Document ID: EPA-HQ-OPP-2003-0229-0001
Agency: epa
Document Type: Notice
Title: Pyridaben; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-03T04:00Z

39942
Federal
Register
/
Vol.
68,
No.
128
/
Thursday,
July
3,
2003
/
Notices
PURPOSE:
EPA
has
the
authority
to
designate
ODMDS
under
Section
102
of
the
Marine
Protection,
Research
and
Sanctuaries
Act
(
MPRSA)
of
1972
(
33USC
1401
et
seq.).
EPA's
preparation
of
this
EIS
is
being
carried
out
pursuant
to
the
October
29,
1998
Notice
of
Policy
and
Procedures
for
Voluntary
Preparation
of
National
Environmental
Policy
Act
(
NEPA)
(
63
FR
58045).
Public
comments
on
the
scope
of
the
EIS
evaluation
will
be
accepted
for
45
days
from
the
date
of
this
notice.
FOR
FURTHER
INFORMATION,
TO
SUBMIT
COMMENTS,
AND
TO
BE
PLACED
ON
A
PROJECT
MAILING
LIST,
CONTACT:
Mr.
Allan
Ota,
U.
S.
Environmental
Protection
Agency,
Region
9,
Dredging
and
Sediment
Management
Team
(
WTR
 
8),
75
Hawthorne
Street,
San
Francisco,
California
94105
 
3901,
Telephone:
(
415)
972
 
3476
or
FAX:
(
415)
947
 
3537
or
E­
mail:
R9_
LA3LA2disposal
sites_
scoping@
epa.
gov.
SUMMARY:
EPA
intends
to
conduct
public
meetings
and
collect
public
comments
in
advance
of
preparing
an
EIS
to
designate
LA
 
3
as
a
permanent
ODMDS
off
Newport
Bay,
California.
The
EIS
will
also
re­
evaluate
an
annual
disposal
volume
limit
for
the
existing
LA
 
2
ODMDS,
and
how
to
minimize
cumulative
environmental
impacts
from
two
ODMDS
in
the
region.
NEED
FOR
ACTION:
Dredging
is
essential
for
maintaining
safe
navigation
in
harbors
and
marinas
in
the
Los
Angeles
County
and
Orange
County
region.
Not
all
dredged
materials
are
suitable
for
beneficial
re­
use
(
e.
g.,
construction,
wetlands
restoration),
and
it
is
not
feasible
to
use
the
existing
LA
 
2
ODMDS
for
all
projects
in
the
region.
The
LA
 
3
ODMDS
has
been
used
by
some
Orange
County
projects
in
the
past,
but
its
``
interim''
status
has
expired.
Therefore
there
is
a
need
to
designate
LA
 
3
as
a
permanent
ODMDS.
ALTERNATIVES:
The
following
proposed
alternatives
have
been
tentatively
defined.
 
`
`
No
Action''
 
Do
not
designate
LA
 
3
as
a
permanent
ODMDS,
and
continue
to
manage
the
existing
LA
 
2
ODMDS
without
a
designated
maximum
annual
disposal
volume
limit.
 
`
`
Maximize
Use
of
LA
 
2''
 
Do
not
designate
LA
 
3
as
a
permanent
ODMDS,
but
establish
a
maximum
annual
disposal
volume
limit
for
the
LA
 
2
site
adequate
to
meet
the
ocean
disposal
needs
of
all
Los
Angeles­
Orange
County
region
projects.
 
`
`
Local
Use
of
LA
 
3
and
LA
 
2''
 
Designate
LA
 
3
as
a
permanent
ODMDS
primarily
for
Orange
County
projects,
and
establish
a
higher
maximum
annual
disposal
volume
limit
for
LA
 
2
to
accommodate
most
Los
Angeles
area
projects.
 
