40791
Federal
Register
/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Rules
and
Regulations
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
the
rule
in
the
Federal
Register.
A
major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
Under
section
307(
b)(
1)
of
the
Clean
Air
Act,
petitions
for
judicial
review
of
this
action
must
be
filed
in
the
United
States
Court
of
Appeals
for
the
appropriate
circuit
by
September
8,
2003.
Filing
a
petition
for
reconsideration
by
the
Administrator
of
this
final
rule
does
not
affect
the
finality
of
this
rule
for
the
purposes
of
judicial
review
nor
does
it
extend
the
time
within
which
a
petition
for
judicial
review
may
be
filed,
and
shall
not
postpone
the
effectiveness
of
such
rule
or
action.
This
action
may
not
be
challenged
later
in
proceedings
to
enforce
its
requirements.
(
See
section
307(
b)(
2).)
List
of
Subjects
40
CFR
Part
52
Environmental
protection,
Air
pollution
control,
Hydrocarbons,
Incorporation
by
reference,
Intergovernmental
relations,
Nitrogen
dioxide,
Ozone,
Reporting
and
recordkeeping
requirements,
Volatile
organic
compounds.

40
CFR
Part
81
Environmental
protection,
Air
pollution
control,
National
parks,
Wilderness
areas.

Dated:
June
6,
2003.
Alexis
Strauss,
Acting
Regional
Administrator,
Region
IX.


Chapter
I,
title
40
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
52
 
[
AMENDED]


1.
The
authority
citation
for
Part
52
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401
et
seq.

Subpart
F
 
California

2.
Section
52.220
is
amended
by
adding
paragraph
(
c)(
314)
to
read
as
follows:
§
52.220
Identification
of
plan.

*
*
*
*
*
(
c)
*
*
*
(
314)
New
and
amended
plan
for
the
following
agency
was
submitted
on
February
21,
2003,
by
the
Governor's
designee.
(
i)
Incorporation
by
reference.
(
A)
Santa
Barbara
County
Air
Pollution
Control
District.
(
1)
Emission
Inventories,
1­
hour
ozone
maintenance
demonstration,
commitments
to
continue
ambient
monitoring
and
to
track
progress,
and
contingency
measures,
as
contained
in
the
Final
2001
Clean
Air
Plan
adopted
on
December
19,
2002.
*
*
*
*
*

PART
81
 
[
AMENDED]


1.
The
authority
citation
for
Part
81
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401
et
seq.


2.
In
§
81.305,
the
California
Ozone
(
1
 
Hour
Standard)
table
is
amended
by
revising
the
entry
for
the
Santa
Barbara­
Santa
Maria­
Lompoc
Area:
to
read
as
follows:

§
81.305
California.

*
*
*
*
*

CALIFORNIA
 
OZONE
(
1
 
HOUR
STANDARD)

Designated
area
Designation
Classification
Date
1
Type
Date
1
Type
*
*
*
*
*
*
*
Santa
Barbara­
Santa
Maria­
Lompoc
Area:
..............................
..............................................
Attainment.
Santa
Barbara
County
.......................................................
August
8,
2003.

*
*
*
*
*
*
*

1
This
date
is
November
15,
1990,
unless
otherwise
noted.

*
*
*
*
*
[
FR
Doc.
03
 
17210
Filed
7
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0220;
FRL
 
7316
 
6]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
emamectin
and
its
metabolites
in
or
on
Brassica
leafy
vegetables
(
crop
group
5);
turnip
greens;
cotton,
undelinted
seed;
cotton
gin
byproduct;
leafy
vegetables
(
except
Brassica)
(
crop
group
4);
fruiting
vegetables
(
crop
group
8);
and
tomato
paste.
In
addition,
tolerances
are
established
for
indirect
or
inadvertent
combined
residues
of
emamectin
and
the
associated
8,9­
Z
isomers
in
or
on
milk
and
fat
of
cattle,
goats,
hogs,
horses,
and
sheep;
meat
byproducts,
except
liver,
of
cattle,
goats,
hogs,
horses
,
and
sheep;
liver
of
cattle,
goats,
hogs,
horses,
and
sheep;
and
meat
of
cattle,
goat,
hogs,
horses,
and
sheep.
Syngenta
Crop
Protection,
Inc.
requested
this
tolerance
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
July
9,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0220,
must
be
received
on
or
before
September
8,
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:
Thomas
C.
Harris,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,

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Federal
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/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Rules
and
Regulations
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9423;
e­
mail
address:
harris.
thomas@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
Production
(
NAICS
111,
e.
g.)
 
Animal
Production
(
NAICS
112,
e.
g.)
 
Food
Manufacturing
(
NAICS
311,
e.
g.)
 
Pesticide
Manufacturing
(
NAICS
32532,
e.
g.)
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
 
0220.
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
March
20,
2002
(
67
FR
12990)
(
FRL
 
