rubentito/OCR-IDL huggingface dataset:
NOTES/EXCERPTS FROM SANTA FE NEWSCLIPS April 2000, Associated Press: Santa Fe markets "Natural American Spirit" tobacco cigarettes and tobacco-free herbal cigarettes. The government alleged that the company tried to portray their cigarettes as safer with the claim that "Native Americans smoked all-natural tobacco without the ills that are associated with smoking today.' 1997. Indian Country Today: The company has also used testimonials in mail-order literature from customers claiming the cigarettes helped them quit smoking. It sent results of a survey to its customers which said the majority of American Spirit customers smoke less than their old brand, some as much as 50 to 70 percent less. Another document sent to customers were statements from Michio Kushi, who the literature called "America's leading Natural Foods teacher,' which said: "For centuries the North American Indians have smoked tobacco without developing cancer, and have utilized the plant for many medicinal purposes.' [comment from Michael Campbell, a lawyer for Santa Fe:] "We did not deny anywhere that nicotine is or is not addictive," he said. He also said Santa Fe Natural has not engaged in activities that some larger manufacturers are accused of doing, such as targeting children in advertising campaigns, or injecting additional nicotine into cigarettes to make them more addictive. Sept. 2001. Durham Herald-Sun: People for the Ethical Treatment of Animals has recognized Santa Fe Natural Tobacco Co., maker of Natural American Spirit additive-free tobacco products, for not testing its products on animals. "Santa Fe has clearly taken a step forward in the industry,' PETA spokesman Jay Kelly said Wednesday. "They deserve a pat on the back for this decision because it's a step that the largest cigarette companies like Phillip Morris and R.J. Reynolds have refused to take," he said Ron Tully, the company's vice-president of public affairs, said Santa Fe's policy is not new. The company even spells it out on its packaging. 1
June 2001, Santa Fe press release: As a small manufacturer, we depend on consumer-direct orders as an important means of reaching adult smokers who otherwise would be unaware of, or unable to obtain, our premium-quality product. While our volume of consumer-direct sales is small, we believe the ability to make such sales is important to our business and also contributes significantly to the success of the local retailers and distributors who have chosen to carry our product * Santa Fe has never allowed its products to be sold in vending machines, because of the difficulty of limiting access by minors to them. Santa Fe labels every pack of its cigarettes with the legend "Sale To Minors Prohibited," and was the first tobacco company to do so. * For many years, Santa Fe prohibited any sale of its products to or through chain stores because it lacked confidence that such mass merchandisers, who often displayed products on large, unattended customer self-service displays, could adequately prevent access by minors. Santa Fe only began selling to chain stores in the last four years, after federal regulations began to require retailers to request ID from any purchaser who appeared to be under 27 years of age. * Specifically with respect to direct orders from consumers, when the first direct order is placed by a consumer, Santa Fe requires a signed certification from that consumer that he or she is an adult, accompanied by a copy of that individual's driver's license or other government identification. Even though we have a product that is superior to that of the major commercial cigarette companies, a small company like Santa Fe Natural Tobacco Company simply cannot get its product on most retail shelves today because the major tobacco companies are buying up most of the available retail shelf space. Direct shipment to the consumer is an essential tool for us to be able to reach those adults who have chosen to smoke and offer them a high-quality alternative to traditional cigarettes. 0680 2
July 2001, Albuquerque Tribune: Santa Fe Natural now requires a proof of purchase from another brand, shipping fees and a copy of a driver's license. The company will ship only to the address on the license. "It is essential for us to have access to individually educate our customers about our products, one on one," he says. "That drives demand through the other channels, like retail. Without consumer direct sales, retailers won't get people saying, 'Guy, won't you carry this?" Since 1983, the company has sold "natural" cigarettes made with whole-leaf and not reconstituted tobacco, which does not contain stems, flavorings and humectants found in regular cigarettes. Smokers say the cigarettes taste better and last longer. All the tobacco for Santa Fe Natural's cigarettes is grown with a special proprietary process called purity residue clean tobacco. It