Canada Gazette, Part I, Volume 154, Number 50: GOVERNMENT NOTICES

December 12, 2020

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Memorandum of Understanding Respecting the National Air Pollution Surveillance Program Memorandum of Understanding

Notice is hereby given that the Minister of the Environment (“the Minister”) has signed a Memorandum of Understanding (MOU) with all provincial and territorial governments. The Minister is publishing the MOU in accordance with subsection 9(6) of the Canadian Environmental Protection Act, 1999.

The MOU became effective October 25, 2019, and will expire October 25, 2024.

Jonathan Wilkinson
Minister of the Environment

MEMORANDUM OF UNDERSTANDING RESPECTING THE NATIONAL AIR POLLUTION SURVEILLANCE PROGRAM

BETWEEN

The Government of Canada
(hereinafter referred to as “Environment and Climate Change Canada” or “ECCC”)

and

The governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, Quebec, Saskatchewan, and the Northwest Territories, Nunavut, and Yukon (hereinafter referred to as “the Provinces and Territories”)

WHEREAS

• 1. The National Air Pollution Surveillance (NAPS) Program was established in 1969 as a collaborative partnership between the Government of Canada and the Provinces and Territories to facilitate and coordinate collection of ambient air quality data that is representative of populated (urban and rural) areas across Canada;
• 2. Ambient air quality monitoring is an essential component of Canada’s air quality management and research programs;
• 3. This collaboration has evolved into a formal agreement with the Parties entering into memoranda of understanding in 2004 and 2012, each for a period of five years;
• 4. The Parties wish to continue their partnership regarding the NAPS Program and have therefore agreed to enter into this Memorandum of Understanding (MOU);
• 5. The federal Minister of the Environment may, pursuant to section 9 of the Canadian Environmental Protection Act, 1999, with the approval of the Governor-in-Council, enter into an agreement with a government with respect to the administration of this Act;
• 6. By Order-in-Council (OiC) 81000-3-1807 dated June 22, 2019, the federal Minister of the Environment is authorized to sign this MOU for and on behalf of the Government of Canada and to provide certain equipment to the Provinces and Territories under this MOU;
• 7. This MOU is based on the principles of collaboration and equitable sharing of costs and work, subject to each Party’s available resources; and
• 8. This MOU will respect the principles found in the Canadian Council of Ministers of the Environment (CCME) Statement of Principles to Guide Cooperative Arrangements on Environmental Monitoring and Reporting (2002) [PDF] (PDF), which states, among other things, that all Parties have equal standing, will act in a transparent manner, and will respect each Party’s jurisdiction, needs, capabilities and mandate.

NOW THEREFORE the Parties express their desire and willingness to continue their collaboration with each other as set out below, without imposing any binding legal obligations upon any of the Parties, as follows:

1.0 DEFINITIONS

In this MOU, the following words or expressions have the following meanings:

“Annex”

means an annex to this MOU, being a Province- or Territory-specific table of NAPS Sites identifying their locations, the pollutants monitored, the Monitoring Equipment and national programs supported by these sites.

“Annual Report”

means a summary of a Party’s activities from the previous Fiscal Year, including accomplishments, changes to organizational structure, NAPS Site updates (e.g. new sites, closures, relocations, and installation of Monitoring Equipment).

“AQHI”

means Air Quality Health Index, which is a multi-pollutant index based on the combined concentrations of fine particulate matter (PM_2.5), ozone and nitrogen dioxide (NO₂).

“Canada-Wide Air Quality Database”

means an ECCC-managed collection of Quality Assured Continuous Data and Quality Assured Integrated Data generated from the NAPS Sites.

“Component”

means a replacement part required for the ongoing operation of Monitoring Equipment.

“Continuous Data”

means data that is collected and owned by Provinces and Territories at NAPS Sites using continuous Monitoring Equipment.

“Effective Date”

means the date on which the last Party to sign this MOU signs it.

“Fiscal Year”

means the period from April 1 in any year to March 31 in the following calendar year.

“Integrated Data”

means data that is generated from chemical and gravimetric analysis by the ECCC laboratories in Ottawa on Integrated Samples collected at NAPS Sites and owned by ECCC.

“Integrated Sample”

means an ambient air sample collected by Provinces and Territories at NAPS Sites on Sampling Media from Monitoring Equipment over a specific time period (e.g. 24 hours).

“Land and Infrastructure”

means the property upon which the NAPS Site is located, including site acquisition, lease, shelter, utilities, site access, permits and fees, security, safety equipment and site preparation.

“Monitoring Equipment”

means the system of monitoring and sampling equipment necessary to produce Continuous Data and collect Integrated Samples at NAPS Sites.

“NAPS Guidance”

means the National Air Pollution Surveillance Program Ambient Air Monitoring and Quality Assurance/Quality Control Guidelines [CCME, 2019].

“NAPS Program”

means the sum of the Parties’ activities involved in air quality monitoring, including the collection, validation, storage and dissemination of Continuous Data and Integrated Data from NAPS Sites.

“NAPS Program Manager”

means an air quality monitoring manager designated by each Party to oversee the implementation of this MOU on behalf of that Party and actively participate in the NAPS Program and meetings with all Parties.

“NAPS Site”

means a site selected for inclusion in the NAPS Program by ECCC and the Province or Territory where the site is located, as specified in the Annexes.

“Party”

means ECCC or one Province or Territory, and “Parties” means, collectively, ECCC and all Provinces and Territories.

“Quality Assured”

means, in relation to Quality Assured Continuous Data and Quality Assured Integrated Data, data that meets mutually agreed-upon data quality standards specified in the NAPS Guidance.

“Sampling Media”

means filters, canisters, cartridges and filter packs for use with Monitoring Equipment.

“Work Plan”

means an annual summary outlining a Party’s planned activities for the upcoming Fiscal Year, emerging issues, changes to organizational structure, NAPS Site updates (e.g. new sites, closures, relocations) and proposed new or replacement Monitoring Equipment, and Components.

2.0 PURPOSE

2.1 The MOU will

• (a) outline the general terms and conditions of collaboration and co-operation among the Parties in the overall management and support of the NAPS Program;
• (b) facilitate collaboration and co-operation among the Parties in monitoring and reporting activities
  • (i) to support air quality information needs of existing regional, national and international programs and agreements, and
  • (ii) to support emerging air quality reporting initiatives where the Parties mutually agree on their respective scope; and
• (c) identify the Parties’ roles and responsibilities in relation to the above.

