Document ID: EPA-HQ-OPP-2002-0280-0001
Agency: epa
Document Type: Proposed Rule
Title: Pesticides; Minimal Risk Tolerance Exemptions
Posted Date: 2002-11-20T05:00Z

70036
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
may
result
in
estimated
costs
to
State,
local,
or
tribal
governments
in
the
aggregate;
or
to
the
private
sector,
of
$
100
million
or
more.
Under
section
205,
EPA
must
select
the
most
costeffective
and
least
burdensome
alternative
that
achieves
the
objectives
of
the
rule
and
is
consistent
with
statutory
requirements.
Section
203
requires
EPA
to
establish
a
plan
for
informing
and
advising
any
small
governments
that
may
be
significantly
or
uniquely
impacted
by
the
rule.
EPA
has
determined
that
the
proposed
action
does
not
include
a
Federal
mandate
that
may
result
in
estimated
costs
of
$
100
million
or
more
to
either
State,
local,
or
tribal
governments
in
the
aggregate,
or
to
the
private
sector.
This
proposed
Federal
action
acts
on
pre­
existing
requirements
under
State
or
local
law,
and
imposes
no
new
requirements.
Accordingly,
no
additional
costs
to
State,
local,
or
tribal
governments,
or
to
the
private
sector,
result
from
this
action.

H.
National
Technology
Transfer
and
Advancement
Act
Section
12
of
the
National
Technology
Transfer
and
Advancement
Act
(
NTTAA)
of
1995
requires
Federal
agencies
to
evaluate
existing
technical
standards
when
developing
a
new
regulation.
To
comply
with
NTTAA,
EPA
must
consider
and
use
``
voluntary
consensus
standards''
(
VCS)
if
available
and
applicable
when
developing
programs
and
policies
unless
doing
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
EPA
believes
that
VCS
are
inapplicable
to
today's
proposed
action
because
it
does
not
require
the
public
to
perform
activities
conducive
to
the
use
of
VCS.

List
of
Subjects
in
40
CFR
Part
52
Environmental
protection,
Air
pollution
control,
Intergovernmental
relations,
Nitrogen
oxides,
Ozone,
Particulate
matter,
Reporting
and
recordkeeping
requirements.

Authority:
42
U.
S.
C.
7401
et
seq.

Dated:
October
29,
2002.

Alexis
Strauss,

Acting
Regional
Administrator,
Region
IX.
[
FR
Doc.
02
 
29477
Filed
11
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
52
[
IN145
 
1b;
FRL
 
7398
 
6]

Approval
and
Promulgation
of
Implementation
Plans;
Indiana
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.

SUMMARY:
The
EPA
is
proposing
to
approve
revisions
to
particulate
matter
(
PM)
emissions
regulations
for
Union
Tank
Car
of
Lake
County,
Indiana.
The
Indiana
Department
of
Environmental
Management
(
IDEM)
submitted
the
revised
regulations
on
April
30,
2002
and
September
6,
2002
as
an
amendment
to
its
State
Implementation
Plan
(
SIP).
The
revisions
consist
of
relaxing
the
PM
limits
for
one
emissions
unit;
however,
actual
emissions
will
not
increase,
and
the
PM
National
Ambient
Air
Quality
Standards
(
NAAQS)
should
be
protected.
EPA
is
approving
revisions
for
Union
Tank
Car
because
complying
with
the
current
limits
is
infeasible,
and
because
the
revisions
should
not
harm
air
quality.
DATES:
The
EPA
must
receive
written
comments
on
this
proposed
rule
by
December
20,
2002.
ADDRESSES:
You
should
mail
written
comments
to:
J.
Elmer
Bortzer,
Chief,
Regulation
Development
Section,
Air
Programs
Branch
(
AR
 
18J),
U.
S.
Environmental
Protection
Agency,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604.
You
may
inspect
copies
of
Indiana's
submittal
at:
Regulation
Development
Section,
Air
Programs
Branch
(
AR
 
18J),
U.
S.
Environmental
Protection
Agency,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604.

FOR
FURTHER
INFORMATION
CONTACT:
Matt
Rau,
Environmental
Engineer,
Regulation
Development
Section,
Air
Programs
Branch
(
AR
 
18J),
U.
S.
Environmental
Protection
Agency,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604,
Telephone
Number:
(
312)
886
 
6524,
E­
Mail
Address:
rau.
matthew@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Table
of
Contents
I.
What
Action
Is
EPA
Taking
Today?
II.
Where
can
I
find
more
information
about
this
proposal
and
the
corresponding
direct
final
rule?

