Document ID: EPA-HQ-OPP-2003-0048-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-01-30T05:00Z

28383
Federal
Register
/
Vol.
66,
No.
100
/
Wednesday,
May
23,
2001
/
Rules
and
Regulations
REFRIGERATION
AND
AIR
CONDITIONING
 
Continued
End­
Use
Substitute
Recommendation
Comments
Industrial
process
refrigeration
(
new).
HFC
 
134a/
HBr
(
92/
8)
as
a
substitute
for
CFC
 
11,
CFC
 
12,
CFC
 
114,
CFC
 
115
and
R
 
502.
Acceptable
....................................
Users
are
expected
to
adhere
to
the
3
ppm
Permissible
Exposure
Limit
and
Threshold
Limit
Value
set
by
OSHA
and
ACGIH,
respectively.
Users
are
expected
to
follow
all
recommendations
specified
in
Material
Safety
Data
Sheets
for
HBr,
HFC
 
134a
and
the
blend.
Additional
warning
signs,
worker
education
and
technician
training
is
recommended
to
minimize
exposures.
Refrigerated
transport
(
new)
..........
HFC
 
134a/
HBr
(
92/
8)
as
a
substitute
for
CFC
 
12
and
R
 
502.
Acceptable
....................................
Users
are
expected
to
adhere
to
the
3
ppm
Permissible
Exposure
Limit
and
Threshold
Limit
Value
set
by
OSHA
and
ACGIH,
respectively.
Users
are
expected
to
follow
all
recommendations
specified
in
Material
Safety
Data
Sheets
for
HBr,
HFC
 
134a
and
the
blend.
Additional
warning
signs,
worker
education
and
technician
training
is
recommended
to
minimize
exposures.
Very
low
temperature
refrigeration
(
retrofit
and
new).
PFC
 
330ST,
PFC
 
550HC,
PFC
 
660HC,
PFC
 
1100HC,
PFC
 
1100LT,
PGC
 
100,
PGC
 
150,
PFC
 
331ST,
PFC
 
551HC,
PFC
 
661HC,
PFC
 
1101HC
and
PGC
 
151
assubstitutes
for
CFC
 
13,
CFC
 
113,
CFC
 
114
and
blends
thereof.
Acceptable.

[
FR
Doc.
01
 
12893
Filed
5
 
22
 
01;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
301124;
FRL
 
6781
 
7]

RIN
2070
 
AB78
Aspergillus
flavus
AF36;
Extension
of
Temporary
Exemption
From
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
extends
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
biological
Aspergillus
flavus
AF36,
(
A.
flavus)
a
non­
aflatoxin
producing
strain
of
A.
flavus,
on
cotton
when
applied
or
used
as
aerial
prebloom
applications
to
cotton
in
specified
counties
of
Arizona.
The
Interregional
Research
Project
Number
4
(
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,
submitted
an
amended
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
requesting
the
temporary
exemption.
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,
2003.
DATES:
This
regulation
is
effective
May
23,
2001.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP
 
301124,
must
be
received
by
EPA
on
or
before
July
23,
2001.
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
III.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP
 
301124
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;
and
e­
mail
address:
bacchus.
shanaz@
epa.
gov.

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:

Categories
NAICS
Examples
of
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
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/
Vol.
66,
No.
100
/
Wednesday,
May
23,
2001
/
Rules
and
Regulations
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
http://
www.
epa.
gov/.
To
access
this
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
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_
180/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP
 
301124.
The
official
record
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).
This
official
record
includes
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
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
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
#
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
Findings
In
the
Federal
Register
of
May
26,
1999
(
64
FR
28371)
(
FRL
 
6081
 
2),
EPA
issued
a
final
rule
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
(
Public
Law
104
 
170)
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
A.
flavus
AF36
on
cotton
grown
in
5
counties
in
Arizona
(
40
CFR
180.1206).
This
final
rule
included
a
summary
of
the
Agency's
assessment
of
the
health
effects
data
submitted
in
support
of
the
extension
of
the
temporary
tolerance
exemption.
The
temporary
exemption
from
tolerance
was
extended
until
December
2001
(
64
FR
35049,
June
30,
1999)
(
FRL
 
6087
 
3)
to
allow
for
passage
of
the
treated
commodities
through
the
channels
of
trade.
Comments
submitted
to
the
Agency
regarding
the
use
of
this
competitive
fungal
agent
were
by
the
cotton
growers
in
the
region
who
were
all
in
favor
of
the
extension
of
the
exemption
from
the
temporary
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,
toxin­
producing
strain
of
A.
flavus
by
displacement.
No
adverse
effects
were
reported
in
the
yearly
annual
reports
of
the
Experimental
Use
Permit,
and
in
some
instances
aflatoxin
levels
of
cotton
seed
were
reduced
in
treated
cotton.
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
use
in
residential
settings.
The
fungal
agent
is
applied
prebloom
to
the
soil
of
treated
cotton
fields.
When
conditions
are
appropriate,
the
AF
36
spores
land
on
the
cotton
plant
and
germinate
to
displace
the
naturally
occurring
toxigenic
strain.
No
adverse
effects
were
reported
in
the
annual
reports
which
the
registrant
submitted
as
required
in
the
EUP.
This
extension
of
the
exemption
from
the
requirement
of
a
temporary
tolerance
is
associated
with
an
extension
of
an
Experimental
Use
Permit
(
EUP,
EPA
Reg.
No.
69224
 
