Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE
June 24, 2017
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) has conducted a screening assessment of cobalt and cobalt-containing substances to determine whether the substances may pose a risk to human health or to the environment. (see footnote 1) Cobalt was found harmful to non-human organisms, and soluble cobalt compounds, whe... (Click for more)
Published on June 25, 2017
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) has conducted a screening assessment of cobalt and cobalt-containing substances to determine whether the substances may pose a risk to human health or to the environment. (see footnote 1) Cobalt was found harmful to non-human organisms, and soluble cobalt compounds, when released to the environment from human activities, were found to contribute to the overall exposure of non-human organisms to cobalt as they are expected to dissolve, dissociate or degrade in the environment (e.g. water and sediment). The screening assessment determined 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). Therefore, the Government is proposing to add cobalt and soluble cobalt compounds to the List of Toxic Substances in Schedule 1 of CEPA. Background The Chemicals Management Plan (CMP) (see footnote 2) is a federal program that assesses and manages chemical substances that may be harmful to human health or the environment. Since the CMP was launched in 2006, more than 60% of the 4 300 substances identified as priorities for assessment have been assessed and risk management action initiated (where necessary) to mitigate environmental and human health risks identified during their assessment. Cobalt and cobalt-containing substances, which include cobalt and soluble cobalt compounds, were some of the priorities identified under the CMP. Substances description and sources of release Information was reported under section 71 of CEPA (see footnote 3) 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, and batteries. The human health and ecological assessment focuses on the cobalt moiety; that is, 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. 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, disposal and 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, specifically, often have ores containing cobalt. In 2011, 44 mines and mills reported on cobalt and its compounds to the National Pollutant Release Inventory. (see footnote 4) Reported releases to air, water and land, for that year, totalled 4.3 tonnes, while on-site disposal (including information on the disposal of taillings and waste rock containing cobalt) amounted to 3 637 tonnes, and transfers off-site for disposal were 88 kg. (see footnote 5) 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 Authorization, as part of the Registration, Evaluation, Authorization 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 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 assessment The Government has conducted a screening assessment of cobalt and cobalt-containing substances to determine if these substances would 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. 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 whole blood was determined to reflect exposure to all forms of cobalt from all routes and all sources. Therefore, to assess whether the substances have the potential to pose a risk to human health in Canada, estimates of exposure, based on concentration levels found in whole blood samples from a nationally representative survey, (see footnote 6) were compared with the concentration levels, based on toxicity studies, at which critical health effects may occur in humans. The results of this analysis showed that, for the general population of Canada, exposure to cobalt from all sources is not a concern to human life or health. (see footnote 7) Therefore, the screening assessment concluded that the substances do not meet the human health 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 affected. 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. The assessment presented field measurements or estimated concentrations of cobalt in relevant environmental media (e.g. water and air) for selected sites representing nine industrial sectors. The areas where these 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 (industrial releases to air which may be deposited to the water or soil compartments were also included) 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 leachate (from landfills). In addition to those areas, locations of concern have also been identified for historical mining and metal mining exploration activities. Releases of liquid 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 3 areas from the base metals smelting and refining sector were identified as posing a risk to terrestrial organisms. (see footnote 8) 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 and meet the environmental 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 on which life depends, and therefore do not meet the criterion under paragraph 64(b) of CEPA. Publication and conclusions In May 2017, the final screening assessment for cobalt and cobalt-containing substances was published on the Government of Canada’s Chemical Substances website. Based on the results of the final screening assessment, the ministers have concluded that cobalt and soluble cobalt compounds meet the environmental criterion for a toxic substance, as set out under paragraph 64(a) of CEPA, and have therefore recommended the addition of cobalt and soluble cobalt compounds to Schedule 1 of CEPA. (see footnote 9) Objective The objective of the proposed 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 under CEPA to manage potential environmental risks associated with cobalt and soluble cobalt compounds, should such measures be deemed necessary. Description The proposed Order would add cobalt and soluble cobalt compounds to Schedule 1 of CEPA. “One-for-One” Rule 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. Consultation On December 6, 2014, the ministers published a summary of the draft screening assessment for cobalt and cobalt-containing substances in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 10) On the same date, the risk management scope document outlining the preliminary options being examined for the management of the substances was released on the Chemical Substances website. (see footnote 11) During the 60-day public comment period, 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. (see footnote 12) A table summarizing the complete set of comments received and the Government’s responses is available on the Chemical Substances website. (see footnote 13) 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. (see footnote 14) Overview of public comments and responses Comments received focused on the methodology used to characterize risk and the information used in the screening assessment. A more fulsome summary of the comments and responses are available on the Chemical Substances website. Methodology: Stakeholders commented on the methodology used to derive risk quotients (comparison of PEC and PNEC) in some scenarios and suggested that different approaches be used as they noted some limitations in some of the parameters of the current approach. The Government responded to stakeholders’ comments noting the limitations and providing additional context and details explaining the reason for selecting the current method, which overall is expected to provide the best estimation of risk. Stakeholders