PROVINCE OF BRITISH COLUMBIA ORDER OF THE LIEUTENANT GOVERNOR IN COUNCIL

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1 PROVINCE OF BRITISH COLUMBIA ORDER OF THE LIEUTENANT GOVERNOR IN COUNCIL Order in Council No. ' 423, Approved and Ordered APR mork Lieutenant Governor Executive Council Chambers, Victoria On the recommendation of the undersigned, the Lieutenant Governor, by and with the advice and consent of the Executive Council, orders that B.C. Reg. 282/98, Tobacco Testing and Disclosure Regulation, is amended as set out in the attached Appendix. Minister of Health and Minister Responsible for Seniors Press g Member of the Executive Council (This part is for administrative purposes only and is not part of the Order.) Authority under which Order is made: Act and section:- Tobacco Sales Act, 11 (2) (h.2) Other (specify):- OIC 1107/98 March 27, ;9, /22

2 APPENDIX 1 Sections 1 to 6 of the Tobacco Testing and Disclosure Regulation, B.C. Reg. 282/98, are repealed and the following substituted: Definitions 1 In this regulation: "additive" means any substance, chemical or compound, other than tobacco, water or reconstituted tobacco sheet, that is introduced by a manufacturer into the tobacco, paper or filter of a cigarette or into cigarette tobacco during the processing, manufacturing or packing of the cigarette or cigarette tobacco; "brand" includes (a) any sub-brands of a brand, and (b) un-branded generic cigarettes; "cigarette" includes any roll or tubular construction that contains tobacco; "cigarette equivalent" means a cigarette prepared from leaf tobacco, fine cut tobacco or loose tobacco; "ingredient" means (a) tobacco, water or reconstituted tobacco sheet, and (b) any substance, chemical or compound, other than additives, in the paper or filter of a cigarette; "manufacturer" means a corporation that manufactures, fabricans, produces or packs cigarettes or cigarette tobacco for the personal use or consumption of consumers; "market share" for a calendar year means British Columbia market share as of December 31 of that calendar year for cigarettes based on the total units of cigarettes manufactured, fabricated, produced or packed in Canada and sold in British Columbia; "smoke constituents" means the constituents of mainstream smoke and sidestream smoke listed in Schedule A or E as applicable. Ingredient and additive reports 2 (1) Every manufacturer must submit an annual report to the minister which identifies and lists, by brand, all ingredients and additives in every brand of cigarette or cigarette tobacco of the manufacturer that is sold, offered for sale, distributed, advertised or promoted in British Columbia in a calendar year. (2) For each ingredient and additive, a report under subsection (1) must include all of the following, as applicable: (a) the common name and any common synonyms; 1 of 8

3 (b) the biological origin, in standard Latin nomenclature; (c) the chemical name and any chemical name synonyms; (d) the brand name; (e) the registry number assigned to the ingredient or additive in accordance with the Chemical Abstracts Service of the American Chemical Society; (f) the quantity of each ingredient or additive, expressed as a proportion of the total weight of a cigarette or cigarette equivalent. (3) A report under subsection (1) in respect of a calendar year must be received by the minister no later than December 31 of that year. (4) A report under subsection (1) must be in Form 1 of Schedule B. (5) A report under this regulation must, for each brand included in the report, (a) indicate the legal name of the manufacturer, (b) for new brands, indicate the date when the brand was introduced in British Columbia, (c) be a report on the brand as sold, offered for sale, distributed, advertised or promoted in British Columbia in the calendar year for which the report is filed, and (d) identify the brand or sub-brand by name and by a unique identification number. (6) A report under subsection (1) must, for each brand included in the report, indicate (a) the average total weight of a cigarette of that brand, or (b) the average total weight of tobacco in each cigarette equivalent. Reporting proportion of ingredient or additive 2.1 (1) Every report made under section 2 (1) must include, for the information of the minister but not for public release, the quantity of each ingredient or additive, expressed as a proportion of the total weight of a cigarette or cigarette equivalent. (2) Section 2 (3), as it was on May 19, 2000, applies to the information to be reported under subsection (1) of this section. (3) This section applies only to reports for 1998, 1999 and Change reports to be submitted 2.2 (1) Despite section 2.1, if there is a change in the presence of or change in the quanity of an ingredient or additive in a brand for any reason, the manufacturer must, not later than 90 days after the change, submit a change report in Form 1 of Schedule B and identify it as such by the use of the title "Change Report", and indicate in the report the date of the change. (2) Section 2.3 applies to a report under subsection (1). Trade secrecy claims 2.3 (1) If a brand of cigarette or cigarette tobacco contains an ingredient or additive, the quantity or presence of which the manufacturer claims is a trade secret, a repots under section 2 (1) may contain 2 parts: page 2 of 8

