Document ID: EPA-HQ-OPP-2003-0048-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-01-30T05:00Z

<
PRE>
[
Federal
Register:
July
17,
2002
(
Volume
67,
Number
137)]
[
Rules
and
Regulations]
[
Page
46884­
46888]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr17jy02­
21]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP­
2002­
0093;
FRL­
7185­
4]
RIN
2070
Aspergillus
flavus
AF36;
Amendment,
Temporary
Exemption
From
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Final
rule.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
This
regulation
amends
an
existing
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
atoxigenic
microbial
pesticide,
Aspergillus
flavus
AF36
on
cotton
consistent
with
the
Experimental
Use
Permit
69224­
EUP­
1,
which
will
now
allow
for
application
to
cotton
in
certain
counties
in
Arizona
and
Texas.
Interregional
Research
Project
Number
4
(
IR­
4),
on
behalf
of
the
USDA/
ARS
Southern
Regional
Research
Center,
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996,
requesting
the
temporary
tolerance
exemption
amendment.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Aspergillus
flavus
AF36.
The
temporary
tolerance
exemption
will
expire
on
December
30,
2004.

DATES:
This
regulation
is
effective
July
17,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP­
2002­
0093,
must
be
received
by
EPA
on
or
before
September
16,
2002.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP­
2002­
0093
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Shanaz
Bacchus,
c/
o
Product
Manager
(
PM)
90,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
703­
308­
8097;
e­
mail
address:
<
A
HREF="
mailto:
bacchus.
shanaz@
epa.
gov">
bacchus.
shanaz@
epa.
gov</
A>.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Examples
of
Categories
NAICS
codes
potentially
affected
entities
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

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

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
<
A
HREF="
http://
frwebgate.
access.
gpo.
gov/
cgibin
leaving.
cgi?
from=
leavingFR.
html&
log=
linklog&
to=
http://
www.
epa.
gov/">
http://
w
ww.
epa.
gov/</
A>.
To
access
this
[[
Page
46885]]

document,
on
the
Home
Page
select
  
Laws
and
Regulations,''
  
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
  
Federal
Register­­
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
<
A
HREF="
http://
frwebgate.
access.
gpo.
gov/
cgibin
leaving.
cgi?
from=
leavingFR.
html&
log=
linklog&
to=
http://
www.
epa.
gov/
fedrgstr/"
>
http://
www.
epa.
gov/
fedrgstr/</
A>.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
<
A
HREF="
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml­­
00/
Title">
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml­­
00/
Title</
A>
­­
40/
40cfr180
­­
00.
html,
a
beta
site
currently
under
development.
2.
In
person.
The
Agency
has
established
an
official
docket
for
this
action
under
docket
ID
number
OPP­
2002­
0093.
The
official
docket
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
Interested
parties
should
consult
both
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
docket
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
docket,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
<
greek­
i>
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.

II.
Background
and
Statutory
Authority
A.
Statutory
Authority
Section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
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)
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)
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)
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.