3.0 ROLES AND RESPONSIBILITIES

• 3.1 The Parties will carry out this MOU in accordance with the terms and conditions herein and subject to each Party’s available resources.
• 3.2 ECCC’s roles and responsibilities under this MOU will be to
  • (a) collaborate with the Provinces and Territories in the overall management of the NAPS Program;
  • (b) select new or relocated NAPS Sites in agreement with the Province or Territory;
  • (c) coordinate a national quality assurance and audit program, which includes provision of laboratory calibration services, monitoring station and system audits, training and technical support, inter-laboratory studies and projects for the NAPS Program as specified in the Work Plans;
  • (d) provide Monitoring Equipment to the Provinces and Territories as specified in the Annexes. Such equipment will remain the property of ECCC;
  • (e) in accordance with the Provinces’ and Territories’ Work Plans, provide
    • (i) replacement Monitoring Equipment for NAPS Sites after a useful life expectancy of approximately 12 years to ensure data quality, to keep up to date with changes in monitoring technology, and address evolving priorities for ambient air quality monitoring,
    • (ii) Components for ECCC Monitoring Equipment when the cost of a Component exceeds one hundred dollars ($100),
    • (iii) assistance with installation of ECCC Monitoring Equipment, as required,
    • (iv) Sampling Media for ECCC Monitoring Equipment at NAPS Sites, and
    • (v) Monitoring Equipment, Sampling Media and laboratory analysis for air quality monitoring projects, outside of core NAPS Program activities, in collaboration with the Provinces and Territories;
  • (f) for in-year requests (not included in the Work Plans) by the Provinces and Territories, provide Components for ECCC Monitoring Equipment if the cost of a Component exceeds five hundred dollars ($500);
  • (g) perform laboratory analysis on Integrated Samples for the NAPS Program at ECCC laboratories in Ottawa;
  • (h) assume shipping costs to Provinces and Territories for Sampling Media, Components and Monitoring Equipment provided by ECCC;
  • (i) submit to the Provinces and Territories, Quality Assured Integrated Data from NAPS Sites collected in the previous calendar year by December 31^st of the current year;
  • (j) share Quality Assured Integrated Data with the Provinces and Territories in accordance with the terms and conditions of section 4.0 of this MOU;
  • (k) maintain the Canada-Wide Air Quality Database for storing Quality Assured Continuous Data and Quality Assured Integrated Data;
  • (l) create and maintain a website for sharing of information among the Parties;
  • (m) coordinate national data reporting initiatives;
  • (n) prepare and share its Work Plan and Annual Report with the other Parties; and
  • (o) For the NAPS Sites identified as “AQHI” in the Annexes, publish, with acknowledgement of the Provinces and Territories, AQHI forecasts on a website and other public dissemination pathways, in addition to making them available to media and other sources.
• 3.3 The roles and responsibilities of each Province and Territory under this MOU will be to
  • (a) collaborate with ECCC in the overall management of the NAPS Program;
  • (b) provide the Land and Infrastructure and its associated costs for each NAPS Site, unless otherwise indicated in the Annexes;
  • (c) install new and replacement Monitoring Equipment and Components provided by ECCC for NAPS Sites;
  • (d) ensure the maintenance, calibration and operation of the NAPS Monitoring Equipment at NAPS Sites in accordance with the NAPS Guidance;
  • (e) supply to ECCC, upon request, an up-to-date listing of NAPS Monitoring Equipment and their location (serial numbers and the associated NAPS Site ID);
  • (f) assume shipping costs for returning Sampling Media, Components and Monitoring Equipment to ECCC;
  • (g) collect, process, manage, analyze and report Continuous Data for NAPS Sites;
  • (h) submit, to ECCC, Quality Assured Continuous Data from NAPS Sites collected in the previous calendar year no later than June 30 of the current year for inclusion in the Canada-Wide Air Quality Database;
  • (i) share Quality Assured Continuous Data with ECCC in accordance with the terms and conditions of section 4.0 of this MOU;
  • (j) conduct projects, outside of core NAPS Program activities, for air quality monitoring, sampling and analysis in collaboration with the other Parties as indicated in their Work Plan;
  • (k) prepare and share their Work Plan and Annual Report with the other Parties; and
  • (l) submit near-real time Continuous Data to ECCC for the production of air quality forecasts for the NAPS Sites identified as “AQHI” in the Annexes.

4.0 DATA SHARING

• 4.1 Subject to the Parties’ respective obligations, which may arise pursuant to applicable federal and provincial legislation, policies, and contractual obligations, the Parties agree that
  • (a) Continuous Data belong to the Province or Territory responsible for the NAPS Site where it was generated. Subject to paragraph 3.3(l), each of the Provinces and Territories undertakes to disseminate their Continuous Data to the public as soon as is practicable;
  • (b) the Provinces and Territories grant to ECCC a worldwide, non-exclusive and non-restricted right to exercise all of the intellectual property rights in respect of the Quality Assured Continuous Data, which for sake of clarity includes the right to make the Quality Assured Continuous Data available to the public
    • (i) on terms that are no less generous than what is included herein in order to promote access to open data, and
    • (ii) including on websites and in publications, provided that the owner of the Quality Assured Continuous Data is identified;
  • (c) Integrated Data belong to ECCC. ECCC undertakes to share its Quality Assured Integrated Data fully and freely among the Provinces and Territories and to disseminate it to the public as soon as is practicable;
  • (d) ECCC grants to the Provinces and Territories a worldwide, non-exclusive and non-restricted right to exercise the intellectual property rights in respect of the Quality Assured Integrated Data, which for sake of clarity includes the right to make the Quality Assured Integrated Data available to the public
    • (i) on terms that are no less generous than what is included herein in order to promote access to open data, and
    • (ii) including on websites and in publications, provided ECCC is identified as the owner of the Quality Assured Integrated Data; and
  • (e) the sharing of data covered by this MOU does not preclude the development of other data sharing agreements that may be required to support other programs and applications.

5.0 MEETINGS

Annual Management Meetings

• 5.1 The NAPS Program Managers or their designated alternate will meet twice a year to discuss the overall management of the NAPS Program, including sharing information on the Parties’ respective air monitoring activities, budgets and resources, and addressing issues related to the implementation of this MOU, technology transfer, and ambient air monitoring policy updates.
• 5.2 The NAPS Program Managers will meet annually in person no later than June 21. They will also hold an annual conference call no later than December 21.
• 5.3 The annual in-person meeting will be co-chaired by the ECCC NAPS Program Manager and a NAPS Program Manager from a Province or Territory who will be selected by the Parties for a term of one year commencing at the time of the conference call.
• 5.4 The provincial or territorial co-chair will host the annual in-person meeting and, in collaboration with ECCC, will decide on the location for the meeting. ECCC will be responsible for the costs associated with the meeting room and secretariat services. Participants will be responsible for their costs to attend the meeting, including travel and accommodation.
• 5.5 In collaboration with the Provinces and Territories, ECCC will develop an agenda that will be distributed at least 60 days prior to the annual in-person meeting.
• 5.6 ECCC will organize the annual conference call and be responsible for the costs associated with the call.
• 5.7 The summary and action items from the in-person meeting and conference call will be prepared by the ECCC secretariat. They will be distributed, reviewed and approved by the Parties, and actioned for the subsequent meeting or call.

Technical Meetings

• 5.8 The Parties may hold technical meetings, on an as-needed basis, to discuss specific issues related to the NAPS Program. If required, the Parties may establish technical committees to address any issues or other matters related to the NAPS Program. Depending on the nature of the technical meetings or committees, the Parties will decide among one another who will organize, host, attend and be financially responsible for these meetings or committees.

6.0 WORK PLANS AND ANNUAL REPORTS

• 6.1 Each Party will prepare a draft Work Plan and an Annual Report no later than 60 days after the beginning of a Fiscal Year.
• 6.2 ECCC will collate and post on a password-protected website managed by ECCC
  • (a) the Parties’ finalized Work Plans to become the NAPS Program Work Plan;
  • (b) the Annual Reports; and
  • (c) the meeting presentations, summary and action items of the annual in-person management meeting and conference call.

7.0 TERM AND REVIEW

• 7.1 This MOU will take effect on the Effective Date for a term of five years.
• 7.2 Unless otherwise agreed to by the Parties, the Parties agree to review this MOU one year prior to its expiry with the intent to continue their collaboration on the NAPS Program.

8.0 WITHDRAWAL

• 8.1 A Party may withdraw from this MOU by providing the other Parties with three months’ written notice confirming its intention to withdraw.
• 8.2 The Parties agree that should a Party to the MOU withdraw,
  • (a) the Quality Assured Continuous Data or Quality Assured Integrated Data made available by the withdrawing Party to any of the other Parties up until the official withdrawal date shall remain available to all the other Parties; and
  • (b) at its own cost, the withdrawing Party will remove and return to ECCC, no later than 60 days after the official withdrawal date, all Monitoring Equipment and Sampling Media provided by ECCC.

9.0 AMENDMENT

• 9.1 Subject to subsection 9.3, this MOU may be amended at any time with the consent of all Parties. To be valid, any amendment to this MOU must be in writing and signed by all the Parties, while this MOU is in force.
• 9.2 The signing authorities for the Parties with respect to any written amendments to this MOU provided for in subsection 9.1 are the signatories to this MOU or such other representatives of the respective Parties who may occupy said positions from time to time.
• 9.3 For any proposed amendments made to the Annexes by one or more Parties, the written consent of only those Parties affected by the amendments is required. For the purpose of amending Annexes, those persons holding the positions identified in Schedule A may sign on behalf of the Party they represent.