I.
What
Action
Is
EPA
Taking
Today?

The
EPA
is
proposing
to
approve
revisions
to
particulate
matter
emissions
regulations
for
Union
Tank
Car's
railcar
manufacturing
facility
in
Lake
County,
Indiana.
IDEM
submitted
the
revised
regulations
to
EPA
on
April
30,
2002
and
September
6,
2002
as
an
amendment
to
its
SIP.
The
revisions
consist
of
relaxing
the
limits
for
one
emissions
unit;
however,
actual
emissions
will
not
increase,
and
the
PM
NAAQS
should
be
protected.
EPA
is
proposing
approving
revisions
for
Union
Tank
Car
because
complying
with
the
current
limits
is
infeasible,
and
because
the
revisions
should
not
harm
air
quality.

II.
Where
Can
I
Find
More
Information
About
This
Proposal
and
the
Corresponding
Direct
Final
Rule?

For
additional
information
see
the
direct
final
rule
published
in
the
rules
section
of
this
Federal
Register.

Dated:
October
15,
2002.
David
A.
Ullrich,
Acting
Regional
Administrator,
Region
5.
[
FR
Doc.
02
 
29474
Filed
11
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0280;
FRL
 
7278
 
3]

Pesticides;
Minimal
Risk
Tolerance
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.

SUMMARY:
This
document
proposes
to
reorganize
certain
existing
tolerance
exemptions.
All
of
these
chemical
substances
were
reviewed
as
part
of
the
tolerance
reassessment
process
required
under
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
As
a
result
of
that
review,
certain
chemical
substances
are
now
classified
as
``
minimal
risk,''
and
are
therefore
being
shifted
to
the
section
of
40
CFR
part
180
that
holds
minimal
risk
chemical
substances.
The
Agency
is
merely
moving
certain
tolerance
exemptions
from
one
section
of
the
CFR
to
another
section:
No
tolerance
exemptions
are
lost
as
a
result
of
this
action.

DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0280,
must
be
received
on
or
before
January
21,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

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Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6304;
fax
number:
(
703)
305
 
0599;
e­
mail
address:
boyle.
kathryn@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
formulate
or
market
pesticide
products
or
if
you
market
certain
pesticides
that
have
been
exempted
from
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
pursuant
to
section
25(
b)
of
FIFRA.
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)
 
Antimicrobial
pesticides
(
NAICS
32561)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
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
 
0280.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
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Federal
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/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2002
 
0280.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2002
 
0280.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC,
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2002
 
0280.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2002
 
0280.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
A.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
your
estimate.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternatives.
7.
Make
sure
to
submit
your
comments
by
the
comment
period
deadline
identified.
8.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
response.
It
would
also
be
helpful
if
you
provided
the
name,
date,
and
Federal
Register
citation
related
to
your
comments.

