Document ID: EPA-HQ-OPP-2003-0162-0001
Agency: epa
Document Type: Notice
Title: Rhamnolipid Biosurfactant; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-05-09T04:00Z

25026
Federal
Register
/
Vol.
68,
No.
90
/
Friday,
May
9,
2003
/
Notices
Summary:
No
formal
comment
letter
was
sent
to
the
preparing
agency.

Dated:
May
6,
2003.
Joseph
C.
Montgomery,
Director,
NEPA
Compliance
Division,
Office
of
Federal
Activities.
[
FR
Doc.
03
 
11633
Filed
5
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0162;
FRL
 
7306
 
3]

Rhamnolipid
Biosurfactant;
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
 
0162,
must
be
received
on
or
before
June
9,
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:
Denise
Greenway,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8263;
e­
mail
address:
greenway.
denise@
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
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
 
0162.
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.
1.
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
VerDate
Jan<
31>
2003
16:
10
May
08,
2003
Jkt
200001
PO
00000
Frm
00112
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09MYN1.
SGM
09MYN1
25027
Federal
Register
/
Vol.
68,
No.
90
/
Friday,
May
9,
2003
/
Notices
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
 
0162.
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
 
0162.
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
 
0162.
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
 
0162.
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:
April
29,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
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.

Jeneil
Biosurfactant
Company
PP
1F6288
EPA
has
received
a
pesticide
petition
1F6288
from
Jeneil
Biosurfactant
Company,
400
N.
Dekora
Woods
Boulevard,
Saukville,
Wisconsin
53080,
proposing
pursuant
to
section
408(
d)
of
VerDate
Jan<
31>
2003
16:
10
May
08,
2003
Jkt
200001
PO
00000
Frm
00113
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09MYN1.
SGM
09MYN1
25028
Federal
Register
/
Vol.
68,
No.
90
/
Friday,
May
9,
2003
/
Notices
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
biochemical
pesticide
rhamnolipid
biosurfactant
in
or
on
all
food
commodities.
Pursuant
to
section
408(
d)(
2)(
A)(
I)
of
the
FFDCA,
as
amended,
Jeneil
Biosurfactant
Company
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Jeneil
Biosurfactant
Company,
and
EPA
has
not
fully
evaluated
the
merits
of
the
pesticide
petition.
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.

A.
Product
Name
and
Proposed
Use
Practices
Rhamnolipid
biosurfactant
is
intended
for
the
prevention
and
control
of
plant
pathogenic
fungi
on
horticultural
and
agricultural
crops.
Fungal
diseases
are
often
spread
by
zoospores
that
are
transported
from
one
plant
to
another
and
from
field
to
field.
Rhamnolipid
biosurfactant
kills
zoospores
that
cause
fungal
disease,
on
contact.
Target
pests
are
any
zoosporic
plant
pathogenic
microorganisms
including
the
following
genera:
Plasmodiophora,
Polymyxa,
Spongospora,
Physoderma,
Olpidium,
Synchytrium,
Rhizophydium,
Achlya,
Aphanomyces,
Albugo,
Peronopythora,
Pachymetra,
Pythium,
Phytophthora,
Trachysphaera,
Basidiophora,
Peronosclerospora,
Plasmopara,
Pseudoperonospora,
Sclerophthora,
and
Sclerospora.
End­
use
formulations
of
rhamnolipid
biosurfactant
are
applied
through
conventional
equipment
as
a
spray,
fog,
drench
or
seed
soak
to
the
point
of
saturation,
and
can
also
be
incorporated
into
nutrient
solutions
for
hydroponic
plants
and
vegetables.
The
product
will
be
diluted
with
water
and
applied
to
growing
plants
and
agricultural
commodities
at
a
rate
of
70
to
100
parts
per
million
(
ppm).
One
enduse
formulation,
Zonix
Biofungicide
(
8.5%
active
ingredient),
is
proposed
at
this
time.

