registration
Review
workgroup
formed
June
2003
formed
June
2003
 
Provide
advice
and
recommendations
on
Provide
advice
and
recommendations
on
design
and
development
of
procedural
design
and
development
of
procedural
regulations
regulations
 
23
members
23
members
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
4
Three
Key
Issues
for
Oct.
2003
Three
Key
Issues
for
Oct.
2003
PPDC
meeting
PPDC
meeting
°
How
will
pesticides
be
scheduled
for
How
will
pesticides
be
scheduled
for
registration
review?

registration
review?

°
Should
there
be
different
levels
of
Should
there
be
different
levels
of
reviews?

reviews?

°
How
should
the
public
participate?

How
should
the
public
participate?
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
5
PPDC
Recommendations
PPDC
Recommendations
Scheduling
Scheduling
°
Predictable
schedule
based
on
15
years
from
Predictable
schedule
based
on
15
years
from
date
of
registration,

date
of
registration,
reregistration
reregistration
or
other
or
other
major
risk
assessment
major
risk
assessment
°
Criteria
for
departure
from
scheduling
should
be
Criteria
for
departure
from
scheduling
should
be
established
established
°
Publish
comprehensive
schedule
with
regular
Publish
comprehensive
schedule
with
regular
updates
updates
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
6
Recommendations
Recommendations
­
Different
Levels
Different
Levels
of
Reviews
of
Reviews
°
Streamlined
review
of
relatively
"
simple"

Streamlined
review
of
relatively
"
simple"

pesticides
e.
g.,
low
toxicity
pesticides
e.
g.,
low
toxicity
 
Also
stable
regulatory
history
and
science
Also
stable
regulatory
history
and
science
°
Pesticides
with
major
complex
issues
Pesticides
with
major
complex
issues
require
a
more
robust
assessment
require
a
more
robust
assessment
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
7
Recommendations
Recommendations
 
Public
Public
Participation
Participation
°
Publish
FR
to
initiate
chemical
specific
Publish
FR
to
initiate
chemical
specific
review
review
°
Seek
stakeholder
input
on
use
Seek
stakeholder
input
on
use
proflies
proflies,

risk
assessments,
risk/
benefit
analysis
and
risk
assessments,
risk/
benefit
analysis
and
risk
mitigation
measures
risk
mitigation
measures
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
8
Public
Participation
Cont.

Public
Participation
Cont.

°
Stakeholder
process
should
be
tailored
to
Stakeholder
process
should
be
tailored
to
the
level
of
review
the
level
of
review
°
Use
of
a
comprehensive
e
Use
of
a
comprehensive
e­
docket
to
docket
to
provide
a
continuum
of
information
provide
a
continuum
of
information
 
History,
status,
public
comments,
previous
History,
status,
public
comments,
previous
regulatory
decisions
regulatory
decisions
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
9
Recent
Activity
of
PPDC
workgroup
Recent
Activity
of
PPDC
workgroup
°
Since
Jan.
2004
held
four
meetings
Since
Jan.
2004
held
four
meetings
°
Discussions
on
three
key
issues
Discussions
on
three
key
issues
 
What
actions
initiate
a
pesticide's
registration
What
actions
initiate
a
pesticide's
registration
review?

review?

 
Early
submission
of
test
data
and
other
Early
submission
of
test
data
and
other
information
information
 
What
is
a
registration
review
decision?

What
is
a
registration
review
decision?
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
10
10
1.
Initiation
of
a
Registration
Review
1.
Initiation
of
a
Registration
Review
Considerations:

Considerations:


Schedules
Schedules
 
both
long
both
long­
term
and
annual
term
and
annual

Background
information
on
each
active
Background
information
on
each
active
ingredient
(
AI)

ingredient
(
AI)


Basis
of
the
review
Basis
of
the
review
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
11
11
Initiation
of
a
Registration
Initiation
of
a
Registration
Review
Review
Recommendations:

Recommendations:


Master
Schedule
Master
Schedule
°
Includes
all
Includes
all
AIs
AIs
subject
to
Registration
subject
to
Registration
Review
and
target
year
for
review
Review
and
target
year
for
review
(
determined
by
date
of
initial
AI
(
determined
by
date
of
initial
AI
registration
or
RED
completion
date)

registration
or
RED
completion
date)

