60152
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
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
FFDCA
section
408(
n)(
4).
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.

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

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

Dated:
September
11,
2002.
James
Jones,
Acting
Director,
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
180.1222
is
added
to
subpart
D
to
read
as
follows:

§
180.1222
Sucrose
octanoate
esters;
exemption
from
the
requirement
of
a
tolerance.
An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
sucrose
octanoate
esters
[(
a
Dglucopyranosyl
b
­D­
fructofuranosyloctanoate
mono­,
di­,
and
triesters
of
sucrose
octanoate]
in
or
on
all
food
commodities
when
used
in
accordance
with
good
agricultural
practices.
[FR
Doc.
02–
24224
Filed
9–
24–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0235;
FRL–
7198–
4]

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

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
clopyralid
in
or
on
certain
raw
agricultural
commodities.
Interregional
Research
Project
Number
4
(IR­
4)
and
Dow
Agro
Sciences
LLC
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
DATES:
This
regulation
is
effective
September
25,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP–
2002–
0235,
must
be
received
on
or
before
November
25,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP–
2002–
0235
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Joanne
I.
Miller,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
703
305–
6224;
and
e­
mail
address:
miller.
joanne@
epamail.
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:

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
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Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP–
2002–
0235.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
ailable
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
14,
2002
(67
FR
52990)
(FRL–
7191–
7),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(FQPA)
(Public
Law
104–
170),
announcing
the
filing
of
pesticide
petitions
(PP
1E6227,
1E6241,
1E6283,
1E6291,
1E6320,
1E6329,
1E6333,
1E6334,
1E6335,
1E6399,
and
1E6340
)
by
the
Interregional
Research
Project
Number
4
(IR­
4),
P.
O.
Box
231,
Rutgers
University,
New
Brunswick,
NJ
08903
and
PP
4F4379
from
Dow
Agro
Sciences
LLC,
Indianapolis,
IN
46268.
This
notice
included
a
summary
of
the
petition
prepared
by
Dow
Agro
Sciences
LLC,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.431
be
amended
by
establishing
tolerances
for
residues
of
the
herbicide
clopyralid,
3,6­
dichloro­
2­
pyridinecarboxylic
acid,
in
or
on
the
following
commodities:
Flax
seed
at
3.0
part
per
million
(ppm);
strawberry
at
1.0
ppm;
hop,
dried
cones
at
5.0
ppm;
rapeseed
seed,
rapeseed
forage,
canola
seed,
mustard
seed,
and
crambe
seed
at
3
ppm,
and
canola
meat
at
6.0
ppm;
spinach
at
5.0
ppm;
stone
fruit
group
at
0.5
ppm;
garden
beet
tops
at
3.0
ppm
and
garden
beet
roots
at
4.0
ppm;
mustard
greens
at
5.0
ppm;
turnip
roots
at
1.0
ppm
and
turnip
greens
at
4.0
ppm;
cranberry
at
4
ppm;
sweet
corn,
kernel
plus
cob
with
husks
removed
at
1.0
ppm,
sweet
corn
forage
at
7.0
ppm,
sweet
corn
stover
at
10.0
ppm,
pop
corn
grain
at
1.0
ppm,
pop
corn
stover
at
10.0
ppm,
liver
of
cattle,
goat,
horse,
and
sheep
at
3.0
ppm,
meat
byproducts,
except
liver,
of
cattle,
goat,
horse
and
sheep
at
36.0
ppm,
and
milk
at
0.2
ppm;
and
the
brassica,
head
and
stem,
subgroup
at
2.0
ppm.
EPA
is
editorially
correcting
the
tolerance
expressions
to
read
canola
meal
and
turnip,
tops.
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)
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)
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue....
''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
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),
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),
for
a
tolerance
for
residues
of
clopyralid
on
strawberry
at
1.0
ppm;
hop,
dried
cones,
at
5.0
ppm;
rapeseed
seed,
rapeseed
forage,
mustard
seed,
and
crambe
seed
at
3
ppm,
canola
meal
and
flax
meal
at
6.0
ppm;
spinach
at
5.0
ppm;
stone
fruit
group
at
0.5
ppm;
prunes
at
1.5
ppm,
garden
beet
tops
at
3.0
ppm
and
garden
beet
roots
at
4.0
ppm;
mustard
greens
at
5.0
ppm;
turnip
roots
at
1.0
ppm
and
turnip
tops
at
4.0
ppm;
cranberry
at
4.0
ppm;
sweet
corn,
kernel
plus
cob
with
husks
removed
at
1.0
ppm,
sweet
corn
forage
at
7.0
ppm,
sweet
corn
stover
at
10.0
ppm,
pop
corn
grain
at
1.0
ppm,
pop
corn
stover
at
10.0
ppm,
liver
of
cattle,
goat,
horse,
and
sheep
at
3.0
ppm,
meat
byproducts,
except
liver,
of
cattle,
goat,
horse
and
sheep
at
36.0
ppm,
and
milk
at
0.2
ppm;
and
the
Brassica,
head
and
stem,
subgroup
at
2.0
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
clopyralid
are
discussed
in
the
following
Table
1
and
Table
2
as
well
as
the
no
observed
adverse
effect
level
(NOAEL)
and
the
lowest
observed
adverse
effect
level
(LOAEL)
from
the
toxicity
studies
reviewed.

