Canada Gazette, Part I, Volume 155, Number 12: GOVERNMENT NOTICES

March 20, 2021

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 20521

Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health have assessed information in their possession in respect of the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4- trimethyl-1,3-pentanediol mono(2-methylpropanoate), Chemical Abstracts Service Registry Number 1661012-65-2, under section 83 of the Canadian Environmental Protection Act, 1999;

Whereas the substance is not specified on the Domestic Substances List;

And whereas the ministers suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Act,

Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that act applies with respect to the substance in accordance with the Annex.

The Honourable Jonathan Wilkinson
Minister of the Environment

ANNEX

Information Requirements
(Section 85 of the Canadian Environmental Protection Act, 1999)

1. The following definition applies in this notice:

“substance” means 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate), Chemical Abstracts Service Registry Number 1661012-65-2.

2. In relation to the substance, a significant new activity is

3. Despite section 2, a use of the substance is not a significant new activity if the substance is used

4. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 90 days before the day on which the activity begins:

5. The tests referred to in paragraphs 4(g), (h) and (i) must be conducted in accordance with the Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, that are current at the time the test is conducted.

6. The information in item 4 will be assessed within 90 days after the day on which it is received by the Minister of the Environment.

Transitional provisions

7. Despite section 2, in the period between the date of publication of the present notice and March 20, 2022, a significant new activity is

8. For greater certainty, in respect of calendar year 2022, the quantity of substance that is used before March 21 of that calendar year is not considered for the purposes of section 2.

EXPLANATORY NOTE

(This explanatory note is not part of the Significant New Activity Notice)

Description

This Significant New Activity (SNAc) Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate), Chemical Abstracts Service (CAS) Registry Number 1661012-65-2. The Notice is now in force and it is legally binding. It is therefore mandatory for a person who intends to use the substance for a significant new activity as defined in the Notice to meet all the applicable requirements set out in the Notice.

A SNAc Notice does not constitute an endorsement from the Minister of the Environment, the Department of the Environment or the Government of Canada of the substance to which it relates, nor does it constitute an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.

Applicability of the Significant New Activity Notice

The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate), CAS Registry Number 1661012-65-2 submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 90 days prior to using the substance for the significant new activity.

In order to address the human toxicity concerns, the Notice requires notification in relation to the use of the substance in the manufacture of a toy or a child care article or a cosmetic, when the concentration of the substance is greater or equal to 0.1% by weight. For example, notification is required if a person plans to manufacture a child care article for sucking or teething of a child in which the substance is present in a concentration of 0.3% by weight. Notification is also required when 1 kilogram or more of the substance is used in a calendar year in a cosmetic, when the concentration of the substance is greater or equal to 0.1% by weight. For example, notification is required if a person plans to use 2 kilogram of the substance in a cosmetic and the substance is present in a concentration of 0.2% by weight.

A SNAN is required 90 days before the use of the substance in a significant new activity.

Activities not subject to the Notice

Uses of the substance that are regulated under the acts of Parliament listed in Schedule 2 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are excluded from the Notice. The Notice also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the provisions of the Act. See subsection 81(6) and section 3 of the Act, and section 3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers for additional information.

Activities involving the use of the substance as a research and development substance or a site-limited intermediate or an export-only product are excluded from the Notice. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers).

Information to be submitted

The Notice sets out the information that must be provided to the Minister 90 days before the day on which the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate), CAS Number 1661012-65-2 is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct risk assessments within 90 days after the complete information is received.

The assessment of the substance identified concerns associated with potential activities involving use of the substance in a toy or a child care article or a cosmetic. This cyclohexane dicarboxylic acid ester chemical substance is structurally similar to a substance that has been identified to cause developmental toxicity effects. The SNAc Notice is issued to gather toxicity information to ensure that the substance will undergo further assessment before significant new activity are undertaken.

The information requirements in the Notice relate to general information in respect of the substance, details surrounding its use, exposure information, and toxicity to human health and the environment. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Transitional Provision

A transitional provision is included in the Notice to facilitate compliance by persons who may already have imported or manufactured up to 100 kg of the substance and started activities with it in concentrations that are greater than or equal 0.1% by weight in the product matrix. The Notice comes into force immediately. However, if the substance is used to manufacture toys or child care article as defined in the Phthalates Regulations or if the substance is used to manufacture or used cosmetic as defined in the Food and Drugs Act, a quantity of less than 100 kg may be used for the period between the publication of the Notice and March 20, 2022. On March 21 2022, the threshold will be lowered.

Compliance

When assessing whether or not a substance is subject to SNAc provisions, a person is expected to make use of information in their possession or to which they may reasonably have access. This means information in any of the notifier's offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheets (SDSs), formerly “Material Safety Data Sheets” (MSDSs). More details are contained in the Regulations Amending the New Substances Notification Regulations (Chemicals and Polymers) and the Export of Substances on the Export Control List Regulations for reference to this amendment.

Although an SDS is an important source of information on the composition of a product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to a SNAc notice due to human health or the environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that the substance is toxic or capable of becoming toxic, the person who is in possession of or that has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of the Act, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the person from whom they obtained the substance. The Substances Management Advisory Note “(ARCHIVED) Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999” provides more detail on this subject.

Under section 86 of the Act, any person who transfers the physical possession or control of a substance subject to a SNAc notice must notify all persons to whom the physical possession or control is transferred of the obligation to comply with the notice, including the obligation to notify the Minister of any SNAc and to provide all the required information outlined above.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

For further information, please contact the Substances Management Information Line (eccc.substances.eccc@canada.ca (email), 1‑800‑567‑1999 (toll-free in Canada), and 819‑938‑3232 (outside of Canada)).

The Act is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Final Residential Indoor Air Quality Guidelines for Carbon Dioxide

Pursuant to subsection 55(3) of the Canadian Environmental Protection Act, 1999, the Minister of Health hereby gives notice of the final Residential Indoor Air Quality Guidelines for Carbon Dioxide (CO2). These guidelines are available on the Health Canada air quality website. This document underwent a public consultation period of 60 days in 2020 and was updated to take into consideration the comments received.

March 19, 2021

David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

The recommended long-term exposure limit for CO2 is 1 000 ppm (based on a 24-hour average). The guidelines are based on effects observed in epidemiological studies in schools or offices and on controlled exposure studies.

Background

Carbon dioxide is an odourless, colourless, and non-flammable gas; the main source of CO2 indoors is the respiration of occupants. Indoor CO2 concentrations are often used as a surrogate for ventilation rate and as an indicator of general indoor air quality. The Residential Indoor Air Quality Guidelines (RIAQGs) are intended to provide a recommended long-term indoor air exposure limit for CO2 that would indicate adequate ventilation as well as minimize risks to human health from CO2 and other indoor air pollutants.

The guideline document also shows that levels in some Canadian homes may exceed the recommended exposure limit, and recommends various risk mitigation measures to improve general indoor air quality and reduce exposure to CO2.

Sources and exposure

Natural sources of atmospheric CO2 include animal and plant respiration, organic matter decomposition, outgassing from water surfaces, forest fires, and volcanic eruptions. Anthropogenic sources of CO2 emissions include the combustion of fossil fuels; building heating and cooling; land-use changes, such as deforestation; and some industrial processes. Indoors, CO2 is mainly produced through the respiration of occupants, but it can also originate from other sources, such as unvented or poorly vented fuel-burning appliances and cigarette smoke.

As ventilation is the primary means of removal of CO2 from indoor environments, poorly ventilated homes or homes with unvented or poorly vented fuel-burning appliances may have elevated CO2 concentrations, especially if several occupants are present. Indoor CO2 concentrations are often used as a surrogate for ventilation rate and as an indicator for other occupant-derived pollutant (bioeffluent) concentrations and odours. Many building standards and guidelines for CO2 were established based on target CO2 concentrations that would indicate adequate ventilation for occupant comfort with respect to bioeffluents (odours) and not on direct health effects of CO2.

Health effects

Studies in humans in school or office settings have found associations between CO2 exposure and mucous membrane or respiratory symptoms, rhinitis, neurophysiological symptoms, a lack of concentration, headaches, dizziness, heavy-headedness, tiredness, and decreased performance on tests or in conducting tasks. Studies in laboratory animals were generally at high concentrations of CO2; however, the results from studies investigating the neurological effects of CO2 exposure or its effects on the developing brain support the observations from human studies.

Indigenous peoples may be considered more vulnerable to the health effects of CO2 because as close to one fifth of the Indigenous population lived in crowded housing (on and off reserve) in 2016, which is higher than the non-Indigenous population. The portion of First Nations people with registered or treaty Indian status living in a crowded dwelling was higher on reserve (over one third).

Individuals living in affordable housing are also considered to be more vulnerable to the health effects of air pollution in general, as they are more likely to live in homes with poor conditions.

Infants and children are also considered a vulnerable population, as they may be exposed to elevated indoor CO2 levels in environments outside of their home, such as schools and daycare centres. In addition, because of their size, children inhale more air in relation to their body weight than adults. Infants and children may also be more susceptible than adults to the health effects of air contaminants due to differences in their ability to metabolize, detoxify, and excrete contaminants, and because they undergo rapid growth and development.

Individuals with pre-existing health conditions (such as allergies and asthma) were found to be more susceptible to the mucous membrane and respiratory effects of CO2 than those without these conditions. Patients with panic disorder were found to be more susceptible to the anxiogenic effects of CO2 compared to healthy subjects. Due to the physiological and metabolic actions of CO2 in the body, it is expected that individuals with cardiovascular conditions may also be more susceptible to the health effects of elevated CO2 exposure.

Risk management recommendations

Measured data confirms there are Canadian homes, schools, and daycare centres in which the recommended exposure limit for CO2 is exceeded. Therefore, there may be an increased risk of respiratory symptoms, headaches, dizziness and tiredness, and decreased test performance.

As CO2 levels are strongly correlated with occupant density and ventilation, achieving a CO2 level in the home that is below the recommended exposure limit should be feasible with uncrowded housing and adequate ventilation. The following strategies are proposed:

In terms of implementation of CO2 reduction strategies, specifically increased ventilation, ambient air quality must be considered. During periods of poor ambient air quality, such as those experienced during forest fire events, reducing air intake and, therefore, infiltration of ambient air pollutants, may be more beneficial from a health risk perspective, compared to reducing indoor CO2 levels to below the recommended exposure limit.

Application of the guidelines

The RIAQGs documents serve as a scientific basis for activities to evaluate and reduce the risk from indoor air pollutants including the following:

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1)footnote a of the Food and Drugs Actfootnote b, makes the annexed Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.

Ottawa, March 1, 2021

Patricia Hajdu
Minister of Health

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

Interpretation

Definitions

1 (1) The following definitions apply in this Interim Order.

business day
means a day other than a Saturday or a Sunday or other holiday. (jour ouvrable)
pest control product
has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)

Other words and expressions

(2) Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Food and Drug Regulations or the Medical Devices Regulations, as applicable.

