Vol. 142, No. 22 — May 31, 2008

Regulations Amending the Tobacco Products Information Regulations

Statutory authority

Tobacco Act

Sponsoring department

Department of Health

(This statement is not part of the Regulations.)

Description

The Tobacco Products Information Regulations (TPIR) came into force in 2000. The TPIR establish the requirements for information that must be displayed on tobacco products that are for retail sale in Canada. These Regulations support the federal Tobacco Act (“the Act”) in providing a legislative response to a national health problem of substantial and pressing concern.

The TPIR set out specific requirements for graphics, size, location and content of information to be displayed—all aimed at ensuring that tobacco products display health warning messages, health information messages and information about their toxic emissions or constituents in a way that is easily legible, in a similar manner in both official languages and, where specified, in colour.

The Regulations Amending theTobacco Products Information Regulations (the “Regulations”) serve two main purposes: to respond to a review of the TPIR by the Standing Joint Committee on the Scrutiny of Regulations and to remove the obligation to list numerical values for toxic emissions.

Response to the review by the Standing Joint Committee on the Scrutiny of Regulations

The Standing Joint Committee on the Scrutiny of Regulations identified problems in the TPIR with respect to redundant language, clarity and consistency in both the English and French language versions, as well as to consistency between the English and French renditions and to errors in terminology.

The Regulations would amend section 1 of the TPIR by clarifying the following definitions:

— “health information” — modify the definition to clarify that words appearing in Part 4 of the source document that attribute the information to its source are not part of the definition;

— “health warning” — modify the definition to include reference to provisions that set out health warnings but are not currently referenced in the definition, specifically health warnings for bidis (a thin cigarette of tobacco rolled in a dry leaf, usually made in South Asia), chewing tobacco and snuff, and to clarify that words appearing in Parts 1, 2 and 3 of the source document that attribute the information to its source are not part of the definition;

— “manufacturer” — modify the definition to exclude the words “includes an importer of tobacco products” — the words are redundant in that the concept of importing of tobacco products is already in the definition of “manufacture” found in the Act;

— “slide” — modify the definition to reflect accurately its use in other sections of the Regulations — this clarifies that slide is part of a “slide and shell” package; and

— “source document” — modify the definition in order to provide reference to an amended version of the document Health Warnings and Information for Tobacco Products—the source document has been amended to correct several minor errors and omissions.

Section 1 would also be amended to add the following definition:

— “identical products” — this definition would support the new wording in subsection 8(2) to describe which tobacco products are exempted from the requirements for toxic constituent testing.

The Regulations would amend subsection 4(1) by clarifying that manufacturers who wish to attribute health warnings or health information can find the information required by this section for such an attribution in the source document.

The Regulations would amend section 5 by deleting the word “cigares” (subsection 5(1), French version only), by clarifying that the formats for display of health warnings, except in the case of bidis, chewing tobacco and snuff, be selected from the formats set out in the source document—not, as is currently stated, from formats provided by the Minister (paragraph 5(2)(d)), and by clarifying that the requirement for equal display of health warnings applies to each type of package of each brand (subsection 5(7)).

The Regulations would amend paragraphs 6(1)(a) and (b) to change the word “surface” to “side” to provide consistency with the terminology used in the first paragraph of subsection 6(1).

The Regulations would amend subparagraph 7(1)(a)(i) by deleting the word “extérieur” (French version only) and by clarifying provisions for equal display of health information on leaflets (subsection 7(3)) in English by aligning the wording more accurately with the French version.

The Regulations would amend section 8 by deleting the reference to section 5 (alternative methods) of the Tobacco Reporting Regulations as applying to testing for toxic constituents required by the Tobacco Products Information Regulations (subsection 8(1)) and by deleting the references to subsections 14(3) (emissions - sampling) and 14(4) (emissions - replicates) of the Tobacco Reporting Regulations (subsection 8(1)) as well as the reference to section 9 of the Tobacco Products Information Regulations, as the methodology for determining quantities of toxic emissions would no longer be required with the removal of the requirement for this information to be displayed on packages (see the last paragraph of “Obligation to Display Numerical Values in the Toxic Emissions Information” following). The Regulations would also clarify the wording to describe which tobacco products are exempted from the requirements for toxic constituent testing (subsection 8(2)).

The Regulations would amend section 11 by clarifying the requirements for the height of characters to be used in the printing of toxic emissions and toxic constituents information on packages (paragraph 11(b)), as the phrase “in a pitch of 10 points” was not correct terminology. The marginal note in the English version would be improved to provide a better description of the section.

The Regulations would amend section 12 by removing the phrase “Subject to subsection (3)” (subsection 12(1)) as this phrase is unnecessary and by clarifying that the requirement for equal display of health information applies to each brand (subsection 12(3)).

