Follow-up report to the Standing Committee on the Canadian Environmental Protection Act: chapter 3
3 Controlling toxic substances and living organisms
3.1 The Chemicals Management Plan
The Canadian Environmental Protection Act, 1999 (CEPA) provides the primary legislative basis for the CMP. The Minister of Health and the Minister of Environment and Climate Change (ECCC) jointly administer the Chemicals Management Plan (CMP), which includes the assessment and management of health and environmental risks from a broad range of “substances”, which includes chemicals, polymers, greenhouse gases, industrial effluents, and living organisms. Many organizations in Canada and internationally agree that Canada’s chemical management regime is one of the most effective in the world. The Committee’s report included statements from many witnesses praising the CMP.
The management cycle illustrated in figure 1 depicts the basic steps in the CMP: information is collected to understand risks and inform decisions; risks are assessed to determine if action is required; and risk management measures are put in place to prevent the risks. The government supports the effective implementation of these measures with compliance promotion and enforcement actions. Finally, information is once again collected to monitor progress, report to Canadians, and determine whether additional action is required.
Figure 1: The CMP management cycle
Long description for figure 1
This diagram shows the steps of the CEPA management cycle:
- risk assessment
- risk management for toxics, air pollution and greenhouse gases, water quality, and waste
- compliance promotion and enforcement
- information gathering, research and monitoring
- reporting, stakeholder engagement, public rights and inter-jurisdictional relationships
Engaging stakeholders and the public is central to the CMP. At each stage in the cycle, stakeholders are engaged, the public has the opportunity to be involved, the government works closely with provincial, territorial and Indigenous counterparts, and information is reported to the public. The government publishes rolling work plans for information gathering, risk assessment, as well as risk management activities and consultations. Further program implementation information is also available online.
External bodies also support the implementation of the CMP. The CMP Science Committee helps to ensure that the CMP has a strong science foundation. The Science Committee meets biannually, and may hold additional meetings on an as-needed basis. The CMP Stakeholder Advisory Council fosters dialogue among different stakeholder groups and offers them the opportunity to provide advice and input to government on policy and program implementation of tools and requirements. The Stakeholder Advisory Council also meets biannually, with the possibility of additional technical meetings or discussions. In addition, the CMP program also holds biannual Multi-Stakeholder Workshops with a focus on engagement with a broader group of stakeholders on current and future CMP topics.
More information on the CMP can be found on the CMP webpage.
3.2 Chemicals management after 2020
More than 23,000 chemical substances were in commercial use in Canada between January 1, 1984 and December 31, 1986, when the original CEPA (CEPA 1988) was being created. These “existing” substances were placed on the domestic substances list (DSL). Any substance that is not on the DSL is a “new” substance and must go through a rigorous notification process before it can be used. This process allows the government to ensure that new substances do not enter the market without appropriate controls in place to address any health or environmental risks. Most developed countries have similar pre-market notification and assessment processes for new substances.
When CEPA 1988 was replaced in 1999, Canada, like most other countries, was trying to determine the best way to deal with the many thousands of legacy substances that were already in widespread use when the new substances regime was adopted. The solution, codified in the current version of CEPA, was to create a requirement for ECCC and Health Canada (HC) to "categorize" all 23,000 substances that were on the DSL, and to conduct further assessments of those substances that met certain prescribed criteria. These criteria identified substances that are inherently toxic and persistent or inherently toxic and bioaccumulative as well as those substances with “the greatest potential for exposure” to Canadians. This categorization requirement was relatively unique. Most other countries focused their efforts on substances used in very high volumes.
In 2006, the government completed the triage of the 23,000 existing substances on the DSL, and identified 4,300 substances requiring further attention. The goal of the CMP is to address all 4,300 substances by 2020. More information on the categorization process is available on-line..
As of May 1, 2018, the CMP has addressed 3,160 of the substances identified during the categorization process. The current phase of the CMP, launched in May 2016, will address the remaining substances by March 31, 2021. With the conclusion of the current CMP nearing, the government is taking action to set new directions and objectives for chemicals management post-2020.
Canada is not alone in considering the future direction of chemicals management. Other countries are working under the Strategic Approach to International Chemicals Management (SAICM)—a policy framework to promote chemical safety around the world—to consider the next evolution of responsible chemical and waste management.
To help the government set new direction and objectives for chemicals management, it has initiated a broad-based engagement with partners and stakeholders that will continue through 2018 and 2019 to determine the future direction of chemicals management in Canada beyond 2020. Many of the chemicals management issues raised by the committee will help inform this engagement, which will examine such issues as endocrine disrupting chemicals, vulnerable populations, cumulative risk assessments, risk management, labelling, priority-setting, alternatives assessments and informed substitution, and substances of very high concern. The outcome of this process will help shape program activities and, where needed, reforms to the act itself.
3.3 Information gathering
3.3.1 Information gathering provisions
A range of information is considered in risk assessments and in determining the most appropriate way to manage any risks identified, including: chemical properties, quantities manufactured in or imported into Canada, releases to and concentrations in the environment, environmental fate and behaviour, hazards, and nature of exposure. Information is collected and considered through a number of existing authorities under the act. These include tools and powers under sections 46, 68, 70, 71 and 75, as well as authorities and requirements for information regarding new substances and activities, such as the significant new activity (SNAc) provisions in sections 85, 87, 110 and 112.
More information on the government’s information gathering activities under the CMP is available online.
The committee made several recommendations regarding information gathering under CEPA. The government agrees with the committee’s recommendation to amend CEPA to provide express authority to request “[…] information, such as methodology data, models used etc.;” “samples of the toxicological tests and/or the other tests;” and “any other information relevant to the assessment of a substance” under section 71 of CEPA (recommendation 12) (see discussion paper 9.2). This recommendation will inform the government’s work to reform CEPA.
