Document ID: EPA-HQ-OPP-2003-0252-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-08-12T04:00Z

Draft
Minutes
Registration
Review
Workgroup
Meeting
Pesticide
Program
Dialogue
Committee
Sheraton
Crystal
City
July
16,
2003
Participants:
EPA:
Jay
Ellenberger,
Betty
Shackleford,
Richard
Dumas,
Vivian
Prunier,
Margie
Fehrenbach
Workgroup
Members:
Cindy
Baker,
Britt
Bailey
(
via
teleconference),
Carolyn
Brickey,
Patti
Bright,
Sue
Crescenzi,
Ted
Head,
Steve
Kellner,
Gary
Libman
(
via
teleconference),
Therese
Murtaugh;
Bob
Rosenberg,
Troy
Seidel,
Julie
Spagnoli,
Roberta
Spitko,
Warren
Stickle,
Ray
McAllister
(
substituting
for
Jay
Vroom),
George
Wichterman,
Eric
Olson,
and
Dan
Botts.

Minutes
of
the
July
2
teleconference
were
amended
to
add
the
name
of
Steve
Kellner
as
a
participant
in
the
conference.

Lessons
Learned
from
Reregistration
°
FIFRA
section
4
clearly
stated
what
registrants
must
do
in
Phases
2
and
3.

°
The
reregistration
process
imposed
the
same
procedure
for
all
ingredients.
There
was
no
way
to
abbreviate
the
procedure
when
a
pesticide
posed
very
little
risk.

°
Rules
about
what
constituted
the
current
standard
of
registration
seemed
to
change
while
a
pesticide
was
undergoing
reregistration.
Data
gaps
should
be
recognized
early
in
the
process.
There
was
a
concern
that
EPA
required
studies
for
which
there
is
no
clear
protocol.

°
When
a
pesticide
in
the
reregistration
program
was
also
undergoing
Special
Review,
the
RED
was
delayed
until
completion
of
the
Special
Review.
"
Speed
bumps"
that
delayed
completion
of
a
RED
included
law
suits
and
disputes
over
data.

°
After
the
RED
for
an
active
ingredient,
end­
use
products
are
reregistered.
But
follow
through
has
not
been
systematic.
For
example,
product
labels
are
often
not
consistent
with
the
RED
or
with
the
Agency's
labeling
policies.
Agency
doesn't
track
or
report
the
completion
of
product
reregistration.

°
Reregistration
was
not
open
enough
for
non­
registrants
(
particularly
public
interest
groups)
to
participate
early
in
the
process.
Early
involvement
of
CDC
or
others
knowledgeable
about
public
health
uses
of
a
pesticide
would
have
been
helpful.
Early
involvement
of
Fish
and
Wildlife
Service
regarding
endangered
species
issues
and
growers
or
other
stakeholders
regarding
use
practices
would
have
been
useful.
2
°
Publishing
reregistration
schedules
in
advance
and
a
clearly
delineating
public
participation
procedure
worked
well
for
registrants.

°
Suggested
it
would
be
helpful
to
have
CDC
and
the
Public
Health
Corps
participate
in
the
Workgroup.

Scope
of
Registration
Review
°
What
is
a
Registration
Review
Decision?
Is
it
an
assessment
whether
a
pesticide
meets
current
standards
of
registration
or
is
it
a
process
that
must
be
pursued
until
resolution
of
all
issues
regarding
the
continued
registration
of
the
pesticide?
 
If
it
is
the
former,
the
review
would
focus
on
changes
that
have
occurred
since
the
last
review
of
the
pesticide.
Issues
identified
in
the
registration
review
would
be
pursued
under
"
other
provisions
of
the
Act."
For
example
pesticides
with
risk
issues
could
be
referred
to
special
review.
 
If
it
is
the
latter,
EPA
will
not
be
able
to
complete
registration
reviews
on
80
chemicals
per
year.

°
What
is
EPA
supposed
to
review?
The
options
are:
 
individual
end­
use
product
on
the
15th
anniversary
of
its
original
registration;
 
each
active
ingredient;
 
groups
of
chemically
related
active
ingredients,
e.
g.
reregistration
cases;
 
group
active
ingredients
by
some
other
criteria,
e.
g.,
chemicals
that
share
a
common
mechanism
of
toxicity,
or
pesticides
used
for
a
common
purpose
such
as
corn
herbicides.

The
group
favored
the
chemical
case
approach,
but
needed
more
discussion
of
how
to
set
the
anniversary
date
for
a
chemical
case
as
individual
members
of
the
case
would
have
different
dates
of
initial
registration.

The
group
suggested
that
end­
use
products
should
be
considered
in
registration
review
but
were
not
certain
how
to
do
this.

Should
24(
c)
registrations,
EUPs
and
section
18
emergency
exemptions
be
included
even
though
these
uses
are
not
section
3
registrations?

Participants
questioned
how
to
approach
registration
review
of
products
that
contain
multiple
active
ingredients.

