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Comments on: ENVIRONMENTAL TOBACCO SMOKE. A GUIDE TO WORKPLACE SMOKING POLICIES [Draft] EPA/400/6-90/004 Response Addressing: Chapter 2: Measuring ETS in the Air and Body Section: Assessing ETS Exposure Section: Air Monitoring Studies Prepared by: Guy B. Oldaker III, Ph.D. Senior Staff R&D Chemist and Michael W. Ogden, Ph.D. Senior R&D Chemist R.J. Reynolds Tobacco Company October 1990

SUMMARY Chapter 2: Measuring ETS in the Air and Body, ASSESSING ETS EXPOSURE, Air Monitoring Studies provides a distorted, incomplete, and naive view of the stated subject. This section of the Guide, in its present form, guarantees that users will make uninformed and subjective decisions regarding smoking policies. The inaccuracies, limited number of supporting literature, and imprecise word usage indicate either egregiously poor scholarship or a deliberate attempt to misinform. The EPA has failed entirely in the section on Air Monitoring Studies to provide a single, representative example of average RSP concentrations in workplaces where smoking is permitted. By using the National Ambient Air Quality Standard (NAAQS) for particulate matter as a point of reference for indoor levels of ETS, the EPA. (a) misinforms the public regarding the intent of the NAAQS and their regulation, and (b) disregards the regulatory process which they are legally required to observe. Specific comments are provided below. ITEM 1. After discussing briefly four ways to assess ETS exposure (namely, monitoring the air, measuring biological markers, administering questionnaires, and applying mathematical models), the Guide states at p. 12: Since -1981, approximately 50 studies have been done of ETS concentrations in buildings. Using these methods, researchers have found that [a] ETS diffuses rapidly through buildings, [b] persists for long periods after smoking ends, and [c] represents one of the major sources of indoor particulate pollution. 2

COMMENTS 1. Incomplete review The paragraph lacks completeness. Air monitoring studies were done before 1981. Indeed, a sufficiently large number of studies existed in 1982 to justify review by Sterling et aL [1]. This reviewer recommends that the EPA perform a more thorough review of the literature relating to "air monitoring" for ETS. This reviewer also questions whether 1981 holds any special significance. If this year is important, the EPA should explain why. 2. Absence of adequate literature citations The Guide needs literature citations for the "approximately 50 studies" that have been done. This sentence suggests that a fairly large body of information exists on the assessment of exposure to and the physical behavior of ETS. In addition, the sentence suggests that this information presents a consistent picture of the three findings the paragraph summarizes. To this reviewer's knowledge, the literature does not provide a picture consistent with these findings nor does it generally support these findings. 3. Failure to follow logical process The EPA also implicitly fails to follow the logical process required to support this paragraph in particular and the contents of the Guide in general. Thus, in attempting to interpret the significance of the reference to 50 studies, this reviewer must question the EPA's technical basis for the Guide. The EPA is an agency bound by scientific and technical principles including observance of the logical framework that the stated findings imply. The logical development of this Guide requires that the EPA first complete the technical and scientific analyses of the issue to support policy. The Technical Compendium drafted earlier by the EPA theoretically could have provided this support. However, because of many technical deficiencies, the draft Compendium fails to achieve this end. Consequently, this reviewer concludes that the EPA has failed to 3

provide the public with the support for the policy pronounced by the Guide. In simple terms, the absence of adequate support for the Guide shows that the EPA is either putting the cart before the horse or intends to omit the horse altogether. Clearlv, it is essential that the EPA prepare a scientifically sound, peer-reviewed technical document to support the Guide. 4. Implications regarding what the studies measured The first sentence is misleading because it suggests that the "50 studies" measured "ETS concentrations." Because no ideal indicator (or marker or surrogate) for ETS exists, it is incorrect to say that ETS concentrations are measured. Furthermore, because ETS comprises two phases (a particulate phase and a gas phase), estimating "ETS concentrations" at a minimum requires measuring two indicators: One for the vapor phase, the other for the particulate phase. Most studies reported in the literature measured a single surrogate of ETS exposure, therefore restricting exposure assessment to only one ETS phase. Few studies (substantially less than 50) have included more than one surrogate that, in principle, could allow estimates of exposure to both phases. 5. Implications on the quality of the studies Without literature citations for the "50 studies," this reviewer, and for that matter, the potential users of this Guide, are left to assume that the quality of each of the 50 studies is adequate to support their collective mention. This assumption is highly questionable, and probably false. The literature on ETS measurements shows that studies vary widely in terms of quality. Indeed, the literature documents discredited studies; e.g., Green et al [2_] discredited the work reported by Williams et al. which the Guide itself cites. (See p.70: 73. WILLIAMS, DC., WHITTAKER, JR., JENNINGS, WG. Measurement of nicotine in building air as an indicator of environmental tobacco smoke levels, Environmental Health Perspectives, Volume 60, p. 405-410, 1985.) Inasmuch as one such discredited study is cited in the Guide to support the EPA's position, this 4

