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Comments on: ENVIRONMENTAL TOBACCO SMOKE: A GUIDE TO WORKPLACE SMOKING POLICIES [Dratt] EPA 400/6-90/004 Response Addressing: Chapter 1: What Is ETS? Table (page 10): "Toxic and Cancer Causing Agents in Mainstream and Sidestream Cigarette Smoke" Topic: Nitrosoamines Prepared by: James M. Conner Associate R&D Technologist R.J. Reynolds Tobacco Company October 1990

SUMMARY: The draft document Environmental Tobacco Smoke: A Guide To Workplace Smoking Policies (the "Policy Guide" or the "Guide") contains misleading and incorrect information. N-Nitrosamines are not unique to tobacco smoke; they are derived from a variety of sources. The mainstream and sidestream smoke concentrations reported in the Poliry Guide for N-nitrosamines are suspect. Moreover, volatile nitrosamines, but not tobacco specific nitrosamines, have never been detected in environments containing realistic levels of ETS. COMMENTARY: N-Nitrosamines are ubiquitous, being derived from a variety of sources. For example, N-nitrosodimethylamine (NDMA) has been detected in such sources as: diesel engine exhausts, rubber and leather industry products, interior fabrics of new cars, beer and cooked bacon.[1,2] Tobacco smoke is reported to contain tobacco-specific (TSNA) and non tobacco-specific N-nitrosamines. NDMA, N-nitrosodiethylamine (NDEA) and N- nitrosopyrrolidine (NPYR) are volatile N-nitrosamines; both are derived from many sources other than tobacco smoke. N-Nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3- pyridyl)-1-butanone (NNK) are TSNA. On page 9 of the Policy Guide, the authors state that amounts of N-nitrosamines are 100 times greater for sidestream (SS) compared with mainstream (MS) smoke. This statement is especially misleading for TSNA. Data in the literature and in the table on page 10 of the Guide indicate that for NNN and NNK the ratios of sidestream to mainstream concentrations are 1 to 1 and 3 to 1, respectively. [3-7] Furthermore, SS/MS ratios for NPYR and NNN for nonfiltered cigarettes calculated from the concentrations listed in the table on page 10 and listed in Table C-2 of the EPA's

document: "Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children" (the "Health Assessment") are inconsistent. For example, the SS/MS ratio for NNN calculated from the Guide's Table is approximately 1-1. However, Table C-2 of the rtealth Assessment indicates that the ratio is 2-1 which (given the reported mainstream concentration) would indicate that the sidestream concentration of NNN for a nonfiltered cigarette is 3000 ng. per cigarette. This value is more than three times greater than any NNN sidestream concentrations reported for non-filtered cigarettes.[3-7] The concentrations of mainstream and sidestream smoke N-nitrosamines in the Policy Guide's Table are suspect. The concentration units reported for N-nitrosopyrrolidine should be "nanograms (ng) per cigarette" not "milligrams (mg)." Recent analytical data indicate that the concentration of N-nitrosamines listed in the Guide's Table are biased high. Caldwell and Conner [3] found that N-nitrosamines formed artifactually in cigarette smoke trapping methods previously reported for N-nitrosamine determination. These earlier methods therefore result in high values for concentrations in mainstream and sidestream smoke of volatile and tobacco-specific N-nitrosamines: e.g., using the smoke trapping procedures of Hoffmann et al.[8,9] NNK in sidestream smoke was 56% higher and NPYR in mainstream smoke was 380% higher than with the Caldwell and Conner method. [3] Significantly, Concentrations reported in the Guide's Table (originally from Adams St pl. [7]) are for mainstream and sidestream smoke, NOT for ETS. Concentrations for TSNA in ETS are not listed because none has been detected!' The few studies describing I Some questionable values for NNN and NNK were reported in a poster presentation given in 1987 at a time when the analytical methodology for tobacco-specific nitrosamines in ETS was not well defined. These concentrations were given as < 1-6 2

