Regulations Amending Certain Regulations Made Under the Canada Labour Code (Medical Devices, COVID-19): SOR/2021-140

Canada Gazette, Part II, Volume 155, Number 14

Registration
SOR/2021-140 June 17, 2021

CANADA LABOUR CODE

P.C. 2021-582 June 17, 2021

His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Labour, the Minister of Transport, the Minister of Indigenous Services and the Minister of Natural Resources, pursuant to section 157 footnote a of the Canada Labour Code footnote b, makes the annexed Regulations Amending Certain Regulations Made Under the Canada Labour Code (Medical Devices, COVID-19).

Regulations Amending Certain Regulations Made Under the Canada Labour Code (Medical Devices, COVID-19)

Canada Occupational Health and Safety Regulations

1 (1) Section 12.13 of the Canada Occupational Health and Safety Regulations footnote 1 is amended by adding the following after subsection (1):

(1.1) Despite paragraph (1)(a), if there is a risk of injury or disease due to exposure to an airborne hazardous substance, other than a CBRN agent, in a work place and a person’s presence is determined by a qualified person to be necessary for medical treatment to be provided at the work place, under supervision from a health care practitioner as defined in section 166 of the Canada Labour Code, the employer may provide respiratory protection equipment that is a COVID-19 medical device authorized for sale by the Minister of Health under the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 made on March 1, 2021 and published in the Canada Gazette, Part I on March 20, 2021 and that meets the requirements set out in paragraphs (1)(b) and (c) and subsection (4).

(2) Subsection 12.13(1.1) of the Regulations is repealed.

Oil and Gas Occupational Safety and Health Regulations

2 (1) Subsection 13.7(1) of the Oil and Gas Occupational Safety and Health Regulations footnote 2 is replaced by the following:

13.7 (1) Subject to subsection (4), where there is a hazard of an airborne hazardous substance or an oxygen deficient atmosphere in a work place, the employer shall provide a respiratory protective device that is listed in the NIOSH Certified Equipment List as of October 1, 1984, dated February 1985, published by the United States National Institute for Occupational Safety and Health, or, where there is a hazard of an airborne hazardous substance in a work place and a person’s presence is determined by a qualified person to be necessary for medical treatment to be provided at the work place, under supervision from a health care practitioner as defined in section 166 of the Canada Labour Code, the employer may provide a respiratory protective device that is a COVID-19 medical device authorized for sale by the Minister of Health under the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 made on March 1, 2021 and published in the Canada Gazette, Part I on March 20, 2021.

(2) Subsection 13.7(1) of the Regulations is replaced by the following:

13.7 (1) Subject to subsection (4), where there is a hazard of an airborne hazardous substance or an oxygen deficient atmosphere in a work place, the employer shall provide a respiratory protective device that is listed in the NIOSH Certified Equipment List as of October 1, 1984, dated February 1985, published by the United States National Institute for Occupational Safety and Health.

On Board Trains Occupational Health and Safety Regulations

3 (1) Subsection 8.8(1) of the On Board Trains Occupational Health and Safety Regulations footnote 3 is replaced by the following:

8.8 (1) If there is a hazard of an airborne hazardous substance or an oxygen deficient atmosphere in a work place, the employer shall provide a respiratory protective device that is listed in the United States National Institute for Occupational Safety and Health publication entitled Certified Equipment List, as amended from time to time, or, if there is a hazard of an airborne hazardous substance in a work place and a person’s presence is determined by a qualified person to be necessary for medical treatment to be provided, under supervision from a health care practitioner as defined in section 166 of the Canada Labour Code, at the work place, the employer may provide a respiratory protective device that is a COVID-19 medical device authorized for sale by the Minister of Health under the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 made on March 1, 2021 and published in the Canada Gazette, Part I on March 20, 2021.

(2) Subsection 8.8(1) of the Regulations is replaced by the following:

8.8 (1) If there is a hazard of an airborne hazardous substance or an oxygen deficient atmosphere in a work place, the employer shall provide a respiratory protective device that is listed in the United States National Institute for Occupational Safety and Health publication entitled Certified Equipment List, as amended from time to time.

