Document ID: EPA-HQ-OPP-2002-0345-0001
Agency: epa
Document Type: Rule
Title: Pyriproxyfen; Pesticide Tolerance
Posted Date: 2003-03-07T05:00Z

10972
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Rules
and
Regulations
EPA
 
APPROVED
IOWA
REGULATIONS
 
Continued
Iowa
citation
Title
State
effective
date
EPA
approval
date
Comments
*
*
*
*
*
*
*

Chapter
22
 
Controlling
Pollution
567
 
22.1
......................
Permits
Required
for
New
or
Existing
Stationary
Sources.
7/
17/
02
3/
7/
03
and
FR
page
citation
Subrules
22.1(
2),
22.1(
2)
``
g,''
22.1(
2)
``
i''
have
a
state
effective
date
of
5/
23/
01.

*
*
*
*
*
*
*
567
 
22.3
......................
Issuing
Permits
..............................................
4/
24/
02
3/
7/
03
and
FR
page
citation
Subrule
22.3(
6)
is
not
SIP
approved.

*
*
*
*
*
*
*
567
 
22.201
..................
Eligibility
for
Voluntary
Operating
Permits
....
4/
24/
02
3/
7/
03
and
FR
page
citation
*
*
*
*
*
*
*
567
 
22.300
..................
Operating
Permit
by
Rule
for
Small
Sources
4/
24/
02
3/
7/
03
and
FR
page
citation
Subrule
22.300(
7)
``
c''
has
a
state
effective
date
of
10/
14/
98.

*
*
*
*
*
*
*

Chapter
25
 
Measurement
of
Emissions
567
 
25.1
......................
Testing
and
Sampling
of
New
and
Existing
Equipment.
4/
24/
02
3/
7/
03
and
FR
page
citation
*
*
*
*
*
*
*

*
*
*
*
*

PART
70
 
[
AMENDED]

1.
The
authority
citation
for
part
70
continues
to
read
as
follows:

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

2.
Appendix
A
to
part
70
is
amended
by
adding
under
``
Iowa''
paragraph
(
e)
to
read
as
follows:

Appendix
A
to
Part
70
 
Approval
Status
of
State
and
Local
Operating
Permits
Programs
*
*
*
*
*
Iowa
*
*
*
*
*
(
e)
The
Iowa
Department
of
Natural
Resources
submitted
for
program
approval
rules
``
567
 
22.100,''
``
567
 
22.101,''
``
567
 
22.201,''
and
``
567
 
22.300''
on
April
25,
2002.
The
state
effective
date
of
these
rules
is
April
24,
2002.
These
revisions
to
the
Iowa
program
are
approved
effective
May
6,
2003.

*
*
*
*
*
[
FR
Doc.
03
 
5310
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0345;
FRL
 
7289
 
6]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
pyriproxyfen
in
or
on
Brassica,
head
and
stem,
subgroup
5A,
Brassica,
leafy
greens,
subgroup
5B,
vegetable,
cucurbit
group
9,
olives
and
olive
oil.
Valent
U.
S.
A.
Corporation
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
March
7,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0345,
must
be
received
on
or
before
May
6,
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:
Joseph
M.
Tavano,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6411;
e­
mail
address:
tavano.
joseph@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAICS
111),
Crop
production.
 
Industry
(
NAICS
112),
Animal
production.
 
Industry
(
NAICS
311),
Food
manufacturing
 
Industry
(
NAICS
32532),
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
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Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Rules
and
Regulations
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
 
2002
 
0345
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
May
29,
2002
(
67
FR
37426
 
37432)
(
FRL
 
7178
 
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
a
pesticide
petition
PP
2F6385
by
Valent
U.
S.
A.
Corporation,
1333
North
California
Blvd.,
Suite
600,
P.
O.
Box
8025,
Walnut
Creek,
CA
94596
 
8025.
That
notice
included
a
summary
of
the
petition
prepared
by
Valent
U.
S.
A.
Corporation.
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.510
be
amended
by
establishing
a
tolerance
for
residues
of
the
insecticide,
pyriproxyfen,
2­[
1­
methyl­
2­(
4­
phenoxyphenoxy)
ethoxypyridine,
in
or
on
Brassica
leafy
vegetables
(
Crop
Group
5);
vegetable,
cucurbit
(
Crop
Group
9);
olive
and
olive,
oil
at
2.5,
0.1,
1.0,
and
3.0
parts
per
million
(
ppm)
respectively.
Based
on
the
residue
data
submitted,
EPA
has
determined
that
the
following
changes
to
the
requested
tolerances
listed
in
this
document
are
necessary.
A
lower
tolerance
of
2.0
ppm
is
required
for
olive,
oil.
Brassica
vegetables
are
devided
into
two
subgroups.
A
tolerance
of
0.70
is
required
for
Brassica,
head
and
stem,
subgroup
5A.
A
tolerance
of
2.0
ppm
is
required
for
Brassica,
leafy
greens,
subgroup
5B.
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
a
tolerance
for
residues
of
pyriproxyfen
on
Brassica,
head
and
stem,
subgroup
5A;
Brassica,
leafy
greens,
subgroup
5B;
Vegetable,
cucurbit
(
Group
9);
olive
and
olive,
oil
at
0.70,
2.0,
0.10,
1.0,
and
2.0
ppm,
respectively.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

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

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Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Rules
and
Regulations
TABLE
1.
 
