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f PROTOCOL FOR , ~_ UV 7 ~ ~J / --"' EVALUATION OF REDUCTION IN ETS IN REAL-LIFE SITUATIONS BY SMOKING TOBACCO-HEATING RATHER THAN TOBACCO-BURNING CIGARETTES Prepared by Charles Green Hoy Bohanon Paul Nelson Mike Ogden David Taylor Research & Development Department and Environmental Affairs Department R. J. Reynolds Tobacco Company August 17, 1995 ~ ~ ~ a

FT~ ~ TABLE OF CONTENTS 1. Executive Summary . . . . . . . . . . . . . . . ..... .. .. . . . . . . . . ..... .. . . . . . . . . .. ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. B ackground ....... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ 2 3. Project Objectives ............................................................:....................................... .... 3 4. Description of Project .................................................................................................. 3 5. Site .................................................................................................... .......................... 3 6. Subjects .................................................................................................... ................... 4 6.1 Patrons .................................................................................................... .............. 4 6.2 Employees .................................................................................................... ......... 4 6.3 Visitors .................................................................................................... .............. 5 7. Description of Procedure for Selecting Sampling Spaces .............................................. 5 8. Procedure for Selecting Sampling Locations in Spaces ................................................. 5 8.1 Breathing Zone ............. ................................................................ . . ..... .. ... . . .. .. .. . .. .. 5 8.2 Ventilation . . .. . . . . . . .. . . ..... . . . . . . . . . . .. ..... .. . . . . .. ..... .. . . . . . . . . ..... . . .. .. . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . 5 8.3 Sidestream or Mainstream Smoke Sources ............................................................. 5 8.4 Occupant Behavior ................................................................................................ 5 8.5 Number of Sampling Points and Replicates ............................................................ 5 8.6 Blanks .................................................................................................... ............... 6 9. Qualitative Assessment of HVAC System .................................................................... 6 9.1 Inspection .................................................................................................... .......... 6 9.1.1 Cleanliness, operation, and structural integrity ................................................. 6 9.1.2 Adequacy ofthe HVAC system's design .......................................................... 6 10. Determination of Outside Air Quality ......................................................................... 6 10.1 RSP .................................................................................................... ................. 6 10.2 UVPM .................................................................................................... ............. 6 10.3 FPM .................................................................................................... ................ 7 10.4 S olanesol . . . . . . . . . . . . . . . ... . . . . . . . . . . . . .. .. . .. .. . . . . . . ..... .. . . . . . . . . . . . . .. ... . . .. .. .. . ... .. .. . . .. .. .. . . .. . . . . . . .. . . . . 7 10.5 Carbon Monoxide ................................................................................................ 7 10.6 Carbon Dioxide .............. ................................................................................... ... 7 10.7 Temperature and Relative Humidity ..................................................................... 7 10.8 VOC's (OPTIONAL) .......................................................................................... 8 11. Determination of Indoor Air Quality .......................................................................... 8 11.1 Time Integrated Samples ...................................................................................... 8 11.1.1 RSP .................................................................................................... .......... 8 11.1.2 UVPM .................................................................................................... ...... 8 11.1.3 FPM .................................................................................................... ......... 8 11.1.4 Solanesol .................................................................................................... .. 9 11.1.5 Nicotine .................................................................................................... .... 9 11.1.6 3-Ethenylpyridine (3-EP) ............................................................................... 9 11.1.7 VOC's (OPTIONAL) .................................................................................... 9 11.2 Real-Time Samples .............................................................................................. 9 11.2.1 Carbon Monoxide ......................................................................................... 9 11.2.2 Carbon Dioxide ............................................................................................. 9 11

