Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2019-197
Canada Gazette, Part II, Volume 153, Number 13
SOR/2019-197 June 10, 2019
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2019-756 June 9, 2019
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 June 24, 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:
Cobalt and soluble cobalt compounds
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 Government of Canada (the Government) completed a screening assessment on cobalt and cobalt-containing substances to assess whether these substances may pose a risk to human health or the environment in Canada. The screening assessment concluded that cobalt and soluble cobalt compounds meet the environmental toxicity criterion as defined in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). As a result, the Government is adding cobalt and soluble cobalt compounds to the List of Toxic Substances in Schedule 1 of CEPA.
The Chemicals Management Plan (CMP) is a federal program launched in 2006 to assess and manage chemical substances that may be harmful to human health or the environment. Under the CMP, cobalt and cobalt-containing substances were identified as priorities for ecological and human health assessment.
Substance description and sources of release
Information was reported under section 71 of CEPA for 22 cobalt-containing substances that were manufactured, imported or used in Canada from 2006 to 2011. Four substances were reported to be in commerce in quantities greater than 1 000 tonnes, while the others were in commerce in quantities ranging from tens to hundreds of tonnes. Uses and activities involving cobalt in Canada include its use as an intermediate in metallurgical processes, non-ferrous metal smelting and refining, as a component in alloys and carbides, as feed supplements and fertilizers, and in hard material tools, paints and coatings, plastic, rubber, batteries, and other products available to consumers.
Sources of release of cobalt to the environment from manufacturing involve rubber, chemicals, paints and coatings, plastics (polyester resin), fertilizers and animal feed. In addition, the following sectors have the potential to release cobalt as a by-product: electricity (power generation), petroleum refining, oil sands, pulp and paper mills, electrical and electronic equipment, waste management, wastewater and biosolids. However, the major contributors to releases of cobalt into the environment are the mining, smelting and refining of base metals, such as copper and nickel.
Cobalt is being released from mining facilities when, during the mining process, water comes into contact with cobalt-containing rock, ore and tailings. This cobalt dissolves into the contact water and is then released mainly as part of the effluent of the mine. Cobalt continues to be released from mine waste storage areas (waste rock or tailings) long after the mine has ceased operation. Similar to mines, smelters and refineries release cobalt to the environment given that this metal is present in a variety of ores or concentrate being processed. Smelters that produce nickel often have ores containing cobalt.
In 2011, 44 mines and mills reported on cobalt and its compounds to the National Pollutant Release Inventory. Reported releases to air, water and land, for that year, totalled 4.3 tonnes, while on-site disposal (including information on the disposal of tailings and waste rock containing cobalt) amounted to 3 637 tonnes, and transfers off-site for disposal were 88 kg.
International risk management activities
In the United States, effluent containing cobalt is regulated by the Effluent Limitations Guidelines under Title 40: Protection of Environment in the United States Code of Federal Regulations. These guidelines recommend, based on the best practicable control technology currently available, different maximum daily limits and maximum monthly averages for the release of cobalt into the environment for various point source categories.
In Europe, five forms of soluble cobalt compounds [cobalt dichloride, cobalt(II) carbonate, cobalt(II) diacetate, cobalt(II) dinitrate and cobalt(II) sulphate] are currently listed on the Candidate List of Substances of Very High Concern for Authorisation, as part of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation implemented by the European Union. Substances on this list are expected to pose a high concern for human health and/or the environment. In 2011, these five cobalt compounds were recommended for inclusion in Annex XIV. If included in Annex XIV, these substances would no longer be allowed on the European market after a set date, unless an authorization is granted (European Chemicals Agency, 2013).
In Australia, the Environment Protection Authority manages the releases of cobalt with the Standard for the Production and Use of Waste Derived Fill, as listed in the Environment Protection Regulations 2009 under the Environment Protection Act 1993. This standard limits chemical substances found in the treatment of waste or waste materials to be used as fill by setting a maximum concentration of 170 mg/kg for cobalt in waste.
Summary of the screening assessment
An assessment of cobalt and cobalt-containing substances was conducted by the Government to determine if these substances met one or more of the criteria for a toxic substance set out in section 64 of CEPA. Specifically, this involves determining whether substances are entering or might 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 human health and ecological assessment focuses on all forms of cobalt, from natural and human-made sources. Therefore, it is not limited to the cobalt-containing substances identified in the screening assessment.