°
Public
comment
period
Public
comment
period
°
Periodic
(
perhaps
annual)

Periodic
(
perhaps
annual)
update
update
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
12
12
Initiation
of
a
Registration
Initiation
of
a
Registration
Review
Review
Recommendations:

Recommendations:


Annual
Schedule
Annual
Schedule
°
Specific
Specific
AIs
AIs
scheduled
for
coming
scheduled
for
coming
year
year
°
FR
Notice
and
OPP's
website
FR
Notice
and
OPP's
website
°
Public
Public
comment
period
comment
period
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
13
13
Initiation
of
a
Registration
Initiation
of
a
Registration
Review
Review
Recommendations:

Recommendations:


Background
Background
for
each
for
each
AI
in
E
AI
in
E­
docket
docket
°
Registrants
Registrants
°
Registered
products
Registered
products
°
Use
Use
sites
sites
°
Tolerances
Tolerances
°
Bibliography
Bibliography
of
data
at
EPA
of
data
at
EPA
°
Outstanding
DCIs
Outstanding
DCIs
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
14
14
Initiation
of
a
Registration
Initiation
of
a
Registration
Review
Review
Recommendations:

Recommendations:


Background
Background
for
each
AI
(
cont.)

for
each
AI
(
cont.)

°
Most
recent
risk
assessment
in
each
Most
recent
risk
assessment
in
each
major
major
category
category
°
Known
Agency
concerns
Known
Agency
concerns
°
Review
activities
in
progress
Review
activities
in
progress
°
Summary
of
adverse
effects
data
Summary
of
adverse
effects
data
°
Significant
a.
i.

Significant
a.
i.
label
issues
if
appropriate
label
issues
if
appropriate
(
e.
g.,
restricted
use
classification)

(
e.
g.,
restricted
use
classification)
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
15
15
Initiation
of
a
Registration
Initiation
of
a
Registration
Review
Review
Recommendations:

Recommendations:


Basis
of
the
Registration
Review
Basis
of
the
Registration
Review
°
Data
and
information
in
hand
at
initiation
Data
and
information
in
hand
at
initiation
of
the
review
would
be
of
the
review
would
be
considered
considered
°
Data
requirements/
policies
in
effect
at
Data
requirements/
policies
in
effect
at
initiation
would
guide
the
initiation
would
guide
the
review
review
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
16
16
Submissions
to
Support
Submissions
to
Support
Registration
Review
Registration
Review
Considerations:

Considerations:


Public
process
open
to
all
possessing
Public
process
open
to
all
possessing
valid,
pertinent
information
valid,
pertinent
information

Information
needed
as
early
as
possible
Information
needed
as
early
as
possible
in
the
process
in
the
process

Reduce
need
for
rework
Reduce
need
for
rework
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
17
17
Submissions
to
Support
Submissions
to
Support
Registration
Review
Registration
Review
Potential
Information
Submitters:

Potential
Information
Submitters:


Registrants
Registrants

Stakeholders
Stakeholders
 
growers,
commodity
growers,
commodity
groups,
public
interest
organizations,

groups,
public
interest
organizations,

other
members
of
the
public
other
members
of
the
public

Government
Agencies
Government
Agencies
 
USDA,
IR4,

USDA,
IR4,

CDC,
etc.

CDC,
etc.


Universities/
Extension
Universities/
Extension
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
18
18
Submissions
to
Support
Submissions
to
Support
Registration
Review
Registration
Review
Recommendations:

Recommendations:


Publish
schedule
for
review
Publish
schedule
for
review

Articulate
guidelines
and
data
needs
Articulate
guidelines
and
data
needs

Describe
data
submission
requirements
Describe
data
submission
requirements

Explain
how
data
will
be
used
Explain
how
data
will
be
used

Issue
DCIs
when
necessary
Issue
DCIs
when
necessary
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
19
19
Submissions
to
Support
Submissions
to
Support
Registration
Review
Registration
Review
Recommendations:

Recommendations:


Provide
a
framework
for
communicating
Provide
a
framework
for
communicating
information
needs
information
needs

