Document ID: EPA-HQ-OPP-2003-0138-0001
Agency: epa
Document Type: Rule
Title: Aspergillus flavus AF36; Exemption from the Requirement of a Tolerance
Posted Date: 2003-07-14T04:00Z

41535
Federal
Register
/
Vol.
68,
No.
134
/
Monday,
July
14,
2003
/
Rules
and
Regulations
§
1.20
Post
issuance
fees.

*
*
*
*
*
(
e)
For
maintaining
an
original
or
reissue
patent,
except
a
design
or
plant
patent,
based
on
an
application
filed
on
or
after
December
12,
1980,
in
force
beyond
four
years;
the
fee
is
due
by
three
years
and
six
months
after
the
original
grant:
By
a
small
entity
(
§
1.27(
a))
......
$
455.00
By
other
than
a
small
entity
.....
$
910.00
(
f)
For
maintaining
an
original
or
reissue
patent,
except
a
design
or
plant
patent,
based
on
an
application
filed
on
or
after
December
12,
1980,
in
force
beyond
eight
years;
the
fee
is
due
by
seven
years
and
six
months
after
the
original
grant:
By
a
small
entity
(
§
1.27(
a))
......
$
1,045.00
By
other
than
a
small
entity
.....
$
2,090.00
(
g)
For
maintaining
an
original
or
reissue
patent,
except
a
design
or
plant
patent,
based
on
an
application
filed
on
or
after
December
12,
1980,
in
force
beyond
twelve
years;
the
fee
is
due
by
eleven
years
and
six
months
after
the
original
grant:
By
a
small
entity
(
§
1.27(
a))
......
$
1,610.00
By
other
than
a
small
entity
.....
$
3,220.00
*
*
*
*
*


6.
Section
1.492
is
amended
by
revising
paragraphs
(
a)(
1)
through
(
a)(
3),
(
a)(
5),
(
b),
and
(
d)
to
read
as
follows:

§
1.492
National
stage
fees.

*
*
*
*
*
(
a)
The
basic
national
fee:
(
1)
Where
an
international
preliminary
examination
fee
as
set
forth
in
§
1.482
has
been
paid
on
the
international
application
to
the
United
States
Patent
and
Trademark
Office:
By
a
small
entity
(
§
1.27(
a))
......
$
365.00
By
other
than
a
small
entity
.....
$
730.00
(
2)
Where
no
international
preliminary
examination
fee
as
set
forth
in
§
1.482
has
been
paid
to
the
United
States
Patent
and
Trademark
Office,
but
an
international
search
fee
as
set
forth
in
§
1.445(
a)(
2)
has
been
paid
on
the
international
application
to
the
United
States
Patent
and
Trademark
Office
as
an
International
Searching
Authority:
By
a
small
entity
(
§
1.27(
a))
......
$
385.00
By
other
than
a
small
entity
.....
$
770.00
(
3)
Where
no
international
preliminary
examination
fee
as
set
forth
in
§
1.482
has
been
paid
and
no
international
search
fee
as
set
forth
in
§
1.445(
a)(
2)
has
been
paid
on
the
international
application
to
the
United
States
Patent
and
Trademark
Office:
By
a
small
entity
(
§
1.27(
a))
......
$
540.00
By
other
than
a
small
entity
.....
$
1,080.00
(
4)
*
*
*
(
5)
Where
a
search
report
on
the
international
application
has
been
prepared
by
the
European
Patent
Office
or
the
Japan
Patent
Office:
By
a
small
entity
(
§
1.27(
a))
......
$
460.00
By
other
than
a
small
entity
.....
$
920.00
(
b)
In
addition
to
the
basic
national
fee,
for
filing
or
later
presentation
of
each
independent
claim
in
excess
of
3:
By
a
small
entity
(
§
1.27(
a))
......
$
43.00
By
other
than
a
small
entity
.....
$
86.00
*
*
*
*
*
(
d)
In
addition
to
the
basic
national
fee,
if
the
application
contains,
or
is
amended
to
contain,
a
multiple
dependent
claim(
s),
per
application:
By
a
small
entity
(
§
1.27(
a))
......
$
145.00
By
other
than
a
small
entity
.....
$
290.00
*
*
*
*
*

Dated:
July
7,
2003.
James
Rogan,
Under
Secretary
of
Commerce
for
Intellectual
Property
and
Director
of
the
United
States
Patent
and
Trademark
Office.
[
FR
Doc.
03
 
17652
Filed
7
 
11
 
03;
8:
45
am]

BILLING
CODE
3510
 
16
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0138;
FRL
 
7311
 
6]

