Order 2019-66-06-01 Amending the Domestic Substances List: SOR/2019-160

Canada Gazette, Part II, Volume 153, Number 12

Registration

SOR/2019-160 May 29, 2019

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 footnote a, the Minister of the Environment is required to maintain the Domestic Substances List footnote b;

Therefore, the Minister of the Environment, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2019-66-06-01 Amending the Domestic Substances List.

Gatineau, May 22, 2019

Catherine McKenna
Minister of the Environment

Order 2019-66-06-01 Amending the Domestic Substances List

Amendments

1 Part 1 of the Domestic Substances List footnote 1 is amended by adding the following in numerical order:

58976-65-1 N

2 Part 3 of the List is amended by deleting the following:

18079-7 N

Amino acid, N,N-bis(carboxymethyl)-

Acide N,N-bis(carboxyméthyl)-aminé

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 Departments of Environment Canada and Health Canada (the Government) assessed information on eight substances (seven chemicals and polymers and one organism) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government is adding eight substances to the DSL. The Government also proposed that the identifier of one substance currently on the confidential portion of the DSL be updated. Industry indicated that the identity of this substance is no longer considered confidential business information. The substance is therefore being removed from the confidential portion of the DSL and added to the public portion.

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, as 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 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 established in 2001 and revised in 2012. For more details, please refer to the Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), which establishes 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 includes eight parts defined as follows:

Part 1

Sets out chemicals and polymers, except those referred to in Parts 2, 3, or 4, that are identified by their Chemical Abstract 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 Parts 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.

Addition of substances to the DSL

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

Criteria for the 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.

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 subsections 87(1), 87(5) or 112(1) of CEPA within 120 days after all of the following criteria have been met:

Adding the eight substances to the DSL

The Government assessed information on eight new substances (seven chemicals and polymers and one organism) and determined that they meet the criteria for addition to the DSL, under subsections 87(1), 87(5) and 112(1) of CEPA. These eight 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.

In addition, one substance identifier currently on the confidential portion DSL is updated under subsection 66(1) of CEPA. This substance is therefore being removed from the confidential portion of the DSL and added to the public portion of the DSL.

Objective

Order 2019-87-06-01 adds seven substances to the DSL, Order 2019-112-06-01 adds one substance to the DSL and Order 2019-66-06-01 removes one substance identifier from the confidential portion of the DSL and adds it to the public portion of 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 the administrative burden, such as the notification and assessment requirements.

Description

Order 2019-87-06-01 is made pursuant to subsections 87(1) and 87(5) of CEPA to add seven substances (chemicals and polymers) to the DSL:

Order 2019-112-06-01 is made pursuant to subsection 112(1) of CEPA to add one substance (organism) to the DSL:

Order 2019-66-06-01 is made pursuant to subsection 66(1) of CEPA to update the identifier of one substance currently listed on 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

Given that the orders are not expected to have any particular impacts on indigenous groups, no modern treaty obligations and associated Indigenous engagement and consultation were identified.

Instrument choice

According to CEPA, the Minister is required to add the substance on the DSL within 120 days of when it is determined that a substance meets the criteria for its addition. It was also determined that the appropriate instrument to add a substance and to update the identifier for a substance was to amend the DSL.

Regulatory analysis

Impacts

The Government assessed information on eight 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 eight substances do not pose risks to the environment or human health. These substances meet the criteria for addition to the DSL and therefore are being added to the DSL. They are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA.

In addition, the Government updates the identifier of one substance on the DSL, since industry has indicated that the identity of this substance is no longer considered confidential business information. It is satisfied that this change will increase the transparency of the DSL.

Small business lens

An assessment under the small business lens concluded that these orders will have no 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 new administrative or compliance costs on businesses.

Regulatory cooperation and alignment

There are no international agreements or obligations directly associated with these orders. Nevertheless, when a country has expressed some concerns regarding a substance and has implemented management measure on a substance, this information is taken into consideration for alignment.

Strategic environmental assessment

In accordance with The Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment is not required since the addition 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 particular impact on a specific group, based on factors such as gender, sex, age, language, education, geography, culture, ethnicity, income, ability, sexual orientation or gender identity.

Implementation, compliance and 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 (individual or corporation) 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 substances to which it relates, 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.

The orders 2019-87-06-01, 2019-112-06-01 and 2019-66-06-01 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

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