Document ID: EPA-HQ-OPP-2002-0296-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-01-29T05:00Z

Page
1
of
8
Options
Paper:

Data
Submitter
Rights
for
Data
Submitted
in
Support
of
Tolerance
Actions
As
part
of
the
Food
Quality
Protection
Act
of
1996,
Congress
amended
section
408(
i)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
to
address
exclusive
use
and
compensation
rights
for
data
submitted
to
EPA
in
support
of
tolerance
and
tolerance
exemption
actions.
This
paper
does
not
address
the
issue
of
data
that
are
"
voluntarily
submitted"
to
the
Agency.
The
Agency
is
currently
evaluating
how
to
implement
this
new
provision
and
is
seeking
public
comment.

I.
Background
EPA
is
responsible
under
section
3
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
for
registering
pesticide
products
on
the
basis
of
scientific
data
or
other
information
adequate
to
show
that,
among
other
things,
the
products
will
not
pose
unreasonable
adverse
effects
on
the
environment.
EPA
may
require
that
applicants
and
registrants
submit
data
to
the
Agency
to
assess
whether
a
pesticide
should
be
registered
or
continue
to
be
registered.
Persons
wanting
to
obtain
or
maintain
a
registration
for
a
pesticide
product
must
submit
an
application
package
consisting
of
information
relating
to
the
identity
and
composition
of
the
product,
and
supporting
data
or
a
citation
to
supporting
data.

FIFRA
section
3(
c)(
1)(
F)
extends
exclusive
use
or
compensation
rights
to
persons
("
original
data
submitters")
who
submit
proprietary
data,
in
support
of
an
application
for
registration,
reregistration,
or
experimental
use
permit,
or
to
maintain
an
existing
registration.

Applicants
who
cite
supporting
data
previously
submitted
to
the
agency
by
the
original
data
submitter,
must
certify
that
an
offer
of
compensation
has
been
made
to
the
original
data
submitter
Page
2
of
8
or
that
the
submitter
has
granted
permission
to
cite
data.
In
the
case
of
"
exclusive
use"
data,
the
applicant
must
obtain
the
permission
of
the
original
data
submitter
and
certify
with
the
Agency
that
the
applicant
has
obtained
written
authorization
from
the
original
data
submitter.
If
an
applicant
or
registrant
fails
to
comply
with
these
requirements,
the
application/
registration
is
subject
to
denial
or
cancellation.

Since
FIFRA
places
an
obligation
on
the
Agency
to
ensure
that
the
original
data
submitter
is
offered
compensation
for
the
use
of
data,
a
Pesticide
Data
Submitters
List
was
developed
to
assist
applicants
in
fulfilling
their
obligation.
The
Data
Submitters
List
is
a
compilation
of
names
and
addresses
of
original
data
submitters
who
wish
to
be
notified
and
offered
compensation
for
use
of
their
data.
The
Data
Submitters
List
is
available
via
the
Internet
at
http://
www.
epa.
gov/
opppmsd1/
DataSubmittersList.

For
pesticides
that
may
remain
in
or
on
food
or
animal
feed,
a
maximum
residue
level
(
tolerance)
must
be
established.
In
considering
a
tolerance
action,
EPA
reviews
certain
types
of
data
on
a
pesticide
to
determine
if
residue
limits
will
be
safe.
Prior
to
passage
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996,
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
did
not
contain
a
data
compensation
and
exclusive
rights
provision.
Nonetheless,
EPA
has
consistently
taken
the
position
that
data
submitted
to
support
a
tolerance
or
tolerance
exemption
are
entitled
to
exclusive
use
or
compensation
if
the
data
otherwise
meet
the
requirements
of
section
3
of
FIFRA.
Specifically,
the
data
must
be
submitted
in
support
of
a
registration
or
reregistration
action
or
must
otherwise
be
submitted
to
support
or
maintain
registration.
Because
most
"
tolerance­
related"
data
are
submitted
to
support
registration
actions,
these
data
generally
are
compensable
under
FIFRA.
Page
3
of
8
II.
Amendments
to
the
Law
In
1996,
Congress
amended
the
FFDCA
to
add
a
new
section
408(
i)
that
explicitly
addresses
compensation
and
exclusive
use
rights
for
data
submitted
to
support
tolerances
and
tolerance
exemption.
Congress
provided
that
such
data
are
compensable
"
to
the
same
extent"

provided
in
section
3
of
FIFRA.
However,
the
statute
gives
no
further
guidance
as
to
whether
this
provision
is
simply
intended
to
codify
EPA's
current
practice,
or
whether
Congress
intended
to
expand
data
compensation
rights
to
those
data
that
currently
do
not
enjoy
compensation
or
exclusive
use
rights.
The
pertinent
part
of
the
statutory
language
reads:

408(
i)
Confidentiality
and
Use
of
Data.
 
