Order 2021-112-06-01 Amending the Domestic Substances List: SOR/2021-98
Canada Gazette, Part II, Volume 155, Number 11
Registration
SOR/2021-98 May 7, 2021
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 the living organisms referred to in the annexed Order;
Whereas, in respect of the living organisms being added to the Domestic Substances List footnote b pursuant to subsection 112(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that the living organisms have been manufactured or imported by the person who provided the information prescribed by 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 under paragraph 109(1)(a) of that Act in respect of the living organisms are in effect;
Therefore, the Minister of the Environment, pursuant to subsection 112(1) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2021-112-06-01 Amending the Domestic Substances List.
Gatineau, May 6, 2021
Jonathan Wilkinson
Minister of the Environment
Order 2021-112-06-01 Amending the Domestic Substances List
Amendment
1 Part 5 of the Domestic Substances List footnote b is amended by adding the following in alphabetical order under the heading “Organisms/Organismes”:
- Human allogeneic CAR T cells targeting CD70 and genetically modified by CRISPR/Cas9 disrupting the T cell receptor alpha constant (TRAC), β2-microglobulin (B2M), and CD70 loci; and by a CAR gene-containing recombinant adeno-associated virus (AAV) vector inserting the anti-CD70 CAR expression cassette into the TRAC locus (CTX130) N
- Recombinant non-replicating human adenovirus type 26 encoding the severe acute respiratory syndrome coronavirus 2 Spike protein (Ad26.COV2.S) N
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 10 substances (8 chemicals and polymers, and 2 living organisms) new to Canada 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 10 substances to 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 Guidelines for the Notification and Testing of New Substances: 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, 2.1 MB] [SOR/2001-214]), and amended in 2012 ([ARCHIVED] Order 2012-87-09-01 Amending the Domestic Substances List [SOR/2012-229]). The Domestic Substances List is amended, on average, 12 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 Registry Number (CAS RN) footnote 1, or their Substance Identity Number assigned by the Department of the Environment and the name of the substance.
- Part 2 Sets out chemicals and polymers subject to significant new activity (SNAc) requirements that are identified by their CAS RN.
- Part 3 Sets out chemicals and polymers, except those referred to in Part 4, that are identified by their masked name and their Confidential Accession Number (CAN) assigned by the Department of the Environment.
- Part 4 Sets out chemicals and polymers subject to SNAc requirements that are identified by their masked name and their CAN.
- 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) number, International Union of Biochemistry and Molecular Biology (IUBMB) number or specific substance name.
- Part 6 Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their ATCC number, IUBMB number or specific substance name.
- Part 7 Sets out inanimate biotechnology products and living organisms, except those referred to in Part 8, that are identified by their masked name and their CAN.
- Part 8 Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their masked name and their CAN.
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:
- The Minister has been provided with the regulatory information regarding the substance. The information to be provided is set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms);
- The ministers are satisfied that the substance has already been manufactured in, or imported into, Canada in the prescribed quantity or conditions by the person who provided the information;
- The period prescribed under section 83 or 108 of CEPA for the assessment of the information submitted for the substance has expired; and
- The substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) or 109(1)(a) of CEPA on its import or manufacture.
Adding 10 substances to the Domestic Substances List
The ministers assessed information on 10 substances (8 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(5) or 112(1) of CEPA. These 10 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), or to the New Substances Notification Regulations (Organisms).
Objective
The objective of Order 2021-87-06-01 Amending the Domestic Substances List (Order 2021-87-06-01) is to add eight substances to the Domestic Substances List.
The objective of Order 2021-112-06-01 Amending the Domestic Substances List (Order 2021-112-06-01) is to add two substances to the Domestic Substances List.
Order 2021-87-06-01 and Order 2021-112-06-01 (the orders) are expected to facilitate access to 10 substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of CEPA.
Description
Order 2021-87-06-01 is made pursuant to subsection 87(5) of CEPA to add eight substances (chemicals and polymers) to the Domestic Substances List:
- four substances identified by their CAS RN are added to Part 1 of the Domestic Substances List; and
- four substances identified by their masked name and their CAN are added to Part 3 of the Domestic Substances List. Masked names are regulated under the Masked Name Regulations and are created to protect confidential business information.
Order 2021-112-06-01 is made pursuant to subsection 112(1) of CEPA to add two living organisms to the Domestic Substances List:
- two substances identified by their specific substance name are added to Part 5 of the Domestic Substances List.
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 the orders 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. An order amending the Domestic Substances List is the only regulatory instrument that allows the Minister to comply with this obligation.
Regulatory analysis
Benefits and costs
Adding 10 substances to the Domestic Substances List is administrative in nature. 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 small business lens analysis concluded that the orders have no associated impact on small businesses, as they do not impose any administrative or compliance costs on businesses.
One-for-one rule
The one-for-one rule does not apply to the orders, as there are no incremental changes in administrative burden imposed 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 and compliance and enforcement
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 eccc.substances.eccc@canada.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 ec.enviroinfo.ec@canada.ca.
Contact
Thomas Kruidenier
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
Telephone: 1‑800‑567‑1999 (toll-free in Canada)
or 819‑938‑3232 (outside of Canada)
Fax: 819‑938‑5212
Email: eccc.substances.eccc@canada.ca