Section 71 provides the Minister of ECC with information gathering authorities for the purposes of “[…] assessing whether a substance is toxic or is capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control, a substance […]”. Section 46 provides the Minister of ECC with information gathering authorities for other activities such as “[…] research, creating an inventory of data, formulating objectives and codes of practice, issuing guidelines or assessing or reporting on the state of the environment […]”.
The government agrees with the committee’s recommendation that CEPA be amended to “[…] allow sections 46 and 71 notices to require that information be updated if it changes and to ensure that there are clear, consistent timeframes (e.g., 7 years) for the maintenance and retention of records related to regulations, instruments and information gathering, but also allow these timeframes to be tailored if needed, in specific circumstances” (recommendation 13) (see discussion paper 9.3) and this recommendation will inform its work to reform CEPA.
3.3.2 Information and knowledge sharing with other jurisdictions
The committee recommended that the “[…] Ministers seek out relevant and reliable data from other jurisdictions, including data from [the Registration, Evaluation, Authorisation and Restriction of Chemicals] REACH, so that Canadian assessors may benefit from other efforts deployed to conduct those assessments” (recommendation 14). The government agrees that multiple sources of data are important in the risk assessment process and commits to continuing to seek out and consider information from other jurisdictions, including the European Union, when prioritizing, assessing and managing the risks posed by chemicals and living organisms.
The government conducts systematic surveys of information from other jurisdictions both when setting priorities for risk assessments and when conducting individual assessments. It relies on multiple information sharing arrangements, including formal data sharing agreements, consideration of data from other jurisdictions, scans of international activities and datasets, discussions with multinational companies, international supply chains, and international stakeholders. The departments also use hazard characterizations undertaken by other jurisdictions, as is described in the risk assessment tool box. Approximately 700 human health effects evaluations from other organizations have provided useful inputs in substance assessments under the CMP. In situations where specific data appears to be critical in an assessment and the information is not available through other means, ECCC and HC can issue section 71 notices under CEPA to require industry to generate the necessary data.
The government has entered into a memorandum of understanding with the European Chemicals Agency (ECHA), which administers REACH. ECHA makes a summary of studies publicly available. The memorandum was signed in 2010 in order to share knowledge and exchange experience and best practices on matters of mutual interest related to chemicals management. This arrangement includes provisions for: scientific collaboration and information exchange on the risk assessment of chemicals; exchange of operational experience and strengthening regulatory capacities; active dissemination of public information and publications related to each other’s activities; and, information exchange on matters of common interest, including emerging priorities.
Under REACH, manufacturers and importers are required to submit information jointly for the same substances. Consortia are an efficient means for industry or business entities to collectively or jointly submit information under REACH. Under the Memorandum of Understanding, ECCC and HC rely on data sharing agreements to access confidential data that companies and consortia have provided to ECHA pursuant to REACH.
Canada also participates in discussions related to data sharing and risk assessment approaches with the United States through the Regulatory Cooperation Council (RCC). Examples of existing partnerships include a comparative analysis of the regulatory frameworks for the significant new activity provisions of CEPA in Canada and significant new use rule (SNUR) provisions in the United States, as well as regulatory frameworks and approaches for risk assessment. Also, the assessment collaboration framework establishes a rolling work plan which includes enhanced information sharing across the two jurisdictions.
HC has data sharing agreements in place with the European Food Safety Authority (EFSA), the United States Food and Drug Administration (USFDA), and Food Standards Australia New Zealand (FSANZ) on food-related issues that can be used to help inform CMP assessments. HC is an active participant in international assessments conducted by Codex Alimentarius and the Joint Food and Agricultural Organization/World Health Organization Expert Committee on Food Additives (JECFA).
3.4 Risk assessment
In conducting risk assessments, ECCC and HC apply a weight of evidence approach and the precautionary principle, as required by CEPA. In practice, this means that assessments consider information across multiple lines of evidence and uncertainties are captured and communicated.
Data on the amount of a substance that may enter the environment, as well as its chemical properties, provides information about how the substance may be distributed in the environment, how long it will remain in the environment and whether it is present at levels that may be harmful to Canadians or the environment. In addition, information on levels of substances in products available to Canadians and on how these products are used also informs the assessments. Different approaches for characterizing exposure may be used depending on the information available regarding sources, pathways and routes of exposure as well as uses, handling and disposal of the substance.
The potential effects of the substance on humans and the environment are evaluated through hazard characterization. Some Canadians, who, due to either greater susceptibility (such as pregnant women and children) or greater exposure (such as those Canadians living in the vicinity of an industrial facility) may be at greater risk than the general population, are specifically taken into consideration, to the extent that information is available. Information on endocrine-related effects is also considered, when available and relevant. Data generated through laboratory or field testing, modelling approaches and data from other substances that are structurally and/or functionally similar to the substance being assessed are all used, as appropriate. If the outcome of the risk assessment indicates that the substance may be harmful to human health or the environment, key sources of exposure of concern are identified along with uncertainties.
ECCC and HC use research, surveillance and monitoring to gain information about the presence or potential impact of substances on human health and the environment. This information informs both risk assessment and risk management decisions. As scientific knowledge evolves, assessment practices adapt and adjust to new information and techniques.
The list of substances on schedule 1 is available online.
3.4.1 Persistence and bioaccumulation
Persistence and bioaccumulation criteria provided a basis for the categorization process and provide the basis for the virtual elimination regime under the act.
As part of the categorization process, substances that were persistent or bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations, and inherently toxic to human beings or to non-human organisms were identified as priorities for further assessment. Information on how substances on the DSL were categorized with respect to persistence and bioaccumulation can be found online, as well as the overall results of DSL categorization.
The act further requires the “virtual elimination” of releases to the environment of toxic substances that are bioaccumulative, persistent and result primarily from human activity.
The committee made two recommendations to address persistence and bioaccumulation as these relate to risk assessment. First, the committee recommended that the government “[…] update the outdated Persistence and Bioaccumulation Regulations to be consistent with the best available science and standards, including those of other [Organisation for Economic Co-operation and Development] OECD jurisdictions” (recommendation 48) and that CEPA be amended to “[…] confirm, for greater clarity that a substance need not be persistent or bio-accumulative to be determined to be toxic under CEPA” (recommendation 49).