TOXICITY
PROFILE
OF
PYRIPROXYFEN
TECHNICAL
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.3100
90­
Day
oral
toxicity
rodents
 
mouse
43210504
(
1990)
Acceptable/
guideline
0;
200;
1,000;
5,000;
or
10,000
ppm
M:
0,
28.2,
149.4,
838.1,
or
2,034.5
milligram/
kilogram/
day
(
mg/
kg/
day)
F:
0,
37.9,
196.5,
963.9,
or
2,345.3
mg/
kg/
day
NOAEL
=
149.4
mg/
kg/
day
in
males
(
M),
196.5
mg/
kg/
day
in
females
(
F)
LOAEL
=
838.1
mg/
kg/
day
(
M),
963.9
mg/
kg/
day
(
F)
based
on
pathological
changes
in
the
kidney,
increased
absolute
and
relative
(
to
body)
liver
weight,
decreased
red
blood
cell
parameters
(
both
sexes),
and
decreased
body
weight
gain
(
M)

870.3100
90­
Day
oral
toxicity
rodents
 
rat
41321716
(
1989)
Acceptable/
guideline
0;
400;
2,000;
5,000;
or
10,000
ppm
M:
0,
23.49,
117.79,
309.05,
or
641.81
mg/
kg/
day
F:
0,
27.68,
141.28,
356.30,
or
783.96
mg/
kg/
day
NOAEL
=
23.49
mg/
kg/
day
(
M),
27.68
mg/
kg/
day
(
F)
LOAEL
=
117.79
mg/
kg/
day
(
M),
141.28
based
on
increased
total
cholesterol
and
phospholipids
(
M),
decreased
red
blood
cell,
hematocrit,
and
hemoglobin
counts,
increased
relative
(
to
body)
liver
weight
(
M),
and
negative
trend
in
red
blood
cell
volume
(
F)

870.3150
90­
Day
oral
toxicity
nonrodents
 
dog
42178307
(
1988)
Acceptable/
guideline
0,
100,
300,
or
1,000
mg/
kg/
day
NOAEL
=
100
mg/
kg/
day
(
M)
and
(
F)
LOAEL
=
300
mg/
kg/
day
(
M)
and
(
F)
based
on
increased
absolute
and
relative
(
to
body)
liver
weight
(
both
sexes),
and
hepatocyte
enlargement
(
F)

870.3200
21­
Day
dermal
toxicity
 
rat
43994102
(
1993)
Acceptable/
guideline
0,
100,
300,
or
1,000
mg/
kg/
day
NOAEL
=
1,000
mg/
kg/
day
(
M)
and
(
F)
LOAEL
=
not
established
870.3265
28­
Day
inhalation
toxicity
 
rat
42178308
(
1988)
Supplementary
0,
269,
482,
or
1,000
mg/
meter
cubed
(
m3)
0,
0.269,
0.482,
or
1.000
mg/
liter
(
L)
NOAEL
=
0.482
mg/
L
(
M)
and
(
F)
LOAEL
=
1.000
mg/
L
based
on
salivation
(
both
sexes),
sporadic
decreased
body
weight
(
M),
and
increased
lactate
dehydrogenase
(
M)

870.3700a
Prenatal
developmental
 
rats
(
non­
guideline)
44985002
(
1988)
Acceptable/
nonguideline
0,
100,
300,
500,
or
1,000
mg/
kg/
day
Parental
NOAEL
=
100
mg/
kg/
day
Parental
LOAEL
=
300
mg/
kg/
day
based
on
clinical
signs,
decreased
body
weight
gains,
increased
water
consumption
(
both
sexes)
and
increased
food
consumption,
changes
in
organ
weights,
and
gross
pathological
changes
(
M)
Developmental
NOAEL
=
1,000
mg/
kg/
day
highest
dose
tested
(
HDT)

870.3700a
Prenatal
developmental
 
rats
(
non­
guideline)
44985001
(
1988)
Acceptable/
nonguideline
0,
30,
100,
300,
or
500
mg/
kg/
day
Maternal
NOAEL
=
100
mg/
kg/
day
Maternal
LOAEL
=
300
mg/
kg/
day
based
on
clinical
signs,
decreased
body
weight
gains,
and
decreased
food
consumption
Developmental
NOAEL
=
100
mg/
kg/
day
Developmental
LOAEL
=
300
mg/
kg/
day
based
on
decreased
body
weight
and
increased
incidence
of
dilation
of
the
renal
pelvis.