6824
 
4),
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
a
pesticide
petition
(
PP
7F4845)
by
Syngenta
Crop
Protection,
Inc.,
P.
O.
Box
18300,
Greensboro,
NC
27419.
That
notice
included
a
summary
of
the
petition
prepared
by
Syngenta
Crop
Protection,
Inc.,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
original
petition
requested
that
40
CFR
180.505
be
amended
by
establishing
a
tolerance
for
combined
residues
of
the
insecticide
emamectin
benzoate,
4 ­
epi­
methylamino­
4 ­
deoxyavermectin
B1
benzoate
(
a
mixture
of
a
minimum
of
90%
4 ­
epimethylamino
4 ­
deoxyavermectin
B1a
and
a
maximum
of
10%
4 ­
epimethlyamino
4 
deoxyavermectin
B1b
benzoate),
and
its
metabolites
8,9
isomer
of
the
B1a
and
B1b
component
of
the
parent
insecticide
in
or
on
the
raw
agricultural
commodities
fruiting
vegetables
(
except
Cucurbits)
group
at
0.02
parts
per
million
(
ppm),
Brassica
leafy
vegetables
group
at
0.025
ppm,
leafy
vegetables
(
except
Brassica)
group
at
0.1
ppm,
cottonseed
at
0.025
ppm,
cotton
gin
byproducts
at
0.5
ppm.
Based
on
the
EPA
analysis
of
the
residue
chemistry
and
toxicological
databases,
the
petition
was
subsequently
revised
to
express
the
tolerance
as
the
combined
residues
of
emamectin,
(
a
mixture
of
a
minimum
of
90%
4 ­
epimethylamino
4 ­
deoxyavermectin
B1a
and
maximum
of
10%
4 ­
epimethylamino
4 ­
deoxyavermectin
B1b)
and
its
metabolites
8,9­
isomer
of
the
B1a
and
B1b
component
of
the
parent
(
8,9­
ZMA),
or
4 ­
deoxy­
4 ­
epi­
aminoavermectin
B1a
and
4 ­
deoxy­
4 ­
epiamino
avermectin
B1b;
4 ­
deoxy­
4 ­
epiamino
avermectin
B1a
(
AB1a);
4 ­
deoxy­
4 ­
epi­(
N­
formyl­
N­
methyl)
aminoavermectin
(
MFB1a);
and
4 ­
deoxy­
4 ­
epi­(
N­
formyl)
amino­
avermectin
B1a
(
FAB1a),
in
or
on
Brassica
leafy
vegetables
(
crop
group
5)
at
0.05
ppm;
turnip
greens
at
0.05
ppm;
cotton,
undelinted
seed
at
0.025
ppm;
cotton
gin
byproduct
at
0.05
ppm;
leafy
vegetables
(
except
Brassica)
(
crop
group
4)
at
0.10
ppm;
fruiting
vegetables
(
crop
group
8)
at
0.02
ppm;
and
tomato
paste
at
0.15
ppm.
In
addition,
tolerances
are
established
for
indirect
or
inadvertent
combined
residues
of
emamectin
(
MAB1a
+
MAB1b
isomers)
and
the
associated
8,9­
Z
isomers
(
8,9­
ZB1a
+
8,9­
ZB1b)
in
or
on
milk
and
fat
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.003
ppm;
meat
byproducts,
except
liver,
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.005
ppm;
liver
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.020
ppm;
and
meat
of
cattle,
goat,
hogs,
horses,
and
sheep
at
0.002
ppm.
Note
that
the
tolerance
expression
in
40
CFR
180.505
is
being
changed
from
emamectin
benzoate
to
emamectin
since
the
enforcement
method,
Method
244
 
92
 
3,
Revision
1,
analyzes
residues
of
emamectin
MAB1
isomers
(
not
emamectin
benzoate),
8,9­
ZMA,
AB1a,
MFB1a,
and
FAB1a
in/
on
crops.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue....''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
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/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Rules
and
Regulations
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
emamectin,
(
a
mixture
of
a
minimum
of
90%
4 ­
epi­
methylamino­
4 ­
deoxyavermectin
B1a
and
maximum
of
10%
4 ­
epi­
methylamino­
4 ­
deoxyavermectin
B1b)
and
its
metabolites
8,9­
isomer
of
the
B1a
and
B1b
component
of
the
parent
(
8,9­
ZMA),
or
4 ­
deoxy­
4 ­
epi­
amino­
avermectin
B1a
and
4 ­
deoxy­
4 ­
epi­
amino­
avermectin
B1b;
4 ­
deoxy­
4 ­
epi­
amino
avermectin
B1a
(
AB1a);
4 ­
deoxy­
4 ­
epi­(
N­
formyl­
Nmethyl
amino­
avermectin
(
MFB1a);
and
4 ­
deoxy­
4 ­
epi­(
N­
formyl)
aminoavermectin
B1a
(
FAB1a),
in
or
on
Brassica
leafy
vegetables
(
crop
group
5)
at
0.05
ppm;
turnip
greens
at
0.05
ppm;
cotton,
undelinted
seed
at
0.025
ppm;
cotton
gin
byproduct
at
0.05
ppm;
leafy
vegetables
(
except
Brassica)
(
crop
group
4)
at
0.10
ppm;
fruiting
vegetables
(
crop
group
8)
at
0.02
ppm;
and
tomato
paste
at
0.15
ppm.
In
addition,
tolerances
are
established
for
indirect
or
inadvertent
combined
residues
of
emamectin
(
MAB1a
+
MAB1b
isomers)
and
the
associated
8,9­
Z
isomers
(
8,9­
ZB1a
+
8,9­
ZB1b)
in
or
on
milk
and
fat
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.003
ppm;
meat
byproducts,
except
liver,
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.005
ppm;
liver
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.020
ppm;
and
meat
of
cattle,
goat,
hogs,
horses,
and
sheep
at
0.002
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
emamectin
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
Subchronic­
Feeding­
Rat
MK
 
0243
Systemic
Toxicity
NOAEL=
2.5
mg/
kg/
day.
Systemic
Toxicity
LOAEL=
5
mg/
kg/
day
based
on
tremors,
hindlimb
splaying,
urogenital
staining,
histological
changes
in
brain
and
spinal
cord,
sciatic
and
optic
nerves
and
skeletal
muscles
in
males,
emaciation,
reduced
body
weight
and
reduced
food
consumption
in
both
sexes.

870.3150
Subchronic­
Feeding­
Dog
MK
 
0243
Systemic
Toxicity
NOAEL=
0.25
mg/
kg.
Systemic
Toxicity
LOAEL=
0.50
mg/
kg
based
on
microscopic
pathological
signs
of
neurotoxicity
consisting
of
skeletal
muscle
atrophy
and
white
matter
multifocal
degeneration
in
the
brains
of
both
sexes
and
white
matter
multifocal
degeneration
in
the
spinal
cords
of
males.

870.3200
21
 
Day
Dermal
Toxicity­
Rat
No
Study
Available.

870.3700
Developmental
Toxicity­
Rat
MK
 
0243
Maternal
Toxicity
NOAEL=
2
mg/
kg/
day.
Maternal
Toxicity
LOAEL=
4
mg/
kg/
day
based
on
a
significant
trend
towards
decreased
body
weight
gain
during
the
dosing
period.
Developmental
Toxicity
NOAEL=
4
mg/
kg/
day.
Developmental
Toxicity
LOAEL=
8
mg/
kg/
day
based
on
altered
growth
and
an
increased
incidence
of
supernumerary
rib.

870.3700
Developmental
Toxicity­
Rabbit
MK
 
0243
Maternal
Toxicity
NOAEL=
3
mg/
kg/
day.
Maternal
Toxicity
LOAEL=
6
mg/
kg/
day
based
on
a
significant
trend
towards
decreased
body
weight
gain
during
dosing
period
and
increased
clinical
signs
(
mydriasis
and
decreased
pupillary
reaction).
Developmental
Toxicity
NOAEL=
6
mg/
kg/
day.
Developmental
Toxicity
LOAEL=
Not
Determined.