F T ~ O D ~o 11.2.3 Temperature and Relative Humidity ............................................................ 10 11.2.4 Bruel and Kjxr (B&K) Model 1303 Multipoint Sampling System ................ 10 11.2.5 TEOM Measurement .................................................................................. 10 11.3 Background Correction For RSP ....................................................................... 10 11.3.1 Discussion ................................................................................................... 10 11.3.2 Procedure For Background RSP Correction ................................................ 10 12. Determination of Smoking Activity .......................................................................... 11 13. Determination of Occupancy of Test Space .............................................................. 11 14. Determination of Quantity of Outside Air Supplied to Test Spaces ........................... 11 15. In oor Air Quality Questionnaire ............................................................................. 12 15.1 Patron Questionnaire ......................................................................................... 12 15.1.1 Smoking Status ........................................................................................... 12 15.1.2 Acceptability ............................................................................................... 12 15.1.3 Rating ......... ................................................................................................ 12 15.1.3.1 Rating of odor ...................................................................................... 13 15.1.3.2 Rating of eye burn ................................................................................ 13 15.1.3.3 Rating of amount of smoke in the air (haze) .......................................... 13 15.2 Employee Questionnaire .................................................................................... 13 15.2.1 Acceptability ............................................................................................... 13 15.2.2 Rating .................................................................................................... ..... 13 15.2.2.1 Rating of odor ...................................................................................... 13 15.2.2.2 Rating of eye burn ................................................................................ 13 15.2.2.3 Rating of amount of smoke in the air (haze) .......................................... 13 15.3 Visitor Questionnaire (optional) ......................................................................... 13 15.3.1 Acceptability ............................................................................................... 13 15.3.2 Rating ..................... .................................................................................... 13 15.3.2.1 On a scale of 1 to 10 with 1 being none and 10 being the worst situation you've ever encountered, please rate the following :............................................ 13 15.3.2.2 Rating of odor ...................................................................................... 13 15.3.2.3 Rating of eye burn ................................................................................ 13 15.3.2.4 Rating of amount of smoke in the air (haze) .......................................... 13 16. S CHEDULING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 16.1 Site Select .................................................................................................... ...... 14 16.2 HVAC Documentation And Ventilation ............................................................. 14 16.3 Control Of Facility ............................................................................................. 14 iu

1. Executive Summary Tobacco-heating cigarettes produce much less environmental tobacco smoke (ETS) when smoked than t -burning cigarettes. Quantification of the specific amount of reduction i est done n very controlled environments such as R. J. Reynolds ETS smoking rooms. These exacting studies can best isolate and control unwanted variables, e.g., number of smokers, ventilation, smoking location, etc., so that the comparison between tobacco-heating and tobacco-burning product is both accurate and precise. However, the question has been raised concerning differences in ETS concentrations generated in real-life situations such as restaurants, bars, offices, homes, etc., by totally replacing the smoking of tobacco-burning cigarettes with smoking of tobacco-heating cigarettes. Because extraneous variables are extremely difficult to control in real-life situations, design of these comparisons is difficult; perfection is never achieved. This document describes a design for a real-life study in restaurants/bars. Relative minor modifications would be necessary for application to other environments. 1

2. Background It is apparent from the construction differences between tobacco-heating and tobacco- burning cigarettes that the yields of ETS should be quite different. This observation has been documented for an earlier tobacco-heating cigarette, PREMIER.' In the quantification of ETS reduction for tobacco-heating cigarettes to a single number, some choices must be made because ETS is a multi-component mixture and no one marker compound is universally accepted. Based upon our knowledge of tobacco smoke chemistry and the alledged health effect from smoking or being exposued to ETS, we have decided that the sin~le r~st 9nnronriate constituent to quantify a eduction claim on is respirable suspended particles (RSP). RSP are particles with a diameter less than 3.5 µm. RSP is chosen as the species upon which to quantify an ETS reduction claim for the following reasons: • RSP is the smoke that people see. • These particles may be retained in the lung when breathing smoke.2 • Chemically, and presumably biologically, these particles are approximately equivalent to the material described as FTC "tar." • Reduction of other controversial compounds in ETS will be quantified and made available to interested parties.3 Per cent reduction of ETS resulting from smoking tobacco-heating rather than tobacco-burning cigarettes can be either more or less depending on the marker used for comparison. Our assessment of using RSP to quantify ETS reduction when comparing tobacco-heating vs. tobacco-burning cigarettes is in concordance with the following statement from the National Research Council:4 The RSP fraction of ETS is currently the best and most-utilized general category of air contaminants to represent ETS exposure. ' R. J. Reynolds Tobacco Company, 1988. New Cigarette Prototypes That Heat Instead Of Burn Tobacco, Sections 4.5 & 4.6, "Chemical Composition 0 New Cigarette Smoke, Characterization of Sidestream Smoke and Environmental Tobacco Smoke Investigations," 154-169, published by R. J. Reynolds Tobacco Co., Winston-Salem, NC 27102. 2 Mc Aughey, J. J., Knight, D. A., Black, A., and Dickens, C. J., 1994. Environmental Tobacco Smoke Retention In Humans From Measurements Of Exhaled Smoke Composition, Inhalation Toxicology, 6(6), 615-631, and references therein. 3 In many instances, the concentrations of controversial compounds in ETS are too low for reliable quantification. For these cases, sidestream smoke analysis will be substituted for ETS measurements. 4 National Research Council, 1986. Environmental Tobacco Smoke, Measuring Exposures andAssessing Health Effects, Committee on Passive Smoking, Board on Environmental Studies and Toxicology, National Academy Press, Washington, D.C., p. 95. 2