B.
Factual
Background
This
extension
of
the
temporary
exemption
from
the
requirement
of
a
tolerance
is
associated
with
an
extension
of
an
Experimental
Use
Permit
(
69224­
EUP­
1),
which
was
granted
in
May
1996
to
the
Southern
Regional
Research
Center,
United
States
Department
of
Agriculture,
Agricultural
Research
Service
(
USDA
ARS),
1100
Robert
E.
Lee
Blvd.,
New
Orleans,
LA
70179­
0687.
Both
the
temporary
exemption
from
tolerance
and
the
Experimental
Use
Permit
in
Arizona
expire
December
30,
2003.
In
the
Federal
Register
of
(
March
25
2002,
57
FR
13628)
(
FRL­
6827­
8),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
(
Public
Law
104­
170),
announcing
the
filing
of
an
amended
pesticide
tolerance
petition
(
PP
5E4575)
by
Interregional
Research
Project
Number
4
(
IR­
4),
New
Jersey
Agricultural
Experiment
Station,
Technology
Center
of
New
Jersey,
681
U.
S.
Highway
<
greek­
i>
1
South,
North
Brunswick,
NJ
08902­
3390
on
behalf
of
the
USDA/
ARS
Southern
Regional
Research
Center,
1100
Robert
E.
Lee
Blvd.,
P.
O.
Box
19687,
New
Orleans,
LA
70179.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner,
Dr.
Michael
Braverman.
It
referred
to
data
previously
evaluated
and
summarized
by
the
Agency
as
published
in
the
Federal
Register
of
May
26
1999
(
64
FR
28371)
(
FRL­
6081­
2),
and
the
extension
of
the
temporary
tolerance
exemption
as
published
in
the
Federal
Register
of
May
23
2001
(
66
FR
28383)
(
FRL­
6781­
7).
The
petition
requested
that
40
CFR
part
180.1206
be
amended
by
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Aspergillus
flavus
AF36
on
cotton
in
certain
counties
in
Texas
in
addition
to
the
current
exemption
from
temporary
tolerance
on
cotton
in
Arizona.
This
petition
also,
requested
that
this
temporary
exemption
from
a
tolerance
be
extended
to
December
30,
2005.
Several
comments
were
received
in
favor
of
the
amendment
to
allow
use
of
the
microbial
pesticide
in
Texas.
The
growers
were
of
the
opinion
that
the
use
of
this
active
ingredient
is
likely
to
reduce
the
high
levels
of
naturally
occurring
aflatoxin­
producing
strain.
Aspergillus
flavus
AF36
has
been
found
at
a
range
of
less
than
1
to
approximately
5%
in
certain
regions
of
Texas.
One
comment
was
received
requesting
the
Agency
to
re­
evaluate
the
science
of
the
proposed
program
and
that
the
risks
associated
with
the
use
of
the
active
ingredient
be
considered
before
a
permanent
exemption
from
a
tolerance
is
issued.
The
main
concerns
in
this
comment
were
the
requirement
for
uniform
standards
in
the
expression
of
aflatoxin
levels
found
in
the
crop;
the
practical
significance
of
the
proposed
treatment
method
in
reducing
aflatoxin
contamination;
and
the
significance
of
the
host
stress
in
the
expression
of
pathogenicity
by
Aspergillus
flavus.
Considering
each
of
these
points,
first,
the
commenter
referred
to
the
mixing
of
units
used
to
measure
aflatoxin
contamination.
This
comment
specifically
referred
to
the
experimental
researcher's
reports,
which
include
measurement
of
aflatoxin
levels
as
micrograms
per
gram
of
cottonseed
rather
than
the
typical
expression
of
micrograms
per
kilogram
of
cottonseed.
In
data
submitted
to
the
Agency,
there
is
no
indication
that
the
company
was
in
error
or
misrepresenting
the
aflatoxin
values.
In
all
cases,
EPA
is
careful
to
pay
close
scrutiny
to
the
units
of
measure
in
data
they
review
and
the
implications
made
from
the
stated
values.
Secondly,
the
efficacy
of
the
pesticidal
product
to
reduce
the
level
of
aflatoxin
in
commercial
crops
was
questioned
in
the
comments.
The
Agency
requires
that
the
company
present
data
to
confirm
their
claim
to
control
a
public
health
hazard.
The
submitted
data
are
available
in
the
public
docket
and
have
been
reviewed.
These
data
indicate
that
when
Aspergillus
flavus
AF36
is
used,
a
higher
percentage
of
the
treated
commodity
meets,
or
is
less
than,
the
standards
of
aflatoxin
required
by
the
Food
and
Drug
Administration
(
FDA),
and
the
aflatoxin
contamination
in
the
experimental
region
is
lowered.
The
growers
ultimately
decide
if
the
reduced
aflatoxin
contamination
is
worth
the
treatment
cost,
but
all
cotton
and
its
by­
products
sold
for
food/
feed
must
meet
the
FDA
aflatoxin
standard.

