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September 27, 1990 Comments on the Draft EPA Document Environmental Tobacco Smoke A Guide to Workplace Smoking Policies by Trent R. Lewis, Ph.D. I have been asked by The Tobacco Institute to comment on the draft document entitled "Environmental Tobacco Smoke: A Guide to Workplace Smoking Policies." I am currently a private consultant on occupational, environmental and toxicologic issues. I received a Ph.D. from Michigan State University in 1961 in animal nutrition with minors in biochemistry, physiology and bacteriology. My professional career in toxicology began in 1963 as Chief, Chronic Exploratory Toxicology Unit with the National Air Pollution Control Administration, responsible for the development, design, conduct and supervision of toxicologic studies addressing health hazards posed by air pollutants, notably those generated by automotive emissions. From 1971-1987, I was employed by the National Institute for Occupational Safety and Health, initially as Chief, Acute and 7 Subacute Toxicology Section, and in 1907 as Chief, Experimental Toxicology Branch, Division of Biomedical and Behavioral Science. From 1987 to 1989, I was employed at EPA as Director, Toxicology and Microbiology Division, Health Effects Research Laboratory. During this period I conducted and supervised research and agency programs regarding health

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 2 hazards posed by toxic agents in the workplace and ambient air, soil and water, including automotive emissions, industrial ketones and 2-nitropropane. Through this professional experience, I have developed broad knowledge of environmental toxicology, risk assessment, and other approaches to determining safe levels of human exposures to chemical substances and agents, and the application of these disciplines to risk management and the development of regulatory policy. A complete description of my education, credentials and qualifications are included in my curriculum vitae, a copy of which is attached. Introduction In the Introduction to the draft Policy Guide, the sweeping statement is made that "ETS is one of the most widespread and harmful indoor air pollutants." In light of the available evidence, this conclusion appears wholly inaccurate. The National Institute for Occupational Safety and Health (Melius et al., 1984) and a private corporation, Healthy Buildings International, Inc. (Robertson, 1990), have investigated hundreds of public and private buildings in response to complaints by the occupants. In only two to three percent of these field investigations was environmental tobacco smoke ("ETS") found to be a major contributory factor to the air quality problems that had been identified.

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 3 The Introduction also states that "[u]nless there is evidence to the contrary, EPA believes that any exposure to a cancer causing agent -- regardless of level -- increases the risk of cancer." That fundamental premise is controversial and by no means generally accepted. It also is not sufficient to support the extraordinarily broad policy recommendations contained in the draft Guide. For reasons that are not explained, the draft fails to discuss the range of possible policies and management practices that might be adopted regarding ETS, and the actual costs and benefits of those actions. These cost-benefit considerations typically are the most important issues facing federal agencies in setting "acceptable" exposure limits for recognized human or animal carcinogens in air, food and water. A very substantial percentage of adult Americans are smokers. In setting policy that would affect the daily life of such a large segment of the public, and potentially cause dislocation and disruption in the workplace and public facilities, a balanced assessment of the range of policy options available and their costs/benefits is essential. Instead, the draft Guide appears to be driven by a generalized antipathy to smoking and a value judgment that the practice should be discouraged or eliminated regardless of exposure level or social cost. From the total weight of evidence available, it is . also premature, if not impossible, to conclude that ETS is a

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 4 occupational (workplace) carcinogen. The clear majority of the individual epidemiological studies have failed to demonstrate a statistically significant relative risk and those studies that were statistically significant were of non-U.S. populations with radically different cultures and lifestyles. Most significantly, the one substantial epidemiological study that has addressed workplace exposure to ETS has very recently reported "no evidence of an adverse effect of environmental tobacco smoke in the workplace." (Janerich, et. al., 1990). Part I: Environmental Tobacco Smoke: "The Problem" Although many comments could be made on technical points presented in Chapter 1, I will confine my comments to issues of particular relevance to my areas of expertise. First, it is inaccurate and misleading to suggest that substances originating from ETS and absorbed into the body tend to have a longer systemic residency time than identical substances drawn directly from mainstream smoke in active smokers (bottom p. 7). This difference has been reported only for nicotine (Haley et al., 1989); no similar data exist for other chemical substances in mainstream smoke versus ETS. Second, "toxins and irritants" are inaccurately portrayed in the text and tabular formats (pp. 9-10). The title of the Table on page 10 is misleading to lay readers who may be led to believe that each chemical substance listed is both toxic and carcinogenic. Nicotine, carbon monoxide, catechol and

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 5 ammonia are not carcinogenic and are toxic only after exceeding a threshold concentration or dose. The same is true for hydrogen cyanide, which is referred to in the text. It is erroneous to present the toxicological descriptions for hydrogen cyanide and ammonia as written since there is no likelihood that the human effects stated would ever result from the minimal levels associated with exposure to ETS. I have similar comments with respect to Chapter 2. First, while it may be true that "many people spend up to 90% of their time indoors," people do not spend 100% of their indoor time at the worksite. Second, under "Defining Exposure," two separate definitions are provided for extent of exposure and dose. Only the latter -- dose -- is germane from a health or toxicologic perspective. Extent encompasses only the duration of exposure, whereas dose encompasses both the duration of exposure and the amount of a substance that is inhaled and retained. Third, page 13 describes benzene as a "surrogate" for ETS that can be hazardous to those exposed to ETS. In fact it is neither. The principal source of exposure to benzene is petroleum-based materials, notably gasoline and refined petroleum solvents. There is no evidence from smokers or nonsmokers that benzene, at the miniscule concentrations found in ETS, has induced leukemia or blood dyscrasias, the major chronic health hazards posed by benzene.

