Document ID: EPA-HQ-OPP-2002-0331-0001
Agency: epa
Document Type: Rule
Title: S-Metolachlor; Pesticide Tolerances for Emergency Exemptions
Posted Date: 2003-01-03T05:00Z

274
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0331;
FRL
 
7283
 
2]

S­
metolachlor;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
time­
limited
tolerance
for
the
combined
residues
(
free
and
bound)
of
the
herbicide
s­
metolachlor
[(
S)­
2­
chloro­
N­
(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)
acetamide],
its
Renantiomer
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
sweet
potatoes.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
the
pesticide
on
sweet
potatoes.
This
regulation
establishes
a
maximum
permissible
level
for
residues
of
smetolachlor
in
this
food
commodity.
The
tolerance
will
expire
and
is
revoked
on
December
31,
2004.
Although
the
exemption
was
granted
for
the
active
ingredient
s­
metolachlor
and
the
timelimited
tolerance
is
being
set
for
smetolachlor
the
Agency
has
determined
that
residues
of
concern
for
smetolachlor
are
the
same
as
those
for
metolachlor,
and
therefore,
the
tolerance
is
being
included
under
40
CFR
180.368
but
under
its
own
section
in
paragraph
(
b).
Metabolites
of
metolachlor
are
assumed
to
be
toxicologically
equivalent
to
parent
metolachlor.
The
Agency
has
determined
that
the
residues
of
concern
for
plant
and
animal
commodities
are
metolachlor
and
its
metabolites,
determined
as
the
derivatives
CGA­
37913
and
CGA­
49751.
DATES:
This
regulation
is
effective
January
3,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0331,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Andrew
Ertman,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:(
703)
308
 
9367;
e­
mail
address:
sec­
18­
mailbox@
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
a
federal
or
state
government
agency
involved
in
administration
of
environmental
quality
programs
(
i.
e.,
Departments
of
Agriculture,
Environment,
etc).
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Federal
or
State
Government
Entity,
(
NAICS
9241),
Departments
of
Agriculture,
Environment,
etc.
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
 
0331.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml__
00/
Title__
40/
40cfr180_(_
00.
html,
a
beta
site
currently
under
development.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408
(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
is
establishing
a
tolerance
for
the
combined
residues
(
free
and
bound)
of
the
herbicide
s­
metolachlor
[(
S)­
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)
acetamide],
its
R­
enantiomer
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
sweet
potatoes
at
0.2
parts
per
million
(
ppm).
This
tolerance
will
expire
and
is
revoked
on
December
31,
2004.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerance
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
of
the
FFDCA
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.

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Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
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.
.
.
.''
Section
18
of
the
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
``
emergency
conditions
exist
which
require
such
exemption.''
This
provision
was
not
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
EPA
has
established
regulations
governing
such
emergency
exemptions
in
40
CFR
part
166.

