Canada Gazette, Part I, Volume 155, Number 21: GOVERNMENT NOTICES

May 22, 2021

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2021-87-06-02 Amending the Non-domestic Substances List

Whereas, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999footnote a, the Minister of the Environment has added the substances referred to in the annexed Order to the Domestic Substances Listfootnote b;

Therefore, the Minister of the Environment, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999footnote a, makes the annexed Order 2021-87-06-02 Amending the Non-domestic Substances List.

Gatineau, May 6, 2021

Jonathan Wilkinson
Minister of the Environment

Order 2021-87-06-02 Amending the Non-domestic Substances List

Amendment

1 Part I of the Non-domestic Substances Listfootnote 1 is amended by deleting the following:

Coming into Force

2 This Order comes into force on the day on which Order 2021-87-06-01 Amending the Domestic Substances List comes into force.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 20598

Significant New Activity Notice

(Section 110 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 living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 under section 108 of the Canadian Environmental Protection Act, 1999;

Whereas the living organism is not specified on the Domestic Substances List;

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

Therefore, the Minister of the Environment indicates, pursuant to section 110 of the Canadian Environmental Protection Act, 1999, that subsection 106(4) of that act applies with respect to the living organism in accordance with the Annex.

The Honourable Jonathan Wilkinson
Minister of the Environment

ANNEX

Information Requirements

(Section 110 of the Canadian Environmental Protection Act, 1999)

1. In relation to the living organism identified as Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48, a significant new activity is any use of the living organism other than its use

2. Despite section 1, the following do not constitute a significant new activity:

3. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 120 days before the day on which the activity begins:

4. The test data and the test report referred to in paragraph 3(c) must be produced in accordance with the OECD 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 by the Organisation for Economic Co-operation and Development on May 12, 1981, that are current at the time the tests are conducted.

5. The information provided under section 3 is to be assessed within 120 days after the day on which it is received by the Minister of the Environment.

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 110 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48. The Notice is now in force, and it is legally binding. It is therefore mandatory for a person who intends to use the living organism 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 living organism 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 living organism or activities involving the living organism.

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 living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 120 days prior to using the living organism for the significant new activity.

In order to address the environmental concerns, the Notice requires notification in relation to any use of the living organism other than the following:

For example, notification is required if a person plans to use the living organism in bioremediation.

A SNAN is required 120 days before the use of the living organism in a significant new activity.

Activities not subject to the Notice

Uses of the living organism that are regulated under the acts of Parliament listed in Schedule 4 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are excluded from the Notice.

Activities involving the use of the living organism as a research and development organism meeting the conditions set out in the Notice are excluded from the Notice. The term “research and development organism” is defined in subsection 1(1) of the New Substances Notification Regulations (Organisms).

Information to be submitted

The Notice sets out the information that must be provided to the Minister 120 days before the day on which the living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 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 a risk assessment within 120 days after the complete information is received.

The risk assessment of the living organism identified potential concerns associated with use of the organism in activities resulting in its release above certain concentrations to natural aquatic environments, such as water treatment for fish and seafood aquaculture and treatment of wastewater, or to terrestrial environments, such as the reduction of odour in manure intended for use as fertilizer in agricultural fields. This living organism is a bacteria which can potentially cause adverse effects to aquatic and terrestrial invertebrates. The SNAc Notice is issued to gather information to ensure that the living organism will undergo further assessment before significant new activities are undertaken.

The information requirements in the Notice relate to the notified activity, the introduction of the living organism in the environment following the new activity and the effects of the living organism on aquatic and terrestrial invertebrates. Some of the information requirements reference the New Substances Notification Regulations (Organisms).

Additional guidance on preparing a SNAN can be found in section 1.2 of the Guidelines for the Notification and Testing of New Substances: Organisms.

Compliance

When assessing whether or not a living organism 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.

If any information becomes available that reasonably supports the conclusion that the living organism 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 living organism 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 living organism 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 living organism.

