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Regulatory Impact Analysis Statement for the proposed Cigarette Ignition Propensity Regulations and proposed Regulations amending the Tobacco Reporting Regulations
- Description
- Alternatives
- Benefits and costs
- Potential benefits
- Consultation
- Compliance and enforcement
- Contact
Description
The Department of Health is proposing regulations to address the public health problem resulting from cigarette-started fires. Smokers' materials are the leading cause of residential fires and fire-related losses in Canada each year. From an analysis of Canadian fire statistics for the years 1995 to 1999, the Canadian Association of Fire Chiefs reported that at least 14 030 fires were started by smokers' materials (including cigarettes, cigars and pipes). These fires killed 356 people, injured 1 615 people and cost more than $200 million in property damage. The victims of these fires are often among society's most vulnerable: children, the elderly and the financially poor.
The Department of Health is proposing that manufactured cigarettes be required to have a reduced likelihood of igniting upholstered furniture, mattresses and bedding in order to reduce the death and injury associated with such fires. The regulations would advance the purpose of the Tobacco Act by addressing one of the many facets of the national public health problem that is tobacco use.
Cigarette fires typically result from lit cigarettes left unattended, smoking in bed, or smoking while under the influence of alcohol, illicit drugs or medication. When a lit cigarette comes into contact with flammable products such as mattresses, bedding or upholstered furniture, it can start a smouldering process that can continue undetected for some time before bursting into flame. Smoke from the smouldering materials can render people in the vicinity unconscious, thus putting them at greater risk of injury or death from the ensuing fire. Given these facts, it is not surprising that residential fires started by smokers' materials result in a much higher fatality rate than fires started by other ignition sources.
The Department of Health has taken a number of steps to prevent such fires, including educating the public about the dangers of smokers' materials, establishing fire safety standards for consumer products such as mattresses and bedding, regulating ignition sources such as matches and lighters pursuant to the provisions of the Hazardous Products Act, and working with the Canadian Council of Furniture Manufacturers to implement voluntary flammability standards for upholstered furniture. Despite these efforts, fires started by smokers' materials continue to exact a significant toll on Canadian society by causing about 70 fatalities and 300 injuries every year. It is estimated that manufactured cigarettes are responsible for about 82 percent of these fires.
The ignition of a substrate (upholstered furniture, mattress or bedding) by a lit cigarette is a complex process that depends on the following factors: the characteristics of the substrate, the area of the burning cigarette coal, the speed of smouldering by the cigarette, and the zone of contact between the substrate and the smouldering cigarette. Ignition of a substrate occurs when the burning cigarette heats the substrate fabric or padding to the point where it begins to smoulder. A less ignition-prone cigarette either generates less heat (i. e. burns less fuel or restricts access of oxygen to the fuel) or heats the fabric less efficiently.
After reviewing more than 20 years of research, the Department of Health believes it is possible to reduce cigarette ignition propensity by altering certain design characteristics of manufactured cigarettes. Design alterations to reduce the amount of heat generated could include decreasing circumference, decreasing tobacco density and decreasing paper porosity. Decreasing the tobacco density and cigarette circumference would affect the amount of fuel (tobacco) available and decreasing paper porosity would restrict the flow of oxygen to the fuel. It is likely that a combination of these design changes would be required to meet the ignition propensity standard proposed in these Regulations.
In July 2000, a major American cigarette manufacturer released a reduced-ignition propensity version of one of its cigarette brands in the United States. In April 2001, it released a reduced ignition propensity version of the same brand in New Zealand. This product is made with a patented paper which has concentric bands of ultra-thin paper applied on top of traditional cigarette paper. The manufacturer claims that "These bands or rings act as 'speed bumps' to slow down the rate at which the cigarette burns as the lit end crosses over them." When tested by the U. S. National Institute of Standards and Technology, these cigarettes were found to have a significantly reduced ignition potential.
In December 2002, a consensus test method for measuring the relative ignition propensity of cigarettes was adopted under the auspices of ASTM International. This method is known as ASTM E2187-02b Standard Test Method for Measuring the Ignition Strength of Cigarettes. It is based on the Cigarette Extinction Test Method developed by the United States National Institute of Standards and Technology.
In this test, a lit cigarette is placed on a set number (three, ten or fifteen) of layers of standard laboratory filter paper. The filter paper acts as a heat sink for the burning cigarette. Once the cigarette coal has cooled to a certain temperature, it should self-extinguish. The more layers of filter paper used, the sooner the cigarette should self-extinguish. For each number of layers of filter paper, the procedure is repeated 40 times. Failure is defined as the cigarette burning its full length. The results are then presented as "percent full-length burns."
