Order 2018-112-02-01 Amending the Domestic Substances List: SORS/2018-45

Canada Gazette, Part II: Volume 152, Number 7

Registration

March 19, 2018

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 d}, makes the annexed Order 2018-112-02-01 Amending the Domestic Substances List.

Gatineau, March 14, 2018

Catherine McKenna
Minister of the Environment

Order 2018-112-02-01 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”:

• cold-adapted, temperature-sensitive and attenuated influenza A/Bolivia/559/2013 (H1N1) virus N
• cold-adapted, temperature-sensitive and attenuated influenza A/California/7/2009 (H1N1) virus N
• cold-adapted, temperature-sensitive and attenuated influenza A/New Caledonia/71/2014 (H3N2) virus N
• cold-adapted, temperature-sensitive and attenuated influenza A/Perth/16/2009 (H3N2) virus N
• cold-adapted, temperature-sensitive and attenuated influenza A/Slovenia/2903/2015 (H1N1) virus N
• cold-adapted, temperature-sensitive and attenuated influenza A/Switzerland/9715293/2013 (H3N2) virus N
• cold-adapted, temperature-sensitive and attenuated influenza A/Texas/50/2012 (H3N2) virus N
• cold-adapted, temperature-sensitive and attenuated influenza A/Victoria/361/2011 (H3N2) virus N
• cold-adapted, temperature-sensitive and attenuated influenza B/Brisbane/60/2008 virus N
• cold-adapted, temperature-sensitive and attenuated influenza B/Massachusetts/2/2012 virus N
• cold-adapted, temperature-sensitive and attenuated influenza B/Phuket/3073/2013 virus N
• cold-adapted, temperature-sensitive and attenuated influenza B/Wisconsin/1/2010 virus N

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 Government of Canada (the Government) assessed information on 28 substances new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government added 28 substances to the DSL, 12 of which are added under the Order 2018-112-02-01 Amending the Domestic Substances List (Order 2018-112-02-01) and 16 substances under the Order 2018-87-02-01 Amending the Domestic Substances List (Order 2018-87-02-01).

The Government identified potential human health concerns if one of the 28 substances (Chemical Abstract Service Registry Number [CAS RN] 6712-98-7) is used in certain new activities. For this reason, reporting obligations under the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) were maintained as the substance is added to the DSL under Order 2018-87-02-01.

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 109 of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) ^{footnote 2} and the New Substances Notification Regulations (Organisms). ^{footnote 3} These regulations are administered by the New Substances Program and were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds^{footnote 4} are risk assessed to identify potential hazards to the environment and human health, and that appropriate control measures are taken, if deemed necessary.

Domestic Substances List

The DSL is an inventory of substances in the Canadian marketplace published in the Canada Gazette, Part II, in May 1994. ^{footnote 5}

The current structure of the DSL was established in July 2001 ^{footnote 6} and it includes 8 parts defined as follows:

• Part 1 ^{footnote 7} sets out chemicals and polymers, except those referred to in Part 2, 3 or 4, that are identified by their 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 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^{footnote 8} 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 CAS RN, 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 CAS RN, 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.

The DSL is amended on average 10 times a year to add or delete substances. A substance must be added to the DSL under section 66 of CEPA if it was manufactured or imported into Canada by any person in a quantity greater than 100 kg in any one calendar year, or if it was in Canadian commerce, or used for commercial manufacturing purposes in Canada between January 1, 1984, and December 31, 1986.

A living organism must be added to the DSL under section 105 of CEPA if it was manufactured or imported in Canada by any person between January 1, 1984, and December 31, 1986, 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 a province.

In addition, a substance must be added to the DSL under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days once all of the following criteria are met:

• the Minister of the Environment has been provided with information regarding the substance; ^{footnote 9}
• the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada in accordance with the conditions set out in subsection 87(1) or 112(1) of CEPA by the person who provided the information;
• the period prescribed for the assessment of the information submitted for the substance has expired; and
• the substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) or 109(1)(a) of CEPA on its import or manufacture.