Aspergillus
flavus
AF36;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
microbial
antifungal
agent
Aspergillus
flavus
AF36,
a
non­
aflatoxin­
producing
member
of
the
naturally­
occurring
genus
of
fungi
Aspergillus,
in
or
on
the
food/
feed
commodity
cotton,
when
the
pesticide
is
used
according
to
its
label
instructions
as
a
prebloom
application.
The
Interregional
Research
Project
Number
4
(
IR­
4),
on
behalf
of
the
Arizona
Cotton
Research
and
Protection
Council,
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Aspergillus
flavus
AF36
in
or
on
cotton
and
its
food/
feed
commodities.
DATES:
This
regulation
is
effective
July
14,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0138,
must
be
received
on
or
before
September
12,
2003.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
IX.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Shanaz
Bacchus,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
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
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
 
0138.
The
official
public
docket
is
intended
to
serve
as
a
repository
for
materials
(
i.
e.,
documents
and
other
information)
submitted
to
the
Agency
in
connection
with
this
action
and/
or
relied
upon
by
the
Agency
in
VerDate
Jan<
31>
2003
14:
49
Jul
11,
2003
Jkt
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PO
00000
Frm
00017
Fmt
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FM\
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41536
Federal
Register
/
Vol.
68,
No.
134
/
Monday,
July
14,
2003
/
Rules
and
Regulations
taking
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
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.
To
the
extent
that
a
particular
document
is
not
located
in
the
official
public
docket,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
The
legacy
docket
for
this
case
is
OPP
 
2003
 
0020,
which
was
set
up
in
connection
with
the
Notice
of
Filing
of
this
pesticide
petition,
8E5001.
It
contains
the
Federal
Register
Notice
dated
February
14,
2003,
(
68
FR
7554),
which
was
published
to
announce
this
petition,
other
relevant
Federal
Register
documents
associated
with
the
exemption
from
temporary
tolerance
which
preceded
this
permanent
exemption
from
tolerance,
and
comments
received
in
response
to
the
publication
of
this
petition.
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/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
February
14,
2003
(
68
FR
7554)
(
FRL
 
7289
 
9),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
8E5001)
by
Interregional
Research
Project
Number
4
(
IR­
4),
New
Jersey
Agricultural
Experiment
Station,
Technology
Center
of
New
Jersey,
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,
AZ
85040
 
2933.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner,
IR­
4,
on
behalf
of
the
Arizona
Cotton
Research
and
Protection
Council.
In
response
to
the
notice
of
filing
of
this
petition,
comments
in
favor
of
the
use
of
the
pesticide
were
received
from
cotton
growers,
processors
and
ginners,
mainly
from
Arizona
and
Texas.
The
petition
requested
that
40
CFR
180.1206
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Aspergillus
flavus
AF36
in
or
on
cotton
and
its
food/
feed
commodities.
Section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
of
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
exemption
is
``
safe.''
Section
408(
c)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
Additionally,
section
408(
b)(
2)(
D)
of
the
FFDCA
requires
that
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.
III.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness,
and
reliability,
and
the
relationship
of
this
information
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
Aspergillus
flavus
AF36
(
also
referred
to
as
AF36)
is
a
non­
aflatoxin­
producing
or
atoxigenic
strain
of
Aspergillus
flavus,
whose
species
are
ubiquitous
around
the
world.
Some
members
of
the
genus
Aspergillus
produce
mycotoxins,
such
as
aflatoxin,
a
potent
carcinogen
produced
by
toxigenic
strains
of
A.
flavus.
Other
members
of
the
genus
Aspergillus
have
been
domesticated
for
commercial
use,
such
as
Aspergillus
niger
for
production
of
enzymes
(
e.
g.,
alpha­
galactosidase
found
in
beano,
a
dietary
supplement)
and
Aspergillus
oryzae
for
production
of
soy
sauce.
The
subject
strain
of
this
final
rule,
Aspergillus
flavus
AF36,
is
characterized
as
an
atoxigenic
strain
by
its
lack
of
production
of
aflatoxin.
It
is
not
vegetatively
compatible
with
the
toxigenic
strains
of
A.
flavus,
a
feature
which
limits
cross­
over
potential
to,
and,
thus,
further
proliferation
of,
the
toxigenic
strains.
Starter
cultures,
selected
on
the
basis
of
the
vegetative
incompatibility
with
aflatoxinproducing
strains,
are
to
be
monitored
by
standard
thin
layer
chromatography
(
TLC)
procedures,
and
visualization
via
scanning
fluorescence
densitometry
scanning
[
Master
Record
Identification
Number
(
MRID)
44626101;
BPPD
Data
Evaluation
Report
of
Analysis
of
Samples,
dated
March
29,
1999
(
hereinafter
referred
to
as
``
BPPD
review
­
March
29,
1999'');
BPPD
Review
of
Supplementary
Information
dated
May
14,
1999
(
hereinafter
referred
to
as
``
BPPD
review
­
May
14,
1999'')].
In
this
manner,
the
applicant
proposes
to
maintain
batches
free
of
aflatoxin
contamination
during
production.
Batches
contaminated
with
aflatoxin,
or
human
pathogens,
or
unintentional
ingredients
above
regulatory
levels
are
to
be
destroyed.
Thus,
use
of
AF36
is
not
likely
to
add
to
the
environmental
burden
of
the
aflatoxin­
producing
strains
of
A.
flavus.
The
pesticide
is
proposed
for
a
single
prebloom
application
once
a
year
to
cotton
fields
to
displace
the
aflatoxinproducing
strains
of
Aspergillus
flavus
from
cotton.
Sterilized
wheat
seeds,
colonized
with
Aspergillus
flavus
AF36,

