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Whose standard is it, anyway?
  1. RICHARD R BAKER
  1. Research & Development Centre
  2. British American Tobacco
  3. Southampton SO15 8TL, UK
    1. FRANÇOIS JACOB, Secretary General, CORESTA
    1. 11 rue du Quatre Septembre
    2. 75002 Paris
    3. France
    4. coresta.foj{at}wanadoo.fr
      1. STELLA AGUINAGA BIALOUS,
      2. DEREK YACH
      1. Tobacco Free Initiative
      2. World Health Organization
      3. Geneva, Switzerland
      4. stella{at}bialous.com

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        Editor—In their recent article inTobacco Control Bialous and Yach1create the impression that international standards for the machine smoking of cigarettes were foisted on the smoking public unilaterally by the tobacco industry by its influence on the International Organization for Standardization (ISO) through control of CORESTA (Centre de Co-operation pour les Recherches Scientifiques au Tabac). They also allege, inter alia, that the tobacco industry (1) has, through CORESTA, changed the methodology in order to produce lower smoke yield values to get round the European “tar” ceiling directives, and (2) misleads the public by developing low “tar” cigarettes to cheat the smoking machine, and then makes unjustified health claims about them. (“Standards” are documented agreements containing technical specifications or concise criteria to be used consistently as rules guidelines.)

        In their article, Bialous and Yach1 concentrated predominantly on a few highly selective quotes from internal tobacco company documents. They appear not to have consulted much of the very large volume of scientific literature published on the subject. When this information is taken into account it becomes obvious that the very narrow and restricted literature base of Bialous and Yach's analysis has resulted in them making factual errors, drawing wrong conclusions and writing inaccurate statements on many aspects of the subject.

        A review of the published literature on the subject shows clearly that the broad facts are as follows:

        (1) Techniques relevant to the machine smoking of cigarettes were developed and refined throughout the 20th century.2 3 The first standard was specified by the Federal Trade Commission (FTC), a US federal government agency, in 1966 and first used to test cigarettes in 1967.4 The CORESTA recommended method, similar in many respects to that of the FTC, was developedafter the FTC standard and was published in 1969.5

        (2) There were small differences in the details of the smoking machine procedures in the various standard methods developed by the FTC and subsequently CORESTA, ISO and authorities in the UK, Germany, Canada and elsewhere between 1969 and the late 1970s.6 These differences resulted in about a 10% difference in the “tar” yield of the same cigarette measured by authorities in Britain and Germany,7 for example. By the late 1980s it was recognised that this situation was unacceptable in view of pending European directives which specified “tar” ceilings for all cigarettes sold in member states across Europe from 1993. Consequently, the differences in methodology were harmonised in a common ISO standard method in 1991, developed following a considerable amount of inter laboratory comparisons of the developing methodology undertaken within CORESTA across 29 laboratories from 15 countries.7 This revised standard method is now used in all countries except the USA where the slightly different FTC method still continues to be used, and in Japan where some minor differences are used in their national standard. Changing to the ISO standard in the early 1990s, “tar” yields determined in the UK, for example, decreasedby up to 0.5 mg while “tar” yields in Canada, for example,increased by up to 3 mg for some brands.

        (3) The purpose of the smoking machine standards is to determine the “tar”, nicotine, and carbon monoxide content of cigarette smoke when the cigarette is smoked under precisely defined conditions, and hence to allow a comparison of the yields from different cigarettes. Such yields are not predictive of the yields humans obtain when smoking, nor were they ever expected to be so, since no two smokers smoke exactly the same nor does a smoker smoke a cigarette the same way on every occasion. This purpose has been stated consistently many times, originally by the FTC in 1967,4 and subsequently in the scientific literature, published by the tobacco industry and health/regulatory authorities, over the last 35 years, e.g.8 9

        (4) Compensation by smokers when switching to a low “tar” cigarette has been discussed in the scientific literature for 40 years. The phenomenon was first published by the tobacco industry and tobacco industry scientists have published books and papers on the subject, e.g.10 11 The available evidence, albeit limited, indicates that compensation is partial in the short term (up to a few weeks), and that smokers switching from a higher to a lower “tar” yield cigarette do generally obtain a reduction in smoke delivery.11