Generally, cigarette designs that perform well in the filter paper test have also performed well on full-size furniture or furniture mock ups, sometimes burning their full length without causing an ignition. Thus, the test estimates whether a cigarette would burn long enough and strong enough to cause ignition should it be dropped on a piece of furniture. For more detail, a copy of ASTM's E2187-02b: Standard Test Method for Measuring the Ignition Strength of Cigarettes (the filter paper method) can be obtained for a fee by contacting
ASTM International
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PA 19428-2959, USA
(610) 832-9585 (telephone)
(610) 832-9555 (facsimile)
www.astm.org
The Department of Health has used ASTM E2187-02b to test the ignition propensity of 62 brands of cigarettes sold in Canada. The brands tested were specifically chosen to be representative of the various designs and characteristics of cigarettes currently found on the Canadian market. Only one brand was found to have significantly reduced ignition propensity when tested using this method.
The proposed Regulations would require all cigarettes manufactured in or imported into Canada as of October 1, 2005, to burn their full length no more than 25 percent of the time during 40 replicate tests on 10 layers of Whatman no. 2 filter paper as described by ASTM E2187-02b. This performance standard prescribes an objective but allows manufacturers the freedom to use the manufacturing process or technical design of their choosing to achieve it. All cigarettes manufactured in Canada will have to meet the ignition propensity standard. Cigarettes manufactured for export have not been exempted, as doing so could be detrimental to Canada's reputation in the international community.
Further, in response to a concern raised by industry regarding the possibility of increased toxicity, proposed amendments to the Tobacco Reporting Regulations would require manufacturers and importers to perform annual toxicity testing on cigarette brands sold in Canada, both prior to and after the ignition propensity standard comes into force. Manufacturers and importers would be required to submit the results of these tests to the Department of Health on an annual basis.
At this time, insufficient information exists to mandate a standard for other tobacco products such as tobacco sticks, hand-rolled cigarettes or cigars. The Department of Health has begun research to determine the necessity and practicality of reducing the ignition propensity of other tobacco products. Since manufactured cigarettes account for about 86 percent of total cigarette and fine-tobacco sales in Canada, the Department of Health believes the proposed Regulations will have a significant impact on the number of fires started by smokers' materials and on their associated losses.
On December 31, 2003, New York State became the first jurisdiction in the world to mandate a standard to reduce the ignition propensity of cigarettes when it proclaimed its Fire Safety Standards for Cigarettes. By June 28, 2004, all cigarette brands sold in New York State will have to have no more than 25 percent full-length burns when tested using a modified version of ASTM E2187-02b.
Alternatives
A number of options were considered in the analysis of this issue as follows:
1. The status quo
Department of Health research has concluded that reducing the ignition propensity of cigarettes is possible and that an acceptable test method exists to measure cigarette ignition propensity. The Department of Health therefore feels it is in the public's interest to take action to reduce the ignition propensity of cigarettes.
2. Alternative standards
The Department of Health considered the strictest measurable standard of 0 percent full-length burns on three layers of filter paper and a less strict standard of 50 percent full-length burns on ten layers of filter paper as measured by ASTM E2187-02b. The standard of 25 percent full-length burns on ten layers of filter paper was chosen because it is the strictest standard demonstrated to be achievable and it is expected to result in a significant reduction in the number of cigarette fires in Canada. This is the same standard adopted by New York State.
3. Technical standard
The Department of Health considered mandating a technical standard whereby regulations would have stipulated how cigarettes must be manufactured to reduce their ignition propensity. Technical standards are often used in health and safety regulations but are known to potentially stifle the research and implementation of new designs that may be better than the originally prescribed technical specifications. For this reason, the Department of Health has chosen to mandate a performance standard which prescribes an objective but allows manufacturers the freedom to use the manufacturing process or technical design of their choosing to achieve it.
4. Voluntary agreement
A voluntary agreement with the cigarette industry was considered. However, previous voluntary codes within the tobacco industry did not prove to be successful in reaching the Government's health objectives.
Benefits and costs
Economic evaluation
This section of the Regulatory Impact Analysis Statement is a summary of the economic evaluation of the proposed Cigarette Ignition Propensity Regulations. For more details, please see the complete report posted on the Department of Health's Web site at http://www.hc-sc.gc.ca/hecs-sesc/tobacco/legislation/index.html.
Estimated manufacturing costs
To analyse the impact of the proposed Regulations on the cigarette-manufacturing sector, a baseline model of the cost structure for a representative cigarette manufacturer was first developed. The results of this model indicate that total manufacturing costs (i. e. before operating profits and taxes) for a representative cigarette manufacturer are approximately $5. 70 per carton. A two-part analysis was then used to estimate compliance costs: a modelled estimate and an estimate based on an industry outreach survey.
Both the modelled and the survey-based estimates include the following costs:
- manufacturing, quality assurance and other costs of compliance with the ignition propensity standard;
- toxicity testing and reporting as required by proposed amendments to the Tobacco Reporting Regulations;
- additional emissions tests and potential printing costs necessary to comply with the current Tobacco Reporting Regulations; and
- up-front research and development costs amortized over time.
