Document ID: EPA-HQ-OPP-2003-0020-0001
Agency: epa
Document Type: Notice
Title: Aspergillus flavus AF36; Notice of Filing a Pesticide Petition to Establish an Exemption from a               Tolerance for a Certain Pesticide Microbial Agent in or on Food
Posted Date: 2003-02-14T05:00Z

7554
Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
13.35%
of
the
acute
reference
dose.
The
actual
exposures
are
likely
to
be
much
less
as
more
realistic
data
and
models
are
developed.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD
(
acute
or
chronic),
because
the
RfD
represents
the
level
at
or
below
which
exposure
will
not
pose
appreciable
risk
to
human
health.
DWLOC
for
adults
both
acute
(
9,860
ppb)
and
chronic
(
5,936
ppb)
are
several
orders
of
magnitude
above
the
conservative
DWEC
for
acute
(
122
ppb)
and
chronic
(
37
ppb)
worst
case
scenarios.
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
occur
to
the
U.
S.
population
from
aggregate
exposure
(
food
and
drinking
water)
to
residues
of
pyrimethanil.
2.
Infants
and
children.
The
relevant
toxicity
studies
as
discussed
in
the
toxicology
section
above
show
no
extra
sensitivity
of
infants
and
children
to
pyrimethanil,
therefore,
the
FQPA
safety
factor
can
be
removed.
Using
the
assumptions
and
data
described
in
the
exposure
section
above,
it
is
concluded
that
dietary
risk
from
the
proposed
uses
of
pyrimethanil
are
acceptable
for
all
infant
and
children
sub­
populations
examined.
The
most
highly
exposed
sub­
population
was
non­
nursing
infants
for
both
the
chronic
and
acute
analyses.
The
sub­
population
non­
nursing
infants
utilizes
0.9%
(
0.001563
mg/
kg
bw/
day)
of
the
chronic
reference
dose
and
13.35%
(
0.040040
mg/
kg
bw/
day)
of
the
acute
reference
dose.
All
other
infant
and
children
populations
have
less
exposure.
The
chronic
and
acute
drinking
water
levels
of
concern
for
children
(
1,684
ppb
and
2,600
ppb
respectively)
are
well
above
the
conservative
drinking
water
estimated
concentrations
for
chronic
and
acute
scenarios.
The
chronic
DWEC
is
37
ppb
and
the
acute
DWEC
is
122
ppb.
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
occur
to
infants
and
children
from
aggregate
exposure
to
residues
of
pyrimethanil.

F.
International
Tolerances
Maximum
Residue
Limits
for
pyrimethanil
have
not
been
established
by
the
Codex
Alimentarius
Commission.
[
FR
Doc.
03
 
3695
Filed
2
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0020;
FRL
 
7289
 
9]

Aspergillus
flavus
AF36;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
an
Exemption
from
a
Tolerance
for
a
Certain
Pesticide
Microbial
Agent
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
microbial
agent
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0020,
must
be
received
on
or
before
March
17,
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:
Shanaz
Bacchus,
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
 
8097;
e­
mail
address:
bacchus.
shanaz@
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
categories
and
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions.
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
 
0020.
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
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14,
2003
/
Notices
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
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
 
0020.
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
 
0020.
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
 
0020.
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
 
0020.
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.

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14,
2003
/
Notices
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
record
keeping
requirements.

Dated:
February
6,
2003.
Phil
Hutton,
Acting
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.

Interregional
Research
Project
Number
4
and
The
Arizona
Cotton
Research
and
Protection
Council
PP
8E5001
EPA
has
received
a
pesticide
petition
(
PP
8E5001)
from
Interregional
Research
Project
Number
4
(
IR
 
4),
New
Jersey
Agricultural
Experiment
Station,
Technology
Center,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
on
behalf
of
the
Arizona
Cotton
Research
and
Protection
Council,
3721
East
Wier
Avenue
Phoenix,
Arizona
85040
 
2933
proposing
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.1206
by
establishing
an
amendment/
expansion
of
an
existing
tolerance
exemption
for
the
microbial
pesticide
Aspergillus
flavus
AF36
in
or
on
the
food
and
feed
commodity
cotton
and
its
by
products.
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
the
aforesaid
Interregional
Research
Project
Number
4
(
IR
 
