Order 2019-112-03-01 Amending the Domestic Substances List: SOR/2019-48

Canada Gazette, Part II, Volume 153, Number 5

Registration

SOR/2019-48 February 22, 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 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 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 2019-112-03-01 Amending the Domestic Substances List.

Gatineau, February 19, 2019

Catherine McKenna
Minister of the Environment

Order 2019-112-03-01 Amending the Domestic Substances List

Amendment

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

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

Environment and Climate Change Canada and Health Canada (the Government) assessed information on 10 substances (8 chemicals and polymers, and 2 organisms) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government is adding 10 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 Canadian Environmental Protection Act, 1999 (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 the 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 and was originally published in the Canada Gazette, Part II, in May 1994. The current structure of the DSL was initially established in June 2001 and revised in November 2012. For more details, please refer to Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), which establishes the structure of the DSL, published in the Canada Gazette, Part II, in July 2001, and to Order 2012-87-09-01 Amending the Domestic Substances List (SOR/2012-229), which amended the DSL, published in the Canada Gazette, Part II, in November 2012. 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 Abstracts Service Registry Number (CAS RN), 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; and

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

The DSL is amended, on average, 10 times per year to add, update or delete substances. 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.

A living organism must be added to the DSL under section 105 of CEPA if, between January 1, 1984, and December 31, 1986, it was manufactured or imported into Canada by any person (individual or corporation) and if during this period it entered or was released into the environment without being subject to conditions under an Act of Parliament or of 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 all of the following criteria have been met:

Adding the 10 substances to the DSL

The Government assessed information on 10 new substances (8 chemicals and polymers, and 2 organisms) and determined that they meet the criteria for their addition to the DSL, under subsections 87(1), 87(5) and 112(1) of CEPA. These 10 substances are therefore being added to the DSL and are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA.

Objectives

Order 2019-87-03-01 Amending the Domestic Substances List (Order 2019-87-03-01) adds eight substances to the DSL and Order 2019-112-03-01 Amending the Domestic Substances List (Order 2019-112-03-01) adds two substances to the DSL. These amendments to the DSL are expected to facilitate access to the substances that are added to the DSL for businesses by reducing costs and administrative burdens, such as notifications and assessment requirements.

Description

Order 2019-87-03-01 is made pursuant to subsections 87(1) and 87(5) of CEPA to add eight substances (chemicals and polymers) to the DSL.

Order 2019-112-03-01 is made pursuant to subsection 112(1) of CEPA to add two substances (organisms) to the DSL.

Consultation

As CEPA does not prescribe any public comment period before adding a substance to the DSL, no consultation period for Order 2019-87-03-01 and Order 2019-112-03-01 was deemed necessary.

Rationale

The Government assessed information on 10 new substances to Canada that were subject to notification and assessment requirements, as 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). The assessment determined that the 10 substances do not pose risks to the environment or human health. These substances meet the criteria for addition to the DSL and, therefore, are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA.

“One-for-One” Rule and small business lens

Since Order 2019-87-03-01 and Order 2019-112-03-01 decrease administrative burden, by removing notification and information requirements on the 10 substances, the “One-for-One” Rule and small business lens do not apply to these orders, as they do not impose any new administrative or compliance cost on small businesses.

Implementation, enforcement and service standards

Developing an implementation plan, a compliance strategy, or establishing a service standard is not required when adding substances to the DSL.

Where a person has questions concerning their obligations to comply with these orders, believes that they may be out of compliance, or would like to request a pre- notification consultation, this person is encouraged to discuss their particular circumstances with the program by contacting 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).

These orders do not constitute an endorsement from the Government of the 10 substances to which they relate, or 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.

Order 2019-87-03-01 and Order 2019-112-03-01 are now in force. CEPA 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, as well as the potential harm, intent, and history of compliance.

Contact

Julie Thompson
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