Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2020-217
Canada Gazette, Part II, Volume 154, Number 22
SOR/2020-217 October 6, 2020
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2020-769 October 2, 2020
Whereas, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on November 11, 2017, a copy of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;
And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substance set out in the annexed Order is a toxic substance;
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote 1 is amended by adding the following in numerical order:
- 144 Benzene, 1-chloro-2-[2,2-dichloro-1-(4- chlorophenyl)ethyl]-, which has the molecular formula C14H10Cl4
Coming into Force
2 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.)
The substance benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]- (CAS RN footnote 2 53-19-0; hereinafter referred to as “mitotane”) meets the criteria for a toxic substance as set out in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA or the Act) and for virtual elimination as set out in subsection 77(4) of the Act. Mitotane is used in Canada as an essential therapeutic drug. Since mitotane met the criteria aforementioned, the Minister of the Environment and the Minister of Health (the ministers) recommended to the Governor in Council to amend Schedule 1 of the Act to add mitotane to the List of Toxic Substances in accordance with subsection 90(1) of CEPA, but are not considering limiting its essential use as a therapeutic drug in Canada.
The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and micro-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 of mitotane
Mitotane does not occur naturally in the environment. Mitotane has low solubility in water, has minimal volatility, and has a tendency to partition to the particles and lipids of organisms. Mandatory surveys issued under section 71 of CEPA indicated that, for the reporting year 2005, the substance was not manufactured in Canada, though 100 kg to 1 000 kg were imported, while 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. The only known use of mitotane in Canada that was identified and assessed in the screening assessment is as a prescription drug (an oral chemotherapeutic agent) used in the treatment of cancers of the adrenal gland, and is considered by many clinicians as the “drug of choice” for the treatment of these cancers. Mitotane is registered as an ingredient in a licensed pharmaceutical drug in the Department of Health’s Drug Product Database, and direct exposure from this use of the substance is managed under the Food and Drug Regulations. An estimated 93 kg, 100 kg, and 60 kg of mitotane were used as pharmaceuticals in Canada in 2007, 2011, and 2012, respectively. Information received from the pharmaceutical industry in 2013 reported that the use of mitotane as a therapeutic product for the treatment of cancer of the adrenal gland in Canada varies from year to year, but is generally in the range of 100 kg to 1 000 kg per year at a dosage of 2 g to 16 g per patient per day.
Mitotane can enter the Canadian environment through long-range transport (e.g. in air) from other countries. The historic use of the insecticides dichlorodiphenyltrichloroethane (DDT) and dicofol can continue to be a source of low-level releases of mitotane, especially considering that mitotane is a degradation product or metabolite of these insecticides (i.e. an unwanted chemical that can be produced when DDT or dicofol that is still in the environment slowly degrades). Therefore, the presence of mitotane in the Canadian environment can be associated with past applications of DDT and dicofol, as well as its current use as a therapeutic drug. In its current use, mitotane may be released down the drain to water via waste-water treatment systems, and may reside in water, biosolids from wastewater treatment system sludge, and in sediments in proximity to the sources of release. However, there are a limited number of patients using mitotane in Canada at any given time.
Summary of the screening assessment
In October 2017, the ministers published a final screening assessment on 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 for a toxic substance as set out in section 64 of CEPA (i.e. to determine if the substance could pose a risk to the environment or to human health in Canada).
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 Department of the Environment and the Department of Health (the departments) generated and collected information from modelling, literature reviews, database searches, and mandatory surveys issued under section 71 of CEPA to inform the screening assessment conclusion that mitotane meets the ecological criterion for a toxic substance as set out in paragraph 64(a) of CEPA, and thus, constitutes a risk to the environment in Canada.
Summary of the ecological assessment
The ecological assessment found that mitotane has the potential to be highly hazardous to several species of aquatic organisms because it is expected to cause acute and chronic harm at low concentrations. In addition, the assessment concluded that mitotane is expected to be highly persistent in air, water, soil, and sediment, that it has the potential to bioaccumulate in aquatic organisms, and that it may biomagnify in aquatic food chains.
