Order 2024-112-05-01 Amending the Domestic Substances List: SOR/2024-159

Canada Gazette, Part II, Volume 158, Number 15

Registration
SOR/2024-159 June 28, 2024

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the Minister of the Environment has been provided with information under paragraph 112(1)(a) of the Canadian Environmental Protection Act, 1999 footnote a in respect of each living organism referred to in the annexed Order that is being added to the Domestic Substances List footnote b under subsection 112(1) of that Act;

Whereas the Minister of the Environment and the Minister of Health are satisfied that those living organisms have been manufactured or imported by the person who provided the information prescribed under the New Substances Notification Regulations (Organisms) footnote c;

Whereas the period for assessing the information under section 108 of that Act has expired;

And whereas no conditions specified under paragraph 109(1)(a) of that Act in respect of those living organisms are in effect;

Therefore, the Minister of the Environment makes the annexed Order 2024-112-05-01 Amending the Domestic Substances List under subsections 112(1) and (5)footnote d of the Canadian Environmental Protection Act, 1999 footnote a.

Ottawa, June 26, 2024

Steven Guilbeault
Minister of the Environment

Order 2024-112-05-01 Amending the Domestic Substances List

Amendments

1 Part 5 of the Domestic Substances List footnote b is amended by adding the following in alphabetical order under the heading “Organisms/Organismes”:

2 (1) Part 6 of the List is amended by deleting the living organism “Pseudomonas aeruginosa ATCC 31480 S′” in column 1 and the portion of column 2 opposite the reference to that living organism.

(2) Part 6 of the List is amended by deleting the living organism “Pseudomonas aeruginosa ATCC 700370 S′” in column 1 and the portion of column 2 opposite the reference to that living organism.

(3) Part 6 of the List is amended by deleting the living organism “Pseudomonas aeruginosa ATCC 700371 S′” in column 1 and the portion of column 2 opposite the reference to that living organism.

Coming into Force

3 This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the orders.)

Issues

The Minister of the Environment and the Minister of Health (the ministers) assessed information on 13 substances (11 chemicals and polymers and 2 living organisms) and determined that they meet the criteria for addition to the Domestic Substances List, as set out in the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, under the authority of sections 87 and 112 of CEPA, the Minister of the Environment (the Minister) is adding these 13 substances to the Domestic Substances List.

Furthermore, it was determined that the potential risks to human health and the environment associated with significant new activities involving the living organisms Pseudomonas aeruginosa ATCC 31480, Pseudomonas aeruginosa ATCC 700370 and Pseudomonas aeruginosa ATCC 700371 are currently managed under the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations and therefore, the Minister is rescinding the Significant New Activity (SNAc) requirements concerning these living organisms.

Background

Assessment of substances new to Canada

Substances that are not on the Domestic Substances List are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 108 of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). CEPA and these regulations ensure that new substances introduced to the Canadian marketplace are assessed to identify potential risks to the environment and human health, and that appropriate control measures are taken, if deemed necessary.

For more information on the thresholds and scope of these regulations, please see section 1 in the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers) and section 2 of the Guidelines for the Notification and Testing of New Substances: Organisms.

Domestic Substances List

The Domestic Substances List (SOR/94-311) provides an inventory of substances in the Canadian marketplace. It was originally published in the Canada Gazette, Part II, in 1994, and its current structure was established in 2001 (Order 2001-87-04-01 Amending the Domestic Substances List (PDF) [SOR/2001-214]). The Domestic Substances List is amended, on average, 14 times per year to add, update or delete substances.

