BMJ Publishing Group

Revising the machine smoking regime for cigarette emissions: implications for tobacco
control policy
Author(s): David Hammond, Friedrich Wiebel, Lynn T Kozlowski, Ron Borland, K Michael
Cummings, Richard J O'Connor, Ann McNeill, Greg N Connolly, Deborah Arnott, Geoffrey T
Fong
Source: Tobacco Control, Vol. 16, No. 1 (February 2007), pp. 8-14
Published by: BMJ Publishing Group
Stable URL: http://www.jstor.org/stable/20748095 .
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 8

REVIEW

Revising themachine smoking regime for cigarette emissions:

implications for tobacco control policy
Wiebel, LynnT Kozlowski,Ron Borland,KMichael Cummings,Richard
David Hammond,Friedrich
JO'Connor, AnnMcNeill,Greg N Connolly,DeborahArnott,
GeoffreyT Fong
TobaccoControl2007;16:8-14. doi: 10.1136/tc.2005.015297

Background: TheWHO FrameworkConvenion on Tobacco Control includes provisions for testingand

regulating cigarette emissions. However, the current international standard for generating cigarette
emissions?the ISO machine smoking regime?is widely acknowledged to be inappropriate forpurposes
of settingregulatoryrestrictions.
See end of articlefor Objective: To review alternatives to the ISO machine smoking regime and the extent towhich they: 1)
authors' affiliations
Represent human smokingbehaviour, 2) Reduce the potential for industry exploitation, particularly in the
area of riskcommunication,and 3) Serve as suitablemeasures forproduct regulation.
Correspondence to: Methods: Emissionsdata from238 Canadian cigarettebrands testedunder the ISO and "Canadian Intense"
D Hammond,HealthStudies machine
& Gerontology,University of smoking regimes.
200 University
Results: None of the alternative smoking regimes, including the Canadian Intensemethod, are more
Waterloo,
Avenue West, Waterloo, "representative" of human smokingbehaviour and none provide betterpredictorsof human exposure.
Ontario,Canada N2L 3G1; Conclusions: Given that alternatives such as the Canadian Intense regime are subject to the same
dhammond@uwaterloo.ca as the ISO regime, keyquestions need to be addressed before any smoking regime
fundamental limitations
Received 1December2005 should be used to set regulatory limitson smoke emissions. In themeantime, regulators should remove
Accepted 17August2006 quantitativeemission values fromcigarettepackages and more work should be done on alternativemachine
smokingmethods.

The issue of how to test and regulate conventional cigarettes Article 9.13These provisions will need to be specified now that
represents a critical challenge for tobacco control. To date, the FCTC has come into force.After discussions with theWHO,
the primarymeans of testing cigarette toxicityhas been to the ISO convened a working group (ISO TC 126 WG9) to
machine smoke the cigarettes according to a standard puffing develop recommendations for "...a robust and practical
regime and to measure the chemical emissions in the main smoking regime that as far as possible is representative of
stream smoke. In many jurisdictions, these cigarette "yields" smokers' behaviour". Meanwhile, the World Health
are printed on packages and represent the only source of Organization's Study Group on Tobacco Product Regulations
information on constituents or toxicity available to consumers. (WHO TobReg) has developed itsown set of recommendations,
Cigarette emissions also serve as a regulatory standard in which were under consideration by the ISO Working Group.14
several of jurisdictions, including the European Union, where There are also concerns that the ISO committee structure
brands that generate emissions >10 mg of tar, 1mg of nicotine responsible for setting tobacco standards is dominated by the
or 10 ppm of carbon monoxide are prohibited. tobacco industry.12
The puffing regime used tomachine smoke the cigarettes? Before any new testing regime is implemented, it is critical to
the International Organization for Standardization (ISO) ensure that the new standards will serve the interestsof public
regime1?is widely recognised to be inadequate for the purposes health rather than the tobacco industry.The purpose of this
of product regulation or consumer information. The ISO regime paper is to review the smoking regimes that are under
constitutes a set of puffing parameters that systematically consideration by the ISO Working Group, and to examine the
underestimate smoking behaviour in humans.2"4 Tobacco implications for tobacco control policy and product regulation.
manufacturers have also designed brands to perform In particular, we examine the extent to which the proposed
cigarette
one way under themachine smoking conditions, but to deliver regimeswill: (1) succeed in "representing" smoking behaviour
6
much greater smoke constituents to humans.5 As a result, the in humans and generate better predictors of human exposure;
emissions generated under the ISO smoking regime have little (2) reduce thepotential for industryexploitation, particularly in
relationship with actual measures of human exposure, and the field of risk communication; and (3) help to establish more
exaggerate the differences between brands in a manner that effective regulatory limits on cigarette toxicity.
has proved deceptive to both consumers and regulators.7-9
Overall, the emissions from the ISO regime have served as SMOKING BEHAVIOUR INHUMANS
more of an industrymarketing tool to falsely reassure health
The ISO Working Group seeks tomake themachine smoking
concerned smokers, rather than as a valid measure of cigarette
regimen more representative of smoking behaviour in humans.
toxicity.210-12 This will undoubtedly involve a more intensive set of puffing
There is a growing movement to develop a more meaningful
machine testing method. The World Health Organization's Abbreviations: FCTC, Framework Convention on Tobacco Control; ISO,
Framework Convention on Tobacco Control (FCTC)?the International Organization for Standardization; NNK,
world's first international public health treaty?includes provi WHO TobReg, World
4(methylnitrosamino)-l-(3-pyridyl)-1-butanone;
sions for testing and regulating cigarette emissions under HealthOrganization'sStudyGroup on Tobacco ProductRegulations

