Document ID: EPA-HQ-OPP-2003-0235-0001
Agency: epa
Document Type: Notice
Title: Gellan Gum; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-16T04:00Z

42026
Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
E.
Safety
Determination
1.
U.
S.
population.
Using
the
exposure
assumptions
described
above,
BASF
has
estimated
that
chronic
dietary
aggregate
exposure
to
chlorfenapyr
for
the
U.
S.
population
was
0.002615
mg/
kg
bwt/
day
or
8.7%
of
the
chronic
RfD
of
0.03
mg/
kg
bwt/
day.
Other
than
children
less
than
12
years
of
age,
hispanics
are
the
U.
S.
population
subgroup
with
the
highest
chronic
exposure
of
0.003403
mg/
kg
bwt/
day,
or
11.3%
of
the
RfD.
EPA
has
no
concerns
about
exposure
that
are
less
than
100%
of
the
RfD
as
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
It
is
therefore,
safe
to
conclude
that
there
is
reasonable
certainty
that
no
harm
to
the
overall
U.
S.
population
will
result
from
chronic
exposure
to
chlorfenapyr
residues.
2.
Infants
and
children.
Using
the
exposure
assumption
described
above,
BASF
has
estimated
that
the
chronic
dietary
aggregate
exposure
to
chlorfenapyr
for
children
1
 
6
years
of
age
was
0.005936
mg/
kg
bwt/
day,
or
19.8%
of
the
chronic
RfD
of
0.03
mg/
kg
bwt/
day.
Children
1
 
6
years
of
age
were
the
sub­
population
that
utilized
the
largest
portion
of
the
chronic
RfD.
It
is
therefore,
safe
to
conclude
that
there
is
reasonable
certainty
that
no
harm
to
infants
and
children
will
result
from
chronic
exposure
to
chlorfenapyr
residues.

F.
International
Tolerances
No
Codex
or
Canadian
tolerances/
limits
for
residues
in
any
food
presently
exist
for
chlorfenapyr.
In
Mexico
there
is
a
MRL
of
0.3
ppm
for
cottonseed.
[
FR
Doc.
03
 
17900
Filed
7
 
15
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0235;
FRL
 
7317
 
4]

Gellan
Gum;
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
identification
(
ID)
number
OPP
 
2003
 
0235,
must
be
received
on
or
before
August
15,
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:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6304;
e­
mail
address:
boyle.
kathryn@
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:
 
Crop
production
(
NAICS
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0235.
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
EPA's
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
VerDate
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31>
2003
17:
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15,
2003
Jkt
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Sfmt
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E:\
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42027
Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
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
email
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
 
2003
 
0235.
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
 
2003
 
0235.
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
 
2003
 
0235.
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
 
2003
 
0235.
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
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Vol.
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/
Wednesday,
July
16,
2003
/
Notices
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:
July
7,
2003.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
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
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
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.

CP
Kelco
PP
3E6567
EPA
has
received
a
pesticide
petition
(
PP
3E6567)
from
CP
Kelco,
8355
Aero
Drive,
San
Diego,
CA
92123,
proposing
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
gellan
gum
(
CAS
Reg.
No.
71010
 
52
 
1)
in
or
on
all
raw
agricultural
commodities
(
RAC)
when
used
as
a
sticker/
thickener
in
seed
treatment
and
pesticide
formulations.
EPA
has
determined
that
the
petition
contains
data
or
information
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
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
As
a
polysaccharide
polymer,
gellan
gum
is
non­
systemic
and
therefore
no
metabolism
of
gellan
gum
in
raw
agricultural
commodities
or
processed
commodities
is
expected.
2.
Analytical
method.
Analytical
methods
for
determination
of
the
polysaccharide
polymer,
gellan
gum
are
available.
Gellan
gum
is
determined
by
the
dissolution
of
gellan
gum
containing
gels
by
heating
and
cooling
in
the
presence
of
a
dilute
sequestrant
solution
(
e.
g.
0.1%
w/
v
sodium
hexametaphosphate).
The
gellan
gum
assay
is
based
upon
the
presence
of
the
6­
deoxyhexose
rhamnose
which
can
be
determined
using
the
cysteine­
sulfuric
acid
procedure,
originally
developed
by
Dische
and
Shettles
and
modified
by
Graham.
3.
Magnitude
of
residues.
Gellan
gum
is
applied
as
a
minor
component
of
pesticidal
formulations.
Gellan
gum
degrades
into
simple
non­
toxic
sugars
and
their
salts.