Under section 111 of the Act, any person who transfers the physical possession or control of a living organism 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 THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — phenol, 4-chloro-3-methyl (chlorocresol), CAS RN footnote 1 59-50-7 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas chlorocresol is a substance identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;footnote 2

Whereas a summary of the screening assessment conducted on chlorocresol pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that the substance meets one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to recommend to the Administrator in Council that this substance be added to Schedule 1 of the Act.

Notice is furthermore given that the ministers are releasing a proposed risk management approach document for chlorocresol on the Canada.ca (Chemical Substances) website to continue discussions with stakeholders on the manner in which the ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the substance.

Public comment period on the risk management approach

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by email to eccc.substances.eccc@canada.ca or by using the online reporting system available through Environment and Climate Change Canada's Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jonathan Wilkinson
Minister of the Environment

Patty Hajdu
Minister of Health

ANNEX
Summary of the screening assessment of chlorocresol

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of phenol, 4-chloro-3-methyl-, hereinafter referred to as chlorocresol. The Chemical Abstracts Service Registry Number (CAS RN) for chlorocresol is 59-50-7. This substance was identified as a priority for assessment, as it met categorization criteria under subsection 73(1) of CEPA.

Chlorocresol was included in a survey issued pursuant to section 71 of CEPA. There were no reports of manufacture of chlorocresol in Canada above the reporting threshold of 100 kg in 2011. Chlorocresol was reported as being imported into Canada with a total volume in the range of 100 to 1 000 kg for commercial uses as a component in an admixture to concrete. Other uses in Canada include as a component in certain body moisturizer creams/lotions at concentrations up to 0.2%. Chlorocresol was also identified as a non-medicinal ingredient in licensed natural health product creams at concentrations up to 0.2%, as a non-medicinal ingredient in a limited number of pharmaceuticals at concentrations up to 0.1%, and as an active ingredient in one registered pest control product in Canada, which is formulated into concrete admixtures. The sodium salt form of chlorocresol is also registered in two pest control products.

The ecological risk of chlorocresol was characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web – derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances on the basis of their hazard and exposure profiles. Based on the outcome of the ERC analysis, chlorocresol is considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from chlorocresol. It is concluded that chlorocresol does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

On the basis of the low volumes of chlorocresol reported in commerce in Canada, and the low frequency of detection of chlorocresol in Canadian drinking water, wastewater treatment system sludge and indoor air, exposure to the general population to chlorocresol from environmental media is expected to be minimal. Accordingly, risk to human health is considered to be low.

Consumer exposure is not expected from small quantities of chlorocresol used for commercial purposes in certain building or construction materials as a concrete admixture.

In Canada, exposure to chlorocresol may occur through the use of certain body moisturizer creams/lotions, or topical licensed natural health products or pharmaceuticals in which it is present at concentrations up to 0.2%. The highest exposures were estimated for the use of moisturizers when applied to infants (birth to six months old).

The critical health effect for chlorocresol was identified as decreased adrenal gland weights in a chronic exposure study. A comparison of estimated exposure to chlorocresol from its use in body lotions to the critical health effect level resulted in margins of exposure (MOEs) that were considered inadequate to address uncertainties in the health effects and exposure databases.

With respect to short-term dermal exposure to chlorocresol from the use of topical licensed natural health products or pharmaceuticals, a comparison of the estimated exposure to the critical effect level resulted in MOEs that are considered adequate to address uncertainties in the health effects and exposure databases.

Considering all the information presented in this screening assessment, it is concluded that chlorocresol meets the criteria under paragraph 64(c) of CEPA, as it is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Overall conclusion

It is concluded that chlorocresol meets one or more of the criteria set out in section 64 of CEPA.

Chlorocresol has been determined to not meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The screening assessment and the risk management approach document for this substance is available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating 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 c of the Food and Drugs Actfootnote d, makes the annexed Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19.