10.0 NOTICES AND PRINCIPAL REPRESENTATIVES

• 10.1 Except for the copy of the executed MOU to be provided by each Party under subsection 12.1, notices under this MOU must be in writing and delivered by post, email, personal delivery or facsimile and addressed to the relevant Party representative(s) in Schedule A.
• 10.2 Notices will be deemed to have been given,
  • (a) in the case of post, seven days after such notice is mailed; or
  • (b) in the case of an email, personal delivery or facsimile, one day after such notice is sent by the other Party. In the event of a postal disruption, notices must be given by email, personal delivery, or facsimile.
• 10.3 Unless the Parties expressly agree in writing to additional methods of notice, notices may only be provided by the methods contemplated in this section.

11.0 LEGAL STATUS

• 11.1 The Parties agree that this MOU constitutes a non-binding administrative agreement among the Parties and nothing in this MOU is to be construed as creating any financial, legal or contractual relations among the Parties enforceable by a court of competent jurisdiction. This MOU is entered into solely for the purposes of sharing information and better management of financial and technical resources of the Parties, which will result in more effective monitoring of air quality in Canada.

12.0 COUNTERPARTS

• 12.1 This MOU may be signed in several counterparts and each counterpart will constitute an original document; these counterparts taken together will constitute one and the same MOU. The Parties agree that signed counterparts will be transmitted electronically (e.g. by fax or email) and that such counterparts will be treated as originally executed signed documents. Each Party undertakes to provide the CCME with a copy of the original MOU bearing actual original signatures within a reasonable period of time following the signature of this MOU.

13.0 LANGUAGE

• 13.1 This MOU is prepared in the English and French languages, and each version is equally authoritative.

14.0 ENTIRE AGREEMENT

• 14.1 This MOU, its recitals, its Schedule and Annexes constitute the entire agreement among the Parties with respect to the subject matter of this MOU and supersedes all previous negotiations, communications, and other agreements, whether written or oral, among the Parties pertaining to such subject matter.

Memorandum of Understanding Respecting the National Air Pollution Surveillance Program

Signed by:

Canada

Stephen Lucas, Deputy Minister, Environment and Climate Change Canada, signed this 29th day of August, 2019

Alberta

• Beverly Yee, Deputy Minister, Environment and Parks, signed this 23rd day of August, 2019
• Coleen Volk, Deputy Minister, Intergovernmental Relations, signed this 25th day of October, 2019

British Columbia

Mark Zacharias, Deputy Minister, Environment and Climate Change Strategy, signed this 23rd day of August, 2019

Manitoba

Bruce Gray, Deputy Minister, Sustainable Development, signed this 7th day of October, 2019

New Brunswick

Kelli Simmonds, Deputy Minister, Environment and Local Government, signed this 27th day of September, 2019

Newfoundland and Labrador

• Dan Michielson, Acting Deputy Minister, Municipal Affairs and Environment, signed this 11th day of September, 2019
• Patricia A. Hearn, Deputy Minister, Intergovernmental Affairs, signed this 12th day of September, 2019

Nova Scotia

Frances Martin, Deputy Minister, Environment, signed this 27th day of August, 2019

Ontario

Serge Imbrogno, Deputy Minister, Environment, Conservation and Parks, signed this 24th day of June, 2019

Prince Edward Island

Brad Colwill, Deputy Minister, Environment, Water and Climate Change, signed this 10th day of September, 2019

Quebec

• Marc Croteau, Sous-ministre, Environment and the Fight against Climate Change, signed this 17th day of September, 2019
• Jean-Stéphane Bernard, Secrétaire général associé, Relations canadiennes et Francophonie canadienne, signed this 25th day of September, 2019

Saskatchewan

Lin Gallagher, Deputy Minister, Environment, signed this 3rd day of September, 2019

Northwest Territories

Joe Dragon, Deputy Minister, Environment and Natural Resources, signed this 28th day of August, 2019

Nunavut

Jimmy Noble Jr., Deputy Minister, Environment, signed this 4th day of October, 2019

Yukon

John Bailey, Deputy Minister, Environment, signed this 23rd day of August, 2019

Schedule A

For ECCC
Manager
Analysis and Air Quality Section
Air Quality Research Division

For Alberta
Manager
Air Monitoring Operations
Environmental Monitoring and Science Division

For British Columbia
Executive Director
Knowledge Management Branch
Environmental Sustainability and Strategic Policy Division

For Manitoba
Assistant Deputy Minister
Conservation Programs

For New Brunswick
Manager
Air Sciences Section

For Newfoundland and Labrador
Manager
Environmental Science and Waste Management
Pollution Prevention Division

For Nova Scotia
Manager
Air Quality Unit
Sustainability and Applied Sciences Division

For Ontario
Manager
Air Monitoring and Transboundary Air Science Section
Environmental Monitoring and Reporting Branch

For Prince Edward Island
Executive Director
Climate Change and Environment Division

For Quebec
Directrice
Direction de l’information sur le milieu atmosphérique

For Saskatchewan
Director
Air and Land Management
Environmental Protection Branch

For the Northwest Territories
Director
Environmental Stewardship and Climate Change Division

For Nunavut
Director
Environmental Protection Service

For Yukon
Director
Environmental Programs Branch

DEPARTMENT OF THE ENVIRONMENT DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of eight substances in the Phenol-formaldehyde Resins Group specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas the eight substances identified in the annex below are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

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

And whereas it is concluded that the substances do not meet any 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 take no further action on these substances at this time under section 77 of the Act.

Jonathan Wilkinson
Minister of the Environment

Patty Hajdu
Minister of Health

ANNEX

Summary of the screening assessment of the Phenol-formaldehyde Resins Group

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of Environment and the Minister of Health have conducted a screening assessment of eight substances referred to collectively as the Phenol-formaldehyde Resins Group. Substances in this group were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA. The Chemical Abstracts Service Registry Numbers (CAS RNs), the Domestic Substances List (DSL) names and the abbreviations of these substances are listed in the table below.

Substances in the Phenol-formaldehyde Resins Group

CAS RN table a1 note a	DSL name	Abbreviation
9003-35-4	Phenol, polymer with formaldehyde	PFR
25085-50-1	Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol	t-BPF
26022-00-4	Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol, 4,4’-(1-methylethylidene)bis[phenol] and 4-methylphenol	pC-BPA-tBPF
32610-77-8	Formaldehyde, polymer with N,N’-bis(2-aminoethyl)-1,2-ethanediamine and phenol	TETA-PF
54579-44-1	Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol and 4,4’-(1-methylethylidene)bis[phenol]	BPA-tBPF
55185-45-0	Formaldehyde, polymer with ammonia, 2-methylphenol and phenol	oC-A-PF
67700-42-9	Cashew, nutshell liq., polymer with formaldehyde and phenol	CNSL-PF
71832-81-0	Benzenesulfonic acid, hydroxy-, monosodium salt, polymer with formaldehyde and 4,4’-sulfonylbis[phenol]	NaPS-BPSF
Table a1 note(s) Table a1 note a The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society. Return to table a1 note a referrer

These eight substances were previously evaluated under the Second Phase of Polymer Rapid Screening, which identified phenol-formaldehyde resins as having a low potential to cause ecological harm. However, these substances were identified as requiring further assessment due to their potential human health risk on the basis of structural alerts and/or uses associated with significant consumer exposure. The present assessment summarizes the approach applied during the Second Phase of Polymer Rapid Screening for ecological assessment and further elaborates on the potential for phenol-formaldehyde resins to cause harm to human health in order to reach an overall conclusion under section 64 of CEPA.

Phenol-formaldehyde resins do not occur naturally in the environment but are prepared industrially. They do not contain any reactive functional group (RFG) associated with adverse human health effects. In addition, most phenol-formaldehyde resins in commercial and consumer applications are present in cured form. In Canada, phenol-formaldehyde resins are reported to be used as adhesives, sealants, process aids, intermediates, corrosion inhibitors, fillers, bleaching agents, encapsulating agents, surface active agents, fixing agents (dying auxiliary), and abrasives. They may be used in several industries, such as plastics and rubbers, paints/inks, food packaging, coatings, building/construction, printed circuit board, electronics, oil and gas, metal, auto care, fabrics, textiles, leather, cosmetics, and toys (as thermoset plastic).

No information regarding the manufactured amount of phenol-formaldehyde resins in Canada has been reported. However, it has been reported that volumes as low as 100 kg (for NaPS-BPSF) and in the range of up to 10 000 000 kg (for PFR) were imported into Canada in 2014.