Maritime Occupational Health and Safety Regulations

4 (1) Subsection 142(1) of the Maritime Occupational Health and Safety Regulations footnote 4 is replaced by the following:

142 (1) If there is a hazard of an airborne hazardous substance or an oxygen-deficient atmosphere in a work place, the employer must provide a respiratory protective device or breathing apparatus that is listed in the most recent version of the NIOSH Certified Equipment List, or, if there is a hazard of an airborne hazardous substance in a work place and a person’s presence is determined by a qualified person to be necessary for medical treatment to be provided, under supervision from a health care practitioner as defined in section 166 of the Canada Labour Code, at the work place, the employer may provide a respiratory protective device that is a COVID-19 medical device authorized for sale by the Minister of Health under the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 made on March 1, 2021 and published in Canada Gazette, Part I on March 20, 2021.

(2) Subsection 142(1) of the Regulations is replaced by the following:

142 (1) If there is a hazard of an airborne hazardous substance or an oxygen-deficient atmosphere in a work place, the employer must provide a respiratory protective device or breathing apparatus that is listed in the most recent version of the NIOSH Certified Equipment List.

Coming into force

5 (1) Subject to subsection (2), these Regulations come into force on the day on which they are registered.

(2) Subsections 1(2), 2(2), 3(2) and 4(2) come into force on the day on which the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ceases to have effect.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The Labour Program of Employment and Social Development Canada (the Labour Program) seeks to promote and sustain stable industrial relations and safe, fair, healthy, equitable and productive work places within the federal jurisdiction. Part II (Occupational Health and Safety) of the Canada Labour Code (the Code), and the regulations made under that Part, set requirements to, among other things, protect all persons granted access to the work place from airborne hazardous substances by requiring the use of personal protective equipment in federally regulated work places. These requirements, which are set out in a number of occupational health and safety regulations (OHS Regulations) made under the Code, include requirements for all persons granted access to the work place to be provided a respirator certified by the United States National Institute for Occupational Safety and Health (NIOSH) in situations where there is a risk of airborne hazardous substances.

The availability of NIOSH-certified respirators has decreased due to the COVID-19 pandemic. Canada has been challenged to meet the demand for NIOSH-certified medical respiratory devices for health care workers who may be in direct contact with potential or confirmed COVID-19 patients, and other workers.

Currently, NIOSH standards for respirators are embedded in federal and provincial/territorial regulations and acts. While Canadian manufacturers in British Columbia, Alberta, Ontario and Quebec are continuing to produce respiratory protective devices, most do not comply with the respiratory protection provisions under the OHS Regulations.

To compensate for supply chain issues and to provide an alternative to NIOSH-certified respirators, the Minister of Health issued Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (Interim Order No. 2), authorizing certain medical respiratory devices for medical use. Under Interim Order No. 2, Health Canada publishes a list of authorized COVID-19 medical devices online, which is updated regularly.

To promote adequate supply of respiratory protective devices for employers and all persons granted access to a work place under federal jurisdiction, amendments are needed to the OHS Regulations to allow the option to use COVID-19 medical devices for respiratory protection, authorized under Interim Order No. 2, in work places where medical treatment is being provided, under supervision from a health care practitioner.

Background

Manufacturers must continuously seek NIOSH certification for every new lot of products produced. During the COVID-19 pandemic, NIOSH initially ceased certifying new products and only restarted this work as of February 2021. Since restarting certification, NIOSH has been focusing on applications for certification from American manufacturers in the United States (U.S.). In April 2021, a company based out of the U.S. was able to commence manufacturing NIOSH-certified respirators at a location in Ontario. No other domestic manufacturing of NIOSH-certified respirators has restarted in Canada and the importation of such devices is variable and unstable.

Recently, the supply situation has improved and there is increased availability of NIOSH-certified respirators on the market, albeit available for shipping in small volumes. Domestic suppliers are prioritizing the health care sector before supplying respirators more broadly. Notwithstanding this change in the supply situation, respirators remain in high demand in the health care sector and securing and maintaining necessary volumes of products will remain a challenge for the near future.

