Regulations Amending Certain Department of Health Regulations (Miscellaneous Program): SOR/2022-197

Canada Gazette, Part II, Volume 156, Number 21

Registration
SOR/2022-197 September 27, 2022

FOOD AND DRUGS ACT
RADIATION EMITTING DEVICES ACT
DEPARTMENT OF HEALTH ACT
ASSISTED HUMAN REPRODUCTION ACT
CANADA CONSUMER PRODUCT SAFETY ACT
CANNABIS ACT

P.C. 2022-1010 September 23, 2022

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Department of Health Regulations (Miscellaneous Program), pursuant to

(a) subsection 30(1)^{footnote a} of the Food and Drugs Act ^{footnote b};
(b) subsection 13(1)^{footnote c} of the Radiation Emitting Devices Act ^{footnote d};
(c) subsection 11(1) of the Department of Health Act ^{footnote e}
(d) subsection 65(1)^{footnote f} of the Assisted Human Reproduction Act ^{footnote g}
(e) subsection 37(1)^{footnote h} of the Canada Consumer Product Safety Act ^{footnote i}; and
(f) subsection 139(1) of the Cannabis Act ^{footnote j}.

Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)

Food and Drugs Act

Food and Drug Regulations

1 The definition common-law partner in section A.01.010 of the Food and Drug Regulations ^{footnote 1} is replaced by the following:

common-law partner: has the same meaning as in section 2 of the Criminal Code. (conjoint de fait)

2 Section A.01.025 of the Regulations is replaced by the following:

A.01.025 If authorized by a regulation made pursuant to the Broadcasting Act, inspectors shall act as representatives of the Canadian Radio-television and Telecommunications Commission for the purpose of enforcing the provisions of regulations made by the Canadian Radio-Television and Telecommunications Commission concerning the advertising of any article to which the Food and Drugs Act applies, or concerning recommendations for the prevention, treatment or cure of a disease or ailment.

3 (1) Subparagraph B.01.008.2(1)(a)(i) of the English version of the Regulations is replaced by the following:

(i) “Ingredients”, “Ingredients:” or “Ingredients :” in the English version of the list, and

(2) Subparagraph B.001.008.2(1)(a)(ii) of the French version of the Regulations is replaced by the following:

(ii) « Ingredients », « Ingredients : » ou « Ingredients : » pour ce qui est de la version anglaise de la liste;

4 Subsection B.01.008.3(4) of the Regulations is amended by striking out “and” at the end of paragraph (d), by adding “and” at the end of paragraph (e) and by adding the following after paragraph (e):

(f) prepackaged products that contain less than 0.5 g of sugars per serving of stated size.

5 The table to section B.24.102 of the English version of the Regulations is amended by replacing “microgram” and “micrograms” with “µg”, “milligram” and “milligrams” with “mg”, and “International Units” with “I.U.”.

6 (1) The portion of paragraph B.24.103(d) before subparagraph (i) of the Regulations is replaced by the following:

(d) a statement of the content of vitamins and mineral nutrients that are listed in the table to section B.24.102, expressed in International Units, milligrams or micrograms

(2) The portion of paragraph B.24.103(e) before subparagraph (i) of the Regulations is replaced by the following:

(e) a statement of the content of any vitamin or mineral nutrient that is not listed in the table to section B.24.102, expressed in milligrams or micrograms

7 Table II to Division 25 of Part B of the Regulations in column II is amended by replacing “mcg” with “µg”.

8 (1) The definition List C in subsection C.01.001(1) of the English version of the Regulations is replaced by the following:

List C: means the document, entitled List of Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; (Liste C)

(2) The definition Liste D in subsection C.01.001(1) of the French version of the Regulations is replaced by the following:

Liste D: Document intitulé Liste de certaines drogues sans ordonnance pouvant être distribuées à titre d’échantillons, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (List D)

9 The portion of subsection C.08.015(1) of the Regulations before paragraph (a) is replaced by the following:

C.08.015 (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Minister has determined that

10 (1) Subsection C.10.002(1) of the Regulations is replaced by the following:

C.10.002 (1) A sale of a drug that is imported under subsection C.10.001(2) is exempt from the provisions of these Regulations only if the drug is sold to a person within the jurisdiction of a public health official who has notified the Minister as described in paragraph C.10.001(2)(a), for use in respect of the same urgent public health need for which it was imported.