commented that the frequency, magnitude and cause of risk quotients exceeding 1 (PEC > PNEC) from mining and base metals smelting and refining sectors, are overstated in the screening assessment. Stakeholders added that cobalt-concentrations of concern were not identified during industry-related monitoring activities, and that the highest risk quotients reported in the screening assessment likely represent abandoned mine sites and were therefore not issues on a national scale. The Government responded that based on new information provided as part of the public comment period, adjustments in risk quotient calculations have been made. While this resulted in fewer active mines, smelters or refineries sites where a risk was identified, approximately half of the sites examined were determined to have cobalt-concentrations of concern. Information sources and data used: Some stakeholders commented that further detail on the essentiality of cobalt, its presence in vitamin B12, and its addition to food under the Food and Drug Regulations should be included in the assessment. In theory, cobalt levels in blood would normally be detected due to its presence in vitamin B12. Similarly, the assessment should reflect the fact that the presence of free cobalt in vitamin B12 does not contribute to any potential negative health effects. Government officials added further information in the final screening assessment to clarify the presence of cobalt in food and humans due to its presence in vitamin B12. A stakeholder commented that more recent studies on inhalation epidemiology, absorption, distribution, metabolism and excretion in humans, and mechanism of toxicity should be included in the screening assessment and should be used in determining risk to human health. The noted studies were included and considered in the final screening assessment. Rationale Based on the review of the data submitted by industry and collected and generated by the ministers as part of the screening assessment process, it was determined that cobalt and soluble cobalt compounds are being released in the Canadian environment in quantities or at concentrations that may be harmful to non-human organisms. Cobalt, once dissolved in water from the substances, 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. Therefore, cobalt and soluble cobalt compounds were determined to have the potential to cause ecological harm as defined under paragraph 64(a) of CEPA. One of the following measures must be proposed after a screening assessment is conducted under CEPA: taking no further action with respect to the substance; adding the substance 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 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 proposed by the ministers. (see footnote 15) The proposed addition of cobalt and soluble cobalt compounds to Schedule 1 of CEPA would not result in any incremental 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 risks associated with the substances. If further risk management measures are deemed necessary for cobalt and soluble cobalt 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 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 was completed. (see footnote 16) Implementation, enforcement and service standards The proposed Order would add cobalt and soluble cobalt 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, 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. Contacts Greg Carreau Program Development and Engagement Division Department of the Environment Gatineau, Quebec K1A 0H3 Substances Management Information Line: 1-800-567-1999 (toll-free in Canada) 819-938-3232 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Michael Donohue Risk Management Bureau Department of Health Ottawa, Ontario K1A 0K9 Telephone: 613-957-8166 Fax: 613-952-8857 Email: [email protected] 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 a Toxic Substance 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 addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 819-938-5212; email: [email protected]). 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, June 19, 2017 Jurica Čapkun Assistant Clerk of the Privy Council Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 Amendment 1 Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 17) is amended by adding the following: Cobalt and soluble cobalt compounds Coming into Force 2 This Order comes into force on the day on which it is registered. [25-1-o] Footnote 1 For more information on the screening assessment of cobalt and cobalt-containing substances, please visit http://www.chemicalsubstanceschimiques.gc.ca/group/cobalt-eng.php. Footnote 2 For more information on the CMP, please visit the Chemical Substances website at http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php. Footnote 3 For more information on section 71 of CEPA, please see https://www.ec.gc.ca/lcpe-cepa/26A03BFA-C67E-4322-AFCA-2C40015E741C/lcpe-cepa_201310125_loi-bill.pdf. Footnote 4 For more information on the National Pollutant Release Inventory, please visit https://www.ec.gc.ca/inrp-npri/. Footnote 5 For general information on substance releases, disposals and transfers, please see http://www.ec.gc.ca/inrp-npri/default.asp?lang=En&n=DD37B0ED-1#a3_5_3. Footnote 6 Cobalt is one of the chemical substances measured as part of the Canadian Health Measures Survey (CHMS) biomonitoring study. 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. Footnote 7 For more information on the human health assessment, please see the screening assessment report for cobalt and cobalt-containing substances at http://www. chemicalsubstanceschimiques.gc.ca/group/cobalt-eng.php. Footnote 8 For more information on the ecological assessment for the substances, please see the screening assessment report for cobalt and cobalt-containing substances on the Chemical Substances website. Footnote 9 The final assessment report and other related publications can be obtained from the Chemical Substances website or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3; 1-800-567-1999 (toll-free in Canada); 819-938-5212 (fax); [email protected] (email). Footnote 10 For more information, please see http://canadagazette.gc.ca/rp-pr/p1/2014/2014-12-06/pdf/g1-14849.pdf. Footnote 11 For more information on the Risk Management Scope document, please visit http://www.chemicalsubstanceschimiques.gc.ca/group/cobalt-eng.php. Footnote 12 For information on the comments and the Government responses to these comments, please visit http://www. chemicalsubstanceschimiques.gc.ca/group/cobalt-eng.php. Footnote 13 For information on the comments and the Government responses to these comments, please visit http://www. chemicalsubstanceschimiques.gc.ca/group/cobalt-eng.php. Footnote 14 Section 6 of CEPA provides that the CEPA NAC be the main intergovernmental forum for the purpose of enabling national action and avoiding duplication in regulatory activity among governments within Canada. This committee has a representative from the Department of the Environment and the Department of Health, a representative of each of the provinces and territories as well as up to six representatives of Aboriginal governments. Footnote 15 The implementation of virtual elimination does not apply to cobalt and soluble cobalt compounds. Footnote 16 For more information, please see http://www. chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php. Footnote a S.C. 2004, c. 15, s. 31 Footnote b S.C. 1999, c. 33 Footnote 17 S.C. 1999, c. 33
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