B.
Toxicological
Profile
1.
Acute
toxicity.
The
acute
toxicity
of
gellan
gum
was
studied
using
male
and
female
rats
via
the
oral
and
inhalation
routes.
In
the
acute
oral
toxicity
study,
the
lethal
dose
(
LD)
50
for
both
males
and
females
was
established
at
>
5,000
milligrams/
kilogram
body
weight
(
mg/
kg
bwt).
For
the
acute
inhalation
toxicity
study,
the
LD50
for
both
males
and
females
was
established
at
>
5.09
milligrams/
Liter
(
mg/
L).
Gellan
gum
is
practically
non­
toxic
to
rats
when
administered
as
a
single
large
dose
(
5
g/
kg
bwt)
in
diet
or
via
gavage.
2.
Genotoxicity.
Gellan
gum
was
shown
to
be
non­
genotoxic
in
a
battery
of
standard
short­
term
tests.
The
Ames
test,
involving
S.
typhimurium
at
10,
30,
100,
300,
and
1,000
µ
g/
plate
resulted
in
a
negative
response.
A
deoxyribonucleic
acid
(
DNA)
repair
test
using
the
rat
hepatocyte
as
a
test
subject
at
3,
5,
10,
and
20
milligrams/
liter
(
mg/
L)
resulted
in
a
negative
response.
For
the
V
 
79/
hypoxanthine
guanine
phophoribosyl
transferase/(
HGPRT)
study,
involving
the
Chinese
hamster
lung
fibroblasts,
doses
at
3,
5,
10,
and
20
mg/
mL
resulted
in
a
negative
response.
3.
Reproductive
and
developmental
toxicity.
Groups
of
26
male
and
female
CD
(
Sprague­
Dawley)
rats
were
administered
gellan
gum
in
their
diets
at
doses
of
0,
2.5,
3.8,
or
5.0%.
Males
were
treated
for
70
days
prior
to
mating
and
for
3
weeks
after
mating.
Females
were
treated
for
14
days
prior
to
mating
and
throughout
mating,
gestation,
and
lactation.
Selection
was
made
for
the
pups
(
F1)
of
this
mating
and
they
were
allowed
to
mature
and
were
mated
to
form
the
F2
generation.
There
was
no
treatment­
related
effect
of
mating
or
fertility
index,
conception
rate,
length
of
gestation,
length
or
parturition,
number
of
live
pups,
number
of
dead
pups,
postimplantation
loss
index,
survival
index
on
day
4,
7,
14,
or
21
or
lactation
index
for
any
of
the
generations.
For
teratology
studies,
gellan
gum
was
fed
to
groups
of
25
pregnant
female
Sprague­
Dawley
rats
at
dietary
levels
of
0,
2.5,
3.8,
or
5.0%
during
days
6
 
15
of
gestation.
Gellan
gum
has
no
fetotoxic
or
teratogenic
effects
on
rats
when
ingested
in
the
diet
at
levels
up
to
5.0%.
In
the
reproduction
and
teratogenic
studies
in
rats
in
which
gellan
gum
was
given
at
doses
up
to
50
g/
kg
in
the
diet,
there
was
no
evidence
of
interference
with
the
reproductive
process,
and
no
embryotoxic
or
developmental
effects
were
observed.
4.
Subchronic
toxicity.
For
short­
term
studies,
male
and
female
Sprague­
Dawley
rats
(
20/
sex/
group)
were
fed
dietary
levels
of
gellan
gum
ranging
from
0
 
6%
for
13
weeks.
Although
the
animals
on
this
study
experienced
symptoms
of
a
sialodacryoadenitis
viral
infection,
all
animals
survived
treatment
and
there
were
no
adverse
effects
associated
with
the
feeding
of
gellan
gum
at
levels
up
to
60
gram/
kilogram
(
g/
kg).
Also,
prepubertal
rhesus
monkeys
(
2/
sex/
group)
were
dosed
by
oral
gavage
with
gellan
gum
at
levels
of
0,
1,
2,
or
3
g/
kg/
day
for
28
days.
There
were
no
overt
signs
of
toxicity
reported
at
levels
up
to
50
g/
kg
in
the
diet.
5.
Chronic
toxicity.
Groups
of
50
male
and
female
Swiss
Crl
mice
were
fed
gellan
gum
admixed
in
the
diet
at
0,
1.0,
2.0,
and
3.0%
for
96
and
98
weeks
for
males
and
females,
respectively.
All
animals
were
examined
twice
daily
for
mortality
and
morbidity.
Physical
examination
for
the
presence
of
palpable
masses
was
initiated
on
a
weekly
basis
starting
in
week
26.
Body
weights
and
food
consumption
were
measured
for
7
 