4),
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
the
pesticide
petition
on
behalf
of
the
Arizona
Cotton
Research
and
Protection
Council,
however
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
Aspergillus
flavus
AF36,
a
nonaflatoxin
producing
strain
of
Aspergillus
flavus,
is
proposed
for
application
to
cotton
to
reduce
the
incidence
of
aflatoxin
producing
strains
ofAspergillus
flavus
and
thereby
reduce
aflatoxin
contamination
of
cottonseed.
When
applied
just
prior
to
flowering,
Aspergillus
flavus
AF36
which
does
not
produce
aflatoxin,
competitively
excludes
aflatoxin
producing
Aspergillus
flavus
strains
without
increasing
Aspergillus
flavus
in
the
environment
in
the
long
term.
Sterile
wheat
seed
colonized
with
Aspergillus
flavus
AF36
is
applied
at
10
lb
of
enduse
product
(
total
amount
of
active
ingredient
less
than
0.01
lb/
acre)
per
acre.
The
pesticide
is
currently
being
used
in
certain
counties
in
the
States
of
Arizona
and
Texas
under
an
Experimental
Use
Permit
(
EPA
Reg.
No.
69224
 
EUP
 
1).
The
current
submission
proposes
to
establish
a
permanent
exemption
from
tolerance
for
residues
of
Aspergillus
flavus
AF36
on
cotton
and
its
byproducts.

B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
The
pesticide
and
corresponding
residues
are
identified
as
Aspergillus
flavus
AF36,
a
non­
aflatoxin­
producing
strain
of
Aspergillus
flavus.
2.
Magnitude
of
residue
at
the
time
of
harvest
and
method
used
to
determine
the
residue.
Aspergillus
flavus
AF36
is
a
naturally
occurring
fungus
isolated
from
cottonseed
produced
in
the
Yuma
Valley
of
Arizona.
Aspergillus
flavus
AF36
has
been
shown
to
be
naturally
and
consistently
associated
with
commercial
cotton
grown
in
Arizona.
Other
than
immediately
after
application,
the
overall
quantity
of
Aspergillus
flavus
at
time
of
harvest
on
cottonseed
grown
in
fields
where
Aspergillus
flavus
AF36
has
been
applied
and
has
been
shown
to
be
similar
to
levels
on
cottonseed
grown
in
fields
where
no
application
was
made.
Aspergillus
flavus
is
a
widespread
fungus.
It
is
particularly
well
adapted
to
the
hot
desert
regions
of
Arizona
where
it
is
widespread
in
the
environment.
The
communities
of
Aspergillus
flavus
in
the
desert
and
in
agricultural
fields
are
naturally
composed
of
both
aflatoxin
producing
(
toxigenic)
and
aflatoxin
nonproducing
(
atoxigenic)
strains.
Both
atoxigenic
and
toxigenic
strains
have
been
found
on
essentially
all
plant
material
and
soils
in
the
desert
valleys
of
Arizona.
The
goal
of
applications
is
to
increase
the
percent
of
the
Aspergillus
flavus
community
composed
of
the
atoxigenic
strain
AF36
and
to
decrease
the
percent
of
Aspergillus
flavus
that
produces
aflatoxins
on
the
crop
and
in
the
fields.
3.
A
statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
An
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
microbial
pesticide
Aspergillus
flavus
AF36
in/
on
cotton
is
being
proposed
for
cotton
treated
in
Arizona
and
Texas.
Aspergillus
flavus
isolate
AF36,
when
applied
to
the
soil
just
prior
to
bloom
has
been
shown
to
significantly
reduce
the
levels
of
aflatoxin
in
cottonseed
at
harvest.
Aflatoxin
levels
in
cottonseed
products
are
regulated
by
the
Food
and
Drug
Administration
(
FDA).
FDA
does
not
allow
cottonseed
products
containing
aflatoxin
at
20
parts
per
billion
(
ppb),
or
higher
to
be
used
in
dairy
rations.
FDA
regulations
also
do
not
allow
cottonseed
products
containing
aflatoxin
above
300
ppb,
to
be
used
for
feeding
beef
cattle.
All
lots
of
the
active
ingredient
(
Aspergillus
flavus
isolate
AF36)
and
the
formulated
products
are
monitored
for
aflatoxin
production
as
part
of
a
rigorous
quality
control
program.
Starter
cultures
of
Aspergillus
flavus
isolate
AF36
used
in
the
production
of
the
enduse
product
are
always
screened
for
strain
identity
by
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/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
compatibility,
and
for
aflatoxin
production
using
thin
layer
chromatography
and
appropriate
standards.
Quality
control
standards
are
zero
tolerance
in
the
starter
cultures
and
in
the
formulated
product
for
aflatoxin
production,
and
for
Aspergillus
flavus
not
identified
as
Aspergillus
flavus
isolate
AF36.
Aspergillus
flavus
AF36
has
never
been
found
to
produce
aflatoxin.

