Glass Fiber Contamination of Cigarette Filters: An Additional Health

advertisement
Vol.
7. 96 7-979.
November
Glass
Fiber
John L. Pauly,2 Hans
K. Michael
Cummings,
Richard
J. Streck
Department
Microscopy
Epidemiology
York State
of Molecular
Ultrastructure
[K. M. C.],
Department
of
Abstract
We report
here
contamination
labeled
Eclipse
(RJR),
with
of Cigarette
Filters:
Risk to the Smoker?’
glass
documenting
smoking
the
article
fragments,
and particles.
Tobacco
was commercialized
in June of 1996.
of the
Biomarkers
An Additional
& Prevention
Health
99%
Immunology
[J. L. P., H. J. L., J. D. L., R. J. S.],
Facility
[E. L. H.], Cancer
Control
and
Roswell
Park Cancer
Institute
(a unit of the New
Health),
Buffalo,
New York 14263
of studies
Epidemiology,
118/120, 98%; Menthol,
n
120/120,
100%).
Likewise,
of NEW Eclipse had glass fibers on the redesigned
filter (Regular,
n = 119/120).
In contrast,
glass fibers
were never observed
on the filters of conventional
United
States
filter cigarettes
that had been used as controls
(n
0/120, 0%). In a study of Eclipse (n = 60), the
number
of glass fibers contaminating
the filter surface
ranged
from S to 55. Glass fibers as well as fiber fracture
items
[aspect ratio, <3:1 (e.g., particles,
fragments,
bits,
chips,
flakes, specks, and dust)] were discovered
in the
pack residue. The average number
of glass fibers in the
residue
of a pack of Eclipse
was 7,548 (SE ± 3443;
range,
1,164 to 26,725 glass fibers/pack;
n
7 packs).
The thin
and fragile glass fibers of the insulation
mats had most
J. Lee, Edward
L. Hurley,
Joel D. Lesses, and
the results
a product
Company
Contamination
of a cigarette-appearing
Eclipse
Eclipse,
Cancer
1998
fibers,
R. J. Reynolds
likely
is unlike
been
conventional
cigarettes
in that, like its
predecessor
Premier,
it is designed
to heat and not burn
tobacco.
The purpose
of Eclipse was to simplify
the
chemical
composition
and reduce
the biological
activity
of
multiple-step
the mainstream
and sidestream
smoke and to achieve a
significant
reduction
of environmental
tobacco smoke. In
Eclipse,
tobacco pyrolysis
is reduced
by a carbon fuel rod
that serves as a heat source
for generating
an aerosol
having nicotine
and tobacco flavor. The carbon rod, at
the tip of the cigarette,
is insulated
and bound with two
wrapping
mats of glass fibers. Recently,
Eclipse has been
modified
to address consumer
complaints
of burdensome
draw
and off-taste.
The redesigned
Eclipse, which we
have termed the NEW Eclipse,
has an unconventional
filter-appearing
mouthpiece
that consists
of a cellulose
acetate cylindrical
bundle with a central hollow tunnel. In
our analysis
of Eclipse, glass fibers (length:width
aspect
ratio, 3:1)
were: (a) observed
protruding
from the tip;
(b) identified
on the white cigarette
wrapping
paper; (c)
viewed on the surface of the cork-appearing
tipping
paper; (d) found in the pack residue;
(e) discovered
lying
freely
on the cut surface of the filter by both light and
electron
microscopy;
(J) harvested from the filter with
adhesive
tape; and (g) displaced
when Eclipse was
smoked
mechanically.
In a study of Eclipse that had not
been removed
from carefully
opened packs, we observed
that 95%
of the filters were contaminated
with glass
fibers
(Eclipse:
Regular,
n
114/120, 95%; Muds, n
microscopic
Received
6/26/97;
revised
7/20/98;
accepted
7/27/98.
The costs of publication
of this article
were defrayed
in part by the payment
page charges.
This article
must
therefore
be hereby
marked
advertisement
accordance
with 18 U.S.C.
Section
1734 solely
to indicate
this fact.
of
in
I Supported
in part by NiH Grants
CA-67827
and Roswell
Park Cancer
Institute
Cancer
Center
Core Grant
P30 CA16056.
2 To whom
requests
for reprints
should
be addressed,
at Department
of Immunology, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY
14263.
Phone:
(716) 845-8538:
Fax: (716) 845-8906:
E-mail:
pauly@SC3102.
med.buffalo.edu.
broken
and
Eclipse
fragmented
Invariably,
puffing
on Eclipse
glass particles
from the filter
Subsequently,
the bioresistant
glass
in the
manufacturing
dust
high-speed
operation.
discharged
glass
fibers
into the smoker’s
glass
are inhaled
Contamination
of Eclipse
filters
glass dust poses a potential
and
fibers
and/or
with
and
mouth.
and
ingested.
glass
fibers
and
unnecessary
health
hazard to uninformed
consumers.
Eclipse is a paradigm
of the health danger that may be imposed
by technically
complex
tobacco articles and nicotine delivery
devices
promoted
by an unregulated
industry
to smokers
worldwide,
many of whom are addicted
to nicotine
and
who seek a less hazardous
cigarette.
Introduction
In 1987,
RJR3 announced
Premier,
and a market
test was
conducted from October 1988 through
February
1989 (1-4).
Premier
was one of several
smoking
articles
defined
by RJR as
“NEW
CIGARETTE
Prototypes
That Heat Instead
Of Burn
Tobacco”
(1-1 1). The stated objectives
of these cigarette-appealing
devices,
as set forth in an RJR monograph
(10), were
to: (a) simplify
the chemical
composition
of mainstream
and
sidestream
smoke
emitted
by the “NEW
CIGARETTE”
(10);
(b) minimize
the biological
activity
of the mainstream
and
sidestream
smoke
emitted
by the NEW CIGARETTE:
and (c)
achieve
significant
reduction
of environmental
tobacco
smoke
from the NEW CIGARETTE
(see also RJR reports,
Refs. 6, 12,
and 13).
The performance
of Premier
in the market
evaluation
was
poor (2-5,
7, 8, 1 1 ). Smokers
rejected
Premier
because
of
off-taste,
difficulty
in lighting,
and other problems
(2-5,
7, 8,
1 1), Premier
was reconfigured
to address
these shortcomings
3
The
abbreviations
used
are:
scanning electron microscopy:
analysis:
carbon.
NTP,
National
RJR,
R. J. Reynolds
Tobacco
Company:
SEM/EDX,
SEM energy
dispersive
X-ray
Toxicology
Program:
PAH. polycyclic
aromatic
SEM.
microhydro-
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
967
968
Eclipse
Contaminated
with
Glass
Fibers
7,
8, 1 1). After
3 years
of development,
Eclipse
was
introduced
(2-5,
7, 8, 1 1). Features
of Premier
and Eclipse have
been described
in more than 20 U. S. Patents
(9, 10), and patent
protection
has been sought
in more than 1 10 countries
(10).
In June of 1996, Eclipse
began selling in Chattanooga,
TN
(1, 3). Soon thereafter,
the market
test was expanded.
In 1998,
Eclipse
is being sold in other United
States cities. Additionally,
Eclipse
is being sold in different
countries
under various
trade
names
(Ref. 1 ; see “Materials
and Methods”).
In September
of
1997, RJR introduced
a modified
version
ofEclipse
to Lincoln,
NE ($2.69
per pack, including
tax; Ref. 14). We have designated
the neengineered
Eclipse
as the NEW
Eclipse.
When
compared
with the original
Eclipse,
significant
changes
in the
NEW Eclipse
included:
(a) improved
lighting;
(b) filter modification;
(c) more tobacco
taste; and (d) 80% less secondhand
smoke;
the corresponding
value cited by RJR for the original
Eclipse
was 90% (14).
Eclipse
has the outward
appearance
and geometry
of a
conventional
cigarette
(Refs.
1, 3, 4, 9, and 10; Fig. 1) and is
obtainable
in four king-size
styles:
Regular,
Milds,
Menthol,
and Menthol
Milds (1, 3).
Opening
Eclipse
with a razor (Fig. I) revealed
that it is a
multiple
component,
technically
sophisticated
smoking
device
having many items not found in conventional
cigarettes
(1-5,
7,
9). Essential
to the design
of both Premier
and Eclipse
was the
goal that tobacco
pyrolysis
was to be reduced
greatly
(6, 10).
This was accomplished
with the use of a carbon
fuel nod (Refs.
1, 3, 4, and 6-10;
Figs. 1 and 2, a and b) that, when ignited,
would
heat reconstituted
tobacco
to generate
a low-smoke
nicotine
containing
aerosol
that imparts
a tobacco
taste (1, 3, 4,
7, 9, 10).
Unlike
a conventional
cigarette,
Eclipse
does not burn
down to the filter when smoked;
the spent Eclipse
retains
its
length
(Fig.
