ARCHIVED — Vol. 150, No. 17 — August 24, 2016

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Registration

SOR/2016-229 August 5, 2016

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2016-112-08-01 Amending the Domestic Substances List

Whereas the Minister of the Environment has been provided with information under paragraph 112(1)(a) of the Canadian Environmental Protection Act, 1999 (see 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 (see 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 under the New Substances Notification Regulations (Organisms) (see 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 subsections 112(1) and (3) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2016-112-08-01 Amending the Domestic Substances List.

Gatineau, July 27, 2016

Catherine McKenna
Minister of the Environment

Order 2016-112-08-01 Amending the Domestic Substances List

Amendment

1 Part 6 of the Domestic Substances List (see footnote 1) is amended by adding the following in alphabetical order:

Column 1



Living Organism

Column 2


Significant new activity for which living organism is subject to subsection 106(3) of the Act

Saccharomyces cerevisiae expressing pyruvate formate lyase activating enzyme, pyruvate formate lyase and bifunctional acetaldehyde-CoA/alcohol dehydrogenase from Bifidobacterium adolescentis and a glucoamylase from Saccharomycopsis fibuligera S

  • 1 Any use of the living organism identified as Saccharomyces cerevisiae expressing pyruvate formate lyase activating enzyme, pyruvate formate lyase and bifunctional acetaldehyde- CoA/alcohol dehydrogenase from Bifidobacterium adolescentis and a glucoamylase from Saccharomycopsis fibuligera, other than its use
    • (a) for the production of bioethanol;
    • (b) for purposes of bioremediation;
    • (c) for the production of enzymes or biochemicals; or
    • (d) as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms).
  • 2 For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the day on which it begins:
    • (a) a description of the significant new activity in relation to the living organism;
    • (b) the information specified in items 2 and 3 and paragraph 6(e) of Schedule 1 to the New Substances Notification Regulations (Organisms);
    • (c) the information specified in paragraph 6(c) of Schedule 1 to the New Substances Notification Regulations (Organisms), consisting of data from a test of pathogenicity specifically designed to determine the potential adverse effects of the living organism in immuno-compromised mice or an alternate immuno-compromised animal;
    • (d) all other information and test data in respect of the living organism that are in the possession of the person who is proposing to conduct the significant new activity, or to which they have access, and that are relevant to determining whether the living organism is toxic or capable of becoming toxic;
    • (e) the identification of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the living organism and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the living organism imposed by the department or agency; and
    • (f) a description or specification of the test procedures followed in developing the test data, including the test methods, reference substances and quality control and quality assurance procedures.
  • 3 The information provided under section 2 will be assessed within 120 days after the day on which it is received by the Minister.

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) amended the Domestic Substances List (DSL) by

  1. Adding 25 substances and maintaining Significant New Activity (SNAc) (see footnote 2) requirements under the Canadian Environmental Protection Act, 1999 (CEPA) related to one of these substances — Order 2016-87-08-01 Amending the Domestic Substances List;
  2. Adding one living organism and maintaining SNAc requirements under CEPA related to this living organism — Order 2016-112-08-01 Amending the Domestic Substances List; and
  3. Updating the identifier of a substance already on the DSL — Order 2016-66-08-01 Amending the Domestic Substances List.

Background

Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under CEPA, substances (i.e. chemicals, polymers, nanomaterials, and living organisms) “new” to Canada are subject to reporting requirements before they can be manufactured or imported. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate.

The DSL is an inventory of substances in the Canadian marketplace. Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in subsections 81(1) and 106(1) of CEPA as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). These requirements do not apply to substances listed on the DSL.

Under subsection 87(3) or 112(3) of CEPA, reporting obligations may be imposed in relation to significant new activities with substances being added to the DSL, if the Government deems it necessary based on available information. The information submitted enables the Government to assess risks associated with proposed new uses and determine whether additional risk management is required.

The DSL was published in the Canada Gazette, Part II, in May 1994 (see footnote 3) and is amended on average 10 times a year to add or delete substances.

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 conditions are met:

  • the Minister of the Environment has been provided with information regarding the substance; (see footnote 4)
  • the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada under the conditions set out in section 87 or 112 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.
Order 2016-87-08-01 Amending the Domestic Substances List

The Government assessed information on 25 new chemicals and polymers reported to the New Substances Program and determined that they meet the conditions for their addition to the DSL. These substances have therefore been added to the DSL under this Order.

