Workshop on Guiding Public Health Policy
in Areas of Scientific Uncertainty
July 11-13, 2005.
McLaughlin Centre for Population Health Risk Assessment Institute of Population Health University of Ottawa
In partnership with the World Health Organization
WORKSHOP REPORT
Prepared by Lorraine Craig, M.H.Sc.
[email protected] TABLE OF CONTENTS
1.0 Workshop Overview ...... 1
2.0 Introduction to the Framework ...... 3
2.1 Overview of the Framework ...... 3
2.2 European Perspective on the Protection of Human Health...... 5
2.3 Discussion of Framework Elements ...... 7
2.3.1 Putting Health Issues into Context...... 7
2.3.2 Option Generation and Assessment...... 8
2.3.3 Integrating Public Perception in the Precautionary Principle...... 9
2.3.4 Scientific Risk Assessment and Uncertainty ...... 10
2.3.5 Action Implementation and Evaluation ...... 10
2.3.6 Legal Aspects of Using Precaution...... 11
2.3.7 Plenary Discussion of Framework...... 14
3.0 Case Studies to Test the Framework...... 15
4.0 Stakeholder Perspectives on Precaution ...... 23
5.0 Direction for Improvements to the Draft Framework Document ...... 42
Appendix A –List of Participants Appendix B –Meeting Agenda & Speaker Biographies Appendix C –June 2005 Draft WHO Document
2 Workshop on Guiding Public Health Policy in Areas of Scientific Uncertainty
1.0 Workshop Overview
More than 120 scientists, academics, regulators, and representatives of industry and non-governmental organizations from 17 countries worldwide convened at the University of Ottawa on July 11-13, 2005 to participate in a Workshop on Guiding Public Health Policy in Areas of Scientific Uncertainty (see Appendix A for List of Participants). The Workshop was spearheaded by the World Health Organization (WHO) and organized in collaboration with the McLaughlin Centre for Population Health Risk Assessment to seek stakeholder feedback on a draft WHO framework designed to assist member states in managing issues where scientific evidence of the risks is uncertain.
The lack of global scientific consensus on the long term health risks associated with electromagnetic radiation exposures from cellphones has resulted in inconsistent radiation exposure standards around the world. As a result, WHO initiated the development of the framework in parallel with their International EMF project to provide assistance to regulators in member states in formulating policies on the EMF issue and other emerging issues in which technological development has outpaced the scientific assessment of the risks.
The objectives of the workshop were to:
Discuss the use of precautionary measures in the development of public health policy Review and provide useful inputs on the draft Fretwork Discuss the implications of its implementation with stakeholders Challenge the Framework to a series of relevant case studies to ensure it is useful and practical Critique the Framework so it can withstand reasonable criticism and therefore serve as a “global” Framework
To achieve the above objectives, the workshop format was structured according to four main sessions: i) presentation of the framework and discussion of the key framework elements; ii) presentation and discussion of case studies to assess the framework and identify needs for the framework based on past experiences in environmental risk management; iii) presentation of stakeholder perspectives on the framework (presentations and panel discussion); and iv) a concluding plenary discussion of strengths and weaknesses in the draft framework and opportunities to further improve the Framework.
The workshop presenters included representatives from WHO, Public Health Agency of Canada, University of Ottawa, University of Toronto, University of Montreal, Pollution Probe, PAHO, National Gird Transco/UK, Decisionalysis Risk Consultants Inc., City of Ottawa Department of Public Health, American Chemistry Council, Shell Canada, Elanco/U.S. office and GSM Association/Ireland (see Appendix B for Meeting Agenda and Speaker Biographies).
Jeannette Ward, Director of the Institute for Population Health, provided welcoming remarks, noting the timeliness and importance of WHO's work in developing a robust framework for health professionals and decision-makers at the global level and the McLaughlin Center’s world recognized work in health risk assessment and recent designation as a WHO Collaborating Centre.
David Butler-Jones, Chief Public Health Officer of the Public Health Agency of Canada provided an opening address. He commented on the complexity of today’s public health issues and the interconnectedness between social determinants, genetic and environmental influences on population
1 health. He discussed the importance of balancing tradeoffs in decision-making and the need to intervene to accomplish the most with the fewest side effects. He noted the difficulty for the public and the media to understand the complexity of emerging public health issues. The importance of debate and the involvement of a range of disciplines and communities in discussions on questions such as what is the risk, what does it mean and what are the tradeoffs were identified as a key elements in public health decision-making process.