C.
Mammalian
Toxicological
Profile
An
acute
oral
toxicity
test
was
performed
whereby
a
single
oral
dose
of
5,000
milligrams/
kilogram
body
weight
(
mg/
kg/
bwt)
per
animal
of
Aspergillus
flavus
AF36
colonized
wheat
seed
was
administered
by
gavage
to
five
male
and
five
female
Sprague
Dawley
rats.
The
oral
LD50
of
Aspergillus
flavus
AF36
was
determined
to
be
greater
than
5,000
mg/
kg
rat
body
weight.
No
clinical
signs
were
observed
during
the
14
 
day
study
and
no
abnormalities
or
adverse
effects
were
observed
in
any
of
the
rats
upon
necropsy.
An
initial
pulmonary
rat
study
resulted
in
lethality
in
a
significant
number
of
animals
treated
with
either
the
live
Aspergillus
flavus
AF36
in
Tween
80
or
heat
killed
Aspergillus
flavus
AF36
in
Tween
80.
Onset
of
symptoms
was
rapid
after
dosing
with
all
deaths
occurring
by
day
4
of
the
study.
All
rats
surviving
to
day
4
of
the
study
recovered
and
all
rats
sacrificed
(
as
scheduled)
on
day
8
or
day
15
of
the
study
had
totally
eliminated
viable
Aspergillus
flavus
AF36
from
the
lungs,
caecal
contents,
and
feces.
There
was
no
evidence
of
infectivity.
The
aetiology
of
deaths
was
unclear.
It
appeared
that
Aspergillus
flavus
AF36
prepared
as
a
test
substance
with
Tween
80
caused
a
severe
acute
inflammatory
response.
Retrospective
literature
review
and
consultation
with
a
toxicologist
supported
the
theory
that
the
responses
were
a
result
of
a
synergism
with
Tween
80
and/
or
of
Tween
80
breakdown
products
formed
during
preparation
of
the
spore
suspension
test
substance.
A
second
rat
pulmonary
study
was
therefore
undertaken.
In
the
second
study
the
conidia
were
both
washed
from
the
wheat
and
suspended
in
sterile
physiological
saline
instead
of
Tween
80.
Animals
(
2
male
and
2
female
for
each
treatment
level)
were
dosed
at
0,
105,
106,
107,
and
108
colony
forming
units
per
rat.
There
were
no
clinical
signs
in
any
of
the
treatment
groups
considered
to
be
associated
with
the
test
substance.
Rats
were
sacrificed
at
day
8
without
treatment
associated
mortality.
No
abnormalities
were
observed
in
any
of
the
animals
at
the
macroscopic
examination
at
termination.
Based
on
these
two
mammalian
studies,
the
petitioner
concludes
that
Aspergillus
flavus
AF36
does
not
present
either
a
toxicological
or
an
infectious
risk
to
mammals.
Data
waivers
were
requested
for
the
following
toxicology
studies:
Acute
dermal
toxicology/
pathology,
primary
dermal
irritation,
primary
eye
irritation,
and
acute
intraperitoneal
toxicology/
pathology
effects
of
the
microbial
pesticide.
The
following
rationales
were
used
as
a
basis
for
the
data
waiver
requests:
 
Researchers
and
other
workers
have
worked
with
Aspergillus
flavus
AF36
at
the
Southern
Regional
Research
Center
for
over
10
years
and
in
commercial
fields
(
1996
to
1998)
and
in
hand­
picked
field
plots
(
1989
to
1994)
without
report
of
any
adverse
health
effects.
 
Aspergillus
flavus
AF36
is
widely
distributed
in
the
environment
and
its
occurrence
is
natural.
 