II.
What
Action
is
the
Agency
Taking?

In
the
Federal
Register
published
on
May
24,
2002
(
67
FR
36534)
(
FRL
 
6834
 
8)
EPA
established
a
new
§
180.950
to
list
the
pesticide
chemical
substances
that
are
exempted
from
the
requirement
of
a
tolerance
based
on
the
Agency's
determination
that
these
chemical
substances
are
of
``
minimal
risk.''
As
the
first
step
in
populating
this
section,
the
Agency
shifted
the
existing
tolerance
exemptions
for
commonly
consumed
food
commodities,
animal
feed
items,
and
edible
fats
and
oils
to
this
section.
This
proposed
rule
shifts
existing
tolerance
exemptions
for
certain
inert
ingredients
that
have
been
classified
by
the
Agency
as
List
4A,
``
minimal
risk,''
to
40
CFR
180.950.
The
decision
documents
supporting
the
minimal
risk,
List
4A­
Classification,
are
in
the
docket.
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.2:
Citric
acid,
fumaric
acid,
lime,
sodium
chloride,
and
sulfur.
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.1001(
c):
Animal
glue;
bentonite;
calcareous
shale;
calcite;
calcium
carbonate;
calcium
citrate;
calcium
silicate;
a­
cellulose;
citric
acid;
coffee
grounds;
corn
dextrin;
dextrin;
dolomite;
graphite;
guar
gum;
gypsum;
hydroxyethyl
cellulose;
hydroxypropyl
methylcellulose;
iron
oxide;
kaolinitetype
clay;
lecithin;
licorice
root;
magnesium
carbonate;
magnesium­
lime;
magnesium
oxide;
magnesium
silicate;
magnesium
sulfate;
methylcellulose;
mica;
montmorillonite­
type
clay;
potassium
aluminum
silicate;
potassium
chloride;
potassium
citrate;
potassium
sulfate;
silica,
hydrated;
silicon
dioxide,
fumed,
amorphous;
sodium
acetate;
sodium
alginate;
sodium
aluminum
silicate;
sodium
bicarbonate;
sodium
carboxymethylcellulose;
sodium
chloride;
sodium
sulfate;
vermiculite;
xanthan
gum;
zeolite
(
hydrated
alkali
aluminum
silicate);
and
zinc
oxide.
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.1001(
d):
Cellulose
acetate;
graphite;
hydroxypropylcellulose;
locust
bean
gum;
paper
fiber,
deinked
or
recycled;
paper
fiber,
produced
by
the
kraft
(
sulfate)
or
sulfite
pulping
processes;
silicon
dioxide,
fumed,
amorphous;
soap
bark
(
quillaja);
sodium
citrate;
and
wool
fat
(
anhydrous
lanolin).
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.1001(
e):
Calcium
carbonate;
calcium
silicate
(
hydrated
calcium
silicate);
calcium
sulfate;
castor
oil,
u.
s.
p.;
a­
cellulose;
citric
acid;
dextrin;
graphite;
iron
oxide;
kaolinite­
type
clay;
magnesium
carbonate;
methylcellulose;
montmorillonite­
type
clay;
potassium
citrate;
silica,
amorphous,
fumed
(
crystalline
free);
silica,
hydrated
silica;
silica
aerogel;
sodium
carboxymethylcellulose,
sodium
sulfate;
sulfur;
xanthan
gum;
and
zinc
oxide.
The
following
tolerance
exemptions
are
also
being
shifted
from:
§
180.1036:
Hydrogenated
castor
oil,
§
180.1176:
Sodium
bicarbonate,
§
180.1177:
Potassium
bicarbonate,
and
§
180.1180:
Kaolin.
Because
this
action
merely
moves
certain
tolerance
exemptions
from
one
section
of
the
CFR
to
another
section,
it
will
have
no
substantive
or
procedural
effect
on
the
moved
tolerance
exemptions.
No
tolerance
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Proposed
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exemptions
are
lost
as
a
result
of
this
action.

III.
What
is
the
Agency's
Authority
for
Taking
this
Action?
This
proposed
rule
is
issued
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
(
Public
Law
104
 
170).
Section
408(
e)
of
FFDCA
authorizes
EPA
to
establish,
modify,
or
revoke
tolerances,
or
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
pesticide
chemical
substances
in
or
on
raw
agricultural
commodities
and
processed
foods.