For the industry outreach survey, questionnaires were sent to all known cigarette manufacturers and importers as well as a sample of other potentially affected parties including retailers, distributors, growers and unions. To facilitate response, an outline of the anticipated Regulations was included and the questionnaires were tailored to each sector; for example, the questionnaire for manufacturers included an estimated baseline cost structure for a representative cigarette manufacturer along with examples of possible changes in this cost structure as a result of the Regulations.
The intent of this exercise was to give stakeholders the opportunity to provide input on the potential costs and other impacts of the proposed Regulations. In total, nine responses were received from manufacturers (3), importers (3), unions (2) and retailers (1). However, only manufacturers and importers provided estimates of expected costs and these estimates varied. In order to ensure a reliable, upper cost bound, the survey-based estimate uses the highest values provided by stakeholders.
From this, the modelled estimate established the cost of compliance at $0. 126 per carton, while the survey estimated it at $0.257 per carton; this translates into annual costs of $26 million and $53 million, respectively. Using a discount rate of 3 percent, the present value would range from $867 million to $1. 77 billion assuming the costs would remain constant in perpetuity. As is the practice, a sensitivity analysis was conducted on alternative discount rates ranging from 1 percent to 10 percent. Further details of this analysis can be found in the complete report.
Compliance cost impacts on tobacco growers and paper suppliers, as well as impacts on trade and competitiveness, are expected to be marginal to the Canadian economy. Implementation of the proposed Regulations is not expected to impose additional costs on the distribution or retail sale of domestic cigarettes.
Potential benefits
Baseline fire loss estimates
The intent of the proposed Regulations is to reduce deaths, injuries and property damages resulting from fires started by manufactured cigarettes. Thus, the direct benefit of the proposed Regulations would be equal to the monetized value of the avoided health effects and property damage. The first step in assessing these benefits is to estimate the situation in the absence of control, or the baseline situation. To do so, this analysis uses annual reports of the Canadian Council of Fire Marshals and Fire Commissioners and data from Alberta and Ontario.
The Canadian Council of Fire Marshals and Fire Commissioners annually publishes reports providing national data on fire losses by ignition source. These reports indicate that smokers' articles (including cigarettes, cigars, and pipes as well as lighters and matches used in conjunction with smoking) caused an average of more than 3 200 fires per year from 1992 through 2000, and accounted for an annual average of 75 fatalities, 349 injuries, and $44. 7 million in property damage nationally during this period. The data also indicate that firefighters sustain 22 percent, and civilians, 78 percent of the injuries caused by fires started by smokers' materials. These percentages are used later in the analysis to separate firefighter injuries from civilian injuries for the purpose of valuing the potential benefits of the proposed Regulations.
Alberta is the only province that tracks cigarettes as a separate ignition source. For this reason, this analysis uses the Alberta fire loss data to adjust the national data to reflect fire losses attributable solely to cigarettes. This adjustment results in scaling factors of 75 percent for fires, 82 percent for fatalities, 76 percent for injuries and 73 percent for property damage. In addition, not all cigarettes are manufactured; Canadian sales data from 2002 indicate that approximately 86 percent of all cigarettes sold were manufactured. The remaining 14 percent were tobacco sticks or hand-rolled cigarettes. Since the proposed Regulations would mandate a standard for manufactured cigarettes only, the figures are further adjusted by a factor of 86 percent to account for fires ignited by manufactured cigarettes only.
Based on this, it can be estimated that, without the proposed Regulations, manufactured cigarettes would ignite approximately 2 085 fires in Canada each year, resulting in an average of 53 deaths, 227 injuries (51 firefighters, 176 civilians), and $28.1 million in property damage. These numbers form the baseline for the rest of the analysis.
National data on the nature and severity of civilian injuries associated with cigarette-related fires are limited. For this reason, the national data are supplemented with injury data from the Ontario Office of the Fire Marshal, which maintains information on the nature and severity of injuries sustained as a result of fires ignited by lit smokers' materials. Table 1 presents a summary of the results of an assessment of the Ontario injury data for 1995 through 2001.
| Nature and Severity of InjuryTable 1 footnote 1 | Percentage of Total Injuries |
|---|---|
| Asphyxia/ Respiratory Condition -Minor | 27.6% |
| Asphyxia/ Respiratory Condition -Serious | 17.7% |
| Burns or Scalds -Minor | 13.8% |
| Burns or Scalds -Serious | 11.4% |
| Other -Minor | 20.1% |
| Other -Serious | 9.4% |
| Total | 100.0% |
Notes: Table 1 footnotes
|
|
The data indicate that the most common injuries caused by fires started by lit smokers' materials in Ontario are asphyxia or respiratory conditions (45. 3 percent) and burns or scalds (25. 2 percent). Slightly fewer than 40 percent of the injuries reported are identified as serious. The analysis applies this information to characterize the likely distribution of injuries attributable to fires caused by manufactured cigarettes.
Estimated effect of the proposed Regulations
The benefit of the proposed Regulations would be the reduction in fire-related losses as a result of compliance with the ignition propensity standard. To estimate this potential benefit, two scenarios are used.