1; Refs. 4, 9, and 10). When
smoked,
Eclipse
displays
an ash-appearing
tip that consists
mostly
of an insulation mat of glass fibers (Fig. 1 ; Refs. 1 , 4, 9, and 10). Eclipse
burns
very little paper,
which,
in conventional
cigarettes,
is
impregnated
with burn accelerators
and smoke
modifiers
(Fig.
1; Refs.
10 and 15). The burning
(-900#{176}C; Refs. 4 and 10)
carbon
nod is insulated
with two glass fiber mats (Fig. 1 ; Refs.
4, 9, and 10). The primary
function
of the glass mats is to: (a)
secure
the position
of the carbon
fuel rod; (b) insulate
the
burning
rod; and (c) direct the heat from the rod to the adjacent
tobacco
column
(10). Other components
of Eclipse
have been
described
in detail elsewhere
(9, 10).
The Eclipse
filter resembles
that of a conventional
cigarette; however,
the filter nod has been truncated
and is approximately
one-third
the length
(Fig. 1; Refs. 3, 9, and 1 5). The
filter rod of conventional
cigarettes
consists
of thousands
of
Y-shaped
cellulose
acetate
fibers (Ref.
16; see also Ref. 15).
Y-shapcd
cellulose
acetate
fibers that are similar
in appearance
are used in the filters of Eclipse
and NEW Eclipse.
Observations
obtained
in our initial inspection
of Eclipse
raised
concern
that the thin and fragile
glass
fibers
of the
insulation
mats may break during
manufacturing
and contammate the surface.
To address
this hypothesis,
a study
was
conducted
to: (a) determine
whether
the glass fibers and partides are present
in the pack residue
and the surface
of Eclipse;
and (b) if present,
is there evidence
to assume
with reasonable
certainty
that the glass fibers would
be inhaled
and/or ingested
when Eclipse
is smoked
as intended.
The rationale
for undertaking
these studies
is derived
in part from animal
and human
studies
that have for many years addressed
the health
risks of
inhaled
glass fibers;
in evaluating
these findings,
it was concluded
in 1994 that: “From
our comprehensive
review
of the
(2-5,
available
information,
are carcinogenic.
.
Materials
and
.
“
we conclude
(17).
that
fibrous
glass
materials
Methods
Eclipse,
NEW
Eclipse,
and
Conventional
Cigarettes.
Eclipse
from RJR was the test article of this study. The Regular,
Milds and Menthol
Eclipse
articles
were purchased
from 1996
through
1997 from retail
vendors
in Chattanooga,
TN. The
NEW Eclipse
articles
were bought
from retail stores in Lincoln,
NE and Chattanooga,
TN; these were procured
in 1998. We
analyzed
also Eclipse
that had been licensed
by RJR for sale in
Sweden
(Inside,
Regular,
and Menthol;
Svenska
Tobaks,
AB,
Stockholm,
Sweden),
and in Germany
(HiQ, Regular;
German
subsidiary
of RJR).4
Premier
smoking
articles
from RJR were
provided
by colleagues
who had purchased
them during
the test
market
period
from retail dealers.
Conventional
United
States
filter cigarettes
were used as controls.
The conventional
cigarettes
were of different:
(a) brands
(e.g.,
premium
and discount);
(b) manufacturers
(e.g.,
RJR and other United
States
tobacco
companies);
(c) styles
(e.g.,
Regular,
Mild, and Menthol); and (‘0 packaging
(e.g.,
hard and soft pack). All had been
purchased
from retail merchants
in Erie County,
NY.
Inspection
of Eclipse
and Conventional
Cigarettes.
Packs of
Eclipse
and conventional
cigarettes
were opened
carefully
in
the laboratory
and by personnel
familiar
with the purpose
and
scope of our investigation.
Safeguards
were used to protect
both
Eclipse
and conventional
cigarettes
from airborne
fiber and
particle
contaminants.
A partial
listing of the precautions
used
are as follows: (a) after unwrapping
and discarding
the cellophane film, the flip-top
lid was reflected
and taped to maintain
the pack in an open position.
The front aluminum
foil was lifted
off carefully
and discarded.
The back aluminum
foil was removed
by cutting
with clean scissors.
All manipulations
were
performed
without
contacting
or moving
the Eclipse.
Particular
care was exercised
in not touching
the filter, the major test site
of this study;
(b) Eclipse
articles
were examined
immediately
after opening
the package
so as to reduce the exposure
and risk
to contaminants;
(c) the filters
were inspected
for glass fibers
without
removing
the Eclipse
or conventional
cigarettes
from
the pack. After inspection
of the filters for glass fiber contaminants,
the top was closed,
and the pack
was stored
in a
stationary
upright
position
in a closed
plastic
container;
(d)
conventional
cigarettes,
which
had been handled
in a similar
manner,
were used as assay controls;
(e) for some
tests, the
Eclipse
and conventional
cigarettes
were taken out of the pack.
In these assays,
examinations
for glass fibers and particles
were
conducted
immediately
after removing
the Eclipse
and conventional cigarettes;
and (f) samples
for SEM or SEM/EDX
were
transported
and stored in closed
boxes and examined
immediately after removing.
Examination
of the Tip of Eclipse.
The tip of Eclipse
was
inspected
to assess the integrity
of the two glass fiber insulation
mats. For this evaluation,
a pack was inverted,
and the paperboard was cut carefully
from the bottom
of a pack with scissors
(Fig. 2) without
contacting
or disturbing
the Eclipse
articles.
The tip was scrutinized
with a stereo-zoom
microscope.
After
completing
the microscopic
examination
of the glass mats and
carbon
rod, the Eclipse
articles
were removed
carefully
and
individually
with forceps
from
the pack
and positioned
at
Eclipse
is also
our study.
4
marketed
in Japan
(AIRS);
however,
AIRS
was
not available
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
for
Cancer
Epidemiology,
Biomarkers
& Prevention
969
0
Fig. 1.
Upper
Components
of
panel,
nonsmoked
Eclipse.
Eclipse;
middle
panel,
Eclipse
after
being
completely
smoked;
lower
panel,
nonsmoked
Eclipse
that has been cut
open to illustrate:
a, carbon
fuel rod;
b, insulation
mats of glass fibers;
c,
tobacco
paper;
d, column
wrapping
of white paper with an interior
lammate aluminum
foil heat barrier;
e,
distal column
of reconstituted
tobacco; f proximal
column
of reconstituted tobacco;
g, tipping
paper with
a cork-like
appearance;
h, lasergenerated
holes for side-stream
ventilation
and smoke dilution
(we have
enlarged
the size of the holes to facilitate
viewing
their
position
and
number);
and i, filter
of cellulose
acetate
fibers.
Eclipse
length,
83
mm.
‘
w
54
0
.
I
o;a
different
angles so as to permit
the tip at different
perspectives.
critical
microscopic
viewing
of
Analysis
of the Pack Residue
for Glass Fibers
and Particles.
The debris
at the bottom
of the pack of Eclipse
and conventional cigarettes
was examined
for glass fibers,
particles,
and
fragments.
In this investigation,
the top of the pack was opened,
and all of the Eclipse
articles
were removed.
Then, the pack was
inverted,
and the residue
was tapped
from the pack directly
into
a cartridge
that is marketed
to analytical
laboratories
for the
quantitative
analysis
of airborne
fibers
and particles
(Zefon,
Inc., St. Petersburg,
FL). We selected
a standard
cartridge
that
had been preloaded
with a 25-mm
diameter
micropore
(0.45m) membrane.
The plastic
disposable
cartridge
was clamped
in an upright
position
to a vertical
pole of a laboratory
stand that
had been placed
in a laminar
flow hood.
Afterward,
the protective
seal was removed,
and the cartridge
was opened.
Then,
the aluminum
foil liner of the cigarette
package
was extracted
and flushed
thoroughly
with a stream
of fiber-free
water that
was directed
into the cartridge.
The pack residue
sample
that
had been transferred
to the assay cartridge
was then deposited
gently
onto the membrane
by low-vacuum
filtration.
During
this step, the cartridge
walls were rinsed
thoroughly
with a
stream of hospital
grade water. Thereafter,
the micropore
membrane was removed
and dried at 56#{176}C
in a covered
plastic Petri
dish.
After placing
the membrane
onto a clean glass slide, the
disc was cleared,
and a coverglass
was mounted
using Cytoseal
60 (Stevens
Scientific,
Riverdale,
NJ). The number
of glass
fibers
was determined
by inspecting
the membrane
with a
microscope
that had been configured
for viewing
with white,
polarizing,
and phase-contrast
lighting
as well as epifluorescent
lighting
with different
filter
configurations.
The number
of
glass fibers in each of five microscopic
fields (X 10 objective)
of each membrane
was counted
and recorded.
The mean number per field and the viewing
field area were then used to
calculate
the total number
of glass fibers
in the residue
of a
pack.
Controls
consisted
of micropore
membranes
that had been
0
0
0
processed
in the same manner
but which contained
either:
(a)
no pack residue
(i.e.,
microscope
slide and micropore
membrane control);
or (b) residue
from packs of control
cigarettes.