The Domestic Substances List includes eight parts:

Part 1
Sets out chemicals and polymers, except those referred to in Part 2, 3 or 4, that are identified by their Chemical Abstracts Service (CAS) Registry Numbersfootnote 1 or their Substance Identity Numbers assigned by the Department of the Environment and the names of the substances.
Part 2
Sets out chemicals and polymers subject to SNAc requirements that are identified by their CAS Registry Numbers.
Part 3
Sets out chemicals and polymers, except those referred to in Part 4, that are identified by their masked namesfootnote 2 and their Confidential Substance Identity Numbers (also referred to as Confidential Accession Numbers [CANs]) assigned by the Department of the Environment.
Part 4
Sets out chemicals and polymers subject to SNAc requirements that are identified by their masked names and their CANs.
Part 5
Sets out inanimate biotechnology products and living organisms, except those referred to in Part 6, 7 or 8, that are identified by their American Type Culture Collection (ATCC) numbers, International Union of Biochemistry and Molecular Biology (IUBMB) numbers or specific substance names.
Part 6
Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their ATCC numbers, IUBMB numbers or specific substance names.
Part 7
Sets out inanimate biotechnology products and living organisms, except those referred to in Part 8, that are identified by their masked names and their CANs.
Part 8
Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their masked names and their CANs.

Adding substances to the Domestic Substances List

Chemicals or polymers must be added to the Domestic Substances List under section 66 of CEPA if they were manufactured in, or imported into, Canada by any person (individual or corporation) between January 1, 1984, and December 31, 1986, in a quantity greater than or equal to 100 kilograms in any one calendar year or if during this period, they were in Canadian commerce or used for commercial manufacturing purposes in Canada.

Living organisms must be added to the Domestic Substances List under section 105 of CEPA if they were manufactured in, or imported into, Canada by any person between January 1, 1984, and December 31, 1986, and if, during this period, they entered or were released into the environment without being subject to conditions under an Act of Parliament or the legislature of a province.

In addition, new substances must be added to the Domestic Substances List under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days after the following criteria have been met:

Criteria for adding, varying or rescinding SNAc requirements for substances on the Domestic Substances List

Amendments to the Domestic Substances List may also add, vary or rescind reporting obligations imposed under the SNAc provisions of CEPA. If the ministers assess a substance and available information suggests that certain new activities related to that substance may pose a risk to human health or the environment, the Minister may add that substance to the Domestic Substances List with reporting obligations under the SNAc provisions of CEPA [subsection 87(3) or 112(3)]. The SNAc provisions of CEPA establish a requirement for any person considering undertaking a significant new activity in relation to the substance to submit a Significant New Activity Notification (SNAN) to the Minister containing certain required information. Upon receipt of the complete information, the ministers would conduct further assessment of the substance, and, if necessary, implement risk management measures before the activity is undertaken. To see the substances subject to SNAc provisions of CEPA, please visit the Government of Canada’s Open Data Portal.

Adding 13 substances to the Domestic Substances List

The ministers assessed information on 13 substances (11 chemicals and polymers and 2 living organisms) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List, under subsection 87(1), 87(5) or 112(1) of CEPA. These 13 substances are therefore being added to the Domestic Substances List and, as a result, are no longer subject to the New Substances Notification Regulations (Chemicals and Polymers) nor to the New Substances Notification Regulations (Organisms).

Rescinding SNAc requirements for three living organisms

In January 2015, a public commitment was made by the Department of the Environment and the Department of Health to review all SNAc requirements that were adopted between 2001 and 2014. The purpose of the review is to ensure that SNAc requirements are consistent with current information, policies and approaches. Resulting changes to SNAc requirements are expected to provide greater clarity of scope and improved ease of compliance, while protecting Canadians and their environment.

As part of this review, it was determined that the potential risks to human health and the environment associated with significant new activities involving the living organisms Pseudomonas aeruginosa ATCC 31480, Pseudomonas aeruginosa ATCC 700370 and Pseudomonas aeruginosa ATCC 700371, are currently managed under the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations.

As a result, the SNAc requirements for these living organisms are no longer warranted and are thus removed from the Domestic Substances List.

Objective

The objective of Order 2024-87-05-01 Amending the Domestic Substances List (Order 2024-87-05-01) is to add 11 substances to the Domestic Substances List.

