Document ID: EPA-HQ-OPP-2003-0244-0001
Agency: epa
Document Type: Rule
Title: Trifloxystrobin; Pesticide Tolerance
Posted Date: 2003-09-10T04:00Z

53297
Federal
Register
/
Vol.
68,
No.
175
/
Wednesday,
September
10,
2003
/
Rules
and
Regulations
statements,
Indians,
Intergovernmental
relations,
Forest
and
forest
products,
National
forests,
Natural
resources,
Reporting
and
recordkeeping
requirements,
Science
and
technology.


Therefore,
for
the
reasons
set
forth
in
the
preamble,
Part
219
of
Title
36
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
219
 
PLANNING
Subpart
A
 
National
Forest
System
Land
and
Resource
Management
Planning

1.
The
authority
citation
for
subpart
A
continues
to
read
as
follows:

Authority:
5
U.
S.
C.
301;
and
Secs.
6
and
15,
90
Stat.
2949,
2952,
2958
(
16
U.
S.
C.
1604,
1613).


2.
Revise
paragraph
(
d)
of
§
219.35
to
read
as
follows:

§
219.35
Transition.

*
*
*
*
*
(
d)
The
date
by
which
site­
specific
decisions
made
by
the
responsible
official
must
be
in
conformance
with
the
provisions
of
this
subpart
is
extended
from
November
9,
2003,
until
the
Department
promulgates
the
final
planning
regulations
published
as
proposed
on
December
6,
2002
(
67
FR
72770).
*
*
*
*
*

Dated:
September
3,
2003.
David
P.
Tenny,
Deputy
Under
Secretary,
Natural
Resources
and
Environment.
[
FR
Doc.
03
 
22977
Filed
9
 
9
 
03;
8:
45
am]

BILLING
CODE
3410
 
11
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0244;
FRL
 
7322
 
7]

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

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
trifloxystrobin
in
or
on
leaf
petioles
subgroup
4B;
and
vegetable,
root,
except
sugar
beet,
subgroup
1B,
except
radish.
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).
DATES:
This
regulation
is
effective
September
10,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0244,
must
be
received
on
or
before
November
10,
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.
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
 
0244.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
March
5,
2003
(
68
FR
10469)
(
FRL
 
7294
 
5),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
3E6522)
by
IR­
4,
681
U.
S.
Highway
#
1
South,
New
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petition
prepared
by
Bayer
CropScience,
the
registrant.
There
were
no
comments
received
on
this
petition.
The
petition
requested
that
40
CFR
180.555
be
amended
by
establishing
tolerances
for
combined
residues
of
the
fungicide,
trifloxystrobin,
(
benzeneacetic
acid,
(
E,
E)­
a­
(
methoxyimino)­
2­[[[[
1­[
3­
(
trifluoromethyl)
phenyl]
ethylidene]
amino]
oxy]
methyl]­,
methyl
ester)
and
the
free
form
of
its
acid
metabolite
CGA­
321113((
E,
E)­
methoxyimino­[
2­[
1­(
3­
trifluoromethylphenyl)
ethylideneaminooxymethyl]
phenyl]
acetic
acid),
in
or
on
the
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/
Vol.
68,
No.
175
/
Wednesday,
September
10,
2003
/
Rules
and
Regulations
following
commodities:
Leaf
petioles
subgroup
4B
at
2.0
parts
per
million
(
ppm),
and
vegetable,
root,
except
sugar
beet,
subgroup
1B,
except
radish
at
0.10
ppm.
The
petition
was
subsequently
amended
to
propose
the
tolerance
for
the
leaf
petioles
subgroup
4B
at
3.5
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
combined
residues
of
trifloxystrobin
and
the
free
form
of
its
acid
metabolite
CGA­
321113
on
leaf
petioles
subgroup
4B
at
3.5
ppm,
and
vegetable,
root,
except
sugar
beet,
subgroup
1B,
except
radish
at
0.10
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
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
trifloxystrobin
are
discussed
in
Unit
III.
A.
of
the
final
rule
on
trifloxystrobin,
which
was
published
in
the
Federal
Register
of
May
22,
2002
(
67
FR
35915)
(
FRL
 
7178
 
6).

