Order 2020-112-12-01 Amending the Domestic Substances List: SOR/2020-204

Canada Gazette, Part II, Volume 154, Number 20

Registration
SOR/2020-204 September 18, 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 in or imported into Canada 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 2020-112-12-01 Amending the Domestic Substances List.

Gatineau, September 17, 2020

Jonathan Wilkinson
Minister of the Environment

Order 2020-112-12-01 Amending the Domestic Substances List

Amendment

1 Part 7 of the Domestic Substances List footnote b is amended by adding the following in numerical order:

19477-5 N Human T lymphocytes transduced with a self-inactivating lentiviral vector, encoding an affinity optimized T cell receptor targeting the NY-ES0-1/LAGE-1a antigen

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 10 substances (nine 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 10 substances to the Domestic Substances List.

The ministers identified potential human health concerns if one of the 10 substances, siloxanes and silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propyl] group-terminated, polymers with Bu methacrylate, 2-ethylhexyl acrylate and Me methacrylate (Chemical Abstracts Service Registry Number [CAS Registry Number] footnote 1 756819-45-1), were to be used in certain new activities. In order to continue addressing these potential human health concerns, the Minister is maintaining the existing requirements under the significant new activity (SNAc) provisions of CEPA applied to this substance.

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 (B) [PDF, 2.1 MB] [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 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 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:

Criteria for adding, varying or rescinding SNAc requirements for substances on the Domestic Substances List

Amendments to the Domestic Substances List may also allow the addition, the variation or the rescission of reporting obligations imposed under the SNAc provisions of CEPA, the application guidelines of which are defined in the Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999. If the ministers assess a substance and available information suggests that certain new activities related to that substance may pose a risk to human health or the environment, the Minister may add that substance to the Domestic Substances List with reporting obligations under the SNAc provisions of CEPA (subsection 87(3) or 112(3)). The SNAc provisions of CEPA establish a requirement for any person considering undertaking a significant new activity in relation to the substance to submit a Significant New Activity notification (SNAN) to the Minister containing certain required information. Upon receipt of the complete information, the ministers would conduct further assessment of the substance, and, if necessary, implement risk management measures before the activity is undertaken. To see the substances subject to SNAc provisions of CEPA, please consult the Significant New Activity Publications under the Canadian Environmental Protection Act, 1999 on the Government of Canada’s Open Data Portal.

Adding 10 substances to the Domestic Substances List

The ministers assessed information on 10 substances (nine 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(5) or 112(1) of CEPA. These 10 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).

In addition, the Minister is maintaining the SNAc provisions of CEPA that have been applied to one of the 10 substances, identified by CAS Registry Number 756819-45-1.

The SNAc provisions of CEPA were applied to this substance prior to its addition to the Domestic Substances List pursuant to the Significant New Activity Notice No. 19443, published in September 2018. The SNAc provisions of CEPA were applied to address potential human health concerns if the substance were to be used in certain new activities involving consumer products or cosmetics. Potential human health concerns were identified because the substance may cause pulmonary complications if inhaled.

Therefore, the SNAc requirements on the substance are being maintained and, as a result, they are being added with the substance to the Domestic Substances List.

Objective

The first objective of Order 2020-87-12-01 Amending the Domestic Substances List (Order 2020-87-12-01) is to add nine substances to the Domestic Substances List. The second objective of Order 2020-87-12-01 is to continue contributing to the protection of human health by maintaining the SNAc provisions of CEPA applied to the substance identified by CAS Registry Number 756819-45-1. Order 2020-87-12-01 maintains the requirement that the Minister be notified of any significant new activity involving the substance so that further assessment of the substance is conducted, and, if necessary, risk management measures are implemented before the activity is undertaken.

The objective of Order 2020-112-12-01 Amending the Domestic Substances List (Order 2020-112-12-01) is to add one substance to the Domestic Substances List.

Order 2020-87-12-01 and Order 2020-112-12-01 (the Orders) are expected to facilitate access to the 10 substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of CEPA.

Description

Order 2020-87-12-01 is a legal instrument made by the Minister pursuant to subsection 87(3) or (5) of CEPA to add nine substances (chemicals and polymers) to the Domestic Substances List:

The SNAc provisions of CEPA apply to the substance identified by CAS Registry Number 756819-45-1. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substance for a significant new activity as defined in the Order.