Create
and
use
a
Create
and
use
a
listserve
listserve
of
interested
of
interested
stakeholders
for
each
active
ingredient
in
stakeholders
for
each
active
ingredient
in
Registration
Review
Registration
Review
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
20
20
The
Registration
Review
Decision
The
Registration
Review
Decision
Considerations:

Considerations:


Procedures
to
address
Procedures
to
address
AIs
AIs
as
well
as
as
well
as
individual
products
individual
products

Possible
review
conclusions
Possible
review
conclusions

Communication
of
decisions
Communication
of
decisions
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
21
21
The
Registration
Review
Decision
The
Registration
Review
Decision
Procedural
Options:

Procedural
Options:


Registration
review
decision
will
address
both
Registration
review
decision
will
address
both
AI
as
well
as
individual
AI
as
well
as
individual
products
products
°
Two
Two­
step
procedure
similar
to
current
step
procedure
similar
to
current
reregistration
reregistration
process
process
°
Initial
decision
specific
to
AI
Initial
decision
specific
to
AI
°
Later
decisions
for
individual
products
Later
decisions
for
individual
products
°
Registration
review
is
concluded
based
on
Registration
review
is
concluded
based
on
individual
products
with
no
AI
individual
products
with
no
AI­
specific
specific
decision
decision
step
step
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
22
22
The
Registration
Review
Decision
The
Registration
Review
Decision
Recommendations:

Recommendations:


Decision
on
AI
and
its
uses
should
be
followed
Decision
on
AI
and
its
uses
should
be
followed
by
review
of
individual
products.

by
review
of
individual
products.


Product
labels
must
comply
with
decisions
Product
labels
must
comply
with
decisions
made
for
AI
or
particular
uses,
and
with
all
made
for
AI
or
particular
uses,
and
with
all
current
label
policies.

current
label
policies.


Products
with
multiple
Products
with
multiple
AIs
AIs
may
be
reviewed
may
be
reviewed
and
require
updating
more
than
once
in
15
and
require
updating
more
than
once
in
15­
year
year
period.

period.
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
23
23
The
Registration
Review
Decision
The
Registration
Review
Decision
Recommendations:

Recommendations:


Possible
review
conclusions
Possible
review
conclusions
°
"
Easy
Off
"
Easy
Off­
Ramp"

Ramp"
 
No
changes
needed
No
changes
needed
beyond
possible
generic
beyond
possible
generic
label
changes.

label
changes.

°
Mitigation
Required
Mitigation
Required
°
Labels
must
be
amended
to
reflect
Labels
must
be
amended
to
reflect
mitigation
measures.

mitigation
measures.

°
Generic
Generic
label
changes
label
changes
may
also
be
may
also
be
needed.

needed.
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
24
24
The
Registration
Review
Decision
The
Registration
Review
Decision
Recommendations:

Recommendations:


Possible
review
conclusions
(
cont.)

Possible
review
conclusions
(
cont.)

°
Data
Data
Needed
to
Update/
Supplement
Needed
to
Update/
Supplement
Database
Database
°
Sufficient
support
for
continued
Sufficient
support
for
continued
registration
registration
°
Final
or
interim
decision
depending
on
Final
or
interim
decision
depending
on
possible
data
impact
possible
data
impact
°
Product
label
changes
based
on
decision
Product
label
changes
based
on
decision
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
25
25
The
Registration
Review
Decision
The
Registration
Review
Decision
Recommendations:

Recommendations:


Possible
review
conclusions
(
cont.)

Possible
review
conclusions
(
cont.)

