Order 2021-112-16-01 Amending the Domestic Substances List: SOR/2021-253

Canada Gazette, Part II, Volume 156, Number 1

Registration
SOR/2021-253 December 17, 2021

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 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 subsections 112(1) and (3) of the Canadian Environmental Protection Act, 1999 ^{footnote a}, makes the annexed Order 2021-112-16-01 Amending the Domestic Substances List.

Gatineau, December 15, 2021

Steven Guilbeault
Minister of the Environment

Order 2021-112-16-01 Amending the Domestic Substances List

Amendments

1 Part 5 of the Domestic Substances List ^{footnote b} is amended by adding the following in alphabetical order under the heading “Organisms/Organismes”:

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 N

2 (1) Part 6 of the List is amended by deleting the living organism “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” in column 1 and the Significant New Activity in column 2 opposite the reference to that living organism.

(2) Part 6 of the List 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
Bacillus subtilis strain HF2 N-S	1 Any use of the living organism Bacillus subtilis strain HF2, other than its use (a) for maintaining grease traps in commercial establishments or drains that are connected to a municipal wastewater system; (b) for cleaning floors in commercial establishments; (c) for controlling odours in dumpsters and trash compactors; or (d) for treating water in any artificial aquatic environment, such as aquariums and ornamental ponds. 2 Despite section 1, the following do not constitute a significant new activity: (a) the use of the living organism in an agricultural research study, as defined in subsection 2.1(2) of the New Substances Notification Regulations (Organisms), that meets all of the conditions set out in paragraphs 2.1(1)(a) to (e) of those Regulations; (b) the use of the living organism as a research and development organism in a contained facility, as those terms are defined in subsection 1(1) of those Regulations, if the living organism is not for introduction outside that facility and (i) is imported to the contained facility in a quantity that, at the time of the importation, is less than 50 mL or 50 g, or (ii) is manufactured in the contained facility and present in that facility in a quantity that, at any given moment, is less than 1 000 L; (c) the use of the living organism for the production of a substance in a contained facility, as defined in subsection 1(1) of those Regulations, if the living organism is not for introduction outside that facility; or (d) the sale and distribution of the living organism for the uses referred to in paragraphs 1(a) to (d). 3 For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the activity begins: (a) a description of the significant new activity in relation to the living organism; (b) the information specified in items 2 and 3 of Schedule 1 to the New Substances Notification Regulations (Organisms); (c) the data and a report from a study in respect of the living organism conducted in accordance with the methods described in section 10 of the December 2016 version of Report EPS 1/RM/44, Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms, prepared by the Minister, to determine the effects of the living organism alone on aquatic invertebrate species likely to be exposed to it in the course of the significant new activity; (d) the data and a report from a study in respect of the living organism conducted in accordance with the methods described in section 13 of the December 2016 version of Report EPS 1/RM/44, Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms, prepared by the Minister, to determine the effects of the living organism alone on terrestrial invertebrate species likely to be exposed to it in the course of the significant new activity; (e) a description of the procedures followed in developing the data mentioned in paragraphs (c) and (d), including a description or copy of the test methods used and of the quality control and quality assurance procedures followed in developing the data; (f) all other information and data in respect of the living organism that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the living organism; (g) the name 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 file number of the department or agency and, if any, the outcome of the assessment of the department or agency and the risk management actions in relation to the living organism imposed by the department or agency; (h) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person who is proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; (i) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the head of the quality assurance unit of every laboratory that developed data that was submitted for the purposes of this section; and (j) a certification that the information is accurate and complete, dated and signed by the person who is proposing the significant new activity if they are resident in Canada or, if they are not resident in Canada, by the person resident in Canada who is authorized to act on their behalf. 4 The studies referred to in paragraphs 3(c) and (d) must be conducted in accordance with the Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the Organisation for Economic Co-operation and Development on May 12, 1981, that are current at the time the studies are conducted. 5 The information provided under section 3 is to be assessed within 120 days after the day on which it is received by the Minister.
Bacillus subtilis strain 43B6r N-S	1 Any use of the living organism Bacillus subtilis strain 43B6r, other than its use (a) for maintaining grease traps in commercial establishments or drains that are connected to a municipal wastewater system; (b) for cleaning floors in commercial establishments; (c) for controlling odours in dumpsters and trash compactors; or (d) for treating water in any artificial aquatic environment, such as aquariums and ornamental ponds. 2 Despite section 1, the following do not constitute a significant new activity: (a) the use of the living organism in an agricultural research study, as defined in subsection 2.1(2) of the New Substances Notification Regulations (Organisms), that meets all of the conditions set out in paragraphs 2.1(1)(a) to (e) of those Regulations; (b) the use of the living organism as a research and development organism in a contained facility, as those terms are defined in subsection 1(1) of those Regulations, if the living organism is not for introduction outside that facility and (i) is imported to the contained facility in a quantity that, at the time of the importation, is less than 50 mL or 50 g, or (ii) is manufactured in the contained facility and present in that facility in a quantity that, at any given moment, is less than 1 000 L; (c) the use of the living organism for the production of a substance in a contained facility, as defined in subsection 1(1) of those Regulations, if the living organism is not for introduction outside that facility; or (d) the sale and distribution of the living organism for the uses referred to in paragraphs 1(a) to (d). 3 For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the activity begins: (a) a description of the significant new activity in relation to the living organism; (b) the information specified in items 2 and 3 of Schedule 1 to the New Substances Notification Regulations (Organisms); (c) the data and a report from a study in respect of the living organism conducted in accordance with the methods described in section 10 of the December 2016 version of Report EPS 1/RM/44, Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms, prepared by the Minister, to determine the effects of the living organism alone on aquatic invertebrate species likely to be exposed to it in the course of the significant new activity; (d) the data and a report from a study in respect of the living organism conducted in accordance with the methods described in section 13 of the December 2016 version of Report EPS 1/RM/44, Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms, prepared by the Minister, to determine the effects of the living organism alone on terrestrial invertebrate species likely to be exposed to it in the course of the significant new activity; (e) a description of the procedures followed in developing the data mentioned in paragraphs (c) and (d), including a description or copy of the test methods used and of the quality control and quality assurance procedures followed in developing the data; (f) all other information and data in respect of the living organism that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the living organism; (g) the name 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 file number of the department or agency and, if any, the outcome of the assessment of the department or agency and the risk management actions in relation to the living organism imposed by the department or agency; (h) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person who is proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; (i) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the head of the quality assurance unit of every laboratory that developed data that was submitted for the purposes of this section; and (j) a certification that the information is accurate and complete, dated and signed by the person who is proposing the significant new activity if they are resident in Canada or, if they are not resident in Canada, by the person resident in Canada who is authorized to act on their behalf. 4 The studies referred to in paragraphs 3(c) and (d) must be conducted in accordance with the Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the Organisation for Economic Co-operation and Development on May 12, 1981, that are current at the time the studies are conducted. 5 The information provided under section 3 is to be assessed within 120 days after the day on which it is received by the Minister.