Michael Repacholi of World Health Organization set the context for the workshop by presenting an overview of WHO’s activities on the issue of precautionary principle leading to the development of the draft WHO Framework on Guiding Public Health Policy Options in Areas of Scientific Uncertainty. These activities have included participation in various international workshops, conferences and symposia on the precautionary principle (Rome, 2001; Vancouver, 2002; Bologna, 2002) preparation of a WHO/EURO briefing paper on Children’s Environmental Health (June 2004) and activities focused on application of precaution to EMF. He described the International EMF Project, established in 1996 to assess the health and environmental effects of exposure to EMF and WHO's activities related to assessing scientific evidence, policy development and communication.
WHO has traditionally provided advice to national authorities to set policy on public health issues for which the scientific knowledge is well established. The growing movement, particularly in Europe and increasingly around the world, to adopt precautionary approaches to decision-making on health risks where there is science is unclear resulted in the need for WHO to look at precaution. The draft WHO Framework was developed in response to the regulatory confusion and public concern resulting from inconsistencies in EMF standards around the world, particularly the adoption of standards considerably more stringent than international standards in some locations as a precautionary response to scientific uncertainty on the potential public health impacts. Dr. Repacholi described the framework as a bottom up approach within WHO to address precaution in EMF policy. Is it envisioned that the WHO framework will be developed first for the EMF issue and then adapted for broader application to other public health issues within WHO.
This workshop summary report is one of several products of the workshop. The intent of the report is to provide a record of the workshop presentations and discussion so that the comments and suggestions can be further considered by WHO in their revisions to finalize the Framework document. A summary of the suggestions provided by delegates for improvement to the next version of the Framework is provided in Section 5.0. The June 2005 draft Framework document discussed at the workshop is provided in Appendix C. Readers may also wish to refer to the WHO Workshop website http://www.who.int/peh- emf/meetings/ottawa_june05/en/index1.html for additional information.
2 2.0 Introduction to the Framework
A number of issues were raised in plenary discussion following Dr. Repacholi’s introductory presentation. One delegate pointed out the importance of clearly defining three terms: uncertainty, precaution and precautionary principle as these terms are applied differently in North America and Europe and mean different things to different people. Dr. Daniel Krewski, Professor and Director of the R. Samuel McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa referred to a review of risk management frameworks for human health and environmental risks that was undertaken by the Network for Environmental Risk Assessment and Management (www.irr-neram.ca) for the Federal/Provincial/Territorial Committee on Environmental and Occupational Health1. Based on the review, ten guiding principles for risk management decision-making were established. He indicated that the principles are relevant to issues that will be discussed in the workshop.
On the EMF issue, one delegate noted that public concern is related to uncertain health effects rather than the lower standards. Another delegate commented that there is a gradual scale between certainty and uncertainty and raised the question when animal studies show DNA breakage and increased risk of abnormal brain tumors at what stage can we say that this is legitimate science and move policy to reduce exposures at a large scale. Dr. Repacholi indicated that precautionary decision-making is not something new at WHO. Precaution is an overarching approach in risk management and the intent of the Framework is to document what has always been done in a way that is useful and, practical for member states. Dr. Repacholi noted the importance of a rigorous assessment of studies and the use of a weight of evidence approach. The Framework provides guidance on reducing exposures in a cost-effective way. If there is a reasonable probability of major health effects, precautionary measures should be more severe. If the health effects are less severe, a more cost-effective approach is warranted. Science should be the main driver for precautionary actions.
2.1 Overview of the Framework
Dr. Emilie van Deventer of World Health Organization provided an overview of the June 2005 WHO Draft Framework on Guiding Public Health Policy in Areas of Scientific Uncertainty (see Appendix C). Dr. van Deventer noted that when an agent is ubiquitous or the potential for harm is great, it is reasonable to apply precaution and act with foresight before concentration exposure relationships can be established and quantified. However, indiscriminate use of precaution can lead to large disparities between national policies and can foster confusion for regulators and policymakers and increase public concern and anxiety.
The Framework is designed for policymakers and regulators of WHO member states for two primary purposes: i) to provide guidance on setting public health policies in areas of scientific uncertainty and ii) to reduce the likelihood of long-term public health risks from exposure to any agent using science and cost-effective measures. Dr. van Deventer noted that the precautionary principle as a concept lacks a clear and universally accepted definition. The European Environment Agency (2004) defined the main ingredients of precautionary principle:
“a framework, procedures and policy tools for public policy actions in situations of scientific complexity, uncertainty and ignorance where there may be some need to act before there is strong proof of harm to avoid, or reduce, potentially serious or irreversible threats to health or the environment
1 Jardine, C.G., Hrudey, S.E., Shortreed, J., Craig, L., Krewski, D., Furgal, C., and McColl, S. 2003. Risk Management Frameworks for Human Health and Environmental Risks. Journal of Toxicology and Environmental Health. Part B, 6: 569-641.