IV.
What
is
``
Minimal
Risk?''
The
term
``
minimal
risk''
has
been
used
by
EPA
for
over
10
years,
and
has
generally
meant
List
4A
inert
ingredient
chemical
substances.
On
April
22,
1987
(
52
FR
13305),
EPA
created
a
series
of
four
lists
as
part
of
an
initiative
to
address
the
risks
potentially
posed
by
inert
ingredients
in
pesticide
products.
At
that
time
all
List
4
inert
ingredients
were
classified
as
``
inerts
of
minimal
concern.''
The
4A
Inert
Ingredient
List
was
created
on
November
22,
1989
(
54
FR
48314)
by
subdividing
List
4
into
Lists
4A
and
4B.
List
4B
inert
ingredients
are
``
inerts
for
which
EPA
has
sufficient
information
to
reasonably
conclude
that
the
current
use
pattern
in
pesticide
products
will
not
adversely
affect
public
health
or
the
environment.''
List
4A
inert
ingredients
are
``
minimal
risk
inert
ingredients.''
Only
substances
on
List
4A
are
permitted
to
be
used
as
inert
ingredients
in
certain
pesticides
that
have
been
exempted
from
FIFRA,
7
U.
S.
C.
136
et
seq.,
pursuant
to
section
25(
b)
of
FIFRA,
7
U.
S.
C.
136w(
b).
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.
Many
minimal
risk
or
List
4A
substances
are
naturally
occurring
substances
to
which
some
refinement
has
occurred,
such
as
beeswax,
limestone,
red
cedar
chips,
salt,
and
sugar.
The
determination
that
a
chemical
substance
is
minimal
risk
would
be
based
on
a
recognition
of
the
overall
safety
of
the
chemical
(
such
as
very
low
toxicity
or
practically
nontoxic
considering
the
widely
available
information
on
the
chemical
substances
known
properties,
and
a
history
of
safe
use
under
reasonable
circumstances.
Minimal
risk
(
List
4A)
chemical
substances
are
recognized
as
safe
for
use
in
all
pesticide
products
subject
only
to
good
agricultural
practices
or
good
manufacturing
practices.
Classification
as
a
List
4A,
minimal
risk,
chemical
substance
is
a
high
standard
to
meet.
As
an
example,
chemical
substances
of
high
acute
toxicity
are
usually
not
considered
for
classification
to
List
4A.
The
critical
distinction
between
List
4A
minimal
risk
chemical
substances
and
other
chemical
substances,
is
that
the
Agency
does
not
define
how,
where,
when
or
in
what
manner
the
chemical
substance
can
be
used.
Any
reasonably
foreseeable
use
of
these
chemical
substances
in
a
pesticide
product
is
not
expected
to
present
a
risk
to
humans.
Accordingly,
there
should
not
be
any
unreasonable
adverse
effects
from
the
inclusion
of
a
List
4A
chemical
substance
in
a
pesticide
product
to
the
person
applying
a
pesticide
product
in
and
around
their
home,
to
a
child
in
a
daycare
center,
or
when
ingesting
a
food
commodity
that
has
been
treated.
A
List
4A
chemical
substance
used
as
an
inert
ingredient,
incorporated
into
a
25(
b)
product
(
meeting
all
the
appropriate
exemption
criteria)
is
subject
to
no
Federal
regulation
under
FIFRA
except
as
provided
in
40
CFR
152.25(
g).
The
Agency
must
give
consideration
to
all
routes
of
exposure
to
determine
that
a
chemical
substance
used
in
a
pesticide
product
can
be
classified
as
minimal
risk.
Several
of
the
chemical
substances
being
shifted
to
the
new
section
are
naturally
occurring
materials
that
have
been
referred
to
as
weathered
materials.
Weathered
materials
is
the
term
that
the
Agency
is
using
to
describe
a
group
of
substances
that
could
also
be
referred
to
as
rocks
and
minerals.
Generally,
weathered
materials
are
decayed
or
weathered
rocks
that
are
mostly
unrefined,
i.
e.,
not
altered
or
manufactured
by
man.
When
referring
to
weathered
materials
as
mostly
unrefined,
the
Agency
is
including
the
mechanical
grinding
of
larger
rocks
into
smaller
pieces
that
are
essentially
the
same,
but
not
the
chemical
or
physical
alteration
of
the
rock
into
a
different
substance.
Naturally
occurring
materials
such
as
these
can
contain
impurities
such
as
asbestos
or
silica
which
can
lead
to
health
effects
including
pneumoconiosis,
silicosis,
or
kaolinosis.
To
evaluate
these
effects,
the
Agency
conducted
a
screening­
level
assessment
on
weathered
materials
that
compared
an
estimated
residential
exposure
to
the
OSHA
threshold
limit
value
(
TLV).
A
TLV
is
a
limit
on
inhalation
exposure
in
the
workplace.
Only
those
chemical
substances
that
passed
this
screening
level
assessment
were
considered
for
List
4A
status.
V.
Nomenclature
Changes
For
some
of
the
chemical
substances
that
are
being
shifted
to
40
CFR
180.950,
EPA
is
making
minor
changes
to
the
chemical
substance
names
that
were
previously
used.
Additionally,
the
Agency
has
attempted
to
identify
each
of
the
listed
chemical
substances
using
the
Chemical
Abstracts
Service
Registry
Number
(
CAS
No.).
The
CAS
No.
provides
one
of
the
most
distinct
and
universally
accepted
means
of
identifying
chemical
substances.
The
lack
of
a
CAS
No.
will
not
preclude
the
Agency
from
including
substances
in
40
CFR
180.950.
Generally,
there
will
be
only
one
CAS
No.
per
listed
substance;
however,
it
is
possible
that
more
than
one
CAS
No.
may
be
appropriate
for
some
substances,
such
as
when
there
is
both
a
hydrated
and
anhydrous
form.
EPA
has
both
broadened
and
consolidated
names
to
account
for
differing
terminologies
and
current
usage
status.
Also,
additional
information
to
better
define
the
impurities
in
some
naturally
occurring
substances
and
thus
limit
the
inhalation
concerns
that
can
occur
with
naturallyoccurring
materials
in
a
respirable
form
may
have
been
added.