day
periods
on
a
weekly
basis
for
the
first
26
weeks
of
treatment
and
every
2
weeks
thereafter.
At
necropsy,
a
complete
gross
pathological
examination
was
performed
on
the
animals
from
the
control
and
3.0%
groups.
Only
the
liver,
kidneys,
ovaries,
testes,
adrenals,
pituitary,
lungs,
and
heart
were
examined
for
animals
of
the
1.0
and
2.0%
groups.
There
were
no
effects
attributable
to
the
feeding
of
gellan
gum
on
either
body
weight
gain
or
food
consumption.
There
were
no
neoplastic
or
non­
neoplastic
changes
which
were
associated
with
the
feeding
of
gellan
gum.
For
the
rat,
groups
of
50
F1
generation
Sprague­
Dawley
rats
of
each
sex
were
exposed
to
gellan
gum
in
utero
and
continued
on
gellan
gum
diets
for
approximately
104
weeks.
The
dietary
levels
of
gellan
gum
were
0,
2.5,
3.8,
and
5.0%.
The
rats
were
observed
daily
for
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136
/
Wednesday,
July
16,
2003
/
Notices
the
first
4
weeks
of
treatment
and
weekly
thereafter
for
clinical
signs
of
toxicity.
Individual
bodyweights
and
food
consumption
were
measured
on
a
weekly
basis
for
the
first
26
weeks
of
treatment
and
every
2
weeks
thereafter.
Fundoscopic
and
biomicroscopic
examinations
were
conducted
on
the
control
and
5%
groups
during
weeks
1,
13,
26,
52,
78,
and
103.
Clinical
chemistry
and
haematological
samples
were
collected
at
weeks
13,
25,
39,
and
51.
After
104
weeks,
ophthalmoscopic
examinations,
haematology,
clinical
chemistries
and
organ
weight
data
revealed
no
changes
which
could
be
attributed
to
the
feeding
of
gellan
gum.
Survival
of
male
treated
rats
was
poor
when
compared
to
controls
whereas
female
treated
rats
exhibited
better
survival
than
their
concurrent
controls.
Male
rats,
fed
gellan
gum
at
the
3.8
and
5.0%
dietary
levels,
exhibited
lower
body
weights
after
76
weeks.
The
initial
bodyweights
were
5.2
and
3.4%
lower
than
the
control
values
for
the
3.8
and
5.0%
dietary
levels,
respectively.
It
was
concluded
that
in
spite
of
the
initial
body
weight
deficit,
the
growth
pattern
for
these
treated
groups
was
identical
to
that
of
the
control.
In
addition,
this
effect
was
not
seen
in
either
the
females
or
any
other
species
tested.
There
is
no
basis
to
suggest
that
the
lower
body
weights,
observed
in
the
male
rats,
are
indicative
of
toxicity.
Organs
and
tissues
as
those
listed
in
the
mouse
study
were
examined
for
histopathological
changes
at
study
termination.
There
were
no
neoplastic
or
non­
neoplastic
changes
that
could
be
associated
with
the
feeding
of
gellan
gum.
The
authors
concluded
that
gellan
gum
is
non­
carcinogenic
to
Sprague­
Dawley
rats.
For
chronic
toxicity
study
on
dogs,
diets
containing
0,
3,
4.5,
and
6%
gellan
gum
were
fed
to
groups
of
5
Beagle
dogs
per
sex
for
a
period
of
52
weeks.
The
dogs
were
observed
daily
for
clinical
signs
of
toxicity
and
were
measured
for
body
weights
and
food
consumption.
Ophthalmoscopic
examinations
were
performed
during
pretreatment
and
after
12,
24,
29,
and
51
weeks.
Hematology
and
clinical
chemistry
were
measured
during
pretreatment
and
after
6,
13,
25,
39,
and
50
weeks.
After
52
weeks
all
animals
were
killed
and
grossly
examined.
All
animals
survived
treatment.
Food
intake
was
higher
in
the
treated
groups
compared
to
the
controls.
There
were
no
adverse
effects
associated
with
the
feeding
of
gellan
gum
to
beagle
dogs
for
a
period
1
 
