Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2021-89

Canada Gazette, Part II, Volume 155, Number 10

Registration
SOR/2021-89 May 1, 2021

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2021-356 April 30, 2021

Whereas, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote 1, the Minister of the Environment published in the Canada Gazette, Part I, on February 17, 2018, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, 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 Administrator in Council is satisfied that the substances set out in the annexed Order are toxic substances;

Therefore, His Excellency the Administrator of the Government of Canada 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 1, makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.

Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999

Amendment

1 Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote 1 is amended by adding the following in numerical order:

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.)

Issues

The Department of the Environment and the Department of Health (the Departments) found, as a result of their screening assessment on selenium and its compounds, that under the Canadian Environmental Protection Act, 1999 (PDF) [CEPA or the Act], selenium and its compounds meet the ecological and human health criteria as set out in paragraphs 64(a) and 64(c) of CEPA, respectively. As a result, under subsection 90(1) of the Act, the Minister of the Environment and the Minister of Health (the ministers) recommended to the Administrator in Council (AiC) to make the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 to add selenium and its compounds to the List of Toxic Substances in Schedule 1 of CEPA.

Background

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 selenium and its compounds in accordance with sections 68 and 74 of CEPA as part of the CMP.

Substances description, uses and sources of release

Selenium is a naturally occurring element. Selenium can be released to the environment from volcanic activity, wildfire, weathering of selenium-rich soils and rocks, sea-salt spray, and volatilization from plants and waterbodies. The substance can also be released to the environment due to human activity. These activities include selenium production; the manufacture, import and use of selenium or selenium-containing substances; and the disposal and waste management of selenium-containing compounds. From these activities, the main sources of concern include mining, the burning of fossil fuels, metal refining operations, agricultural activities, and wastewater treatment. Data from the National Pollutant Release Inventory shows that from 2010 to 2014, on average, about 26 000 kilograms (kg) of selenium were released to water and 16 000 kg of selenium were released to air annually. The reported releases to land are typically less than 100 kg annually.

Selenium is an essential nutrient to human health and for many organisms in the environment. All Canadians are exposed to selenium through their diet, as it is naturally occurring in certain foods. However, there are potential risks to certain sub-populations that have elevated selenium exposure levels. Selenium is also used in a wide variety of products, including certain supplemental foods, natural health products, animal feed, soil supplements, drugs, pest control products, lubricants, metallurgical applications, rubber manufacture, electronic and electrical equipment, and surface coatings of toys. footnote 2 Data collected at the time of assessment indicated that selenium production in Canada fluctuated between 97 000 kg and 191 000 kg annually, between 2005 and 2012. More recent data show production levels of 176 000 kg in 2016.

Although there are sources of selenium and its compounds released to the environment identified in the screening assessment that may pose an ecological and human health risk in Canada, there are also risk management activities that currently manage the use of selenium in products available to consumers and releases to the environment from certain industrial activities.

Canadian risk management activities

The ministers have implemented risk management actions for certain industries to mitigate the risk that selenium and its compounds may pose to the environment and/or human health from elevated exposure. The addition of selenium to certain foods, such as infant formula, formulated liquid diets, and in meal replacements and nutritional supplements is regulated under the Canadian Food and Drug Regulations under the Food and Drugs Act. The use of selenium in natural health products (e.g. multivitamin/mineral supplements for adults) is regulated under the Natural Health Products Regulations. In addition, selenium is regulated under the Pest Control Products Act, the Canada Consumer Product Safety Act, and with the exception of selenium sulfide, selenium and its compounds are included on the List of Prohibited and Restricted Cosmetic Ingredients. The use of selenium in feeds, soil supplements, and fertilizers is regulated under the Fertilizers Act and the Feeds Regulations, 1983. Canada also has guidelines recommending a maximum acceptable concentration for selenium in drinking water.

