Document ID: EPA-HQ-OPP-2002-0280-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-10-02T04:00Z

1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
May
29,
2002
MEMORANDUM
FROM:
Kathryn
Boyle,
CoChair
IIFG
and
Kerry
Leifer,
CoChair
IIFG
TO:
Robert
Forrest,
Chief
Minor
Use,
Inerts,
and
Emergency
Response
Branch
SUBJECT:
IIFG
Decision
Memo
Please
find
attached
the
Inert
Ingredient
Focus
Group
recommendations
for
the
inert
ingredients
associated
with
cellulose
and
paper.
2
INERT
INGREDIENT
FOCUS
GROUP
DECISION
DOCUMENT
for
Cellulose
and
Paper
Petition
No.:
no
Tolerance
Reassessments?:
yes
Chemical
Substance
CAS
Reg.
No.
40
CFR
180.1001
citation
alpha
­
cellulose
(c)(
e)

croscarmellose
sodium
(a
cross­
linked
form
of
sodium
carboxymethyl
cellulose)
74811­
65­
7
(c)

sodium
carboxymethyl
cellulose
9004­
32­
4
(c)

Paper
fiber,
deinked
or
recycled,
conforming
to
21
CFR
109.30(
a)(
9)
and
21
CFR
176.260
(d)

Paper
fiber,
produced
by
the
kraft
(sulfate)
or
sulfite
pulping
processes.
(d)

Other
chemicals
considered
in
this
assessment
are:
methyl
cellulose,
hydroxyethyl
cellulose,
hydroxypropylmethyl
cellulose,
and
cellulose
acetate.
The
tolerance
exemptions
for
these
chemicals
have
been
previously
reassessed
and
are
included
in
this
assessment
only
for
their
structural
similarities
to
cellulose
and
to
consider
for
List
4A
classification.

HPV
Chemical?
No
Use
Pattern
(pesticidal):
Cellulose
can
be
used
as
a
solid
diluent,
carrier,
and
suspending
agent.
Cellulose
derivatives
are
used
as
suspending
agents,
surfactants,
thickeners,
and
dispersing
agents
in
food
and
cosmetics.
Cellulose
acetate
is
used
as
a
pesticide
rate
release
regulating
agent.
Paper
is
used
as
a
carrier.
3
Use
Pattern
(non­
pesticidal):
Cellulose
and
cellulose
derivatives
are
used
as
a
both
direct
and
indirect
food
additives.
As
direct
food
additives
they
are
used
in
baked
goods
and
baking
mixes,
fats
and
oils,
cheese,
meat
and
poultry
products,
sweet
sauces,
toppings,
syrups,
gelatins,
puddings
and
fillings,
gravies,
dairy
product
analogs,
candy
and
chewing
gum.
As
indirect
food
additives
they
are
used
as
substances
migrating
to
food
from
food
packaging.
The
cellulose
derivatives
are
used
in
cosmetics
such
as
hair
products,
eye
and
facial
makeup
and
skin
care
preparations.
They
can
also
be
used
in
surface
coatings,
as
polymerization
additives,
in
adhesives,
and
in
detergents
and
cleaners.
Croscarmellose
sodium
is
used
as
a
disintegrating
agent
in
pharmaceuticals
(tablets).
Cellulose
fibers
are
used
as
a
component
of
insulation.

1.
Introduction:

Cellulose,
or
alpha­
cellulose,
is
a
naturally­
occurring
polymeric
material.
It
can
also
be
referred
to
as
a
macromolecule
or
polysaccharide.
Chemically,
cellulose
is
a
long
chain
of
glucose
molecules
that
are
linked
with
beta
(1­
4)
glycosidic
bonds.
The
molecular
weight
of
isolated
cellulose
as
reported
by
FDA
is
approximately
50,
000
daltons.
Cellulose
is
part
of
the
plant
cell
wall
of
wood,
cotton,
and
various
plant
crops
consumed
for
nutrition.
It
is
the
most
abundant
carbohydrate
in
nature.
Dietary
cellulose
(i.
e.,
fiber)
from
edible
plants
is
consumed
by
humans
on
a
daily
basis.
Humans
do
not
possess
the
enzyme
necessary
to
break
the
beta
(1­
4)
glycosidic
bond;
thus,
cellulose
passes
unchanged
through
the
intestinal
tract.
The
Dietary
Guidelines
for
Americans
published
by
the
USDA
(United
States
Department
of
Agriculture)
recommend
eating
foods
with
adequate
fiber.
The
National
Cancer
Institute
recommends
that
an
individual
consume
20
to
30
grams
of
fiber
each
day
with
an
upper
limit
of
35
grams
per
day.