Scenario 1: 68 percent reduction in fires caused by manufactured cigarettes
This scenario is based on data indicating that the ignition propensity of cigarettes measured by ASTM E2187-02b correlates well with the ignition propensity of cigarettes established by bench-scale testing. Further, the 1987 U. S. Technical Study Group on Cigarette and Little Cigar Fire Safety (TSG) report found that ignition results in bench-scale furniture mock-up tests correlate strongly with ignition results using actual furniture. However, the relationship between bench-scale and full-scale tests indicates that the bench-scale test would underestimate the ignition of full-scale furniture by a factor of 1. 26. Thus, Scenario 1 assumes that the proposed standard of 25 percent full-length burns will result in a 68 percent reduction in cigarette-ignited fires and fire losses. This is considered the best-case scenario.
Scenario 2: 34 percent reduction in fires caused by manufactured cigarettes
By reducing the best-case scenario presented in Scenario 1 by 50 percent, Scenario 2 attempts to take into account factors such as easily ignitable fabrics, fires started in garbage cans or on paper instead of couches or beds, and the uncertain influence of air flows or crevices on ignition propensity. This is considered a lower-bound estimate.
Applying these percentages to the baseline numbers provided above, Scenario 1 would prevent 36 fatalities, 155 injuries (120 civilians, 35 firefighters) and $19.1 million in property damage per year. Similar figures for Scenario 2 would be 18, 77 (60, 17) and $9. 5 million, respectively.
The next step is to estimate the economic value of the potential reductions in fire losses. For property damage, no additional analysis is required since this loss is already expressed in monetary terms. In order to assign an economic value to the reduction in fatalities, the analysis uses a Value of Statistical Life (VSL) approach. This approach estimates a benefit of $5. 8 million per fatality avoided. The VSL estimate is based on an extensive review of the literature and is consistent with estimates the Department of Health has recently employed in other benefits assessments. Similar to the sensitivity analysis for discount rates, an uncertainty analysis of different VSL values was conducted. Further details can be found in the complete report.
A Health Care Cost (HCC) approach is used to value estimated reductions in injuries resulting from the proposed Regulations. This approach includes direct medical costs such as the costs of emergency transportation and care, hospital stays, medication, and doctor's visits. However, the approach does not estimate indirect costs such as an individual's willingness to pay to avoid a health effect or lost productivity, nor does it try to value intangible costs such as pain and suffering. The HCC is thus considered a lower bound of the economic valuation of illness or injury.
As no Canadian health care cost studies were found for health effects from cigarette-ignited fires, the cost of treatment estimates presented in Table 2 are based on a 1993 study of the societal costs of cigarette fires in the United States (Miller, et al., 1993)
| Severity of Injury | Category of Injury | ||
|---|---|---|---|
| Anoxia | Burns | Other | |
| Serious -Hospitalisation | 7,777 | 78,738 | 21,963 |
| Serious -No Hospitalisation | 1,072 | 1,072 | 791 |
| Minor | 151 | 151 | 151 |
Firefighters are less likely than civilians to sustain serious burns or other injuries as a result of a fire, since they approach the fire alert, well-protected, and well-trained. The U. S. study estimates a cost per injury of $1,679 for non-fatal injuries to firefighters. This amount is factored in the health care cost estimates.
The following table presents the estimated annual benefits of the proposed Regulations, generated by applying the VSL and HCC estimates to the estimated annual reductions.
| Reduction Scenario | Reduced Fatalities | Reduced Injuries | Reduced Property Damage | Total Benefits |
|---|---|---|---|---|
| Scenario 1 | 208.8 million | 0.2 million | 19. 1 million | 228.1 million |
| Scenario 2 | 104.4 million | 0.1 million | 9.6 million | 114.1 million |
The present value of these benefits depends on the discount rate employed and the anticipated duration of the benefits. For the purpose of regulatory analysis, the Department of Health generally employs a discount rate of 3 percent, which reflects current estimates of the consumption rate of interest. As costs were calculated into perpetuity, benefits and costs are calculated in the same fashion. Hence, the potential dollar value of the proposed Regulations' benefits would range from $7, 604. 1 million for Scenario 1 to $3, 802. 1 million for Scenario 2.
Net benefits
In aggregate, the benefits described above would exceed the estimated costs of the regulation by a factor of 2 or more. The following table shows the present value of the net benefits (i. e. benefits minus costs) for the scenarios presented above.
| Benefits Scenarios | Net Benefits | |
|---|---|---|
| Modelled Cost Estimate | Industry-based Cost Estimate | |
| Scenario 1 | 6,737.4 | 5,837.4 |
| Scenario 2 | 2,935.5 | 2,035.5 |
Distribution of costs and benefits
The tobacco industry and its customers would feel the primary impacts of the proposed Regulations. Ontario is Canada's largest tobacco producer, accounting for more than 90 percent of Canadian tobacco production. Quebec and Prince Edward Island produce most of the remaining tobacco.
