Order 2022-105-01-01 Amending the Domestic Substances List: SOR/2022-234

Canada Gazette, Part II, Volume 156, Number 24

Registration
SOR/2022-234 November 7, 2022

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the Minister of the Environment has learned that the requirements set out in subsection 105(1) of the Canadian Environmental Protection Act, 1999 footnote a were not met in respect of the living organism referred to in the annexed Order;

Therefore, the Minister of the Environment makes the annexed Order 2022-105-01-01 Amending the Domestic Substances List under subsection 105(2) of the Canadian Environmental Protection Act, 1999 footnote a.

Gatineau, November 3, 2022

Steven Guilbeault
Minister of the Environment

Order 2022-105-01-01 Amending the Domestic Substances List

Amendment

1 Part 7 of the Domestic Substances List footnote 1 is amended by deleting the following:
13637-2
  • Name: Complex microbial culture
  • Source: Coastal marine waters of the Gulf of Mexico
  • History: Grown in a specialized medium
  • Characteristics: Spiral and rod-shaped microorganisms that are, in the fresh product, found in a proportion of 1:10
  • Use: Bioremediation of oil field production systems, waste streams, grease traps and various hazardous waste sites in Canada

Coming into Force

2 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 20 substances (14 chemicals and polymers and 6 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 20 substances to the Domestic Substances List. In addition, the Minister learned that a living organism that is already on the Domestic Substances List does not meet the criteria for addition to the Domestic Substances List as set out in CEPA. Therefore, under the authority of subsection 105(2) of CEPA, the Minister is deleting this living organism from the Domestic Substances List.

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 Notification and Testing of New 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. The current structure of the Domestic Substances List was established in 2001 (Order 2001-87-04-01 Amending the Domestic Substances List (PDF) [SOR/2001-214]), and amended in 2012 (Order 2012-87-09-01 Amending the Domestic Substances List [SOR/2012-229]). 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 defined as follows:

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)footnote 2 Registry Numbers 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 Significant New Activity (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 names 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 kg 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:

Adding 20 substances to the Domestic Substances List

The ministers assessed information on 20 substances (14 chemicals and polymers and 6 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 20 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).

Deleting one living organism from the Domestic Substances List

When a living organism is added to the Domestic Substances List pursuant to subsection 105(1) of CEPA and the Minister subsequently learns that the living organism did not meet the criteria for addition, the living organism must be deleted from the List under subsection 105(2) of CEPA.

The Minister has learned that one living organism added to the Domestic Substances List pursuant to subsection 105(1) of CEPA did not meet the criteria set out in subsection 105(1). On January 8, 2022, a notice entitled Notice of intent to amend the Domestic Substances List, deleting one non-eligible living organism was published in the Canada Gazette, Part I, for a 60-day public comment period. No information on the living organism was received during this period. Therefore, pursuant to subsection 105(2) of CEPA, this living organism is deleted from the Domestic Substances List.

Objective

The objective of Order 2022-87-10-01 Amending the Domestic Substances List is to add 14 substances to the Domestic Substances List.

The objective of Order 2022-105-01-01 Amending the Domestic Substances List is to delete one living organism from the Domestic Substances List.

The objective of Order 2022-112-10-01 Amending the Domestic Substances List is to add six living organisms to the Domestic Substances List.

Order 2022-87-10-01 and Order 2022-112-10-01 are expected to facilitate access to 20 substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of CEPA.

Description

Order 2022-87-10-01 is made under subsections 87(1) and 87(5) of CEPA to add 14 substances (chemicals and polymers) to the Domestic Substances List:

Order 2022-105-01-01 is made pursuant to subsection 105(2) of CEPA to delete one living organism from Part 7 of the Domestic Substances List.

Order 2022-112-10-01 is made pursuant to subsection 112(1) of CEPA to add six living organisms to the Domestic Substances List:

Regulatory development

Consultation

On January 8, 2022, a notice entitled Notice of intent to amend the Domestic Substances List, deleting one non-eligible living organism was published in the Canada Gazette, Part I, for a 60-day public comment period. No information on the living organism was received during this period. Therefore, Order 2022-105-01-01 is deleting one living organism as described in the notice.

As CEPA does not prescribe any public comment period before adding a substance to the Domestic Substances List, no consultation period for Order 2022-87-10-01 and Order 2022-112-10-01 was deemed necessary.

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. The Minister is also required to delete a substance from the List when he subsequently learns that the criteria for addition were not met. 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 20 substances to the Domestic Substances List is administrative in nature. Order 2022-87-10-01 and Order 2022-112-10-01 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.

On January 8, 2022, a notice entitled Notice of intent to amend the Domestic Substances List, deleting one non-eligible living organism was published in the Canada Gazette, Part I, for a 60-day public comment period. No information on the living organism was received during this period, and thus, the living organism is not expected to be currently imported or manufactured in Canada. Therefore, deleting this living organism from the Domestic Substances List is not expected to result in any incremental compliance costs for stakeholders. Deleting a living organism from the Domestic Substances List is a federal obligation under subsection 105(2) of CEPA that is triggered once it is learned that the criteria for addition under subsection 105(1) were not met.

Small business lens

The assessment of the small business lens concluded that Order 2022-87-10-01, Order 2022-105-01-01 and Order 2022-112-10-01 (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.

Contact

Thomas Kruidenier
Acting Executive Director
Program Development and Engagement 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