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences.
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
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
trifloxystrobin
used
for
human
risk
assessment
is
shown
in
Table
1
of
this
unit:

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Federal
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/
Vol.
68,
No.
175
/
Wednesday,
September
10,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
TRIFLOXYSTROBIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
*
Special
FQPA
SF
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
females
13
 
49
only.
NOAEL
=
250
mg/
kg/
day
UF
=
100
Acute
RfD
=
2.5
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
aRfD
÷
FQPA
SF
=
2.5
mg/
kg/
day
Developmental
toxicity­
Rat
LOAEL
=
500
mg/
kg/
day,
based
upon
increased
fetal
skeletal
anomalies
Acute
dietary
general
population
including
infants
and
children.
There
were
no
appropriate
toxicological
effects
attributable
to
a
single
exposure
(
dose)
observed
in
oral
toxicity
studies
including
maternal
effects
in
developmental
studies
in
rats
and
rabbits.
Therefore,
a
dose
and
endpoint
were
not
identified
for
this
risk
assessment
Chronic
dietary
all
populations.
Parental
NOAEL
=
3.8
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.038
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
cRfD
÷
FQPA
SF
=
0.038
mg/
kg/
day
2
 
generation
reproduction
study­
Rat
LOAEL
=
55.3
mg/
kg/
day,
based
upon
decreases
in
body
weight,
body
weight
gains,
reduced
food
consumption
and
histopathological
lesions
in
the
liver,
kidneys
and
spleen
Short­
Term
Oral
(
1
 
30
days).
Intermediate­
Term
Oral
(
1
 
6
months)
Offspring
NOAEL
=
3.8
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
2
 
Generation
reproduction
study­
Rat
LOAEL
=
55.3
mg/
kg/
day,
based
upon
reduced
pup
body
weights
during
lactation
Short­
Term
Dermal
(
1
 
30
days).
Intermediate­
term
dermal
(
1
 
6
months)
Dermal
study
NOAEL
=
100
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
28
 
Day
dermal
toxicity
study­
Rat
LOAEL
=
1,000
mg/
kg/
day,
based
upon
increases
in
mean
absolute
and
relative
liver
and
kidney
weights
Long­
term
dermal
(>
6
months).
Oral
study
NOAEL
=
3.8
mg/
kg/
day
(
dermal
absorption
rate
=
33%)
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
2
 
Generation
reproduction
study­
Rat
LOAEL
=
55.3
mg/
kg/
day,
based
upon
reduced
pup
body
weights
during
lactation
Short­
term
inhalation
(
1
 
30
days).
Intermediate­
Term
Inhalation
(
1
 
6
months)
Long­
Term
Inhalation
(>
6
months)
Oral
study
NOAEL
=
3.8
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
2
 
Generation
reproduction
study­
Rat
LOAEL
=
55.3
mg/
kg/
day,
based
upon
reduced
pup
body
weights
during
lactation
Cancer
(
oral,
dermal
inhalation).
Trifloxystrobin
is
classified
as
``
Not
Likely
Human
Carcinogen''
based
on
the
lack
of
evidence
of
carcinogenicity
in
mouse
and
rat
cancer
studies
C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.555)
for
the
residues
of
trifloxystrobin,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
trifloxystrobin
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.
In
conducting
this
acute
dietary
risk
assessment
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Data
base
(
DEEM­
FCID
 
)
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessment:
The
acute
dietary
exposure
analysis
for
trifloxystrobin
is
a
Tier
I
assessment
because
no
additional
data
were
used
to
refine
the
analysis.
One
hundred
percent
of
proposed
and
registered
crops
are
assumed
treated
with
trifloxystrobin
(``
100%
CT''),
and
tolerance­
level
residues
were
used
in
the
analysis.
ii.
Chronic
exposure.
In
conducting
this
acute
dietary
risk
assessment
EPA
used
the
DEEM
 
