15945
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
Coronado
Beach
bridge
(
SR
44),
mile
845,
shall
open
on
signal,
except
that
from
7
a.
m.
until
7
p.
m.,
each
day
of
the
week,
the
draw
need
only
open
on
the
hour,
twenty
minutes
past
the
hour
and
forty
minutes
past
the
hour.
*
*
*
*
*

Dated:
March
21,
2003.
James
S.
Carmichael,
Rear
Admiral,
U.
S.
Coast
Guard,
Commander,
Seventh
Coast
Guard
District.
[
FR
Doc.
03
 
7996
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0046;
FRL
 
7299
 
8]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
Smetolachlor
Acetamid,
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)­,
(
S)
and
its
metabolites,
determined
as
the
derivatives,
2­(
2­
ethyl­
6­
methylphenyl)
amino­
1­
propanol
and
4­(
2­
ethyl­
6­
methylphenyl)­
2­
hydroxy­
5­
methyl­
3­
morpholinone,
each
expressed
as
the
parent
compound
S­
metolachlor
in
or
on
the
raw
agricultural
commodities
grass
forage,
grass
hay,
spinach,
sugar
beet,
sugar
beet
molasses,
sugar
beet
tops,
sunflower
seed,
sunflower
meal,
and
tomato.
The
Interregional
Research
Project
No.
4
(
IR­
4)
and
Syngenta
Crop
Protection
requested
theses
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
April
2,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0046,
must
be
received
on
or
before
June
2,
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:
Joanne
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6224;
e­
mail
address:
miller.
joanne@
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
manufacture.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0046.
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
January
29,
2003,
(
68
FR
4470
 
4475)
(
FRL
 
7281
 
3),
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
6E4638,
8E5011,
6F6751,
and
7F4897)
by
the
Interregional
Research
Project
No.
4
(
IR­
4),
and
Syngenta
Crop
Protection,
New
Jersey
Agricultural
Experiment
Station,
P.
O.
Box
231,
Rutgers
University,
New
Brunswick,
NJ
08903
and
410
Swing
Road,
Greensboro,
NC
27419.
That
notice
included
a
summary
of
the
petition
prepared
by
IR­
4
and
Syngenta,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.368(
a)
be
amended
by
establishing
a
tolerance
for
combined
residues
of
the
herbicide
S­
metolachlor
Acetamid,
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)­,
(
S)
and
its
metabolites,
determined
as
the
derivatives,
2­(
2­
ethyl­
6­
methylphenyl)
amino­
1­
propanol
and
4­
(
2­
ethyl­
6­
methylphenyl)­
2­
hydroxy­
5­
methyl­
3­
morpholinone,
each
expressed
as
the
parent
compound
in
or
on
the
raw
agricultural
commodities
grass
forage
at
12.0
parts
per
million
(
ppm),
grass
hay
at
0.02
ppm,
spinach
at
0.5
ppm,
sugar
beet
at
0.5
ppm,
sugar
beet
dried
pulp
at
1.0
ppm,
sugar
beet
molasses
at
3.0
ppm,
sugar
beet
tops
at
15.0
ppm,
sunflower
at
0.5
ppm,
sunflower
meal
at
1.0
ppm,
and
tomato
at
0.1
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
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/
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2,
2003
/
Rules
and
Regulations
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
combined
residues
of
Acetamid,
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­
methoxy­
1­
methylethyl)­,
(
S)
and
its
metabolites,
determined
as
the
derivatives,
2­(
2­
ethyl­
6­
methylphenyl)
amino­
1­
propanol
and
4­(
2­
ethyl­
6­
methylphenyl)­
2­
hydroxy­
5­
methyl­
3­
morpholinone,
each
expressed
as
the
parent
compound
in
or
on
the
raw
agricultural
commodities;
grass
forage
at
10.0
ppm;
grass
hay
at
0.02
ppm;
spinach
at
0.5
ppm;
sugar
beet
roots
at
0.5
ppm;
sugar
beet
molasses
at
3.0
ppm;
sugar
beet
tops
at
15.0
ppm;
sunflower
seeds
at
0.5
ppm;
sunflower
meal
at
1.0
ppm;
and
tomato
at
0.1
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Profile
Metolachlor
is
a
chloroacetanilide
herbicide
that
was
first
registered
for
use
in
1976.
Racemic
metolachlor
consists
of
50%
each
of
the
Renantiomer
(
CGA
77101)
and
the
Senantiomer
(
CGA
77102,
or
alpha
metolachlor).
The
S­
enantiomer
is
the
herbicidally
active
isomer.
Smetolachlor
is
a
racemic
mixture
comprised
of
88%
S­
enantiomer
and
12%
R­
enantiomer.
Toxicity
data
has
been
submitted
on
both
metolachlor
and
S­
metolachlor.
The
Agency
has
determined
that
S­
metolachlor
has
either
comparable
or
decreased
toxicity
as
compared
to
racemic
metolachlor.
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
metolachlor
are
discussed
in
Table
1a
below
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1A.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
FOR
METOLACHLOR
(
PC
CODE
108801)

Guideline
No.
Study
Type
Results
870.3100
90­
Day
oral
toxicity
rodents
NOAEL
=
210
milligram/
kilogram/
day
(
mg/
kg/
day)
for
males
LOAEL
for
males
was
not
established
NOAEL
=
23.4
mg/
kg/
day
for
females
LOAEL
=
259
mg/
kg/
day
for
females
based
on
decreased
body
weight/
body
weight
gain
870.3150
90­
Day
oral
toxicity
in
nonrodents
NOAEL
=
8.77
mg/
kg/
day
LOAEL
=
29.42
mg/
kg/
day
based
on
decreased
body
weight
gain
870.3200
21­
28
day
dermal
Systemic
NOAEL
=
1,000
mg/
kg/
day
Systemic
LOAEL
was
not
established
dermal
irritation
NOAEL
was
not
established
dermal
irritation
LOAEL
=
10
mg/
kg/
day
based
on
very
slight
erythema,
dry
skin
and
fissuring
(
one
animal)

870.3700
Prenatal
developmental
in
rodents
Maternal
NOAEL
=
300
mg/
kg/
day
Maternal
LOAEL
=
1,000
mg/
kg/
day
based
on
an
increased
incidence
of
death,
clinical
signs
of
toxicity
(
clonic
and/
or
toxic
convulsions,
excessive
salivation,
urinestained
abdominal
fur
and/
or
excessive
lacrimation)
and
decreased
body
weight
gain.
Developmental
NOAEL
=
300
mg/
kg/
day
Developmental
LOAEL
=
1000
mg/
kg/
day
based
on
slightly
decreased
number
of
implantations
per
dam,
decreased
number
of
live
fetuses/
dam,
increased
number
of
resorptions/
dam
and
significant
decrease
in
mean
fetal
body
weight
870.3700
Prenatal
developmental
in
nonrodents
Maternal
Toxicity
NOAEL
=
120
mg/
kg/
day
Maternal
Toxicity
LOAEL
=
360
mg/
kg/
day
based
on
an
increased
incidence
of
clinical
observations
(
persistent
anorexia)
and
decreased
body
weight
gain
Developmental
Toxicity
NOAEL
=
360
mg/
kg/
day
Developmental
Toxicity
LOAEL
was
not
established
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63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
TABLE
1A.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
FOR
METOLACHLOR
(
PC
CODE
108801)
 
Continued
Guideline
No.
Study
Type
Results
870.3800
Reproduction
and
fertility
effects
Parental
Toxicity
NOAEL
=
75.8
mg/
kg/
day
(
F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1
males/
females:
76.6/
84.5
mg/
kg/
day).
Parental
LOAEL
was
not
established
Reproductive
toxicity
NOAEL
=
75.8
mg/
kg/
day
(
F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1
males/
females:
76.6/
84.5
mg/
kg/
day).
Reproductive
toxicity
LOAEL
was
not
established
Offspring
NOAEL
=
23.5
mg/
kg/
day
(
F0
males/
females:
23.5/
26.0
mg/
kg/
day;
F1
males/
females:
23.7/
25.7
mg/
kg/
day)
Offspring
LOAEL
=
75.8
mg/
kg/
day
based
on
F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1
males/
females:
76.6/
84.5
mg/
kg/
day)
based
on
decreased
body
weight.

