Order 2020-112-13-01 Amending the Domestic Substances List: SOR/2020-176

Canada Gazette, Part II, Volume 154, Number 18

Registration

SOR/2020-176 August 21, 2020

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 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 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 2020-112-13-01 Amending the Domestic Substances List.

Gatineau, August 20, 2020

Jonathan Wilkinson
Minister of the Environment

Order 2020-112-13-01 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 Order.)

Issues

The Minister of the Environment and the Minister of Health (the ministers) assessed information on one substance (living organism) new to Canada and determined that it meets 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 section 112 of CEPA, the Minister of the Environment (the Minister) is adding this living organism to the Domestic Substances List.

Background

Assessment of living organisms new to Canada

Living organisms 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 106 and 108 of CEPA, as well as in the New Substances Notification Regulations (Organisms). CEPA and these Regulations ensure that new living organisms 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 scope of these Regulations, please see 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 (B) [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, 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 (CAS) registry number, 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 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 living organisms to the Domestic Substances List

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, living organisms must be added to the Domestic Substances List under subsection 112(1) of CEPA within 120 days after the following criteria have been met:

Adding one living organism to the Domestic Substances List

The ministers assessed information on one living organism new to Canada and determined that it meets the criteria for addition to the Domestic Substances List, under subsection 112(1) of CEPA. This living organism is therefore being added to the Domestic Substances List and, as a result, is no longer subject to the New Substances Notification Regulations (Organisms).

Objective

The objective of Order 2020-112-13-01 Amending the Domestic Substances List (the Order) is to add one living organism to the Domestic Substances List.

The Order is expected to facilitate access to one living organism for businesses, as this living organism is no longer subject to requirements under subsection 106(1) of CEPA.

Description

The Order 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:

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 Order 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 an order amending the Domestic Substances List does not impose any regulatory or administrative burdens and therefore does not result in any impact on modern treaty rights or obligations. The assessment also concluded that the making of an order under section 112 of CEPA does not require specific engagement and consultation with Indigenous peoples.

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 one living organism to the Domestic Substances List does not have any impact (benefits or costs), as it is administrative in nature and is a federal obligation under section 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 Order has no associated impact on small businesses, as it does not impose any administrative or compliance costs on businesses.

One-for-one rule

The one-for-one rule does not apply to the Order, 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 Order.

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 Order.

Gender-based analysis plus (GBA+)

The Order is 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 and compliance and enforcement

Implementation

The Order is now in force. Developing an implementation plan is not required when adding substances to the Domestic Substances List. The Order does not constitute an endorsement from the Government of Canada of the substance to which it relates, nor an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or to activities involving it.

Compliance

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).

Enforcement

The Order is 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

Andrea Raper
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