Document ID: EPA-HQ-OPP-2003-0135-0001
Agency: epa
Document Type: Rule
Title: Fludioxonil; Pesticide Tolerance
Posted Date: 2003-07-03T04:00Z

39846
Federal
Register
/
Vol.
68,
No.
128
/
Thursday,
July
3,
2003
/
Rules
and
Regulations
H.
Executive
Order
13211:
Actions
That
Significantly
Affect
Energy
Supply,
Distribution
or
Use
This
rule
is
not
subject
to
Executive
Order
13211,
``
Actions
that
Significantly
Affect
Energy
Supply,
Distribution,
or
Use''
(
66
FR
28355,
May
22,
2001)
because
it
is
not
a
significant
regulatory
action
under
Executive
Order
12866.

I.
National
Technology
Transfer
Advancement
Act
Section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(``
NTTAA''),
Public
Law
No.
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note)
directs
EPA
to
use
voluntary
consensus
standards
in
its
regulatory
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
and
business
practices)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
The
NTTAA
directs
EPA
to
provide
Congress,
through
OMB,
explanations
when
the
Agency
decides
not
to
use
available
and
applicable
voluntary
consensus
standards.
This
action
does
not
involve
technical
standards.
Therefore,
EPA
did
not
consider
the
use
of
any
voluntary
consensus
standards.

J.
Executive
Order
12898:
Federal
Actions
To
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
Executive
Order
12898
requires
that
each
Federal
agency
make
achieving
environmental
justice
part
of
its
mission
by
identifying
and
addressing,
as
appropriate,
disproportionately
high
and
adverse
human
health
or
environmental
effects
of
its
programs,
policies,
and
activities
on
minorities
and
low­
income
populations.
The
requirements
of
Executive
Order
12898
have
been
previously
addressed
to
the
extent
practicable
in
the
Regulatory
Impact
Analysis
(
RIA)
for
the
regional
haze
rule
(
cited
above),
particularly
in
chapters
2
and
9
of
the
RIA.
Today's
direct
final
rule
makes
no
changes
that
would
have
a
disproportionately
high
and
adverse
human
health
or
environmental
effect
on
minorities
and
low­
income
populations.

K.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
SBREFA,
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.
The
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(
a).

IV.
Statutory
Provisions
and
Legal
Authority
Statutory
authority
for
today's
direct
final
rule
comes
from
sections
169(
a)
and
169(
b)
of
the
CAA
(
42
U.
S.
C.
7545(
c)
and
(
k)).
These
sections
require
EPA
to
issue
regulations
that
will
require
States
to
revise
their
SIPs
to
ensure
that
reasonable
progress
is
made
toward
the
national
visibility
goals
specified
in
section
169(
A).

List
of
Subjects
in
40
CFR
Part
51
Environmental
protection,
Administrative
practice
and
procedure,
Air
pollution
control,
Carbon
monoxide,
Nitrogen
dioxide,
Particulate
matter,
Sulfur
oxides,
Volatile
organic
compounds.

Dated:
June
27,
2003.
Christine
Todd
Whitman,
Administrator.


For
the
reasons
set
forth
in
the
preamble,
part
51
of
title
40,
Chapter
1
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
51
 
REQUIREMENTS
FOR
PREPARATION,
ADOPTION,
AND
SUBMITTAL
OF
IMPLEMENTATION
PLANS

1.
The
authority
citation
for
part
51
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7410,
7414,
7421,
7470
 
7479,
7492,
7601,
and
7602.

Subpart
P
 
Protection
of
Visibility

2.
Section
51.309
is
amended
by
revising
paragraphs
(
b)(
6)
and
(
d)(
5)(
i),
deleting
paragraphs
(
d)(
ii)
and
(
d)(
iii),
and
renumbering
(
d)(
iv)
to
(
d)(
ii),
to
read
as
follows:

§
51.309
Requirements
related
to
the
Grand
Canyon
Visibility
Transport
Commission.

