Order 2021-87-21-01 Amending the Domestic Substances List: SOR/2021-172
Canada Gazette, Part II, Volume 155, Number 15
Registration
SOR/2021-172 July 5, 2021
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the substance set out in the annexed Order is specified on the Domestic Substances List footnote 1;
Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of the substance under section 74 of the Canadian Environmental Protection Act, 1999 footnote a;
And whereas the Minister of the Environment and the Minister of Health suspect that the information concerning a significant new activity in relation to the substance set out in the annexed Order may contribute to determining the circumstances in which the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 footnote a.
Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999footnote a, makes the annexed Order 2021-87-21-01 Amending the Domestic Substances List.
Gatineau, June 28, 2021
Jonathan Wilkinson
Minister of the Environment
Order 2021-87-21-01 Amending the Domestic Substances List
Amendments
1 Part 1 of the Domestic Substances List footnote 1 is amended by deleting the following:
53-19-0
| Column 1 Substance |
Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act |
|---|---|
| 53-19-0 S′ | 1 Any activity involving the use of the substance benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-, other than its use
2 For each proposed significant new activity involving the use of the substance as a laboratory analytical standard in a quantity greater than 10 grams per year, as a research and development substance, as defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers) in a quantity greater than 10 grams per year or as a site-limited intermediate substance, as defined in subsection 1(1) of those Regulations, the following information must be provided to the Minister at least 180 days before the day on which the significant new activity begins:
3 For any other proposed significant new activity the following information, in addition to the information set out in section 2, must be provided to the Minister at least 180 days before the day on which the significant new activity begins:
4 The information referred to in sections 2 and 3 is to be assessed within 180 days after the day on which it is received by the Minister. |
Coming into Force
3 This Order comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
Issues
The substance benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]- (CAS RN footnote 2 53-19-0; hereafter referred to as “mitotane”) meets the ecological criterion for a toxic substance as set out in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA or the Act). While the Minister of the Environment and the Minister of Health (the ministers) are not limiting the essential use of mitotane as a therapeutic product in Canada, the substance has properties of concern that pose a risk to the environment and that would result in a greater risk to the environment if new activities involving mitotane were undertaken. In order to address this concern, the Minister of the Environment (the Minister) is amending the Domestic Substances List (DSL) in accordance with subsection 87(3) of the Act to apply the significant new activity (SNAc) provisions of CEPA to mitotane.
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 ministers assessed mitotane in accordance with section 74 of CEPA as part of the CMP.
Description, uses, and sources of release
Mitotane does not occur naturally in the environment. Mitotane has low solubility in water, has minimal volatility, and has a tendency to attach or absorb to particles and lipids within organisms. The Department of the Environment and the Department of Health (the departments) issued mandatory surveys under section 71 of CEPA footnote 3 that included mitotane for the reporting years 2005 and 2006. Information received from industry indicated that, for the reporting year 2005, the substance was not manufactured in Canada, though 100 kg to 1 000 kg were imported, and, for the reporting year 2006, mitotane was not reported to be imported into Canada above the reporting threshold of 100 kg, nor used above the reporting threshold of 1 000 kg.
The section 71 surveys indicated no reports for the use of mitotane in consumer products in Canada. During the development of the screening assessment for mitotane, the departments identified the use of the substance as a prescription drug (specifically, an oral chemotherapeutic agent) for the treatment of certain cancers. This substance is considered by many clinicians as the “drug of choice” to treat cancers of the adrenal gland. In addition, public comments received from a pharmaceutical company identified the use of mitotane as an analytical standard (a compound of high purity and known concentration used as a calibration standard to measure the presence, amount, or functional activity of a target entity). The Department of Health also identified an off-label use of mitotane in the treatment of Cushing’s syndrome in humans and dogs.