B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
Rhamnolipid
biosurfactant,
CAS
number:
147858
 
26
 
2;
CAS
name:
Decanoic
acid,
3­[[
6­
deoxy­
2­
O­(
6­
deoxy­
a­
Lmannopyranosyl
a­
L­
mannopyranosyl]
oxy]­,
1­
(
carboxymethyl)
octyl
ester,
mixture
with
1­(
carboxymethyl)
octyl
3­[(
6­
deoxy­
a­
Lmannopyranosyl
oxy]
decanoate.
The
basic
composition
of
the
active
ingredient
consists
of
a
well­
known
carbohydrate
(
rhamnose
sugar)
and
fatty
acid
(
hydroxydecanoic
acid).
The
active
ingredient
is
a
mixture
of
two
types
of
rhamnolipid
molecules,
R1
(
RLL)
and
R2
(
RRLL)
at
a
ratio
of
R2:
R1
=
0.7
­
2.0.
Chemical
name
of
the
rhamnolipid
molecules
is
as
follows:
Molecule
1
(
defined
as
R1
or
RLL):
Decanoic
acid,
3­[(
6­
deoxy­
a­
L­
mannopyranosyl)
oxy]­,
1­(
carboxymethyl)
octyl
ester;
and
molecule
2
(
defined
as
R2
or
RRLL):
Decanoic
acid,
3­[[
6­
deoxy­
2­
O­(
6­
deoxy­
a­
L­
mannopyranosyl)­
a­
Lmannopyranosyl
oxy]­,
1­
(
carboxymethyl)
octyl
ester.
Rhamnolipid
biosurfactant,
in
particular,
causes
the
lysis
of
zoospores
of
plant
pathogens.
Zoospores,
the
unicellular,
motile
spore
stage
in
the
life
cycle
of
plant
pathogens,
are
vulnerable
to
rhamnolipid
biosurfactants
due
to
the
fact
that
the
membrane­
bound
spore
lacks
a
protective
cell
wall.
The
rhamnolipid
destroys
the
permeability
of
the
plasma
membrane
and
results
in
the
loss
of
motility
and
rapid
lysis
of
the
zoospore.
Rhamnolipid
biosurfactants
are
effective
against
all
zoosporic
plant
pathogens,
such
as
downy
mildews,
Pythium
and
Phytophthora.
Biosurfactants
are
produced
by
a
variety
of
microorganisms
and
have
been
shown
to
play
a
role
in
enhancing
bioavailability
and
biodegradation
of
petroleum
hydrocarbons,
in
the
attachment
and
detachment
of
bacteria
to
surfaces,
and
in
complexing
metals
efficiently.
Biosurfactants
have
application
in
cosmetics,
personal
care
products,
detergents,
textile
processing,
agricultural
crop
protection
products,
metal
treatment
and
processing,
leather
processing,
hard
surface
cleaning,
electronics
component
cleaning,
pulp
and
paper
processing,
paint
formulation,
hydrocarbon
recovery,
oil
tank
cleaning
and
oil
sludge
remediation.
Rhamnolipids
are
comprised
of
extracellular
natural
substances
(
glycolipids)
produced
during
a
controlled
aerobic
fermentation
process
utilizing
a
strain
of
the
bacterium
pseudomonas
aeruginosa.
Rhamnolipids
are
recovered
from
the
process
by
centrifugation,
extraction,
and
subsequent
purification.
No
bacteria
are
present
in
the
manufactured
product
and
the
production
processes
are
strict
in
quality
control
to
assure
no
live
organisms
exist.
Purified
rhamnolipids
can
be
quantified
by
weight
and
rhamnose
determination.
2.
A
statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
An
analytical
method
for
residues
is
not
applicable.
It
is
not
expected
that,
when
used
as
proposed,
rhamnolipid
biosurfactant
would
result
in
residues
that
are
of
toxicological
concern.

C.
Mammalian
Toxicological
Profile
Rhamnolipid
biosurfactant
has
been
evaluated
for
toxicity
through
oral,
dermal,
inhalation
and
eye
routes
of
exposure.
Studies
indicate
the
end­
use
product
is
Toxicity
Category
I
for
eye
irritation
(
diluted
end­
use
product
is
Toxicity
Category
IV
for
eye
irritation),
and
Toxicity
Category
IV
for
all
other
routes
of
exposure.
Studies
resulted
in
an
acute
oral
lethal
dose
(
LD50)
>
5,000
milligrams/
kilogram
(
mg/
kg),
acute
dermal
LD50
>
5,000
mg/
kg,
acute
inhalation
lethal
concentration
(
LC50)
2.05
mg/
L,
primary
eye
irritation
severe
at
9.5%
active
ingredient
and
slight
at
1.0%
active
ingredient,
and
primary
skin
irritation
minimal.
A
waiver
has
been
requested
for
dermal
sensitization
based
on
the
fact
that
the
active
ingredient
is
not
toxic
or
irritating
dermally,
and
a
lack
of
reported
effects
by
users
of
the
surfactant
in
a
variety
of
products.
Rhamnolipid
biosurfactants
have
been
marketed
for
over
3
years
as
an
emulsifier,
dispersant
and
wetting
agent.
Since
its
discovery,
no
incidents
of
hypersensitivity
have
been
reported
by
researchers,
manufacturers
or
users.
A
waiver
has
been
requested
for
genotoxicity
based
on
the
fact
that
rhamnolipid
biosurfactant
is
not
related
to
any
known
mutagen
and
does
not
belong
to
a
chemical
class
of
compounds
containing
known
mutagens.
The
rhamnolipid
molecules
are
simply
glycolipids
composed
of
a
rhamnose
sugar
ring
and
a
fatty
acid
tail.
Individually
these
molecules
are
not
considered
toxic
or
mutagenic.
Rhamnose
is
a
comparatively
rare
sugar
listed
by
FDA
as
a
food
additive.
Fatty
acids
are
ubiquitous
in
animals
and
plants,
and
are
the
major
source
of
energy
in
the
body.
Consequently
the
breakdown
products
of
rhamnolipids
are
of
little
toxicological
concern.
A
waiver
has
been
requested
for
90
 
