Order 2021-112-21-01 Amending the Domestic Substances List: SOR/2022-137

Canada Gazette, Part II, Volume 156, Number 13

Registration
SOR/2022-137 June 13, 2022

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the living organisms set out in the annexed Order are specified on the Domestic Substances List footnote a;

Therefore, the Minister of the Environment, pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order 2021-112-21-01 Amending the Domestic Substances List.

Gatineau, May 30, 2022

Steven Guilbeault
Minister of the Environment

Order 2021-112-21-01 Amending the Domestic Substances List

Amendments

1 Part 5 of the Domestic Substances List footnote a is amended by deleting the following under the heading “Organisms/Organismes”:

Aspergillus awamori
ATCC 22342

Aspergillus niger
ATCC9642

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

Aspergillus awamori

ATCC 22342 S′
  • 1 The use of the living organism Aspergillus awamori in a consumer product to which the Canada Consumer Product Safety Act applies or in a health care facility, such as a hospital, doctor’s office, walk-in clinic, mobile health clinic, long-term care facility or nursing home.
  • 2 Section 1 does not include the following activities:
    • (a) Aspergillus awamori is loaded on a conveyance outside of Canada, moving it through Canada to a location outside Canada, whether or not there is a change of conveyance during transit; and
    • (b) the use of Aspergillus awamori as a research and development organism, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms), if
      • (i) the organism is not for introduction outside of a contained facility and the conditions set out in subsection 2(3) of those Regulations are met, or
      • (ii) the organism is for introduction in an agricultural research study conducted on plants and the conditions set out in subsection 2.1(1) of those Regulations are met.
  • 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 significant new activity begins:
    • (a) a description of the significant new activity in relation to the living organism;
    • (b) the information specified in paragraphs 1(a) and (g), sections 2 and 3 and paragraph 6(e) of Schedule 1 to the New Substances Notification Regulations (Organisms);
    • (c) all other information and test 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 that the living organism presents to the environment and human health and the degree of environmental and public exposure to the living organism;
    • (d) the name of every government department or government 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;
    • (e) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity if they are resident in Canada or, if not, of the person resident in Canada authorized to act on their behalf;
    • (f) 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 test data or a report provided under this section; and
    • (g) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada authorized to act on their behalf.
  • 4 The information provided under section 3 is to be assessed within 120 days after the day on which it is received by the Minister.

Aspergillus brasiliensis

ATCC 9642 S’
  • 1 The use of the living organism Aspergillus brasiliensis in a consumer product to which the Canada Consumer Product Safety Act applies or in a health care facility, such as a hospital, doctor’s office, walk-in clinic, mobile health clinic, long-term care facility or nursing home.
  • 2 Section 1 does not include the following activities:
    • (a) Aspergillus brasiliensis is loaded on a conveyance outside of Canada, moving it through Canada to a location outside Canada, whether or not there is a change of conveyance during transit; and
    • (b) the use of Aspergillus brasiliensis as a research and development organism, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms), if
      • (i) the organism is not for introduction outside of a contained facility and the conditions set out in subsection 2(3) of those Regulations are met, or
      • (ii) the organism is for introduction in an agricultural research study conducted on plants and the conditions set out in subsection 2.1(1) of those Regulations are met.
  • 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 significant new activity begins:
    • (a) a description of the significant new activity in relation to the living organism;
    • (b) the information specified in paragraphs 1(a) and (g), sections 2 and 3 and paragraph 6(e) of Schedule 1 to the New Substances Notification Regulations (Organisms);
    • (c) all other information and test 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 that the living organism presents to the environment and human health and the degree of environmental and public exposure to the living organism;
    • (d) the name of every government department or government 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;
    • (e) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity if they are resident in Canada or, if not, of the person resident in Canada authorized to act on their behalf;
    • (f) 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 test data or a report provided under this section; and
    • (g) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada authorized to act on their behalf.
  • 4 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