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Vol.
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186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
OF
CLOPYRALID
Guideline
No.
Study
Type
Results
870.3100
90–
Day
oral
toxicity
in
mice
NOAEL
=
2,000
mg/
kg/
day
in
both
sexes.
LOAEL
=
5,000
mg/
kg/
day
in
both
sexes
based
on
decreased
body
weight
in
both
sexes.

870.3200
21/
28–
Day
dermal
toxicity
in
rabbits
NOAEL
=
1,000
mg/
kg/
day
for
both
sexes.

870.3700
Prenatal
developmental
toxicity
in
rats
Maternal
NOAEL
=
75
mg/
kg/
day
LOAEL
=
250
mg/
kg/
day
based
on
mortality,
reduced
body
weight
gains
and
reduced
food
consumption.
Developmental
NOAEL
=
250
mg/
kg/
day
highest
dose
tested
(HDT).

870.3700
Prenatal
developmental
toxicity
in
rabbits
Maternal
NOAEL
=
110
mg/
kg/
day.
LOAEL
=
250
mg
/kg/
day
based
on
mortality,
clinical
signs,
decreased
body
weight
gains,
and
lesions
of
the
gastric
mucosa.
Developmental
NOAEL
=
110
mg/
kg/
day.
LOAEL
=
250
mg/
kg/
day
based
on
decreased
fetal
body
weight
and
hydrocephalus.

870.3800
Reproduction
and
fertility
effects
in
rats
Systemic
NOAEL
=
500
mg/
kg/
day
for
males
and
females
LOAEL
=
1,500
mg/
kg/
day
for
males
and
females
based
on
decreased
body
weights,
decreased
weight
gain,
and
decreased
food
consumption
in
both
sexes
and
slight
focal
hyperkeratotic
changes
in
gastric
squamous
mucosa
in
males.
Reproductive/
Offspring
NOAEL
=
500
mg/
kg/
day
LOAEL
=
1,500
mg/
kg/
day
for
males
and
females
based
on
reduced
pup
weights
in
males
and
increased
relative
liver
weight
in
pups
of
both
sexes.

870.4100
Chronic
toxicity
dogs
NOAEL
=
100
mg/
kg/
day
in
males
and
females.
LOAEL
=
320
mg/
kg/
day
based
upon
reduction
in
hematological
parameters
in
both
sexes,
increased
absolute
liver
weight
in
males,
and
vacuolated
adrenal
cortical
cells
in
females.

870.4200
Carcinogenicity
mice
NOAEL
=
500
mg/
kg/
day
and
 
2,000
mg/
kg/
day
in
females.
LOAEL
=
2,000
mg/
kg/
day
in
males
based
on
decreased
body
weight,
body
weight
gains,
and
food
efficiency.
No
evidence
of
carcinogenicity.

870.4300
Combined
Chronic
Toxicity/
Carcinogenicity
in
rats
NOAEL
=
15
mg/
kg/
day.
LOAEL
=
150
mg/
kg/
day
based
on
epithelial
hyperplasia
and
thickening
of
the
limiting
ridge
of
the
stomach
in
both
sexes.
No
evidence
of
carcinogenicity.

