[
Federal
Register:
June
5,
2002
(
Volume
67,
Number
108)]
[
Notices]
[
Page
38660­
38664]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr05jn02­
42]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP­
2002­
0065;
FRL­
7177­
4]

Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.

DATES:
Comments,
identified
by
docket
control
number
OPP­
2002­
0065,
must
be
received
on
or
before
July
5,
2002.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP­
2002­
0065
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305­
7610;
e­
mail
address:
jackson.
Sidney@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Examples
of
Categories
NAICS
codes
potentially
affected
entities
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
  
Laws
and
Regulations,''
  
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
  
Federal
Register­­
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP­
2002­
0065.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.

C.
How
and
to
Whom
Do
I
Submit
Comments?

You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP­
2002­
0065
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e­
mail
to:
opp­
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
Wordperfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
control
number
OPP­
2002­
0065.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
That
I
Want
to
Submit
to
the
Agency?

Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
[[
Page
38661]]

information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
identified
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
May
17,
2002.
Robert
Forrest,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

III.
Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
section
408(
d)(
3)
of
the
FFDCA.
The
summary
of
the
petition
was
prepared
by
Valent
U.
S.
A.
Corporation,
P.
O.
Box
8025,
Walnut
Creek,
CA
94596­
8025
and
represents
the
view
of
Valent
U.
S.
A.
Corporation.
EPA
is
publishing
the
petition
summary
verbatim
without
editing
it
in
any
way.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

PP
1E6272,
1E6285,
and
2E6353
EPA
has
received
pesticide
petitions
(
PP)
1E6272,
1E6285,
and
2E6353
from
the
Interregional
Research
Project
Number
4
(
IR­
4),
Technology
Centre
of
New
Jersey,
Rutgers,
the
State
University
of
New
Jersey,
681
U.
S.
Highway
No.
1
South,
North
Brunswick,
NJ
08902­
3390
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
tolerances
for
residues
of
pyriproxyfen,
2­[
1­
methyl­
2­(
4­
phenoxyphenoxy)
ethoxy]
pyridine,
in
or
on
the
raw
agricultural
commodities
as
follows:
1.
PP
1E6272
proposes
tolerances
for
lychee,
longan,
Spanish
lime,
rambutan,
and
pulasan
at
0.3
parts
per
million
(
ppm).
2.
PP
1E6285
proposes
tolerances
for
guava,
feijoa,
jaboticaba,
wax
jambu,
starfruit,
passionfruit,
and
acerola
at
0.1
ppm,
and
3.
PP
2E6353
proposes
tolerances
for
Bushberry
subgroup
13
B
at
1.0
ppm
and
lingonberry,
juneberry,
and
salal
at
1.0
ppm.
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
Pyriproxyfen
is
manufactured
by
Sumitomo
Chemical
Company,
represented
in
the
United
States
by
Valent
U.
S.
A.
Corporation.

