Canada Gazette, Part I, Volume 152, Number 7: Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
February 17, 2018
Canadian Environmental Protection Act, 1999
Department of the Environment
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
In 2017, the Government of Canada (the Government) completed a screening assessment on selenium and its compounds to determine whether the substances may pose a risk to the environment or human health. (see footnote 1) The screening assessment determined that as a result of human activities, selenium and its compounds are being released into the environment in a quantity or concentration that is harmful to human health and the environment. It was concluded that selenium and its compounds meet the criteria for a toxic substance as set out in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). As a result, the Government is proposing to add selenium and its compounds to the List of Toxic Substances in Schedule 1 of CEPA.
The Chemicals Management Plan (CMP) (see footnote 2) is a federal program, launched in 2006, under which chemical substances that may be harmful to the environment or human health are assessed and managed. Between 2006 and 2016, more than 60% of the 4 300 substances identified as priorities under the CMP were assessed. Based on the results of these assessments, risk management actions have been initiated where necessary to mitigate environmental and human health risks associated with exposures of concern to these substances. One of the priorities under the CMP is selenium and its compounds.
Substances description, uses and sources of release
Selenium is a naturally occurring element in the earth's crust and 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 as a result of 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 in recent years (2010 to 2014), on average, about 26 000 kg of selenium were released to water and 16 000 kg of selenium were released to air annually. The reported releases to land and unspecified releases are not significant compared to releases to water and air.
Selenium is an essential nutrient to human health. All Canadians are exposed to selenium through their diet, as it is naturally occurring in certain foods. It is also used in certain food, 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. (see footnote 3) Selenium production in Canada fluctuated between 97 000 kg and 191 000 kg a year during 2005–2012.
Canadian and international risk management activities
The Government of Canada regulates certain industries to mitigate the risk that selenium and its compounds may pose to the environment and/or human health from elevated or insufficient exposure. Selenium is regulated in infant formula, formulated liquid diets, and in meal replacements and nutritional supplements under the Canadian Food and Drug Regulations of 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, (see footnote 4) and, with the exception of selenium sulfide, (see footnote 5) 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 Mining Effluent Regulations (MMER), under the Fisheries Act, require metal mines to undertake environmental effects monitoring studies with regard to selenium in 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. Base metals smelters and refineries are required to prepare and implement pollution prevention plans that include annual release limits for particulate matter, which contains most metals and metalloids emitted to air, such as selenium. Also, the Environmental Code of Practice for Base Metals Smelters and Refineries recommends particulate matter emissions limits to air and, following CCME, water quality objectives limits of selenium to water. 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 of secondary treatment for wastewater effluent, which results in the removal of selenium to varying degrees.
The United States has adopted an upper limit for selenium intake from all sources and minimum and maximum levels are set out for 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 (the U.S. EPA) also published the Aquatic Life Ambient Water Quality Criterion for Selenium — Freshwater 2016.
The European Union (EU) and the World Health Organization recommend a limit for selenium in drinking water. (see footnote 6) 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 (see footnote 7) 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. (see footnote 8)
Summary of the screening assessment
The Government conducts screening assessments, which include an ecological and a human health assessment on substances to determine if they may pose a risk to the environment or human health in Canada. The assessment determines if the substances meet one or more of the criteria for a toxic substance, as described in section 64 of CEPA. Specifically, this involves determining whether substances are 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 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 under paragraphs 64(a) and (c) but not (b) of CEPA. Below are summaries of the ecological and human health assessments.
Selenium is an essential micronutrient taken up by aquatic and 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, the most sensitive class of aquatic organisms, are 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). In fish, excess 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 these analyses, concentrations of selenium in the environment may cause harm to aquatic, benthic and soil organisms in the vicinity of some facilities for a number of sectors, including
- coal and metal mining;
- base metals smelting and refining; and
- publicly owned wastewater treatment systems.