`
`
Maximize
Use
of
LA
 
3''
 
Designate
LA
 
3
as
a
permanent
ODMDS
with
a
maximum
annual
disposal
limit
to
meet
the
ocean
disposal
needs
of
all
Los
Angeles­
Orange
County
region
projects
to
the
extent
feasible,
and
establish
an
annual
disposal
volume
limit
for
LA
 
2
to
accommodate
only
those
projects
that
could
not
feasibly
use
LA
 
3.
SCOPING:
EPA
is
requesting
written
comments
from
federal,
state,
and
local
governments,
industry,
nongovernmental
organizations,
and
the
general
public
on
the
need
for
action,
the
range
of
alternatives
considered,
and
the
potential
impacts
of
the
alternatives.
Scoping
comments
will
be
accepted
for
45
days,
beginning
with
the
date
of
this
Notice.
Public
scoping
meetings
are
scheduled
at
two
locations
on
the
following
dates:
1.
July
21,
2003,
2
 
4
p.
m.
and
7
 
9
p.
m.,
in
Orange
County
at
the
Upper
Newport
Bay
Peter
and
Mary
Muth
Interpretive
Center,
2301
University
Drive,
Newport
Beach,
California
92660
(
corner
of
University
Drive
and
Irvine
Avenue).
2.
July
22,
2003,
2
 
4
p.
m.
and
7
 
9
p.
m.,
in
Los
Angeles
County
at
the
Port
of
Long
Beach,
925
Harbor
Plaza,
Long
Beach,
California
90802,
on
the
5th
Floor
Conference
Room.
Estimated
Date
of
Draft
EIS
Release:
February
2004.

Dated:
June
30,
2003.
Anne
Norton
Miller,
Director,
Office
of
Federal
Activities.
[
FR
Doc.
03
 
16846
Filed
7
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0229;
FRL
 
7315
 
4]

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

SUMMARY:
This
notice
announces
the
initial
filing
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
ID
number
OPP
 
2003
 
0229,
must
be
received
on
or
before
August
4,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturer
(
NAICS
311)
 
Pesticide
manufacturer
(
NAICS
32532)
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
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
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
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0229.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
VerDate
Jan<
31>
2003
18:
18
Jul
02,
2003
Jkt
200001
PO
00000
Frm
00049
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
03JYN1.
SGM
03JYN1
39943
Federal
Register
/
Vol.
68,
No.
128
/
Thursday,
July
3,
2003
/
Notices
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0229.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2003
 
0229.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2003
 
0229.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2003
 
0229.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
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CD
ROM
the
specific
information
that
is
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
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
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
ID
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
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
theelements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
June
26,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner
summary
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
were
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
4
(
IR­
4)

0E6068,
1E6226,
1E6303,
2E6457,
and
2E6460
EPA
has
received
pesticide
petitions
(
0E6068,
1E6226,
1E6303,
2E6457,
and
2E6460)
from
IR­
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.494
by
establishing
tolerances
for
combined
residues
of
pyridaben,
2­
tert­
butyl­
5­(
4­
tert­
butylbenzylthio)­
4­
chloropyridazin­
3(
2H)­
one
in
or
on
the
following
raw
agricultural
commodities:
strawberry
at
2.5
parts
per
million
(
ppm)(
PP
0E6068);
hop,
dried
cones
at
10.0
ppm
(
PP
1E6226);
tomato
at
0.2
ppm
(
PP
1E6303);
fruit,
stone,
group
at
2.5
ppm
(
PP
2E6457),
papaya,
black
sapote,
canistel,
mamey
sapote,
mango,
sapodilla,
and
star
apple
at
0.1
ppm
(
PP
2E6460).
Registration
for
tomato
will
be
limited
to
greenhouse
grown
tomato
based
on
the
available
residue
data.
The
petitioner
also
proposes
that
established
tolerances
for
nectarine,
peach,
plum,
and
prune
at
2.5
ppm
be
deleted
since
they
will
be
superceded
by
the
tolerance
for
fruit,
stone,
group
at
2.5
ppm.
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
This
summary
has
been
prepared
by
the
BASF
Corporation.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
the
residue
in
plants
is
adequately
understood.
The
residue
of
concern
is
pyridaben
per
se
as
specified
in
40
CFR
180.494.
2.
Analytical
method.
The
proposed
analytical
method
involves
extraction,
partition,
clean­
up
and
detection
of
residues
by
gas
chromatography/
electron
capture
detector
(
gc/
ecd).
3.
Magnitude
of
residues.
Field
trials
were
carried
out
in
order
to
determine
the
magnitude
of
the
residue
in
the
following
crops:
Strawberries,
hops,
cherries
(
to
satisfy
the
requirements
for
a
stone
fruits
group),
and
papaya.
Two
greenhouse
tomato
residue
trials
were
conducted
in
Canada.
Residue
trials
were
carried
out
using
the
maximum
label
rate,
the
maximum
number
of
applications,
and
the
minimum
preharvest
interval
for
each
crop
or
crop
group.

