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 Downloaded from cebp.aacrjournals.org on October 2, 2016. © 1998 American Association for Cancer Research. 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). References 1 . Anonymous. p. 62, April, RJR 1997. tests new technology intemationally. 2. Glantz, Cigarette S. A., Slade, J., Bero, L. Papers, pp. 1-539. Berkeley, A., Hanauer, CA: University 3. Glass, C. Testing Reporter, Eclipse. 4. Hilts, P. J. Little pp. 1 and 38, Nov. Tobacco smoke, little 27, 1994. tar, but still Tobacco P., June, pp. 22-24, a lot of nicotine. D. E. The Press, 1996. York Times, 5. Benowitz, N. L., Jacob, P., III, Slade, J., and Yu, L. Nicotine content Eclipse nicotine delivery device. Am. J. Public Health, 87: 1865-1866, of the 1997. 6. DeBethizy. J. D., Borgerding, M. F., Doolittle, 0. J., Robinson, J. H., McManus, K. T., Rahn, C. A., Davis, R. A., Burger, G. T.. Hayes, J. R., Reynolds, J. R., IV, and Hayes, A. W. Chemical and biological studies of a cigarette that heats rather than bums tobacco. J. Clin. Pharmacol., 30: 755-763, 1990. 7. 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