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Michael W. Ogden, Ph.D. R. J. Reynolds Tobacco Co. Research & Development P.O. Box 1236 Winston-Salem, NC 27102-1236 Telephone: 91 Q-741-5787 Facsimile: 910-741-5019 E-mail: ogdenm@qrt_com June 10, 1997 MINUTES OF CORESTA'S ETS SUB-GROUP MEETING Paris, France April 23-24, 1997 Attendees: Jan Arnarp, Takuya Asai, Michael Bevan, Hoy Bohanon, Barrie Frost, Michael Intorp, Katherine Maiolo, Takumi Nishina, Michael Ogden, Tatsuya Ono, Henri Papenfus, Jean- Jacques Piade, Stephen Purkis, I-Ielmut Reif, Mooz Soo Rhee, Yves Sai_nt-Talm, Ted Sanders, Joaquin Sarabia, Gerhard Scherer, Matthias Schorp, Stephen Sears Introduction Mike OGDEN welcomed participants and thanked SEITA and Yves SAINT-JALM, in particular, for organizing the meeting. The 21 Sub-Group members present signed the attendance list and received the agenda (attached as Appendix 1). CORESTA Competition Law Compliance Policy The CORESTA policy was reviewed regarding the need for compliance with all applicable laws relating to the prevention, restriction or distortion of competition. The policy applies to all CORESTA activities, including those of the Sub-Group. Questions or concerns about the policy or compliance should be directed to members of the Scientific Commission or the Board. Smoke/Techno Group Meeting in Hamburg Participants were reminded of the upcoming,joint meeting of the Smoke & Technology Study Groups in Hamburg, Germany from 8-11 September, 1997. Meeting announcement and abstract forms were circulated. Modification of ETS Sub-Group Objectives Following the recommendation of the Convenor, and approval by the Scientific Commission and the Board, the ETS Sub-Group objectives were modified and are as follows: • To develop CORESTA Recommended Methods for the following ETS constituents: RSP, UVPM, FPM, solanesol, and 3-ethenylpyridine ~ • To update the existing CORESTA Recommended Method for nicotine in ETS c.~ o~ • To study the effectiveness of ventilation and design of various smoking locations. ~ o! Cn ~ In addition, the following request was approved: ~ tn

• To include laboratories of the following non-CORESTA members in the final collaborative testing'af the methods being developed: Oak Ridge National Laboratory, Oak Ridge, Tennessee, USA; Covance Laboratories, Inc., Harrogate, England; and Axion Analytical Laboratories, Chicago, Illinois, USA. The following objective was requested as a new work item, was tentatively approved by the Scientific Commission, but was rejected by the Board as being outside the current scope of CORESTA activities (however the Board encouraged individual Companies studying this topic to give presentations of their findings at CORESTA meetings): • To investigate the technical problems associated with the use of cotinine as a biomarker of ETS exposure. Ventilation Study Progress Participants in the Ventilation Study held a working meeting on April 23 organized and chaired by Hoy BOHANON. Others in attendance were: Takuya ASAI, Barrie FROST, Katherine MAIOLO, Takumi NISHINA, Mike OGDEN, Jean-Jacques PIADE', Helmut REIF, Moon Soo RHEE, Yves SAINT-JALM, Ted SANDERS, and Matthias SCHORP. Technical details in the areas of data interpretation and statistical treatment were discussed at this working group meeting and summarized for the main Sub- Group meeting. Summaries of the experimental protocol and preliminary results were given for each country studied: England (Barrie FROST); France (Yves SAINT-JALM); Japan (Takuya ASAI); Korea (Moon Soo RHEE); Switzerland (Jean-Jacques PIADE'); USA (Hoy BOHANON). Objectives and attributes of the study were summarized as follows: to increase our understanding of ETS in real-world restaurant environments and to serve as a range-finding experiment for the restaurant environment both in terms of concentrations of ETS markers and occupant acceptability. Preliminary conclusions are: there are a number of positive public-relations-type messages contained within the data from each country; protocol differences among countries may preclude exhaustive data analyses; and each country's survey provided a wealth of complicated data and information. Next steps are to focus on determining how data from individual surveys can be combined and what types of data treatments will be the most effective. Collaborative Study Progress Mike OGDEN provided an updated list of laboratories (attached as Appendix 2) agreeing to participate in the planned collaborative testing of the ETS methods. Progress has been slow over the past year; the final collaborative test cannot be scheduled until all participants have set up and validated the test methods in their labs. To provide momentum and assistance in this regard, an ETS Analytical Methods Workshop was conducted by Mike OGDEN and Katherine MAIOLO on April 22 in the Munich laboratory of Gerhard SCHERER. Scientists from most of the participating labs were able to participate. General discussion ensued on three points central to the Sub-Group's goals of establishing CORESTA Recommended Methods: (1) re-evaluating the usefulness of the UVPM and FPM methods for estimating ETS contribution to RSP; (2) establishing the particle size median cut-point for defining respirable particles; and (3) deciding whether or not to include individual labs in the sample collection phase of the study (as opposed to just participating in the laboratory analyses). On point (I), there was discussion and a general difference of opinion on whether or not the UVPM and FPM apportionment methods continue to be useful methods in light of the generally more accurate solanesol method. Specific examples of cases where UVPM overestimated total RSP were discussed. The prevailing opinion seemed to be that, since no single method could be guaranteed of providing the