The government agrees with recommendation 48 and is reviewing the Persistence and Bioaccumulation Regulations.
The government agrees that a substance need not be persistent or bioaccumulative in order to be assessed as toxic and added to schedule 1. Indeed, many toxic substances that are already on schedule 1 are not persistent and bioaccumulative. For example, plastic microbeads (≤ 5 mm in size), bisphenol A, nonylphenol and its ethoxylates, and several greenhouse gases are on schedule 1 (recommendation 49).
3.4.2 Endocrine disrupting chemicals and low-dose effects
The committee made several recommendations concerning endocrine disrupting chemicals (EDCs) during its review. In particular, the committee was of the view that risk assessments under CEPA should consider endocrine disruption. The committee recommended that the government “[…] revise the definition of “toxic” to ensure that it addresses endocrine disruptors” (recommendation 39). The government supports the intent of this recommendation and is committed to considering endocrine disruption when it assesses risks from substances.
The committee also recommended “[…] that sections 64 and 68 of CEPA be amended to expressly address substances that are dangerous at low-level quantity thresholds” (recommendation 40). The government supports the intent of this recommendation and is committed to considering low-dose impacts in risk assessments. The government also commits to continuously improve its ability to assess other low-dose effects. The current definition of “toxic” in section 64 of the act is sufficiently broad to enable the departments to consider these risks and impacts. In the assessment of bisphenol A (BPA), for example, data on the impact of low doses on neurodevelopmental and behavioural effects helped support the risk characterization for human health.
In addition to managing a substance by adding it to schedule 1, CEPA provides various authorities for preventing risks from new substances that the Ministers suspect are toxic or capable of becoming toxic. The Minister of ECC has exercised these authorities by placing controls on a number of new substances suspected of endocrine disrupting effects. For example, ministerial conditions have been placed on a mixture of phthalates used as a softener for plastics to prohibit its use in toys and child care articles, and on the use of a formaldehyde remover used in fabric softeners. A significant new activity (SNAc) notice has been placed on any new use of curing agents for silicone sealants for commercial building and road construction due to concerns about endocrine disruption. SNAc notices are used to allow the activity for which a new substance has been notified but to prevent any additional uses which would, for example, increase exposure. In each of these cases, the risk management action was taken to address concerns about possible endocrine disruption impacts.
The government is working to better explain how it considers endocrine disrupting effects in risk assessments under CEPA. ECCC and HC are updating assessment reports and associated information sheets to explicitly highlight when endocrine effects have been taken into consideration and how this information informed the assessment. In the spirit of the committee’s recommendation, ECCC and HC recently published a CMP risk assessment fact sheet in June 2017 to explain how EDC-related effects are considered in risk assessments and to elaborate on EDC-related research that is underway. Published assessments that considered endocrine disrupting properties include bisphenol A, phthalates, and nonylphenol and its ethoxylates.
The committee also recommended that ECCC and HC “[…] implement measures, thresholds, techniques and reporting requirements specifically addressing endocrine disruptors” (recommendation 44). The government agrees with the importance of addressing endocrine disrupting substances, and is committed to continuously improving its ability to do so and to keep pace with the latest scientific developments. Especially important is increased susceptibility during early life stages. In fact, subsection 44(4) of CEPA requires the Ministers to conduct research on hormone disrupting substances.
The government is considering new approach methodologies, including in vitro alternative methods to detect endocrine activity at low doses. This type of method will also be useful for characterizing endocrine activity for mixtures of substances at low doses. These emerging approaches will improve priority-setting and risk assessments, and will enable a greater focus on substances with an endocrine mode of action at low doses. The government will continue to use and develop available test methods for addressing endocrine disruptors.
Canadian researchers and regulators are actively involved with the international community to advance and adapt novel approaches in the testing and consideration of endocrine-related effects in risk assessment. For example, ECCC and HC maintain active scientific research programs that contribute to the development of internationally-recognized test methods for endocrine disruption. This work contributed to an OECD publication in March 2018 (PDF, 3.1MB), and routinely informs risk assessments carried out under CEPA. The government commits to adopting OECD test methods and thresholds in Canada, where possible and as they are developed, for future risk assessments under the CMP.
Moving forward, the government will continue to improve its ability to consider endocrine disrupting effects in its risk assessments. The government will continue to keep pace with the latest scientific developments related to endocrine disruption when developing appropriate actions to prevent risks to Canadians and their environment. Opportunities to improve the assessment of the endocrine disruption properties of chemicals are being discussed by both the CMP Stakeholder Advisory Council and the CMP Science Committee in 2018. The deliberations at the Science Committee will focus on key science considerations as the government moves forward with evolving its approach to endocrine disruption as the science itself develops. Summary reports from these discussions will be posted online and the outcome of these discussions will inform ongoing improvements to risk assessments under CEPA. The government commits to further consider the committee’s recommendation as part of its stakeholder engagement on this issue through the CMP post-2020 process, which will inform how CEPA is reformed.
3.4.3 Vulnerable populations, cumulative effects and monitoring
The committee’s report placed a large focus on strengthening protections for vulnerable populations and ensuring that the cumulative impacts of certain chemicals are considered. The committee recommended that “[…] the preamble of CEPA be amended […] to mention the importance of considering vulnerable populations in risk assessments […]” (recommendation 3, sub-bullet 2). The government agrees with the committee (see discussion paper 2.1) and this recommendation will inform its work to reform CEPA. The committee also recommended amending section 3 of CEPA “[…] to include a broad definition of the term “vulnerable populations”” (recommendation 42), that CEPA be amended “[…] to require that the Ministers or their delegates, when determining if a substance is toxic, assess exposures of vulnerable populations and marginalized communities, including exposures during critical windows of vulnerability, with appropriate use of safety factors and that this section clarify that, for some substances, there may be no safe exposure thresholds” (recommendation 43), and that CEPA be amended to “[…] require investigation of the effects of any proposed or final regulation or instrument on vulnerable populations and marginalized communities […and…] aggregate exposures, and cumulative and synergistic effects, in determining how to regulate a toxic substance” (recommendation 56). The government supports the intent of these recommendations and will consider them as part of its work to reform CEPA.
