Document ID: EPA-HQ-OPP-2002-0303-0001
Agency: epa
Document Type: Rule
Title: Mesotrione; Pesticide Tolerance
Posted Date: 2003-01-03T05:00Z

269
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
18
CFR
Part
385
Administrative
practice
and
procedure,
Electric
power,
Penalties,
Pipelines,
Reporting
and
recordkeeping
requirements.

By
the
Commission.
Linwood
A.
Watson,
Jr.,
Deputy
Secretary.

In
consideration
of
the
foregoing,
the
Commission
amends
parts
260,
357
and
385,
Chapter
I,
Title
18,
of
the
Code
of
Federal
Regulations,
as
follows:

PART
260
 
STATEMENTS
AND
REPORTS
(
SCHEDULES)

1.
The
authority
citation
for
part
260
continues
to
read
as
follows:

Authority:
15
U.
S.
C.
717
 
717w,
3301
 
3432;
42
U.
S.
C.
7101
 
7352.

2.
In
§
260.1,
paragraph
(
b)
is
revised
to
read
as
follows:

§
260.1
FERC
Form
No.
2,
Annual
report
for
Major
natural
gas
companies
*
*
*
*
*
(
b)
Filing
requirements.
Each
natural
gas
company,
as
defined
in
the
Natural
Gas
Act
(
15
U.
S.
C.
717,
et
seq.)
which
is
a
major
company
(
a
natural
gas
company
whose
combined
gas
transported
or
stored
for
a
fee
exceeded
50
million
Dth
in
each
of
the
three
previous
calendar
years)
must
prepare
and
file
with
the
Commission,
on
or
before
April
30
following
the
close
of
each
calendar
year,
FERC
Form
No.
2.
Newly
established
entities
must
use
projected
data
to
determine
whether
FERC
Form
No.
2
must
be
filed.
The
form
must
be
filed
in
electronic
format
only,
as
indicated
in
the
general
instructions
set
out
in
that
form.
The
format
for
the
electronic
filing
can
be
obtained
at
the
Federal
Energy
Regulatory
Commission,
Division
of
Information
Services,
Public
Reference
and
Files
Maintenance
Branch,
Washington,
DC
20426.
One
copy
of
the
report
must
be
retained
by
the
respondent
in
its
files.
3.
In
§
260.2,
paragraph
(
b)
is
revised
to
read
as
follows:

§
260.2
FERC
Form
No.
2
 
A,
Annual
report
for
Nonmajor
natural
gas
companies
*
*
*
*
*
(
b)
Filing
requirements.
Each
natural
gas
company,
as
defined
by
the
Natural
Gas
Act,
not
meeting
the
filing
threshold
for
FERC
Form
No.
2,
but
having
total
gas
sales
or
volume
transactions
exceeding
200,000
Dth
in
each
of
the
three
previous
calendar
years,
must
prepare
and
file
with
the
Commission,
on
or
before
March
31
following
the
close
of
each
calendar
year,
FERC
Form
No.
2
 
A.
Newly
established
entities
must
use
projected
data
to
determine
whether
FERC
Form
No.
2
 
A
must
be
filed.
The
form
must
be
filed
in
electronic
format
only,
as
indicated
in
the
general
instructions
set
out
in
that
form.
The
format
for
the
electronic
filing
can
be
obtained
at
the
Federal
Energy
Regulatory
Commission,
Division
of
Information
Services,
Public
Reference
and
Files
Maintenance
Branch,
Washington,
DC
20426.
One
copy
of
the
report
must
be
retained
by
the
respondent
in
its
files.

PART
357
 
ANNUAL
SPECIAL
OR
PERIODIC
REPORTS:
CARRIERS
SUBJECT
TO
PART
I
OF
THE
INTERSTATE
COMMERCE
ACT
4.
The
authority
citation
for
part
357
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7101
 
7352,
49
U.
S.
C.
60502,
49
App.
U.
S.
C.
1
 
85
(
1988).

5.
In
§
357.2,
paragraph
(
c)(
3)
is
revised
to
read
as
follows:

§
357.2
FERC
Form
No.
6,
Annual
Report
of
Oil
Pipeline
Companies
*
*
*
*
*
(
c)
What
to
submit.
*
*
*
(
3)
The
form
must
be
filed
in
electronic
format
only
pursuant
to
§
385.2011
of
this
chapter,
beginning
with
report
year
2002,
due
on
or
before
March
31,
2003.

