Document ID: EPA-HQ-OPP-2003-0223-0001
Agency: epa
Document Type: Notice
Title: 6-Benzyladenine; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-30T04:00Z

44777
Federal
Register
/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0223;
FRL
 
7315
 
7]

6­
Benzyladenine;
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
identification
(
ID)
number
OPP
 
2003
 
0223,
must
be
received
on
or
before
August
29,
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:
Denise
Greenway,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8263;
e­
mail
address:
greenway.
denise@
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
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
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
ID
number
OPP
 
2003
 
0223.
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
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
EPA's
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.
1.
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
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/
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68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
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
 
0223.
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
 
0223.
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
 
0223.
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
 
0223.
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
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
the
elements
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:
July
16,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
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.

I.
Valent
BioSciences
Corporation
PP
3F6586
EPA
has
received
a
pesticide
petition
(
PP
3F6586)
from
Valent
BioSciences
Corporation,
870
Technology
Way,
Suite
100,
Libertyville,
IL.
60048,
proposing
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
biochemical
pesticide
6­
benzyladenine
(
6­
BA)
in
or
on
pistachio,
and
to
amend
the
existing
exemption
(
§
180.1150)
for
apples
to
expand
the
uses
and
increase
the
application
rate.
Valent
BioSciences
Corporation
has
submitted
the
following
summary
of
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/
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68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Valent
BioSciences
Corporation
and
EPA
has
not
fully
evaluated
the
merits
of
the
pesticide
petition.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.

A.
Product
Name
and
Proposed
Use
Practices
6­
Benzyladenine
is
a
naturally
occurring
plant
growth
regulator
used
on
certain
fruit
trees
and
certain
ornamental
lily
tubers.
In
January
1990,
the
Agency
classified
6­
BA
as
a
biochemical
pesticide
because
it
resembles
natural
plant
regulators
and
it
displays
a
nontoxic
mode
of
action.
The
new
use
being
proposed
for
6­
BA
is
as
an
effective
stand­
alone
fruitlet
thinner
when
applied
to
apples
in
the
postbloom
period
at
an
application
rate
not
to
exceed
182
grams
of
active
ingredient
per
acre
per
season
(
gram
per
active
ingredient
per
acre
per
season).
6­
Benzyladenine
has
also
been
shown
to
directly
increase
cell
division
of
treated
fruit,
resulting
in
improvements
in
fruit
size
over
what
would
be
expected
from
the
normal
thinning
effect.
The
frequency
and
timing
of
application
will
vary
according
to
the
specific
growing
conditions
being
treated.
The
second
proposed
new
use
is
to
reduce
alternate
bearing
in
pistachio
and
thus
increase
cumulative
yield.
The
proposed
maximum
application
rate
for
pistachio
is
60
grams
of
active
ingredient
per
acre
per
season.

B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
6­
Benzyladenine
(
N­(
phenylmethyl)­
1Hpurin
6­
amine)
has
been
tested
and
residue
data
generated
has
been
provided
to
EPA
by
Valent
BioSciences
Corporation.
2.
Magnitude
of
residue
at
the
time
of
harvest
and
method
used
to
determine
the
residue.
Trials
conducted
in
various
states
(
New
York,
Pennsylvania,
Virgina,
Missouri,
Oregon,
and
Washington)
and
on
various
apple
cultivars,
support
the
proposed
tolerance
exemption.
This
data
has
been
further
supported
by
numerous
trials
carried
out
internationally.
Residue
levels
following
the
maximum
number
(
4)
of
applications
on
apple
were
very
close
to
the
limit
of
quantitation
(
LOQ)
of
5
parts
per
billion
(
ppb)
at
normal
harvest,
which
averaged
80
days
after
the
last
application.
Trials
indicate
rapid
degradation
of
6­
BA
residues
among
all
the
apple
varieties
and
geographies
evaluated.
The
analytical
methods
for
detection
of
6­
BA
in
apple
raw
agricultural
and
processed
commodities
are
comprised
of
extraction,
cleanup
on
a
strong
cation
exchange
(
SCX)
solid­
phase
extraction
cartridge,
derivatisation
and
quantitation
by
gas
chromatography
(
GC).
These
were
developed
by
Valent
BioSciences
Corporation
and
submitted
to
EPA,
constituting
a
practical
analytical
method
for
detecting
and
measuring
levels
of
6­
BA
in
or
on
commodities,
with
a
LOQ
of
0.005
part
per
million
(
ppm)
that
allows
for
monitoring
of
food,
with
the
residues
at
or
above
the
LOQ.
Residue
data
on
6­
BA
use
on
pistachio
has
been
provided
to
EPA
by
Valent
BioSciences
Corporation.
Trials
were
conducted
in
locations
representing
the
major
pistachio
production
area
in
the
United
States.
No
residues
were
detected
following
the
maximum
number
(
2)
of
applications
at
normal
harvest,
which
averaged
60
days
after
the
last
application.
An
analytical
method
based
on
extraction,
clean
up
and
derivatisation
of
6­
BA
followed
by
quantitation
by
GC
was
submitted
to
EPA
for
residue
determination
on
pistachio.
This
GC
method
is
adequate
for
determining
residues
in
or
on
pistachios
with
a
LOQ
of
0.05
ppm.
3.
Why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
Usually,
a
request
for
an
exemption
from
the
requirement
of
a
tolerance
is
not
accompanied
by
residue
data
and
an
analytical
method.
Valent
BioSciences
Corporation
has
provided
this
information
to
the
Agency
in
this
case.
The
information
demonstrates
that
any
residue
is
detected
at
levels
very
close
to
the
LOQ.
Although
a
numeric
tolerance
could
be
established,
it
would
be
very
difficult
to
enforce,
as
demonstrated
by
the
risk
characterization.
Valent
BioSciences
Corporation
proposes
that
the
submitted
residue
data
and
analytical
method
support
their
conclusion
that
there
is
a
reasonable
certainty
that
no
harm
to
humans
or
the
environment
will
result
from
the
use
of
6­
BA
on
apples
and
pistachios.

