Order 2021-112-20-01 Amending the Domestic Substances List: SOR/2021-183

Canada Gazette, Part II, Volume 155, Number 17

Registration
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

Jonathan Wilkinson
Minister of the Environment

Order 2021-112-20-01 Amending the Domestic Substances List

Amendments

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

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

Trichoderma reesei
ATCC 74252 S′
1 Any activity that involves Trichoderma reesei, other than
  • (a) its submerged fermentation in the absence of light with no solid plant material or insoluble substrate present; or
  • (b) its culture in a vessel, if it is inactivated to achieve an inactivation rate of 99.9999% prior to or on removal from the vessel and all solid and liquid wastes from the living organism are incinerated.
2 Section 1 does not include the following activities:
  • (a) if Trichoderma reesei is loaded on a carrier outside of Canada, moving it through Canada to a location outside Canada, whether or not there is a change of carrier during transit; and
  • (b) the use of Trichoderma reesei 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 a contained facility and the conditions set out in paragraphs 2(3)(a) and (b) 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 paragraphs 2.1(1)(a) to (e) 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 activity begins:
  • (a) a description of the significant new activity;
  • (b) the information specified in paragraphs 1(a) to (g), sections 2 and 3, paragraphs 4(a) and 4(c) and sections 7 and 9 of Schedule 1 to the New Substances Notification Regulations (Organisms);
  • (c) the data and report from a study that is conducted to determine the identity and quantity of peptaibols that are produced by the living organism and present in liquid culture medium in the course of the significant new activity;
  • (d) if an aquatic or terrestrial invertebrate species is likely to be exposed to the living organism in the course of the significant new activity and the data and report referred to in paragraph (c) show that peptaibols are produced by the living organism and present in liquid culture medium,
    • (i) the data and report from a study, conducted under conditions in which the living organism produces peptaibols, to determine the effects of the living organism on those aquatic and terrestrial invertebrate species, and
    • (ii) the data and report from a study conducted to determine the effects of peptaibols produced by the living organism on those aquatic and terrestrial invertebrate species;
  • (e) all other information or data in respect of the living organism and its secondary metabolites that are in the possession of the person who is proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the hazards that the living organism and its secondary metabolites present to the environment and human health and the degree of environmental and public exposure to the living organism and its secondary metabolites;
  • (f) 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;
  • (g) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person 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;
  • (h) 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 or a report that is provided under this section; and
  • (i) a certification 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 who is authorized to act on their behalf.

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.)

Issues

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.

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 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

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.

Objective

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.

Description

Pursuant to subsection 112(3) of CEPA, the Order applies subsection 106(3) of CEPA (i.e. the SNAc provisions) to T. reesei.

Applicability

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.

Notification requirements

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

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 T. reesei. For specific details, please see the regulatory text in the Order.

The Order requires the submission of

Regulatory development

Consultation

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.

Instrument choice

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

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.

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 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.

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 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

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 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

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 ec.enviroinfo.ec@canada.ca.

Service standards

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.

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
Phone: 613‑948‑2585
Email: andrew.beck@canada.ca