The committee also recommended that ECCC “[…] undertake, in consultation with the provinces, territories, Indigenous communities and the public, an assessment of potential hot spots or areas of potential intensified or cumulative emissions of toxins to ensure protection for vulnerable persons” (recommendation 45). The CMP Stakeholder Advisory Council held a panel discussion on vulnerable populations in 2018 and provided advice on how the departments should strengthen consideration of vulnerable populations in chemicals management. The government commits to further consider the committee’s recommendations as part of its stakeholder engagement on these issues through the CMP post-2020 process, which will inform how CEPA is reformed (recommendations 3 sub-bullet 2, 42, 43, 45 and 56).
In the interim, the government will continue to consider available information on vulnerable populations when conducting risk assessments. Further, the government is committed to continuously improving the consideration of vulnerable populations in the assessment and management of chemicals. As part of this broad commitment, the government also commits to develop, engage on, and publish under CEPA a policy on vulnerable populations, which will include a definition of vulnerable populations and the objectives of the program, including the framework for how the government considers vulnerable populations as part of risk assessments.
Some Canadians, due to greater susceptibility (such as pregnant women and children) or greater exposure (such as those Canadians living in the vicinity of an industrial facility), may be at greater risk than the general population. The CMP routinely considers these risks both in conducting risk assessments and in designing risk management measures. This includes specific consideration of the developing fetus, infants, children, pregnant women, individuals living in the vicinity of industrial or commercial facilities, and First Nations and Inuit populations (recommendation 43). Where assessments identify risks in specific populations, targeted risk management approaches are developed to reduce the risks for that group (recommendation 56).
For example, the risk assessment of bisphenol A (BPA) identified potential for exposure for infants. The outcome of the assessment resulted in a Code of Practice to reduce levels of BPA in infant formula can linings. Since that time, Health Canada has conducted a number of additional surveys to measure the concentrations of BPA in canned drink products, bottled water products, canned food products, soft drink and beer products, and total diet samples.
In the case of selenium, the risk assessment identified the potential for elevated selenium exposure to three populations: Inuit populations; subsistence fishers; and Canadians taking certain multi-vitamin/mineral supplements.
The government recently published CMP risk assessment fact sheets explaining how precaution is applied and how human biomonitoring data are used in risk assessments. When information is limited, risk assessors under CEPA apply conservative assumptions to ensure protection of human health, including the health of vulnerable populations. In accordance with precautionary assessment protocols, assessors may apply additional safety factors or make “worst case” assumptions regarding exposure.
HC is the lead on the CMP’s public outreach program, which is used to educate Canadians on how to protect themselves from harmful chemicals. This includes environmental health guides, partnerships and other activities geared towards reaching parents and caregivers of young children and seniors. Strengthening this program to enable it to reach a broader range of vulnerable populations will be a focus of a new strategy for the public outreach program that is currently under development.
The committee emphasized the importance of biomonitoring and environmental monitoring as an important source of information, particularly with respect to vulnerable populations and geographic “hot spots.” The government agrees with the committee that biomonitoring data are an important source of information on levels of exposure to vulnerable populations, as well as on combined exposures to multiple chemicals, and we are placing a high priority on monitoring. The government also commits to continuously improve biomonitoring in support of protecting vulnerable populations (recommendation 45).
For instance, the government is committed to continuing to use and improve sources such as the Canadian Health Measures Survey (CHMS), the Maternal-Infant Research on Environmental Chemicals (MIREC) Research Platform and the First Nations Biomonitoring Initiative (FNBI) and Northern Contaminants Program (NCP). In the spirit of the committee’s recommendations, in December 2017 the government signed a memorandum of understanding with the Government of Alberta formalizing responsibilities to continue a long-term environmental monitoring program in the Athabasca River basin region, and to include greater Indigenous involvement in establishing monitoring priorities. This will improve understanding of the long-term cumulative effects of oil sands development. More information concerning the government’s response to the committee’s recommendations regarding ‘hot spots’ can be found in the section “Response to addition to schedule 1” later in Chapter 3 and the section on “Hot spots” in Chapter 4 of this report.
With respect to exposure to multiple chemicals (cumulative risk) the government supports the intent of the committee’s recommendation to amend CEPA “[…] by adding a new requirement that the Ministers or their delegates, when determining if a substance is toxic, assess aggregate exposure to and cumulative and synergistic effects of the substance, and that the Ministers use a process that looks at multiple exposure points of a chemical substance” (recommendation 46). The government supports the intent of this recommendation and will consider it as part of its work to reform CEPA. The government also commits to reviewing best practices regarding cumulative risk internationally.
The government recognizes the benefit of better assessing the risks from real-life exposures to a range of chemicals and acknowledges the complexity of the issue. ECCC and HC sought advice on cumulative risk assessment from the CMP Science Committee in 2015 and are also co-leading the finalization of an OECD guidance document on the considerations for assessment of the risks of combined exposure to multiple chemicals. This Guidance Document will inform risk assessments under CEPA moving forward.
In the interim, the government will also continue to examine emerging data and novel approaches for consideration in cumulative risk assessment, further contributing to world-leading science and methodologies. It will also continue to carry out cumulative risk assessments for substance groupings where sufficient data and information exists, as was done for the phthalates grouping and for several metal moieties. The government recognizes the benefit of better assessing the risks from real-life exposures to a range of chemicals. However, there is a need for more robust data sets in order to determine when cumulative risk assessments would be important to health protection, such as more comprehensive monitoring from multiple sources of exposure (e.g., collect air, house dust, and tap water monitoring data in the same study).