III.
Emergency
Exemption
for
Smetolachlor
on
Sweet
Potatoes
and
FFDCA
Tolerances
The
States
of
Louisiana
and
Mississippi
requested
the
use
of
smetolachlor
on
sweet
potatoes
to
control
sedges
due
to
an
increased
pressure
from
these
weed
species
and
a
lack
of
effective
registered
alternatives.
EPA
has
authorized
under
FIFRA
section
18
the
use
of
s­
metolachlor
on
sweet
potatoes
for
control
of
sedges
in
Louisiana
and
Mississippi.
After
having
reviewed
the
submission,
EPA
concurs
that
emergency
conditions
exist
for
these
States.
As
part
of
its
assessment
of
this
emergency
exemption,
EPA
assessed
the
potential
risks
presented
by
residues
of
s­
metolachlor
in
or
on
sweet
potatoes.
In
doing
so,
EPA
considered
the
safety
standard
in
section
408(
b)(
2)
of
the
FFDCA,
and
EPA
decided
that
the
necessary
tolerance
under
section
408(
l)(
6)
of
the
FFDCA
would
be
consistent
with
the
safety
standard
and
with
FIFRA
section
18.
Consistent
with
the
need
to
move
quickly
on
the
emergency
exemption
in
order
to
address
an
urgent
non­
routine
situation
and
to
ensure
that
the
resulting
food
is
safe
and
lawful,
EPA
is
issuing
this
tolerance
without
notice
and
opportunity
for
public
comment
as
provided
in
section
408(
l)(
6)
of
the
FFDCA.
Although
this
tolerance
will
expire
and
is
revoked
on
December
31,
2004,
under
section
408(
l)(
5)
of
the
FFDCA,
residues
of
the
pesticide
not
in
excess
of
the
amounts
specified
in
the
tolerance
remaining
in
or
on
sweet
potatoes
after
that
date
will
not
be
unlawful,
provided
the
pesticide
is
applied
in
a
manner
that
was
lawful
under
FIFRA,
and
the
residues
do
not
exceed
a
level
that
was
authorized
by
this
tolerance
at
the
time
of
that
application.
EPA
will
take
action
to
revoke
this
tolerance
earlier
if
any
experience
with,
scientific
data
on,
or
other
relevant
information
on
this
pesticide
indicate
that
the
residues
are
not
safe.
Because
this
tolerance
is
being
approved
under
emergency
conditions,
EPA
has
not
made
any
decisions
about
whether
s­
metolachlor
meets
EPA's
registration
requirements
for
use
on
sweet
potatoes
or
whether
a
permanent
tolerance
for
this
use
would
be
appropriate.
Under
these
circumstances,
EPA
does
not
believe
that
this
tolerance
serves
as
a
basis
for
registration
of
smetolachlor
by
a
State
for
special
local
needs
under
FIFRA
section
24(
c).
Nor
does
this
tolerance
serve
as
the
basis
for
any
State
other
than
Louisiana
and
Mississippi
to
use
this
pesticide
on
this
crop
under
section
18
of
FIFRA
without
following
all
provisions
of
EPA's
regulations
implementing
FIFRA
section
18
as
identified
in
40
CFR
part
166.
For
additional
information
regarding
the
emergency
exemption
for
s­
metolachlor,
contact
the
Agency's
Registration
Division
at
the
address
provided
under
FOR
FURTHER
INFORMATION
CONTACT.

IV.
Aggregate
Risk
Assessment
and
Determination
of
Safety
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)
.
The
Agency
has
determined
that
the
residues
of
concern
for
plant
and
animal
commodities
are
metolachlor
and
its
metabolites,
determined
as
the
derivatives
CGA­
37913
and
CGA­
49751.
Metabolites
of
metolachlor
are
assumed
to
be
toxicologically
equivalent
to
parent
metolachlor.
The
residues
of
concern
for
s­
metolachlor
are
the
same
as
those
for
metolachlor.
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
s­
metolachlor
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
timelimited
tolerance
for
the
combined
residues
(
free
and
bound)
of
the
herbicide
s­
metolachlor
[(
S)­
2­
chloro­
N­
(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)
acetamide],
its
Renantiomer
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
sweet
potatoes
at
0.2
ppm.
EPA's
assessment
of
the
dietary
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
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
endpoint.
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
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
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
level
of
concern
(
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
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3,
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/
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and
Regulations
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*
approach
assumes
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
x10­
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
(
MOE
cancer
=
point
of
departure/
exposures)
is
calculated.
S­
metolachlor,
[
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)
acetamide],
is
a
member
of
the
chloroacetanilide
class
of
herbicides.
In
this
risk
assessment
the
term
s­
metolachlor
will
refer
to
a
metolachlor
product
which
is
enriched
in
the
S­
isomer.
The
term
metolachlor
will
refer
to
a
racemic
mixture
of
the
R
and
S
isomers.
Toxicological
endpoints
have
been
selected
for
metolachlor
and
smetolachlor
for
use
in
human
health
risk
assessments.
The
Agency
has
determined
that
metolachlor
and
smetolachlor
are
of
comparable
toxicity,
and
therefore,
studies
with
both
chemicals
were
used
interchangeably
for
toxicology
endpoint
selection.
A
summary
of
the
toxicological
endpoints
for
s­
metolachlor
used
for
human
risk
assessment
is
shown
in
the
following
Table
1:

TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
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
(
Females
13­
50
years
of
age)
NOAEL
=
300
mg/
kg/
day
UF
=
100
Acute
RfD
=
3.0
mg/
kg/
day
FQPA
SF
=
1x
aPAD
=
acute
RfD/
FQPA
SF
=
3.0
mg/
kg/
day
Prenatal
developmental
toxicity
study
in
rats
LOAEL
=
1,000
mg/
kg/
day
based
on
death,
clinical
signs
of
toxicity
(
clonic
and/
or
tonic
convulsions,
excessive
salivation,
urinestained
abdominal
fur
and/
or
excessive
salivation
and
decreased
body
weight
gain
Acute
Dietary
(
General
population
including
infants
and
children)
NOAEL
=
300
mg/
kg/
day
UF
=
100
Acute
RfD
=
3.0
mg/
kg/
day
FQPA
SF
=
1x
aPAD
=
acute
RfD/
FQPA
SF
=
3.0
mg/
kg/
day
Prenatal
developmental
toxicity
study
in
rats
LOAEL
=
1,000
mg/
kg/
day
based
on
death,
clinical
signs
of
toxicity
(
clonic
and/
or
tonic
convulsions,
excessive
salivation,
urinestained
abdominal
fur
and/
or
excessive
salivation
and
decreased
body
weight
gain
Chronic
Dietary
(
All
populations)
NOAEL
=
9.7
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.1
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
chronic
RfD/
FQPA
SF
=
0.1
mg/
kg/
day
Chronic
study
in
dogs
LOAEL
=
33.0
mg/
kg/
day
based
on
decreased
body
weight
gain
in
females
Short­
Term
Dermal
(
1
to
7
days)
(
Residential)
Hazard
was
not
identified
for
quantification
of
risk.
No
systemic
toxicity
was
seen
at
the
limit
dose
(
1,000
mg/
kg/
day)
following
dermal
applications
and
there
is
no
concern
for
developmental
toxicity
in
rats
or
rabbits.

Intermediate­
Term
Dermal
(
1
week
to
several
months)
(
Residential)
Hazard
was
not
identified
for
quantification
of
risk.
No
systemic
toxicity
was
seen
at
the
limit
dose
(
1000
mg/
kg/
day)
following
dermal
applications
and
there
is
no
concern
for
developmental
toxicity
in
rats
or
rabbits.

Long­
Term
Dermal
(
several
months
to
lifetime)
(
Residential
dermal
(
or
oral)
study
NOAEL=
9.7
mg/
kg/
day
(
dermal
absorption
rate
=
58%
when
appropriate)
LOC
for
MOE
=
100
(
Residential
Chronic
toxicity
study
in
dogs
LOAEL
=
33.0
mg/
kg/
day
based
on
decreased
body
weight
gain
in
females
Short­
Term
Inhalation
(
1
to
7
days)
(
Residential)
Inhalation
(
or
oral)
study
NOAEL=
50
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Prenatal
developmental
toxicity
study
in
rats
LOAEL
=
500
mg/
kg/
day
based
on
increased
incidence
of
clinical
signs,
decreased
body
weight/
body
weight
gain,
food
consumption,
and
food
efficiency
Intermediate­
Term
Inhalation
(
1
week
to
several
months)
(
Residential)
Inhalation
(
or
oral)
study
NOAEL
=
8.8
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Subchronic
(
6
month)
toxicity
study
in
dogs
LOAEL
based
on
decreased
body
weight
gain
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/
Friday,
January
3,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
S­
METOLACHLOR
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Long­
Term
Inhalation
(
several
months
to
lifetime)
(
Residential
Inhalation
(
or
oral)
study
NOAEL=
9.7
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Chronic
toxicity
study
in
dogs
LOAEL
=
33.0
mg/
kg/
day
based
on
decreased
body
weight
gain
in
females
Cancer
(
oral,
dermal,
inhalation)
Metolachlor
has
been
classified
as
a
Group
C,
possible
human
carcinogen.
This
classification
was
based
on
the
occurrence
of
liver
tumors
in
rats
at
the
highest
dose
level
tested
(
150
mg/
kg/
day).
The
carcinogenic
risks
for
metolachlor
have
been
quantitated
using
a
non­
linear
approach,
with
a
NOAEL
of
15
mg/
kg/
day.
However,
the
NOAEL
of
15
mg/
kg/
day
that
was
established
based
on
liver
tumors
in
rats
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.

