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CRITIQUE OF THE DRAFT REPORT ENTITLED Environmental Tobacco Smoke: A Gui e to Workplace Smoking Policies U.S. Environmental Protection Agency Chapters 1 - 2 Prepared by: Mark J. Reasor, Ph.D. I received B.S. (1967) and M.A. (1969) degrees in Biochemistry from Purdue and Duke Universities, respectively. After receiving a Ph.D. degree in Biochemical Toxicology from The Johns Hopkins University in 1975, I performed postdoctoral work in pharmacology at the National Institute of Environmental Health Sciences in North Carolina. I then -became an Assistant Professor of Pharmacology and Toxicology at West Virginia University in 1976, and achieved tenure at that institution in 1984. I am certified in general toxicology by the American Board of Toxicology. Since 1969, I have published 69 research articles in the fields of pharmacology and toxicology. I am an Editorial Board member of Toxicology and Applied Pharmacology, an official journal of the Society of Toxicology, and Indoor Environment and am an Associate Editor of the Journal of Toxicology and Environmental Health. I have published one book chapter and one review article on environmental tobacco smoke: (1) Biological markers in assessing exposure to environmental tobacco smoke. In: Environmental Tobacco Smoke: Proceedings of the International Symposium at McGill University (D. Ecobichon and J.M. Wu, eds.), Lexington Books, Lexington, MA,

2 pp. 69-77, 1990; (2) The composition and dynamics of environmental tobacco smoke. J. Environ. Health 50:20-24, 1987. A copy of my curriculum vitae is attached. I have been asked to review Chapters 1 and 2 of an EPA draft document on environmental tobacco smoke intended for use as a guide for workplace smoking policies. CHAPTER 1 -- WHAT I S ETS? I. General Comments Chapter I of the draft workplace smoking guide presents an inaccurate, misleading and simplistic descriptiorn of ETS that does not provide a balanced view of the scientific literature in this field. EPA appears to have relied entirely on other agencies to evaluate the relevant literature and has accepted those opinions without a critical evaluation of its own. Many of the citations for statements relating to properties of ETS are to other government documents (National Research Council, 1986; US Surgeon General, 1986; US Surgeon General, 1989) rather than to the primary research publications. Because EPA has not conducted an objective and comprehensive review of the primary literature, it is not surprising that the document presents untenable generaliza- tions and draws unfounded conclusions. First, the document portrays ETS as equivalent to the well-characterized sidestream smoke (SS) (Eatough et al. 1990), giving the false impression that ETS itself is as well-characterized. The fact that SS is not the same chemical or physical entity as ETS (Reasor, 1987; National Research

3 Council, 1986) has been completely obscured. The characteristics ascribed to SS in this chapter are relevant only when the material is freshly generated and undiluted. They are not representative of ETS, a substance composed of variable amounts of SS and exhaled mainstream smoke in proportions dependent on individual smoking patterns. ETS is a far more dynamic material than SS; its properties are not the same from moment to moment (Eatough et al. 1990). The properties of ETS are influenced significantly by a number of considerations, including smoker density and environmental factors such as dilution, volume of the room, ventilation, temperature, humidity, lighting, and adsorption onto surfaces. An example of these influences is the effect of ventilation on the decay rate of components of ETS (Baker et al. 1988). The half-times for the decay of selected components as a function of air exchange rate are in the order NO2 > CO = CO2 > NO = total hydrocarbons > particulate matter > nicotine. Additionally, chemical reactions and physical changes occur in ETS, altering its composition. For instance, a significaht fraction of the particulate material evaporates, with the loss of water and volatile organic compounds, resulting in a reduction in particle size (Pritchard et al. 1988). Particle coagulation has been observed to occur under these conditions (Eatough et al. 1990). Nitric oxide is converted into nitrogen dioxide (Benner et al. 1989), and free