870.3700b
Prenatal
developmental
 
rabbit
41321720,
42178311,
43215401,
43215402,
43215403
(
1989)
Acceptable
guideline
0,
100,
300,
or
1,000
mg/
kg/
day
Maternal
NOAEL
=
100
mg/
kg/
day
Maternal
LOAEL
=
300
mg/
kg/
day
based
on
premature
delivery/
abortions,
soft
stools,
emaciation,
lusterless
fur,
decreased
activity,
and
bradypnea.
Developmental
NOAEL
=
300
mg/
kg/
day
Developmental
LOAEL
=
1,000
mg/
kg/
day
based
on
decreased
viable
litters
available
for
evaluation
870.3700a
Prenatal
developmental
 
rat
42178312
(
1988)
Acceptable/
guideline
0,
100,
300,
or
1,000
mg/
kg/
day
Maternal
NOAEL
=
100
mg/
kg/
day
Maternal
LOAEL
=
300
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption
and
increased
water
consumption
.
Developmental
NOAEL
=
300
mg/
kg/
day
Developmental
LOAEL
=
1,000
mg/
kg/
day
based
on
increased
incidence
of
skeletal
variations
at
gestation
day
21
and
unspecified
visceral
variations
at
postnatal
day
(
PND)
56.

870.3800
Reproduction
and
fertility
effects
 
rat
42178313
(
1991)
Acceptable/
guideline
0;
200;
1,000;
or
5,000
ppm
M:
0,
18,
87,
or
453
mg/
kg/
day
F:
0,
20,
96,
or
498
mg/
kg/
day
Parental/
Systemic
NOAEL
=
87
mg/
kg/
day
(
M),
96
mg/
kg/
day
(
F)
Parental/
Systemic
LOAEL
=
453
mg/
kg/
day
(
M),
498
mg/
kg/
day
(
F)
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption
(
both
sexes)
and
increased
liver
weight
(
both
sexes)
and
histopathological
lesions
of
liver
and
kidneys
(
M)
Reproductive
NOAEL
=
453
mg/
kg/
day
(
M),
498
mg/
kg/
day
(
F)
Reproductive
LOAEL
=
not
established.
Offspring
NOAEL
=
87
mg/
kg/
day
(
M),
96
mg/
kg/
day
(
F)
Offspring
LOAEL
=
453
mg/
kg/
day
(
M),
498
mg/
kg/
day
(
F)
based
on
decreased
body
weight
on
lactation
days
14
and
21
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7,
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/
Rules
and
Regulations
TABLE
1.
 
TOXICITY
PROFILE
OF
PYRIPROXYFEN
TECHNICAL
 
Continued
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.4100b
Chronic
toxicity
 
dogs
42178309
(
1991)
Acceptable/
guideline
0,
30,
100,
300,
or
1,000
mg/
kg/
day
NOAEL
=
100
mg/
kg/
day
(
M)
and
(
F)
LOAEL
=
300
mg/
kg/
day
(
M),
300
mg/
kg/
day
(
F)
based
on
decreased
body
weight
gain
and
increased
relative
liver
weight
(
both
sexes)
and
increased
cholesterol
and
triglycerides
and
decreased
red
cell
counts
and
hemoglobin
in
males
870.4300
Chronic/
Carcinogenicity
 
rats
42178314,
43210501,
43210502,
43210503
(
1991)
Acceptable/
guideline
0,
120,
600,
or
3,000
ppm
M:
0,
5.42,
27.31,
or
138.0
mg/
kg/
day
F:
0,
7.04,
35.1,
or
182.7
mg/
kg/
day
NOAEL
=
138
mg/
kg/
day
(
M),
35.1
mg/
kg/
day
(
F)
LOAEL
=
not
established
in
males,
182.7
mg/
kg/
day
(
F)
based
on
decreases
in
body
weight
gain
No
evidence
of
carcinogenicity
870.4200
Carcinogenicity
 
mice
42178310
(
1991)
Acceptable/
guideline
0,
120,
600,
or
3,000
ppm
M:
0,
16.8,
84.0,
or
420
mg/
kg/
day
F:
0,
21.9,
109.5,
or
547
mg/
kg/
day
NOAEL
=
84
mg/
kg/
day
(
M),
109.5
mg/
kg/
day
(
F)
LOAEL
=
420
mg/
kg/
day
(
M),
547
mg/
kg/
day
(
F)
based
on
renal
lesions
(
M)
and
(
F)
No
evidence
of
carcinogenicity
870.5265
Gene
mutation
44503506
(
1995)
Acceptable/
guideline
Non­
mutagenic
when
tested
up
to
5,000
micrograms
(
mg)/
plate
or
cytotoxic
levels,
in
presence
and
absence
of
activation;
in
S.
typhimurium
strains
TA98,
TA100,
TA1535,
and
TA1537;
and
in
E.
coli
strain
WP2uvra
with
2­
OH­
PY
(
metabolite
of
pyriproxyfen).

870.5265
Gene
mutation
44503507
(
1993)
Acceptable/
guideline
Non­
mutagenic
when
tested
up
to
5,000
mg/
plate
or
cytotoxic
levels,
in
presence
and
absence
of
activation;
in
S.
typhimurium
strains
TA98,
TA100,
TA1535,
and
TA1537;
and
in
E.
coli
strain
WP2uvra
with
4'
 
OH­
PY,
5 
 
OH­
PYR,
DPH­
PYR,
POPA,
and
PYPAC
(
metabolites
of
pyriproxyfen).