In addition to the above, the French rendition of the term for a “slide and shell package,” “paquet à coulisse,” was made consistent throughout the Regulations. Also, in the French version, the term “information” has been replaced by the term “renseignements” where health warnings and health information are referred to jointly.

Obligation to display numerical values in the toxic emissions information

The toxic emission information displayed on packages of certain types of smoked tobacco products was originally intended to provide smokers with information on six compounds found in the smoke they inhale to help them gain a better understanding of the health risks associated with the use of tobacco products (there are more than 4 000 compounds found in tobacco smoke).

Currently, numerical values have to be displayed on the side of packages of five types of smoked tobacco products, for six toxic substances found in the smoke of these products. The five types of tobacco products are cigarettes, cigarette tobacco, kreteks (a tobacco-and-clove cigarette, usually made in Southeast Asia), leaf tobacco and tobacco sticks; whereas the six toxic substances are tar, nicotine, carbon monoxide, formaldehyde, hydrogen cyanide and benzene.

The toxic emission values are expressed as a range, with the lower number determined according to smoking conditions set in a method from the International Organization for Standardization (ISO) and the higher number by the same method but with modified smoking conditions (e.g. larger puff volumes). As no two people smoke the same way, it was reasoned that providing a lower and upper value of the yields for various toxic emissions would provide a better indication of the potential amounts of toxic substances a person might inhale.

The Department of Health has had research conducted which indicates that the numerical values for toxic emissions that currently appear on tobacco product packaging are not clearly understood by some smokers. In a 2003 study, most participants stated that they “have no idea” or “don’t really know” what the numbers mean. Participants were also confused about whether the numbers referred to dose per cigarette or per package of cigarettes and the presence of a range of numbers made many of them question the accuracy of the numbers. A second 2003 study found that most people had little idea what the range of numbers for each chemical meant. People also questioned the accuracy of the large range of measurements. As a result, many people concluded that the numbers did not really mean anything. Only 17% of participants understood that the toxic emission values are related to the fact that some smokers may take in larger amounts of a chemical while other smokers may take in less.

In 2002, the Scientific Advisory Committee on Tobacco Products Regulation of the World Health Organization (WHO) recommended that tar, nicotine, and carbon monoxide numerical ratings not be displayed.

Based on the above, the Regulations would remove the requirement to have the toxic emission values displayed on affected tobacco product packaging. As a result, the list of six toxic emissions would still remain but without the numerical values.

Internationally, Canada would join Australia, Brazil and Venezuela, which have already removed the obligation to display toxic emission values on tobacco product packaging. It should be noted that many countries, including the United States, do not require toxic emission values to be displayed on tobacco product packaging.

The Regulations would thus amend section 9, as well as clause 13(1)(c)(ii)(B), by eliminating the requirement for information on the amount of each toxic emission. Concurrently, the Regulations would also repeal Schedule 1, which describes the official methods for the collection of data on toxic emissions, and the definitions in section 1 for “equivalent unit,” “mainstream smoke” and “toxic emission,” which are no longer required.

The Regulations would provide for a transition period of 18 months during which time the unamended TPIR would continue to apply to tobacco product packages and any accompanying leaflets that are in accordance with that version. This provision would allow tobacco product packages that have been printed before the proposed amendment comes into force to be sold through the system.

Alternatives

Given the nature and purpose of the proposed amendments to correct problems identified by the Standing Joint Committee on the Scrutiny of Regulations, no alternatives were considered.

Regarding the toxic emissions information, various requirements have been implemented since 1989. A recent consultation, held in 2004, proposed new approaches and sought public input on the type of information to be displayed. Further to this consultation, the Department of Health is continuing the development of a new concept in this area. In the meantime, the Department believes that the recommendation of the WHO should be followed and that the removal of the obligation to display the toxic emission values is the most appropriate public health measure to implement. Several alternatives were considered.

(1) Status quo

The toxic emission information displayed on packages of certain types of smoked tobacco products was originally intended to provide facts to smokers to help them gain a better understanding of the health risks associated with the use of tobacco products. However, in light of the recommendations from the WHO and of Department of Health research indicating that many people do not understand the toxic emission values, it is a reasonable conclusion that those values should be removed while the list of six toxic emissions should remain.

(2) Public education campaign

A public education campaign to explain how to interpret the toxic emission values was examined as an alternative. However, this option was not retained given the challenge of explaining the complexity of the smoking process to the general public and considering that the toxic emissions values would still not be reliable as a source of information about individual exposure.

(3) Voluntary removal of toxic emission values

The voluntary removal of the toxic emission values by industry is not an option because the inclusion of both the six toxic substances and their corresponding numerical toxic emission values is a current regulatory requirement.

Benefits and costs

The amendments in response to the Standing Joint Committee on the Scrutiny of Regulations are cost neutral.

The removal of the obligation to display toxic emission values would better align Canadian regulations with current international expert opinion on the provision of information on toxic emissions and remove information from tobacco packaging that may be confusing and not understood by smokers.