Human health assessment summary
Data on general population exposure to cobalt from all sources, including environmental media (i.e. water, soil, sediment and air), food and the use of products (e.g. paints and coatings) was analyzed. The concentration of cobalt measured in blood was determined to reflect exposure to all forms of cobalt from all routes and all sources. Specifically, cobalt was measured in the blood and urine of over 6 000 Canadians aged 3 to 79 years at 18 sites across Canada from 2009 to 2011 as part of the Canadian Health Measures Survey (CHMS) biomonitoring study. To assess whether the substances had the potential to pose a risk to human health in Canada, estimates of exposure, based on concentration levels found in blood samples from the CHMS survey were compared with the concentration levels, based on toxicity studies, at which critical health effects might occur in humans. The human health assessment determined that, for the general population of Canada, exposure to cobalt from all sources is not a concern to human life or health. footnote 2 Therefore, the screening assessment concluded that the substances do not meet the human health toxicity criterion as defined in paragraph 64(c) of CEPA.
Ecological assessment summary
Cobalt is highly toxic to sensitive aquatic organisms, sediment-dwelling organisms and terrestrial organisms. The survival, growth or reproduction of these organisms may be threatened by exposure to cobalt. In addition, biological diversity and the stability of the food chain may be adversely impacted by cobalt (e.g. reduction in the quality and quantity of fish food sources). There is experimental evidence that cobalt causes harm to aquatic freshwater organisms, such as invertebrates, algae/plants, and fish, following short-term (acute) and longer term (chronic) exposure at very low concentrations. Survival, growth, or reproduction of these organisms may be affected.
The assessment presented field measurements or estimated concentrations of cobalt in water and air at selected sites representing nine industrial sectors. The areas where concentrations were measured or estimated are, for the vast majority, in the vicinity of facilities and installations where cobalt may be released in effluents or emitted to air. Total or dissolved cobalt concentrations were measured in receiving watercourses, sediments or soils and are presented in the assessment as predicted environmental concentrations (PEC). In parallel, predicted no effect concentrations (PNEC) were developed based on the laboratory toxicity studies considered for cobalt. The PNEC basically provides an estimate of the concentrations of substances above which they may become harmful to non-human organisms. The analysis determined that the PEC was above the PNEC in the vicinity of facilities where cobalt is being released to the aquatic environment.
A total of 40 locations or areas of concern covering four sectors were identified where the PEC is expected to be above the PNEC, and thus where concentrations of cobalt in the environment are of concern to aquatic organisms near sources of release. These sectors are metal mining, base metals smelting and refining, pulp and paper mills, and landfills. In addition to those areas, locations of concern have also been identified for historical mining and metal mining exploration activities. Releases of effluent were found to be the most important source of exposure for aquatic organisms near these activities. In addition, 14 areas covering two sectors (metal mining and base metals smelting and refining) were identified as being of concern for sediment-dwelling organisms, and three areas from the base metals smelting and refining sector were identified as posing a risk to terrestrial organisms. footnote 3
Considering all available lines of evidence presented in the screening assessment, it was concluded that cobalt and cobalt soluble compounds pose a risk to non-human organisms near sources of release and meet the environmental toxicity criterion as defined under paragraph 64(a) of CEPA. The screening assessment also concluded that the substances do not pose a risk to the broader integrity of the environment, and therefore do not meet the toxicity criterion under paragraph 64(b) of CEPA.
The objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Government to propose risk management measures for toxic substances under CEPA to manage potential environmental risks associated with cobalt and soluble cobalt compounds.
The Order will add cobalt and soluble cobalt compounds to Schedule 1 of CEPA.
The “One-for-One” Rule does not apply, as the Order will not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the Order will not impose any compliance or administrative costs on small business.