B.
Toxicological
Profile
1.
Acute.
In
general,
the
acute
toxicology
studies
conducted
on
technical
grade
pyridaben
demonstrate
that
it
has
moderate
to
mild
toxic
effects.
It
was
classified
as
Toxicity
Category
III
based
upon
the
acute
oral
lethal
dose
(
LD)
50
of
1,100
mg/
kg
in
male
rats
and
570
mg/
kg
in
female
rats.
The
dermal
LD50
in
rabbits
was
greater
than
or
equal
to
2,000
mg/
kg
(
Tox.
Cat.
III)
and
the
inhalation
lethal
concentrations
(
LC)
50
were
0.66
and
0.64
mg/
kg
in
male
and
female
rats,
respectively
(
Tox
Cat.
III).
The
eye
irritation
study
(
rabbits)
produced
slight
ocular
irritation
(
Tox.
Cat.
III).
Pyridaben
was
not
a
dermal
irritant
(
Tox.
Cat.
IV)
or
sensitizer.
2.
Genotoxicity.
Genotoxicity
studies
including
Ames
testing,
in
vitro
cytogenicity
(
chinese
hamster
lung
cell),
in
vivo
micronucleus
assay
(
mouse)
and
DNA
damage/
repair
(
E.
coli)
showed
no
genotoxic
activity
associated
with
pyridaben.
3.
Reproductive
and
developmental
toxicity.
In
a
developmental
toxicity
study,
Sprague­
Dawley
rats
(
22/
group)
from
Charles
River,
U.
K.,
received
Pyridaben
(
98.0%
pure)
via
gavage
at
dose
levels
of
0,
2.5,
5.7,
13.0,
or
30.0
milligram
kilogram
day
(
mg/
kg/
day)
from
gestation
day
6
through
15,
inclusive.
Maternal
toxicity,
observed
at
13.0
and
30.0
mg/
kg/
day,
consisted
of
decreased
body
weight/
weight
gain
and
food
consumption
during
the
dosing
period.
Based
on
these
effects,
the
maternal
toxicity
lowest
observed
adverse
effect
level
(
LOAEL)
is
13.0
mg/

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kg/
day
and
the
maternal
toxicity
no
observed
adverse
effect
level
(
NOAEL)
is
4.7
mg/
kg/
day
(
82%
of
5.7
mg/
kg/
day
based
on
concentration
analysis).
The
developmental
toxicity
NOAEL
is
13.0
mg/
kg/
day
based
on
observed
decreased
fetal
body
weight
and
increased
incomplete
ossification
in
selected
bones
at
30.0
mg/
kg/
day
LOAEL.
New
Zealand
white
rabbits
(
19
or
20/
group)
were
orally
dosed
with
0,
1.5,
5,
or
15
mg/
kg/
day
pyridaben
from
day
6
through
19
of
gestation.
Maternal
toxicity
was
evidenced
by
a
dosedependent
decrease
in
body
weight
gain
and
food
consumption
at
all
dose
levels.
There
was
also
increased
incidences
of
abortions
and
clinical
signs
(
few
feces)
in
the
15
mg/
kg/
day
group.
There
was
no
evidence
that
the
chemical
had
a
developmental
effect
at
any
of
the
tested
levels.
The
maternal
NOAEL
was
<
1.5
mg/
kg/
day
and
the
Maternal
LOAEL
was
1.5
mg/
kg/
day
based
on
decreases
in
body
weight
gain
and
food
consumption
at
all
dose
levels.
No
developmental
toxicity
was
observed
at
any
dose
level.
Therefore,
the
NOAEL
for
developmental
toxicity
is
greater
than
or
equal
to
15
mg/
kg/
day.
In
a
standard
two­
generation
reproduction
study,
CD
rats
were
administered
pyridaben
in
the
diet
at
doses
of
0,
10,
28
or
80
ppm.
The
Parental/
Systemic
NOAEL
is
28
ppm
(
2.20
and
2.41
mg/
kg/
day
for
males
and
females,
respectively).
The
parental/
systemic
LOAEL
is
80
ppm
(
6.31
and
7.82
mg/
kg/
day
for
males
and
females,
respectively)
based
on
decreased
body
weights,
body
weight
gains
and
food
efficiency.
There
was
no
effect
on
reproductive
parameters
on
the
dose
levels
tested.
The
reproductive
NOAEL
is
 