The assessment concluded that selenium and its compounds meet the environmental toxicity criterion as defined under 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 defined under 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 element, with both natural and anthropogenic sources, it does not qualify for virtual elimination (VE) under subsection 77(4) of CEPA. (see footnote 9)
Human health assessment
With available selenium biomonitoring (see footnote 10) 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 an elevated concentration of selenium. Selenosis occurs 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) 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 subpopulations of Canadians exceed the IOM UL (480 µg/L) and exceed concentration levels at which selenosis has been observed in humans (1 000 µg/L). Some Inuits who eat traditional foods have been identified as a subpopulation with elevated exposure to selenium. Subsistence fishers consuming fish with elevated selenium concentrations 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. The assessment led to a conclusion that some Inuits in northern Canada have blood selenium levels exceeding the IOM UL, that high fish consumption around point sources of selenium such as some mines, smelting and refining facilities exceed the health-based screening value, based on the IOM UL, and that there is a potential risk for individuals taking multivitamin/mineral supplements for adults with the maximum allowed selenium concentration.
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 defined in paragraph 64(c) of CEPA.
Publication and conclusions
On December 16, 2017, the final screening assessment for selenium and its compounds was published on the Canada.ca (Chemical Substances) website. (see footnote 11) Based on the results of the final screening assessment, the Minister of the Environment and the Minister of Health (the ministers) have concluded that selenium and its compounds meet the environmental and human health criteria for a toxic substance, as set out under paragraphs 64(a) and 64(c) of CEPA, respectively, and have therefore recommended the addition of selenium and its compounds to Schedule 1 of CEPA. (see footnote 12)
The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) is to enable the Government to propose risk management measures under CEPA to manage potential environmental and human health risks associated with selenium and its compounds, should such measures be deemed necessary.
The proposed Order would add selenium and its compounds to Schedule 1 of CEPA.
The "One-for-One" Rule does not apply, as the proposed Order would not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the proposed Order would not impose any compliance or administrative costs on small business.
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. During that period, comments were received from industry and industry associations, certain provincial governments, First Nations, academics, and private citizens. These comments were considered during the development of the final screening assessment report for selenium-containing substances. A table summarizing the complete set of comments received and the Government's responses is available on the Canada.ca (Chemical Substances) website (www.canada.ca/en/health-canada/services/chemical-substances.html). The key areas in which comments were received and the Government's responses are summarized below.
Overview of public comments and responses
Comments received focused on the methodology, hazard characterization, and exposure data.
Comments suggested that the PNECs were too low and would not differentiate between reference areas and anthropogenically impacted areas, were based on unreliable data, or did not follow the Canadian Council of Ministers of the Environment (CCME) Protocol for the Derivation of Water Quality Guidelines for the Protection of Aquatic Life 2007.
In response, the Government re-evaluated several studies and revised species endpoint selections to be better aligned with CCME protocol endpoint selection (noting that the cited CCME protocol addresses water concentrations, not fish tissues). The egg/ovary PNEC was recalculated with the revised endpoints. The whole-body PNEC was also recalculated using the revised endpoints and species-specific conversion factors published by the U.S. EPA.
Hazard and risk characterization
Multiple comments were made regarding the finding that dietary exposure to selenium is harmful to human health and requested that more information be included in the screening assessment report (SAR).
The Government responded by indicating that the SAR states that the human health risks of selenium were focused on three subpopulations in Canada that, through their diet, could be exposed to elevated concentrations of selenium. These subpopulations are: (1) some Inuit populations in northern Canada that maintain a traditional diet, including consumption of marine mammals; (2) subsistence fishers who consume fish with elevated concentrations of selenium; and (3) persons who take multivitamin/mineral supplements with the maximum permissible level of selenium. Information was added in the SAR on the benefits and risks of dietary exposure to selenium and on the co-exposure to mercury in diet. Data on the levels of selenium in the traditional foods of First Nations were also added.
Several stakeholders commented that the human health risks associated with subsistence fishing are overstated and should not be associated solely with the mining industry.
The Government responded that the SAR was updated to reflect elevated concentrations of selenium in fish associated with several sectors. However, selenium concentrations were found to be high in fish in many lakes in Canada around mines, and these selenium concentrations exceed the screening value for subsistence fishers. More information on fish consumption advisories in Canada was also added.
Exposure data: Stakeholders made multiple comments regarding the reporting and accuracy of the ecological exposure data presented in the assessment.