The
label
will
require
applicators
and
other
handlers
to
wear
Personal
Protective
Equipment
(
PPE)
such
as
waterproof
gloves,
a
dust/
mist
filtering
respirator
with
the
appropriate
NIOSH
approval
prefix
N
 
95,
P
 
95,
or
R
 
95,
coveralls,
long
sleeved
shirt
and
long
pants,
and
shoes
plus
socks,
and
goggles,
to
mitigate
against
dermal
and
primary
eye
irritation
exposure.
The
pesticide
is
to
be
applied
aerially
by
mixers/
handlers
and
applicators
who
are
licensed
and
trained
to
handle
restricted
materials.
At
the
10
lb/
acre
application
rate
of
the
formulated
material,
the
total
amount
of
active
ingredient
is
less
than
0.01
lb/
acre.
Applications
of
AF36
do
not
significantly
impact
the
total
amount
of
Aspergillus
flavus
in
the
soil
or
crop,
but
only
change
the
proportion
of
the
AF36
strain
in
relation
to
the
overall
soil
population.
Since
the
product
is
applied
to
cotton
fields
as
a
granular
formulation
on
colonized
wheat
seeds,
exposure
from
drift
is
minimal.
In
addition,
the
following
rationales
were
advanced
in
support
of
the
data
waiver
requests
for
acute
dermal
toxicity
and
primary
dermal
irritation.
These
studies
were
waived
during
the
experimental
use
program,
based
upon
the
lack
of
toxicity
in
animals
dosed
orally.
While
other
Aspergillus
flavus
strains
have
been
reported
to
be
dermal
sensitizers,
this
testing
is
not
warranted,
since
the
aerial
method
of
application
and
the
PPE
required
on
the
label
will
mitigate
dermal
exposure
to
workers
and
pesticide
handlers.
The
acute
intraperitoneal
study
was
waived
based
upon
the
lack
of
toxicity
in
animals
dosed
orally
and
by
pulmonary/
intratracheal
instillation.
Genotoxicity,
reproductive
and
developmental
toxicity,
subchronic
toxicity
and
chronic
toxicity
testing
were
not
performed,
since
no
adverse
effects
were
observed
in
the
acute
toxicology
study
Tier
1
studies.
Tier
II
(
885.3550),
subchronic
toxicology
study
(
EPA
OPPTS
885.3600)
and
chronic
feeding
studies
(
guideline
152
 
50)
are
only
required
if
triggered
by
adverse
effects
observed
in
Tier
I
studies.

D.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Aspergillus
flavus
AF36
is
a
naturally
occurring
organism,
which
does
not
produce
aflatoxin
and
is
thus
safer
than
the
aflatoxin­
producing
Aspergillus
flavus
isolates.
Proposed
uses
and
application
rates
will
not
result
in
increases
in
the
total
population
of
Aspergillus
flavus
on
the
mature
crop
beyond
naturally
occurring
background
levels.
FDA
does
not
allow
cottonseed
products
containing
aflatoxin
at
20
ppb
or
higher
to
be
used
in
dairy
rations.
FDA
regulations
also
do
not
allow
cottonseed
products
containing
aflatoxin
levels
above
300
ppb,
to
be
used
for
feeding
beef
cattle.
Aspergillus
flavus
AF36,
when
applied
to
the
soil
just
prior
to
bloom,
has
been
shown
to
significantly
reduce
the
levels
of
aflatoxin
in
cottonseed
at
harvest.
Furthermore,
the
proposed
use
and
application
rate
will
not
increase
exposure
of
humans
to
Aspergillus
flavus
by
dietary
means,
since
cotton
itself
is
not
a
food
product
for
human
consumption.
There
is
minimal
dietary
exposure
to
Aspergillus
flavus
from
cottonseed.
There
is
no
mechanism
for
Aspergillus
flavus
to
be
transferred
from
the
seed
to
animal
products
and
there
is
no
evidence
that
the
fungus
readily
contaminates
meat
or
milk.
Seed
is
typically
extracted
for
oil
with
hexane
and
that
process
kills
the
fungus.
Furthermore,
applications
of
Aspergillus
flavus
AF36
do
not
increase
the
indigenous
populations
of
Aspergillus
flavus
associated
with
the
harvested
crop.
The
applications
merely
alter
the
composition
of
the
fungal
community
associated
with
the
mature
crop
so
that
aflatoxin
producing
strains
are
far
less
frequent.
The
result
is
a
much
lower
incidence
of
aflatoxins
in
the
crop
and
in
the
environment
associated
with
the
developing
and
mature
crop.
ii.
Drinking
water.
Aspergillus
flavus
AF36
is
a
naturally
occurring
organism
that
is
already
widespread
in
the
environment
and
is
not
considered
to
be
a
risk
to
drinking
water.
Both
percolation
through
soil
and
municipal
treatment
of
drinking
water
would
reduce
the
possibility
of
exposure
of
Aspergillus
flavus
through
the
drinking
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7558
Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
water.
Applications
of
Aspergillus
flavus
AF36
do
not
increase
the
longterm
populations
of
Aspergillus
flavus
in
the
environment,
and
thus
are
not
expected
to
influence
the
relationship
of
Aspergillus
flavus
to
water
sources.
Applications
merely
change
the
composition
of
the
Aspergillus
flavus
community
so
that
aflatoxin
producing
strains
are
less
common
in
the
environment.
2.
Non­
dietary
exposure.
The
potential
for
non­
occupational,
non­
dietary
exposure
to
the
general
population
is
not
expected
to
be
significant
and
is
not
expected
to
present
any
risk
of
adverse
health
effects.