80
ppm
in
males
and
females.
The
reproductive
LOAEL
is
>
80
ppm
in
males
and
females.
4.
Subchronic
toxicity.
In
a
21
 
day
dermal
study,
rats
received
repeated
topical
applications
of
pyridaben
(
98%
pure)
to
about
10%
of
the
body
surface
area
at
dosages
of
30,
100,
300
and
1,000
mg/
kg
for
21
days.
The
treatment
produced
body
weight
decreases
in
the
300
mg/
kg/
day
females
and
in
the
1,000
mg/
kg/
day
males
and
females.
The
NOAEL
was
100
mg/
kg/
day
and
the
LOAEL
was
300
mg/
kg/
day
based
on
decreased
body
weight
gain
in
females.
The
toxicology
endpoints
from
this
study
were
selected
by
the
Agency
for
short­
and
intermediate­
term
dermal
risk
assessments.
5.
Chronic
toxicity.
In
a
12
 
month
chronic
feeding
study
in
dogs
pyridaben
was
administered
in
capsules
at
dosages
of
0,
1.0,
4.0,
16.0
or
32.0
mg/
kg/
day.
All
animals
survived
until
the
end
of
the
study
and
there
were
no
treatmentrelated
changes
in
hematology,
clinical
chemistry,
or
urinalysis
parameters.
The
NOAEL
was
determined
to
be
<
1.0
mg/
kg/
day
and
the
LOAEL
was
 
1.0
mg/
kg/
day
based
on
increased
incidences
of
clinical
signs
(
thinness,
dehydration,
diarrhea,
emesis,
soft
stool,
ptyalism,
and
relaxed
nictitans)
in
treatment
groups
of
both
sexes
and
decreased
body
weight
gain
in
females
at
1.0
mg/
kg/
day.
In
a
follow­
up
study,
Pyridaben
was
administered
in
capsules
to
beagle
dogs
at
dosages
of
0
and
0.5
mg/
kg/
day
for
1
year.
The
NOAEL
was
determined
to
be
<
0.5
mg/
kg/
day
for
males
and
females
and
the
LOAEL
was
 
