Document ID: EPA-HQ-OPP-2003-0196-0001
Agency: epa
Document Type: Notice
Title: Azoxystrobin; Pesticide Tolerance
Posted Date: 2003-06-18T04:00Z

36480
Federal
Register
/
Vol.
68,
No.
117
/
Wednesday,
June
18,
2003
/
Rules
and
Regulations
IX.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
temporary
exemption
from
the
tolerance
requirement
for
Bacillus
pumilus
strain
QST2808
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
exemption
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.

X.
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
3,
2003.
James
Jones,
Director,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.1226
is
added
to
subpart
D
to
read
as
follows:

§
180.1226
Bacillus
pumilus
strain
QST2808;
temporary
exemption
from
the
requirement
of
a
tolerance.
A
temporary
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
the
microbial
pesticide
Bacillus
pumilus
strain
QST2808
when
used
in
or
on
all
agricultural
commodities
when
applied/
used
in
accordance
with
label
directions.

[
FR
Doc.
03
 
15129
Filed
6
 
17
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0196;
FRL
 
7311
 
2]

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

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
azoxystrobin,
methyl
(
E)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­ ­
(
methoxymethylene)­
benzeneacetate,
and
its
Z
isomer,
methyl
(
Z)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­
 (
methoxymethylene)­
benzeneacetate,
in
or
on
artichoke,
globe;
asparagus;
brassica,
head
and
stem,
subgroup
5A;
herb
subgroup
19A,
(
dried)
except
chive;
and
herb
subgroup
19A,
(
fresh)
except
chive.
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).

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36481
Federal
Register
/
Vol.
68,
No.
117
/
Wednesday,
June
18,
2003
/
Rules
and
Regulations
DATES:
This
regulation
is
effective
June
18,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
identification
(
ID)
number
OPP
 
2003
 
0196,
must
be
received
on
or
before
August
18,
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
are
an
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
ID
number
OPP
 
2003
 
0196.
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
26,
2003
(
68
FR
14622)
(
FRL
 
7299
 
3),
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
2E6375,
2E6488,
2E6489,
and
2E6495)
by
IR­
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petitions
prepared
by
Syngenta,
the
registrant.
The
petitions
requested
that
40
CFR
180.507
be
amended
by
establishing
tolerances
for
combined
residues
of
the
fungicide
azoxystrobin,
methyl
(
E)­
2­[[
6­
(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­
 ­(
methoxymethylene)
benzeneacetate
and
its
Z
isomer
methyl
(
Z)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­ ­
(
methoxymethylene)
benzeneacetate,
in
or
on
artichoke,
globe
at
4.0
parts
per
million
(
ppm);
asparagus
at
0.02
ppm;
brassica,
head
and
stem,
subgroup
5A
at
3.0
ppm;
herb
subgroup
19A,
dried,
except
chive
at
260
ppm;
and
herb
subgroup
19A,
fresh,
except
chive
at
50
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
azoxystrobin
on
artichoke,
globe
at
4.0
ppm;
asparagus
at
0.04
ppm;
brassica,
head
and
stem,
subgroup
5A
at
3.0
ppm;
herb
subgroup
19A,
dried,
except
chive
at
260
ppm;
and
herb
subgroup
19A,
fresh,
except
chive
at
50
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
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infants
and
children.
The
nature
of
the
toxic
effects
caused
by
azoxystrobin
are
discussed
in
Unit
III.
A
of
the
Final
Rule
on
Azoxystrobin
Pesticide
Tolerance
published
in
the
Federal
Register
on
September
20,
2002
(
67
FR
59169)(
FRL
 
7198
 
9).

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
factor
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
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
azoxystrobin
used
for
human
risk
assessment
is
discussed
in
Unit
III.
B.
of
the
Final
Rule
on
Azoxystrobin
Pesticide
Tolerance
published
in
the
Federal
Register
on
September
20,
2002
(
67
FR
59169)(
FRL
 
7198
 
9).

