Document ID: EPA-HQ-OPP-2002-0296-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-01-29T05:00Z

19755
Federal
Register
/
Vol.
65,
No.
71
/
Wednesday,
April
12,
2000
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
00621A;
FRL
 
6552
 
1]

Pesticides;
Data
Submitter
Rights
for
Data
Submitted
in
Support
of
Tolerance
Actions;
Notice
of
Availability;
Reopening
of
Comment
Period
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
On
January
19,
2000
(
65
FR
2947)
(
FRL
 
6385
 
7),
EPA
announced
the
availability
for
comment
of
a
paper
discussing
options
to
enable
the
Agency
to
appropriately
implement
the
new
provisions
contained
in
section
408(
i)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
to
address
exclusive
use
and
compensation
rights
for
data
submitted
to
EPA
in
support
of
tolerance
and
tolerance
exemption
actions.
The
comment
period
closed
on
March
20,
2000.
However,
the
Agency
received
requests
to
extend
the
comment
period.
This
notice
announces
the
reopening
of
the
comment
period
for
an
additional
30
days.
DATES:
Comments,
identified
by
docket
control
number
OPP
 
00621A
must
be
received
on
or
before
May
12,
2000.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP
 
00621A
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
Cameo
G.
Smoot,
Field
and
External
Affairs
Division
(
7506C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
Ariel
Rios
Bldg.,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
5454;
fax
number:
(
703)
305
 
5884;
e­
mail
address:
smoot.
cameo@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
you
if
you
submit
data
to
EPA
in
support
of
establishing
or
maintaining
tolerances
for
pesticides,
or
are
a
pesticide
registrant
or
a
person
applying
for
pesticide
registration
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
You
may
also
be
interested
in
commenting
if
you
submit
data
to
EPA
in
support
of
an
exemption
from
a
tolerance.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
 
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
may
obtain
a
copy
of
the
options
paper
described
in
this
notice
by
accessing
this
Federal
Register
notice
using
the
Federal
Register
Environmental
Documents
cite
on
EPA's
Internet
and
selecting
``
Related
Documents.''
Hard
copies
of
the
options
paper
are
available
by
consulting
with
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP
 
00621A.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.
C.
How
and
to
Whom
Do
I
Submit
Comments?

You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP
 
00621A
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Ariel
Rios
Bldg.,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e­
mail
to:
``
opp­
docket@
epa.
gov,''
or
you
can
submit
a
computer
disk
as
described
in
this
unit.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
control
number
OPP
 
00621A.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?

Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
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19756
Federal
Register
/
Vol.
65,
No.
71
/
Wednesday,
April
12,
2000
/
Notices
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
identified
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
is
reopening
the
comment
period
for
an
additional
30
days
and
will
continue
to
make
available
for
comment
an
options
paper
on
exclusive
use
and
data
compensation
rights
for
data
submitted
to
the
Agency
in
support
of
tolerance
and
tolerance
exemption
actions.
As
part
of
the
Food
Quality
Protection
Act
of
1996,
Congress
amended
section
408(
i)
of
the
FFDCA
addressing
such
rights.
The
Agency
is
currently
evaluating
how
to
implement
this
new
provision
and
is
seeking
public
comment.
The
options
paper
briefly
discusses
the
new
section
408(
i)
of
the
FFDCA
and
the
Agency's
practices
regarding
data
compensation
and
exclusive
use;
the
current
compensation
and
exclusive
use
process
the
Agency
implements
under
section
3
of
FIFRA;
and
presents
three
options
for
implementing
the
new
provision.
The
options
represent
different
interpretations
focusing
on
who
the
data
submitters
may
be.
However,
the
Agency
also
seeks
comments
on
other
interpretations
of
section
408(
i)
and
suggested
procedures
for
implementing
whatever
option
the
commenter
prefers.
EPA
will
consider
the
comments
received
and
develop
a
detailed
proposal
for
implementing
data
rights
under
section
408(
i)
of
FFDCA.
List
of
Subjects
Environmental
protection,
Pesticide
tolerances,
Data
compensation.

Dated:
April
4,
2000.
Marcia
E.
Mulkey,
Director,
Office
of
Pesticide
Programs.
[
FR
Doc.
00
 
9097
Filed
4
 
11
 
00;
8:
45
am]

BILLING
CODE
6560
 
50
 
F
ENVIRONMENTAL
PROTECTION
AGENCY
[
PF
 
934;
FRL
 
6551
 
8]

Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
Certain
Pesticide
Chemicals
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
amendment
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments
identified
by
docket
control
number
PF
 
934,
must
be
received
on
or
before
May
12,
2000.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
``
SUPPLEMENTARY
INFORMATION.''
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
PF
 
934
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Mary
Waller,
fungicide
Branch,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
Ariel
Rios
Bldg.,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308
 
9354;
e­
mail
address:
waller.
mary@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
Categories
NAICS
codes
Examples
of
potentially
affected
entities
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register­­
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
PF
 
934.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,

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2000
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