www.tobaccocontrol.com
 Revising themachine smoking regime 9

900 Table 1 International

Organization forStandardization
800 smoking regime and potential alternatives
700 Puff Filter
Smoking Puff
volume frequency blockage Flowrate
"ob 600 regime* (ml) (s) (%)
(ml/s)
g 500 ISO 35 60 0 17.5
A 55 30 50 27.5
I 400 Option
Option B 60 30 50 30

300 Option C 45 30 100 22.5

I Option D 55 30 100 27.5
to 200
*Alloptions include International
Organization forStandardization (ISO)
100 puffdurations (2 s) and butt length (filter+8mm).
0
0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1
smokes all brands using the same puffing profile regardless of
Nicotineyield (mg)
their product design. As a result, highly ventilated brands?
which are smoked more intenselyby humans?generate much
Figure 1 Population-based estimates of nicotine uptake versus lower emissions under machine This creates a
testing.
International Organization for Standardization (ISO) nicotine yield.7
misleading ranking of brands that is an artefact of the smoking
machine and isnot a reflectionof the actual smoking behaviour
than the current ISO to ade
parameters regime. However, of humans. Indeed, the ISO regime operates on principles that
quately represent smoking behaviour in humans, the new are opposite to those of smoking behaviour inhumans: whereas
regimemust not simply be more intense; itmust also reflect human puffingvaries across brands and nicotine uptake is kept
a fundamental of
compensatory smoking, aspect smoking relatively constant, the ISO smoking regime holds puffing
behaviour in humans.10 constant across brands and produces variable nicotine emis
Smoking behaviour in humans is primarily driven by sions.
nicotine. People smoke to achieve a particular nicotine dose
and will adjust their smoking behaviour tomaintain this dose
across products.1516 Therefore, smokers increase the number PROPOSED ALTERNATIVESTO THE ISO SMOKING
and intensity of their puffs when switching to a brand that
REGIME
generates a lower nicotine emission under the ISO machine The ISO Working Group considered four alternative smoking
conditions.17-19 regimes, all of which can be characterised as more intensive
smoking
variants of the current ISO standard (table 1).
Figure 1 shows the considerable individual variation in
nicotine intake among smokers, as published by Jarvis et aV The WHO TobReg committee has endorsed Option D, on the
Some people are simply lighter smokers and pursue lower levels grounds that it comes closest to representing the "maximum
of nicotine, whereas others who smoke the same brand have exposure level towhich an ordinary smoker could reasonably
higher nicotine needs and either smoke a greater number of be expected to be subject when smoking...".14 Option D has