Ottawa, May 3, 2021

Patricia Hajdu
Minister of Health

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

Interpretation

Definitions

1 The following definitions apply in this Interim Order.

COVID-19
means the coronavirus disease 2019. (COVID-19)
COVID-19 drug
means a drug for human use that is manufactured, sold or represented for use in relation to COVID-19. (drogue utilisée en lien avec la COVID-19)
COVID-19 drug authorization
means an authorization to do any of the following activities:
  • (a) import or sell a COVID-19 drug that is to be tested in a clinical trial; and
  • (b) conduct a clinical trial in respect of such a drug. (autorisation relative à une drogue utilisée en lien avec la COVID-19)
COVID-19 medical device
means a medical device that is manufactured, sold or represented for use in relation to COVID-19. (instrument médical utilisé en lien avec la COVID-19)
COVID-19 medical device authorization
means an authorization to do any of the following activities:
  • (a) import or sell a COVID-19 medical device that is to be tested in a clinical trial; and
  • (b) conduct a clinical trial in respect of such a device. (autorisation relative à un instrument médical utilisé en lien avec la COVID-19)
incident
means any incident involving a COVID-19 medical device that is tested in a clinical trial that
  • (a) is related to a failure of the device or a deterioration in its quality or effectiveness or any inadequacy in its labelling or its directions for use; or
  • (b) has led to the death or a serious deterioration in the state of health of a clinical trial subject, user or other person or could do so were it to recur. (incident)
qualified investigator
means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and who
  • (a) conducts a clinical trial; or
  • (b) in the case of a clinical trial conducted by a team, is the responsible leader of that team. (chercheur compétent)
research ethics board
means a body that is not affiliated with an applicant for a COVID-19 medical device authorization or a COVID-19 drug authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being. (comité d’éthique de la recherche)

Words and expressions

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

Definition of clinical trial

(2) Despite subsection (1), clinical trial has the same meaning as in section 2 of the Act, except as otherwise provided.

Application

Application

3 (1) This Interim Order applies to the importation and sale of a COVID-19 medical device, other than a Class I device, that is to be tested in a clinical trial, to the importation and sale of a COVID-19 drug, other than a drug that is described in Schedule C to the Act, that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device or drug.

Non-application — COVID-19 medical device

(2) The Medical Devices Regulations do not apply to the importation or sale of a COVID-19 medical device that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a device if those activities are authorized by a COVID-19 medical device authorization and the authorization has not been revoked in whole.

Non-application — COVID-19 drug

(3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a drug if those activities are authorized by a COVID-19 drug authorization and the authorization has not been revoked in whole:

PART 1
COVID-19 Medical Devices

Application

4 (1) An application for a COVID-19 medical device authorization must be submitted to the Minister in the form and manner specified by the Minister.

Content

(2) The application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

Class II devices

(3) Despite subsection (2), if the application for the authorization is in respect of a COVID-19 medical device that is a Class II device, the information and material set out in paragraphs (2)(c), (h) to (j), (n) and (q) may be omitted from the application.

Issuance

5 The Minister must issue a COVID-19 medical device authorization if the following requirements are met:

Research ethics board approval

6 A holder of a COVID-19 medical device authorization must not import or sell a COVID-19 medical device for which the authorization has been issued or conduct a clinical trial in respect of such a device unless the holder has obtained, for each clinical trial site, the approval of a research ethics board in respect of the protocol and informed consent form referred to in paragraph 4(2)(p).

Terms and conditions

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

Amendment

8 A holder of a COVID-19 medical device authorization must not import or sell a COVID-19 medical device for which the authorization has been issued or conduct a clinical trial in respect of such a device if the substance of any of the information or material referred to in subsection 4(2) and, if applicable, submitted under subsection 10(1) is significantly different from the substance of the information or material contained in the application, unless

Suspension

9 (1) The Minister may suspend, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if

Reinstatement

(2) The Minister must reinstate a COVID-19 medical device authorization if the holder of the authorization submits to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.

Additional information and material

10 (1) The Minister may request that an applicant for a COVID-19 medical device authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.

Form and manner

(2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.

Discontinuance

11 If a holder of a COVID-19 medical device authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay,

Discretionary revocation

12 (1) The Minister may revoke, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 9(2).

Mandatory revocation

(2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 11(a).