870.4100
Chronic
toxicity
dogs
NOAEL
=
9.7
mg/
kg/
day
for
females
LOAEL
=
33mg/
kg/
day
for
females
based
on
decreased
body
weight
NOAEL
=
32.7
mg/
kg/
day
for
males.
LOAEL
for
males
was
not
established
870.4300
Chronic
Toxicity/
Carcinogenicity
in
Rodents
NOAEL
=
15
mg/
kg/
day
for
females
LOAEL
=
150
mg/
kg/
day
for
females
based
on
slightly
decreased
body
weight
gain
and
food
consumption.
The
NOAEL
=
150
mg/
kg/
day
for
males.
The
LOAEL
was
not
established
for
males.
Administration
of
doses
up
to
3,000
ppm
(
150
mg/
kg/
day)
was
associated
with
statistically
significant
increases
in
liver
adenomas
and
combined
adenoma/
carcinoma
in
female
rats.
In
male
rats,
there
was
a
statistically
significant
trend
but
not
pair­
wise
significance
for
liver
tumors.

870.4300
Carcinogenicity
mice
NOAEL
=
150
mg/
kg/
day
LOAEL
=
450
mg/
kg/
day
based
on
possible
treatment­
related
deaths
in
females
and
decreased
body
weight/
body
weight
gain
in
males
and
females
no
evidence
of
carcinogenicity
870.5100
Gene
mutation
­
bacterial
reverse
mutation
negative
up
to
cytotoxic
doses
(
1,000
µ
g/
plate)

870.5300
Gene
mutation
­
mouse
lymphoma
no
effect
on
the
incidence
of
mutations
in
the
presence
or
absence
of
metabolic
activation
870.5395
Cytogenetics
Micronucleus
assey
in
Chinese
hampsters
no
effect
of
treatment
on
incidence
of
micronuclei
induction
870.5450
Cytogenetics
dominant
lethal
assey
in
mice
no
effect
on
embryonic
death,
pre­
and
post­
implantation
or
fertility
rates
in
mated
females
870.5550
Other
Effects
DNA
Damage
Repair
in
rat
hepatocytes
negative
870.5550
Other
Effects
DNA
Damage
Repair
in
human
fibroblasts
negative
870.5550
Other
Effects
Unscheduled
DNA
synthesis
in
rat
hepatocytes
negative
for
induction
of
UDS;
however,
significant
increases
in
percentage
of
cells
in
S­
phase
were
observed
in
females
dosed
at
500
mg/
kg
(
but
not
at
1,000
or
1,500
mg/
kg)
and
sacrificed
at
15
hours
870.7485
Metabolism
and
pharmacokinetics
Unacceptable
The
major
metabolic
pathway
proposed
from
analysis
of
urinary
as
well
as
fecal
metabolites
is
one
of
cleavage
of
the
ether
bond
and
subsequent
oxidation
to
the
carboxylic
acid,
as
well
as
hydrolytic
removal
of
the
chlorine
atom.
Conjugation
of
CGA
24705
or
metabolites
with
gluronic
acid
or
sulfate
does
not
appear
to
occur.
Aqueous
extractable
urinary
radioactivity
contained
58%
of
the
total
urinary
radioactivity
and
was
composed
of
5
different
radioactive
fractions,
which
were
not
identified.
Current
guideline
recommendations
as
to
dose
levels
and
use
of
both
sexes
in
metabolism
studies
were
not
followed.
Thus,
whether
the
metabolic
pattern
is
altered
with
dose
or
repeated
exposure
cannot
be
evaluated
from
these
data.

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Rules
and
Regulations
TABLE
1A.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
FOR
METOLACHLOR
(
PC
CODE
108801)
 
Continued
Guideline
No.
Study
Type
Results
870.7485
Metabolism
and
pharmacokinetics
Unacceptable
Conclusions:
Single
low
(
1.5
mg/
kg),
single
high
(
300
mg/
kg)
and
repeated
low
(
1.5
mg/
kg/
day
for
15
days)
oral
doses
of
metolachlor
were
readily
absorbed
and
eliminated
by
male
and
female
rats.
Urinary
and
fecal
elimination
of
radioactivity
associated
with
orally
administered
14C
metolachlor
was
essentially
complete
within
48
to
72
hours
after
dosing.
Low­
and
high­
dose
females
eliminated
14C
more
rapidly
(
p<
0.003,
half­
lives
of
elimination,
16.6
and
15.6
hours,
respectively)
than
low­
and
high­
dose
males
and
repeated­
dose
animals
of
both
sexes
(
half­
lives,
18.2
and
20.0
hours).
Elimination
by
all
animals
followed
first­
order
kinetics.
Approximately
one­
half
to
two­
thirds
(
48
to
64
percent)
of
the
14C
administered
was
recovered
from
the
urine
within
7
days;
similar
amounts
were
present
in
the
feces.
Low­
dose
males
eliminated
slightly
more
of
the
radioactive
dose
in
the
feces
(
55
percent)
than
the
urine
(
48
percent).
The
opposite
trend
was
seen
in
the
low­
dose
females
and
repeated­
dose
rats
of
both
sexes;
these
animals
excreted
approximately
58
to
64
percent
of
the
14C
dose
in
the
urine
and
42.5
to
46.5
percent
in
the
feces
within
7
days
after
dosing.
High­
dose
animals
excreted
similar
amounts
(
58
to
60
percent)
of
the
radioactive
dose
in
the
urine
and
feces.
Total
recoveries
of
14C
(
urine,
feces,
and
tissues)
tended
to
be
high
and
were
between
105
and
122.5
percent.

870.7485
Metabolism
and
pharmacokinetics
In
a
rat
metabolism
study
(
MRID
#
431642
 
01),
14C­
Metolachlor
was
administered
orally
in
PEG
 
200
HWI
6117
 
208
or
corn
oil
ABR
 
94001
to
groups
(
5
sex/
dose)
of
male
and
female
Sprague­
Dawley
rats
at
a
low
oral
dose
(
1.5
mg/
kg),
repeated
low
oral
dose
(
1.5
mg/
kg
x
14
days),
and
a
single
high
dose
(
300
mg/
kg).
Control
animals
(
1/
sex)
received
blank
formulation.
Comparison
of
oral
and
intravenous
data
showed
that
of
the
administered
dose,
between
69.6%
and
93.2%
was
absorbed.
Distribution
data
showed
that
the
only
significant
sites
of
residual
radioactivity
at
7
days
post­
dose
were
residual
carcass
(
0.9
 
2.2%
of
the
administered
dose)
and
red
blood
cells
(
0.95
 
1.53
µ
g
equivalents
gram
in
blood
cells
for
all
low
dose
male
and
female
rats).
Dosing
regimen
did
not
result
in
any
apparent
accumulation
of
residual
radioactivity.
Excretion
data
showed
that
urine
and
feces
were
both
significant
routes
for
elimination
of
metolachlor
derived
radioactivity.
In
the
low
dose
groups,
the
urine
appeared
more
of
a
predominant
route
for
excretion
in
female
rats
than
in
males,
whereas
fecal
excretion
was
slightly
higher
in
males.
However,
at
the
high
oral
dose,
there
were
no
apparent
sex­
related
differences
in
the
pattern
of
urinary
excretion
Examination
of
urinary
excretion
data
as
presented
in
graphical
format
indicated
that
at
the
300
mg/
kg
dose,
excretion
was
delayed
vs
the
low
oral
dose,
suggesting
saturation
of
elimination.

The
nature
of
the
toxic
effects
caused
by
S­
metolachlor
are
discussed
in
Table
1b
below
as
well
as
the
NOAEL
and
the
LOAEL
from
the
toxicity
studies
reviewed.

