Document ID: EPA-HQ-OPP-2003-0048-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-01-30T05:00Z

28371
Federal
Register
/
Vol.
64,
No.
101
/
Wednesday,
May
26,
1999
/
Rules
and
Regulations
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
300860;
FRL
 
6081
 
2]

RIN
2070
 
AB78
Aspergillus
flavus
AF36;
Pesticide
Tolerance
Exemption
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
biological
Aspergillus
flavus
AF36,
a
non­
aflatoxin
producing
strain
of
A.
flavus,
on
cotton
when
applied/
used
as
an
antifungal
agent.
The
Interregional
Research
Project
Number
4
(
IR
 
4)
submitted
an
amended
Pesticide
Petition
(
PP)
5E4575
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
and
also
to
comply
with
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
requesting
an
extension
of
the
temporary
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Aspergillus
flavus
AF36.
The
temporary
exemption
from
the
requirement
of
a
tolerance
will
expire
on
December
30,
2000.
DATES:
This
regulation
is
effective
May
26,
1999.
Objections
and
requests
for
hearings
must
be
received
by
EPA
on
or
before
July
26,
1999.
ADDRESSES:
Written
objections
and
hearing
requests,
identified
by
the
docket
control
number
[
OPP
 
300860],
must
be
submitted
to:
Hearing
Clerk
(
1900),
Environmental
Protection
Agency,
Rm.
M3708,
401
M
St.,
SW.,
Washington,
DC
20460.
Fees
accompanying
objections
and
hearing
requests
shall
be
labeled
``
Tolerance
Petition
Fees''
and
forwarded
to:
EPA
Headquarters
Accounting
Operations
Branch,
OPP
(
Tolerance
Fees),
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
A
copy
of
any
objections
and
hearing
requests
filed
with
the
Hearing
Clerk
identified
by
the
docket
control
number,
[
OPP
 
300860],
must
also
be
submitted
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460.
In
person,
bring
a
copy
of
objections
and
hearing
requests
to
Rm.
119,
Crystal
Mall
2
(
CM
#
2),
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
A
copy
of
objections
and
hearing
requests
filed
with
the
Hearing
Clerk
may
be
submitted
electronically
by
sending
electronic
mail
(
e­
mail)
to:
oppdocket
Copies
of
electronic
objections
and
hearing
requests
must
be
submitted
as
an
ASCII
file
avoiding
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
5.1/
6.1
file
format
or
ASCII
file
format.
All
copies
of
electronic
objections
and
hearing
requests
must
be
identified
by
the
docket
number
[
OPP
 
300860].
No
Confidential
Business
Information
(
CBI)
should
be
submitted
through
e­
mail.
Copies
of
electronic
objections
and
hearing
requests
on
this
rule
may
be
filed
online
at
many
Federal
Depository
Libraries.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Shanaz
Bacchus,
c/
o
Product
Manager
(
PM)
90,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460.
Office
location,
telephone
number,
and
e­
mail
address:
9th
fl.,
CM
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
(
703)
308
 
8097,
e­
mail:
bacchus.
shanaz
@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
In
the
Federal
Register
of
February
19,
1999
(
64
FR
8358)
(
FRL
 
6081
 
2),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
of
1996
(
Pub.
L.
104
 
170)
announcing
the
filing
of
a
pesticide
tolerance
petition
by
the
IR
 
4,
New
Jersey
Agricultural
Experiment
Station,
Technology
Center
of
New
Jersey,
Rutgers
University,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390.
The
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner,
IR
 
4.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Aspergillus
flavus
AF36
in/
on
cotton
in
Arizona.
Comments
submitted
to
the
Agency
regarding
the
proposed
use
of
the
antifungal
agent
were
by
the
cotton
growers
in
the
region
who
were
all
in
favor
of
the
extension
of
the
temporary
exemption
from
the
tolerance.
Both
the
toxigenic
and
atoxigenic
strains
are
naturally
occurring
in
Arizona.
The
growers
were
of
the
opinion
that
this
technology
is
likely
to
reduce
the
high
levels
of
the
naturally
occurring,
toxinproducing
strain
of
A.
flavus
by
displacement.
I.
Background
and
Statutory
Findings
New
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
us
in
residential
settings.
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),
published
in
the
Federal
Register
of
February
14,
1996,
(
61
FR
5771)
(
FRL
 