Labelling

13 (1) A person must not import or sell a COVID-19 medical device for which a COVID-19 medical device authorization has been issued or conduct a clinical trial in respect of such a device unless the device has a label that sets out the following information:

Presentation of information

(2) The information required by subsection (1) to be set out on the label must be in English and in French.

Incident reporting

14 A holder of a COVID-19 medical device authorization must, within 10 days after becoming aware of an incident inside or outside Canada involving a COVID-19 medical device for which the authorization has been issued, report the incident to the Minister and specify the nature of the incident and the circumstances surrounding it.

Records

15 (1) A holder of a COVID-19 medical device authorization must record, handle and store all information in respect of the clinical trial for which the authorization has been issued in a manner that allows for the complete and accurate reporting as well as the interpretation and verification of the information.

Content

(2) The holder of the authorization must maintain complete and accurate records, which include the information and material referred to in subsection 4(2), in respect of a COVID-19 medical device for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with this Interim Order.

Retention period

(3) The holder of the authorization must retain all records for the period during which this Interim Order is in force.

Distribution records

16 (1) A holder of a COVID-19 medical device authorization must maintain a distribution record in respect of each device that is imported or sold under the authorization or tested in a clinical trial under the authorization.

Withdrawal

(2) The distribution record must contain sufficient information to permit complete and rapid withdrawal of the COVID-19 medical device for which the authorization has been issued.

Retention period

(3) The holder of the authorization must retain the distribution record for the period during which this Interim Order is in force.

Timely retrieval

(4) Distribution records must be maintained in a manner that will allow their timely retrieval.

Complaint handling

17 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, maintain records of the following:

Documented procedures

18 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, establish and implement documented procedures that will enable the holder to carry out

Information — recall

19 (1) A holder of a COVID-19 medical device authorization must, on or before recalling a COVID-19 medical device for which the authorization has been issued, provide the Minister with the following:

Information — after completion of recall

(2) The holder of the authorization must, as soon as feasible after the completion of the recall, prepare and submit to the Minister

Submission on holder's behalf

(3) Despite subsections (1) and (2), the holder of the authorization may permit the importer of the COVID-19 medical device to prepare and submit, on the holder's behalf, the information and material required under those subsections if the importer has the same information and material.

Notice to Minister

(4) The holder of the authorization must notify the Minister, in writing, if the holder has permitted the importer to prepare and submit the information and material with respect to the recall on the holder's behalf.

PART 2

COVID-19 Drugs

Application

20 (1) An application for a COVID-19 drug authorization must be signed and dated by the applicant's senior medical or scientific officer in Canada and their senior executive officer and must be submitted to the Minister in the form and manner specified by the Minister.

Content

(2) The application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

Marketed drug

(3) If the application for the authorization is in respect of a COVID-19 drug that meets the requirements of paragraphs 27(a) to (c), the application must also contain

Issuance

21 The Minister must issue a COVID-19 drug authorization if the following requirements are met:

Additional information prior to clinical trial

22 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued or conduct a clinical trial in respect of such a drug unless the holder has

Terms and conditions

23 The Minister may, at any time, impose terms and conditions on a COVID-19 drug authorization or amend those terms and conditions.

Amendment

24 (1) A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued or conduct a clinical trial in respect of such a drug if the substance of any of the information or material referred to in paragraph 20(2)(a) or (m) is significantly different from the substance of the information or material contained in the application, unless

Immediate change

(2) Despite subsection (1), if the holder of the authorization is required to make an immediate change to the substance of any of the information or material referred to in paragraph 20(2)(a) or (m) because the clinical trial or the use of the COVID-19 drug that is tested in the clinical trial endangers the health of a clinical trial subject or other person, the holder may immediately make the change.

Application to amend

(3) The holder of the authorization must, within 15 days after the day on which the change is made, submit an application under subsection (1) to amend the authorization.

Prohibition — import

25 A holder of a COVID-19 drug authorization must not import a COVID-19 drug for which the authorization has been issued if the sale of the drug would constitute a violation of the Act.

Prohibition — import and sale

26 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued unless the holder has a representative in Canada who is responsible for the sale of the drug.