        (5) Since the 1950s numerous health scientists have advocated that lower “tar” cigarettes should be developed on the grounds that they may represent a less hazardous form of smoking, e.g.2 12-15 Health authorities have consistently advised smokers to quit, but for those who choose to continue to smoke that they should smoke lower “tar” cigarettes, e.g.8 16 17 The tobacco industry has responded to these health authorities by developing cigarettes with lower “tar” but has also followed public health advice by not advertising lower “tar” cigarettes as safe cigarettes.

        References

        Editor—In a recent article, Bialous and Yach1-1 attempt “to describe the extent of the tobacco industry involvement in establishing international standards for tobacco and tobacco products.” They assert that “it is clear that the tobacco industry, through [CORESTA], play a major role in determining the scientific evidence and suggesting the standards that are eventually developed as international standards.” Finally, they conclude that “ISO's tobacco and tobacco products standards are not adequate to guide tobacco products regulatory policies, and no health claims can be made based on [these] standards.” Moreover, along the way, these authors seem to suggest some impropriety in CORESTA's involvement in the standards setting process and offer some examples that, they believe, support a contention that is in fact untrue.

        CORESTA (Cooperation Centre for Scientific Research Relative to Tobacco) is an organisation devoted entirely to issues related to tobacco science. Those issues range from plant breeding and good agricultural practices to technological aspects of manufacturing and analytical determination of smoke yields. That the majority of worldwide tobacco science expertise resides within the tobacco industry should come as surprise to no one (as would be true for most industries facing technical challenges). That many of these same experts find themselves involved in CORESTA and International Organization for Standardization (ISO) TC-126 activities should, likewise, be of no surprise. Development of technical standards, whether within CORESTA or ISO or elsewhere, without relying on the best available technical expertise would, of course, be irrational.

        Regarding the suggestion of impropriety, Bialous and Yach outline three areas they believe support their case. First, they claim “[ISO] standards are approved as recommended by CORESTA, with limited opportunity for significant amendments”. Offered as an example is an excerpt of CORESTA minutes regarding ISO/DIS 11454, stating that the DIS (Draft International Standard) will be published as an international standard with no changes other than editorial. What Bialous and Yach apparently fail to appreciate is that the ISO approval process leading up to the DIS stage involved a development period of at least four years and multiple balloting stages (opportunities) for significant amendments. For example, balloting at the previous committee draft stage (ISO/TC 126 N 537, July 1995) generated nine pages of comments from 12 countries. The 1997 CORESTA minutes reflect only that at the DIS stage in the overall ISO process, no changes had been requested by ISO members other than those of an editorial nature.

        Secondly, Bialous and Yach made a compound assertion, that “CORESTA works with ISO directly or that CORESTA works through one of ISO's member bodies”. CORESTA does have a liaison member status with ISO, but does not work with any of ISO's member bodies.

        Lastly, Bialous and Yach assert “CORESTA resists any interference with its proposed standards, and make efforts to keep overall control of the situation and the outcomes of ISO meetings”. Offered as support is a matter concerning updates to the ISO smoking methods. Again, an egregious misinterpretation has resulted. A CORESTA working group and the British Standards Institution (BSI) independently prepared editorial commentary on similar issues within the text of the ISO smoking methods. Wishing to defer to the ISO process, CORESTA postponed an update to the existing CORESTA methods, instead wishing to wait for ISO to finish their deliberations.

        On these claims of impropriety, Bialous and Yach offer examples that do not support their contention. Rather to the contrary, these examples serve as testament to the propriety of the CORESTA-ISO relationship.

        We look forward to a continued relationship with all parties with an interest in the business of technical standardisation related to tobacco and tobacco products.

        References

        1. 1-1.