*
*
*
*
*
(
b)(
6)
Continuous
decline
in
total
mobile
source
emissions
means
that
the
projected
level
of
emissions
from
mobile
sources
of
each
listed
pollutant
in
2008,
2013,
and
2018,
are
less
than
the
projected
level
of
emissions
from
mobile
sources
of
each
listed
pollutant
for
the
previous
period
(
i.
e.,
2008
less
than
2003;
2013
less
than
2008;
and
2018
less
than
2013).
*
*
*
*
*
(
d)(
5)(
i)
Statewide
inventories
of
onroad
and
nonroad
mobile
source
emissions
of
VOC,
NOX,
SO2,
PM2.5,
elemental
carbon,
and
organic
carbon
for
the
years
2003,
2008,
2013,
and
2018.
(
A)
The
inventories
must
demonstrate
a
continuous
decline
in
total
mobile
source
emissions
(
onroad
plus
nonroad;
tailpipe
and
evaporative)
of
VOC,
NOX,
PM2.5,
elemental
carbon,
and
organic
carbon,
evaluated
separately.
If
the
inventories
show
a
continuous
decline
in
total
mobile
source
emissions
of
each
of
these
pollutants
over
the
period
2003
 
2018,
no
further
action
is
required
as
part
of
this
plan
to
address
mobile
source
emissions
of
these
pollutants.
If
the
inventories
do
not
show
a
continuous
decline
in
mobile
source
emissions
of
one
or
more
of
these
pollutants
over
the
period
2003
 
2018,
the
plan
submission
must
provide
for
an
implementation
plan
revision
by
no
later
than
December
31,
2008
containing
any
necessary
long­
term
strategies
to
achieve
a
continuous
decline
in
total
mobile
source
emissions
of
the
pollutant(
s),
to
the
extent
practicable,
considering
economic
and
technological
reasonableness
and
Federal
preemption
of
vehicle
standards
and
fuel
standards
under
title
II
of
the
CAA.
(
B)
The
plan
submission
must
also
provide
for
an
implementation
plan
revision
by
no
later
than
December
31,
2008
containing
any
long­
term
strategies
necessary
to
reduce
emissions
of
SO2
from
nonroad
mobile
sources,
consistent
with
the
goal
of
reasonable
progress.
In
assessing
the
need
for
such
long­
term
strategies,
the
State
may
consider
emissions
reductions
achieved
or
anticipated
from
any
new
Federal
standards
for
sulfur
in
nonroad
diesel
fuel.
(
ii)
[
text
of
(
iv)
retained
same
as
before]

[
FR
Doc.
03
 
16922
Filed
7
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0135;
FRL
 
7313
 
7]

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

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39847
Federal
Register
/
Vol.
68,
No.
128
/
Thursday,
July
3,
2003
/
Rules
and
Regulations
SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
fludioxonil
in
or
on
Brassica,
head
and
stem,
subgroup
5A;
brassica,
leafy
greens,
subgroup
5B;
carrot;
herb,
fresh,
subgroup
19A;
herb,
dried,
subgroup
19A;
longan;
lychee;
pulasan;
rambutan;
spanish
lime;
and
turnip,
greens.
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
This
regulation
also
deletes
brassica,
leafy,
group
at
0.01
parts
per
million
(
ppm),
which
is
replaced
with
brassica,
leafy
greens,
subgroup
5B
at
10
ppm,
and
brassica,
head
and
stem,
subgroup
5A
at
2.0
ppm.
DATES:
This
regulation
is
effective
July
3,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0135,
must
be
received
on
or
before
September
2,
2003.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
an
are
agricultural
producer,
food
manufacturer,
and
pesticide
manufacturer.
Potentially
affected
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
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in.
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
 
0135.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
April
2,
2003
(
68
FR
16046)
(
FRL
 
7299
 
6),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP
2E6448,
2E6462,
2E6486,
and
3E6526)
by
IR­
4,
681
US
Highway
#
1
South,
New
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petitions
prepared
by
Syngenta
Crop
Protection,
Inc.,
the
registrant.
The
petitions
requested
that
40
CFR
180.516
be
amended
by
establishing
tolerances
for
residues
of
the
fungicide
fludioxonil,
(
4­(
2,2­
difluoro­
1,3­
benzodioxol­
4­
yl)­
1H­
pyrrole­
3­
carbonitrile),
in
or
on
the
following
commodities:
Brassica,
head
and
stem,
subgroup
5A
at
1.5
ppm;
brassica,
leafy
greens,
subgroup
5B
at
9.0
ppm;
carrot
at
0.5
ppm;
herb
subgroup
19A
at
33
ppm;
longan,
lychee,
pulasan,
rambutan,
and
spanish
lime
at
2.0
ppm;
and
turnip,
greens
at
9.0
ppm.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
tolerances
for
residues
of
fludioxonil
on
Brassica,
head
and
stem,
subgroup
5A
at
2.0
ppm;
brassica,
leafy
greens,
subgroup
5B
at
10
ppm;
carrot
at
0.75
ppm;
herb,
fresh,
subgroup
19A
at
10
ppm;
herb,
dried,
subgroup
19A
at
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65
ppm;
longan,
lychee,
pulasan,
rambutan,
and
spanish
lime
at
1.0
ppm;
and
turnip,
greens
at
10
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
follow.