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.507)
for
the
combined
residues
of
azoxystrobin,
in
or
on
a
variety
of
raw
agricultural
commodities.
Tolerances
have
been
established
for
residues
of
azoxystrobin
in
or
on
a
variety
of
raw
agricultural
commodities
at
levels
ranging
from
0.01
ppm
(
pecans)
to
55
ppm
(
soybean
hay),
and
on
meat,
fat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
at
levels
ranging
from
0.01
to
0.07
ppm,
and
on
milk
at
0.006
ppm.
A
timelimited
tolerance
(
to
expire
on
12/
31/
2003)
is
currently
established
at
30
ppm
for
the
head
and
stem
Brassica
vegetables,
subgroup
5A.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
azoxystrobin
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
In
conducting
this
acute
risk
assessment,
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCIDTM)
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
assumption
was
made
for
the
acute
exposure
assessment:
A
Tier
1
acute
dietary
exposure
analysis
was
performed
for
azoxystrobin.
ii.
Chronic
exposure.
In
conducting
this
chronic
risk
assessment,
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCIDTM)
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
chronic
exposure
assessments:
The
chronic
dietary
exposure
analysis
was
performed
for
the
general
U.
S.
Population
and
all
population
subgroups
using
tolerance
level
residues
(
livestock)
and
total
residues
of
concern
(
plants;
parent
and
metabolites)
and
100%
crop
treated
data
for
the
proposed
commodities
and
all
registered
uses.
iii.
Cancer.
EPA's
Cancer
Assessment
Review
Committee
(
CARC)
evaluated
the
carcinogenic
potential
of
azoxystrobin
and
classified
azoxystrobin
as
``
not
likely
to
be
a
human
carcinogen''
based
on
the
revised
Cancer
Guidelines.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
azoxystrobin
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
azoxystrobin.
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
groundwater
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
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
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.

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18,
2003
/
Rules
and
Regulations
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
azoxystrobin
they
are
further
discussed
in
the
aggregate
risk
section
in
Unit
III.
E.
Although
moderately
persistent
in
soils
and
stable
to
hydrolysis,
the
likelihood
of
azoxystrobin
moving
into
ground
and
surface
water
is
low
due
to
high
soil/
water
partitioning
coefficients
and
low
single
application
rates.
However,
with
multiple
applications
and
repeated
usage,
azoxystrobin
and
especially
its
degradate
(``
compound
2'',
(
E)­
2­
2­[
6­(
2­
cyanophenoxy)
pyrimidin­
4­
yloxy]­
3­
methoxyacrylic
acid)
may
eventually
build
up
in
environmental
compartments
and
move
into
drinking
water
resources.
Based
on
the
Tier
I
modeling
results
using
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
model,
azoxystrobin
EECs
in
surface
water
are
not
likely
to
exceed
170
parts
per
billion
(
ppb)
for
the
acute
(
peak)
concentration
or
33
ppb
for
the
chronic
(
365
 
day)
concentration.
These
values
represent
upper­
bound
estimates
of
the
concentrations
that
might
be
found
in
surface
water
which
result
from
the
use
of
azoxystrobin
on
turf.
The
SCI­
GROW
screening
model
developed
in
the
Agency
estimates
potential
ground
water
concentrations
under
hydrologically
vulnerable
conditions.
Based
on
the
highest
use
rate
(
turf
use,
nine
applications
per
year,
10
 
day
interval,
and
0.55
lb
ai/
A/
application),
the
upper­
bound
concentration
of
azoxystrobin
was
estimated
at
3.1
ppb.
This
value
was
used
for
both
acute
and
chronic
risk
assessments.
This
value
represents
upper­
bound
estimates
of
the
concentrations
that
might
be
found
in
ground
water
which
result
from
the
use
of
azoxystrobin
on
turf.
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).
Azoxystrobin
is
currently
registered
for
use
on
residential
non­
dietary
sites
(
turf
and
ornamentals).
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
There
is
a
potential
for
short­
term
dermal
and
inhalation
exposures
to
homeowners
who
apply
products
containing
azoxystrobin;
however,
EPA
did
not
identify
dermal
endpoints
for
azoxystrobin.
Because
no
dermal
endpoints
could
be
indentified,
EPA
expects
no
risk
from
dermal
exposure
to
azoxystrobin.
There
is
also
potential
for
non­
dietary,
oral
exposure
following
lawn
treatment.
Short­
and
intermediate­
term
non­
dietary,
oral
exposure
assessments
were
included
for
toddlers,
since
EPA
selected
toxicology
endpoints
for
these
exposures
and
there
is
a
potential
for
hand­
to­
mouth
and
object­
to
mouth
transfer
of
residues
from
treated
turfgrass
and
incidential
ingestion
of
soil
from
treated
turfgrass.
Postapplication
exposures
from
various
activities
following
lawn
treatment
are
considered
to
be
the
most
common
and
significant
in
residential
settings.
The
exposure
via
incidental
ingestion
of
other
plant
material
may
occur
but
is
considered
negligible.
The
residential
exposure
and
risk
assessment
was
conducted
using
the
application
for
turf
because
it
is
the
highest
single
use
rate.
Azoxystrobin
may
be
applied
to
turf
at
rates
of
up
to
0.9516
active
ingredient
(
a.
i.)
per
acre
five
times
per
year
(
i.
e.,
not
to
exceed
5
lb/
ai/
acre/
year).
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
azoxystrobin
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
azoxystrobin
and
any
other
substances
and
azoxystrobin
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
azoxystrobin
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
Web
site
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.
Azoxystrobin
studies
have
indicated
no
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
azoxystrobin.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
azoxystrobin
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10
 
fold
safety
factor
for
increased
susceptibility
of
infants
and
children
be
removed
(
i.
e.,
reduced
to
1X).
The
FQPA
factor
is
removed
because:
 