870.5265
Gene
mutation
44503508
(
1995)
Acceptable/
guideline
Non­
mutagenic
when
tested
up
to
5,000
mg/
plate
or
cytotoxic
levels,
in
presence
and
absence
of
activation;
in
S.
typhimurium
strains
TA98,
TA100,
TA1535,
and
TA1537;
and
in
E.
coli
strain
WP2uvra
with
2,5­
OH­
PY
(
metabolite
of
pyriproxyfen).

870.5265
Gene
mutation
42178315
(
1988)
Acceptable/
guideline
Non­
mutagenic
when
tested
up
to
5,000
mg/
plate
or
cytotoxic
levels,
in
presence
and
absence
of
activation;
in
S.
typhimurium
strains
TA98,
TA100,
TA1535,
TA1537,
and
TA1538;
and
in
E.
coli
strain
WP2uvra
with
2­
OH­
PY
(
pyriproxyfen
technical).

870.5300
Gene
mutation
42178316
(
1990)
Acceptable/
guideline
Non­
mutagenic
at
the
HGPRT
locus
in
Chinese
hamster
lung
V79
cells
tested
up
to
cytotoxic
concentrations
or
limit
of
solubility,
in
presence
and
absence
of
activation.

870.5375
Chromosome
aberration
41321722
(
1989)
Acceptable/
guideline
Did
not
induce
structural
chromosome
aberration
in
Chinese
hamster
ovary
(
CHO)
cell
cultures
in
the
absence
or
presence
of
activation.

870.5550
Unscheduled
DNA
synthesis
42178317
(
1988)
Acceptable/
guideline
There
was
no
evidence
that
unscheduled
DNA
synthesis,
as
determined
by
radioactive
tracer
procedures
(
nuclear
silver
grain
counts)
was
induced
in
HeLa
cells
exposed
up
to
cytotoxic
levels,
both
in
the
presence
or
absence
of
S­
9.

870.7485Metabolism
and
pharmacokinetics
 
rat
42178318
(
1988)
Acceptable/
guideline
Rats
were
orally
dosed
with
14C­
labeled
pyriproxyfen
at
2
or
1,000
mg/
kg
and
at
repeated
oral
doses
(
14
daily
doses)
of
unlabeled
pyriproxyfen
at
2
mg/
kg
followed
by
administration
of
a
single
oral
dose
of
labeled
pyriproxyfen
at
2
mg/
kg.
Most
radioactivity
was
excreted
in
the
feces
(
81
 
92%)
and
urine
(
5
 
12%)
over
a
7
day
collection
period.
Expired
air
containing
CO2
was
not
detected.
Tissue
radioactivity
levels
were
very
low
(
less
than
0.3%)
except
for
fat.
Examination
of
urine,
feces,
liver,
kidney,
bile,
and
blood
metabolites
yielded
numerous
(>
20)
identified
metabolites
when
compared
to
synthetic
standards.
The
major
biotransformation
reactions
of
pyriproxyfen
include:
1.
Oxidation
of
the
4'
 
position
of
the
terminal
phenyl
group.
2.
Oxidation
at
the
5'
 
position
of
pyridine.
3.
Cleavage
of
the
ether
linkage
and
conjugation
of
the
resultant
phenols
with
sulfuric
acid.

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Rules
and
Regulations
B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factors
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
A
summary
of
the
toxicological
endpoints
for
pyriproxyfen
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
PYRIPROXYFEN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
females
13
 
50
years
old
and
general
population
None
None
An
appropriate
endpoint
attributable
to
a
single
oral
dose
was
not
available
in
the
data
base,
including
maternal
toxicity
in
the
developmental
toxicity
studies.

Chronic
Dietary
all
populations
NOAEL=
35.1
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.35
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
cRfD
÷
FQPA
SF
=
0.35
mg/
kg/
day
Subchronic
toxicity
and
chronic
toxicity
(
feeding)
 
rat
(
co­
critical)
LOAEL
=
141.28
mg/
kg/
day
based
on
decreased
body
weight
and
clinical
pathology
results.

Short­
Term
Incidental,
Oral
(
1
 
30
days)
Residential
Oral
Maternal
NOAEL
=
100
mg/
kg/
day
LOC
for
MOE
=
100
Rat
developmental
toxicity
study
Maternal
LOAEL
=
300
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption,
and
increased
water
consumption
Intermediate­
Term
Incidental,
Oral
(
1
 
6
months)
Residential
Oral
NOAEL
=
35.1
mg/
kg/
day
LOC
for
MOE
=
100
Subchronic
toxicity
and
chronic
toxicity
(
feeding)
 
rat
(
co­
critical)
LOAEL
=
141.28
mg/
kg/
day
based
on
decreased
body
weight
and
clinical
pathology
results.

Short­,
and
Intermediate­
Term
Dermal
(
1
 
30
days
and
1
 
6
months)
(
Occupational/
Residential)
None
None
Based
on
the
systemic
toxicity
NOAEL
of
1,000
mg/
kg/
day
(
limit
dose)
in
the
21
day
dermal
toxicity
study
in
rats,
quantification
of
dermal
risks
is
not
required.
In
addition,
no
developmental
concerns
(
toxicity)
were
seen
in
either
rats
or
rabbits.