If the cost of complying with the proposed Regulations were entirely absorbed by cigarette manufacturers, the companies' operating profits would be reduced by an estimated 2.9 to 5.9 percent. Alternatively, cigarette manufacturers could raise prices to reflect their increased costs. While some price increase is likely, the degree to which individual manufacturers would raise prices is uncertain, and would depend on competitive forces within the tobacco products market. Given the degree of competition in that market, it is unlikely that prices would rise by the full amount of the estimated cost increase (i. e. by $0.13 to $0. 26 per carton). Nonetheless, for purposes of bounding the potential economic impacts of the regulation, it is useful to consider this scenario.
Assuming an average baseline retail price (including all taxes and duties) of $65. 24 per carton, the addition of $0. 13 to $0. 26 would represent a retail price increase of 0.2 to 0.4 percent. Using a price elasticity of demand for adults of -0. 4, a 0.2 to 0. 4 percent increase in cigarette prices would be expected to result in a decline in demand of 0.08 to 0.16 percent, or a reduction in annual sales of 152 200 to 304 500 cartons. Geographically, costs passed through to consumers would likely be distributed by province roughly in proportion to the geographic distribution of the nation's cigarette smokers. Approximately 61 percent of cigarette smokers reside in Ontario and Quebec, thus a similar proportion of the costs of the proposed Regulations would likely accrue to residents of these provinces. The other provinces would account for a smaller share of total costs, in proportion to their share of the smoking population.
Although annual revenues from cigarette sales following the anticipated price increase would be expected to increase by $23.3 million to $46.5 million, this would not fully offset the increase in manufacturing costs. As a result, manufacturers' annual operating profits could be expected to decline by approximately $0.7 million to $1.3 million (i.e. 0.08 to 0.16 percent).
Cigarette manufacturers, tobacco growers, and distributors or retailers could experience some downward pressure on employment due to a decrease in cigarette sales. A study performed by the Department of Health in 1996 concluded that a decline in the demand for cigarettes would lead to a reduced demand for labour, especially in the retail, agriculture and tobacco products industries. However, when the impacts of this decline were reallocated to demands for other goods and services, it was predicted that the loss of jobs and income would be more than offset by increases in other sectors. It should be noted that between 1983 and 1998, the demand for tobacco products fell by 29 percent and there was an orderly adjustment.
The proposed Regulations would directly benefit segments of the population that might otherwise become victims of cigarette-ignited fires. This includes Canadians who smoke - an estimated 20 percent of the population aged 15 and over - and non-smokers who reside with them. Studies of fire damages in other countries indicate that approximately 40 percent of the victims of cigarette-ignited fires are non-smokers. According to the literature, victims tend to be those whose ability to respond to and escape from a fire is impaired. This includes the elderly, the very young, individuals with mental or physical disabilities, and individuals who are sleeping and/ or under the influence of drugs or alcohol. With respect to age, the Ontario data indicate that the elderly are disproportionately more likely to be killed in fires caused by lit smokers' materials. More than 27 percent of the fatalities involved individuals over the age of 70, a group representing only 9 percent of the population nationwide.
Data on the geographic distribution of cigarette-fire damages are unavailable. It is reasonable to assume, however, that the benefits of the proposed Regulations would be distributed by province roughly in proportion to the geographic distribution of the nation's cigarette smokers. Approximately 61 percent of cigarette smokers reside in Ontario and Quebec, thus a similar proportion of the benefits of the proposed Regulations would likely accrue to residents of those provinces. The other provinces would enjoy a smaller share of total benefits, in proportion to their share of the smoking population.
Consultation
A public consultation paper on possible regulation of cigarette ignition propensity was released on December 2, 2002. The document was mailed to more than 200 stakeholders and posted on the Department of Health's Web site. Forty-five responses were received from firefighters (30), non-governmental organisations (8) and the tobacco industry (7).
In October 2003, more than 40 letters were mailed to various affected parties, such as tobacco manufacturers, importers, retailers, growers and unions, inviting them to provide input into the cost assessment. The letters included an overview of the key elements of the regulatory proposal, as best as could be anticipated, along with a questionnaire intended to help respondents provide input. The questionnaires were tailored to each of the affected groups. In total, nine responses were received from manufacturers (3), importers (3), unions (2) and retailers (1). All relevant information received was incorporated into the cost-benefit assessment.
In addition, a number of meetings have been held with interested parties since January 2003.
The concerns raised during consultations, and the Department of Health's response, are summarised below.
1. Risk Behaviour
Some members of the tobacco industry indicated a need to further address the potential effects of reduced ignition propensity cigarettes on consumer fire-risk behaviour. To meet this need, it was suggested that the Department of Health
- include a process in the Regulations to monitor fire incidence and causation;
- be careful with potentially misleading terminology, especially the use of the term 'fire-safe; ' and
- lead a public education campaign on the matter.