3 using an appropriate level of scientific evidence, and taking into account the likely pros and cons of action and inaction”
Dr. van Deventer indicated that there are differences in the ways that precaution is being adopted in the European Community, Canada, and Switzerland. For example, in Switzerland the precautionary principle is enshrined in primary legislation. New Zealand and various countries in Europe are currently discussing the use of precaution particularly for protection of environmental impacts.
The WHO Framework is based on the paradigm of the 1997 U.S. Presidential Congressional Commission on Risk Assessment and Risk Management (http://www.riskworld.com). The Framework is illustrated as a series of six iterative stages with stakeholder engagement and consultation as an essential aspect of the entire process (see Figure 1).
Health issue in Context
Action Risks Evaluation Evaluation
Stakeholder Participation Action Option Implementation Generation Risk profile Option Risk assessment Assessment and Selection Risk management
Figure 1. Iterative process for the Framework
Dr. van Deventer identified the following four guiding principles that underlie the framework:
1. Precaution is seen as an overarching approach rather than being triggered when a certain level of evidence is exceeded. 2. Science is key to the process. Precaution complements rather than replaces science based risk management. For any risk, scientific evaluation will identify established effects and gaps in knowledge. There are many different types of uncertainties ranging in a continuum from ignorance to gaps in knowledge to established knowledge. 3. Public concern may be a trigger to consider precautionary measures but should not be used to set precautionary policies. 4. Communication and consultation with stakeholders should occur at all appropriate stages.
Dr. van Deventer identified a series of key questions to consider before using the Framework. For example, is there a legislative framework that provides for the process to commence? Is there a mandate and an approval process for an agency to lead the process? Are there appropriate scientific experts and government representatives to form a committee to manage the process? Is there funding to complete the process?
In assessing the health issue in context, Dr. van Deventer emphasized the importance of considering the characteristics of the hazard that influence risk perception (immediate or delayed, reversible or irreversible, voluntary vs. involuntary exposure, severity of consequences, affected sub-groups etc.) as well as the social, political and health context. In assessing the risks it is important to use a weight of evidence approach and clearly identify the uncertainties and assumptions. Options range from do nothing,
4 ban, to individual choice, behavior modification and voluntary measures. Dr. van Deventer indicated that it is important to consider precautionary measures prior to introduction of a new product or technology on the market. For option assessment and selection, cost-effectiveness analysis is preferred to cost benefit analysis since benefits are difficult to quantify for precautionary measures. At the selection level, political, environmental and social realities need to be made explicit. Cost is only one criterion for the selection of measures. Dr. van Deventer identified five selection criteria proposed by the European Commission (2000): i) proportional to the chosen level of risk; ii) non-discriminatory in their application; iii) consistent with similar measure already taken; iv) based on an examination of the potential benefits and costs of action or lack of action; and v) subject to review, in light of new scientific data. Action implementation is usually in response to the requirement of regulatory agencies, however voluntary measures may also require additional resources for communication strategy development etc. Action evaluation for precautionary measures may include monitoring of exposure and public concern, public health surveillance, and review of actions in light of new scientific information.
Dr. van Deventer concluded that the Framework provides for the development of reasonable and realistic options. It includes consideration of tradeoffs and encourages scientific research and iterative evaluation of policies. She noted that feedback on the draft Framework has been received from 47 stakeholders in 18 countries, representing a range of stakeholders including industry, law, associations, scientists, general public, risk specialists and government agencies. This feedback has indicated that case studies are useful. Stakeholders identified the need for more concrete guidance and further discussion on criteria to weigh qualitative and quantitative data, the role of public concern, and methods for valuation of benefits of precautionary measures.
Plenary Comments
How will precautionary approaches to EMF differ from what has already been done for example incorporating safety margins in setting international exposure limits and occupational exposure limits? Other types of precautionary measures may include increasing right of way around high voltage power lines, the option of using handsets for mobile phones, there are many measures that are distinct from exposure limits. One of the progressions that have been made since the Red Book in 1980 is the growing recognition of the importance of stakeholder involvement. In the WHO Framework it is the central circle. How do you plan to integrate stakeholders in deliberative processes to frame the issues and engage in discussions on judgments used in risk assessment? How will this be addressed in the framework to suit the needs of different countries and societies? This is a good point and obviously it is something we have to address in a generic framework and leave to countries to decide how best to implement it. It is very much a cultural issue and some countries don’t include the public in all stages and may not need to include at all stages. The European Commission 2000 paper also states that the absence of scientific proof of cause- effect relationships and evaluation of probability of adverse effect should not be used to justify inaction. It seems important to consider this in the case of EMF.