E.
Cumulative
Exposure
There
are
no
other
registered
products
containing
Aspergillus
flavus
AF36
or
any
other
isolates
(
strains)
of
the
microbial
active
ingredient.
Data
submitted
show
that
the
fungal
metabolite
of
concern,
which
is
aflatoxin,
is
not
produced
by
Aspergillus
flavus
AF36
in
the
crop
or
in
artificial
media
in
the
lab.
When
applied
prior
to
flowering,
Aspergillus
flavus
AF36
has
been
shown
to
exclude
aflatoxin
producing
fungi
competitively
from
the
developing
crop
and
to
reduce
aflatoxin
contamination
of
cottonseed.
Data
show
that
the
proposed
use
will
not
result
in
appreciable
increases
in
the
long­
term
population
of
Aspergillus
flavus
on
the
crop
beyond
naturally
occurring
levels.
Furthermore,
there
is
no
expectation
of
cumulative
effects
with
other
pesticides.

F.
Safety
Determination
1.
U.
S.
population.
Aspergillus
flavus
AF36
is
a
naturally
occurring
organism.
This
isolate
has
low
toxicity
as
demonstrated
by
the
acute
oral
toxicity
study
in
rats.
Aspergillus
flavus
is
ubiquitous
throughout
the
hot
desert
valleys
in
Arizona.
Studies
have
shown
that
treatment
of
cotton
fields
just
prior
to
flowering
with
sterile
wheat
seed
colonized
by
Aspergillus
flavus
AF36
at
10
lb
per
acre
does
not
increase
the
long­
term
populations
of
Aspergillus
flavus
either
on
the
crop
at
maturity
or
in
the
soil
1
year
after
application.
Based
on
this
information,
Interregional
Research
Project
Number
 
4
is
of
the
opinion
that
the
aggregate
exposure
to
Aspergillus
flavus
over
a
lifetime
should
not
change
with
application
of
Aspergillus
flavus
AF36,
and
exposure
to
both
aflatoxin
producing
Aspergillus
flavus
strains
and
aflatoxin
should
decrease.
This
should
be
beneficial
to
human
health.
Thus,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
Aspergillus
flavus
AF36.
2.
Infants
and
children.
Based
on
the
lack
of
toxicity
and
natural
occurrence,
there
is
reasonable
certainty
that
no
harm
to
infants,
children,
or
adults
will
result
from
aggregate
exposure
to
Aspergillus
flavus
AF36.
Exempting
Aspergillus
flavus
AF36
from
the
requirement
of
a
tolerance
should
pose
no
significant
risk
to
humans
or
the
environment.

G.
Effects
on
the
Immune
and
Endocrine
Systems
Aspergillus
flavus
AF36
is
a
naturally
occurring
organism,
which
does
not
produce
aflatoxin,
and
is
thus
safer
than
the
Aspergillus
flavus
isolates
that
produce
aflatoxin.
To
date
there
is
no
evidence
to
suggest
that
Aspergillus
flavus
AF36
functions
in
a
manner
similar
to
any
known
hormone,
or
that
it
acts
as
an
endocrine
disrupter.