VI.
Issues
for
Future
Agency
Actions
A.
Chemical
Substances
Being
Transferred
From
List
4A
to
List
4B
The
proposed
rule
published
in
the
Federal
Register
of
January
15,
2002
(
67
FR
1925)
(
FRL
 
6807
 
8)
indicated
that
several
allergen­
containing
food
commodities
would
be
moved
from
List
4A
to
List
4B.
The
Agency
has
now
determined
that
there
are
additional
chemical
substances
that
no
longer
meet
the
criteria
of
List
4A.
These
chemical
substances
are
acetic
acid,
activated
charcoal,
attapulgite
clay,
gum
arabic,
and
granite.
These
chemical
substances
will
be
transferred
from
the
Agency's
4A
list
to
the
4B
list.
Pesticide
products
containing
these
inert
ingredients
will
no
longer
be
considered
exempt
under
FIFRA
section
25(
b)
once
that
transfer
is
made.
Manufacturers
of
such
products
will
have
the
option
of
either
reformulating
their
product,
substituting
a
different
List
4A
inert
ingredient,
or
of
registering
the
product
with
the
Agency.
It
is
noted
that
vinegar
(
maximum
of
8%
acetic
acid
in
solution),
a
commonly
consumed
food
commodity,
is
still
classified
as
List
4A.

B.
Chemical
Substances
That
Have
Been
Classified
as
List
4A
The
Agency
has
classified
more
chemical
substances
as
List
4A,
and
is
likely
to
classify
additional
chemical
substances
as
List
4A.
Shifting
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/
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67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
existing
tolerance
exemptions
for
all
of
these
chemical
substances
to
40
CFR
180.950
is
a
multi­
step
process
that
will
continue.
Additionally,
on
its
own
initiative,
the
Agency
will
propose
to
establish
tolerance
exemptions
in
40
CFR
180.950
for
some
chemical
substances
that
are
currently
classified
as
List
4A,
but
do
not
have
tolerance
exemptions.
At
the
conclusion
of
this
multi­
step
process,
all
chemical
substances
classified
as
List
4A
will
be
included
in
40
CFR
180.950
and
will
thus
have
tolerance
exemptions.

VII.
Regulatory
Assessment
Requirements
This
proposed
rule
merely
reorganizes
existing
exemptions
in
40
CFR
part
180.
This
has
no
substantive
effect
and
hence
causes
no
impact.
The
Agency
is
acting
on
its
own
initiative
under
FFDCA
section
408
(
e)
in
shifting
these
existing
tolerance
exemptions
to
a
new
section.
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
subject
to
review
by
the
Office
of
Management
and
Budget
(
OMB).
Because
the
proposed
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
proposed
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
proposed
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
require
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).
Pursuant
to
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
these
proposed
actions
will
not
have
significant
negative
economic
impact
on
a
substantial
number
of
small
entities.
As
noted
in
this
unit,
this
action
will
have
no
substantive
or
procedural
effect
on
the
tolerance
exemptions
affected.
However,
by
grouping
tolerance
exemptions
that
have
qualified
as
minimal
risk
inerts
in
one
location
in
the
CFR,
this
action
will
make
it
easier
for
small
entities
to
efficiently
use
EPA's
tolerance
regulations.
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
proposed
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
proposed
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
proposed
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
proposed
rule.

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

Dated:
October
27,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Therefore,
it
is
proposed
that
40
CFR
chapter
I
be
amended
as
follows:

PART
180
 
[
AMENDED]

1.
The
authority
citation
for
part
180
would
continue
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
374.

§
180.2
[
Amended]

2.
In
§
180.2,
paragraph
(
a),
is
amended
by
removing
``
citric
acid,''
``
fumaric
acid,''
``
lime,''
``
sodium
chloride,''
and
``
sulfur.''

3.
In
§
180.950,
paragraph
(
e)
is
amended
by
alphabetically
adding
the
following
chemical
substances
to
read
as
follows:

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

*
*
*
*
*
(
e)
*
*
*

Chemical
substances
CAS
No.

