PACP Committee Report
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Government Response to the Report of the Standing Committee On Public Accounts entitled Chapter 2, “Risks of Toxic Substances,” of the Fall 2009 Report of The Commissioner of the Environment and Sustainable Development The Government of Canada has carefully considered the Report of the Standing Committee on Public Accounts (the Committee) entitled Chapter 2, “Risks of Toxic Substances,” of the Fall 2009 Report of the Commissioner of the Environment and Sustainable Development. The Government would like to thank the members of the Committee for their work in preparing this report and welcomes their interest in the important work of protecting Canadians and the environment through the assessment and management of risks posed by harmful substances. Below is the Government’s Response to the Committee’s recommendations. Committee Recommendation 1 The Committee asks that Environment Canada (EC) and Health Canada (HC) provide a status report by January 31, 2011 on their progress in addressing the recommendations of the Commissioner of Environment and Sustainable Development (CESD) and that the departments continue to provide annual status reports until all of the Commissioner’s recommendations have been addressed. Government Response: The Government agrees with this recommendation. Below are status reports on each of the three CESD recommendations. Future status reports on this Standing Committee recommendation will be available, as appropriate, through reporting documents such as updates to the CESD, in the Canadian Environmental Protection Act, 1999 (CEPA 1999) Annual Reports and in the departments’ Departmental Performance Reports (DPR). CESD Recommendation 1: EC and HC should prepare and implement risk management strategies for lead and mercury which provide a comprehensive and consolidated picture of Government achievements to date and include overarching risk management objectives, priorities, timelines and monitoring to address the ongoing human health and the environmental risks associated with these substances. Status: The departments have, for many years, taken significant actions to protect the environment and the health of Canadians from lead and mercury. In recognition of the harmful effects of lead to human health and environment, the Government of Canada has taken significant action since the 1970s to reduce the risks associated with exposure to lead. Existing risk management for lead is extensive, and includes action under various statutes and regulations, including CEPA 1999, the Hazardous Products Act, and the Food and Drugs Act. In response to growing international recognition that the effects of lead are broader than previously understood, HC initiated a comprehensive reassessment of lead. The reassessment, which is based on the latest science, affords the opportunity to review existing risk management actions to ensure that they continue to contribute to reducing Canadians’ exposure to the harmful effects of lead, as well as to identify new risk management measures. The Government of Canada will publish a comprehensive risk management strategy for lead in the spring of 2011, to coincide with the release of the reassessment. Both documents will be available for public comment through the Chemical Substances website www.chemicalsubstanceschimiques.gc.ca. In keeping with other risk management documents prepared under the CMP, the risk management strategy for lead will provide a consolidated view on the actions already in place under CEPA 1999 and other statutes, as well as actions under consideration. It will also outline clear objectives, performance expectations, and timelines so that risk management can be monitored, evaluated, reported on and adjusted as appropriate. Canada’s first integrated risk management strategy for mercury, a comprehensive compilation of Government of Canada actions and achievements on the overall management of mercury, was released in October 2010. The strategy outlines domestic and international actions to reduce the risks associated with mercury, discusses additional actions under consideration and provides information on the status of initiatives to reduce global emissions. Risk management strategies are updated using new science to address current risks according to their relative priority in protecting human health and the environment. The risk management strategy for mercury is available at www.ec.gc.ca/doc/mercure-mercury/1241/index_e.htm. CESD Recommendation 2: EC should release the CEPA 1999 annual report in a timely manner. In these reports, EC should present a complete and transparent picture of its previous year’s compliance promotion and enforcement activities and related results, including compliance rates. Status: The CEPA 1999 Annual Report covers actions and accomplishments within the scope of the Act, including research, enforcement, administration and progress on issues such as the management of chemical substances. Most of these activities are also reported on the CEPA Environmental Registry, which is maintained daily as required. The 2008-2009 Report was tabled on May 14, 2010 and the 2009-2010 Annual Report is scheduled to be tabled in December 2010. EC has