As part of the CMP post-2020 process, ECCC and HC are considering issues related to cumulative risk. At the November 2017 multi-stakeholder workshop, ECCC and HC presented relevant experience and considerations on cumulative approaches and participated in a facilitated discussion with stakeholders on some of the key challenges, opportunities and roles the government could play in addressing these challenges (Recommendations 45, 46 and 56). The government also commits to further consider the committee’s recommendations as part of its stakeholder engagement on this issue through the CMP post-2020 process, which will inform how CEPA is reformed.
Finally, it is important to note that biomonitoring data are an important source of information on levels of exposure to vulnerable populations, as well as on combined exposures to multiple chemicals. For example, as discussed above, the Canadian Health Measures Survey (CHMS) has been collecting nationally representative biomonitoring data in the general population since 2007. The CHMS currently covers people aged 3 to 79 years old and is expanding the populations covered under the biomonitoring component to include 1-2 year olds by 2020. The Maternal-Infant Research on Environmental Chemicals (MIREC) Research Platform has been used to collect data on pregnant women and children. The First Nations Biomonitoring Initiative (FNBI) and Northern Contaminants Program (NCP) funded research to provide biomonitoring data for First Nations and Inuit populations in Canada. More information on how human biomonitoring data are used in risk assessments is available as part of the CMP risk assessment fact sheet series.
The government believes that effective biomonitoring is fundamental to helping address the Committee’s concerns related to vulnerable populations and combined exposures (Recommendations 3, sub-bullet 2, 42, 43, 45, 46, and 56). The government recognizes that current biomonitoring surveys only measure a small proportion of the chemicals in commerce and it is currently examining new methods that can detect a much broader range of substances, as well as methods that can detect substances at lower levels and in smaller volumes of biological matrices (e.g., blood, urine). These developments will be important to priority-setting in chemicals management moving forward. In addition, the government also recognizes that there are certain populations not adequately captured by the government’s current biomonitoring programs, such as First Nations populations living in the Yukon and the Northwest Territories, people living near contaminated sites, and new immigrants. The government is considering developing smaller, more targeted biomonitoring studies to help address these data gaps.
ECCC and HC also use other types of data from studies that measure levels of chemicals in environmental media and food, such as Health Canada’s total diet study, which has been collecting data since 1969. In addition, since 2008, the government has been supporting the First Nations food, nutrition and environment study, a 10-year baseline study to determine dietary intake (both traditional and market foods), food security status, and environmental contaminant exposure of First Nations living on reserve across Canada. Data from these studies can also be used to inform exposure levels of vulnerable populations to certain chemicals.
ECCC conducts national monitoring on priority chemicals in air, water, sediment, fish, wildlife, and sources such as wastewater treatment plant effluents and sludge. Information from environmental monitoring has informed assessments involving aggregate exposure from multiple sources (e.g. metals). The government is currently considering how environmental monitoring work can be used to further inform the identification of cumulative risks moving forward.
3.4.4 Identifying new priorities for assessment
Since 2006, priorities for risk assessment of chemicals and other substances under CEPA have largely been based on the results of the DSL categorization process and new substance notifications. The categorization exercise used criteria for persistence, bioaccumulation, inherent toxicity and greatest potential for human exposure. However, our knowledge of chemicals and priority-setting continues to evolve and ECCC and HC have expanded their consideration of hazard and exposure characteristics, using a risk-based approach to identify substances that may have the potential to cause harm to the environment or human health. Under the identification of risk assessment priorities (IRAP), ECCC and HC also identify priorities through other “feeders” such as international activities, data-gathering and research. For example, plastic microbeads, perfluorinated substances, flame retardants, and parabens were all added to the CMP assessment work plan even though they did not meet the categorization criteria. The IRAP approach is presented in the publication “Approach for identification of chemicals and polymers as risk assessment priorities under Part 5 of the Canadian Environmental Protection Act, 1999”.
The committee recommended amending CEPA to require an assessment or reassessment of a substance “[…] when another OECD country has placed new restrictions on it, or when the use of the substance in Canada has significantly expanded since the original assessment was completed, or when new scientific findings respecting the substance’s toxicity come to the attention of the Minister” (recommendation 50). The government supports the intent of this recommendation and commits to the full implementation of section 75 of CEPA, which requires the review of decisions of other jurisdictions. The government also commits to further consider the committee’s recommendation as part of its stakeholder engagement on this issue through the CMP post-2020 process, which will inform how CEPA is reformed.
In the interim, the government will continue to prioritize ongoing risk assessment activity in accordance with its IRAP approach, which requires the systematic compilation and review of information from a large number of information sources and enables the government to be better positioned to recognize concerns, to track emerging issues, and to identify and prioritize substances requiring further work. This also helps to increase the transparency of the process for identifying new priorities.
In order to facilitate access to information regarding assessment and reassessment priorities, the government commits to include the results of the IRAP process in the annual CEPA report to parliament.
Further information on the IRAP process, including results from the 2015 and 2016 prioritization exercises, is outlined in a CMP risk assessment fact sheet published in June 2017 on the "identification of risk assessment priorities”.
3.5 Risk management
Risks to the environment and human health are identified through the risk assessment process. Once it has been determined that a chemical substance poses a risk to human health or the environment, ECCC and HC risk managers determine how best to prevent that risk. To do this, risk managers must understand how the chemical substance is created, who uses it, and how it reaches the environment or people.
If a risk management instrument has been in place for some time and the government is not satisfied that the risk has been sufficiently prevented or reduced, it can take further action.
There are various authorities and requirements under CEPA with respect to managing the risks posed by substances, including those that are found "toxic" under CEPA according to the criteria in section 64. For toxic substances that are recommended for addition to schedule 1 of the act under paragraph 77(6)(b), ECCC must propose a regulation or instrument respecting preventive or control actions to risk manage the toxic substance. The government can also use risk management instruments under other Acts such as the Canada Consumer Product Safety Act (CCPSA), the Pest Control Products Act (PCPA), and the Food and Drugs Act (F&DA). When making risk management decisions, consideration is given to which statute is best placed to manage the identified risks.