cigarettes or smoke each cigarette more intensely. already been implemented in Canada20 and is typicallyreferred
No single standard smoking machine test can reflect the to as the "Canadian regime".1
individual variation in nicotine uptake among smokers. Most Figure 2 shows the nicotine yields for 238 Canadian brands
brands recruita heterogeneous group of smokerswith different tested under the Canadian Intense regime, compared with ISO
nicotine uptakes to the extent that the average nicotine uptake nicotine yields for the same brands.22 On average, the nicotine
is similar across brands. Indeed, there are no marked emissions more than double under the Canadian regime (ISO
differences in nicotine uptake across brands at the population mean 0.9 v Canadian mean 2.3 mg, p<0.001), whereas tar
level: individuals who smoke a lower ISO emission product emissions (not shown) almost triple (ISO mean 10.7 v
have similar nicotine uptake as those who smoke higher Canadian mean 30.5 mg, p<0.001).'
8
emission products.7 Figure 2 illustrates the high correlation between the nicotine
To achieve similar nicotine uptake across brands, some emissions generated by the Canadian brands and the nicotine
brands need to be smoked more intensely than others. This is emissions generated by the ISO regime (r= 0.75, p<0.001).
true for an individual smokerwhen switching brands, as well However, the range of nicotine emissions under the Canadian
as at the population levelwhen comparing smokers of different Intense regime is proportionally less than the range produced
brands. under the ISO regime: there is a twofolddifferencebetween the
A recent review of smoking topography among people highest and lowest nicotine emissions under the Canadian
smoking theirusual brands found that brands with lower ISO regime, compared with a 15-folddifference in the ISO nicotine
tar emissions were smoked more intensely than brands with emissions.

higher ISO tar emissions.4 In other words, there are systematic A recent study examined the extent to which nicotine
differences in how certain brand designs are smoked by emissions from the ISO regime and the Canadian regimewere
consumers. associated with nicotine a sample of Canadian
uptake among
Overall, there are few differences in human uptake either smokers. Neither set of nicotine emissions was markedly
between smokers using different brands or within a smoker related to salivary cotinine, a reliable measure of nicotine
when switching products. Ultimately, it is the smoker who uptake; in fact, the correlation coefficient between nicotine
determines the delivery of a product and the product that
determines the puffing behaviour necessary to achieve that
'Although the Canadian regime has been called a "maximum" smoking
delivery. regime, it is not. Rather, the puffing parameters for the Canadian regime
For cigarette emissions to have any association with (55ml puffsdrawn every 30 s) are closer to mean human puffing
levels of human machine parameters, even for low-ventilated brands. For example, a recent study or
population exposure, smoking Canadian smokers recorded an average of 52 ml puffs for the three most
regimes must reflect the systematic differences in puffing
popular brands, all of which
were low-ventilated brands (mean ventila
behaviour across products. Unlike humans, the ISO regime tion=5%, n=17).21

www. tobaccocontrol. com

 10 Hammond,Wiebel, Kozlowski, et al

Therefore, the different "maximum" values generated under

the Canadian method do not represent differences in the
"maximum" values of human use.
One strategy for addressing compensatory smoking and,
presumably, for making cigarette emissions more relevant to
human behaviour is to classify cigarettes on the basis of their
25
smoke toxin:nicotine ratios.24 For example, rather than

setting a limit on the absolute emission of potent lung

carcinogens such as NNK, limitswould instead be set on the
NNK level/mg of nicotine. If smokers "titrate" for nicotine,
then brands with lower toxin:nicotine ratios may deliver fewer
toxic constituents to smokers as they seek to reach their
nicotine dose.
The use of toxin:nicotine ratios appears to be gaining
momentum as a potential
regulatory strategy.14 This would
represent an improvement on the use of cigarette emissions as a
measure of exposure, but only if the toxin:nicotine ratios
remained constant across the range of nicotine emissions.
However, as Kozlowksi and O'Connor10 have previously noted,
versus toxin:nicotine ratios are not fixed, but in response to
Figure 2 Canadian International Organization for Standardization change
(ISO) nicotineemissionsfrom238 Canadian brands. smoking conditions.26 Toxin:nicotine ratios can also obscure

important differences in the absolute value or "mass" of

uptake and the Canadian nicotine emissions (part r = 0.16, nicotine and other smoke constituents. For example, the

p>0.05) was even lower than the correlation for the ISO Canadian regime generates nicotine emissions that range from
nicotine emissions (part r= 0.24,
p>0.05). In short, the 1.5 to 3.2 mg for Canadian brands. Therefore, under the
emissions from the Canadian are no more related to Canadian regime, the NNK:nicotine ratios are based on nicotine
regime
human than are the ISO emissions.22 emissions as low as 1.5 mg for some brands and as high as
uptake
The other three smoking regimes proposed in table 1have yet 3.2 mg for others. To compare NNK ratios from similar doses of
to be evaluated by scientists independently of the tobacco nicotine?that is, to ensure that the denominator in the

industry.Although we currently lack the data to examine these NNK:nicotine ratio is constant across brands?some brands