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/
Rules
and
Regulations
are
to
be
applied
at
10
lb
of
end­
use
product
(
EP)
(
equivalent
to
the
low
rate
of
less
than
0.01
lb
active
ingredient
(
ai)
per
acre).
Within
3
days
of
application
of
the
pesticide,
the
fields
are
furrow
irrigated
to
promote
germination
of
AF36,
which
apparently
colonizes
the
cotton
crop
and
soil,
before
the
aflatoxin­
producing
strains
of
A.
flavus
proliferate.
This
competitive
exclusion
of
the
aflatoxin­
producing
strains
does
not
increase
the
total
Aspergillus
population
in
the
environment
above
background
levels
as
demonstrated
in
soil
and
air
monitoring
studies.
[
MRIDs
45307201,
45307202;
BPPD
Review
of
Soil
and
Air
Monitoring
Studies
and
Product
Performance
Testing
(
Efficacy),
dated
May
15,
2003
(
hereinafter
referred
to
as
``
BPPD
Review
­
May
15,
2003'')].
The
displacement
of
the
toxigenic
strain
of
Aspergillus
flavus
by
AF36
may
reduce
aflatoxin
contamination
of
cotton
seed.
The
toxicology
and
pathogenicity
data
generated
by
the
petitioner
in
support
of
this
tolerance
exemption,
and
reviewed
by
the
Agency,
are
summarized
below.
The
following
discussion
of
the
evaluations
of
the
submitted
studies
and
information
indicates
that
exposure
to
the
pesticide
is
not
likely
to
be
greater
than
that
which
occurs
normally
to
other
ubiquitous
A.
flavus
strains.
Submitted
data
also
indicate
no
toxicity
or
infectivity
of
AF36
in
test
mammalian
systems.
More
detailed
analyses
of
these
studies
can
be
found
in
the
specific
Agency
reviews
of
the
studies
that
are
cited
below.
1.
Acute
oral
toxicity/
pathogenicity
(
OPPTS
Harmonized
Guideline
885.3050;
MRID
43972403).
Agency
evaluation
of
submitted
acute
oral
study
indicates
no
toxicity/
infectivity
effects
of
the
pesticide.
Five
male,
and
five
female
Sprague
Dawley
rats
were
treated
orally
with
the
microbial
pesticide
(
500
milligrams/
milliliter
(
mg/
mL)
or
6.3
x
103
cfu/
mL)
by
gavage.
No
clinical
signs
or
abnormalities
were
noted
during
the
study,
and
the
pesticide
was
considered
to
be
neither
toxic
nor
infective
following
oral
administration
of
a
single
dose.
The
acute
oral
test
resulted
in
a
Toxicity
Category
IV
classification
with
a
lethal
dose
(
LD)
50
greater
than
5,000
milligrams/
kilogram
(
mg/
kg)
body
weight
[
MRID
43972403;
BPPD
Data
Evaluation
Report,
Acute
Oral
Toxicity
Study
in
Rats,
dated
April
23,
1996
(
hereinafter
referred
to
as
``
BPPD
Review
­
April
23,
1996'')].
2.
Acute
pulmonary
toxicity/
pathogenicity
(
OPPTS
Harmonized
Guideline
885.3150;
MRID
45798201).
The
Agency
required
an
intratracheal
pulmonary
infectivity/
pathogenicity
study.
This
test
involves
intratracheal
instillation
of
the
test
material
and
post
mortem
examination
of
lungs
and
other
organs
for
clearance.
Three
studies
were
submitted
in
support
of
the
mammalian
acute
infectivity/
pathogenicity
pulmonary
guideline:
A
range
finding
study
and
two
complete
acute
pulmonary
studies.
The
dose­
range
study
concluded
that
108
cfu/
rat
would
be
a
suitable
test
dose
level
for
the
acute
pulmonary
studies
[
MRID
45739101;
BPPD
Data
Evaluation
Report,
dated
April
02,
2003a
(
hereinafter
referred
to
as
``
BPPD
Review
­
April
02,
2003a'')].
In
the
first
acute
pulmonary
study,
conducted
with
Tween
80
as
a
surfactant
in
the
test
material,
26
male
and
26
female
Sprague
Dawley
rats
(
approximately
8
to
10
weeks
old)
each
were
dosed
with
a
single
intratracheal
dose
of
1.2
mL/
kg
at
5.30
x
108
cfu/
mL
(
or
1.28
to
1.63
x
108
cfu/
animal).
Results
from
this
study
indicated
that
the
test
organism
was
neither
infective
nor
pathogenic,
in
spite
of
rat
mortality,
which
is
believed
to
have
been
due
to
a
severe
acute
inflammatory
response
to
the
Tween
80
[
MRID
45798101;
BPPD
Data
Evaluation
Report,
dated
April
02,
2003a
(
hereinafter
referred
to
as
``
BPPD
Review
­
April
02,
2003b'')].
In
the
second
acute
pulmonary
study,
which
was
a
repetition
of
the
first
acute
pulmonary
test,
but
was
conducted
without
Tween
80,
25
male
and
25
female
Sprague
Dawley
rats
(
approximately
8
to
10
weeks
old)
each
received
a
single
intratracheal
dose
of
approximately
1.2
mL/
kg.
Mortality
of
4
rats
by
day
2
appeared
to
be
attributable
to
an
initial
dosing
effect.
The
rest
of
the
test
animals
showed
an
initial
response,
followed
by
a
rapid
recovery
indicating
no
toxicity.
Although
some
surviving
rats
lost
weight
intermittently,
all
surviving
rats
gained
weight
prior
to
scheduled
sacrifice.
No
clinical
signs
that
were
considered
to
be
due
to
the
test
organism
were
observed
in
the
test
rats.
Organs
were
examined
post
mortem
as
previously
described.
Aspergillus
flavus
AF36
was
detected
in
the
lungs
with
clearance
by
day
8
after
dosing.
No
test
organisms
were
detected
in
any
samples
from
the
shelf
control
or
inactivated
test
organism
treated
rats.
Based
on
the
presented/
submitted
data,
including
the
clearance
data,
the
test
organism,
Aspergillus
flavus
AF36,
was
considered
not
toxic,
infective,
or
pathogenic
to
the
rat
pulmonary
system.
The
study
is
acceptable.
3.
Acute
inhalation
(
OPPTS
Harmonized
Guideline
152
 
