Order 2021-112-21-01 Amending the Domestic Substances List: SOR/2022-137
Canada Gazette, Part II, Volume 156, Number 13
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
Minister of the Environment
Order 2021-112-21-01 Amending the Domestic Substances List
1 Part 5 of the Domestic Substances List footnote a is amended by deleting the following under the heading “Organisms/Organismes”:
Significant New Activity for which living organism is subject to subsection 106(3) of the Act
ATCC 22342 S′
ATCC 9642 S’
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.)
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
- Aspergillus awamori strain ATCCfootnote 1 22342 (also Aspergillus niger ATCC 22342, hereafter referred to as “A. awamori”); and
- Aspergillus brasiliensis strain ATCC 9642 (hereafter referred to as “A. brasiliensis”).
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
- (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- (b) constitute or may constitute a danger to the environment on which life depends; or
- (c) constitute or may constitute a danger in Canada to human life or health.
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.
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.
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.
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.
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
- any consumer product to which the Canada Consumer Product Safety Act applies; and
- any use of the living organism 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).
Activities not subject to notification requirements
The notification requirements do not apply to
- any use of the living organism as a research and development organismfootnote 6 in a contained facilityfootnote 7 that meets the requirements for containment level one at a minimum, and where good microbiological laboratory practices are implemented, as no exposure of concern to the general population is expected under these conditions;
- any use of the living organism that is regulated under the acts of Parliament listed in Schedule 4 of CEPA, including the Pest Control Products Act, the Seeds Act, the Fertilizers Act, the Feeds Act, and the Health of Animals Act; and
- any use of the living organism that is exempt or excluded from notification requirements under CEPA (i.e. as an impurity or contaminant related to the preparation of the living organism, and, under certain circumstances, in mixtures, manufactured items, living organisms carried through Canada).footnote 8
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
- a description of the proposed significant new activity;
- relevant information in sections 1, 2, 3, and 6 of Schedule 1 to the New Substances Notification Regulations (Organisms) [SOR/2005-248]; and
- all other information in respect of the living organism including additional details surrounding use and exposure information.
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.
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
- there are no or limited uses of the living organism in Canada, but there is a suspicion that a significant new activity could pose risk;
- the current uses of the living organism in Canada present no or limited risk, but there is a suspicion that a significant new activity could pose risk; or
- the current uses of the living organism in Canada are adequately managed, but there is a suspicion that a significant new activity could pose risk.footnote 10
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.
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.
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
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.
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
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 firstname.lastname@example.org.
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.
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
Telephone: 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada)
Risk Management Bureau
Department of Health