0.5
mg/
kg/
day
for
males
and
females
based
on
an
increased
incidence
of
clinical
signs
in
both
treated
sexes
and
decreased
weight
gain
in
the
treated
females.
Pyridaben
was
administered
in
the
diet
to
CD­
1
mice
at
dosages
of
0,
2.5,
8.0,
25
or
80
ppm
for
78
weeks.
There
was
no
evidence
of
a
carcinogenic
effect
of
the
chemical.
The
NOAEL
was
determined
to
be
25
ppm
(
2.78
mg/
kg/
day)
for
males
and
females
and
a
LOAEL
of
80
ppm
(
8.88
and
9.74
mg/
kg/
day
for
males
and
females,
respectively).
The
LOAEL
was
determined
to
be
80
ppm
for
males
and
females
based
on
decreased
body
weight
gain,
decreased
food
efficiency
and
changes
in
organ
weights
and
histopathology
(
males).
Pyridaben
was
administered
in
the
diet
to
groups
of
Wistar
rats
for
104
weeks
at
doses
of
0,
4,
10,
28
or
80
ppm
to
assess
carcinogenicity.
Additional
groups
(
35
animals/
sex/
dose)
received
doses
of
0,
4,
10,
28
or
120
ppm
for
104
weeks
(
with
an
interim
sacrifice
at
53
weeks)
to
assess
chronic
toxicity.
There
was
no
treatment­
related
neoplastic
or
non­
neoplastic
pathology
in
either
phase
of
the
study.
The
NOAEL
was
determined
to
be
28
ppm
in
males
(
1.13
mg/
kg/
day)
and
28
ppm
(
1.46
mg/
kg/
day)
in
females.
The
LOAEL
was
determined
to
be
120
ppm
(
5.00
mg/
kg/
day)
in
males
and
120
ppm
(
6.52
mg/
kg/
day)
in
females
based
on
decreased
body
weight
gain
in
males
and
females
and
decreased
ALT
levels
in
males
in
the
chronic
toxicity
phase.
There
was
no
evidence
of
a
carcinogenic
effect
of
this
chemical.
6.
Animal
metabolism.
In
an
acceptable
rat
metabolism
study
by
the
oral
route,
pyridaben
was
mainly
eliminated
in
the
feces
where
80
 
97%
of
the
administered
dose
was
excreted
regardless
of
the
dose
or
site
of
label
(
pyridazinone
or
benzyl
ring).
Nearly
20%
of
the
excreted
residue
in
the
feces
was
unmetabolized
parent
compound
and
there
was
some
evidence
of
glucoronide
conjugate(
s)
in
the
bile.
The
plasma
levels
following
a
single
low
oral
dose
(
3
mg/
kg)
peaked
at
23
hours
while
peak
levels
at
the
high
dose
(
30
mg/
kg)
were
at
approximately
24
hours
post­
dose
due,
at
least
in
part,
to
enterhepatic
circulation
(
nearly
22
 
30%
of
an
administered
radioactive
dose
is
excreted
in
bile
within
a
period
of
24
hours).
Residual
radioactivity
was
at
or
near
background
levels
for
most
tissues
by
72
to
168
hours.
Generally,
there
seemed
to
be
increased
distribution
to
fat
over
time
and,
compared
to
other
tissues,
fat
seemed
to
have
relatively
more
residual
radioactivity.
Several
metabolites,
totaling
up
to
20
 
30,
were
resolved
in
urine
and
feces
and
some
were
structurally
identified.
7.
Metabolite
toxicology.
The
nature
of
the
residue
in
animals
is
adequately
understood.
The
residue
of
concern
is
pyridaben
and
its
metabolites
PB
 
7,
2­
tert­
butyl­
5­[
4­(
1­
carboxy­
1­
methylethyl)
benzylthio]­
4­
chloropyridazin­
3(
2H)­
one
and
PB
 
9,
2­
tert­
butyl­
4­
chloro­
5­[
4­(
1,1­
dimethyl­
2­
hydroxyethyl)
benzylthio]­
chloropyridazin­
3(
2H)­
one
as
specified
in
40
CFR
180.494.
8.
Endocrine
disruption.
The
most
common
toxicity
endpoint
across
the
various
studies
and
test
species
was
decreased
body
weight/
decreased
body
weight
gain
followed
by
decreased
feed
consumption
and/
or
feed
efficiency.
These
effects
were
observed
in
the
13
 
week
feeding
study
in
mice,
in
a
13
 
week
rat
study,
in
two
13
 
week
dog
studies,
in
a
21
 
day
rat
dermal
study,
in
a
28
 
day
inhalation
toxicity
study
in
rats,
in
two
1
 
year
feeding
studies
in
dogs,
in
a
78
 
week
feeding/
carcinogenicity
study
in
mice,
in
a
developmental
toxicity
study
in
rats,
in
two
developmental
studies
in
rabbits,
and
in
a
2
 