scientifically correct answer in every case, there would be a greater sense of certainty in field work by continuing to include as many different measures as possible and drawing conclusions based on the convergence of the data (when possible) rather than on individual end-points. Several good ideas were brought forward for the Sub-Group's consideration in dealing with this issue: (a) there continues to be a need for more ETS markers with more specificity for ETS and further work in this area could be undertaken by the Sub-Group; (b) the Sub-Group could consider preparing a Guide illustrating how to go about selecting which markers to measure and how to interpret the results of those measurements (similar to a Guide which M. OGDEN and K. MAIOLO have been requested by the American Society for Testing and Materials to prepare); (c) the Sub-Group could conduct experiments to better elucidate the sources and source strengths of non-ETS UVPM and FPM responses; and (d) at a minimum, the Sub- Group must be vigilant in describing within the standard methods the limitations of all potential ETS markers, including UVPM and FPM. Regarding (2) above, there was discussion around what the definition of "respirable" should be in the context of respirable suspended particles (RSP). The American standards and the ISO new work item on RSP/UVPM/FPM define RSP as particles passing a size-separation device which has a median cut-point of 4 µm. However, arguments could be made for a smaller median cut-poir.t (2.5 Nin) or a larger median cut-point (10 µm). Obviously, existing standards or recommendations within ISO are likely to prevail; however, the Sub-Group agreed to research the definitions of RSP used in individual member countries. The specific task is to determine the official position of government, regulatory, and scientific organizations regarding the cut-point diameters, the shape of any recommended or required cut-point curves (if known), any specified devices required to give such a particle size definition, and any specific recommendations (or differences in recommendations) for indoor air, outdoor air, or workplace air. Volunteers from the following countries agreed to gather this information and return it to Mike OGDEN before September 1, 1997: Korea (Moon Soo RHEE); Germany (Gerhard SCHERER); Switzerland (Matthias SCHORP); UK (Barrie FROST); USA (Katherine MAIOLO); Sweden (Jan ARNARP); Japan (Takuya ASAI); France (Yves SAINT-JALM); and Spain (Joaquin SARABIA). {Sub-Group members from other countries who were not in attendance at the meeting are encouraged to provide this information as we1I.} Regarding (3) above, there was discussion about the merits of including each collaborative study participant in the sample collection phase of the study. The tentative study design calls for all samples to be collected by RJR scientists in the environmental chambers in Winston-Salem. However, it was recognized that this may not give a true reflection of the total variance in the methods, since different persons collecting their own samples (i.e., providing their own sampling and measuring equipment, measuring pump flow rates, etc.) may introduce additional variability. In general, there are advantages and disadvantages both ways; however, due to the significant costs that participants would incur by hav ing to purchase their own sampling pumps and travel to the sa.-nple collection site, it was f lt that the original plan was a reasonable compromise. Michael INTORP agreed to check within ISO for any guidance in this area (i.e., collaborative testing of just the analysis method when the full technical standard includes sampling as well). ASTM/ISO Update Activities within the American Society for Testing and Materials (ASTM) and within ISO were summarized as follows: ~ • ASTM D5075, "Standard test method for nicotine and 3-ethenylpyridine in indoor air", has been ~ accepted and published. cri • ASTM D5955, "Standard test methods for estimating contribution of environmental tobacco smoke r_n to respirable suspended particles based on UVPM and FPM", has been accepted and published. N ~