put in place staff dedicated to legislative reporting and developed a critical path to help ensure the timeliness of future reports. Compliance promotion and enforcement activities will continue to be an integral part of CEPA 1999 Annual Reports. EC’s Enforcement Branch has initiated work on the methodology for determining compliance rates and conducted preliminary research on the statistical aspects of the methodology. The Enforcement Branch has also collected information on best practices at the national and international level. The Branch is currently preparing a feasibility study on developing compliance rate statistics. EC will continue its work on determining compliance rates for inclusion in future annual reports. CESD Recommendation 3: EC and HC should ensure that the implementation of risk management strategies should be periodically assessed, documented and reviewed by senior management. Specific criteria should be put in place to prompt earlier assessments if warranted by new information. Status: As of 2008, the Government of Canada requires performance frameworks for all high-impact regulations. Performance Measurement and Evaluation Plans (PMEPs) are being implemented for all new high impact regulations as per the Cabinet Directive on Streamlining Regulation. Since then, EC has developed PMEPs for four regulations and three more are under development. In addition, an EC/HC working group is developing a framework to guide the application of performance measurement principles to risk management strategies. The departments are currently identifying substances on which to test and further refine the framework. Committee Recommendation 2:
That HC develop a plan to identify the risks posed by long-term, low-dose exposure to toxic substances, take action to address these risks, and report back to the Committee by 31 March 2011. Government Response The Government of Canada already addresses long-term, low-dose exposure to potentially harmful substances both in its regulatory programs and in its monitoring and surveillance and research activities. Longstanding HC approaches are aligned with other regulatory jurisdictions internationally, and the department has been a strong contributor to international initiatives in this area through its involvement in fora such as the International Programme on Chemical Safety Harmonization Project and the OECD High Production Volume Chemicals Programme. For instance, consistent with the HC Decision-Making Framework for Identifying, Assessing, and Managing Health Risks, HC takes into consideration both exposure (including long-term exposure to low levels of a substance, as warranted) and potential health effects (including effects observed at low doses in tests with laboratory animals) when characterizing potential risk to human health. When available, results from human studies also play an integral role in determining the long-term safety of chemicals. The assessment of potential risk to human health associated with long-term exposure to substances and products regulated by HC has been a key element of risk assessment activities conducted by the department under the authority of Federal statutes including CEPA 1999, the Food and Drugs Act, and the Pest Control Products Act. Human health risk assessments conducted by HC routinely take into consideration potential health effects resulting from both acute (short-term exposure to high doses) and chronic (long-term exposure to lower doses) exposures and include consideration of laboratory animal studies conducted using dose levels that can span several orders of magnitude (i.e., low- to high-dose ranges). All information across all dose levels is taken into consideration in determining health effects and in characterizing potential risk to human health. For example, effects observed in laboratory animals administered bisphenol A (BPA) at low doses informed the risk characterization in the assessment conducted under CEPA 1999. A summary of Government of Canada action on BPA can be found at: www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-2/bisphenol-a/bpa-risk_hazard-eng.php. HC monitoring programs are in place to quantify levels of selected substances in environmental media (e.g., drinking water, house dust) and food, to inform its assessments of exposures to low levels of substances. Additionally, results from biomonitoring programs, such as the Canadian Health Measures Survey (CHMS), Maternal-Infant Research on Environmental Chemicals (MIREC) study, and First Nations biomonitoring initiative referred to in the Standing Committee’s report, provide important data on actual levels in Canadians of substances to which they are exposed. As noted above, the characterization of risk to human health involves consideration of both exposure and health effects. Ongoing monitoring initiatives provide important information pertaining to chronic exposures. In order to identify the risks posed by chronic exposures, it is equally important to build on our understanding of health effects associated with real-world exposures Increasingly, emphasis is being placed on designing health effects studies in a manner that encompasses real-world exposures of Canadians. For instance, HC scientists are participating in a