Historically, mitotane was released into the environment through use of the insecticides dichlorodiphenyltrichloroethane (DDT) and dicofol, both of which have been phased out of Canadian commerce. These historic uses continue to release low levels of mitotane into the environment as the DDT and DDT contaminant in dicofol that persist in environmental media slowly degrade. Mitotane can also enter the environment through long-range transport (e.g. in air) from other countries’ use of DDT and dicofol. In addition to these low and continuous (but decreasing) releases over time, the limited amount of mitotane that is currently being used in therapeutic drugs may be released (primarily through patient excretion) down the drain to water via wastewater treatment systems. Once released, this mitotane may reside in water, biosolids from wastewater treatment system sludge, and sediments in proximity to the sources of release.
Summary of the screening assessment
In October 2017, the ministers published a screening assessment for mitotane on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether the substance meets one or more of the criteria set out in section 64 of CEPA (i.e. to determine if the substance 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 or 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, internal and external database searches, modelling, data from mandatory surveys issued under section 71 of CEPA, and, where warranted, data from targeted follow-ups with stakeholders) to inform the screening assessment conclusion. The ecological portions of the assessment underwent external peer review and consultation. The screening assessment concluded that mitotane meets the ecological criterion for a toxic substance set out in paragraph 64(a) of CEPA and thus constitutes a risk to the environment. Below are summaries of the ecological and human health assessments.
Summary of the ecological and human health assessments
The ecological assessment found that mitotane is expected to be persistent in air, water, soil, and sediments; to have the potential to bioaccumulate in aquatic organisms; and to biomagnify in certain freshwater food chains. Mitotane also has the potential to be highly hazardous to aquatic organisms, as it is expected to cause acute and chronic harm at low concentrations. To further assist in determining whether releases of mitotane to the environment from its current use as a prescription cancer drug (primarily through patient excretion) constitutes an ecological risk, the departments calculated the ratio between predicted environmental concentrations (PECs) and predicted no-effect concentrations (PNECs). If the PEC value for any given exposure scenario exceeds the PNEC value, there is a potential for ecological harm from that exposure scenario. The departments estimated PECs for 1 000 wastewater treatment system discharge points across Canada assuming a known quantity of mitotane used nationally per year and an estimated range in the total number of patients. The analysis indicated that the PECs for mitotane may exceed the PNEC near the point of wastewater discharge at 25 to 250 sites (approximately 2.5 to 25% of total wastewater discharge sites) annually. These releases, while limited, add to the total quantity of mitotane currently present in the environment resulting from the historical use of DDT and dicofol. The screening assessment determined that mitotane meets the ecological criterion for a toxic substance as set out in paragraph 64(a) of CEPA, as well as the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.
The human health assessment found that direct general population exposure to mitotane is not expected, since the substance was not reported to be used in consumer products. Exposure to mitotane from its use as a prescription drug does not constitute a human health concern, as this use is already risk managed under the Food and Drug Regulations, and any potential new use of mitotane to treat human-related illnesses would be managed under the Food and Drugs Act. Given the state of current control measures, the screening assessment determined that mitotane does not meet the human health criterion for a toxic substance as set out in paragraph 64(c) of CEPA.
Addition to Schedule 1 to CEPA and subsequent risk management
On October 28, 2020, the ministers published the order adding mitotane to Schedule 1 to CEPA (the List of Toxic Substances) in the Canada Gazette, Part II. Notwithstanding the fact that mitotane meets the criteria footnote 4 for virtual elimination, footnote 5 the ministers must take into account additional factors (in accordance with subsection 65(3) of CEPA) when proposing risk management measures, such as stakeholder comments, environmental and health risks, and other relevant social, economic, or technical matters. Given the importance of the use of mitotane in Canada as a therapeutic product, that direct exposure from this essential use is risk managed under the Food and Drug Regulations, and that potential releases to the environment are limited (since only a small number of patients use mitotane in this way at the same time), the ministers are not proposing any risk management measures that would limit the essential use of mitotane as a therapeutic product in Canada.
In order to address the potential environmental and human health concerns from new activities involving mitotane, the Minister is applying the SNAc provisions of CEPA to the substance. This decision does not preclude the ministers from proposing other risk management measures for a toxic substance under CEPA on mitotane in the future, should such measures be deemed necessary due to new activities that were not identified and assessed in the screening assessment.