While there would be no new costs to the federal government as a result of the proposed Regulations, the tobacco industry would incur costs because of changes required to the packaging of tobacco products, and it could be anticipated that these costs would be passed on to consumers.

Industry costs related to modifications of the health information messages

Health information must be displayed on or in the packages of several types of tobacco products. The products are cigarettes (other than cigarettes contained in a soft package), cigarette tobacco (other than cigarette tobacco contained in a pouch), kreteks, leaf tobacco and tobacco sticks. The health information must be printed on the package or on a leaflet inserted in the package. For slide and shell packages, the health information must appear on the slide part of the package or on a leaflet. Leaflets must also be placed in cartons of cigarettes contained in soft packages.

The amendment of the Source Document includes minor changes to five of the sixteen health information messages, three affecting both the slide and shell and the leaflet versions, one affecting only the slide and shell version and one affecting only the leaflet version.

The two major tobacco companies that manufacture tobacco products in Canada use a rotogravure process to print their packages, including the slide part of slide and shell packages. Rotogravure printing requires the use of cylinders which have been engraved with the information to be printed. For the slide and shell packages, the revisions to four health information messages would require one new cylinder for each message, for a total of four cylinders per company. The estimated maximum cost per cylinder is $10,000. Therefore, the total cost for engraving the new cylinders is expected to be about $40,000 per company, for a total of about $80,000 for the two companies.

Other tobacco companies manufacturing tobacco products in Canada usually use techniques such as lithography or laser printing to print the slide and shell parts of their packages, and all manufacturers use techniques like these to print leaflets. The costs for these manufacturers to change the four health information messages, on both packages and leaflets, would be much less than the costs of engraving cylinders.

In addition, inventory-related costs would be mitigated significantly through the provision of an 18-month transition period that would allow tobacco product packages that have been printed before the proposed amendment comes into force to be sold through the system.

The maximum total costs for the revisions to the health information messages are expected to be less than $150,000.

Industry costs related to the removal of the obligation to display toxic emission values

The costs to the tobacco industry associated with the removal of the values from the toxic emission information have been extrapolated from the response of one major manufacturer to a survey carried out on behalf of the Department of Health in 2006. Taking into account recent changes in tobacco manufacturing in Canada, it is estimated that the costs of the modifications to tobacco product packaging would be approximately $9,300,000. This estimate does not include inventory-related costs which would be mitigated significantly through the provision of the 18-month transition period that would allow tobacco product packages, printed before the proposed amendment comes into force, to be sold through the system.

If the additional packaging costs were to be passed on to consumers, the retail price of a package of cigarettes would be expected to increase by less than one cent.

Conclusion

The removal of the obligation to display toxic emission values will remove information from tobacco packaging that is not understood by smokers. This in turn will mean that smokers will have better information about the chemicals in tobacco smoke and a better understanding of the health risks associated with the use of tobacco products.

The benefit of this regulatory proposal to the health of Canadians clearly outweighs the economic costs to the tobacco industry which can be recouped through a very small increase in the cost of a package of cigarettes.

Consultation

A public consultation paper entitled “Building on Success: A Proposal for New Health-related Information on Tobacco Product Labels” was released in August 2004 and widely disseminated through a mailing to the tobacco industry, non-governmental organizations, public interest groups, professional organizations and others, as well as through posting on the Health Canada Web site. This paper included a proposal to replace the current toxic emissions information with a series of statements that would present clear and concise information about the toxicity of each of eight substances found in tobacco smoke (six substances are mentioned presently), including its health effect and its range of toxic emission values. It was suggested in the proposal that these statements could be equally distributed amongst tobacco product packaging. Respondents from non-governmental and governmental organizations supported the proposal, with four recommending that the range of toxic emission values be removed. Respondents from the tobacco industry generally neither supported nor opposed the proposal although they emphasized that the information should be objective and fairly presented.

Further to this consultation, the Department of Health is continuing its comprehensive review; this proposed amendment is a first step. Tobacco manufacturers were advised of the proposed amendment in face-to-face meetings in 2006 with Health Canada management and offered no written comments. Further changes to the toxic emissions information are being explored and may include amending the information as described in the consultation document noted above.

Compliance and enforcement

Compliance with these requirements would be monitored through inspections at the retail and manufacturing/importing levels that would be undertaken to ensure that all changes, including those affecting the toxic emission values, have been made in accordance with these amendments, taking into account the transitional period.

Interested parties are invited to seek further information on this proposal, by writing to

Mr. Cameron Laing
Regulatory Policy Analyst, Tobacco Control Programme
Healthy Environments and Consumer Safety Branch
Health Canada
Address Locator 3507C1
123 Slater Street
Ottawa, Ontario
K1A 0K9
Fax: 613-941-1551
Email: pregs@hc-sc.gc.ca