multi-centre study based at McGill University designed to characterize potential long-term health impacts of actual real-world exposures to chemical mixtures. Other HC scientists are studying the potential long-term health implications of early-life exposures to complex mixtures of chemicals in the environment at the actual exposure levels of individuals living in the Canadian Arctic. HC scientists are also examining the potential health impacts of ambient or point source air pollution on health outcomes such as cardiovascular health and genetic effects on the male reproductive system. The MIREC study is designed to both characterize actual exposures of pregnant Canadian women and their foetuses to selected substances and any corresponding health effects during foetal development and potentially beyond. Results from these monitoring and surveillance initiatives will inform scientific-decision making on potentially harmful substances. HC is also actively engaged in research to support refinements to risk assessment approaches. For example, HC scientists are principal research investigators in large-scale research programs in the emerging field of toxicogenomics. Measuring gene expression responses of tissue or cells exposed to a potentially harmful substance can provide insight on the potential for low level, real-world exposure to activate a molecular pathway linked to an adverse health outcome. HC is collaborating closely with the United States Environmental Protection Agency on an ambitious toxicogenomics initiative (ToxCast) which targets establishment of rapid molecular- and cell-based assays to inform prioritization and assessment of large inventories of substances. This methodology will be translated into departmental risk assessment approaches once sufficiently developed. The Chemical Substances website has information, such as links to Screening Assessment Reports and public summaries of substances under CEPA, which describes the factors taken into account in reaching assessment conclusions (www.chemicalsubstanceschimiques.gc.ca). In summary, identifying and addressing potential health risks from long-term, low-dose exposures to chemicals is already a key element of HC’s regulatory programs and its monitoring, surveillance and research activities. This work is an important component of the CMP. The scientific understanding of chronic, low-dose exposure is evolving, and science in this area must serve as the foundation for accurately identifying potential health risks and taking appropriate measures to promote and protect the health of Canadians. The Government is therefore not in a position to act on the Committee’s recommendation for a plan identifying and addressing risks from long-term, low-dose exposure to all toxic substances, by March 31, 2011. Committee Recommendation 3:
That EC’s annual performance reports include an update on the status of the negotiations regarding mercury under the United Nations Environment Programme (UNEP) and the nature of the proposed treaty. Government Response Canada is a leader in addressing mercury emissions having made domestic reductions of over 90% in the last thirty years. Canadian mercury emissions represent only 0.4% of global anthropogenic sources. However, Canada recognizes the importance of international action given that 95% of anthropogenic emissions reaching Canada come from foreign sources. As such, in 2009, Canada was supportive when the UNEP Governing Council agreed to negotiate a treaty to address mercury supply, trade, demand in products and processes, atmospheric emissions, mercury-containing wastes, contaminated sites, long-term storage, scientific information exchange and arrangements for financial assistance and capacity building. The Government notes that the second of five negotiating sessions toward developing a global legally binding instrument on mercury under UNEP will be held in January 2011. The negotiations are expected to be completed in 2013. An update on the status of these negotiating sessions will be included in the CEPA 1999 Annual Reports and EC’s DPR. Committee Recommendation 4: That EC implements regulations on the control of the manufacture, import and sale of products containing mercury by June 30, 2011. Government Response The Government of Canada is working diligently to develop regulations on the control of the manufacture, import and sales of mercury containing products which will result in the reduction of releases of mercury to the environment from consumer products such as switches, thermometers and lamps. The proposed regulations are a key part of the overall Risk Management Strategy on mercury and would address the 2006 Senate Standing Committee on Energy, the Environment and Natural Resources’ recommendation to develop regulations for mercury in products. EC is targeting publication of the proposed regulations in Canada Gazette Part I in 2011. Consistent with Treasury Board Guide to the Federal Regulatory Process, a 75 day pre-publication period is required in order for Canada to fulfill its obligation of notification under various trade agreements. Comments will be carefully considered in developing the regulations which will subsequently be published in Canada Gazette Part II. Committee Recommendation 