4 (b) the biological origin, in standard Latin nomenclature; (c) the chemical name and any chemical name synonyms; (d) the brand name; (e) the registry number assigned to the ingredient or additive in accordance with the Chemical Abstracts Service of the American Chemical Society; (f) the quantity of each ingredient or additive, expressed as a proportion of the total weight of a cigarette or cigarette equivalent. (3) A report under subsection (1) in respect of a calendar year must be received by the minister no later than December 31 of the following calendar year. (4) A report under subsection (1) must be in Form 1 of Schedule B. (5) A report under this regulation must, for each brand included in the report, (a) indicate the legal name of the manufacturer, (b) for new brands, indicate the date when the brand was introduced in British Columbia, (c) be a report on the brand as sold, offered for sale, distributed, advertised or promoted in British Columbia in the calendar year for which the report is filed, and (d) identify the brand or sub-brand by name and by a unique identification number. (6) A report under subsection (1) must, for each brand included in the report, indicate (a) the average total weight of a cigarette of that brand, or (b) the average total weight of tobacco in each cigarette equivalent. Reporting proportion of ingredient or additive 2.1 (1) Every report made under section 2 (1) must include, for the information of the minister but not for public release, the quantity of each ingredient or additive, expressed as a proportion of the total weight of a cigarette or cigarette equivalent. (2) Section 2 (3), as it was on May 19, 2000, applies to the information to be reported under subsection (1) of this section. (3) This section applies only to reports for 1998, 1999 and Change reports to be submitted 2.2 (1) Despite section 2.1, if there is a change in the presence of or change in the quanity of an ingredient or additive in a brand for any reason, the manufacturer must, not later than 90 days after the change, submit a change report in Form 1 of Schedule B and identify it as such by the use of the title "Change Report", and indicate in the report the date of the change. (2) Section 2.3 applies to a report under subsection (1). Trade secrecy claims 2.3 (1) If a brand of cigarette or cigarette tobacco contains an ingredient or additive, the quantity or presence of which the manufacturer claims is a trade secret, a report under section 2 (1) may contain 2 parts: page 2 of 8

5 (a) a public report in Form 1 of Schedule B, identified as such by the use of the title "Public Report", for public release by the minister; (b) a trade secrets report in Form 1 of Schedule B, identified as such by the use of the title "Trade Secrets Report", intended for the information of the minister but not for public release. (2) A public report under subsection (1) must contain (a) the information required under section 2 (2) for all ingredients and additives, the quantity and presence of which the manufacturer does not claim are trade secrets, (b) information required under section 2 (2) (a) to (e) for all ingredients and additives, the quantity but not the presence of which the manufacturer claims is a trade secret, and (c) the information required under section 2 (2) (f) for all ingredients and additives, the presence but not the quantity of which the manufacturer claims is a trade secret. (3) A trade secrets report under subsection (1) must contain (a) all the information contained in the public report under subsection (1), (b) the information required under section 2 (2) (a) to (e) for all ingredients and additives, the presence but not the quantity of which the manufacturer Cairns is a trade secret, (c) the information required under section 2 (2) (f) for all ingredients and additives, the quantity but not the presence of which the manufacturer claims is a trade secret, (d) the information required under section 2 (2) for all ingredients and additives, the quantity and presence of which the manufacturer claims are trade secrets, and (e) an appendix, to be identified as the "Designation", which itemizes all omissions of quantity or presence from the public report and states in full, for each item, the grounds for the claim of trade secrecy. (4) Despite subsections (1) to (3), a manufacturer may not claim trade secrecy in respect of the presence of any ingredient or additive in a brand of cigarette or cigarette tobacco, the presence of which has been disclosed to the minister in a report submitted by the manufacturer to the minister on or before May 19, Smoke constituent reports 3 (1) Every manufacturer must submit an annual report to the minister that identifies and lists all of the following, by brand, for every brand of cigarette of the manufacturer that is sold, offered for sale, distributed, advertised or promoted in British Columbia in a calendar year: (a) yields for all smoke constituents listed in Schedule A and Schedule E as applicable; (b) the ph of mainstream tobacco smoke; (c) filter efficiency. (2) All testing and analyzing for the purposes of a report under subsection (1) for each smoke constituent listed in Schedule A or E, as applicable, must be carried page 3 of 8