Amendments to the DSL may also add, vary or rescind reporting obligations imposed under the SNAc provisions of CEPA.^{footnote 10} When substances are suspected of posing a risk to human health or the environment if used in certain new activities, they can be added to the DSL with reporting obligations under subsection 87(3) or 112(3) of CEPA. The information submitted enables the Government to assess risks associated with proposed new uses of substances before they are undertaken in Canada and determine whether additional risk management may be required.

Adding 28 substances to the DSL

The Government assessed information on 28 new substances (12 living organisms and 16 chemicals and polymers) reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL, under subsections 112(1) [12 substances] and 87(1) and 87(5) [16 substances] of CEPA. These 28 substances were therefore added to the DSL and are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA.

The Government identified potential human health concerns if one of the 28 substances (CAS RN 6712-98-7) is used in certain new activities. For this reason, the SNAc provisions under CEPA were applied to this substance in March 2017,^{footnote 11} before its addition to the DSL. In order to maintain the reporting obligations associated with the substance, SNAc requirements are carried over as the substance is added to the DSL under Order 2018-87-02-01.

Objectives

Order 2018-112-02-01 is made pursuant to subsection 112(1) of CEPA to add 12 substances (living organisms) to the DSL.

Order 2018-87-02-01 is made pursuant to subsections 87(1), (3) and (5) of CEPA to add 16 substances (chemicals and polymers) to the DSL and maintain the SNAc requirements associated with the substance CAS RN 6712-98-7.

By adding 28 substances to the DSL, these substances are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA. This is expected to facilitate access to these substances.

Description

The Order 2018-87-02-01 adds 16 substances (chemical and polymers) to the DSL. Five substances identified by their CAS RN are added to Part 1 of the DSL and 10 substances identified by their masked name and their CAN are added to Part 3 of the DSL.

The Order 2018-112-02-01 adds 12 substances (living organisms) identified by their substance name to Part 5 of the DSL.

Also, one substance identified by its CAS RN is added to Part 2 of the DSL. This substance (CAS RN 6712-98-7) is subject to the SNAc provisions under CEPA. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substances for a significant new activity as defined in this Order.

When the Department of the Environment or Health Canada suspect that certain new activities in relation to the substance may result in the substance becoming toxic, the SNAc provisions under CEPA are applied to the substance to ensure that adequate additional information is provided by the notifier or any other proponent who wishes to manufacture, import or use the substance for the significant new activities specified in the Order. A Significant New Activity Notification (SNAN) containing all prescribed information specified in the Order must then be provided within the prescribed time and prior to undertaking a significant new activity.

An order amending the DSL is a legal instrument adopted by the Minister of the Environment. Order 2018-87-02-01 applies the SNAc provisions of that CEPA to 2-propanol, 1-[bis(2-hydroxyethyl)amino]-, CAS RN 6712-98-7. The Order is now in force. It is therefore mandatory to meet all the requirements of the Order should a person intend to use the substance for a significant new activity as defined in the Order. ^{footnote 12}

An order adding a substance to the DSL does not constitute an endorsement from the Department of the Environment or the Government of Canada of the substance to which it relates, or an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.

Applicability of the significant new activities

The Order requires that any person (individual or corporation) engaging in a significant new activity in relation to 2-propanol, 1-[bis(2-hydroxyethyl)amino]-, CAS RN 6712-98-7, submit a SNAN containing all of the information prescribed in the Order at least 90 days prior to using the substance for the significant new activity.

In order to address human health concerns, the Order targets the use of the substance 2-propanol, 1-[bis(2-hydroxyethyl)amino]- in consumer products to which the Canada Consumer Product Safety Act ^{footnote 13} (CCPSA) applies, in natural health products as defined in subsection 1(1) of the Natural Health Products Regulations,^{footnote 14} or any drug as defined in the Food and Drugs Act, ^{footnote 15} and in cosmetics as defined in section 2 of the Food and Drugs Act.