A summary list of the risk management instruments developed to manage substances that have been assessed under CEPA to be harmful to the environment or human health is available online. Further assessment and management-related information on toxic substances listed on schedule 1 is available on the CEPA Registry.
3.5.1 Response to addition to schedule 1
To identify the best suited risk management instruments (binding or non-binding), risk managers follow a systematic approach. Through the instrument choice process, risk managers identify which instrument or mix of instruments is best suited to help achieve the risk management objectives. The process takes into consideration the effectiveness and efficiency of various risk management instruments, available information on the chemical substance and its sources of risk, and guidance such as the Government of Canada's Cabinet Directive on regulatory management).
Consulting with interested and implicated stakeholders helps inform the choice and design of risk management instruments. Information on issues for which public input is sought is available in the CMP's two year rolling risk management activities and consultations schedule.
ECCC and HC measure the performance of these instruments by evaluating the ongoing relevance and effectiveness of the actions taken to manage risks from toxic substances. Substance-based performance measurement considers the performance of all final risk management instruments applied to a chemical substance and relevant data or indicators of exposure to the environment or human health. Instrument-based performance measurement evaluates the effectiveness of an individual instrument in meeting the specific risk management objectives for the instrument. The results of performance measurement help determine if additional risk management or assessment is needed.
The committee made several recommendations concerning the response to listing a substance on Schedule 1. It recommended amending CEPA to “[…] update, improve and prescribe timelines for all actions under CEPA, such as for listing a substance on Schedule 1 after the conclusion of a screening assessment; for producing draft measures to address all risks from newly listed substances and for finalizing those measures” (recommendation 54). The government commits to further consider the committee’s recommendation as part of its stakeholder engagement on this issue through the CMP post-2020 process, which will inform how CEPA is reformed.
The committee also recommended that CEPA be amended, “[…] to require mandatory monitoring of listed toxic substances” and “[…] to require publication every five years of a comprehensive state of the environment report and that such a report incorporate specific environmental justice reporting on exposure levels in hot spots and assessments of health inequality” (recommendations 21 and 23). The government recognizes the committee’s concern, and supports the intent of recommendation 21. The government commits to continue delivering its programs for environmental monitoring and biomonitoring; these are important functions in ensuring the ongoing effectiveness and continuous improvement of chemicals management. For instance, human biomonitoring data are used in risk assessments.
In addition, the Canada-Alberta Oil Sands Monitoring Program illustrates how the government is committed to provide comprehensive environmental monitoring data and information to improve understanding of the long-term cumulative effects of oil sands development. The two governments have been actively monitoring water quality, air quality and biodiversity in the Athabasca River basin since 2012. In the spirit of the committee’s recommendation, the two governments signed a memorandum of understanding in 2017 formalizing their shared responsibility to continue a long-term environmental monitoring program in the region, and to include greater Indigenous involvement in establishing monitoring priorities. Data from the program are publically available on the Oil Sands Information Portal. For example, for water quality, data are available for 17 sites in the lower Athabasca River, as well as for the Peace and Slave rivers, and their tributaries, and include measurements of major ions, nutrients, metals (dissolved and total) and organics (including BTEX, cyanide and polycyclic aromatic hydrocarbons (PAHs).
With respect to recommendation 23, the Canadian Environmental Sustainability Indicators (CESI) program provides data and information to track Canada's performance on key environmental sustainability issues including climate change and air quality, water quality and availability, and protecting nature. CESI is the primary instrument to measure progress of the Federal Sustainable Development Strategy (FSDS) and responds to ECCC’s legal obligations under CEPA and the Department of the Environment Act to report to Canadians on the state of the environment.
While implementation of this recommendation would duplicate many of the actions underway with respect to CESI and the FSDS, the government commits to further consider the committee’s related recommendations on vulnerable populations, cumulative effects and hot spots as part of its stakeholder engagement through the CMP post-2020 process, which will inform how CEPA is reformed.
3.5.2 Virtual elimination of persistent, bioaccumulative and toxic substances and reverse burden for substances of very high concern
For substances assessed as "toxic" according to the criteria in section 64 and recommended for addition to Schedule 1 pursuant to paragraph 77(6)(b), ECCC must propose an instrument to establish preventive or control actions for managing the substance with the objective of reducing or eliminating risks to human health and the environment posed by its use or release.
For most toxic substances, the act provides strict timelines to develop a risk management instrument but provides broad discretion as to the type of instrument and the risk management goal. However, for toxic substances that are also bioaccumulative and persistent (PBTs), the act also requires the Ministers to "implement virtual elimination” by: specifying a level of quantification (LOQ) that is, the lowest concentration of a toxic substance that can be accurately measured using sensitive but routine sampling and analytical methods; adding the substance and its LOQ to the virtual elimination list; and, identifying the quantity or concentration of the substance that may be released into the environment in “release limit” regulations.
While the government aims to achieve the risk management objective of virtually eliminating releases to the environment of PBTs, it is not always possible or practicable for the Ministers to meet all the statutory obligations associated with virtual elimination, such as specifying a LOQ or promulgating release limit regulations. The committee acknowledged the practical challenges, and recommended that ECCC “[…] revisit the virtual elimination regime and implement a more effective regime” (recommendation 61). The government agrees with the committee (see discussion paper 2.8) and this recommendation will inform its work to reform CEPA. The government also commits to further consider the committee’s recommendation as part of its stakeholder engagement on this issue through the CMP post-2020 process, which will inform how CEPA is reformed.