2.2 European Perspective on the Protection of Human Health
Dr. Marco Martuzzi, of the World Health Organization, European Regional Office provided a European perspective on the protection of human health. Dr. Martuzzi reviewed key declarations in Europe arising from Ministerial Conferences on Environment and Health where Ministers of health and environment of
5 all member states of the Regional Office of Europe of WHO meet every five years to agree on principles, priorities and a common agenda. The latest conference “The Future of our Children” held in Budapest in 2004 focused on children’s health, future generations health and sustainable development. The main outcomes of the conference were a Ministerial Declaration and the Children Environment and Health Action Plan for Europe (CEHAPE). The Plan is largely based on evidence of health implication of environmental exposures in a European context. Dr. Martuzzi noted that Precautionary principle is addressed in art 174 of EC Treaty: “Community policy on the environment (…) shall be based on the precautionary principle (…) that preventive action should be taken…”.The London Declaration on Action in Partnership adopted at the Third Ministerial Conference on Environment and Health (June 1999) further states “We will develop initiatives in our countries to give greater emphasis in all relevant programmes to the need to prevent the exposure of children to environmental threats (…) …promote and encourage public health measures in areas of emerging concern about environmental impacts on children’s health on the basis of the precautionary principle.” For the Budapest conference discussions, the following Rio Declaration on Environment and Development of 1992 definition of precautionary principle was adopted “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.”
Dr. Martuzzi referred to two recent publications resulting from WHO work on dealing with uncertainty and using precautionary principle to protect children: i) A Monograph entitled “The Precautionary Principle: Protecting Public Health, the Environment and the Future of Our Children”. http://www.euro.who.int/InformationSources/Publications/Catalogue/20041119_1 and ii) A working paper prepared for the Budapest 2004 Fourth Ministerial Conference on Environment and Health – “Dealing with Uncertainty - How Can the Precautionary Principle Help Protect the Future of Our Children?”http://www.euro.who.int/healthimpact/MainActs/20030224_3
He indicated that while there is not universal agreement on the definition of precautionary principle four main themes underlie WHO’s view of the principle: i) taking action in the face of scientific uncertainty; ii) reversing the burden of proof from recipients of new technology to proponents of technology; iii) openness and transparency; and iv) analysis of alternatives. Dr. Martuzzi noted that thinking in a precautionary mindset from the outset is more likely to result in win-win solutions. He discussed the very practical needs of member states focused on seeking advice from WHO and the regional offices on two main questions: What is the evidence of health effects on environmental factor X? and What should we do? Science is the main criterion for decision-making, however Dr. Martuzzi noted that this has difficult conceptual, ethical and political implications. WHO promotes the use of all available tools including precautionary principle, precautionary approaches and other tools.
Plenary Comments
Scientific uncertainty is in the title of the workshop and I haven’t heard a definition yet. It is extremely important to establish what we mean by scientific uncertainty. The terms scientific uncertainty and precaution have been used interchangeably but they mean different things. I would encourage us to address that here. Yes I fully agree within you. I pointed out that uncertainty captures a broad series of concepts from problems of accuracy to full ignorance. I agree that it should be made clear especially when addressing specific case studies. There is a difference between uncertainty, variability of measures or variability within or between populations groups. There may be a lack of data on particular endpoints. If there is a lack of information then it’s a matter of judgment. Either we don’t know the relevance of the lacking data
6 or we don’t have data at all and are in complete ignorance. Precaution is what you do in the case of uncertainty.
2.3 Discussion of Framework Elements
2.3.1 Putting Health Issues into Context
Dr. Maged Younes of World Health Organization described the first stage of the Framework (Section 3.2), putting health issues into context, and discussed why we need to put health into context and how we put health into context in risk management decision-making.
He noted the complexity of health-based decision-making in which often there is a mismatch between knowledge and action, especially in the developing world, and involvement from a number of players and interests including researchers, business and industry, planners, the media, politicians and the public. He emphasized the importance of a sound approach to risk management that is based on risk assessment, and the need to think about what the risk management needs are in determining the extent of the required risk assessment. Difficulties arise in cases where there is a need to make risk management decisions, but there is a lack of evidence or complete ignorance. He observed that politicians and the public expect rapid clear-cut solutions, but problems are often complex and poorly understood, scientific evidence is often conflicting, and the availability and quality of data may be limited. Dr. Younes referred to the example of lead. As more epidemiological data becomes available, risk managers become less able to set a safe boundary below which there will be no effects. He discussed a number of dimensions to consider when putting health issues into context including the multiplicity of exposures through different media, different valuation of risks between societies and sectors; political and economic dimensions; and social and cultural dimensions including societal valuation of risks, equity aspects, transgenerational aspects, cultural habits and risk perception.
