Document ID: EPA-HQ-OPP-2002-0308-0001
Agency: epa
Document Type: Rule
Title: 6-Benzyladenine; Temporary  Exemption From the Requirement of a Tolerance
Posted Date: 2003-02-05T05:00Z

5835
Federal
Register
/
Vol.
68,
No.
24
/
Wednesday,
February
5,
2003
/
Rules
and
Regulations
drawn
westerly
from
the
shoreline
at
position
36
°
¥
56.001 
North
latitude,
76
°
¥
19.726 
West
longitude
to
a
point
at
36
°
¥
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North
latitude,
76
°
¥
20.152 
West
longitude,
thence
southerly
to
a
point
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36
°
¥
54.762 
North
latitude,
76
°
¥
20.244 
West
longitude,
then
southeasterly
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at
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°
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latitude,
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°
¥
20.093 
West
longitude,
then
to
the
shoreline
at
position
36
°
¥
54.216 
North
latitude,
76
°
¥
19.481 
West
longitude.
(
b)
Definitions:
The
designated
representative
of
the
Captain
of
the
Port
is
any
U.
S.
Coast
Guard
commissioned,
warrant
or
petty
officer
who
has
been
authorized
by
the
Captain
of
the
Port,
Hampton
Roads,
Virginia
to
act
on
his
behalf.
(
1)
The
Captain
of
the
Port,
Hampton
Roads
and
the
Command
Duty
Officer
at
the
Marine
Safety
Office,
Norfolk,
Virginia
can
be
contacted
at
telephone
Number
(
757)
668
 
5555.
(
2)
The
Coast
Guard
vessels
enforcing
the
security
zone
can
be
contacted
on
VHF
 
FM
channels
13
and
16.
(
c)
Regulation:
(
1)
In
accordance
with
the
general
regulations
in
165.33
of
this
part,
entry
into
this
zone
is
prohibited
unless
authorized
by
the
Captain
of
the
Port,
Hampton
Roads,
Virginia,
or
his
designated
representatives.
(
2)
The
operator
of
any
vessel
in
the
immediate
vicinity
of
this
security
zone
shall:
(
i)
Stop
the
vessel
immediately
upon
being
directed
to
do
so
by
any
commissioned,
warrant
or
petty
officer
on
board
a
vessel
displaying
a
U.
S.
Coast
Guard
Ensign.
(
ii)
Proceed
as
directed
by
any
commissioned,
warrant
or
petty
officer
on
board
a
vessel
displaying
a
U.
S.
Coast
Guard
Ensign.
(
d)
Effective
date:
This
section
is
effective
from
5
a.
m.
January
28,
2003
until
11:
59
p.
m.
February
4,
2003.

Dated:
January
28,
2003.
Lawrence
M.
Brooks,
Captain,
U.
S.
Coast
Guard,
Captain
of
the
Port,
Hampton
Roads.
[
FR
Doc.
03
 
2695
Filed
2
 
4
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0308;
FRL
 
7287
 
2]

6­
Benzyladenine;
Temporary
Exemption
From
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
biochemical
pesticide
6­
benzyladenine
on
apples
and
pistachios
when
applied/
used
in
accordance
with
the
Experimental
Use
Permit
73049­
EUP­
2.
Valent
BioSciences
Corporation
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
requesting
the
temporary
tolerance
exemption.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
6­
benzyladenine.
The
temporary
tolerance
exemption
will
expire
on
January
31,
2005.

DATES:
This
regulation
is
effective
February
5,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0308,
must
be
received
by
EPA
on
or
before
April
7,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Denise
Greenway,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
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)
 
Antimicrobial
pesticides
(
NAICS
32561)
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
 
2002
 
0308.
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/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
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.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
March
28,
2002
(
67
FR
14948)
(
FRL
 
6828
 
9),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
2G6378)

VerDate
Dec<
13>
2002
20:
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04,
2003
Jkt
200001
PO
00000
Frm
00043
Fmt
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Sfmt
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E:\
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05FER1
5836
Federal
Register
/
Vol.
68,
No.
24
/
Wednesday,
February
5,
2003
/
Rules
and
Regulations
by
Valent
BioSciences
Corporation,
870
Technology
Way,
Suite
100,
Libertyville,
IL
60048.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Valent
BioSciences
Corporation.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
to
expand
the
existing
tolerance
exemption
by
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
6­
benzyladenine.
Section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
exemption
is
``
safe.''
Section
408(
c)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue....''
Additionally,
section
408(
b)(
2)(
D)
of
the
FFDCA
requires
that
the
Agency
consider
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.