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 Order.)

Issues

The Minister of the Environment and the Minister of Health (the ministers) assessed information on two substances (living organisms) 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 section 112 of CEPA, the Minister of the Environment (the Minister) is adding two living organisms to the Domestic Substances List.

The ministers identified potential environmental concerns if these two living organisms were to be used in certain new activities. Those living organisms are

• Bacillus subtilis strain HF2
• Bacillus subtilis strain 43B6r

In order to address these potential environmental concerns, the Minister is applying the Significant New Activity (SNAc) provisions of CEPA to these two living organisms.

Furthermore, the ministers determined that the potential risks to human health and the environment associated with significant new activities involving the living organism 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 are negligible to low and therefore, the Minister is rescinding SNAc requirements concerning this living organism.

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 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 Guidance Document for the Notification and Testing of New 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 [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 Chemical Abstracts Service (CAS) Registry Numbers, ^{footnote 1} or their Substance Identity Numbers assigned by the Department of the Environment and the names of the substance.

Part 2

Sets out chemicals and polymers subject to SNAc requirements that are identified by their CAS Registry Numbers.

Part 3

Sets out chemicals and polymers, except those referred to in Part 4, that are identified by their masked names and their Confidential Accession Numbers (CANs) assigned by the Department of the Environment.

Part 4

Sets out chemicals and polymers subject to SNAc requirements that are identified by their masked names and their CANs.

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) numbers, International Union of Biochemistry and Molecular Biology (IUBMB) numbers or specific substance names.

Part 6

Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their ATCC numbers, IUBMB numbers or specific substance names.