°
Data
Data
Required
for
New
Risk
Assessments
Required
for
New
Risk
Assessments
°
Data
call
Data
call­
in
issued
in
issued
°
Review
deferred
Review
deferred
°
Active
ingredient
voluntarily
canceled
Active
ingredient
voluntarily
canceled
 
final
final
decision
pursuant
to
FIFRA
decision
pursuant
to
FIFRA
§
6(
f)

6(
f)

°
FIFRA
FIFRA
§
6
cancellation/
suspension
initiated
6
cancellation/
suspension
initiated
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
26
26
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
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
27
27
The
Registration
Review
Decision
The
Registration
Review
Decision
Recommendations:

Recommendations:


Communication
of
Decision
Communication
of
Decision
°
Letters
to
registrants
Letters
to
registrants
°
DCIs,
when
necessary
DCIs,
when
necessary
°
Public
communication
effort
Public
communication
effort
°
Agreements
between
registrants/
EPA
could
Agreements
between
registrants/
EPA
could
set
conditions
set
conditions
°
Failure
to
amend
labels
could
lead
to
Failure
to
amend
labels
could
lead
to
cancellation
cancellation
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
28
28
Summary
Schedule
for
Rule
Summary
Schedule
for
Rule
Goal:
Program
to
be
in
place
August
2006
Goal:
Program
to
be
in
place
August
2006

Final
Rule
Final
Rule
 
Mid
Mid­
2006
2006

Proposed
Rule
Proposed
Rule
 
February
2005
February
2005

OPP/
EPA
reviews
OPP/
EPA
reviews
 
Summer
2004
Summer
2004

Economic
Analysis
Economic
Analysis
 
Early
Summer
2004
Early
Summer
2004
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
29
29
What
Are
the
Next
Steps?

What
Are
the
Next
Steps?


Develop
the
list
of
all
pesticides
for
the
Develop
the
list
of
all
pesticides
for
the
schedule
of
registration
review
schedule
of
registration
review

Develop
Develop
a
credible
economic
analysis
to
a
credible
economic
analysis
to
implement
the
implement
the
rule
rule

Test
whether
the
proposed
process
for
Test
whether
the
proposed
process
for
conducting
registration
review
is
suitable
conducting
registration
review
is
suitable
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
30
30
Next
Steps
Next
Steps
 
Pilot
the
Process
Pilot
the
Process

OPP
will
conduct
a
pilot
of
the
process
OPP
will
conduct
a
pilot
of
the
process
­­

­­
June
June

Include
mix
of
pesticide
types,
sufficient
number
Include
mix
of
pesticide
types,
sufficient
number

Conduct
cursory
review
of
each
pesticide
Conduct
cursory
review
of
each
pesticide
­
Current
risk
assessments
Current
risk
assessments
­
Uses
and
restrictions
Uses
and
restrictions
­
Whether
there
are
Whether
there
are
unreviewed
unreviewed
studies
or
other
significant
studies
or
other
significant
information
information

Compare
against
current
requirements,
risk
Compare
against
current
requirements,
risk
assessment
methods,
policies
assessment
methods,
policies
­
What's
changed,
how
significant
is
it,
what
needs
to
be
done?

What's
changed,
how
significant
is
it,
what
needs
to
be
done?
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
31
31
Pilot
the
Process
(

Pilot
the
Process
(
con't
con't)


Record
the
findings
Record
the
findings
­
Pesticides
with
no
additional
needs
Pesticides
with
no
additional
needs
­
New
risk
assessments
needed,
e.
g.
Endangered
Species
New
risk
assessments
needed,
e.
g.
Endangered
Species
­
New
studies
needed
New
studies
needed
­
Other
needs
for
OPP
and/
or
registrants
Other
needs
for
OPP
and/
or
registrants

Pilot
should
provide
valuable
information:

Pilot
should
provide
valuable
information:

­
For
estimating
costs
for
economic
analysis
For
estimating
costs
for
economic
analysis
­
Feasibility
of
process
Feasibility
of
process
­
Determine
appropriate
level
of
label
review
Determine
appropriate
level
of
label
review
­
Process
adjustments
Process
adjustments
­
Resource
implications
Resource
implications
May
24
2004,
3:
00
pm
May
24
2004,
3:
00
pm
32
32
Conclusions
Conclusions

PPDC
Work
group's
advice
has
been
PPDC
Work
group's
advice
has
been
beneficial
to
OPP
in
process
formulation
beneficial
to
OPP
in
process
formulation

Pilot
will
provide
useful
information
for
rule
Pilot
will
provide
useful
information
for
rule
and
process
development
and
process
development

Draft
rule
is
scheduled
for
publication
early
Draft
rule
is
scheduled
for
publication
early
2005
2005

Discussion
Discussion