III.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness
and
reliability
and
the
relationship
of
this
information
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
toxicological
profile
for
6­
benzyladenine
has
been
previously
published
by
the
Agency
in
the
N6­
Benzyladenine
(
synonymous
with
the
subject
active
ingredient,
6­
benzyladenine)
Reregistration
Eligibility
Decision
(
RED)
document
of
June
1994
(
Ref.
1).
The
summarized
values
and
categories
for
the
various
studies
for
the
technical
active
ingredient
are
presented
here.
1.
Acute
toxicity.
Toxicity
Category
III
was
assigned
to
the
acute
oral
toxicity
study
in
the
rat
(
LD50
=
1.3
grams/
kilogram
(
g/
kg)),
and
in
the
eye
irritation
study
in
the
rabbit
(
moderate
irritant).
Toxicity
Category
IV
was
assigned
to
the
acute
dermal
toxicity
study
in
the
rabbit
(
LD50
>
5
g/
kg),
the
acute
inhalation
toxicity
study
in
the
rat
(
LC50
=
5.2
milligrams/
liter
(
mg/
L)),
and
in
the
dermal
irritation
study
in
the
rabbit
(
slight
irritant).
Additionally,
from
a
dermal
sensitization
study
in
the
guinea
pig,
it
was
determined
that
N6­
benzyladenine
is
not
a
dermal
sensitizer.
2.
Genotoxicity.
From
three
mutagenicity
studies
(
Ames
test,
mouse
micronucleus
assay,
and
unscheduled
DNA
synthesis
assay
in
the
rat),
it
was
determined
that
N6­
benzyladenine
is
not
mutagenic.
3.
Developmental
toxicity.
The
no
observed
adverse
effect
levels
(
NOAEL)
and
the
lowest
observed
adverse
effect
levels
(
LOAEL)
for
maternal
and
developmental
toxicity
in
rats,
respectively,
were
found
to
be
50
and
175
mg/
kg
of
body
weight
(
bwt)/
day,
respectively.
4.
Subchronic
toxicity.
For
rats
of
both
sexes,
the
NOAEL
was
approximately
111
mg/
kg
of
bwt/
day
and
the
LOAEL
was
approximately
304
mg/
kg
of
bwt/
day.

IV.
Aggregate
Exposures
In
examining
aggregate
exposure,
section
408
of
the
FFDCA
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).

A.
Dietary
Exposure
1.
Food.
Apple
and
pistachio
field
trials
performed
in
support
of
the
temporary
tolerance
exemption
request
and
the
associated
experimental
use
permit
yielded
acceptable
magnitude
of
the
residue
data
(
Ref.
2).
Residues
were
below
the
limit
of
quantitation
(
LOQ)
for
pistachios
treated
with
a
total
of
60
g
of
active
ingredient
(
a.
i.)
per
acre.
In
apples,
residues
of
6­
benzyladenine
were
consistently
near
the
LOQ.
However,
residues
did
not
increase
in
processed
commodities
(
relative
to
the
levels
on
the
raw
commodity),
and
were
below
the
LOQ.
Thus,
the
apple
field
data
are
adequate
to
support
the
temporary
tolerance
exemption
petition
and
experimental
program
to
apply
 
182
grams
of
active
ingredient
per
acre
per
season.
Also,
because
application
precedes
harvest
by
2
months
for
pistachio
and
by
approximately
2.5
months
for
apple,
the
potential
for
dietary
exposure
is
reduced.
Due
to
the
low
anticipated
dietary
intake
of
6­
benzyladenine
residues
relative
to
the
chronic
and
acute
population
adjusted
doses
(
see
Unit
VI,
below),
and
the
fact
that
actual
exposure
will
probably
be
considerably
less
because
the
dietary
exposure
analysis
was
based
on
worst­
case
assumptions,
it
is
highly
unlikely
that
the
proposed
new
uses
of
6­
benzyladenine
on
apples
and
pistachios
will
result
in
adverse
effects
to
human
health.
2.
Drinking
water
exposure.
The
proposed
uses
on
apples
and
pistachios
are
not
expected
to
add
potential
exposure
to
drinking
water.
Soil
leaching
studies
have
suggested
that
6­
benzyladenine
is
relatively
immobile
(
Ref.
3),
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,
76
±
2
mg/
L
at
20
°
C
(
Ref.
2),
and
detections
in
ground
water
are
not
expected.
Together,
these
data
indicate
that
residues
are
not
expected
in
drinking
water.