The majority of other stakeholders dismissed the idea that reduced ignition propensity cigarettes would create a false sense of security among smokers. Many suggested that smokers already have a false sense of security and that is exactly why reduced ignition propensity regulations are needed. Others referred to the use of seat belts and air bags as examples of similar safety initiatives that have saved lives despite claims that people would become more careless. One stakeholder suggested that the introduction of reduced ignition propensity cigarettes might actually highlight the dangers associated with conventional cigarettes, thus increasing fire-risk consciousness. A few others suggested a need for restricting the promotion of reduced ignition propensity cigarettes entirely.
To address this issue, the Department of Health is conducting a baseline survey to determine the current fire-risk behaviour of smokers with regard to cigarettes. The intent is to repeat the survey once the Regulations are fully implemented and assess whether smoker behaviour has changed. In addition, the Department of Health is using data from the Ontario Fire Marshal to paint a statistical picture of a typical cigarette fire in Ontario. Once the Regulations have been fully implemented, the Department of Health will be able to perform a comparative analysis. This analysis will be useful as an indicator of possible behavioural changes.
The Department of Health agrees that the terms "fire-safe" or "self-extinguishing" are potentially misleading, since burning objects cannot be made completely fire-safe. Whether a cigarette will self-extinguish or not is partly dependent on conditions external to the cigarette itself. For example, it is unlikely that reduced ignition propensity cigarette legislation would have prevented the terrible forest fires that wreaked havoc on British Columbia in 2003. Such fires are normally preceded by prolonged periods of drought, creating conditions whereby the underbrush is easily lit. For this reason, the Department of Health has chosen to adopt the term "reduced ignition propensity."
The Department of Health does not plan to run any education campaigns about reduced ignition propensity cigarettes or the fire risk from cigarettes. However, it will continue to assess the need for such a campaign as the issue progresses.
2. The selected test method
The tobacco industry reported two concerns about the use of ASTM Method E2187-02b for measuring the relative ignition propensity of cigarettes: the method has no direct relationship to the real world, and the method has high inherent variability.
(A) The method has no direct relationship to the real world
To make this case, the tobacco industry often refers to (1) the use of filter paper as opposed to furniture mock-ups, (2) the inability to perform crevice testing and (3) the absence of an artificial airflow in the ASTM Method E2187-02b.
It is extremely rare, if not impossible, for a standard laboratory test in any scientific discipline to mimic the multivariate environments that exist in the real world. In developing methodologies, laboratory scientists strive to ensure that the parameter being measured is relevant and that the influence of other parameters is minimized.
Over the last 20 years, several attempts have been made to develop a method for measuring cigarette ignition propensity using furniture mock-ups made of fabric and foam. However, in order for a test to be useful for regulatory purposes, there must be a guaranteed, long-term supply of standard test materials of highly uniform quality. Since the material and foam used in the manufacture of furniture are highly variable and constantly changing, this consistency has proven extremely difficult to accomplish. Filter paper, on the other hand, is a product that is commonly used in scientific laboratories for a variety of purposes, and, thus, its supply can be guaranteed. Moreover, comparisons with ignition tests that use furniture mock-ups or full-scale furniture have shown good correlation with the filter paper method when tested on a variety of fabrics.
Some industry members have indicated disagreement with the above conclusion, even suggesting the possibility of "reversals," where a cigarette that does well in the filter paper test shows higher ignitions when placed on furniture mock-ups. However, the data cited to support this theory is somewhat unconvincing. For example, in such a study using furniture mock-ups with 500 randomly chosen fabrics, only six to ten of the fabrics actually showed a statistically significant "reversal" pattern and even this is questionable, since only six repetitions were performed for each furniture/ fabric combination. The minimum number of suggested repetitions for this method is 24.
Other studies reporting similar findings have used a much smaller number of fabrics and have only provided limited information on the fabric characteristics or how the fabrics were chosen. Furthermore, the variations in the characteristics of the cigarettes used for testing are quite limited and, in some cases, of questionable validity.
In the case of airflow and crevices, conflicting results have been found when these variables have been introduced into the test method. For example, higher ignitions have generally been observed when a conventional cigarette is placed in a crevice furniture mock-up as opposed to a flat furniture mock-up. Yet, in one recently published industry study, the crevice mock-ups produced consistently lower ignitions. These types of conflicting results exemplify the difficulty in reproducing a particular airflow or specific positioning of a cigarette in a crevice.
The ASTM E2187-02b Method is a good predictor of the ability of a cigarette to ignite substrates such as mattresses, upholstered furniture or bedding. A cigarette that meets the proposed standard, namely 25 percent full-length burns on ten layers of filter paper using this method, can be expected to have a much lower ability to ignite upholstered furniture, mattresses or bedding under most circumstances when compared with the majority of currently available cigarettes which have 100 percent full-length burns, even on 15 layers of filter paper.
(B) The method has high inherent variability
Nine laboratories, including four in the cigarette industry, showed that the United States National Institute of Standards and Technology method, upon which the ASTM E2187-02b Method is based, produced results that were repeatable and reproducible. A report published by the United States National Institute of Standards and Technology in July 2003 confirmed that results from its Cigarette Extinction Test Method and from the ASTM E2187-02b Method are consistent.