Long­
Term
Dermal
(
6
monthslifetime
(
Occupational/
Residential)
Oral
NOAEL=
35.1
mg/
kg/
day
(
dermal
absorption
rate
=
30%)
LOC
for
MOE
=
100
Subchronic
and
chronic
toxicity
(
feeding)
 
rat
(
co­
critical)
LOAEL
=
141.28
mg/
kg/
day
based
decreased
body
weight
and
clinical
pathology
results
Short­,
and
Intermediate­
Term
Inhalation
(
1
 
30
days
and
1
 
6
months)
(
Occupational/
Residential)
None
None
Based
on
the
absence
of
significant
toxicity
at
the
LOAEL
of
1.0
mg/
L
(
limit
dose),
the
quantification
of
inhalation
risks
is
not
required
In
addition,
no
developmental
concerns
(
toxicity)
were
seen
in
either
rats
or
rabbits.

Long­
Term
Inhalation
(
6
months
 
lifetime)
(
Occupational/
Residential)
Oral
study
NOAEL=
35.1
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
Subchronic
and
chronic
toxicity
(
feeding)
 
rat
(
co­
critical)
LOAEL
=
141.28
mg/
kg/
day
based
on
decreased
body
weight
and
clinical
pathology
results
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Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
PYRIPROXYFEN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
oral,
dermal,
inhalation)
Cancer
classification
(``
Group
E'')
Risk
Assessment
not
required
No
evidence
of
carcinogenicity
1
UF
=
uncertainty
factor,
FQPA
SF
=
Food
Quality
Protection
Act
safety
factor,
NOAEL
=
no­
observed­
adverse­
effect­
level,
LOAEL
=
lowestobserved
adverse­
effect­
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose,
LOC
=
level
of
concern,
MOE
=
margin
of
exposure
*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.510)
for
the
residues
of
pyriproxyfen,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
pyriproxyfen
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.
An
aRfD
for
females
13
 
50
years
old
and
the
general
population,
including
infants
and
children,
was
not
selected
because
an
acute
oral
endpoint
attributed
to
a
single­
dose
exposure
could
not
be
identified
in
any
of
the
toxicology
data
base,
including
maternal
toxicity
in
the
developmental
toxicity
studies.
Thus,
the
risk
from
acute
exposure
is
considered
negligible.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCIDTM),
version
1.3
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
United
States
Department
of
Agricluture
(
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:
a.
A
tier
1
(
assumptions:
Tolerance
level
residues
and
100
percent
crop
treated
(
PCT)
was
conducted.
b.
The
established
tolerances
of
40
CFR
180.510
and
the
new
tolerances
established
in
this
document
were
included
in
the
analysis.
c.
Anticipated
residues
and
PCT
were
not
used
in
this
analysis.
d.
The
processing
factors
applied
were
the
DEEM
default
values.
For
chronic
dietary
risk,
EPA's
level
of
concern
is
>
100%
cPAD.
Dietary
exposure
estimates
for
representative
population
subgroups
are
presented
in
Table
3
of
this
unit.
The
results
of
the
chronic
analysis
indicate
that
the
estimated
chronic
dietary
risk
associated
with
the
existing
and
EPArecommended
uses
of
pyriproxyfen
is
below
EPA's
level
of
concern.

TABLE
3.
 
SUMMARY
OF
RESULTS
FROM
CHRONIC
DEEMTM
ANALYSIS
OF
PYRIPROXYFEN
Subgroup
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
(
total)
0.003836
1.1
All
Infants
(<
1
year
old)
0.006852
2.0
Children
1
 
2
years
old
0.013707
3.9
Children
3
 
5
years
old
0.010107
2.9
Children
6
 
12
years
old
0.005969
1.7
Youth
13
 
19
years
old
0.003389
1.0
Adults
20
 
49
years
old
0.002658
0.8
Females
13
 
49
years
old
0.002702
0.8
Adults
50+
years
old
0.002676
0.8
iii.
Cancer.
In
accordance
with
the
Agency's
1986
Guidelines
for
Carcinogenic
Risk
Assessment,
the
RfD/
Peer
Review
Committee
classified
pyriproxyfen
as
a
``
Group
E''
chemicalnegative
for
carcinogenicity
to
humans.
This
classification
is
based
on
the
lack
of
evidence
of
carcinogenicity
in
mice
and
rats.
iv.
Anticipated
residue
and
PCT
information.
Anticipated
residues
and
PCT
information
was
not
used
in
the
Agency's
assessment.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
pyriproxyfen
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
pyriproxyfen.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(
GENEEC)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCIGROW
which
predicts
pesticide
concentrations
in
groundwater.
In
general,
EPA
will
use
GENEEC
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
The
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.