• An ASTM draft method, "Standard test method for estimating the contribution of environmental tobacco smoke to respirable suspended particles based on solanesol", has been prepared and will be submitted to ASTM for voting by July 1. The 20th Plenary Meeting of ISO Technical Committee (TC) 126 (Tobacco and Tobacco Products) met 14-17 October, 1996 in Williamsburg, Virginia, USA; the following resolutions were drafted: • The Draft International Standard, ISO/DIS 11454 "Tobacco and Tobacco Products-Determination of Vapour-Phase Nicotine in Air-Gas-Chromatographic Method", was approved and will be published without change, other than editorial, as an International Standard. (This Standard is technically the same as CORESTA Recommended Method 14). • ISO/TC 126 N 554, "Environmental Tobacco Smoke-Estimation of the Contribution to Respirable Suspended Particles-Ultraviolet Absorbance and Fluorescence Methods", was accepted as a new work item. (Mike OGDEN was confirmed as project leader for this work item). Technical Presentations The following general technical presentations were given: • "Numerical Simulations and Experiments on the Transport of Fine Particles in a Ventilated Room" by Takuya ASAI. Key conclusions were that numerical calculation reproduced air flow velocity well and that calculations could predict particle distributions quantitatively except near the room walls. • "ETS Extraction in a Motor Car" by Mike BEVAN. Objectives were to determine levels of ETS in a motor car with and without ventilation and to provide effective removal of the smoke through a novel extraction/ventilation system. • Due to time constraints, the last two presentations ("ETS Exposure of Smokers Relative to Nonsmokers" and "Use of Cigarette Equivalents in Assessing Exposure to ETS" by Mike OGDEN) were not given; however, reprints of the recent journal articles were distributed. Other Business Steve SEARS provided an update on the SCOTH committee progress in the UK. The long-anticipated report to the committee by Nicholas WALD is not available for review as yet. Apparently, WALD is experiencing delays in getting the report peer-reviewed. Expectations are that the report will be available by the end of the summer. The approach being taken by WALD apparently is an attempt to calculate ETS risk potential through the use of cigarette equivalents based on cotinine. Next Meeting It was agreed that a half-day meeting of the ETS Sub-Group would be arranged in conjunction with the SmokerTechno meeting in Hamburg in September. Details of the meeting place and time will be mailed to Sub-Group members in advance of that meeting. Respectfully submitted, a Michael W. Ogden, Convenor ~ ~ 00

Appendix I AGENDA CORESTA ETS SUB-GROUP MEETING April 23-24, 1997 Hotel Le Meridien Montparnasse Paris, France (Hosted by SEITA) Thursday, April 24 09: 00 - Sub-group Meeting (Jacob Room) 1. Welcome 2. Sub-group Business - M. Ogden • CORESTA Competition Law Compliance Policy • SmokelTechno Group Meeting - Hamburg • Modification of Sub-group Objectives 3. Report on Ventilation Study Progress - H. Bohanon • Individual Survey Reports (by country) • England • France • Japan • Korea • Switzerland • USA • Review of Sampling Strategy and Analysis Methodology • Discussion & Next Steps 12: 30 - Lunch (Restaurant Justine) 4. Report on Collaborative Study Progress - M. Ogden • Review of Participating Labor:.Lories • ETS Analytical Methods Workshop • ASTM/ISO Update • Discussion & Next Steps 5. General Technical Presentations • Numerical Simulations and Experiments on the Transport of Fine Particles in a V entilated Room - T. Asai • ETS Extraction in a Motor Car - M. Bevan • ETS Exposure of Smokers Relative to Nonsmokers - M. Ogden • Use of Cigarette Equivalents in Assessing Exposure to ETS - M. Ogden 6. New Business 7. Date and Place of Next Meeting -17: 00 - Adjourn

Appendix 2 LABORATORY (CONTACT PERSON) N1C 3-EP RSP SOL UVPM FPM R. J. Reynolds (Mike Ogden) ® 0 ® ® ~ ® Philip Morris- Neuchatel (J-J Piade) 0 0 0 0 0 ® Rothmans (Barrie Frost) 0 0 0 0 0 0 Tabacalera (Joaquin Sarabia) 0 0 0 & JTI (Takuya Asai) 0 0 0 0 0 Reemtsma (Michael Intorp) ® 0 0 0 0 0 ABF Miinchen (Gerhard Scherer) 0 ® & 0 ® ® SEITA (Yves Saint-Jalm) 0 0 ® ® ® KGTRI (Moon Soo Rhee) 0 0 0 0 0 ® Covance (Keith Phillips) 0 0 ® ® ® ® Oak Ridge National Lab. (Roger Jenkins) 0 & 0 0 0 0 Axion Analytical (Lee Polite) 0 0 0 0 & 0 TOTAL NUMBER OF LABS* 12 12 11 12 11 10 *Minimum number of labs desired is l Q; Absolute minimum for ISO is 8 OZZT99690Z