Overview of the Existing Substances Program
2. CEPA 1999 Guiding Principles and other policies
The Government of Canada's environmental protection strategy is driven by a vision of sustainable development. Inherent in the strategy is the key outcome of pollution prevention. This vision depends on a clean, healthy environment, and a strong economy. Controlling substances that can cause harm to human health or the environment is a key component of this vision, ensuring any risks from substances are prevented or reduced. Controlling substances is a single process that occurs in two phases: risk assessment and risk management. The first, risk assessment, is a science-based evaluation which allows weight-of-evidence based decision making on whether a substance poses a risk. The second phase, risk management, represents the Government's response to the risk identified, which takes into consideration socio-economic factors and identifies the most suitable control measures. Assessment and the supporting science provide the necessary information for risk management activities. Acceptability of the risk assessment outcome and the risk management approach are largely dependent on good risk communication, which involves the public and stakeholder engagement at key steps of the process.
2.1 The Canadian Environmental Protection Act, 1999
The Canadian Environmental Protection Act, 1999 (CEPA 1999) is the principal federal legislative tool for preventing pollution and recognizes that the protection of the environment is essential to the well-being of Canadians.
In implementing their programs, Health Canada and Environment Canada, as administrators of CEPA 1999, are responsible to ensure that:
- there is public participation, openness and transparency in decision making and that there are mechanisms available for supporting these goals;
- there is commitment to promotion of human health and implementation of pollution prevention, as national goals;
- the Government of Canada is able to fulfill its international obligations with respect to the environment;
- the precautionary principle is implemented;
- the polluter pays principle is implemented;
- the importance of an ecosystem approach is recognized;
- the risk of toxic substances is recognized as a matter of national concern that transcends geographic boundaries;
- a consistent process for collaboration with other jurisdictions results in effective and integrated approaches, policies and programs to manage the risks to human health and the environment posed by the threats of toxic substances; and
- action is taken to apply all aspects of the program in a fair, predictable, transparent and consistent manner.
Parts 4 and 5 of CEPA 1999 provide the legislative framework for the assessment and management of substances that can enter into the Canadian environment. The framework ensures the protection of the environment and of the health of Canadians from harmful substances and other pollutants.
Program activities are also guided by a variety of Government guidelines and policies, especially those outlined in:
- "Toxic Substances Management Policy" (Government of Canada, 1995);
- "Science Advice for Government Effectiveness (SAGE)" (CSTA, 1999); and
- "Framework for the Application of Precaution in Science-based Decision Making about Risk" (PCO, 2003).
2.2 Toxic Substances Management Policy
The federal Toxic Substances Management Policy, introduced in 1995, takes a preventive and precautionary approach to dealing with substances that enter the environment and that could harm the environment or human health. It provides decision makers with direction and sets out a science-based management framework to ensure that federal programs are consistent with the objectives of the policy. Some elements of the policy have been integrated into law through CEPA 1999.
The key management objectives of the policy are:
- the virtual elimination from the environment of toxic substances that result predominantly from human activity and that are persistent and bioaccumulative (referred to as Track 1 substances); and
- management of other toxic substances and substances of concern throughout their entire life cycles, to prevent or minimize their release into the environment (referred to as Track 2 substances).
Consistent with this policy, risk managers at Health Canada and Environment Canada use the information provided by risk assessments to develop appropriate approaches to manage the risks posed by toxic substances. Through its risk assessment activities, the Existing Substances Program provides a key mechanism for identifying candidate substances for risk management, and is an important contributor to decision making by risk managers.
A toxic substance is defined under section 64 of CEPA 1999 as being a substance that:
"... is entering or may enter the environment in a quantity or concentration or under conditions that
- have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- constitute or may constitute a danger to the environment on which life depends; or
- constitute or may constitute a danger in Canada to human life or health."