TABLE
1B.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
FOR
S­
METOLACHLOR
(
PC
CODE
108800)

Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
NOAEL
=
15
milligram/
kilogram/
day
(
mg/
kg/
day)
LOAEL
=
150
mg/
kg/
day
based
on
lower
body
weights/
body
weight
gains,
reduced
food
consumption
and
food
efficiency
and
increased
kidney
weights
in
males
870.3100
90
 
Day
oral
toxicity
rodents
NOAEL
=
208
mg/
kg/
day
in
males
and
236
mg/
kg/
day
in
females
LOAEL
was
not
defined.

870.3150
90
 
Day
oral
toxicity
in
nonrodents
NOAEL
=
62
mg/
kg/
day
in
males
and
74
mg/
kg/
day
in
females
LOAEL
=
was
not
established
870.3700
Prenatal
developmental
in
rodents
Maternal
NOAEL
=
50
mg/
kg/
day
LOAEL
=
500
mg/
kg/
day
based
on
increased
clinical
signs
of
toxicity,
decreased
body
weights/
body
weight
gains,
food
consumption
and
food
efficiency.
Developmental
NOAEL
=
1,000
mg/
kg/
day
LOAEL
was
not
established
870.3700
Prenatal
developmental
in
nonrodents
Maternal
NOAEL
=
20
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
based
on
clinical
signs
of
toxicity
Developmental
NOAEL
=
500
mg/
kg/
day
LOAEL
was
not
established
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Vol.
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No.
63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
TABLE
1B.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
FOR
S­
METOLACHLOR
(
PC
CODE
108800)
 
Continued
Guideline
No.
Study
Type
Results
870.5100
Gene
Mutation
Test
There
was
no
indication
that
S­
metolachlor
technical
induced
a
mutagenic
effect
in
any
tester
strain
either
in
the
presence
or
the
absence
of
S9
activation.

870.5395
Cytogenetics
Micronucleus
test
There
was
no
evidence
that
S­
metolachlor
technical
induced
a
clastogenic
or
aneugenic
effect
in
either
sex
at
any
dose
or
sacrifice
time.

870.5550
Other
Effects
Unscheduled
DNA
synthesis
S­
metolachlor
technical
was
negative
for
genotoxicity
but
positive
for
cellular
proliferation
when
tested
up
to
overtly
toxic
and
cytotoxic
doses
in
this
in
vivo/
in
vitro
rat
hepatocyte
RDS/
UDS
assay.

870.7485
Metabolism
and
pharmacokinetics
S­
metolachlor
has
a
high
affinity
for
and
a
long
half­
life
in
blood
(
especially
RBC)
which
might
contribute
to
the
retarded
depletion
of
tissue
residues.

870.7485
Metabolism
and
pharmacokinetics
Unacceptabler
The
72
hour
mean
recovery
of
radioactivity
in
urine,
feces,
and
carcass
following
administration
of
0.5
mg/
kg
of
Phenyl­
U­
14C
CGA­
24705
was
43.1%,
47.0%,
and
7.4%
in
males
and
54.0%,
39.4%,
and
4.1%
in
females
respectively.
In
contrast,
both
sexes
excreted
more
of
the
label
in
the
feces
(
M:
F
59.7%:
53.4%)
than
in
the
urine
(
M:
F
29.4%:
39.8%)
during
the
same
period
following
administration
of
the
same
dose
of
Phenyl­
U­
14C
CGA
 
77102
(
the
S­
enantiomer)
(
MRID
44491401).

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
aRfD
or
cRfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approachassumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
EPA's
Health
Effects
Division's
Cancer
Assessment
Review
Committee
has
classified
metolachlor
as
a
Group
C
carcinogen
with
risk
quantitated
using
a
non­
linear
approach.
The
NOAEL
of
15
mg/
kg/
day
from
the
rat
combined
chronic
toxicity/
carcinogenicity
study
is
based
on
neoplastic
nodules/
hepatocellular
carcinomas
seen
at
the
highest
dose
tested
of
150
mg/
kg/
day.
The
Agency
notes
that
the
tumor
NOAEL
of
15
mg/
kg/
day
is
comparable
to
the
NOAEL
of
9.7
mg/
kg/
day
selected
for
establishing
the
chronic
reference
dose
for
metolachlor.
It
is
assumed
that
the
chronic
dietary
PAD
is
protective
for
cancer
dietary
risk.
Therefore,
a
separate
cancer
aggregate
risk
assessment
was
not
conducted,
and
cancer
DWLOC
values
were
not
calculated.
A
summary
of
the
toxicological
endpoints
for
SMetolachlor
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

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68,
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63
/
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April
2,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
METOLACHLOR/
S­
METOLACHLOR
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
all
population
subgroups)
NOAEL
=
300
mg/
kg/
day
UF
=
100x
FQPA
SF
=
1X
aPAD
=
3.0
mg/
kg/
day
Prenatal
developmental
toxicity
study
in
rats
with
metolachlor­
death,
clinical
signs
of
toxicity
(
clonic
and/
or
tonic
convulsions,
excessive
salivation,
urine­
stained
abdominal
fur
and/
or
excessive
salivation
and
decreased
body
weight
gain
Chronic
Dietary(
All
population
subgroups)
NOAEL=
9.7
mg/
kg/
day
UF
=
100x
FQPA
SF
=
1x
cPAD
=
0.1
mg/
kg/
day
Chronic
study
in
dogs
with
metolachlor­
endpoint
is
decreased
body
weight
in
females
Incidental
Oral,
Short­
term
(
one
to
30
days)
NOAEL
=
50
Target
MOE
=
100
Prenatal
developmental
toxicity
study
in
rats
with
metolachlor­
increased
incidence
of
clinical
signs,
decreased
body
weight/
body
weight
gain,
food
consumption,
and
food
efficiency
Incidental
Oral,
Intermediate
term
(
one
month
to
180
days)
NOAEL
=
8.8
Target
MOE
=
100
Subchronic
(
6
month)
toxicity
study
in
dogs
with
metolachlor­
decreased
body
weight
gain
Dermal,
Short­
and
Intermediate
Term
No
systemic
toxicity
was
seen
at
the
limit
dose
(
1,000
mg/
kg/
day)
following
dermal
applications
None
Hazard
was
not
identified
for
quantification
of
risk.
there
is
no
concern
for
developmental
toxicity
in
rats
or
rabbits.

Dermal,
Long­
Terma
(
greater
than
180
days)
Oral
NOAEL
=
9.7
Target
MOE
=
100
chronic
toxicity
study
in
dogs
with
metolachlor­
decreased
body
weight
gain
in
females
Inhalation,
Short­
Termb
Oral
NOAEL
=
50
Target
MOE
=
100
Prenatal
development
toxicity
study
in
rats
with
Smetolachlor
increased
incidence
of
clinical
signs,
decreased
body
weight/
body
weight
gain,
food
consumption,
and
food
efficiency
Inhalation,
Intermediate­
Termb
Oral
NOAEL
=
8.8
Target
MOE
=
100
subchronic
(
6
month)
toxicity
study
in
dogs
with
metolachlor­
decreased
body
weight
gain
Inhalation,
Long­
Termb
Oral
NOAEL
=
9.7
Target
MOE
=
100
chronic
toxicity
study
in
dogs
with
metolachlor­
decreased
body
weight
gain
in
females
Cancer
Classification:
Group
C,
possible
human
carcinogen
with
risk
quantitated
using
a
non­
linear
approach.