regimes in detail, data from the Canadian and Massachusetts would need to be smoked more intensively than others. Doing
regimes (45-ml puff volumes, 30-s puff frequencies and 50% so will change the NNK:nicotine ratio in many cases. For
vent blocking)23 suggest that each of the three alternative example, compared with the ISO regime, the NNK:nicotine
methods will have a similar, though more modest effect on ratios of Canadian brands tested under the Canadian method
emissions than the Canadian Intense regime, owing to less decrease by as much as 29% for some brands and increase by as
intensive puffing parameters or the reduced filterventilation much as 63% for others.22 In fact, the NNK:nicotine ratio has
blocking. Although each of the testing regimes will help to been shown to change by as much as 240% across smoking
"characterise" how a product performs under a given set of for some international brands.27 Thus, the toxin:
regimens
conditions, none of the smoking nicotine ratios under the Canadian Intense
smoking regimes "represent" generated regime do
human behaviour in terms of compensatory smoking and none not reflect differences between brands when used
necessarily
is likely to produce emissions thatwill be markedly associated by consumers. If nicotine emissions in machine are
smoking
with human exposure or risk, either for individual smokers or in the same way as smokers the nicotine ratios
equalised do,
for population-level differences between brands. would change considerably.
In a sense, the differences between the machine emissions

CIGARETTEEMISSIONS AS REGULATORYLIMITS and uptake among populations of human smokers?which for

nicotine is essentially constant across brands?can be consid
The Canadian smoking regime was not developed to represent
behaviour in humans. it was to ered a type of measurement error. The Canadian Intense regime
smoking Rather, designed
emissions under a more intensive set of smoking does little to reduce this measurement error relative to the
generate
parameters that would provide a "maximum" exposure limit existing ISO regime. This may not be terriblyimportant if the
that could be exceeded by very few smokers. Consistent with differences between brands for a particular emission are

this rationale, the WHO TobReg has proposed using the sufficiently large. example, For NNK:nicotine levels show more
emissions from the Canadian method as a standard metric than a 10-fold difference across brands in different markets,
from which "upper limits" on emissions could be set. To ensure and a sixfold differencewithin the Canadian market (fig 2).28
that the emission reductions are technically feasible, theWHO The differences inNNK:nicotine are sufficientlylarge that a 10
TobReg recommends using the range of emissions from brands fold difference cannot be attributed simply to how cigarettes
already on the market to set limits (eg, brands with perform under a set of machine smoking conditions and is
- to have for human
4( methylnitrosamino) -1 (3 -pyridyl) -1 -butanone likely implications exposure.
(NNK)rnicotine levels above themean for a particular market However, few emissions show the same variability as NNK.
would be prohibited). For example, as fig 3 shows, the levels of benzene/mg of
The concept of an intensive testing regime is intuitively nicotine exhibit only a twofold difference between the lowest
appealing because itminimises the likelihood that themachine and highest levels among Canadian brands. This presents a
emissions will underestimate human exposure. This approach challenge for settingupper limitson emissions: as the range of
also avoids the impossible task of trying to predict individual toxin:nicotine ratios decreases, so too does the difference
levels of exposure using machine testing methods. between brands thatwould fall above an emission limit and
Nevertheless, as shown above, "intensive" regimes produce be prohibited, and those thatwould remain on themarket. The
differences in emissions that are an artefact of the testing distinction between brands becomes smaller and the "measure
regime and are not associated with in humans. ment error" of the machine becomes more
smoking testing regime

www.tobaccocontrol.com
 Revising themachine smoking regime 11

120.00 =o 120.00
o
o
_c
0 100.00 E 100.00
E
c o
g o
"T5
O 80.00 80.00
c
D
u
60.00 o 60.00
o
o o o o

40.00 Or 40.00
S n CP O &C
CD
CD o o E o ?o
E
20.00 o cP ? 20.00
a>
Z N
c
Z
0.00 2 o.oo
_L _L _L _i_ _L _L _L _L _L _L _L J_
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40
Nicotinemg/cigarette(ISO method) Nicotinemg/cigarette(ISOmethod)

