Document ID: EPA-HQ-OPP-2003-0252-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-08-12T04:00Z

REVIEW
OF
PESTICIDE
REGISTRATIONS
PURSUANT
TO
FIFRA
§
3(
g)

DISCUSSION
DRAFT
Prepared
for
PPDC
Work
Group
on
Registration
Review
Program
Introduction
FIFRA
section
3(
g)
states,
"
The
registrations
of
pesticides
are
to
be
periodically
reviewed.
The
Administrator
shall
by
regulation
establish
a
procedure
for
the
periodic
review
of
registrations.
The
goal
of
these
regulations
shall
be
a
review
of
a
pesticide's
registration
every
15
years."

Based
on
the
statutory
provision,
some
members
of
the
PPDC
RRWG
recommended
using
15
years
from
the
date
of
the
last
major
regulatory
action
on
a
pesticide
registration
as
the
initial
selection
criterion,
with
further
refinement
based
on
additional
criteria.

Several
other
RRWG
members
suggesting
using
risk
considerations
as
the
primary
criterion
for
assigning
priority
within
the
group
of
pesticide
registrations
scheduled
to
be
reviewed
within
a
15­
year
period.
The
universe
for
this
initial
group
would
be
all
post­
1984
active
ingredient
registrations.
Tiers,
based
on
criteria
related
to
risk,
would
be
used
to
assign
review
priority.
Other
members
suggested
a
hybrid
approach.

Following
is
a
proposal
for
defining
the
scope
of
registration
review.
Cindy
Baker
volunteered
to
draft
this
proposal
for
the
work
group
to
review
before
presenting
it
to
the
full
PPDC.
This
draft
takes
into
consideration
what
the
statute
says,
EPA
resources
and
existing
programs
that
already
address
registration,
reregistration
or
other
activities.
This
proposal
only
deals
with
scope
not
process
questions
like
"
early
off
ramp",
tiering
the
process,
priorities,
etc.
those
should
be
addressed
when
a
process
is
discussed.

Draft
Proposal
I.
Identify
review
candidates
 
EPA
should
inventory
all
pesticide
registrations
and
add
a
field
to
their
database
where
they
can
identify
the
date
of
the
last
registration
action
on
that
registration.
All
pesticide
registrations
should
be
reviewed
to
ensure
they
meet
the
requirements
for
registration.
Congress'
language
refers
specifically
to
the
singular
pesticide.
This
means
the
review
of
an
individual
pesticide.
Registration
Review
does
not
include
inerts
as
they
are
not
pesticide
registrations.
While
it
may
be
helpful
for
the
Agency
to
group
by
active
ingredient
or
common
mechanism,
they
should
start
with
a
list
of
pesticide
registrations.
II.
Registration
Review
Requirements
 
the
"
registration
review"
of
a
pesticide
registration
very
simply
should
be
evaluating
the
pesticide
registration
to
ensure
it
meets
the
requirements
of
registration
at
the
time
the
registration
review
is
conducted.
Registration
review
includes
all
Section
3
and
Section
24
©
registrations.
Registration
Review
is
not
tolerance
reassessment.
Special
Review
and
Reregistration
already
has
and
will
continue
to
have
authority
and
jurisdiction
to
conduct
their
reviews
that
work
should
not
be
duplicated
in
a
registration
review
process.
EPA
should
have
a
formally
adopted
set
of
registration
requirements
that
are
clearly
articulated
in
FIFRA.
The
registration
review
process
will
be
to
see
if
the
pesticide
registration
meets
those
requirements.
It
is
not
a
vehicle
for
significant
additional
generic
data
requirements
to
be
proposed
those
should
be
addressed
through
updates
to
Part
158.
Once
EPA
has
reviewed
a
pesticide
registration
they
send
a
letter
to
the
registrant(
s)
that
states
any
one
or
combination
of
the
following:
1)
the
product
has
been
reviewed
and
is
eligible
to
remain
registered.
2)
Registration
review
indicates
the
need
for
additional
data
to
address
deficiencies
in
the
database.
3)
There
are
modifications
that
must
be
made
to
the
label
for
it
to
remain.
At
the
conclusion
of
any
of
these
actions
the
15­
year
clock
is
restarted.