Ecological screening of the eight phenol-formaldehyde resins was performed in the Second Phase of Polymer Rapid Screening (ECCC, HC 2018). These eight resins were identified as either substances with low import and manufacturing quantities or low water solubility/extractability, or were otherwise determined to pose a low ecological risk.

Considering all available lines of evidence presented in this assessment, there is a low risk of harm to the environment from phenol-formaldehyde resins. It is concluded that these substances do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they are 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 their biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Both direct exposure (oral, inhalation, dermal) and indirect exposure (through drinking water) of the general population to phenol-formaldehyde resins are not expected or are thought to be minimal. Therefore, these substances likely present a low risk or no risk of harm to human health.

In addition, on the basis of further evaluation, one of the phenol-formaldehyde resins (pC-BPA-tBPF, CAS RN 26022-00-4) was identified as a substance which could meet the same criteria that are used to designate a substance as being of low concern under the New Substances Notification Regulations (Chemicals and Polymers) of CEPA, in particular, the reduced regulatory requirement (RRR) polymers criterion in paragraph 9(b) of those Regulations. Polymers that are described by this criterion have a limited percentage of low-molecular-weight components, are chemically stable and do not contain reactive components; therefore, they present low human health concern. This substance is therefore unlikely to be a concern to human health.

On the basis of the information presented in this screening assessment, it is concluded that phenol-formaldehyde resins do not meet the criteria under paragraph 64(c) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to human life or health in Canada.

Overall conclusion

It is concluded that the eight substances in the Phenol-formaldehyde Resins Group do not meet any of the criteria set out in section 64 of CEPA.

The screening assessment for these substances is available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF HEALTH

CANNABIS ACT

Notice of intent — Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues

Introduction

This notice provides interested stakeholders with the opportunity to comment on Health Canada’s intent to amend the Cannabis Regulations (CR) and associated regulatory frameworks to facilitate non-therapeutic cannabis research involving human participants and cannabis testing (Part 1).

This notice also provides interested stakeholders with the opportunity to provide feedback and comment on additional regulatory issues: namely public possession limit amounts (i.e. the amounts of various classes of cannabis that are equivalent to 1 gram of dried cannabis, as set out in Schedule 3 to the Cannabis Act); product labelling; micro class and nursery licences; and COVID-19 measures (Part 2).

PART 1: Proposed regulations amending the Cannabis Regulations and associated regulations to facilitate non-therapeutic cannabis research involving human participants and cannabis testing

Background

The Cannabis Act (the Act) creates a strict legal framework for the production, distribution, sale, import, export and possession of cannabis in Canada. Among the objectives of the Act are enhancing public awareness of the health risks associated with cannabis use and providing access to a quality-controlled supply of cannabis.

To help achieve these objectives, Health Canada established a licensing framework to authorize research and development, and testing activities with cannabis under the CR. This included establishing a dedicated research licence class that authorizes activities with cannabis for the purpose of research, as well as authorizing federal licence holders to conduct research and development activities as part of the activities authorized under their licences. Similarly, the authorized activities of government laboratories referred to in section 4 of the CR and the analytical testing licence class permit cannabis testing activities (e.g. for contaminants, cannabinoid content). Other licence holders may also conduct their own testing activities if authorized under their licence, subject to certain conditions.

Under the Cannabis Exemption (Food and Drugs Act) Regulations (CER), cannabis, as defined in the Act and in relation to an activity conducted in accordance with the Act, is exempt from the application of the Food and Drugs Act (FDA) under specific conditions. Cannabis is not exempt from the FDA where it is sold to be used for the purpose of a clinical trial as defined in the Food and Drug Regulations (FDR) [i.e. investigations involving human participants for certain purposes] or an experimental study as defined in those Regulations. Currently, research activities with cannabis involving human participants that meet the definition of clinical trial must meet the relevant requirements of both the CR and the FDR in order to be authorized.

Health Canada recognizes that conducting research involving human participants with cannabis is critical to generating high-quality evidence to provide adult Canadians with the necessary knowledge to make informed decisions on their consumption of cannabis and its risks. Health Canada is aware that researchers are interested in studying the psychological and physiological effects of commercially available cannabis products from a non-therapeutic perspective. Non-therapeutic studies can include investigating the time to onset or duration of effects of a cannabis product, the impact of cannabis use on driving performance, or various other types of public health research. Health Canada is also aware of academic and industry researchers facing challenges in conducting non-therapeutic research involving human participants with cannabis products that are commercially available due to having to comply with the clinical trial requirements under Division 5 of Part C of the FDR.

Regulatory proposal

Health Canada is considering proposing amendments to the CR and associated regulatory frameworks to facilitate non-therapeutic research with cannabis involving human participants, and to facilitate testing activities with cannabis. The proposed amendments would

• (1) Facilitate non-therapeutic cannabis research involving human participants by
  • implementing appropriate health and safety controls, and
  • broadening adverse reaction reporting, where necessary; and
• (2) Streamline and rationalize the licensing framework under the CR to facilitate cannabis-based testing activities, including
  • expanding production, distribution, and sale activities with cannabis reference standards and test kits, and
  • expanding the acceptable qualifications of the “head of laboratory.”

In recognition that Division 5 of Part C may not be ideally suited to regulate non-therapeutic cannabis research involving human participants, Health Canada is considering amendments to the CR, the CER and the FDR to regulate studies of this nature exclusively under the Act and the CR. The regulatory changes would include appropriate public health and public safety controls, as well as controls to ensure the integrity of research findings. Among these controls, the Department is considering proposing amendments to broaden adverse reaction reporting to include licence holders conducting cannabis research involving human participants for non-therapeutic purposes.

Additional related amendments are being considered to the licensing framework under the CR to better support cannabis-based testing activities. Cannabis reference standards play a vital role in assisting laboratories in accurately testing different product characteristics and validating the accuracy of their testing methods, which contribute to maintaining a quality-controlled supply of cannabis products. Reliable testing results help build consumer and industry confidence that the cannabis products available on the retail market are quality controlled and properly labelled (e.g. cannabinoid content is within the labelled amount). Research and analytical testing licence holders, as well as government laboratories referred to in section 4 of the CR, are currently authorized to conduct limited activities with cannabis reference standards (e.g. possess, distribute), but they are not permitted to sell these products. In order for them to do so, they need to obtain a processing licence and comply with good production practices (GPP). GPP requirements are not necessary for reference standards, as they are not intended to be sold to consumers. Therefore, Health Canada is considering exempting licence holders and government laboratories from the GPP requirements when they conduct activities with reference standards. Health Canada also intends to authorize research and analytical testing licence holders, as well as government laboratories, to produce cannabis test kits, and produce and sell cannabis reference standards. The CR already authorizes the sale of test kits.

In addition, Health Canada is considering expanding the acceptable qualifications for a “head of laboratory” (the individual responsible for testing activities). This proposed change intends to help ensure that qualified individuals with sufficient experience and a range of different academic credentials would be eligible to hold this position.

Questions to guide input from interested parties

Below are key questions for which Health Canada is particularly interested in receiving input. However, all input is welcome and should not be limited to responses to these questions. Please provide a rationale and/or evidence to support your views wherever possible.

• 1. How likely would you conduct non-therapeutic cannabis research involving human participants? How many studies do you envision conducting in a year?
• 2. Should the requirements to conduct non-therapeutic cannabis research involving human participants under the CR be similar to those that currently apply to clinical trials under the FDR (e.g. protocol review by a research ethics board, submission of extensive quality [chemistry and manufacturing] information, review of written informed consent, and submission of an investigator’s brochure)? If the requirements should differ, how?
• 3. Should non-therapeutic research involving human participants be restricted to certain participants (e.g. exclude individuals with previous/current mental health or substance use disorders, age restrictions)?
• 4. Should there be restrictions on the types of cannabis used in non-therapeutic cannabis research involving human participants? If so, under what circumstances? What should the quality requirements be for cannabis derived from synthetic sources?
• 5. Should there be restrictions on the dosage, frequency, duration and route of administration (e.g. smoking or vaping) of cannabis used in non-therapeutic cannabis research involving human participants?
• 6. Should adverse reaction reporting for non-therapeutic cannabis research involving human participants be treated in a similar manner as adverse reaction reporting for clinical trials under the FDR? Why or why not?
• 7. What are your thoughts on expanding the production, distribution and sale activities of cannabis reference standards and test kits? What are the potential risks and benefits of this approach (e.g. by exempting reference standards from GPP requirements)?
• 8. Are there any impediments stemming from the current requirements for the “head of laboratory” under the CR?

