Order 2019-112-07-01 Amending the Domestic Substances List: SOR/2019-209

Canada Gazette, Part II, Volume 153, Number 13

Registration

SOR/2019-209 June 14, 2019

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 in or imported into Canada 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 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 2019-112-07-01 Amending the Domestic Substances List..

Gatineau, June 11, 2019

Catherine McKenna
Minister of the Environment

Order 2019-112-07-01 Amending the Domestic Substances List

Amendments

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

2 Part 7 of the List is amended by adding the following in numerical order:

19349-7 N

Recombinant human autologous T lymphocyte expressing a chimeric antigen receptor for human B cell maturation antigen

Lymphocyte T autologue humain recombinant, exprimant un récepteur antigénique chimérique pour l’antigène de maturation des cellules B humaines

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 Department of the Environment and the Department of Health (the Departments) assessed information on nine substances (seven chemicals and polymers, and two organisms) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL), as set out in the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Minister of the Environment (the Minister) is adding these nine substances to the DSL.

Background

Assessment of substances new to Canada

Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 108 of the 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 the 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 DSL (SOR/94-311) provides an inventory of substances in the Canadian marketplace. It was originally published in the Canada Gazette, Part II, in May 1994. The current structure of the DSL was established in 2001 and amended in 2012. For more details, please refer to the Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214) (PDF) (B), which established the structure of the DSL and to the Order 2012-87-09-01 Amending the Domestic Substances List (SOR/2012-229), which amended the DSL. The DSL is amended, on average, 10 times per year to add, update or delete substances.

The DSL 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 Abstract Service Registry Number (CAS RN), footnote 2 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 Number (IUBMB) 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

Criteria for addition of substances to the DSL

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

Living organisms must be added to the DSL under section 105 of CEPA if, between January 1, 1984, and December 31, 1986, they were manufactured or imported into Canada by any person 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 DSL under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days after the following criteria have been met:

Adding nine substances to the DSL

The Departments assessed information on nine new substances (seven chemicals and polymers, and two organisms) and determined that they meet the criteria for addition to the DSL, under subsection 87(5) or 112(1) of CEPA. These nine substances are therefore being added to the DSL and are no longer subject to the New Substances Notification Regulations (Chemicals and Polymers), nor to the New Substances Notification Regulations (Organisms).

Objective

Order 2019-87-07-01 Amending the Domestic Substances List (Order 2019-87-07-01) is made pursuant to subsection 87(5) of CEPA to add seven substances to the DSL, and Order 2019-112-07-01 Amending the Domestic Substances List (Order 2019-112-07-01) is made pursuant to subsection 112(1) of CEPA to add two substances to the DSL. These orders are expected to facilitate access to these substances for businesses as the substances are no longer subject to requirements under the New Substances Notification Regulations (Chemicals and Polymers), nor under the New Substances Notification Regulations (Organisms).

Description

The orders are legal instruments made by the Minister. The Order 2019-87-07-01 is made pursuant to subsection 87(5) of CEPA to add seven substances (chemicals and polymers) to the DSL:

The Order 2019-112-07-01 is made pursuant to subsection 112(1) of CEPA to add two substances (organisms) to the DSL:

Regulatory development

Consultation

As CEPA does not prescribe any public comment period before adding a substance to the DSL, no consultation period for these orders was deemed necessary.

Modern treaty obligations and Indigenous engagement and consultation

The orders are not expected to have any impact on Indigenous groups. Therefore, no modern treaty obligations and associated Indigenous engagement and consultations were identified.

Instrument choice

Under CEPA, the Minister is required to add substances to the DSL when they are determined to meet the criteria for addition. An order amending the DSL to add substances to the DSL is the only regulatory instrument available to comply with this obligation.

Regulatory analysis

Costs and benefits

The orders do not have any impact (costs or benefits) as they are administrative in nature, and are a federal obligation under subsection 87(5) or 112(1) of CEPA that is triggered once a substance meets the criteria for addition to the DSL.

Small business lens

An assessment under the small business lens concluded that these orders do not have any impact on small businesses.

“One-for-One” Rule

The “One-for-One” Rule does not apply to these orders, as they do not impose any administrative or compliance costs on businesses.

Regulatory cooperation and alignment

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

Strategic environmental assessment

In accordance with The Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan on additions to the DSL concluded that a strategic environmental assessment is not required for the orders, since the addition of substances to the DSL is administrative in nature and is an obligation under CEPA.

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.

Implementation, compliance and enforcement, and service standards

Implementation

Order 2019-87-07-01 and Order 2019-112-07-01 are now in force. Developing an implementation plan, a compliance strategy is not required when adding substances to the DSL. 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 activities involving them.

Compliance and enforcement

Where a person has questions concerning their obligations to comply with the orders, believes that they may be out of compliance or would like to request a pre-notification consultation, this person is 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. 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. Suspected violations can be reported to the Enforcement Branch by email at ec.enviroinfo.ec@canada.ca.

Contact

Nicole Davidson
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