Drugs

Definitions

Definitions

2 The following definitions apply in this section and in sections 3 to 13.

biocide
means a drug that
  • (a) is not a pest control product whose use is regulated under the Pest Control Products Act; and
  • (b) is intended to destroy or irreversibly inactivate micro-organisms on an inanimate surface, other than the surface of an invasive device. (biocide)
designated biocide
means a biocide that is set out in the List of Biocides for Exceptional Importation and Sale. (biocide désigné)
designated drug
means a drug that is set out in the List of Drugs for Exceptional Importation and Sale or that is part of a class of drugs that is set out in that List. It does not include a biocide. (drogue désignée)
drug
does not include
  • (a) a veterinary health product;
  • (b) a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations;
  • (c) a cell, organ or tissue as those terms are defined in section 1 of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations; and
  • (d) blood as defined in section 1 of the Blood Regulations. (drogue)
List of Biocides for Exceptional Importation and Sale
means the List of Biocides for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des biocides destinés aux importations et aux ventes exceptionnelles)
List of Drugs for Exceptional Importation and Sale
means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)

Exceptional Importation and Sale

Drugs Other than Biocides

Non-application

3 Subject to section 4 and subsection 5(1), the following provisions of the Food and Drug Regulations do not apply to a designated drug that is imported:

Prohibition — sale

4 (1) The prohibition set out in section C.01.016 of the Food and Drug Regulations applies to the sale of a designated drug that is imported.

Serious adverse drug reaction reporting

(2) Despite subsection (1), the manufacturer of the designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 of those Regulations.

Finished product testing

5 (1) Section C.02.019 of the Food and Drug Regulations does not apply to an importer in respect of a designated drug that they import.

Timing of testing

(2) An importer of a designated drug must perform the finished product testing on a sample of the drug that is taken either

Visual inspection

(3) If the importer receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, the importer must visually inspect the lot or batch to confirm the identity of the product.

Non-application

(4) Subsections (2) and (3) do not apply to the importer if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and both of the following conditions are met:

Information request

6 (1) The Minister may request from an importer of a designated drug any of the information referred to in paragraphs C.02.020(1)(a), (b) and (d) of the Food and Drug Regulations.

Obligation to provide information

(2) The importer must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Non-application

7 Subsections 5(2) and (3) and section 6 do not apply in respect of a designated drug that is not subject to Division 2 of Part C of the Food and Drug Regulations.

Notification

8 (1) An importer of a designated drug must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the drug is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

Accessibility of information

9 An importer of a designated drug that sells it must ensure that the information referred to in paragraph 8(2)(d) is available

Biocides

Non-application

10 Subject to section 11, the following provisions of the Food and Drug Regulations do not apply to a designated biocide that is imported:

Prohibition — sale

11 (1) The prohibition set out in section C.01.016 of the Food and Drug Regulations applies to the sale of a designated biocide that is imported.

Serious adverse drug reaction reporting

(2) Despite subsection (1), the manufacturer of the designated biocide is required to comply only with the requirements set out in sections C.01.017 and C.01.019 of those Regulations.

Notification

12 (1) An importer of a designated biocide must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the biocide is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

Accessibility of information

13 An importer of a designated biocide that sells it must ensure that the information referred to in paragraph 12(2)(d) is available

Medical Devices

Definitions

Definitions

14 The following definitions apply in this section and in sections 15 to 18.

List of Medical Devices — Notification of Shortages
means the List of Medical Devices — Notification of Shortages that is published by the Government of Canada on its website, as amended from time to time. (Liste d'instruments médicaux — avis de pénuries)
shortage
means a situation in which the manufacturer of a medical device is unable to meet the demand for the device or for any component, accessory or part of the device. It does not include a situation in which the manufacturer is also the manufacturer of a substitute medical device, component, accessory or part and is able to meet the demand for it. (pénurie)
specified medical device
means a medical device that is set out in the List of Medical Devices — Notification of Shortages or that is part of a category of medical devices that is set out in that List. (instrument médical inscrit)

Shortages — Notification

Shortage — information

15 (1) Subject to subsection (5), if a shortage of a specified medical device — or of its components, accessories or parts — exists or is likely to occur, the manufacturer and the importer of the device must each provide the following information to the Minister electronically in a format specified by or acceptable to the Minister:

Timing

(2) Subject to subsection (6), the information must be provided

Updates

(3) If any of the information that was provided changes, the manufacturer or importer must provide the new information to the Minister electronically in a format specified by or acceptable to the Minister within two business days after the day on which the manufacturer or importer makes or becomes aware of the change.

End of shortage

(4) Within two business days after the day on which the manufacturer is able to meet the demand for the specified medical device or for its components, accessories or parts, the manufacturer or importer must notify the Minister electronically in a format specified by or acceptable to the Minister of the manufacturer's ability to do so.

No obligation to provide information

(5) The manufacturer or importer need not provide the information if, within the applicable period referred to in paragraph (2)(a) or (b), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the specified medical device or for its components, accessories or parts within 30 days after the day on which the manufacturer or importer anticipated or became aware of the shortage.

Exception

(6) Despite subsection (5), if the manufacturer or importer subsequently concludes that the manufacturer is unable to meet the demand within the 30-day period referred to in that subsection, the manufacturer or the importer must provide the information within five business days after the day on which the manufacturer or importer reaches that conclusion.

Permission

16 (1) Despite subsection 15(1), the manufacturer of a specified medical device may permit the importer of the device to provide the information referred to in that subsection on the manufacturer's behalf if the information that the manufacturer and importer must provide is identical.

Notification

(2) The manufacturer must notify the Minister electronically in a format specified by or acceptable to the Minister if the manufacturer has permitted the importer to provide the information on the manufacturer's behalf.

Publication of information

17 (1) The Minister must publish the information that he or she receives under section 15 on the Government of Canada website.

Exception

(2) Subsection (1) does not apply if the Minister has reasonable grounds to believe that a situation, in respect of which information was provided under section 15, does not meet the definition shortage in section 14.

Shortages — Request for Information

Information request

18 (1) The Minister may request that the manufacturer or the importer of a medical device, or any distributor of the device, provide the Minister with information in respect of the device that is in their control if the Minister has reasonable grounds to believe that

Obligation to provide information

(2) The manufacturer, importer or distributor must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Restriction

(3) The information that may be requested does not include personal information, as defined in section 3 of the Privacy Act, in respect of a patient or user or any other person whose health or safety may be adversely affected by the shortage of the medical device.

Interpretation

(4) In this section, a reference to a medical device includes its components, accessories and parts.

Exceptional Importation and Sale

Definitions

19 The following definitions apply in this section and in sections 20 to 22.

designated medical device
means a medical device that is set out in the List of Medical Devices for Exceptional Importation and Sale or that is part of a category of medical devices that is set out in that List. (instrument médical désigné)
List of Medical Devices for Exceptional Importation and Sale
means the List of Medical Devices for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d'instruments médicaux destinés aux importations et aux ventes exceptionnelles)

Non-application

20 The provisions of the Medical Devices Regulations — other than sections 44 to 65.1 — do not apply to a medical device if the device is

Notification

21 (1) An importer of a designated medical device must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the device is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

Accessibility of information

22 An importer of a designated medical device that sells it must ensure that the information referred to in paragraph 21(2)(c) is available

Food for a Special Dietary Purpose

Definitions

Definitions

23 The following definitions apply in this section and in sections 24 to 26.

designated food for a special dietary purpose
means a food for a special dietary purpose that is set out in the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale or that is part of a class of foods for a special dietary purpose that is set out in that List. (aliment à des fins diététiques spéciales désigné)
foreign regulatory authority
means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of a food for a special dietary purpose within its jurisdiction and that may take enforcement action to ensure that such foods marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)
List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale
means the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d'aliments à des fins diététiques spéciales destinés aux importations et aux ventes exceptionnelles)

Exceptional Importation and Sale

Non-application

24 (1) Sections A.01.014 and A.01.016 of the Food and Drug Regulations, the provisions of Part B of those Regulations — other than sections B.24.100 and B.24.300 — and the provisions of Part D of those Regulations do not apply to a food for a special dietary purpose that is imported if the food is

Exemptions

(2) A food for a special dietary purpose that is imported and that is referred to in either paragraph (1)(a) or (b) is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence of any of the following substances or materials:

Notification

25 (1) An importer of a designated food for a special dietary purpose must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the food is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

Accessibility of information

26 An importer of a designated food for a special dietary purpose that sells it must ensure that the information referred to in subparagraphs 25(2)(e)(ii) to (vii) is available

Transitional Provisions

Definitions

27 The following definitions apply in sections 28 to 32.

designated hand sanitizer
means a drug as defined in section 2 that
  • (a) is not a pest control product whose use is regulated under the Pest Control Products Act; and
  • (b) is intended to reduce or inactivate micro-organisms on human skin. (désinfectant pour les mains désigné)
Interim Order No. 1
means the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister on March 30, 2020 and published in the Canada Gazette, Part I, on April 11, 2020, as it read immediately before the day on which this Interim Order is made. (arrêté d'urgence no 1)

Requests

28 A request made by the Minister under subsection 7(1) of Interim Order No. 1 before the day on which this Interim Order is made is deemed to be a request made under subsection 6(1).

Drugs — six months after Interim Order is made

29 (1) An importer who has notified the Minister under section 9 of Interim Order No. 1 in respect of a designated drug, as defined in section 2, need not comply with paragraph 9(b) in respect of the drug during the six-month period following the day on which this Interim Order is made.

Medical devices — six months after Interim Order is made

(2) An importer who has notified the Minister under section 22 of Interim Order No. 1 in respect of a designated medical device, as defined in section 19, need not comply with paragraph 22(b) in respect of the device during the six-month period following the day on which this Interim Order is made.

Foods — six months after Interim Order is made

(3) An importer who has notified the Minister under section 26 of Interim Order No. 1 in respect of a designated food for a special dietary purpose, as defined in section 23, need not comply with paragraph 26(b) in respect of the food during the six-month period following the day on which this Interim Order is made.

Permission — six-month period

30 (1) Subject to subsection (2), a person who, during the period in which Interim Order No. 1 was in effect, conducted an activity referred to in Table I to section C.01A.008 of the Food and Drug Regulations only in respect of a designated hand sanitizer, without holding an establishment licence that authorized them to do so, may continue to do so until the end of the six-month period that begins on the day on which this Interim Order is made.

Cessation of permission — application filed

(2) If, before the end of the six-month period referred to in subsection (1), the person submits in accordance with section C.01A.005 or C.01A.006 of the Food and Drug Regulations an application to obtain or amend an establishment licence to authorize the activity that they have been conducting in respect of the designated hand sanitizer and the application contains the statements referred to in subsection (3), the person may continue to conduct the activity in respect of the hand sanitizer without holding an establishment licence that authorizes them to do so until

Statements in application

(3) The application is to include statements indicating that

Exception — withdrawal of application

(4) Despite subsection (2), if the person withdraws their application during the six-month period referred to in subsection (1), they may continue to conduct, until the end of that period, the activity in respect of the designated hand sanitizer without holding an establishment licence that authorizes them to do so.

Application for drug identification number

31 Section 12 of Interim Order No. 1 applies in respect of an application for a drug identification number that is for a designated hand sanitizer and that was made under subsection C.01.014.1(1) of the Food and Drug Regulations during the period in which Interim Order No. 1 was in effect.

New drug submission

32 Section 13 of Interim Order No. 1 applies in respect of a new drug submission that is for a designated hand sanitizer and that was filed under subsection C.08.002(2) of the Food and Drug Regulations during the period in which Interim Order No. 1 was in effect.

Repeal

Repeal

33 The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 30, 2020 and published in the Canada Gazette, Part I, on April 11, 2020, is repealed.

EXPLANATORY NOTE

(This note is not part of the Interim Order.)