year.
6.
Animal
metabolism.
The
adsorption,
distribution,
and
excretion
of
gellan
gum
was
studied
using
a
dually
radiolabeled
(
3H
and
14C)
preparation.
The
use
of
dual
labeling
allowed
simultaneous
quantitation
of
both
polysaccharide
and
``
protein''
fractions
of
gellan
gum.
One
male
and
one
female
Sprague­
Dawley
rat
were
gavaged
with
single
doses
of
the
3H/
14C­
gellan
gum
(
ca.
960
mg/
kg;
ca.
4
µ
Ci).
Expired
air
was
collected
24
hours
after
dosing.
Less
than
0.55%
of
the
given
radioactivity
was
detected
as
14C.
Four
male
and
three
female
Sprague­
Dawley
rats
were
dosed
with
single
gavage
dose
of
3H/
14C
 
gellan
gum
(
ca.
870
mg/
kg;
2.9
­
4.1
µ
Ci
14C;
0.7
­
0.9
µ
Ci
3H).
Urine
and
feces
were
collected
for
7
days,
at
which
time
the
animals
were
sacrificed
and
their
tissues
analyzed
for
residual
radioactivity.
Females
excreted
86.8%
and
1.9%
of
the
given
14C
in
the
feces
and
urine,
respectively.
Males
excreted
86%
of
the
dosed
14C
in
the
feces
and
3.3%
in
the
urine.
Females
excreted
4.1%
of
the
dosed
3H
in
their
urine
and
100.1%
in
their
feces,
while
males
excreted
3.6%
of
the
total
3H
in
their
urine
and
99.6%
in
their
feces.
In
all
animals,
the
activities
of
3H
in
tissues
(
blood,
brain,
liver,
kidney,
lung,
muscle,
skin,
heart,
and
carcass)
were
too
low
to
be
quantitated
accurately.
Tissue
and
carcass
radioactivity
for
14C
averaged
3.8%
of
dose
for
male
rats
and
3.0%
of
dose
for
female
rats.
A
male
and
four
female
Sprague­
Dawley
rats
were
gavaged
with
about
1
g/
kg
of
radiolabeled
gellan
gum
and
blood
samples
collected
from
the
tail
vein
at
different
time
intervals
over
a
7
 
day
period.
Data
were
reported
as
14C
dmp/
mL
blood
(
3H
dmp/
mL
blood
was
not
reported).
The
peak
level
of
radioactivity,
which
amounted
to
about
0.4%
of
the
administered
radioactivity,
occurred
about
5
hours
after
dosing.
Gellan
gum
was
shown
to
be
poorly
absorbed
and
did
not
cause
any
deaths
in
rats
which
received
a
single
large
dose
(
5
g/
kg
bwt)
in
the
diet
or
by
gavage.
7.
Metabolite
toxicology.
Gellan
gum
is
a
polysaccharide
polymer
composed
of
D­
mannopyranose
with
Dglucopyranose
and
6­
deoxy­
Lmannopyronose
calcium,
potassium,
and
sodium
salt.
Gellan
gum
metabolizes
into
simple
non­
toxic
sugars
and
their
salts.
8.
Endocrine
disruption.
Gellan
gum
does
not
belong
to
a
class
of
chemicals
known
or
suspected
of
having
adverse
effects
on
the
endocrine
system.
There
is
no
evidence
that
gellan
gum
has
any
effect
on
endocrine
function
in
developmental
or
reproduction
studies.
Furthermore,
histological
investigation
of
endocrine
organs
in
chronic
dog,
rat,
and
mouse
studies
did
not
indicate
that
the
endocrine
system
is
targeted
by
gellan
gum.