B.
Other
Non­
Occupational
Exposure
The
potential
for
non­
dietary
exposure
to
6­
benzyladenine
residues
for
the
general
population,
including
infants
and
children,
is
unlikely
because
the
uses
are
limited
to
experimental
applications
in
apple
and
pistachio
orchards.
Because
6­
benzyladenine
is
a
naturally
occurring
cytokinin
plant
regulator
(
Ref.
4,
5,
6,
7,
and
8),
it
is
a
normal
part
of
the
human
diet.
The
proposed
experimental
use
rates
are
well
below
the
toxicity
NOAELs.
The
residues
indicate
dietary
exposures
that
are
0.03%
and
0.01%
of
the
chronic
and
acute
population
adjusted
doses,
respectively.
Therefore,
while
there
exists
a
great
likelihood
of
prior
exposure
for
most,
if
not
all,
individuals
to
6­
benzyladenine,
any
increased
exposure
due
to
the
proposed
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Rules
and
Regulations
experimental
product
would
be
negligible
due
to
the
lack
of
residue
in
comparison
with
the
toxicity
NOAELs.

V.
Cumulative
Effects
The
Agency
has
considered
the
cumulative
effects
of
6­
benzyladenine
and
other
substances
in
relation
to
a
common
mechanism
of
toxicity.
These
considerations
include
the
possible
cumulative
effects
of
such
residues
on
infants
and
children.
Based
on
the
available
information
and
data
for
6­
benzyladenine,
no
mammalian
toxicity
is
expected
at
the
proposed
experimental
use
rates.
Therefore,
no
cumulative
effects
are
expected.

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
1.
U.
S.
population.
The
analysis
estimated
that
the
chronic
exposures
for
the
overall
U.
S.
population
was
0.000014
mg/
kg/
day
(
0.03%
of
the
chronic
population
adjusted
dose
(
cPAD)).
The
acute
dietary
estimated
exposure
was
0.000069
mg/
kg/
day
(
0.01%
of
the
acute
population
adjusted
dose
(
aPAD))
for
the
overall
U.
S.
population.
Critical
exposure
commodity
analysis
showed
that
apple
juice
contributed
the
most
to
dietary
exposure
for
the
overall
population.
Due
to
the
low
anticipated
dietary
intake
of
6­
benzyladenine
residues
relative
to
the
chronic
and
acute
population
adjusted
doses,
and
the
fact
that
actual
exposure
will
probably
be
considerably
less
because
the
dietary
exposure
analysis
was
made
based
on
worst­
case
assumptions,
it
is
likely
that
the
proposed
new
uses
of
6­
benzyladenine
on
apples
and
pistachios
will
not
result
in
adverse
effects
to
human
health.
2.
Infants
and
children.
The
analysis
estimated
that
the
chronic
exposures
for
the
most
highly
exposed
subgroup,
nonnursing
infants,
was
0.000085
mg/
kg/
day
(
0.2%
of
the
cPAD).
The
acute
dietary
estimated
exposure
was
0.000361
mg/
kg/
day
(
0.07%
of
aPAD)
for
the
most
highly
exposed
subgroup,
non­
nursing
infants.
Critical
exposure
commodity
analysis
showed
that
apple
juice
contributed
the
most
to
dietary
exposure
for
all
infants.
Due
to
the
low
anticipated
dietary
intake
of
6­
benzyladenine
residues
relative
to
the
chronic
and
acute
PAD,
and
the
fact
that
actual
exposure
will
probably
be
considerably
less
because
the
dietary
exposure
analysis
was
made
based
on
worst­
case
assumptions,
it
is
likely
that
the
proposed
new
uses
of
6­
benzyladenine
on
apples
and
pistachios
will
not
result
in
adverse
effects
to
human
health.
VII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
is
required
under
the
FFDCA
as
amended
by
FQPA
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate.''
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
is
no
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
6­
benzyladenine
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
Based
on
available
data,
no
endocrine
system­
related
effects
have
been
identified
with
consumption
of
6­
benzyladenine.
To
date,
there
is
no
evidence
to
suggest
that
6­
benzyladenine
affects
the
immune
system,
functions
in
a
manner
similar
to
any
known
hormone,
or
that
it
acts
as
an
endocrine
disruptor.

B.
Analytical
Method
The
Agency
is
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
the
reasons
stated
above.
For
the
same
reasons,
the
Agency
has
concluded
that
an
analytical
method
is
not
required
for
enforcement
purposes
for
6­
benzyladenine.