Proposal

The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2) was made by the Minister of Health on March 1, 2021. IO No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 1) made by the Minister on March 30, 2020, and approved by the Governor in Council (GIC) on April 8, 2020. It extends and modifies certain measures for drugs, medical devices and foods for special dietary purposes introduced in IO No. 1. These measures continue to be necessary to help prevent and alleviate the effects of shortages that are caused or exacerbated, directly or indirectly, by COVID-19.

The Minister may make interim orders under subsection 30.1(1) of the Food and Drugs Act, if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. Such an order ceases to have effect 14 days after it is made unless it is approved by the Governor in Council.

Objective

The objective of IO No. 2 is to help prevent or alleviate the effects of health product shortages caused or exacerbated, directly or indirectly, by COVID-19.

Background

COVID-19 is a new disease never before seen in humans. It is an infectious respiratory disease caused by a strain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it may cause pneumonia, severe acute respiratory syndrome, kidney failure and death.

The disease was first detected in Wuhan, China, in December 2019. The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. Originally seen to be a local outbreak, COVID-19 has now affected most countries across the globe. There are now more than 109 million cases and over 2 million people have lost their lives. As of February 17, 2021, the number of confirmed cases in Canada has exceeded 800 000. However, the situation continues to evolve.

From the outset, the COVID-19 pandemic created global supply chain challenges. Shortages of health products are a growing global problem with particular implications for smaller markets like Canada. Approximately 83% of drug manufacturing activity is conducted outside of Canada and roughly 68% of drugs in final dosage form are imported. As well, imports account for nearly 75% of Canada's medical device market. Many of these imports are from single suppliers, making Canada particularly vulnerable to unforeseen events that disrupt manufacturing and distribution.

The COVID-19 pandemic has made this situation worse. It has disrupted supply chains and caused an increase in demand for certain health products used to prevent, treat and manage COVID-19. Product categories regulated under the Food and Drugs Act that have experienced an increase of shortages or demand, or where the risk of a shortage has become more pronounced, include

Since March 2020, Health Canada has responded to 45 Tier 3 (highest impact) drug shortages, compared to only 10 Tier 3 shortages in 2019. Of the over 400 medical device shortage reports received as of February 17, 2021, 281 shortages were confirmed and posted. Before IO No. 1 was made, Health Canada was made aware of only 27 medical device shortages from 2015 to February 2020. At that time, there were no mandatory requirements to report medical device shortages in Canada. While the supply and demand levels for some health products are stabilizing, the need for vigilance continues. The federal government remains focused on the health and safety of Canadians during the COVID-19 pandemic.

Health Canada plays an active role in mitigating the impact of shortages on Canadians. The Department works closely with provinces and territories, manufacturers and others in the supply chain to ensure that Canadians have access to the prescription drugs and medical devices they need. Regulatory requirements for manufacturers to report drug shortages came into force in March 2017. These require manufacturers to report certain drug shortage and discontinuation information on a third-party website. There are no other existing requirements in legislation or permanent regulation directly related to medical devices or other health product shortages.

To date, the federal government has put in place a number of temporary measures to support efforts to alleviate shortages that occur and to help prevent new shortages. For example, in March 2020, Health Canada implemented an interim policy to address the unprecedented demand for disinfectants and hand sanitizers in Canada at the start of the pandemic. This interim policy supplements the Canadian supply by facilitating importation of foreign products that do not fully meet regulatory requirements under the Food and Drugs Act but do not compromise the safety of Canadians. These measures have enabled Health Canada to facilitate the availability of supplies of these products for Canadians. As of February 17, 2021, the sale and import of 670 products (surface disinfectants and hand sanitizers) have been permitted under the policy.

As a part of Health Canada's efforts to prevent and alleviate shortages of key products, IO No. 1 was made by the Minister on March 30, 2020. Its approval by the GIC on April 8, 2020, extended its operation by up to a year. IO No. 1 permitted the exceptional importation of specified health products that may not fully meet Canadian regulatory requirements, but are manufactured to comparable standards, to help alleviate a shortage. As of February 17, 2021, 56 drugs, 265 medical devices and 2 foods for a special dietary purpose were permitted for exceptional importation and sale under this interim order. IO No. 1 also mandated the reporting of shortages of select medical devices that are critical during the pandemic, similar to a requirement already in place for drugs. These and other measures undertaken by the Department in partnership with manufacturers and importers have led to the resolution of 25 Tier 3 drug shortages and 118 medical device shortages.

The Minister also made two more interim orders focused on drug shortages over the past year.

The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 was made by the Minister on October 16, 2020, and approved by the GIC on October 23, 2020. This interim order provides additional tools to address drug shortages. These include the ability to require specific information about a shortage related to COVID-19 and to impose terms and conditions on the market authorization for a drug related to a shortage.

The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was made by the Minister on November 17, 2020, and approved by the GIC on December 4, 2020. This introduces new measures to help prevent foreign bulk importation of drugs intended for the Canadian market from causing or worsening a drug shortage in Canada. An example is the program recently established in the United States.

Without further action, IO No. 1 would have expired on March 30, 2021. Once IO No. 1 expired, products previously permitted to be imported and sold to address a shortage would no longer be permitted. As well, Health Canada would be unable to permit new products to be imported and sold through exceptional importation. This would worsen the impact of these shortages on Canadians.

Moreover, reporting of medical device shortages would no longer be required, which would have reduced Health Canada's ability to monitor shortages of critical medical devices. Urgent action is required to maintain these authorities, enabling Health Canada to continue helping to prevent and alleviate the effects of health product shortages caused or exacerbated, directly or indirectly, by COVID-19.

Implications

Exceptional importation

Under IO No. 2, the exceptional importation and sale of drugs, medical devices, and foods for a special dietary purpose will continue to be permitted to address shortages of these products that are caused or made worse, directly or indirectly, by COVID-19. Products governed by IO No. 2 may be imported into Canada, provided they were manufactured with similar high quality and manufacturing standards to those required for Canadian-approved products.

Under IO No. 1, the Minister maintained up-to-date lists of the drugs, medical devices, and foods for a special dietary purpose eligible for exceptional importation on Health Canada's website. These lists are again being incorporated by reference under IO No. 2 and will continue to be maintained. Industry guidance outlines how companies can submit proposals for adding a non-compliant drug, medical device, or food for a special dietary purpose to these lists to address a shortage. Health Canada may also add a product to a list without receiving a specific proposal from a company if requested by a public health official, such as the Chief Public Health Officer of the Public Health Agency of Canada, if necessary to address a potential shortage. Health Canada reviews proposals based on a number of factors, including but not limited to product type and availability of supply.

IO No. 2 also formalizes a regulatory framework to permit the exceptional importation and sale of surface disinfectants (also called biocides) to address increased demand. It modifies the definition of a “biocide” that was defined in IO No. 1 so that the term refers only to disinfectants, and not hand sanitizers, which are regulated differently. The exceptional importation framework for biocides in IO No. 2 will replace Health Canada's earlier interim policy approach for imported disinfectants. An up-to-date list of biocides eligible for exceptional importation will be maintained. Many of the biocides that were eligible for import and sale under Health Canada's previous policy approach will continue to be permitted under IO No. 2.

IO No. 2 modifies regulatory flexibilities previously made available to regulated parties that manufacture, import, and/or sell hand sanitizers, as the domestic production capacity for these products has now stabilized. Under IO No. 1, companies were permitted to conduct activities related to drug-based hand sanitizers without a drug establishment licence (DEL). IO No. 2 reintroduces the requirement for companies to have a DEL to conduct regulated activities related to drug-based hand sanitizers. Companies wishing to continue conducting licensable activities related to drug-based hand sanitizers will have six months to apply for a DEL. After applying, companies can continue those activities until a determination is made with respect to their applications.

In addition, IO No. 2 no longer permits companies to provide Health Canada with label text in place of a label mock-up as part of an application for a drug identification number (DIN) or a new drug submission regarding a drug-based hand sanitizer. However, any application seeking market authorization for a product that is pending a decision at the time IO No. 2 comes into force will be considered under the terms of IO No. 1.

IO No. 2 also modifies Health Canada's approach to official languages for products that arrive in Canada through exceptional importation. Under IO No. 1, guidance for industry indicated the Department's expectation for importers to ensure that information on the safe use of the product be available in French and English. IO No. 2 makes that regulatory requirement explicit. Importers wishing to keep their products in the Canadian market will have six months to come into compliance.

Any importer who is permitted for exceptional importation and sale under IO No. 2 must notify the Minister electronically, in a format that is specified by, or acceptable to, the Minister, at least five business days before importation. These products will still be subject to some of the requirements set out in the Food and Drugs Act and its regulations, including reporting adverse drug reactions, recall requirements and mandatory problem reporting (medical devices).

Medical device shortage reporting

IO No. 2 also continues the requirement for manufacturers and importers of medical devices considered critical during the COVID-19 pandemic to notify the Minister of shortages of those medical devices introduced in IO No. 1. The notification must happen within five business days of becoming aware of an actual or anticipated shortage. Information is to be submitted electronically in a format specified by, or acceptable to, the Minister.

IO No. 2 clarifies that the shortage reporting requirement for substitute devices, components, accessories or parts should be based only on the manufacturer's own capacity, supply and orders. It does not include a situation where the device is on back order for less than 30 days. These changes bring shortage reporting requirements into better alignment with those of the U.S. Food and Drug Administration, thus avoiding confusion for manufacturers. They also clarify the circumstances under which manufacturers should report a shortage and will improve Health Canada's oversight of medical device shortages.

Under IO No. 1, the Minister maintained an up-to-date list of medical device shortages and an up-to-date list of specified medical devices for which shortages must be reported. Products appearing on the list of specified medical devices are selected based on signals from public reports, industry, provinces and territories, or other stakeholders. These lists are being reincorporated under IO No. 2 and will continue to be maintained.

IO No. 1 introduced an authority for the Minister to request additional information about a shortage of a medical device, or its components, accessories, parts or consumable materials, that had been reported to Health Canada. However, the ongoing pandemic has underscored the need for more robust information respecting medical device shortages.

The authority in IO No. 1 was effective in obtaining supplemental information from manufacturers and importers who have reported a shortage to Health Canada. However, while assessing the impact that actual or anticipated shortages may have had on Canadians, it was often necessary to gather information from additional companies. For example, Health Canada has had to request information from other manufacturers and importers to determine the supply of potential substitute medical devices. Similarly, Health Canada has also requested supply and demand information from companies to validate signals received from other sources to determine if a risk of shortage existed.

To date, industry has provided this information when requested and Health Canada has worked with companies to address shortages. However, expanding the Minister's authority to compel information on medical device shortages will facilitate timely access to needed information when companies would not voluntarily provide the information. This will enable Health Canada to assess and respond more quickly to an actual or anticipated shortage, which could limit or prevent harm to Canadians.

Therefore, IO No. 2 introduces an expanded authority for the Minister to request information on existing and potential medical device shortages that have not been reported or that are not subject to an obligation to report. The Minister can request this information from a manufacturer, importer or distributor of a medical device if the Minister has reasonable grounds to believe that

The Minister can only use this power to request information that is in the control of a manufacturer, importer or distributor. This power cannot be used to require them to create new information in response to the Minister's request. The decision to compel information through IO No. 2 must be reasonable, factual, and flow logically from the signals available to the Minister. These signals may include complaints, media reports, shortage reports or knowledge of broader supply chain issues. Industry, provinces and territories, or other stakeholders may also identify potential indications of shortages.