6 out in accordance with the test method for that smoke constitutent as indicated in Schedule A or E and set out in detail in Schedule C. (2.1) Despite subsection (2), any testing and analyzing for the purposes of a report under subsection (1) may be carried out in accordance with a test method that differs from the one required under subsection (2) if (a) the use of the different test method results in information that is at least as accurate and precise as the information that would be produced if the test method required under subsection (2) were used, and (b) the manufacturer submits with the report of analysis under subsection (6) (i) a description of the different test method, and (ii) data that demonstrate that the rec,-..irements in paragraph (a) have been met. (3) Yields for each smoke constituent must be determined under each of the following smoking conditions: (a) International Organization for Standardization standard ISO 3308: 1991 entitled Routine analytical cigarette-smoking machine definition of standard conditions; (b) International Organization for Standardization standard ISO 3308: 1991 entitled Routine analytical cigarette-smoking machine definition of standard conditions, modified as follows: (1) puff volume must be increased from 35 millilitres to 55 millilitres; (ii) puff interval must be decreased from 60 seconds to 30 seconds; (iii) puff duration must remain at 2 seconds; (iv) 100% of the ventilation holes must be blocked by placing over them a strip of mylar adhesive tape, Scotch Brand product no. 600 Transparent Tape (Acetate) or other equivalent method, and the tape must be cut so that it covers 100% of the circumference and is tightly secured from the end of the filter to the tipping overwrap seam. (4) A report under subsection (1) in respect of a calendar year must be received by the minister no later than (a) April 30 of the following calendar year, for all brands of cigarettes with a market share equal to or greater than 2.00%, (b) July 31 of the following calendar year, for all other brands of cigarettes. (5) A report under subsection (1) must be in Form 2 of Schedule B. (6) A manufacturer must submit with each report under subsection (1) a separate report of analysis that does all of the following: (a) identifies and lists, by brand and for each smoke constituent yield, the mean, standard deviation, upper and lower 95% confidence limits and coefficient of variation, all of which must he based on at least (i) 20 observations of a sample, if the smoke constituent is tar, nicotine or carbon monoxide in mainstream smoke, (ii) 7 observations of a sample, if the smoke constituent is tar, nicotine or carbon monoxide in sidestream smoke, and page 4 of 8

7 (iii) 7 observations of a sample for all other smoke constituents in mainstream smoke and sidestream smoke; (b) identifies and lists, by brand, the limits of quantitation and detection for each smoke constituent; (c) sets out the criteria used for evaluation of the acceptability of the data and the evidence of acceptability; (d) sets out the criteria used for the detection and treatment of outliers as defined in section 2.64 of the International Organization for Standardization standard ISO :1993 (E/F) entitled Statistics Vocabulary and Symbols; (e) identifies and lists the yields for all smoke constituents in Schedules A and E, as applicable, the ph of mainstream tobacco smoke and the filter efficiency for each of the following, to be tested concurrently with the brands included in the report under subsection (1): (i) at least one Canadian monitor cigarette; (ii) at least one Kentucky Reference IR4F cigarette; (0 includes any other information necessary to meet the requirements for reporting test results to clients as set out in section 5.10 of the International Organization for Standardization draft standard ISO/IEC FDIS 17025:1999 (E) entitled, General requirements for the competence of testing and calibration laboratories. (7) In respect of a calendar year, this section does not apply to a brand of cigarette if its market share for the calendar year is less than 1.25%. Instructions for dating and paginating reports and electronic versions 3.1 A report under this regulation (a) must indicate the date of preparation of the report on each page of the report, (b) must indicate at the foot of each page the page number and the number of pages in the report as follows: "Page... of... pages", and (c) must be accompanied by an electronic copy of the information in the report, and that electronic copy must be in a comma-delimited, non-encrypted format. Public release of information in reports under section 2 or 3 4 Except for the information submitted in accordance with section 2.1 or contained in a trade secrets report submitted in accordance with section 2.3, the minister must release the information contained in a report under section 2 or 3 to the public in a manner that facilitates public access to the information. New brands 5 Despite section 2 (3), a manufacturer must not sell, offer for sale, distribute, advertise or promote any brand of cigarette or cigarette tobacco in British Columbia which was not sold, distributed, advertised or promoted in British Columbia before July 31, 1998, unless the minister has received a report under section 2 in respect of that brand of cigarette or cigarette tobacco. page 5 of 8