5347
 
5),
which
was
granted
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
on
May
28,
1996
and
expires
May
20,
1999.
Approximately
1,120
acres
of
cotton
in
Yuma
County,
Arizona,
were
treated
at
a
rate
of
10
pounds
(
lbs.)
of
the
pesticide
per
acre
over
the
3
 
year
period.
A
temporary
exemption
from
the
requirement
of
a
tolerance
was
established
in
connection
with
this
EUP
as
published
in
the
Federal
Register
of
June
14,
1996,
(
61
FR
30235)
(
FRL
 
5377
 
6).
No
adverse
effects
were
reported
in
the
annual
reports
which
the
registrant
submitted
as
required
in
the
EUP.
28372
Federal
Register
/
Vol.
64,
No.
101
/
Wednesday,
May
26,
1999
/
Rules
and
Regulations
USDA
ARS
has
amended
the
EUP
and
extended
treatment
to
a
total
of
20,000
acres
of
commercial
cotton
fields
in
5
of
the
15
counties
in
Arizona.
The
aerial
applications
are
to
be
made
in
the
following
counties:
Yuma
(
3,000
A),
LaPaz
(
1,000
A),
Maricopa
(
9,000
A),
Mohave
(
1,000
A)
and
Pinal
(
6,000
A).
The
antifungal
agent
is
applied
prebloom
to
the
soil
of
treated
cotton
fields,
where
the
mycelia
germinate
to
displace
the
naturally
occurring
toxigenic
strain.
Of
the
strains
of
A.
flavus
which
abound
naturally
in
Arizona,
this
atoxigenic
L
strain
comprises
15%
of
the
natural
microbial
population
in
the
soil,
as
opposed
to
the
predominant
S
or
toxigenic
S
strain.

II.
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.
The
toxicological
profile
in
support
of
the
extension
of
the
temporary
exemption
from
a
tolerance
of
the
residues
of
the
atoxigenic
(
non­
toxin
producing)
A.
flavus
AF36
demonstrates
that
the
LD50
of
A.
flavus
AF36
is
greater
than
5,000
milligrams/
kilograms
(
mg/
kg).
No
adverse
clinical
effects
were
observed
after
14
days
in
rats
treated
by
gavage
with
the
microbial
antifungal
agent
and
no
abnormalities
or
adverse
effects
were
observed
in
any
of
the
rats
upon
autopsy.
Studies
were
not
conducted
to
evaluate
the
potential
of
the
active
ingredient
as
an
agent
linked
to
genotoxicity,
or
reproductive,
developmental,
subchronic
or
chronic
effects,
because
the
researchers
have
worked
with
the
proposed
microbial
antifungal
agent
for
several
years
in
laboratory
and
field
settings
with
no
adverse
effects.
Also,
the
organism
is
a
naturally
occurring,
ubiquitous
microbe.

III.
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
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
U.
S.
population,
including
infants
and
children,
to
A.
flavus
AF36
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.

A.
Dietary
Exposure
1.
Food.
Application
of
the
microbial
pesticide
prebloom
in
the
cultural
practice
precludes
the
potential
for
direct
residues
of
A.
flavus
per
se
to
remain
on
the
treated
cotton.
The
proposed
strain
of
A.
flavus,
AF36,
is
atoxigenic,
i.
e.
not
producing
aflatoxin.
Only
the
seed
of
the
treated
commodity,
cotton,
is
likely
to
be
processed
as
food
for
cottonseed
oil.
Residues
of
A.
flavus
AF36
or
its
metabolites
are
likely
to
be
removed
from
cotton
seed
oil
during
this
processing.
Moreover,
the
applications
are
proposed
for
5
of
the
15
counties
of
Arizona
only,
on
3
 
7%
of
the
total
cotton,
thus
minimizing
any
potential
dietary
exposure.
The
Food
and
Drug
Administration
(
FDA)
regulates
the
levels
of
aflatoxin
in
cotton
seed
meal
and
other
commodities
associated
with
the
production
of
cotton.
Cottonseed
is
monitored
for
aflatoxin
content
during
the
ginning
process,
and
all
cotton
seed
from
these
experiments
will
be
closely
monitored
for
aflatoxin
content
as
part
of
the
experimental
program.
On
the
basis
of
the
preceding
discussion,
dietary
exposure
to
the
treated
commodity
is
likely
to
be
minimal
to
human
adults,
infants
and
children.
exposure
to
immunocompromised
human
adults,
infants
and
children.
Moreover,
the
application
of
the
microbial
pesticide
to
specific
counties
during
the
EUP
represents
application
to
approximately
3
 