A manufacturer, importer or distributor required to provide information must do so electronically in a format that is specified by, or acceptable to, the Minister. The required information is to be submitted within the time frame specified by the Minister. However, the Minister cannot require the information to be submitted with less than 24 hours' notice, unless the Minister has reasonable grounds to believe there is a serious and imminent health risk. Details on the process for providing information, and the types of information that may be requested, have been provided to industry through the guidance document on medical device shortages.

Enforcement and compliance

Enforcement of IO No. 2 takes place through inspection, compliance promotion, monitoring and verification. Health Canada will continue to conduct compliance promotion sessions with regulated parties to increase their understanding of their new obligations and to minimize non-compliance.

Health Canada has a number of enforcement powers available to address non-compliance with the Food and Drugs Act or an issue of public health and safety. Actions that could be taken against regulated parties violating the terms of the IO include

Health Canada will choose the most appropriate tool to help ensure compliance and to mitigate any risks to health, informed by the specifics of each case and in alignment with the Compliance and enforcement policy framework and the Compliance and enforcement policy for health products (POL-0001).

Consultation

Health Canada received comments on IO No. 1 through ongoing discussions with stakeholders, industry conferences and two focused stakeholder engagement sessions held on June 4, 2020, and September 3, 2020. These comments were generally supportive. Stakeholders understood the need to continue the frameworks and authorities put in place through IO No. 1. The Department sought to accommodate stakeholder feedback on IO No. 2 where possible.

Some stakeholders wanted more clarity on how the interim policy previously used to import disinfectants and hand sanitizers would change. IO No. 2 clarifies the Department's approach to these products by placing the agile regulatory measures previously offered through the interim policy in a more formal framework based on a list incorporated by reference. Some stakeholders also raised concerns that the shift from the interim policy to the new framework in IO No. 2 will now only encompass disinfectants that are imported and are not available to Canadian manufacturers. However, Health Canada continues to offer other agile measures to Canadian manufacturers such as expediting review times for product applications that only contain direct or indirect SARS-CoV-2 claims.

Other concerns raised by biocide stakeholders included

IO No. 2 addresses some of these concerns. It clarifies that importers must make information that permits the safe use of a product available in both French and English and in a manner that is accessible to consumers.

Medical device stakeholders wanted greater clarity about Canadian shortage reporting requirements. IO No. 2 clarifies the reporting requirements by specifying that shortages should be based only on the manufacturer's own capacity, supply and orders, and do not include situations in which the manufacturer produces another device that can be substituted for the device in shortage. In addition, IO No. 2 excludes the reporting of back orders that are less than 30 days. These changes also bring Canadian requirements into closer alignment with the United States.

The expanded authority to request information related to medical device shortages has been designed to address stakeholder concerns by specifying that the Minister can only request information that is in the control of the manufacturer, importer or distributor so that this power cannot be used to require them to create new information. As well, a provision was added that specifies the Minister can only compel information if there are reasonable grounds to believe that the manufacturer, importer or distributor would not provide the information without a legal obligation. Additionally, a minimum timeline of 24 hours for information requests, unless there is a serious and imminent risk of injury to human health, has been included in the IO No. 2.

In January and February 2021, Health Canada consulted on IO No. 2 with a range of stakeholders, including

Sessions focused on how IO No. 2 differs from IO No. 1 and how the authorities will be used in the future.

Health Canada also accepted written comments from stakeholders between January 22, 2021, and February 11, 2021. Stakeholders were largely supportive of IO No. 2 and the proposed changes from IO No. 1. A small number of stakeholders consider the new requirement for information to be made available in French and English to be burdensome. However, most stakeholders did not indicate it would impact their choice to make use of the exceptional importation frameworks.

In general, stakeholders indicated that the tools in IO No. 2 were effective in helping to address shortages. They did not raise significant concerns.

Health Canada has been in contact with representatives of provincial and territorial governments and other stakeholders, such as health care providers and patient advocacy groups. They are supportive of IO No. 2 and its measures to address shortages of drugs, biocides, medical devices and foods for a special dietary purpose in light of the current COVID-19 global pandemic.

Contact

Catherine Hudon
Director
Compliance Policy and Regulatory Affairs
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Address Locator: 1907A
200 Eglantine Driveway
Jeanne Mance Building
7th Floor, Room 705A
Tunney's Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 343‑540‑8524
Email: hc.prsd-questionsdspr.sc@canada.ca

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1)footnote a of the Food and Drugs Actfootnote b, makes the annexed Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Ottawa, March 1, 2021

Patricia Hajdu
Minister of Health

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Interpretation

Definitions

1 (1) The following definitions apply in this Interim Order.

COVID-19 medical device
means a medical device that is manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). (instrument médical destiné à être utilisé à l'égard de la COVID-19)
foreign regulatory authority
means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)
incident
means any incident involving a COVID-19 medical device that
  • (a) is related to a failure of the device, a deterioration in its quality or effectiveness or any inadequacy in its labelling or in its directions for use; or
  • (b) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur. (incident)
List of Medical Devices for Expanded Use
means the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic that is published by the Government of Canada on its website, as amended from time to time. (Liste d'instruments médicaux destinés à un usage supplémentaire)
Regulations
means the Medical Devices Regulations. (Règlement)

Words and expressions

(2) Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Regulations.

Application

Importation and sale

2 (1) Part 1 of the Regulations, with the exception of the provisions set out in subsection (2), does not apply to the importation or sale of a COVID-19 medical device if the following conditions are met:

Application of Regulations

(2) The following provisions of the Regulations apply in respect of the importation or sale of a COVID-19 medical device if the conditions set out in paragraphs (1)(a) to (d) are met:

Importation — Class I medical device

(3) Despite paragraph (2)(a), subsection 44(3) of the Regulations does not apply to a person who imports a Class I COVID-19 medical device from the manufacturer of that device.

General

Establishment licence — suspension or cancellation

3 An importer or distributor must not import or sell a COVID-19 medical device if their establishment licence has been

Application

4 (1) An application for the authorization for importation or sale of a COVID-19 medical device must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

Class III and IV devices

(2) An application in respect of a Class III or IV COVID-19 medical device must contain, in addition to the information and material referred to in subsection (1), the following:

Foreign regulatory authority

(3) Despite subsection (1) and, if applicable, subsection (2), the application need not include the information and material referred to in paragraph (1)(g) and, if applicable, subsection (2) if the applicant provides information that demonstrates that the sale of the COVID-19 medical device is authorized by a foreign regulatory authority and that authorization has not been suspended.

Issuance

5 The Minister must issue the authorization for importation or sale if the following requirements are met:

Amendment

6 A person must not sell a COVID-19 medical device in respect of which an authorization for importation or sale has been issued and has not been cancelled if any of the matters referred to in subsection 4(1) and, if applicable, subsection 4(2) are significantly different from the information or material contained in the application, unless

Terms and conditions

7 The Minister may, at any time, impose terms and conditions on the authorization for importation or sale of a COVID-19 medical device or amend those terms and conditions.

Cancellation

8 The Minister may cancel the authorization for importation or sale of a COVID-19 medical device by written notice, giving reasons, if

Additional information and material

9 The Minister may request a person who has submitted an application for an authorization for importation or sale of a COVID-19 medical device or a holder of such an authorization to submit any additional information or any material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or cancel the authorization.

Labelling

10 A person must not import or sell a COVID-19 medical device unless the device has a label that sets out the following information:

Label information — English or French

11 (1) Subject to subsection (3), the information required by section 10 must, as a minimum, be in either English or French.

Directions for use — other official language

(2) Subject to subsection (3), if the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language must be made available by the manufacturer as soon as possible at the request of the purchaser.

Certain information — English and French

(3) In respect of a COVID-19 medical device to be sold to the general public, the information required by paragraphs 10(a) and (e) to (j) must, as a minimum, be in both English and French.

Importation — copy of authorization

12 Each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the authorization for importation.

Incident reporting

13 The holder of an authorization for importation or sale of a COVID-19 medical device must, within 10 days after becoming aware of an incident in Canada, report the incident to the Minister and specify the nature of the incident and the circumstances surrounding it.

Expanded use

14 Part 1 of the Regulations does not apply to the importation or sale of a medical device or a COVID-19 medical device that is set out in column 1 of the List of Medical Devices for Expanded Use for the expanded use set out in column 2 if the following conditions are met:

Supplementary information

15 The Minister must publish on a Government of Canada website supplementary information pertaining to the expanded use of a medical device or a COVID-19 medical device, including

Information request

16 (1) The Minister may request from the holder of a medical device licence or the holder of an authorization for importation or sale of a COVID-19 medical device, in respect of a device set out in column 1 of the List of Medical Devices for Expanded Use, any information in relation to its expanded use set out in column 2 that the holder possesses or to which they have reasonable access.

Obligation to provide information

(2) The holder of the licence or authorization must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit must not be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Transitional Provisions

Definition of Interim Order No. 1

17 In subsection 18(2) and sections 20 to 27, Interim Order No. 1 means the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister on March 18, 2020 and published in the Canada Gazette, Part I, on March 28, 2020.

Labelling — six months after making

18 (1) A person need not comply with section 11 during the period beginning on the day on which this Interim Order is made and ending six months after that day.

Sale

(2) Despite subsection (1), a person, other than a manufacturer, may, during the period beginning six months after the day on which this Interim Order is made and ending nine months after that day, sell a COVID-19 medical device that is not labelled in accordance with subsections 11(1) and (3), if it is labelled in accordance with Interim Order No. 1 as it read immediately before the day on which this Interim Order is made.

Importers and distributors — six months after making

19 An importer or distributor need not comply with sections 44 and 45, subsection 46.1(1) and sections 48 and 57 to 61 of the Regulations during the period beginning on the day on which this Interim Order is made and ending six months after that day.

Applications

20 An application for an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 1 before the day on which this Interim Order is made and in respect of which no decision has been made before that day is deemed to be an application for an authorization for importation or sale of a COVID-19 medical device submitted under this Interim Order.

Authorizations

21 An authorization for importation or sale of a COVID-19 medical device that was issued by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been cancelled before that day is deemed to be an authorization for importation or sale of a COVID-19 medical device issued under this Interim Order.

Amendment applications

22 An application to amend an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 1 before the day on which this Interim Order is made and in respect of which no decision has been made before that day is deemed to be an application to amend an authorization for importation or sale of a COVID-19 medical device submitted under this Interim Order.

Amended authorization

23 An authorization for importation or sale of a COVID-19 medical device that was amended by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been cancelled before that day is deemed to be an authorization for importation or sale of a COVID-19 medical device amended to the same extent under this Interim Order.

Terms and conditions

24 Any terms and conditions that were imposed on an authorization for importation or sale of a COVID-19 medical device by the Minister under Interim Order No. 1 before the day on which this Interim Order is made are deemed to be terms and conditions imposed on the authorization for importation or sale of a COVID-19 medical device under this Interim Order.

Request — additional information and material

25 A request that was made by the Minister under Interim Order No. 1 before the day on which this Interim Order is made for additional information or material, including samples, is deemed to be a request for additional information or material under this Interim Order.

Expanded use

26 A medical device or a COVID-19 medical device, its expanded use and the supplementary information pertaining to that use that were set out in the List of Medical Devices for Expanded Use under Interim Order No. 1 before the day on which this Interim Order is made are deemed to be set out in that List under this Interim Order.

Request — expanded use information

27 A request that was made by the Minister under Interim Order No. 1 before the day on which this Interim Order is made for information in relation to the expanded use of a medical device or a COVID-19 medical device set out in the List of Medical Devices for Expanded Use is deemed to be a request for information in relation to the expanded use under this Interim Order.