The
derivatives
are
not
naturally
occurring
materials,
but
are
manufactured
from
cellulose.
These
are
polymeric
substances
with
high
molecular
weights:
the
information
available
indicates
ranges
of
40,000
to
480,000
daltons
depending
on
the
degree
of
polymerization
Paper
is
manufactured
by
applying
a
watery
suspension
of
cellulose
fibers,
known
as
pulp,
to
a
screen
thus
allowing
the
water
to
drain
and
leaving
the
fibrous
particles
behind
in
a
sheet.
Pulp
is
produced
by
digesting
a
cellulose
containing
material
into
its
fibrous
constituents
via
chemical
and/
or
mechanical
means.
In
the
case
of
wood,
the
most
common
pulping
material,
chemical
pulping
actions
release
cellulose
fibers
by
selectively
destroying
the
chemical
bonds
in
the
glue­
like
substance
(lignin)
that
binds
the
fibers
together.
The
two
major
chemical
pulping
processes
used
in
the
US
are
kraft/
soda
pulping
and
sulfite
pulping.
Kraft
pulping
produced
80
percent
of
all
US
pulp
tonnage
during
1993.
After
the
pulping
process,
dependent
on
the
type
of
paper
desired,
paper
manufacturing
includes
various
processes
to
separate
and
remove
impurities,
bleaching
and
coloring
processes
to
achieve
the
desired
color,
adding
various
resins
or
texture
materials
depending
on
the
desired
end­
result,
and
drying
by
pressing
and
heating
to
bond
the
fibers.

The
following
information
was
used
in
performing
this
assessment:
The
available
information
consisted
of
information
retrieved
from
various
websites,
such
as,
4
°EPA(
www.
epa.
gov)
°
TOXNET
(
www.
toxnet.
nlm.
nih.
gov.)
°
World
Health
Organization
(WHO)
(jecfa.
ilsi.
org/
section1.
htm)
and
(www.
inchem.
org/
document/
jecfa/
jecmono/
v26je08.htm)

and
those
websites
containing
descriptions
of
cellulose
and
paper.

Additionally,
the
following
documents
were
used:
°
GRAS
(Generally
Recognized
as
Safe)
Food
Ingredients
­
Cellulose
and
Derivatives
were
evaluated
in
a
1972
assessment
by
FDA.
°
Certain
Cellulose
Derivatives
as
Food
Ingredients
were
evaluated
by
the
Food
and
Drug
Administration
(FDA)
in
a
1974
assessment.
°
Final
Report
on
the
Safety
Assessment
of
Hydroxypropylcellulose,
Hydroxypropylcellulose,
Methylcellulose,
Hydroxypropylmethylcellulose,
and
Cellulose
Gum:
Cosmetic
Ingredient
Review
Journal
of
the
American
College
of
Toxicology
Vol.
5
No.
3
(1986)

2.
Chemical
Specific
Uses
of
Cellulose
and
Cellulose
Derivatives:

Microcrystalline
cellulose
is
obtained
by
treating
alpha
cellulose
with
mineral
acids.
It
is
used
to
convert
liquid
foods
to
granular
forms
or
smooth­
spreading
gels,
and
as
an
anticaking
or
binding
agent.

Methyl
cellulose
is
used
as
a
thickener,
stabilizer,
emulsifier,
bodying
or
bulking
agent,
and
binder
in
foods.
It
was
first
used
in
foods
in
the
US
in
1960.

Carboxymethyl
cellulose
and
it
sodium
salt
(sodium
carboxymethyl
cellulose
or
cellulose,
carboxymethyl
ether,
sodium
salt
are
used
as
thickening
agents
and
stabilizers
in
foods.
Little
distinction
is
made
between
the
two
chemicals.
Both
were
first
used
in
foods
in
the
US
in
1945.

Hydroxypropylmethyl
cellulose
is
used
as
a
thickening
agent,
stabilizer,
and
emulsifier.

Ethyl
cellulose
is
used
as
a
coating
for
vitamin
preparations,
as
a
binder
and
filler,
and
as
a
component
of
paper
and
paperboard
food
packaging
materials.
It
is
in
hard
candy
and
chewing
gum.