32).
The
inert
is
sterilized
wheat
seeds,
comprising
approximately
99%
of
this
pesticidal
product.
It
acts
as
a
matrix
and
nutrient
source
for
the
germinating
AF36.
Because
this
constitutes
the
majority
of
the
pesticide
and
does
not
contain
respirable
particles
of
less
than
10
microns,
an
inhalation
study
was
not
required
pursuant
to
40
CFR
158.740(
c).
In
addition,
based
on
the
results
obtained
through
the
acute
pulmonary
toxicity/
pathogenicity
studies
summarized
immediately
above,
AF36
is
considered
not
toxic,
infective,
or
pathogenic
to
the
rat
pulmonary
system.
On
the
basis
of
this
study
and
the
nature
of
the
inert
ingredients
present,
the
pesticide
was
considered
Toxicity
Category
III
for
acute
inhalation
effects.
[
MRID
45798201;
BPPD
Data
Evaluation
Report,
dated
April
02,
2003c
(
hereinafter
referred
to
as
``
BPPD
Review
­
April
02,
2003c'')].
4.
Hypersensitivity
incidents
(
OPPTS
Harmonized
Guideline
152
 
37;
MRID
45739104).
The
registrant
submitted
information
(
MRID
45739104)
to
demonstrate
the
lack
of
hypersensitivity
to
workers
who
have
been
exposed
during
the
manufacture,
application,
and
use
of
the
pesticide
in
the
research
and
experimental
phases.
No
adverse
hypersensitivity
reaction
to
AF36
was
recorded
or
reported
by
a
state
council
or
six
companies
during
use
for
3
or
6
years
[
MRID
45739104;
BPPD
Data
Evaluation
Report,
dated
April
02,
2003d
(
hereinafter
referred
to
as
``
BPPD
Review
­
April
02,
2003d'')].
However,
to
comply
with
the
Agency's
requirements
under
section
6(
a)(
2),
any
incident
of
hypersensitivity
associated
with
the
use
of
this
pesticide
must
be
reported
to
the
Agency.
5.
Data
waivers.
Data
waivers
were
requested
for
the
following
studies:
i.
Acute
dermal
toxicity/
pathogenicity
(
OPPTS
Harmonized
Guideline
885.3100)
ii.
Primary
dermal
irritation
(
OPPTS
Harmonized
Guideline
870.2500)
iii.
Primary
eye
irritation
(
OPPTS
Harmonized
Guideline
870.2400)
iv.
Intravenous,
intracerebral,
intraperitoneal
injection
(
OPPTS
Harmonized
Guideline
885.3200)
v.
Hypersensitivity
study
(
40
CFR
152
 
36)
vi.
Immune
response
(
40
CFR
152
 
38)
With
regards
to
the
dermal
and
eye
irritation
guideline
tests,
it
was
impractical
to
apply
the
end­
use
product,
sterilized
wheat
seeds
inoculated
with
Aspergillus
flavus
AF36,
as
test
material.
Furthermore,
non­
occupational
dermal
and
eye
exposures,
or
exposures
via
any
of
the
routes
in
Unit
III.
5.
i.
 
