Strategies for regulation of
cigarette emissions
The WHO product regulatory approach
Nigel Gray
David Burns
For TobReg Working Group 1 in
Conjunction with IARC
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.
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.
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.
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.
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.
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.
Table 1. Toxicants recommended for mandated lowering
Toxicant
NNK
NNN
Level in
micrograms per
mg nicotine
international
brands*
Level in
Criteria for selecting the value
micrograms per
mg nicotine
Canadian
brands**
0.072
0.114
0.047
0.027
Acetaldehyde
860
670
Acrolein
83
97
Benzene
48
50
0.011
0.011
Benzo[a]pyrene
1,3-Butadiene
Carbon
monoxide
67
53
18400
15400
Formaldehyde
47
97
Median value of the data set
Median value of the data set
125% of the median value of the
data set
125% of the median value of the
data set
125% of the median value of the
data set
125% of the median value of the
data set
125% of the median value of the
data set
125% of the median value of the
data set
125% of the median value of the
data set
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.
Effect on the Market
Maximal Limit Percentile:
100
By 90
By 80
By 70
By 60
By 50
75
50
25
eh
yd
e
e
Fo
rm
al
d
xi
d
M
on
o
C
ar
bo
n
A
cr
ol
ei
n
re
ne
ap
y
ne
Toxicant
B
en
zo
B
en
ze
eh
yd
e
A
ce
ta
ld
B
ut
ad
ie
ne
0
1,
3
Percent of Brands Remaining
Proportion of Brands Remaining After Constituents Removed By Percentile in Order of
Their Cancer Index
International Brands, Canadian Intense
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.
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.
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.
Uses Other Than
Mandated Lowering
BENZOAPYRENE yield per Mg Nicotine In Canadian Brands
NNN and NNK by Brand for Canadian Cigarettes
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.
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
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
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
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
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.
Ranking of Toxicants in Smoke with Respect to
Toxicant Animal Carcinogenicity Indices
Counts et al.
means
Canadian
means
Australian
means
Means of
means
1,3-Butadiene
11.4
8.9
9.5
9.9
Acetaldehyde
7.0
5.7
5.5
6.1
Isoprene
4.6
2.9
3.6
3.7
NNK
4.7
3.8
1.8
3.4
Benzene
2.7
2.8
2.4
2.6
Cadmium
1.6
2.4
1.2
1.7
Acrylonitrile
1.7
1.4
1.2
1.4
Hydroquinone
1.1
1.3
1.2
1.2
Catechol
0.49
0.75
0.50
0.58
NNN
0.55
0.22
0.10
0.29
8.2E-3
9.6 E-3
8.1 E-3
8.6 E-3
2-Aminonaphthalene
0.81 E-3
0.77 E-3
0.47 E-3
0.68 E-3
1-Aminonaphthalene
0.49 E-3
0.32 E-3
0.28 E-3
0.36 E-3
0.00
0.00
0.00
0.00
Toxicant
Benzo[a]pyrene
Lead
Ranking of Toxicants in Smoke with Respect to
Toxicant Non-Cancer Response Indices
Toxicant
Acrolein
Acetaldehyde