Toxic substances that are both persistent and bioaccumulative have been recognized as requiring special attention, as reflected in both domestic and international regulatory and policy frameworks. Once in the environment, it may be difficult or impossible to manage these substances or remediate past contamination. In addition, remote and cold regions, such as the Canadian Arctic, can act as global sinks for some of these compounds, making it important for Canada to act both domestically and internationally. Although it may not be possible to accurately predict all of the effects of these substances on the environment, the potential exists for these substances to cause long-term impacts. The use of a preventive approach in assessment of these substances is particularly important to ensure that harm to the environment and its biological diversity does not occur.
Substances that meet the criteria set out under section 64 of CEPA 1999 are considered for risk management measures such as regulations, guidelines or codes of practice, to control any aspect of their life cycle, from the research and development stage through manufacture, use, storage, transport and ultimate disposal.
Furthermore, when a substance meets the criteria set out under section 64 and is persistent, bioaccumulative and results primarily from human activity, it is proposed for virtual elimination under CEPA 1999.
More information on Risk Management can be found on the Management of Toxic Substances web section.
2.3 Role of science in decision making
Science Advice for Government Effectiveness (SAGE) was developed by the Council of Science and Technology Advisors, an external advisory committee, in May 1999 in response to the request by the Cabinet Committee on Economic Union to examine how the government could improve its use of science advice in reaching decisions and its explanations about how those decisions are reached. The SAGE report identified six key principles:
- Early Issue Identification
- Sound Science and Science Advice
- Uncertainty and Risk
- Transparency and Openness
The SAGE report provided the basis for the development of a government-wide set of principles and guidelines for the effective use of science in making policy and regulatory decisions, which is captured in the Government of Canada paper entitled "A Framework for Science and Technology Advice: Principles and Guidelines for the Effective Use of Science and Technology Advice in Government Decision Making" (Government of Canada, 2000). The principles and guidelines in the report address how science advice should be sought and applied to enhance the ability of government decision makers to make informed decisions. While some of these are suitably applied only at higher levels of the organization or at later stages of the toxics management process, many of them are directly applicable within the Existing Substances Program.
Environment Canada's "Science Advice for Government Effectiveness: Recommendations for Implementing the SAGE Principles" (ECSTAB, 1999) and Health Canada's "Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks" (Health Canada, 2000) demonstrate the Government of Canada's dedication to implementation of the SAGE principles as a whole and recognizes their importance to the values of a science-based department. These documents note that science assessment is a key discipline for delivering science to policy makers.
2.4 Precaution in science-based decision making
The Federal Government has developed a document entitled "A Framework for the Application of Precaution in Science-based Decision Making about Risk" [Privy Council Office (PCO), 2003]. This paper addresses the application of precaution in its various forms - "precaution", "the Precautionary Principle" or "the precautionary approach" - all of which have three basic components: the need for a decision; a risk of serious or irreversible harm; and a lack of full scientific certainty.
As stated in the document, the application of precaution primarily affects the development of options and the decision phases within science-based risk management, is clearly linked to scientific analysis, and cannot be applied without an appropriate assessment of scientific factors and consequent risks. A key role of developing ecological and human health risk assessments is to provide the necessary evaluation of science and potential risks to support the use of precaution in the ultimate decision making process, at which point factors such as social and ethical values and political and economic considerations will also be taken into account.
The "precautionary principle" is entrenched in CEPA 1999. In the preamble, CEPA 1999 recognizes that the "Government of Canada is committed to implementing the precautionary principle. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation." In addition, section 76.1 of CEPA 1999 specifically directs the Ministers to apply a weight-of-evidence approach and the precautionary principle when conducting and interpreting the results of assessments of existing substances.
As described in greater detail in PCO (2003), the general principles outlining the distinguishing features of precautionary decision making are that:
- The application of precaution is a legitimate and distinctive decision-making approach, notably within risk management.
- It is legitimate that decisions be guided by society's chosen level of protection against risk.
- In risk management, sound scientific information and its evaluation must be the basis for the decision to apply precaution and the measure selected in applying precaution; the scientific information base and responsibility for producing it may shift as knowledge evolves.
- Mechanisms should exist for re-evaluating the basis for decision and for providing a transparent process for further consideration, recognizing that in some cases re-evaluation may not be practical or productive.
- A high degree of transparency, clear accountability and meaningful public involvement are appropriate.
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