A.
Residue
Chemistry
1.
Plant
metabolism.
Metabolism
of
14C­
pyriproxyfen
labelled
in
the
phenoxyphenyl
ring
and
in
the
pyridyl
ring
has
been
studied
in
cotton,
apples,
tomatoes,
lactating
goats,
laying
hens
and
rats.
The
major
metabolic
pathways
in
plants
is
aryl
hydroxylation
and
cleavage
of
the
ether
linkage,
followed
by
further
metabolism
into
more
polar
products
by
further
oxidation
and/
or
conjugation
reactions.
However,
the
bulk
of
the
radiochemical
residue
on
raw
agricultural
commodities
(
RAC)
samples
remained
as
parent.
Comparing
metabolites
detected
and
quantified
from
cotton,
apple,
tomato,
goat,
hen
and
rat
shows
that
there
are
no
significant
aglycones
in
plants
which
are
not
also
present
in
the
excreta
or
tissues
of
animals.
The
residue
of
concern
is
best
defined
as
the
parent,
pyriproxyfen.
Ruminant
and
poultry
metabolism
studies
demonstrated
that
transfer
of
administered
14C­
residues
to
tissues
was
low.
Total
14C­
residues
in
goat
milk,
muscle
and
tissues
accounted
for
less
than
2%
of
the
administered
dose,
and
were
less
than
1
ppm
in
all
cases.
In
poultry,
total
14C
residues
in
eggs,
muscle
and
tissues
accounted
for
about
2.7%
of
the
administered
dose,
and
were
less
than
1
ppm
in
all
cases
except
for
gizzard.
2.
Analytical
method.
Practical
analytical
methods
for
detecting
and
measuring
levels
of
pyriproxyfen
(
and
relevant
metabolites)
have
been
developed
and
validated
in/
on
all
appropriate
agricultural
commodities,
respective
processing
fractions,
milk,
animal
tissues,
and
environmental
samples.
The
extraction
methodology
has
been
validated
using
aged
radiochemical
residue
samples
from
metabolism
studies.
The
methods
have
been
validated
in
cottonseed,
apples,
soil,
and
oranges
at
independent
laboratories.
EPA
has
successfully
validated
the
analytical
methods
for
analysis
of
cottonseed,
pome
fruit,
nutmeats,
almond
hulls,
and
fruiting
vegetables.
The
limit
of
detection
of
pyriproxyfen
in
the
methods
is
0.01
ppm
which
will
allow
monitoring
of
food
with
residues
at
the
levels
proposed
for
the
tolerances.
3.
Magnitude
of
residues
­­
i.
Lychee.
Three
lychee
field
residue
trials
were
conducted
in
1998
in
EPA
Region
13.
Each
field
site
received
two
pyriproxyfen
applications
at
0.11
lb
active
ingredient/
acre
(
a.
i./
A),
with
an
interval
of
10
to
11
days
between
applications,
and
a
preharvest
interval
of
11
to
13
days.
Pyriproxyfen
residues
on
treated
lychee
samples
ranged
from
[[
Page
38662]]

0.0759
to
0.272
ppm.
These
data
support
a
tolerance
for
pyriproxyfen
in
or
on
lychee
of
0.3
ppm.
ii.
Guava.
Three
guava
field
residue
trials
were
conducted
in
1999
in
EPA
Region
13.
Each
field
site
received
two
pyriproxyfen
applications
at
0.11
lb
a.
i./
A,
with
an
interval
of
13
days
between
applications,
and
a
pre­
harvest
interval
of
14
to
15
days.
Pyriproxyfen
residues
on
treated
guava
samples
ranged
from
<
0.025
to
0.055
ppm.
The
data
support
a
tolerance
for
pyriproxyfen
in
or
on
guava
of
0.1
ppm.
iii.
Blueberry.
Eight
blueberry
field
residue
trials
were
conducted
in
1999.
Three
trials
were
conducted
in
EPA
Region
2,
three
trials
in
EPA
Region
5,
one
trial
in
EPA
Region
1,
and
one
trial
in
EPA
Region
12.
Each
field
site
received
two
pyriproxyfen
applications
at
0.1
lb
ai/
A
with
a
retreatment
interval
ranging
between
13
to
15
days.
At
seven
trial
locations
samples
were
collected
6
to
8
days
after
the
last
application.
At
one
trial
location,
samples
were
collected
at
2,
7,
10,
14
and
21
days
after
the
last
application.
Pyriproxyfen
residues
ranged
from
0.14
ppm
to
0.64
ppm
for
treated
samples
collected
6
to
8
days
after
the
last
application.
In
the
residue
decline
study,
pyriproxyfen
residues
ranged
from
0.10
ppm
to
0.22
ppm
in
treated
samples
collected
at
the
first
three
sampling
intervals,
declining
to
as
low
as
0.03
ppm
after
21
days
after
the
last
application.
These
data
support
a
tolerance
for
pyriproxyfen
in
or
on
blueberries
and
commodities
within
the
bushberry
subgroup
of
1.0
ppm.