day
oral
toxicity,
teratogenicity
and
immunotoxicity
based
on
the
physical
mode
of
action
of
the
product,
the
demonstrated
lack
of
oral,
dermal
and
inhalation
toxicity,
and
the
innocuous
nature
of
the
potential
breakdown
products
of
rhamnolipid
biosurfactants.
The
mode
of
action
of
rhamnolipid
biosurfactants
is
a
physical
action
on
the
plant
pathogen
rather
than
a
specific
VerDate
Jan<
31>
2003
16:
10
May
08,
2003
Jkt
200001
PO
00000
Frm
00114
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09MYN1.
SGM
09MYN1
25029
Federal
Register
/
Vol.
68,
No.
90
/
Friday,
May
9,
2003
/
Notices
toxic
action.
Rhamnolipid
biosurfactant
is
virtually
non­
toxic
to
rats
as
demonstrated
in
the
acute
oral,
dermal
and
inhalation
studies
submitted.
The
lack
of
mammalian
toxicity
supports
the
position
that
the
physical
action
of
rhamnolipid
biosurfactants
is
a
physical
interaction
with
the
zoospore
membrane
rather
than
a
specific
toxic
mechanism
that
might
be
of
concern.
The
chemical
structures
of
the
rhamnolipids
suggest
that
there
is
little
potential
for
chronic
toxicity,
teratogenicity
or
immunotoxicity
in
animals
or
humans
as
a
result
of
exposure.
The
rhamnolipid
molecules
are
simply
glycolipids
composed
of
a
rhamnose
sugar
ring
and
a
fatty
acid
tail.
Individually
these
molecules
are
not
considered
toxic.

D.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Dietary
exposure
from
use
of
rhamnolipid
biosurfactant,
as
proposed,
is
minimal.
The
use
of
rhamnolipid
biosurfactant
involves
low
levels
of
active
ingredient
applied
to
growing
plants
prior
to
harvest.
Residues
of
rhamnolipid
biosurfactant
are
not
expected
to
be
of
toxicological
concern.
The
rhamnolipid
molecules
are
simply
glycolipids
composed
of
a
rhamnose
sugar
ring
and
a
fatty
acid
tail.
Individually
these
molecules
are
not
considered
toxic.
ii.
Drinking
water.
Similarly,
exposure
to
humans
from
residues
of
rhamnolipid
biosurfactant
in
consumed
drinking
water
would
be
unlikely.
Rhamnolipid
biosurfactant
is
a
naturally
occurring
extra­
cellular
substance
that
is
produced
by
a
microorganism
known
to
exist
in
plant
habitats;
it
is
not
known
to
grow
or
thrive
in
aquatic
environments.
Potential
exposure
to
surface
water
would
be
negligible
and
exposure
to
drinking
water
(
well
or
ground
water)
would
be
impossible
to
measure.
2.
Non­
dietary
exposure.
The
potential
for
non­
dietary
exposure
to
the
general
population,
including
infants
and
children,
is
unlikely
as
the
proposed
use
sites
are
agricultural
settings.
However,
non­
dietary
exposures
would
not
be
expected
to
pose
any
quantifiable
risk
due
to
a
lack
of
residues
of
toxicological
concern.
Personal
protective
equipment
mitigates
the
potential
for
exposure
to
applicators
and
handlers
of
the
proposed
products,
when
used
in
agricultural
settings.