For nonquantitative
morphological
and chemical
analysis,
the
residue
was collected
directly
(e.g. , no water,
no membrane,
no
dry ing, and no mounting)
onto a glass microscope
slide or SEM
stub (see below).
Fibers,
defined
by the National
Toxicology
Program
(United
States
Department
of Health
and Human
Services),
were recognized
as structures
having
a length:diameter
aspect
ratio of 3: 1 or greater
( 18). Glass structures
having
an aspect
ratio of <3: 1 were defined
as particles;
the term particle
is used
herein
as a generic
term that includes
other descriptive
expressions including
fragments,
flakes,
bits, chips, specks,
and dust.
In identifying
glass fibers
and particles
by polarized
microscopy, we used protocols
and schema
used routinely
for fiber
identification
by forensic
scientists
( 19). Unlike
all other fibers
and particles,
glass items do not polarize
light; this is defined
as
isotropic
(19). This unique
optical
property,
transparency,
size
[i.e.,
diameter(s)],
cross-sectional
shape,
surface
morphology,
color,
terminus
(i.e. , end)
appearance,
and other
optical
and
morphological
characteristics
were used to distinguish
Eclipsederived
glass fibers and glass particles
from other items found
in the pack residue.
Filter
Tipping Paper Tested for Glass Fibers.
The surface of
the cork-appearing
tipping
paper of Eclipse
and conventional
cigarettes
was tested for glass fibers. For this purpose,
the filter
was rolled
one complete
rotation
on a strip of clear adhesive
tape. The tape was then adhered
to a clean microscope
slide,
and the number
of glass fibers collected
was enumerated
with
a microscope
configured
for viewing
with white and polarizing
light.
Filter
Surface
Examined
with
a Stereo-Zoom
Microscope.
Packs of Eclipse
and conventional
cigarettes
were opened,
as
described
above,
and the faces of the filters were inspected
for
glass
fibers
with a stereo-zoom
microscope
(Stereomaster;
Fisher
Scientific).
Each filter face, and portions
thereof,
was
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
970
Eclipse
Contaminated
with
:
Glass
Fibers
‘r
A
-AA.
A-A
Fig.
.
./
2.
Glass
fibers
in Eclipse.
a, two packs
of
Eclipse.
as viewed
after inverting
and removing
the bottom
wrapping
paper.
b, close-up
view of
Eclipse,
from the previous
panel.
Illustrated
are
the two mats of glass
fibers
that sandwich
the
tobacco
paper (black
arrow).
Also shown
is the
carbon
fuel rod that is insulated
by the glass
mats. Open arrow,
a bundle
of glass fibers displaced
from the insulation
mats. c, detailed
view
of the tips of two Eclipse
articles
that illustrates
a multitude
of glass fibers that form the insulation mats and carbon
particles
(arrow)
displaced
from the fuel rod. d, glass fibers protruding
from
the tips of two Eclipse
that had been removed
carefully
from a freshly opened
pack. Arrow,
one
of several
glass
fibers
that were
seen on the
surface
of the cigarette.
e, view
with a light
microscope
of the residue
of a pack of Eclipse.
Shown
are numerous
glass
fibers
of variable
length.
Also
illustrated
are glass
fiber-derived
I
particles,
three of which
have been denoted
with
an arrow
(X50).
f view with a SEM of the
broken
end of a glass fiber that was found in the
pack
residue
of Eclipse.
Binder
is present
as
randomly
dispersed
amorphous
dabs as well as a
film-like
substance
(arrow)
dripping
from the
glass fiber surface
(bar,
1.0 sm).
scrutinized
without
removing
the articles
from the pack.
Initially, the field of observation
was adjusted
to permit
imaging
of the whole
filter (15-fold
magnification;
X 1 .5 objective
and
x I 0 ocular).
For a more detailed
viewing
of the filter, we used
the variable
magnification
afforded
by the stereo-zoom
optics.
The magnification
was usually
within an X8 to X40 range. The
resolution
at these magnifications
was about 73 and I 35 lines!
mm, respectively.5
Glass fibers upon and within
the Eclipse
filter were seen
using
a conventional
stereo-zoom
microscope
and standard
illumination.
We learned,
however,
that better viewing
of the
glass
fibers
was achieved
with duel gooseneck
fiber-optic
lamps
from a 4.8-W
halogen
light (Dolan
Jenner
Industries,
Inc., Lawrence,
MA). The lamps
were placed
in an opposing
left- and right-hand
position.
Each lamp was positioned
at an
oblique
angle,
usually
5#{176}
to 15#{176}
to the horizontal.
The advantages
afforded
by this illumination
scheme
were
as follows:
(a) the Eclipse
and conventional
cigarette
filter are
composed
of numerous
cellulose
acetate
fibers, and these fibers
are oriented
longitudinally
to form the cylinder-shaped
filter
plug.
Microscopically,
the on-end
view
of the filter
fibers
revealed
a carpet-like
appearance.
Inspection
of glass fibers on
this morphologically
complex
surface
at high-power
required
5
H. Kaneko
(Carton
Optical
Industries,
Tokyo.
Japan),
personal
communication.
precise
focusing;
(b) both
the glass and cellulose
fibers
are
translucent.
Furthermore,
light was reflected
from the smooth
surface
of both fiber types. When compared
with vertical
lighting, oblique
shadow-casting
illumination
provided
better
dimension
and enhanced
the contrast
of the glass and cellulose
acetate
fibers;
and (c) glass fibers and particles
were seen both
atop and within
the column
of large cellulose
acetate
fibers.
Consequently,
resolving
the glass at different
depths
within the
filter
was facilitated
by adjusting
repetitively
and simultaneously
both the illumination
and focus.
We established
the following
technique
whereby
the filter
of each Eclipse
in a pack could be analyzed
efficiently
and
expediently
for glass fibers with a stereo-zoom
microscope.
In
this method,
one hand was positioned
on one of the gooseneck
halogen
lamps to direct oblique
lighting
onto the cut surface
of
the cigarette
filter,
while
the other
hand was used simultaneously
to adjust
the focus of the microscope.
Filters Assayed for Glass Contaminants
with a Fiber Trans.
fer Test. We have developed
a test for harvesting
loose fibers
and particles
on the surface
of a cigarette
filter for analysis
(16).
The transfer
assay,
as used for detecting
glass fiber contaminants
of the Eclipse
filter,
was conducted
as follows.
We
affixed
to a board
a 3 X 2-inch
piece of clear tape (Scotch
SuperClear;
3M Company,
St. Paul, MN). An Eclipse
or control
cigarette
was orientated
perpendicular
to the tape and positioned
directly
above the tape. Then, the end of the filter was
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
Cancer
touched
the same
the tape.
a clean,
contact
and the
to the adhesive
side of the tape. Immediately
thereafter,
filter was touched
a second time to an adjacent
spot on
The tape was then pressed,
sticky-side
down,
onto to
fiber-free,
3 X 2-inch glass microscope
slide. The two
spots were then examined
with a polarizing
microscope,
glass fibers were counted
and the number
recorded.
Filters
Inspected
for Glass
with
an Electron
Microscope.
The flat face of the test filter was examined
for glass fibers and
particles
with a SEM. In this analysis,
a precleaned
and new
razor blade was used to slice carefully
a 3-4-mm
transverse
section
from the mouth end of the Eclipse
filter. Particular
care
was exercised
not to touch the face of the filter with fingers
or
instruments
so as to avoid
transferring
any extraneous
glass
fibers.
Using
standard
SEM methodologies,
the test filter section was glued in an upright
position
upon an aluminum
SEM
stub. The filter was coated
with gold (Edwards
Model
360
Evaporator;
Grand
Island,
NY). Then
the filter surface
was
viewed
with an Autoscan
SEM (Etec, Inc., Hayward,
CA) or as
described
below.
SEM/EDX
Analysis
of Glass Particles.
Confirmation
of partides
as glass, undoubtedly
arising
from Eclipse
glass fibers,
was established
using
two different
methods:
(a) polarized
microscopy
(Ref. 19; see above);
and (b) analytical
scanning
electron
microscopy
energy
dispersive
X-ray
microanalysis
(20). In the EDX analysis,
we used an Hitachi
5-800
fieldemission
SEM (Hitachi
Scientific
Instruments,
Mountain
View,
CA) with an accelerating
voltage
of 25 kV. X-ray spectra were
collected
with a PGT X-ray
microanalyzer
probe
(Princeton
Gamma-Tech,
Princeton,
NJ). The X-ray spectra
recorded
for
the suspect
glass particles
was compared
with Eclipse-derived
glass fibers.
We have recently
used this methodology
for defining
the elemental
(chemical)
composition
of inhaled
pathdes in human
lungs (21).
Mechanical
Smoking
of Eclipse.
The release
of glass fibers
from the filter of Eclipse
articles
was tested
with a smoking
machine.
The smoking
machine
was constructed
at the Roswell
Park Cancer
Institute
(Electrical
Bioengineering
Instrumentation Center
and Occupational
and Environmental
Safety).
The
machine
was engineered
to permit cigarettes
to be smoked
with
preselected
smoking
conditions.