The draft screening assessment was peer-reviewed, and additional advice was sought through the Challenge Advisory Panel. On December 6, 2014, a summary of the draft screening assessment (PDF) (B) for cobalt and cobalt-containing substances was published in the Canada Gazette, Part I, for a 60-day public comment period. During the 60-day public comment period, more than 45 sets of comments were received from 13 industry stakeholders. All comments were considered during the development of the final screening assessment for cobalt and cobalt-containing substances, which was published in May 2017 on the Canada.ca (Chemical Substances) website. These comments, however, did not change the conclusion that cobalt and soluble cobalt compounds meet the ecological toxicity criterion under paragraph 64(a) of CEPA. A table summarizing the complete set of comments received and the Government’s responses is available on Canada.ca (Chemical Substances) website.
On June 24, 2017, the proposed Order recommending the addition of cobalt and soluble cobalt compounds to Schedule 1 of CEPA was published in the Canada Gazette, Part I, for 60-day public comment period, which included a summary of the comments received on the draft screening assessment and the Government’s responses. footnote 4 During the 60-day public comment period for the proposed Order, one comment was received from an industry association which had previously recommended a narrower focus on soluble forms of cobalt compounds, arguing that its members (i.e. in the paint sector) use forms of cobalt and cobalt compounds that have no potential to dissolve in ways that can be harmful for the environment.
The industry association indicated that although it was more satisfied that the proposed listing name was restricted to soluble forms of cobalt and its compounds, it would prefer a listing that is specific to the 50 individual substances identified in the screening assessment or additional information pointing to the list of substances of concern. Government officials explained that the screening assessment focused on all forms of cobalt in its elemental form, cobalt-containing substances and cobalt released in dissolved, solid or particulate form. The conclusion that cobalt and soluble cobalt compounds are harmful to the environment covers more substances than the 50 individual substances listed in the screening assessment.
The association argued that the current listing name could lead to unintentional impacts on its sector (e.g. paint formulations) and as such suggested that an explanatory note be added to the Order to clarify that insoluble forms of cobalt compounds as well as uses of cobalt substances from certain sectors were not found to be a risk to the environment. Government officials noted that a risk management approach (RMA) document was published on May 27, 2017, on the Canada.ca (Chemicals Substances) website outlining the proposed risk management actions the Government is planning to implement for cobalt and soluble cobalt compounds. The RMA focuses on the risks identified in the screening assessment from releases of cobalt and soluble cobalt compounds to water from metal mining, base metal smelting, waste management — landfills, and pulp and paper sectors. In addition, the Government will assess the costs and benefits and consult with the public and other stakeholders during the development of any risk management proposals for toxic substances under CEPA to manage environmental risks associated with cobalt and soluble cobalt compounds.
Prior to these publications, the Department of the Environment and the Department of Health had informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of these documents and of the related public comment period aforementioned. No comments were received from CEPA NAC. footnote 5
Based on the review of the data submitted by industry and collected and generated by the Government as part of the screening assessment process, it was determined that cobalt and soluble cobalt compounds pose an ecological risk near sources of release. Cobalt, once dissolved in water, may be taken up by aquatic-, soil-, and sediment-dwelling organisms to which it has been demonstrated to cause harm at very low concentrations in terms of survival, growth, or reproduction. As a result, the screening assessment concluded that cobalt and soluble cobalt compounds meet the environmental toxicity criterion as defined under paragraph 64(a) of CEPA.
One of the following measures must be proposed after a screening assessment is conducted under CEPA:
- 1. taking no further action with respect to the substance;
- 2. adding the substance to the Priority Substances List for further assessment; or
- 3. 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.
Based on the available evidence, which includes data received from industry and the conclusions of the screening assessment, the Government determined that choosing options 1 or 2 is not appropriate to manage potential ecological risk associated with cobalt and soluble cobalt 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 chosen by the Government. footnote 6
The addition of cobalt and soluble cobalt compounds to Schedule 1 of CEPA will not result in any incremental impacts (benefits or costs) on the public or industry, since there are no compliance requirements. Accordingly, there is no compliance or administrative burden on small business or businesses in general.
The Government will assess the costs and benefits and consult with the public and other stakeholders during the development of risk management proposals under CEPA for cobalt and soluble cobalt compounds.
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. 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.
Implementation, enforcement and service standards
The Order adds cobalt and soluble cobalt compounds to Schedule 1 of CEPA, thereby enabling the Government to propose risk management measures respecting preventive or control actions for toxic substances 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 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 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