[[
Page
46886]]
Regarding
testing
of
the
atoxigenic
fungus,
Aspergillus
flavus
AF36,
on
stressed
or
immunosuppressed
species
to
detect
any
pathogenic
potential
in
plants,
insects,
or
mammals,
EPA's
guideline
requirements
are
designed
to
address
the
normal
immune
response
to
microbial
exposure.
These
tests
include
non­
self/
foreign
recognition
and
response
or
clearance
by
the
immune
system
over
time.
EPA
is
examining
new
methods
that
may
address
the
potential
of
a
microbe
to
infect
stressed
or
immunocompromised
hosts.
In
the
interim,
special
measures
have
been
included
in
the
experimental
treatments
to
reduce
exposure
to
Aspergillus
flavus
AF36
outside
of
the
designated
treatment
areas.
The
experimental
plan
also
requires
extensive
data
collection
to
examine
the
fate
and
persistence
of
Aspergillus
flavus
AF36
as
a
component
of
the
local
fungal
population.
Exposure
to
Aspergillus
flavus
is
inevitable,
because
the
fungus
normally
occurs
in
the
environment.
Given
the
ubiquitous
nature
of
various
strains
of
Aspergillus
flavus,
the
precautions
associated
with
this
experimental
program,
data
indicating
no
undue
adverse
health
effects
to
test
rodent
species
by
oral
ingestion
of
Aspergillus
flavus
AF36,
as
well
as
the
current
FDA
monitoring
of
aflatoxin
levels,
there
is
a
reasonable
certainty
of
no
harm
resulting
from
the
use
of
the
non­
aflatoxin­
producing
fungus,
Aspergillus
flavus
AF36.

III.
Toxicological
Profile
and
Risk
Assessment
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.
Based
on
the
data
and
analyses
outlined
in
the
Federal
Register
of
May
26
1999
(
66
FR
28371),
and
summarized
below,
EPA
has
concluded
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
U.
S.
population,
including
infants
and
children,
to
residues
of
Aspergillus
flavus
AF36
arising
from
the
limited
use
pattern
of
the
experimental
use
permit.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
1.
Food.
The
cultural
practice
allows
application
of
the
microbial
pesticide
prebloom
to
cotton.
This
precludes
the
potential
for
direct
residues
of
Aspergillus
flavus
AF36
per
se
to
remain
on
the
treated
cotton.
Only
the
seed
of
the
treated
commodity,
cotton,
is
likely
to
be
processed
as
food
for
cottonseed
oil.
Residues
of
Aspergillus
flavus
AF36
or
its
metabolites
are
likely
to
be
removed
from
cotton
seed
oil
during
this
processing.
In
addition,
the
data
submitted
demonstrate
that
the
proposed
strain
of
Aspergillus
flavus
AF36,
has
a
low
toxicity
potential,
and,
therefore,
is
likely
to
pose
a
minimal
to
non­
existent
hazard
if
used
as
labeled.
The
acute
oral
LD<
INF>
50</
INF>
of
rats
treated
by
gavage
for
14
days
is
greater
than
5,000
mg/
kg.
Further,
the
proposed
strain
of
Aspergillus
flavus,
AF36,
does
not
produce
aflatoxin.
Aflatoxin
is
regulated
on
the
by­
products
of
cotton
by
the
Food
and
Drug
Administration.
The
May
23
2001
Federal
Register
Notice
also,
discusses
that
no
adverse
effects
were
reported
in
the
annual
reports
of
the
Experimental
Use
Permit
69224­
EUP­
1,
and,
in
some
instances,
aflatoxin
levels
of
cotton
seed
were
reduced
in
treated
cotton
(
May
23,
2001,
66
FR
28383).
2.
Dermal
exposure.
Non­
occupational
dermal
exposure
and
risk
to
adults,
infants
and
children
are
not
likely
if
the
pesticide
is
used
as
labeled.
If
the
microbe
exhibits
dermal
sensitizing
properties
which
is
associated
with
this
genus
of
fungi,
the
boundaries
are
likely
to
maintain
distribution
near
treated
areas
thus
protecting
nearby
at­
risk
populations.
To
further
minimize
exposure
to
immunocompromised
or
sensitive
populations,
infants
and
children,
the
Agency
continues
to
require
that
the
pesticide
must
not
be
applied
within
a
boundary
of
400
feet
of
schools,
daycare
and
health
care
facilities
and
hospitals.
3.
Inhalation
exposure.
Based
on
the
method
of
application
to
the
soil
of
cultivated
cotton
fields,
prebloom
with
set
boundaries,
non­
occupational
inhalation
exposure
and
risk
to
human
adults,
children
and
infants
are
likely
to
be
minimal.
4.
Determination
of
safety
for
U.
S.
population,
infants
and
children.
FFDCA
section
408
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.
In
this
instance,
based
on
the
above
findings,
EPA
believes
there
are
reliable
data
to
support
the
conclusion
that
there
are
no
threshold
effects
of
concern
to
infants,
children,
and
adults
when
Aspergillus
flavus
AF36
is
used
as
labeled,
and
that
no
additional
margin
of
exposure
is
necessary.
5.
Cumulative
effects.
This
is
the
only
microbe
in
the
genus
Aspergillus
which
is
in
an
experimental
use
program
at
this
time.
Aspergillus
species
are
naturally
occurring
ubiquitous
fungi,
such
that
exposure
to
various
species
is
normal.
The
data
submitted
to
the
Agency
support
the
claim
that
Aspergillus
flavus
AF36
is
non­
aflatoxin
producing.
When
applied
prior
to
flowering,
Aspergillus
flavus
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
populaton
of
Aspergillus
flavus
on
the
crop
beyond
naturally
occurring
levels.
Furthermore,
there
is
no
expectation
of
cumulative
effects
with
other
pesticides.