year
feeding
carcinogenicity
study
in
rats.
The
LOAELs
were
always
based
on
decreases
in
body
weight
gain/
body
weight
decreases
or
decreases
in
food
consumption.
Other
effects
were
sporadic
and
involved
changes
in
certain
clinical
chemistry
values
or
increases
or
decreases
in
organ
weights.
Thus,
there
is
no
indication
that
effects
on
the
endocrine
system
were
responsible
for
any
of
the
observed
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Assessments
were
conducted
to
evaluate
the
potential
risk
due
to
chronic
and
acute
dietary
exposure
of
the
U.
S.
population
to
residues
of
pyridaben
(
BAS
300
I).
Commodities
(
crops
and
animal
products)
specified
in
40
CFR
180.494
and
all
new/
updated
crop
tolerances
were
included
in
the
dietary
assessment
(
citrus,
pome
fruit,
stone
fruit,
grapes,

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cranberries,
tree
nuts,
pistachio,
papaya
and
similar
fruit,
strawberries,
hops,
green
house
tomatoes,
and
secondary
residues
in
animal
products
meat,
meat
byproducts,
fat
­
from
cattle,
goat,
hog,
horse,
sheep).
i.
Food.
Specific
inputs
and
default
values
were
considered
in
the
pyridaben
dietary
assessment.
Anticipated
residue
values
from
the
raw
agricultural
commodities
and
the
residue
tolerances
utilized
in
the
assessment
were
multiplied
by
a
factor
of
2.3
to
include
all
organosoluble
residues
of
pyridaben.
Tolerance
values
were
assumed
for
pistachios,
tree
nuts,
and
secondary
residues
in
meat,
meat
byproducts,
fat,
and
milk.
The
2.3
multiplication
factor
was
not
used
for
these
animal
commodities
since
the
residues
of
concern
(
pyridaben
and
its
metabolites),
as
specified
in
40
CFR
180.494
are
well
understood
in
animals.
Default
processing
factors
were
used
for
all
commodities
except
for
those
specified
in
Table
1
below.
In
addition,
percent
crop
treated
(%
CT)
values
of
23,
5.8,
and
11.4%
were
utilized
for
pome
fruit,
grapes,
and
citrus,
respectively.
These
percent
crop
treated
values
were
based
on
the
2000
to
2002
pyridaben
peak
sales
year
and
peak
acreage
year.
All
other
crops
were
considered
to
have
100%
crop
treated.
TABLE
1.
 
PROCESS
FACTORS
USED
IN
THE
PYRIDABEN
DIETARY
ASSESSMENT
Commodity
Process
Process
Factor
Citrus
washed
juice
0.48
0.096
Apples/
Pears
washed
juice
0.68
0.09
Grapes
juice
dried
0.04
0.94
*
Default
processing
factors
were
used
for
all
other
commodities.

ii.
Drinking
water.
There
are
no
established
maximum
contaminant
levels
or
health
advisory
levels
for
residues
of
pyridaben
(
BAS
300
I)
or
its
metabolites
in
drinking
water.
The
PRZM/
EXAMS
and
SciGrow
models
were
used
to
estimate
the
maximum
concentrations
in
surface
and
ground
water,
respectively.
Pyridaben
is
immobile
and
thus
unlikely
to
leach
to
groundwater.
Results
of
environmental
modeling
indicate
an
estimated
0.215
ppm
(
acute)
and
0.020
ppm
(
chronic)
of
pyridaben
in
surface
water.
2.
Non­
dietary
exposure.
Pyridaben
(
BAS
300
I)
is
a
plant
protection
product
used
to
control
insects.
This
product
is
not
considered
for
residential
use
and
therefore
the
aggregate
exposure
is
a
result
of
pyridaben
residues
in
food
and
water.