The SNAc provisions of CEPA
Under CEPA, any person (individual or corporation) is permitted to carry out activities associated with any substance listed on the DSL without an obligation to notify the Minister of such activities, provided the substance is not subject to any risk management or other instruments under the Act. However, if the ministers assess a substance and available information suggests that new activities related to that substance may pose a risk to the environment or human health, the Minister may apply the SNAc provisions of CEPA to the substance. footnote 6 These provisions establish a requirement for any person (individual or corporation) considering undertaking a significant new activity (in relation to any substance subject to the 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 substance, and, if necessary, implement risk management measures before the activity is undertaken.
Objective
The objective of Order 2021-87-21-01 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 mitotane. The Order requires that the Minister be notified of any significant new activity involving the substance, and presented with the required information, so that further assessment of the substance is conducted before the activity is undertaken in Canada, and, if necessary, risk management measures are implemented.
Description
Pursuant to subsection 87(3) of CEPA, the Order applies subsection 81(3) CEPA (i.e. the SNAc provisions) to mitotane.
Applicability
The Order requires any person (individual or corporation) wishing to engage in a significant new activity in relation to mitotane 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 180 days prior to the import, manufacture, or use of the substance for the proposed significant new activity. footnote 7 The ministers will use the information submitted in the SNAN and other available information to conduct further assessment of the substance, and, if necessary, implement risk management measures before the activity is undertaken.
Notification requirements
Below is a summary of the new notification requirements for mitotane. 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 mitotane, except for the activities not subject to notification requirements (below).
Activities not subject to notification requirements
The notification requirements do not apply to
- use of the substance in a therapeutic product that is the subject of a submission to the Department of Health to be authorized for use in Canada, or use of the substance in a therapeutic product authorized for use in Canada, including for use in a clinical trial;
- use of the substance as an analytical standard in a laboratory setting at a quantity of less than or equal to 10 g per year;
- use of the substance as a research and development substance footnote 8 at a quantity of less than or equal to 10 g per year;
- any use of the substance that is regulated under the Acts of Parliament listed in Schedule 2 to CEPA, including the Pest Control Products Act, the Fertilizers Act, and the Feeds Act; and
- any use of the substance that is exempt or excluded from notification requirements under CEPA (i.e. as a transient reaction intermediate, impurity, contaminant, partially unreacted material, or incidental reaction product, and, under certain circumstances, in mixtures, manufactured items, wastes, or substances carried through Canada). footnote 9
Information requirements
Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to mitotane. For specific details, please see the regulatory text in the Order.
For any significant new activity that uses mitotane as a site-limited intermediate substance footnote 8 (at any quantity), or as a laboratory analytical standard or a research and development substance (at a quantity of greater than 10 g per year), the Order requires the submission of
- a description of the proposed significant new activity;
- a description of the product that contains the substance, the intended use of that product, and the function of the substance within that product;
- relevant information in schedules 5 and 6 to the New Substances Notification Regulations (Chemicals and Polymers) [SOR/2005-247]; and
- other information in respect of the substance, including additional details surrounding use, and exposure information.
For any other significant new activity involving mitotane, in addition to the requirements above, the Order requires the submission of
- additional relevant information in schedules 4 and 5 to the New Substances Notification Regulations (Chemicals and Polymers) [SOR/2005-247];
- a description of how the substance will be dispersed, contained, or consumed;
- a description of the method for treating and/or disposing of waste associated with the substance; and
- other information in respect of the substance.
Regulatory development
Consultation
Alongside the publication of the final screening assessment for mitotane on October 28, 2017, the ministers published a risk management approach document on the Canada.ca (chemical substances) website, which outlined the proposal to apply the SNAc provisions of CEPA to mitotane following its addition to Schedule 1 to CEPA. On February 1, 2020, the Minister published a notice of intent to apply the SNAc provisions of CEPA to mitotane in the Canada Gazette, Part I, for a 60-day public comment period. The Department received three comments during this period.