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
fludioxonil
are
discussed
in
Unit
III.
A.
of
the
final
rule
on
fludioxonil,
which
published
in
the
Federal
Register
of
December
29,
2000
(
65
FR
82927)
(
FRL
 
6760
 
9),
and
August
2,
2002
(
67
FR
50354)
(
FRL
 
7188
 
7).

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
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
factors
(
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
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
(
MOE
cancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
fludioxonil
used
for
human
risk
assessment
is
Unit
III.
B.
of
the
final
rule
on
fludioxonil,
which
published
in
the
Federal
Register
of
December
29,
2000
(
65
FR
82927)
and
August
2,
2002
(
67
FR
50354).

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.516)
for
the
residues
of
fludioxonil,
in
or
on
a
variety
of
raw
agricultural
commodities.
Fludioxonil
is
registered
for
foliar
application
(
grape,
strawberry,
green
onion,
dry
bulb
onion,
bushberry,
caneberry,
juneberry,
longonberry,
pistachio,
salal,
and
watercress),
postharvest
application
(
stone
fruit),
and
for
seed
treatment
purposes
(
numerous
crops)
with
tolerances
for
residues
of
fludioxonil
ranging
from
0.01­
7.0
ppm
(
40
CFR
180.516(
a)).
A
section
18
registration
is
also
established
for
postharvest
application
to
pomegranate
with
a
tolerance
for
residues
of
fludioxonil
of
5.0
ppm
(
40
CFR
180.516(
b)).
Currently
there
are
no
tolerances
established
for
residues
of
fludioxonil
in/
on
livestock.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
fludioxonil
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
1
 
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996,
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:
The
acute
analysis
assumed
tolerance
level
residues,
100%
crop
treatment
(
CT),
and
DEEM
(
ver.
7.76)
default
processing
factors
for
all
registered/
proposed
commodities
(
tier
1).
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,
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
The
chronic
analysis
assumed
tolerance
level
residues,
100%
CT,
and
DEEM
(
ver.
7.76)
default
processing
factors
for
all
registered/
proposed
commodities
(
tier
1).
iii.
Cancer.
EPA's
Cancer
Peer
Review
Committee
(
CPRC)
classified
fludioxonil
as
a
Group
D
­
not
classifiable
as
to
human
carcinogenicity.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
fludioxonil
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
fludioxonil.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone
model/
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
ground
water.
For
a
screening­
level
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.
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
and
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
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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
screen
for
sorting
out
pesticides
for
which
it
is
unlikely
that
drinking
water
concentrations
would
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
fludioxonil
they
are
further
discussed
in
the
aggregate
risk
sections
E.
There
are
no
ground
or
surface
water
monitoring
data
available
for
fludioxonil.
Tier
I
models,
FIRST
and
SCI­
GROW,
were
used
to
derive
the
surface
water
and
ground
water
EECs,
respectively.
According
to
the
proposed
label
information,
the
maximum
application
rate
for
fludioxonil
is
4
lbs
active
ingredient
(
ai)/
Acre/
year
on
turf
(
maximum
single
application
rate
of
0.675
lbs
ai/
Acre).
Application
to
turf
provided
the
high
exposure
scenario;
therefore,
the
drinking
water
EECs
were
derived
from
the
use
on
turf.
Ground
water.
SCI­
GROW
provides
a
ground
water
screening
exposure
value
for
use
in
determining
the
potential
risk
to
human
health
from
drinking
ground
water
contaminated
with
pesticides.
The
ground
water
modeling
generated
a
ground
water
EEC
of
0.11
parts
per
billion
(
ppb)
for
fludioxonil.
Surface
water.
The
predicted
index
reservoir
concentrations
for
total
residues
using
FIRST
for
the
proposed
use
of
fludioxonil
generated
acute
and
chronic
surface
water
EECs
of
132
ppb
and
49
ppb,
respectively.
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).
Fludioxonil
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
Based
on
the
registered
labels,
fludioxonil
can
be
used
as
a
protectant
fungicide
for
control
of
certain
diseases
of
turfgrass
and
certain
foliar,
stem
and
root
diseases
in
ornamentals
in
residential
and
commercial
landscapes.
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
Short­
and
intermediateterm
dermal
exposures
(
adults
and
toddlers),
and
short­
and
intermediateterm
incidental
ingestion
exposures
(
toddlers).
Fludioxonil
is
registered
for
uses
on
residential
lawns
and
ornamentals;
however,
it
is
restricted
to
professional
applicators
only.
As
such,
no
residential
handler
(
i.
e.,
applicator)
exposures
are
anticipated.
EPA
did
not
select
short­
or
intermediate­
term
dermal
endpoints;
subsequently,
no
residential
postapplication
dermal
assessment
is
included.
Additionally,
due
to
the
low
vapor
pressure
of
fludioxonil,
no
significant
post­
application
inhalation
exposure
is
anticipated.
As
a
result,
there
are
no
significant
post­
application
exposures
anticipated
from
treated
landscape
ornamentals.
Therefore,
the
residential
component
of
this
assessment
only
includes
a
postapplication
assessment
for
toddler
incidental
ingestion
exposures
related
to
residential
lawn
applications.
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
fludioxonil
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
fludioxonil
and
any
other
substances
and
fludioxonil
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
fludioxonil
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
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
The
developmental
and
reproductive
toxicity
data
did
not
indicate
increased
quantitative
or
qualitative
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
fludioxonil
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
reduced
to
1X
because:
 