A SNAN is required for the manufacture of such products with the substance in such a manner that the substance is present in a concentration that is greater than or equal to 0.1% by weight in the product.

For any other activity related to any of these products, notification is required when, during a calendar year, the total quantity of the substance in the product is greater than 10 kg and present in a concentration that is greater or equal to 0.1% by weight. For example, a notification is required if a person plans to use a consumer product (e.g. paint) in which the substance is present in a concentration that is greater or equal to 0.1% by weight and where there is more than 10 kg of the substance involved in a calendar year. Examples of products of concern include, but are not limited to, paints, coatings, adhesives, sealants and epoxies. The substance is not known to be currently used in consumer products, natural health products, drugs or cosmetics in Canada.

Activities that are not significant new activities

The following activities are not significant new activities: activities involving the use of the substance as a research and development substance, a site-limited intermediate or an export-only substance are excluded from the Order.^{footnote 16}

Activities involving the use of the substance in products to which the CCPSA does not apply, with the exception of natural health products within the meaning of subsection 1(1) of the Natural Health Products Regulations, and other drugs and cosmetics within the meaning of section 2 of the Food and Drugs Act are also excluded from the application of the SNAc provisions of CEPA.

Uses of the substance that are regulated under the acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, ^{footnote 17} the Fertilizers Act ^{footnote 18} and the Feeds Act ^{footnote 19} are also excluded from the application of the SNAc provisions of CEPA. The Order also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the SNAc provisions of CEPA. See subsection 81(6) and section 3 of CEPA, and section 3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers for additional information.

Information to be submitted

The Order sets out the information that must be provided to the Minister 90 days before the day on which the substance 2-propanol, 1-[bis(2-hydroxyethyl)amino]-, CAS RN 6712-98-7, is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received.

The earlier assessment of the substance identified concerns associated with potential activities and human chronic exposure that could result in systemic and developmental toxicity to the consumer. The SNAc provisions of CEPA are applied to the substance to obtain information to ensure that the substance will undergo further assessment before significant new activities are undertaken.

The information requirements in the Order relate to general information in respect of the substance, details surrounding its use, exposure information, and developmental and reproductive toxicity data in respect of the substance. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Consultation

As the orders are administrative in nature, no consultation was deemed necessary.

Rationale

Substances new to Canada are subject to notification and assessment requirements before they can be manufactured or imported over the thresholds set in the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). These regulations were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds are risk assessed to identify potential hazards to the environment and human health and that appropriate control measures are taken, if deemed necessary.

The Government assessed information on 28 substances new to Canada, and determined that they meet the criteria for their addition to the DSL. These substances have been added to the DSL and therefore they are exempt from notification and assessment requirements under sections 81, 83, 106 and 108 of the Act.

Due to potential human health concerns, SNAc requirements for the substance CAS RN 6712-98-7 have been maintained as the substance was added to the DSL. This will enable the Government to assess the risks associated with significant new activities involving this substance before they are undertaken.

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

The orders do not trigger the “One-for-One” Rule, as they do not add any additional costs to business. Also, the small business lens does not apply to the orders, as they do not add any administrative or compliance burden to 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 or when SNAc requirements are maintained.

When assessing whether or not a substance is subject to SNAc provisions ^{footnote 20} of CEPA, a person is expected to make use of information in their possession or to which they ought to have access. The phrase “to which they ought to have access” 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, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheets (SDSs). ^{footnote 21}

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. Therefore, an SDS may not list all product ingredients that may be subject to the SNAc provisions of CEPA due to human health or environmental concerns. 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 DSL through these orders is toxic or capable of becoming toxic, the person who is in possession 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. For example, in cases where a person takes 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 submitted by the person from whom they obtained the substance. 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” ^{footnote 22} provides more detail on this subject.

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

Where a person has questions concerning their obligations to comply with an order, believes they may be out of compliance, or would like to request a PNC, they are encouraged to discuss their particular circumstances with the program by contacting the Substances Management Information Line. ^{footnote 23}

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. ^{footnote 24} In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.

Contact