B.
Toxicological
Profile
An
assessment
of
toxic
effects
caused
by
pyriproxyfen
is
discussed
in
Unit
III.
A.
and
Unit
III.
B.
of
the
Federal
Register
dated
April
4,
2001,
(
FRL­
6772­
4)
(
66
FR
17883).
1.
Animal
metabolism.
The
absorption,
tissue
distribution,
metabolism
and
excretion
of
14C­
labeled
pyriproxyfen
were
studied
in
rats
after
single
oral
doses
of
2
or
1,000
milligrams/
kilograms
body
weight
(
mg/
kg
bw)
(
phenoxyphenyl
and
pyridyl
label),
and
after
a
single
oral
dose
of
2
mg/
kg
bw,
phenoxyphenyl
label
only,
following
14
daily
oral
doses
at
2
mg/
kg
bw
of
unlabelled
material.
For
all
dose
groups,
most
(
88­
96%)
of
the
administered
radiolabel
was
excreted
in
the
urine
and
feces
within
two
days
after
radiolabeled
test
material
dosing,
and
92­
98%
of
the
administered
dose
was
excreted
within
seven
days.
Seven
days
after
dosing,
tissue
residues
were
generally
low,
accounting
for
no
more
than
0.3%
of
the
dosed
14C.
Radiocarbon
concentrations
in
fat
were
the
higher
than
in
other
tissues
analyzed.
Recovery
in
tissues
over
time
indicates
that
the
potential
for
bioaccumulation
is
minimal.
There
were
no
significant
sex
or
dose­
related
differences
in
excretion
or
metabolism.
2.
Metabolite
toxicology.
Metabolism
studies
of
pyriproxyfen
in
rats,
goats
and
hens,
as
well
as
the
fish
bioaccumulation
study
demonstrate
that
the
parent
is
very
rapidly
metabolized
and
eliminated.
In
the
rat,
most
(
88­
96%)
of
the
administered
radiolabel
was
excreted
in
the
urine
and
feces
within
2
days
of
dosing,
and
92­
98%
of
the
administered
dose
was
excreted
within
7
days.
Tissue
residues
were
low
7
days
after
dosing,
accounting
for
no
more
than
0.3%
of
the
dosed
14C.
Because
parent
and
metabolites
are
not
retained
in
the
body,
the
potential
for
acute
toxicity
from
in
situ
formed
metabolites
is
low.
The
potential
for
chronic
toxicity
is
adequately
tested
by
chronic
exposure
to
the
parent
at
the
maximum
tolerated
dose
(
MTD)
and
consequent
chronic
exposure
to
the
internally
formed
metabolites.
Seven
metabolites
of
pyriproxyfen,
4'­
OH­
pyriproxyfen,
5''­
OH­
pyriproxyfen,
desphenyl­
pyriproxyfen,
POPA,
PYPAC,
2­
OH­
pyridine
and
2,5­
diOH­
pyridine,
have
been
tested
for
mutagenicity,
via
Ames
Assay,
and
acute
oral
toxicity
to
mice.
All
seven
metabolites
were
tested
in
the
Ames
assay
with
and
without
S9
at
doses
up
to
5,000
micro­
grams
per
plate
or
up
to
the
growth
inhibitory
dose.
The
metabolites
did
not
induce
any
significant
increases
in
revertible
colonies
in
any
of
the
test
strains.
Positive
control
chemicals
showed
marked
increases
in
reverting
colonies.
The
acute
toxicity
to
mice
of
4'­
OH­
pyriproxyfen,
5''­
OH­
pyriproxyfen,
desphenyl­
pyriproxyfen,
POPA,
and
PYPAC
did
not
appear
to
markedly
differ
from
pyriproxyfen,
with
all
metabolites
having
acute
oral
Lethal
Dose
(
LD50)
values
greater
than
2,000
mg/
kg
bw.
The
two
pyridines,
2­
OH­
pyridine
and
2,5­
diOH­
pyridine,
gave
acute
oral
LD50
values
of
124
(
male)
and
166
(
female)
mg/
kg
bw,
and
1,105
(
male)
and
1,000
(
female)
mg/
kg
bw,
respectively.
3.
Endocrine
disruption.
Pyriproxyfen
is
specifically
designed
to
be
an
insect
growth
regulator
and
is
known
to
produce
juvenoid
effects
on
arthropod
development.
However,
this
mechanism­
of­
action
in
target
insects
and
some
other
arthropods
has
no
relevance
to
any
mammalian
endocrine
system.
While
specific
tests,
uniquely
designed
to
evaluate
the
potential
effects
of
pyriproxyfen
on
mammalian
endocrine
systems
have
not
been
conducted,
the
toxicology
of
pyriproxyfen
has
been
extensively
evaluated
in
acute,
sub­
chronic,
chronic,
developmental,
and
reproductive
toxicology
studies
including
detailed
histopathology
of
numerous
tissues.
The
results
of
these
studies
show
no
evidence
of
any
endocrine­
mediated
effects
and
no
pathology
of
the
endocrine
organs.
Consequently,
Valent
concludes
that
pyriproxyfen
does
not
possess
estrogenic
or
endocrine
disrupting
properties
applicable
to
mammals.

