Document ID: EPA-HQ-OPP-2004-0014-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-05-28T04:00Z

May
25,
2004
Page
1
of
4
Final
Minutes
Registration
Review
Workgroup
Pesticide
Program
Dialogue
Committee
April
14,
2004
Meeting
Crystal
Mall
2,
Arlington
VA
Participants
EPA:
Jay
Ellenberger,
Susan
Lewis,
Kennan
Garvey,
Rich
Dumas,
Carol
Stangel,
Philip
Ross,
TJ
Wyatt,
Elisa
Rim,
David
Stangel
and
Vivian
Prunier
PPDC
Workgroup:
Cindy
Baker
(
by
teleconference),
Steve
Kellner,
Therese
Murtagh,
Julie
Spagnoli,
Ray
McAllister,
Sue
Crescenzi
(
by
teleconference),
George
Wichterman
and
Ted
Head
(
by
teleconference)

Public
attendees:
Janine
Rynczak,
CPDA;
Mary
Beth
Polley,
Pesticide
and
Toxic
Chemical
News,
Phil
Zahodiakin,
Pesticide
Insider;
Daniel
Botts,
Florida
Fruit
and
Vegetable
Association;
Karen
Warkentien,
CSI;
Jim
Kunstman,
PBI
Gordon;
Claudia
Olivierri,
BASF
(
by
teleconference);
and
Burleson
Smith,
USDA
Introduction.
Jay
Ellenberger
described
the
agenda
for
the
meeting.
Susan
Lewis
provided
an
update
of
the
Agency's
progress
towards
drafting
a
proposed
rule.

Minutes
of
March
2,
2004
Meeting.
The
minutes
were
accepted
as
read.

Legislative
history.
Phil
Ross
discussed
the
committee
report
that
addressed
Congressional
intent
for
registration
review.
(
United
States
House
of
Representatives;
Committee
Report
2
of
2;
House
Rpt
104­
669,
Part
1,
Food
Quality
Protection
Act
of
1996.)

Issue
One.
What
action(
s)
initiates
a
pesticide
registration
review?
Before
expending
resources
in
a
pesticide's
registration
review,
the
Agency
would
want
to
know
whether
registrants
intend
to
support
the
pesticide
and
each
of
its
uses.
Other
stakeholders
might
want
to
know
this
as
well.
The
Agency
is
seeking
advice
on
options
for
getting
this
type
of
information
up­
front
in
a
way
that
is
efficient
for
both
the
Agency
and
the
public.

Ray
McAllister
circulated
a
draft
paper
which
can
be
summarized
as
follows:
1.
When
the
Agency
initiates
the
registration
review
program,
it
would
publish
a
master
schedule
listing
all
the
active
ingredients,
ranked
by
date
of
initial
registration
or
reregistration,
and
the
target
year
for
their
review.
The
master
list
would
be
subject
to
comment
and
to
periodic
revision.
May
25,
2004
Page
2
of
4
2.
Each
year
EPA
would
publish
a
list
of
active
ingredients
scheduled
for
registration
review
in
the
coming
year.
For
each
ingredient,
EPA
would
make
available
include
information
including
but
not
limited
to
the
pesticide's
regulatory
history,
registrations
and
registrants,
uses,
pending
registration
or
DCI
actions,
recent
risk
assessments
and
a
bibliography.
3.
The
notice
would
set
a
date
for
the
initiation
of
a
pesticide's
review.
Any
new
data
requirements
or
policies
established
after
this
date
would
not
be
considered
in
the
pesticide's
registration
review.

In
response
to
a
question
from
EPA,
workgroup
participants
acknowledged
that
registrants
could
provide
the
information
identified
in
item
2.
However,
they
asserted
their
belief
that
at
this
step,
it
was
the
Agency's
responsibility
to
show
what
it
has.

The
bibliography
could
include
the
results
of
a
search
of
the
open
literature.
The
bibliography
could
be
either
a
complete
listing
of
all
the
studies
the
Agency
has
in
its
files
or
a
list
of
studies
that
the
Agency
relied
upon
in
making
risk
assessments.
Workgroup
members
preferred
a
complete
listing
of
all
studies.

In
addition
to
the
information
listed
in
the
draft
paper,
the
Agency
could
make
available
risk
assessments
conducted
by
other
agencies
or
governments.

If
the
Agency
has
use
and
usage
information,
it
should
make
this
information
available
as
well.

Issue
Two.
Early
submission
of
test
data
and
other
information
to
support
a
pesticide's
registration
review.
The
Agency
wants
to
receive
pertinent
information
early
in
the
registration
review
process
in
order
to
avoid
redoing
its
risk
assessments.
Such
rework
delays
completion
of
the
pesticide's
review
and
ties
up
scarce
resources.