*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

B.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
S­
metolachlor,
[
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)
acetamide],
is
a
member
of
the
chloroacetanilide
class
of
herbicides.
In
this
risk
assessment
the
term
s­
metolachlor
will
refer
to
a
metolachlor
product
which
is
enriched
in
the
S­
isomer.
The
term
metolachlor
will
refer
to
a
racemic
mixture
of
the
R
and
S
isomers.
Currently,
there
are
permanent
tolerances
for
metolachlor
(
40
CFR
180.368)
on
a
variety
of
crops
and
animal
commodities.
These
tolerances
range
from
0.02
ppm
to
30
ppm.
There
are
also
time­
limited
tolerances
(
in
conjunction
with
section
18
uses)
on
grass,
spinach,
and
tomatoes.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
metolachlor
and
smetolachlor
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
(
DEEMTM)
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:
The
analyses
assumed
tolerance­
level
residues
(
with
the
exception
of
those
with
DEEM
default
processing
factors)
and
100%
crop
treated
for
all
commodities.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
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
chronic
exposure
assessments:
The
analyses
assumed
tolerance­
level
residues
(
with
the
exception
of
those
with
DEEM
default
processing
factors)
and
100%
crop
treated
for
all
commodities.
iii.
Cancer.
Metolachlor
has
been
classified
as
a
Group
C,
possible
human
carcinogen.
This
classification
was
based
on
the
occurrence
of
liver
tumors
in
rats
at
the
highest
dose
level
tested
(
150
mg/
kg/
day).
The
carcinogenic
risks
for
metolachlor
have
been
quantitated
using
a
non­
linear
approach,
with
a
NOAEL
of
15
mg/
kg/
day.
However,
the
NOAEL
of
15
mg/
kg/
day
that
was
established
based
on
liver
tumors
in
rats
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.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
smetolachlor
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data
for
both
parent
and
the
degradates
of
concern
in
drinking
water,
exposure
from
drinking
water
is
being
addressed
through
modeled
estimated
environmental
concentrations
(
EECs)
and
the
use
of
drinking
water
levels
of
comparison
(
DWLOCs).
This
assessment
includes
concentrations
of
parent
metolachlor
and
the
degradates
metolachlor
ethanesulfonic
acid
(
ESA)
and
metolachlor
oxanilic
acid
(
OA).
Although
it
was
determined
by
the
Agency
that
the
ESA
and
OA
metabolites
appear
to
be
less
toxic
than
parent
metolachlor,
they
are
included
in
this
risk
assessment
because
they
were
found
in
greater
abundance
than
the
parent
in
water
monitoring
studies.
The
surface
water
EECs
were
derived
from
the
National
Water
Quality
Assessment
Database
(
parent)
and
the
FIRST
Model
(
ESA
and
OA
metabolites).
The
SCI­
GROW
Model
was
used
to
generate
all
ground­
water
EECs
For
a
screening­
level
assessment
for
surface
water
EPA
will
generally
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
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/
Rules
and
Regulations
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
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
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
metolachlor
and
s­
metolachlor
they
are
further
discussed
in
the
aggregate
risk
sections
below.
Based
on
the
National
Water
Quality
Assessment
Database
(
parent)
and
the
FIRST
Model
(
ESA
and
OA
metabolites)
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(
EECs)
of
parent
metolachlor
and
its
degradates
for
acute
exposures
are
estimated
to
be
201
parts
per
billion
(
ppb)
(
parent:
77.6
ppb,
ESA:
31.9
ppb,
and
OA:
91.4
ppb)
for
surface
water
and
103
ppb
(
parent:
5.5
ppb,
ESA:
65.8
ppb,
and
OA:
31.7
ppb)
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
92
ppb
(
parent:
4.3
ppb,
ESA:
22.8
ppb,
and
OA:
65.1
ppb)
for
surface
water
and
103
ppb
(
parent:
5.5
ppb,
ESA:
65.8
ppb,
and
OA:
31.7
ppb)
for
ground
water.
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).
i.
Handlers.
Metolachlor
and
smetolachlor
are
registered
(
as
an
emulsifiable
concentrate
formulation)
for
use
on
lawn,
turf
(
including
sod
farms),
golf
courses,
sports
fields,
and
ornamental
gardens.
Although
metolachlor
is
not
labeled
as
a
restricted­
use
pesticide,
it
is
not
intended
for
homeowner
purchase
or
use.
On
this
basis,
a
residential
handler
is
not
expected
to
be
exposed
to
residues
of
metolachlor
and
smetolachlor
Therefore,
a
residential
handler
assessment
was
not
conducted.
ii.
Postapplication.
There
is
potential
for
postapplication
exposure
to
adults
and
children
resulting
from
the
use
of
metolachlor/
s­
metolachlor
on
residential
lawns.
Although
the
use
sites
for
metolachlor
and
s­
metolachlor
vary
from
golf
courses
to
ornamental
gardens,
the
residential
lawn
scenario
represents
what
the
Agency
considers
to
be
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
(
one
to
30
days
of
exposure)
only,
based
on
a
label
specification
of
a
six
week
interval
before
the
re­
application
of
metolachlor/
s­
metolachlor.
The
registrant
has
also
indicated
a
label
revision
to
limit
application
to
one
time
per
season.
A
short­
term
dermal
endpoint
was
not
selected
because
no
systemic
toxicity
was
seen
at
the
limit
dose
of
1,000
mg/
kg/
day.
As
a
result,
a
dermal
risk
assessment
was
not
conducted
and
dermal
risks
are
assumed
to
be
minimal.
Postapplication
inhalation
exposure
is
expected
to
be
minimal
since
metolachlor
and
s­
metolachlor
are
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
which
result
from
application
to
lawns
and
turf
have
been
identified:
a.
Short­
term
oral
exposure
to
toddlers
and
children
following
handto
mouth
exposure;
b.
Short­
term
oral
exposure
to
toddlers
and
children
following
objectto
mouth
exposure;
and
c.
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.
As
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.
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
smetolachlor
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,
smetolachlor
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
s­
metolachlor
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).