4Zp,F T 6 a D ~l 4 Studies to quantify the reduction of ETS due to smoking tobacco-heating cigarettes are best conducted in very controlled circumstances wherein extraneous variable such as number of smokers, number of products smoked, ventilation, duration of smoking, etc. are controlled. Even in these controlled situations, the use of human smokers to generate ETS adds an element of variablility. These studies are being conducted in smoking rooms located in the R. J. Reynolds Tobacco Company R&D complex. Beyond these standardized comparisons, several observers have asked for quantification of their own experiences while smoking and/or observing other people smoke tobacco- heating cigarettes. Specifically, they observe much less smoke in the air when tobacco- heating cigarettes are smoked in real-life situations. The challenge we have been asked to undertake is, can we quantify these observations? With the foreknowlege that extraneous variables are much more difficult to control is real-life situations, this protocol is our best judgement on how to design a scientifically valid study in a restaurant and/or bar environment. Modifications to this protocol may be necessary for studying other environments, e.g., offices, homes, automobile, etc. 3. Project Objectives The objectives of this study are the following: • To select an appropriate location for conducting a comparison of ETS generated by smoking tobacco-heating vs. tobacco-burning cigarettes. • To generate comparable levels of ETS in a real-life situation. • To determine observed smoking rate. • To characterize the HVAC system at the test site. • To assess relative concentrations of ETS present in the selected space. • To determine differences in indoor air quality as judged by occupants, visitors, and employees. • To develop data appropriate for scientific publication. 4. Description of Project The quantification of differences in ETS generated in a restaurant/bar setting by requiring smokers to smoke either tobacco-heating or tobacco-burning cigarettes on two separate occassions will be attempted. This study will require a co-operating restaurant available for our control on 2 separate days. On one day, all smokers will be allowed to smoke tobacco-burning cigarettes; on the other day, all smokers will be required to smoke tobacco-heating product. The factors to be studies are smoking amount, smoking rate, ETS concentration, opinions of patrons, visitors, and employees. 5. Site Site selection is critical for the success of this experiment. It is not critical because of any failure to reduce ETS levels by smoking tobacco-heating product rather than tobacco- 3

r D v.b'~i a y~ burning product, but because the levels of ETS from tobacco-burning cigarettes is very low in places that have adequate ventilation, i.e., meet ASHRAE 62-1989 guidelines. In adequately ventilated sites, we would be attempting to measure the difference between a small level vs. a very small level, an unreliable analytical chemistry task. The specific needs for the site of this study are the following: • The HVAC system brings little or no in outside air. • No air filtration devices for removing tobacco smoke from the air are installed. • Avoidance of locations near construction sites, major highways, parking garages is preferable. • Restaurants that cook food on open grills or barbeque meat are not suitable. • A single level floor plan is preferable. • Hoy please feel free to add others Once selected, the physical dimensions of the site should be recorded. The building HVAC systems and their operation should also be recorded. Photographs of the site would be helpful. 6. Subjects 6.1 Patrons There are 2 options: the same patrons both nights or different patrons on each night. The most valid comparison would result from using the same patrons on both nights. An alternative would be to quantify the chance patrons on the tobacco-burning night and attempt to match that population on the second, tobacco-heating, night. In either instance, the following criteria should be met: • As closely as possible, the same number of smokers and nonsmokers should be present. • Smokers should represent at least 1/3 of the patrons, preferably more. • Patrons should not have a conflict of interest, e.g., company employees. • Patrons should be blind to the purpose of the test even though it might be obvious. • Smoking should be ad libidum. 6.2 Employees Any employees who are asked to fill out a questionnaire asking their opinion of the air quality should be present both nights of testing. The following criteria should be met: • As closely as possible, the same number should be present both nights. • Employees should not have a conflict of interest, e.g., spouse employed by R. J. Reynolds. • Employees should be blind to the purpose of the test even though it might be obvious. 4

6.3 Visitors A group of 10 paid volunteers having no conflict of interest with the study and blinded to the purpose should be recruited to visit the establishment on both nights of testing. During the mid-point of the test, individual members of the visitor panel should take an inconspicous walk through the test area and then be asked to fill out a questionnaire on their perception of the air quality. 7. Description of Procedure for Selecting Sampling Spaces Where restaurant/bars contain multiple spaces, the sampling spaces within the restaurant/bar shall be selected giving consideration to smoking activity, accessibility, owner's concerns, and how representative the space is of the overall bar environment. 8. Procedure for Selecting Sampling Locations in Spaces The guidelines below will be observed to select the specific points with the restaurant/bars where samples will be collected 8.1 Breathing Zone Sampling points will be within the "breathing zone," which is defined here as that region within an occupied space between planes 2 feet and six feet above the floor and more than 2 feet from the walls or fixed air-conditioning equipment. (This guideline defines a space, which, although smaller, is practically the same as ASHRAE's "occupied zone:" "the region within an occupied space between planes 3 and 72 in.... above the floor and more than 2 feet ... from the walls or fixed air-conditioning equipment.") 8.2 Ventilation Sampling points should not be susceptible to the direct influence of sources of ventilation. 8.3 Sidestream or Mainstream Smoke Sources Sampling points should not be susceptible to the direct influence of either sidestream or mainstream smoke. 8.4 Occupant Behavior Sampling points should be selected in order to minimize (to the extent practical) the effect of the sampling operation on the ordinary behavior of occupants in the selected spaces. 8.5 Number of Sampling Points and Replicates A minimum of 3 sampling points should be selected in each test location. Triplicate samples of at least 4 hrs. duration should be made for each time-integrated sample at each sampling point. 5