reviewer must question the quality of the "50 studies" which the EPA uses to support the three findings. r 6. Implied meaning of the word "study" Used in conjunction with the word "study," the phrase "using these methods" is vague and therefore misleading because it implies that the "50 studies" mentioned earlier include those where mathematical models, biological monitoring, and questionnaires were employed. Mathematical modeling of ETS exposure has not been validated. An error analysis derived from information presented by the National Research Council [4] demonstrates that some models reported in the literature cannot provide reliable predictions of ETS exposure (see review by Drs. Sears and Cole included in the Company's response). In addition, this reviewer is unaware of any study where questionnaires were employed that pertained to any of the three findings (identified as a, b, and c under Item_1.) Indeed, this reviewer fails to see how questionnaires could be employed scientifically to address any of the three findings. 7. Implied pertinence of buildings studied Without citations for the "50 studies," the user of the Guide is has to assume that the buildings studied are pertinent to the needs and interests of "government and private sector decision makers," the intended users of the Guide. This probably would be an incorrect assumption. Given that the Guide relies heavily on citations relating to studies of private residences (see the paragraphs below in the section titled Air Monitoring Studies), this reviewer questions the general pertinence of the "50 studies" mentioned. Clearly, the Guide would serve the needs of its intended users better by discussing studies carried out in workplaces. 5

ITEM 2. The Guide states on p. 12 under Air Monitoring Studies: "However, studies show that where smoking is permitted, ETS is the major contributor to RSP in indoor air.27" COMMENTS 1. General This statement is false. Additionally, semantic carelessness leads to the reasonable conclusion that the intent of the sentence is to misinform. 2. Inappropriateness of the word "studies" The word "studies" does not agree in number with the literature citation, which describes a singular study. Clearly, this sentence, which makes a very strong point, demands a commensurately strong citation of the supporting literature. 3. ETS not "the major contributor" The results presented and cited (SPENGLER, JD., DOCKERY, DW., TURNER, WA., WOLFSON, JM., FERRIS, BG, Jr. Long-term measurements of respirable sulfates and particles inside and outside homes. Atmospheric Environment 15(1): 23-30, 1981) [5] do not support the finding that "ETS is the major contributor to RSP in indoor air." For example, Table 2 in that publication shows a mean indoor RSP concentration of 24.4 µg/m' for 35 homes with no smokers. The mean concentration shown for 15 homes with one smoker is 36.5 µg/mj. If one assumes that RSP from ETS accounts for the difference between the two results, then ETS contributes 12.1 µg/m3 to the total RSP, 36.5µg/m3, in the homes with one smoker. This contribution represents 33.2% of the total. "The major contributor?" No, hardly. This reviewer recommends that the authors revise this sentence to be accurate. 6