°
Inclusion
of
inert
ingredients
in
registration
review.
Participants
offered
a
range
of
opinions:
 
Inert
ingredients
aren't
registered,
so
they
should
not
be
considered
in
registration
review;
3
 
Consider
inert
ingredients
when
reviewing
end­
use
products;
 
Use
other
procedures
to
manage
issues
relating
to
inert
ingredients,
e.
g.,
classify
the
ingredient
as
a
"
List
One
Inert"
(
i.
e.,
inert
ingredient
that
must
be
identified
on
the
product
label).

°
Update
40CFR
Part
158
so
registrants
know
what
the
requirements
are.

°
What
should
be
the
basis
of
a
decision
that
a
pesticide's
registration
meets
current
standards?
Participants
offered
a
range
of
opinions:
 
A
determination
that
it
meets
all
the
requirements
of
40
CFR
Part
158;
 
A
determination
that
end­
use
product
labels
are
consistent
with
the
pesticide's
current
risk
assessment
and
labeling
policy;
 
Focus
on
what
has
changed
since
the
last
assessment
of
the
pesticide
with
respect
to
new
data
requirements
and/
or
changes
in
risk
standards.
Look
at
all
areas,
e.
g.,
even
recently
completed
tolerance
assessments,
to
see
if
anything
has
changed.
 
Registration
review
is
not
intended
to
be
a
comprehensive
review
like
reregistration
or
tolerance
reassessment.

°
Mechanisms
for
keeping
a
pesticide's
registration
up
to
date.
Participants
identified
several
approaches
for
assuring
that
a
pesticide's
registration
meets
current
standards:
 
When
it
reviews
a
new
use
application,
the
Agency
should
review
the
entire
label,
not
just
the
proposed
addition,
and
insist
that
all
aspects
of
the
label
be
brought
to
current
standards.
 
When
it
reviews
a
new
use
application,
the
Agency
should
assure
that
the
data
supporting
the
pesticide
is
consistent
with
current
standards.
 
When
the
Agency
identifies
a
new
data
requirement,
or
new
data
requirements
are
imposed
by
legislation
such
as
the
endocrine
disruptor
tests,
the
Agency
should
conduct
special
data
call­
ins
to
acquire
the
data.
Otherwise
the
data
won't
be
available
for
the
registration
review.
 
The
Agency
could
conduct
label
improvement
programs
to
bring
labels
to
current
standards.
Otherwise,
labels
would
have
to
be
updated
during
(
or
as
a
result
of)
registration
review.
This
could
result
in
an
uneven
playing
field
as
the
labels
of
competing
products
would
not
be
updated
until
they
undergo
registration
review.
 
Submit
exposure
information
(
i.
e.,
non­
guideline
data)
so
that
it
is
available
when
the
pesticide
begins
its
registration
review.

Scheduling
Registration
Reviews
°
Participants
generally
agreed
that
there
should
be
clear
and
predictable
schedules
for
registration
reviews.
Stakeholders
need
to
know
when
the
clock
starts.

°
Criteria
for
scheduling
registration
reviews:
4
 
Participants
generally
agreed
that
setting
schedules
by
date
of
last
comprehensive
review
would
result
in
a
stable,
predictable,
and
largely
workable
schedule.
 
Other
participants
proposed
scheduling
the
worst
first.
Participants
acknowledged
that
it
might
be
difficult
to
decide
what
attributes
should
be
used
in
deciding
which
pesticides
are
"
the
worst."
It
was
noted
that
the
risks
posed
by
pesticides
registered
prior
to
1985
were
addressed
in
the
reregistation
and
tolerance
reassessment
programs.
 
Some
participants
suggested
that
pesticides
with
the
oldest
and
least
comprehensive
reviews
be
scheduled
first:
pesticides
with
no
REDs
(
i.
e.,
registered
after
1984)
and
no
tolerance
reassessment;
pesticides
with
no
REDS,
but
with
tolerance
reassessment;
and
pesticides
with
REDs
but
no
tolerance
reassessment.
 
New
testing
requirements
should
be
considered
in
setting
priorities
for
registration
review.

°
The
Workgroup
asked
the
Agency
to
provide
a
list
of
active
ingredients,
grouped
by
chemical
case
and
ranked
by
date
of
initial
registration.

Public
Participation
in
Registration
Review
°
The
registration
review
process
should
be
clear
and
understandable.
Stakeholders
should
know
when
they
will
be
able
to
participate
in
the
process.

°
Information
should
be
publically
available
on
the
Agency's
website.

°
All
stakeholders
should
be
able
to
participate
from
the
outset
of
the
process.

°
There
should
be
a
clear
accounting
scheme
to
show
what
has
been
completed.

Action
Items
°
Cindy
Baker
will
draft
a
paper
on
scope
of
registration
review
and
e­
mail
it
to
workgroup
members.

°
Sue
Crescenzi
will
draft
a
paper
on
scheduling
options
and
e­
mail
it
to
workgroup
members.

°
EPA
will
provide
list
of
active
ingredients
ranked
by
date
of
initial
registration.

Next
Meetings
°
Teleconference
on
Monday,
August
11
from
2
to
4
p.
m.
EDT.

°
Teleconference
on
Wednesday,
September
24
from
2
to
4
p.
m
EDT.
5
°
Meeting
on
Thursday,
October
16
from
9
a.
m.
to
5
p.
m.
in
Crystal
City.