D.
Cumulative
Effects
The
cumulative
exposure
to
substances
with
common
mechanism
of
toxicity
must
be
considered.
Currently
at
this
time
there
is
not
available
data
to
determine
whether
pyridaben
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
pyridaben
does
not
appear
to
form
a
toxic
metabolite
produced
by
other
substances.
As
a
result,
for
the
purposes
of
this
tolerance
action,
it
is
assumed
that
pyridaben
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
1.
Acute.
Exposure
estimates
for
the
pyridaben
acute
dietary
assessment
were
well
under
100%
of
the
aPAD
at
the
99.9th
percentile.
The
overall
general
population
and
the
most
sensitive
subpopulation
(
females
13
 
49
years)
utilized
<
11%
and
14.5%
of
the
acute
population
adjusted
dose
(
aPAD),
respectively.
Results
from
a
Tier
I
dietary
assessment
of
pyridaben
residues
in
cranberries
indicates
the
percent
aPAD
for
children
1
 
6
years
old
and
females
13
 
49
years
old
were
<
3%.
Therefore
considering
all
current
and
pending
commodities,
including
cranberries,
the
percent
chronic
reference
dose
(%
cRfD)
and
percent
chronic
population
dose
(%
cPAD)
will
be
below
20%
for
all
population
subgroups.
Further
refinements
including
additional
percent
crop
treated,
processing
factors,
cooking
factors,
actual
residue
values
for
the
remaining
commodities
(
where
default
values
and
tolerance
levels
were
used
for
this
assessment)
would
further
reduce
the
exposure
estimates.

TABLE
2.
ACUTE
DIETARY
EXPOSURE
ASSESSMENT
FOR
FOR
PYRIDABEN
(
BAS
300
I)

Population
Subgroups
Exposure
Estimate
(
mg/
kg
b.
w.
/
day)
%
aRfD
%
aPAD
Birth
to
1
year
0.04488
8.98
8.98
1
 
2
years
0.0509
10.18
10.18
3
 
5
years
0.04339
8.68
8.68
1
 
6
years
0.03382
6.76
6.76
6
 
12
years
0.0300
6.00
6.00
13
 
19
years
0.01327
2.65
2.65
Females
13
 
49
years
0.01885
14.50
14.50
Males
20
 
49
years
0.01101
2.20
2.20
Adults
50+
years
0.01591
3.18
3.18
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Vol.
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/
Thursday,
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3,
2003
/
Notices
2.
Chronic.
The
estimated
chronic
dietary
exposure
for
all
current
and
pending
commodities
(
except
cranberries)
ranged
from
15.6
to
77.3%
for
the
cRfD
and
cPAD
for
all
subpopulations.
Results
from
a
Tier
I
dietary
assessment
of
pyridaben
residues
in
cranberries
indicates
the
percent
cPAD
for
children
1
 
6
years
old
and
females
of
childbearing
years
(
13
 
49
years
old)
were
7.1%
and
12.9%,
respectively.
Therefore
considering
all
current
and
pending
commodities,
including
cranberries,
the
%
cRfD
and
%
cPAD
will
be
below
100%
for
all
population
subgroups.
Further
refinements
including
additional
percent
crop
treated,
processing
factors,
cooking
factors,
actual
residue
values
for
the
remaining
commodities
(
that
used
default
values
and
tolerance
levels)
would
further
reduce
the
exposure
estimates.

TABLE
3.
 
CHRONIC
DIETARY
EXPOSURE
ASSESSMENT
FOR
PYRIDABEN
(
BAS
300
I)

Population
Subgroups
Exposure
Estimate
mg/
kg
b.
w./
day)
%
cRfD
%
Cpad
Birth
to
1
year
0.00371
74.2
74.2
12
years
0.003867
77.34
77.34
35
years
0.002752
55.04
55.04
16
years
0.0031
62
62
6
 
12
years
0.002541
50.82
50.82
13
 
19
years
0.0009618
19.236
19.236
The
aggregate
exposure
(
food
and
drinking
water)
of
pyridaben
will
not
exceed
the
U.
S.
EPA's
level
of
concern
(
100%
of
RfD).
Overall,
we
can
conclude
with
reasonable
certainty
that
no
harm
will
occur
from
either
acute
or
chronic
aggregate
exposure
of
pyridaben
residues
as
a
result
of
use
on
citrus,
pome
fruit,
stone
fruit,
grapes,
cranberries,
tree
nuts,
pistachio,
papaya
(
and
similar
fruit),
strawberries,
hops,
and
green
house
tomatoes.