Two living organisms from the Aspergillus genus have properties of concern that could pose a risk to the environment or human health in Canada if exposure levels to these living organisms were to increase due to certain new activities. In order to address this concern, the Minister of the Environment (the Minister) is amending the Domestic Substances List (DSL) in accordance with subsection 112(3) of the Canadian Environmental Protection Act, 1999 (CEPA) to apply the Significant New Activity (SNAc) provisions of CEPA to these living organisms. The two living organisms are

Background

The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and living organisms that may be harmful to the environment or human health. The Minister of the Environment and the Minister of Health (the Ministers) assessed A. awamori and A. brasiliensis in accordance with section 74 of CEPA as part of the CMP.

Description and uses

A. awamori and A. brasiliensis are naturally occurring fungi that have had historical uses in industrial processes and in products available to consumers and commercial products, respectively.

A 2007 voluntary questionnaire indicated that A. awamori was not in commercial use in 2006; however, 10 000 kg to 100 000 kg of products potentially containing A. brasiliensis were imported into or manufactured in Canada in 2006–2007 for use in products available to consumers and commercial products. The Department of the Environment and the Department of Health (the Departments) issued mandatory surveys under section 71 of CEPAfootnote 2 that included A. awamori and A. brasiliensis. Information received from industry for 2008 and 2016 indicated that these living organisms are not being used in industrial, commercial or consumer activities. While the mandatory surveys revealed that A. brasiliensis was used in very small quantities for academic research, teaching, and research and development activities in 2008, no use of this living organism was reported for 2016. Based on these survey results, the overall environmental and human exposure to these living organisms is estimated to be low.

A. awamori and A. brasiliensis have properties that make them of commercial interest in a wide array of potential applications, including food processing, production of fermentation extract, biochemical and enzyme production, bioremediation and biodegradation, bioleaching, textile processing, municipal and industrial wastewater treatment and as a probiotic in broiler chickens. These are applications of organisms that are closely related to A. awamori and A. brasiliensis, and represent possible uses of strain ATCC 22342 and ATCC 9642 since they are likely to share characteristics (modes of action). Although not reported in Canada, potential future uses of these living organisms could result in their release into the environment through application to soils and direct or indirect input into waterways. Potential future uses could also increase human exposure through direct contact with new products containing these living organisms, or indirectly through releases into the environment.

Summary of the screening assessment

In August 2019, the Ministers published a screening assessment of A. awamori and A. brasiliensis (PDF) on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether either of the living organisms meets one or more of the criteria set out in section 64 of CEPA (i.e. to determine if the living organisms could pose a risk to the environment or human health).

Under section 64 of CEPA, a living organism is considered toxic if it is entering or may enter the environment in a quantity, concentration, or under conditions that

The Departments collected and considered information from multiple sources (e.g. literature reviews, database searches, modelling, and data from mandatory surveys issued under section 71 of CEPA) to inform the screening assessment conclusion that A. awamori and A. brasiliensis do not meet any of the criteria set out in section 64 of CEPA. The assessment also determined that A. awamori and A. brasiliensis have properties of concern that could lead to a risk to the environment or human health if exposure levels to either of the living organisms were to increase due to certain new activities.

Summary of the ecological and human health assessments

A. awamori and A. brasiliensis are thought to share hazardous properties with A. niger, which can cause a wide array of infections, including lung, skin, eye, heart and systemic infections. The risk of A. niger infection increases with predisposing factors such as debilitating disease, surgery, the presence of indwelling medical devices and immune deficiency. A. niger also has pathogenic potential in otherwise healthy humans and recent research suggests the same potential in A. brasiliensis. The vast majority of A. niger–related diseases in healthy humans are mild, self-resolving and usually treatable; however, there have been mortalities in individuals with compromised immune systems. Even among healthy individuals, A. niger can cause ear and eye infections, which could irreversibly damage the ears or eyes, resulting in hearing or vision loss. In addition, A. brasiliensis and A. niger are both resistant to fluconazole, an antifungal drug, which could limit treatment options if an infection were to occur. For these reasons, A. awamori and A. brasiliensis are estimated to have a medium potential to cause a human health hazard.

