5-Arseneau-1 - Chemicals Policy & Science Initiative

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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
Products
Land Use & Natural
Resource Mgt.
Canadian Environmental
Protection Act 1999
(WAPPRIITA)
Pest Control Products Act
Migratory Birds Act
Food and Drugs Act
SARA
Fisheries Act s.36
Feeds Act/Seeds Act
Canada Shipping Act
Fertilizer Act
Health of Animals Act
Transportation of Dangerous
Goods Act
Hazardous Products Act
Agriculture and Rural
Development Act
International River
Improvements Act
International Boundary Waters
Treaty Act
Canadian Environmental
Assessment Act
Indian and Northern Affairs
Act
PROVINCIAL GOVERNMENTS
Permitting through Ministries of Environment & Natural
Resources
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The Canadian Environmental Protection Act,
1999 enshrines key principles…
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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
Canada’s environment and health protection
framework
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CEPA provides mechanisms allowing the recognition
of equivalent sector-specific law and the avoidance
of duplication
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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 ongoing relevance to environmental issues
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So how do we deliver on these objectives?
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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
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Categorization: an initial priority-setting step
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a systematic review of our existing inventory of unassessed
substances
Domestic Substances List ~ 23,000 Substances
Persistent
Bioaccumulative?
Greatest Potential
For Human Exposure?
Inherently Toxic?
Screening Level Risk Assessment
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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
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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…
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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
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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
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CEPA 1999 Instruments
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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
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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
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The Qualitative Screening of Management Tool (QSMT) helps
risk managers:
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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:
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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…
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Environmental effectiveness
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Economic efficiency
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Would this tool result in inequitable distribution of costs and
benefits between sectors and regions?
Trade and investment obligations
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In achieving its projected level of effectiveness, is the tool likely
to result in benefits outweighing costs?)
Distributional impacts
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To what degree does the tool meet the Risk Management
Objective?
Does the tool respect Canada’s trade responsibilities/obligations?
Public and political acceptability and jurisdictional
compatibility
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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
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Virtual Elimination is a mandatory risk
management response
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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
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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
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Canadian tradition of Ministerial accountability
allows most decisions to be taken by responsible
Ministers or the federal Cabinet
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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.
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For legacy substances that have not undergone a
risk assessment of any kind,
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For the new substances framework,
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Outcomes from the categorization process will make
effective priority setting extremely important
Risk managers will be faced with increasing workloads
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
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Documents on CEPA, 1999 and the upcoming
review can be found at the CEPA Registry Website
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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
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www.ec.gc.ca/CEPARegistry/review/default.cfm
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