March
2,
2004
Page
1
of
4
Minutes
Registration
Review
Workgroup
Pesticide
Program
Dialogue
Committee
February
2,
2004
Meeting
Crystal
Mall
2,
Arlington
VA
Participants
EPA:
Jay
Ellenberger,
Susan
Lewis,
Richard
Dumas,
Carol
Stangel,
Philip
Ross,
Tony
Kish,
TJ
Wyatt,
Vivian
Prunier
PPDC
Workgroup:
Cindy
Baker
(
via
teleconference),
Wally
Ewart
(
via
teleconference),
Brigid
Klein
(
substituting
for
Steve
Kellner),
Therese
Murtagh,
Julie
Spagnoli,
Ray
McAllister,
Janine
Rynczak
(
substituting
for
Warren
Stickle),
and
Sue
Crescenzi
Public
attendees:
Rebecca
Freeman,
American
Farm
Bureau;
Mary
Beth
Polley,
Pesticide
and
Toxic
Chemical
News,
Phil
Zahodiakin,
Pesticide
Insider;
Robert
M.
Sielaty,
Wright
and
Sielaty.

Introduction.
Jay
Ellenberger
described
the
agenda
for
the
meeting.
The
group
agreed
that
it
would
discuss
issues
one,
two
and
five
at
today's
meeting.

Minutes
of
January
2,
2004
Teleconference.
The
draft
minutes
were
amended
to
add
or
correct
participants'
names
and
affiliations.

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.

Options
include:
°
Agency
publishes
schedule.
Agency
notifies
registrants
by
letter
that
it
has
commenced
its
review.
No
action
required
from
stakeholders
at
this
point.
Stakeholders
do
not
provide
input
until
the
results
of
the
review
are
available.

°
Agency
publishes
schedule.
Agency
identifies
documents
that
it
will
evaluate
in
the
review
and
places
this
information
(
i.
e.,
either
a
list
of
documents
or
the
documents
themselves)
in
the
docket
for
registrant
and
stakeholder
review.

°
Agency
publishes
schedule.
A
pesticide's
registration
review
begins
when
the
Agency
March
2,
2004
Page
2
of
4
receives
notification
from
registrants
regarding
their
intent
to
support
the
pesticide's
registration
review.
In
their
evaluation
of
this
option,
stakeholders
said
that
payment
of
annual
maintenance
fees
is
sufficient
demonstration
of
intent
to
support
the
registration.
Accordingly,
submission
of
additional
notification
would
not
be
unnecessary.

The
workgroup
supported
the
second
option.
The
workgroup
discussed
the
documentation
that
the
Agency
might
provide
under
this
option.
The
information
might
include
copies
of
labels
and/
or
a
list
of
registered
uses;
the
RED
or
TRED
for
the
pesticide;
and
copies
of
the
most
recent
risk
assessments
for
each
scientific
discipline.
There
was
brief
mention
of
including
alist
of
data
requirements
for
the
registered
uses
of
the
pesticide
and
a
list
of
studies
that
had
been
submitted,
but
these
ideas
were
not
pursued.

The
workgroup
acknowledged
that
the
Agency
might
have
to
upgrade
its
information
management
systems
to
support
this
activity.

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.

Options
include:
°
Stakeholders
take
no
action
until
they
have
the
results
of
the
Agency's
review.

°
When
it
initiates
a
registration
review,
the
Agency
issues
a
Data
Call­
in
Notice
requiring
the
submission
of
any
existing
information
that
is
pertinent
to
the
pesticide's
registration
review.
This
information
might
include
studies
that
were
submitted
to
foreign
governments
in
support
of
uses
not
registered
in
the
US
or
in
response
to
additional
requirements
imposed
by
other
governments,
risk
assessments
prepared
by
other
governments,
or
information
on
use
and
usage.

°
After
the
Agency
has
assembled
the
information
it
will
review
 
but
before
it
has
evaluated
it
 
convene
a
"
SMART"
meeting
with
stakeholders
to
discuss
the
Agency's
need
for
additional
information
and
whether
stakeholders
possess
information
responsive
to
the
Agency's
needs.

°
After
the
Agency
has
publically
identified
the
information
it
has
assembled
for
a
pesticide's
registration
review,
registrants
and
other
stakeholders
respond
by
providing
a
list
of
studies
or
other
information
that
is
pertinent
to
the
registration
review.

Because
of
the
novelty
of
the
last
option,
workgroup
members
needed
to
consult
with
their
constituencies.
Questions
included:
What
items
belong
on
such
a
list?
How
does
a
registrant
decide
whether
to
list
an
item?
Are
there
confidentiality
or
other
issues
related
to
releasing
such
a
list?
March
2,
2004
Page
3
of
4
The
workgroup
then
discussed
early
submission
of
stakeholder's
information
that
might
pertain
to
the
use
and
usage
of
a
pesticide.
The
Agency
would
like
to
know
 
before
it
conducts
a
risk
assessment
 
whether
actual
usage
rates
are
lower
than
the
labeled
rates.
Stakeholders
want
to
avoid
assembling
such
information
until
it
is
reasonable
certain
that
this
information
is
needed
to
preserve
the
use
of
the
pesticide.
However,
if
stakeholders
see
what
the
Agency
will
be
evaluating
in
the
registration
review,
they
can
decide
for
themselves
if
additional
information
should
be
provided
to
support
a
pesticide
or
a
particular
use.

USDA
could
need
several
years'
lead
time
if
it
is
going
to
include
a
particular
pesticide
in
its
PDP
or
NAS
programs.
Growers
also
needed
a
long
lead
time
to
identify
their
issues
and
get
organized.

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.
The
workgroup
has
discussed
a
number
of
possible
scenarios
that
might
represent
the
completion
of
registration
review.

The
workgroup
acknowledged
that
a
DCI
for
data
needed
for
a
risk
assessment
could
not
be
an
endpoint
for
the
registration
review.
In
such
cases,
completion
of
the
registration
review
would
be
deferred
until
the
data
are
submitted
and
evaluated.
The
workgroup
considered
what
a
"
needs
a
DCI"
determination
would
be
called.
The
Agency's
workgroup
had
been
using
the
term
"
interim
decision,"
but
it
is
possible
that
other
terms
could
be
used
to
characterize
such
cases.
Another
concern
was
that
additional
issues
might
arise
during
while
a
registration
review
decision
was
pending
and
that
these
issues
might
further
delay
completion
a
registration
review.

Action
Items:
°
Ray
McAllister
volunteered
to
lead
the
write
up
of
Issue
One.

°
Cindy
Baker,
Julie
Spagnoli,
and
Sue
Crescenzi
to
explore
the
issues
relating
to
having
registrants
submit
bibliographies
(
an
option
in
Issue
Two).
Therese
Murtagh
volunteered
to
work
with
them.

°
Sue
Crescenzi
has
the
lead
for
writing
up
Issue
Five.

°
TJ
Wyatt
will
prepare
an
e­
mail
asking
workgroup
members
to
consider
costs
and
benefits
of
the
options
for
each
of
the
three
issues.

Schedule
for
Workgroup
Meetings
and
Teleconferences.
The
next
meeting
is
scheduled
for
Tuesday
March
2.
However,
it
may
be
necessary
to
change
the
date
of
this
meeting
 
possibly
to
the
preceding
day.
March
2,
2004
Page
4
of
4
