Document ID: EPA-HQ-OPP-2002-0319-0001
Agency: epa
Document Type: Proposed Rule
Title: Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in
or on Food
Posted Date: 2002-12-06T05:00Z

72675
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0319;
FRL
 
7281
 
9]

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
ID
number
OPP
 
2002
 
0319,
must
be
received
on
or
before
January
6,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Bipin
Gandhi,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8380;
e­
mail
address:
gandhi.
bipin@
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,
pesticide
manufacturer,
or
antimicrobial
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:

 
Industry
(
NAICS
111),
e.
g.,
Crop
Production.

 
Industry
(
NAICS
112),
e.
g.,
Animal
Production.

 
Industry
(
NAICS
311),
e.
g.,
Food
manufacturing.

 
Industry
(
NAICS
32532),
e.
g.,
Pesticide
Manufacturing.

 
Industry
(
NAICS
32561),
e.
g.,
Antimicrobial
Pesticide.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0319.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e­

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/
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No.
235
/
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December
6,
2002
/
Notices
mail
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2002
 
0319.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2002
 
0319.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2002
 
0319.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2002
 
0319.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
To
the
Agency?

Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
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
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
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
ID
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
FFDCA
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:
November
20,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
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.

3E6523
EPA
has
received
a
pesticide
petition
(
PP
3E6523)
from
Akzo
Nobel
Industrial
Specialties,
Inc.,
15200
Almeda
Road,
Houston,
TX
77053
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.960
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
a­
Hydro­
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles.
EPA
has
determined
that
the
petition
contains
data
or
information
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Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
Analytical
method.
Akzo
Nobel
is
petitioning
that
a­
hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
be
exempt
from
the
requirement
of
a
tolerance
based
upon
the
definition
of
a
low
risk
polymer
under
40
CFR
723.250(
e).
Therefore,
an
analytical
method
to
determine
residues
of
ahydro
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates
in
raw
agricultural
commodities
(
RACs)
is
not
required.

B.
Toxicological
Profile
As
part
of
the
EPA
policy
statement
on
inert
ingredients,
the
Agency
set
forth
a
list
of
studies
which
would
generally
be
used
to
evaluate
the
risks
posed
by
the
presence
of
an
inert
ingredient
in
a
pesticide
formulation.
However,
where
it
can
be
determined
without
the
data
that
the
inert
ingredient
will
present
minimal
or
no
risk,
the
Agency
generally
does
not
require
some
or
all
of
the
required
studies
to
rule
on
the
proposed
tolerance
or
exemption
from
the
requirement
of
a
tolerance
for
an
inert
ingredient.
Akzo
Nobel
Industrial
Specialties,
Inc.
believes
that
the
data
and
the
information
described
below
are
adequate
to
ascertain
the
toxicology
and
characterize
the
risk
associated
with
the
use
of
a­
hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
which
represent
C8
alkyl
ether
citrate
(
CAS
Registration
Number:
330977
 
00
 
9),
C10­
C16
alkyl
ether
citrates
(
CAS
Registration
Number:
330985
 
58
 
5)
and
C16­
C18­
alkyl
ether
citrates
(
CAS
Registration
Number:
330985
 
61
 
0)
as
inert
ingredients
in
pesticide
formulations.
In
the
case
of
certain
chemical
substances
that
are
defined
as
``
polymers''
the
EPA
has
established
a
set
of
criteria
which
identify
categories
of
polymers
that
present
low
risk.
These
criteria
(
codified
in
40
CFR
723.250)
identify
polymers
that
are
relatively
unreactive
and
stable
compared
to
other
chemical
substances
as
well
as
polymers
that
are
not
readily
absorbed.
These
properties
generally
limit
a
polymer's
ability
to
cause
adverse
effects.
In
addition,
these
criteria
exclude
polymers
about
which
little
is
known.
The
EPA
believes
that
polymers
meeting
the
criteria
noted
below
will
present
minimal
or
no
risk.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
which
represent
C8
alkyl
ether
citrate
(
CAS
Registration
Number:
330977
 