software
with
the
DEEM­
FCID
 
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessment:
The
chronic
dietary
exposure
analysis
for
trifloxystrobin
is
a
Tier
I
assessment
because
no
additional
data
were
used
to
refine
the
analysis.
One
hundred
percent
of
proposed
and
registered
crops
are
assumed
treated
with
trifloxystrobin,
and
tolerance­
level
residues
were
used
in
the
analysis.
iii.
Cancer.
The
Agency
determined
that
trifloxystrobin
should
be
classified
as
a
``
Not
Likely
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
trifloxystrobin
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
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/
Rules
and
Regulations
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
trifloxystrobin.
The
Agency
uses
the
FQPA
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
I
model)
before
using
PRZM/
EXAMS
(
a
Tier
II
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
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
LOC.
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
trifloxystrobin
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E.
Trifloxystrobin
is
immobile,
and
degrades
rapidly
in
soil
and
aquatic
environments
to
the
primary
isomer,
CGA­
321113.
EECs
were
calculated
for
total
trifloxystrobin
residues
(
parent
trifloxystrobin
plus
metabolites)
using
the
FIRST
model
for
surface
water
and
the
SCI­
GROW
model
for
ground
water.
EPA's
interim
method
for
drinking
water
estimates
for
pesticides
used
in
rice
paddies
was
also
used
to
generate
surface
water
EECs.
Surface
water
concentrations
for
total
trifloxystrobin
residues
are
92
parts
per
billion
(
ppb)
for
the
peak
value
(
acute)
and
50
ppb
for
the
chronic
value
using
the
FIRST
model
for
terrestrial
uses
(
turfgrass).
To
estimate
surface
water
concentrations
for
use
on
rice,
an
interim
rice
paddy
model
was
used.
For
surface
water
concentrations
from
treated
rice,
the
acute
estimate
for
the
parent
is
48
ppb,
and
the
chronic
estimate
for
the
total
parent
plus
degradate
is
140
ppb.
The
rice
estimate
is
considered
to
be
an
overestimate
of
the
true
value
found
in
the
environment
due
to
the
assumptions
used
in
the
drinking
water
model
for
rice.
Further,
EPA
considers
the
turfgrass
estimate
to
be
a
more
realistic
estimate
of
drinking
water
residues.
The
ground
water
screening
concentration
used
for
both
acute
and
chronic
assessments
is
3.4
ppb.
These
values
represent
upperbound
estimates
of
the
concentrations
of
total
residues
of
trifloxystrobin
that
might
be
found
in
surface
water
and
ground
water
from
uses
on
turfgrass
at
the
maximum
application
rate.
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).
Trifloxystrobin
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
Turfgrass
and
ornamental
(
CompassTM).
Postapplication
exposures
from
various
activities
following
lawn
treatment
are
considered
to
be
the
most
common
and
significant
in
residential
settings.
There
is
potential
for
dermal
exposure
to
adults
and
children
and
oral
exposure
to
children
during
postapplication
activities.
Four
postapplication
exposure
scenarios
resulting
from
lawn
treatment
were
assessed,
as
follows:
(
1)
Dermal
exposure
from
pesticide
residues
on
lawns,
(
2)
incidental
non­
dietary
ingestion
of
pesticide
residues
on
lawns
from
hand­
to­
mouth
transfer,
(
3)
incidental
non­
dietary
ingestion
of
residues
from
object­
to
mouth
activities
(
pesticide­
treated
turfgrass),
and
(
4)
incidental
non­
dietary
ingestion
of
soil
from
pesticide­
treated
residential
areas.
Exposure
via
incidental
non­
dietary
ingestion
involving
plant
material
may
occur
but
is
considered
negligible.
Since
the
application
of
trifloxystrobin
on
turf
grass
and
ornamental
is
limited
to
certified
pest
control
operators,
an
assessment
of
dermal
or
inhalation
exposure
for
residential
handlers
was
not
performed.
The
MOE
for
adult
dermal
risk
from
postapplication
exposure
is
1,300
and
800
for
children.
Children's
risk
from
oral
exposures
range
from
1,600
to
220,000.
When
incidental
oral
exposure
from
all
possible
residential
sources
are
combined
(
ingestion
of
residues
on
turfgrass
from
hand­
to­
mouth
activities,
mouthing
turfgrass
and
eating
soil),
the
result
is
an
MOE
of
1,100.
Therefore,
postapplication
exposure
and
risk
estimates
for
adults
and
children
are
considered
to
be
below
EPA's
LOC.
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
trifloxystrobin
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
trifloxystrobin
and
any
other
substances
and
trifloxystrobin
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
trifloxystrobin
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
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10,
2003
/
Rules
and
Regulations
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.
There
is
no
indication
of
increased
susceptibility
of
rat
or
rabbits
to
trifloxystrobin.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
trifloxystrobin
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:
i.
There
is
no
indication
of
increased
susceptibility
of
rat
or
rabbits
to
trifloxystrobin.
In
the
developmental
and
reproduction
toxicity
studies,
effects
in
the
fetuses/
offspring
were
observed
only
at
or
above
treatment
levels
which
resulted
in
evidence
of
parental
toxicity.
ii.
The
Agency
determined
that
a
developmental
neurotoxicity
study
in
rats
is
not
required.
iii.
Although
an
acute
neurotoxicity
study
is
required
(
the
submitted
study
was
unacceptable),
the
lack
of
an
acute
neurotoxicity
study
does
not
impact
EPA's
ability
to
make
an
FQPA
SF
decision.
iv.
The
acute
and
chronic
dietary
food
exposure
assessments
utilize
existing
and
proposed
tolerance
level
residues
and
100%
crop
treated
information
for
all
commodities.
By
using
these
screening­
level
assessments,
actual
exposures/
risks
will
not
be
underestimated.
v.
The
exposure
assessments
will
not
underestimate
the
potential
dietary
(
food
and
drinking
water)
or
non­
dietary
exposures
for
infants
and
children
from
the
use
of
trifloxystrobin.
vi.
The
dietary
drinking
water
assessment
utilizes
water
concentration
values
generated
by
model
and
associated
modeling
parameters
which
are
designed
to
provide
conservative,
health
protective,
high­
end
estimates
of
water
concentrations
which
are
not
likely
to
be
exceeded.
vii.
The
residential
postapplication
assessment
is
based
upon
the
residential
Standard
Operating
Procedures
(
SOPs).
The
assessment
is
based
upon
surrogate
study
data.
These
data
are
reliable
and
are
not
expected
to
underestimate
risk
to
adults
or
children.
The
residential
SOPs
are
based
upon
reasonable
``
worstcase
assumptions
and
are
not
expected
to
underestimate
risk.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
(
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
trifloxystrobin
will
occupy
<
1%
of
the
aPAD
for
females
13
 