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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
pyriproxyfen
they
are
further
discussed
in
the
aggregate
risk
in
Unit
III.
E.
Pyriproxyfen
is
relatively
long­
lived
in
soil
and
water,
with
variable
halflives
of
approximately
2
weeks
to
2
months.
Pyriproxyfen
is
immobile,
as
indicated
by
the
relative
mobility
scheme
in
Dragun
(
1998)
for
five
soils
and
one
sediment.
The
registrant
determined
the
half­
lives,
6.8
and
9
days,
respectively,
for
the
phenyl­
label
and
pyridyl­
label
portions
of
pyriproxyfen.
Since
there
is
only
one
value,
the
longest
half­
life
(
9
days)
was
multiplied
by
3
using
EFED
input
guidance.
Thus,
the
aerobic
soil
half­
life
in
the
modeling
assessment
was
27
days.
EPA
determined
that
the
residue
of
concern
in
water
is
pyriproxyfen
per
se.
Drinking
water
estimates
include
surface
water
EDWCs
based
on
the
linked
PRZM/
EXAMS
models
and
the
SCI­
GROW
groundwater
regression
model,
which
was
developed
from
studies
with
different
hydrology
and
study
conditions.
Both
models
assumed
a
maximum
seasonal
application
rate
of
0.11
lb
active
ingredient
(
ai)/
acre
(
A),
3
times
per
year
(
citrus
and
stone
fruit).
Based
on
the
PRZM/
EXAMS
model
the
EECs
of
pyriproxyfen
for
surface
water
was
estimated
to
be
2.15
parts
per
billion
(
ppb)
for
the
peak
concentration,
and
0.40
ppb
for
the
long
term
average.
Based
on
the
SCI­
GROW
model
the
EECs
of
pyriproxyfen
for
groundwater
was
estimated
to
be
0.006
ppb
for
both
the
acute
and
chronic
exposure.
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).
Pyriproxyfen
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
Flea
and
tick
control
(
home
environment
and
pet
treatments)
as
well
as
products
for
ant
and
roach
control
(
indoor
and
outdoor
applications).
Formulations
include
carpet
powders,
foggers,
aerosol
sprays,
liquids
(
shampoos,
sprays,
and
pipettes
for
pet
treatments),
granules,
bait
(
indoor
and
outdoor),
and
impregnated
materials
(
pet
collars).
There
is
a
potential
for
short­
term
dermal
and
inhalation
exposures
to
pet
owners
and
homeowners
who
apply
products
containing
pyriproxyfen
(
handlers);
however,
EPA
did
not
select
short­
term
dermal
or
inhalation
endpoints.
Therefore,
due
to
the
lack
of
toxicity
observed
in
animal
testing,
no
residential
pet
owner/
homeowner
handler
risk
of
concern
is
expected.
Toddlers
could
potentially
be
exposed
to
pyriproxyfen
residues
on
treated
carpets,
floors,
furniture,
and
pets.
There
is
potential
for
exposure
expected
for
the
following
scenarios:
i.
Hand­
to­
mouth.
Short­,
intermediate­,
and
long­
term
hand­
tomouth
exposures
by
toddlers
from
treated
carpets,
flooring
(
note
the
efficacy
of
carpet
powders
is
approximately
365
days).
ii.
Hand­
to­
mouth.
Short­
and
intermediate­
term
hand­
to­
mouth
exposures
by
toddlers
from
petting
treated
animals
(
shampoos,
sprays,
spoton
treatments,
and
collars).
Long­
term
hand­
to­
mouth
exposures
by
toddlers
from
petting
treated
animals
(
pet
collars;
note
efficacy
of
pet
collars
up
to
395
days).
iii.
Dermal.
Long­
term
dermal
exposures
from
treated
carpets,
flooring,
and
pets
(
note
that
treated
furniture
is
included
in
the
carpet/
flooring
assessment).
Due
to
the
lack
of
toxicity
observed
in
animal
testing,
the
Agency
did
not
select
any
short­
or
intermediate­
term
dermal
endpoints
and
no
dermal
risk
of
concern
for
these
durations
is
expected.
A
long­
term
dermal
assessment
is
included,
since
EPA
selected
a
long­
term
dermal
endpoint.
iv.
Ingestion
of
granules
or
bait
by
toddlers
(
acute,
episodic
event).
For
the
granular
ingestion
scenario,
it
should
be
noted
that
the
Agency
believes
that
if
a
toddler
were
to
be
exposed
to
a
pellet/
granular
formulation
(
i.
e.,
ant
bait),
the
event
is
most
likely
to
be
``
episodic,''
that
is,
a
one­
time
occurrence
and
not
likely
to
be
repeated.
It
is
not
likely
that
a
toddler
would
repeatedly
locate
and
ingest
very
small,
sand
colored
granules.
For
pyriproxyfen,
EPA
did
not
select
an
acute
dietary
endpoint,
since
an
appropriate
endpoint
could
not
be
attributed
to
a
single­
oral
dose;
therefore,
no
acute
dietary
risk
of
concern
is
expected.
Exposure
and
risk
estimates
from
post­
application
exposure
to
indoor
crack
and
crevice
treatments
are
not
presented
in
this
assessment,
as
indoor
broadcast
treatments
(
i.
e.,
carpet
powders
and
sprays)
are
anticipated
to
have
a
higher
exposure
potential.
Additionally,
the
Agency
acknowledges
that
pet
owners
could
retreat
the
home
environment
and/
or
the
pet
near
the
end
of
the
efficacy
period
identified
on
the
product
labels.
However,
there
are
no
chemical­
specific
residue
data
for
pyriproxyfen
to
determine
the
dissipation
rate
of
residues
or
whether
residues
may
be
additive
upon
retreatment.
Therefore,
a
tier
1
assessment
was
performed
based
on
day
0
residues
without
accounting
for
daily
residue
dissipation.
EPA
anticipates
that
this
assessment
is
protective
as
pyriproxyfen
residues
would
be
expected
to
dissipate
from
day
0
residue
values.
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
pyriproxyfen
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
pyriproxyfen
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
pyriproxyfen
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