H.
Efficacy
Existence
of
aflatoxins
in
the
environment
is
a
public
health
hazard.
Data
were
submitted
to
demonstrate
that
proper
use
of
Aspergillus
flavus
AF36
results
in
reductions
in
the
average
aflatoxin
producing
potential
of
fungi
resident
in
treated
areas
and
in
reductions
in
the
quantity
of
aflatoxins
in
crops.
In
field
tests
prior
to
1996,
the
aflatoxin
content
of
cottonseed
was
shown
to
be
inversely
related
to
the
proportion
of
the
Aspergillus
flavus
community
on
the
crop
composed
of
Aspergillus
flavus
AF36.
Detailed
analyses
of
the
aflatoxin
content
of
commercial
fields
from
1996
through
1998
confirmed
that
reduced
aflatoxin
levels
were
associated
with
displacement
of
aflatoxin
producers
by
Aspergillus
flavus
AF36
from
treated
crops
and
that
treatments
were
associated
with
up
to
90%
reductions
in
crop
aflatoxin
content.
Efficacy
of
applications
of
Aspergillus
flavus
AF36
in
displacing
aflatoxin
producers
was
demonstrated
for
fungal
communities
both
on
cottonseed
from
treated
crops
at
harvest
and
in
soils
of
treated
fields
1
year
after
treatment.
This
included
cotton
crops
treated
in
1996
(
112
acres
treated),
1997
(
463
acres
treated),
1998
(
499
acres),
1999
(
10,488
acres),
2000
(
16,725
acres),
and
2001
(
19,975
acres
treated).
The
proportion
of
Aspergillus
flavus
communities
composed
of
Aspergillus
flavus
AF36
indicates
the
extent
to
which
aflatoxin
producers
were
displaced.
In
1996
average
incidence
of
AF36
on
treated
crops
was
88.5%
and
in
the
soil,
1
year
after
treatment,
incidence
of
AF36
was
85.2%.
Incidences
of
AF36
on
treated
crops
were
78%
and
67%
in
1997
and
1998,
respectively,
and
in
soil
1
year
after
treatment,
AF36
incidences
were
72%
and
77%,
respectively.
Successful
displacement
was
also
observed
as
the
acreage
treated
rapidly
expanded
from
1999
to
2001
with
average
incidences
of
AF36
on
treated
crops
ranging
from
57%
in
1999
to
66%
in
2001.
Aflatoxin­
producing
S
strain
isolates
of
Aspergillus
flavus
are
prominent
in
soils
of
cotton
producing
areas
of
Arizona
and
south
Texas.
They
produce
more
aflatoxins
than
other
Aspergillus
flavus
isolates
such
as
the
non­
aflatoxinproducing
L
strain
Aspergillus
flavus
AF36.
Applications
of
AF36
during
the
experimental
program
were
effective
at
displacing
the
high
aflatoxin
producing
S
strain
of
Aspergillus
flavus.
During
the
course
of
the
experimental
use
program,
Aspergillus
flavus
AF36
also
caused
long­
term
reductions
in
the
aflatoxin
producing
potential
of
fungal
communities
in
agricultural
fields.
Aspergillus
flavus
AF36
retained
atoxigenicity
(
failure
to
produce
aflatoxins)
upon
repeated
reisolation
from
treated
fields
1,
2,
or
3
years
after
treatment.
Thus,
there
was
a
long­
term
reduction
in
the
potential
of
fungal
communities
to
produce
aflatoxins
in
treated
areas.
The
average
aflatoxin
producing
potential
of
Aspergillus
flavus
communities
resident
in
soils
of
treated
fields
was
reduced
on
average
73%
1
year
after
treatment
over
the
3
year
period
(
1996
to
1999).
S
strain
isolates,
which
produced
very
high
levels
of
aflatoxins,
with
field
averages
ranging
from
7,100
ppb,
aflatoxin
to
22,700
ppb,
aflatoxin,
were
effectively
displaced.
Their
incidence
was
reduced
from
initially
composing
46%
of
Aspergillus
flavus
soil
communities
to
composing
on
average
of
11%.

I.
Existing
Tolerances
The
registrant
is
not
aware
of
any
existing
tolerances
or
tolerance
exemptions
for
Aspergillus
flavus
AF36,
other
than
the
temporary
tolerance
exemption
on
cotton
(
40
CFR
180.1206)
in
conjunction
with
an
EUP,
which
expires
on
December
30,
2004.

J.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
for
residues
of
Aspergillus
flavus
AF36.
Aspergillus
flavus
AF36
containing
products
are
presently
not
registered
for
pest
control
outside
of
the
United
States.

[
FR
Doc.
03
 
3696
Filed
2
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
VerDate
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31>
2003
19:
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