Repeal

28 The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 18, 2020 and published in the Canada Gazette, Part I, on March 28, 2020, is repealed.

EXPLANATORY NOTE

(This note is not part of the Interim Order.)

Proposal

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 2) was made by the Minister of Health on March 1, 2021, in accordance with subsection 30.1(1) of the Food and Drugs Act. The Minister may make an interim order if immediate action may be required to deal with a significant risk, direct or indirect, to health, safety or the environment.

IO No. 2 repeals the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, which came into force on March 18, 2020.

This new interim order maintains many of the flexibilities of the previous interim order, including the consideration of urgent public health needs. These flexibilities are needed to assess evidence that demonstrates the safety and effectiveness of medical devices. IO No. 2 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim order.

Further, IO No. 2 introduces new requirements for medical devices authorized under this new interim order or the previous interim order

These new requirements align with those in the Medical Devices Regulations.

In accordance with paragraph 30.1(2)(a) of the Act, IO No. 2 will remain in effect for 14 days, unless it's approved by the Governor in Council, in which case it would remain in effect for up to one year.

Objective

IO No. 2 supports Canada's ongoing focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians. It contributes to securing Canada's medical device supply chain by

Background

COVID-19

COVID-19 is a new disease never before seen in humans. It is an infectious respiratory disease caused by a strain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it may cause pneumonia, severe acute respiratory syndrome, kidney failure and death.

The disease was first detected in Wuhan, China, in December 2019. The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. Originally seen to be a local outbreak, COVID-19 has now affected the majority of countries around the globe. According to the COVID-19 Dashboard by the Center for Systems Science and Engineering at Johns Hopkins University, there are now more than 106 million cases, and over 2 million people have lost their lives. According to the outbreak update from the Government of Canada, the number of confirmed cases in Canada as of February 8, 2021, has exceeded 800 000. However, the situation continues to evolve and change.

From the outset, the COVID-19 pandemic has created challenges in global supply chains, including an unprecedented demand for certain medical devices. Medical device manufacturers and importers adapted quickly to meet demands for COVID-19 devices. New manufacturers also stepped in to create additional capacity.

Global efforts are focused on identifying cases and preventing further spread.

Government of Canada's response

The health and safety of Canadians is the Government of Canada's top priority during the COVID-19 pandemic. The Government therefore took action to provide a faster way to authorize the importation and sale in Canada of medical devices that are used to diagnose, treat, mitigate or prevent COVID-19.

The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 has been effective. For instance, over 500 authorizations for COVID-19 medical devices have been issued, including for testing devices and medical devices other than testing devices, such as personal protective equipment. This authorization pathway for COVID-19 medical devices has also helped to secure Canada's medical device supply chain. It did so by facilitating continued expedited access to safe and effective COVID-19 devices for health care workers and other Canadians.

As the pandemic evolves, the Government of Canada continues to evaluate Canada's medical device supply. Without widespread immunization at this time, one of the best options for controlling the spread of the virus and managing its risks is to continue to enhance access to COVID-19 medical devices.

The tools and flexibilities used to authorize the importation and sale of COVID-19 medical devices from the previous interim order are the most effective means for providing an expedited pathway for COVID-19 devices. They also help to facilitate people's access to the devices they need.

Implications

Requirements carried over from the previous interim order

As was the case under the previous interim order, IO No. 2 provides for an expedited authorization pathway for COVID-19 medical devices. This contributes to ensuring Canadians have continued access to COVID-19 medical devices.

IO No. 2 continues to apply to all classes of medical devices and provides three authorization mechanisms:

IO No. 2 still allows the Minister to determine the level of evidence required to demonstrate the safety and effectiveness of devices authorized through the interim order, in light of the urgent public health need. This new interim order continues to also

Further, any applications that are outstanding when the previous interim order expires will still be considered under IO No. 2.

All authorized COVID-19 devices are subject to post-market requirements. These include incident reporting, reporting of a voluntary recall and record-keeping requirements related to distribution.

The Minister also maintains the ability, at any time, to

Health Canada will continue to monitor the safety and effectiveness of authorized COVID-19 devices. This includes taking immediate action, such as cancelling authorizations if required, to protect people's health and safety.

Manufacturers of medical devices authorized under the Interim Order will not be subject to evaluation, amendment and right-to-sell fees.

New requirements

MDELs

IO No. 2 requires importers and distributors of all COVID-19 devices to

Importers and distributors will

This new MDEL requirement will allow Health Canada to better monitor the medical device supply chain.

Under the Medical Devices Regulations, Health Canada inspects the operations of MDEL holders for various activities. This includes verifying that MDEL holders have procedures in place to maintain records and handle complaints. Inspections are important to verify that MDEL holders can

A six-month transition period for affected stakeholders to comply with the new requirement accomplishes two things. It

Bilingual labelling

Manufacturers, importers and distributors of all COVID-19 medical devices must comply with the labelling content provisions set out in the previous interim order. Now, they must also comply with provisions similar to those of the Medical Devices Regulations to have bilingual labelling under certain circumstances.

This requirement is expected to have minimal impact on existing devices with Interim Order authorizations. Guidance relating to the previous interim order outlined that any medical device authorized under the interim order should have bilingual labelling available as soon as possible.

All manufacturers have six months from when IO No. 2 takes effect to comply with the bilingual labelling requirements. Importers, distributors and retailers have another three months to deplete current stock of medical devices that are labelled in accordance with the previous interim order.

Medical devices authorized under the previous interim order or IO No. 2 must be brought into compliance with the new requirements within the allotted transition period. Those that do not will no longer be able to be imported into or sold in Canada.

Consultation

Health Canada launched a targeted email consultation addressing the proposed regulatory approach for IO No. 2. The consultation was sent to 9 000 stakeholders, including

Health Canada received 72 stakeholder responses in total.

The email-based consultation was chosen in lieu of a broader consultation to target those who were affected by the Interim Order. As IO No. 2 relates to authorizing products for import or sale, a decision was made to focus the consultation on the manufacturers, importers and distributors who are directly impacted by the Interim Order. These included the industry stakeholders listed above, federal government departments, provinces and territories. It was also decided that a targeted consultation with impacted stakeholders would be an efficient mechanism for seeking feedback on IO No. 2, given the urgent need to ensure continued access to devices.

Furthermore, the previous interim order had been in place and public for nearly nine months before the email consultation began. Health Canada had not received any feedback from outside these groups about the Interim Order process. The overall approach was also being largely maintained.

Some of the stakeholder responses about the Interim Order focused on operational issues, such as approval timelines, rather than the proposed regulatory approach, which was the focus of the consultation. Health Canada regularly reviews the Interim Order application and review process in order to gain efficiencies and improve timelines. Health Canada will consider these comments in its next review.

Of the comments concerning the policy approaches in IO No. 2, respondents were generally supportive of the provisions. Some stakeholders gave specific reasons for their support of the previous interim order, such as

These provisions are being carried over as part of IO No. 2.

Respondents also provided feedback on the IO No. 2 new requirements for bilingual labelling and MDELs. Most respondents did not express significant concerns about meeting these new requirements in IO No. 2. However, some international manufacturers were concerned about the new bilingual labelling requirements. Most respondents also indicated that they intend to continue marketing their COVID-19 devices after the pandemic is over.

The bilingual labelling and MDEL requirements are justified given the need for oversight over industry and the fact that these requirements exist under the Medical Devices Regulations. To mitigate these concerns, Health Canada is including transition periods to help offset the burden on industry.

Health Canada also held two stakeholder webinars and presented at the Regulatory MedTech Conference. Health Canada used these sessions to explain the proposed regulatory approach to renewing the flexibilities introduced in the previous interim order. Stakeholder feedback during these sessions was consistent with the feedback received in the email consultation. Generally, participants support Health Canada's approach and significant concerns were not raised. The questions raised focused mainly on the same operational issues as those expressed in the written submissions.

Based on the stakeholder feedback from both the email consultation and webinars, no further changes were made to IO No. 2.

Health Canada also

PHAC expressed support for the interim order flexibilities to be continued. The provinces, territories and other federal government departments did not have any reservations.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca

DEPARTMENT OF HEALTH

HAZARDOUS MATERIALS INFORMATION REVIEW ACT

Filing of claims for exemption

A supplier can file a claim for exemption under the Hazardous Materials Information Review Act (HMIRA) with Health Canada from having to disclose information under the Hazardous Products Act (HPA) and Hazardous Products Regulations (HPR) that they consider to be confidential business information (CBI) on a safety data sheet (SDS) or label associated with a hazardous product.

An employer can also file a claim for exemption under the HMIRA with Health Canada from having to disclose information under the Canada Labour Code or the provisions of the Accord Act that they consider to be CBI on an SDS or label associated with a hazardous product.

Notice is hereby given of the filing of claims for exemption under the HMIRA listed in the table below.

Lynn Berndt-Weis
Director
Workplace Hazardous Materials Bureau
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch

Claimant Product Identifier Subject of the Claim for Exemption Registry Number
Momentive Performance Materials Niax* silicone Y-10762 C.i. and C. of one ingredient 03401328
Afton Chemical Corporation HiTEC® 3471S Performance Additive C.i. of one ingredient 03401547
Afton Chemical Corporation HiTEC® 475 Performance Additive C.i. of one ingredient 03401548
ChampionX Canada ULC PARA11518W C.i. and C. of three ingredients 03401549
Baker Hughes Canada Company FORSA™ SCW4485 SCALE INHIBITOR C.i. of two ingredients 03402220
Novamen Inc. NovaSol HD C.i. and C. of four ingredients 03402221
Innospec Fuel Specialties LLC DCI-11 Plus ClearTrak™ C.i. and C. of one ingredient 03402543
Nalco Canada ULC EC5022A C.i. of one ingredient 03403146
BASF Canada Inc. Joncryl 1982 C.i. and C. of one ingredient 03403147
BASF Canada Inc. Joncryl 1984 C.i. and C. of one ingredient 03403148
BASF Canada Inc. Joncryl 2980 C.i. and C. of one ingredient 03403149
BASF Canada Inc. Joncryl 2981 C.i. and C. of one ingredient 03403150
BASF Canada Inc. Joncryl 541 C.i. and C. of one ingredient 03403151
BASF Canada Inc. Joncryl 8383-A C.i. and C. of one ingredient 03403152
BASF Canada Inc. Joncryl FLX 5060 C.i. and C. of one ingredient 03403153
SUEZ Water Technologies & Solutions Canada Spec-Aid BIO9101ULS C.i. and C. of one ingredient 03403251
FUJIFILM Electronic Materials, U.S.A., Inc. OiR 674-09 C.i. of one ingredient 03403252
FUJIFILM Electronic Materials, U.S.A., Inc. OiR 674-11 C.i. of one ingredient 03403253
FUJIFILM Electronic Materials, U.S.A., Inc. OiR 674-17 C.i. of one ingredient 03403254
Magnaflux ZL-67 C.i. and C. of two ingredients 03403957
Innospec Fuel Specialties LLC DCI-11 Plus lf1 C.i. and C. of two ingredients 03403958

Note: C.i. = chemical identity and C. = concentration

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

March 10, 2021

Diane Bélanger
Official Documents Registrar

DEPARTMENT OF TRANSPORT

AERONAUTICS ACT

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 23

Whereas the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 23 is required to deal with a significant risk, direct or indirect, to aviation safety or the safety of the public;

Whereas the provisions of the annexed Order may be contained in a regulation made pursuant to sections 4.71footnote c and 4.9footnote d, paragraphs 7.6(1)(a)footnote e and (b)footnote f and section 7.7footnote g of the Aeronautics Actfootnote h;

Whereas, pursuant to subsection 6.41(1.1)footnote i of the Aeronautics Actfootnote h, the Minister of Transport authorized the Deputy Minister of Transport to make an interim order that contains any provision that may be contained in a regulation made under Part I of that Act to deal with a significant risk, direct or indirect, to aviation safety or the safety of the public;

And whereas, pursuant to subsection 6.41(1.2)footnote i of that Act, the Deputy Minister of Transport has consulted with the persons and organizations that that Minister considers appropriate in the circumstances before making the annexed Order;

Therefore, the Deputy Minister of Transport, pursuant to subsection 6.41(1.1)footnote h of the Aeronautics Actfootnote i, makes the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 23.