Acetic
acid,
sodium
salt
.....................
127
 
09
 
3
Animal
glue
...........
None
Bentonite
...............
1302
 
78
 
9
Bentonite,
sodian
..
85049
 
30
 
5
Calcium
oxide
silicate
(
Ca3O(
SiO4))
.....
12168
 
85
 
3
Carbonic
acid,
calcium
salt,
(
limestone)
(
marble)
(
chalk)
(
mollusc/
bivalve
shells)
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
1317
 
65
 
3
Carbonic
acid,
calcium
salt
(
calcite)
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
13397
 
26
 
7
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Chemical
substances
CAS
No.

Carbonic
acid,
calcium
salt
(
1:
1),
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
471
 
34
 
1
Carbonic
acid,
calcium
salt
(
1:
1),
hexahydrate
......
15634
 
14
 
7
Carbonic
acid,
magnesium
salt
(
1:
1)
(
less
than
1%
crystalline
silica)
.................
546
 
93
 
0
Carbonic
acid,
monopotassium
salt
.....................
298
 
14
 
6
Carbonic
acid,
monosodium
salt
144
 
55
 
8
Carob
gum
(
locust
bean
gum)
.........
9000
 
40
 
2
Castor
oil
..............
8001
 
79
 
4
Castor
oil,
hydrogenated
.............
8001
 
78
 
3
Cellulose
...............
9004
 
34
 
6
Cellulose
acetate
..
9004
 
35
 
7
Cellulose,
carboxy
methyl
ether,
sodium
salt
............
9004
 
32
 
4
Cellulose,
2­
hydroxyethyl
ether
9004
 
62
 
0
Cellulose,
2­
hydroxypropyl
ether
..................
9004
 
64
 
2
Cellulose,
2­
hydroxypropyl
methyl
ester
......
9004
 
65
 
3
Cellulose,
methyl
ether
..................
9004
 
67
 
5
Cellulose,
mixture
with
cellulose
carboxymethyl
ether,
sodium
salt
.....................
51395
 
75
 
6
Cellulose,
pulp
......
65996
 
61
 
4
Cellulose,
regenerated
................
68442
 
85
 
3
Citric
acid
..............
77
 
92
 
9
Citric
acid,
calcium
salt
.....................
7693
 
13
 
2
Citric
acid,
calcium
salt
(
2:
3)
............
813
 
94
 
5
Citric
acid,
dipotassium
salt
3609
 
96
 
9
Citric
acid,
disodium
salt
............
144
 
33
 
2
Citric
acid,
monohydrate
.....
5949
 
29
 
1
Citric
acid,
monopotassium
salt
.....................
866
 
83
 
1
Citric
acid,
monosodium
salt
........
18996
 
35
 
5
Citric
acid,
potassium
salt
............
7778
 
49
 
6
Citric
acid,
sodium
salt
.....................
994
 
36
 
5
Citric
acid,
tripotassium
salt
866
 
84
 
2
Citric
acid,
tripotassium
salt
monohydrate
.....
6100
 
05
 
6
Chemical
substances
CAS
No.

Citric
acid,
trisodium
salt
........
68
 
04
 
2
Citric
acid,
trisodium
salt,
dihydrate
..............
6132
 
04
 
3
Citric
acid,
trisodium
salt,
pentahydrate
.....
6858
 
44
 
2
Coffee
grounds
.....
68916
 
18
 
7
Dextrins
.................
9004
 
53
 
9
Dolomite
(
CaMg(
CO3)
2)
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
16389
 
88
 
1
Feldspar
­
group
minerals
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
68476
 
25
 
5
Fuller's
earth
.........
8031
 
18
 
3
Fumaric
acid
.........
110
 
17
 
8
Graphite
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
7782
 
42
 
5
Guar
gum
..............
9000
 
30
 
0
Gypsum
(
sulfuric
acid,
calcium
salt,
dihydrate)
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
13397
 
24
 
5
Iron
oxide
(
FeO)
...
1345
 
25
 
1
Iron
oxide
(
Fe2O3)
1309
 
37
 
1
Iron
oxide
(
Fe2O3),
hydrate
..............
12259
 
21
 
1
Iron
oxide
(
Fe3O4)
1317
 
61
 
9
Kaolin
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
1332
 
58
 
7
*
*
*
*
*
Lanolin
..................
8006
 
54
 
0
Lecithins