A. awamori is known to produce toxic compounds such as fumonisin and ochratoxin, which adversely affect animals. Although there have been no reports of animal or plant disease specifically attributed to this living organism, related A. niger strains have been reported as plant pathogens and opportunistic animal pathogens causing mycoses (fungal infection), mastitis (inflammation of breast tissue), and aspergillosis (lung infection/disease). Although there have been no reports of animal or plant disease specifically attributed to A. brasiliensis, due to difficulties distinguishing A. brasiliensis and A. niger from other black aspergilli, it is possible that some cases of diseases in plants or animals attributed to A. niger may have been caused by A. brasiliensis. In laboratory testing of A. brasiliensis by the Department, there were no significant adverse effects on red clover, or the invertebrate Folsomia candida. For these reasons, A. awamori and A. brasiliensis are estimated to have a medium and low to medium potential to cause an environmental hazard, respectively.

The screening assessment assumes that both a hazard and an exposure to that hazard is required for there to be a risk. While A. awamori and A. brasiliensis do have hazard potential, environmental and human exposure to these living organisms is not currently expected, therefore the risk associated with current uses is estimated to be low for both the environment and human health.

The SNAc provisions of CEPA

Under CEPA, any person (individual or corporation) is permitted to carry out activities associated with any living organism listed on the DSL without an obligation to notify the Minister of such activities, provided the living organism is not subject to any risk management or other instruments under the Act. However, if the Ministers assess a living organism and available information suggests that certain new activities related to that living organism may pose a risk to the environment or human health, the Minister may apply the SNAc provisions of CEPA to the living organism.footnote 3 These provisions establish a requirement for any person considering undertaking a significant new activityfootnote 4 (in relation to any living organism subject to the SNAc provisions) 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 living organism before the activity is undertaken, and if necessary, implement risk management measures.

Objective

The objective of Order 2021-112-21-01 Amending the Domestic Substances List (the Order) is to contribute to the protection of the environment and human health by applying the SNAc provisions of CEPA to A. awamori and A. brasiliensis. The Order requires that the Minister be notified of any significant new activity involving either of the living organisms so that further assessment of the living organism is conducted and if necessary, risk management measures are implemented before the activity is undertaken.

Description

Pursuant to subsection 112(3) of CEPA, the Order applies subsection 106(3) of CEPA (i.e. the SNAc provisions) to A. awamori and A. brasiliensis.

Applicability

The Order requires any person wishing to engage in a significant new activity in relation to A. awamori or A. brasiliensis 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 import, manufacture, or use of the living organism for the proposed significant new activity.footnote 5 The Ministers will use the information submitted in the SNAN and other available information to conduct further assessment of the living organism in relation to the new activity before the activity is undertaken, and if necessary, implement risk management measures.

Notification requirements

Below is a summary of the notification requirements for A. awamori and A. brasiliensis. For specific details, please see the regulatory text in the Order.

Activities subject to notification requirements

The notification requirements apply to

Activities not subject to notification requirements

The notification requirements do not apply to

Information requirements

Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to A. awamori and A. brasiliensis. For specific details, please see the regulatory text in the Order.

The Order requires the submission of

Regulatory development

Consultation

On August 24, 2019, the Minister published a Notice of Intent (NOI) to apply the SNAc provisions of CEPA to A. awamori and A. brasiliensis in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received during that period.

The Departments also informed the provincial and territorial governments about the Order through the CEPA National Advisory Council (CEPA NAC)footnote 9 via a letter and provided them with an opportunity to comment. No comments were received from CEPA NAC.

Modern treaty obligations and Indigenous engagement and consultation

The assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders amending the DSL do not introduce any new regulatory requirements related to current activity, and therefore, do not result in any impact on modern treaty rights or obligations, nor create any need for specific engagement and consultation with Indigenous Peoples separate from the public comment period that followed publication of the Notice of Intent.