The committee also considered how best to identify and manage substances of very high concern (SVHCs). The committee recommended that Part 5 of CEPA be amended to “[…] require a reverse-burden approach for a subset of substances that are of very high concern, including carcinogenic, mutagenic, and toxic to reproduction; very persistent and very bioaccumulative; and persistent, bioaccumulative and toxic. Substances in any of these categories should be prohibited unless industry can provide the government with adequate certainty that the substances can be used or emitted safely in specific applications and that there are no feasible substitutes”(recommendation 41). CEPA provides broad authority, including an extensive suite of risk management tools, to manage the risks posed by substances with these characteristics. The government recognizes the committee’s concern and commits to further consider the committee’s recommendation as part of its stakeholder engagement on this issue through the CMP post-2020 process, which will inform how CEPA is reformed.
3.5.3 Life-cycle management
Toxic substances that are not subject to virtual elimination are managed using a life-cycle approach. A number of risk management tools may be used to control various aspects of the life-cycle of a toxic substance from the design and development stage to its manufacture, use, handling, storage, import, export, transport and ultimate disposal.
The committee recommended “[…] that Environment and Climate Change Canada and Health Canada adopt a life-cycle approach to assessing and managing substances under CEPA” (recommendation 47). The government agrees and is committed to incorporating life-cycle analysis in risk management decision-making. Life-cycle analysis is fundamental in terms of how the departments consider exposure and risk. It also informs the instrument selection process, by examining where in the life-cycle (during manufacturing, use or after disposal) risk management is best focused. For example, in the case of mercury, various risk management instruments are in place which target different points in the substance’s life-cycle including industrial releases, products, and waste.
3.5.4 Informed substitution
The committee’s report emphasized promoting the use of safer alternatives to substances on schedule 1 (informed substitution), and avoiding situations where a substance on schedule 1 is replaced with an equally if not more toxic substance (regrettable substitution). The committee recommended amending CEPA to “[…] add a mandatory duty to assess alternatives as part of all screening assessments of existing substances” (recommendation 57), to “[…] add a mandatory substitution test to the regulation of substances under Part 5 […]” (recommendation 58), and to make changes to ensure alternative assessments include “[…] consideration of the opportunities, costs and feasibility of adopting and implementing safer alternatives, clear recommendations for the elimination, or limited use of a toxic substance, efforts to ensure transparency across the supply chain regarding key information and the process to be used in the development of alternative assessments; and review of data on a consistent basis […]” (recommendation 59). Finally, the committee also recommended that CEPA be amended to “[…] mandate that the Minister prepare national safer alternatives action plans for substances for which reports on safer alternatives have been prepared” (recommendation 60).
The government recognizes the concerns of the committee, and supports the intent of Recommendations 57-60. This is an emerging area internationally. Where possible, ECCC and HC assess substances with similar usage patterns or chemical properties as a group. Recent examples include substituted diphenylamines (SDPA) and flame retardants. When ECCC develops or amends regulations with the intent of restricting or prohibiting toxic substances, the department takes into account the availability of economically and technically feasible chemical and non-chemical alternatives. When no economically and technically feasible alternatives are available, a phase out period to allow industry to find and transition to alternatives may be considered.
Canada is committed to collaborating with other jurisdictions to ensure that international experience helps inform the government’s emerging approach to alternatives assessment and informed substitution. The government further commits to reviewing best practices regarding informed substitution internationally.
This government is also considering new ways, including consulting with experts and stakeholders, to support informed substitution. ECCC commissioned a study to identify international best practices and options for Canada and commits to publish the results of this work. ECCC and HC also engaged the CMP Stakeholder Advisory committee in 2017 and the Science committee in January 2018 on informed substitution. The government commits to further consider the committee’s recommendations as part of its stakeholder engagement on this issue through the CMP post-2020 process, which will inform how CEPA is reformed.
3.6.1 Electromagnetic radiation
The committee recommended that HC and ECCC “[…] conduct studies on the effects of electromagnetic radiation on biota, review the adequacy of the current guidelines provided in Safety Code 6 and report their findings back to the committee” (recommendation 62). HC has determined that exposure to radiofrequency electromagnetic energy below the levels in Safety Code 6 is not dangerous to the public and the government has determined that no further updates to Safety Code 6 are required at this time. ECCC is reviewing the scientific evidence provided to the committee on the effects of electromagnetic radiation on biota.
HC developed and maintains Safety Code 6, a radiofrequency exposure guideline formally entitled "limits of human exposure to radiofrequency electromagnetic fields in the frequency range 3kHz to 300 GHz”.
Safety Code 6 was updated in 2015 to take into account recent scientific data from studies carried out worldwide. This update, which included more restrictive radiofrequency (RF) exposure limits than the previous version of the Code, was reviewed by an Expert Panel of the Royal Society of Canada (RSC). The RSC concluded that there are no established adverse human health effects at exposure levels below the limits proposed. Safety Code 6 was also recently reviewed by the House of Commons Standing committee on Health and no changes were recommended. HC will continue to monitor the scientific literature on exposures to radiofrequency electromagnetic energy.
As part of its mandate, HC monitors the scientific literature and has conducted its own research on the human health effects of radiofrequency electromagnetic energy. This research has increased the scientific knowledge regarding the intensity of radiofrequency energy in our environment and the possible biological / health effects of radiofrequency energy, and has helped to establish the human exposure threshold where potentially adverse health effects may occur. This important information, along with other Canadian and international studies, forms the basis for establishing safety standards for radiofrequency energy that protects the health of Canadians. Information on research in this area is available on the HC website.
3.6.2 Best placed act
The committee made recommendations regarding which Minister should be responsible, or under which Act should fall the responsibility, for managing substances on schedule 1. The committee recommended that CEPA be “[…] the principal statute for regulating products containing toxic substances” (recommendation 10). The government agrees that CEPA is the principal statute for regulating toxic substances (see discussion paper 2.9).
While the government protects health and the environment using numerous laws that govern chemical substances, including those in food, drugs, pesticides and various types of products, CEPA is the foundational legal authority that ensures that all new substances are assessed for their potential to harm human health or the environment before their entry into the Canadian marketplace. However, to avoid regulatory duplication, CEPA does not apply in circumstances where another federal law provides for an equivalent pre-market assessment of both health and environmental risks. These acts and regulations are listed in Schedule 2 (new chemicals or polymers) and Schedule 4 (new animate products of biotechnology) of CEPA.