................
8002
 
43
 
5
Lecithins,
soya
......
8030
 
76
 
0
Licorice
Extract
.....
68916
 
91
 
6
Lime
(
chemical)
dolomitic
(
magnesium
and
calcium
carbonate
(
magnesiumlime
..................
12001
 
27
 
3
Magnesium
oxide
1309
 
48
 
4
Magnesium
silicon
oxide
(
Mg2Si3O8)
14987
 
04
 
3
Maltodextrin
..........
9050
 
36
 
6
Mica
­
group
minerals
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
12001
 
26
 
2
Montmorillonite
.....
1318
 
93
 
0
Paper
....................
None
Perlite
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
130885
 
09
 
5
Chemical
substances
CAS
No.

Perlite,
expanded
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
93763
 
70
 
3
Plaster
of
Paris
(
sulfuric
acid,
calcium
salt,
hemihydrate);
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
26499
 
65
 
0
Potassium
chloride
7447
 
40
 
7
Silica
aerogel
........
Silica,
amorphous,
diatomaceous
earth
(
Kieselguhr)(
less
than1%
crystalline
silica)
......
61790
 
53
 
2
Silica,
amorphous,
fumed
(
crystalline
free)
112945
 
52
 
5
Silica,
amorphous,
perlite,
...............
Silica,
amorphous,
precipitated
and
gel
.....................
7699
 
41
 
4
Silica
(
crystallinefree
forms
only)
7631
 
86
 
9
Silica
gel
...............
63231
 
67
 
4
Silica
gel,
precipitated
crystalline
free
.........
112926
 
00
 
8
Silica,
hydrate
.......
10279
 
57
 
9
Silica,
vitreous
......
60676
 
86
 
0
Silicic
acid,
aluminum
potassium
salt
............
1327
 
44
 
2
Silicic
acid,
aluminum
salt
.........
1327
 
36
 
2
Silicic
acid,
aluminum
salt,
hydrate
..................
1335
 
30
 
4
Silicic
acid,
aluminum
sodium
salt
(
1:
1:
1)
.........
12003
 
51
 
9
Silicic
acid,
aluminum
sodium
salt
.....................
1344
 
00
 
9
Silicic
acid,
calcium
salt
.....................
1344
 
95
 
2
Silicic
acid,
calcium
salt,
(
wollastonite)
(
no
asbestos
and
less
than
1%
crystalline
silica)
13983
 
17
 
0
Silicic
acid,
magnesium
salt
............
1343
 
88
 
0
Silicic
acid,
magnesium
salt,
hydrate
..................
1343
 
90
 
4
Silicic
acid,
magnesium
salt
(
1:
1)
...
13776
 
74
 
4
Soapbark
(
Quillaja
saponin)
............
1393
 
03
 
9
Sodium
alginate
....
9005
 
38
 
3
Sodium
chloride
(
table
salt)
.........
7647
 
14
 
5
Sulfur
....................
7704
 
34
 
9
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20,
2002
/
Proposed
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Chemical
substances
CAS
No.

Sulfuric
acid,
calcium
salt
(
1:
1)
...
7778
 
18
 
9
Sulfuric
acid,
calcium
salt,
dihydrate
(
1:
1)
.........
10101
 
41
 
4
Sulfuric
acid,
calcium
salt,
hydrate
(
2:
2:
1)
......
10034
 
76
 
1
Sulfuric
acid,
magnesium
salt,
(
1:
1)
...................
7487
 
88
 
9
Sulfuric
acid,
magnesium
salt
(
1:
1)
heptahydrate
.....
10034
 
99
 
8
Sulfuric
acid,
magnesium
salt
(
1:
1)
monohydrate
.....
14168
 
73
 
1
Sulfuric
acid,
monopotassium
salt
.....................
7646
 
93
 
7
Sulfuric
acid,
dipotassium
salt
7778
 
80
 
5
Sulfuric
acid,
disodium
salt
............
7757
 
82
 
6
Sulfuric
acid,
disodium
salt,
decahydrate
..............
7727
 
73
 
3
Sulfuric
acid,
disodium
salt,
heptadydrate
.....
13472
 
39
 
4
Vermiculite
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
1318
 
00
 
9
Xanthan
gum
........
11138
 
66
 
2
Zeolites
(
excluding
erionite;
CAS
No.
12510
 
42
 
8)
.......................
1318
 
02
 
1
Zinc
oxide
.............
1314
 
13
 
2
§
180.1001
[
Amended]