The objective of Order 2024-112-05-01 Amending the Domestic Substances List (Order 2024-112-05-01) is to add two living organisms to the Domestic Substances List. Another objective of Order 2024-112-05-01 is to rescind the SNAc requirements concerning three living organisms identified as Pseudomonas aeruginosa ATCC 31480, Pseudomonas aeruginosa ATCC 700370 and Pseudomonas aeruginosa ATCC 700371 as these requirements are no longer warranted.

Order 2024-87-05-01 is expected to facilitate access to the 11 substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) of CEPA.

Description

Order 2024-87-05-01 is made under subsections 87(1) and 87(5) of CEPA to add 11 chemicals and polymers to the Domestic Substances List:

Order 2024-112-05-01 is made pursuant to subsections 112(1) and 112(5) of CEPA to add two living organisms to the Domestic Substances List and to rescind SNAc requirements for three living organisms:

Regulatory development

Consultation

As CEPA does not prescribe any public comment period before adding a substance to the Domestic Substances List, no consultation period for Order 2024-87-05-01 was deemed necessary.

On June 19, 2021, the Minister published a Notice of intent to amend the Domestic Substances List under subsection 112(3) of the Canadian Environmental Protection Act, 1999 with the proposed rescission of the SNAc requirements for Pseudomonas aeruginosa ATCC 31480, Pseudomonas aeruginosa ATCC 700370 and Pseudomonas aeruginosa ATCC 700371. The notice of intent was published in the Canada Gazette, Part I, for a 60-day comment period. The Minister received no comments.

Modern treaty obligations and Indigenous engagement and consultation

The assessment of modern treaty implications made in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders amending the Domestic Substances List do not introduce any new regulatory requirements and, therefore, do not result in any impact on modern treaty rights or obligations.

Instrument choice

Under CEPA, the Minister is required to add a substance to the Domestic Substances List when it is determined to meet the criteria for addition. Orders amending the Domestic Substances List are the only regulatory instruments that allow the Minister to comply with these obligations.

Regulatory analysis

Benefits and costs

Adding 13 substances to the Domestic Substances List and rescinding SNAc requirements is administrative in nature. Order 2024-87-05-01 and Order 2024-112-05-01 (the orders) do not impose any regulatory requirements on businesses and, therefore, do not result in any incremental compliance costs for stakeholders or enforcement costs for the Government of Canada. Adding substances to the Domestic Substances List is a federal obligation under section 87 or 112 of CEPA that is triggered once a substance meets the criteria for addition.

Small business lens

The assessment of the small business lens concluded that the orders have no impact on small businesses, as they do not impose any administrative or compliance costs on businesses.

One-for-one rule

The assessment of the one-for-one rule concluded that the rule does not apply to the orders, as there is no impact on industry.

Regulatory cooperation and alignment

There are no international agreements or obligations directly associated with the orders.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan of additions to the Domestic Substances List concluded that a strategic environmental assessment is not required for the orders.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for the orders.

Implementation, compliance and enforcement, and service standards

Implementation

The orders are now in force. Developing an implementation plan is not required when adding substances to the Domestic Substances List. The orders do not constitute an endorsement from the Government of Canada of the substances to which they relate, nor an exemption from any other laws or regulations that are in force in Canada and that may apply to these substances or to activities involving them.

Compliance and enforcement

Where a person has questions concerning their obligation to comply with an order, believes that they may be out of compliance, or would like to request a pre-notification consultation, they are encouraged to contact the Substances Management Information Line at substances@ec.gc.ca (email), 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada).

The orders are made under the authority of CEPA, which is enforced in accordance with the Canadian Environmental Protection Act: compliance and enforcement policy. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations, and consistency in enforcement when deciding which enforcement measures to take. Suspected violations can be reported to the Enforcement Branch of the Department of the Environment by email at enviroinfo@ec.gc.ca.

Contacts

Korian Soumano
Acting Director
Regulatory Operations, Policy and Emerging Sciences Division
Department of the Environment
Gatineau, Quebec
K1A 0H3

Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Fax: 819‑938‑5212
Email: substances@ec.gc.ca