The
toxicology
data
base
is
complete
 
The
developmental
and
reproductive
toxicity
data
did
not
indicate
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
 
Unrefined
chronic
dietary
exposure
estimates
(
assuming
all
commodities
contain
tolerance
level
residues)
will
overestimate
dietary
exposure
 
Modeling
data
are
used
for
ground
and
surface
source
drinking
water
exposure
assessments
resulting
in
estimates
considered
to
be
upper­
bound
concentrations
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
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Regulations
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
groundwater
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
azoxystrobin
will
occupy
10%
of
the
aPAD
for
the
U.
S.
population,
17%
of
the
aPAD
for
children
1
 
2
years
old,
9%
of
the
aPAD
for
females
13
years
and
older,
and
10%
of
the
aPAD
for
adults
50+
years
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
azoxystrobin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
Table
1
of
this
unit:

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

U.
S.
Population
....................................................................................
0.67
10
170
3.1
21,000
Children
1
 
2
years
old
.........................................................................
0.67
17
170
3.1
5,600
Females
13
 
49
years
..........................................................................
0.67
9
170
3.1
18,000
Adults
(
50+
years)
...............................................................................
0.67
10
170
3.1
21,000
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
azoxystrobin
from
food
will
utilize
12%
of
the
cPAD
for
the
U.
S.
population,
22%
of
the
cPAD
for
children
1
 
2
years
old,
11%
of
the
cPAD
for
females
13
 
49
years
old,
and
11%
for
adults
50+
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
azoxystrobin
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
azoxystrobin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
2:

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

U.
S.
Population
....................................................................................
0.18
12
33
3.1
5,500
Children
1
 
2
years
...............................................................................
0.18
22
33
3.1
1,400
Females
13
 
49
years
..........................................................................
0.18
11
33
3.1
4,800
Adults
50+
years
..................................................................................
0.18
11
33
3.1
5,600
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).
Azoxystrobin
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
azoxystrobin.
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
1,200
for
adults,
and
430
for
children
1
 
2
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
azoxystrobin
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
the
following
Table
3:

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Rules
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Regulations
TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
AZOXYSTROBIN
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
....................................................................................
1,200
100
33
3.1
8,000
Children
1
 
2
years
old
.........................................................................
430
100
33
3.1
1,900
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).
Azoxystrobin
is
currently
registered
for
use(
s)
that
could
result
in
intermediate­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
intermediate­
term
exposures
for
azoxystrobin.
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
420
for
children
1
 
2
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
azoxystrobin
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
the
following
Table
4:

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

Children
1
 
2
years
old
.........................................................................
420
100
33
3.1
1,600
5.
Aggregate
cancer
risk
for
U.
S.
population.
There
is
no
evidence
for
mutagenicity
or
carcinogenicity.
Azoxystrobin
has
been
classified
as
``
not
likely
to
be
carcinogenic
in
humans''
by
EPA;
therefore,
azoxystrobin
is
not
expected
to
pose
a
carcinogenic
risk.
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
azoxystrobin
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
methodology
is
available
for
enforcement
of
these
tolerances.
The
gas
chromatography/
nitrogen
phosphorous
detector
(
GC/
NPD)
method
(
RAM
243/
04)
has
undergone
a
method
validation
by
the
EPA
analytical
laboratory.
EPA
comments
have
been
incorporated
and
the
revised
method
(
designated
RAM
243)
will
be
submitted
to
FDA
for
inclusion
in
PAM,
Volume
II
as
an
enforcement
method.
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
No
Codex,
Canadian,
or
Mexican
Maximum
Residue
Levels
(
MRLs)
have
been
established
for
residues
of
azoxystrobin.
Therefore,
no
tolerance
discrepancies
exist
between
countries
for
this
chemical.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
combined
residues
of
azoxystrobin,
methyl
(
E)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­ ­
(
methoxymethylene)­
benzeneacetate,
and
its
Z
isomer,
methyl
(
Z)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­ ­
(
methoxymethylene)­
benzeneacetate,
in
or
on
artichoke,
globe
at
4.0
ppm;
asparagus
at
0.04
ppm;
brassica,
head
and
stem,
subgroup
5A
at
3.0
ppm;
herb
subgroup
19A,
dried,
except
chive
at
260
ppm;
and
herb
subgroup
19A,
fresh,
except
chive
at
50
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.