C.
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.
Developmental
toxicity
studies
 
i.
Prenatal
developmental
toxicity
study
 
Metolachlor
 
Rat.
The
maternal
toxicity
LOAEL
was
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.
The
NOAEL
was
300
mg/
kg/
day.
The
developmental
toxicity
LOAEL
was
conservatively
established
at
1,000
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.
The
NOAEL
was
300
mg/
kg/
day.
ii.
Prenatal
developmental
toxicity
study
 
S­
metolachlor
 
Rat.
The
maternal
toxicity
NOAEL
was
50
mg/
kg/
day
with
a
LOAEL
of
500
mg/
kg/
day
based
on
increased
clinical
signs
of
toxicity,
decreased
body
weights
and
body
weight
gains
and
reduced
food
consumption
and
reduced
food
efficiency.
No
significant
treatment
related
developmental
toxicity
was
noted
at
the
dose
levels
tested.
The
developmental
toxicity
NOAEL
was
equal
to
or
greater
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than
1,000
mg/
kg/
day,
the
highest
dose
tested
(
HDT);
a
LOAEL
was
not
reached.
iii.
Prenatal
developmental
toxicity
study
 
Metolachlor
 
Rabbit.
The
maternal
toxicity
LOAEL
was
360
mg/
kg/
day
based
on
an
increased
incidence
of
clinical
observations
(
persistent
anorexia)
and
decreased
body
weight
gain.
The
NOAEL
was
120
mg/
kg/
day.
The
developmental
toxicity
LOAEL
was
not
established.
The
NOAEL
was
360
mg/
kg/
day.
iv.
Prenatal
developmental
toxicity
study
 