E.
Cumulative
Exposure
It
is
not
expected
that,
when
used
as
proposed,
rhamnolipid
biosurfactant
would
result
in
residues
that
are
of
toxicological
concern.
The
rhamnolipid
molecules
are
simply
glycolipids
composed
of
a
rhamnose
sugar
ring
and
a
fatty
acid
tail.
Individually
these
molecules
are
not
considered
toxic.

F.
Safety
Determination
1.
U.
S.
population.
Acute
toxicity
studies
have
shown
that
rhamnolipid
biosurfactant
is
not
toxic,
but
is
irritating
via
ocular
exposure.
Residues
of
rhamnolipid
biosurfactant
are
not
expected
to
be
of
toxicological
concern.
The
rhamnolipid
molecules
are
simply
glycolipids
composed
of
a
rhamnose
sugar
ring
and
a
fatty
acid
tail.
Individually
these
molecules
are
not
considered
toxic.
There
is
a
reasonable
certainty
of
no
harm
to
the
general
U.
S.
population
from
exposure
to
this
active
ingredient.
2.
Infants
and
children.
As
mentioned
above,
residues
of
rhamnolipid
biosurfactant
are
not
expected
to
be
of
toxicological
concern.
There
is
a
reasonable
certainty
of
no
harm
for
infants
and
children
from
exposure
to
rhamnolipid
biosurfactant
from
the
proposed
uses.

G.
Effects
on
the
Immune
and
Endocrine
Systems
To
date
there
is
no
evidence
to
suggest
that
rhamnolipid
biosurfactant
functions
in
a
manner
similar
to
any
known
hormone,
or
that
it
acts
as
an
endocrine
disrupter.

H.
Existing
Tolerances
There
is
no
U.
S.
EPA
tolerance
for
rhamnolipid
biosurfactant.

I.
International
Tolerances
A
Codex
Alimentarium
Commission
Maximum
Residue
Level
is
not
required
for
rhamnolipid
biosurfactant.
[
FR
Doc.
03
 
11478
Filed
5
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7496
 
7]

Office
of
Environmental
Information
Draft
Data
Standard
for
Exchanging
Permitting
Information
and
Draft
Data
Standard
for
Federal
Facility
Identification
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
information
availability
and
request
for
comments.

SUMMARY:
Notice
of
availability
is
hereby
given
for
a
45­
day
public
comment
period
for
the
draft
data
standards:
Draft
Data
Standard
for
Permitting
Information;
and
the
Draft
Federal
Facility
Identification
Data
Standard.
These
draft
standards
consist
of
a
list
of
data
elements,
definitions
for
these
elements,
formats,
notes,
and
explanatory
preamble
language.
The
draft
standards
were
developed
through
the
partnership
efforts
of
States,
tribes,
and
the
U.
S.
Environmental
Protection
Agency
participating
in
the
Environmental
Data
Standards
Council
(
EDSC).
The
EDSC
convened
one
Action
Team
to
develop
a
more
comprehensive
set
of
data
elements
to
facilitate
the
sharing
permit
related
information.
The
EDSC
also
formed
an
Action
Team
whose
purpose
was
to
reach
consensus
on
standardized
means
of
identifying
facilities
that
are
owned
or
operated,
or
were
owned
or
operated,
by
the
Federal
government.
The
EPA
and
the
EDSC
invite
comment
on
these
standards
from
States,
EPA,
tribes,
database
managers
in
the
public
and
private
sectors,
and
the
general
public
with
interest
in
exchanging
information
concerning
environmental
permits
and
Federal
facilities.

DATES:
Comments
must
be
submitted
on
or
before
June
23,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
by
facsimile,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
1.
A.
of
the
SUPPLEMENTARY
INFORMATION
section.

FOR
FURTHER
INFORMATION
CONTACT:
Draft
Data
Standard
for
Permitting
Information,
Tim
Crawford,
Office
of
Environmental
Information,
Office
of
Information
Collection,
MC
 
2822T,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington
DC
20460;
Telephone
(
202)
566
 
1652.
Draft
Federal
Facility
Identification
Data
Standard,
John
Harman,
Office
of
Environmental
Information,
Office
of
Information
Collection,
MC
 
2822T,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington
DC
20460;
Telephone
(
202)
566
0748.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
How
Can
I
Get
Copies
of
These
Draft
Standards
and
Other
Related
Information
?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
Docket
ID
No.
OEI
 
2003
 
0028.
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
VerDate
Jan<
31>
2003
16:
10
May
08,
2003
Jkt
200001
PO
00000
Frm
00115
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09MYN1.
SGM
09MYN1