Figure3 of nicotine
Levelsof toxins/mg amongCanadian cigarette
brands:4(methylnitrosamino)-l -butanone(NNK)and benzene (n= 89).
-(3-pyridyl)-l

prominent. In other words, it is unclear whether these smaller reductions in human For if regulators wish to
uptake. example,
differences have any relationship with smoking behaviour in place a limit on NNK:nicotine ratios using existing brands on
humans orwhether they are simply artefacts of how cigarettes the market, differences in NNK uptake could be examined
are smoked under machine conditions. within an individual after a switch from a "high" to a "low"
In addition, not all constituents change to the same extent or NNK.nicotine product. Unless the NNK biomarker (NNAL) is
even in the same direction under testing regimes?for different considerably lowerwhen brands below theNNKinicotine limit
example, the NNK and benzo[a]pyrene:nicotine ratios decrease are smoked, there is no evidence that the regulatory limitwill
under more intense puffing conditions, whereas the nicotine reduce NNK exposure among humans. One important con
ratio for carbon monoxide increases, as does the overall sideration for this researchwill be to establish what constitutes
tarmicotine ratio.22 It is unclear to what extent certain a "meaningful" reduction in human exposure.
emissions can be reduced independently of others. information on the "physical"
Secondly, design parameters
Manufacturers have also shown their skill in substantially of products must be collected, as recommended by theWHO
reducing machine emission levels through subtle design TobReg.14 Cigarette emissions are most meaningful when
changes. Recent evidence from the UK suggests that tobacco considered within the context of these design parameters,
manufacturers have adhered to the "10?1?10" limits on ISO which can be manipulated in various to alter machine
ways
emissions simply by increasing the level of filterventilation so emission levels. For example, filter ventilation is almost
that brands provide deceptively low readings under machine 33
perfectly correlated with ISO levels of tar and nicotine.32
conditions.29 Filter ventilation is the most prominent, but by no ISO standards exist for several
already design parameters,
means the only design change available tomanipulate yields. filter ventilation, filter efficiency, draw resistance and
including
An additional concern about the use of toxin:nicotine ratios paper porosity.34Public health regulators should implement
is that currentproposals fail to take into account the proportion mandatory reporting requirements for these physical design
of unprotonated or "free" nicotine. Total nicotine, as measured to better understand the interaction between
parameters
on the Cambridge filterpad aftermachine smoking, contains and smoke constituents, as well as to evaluate
product design
both monoprotonated and "free" nicotine. The proportion of how regulatory limitsmay drive changes in brand design.
of a product
Thirdly,patterns of use must be examined to understand the
"free" nicotine affects the sensory perceptions (eg,
"impact") as well as the location and rate of nicotine interaction between product design and smoking behaviour in
31
absorption.30 Thus, regulatory limits for toxin:nicotine ratios and to identify differences across
humans, systematic products.
that fail to take into account the proportion of "free" nicotine Products that deliver fewer toxins fora fixed volume of smoke
may be missing a key element underlying compensatory and also smoke intake when used
promote greater by
smoking behaviour. consumers are not lower-risk that
products. Likewise, products
deliver higher amounts of toxins, but discourage repeated use
BUILDING THE EVIDENCE BASE FOR PRODUCT might potentially be seen as harm reducing compared with
REGULATION conventional cigarettes. Measures of realistic puffing behaviour
We consider product regulation to be an important aspect of and inhalation patterns are, therefore, important for under
tobacco control, and reducing cigarette emissions may have a standing different chemical and biological profiles associated
role in this process. However, the existing evidence base must with products.
be broadened in three critical fields to direct regulatory strategy More generally, the public health community must find a
and to evaluate the public health potential of these initiatives. way to develop evidence-based product regulation without

Firstly,machine emissions should be considered within the setting the evidentiary threshold so high that itacts as a barrier
context of biomarkers of human exposure. Unless some to action. Fortunately, the types of research outlined above are
consistent relationship can be established between emission well within the capacity of public health scientists.The tobacco
standards and levels of exposure (as indicated by biomarkers), industry can also have an important role in developing this
emission limits are unlikely to reduce risk. In some cases, evidence base. Although independent research in these fields is
biomarker studies can be conducted before regulatory limitsare critical, manufacturers should be required to report product
introduced to help identify the magnitude of reductions in information, including emissions, contents, physical design
machine smoked emissions that are necessary to bring about parameters and patterns of use as a condition for selling their

www. tobaccocontrol. com

 1 2Hammond,Wiebel, Kozlowski, et al

products. Manufacturers are already collecting these data for human exposure. At the same time as they insist that cigarette
their own product development and testing purposes (eg, the emissions are not measures of risk, various regulators continue