3.
FDA's
Conclusions
There
is
a
large
toxicity
database
for
cellulose
and
its
derivatives.
It
includes
acute,
subchronic,
chronic/
carcinogenic,
and
reproductive
studies.
The
metabolism
and
absorption
has
been
well­
documented.

FDA's
overall
conclusion
is
as
follows:
5
"Cellulose
is
a
major
constituent
of
many
foods
of
plant
origin.
As
such
it
is
a
significant
portion
of
the
diet,
but
is
neither
degraded
nor
absorbed.
Cellulose
derivatives
considered
in
this
report
are
virtually
unabsorbed
and
little
or
no
degradation
of
absorbable
products
occurs
in
the
human
digestive
tract.
In
man,
consumption
of
large
amounts
appears
to
have
no
effect
other
than
providing
dietary
bulk,
reducing
the
nutritive
value
of
such
foodstuffs
and
possibly
exerting
a
laxative
effect."

FDA's
chemical­
specific
hazard
conclusions
are
as
follows:

Cellulose
and
Microcrystalline
Cellulose
"There
is
no
evidence
in
the
available
information
on
pure
and
regenerated
cellulose,
including
microcrystalline
cellulose,
that
demonstrates,
or
suggests
reasonable
grounds
to
suspect,
a
hazard
to
the
public
when
they
are
used
at
levels
that
are
now
current,
or
that
might
reasonably
be
expected
in
future."

Methyl
Cellulose
"In
humans,
virtually
100
percent
of
orally
ingested
methyl
cellulose
can
be
recovered
in
the
feces
within
four
days,
indicating
that
absorption
does
not
occur.
However,
in
pregnant
mice,
very
high
doses
of
methyl
cellulose,
while
not
teratogenic,
cause
a
significant
increase
in
maternal
mortality
and
retardation
of
fetal
maturation."

According
to
the
summary
of
the
study
in
the
FDA
Assessment
pregnant
rats,
hamsters,
and
mice
were
administered
doses
of
methyl
cellulose
in
corn
oil.
In
rats
at
doses
up
to
1320
mg/
kg/
day
for
10
consecutive
days,
there
was
no
clearly
discernible
effect
on
nidation
or
on
maternal
or
fetal
survival.
In
hamsters,
doses
of
up
to
1000
mg/
kg/
day
for
five
days
(gestation
days
6
to
10)
did
not
produce
significant
effects
on
nidation
(fertilization)
or
on
maternal
or
fetal
survival.

Daily
doses
of
up
to
345
mg/
kg/
day
from
day
6
through
day
15
of
gestation
in
mice
had
no
clearly
discernible
effect
on
nidation
or
on
maternal
or
fetal
survival.
However,
doses
of
1600
mg/
kg/
day
caused
a
significant
increase
in
mortality
in
treated
dams
and
a
decrease
in
the
pregnancy
rate
of
survivors.
There
was
a
marked
increase
in
the
number
of
resorption
sites.
The
live
fetuses
were
smaller
and
exhibited
significant
retardation
in
maturation.
The
findings
resembled
those
produced
by
high
molecular­
weight
polysaccharides
such
as
the
vegetable
gums.
The
dose
of
1600
mg/
kg/
day
is
higher
than
that
tested
in
either
the
rat
or
hamster.
It
is
possible
that
the
effects
could
be
due
to
nutritional
deficiencies
due
to
deliberately
high
doses
of
indigestible
material.

Information
in
the
FDA
assessment
indicated
that
the
average
daily
intake
for
cellulose
deliberately
added
to
foods
ranged
from
48
to
360
mg/
kg/
day
(1970s).
Cellulose
derivatives
were
at
significantly
lower
levels
and
ranged
from
less
than
1
to
36
mg/
kg/
day.
It
is
unlikely
that
levels
6
of
human
consumption
of
methyl
cellulose
would
reach
levels
comparable
to
those
at
which
effects
were
seen.

Carboxymethyl
Cellulose
and
Sodium
Carboxymethyl
Cellulose
"Because
carboxymethyl
cellulose
becomes
the
sodium
salt
in
the
presence
of
sodium
ion,
no
distinction
between
the
two
substances
as
used
in
food
need
be
made."
There
is
no
evidence
to
suggest
that
either
chemical
substance
would
be
a
hazard
to
the
public
when
used
at
levels
that
are
now
current
or
that
might
reasonably
be
expected
in
the
future."