vi.,
are
not
likely
to
be
above
naturally­
occurring
background
levels
for
the
following
reasons.
First,
Aspergillus
flavus,
a
saprophytic
fungus,
is
a
normal
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Vol.
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134
/
Monday,
July
14,
2003
/
Rules
and
Regulations
constituent
of
the
microflora
in
air
and
soil.
The
naturally
occurring
soil
and
plant
colonizer
is
also
found
on
living
and
dead
plant
material
throughout
the
world.
Aflatoxin­
producing
strains
of
Aspergillus
flavus
are
particularly
prominent
in
hot,
dry
climates
supplemented
with
irrigation
and
are
ubiquitous
components
of
the
natural
Arizona
desert
ecosystem.
Quantities
of
A.
flavus
typically
increase
during
crop
production
and
the
fungus
occurs
widely
on
crop
debris
left
in
the
soil.
Shortly
after
application,
AF36
germinates,
apparently
displaces
the
aflatoxin­
producing
strains
from
cotton
and
the
soil,
and
spore
levels
return
to
normal
background,
without
increase
of
total
A.
flavus.
This
was
demonstrated
in
soil
and
air
monitoring
studies
submitted
over
multiple
years
of
experimental
usage
[
BPPD
Review
­
May
15,
2003].
Thus
exposures
to
AF36
are
not
likely
to
increase
above
those
normally
associated
with
the
naturally
occurring
A.
flavus
background
levels.
Second,
the
application
rate
is
low,
being
less
than
0.01
lb
active
ingredient
per
acre,
and
agricultural
sites
are
treated,
thus
minimizing
nonoccupational
and
residential
exposure.
The
proposed
label
rate
is
less
than
0.01
pound
of
active
ingredient
in
10
pounds
end­
use
product,
or
approximately
1.34
x
107
colony
forming
units
(
cfu)
per
acre.
Finally,
drift
is
not
expected
during
application
based
on
the
large
granular
nature
of
the
pesticide
(
i.
e.,
sterilized
inoculated
wheat
seeds).
In
addition,
only
one
prebloom
application
is
made,
and
cultivation
is
not
recommended
after
application.
Thus,
once
again,
the
potential
for
non­
occupational
dermal
and
residential
exposure
is
unlikely.
The
acute
oral
toxicological
study
demonstrated
an
LD50
of
greater
than
5,000
mg/
kg
with
no
toxicity/
infectivity
effects,
and
demonstrable
clearance
from
organs
examined
post
mortem
[
MRID
43972403;
BPPD
Review
­
April
23,
1996].
This
rationale
supported
the
request
to
waive
the
acute
intraperitoneal
study.
A
hypersensitivity
study
was
waived
since
hypersensitivity
incidents
were
not
reported
from
maximally
exposed
workers
and
researchers
during
the
research
and
experimental
phases
associated
with
the
use
of
the
active
ingredient,
A.
flavus
AF36
[
BPPD
Review
­
April
02,
2003d].
Nevertheless,
reports
of
hypersensitivity
incidents
associated
with
the
use
of
the
pesticide
are
still
required
to
comply
with
FIFRA
section
6(
a)(
2)
requirements.
Submitted
toxicity/
pathogenicity
studies
in
the
rodent
(
required
for
microbial
pesticides)
also
indicate
that
following
oral
and
pulmonary
routes
of
exposure
[
BPPD
Review
­
April
23,
1996;
BPPD
Review
­
April
02,
2003c],
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.
Thus,
the
request
to
waive
the
immune
response
study
was
granted.
On
the
basis
of
the
foregoing
rationales,
and
there
being
no
documented
problems
associated
with
the
non­
aflatoxin
producing
strain,
Aspergillus
flavus
AF36,
data
waivers
for
the
studies
listed
in
Unit
III.
5.
i.
 
vi.,
were
granted
to
the
applicant
for
the
proposed
use
of
Aspergillus
flavus
AF36
on
cotton.
6.
Subchronic,
chronic
toxicity
and
oncogenicity,
and
residue.
Based
on
the
data
generated
in
accordance
with
the
Tier
I
data
requirements
set
forth
in
40
CFR
158.740(
c),
the
Tier
II
and
Tier
III
data
requirements
were
not
triggered
and,
therefore,
not
required
in
connection
with
this
action.
In
addition,
because
the
Tier
II
and
Tier
III
data
requirements
were
not
required,
the
residue
data
requirements
set
forth
in
40
CFR
158.740(
b)
also
were
not
required.