Cindy
Baker
presented
a
draft
paper
which
can
be
summarized
as
follows:
1)
The
workgroup
acknowledges
of
Agency's
need
for
receiving
pertinent
information
as
early
as
possible
and
to
have
a
public
open
process.
2)
Stakeholders
have
diverse
interests;
EPA
might
develop
a
process
(
e.
g.,
a
list
serve)
for
helping
stakeholders
organize
to
prepare
a
submission.
3)
Ways
to
ensure
timely
submission
 
adhere
to
a
published
schedule;
clearly
articulate
data
needs,
including
an
explanation
of
how
the
Agency
would
use
the
data;
guidelines
regarding
data
quality;
procedures
for
submitting
data;
and
a
contact
person
in
the
Agency
Growers
could
contribute
information
on
use
and
usage
or
perhaps
comment
on
the
reliability
of
use
information
that
the
Agency
placed
in
the
docket.
May
25,
2004
Page
3
of
4
The
workgroup
and
the
Agency
discussed
the
compensability
of
information
that
might
be
submitted
voluntarily
at
this
stage.
If
the
Agency
cites
such
data
in
a
risk
assessment
that
is
the
basis
for
a
regulatory
decision,
then
the
data
is
compensable.

Issue
Five.
What
is
a
registration
review
decision?
In
a
pesticide's
registration
review,
the
Agency
would
determine
whether
a
pesticide
meets
the
requirements
for
registration
under
FIFRA
section
3(
c)(
5).
Additionally,
FIFRA
section
3(
g)(
2)(
A)
stipulates
that
EPA
shall
use
its
authority
under
FIFRA
section
3(
c)(
2)(
B)
to
require
submission
of
data
when
such
data
are
necessary
for
registration
review.

Sue
Crescenzi
presented
a
draft
paper
which
identified
the
possible
outcomes
of
a
registration
review
as
follows:
°
Registration
review
concluded
 
no
changes
in
current
registration.
°
Registration
review
concluded
 
risk
mitigation
or
other
action
required.
°
Registration
review
concluded
 
confirmatory
data
requested.
°
Registration
review
cannot
be
concluded
until
additional
data
are
submitted.
°
Registration
review
concluded;
on
going
generic
data
call­
in
or
other
action
 
registration
review
decision
may
be
revisited
if
necessary.
°
Registration
review
concluded;
active
ingredient
voluntarily
cancelled.
°
Registration
review
concluded;
section
6
cancellation
or
suspension
action.

Phil
Ross
commented
that
the
term
"
confirmatory
data"
might
need
to
be
defined
so
that
its
meaning
is
clear.

Other
issues
In
addition
to
discussing
Issue
5,
Sue
Crescenzi's
draft
paper
addressed
two
other
issues:
"
Procedures
for
addressing
active
ingredients
and
individually
registered
products"
and
"
Options
for
documents
communicating
registration
review
decisions."

With
respect
to
the
first
issue,
the
workgroup
agreed
that
a
registration
review
case
would
include
the
active
ingredient
and
the
pesticide
products
that
contain
the
ingredient.
Registration
review
could
be
a
review
of
product
labels
and
possibly
submission
of
amended
labels.
A
product
with
multiple
active
ingredients
could
be
in
two
or
more
registration
review
cases.

The
workgroup
considered
how
to
expedite
implementation
of
label
changes
that
might
be
needed
a
result
of
registration
review.
The
group
identified
two
possible
bottlenecks
 
delays
in
receiving
Agency
approval
of
amended
labels
and
delays
that
occur
as
old
labels
make
their
way
through
channels
of
trade.
The
delay
due
to
channels
of
trade
may
be
eliminated
by
using
"
electronic
labels"
where
the
purchaser
downloads
the
most
current
label
when
he
buys
the
product.
May
25,
2004
Page
4
of
4
With
respect
to
communicating
registration
review
decisions,
the
workgroup
found
that
registrants
and
the
public
both
need
to
know
the
Agency's
decision.
Registrants
may
need
specific
documentation,
such
as
final
stamped
labels,
data
call­
in
notices,
or
letters
of
agreement
to
signify
the
conclusion
of
registration
review.

Presentation
for
May
PPDC
meeting.
The
workgroup's
presentation
will
cover
the
following
topics:
°
Review
FIFRA
3(
g)
mandate;
recap
October
2003
presentation
 
Julie
Spagnoli
and
Therese
Murtagh
°
Three
issues
discussed
in
2004
 
Ray
McAllister,
Cindy
Baker,
Sue
Crescenzi
°
Next
steps
in
regulation
development
 
EPA
Materials
are
to
be
provided
to
Julie
and
Therese
by
May
10.

If
needed,
there
could
be
a
conference
call
on
May
18.

Rehearsal
for
May
PPDC
meeting.
The
workgroup
will
meet
on
Monday,
May
24
in
the
afternoon,
location
to
be
determined.
The
meeting
will
be
announced
on
the
OPP
website.