In Canada, the Metal and Diamond Mining Effluent Regulations, under the Fisheries Act, require metal mines to undertake environmental effects monitoring studies with regard to selenium from their effluents. In addition, selenium releases at uranium mines and mills are controlled through the Uranium Mines and Mills Regulations under the Nuclear Safety and Control Act, which are managed by the Canadian Nuclear Safety Commission. All existing and proposed uranium mines and mills must include selenium in their environmental protection program. Furthermore, a regulation under the Fisheries Act targeting effluent from the coal-mining sector will limit releases of selenium to water.

Under the performance agreements concerning air pollutants from base metals facilities, signatory companies agreed to achieve an annual emission intensity for particulate matter, which contains most metals and metalloids emitted to air, and strive for continual improvements in reducing emissions of individual metals including, for some facilities, selenium. Facilities are also required to consider the Environmental Code of Practice for Base Metals Smelters and Refineries. It recommends facilities take into account ambient air quality objectives and the Canadian Council of Ministers of the Environment ambient water quality guidelines for selenium, achieve the release concentrations for total particulate matter emissions to air, and develop emissions reduction targets for metals of concern. The Reduction of Carbon Dioxide Emissions from Coal-fired Generation of Electricity Regulations are expected to generate co-benefits in reducing volatile and particulate forms of selenium from coal combustion. Finally, the Wastewater Systems Effluent Regulations, under the Fisheries Act, include mandatory minimum effluent quality standards that can be achieved through secondary wastewater treatment. These quality standards are expected to result in the co-benefit of the removal of selenium to varying degrees. footnote 3

Summary of the screening assessment

A screening assessment was conducted to determine if selenium and its compounds meet one or more of the criteria for a toxic substance as set out in section 64 of CEPA. Specifically, this involves determining whether selenium and its compounds are entering or may enter the environment in a quantity or concentration or under conditions that

The assessment of selenium and its compounds considered the combined exposure to all selenium compounds from natural or anthropogenic sources, whether they are present in water, sediment, soil, air, food, or products available to consumers. The screening assessment concluded that selenium and its compounds meet the criteria for a toxic substance set out in paragraphs 64(a) and 64(c) but not 64(b) of CEPA. Below are summaries of the ecological and human health assessments.

Ecological assessment

Selenium is an essential micronutrient taken up by aquatic, soil and sediment-dwelling organisms, through diet and direct contact with the environment. Selenium bioavailability varies widely with environmental conditions, especially in aquatic ecosystems. Selenium is known to be bioaccumulative, and its effect on aquatic organisms can be related to their internal body concentrations. Tissue residues in fish, which are the most sensitive class of aquatic organisms, were used to characterize the exposures that may lead to harm in aquatic ecosystems.

The most severe effect resulting from long-term exposure to elevated concentrations of selenium in the food web is reproductive failure in egg-laying vertebrates (fish, water birds and amphibians). Selenium may accumulate in fish eggs and affect developing embryos and larvae, while adults appear to be less affected. Reduced egg hatchability and increased embryonic deformities are the main selenium toxicity endpoints observed in birds, although causal evidence is sparse for oviparous reptiles and amphibians. Field studies conducted in Canada and other regions of North America have demonstrated the reproductive effects of selenium on birds and fish when present at sufficiently high concentrations in the food web, as well as potential impacts on fish populations and biodiversity, all of which affect the integrity of various ecosystems.

Risk quotient analyses were performed by comparing selenium exposure concentrations to predicted no-effect concentrations (PNECs) for fish egg/ovary and fish whole-body tissues, and for the sediment and soil compartments. Based on the screening assessment of selenium and its compounds, it was concluded that concentrations of selenium and its compounds in the environment may cause harm to aquatic, benthic and soil organisms in the vicinity of some facilities for a number of sectors, including

The assessment concluded that selenium and its compounds meet the environmental toxicity criterion set out in paragraph 64(a) of CEPA. However, as releases of selenium and its compounds are not of concern to the broader integrity of the environment, the substances did not meet the criterion set out in paragraph 64(b) of CEPA.