Part 7

Sets out inanimate biotechnology products and living organisms, except those referred to in Part 8, that are identified by their masked names and their CANs.

Part 8

Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their masked names and their CANs.

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 kilograms 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:

• the Minister has been provided with the regulatory information regarding the substance. The information to be provided is set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms);
• the ministers are satisfied that the substance has already been manufactured in, or imported into, Canada in the prescribed quantity or conditions by the person who provided the information;
• the period prescribed under section 83 or 108 of CEPA 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.

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

Amendments to the Domestic Substances List may also add, vary or rescind reporting obligations imposed under the SNAc provisions of CEPA. 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 visit the Canada.ca Open Data Portal.

Adding two living organisms to the Domestic Substances List

The ministers assessed information on two substances (living organisms) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List, under subsection 112(1) of CEPA. These two living organisms are therefore being added to the Domestic Substances List and, as a result, are no longer subject to the New Substances Notification Regulations (Organisms).

In addition, these two living organisms, identified as Bacillus subtilis strain HF2 and Bacillus subtilis strain 43B6r are being subject to the SNAc provisions of CEPA.

In order to address potential environmental concerns if the two living organisms were to be used in certain new activities resulting in their release to natural aquatic or terrestrial environments, the Minister is applying the SNAc provisions of CEPA to these living organisms. Potential environmental concerns were identified because these two living organisms may cause adverse effects to aquatic and terrestrial invertebrates.

Therefore, the SNAc requirements on these two living organisms are being added with the two living organisms to the Domestic Substances List.

Rescinding SNAc requirements on one living organism

In January 2015, a public commitment was made by the Department of the Environment and the Department of Health to review all SNAc requirements that were adopted between 2001 and 2014. The purpose of the review is to ensure that SNAc requirements are consistent with current information, policies and approaches. Resulting changes to SNAc requirements are expected to provide greater clarity of scope and improved ease of compliance, while protecting Canadians and their environment.

As part of this review, the ministers determined that the potential risks to human health and the environment associated with significant new activities involving the living organism 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 are negligible to low.

As a result, the SNAc requirements on this substance are no longer warranted and are thus removed from the Domestic Substances List.

Objective

The objective of Order 2021-112-16-01 Amending the Domestic Substances List (the order) is to add two living organisms to the Domestic Substances List and to contribute to the protection of the environment by applying the SNAc provisions of CEPA to these two living organisms identified as Bacillus subtilis strain HF2 and Bacillus subtilis strain 43B6r. The order requires that the Minister be notified of any significant new activity involving the two living organisms Bacillus subtilis strain HF2 and Bacillus subtilis strain 43B6r so that further assessment of the living organisms are conducted, and, if necessary, risk management measures are implemented before the activity is undertaken.

Another objective of the order is to rescind the SNAc requirements concerning 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, as the assessment conclusions regarding this living organism have been updated.

The order is expected to facilitate access to the two living organisms Bacillus subtilis strain HF2 and Bacillus subtilis strain 43B6r for businesses as the living organisms are no longer subject to requirements under subsection 106(1) of CEPA.

Description

The order is made pursuant to subsection 112(1) and 112(3) of CEPA to add two substances (living organisms) along with SNAc requirements to Part 6 of the Domestic Substances List and to rescind SNAc requirements for another living organism.

The SNAc provisions of CEPA apply to the living organism Bacillus subtilis strain HF2 and the living organism Bacillus subtilis strain 43B6r. It is therefore mandatory to meet the requirements of subsection 106(3) of CEPA before manufacturing, importing or using the two living organisms Bacillus subtilis strain HF2 and the substance Bacillus subtilis strain 43B6r for a significant new activity as defined in the order.

The SNAc provisions of CEPA no longer apply to the living organism 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.

SNAc applicability and reporting requirements

Under the order, any person wishing to engage in a significant new activity in relation to the living organism Bacillus subtilis strain HF2 or the living organism Bacillus subtilis strain 43B6r 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 120 days prior to the manufacture, import or use of the living organism for the proposed significant new activity. The ministers will use the information submitted to conduct further assessment of the living organism, and, if necessary, implement risk management measures before the activity is undertaken.