(
1)
General
rule.­
Data
and
information
that
are
or
have
been
submitted
to
the
Administrator
under
this
section
or
section
409
in
support
of
a
tolerance
or
an
exemption
from
a
tolerance
shall
be
entitled
to
confidential
treatment
for
reasons
of
business
confidentiality
and
to
exclusive
use
and
data
compensation
to
the
same
extent
provided
by
sections
3
and
10
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act.

EPA
may
receive
data
submitted
in
support
of
tolerance
or
tolerance
exemption
actions
that
are
not
submitted
to
support
FIFRA
registration
actions.
Specifically,
data
submitted
by
manufacturers
of
other,
non­
pesticidal
ingredients
petitioning
for
the
issuance
of
a
tolerance
or
exemption
and
data
submitted
by
persons
petitioning
for
the
issuance
of
a
tolerance
for
a
pesticide
on
imported
food
are
generally
not
submitted
in
connection
with
any
action
under
FIFRA.
Under
FIFRA
such
data
would
not,
therefore,
qualify
for
exclusive
use
or
compensation
status.

While
the
statute
is
silent
on
this
matter,
the
legislative
history
in
the
House
Committee
on
Page
4
of
8
Commerce
Report
accompanying
H.
R.
1627
(
the
bill
that
was
enacted
as
the
FQPA
of
1996)

provides
that
"[
the
Committee
intends
that
this
section
apply
to
data
submitted
to
EPA
prior
to
enactment,
under
old
section
408
or
409,
including
data
submitted
under
EPA
guidelines
by
manufacturers
of
inert
ingredients
of
pesticides"
(
H.
R.
No.
669,
104th
Cong.,
2nd
Sess.,
pt
2,
at
50,
1996).
Since
most
data
submitted
by
manufacturers
of
other
ingredients
are
not
subject
to
protection
under
section
3
of
FIFRA
(
because
the
data
generally
are
not
submitted
in
connection
with
a
registration
action),
the
legislative
history
may
indicate
that
Congress
did
intend
to
expand
compensation
and
exclusive
use
rights.
However,
given
the
language
of
section
408(
i),
it
is
unclear
to
EPA
precisely
how
such
rights
would
be
expanded.
If
the
language
"
to
the
same
extent
provided
by
section
3"
truly
incorporates
all
the
provisions
of
section
3,
data
rights
could
not
be
expanded
beyond
current
practice
because
section
3
requires
that
the
data
be
connected
to
a
FIFRA
registration
action.
Thus,
if
Congress
did
intend
to
expand
data
rights
by
enacting
new
408(
i),
it
may
have
intended
the
Agency
to
use
section
3
of
FIFRA
merely
as
a
guidepost
for
developing
protections
for
tolerance
related
data.

III.
Preliminary
Options
for
Implementing
Section
408(
i)

EPA
specifically
solicits
comments
addressing
the
Agency's
implementation
of
the
provisions
of
section
408(
i)
of
FFDCA
that
relate
to
exclusive
use
and
compensation
rights.

Three
preliminary
options
are
presented
for
consideration.
The
options
represent
different
interpretations
of
the
potential
scope
of
the
new
provision
focusing
on
who
the
data
submitters
may
be.
EPA
also
encourages
commenters
to
submit
comments
on
other
interpretations
of
the
new
language
and
suggest
procedures
for
implementing
whatever
option
the
commenter
prefers.
Page
5
of
8
EPA
believes
the
new
section
408(
i)
of
FFDCA
may
provide
the
Agency
with
the
flexibility
to
develop
one
or
more
possible
implementation
schemes.
After
consideration
of
the
comments
received,
the
Office
of
Pesticide
Programs
will
develop
a
proposal
for
implementing
the
data
compensation
and
exclusive
use
provisions
for
data
submitted
to
EPA
under
section
408(
i).

A.
Option
1:
Only
Registrants
and
Applicants
for
Registration
One
approach
to
implementing
section
408(
i)
would
extend
data
compensation
and
exclusive
use
rights
(
data
rights)
only
to
those
persons
who
submit
data
in
support
of
tolerances
or
exemptions
from
tolerances
that
also
meet
all
the
conditions
necessary
to
obtain
such
rights
as
set
forth
in
section
3
of
FIFRA.
This
option
would
read
section
408(
i)
as
Congressional
ratification
of
the
Agency's
current
treatment
of
"
tolerance"
related
data.
Therefore,
under
this
option,
data
rights
under
section
408(
i)
would
only
extend
to
those
persons
who
qualify
as
"
applicants"
under
FIFRA
for
a
current
registration
or
reregistration
action
(
See
section
3(
c)(
1)(
F)
of
FIFRA).