S­
metolachlor
 
Rabbit.
The
maternal
toxicity
NOAEL
was
20
mg/
kg/
day
with
a
LOAEL
of
100
mg/
kg/
day
based
on
clinical
signs
of
toxicity.
No
significant
treatment
related
developmental
toxicity
was
noted
at
the
dose
levels
tested.
The
developmental
toxicity
NOAEL
was
equal
to
or
greater
than
500
mg/
kg/
day,
HDT;
a
LOAEL
was
not
reached.
3.
Reproductive
toxicity
study.
No
reproduction
studies
with
s­
metolachlor
are
available,
however,
in
the
twogeneration
reproduction
study
with
metolachlor
in
rats,
there
was
no
evidence
of
parental
or
reproductive
toxicity
at
approximately
80
mg/
kg/
day,
HDT.
At
this
dose,
there
was
a
minor
decrease
in
fetal
body
weight
beginning
at
lactation
day
4;
the
NOAEL
was
approximately
25
mg/
kg/
day.
Since
a
similar
body
weight
decrease
was
not
seen
on
lactation
day
0,
the
cause
of
the
effect
on
later
lactation
days
was
most
likely
due
to
exposure
of
the
pups
to
metolachlor
in
the
diet
and/
or
milk
and
therefore
is
not
evidence
of
an
increased
quantitative
susceptibility
in
post­
natal
animals.
The
parental
toxicity
LOAEL
was
not
established.
The
NOAEL
was
1000
ppm
(
F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1males/
females:
76.6/
84.5
mg/
kg/
day).
The
reproductive
toxicity
LOAEL
was
not
established.
The
NOAEL
was
1000
ppm
(
F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1males/
females:
76.6/
84.5
mg/
kg/
day).
The
offspring
LOAEL
was
conservatively
established
at
1000
ppm
(
F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1males/
females:
76.6/
84.5
mg/
kg/
day)
based
on
decreased
body
weight
in
F1
and
F2
litters.
The
NOAEL
is
300
ppm
(
F0
males/
females:
23.5/
26.0
mg/
kg/
day;
F1males/
females:
23.7/
25.7
mg/
kg/
day).
4.
Prenatal
and
postnatal
sensitivity.
The
data
bases
for
prenatal
developmental
toxicity
for
metolachlor
and
s­
metolachlor
are
considered
complete.
The
prenatal
developmental
studies
in
the
rat
and
rabbit
with
both
metolachlor
and
s­
metolachlor
revealed
no
evidence
of
a
qualitative
or
quantitative
susceptibility
in
fetal
animals.
No
significant
developmental
toxicity
was
observed
in
most
studies
even
at
the
HDT.
The
data
base
for
reproductive
toxicity
of
metolachlor
is
considered
complete.
No
reproduction
studies
with
s­
metolachlor
are
available.
In
the
twogeneration
reproduction
study
with
metolachlor
in
rats,
there
was
no
evidence
of
parental
or
reproductive
toxicity
at
approximately
80
mg/
kg/
day,
HDT.
At
this
dose,
there
was
a
minor
decrease
in
fetal
body
weight
beginning
at
lactation
day
4;
the
NOAEL
was
approximately
25
mg/
kg/
day.
Since
a
similar
body
weight
decrease
was
not
seen
on
lactation
day
0,
the
cause
of
the
effect
on
later
lactation
days
was
most
likely
due
to
exposure
of
the
pups
to
metolachlor
in
the
diet
and/
or
milk
and
therefore
is
not
evidence
of
an
increased
quantitative
susceptibility
in
post­
natal
animals.
5.
Conclusion.
There
is
a
complete
toxicity
data
base
for
s­
metolachlor
when
bridged
with
the
database
for
metolachlor
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
safety
factor
to
protect
infants
and
children
should
be
removed.
The
FQPA
factor
is
removed
because:
i.
The
toxicological
database
is
complete
for
FQPA
assessment;
ii.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure;
iii.
A
developmental
neurotoxicity
study
is
not
required;
and
iv.
The
dietary
(
food
and
drinking
water)
and
residential
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.