00
 
9),
C10­
C16
alkyl
ether
citrates
(
CAS
Registration
Number:
330985
 
58
 
5)
and
C16­
C18­
alkyl
ether
citrates
(
CAS
Registration
Number:
330985
 
61
 
0)
conform
to
the
definition
of
a
polymer
given
in
40
CFR
723.250(
b)
and
meet
the
following
criteria
that
are
used
to
identify
low
risk
polymers.
1.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
are
not
cationic
polymers,
nor
are
they
reasonably
anticipated
to
become
cationic
polymers
in
a
natural
aquatic
environment.
2.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
contain
as
an
integral
part
of
their
composition
the
atomic
elements
carbon,
oxygen,
and
hydrogen.
3.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
do
not
contain
as
an
integral
part
of
their
composition
any
elements
other
those
listed
in
40
CFR
723.250(
d)(
2)(
ii).
4.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
are
not
designed,
nor
are
they
reasonably
anticipated
to
substantially
degrade,
decompose,
or
depolymerize.
5.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
are
not
manufactured
or
imported
from
monomers
and/
or
other
reactants
that
are
not
already
included
on
the
Toxic
Substances
Control
Act
(
TSCA)
Chemical
Substance
Inventory
or
manufactured
under
an
applicable
TSCA
section
5
exemption.
6.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
are
not
water
absorbing
polymers.
7.
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
do
not
contain
any
group
as
reactive
functional
groups.
8.
The
minimum
number­
average
molecular
weights
of
polymers
represented
by
a­
hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
are
listed
as
shown
below:

 
C8
alkyl
ether
citrate
(
CAS
Registration
Number:
330977
 
00
 
9)
1,300
daltons
 
C10­
C16
alkyl
ether
citrates
(
CAS
Registration
Number:
330985
 
58
 
5)
1,100
daltons
 
C16­
C18­
alkyl
ether
citrates
(
CAS
Registration
Number:
330985
 
61
 
0)
1,300
daltons
Substances
with
molecular
weights
greater
than
400
generally
are
not
absorbed
through
the
intact
skin,
and
substances
with
molecular
weights
greater
than
1,000
generally
are
not
absorbed
through
the
intact
gastrointestinal
(
GI)
tract.
Chemicals
not
absorbed
through
the
skin
or
GI
tract
generally
are
incapable
of
eliciting
a
toxic
response.
9.
The
polymers
represented
by
ahydro
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates
have
numberaverage
molecular
weights
greater
than
1,100
and
contain
less
than
10%
oligomeric
material
below
molecular
weight
of
500
and
less
than
25%
oligomeric
material
below
1,000
molecular
weight.
In
addition,
the
monomers/
reactants
that
are
used
for
the
production
of
polymers
represented
by
a­
hydro­
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates
have
prior
clearances
by
the
Food
and
Drug
Administration
(
FDA)
under
21
CFR
for
food
contact
applications,
and
by
the
Environmental
Protection
Agency
under
40
CFR
for
use
in
pesticide
formulations
applied
to
raw
agricultural
commodities
(
RAC).
1.
Citric
acid
(
CAS
Registration
Number:
77
 
92
 
9)
was
affirmed
by
FDA
as
generally
recognized
as
safe
(
GRAS)
under
21
CFR
184.1033
for
use
in
food
for
human
consumption.
2.
Citric
acid
(
CAS
Registration
Number:
77
 
92
 
9)
is
cleared
under
40
CFR
180.1001(
c)
and
(
e)
as
an
inert
ingredient
in
pesticide
formulations
applied
to
RAC.
It
is
included
in
Inerts
­
List
4A.
3.
Fatty
alcohols
are
widely
present
in
oils,
fats
and
waxes
which
are
used
in
human
food.
Some
waxes
(
bees
wax,
candelilla
wax
and
carnauba
wax)
are
GRAS
substances
(
21
CFR
Part
184).
Bees
wax
and
carnauba
wax
are
in
Inerts
­
List
4B.
4.
C8­
C18
Alcohols
are
List
3
inerts.
Ethoxylated
C10­
C16
alcohols
(
CAS
Registration
Number:
68002
 
97
 
1)
and
ethoxylated
C16­
C18
alcohols
(
CAS
Registration
Number:
68439
 
49
 
6)
are
included
in
Inerts
­
List
3.
Ethoxylated
C9­
C16
alcohols
(
CAS
Registration
Number:
97043
 
91
 
9)
are
in
Inerts
­
List
4B.