C.
Aggregate
Exposure
1.
Dietary
exposure.
An
evaluation
of
chronic
dietary
exposure
including
both
food
and
drinking
water
has
been
performed
for
the
U.
S.
population
and
various
sub­
populations
including
infants
and
children.
No
acute
dietary
endpoint
and
dose
was
identified
in
the
toxicology
data
base
for
pyriproxyfen,
therefore,
the
Valent
Corporation
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
acute
dietary
exposure.
i.
Food.
Chronic
dietary
exposure
to
pyriproxyfen
residues
was
calculated
for
the
U.
S.
population
and
25
population
subgroups
assuming
tolerance
level
residues,
processing
factors
from
residue
studies,
and
100%
of
the
crop­
treated.
The
analyses
included
residue
data
for
all
existing
uses,
pending
uses,
and
proposed
new
uses.
The
results
from
several
representative
subgroups
are
listed
below.
Chronic
exposure
to
the
overall
U.
S.
population
is
estimated
to
be
0.002984
mg/
kg
bw/
day,
representing
0.9%
of
the
Reference
Dose
(
RfD).
For
the
most
highly
exposed
sub­
population,
children
1
to
6
years
of
age,
exposure
is
calculated
to
be
0.007438
mg/
kg
bw/
day,
or
2.1%
of
the
RfD.
Generally
speaking,
the
Agency
has
no
cause
for
concern
if
total
residue
contribution
for
established
and
proposed
tolerances
is
less
than
100%
of
the
RfD.

Calculated
Chronic
Dietary
Exposures
to
the
Total
U.
S.
Population
and
Selected
Sub­
Populations
to
Pyriproxyfen
Residues
in
Food
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Exposure
(
mg/
kg
bw/
Population
Subgroup
day)
Percent
of
RfD
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
U.
S.
population
(
all
0.002984
0.853
seasons)
Children
(
1­
6
years)
0.007438
2.125
Non­
Nursing
infants
(<
1
year
0.006483
1.852
old)
All
infants
(<
1
year
old)
0.005604
1.601
Children
(
7­
12
years)
0.004159
1.188
[[
Page
38663]]

Females
(
13+/
nursing)
0.002964
0.847
Nursing
infants
(<
1
year
old)
0.002601
0.743
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ii.
Drinking
water.
Since
pyriproxyfen
is
applied
outdoors
to
growing
agricultural
crops,
the
potential
exists
for
pyriproxyfen
or
its
metabolites
to
reach
ground
or
surface
water
that
may
be
used
for
drinking
water.
Because
of
the
physical
properties
of
pyriproxyfen,
it
is
unlikely
that
pyriproxyfen
or
its
metabolites
can
leach
to
potable
ground
water.
To
quantify
potential
exposure
from
drinking
water,
surface
water
concentrations
for
pyriproxyfen
were
estimated
using
GENEEC
1.3.
The
average
56­
day
concentration
predicted
in
the
simulated
pond
water
was
0.16
parts
per
billion
(
ppb).
Using
standard
assumptions
about
body
weight
and
water
consumption,
the
chronic
exposure
to
pyriproxyfen
from
this
drinking
water
would
be
4.57
x
10­
6
and
1.6
x
10­
5
mg/
kg
bw/
day
for
adults
and
children,
respectively;
0.0046%
of
the
RfD
(
0.35
mg/
kg/
day)
for
children.
Based
on
this
worse
case
analysis,
the
contribution
of
water
to
the
dietary
risk
is
negligible.
2.
Non­
dietary
exposure.
Pyriproxyfen
is
currently
registered
for
use
on
residential
non­
food
sites.
Pyriproxyfen
is
the
active
ingredient
in
numerous
registered
products
for
flea
and
tick
control.
Formulations
include
foggers,
aerosol
sprays,
emulsifiable
concentrates,
and
impregnated
materials
(
pet
collars).
With
the
exception
of
the
pet
collar
uses,
consumer
use
of
pyriproxyfen
typically
results
in
acute
and
short­
term
intermittent
exposures.
No
acute
dermal,
or
inhalation
dose
or
endpoint
was
identified
in
the
toxicity
data
for
pyriproxyfen.
Similarly,
doses
and
endpoints
were
not
identified
for
short
and
intermediate
term
dermal
or
inhalation
exposure
to
pyriproxyfen.
The
Valent
Corporation
has
concluded
that
there
are
reasonable
certainties
of
no
harm
from
acute,
short­
term,
and
intermediate­
term
dermal
and
inhalation
occupational
and
residential
exposures
due
to
the
lack
of
significant
toxicological
effects
observed.
Chronic
residential
post­
application
exposure
and
risk
assessments
were
conducted
to
estimate
the
potential
risks
from
pet
collar
uses.
The
risk
assessment
was
conducted
using
the
following
assumptions:
application
rate
of
0.58
mg
active
ingredient
(
ai)/
day,
average
bw
for
a
1­
6
year
old
child
of
10
kg,
the
a.
i.
dissipates
uniformly
through
365
days
(
the
label
instruct
to
change
collar
once
a
year),
1%
of
the
active
ingredient
is
available
for
dermal
and
inhalation
exposure
per
day
(
assumption
from
Draft
EPA
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
December
18,
1997).
The
assessment
also
assumes
an
absorption
rate
of
100%.
This
is
a
conservative
assumption
since
the
dermal
absorption
was
estimated
to
be
10%.
The
estimated
chronic
term
MOE
was
61,000
for
children,
and
430,000
for
adults.
The
risk
estimates
indicate
that
potential
risks
from
pet
collar
uses
do
not
exceed
the
Agency's
level
of
concern.