(2) Subsection C.10.002(2) of the Regulations is amended by adding the following after paragraph (d):

(d.1) section C.02.014;

(3) Subsection C.10.002(2) of the Regulations is amended by adding the following after paragraph (f):

(f.1) subsection C.02.021(1), in respect of storage;

11 Paragraph D.01.003(1)(j) of the Regulations is replaced by the following:

(j) in the case of folate, in terms of the content of folic acid (pteroylmonoglutamic acid) and related compounds exhibiting the biological activity of folic acid, calculated on the basis of micrograms of dietary folate equivalents (DFE) and expressed in micrograms on the basis of the following relationships:
- (i) 1 DFE = 1 μg food folate, and
- (ii) 1 DFE = 0.6 μg folic acid from food with added folic acid;

Medical Devices Regulations

12 Subparagraph 10(c)(ii) of the French version of the Medical Devices Regulations ^{footnote 2} is replaced by the following:

(ii) prévoir les mesures de protection indiquées contre ces risques, en incluant notamment des fonctions d’alarme,

13 Paragraph 3(d) in Schedule 2 of the French version of the Regulations is replaced by the following:

(d) système d’assistance ventriculaire implantable;

Safety of Human Cells, Tissues and Organs for Transplantation Regulations

14 Section 37 of the English version of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations ^{footnote 3} is replaced by the following:

37 An establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions and adequate packaging materials.

Cannabis Act

Cannabis Regulations

15 (1) The definition fresh cannabis in subsection 1(1) of the Cannabis Regulations ^{footnote 4} is replaced by the following:

fresh cannabis: means freshly harvested cannabis leaves, flowers or buds, but does not include plant material that can be used to propagate cannabis. (cannabis frais)

(2) The definitions potentiel de transformation de l’ACBD en CBD and potentiel de transformation de l’ATHC en THC in subsection 1(2) of the French version of the Regulations are replaced by the following:

potentiel de transformation de l’ACBD en CBD: Quantité maximale de CBD qui serait obtenue si l’ACBD était transformé en CBD, sans détérioration additionnelle de celui-ci. (potential to convert CBDA into CBD)
potentiel de transformation de l’ATHC en THC: Quantité maximale de THC qui serait obtenue si le ATHC était transformé en THC, sans détérioration additionnelle de celui-ci. (potential to convert THCA into THC)

Regulations Amending the Cannabis Regulations (New Classes of Cannabis)

16 Section 73 of the Regulations Amending the Cannabis Regulations (New Classes of Cannabis) ^{footnote 5} are repealed.

17 Section 75 of the Regulations is repealed.

18 (1) Subsections 76(1) and (2) of the Regulations are repealed.

(2) Subsection 76(4) of the Regulations is repealed.

19 (1) Subsections 77(1) and (2) of the Regulations are repealed.

(2) Subsection 77(4) of the Regulations is repealed.

20 (1) Subsections 78(1) and (2) of the Regulations are repealed.

(2) Subsection 78(4) of the Regulations is repealed.

21 (1) Subsections 79(1) and (2) of the Regulations are repealed.

(2) Subsection 79(4) of the Regulations is repealed.

22 (1) Subsections 80(1) and (2) of the Regulations are repealed.

(2) Subsection 80(4) of the Regulations is repealed.

Radiation Emitting Devices Act

Radiation Emitting Devices Regulations

23 The long title of the Radiation Emitting Devices Regulations ^{footnote 6} is replaced by the following:

Radiation Emitting Devices Regulations

24 Section 1 of the Regulations and the heading before it are repealed.

25 (1) Subparagraph 35(1)(b)(i) of Part II of Schedule II of the French version of the Regulations is replaced by the following:

(i) dans le cas d’un appareil portatif, 1,5 µGy/h,

(2) Paragraph 2(3)(a) of Part IV of Schedule II of the English version of the Regulations is replaced by the following:

(a) doors or panels over all access openings that are designed for insertion or removal of baggage, unless the device is designed to prevent the insertion of any part of the human body into the primary X-ray beam through those access openings;

Assisted Human Reproduction Act

Safety of Sperm and Ova Regulations

26 Paragraph 16(1)(a) of the English version of the Safety of Sperm and Ova Regulations ^{footnote 7} is replaced by the following:

(a) the primary establishment has not provided the annual attestation that is required under section 20;

Canada Consumer Product Safety Act

Consumer Chemicals and Containers Regulations, 2001

27 (1) Item 7 of the table to subsection 1(2) of the Consumer Chemicals and Containers Regulations, 2001 ^{footnote 8} in column 2 is amended by replacing “CSA Standard B306-M1977(R2013)” with “CSA Standard B306-M1977 (R2018)”.