7%
cultivated
areas
in
these
counties,
thus
minimizing
exposure.
1.
Dermal
exposure.
Nonoccupational
dermal
exposure
and
risk
to
adults,
infants
and
children
are
not
likely
if
the
pesticide
is
used
as
labeled.
The
antifungal
agent
is
a
naturally
occurring
microbe
to
be
applied
to
the
soil
of
cotton
fields
prebloom.
It
is
ubiquitous
in
the
environment.
If
the
microbe
exhibits
dermal
sensitizing
properties
which
is
associated
with
this
genus
of
fungi,
the
boundaries
and
the
large
particle
size
of
the
spores
are
likely
to
maintain
distribution
near
treated
areas
thus
protecting
nearby
atrisk
populations.
Based
on
the
low
toxicity
potential
as
evidenced
by
the
data
submitted,
the
microbial
pesticide
active
ingredient
is
likely
to
pose
a
minimal
to
non­
existent
hazard
if
used
as
labeled.
2.
Inhalation
exposure.
Based
on
the
large
spore
size
of
AF36,
and
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.

IV.
Cumulative
Effects
There
are
no
other
registered
products
containing
Aspergillus
flavus
isolate
AF36
or
any
other
isolates
(
strains)
of
the
microbial
active
ingredient.
Moreover,
data
submitted
to
the
Agency
demonstrate
that
this
strain
does
not
produce
aflatoxin
on
the
crop
or
in
artificial
media
in
the
lab.
Data
submissions
also
show
that
this
strain
has
been
shown
to
exclude
the
aflatoxin­
producing
strain
when
it
is
applied
prior
to
flowering.
Thus,
the
proposed
use
is
not
likely
to
result
in
appreciable
increases
in
the
long­
term
population
of
A.
flavus
on
the
crop
beyond
naturally
occurring
levels.
Furthermore,
there
is
no
expectation
of
cumulative
effects
with
other
pesticides.

V.
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
pre­
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,
EPA
believes
there
are
reliable
data
to
support
the
conclusion
that
there
are
no
threshold
effects
of
concern
to
infants,
children
and
adults
when
A.
flavus
AF36
is
used
as
labeled.
As
a
result,
the
provision
requiring
an
additional
margin
of
exposure
does
not
apply.
The
label
will
require
applicators
and
other
handlers
to
wear
gloves,
a
dust/
mist
filtering
respirator
with
National
Institute
of
Occupational
Safety
and
Health
(
NIOSH)
approval
prefix
N­
95,
R­
95
or
P­
95,
long
sleeved
shirt
and
long
pants,
and
shoes
plus
socks
so
worker
exposure
should
not
be
a
problem.
Label
language
reflecting
potential
dermal
sensitization
is
also
required.

VI.
Other
Considerations
A.
Endocrine
Disruptors
EPA
does
not
have
any
information
regarding
endocrine
effects
of
this
microbial
pesticide
at
this
time.
The
Agency
is
not
requiring
information
on
28373
Federal
Register
/
Vol.
64,
No.
101
/
Wednesday,
May
26,
1999
/
Rules
and
Regulations
the
endocrine
effects
of
this
pesticide
at
this
time;
and
Congress
allowed
3
years
after
August
3,
1996,
for
the
Agency
to
implement
a
screening
and
testing
program
with
respect
to
endocrine
effects.

B.
Analytical
Method(
s)
Starter
cultures
are
screened
on
the
basis
of
vegetative
incompatibility
with
the
toxigenic
strain,
as
well
as
for
aflatoxin
by
standard
procedures,
which
allow
a
zero
tolerance
for
aflatoxin
production.
A.
flavus
AF36
does
not
demonstrate
vegetative
compatibility
with
the
toxigenic
S
strain
and
has
never
been
found
to
produce
aflatoxin.
According
to
the
data
submissions
human
pathogens
are
also
within
regulatory
levels.
Treated
cotton
and
its
byproducts
are
screened
for
aflatoxin
prior
to
introduction
into
the
channels
of
commerce.
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.