While limited quantities of mitotane are used as pharmaceuticals in Canada, a relatively large proportion of this amount may be released to municipal wastewater systems through excretion. These releases may be concentrated at a small number of sites. The ecological assessment compared estimated levels of mitotane near points of release in lakes and rivers receiving wastewater treatment system effluent with levels expected to cause harm to aquatic organisms and found that there is a potential for ecological harm. Furthermore, there are long-term risks associated with persistent and bioaccumulative substances due to the compounding effects over long periods of time. Therefore, although only small amounts of mitotane may be released based on its use as a therapeutic drug, these releases remain a source of concern for the environment in Canada. These releases add to the total quantity of mitotane currently present in the environment as a result of the historical use of DDT and dicofol. The screening assessment concluded that mitotane meets the criterion for a toxic substance set out in paragraph 64(a) of CEPA, but does not meet the criterion set out in paragraph 64(b).
Summary of the human health assessment
Based on information received from mandatory surveys issued under section 71 of CEPA, there were no reported uses of mitotane in consumer products; therefore, direct exposure to the general population from consumer products containing mitotane is not expected. The only known use of mitotane in Canada that was identified and assessed in the screening assessment is as a licensed pharmaceutical drug for the treatment of adrenal cancer. The potential for direct exposure to the general population from this use is already managed under the Food and Drug Regulations, and any potential new use of mitotane to treat human-related illnesses in Canada will be managed under the Food and Drugs Act. Therefore, exposure to mitotane from its use as a therapeutic drug in Canada is not a human health concern. Given the current control measures and uses of mitotane in Canada, the screening assessment determined that mitotane did not meet the human health criterion for a toxic substance under paragraph 64(c) of CEPA.
Consideration of virtual elimination as a risk management measure for mitotane
Virtual elimination is defined in subsection 65(1) of CEPA as the reduction of the quantity or concentration of a toxic substance, in the release, to below a certain level specified by the ministers (i.e. the lowest levels of the substance that can be accurately measured using sensitive but routine sampling and analytical methods). footnote 3 In accordance with subsection 77(4) of CEPA, the implementation of virtual elimination is applicable if
- the substance met one of the criteria for a toxic substance as set out in section 64 of CEPA;
- the substance was found to be persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations;
- the presence of the substance in the environment resulted primarily from human activity; and
- the substance was not a naturally occurring inorganic substance or radionuclide.
The implementation of virtual elimination applies to mitotane. However, in accordance with subsection 65(3) of CEPA, the ministers must take into account factors such as stakeholder comments, environmental risks, health risks, and other relevant social, economic, or technical matters when determining what preventative or control measures to take in relation to a substance. The only known use of mitotane in Canada that was identified and assessed in the screening assessment is as a therapeutic drug. Given the importance of this use of mitotane in Canada, and since direct exposure from this use is risk-managed under the Food and Drug Regulations and potential releases into the environment would be limited given the small number of patients using mitotane at any given time, the ministers are not limiting its essential use as a therapeutic drug in Canada. This decision does not preclude the ministers from implementing 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 objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to add mitotane to the List of Toxic Substances in Schedule 1 of CEPA, which would enable the ministers to propose risk management measures for a toxic substance under CEPA to manage potential environmental risks associated with mitotane, should such measures be deemed necessary in the future.
The Order adds benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]- (mitotane) to the List of Toxic Substances in Schedule 1 of CEPA.
On July 6, 2013, the ministers published a summary of the draft screening assessment for mitotane in the Canada Gazette, Part I, for a 60-day public comment period. On the same date, the risk management scope document for mitotane was published on the Canada.ca (Chemical Substances) website. During this period, no comments were received on the draft screening assessment report, and one comment was received on the risk management scope document. footnote 4 The comment highlighted the medical necessity of mitotane as the “treatment of choice” for adrenal cancers in Canada, and indicated that, while the quantity of mitotane required by patients varies, importation of the substance into Canada usually ranges from 100 kg to 1 000 kg per year. The departments integrated this data on use quantities into the final screening assessment and, in the Summary of Public Comments table published at the same time as the final screening assessment, referred the commenter to the Risk Management Approach for mitotane, which confirmed that no risk management actions are being proposed to limit the use of mitotane as a therapeutic drug.