870.5300
In
vitro
and
in
vivo
host
mediated
assay
in
bacteria
No
evidence
of
induced
mutant
colonies
over
background
in
Salmonella
strains
TA
1,530
bacteria
and
G­
46
and
Saccharomyces
strain
D­
3
870.5385
Bone
marrow
chromosome
aberrations
assay
There
was
no
significant
increase
in
the
frequency
of
chromosome
aberrations
in
bone
marrow
at
any
dose
tested.

870.5550
In
vitro
unscheduled
DNA
synthesis
assay
There
was
no
evidence
of
unscheduled
DNA
synthesis
in
initial
or
supplementary
assays

870.5450
Dominant
lethal
assay
in
rats.
No
evidence
of
treatment
related
resorptions
up
to
400
mg/
kg/
day
for
5
days.

870.7485
Metabolism
in
rats
Rapidly
absorbed
and
excreted
mainly
in
the
urine.
Parent
compound
only
is
detected
in
the
excreta.

B.
Toxicological
Endpoints
The
dose
at
which
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
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
Safety
Factor.
For
non­
dietary
risk
assessments
(other
than
cancer)
the
UF
is
used
to
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Rules
and
Regulations
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
as
1
x
10
­6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
clopyralid
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:

TABLE
2.—
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CLOPYRALID
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
(General
population
including
infants
and
children)
NOAEL
=
75
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.75
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD/
FQPA
SF
=
0.75
mg/
kg/
day
Developmental
Toxicity
Study
­
rat
Maternal
LOAEL
=
250
mg
ai/
kg/
day
based
on
decreased
weight
gain
during
gestation
days
6–
9
Chronic
Dietary
(All
populations)
NOAEL
=
15
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.15
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD/
FQPA
SF
=
0.15
mg/
kg/
day
2–
Year
Chronic
Toxicity/
Carcinogenicity
Study
­
rat
LOAEL
=
150
mg
ai/
kg/
day
based
on
increased
epithelial
hyperplasia
and
thickening
of
the
limiting
ridge
of
the
stomach
in
both
sexes
Short­
Term
Incidental
Oral
NOAEL
=
75
mg/
kg/
day
LOC
for
MOE
=
100
Developmental
Toxicity
Study
­
rat
Maternal
LOAEL
=
250
mg
ai/
kg/
day
based
on
decreased
weight
gain
during
gestation
days
6–
9
Intermediate
Term
Incidental
Oral
NOAEL
=
15
mg/
kg/
day
LOC
for
MOE
=
100
2–
Year
Chronic
Toxicity/
Carcinogenicity
Study
­
rat
LOAEL
=
150
mg
ai/
kg/
day
based
on
increased
epithelial
hyperplasia
and
thickening
of
the
limiting
ridge
of
the
stomach
in
both
sexes
Short–
Term
(1–
7
days)
and
Intermediate
Term
(1
week
­
several
months)
Dermal
None
No
systemic
toxicity
was
seen
at
the
limit
dose
(1,000
mg/
kg/
day)
in
the
21–
day
dermal
toxicity
study
in
rabbits.
This
risk
assessment
is
not
required
Not
Applicable
(N/
A)

Short–
Term
(1–
7
days)
Inhalation
NOAEL
=
75
mg/
kg/
day
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
Developmental
Toxicity
Study
­
rat
Maternal
LOAEL
=
250
mg
ai/
kg/
day
based
on
decreased
body
weight
gain
Cancer
(Oral,
dermal,
inhalation)
Not
likely
N/
A
Acceptable
oral
rat
and
mouse
carcinogenicity
studies;
no
evidence
of
carcinogenic
or
mutagenic
potential.