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
 
0196
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
August
18,
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
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18,
2003
/
Rules
and
Regulations
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
 
0196,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
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Rules
and
Regulations
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
6,
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
180.507
is
amended
by
adding
alphabetically
commodities
to
the
table
in
paragraph
(
a)(
1)
to
read
as
follows:

§
180.507
Azoxystrobin;
tolerances
for
residues.
(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Artichoke,
globe
....................
4.0
Asparagus
.............................
0.04
*
*
*
*
*
Brassica,
head
and
stem,
subgroup
5A
......................
3.0
*
*
*
*
*
Herb
subgroup
19A,
dried,
except
chive
......................
260
Herb
subgroup
19A,
fresh,
except
chive
......................
50
*
*
*
*
*

*
*
*
*
*
[
FR
Doc.
03
 
15261
Filed
6
 
17
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Parts
257
and
258
[
FRL
 
7514
 
7]

RIN
2050
 
AE86
Criteria
for
Classification
of
Solid
Waste
Disposal
Facilities
and
Practices
and
Criteria
for
Municipal
Solid
Waste
Landfills:
Disposal
of
Residential
Lead­
Based
Paint
Waste
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
To
help
accelerate
the
pace
of
lead­
based
paint
removal
from
residences,
and
thereby
reduce
exposure
to
children
and
adults
from
the
health
risks
associated
with
lead,
EPA
is
promulgating
a
change
to
its
definition
of
``
municipal
solid
waste
landfill
unit''
in
both
the
Criteria
for
Classification
of
Solid
Waste
Disposal
Facilities
and
Practices
and
the
Criteria
for
Municipal
Solid
Waste
Landfills.
In
addition,
EPA
is
promulgating
two
new
definitions
for
``
construction
and
demolition
(
C&
D)
landfill''
and
``
residential
lead­
based
paint
waste.''
This
final
rule
will
expressly
allow
residential
lead­
based
paint
waste
that
is
exempted
from
the
hazardous
waste
management
requirements
as
household
waste
to
be
disposed
of
in
construction
and
demolition
landfills
by
stating
that
a
construction
and
demolition
landfill
accepting
residential
lead­
based
paint
waste,
and
no
other
household
waste,
is
not
a
municipal
solid
waste
landfill
unit.
Today's
action
would
not
prevent
a
municipal
solid
waste
landfill
unit
from
continuing
to
receive
residential
lead­
based
paint
waste.
DATES:
This
final
rule
will
become
effective
on
June
18,
2003.
The
Agency
finds
good
cause
to
make
this
rule
effective
immediately
because
today's
final
rule
provides
an
additional
disposal
option
for
residential
leadbased
paint
waste.
ADDRESSES:
Copies
of
the
documents
relevant
to
this
action
(
Docket
No.
RCRA
 
2001
 
0017)
are
available
for
public
inspection
during
normal
business
hours
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
federal
holidays,
at
the
RCRA
Information
Center
(
RIC),
located
at
EPA
West,
Room
B
 
102,
1301
Constitution
Ave.,
NW.
Washington,
DC.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information,
contact
the
RCRA
Hotline
at
(
800)
424
 
9346
or
TDD
(
800)
553
 
7672
(
hearing
impaired).
In
the
Washington,
DC,
metropolitan
area,
call
(
703)
412
 
9810
or
TDD
(
703)
412
 
3323.
For
information
on
specific
aspects
of
this
rule,
contact
Paul
Cassidy,
Municipal
and
Industrial
Solid
Waste
Division,
Office
of
Solid
Waste
(
mail
code
5306W),
U.
S.
Environmental
Protection
Agency
(
EPA,
HQ),
1200
Pennsylvania
Avenue,
NW,
Washington,
DC
20460;
(
703)
308
 
7281,
cassidy.
paul@
epa.
gov.
The
index
and
some
supporting
materials
are
available
on
the
Internet.
You
can
find
these
materials
at
http://
www.
epa.
gov/
epaoswer/
non­
hw/
muncpl/
landfill/
pbpaint
htm.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Regulated
Entities
Entities
potentially
covered
by
this
regulation
are
public
or
private
individuals
or
groups
that
generate
residential
lead­
based
paint
(
LBP)
waste
as
a
result
of
abatement,
rehabilitation,
renovation
and
remodeling
in
homes,
residences,
and
other
households.
By
``
households,''
we
mean
single
and
multiple
residences,
hotels
and
motels,
bunkhouses,
ranger
stations,
crew
quarters,
campgrounds,
picnic
grounds,
and
day­
use
recreation
areas.
Affected
categories
and
entities
include:

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