*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
retained
due
to
concerns
unique
to
the
FQPA.
a
Since
an
oral
NOAEL
was
selected,
a
dermal
absorption
factor
of
58%
should
be
used
in
route­
to­
route
extrapolation.
b
Since
an
oral
NOAEL
was
selected,
an
inhalation
factor
of
100%
should
be
used
in
route­
to­
route
extrapolation.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
for
metolachlor
currently
cover
residues
of
Smetolachlor
on
the
same
commodities
for
the
same
use
pattern
when
the
maximum
labeled
use
rate
of
Smetolachlor
is
approximately
35
percent
less
than
the
historical
use
rate
of
metolachlor.
Tolerances
have
been
established
(
40
CFR
180.368(
a))
for
the
combined
residues
of
metolachlor
and
Smetolachlor
in
or
on
a
variety
of
raw
agricultural
commodities.
Tolerances
for
residues
of
both
metolachlor
and
smetolachlor
in
or
on
raw
agricultural
commodities
include
the
combined
residues
of
(
free
and
bound)
metolachlor
and
its
metabolites,
determined
as
the
derivatives,
CGA
 
37913
and
CGA
 
47951,
each
expressed
as
parent
compound.
Permanent
tolerances
for
metolachlor/
S­
metolachlor
residues
have
been
established
on
various
plant
commodities
ranging
from
0.1
ppm
in/
on
numerous
commodities
to
30.0
ppm
in/
on
peanut
forage
and
hay
(
40
CFR
180.368(
a)).
Time­
limited
tolerances
associated
with
section
18
emergency
exemptions
have
been
established
for
metolachlor
residues
in/
on
grass
forage
and
hay,
spinach,
and
tomato
commodities
(
40
CFR
180.368(
b)).
Tolerances
associated
with
regional
registrations
have
also
been
established
for
metolachlor
residues
in/
on
dry
bulb
onions,
cabbage,
and
various
peppers
(
chili,
Cubanelle,
and
tabasco)
(
40
CFR
180.368(
c)).
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
S­
metolachlor
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
A
conservative
Tier
I
acute
dietary
exposure
assessment
was
conducted
for
all
labeled
metolachlor
and
S­
metolachlor
food
uses.
Inputs
for
this
assessment
included
tolerance­
level
residue
values
and
an
assumption
that
100%
of
all
labeled
crops
were
treated
with
metolachlor/
S­
metolachlor.
For
all
supported
registered
commodities,
the
acute
dietary
exposure
estimates
are
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Rules
and
Regulations
below
the
Agency's
level
of
concern
(<
100%
aPAD)
at
the
95th
exposure
percentile
for
the
general
U.
S.
population
and
all
population
subgroups.
The
acute
dietary
risk
estimate
for
the
highest
exposed
population
subgroup,
children
1
 
6
years
of
age,
is
<
1%
of
the
aPAD.
Acute
dietary
risk
estimates
are
not
of
concern.
Results
of
the
acute
dietary
risk
assessment
are
presented
in
Table
3
below.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
A
conservative
Tier
I
chronic
dietary
exposure
assessment
was
conducted
for
all
supported
metolachlor
and
Smetolachlor
food
uses.
For
all
supported
registered
commodities,
the
chronic
dietary
exposure
estimates
are
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
The
chronic
dietary
risk
estimate
for
the
highest
exposed
population
subgroup,
children
1
 
6
years
of
age,
is
4%
of
the
cPAD.
Chronic
dietary
risk
estimates
are
not
of
concern.
Results
of
the
chronic
dietary
risk
assessment
are
presented
in
Table
3
below.

TABLE
3.
 
SUMMARY
OF
DIETARY
EXPOSURE
ESTIMATES
FOR
METOLACHLOR
AND
S­
METOLACHLOR
Population
Subgroup
Acute
Dietary
Chronic
Dietary
Cancer
Risk
Dietary
Exposure
(
mg/
kg/
day)
%
aPAD
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.004111
<
1
0.001643
2
NA
All
Infants
(<
1
year
old)
0.006855
<
1
0.002280
2
N/
A
Children
1
 