PART 2: Feedback on additional regulatory issues

In addition to seeking input from interested stakeholders on Health Canada’s intent to propose amendments to the CR and associated regulatory frameworks to facilitate non-therapeutic cannabis research involving human participants and cannabis testing, Health Canada is also seeking input on the topics below. There are key questions after each topic for which Health Canada is particularly interested in receiving input. However, all input is welcome and should not be limited to responses to these questions. Please provide a rationale and/or evidence to support your views wherever possible. The responses will help inform potential future regulatory development and will be reviewed carefully by Health Canada.

Public possession limit

Under the Act, individuals 18 years of age and older are prohibited from possessing in public more than 30 grams of dried cannabis or its “equivalent” for non-dried forms of cannabis. Schedule 3 to the Act sets the amounts of various classes of cannabis that are considered equivalent to 1 gram of dried cannabis. These amounts generally align with U.S. jurisdictions that have legalized and regulated cannabis for non-medical purposes.

To help individuals comply with the public possession limit, the CR require that all cannabis products for retail sale, except for dried cannabis or a cannabis plant, be labelled with a statement indicating the amount of dried cannabis the product would be equivalent to (i.e. a public possession statement).

In public opinion research conducted in February 2020 by Health Canada, many participants were generally aware that there is a limit for the amount of cannabis that an adult can possess in public, however, very few were aware of what that limit actually is. The public possession statement on product labels was often misunderstood, and many participants in the public opinion research did not associate it with an indication of the public possession limit. Rather, this information was misinterpreted as either serving as a guide of product strength or as a benchmark enabling cost comparison between different cannabis products.

As well, some stakeholders have suggested that the public possession limits for non-solids containing cannabis (e.g. cannabis beverages) are too low, and that the public possession limits are encouraging consumers to purchase higher potency cannabis beverages.

• 9. Do you think the public possession statement on cannabis product labels helps adults comply with the public possession limit?
• 10. Currently, the CR require labels to display a statement to express the amount of cannabis a product is equivalent to in terms of grams of dried cannabis. Do you see any issues with this approach? Are there any benefits or challenges you think an adult may have in interpreting this information on different kinds of cannabis products (e.g. edible cannabis, cannabis topicals, vaping products, etc.)?
• 11. Do you think the current public possession limit for cannabis beverages (which is currently approximately 2 litres) should be increased? If yes, please explain what you think an appropriate public possession limit would be for these products and why.

Product labelling

Cannabis contains hundreds of chemical substances, including cannabinoids (such as tetrahydrocannabinol [THC] and cannabidiol [CBD]) and terpenes. The CR require that product labels indicate the quantity or concentration of the THC and CBD in cannabis products. Licence holders may choose to display the name, quantity or concentration of other cannabinoids and terpenes in the product, provided that the labelling and packaging comply with the CR.

• 12. Should Health Canada require product labels to display information about other cannabinoids and terpenes (e.g. quantity or concentration)? Why or why not? If yes, which cannabinoids and terpenes and why?
• 13. Is there any other labelling information that would help consumers make decisions to support informed and responsible use?

Micro class and nursery licences

The CR sets out a licensing framework intended to enable a diverse, competitive legal industry that is comprised of a range of market participants, including both small and large players.

Three of the licence subclasses — micro-cultivation, micro-processing, and nursery — are intended to enable the participation of small-scale players. The micro-cultivation and micro-processing licences authorize the same activities as a licence for standard cultivation and standard processing respectively, but at a smaller scale. The nursery licence is intended to enable a legal source of starting materials (both for commercial and personal cultivation), and the development of new varieties of high quality cannabis.

These licences are subject to reduced regulatory requirements (e.g. in the area of physical security), which reflects the level of risk related to the scale of the operation.

• 14. Are the regulatory requirements for the micro-cultivation, micro-processing and nursery licences (e.g. cultivation and processing limits) appropriate given their scale?
• 15. Are there any elements of the regulatory framework that put micro-cultivation, micro-processing and nursery licence holders at a competitive disadvantage compared to larger companies? If so, how, and what adjustments would you propose?

COVID-19 measures

Since April 2020, Health Canada has put in place measures to support cannabis licence holders with operational and logistical difficulties that they may be facing due to the COVID-19 pandemic. These include, among others, accepting a packaging date that is within four (4) days of the printed packaging date on the label (provided appropriate records are kept), enabling the destruction of cannabis to be witnessed virtually and simplifying the requirements for the presence of a security cleared person accompanying cannabis being treated at an external destruction or irradiation facility. These measures are in place until March 31, 2021.

• 16. Are there any measures that should be made permanent? What would be the impact if these measures were not continued? Are there any risks of making a measure permanent and how should they be mitigated?

Conclusion

The publication of this notice in the Canada Gazette, Part I, initiates a 30-day comment period. Health Canada is seeking feedback and comments to ensure that the proposed regulatory amendments with respect to cannabis research and testing are informed by and responsive to the cannabis industry, cannabis researchers, other relevant stakeholders and the public. The Department is also interested in views on a variety of other aspects related to the regulatory framework. Any inquiries or comments for this notice must be sent by email to cannabis.consultation@canada.ca stating the title of this notice (Notice of intent —Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues) in the subject line.

John Clare
Director General
Strategic Policy, Cannabis
Controlled Substances and Cannabis Branch

DEPARTMENT OF HEALTH

CONTROLLED DRUGS AND SUBSTANCES ACT
FOOD AND DRUGS ACT

Notice of intent to amend the Food and Drug Regulations and the Narcotic Control Regulations to restore potential access to restricted drugs through Health Canada’s Special Access Program

This notice provides interested parties and the general public with the opportunity to comment on Health Canada’s intention to reverse regulatory changes made to the Food and Drug Regulations (Parts C and J) and the Narcotic Control Regulations in 2013, which prohibited access to restricted drugs through the Special Access Program and added unauthorized products containing cocaine to the definition of restricted drug.

Background

The Controlled Drugs and Substances Act (CDSA) and its regulations provide a framework for the control of substances (also known as “controlled substances”) that can alter mental processes and that may produce harm to an individual or to society when misused or diverted to an illicit market. The CDSA prohibits any person from conducting activities (such as possession, production, sale, import and export) with controlled substances unless authorized by regulation or through an exemption granted under the CDSA. Regulations under the CDSA provide for the legitimate use of controlled substances, such as their use in approved prescription drugs. Under the CDSA, there are multiple different categories of controlled substances. Restricted drugs are controlled substances that are listed in the Schedule to Part J of the Food and Drug Regulations (FDR).^{footnote 1} Restricted drugs have no approved medical uses, and can only be used for scientific or research purposes.

Because of their biological effects, controlled substances also meet the definition of “drug” under the Food and Drugs Act (FDA), and are therefore also subject to the FDA. Under the FDA, the importation and sale of any drug is prohibited unless, subsequent to Health Canada’s established drug review and approval process, a Notice of Compliance has been issued or a Drug Identification Number (DIN) has been assigned. Access to drugs that have not yet been approved for sale in Canada can also be provided through an approved clinical trial or through Health Canada’s Special Access Program (SAP). Practitioners treating patients with serious or life-threatening conditions can request access to drugs that have not yet been approved for sale in Canada through the SAP when conventional therapies have failed, are unsuitable, or unavailable. Requests to the SAP are considered on a case-by-case basis, taking into consideration the level of scientific evidence (including evidence pertaining to safety, efficacy, and quality) to support the use of the drug for the treatment of the patient’s specific condition.

As a result of regulatory amendments made to the FDR in 2013, access to restricted drugs through the SAP is currently prohibited. The 2013 regulatory amendments included

• 1. Amending section C.08.010 of the FDR to prohibit access to restricted drugs through the SAP; and
• 2. Amending the definition of “restricted drug” in Part J of the FDR to include any cocaine products that are not otherwise authorized by Health Canada to be sold on the market, are not within the context of an approved clinical trial, or are not being compounded by a pharmacist by prescription.

