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BEFORE THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ENVIRONMENTAL TOBACCO SMOKE: A GUIDE TO WORKPLACE SMOKING POLICIES EPA/400/6-90/004 RESPONSE OF R.J. REYNOLDS TOBACCO COMPANY OCTOBER 1, 1990 VOLUME I

TABLE OF CONTENTS I. INTRODUCTION ............................................. 1 II. RESPONSE ........................................... ..... 6 A. The Authors Of The Policy Guide Are Biased And Have Conflicts Of Interest ................................................ 6 B. The Policy Guide Presents A Selective, Distorted And Misleading Review Of ETS Science .................................... 7 1. ETS Is Not Equivalent To Sidestream Cigarette Smoke ....... 8 2. Constituents Of ETS Provide No Basis To Reach Conclusions Regarding ETS And Health .......................... 11 a. Carbon Monoxide ............................. 15 b. Hydrogen Cyanide ............................ 17 c. Ammonia ................................... 17 d. Nicotine .................................... 18 e. Summary ................................... 19 3. The Policy Guide Trivializes The Complexities Of Exposure Assessment ....................................... 19 a. Air Monitoring - RSP ......................... 20 b. Air Monitoring - Nicotine ...................... 23 c. Air Monitoring - Dynamics ..................... 25 d. Biomarkers - Cotinine ......................... 27 i. Dietary Nicotine ......................... 28 ii. Cotinine Measurement Errors ............... 29 e. Other Surrogates ............................. 31 f. Questionnaires ............................... 33 g. Mathematical Models .......................... 33 4. The Purported Relationship Between ETS And Certain Health Effects Is Dubious .................................. 35 a. Irritation .................................... 35 b. Lung Cancer .................................. 37 i

c. Spurious Health-Effect Claims .................... 39 i. Children ......... . . . . . . . . . . . . . . . . . . . . . . 39 ii. Asthma, Heart Disease, Allergies And Other Cancers ............................... 39 C. Smoking Bans Do Not Effectively Address Indoor Air Quality Problems .............................................. 41 D. The Guide Should Objectively Discuss The Entire Range Of Possible Workplace Policies, Not Just Extreme Options .................. 44 E. Discussion Of Litigation, Economics And Public Opinion Is Extraneous And One-Sided ......................................... 47 F. The Policy Guide Should Be Based On Substantial Evidence ....... 49 G. The Policy Guide Is An Inappropriate Exercise Of Authority By EPA ................................................. 50 III. CONCLUSION .............................................. 52 REFERENCES ................................................... 53 11

BEFORE THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ENVIRONMENTAL TOBACCO SMOKE: ) A GUIDE TO WORKPLACE SMOKING ) FR DOC. 90-20013 POLICIES ) RESPONSE TO THE EPA PUBLIC REVIEW DRAFT DOCUMENT: "ENVIRONMENTAL TOBACCO SMOKE: A GUIDE TO WORKPLACE SMOKING POLICIES" SUBMITTED BY: R. J. REYNOLDS TOBACCO COMPANY I. INTRODUCTION On June 25, 1990, the Environmental Protection Agency (the "EPA" or the "Agency") released a draft document titled Environmental Tobacco Smoke: a Guide to Workplace Smoking Policies, EPA/400/6-90/004 (Public Review Draft) (the "Policy Guide" or "Guide"). By Federal Register Notice, dated June 25, 1990, the EPA solicited comments regarding the "manner in which EPA characterizes in this document the scientific information available on environmental tobacco smoke" [Federal Register, 19901. The Notice also states that the Agency wants to ensure that the Policy Guide does not oversimplify the state of scientific knowledge on environmental tobacco smoke (ETS). R. J. Reynolds Tobacco Company ('RJRT' or the "Company") submits this response to address the scientific accuracy, the presentation of scientific information, and the policy implications of the Guide.' I Appended to this Response are individual comments, prepared by scientists of RJRT's Research and Development Department. Specific technical inaccuracies, mischaracterizations, omissions and oversimplifications are addressed by these scientists according to their area of expertise. 1

