Document ID: EPA-HQ-OPP-2002-0277-0001
Agency: epa
Document Type: Rule
Title: Urea; Exemption from the Requirement of a Tolerance
Posted Date: 2002-12-26T05:00Z

78715
Federal
Register
/
Vol.
67,
No.
248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
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.

§
180.1001
[
Amended]

2.
In
subpart
D,
§
180.1001
is
amended
by:
i.
Removing
from
the
table
in
paragraph
(
c)
the
entry
for
urea
``
use
as
a
stabilizer
and
inhibitor.''
ii.
Removing
from
the
table
in
paragraph
(
d)
the
entry
for
urea
``
use
as
an
adjuvant/
intensifier
for
herbicides.''
iii.
Removing
from
the
table
in
paragraph
(
e)
the
entry
for
urea
``
use
as
a
stabilizer
and
inhibitor.''

§
180.1117
[
Removed]

3.
Section
180.1117
is
removed.
[
FR
Doc.
02
 
32563
Filed
12
 
24
 
02;
8:
45
a.
m.]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0277;
FRL
 
7284
 
2]

Urea;
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
urea
when
used
in
pesticide
formulations.
Ecolab,
Inc.
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
urea.
This
final
rule
is
being
published
in
today's
Federal
Register
with
a
companion
Direct
Final
Rule
entitled
``
Urea:
Revocation
of
Tolerance
Exemptions''
DATES:
This
regulation
is
effective
December
26,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0277,
must
be
received
on
or
before
February
24,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Treva
C.
Alston,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8373;
e­
mail
address:
alston.
treva@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
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
table
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.
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
 
2002
 
0277.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
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.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
April
7,
2000
(
65
FR
18324)
(
FRL
 
6499
 
7),
EPA
issued
a
notice
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
(
FQPA)
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
9E6028)
by
Ecolab,
Inc.,
370
N.
Wabasha
Street,
St.
Paul,
MN
55102.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Ecolab.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.1001
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
urea
in
or
on
raw
agricultural
commodities,
in
processed
commodities,
and
in
or
on
meat
and
meat
by
products
of
cattle,
sheep,
hogs,
goats,
horses,
poultry,
milk,
dairy
products,
eggs,
seafood
and
shellfish,
and
fruits
and
vegetables
when
such
residues
result
from
the
use
of
urea
as
a
component
of
a
food
contact
surface
sanitizing
solution
for
use
in
food
handling
establishments.
Section
408(
b)(
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
from
tolerance
is
``
safe.''
Section
408(
b)(
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
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/
Vol.
67,
No.
248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
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.
*
*
*''
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
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
nature
of
the
toxic
effects
caused
by
urea
are
discussed
in
this
unit.
In
the
Federal
Register
of
April
15,
2002
(
67
FR
18197)
(
FRL
 
6860
 
6),
the
Agency
published
its
report
of
the
Tolerance
Reassessment
Decision
for
urea.
This
Report
contained
the
hazard
characterization
of
urea.
For
a
complete
description
of
the
use
summary,
hazard
characterization,
exposure
assessment
and
risk
assessment
findings,
see
the
Notice
of
April
15,
2002.
These
data
are
considered
by
the
Agency
to
be
sufficient
to
assess
the
potential
hazard
to
humans,
including
infants
and
children.

IV.
Summary
of
Risk
Assessment
Findings
From
the
available
animal
studies
and
other
data,
EPA
has
concluded
that
urea
exhibits
a
low
toxicity
and
exposures
to
urea
used
either
as
an
active
or
inert
pesticide
ingredient
present
a
reasonable
certainty
of
no
harm
to
human
health.

V.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify
or
revoke
a
tolerance,
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.
Urea
is
a
low
toxicity
chemical.
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
urea
has
a
common
mechanism
of
toxicity
with
other
subtances
or
how
to
include
these
pesticide
chemicals
in
a
cumulative
risk
assessment.

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
Based
on
the
available
data,
EPA
concludes
that
urea
does
not
pose
a
dietary
risk
under
reasonable
foreseeable
circumstances.
Accordingly,
EPA
finds
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
chldren
from
aggregate
exposure
to
urea.
Because
of
the
low
toxicity
of
urea,
a
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reason,
the
tenfold
safety
factor
for
the
protection
of
infants
and
children
is
unnecessary.

VII.
Other
Considerations
A.
Endocrine
Disruptors
FQPA
requires
EPA
to
develop
a
screening
program
to
determine
whether
certain
substances,
including
all
pesticide
chemicals
(
both
inert
and
active
ingredients),
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effect.
EPA
has
been
working
with
interested
stakeholeders
to
develop
a
screening
and
testing
program
as
well
as
a
priority
setting
scheme.
As
the
Agency
proceeds
with
implementation
of
this
program,
further
testing
of
products
containing
urea
may
be
required.

B.
Analytical
Method(
s)

An
analytical
method
is
not
required
for
enforcement
purposes
since
the
Agency
is
establishing
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation.

C.
Existing
Tolerances
There
are
four
existing
tolerance
exemptions
for
urea.
They
are
as
follows:
§
180.1001(
c),
(
d),
and
(
e);
and
§
180.1117.
However,
in
today's
Federal
Register,
the
Agency,
acting
on
its
on
initiative,
published
a
direct
final
rule
revoking
these
four
tolerance
exemptions
as
they
are
no
longer
necessary.
No
uses
are
lost
by
revoking
the
above
four
tolerance
exemptions,
as
the
tolerance
exemption
established
in
this
rule
will
cover
these
uses
and
the
use
requested
by
the
petitioner.
D.
International
Tolerances
The
Agency
is
not
aware
of
any
country
requiring
a
tolerance
for
urea
nor
have
any
CODEX
Maximum
Residue
Levels
been
established
for
any
food
crops
at
this
time.