may use some treatments, but the residue must be biodegradable by the time the tobacco is tested. The company has no plans to sell out to the bigger companies, despite rumors to that effect. "These rumors are engendered by those companies themselves," Sommers says. "If we were taken over by the majors, that would endanger our credibility." Sept. 2000, Charlotte Observer (Stella Hopkins story) John Travolta puffed American Spirits in the movie "Broken Arrow," and the additive- free -- but no safer -- cigarettes showed up on TV's "Seinfeld.' Photos show Leonardo di Caprio and Johnny Depp with the boutique butts. During a recent interview, Jerry Hall -- super model and Mick Jagger's ex, now playing "The Graduate's" Mrs. Robinson in London -- lighted up an American Spirit. The cigarettes, their wrappers printed with American Indian imagery, are the only ones sold at Rainbow Path, a Charlotte health food store. And the principal shareholder of the company making American Spirits is a nonsmoker who espouses a reverential approach to smoking and says people should smoke less in what he calls the "new age of smoking." "We're trying to create a whole new cultural mindset for the use of tobacco, where people realize they don't have to chain-smoke,' said Robin Sommers, chief executive of Santa Fe Natural Tobacco Co., based in its namesake city in New Mexico. "The message we've tried to impart is, use tobacco the way American Indians traditionally used tobacco." Santa Fe also pays farmers about twice the going rate for organically grown tobacco. Of course, growing organic is a lot more work -- hoeing and tending by hand, no easy chemical fixes for disease and bug infestations. 1980 3
Sept. 2000, Charlotte Observer (Stella Hopkins story -- continued) In addition to being additive-free, the cigarettes also use no fillers, such as stems, so they contain more tobacco. That means considerably higher levels of tar and nicotine. "People are going to smoke, I don't care what you do, so let's make the best product for people who have chosen to smoke or can't stop smoking,' Sommers said. "We look at ourselves as doing something quite meaningful in addition to the sheer capitalistic aspect.' There have never been American Spirit billboards. Santa Fe's promotional efforts don't include its version of Winston Cup racing, the Marlboro Man, Joe Camel or Virginia Slims babes. Santa Fe started with direct mailing to potential customers, hawking the cigarette as a link to tobacco's spiritual past with the American Indians. Black-and-white ads in alternative magazines such as Mother Earth News, Utne Reader and Whole Earth Review followed. The distinctive packaging -- an Indian in headdress, smoking a peace pipe - and the marketing tie-in to Indians' tobacco use has drawn criticism from Native Americans. "It's a company exploiting the imagery of Indians to promote a commercial product, which to Native Americans is sensitive because tobacco is spiritual,' said David Melmer, editor of Indian Country Today, a national weekly newspaper based in Rapid City, S.D. "It's exploiting the imagery of a stereotypical Indian rather than the Indian of today. "They don't want Indian people to be modern, to walk in today's world. They like to keep them in feathers and leathers because it makes everybody happy. It tends to hold a nation of people in the 19th century." Sommers dismisses claims that the brand offends Indians and says the company has good relations with the American Indian community. Through a separate foundation, the company donates 5 cents for every carton sold to Indian educational, cultural and arts groups. The company also is funding an endowment and gives cured tobacco leaf for use in Indian ceremonies. Packs of American Spirits say the cigarettes aren't any less hazardous than others. Still, public health officials have decried the additive-free marketing angle of American Spirits and similar brands as just a sales ploy -- and perhaps even more dangerous than more common advertising. With a market share of less than half a percent, Santa Fe is hardly a threat to Big Tobacco, although company officials like to take credit for what they see as mainstream limitators. They point to Winston-Salem-based R.J. Reynolds Tobacco's "No Bull" campaign for its additive-free Winston cigarettes and the burgeoning use of natural rather than synthetic menthol. 4