- 4 - radicals are quenched with time (Sonnenfeld et al. 1985). The significance of these factors is not addressed in Chapter 1. The physical and chemical changes, known as aging, that occur as ETS lingers indoors contribute significantly to the complexity and dynamic nature of ETS (Eatough et al. 1990). The composition of ETS will be different depending on conditions that exist at any given time. As a result, little consistent information exists on the characteristics of ETS under ambient conditions in indoor environments that would allow generalizations such as those the EPA has made about its composition. Without a discussion of the aging process and . its effect on ETS, it is not possible to gain an understanding of the true characteristics of ETS. Another inaccurate impression given in this chapter is that ETS contains more toxic and carcinogenic chemicals than mainstream smoke (MS). In addition to being insuffi- ciently characterized to allow accurate determination of its composition, ETS is far more dilute than MS. Consequently, an individual exposed to ETS will inhale substantially lower levels of chemicals than an active smoker inhaling MS. The description of the potential toxicity of constituents of MS, such as carbon monoxide, hydrogen cyanide, ammonia and nicotine, relate, if at all, only to acute exposure to high levels. There is no evidence, however, that these effects could be attributable to levels associated with ETS exposure. In fact, quantitative levels of these materials in ETS are not known. One reason for this is that background

5 levels of the chemicals confound attempts to quantitatively ascribe them to ETS. Except for nicotine, none is specific to tobacco smoke. In fact, a number of chemicals, including the tobacco-specific nitrosamines, have not been detected in ETS. The document also suggests that the deposition patterns of ETS and MS in the lungs are different, with ETS depositing in the alveolar region of the lungs and MS depositing mainly in the mouth and larger airways. There is no information available detailing the deposition profile of ETS, and no reference is provided supporting the claims for MS. In fact, this statement is incons stent with the EPA's own estimate of MS particle deposition in the draft of Health Effects of Passive Smoking: Cancer in Adults and Respiratory Disorders in Children where it is estimated that 60% of the inhaled dose of particles from MS (80% of the retained dose) deposits in the alveolar region (EPA, 1990). Lastly, it is misleading to generalize that the chemicals in ETS remain in the body longer than those of MS in active smokers. While it has been suggested that this may be true for nicotine (Haley et al. 1989), which in any case is present in body fluids of nonsmokers exposed to ETS at a fraction of the levels in active smokers (Jarvis et al. 1989), no similar information exists for other chemicals. In presenting a one-sided and superficial discus- sion, the EPA has failed in its stated goal of accurately ~ describing what ETS is ~ . .A GJi

6 II. Specific Comments by Section INTRODUCTION EPA-Statement (p. 7): For the average smoker, approximately 55% o the cigarette is burned between puffs, making sidestream smoke the largest constituent. Comment: The value cited was determined using standardize smoking machines and does not reflect the wide variation in smoking patterns of active smokers (Hoffmann et al. 1983). EPA Statement (p. 7): Together, the particles in the particulate an gas phases of ETS contain over 4,000 chemicals, at least 43 of which are known carcinogens. Comment: These values arise from what is known about mainstream smoke, and it is not valid to extrapolate these figures to ETS. A comprehensive chemical composition analysis of ETS has not been performed; therefore, it is not known how many chemicals or carcinogens may be present in ETS. DIFFERENCES BETWEEN MAINSTREAM AND SIDESTRFAM SMOKE Particle Size EPA Statement (p. 7): Particles in MS are deposited mainly in the mouth an larger airways of the smoker's lungs. Comment: This statement is inconsistent with what EPA is report-ing n its draft risk assessment (EPA, 1990). Particles in the size range described for mainstream smoke would be expected to be deposited in the alveolar region of lungs (Stuart 1976). EPA Statement p. 7: .. the chemicals circulate widely in the o y, ten ing to remain in the body longer than mainstream smoke in active smokers. Comment: This is a misleading and inaccurate statement. The only chemical for which data exist is nicotine, and its metabolism appears to be slower in nonsmokers compared to smokers. There is no basis for generalizations to other chemicals. Chemical Make-Op EPA Statement (2. 8): Sidestream smoke contains more toxic a-ncr-carcinogenic chemicals than mainstream smoke * * * . Comment: These statements are based on information from sidestream smoke generated using standardized smoking machines. Smoking patterns differ among active smokers (Hoffmann et al. 1983), so it is inappropriate to make comparisons between sidestream and mainstream smoke. More importantly, it should be emphasized that what is relevant is the composition of ETS, and not sidestream smoke. Dilution,