*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
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
180.431)
for
the
residues
of
clopyralid,
in
or
on
a
variety
of
raw
agricultural
commodities.
Established,
proposed
and
increased
tolerances
for
clopyralid
are
adequate
for
any
expected
secondary
residues
in
meat,
milk,
poultry
and/
or
eggs.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
clopyralid
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.
In
conducting
this
acute
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(DEEM
TM
)
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.
Residue
levels
are
at
the
recommended
tolerances
with
the
exception
of
sugar
beets.
The
empirical
processing
factor
of
0.1x
was
used
for
sugar­
beet
representing
the
10–
fold
reduction
in
residues
for
refined
sugar.
One
hundred
percent
of
all
of
the
crops
are
treated
with
clopyralid.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
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Vol.
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186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
(DEEM
TM
)
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.
Residue
levels
are
at
the
recommended
tolerances
with
the
exception
of
sugar
beets.
The
empirical
processing
factor
of
0.1x
was
used
for
sugar­
beet
representing
the
10­
fold
reduction
in
residues
for
refined
sugar.
One
hundred
percent
of
all
of
the
crops
are
treated
with
clopyralid.
iii.
Cancer.
Acceptable
oral
rat
and
mouse
carcinogenicity
studies
show
no
evidence
of
carcinogenic
or
mutagenic
potential.
Clopyralid
is
classified
as
not
likely
to
be
a
human
carcinogen.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
clopyralid
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
clopyralid.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(GENEEC)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCI­
GROW,
which
predicts
pesticide
concentrations
in
groundwater.
In
general,
EPA
will
use
GENEEC
(a
tier
1
model)
before
using
PRZM/
EXAMS
(a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
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
clopyralid
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E
of
this
document.
Based
on
the
FIRST
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(EECs)
of
clopyralid
for
acute
exposures
are
estimated
to
be
46
parts
per
billion
(ppb)
for
surface
water
and
9.7
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
18
ppb
in
surface
water
and
9.7
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).
Clopyralid
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
Turf
and
ornamentals
(including
golf
courses).
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
the
75
mg/
kg/
day
NOAEL
was
used
in
the
short­
term
inhalation,
hand­
to­
mouth,
and
episodic
granular
ingestion
risk
assessments
of
the
residential
exposure.
The
intermediateterm
assessment
for
children's
hand­
tomouth
exposure
was
based
on
the
15
mg/
kg/
day
NOAEL
chosen
for
incidental
oral
exposure.
As
no
dermal
endpoint
was
selected,
a
dermal
risk
assessment
was
not
required
for
residential
exposure.
For
residential
oral
and
inhalation
risk
assessments,
the
target
margin
of
exposure
(MOE)
was
100
which
incorporates
the
removal
of
the
FQPA
Safety
Factor.
MOEs
calculated
for
residential
handler's
inhalation
exposure
and
children's
oral
exposures
were
well
above
the
target
of
100;
and
therefore,
do
not
exceed
the
Agency's
level
of
concern.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
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
clopyralid
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,
clopyralid
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
clopyralid
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.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
No
increased
quantitative
or
qualitative
susceptibility
was
seen
following
pre­
and/
or
post­
natal
exposures.
In
the
developmental
study
with
rats,
no
developmental
toxicity
was
seen
at
the
HDT
(250
mg/
kg/
day)
even
in
the
presence
of
severe
maternal
toxicity
which
manifested
as
deaths,
reduced
body
weight
gain
and
decreased
food
consumption.
In
the
two
generation
reproduction
study,
offspring
toxicity,
characterized
as
decreased
pup
weight
and
increased
liver
weights,
occurred
only
at
the
HDT
(1,500
mg/
kg/
day)
which
is
higher
than
the
Limit
Dose
(1,000
mg/
kg/
day).
These
changes
occurred
in
the
presence
of
severe
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parental
toxicity
(decreased
body
weight,
body
weight
gain,
food
consumption
and
slight
focal
hyper
keratosis
of
the
gastric
mucosa).
In
the
developmental
rabbit
study,
hydrocephalus
was
seen
in
eight
fetuses
(3/
15
litters)
only
at
the
highest
dose
tested
(250
mg/
kg/
day)
in
the
presence
of
severe
maternal
toxicity
that
manifested
as
death,
decreases
in
mean
body
weight
and
lesions
of
the
gastric
mucosa;
the
developmental
NOAEL
was
110
mg/
kg/
day.
The
available
data
indicate
that
a
developmental
neurotoxicity
study
would
have
to
be
tested
at
dose
levels
higher
than
250
mg/
kg/
day
because
no
developmental
toxicity
was
observed
in
rats
at
250
mg/
kg/
day.
In
addition,
the
offspring
NOAEL
in
the
two
generation
reproduction
study
was
500
mg/
kg/
day
with
a
LOAEL
of
1,500
mg/
kg/
day.
Therefore,
it
is
anticipated
that
in
order
to
elicit
any
fetal
nervous
system
abnormalities
in
a
developmental
neurotoxicity
study,
the
selected
dose
levels
would
have
to
be
higher
than
500
mg/
kg/
day.
Since
the
dose
level
selections
for
the
developmental
neurotoxicity
study
will
be
greater
than
500
mg/
kg/
day,
the
resultant
NOAEL
will
be
either
comparable
to,
or
higher
than
the
doses
currently
used
in
the
risk
assessment.
The
NOAEL
of
75
mg/
kg/
day
selected
for
the
acute
RfD
is
seven
times
lower
than
the
offspring
NOAEL
in
the
reproduction
study.
The
NOAEL
of
15
mg/
kg/
day
selected
for
the
chronic
RfD
and
the
residential
exposure
risk
assessments
is
thirty
three
times
lower
than
the
offspring
NOAEL
in
the
reproduction
study.
Therefore,
a
developmental
neurotoxicity
study
would
not
likely
change
the
regulatory
doses
used
for
overall
risk
assessments.
3.
Conclusion.
EPA
determined
that
an
additional
factor
to
protect
infants
and
children
was
not
appropriate.
Several
factors
influenced
this
decision
not
to
require
a
development
neurotoxicity
(DNT)
study:
i.
Although
hydrocephalus
was
observed
at
the
high
dose
in
the
developmental
rabbit
study,
it
was
seen
in
the
presence
of
severe
maternal
toxicity;
ii.
No
alterations
to
the
fetal
nervous
system
were
seen
in
the
developmental
rat
study
at
the
same
dose
(250
mg/
kg/
day);
iii.
There
was
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
in
the
two
generation
reproduction
study;
iv.
There
is
no
concern
nor
are
there
residual
uncertainties
for
pre
and/
or
post
natal
toxicity;
and
v.
Although
there
are
no
acute
or
subchronic
neurotoxicity
studies,
there
is
no
evidence
of
neurotoxicity
or
neuropathology
in
adult
animals
in
any
of
the
studies.
EPA
decided
that
the
FQPA
safety
factor
should
be
reduced
to
1
rather
than
the
statutory
default
factor
of
10
because
the
existing
toxicology
database,
which
is
complete,
revealed
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
following
in
utero
exposure
to
rats
and
rabbits
and/
or
following
prenatal/
postnatal
exposure
to
rats;
and
dietary
(food
and
drinking
water)
and
residential
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants,
children,
and/
or
women
of
childbearing
age
from
the
use
of
clopyralid.