        Author's reply

        Editor—Mr Jacob and Dr Baker's criticisms of our paper2-1 mostly indicate an incomplete reading of it. We believe our paper reached its stated objective and showed that “the tobacco industry, through [CORESTA], play a major role in determining the scientific evidence and suggesting the [international] standards.” Our conclusion that “ISO's tobacco and tobacco products standards are not adequate to guide tobacco products regulatory policies, and no health claims can be made based on [these] standards” derives both from the evidence in the paper and evidence from studies and international reviews.2-2 2-3 Such standards are useful to rank cigarettes' nicotine and tar yields according to machine measurements, they do not reflect human smoking, and measurement methods can be modified to provide different readings without the need for product modification, a point also made by Dr Baker.

        Recent literature and health authorities' recommendations regarding “lower” tar and nicotine cigarettes show that switching to lower yields is no longer perceived as an effective public health measure to address tobacco related morbidity and mortality.2-3-2-5Several countries and the European Union have already banned or are moving to ban the utilisation of labels such as “mild” and “lights” based on scientific and tobacco industry document evidence that these mislead the public into thinking these cigarettes are safer.2-6-2-10

        Indeed, a 1977 British America Tobacco (BAT) document stated: “All work in this area should be directed towards providing consumer reassurance about cigarettes and the smoking habit. This can be provided in different ways, for example, by claiming low deliveries, by the perception of low deliveries, and by the perception of “mildness”. Furthermore, advertising for low delivery or traditional brands should be constructed in ways so as not to provoke anxiety about health, but to alleviate it, and enable the smoker to feel assured about the habit and confident in maintaining it over time.”2-11

        We do not suggest “impropriety in CORESTA's involvement” since, as per the ISO definition, the tobacco industry is entitled to participate in the process. However, we question the adequacy of having tobacco interests being the sole provider of scientific evidence in the area of tobacco products standardisation methods. We question CORESTA's involvement as much as the lack of involvement from other interested parties (for example, health and consumer groups) as well as whether or not the ISO is fulfilling its aim of protecting the health and safety of consumers of tobacco products.

        Mr Jacob's assertion that the “majority of worldwide tobacco science expertise resides within the tobacco industry should come as surprise to no one” is correct. However, recent litigation has shown that this expertise has not been used to benefit the health and safety of the consumers of tobacco products.2-12-2-14 It is also no surprise that many of the tobacco industry experts “find themselves involved in CORESTA and ISO TC-126 activities”, but it is unacceptable that these experts be the only ones participating in these activities.

        As for the three specific areas of criticism in Mr Jacob's letter:

        (1) From the description of the ISO standards approval process,2-15 the majority of work is done at the Technical Committee (TC) level, and final approval of a DIS (Draft International Standard) is by the TC as well. In the case of TC 126, with a majority of members representing the tobacco industry, and CORESTA being the organisation conducting the work on the proposed standards, amendments are referred back to the TC and to CORESTA. In the example offered, ISO/DIS 11454, reference 34 in our paper2-16 describes some of these comments and how they represent the tobacco industry's perspective.

        (2) The assertion “CORESTA works with ISO either directly or through one of ISO's members bodies . . .” emphasises the great overlap among the people (and interests) who are members of CORESTA, TC 126 and those involved in tobacco issues at member bodies such as British Standards Institution (BSI) and American Natioal Standards Institution (ANSI). Although no official relation between CORESTA and ISO's member bodies exists, it is clear that efforts are often agreed upon. In the example provided, at a CORESTA Scientific Commission meeting2-17 a method for environmental tobacco smoke (ETS) determination was sent to ISO via ANSI. (An unquoted example, from reference 45,2-18 states that CORESTA had prepared a draft standard on ambient air to be circulated at BSI.)

        (3) We saw no evidence that CORESTA accepts outsiders' input in preparing standards forwarded to ISO, but it is clear that it wants to maintain “CORESTA methods and ISO standards . . . close or identical.”2-19 The following quote from the same document2-19 addresses how CORESTA planned to deal outside participation (by participation in the validation stage, not in the development, of a measurement method).

        We appreciate the opportunity to address these comments, and Mr Jacob's offer for a continued dialogue in the area of standardisation of tobacco products.

        References

        1. 2-1.
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        17. 2-17.
        18. 2-18.
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