From the Santa Fe Website: The Pow-Wow Biend is a ceremonial pipe blend of additive-free, whole leaf, natural tobacco and the following pure herbs and botanicais: Sage, Red Willow, Bearberry, and Yerba Buena (spearmint). Natural American Spirit Pow- Wow Blend is packaged in patent-pending 40 gram, resealable pouches that feature an airtight zipper closure, which is designed to lock in the natural freshness of our additive-free tobacco. every time you close the pouch! June 2000, Tobacco Retailer: Santa Fe Natural Tobacco Company, Inc., based in Santa Fe, N.M., and Alternative Cigarettes, Inc., based in Buffalo, N.Y. have agreed to settle Federal Trade Commission charges that ads for their cigarettes are deceptive. Santa Fe markets Natural American Spirit tobacco cigarettes, and also sold tobacco-free herbal cigarettes. The FTC alleged that the two companies implied in their advertisements, without a reasonable basis, that their tobacco-containing cigarettes are safer to smoke than other cigarettes because they contain no additives Under separate settlements, which the FTC has accepted for public comment, the companies have agreed to disclose prominently in future ads that make a "no additives" claim: "No additives in our tobacco does NOT mean a safer cigarette.' " Both companies have also agreed to disclose prominently on packages and in ads for herbal cigarettes that: "Herbal cigarettes are dangerous to your health. They produce tar and carbon monoxide.' From the Santa Fe website FAO's: / understand you have had to withdraw your herbal cigarettes in the orange pack from the market. They were the best! Do you plan to make them available again? Non-tobacco Natural American Spirit Herbal Filter Cigarettes are not currently available, but we plan to re-introduce them in the coming months In late 1998, Santa Fe Natural Tobacco Company (SFNTC) agreed to join the Master Settlement Agreement negotiated by the major tobacco companies and the National Association of Attomeys General. This agreement was designed to settle numerous individual state lawsuits that had been brought against the major tobacco companies. While most small companies, such as SFNTC were not the target of these lawsuits, the provisions of the Master Settlement Agreement made it aimost impossible for small companies not to join the settlement. One provision of the settlement document prohibited tobacco companies from using a tobacco product brand name on a non-tobacco product. Accordingly, Natural American Spirit Herbal Cigarettes - which contained no tobacco - were withdrawn from the market. Currently, we are not able to give you an approximate timeframe for the re-introduction of our herbal cigarettes. However, we will inform all Natural American Spirit direct mail order customers, retailers, and distributors as soon as they are again available. 5
December 1998, Tobacco Retailer: Natural American Spirit introduces its first tobacco-free cigarette. The cigarettes, which contain cornsilk, yerba santa, licorice, mullein, coltsfoot and horebound, have been carefully blended to provide a soothing, satisfying smoke for people we do not wish to smoke tobacco. April 2000: Robin Sommers, president and chief executive officer of Santa Fe Natural, said in a written statement that the company voluntarily began placing a disclosure statement on its packages as early as 1997 but agreed to the changes requested by the FTC for the sake of uniformity on industry warning labels. "We do not agree that any of our past additive-free statements were deceptive or misleading in any way, Sommers said. "We believed at the time, and we continue to believe, that these statements are the most accurate, truthful tobacco disclosure statements in the industry." March 2000, Village Voice: The product logo--a smoking, head-dressed Native American--is meant to reflect the idea that "tobacco is a powerful herb worthy of the respect accorded it in Native American tradition," as the Santa Fe Web site describes it. All of which is not to doubt the organic credentials of the new smoke. Santa Fe's organic tobacco (which represents about 5 percent of all the tobacco the company sells) is grown according to certified organic standards, which means that the farming involves no chemical fertilizers or pesticides. There is little question that organic farming can benefit the earth. Rotating crops between fields ultimately improves soil fertility. And keeping chemicals out of the process protects wildlife, water, and soil. From the Santa Fe website - "customer testimonials": 1. The best tobacco in the world".St Callfornie 2. *I've enjoyed half my life as a smoker and have smoked many kinds of cigareties however. 1 never smoked a real cigarette until. I smoked Natural American Pennsylvania 3. TIve been a regular customer of SFNTC for about 4-5 years and I haven't found any other tobacco products that are of the same quality. or that truly live up to having only natural ingredents and no additivest" GH, Florida 4. "Excellent smoke, please keep it additive-free and naturali" -MJ. Colorado 5. "Thanks for beingi I ahways attempt to convert other smokers to Natural American Spirtt.°-DK. Connecticut 6. "American Spirits are the grentest cigarettest Many of my friends are converts."-SM North Carolina 7. "Good, 'straighr tasting smokel"-WR, Connecticut 8. "Your cigarettes are the best in the industryi"-AR, Connecticut 9. Natural American Spirit Cigarettes are the only cigarettes I smoke and they are the only ones I will continue to smoke ti I quitt"-JMP, Washington 10. Thank you for providing chemical-free tobacco. -MMC, Michigan 11. "Great product. this is the only sobacco - Pennsylvania 12. have tried plenty of cigareties - by far, your brand is THE best California 6