The assessment of one of these 25 substances (Chemical Abstracts Service Registry No. [CAS RN] 68956-82-1) identified potential human health concerns related to a strong potential for dermal sensitization, a moderate sub-chronic toxicity, and a carcinogenic potential in certain exposure scenarios. For these reasons, the significant new activity provisions of CEPA were applied to the substance in June 2010, (see footnote 5) before its addition to the DSL. The Government later determined that this substance meets the conditions for addition to the DSL and it has therefore been added to the DSL under this Order. SNAc requirements were also added to the DSL to maintain the reporting obligations on the substance.

Objectives

The objectives of this Order are to

  • comply with the requirements under subsections 87(1) and 87(5) of CEPA by adding 25 substances to the DSL, making them no longer subject to the notification and assessment requirements as set out in subsection 81(1) of CEPA and in the New Substances Notification Regulations (Chemicals and Polymers); and
  • contribute to the protection of human health by maintaining the SNAc requirements on the substance CAS RN 68956-82-1 and enabling the Government to assess the risks associated with proposed significant new activities involving the substance before they are undertaken.

Description

This Order added a total of 25 substances to the DSL: 11 substances were added to Part 1 of the DSL, one substance to Part 2 of the DSL, and 13 substances to Part 3 of the DSL. To protect confidential business information, 13 of the 25 substances have masked chemical names. (see footnote 6)

This Order also indicated that one of the 25 substances (CAS RN 68956-82-1) is subject to the SNAc provisions under CEPA. This Order has been registered and is in force. 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 this Order.

According to the requirements of subsection 81(3) of CEPA, any person who intends to use, manufacture or import the substance for a significant new activity must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to the beginning of the significant new activity.

The significant new activities requiring a SNAN submission are defined as any use of the substance in a consumer product to which the Canada Consumer Product Act applies, in any quantity, where the concentration of the substance in the final product exceeds 0.1% by weight.

The requirements of subsection 81(3) of CEPA do not apply to uses of the substance that are regulated under any of the following Acts of Parliament listed in Schedule 2 of CEPA: the Pest Control Products Act, the Fertilizers Act and the Feeds Act. They also do not apply to transient reaction intermediates that are not isolated and are not likely released; impurities, contaminants or partially unreacted materials related to the preparation of a substance; 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 notifiable under subsection 81(3) of CEPA. See subsection 81(6) and section 3 of CEPA, and section 3.2 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) for additional details. (see footnote 7)

Information must be provided to the Minister of the Environment 90 days prior to the beginning of the 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.

Order 2016-112-08-01 Amending the Domestic Substances List

The Government assessed information on one new living organism reported to the New Substances Program. The assessment identified potential human health concerns related to the moderate virulence and hazard potential of the living organism strain. Because of its moderate virulence in immuno-competent mice, there is a likelihood that the living organism could cause adverse effects in vulnerable individuals with compromised immunity or with underlying diseases or medical conditions. For these reasons, the SNAc provisions under CEPA were applied to the living organism in June 2016, (see footnote 8) before its addition to the DSL. The Government later determined that this living organism meets the conditions for addition to the DSL and it was therefore added to the DSL under this Order. SNAc requirements were also added to the DSL to maintain the reporting obligations on the living organism.

Objectives

The objectives of this Order are to

  • comply with the requirements under subsection 112(1) of CEPA by adding one living organism to the DSL, making it no longer subject to the notification and assessment requirements as set out in subsection 106(1) of CEPA and in the New Substances Notification Regulations (Organism); and
  • contribute to the protection of human health by maintaining the SNAc requirements on the living organism and enabling the Government to assess the risks associated with proposed new significant activities involving the living organism before they are undertaken.

Description

This Order added one living organism identified as Saccharomyces cerevisiae expressing pyruvate formate lyase activating enzyme, pyruvate formate lyase, and bifunctional acetaldehyde- CoA/alcohol dehydrogenase from Bifidobacterium adolescentis and a glucoamylase from Saccharomycopsis fibuligera to Part 6 of the DSL while indicating this living organism is subject to the SNAc provisions under CEPA. This Order has been registered and is in force. It is therefore mandatory to meet the requirements of subsection 106(3) of CEPA before manufacturing, importing or using the living organism for a significant new activity as defined in this Order.