The machine
smoking
parameters could be varied
to approximate
the smoking
behavior
of
smokers
(6). In these
studies,
the machine
settings
were as
follows:
(a) puff volume,
35 cc; (b) puff duration,
2.0 s; (c) puff
vacuum,
10 mm H20; (d) puff frequency,
one every 60 s; and
(e) total puffs
per Eclipse,
-10.
The glass fiber release
assay was performed
in the following manner.
The filter surface
of an Eclipse
was examined
with
a stereo-zoom
microscope.
X- and Y-coordinates
were established by positioning
four small marks with a black felt tip pen
on the filter tipping
paper. Then, for each filter surface,
a map
was drawn
of the location
and orientation
of glass fibers that
were observed
with a stereo-zoom
microscope.
Thereafter,
the
Eclipse
was positioned
onto the smoking
machine,
ignited
with
a butane
cigarette
lighter,
and smoked
mechanically.
After
smoking,
the filter surface
was reexamined
and compared
with
the original
map. The displacement
of one or more glass fibers
was recorded
as a positive
test.
Results
Displaced
and Protruding
Glass Fibers
Observed
on Eclipse
Article
Tip. The two insulation
mats of glass fibers on the tip
of Eclipse
are shown in Figs. 1 and 2. An on-end
inspection
of
the tip revealed
marked
variation
in the integrity
of the glass
mats; frequently,
clusters
of glass fibers were displaced
(Fig. 2,
Epidemiology,
Biomarkers
& Prevention
In many instances,
glass fibers was seen protruding
from
the insulation
rolls (Fig. 2, a and b). Glass strands
projecting
outwardly
from the mat were detectable
with the naked eye and
were visible readily
with a hand-held
magnifying
glass. Greater
definition
of the glass rods extending
randomly
from the cut
surface
of the Eclipse
tip was obtained
with a stereo-zoom
microscope
(Fig. 2d).
An assay was performed
to define the relative
frequency
of
glass strands
extending
from the Eclipse
tip. In this test, we
a-c).
evaluated
Eclipse
(n = 60) that had been obtained
from three
different
Eclipse
packs (A, Regular;
B, Milds; and C, Menthol).
Each Eclipse
was placed
on the stage of a stereo-zoom
microscope and examined
individually.
The following
scoring
plan
was used to categorize
the number
of glass fibers that extended
1 mm or more from the tip: group I (<5 fibers/Eclipse);
group
II (5-15);
and group
III (> 15). Values
recorded
were as follows: group
I: pack A = 1/20 Eclipse,
B = 3!20, and C
12/20; group II: A = 9/20, B = 1 l!20, and C = 5/20; and group
III: A
9/20, B = 3/20, and C = 1/20. Thus,
63% of the
Eclipse
(n = 38/60)
displayed
five or more glass fibers
that
protruded
1 mm or more from the tip.
Glass
Fibers
Observed
on the Paper
Articles.
Glass
strands
were
wrapper
of the Eclipse
articles,
2i’). No tests were performed
which
glass fibers occurred
on
cause we thought
that it would
the mouthpiece
for glass fiber
Wrappers
of Eclipse
observed
on the white
paper
including
the shaft and tip (Fig.
to define
the frequency
with
the white paper wrapping
bebe more informative
to analyze
contamination.
Glass
Fibers Seen on Cork-like
Tipping
Paper.
An examination was undertaken
to learn whether
glass fibers were present on the cork-like
mouthpiece.
Of the 16 Eclipse
articles
that
we examined,
all tipping
papers
had been contaminated
with
glass strands.
Included
in this analysis
were both Eclipse
(n
12) and NEW
Eclipse
(n
4). Each
Eclipse
was from
a
different
pack and had been collected
randomly.
The number
of
glass fibers on the tipping
paper ranged
from 5 to 44 (mean
±
SE, 23 ± 2.4).
Charcoal
particles,
undoubtedly
derived
from the fuel rod,
were also observed
frequently
on the tipping
paper of Eclipse
and NEW Eclipse.
Also discovered
on the tipping
paper
of
Eclipse,
NEW Eclipse,
and Camel
cigarettes
were cellulose
acetate
particles
and broken
fibers.
In contrast,
no glass
fibers
or charcoal
particles
were
observed
on the tipping
papers of conventional
filter cigarettes
(Camel,
RJR; n = 4). Likewise,
no glass fibers were observed
on the negative
control
slides (n = 4).
Glass
Fibers
Found in Eclipse
Pack Residue.
Having
observed
glass fibers protruding
from the tip of Eclipse
articles
and present
on both the white wrapping
paper and cork-appearing tipping
paper, we undertook
a study to learn whether
glass
fibers were present
in pack residue
of Eclipse.
For all Eclipse
packs examined,
numerous
glass fibers were present
in the pack
residue
(Fig. 2e). The glass fibers
were differentiated
effortlessly
from the few other fiber types that were found
in the
residue
and which included
paper strands
and cellulose
acetate
filter fibers.
Glass fibers
in the pack residue,
however,
were
indistinguishable
from the glass fibers of the mats at the tip of
the Eclipse.
Glass material
in the pack was morphologically
heterogeneous.
Fibers
were
always
observed
and were
of variable
length.
Remarkably
long glass fibers
(>200
m)
as well as
short fibers were observed
in all packs.
Glass that was recognized as components
of the shattered
glass fibers were present
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
971
972
Eclipse
Contaminated
with
Glass
Glass
Fibers
Fibers
REGULAR
2
Seen
liii
On Eclipse
MILDS
Filter
MENTHOL
IllhlIllIllIllllllhl
NEW
20
Fig. 3.
IE
Glass
fibers
seen
on an Eclipse
filter.
The
filters
of Eclipse
(Regular,
Milds,
and
Menthol)
and NEW
Eclipse
were
examined
with a stereo-zoom
microscope
for glass fibers
(n
24 packs).
The number
of Eclipse
and
NEW Eclipse
with glass fibers on the filter for
each
pack
is illustrated
(n = 20 cigarettes/
pack:
ordinate).
Of the 480 Eclipse
articles
examined,
471 (98%)
were contaminated
with
glass fibers. In contrast,
glass fibers were never
observed
on the filters
of conventional
cigarettes,
including
premium
or discount
cigarettes
of RJR and other
cigarette
companies
(not illustrated).
16
12
8
4
0
I
23456123456123456123456
Eclipse
Cigarettes
(Pack Number)
in large numbers.
These
included
glass particles,
fragments,
specks,
and dust (Fig. 2e).
We counted
the glass fibers (3:
1 aspect ratio) present
in
the residue
of each of seven randomly
selected
packs of Eclipse.
The average
number
of glass fibers present
in an Eclipse
pack
was 7,548 (SE ± 3,443; the range was from 1,164 to 26,725
glass fibers!pack;
n
7 packs).
In contrast
to our findings
of
the Eclipse
pack residue,
glass fibers were not observed
in the
residue
of packs (n = 7) of conventional
cigarettes.
A coating,
probably
a glass fiber binding
agent (10), was
observed
on the surface
of some of the glass fibers. Glass fibers
from both the Eclipse
tip and pack residue
contained
the coating. The glass fiber bonding
agent was seen with conventional
white
light and polarizing
microscopes,
and its presence
on
Eclipse
glass fibers could be examined
critically
on the highresolution
afforded
by a SEM (see below).
Glass Fibers Discovered
on Eclipse Filter. The discovery of
binder-coated
glass fibers in the pack residue
suggested
to us
that the glass fibers,
particles,
and dust may have originated
from the insulation
mats at the tip of the Eclipse.
This observation prompted
us to inquire
as to whether
the glass fibers and
particles
from the insulation
mats had moved
onto the face of
the Eclipse
filter. To this end, examinations
were performed
to
ascertain
whether
glass fibers,
particles,
and fragments
were
present
at the mouth
end of the Eclipse
cellulose
acetate
filter.
Our inquiry
revealed
that glass fibers were observed
easily and
routinely
on the Eclipse
filter. Moreover,
as will be described
in
greater
detail below,
the glass fibers observed
on the filter were
indistinguishable
by SEM and SEMIEDX
from glass fibers in
the pack residue.
Our findings
were documented
further
in a comparative
assay of Eclipse
(Regular,
Milds,
and Menthol;
six 20-count
packs of each of the three styles).
Conventional
premium
and
discount
cigarettes
(n = 10 packs)
were used as controls.
Most
all (98%)
of the Eclipse
filters (n = 352/360)
were comipted
with glass
fibers
(Fig. 3). Values
recorded
for each of the
different
Eclipse
styles were: Regular,
95.0%
(n = 1 l4!l20);
Milds,
98.3%
(n
1 18!l20);
and Menthol,
100% (n = 120!
120).
Glass fibers were discovered
also on the filters of Eclipse
that had been obtained
from other countries
(Hi-Q and Inside).
Similarly,
the filters
of Premier
were also contaminated
with
glass fibers.
More recently,
RJR introduced
Eclipse
with a new filter
design.
We included
these NEW
Eclipse
into our studies
to
determine
whether
the defect of glass fiber contamination
of the
filter
had been corrected.