6- 8.6 Blanks Triplicate "closed-air" before opening. blanks should be collected preferable in the hours immediately The principal investigator and the bar manager will be collectively responsible for selecting the location within each space based upon their judgment of the criteria above. It is expected that typical locations will include the horizontal surfaces of tables or dividers. 9. Qualitative Assessment of HVAC System Mr. Hoy Bohanon will inspect the HVAC system to assess its operation and maintenance (O&M) status. This inspection is intended to provide qualitative information which will complement quantitative information from other tests. In addition, this assessment of O&M will respond in part to an issue raised in the ASHRAE Standard: 9.1 Inspection Inspection will include the following: 9.1.1 Cleanliness, operation, and structural integrity Assessment of the cleanliness, operation, and structural integrity of the internals of the HVAC systems; and 9.1.2 Adequacy of the HVAC system's design Assessment of the adequacy of the HVAC system's design and O&M to meet the indoor air quality requirements of ASHRAE 62-1989. 10. Determination of Outside Air Quality Dr. Michael Ogden, Mr. David Heavner, and Mr. David Taylor will be responsible for the determination of outside air quality. 10.1 RSP Concentrations of RSP will be determined by the method described by Conner et al. S Samples will be collected for at least four hours during testing. Air pumps and impactors will be operated at the highest feasible flow rate to collect the best quantifiable sample. 10.2 UVPM Concentrations of UVPM will be determined by the method described by Conner et a1.6 Samples will be collected for at least four hours during testing. 5 Conner, J. M., Oldaker, G. B., III, and Murphy, J. J., 1990. Method For Assessing The Contribution of Environmental Tobacco Smoke to Respirable Suspended Particles in Indoor Environments, Environmental Technology, Vo. 11, pp. 189-196. 6

a D ~ 10.3 FPM Concentrations of FPM will be determined by the method described by Ogden et al. 7 This analytical method utilizes the same sample as that collected for the determinations of RSP and UVPM described above. 10.4 Solanesol Concentrations of solanesol will be determined by the method described by Ogden et a1.8 This analytical method utilizes the same sample as that collected for the determinations of RSP and UVPM described above. 10.5 Carbon Monoxide Concentrations of CO will be determined with a Metrosonics aq-501 air quality monitor. Two-minute determinations will be made at three times during the test. These determinations will occur once prior to beginning indoor testing, once during the indoor testing and once following the indoor testing. The arithmetic mean of the three determinations will be reported as the daily concentration result. The monitor will be calibrated once before its use. The "minimum detectable reading" of the monitor is ?? ppm. Triplicate CO measurements should be made during determination of the "closed- air" blanks. 10.6 Carbon Dioxide Concentrations of CO2 will be determined with a Metrosonics aq-501 air quality monitor. Two-minute determinations will be made at three times during the testing. These determinations will occur once prior to beginning indoor testing, once during the indoor testing and once following the indoor testing. The arithmetic mean of the three determinations will be reported as the daily concentration result. 10.7 Temperature and Relative Humidity Temperature and relative humidity (RH) will be determined with a Metrosonics aq-501 air quality monitor. Two-minute determinations will be made at three times during the testing. These determinations will occur once prior to beginning indoor testing, once during the indoor testing and once following the indoor testing. 6 Conner, J. M., Oldaker, G. B., III, and Murphy, J. J., 1990. Method For Assessing The Contribution of Environmental Tobacco Smoke to Respirable Suspended Particles in Indoor Environments, Environmental Technology, Vo. 11, pp. 189-196. ' Ogden, M. W., K. C. Maiolo, G. B. Oldaker III, and F. W. Conrad, Jr., 1990. Evaluation of Methods for Estimating the Contribution of ETS to Respirable Suspended Particles, INDOOR AIR'90; Proceedings of the 5th International Conference on IndoorAir Quality and Climate, International Conference on Indoor Air Quality and Climate, Ottawa, Canada, 415-420. 8 Ogden, M. W. and K. C. Maiolo, 1989. Collection and Determination of Solanesol as a Tracer of Environmental Tobacco Smoke in Indoor Air, Environmental Science & Technology 23, 1148. 7