B.
Option
2:
Any
Person
Who
Submits
Data
Related
to
Current
Registration/
reregistration
Action
This
reading
of
section
408(
i),
as
in
option
1,
would
extend
data
rights
to
those
persons
who
submit
data
in
support
of
tolerances
or
exemptions
from
tolerances
that
also
meet
all
the
conditions
necessary
to
obtain
such
rights
as
set
forth
in
section
3
of
FIFRA,
with
the
exception
that
the
submitter
would
not
have
to
be
an
"
applicant
or
registrant"
as
section
3(
c)(
1)(
F)
of
FIFRA
provides.
This
option
would
give
some
meaning
to
the
FQPA
legislative
history
that
Page
6
of
8
indicates
that
Congress
intended
to
offer
protection
to
data
submitted
by
manufacturers
of
other
ingredients.
It
is
unlikely,
however,
that
this
option
would
protect
much
data
submitted
by
manufacturers
of
other
ingredients,
since
such
data
are
rarely
submitted
for
the
specific
purposes
identified
in
FIFRA
section
3
(
registration,
reregistration,
etc.).

C.
Option
3:
Any
Person
Without
Regard
to
Whether
Data
Relate
to
Current
Registration
or
Reregistration
This
reading
of
section
408(
i)
would
extend
data
compensation
and
exclusive
use
rights
to
persons
who
submit
data
and
who
would
otherwise
qualify
for
data
rights
under
both
options
1
and
2
above.
However,
this
option
would
also
extend
rights
to
data
submitters
without
regard
to
whether
the
data
submitted
relates
to
any
current
registration
or
reregistration
action
or
whether
the
data
submitter
is
a
pesticide
registrant.
Protections
would
only
be
linked
to
the
issuance
of
tolerances
and
tolerance
exemptions.
This
approach
would
likely
extend
protection
to
data
submitted
by
manufacturers
of
other
ingredients
and
persons
submitting
data
in
support
of
a
tolerance
or
exemption
to
a
tolerance
for
pesticide
chemical
residues
on
imported
food.
Because
these
individuals
generally
do
not
submit
data
in
connection
with
pesticide
registration
activities
under
FIFRA,
options
1
and
2
above
would
likely
not
provide
the
measure
of
data
protection
provided
by
this
option.

Commenters
should
note
that
because
section
408(
i)
by
its
terms
is
not
limited
to
"
other
ingredients"
data,
any
expansion
of
rights
created
by
408(
i)
may
apply
to
data
on
active
ingredients
in
a
similar
manner.
Further,
it
should
be
noted
that
all
three
options
would
be
implemented
in
connection
with
the
FIFRA
registration/
reregistration
process.
Because
the
FFDCA
does
not
provide
a
licensing
scheme
for
levying
data
requirements
on
all
persons
who
Page
7
of
8
market
products
that
may
benefit
from
the
issuance
of
tolerances
or
tolerance
exemptions,
EPA
believes
Congress
intended
that
the
Agency
use
the
existing
section
3
FIFRA
process
as
a
guidepost
(
e.
g.,
determining
the
period
of
exclusive
use)
for
developing
protections
for
tolerance
related
data.

A
brief
outline
of
these
options
was
presented
to
the
Pesticide
Programs
Dialogue
Committee
(
PPDC)
in
January
1999.
The
PPDC
is
an
advisory
committee
organized
under
the
Federal
Advisory
Committee
Act.
Currently
the
PPDC
is
comprised
of
approximately
27
members
from
the
pesticide
industry,
user,
and
commodity
groups;
Federal
and
State
governments;
consumer
and
environmental/
public
interest
groups,
including
representatives
from
the
general
public;
academia;
and,
public
health
organizations.
The
PPDC
provides
advice
and
guidance
to
the
Office
of
Pesticide
Programs
regarding
pesticide
regulatory,
policy,
and
implementation
issues.
Informally,
several
PPDC
members
expressed
an
interest
in
the
development
and
implementation
of
the
broadest
interpretation
of
the
statutory
language.

IV.
Submitting
Comments
EPA
specifically
solicits
public
comments
on
the
options
described
in
this
paper.
However,

comments
submitted
on
other
interpretations
of
the
new
language
will
also
be
considered.
EPA
asks
commenters
to
also
include
suggested
procedures
for
implementing
whatever
option
the
cementer
prefers.
To
date,
the
Agency
has
already
received
a
position
paper
from
The
Council
For
Advanced
Agricultural
Formulations,
Inc.,
an
association
representing
certain
manufacturers
of
other
ingredients
used
in
pesticide
products,
setting
forth
a
proposed
implementation
scheme
for
this
new
provision
that
is
similar
to
Option
3.

Hard
copies
of
the
options
paper,
or
copies
of
other
public
comments
received
can
be
Page
8
of
8
obtained
by
contacting:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460.
The
PIRIB
is
open
from
8:
30
a.
m.

to
4:
00
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.