Order 2021-112-20-01 Amending the Domestic Substances List: SOR/2021-183
Canada Gazette, Part II, Volume 155, Number 17
SOR/2021-183 August 6, 2021
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the living organism set out in the annexed Order is specified on the Domestic Substances List footnote 1;
Therefore, the Minister of the Environment, pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2021-112-20-01 Amending the Domestic Substances List.
Gatineau, August 4, 2021
Minister of the Environment
Order 2021-112-20-01 Amending the Domestic Substances List
1 Part 5 of the Domestic Substances List footnote 1 is amended by deleting the following under the heading “Organisms/Organismes”:
- Trichoderma reesei
Significant New Activity for which living organism is subject to subsection 106(3) of the Act
ATCC 74252 S′
|1 Any activity that involves Trichoderma reesei, other than
4 The studies referred to in paragraph 3(c) and subparagraph 3(d)(ii) 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 on May 12, 1981 by the Organization for Economic Co-operation and Development (OECD), that are current at the time the study is conducted.
5 The study referred to in subparagraph 3(d)(i) must be conducted in accordance with the Environment and Climate Change Canada report EPS 1/RM/44, entitled Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms, second edition, December 2016.
6 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.)
A strain of the living organism Trichoderma reesei (strain ATCC footnote 2 74252; hereafter referred to as “T. reesei”) has properties of concern that could pose a risk to the environment if exposure levels to the living organism 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 or the Act) to apply the Significant New Activity (SNAc) provisions of CEPA to T. reesei.
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 T. reesei in accordance with section 74 of CEPA as part of the CMP.
Description, uses, and sources of release
T. reesei is a fungus that could have a number of industrial and commercial uses, including the production of proteins and microbial pesticides, as well as waste management.
The Department of the Environment and the Department of Health (the Departments) issued mandatory surveys under section 71 of CEPA footnote 3 that included T. reesei. Information received from industry for the reporting year 2008 indicated that 10 000 to 100 000 kilograms of T. reesei were manufactured in Canada for industrial uses. Reported uses were limited to industrial processes within one contained facility, and direct releases of the living organism into the environment are not expected from these activities.
Although not reported in Canada, potential future uses of T. reesei in bioremediation, biodegradation, or pesticides could result in the release of the living organism to the environment from its application to soils, plants, and seeds. These releases could expose terrestrial plants and invertebrates, and, to a lesser extent, terrestrial vertebrates feeding at the site of application, or aquatic species via runoff from treated plants and soils.
Summary of the screening assessment
In February 2018, the ministers published a screening assessment for T. reesei on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether the living organism meets one or more of the criteria set out in section 64 of CEPA (i.e. to determine if the living organism could pose a risk to the environment or human health).
Under section 64 of CEPA, a substance 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 T. reesei does not meet any of the criteria set out in section 64 of CEPA. The assessment also determined that T. reesei has properties of concern that could lead to a risk to the environment if exposure levels to the living organism were to increase due to certain new activities.
Summary of the ecological and human health assessment
The screening assessment characterized the ecological risks of T. reesei using information from multiple sources, and assessed them to be “low-medium.” T. reesei has not been reported to act as an aquatic or terrestrial plant pathogen, and the living organism can have a positive effect on plant growth and systemic resistance to infection. There are no reports in the literature of adverse effects to aquatic or terrestrial vertebrates, despite its natural presence in tropical soils. Cases of infection in terrestrial vertebrates have only been reported under experimental conditions in immunocompromised animals. T. reesei has not been observed to adversely affect aquatic invertebrates; however, paracelsin, a chemical produced by T. reesei, is toxic to larval and adult brine shrimp, as well as to adult water fleas. The human health risks of T. reesei were characterized using information from multiple sources and assessed to be “low,” based on several considerations, such as the finding that there have been no reported cases in the literature of human infections caused by the living organism.
The screening assessment concluded that current exposure levels to T. reesei do not meet any of the criteria for a toxic substance set out in section 64 of CEPA. It also determined that the living organism could pose a risk to the environment if exposure levels were to increase due to certain new activities. In order to address this concern, the Minister is applying the SNAc provisions of CEPA to T. reesei.
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 4 These provisions establish a requirement for any person considering undertaking a significant new activity (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 will conduct further assessment of the living organism, and, if necessary, implement risk management measures before the activity is undertaken.
The objective of Order 2021-112-20-01 Amending the Domestic Substances List (the Order) is to contribute to the protection of the environment by applying the SNAc provisions of CEPA to T. reesei. The Order requires that the Minister be notified of any significant new activity involving the living organism 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 T. reesei.
The Order requires any person wishing to engage in a significant new activity in relation to T. reesei 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 a significant new activity. footnote 5 The ministers will use the information submitted in the SNAN, and other available information, to conduct further risk assessment of the living organism and, if necessary, implement risk management measures before the activity is undertaken.
Below is a summary of the notification requirements for T. reesei. For specific details, please see the regulatory text in the Order.
Activities subject to notification requirements
The notification requirements apply to
- any activity involving the use of T. reesei, except for the activities not subject to notification requirements (below).
Activities not subject to notification requirements
The notification requirements do not apply to
- the use of the living organism in its submerged fermentation in the absence of light with no solid plant material or insoluble substrate present;
- the use of the living organism's culture in a vessel where it is inactivated (i.e. able to achieve an inactivation rate of 99.9999%) prior to, or upon, removal from the vessel, and all solid and liquid wastes from the living organism are incinerated;
- the use of the living organism as a research and development organism; footnote 6
- 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, or substances carried through Canada). footnote 7
Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to T. reesei. 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, 4, 7 and 9 of Schedule 1 to the New Substances Notification Regulations (Organisms) [SOR/2005-248];
- data and associated report from studies conducted to determine whether substances produced by the living organism in the course of a proposed significant new activity have the potential to be of environmental concern; and
- all other information and test data in respect of the living organism, including additional details surrounding its use, and exposure information.
On February 24, 2018, the Minister published a Notice of Intent (NoI) to apply the SNAc provisions of CEPA to T. reesei in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received during this period.
The Departments informed the provincial and territorial governments about the Order through the CEPA National Advisory Council (CEPA NAC) footnote 8 via a letter, and provided them with an opportunity to comment. No comments were received from the 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 impose 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 a living organism that does not meet 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; issuing voluntary or mandatory surveys under section 71 of CEPA; conducting an inventory update for specified living organisms on the DSL; 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 9
The screening assessment informed the determination that applying the SNAc provisions of CEPA is the most appropriate follow-up action for T. reesei, since current activities involving the living organism do not pose a risk to the environment or human health, but the living organism contains properties of concern that could pose a risk to the environment 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 T. reesei 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 only target significant new activities involving the living organism, should any person choose to pursue such an activity. In the event that any person wishes to use, import, or manufacture T. reesei 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 for Economic Cooperation and Development), and is party to several international multilateral environmental agreements in the area of chemicals and waste. footnote 10 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, a (ARCHIVED) Strategic Environmental Assessment was completed for the CMP, which encompasses 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 Order.
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 11
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 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 them 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. footnote 12
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 T. reesei, 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