870.3800
Reproductive
Toxicity­
Rat
MK
 
0244
Systemic
Toxicity
NOAEL=
0.6
mg/
kg/
day.
Systemic
Toxicity
LOAEL=
1.8
mg/
kg/
day
based
on
decreased
body
weight
gain
and
histopathological
changes
(
neuronal
degeneration
in
the
brain
and
spinal
cord)
in
both
sexes
and
generations.
Reproductive
Toxicity
NOAEL=
0.6
mg/
kg/
day.
Reproductive
Toxicity
LOAEL=
1.8
mg/
kg/
day
based
on
decreased
fecundity
and
fertility
indices
and
clinical
signs
(
tremors
and
hind
limb
extension)
in
offspring
of
both
generations

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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.4100
Chronic­
Feeding­
Dog
MK
 
0244
Systemic
Toxicity
NOAEL=
0.25
mg/
kg/
day.
Systemic
Toxicity
LOAEL=
0.5
mg/
kg/
day
based
on
axonal
degeneration
in
the
pons,
medulla
and
peripheral
nerves
(
sciatic,
sural,
and
tibial)
in
both
sexes,
clinical
signs
of
neurotoxicity
(
whole
body
tremors,
stiffness
of
the
hind
legs),
spinal
cord
axonal
degeneration,
and
muscle
fiber
degeneration
in
females.

870.4100
Chronic
Feeding­
Rat
MK
 
0244
Systemic
Toxicity
NOAEL=
1.0
mg/
kg/
day.
Systemic
Toxicity
LOAEL=
2.5
mg/
kg/
day,
based
on
increased
incidence
of
neuronal
degeneration
in
the
brain
and
spinal
cord,
decreased
rearing,
and
an
increased
incidence
of
animals
with
low
arousal.

870.4200
Carcinogenicity­
Mouse
(
78
 
week)
MK
 
0244
Systemic
Toxicity
NOAEL=
2.5
mg/
kg/
day.
Systemic
Toxicity
LOAEL=
5.0
mg/
kg/
day
for
males
and
7.5
mg/
kg/
day
for
females
based
on
increased
mortality,
decreased
weight
gain,
neurological
signs,
and
increased
incidence
of
severity
of
infections.
There
were
no
signs
of
carcinogenicity
in
this
study.

870.4300
Chronic
Toxicity/
Carcinogenicity­
Rat
Emamectin
Systemic
Toxicity
NOAEL=
1.0
mg/
kg/
day.
Systemic
Toxicity
LOAEL=
2.5/
5.0
mg/
kg/
day
based
on
marked
neural
degeneration
in
the
brain
and
spinal
cord
of
both
sexes,
brain
white
matter
degeneration
in
males,
and
on
decreased
body
weight,
body
weight
gain,
and
food
efficiency
in
males.
There
were
no
signs
of
carcinogenicity
in
this
study.
Note:
The
initial
dose
of
the
high
dose
group
was
5.0
mg/
kg/
day.
Due
to
unacceptable
weight
loss
and/
or
tremors
occurring
at
this
dose
in
another
concurrent
study
(
TT#
91
 
006
 
0)
during
week
9
in
males
and
week
11
in
females,
the
dose
was
lowered
to
2.5
mg/
kg/
day
starting
at
week
6
in
males
and
week
10
in
females.

870.5100
Gene
Mutation
­
Salmonella
MK
 
0243
and
L
 
660,599;
L
 
657,831;
L
 
695,638;
L
 
930,905
(
photometabolites
of
MK
 
0244)
Negative
for
the
induction
of
reverse
gene
mutation
870.5300
Gene
Mutation
in
Cultured
V
 
79
Chinese
Hamster
Lung
Cells
MK
 
0243
Negative
for
the
induction
of
forward
gene
mutations
in
Chinese
hamster
lung
fibroblast
cells
up
to
a
severely
cytotoxic
nonactivated
dose
of
0.01mM
or
a
severely
cytotoxic
S9­
activated
dose
of
0.04mM.

870.5385
Structural
Chromosome
Aberration­
in
vivo
mouse
bone
marrowMK
 
0244
Negative
for
the
induction
of
chromosome
aberrations
in
the
bone
marrow
cells
of
male
CD
 
1
mice.

870.5500
DNA
Damage­
Rat
hepatocytes
MK
 
0243
Negative
for
the
induction
of
single
strand
breaks
(
SBs)
in
DNA
of
rat
hepatocytes.

870.6200
Acute
Oral
Neurotoxicity
­
Rat
MK
 
0243
A
Neurotoxicity
NOAEL
was
not
established,
since
toxic
signs
of
neurotoxicity
as
well
as
histological
lesions
in
the
brain,
spinal
cord
and
sciatic
nerve
occurred
at
all
doses
tested
(
27.4,
54.8
or
82.2
mg/
kg)

870.6200
Subchronic
Neurotoxicity­
Rat
MK
 
0243
Neurotoxicity
NOAEL=
1.0
mg/
kg/
day.
LOAEL=
5.0
mg/
kg/
day
(
highest
dose
tested)
based
on
mild
tremors,
posture,
rearing,
excessive
salivation,
fur
appearance
gait,
strength,
mobility
and
righting
reflex.

870.6200
2
 
Week
Dietary
Neurotoxicity
 
CD
 
1
Mice
MK
 
0243
Neurotoxicity
NOAEL=
2.0
mg/
kg/
day
(
highest
dose
tested).
No
characteristic
neuronal
lesions
in
the
brain,
spinal
cord
or
sciatic
nerve
in
mice
of
high
dose
group
(
2.0
mg/
kg/
day).

870.6200
15
 
day
Dietary
Neurotoxicity­
CF
 
1
Mice
MK
 
244
Neurotoxicity
NOAEL=
0.075
mg/
kg/
day.
LOAEL=
0.10
mg/
kg/
day
based
on
tremors
observed
beginning
on
day
3,
decreases
in
body
weight
and
food
consumption
as
well
as
degeneration
of
the
sciatic
nerve.

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Vol.
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No.
131
/
Wednesday,
July
9,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.6200
Dietary
Neurotoxicity­
CF
 
1
Mice
L
 
660,599
Supplementary
Study
Neurotoxicity
NOAEL
<
0.1
mg/
kg/
day.
One
of
the
low­
dose
males
had
tremors,
hunched
posture
and
piloerection
on
day
14.

870.6300
Developmental
Neurotoxicity­
Rat
MK
 
0244
Maternal
Toxicity
NOAEL=
3.6/
2.5
mg/
kg/
day
(
highest
dose
tested).
Developmental
Neurotoxicity
NOAEL=
0.10
mg/
kg/
day
(
lowest
dose
tested).
The
LOAEL
is
0.60
mg/
kg/
day
based
on
the
dose­
related
decrease
in
open
field
motor
activity
in
females
at
postnatal
day
17.