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:
2L/
70
kg
(adult
male),
2L/
60
kg
(adult
female),
and
1L/
10
kg
(child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
clopyralid
will
occupy
4%
of
the
aPAD
for
the
U.
S.
population,
2%
of
the
aPAD
for
females
13
years
and
older,
4%
of
the
aPAD
for
all
infants
(
1
year)
and
7%
of
the
aPAD
for
children
1–
6
years.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
clopyralid
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:

TABLE
3.—
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
CLOPYRALID
Population
Subgroup
aPAD
(mg/
kg)
%
aPAD
(Food)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Acute
DWLOC
(ppb)

General
U.
S.
Population
0.75
4
46
9.7
25,000
All
Infants
(
1
year)
0.75
4
46
9.7
7,200
Children
1–
6
years
0.75
7
46
9.7
7,000
Females
13–
50
0.75
2
46
9.7
22,000
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2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
clopyralid
from
food
will
utilize
7%
of
the
cPAD
for
the
U.
S.
population,
7%
of
the
cPAD
for
all
infants
(
1
year)
and
17%
of
the
cPAD
for
children
1–
6
years.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
clopyralid
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
clopyralid
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
CLOPYRALID
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(Food)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Chronic
DWLOC
(ppb)

U.
S.
Population
0.15
7
18
9.7
4,900
All
Infants
(
1
year)
0.15
7
18
9.7
1,400
Children
1–
6
years
0.15
17
18
9.7
1,200
Females
13–
50
0.15
5
18
9.7
4,300
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).
Clopyralid
is
currently
registered
for
use
that
could
result
in
short­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
exposures
for
clopyralid.
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
7,000
(U.
S.
population,
food
and
residential),
9,600
(females
13–
50,
food
and
residential)
and
2,200
(children
1–
6
years
old,
food
and
residential).
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
shortterm
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
clopyralid
in
ground
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
the
following
Table
5:

TABLE
5.—
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
CLOPYRALID
Population
Subgroup
Aggregate
MOE
(Food
+
Residential
Aggregate
Level
of
Concern
(LOC)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Short–
Term
DWLOC
(ppb)