C.
Mammalian
Toxicological
Profile
1.
Acute
toxicity.
The
oral
LD50
of
6­
BA
is
estimated
by
probit
analysis
at
1.3
gram/
kilogram
(
g/
kg)
in
the
rat.
The
dermal
LD50
in
the
rabbit
is
>
5.0
g/
kg.
The
acute
inhalation
LC50
in
the
rat
is
5.2
milligrams/
Liter
(
mg/
L)/
hour.
A
primary
eye
irritation
study
in
the
rabbit
showed
moderate
conjunctival
effects
which
cleared
within
7
days.
A
dermal
irritation
study
in
the
rabbit
showed
slight
dermal
irritation,
which
lasted
for
5
days.
Sensitization
potential
has
been
examined,
and
6­
BA
(
99%
pure)
was
demonstrated
not
to
be
a
dermal
sensitizer
in
guinea
pigs
under
conditions
of
the
study.
2.
Genotoxicity.
Mutagenicity
studies
including
Ames
test,
mouse
micronucleus
assay,
and
unscheduled
DNA
synthesis
(
UDS)
assay
in
rat
were
negative
for
mutagenic
effects.
3.
Developmental
toxicity.
Developmental
toxicity
in
rats
fed
6­
BA
(
99%
pure)
was
manifested
as
significantly
decreased
fetal
body
weight,
increased
incidence
of
hydrocephalas
and
unossified
sternbrae,
incompletely
ossified
phalanges,
and
malaligned
sternbrae
at
175
milligrams/
kilogram
body
weight/
day
(
mg/
kg
bwt/
day).
Maternal
toxicity
was
also
observed
at
175
mg/
kg
bwt/
day,
which
was
manifested
as
significantly
decreased
body
weight,
weight
gain,
and
food
consumption.
Thus
the
no
observed
adverse
effect
level
(
NOAEL)
and
lowest
observed
adverse
effect
level
(
LOAEL)
for
maternal
and
developmental
toxicity
was
50
and
175
mg/
kg
bwt/
day,
respectively.
4.
Subchronic
toxicity.
6­
Benzyladenine
(
99%
pure)
fed
to
rats
for
13
weeks
produced
decreased
weight
gain
at
1,500
and
5,000
ppm
(
121
and
322
mg/
kg
bwt/
day)
in
females,
and
5,000
ppm
(
295
mg/
kg
bwt/
day)
in
males.
This
decreased
weight
gain
appeared
to
be
related
to
decreased
food
consumption.
Serum
alkaline
phosphatase
activity
and
blood
urea
nitrogen
levels
were
increased
in
both
sexes
receiving
5,000
ppm;
thus
the
NOAEL
was
1,500
ppm
(
approximately
111
mg/
kg
bwt/
day
in
both
sexes
combined)
and
the
LOAEL
was
5,000
ppm
(
approximately
304
mg/
kg
bwt/
day
in
both
sexes),
based
on
the
decreased
body
weight
gain,
food
consumption,
increased
blood
urea
nitrogen,
and
minimal
histological
changes
in
the
kidneys.