On October 28, 2017, the final screening assessment report and the risk management approach for mitotane were published on the Canada.ca (Chemical Substances) website, and on November 11, 2017, the proposed Order recommending the addition of mitotane to Schedule 1 of CEPA was published 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 all publications through the CEPA National Advisory Committee (CEPA NAC) footnote 5 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 made in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders adding substances to the List of Toxic Substances in Schedule 1 of CEPA do not impose any regulatory or administrative burdens and therefore do not result in any impact on modern treaty rights or obligations. The assessment also concluded that the making of an order under section 90 of the Act does not require specific engagement and consultation with Indigenous peoples.
When a substance meets one or more of the criteria for a toxic substance as set out in section 64 of CEPA, the ministers shall propose one of the following measures under subsection 77(2) of the Act:
- (a) taking no further action with respect to the substance;
- (b) unless the substance is already on the Priority Substances List, adding the substance to the Priority Substances List for further assessment; or
- (c) recommending that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA, and, where applicable, recommending the implementation of virtual elimination under subsection 65(3) of CEPA.
Based on the conclusions of the screening assessment, the ministers determined that choosing options in paragraphs 77(2)(a) or (b) of the Act (i.e. taking no further action, or adding the substances to the Priority Substances List) is not appropriate to manage potential ecological risks associated with mitotane in Canada. Since the substance meets the criteria for virtual elimination set out in subsection 77(4) of CEPA, it is mandatory that mitotane be added to the List of Toxic Substances in Schedule 1 of CEPA. However, given the essential use of mitotane as a therapeutic drug in Canada, the ministers decided that no control measures for a toxic substance under CEPA that would limit the use of mitotane in this capacity would be considered following its addition to Schedule 1. Therefore, the ministers recommended to the Governor in Council to make an order to add mitotane to the List of Toxic Substances in Schedule 1 of CEPA. An order is the only available instrument to implement this recommendation.
Benefits and costs
The addition of mitotane to the List of Toxic substances in Schedule 1 of CEPA has no impacts (benefits or costs). The Order is required to address the screening assessment conclusion for mitotane, which determined that the substance meets the ecological criterion for a toxic substance as set out in paragraph 64(a) of CEPA. The Order will not result in any compliance requirements for stakeholders. The Order enables the ministers to propose risk management measures for a toxic substance under CEPA to manage potential ecological risks associated with mitotane, should such measures be deemed necessary in the future. In the event that control measures are deemed necessary, the benefits and costs of such measures would be assessed and consultation would be held with the public and other interested parties during the development of that proposal.
Small business lens
The assessment of the small business lens concluded that the Order does not have an impact on small businesses, as it does not impose any new administrative or compliance costs on businesses.
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.
Regulatory cooperation and alignment
Canada is engaged in several international bilateral and multilateral agreements related to chemicals and their management, footnote 6 and the CMP is administered in cooperation and alignment with these agreements.
According to the United States Food and Drug Administration, mitotane is used in the United States as a therapeutic drug for treating cancers of the adrenal gland as well as Cushing’s syndrome. The departments are not aware of any international risk management measures in place for controlling releases of mitotane into the environment from its use as a therapeutic drug.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment (archived) was completed for the CMP, which encompasses orders adding substances to the List of Toxic Substances in Schedule 1 of CEPA. The assessment concluded that the CMP is expected to have a positive effect on the environment and human health.
Gender-based analysis plus
The gender-based analysis plus (GBA+) assessment concluded that the Order does not affect socio-demographic groups based on factors such as gender, sex, age, language, education, geography, culture, ethnicity, income, ability, sexual orientation or gender identity.
Implementation, compliance and enforcement, and service standards
As no specific risk management measures are recommended as part of the Order, developing an implementation plan and a compliance and enforcement strategy, as well as establishing service standards, is not necessary. A complete assessment of these elements would be undertaken during the development of any proposed risk management measures for mitotane, should such measures be deemed necessary in the future.
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Department of the Environment
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