U.
S.
Population
7,000
100
18
9.7
26,000
Children
1–
6
years
2,200
100
18
9.7
7,200
Females
13–
50
years
9,600
100
18
9.7
22,000
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).
Clopyralid
is
currently
registered
for
use(
s)
that
could
result
in
intermediateterm
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
intermediate­
term
exposures
for
clopyralid.
Using
the
exposure
assumptions
described
in
this
unit
for
intermediateterm
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
an
aggregate
MOE
of
530
(children
1–
6
years,
food
and
residential).
This
aggregate
MOE
does
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
an
intermediate­
term
DWLOC
was
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
clopyralid
in
ground
and
surface
water.
After
calculating
the
DWLOC
and
comparing
it
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
intermediate­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
the
following
Table
6:

TABLE
6.—
AGGREGATE
RISK
ASSESSMENT
FOR
INTERMEDIATE­
TERM
EXPOSURE
TO
CLOPYRALID
Population
Subgroup
Aggregate
MOE
(Food
+
Residential
Aggregate
Level
of
Concern
(LOC)
Surface
Water
EEC
(ppb)
Ground
Water
+
EEC
(ppb)
IntermediateTerm
DWLOC
(ppb)

Children
1–
6
years
530
100
18
9.7
1,200
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5.
Aggregate
cancer
risk
for
U.
S.
population.
The
Agency
concluded
that
clopyralid
was
negative
for
carcinogenicity
potential
in
rats
and
mice
and
classified
clopyralid
as
``
not
likely''
to
be
a
human
carcinogen
according
to
EPA
Draft
Guidelines
for
Carcinogen
Risk
Assessment.
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
clopyralid
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
An
adequate
residue
analytical
method
is
available
for
enforcement
of
the
proposed
tolerances.
This
method,
ACR
75.6,
determines
clopyralid
as
the
methyl
ester
by
gas
chromatography
using
electron
capture
detection.
This
method
has
been
successfully
validated
by
EPA
and
has
been
published
in
FDA's
Pesticide
Analytical
Manual,
VolII
(PAM
II).
An
adequate
residue
analytical
method
is
also
available
for
the
enforcement
of
the
proposed
tolerance
on
animal
commodities.
This
method,
ACR
86.1,
determines
clopyralid
as
the
methyl
ester
by
gas
chromatography
using
electron
capture
detection.
This
method
has
been
successfully
validated
by
EPA
and
has
been
published
in
FDA's
Pesticide
Analytical
Manual,
VolII
(PAM
II).

B.
International
Residue
Limits
There
are
no
Codex
or
Mexican
maximum
residue
limits
(MRLs).
Canada
has
set
maximum
residue
limits
of
2.0
ppm
for
barley,
oats,
and
wheat,
7.0
ppm
for
the
milled
fractions
of
barley,
oats,
and
wheat
(excluding
flour),
1.0
ppm
for
strawberries
and
0.2
ppm
for
flax.

V.
Conclusion
Therefore,
tolerances
are
established
for
residues
of
clopyralid
on
strawberry
at
1.0
ppm;
hop,
dried
cones,
at
5.0
ppm;
rapeseed
seed,
rapeseed
forage,
mustard
seed,
and
crambe
seed
at
3.0
ppm,
canola
meal
and
flax
meal
at
6.0
ppm;
spinach
at
5.0
ppm;
stone
fruit
group
at
0.5
ppm;
prunes
at
1.5
ppm,
garden
beet
tops
at
3.0
ppm
and
garden
beet
roots
at
4.0
ppm;
mustard
greens
at
5.0
ppm;
turnip
roots
at
1.0
ppm
and
turnip
tops
at
4.0
ppm;
cranberry
at
4.0
ppm;
sweet
corn,
kernel
plus
cob
with
husks
removed
at
1.0
ppm,
sweet
corn
forage
at
7.0
ppm,
sweet
corn
stover
at
10.0
ppm,
pop
corn
grain
at
1.0
ppm,
pop
corn
stover
at
10.0
ppm,
liver
of
cattle,
goat,
horse,
and
sheep
at
3.0
ppm,
meat
byproducts,
except
liver,
of
cattle,
goat,
horse
and
sheep
at
36.0
ppm,
and
milk
at
0.2
ppm;
and
the
brassica,
head
and
stem,
subgroup
at
2.0
ppm.

VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
control
number
OPP–
2002–
0235
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
November
25,
2002.
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.
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.
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.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
2.
Mail
your
copies,
identified
by
docket
control
number
OPP–
2002–
0235,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.

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/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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

VII.
Regulatory
Assessment
Requirements
This
final
rule
establishes
a
tolerance
under
FFDCA
section
408(
d)
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
FFDCA
section
408(
d),
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
FFDCA
section
408(
n)(
4).
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.
''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.
''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
September
16,
2002.
Peter
Caulkins,
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
374.
2.
Section
180.431
is
amended
as
follows:
i.
By
alphabetically
adding
commodities
to
the
table
in
paragraph
(a);
ii.
By
removing
tolerances
for
cattle,
kidney;
goat,
kidney;
horse,
kidney
and
sheep,
kidney
in
the
table
in
paragraph
(a);
iii.
By
increasing
tolerances
for
cattle,
meat
byproducts,
except
liver;
goat,
meat
byproducts,
except
liver;
horse,
meat
byproducts,
except
liver
and
sheep,
meat
byproducts,
except
liver;
and
milk
in
the
table
in
paragraph
(a);
and
iv.
By
removing
the
text
from
paragraph
(b);
and
reserving
paragraph
(b)
with
the
heading.
The
additions
and
revisions
read
as
follows:

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60161
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
§
180.431
Clopyralid;
tolerances
for
residues.
(a)
General.
Tolerances
are
established
for
residues
of
the
herbicide
clopyralid
(3,6­
dichloro­
2­
pyridinecarboxylic
acid)
in
or
on
the
following
commodities:

Commodity
Parts
per
million
*****
Beet,
garden,
tops
..........
3.0
Beet,
garden,
roots
.........
4.0
Brassica,
head
and
stem,
subgroup
.....................
2.0
Canola,
meal
..................
6.0
Canola,
seed
..................
3.0
*****
Cattle,
liver
......................
3.0
*****
Cattle,
meat
byproducts,
except
liver
..................
36.0
*****
Corn,
pop,
grain
..............
1.0
Corn,
pop,
stover
............
10.0
Corn,
sweet,
forage
........
7.0
Corn,
sweet,
kernel
plus
cob
with
husks
removed
.........................
1.0
Corn,
sweet,
stover
........
10.0
Crambe,
seed
.................
3.0
Cranberry
........................
4.0
*****
Flax,
meal
.......................
6.0
Flax,
seed
.......................
3.0
Fruit,
stone,
group
..........
0.5
*****
Goat,
liver
.......................
3.0
*****
Goat,
meat
byproducts,
except
liver
..................
36.0
*****
Hop,
dried
cones
............
5.0
*****
Horse,
liver
.....................
3.0
*****
Horse,
meat
byproducts,
except
liver
..................
36.0
Milk
.................................
0.2
*****
Mustard,
greens
..............
5.0
Mustard,
seed
.................
3.0
*****
Plum,
prune,
dried
..........
1.5
*****
Rapeseed,
seed
.............
3.0
Rapeseed,
forage
...........
3.0
*****
Sheep,
liver
.....................
3.0
*****
Sheep,
meat
byproducts,
except
liver
..................
36.0
*****
Spinach
...........................
5.0
Strawberry
......................
1.0
*****
Turnip,
roots
...................
1.0
Turnip,
tops
.....................
4.0
*****

(b)
Section
18
emergency
exemptions.
[Reserved]
*
*
*
*
*

[FR
Doc.
02–
24232
Filed
9–
24–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
281
[FRL–
7381–
6]

Hawaii;
Final
Approval
of
State
Underground
Storage
Tank
Program
AGENCY:
Environmental
Protection
Agency.

ACTION:
Notice
of
final
determination
on
the
State
of
Hawaii's
application
for
final
approval.

SUMMARY:
The
State
of
Hawaii
has
applied
for
approval
of
its
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances
under
Subtitle
I
of
the
Resource
Conservation
and
Recovery
Act
(RCRA).
The
Environmental
Protection
Agency
(EPA)
has
reviewed
Hawaii's
application
and
has
reached
a
final
determination
that
Hawaii's
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances
satisfies
all
of
the
requirements
necessary
to
qualify
for
approval.
Thus,
the
EPA
is
granting
final
approval
to
the
State
of
Hawaii
to
operate
its
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances.

