Tobacco Reporting Regulations
Marginal note:Report
14 (1) Every manufacturer of a designated tobacco product shall report the information described in subsections (2) and (7), by brand and type of designated tobacco product, in respect of
(a) the emissions contained in the mainstream smoke produced from the combustion of the designated tobacco product; and
(b) the emissions contained in the sidestream smoke produced from the combustion of the designated tobacco product.
Marginal note:Content of report
(2) The report shall, in respect of the emissions contained in the mainstream and sidestream smoke produced from a cigarette, tobacco stick, kretek or equivalent unit of a designated tobacco product that is placed in a smoking machine and combusted, identify the emission and set out the mean, standard deviation and 95% confidence limit
(a) of the number of puffs;
(b) of each emission, expressed in milligrams, micrograms or nanograms per unit or equivalent unit; and
(c) of the weight of tobacco contained in the designated tobacco product expressed in milligrams per unit or equivalent unit.
Marginal note:Sampling
(3) A sample to be used for the purpose of determining the amount of an emission must be
(a) selected in accordance with the procedures described in items A and B of Table 1 of the International Organization for Standardization standard ISO 8243, second edition, dated 1991-10-15 and entitled Cigarettes — Sampling; and
(b) conditioned and smoked in an environment as described in the International Organization for Standardization standard ISO 3402, third edition, dated 1991-07-01 and entitled Tobacco and Tobacco Products — Atmosphere for Conditioning and Testing.
Marginal note:Replicates
(4) The mean, standard deviation and 95% confidence limit of the amount of each emission must be based
(a) in the case of tar, nicotine and carbon monoxide, on 20 replicates of a sample; and
(b) in every other case, on 7 replicates of a sample.
Marginal note:Method of collecting data
(5) Every manufacturer shall use the following methods to collect data for an emission:
(a) in the case of mainstream smoke, the applicable official method set out in column 2 of Schedule 2; and
(b) in the case of sidestream smoke, the applicable official method set out in column 2 of Schedule 3.
Marginal note:Conditions for the collection of data
(6) For the purpose of subsection (2), both of the following conditions are to be used to determine the amount of an emission:
(a) the conditions set out in the International Organization for Standardization standard ISO 3308, Third Edition 1991-10-15, entitled Routine analytical cigarette-smoking machine — Definitions and standard conditions, 1991 (E); and
(b) the conditions referred to in paragraph (a), but modified in the following manner:
(i) puff volume must be increased from 35 mL to 55 mL,
(ii) puff interval must be decreased from 60 s to 30 s, and
(iii) all ventilation holes must be blocked by placing over them a strip of Mylar adhesive tape, Scotch Brand product no. 600 Transparent Tape, and the tape must be cut so that it covers the circumference and is tightly secured from the end of the filter to the tipping overwrap seam, or by another method of equivalent efficiency.
Marginal note:pH levels
(7) The report shall also set out the pH level of the mainstream smoke, determined in accordance with Official Method T-113, entitled Determination of Mainstream Tobacco Smoke pH, made by the Department of Health, dated December 31, 1999.
Marginal note:When report to be submitted
(8) The report shall be submitted
(a) in the case of a report in respect of the emissions of tar, nicotine and carbon monoxide in the mainstream and sidestream smoke produced from the combustion of a cigarette or an equivalent unit of cigarette tobacco
(i) in relation to the conditions set out in paragraph (6)(b), for the period beginning on January 1 and ending on June 30 of a year, on or before July 31 of that year, and
(ii) in relation to the conditions set out in paragraph (6)(a), for the period beginning on July 1 and ending on December 31 of a year, on or before January 31 of the following year; and
(b) in the case of the report in respect of all other emissions in the mainstream and sidestream smoke or the short report referred to in subsection (9), annually on or before January 31 of the year following the year covered by the report.
Marginal note:Exception — short report
(9) A manufacturer may, instead of submitting the report described in subsection (1) for a designated tobacco product, submit, every two years, a report on the amount of tar, nicotine, carbon monoxide, benzene, hydrogen cyanide and formaldehyde emissions contained in the smoke produced from the designated tobacco product if
(a) in respect of cigarettes, cigarette tobacco and tobacco sticks, including any cigarettes, cigarette tobacco or tobacco sticks sold in kits, the manufacturer’s total sales for that product in the year preceding the period covered by the report is less than 1% of the total sales of that product in that year in Canada; and
(b) in respect of leaf tobacco and kreteks, the manufacturer’s total sales of that product in the year preceding the period covered by the report is less than 5% of the total sales of that product in that year in Canada.