The Government responded by indicating that the reporting of ecological exposure data in the assessment was improved by following a consistent methodology and that the accuracy of ecological exposure data was strengthened by adding or correcting concentrations, locations, sample sizes, and references, where appropriate.
Some commenters pointed out that selenium is an essential nutrient and that this should be considered more in the assessment. For example, available epidemiological studies suggest that selenium has a beneficial effect on chronic health problems such as certain types of cancers and type II diabetes.
The Government responded that the essentiality of selenium was taken into consideration. The Government's key priority for food safety and nutrition encompasses healthy diets. However, no changes were made to the dietary reference intakes because the purpose of CMP assessments is to determine toxicities associated with exposure to substances that may result in adverse effects to the environment and human health.
The Government has completed a screening assessment on selenium and its compounds to determine whether the substances may pose a risk to the environment or human health.
Based on the review of available information, it is concluded that selenium and its compounds may cause harm to aquatic, benthic and soil organisms. The organisms most sensitive to continuous exposure to high levels of selenium are egg-laying vertebrates (fish, birds, amphibians).
The assessment also found that selenium whole blood concentrations in some subpopulations of Canadians may exceed levels at which selenosis has been observed in humans. Some Inuit who eat traditional foods have been identified as a subpopulation with elevated exposure. Subsistence fishers who consume fish with elevated selenium concentrations (e.g. from lakes around mining operations) and individuals taking multivitamin/mineral supplements providing higher levels of selenium are two additional subpopulations in Canada with the potential for elevated selenium exposure.
Therefore, selenium and its compounds were determined to have the potential to cause harm to the environment and human health as defined under paragraphs 64(a) and 64(c) of CEPA. As a result, one of the following measures must be proposed after a screening assessment is conducted under CEPA:
- taking no further action with respect to the substances;
- adding the substances to the Priority Substances List for further assessment; or
- recommending that the substances be added to the List of Toxic Substances in Schedule 1 of CEPA, and where applicable, recommending the implementation of virtual elimination.
Based on the available evidence, which includes data received from industry and the conclusions of the screening assessment, the Government has determined that choosing options 1 or 2 is not appropriate to manage potential environmental and human health risks associated with selenium and its compounds in Canada. Therefore, option 3, which recommends that the substances be added to the List of Toxic Substances in Schedule 1 of CEPA, is the option proposed by the ministers. (see footnote 13)
The addition of selenium and its compounds to Schedule 1 of CEPA would not result in any direct impacts (benefits or costs) on the public or industry, since the proposed Order would not impose any compliance requirements on stakeholders. Accordingly, there would be no compliance or administrative burden imposed on small businesses or businesses in general. Rather, the proposed Order enables the Government to propose risk management measures under CEPA, should such measures be deemed necessary to manage potential ecological and human health risks associated with the substances.
If further risk management measures are deemed necessary for selenium and its compounds, the Government will assess the costs and benefits and consult with the public and other stakeholders during the development of any risk management measure to address potential environmental and human health concerns associated with uses of the substances in Canada.
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment (SEA) was completed under the CMP. (see footnote 14) The detailed analysis that was completed as part of the SEA indicated that the CMP will have a positive effect on the environment and human health. For more information, please see the following link: http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php.
Implementation, enforcement and service standards
The proposed Order adds selenium and its compounds to Schedule 1 of CEPA, thereby enabling the Government to propose risk management measures respecting preventive or control actions under CEPA. Developing an implementation plan and an enforcement strategy and establishing service standards are only considered necessary when a specific risk management approach is proposed. As the proposed Order does not include a specific risk management proposal, there is no requirement for implementation, enforcement, or service standards.
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
- 1-800-567-1999 (toll-free in Canada)
- 819-938-3232 (outside of Canada)
Risk Management Bureau
Department of Health
PROPOSED REGULATORY TEXT
Notice is given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 819-938-5212; email: firstname.lastname@example.org).
A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.
Ottawa, February 8, 2018
Assistant Clerk of the Privy Council
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 15) is amended by adding the following in numerical order:
- 146 Selenium and its compounds
Coming into Force
2 This Order comes into force on the day on which it is registered.