870.7485
Metabolism­
Rat
MAB1a
Radiolabeled
MAB1a
benzoate
is
rapidly
absorbed,
distributed
and
excreted
following
oral
and
i.
v.
administration.
The
feces
was
the
major
route
of
excretion
in
oral
and
i.
v.
groups,
while
<
1%
of
the
administered
dose
was
recovered
in
the
urine
7
days
post
dosing.
Tissue
distribution
and
bioaccumulation
appeared
minimal.
The
metabolism
of
MAB1a
benzoate
appears
to
involve
primarily
Ndemethylation
to
AB1a.
AB1a
was
the
only
metabolite
detected
in
the
feces
while
unmetabolized
parent
compound
represented
a
large
amount
of
the
radioactivity.

870.7485
Bioequivalence­
Dog
MK
 
0243
solvate/
monohydrate
The
study
demonstrated
that
MK
 
0243
benzoate
MTBE
solvate
and
MK
 
0243
benzoate
monohydrate
were
bioequivalent
in
male
dogs
following
oral
administration
as
indicated
by
similar
plasma
levels
for
the
two
compounds.

870.7485
Bioequivalence­
Dog
MK
 
0243
benzoate/
HCL
salts
The
study
demonstrated
that
benzoate
and
HCl
salts
are
bioequivalent
after
oral
administration
in
male
beagle
dogs.

870.7600
Dermal
Absorption­
Rhesus
Monkey
MAB1a,
MK
 
244
Dermal
Absorption
was
approximated
at
1.79%
of
the
administered
dose.

Key:
MK
 
0243
=
hydrochloride
(
adduct)
or
salt
of
emamectin;
MK
 
0244
=
benzoic
acid
(
adduct)
or
salt
of
emamectin.

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
intraspecies
differences.
As
explained
below
in
Unit
III.
D.
3,
EPA
determined
that
the
special
FQPA
SF
be
reduced
to
1x.
However,
EPA
also
determined
that
an
additional
3x
Modifying
Uncertainty
Factor
(
UFM)
is
required
for
application
of
the
endpoint
(
based
on
the
15
 
day
mouse
neurotoxicity
study)
to
acute­
and
shortterm
scenarios,
to
account
for
the
steepness
of
the
dose­
response
curve
and
the
severity
of
effects
at
the
LOAEL
(
death
and
neuropathology).
A
3x
UFM
was
judged
to
be
adequate
(
as
opposed
to
a
10X)
because:
(
1)
A
NOAEL
was
established
in
this
study;
(
2)
although
the
effects
of
concern
are
seen
after
repeated
dosing,
the
NOAEL
here
is
used
for
a
single
exposure
risk
assessment;
and
(
3)
the
most
sensitive
endpoint
in
the
most
sensitive
species
is
selected.
For
intermediate­
and
chronic/
long­
term
scenarios,
EPA
determined
that
a
10x
UFM
is
required
to
account
for
steepness
of
the
dose­
response
curve,
severity
of
effects
at
the
LOAEL
(
death
and
neuropathology),
and
the
use
of
a
short­
term
study
for
long­
term
risk
assessment.
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
(
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*
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
as1
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
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departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
emamectin
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
EMAMECTIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
All
populations)
NOAEL
=
0.075
mg/
kg/
day
UF
=
300
Acute
RfD
=
0.00025
mg/
kg/
day
Special
FQPA
SF
=
1
aPAD
=
acute
RfD/
FQPA
SF
=
0.00025
mg/
kg/
day
15­
day
mouse
LOAEL
=
0.1
mg/
kg/
day
based
tremors
on
day
3
of
dosing.

Chronic
Dietary
(
All
populations)
NOAEL=
0.075
mg/
kg/
day
UF
=
1,000
Chronic
RfD
=
0.000075
mg/
kg/
day
Special
FQPA
SF
=
1
cPAD
=
chronic
RfD/
FQPA
SF
=
0.000075
mg/
kg/
day
15­
day
mouse
LOAEL
=
0.1
mg/
kg/
day
based
on
moribund
sacrifices,
clinical
signs
of
neurotoxicity,
decreases
in
body
weight
and
food
consumption
and
histopathological
lesions
in
the
sciatic
nerve.

Short­
Term
Incidental
Oral
(
1
 
30
days)
Toxicological
endpoints
were
not
selected
since
there
are
no
residential
uses
at
the
present
time
and
thus
no
potential
exposure
via
this
scenario.

Intermediate­
Term
Incidental
Oral
(
1
 
6
months)
Toxicological
endpoints
were
not
selected
since
there
are
no
residential
uses
at
the
present
time
and
thus
no
potential
exposure
via
this
scenario
Short­
Term
Dermal
(
1
to
30
days)
Oral
study
NOAEL=
0.075
mg/
kg/
day
(
dermal
absorption
rate
=
1.8
%)
Occupational
LOC
for
MOE
=
300
Residential
LOC
for
MOE:
N/
A
15
 
day
mouse
LOAEL
=
0.1
mg/
kg/
day
based
on
moribund
sacrifices,
clinical
signs
of
neurotoxicity,
decreases
in
body
weight
and
food
consumption
and
histopathological
lesions
in
the
sciatic
nerve.

Intermediate­
Term
Dermal
(
1
to
6
months)
Oral
study
NOAEL=
0.075
mg/
kg/
day
(
dermal
absorption
rate
=
1.8
%)
Occupational
LOC
for
MOE
=
1,000
Residential
LOC
for
MOE:
N/
A
15
 
day
mouse
LOAEL
=
0.1
mg/
kg/
day
based
on
moribund
sacrifices,
clinical
signs
of
neurotoxicity,
decreases
in
body
weight
and
food
consumption
and
histopathological
lesions
in
the
sciatic
nerve.

Long­
Term
Dermal
(>
6
months)
Long
term
dermal
exposure
is
not
expected
and
there
are
no
residential
uses
at
the
present
time.
Therefore,
quantification
of
risk
is
not
required.

Short­
Term
Inhalation
(
1
to
30
days)
Oral
study
NOAEL=
0.075
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
Occupational
LOC
for
MOE
=
300
Residential
LOC
for
MOE:
N/
A
15­
day
mouse
LOAEL
=
0.1
mg/
kg/
day
based
on
moribund
sacrifices,
clinical
signs
of
neurotoxicity,
decreases
in
body
weight
and
food
consumption
and
histopathological
lesions
in
the
sciatic
nerve.