D.
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
+
chronic
non­
dietary,
nonoccupational
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
the
Office
of
Water
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
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
smetolachlor
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
s­
metolachlor
on
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.

1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
s­
metolachlor
will
occupy
<
1
%
of
the
aPAD
for
the
U.
S.
population,
<
1
%
of
the
aPAD
for
females
13
years
and
older,
<
1
%
of
the
aPAD
for
all
infant
and
children
subpopulations.
In
addition,
despite
the
potential
for
acute
dietary
exposure
to
smetolachlor
in
drinking
water,
after
calculating
DWLOCs
and
comparing
them
to
conservative
model
estimated
environmental
concentrations
of
smetolachlor
in
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
Table
2
of
this
unit:

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Regulations
TABLE
2.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
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
201
103
1.0
x
105
All
Infants
(<
1
year
old)
3.0
<
1
201
103
3.0
x
104
Children
(
1­
6
years
old)
3.0
<
1
201
103
3.0
x
104
Children
(
7­
12
years
old)
3.0
<
1
201
103
3.0
x
104
Females
(
13­
50
years
old)
3.0
<
1
201
103
9.0
x
104
Males
(
13­
19
years
old)
3.0
<
1
201
103
1.0
x
105
Males
(
20+
years
old)
3.0
<
1
201
103
1.0
x
105
Seniors
(
55+
years
old)
3.0
<
1
201
103
1.0
x
105
*
Represents
the
combined
value
of
parent
plus
the
ESA
and
OA
degradates.

2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
s­
metolachlor
from
food
will
utilize
2
%
of
the
cPAD
for
the
U.
S.
population,
2
%
of
the
cPAD
for
all
infants
<
1
year
old
and
3
%
of
the
cPAD
for
children
1­
6
years
old.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
s­
metolachlor
is
not
expected.
In
addition,
despite
the
potential
for
chronic
dietary
exposure
to
s­
metolachlor
in
drinking
water,
after
calculating
DWLOCs
and
comparing
them
to
conservative
model
estimated
environmental
concentrations
of
smetolachlor
in
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
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
103
3400
All
Infants
(<
1
year
old)
0.1
2
92
103
980
Children
(
1­
6
years
old)
0.1
3
92
103
970
Children
(
7­
12
years
old)
0.1
2
92
103
980
Females
(
13­
50
years
old)
0.1
1
92
103
3000
Males
(
13­
19
years
old)
0.1
2
92
103
3400
Males
(
20+
years
old)
0.1
1
92
103
3500
Seniors
(
55+
years
old)
0.1
1
92
103
3500
3.
Short­
term
risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
For
metolachlor
and
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
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
both
metolachlor
and
s­
metolachlor,
with
the
only
difference
in
the
calculations
being
different
oral
exposure
values
for
metolachlor
vs.
s­
metolachlor
(
based
on
different
application
rates).
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
640
for
metolachlor
and
1000
for
s­
metolachlor
for
children
1­
6
years
old
(
the
only
population
sub­
group
of
concern.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
s­
metolachlor
in
ground
water
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
4
of
this
unit:

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TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
METOLACHLOR
AND
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
6);
Metolachlor
640
100
92
103
4,200
Children
(
1­
6);
S­
Metolachlor
1,100
100
92
103
4,500
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,
no
intermediate­
term
non­
occupational
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.
Metolachlor
has
been
classified
as
a
Group
C,
possible
human
carcinogen.
This
classification
was
based
on
the
occurrence
of
liver
tumors
in
rats
at
the
highest
dose
level
tested
(
150
mg/
kg/
day).
The
HED
Cancer
Assessment
Review
Committee
has
recommended
that
carcinogenic
risks
for
metolachlor
be
quantitated
using
a
non­
linear
approach,
with
a
NOAEL
of
15
mg/
kg/
day.
However,
the
NOAEL
of
15
mg/
kg/
day
that
was
established
based
on
liver
tumors
in
rats
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
from
aggregate
exposure
to
smetolachlor
residues.