Hydroxypropylmethyl
Cellulose
"There
is
no
evidence
in
the
available
information
on
hydroxypropylmethyl
cellulose
that
demonstrates,
or
suggests
reasonable
grounds
to
suspect,
a
hazard
to
the
public
when
it
is
used
at
levels
that
are
now
current
and
in
the
manner
now
practiced"
(thickening
agent,
stabilizer
and
emulsifier).
Given
the
nature
of
the
chemical
substance,
the
use
pattern
specified
above
as
a
food
additive
is
very
likely
to
also
be
the
use
pattern
for
pesticide
products."

Hydroxyethyl
Cellulose
In
the
FDA
assessment,
there
is
less
toxicity
information
available
for
hydroxyethyl
cellulose
than
for
other
cellulose
derivatives.
However,
given
the
chemical
similarities
of
the
derivatives,
there
is
no
reason
to
believe
that
this
cellulose
derivative
should
interact
with
the
human
body
with
any
significant
difference.
All
cellulose
derivatives
examined
are
of
low
toxicity;
therefore,
hydroxyethyl
cellulose
should
also
be
of
low
toxicity.

Cellulose
Acetate
In
the
FDA
Assessment,
cellulose
acetate
was
only
examined
for
use
as
a
food
packaging
material.
It
was
concluded
that:
"There
is
no
evidence
in
the
available
information
.....
that
demonstrates
or
suggests
reasonable
grounds
to
suspect,
a
hazard
to
the
public
when
.....
used
in
food
packaging
materials
as
now
practiced
or
as
they
might
be
expected
to
be
used
for
such
purposes
in
future."

TOXNET
indicated
that
cellulose
acetate
is
an
amorphous
white
solid
material
in
granular,
flake,
or
powder
form
from
which
fibers
can
be
formed
by
extrusion.
It
is
a
thermoplastic
material
and
can
be
heat­
set
or
extruded.
The
OSHA
(Occupational
Safety
and
Health
Administration)
Chemical
Sampling
Information
Form
contains
no
exposure
limits
or
health
factor
concerns.

The
establishment
of
the
tolerance
exemption
for
cellulose
acetate
in
1995
was
based
on
its
conformance
with
the
polymer
exemption
guidance
criteria.
7
4.
World
Health
Organization
(WHO)

Cellulose
derivatives
have
been
examined
at
eight
meetings
of
the
FAO/
WHO
Joint
Expert
Committee
on
Food
Additives
(JECFA).
Various
toxicological
studies
(acute,
chronic/
carcinogenic,
reproduction,
mutagenicity,
metabolism
and
absorption,
and
observations
in
man
were
discussed
for:
ethyl
cellulose,
ethyl
hydroxyethyl
cellulose,
hydroxypropyl
cellulose,
hydroxypropyl
methyl
cellulose,
methyl
cellulose,
methylethyl
cellulose,
and
sodium
carboxymethyl
cellulose.
The
human
observations
concerned
the
laxative
effects
of
modified
celluloses.

The
conclusion
was
reached
that
cellulose
derivatives
have
"a
low
toxicity."
The
estimate
of
acceptable
daily
intake
is
"not
specified",
which
is
defined
as:

A
term
applicable
to
a
food
substance
of
very
low
toxicity
which,
on
the
basis
of
the
available
data
(chemical,
biochemical,
toxicological,
and
other),
the
total
dietary
intake
of
the
substance
arising
from
its
use
at
the
levels
necessary
to
achieve
the
desired
effect
and
from
its
acceptable
background
in
food
does
not,
in
the
opinion
of
JECFA,
represent
a
hazard
to
health.
For
that
reason,
and
for
reasons
stated
in
individual
evaluations,
the
establishment
of
an
acceptable
daily
intake
expressed
in
numerical
form
is
not
deemed
necessary.
An
additive
meeting
this
criterion
must
be
used
within
the
bounds
of
good
manufacturing
practice,
i.
e.,
it
should
be
technologically
efficacious
and
should
be
used
at
the
lowest
level
necessary
to
achieve
this
effect,
it
should
not
conceal
inferior
food
quality
or
adulteration,
and
it
should
not
create
a
nutritional
imbalance
The
only
concern
specified
was
that
the
ability
to
produce
laxation
should
be
taken
into
account
when
using
these
substances
as
food
additives.