Intermediate­
Term
Inhalation
(
1
to
6
months)
Oral
study
NOAEL=
0.075
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
Occupational
LOC
for
MOE
=
1,000
Residential
LOC
for
MOE:
N/
A
15
 
day
mouse
LOAEL
=
0.1
mg/
kg/
day
based
on
moribund
sacrifices,
clinical
signs
of
neurotoxicity,
decreases
in
body
weight
and
food
consumption
and
histopathological
lesions
in
the
sciatic
nerve.

Long­
Term
Inhalation
(>
6
months)
Not
required;
long
term
occupational
exposure
is
not
expected
and
there
are
no
residential
uses
at
the
present
time.
Therefore,
quantification
of
risk
is
not
required.

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

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.505)
for
the
combined
residues
of
emamectin
and
its
metabolites,
in
or
on
a
variety
of
raw
agricultural
commodities
and
livestock.
Tolerances
range
from
0.002
to
0.05.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
emamectin
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
1994
 
1996
and
1998
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
highly
refined,
Tier
3,
acute
dietary
exposure
assessment
was
conducted
for
the
general
U.
S.
population
and
various
population
subgroups.
This
was
a
probabilistic
assessment
using
anticipated
residue
estimates
from
the
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Rules
and
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current
and
previously
submitted
field
trial
data
as
well
as
EPA
percent
crop
treated
(
PCT)
estimates
for
a
number
of
commodities.
PCT
estimates
used
were
1%
for
cotton
commodities;
52%
for
head
lettuce;
2.5%
for
the
subgroup
4A
(
leafy
greens);
20%
for
the
subgroup
4B
(
leaf
petioles),
the
group
5
(
Brassica
leafy
vegetables),
and
peppers;
and
11%
for
tomatoes
and
its
processing
commodities.
Anticipated
residues
were
used
for
group
5
(
Brassica
leafy
vegetables),
group
4
(
leafy
vegetables
(
except
Brassica)),
and
group
8
(
fruiting
vegetables).
The
calculation
of
anticipated
residues
for
tomatoes
(
a
representative
commodity
in
group
8)
used
the
following
approach:
For
residues
of
MAB1a
and
MAB1b
which
were
below
the
limit
of
detection
(<
LOD),
calculation
was
based
on
the
MAB1a
and
MAB1b
ratio
of
9:
1;
a
residue
value
of
0.0005
ppm
(
c
LOD)
for
MAB1a
and
a
residue
value
of
0.000055
ppm
(
1/
9
of
the
c
LOD
or
1/
18
LOD)
for
MAB1b
was
reported
in
the
assessment.
For
residues
of
L'
649
and
(
L'
599
+
L'
831),
a
residue
value
of
0.0005
ppm
(
the
c
LOD)
was
reported
if
residues
were
below
the
limit
of
detection
(<
LOD).
Anticipated
residue
levels
of
0.0003
ppm
for
milk
and
skim
milk,
and
0.0009
ppm
for
cream
were
used.
The
recommended
tolerance
level
residues
were
used
for
all
other
crops
and
meat
products.
Additionally,
default
DEEM
 
(
version
7.76)
concentration
factors
were
used
when
necessary.
The
acute
dietary
exposure
estimates
are
below
EPA's
level
of
concern
(<
100%
aPAD)
at
the
99.9th
exposure
percentile
for
the
general
U.
S.
population
(
29%
of
the
aPAD)
and
all
other
population
subgroups.
The
most
highly
exposed
population
subgroup
is
children
3
 
5
years
old,
at
58%
of
the
aPAD.
The
acute
assessment
was
highly
refined,
however,
inclusion
of
additional
PCT
data
and
modified
concentration/
processing
factors
could
aid
in
further
refining
the
acute
dietary
assessment.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food­
form
(
e.
g.,
orange
or
orange
juice)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food­
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food­
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
Exposure
is
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.
A
somewhat
refined
Tier
2
chronic
dietary
exposure
assessment
was
conducted
for
the
general
U.
S.
population
and
various
population
subgroups.
The
assumptions
of
the
assessment
were
tolerance
level
residues
for
all
commodities
except
milk
(
for
which
anticipated
residue
estimates
were
used),
and
PCT
estimates
for
a
number
of
commodities.
PCT
estimates
used
were
0.4%
for
cotton
commodities;
26%
for
head
lettuce;
1.5%
for
the
subgroup
4A
(
leafy
greens);
10%
for
the
subgroup
4B
(
leaf
petioles),
the
group
5
(
Brassica
leafy
vegetables),
and
peppers;
and
6%
for
tomatoes
and
its
processing
commodities.
Anticipated
residue
levels
of
0.0003
ppm
for
milk
and
skim
milk,
and
0.0009
ppm
for
cream
were
used.
The
recommended
tolerance
level
residues
were
used
for
all
other
crops
and
meat
products.
Additionally,
default
DEEM
 
(
version
7.76)
concentration
factors
were
used
when
necessary.
The
chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
(
19%
of
the
cPAD)
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
is
children
1
 