Instrument choice

For any living organism that does not meet any of the criteria set out in section 64 of CEPA, but that has properties of concern for which certain increases in exposure could result in a risk to the environment or human health, several follow-up actions are available to the Ministers. Such actions could include, but are not limited to applying the SNAc provisions of CEPA, conducting biomonitoring (for humans), conducting environmental monitoring (for air, water, sediment, wastewater, soil, or wildlife), issuing voluntary or mandatory surveys under section 71 of CEPA, and conducting consumer product testing.

Among the options for follow-up actions, applying the SNAc provisions of CEPA will be considered when

The screening assessment informed the determination that applying the SNAc provisions of CEPA is the most appropriate follow-up action for A. awamori and A. brasiliensis, since current activities involving these living organisms do not pose a risk to the environment or human health, but the living organisms have properties of concern that could pose a risk if exposure levels were to increase due to certain new activities.

Regulatory analysis

Benefits and costs

The Order contributes to the protection of the environment and human health by requiring that proposed significant new activities involving A. awamori and A. brasiliensis undergo further assessment before the activity is undertaken, and that if necessary, risk management measures are implemented.

The Order does not impose any regulatory requirements (and therefore, any administrative or compliance costs) on businesses related to current activities. The Order would only target significant new activities involving either living organism, should any person choose to pursue such an activity. In the event that any person wishes to use, import, or manufacture A. awamori or A. brasiliensis 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 Departments would incur costs for processing the information and conducting further assessment of the living organism 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 activity.

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 activity.

Regulatory cooperation and alignment

Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g. United States Environmental Protection Agency, European Chemicals Agency, and Organisation of Economic Cooperation and Development) and is party to several international multilateral environmental agreements in the area of chemicals and waste.footnote 11 The CMP is administered in cooperation and alignment with these agreements.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals (PDF), a Strategic Environmental Assessment was completed for the CMP, which includes orders amending the DSL. The assessment concluded that the CMP is expected to have a positive impact on the environment and human health.

Gender-based analysis plus

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

Implementation, compliance and enforcement, and service standards

Implementation

The Order is in force on the day that it is registered. Compliance promotion activities conducted as part of the implementation of the Order will include developing and distributing promotional material, responding to inquiries from stakeholders, and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.

Compliance

When assessing whether or not a living organism is subject to SNAc provisions, 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 living organism, mixture, or product are expected to have access to import records, usage information, and the relevant Safety Data Sheet.footnote 12

If any information becomes available that reasonably supports the conclusion that a living organism subject to SNAc provisions is toxic or capable of becoming toxic under section 64 of CEPA, the person who is in possession of, or who has knowledge of the information and who is involved in activities with the living organism, is obligated under section 70 of CEPA to provide that information to the Minister without delay.

Any person who transfers the physical possession or control of a living organism 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.

In cases where a person receives possession and control of a living organism from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by a SNAN submitted by the supplier on behalf of its clients.

A pre-notification consultation (PNC) is available 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 obligations to comply with an order, believes they may be out of compliance, or would like to request a PNC, they are encouraged to contact the Substances Management Information Line.footnote 13

Enforcement

The Order is made under the authority of CEPA, which is enforced in accordance with the Compliance and Enforcement Policy for the Canadian Environmental Protection Act. In instances of non-compliance, consideration is given to the following factors when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations, and consistency in enforcement. Suspected violations under CEPA can be reported to the Enforcement Branch by email at enviroinfo@ec.gc.ca.

Service standards

In the event that a SNAN is submitted to the Minister in relation to A. awamori or A. brasiliensis, the Ministers will assess the information after the complete information is received, within the prescribed timelines set out in the Order.

Contacts

Thomas Kruidenier
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
Telephone: 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada)
Email: substances@ec.gc.ca

Andrew Beck
Director
Risk Management Bureau
Department of Health
Ottawa, Ontario
K1A 0K9
Telephone: 613‑266‑3591
Email: andrew.beck@hc-sc.gc.ca