4. Insuflicient data to support policy This reviewer concludes that the study by Spengler et aL [1] contains insufficient data to support generalization about the contribution of ETS to RSP levels in homes. Thus, the study reports results from measurements of 55 homes located in six cities. Of these, 35 were identified with no smokers, 15, with one smoker, and 5, with "2+" smokers. 5. Pertinence of homes to users As mentioned above (ITEM 1., COMMENT 7.), measurements of ETS exposures in homes is not pertinent to those places, e.g., workplaces, which would affect the users of the Guide. 6. Inappropriate use of the word "permitted" In the sentence, use of the word "permitted" is inaccurate, inappropriate, and misleading. This reviewer is led to question the authors' motives. Users of the Guide could interpret this sentence to mean that studies were conducted in public places because permission to smoke would be an issue there. Few users would review the footnotes to learn the title of the paper cited; fewer still would read the paper itself. Why is it then that the authors used the phrase 'where smoking is permitted" rather than, for example, the phrase "in homes where smoking occurred"? ITEM 3. The Guide states in several places that: ETS diffuses rapidly through buildings. [See p3, Measuring ETS in the Air and Body; p. 12 under ASSESSING ETS EXPOSURE; and p.22 under CHAPTER 5: Reducing Exposures to ETS.] 7

COMMENTS 1. Misuse of the term diffusion This reviewer assumes that the EPA means dispersion rather than diffusion. Diffusion relates to motion associated with molecular properties of matter. Diffusion of RSP is therefore necessarily slow. The EPA should use the term "dispersion" to be technically accurate. 2. Failure to address the effects of dilution Assuming a value for "rapid," one can argue the truth of this statement based upon fundamental principles of physical chemistry. However, such an argument would address only part of the truth. Through omission, the statement misrepresents the science relating to ETS exposure and is therefore misleading. Put simply, rapid dispersion must be accompanied by great and equally rapid dilution. Experimental support for the relation between dispersion and dilution comes from a comparison of measurements of ETS indicators in smoke plumes with measurements of the same indicators in field settings. Although experiments verify the relation between dispersion and dilution, experimental support for the rapid dispersion of ETS through buildings is meager and ambiguous with respect to implications for ETS exposure. The literature contains very few studies where air monitoring was employed to investigate the matter of the rapid ETS dispersion in buildings. Reported studies involving mathematical modeling assume a priori the untested postulate that dispersion is rapid, and are therefore logically inappropriate for addressing the issue. The fundamental problem, however, is that none of the air monitoring studies reported in the literature employed indicators of ET'S exposure that were capable of providing unambiguous results regarding dispersion of ETS. Studies that monitor either RSP or CO as indicators are incapable of adequately accounting for non ETS sources. Studies that monitor the air for nicotine or that measure biological markers (and only cotinine, a nicotine metabolite, is viable) indicate nicotine vapor exposure only and not exposure 8

to the particulate phase of ETS. For example, Nelson et aL [¢] have shown from field studies the presence of residual nicotine in the absence of ETS RSP. The matter of dilution raises a related question: What is the de minimis level of an indicated ETS exposure? Is it the EPA's policy that any measurable amount of an ETS indicator is evidence of biologically significant exposure? These are both critical questions. With enough effort, scientists can find those stray molecules of ETS indicators that originate, for example, from the clothes and bodies of smokers who occupy environments, yet do not smoke there. What would the EPA's position be if, for example, nicotine was detected in the ambient air in a park or on a street corner? ITEM 4. The Guide states in several places: [ETS] persists for long periods after smoking ends. (For example, see p. 3 under Key Points and p. 12 under ASSESSING ETS EXPOSURE.) COMMENT 1. Failure to address dilution The issue of persistence is closely linked to the issue of the rapid "diffusion" of ETS commented upon above. Major questions in this regard include: 9

(a) How long does ETS persist in buildings? The EPA is obligated to provide some quantification of this point. (b) What literature supports this finding and why does the Guide not cite such necessary supporting literature? Again, it is incumbent upon the EPA to provide supporting literature. ITEM S. The Guide states at p.12 under Air Monitoring Studies: However, neither type of monitor measures all the components of ETS because the number of constituents is too large. COMMENT 1. Failure to adequately identify limiting factors This statement is incomplete and inaccurate because it implies that monitoring is limited only by the large number of ETS constituents. The more important limiting factors include: (a) the unavailability of sufficiently validated methods for determining constituents in ETS collected from representative situations; (b) sampling constraints, for example, detection of most constituents requires sampling exceedingly large volumes of air, which is impractical; and (c) most ETS constituent concentrations (which are postulated to ezist based upon their identification in mainstream and sidestream smoke) are below the limits of detection for those relatively few cases where methods are available. To be complete the EPA must address these factors. 10