D.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
requires
that
the
Agency
must
consider
  
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
  
other
substances
that
have
a
common
mechanism
of
toxicity.''
Available
information
in
this
context
include
not
only
toxicity,
chemistry,
and
exposure
data,
but
also
scientific
policies
and
methodologies
for
understanding
common
mechanisms
of
toxicity
and
conducting
cumulative
risk
assessments.
For
most
pesticides,
although
the
Agency
has
some
information
in
its
files
that
may
turn
out
to
be
helpful
in
eventually
determining
whether
a
pesticide
shares
a
common
mechanism
of
toxicity
with
any
other
substances,
EPA
does
not
at
this
time
have
the
methodologies
to
resolve
the
complex
scientific
issues
concerning
common
mechanism
of
toxicity
in
a
meaningful
way.
There
are
no
other
pesticidal
compounds
that
are
structurally
related
to
pyriproxyfen
and
have
similar
effects
on
animals.
In
consideration
of
potential
cumulative
effects
of
pyriproxyfen
and
other
substances
that
may
have
a
common
mechanism
of
toxicity,
there
are
currently
no
available
data
or
other
reliable
information
indicating
that
any
toxic
effects
produced
by
pyriproxyfen
would
be
cumulative
with
those
of
other
chemical
compounds.
Thus,
only
the
potential
risks
of
pyriproxyfen
have
been
considered
in
this
assessment
of
aggregate
exposure
and
effects.
Valent
will
submit
information
for
EPA
to
consider
concerning
potential
cumulative
effects
of
pyriproxyfen
consistent
with
the
schedule
established
by
EPA
at
62
FR
42020
(
Aug.
4,
1997)
and
other
subsequent
EPA
publications
pursuant
to
the
Food
Quality
Protection
Act.