2
years
old,
at
34%
of
the
cPAD.
The
chronic
assessment
was
somewhat
refined;
inclusion
of
ARs,
additional
PCT
information,
and
modified
concentration/
processing
factors
would
further
refine
the
chronic
dietary
assessment.
iii.
Cancer.
Emamectin
is
classified
as
a
``
not
likely''
human
carcinogen
based
on
the
lack
of
evidence
of
carcinogenicity
in
male
and
female
rats
or
male
and
female
mice
at
doses
that
were
judged
to
be
adequate
to
assess
the
carcinogenic
potential
of
the
chemical.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
PCT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
used
PCT
information
as
detailed
above
under
Unit
III.
C.
1.
i
and
III.
C.
1.
ii
Different
PCTs
and
anticipated
residues
were
used
for
the
acute
versus
the
chronic
dietary
risk
from
food
and
feed
uses
as
explained
in
these
units.
The
Agency
believes
that
the
three
conditions
listed
in
Unit
III.
C.
1.
iv
have
been
met.
With
respect
to
Condition
1,
PCT
estimates
for
existing
registrations
are
derived
from
Federal
and
private
market
survey
data,
which
are
reliable
and
have
a
valid
basis.
EPA
uses
a
weighted
average
PCT
for
chronic
dietary
exposure
estimates.
This
weighted
average
PCT
figure
is
derived
by
averaging
State­
level
data
for
a
period
of
up
to
10
years,
and
weighting
for
the
more
robust
and
recent
data.
A
weighted
average
of
the
PCT
reasonably
represents
a
person's
dietary
exposure
over
a
lifetime,
and
is
unlikely
to
underestimate
exposure
to
an
individual
because
of
the
fact
that
pesticide
use
patterns
(
both
regionally
and
nationally)
tend
to
change
continuously
over
time,
such
that
an
individual
is
unlikely
to
be
exposed
to
more
than
the
average
PCT
over
a
lifetime.
For
acute
dietary
exposure
estimates,
EPA
uses
an
estimated
maximum
PCT.
The
exposure
estimates
resulting
from
this
approach
reasonably
represent
the
highest
levels
to
which
an
individual
could
be
exposed,
and
are
unlikely
to
underestimate
an
individual's
acute
dietary
exposure.
For
new
uses,
PCT
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131
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July
9,
2003
/
Rules
and
Regulations
estimates
are
based
on
the
use
of
existing
alternative
insecticides
against
insects
that
emmamectin
will
control.
The
Agency
is
reasonably
certain
that
the
percentage
of
the
food
treated
is
not
likely
to
be
an
underestimation.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
Other
than
the
data
available
through
national
food
consumption
surveys,
EPA
does
not
have
available
information
on
the
regional
consumption
of
food
to
which
emamectin
may
be
applied
in
a
particular
area.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
emamectin
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
emamectin.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
screening
concentration
in
ground
water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screeninglevel
assessment
for
surface
water
EPA
will
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
high­
end
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
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
emamectin
they
are
further
discussed
in
the
aggregate
risk
Unit
III.
E.
Refined
(
Tier
II)
surface
water
concentrations
were
developed
for
emamectin
and
its
metabolites
with
the
PRZM/
EXAMS
model,
using
an
index
reservoir
scenario
for
the
aerial
and
ground
applications
of
emamectin
on
cotton.
The
model
assumes
that
emamectin
is
applied
at
the
maximum
label
rate
(
0.015
lb
active
ingredient/
acre
with
a
maximum
of
0.09
lb
active
ingredient/
acre/
season
for
the
dispersable
granule;
and
0.016
lb
active
ingredient/
acre
with
a
maximum
of
0.064
lb
active
ingredient/
acre/
season
for
the
emulsifiable
concentrate).
The
results
indicate
that
emamectin
and
its
metabolites
have
a
very
low
potential
to
reach
surface
waters
as
dissolved
species.
However,
emamectin
does
have
the
potential
to
reach
surface
water
bodies
through
erosion
of
soil
particles
to
which
the
compound
is
sorbed.
One
percent
of
the
application
rate
is
assumed
to
drift
from
the
application
site
during
ground
application.
For
the
additional
proposed
aerial
application,
5%
of
the
application
rate
is
assumed
to
drift
from
the
application
site
to
water
bodies.
Surface
water
and
ground
water
EECs
are
based
on
the
PRZM/
EXAMS
and
SCI­
GROW
models
respectively.
The
EECs
of
emamectin
for
acute
exposure
are
estimated
to
be
0.298
parts
per
billion
(
ppb)
for
surface
water
from
aerial
application
and
0.293
ppb
for
surface
water
from
ground
application.
The
EEC
for
chronic
exposure
is
estimated
to
be
0.080
ppb
for
surface
water.
Ground
water
EECs
are
based
on
the
Tier
I
SCI­
GROW
model.
The
EEC
of
emamectin
for
both
acute
and
chronic
exposure
is
estimated
to
be
0.006
ppb
for
ground
water.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
preamble
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).
Emamectin
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
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
emamectin
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,
emamectin
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
emamectin
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
ten­
fold
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.

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Rules
and
Regulations
2.
Prenatal
and
postnatal
sensitivity.
EPA
concludedthat
there
is
low
concern,
and
no
residual
uncertainty,
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
emamectin,
based
on
the
following:
i.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
and
rabbit
fetuses
to
in
utero
exposure
in
developmental
studies.
There
is
no
quantitative
evidence
of
increased
susceptibility
of
rat
offspring
in
the
two
generation
reproduction
study,
however,
an
increase
in
qualitative
susceptibility
was
determined.
EPA
determined
that
the
concern
is
low
because:
(
a)
There
was
a
clear
NOAEL
for
offspring
toxicity.
(
b)
Effects
unique
to
offspring
(
decreased
fertility
in
F1
adults,
and
clinical
signs
(
tremors
and
hind
limb
extensions
during
and
following
lactation))
were
seen
at
the
same
dose
that
caused
parental
systemic
toxicity
(
decreased
body
weight
gain
and
histopathological
lesions
in
the
brain
and
spinal
cord).
(
c)
The
decreased
fertility
seen
in
F1
adults
may
have
been
due
to
histopathological
lesions
in
the
brain
and
central
nervous
system
(
seen
in
both
F0
and
F1
generations),
rather
than
due
to
a
direct
effect
on
the
reproductive
system.
ii.
There
is
evidence
of
increased
qualitative
and
quantitative
susceptibility
in
the
rat
developmental
neurotoxicity
study,
but
EPA
determined
that
the
concern
is
low
because:
Although
multiple
offsping
effects
(
including
decreased
pup
body
weight,
head
and
body
tremors,
hind
limb
extension
and
splay,
changes
in
motor
activity
and
auditory
startle)
were
seen
at
the
highest
dose,
and
no
maternal
effects
were
seen
at
any
dose,
there
was
a
clear
NOAEL
for
offspring
toxicity
at
the
low
dose,
and
the
offspring
LOAEL
(
at
the
mid
dose)
is
based
on
a
single
effect
seen
on
only
one
day
(
decreased
motor
activity
on
PND
17)
and
no
other
offspring
toxicity
was
seen
at
the
LOAEL.
3.
Conclusion.
EPA
concluded
that
the
toxicology
database
was
complete
for
FQPA
purposes
and
that
there
are
no
residual
uncertainties
for
pre­/
post­
natal
toxicity.
Based
on
the
quality
of
the
data,
EPA
determined
that
the
special
FQPA
SF
should
be
reduced
to
1x.
However,
as
explained
in
Unit
III.
3.
B.
of
this
preamble,
EPA
determined
that
an
additional
3x
or
10x
modifying
uncertainty
factor
should
be
used
for
short­
term
or
intermediate­
term
exposure,
respectively.
The
recommendation
for
the
1x
FQPA
SF
is
based
on
the
following:
 
The
toxicological
database
is
complete
for
FQPA
assessment.
 