Marketed drugs

27 Paragraphs 20(2)(e) to (l), section 33 and paragraphs 35(2)(a) to (c) do not apply to a COVID-19 drug for which a COVID-19 drug authorization has been issued if

Good clinical practices

28 A holder of a COVID-19 drug authorization must ensure that the clinical trial for which the authorization has been issued is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, must ensure that

Suspension

29 (1) The Minister may suspend, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if

Reinstatement

(2) The Minister must reinstate a COVID-19 drug authorization if the holder of the authorization submits to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.

Additional information and material

30 (1) The Minister may request that an applicant for a COVID-19 drug authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.

Form and manner

(2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.

Discontinuance

31 If a holder of a COVID-19 drug authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay,

Discretionary revocation

32 (1) The Minister may revoke, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 29(2).

Mandatory revocation

(2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 31(a).

Labelling

33 (1) A person must not import or sell a COVID-19 drug for which a COVID-19 drug authorization has been issued or conduct a clinical trial in respect of such a drug unless the drug has a label that sets out the following information:

Presentation of information

(2) The information required by subsection (1) to be set out on the label must be in English and in French.

Serious unexpected adverse drug reaction

34 A holder of a COVID-19 drug authorization must inform the Minister of any serious unexpected adverse drug reaction that has occurred inside or outside Canada, in respect of the COVID-19 drug that is tested in the clinical trial, as follows:

Records

35 (1) A holder of a COVID-19 drug authorization must record, handle and store all information in respect of the clinical trial for which the authorization has been issued in a manner that allows for the complete and accurate reporting as well as the interpretation and verification of the information.

Content

(2) The holder of the authorization must maintain complete and accurate records in respect of a COVID-19 drug for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with good clinical practices and this Interim Order, and that include the following:

Retention period

(3) The holder of the authorization must retain all records for the period during which this Interim Order is in force.

PART 3
General

Remote written informed consent

36 (1) If a qualified investigator is not able to obtain, in person, the written informed consent of a person to participate in a clinical trial in respect of a COVID-19 medical device for which a COVID-19 medical device authorization has been issued or a COVID-19 drug for which a COVID-19 drug authorization has been issued, the qualified investigator may obtain the written informed consent remotely.

Non-written informed consent

(2) In the case where the person is not able to provide their written informed consent, the qualified investigator may obtain their non-written informed consent if the following conditions are met:

PART 4
Other Clinical Trials

Exemption — certain drugs

37 (1) A person that is authorized under Division 5 of Part C of the Food and Drug Regulations to sell or import a drug for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act.

Clarification — suspension and cancellation

(2) For greater certainty, the exemption does not apply

Definition of clinical trial

(3) In this section, clinical trial has the same meaning as in section C.05.001 of the Food and Drug Regulations.

Exemption — positron-emitting radiopharmaceuticals

38 (1) A person that is authorized under Division 3 of Part C of the Food and Drug Regulations to sell or import a positron-emitting radiopharmaceutical for the purposes of a study — and any other person that conducts the study — is, in respect of the study, exempt from section 3.1 of the Act.

Clarification — suspension and cancellation

(2) For greater certainty, the exemption does not apply

Exemption — natural health products

39 (1) A person that is authorized under Part 4 of the Natural Health Products Regulations to sell or import a natural health product for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act.

Clarification — suspension and cancellation

(2) For greater certainty, the exemption does not apply

Definitions

(3) The following definitions apply in this section.

clinical trial
has the same meaning as in section 63 of the Natural Health Products Regulations. (essai clinique)
natural health product
has the same meaning as in subsection 1(1) of the Natural Health Products Regulations. (produit de santé naturel)

Exemption — medical devices

40 (1) A person that is authorized under Part 3 of the Medical Devices Regulations to sell a medical device for investigational testing — and any person who conducts the testing of the device — is, in respect of the testing, exempt from section 3.1 of the Act.

Exception

(2) The exemption does not apply in respect of any person to whom the medical device can no longer be sold as a result of a measure taken by the Minister under subsection 85(2) of the Medical Devices Regulations.