C.
Codex
Maximum
Residue
Level
Currently,
there
are
no
Codex,
Canadian
or
Mexican
maximum
residue
levels
for
residues
of
6­
benzyladenine
in/
on
apples
or
pistachios.
VIII.
Conclusions
Based
on
the
toxicology
information
submitted
and
reviewed
previously,
and
summarized
in
the
June
1994
N6­
Benzyladenine
RED
(
Ref.
1),
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
of
residues
of
6­
benzyladenine
to
the
U.
S.
population,
including
infants
and
children,
under
reasonably
foreseeable
circumstances,
when
the
biochemical
pesticide
is
used
in
accordance
with
good
agricultural
practices
under
the
conditions
of
the
2
 
year
experimental
program.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
based
on
the
data
submitted
previously
and
summarized
in
the
RED,
as
well
as
that
data
submitted
to
support
the
temporary
tolerance
exemption
and
Experimental
Use
Permit
applications,
demonstrating
negligible
dietary
exposure
in
comparison
with
the
toxicity
NOAELs.
As
a
result,
EPA
establishes
a
temporary
exemption
from
the
tolerance
requirements
pursuant
to
FFDCA
408(
c)
and
(
d)
for
residues
of
6­
benzyladenine
in
or
on
apples
and
pistachios.

IX.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d),
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2002
 
0308
in
the
subject
line
on
the
first
page
of
your
submission.
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24
/
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February
5,
2003
/
Rules
and
Regulations
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
April
7,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
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.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VIII.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2002
 
0308,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

X.
References
1.
U.
S.
EPA,
Reregistration
Eligibility
Decision
(
RED)
N6­
Benzyladenine,
June
1994.
2.
U.
S.
EPA;
Memorandum;
R.
S.
Jones
to
D.
Greenway;
October
2,
2002.
3.
Weigand,
R.,
et
al,
Metabolism
and
Movement
of
N­[
Phenylmethyl]­
1HPurin
6­
Amine
in
Soils,
1976.
Unpublished
study
received
January
13,
1977
for
EPA
Registration
Number
275­
32;
submitted
by
Abbott
Laboratories,
North
Chicago,
IL;
CDL:
095728­
C.
4.
Nandi,
S.
K.,
et
al,
Identification
of
cytokinins
in
primary
crown
gall
tumours
of
tomato,
Plant
Cell
and
Environment
(
1989)
12:
273­
283.
5.
Pechova,
D.,
et
al,
Identification
of
new
aromatic
cytokinins
in
plants,
17th
International
Conference
on
Plant
Growth
Substances,
July
1­
6,
2001.
6.
Strnad,
M.,
et
al,
Immunodectection
and
identification
of
N6­(
o­
hydroxybenzylamino)
purine
as
a
naturally
occurring
cytokinin
in
Populus
x
canadensis
Moench
cv
Robusta
leaves,
Plant
Physiol.
(
1992)
99:
74­
80.
7.
Strnad,
M.,
Enzyme
immunoassays
of
N6­
benzyladenine
and
N6­(
metahydroxybenzyl
adenine
cytokinins,
J
Plant
Growth
Regul.
(
1996)
15:
179­
188.
8.
Van
Staden,
J.
and
N.
R.
Crouch,
Benzyladenine
and
derivatives­
their
significance
and
interconversion
in
plants,
Plant
Growth
Regulation
(
1996)
19:
153­
175.

XI.
Statuatory
and
Executive
Order
Review
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
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Federal
Register
/
Vol.
68,
No.
24
/
Wednesday,
February
5,
2003
/
Rules
and
Regulations
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
exemption
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

XII.
Submission
to
Congress
and
the
Comptroller
General
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule
''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
January
16,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
374.

2.
Section
180.1150
of
subpart
D
is
revised
to
read
as
follows:

§
180.1150
6­
Benzyladenine;
exemption
from
the
requirement
of
a
tolerance.

(
a)
The
plant
growth
regulator
6­
benzyladenine
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.
(
b)
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
temporary
exemption
from
a
tolerance
will
expire
on
January
31,
2005.
[
FR
Doc.
03
 
2431
Filed
2
 
4
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0344;
FRL
 
7289
 
7]

Cyprodinil;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
cyprodinil
in
or
on
the
bushberry
subgroup,
caneberry
subgroup,
juneberry,
lingonberry,
pistachio,
salal
and
watercress.
The
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
February
5,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0344,
must
be
received
on
or
before
April
7,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
besubmitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368;
e­
mail
address:
jamerson.
hoyt@
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
Code
111)
 
Animal
production
(
NAICS
Code
112)
 
Food
manufacturing
(
NAICS
Code
311)
 
Pesticide
manufacturing
(
NAICS
Code
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
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