7 ventilation, and the other factors associated with aging will reduce the levels of chemicals in ETS to a fraction of the levels in mainstream smoke. EPA Statement (p. 8): The tar and nicotine sidestream yields do not decrease proportionately with the cigarette mainstream yields. This means that manufacturers' efforts to reduce tar and nicotine consumption for smokers by introducing filtered and low-tar, low-nicotine cigarettes, has not reduced involuntary exposure to these chemicals. In some cases, it may have actually increased it. Comment: There is no support for the proposition that the a vent o filtered, low-tar, or low-nicotine cigarettes has increased involuntary exposure to tar or nicotine nor does the report cite any. The Table appended to this chapter purports to show that total miligrams of tar in sidestream smoke increased with the use of a particular filter. However, it is impossible to assess the accuracy of this assertion because the number of cigarettes analyzed is too few to draw conclusions and the table does not reference an underlying study or primary literature. Moreover, even if_ one accepts the accuracy of the Table, it could be concluded that total tar and nicotine in sidestream smoke actually decreases with the use of a filter. Finally, the report continues to err in equating assertions about sidestream smoke with ETS. OTHER CONTAMINANTS EPA Statement (~. 8): "[I]t is fairly certain that commercial to accos contain up to a few parts per million of DDT, DDD, and maleic hydrazide; fewer than 20 percent of these contaminants are transferred into the smoke stream." Comment: This statement comes from the 1989 US Surgeon General 1-s report where no primary literature is cited to support these conclusions. Therefore, there is no basis for their inclusion in this report. HAZARDOUS CONSTITUENTS IN ETS Carcinogens and Mutagens EPA Statement (p. 8): ETS has both (carcinogens and mutagens]. Comment: This statement misrepresents the facts. Concentrate extracts of ETS have been reported to be mutagenic in bacterial systems, but these collection conditions are not representative of ETS as breathed by the nonsmoker. ETS has never been shown to be mutagenic or carcinogenic at levels that exist under ambient conditions. EPA Statement (Q. 8): Of the 99 compounds in tobacco smoke that have been studied in detail, at least 43 are complete carcinogens, each able on its own to cause the development of cancer in humans or animals. Other ETS constituents are tumor initiators, capable of carrying out the

8 first step in cancer development. Still others are tumor promoters, able to accelerate the development of cancer. Comment: There is no evidence that any of the chemicals re to be carcinogens are able to cause cancer at the low levels to which nonsmokers are exposed. EPA Statement (p. 9): ETS also contains chemicals that are co-carcinogens, able to cause cancer when combined with another substance. It contains cancer precursors, compounds that pave the way for the formation in the body of other carcinogenic chemicals. And it contains other compounds that damage the cilia, or cleansing hairs, of the lungs, making them less able to clear the lungs of deposited tars. This allows cancer-causing chemicals to remain. Comment: Again, this paragraph is a misrepresentatio of the facts about ETS. At the levels occurring in ETS, there is no evidence that chemicals will be effective in the carcinogenic process. ETS has never been shown to damage cilia in the airways of the lungs; therefore, it is inaccurate to insinuate that the inhalation of ETS will impair the clearance of particles which will allow cancer-causing chemicals to remain. EPA Statement (p. 9): In his 1979 report, the Surgeon General cites 27 known tumor initiators, three groups of tumor promoters, and 18 compounds that are co-carcinogens as known components of tobacco smoke. Comment: This statement relates to mainstream smoke and is not app ical ble to ETS. The compounds alluded to have not been shown to be capable of functioning in ETS in the roles described. EPA Statement (p. 9): Sidestream smoke is known to have signi icantly higher concentrations of carcinogens and mutagens than mainstream smoke. For example, the tumor initiators N-nitrosamines are found in quantities up to 100 times greater in sidestream smoke. Comment: It is misleading to present information on sidestream smoke as if it directly relates to ETS. The two materials are different entities and should not be treated as interchangeable. EPA Statement . 9: Chemical analysis of the smoke from pipes, cigars an cigarettes indicates that carcinogens are found in similar levels in each. Experimental studies have shown that smoke condensates from pipes and cigars are equally, if not more, carcinogenic than those from cigarettes. Comment: This statement pertains to mainstream smoke and ispplicable to ETS. This citation comes from the 1989 US Surgeon General's report; no primary literature is cited to support this conclusion. Therefore, there is no basis for its inclusion in this report.