PhilipMorris "total exposure study"35),and should be required to use cigarette emissions in ways that assume a link between
tomake these data public. Canada has already implemented a the machine emissions and human exposure.39 Many jurisdic
range of reporting requirements?including reportingof indus tions continue to require that quantitative levels of tar, nicotine

try research activities?that may serve as a model for other and carbon monoxide appear on packages. These numbers

jurisdictions.36 continue to be misunderstood and misused by smokers,

including smokers in themost affluent and highly educated

To is no that
MACHINE SMOKING REGIMES:
ALTERNATIVE countries in the world.2 date, there evidence
emissions constitute effective consumer informa
COMPENSATORY REGIMES quantitative

As outlined above, the fundamental limitation of the current tion, and several scientific bodies have rightly called for the
38
removal of these emissions from In our view,
ISO testing regime and the regimes under consideration by the packages.14

ISOWorking Group is that they are inconsistentwith smoking continuing to print emissions on cigarette packages would
in humans. In our view, ifmachine are to be
contravene the spiritofArticle 11 of theFCTC, which states that
smoking regimes
tobacco packaging and labelling "...shall not promote a tobacco
more representative of smoking behaviour in humans, they
that are ... or
must overcome this deficiency. The first attempt in this product by any means misleading, deceptive
likely to create an erroneous impression about its character
direction has been made by Kozlowski and O'Connor,10 who
istics, health hazards or emissions".13
recommended adjusting the smoking regime so that brands effects,

are more For routine consumer information, non-numerical descrip

with lower ISO nicotine emissions smoked intensely.
tive information on smoke constituents should on
For example, with each 0.1 mg decrease in ISO nicotine appear
as is the case in Brazil, Venezuela and
emission, the puff volume and puff frequencywould increase packages, already
Australia. It is critical to evaluate such descriptive-based
by a set amount in a subsequent round of machine testing. A
as well as other means of
smoking regime of this typewould avoid most of the biases approaches, communicating
caused by regimes operating with a fixed set of puffing constituent information to smokers. In addition, the tobacco

parameters. industry should be prohibited fromusing machine emissions in

Recently, a variation on thismodel has been proposed, which any of its labelling, advertising or marketing directed at
to mimic to a consumers, even if accompanied by "warnings" or disclaimers,
strives patterns of human smoking greater
this regime, the puffing parameters of the such as those that currently in the US and
extent.11Under appear Europe.39
machine are set to reach a fixed nicotine In A change in smoking regimes does not justify a change in
smoking "target".
other words, different brands would be machine smoked to this position. The ISO emissions numbers are not deceptive to
the same nicotine within a narrow level of consumers simply because they are too low, but because they
generate emission,
tolerance. Thus, each would have a tailored set of exaggerate the differences between brands. Each of the
product
puffing parameters required to achieve this emission.111 proposed regimes, including the Canadian regime,will produce
This is generally consistent with in a range of emissions that will be equally susceptible to
smoking behaviour
humans, where the smoker determines the nicotine delivery, exploitation by the tobacco industryand misunderstanding by
maintains this delivery across products, and it is the product the consumer. Simply changing the metric of cigarette
that determines the puffingbehaviour necessary to achieve this emissions provides little insurance against the likelihood that
This would toxinmico consumers will interpret "lower-emission" brands as lower
delivery. compensatory regime produce
tine ratios that could be compared across brands without bias risk.
for certain designs, and may thereforebe more suitable for
establishing regulatory limits. CONCLUSIONS
Compensatory regimes also need to address the fact that The current ISO testing regime is an inappropriate standard for
toxinmicotine ratios may vary under different smoking
evaluating cigarette toxicityand setting regulatory restrictions
intensities.10 Thus, brands should be tested from time to time,
on cigarettes. All four of the alternatives by ISO TC 126WG9
if not routinely, at multiple nicotine targets representing the
have the same fundamental limitations as the existing ISO
range of smoking intensity inhumans. Testing brands at both a to generate in ways that are
regime: they continue emissions
"high" and a "low" nicotine target would allow regulators to
inconsistent with smoking behaviour in humans.
detect shifts in toxin:nicotine ratios and to control for them.
The ISOWorking Group has now completed itswork and the
There is a need to test this alternative regime to determine its
larger ISO TC 126 committee recently agreed to delay final
feasibility. on a new until recommendations for Article 9 of
voting regime
the FCTC are developed. The onus is now on the public health
CONSUMER INFORMATION community to determine the most appropriate method for
After nearly 40 years?and after great cost to public health? emission testing.As only a progress report is planned for the
the public health community is now coming around to the second FCTC conference of the Parties in 2007, guidelines for
realisation that lower ISO emission cigarettes are not lower-risk machine testingmay not be put forward until 2008, at the
products. Unfortunately, many regulators fail to understand the earliest. This timeline provides a window for the public health
distinction between "product characterisation" and predicting to consider alternatives to the Canadian Intense
community
regime thatmay provide a better basis for setting regulatory
"Wiebel FJ, Kozlowski L, Hammond D, et al. A novel machine smoking limits.
regime for establishing regulatory limitsof toxic smoke constituents. World The remains whether emissions from any machine
question
Conferenceon Tobacco or Healtti; 13-17 July2006,WashingtonDC. can serve as an effective standard. The
testing regime regulatory
"The different smoking parameters?puff volume, frequency, duration and "precautionary principle" suggests that the level of toxic
filter blockage?can be combined in several ways to achieve the same emissions in cigarette smoke should be reduced to the extent
nicotine yield. These machine parameters would, therefore, need to be
varied in a systematic way across brands to reach the nicotine "target".
possible, regardless ofwhether a public health benefit can be
demonstrated. Yet, the benefits of emission need to
Forexample, to reach thenicotinetarget, mightbe varied
pufffrequencies regulations
of 4 s and puffvolumesby 5 ml, keepingventilation
by intervals blocking
be weighed against the broader opportunity costs. Emission
and puff duration constant. limits will require considerable resources to and
implement