February 1995, Palm Beach Post: [American] Spirits are sold in smoke shops, newsstands, natural food stores and trendy cafes - including West Palm Beach's Little Eagle shop and Greene's Drug Store. And though no evidence exists - and the company doesn't claim - that Spirits are any less dangerous than mainstream cigarettes, they appeal to smokers turned on by a new-agey, alternative consciousness and who are concerned about their health, even if resigned to their addiction. The cigarettes sell well in such progressive cities as Seattle, San Francisco and Boulder, Colo., and in liberal college towns such as Madison, Wis., and Berkeley, Calif. And the company shows some concern for the environment; it wants to replace its papers, now made from flax fiber, calcium carbonate and citric acid, with unbleached cigarette papers. September 1998, Santa Fe New Mexican: The editors of Advertising Age magazine have honored Santa Fe Natural Tobacco Co. President and CEO Robin Sommers as one of the nation's 100 top marketers for establishing and repositioning the company's Natural American Spirit tobacco products. July 1998, World Tobacco: As a small producer, the company did not have the clout nor the capital to go into the same distribution channels as the mainstream tobacco products were in, nor did it really want to. Instead, in 1987, Mr Sommers used his experience of direct marketing, gained at Newsweek, to get through to his target market. Advertisements were placed in selected publications in the US aimed at those interested in spiritual and macrobiotic issues, and invited them to send for a sample of the product. From this small foundation, an increasing base of dedicated consumers was created. Distribution was then extended into health food and herb stores. Although there were enquiries at that time, a conscious decision was made not to sell in convenience stores. "It was not the right context for the product, said Mr Sommers. Now, the company sells through 4,000 independently owned speciality retailers in the US but includes a ban on sales through vending machines in all its distributor agreements. Natural American Spirit cigarettes will be sold in outlets such as record stores, bookshops, organic food stores and the national specialist drinks retailer, Oddbins. In the UK, specially printed packs contain a toll free number through which smokers can find out more information, including details of their nearest stockist, or even order directly. The only brand available at first in the UK will be the 12 mg version, to accord with EU legislation. [NOTE: Current EU law sets a maximum tar limit of 12mg per cigarette. In May 2001, the European parliament adopted a new directive which set the following new maximums, effective January 1, 2004: 10mg per cigarette tar, 1 mg per cigarette nicotine, and 10mg per cigarette carbon monoxide.] 7
Santa Fe Natural Tobacco is wrong in claiming that it does not use image advertising, criticising the association of a brand name with a cultural ideal and citing the rugged cowboy as an example. In the sense that it does not use conventional media or sponsorship it can fairly make that claim, but media is not the only means of communication and, as tobacco advertising becomes more regulated, the pack will become the main communicator. The Natural American Spirit pack design carries a potent cultural icon, a stylised image of the stereotypical Plains Indian in full feather head-dress smoking a pipe of peace in front of a large red disc, possibly a setting sun There is another reality, as several Native American Indian organisations have pointed out, that, in the past, Indians used tobacco almost exclusively for ceremonial and medicinal purposes. Furthermore, they are very upset about what they see as the exploitation of their sacred symbols and ceremonial practices for the marketing of cigarettes and other products. Consumers certainly seem to notice a distinct difference between Natural American Spirit cigarettes and their mass market counterparts. The cigarettes are strong -- the full strength version weighs in at: a hefty 19 mg of tar and the lights at 12 mg of tar with 1.6 mg of nicotine. It is hardly surprising that some claim to smoke fewer Natural American Spirit than other brands, which has encouraged the company to register the phrase "Smoke less and enjoy it more". Other differences, too, convince smokers that these are no ordinary cigarettes. The taste is distinctive and, as they contain more tobacco, they are harder to draw. There is less side-stream aroma and, when they are left burning in an ashtray, they go out by themselves. And they cost more -- some 15% more than full-price brands. April 1998, The Santa Fe New Mexican: Tully also said many of the issues involved in the tobacco negotiations don't apply to Santa Fe Natural Tobacco Co. "We don 't market to kids, we don't have additives in our cigarettes, we don't adjust the level of nicotine,' he said. "We've never been a member of the Tobacco Institute or colluded with other tobacco manufacturers. And yet we were being drawn into a settlement because of those problems." Santa Fe Natural Tobacco Co. doesn't dispute that there are health risks associated with smoking, Tully said, nor does it disagree with a 1988 report by the U.S. surgeon general that smoking is addictive. 8