IV.
Other
considerations
1.
Endocrine
disruptors.
EPA
does
not
have
any
information
regarding
endocrine
effects
of
this
microbial
pesticide
at
this
time.
2.
Analytical
methods.
Starter
cultures
are
screened
on
the
basis
of
vegetative
incompatibility
with
the
toxigenic
strain.
Aspergillus
flavus
AF
36
does
not
demonstrate
vegetative
compatibility
with
the
aflatoxin­
producing
S
strain.
Aflatoxin
production
is
monitored
by
standard
thin
layer
chromatography
(
tlc)
procedures
and
visualization
via
scanning
fluorescence
densitometry
and
there
is
a
zero
tolerance
for
aflatoxin.
Human
pathogens
are
reported
to
be
within
regulatory
levels
(
May
26
1999,
64
FR
28371).
Treated
cotton
and
its
by­
products
are
screened
for
aflatoxin
prior
to
introduction
into
the
channels
of
commerce.
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.
3.
Codex
maximum
residue
level.
There
is
no
codex
maximum
residue
level
for
Aspergillus
flavus
AF36.
V.
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
[[
Page
46887]]

FFDCA
by
the
FQPA
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
2002­
0093
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
September
16,
2002.
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
(
1900),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
C400,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC
20460.
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
(
202)
260­
4865.
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
<
A
HREF="
mailto:
tompkins.
jim@
epa.
gov">
tompkins.
jim@
epa.
gov</
A>,
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.
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.
3.
Copies
for
the
docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VIII.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP­
2002­
0093,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
<
A
HREF="
mailto:
opp­
docket@
epa.
gov">
oppdocket
epa.
gov</
A>.
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).

VI.
Regulatory
Assessment
Requirements
This
final
rule
establishes
an
amended
exemption
from
the
temporary
tolerance
requirement
under
FFDCA
section
408(
d)
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
(
October
4
1993,
58
FR
51735).
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
(
May
22
2001,
66
FR
28355).
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
(
February
16
1994,
59
FR
7629);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
April
23
1997,
62
FR
19885).
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
FFDCA
section
408(
d),
such
as
the
amended
temporary
tolerance
exemption
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.
601et
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
[[
Page
46888]]

levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
August
10
1999,
64
FR
43255).
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
FFDCA
section
408(
n)(
4).
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
(
November
6,
2000,
65
FR
67249).
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.

VII.
Submission
to
Congress
and
the
Comptroller
General
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:
June
27,
2002.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
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
374.

2.
Section
180.1206
is
revised
to
read
as
follows:

Sec.
180.1206
Aspergillus
flavus
AF36.

Aspergillus
flavus
AF36
is
temporarily
exempt
from
the
requirement
of
a
tolerance
in
or
on
cotton.
The
temporary
exemption
from
a
tolerance
will
expire
on
December
30,
2004,
consistent
with
the
Experimental
Use
Permit
69224­
EUP­
1.

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