C.
Codex
Maximum
Residue
Level
An
exemption
from
temporary
tolerance
for
residues
of
Aspergillus
flavus
isolate
AF36
on
cotton
is
currently
in
effect
in
conjunction
with
an
Experimental
Use
Permit
published
in
the
Federal
Register
of
June
14,
1996
(
61
FR
30235).

VII.
Objections
and
Hearing
Requests
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)
and
as
was
provided
in
the
old
section
408
and
in
section
409.
However,
the
period
for
filing
objections
is
60
days,
rather
than
30
days.
EPA
currently
has
procedural
regulations
which
governs
the
submission
of
objections
and
hearing
requests.
These
regulations
will
require
some
modification
to
reflect
the
new
law.
However,
until
those
modifications
can
be
made,
EPA
will
continue
to
use
those
procedural
regulations
with
appropriate
adjustments
to
reflect
the
new
law.
Any
person
may,
by
July
26,
1999,
file
written
objections
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
Objections
and
hearing
requests
must
be
filed
with
the
hearing
clerk,
at
the
address
given
under
the
``
ADDRESSES''
section
(
40
CFR
178.20).
A
copy
of
the
objections
and/
or
hearing
requests
filed
with
the
hearing
clerk
should
be
submitted
to
the
OPP
docket
for
this
rulemaking.
The
objections
submitted
must
specify
the
provisions
of
the
regulation
deemed
objectionable
and
the
grounds
for
the
objections
(
40
CFR
178.25).
Each
objection
must
be
accompanied
by
the
fee
prescribed
by
40
CFR
180.33(
i).
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
tolerance
objection
fee
waivers,
contact
James
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460.
Office
location,
telephone
number,
and
e­
mail
address:
Rm.
239,
CM
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
(
703)
305
 
5697,
tompkins.
jim@
epa.
gov.
Requests
for
waiver
of
tolerance
objection
fees
should
be
sent
to
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460.
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).
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).
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.

VIII.
Public
Record
and
Electronic
Submissions
EPA
has
established
a
record
for
this
regulation
under
docket
control
number
[
OPP
 
300860]
(
including
any
comments
and
data
submitted
electronically).
A
public
version
of
this
record,
including
printed,
paper
versions
of
electronic
comments,
which
does
not
include
any
information
claimed
as
CBI,
is
available
for
inspection
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
public
record
is
located
in
Rm.
119
of
the
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
CM
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
Objections
and
hearing
requests
may
be
sent
by
e­
mail
directly
to
EPA
at:
opp­
docket@
epa.
gov
E­
mailed
objections
and
hearing
requests
must
be
submitted
as
an
ASCII
file
avoiding
the
use
of
special
characters
and
any
form
of
encryption.
The
official
record
for
this
regulation,
as
well
as
the
public
version,
as
described
in
this
unit
will
be
kept
in
paper
form.
Accordingly,
EPA
will
transfer
any
copies
of
objections
and
hearing
requests
received
electronically
into
printed,
paper
form
as
they
are
received
and
will
place
the
paper
copies
in
the
official
record
which
will
also
include
all
comments
submitted
directly
in
writing.
The
official
record
is
the
paper
record
maintained
at
the
Virginia
address
in
``
ADDRESSES''
at
the
beginning
of
this
document.

IX.
Regulatory
Assessment
Requirements
A.
Certain
Acts
and
Executive
Orders
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).
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)
(
Pub.
L.
104
 
4).
Nor
does
it
require
any
prior
consultation
as
specified
by
Executive
Order
12875,
entitled
Enhancing
the
Intergovernmental
Partnership
(
58
FR
58093,
October
28,
1993),
or
special
considerations
as
required
by
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
28374
Federal
Register
/
Vol.
64,
No.
101
/
Wednesday,
May
26,
1999
/
Rules
and
Regulations
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994),
or
require
OMB
review
in
accordance
with
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
In
addition,
since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
FFDCA
section
408(
d),
such
as
the
[
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.
601
et
seq.)
do
not
apply.
Nevertheless,
the
Agency
previously
assessed
whether
establishing
tolerances,
exemptions
from
tolerances,
raising
tolerance
levels
or
expanding
exemptions
might
adversely
impact
small
entities
and
concluded,
as
a
generic
matter,
that
there
is
no
adverse
economic
impact.
The
factual
basis
for
the
Agency's
generic
certification
for
tolerance
actions
published
on
May
4,
1981
(
46
FR
24950),
and
was
provided
to
the
Chief
Counsel
for
Advocacy
of
the
Small
Business
Administration.