Almost
all of the NEW Eclipse
articles
examined
had filters with glass fiber contaminants.
In
our assay of 120 NEW Eclipse,
all but 1 (n = 1 l9!120;
99.2%)
were contaminated
with glass fibers (Fig. 3).
Conventional
cigarettes
were also analyzed
for glass contaminants.
Cigarettes
assayed
included:
Winston
and Doral
(RJR); Marlboro
and Basic (Philip Morris,
Inc.); Kool and GPC
(Brown
and Williamson);
L&M and Lark (Liggett
Group);
and
Newport
and Kent (Lorrilard).
Of the 10 packs examined,
glass
fibers were never observed
on the filters of these cigarettes
(n =
0!200 cigarettes).
Thus, glass fiber contamination
of the filter is
unique
to Eclipse
and could
not be attributed
to a common
manufacturing
flaw that would
corrupt
the filters
of conventional cigarettes.
The contamination
of Eclipse,
HiQ,
Inside,
and NEW
Eclipse
with glass
fibers
was commonplace,
extensive,
and
global.
Furthermore,
test results of Premier
illustrate
that glass
fiber contamination
of the filter had persisted
for years.
Glass Fibers
on Eclipse
Transfer
Test. Glass fiber
Filters
Identified
with
a Fiber
contamination
of the Eclipse
filter
was corroborated
further
in the fiber transfer
test (see “Materials and Methods”).
In this test, we analyzed
the filters of eight
Eclipse
from each of three randomly
selected
packs. Of the 24
Eclipse
filters
analyzed,
all were contaminated
with glass fibers; two-thirds
(n = 16!24) had 20 or more fibers
(Fig. 4). The
number
of glass
fibers
harvested
ranged
from
5 to 55 per
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
Cancer
Glass
Fibers
On Eclipse
(Fiber Transfer
Fig. 4.
Glass
fibers
on an Eclipse
filter defined
in the fiber transfer
test.
Results
of an experiment
in which
the transfer
test (see “Materials
and
Methods”)
was used to define
glass
fibers
on filters.
In this analysis.
eight randomly
selected
Eclipse
cigarettes
were removed
from three different Eclipse
packs.
The number
of
glass fibers present
on each of the 24
Eclipse
filters
is illustrated
(glass
fibers
per
filter;
range.
5 to 55:
mean ± SE, 26.2 ± 2.6). In contrast.
using
the
same
assay
procedure,
glass fibers
were never observed
on
the filters
of 24 conventional
cigarettes (not illustrated).
Epidemiology,
Biomarkers
& Prevention
Filter
Test)
70
18888881
G)
‘j-
o)
(I)
0.
Pack
1
Pack
2
Pack
3
60
50
7A
C.)
w
a)
0
40
Cl)
30
a)
-o
20
I-
IiU)
Ct’)
10
0
0
123456781234567812345678
Eclipse
filter (mean
± SE = 26.2 ± 2.6; Fig. 4). In the same
assay, glass fibers were never (n = 0!24) observed
on the filters
of conventional
cigarettes
(not illustrated).
Glass
Fibers on Eclipse
Filter Revealed
by SEM. Highresolution
viewing
of the glass contaminants
of Eclipse
and
NEW Eclipse
filters
was achieved
with a scanning
electron
microscope
(Figs. 5 and 6). Detailed
viewing
of glass fibers and
glass particles
on Eclipse
and NEW Eclipse
filters was obtained
easily
and frequently.
Two morphological
features
that were
particularly
useful
in distinguishing
microscopically
the glass
fibers
and cellulose
acetate
fibers
of the Eclipse
filter
are
illustrated
in Fig. 5, a and b: (a) the glass fiber had a rod-shape,
whereas
the cellulose
acetate
fiber had a distinct
Y-shape;
and
(b) the size of the cellulose
acetate
fiber was invariably
larger
than that of the glass fiber.
The position
and orientation
of the glass fibers on the filter
surface
varied markedly.
Most of the glass fibers were observed
lying upon the filter surface
(Fig. 5, a and d). Some glass rods,
most of which
were relatively
short, were observed
positioned
behind
a cellulose
acetate
fiber (Fig. 5, a and b). Some glass
fibers
were hidden
deep within
the cellulose
acetate
bundle
(Fig. 5a). Notable
was the frequent
appearance
of glass fibers
of different
lengths
that were observed
standing
upright
(Fig.
Sc) and lying down
(Fig. Sd) on a wing of a Y-shaped
cellulose
acetate
fiber on the surface
of the filter.
In each of the cases cited above
as well as for all other
critical
examinations,
we failed to detect any evidence
that the
glass
fibers
on the filter
surface
were
affixed,
connected,
bonded,
or glued.
Specifically,
we were
unable
to identify
binding
by the glass fiber bonding
agent or the cellulose
acetate
plasticizer
(e.g.,
triacetin).
Thus, in many instances,
glass fibers
rested
freely upon the filter surface
and in a position
whereby
it would
be reasonable
to predict
that they would
be released
unabated
and readily
during
smoking.
Evidence
in support
of our prediction
that the glass fibers
could be released
readily
was obtained
in a serendipitous
observation
made
in studies
in which
the Eclipse
and NEW
Eclipse
filters
were examined
with a SEM.
For all light and
electron
microscopy
observations,
it is a common
practice
to
observe
the tissue
or item at low power
and then,
without
changing
the field of view, advance
to a higher power.
Accordingly, we would screen an Eclipse
filter at low power
for glass
fibers.
Having
identified
a glass fiber of interest,
the microscope was adjusted
to provide
viewing
with a higher
magnification.
Operationally,
a portion
of the Eclipse
filter was obtamed randomly
and viewed
at a relatively
low magnification
of
-x 12,500. Having identified
a glass fiber, a photograph
was
collected
for documentation.
Thereafter,
the same fibers were
viewed
at a high power.
However,
“charging”
occurred
often,
and this release
of electrons
caused
the glass fiber to jump from
the field of view. In some instances,
the glass fiber was observed
on another
position
on the filter; in other cases, it could
not be found.
The displacement
and release
of the glass fiber
was due to an excess charge
injected
by the electron
beam that
could
not flow to ground.
The build
up of charge
in the
cellulose
acetate
fibers
and the glass fibers
repelled
the two
fiber types, resulting
in the ejection
of the glass fibers from the
electron-enriched
area. Recall,
however,
in all electron
microscopy applications,
the specimen
(e.g.,
Eclipse
filter) is viewed
in a sealed
air-tight
vacuum
column
positioned
on a lowvibration
air-table.
Thus, the displacement
of the glass fiber was
caused
by an electrical,
and not mechanical,
action.
Length
and Diameter
of Glass Fibers Defined by SEM. The
morphology
and dimensions
of the glass fibers and glass partides
were analyzed
by SEM (Fig. 6). Long (>200
p.m) and
short glass
fibers
were observed
lying
upon the surface
of
cellulose
acetate
filter
fibers
(Fig. 5, c and d). Glass
fiber
diameters
were relatively
uniform
(-5
pm; range,
4-6
jim).
For some
glass
fibers,
the ends displayed
sharp
transverse
breaks,
whereas
other
glass
fibers
displayed
uneven,
fragmented
ends (Figs. 2fand 5, a-c).
The surface
of the glass fiber
was relatively
smooth.
Fiber binder
on the glass fibers
was
prominent
(Fig. 2f and 5a) and amorphous
(Fig. 5, a and b).
Glass
Fragments
Identified
by SEMIEDX.
Glass rod
ments and debris were observed
by light microscopy
in the
residue
of Eclipse
(Fig. 2e). SEM examination
of the
residue
showed
that the observed
particles,
thought
to be
fragpack
pack
from
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
973
974
Eclipse
Contaminated
with
Glass
Fibers
Fig. 5.
Glass
fibers
on Eclipse
filter imaged
with a SEM.
Glass
fibers
on the Eclipse
filter
were seen frequently.
readily,
and in great detail with a SEM. All panels
present
views looking down
onto the cut surface
of an Eclipse
filter face. These
panels
illustrate
that the glass
fibers
were not bound
to the plastic-like
cellulose acetate
filter fibers.
Furthermore,
the perspectives
illustrate
the ease
with which
the
glass fibers would be released
into the smoker’s
mouth.
a, the surface
of an Eclipse
filter exhibiting three glass fibers
(arrows).
The glass fibers
were
distinguished
promptly
from
the
large Y-shaped
cellulose
acetate
filter fiber (*).
Binder
or binder-like
material
(sharp
arrow)
is
shown
streaming
from the surface
of one of the
glass
fibers.
Bar, 10.0 sm.
b, glass
fiber
(length,
-135-140
sm), balanced
on a curved,
Y-shaped
cellulose
acetate
filter
fiber.
This
view
illustrates
further
the ease
with
which
glass
fibers
and cellulose
acetate
fibers
were
distinguished
morphologically.