IV.
Aggregate
Exposures
In
examining
aggregate
exposure,
section
408
of
the
FFDCA
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).
There
is
a
potential
for
aggregate
exposure
of
adult
humans,
infants
and
children
to
the
microbe
because
of
the
ubiquitous
distribution
of
Aspergillus
fungal
strains
in
the
environment.
The
Agency
has
considered
the
incremental
exposure
and
risk
associated
with
the
proposed
application
of
this
strain
of
Aspergillus
flavus,
AF36,
as
summarized
below,
and
concludes
that
use
of
AF36
is
not
likely
to
add
an
incremental
risk
above
that
posed
by
the
normal
exposure
of
adults,
infants
and
children
to
Aspergillus
flavus
strains
present
in
the
environment.
In
fact,
use
of
the
pesticide,
AF36,
may
decrease
potential
environmental
aflatoxin
exposure
to
exposed
populations.

A.
Dietary
Exposure
1.
Food.
Based
on
submitted
studies,
the
end­
use
product,
Aspergillus
flavus
AF36,
demonstrates
low
acute
oral
toxicity
category
IV
potential
[
BPPD
Review
­
April
23,
1996].
No
toxicity
endpoints
were
indicated
to
justify
setting
a
numerical
tolerance
for
the
fungal
active
ingredient,
Aspergillus
flavus
AF36.
An
LD50
greater
than
5,000
mg/
kg
body
weight,
in
the
acute
oral
studies
discussed
above,
indicates
that
consumption
of
food
commodities
treated
with
AF36
poses
no
incremental
risk
via
dietary
exposure.
Indeed,
the
submitted
data
indicate
no
toxicity
or
infectivity
of
AF36
in
the
acute
oral
test
mammalian
systems.
Cotton
itself
is
not
a
food
commodity.
Residues
of
A.
flavus
AF36,
the
microbial
active
ingredient,
are
not
likely
to
survive
the
heating
and
pressure
associated
with
the
processing
of
cottonseed
into
cottonseed
meal.
Moreover,
A.
flavus
AF36
will
not
separate
into
the
edible
fraction,
cotton
seed
oil.
Thus,
potential
transfer
of
residues
of
A.
flavus
AF36
to
edible
cotton
food/
feed
commodities
is
not
expected.
Consequently,
human
dietary
exposure
to
A.
flavus
AF36
via
cottonseed
oil,
or
by
secondary
transfer
of
A.
flavus
AF36
residues
to
meat
and
milk
via
cottonseed
meal,
is
not
expected.
Therefore,
the
Agency
has
determined
that
dietary
exposure
to
A.
flavus
AF36
is
not
likely
to
result
in
any
undue
health
effects
and
risk.
While
the
Agency
has
concluded
that
AF36
is
not
likely
to
add
to
the
dietary
burden,
any
potential
contribution
by
AF36
to
aflatoxin
contamination
was
also
considered,
for
a
conservative
estimate
of
the
health
effects
of
this
pesticide.
This
is
because
aflatoxin
is
considered
a
public
health
hazard
(
see
Unit
VII.
D.)
and
AF36
is
proposed
as
a
biocontrol
agent
for
aflatoxin­
producing
strains
of
A.
flavus.
Even
if
AF36
does
not
control
aflatoxin
levels
in
the
treated
cotton
food/
feed
commodities,
a
safety
net
exists
in
the
screening
of
cotton
and
its
by­
products
for
aflatoxin
prior
to
their
introduction
into
the
channels
of
commerce.
For
instance,
FDA
does
not
allow
cotton
seed
products
containing
aflatoxin
above
20
parts
per
billion
(
ppb)
to
be
used
in
dairy
rations
or
above
300
ppb
to
be
used
for
feeding
beef
cattle.
As
previously
stated,
the
registrant
claims
that
quality
control
and
selection
procedures
will
not
allow
aflatoxin
production
in
the
starter
cultures
for
pesticide
manufacture
[
BPPD
review
­
March
29,
1999;
BPPD
review
­
May
14,
1999].
Any
batches
with
aflatoxin
are
to
be
destroyed.
For
these
reasons,
the
Agency
has
determined
that
use
of
AF36
will
not
add
to
the
dietary
burden
of
aflatoxin,
but
is
rather
more
likely
to
ameliorate
aflatoxin
levels
in
treated
cotton
food/
feed
commodities.
Therefore,
dietary
exposure
to
aflatoxin,
as
a
result
of
AF36
use,
is
not
likely
to
be
greater,
and
may
even
be
less,
than
that
which
currently
exists.

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2.
Drinking
water
exposure.
Exposure
to
AF36
via
drinking
water
is
not
likely
to
be
greater
than
current/
existing
exposures
to
A.
flavus
strains.
Potential
risks
via
exposure
to
drinking
water
or
runoff
are
adequately
mitigated
by,
among
other
things,
percolation
through
soil.
Thus,
exposure
via
drinking
water
from
the
proposed
use
of
this
nonaflatoxin
producing
strain
of
Aspergillus
flavus
is
not
likely
to
pose
any
incremental
risk
to
adult
humans,
infants
and
children.
In
fact,
displacement
of
the
toxigenic
strains
of
A.
flavus
by
AF36
may
decrease
exposure
and
risk
to
the
toxigenic
strains
of
A.
flavus
in
the
environment.