March 1998, The Independent (London): The Santa Fe Natural Tobacco Company has just launched Natural American Spirit Cigarettes in Britain, under the slogan "Smoke less and enjoy it more". Natural American Spirit are free of chemical additives such as benzene and saltpetre, tobacco scraps, and artificial flavourings (the manufacturers recommend keeping them in the fridge for added freshness). They already cost pounds 4 per pack, but because they contain more pure tobacco than other brands, smokers are supposed to feel the urge to smoke fewer of them. (Also, the fact that the tobacco is not "puffed" to make it more airy means that actually smoking them is harder work.) Getting hold of them in the shops, however, can be a problem. They are a somewhat exclusive brand, currently available in this country at Harvey Nichols and a handful of other outlets (and via mail order). Johnny Depp, Courtney Love, Sean Penn, Mark Wahlberg, Jude Law, David Lynch, Robin Wright and Liv Tyler have all been spotted with the distinctive sky-blue packet, featuring an Indian chief in silhouette. Critics have accused the microbranders of deliberately targeting younger smokers; but Robin Sommers, founder of the company, points to his policy of not selling in vending machines, supermarkets or convenience-store chains, to make the cigarettes less easy for under-age smokers to buy. "The issue is that people are not going to stop smoking," Sommers has said. "Let's provide the best possible alternative." Sommers himself is a non-smoker; a fact that has been picked up on in some biting editorial. "The Easter Bunny lives! And these cigarettes are healthier!" snorted Newsweek; while Forbes business magazine speculated that American Spirit smokers are "maybe just stupid". [Note: we are searching for the Newsweek and Forbes articles.] January 1998, Santa Fe New Mexican: The New Mexican on Wednesday erroneously reported that Natural American Spirit cigarettes are sold at Wild Oats and Alfalfa's in Santa Fe. John Macker of marketing at Wild Oats said the stores took the cigarettes off the shelves at least a year ago after customers complained about the stores selling any tobacco products. 2980 9
January 1998, Santa Fe New Mexican: The company concedes its cigarettes have higher tar and nicotine levels than leading commercial brands. According to figures supplied by the company and from the Federal Trade Commission, American Spirit's tar levels are 21 milligrams per cigarette, compared to the average of 12 milligrams from a test of 1,249 varieties. The company's nicotine level is 2.2 milligrams per cigarette compared to the average of 0.87. The Surgeon General has determined that tar is carcinogenic and that nicotine causes addiction and may also be carcinogenic. But company officials have said they are unaware of whether nicotine is addictive, according to testimony. The company wrote in a letter to customers that "we want to stress that we do not believe the issue of tar and nicotine is as important an issue in the controversy over smoking as chemical additives. We do believe that the mainstream tobacco companies have focused their promotional efforts on tar and nicotine levels in an attempt to divert public attention away from additives in cigarettes." Company owner Robin Sommers was also quoted with a similar statement in the Organic Times. Campbell defended the statements, saying they are only company's opinions. He cited no factual basis for the statements and said it is the state's burden to disprove them. Bardacke also blasted the company's use of Indian imagery and legends concerning the origins of tobacco in its mail-order literature. One legend from the Cariri Indians of South America said "When the people smoked tobacco, they spoke with god." A company spokesman on Tuesday said the company has ceased using the Indian legends in its advertising. 10
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 ii esto