9 Toxins and Irritants EPA Statement (p. 9): In addition to its carcinogenic constituents, ETS contains a variety of other chemicals that are harmful to humans. Examples include: ...Carbon monoxide, Hydrogen cyanide, Ammonia, and Nicotine. Comment: The toxicities described for these chemicals apply only under conditions of high exposure. The levels to which nonsmokers would be exposed would be expected to be far below the OSHA permissible exposure limits. Of the chemicals listed, the levels of carbon monoxide have been well-characterized under conditions where smoking has occurred and are not significantly elevated compared to nonsmoking areas (Proctor et al. 1989; Sterling and Mueller 1988). For example, Sterling and Mueller (1988) found levels of carbon monoxide (OSHA PEL = 35 ppm) to be below 4 ppm in areas where smoking was permitted. Therefore, to present toxicities in this manner without the qualification of exposure level is misleading. Additionally, the chemicals listed, including nicotine, are not specific for ETS. There is now evidence that nicotine is a normal constituent of several vegetables including tomatoes, green peppers and potatoes (Castro and Monji 1986; Sheen 1988). Therefore, exposure to these chemicals will occur from non-tobacco sources, a fact that has not been addressed in this chapter.

- 10 - References Baker RR, Case PD, and Warren ND. The build-up and decay of environmental tobacco smoke constituents as a function of room conditions. Indoor and Ambient Air Quality, Perry R and Kirk RW, eds. Selper, LonUo_n, pp. 121-129, 1988. Benner CL, Bayona JM, Caka FM, Tang H, Lewis L, Crawford J, Lamb JD, Lee ML, Lewis EA, Hansen LD, and Eatough DJ. Chemical composition of environmental tobacco smoke. 2. Particulate-phase compounds. Environ. Sci. Technol. 23:688-698, 1989. Castro A and Monji N. Dietary nicotine and its significance in studies on tobacco smoking. Biochem. Arch. 2:91-97, 1986. Eatough DJ, Hansen Lb, and Lewis EA. The chemical characteri- zation of environmental tobacco smoke. in Environmental Tobacco Smoke, Proceedings of the Int=o-nationa Symposium at McGill Universit 1989, Ecobichon DJ and Wu JM, eds, Lexington Books, DC Heath and Co., Lexington, Mass., pp. 3-50, 1990. EPA, Health Effects of Passive Smokin : Cancer in Adults and Respiratory Disorders in Children, Dra t Review, p. C-28, 1990. Haley NJ, Sepkovic DW, and Hoffmann D. Elimination of cotinine from body fluids: Disposition in smokers and nonsmokers. Amer. J. Public Health 79:1046-1048, 1989. Hoffmann D, Adams JD, and Haley NJ. Reported cigarette smoke values: a closer look. Amer. J. Public Health 73:1050-1053, 1983. Jarvis MJ. Application of biochemical intake markers to passive smoking measurement and risk estimation. Mutation Res. 222:101-110, 1989. National Research Council, Environmental Tobacco Smoke- Measuring Exposures and Assessing Health Effects, National Academy Press, Washington, DC, pp. 25-53, 198 . Proctor CJ, Warren ND, and Bevan MAY. Measurements of environmental tobacco smoke in an air-conditioned office building. in: Present and future of indoor air ualit . Bieva CJ, Courtois and Govaerts M., eds. Elsevier Science Q9 Publishers, Amsterdam, 1989, pp 169-172. Pritchard JN, Black A, McAughey JJ. The physical behaviour of sidestream smoke under ambient conditions. Environ. Technol. Letters 9:545-552, 1988.