The
toxicology
data
base
is
complete.
 
The
developmental
and
reproductive
toxicity
data
did
not
indicate
increased
quantitative
or
qualitative
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure.
 
A
developmental
neurotoxicity
study
is
not
required
because
there
was
no
evidence
of
neurotoxicity
in
the
current
toxicity
data
base.
 
The
exposure
assessment
approach
will
not
underestimate
the
potential
dietary
(
food
and
water)
and
non­
dietary
exposures
for
infants
and
children
resulting
from
the
use
of
fludioxonil.

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
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Rules
and
Regulations
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
milligram/
kilogram
(
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,
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
fludioxonil
will
occupy
1%
of
the
aPAD
for
females
13­
49
years
old.
Fludioxonil
is
not
expected
to
pose
an
acute
dietary
risk
for
the
general
population
(
including
children
and
infants).
In
addition,
there
is
potential
for
acute
dietary
exposure
to
fludioxonil
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
for
females
13
 
49
years
old,
as
shown
in
Table
1
of
this
unit:

TABLE
1.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
FLUDIOXONIL
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

Females
(
13­
49
years
old)
1.0
1
132
0.11
30,000
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
fludioxonil
from
food
will
utilize
11%
of
the
cPAD
for
the
U.
S.
population,
30%
of
the
cPAD
for
all
infants
(<
1
year
old)
and
38%
of
the
cPAD
for
children
1
 
2
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
fludioxonil
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
fludioxonil
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
Table
2
of
this
unit:

TABLE
2.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
FLUDIOXONIL
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.3
11
49
0.11
940
All
infants
(<
1
year
old)
0.3
30
49
0.11
210
Children
(
1­
2
years
old)
0.3
38
49
0.11
190
Females
(
13­
49
years
old)
0.3
8
49
0.11
830
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).
Fludioxonil
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
fludioxonil.
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
460
for
all
infants
<
1
year
old;
410
for
children
1
 
2
years
old;
490
for
children
3
 
5
years
old.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
fludioxonil
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
Table
3
of
this
unit:

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Rules
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Regulations
TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
FLUDIOXONIL
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

All
infants
(<
1
year
old)
460
100
49
0.11
780
Children
(
1­
2
years
old)
410
100
49
0.11
760
Children
(
3­
5
years
old)
490
100
49
0.11
800
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).
Fludioxonil
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
fludioxonil.
Using
the
exposure
assumptions
described
in
this
unit
for
intermediateterm
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
200
for
all
infants
<
1
year
old;
180
for
children
1
 