N-nitrosamines in ETS list results for NDMA, NDEA and NPYR concentrations only. Investigators who measured the levels of volatile N-nitrosamines in indoor air environments containing ETS note that sources other than cigarette smoke contributed to the detected levels, and that the relative contribution from ETS is unknown. [5,10] RECOMMENDATION: The authors should correct the inaccuracies contained in the Guide's Table. Further, they should indicate that tobacco-specific n-nitrosamines have never been confirmed in ETS. (The sole questionable citation occurred in a non-peer-reviewed conference poster.) The authors should also state that other n-nitrosamines have never been attributed to ETS. ng/m' for NNN and <2-11 ng/m' for NNK. These data and supporting experimental procedures have not been published in a refereed journal, although the data were ~ cited by Adlkofer.[11] ~ ~ C+1 3 8

References (1) Spiegelhalder, B., & Preussmann, R. (1983) Analysis of airborne n-nitrosamines: general aspects and sampling strategies. In "Environmental Carcinogens Selected Methods of Analysis N-Nitroso Compounds," Egan, H., Preussamnn, R., O'Neill, I.K., Eisenbrand, G., Spiegelhalder, B., and Bartsch, H., (Eds), Scientific Publication No.45, IARC, Lyon, France, pp.41-43. (2) Gray, J.I. (1983) Formation of N-nitroso compounds in foods. In "N-Nitroso Compounds Am. Chem. Soc. Symp. Ser." Scanlan, R.A., & Tannenbaum, S.R., (Eds), 174, pp. 165-180. (3) Caldwell, W.S. & Conner J.M. (1990), Artifact formation during smoke trapping. An improved method for the determination of N-nitrosamines in cigarette smoke. J. Assoc. Off. Anal. Chem. in press. (4) Adams, J.D., Brunnemann, K.D., & Hoffmann, D. (1983), Chemical studies on tobacco smoke. J. Chromatogr. 256, 347-35 1. (5) Hoffmann, D., Brunnemann, K.D., Adams, J.D.,& Hecht, S.S. (1983). Formation and analysis of N-nitrosamines in tobacco products and their endogenous formation in consumers. In Proceedings of 8th International Symposium N-Nitroso Compounds, pp. 743-762. Banff, Canada. (6) Fischer, S. & Spiegelhalder, B. (1989) Improved method for the determination of tobacco-specific nitrosamines in tobacco smoke. Beitr. Tabakforsch.Int. 14, 145-153. (7) Adams, J.D., O'Mara-Adams, K.J. & Hoffmann, D. (1987) Toxic and carcinogenic agents in undiluted mainstream smoke and sidestream smoke of different types of cigarettes. Carcinogenesis 8, 729-731. (8) Hoffmann, D., Brunnemann, IGD., & Webb, K.S. (1983) Volatile nitrosamines in tobacco and mainstream and sidestream smoke and indoor environments. In "Environmental Carcinogens Selected Methods of Analysis, N-Nitroso Compounds," Egan, H., Preussmann, R., O'Nedl, LK., Eisenbrand, G., Spiegelhalder, B., and Bartsch, H., (Eds), Scientific Publication No. 45, IARC, Lyon, France, pp.69-83. (9) Hecht, S.S. , Adams, J.D., & Hoffmann, D. (1983) Tobacco - specific nitrosamines in tobacco and tobacco smoke. In "Environmental Carcinogens Selected Nethods of Analysis, N-Nitroso Compounds," Egan, H., Preussmann, R., O'Neill, LK., Eisenbrand, G., Spiegelhalder, B., and Bartsch, H., (Eds), Scientific Publication No. 45, IARC, Lyon, France, pp. 93-101. (10) Stehlik, G., Richter, O., & Altman, H. (1982) Concentration of Dimethylnitrosamine 4

in the air of smoked-filled rooms. Ecotoxicology and Environmental Safety 6, 495- 500. (11) Adlkofer, F.X., Scherer, G., Von Meyerinck, L, Von Maltzan, C., & Jarczyk, L (1989) Exposure to ETS and its biological effects: A review. In "Present and Future of Indoor Air Quality," Bieva, CJ., Courtois, Y., and Govaerts, M., (Eds), Excerpta Medica, Amsterdam, pp. 183-196. 5