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

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2.
Prenatal
and
postnatal
sensitivity.
Based
on
the
available
data,
there
is
no
quantitative
and
qualitative
evidence
of
increased
susceptibility
observed
following
in
utero
pyriproxyfen
exposure
to
rats
and
rabbits
or
following
pre/
postnatal
exposure
in
the
2
 
generation
reproduction
study.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
pyriproxyfen
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
safety
factor
to
protect
infants
and
children
should
be
reduced
to
1X
because
there
was
no
evidence
of
prenatal
or
postnatal
extra
sensitivity
or
increased
susceptibility
in
developmental
studies
in
rats
and
rabbits,
and
in
reproduction
studies
in
rats.
Likewise,
there
was
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
to
rat
or
rabbit
fetuses
identified
in
the
guideline
prenatal
developmental
toxicity
studies
for
rats
and
rabbits.
Additionally,
in
the
two
non­
guideline
studies
that
evaluated
perinatal
and
prenatal
development,
there
was
no
evidence
of
quantitative
or
qualitative
increased
susceptibility.
In
one
study,
when
pregnant
rats
were
treated
from
gestation
day
17
to
lactation
day
20,
the
resulting
toxicity
was
comparable
between
adults
(
clinical
signs,
decreased
body
weight
gain
and
food
consumption)
and
offspring
(
decreased
body
weight
and
dilation
of
the
renal
pelvis)
at
the
same
dose.
In
the
other
study,
when
rats
were
exposed
to
pyriproxyfen
prior
to
and
in
the
early
stages
of
pregnancy,
no
developmental
toxicity
was
seen
at
the
limit
dose.
Lastly,
in
the
reproduction
toxicity
study,
offspring
toxicity
(
decreased
body
weight
on
pups
during
lactation
days
14
to
21)
occurred
only
in
the
presence
of
decreases
in
body
weight
in
parental
animals
at
the
same
dose
level
(
i.
e.,
comparable
toxicity
in
adults
and
offspring).
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
estimated
environmental
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
EPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
L/
70
kg
(
adult
male),
2
L/
60
kg
(
adult
female),
and
1
L/
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,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
An
acute
dietary
RfD
for
females
13
 
49
and
the
general
U.
S.
population,
including
infants
and
children,
was
not
selected
because
an
acute
oral
endpoint
attributable
to
a
single­
dose
exposure
could
not
be
identified
in
the
toxicology
data
base,
including
maternal
toxicity
in
the
developmental
toxicity
studies.
No
acute
dietary
risk
is
expected.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
pyriproxyfen
from
food
will
utilize
1.1%
of
the
cPAD
for
the
U.
S.
population,
2.0%
of
the
cPAD
for
all
infant,
s
and
3.9%
of
the
cPAD
for
children
1
 
2
years
old.
Pyriproxyfen
is
the
active
ingredient
in
many
registered
residential
products
for
flea
and
tick
control
on
pets
and
in
the
home
for
ant
and
roach
control
for
indoor
and
outdoor
applications.
Based
on
the
use
pattern,
the
residential
assessment
was
performed
for
toddlers
since
they
are
anticipated
to
have
the
higher
chronic
residential
exposure
to
residues
of
pyriproxyfen.
The
total
chronic
food
and
residential
aggregate
MOEs
range
from
850
to
13,000.
As
these
MOEs
are
greater
than
100,
the
chronic
aggregate
risk
does
not
exceed
EPA's
level
of
concern.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
pyriproxyfen
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
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
PYRIPROXYFEN
Population
Subgroup
Aggegate
MOE
(
Food
+
Residential)
Target
MOE
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
9,200
100
0.40
0.006
12,000
All
infants
1,000
100
0.40
0.006
3,200
Children
1
 
2
years
old
860
100
0.40
0.006
3,100
Children
3
 
5
years
old
940
100
0.40
0.006
10,000
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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).
Pyriproxyfen
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
pyriproxyfen.
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
26,000
for
the
U.
S.
population,
1,800
for
all
infants(<
1
year
old),
and
1,600
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
pyriproxyfen
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
PYRIPROXYFEN
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Target
MOE
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

U.
S.
population
26,000
100
0.40
0.006
35,000
All
infants
(<
1
year
old
1,800
100
0.40
0.006
9,400
Children
(
1
 
2
years
old)
1,600
100
0.40
0.006
9,400
Females
(
13
 
49
years
old)
37,000
00
0.40
0.006
30,000
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Pyriproxyfen
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
pyriproxyfen.
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
9,200
for
the
U.
S.
population,
650
for
all
infants
(<
1
year
old,
and
580
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
pyriproxyfen
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
intermediate­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
6
of
this
unit:

TABLE
6.
 