Addressing these concerns is hindered by the Guide's gross oversimplification of ETS science. This gross oversimplification results in both lost accuracy and incompleteness. The Guide presents as fact (i) inaccurate scientific arguments, (ii) assertions which are technically correct, but altogether irrelevant to a discussion of ETS and (iii) statements that portray a one-sided, selective view of current scientific understanding. The Guide's inadequate presentation of the science may be partially attributed to the scarcity of credible ETS research related to health. In a recent review of ETS and health, Mahajan commented that "no other aspect of the tobacco and health issue has had more shoddy research and less reproducible results published" [Mahajan, 1990, p. 87]. The Guide has unfortunately relied upon much of this shoddy research, but has ignored many well-conducted studies that are relevant to an evaluation of ETS in the context of indoor air quality. This selective review of the science apparently is designed to justify predetermined policy conclusions. The EPA states that "[t]he Guide to Workplace Smoking Policies is intended to provide government -and private sector decision makers with information on the technical basis for controlling involuntary nonsmoker exposure to environmental tobacco smoke and to describe the range of technical and policy options for instituting effective smoking policies" [Federal Register, 1990]. To accomplish this goal, the Guide must present an accurate, objective and complete review of ETS science. The Guide must also present a comprehensive and objective discussion of all policy options available to decision- makers - including the option of no formal smoking policy. The Guide falls far short of the EPA's intended goals, and thus the EPA does not meet its obligations to decision-makers. 2

In a peculiar abrogation of Agency responsibility, the EPA retained outside contractors, Robert Rosner and Robin Simons of the Smoking Policy Institute (the "Institute"), to develop the Guide. Rosner and Simons have indisputable vested interests that raise questions about their objectivity. They and their Institute stand to benefit significantly if employers follow the limited options promoted by the Guide - options that would enjoy the EPA's imprimatur if the Guide were finalized in its present form. Agency employees have strict conflict of interest guidelines. The involvement of these outside authors is wholly inappropriate and raises the question of impropriety. The EPA was established to provide a neutral, objective forum for the evaluation of science and for the development of national policy. This Guide does not meet even minimal standards of objectivity and accuracy. The Guide incorrectly presumes that ETS is a proven cause of lung cancer. The authors present as established fact conclusions drawn from the Agency's draft document: Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratoty Disorders in Children, EPA 1600/6-90/006A (the "Health Assessment") - now under initial review. The authors leap from a superficial review of the Health Assessment and other federal government documents [NRC,1986; USPHS, 1986] to conclude that ETS causes lung cancer. Despite the Guide's many summary statements, ETS has not been proven to cause lung cancer in nonsmokers.2 Many scientists have reached conclusions contrary to the Agency [Adlkofer, 1989; Layard, 1990; Letzel, 1988; Thornton, 1989; Uberla, 1988; Uberla, 2 RJRrs position is described fully in comments on the Health Assessment submitted to the Agency separately and attached to these comments. 3

1987; Wynder, 1990]. Neither the Health Assessment nor any other review has presented a persuasive case that ETS is an unconfounded risk factor for lung cancer in nonsmokers -- let alone that there is a causal relationship. It is an abuse of discretion for the Guide to be based on preliminary and questionable findings contained in the Health Assessment. The Guide selectively reviews and incorrectly characterizes ETS scientific literature. Many important studies are ignored; others are distorted or overinterpreted. For example, studies presenting real-world concentrations of ETS constituents are omitted [Carson, 1988; Crouse, 1990; Crouse, 1989; Oldaker, 1990a; Oldaker, 1990b; Oldaker, 1986; Sterling, T., 1988] and limitations regarding ETS exposure measurements are ignored. Most troubling, the Guide blurs the distinction among ETS, mainstream smoke (MS) and sidestream smoke (SS). The result is a distorted perspective of ETS science. In short, the Guide presents a quasi-scientific apologia to justify predetermined, but unfounded, policy positions. The policy recommendations rest upon this flimsy scientific foundation. The Guide emphasizes two extreme policy options - a total ban on smoking in the workplace and the construction of specially designed, separately ventilated rooms. Logically, these two policies follow directly from the EPA's assumptions that ETS is a proven cause of lung cancer in nonsmokers and that no safe exposure level exists' The Guide, however, fails to inform the reader of the uncertainties pervading these assumptions. The failure to discuss other options can withstand scrutiny only if these assumptions are correct. Different assumptions would suggest different policy preferences. The Guide's recommendations fail to satisfy the EPA's ' The Company does not offer a detailed critique of the presumption of no threshold limits for carcinogens because the Agency has failed to demonstrate that ET'S is a carcinogen. 4