4.
In
§
180.1001
the
table
in
paragraph
(
c)
is
amended
by
removing
the
following
entries:
``
Animal
glue;''
``
Bentonite;''
``
Calcareous
shale;''
``
Calcite;''
``
Calcium
carbonate;''
``
Calcium
citrate;''
``
Calcium
silicate;''
``
a­
Cellulose;''
``
Citric
acid;''
``
Coffee
grounds;''
``
Corn
dextrin;''
``
Dextrin;''
``
Dolomite;''
``
Graphite;''
``
Guar
gum;''
``
Gypsum;''
``
Hydroxyethyl
cellulose;''
``
Hydroxypropyl
methylcellulose;''
``
Iron
oxide;''
``
Kaolinite­
type
clay;''
``
Lecithin;''
``
Licorice
root;''
``
Magnesium
carbonate;''
``
Magnesiumlime
``
Magnesium
oxide;''
``
Magnesium
silicate;''
``
Magnesium
sulfate;''
``
Methylcellulose;''
``
Mica;''
``
Montmorillonite­
type
clay;''
``
Potassium
aluminum
silicate;''
``
Potassium
chloride;''
``
Potassium
citrate;''
``
Potassium
sulfate;''
``
Silica,
hydrated;''
``
Silicon
dioxide,
fumed,
amorphous;''
``
Sodium
acetate;
``
Sodium
alginate;''
``
Sodium
aluminum
silicate;''
``
Sodium
bicarbonate;''
``
Sodium
carboxymethylcellulose;''
``
Sodium
chloride;''
``
Sodium
sulfate;''
``
Vermiculite;''
``
Xanthan
Gum;''
``
Zeolite
(
hydrated
alkali
aluminum
silicate;''
``
Zinc
oxide.''
5.
In
§
180.1001
the
table
in
paragraph
(
d)
is
amended
by
removing
the
following
inert
ingredients:
``
Cellulose
acetate
(
CAS
Reg.
No.
9004
 
35
 
7),
minimum
number
average
molecular
weight,
28,000;
``
Graphite;''
``
Hydroxypropyl
cellulose;''
``
Locust
bean
gum;''
``
Paper
fiber,
deinked
or
recycled,
conforming
to
21
CFR
109.30(
a)(
9)
and
21
CFR
176.260;''
``
Paper
fiber,
produced
by
the
kraft
(
sulfate)
or
sulfite
pulping
processes;''
``
Silicon
dioxide,
fumed,
amorphous;''
``
Soap
bark
(
quillaja);''
``
Sodium
citrate;''
``
Wool
fat
(
anhydrous
lanolin).''
6.
In
§
180.1001
the
table
in
paragraph
(
e)
is
amended
by
removing
the
following
inert
ingredients:
``
Calcium
carbonate;''
Calcium
silicate
(
hydrated
calcium
silicate);''
Calcium
sulfate;''
``
Castor
oil,
U.
S.
P.;''
``
a­
Cellulose;''
``
Citric
acid;''
``
Dextrin
(
CAS
Reg.
No.
9004
 
53
 
9);''
``
Graphite;''
``
Iron
Oxide
(
CAS
Reg.
No.
1309
 
37
 
1);''
``
Kaolinitetype
clay;''
``
Magnesium
carbonate;''
``
Methylcellulose;''
``
Montmorillonitetype
clay;''
``
Potassium
citrate
(
CAS
Reg.
No.
866
 
84
 
2);''
``
Silica,
amorphous,
fumed
(
crystalline
free)
(
CAS
Reg.
No.
112945
 
52
 
5);''
``
Silica,
hydrated
silica,;''
``
Silica
aerogel
(
finely
powdered
microcellular
silica
foam
having
a
minimum
silica
content
of
89.5%);''
``
Sodium
carboxymethylcellulose;''
``
Sodium
sulfate;''
``
Sulfur
(
CAS
Reg.
No.
7704
 
34
 
9);''
``
Xanthan
gum;''
``
Zinc
oxide.''

§
180.1036
[
Removed]

7.
Section
180.1036
is
removed.

§
180.1176
[
Removed]

8.
Section
180.1176
is
removed.

§
180.1177
[
Removed]

9.
Section
180.1177
is
removed.

§
180.1180
[
Removed]

10.
Section
180.1180
is
removed.
[
FR
Doc.
02
 
29172
Filed
11
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
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31>
2002
16:
47
Nov
19,
2002
Jkt
200001
PO
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Frm
00014
Fmt
4702
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4702
E:\
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FM\
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