2
years
old
0.008224
<
1
0.004025
4
NA
Children
3
 
5
years
old
0.006965
<
1
0.003510
4
NA
Children
6
 
12
years
old
0.005003
<
1
0.002412
2
NA
Youth
13
 
19
years
old
0.003309
<
1
0.001515
2
NA
Adults
20
 
49
years
old
0.002815
<
1
0.001263
1
NA
Females
13
 
49
years
old
0.002965
<
1
0.001349
1
NA
Adults
50+
years
old
0.002839
<
1
0.001226
1
NA
NA
=
not
applicable
The
Agency
notes
that
the
conservative
Tier
I
dietary
assessments
for
metolachlor
and
S­
metolachlor
could
be
refined
for
more
realistic
dietary
exposure
estimates
by
using
available
percent
crop
treated
estimates,
field
trial
and
monitoring
data,
and
processing
factors;
however,
the
estimated
dietary
risk
to
metolachlor
and
S­
metolachlor
is
not
of
concern
for
all
populations
in
both
the
acute
and
chronic
assessments.
Further
refinements
are
not
warranted
at
this
time.
2.
Dietary
exposure
from
drinking
water.
A
drinking
water
assessment
for
metolachlor
and
S­
metolachlor
involved
the
analysis
of
surface
and
ground
water
monitoring
data,
prospective
ground
water
study
data,
and
Tier
I
(
FIRST
and
screening
concentration
in
ground
water
(
SCI­
GROW))
and
Tier
II
(
pesticide
root
zone
modeling/
exposure
analysis
modeling
system
(
PRZM/
EXAMS))
modeling
results.
This
assessment
includes
concentrations
of
parent
metolachlor/
S­
metolachlor
and
the
degradates
metolachlor
ethanesulfonic
acid
(
ESA)
and
metolachlor
oxanilic
acid
(
OA).
Although
it
was
determined
by
the
Metabolism
Assessment
Review
Committee
that
the
ESA
and
OA
metabolites
appear
to
be
less
toxic
than
parent
metolachlor/
S­
metolachlor,
they
are
included
in
this
risk
assessment
since
they
were
found
in
greater
abundance
than
the
parent
in
water
monitoring
studies.
The
Agency
notes
that
a
key
assumption
of
the
drinking
water
assessment
is
that
reported
monitoring
data
represent
both
racemic
metolachlor
and
S­
metolachlor.
The
analytical
methods
for
surface
and
ground
water
monitoring
data
used
in
this
assessment
were
unable
to
distinguish
between
metolachlor
and
S­
metolachlor
at
the
time
monitoring
was
conducted.
However,
the
Agency
believes
that
the
fate
properties
of
racemic
metolachlor
and
S­
metolachlor
are
similar.
Therefore,
the
EECs
used
in
this
risk
assessment
are
representative
of
both
racemic
metolachlor
and
S­
metolachlor.
The
environmental
fate
data
base
is
complete
for
metolachlor.
Parent
metolachlor/
S­
metolachlor
appear
to
be
moderately
persistent
to
persistent,
and
range
from
mobile
to
highly
mobile
in
different
soils.
Metolachlor/
Smetolachlor
have
reportedly
been
detected
as
deep
as
the
36
to
48
inch
soil
layer
(
maximum
sampled
soil
depth)
in
some
studies.
Degradation
appears
to
be
dependent
on
microbially
mediated
and
abiotic
processes.
The
frequency
of
detection
of
metolachlor/
Smetolachlor
from
evaluated
monitoring
data
suggest
that
contamination
in
drinking
water
sources
may
be
widespread.
Environmental
fate
data
comparing
metolachlor
and
S­
metolachlor
indicate
that
both
are
expected
to
have
similar
degradation
pathways
and
rates
in
soil
and
water
environments,
and
both
are
expected
to
be
mobile
to
highly
mobile
in
soil
and
water
environments.
i.
EECs
for
parent
metolachlor/
Smetolachlor
No
single
surface
or
ground
water
monitoring
study
that
was
representative
of
the
entire
metolachlor/
S­
metolachlor
use
area
was
available
for
the
drinking
water
assessment.
As
a
result,
the
drinking
water
assessment
for
parent
metolachlor/
S­
metolachlor
is
based
primarily
on
monitoring
data
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Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
from
the
following
sources:
the
U.
S.
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
(
NAWQA)
database,
the
US
EPA
STORET
data
base,
the
Acetochlor
Registration
Partnership
(
ARP)
data
base,
and
two
USGS
Reservoir
Monitoring
studies.
The
acute
estimated
environmental
concentration
(
EEC)
of
77.6
parts
per
billion
(
ppb)
was
selected
from
the
NAWQA
database,
and
the
chronic
EEC
of
4.3
ppb
was
selected
from
the
maximum
annual
time
weighted
mean
from
the
NAWQA
data.
These
values
are
representative
of
the
estimated
concentration
of
parent
metolachlor/
Smetolachlor
in
monitored
ambient
surface
water,
and
are
supported
by
the
metolachlor
concentrations
from
the
National
Contaminant
Occurrence
Database
representing
analysis
of
treated
drinking
water,
as
well
as
from
model
predictions
using
PRZM/
EXAMS.
Acute
and
chronic
concentrations
of
parent
metolachlor/
S­
metolachlor
in
ground
water
were
modeled
using
SCIGROW
SCI­
GROW
estimates
the
highend
ground
water
concentrations
of
pesticides
likely
to
occur
when
the
pesticide
is
used
at
the
maximum
allowable
rate
in
areas
with
ground
water
vulnerable
to
contamination.
Estimates
were
based
on
two
applications
to
corn/
turf
for
a
total
of
4
lbs
ai/
acre
(
the
maximum
application
rate).
In
comparison
to
the
SCI­
GROW
estimate
of
5.5
ppb
in
shallow
ground
water,
the
Iowa
NAWQA
data
have
a
maximum
concentration
of
15.4
ppb.
However,
it
should
be
noted
that
the
second
highest
concentration
of
parent
metolachlor/
S­
metolachlor
in
the
Iowa
NAWQA
data
is
1.7
ppb.
Since
the
detections
in
the
National
NAWQA
data
(
32.8
ppb)
and
in
the
Iowa
NAWQA
data
(
15.4
ppb)
were
single
values
outside
the
range
of
the
rest
of
the
data,
EPA
determined
that
use
of
SCI­
GROW
was
more
appropriate
for
the
risk
assessment.
Additionally,
recent
data
collected
by
the
Suffolk
County,
New
York
Department
of
Health
Services,
Bureau
of
Groundwater
Resources
indicate
that
both
metolachlor
and
S­
metolachlor,
and
its
degradates,
have
been
detected
in
ground
water.
In
data
collected
between
1997
and
2001,
metolachlor/
Smetolachlor
was
detected
in
60
well
samples
with
a
maximum
concentration
of
83
ppb.
No
information
was
available
on
frequency
of
detection
and
only
summary
statistics
were
provided
on
these
data;
therefore,
these
data
were
not
used
quantitatively
in
the
risk
assessment.
However,
these
data
suggest
that
the
SCI­
GROW
estimates
for
metolachlor/
S­
metolachlor
are
not
overestimating
the
potential
impact
of
metolachlor/
S­
metolachlor
use
on
ground
water.
The
SCI­
GROW
estimate
of
5.5
ppb
in
ground
water
is
appropriate
for
risk
assessment
purposes.
ii.
EECs
for
metolachlor
ESA
and
OA
degradates.
Only
two
small
data
sets
were
available
on
the
ESA
and
OA
degradates
from
the
Iowa
and
Illinois
NAWQA
data.
In
the
absence
of
more
robust
monitoring
data
for
the
degradates,
upper­
bound
Tier
I
estimates
for
ESA
and
OA
based
on
FIRST
and
SCI­
GROW
modeling
were
used
to
calculate
EECs
for
the
degradates.
The
modeling
used
conservative
assumptions
of
selected
fate
parameters
(
aerobic
soil
metabolism
rate
constant
and
soil
partitioning
coefficient)
as
well
as
the
maximum
application
rate
of
4
lbs
ai/
acre
on
turf/
corn.
Acute
and
chronic
estimates
of
metolachlor
ESA
in
surface
water
(
based
on
FIRST
modeling)
are
31.9
ppb
and
22.8
ppb,
respectively.
Acute
and
chronic
estimates
of
metolachlor
OA
in
surface
water
are
91.4
ppb
and
65.1
ppb,
respectively.
The
Agency
notes
that
the
application
rate
used
for
metolachlor
ESA
and
OA
in
the
model
runs
was
estimated
by
converting
maximum
label
rates
for
each
use
by
the
maximum
percentage
of
degradate
found
in
fate
studies.
In
addition,
each
application
rate
was
corrected
for
molecular
weight
differences
of
each
degradate.
However,
a
statistically
significant
relationship
between
parent
metolachlor
and
degradates
could
not
be
established;
therefore,
the
amount
of
degradate
is
an
uncertainty
in
this
assessment.
This
uncertainty
was
addressed
in
the
screening
level
assessments
using
FIRST
and
SCI­
GROW
with
conservative
assumptions
for
model
inputs.
The
model
predictions
for
ESA
and
OA
compare
with
the
limited
monitoring
data
available.
The
screening
level
predictions
were
higher
than
the
available
data
suggesting
that
the
predictions
were
likely
upper
bound
and
conservative.
EPA
determined
that
these
upper
bound
predictions
will
not
underestimate
the
potential
exposures
for
infants
and
children
from
the
use
of
metolachlor.
Acute
and
chronic
estimates
of
metolachlor
ESA
in
ground
water
(
based
on
SCI­
GROW
modeling,
turf/
corn
scenario)
are
not
expected
to
exceed
65.8
ppb.
This
value
is
considered
representative
of
both
peak
and
longterm
average
concentrations
because
of
the
inherent
transport
nature
of
ground
water
(
generally
slow
movement
from
the
source
of
contamination
both
laterally
and
horizontally).
Acute
and
chronic
estimates
of
metolachlor
OA
in
ground
water
(
also
based
on
the
turf
/
corn
scenario)
are
not
expected
to
exceed
31.7
ppb.
The
Agency
notes
that
these
values
exceed
those
detected
in
the
Iowa
NAWQA
study
(
63.7
ppb
for
metolachlor
ESA
and
4.4
ppb
for
metolachlor
OA),
and
also
exceed
those
values
detected
in
two
PGW
studies
(
metolachlor
ESA
was
detected
at
a
maximum
concentration
of
24
ppb
while
metolachlor
OA
was
detected
at
a
maximum
concentration
of
15.6
ppb).
In
addition,
recent
data
collected
by
the
Suffolk
County,
New
York
Department
of
Health
Services,
Bureau
of
Groundwater
Resources
indicate
that
both
metolachlor
and
S­
metolachlor,
and
its
degradates,
have
been
detected
in
ground
water.
In
data
collected
between
1997
and
2001,
metolachlor
ESA
was
detected
in
296
well
samples
with
a
maximum
concentration
of
39.7
ppb,
while
metolachlor
OA
was
detected
in
228
wells
with
a
maximum
concentration
of
49.6
ppb.
No
information
was
available
on
frequency
of
detection
and
only
summary
statistics
were
provided
on
these
data;
therefore,
these
data
were
not
used
quantitatively
in
the
risk
assessment.
iii.
Drinking
water
levels
of
comparison
(
DWLOCs).
In
the
absence
of
chemical­
specific
monitoring
data,
the
Agency
uses
drinking
water
levels
of
comparison
to
calculate
aggregate
risk.
A
drinking
water
level
of
comparison,
or
a
DWLOC,
is
a
theoretical
upper
limit
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
drinking
water,
and
through
residential
uses.
In
other
words,
the
DWLOC
value
represents
the
maximum
theoretical
exposure
a
person
may
have
to
pesticide
residues
through
drinking
water,
after
their
exposure
to
the
pesticide's
residues
through
food
and
residential
exposure
have
been
taken
into
consideration.
The
Office
of
Pesticide
Programs
uses
DWLOCs
internally
in
the
risk
assessment
process
as
a
surrogate
measure
of
potential
exposure
associated
with
pesticide
exposure
through
drinking
water.
DWLOC
values
are
not
regulatory
standards
for
drinking
water;
however,
they
do
have
an
indirect
regulatory
impact
through
aggregate
exposure
and
risk
assessments.
DWLOCs
are
calculated
for
each
type
of
risk
assessment
as
appropriate
(
acute,
short­
term,
intermediate­
term,
chronic,
and
cancer)
and
compared
to
the
appropriate
estimated
concentration
of
a
pesticide
in
surface
and
ground
water.
If
the
DWLOC
is
greater
than
the
estimated
surface
and
ground
water
concentration,
(
i.
e.,
if
the
DWLOC
>
EEC),
the
Agency
concludes
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reasonable
certainty
there
is
no
drinking
water
risk
of
concern.
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).
SMetolachlor
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
lawn,
turf
(
including
sod
farms),
golf
courses,
sports
fields,
and
ornamental
gardens.
Although
not
labeled
as
a
restricted­
use
pesticide,
the
label
indicates
that
it
is
not
intended
for
use
by
homeowners
but
only
for
use
by
professional
lawn
care
applicators.
On
this
basis,
a
residential
handler
is
not
expected
to
be
exposed
to
residues
of
Smetolachlor
Therefore,
a
residential
handler
assessment
was
not
conducted.
There
is
potential
for
postapplication
exposure
to
adults
and
children
resulting
from
the
use
of
S­
metolachlor
on
residential
lawns.
Although
the
use
sites
for
S­
metolachlor
vary
from
golf
courses
to
ornamental
gardens,
the
residential
lawn
scenario
represents
what
the
Agency
considers
the
likely
upper­
end
of
possible
exposure.
Postapplication
exposures
from
various
activities
following
lawn
treatment
are
considered
to
be
the
most
common
and
significant
in
residential
settings.
Postapplication
exposure
is
considered
to
be
short­
term
(
1
to
30
days
of
exposure)
only,
based
on
a
label
specification
of
a
6
 