stated goal: "to describe the range of technical and policy options for instituting effective smoking policies" [Federal Register, 1990]. The promotion of extreme policy choices based on uncertain and questionable assumptions raises serious questions about the EPA's objectivity. Finally, the EPA has exceeded its authority by developing the Guide. The Guide constitutes de facto rulemaking. The Occupational Safety and Health Administration (OSHA) is the only federal agency with authority to regulate exposures to substances found in the workplace. The EPA's justification for its Policy Guide is based upon a companion Health Assessment which itself is arbitrary and capricious and an abuse of the Agency's discretion. RJRT's response is presented in seven sections.' Section A describes the bias of the Guide's principal authors. Section B examines the Guide's treatment of the science of ETS. Section C describes the role of ETS in indoor air quality. Section D considers the extreme policy options presented in the Guide and describes several others that should be included. Section E discusses the EPA's resort to extraneous information to buttress its rationale that extreme workplace smoking policies are necessary. Section F discusses EPA's lack of substantial evidence upon which to base the Guide's conclusions and recommendations. Finally, Section G explains that the Guide is an inappropriate exercise of authority by the EPA. ' This response is not a line-by-line correction of the Guide. That type of response could only be made effectively if the Guide contained only minimal errors amenable to correction. 5

II. RESPONSE A. The Authors Of T6e Policy Guide Are Biased And Have Conflicts Of Interest The primary authors of the Policy Guide are Robert Rosner and Robin Simons of the Smoking Policy Institute (the "Institute") in Seattle, Washington. A review of the Institute's mission and Rosner's activities reveals bias and conflict of interest. Although billed as a non-profit organization, the Institute, which began in the University of Washington's School of Business, routinely consults with companies to "eliminate smoking in the workplace" [Estill, 1988]. In addition, the Institute develops and markets materials produced by the Bureau of Business Practice, a division of Simon and Schuster. Rosner, whose antipathy for cigarette smoking is well-known, is the director of the Institute. He has publicly voiced strong antismoking sentiments that preclude any objectivity in drafting a smoking policy guide [e.g., Estill, 1988]. As early as 1982, smoking cessation featured prominently in his social agenda [Reynolds, 1990]. In 1984, Rosner established the consulting firm of Rosner, Weiss, and Lowenberg to assist private employers with the development and implementation of workplace smoking policies [Oates, 1985]. Rosner continued his antismoking efforts as Executive Director of the Institute for Occupational Smoking Policy [Greene, 1985]. Today, Rosner remains very active in promoting smoke-free workplaces [Reynolds, 1990]. Despite the name of his organization, or its tax-exempt status, the business of Rosner's Institute is to create an environment in which employers and employees feel a need for workplace smoking restrictions and then to cater to that perceived need. Rosner 6

personally consults with such commercial groups as "Smoke-Stoppers" and assists them in promoting smoking-cessation seminars to corporations. As Rosner aptly noted, the "pitch" for corporate clients makes economic sense for him and for the companies he represents: "Getting together a room full of strangers requires extensive ads, but if you get one hit at a company, you can make $2,000 with 12 people in the room" [Hammer, 1988, p. 42]. The Guide is tantamount to a vehicle for promoting additional interest among private employers to institute smoking policies. In fact, it reads more like a marketing brochure than a policy guide. Rosner has publicly stated his belief and hope that "[i]f widely adopted, these [workplace smoking] policies might have a dramatic effect on the nation's smoking habits. Theoretically, they would encourage people to quit smoking by increasing the social pressure against it and by restricting the time available for it" [Martin, 1986, p. 647]. The potential benefits of the Guide to Rosner and his Institute are obvious. The EPA would not permit agency personnel with such clear conflicts of interest to draft policy. The same standard should be expected of EPA contractors. B. The Policy Guide Presents A Selective, Distorted And Misleading Review Of ETS Science The scientific evaluation that forms the basis for the recommendations in any government policy guide should be accurate, complete, impartial and appropriate for a non- technical audience. The Guide should not represent to the public as established fact assertions that are the subject of substantial disagreement in the scientific community. It also should clearly identify points of scientific debate and questionable assumptions. Furthermore, the Guide should present information about ETS within the greater context of indoor air quality, rather than singling out ETS. 7