1. Strategies for regulation of cigarette emissions The WHO product regulatory approach Nigel Gray David Burns For TobReg Working Group 1 in Conjunction with IARC

2. Executive Summary The WHO Framework Convention on Tobacco Control (WHO FCTC) recognizes the need for tobacco product regulation in Articles 9 & 10. Existing product regulatory strategies based on the machine measured tar, nicotine and carbon monoxide (CO) yields per cigarette with the current ISO regimen are causing harm. By allowing communication of the yields as measures of exposure or risk, they mislead smokers into believing that low yield cigarettes have less risk and are a reasonable alternative to cessation. This ongoing harm precludes continued acceptance of strategies of product regulation utilizing per cigarette machine measured tar and nicotine values and necessitated the development of a new approach. A TobReg/IARC working group was formed to consider an alternative approach.

3. Executive Summary TobReg recommends a strategy for regulation based on product performance measures with the goal of reducing toxicant levels in mainstream cigarette smoke. It recommends establishing levels for selected mainstream smoke toxicants per mg nicotine and prohibiting the sale or import of cigarette brands that have yields above these levels. The purpose of normalizing toxicant levels per mg nicotine is to shift the interpretation of the measurement away from the quantity of the smoke generated per cigarette, and away from the misleading use of TNCO values as measures of human exposure and risk. It moves towards product characterization of smoke toxicity generated under standardized conditions.

4. Caution on Communication Prohibiting consumer communications based on any machine measurements will also be necessary. This will minimize the likelihood that consumers will be misled into thinking that the machine measured yields represent exposure of the smoker, as has been occurring with existing ISO tar, nicotine and CO (TNCO) values.

5. Why Use Machine Measurements The ideal product regulatory strategy would include measures of human exposure and injury. Validated biomarkers of harm do not currently exist. Validated biomarkers of exposure do exist, but their use for product regulation is problematic. Given these constraints, the current regulatory strategies are limited to product performance standards based on product ingredients and emissions using machine generated smoke.

6. Selection of Toxicants The list of toxicants selected was based on an assessment that included consideration of: – animal and human toxicity data, – toxicity indices, – variability of the toxicants across brands, – the potential for the toxicant to be lowered, – inclusion of constituents from both particulate and gas phases of smoke and from different chemical classes in cigarette smoke. Consideration was also given to selecting compounds implicated in cardiovascular and pulmonary toxicity as well as carcinogenicity. The most important criterion for selecting compounds for regulation was the toxicity evidence.

7. Initial Levels Available data on the variation in the toxicant levels for cigarette brands provide an initial set of observations used to identify levels of reduction that have already been achieved by some products on the existing market. The levels recommended represent TobReg’s judgement from available data as to the most practical trade-off considering the need to regulate a range of toxicants, to mandate substantive lowering of those toxicants, and yet not to recommend elimination of most of the brands. Regulators are encouraged to obtain data from their own markets and select different levels more appropriate for their own circumstances.

8. Table 1. Toxicants recommended for mandated lowering

9. Use of the Levels The levels in Table 1 for the column labeled “international brands” are based on data reported from an international sample of U.S. Style cigarette brands using a blend of tobaccos. The column labeled “Canadian brands” is based on a set of brands reported to Health Canada which reflects cigarettes using predominantly flue-cured (bright) tobacco. Regulators should use data reported for their own markets (if available) to set levels or they may select the values derived from the data set that conforms most closely to the cigarettes available on the markets being regulated.

10. Effect on the Market Proportion of Brands Remaining After Constituents Removed By Percentile in Order of Their Cancer Index International Brands, Canadian Intense

11. Phasing of the Regulatory Strategy The regulatory strategy should be implemented in phases: – A period of required annual reporting of a larger (44 toxicants) list toxicant levels by cigarette manufacturers to the regulatory authority. – Promulgation of the levels for selected toxicants above which brands cannot be offered for sale. – Enforcement of the established levels. Regulators will take additional actions to further reduce the mandated levels of toxicants in the form of setting targets or milestones based on what may be achievable with new technology or product designs.