week
interval
before
the
re­
application
of
S­
metolachlor.
A
short­
term
dermal
endpoint
was
not
selected,
since
no
systemic
toxicity
was
seen
at
the
limit
dose
of
1,000
mg/
kg/
day;
therefore,
a
dermal
risk
assessment
was
not
conducted
and
dermal
exposures
are
assumed
to
be
minimal.
Postapplication
inhalation
exposure
is
also
expected
to
be
minimal
since
Smetolachlor
is
only
applied
in
an
outdoor
setting,
the
vapor
pressure
is
low
(
2.8
x
10­
5
mm
Hg
at
25
°
C),
and
the
label
specifies
that
residents
should
not
re­
enter
treated
areas
until
after
sprays
have
dried.
The
following
postapplication
incidental
oral
scenarios
following
application
to
lawns
and
turf
have
been
identified:
(
1)
Short­
term
oral
exposure
to
toddlers
and
children
following
hand­
to­
mouth
exposure;
(
2)
short­
term
oral
exposure
to
toddlers
and
children
following
object­
to­
mouth
exposure;
and
(
3)
short­
term
oral
exposure
to
toddlers
and
children
following
soil
ingestion.
The
term
``
incidental''
is
used
to
distinguish
the
inadvertent
oral
exposure
of
small
children
from
exposure
that
may
be
expected
from
treated
foods
or
residues
in
drinking
water.
Since
the
FQPA
safety
factor
for
the
protection
of
children
and
infants
was
reduced
to
1X,
a
target
MOE
value
of
100
has
been
identified
for
residential
assessments.
MOE
values
greater
than
100
are
not
considered
to
be
of
concern
to
the
Agency.
MOE
estimates
are
based
on
the
dose
level
of
50
mg/
kg/
day
established
for
short­
term
oral
risk
assessment.
The
exposure
and
risk
estimates
for
the
three
residential
exposure
scenarios
are
assessed
for
the
day
of
application
(
day
``
0'')
since
children
will
likely
contact
the
lawn
immediately
following
application.
The
following
estimates/
assumptions
were
used
in
the
risk
assessment:
(
1)
A
single
application
at
the
maximum
label
rate
of
2.47
lb
ai/
acre
for
S­
metolachlor,
(
2)
exposure
duration
for
children
is
assumed
to
be
2
hours
per
day,
(
3)
the
exposed
child's
weight
is
15
kg
(
33
pounds),
and
(
4)
turf
transferable
residue
(
TTR)
value
of
5%,
and
objectto
mouth
residue
value
of
20%
of
the
application
rate
assumed.
The
exposure
estimates
for
the
three
postapplication
scenarios
(
object­
tomouth
hand­
to­
mouth,
and
incidental
soil
ingestion)
were
combined
to
represent
the
possible
(
if
not
likely)
high­
end
oral
exposure
resulting
from
lawn
(
or
similar
use).
Combined
postapplication
oral
risk
estimates
for
Smetolachlor
are
not
of
concern.
The
following
Table
4
summarizes
the
results
of
the
residential
postapplication
assessment:

TABLE
4.
 
SUMMARY
OF
RESIDENTIAL
POSTAPPLICATION
MOE
VALUES
Exposure
Scenarioa
S­
Metolachlorb
Oral
Dose
(
mg/
kg/
day)
Oral
Short­
term
MOEc
Object­
to­
mouth
S­
metolachlor
0.0092
5,400
Hand­
to­
mouth
S­
metolachlor
0.037
1,400
Soil
ingestion
S­
metolachlor
0.00012
400,000
Combined
exposure
S­
metolachlor
0.046
1,100
a
Exposure
scenario
represents
oral
exposure
of
children,
with
an
assumed
body
weight
of
15
kg.
bS­
metolachlor
application
rate
is
2.47
lb
ai/
acre.
c
Short­
term
oral
MOE
=
NOAEL/
Dose,
where
short­
term
oral
NOAEL
=
50
mg/
kg/
day.

S­
metolachlor
may
be
used
on
sports
and
recreational
fields,
as
well
as
golf
courses.
However,
the
Agency
believes
that
children's
exposure
to
residues
of
S­
metolachlor
remaining
on
residential
lawns
after
treatment
represents
the
likely
upper­
end
of
exposure.
Furthermore,
since
dermal
and
inhalation
risks
are
not
of
concern,
and
oral
exposures
from
sports
and
recreational
fields,
as
well
as
golf
courses,
are
expected
to
be
minimal,
risks
for
these
other
non­
occupational
settings
are
expected
to
be
insignificant.
The
Agency
has
conducted
a
direct
exposure
assessment
for
the
use
of
Smetolachlor
on
lawns,
and
determined
that
there
is
no
risk
of
concern
from
this
use.
No
additional
risk
from
Smetolachlor
is
expected
from
spray
drift.
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.''
The
chloroacetanilide
pesticides
represent
a
class
of
food
use
pesticides
that
have
been
given
high
priority
by
the
Agency
for
the
reassessment
of
tolerances
in
accordance
with
the
mandates
of
FQPA.
The
group
of
chloroacetanilide
pesticides
covered
by
this
review
consists
of
acetochlor,
alachlor,
butachlor,
metolachlor
and
propachlor.
Various
members
of
this
group
of
chloroacetanilide
pesticides
have
been
shown
to
result
in
several
different
types
of
tumor
responses
in
laboratory
animals
(
e.
g.,
nasal,
thyroid,
liver,
and
stomach
tumors).
Therefore,
as
part
of
the
reassessment,
EPA
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scientists
considered
several
different
potential
common
mechanism
of
toxicity
groupings
for
these
chemicals.
In
reviewing
this
issue,
EPA
scientists
were
guided
by
several
relevant
Agency
science
policies,
including
Guidance
for
Identifying
Pesticide
Chemicals
and
Other
Substances
that
Have
a
Common
Mechanism
of
Toxicity.
Additionally,
on
March
19,
1997,
the
Agency
presented
to
the
FIFRA
Scientific
Advisory
Panel
(
SAP)
a
draft
case
study
illustrating
the
application
of
the
Common
Mechanism
Guidance
to
the
grouping
of
chloroacetanilide
pesticides
based
on
a
common
mechanism
of
toxicity.
The
SAP
agreed
with
the
Agency's
conclusion
that
there
is
sufficient
evidence
to
support
the
grouping
of
certain
chloroacetanilides
that
cause
nasal
turbinate
tumors
by
a
common
mechanism
of
toxicity.
Upon
consideration
of
the
SAP
comments,
EPA's
own
reviews
and
the
data
underlying
these
reviews,
as
well
as
additional
information
received
by
the
Agency
from
registrants
or
presented
in
the
open
literature
since
the
1997
draft
document,
EPA
has
revised
its
science
document
discussing
the
potential
grouping
of
chloroacetanilide
pesticides,
or
a
subgroup
of
them,
based
on
a
common
mechanism
of
toxicity.
In
the
revised
document
entitled
``
The
Grouping
of
a
Series
of
Chloroacetanilide
Pesticides
Based
on
a
Common
Mechanism
of
Toxicity,''
EPA
has
concluded
that
only
some
of
the
pesticides
that
comprise
the
class
of
chloroacetanilides
should
be
designated
as
a
``
Common
Mechanism
Group''
based
on
the
development
of
nasal
turbinate
tumors
by
metabolism
to
a
highly,
tissue
reactive
moiety,
i.
e.,
quinoneimine.
Thus,
only
acetochlor,
alachlor,
and
butachlor
should
be
grouped
based
on
a
common
mechanism
of
toxicity
for
nasal
turbinate
tumors.
Although
metolachlor
does
distribute
to
the
nasal
turbinates,
and
might
produce
a
quinoneimine,
it
is
not
apparent
from
currently
available
data
that
it
shares
the
same
target
site
in
the
nasal
tissue
as
acetochlor,
alachlor
and
butachlor.
Although
propachlor
does
produce
a
precursor
of
a
quinoneimine,
the
available
data
do
not
support
its
tumorigenicity
to
the
nasal
turbinates.
In
conclusion,
it
is
the
Agency's
position,
that
only
some
chloroacetanilides,
namely
acetochlor,
alachlor,
and
butachlor
should
be
considered
as
a
``
Common
Mechanism
Group''
due
to
their
ability
to
cause
nasal
turbinate
tumors.
For
purposes
of
a
cumulative
risk
assessment
as
a
part
of
the
tolerance
reassessment
process
for
acetochlor,
alachlor,
and
butachlor,
these
three
pesticides
will
be
considered
as
a
Common
Mechanism
Group.
Following
the
initiation
of
a
cumulative
risk
assessment,
further
analyses
of
new
or
existing
data
may
occur
which
could
impact
the
Agency's
evaluation
of
specific
members
of
this
group
or
the
group
as
a
whole.