F.
International
Tolerances
Maximum
residue
levels
(
MRLs)
have
been
established
for
pyridaben
in
Canada.
No
MRLs
have
been
established
by
the
Codex
Alimentarius
Commission.
[
FR
Doc.
03
 
16930
Filed
7
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
ELECTION
COMMISSION
Sunshine
Act
Meeting
Special
Executive
Session
DATE
AND
TIME:
Thursday,
July
3,
2003
at
10
a.
m.
PLACE:
999
E
Street,
NW.,
Washington,
DC.
STATUS:
This
meeting
was
closed
to
the
public
pursuant
to
11
CFR
2.4(
b)(
1).

DATE
AND
TIME:
Tuesday,
July
8,
2003
at
10
a.
m.
PLACE:
999
E
Street,
NW.,
Washington,
DC.
STATUS:
This
meeting
will
be
closed
to
the
public.

ITEMS
TO
BE
DISCUSSED:
Compliance
matters
pursuant
to
2
U.
S.
C.
437g.
Audits
conducted
pursuant
to
2
U.
S.
C.
437g,
438(
b),
and
Title
26,
U.
S.
C.
Matters
concerning
participation
in
civil
actions
or
proceedings
or
arbitration.
Internal
personnel
rules
and
procedures
or
matters
affecting
a
particular.

DATE
AND
TIME:
Thursday,
July
10,
2003
at
10
a.
m.

PLACE:
999
E
Street,
NW.,
Washington,
DC
(
ninth
floor).

STATUS:
This
meeting
will
be
open
to
the
public.

ITEMS
TO
BE
DISCUSSED:

Correction
and
Approval
of
Minutes.
Draft
Advisory
Opinion
2003
 
12:
Stop
Taxpayer
Money
for
Politicians
Committee
(``
STMP'')
and
Representative
Jeff
Flake
of
Arizona
by
counsel,
Benjamin
L.
Ginsberg.
Draft
Advisory
Opinion
2003
 
17:
James
W.
Treffinger
and
Treffinger
for
Senate
Committee
by
counsel,
Karin
Riecker.
Routine
Administrative
Matters.

PERSON
TO
CONTACT
FOR
INFORMATION:
Mr.
Ron
Harris,
Press
Officer,
Telephone:
(
202)
694
 
1220.

Mary
W.
Dove,

Secretary
of
the
Commission.
[
FR
Doc.
03
 
17026
Filed
7
 
1
 
03;
10:
46
am]

BILLING
CODE
6715
 
01
 
M
FEDERAL
HOUSING
FINANCE
BOARD
[
No.
2003
 
N
 
05]

Privacy
Act
of
1974;
System
of
Records
AGENCY:
Federal
Housing
Finance
Board.
ACTION:
Notice
with
request
for
comments.

SUMMARY:
In
accordance
with
the
Privacy
Act
of
1974
(
Privacy
Act),
the
Federal
Housing
Finance
Board
(
Finance
Board)
is
providing
notice
of
its
intent
to
amend
its
system
of
records
to
reflect
agency
reorganizations
and
regulatory
changes
and
to
add
a
new
system
of
records
covering
Office
of
Inspector
General
investigative
files.
Elsewhere
in
this
issue
of
the
Federal
Register,
the
Finance
Board
is
publishing
an
interim
final
rule
with
request
for
comments
that
revises
the
agency's
Privacy
Act
regulation
to
reflect
an
agency
reorganization
in
which
responsibility
and
authority
for
running
the
agency's
Privacy
Act
program
was
transferred
to
the
Office
of
General
Counsel.
The
Finance
Board
also
is
revising
the
rule
to
make
it
more
``
user­
friendly''
by
using
plain
language
and,
where
appropriate,
a
question­
andanswer
format.
DATES:
This
amendment
will
become
effective
as
proposed
without
further
notice
on
August
4,
2003
unless
comments
dictate
otherwise.
The
Finance
Board
will
accept
comments
in
writing
on
or
before
August
4,
2003.
ADDRESSES:
Send
comments
by
electronic
mail
to
comments@
fhfb.
gov,

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