The assessment also concluded that selenium and its compounds meet the persistence and the bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations of CEPA. However, as selenium is a naturally occurring inorganic substance, selenium and its compounds do not qualify for virtual elimination under subsection 77(4) of CEPA.

Human health assessment

With available selenium biomonitoring footnote 4 data, the risk to human health was characterized by comparing the concentrations of selenium in the whole blood of Canadians to concentration levels at which selenium could pose a risk. Whole blood concentrations provide a measure of integrated exposure to all forms of selenium from all routes and sources, including environmental media (i.e. water, air, soil and dust), food and other products. Selenosis was used as the critical health effect associated with exposure to elevated concentration of selenium. Selenosis results from elevated levels of selenium exposure, characterized by hair loss, brittle nails, garlic odour in breath, weakness, decreased cognitive function and gastrointestinal disorders. Selenosis is the basis for many international regulatory reference values, including the tolerable upper intake level (UL) established by the Institute of Medicine (IOM), now the National Academy of Medicine, for North American populations to determine at what concentration levels selenium exposure may pose a risk to human health.

The assessment found that selenium whole blood concentrations in some Inuit who eat traditional foods exceed the whole blood equivalent for the IOM's UL (480 µg/L) and exceed concentration levels at which selenosis has been observed in humans (1 000 µg/L). Additionally, subsistence fishers consuming fish with elevated selenium concentrations caught around point sources of selenium such as mines, smelting and refining facilities, and individuals consuming multivitamin/mineral supplements containing 400 µg (or 0.0004 grams) of selenium are two additional subpopulations in Canada with the potential for elevated selenium exposure.

Therefore, the screening assessment concluded that selenium and its compounds pose a risk to human health and meet the human health criterion for a toxic substance as set out in paragraph 64(c) of CEPA.

Objective

The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to add selenium and its compounds to the List of Toxic Substances in Schedule 1 of CEPA. It enables the ministers to propose a regulation or instrument respecting preventive or control actions to manage potential environmental and human health risks associated with selenium and its compounds.

Description

The Order will add selenium and its compounds to Schedule 1 of CEPA.

Regulatory development

Consultation

On July 18, 2015, the ministers published a summary of the draft screening assessment for selenium-containing substances in the Canada Gazette, Part I, for a 60-day public comment period. Comments were received from industry, provincial governments, First Nations, academics, and private citizens during that period. These comments were considered in developing the final screening assessment report and did not change the conclusion that selenium and its compounds meet the ecological and human health toxicity criteria under paragraphs 64(a) and (c) of CEPA, respectively. A table summarizing the complete set of comments received and the responses to these comments is available on the Canada.ca (Chemical Substances) website.

On February 17, 2018, the proposed Order recommending the addition of selenium and its compounds to Schedule 1 of CEPA was published in the Canada Gazette, Part I, for a 60-day public comment period. During this period, comments were received from three natural health product companies, three industry stakeholders and two non-governmental organizations (NGO). Several of the comments related to managing the risk posed by selenium and its compounds to the environment and to human health and will be considered during the development of the risk management instruments.

Overview of public comments and responses

The NGOs that provided comments supported the addition of selenium and its compounds to Schedule 1 of CEPA, but also made requests for additional measures. These measures included increased research towards selenosis and its effects, dedicated physicians specialized in detecting signs of selenosis, blood tests for subsistence anglers in areas of high selenium concentration and more oversight on industries releasing selenium. Officials responded that research, communication and sharing of expertise with local health authorities and other stakeholders will continue.

Another comment suggested that selenium and its compounds should be added to the Priority Substances List for further assessment because their addition to Schedule 1 of CEPA would be costly for stakeholders and the industry. The addition of substances to Schedule 1 of the Act does not impose any regulatory or administrative burdens; it provides authority to the ministers to introduce risk management or regulatory initiatives for a toxic substance under CEPA, which would be subject to a separate stakeholder consultation process.

