Risk Management Frameworks for Human Health and Environmental Risks

Abstract

A comprehensive analytical review of the risk assessment, risk management, and risk communication approaches currently being undertaken by key national, provincial/state, territorial, and international agencies was conducted. The information acquired for review was used to identify the differences, commonalities, strengths, and weaknesses among the various approaches, and to identify elements that should be included in an effective, current, and comprehensive approach applicable to environmental, human health and occupational health risks. More than 80 agencies, organizations, and advisory councils, encompassing more than 100 risk documents, were examined during the period from February 2000 until November 2002. An overview was made of the most important general frameworks for risk assessment, risk management, and risk communication for human health and ecological risk, and for occupational health risk. In addition, frameworks for specific applications were reviewed and summarized, including those for (1)contaminated sites; (2) northern contaminants; (3) priority substances; (4) standards development; (5) food safety; (6) medical devices; (7) prescription drug use; (8) emergency response; (9) transportation; (10) risk communication. Twelve frameworks were selected for more extensive review on the basis of representation of the areas of human health, ecological, and occupational health risk; relevance to Canadian risk management needs; representation of comprehensive and well-defined approaches; generalizability with their risk areas; representation of "state of the art" in Canada, the United States, and/or internationally; and extent of usage of potential usage within Canada. These 12 frameworks were: 1. Framework for Environmental Health Risk Management (US Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997). 2. Health Risk Determination: The Challenge of Health Protection (Health and Welfare Canada, 1990). 3. Health Canada Decision-Making Framework for Identifying, Assessing and Managing Health Risks (Health Canada, 2000). 4. Canadian Environmental Protection Act: Human Health Risk Assessment of Priority Substances(Health Canada, 1994). 5. CSA-Q8550 Risk Management: Guidelines for Decision-Makers (Canada Standards Association, 1997). 6. Risk Assessment in the Federal Government: Managing the Process (US National Research Council, 1983). 7. Understanding Risk: Informing Decisions in a Democratic Society (US National Research Council, 1996). 8. Environmental Health Risk Assessment (enHealth Council of Australia, 2002). 9. A Framework for Ecological Risk Assessment (CCME, 1996). 10. Ecological Risk Assessments of Priority Substances Under the Canadian Environmental Protection Act (Environment Canada, 1996).11. Guidelines for Ecological Risk Assessment (US EPA, 1998b). 12. Proposed Model for Occupational Health Risk Assessment and Management (Rampal & Sadhra, 1999). Based on the extensive review of these frameworks, seven key elements that should be included in a comprehensive framework for human health, ecological, and occupational risk assessment and management were identified: 1. Problem formulation stage. 2. Stakeholder involvement. 3. Communication. 4. Quantitative risk assessment components. 5. Iteration and evaluation. 6. Informed decision making. 7. Flexibility. On the basis of this overarching approach to risk management, the following "checklist" to ensure a good risk management decision is proposed: - Make sure you're solving the right problem. - Consider the problem and the risk within the full context of the situation, using a broad perspective. - Acknowledge, incorporate, and balance the multiple dimensions of risk. - Ensure the highest degree of reliability for all components of the risk management process. - Involve interested and effected parties from the outset of the process. - Commit to honest and open communication between all parties. - Employ continuous evaluation throughout the process (formative, process, and outcome evaluation), and be prepared to change the decision if new information becomes available. Comprehensive and sound principles are critical to providing structure and integrity to risk management frameworks. Guiding principles are intended to provide an ethical grounding for considering the many factors involved in risk management decision making. Ten principles are proposed to guide risk management decision making. The first four principles were adapted and modified from Hattis (1996) along with the addition of two more principles by Hrudey (2000). These have been supplemented by another four principles to make the 10 presented. The principles are based in fundamental ethical principles and values. These principles are intended to be aspirational rather than prescriptive--their application requires flexibility and practical judgement. Risk management is inherently a process in search of balance among competing interests and concerns. Each ri