Substance Management

Substance Management Current Canadian Approaches John Arseneau Director General Risk Assessment Directorate Environment Canada

In Canada, authorities for environmental management are shared Protection from Pollution Land Use & Natural Resource Mgt. Products Canadian Environmental Protection Act 1999 (WAPPRIITA) SARA Migratory Birds Act Pest Control Products Act Agriculture and Rural Development Act Food and Drugs Act Fisheries Act s.36 International River Improvements Act Feeds Act/Seeds Act Canada Shipping Act International Boundary Waters Treaty Act Fertilizer Act Canadian Environmental Assessment Act Health of Animals Act Indian and Northern Affairs Act Transportation of Dangerous Goods Act PROVINCIAL GOVERNMENTS Hazardous Products Act Permitting through Ministries of Environment & Natural Resources

The Canadian Environmental Protection Act, 1999 enshrines key principles… • Pollution Prevention – avoid, not manage, pollution • Virtual Elimination – releases of substances that are persistent, bioaccumulative, CEPA-toxic, and anthropogenic should be reduced to point that the releases can no longer be measured • Ecosystem Approach – natural geographic units, not political boundaries (e.g., Great Lakes) • Precautionary Principle – in cases of severe or irreversible harm, lack of certainty will not prevent action • Intergovernmental Cooperation – directs inter-jurisdictional cooperation • Science-based Decision-Making – science is fundamental to risk assessment while social and economic considerations are brought to bear during risk management • Research & Monitoring – Compels and empowers government gather information on pollution, industrial activity, and monitor environmental effects

… and sound public policy approaches into Canada’s environment and health protection framework • CEPA provides mechanisms allowing the recognition of equivalent sector-specific law and the avoidance of duplication • Pest Products Control Act – Pest Management Regulatory Agency • Hazardous Products Act – Health Canada • Transparency requirements are specific and numerous to ensure predictable and transparent processes for all stakeholders • Periodic review (every 5 years) ensures CEPA’s on-going relevance to environmental issues

So how do we deliver on these objectives? • A program to systematically review and assess the legacy of substances on Canada’s domestic inventory • A new substances notification program that must operate within strict legislated time-frames while bearing responsibility for all areas not regulated under other legislation, including biotechnology • Use of a broad range of risk management instruments to respond to identified risks within prescribed time-frames • Monitoring networks for air and water • A legislated National Pollutant Release Inventory to provide public with information on pollution sources and releases in their region and to complete the assess, manage, monitor, report circle

Domestic Substances List ~ 23,000 Substances Persistent Bioaccumulative? Greatest Potential For Human Exposure? Inherently Toxic? Screening Level Risk Assessment Categorization: an initial priority-setting step • a systematic review of our existing inventory of unassessed substances • assessment priorities also come from industry information, emerging science, international assessments, and decisions, new substances notifications, and public nominations

Substances “categorized in” must be assessed & appropriately managed • Categorization faces a September 2006 dead-line for conclusion • Subsequently, we are mandated to conduct risk assessments on all substances that met the categorization criteria • Where management is chosen, proposed instruments must be developed within 24 months and put in place in a further 18 months.

The authority to require information helps us to meet our assessment obligations… • CEPA compels users of substances to provide any information that could support a finding that a substance requires management • The Minister can compel users to provide information on specific substances in support of risk assessment/management activities • Notifiers of new substances are required to provide the information necessary to enable the assessment of risks posed by substance for the planned use • Tiered information requirements • Flexibility to require more data, either experimental or modelled, based on findings

… and wide array of instruments, often used in combination, allows for efficient risk management • CEPA 1999 Instruments • Pollution Prevention Plans • Guidelines • Environmental Performance Agreements • Economic instruments • Traditional Regulation • Administrative agreements • Interim Orders • Other Federal Acts, including economic measures • Federal-Provincial initiatives • Voluntary Approaches

Several considerations are taken into account when selecting risk management tools • technical and socio-economic aspects of the substance; • profile of sector(s) involved; • speed and impact of the risk management tool; • compatibility of the tool with existing environmental controls and jurisdictional responsibilities; • the flexibility the tool allows in achieving its objective; • the impact of the tool on trade; and • the effect and cost of the management tool on the private sector, government and the general public;

… all through a systematic approach recognized as model for other federal government departments • The Qualitative Screening of Management Tool (QSMT) helps risk managers: • evaluate a range of management tools against a set of criteria to identify the most promising two or three options, and • keep track of assumptions for review and reference in future phases of tool selection, such as quantitative assessment. • Inputs to the QSMT include: • Results of the Environmental and Health Risk Assessment for the substance(s), • An environmental objective and a risk management objective, • Technical and socio-economic background and necessary data related to the substance(s), and • A list of the viable risk management tools

Each potential risk management tool is assessed against the same criteria… • Environmental effectiveness • To what degree does the tool meet the Risk Management Objective? • Economic efficiency • In achieving its projected level of effectiveness, is the tool likely to result in benefits outweighing costs?) • Distributional impacts • Would this tool result in inequitable distribution of costs and benefits between sectors and regions? • Trade and investment obligations • Does the tool respect Canada’s trade responsibilities/obligations? • Public and political acceptability and jurisdictional compatibility • Would this tool receive political and public support and be compatible with existing or proposed control measures in other jurisdictions?)

… but for high hazard, persistent, bioaccumlative & anthropogenic substances • Virtual Elimination is a mandatory risk management response • Defined as reducing releases to the environment to a level below that which can be measured using sensitive, but routine testing methods • Definitions for persistence and biaccumulative are prescribed in regulation • Whenever an assessment finds that these criteria are met, the Government is compelled implement virtual elimination

CEPA, within the Canadian system of government, provides a great degree of flexibility • Canadian tradition of Ministerial accountability allows most decisions to be taken by responsible Ministers or the federal Cabinet • Through CEPA, Parliament delegates regulation-making power to the Executive • While the Minister of the Environment takes leadership in the administration of the Act, responsibilities are shared equally with the Minister of Health • However, periodic reviews of the Act are done by Parliament, which ultimately determines the form of each new iteration of the statute.

Nevertheless, there are areas where more is needed. • For legacy substances that have not undergone a risk assessment of any kind, • Outcomes from the categorization process will make effective priority setting extremely important • Risk managers will be faced with increasing workloads • For the new substances framework, • Governance of biotech regulation remains unclear, but work is underway • Emerging issues such as nanotechnology has revealed weaknesses in the framework • Risk managers, for new and existing substances, will increasingly face challenges in dealing with substances found in finished products and other manufactured goods

Further Reading • Documents on CEPA, 1999 and the upcoming review can be found at the CEPA Registry Website • www.ec.gc.ca/ceparegistry • In particular, A Guide to Understanding the Canadian Environmental Protection Act, 1999 will serve as a comprehensive backgrounder on the Act • www.ec.gc.ca/CEPARegistry/review/default.cfm

Substance Management