While restricted drugs do not have approved medical uses, regulations under the CDSA allow for their use for scientific or research purposes, including their use in clinical trials.^{footnote 2} Since these regulatory changes were made in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has continued to advance. Certain restricted drugs are now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials.

As a result of the 2013 regulatory amendments, under the FDA, the only mechanism by which the sale of a restricted drug can be authorized for the treatment of patients is through participation in an approved clinical trial. While clinical trials remain the best mechanism to authorize the sale of restricted drugs (or any other unapproved drug) for the treatment of patients, there may be situations where a patient is unable to participate in one. For example, there may not be any clinical trials currently recruiting for a specific drug or in a specific area of the country. Based on recent scientific advancements and the potential for some restricted drugs to have therapeutic benefit, prohibiting the possibility of restricted drugs being authorized for sale through the SAP removes a potential option for practitioners treating patients with serious or life-threatening conditions in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Objective

As noted in the Regulatory Impact Analysis Statement for the 2013 regulatory amendments, the objective of those amendments was to prevent access to restricted drugs, heroin, and unauthorized products containing cocaine through Health Canada’s SAP. In 2016, these regulatory amendments were partially reversed, allowing for the consideration of applications made to the SAP for diacetylmorphine (i.e. heroin).

Based on recent scientific advancements and the potential for some restricted drugs to have therapeutic benefit, the objective of the current proposal is to restore the possibility of access to restricted drugs through Health Canada’s SAP, by reversing the remaining 2013 regulatory amendments. In practice, this would mean that practitioners could, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Proposal

Health Canada is proposing to reverse the remaining regulatory changes made in 2013, which would remove the current prohibition on access to restricted drugs through the SAP, and would also remove unauthorized products containing cocaine from the definition of restricted drugs.

Removing the prohibition on access to restricted drugs through the SAP

More specifically, Health Canada proposes to repeal subsections C.08.010 (3) and C.08.011.1 (2) in Part C of the FDR, which prohibit the issuance of letters of authorization to a manufacturer for any drug that is or that contains a restricted drug.

Subsections C.08.010 (3) and C.08.011.1 (2) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.^{footnote 3}

Reversing the remaining 2013 regulatory amendments would not guarantee that restricted drugs would be approved through the SAP, but it would treat restricted drugs like all other controlled substances for the purposes of the SAP. As is currently the case, all applications to the SAP would be considered on a case-by-case basis, taking into consideration the level of evidence pertaining to the safety, efficacy, and quality of the drug, as well as the particular needs of the patient. The proposed amendments are not intended to promote or encourage the early use of unapproved drugs, or to circumvent the well-established clinical trial or drug review and approval processes. These amendments could, however, provide an additional potential option for practitioners treating patients with serious or life-threatening conditions in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Removing unauthorized products containing cocaine from the definition of restricted drug

Since 2013, cocaine has been regulated under two different regulations under the CDSA. Any cocaine products that have been authorized by Health Canada to be sold on the market, that are being used within the context of an approved clinical trial, or that are being compounded by a pharmacist pursuant to a prescription are regulated as narcotics, whereas unauthorized products containing cocaine are regulated as restricted drugs.

To simplify regulatory requirements and facilitate compliance with the regulations, Health Canada proposes to reverse the 2013 amendments related to cocaine by

• 1. Repealing part (b) of the definition for restricted drug in section J.01.001 of Part J of the FDR.
  • (b) cocaine (benzoylmethylecgonine) or any of its salts, or a product or compound that contains such a substance, except
    • (i) a drug in dosage form, as defined in subsection C.01.005(3), that has a drug identification number assigned to it under Division 1 of Part C or that is authorized for sale under Division 5 of Part C, and
    • (ii) cocaine (benzoylmethylecgonine) or any of its salts, or a preparation that contains such a substance, that is prepared by a pharmacist in accordance with or in anticipation of a prescription.
• 2. Repealing the exception in subsection 2(2) of the Narcotic Control Regulations, which excludes the above-noted forms of cocaine from the application of the Narcotic Control Regulations.
• 3. Repealing the definitions for “pharmacist” and “prescription,” which were added to Part J of the FDR in 2013 to support the amendments made to part (b) of the definition of restricted drug.

Public comments

The publication of this notice of intent in the Canada Gazette, Part I, initiates a 60-day comment period that will end on February 10, 2021. If you are interested in participating in this consultation, please send written comments to the Office of Legislative and Regulatory Affairs, Controlled Substances Directorate, Controlled Substances and Cannabis Branch, Health Canada. Comments can be sent by email to hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca, or by mail to the Office of Legislative and Regulatory Affairs, Address Locator: 0302A, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9.

Michelle Boudreau
Director General
Controlled Substances Directorate
Controlled Substances and Cannabis Branch

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)

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

Therefore, the Minister of Health, pursuant to subsection 30.1(1)^{footnote a} of the Food and Drugs Act^{footnote b}, makes the annexed Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).

Ottawa, November 27, 2020

Patricia Hajdu
Minister of Health

Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)

Interpretation

1 The following definitions apply in this Interim Order.

drug

means any of the following drugs that is for human use and for which a drug identification number has been assigned under the Food and Drug Regulations or the ISAD Interim Order:

• (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act;
• (b) prescription drugs, as defined in section A.01.010 of the Food and Drug Regulations;
• (c) drugs that are listed in Schedule C or D to the Food and Drugs Act; and
• (d) drugs that are permitted to be sold without a prescription, as defined in subsection C.01.001(1) of the Food and Drug Regulations, but that are to be administered only under the supervision of a practitioner, as defined in that subsection. (drogue)

establishment licence

means an establishment licence issued under subsection C.01A.008(1) of the Food and Drug Regulations. (licence d’établissement)

ISAD Interim Order

means the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 made by the Minister on September 16, 2020 and published in Part I of the Canada Gazette on October 3, 2020. (arrêté d’urgence IVPD)

manufacturer

means

• (a) in respect of a drug for which an authorization has been issued under the ISAD Interim Order, the person that holds the authorization; and
• (b) in respect of any other drug, the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug. (fabricant)

shortage,

in respect of a drug, means a situation in which the manufacturer is unable to meet the demand for the drug in Canada. (pénurie)

Prohibition

2 A person that holds an establishment licence must not distribute a drug to another person for consumption or use outside Canada unless the person holding the licence has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.

Obligations — record

3 If a person that holds an establishment licence distributes a drug to another person for consumption or use outside Canada, the person holding the licence must immediately create — and retain — a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section 2.

Information request

4 (1) The Minister may request that the manufacturer of a drug — or any person that holds an establishment licence in respect of a drug — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

• (a) there is a shortage of the drug or the drug is at risk of going into shortage;
• (b) the information is necessary to establish or assess
  • (i) the existence of a shortage or risk of shortage of the drug,
  • (ii) the reasons for a shortage or risk of shortage of the drug,
  • (iii) the effects or potential effects on human health of a shortage of the drug, or
  • (iv) measures that could be taken to prevent or alleviate a shortage of the drug; and
• (c) the manufacturer or person will not provide the information without a legal obligation to do so.

Obligation to provide information

(2) The manufacturer or person must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit must be at least 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Deeming

5 The references to the Food and Drug Regulations in paragraphs C.01A.016(1)(a) and (2)(a) of those Regulations are deemed to include a reference to this Interim Order.

EXPLANATORY NOTE

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

Proposal

The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) [the Interim Order] made by the Minister of Health on November 27, 2020, introduces new measures to help safeguard the Canadian drug supply by ensuring that bulk importation frameworks, such as the one recently established by the United States, do not cause or exacerbate a drug shortage in Canada. The Interim Order also enables the Minister to require a seller to provide information that could help Health Canada take steps to assess or alleviate an existing or potential drug shortage.

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

Objective

The objective of the Interim Order is to help safeguard the Canadian drug supply by ensuring that bulk importation frameworks, such as the one recently established by the United States, do not cause or exacerbate a drug shortage in Canada.