Bar, 10 sm. c,
single short glass fiber (arrow),
standing
freely
on its broken
end, on the surface
of a cellulose
acetate
filter fiber. Bar, 1.0 jzm. d, broken
short
glass fiber lying upon the surface
of one of the
three arms of a Y-shaped
cellulose
acetate
filter
fiber. Bar, 1.0 m.
glass fiber breakage,
were morphologically
heterogeneous
and
included
glass chips, specks,
and dust. To substantiate
unequivocally that these items were glass and not of other material,
the
chemical
element
composition
of the particles
was defined
by
SEM/EDX.
Fig. 6d shows
a view of a single
glass fiber and three
adjacent
particles
that are morphologically
dissimilar.
The histograms
ofthe elemental
analysis
ofthe glass fiber (Fig. 7) were
compared
with those of the suspect
particles.
The histogram
of
the fiber revealed
a major peak of silicon
and smaller
peak of
calcium
(Fig. 7). The SEM/EDX
profile
of the glass chip (Fig.
7, inset) was indistinguishable
from that of the fiber. These and
other
SEM/EDX
profiles
of fragments,
particles,
chips,
and
items
1 .0 p.m were
authenticated
as being
of glass.
We
concluded,
therefore,
that these glass particles
and fragments
originated
from
fracture
and breakage
of the Eclipse
glass
fibers.
Glass Fibers
Released
from Eclipse
Filter During
Smoking.
From
our extensive
examinations
of Eclipse
filters
with a
stereo-zoom
microscope
and SEM, we concluded
that the number, size, position,
orientation
of the unbound
glass
fibers,
fragments,
and particles
on the cellulose
acetate
filter surface
would
suggest
that some of the glass items would
be released
into the smoker’s
mouth
during
smoking.
Notwithstanding,
tests were performed
in which
Eclipse
articles
were smoked
mechanically
to determine
whether
glass fibers were released
during
smoking.
Positive
results
were recorded
for 80% of the
Eclipse
articles
studied
(ti
=
l2!15).
Noteworthy
was that the comparison
of the maps drawn
for the glass
fibers
on the Eclipse
filters
before
and after
smoking
often
revealed
the
appearance
of previously
unidentified
glass fibers.
The newly
discovered
glass fibers
were
thought
to have been
drawn
up from
an undetected
position,
most likely deep within
the colonnade
of cellulose
acetate
fibers,
to the
filter
surface
during
mechanical
smoking.
Discussion
In studies
reported
herein,
we have: (a) observed
glass fibers
and other glass contaminants
lying freely on the cut surface
of
filter by light and electron
microscopy;
(b) failed
to detect any
evidence
to suggest
that these glass fibers were bound or glued
to the filter surface
with binding
agents,
plasticizers,
or other
materials;
(c) discovered
that the glass items
were liberated
from the filter by touching
to tape. Inevitably
the glass items
would
move easily
from the cut surface
of the filter to the
smokers
lips and tongue;
(d) shown
that the glass fibers lying
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
Cancer
Epidemiology,
Biomarkers
& Prevention
Fig. 6.
Glass
fiber
contamination
of NEW
Eclipse
filter
and SEM
confirmation
of glass
particles.
This figure
illustrates
glass fiber contamination
of the customized
filter of a NEW
Eclipse
and documents
the presence
of glass
particles
as originating
from Eclipse
glass fibers.
a, a view with a stereo-zoom
microscope
of two
glass fibers (arrows)
that are observed
ea.sily as
protruding
toward
the opaque,
black-appearing.
hollow
central
cavity
of the cellulose
acetate
filter
of a NEW
Eclipse.
The displaced
glass
fibers of the NEW Eclipse
can be distinguished
quickly.
even in this low-power
view, from the
single.
thick. curved
cellulose
acetate
filter fiber
that has been dislocated
and is prominent
between
the two arrows:
b, SEM view illustrating
the heterogeneity
in the size of the Eclipsederived
glass contaminants
that range from dongated fibers to dust-like
specks
(bar, 60 pm); c,
high-power
view of a single
glass particle.
Arrow, a sharp
fracture
plane
where
this particle
broke
from a glass fiber.
Binder
or binder-like
material
is shown
on all surfaces
of the particle
(bar, I .0 sm);
d. SEM
view of a glass
fiber
(right side) and adjacent
morphologically
heterogeneous
particles
particles:
were glass
(see
7: bar,
Fig.
confirmation
was achieved
a
that the three
by SEMIEDX
2 .tm).
on the cut surface
of the filter were moved
by charging
that
occurred
during
SEM observations;
and (e) glass fibers on the
filter were displaced
during
mechanical
smoking
of Eclipse.
Comiption
of the filter with glass fibers was documented
in tests of Premier,
Eclipse,
NEW
Eclipse,
HiQ, and Inside.
Thus,
glass pollution
of the filter of Eclipse
was widespread,
collective,
and continuous.
Experiments
similar
to those performed
using
Eclipse
were also carried
out on conventional
cigarettes,
and in no instance
was even one glass fiber discovered.
The glass fibers observed
on the filter, in the pack residue,
and on the white wrapper
paper and tipping
paper ofthe
Eclipse
articles
were optically
and morphologically
indistinguishable
from the glass fibers of the insulation
mats at the tip. Moreover,
the glass particles
were chemically
indistinguishable
from the
glass fibers as defined
by SEMIEDX.
The observed
glass
fibers
and particles
on the Eclipse
filter were undoubtedly
from the glass fiber insulation
mats.
We envision
that the brittle
and thin glass fibers of the mats
were fractured
and shattered
during
high-speed
Eclipse
manufacturing,
particularly
during
the process
in which
the glass
mats and carbon
fuel rod are bisected
transversely.
In support of this perception
is the observation
that fragments
of
plastic
fibers,
such as cellulose
acetate
fibers,
forming
the
mouthpieces
of filter
cigarettes
tend to become
separated
from the filter mouthpieces
during
cutting
and contaminate
the area around
the filter (Ref. 22; see also Refs.
16 and 38).
Thus,
the glass
particles
would
be produced
by cutting
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
975
976
EclIpse
Contaminated
with
Glass
Fibers
4.0k
3’
3.6k
Glass
fiber
::
Glass chip
3.2k
2.4k
4;
-
a
s
$
7
#{149} #{149}
I#{149}
1.2k
80#{128}
404
HH
0
0.00
1.00
2.00
3.00
4.00
5.00
Energy
7.00
8.00
9.00
10.00
(keY)
Fig. 7.
Glass fibers
and glass particles
defined
by SEMIEDX.
SEM/EDX
profiles
defining
glass particle
(Fig. 6). The large histogram
is the SEMIEDX
profile
of the glass fiber illustrated
profile
(small
histogram.
inset) recorded
for the glass chip shown
in Fig. 6d.
Eclipse.
In addition,
glass
fibers
would
be shattered
during
subsequent
operations,
including
rapid packaging
and shipping. The glass debris
attaches
nonspecifically
to all surfaces
of the Eclipse
articles.
Most
importantly,
the glass
fibers,
particles,
and fragments
translocate
to the cut surface
of the
mouthpiece,
where
they
were
found
atop
and entangled
loosely
within
the carpet-like
filter
surface.
Eclipse
is packaged
standing
on its tip. Thus,
the glass
fibers protruding
from this end would be susceptible
to breakage resulting
from jostling
that would occur during daily transport by the smoker,
particularly
if the Eclipse
package
was only
partially
filled.
Furthermore,
the likelihood
of glass debris
in
the pack residue
contacting
and adhering
to the cut filter face
would
be greatly
increased.
Studies
reported
herein
were conducted
using
Eclipse
from freshly
opened
packs.
We would
anticipate,
therefore,
finding
a larger number
of glass fibers,
particles,
and fragments
on the filters
of Eclipse
articles
of
in-use
packs.
Eclipse
has been viewed
favorably
by some who perceive
it as a smokeless
cigarette
that yields relatively
low amounts
of
tar, nicotine,
and ash (4, 5, 7, 13). It has been argued
that
Eclipse
provides
an alternative
smoking
article for health-conscious smokers
who are: (a) unwilling
to abstain
from smoking;
(b)
nicotine-addicted
and are unable
to quit; and/or
(c) concerned
with the health risks of passive
smoke
and who wish to
reduce the exposure
of smoke to children,
family members,
and
others
(1-3, 4, 6, 7, 9-14).
In contrast,
some reviewers
have asserted
that Eclipse
is
6.00
the elemental
(chemical)
composition
in Fig. 68. This SEM/EDX
profile
of an Eclipse-derived
was indistinguishable
glass fiber and
from SEMIEDX
not a cigarette,
and that Eclipse
should
be classified
as a
nicotine
delivery
device (5, 1 1). Others
have perceived
Eclipse
as a ploy to challenge
clear-air
regulations
banning
cigarette
smoking
in designated
areas (4, 7). Some analysts
who have
studied
Eclipse
believe
that a nicotine-addicted
smoker
will
accept
these drawbacks
and use a less favorable,
smokeless,
nicotine-dispensing
smoking
article
in a restricted
clear-air
environment
until a full-flavor
conventional
cigarette
can be
smoked
in an unrestricted
area (4, 7, 1 1).