5.
SAR
Assessment
Several
of
the
cellulose
derivatives
were
evaluated
by
the
SAR
(structure
activity
relationship)
process.
Both
sodium
carboxymethyl
cellulose
and
ethyl
hydroxyethyl
cellulose
were
rated
as
low
concern
for
both
human
health
and
ecotoxicity
concerns.
Hydroxypropylmethyl
cellulose
and
methyl
cellulose
were
only
rated
for
human
health,
for
which
they
were
rated
as
low
concern.

6.
Paper
Assessment
The
tolerance
exemption
for
paper
was
established
on
April
14,
1988
(53
FR
12418)
(FRL­
3365­
8).
The
rationale
for
establishing
the
tolerance
exemption
included
its
similarities
to
other
cellulosic
materials
already
cleared
under
40
CFR
180.1001(
c),
and
the
fact
that
pulp
is
cleared
under
21
CFR
186.1673
as
an
indirect
food
substance
affirmed
as
generally
recognized
as
safe
(GRAS).
8
The
Agency
no
longer
uses
comparisons
to
similar
materials
as
the
basis
for
action
unless
the
materials
have
already
undergone
the
tolerance
reassessment
process
and
have
been
determined
to
be
reassessed.
In
this
case,
the
similar
materials
alpha­
cellulose,
oat
hulls,
shells
(almond,
cocoa,
coconut,
and
walnut),
and
wood
flour
have
already
been
reassessed,
or
in
the
case
of
alpha­
cellulose
is
being
reassessed
in
this
document.
As
explained
previously
paper
is
mostly
cellulose
fibers.
Paper
is
derived
from
pulp.
Pulp
is
derived
mostly
from
wood.

The
tolerance
exemption
for
de­
inked
and/
or
recycled
paper
was
established
on
August
1,
1989
(54
FR
31674)
(FRL­
3623­
5).
Paper
that
is
to
be
recycled
must
first
be
de­
inked,
that
is,
the
ink
as
well
as
the
various
coatings
and
additives
are
separated
from
the
fibers
(such
as
cellulose)
that
form
the
structure
of
paper.
It
is
the
cellulose
fibers
that
are
recycled.
These
fibers
are
then
combined
with
fibers
that
have
not
been
previously
made
into
paper.

The
rationale
for
establishing
the
de­
inked
and/
or
recycled
tolerance
exemption
included
the
above
tolerance
exemption
for
paper,
and
the
fact
that
pulp
from
reclaimed
paper
is
cleared
under
21
CFR
176.260
as
a
component
of
articles
used
in
producing,
processing,
preparing,
treating,
packaging,
transporting,
or
holding
food
subject
to
certain
provisions.

It
is
not
expected
that
residues
of
paper
when
used
as
a
carrier
(the
use
that
would
be
expected
due
to
the
nature
of
paper)
would
be
present
in
raw
agricultural
commodities.
When
applied
to
crops,
paper
would
not
be
expected
to
be
absorbed
by
the
plant.

7.
Croscarmellose
Sodium
Croscarmellose
sodium
is
a
cross­
linked
carboxymethylcellulose
sodium
that
is
sometimes
referred
to
as
sodium
cellulose
glycolate.
The
cross­
linking
reduces
its
water
solubility
and
permits
the
material
to
swell
and
take
up
many
times
its
weight
in
water.
These
properties
make
croscarmellose
sodium
similar
to
those
of
sodium
starch
glycolate,
a
cross­
linked
potato
starch
derivative.
Sodium
starch
glycolate
is
produced
by
crossing­
linking
and
carboxymethylation
of
potato
starch.
Both
chemicals
are
used
as
disintegrants
(disintegrating
agents)
in
the
pharmaceutical
industry.

The
only
concern
for
either
of
these
chemicals
would
be
for
inhalation
of
respirable
particles
(less
than
10
microns).
Since
either
of
these
materials
can
absorb
many
times
their
own
weight
in
water
and
swell
(in
volume),
inhalation
of
respirable
particles
may
lead
to
lung
effects.
However,
these
concerns
can
be
addressed
by
the
acute
end­
product
toxicity
testing
performed
at
the
time
of
product
registration.