Suspension — deemed holder

41 (1) An authorization to conduct a clinical trial in respect of a drug is suspended if

Reinstatement

(2) An authorization that is suspended under subsection (1) is reinstated if the authorization referred to in paragraph (1)(b) is reinstated.

Revocation — deemed holder

(3) An authorization to conduct a clinical trial in respect of a drug or medical device is revoked if

Partial suspensions and cancellations

(4) If the authorization referred to in paragraph (1)(b) or (3)(b) is only partially suspended or cancelled, the authorization to conduct the clinical trial is suspended or revoked to the same extent.

PART 5
Transitional Provisions and Repeal

Transitional Provisions

Definition of Interim Order No. 1

42 In sections 43 to 52, Interim Order No. 1 means the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister on May 23, 2020 and published in the Canada Gazette, Part I, on June 6, 2020.

Applications

43 An application for a COVID-19 medical device authorization or a COVID-19 drug authorization 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 a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under this Interim Order.

Authorizations

44 A COVID-19 medical device authorization or a COVID-19 drug authorization that was issued or reinstated by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization issued or reinstated under this Interim Order.

Approval — research ethics board

45 Any approval of a research ethics board that was obtained by the holder of a COVID-19 medical device authorization or the holder of a COVID-19 drug authorization under Interim Order No. 1 before the day on which this Interim Order is made is deemed to be an approval of the research ethics board obtained by the holder of a COVID-19 medical device authorization or the holder of a COVID-19 drug authorization under this Interim Order.

Terms and conditions

46 Any terms and conditions that were imposed on a COVID-19 medical device authorization or a COVID-19 drug authorization 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 COVID-19 medical device authorization or the COVID-19 drug authorization under this Interim Order.

Amendment applications

47 An application to amend a COVID-19 medical device authorization or a COVID-19 drug authorization 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 a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under this Interim Order.

Amended authorization

48 A COVID-19 medical device authorization or a COVID-19 drug authorization 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 revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization amended to the same extent under this Interim Order.

Suspension

49 A COVID-19 medical device authorization or a COVID-19 drug authorization that was suspended in whole or in part by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization suspended in whole or in part to the same extent under this Interim Order.

Request — additional information and material

50 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.

Discontinuance

51 A notice of discontinuance provided to the Minister, or information in respect of the discontinuance provided in writing to the qualified investigator, by the holder of a COVID-19 medical device authorization or a COVID-19 drug authorization under Interim Order No. 1 before the day on which this Interim Order is made is deemed to be a notice of discontinuance or information provided under this Interim Order.

Revocation in part

52 A COVID-19 medical device authorization or a COVID-19 drug authorization that was revoked in part by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization revoked in part to the same extent under this Interim Order.

Repeal

53 The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister of Health on May 23, 2020 and published in the Canada Gazette, Part I, on June 6, 2020, is repealed.

EXPLANATORY NOTE

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

Proposal

This interim order (IO) No. 2 was made by the Minister of Health on May 3, 2021. IO No. 2 repeals and replaces the (ARCHIVED) Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (IO No. 1), which came into force on May 23, 2020.

Objective

IO No. 2 supports Canada's continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

Background

COVID-19

COVID-19 is a novel infectious respiratory disease caused by a strain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first detected in December 2019. It is caused by a new strain of coronavirus never before seen in humans.

COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it can cause pneumonia, acute respiratory distress syndrome, kidney failure and death.

The World Health Organization declared a global pandemic related to COVID-19 on March 11, 2020. COVID-19 has now affected most countries across 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 120 million cases and over 2.5 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 March 25, 2021, is over 900 000. The situation continues to evolve and change.

From the outset, the COVID-19 pandemic created an urgent need for drugs and devices used to diagnose, treat, mitigate or prevent COVID-19. The pandemic also created a need for a pathway to facilitate clinical trials for these potential COVID-19 drugs and medical devices.

Health Canada permits the importation and sale of drugs and devices in clinical trials if they meet safety requirements and if the trial is expected to meet its objectives. Among other requirements, Health Canada assesses available information about the drug or device. Health Canada also requires that a research ethics board review and approve a trial before it starts at each site.