E.
Safety
Determination
1.
U.
S.
population.
­­
i.
Chronic
dietary
exposure
and
risk
adult
sub­
populations.
The
results
of
the
chronic
dietary
exposure
assessment
described
above
demonstrate
that
estimates
of
chronic
dietary
exposure
for
all
existing,
pending
and
proposed
uses
of
pyriproxyfen
are
well
below
the
chronic
RfD
of
0.35
mg/
kg
bw/
day.
The
estimated
chronic
dietary
exposure
from
food
for
the
overall
U.
S.
population
and
many
non­
child/
infant
subgroups
is
from
0.002123
to
0.003884
mg/
kg
bw/
day,
0.607
to
1.100%
of
the
RfD.
Addition
of
the
small
but
worse
case
potential
chronic
exposure
from
drinking
water
(
calculated
above)
increases
exposure
by
only
4.57
x
10­
6
mg/
kg
bw/
day
and
does
not
change
the
maximum
occupancy
of
the
RfD
significantly.
Generally,
the
Agency
has
no
cause
for
concern
if
total
residue
contribution
is
less
than
100%
of
the
RfD.
Valent
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
overall
U.
S.
Population
or
any
non­
child/
infant
subgroups
from
aggregate,
chronic
dietary
exposure
to
pyriproxyfen
residues.
ii.
Acute
dietary
exposure
and
risk
adult
sub­
populations.
No
acute
dietary
endpoint
and
dose
were
identified
in
the
toxicology
data
base
for
pyriproxyfen;
therefore,
it
can
be
concluded
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
overall
U.
S.
population
or
any
non­
child/
infant
subgroups
from
aggregate,
acute
dietary
exposure
to
pyriproxyfen
residues.
iii.
Non­
dietary
exposure
and
aggregate
risk
adult
sub­
populations.
Acute,
short
term,
and
intermediate
term
dermal
and
inhalation
risk
assessments
for
residential
exposure
are
not
required
due
to
the
lack
of
significant
toxicological
effects
observed.
The
results
of
a
chronic
residential
post­
application
exposure
and
risk
assessment
for
pet
collar
uses
demonstrate
that
potential
risks
from
pet
collar
uses
do
not
exceed
the
Agency's
level
of
concern.
The
estimated
chronic
term
MOE
for
adults
was
430,000.
2.
Infants
and
children
­­
i.
Safety
factor
for
infants
and
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
pyriproxyfen,
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
margin
of
safety,
up
to
10­
fold,
for
added
protection
for
infants
and
children
in
the
case
of
threshold
effects
unless
EPA
determines
[[
Page
38664]]

that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
The
toxicological
data
base
for
evaluating
pre­
natal
and
post­
natal
toxicity
for
pyriproxyfen
is
complete
with
respect
to
current
data
requirements.
There
are
no
special
prenatal
or
postnatal
toxicity
concerns
for
infants
and
children,
based
on
the
results
of
the
rat
and
rabbit
developmental
toxicity
studies
or
the
2­
generation
reproductive
toxicity
study
in
rats.
Valent
concludes
that
reliable
data
support
use
of
the
standard
100­
fold
uncertainty
factor
and
that
an
additional
uncertainty
factor
is
not
needed
for
pyriproxyfen
to
be
further
protective
of
infants
and
children.
ii.
Chronic
dietary
exposure
and
risk
infants
and
children.
Using
the
conservative
exposure
assumptions
described
above,
the
percentage
of
the
RfD
that
will
be
utilized
by
chronic
dietary
(
food
only)
exposure
to
residues
of
pyriproxyfen
ranges
from
0.002601
mg/
kg
bw/
day
for
nursing
infants,
up
to
0.007438
mg/
kg
bw/
day
for
children
(
1
to
6
years
of
age),
0.743
to
2.125%
of
the
RfD,
respectively.
Adding
the
worse
case
potential
incremental
exposure
to
infants
and
children
from
pyriproxyfen
in
drinking
water
(
1.6
x
10­
5
mg/
kg
bw/
day)
does
not
materially
increase
the
aggregate,
chronic
dietary
exposure
and
only
increases
the
occupancy
of
the
RfD
by
0.0046%
to
2.130%
for
Children
(
1
to
6
years
of
age).
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Valent
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate,
chronic
dietary
exposure
to
pyriproxyfen
residues.
iii.
Acute
dietary
exposure
and
risk
infants
and
children.
No
acute
dietary
endpoint
and
dose
were
identified
in
the
toxicology
data
base
for
pyriproxyfen;
therefore,
Valent
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate,
acute
dietary
exposure
to
pyriproxyfen
residues.
iv.
Non­
dietary
exposure
and
aggregate
risk
infants
and
children.
Acute,
short
term,
and
intermediate
term
dermal
and
inhalation
risk
assessments
for
residential
exposure
are
not
required
due
to
the
lack
of
significant
toxicological
effects
observed.
The
results
of
a
chronic
residential
post­
application
exposure
and
risk
assessment
for
pet
collar
uses
demonstrate
that
potential
risks
from
pet
collar
uses
do
not
exceed
the
Agency's
level
of
concern.
The
estimated
chronic
term
MOE
for
children
was
61,000.

F.
International
Tolerances
There
are
no
presently
existing
Codex
maximum
residue
levels
(
MRLs)
for
pyriproxyfen.

[
FR
Doc.
02­
13810
Filed
6­
4­
02;
8:
45
am]
BILLING
CODE
6560­
50­
S