8.
Hazard
Characterization:

Other
than
the
inhalation
concerns
for
croscarmellose
sodium,
there
is
no
available
information
on
any
of
the
chemicals
considered
in
this
document
indicative
of
a
hazard
or
significant
adverse
effects
­
to
the
general
public
or
any
population
subgroup.
There
have
been
9
many
reviews
of
these
materials
by
organizations
such
as
FDA
and
WHO.
The
available
information
indicate
that
these
chemical
substances
pass
through
the
intestinal
tract
unabsorbed.
They
are
of
low
toxicity.

9.
Type
of
risk
assessment:
qualitative
10.
Sensitivity
of
Infants
and
Children:

These
chemicals
have
low
toxic
potential.
In
addition,
humans
of
all
ages
are
highly
exposed
to
them
from
natural
and
anthropogenic
sources.
At
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children.
A
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

11.
Fate
Assessment:

Cellulose
derivatives
would
undergo
biological
degradation
in
a
matter
of
days
to
weeks,
and
ultimate
degradation
to
carbon
dioxide
and
water
in
a
matter
of
weeks
to
months.
In
water,
partitioning
to
the
sediment
is
likely;
therefore,
celluloses
would
be
expected
to
be
found
in
the
sorbed
state
in
water.
Transport
to
surface
in
the
sorbed
state
would
dominate
the
nondegradation
pathways
of
dissipation.
Groundwater
contamination
is
not
likely
to
be
significant,
given
the
partitioning
to
the
sediment.

12.
Ecotoxicity
Assessment
Cellulose
derivatives
would
be
practically
non­
toxic
to
aquatic
organisms.
Terrestrial
animal
toxicity
based
on
the
available
data
would
indicate
cellulose
derivatives
are
practically
nontoxic
on
an
acute
basis.

13.
Cumulative
Exposure:

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."
Cellulose
and
its
derivatives
are
structurally
related;
however,
all
are
low
toxicity
chemicals.
Therefore,
the
resultant
risks
separately
and/
or
combined
should
also
be
low.
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
these
chemicals
have
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.

14.
IIFG
Recommendations:

By
consensus
there
were
no
objections
to
the
following:
10
The
following
tolerance
exemptions
are
reassessed:
In
40
CFR
180.1001
(c)
alpha
cellulose,
croscarmellose
sodium,
and
sodium
carboxymethylcellulose.
In
40
CFR
180.1001
(d)
Paper
fiber,
deinked
or
recycled,
conforming
to
21
CFR
109.30(
a)(
9)
and
21
CFR
176.260,
and
Paper
fiber,
produced
by
the
kraft
(sulfate)
or
sulfite
pulping
processes.
In
40
CFR
180.1001
(e)
alpha­
cellulose.

Given
the
non­
toxic
nature
of
cellulose
and
its
derivatives,
the
following
List
reclassifications
are
made
or
confirmed:

cellulose
(CAS
Reg.
No.
9004­
34­
6,
65996­
61­
4):
List
4A
cellulose
acetate
(CAS
Reg.
No.
9004­
35­
7:
List
4A
carboxymethyl
cellulose
(CAS
Reg.
No.
9000­
11­
7):
List
4A
hydroxypropylmethyl
cellulose
(CAS
Reg.
No.
9004­
65­
3):
List
4A
methyl
cellulose
(CAS
Reg.
No.
9004­
67­
5):
List
4A
sodium
carboxymethyl
cellulose
(CAS
Reg.
No.
9004­
32­
4,
51395­
75­
6):
List
4A
Given
the
derivation
of
paper
from
cellulose,
the
history
and
nature
of
paper,
and
the
role
that
it
plays
in
our
daily
lives,
the
List
4A
reclassifications
are
reconfirmed
for
paper.

Croscarmellose
sodium
is
classified
as
List
4B,
due
to
the
inhalation
concerns.

Tolerance
exemptions
(with
List
4A
classification)
may
be
established
for:

ethyl
cellulose
(CAS
Reg.
No.
9004­
57­
3)
hydroxyethyl
cellulose
(CAS
Reg.
No.
9004­
62­
0)
cellulose,
regenerated
(CAS
Reg.
No.
68442­
85­
3)
hydroxypropyl
cellulose
(CAS
Reg.
No.
9004­
64­
2).
ethyl
hydroxyethyl
cellulose
(CAS
Reg.
No.
9004­
58­
4)

Attachment:

EFED
review
(Abel;
April
10,
2002)