It is normal for scientific test methods to have a degree of variability. Considering the problem at hand, the Department of Health considers the variability of this method acceptable for the regulatory purposes of setting a cigarette ignition propensity standard.
3. Available technology
One tobacco industry member indicated that the banded technology used by a major American cigarette manufacturer does not work and cited an industry study that tested three different cigarettes on thirty-four fabrics as evidence. Unfortunately, full details on the fabric characteristics, such as cellulosic content or how the fabrics were chosen, were not provided. This information would be important in understanding why the average sodium plus potassium ion content of the fabrics used to test cigarettes with banded paper was almost double that of a random sample of 500 fabrics from an earlier study. Similarly, certain cigarette characteristics were not provided, such as tobacco type, presence or absence of tobacco additives and citrate content of the paper. Neither does the study explain the choice of cigarette characteristics, such as the 80 CORESTA units (cu) base paper used with the banded cigarettes versus the 33 cu paper of the non-banded cigarette.
The Department of Health is proposing a performance standard of 25 percent full-length burns on ten layers of filter paper using the ASTM E2187-02b Method. This approach leaves manufacturers free to use the manufacturing process or technical design of their choosing to achieve the standard. Thus, if manufacturers feel that banded paper has the potential to cause more fires, they may choose a different design.
In addition, the Department of Health is working with fire officials and other interested parties to improve fire data collection across Canada. This data, coupled with the planned analysis of the Ontario fire database, should provide a reliable measure of the impact of the proposed regulations on fires in Canada.
4. Toxicity
The tobacco industry indicated concerns that some methods of reducing the ignition propensity of cigarettes could increase the toxicity of cigarettes because of increased smoke deliveries (see 5, below). The industry also indicated that current toxicological evaluation methods are not adequate and that an appropriate toxicological testing program should be established prior to mandating a standard.
The majority of other stakeholders indicated that they feel it is the responsibility of cigarette manufacturers to ensure that reduced ignition propensity cigarettes are not more toxic than conventional cigarettes. Others suggested that further study is needed or that regulations should include a requirement for testing. One stakeholder felt that information from both a major American cigarette manufacturer and the US Technical Advisory Group for Cigarettes and Little Cigar Fire Safety had already demonstrated that toxicity was not an issue.
The Department of Health has amended the regulatory proposal to include a requirement for manufacturers to perform two short-term in vitro toxicity assays and report the results on an annual basis. The assays would be Health Canada Official Method T-501: Bacterial Reverse Mutation Assay for Mainstream Tobacco Smoke, First edition, dated 2004-01-30 and Official Method T-502: Neutral Red Uptake Assay for Mainstream Tobacco Smoke (Particulate Phase), First edition, dated 2004-01-30. Ideally, a battery of tests addressing several toxicological end-points should be used to monitor changes in smoke toxicity. However, relatively few toxicity tests have been validated and standardized for assessing the toxicity of tobacco smoke.
The purpose of requiring these toxicity tests and subsequent reporting of the results is to gather reliable toxicological data. The Department of Health is also working on a third official method (an in vitro Micronucleus Assay) for future incorporation by reference. The Department of Health anticipates that the data from these few assays will help it assess the potential changes in smoke toxicity.
5. Smoke chemistry
Industry has expressed concern that modifications to cigarettes to reduce ignition propensity could increase the toxic constituents in the smoke. In particular, one cigarette manufacturer indicated that carbon monoxide deliveries would be expected to increase by 10-15 percent. To put this increase in perspective, cigarette smoke contains over 4 000 chemicals, including more than 50 carcinogens. Most of the toxic chemicals in cigarette smoke, including carbon monoxide, benzene, formaldehyde and hydrogen cyanide, are created when tobacco burns. Others, such as nicotine, cadmium, lead and nitrosamines, are found naturally in unburned tobacco but are released as it burns.
The Department of Health is aware of only two published smoke chemistry studies conducted on reportedly reduced ignition propensity cigarettes, both by major American cigarette manufacturers. In the first one, the authors concluded that the paper used in these cigarettes caused only minor changes in chemical smoke composition. The second study concluded that, in comparison with the control cigarette, the modified (reduced ignition propensity) cigarette had similar or decreased deliveries.
Nevertheless, limitations in scientific knowledge at this time make it difficult to confidently assess the impact of any changes in smoke chemistry. The proposed regulations are designed to acquire additional information through the inclusion of new toxicity testing and reporting requirements coupled with the already established emissions reporting.
6. Consumer acceptability
The issue of consumer acceptability was brought up exclusively by members of the tobacco industry. The Department of Health believes that these types of studies are best left to the tobacco industry.
7. Other tobacco products
The proposed regulations only address manufactured cigarettes, which constitute about 85 percent of the tobacco product market in Canada. The majority of stakeholders have indicated support for this approach, though for different reasons. Industry stakeholders cited technical and methodological barriers while other stakeholders based their reasoning on the flammability risks and lower popularity of these other tobacco products.