www.tobaccocontrol.com
 Revising themachine smoking regime 13

monitor, resources that may exceed the current capacity of

regulators. There are also concerns that emission limits would What this paper adds
Most important,it is
exempt tobaccomanufacturers fromliability.
uncertain how consumers will respond to emission regulation.
The Framework Convention on Tobacco Control includes
Despite clear scientific statements to the contrary, consumers may provisions for testing and regulating cigarette emissions.
interpretemission limitsas an indication that cigarettes are less However, the current internationalstandards for generating
harmful?much in the same way that they have interpreted cigarette emissions?the ISO machine smoking regime?is
emission reductions in the past.2 In fact, futureemission limits widely acknowledged tobe an inappropriatemethod forsetting
may be evenmore likelytoundermine perceptions of risk than in regulatory restrictions.This paper reviews the alternative
the past: "new" emission reductions would be based on a smoking regimes thatwere considered by the ISOWorking
"superior" machine method, would be more comprehensive in Group WG9 and theWorld Health Organization, and
examines the implications for tobacco control policy and
scope, and may have the formalendorsement of theWorld Health
Organization through the FCTC. One can also envision how product regulation. In particular, we examine the extent to
manufacturers consumer which theproposed regimeswill:
might shape response through packa
ging and marketing. Overall, regulations that achieve modest succeed in behaviour inhumans
reductions in smoke toxicitybut result in fewerquitters ormore "representing" smoking
and generate better predictors of numan exposure
initiators are not effective policy measures.
None of these opportunity costs argue against regulating reduce thepotential for industryexploitation, particularly
tobacco products. However, theydo suggest that theminimum in the fieldof riskcommunication
threshold for interveningmay be greater than the precau help to establish more effective regulatory limitson
tionaryprinciple alone. cigarette toxicity
Key questions need to be addressed to evaluate whether
emission limitsmeet this threshold and are appropriate foran
FCTC standard. How many emissions will be targeted? Limits
that only apply to only a few toxic constituents in tobacco comprehensive reporting requirements for cigarette emissions
that may serve as a template for other
smoke have littlechance of reducing a product's risk.However, jurisdictions.14
Finally, we would urge international agencies to consider a
regulating a long list of emissions increases the complexity and framework forestablishing an independent product testingand
cost of implementing the standards. Will emission limits be
monitoring laboratory.We stronglysupport the development of
progressively lowered over time? If so,what is theultimate end theWHO Tobacco LaboratoryNetwork, butwith the addition of
point?Most within the public health communitywould argue an international independent laboratory that could oversee this
that there are no meaningful differences in risk between
work.42 This independent laboratory should be charged with
conventional cigarette brands to begin with. So long as this is
the case, there is little or no point in making distinctions collecting and archiving tobacco products, conducting routine
between brands that are already on themarket. In the end, only product testing and maintaining a database of product-related
information from cigarette manufacturers. A license fee
limits that reduce the emissions well below currentmarket
charged to cigarette manufacturers could finance the opera
standards or interferewith the palatability of cigarettes
tions of this laboratory.We would urge theWHO to also
(including the draw "mechanics" of product) have the consider the appropriate structure formanaging the data and
potential for significant public health benefit.41 Therefore,
making itpublicly available to the scientificcommunity. Such a
emission limitsmay be effective only when used as "blunt"
framework would help scientists to incorporate product
regulatory tools formandating substantial changes across all information into studies of human exposure, as well as to help
products. Finally, how should the recent findings on free
regulators draw comparisons between brands in different
nicotine be incorporated into emission limits that express markets. This data repositorywould be particularly valuable
toxins permg of nicotine? If theproportion of "free" nicotine is for low-income parties and middle-income parties to the FCTC
not fixed, free nicotine should serve as a
perhaps separate that lack the capacity and resources tomanage the data that
denominator.
would be required under Articles 9 and 10 of the FCTC.
As regulatory proposals for reducing emissions evolve,
Together, these initiativeswould provide an evidence base to
regulators can take immediate and meaningful action in several direct and evaluate product regulation. In themeantime, we
related areas. We endorse the need to make informa
strongly would encourage public health scientists to develop the
tion on cigarette emissions public to advance the evidence base
capacity for alternative machine testing regimes, including
foreffectiveproduct regulation; however, this is not to say that those that are more consistent with smoking in humans, as
quantitative emissions should be communicated directly to well as othermechanisms forevaluating toxicity.In the longer
consumers. Emission numbers should be removed from term,we also believe that a comprehensive testingprogramme
packages in jurisdictions where they are currently required should be extended to cover the effectof all tobacco products,
and limitations on the use of quantitative emissions should be
including smokeless tobacco, and that such products should
established before any new smoking regime is adopted. also be brought under a common and coherent system of
Regulators can also implement comprehensive reporting regulatory control.
standards, which would require manufacturers to report We thank Neil Collishaw and Murray Kaiserman for their comments on

