Order 2021-112-03-01 Amending the Domestic Substances List: SOR/2021-16

Canada Gazette, Part II, Volume 155, Number 5

Registration
SOR/2021-16 February 15, 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 organism referred to in the annexed Order;

Whereas, in respect of the living organism 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 organism has been manufactured in 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 organism 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 2021-112-03-01 Amending the Domestic Substances List.

Gatineau, February 12, 2021

Jonathan Wilkinson
Minister of the Environment

Order 2021-112-03-01 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 oncolytic Vaccinia virus Copenhagen strain with deletions in the 5 prime and 3 prime regions of the genome and B8R locus disruption, expressing anti-CTLA-4 antibody, FLT-3 ligand and membrane bound IL-12 (p35 subunit) (TBio-6517) 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 18 substances (17 chemicals and polymers, and one living organism) 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 18 substances to the Domestic Substances List. Under the authority of section 66 of CEPA, the minister is also deleting one invalid Chemical Abstracts Service (CAS) registry number footnote 1 from the list and updating the identifier or masked name of nine substances already on 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 over certain quantities 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]). 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 CAS registry number, 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 registry number.
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:

Adding 18 substances to the Domestic Substances List

The ministers assessed information on 18 substances (17 chemicals and polymers, and one living organism) 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 18 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 invalid CAS registry number from the Domestic Substances List

One CAS registry number on the Domestic Substances List is invalid and therefore, under the authority of section 66 of CEPA, the minister is deleting this registry number from the Domestic Substances List.

Updating the identifier of nine substances on the Domestic Substances List

Industry indicated that the identities of four substances are no longer considered confidential business information. In addition, industry has requested that the masked name of four other substances be updated. Finally, a polymer with reduced regulatory requirements as specified in section 9 of the New Substances Notification Regulations (Chemicals and Polymers) was added to the Domestic Substances List without the letter “P” after the substance identifier. Therefore, under the authority of section 66 of CEPA, the minister is moving four substances from a confidential part to a public part of the Domestic Substances List, updating the masked name of four other substances and updating the identifier of one substance on the list, adding a “P” flag.

Objective

The objective of Order 2021-87-03-01 Amending the Domestic Substances List (Order 2021-87-03-01) is to add 17 substances to the Domestic Substances List.

The objective of Order 2021-112-03-01 Amending the Domestic Substances List (Order 2021-112-03-01) is to add one substance to the Domestic Substances List.

The objectives of Order 2021-66-03-01 Amending the Domestic Substances List (Order 2021-66-03-01) are

Orders 2021-87-03-01, 2021-112-03-01 and 2021-66-03-01 (the orders) are expected to facilitate access to 18 substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of CEPA, and to increase transparency regarding 9 substances currently on the Domestic Substances List.

Description

The Order 2021-87-03-01 is a legal instrument made by the Minister pursuant to subsections 87(1) and 87(5) of CEPA to add 17 substances (chemicals and polymers) to the Domestic Substances List:

The Order 2021-112-03-01 is a legal instrument made by the Minister pursuant to subsection 112(1) of CEPA to add one living organism to the Domestic Substances List:

The Order 2021-66-03-01 is a legal instrument made by the Minister pursuant to subsection 66(1) of CEPA to delete one invalid registry number and update the identifier or the masked names of nine substances (chemicals and polymers) on 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. Orders amending the Domestic Substances List are the only regulatory instrument that allows the Minister to comply with this obligation.

Regulatory analysis

Benefits and costs

Adding 18 substances to the Domestic Substances List, updating 9 substances on the Domestic Substances List and deleting one invalid registry number do not have any impact (benefits or costs), as they are administrative in nature. 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 (GBA+)

The orders are not expected to have any impact on specific groups based on factors such as sex, gender identity, ethnicity, ability, age, religion, language, geography, culture, income, sexual orientation or education, as they do not introduce any new regulatory requirements.

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 Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999 (CEPA, 1999). 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:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Fax: 819‑938‑5212
Email: eccc.substances.eccc@canada.ca