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.
Prenatal
developmental
studies
in
the
rat
and
rabbit
revealed
no
evidence
of
a
qualitative
or
quantitative
susceptibility
in
fetal
animals.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
S­
metolchlor
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
removed.
The
FQPA
Safety
Factor
Committee
met
on
November
5,
2001
to
evaluate
the
hazard
and
exposure
data
for
metolachlor
and
S­
metolachlor,
and
recommended
that
the
FQPA
Safety
Factor
for
the
protection
of
infants
and
children
be
reduced
to
1x
for
the
following
reasons:
(
1)
The
toxicology
database
is
complete
for
the
FQPA
assessment;
(
2)
there
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
metolachlor
in
the
available
toxicity
data;
(
3)
a
developmental
neurotoxicity
study
is
not
required
for
metolachlor;
and
(
4)
the
dietary
(
food
and
drinking
water)
and
non­
dietary
exposure
(
residential)
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children
from
the
use
of
metolachlor.

E.
Aggregate
Risks
and
Determination
of
Safety
1.
Acute
risk.
An
acute
aggregate
risk
assessment
addresses
potential
exposure
from
combined
residues
of
metolachlor/
S­
metolachlor
on
food
and
in
drinking
water
(
both
surface
and
ground
water).
Potential
residential
exposures
are
not
incorporated
into
an
acute
aggregate
risk
assessment.
As
shown
in
Table
5
below,
the
EECs
are
below
the
Agency's
backcalculated
DWLOC
values
for
the
parent
compound,
the
ESA
degradate,
and
the
OA
degradate.
The
combined
value
of
the
parent
plus
the
degradates
is
also
below
the
acute
DWLOC
value.
The
Agency
concludes
that
acute
aggregate
risk
estimates
are
not
of
concern
for
any
population
subgroup.

TABLE
5.
 
ACUTE
DWLOC
CALCULATIONS
FOR
METOLACHLOR/
S­
METOLACHLOR
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)*
Ground
Water
EEC
(
ppb)*
Acute
DWLOC
(
ppb)

U.
S.
Population
3.0
1
200.9
103
1.0
x
105
Females
13
 
50
3.0
1
200.9
103
9.0
x
104
Children
1
 
6
3.0
1
200.9
103
3.0
x
104
Males
13
 
19
3.0
1
200.9
103
9.0
x
104
*
Represents
the
combined
value
of
parent
plus
the
ESA
and
OA
degradates.

2.
Chronic
risk.
A
chronic
aggregate
risk
assessment
considers
chronic
exposure
from
food,
drinking
water,
and
non­
occupational
(
residential)
pathways
of
exposure.
For
metolachlor
and
Smetolachlor
there
are
no
chronic
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2,
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Rules
and
Regulations
(
greater
than
180
days
of
exposure)
nonoccupational
exposure
scenarios.
Therefore,
the
chronic
aggregate
risk
assessment
will
consider
exposure
from
food
and
drinking
water
only.
The
EECs
for
ground
water
residues
of
the
parent
compound
(
5.5),
the
ESA
degradate
(
65.8),
and
the
OA
degradate
(
31.7)
are
below
the
Agency's
chronic
DWLOC
values
for
all
population
subgroups.
The
combined
value
of
the
parent
plus
degradates
(
103)
is
also
below
the
chronic
DWLOC
value.
The
EECs
for
surface
water
residues
of
the
parent
compound
(
4.3),
the
ESA
degradate
(
22.8),
and
the
OA
degradate
(
65.1)
are
below
the
Agency's
chronic
DWLOC
values
for
all
population
subgroups.
The
combined
value
of
the
parent
plus
degradates
(
92.2)
is
also
below
the
chronic
DWLOC
value.
The
Agency
concludes
that
chronic
aggregate
risks
are
not
of
concern.

TABLE
6.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
METOLACHLOR/
S­
METOLACHLOR
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)*
Ground
Water
EEC
(
ppb)*
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.1
2
92.2
103
3442.50
Females
13
 
50
0.1
1
92.2
103
2962.11
Children
1
 
6
0.1
4
92.2
103
959.75
Males
13
 
19
0.1
2
92.2
103
2954.55
*
Represents
the
combined
value
of
parent
plus
the
ESA
and
OA
degradates.

3.
Short­
term
risk.
A
short­
term
aggregate
risk
assessment
considers
potential
exposure
from
food,
drinking
water,
and
short­
term,
non­
occupational
(
residential)
pathways
of
exposure.
For
S­
metolachlor,
potential
short­
term,
non­
occupational
risk
scenarios
include
oral
exposure
of
children
to
treated
lawns.
In
this
aggregate
short­
term
risk
assessment,
exposure
from
food,
drinking
water,
and
residential
lawns
(
S­
metolachlor
use
only)
has
been
considered.
Since
only
children
have
the
potential
for
non­
occupational,
short­
term
risk,
they
are
the
only
population
subgroup
included
below.
Short­
term
DWLOC
values
have
been
calculated
for
S­
metolachlor
only,
since
Syngenta
no
longer
holds
any
racemic
metolachlor
residential
end­
use
products.
EECs
for
the
parent
compound,
the
ESA
degradate,
and
the
OA
degradate
are
below
the
short­
term
S­
metolachlor
DWLOC
value
for
the
population
children
(
1
to
6
years
old).
The
combined
value
of
the
parent
plus
the
degradates
is
also
below
the
shortterm
S­
metolachlor
DWLOC
value.
The
Agency
concludes
that
short­
term
aggregate
risks
from
S­
metolachlor
are
not
of
concern.
The
target
MOE
is
100,
based
on
the
100x
uncertainty
factor,
and
the
1x
FQPA
safety
factor.
This
MOE
is
not
exceeded
by
the
MOE
for
food
which
is
1.6
X
104
(
short­
term
oral
NOAEL
(
50
mg/
kg/
day)/
chronic
dietary
exposure
of
children
(
0.003171
mg/
kg/
day);
MOE
for
oral
which
is
1,100
(
short­
term
oral
NOAEL
(
50
mg/
kg/
day)/
combined
hand­
to­
mouth,
object­
tomouth
and
soil
ingestion
oral
exposure
(
0.046
mg/
kg/
day
S­
metolachlor));
aggregate
MOE
for
food
and
residential
which
is
1,000
(
1
÷
(
1
÷
MOE
food)
+
(
1
÷
MOE
oral));
or
allowable
water
exposure
which
is
0.45
mg/
kg/
day
(
1
÷
(
1
÷
Target
Aggregate
MOE)
­
(
1
÷
Aggregate
MOE
(
food
and
residential)).
The
DWLOC
is
4,000
ppb.
The
EEC
for
ground
water
is
103.3
ppb
(
parent
5.5,
ESA
metabolite
65.8
ppb
and
OA
metabolite
32
ppb).
The
EEC
for
surface
water
is
92.2
ppb
(
parent
4.3,
ESA
metabolite
22.8
ppb
and
OA
metabolite
65.1
ppb).
For
informational
purposes,
it
is
noted
that
the
EEC
values
for
the
parent
compound,
ESA
degradate,
and
the
OA
degradate
are
below
the
metolachlor
short­
term
DWLOC
value
for
children.
The
combined
value
of
the
parent
plus
the
degradates
is
also
below
the
metolachlor
short­
term
DWLOC
value.

