Final
minutes
August
11
Teleconference
September
25,
2003
Page
1
of
3
Minutes
Registration
Review
Workgroup
Pesticide
Program
Dialogue
Committee
August
11,
2003
Teleconference
Participants:
EPA:
Betty
Shackleford,
Richard
Dumas,
Michael
Nieves,
Philip
Ross,
Tim
Kiely,
Teresa
Downs,
Ingrid
Sunzenauer,
and
Vivian
Prunier
Work
Group
Members:
Britt
Bailey,
Cindy
Baker,
Steve
Kellner,
Therese
Murtagh,
Steve
Rutz,
Julie
Spagnoli,
Roberta
Spitko,
Janine
Rynczak
(
substituting
for
Warren
Stickle),
and
Ray
McAllister
Minutes
of
July
16
Meeting.
In
addition
to
editorial
changes,
the
date
of
the
next
face­
to­
face
meeting
was
corrected.
The
meeting
will
be
held
on
October
28,
the
day
before
the
PPDC
meeting
and
not
on
October
16
as
announced
at
the
meeting
and
stated
in
the
draft
minutes.
It
was
agreed
that
the
October
16
date
would
be
reserved
for
a
teleconference
if
necessary.

Criteria
for
Scheduling
Registration
Review.
The
workgroup
participants
agreed
with
the
finding
in
the
draft
paper
that
the
most
logical
basis
for
scheduling
registration
review
was
the
date
of
the
initial
registration
or
the
reregistration
eligibility
decision.
Participants
said
that
they
needed
a
predictable
schedule
and
an
orderly
process.
Workgroup
members
agreed
to
revise
the
paper
in
time
for
the
next
teleconference.

Scope
of
Registration
Review.
EPA
asked
the
Workgroup
to
clarify
its
suggestion
that
registration
review
does
not
include
inert
ingredients.
FIFRA
section
3(
g)
states
that
the
registrations
of
pesticides
shall
be
periodically
reviewed.
Pesticide
registrations
include
all
the
ingredients
in
a
pesticide
 
active
and
inert.
Accordingly,
the
Agency
believes
that
registration
review
must
account
for
inert
ingredients.
The
Agency
is
trying
to
develop
approaches
to
accomplish
the
review
of
all
pesticide
registrations,
including
inert
ingredients,
and
asks
the
Workgroup's
help
on
this
issue.

What
is
a
Registration
Review
Decision?
All
participants
agreed
that
the
purpose
of
a
registration
review
was
to
determine
whether
a
pesticide
meets
the
requirements
of
FIFRA
section
3(
c)(
5).
Among
other
things,
FIFRA
section
3(
c)(
5)
specifies
that
use
of
the
pesticide
will
not
cause
unreasonable
adverse
effects
on
the
environment.
Under
the
definition
of
"
unreasonable
adverse
effects"
in
FIFRA
section
2(
bb),
EPA
must
consider,
among
other
things,
whether
human
dietary
exposures
to
a
pesticide
meet
the
safety
standard
established
in
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act.

The
participants
discussed
whether
the
Agency
could
conclude
that
a
pesticide's
registration
met
the
requirements
of
FIFRA
section
3(
c)(
5)
if
additional
data
are
necessary
for
a
Final
minutes
August
11
Teleconference
September
25,
2003
Page
2
of
3
registration
review.
The
Agency
reminded
the
Workgroup
that
FIFRA
section
3(
g)(
2)(
A)
states
that
the
Agency
shall
require
submission
of
data
that
are
necessary
for
a
registration
review.
EPA
interprets
this
provision
to
mean
that
the
registration
review
cannot
be
completed
until
examination
of
the
new
data
deemed
necessary
for
a
registration
review
shows
that
the
pesticide
continues
to
meet
the
requirements
of
FIFRA
section
3(
c)(
5).