According to the requirements of subsection 106(3) of CEPA, any person who intends to use, manufacture or import the living organism for a significant new activity must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 120 days prior to the beginning of the significant new activity.

The significant new activities requiring a SNAN submission are defined as any use of the living organism, other than its use

  • (a) for the production of bioethanol;
  • (b) for purposes of bioremediation;
  • (c) for the production of enzymes or biochemicals; and
  • (d) as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms).

Significant new activities requiring a SNAN include, but are not limited to, uses of the living organism to produce food and drug products, soil conditioners, microbial-based cleaning products, home deodorizers, aquarium and pond cleaning products, and waste water treatment products.

The requirements of subsection 106(3) of CEPA do not apply to uses of the substance that are regulated under any of the following Acts of Parliament listed in Schedule 4 of CEPA: the Pest Control Products Act, the Seeds Act, the Fertilizers Act, the Feeds Act, and the Health of Animals Act. They also do not apply to impurities or contaminants related to the preparation of a living organism 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 notifiable under subsection 106(3) of CEPA. See section 3 and subsection 106(6) of CEPA, and section 2.5 of the Guidelines for the Notification and Testing of New Substances: Organisms for additional details. (see footnote 9)

Information must be provided to the Minister of the Environment 120 days prior to the beginning of the 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 120 days after the complete information is received.

Order 2016-66-08-01 Amending the Domestic Substances List

In 1999, the Government assessed information on the substance CAS RN 68081-85-6 and determined that it met the criteria for addition to the DSL. The substance was therefore added to the DSL in March 1999. (see footnote 10) New information provided to the Government indicated that a more accurate identifier was available for this substance, i.e. CAS RN 188493-82-5. The substance identifier on the DSL has therefore been updated under this Order.

Objectives

The objective of this Order is to update a substance identifier on the DSL.

Description

This Order deleted CAS RN 68081-85-6 from Part 1 of the DSL and added CAS RN 188493-82-5 to Part 1 of the DSL.

The following information applies to the three orders (Order 2016-87-08-01 Amending the Domestic Substances List, Order 2016-112-08-01 Amending the Domestic Substances List, and Order 2016-66-08-01 Amending the Domestic Substances List).

Consultation

As the orders do not contain any information expected to generate comments or objections by stakeholders, no consultation is deemed necessary.

Rationale

The Government assessed information on 26 new substances (25 chemicals and polymers, and one living organism) reported to the New Substances Program and determined that they meet the conditions for their addition to the DSL. These substances have therefore been added to the DSL.

The assessment of 2 of these 26 substances (one chemical and one living organism) identified potential human health concerns. SNAc requirements have therefore been added to the DSL for these 2 substances. This will enable the Government to assess the risks associated with significant new activities involving these substances before they are undertaken.

A more accurate identifier was available for one substance already on the DSL. The substance identifier has therefore been updated on the DSL.

The orders will benefit Canadians by enabling industry to have better access to larger quantities of these substances, which is expected to reduce costs associated with products consumed by Canadians. It is expected that there will be no incremental costs to the public, industry or governments associated with the orders.

“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

The DSL identifies substances that, for the purposes of CEPA, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). Reporting obligations may be imposed or maintained on substances being added to the DSL under the SNAc provisions of CEPA. Developing an implementation plan and a compliance strategy or establishing a service standard is not required when adding substances to the DSL, maintaining SNAc requirements on substances being added to the DSL, or updating a substance identifier on the DSL.

When assessing whether or not a particular activity meets the definition of significant new activity on the DSL, a person is expected to make use of information in their possession or to which they ought to have access. (see footnote 11) The phrase “to which they ought to have access” means information in any of the company’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 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. Therefore, an SDS may not list all substances that may be subject to SNAc provisions due to public 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 the substance is toxic or capable of becoming toxic, the person who obtains the information and is involved in activities with the substance is obligated, under section 70 of CEPA, to provide that information to the Minister of the Environment without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession and control of the substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by the 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. (see footnote 12)

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the New Substances 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 the orders or 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. (see footnote 13)

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 14) 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

Greg Carreau
Executive Director
Program Development and Engagement Division
Environment Canada
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