Modern treaty obligations and Indigenous engagement and consultation

An assessment of modern treaty implications must be made in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation. It was concluded that orders adding substances to the List of Toxic Substances in Schedule 1 of CEPA do not result in any impact on modern treaty rights or obligations. It was also concluded that the making of an order under section 90 of the Act does not require specific engagement and consultation with Indigenous peoples. In the event that the ministers propose risk management instruments for any substance listed in Schedule 1 of CEPA, the Departments will assess any potential impacts during the development of such measures.

Instrument choice

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:

The implementation of virtual elimination is applicable if

Selenium is a naturally occurring element; therefore, the implementation of virtual elimination does not apply to selenium and its compounds (i.e. its existence is not the result of human activity, although human activities can result in its mobilization and concentration to levels of concern in certain environments and for human health). Based on the available evidence, which includes data received from industry and the conclusions of the screening assessment, the ministers determined that choosing the options in paragraphs 77(2)(a) or (b) of the Act is not appropriate to manage the potential ecological and human health risks associated with selenium and its compounds in Canada. Therefore, the ministers chose the option under paragraph 77(2)(c) of CEPA, and thus recommended to the Administrator in Council to add selenium and its compounds to the List of Toxic Substances in Schedule 1 of CEPA. An order is the only available instrument to implement this recommendation.

Regulatory analysis

Benefits and costs

The addition of selenium and its compounds to the List of Toxic Substances in Schedule 1 of CEPA has no impacts (benefits or costs). The Order addresses the screening assessment conclusion for selenium and its compounds, which determined that these substances meet the ecological and human health criteria for a toxic substance as set out in paragraphs 64(a) and (c) of CEPA. The Order enables the ministers to propose a regulation or instrument respecting preventative or control actions to manage potential ecological and human health risks associated with selenium and its compounds. During the development of risk management instruments, the ministers would assess the benefits and costs and consult with the public and other interested parties.

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 small businesses.

One-for-one rule

The assessment of the one-for-one rule concluded that the rule does not apply to the Order, as it does not impose any new administrative or compliance costs on industry related to current activity.

Regulatory cooperation and alignment

The assessment of regulatory cooperation and alignment concluded that there are no international agreements, obligations, or standards directly associated with orders adding substances to the List of Toxic Substances in Schedule 1 of CEPA. However, the Departments hold several international bilateral and multilateral agreements related to chemicals and chemical management. The CMP is administered in cooperation and alignment with these agreements. For more information on the agreements related to chemicals and chemical management, please see the Compendium of Canada's Engagement in International Environmental Agreements and Instruments.

Although not particular to the Order, there are international risk management activities related to managing human health and ecological risks associated with selenium exposure that align with current risk management activities in Canada (see the “Background” section for details). The United States (U.S.) set minimum and maximum levels for the addition of selenium to infant formulas. The U.S. Food and Drug Administration also limits the use of selenium in chicken, turkey, swine, beef cattle, and dairy feed. The U.S. Environmental Protection Agency also published a Final Aquatic Life Ambient Water Quality Criterion for Selenium. The European Union (EU) and the World Health Organization recommend a limit for selenium in drinking water. Under the EU Cosmetics Regulation, all selenium compounds, with the exception of selenium sulfide, are banned from all cosmetic products. In the United Kingdom, Australia and Singapore, selenium levels are regulated in dietary supplements. A joint guideline for fresh and marine water quality was developed by Australia and New Zealand to protect freshwater species. South Africa developed a chronic effect value for the toxic effect of selenium on aquatic organisms, and India set a standard for a maximum selenium concentration in all industrial effluents to surface waters, marine and coastal areas, and public sewers.

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 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 and establishing service standards are not necessary. A complete assessment of these elements would be undertaken during the development of risk management instruments for selenium and its compounds.

Contacts

Pascal Roberge
Acting Executive Director
Program Development and Engagement Division
Environment and Climate Change Canada
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: eccc.substances.eccc@canada.ca

Andrew Beck
Director
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613‑948‑2585
Email: andrew.beck@canada.ca