B.
Executive
Order
12875
Under
Executive
Order
12875,
entitled
Enhancing
the
Intergovernmental
Partnership
(
58
FR
58093,
October
28,
1993),
EPA
may
not
issue
a
regulation
that
is
not
required
by
statute
and
that
creates
a
mandate
upon
a
State,
local
or
tribal
government,
unless
the
Federal
government
provides
the
funds
necessary
to
pay
the
direct
compliance
costs
incurred
by
those
governments.
If
the
mandate
is
unfunded,
EPA
must
provide
to
OMB
a
description
of
the
extent
of
EPA's
prior
consultation
with
representatives
of
affected
State,
local,
and
tribal
governments,
the
nature
of
their
concerns,
copies
of
any
written
communications
from
the
governments,
and
a
statement
supporting
the
need
to
issue
the
regulation.
In
addition,
Executive
Order
12875
requires
EPA
to
develop
an
effective
process
permitting
elected
officials
and
other
representatives
of
State,
local,
and
tribal
governments
``
to
provide
meaningful
and
timely
input
in
the
development
of
regulatory
proposals
containing
significant
unfunded
mandates.''
Today's
rule
does
not
create
an
unfunded
Federal
mandate
on
State,
local,
or
tribal
governments.
The
rule
does
not
impose
any
enforceable
duties
on
these
entities.
Accordingly,
the
requirements
of
section
1(
a)
of
Executive
Order
12875
do
not
apply
to
this
rule.
C.
Executive
Order
13084
Under
Executive
Order
13084,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
63
FR
27655,
May
19,
1998),
EPA
may
not
issue
a
regulation
that
is
not
required
by
statute,
that
significantly
or
uniquely
affects
the
communities
of
Indian
tribal
governments,
and
that
imposes
substantial
direct
compliance
costs
on
those
communities,
unless
the
Federal
government
provides
the
funds
necessary
to
pay
the
direct
compliance
costs
incurred
by
the
tribal
governments.
If
the
mandate
is
unfunded,
EPA
must
provide
OMB,
in
a
separately
identified
section
of
the
preamble
to
the
rule,
a
description
of
the
extent
of
EPA's
prior
consultation
with
representatives
of
affected
tribal
governments,
a
summary
of
the
nature
of
their
concerns,
and
a
statement
supporting
the
need
to
issue
the
regulation.
In
addition,
Executive
Order
13084
requires
EPA
to
develop
an
effective
process
permitting
elected
officials
and
other
representatives
of
Indian
tribal
governments
``
to
provide
meaningful
and
timely
input
in
the
development
of
regulatory
policies
on
matters
that
significantly
or
uniquely
affect
their
communities.''
Today's
rule
does
not
significantly
or
uniquely
affect
the
communities
of
Indian
tribal
governments.
This
action
does
not
involve
or
impose
any
requirements
that
affect
Indian
tribes.
Accordingly,
the
requirements
of
section
3(
b)
of
Executive
Order
13084
do
not
apply
to
this
rule.

X.
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
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
the
rule
in
the
Federal
Register.
This
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:
May
14,
1999.

Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division
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
added
to
subpart
D
to
read
as
follows:

§
180.1206
Aspergillus
flavus
AF
36;
Exemption
from
the
requirement
of
a
tolerance.
Aspergillus
flavus
AF
36
is
temporarily
exempt
from
the
requirement
of
a
tolerance
in/
on
cotton
when
used
on
cotton
in
Arizona
in
accordance
with
the
Experimental
Use
Permit
69224
 
EUP
 
1.
The
temporary
exemption
from
the
requirement
of
a
tolerance
will
expire
on
December
30,
2000.

[
FR
Doc.
99
 
13192
Filed
5
 
25
 
99;
8:
45
am]

BILLING
CODE
6560
 
50
 
F
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
300861;
FRL
 
6080
 
6]

RIN
2070
 
AB78
Clomazone;
Extension
of
Tolerance
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
rule
extends
a
timelimited
tolerance
for
residues
of
the
herbicide
clomazone
and
its
metabolites
in
or
on
watermelons
at
0.1
part
per
million
(
ppm)
for
an
additional
2
 
year
period,
to
May
30,
2001.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
authorizing
use
of
the
pesticide
on
watermelons.
Section
408(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
DATES:
This
regulation
becomes
effective
May
26,
1999.
Objections
and