physical design parameters and measures of human exposure. earlier drafts of this manuscript.
We would also encourage regulators tomandate more specific
reporting standards for smoke emissions. "Tar" is not a

homogeneous substance, and its use as a measure of toxicity

Authors' affiliations
obscures critical differences in the amount and importance of D Hammond,HealthStudies& Gerontology,University
ofWaterloo,
Waterloo, Ontario, Canada
individual chemicals in tobacco smoke.Manufacturers should
FWiebel, Formerly
of the Institute
of Toxicology,
GSF-NationalResearch
be required to report individual smoke constituents, including Center for Environment and Health, Neuherberg, Germany
"free" and known classes of carcinogens such as, but LTKozlowski,Department
nicotine, Health,ThePennsylvania
ofBiobehavioral State
not limited to, tobacco-specific nitrosamines and polynuclear University; University Park, Pennsylvania, USA
aromatic hydrocarbons. Canada has already introduced R Borland, The Cancer Council Victoria, Melbourne, Victoria, Australia

www.tobaccocontrol .com
 14Hammond,Wiebel, Kozlowski, et al

K M Cummings,R JO'Connor, Department of HealthBehavior,Roswell 15 Benowitz N. Compensatory smoking of low-yield cigarettes. Risks associated
with smoking cigarettes with lowmachine-measured yields of tarand nicotine.
ParkCancer Institute; New York,USA
Buffalo,
Bethesda, MD: US Department of Health and Human Services, Public Health
A McNeill, School ofCommunityHealthSciences,Universityof 2001:39-63.
of Health; National Cancer Institute,
Services, National Institutes
Nottingham, Nottingham,UK 16 Smith TA. Compensation by smokers forchanges incigarette smoke composition.
G N Connolly,HarvardSchool of PublicHealth,Divisionof PublicHealth 24 Mar 1972. London: British American Tobacco, 1972, Bates No.302057575/
Practice, Boston, Massachusetts, USA 7579. http://www. library.ucsf.edu/tobacco/
Actionon Smokingand Health,London,UK
D Arnott, batco/html/8600/8663/index.html (accessed 20 October 2006).
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G T Fong,Departmentof Psychology,
University of smoke exposure. Pharmacol Biochem Behav 1990;37:29-39.
Ontario, Canada
18 Ahijevych K, Gillispie J.Nicotine dependence and smoking topography among
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ROI CA 100362 and throughthe
of theUnitedStates (through
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Roswell Park Tobacco Use Research P50 20 Health Canada. Determination of "tar", nicotine and carbon monoxide in
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