49
years
old.
An
acute
dietary
endpoint
for
the
general
population
including
infants
and
children
was
not
identified.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
trifloxystrobin
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
2
of
this
unit:

TABLE
2.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
TRIFLOXYSTROBIN
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

Females
(
13
 
49
years
old)
......................................................................
2.5
<
1
92
turf
48
rice
3.4
75,000
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
trifloxystrobin
from
food
will
utilize
14%
of
the
cPAD
for
the
U.
S.
population,
54%
of
the
cPAD
for
children
1
 
2
years
old,
10%
of
the
cPAD
for
females
13
 
49
years
old,
and
10%
of
the
cPAD
for
adults
50+
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
trifloxystrobin
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
trifloxystrobin
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
3
of
this
unit:

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Rules
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TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
TRIFLOXYSTROBIN
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
........................................................................................
0.038
14
140
rice
50
turf
3.4
1,100
Children
(
1
 
2
years
old)
..........................................................................
0.038
54
140
rice
50
turf
3.4
170
Females
(
13
 
49
years
old)
......................................................................
0.038
10
140
rice
50
turf
3.4
1,000
Adults
(
50+
years
old)
.............................................................................
0.038
10
140
rice
50
turf
3.4
1,200
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).
Trifloxystrobin
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
trifloxystrobin.
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
690
for
the
U.
S.
Population;
154
for
children
1
 
2
years
old;
970
for
females
13
 
49
years
old;
and
950
for
adults
50+
years
old.
These
aggregate
MOEs
do
not
exceed
the
Agency's
LOC
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
trifloxystrobin
in
ground
water
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
LOC,
as
shown
in
Table
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
TRIFLOXYSTROBIN
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
........................................................................................
690
100
140
rice
50
turf
3.4
1,100
Children
1
 
2
years
old
.............................................................................
154
100
140
rice
50
turf
3.4
130
Females
13
 