CEPA is also the key authority for managing the risks associated with existing substances. However, the government also has access to risk management tools outside of CEPA that can address toxic or other chemical substances. Actions can be taken under other Acts, such as the Canada Consumer Product Safety Act, the Pest Control Products Act, and the Food and Drugs Act. When making risk management decisions, consideration is given to which Act is best placed, or which federal department has the best tools and expertise to manage the identified risks.
The government explains all risk management decisions and has published a summary list of risk management instruments for substances that are concluded as toxic under section 64 of CEPA.
The government agrees with the committee’s recommendation that CEPA be amended to “[…] formally allow the Minister of Health to be the lead in developing and recommending instruments and regulations under CEPA for a toxic substance in circumstances where the risks posed by the toxic substance are health related” (recommendation 11) (see discussion paper 2.10) and this recommendation will inform its work to reform CEPA.
3.6.3 Environmental performance agreements
The committee recommended that CEPA be amended to “[…] expressly allow performance agreements between either the Minister of Health or the Minister of Environment and Climate Change and another party, to fulfill the risk management obligation, subject to specific criteria, third party oversight and public notice” (recommendation 84). The government agrees with the committee (see discussion paper 2.9, first bullet) and this recommendation will inform its work to reform CEPA.
More information respecting environmental performance agreements is available online.
3.6.4 The process for addition to schedule 1
A substance that is found to be "toxic" under section 64 of CEPA, through a priority substances list assessment of the substance, a screening assessment, or the review of a decision by another jurisdiction, is recommended for addition to schedule 1 of CEPA, with the exception of those substances included on the non-statutory list.
The committee recommended “[…] that substances be added to the list of toxic substances automatically upon a finding of toxicity by the Ministers of Health and Environment and Climate Change” (recommendation 52). The government acknowledges the committee’s concern, but does not support this recommendation at this time. If implemented, this recommendation would result in less transparency and public participation at an important point in government decision-making than is currently provided. The current Act allows for stakeholders to provide comments, issue a notice of objection, or request a board of review regarding these decisions.
In some cases, substances are added to schedule 1 of CEPA through section 90(1) of the act (i.e., without having undergone a priority substances list assessment, a screening assessment, or a review of another jurisdiction's decision) if, on the recommendation of the Ministers, the Governor in Council is satisfied that a substance is toxic under section 64. This provides for an expedited route for addition to schedule 1 if the circumstances warrant it.
3.6.5 Maintaining the domestic substances list
The government agrees with the committee’s recommendation that CEPA be amended to “[…] add an explicit authority to remove a substance from the domestic substances list when it is not in commerce […]” and that “removal should involve a transparent process with opportunity for public comment” (recommendation 53) (see discussion paper 2.2). This recommendation will inform the government’s work to reform CEPA. The committee also recommended that CEPA be amended to “[…] require every person who transfers a substance or living organism that is subject to a significant new activity notice and that is on the domestic substances list to notify all persons to whom the substance or living organism is transferred of an obligation to comply with the significant new activity notice” (recommendation 51). The government agrees with the committee (see discussion paper 2.7) and this recommendation will inform its work to reform CEPA.
3.6.6 Animate products of biotechnology
Part 6 of the act applies to “animate products of biotechnology”, where biotechnology is defined as “the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms.” The New Substances Notification Regulations (Organisms) establish classes or groups of organisms, including micro-organisms as well as “higher” organisms such as fish, livestock and insects (depending on the type of use). In the case of fish, ECCC has agreements with other federal departments to conduct assessments.
The committee made recommendations regarding animate products of biotechnology, including to amend part 6 of the act, “[…] to provide clear rules on how and under what circumstances the right to introduce a new substance or organism is transferable […]” (recommendation 63, sub-bullet 1), “[…] to provide clear rules on the approval process for new uses by the party introducing the substance or organism and by others they may sell the substance to […]” (recommendation 63, sub-bullet 2), and, “[…] to change the name of part 6 from animate products of biotechnology to a term more widely used such as genetically engineered or modified organisms” (recommendation 63, sub-bullet 3).
Subsection 106(5) of CEPA addresses transfers of a living organism to persons other than the person who submitted the notification to the government. The government agrees with the intent of recommendation 63, sub-bullet 1. In response to the committee’s call for greater clarity, ECCC is working to make additional guidance available on transfer of substances, products and intellectual property.
Existing guidance is described in the government’s advisory note on new substances. This guidance is being revised to provide clearer direction. Special attention will be paid to the elements highlighted in the committee’s recommendations.
The government agrees with the intent of recommendation 63, sub-bullet 2, and ECCC and HC are developing additional guidance on the assessment and approvals processes to improve clarity in response to this recommendation.
The current guidance is described in the new substances guidelines for organisms. ECCC and HC are revising this guidance to provide clearer direction. Special attention will be paid to the elements highlighted in the committee’s recommendations.
With respect to recommendation 63, sub-bullet 3, the government acknowledges the committee’s concern, but does not support this particular recommendation at this time. As explained above, part 6 of the act applies to animate products of “biotechnology”, which is in turn defined as “the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms.” Since part 6 applies to both living organisms in their “natural or modified forms”, it could be misleading or cause confusion if the title of the part was changed to “genetically engineered or modified organisms.”
Finally, the committee recommended that “[…] the Minister of Environment and Climate Change lead a process involving other relevant federal departments and including meaningful public consultation to put in place an effective and transparent regulatory regime for genetically modified organisms” (recommendation 64). The government supports the intent of this recommendation, and ECCC is working with other federal departments and agencies to address these issues through administrative changes.
For example, a recent initiative to increase transparency regarding new substances involves a voluntary process whereby a summary of new notifications on higher organisms is published for a “public comment” period early in the assessment process. The public comment period would solicit public submissions of scientific information to inform the risk assessment (see response to recommendations 25 and 26 in chapter 5).
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