Only one stakeholder, a tobacco industry member, indicated opposition to this approach. This stakeholder feels that people who do not accept reduced ignition propensity cigarettes may move to other tobacco products such as tobacco sticks or fine-cut tobacco (roll-your-own). This stakeholder reasons that, since people in lower socio-economic groups are most likely to use these other products, reduced ignition propensity regulations "would only exacerbate the vulnerability of this group."
The Department of Health is unsure how this conclusion has been reached. Firstly, these other products are not likely to have ignition propensities higher than those of conventional cigarettes. Thus, vulnerability is not likely to be increased. Rather, it is the opinion of many fire and flammability experts that the hand-rolled fine-cut tobacco products are already less of a fire hazard than current manufactured cigarettes. Secondly, this conclusion is based on the assumption that only those from lower socio-economic groups will reject reduced ignition propensity cigarettes to the point of seeking alternative products.
The Department of Health believes that the proposed Regulations will reduce the number of fires started by manufactured cigarettes and that its approach is reasonable given that manufactured cigarettes constitute about 85 percent of the tobacco product market. Further, the Department of Health has begun, but not yet completed, the necessary research on other tobacco products and may propose ignition propensity standards for these products at a later date. In the meantime, the Department of Health believes that if people do switch to alternate tobacco products their risk of fire will not increase beyond that posed by current manufactured cigarettes.
8. Illegal tobacco products
The tobacco industry also raised the concern that if consumers do not accept reduced ignition propensity cigarettes they will turn to illegal distribution methods to find non-reduced ignition propensity cigarettes. The Department of Health will continue to monitor the marketplace and to take appropriate action where illegal activities are observed.
9. Coal drop-off
Concern has been expressed by some tobacco industry members about the possibility of an increase in a phenomenon called "coal drop-off," where the lit coal at the tip of the cigarette falls off. If this happens, the burning coal could potentially leave a burn mark where it lands, whether on clothing, furniture or exposed skin.
The Canadian tobacco industry has not presented the Department of Health with any data to support its assertion that banded paper causes increased coal drop-off. The only information provided thus far are some pages from the preliminary proposed findings of fact from an ongoing court case in the United States. However, the documents do not contain any data to support either side of the debate on this issue and, as yet, the U. S. courts have not ruled on the case. For this reason, it is difficult for the Department of Health to use this information to make an informed decision.
However, a 1988 paper by researchers from British American Tobacco (U. K. & Export) Ltd. entitled The Influence of Cigarette Design on Coal Retention concluded that paper permeability had no influence on coal retention (within the range tested). Instead, the researchers found that tobacco characteristics had the largest influence on coal retention and, in particular, that an increase in expanded tobacco content above 40 percent increases coal retention. Interestingly, increases in expanded tobacco content are expected to reduce cigarette ignition propensity. The majority of Canadian cigarettes currently have expanded tobacco contents below 22 percent.
From this information, the Department of Health can only conclude that no evidence exists to confirm that meeting the proposed cigarette ignition propensity standard would necessarily result in increased coal drop-off.
Compliance and enforcement
Compliance monitoring and enforcement will be undertaken by the Department of Health under the authority of the Tobacco Act.
1. The ignition propensity standard
Section 5 of the Tobacco Act (the Act) stipulates that no person shall manufacture a tobacco product that does not conform with the standards established by regulations. In accordance with section 43 of the Act, every person who contravenes section 5 is liable, on summary conviction, to a fine not exceeding $100,000 or to imprisonment for a term not exceeding one year, or both; and on conviction on indictment, to a fine not exceeding $300, 000 or to imprisonment for a term not exceeding two years, or to both.
Compliance with the ignition propensity standard set out in the proposed Regulations would be monitored through sampling of cigarettes and subsequent analysis. Sampling would commence after October 1, 2005, and would target all cigarettes manufactured or imported into Canada.
2. Reports on toxicity testing
Section 6 of the Act requires every manufacturer and importer of a tobacco product to provide to the Minister of Health, in the prescribed manner and within the prescribed time, information about the product and its emissions, as required by regulations. Pursuant to section 44 of the Act, a manufacturer or importer who contravenes section 6 is liable on summary conviction to a fine not exceeding $50,000 or to imprisonment for a term not exceeding six months, or to both.
Compliance with the reporting requirement will be monitored through review of the reports received. Inspections will be undertaken at the manufacturing/ importing level to verify the accuracy and completeness of the information provided.
Contact
Ms. Christine Belle-Isle, Acting Manager, Regulations Division, Office of Regulations and Compliance, Tobacco Control Programme, Healthy Environments and Consumer Safety Branch, Health Canada, Address Locator 3507C1, 123 Slater Street, Ottawa, Ontario K1A 0K9, (613) 941-1551 (facsimile), pregs@hc-sc.gc.ca (electronic mail).