While approved trials are ongoing, Health Canada monitors the emerging safety data by assessing serious unexpected adverse drug reactions, medical device incidents and other information. Health Canada may also carry out routine or for-cause inspections to verify that these clinical trials are taking place in accordance with the regulatory requirements.

Government of Canada's response

The health and safety of Canadians are the Government of Canada's top priority during the COVID-19 pandemic. Therefore, the Minister of Health took action to provide a more efficient way to conduct clinical trials related to COVID-19, while upholding strong patient safety requirements and validity of trial data.

IO No. 1 provided a new optional pathway for authorizing

Clinical trials authorized under this pathway could assess

The authorization scheme in IO No. 1 also gave the Minister a greater ability to

Thirty-six clinical trial applications have been submitted under this pathway as of April 16, 2021.

Order in Council SI/2020-39 that accompanied IO No. 1 brought into force several subsections of the Budget Implementation Act, 2019, No. 1, including section 3.1 of the Food and Drugs Act. This section prohibits the conduct of a clinical trial unless the person holds an authorization to do so.

Implications

In accordance with the Food and Drugs Act, IO No. 2 is in effect for 14 days unless approved by the Governor in Council.

Flexible pathway

As with the previous Interim Order, IO No. 2 increases efficiencies and reduces the administrative burden caused by certain requirements. This authorization pathway, established in IO No. 1 and now continued in IO No. 2, is designed to better facilitate clinical trials during a public health emergency. It also makes it easier to set up and run multi-site trials.

The pathway increases flexibility by, for example, expanding the scope of the definition of “qualified investigator” for clinical trials for drugs. This expanded scope permits additional licensed health care professionals, such as nurse practitioners, to fill that role. Only a physician or dentist may conduct a clinical trial under the pre-existing pathway in the Food and Drug Regulations.

This increased flexibility will help to facilitate trials

Through the pathway, an applicant for a medical device clinical trial authorization is not limited to a manufacturer and importer. An applicant may also be an investigator, such as researcher, clinician or health care facility. Under IO No. 1 and now IO No. 2, an investigator in a medical device clinical trial, independent of the medical device manufacturer, can also apply for an authorization.

The pathway also provides two other means of obtaining informed consent when prospective clinical trial participants are unable to consent in person or in writing:

  1. permits remote, written informed consent of a prospective participant when they cannot be in the same location as the qualified investigator; and
  2. permits non-written informed consent when a prospective participant cannot provide written informed consent.

These measures will also continue to reduce barriers to the provision of consent given the restrictions that are in place due to COVID-19. For instance, the infection control practices in most hospitals may prohibit people who are in isolation from accessing paper.

Other changes from the Food and Drug Regulations and Medical Devices Regulations introduced by the IO No. 1 pathway include

Under IO No. 2, the Minister also continues to have the ability to partially suspend or revoke a trial authorization. This allows her to suspend a single treatment group of a randomized trial if needed, while allowing the rest of the trial to continue so that other participants may continue to receive a promising therapy. This ability offers increased flexibility for the type of innovative trial designs being pursued for COVID-19 drugs and devices.

Oversight of clinical trials

The health and safety of clinical trial participants are as important as ever. As with the previous interim order, IO No. 2 continues to provide the Minister with certain abilities to oversee and intervene in clinical trials, as needed, in the best interest of clinical trial participants.

These abilities include the use of terms and conditions on clinical trial authorizations, which may be applied on a case-by-case basis to address uncertainties and mitigate risks. Terms and conditions may include

Another oversight ability permits the Minister to request additional information about a clinical trial application or authorization. This information may be considered necessary to enable the Minister to determine whether to issue, amend, suspend or cancel (in whole or in part) the authorization.

As with all clinical trials conducted in Canada, Health Canada will monitor the safety of the drugs and devices used under IO No. 2. If required, Health Canada will take immediate action, including the suspension or cancellation of authorizations, to protect the health and safety of Canadians.

IO No. 2 also includes provisions to ensure that all authorizations and suspensions for clinical trials issued under IO No. 1, including any terms and conditions, will remain in effect. Further, any applications made under IO No. 1 that are outstanding at the time of its repeal will be considered as applications made under IO No. 2.