Ottawa, March 4, 2021

Michael Keenan
Deputy Minister of Transport

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 23

Interpretation

Definitions

1 (1) The following definitions apply in this Interim Order.

aerodrome security personnel
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (personnel de sûreté de l’aérodrome)
air carrier
means any person who operates a commercial air service under Subpart 1, 3, 4 or 5 of Part VII of the Regulations. (transporteur aérien)
checked baggage
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (bagages enregistrés)
COVID-19
means the coronavirus disease 2019. (COVID-19)
COVID-19 molecular test
means a COVID-19 screening or diagnostic test carried out by an accredited laboratory, including a test performed using the method of polymerase chain reaction (PCR) or reverse transcription loop-mediated isothermal amplification (RT-LAMP). (essai moléculaire relatif à la COVID-19 )
document of entitlement
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (document d’autorisation)
elevated temperature
means a temperature within the range set out in the standards. (température élevée)
foreign national
means a person who is not a Canadian citizen or a permanent resident and includes a stateless person. (étranger)
non-passenger screening checkpoint
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (point de contrôle des non-passagers)
passenger screening checkpoint
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (point de contrôle des passagers)
peace officer
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (agent de la paix)
Regulations
means the Canadian Aviation Regulations. (Règlement)
restricted area
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (zone réglementée)
screening officer
has the same meaning as in section 2 of the Canadian Air Transport Security Authority Act. (agent de contrôle)
standards
means the document entitled the Transport Canada Temperature Screening Standards, published by the Minister, as amended from time to time. (normes)

Interpretation

(2) Unless the context requires otherwise, all other words and expressions used in this Interim Order have the same meaning as in the Regulations.

Conflict

(3) In the event of a conflict between this Interim Order and the Regulations or the Canadian Aviation Security Regulations, 2012, the Interim Order prevails.

Definition of face mask

(4) For the purposes of this Interim Order, a face mask means any mask, including a non-medical mask that meets all of the following requirements:

Face masks — lip reading

(5) Despite paragraph (4)(a), the portion of a face mask in front of a wearer's lips may be made of transparent material that permits lip reading if

Notification

Federal, provincial and territorial measures

2 (1) A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must notify every person boarding the aircraft for the flight that they may be subject to measures to prevent the spread of COVID-19 taken by the provincial or territorial government with jurisdiction where the destination aerodrome for that flight is located or by the federal government.

Suitable quarantine plan and prepaid accommodation

(2) A private operator or air carrier operating a flight to Canada departing from any other country must notify every person before the person boards the aircraft for the flight that they may be required, under an order made under section 58 of the Quarantine Act, to provide, before boarding the aircraft, to the Minister of Health by the electronic means specified by that Minister a suitable quarantine plan and evidence of prepaid accommodation arrangements that enables them to remain in quarantine at a government-authorized accommodation for a three-day period that begins on the day on which they enter Canada or, if the person is not required under that order to provide the plan and the evidence, their contact information. The private operator or air carrier must also notify every person that they may be liable to a fine, if this requirement applies to them and they fail to comply with it.

False declarations

(3) A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must notify every person boarding the aircraft for the flight that they may be liable to a monetary penalty if they provide a confirmation referred to in subsection 3(1) that they know to be false or misleading.

Confirmation

Federal, provincial and territorial measures

3 (1) Before boarding an aircraft for a flight between two points in Canada or a flight to Canada departing from any other country, every person must confirm to the private operator or air carrier operating the flight that they understand that they may be subject to a measure to prevent the spread of COVID-19 taken by the provincial or territorial government with jurisdiction where the destination aerodrome for that flight is located or by the federal government.

False declaration

(2) A person must not provide a confirmation referred to in subsection (1) that they know to be false or misleading.

Exception

(3) A competent adult may provide a confirmation referred to in subsection (1) on behalf of a person who is not a competent adult.

Prohibition

4 A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must not permit a person to board the aircraft for the flight if the person is a competent adult and does not provide a confirmation that they are required to provide under subsection 3(1).

Foreign Nationals

Prohibition

5 A private operator or air carrier must not permit a foreign national to board an aircraft for a flight that the private operator or air carrier operates to Canada departing from any other country.

Exception

6 Section 5 does not apply to a foreign national who is permitted to enter Canada under an order made under section 58 of the Quarantine Act.

Health Check

Non-application

7 Sections 8 to 10 do not apply to either of the following persons:

Health check

8 (1) A private operator or air carrier must conduct a health check of every person boarding an aircraft for a flight that the private operator or air carrier operates by asking questions to verify whether they exhibit any of the following symptoms:

Notification

(2) A private operator or air carrier must notify every person boarding an aircraft for a flight that the private operator or air carrier operates that the person may not be permitted to board the aircraft if

Confirmation

(3) Every person boarding an aircraft for a flight that a private operator or air carrier operates must confirm to the private operator or air carrier that none of the following situations apply to them:

False declaration — obligation of private operator or air carrier

(4) The private operator or air carrier must advise every person that they may be liable to a monetary penalty if they provide answers, with respect to the health check or a confirmation, that they know to be false or misleading.

False declaration — obligations of person

(5) A person who, under subsections (1) and (3), is subjected to a health check and is required to provide a confirmation must

Exception

(6) A competent adult may answer all questions and provide a confirmation on behalf of a person who is not a competent adult and who, under subsections (1) and (3), is subjected to a health check and is required to give a confirmation.

Observations — private operator or air carrier

(7) During the boarding process for a flight that the private operator or air carrier operates, the private operator or air carrier must observe whether any person boarding the aircraft is exhibiting any symptoms referred to in subsection (1).

Prohibition

9 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if

Period of 14 days

10 A person who is not permitted to board an aircraft under section 9 is not permitted to board another aircraft for a period of 14 days after the refusal, unless they provide a medical certificate certifying that any symptoms referred to in subsection 8(1) that they are exhibiting are not related to COVID-19.

COVID-19 Molecular Test — Flights to Canada

Application

10.1 (1) Sections 10.2 to 10.7 apply to a private operator or air carrier operating a flight to Canada departing from any other country and to every person boarding an aircraft for such a flight.

Non-application

(2) Sections 10.2 to 10.7 do not apply to persons who are not required under an order made under section 58 of the Quarantine Act to provide evidence that they received a result for a COVID-19 molecular test.

Notification

10.2 A private operator or air carrier must notify every person who intends to board an aircraft for a flight that the private operator or air carrier operates that the person may not be permitted to board the aircraft if they are unable to provide evidence that they received a result for a COVID-19 molecular test.

Result

10.3 Before boarding an aircraft for a flight, every person must provide to the private operator or air carrier operating the flight evidence that they received either

Evidence — elements

10.4 Evidence of a result for a COVID-19 molecular test must include

False or misleading evidence

10.5 A person must not provide evidence of a result for a COVID-19 molecular test that they know to be false or misleading.

Notice to Minister

10.6 A private operator or air carrier that has reason to believe that a person has provided evidence of a result for a COVID-19 molecular test that is likely to be false or misleading must notify the Minister as soon as feasible of the person's name and contact information and the date and number of the person's flight.

Prohibition

10.7 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if the person does not provide evidence that they received a result for a COVID-19 molecular test in accordance with the requirements set out in section 10.3.

Temperature Screening — Flights to Canada

Application

11 (1) Sections 12 to 19 apply to an air carrier operating a flight to Canada departing from any other country and to every person boarding an aircraft for such a flight.

Non-application

(2) Sections 12 to 19 do not apply to either of the following persons:

Non-application — crew member

(3) Sections 12 to 15 do not apply to a crew member who underwent a temperature screening under section 22 for the duration of the shift during which the temperature screening was conducted.

Requirement

12 (1) Subject to subsection 19(2), an air carrier must conduct a temperature screening of every person boarding an aircraft for a flight that the air carrier operates. The screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Second screening

(2) The air carrier must conduct a second temperature screening if the first temperature screening indicates that the person has an elevated temperature. The second temperature screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Notification

13 (1) An air carrier must notify every person boarding an aircraft for a flight that the air carrier operates that they may not be permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening conducted under subsection 12(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Confirmation

(2) Before boarding an aircraft for a flight, every person must confirm to the air carrier operating the flight that they understand that they may not be permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening conducted under subsection 12(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — elevated temperature

14 (1) If the temperature screening conducted under subsection 12(2) indicates that the person has an elevated temperature, the air carrier must

Prohibition — refusal

(2) If a person refuses to be subjected to a temperature screening, the air carrier must not permit the person to board the aircraft.

Period of 14 days

15 A person who is not permitted to board an aircraft under section 14 is not permitted to board another aircraft for a flight to Canada for a period of 14 days after the refusal, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Requirement — equipment

16 An air carrier must calibrate and maintain the equipment that it uses to conduct temperature screenings under subsection 12(2) to ensure that the equipment is in proper operating condition.

Requirement — training

17 An air carrier must ensure that the person using the equipment to conduct temperature screenings under subsection 12(2) has been trained to operate that equipment and interpret the data that it produces.

Record keeping — equipment

18 (1) An air carrier must keep a record of the following information in respect of each flight it operates:

Record keeping — training

(2) An air carrier must keep a record of the name of every person who has received training under section 17, as well as the contents of the training.

Retention period

(3) The air carrier must

Ministerial request

(4) The air carrier must make the records referred to in subsections (1) and (2) available to the Minister on request.

Definition of authorized person

19 (1) For the purposes of this section, authorized person means a person authorized by a competent authority to conduct temperature screenings at an aerodrome located outside of Canada.

Exception

(2) An air carrier may rely on an authorized person to conduct the temperature screening under subsection 12(1), in which case subsection 12(2) and sections 13, 14, and 16 to 18 do not apply to that air carrier.

Notification

(3) The air carrier must notify every person boarding the aircraft for the flight that they are not permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Period of 14 days

(4) If the temperature screening indicates that a person has an elevated temperature, that person is not permitted to board an aircraft for a flight to Canada for a period of 14 days after the temperature screening, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Equipment

(5) The air carrier must ensure that the equipment used to conduct those temperature screenings is calibrated and maintained so that the equipment is in proper operating condition.

Temperature Screening — Aerodromes in Canada

Definition of screening authority

20 (1) For the purposes of this section and sections 21 to 31, screening authority has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012.

Application

(2) Sections 21 to 31 apply to all of the following persons:

Non-application

(3) Sections 21 to 31 do not apply to any of the following persons:

Requirement

21 A person entering a restricted area within an air terminal building from a non-restricted area within the air terminal building must do so at a passenger screening checkpoint or non-passenger screening checkpoint.