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, 1990]. 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.¹ 1 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 Respiratory 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 RJRT's 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.³ 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 3 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 ETS 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. 4 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 The 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
The polemical path taken by the Guide relies upon an inadequate review of the available data. Indeed, many statements and implications in the Policy Guide conflict with data reported by the EPA itself, as demonstrated below. 1. ETS Is Not Equivalent To Sidestream Cigarette Smoke Throughout Chapter 1, titled "What is ETS?," the EPA treats ETS as if it were a well- described, stable mixture of SS5 and exhaled MS. The Guide purports to discuss the chemistry of ETS, but includes data only for SS and MS. The authors make no effort to discuss published data regarding ETS chemistry; pertinent studies of ETS in the workplace are ignored [Carson, 1988; Crouse, 1990; Crouse, 1989; Oldaker, 1990a; Oldaker, 1990b; Sterling, T., 1988]. Instead, the authors choose to give the false impression that the properties of ETS are equivalent to sidestream smoke. ETS is neither stable nor equivalent to sidestream smoke. ETS differs significantly both from SS alone and from a simple combination of SS and exhaled MS. ETS is "an aged, dilute mixture of sidestream and exhaled mainstream smoke from combustion of tobacco products such as cigarettes, cigars, etc." [Ogden, 1988, p. 77]. The Guide ignores this distinction. One scientist who has studied cigarette combustion processes and cigarette smoke generation for more than two decades stated, "Several scientists have incorrectly assumed that concentrated, fresh SS is the same as ETS and have 5 Sidestream smoke is that smoke emitted by a cigarette between puffs plus a small amount of smoke escaping during the puff. 6 Exhaled MS is not the same as MS generated by smoking machines for analysis. In addition to the aging effects, some of the smoke inhaled is retained by the smoker. 8
consequently made invalid conclusions concerning the properties of ETS" [Baker, 1989, p. 2]. EPA scientists have themselves concluded that "ETS differs both chemically and physically from the precursor sidestream smoke, presumably due to chemical and physical transformations that occur as the mixture is diluted and aged" [Lofroth, 1989, p. 610]. The Guide does not acknowledge the existence of literature that describes the unique physical and chemical properties of ETS [Baker, 1990; Baker, 1989; Eudy, 1986; Harke, 1974; Hulka, 1988; Ingebrethsen, 1989; Proctor, 1988; Reasor, 1987; USPHS, 1986]. The Guide's discussion of ETS composition [The Guide, pp. 7-10] disregards dissipative forces, e.g., air currents, ventilation, diffusion, surface sorption, that greatly dilute sidestream and exhaled mainstream smoke. Some studies [Mahajan, 1990; Oldaker, 1989] indicate that ETS is diluted 100- to 1000-fold, compared to SS. Actual ETS constituent concentrations often fall below detection limits of current scientific detection techniques [Carson, 1988; Crouse, 1989; Oldaker, 1990a; Oldaker, 1990b; Oldaker, 1986]. Consequently, characterization of ETS by relying solely on SS and MS data is fallacious. ETS is a dynamic mixture of aged and diluted SS and exhaled MS. "[O]nce the smoke has left the cigarette, cigar or pipe, its physical nature and relative chemical composition will change dramatically" [Proctor, 1988, p. 58]. During aging, chemical reactions and physical processes change the chemical composition as well as the distribution of compounds between gaseous and particulate phases. A variety of studies have shown that nicotine in ETS is almost entirely in the vapour phase. This contrasts sharply to fresh mainstream smoke where nicotine is almost entirely in the particulate phase, and to exhaled mainstream smoke where there is actually little nicotine left. In fresh sidestream smoke, about 80% of the nicotine is in the vapour phase. Thus, as 9
sidestream smoke is diluted and ages to form ETS, nicotine evaporates out of the particles. Other quite different studies have shown that matter evaporates from sidestream particles as they age to ETS. Ingebrethsen has estimated that 20-30% of the original matter in sidestream smoke particles is lost in this way. This is accompanied by a shrinkage of the particles. In addition to physical changes, chemical changes also occur as ETS ages. Thus, for example, nitric oxide slowly oxidizes over minutes and hours to nitrogen dioxide in ETS. However, these chemical changes, and indeed the particle size changes described above, will be far outweighed by the physical effects of air movement which occur in real indoor environments [Baker, 1989, p. 5]. Chapter 1 of the Guide contains a table, "Toxic and Cancer-Causing Agents in Mainstream and Sidestream Cigarette Smoke" [The Guide, p. 10], that is not worthy