(2) Item 9 of the table to subsection 1(2) of the Regulations in column 2 is amended by replacing “CSA Standard B376-M1980(R2014)” with “CSA Standard B376-M1980 (R2019)”.

(3) Item 18 of the table to subsection 1(2) of the Regulations in column 2 is amended by replacing “CAN/ULC-S503-05(R2010)” with “CAN/ULC Standard S503-05-R2018”.

(4) Item 19 of the table to subsection 1(2) of the Regulations in column 2 is amended by replacing “CAN/ULC-S504-12” with “CAN/ULC Standard S504-12-R2018”.

(5) Item 20 of the table to Subsection 1(2) of the Regulations in column 2 is amended by replacing “CAN/ULC-S507-05(R2010)” with “CAN/ULC Standard S507-05-R2018”.

Department of Health Act

Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations

28 Section 5 of the Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations ^{footnote 9} is replaced by the following

5 Water that is provided by way of a potable water system or from a potable water container must not exceed the maximum acceptable concentration for Escherichia coli (E. coli) of none detectable per 100 mL.

Coming into Force

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

On September 18, 2018, the Standing Joint Committee for the Scrutiny of Regulations identified a technical issue with subsection C.08.015(1) of the Food and Drug Regulations that Health Canada committed to address through the Miscellaneous Amendments process.

The need for a number of minor technical amendments to the Consumer Chemicals and Containers Regulations, 2001, the Food and Drug Regulations, the Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations, the Medical Devices Regulations, the Cannabis Regulations, the Regulations Amending the Cannabis Regulations (New Classes of Cannabis), the Radiation Emitting Devices Regulations, the Safety of Sperm and Ova Regulations, and the Safety of Human Cells, Tissues and Organs for Transplantation Regulations was also identified through departmental review processes completed as part of Health Canada’s good regulatory stewardship practices.

Objective

The amendments have the following objectives:

to correct discrepancies between the French and English versions;
to add clarity to a regulatory provision;
to harmonize terms used in the regulations with those used in the enabling statute or related regulations;
to correct typographical or grammatical errors;
to repeal obsolete or spent regulatory provisions that have no current application; and
to update references to standards and other incorporation-by-reference documents.

Description and rationale

1. Correcting discrepancies between the French and English versions

Amendments to the following regulations correct discrepancies between the French and English versions of the regulations to improve clarity and reduce the risk of inconsistent interpretation:

Food and Drug Regulations

The French version of section A.01.025 of the Food and Drug Regulations is amended to replace the term “agents” with the term “représentants.” The amendment provides alignment with the intended meaning of the term “representatives” that is captured in the English version so as to include all types of representation.

The English version of subparagraph B.01.008.2(1)(a)(i) of the Food and Drug Regulations and the French version of subparagraph B.01.008.2(1)(a)(ii) are amended to provide the option to either use or not use the space in both the English and French versions of these subparagraphs (e.g. “Ingredients:” or “Ingredients :”).

The French version of the definition of “Liste D” in subsection C.01.001(1) of the Food and Drug Regulations is changed from “certains” to “certaines” and the word “vendues” is removed in the title “Liste de certains drogues vendues sans ordonnance pouvant être distribuées à titre d’échantillons.” The amendment corrects a typographical and translation error in the name of the list in the French version of the Regulations.

Medical Devices Regulations

The French version of subparagraph 10(c)(ii) of the Medical Devices Regulations is amended to align with the English version by replacing “notamment des dispositifs d’alarme” with “en incluant notamment des fonctions d’alarme.”

The French version of Schedule 2 (Section 1), paragraph 3(d) of the Medical Devices Regulations is amended to align with the English version by replacing “dispositif d’assistance ventriculaire implantable” with “système d’assistance ventriculaire implantable;”.

Cannabis Regulations

The definitions of “potentiel de transformation de l’ACBD en CBD” and “potentiel de transformation de l’ATHC en THC” in subsection 1(2) of the French version of the Cannabis Regulations are amended to replace “sans que celui-ci ne se détériore davantage” with “sans détérioration additionnelle de celui-ci.” This improves alignment between the French and English versions of the subsection given that the English version reads “with no further degradation of CBD” and “with no further degradation of THC,” respectively.

Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Section 37 of the English version of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations is amended to improve alignment between the English and French versions of this provision as it relates to packaging. The words “and adequate packaging materials” are being added in the English version to align with the French version of the regulations. The English version is amended to “An establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions and adequate packaging materials.”

Safety of Sperm and Ova Regulations

The word “statement” in paragraph 16(1)(a) in the English version of the Safety of Sperm and Ova Regulations is replaced by the word “attestation.” This improves alignment of the English and French versions of the paragraph. The French version uses the term “attestation.”

2. Add clarity to a regulatory provision

Amendments to the following regulations improve clarity for various provisions to facilitate consistent interpretation of the regulations:

Food and Drug Regulations

Subsection B.01.008.3(4) of the Food and Drug Regulations is amended to allow a sugars-grouping exemption for certain prepacked products. This provides consumers with consistent information about the sugars content in the list of ingredients and the Nutrition Facts Table.

Paragraphs B.24.103(d) and (e) of the Food and Drug Regulations are amended to allow micronutrient content for Formulated Liquid Diets to be declared in International Units, milligrams or micrograms. This amendment clarifies the provisions to facilitate compliance verification and improve consistency within the Regulations.

Subsection C.08.015(1) of the Food and Drug Regulations is amended to replace the words “is satisfied” / “est convaincu” with “has determined” / “a conclu.” The amendment improves clarity by removing an unnecessary element of subjectivity from the subsection, an issue raised by the Standing Joint Committee for the Scrutiny of Regulations.

Subsection C.10.002(1) of the Food and Drug Regulations is amended to clarify the circumstances under which the sale of the drug that is imported in accordance with Part C, Division 10 (Access to Drugs in Exceptional Circumstances) is exempt from the provisions of the Regulations. Adding the leading text “to a person” in the existing sentence “within the jurisdiction of a public health official who has notified the Minister” better captures the original intent of this provision. The amendment reflects that the importer or wholesaler may be located anywhere in Canada and does not have to be located within the same jurisdiction as the public health official who notified the Minister.

Subsection C.10.002(2) of the Food and Drug Regulations is amended to include reference to quality control (section C.02.014) and record keeping (subsection C.02.021(1)) requirements. The amendment clarifies that, despite the exemption provided for in this subsection, these good manufacturing practices apply to wholesalers who sell a drug in accordance with Part C, Division 10 (Access to Drugs in Exceptional Circumstances). The application of these sections aligns with other schemes under the Food and Drug Regulations that allow the importation and sale of a drug under exceptional circumstances.

Paragraph D.01.003(1)(j) is amended to provide clarity to the conversion factors of folate. The conversion factors used are those used by the Institute of Medicine (National Academy of Medicine), reflecting current science.

Radiation Emitting Devices Regulations

The long title of the Radiation Emitting Devices Regulations is replaced by the short title of the Regulations and the short title provision is repealed. The amendment improves the readability of the Regulations by removing any distinction between the long and short title.

3. Harmonizing terms used in the regulations with those used in the enabling statute or related regulations

Amendments to the following regulations harmonize terms with those used in the enabling statute and/or related regulations to improve alignment and clarity:

Cannabis Regulations

The definition of “fresh cannabis” in subsection 1(1) of the Cannabis Regulations is amended to include the term “flowers” in addition to “buds” to align with how “budding or flowering” is used in the Cannabis Act. The amended definition will be “fresh cannabis means freshly harvested cannabis leaves, flowers or buds, but does not include plant material that can be used to propagate cannabis (cannabis frais).”

Food and Drug Regulations

The definition for “common-law partner” under section A.01.010 of the Food and Drug Regulations is replaced by a reference to the definition for “common law partner” found in the Criminal Code. This amendment has the effect of adopting the definition set out in the Criminal Code.

The abbreviations of units of measure for micronutrients in the English version of the Table to section B.24.102 of Division 24 and Table II in Division 25 of Part B in column II are amended to align with other abbreviations in the Food and Drug Regulations, as necessary, by

(a) replacing “microgram” and “micrograms” with “µg”;
(b) replacing “milligram” and “milligrams” with “mg”; and
(c) replacing “International Units” with “I.U.”.