Requirement — temperature screening

22 (1) Subject to subsection (3), a screening authority must conduct a temperature screening of every person who presents themselves at a passenger screening checkpoint or non-passenger screening checkpoint within an air terminal building for the purpose of entering a restricted area from a non-restricted area and of every person undergoing a screening at a non-passenger screening checkpoint outside an air terminal building. The screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Second screening

(2) Following a rest period of 10 minutes, the screening authority must conduct a second temperature screening if the first temperature screening indicates that the person has an elevated temperature. The second temperature screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Exception

(3) If the temperature screening of a person, other than a passenger, who presents themselves at a passenger screening checkpoint or non-passenger screening checkpoint within an air terminal building for the purpose of entering a restricted area from a non-restricted area, or of a person who is undergoing a screening at a non-passenger screening checkpoint outside an air terminal building, indicates that the person does not have an elevated temperature, the screening authority is not required to conduct any further temperature screenings of that person for the duration of the day during which the temperature screening was conducted.

Notification — consequence of elevated temperature

23 (1) An air carrier must notify every person, other than a crew member, who intends to board an aircraft for a flight that the air carrier operates that they may not be permitted to board an aircraft for a flight originating in Canada and that they must not enter a restricted area at any aerodrome in Canada for a period of 14 days if the temperature screening conducted under subsection 22(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Confirmation — consequence of elevated temperature

(2) Before passing beyond a passenger screening checkpoint to board an aircraft for a flight, every person other than a crew member must confirm to the air carrier operating the flight that they understand that they may not be permitted to board an aircraft for a flight originating in Canada and that they must not enter a restricted area at any aerodrome in Canada for a period of 14 days if the temperature screening conducted under subsection 22(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — elevated temperature

24 (1) If the temperature screening conducted under subsection 22(2) indicates that the person has an elevated temperature, the screening authority must

Prohibition — refusal

(2) If a person refuses to be subjected to a temperature screening, the screening authority must deny them entry to the restricted area.

Period of 14 days

25 A person who is denied entry to the restricted area under section 24 is not permitted to enter a restricted area at any aerodrome in Canada for a period of 14 days after the denial, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Denial — person intending to board aircraft

26 (1) If, under section 24, a screening authority denies entry to a restricted area to a person who intends to board an aircraft for a flight, other than a crew member, the screening authority must, for the purpose of paragraph 26(4)(a), notify the air carrier operating the flight that that person has been denied entry to the restricted area and provide the person's name and flight number to the air carrier.

Denial — person not intending to board aircraft

(2) If, under section 24, a screening authority denies entry to a restricted area to a person who does not intend to board an aircraft for a flight, the screening authority must, for the purpose of subsection 26(5), provide the following information to the operator of the aerodrome:

Denial — crew member

(3) If, under section 24, a screening authority denies entry to a restricted area to a crew member, the screening authority must provide the information referred to in subsection (2) to the air carrier for the purpose of allowing the air carrier to assign a replacement crew member, if necessary.

Denial — air carrier requirements

(4) An air carrier that has been notified under subsection (1) must

Denial — aerodrome operator requirement

(5) The operator of an aerodrome that has been notified under subsection (2) must suspend the person's restricted area entry privileges for a period of 14 days after the person was denied entry to the restricted area, unless the person provides a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — restricted area

(6) If, under section 24, a screening authority denies entry to a restricted area to a crew member or to a person who does not intend to board an aircraft for a flight, the crew member or that person must not present themselves at a passenger screening checkpoint or non-passenger screening checkpoint at any aerodrome for the purpose of entering a restricted area for a period of 14 days after the denial, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Requirement — equipment

27 A screening authority must ensure that the equipment that it uses to conduct temperature screenings under section 22 is calibrated and maintained so that the equipment is in proper operating condition.

Requirement — training

28 A screening authority must ensure that the person using the equipment to conduct temperature screenings under section 22 has been trained to operate that equipment and interpret the data that it produces.

Record keeping — equipment

29 (1) A screening authority must keep a record of the following information with respect to any temperature screening it conducts:

Record keeping — training

(2) The screening authority must keep a record of the name of every person who has received training under section 28, as well as the contents of the training.

Retention

(3) The screening authority must

Ministerial request

(4) The screening authority must make the records referred to in subsections (1) and (2) available to the Minister on request.

Temperature screening facilities

30 The operator of an aerodrome must make facilities available for temperature screening that are accessible without having to enter a restricted area.

Requirement — air carrier representative

31 An air carrier must ensure that the screening authority at the aerodrome has been provided with the name and telephone number of the on-duty representative of the air carrier for the purpose of facilitating the return of checked baggage to persons who are denied entry to a restricted area under section 24.

Face Masks

Non-application

32 (1) Sections 33 to 38 do not apply to any of the following persons:

Face mask readily available

(2) An adult responsible for a child who is at least two years of age but less than six years of age must ensure that a face mask is readily available to the child before boarding an aircraft for a flight.

Wearing of face mask

(3) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under section 35 and complies with any instructions given by a gate agent under section 36 if the child

Notification

33 A private operator or air carrier must notify every person who intends to board an aircraft for a flight that the private operator or air carrier operates that the person must

Obligation to possess face mask

34 Every person who is at least six years of age must be in possession of a face mask before boarding an aircraft for a flight.

Wearing of face mask — persons

35 (1) Subject to subsections (2) to (3), a private operator or air carrier must require a person to wear a face mask at all times during the boarding process and during a flight that the private operator or air carrier operates.

Exceptions — person

(2) Subsection (1) does not apply

Exceptions — flight deck

(3) Subsection (1) does not apply to any of the following persons when they are on the flight deck:

Compliance

36 A person must comply with any instructions given by a gate agent, a member of the aerodrome security personnel or a crew member with respect to wearing a face mask.

Prohibition — private operator or air carrier

37 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if

Refusal to comply

38 (1) If, during a flight that a private operator or air carrier operates, a person refuses to comply with an instruction given by a crew member with respect to wearing a face mask, the private operator or air carrier must

Retention period

(2) The private operator or air carrier must retain the record referred to in paragraph (1)(a) for a period of at least 12 months after the day of the flight.

Ministerial request

(3) The private operator or air carrier must make the records referred to in paragraph (1)(a) available to the Minister on request.

Wearing of face mask — crew member

39 (1) Subject to subsections (2) to (3), a private operator or air carrier must require a crew member to wear a face mask at all times during the boarding process and during a flight that the private operator or air carrier operates.

Exceptions — crew member

(2) Subsection (1) does not apply

Exception — flight deck

(3) Subsection (1) does not apply to a crew member who is a flight crew member when they are on the flight deck.

Wearing of face mask — gate agent

40 (1) Subject to subsections (2) and (3), a private operator or air carrier must require a gate agent to wear a face mask during the boarding process for a flight that the private operator or air carrier operates.

Exceptions

(2) Subsection (1) does not apply

Exception — physical barrier

(3) During the boarding process, subsection (1) does not apply to a gate agent if the gate agent is separated from any other person by a physical barrier that allows the gate agent and the other person to interact and reduces the risk of exposure to COVID-19.

Deplaning

Non-application

41 (1) Section 42 does not apply to any of the following persons:

Wearing of face mask

(2) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under section 42 if the child

Wearing of face mask — person

42 A person who is on board an aircraft must wear a face mask at all times from the moment the doors of the aircraft are opened until the person enters the air terminal building, including by a passenger loading bridge.

Screening Authority

Definition of screening authority

43 (1) For the purposes of sections 44 and 47, screening authority means a person responsible for the screening of persons and goods at an aerodrome set out in the schedule to the CATSA Aerodrome Designation Regulations or at any other place designated by the Minister under subsection 6(1.1) of the Canadian Air Transport Security Authority Act.

Non-application

(2) Sections 44 to 47 do not apply to any of the following persons:

Wearing of face mask

(3) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under subsection 44(2) and removes it when required by a screening officer to do so under subsection 44(3) if the child

Requirement — passenger screening checkpoint

44 (1) A screening authority must notify a person who is subject to screening at a passenger screening checkpoint that they must wear a face mask at all times during screening.

Wearing of face mask — person

(2) Subject to subsection (3), a person who is the subject of screening referred to in subsection (1) must wear a face mask at all times during screening.

Requirement to remove face mask

(3) A person who is required by a screening officer to remove their face mask during screening must do so.

Wearing of face mask — screening officer

(4) A screening officer must wear a face mask at a passenger screening checkpoint when conducting the screening of a person if, during the screening, the screening officer is two metres or less from the person being screened.

Requirement — non-passenger screening checkpoint

45 (1) A person who presents themselves at a non-passenger screening checkpoint to enter into a restricted area must wear a face mask at all times.

Wearing of face mask — screening officer

(2) Subject to subsection (3), a screening officer must wear a face mask at all times at a non-passenger screening checkpoint.

Exceptions

(3) Subsection (2) does not apply

Exception — physical barrier

46 Sections 44 and 45 do not apply to a person, including a screening officer, if the person is two metres or less from another person and both persons are separated by a physical barrier that allows them to interact and reduces the risk of exposure to COVID-19.

Prohibition — passenger screening checkpoint

47 (1) A screening authority must not permit a person who has been notified to wear a face mask and refuses to do so to pass beyond a passenger screening checkpoint into a restricted area.

Prohibition — non-passenger screening checkpoint

(2) A screening authority must not permit a person who refuses to wear a face mask to pass beyond a non-passenger screening checkpoint into a restricted area.

Designated Provisions

Designation

48 (1) The provisions of this Interim Order set out in column 1 of Schedule 2 are designated as provisions the contravention of which may be dealt with under and in accordance with the procedure set out in sections 7.7 to 8.2 of the Act.

Maximum amounts

(2) The amounts set out in column 2 of Schedule 2 are the maximum amounts of the penalty payable in respect of a contravention of the designated provisions set out in column 1.