C.
Aggregate
Exposure
Although
exposure
to
three
polymers
represented
by
a­
hydro­
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates
may
occur
through
dietary
sources,
the
chemical
characteristics
of
these
polymers
lead
to
the
conclusion
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
these
polymers.

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Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
products
applied
to
food
crops.
EPA
has
also
established
exemptions
from
tolerance
for
polymeric
materials
used
as
pesticide
inert
ingredients
that
it
considers
to
be
intrinsically
safe
based
on
the
fact
that
they
are
listed
on
the
TSCA
Inventory
or
meet
the
requirements
of
the
amended
TSCA
polymer
exemption
and
are
thereby
not
subject
to
the
requirements
of
the
premanufacturing
notification.
Any
exposure
resulting
from
the
approval
of
three
polymers
represented
by
a­
hydro­
 ­
hydroxypoly
oxyethylene)
C8­
C18­
alkyl
ether
citrates
in
pesticide
formulations
for
use
on
growing
crops
or
to
RAC
after
harvest
is
not
warranted.

D.
Cumulative
Effects
At
this
time
there
is
no
information
to
indicate
that
any
toxic
effects
produced
by
three
polymers
represented
by
ahydro
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates
having
a
number
average
molecular
weight
of
at
least
1,100
would
be
cumulative
with
those
of
any
other
chemical
substance(
s).
Given
the
categorization
of
these
polymers
as
a
``
low
risk
polymer''
(
40
CFR
723.250)
and
their
proposed
use
as
inert
ingredients
in
pesticide
formulations,
there
is
no
reasonable
expectation
of
increased
risk
due
to
cumulative
exposure.

E.
Safety
Determination
1.
U.
S.
population.
As
a
matter
of
policy,
EPA
has
in
the
past
established
exemptions
from
tolerance
for
polymeric
substances
used
as
pesticide
inert
ingredients
that
it
considers
to
be
intrinsically
safe
based
on
the
fact
that
they
are
listed
on
the
TSCA
Inventory
or
meet
the
requirements
of
the
amended
TSCA
polymer
exemption
and
are
thereby
not
subject
to
the
requirements
of
premanufacture
notice
(
PMN).
The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
formulations.
2.
Infants
and
children.
FFDCA
section
408
provides
that
EPA
shall
supply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
where
prenatal
and/
or
postnatal
toxicity
are
found
or
there
is
incompleteness
of
the
database,
unless
EPA
concludes
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
the
use
of
margin
of
exposure
(
MOE)
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
Due
to
the
low
expected
toxicity
of
these
three
polymers
represented
by
ahydro
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
a
safety
factor
analysis
is
not
required
for
assessing
the
risk.
For
the
same
reasons
the
additional
safety
factor
is
unnecessary.

F.
International
Tolerances
Akzo
Nobel
Industrial
Specialties,
Inc.
is
not
aware
of
any
country
requiring
a
tolerance
for
the
three
polymers
represented
by
a­
hydro­
 ­
hydroxy­
poly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates
having
a
number
average
molecular
weights
of
at
least
1,100.
Nor
have
there
been
any
CODEX
Maximum
Residue
Levels
(
MRLs)
established
for
any
food
crops
at
this
time.

[
FR
Doc.
02
 
30946
Filed
12
 
5
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0211;
FRL
 
7283
 
3]

Imazethapyr;
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
ID
number
OPP
 
2002
 
0211,
must
be
received
on
or
before
January
6,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
5697;
e­
mail
address:
tompkins.
jim@
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:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
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
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
 
0211.
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/.
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
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