The
acute
dietary
food
exposure
assessment
utilizes
anticipated
residue
estimates
based
on
carefully
reviewed
field
trial
data
and
PCT
data
verified
by
EPA
for
several
commodities
(
100%
crop
treated
was
assumed
for
remaining
commodities).
By
using
the
99.9th
percentile
exposure
values
for
comparison
to
the
aPAD,
actual
risks
are
not
likely
to
be
underestimated.
 
The
chronic
dietary
food
exposure
assessment
utilizes
tolerance
level
residue
estimates
and
PCT
data
verified
by
EPA
for
several
commodities
(
100%
crop
treated
was
assumed
for
remaining
commodities).
This
assessment
is
somewhat
refined
and
based
on
reliable
data
that
is
not
likely
to
underestimate
exposure/
risk.
 
The
dietary
drinking
water
assessment
utilizes
water
concentration
values
generated
by
model
and
associated
modeling
parameters
which
are
designed
to
provide
conservative,
health
protective,
high­
end
estimates
of
water
concentrations
which
will
not
likely
be
exceeded.
 
There
are
no
proposed
or
existing
residential
uses
for
emamectin.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
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
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
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,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
(
at
the
99.9th
percentile)
from
food
to
emamectin
will
occupy
29%
of
the
aPAD
for
the
U.
S.
population,
23%
of
the
aPAD
for
females
13
years
and
older,
51%
of
the
aPAD
for
all
infants
(<
1
year
old)
and
58%
of
the
aPAD
for
children
3
 
5
years
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
emamectin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
the
following
Table
3:

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Vol.
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131
/
Wednesday,
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9,
2003
/
Rules
and
Regulations
TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
EMAMECTIN
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

U.
S.
Population
0.00025
29
0.298
0.006
6.2
All
infants
(<
1
year
old)
0.00025
51
0.298
0.006
1.2
Children
(
1
 
2
years
old)
0.00025
50
0.298
0.006
1.3
Children
(
3
 
5
years
old)
0.00025
58
0.298
0.006
1.0
Children
(
6
 
12
years
old)
0.00025
36
0.298
0.006
1.6
Youth
(
13
 
19
years
old)
0.00025
27
0.298
0.006
6.4
Adults
(
20
 
49
years
old)
0.00025
20
0.298
0.006
7.0
Females
(
13
 
49
years
old)
0.00025
23
0.298
0.006
5.8
Adults
(
50+
years
old)
0.00025
22
0.298
0.006
6.9
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
emamectin
from
food
will
utilize
19%
of
the
cPAD
for
the
U.
S.
population,
17%
of
the
cPAD
for
females
13
years
and
older,
9%
of
the
cPAD
for
all
infants
(<
1
year
old)
and
34%
of
the
cPAD
for
children
1
 
2
years
old.
There
are
no
residential
uses
for
emamectin
that
result
in
chronic
residential
exposure
to
emamectin.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
emamectin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
4:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
EMAMECTIN
Population
Subgroup
cPAD
(
mg/
kg)
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.000075
19
0.080
0.006
2.1
All
infants
(<
1
year
old)
0.000075
9
0.080
0.006
0.68
Children
(
1
 
2
years
old)
0.000075
34
0.080
0.006
0.49
Children
(
3
 
5
years
old)
0.000075
31
0.080
0.006
0.52
Children
(
6
 
12
years
old)
0.000075
23
0.080
0.006
0.58
Youth
(
13
 
19
years
old)
0.000075
17
0.080
0.006
2.2
Adults
(
20
 
49
years
old)
0.000075
17
0.080
0.006
2.2
Females
(
13
 
49
years
old)
0.000075
17
0.080
0.006
1.9
Adults
(
50+
years
old)
0.000075
16
0.080
0.006
2.2
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).
Emamectin
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Emamectin
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Emamectin
is
classified
as
a
``
not
likely''
human
carcinogen
based
on
the
lack
of
evidence
of
carcinogenicity
in
male
and
female
rats
or
male
and
female
mice
at
doses
that
were
judged
to
be
adequate
to
assess
the
carcinogenic
potential
of
the
chemical.
Therefore,
EPA
does
not
expect
it
to
pose
a
cancer
risk.
As
a
result,
a
quantitative
cancer
dietary
exposure
analysis
was
not
performed.
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
emamectin
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
An
analytical
method
(
HPLCfluorescence
for
the
enforcement
of
tolerances
for
residues
of
emamectin
and
its
metabolites
in/
on
plant
commodities
has
been
validated
by
EPA
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Rules
and
Regulations
and
submitted
to
the
FDA
for
inclusion
in
the
Pesticide
Analytical
Manual
(
PAM)
Vol.
II.
In
addition,
an
analytical
method
(
HPLC­
fluorescence)
for
the
enforcement
of
tolerances
for
residues
of
emamectin
and
its
metabolites
in/
on
ruminant
commodities
has
been
submitted
to
EPA
for
review.
The
ruminant
method
has
been
validated
by
an
independent
laboratory
but
EPA
validation
is
required
as
a
condition
of
registration.

B.
International
Residue
Limits
There
are
currently
no
Codex,
Canadian,
or
Mexican
maximum
residue
limits
on
emamectin
or
its
metabolites.

C.
Conditions
The
following
studies
must
be
submitted
as
conditions
for
product
registrations
related
to
these
tolerances:
A
storage
stability
study
for
cotton
seed,
gin
byproducts,
and
processed
commodities
which
reflect
the
storage
intervals
and
conditions
of
the
submitted
field
trial
and
processing
studies;
additional
storage
stability
studies
to
support
19
month
storage
intervals
for
bell
pepper
and
tomatoes;
a
new
tomato
processing
study
with
tomatoes
treated
at
an
exaggerated
rate
(
up
to
5x
the
maximum
proposed
seasonal
application
rate);
three
additional
spinach
field
trials
conducted
in
Regions
X,
VI,
and
II
(
one
study
each)
based
on
OPPTS
Guidelines
860.1500;
and
a
28
 