B.
Other
Non­
Occupational
Exposure
1.
Dermal
exposure.
The
potential
for
non­
occupational
dermal
exposure
to
AF36
is
unlikely
because
the
potential
use
sites,
are
commercial
and
agricultural,
and
because
of
the
granular
nature
of
the
pesticide,
which
minimizes
spray
drift.
As
discussed
earlier
(
see
Unit
III.),
lack
of
hypersensitivity
incidents,
low
application
rates,
and
return
of
levels
of
Aspergillus
flavus
to
background
shortly
after
germination,
poses
minimal
risk
to
populations
via
dermal,
nonoccupational
exposure.
Thus,
dermal
non­
occupational
exposure
to
the
nonaflatoxin
strain
is
not
likely
to
be
greater
than
the
existing
exposure
to
A.
flavus
at
current
levels.
2.
Inhalation
exposure.
For
the
reasons
stated
immediately
above,
nonoccupational
inhalation
exposure
to
AF36
is
not
expected
to
be
greater
than
that
which
currently
exists
for
A.
flavus
strains.

V.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
the
Agency
to
consider
the
cumulative
effect
of
exposure
to
Aspergillus
flavus
AF36
and
to
other
substances
that
have
a
common
mechanism
of
toxicity.
These
considerations
include
the
possible
cumulative
effects
of
such
residues
on
infants
and
children.
Aspergillus
flavus
AF36
does
not
appear
to
be
toxic
or
pathogenic
to
humans.
There
is
no
indication
that
the
fungus
A.
flavus
AF36
shares
any
common
mechanisms
of
toxicity
with
other
registered
pesticides.
In
addition,
there
are
no
other
registered
pesticide
products
containing
Aspergillus
flavus
AF36,
and
other
A.
flavus
strains
abound
naturally
in
the
environment.
Moreover,
the
displacement
of
the
toxigenic
strain
of
A.
flavus
by
AF36
may
reduce
aflatoxin
contamination
of
cottonseed.
Based
on
the
low
toxicity
potential
of
AF36,
the
fact
that
it
is
non­
aflatoxigenic,
and
the
safety
net
already
in
place
to
monitor
for
aflatoxin,
no
cumulative
or
incremental
effect
is
expected
from
the
use
of
AF36
on
cotton.

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
There
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposures
to
residues
of
A.
flavus
AF36,
in
its
use
as
an
antifungal
agent,
to
the
U.
S.
population,
including
infants
and
children.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
As
discussed
previously,
there
appears
to
be
no
potential
for
harm,
from
this
fungus
in
its
use
as
an
antifungal
agent
via
dietary
exposure
since
the
organism
is
non­
toxic
and
non­
pathogenic
to
animals
and
humans.
The
Agency
has
arrived
at
this
conclusion
based
on
the
very
low
levels
of
mammalian
toxicity
for
acute
oral
and
pulmonary
effects
with
no
toxicity
or
infectivity
at
the
doses
tested
(
see
Unit
III
above).
Moreover,
nonoccupational
inhalation
or
dermal
exposure
is
not
expected
above
background
levels
(
see
Unit
V).
FFDCA
section
408(
b)(
2)(
C)
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
exposure
(
safety)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
unless
EPA
determines
that
a
different
margin
of
exposure
(
safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(
safety)
are
often
referred
to
as
uncertainty
(
safety)
factors.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
the
fungus,
A.
flavus
AF36,
is
non­
toxic
to
mammals,
including
infants
and
children.
Because
there
are
no
threshold
effects
of
concern
to
infants,
children
and
adults
when
A.
flavus
AF36
is
used
as
labeled,
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
As
a
result,
EPA
has
not
used
a
margin
of
exposure
(
safety)
approach
to
assess
the
safety
of
A.
flavus
AF36.

VII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally­
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate.''
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
scientific
basis
for
including,
as
part
of
the
program,
the
androgen­
and
thyroid
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority,
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
The
Agency
is
not
requiring
information
on
the
endocrine
effects
of
this
active
ingredient,
Aspergillus
flavus
AF36,
at
this
time.
The
Agency
has
considered,
among
other
relevant
factors,
available
information
concerning
whether
the
microorganism
may
have
an
effect
in
humans
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects.
There
is
no
known
metabolite
that
acts
as
an
``
endocrine
disrupter''
produced
by
this
microorganism.
The
submitted
toxicity/
infectivity
or
pathogenicity
studies
in
the
rodent
(
required
for
microbial
pesticides)
indicate
that,
following
oral
and
pulmonary
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient
(
see
Unit
III.).
In
addition,
based
on
the
low
potential
exposure
level
associated
with
the
proposed
single,
seasonal,
prebloom
application
of
the
pesticide,
the
Agency
expects
no
adverse
effects
to
the
endocrine
or
immune
systems.