EFFECTIVE
DATE:
Final
approval
for
the
State
of
Hawaii's
Underground
Storage
Tanks
Program
shall
be
effective
on
September
30,
2002.

FOR
FURTHER
INFORMATION
CONTACT:
Mr.
Norwood
Scott,
Underground
Storage
Tanks
Program
Office,
U.
S.
EPA,
Region
9,
75
Hawthorne
Street
(WST–
8),
San
Francisco,
California
94105,
Telephone:
(415)
972–
3373.

SUPPLEMENTARY
INFORMATION:

A.
Background
Section
9004
of
the
Resource
Conservation
and
Recovery
Act
(RCRA)
authorizes
the
Environmental
Protection
Agency
(EPA)
to
approve
state
Underground
Storage
Tank
Programs
to
operate
in
the
State
in
lieu
of
the
Federal
Underground
Storage
Tank
(UST)
Program.
To
qualify
for
final
authorization,
a
state's
Program
must:
(1)
Be
``
no
less
stringent''
than
the
Federal
Program
for
the
seven
elements
set
forth
at
RCRA
Section
9004(
a)(
1)
through
(7);
and
(2)
provide
for
adequate
enforcement
of
compliance
with
the
UST
standards
of
RCRA
Section
9004(
a).
Note
that
RCRA
Sections
9005
(on
information­
gathering)
and
9006
(on
Federal
enforcement)
by
their
terms
apply
even
in
states
with
Programs
approved
by
the
EPA
under
RCRA
Section
9004.
Thus,
the
Agency
retains
its
authority
under
RCRA
Sections
9005
and
9006,
42
U.
S.
C.
6991d
and
6991e,
and
other
applicable
statutory
and
regulatory
provisions
to
undertake
inspections
and
enforcement
actions
in
approved
states.
With
respect
to
such
an
enforcement
action,
the
Agency
will
rely
on
Federal
sanctions,
Federal
inspection
authorities,
and
Federal
procedures
rather
than
the
state
authorized
analogues
to
these
provisions.
Moreover,
authorization
of
a
state
Program
is
a
prospective
action
only
and
an
authorized
state
Program
only
operates
in
lieu
of
the
Federal
Program
as
of
the
effective
date
of
the
authorization.
The
Agency
may
undertake
enforcement
of
the
Federal
requirements
for
violations
of
those
Federal
requirements
which
occurred
prior
to
the
effective
date
of
authorization
of
the
state's
Program.
In
this
case,
authorization
of
the
Hawaii
UST
Program
will
be
effective
on
September
30,
2002.
On
May
23,
2001,
the
State
of
Hawaii
submitted
an
official
application
to
obtain
final
program
approval
to
administer
the
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances.
On
October
5,
2001,
the
EPA
published
a
tentative
decision
announcing
its
intent
to
grant
Hawaii
final
approval.
Further
background
on
the
tentative
decision
to
grant
approval
appears
at
66
FR
50963–
50966,
October
5,
2001.
Along
with
the
tentative
determination,
the
EPA
announced
the
availability
of
the
application
for
public
comment
and
the
date
of
a
public
hearing
on
the
application.
The
EPA
requested
advance
notice
for
testimony
and
reserved
the
right
to
cancel
the
public
hearing
for
lack
of
public
interest.
The
hearing
was
held
at
Kawananakoa
Middle
School
in
Honolulu,
Hawaii
on
November
13,
2001.

B.
Significant
Public
Comments
and
EPA's
Responses
Written
comments
regarding
the
EPA's
approval
of
Hawaii's
Underground
Storage
Tank
Program
were
received
during
the
comment
period
from
EnviroWatch,
Inc.
Oral
comments
regarding
the
EPA's
approval
of
Hawaii's
Underground
Storage
Tank
Program
were
received
during
the
public
hearing
from
Carroll
Cox,
President
of
EnviroWatch,
Inc.,
and
Joe
Ryan,
a
resident
of
Waimanalo.
Additionally,
in
April
2001,
prior
to
publication
of
EPA's
tentative
decision
to
authorize
Hawaii's
Underground
Storage
Tank
Program,
EPA
received
a
Petition
To
Withdraw
Hawaii
Certification
and
Title
VI
Complaint
of
Discriminatory
Acts
(Petition
to
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