Workgroup
members
proposed
that
a
registration
review
could
find
that
a
pesticide
registration
was
in
compliance
with
FIFRA
requirements,
including
any
requirement
to
submit
data
necessary
for
a
registration
review,
and
suggested
that
a
decision
as
to
whether
the
pesticide
meets
the
requirements
of
FIFRA
section
3(
c)(
5)
could
be
postponed
until
the
data
have
been
submitted
and
examined.
EPA
agreed
that
under
some
circumstances,
a
registration
review
decision
could
acknowledge
pending
data
that
were
called
in
under
a
special
data
call­
in.
The
review
of
these
data
could
be
separate
from
the
registration
review
of
the
pesticide.

Workgroup
members
suggested
that
EPA
call
in
studies
as
soon
as
the
Agency
recognizes
a
need
for
data
on
a
chemical
or
on
a
group
of
chemicals
that
share
common
attributes.
This
way
the
studies
would
be
available
for
the
pesticide's
registration
review
and
the
review
could
be
completed
on
schedule.

Workgroup
members
suggested
that
registration
review
should
not
include
a
DCI
for
data
requirements
that
have
not
been
codified
in
Part
158
of
40
CFR.
Such
requests
for
data
should
be
made
in
special
DCI
projects.
EPA
acknowledged
that
it
might
be
difficult
for
registrants
to
prepare
for
a
registration
review
when
there
is
uncertainty
about
what
information
will
be
needed
to
support
continued
registration
of
the
pesticide.
If
the
Agency
finds
that
additional
data
are
necessary
for
the
registration
review,
it
would
require
submission
of
such
data,
even
if
the
data
requirement
has
not
been
codified
in
40
CFR
Part
158.

Deciding
on
the
Level
of
Assessment.
EPA
asked
the
workgroup
to
consider
ways
in
which
the
registration
review
process
could
avoid
the
"
one­
size­
fits­
all"
approach
that
the
Agency
used
in
the
reregistration
program.

Workgroup
members
suggested
that
the
Agency
ask
three
questions
to
gauge
the
level
of
assessment:
1)
have
requirements
changed
since
the
last
review?
2)
has
anything
new
happened,
e.
g.,
new
uses,
new
hazard
information,
new
alternatives
3)
have
risk
assessment
methods
or
policy
changed
since
the
last
review?
If
the
answer
to
all
these
questions
is
"
no,"
the
registration
review
would
be
essentially
complete.
If
the
answer
to
one
or
more
of
these
questions
is
"
yes,"
the
Agency
should
consult
with
stakeholders
to
see
whether
the
risk
assessment
should
be
refined
or
if
risk
mitigation
measures
should
be
considered.

Betty
asked
the
Workgroup
to
consider
additional
criteria
for
assessing
the
level
of
assessment
and
suggested
that
members
review
OPP's
proposed
approach
for
registration
review
(
i.
e.,
the
material
presented
to
the
PPDC
in
April).
Final
minutes
August
11
Teleconference
September
25,
2003
Page
3
of
3
Action
Items
°
EPA
to
send
meeting
notes
to
workgroup
members
within
a
week.
°
Workgroup
members
to
revise
the
"
Scope"
paper
and
the
"
Scheduling
Criteria"
paper
before
the
next
meeting.
°
EPA
to
clarify
its
position
on
the
inclusion
of
inert
ingredients
in
registration
review
(
completed;
see
page
1,
paragraph
3
of
these
meeting
notes).
°
EPA
to
provide
a
list
of
active
ingredients
that
shows
the
date
of
the
last
major
action.
°
Cindy
Baker,
Julie
Spagnoli,
Therese
Murtagh
and
Steve
Kellner
will
draft
a
paper
on
"
deciding
the
level
of
assessment"
by
September
12.

Agenda
for
September
24
Teleconference
°
Complete
discussion
of
"
deciding
levels
of
assessment."
°
Begin
discussion
of
stakeholder
involvement
in
the
registration
review
process.
