Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks - August 1, 2000

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2.3 Identify and Analyze Options

Consider a range of risk management options whenever possible. Take into account a variety of considerations when analyzing options, including the perspectives of interested and affected parties.

This step involves identifying and analysing potential options to prevent or reduce the risk of concern, and making recommendations regarding the preferred option(s).

Identify and Analyze Options - General Tasks

• Identify Potential Risk Management Options.
  
  
• Analyze Potential Risk Management Options.

Identify Potential Risk Management Options

A variety of options are available for risk management. Regulatory options generally rely on the government's authority to enforce compliance with legislation, and may include direct regulation, selfregulation and the issuing of permits or approvals. Non-regulatory options include the use of advisory, economic, and technological measures, and can include taking no action when none is required to maintain the current level of health protection. For further information, see the table that follows.

Options for Risk Management

Regulation

• Direct regulation involves the enforcement of requirements stated in legislation. Self-regulation involves allowing parties that produce the risk (risk producers) to create mechanisms to ensure that regulated processes or products conform to legislated requirements. The use of permits and approvals require risk producers to obtain written permission from government before undertaking a specific risk-producing activity.

National Guidelines

• National guidelines include voluntary standards and codes of practice that provide approaches for dealing with specific risk-related issues or undertaking specific risk-related activities.

Education/Advice

• Education/advice includes the provision of information that helps risk producers reduce risk, or that help interested or affected parties make more informed decisions.

Voluntary Compliance

• Voluntary compliance involves encouraging risk producers to take action that reduces risk. This is a good example of risk management through collaboration.

Economic

• Economic approaches are typically directed at risk producers, and use financial incentives or disincentives to limit risk; examples include providing financial assistance to developers of risk-reducing technologies and imposing penalties on polluters.

Technological

• Technological approaches involve the development of new risk-reducing methods or the application of existing methods by risk producers.

Taking No Action When None is Required

• This option involves maintaining the current level of health protection. It may be used for example, when the current level of risk is nsidered to be negligible, when the risk management strategy that is already in place is considered sufficient, or when there are no feasible, effective risk management options to implement.

A number of factors may be considered when identifying potential risk management options, including legislative authority, policies, and commitments, and how quickly the risk must be addressed. A wide range of potential options should be identified unless the nature of the risk issue or situation makes it unwise, unnecessary, or impossible to do so (e.g. there is a crisis situation which requires a quick response; the only option based on legislative requirements is direct regulation).

To the extent possible and appropriate for the given situation, options should be identified in consultation with a range of interested and affected parties. This is especially important in cases of where the responsibility for managing the risk is shared, or where various parties may participate in implementation of the selected strategy. The breadth and depth of consultation should reflect factors such the nature of the issue, who the issue affects, the urgency required to resolve the issue, and the resources available.

Options Used by Health Canada: Some Examples

Health Canada uses a combination of regulatory and non-regulatory approaches for risk management. Regulatory options are most frequently used, with the most common being direct regulation. The most commonly used non-regulatory options are national guidelines, advice/education, and voluntary compliance (an example of the latter is the 1996 removal of lead-containing miniblinds from Canadian stores, in response to a health advisory issued in the United States). Technological approaches are also sometimes used, in conjunction with legislation (e.g. the development of childproof cigarette lighters, which fall under the Hazardous Products Act).

Analyze Potential Risk Management Options

A number of factors may be considered when analysing potential risk management options. The expected effectiveness of potential options (especially for different populations), and legislative, international trade, or other requirements, obligations, and limitations are key considerations, as is the feasibility of the option (in terms of technological, legal, economic, and other factors). Other considerations may include:

• how quickly the risk must be addressed;
  
  
• risks vs. benefits;
  
  
• expected costs (of implementing the option);
  
  
• risk, cost, and benefit ratios (efficiency);
  
  
• distribution of risks, costs, and benefits (fairness);
  
  
• available resources;
  
  
• unintended consequences (e.g. creation of a new risk, or unwanted social, cultural, ethical, environmental and other indirect health impacts);
  
  
• residual risk (level of risk that remains after the option is implemented);
  
  
• the perceptions, concerns, and values of interested and affected parties;
  
  
• acceptability of the risk, the option, and the residual risk to interested and affected parties; and
  
  
• other criteria used for option analysis in similar situations.

The nature and relative importance of the criteria used for option analysis will vary depending on the situation being addressed, and may be influenced by existing legislation. Some options may be eliminated quickly for various reasons. A shorter list of potential options can then be produced, and a more detailed analysis performed on this list. In general, preferred risk management options are those that provide an "acceptable" level of health protection, are most effective in reducing or preventing the risk, cost the least, create the fewest adverse unintended consequences, and are acceptable to a wide range of interested and affected parties.

In some cases, options analysis can serve to refine the goal of the risk management process. This may occur once risk managers and other interested and affected parties gain some appreciation for what is feasible, what the costs and benefits are, and what contribution reducing exposures and risks can make toward improving human health.

Involving Interested and Affected Parties
Interested and affected parties can play an important role in option analysis by helping to identify criteria to be used for analysis, collecting or providing required information, participating in analyses, providing a range of perspectives on the acceptability of the criteria and the results of the analysis, and helping to redefine risk management goals as required.

Some Key Considerations
One key consideration when analysing options is that the same measures can affect different populations in different ways depending on a range of risk factors such as gender, age, ethnic origin, social situation, economic conditions, education, culture or personal convictions. It may be necessary to tailor options to meet the needs of specific groups or to use different options for different groups. For example: advisory information could be provided at different reading levels, through different types of news media, and in different languages; recommended daily intakes of specific chemical contaminants in food could be different for general and sensitive populations.

A second consideration is Health Canada's difficult but necessary responsibility to balance the rights of individuals and groups with the needs and interests of society. Related to this is the importance of ensuring that societal and group rights do not unnecessarily override the rights of the individual. In principle, when the rights of an individual and society are in conflict, precedence should be given to the latter; in practice this may be a challenge to achieve.

A third consideration is the difficulty in determining what constitutes an "acceptable" level of risk. An acceptable risk is one that is so small, whose consequences are so slight or whose associated benefits (perceived or real) are so great, that persons or groups in society are willing to take or be subjected to that risk. The acceptability of risk, from both an individual and social perspective, is influenced by risk perception, values, judgments and other factors, such as the trade-offs people make between potential risks and benefits. The level of trust in the person or agency responsible for managing the risk is also a factor.

Although individuals may hold opinions about what is acceptable, there are often no objective measures for determining acceptability. What is acceptable to one group or individual may be unacceptable to another. Given this, attempts need to be made to determine acceptability from the perspectives of a range of interested and affected parties (e.g. women, cultural minorities, seniors, children and other groups).