Activities subject to notification requirements for Bacillus subtilis strain HF2 and Bacillus subtilis strain 43B6r

The notification requirements apply to any use of the substance (living organism) other than its use

• for maintaining grease traps in commercial establishments or drains that are connected to a municipal wastewater system;
• for cleaning floors in commercial establishments;
• for controlling odours in dumpsters and trash compactors; or
• for treating water in any artificial aquatic environment, such as aquariums and ornamental ponds.

Activities not subject to notification requirements for Bacillus subtilis strain HF2 and Bacillus subtilis strain 43B6r

The notification requirements do not apply to

1. the use of the living organism in an agricultural research study, as defined in subsection 2.1(2) of the New Substances Notification Regulations (Organisms), that meets all of the conditions set out in paragraphs 2.1(1)(a) to (e) of those Regulations;
2. the use of the living organism as a research and development organism in a contained facility, as those terms are defined in subsection 1(1) of those Regulations, if the living organism is not for introduction outside that facility and is
   • imported to the contained facility in a quantity that, at the time of the importation, is less than 50 mL or 50 g, or
   • manufactured in the contained facility and present in that facility in a quantity that, at any given moment, is less than 1 000 L;
3. the use of the living organism for the production of a substance in a contained facility, as defined in subsection 1(1) of those Regulations, if the living organism is not for introduction outside that facility; or
4. the sale and distribution of the living organism for the following uses:
   • maintaining grease traps in commercial establishments or drains that are connected to a municipal wastewater system;
   • cleaning floors in commercial establishments;
   • controlling odours in dumpsters and trash compactors; or
   • treating water in any artificial aquatic environment, such as aquariums and ornamental ponds.

Information requirements

The information required under the order relates to details surrounding the significant new activities, the introduction of the living organism in the environment following the new activity and the effects of the living organism on aquatic and terrestrial invertebrates. Some of the information requirements reference the New Substances Notification Regulations (Organisms).

The information required to complete a SNAN is unique to each substance and is described within the order.

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 order 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 allow the Minister to comply with this obligation.

Applying the SNAc provisions of CEPA on substances is considered when there is suspicion that new activities 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 two living organisms 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 112 of CEPA that is triggered once a substance meets the criteria for addition. Maintaining the SNAc provisions of CEPA on the living organism Bacillus subtilis strain HF2 or the living organism Bacillus subtilis strain 43B6r continues contributing to the protection of the environment by requiring that potential significant new activities involving the living organisms undergo further assessment, and that, if necessary, risk management measures are implemented before the activity is undertaken. The order does not impose any regulatory requirements (and therefore, any administrative of compliance costs) on businesses related to current activities. The order would continue to only target significant new activities involving the living organism Bacillus subtilis strain HF2 or the living organism Bacillus subtilis strain 43B6r, should any person choose to pursue such an activity. In the event that any person wishes to use, import, or manufacture the living organisms for a significant new activity, they would be required to submit a SNAN to the Minister containing the complete information referred to in the order.

While there is no notification fee associated with submitting a SNAN to the Minister in response to the order, the notifier may incur 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 order.

Small business lens

The assessment of the small business lens concluded that the order has no impact on small businesses, as it does not impose any administrative or compliance costs on businesses related to current activities.

One-for-one rule

The assessment of the one-for-one rule concluded that the rule does not apply to the order, as there is no impact on industry related to current activities.

Regulatory cooperation and alignment

There are no international agreements or obligations directly associated with the order.

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 order.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for the order.

Implementation, compliance and enforcement, and service standards

Implementation

The order is now in force. Developing an implementation plan is not required when adding substances to the Domestic Substances List. The order does not constitute an endorsement from the Government of Canada of the living organisms 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 living organisms or to activities involving them.

Compliance and enforcement

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 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 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.

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 PNC, they are encouraged to contact the Substances Management Information Line at substances@ec.gc.ca (email), 1‑800‑567‑1999 (toll-free in Canada), or 819‑938‑3232 (outside of Canada).

The order is made under the authority of CEPA, which is enforced in accordance with the Canadian Environmental Protection Act: compliance and enforcement policy. 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 enviroinfo@ec.gc.ca.

Service standards

In the event that a SNAN is submitted to the Minister in relation to the living organism Bacillus subtilis strain HF2 or the living organism Bacillus subtilis strain 43B6r, the ministers will assess the information after the complete information is received, within the prescribed timelines set out in the order.

Contact

Thomas Kruidenier
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: substances@ec.gc.ca