Accordingly,
the goals
for Eclipse
declared
by RJR, the
perception
by others of RJR motives,
and the anticipated
use of
Eclipse
have varied markedly.
Likewise,
the health
benefits
to
be realized
by the Eclipse
and NEW Eclipse
user have been the
subject
of debate (4, 7, 9, 1 1, 14). Regardless
of the intent, RJR
has spent a considerable
amount
of time and money
on Eclipse
during
a time when their share of a highly
competitive
market
has declined
(14).
A leaflet
that accompanies
each pack of Eclipse
instructs
the smoker
to “take an extra puff and a longer
draw while
holding
a flame
to the carbon
tip.” The increased
vigor
of
puffing
would increase
further
the probability
that glass fibers,
particles,
and fragments
would be discharged
into the smoker’s
mouth
during
smoking.
In an apparent
attempt
to correct
the
hard draw, the mouthpiece
of the NEW Eclipse
was redesigned.
It consists
of a filter-appearing
rod (diameter,
-7 mm) having
a central
longitudinal
passageway.
This tunnel
(diameter,
-4
mm) spans the truncated
filter rod (length,
-9 mm). Thus, the
short hollow
mouthpiece
of the NEW Eclipse,
shown in Fig. 6a,
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
Cancer
is thought
to achieve
little or no filtration
of the smoke,
including both the tar and vapor-phase
components.
When
viewed
on-end,
glass strands
were seen readily
protruding
from the
white cellulose
acetate
bundle
into the central,
black-appearing
tunnel
(Fig. 6a).
RJR has not revealed
to the Eclipse
smoker
the use of glass
fibers.
Known
Eclipse
smokers
included
thousands
of individuals who were paid participants
of test panels that were assembled in different
cities. Today,
Eclipse
articles
are available
on
the open market
and are being smoked
by people
in different
countries
(United
States, Germany,
Sweden,
and Japan;
Refs. 1
adn 14). RJR did not disclose
to the consumer
the presence
of
glass fibers in Eclipse
in: (a) a package
warning
label; (b) an
instructional
brochure
that was included
in each pack;
(c)
promotional
video tapes; or (6) newspaper
advertisements.
The health risks and hazards
associated
with glass fibers in
RJR’s
Premier
and/or
Eclipse
smoking
articles
have been addressed
specifically
in two documents.
The first document
is a
U.S. patent,
filed in 1992 and awarded
in 1994, to inventors
Serrano
et al. (23) and assigned
to Philip Morris,
Inc. The Philip
Morris
patent
describes
the construction
of a smoking
article
delivering
a nicotine-containing
flavored
aerosol
rather
than
conventional
tobacco
smoke.6
This invention
relates
to a: “...
smoking
article
in which
the sensations
associated
with the
smoking
of tobacco
are achieved
without
the burning
of the
tobacco.”
The aerosol
is generated
by a convective
and radiative heat transfer
from a burning
pure carbon
rod. A claim is
made
that the article
generates
substantially
no sidestream
smoke.
The intent, as well as some design
features,
are similar
to RJR’s
prototypes
(7), Premier
and Eclipse
(2, 3, 5, 6).
In presenting
the background
of their
invention
(23),
Philip Moms
makes reference
to a U.S. patent assigned
seven
years
previously
to RJR for an Eclipse-like
smoking
article
(26). Philip
Morris
argues
that the RJR device:
“.
. .
suffers
from a number
of drawbacks.
First, the resilient
glass fiber
insulating
jacket
is difficult
to handle
on modern
mass production machinery
without
special
equipment.
Second,
the glass
fibers
may become
dislodged
during
shipping
and migrate
through
the pack to rest on the mouth end of the article,
giving
rise to the potential
for the inhalation
of glass fibers
into the
smoker’s
mouth”
(23). In an additional
warning,
Philip Morris
claims:
“It is a further
objective
of this invention
to avoid the
potential
for inhalation
of glass fibers by a smoker
of such an
article”
(23).
The second
document
was a lawsuit
filed against
RJR for
using glass fibers
in their new cigarettes
(27). The litigation
against
RJR was filed in March
1995 by Schuller
International,
Inc.8 In this action,
Schuller
sought
to bar its glass fibers from
being used in: “the manufacture
of a new cigarette
product
for
sale to the public”
(27). In the summer
of 1993, RJR asked
Schuller
to supply
between
20,000
and 50,000
pounds
of “C”
glass fiber to RJR by December
1993 (27). “C” glass fiber had
a higher
heat tolerance
than ‘T’ glass fibers.
The ‘T’ glass
Philip
Morris,
Inc. has announced
the development
of a battery-powered,
low-smoke,
ultra-low
tar, cigarette-appearing
smoking
system
called Accord
(24,
25). This smoking
device,
produced
to address
health concems
for environmental
smoke
and potential
fire hazards,
is presently
being
evaluated
in test panels
of
smokers
for consumer
acceptability
(24).
7 Eclipse
was announced
to the public
on Nov. 27, 1994 by the The New York
6
Times (4). Eclipse
was evaluated
for two years in 20 different
states and by test
panels having
collectively
more than I 2,000 smokers
but without
the knowledge
of the Food and Drug Administration
(4).
8 Schuller
was known
formerly,
and is known
currently.
as Johns Manville.
Johns
Manville
was the target in the 1980s of numerous
claims related
to health hazards
associated
with inhalation
of asbestos
fibers (27, 28).
EpIdemiology,
Blomarkers
& Prevention
fibers that had been supplied
previously
had been shown to fuse
in the smoking
article during testing (27). Schuller
claimed
that:
“.
. . all
purchases
of ‘C’ glass fiber by RJR were understood
by
both parties
to be used only for developmental
purposes
and not
commercial
production
of a new cigarette
product”
(27).
Arguments
were also presented
in the lawsuit
to provide
indemnification
of Schuller
by RJR (27-29).
These arguments
related to a draft of a “Specialty
Supplier
Agreement”
for the
sale of glass fibers (27). The draft contained
a provision
providing
that Schuller
would:
“.
. . defend,
indemnify
and hold
harmless
[RJR]. . . against
all claims,
damages,
losses and expenses
. . . attributable
to . . . (a) bodily
injury,
or death
. . .
(27).
The lawsuit
further
declares
that: “Schuller
and RJR have
never resolved
either Schuller’s
policy concerns
or the scope of
indemnification
or other contractual
protections
that RJR would
provide
Schuller
in the event
that the two companies
could
establish
a continuing
business
relationship”
(27).
Schuller
withdrew
the case on May 5, 1995 after reaching
a settlement
with RJR (30, 31). The terms of the accord
were not disclosed
other
than Schuller
would
no longer
supply
RJR with glass
fibers (31).
The association
of fibrous
glass
and cancer
has been
addressed
in a document
authored
by investigators
from the
Environmental
Carcinogenesis
Program
of the National
Institutes of Environmental
Health
Sciences,
Duke University
Medical Center,
and the Occupational
Safety
and Health
Administration
of the United
States
Department
of Labor
(17). These
examiners
declared
“that fibrous
glass materials
are carcinogenie . . . “ (17). This assessment
included
an analysis
of data
from both laboratory
experiments
(e.g.,
animal
studies)
and
epidemiological
studies
(human
data; Ref. 17). Furthermore,
they concluded:
“.
. . that
on a fiber-per-fiber
basis, glass fibers
may be as potent
or even more
potent
than asbestos”
(17).
Letters
presenting
opposing
view points
have been presented
(32-34).
These letters were followed
by a concluding
response
and rebuttal
(35). RJR has discussed
their perception
of the
potential
toxicity
associated
with the use of the glass
mat
insulator
in the Premierand Eclipse-like
“NEW
CIGARETTE”
prototypes
(10). No results
or discussions,
however,
were presented
for RJR’s proposed
analysis
of “glass fibers”
in
“mainstream
smoke”
(Table
3.4.3-1
in Ref. 10) or subsequent
RJR publications.
Health
risks of fibrous
glass (i.e.
glasswool;
respirable
size) have been reviewed
also by the NTP of the United
States
Department
of Health
and Human
Services.
For many
years
they have and continue
to assign
glasswool
in a category
for a
“substance
or group
of substances
and medical
treatments
which may reasonably
be anticipated
to be a carcinogen”
(Ref.
36; see also Ref.
17). Other
agents
listed
in this grouping
include:
(a) ceramic
fibers (respirable
size); (b) PAHs [n
15;
e.g., benzo(a)pyrene];
(c) dioxane;
(d) polychlorinated
biophenyls;
and
(e) 1,l-bis(p-cholorophenyl)-2,2,2-trichloroethane
(DDT; Ref. 36). The NTP notes further
that “there is sufficient
evidence
for the carcinogenicity
of glasswool
in experimental
animals”
(17).
Inhaled
glass fibers
(37) and glass dust (38) have been
isolated
from the lungs of affected
patients
with lung disease,
and the glass material
was identified
unequivocally
by SEMI
,
EDX
(37).