Background

Drug shortages are a growing global problem with particular implications for vulnerable markets like Canada. Since 2017, approximately 10–15% of drugs have been in shortage at any given time. Canada is a small market representing 2% of global drug sales that sources 68% of its drugs internationally.

The COVID-19 pandemic has made this situation worse by disrupting the availability of drugs and by causing an increase in the demand for certain medicines used to treat and manage COVID-19 infections. By October 20, 2020, Canada had experienced 42 Tier 3 (highest impact) shortages, compared to approximately 10 such shortages in all of 2019. While the supply and demand levels for many drugs are stabilizing, the need for vigilance in maintaining the national drug supply continues, and the Government remains focused on preparing a strong response to a future resurgence of COVID-19.

Drug shortages have a real impact on Canadians. Health care providers rely on access to needed drugs to provide proper and timely treatment. Drug shortages can contribute to adverse patient outcomes, such as delayed or cancelled surgeries, less than optimal care because of the need to use alternative treatments, discontinued treatment where there is no alternative, and drug rationing.

Drug shortages affect all gender and sociodemographic groups in Canada and can have serious impacts on the health care system, causing harm to Canadians. Already vulnerable populations, such as children, older adults, and Indigenous populations may be disproportionately affected by a drug shortage. Canada requires access to a diverse supply of drugs to protect the health and safety of Canadians.

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

To date, the federal government has put in place a number of temporary measures to support efforts to alleviate shortages that occur and to help prevent new shortages. For example, the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health (the Minister) on March 30, 2020, permits the exceptional importation of specified drugs that may not fully meet Canadian regulatory requirements, but are manufactured according to comparable standards, to help alleviate a shortage. Also, the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, made by the Minister on October 16, 2020, provides the Minister with additional tools to address drug shortages. These tools include, but are not limited to, the ability to request specific shortage-related information from those who sell drugs to help prevent or alleviate drug shortages that may be caused or exacerbated by the COVID-19 pandemic. Both of these interim orders were approved by the Governor in Council and are in effect for one year from the date they were made.

These measures provide additional tools to help the Minister address drug shortages. However, they can be used only within the context of COVID-19. New tools are needed to address additional pressures to the Canadian drug supply that increase the risk of drug shortages.

On October 1, 2020, the United States (U.S.) published the final rule on the Importation of Prescription Drugs. The rule comes into effect on November 30, 2020, and creates a pathway to allow licensed U.S. pharmacists or wholesalers to import in bulk certain prescription drugs intended for the Canadian market. There has been significant state-level support for the bulk importation of drugs from Canada. The implementation of importation programs would worsen the existing problem of drug shortages in Canada and put the health of Canadians at risk.

Urgent action is required to put in place tools that help ensure that any participation in bulk importation programs in the United States or in other countries do not cause or exacerbate drug shortages.

Implications

The Interim Order prohibits a drug establishment licence (DEL) holder (e.g. a fabricator, wholesaler, or distributor) from distributing certain drugs intended for the Canadian market to another person (i.e. individual or business) for consumption or use outside Canada, unless the DEL holder has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage. This Interim Order applies to all distribution conducted by DEL holders and is focused on drugs for which a shortage would have the highest impact on patient health and safety (e.g. prescription drugs, controlled substances and biologics). The prohibition does not apply to sales made by a person who is not required to hold a DEL (e.g. consumer-level pharmacy) and does not include transfers of drugs within a company. Sales of products manufactured in Canada solely for export are also not included in the scope of the prohibition as long as the conditions for exempt exports, as outlined in subsection 37(1) of the Food and Drugs Act, are met.

A shortage is where, in respect of a drug, a manufacturer is unable to meet the demand for the drug in Canada. The Interim Order does not prohibit the distribution of a drug for consumption outside of Canada if the DEL holder is able to demonstrate that the sale will not cause or exacerbate a shortage. DEL holders are required to maintain a record of this determination. Information about making the determination of whether a sale will cause or exacerbate a shortage has been provided in the guidance document on the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).

This Interim Order also introduces a new authority for the Minister to require specific information from certain persons to assess existing and potential shortages. This authority to require information has some degree of overlap with the authority in the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, but there are three key differences. First, the Interim Order is limited to regulated parties holding a drug product authorization or establishment licence issued by Health Canada, as opposed to all persons who sell a drug. Second, it applies to all shortages, not only those related to COVID-19 or bulk exportation. Third, the scope of this Interim Order does not include over-the-counter drugs. The authority within this Interim Order provides the Minister with the ability to gather information about a shortage or potential shortage when voluntary compliance with a request for information is not achieved. This information will better inform decision-making and federal interventions to help manage drug shortages.

A person required to provide information must do so electronically in a format acceptable to the Minister. The required information is to be submitted within the time frame specified by the Minister. However, the Minister cannot require the information to be submitted with less than 24 hours’ notice, unless the Minister has reasonable grounds to believe that there is a serious or imminent health risk. Further information on the process for providing information and more details about the types of information that may be requested has been provided to industry through the guidance document on the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).

Enforcement of this Interim Order takes place through inspection, compliance promotion, monitoring, and verification. Health Canada will continue to conduct compliance promotion sessions with DEL holders to increase their understanding of their new obligations and minimize non-compliance. Health Canada has a number of enforcement powers available to address non-compliance with the Food and Drugs Act, or an issue of public health and safety. Actions that could be taken against DEL holders violating the terms of the Interim Order include requesting a plan for corrective measures, issuing public advisories or other forms of communication, or suspending or cancelling of the DEL holder’s licence.

Health Canada will choose the most appropriate tool to help ensure compliance and to mitigate any risks to health, informed by the specifics of each case and in alignment with the Compliance and enforcement policy framework and the Compliance and enforcement policy for health products (POL-0001). In instances where Health Canada’s responses have been appropriately escalated, but have still not successfully achieved compliance, Health Canada may make a recommendation for prosecution to the Public Prosecution Service of Canada.

Consultation

Comments received from industry and health interest groups to date are supportive of the government of Canada taking immediate action to address the risk of drug shortages presented by the U.S. rule. Since the release of the U.S. Safe Importation Action Plan on July 31, 2019, Health Canada has heard from many Canadians who voiced their concern regarding prescription drug importation proposals from foreign countries and their expectation that the Government take definitive action to safeguard Canada’s drug supply.

Stakeholder consultation on specific aspects of this Interim Order was not possible, since the U.S. final rule was only recently published and because of the urgent nature of the risks to the Canadian drug supply. However, in 2019 and earlier in 2020, Health Canada consulted with industry and the broader health care community on the importance of preventing bulk exports of drugs that could cause or exacerbate drug shortages in Canada. Stakeholders in the medical, nursing, pharmacy, and charitable communities were strongly supportive of efforts to prevent bulk exports of drugs intended for the Canadian market.

Contact

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Regions Branch
Health Canada
Address Locator: 1907A
200 Eglantine Driveway
Jeanne Mance Building
7th Floor, Room 705A
Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 613‑946‑6220
Email: hc.prsd-questionsdspr.sc@canada.ca

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of intent — Proposal to reduce the record retention period for clinical trials of drugs involving human subjects

The purpose of this notice is to inform interested stakeholders of Health Canada’s proposed policy direction and intent to amend the Food and Drug Regulations and the Natural Health Products Regulations under the Food and Drugs Act to reduce the record retention period for clinical trials of drugs involving human subjects from 25 to 15 years. Health Canada intends to use stakeholder feedback received from this notice to confirm that the proposed amendments reflect stakeholder needs, while still offering an appropriate level of protection for Canadians.

Background

Canada is recognized globally for the quality and expertise of its research clinicians. Many are known worldwide for major medical discoveries and innovations as well as for their ability to conduct clinical research in complex therapeutic areas with diverse populations.

Canada’s competitiveness in clinical trials depends on a number of factors such as its world-leading higher education system, a publicly funded health care system known for quality, national networks and health charities dedicated to clinical trials, and government investments in research infrastructure. Underpinning these factors is a regulatory framework that favourably compares to those of other jurisdictions and minimizes costs to conduct clinical trials, when possible, while maintaining proper oversight to protect the health and safety of Canadians.