As was the case under IO No. 1, the new authorization pathway is optional. The existing pathways in the Food and Drug Regulations and the Medical Devices Regulations continue to be available. Authorization holders continue to hold their existing authorizations under the regulatory framework for which they were approved.

IO No. 2 also addresses two concerns that were raised by the Standing Joint Committee for the Scrutiny of Regulations. These changes include

Consultation

Information gathered from the consultations held in the spring of 2020 for IO No. 1 helped to inform IO No. 2. Consultation sessions sought input on some of the concepts from key stakeholders, including

Many aspects of IO No. 2 have leveraged elements from the forthcoming broader clinical trials modernization initiative. To date, outreach and other engagement activities have involved in-person and online consultations.

Health Canada continues to engage with the CIHR, the Canadian Association of Research Ethics Boards and other research ethics boards that review clinical trials in Canada. Engagement sessions on clinical trial oversight and implementation are held every month. Through this initiative, policymakers, regulators, funders and oversight bodies are collaborating and sharing information on clinical trials.

In December 2020, Health Canada informed industry, health care practitioners, hospital and university researchers, research institutes and academia, and health care partners about IO No. 2, including holding webinars. Written stakeholder feedback was encouraged between December 10, 2020, and January 25, 2021. There were no comments or questions related to IO No. 2.

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
Address locator: 3000A
Ottawa, Ontario
K1A 0K9
Email: hc.lrm.consultations-mlr.sc@canada.ca

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

May 11, 2021

Diane Belanger
Official Document Registrar

DEPARTMENT OF TRANSPORT

AERONAUTICS ACT

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28

Whereas the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28 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 e and 4.9footnote f, paragraphs 7.6(1)(a)footnote g and (b)footnote h and section 7.7footnote i of the Aeronautics Actfootnote j;

And whereas, pursuant to subsection 6.41(1.2)footnote k of that Act, the 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 Minister of Transport, pursuant to subsection 6.41(1)footnote k of the Aeronautics Act footnote j, makes the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28.

Ottawa, May 5, 2021

Omar Alghabra
Minister of Transport

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28

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.

Evidence — result of test

10.3 (1) 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 — location of test

(2) For the purposes of subsection (1), the COVID-19 molecular test must have been performed in a country or territory that is not listed in Schedule 1.

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) and (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) and (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 3 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 3 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. 27, made on April 22, 2021, is repealed.

SCHEDULE 1

(Subsection 10.3(2))

Countries and Territories
Name
India
Pakistan

SCHEDULE 2

(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 3

(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
Subsection 10.3(1) 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

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  
Director Business Development Bank of Canada  
President and Chief Executive Officer Business Development Bank of Canada  
Member Canada Council for the Arts  
Vice-Chairperson Canada Council for the Arts  
President and Chief Executive Officer Canada Development Investment Corporation  
Commissioner for Employers Canada Employment Insurance Commission  
Director Canada Infrastructure Bank  
Director Canada Mortgage and Housing Corporation  
Chairperson Canada-Nova Scotia Offshore Petroleum Board  
Member of the Board of Directors Canada Post  
Member Canadian Cultural Property Export Review Board  
Chairperson Canadian Dairy Commission  
Chief Executive Officer Canadian Dairy Commission  
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  
Director Canadian Museum of History  
Director Canadian Race Relations Foundation  
Temporary Member Canadian Transportation Agency  
Chairperson Destination Canada  
Director Destination Canada  
Director Farm Credit Canada  
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  
Governor International Development Research Centre  
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 Research Council Canada  
Member National Seniors Council  
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  
Director Public Sector Pension Investment Board of Canada  
Member Public Service Pension Advisory Committee  
Chairperson Standards Council of Canada  
Registrar Supreme Court of Canada  
Director
(Federal)		 Toronto Port Authority  
Chairperson and Member Transportation Appeal Tribunal of Canada  
Vice-Chairperson Transportation Appeal Tribunal of Canada  
Director
(Federal)		 Trois-Rivières Port Authority