Order 2020-112-12-01 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:

SNAc applicability and reporting requirements

Under Order 2020-87-12-01, any person wishing to engage in a significant new activity in relation to the substance identified by CAS Registry Number 756819-45-1 is required to submit a SNAN to the Minister. The SNAN must contain all of the information prescribed in the Order, and must be submitted at least 90 days prior to the manufacture, import or use of the substance for the proposed significant new activity. The ministers will use the information submitted to conduct further assessment of the substance, and, if necessary, implement risk management measures before the activity is undertaken.

Activities subject to notification requirements

The notification requirements apply to the use of the substance identified by CAS Registry Number 756819-45-1 in the manufacture of any of the following products in which the substance is present in a concentration equal to orgreater than 0.1% by weight:

The notification requirements also apply to the use of the substance identified by CAS Registry Number 756819-45-1 in a quantity greater than 10 kg in a calendar year, in any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight:

Activities not subject to notification requirements

The notification requirements do not apply to uses of the substance identified by CAS Registry Number 756819-45-1 that are regulated under any Act of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act. The notification requirements also do not apply to any transient reaction intermediate, impurity, contaminant, partially unreacted material, or incidental reaction product and, under certain circumstances, to mixtures, manufactured items, wastes or substances carried through Canada. For more information on these terms, including definitions, please see section 3.2 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers. Please note that, according to section 3 and subsection 81(6) of CEPA, individual components of a mixture may be subject to the notification requirements under certain circumstances.

Activities involving the use of the substance identified by CAS Registry Number 756819-45-1 as a research and development substance, site-limited intermediate substances or in the manufacture of an export-only product are also excluded from notification requirements. For more information on these terms, including definitions, please see section 3.5 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Information requirements

The information required under Order 2020-87-12-01 relates to details surrounding uses of the substance, exposure information and toxicity to human health. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

The information required to complete a SNAN is unique to each substance and is described within the Order. For guidance on preparing a SNAN, please see section 1.3 and section 4 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

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.

Applying the SNAc provisions of CEPA on substances new to Canada is considered when there is suspicion that activities other than those notified may pose a risk to human health or the environment. For more information, please consult the Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999.

Regulatory analysis

Benefits and costs

Adding 10 substances 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 87 or 112 of CEPA that is triggered once a substance meets the criteria for addition.

Maintaining the SNAc provisions of CEPA on the substance identified by CAS Registry Number 756819-45-1 continues contributing to the protection of human health by requiring that potential significant new activities involving the substance undergo further assessment and that, if necessary, risk management measures are implemented before the activity is undertaken.

Order 2020-87-12-01 does not impose any regulatory requirements (and, therefore, any administrative of compliance costs) on businesses related to current activities. Order 2020-87-12-01 would continue to only target significant new activities involving the substance identified by CAS Registry Number 756819-45-1, should any person choose to pursue such an activity. In the event that any person wishes to use, import, or manufacture the substance for a significant new activity, they would be required to submit a SNAN to the Minister containing the complete information referred to in Order 2020-87-12-01.

While there is no notification fee associated with submitting a SNAN to the Minister in response to Order 2020-87-12-01, the notifier may assume costs associated with generating data and supplying the required information. Similarly, in the event that a SNAN is received, the Department of the Environment and the Department of Health would incur costs for processing the information and conducting further assessment of the substance to which the SNAN relates. The Department of the Environment will incur negligible costs for conducting compliance promotion and enforcement activities associated with the Orders.

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 related to current activities.

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 related to current activities.

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, compliance and enforcement, and service standards

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

When assessing whether or not a substance is subject to the SNAc provisions of CEPA, a person is expected to make use of information in their possession, or to which they may reasonably be expected to have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance are expected to have access to import records, usage information and the relevant safety data sheet (SDS).

Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products, and may not include all the information on these hazards. Therefore, an SDS may not list all product ingredients or substances that may be subject to the SNAc provisions of CEPA. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that a substance added to the Domestic Substances List through any order is toxic or capable of becoming toxic under section 64 of CEPA, the person who is in possession or has knowledge of the information and is involved in activities with the substance, is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. In cases where a person receives possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN. The Substances Management Advisory Note “Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999” provides more detail on this subject.

Any person who transfers the physical possession or control of a substance subject to an order to another should notify that person of their obligation to comply with that order, including the obligation to notify the Minister of any significant new activity and to provide all the required information specified in that order.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult during the planning or preparation of a SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

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 by email at eccc.substances.eccc@canada.ca, or by phone at 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada).

Enforcement

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.

Service standards

In the event that a SNAN is submitted to the Minister in relation to the substance identified by CAS Registry Number 756819-45-1, the ministers will assess the information after the complete information is received, within the prescribed timelines set out in Order 2020-87-12-01.

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