D.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
In
conducting
this
exposure
assessment,
Valent
BioSciences
Corporation
used
very
conservative
assumptions,
100%
of
all
commodities
were
assumed
to
be
treated,
and
those
residues
would
be
at
twice
the
LOQ
­­
which
result
in
a
large
overestimate
of
human
exposure.
The
analysis
assumes
that
all
residues
have
the
same
magnitude,
and
the
treated
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146
/
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30,
2003
/
Notices
commodity
is
100%
of
a
daily
diet.
Thus,
in
making
a
safety
determination
for
these
tolerance
exemptions,
Valent
BioSciences
Corporation
took
into
account
this
very
conservative
exposure
assessment.
The
last
application
precedes
harvest
by
approximately
2.5
months
in
apples,
therefore
the
potential
for
dietary
exposure
is
considered
negligible
by
Valent
BioSciences
Corporation.
Application
precedes
harvest
by
approximately
2
months
in
pistachios.
Also
pistachios
have
their
hulls,
which
cover
the
shell,
removed
at
harvest,
therefore
the
potential
for
dietary
exposure
is
considered
negligible
by
Valent
BioSciences
Corporation.
Residues
are
below
the
LOQ
(
LOQ
=
0.05
ppm)
in
pistachio.
ii.
Drinking
water.
The
proposed
uses
on
apples
and
pistachios
are
not
expected
to
add
potential
exposure
to
drinking
water.
Soil
leaching
studies
have
suggested
that
6­
BA
is
relatively
immobile,
absorbing
to
sediment.
Residues
reaching
surface
waters
from
field
runoff
should
quickly
absorb
to
sediment
particles
and
be
partitioned
from
the
water
column.
6­
Benzyladenine
also
has
low
solubility
in
water,
0.061
mg/
mL,
and
detections
in
ground
water
are
not
expected.
Valent
BioSciences
Corporation
concludes
that
together
these
data
indicate
that
residues
are
not
expected
in
drinking
water.
2.
Non­
dietary
exposure.
The
proposed
uses
involve
application
of
6­
BA
to
crops
grown
in
an
agricultural
environment.
The
only
non­
dietary
exposure
expected
is
that
to
applicators.
However,
the
protective
measures
prescribed
by
the
product's
label
are
expected
to
be
adequate
to
minimize
exposure
and
protect
applicators
of
the
chemical.

E.
Cumulative
Exposure
No
cumulative
adverse
effects
are
expected
from
long­
term
exposure
to
this
chemical.
There
is
no
reliable
information
to
indicate
that
toxic
effects
produced
by
6­
BA
would
be
cumulative
with
those
of
any
other
pesticide
chemical.

F.
Safety
Determination
1.
U.
S.
population.
Chronic
dietary
exposure
estimates
were
conducted
for
the
overall
U.
S.
population
and
25
population
subgroups,
including
infants
and
children.
These
estimated
daily
intakes
were
compared
against
a
chronic
population
adjusted
dose
(
PAD)
based
on
a
NOAEL
of
50
mg/
kg
bwt/
day
from
a
developmental
study
in
rats.
To
account
for
intraspecies
and
interspecies
variation
and
the
use
of
an
acute
toxicological
endpoint
for
a
chronic
assessment,
an
uncertainty
factor
(
UF)
of
1,000
was
applied
to
the
acute
NOAEL.
This
resulted
in
a
chronic
PAD
of
0.05
mg/
kg
bwt/
day.
Daily
exposure
for
the
overall
U.
S.
population
was
estimated
to
be
0.000014
mg/
kg
bwt/
day,
representing
less
than
0.1%
of
the
estimated
chronic
PAD.
2.
Infants
and
children.
Estimated
daily
exposures,
assuming
that
100%
of
the
apple
and
pistachio
commodities
in
the
United
States
are
treated
with
6­
BA,
for
the
most
highly
exposed
population
subgroup,
non­
nursing
infants,
was
estimated
to
be
0.000085
mg/
kg
bwt/
day,
or
0.2%
of
the
estimated
chronic
PAD.

G.
Effects
on
the
Immune
and
Endocrine
Systems
6­
Benzyladenine
is
a
naturally
occurring
cytokinin
which
has
plant
growth
regulator
properties.
There
is
no
indication
that
this
plant
growth
regulator
belongs
to
a
class
of
chemicals
known
or
suspected
of
having
adverse
effects
on
the
immune
and
endocrine
systems.
It
can
be
concluded
that
based
upon
the
existing
toxicology
there
would
be
no
adverse
effects
on
the
immune
or
endocrine
systems
from
the
use
of
6­
BA.
Last,
there
is
no
evidence
that
6­
BA
bioaccumulates
in
the
environment.

H.
Existing
Tolerances
The
plant
growth
regulator
6­
BA
is
exempt
from
the
requirement
of
a
tolerance
when
used
as
a
fruit­
thinning
agent
at
an
application
rate
not
to
exceed
30
grams
of
active
ingredient
per
acre
in
or
on
apples.
6­
Benzyladenine
is
temporarily
exempt
from
the
requirement
of
a
tolerance
in
or
on
apples
at
 
182
grams
of
active
ingredient
per
acre
per
season,
and
in
or
on
pistachio
at
 
60
grams
of
active
ingredient
per
acre
per
season
when
used
in
accordance
with
the
Experimental
Use
Permit
73049
 
EUP
 
2.
The
exemption
from
a
tolerance
will
expire
on
January
31,
2005.

I.
International
Tolerances
There
are
no
codex,
Canadian,
or
Mexican
maximum
residue
limits
for
use
of
6­
BA
on
apple
or
pistachio.
[
FR
Doc.
03
 
19280
Filed
7
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0256;
FRL
 
7319
 
7]

Indian
Meal
Moth
Granulosis
Virus;
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
 
0256,
must
be
received
on
or
before
August
29,
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:
Leonard
Cole,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5412;
e­
mail
address:
cole.
leonard@
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
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
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.

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