Under Division 5 of the Food and Drug Regulations and Part 4 of the Natural Health Products Regulations, sponsors of clinical trials are required to maintain all records referred to in the respective regulations for 25 years. This time frame was introduced into the Food and Drug Regulations in 2001 when the current clinical trial framework for drugs involving human subjects was introduced in Division 5 of Part C. The retention period aligned with industry standards of that time. These same requirements were included in the Natural Health Products Regulations when the Regulations were made in 2004. This record retention period allowed for subject follow-up throughout the subsequent stages of drug development, assessment, and marketing, as well as provided the ability to assess the impact on the next generation.

Through the years, both international and industry standards have evolved to the current situation where the 25-year time frame is no longer considered appropriate. Reducing burden and aligning with regulatory partners would create a more level playing field for the Canadian clinical trials sector, where the sector can better compete to attract more clinical trials to Canada.

Consultations

Stakeholders identified that the 25-year record retention requirement is overly burdensome and not aligned with that of other jurisdictions, such as the United States, or with international best practices as part of the consultations conducted in 2017–2018 to inform the Guidance Document – Part C, Division 5 of the Food and Drug Regulations, “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100). Similar concerns were raised again by stakeholders during consultations conducted through the targeted sectoral regulatory review of the health and biosciences sector.

Stakeholder support for the proposed amendments is anticipated given feedback received in the above-mentioned consultations. Further targeted consultations are scheduled to occur beginning in mid-December 2020.

Proposed changes

Health Canada is proposing to make targeted amendments to the Food and Drug Regulations (C.05.012) as well as to the Natural Health Products Regulations (section 76), to reduce the record retention period from 25 to 15 years, and is exploring certain exceptions.

Proposed exception

In the case of clinical trials involving participants under the age of 18, it is proposed that a record retention period greater than 15 years would be required. This proposed exception would provide protection to the federal government, clinical trials sponsors and physicians from liability over malpractice and aim at addressing the elevated long-term risks posed by clinical trials involving younger participants.

Provincial and territorial laws or regulations

This proposal would not limit any provincial or territorial law or regulation, including any professional regulations enacted in accordance with a provincial or territorial enabling statute as part of the practice of medicine that may require longer record retention time frames.

Additional considerations

The proposed amendments support the Government of Canada’s commitment to modernize federal regulations to support business growth in Canada, while continuing to protect the health and safety of Canadians. The proposal also aligns with Canada’s Innovation Agenda by improving the clinical research environment. As recommended by Canada’s Economic Strategy Tables and reiterated in the 2018 Fall Economic Statement (Chapter 3), reducing any unnecessary regulatory burden would improve Canada’s competitiveness and ability to attract businesses and investments in clinical trials.

Overall, reducing the duration of the clinical trial record retention period would contribute to reducing the administrative burden on clinical trial sponsors and investigators conducting studies, and the cost of conducting clinical trials. Reducing the record retention period below 25 years would better align Health Canada with international regulatory partners, and could provide an incentive to develop more innovative drugs in Canada. These proposed regulatory amendments are not expected to impact the health, safety, or security of patients, or their ability to make informed choices.

Next steps

Health Canada plans to seek an exemption from prepublication in the Canada Gazette, Part I, depending on stakeholder support. Health Canada anticipates final publication of the regulatory amendments in the Canada Gazette, Part II, in fall 2021, if an exemption from prepublication is granted. Results of this consultation will also be used to help inform the record retention requirements for the regulatory proposal to transition the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19.

Public comment period

Interested parties may, within 45 days of publication of the notice, that is until Monday, January 25, 2021, provide their comments on this notice of intent in writing, in English or in French, to the following address: Catherine Hudon, Director, Compliance Policy and Regulatory Affairs, Policy and Regulatory Strategies Directorate, 200 Eglantine Driveway, Ottawa, Ontario K1A 0K9. Comments can also be sent by email to hc.prsd-questionsdspr.sc@canada.ca.

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following person of the Guelph Police Service as a fingerprint examiner:

• Brandy Henderson

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following person of the Lethbridge Police Service as a fingerprint examiner:

• Christopher James Robinson

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following persons of the Royal Canadian Mounted Police as fingerprint examiners:

• Alison Cameron
• Evelyn Hui
• Larry Kobylanski
• Tommy Thifault
• Jeff Wong

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following persons of the Sault Ste. Marie Police Service as fingerprint examiners:

• Shawn Cyr
• Katherine McCoy

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following person of the Thunder Bay Police Service as a fingerprint examiner:

• Patrick Willson

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Revocation of designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby revoke the designation of the following persons of the Saskatoon Police Service as fingerprint examiners:

• Leslie van den Beuken
• Laura Evenson

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Revocation of designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby revoke the designation of the following person of the Sault Ste. Marie Police Service as a fingerprint examiner:

• Norm Payeur

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Revocation of designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby revoke the designation of the following person of the Thunder Bay Police Service as a fingerprint examiner:

• Jesse Lepere

Ottawa, November 20, 2020

Trevor Bhupsingh
Acting Assistant Deputy Minister
Community Safety and Countering Crime Branch

PRIVY COUNCIL OFFICE

Appointment opportunities

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

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

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

Current opportunities

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

Governor in Council appointment opportunities

Position	Organization	Closing date
Member	Atlantic Pilotage Authority Canada
President and Chief Executive Officer	Atomic Energy of Canada Limited
Commissioner	British Columbia Treaty Commission
Member	Buffalo and Fort Erie Public Bridge Authority
Director	Business Development Bank of Canada
Director — Board Risk Committee Chairperson	Business Development Bank of Canada
President and Chief Executive Officer	Business Development Bank of Canada
President and Chief Executive Officer	Canada Development Investment Corporation
Commissioner for Employers	Canada Employment Insurance Commission
President and Chief Executive Officer	Canada Lands Company Limited
President	Canada Mortgage and Housing Corporation
Member of the Board of Directors	Canada Post
President	Canadian Commercial Corporation
Member	Canadian Cultural Property Export Review Board
Commissioner (full-time), Commissioner (part-time)	Canadian Energy Regulator
Director	Canadian Energy Regulator
Chief Commissioner	Canadian Grain Commission
Commissioner	Canadian Grain Commission
Federal Housing Advocate	Canadian Human Rights Commission
Member	Canadian Human Rights Tribunal
Chairperson	Canadian International Trade Tribunal
Chairperson	Canadian Museum of History
Director	Canadian Museum of History
Permanent Member	Canadian Nuclear Safety Commission
Chairperson	Canadian Transportation Agency
Temporary Member	Canadian Transportation Agency
Chief Administrator	Courts Administration Service
Director	Farm Credit Canada
Chairperson	Federal Public Sector Labour Relations and Employment Board
Vice-Chairperson	Federal Public Sector Labour Relations and Employment Board
Director	Freshwater Fish Marketing Corporation
Chairperson	Great Lakes Pilotage Authority Canada
Director (Federal)	Hamilton-Oshawa Port Authority
Member, Northwest Territories	Historic Sites and Monuments Board of Canada
Assistant Deputy Chairperson	Immigration and Refugee Board of Canada
Commissioner	Impact Assessment Agency of Canada
Member (appointment to roster)	International Trade and International Investment Dispute Settlement Bodies
Chairperson	The Jacques Cartier and Champlain Bridges Incorporated
Chairperson	Laurentian Pilotage Authority Canada
Chairperson	Military Police Complaints Commission of Canada
Member	Military Police Complaints Commission of Canada
Director (Federal)	Nanaimo Port Authority
Member	National Arts Centre Corporation
Secretary	National Battlefields Commission
Member	National Seniors Council
Member	Natural Sciences and Engineering Research Council of Canada
Member	Payments in Lieu of Taxes Dispute Advisory Panel
Director	Public Sector Pension Investment Board
Commissioner	Roosevelt Campobello International Park Commission
Member	Social Sciences and Humanities Research Council of Canada
President	Social Sciences and Humanities Research Council of Canada
Registrar	Supreme Court of Canada
Member	Telefilm Canada
Chairperson and Member	Transportation Appeal Tribunal of Canada
Member	Transportation Appeal Tribunal of Canada
Vice-Chairperson	Transportation Appeal Tribunal of Canada