8 Reporting of sales volumes of cigarettes 6 (1) In this section, "unit" for cigarettes means a single cigarette. (2) A manufacturer must report the total number of units for every brand of cigarette of the manufacturer that is sold in British Columbia in a calendar year by January 31 of the following year. 2 Schedule A is repealed and the following substituted: 1 ammonia (Official Method T-101) SCHEDULE A MAINSTREAM SMOKE 2 1-aminonapthalene, 2-aminonapthalene, 3-aminobiphenyl and 4-aminobiphenyl (Official Method T-102) 3 benzo[a]pyrene (Official Method T-103) 4 formaldehyde, acetaldehyde, acetone, acrolein, propionaldehyde, crotonaldehyde, methyl ethyl ketone and butyraldehyde (Official Method T-104) 5 hydrogen cyanide (Official Method T-107) 6 mercury (Official Method T-108) 7 nickel, lead, cadmium, chromium, arsenic and selenium (Official Method T-109) 8 nitric oxide (Official Method T-I10) 9 N-nitrosonornicotine (NNN), 4-(N-nitrosomethylamino)-1-(3-pyridy1)-1-butanone (NNK), N-nitrosoanatabine (NAT) and N-nitrosoanabasine (NAB) (Official Method T-111) 10 pyridine, quinoline and styrene (Official Method T-112) 11 hydroquinone, resorcinol, catechol, phenol, m+p-cresol, and o-cresol (Official Method T-I 14) 12 tar, nicotine and carbon monoxide (Official Method T-115) 13 1,3-butadiene, isoprene, acrylonitrile, benzene and toluene (Official Method T-116) 1 ammonia (Official Method T-201) SIDESTREAM SMOKE 2 1-aminonapthalene, 2-aminonapthalene, 3-aminobiphenyl and 4-aminobiphenyl (Official Method T-202) 3 benzo[a]pyrene (Official Method T-203) 4 formaldehyde, acetaldehyde, acetone, acrolein, propionaldehyde, crotonaldehyde, methyl ethyl ketone and butyraldehyde (Official Method T-204) 5 hydrogen cyanide (Official Method T-205) 6 mercury (Official Method T-206) 7 nickel, lead, cadmium, chromium, arsenic and selenium (Official Method T-207) 8 nitric oxide (Official Method T-208) 9 N-nitrosonornicotine (NNN), 4-(N-nitrosomethylamino)-1-(3-pyridy1)-1-butanone (NNK), N-nitrosoanatabine (NAT) and N-nitrosoanabasine (NAB) (Official Method T-209) 10 pyridine and quinoline (Official Method T-210) 11 hydroquinone, resorcinol, catechol, phenol, m+p-cresol and o-cresol (Official Method T-211) 12 tar and nicotine (Official Method T-212) 13 1,3-butadiene, isoprene, acrylonitrile, benzene, toluene and styrene (Official Method T-213) page 6 of 8

9 14 carbon monoxide (Official Method T-214) 3 Schedule B is amended (a) by striking out everything after "Form 1: Ingredient and Additive Reporting Form" and before "Use additional forms if required" and substituting the following: [Indicate: Public Report, Trade Secrets Report or Change Report, as applicable] Brand Name Sub-Brand:. Unique identification number: Manufacturer name: Reporting year: Date of preparation of report: Average total weight: (b) by adding the following before the heading for Form 2: Designation [for use in Trade Secrets Reports only] (c) by striking out everything after "Form 2: Smoke Constituent Reporting Form" and before "ammonia" in the table in Form 2 and substituting the following: Brand Name. Sub-Brand: Unique identification number: Manufacturer name: Reporting year: Date of preparation of report: Mainstream Smoke Sidestrearn Smoke Unit Standard ISO Modified ISO* Standard ISO Modified ISO' (d) by adding the following in Form 2 after the table: [* "Modified ISO" refers to the ISO standard as modified under section 3 (3) (b) of this regulation]..1 Schedule D is repealed. 5 The following schedule is added: page 7 of 8

10 I SCHEDULE E SIDESTREAM SMOKE (*MODIFIED ISO) CONSTITUENTS 2-aminonapthalene and 4-aminobiphenyl (Official Method T-202) 2 benzo[a]pyrene (Official Method T-203) 3 nickel, lead and cadmium (Official Method T-207) 4 formaldehyde, acetaldehyde and methyl ethyl ketone (Official Method T-204) 5 N-nitrosonomicotine (NNN), 4-(N-nitrosomethylamino)-1-(3-pyridyI)-1-butanone (NNK), N-nitrosoanatabine (NAT) and N-nitrosoanabasine (NAB) (Official Method T-209) [* "Modified ISO" refers to the ISO standard as modified under section 3 (3) (b) of this regulation]. page 8 of 8

11 SCHEDULE E SIDESTREAM SMOKE (*MODIFIED ISO) CONSTITUENTS 1 2-aminonapthalene and 4-aminobiphenyl (Official Method T-202) 2 benzo[a]pyrene (Official Method 1-203) 3 nickel, lead and cadmium (Official Method T-20'7) 4 formaldehyde, acetaldehyde and methyl ethyl ketone (Official Method T-204) 5 N-nitrosonornicotine (NNN), 4-(N-nitrosomethylamino)-1-(3-pyridy1)-1-butanone (NNK), N-nitrosoanatabine (NAT) and N-nitrosoanabasine (NAB) (Official Method T-209). 1* "Modified ISO" refers to the ISO standard as modified under section 3 (3) (b) of this regulation].