5: The Committee recommends that EC and HC Canada set interim targets and report progress in their performance reports for the 4,300 risk assessments and risk management strategies for toxic substances that are to be completed by 2020. Government Response A key feature of the CMP is its transparency in setting priorities and targets and reporting progress on the assessment and management of these substances. The CMP establishes a process to assess and manage the risks associated with substances that are used in many industrial and consumer products. Information on risk assessment and risk management activities, including timelines and targets as well as progress is available in the CEPA 1999 Annual Report, DPR and posted on the Chemical Substances website at: www.chemicalsubstanceschimiques.gc.ca The CMP was launched in 2006 to bring all existing federal programs together into a single strategy. The CMP is a science-based approach which aims to protect human health and the environment through:
The Domestic Substance List (DSL) forms the basis for distinguishing new substances from the inventory of ‘existing substances’ that were manufactured, imported or used in Canada on a commercial scale in the mid-1980s. As a first step in scientifically assessing all existing chemical substances known to be in commerce in Canada, CEPA 1999 required that the approximately 23,000 existing substances on the DSL be examined to determine if they were potentially harmful to human health or the environment, and to identify which ones warranted further attention. This resulted in a large-scale priority-setting exercise called “Categorization” wherein Government of Canada scientists worked with their partners to identify substances that were:
The CMP accelerated timelines for action on chemical substances, setting ambitious objectives to assess and where required, develop risk management strategies for all categorized existing substances in Canada by 2020. This will be accomplished by accelerating activities, reinvesting in science, and developing new and innovative partnerships with industry and with other countries to work collectively towards common goals. With the completion of Categorization in 2006, Canada became the first country to have systematically examined all substances known to be in commerce domestically. This process identified approximately 4,300 substances as priority for action. EC and HC are using a Rapid Screening approach to assess approximately 1,100 substances considered to be of low concern. Draft assessments were published in 2007 and final assessments will be published in early 2011. As substances can have different effects on human health and the environment, both EC and HC assess all substances which were identified as priorities for action. The Challenge to industry and other stakeholders was developed to address the approximately 200 chemical substances identified through categorization as representing the highest priorities for action, based on their total use in Canada and potential to cause harm to human health and/or the environment. The term Challenge was chosen because the Government of Canada uses mandatory information gathering instruments under CEPA 1999 to require new information from stakeholders about the use and management of these substances. Industry is required to complete and submit a survey, and interested stakeholders may also submit voluntary questionnaires or additional information that may be used to inform risk assessment and to develop and benchmark best practices for risk management and product stewardship. Starting in 2007, the Challenge process began launching a new ‘batch’ or group of substances every three months, signaling a six month period for industry and stakeholder groups to provide information. Screening Assessments are prepared by EC and HC scientists, based on available information, to make a determination as to whether the substance may be harmful to human health and/or the environment and therefore requires additional risk management actions. An external advisory body comprised of independent experts known as the Challenge Advisory Panel was formed to provide advice to the Government of Canada on the application of precaution and weight of evidence in screening assessment under the Challenge. The Challenge is on schedule to complete screening assessments for this group of approximately 200 chemicals by July 2011. As the Challenge process winds down, the Government will continue to assess the approximately 3,000 remaining substances identified through Categorization. In 2010, new information was collected on 550 substances as part of a broader effort to update the DSL, and to help inform appropriate activities on the next group of substances. The next round of assessment activity is currently being developed in consultation with stakeholders in order to efficiently address the remaining chemicals, taking into account a number of selection considerations, including health and environmental concerns and program efficiencies. Progress on the implementation of the CMP activities to address these chemicals is reported in the CEPA 1999 Annual Report, EC’s and HC’s DPR and on the Chemical Substances website at www.chemicalsubstanceschimiques.gc.ca |