Order 2018-112-07-01 Amending the Domestic Substances List: SOR/2018-271

Canada Gazette, Part II, Volume 152, Number 26

Registration

SOR/2018-271 December 7, 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 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 2018-112-07-01 Amending the Domestic Substances List.

Gatineau, December 4, 2018

Catherine McKenna
Minister of the Environment

Order 2018-112-07-01 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”:

Replication-incompetent chimpanzee-derived Simian mastadenovirus C serotype 155 expressing human respiratory syncytial virus A2 (HRSV-A2) antigens F, N and M2-1

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 six substances new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government added five substances to the DSL under the Order 2018-87-07-01 Amending the Domestic Substances List (Order 2018-87-07-01) and one substance is added under the Order 2018-112-07-01 Amending the Domestic Substances List (Order 2018-112-07-01).

The Government identified potential human health and environmental concerns if one of the six substances (Chemical Abstract Service Registry Number [CAS RN] 69009-90-1) is used in certain new activities. For this reason, the significant new activity (SNAc) provisions under the Canadian Environmental Protection Act, 1999 (CEPA) were applied to the substance before its addition to the DSL. As this substance is added to the DSL under Order 2018-87-07-01, reporting obligations under the SNAc provisions of CEPA were maintained under the same Order.

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 CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). 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 are risk assessed to identify potential hazards 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 of 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) is an inventory of substances in the Canadian marketplace published in the Canada Gazette, Part II, in May 1994. The current structure of the DSL was established in June 2001 (The Order 2001-87-04-01 Amending the Domestic Substances List [SOR/2001-214], published in the Canada Gazette, Part II, in July 2001, establishes the structure of the DSL) and it includes 8 Parts defined as follows:

Criteria for addition of substances to the DSL

The DSL is amended on average 10 times a 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, 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.

A living organism must be added to the DSL under section 105 of CEPA 1999 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 the legislature 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:

Criteria for adding, varying or rescinding SNAc provisions of CEPA for substances to be added or already on the DSL

Amendments to the DSL may also add, vary, or rescind reporting obligations imposed under the SNAc provisions of CEPA. 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 activity involving substances before they are undertaken in Canada and determine whether additional risk management may be required.

Adding six substances to the DSL

The Government assessed information on six new substances (five chemicals and polymers, and one organism) reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL, under subsections 87(5) and 112(1) of CEPA. These six 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.

One of the six substances was subjected to SNAc provision under CEPA: 1,1′-biphenyl, bis(1-methylethyl)-, (CAS RN 69009-90-1).

In June 2017, the Significant New Activity Order No. 19046 was published in the Canada Gazette, Part I, Vol. 151, No. 25 and set out the reporting requirements.

SNAc provision were applied to this substance as the Government identified potential environmental and human health concerns if this substance is used in certain new activities. In order to maintain the reporting obligations associated with this substance, SNAc requirements are carried over as this substance is added to the DSL under Order 2018-87-07-01.

Objectives

Order 2018-87-07-01 is made pursuant to subsections 87(3) and 87(5) of CEPA to add five substances (chemicals and polymers) to the DSL and maintain the SNAc requirements associated with the substance CAS RN 69009-90-1.

Order 2018-112-07-01 is made pursuant to subsection 112(1) of CEPA to add one substance (organism) to the DSL.

By adding 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 2018-87-07-01 adds five substances (chemicals and polymers) to the DSL and removes one substance’s masked name from the DSL:

The Order 2018-112-07-01 adds one substance (organism) identified by its specific substance name to Part 5 of the DSL.

In addition, under the Order 2018-87-07-01, the SNAc provisions of CEPA to 1,1′-biphenyl, bis(1-methylethyl)-, CAS RN 69009-90-1 are maintained. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using this substance for a significant new activity as defined in this Order. The Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 is available online.

When the Department of the Environment or the Department of Health suspect that certain new activities in relation to a 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 2018-87-07-01 must then be provided within the prescribed time and prior to undertaking a significant new activity regarding substances with CAS RN 69009-90-1.

An Order amending the DSL is a legal instrument adopted by the Minister of the Environment. The Order is now in force.

The following information pertains to SNAc requirements carried over for substance: 1,1′-biphenyl, bis(1- methylethyl)-, (CAS RN 69009-90-1):

Applicability of the SNAc

The Order requires that any person (individual or corporation) engaging in a significant new activity in relation to 1,1′-biphenyl, bis(1-methylethyl)-, Chemical Abstracts Service No. 69009-90-1, 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 to manufacture consumer products to which the Canada Consumer Product Safety Act (CCPSA) applies and cosmetics as defined in section 2 of the Food and Drugs Act. For the manufacture of such products, notification is required 90 days before use of the substance when the concentration of the substance in the product is 1% by weight or more.

For any other activity related to consumer products or cosmetics, notification is required when, during a calendar year, the total quantity of the substance in the product that is used is greater than 10 kg where it is present in a concentration that is greater than or equal to 1% by weight. For example, notification would be required if a person plans to use a consumer product (for example, paint) where the concentration of the substance in the product is 1% by weight or more and where there is more than 10 kg of the substance involved in a calendar year. Examples of products of concern would include, but would not be limited to, do-it-yourself products such as paints, coatings, adhesives, and sealants. Therefore, the use of the substance in such products as defined in the Order would require notification. The substance is not known to be currently used in consumer products or in cosmetics in Canada.

Activities not subject to the Order

Activities involving the use of the substance as a research and development substance, a site-limited intermediate or an export-only substance would be excluded from the Order. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers). An export-only substance is a substance that is manufactured or imported in Canada and destined solely for foreign markets.

This Order does not apply to products to which the CCPSA does not apply (see Annex A for the CCPSA definition of “consumer product” and exemptions), with the exception of cosmetics within the meaning of section 2 of the Food and Drugs Act. It also does not apply to uses of the substance that are regulated under the acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act. The Order also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted intermediates, or in some circumstances to items such as 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 1,1′-biphenyl, bis(1-methylethyl)-, Chemical Abstracts Service No. 69009-90-1, 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 assessment of the substance identified concerns associated with human health effects associated with necrosis of the liver and significant public exposure from potential new activities. The Order is issued 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 mammalian toxicity data in respect of the substance.

Additional guidance on preparing a SNAN can be found in section 4 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 six 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 and environmental concerns, SNAc requirements for substances CAS RN 69009-90-1 have been maintained as this substance was added to the DSL. This will enable the Government to assess the risks associated with significant new activities involving these substances 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 of CEPA, a person is expected to make use of information in their possession or to which they reasonably have access to. A comprehensive listing of substances that are subject to SNAc provisions is available online. Information to which a person reasonably has access to normally includes information in any of the person’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 formerly “Material Safety Data Sheets” (MSDSs). Please refer to the Regulations Amending the New Substances Notification Regulations (Chemicals and Polymers) and the Export of Substances on the Export Control List Regulations for reference to this amendment.

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

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.

The Order is now in force. It is therefore mandatory to meet all the requirements of the Order should a person intend to use one of these substances for a significant new activity as defined in the Order.

CEPA is enforced in accordance with the publicly available 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, 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