of publication. It reports only sidestream and mainstream data and ignores available and more pertinent data on ETS constituents in real-world environments. The table is inaccurately labelled and not all compounds listed have been reported to be "Toxic and Cancer-Causing Agents." Units in the table are incorrect in some cases and missing in one instance. Finally, cigarette types are unidentified and analytical procedures are unspecified. As a result, it is impossible to judge the accuracy of the concentrations reported. Like the table, the authors ignore fundamental principles pertaining to the physical and chemical properties of ETS. The Guide does not include any original data on the composition of ETS, although there are peer-reviewed reports in the literature. Contrary to the authors' misstatements and mischaracterizations: 1. ETS is a complex, constantly evolving mixture of SS and exhaled MS. Implied equivalence with SS is false and deceptive. 2. ETS is hundreds to thousands of times more dilute than either SS or MS. 10
Further, the Guide's insinuation that nonsmokers are exposed via ETS to higher concentrations of smoke constituents than smokers via MS is patently ridiculous. There is no authority for such a proposition. 2. Constituents Of ETS Provide No Basis To Reach Conclusions Regarding ETS And Health In discussing the alleged "Hazardous Constituents in ETS," the Guide states that "[m]any of the chemicals in ETS are known carcinogens, mutagens, toxins or irritants" [The Guide, p. 8]. The Guide then suggests that ETS is more hazardous than MS by stating that "sidestream smoke is known to have significantly higher concentrations of carcinogens and mutagens than mainstream smoke" [The Guide, p. 9]. Finally, the Guide relies on individual constituent studies to support its assertions about the alleged biological properties of ETS. These points are based on the false premise that the physicochemical properties of ETS are equivalent to those of SS, MS or a combination of the two. The Guide makes no effort to discuss the chemical composition of ETS, except in the inappropriate context of SS and MS. As described above, ETS is not identical to SS or to a simple combination of SS and MS. Because of dilution and dissipative forces, ETS is much more dilute [Mahajan, 1990; Oldaker, 1989]. The concentration of ETS and its constituents in the workplace environment is the true issue. The Guide's failure to take into account and describe facts about ETS constituent concentrations deceives the reader. The Guide fails to place the magnitude of real-world ETS exposures in a meaningful context. Paracelsus pointed out a fundamental axiom of toxicology 500 years ago: "All substances are poison; there is none which is not a poison. The right dose differentiates a poison and a remedy" [Klaassen, 1986, p. 1]. Recently Ames paraphrased the principle in 11
a more specific context: "Thus, a high percentage of all chemicals might be expected to be carcinogenic at chronic, near-toxic doses and this is exactly what is found" [Ames, 1990, p. 970]. Therefore, any discussion of "hazardous constituents" that does not consider dose (hence, concentration) is meaningless from a toxicological perspective. The EPA's presumption that, in the absence of evidence for a threshold, any exposure to a cancer-causing agent increases the risk of cancer, does not change this toxicologic principle. Virtually every food (e.g., cooked meats, black pepper, coffee, mustard, celery, parsley, basil, oranges) and material (e.g., air, water, sunlight, our own bodies) known to man contains substances that are carcinogenic, mutagenic, or toxic. Ames has noted that the foods in every meal contain many mutagens and carcinogens: The cooking of food produces thousands of pyrolysis products, and we estimate that dietary intake of these products is roughly 2000 mg per person per day. Few of these have been tested; for example, of 826 volatile chemicals that have been identified in roasted coffee, only 21 have been tested chronically, and 16 are rodent carcinogens; caffeic acid, a non-volatile carcinogen, is also present. A cup of coffee contains at least 10 mg (40 ppm) of rodent carcinogens (mostly caffeic acid, catechol, furfural, hydrogen peroxide, and hydroquinone). Thus, very low exposures to pesticide residues or other synthetic chemicals should be compared to the enormous background of natural substances [Ames, 1990, p. 971]. In fact, no substance has unequivocally been shown to be free of carcinogenic or mutagenic properties.7 The Guide makes no effort to report the concentrations at which any of the "hazardous constituents" are present, if detectable at all, in ETS. 7 For example, the only substance that has been certified by the International Agency for Research on Cancer ("IARC") as being non-carcinogenic to man, caprolactam, is mutagenic in several widely used test systems [Ashby, 1985]. 12