E.
List
4A
Classification
Based
on
its
low
toxicity,
urea
will
be
classified
as
a
List
4A
inert
ingredient.
List
4A
inert
ingredients
are
minimal
risk
inert
ingredients.
Minimal
risk
does
not
imply
no
risk
under
any
circumstances.
Every
substance
can
present
some
risk
in
certain
circumstances.
Minimal
risk
is
used
to
indicate
a
substance
for
which
there
is
no
information
to
indicate
that
there
is
a
basis
for
concern.
Thus,
the
tolerance
exemption
will
be
established
in
40
CFR
180.950
which
holds
minimal
risk
chemicals
instead
of
40
CFR
180.1001
as
requested
by
the
petitioner,
Ecolab.

VIII.
Conclusions
Based
on
the
information
in
the
record,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
residues
of
urea.
Accordingly,
EPA
finds
that
exempting
urea
from
the
requirement
of
a
tolerance
will
be
safe.

IX.
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
ID
number
OPP
 
2002
 
0277
in
the
subject
line
on
the
first
page
of
your
submission.
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E:\
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Federal
Register
/
Vol.
67,
No.
248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
February
24,
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
 
2002
 
0277,
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.
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).

X.
Regulatory
Assessment
Requirements
This
final
rule
establishes
an
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).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866,
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
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.
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
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248
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26,
2002
/
Rules
and
Regulations
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.

XI.
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:
December
12,
2002.
Peter
Caulkins,
Acting
Director,
Registration
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
371.

2.
Section
180.950
is
amended
by
adding
alphabetically
the
following
ingredient
to
the
table
in
paragraph
(
e)
to
read
as
follows.

§
180.950
Tolerance
exemptions
for
minimal
risk
active
and
inert
ingredients.

*
*
*
*
*

(
e)
*
*
*

Chemical
CAS
No.

*
*
*
*
*
Urea
...................................................................................................................................
57
 
13
 
6
[
FR
Doc.
02
 
32564
Filed
12
 
24
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
261
[
FRL
 
7429
 
3]

RIN
2003
 
AA00
Regulatory
Innovations:
Pilot­
Specific
Rule
for
Electronic
Materials
in
the
EPA
Region
III
Mid­
Atlantic
States;
Hazardous
Waste
Management
System;
Modification
of
the
Hazardous
Waste
Program;
Cathode
Ray
Tubes
AGENCY:
Environmental
Protection
Agency.
ACTION:
Direct
final
rule.

SUMMARY:
Many
used
cathode
ray
tubes
(
CRTs)
are
currently
classified
as
characteristic
hazardous
wastes
under
the
Resource
Conservation
and
Recovery
Act
(
RCRA).
Such
CRTs
are
therefore
subject
to
the
hazardous
waste
regulations
of
RCRA
Subtitle
C
unless
they
come
from
a
household
or
a
conditionally
exempt
small
quantity
generator.
Today
EPA
is
taking
direct
final
action
on
a
revision
to
its
hazardous
waste
program
under
RCRA
to
exclude
used
CRTs
and
glass
removed
from
CRTs
from
the
definition
of
``
solid
waste''
in
the
EPA
Region
III
Mid­
Atlantic
States
(
which
include
the
States
of
Delaware,
Maryland,
and
West
Virginia,
the
Commonwealths
of
Pennsylvania
and
Virginia,
and
the
District
of
Columbia).
Additionally,
the
preamble
to
this
rule
clarifies
when
used
CRTs
and
other
used
electronic
equipment
become
a
``
solid
waste.''
This
rule
will
support
an
ongoing
e­
Cycling
Pilot
Project
of
EPA
Region
III's
Mid­
Atlantic
States,
which
is
promoting
reuse
and
recycling
of
electronics.
EPA
believes
that
today's
direct
final
rule
will
encourage
increased
recycling
and
better
management
of
these
materials
in
Region
III
states.
EPA
has
proposed
a
similar,
albeit
broader,
conditional
exclusion
for
CRTs
and
certain
other
electronic
materials
that
would
be
effective
nationwide
(
June
12,
2002,
67
FR
40508
 
40528).
EPA
is
promulgating
this
regional
rule
now
because
it
believes
that
implementing
the
rule
in
the
Region
III
states
will
produce
information
about
the
CRT
conditional
exclusion
that
will
be
useful
to
EPA
as
it
assesses
the
appropriateness
of
adopting
the
RCRA
exclusion
nationally.
EPA
expects
to
withdraw
the
regional
rule
if
and
when
a
final
national
rule
becomes
effective.
DATES:
This
direct
final
rule
is
effective
on
February
24,
2003
without
further
notice,
unless
EPA
receives
adverse
comment
by
January
27,
2003.
If
we
receive
such
comment,
EPA
will
publish
a
timely
withdrawal
in
the
Federal
Register
informing
the
public
that
this
rule
will
not
take
effect.
ADDRESSES:
Comments
may
be
submitted
by
mail
or
electronically.
Commenters
must
send
an
original
and
two
copies
of
their
comments
referencing
docket
number
III
 
02
 
OEI
 
01
to:
Marie
Holman
(
3EI00),
U.
S.
EPA
Region
III,
Office
of
Environmental
Innovation,
1650
Arch
Street,
Philadelphia,
PA
19103
 
2029
or
holman.
marie@
epa.
gov.
Further
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