NIOSH certification alone does not meet all the requirements of the OHS Regulations under the Code. The regulations require organizations to fit test these products, which is not a requirement in the NIOSH certification process. Fit testing consists of a qualitative or quantitative test that measures the effectiveness of the seal between the user’s face and the respirator. Fit testing must be conducted initially and regularly by a qualified individual. After fit testing the products cannot be reused. At times, several models will have to be tested before an acceptable fit is achieved. So, although some NIOSH-certified respirators may be available, the appropriate model and sufficient quantity may pose a serious threat to an employer’s ability to meet their obligations under the OHS Regulations.

Requirements embedded in local, provincial/territorial and federal guidelines, regulations and legislation can have significant and immediate implications for the availability of NIOSH-certified respiratory protective devices in Canada. Although public health guidelines are independent from, and not incorporated into, OHS Regulations under the Code, these types of varying requirements can have a detrimental domino effect on a fragile supply chain. Increased health care sector demand for supply of fit tested products (models already in use within their health care system) subsequently delays deliveries to non-health care sectors as suppliers continue to prioritize health care sector contracts, a situation which left some employers struggling to find supply of respirators for their work places since the onset of the COVID-19 pandemic.

Objective

The objectives of these amendments are to support a coordinated response to the COVID-19 pandemic, to promote compliance with OHS Regulations in federal jurisdiction work places where medical treatment is being provided under supervision from a health care practitioner, and to provide an alternative option to protect against airborne hazardous substances.

Description

The Regulations Amending Certain Regulations Made Under the Canada Labour Code (Medical Devices, COVID-19) [the Regulations] will amend four OHS Regulations:

The Regulations amend the respiratory protection provisions in the specified OHS Regulations to state that, where there is a risk of an airborne hazardous substance in a work place, and a person’s presence is determined by a qualified person to be necessary for medical treatment to be provided at the work place, under supervision from a health care practitioner, the employer may provide a COVID-19 medical device for respiratory protection authorized under Interim Order No. 2 rather than a NIOSH-certified respiratory protective device.

The Regulations will be repealed on the day on which Interim Order No. 2 ceases to have effect.

Regulatory development

Consultation

Consultations on providing an alternative to NIOSH certification were undertaken with stakeholders, including

Overall, consultations with stakeholders demonstrated support for this regulatory amendment. Stakeholders were in agreement that this amendment will alleviate pressures related to the acquisition of NIOSH-certified respirators, while also protecting the domestic supply chain. The following are key highlights that emerged from consultations with stakeholders:

Health Canada, the Public Health Agency of Canada, Transport Canada, Natural Resources Canada, Indigenous Services Canada, Global Affairs Canada, Crown-Indigenous Relations and Northern Affairs Canada, and the Canada Energy Regulator were consulted throughout the regulatory process.

There is a pressing need to provide an alternative option to NIOSH-certified respiratory protective devices due to the supply chain challenges presented by the COVID-19 pandemic and to protect persons in federal jurisdiction work places where medical treatment is being provided, under supervision from a health care practitioner. Therefore, the Regulations were exempted from prepublication in the Canada Gazette, Part I.

Modern treaty obligations and Indigenous engagement and consultation

The Regulations might be applicable to all persons granted access to the work place requiring devices for respiratory protection in federal jurisdiction work places where medical treatment is being provided under supervision from a health care practitioner within modern treaty areas, dependent on specific activities within their territory.

The Labour Program conducted the assessment of modern treaty implications (AMTI). The AMTI indicates that the amendments will not change which work places are under federal jurisdiction and are subject to provisions under the Code. Indigenous bands and band councils are generally subject to the Code, including those with modern treaties or self-government status.

The Code continues to apply to modern treaty areas, as this area of jurisdiction has been “carved out” of areas of jurisdiction in treaties, meaning that it is not an area of jurisdiction for which a modern treaty holder would create their own legislation. Modern treaty holders would therefore apply the Code to applicable activities in their territory.

Instrument choice

Providing an alternative to NIOSH-certified respirators could only be accomplished through amendments to the OHS Regulations. Therefore, no other instruments were available to implement these changes.