TABLE
7.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
METOLACHLOR/
S­
METOLACHLOR
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

Children
1
to
6
1,000
100
92.2
103.3
4,000
4.
Intermediate­
term
risk.
An
intermediate­
term
aggregate
risk
assessment
considers
potential
exposure
from
food,
drinking
water,
and
nonoccupational
(
residential)
pathways
of
exposure.
However,
for
metolachlor/
Smetolachlor
no
intermediate­
term
nonoccupational
exposure
scenarios
(
greater
than
30
days
exposure)
are
expected
to
occur.
Therefore,
intermediate­
term
DWLOC
values
were
not
calculated
and
an
intermediate­
term
aggregate
risk
assessment
is
not
required.
5.
Aggregate
cancer
risk
for
U.
S.
population.
An
aggregate
cancer
risk
assessment
considers
potential
carcinogenic
exposure
from
food,
drinking
water,
and
non­
occupational
(
residential)
pathways
of
exposure.
However,
as
noted
under
Unit
III.
B.,
Toxicological
Endpoints,
the
NOAEL
that
was
established
based
on
tumors
in
the
rat
(
15
mg/
kg/
day,
seen
at
the
highest
dose
tested
of
150
mg/
kg/
day)
is
comparable
to
the
NOAEL
of
9.7
mg/
kg/
day
selected
for
establishing
the
chronic
reference
dose
for
metolachlor.
It
is
assumed
that
the
chronic
dietary
endpoint
is
protective
for
cancer
dietary
exposure.
Therefore,
a
separate
cancer
aggregate
risk
assessment
was
not
conducted,
and
cancer
DWLOC
values
were
not
calculated.
6.
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
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Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
from
aggregate
exposure
to
metolachlor/
S­
metolachlor
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
Pesticide
Analytical
Manual
(
PAM)
Vol.
II,
lists
a
gas
chromatography/
nitrogen
phosphorous
detection
(
GC/
NPD)
method
(
Method
I)
for
determining
residues
in/
on
plants
and
a
gas
chromatography/
mass
spectrometry
detection
(
MSD)
method
(
Method
II)
for
determining
residues
in
livestock
commodities.
These
methods
determine
residues
of
metolachlor
and
its
metabolites
as
either
CGA
 
37913
or
CGA
 
49751
following
acid
hydrolysis.
Residue
data
from
the
most
recent
field
trials
and
processing
studies
were
obtained
using
an
adequate
GC/
NPD
method
(
AG
 
612),
which
is
a
modification
of
Method
I.
Adequate
data
are
available
on
the
recovery
of
metolachlor
through
Multi­
residue
Method
Testing
Protocols.
The
FDA
PESTDATA
database
indicates
that
metolachlor
is
completely
recovered
through
Method
302,
PAM
Vol.
I
(
3rd
ed.,
revised
10/
97).

B.
International
Residue
Limits
No
maximum
residue
limits
(
MRLs)
for
either
metolachlor
or
S­
metolachlor
have
been
established
or
proposed
by
Codex,
Canada,
or
Mexico
for
any
agricultural
commodity;
therefore,
no
compatibility
questions
exist
with
respect
to
U.
S.
tolerances.

C.
Conditions
The
need
for
a
28
 
day
inhalation
study
has
been
identified
for
both
metolachlor
and
S­
metolachlor.
Submission
of
this
study
would
allow
the
Agency
to
improve
characterization
regarding
the
concern
for
toxicity
via
the
inhalation
route
of
exposure
following
application
of
metolachlor/
Smetolachlor
on
multiple
days
in
a
commercial
setting.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
combined
residues
or
residues
of
Smetolachlor
Acetamid,
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)­,
(
S)
and
its
metabolites,
determined
as
the
derivatives,
2­(
2­
ethyl­
6­
methylphenyl)
amino­
1­
propanol
and
4­(
2­
ethyl­
6­
methylphenyl)­
2­
hydroxy­
5­
methyl­
3­
morpholinone,
each
expressed
as
the
parent
compound
S­
metolachlor
in
or
on
the
raw
agricultural
commodities
each
expressed
as
the
parent
compound
in
or
on
the
raw
agricultural
commodities
grass
forage
at
10.0
ppm,
grass
hay
at
0.02
ppm,
spinach
at
0.5
ppm,
sugar
beet
at
0.5
ppm,
sugar
beet
molasses
at
3.0
ppm,
sugar
beet
tops
at
15.0
ppm,
sunflower
at
0.5
ppm,
sunflower
meal
at
1.0
ppm,
and
tomato
at
0.1
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
 
2003
 
0046
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
June
2,
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
 
2003
 
0046,
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.

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and
Regulations
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
and
Executive
Order
Reviews
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.
Congressional
Review
Act
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:
March
25,
2003.
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
180.368
is
amended
in
paragraph
(
a)
by
designating
the
text
following
the
paragraph
heading
``
General
as
paragraph
(
a)(
1)
and
by
adding
new
paragraph
(
a)(
2)
to
read
as
follows:

§
180.368
Metholachlor;
tolerances
for
residues.

(
a)
General.
(
1)
*
*
*
(
2)
Tolerances
are
established
for
combined
residues
of
the
herbicide
Smetolachlor
acetamid,
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)­,
(
S)
and
its
metabolites,
determined
as
the
derivatives,
2­(
2­
ethyl­
6­
methylphenyl)
amino­
1­
propanol
and
4­(
2­
ethyl­
6­
methylphenyl)­
2­
hydroxy­
5­
methyl­
3­
morpholinone,
each
expressed
as
the
parent
compound
S­
metolachlor
in
or
on
the
following
raw
agricultural
commodities:

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Regulations
Commodity
Parts
per
million
Beet,
sugar,
molasses
..............
2.0
Beet,
sugar,
roots
.....................
0.5
Beet,
sugar,
tops
......................
15.0
Grass,
forage
............................
10.0
Grass,
hay
................................
0.2
Spinach
.....................................
0.5
Sunflower,
seed
........................
0.5
Sunflower,
meal
........................
1.0
Tomato
......................................
0.1
*
*
*
*
*
[
FR
Doc.
03
 
7800
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0328;
FRL
 
7286
 
9]

Bacillus
pumilus
GB
34;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
pumilus
GB
34
when
used
as
a
seed
treatment
in
or
on
soybeans
and
soybeans
after
harvest.
Gustafson
LLC
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
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Bacillus
pumilus
GB
34.

DATES:
This
regulation
is
effective
April
2,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0328,
must
be
received
on
or
before
June
2,
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
IX.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Anne
Ball,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8717;
e­
mail
address:
ball.
anne@
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),
e.
g.,
crop
production
 
Industry
(
NAICS
112),
e.
g.,
animal
production
 
Industry
(
NAICS
311),
e.
g.,
food
manufacturing
 
Industry
(
NAICS
32532,
e.
g.,
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
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
 
0328.
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.
Once
in
the
system,
select
``
search''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
December
31,
2001
(
66
FR
67522)
(
FRL
 
6813
 
8),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a(
e),
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
1F6344)
by
Gustafson
LLC,
1400
Preston
Road,
Suite
400,
Plano,
TX
75093.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Gustafson
LLC.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
B.
Pumilus
GB
34.

III.
Risk
Assessment
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
tolerance
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''

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