Regulations Amending the Tobacco Reporting Regulations

Amendments

1. The definition "identical products" in section 1 of the Tobacco Reporting Regulations is replaced by the following:

"identical products"
« produits identiques »

"identical products" means tobacco products that

(a) contain identical ingredients;

(b) are manufactured in an identical manner;

(c) have identical dimensions; and

(d) perform in an identical manner under the same conditions.

2. The Regulations are amended by adding the following after section 1:

Application

1.1 Every provision of these Regulations that applies to a brand of tobacco product also applies to every size of that brand.

3. Subsection 2(2) of the Regulations is replaced by the following:

Information gathering analysis

(2) Every report made under Parts 2, 3, 4 and 5 shall be based

(a) on data obtained from the analyses of tobacco products performed during the period to be reported on; or

(b) on activities undertaken by or on behalf of the manufacturer during that period. Collecte et analyse des données

(2) Les rapports exigés par les parties 2, 3, 4 et 5 sont fondés :

a) soit sur les données recueillies lors d'analyses de produits du tabac effectuées au cours de la période du rapport;

b) soit sur les activités effectuées par le fabricant ou pour son compte au cours de la même période.

Reports under Part 3.1

(3) Despite subsection (1), the results of the tests referred to in subsection 14.2(6) must be submitted to the Minister in an electronic format that is acceptable to the Minister, based on the following criteria:

(a) the Minister must have access to the test results;

(b) the Minister must be able to electronically process the test results without having to re-copy or re-enter them; and

(c) the Minister must be able to clearly identify the test result data.

4. Section 4 of the Regulations is replaced by the following:

Accreditation

4. (1) Any laboratory that performs an analysis on which a manufacturer relies for the purposes of these Regulations shall be accredited under the International Organization for Standardization standard ISO/IEC 17025, first edition, dated December 15, 1999, entitled General Requirements for the Competence of Testing and Calibration Laboratories.

Scope of Accreditation

(2) The document entitled Scope of Accreditation issued by the Standards Council of Canada to the laboratory referred to in subsection (1) or any other equivalent document that is evidence of the laboratory's accreditation shall specify the method used to perform the analysis referred to in subsection (1).

5. The Regulations are amended by adding the following after section 14:

PART 3.1

Toxicity of Cigarette Emissions

Interpretation

Definitions

14.1 The following definitions apply in this Part.

"cigarette"
« cigarette »

"cigarette" means any roll or tubular construction that contains tobacco, has a wrapper or cover made of paper and is consumed through the inhalation of the products of combustion but does not include a bidi, cigar, kretek or tobacco stick.

"identical cigarettes"
« cigarettes identiques »

"identical cigarettes" means cigarettes that

(a) contain identical ingredients;

(b) are manufactured in an identical manner;

(c) have identical dimensions; and

(d) perform in an identical manner under the same conditions.

Toxicity Testing and Report Requirements

Initial testing

14.2 (1) Every manufacturer shall perform toxicity testing in accordance with subsection (6) on every brand of cigarettes that it manufactures after December 31, 2004 and before October 1, 2005.

Annual testing

(2) After September 30, 2005, for every period beginning on January 1 of a year and ending on December 31 of the same year, every manufacturer shall perform toxicity testing in accordance with subsection (6) on every brand of cigarettes that it manufactures during that period.

Report

(3) The manufacturer shall submit a report of the test results to the Minister on or before January 31 of the year following the year in which the tested cigarettes were manufactured.

Presentation of results

(4) The report shall include

(a) the date of manufacture of the cigarettes tested, the name of the testing laboratory, the start and end dates of the tests, the results of the tests and the name of the applicable Department of Health official method used for the tests;

(b) in the case of a report on the initial testing required by subsection (1), the results, if known, of the ignition propensity tests conducted on cigarettes of the same brand using ASTM International method E2187 -- 04, dated July 1, 2004 and entitled Standard Test Method for Measuring the Ignition Strength of Cigarettes; and

(c) a copy of all laboratory reports.

Number of replicates of a sample

(5) The results of the tests performed in accordance with paragraph (6)(a) or (b) shall be based on three replicates of a sample.

Method of collecting data

(6) The toxicity data shall be collected using the following test methodologies:

(a) Department of Health Official Method T-501, entitled Bacterial Reverse Mutation Assay for Mainstream Tobacco Smoke, as amended from time to time;

(b) Department of Health Official Method T-502, entitled Neutral Red Uptake Assay for Mainstream Tobacco Smoke, as amended from time to time; and

(c) Department of Health Official Method T-503, entitled In Vitro Micronucleus Assay for Mainstream Tobacco Smoke, as amended from time to time.

Sampling

(7) The sampling of cigarettes for the toxicity testing shall be performed 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 October 15, 1991 and entitled Cigarettes -- Sampling.

Conditioning

(8) The cigarettes to be used in the toxicity testing shall be conditioned in an environment as described in the International Organization for Standardization standard ISO 3402, fourth edition, dated December 15, 1999 and entitled Tobacco and Tobacco Products -- Atmosphere for Conditioning and Testing.

Exception -- identical cigarettes

(9) A manufacturer is not required to perform the testing and submit the report in respect of a particular brand of cigarettes if the manufacturer

(a) sells identical cigarettes under more than one brand, including the particular brand;

(b) submits a report under this section in respect of another of those brands of identical cigarettes and that brand is specified in the report as being the "reference brand"; and

(c) specifies in the report that is submitted in respect of the reference brand the other brands of identical cigarettes that are also covered by the report, including the particular brand.

Coming into force

6. These Regulations come into force on the day on which they are registered.

Disclaimer: This is not an official version of these regulations. For all purposes of interpreting and applying these regulations, consult the regulations as registered by the Clerk of the Privy Council and published in Part II of the Canada Gazette. These regulations are anticipated to be published in the June 29, 2005 issue of Canada Gazette Part II. For a copy of the registered version of the regulations, please contact the Privy Council Office, Orders in Council Division, Statutory Instruments, 4th Floor, 85 Sparks Street, Ottawa.