Regulatory analysis

Benefits and costs

No incremental costs are anticipated for federal jurisdiction employers as a result of the regulatory amendments. Under the baseline scenario, employers are required to provide NIOSH-certified respirators to every person granted access to their work place where there is a risk of an airborne hazardous substance. Under the regulatory scenario, this continues to be the case, however, employers also have the option of providing COVID-19 medical devices for respiratory protection authorized under Interim Order No. 2, under certain circumstances. As an employer has the option to continue to provide NIOSH-certified respirators in addition to a COVID-19 medical device under the regulatory scenario, it is assumed that compliance costs for employers under the regulatory scenario will not be more than they would be under the baseline scenario.

The benefits of the Regulations come from the additional flexibility provided under the regulatory scenario, which provides employers with an additional option to achieve compliance with the OHS Regulations without compromising the health and safety of persons granted access to the work place. Employers may also benefit from decreased costs due to an increased availability of respirators that meet the requirements of the Regulations.

Persons granted access to federal jurisdiction work places where there is a risk of an airborne hazardous substance are expected to be provided comparable respiratory protection under both the baseline and regulatory scenarios. The devices authorized under Interim Order No. 2 are safe, effective and respect quality standards comparable to NIOSH in providing respiratory protection while providing medical treatment under supervision from a health care practitioner. The devices are manufactured to meet similar criteria as those certified through NIOSH with a specific focus on testing for use in medical environments. Therefore, devices are expected to provide effective protection against the risk of an airborne hazardous substance in certain circumstances.

Neither Health Canada nor the Labour Program will incur additional costs as a result of the Regulations.

Small business lens

The small business lens applies to the Regulations. The Regulations provide all federal jurisdiction employers, including small businesses, with an alternative to providing NIOSH-certified respiratory protective devices, under certain circumstances. This may increase access to approved devices, thereby decreasing compliance costs, especially for small businesses that typically use fewer devices and may experience increased hardship accessing NIOSH-certified respirators during the COVID-19 pandemic.

One-for-one rule

The one-for-one rule does not apply to this initiative, as there is no change in administrative costs to businesses.

Regulatory cooperation and alignment

The Regulations are aligned with corresponding approaches currently in force across many Canadian provinces and territories. Alberta, British Columbia, Ontario and Quebec have adopted policy changes or amended regulations, in alignment with Interim Order No, 2, to allow devices not certified by NIOSH to be used in provincially regulated establishments.

The Regulations support a coordinated response to the impacts of the COVID-19 pandemic. Ultimately, the amendments allow an alternative for federal jurisdiction employers to provide a COVID-19 medical device as authorized by Interim Order No. 2 for persons whose presence is determined by a qualified person to be necessary to provide medical treatment at the work place under supervision from a health care practitioner. The Minister of Health will remain responsible for the authorization of these medical devices based on specific standards, both Canadian and international, as specified within Interim Order No. 2.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required, as there are no broader environmental impacts.

Gender-based analysis plus

In accordance with the guidance on conducting a gender-based analysis plus (GBA+), a preliminary assessment concluded that no groups would be disproportionately impacted based on factors such as gender identity, sex, age, language, education, geography, culture, ethnicity, income, ability or sexual orientation.

Implementation and compliance and enforcement

Implementation

The Regulations will come into force on the day on which they are registered.

Compliance and enforcement

Compliance with the OHS Regulations will be achieved using a variety of existing approaches along a compliance continuum. This may include educating and counselling employers on their obligations, seeking an assurance of voluntary compliance from the employer, or issuing a compliance order to cease the contravention and take steps to prevent its reoccurrence. To address more serious or repeated offences and violations, an administrative monetary penalty under the new Part IV of the Code may be issued.

Contact

Kathaleen Nicholson
Acting Manager
Occupational Health and Safety Policy Unit
Workplace Directorate, Labour Program
Employment and Social Development Canada
165 De l’Hôtel-de-Ville Street
Place du Portage, Phase II, 10th Floor
Gatineau, Quebec
K1A 0J2
Telephone: 343‑572‑6395
Email: kathaleen.nicholson@labour-travail.gc.ca