Notice

(3) A notice referred to in subsection 7.7(1) of the Act must be in writing and must specify

Repeal

49 The Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 22, made on February 19, 2021, is repealed.

SCHEDULE 1

(Subsection 20(2))

Aerodromes
Name ICAO Location Indicator
Calgary International Airport CYYC
Edmonton International Airport CYEG
Halifax / Robert L. Stanfield International Airport CYHZ
Kelowna International Airport CYLW
Montréal / Pierre Elliott Trudeau International Airport CYUL
Ottawa / Macdonald-Cartier International Airport CYOW
Québec / Jean Lesage International Airport CYQB
Regina International Airport CYQR
Saskatoon / John G. Diefenbaker International Airport CYXE
St. John's International Airport CYYT
Toronto / Billy Bishop Toronto City Airport CYTZ
Toronto / Lester B. Pearson International Airport CYYZ
Vancouver International Airport CYVR
Victoria International Airport CYYJ
Winnipeg / James Armstrong Richardson International Airport CYWG

SCHEDULE 2

(Subsections 48(1) and (2))

Designated Provisions

Column 1

Designated Provision

Column 2

Maximum Amount of Penalty ($)
Individual Corporation
Subsection 2(1) 5,000 25,000
Subsection 2(2) 5,000 25,000
Subsection 2(3) 5,000 25,000
Subsection 3(1) 5,000  
Subsection 3(2) 5,000  
Section 4 5,000 25,000
Section 5 5,000 25,000
Subsection 8(1) 5,000 25,000
Subsection 8(2) 5,000 25,000
Subsection 8(3) 5,000  
Subsection 8(4) 5,000 25,000
Subsection 8(5) 5,000  
Subsection 8(7) 5,000 25,000
Section 9 5,000 25,000
Section 10 5,000  
Section 10.2 5,000 25,000
Section 10.3 5,000  
Section 10.5 5,000  
Section 10.6 5,000 25,000
Section 10.7 5,000 25,000
Subsection 12(1)   25,000
Subsection 12(2)   25,000
Subsection 13(1)   25,000
Subsection 13(2) 5,000  
Subsection 14(1)   25,000
Subsection 14(2)   25,000
Section 15 5,000  
Section 16   25,000
Section 17   25,000
Subsection 18(1)   25,000
Subsection 18(2)   25,000
Subsection 18(3)   25,000
Subsection 18(4)   25,000
Subsection 19(3)   25,000
Subsection 19(4) 5,000  
Subsection 19(5)   25,000
Section 21 5,000  
Subsection 22(1)   25,000
Subsection 22(2)   25,000
Subsection 23(1)   25,000
Subsection 23(2) 5,000  
Subsection 24(1)   25,000
Subsection 24(2)   25,000
Section 25 5,000  
Subsection 26(1)   25,000
Subsection 26(2)   25,000
Subsection 26(3)   25,000
Subsection 26(4)   25,000
Subsection 26(5)   25,000
Subsection 26(6) 5,000  
Section 27   25,000
Section 28   25,000
Subsection 29(1)   25,000
Subsection 29(2)   25,000
Subsection 29(3)   25,000
Subsection 29(4)   25,000
Section 30   25,000
Section 31   25,000
Subsection 32(2) 5,000  
Subsection 32(3) 5,000  
Section 33 5,000 25,000
Section 34 5,000  
Subsection 35(1) 5,000 25,000
Section 36 5,000  
Section 37 5,000 25,000
Subsection 38(1) 5,000 25,000
Subsection 38(2) 5,000 25,000
Subsection 38(3) 5,000 25,000
Subsection 39(1) 5,000 25,000
Subsection 40(1) 5,000 25,000
Subsection 41(2) 5,000  
Section 42 5,000  
Subsection 43(3) 5,000  
Subsection 44(1)   25,000
Subsection 44(2) 5,000  
Subsection 44(3) 5,000  
Subsection 44(4) 5,000  
Subsection 45(1) 5,000  
Subsection 45(2) 5,000  
Subsection 47(1)   25,000
Subsection 47(2)   25,000

GLOBAL AFFAIRS CANADA

Consultations on Canada's possible accession to the Digital Economy Partnership Agreement

On March 19, 2021, Canada launched consultations on Canada's future potential accession to the Digital Economy Partnership Agreement (DEPA) between Chile, New Zealand, and Singapore (DEPA Parties).

Background

The DEPA was signed by Chile, New Zealand and Singapore on June 12, 2020, and officially entered into force on January 7, 2021, for New Zealand and Singapore. The DEPA is a new type of international trade policy instrument that addresses a range of emerging digital economy issues, including artificial intelligence, digital identities and digital inclusion. It builds upon the digital trade or e-commerce chapters of existing free trade agreements (FTAs), with enhanced commitments related to the facilitation of digital trade and multi-party cooperation on a range of advanced technologies. It is constructed as a “living agreement,” which means that it allows for continual updates and modernization as required.

On December 9, 2020, Canada formally notified the DEPA Parties of its interest in starting exploratory discussions with a view towards possible accession to the DEPA, and on February 16, 2021, Canada launched its first exploratory discussion with the DEPA Parties.

Consultations

The Government of Canada is committed to policies that expand opportunities for more Canadians to compete and succeed in international markets. Global Affairs Canada is soliciting input from interested individuals and stakeholders regarding Canada's possible accession to the DEPA. The Government of Canada is also committed to ensuring that more Canadians have access to the benefits and opportunities that flow from international trade and investment. Therefore, traditionally under-represented groups such as women; micro, small and medium-sized enterprises; and Indigenous peoples are encouraged to provide their input.

The purpose of this consultation is to inform Canada's positions and interests prior to engaging in possible accession negotiations with the DEPA Parties. The Government of Canada is seeking individual and stakeholder views on the DEPA text (PDF) as well as views on how the DEPA could be updated to advance international digital trade and address any trade barriers.

More information on the Government's consultations on Canada's possible accession to the DEPA can be found on the Global Affairs Canada consultation webpage.

All interested parties are invited to submit their written input regarding Canada's possible accession to the DEPA by May 3, 2021. Input can be sent to

DEPA Accession Consultations
Services Trade Policy Division (TMS)
Global Affairs Canada
111 Sussex Drive
Ottawa, Ontario
K1A 0G2
Email: TMSconsultation@international.gc.ca

Please read the privacy statement carefully prior to completing the survey or sending a written submission.

GLOBAL AFFAIRS CANADA

Notice of intent to conduct impact assessments of the modernization of the Canada-Ukraine Free Trade Agreement

The Canada-Ukraine Free Trade Agreement (CUFTA), which entered into force on August 1, 2017, represents an important milestone in the Canada-Ukraine bilateral relationship. While CUFTA is a comprehensive free trade agreement, it does not include obligations on services and investment, nor provisions to reflect all aspects of Canada's current inclusive approach to trade.

In July 2019, Prime Minister Trudeau announced a commitment to expand and modernize CUFTA. Modernization of CUFTA provides an opportunity to increase the Agreement's benefits for Canadians by further diversifying and expanding Canada's preferential access to Ukraine, while seeking new provisions to advance Canada's inclusive approach to trade, such as provisions for trade and gender, small and medium-sized enterprises, and trade and Indigenous peoples. In February 2020, the Government launched public consultations to seek the views of Canadians on the scope of the potential modernization of CUFTA. Overall, Canadians conveyed their support in strengthening bilateral relations with Ukraine. A report summarizing the findings was published on the Global Affairs Canada website in May 2020.

In addition to diversifying trade and investment ties with key markets, the Government of Canada is also committed to a sustainable and inclusive global economic recovery in the context of COVID-19, supported by coordinated trade, investment, and environmental policies.

In accordance with the Cabinet Directive on Environmental Assessment of Policy, Plan and Program Proposals, Global Affairs Canada conducts environmental assessments (EAs) for all trade and investment negotiations using a process that requires interdepartmental coordination and public consultation. The objectives of the environmental assessment of a trade agreement are

The government will also examine gender and other diversity considerations through a gender-based analysis plus (GBA+) of a modernized CUFTA.

These impact assessments must use an open and inclusive process, and begin at the earliest stages of the decision-making process. In this context, Global Affairs Canada is seeking input from Canadians on the potential impacts of CUFTA modernization on environment, gender and other diversity considerations for Canada. These comments will form the basis for an initial environmental assessment and an initial GBA+, and will help inform Canada's positions during possible modernization negotiations.

The initial environmental assessment will use available qualitative evidence to analyze the likely environmental impacts of a modernized FTA. For more information on the full process, please see Global Affairs Canada's environmental assessments of trade agreements webpage.

The initial GBA+ will include an analysis of the potential effects of the modernized FTA on gender and inclusivity in Canada. For more information on GBA+ analyses of trade negotiations, please see the Trade Policy and GBA+ webpage.

The initial environmental assessment and the summary of the initial GBA+ will be published for comment at a later date.

All interested parties are invited to submit their views on the impact assessments of the possible CUFTA modernization by May 4, 2021. Please be advised that any information received as a result of this consultation will be considered public information, unless explicitly specified otherwise. Contributions can be sent to

Canada-Ukraine FTA Consultations
Global Affairs Canada
125 Sussex Drive, 5th Floor
Ottawa, Ontario
K1A 0G2
Email: CUFTA-Consultations@international.gc.ca

INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA

RADIOCOMMUNICATION ACT

Notice No. DGSO-002-21 — Consultation on Amending CPC-2-0-03, Radiocommunication and Broadcasting Antenna Systems

Intent

The intent of this notice is to announce a consultation process entitled DGSO-002-21, Consultation on Amending CPC-2-0-03, Radiocommunication and Broadcasting Antenna Systems. This consultation process will provide updates to Innovation, Science and Economic Development Canada's (ISED) CPC-2-0-03 — Radiocommunication and Broadcasting Antenna Systems that became effective on July 15, 2014.

Obtaining copies

Copies of this notice and of documents referred to herein are available electronically on ISED's Spectrum Management and Telecommunications website.

Official versions of notices can be viewed on the Canada Gazette website.

March 17, 2021

Marc-André Rochon
Senior Director
Spectrum Management Operations Branch

PRIVY COUNCIL OFFICE

Appointment opportunities

We know that our country is stronger — and our government more effective — when decision-makers reflect Canada's diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.

We are equally committed to providing a healthy workplace that supports one's dignity, self-esteem and the ability to work to one's full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.

The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.

Current opportunities

The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.

Governor in Council appointment opportunities
Position Organization Closing date
Member Atlantic Pilotage Authority Canada  
Commissioner British Columbia Treaty Commission  
Member Buffalo and Fort Erie Public Bridge Authority  
Director Business Development Bank of Canada  
President and Chief Executive Officer Business Development Bank of Canada  
President and Chief Executive Officer Canada Development Investment Corporation  
Commissioner for Employers Canada Employment Insurance Commission  
Director Canada Infrastructure Bank  
President and Chief Executive Officer Canada Lands Company Limited  
Director Canada Mortgage and Housing Corporation  
Member of the Board of Directors Canada Post  
Member Canadian Cultural Property Export Review Board  
Director Canadian Energy Regulator  
Federal Housing Advocate Canadian Human Rights Commission  
Chairperson Canadian Human Rights Tribunal  
Member Canadian Human Rights Tribunal  
Member Canadian Institutes of Health Research  
Chairperson Canadian Museum of History  
Director Canadian Museum of History  
Chairperson Canadian Transportation Agency  
Temporary Member Canadian Transportation Agency  
Director Farm Credit Canada  
Chairperson Federal Public Sector Labour Relations and Employment Board  
Vice-Chairperson Federal Public Sector Labour Relations and Employment Board  
Director Freshwater Fish Marketing Corporation  
Member Great Lakes Pilotage Authority Canada  
Director
(Federal)		 Hamilton-Oshawa Port Authority  
Member, Yukon Historic Sites and Monuments Board of Canada  
Assistant Deputy Chairperson Immigration and Refugee Board of Canada  
Member
(appointment to roster)		 International Trade and International Investment Dispute Settlement Bodies  
Chairperson Laurentian Pilotage Authority Canada  
Director Marine Atlantic Inc.  
Chairperson Military Police Complaints Commission of Canada  
Member Military Police Complaints Commission of Canada  
Member National Arts Centre Corporation  
Member National Seniors Council  
Member Natural Sciences and Engineering Research Council of Canada  
Commissioner and Director Office of the Commissioner of Indigenous Languages  
Superintendent Office of the Superintendent of Financial Institutions Canada  
Member Payments in Lieu of Taxes Dispute Advisory Panel  
Commissioner Roosevelt Campobello International Park Commission  
Member Social Sciences and Humanities Research Council of Canada  
Chairperson Standards Council of Canada  
Registrar Supreme Court of Canada  
Member Telefilm Canada  
Director
(Federal)		 Toronto Port Authority  
Chairperson and Member Transportation Appeal Tribunal of Canada  
Member Transportation Appeal Tribunal of Canada  
Vice-Chairperson Transportation Appeal Tribunal of Canada  
Director
(Federal)		 Trois-Rivières Port Authority