V.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
Pesticide
Analytical
Manual
(
PAM)
Vol.
II,
lists
a
GC/
NPD
method
(
Method
I)
for
determining
residues
in/
on
plants
and
a
GC/
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.

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.

VI.
Conclusion
Therefore,
the
tolerance
is
established
for
the
combined
residues
(
free
and
bound)
of
the
herbicide
s­
metolachlor
[(
S)­
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)
acetamide,
its
Renantiomer
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
sweet
potatoes
at
0.2
ppm.

VII.
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
the
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
 
0331
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
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/
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January
3,
2003
/
Rules
and
Regulations
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
VII.
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
the
docket
ID
number
OPP
 
2002
 
0331,
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:
opp­
docket@
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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

VIII.
Regulatory
Assessment
Requirements
This
final
rule
establishes
a
timelimited
tolerance
under
section
408
of
the
FFDCA.
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
FIFRA
section
18
exemption
under
section
408
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.

IX.
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
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Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Rules
and
Regulations
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
180.368
is
amended
by
designating
the
existing
paragraph
(
b)
as
paragraph
(
b)(
1)
and
adding
a
new
paragraph
(
b)(
2)
to
read
as
follows:

§
180.368
Metolachlor;
tolerances
for
residues.

*
*
*
*
*
(
b)
Section
18
emergency
exemptions.
(
1)
*
*
*
(
2)
Time­
limited
tolerances
are
established
for
the
combined
residues
(
free
and
bound)
of
the
herbicide
smetolachlor
[(
S)­
2­
chloro­
N­(
2­
ethyl­
6­
methylphenyl)­
N­(
2­
methoxy­
1­
methylethyl)
acetamide],
its
Renantiomer
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
connection
with
the
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
EPA.
The
tolerance
is
specified
in
the
following
table.
The
tolerances
will
expire
and
are
revoked
on
the
dates
specified
in
the
following
table.

Commodity
Parts
per
million
Expiration/
Revocation
Date
Sweet
potato
0.2
12/
31/
04
*
*
*
*
*

[
FR
Doc.
03
 
5
Filed
1
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0335;
FRL
 
7285
 
2]

Lambda­
cyhalothrin;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
time­
limited
tolerances
for
combined
residues
of
the
pyrethroid
lambdacyhalothrin
1:
1
mixture
of
(
S)­
a­
cyano­
3­
phenoxybenzyl­(
Z)­(
1R,
3R)­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,2­
dimethylcyclopropanecarboxylate
and
(
R)­
a­
cyano­
3­
phenoxybenzyl­(
Z)­
(
1S,
3S)­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,2­
dimethylcyclopropanecarboxylate
and
its
epimer
expressed
as
epimer
of
lambda­
cyhalothrin,
a
1:
1
mixture
of
(
S)­
a­
cyano­
3­
phenoxybenzyl­(
Z)­
(
1S,
3S)
­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,2­
dimethylcyclopropanecarboxylate
and
(
R)­
a­
cyano­
3­
phenoxybenzyl­(
Z)­
(
1R,
3R)­
3­(
2­
chloro­
3,3,3­
trifluoroprop­
1­
enyl)­
2,2­
dimethylcyclopropanecarboxylate
in
or
on
wild
rice,
grass
forage,
and
grass
hay.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
the
pesticide
on
wild
rice
and
pasture
grass.
This
regulation
establishes
maximum
permissible
levels
for
residues
of
lambda­
cyhalothrin
and
its
epimer
in
these
food
commodities.
The
tolerances
will
expire
and
are
revoked
on
December
31,
2005.
DATES:
This
regulation
is
effective
January
3,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0335,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Andrew
Ertman,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9367;
e­
mail
address:
sec­
18­
mailbox@
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
a
Federal
or
State
government
agency
involved
in
administration
of
environmental
quality
programs
(
i.
e.,
Departments
of
Agriculture,
Environment,
etc).
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Federal
or
State
Government
Entity,
(
NAICS
9241),
i.
e.,
Departments
of
Agriculture,
Environment,
etc.
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
 
0335.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml__
00/
Title__
40/
40cfr180_(_
00.
html,
a
beta
site
currently
under
development.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
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