12. Regulatory Strategy Focuses on the product and the smoke generated under standardized conditions. Will make regulation of cigarettes consistent with other regulatory approaches which mandate reduction of known toxicants in products used by humans. The anticipated outcome is a marketplace that excludes those brands with the highest levels of toxicants. This strategy neither uses nor relies on measures of actual or estimated human exposure or risk, and so cannot be used to quantify reductions of human exposure, risk or disease. It does rely on and use measures of clearly established toxicants as they appear in tobacco smoke generated under standardized conditions.

13. Goals for Setting Levels The goal of the proposed regulatory strategy is to reduce the levels of toxic constituents measured under standardized conditions in the smoke of cigarettes allowed on the market. A secondary goal is to prevent the introduction into a market of cigarettes with higher levels of smoke toxicants than are present in brands already on the market.

14. Uses Other Than Mandated Lowering

15. BENZOAPYRENE yield per Mg Nicotine In Canadian Brands

16. NNN and NNK by Brand for Canadian Cigarettes

17. Mean and range of NNN and NNK yields per mg nicotine for brands reported to the Australian government in 1999 contrasted with the levels of NNN and NNK reported for a Philip Morris Marlboro brand identified as being an Australian brand.

18. Other Issues Considerations for modified cigarettes and potential reduced exposure products Monitoring for unanticipated increases in yields of other toxicants Extension to Smokeless tobacco products

20. Selection of Machine Method Toxicant yields vary with different machine methods even when standardized per mg nicotine or per mg tar Ranking of brands by toxicant yields per mg nicotine is not constant with the different machine methods

21. Canadian Method Selected Results in less variation in replicate measurements of the same brands More intense smoking parameters than ISO Better characterization of some design features such as charcoal filters No method perfect, ideal is to test more than one method

22. Mean of the coefficients of variation of replicate measurement for four nitrosamines plotted by the tar level for individual brands measured by each of three machine testing protocols

23. Selection of Toxicants Only Health Canada Constituents available for evaluation The list was prioritized by: – the known animal and human toxicity data for the compounds, – toxicity indices based on the concentration of the constituent times its toxic potency, – the variability of the toxicant across brands, – the potential for the toxicant to be lowered in cigarette smoke with existing methods, – the need to have constituents that represent the different phases of smoke (gas and particulate), different chemical families and toxicities that reflect heart and lung disease as well as cancer. The most important criteria for selecting compounds for regulation are the toxicity evidence.

24. Ranking of Toxicants in Smoke with Respect to Toxicant Animal Carcinogenicity Indices

25. Ranking of Toxicants in Smoke with Respect to Toxicant Non-Cancer Response Indices

26. Toxicants to be Reported

28. Procedure/process of implementing mandatory reductions in toxicant yields The regulatory strategy should be phased, with a period of required reporting of toxicant levels by cigarette manufacturers, followed by an announcement of the maximal levels for toxicants, and finally enforcement of those mandated limits. For countries without cigarette manufacturing facilities or with limited laboratory capacity, the values presented in Tables 1 and 9 represent reasonable initial regulatory levels. The initial reporting of toxicants should include all of those currently reported to Health Canada. Following the initial reporting, a more limited list of toxicants presented in Table 6 are recommended for annual reporting, with the more complete list reported every five years.

29. Procedure/process of implementing mandatory reductions in toxicant yields After a reporting period of 2-3 years, initial mandated limits for toxicants other than NNN and NNK would be set using the level of the toxicant per mg nicotine representing 125% of the median value for the toxicant for the reported brands. Levels for NNN and NNK would be set at the median value for the reported brands. Mandated limits for NNN, NNK, acrolein, carbon monoxide, acetaldehyde, benzo[a]pyrene, formaldehyde,1,3 butadiene, and benzene would then be announced. Beginning two years after the announcement of the mandated limits, brands with toxicant yields per mg nicotine exceeding the set levels would be excluded from import or sale.