4. Correcting typographical or grammatical errors

Amendments to the following regulations correct typographical or grammatical errors to improve readability of the affected regulations:

Food and Drug Regulations

The English version of the definition of “List C” in subsection C.01.001(1) of the Food and Drug Regulations is amended to add “List of” at the beginning of the document title. This amendment improves alignment of the English and French versions of this subparagraph.

Radiation Emitting Devices Regulations

Schedule II, Part II (Dental X-Ray Equipment), subparagraph 35(1)(b)(i) in the French version of the Radiation Emitting Devices Regulations is amended by replacing “1,25 µGy/h” with “1,5 µGy/h” to correct this typographical error. The typographical error is not present in the English version of the subparagraph.

Schedule II, Part IV (Baggage Inspection X-ray Devices), paragraph 2(3)(a) in the English version of the Radiation Emitting Devices Regulations is amended by replacing the word “devise” with “device” to correct this typographical error.

5. Repealing obsolete or spent regulatory provisions that have no current application

Amendments to the following regulations repeal obsolete or spent regulatory provisions that have no current application:

Food and Drug Regulations

The outdated reference to the “Proprietary or Patent Medicine Act” under section A.01.025 of the Food and Drug Regulations is repealed as that Act is no longer in force.

Regulations Amending the Cannabis Regulations (New Classes of Cannabis)

The following transitional provisions in the Regulations Amending the Cannabis Regulations (New Classes of Cannabis) are repealed as they have ceased to have effect:

Section 73 and its subsections 73(1), 73(2), 73(3) and 73(4);
Section 75 and its subsections 75(1) and 75(2);
Subsections 76(1), 76(2) and 76(4);
Subsections 77(1), 77(2) and 77(4);
Subsections 78(1), 78(2) and 78(4);
Subsections 79(1), 79(2) and 79(4); and
Subsections 80(1), 80(2) and 80(4).

6. Updating references to standards and other incorporation-by-reference documents

Amendments to the following regulations update references to standards and other incorporation-by-reference documents:

Consumer Chemicals and Containers Regulations, 2001

The following standards referenced in the Consumer Chemicals and Containers Regulations, 2001 have been reaffirmed (i.e. a new version of the standard has been published without substantive technical changes) and the Regulations are updated to reflect the latest reaffirmed dates:

Item 7 — Revise “CSA Standard B306-M1977(R2013),” entitled Portable Fuel Tanks for Marine Use, as amended April 1988 to “CSA Standard B306-M1977 (R2018),” entitled Portable Fuel Tanks for Marine Use, as amended April 1988;
Item 9 — Revise “CSA Standard B376-M1980(R2014),” entitled Portable Containers for Gasoline and Other Petroleum Fuels, published July 1980 in the English version and June 1986 in the French version to “CSA Standard B376-M1980 (R2019),” entitled Portable Containers for Gasoline and Other Petroleum Fuels, published July 1980 in the English version and June 1986 in the French version;
Item 18 — Revise “CAN/ULC-S503-05(R2010),” Fourth Edition, entitled Carbon-Dioxide Fire Extinguishers, published February 28, 2005, to “CAN/ULC Standard S503-05-R2018,” Fourth Edition, entitled Carbon-Dioxide Fire Extinguishers, published February 28, 2005;
Item 19 — Revise “CAN/ULC-S504-12,” Third Edition, entitled Dry Chemical Fire Extinguishers, published August 14, 2002, to “CAN/ULC Standard S504-12-R2018,” Third Edition, entitled Dry Chemical Fire Extinguishers, published August 14, 2002; and,
Item 20 — Revise “CAN/ULC-S507-05(R2010),” Fourth Edition, entitled Water Fire Extinguishers, published February 28, 2005, to “CAN/ULC Standard S507-05-R2018,” Fourth Edition, entitled Water Fire Extinguishers, published February 28, 2005.

Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations

Section 5 of the Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations is amended to remove reference to the Maximum Acceptable Concentration (MAC) of Escherichia coli (E. Coli) in the Guidelines for Canadian Drinking Water Quality, and include the MAC directly into the Regulation.

One-for-one rule and small business lens

The one-for-one rule does not apply to these amendments, as there is no change in administrative costs or burden to business.

Analysis under the small business lens also determined that the proposal will not impact small businesses in Canada.

Contact

Catherine Hudon
Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Address locator: 1907A
200 Eglantine Driveway
Jeanne Mance Building, Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 343‑540‑8524
Email: hc.dra-arm.sc@hc-sc.gc.ca