day
inhalation
study
using
the
CF
 
1
mouse.
In
addition,
a
successful
method
validation
by
EPA
is
required
for
the
high
performance
liquid
chromatography­
fluorescence
method
submitted
for
residues
in
ruminant
commodities;
the
registrant
is
required
to
make
any
necessary
modifications
resulting
from
the
EPA
method
review.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
combined
residues
of
emamectin,
(
a
mixture
of
a
minimum
of
90%
4 ­
epimethylamino
4 ­
deoxyavermectin
B1a
and
maximum
of
10%
4 ­
epimethylamino
4 ­
deoxyavermectin
B1b)
and
its
metabolites
8,9­
isomer
of
the
B1a
and
B1b
component
of
the
parent
(
8,9­
ZMA),
or
4 ­
deoxy­
4 ­
epi­
aminoavermectin
B1a
and
4 ­
deoxy­
4 ­
epiamino
avermectin
B1b;
4 ­
deoxy­
4 ­
epiamino
avermectin
B1a
(
AB1a);
4 ­
deoxy­
4 ­
epi­(
N­
formyl­
N­
methyl)
aminoavermectin
(
MFB1a);
and
4 ­
deoxy­
4 ­
epi­(
N­
formyl)
amino­
avermectin
B1a
(
FAB1a),
in
or
on
Brassica
leafy
vegetables
(
crop
group
5)
at
0.05
ppm;
turnip
greens
at
0.05
ppm;
cotton,
undelinted
seed
at
0.025
ppm;
cotton
gin
byproduct
at
0.05
ppm;
leafy
vegetables
(
except
Brassica)
(
crop
group
4)
at
0.10
ppm;
fruiting
vegetables
(
crop
group
8)
at
0.02
ppm;
and
tomato
paste
at
0.15
ppm.
In
addition,
tolerances
are
established
for
indirect
or
inadvertent
combined
residues
of
emamectin
(
MAB1a
+
MAB1b
isomers)
and
the
associated
8,9­
Z
isomers
(
8,9­
ZB1a
+
8,9­
ZB1b)
in
or
on
milk
and
fat
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.003
ppm;
meat
byproducts,
except
liver,
of
cattle,
goats,
hogs,
horses
,
and
sheep
at
0.005
ppm;
liver
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.020
ppm;
and
meat
of
cattle,
goat,
hogs,
horses,
and
sheep
at
0.002
ppm.
Note
that
the
tolerance
expression
in
40
CFR
180.505
is
being
changed
from
emamectin
benzoate
to
emamectin
since
the
enforcement
method,
Method
244
 
92
 
3,
Revision
1,
analyzes
residues
of
emamectin
MAB1
isomers
(
not
emamectin
benzoate),
8,9­
ZMA,
AB1a,
MFB1a,
and
FAB1a
in/
on
crops.

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
 
0220
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
September
8,
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
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/
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9,
2003
/
Rules
and
Regulations
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
 
0220,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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

VII.
Statutory
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:
June
30,
2003.
Debra
Edwards,
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.

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/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Rules
and
Regulations

2.
Section
180.505
is
revised
to
read
as
follows:

§
180.505
Emamectin;
tolerances
for
residues.
(
a)
General.
Tolerances
are
established
for
the
combined
residues
of
emamectin,
(
a
mixture
of
a
minimum
of
90%
4 ­
epi­
methylamino­
4 ­
deoxyavermectin
B1a
and
maximum
of
10%
4 ­
epi­
methylamino­
4 ­
deoxyavermectin
B1b)
and
its
metabolites
8,9­
isomer
of
the
B1a
and
B1b
component
of
the
parent
(
8,9­
ZMA),
or
4 ­
deoxy­
4 ­
epi­
amino­
avermectin
B1a
and
4 ­
deoxy­
4 ­
epi­
amino­
avermectin
B1b;
4 ­
deoxy­
4 ­
epi­
amino
avermectin
B1a
(
AB1a);
4 ­
deoxy­
4 ­
epi­(
N­
formyl­
Nmethyl
amino­
avermectin
(
MFB1a);
and
4 ­
deoxy­
4 ­
epi­(
N­
formyl)
aminoavermectin
B1a
(
FAB1a),
in
or
on
the
following
commodities:

Commodity
Parts
per
million
Cotton,
gin
byproduct
...............
0.050
Cotton,
undelinted
seed
...........
0.025
Tomato,
paste
...........................
0.150
Turnip,
greens
..........................
0.050
Vegetable,
Brassica,
leafy,
group
5
..................................
0.050
Vegetable,
fruiting,
group
8
......
0.020
Vegetable,
leafy,
except
Brassica
group
4
.........................
0.100
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
and
inadvertant
residues.
Tolerances
are
established
for
indirect
or
inadvertent
combined
residues
of
emamectin
(
MAB1a
+
MAB1b
isomers)
and
the
associated
8,9­
Z
isomers
(
8,9­
ZB1a
+
8,9­
ZB1b)
in
or
on
the
following
commodities
when
present
therein
as
a
result
of
the
application
of
emamectin
to
crops
listed
in
the
table
to
paragraph
(
a)
of
this
section:

Commodity
Parts
per
million
Cattle,
fat
..................................
0.003
Cattle,
liver
................................
0.020
Cattle,
meat
..............................
0.002
Cattle,
meat
byproducts
(
except
liver)
......................................
0.005
Cattle,
milk
................................
0.003
Goats,
fat
..................................
0.003
Goats,
liver
...............................
0.020
Goats,
meat
..............................
0.002
Goats,
meat
byproducts
(
except
liver)
..............................
0.005
Goats,
milk
................................
0.003
Hogs,
fat
...................................
0.003
Hogs,
liver
.................................
0.020
Hogs,
meat
...............................
0.002
Hogs,
meat
byproducts
(
except
liver)
......................................
0.005
Hogs,
milk
.................................
0.003
Horses,
fat
................................
0.003
Commodity
Parts
per
million
Horses,
liver
..............................
0.020
Horses,
meat
............................
0.002
Horses,
meat
byproducts
(
except
liver)
..............................
0.005
Horses,
milk
..............................
0.003
Sheep,
fat
.................................
0.003
Sheep,
liver
...............................
0.020
Sheep,
meat
.............................
0.002
Sheep,
meat
byproducts
(
except
liver)
..............................
0.005
Sheep,
milk
...............................
0.003
[
FR
Doc.
03
 
17212
Filed
7
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0134;
FRL
 
7303
 
6]

Diallyl
Sulfides;
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
diallyl
sulfides
(
DADs)
in/
on
garlic,
leeks,
onions,
and
shallots.
Platte
Chemical
Company
submitted
a
petition
to
EPA
under
section
408(
d)(
1)(
B)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
DADs
in/
on
garlic,
leeks,
onions,
and
shallots.
DATES:
This
regulation
is
effective
July
9,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0134,
must
be
received
on
or
before
September
8,
2003.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
IX.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Driss
Benmhend,
c/
o
Product
Manager
(
PM)
90,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9525;
e­
mail
address:
Benmhend.
driss@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
 
0134.
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://

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