C.
Aggregate
Exposure
1.
Dietary
exposure.
As
a
minor
formulation
component,
there
is
no
reasonable
expectation
that
gellan
gum
will
appear
in
diet.
i.
Food.
Gellan
gum
is
approved
in
the
U.
S.
under
21
CFR
172.665
as
a
food
additive,
stabilizer,
and
thickener
in
batters,
breadings,
coatings,
glazes,
gravies,
and
sauces
for
meat
and
poultry
products.
As
a
minor
formulation
component,
there
is
no
reasonable
expectation
that
gellan
gum
will
appear
in
food
from
pesticide
uses.
ii.
Drinking
water.
As
a
minor
formulation
component,
there
is
no
reasonable
expectation
that
gellan
gum
will
appear
in
water.
2.
Non­
dietary
exposure.
The
only
non­
dietary
exposure
to
gellan
gum
will
be
exposure
through
treating
and
handling
of
treated
seeds
and
application
of
formulations
containing
gellan
gum.

D.
Cumulative
Effects
The
potential
for
cumulative
effects
of
gellan
gum
and
other
substances
that
have
a
common
mechanism
of
toxicity
has
also
been
considered.
Gellan
gum
is
a
high­
molecular­
weight
polysaccharide
gum
produced
by
a
pure­
culture
fermentation
of
a
carbohydrate
with
Sphingomonas
elodea.
There
is
no
reliable
information
to
indicate
that
toxic
effects
produced
by
gellan
gum
would
be
cumulative
with
those
of
any
other
chemical
including
another
pesticide.
Therefore,
CP
Kelco
believes
it
is
appropriate
to
consider
only
the
potential
risks
of
gellan
gum
in
an
aggregate
risk
assessment.

E.
Safety
Determination
1.
U.
S.
population.
The
occupational
exposure
to
gellan
gum
in
pesticide
formulations
during
distribution
and
storage
will
be
limited
to:
Workers
involved
in
the
transportation
of
gellan
gum
to
customers;
and
those
involved
in
the
loading
and
off­
loading
of
the
product
containers
from
commercial
carriers
and
during
opening
of
drums
containing
gellan
gum.
However,
the
potential
for
worker
exposure
is
expected
to
be
well
controlled
and
limited
if
worker­
safety
procedures
are
routinely
practiced.
The
potential
opportunity
for
human
exposure
to
gellan
gum
is
expected
to
be
limited
to
clean­
up
activities
during
routine
maintenance,
or
following
an
accidental
spill
or
release.
Exposures
occurring
during
these
activities
would
typically
be
minimized
by
the
accommodations
made
in
equipment
design
and
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Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
employee
work
practices.
As
long
as
the
recommended
practices
for
worker
protection
during
use
are
respected,
the
risk
of
worker
exposure
to
gellan
gum
in
an
occupational
setting
is
expected
to
be
of
minimal
significance.
2.
Infants
and
children.
The
exposure
to
gellan
gum
in
pesticide
formulations
is
limited
to
formulators
and
applicators.
Dietary
exposure
to
infants
and
children
does
not
differ
from
the
general
population.

F.
International
Tolerances
Gellan
gum
is
approved,
registered,
or
filed
as
a
food
additive
in
the
countries
of
Argentina,
Brazil,
Canada,
Chile,
Columbia,
Costa
Rica,
El
Salvador,
Guatemala,
Honduras,
Mexico,
Nicaragua,
Panama,
Paraguay,
Peru,
Uruguay,
Venezuela,
Egypt,
Hungary,
Israel,
Jordan,
Morocco,
Norway,
Pakistan,
Poland,
South
Africa,
Switzerland,
Tunisia,
Turkey,
Australia,
China,
Hong
Kong,
India,
Indonesia,
Japan,
Malaysia,
Malta,
New
Zealand,
Singapore,
South
Korea,
Sri
Lanka,
Taiwan,
Thailand,
the
Philippines,
and
Vietnam.
In
the
European
community,
gellan
gum
has
approval
(
E
 
418)
as
a
food
additive.
Purity
criteria
are
established
by
JECFA
(
Joint
Expert
Committee
on
Food
Additives).
[
FR
Doc.
03
 
17897
Filed
7
 
15
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S]

ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0225;
FRL
 
7314
 
7]

Zeta­
cypermethrin
and
its
inactive
isomers;
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
 
2003
 
0225,
must
be
received
on
or
before
August
15,
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:
Linda
A.
DeLuise,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5428;
e­
mail
address:
deluise.
linda@
epa.
gov@
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:
 
Crop
protection
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0225.
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
EPA's
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
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