Substance Management

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Substance Management

• Current Canadian Approaches

John Arseneau Director General Risk Assessment
Directorate Environment Canada
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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
Fisheries Act s.36
Food and Drugs Act
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
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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

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and sound public policy approaches into
Canadas 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 CEPAs
  on-going relevance to environmental issues

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So how do we deliver on these objectives?

• A program to systematically review and assess the
  legacy of substances on Canadas 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

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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

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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.

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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

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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

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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

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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

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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 Canadas 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?)

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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

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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.

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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

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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