One public comment from a private citizen provided information pertaining to the final screening assessment, to which department officials responded by explaining aspects of the assessment and risk management approach via email correspondence. One industry member sought clarification on the process of the SNAc provisions, to which department officials provided such clarifications via email correspondence. Another industry member provided new information concerning an existing use of mitotane as an analytical standard in laboratory settings. Based on the information submitted by that stakeholder, and other available information, the Department determined that individual Canadian companies are importing mitotane for use as a laboratory analytical standard in quantities of less than 10 g per year. As a result of this determination, the Department changed the notification threshold in the Order pertaining to the use of mitotane as an analytical standard from (de facto) 0 g per year to 10 g per year.
For consistency with the Prohibition of Certain Toxic Substances Regulations, 2012, the SNAc requirements outlined in the notice of intent were adjusted in the Order to exclude the use of mitotane as a research and development substance at a quantity of less than 10 g per year.
The departments also informed the provincial and territorial governments about the Order through the CEPA National Advisory Committee (CEPA NAC) footnote 10 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
An 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 follows publication of the notice of intent.
Instrument choice
For any substance that is assessed under section 74 of CEPA and subsequently added to Schedule 1 to CEPA, a regulation or instrument respecting preventive or control actions must be proposed within 24 months from the date of the recommendation to add the substance to Schedule 1, and must be finalized 18 months from the date on which the instrument is proposed, as outlined in sections 91 and 92 of CEPA. The ministers are not proposing any risk management instrument that would limit the essential use of mitotane as a therapeutic product, which is regulated under the Food and Drug Regulations. However, given the hazardous properties associated with mitotane due to its high toxicity to aquatic organisms, significant new activities associated with its use may pose a heightened risk to the environment.
The ministers considered proposing regulations to prohibit or limit the conditions under which mitotane may be imported, manufactured, or used as a potential risk management measure. However, the ministers determined that applying the SNAc provisions of CEPA is the most appropriate risk management instrument for mitotane rather than a regulation under CEPA, because, for the foreseeable future, a national phase out of mitotane is not planned due to its essential use as a therapeutic product. Additionally, the SNAc provisions are more flexible than regulations, as they allow for notification, followed by assessment, of any significant new activity using mitotane. New activities could then be risk managed with a separate risk management instrument, if needed.
Ultimately, the Order does not limit or impede patient access to mitotane as a therapeutic product while requiring that the Minister be notified of new activities involving mitotane that could pose a risk to the environment or human health.
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 mitotane undergo further assessment, and that, if necessary, risk management measures be 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 mitotane, should any person (individual or corporation) choose to pursue such an activity. In the event that any person (individual or corporation) wishes to use, import, or manufacture mitotane 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 substance to which the SNAN relates. The Department of the Environment will incur negligible costs for conducting compliance promotion and enforcement activities associated with the Order.
Small business lens
The assessment of the small business lens concluded that the Order has no impact on small businesses, as it does not impose any administrative or compliance costs on businesses related to current 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. the United States Environmental Protection Agency, the European Chemicals Agency, and the Organization 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, a (ARCHIVED) strategic environmental assessment was completed for the CMP, inclusive of 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 comes into force on the day on which 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 substance is subject to SNAc provisions, a person (individual or corporation) is expected to make use of information in their possession, or to which they may reasonably be expected to have access. This means information in any of the notifier’s offices worldwide, or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, 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 substance subject to SNAc provisions is toxic or capable of becoming toxic under section 64 of CEPA, the person (individual or corporation) who is in possession of, or who has knowledge of the information, and who is involved in activities with the substance, is obligated under section 70 of CEPA to provide that information to the Minister without delay.
Any person (individual or corporation) who transfers the physical possession or control of a substance 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 substance 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 (individual or corporation) has questions concerning their obligation 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, 1999. In instances of non-compliance, consideration is given to the following factors when deciding which enforcement measure to take: the nature of the alleged violation, the effectiveness in achieving compliance with CEPA and its regulations, and the 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 mitotane, 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
Christina Paradiso
Executive Director
Chemicals Management Division
Department of the Environment
Gatineau, Quebec
J8Y 3Z5
Email: christina.paradiso@ec.gc.ca
Andrew Beck
Director
Risk Management Bureau
Department of Health
Ottawa, Ontario
K1A 0K9
Email: andrew.beck@canada.ca