Marginal note:Exception
(10) The report, other than a report in respect of the emissions of tar, nicotine and carbon monoxide, is not required for a designated tobacco product if
(a) the product is one of identical products of the manufacturer sold under different brands; and
(b) a report under this section is submitted in respect of another of those identical products.
Marginal note:Exemption — functional relationship of certain emissions
(11) A manufacturer may, on or before December 1 of the year preceding the year for which the exemption is sought, apply to the Minister for an exemption from the requirement to submit a report under subsection (1) in respect of the emissions for mainstream or sidestream smoke of a brand of a designated tobacco product specified by the manufacturer, if the manufacturer provides to the Minister the content and results of a statistical analysis done under the conditions referred to in subsection (12), that demonstrates, within a 95% confidence limit and in relation to the type of emission exemption sought, the existence of a functional linear relationship
(a) between tar and each of the other emissions, other than nicotine, produced from the combustion of the designated tobacco product
(i) by using the following formula:
y=mx+b
where
- y
- is the amount of the other emission,
- m
- is the slope,
- x
- is the mean amount of tar as determined by 7 replicates, and
- b
- is the intercept,
(ii) by applying a regression analysis to the results obtained under subparagraph (i), and
(iii) by applying an F-test to the results obtained under that subparagraph; and
(b) between nicotine and the other emissions produced from the combustion of the designated tobacco product, by making the calculation and applying the analysis and test described in paragraph (a), except that the references to “tar” in subparagraph (i), other than in the description of “y”, shall be read as references to “nicotine”.
Marginal note:Conditions
(12) The conditions under which the statistical analysis to be provided in subsection (11) are as follows:
(a) in the case of mainstream smoke, under the conditions set out in paragraphs (6)(a) and (b); and
(b) in the case of sidestream smoke, under the conditions set out in paragraph (6)(a).
Marginal note:Sample size
(13) To qualify for an exemption under subsection (11), the manufacturer must submit to the Minister
(a) a sample that must be composed of at least 28 different brands and 2 standard samples of a type of the designated tobacco product that represent the range of tar and nicotine deliveries for that type of designated tobacco product as determined
(i) in the case of mainstream smoke, in accordance with Official Method T-115, entitled Determination of “Tar”, Nicotine and Carbon Monoxide in Mainstream Tobacco Smoke, made by the Department of Health, dated December 31, 1999, and
(ii) in the case of sidestream smoke, in accordance with Official Method T-212 entitled Determination of “Tar” and Nicotine in Sidestream Tobacco Smoke, made by the Department of Health, dated December 31, 1999;
(b) a list of the brands of the designated tobacco product for which the application for exemption is made; and
(c) a list of the properties of the designated tobacco product, such as the type of tobacco, type of filter and characteristics of a cigarette paper, which demonstrate the functional linear relationship between
(i) the brands of the designated tobacco product that form the sample, and
(ii) one or more of the brands of the designated tobacco product for which the application for exemption is made.
Marginal note:Joint Sample
(14) For the purpose of subsection (13), two or more manufacturers may combine their designated tobacco products to produce a joint sample for the purpose of analyzing the sample in accordance with that subsection.
Marginal note:Decision of the Minister
(15) The Minister shall, without delay, decide to accept or reject
(a) an application made under subsection (11), based on the
(i) methodology used, and
(ii) the demonstration of a satisfactory functional linear relationship based on
(A) the mean and standard deviations of the amount of each of the emissions, other than tar and nicotine,
(B) the estimates and 95% confidence limits for the slope “m” and the intercept “b” referred to in subparagraph (11)(a)(i),
(C) regression statistics, including the degree of freedom for error, degree of freedom for regression, mean square regression, mean square error and the F statistic, and
(D) the fact that the data must fall under a 95% prediction interval; and
(b) a sample made in accordance with subsection (13) or (14), based on the methodology used and the representativeness of the sample.
Marginal note:Satisfactory functional relationship
(16) For the purposes of paragraph (15)(a), a satisfactory functional linear relationship exists if a linear model demonstrates a significant portion of the variation of the other emissions about the mean of those other emissions, with a statistical significance of less than 0.01.
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