PART
385
 
RULES
OF
PRACTICE
AND
PROCEDURE
6.
The
authority
citation
for
part
385
continues
to
read
as
follows:

Authority:
5
U.
S.
C.
551
 
557;
15
U.
S.
C.
717
 
717z,
3301
 
3432;
16
U.
S.
C
791a
 
825r,
2601
 
2645;
31
U.
S.
C.
9701;
42
U.
S.
C.
7101
 
7352;
49
U.
S.
C.
60502;
49
App.
U.
S.
C.
1
 
85
(
1988).

7.
In
§
385.2011,
paragraph
(
c)(
3)
is
revised
to
read
as
follows:

§
385.2011
Procedures
for
filing
on
electronic
media
(
Rule
2011).

*
*
*
*
*
(
c)
What
to
file.*
*
*
(
3)
With
the
exception
of
the
Form
Nos.
1,
2,
2
 
A
and
6,
the
electronic
media
must
be
accompanied
by
the
traditional
prescribed
number
of
paper
copies.
*
*
*
*
*
[
FR
Doc.
03
 
153
Filed
1
 
2
 
03;
8:
45
am]

BILLING
CODE
6717
 
01
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0303;
FRL
 
7282
 
4]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
mesotrione
in
or
on
corn,
pop,
grain
and
corn,
pop,
stover.
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
January
3,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0303,
must
be
received
on
or
before
March
4,
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
VI.
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:
 
Industry
(
NAICS
111,
112,
311,
32532),
Crop
production,
Animal
production,
Food
manufacturing,
Pesticide
manufacturing.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
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
VerDate
Dec<
13>
2002
14:
59
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00015
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
03JAR1.
SGM
03JAR1
270
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
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
 
0303.
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.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
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
August
7,
2002
(
67
FR
51270)
(
FRL
 
7186
 
5),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP
2F6443
and
2E6465)
by
IR­
4,
681
US
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petitions
prepared
by
Sygenta
Crop
Protection
Inc.,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.571
be
amended
by
establishing
a
tolerance
for
residues
of
the
herbicide
mesotrione,
2­[
4­(
methylsulfonyl)­
2­
nitrobenzoyl]­
1,3­
cyclohexanedione,
in
or
on
corn,
pop
grain
and
corn,
pop
stover
at
0.01
parts
per
million
(
ppm).
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
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
*
*
*''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
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.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
mesotrione
on
corn,
pop
grain
and
corn,
pop
stover
at
0.01
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.
A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
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
nature
of
the
toxic
effects
caused
by
mesotrione
is
discussed
in
Unit
III.
A.
of
the
final
rule
on
the
Mesotrione
Pesticide
Tolerance
published
in
the
Federal
Register
of
June
21,
2001
(
66
FR
33187)
(
FRL
 
6787
 
7).

B.
Toxicological
Endpoints
A
summary
of
the
toxicological
endpoints
for
mesotrione
used
for
human
risk
assessment
is
discussed
in
Unit
III.
B.
of
the
final
rule
on
Mesotrione
Pesticide
Tolerance
published
in
the
Federal
Register
of
June
21,
2001
(
66
FR
33187).
A
chronic
aggregate
risk
assessment
is
appropriate
for
mesotrione
and
was
performed
by
EPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.517)
for
the
residues
of
mesotrione,
in
or
on
the
following
raw
agricultural
commodities:
Field
corn:
Grain,
fodder
and
forage,
each
at
0.01
ppm.
A
section
18
registration
was
granted
to
the
State
of
Wisconsin
for
time­
limited
tolerances
(
expires
June
2004)
for
sweet
corn:
Kernel,
forage
and
stover
at
0.01,
0.5
and
2.0,
respectively.
Risk
assessments
conducted
by
EPA
to
assess
dietary
exposures
from
mesotrione
are
discussed
in
Unit
III
C.
1
on
the
final
rule
of
Mesotrione
Pesticide
Tolerance
published
in
the
Federal
Register
of
June
21,
2001
(
66
FR
33187).
2.
Dietary
exposure
from
drinking
water.
GENEEC
and
SCI­
GROW
models
were
used
for
the
estimated
environmental
concentrations
(
EECs)
of
mesotrione
for
acute
and
chronic
exposures.
See
Unit
III
C.
2
for
discussion
in
the
final
rule
of
Mesotrione
Pesticide
Tolerance
published
in
the
Federal
Register
of
June
21,
2001
(
66
FR
33187).
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
Mesotrione
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.