EUP
 
1).
This
extension
of
the
EUP
will
allow
aerial
application
of
A.
flavus
AF36
in
the
following
counties
of
Arizona:
Yuma
(
3,300
acres),
Maricopa
(
13,150
acres),
Mohave
(
1,700
acres)
and
Pinal
(
1,850
acres).
This
final
rule
extends
the
temporary
exemption
from
a
tolerance
for
residues
of
Aspergillus
flavus
AF36
on
cotton
until
December
30,
2003.
Of
the
strains
of
A.
flavus
found
naturally
in
Arizona,
this
atoxigenic
strain
comprises
about
15%
of
the
natural
microbial
population
in
the
soil,
as
opposed
to
the
predominant
S
or
toxigenic
S
strain.
Summaries
of
the
toxicological
profile
and
other
relevant
manufacturing
and
health
effects
data,
to
comply
with
the
guideline
requirements
of
the
Food
Quality
Protection
Act
of
1996,
were
reported
in
the
Federal
Register
publication
of
the
final
rule
of
May
26,
1999,
extending
the
temporary
tolerance
exemption.
Based
on
the
previously
submitted
data
outlined
in
the
final
rule,
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
this
experimental
use
permit.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
continues
to
require
that
the
pesticide
must
not
be
applied
within
a
boundary
of
400
feet
of
residential
areas,
schools,
daycare
and
health
care
facilities
and
hospitals
to
minimize
exposure
to
human
adults,
infants
and
children.
Data
have
been
submitted
to
demonstrate
that
this
strain
excludes
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.

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/
Vol.
66,
No.
100
/
Wednesday,
May
23,
2001
/
Rules
and
Regulations
Furthermore,
there
is
no
expectation
of
cumulative
effects
with
other
pesticides,
because
this
is
the
only
registered
experimental
microbe
in
this
genus.
As
in
the
earlier
EUP,
the
Agency
requires
that
applicators
and
other
handlers
must
wear
gloves,
a
dust/
mist
filtering
respirator
with
NIOSH
approval
prefix
N
 
95,
R
 
95
or
P
 
95,
long
sleeved
shirt
and
long
pants,
and
shoes
plus
socks
to
mitigate
potential
worker
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.
Treated
cotton
and
its
by
products
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
A.
flavus
isolate
AF36
on
cotton
(
40
CFR
180.1206)
is
currently
in
effect
in
conjunction
with
an
Experimental
Use
Permit
(
61
FR
30235,
June
14,
1996,
and
extended
to
expire
in
December
2001)
(
FRL
 
5377
 
6).

III.
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
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
control
number
OPP
 
301124
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
july
23,
2001.
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
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.
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
control
number
OPP
 
301124,
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:
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).

IV.
Regulatory
Assessment
Requirements
This
final
rule
extends
a
temporary
exemption
from
the
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
(
58
FR
51735,
October
4,
1993).
This
final
rule
does
not
contain
any
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Federal
Register
/
Vol.
66,
No.
100
/
Wednesday,
May
23,
2001
/
Rules
and
Regulations
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
FIFRA
section
18
petition
under
FFDCA
section
408,
such
as
the
[
tolerance]
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
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
(
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.''

V.
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:
May
9,
2001.
Janet
L.
Anderson,
Director,
Biopesticide
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
revised
to
read
as
follows:

§
180.1206
Aspergillus
flavus
AF36.
Aspergillus
flavus
AF36
is
temporarily
exempt
from
the
requirement
of
a
tolerance
in
or
on
cotton
when
used
on
cotton
in
Arizona
in
accordance
with
the
Experimental
Use
Permit
69224
 
EUP
 
1.
The
temporary
exemption
from
a
tolerance
will
expire
on
December
30,
2003.
[
FR
Doc.
01
 
12900
Filed
5
 
22
 
01;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
301132;
FRL
 
6784
 
7]

RIN
2070
 
AB78
Thiamethoxam;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
thiamethoxam
and
its
metabolite
in
or
on
tuberous
and
corm
vegetables
crop
subgroup,
fruiting
vegetables
crop
group,
tomato
paste,
cucurbit
vegetables
crop
group,
and
pome
fruits
crop
group.
Syngenta
Crop
Protection,
Inc.
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
DATES:
This
regulation
is
effective
May
23,
2001.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP
 
301132,
must
be
received
by
EPA
on
or
before
July
23,
2001.
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
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP
 
301132
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Dani
Daniel,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
5409;
and
e­
mail
address:
daniel.
dani@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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