50
years
old
........................................................................
970
100
140
rice
50
turf
3.4
1,000
Adults
50+
years
old
................................................................................
950
100
140
rice
50
turf
3.4
1,200
4.
Intermediate­
term
risk.
The
intermediate­
term
aggregate
risk
assessment
estimates
risks
likely
to
result
from
1
to
6
months
of
exposure
(
30
to
180
days)
to
trifloxystrobin
residues
from
food,
drinking
water,
and
residential
pesticide
uses.
Intermediateterm
exposure
to
trifloxystrobin
is
not
expected
to
occur
based
on
the
chemical's
short
soil
half­
life
(
about
2
days).
Therefore,
no
intermediate­
term
aggregate
risk
is
expected.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Trifloxystrobin
is
not
expected
to
pose
a
cancer
risk
to
humans.
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
trifloxystrobin
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
(
gas
chromatography
method
using
nitrogen/
phosphorus
detector)
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;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
Codex,
Canadian,
or
Mexican
maximum
residue
limits
established
for
trifloxystrobin.
Harmonization
is
thus
not
an
issue
at
this
time.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
combined
residues
of
trifloxystrobin,
(
benzeneacetic
acid,
(
E,
E)­
a­(
methoxyimino)­
2­[[[[
1­[
3­
(
trifluoromethyl)
phenyl]
ethylidene]
amino]
oxy]
methyl]­,
methyl
ester)
and
the
free
form
of
its
acid
metabolite
CGA­
321113((
E,
E)­
methoxyimino­[
2­[
1­(
3­
trifluoromethyl
phenyl)
ethylideneaminooxymethyl]
phenyl]
acetic
acid)
in
or
on
leaf
petioles
subgroup
4B
at
3.5
ppm,
and
vegetable,
root,
except
sugar
beet,
subgroup
1B,
except
radish
at
0.10
ppm.

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Wednesday,
September
10,
2003
/
Rules
and
Regulations
VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0244
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
10,
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
 
0244,
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
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Federal
Register
/
Vol.
68,
No.
175
/
Wednesday,
September
10,
2003
/
Rules
and
Regulations
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
August
29,
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
180.555
is
amended
by
adding
commodities
to
the
table
in
paragraph
(
a)
to
read
as
follows:

§
180.555
Trifloxystrobin;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Leaf
petioles
subgroup
4B
................................
3.5
*
*
*
*
*
Vegetable,
root,
except
sugar
beet,
subgroup
1B,
except
radish
........
0.10
*
*
*
*
*

*
*
*
*
*
[
FR
Doc.
03
 
23054
Filed
9
 
9
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
73
[
DA
03
 
2762,
MB
Docket
No.
02
 
83,
RM
 
10404]

Digital
Television
Broadcast
Service;
Sault
Saint
Marie,
MI
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.

SUMMARY:
The
Commission,
at
the
request
of
Scanlan
Television,
Inc.,
substitutes
DTV
channel
9c
for
DTV
channel
56
at
Sault
Saint
Marie,
Michigan.
See
67
FR
20941,
April
29,
2002.
DTV
channel
9c
can
be
allotted
to
Sault
Saint
Marie
in
compliance
with
the
principle
community
coverage
requirements
of
§
73.625(
a)
at
reference
coordinates
46
 
03
 
08
N.
and
84
 
06
 
38
W.
with
a
power
of
24,
HAAT
of
291
meters
and
with
a
DTV
service
population
of
84
thousand.
Since
the
community
of
Sault
Saint
Marie
is
located
within
400
kilometers
of
the
U.
S.­
Canadian
border,
concurrence
from
the
Canadian
government
has
been
obtained
for
this
allotment.
With
this
action,
this
proceeding
is
terminated.
DATES:
Effective
October
20,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Pam
Blumenthal,
Media
Bureau,
(
202)
418
 
1600.

SUPPLEMENTARY
INFORMATION:
This
is
a
synopsis
of
the
Commission's
Report
and
Order,
MB
Docket
No.
02
 
83,
adopted
August
28,
2003,
and
released
September
4,
2003.
The
full
text
of
this
document
is
available
for
public
inspection
and
copying
during
regular
business
hours
in
the
FCC
Reference
Information
Center,
Portals
II,
445
12th
Street,
SW.,
Room
CY
 
A257,
Washington,
DC.
This
document
may
also
be
purchased
from
the
Commission's
duplicating
contractor,
Qualex
International,
Portals
II,
445
12th
Street,
SW.,
CY
 
B402,
Washington,
DC
20554,
telephone
202
 
863
 
2893,
facsimile
202
 
863
 
2898,
or
via
e­
mail
qualexint@
aol.
com.

List
of
Subjects
in
47
CFR
Part
73
Digital
television
broadcasting,
Television.


Part
73
of
Title
47
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
73
 
[
AMENDED]


1.
The
authority
citation
for
Part
73
continues
to
read
as
follows:

Authority:
47
U.
S.
C.
154,
303,
334
and
336.

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