VerDate
Dec<
13>
2002
14:
59
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00016
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
03JAR1.
SGM
03JAR1
271
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
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
does
not
have,
at
this
time,
available
data
to
determine
whether
mesotrione
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,
mesotrione
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
mesotrione
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
There
is
quantitative
evidence
of
increased
susceptibility
demonstrated
in
the
oral
prenatal
developmental
toxicity
studies
in
rats,
mice,
and
rabbits.
Delayed
ossification
was
seen
in
the
fetuses
at
doses
below
those
at
which
maternal
toxic
effects
were
noted.
Maternal
toxic
effects
in
the
rat
were
decreased
body
weight
gain
during
treatment
and
decreased
food
consumption
and
in
the
rabbit,
abortions
and
GI
effects.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
mesotrione
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
FQPA
safety
factor
(
10x)
is
retained
in
assessing
the
risk
posed
because
there
is
quantitative
evidence
of
increased
susceptibility
of
the
young
exposed
to
mesotrione
in
the
prenatal
developmental
toxicity
studies
in
mice,
rats,
and
rabbits
and
in
the
multigeneration
reproduction
study
in
mice,
there
is
qualitative
evidence
of
increased
susceptibility
of
the
young
exposed
to
mesotrione
in
the
multigeneration
reproduction
study
in
rats;
and
a
Developmental
Neurotoxicity
Study
is
required
to
assess
the
effects
of
tyrosinemia
on
the
developing
nervous
system
exposed
to
mesotrione.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
EPA
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Acute
doses
and
endpoints
were
not
selected
for
the
general
U.
S.
population
(
including
infants
and
children)
or
the
females
13­
50
years
old
population
subgroup
for
mesotrione;
therefore,
acute
dietary
risk
is
not
expected.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
mesotrione
from
food
will
utilize
2.1%
of
the
cPAD
for
the
U.
S.
population,
4.4%
of
the
cPAD
for
infants
(<
1
year
old)
and
5.0%
of
the
cPAD
for
children
1­
6
years
old.
There
are
no
residential
uses
for
mesotrione
that
result
in
chronic
residential
exposure
to
mesotrione.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
mesotrione
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table:

AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
MESOTRIONE
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.0
007
2.1
4.3
0.1
5
24
Infants
(<
1
year
old)
0.0
007
4.4
4.3
0.15
6.7
Children
(
1­
6
years
old)
0.0
007
5.0
4.3
0.15
6.7
VerDate
Dec<
13>
2002
14:
59
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00017
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
03JAR1.
SGM
03JAR1
272
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
MESOTRIONE
 
Continued
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

Females
(
13­
50
years
old)
0.0
007
1.6
4.3
0.15
20.7
3.
Aggregate
cancer
risk
for
U.
S.
population.
In
accordance
with
the
EPA
Draft
Guidelines
for
Carcinogen
Risk
Assessment
(
July,
1999),
the
Agency
classified
mesotrione
as
``
not
likely
to
be
carcinogenic
to
humans''
by
all
routes
of
exposure
based
upon
lack
of
evidence
of
carcinogenicity
in
rats
and
mice;
therefore,
cancer
risk
is
not
expected.
4.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
mesotrione
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
(
high
pressure
liquid
chromatography)
is
available
to
enforce
the
tolerance
expression.
Adequate
enforcement
methodology
(
example
 
gas
chromotography)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Francis
Griffith,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
Environmental
Protection
Agency,
701
Mapes
Road,
Fort
George
G.
Mead,
MD
20755
 
5350;
telephone
number
(
410)
305
 
2905;
griffith.
francis@
epa.
gov.

B.
International
Residue
Limits
There
are
no
CODEX,
Canadian,
or
Mexican
tolerances/
Maximum
Residue
Levels
for
mesotrione
residues.
Thus,
harmonization
is
not
an
issue
at
this
time.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
mesotrione,
2­[
4­
(
methylsulfonyl)­
2­
nitrobenzoyl]­
1,3­
cyclohexanedione,
in
or
on
corn,
pop,
grain
and
corn,
pop,
stover
at
0.01
ppm.

VI.
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)
of
FFDCA,
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
 
0303
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
March
4,
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
VI.
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
 
0303,
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
VerDate
Dec<
13>
2002
14:
59
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00018
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
03JAR1.
SGM
03JAR1
273
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
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).

VII.
Regulatory
Assessment
Requirements
This
final
rule
establishes
a
tolerance
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
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
tolerance
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.

VIII.
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:
December
20,
2002.
Debra
Edwards,
Acting
Director,
Registration
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
371.
2.
Section
180.571
is
amended
by
alphabetically
adding
commodities
to
the
table
in
paragraph
(
a)
to
read
as
follows:

§
180.571
Mesotrione.
(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*

Corn,
pop,
grain
0.01
Corn,
pop,
stover
0.01
*
*
*
*
*

[
FR
Doc.
03
 
4
Filed
1
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
VerDate
Dec<
13>
2002
14:
59
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00019
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
03JAR1.
SGM
03JAR1