In January
1998, the NTP upgraded
crystalline
silica (respirable
size; e.g., quartz;
Ref. 39) to that of a “known
human
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977
978
Eclipse
Contaminated
with
Glass
Fibers
carcinogen.”9
Glass fibers and microparticulates,
as is known
for crystalline
silica, may induce
inflammation,
fibrosis,
hyperplasia, or other nonmalignant
pulmonary
diseases
(17, 36-39).
We (16, 40, 41) and others (42, 43) have documented
the
discharge
of different
types of foreign
bodies
from cigarette
filters,
including
cellulose
acetate
filter fibers
(16, 40, 41),
asbestos
fibers (43), and carbon
from cigarettes
with charcoal
filters (40, 42), cigarette
paper fibers (42), crystalline
materials
(“cellulose
acetate
additives”;
Ref. 42), and unidentified
partides
(42).
In studies
in which
conventional
cigarettes
were
smoked
mechanically,
crystalline
material
and filter material
additives
were released
(42); the size of these particles
were
within
the submicron
range (1/20 to 1/40 tim; Ref. 42). The
release
of various
fibers and particles
from cigarette
filters was
documented
with a transmission
electron
microscope
in studies
funded
by the Brown
and Williamson
Tobacco
Company
(42).
These
comprehensive
scientific
findings
were presented
in a
109-page
monograph
that was published
-40
years ago (42).
Philip Morris,
Inc. has known and tested routinely,
beginning
as
early as the l970s, cigarette
filters for the “fallout”
of cellulose
acetate
fibers (44) and charcoal
(45).
Today’s
smoker
is unaware
that cigarette
filter elements
of
different
origin
and size are being released
into their mouths
during smoking.
These consumers
are uninformed
that tar- and
toxin-coated
biopersistent
filter components
will be inhaled
and/or
ingested
during
normal
smoking
behavior.
Battery
by
these filter elements
is not part of the smoking
experience.
Today,
both conventional
and nonconventional
smoking
articles
are being marketed
as having
a greater
consumer
benefit, including
reduced
health risks and decreased
environmental smoke.
Paradoxically,
the filter was designed
to absorb
and
trap tar in cigarette
smoke.
Tobacco
tar binds
rapidly
and
tenaciously
to most all surfaces
(e.g.
glass, plastic,
cotton,
and
paper).
The binding
of tobacco
tar to glass
fibers
used in
prototype
cigarette
filters
has been known
for many
years.
Likewise,
the use of glass fiber filters (e.g.,
Cambridge
filters,
Ref. 15) in smoking
machines,
for the quantitative
assessment
of tar, as well as glass flasks,
used for the condensation
of
tobacco
smoke
for extracting
different
tar components,
is
known
widely
(see also Ref. 46). Furthermore,
it is widely
accepted
that the adsorption
of tobacco
tar onto glass fibers is
nonspecific,
efficient,
and rapid (47-49).
In this context,
we
have observed
that tobacco
tar binds to the Eclipse
glass fibers.
The enhanced
health
hazard
associated
with
cigarette
smoking
and fiber/dust
inhalation
has been discussed
by many
scientists.
The synergistic
effects
of tobacco
smoking
and inhaled asbestos
have been well documented.
We hold the opinion that an increased
health
risk may arise from the inhalation
of tar-coated
glass and/or cellulose
acetate
fibers and particles.
Support
for this expectation
is derived
from studies
similar
to
that reported
herein.
For example,
the adsorption
of PAHs,
from tobacco
smoke,
onto asbestos
fibers has been postulated
for the known
syncarcinogenic
effect
of cigarette
smoke
and
asbestos
(48, 49). This “PAH carrier
hypothesis”
proposes
that
asbestos
fibers
carry PAH into the cells and influence
their
metabolism.
An alternative
hypothesis
predicts
that the fiber
acts as a complete
carcinogen
when it is chronically
retained
in
the bronchial
wall (49). In this “fiber implantation
hypothesis,”
the irritants
and toxins
contained
in tobacco
smoke
serve as
efficient
cocarcinogens
by damaging
the bronchial
mucosa
and
impairing
the bronchial
clearance
mechanisms
(49). A similar
,
NTP. 9th
Classification
9
Report
on Carcinogens
(Attachment
3). January
Group
I: “carcinogenic
to humans.”
1998.
Also
see IARC
opinion
was expressed
by Fan and Revere
(42) in 1958 in
describing
their observation
of the discharge
of particles
from
cigarette
filters:
“In view of the accumulated
medical
evidence
concerning
the greater
irritation
to the respiratory
tract from a
solid particle
with a coating
of hydrocarbon
than from either the
particle
or hydrocarbon
alone, the need to eliminate
solid particulate
material
from the smoke
streams
would
seem to be
indicated.”
Eclipse-derived
glass released
into the smoker’s
mouth
may also become
entrapped
in the saliva
and, subsequently,
swallowed.
Thus, some of the glass fibers and glass microparticulates
are likely
to be ingested.
Accordingly,
the mouth,
respiratory
tract, and digestive
system
are at risk to toxin-coated
bioresistant
glass discharged
from Eclipse.
In this context,
glass
in foods is recognized
by the Food and Drug Administrations
as
extraneous
matter
for which there is zero tolerance.
Our studies
have documented
glass fiber contamination
of
the filter and substantiates
with reasonable
certainty
that glass
fibers would be inhaled
andlor ingested
when Eclipse
is smoked
as intended.
These
findings
and known
risks associated
with
glass
fibers
delineate
and designate
Eclipse
as a defective
product.
The filter of conventional
cigarettes
is perceived
as both
efficient
and safe. However,
the American
Thoracic
Society,
the Medical
Section
of the American
Lung
Association,
adopted
in 1995 this official
statement:
“Epidemiological
studies have shown that brands of cigarettes
that contain
less tar and
nicotine
only marginally
reduce
the risk of lung cancer
mortality. Similarly,
little difference
in mortality
has been found for
lifelong
filter versus
nonfilter
smokers
and for persistent
smokers who switch
from nonfilter
to filter cigarettes”
(50).
Many
U.S. patents
are being awarded
yearly
to tobacco
companies
for technically
complex
multiple
component
cigarettes consisting
of tobacco-like
material
with assorted
chemical additives
(1, 4). Some will be promoted
as safer cigarettes
with lower health risks (23). Other low-smoke,
nicotine-delivery devices,
also having
the appearance
of cigarettes,
will be
introduced
to avoid clean-air
ordinances
(4).
Cancer
prevention,
particularly
smoking
cessation,
will
continue
to be a primary
goal of health
organizations
throughout the world.
There exists,
however,
no regulatory
body that
provides
an independent
analysis
of cigarettes.
Unlike the products of the food, drug, and cosmetic
industries,
smoking
articles
and chewing
tobacco
of the tobacco
industry
remain
unregulated. Thus, the question
posed to the medical,
scientific,
and
public health communities
remains
unanswered
as to who will
define the health risks imposed
on the nicotine-addicted,
uninformed
smokers
who participate
in worldwide
market
tests of
experimental
tobacco
articles.
We believe
that smokers
have the right to be educated
fully of any and all health
hazards
and risks associated
with
particular
brands
of cigarettes
that are offered
for sale. RJR has
promoted
Eclipse
as a “great-tasting
cigarette
with less secondhand smoke,
no ashes,
no lingering
odor, and practically
no
staining
on walls, windows,
and curtains”
(RJR’s
promotional
video).
It is what RJR has failed to tell consumers
about Eclipse
that concerns
us. Contamination
of Eclipse
filters
with glass
fibers and glass dust may pose an additional
health risk to the
smoker.
Eclipse
is a paradigm
of the health danger
that may be
imposed
by technically
complex
tobacco
articles
and nicotine
delivery
devices
promoted
by an unregulated
industry
preying
upon addicted
smokers
who seek a less hazardous
cigarette.
Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
Cancer
Acknowledgments
We
acknowledge
the
assistance
of
Bamhart,
Stephen
Cathleen
Hrusa,
Charles
Stuffier
of Medical
Photography,
Elena
trations,
and Gayle
Ablove
of the Medical
and Scientific
Dr. Richard
Cheney
for critical
review
of the manuscript.
Note
Added
Pauly
and
Nasca,
Houck,
W. G. Philip
13, 1994.
Lynn
Greco
of Medical
Library.
We also
24. Collins,
G. Analysts
system,
p. 1. New York
Illusthank
have
reported
earlier
this
year
the discovery
of cellulosic
and plastic
fibers
in surgically
excised
human
lung tissue
and malignant
tumors
(Pauly,
J. L., Stegmeier,
S. J.. Allaart,
H. A., Cheney,
R. T., Zhang,
P. J.. Mayer,
A. G., and Streck, R. i. Inhaled cellulosic
and plastic fibers found in human lung
tissue.
Cancer
Epidemiol.
Biomark.
Prey. 7: 419-428,
1998).
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Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research.
Glass fiber contamination of cigarette filters: an additional
health risk to the smoker?
J L Pauly, H J Lee, E L Hurley, et al.
Cancer Epidemiol Biomarkers Prev 1998;7:967-979.
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