B.
Analytical
Method
The
Agency
proposes
to
establish
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation.
Accordingly,
the
Agency
has
concluded
that
for
an
exemption
from
tolerance,
analytical
methods
are
not
needed
for
enforcement
purposes
for
residues
of
Aspergillus
flavus
AF36
on
treated
cotton.
Nonetheless,
and
for
purposes
of
clarification,
analytical
methods
are
still
required
for
product
characterization,
quality
control,
and
quality
assurance
for
manufacturing
purposes
[
BPPD
review
­
March
29,
1999;
BPPD
review
­
May
14,
1999].
Vegetative
compatibility
tests
are
used
to
screen
starter
cultures
to
identify
the
non­
aflatoxin­
producing
Aspergillus
flavus
AF36
strain.
Starter
cultures
of
AF36
are
also
selected
on
the
basis
of
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Rules
and
Regulations
the
lack
of
aflatoxin
as
monitored
by
standard
thin
layer
chromatography
(
tlc)
procedures
and
visualization
via
scanning
fluorescence
densitometry
scanning.
Other
appropriate
methods
are
required
for
quality
control
to
assure
product
characterization,
the
control
of
human
pathogens
and
other
unintentional
metabolites
or
ingredients
within
regulatory
limits,
and
to
ascertain
storage
stability
and
viability
of
the
pesticidal
active
ingredient.

C.
Codex
Maximum
Residue
Level
There
is
no
Codex
maximum
residue
level
for
residues
of
Aspergillus
flavus
AF36.

D.
Efficacy
Data
PR
Notice
2002­
1
lists
aflatoxin
as
a
public
health
hazard,
for
which
product
performance
or
efficacy
data
are
required
according
to
40
CFR
158.202(
i).
To
demonstrate
that
this
pesticide
may
reduce
aflatoxin­
producing
strains
and
does
not
increase
A.
flavus
populations
above
background
levels,
the
applicant
provided
product
performance
or
efficacy
data
from
multiple
years
of
soil
and
air
monitoring
studies.
Aflatoxin,
one
of
the
most
potent
human
carcinogens,
is
the
metabolite
of
concern
produced
by
the
target
pest,
aflatoxin­
producing
strains
of
Aspergillus
flavus.
As
such,
the
Agency
considers
aflatoxin
a
public
health
hazard.
In
the
soils
of
cotton­
producing
areas
of
Arizona
and
south
Texas,
especially
in
the
dry
regions,
the
toxigenic
strains
are
prominent.
Few
alternatives,
if
any,
exist
to
displace
aflatoxin­
producing
A.
flavus
strains
from
cotton
and
other
crops.
Decontamination
of
crops
via
ammoniation
is
costly,
not
available
universally,
and
decreases
the
value
of
the
crop.
Other
methods
to
reduce
aflatoxin
formation
include
manipulation
of
harvest
date,
costly
irrigation
practices,
and
different
methods
of
harvesting
and
storage
practices.
Efficacy
data
submitted
to
the
Agency
include
monitoring
of
soil
and
air
levels
of
the
toxigenic
and
non­
aflatoxinproducing
strains
of
A.
flavus
AF36
in
the
field
and
on
the
crops.
Results
from
the
environmental
expression
and
population
monitoring
studies,
during
the
experimental
program,
demonstrate
that
a
single
seasonal
application
of
AF36
on
cotton
fields
may
incite
significant
changes
in
the
incidence
of
toxigenic
A.
flavus
strains
resident
in
the
agroecosystem,
without
altering
the
overall
quantity
of
A.
flavus.
Soil
and
air
population
counts
of
A.
flavus
from
treated
fields
were
associated
with
concomitant
decreases
in
incidences
of
toxigenic
A.
flavus,
for
many
of
the
treated
areas
[
BPPD
review
­
May
15,
2003].
Reducing
the
aflatoxin­
producing
populations
of
fungi,
and
the
concomitant
reduction
of
aflatoxin,
a
potent
carcinogen,
is
in
the
public
interest.

VIII.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
the
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0138
in
the
subject
line
on
the
first
page
of
your
submission.
All
objections
and
hearing
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
September
12,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
IX.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0138,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
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Federal
Register
/
Vol.
68,
No.
134
/
Monday,
July
14,
2003
/
Rules
and
Regulations
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

IX.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
exemption
from
the
tolerance
requirement
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

X.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
July
2,
2003.
James
Jones,
Director,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.1206
is
revised
to
read
as
follows:

§
180.1206
Aspergillus
flavus
AF36;
exemption
from
the
requirement
of
a
tolerance.

An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
the
microbial
pesticide
Aspergillus
flavus
AF36
in
or
on
cotton
and
its
food/
feed
commodities.

[
FR
Doc.
03
 
17726
Filed
7
 
11
 
03;
8:
45
am]

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