Formaldehyde
Hydrogen cyanide
Nitrogen oxides
Cadmium
1,3-Butadiene
Acrylonitrile
Carbon monoxide
Benzene
Toluene
Arsenic
Methyl ethyl ketone
Ammonia
Phenol
Mercury
Styrene
m- + p-Cresol
o-Cresol
Counts et al. means Canadian means
1127
77.2
13.7
22.7
5.0
2.4
2.7
2.5
1.5
0.66
0.24
0.16
0.09
0.11
0.06
0.04
0.02
0.01
0.01
1188
62.9
25.8
15.9
2.2
3.6
2.1
2.0
1.2
0.68
0.24
0.06
0.09
0.03
0.01
0.02
0.01
Australian
means
983
61.1
20.0
13.0
2.1
1.8
2.3
1.8
1.1
0.57
0.18
0.07
0.05
0.06
0.00
0.01
0.00
Means of
means
1099
67.1
19.8
17.2
3.1
2.6
2.4
2.1
1.3
0.64
0.22
0.16
0.08
0.07
0.07
0.02
0.02
0.01
0.01
Toxicants to be Reported
Toxicant
Acetaldehyde
Acrolein
Acrylonitrile
4-Aminobiphenhyl
2-Aminonaphthalene
Benzene
Benzo[a]pyrene
1,3-Butadiene
Cadmium
Carbon monoxide
Comments
Catechol
Crotonaldehyde
TACI 0.58
Aldehyde with reactive alkene structure, lacks TL value, inadequate evidence of
carcinogenicity
Formaldehyde
Hydrogen cyanide
Hydroquinone
Nitrogen oxides
NNN
NNK
TNCRI 19.8
TNCRI 17.2
TACI 1.2
TNCRI 3.1
Identified in Part 1
Identified in Part 1
TACI 6.1, TNCRI 67.1
TNCRI 1099
TACI 1.4, TNCRI 2.1
Human carcinogen, but not experimental data for T25 calculation
TACI 0.68
TACI 2.6
TACI 0.01
TACI 9.9, TNCRI 2.6, Group 1 Human carcinogen
TACI 1.7, TNCRI 2.6
Relatively low TNCRI, but mechanistically related to endothelial dysfunction in
cardiovascular disease
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.
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.
Marlboro LS F HP/Argentina
0
Brand
1R4F Kentucky Reference
1R4F Kentucky Reference
Merit KS F SP Ultima/US
Philip Morris KS F HP Super Li
Chesterfield KS F HP Lt/EU
Marlboro KS F HP Lt/Norway
Marlboro 100 F HP Lt/US
Peter Jackson KS F HP Men/Aust
Marlboro KS F HP/Brazil
Raffles 100 F HP/EU
Marlboro KS F HP/Mexico
Virginia Slims 100 F HP Men 1
Longbeach One KS F HP/Australi
Muratti KS F HP Ult 1 mg/CEMA
Philip Morris One KS F HP/EU
Virginia Slims 100 F HP Ult Me
Diana KS F HP Ult/EU
Marlboro KS F HP Ult/EU
Philip Morris 100 F HP Super L
Chesterfield INTL KS F HP Ult/
Virginia Slims 100 F HP Ult Me
Parliament KS F HP Lt/Japan
Marlboro KS F HP Ult Men/US
Merit KS F SP Ult/US
Marlboro 100 F HP Lt/Germany
Marlboro KS F HP Lt/Japan
Marlboro KS F HP Lt/Germany/UK
Parliament 100 F SP/CEMA
Merit KS F HP/EU
Muratti Ambassador KS F HP/EU
Diana KS F SP Specially Mild/E
Chesterfield Originals KS F HP
F6 KS F HP Lt/EU
L & M KS F HP Lt/EU
Marlboro KS F HP/Japan
Parliament 100 F SP Lt/US
Marlboro KS F HP Medium/EU
Marlboro 100 F HP/EU
Marlboro KS F HP/Taiwan
Marlboro KS F HP 25 s/Australi
L & M KS F HP/Malaysia
Chesterfield Originals KS F HP
Marlboro KS F HP/Malaysia
L & M KS F HP/EU
Marlboro KS F HP/Norway
Marlboro KS F SP/US
Petra Regular F HP/CEMA
SG Ventil Regular F SP/EU
Marlboro LS F HP/Venezuela
Percentage of teh Median Value of Brands
Selection of 125% Level
Benzo[a]pyrene per mg Nicotine Yields by Brand as a Percentage of the Median Yield
for Philip Morris International Brands
1.8
1.6
1.4
1.2
1
0.8
0.6
0.4
0.2