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 6 Part II. Environmental Tobacco Smoke: "The Solution" Consistent with the tone set in the Introduction, Part II gives an unbalanced and exaggerated picture of ETS in relation to the general problem of poor indoor air quality in U.S. workplaces. NIOSH (1984) found that almost 80% of indoor air quality problems were related to three primary factors other than ETS. The first of these was inadequate ventilation; this dominant component accounted for 48% of the problems. The second factor, accounting for 18% of the problems, was exposure to a toxic substance originating from sources related to equipment or specific workpractices within the building (e.g., copy machines, use of pesticides, humidification agents, or cleaning supplies). The third major problem, identified in 11% of the investigations, was contamination from sources external to the building, (e.g., motor vehicle exhaust, boiler gases, previously exhausted air, and construction dust). In only 4 of 203 investigations was ETS found to play a role in the symptoms experienced by complainants. Likewise, Healthy Buildings International, Inc. (Robertson, 1990) found ETS to be a major contributing factor in only 2% of its investigations. From these data, the obvious conclusion is that the elimination of ETS from worksites will have a very minor impact on improving indoor ~ air quality even in buildings where air quality problems have ~ ~ been identified. ~ GD G11

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 7 By focusing undue attention on ETS, the draft Policy Guide neglects the single most important step that can be taken to ensure healthy workplace air quality: provide adequate ventilation (NIOSH, 1984; Robertson, 1990). The American Society of Heating, Refrigeration and Air Conditioning Engineers (ASHRAE, 1989) recommends a ventilation rate of 20 cfm per person (with 15 cfm as an absolute minimum) for offices, and higher rates for high emission locations, such as printing and copying rooms. In the industrial setting, supplemental ventilation may be required to reduce industrial emissions, including local exhaust ventilation where necessary. The draft Policy Guide as written may well have the effect of delaying compliance with ASHRAE standards by portraying smoking prohibitions as a "cure-all" for indoor air quality. Part III: Case Studies Part III's discussion of workplace smoking policies and "case studies" is limited to offices and public buildings and likewise appears to be premised on the assumption that, contrary to results of the studies discussed above, ETS is the sole source of indoor air problems in those settings. The Chapter also simply ignores the fact that industrial settings present air quality problems that are broader in scope and often more environmentally complex and severe than office locations. As with Part.II, the mistaken premise of Part III

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 8 appears to be that prohibition of smoking is a "magic solution" to indoor air quality. Conclusion The overall impression created by the draft Policy Guide is that elimination of ETS would effectively cure nearly all indoor air quality problems. Yet the available data indicate that, when specific instances of known problems are investigated, ETS plays an insignificant role. Exposure to the specific compounds cited by the draft Policy Guide in relation to ETS, such as polycyclic aromatic hydrocarbons and nitrosamines, is also well known to result from occupational environments (coking operations, foundry casting, diesel engines, etc.), office environments (printing and copying equipment, off-gassing by furnishings), residential environments (cooking and heating), and the ambient air (vehicle exhaust, fossil fuel power plants, etc.) The draft Policy Guide relies on inadequate data to make an incorrect and unjustifiable policy statement that prohibition of smoking in the workplace is the solution to indoor air quality problems. The unfortunate result may well be that remedial steps addressing serious exposures to known hazards (in contrast to ETS) are deferred or ignored.

Response to the Draft EPA document ETS: Guide to Workplace Smoking Policies Trent R. Lewis, Ph.D. Page 9 References 1. U.S. Environmental Protection Agency, Health Effects of Passive Smokin : Assessment of Lun Cancer in A ults and Res irator Disorders in Children Review Dra t, EPA 600 6-90 006A, 1990. 2. Melius, J. Wallingford, K., Keenlyside, R., & Carpenter, J. Indoor air quality--the NIOSH experience. Ann. Am. Conf. Gov. Ind. Hyg. 10: 3-7, 1984. 3. Robertson, G., Indoor pollution: sources, effects and mitigation strategies. In Environmental Tobacco Smoke, Proceedings of the International Symposium at McGill Univer is ty 1989. Ecobichon, D.J. & Wu, J.M., eds. Lexington Books, D.C. Health and Co., Lexington, MA, pp, 333-355, 1990. 4. Janerich, D., et. al., Lung Cancer and Exposure to Tobacco Smoke in the Household, N. Engl. J. Med. 323: 632-6, 1990. 5. Haley, N.J., Sepkovic, D.W., & Hoffman, D., Elimination of cotinine from body fluids: Disposition in smokers and nonsmokers. Amer. J. of Public Health 79: 1046-1048, 1989. 6. American Society of Heating, Refrigeration, & Air Conditioning Engineers, Standard 62-1989. Ventilation for acceptable indoor air quality, 1989.