2
years
old;
and
220
for
children
3
 
5
years
old.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
intermediate­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
fludioxonil
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
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
Table
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
INTERMEDIATE­
TERM
EXPOSURE
TO
FLUDIOXONIL
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

All
infants
(<
1
year
old)
200
100
49
0.11
130
Children
(
1­
2
years
old)
180
100
49
0.11
140
Children
(
3­
5
years
old)
220
100
49
0.11
180
5.
Aggregate
cancer
risk
for
U.
S.
population.
EPA's
Cancer
Peer
Review
Committee
(
CPRC)
classified
fludioxonil
as
a
Group
D
­
not
classifiable
as
to
human
carcinogenicity.
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
fludioxonil
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
methods
used
in
the
field
trial
studies
were
similar
to
a
method
validated
by
the
Analytical
Chemistry
Branch.
Since
adequate
method
validation
and
concurrent
recoveries
were
attained
in
the
field
trial
studies,
EPA
concludes
that
the
ACB
validated
method
is
appropriate
for
enforcement
of
the
tolerances
associated
with
this
petition.
No
further
validation
is
necessary.
Adequate
enforcement
methodology
(
high
pressure
liquid
chromatography
method
AG
 
597B)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
email
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
Canada,
Codex,
and
Mexico
do
not
have
maximum
residue
limits
(
MRLs)
for
residues
of
fludioxonil
in/
on
the
subject
crops.
Therefore,
harmonization
is
not
an
issue.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
residues
of
fludioxonil,
(
4­(
2,2­
difluoro­
1,3­
benzodioxol­
4­
yl)­
1H­
pyrrole­
3­
carbonitrile)
in
or
on
brassica,
head
and
stem,
subgroup
5A
at
2.0
ppm;
brassica,
leafy
greens,
subgroup
5B
at
10
ppm;
carrot
at
0.75
ppm;
herb,
fresh,
subgroup
19A
at
10
ppm;
herb,
dried,
subgroup
19A
at
65
ppm;
longan,
lychee,
pulasan,
rambutan,
and
spanish
lime
at
1.0
ppm;
and
turnip,
greens
at
10
ppm.
VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

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2003
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Rules
and
Regulations
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
 
0135
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
2,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0135,
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
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Federal
Register
/
Vol.
68,
No.
128
/
Thursday,
July
3,
2003
/
Rules
and
Regulations
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
25,
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.


2.
Section
180.516
is
amended
by
removing
the
entry
for
``
Vegetable,
brassica,
leafy,
group''
and
by
alphabetically
adding
the
following
commodities
to
the
table
in
paragraph
(
a)
to
read
as
follows:

§
180.516
Fludioxonil;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
Brassica,
head
and
stem,
subgroup
5A
............................................................................
2.0
Brassica,
leafy
greens,
subgroup
5B
................................................................................
10
*
*
*
*
*
Carrot
.................................................................................................................................
0.75
*
*
*
*
*
Herb,
dried,
subgroup
19A
................................................................................................
65
Herb,
fresh,
subgroup
19A
................................................................................................
10
*
*
*
*
*
Longan
...............................................................................................................................
1.0
Lychee
...............................................................................................................................
1.0
*
*
*
*
*
Pulasan
..............................................................................................................................
1.0
*
*
*
*
*
Rambutan
..........................................................................................................................
1.0
*
*
*
*
*
Spanish
lime
......................................................................................................................
1.0
*
*
*
*
*
Turnip,
greens
....................................................................................................................
10
*
*
*
*
*

*
*
*
*
*

[
FR
Doc.
03
 
16931
Filed
7
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
THE
INTERIOR
Office
of
the
Secretary
43
CFR
Part
10
RIN
1024
 
AC84
Native
American
Graves
Protection
and
Repatriation
Act
Regulations
 
Civil
Penalties;
Correction
AGENCY:
Department
of
the
Interior.
ACTION:
Final
rules
correction.
SUMMARY:
This
document
corrects
the
final
rule
that
was
published
on
Thursday,
April
3,
2003.
This
final
rule
outlines
procedures
for
assessing
civil
penalties
on
museums
that
fail
to
comply
with
applicable
provisions
of
the
Native
American
Graves
Protection
and
Repatriation
Act
of
1990
(``
the
Act''
or
``
NAGPRA'').

EFFECTIVE
DATE:
May
5,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Mr.
John
Robbins,
Assistant
Director,
Cultural
Resources,
National
Park
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