AGGREGATE
RISK
ASSESSMENT
FOR
INTERMEDIATE­
TERM
EXPOSURE
TO
PYRIPROXYFEN
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Target
MOE
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Intermediate
Term
DWLOC
(
ppb)

U.
S.
population
9,200
100
0.40
0.006
12,000
All
infants
(<
1
year
old)
650
100
0.40
0.006
3,000
Children
(
1
 
2
years
old)
580
100
0.40
0.006
3,000
Females
(
13
 
49
years
old)
13,000
100
0.40
0.006
10,000
5.
Aggregate
cancer
risk
for
U.
S.
population.
There
was
no
evidence
of
carcinogenicity
in
a
78­
week
mouse
feeding
study
and
a
2
 
year
rat
feeding
study.
Pyriproxyfen
was
classified
as
a
``
Group
E''
chemical
(
no
evidence
of
carcinogenicity
to
humans)
by
the
Agency
based
on
the
absence
of
evidence
of
carcinogenicity
in
male
and
female
rats
as
well
as
in
male
and
female
mice.
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
pyriproxyfen
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
In
conjunction
with
the
residue
studies
on
cabbage,
cauliflower,
mustard
greens,
cantaloupe,
cucumber,
summer
squash,
olive,
okra,
and
sugar
apple,
the
petitioner
submitted
adequate
concurrent
recovery
data
for
a
gas
chromatography/
nitrogen
phosphorous
detector
(
GC/
NPD)
method
(
RM
 
33P
 
1
 
3a)
used
to
determine
residues
of
pyriproxyfen
in/
on
these
crops.
The
method
has
undergone
an
adequate
radiovalidation,
independent
laboratory
validation
(
ILV)
trial,
petition
method
validation
(
PMV)
trial,
and
has
been
forwarded
to
the
Food
and
Drug
Administration
(
FDA)
for
inclusion
in
Pesticide
Analytical
Method
(
PAM)
Vol.
II
(
DP
Barcode
D257337,
W.
Donovan,
7/
1/
99).
HED
concludes
that
the
GC/
NPD
method
RM
 
33P
 
1
 
3a
is
adequate
for
enforcement
of
the
recommended
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Regulations
tolerance
levels
for
residues
of
pyriproxyfen
per
se
in/
on
Brassica
leafy
vegetables,
cucurbit
vegetables,
olive,
okra,
sugar
apple,
cherimoya,
atemoya,
custard
apple,
ilama,
soursop,
birba,
fig,
avocado,
papaya,
star
apple,
black
sapote,
mango,
sapodilla,
canistel,
and
mamey
sapote.
As
tolerances
for
residues
of
pyriproxyfen
in
livestock
commodities
are
not
required
at
this
time,
enforcement
methodology
for
determining
residues
in
livestock
are
not
required.
MRM
testing
data
have
previously
been
provided
(
PP#
6F04737,
DP
Barcode
D228556,
J.
Garbus,
5/
6/
97)
for
pyriproxyfen.
Pyriproxyfen
was
recovered
from
fortified
apple
and
cotton
samples
through
protocols
A,
C,
D,
E,
and
F.
The
results
have
been
forwarded
to
FDA.
Adequate
enforcement
methodology
(
example
 
gas
chromotography)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Francis
Griffith,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
email
address:
griffith.
francis@
epa.
gov.

B.
International
Residue
Limits
There
are
no
Codex,
Canadian,
or
Mexican
maximum
residue
limits
(
MRLs)
for
residues
of
pyriproxyfen
in/
on
any
of
the
crops
involved
in
the
proposed
new
uses.
Therefore,
international
harmonization
is
not
an
issue
at
this
time.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
residues
of
pyriproxyfen,
[
2­[
1­
methyl­
2­(
4­
phenoxyphenoxy)
ethoxy]
pyridine],
in
or
on
Brassica,
head
and
stem,
subgroup
5A;
Brassica,
leafy
greens,
subgroup
5B;
vegetable,
cucurbit,
group
9;
olive
and
olive,
oil
at
0.70,
2.0,
0.10,
1.0,
and
2.0
ppm.
respectively.

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
 
2002
 
0345
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
May
6,
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
telephone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to:
Mr.
Tompkins,
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
 
2002
 
0345,
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
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Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Rules
and
Regulations
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

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

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

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

Dated:
February
24,
2003.

Debra
Edwards,

Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

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

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

2.
Section
180.510
is
amended
by
alphabetically
adding
commodities
to
the
table
in
paragraph
(
a)(
1)
to
read
as
follows:

§
180.510
Pyriproxyfen;
tolerances
for
residues.

(
a)
*
*
*
(
1)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Brassica,
head
and
stem,
subgroup
5A
...............................
0.70
Brassica,
leafy
greens,
subgroup
5B
...............................
2.0
*
*
*
*
*
Olive
..........................................
1.0
Olive,
oil
....................................
2.0
*
*
*
*
*
Vegetable,
cucurbit,
group
9
....
0.10
*
*
*
*
*

*
*
*
*
*

[
FR
Doc.
03
 
5478
Filed
3
 
6
 
03;
8:
45
am]

BILLING
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