Dr. Younes emphasized the importance of risk perception in risk assessment and risk management and noted a number of influences on risk perception including experience, knowledge, the media, values and beliefs, confidence and trust, and characteristics of the hazard. He noted that risk managers are faced with dealing with differences between how scientists and consumers perceive risks, in which scientists may ignore the public outrage factor and consumers may pay little attention to relative nature of risks. Dr. Younes emphasized that there is always more to a risk issue than what science describes. He noted the importance of considering risk perception issues in risk management/risk reduction decisions and integrating stakeholder involvement in all stages of risk assessment to address public concerns enhance openness and transparency.
He noted the need to consider the multi-source context of environmental exposures including the multimedia context (exposures through air, drinking water and food), the multiple risk factor context (multiple exposures from the same source) and most importantly, the multi-risk context (the extent of risk due to the risk factor compared with other risks faced by the same population).
Dr. Younes identified other important issues to consider such as whether new risks will be created by introducing alternatives or through pure omissions (risk trade-offs), the extent to which those who benefit from certain activities are the same as those who bear the risks emanating from these (environmental equity) and the need to ensure appropriate risk balancing in setting priorities among multiple risks (risk balancing).
7 2.3.2 Option Generation and Assessment
Dr. John Swanson of UK National Gird Trasco summarized the provisions of the WHO Framework relating to Option Generation (Section 3.4) and Option Assessment and Selection (Section 3.5), from his perspective in being involved in the preparation of the Framework.
Dr. Swanson noted that the Framework emphasizes consideration of a broader range of options than those used in traditional risk management. Typically options have focused on limiting exposures to a particular level taking into account cost-benefit analysis. Broader options are necessary when dealing with uncertain risks and include a range of softer more flexible options, in addition to technical options. The Framework lists a variety of options including a decision to take no formal action; research; a formal monitoring process; consultation; communication and engagement programmes; labeling; reductions in exposure; banning the source of exposure; technical options (mitigation); voluntary behavioural change; and numeric standards. Dr. Swanson emphasized that the status quo is always an option that must be assessed with the same rigour as given to other options. He noted that considering the options before a technology is introduced increases opportunities for a broader range of options to be considered and in particular win- win options (for example hands-free kits for cellphones).
In assessing the options, the WHO Framework states that costs are relevant. Dr. Swanson reviewed four types of health economic analyses: cost minimization analysis; cost-effectiveness analysis, cost benefits analysis and cost utility analysis. Dr. Swanson described the human capital vs. willingness to pay approaches to valuation of health benefits and identified some of the problems that arise in using utilitarian costing to determine whether net benefits to society are worth implementation. The Framework points to a mixture of approaches taking into account societal values. It suggests weighting the analysis so that reducing risk for children and other vulnerable subgroups and from involuntary exposures are given greater weight. The Framework suggests that where IARC or a body with equivalent status classifies an agent as possibly carcinogen or that there is an equivalent possibility of causing other diseases, the benefit-cost analysis can be reasonably quantitative and objective, similar to that for a known risk. Where the classification is less than this, the option assessment may be sensibly restricted to only those options with very low costs. While cost benefit analysis is used to assess options, other principles such as those articulated in the EU Communication on Precautionary Principle need to be considered. Dr. Swanson noted that transparency and stakeholder involvement are necessary to gain commitment and trust of stakeholders and for successful implementation of any chosen action.
Plenary Comments From the health benefits side, we need solid information on exposure-response; if the risks are uncertain we don’t have information to do cost benefit analysis By definition we are dealing with uncertain risks. The Framework is attempting to say given the uncertainties how do we proceed. We have to recognize that assumptions carry uncertainties and be explicit about it. Uncertainty in exposure is one source of uncertainty and does not stop us from coming up with the best answer possible. Even if we have information for concentration- response functions it does not imply that the risk is certain. For a large fraction we don’t have epidemiological evidence, we draw from animal studies and there are huge uncertainties in extrapolating from animals to humans and high to low dose. Cost-benefits analysis remains an expert driven exercise. When you say we must involve stakeholders how do you see that happening in practice?
8 There is a move away from using experts only to include lay representation. We need to move away from the idea that you make decisions behind closed doors then go to stakeholders. There is much to be gained and it is far less threatening than we think.
2.3.3 Integrating Public Perception in the Precautionary Principle
Dr. Louise Lemyre, Professor in the School of Psychology and the McLaughlin Research Chair on Psychosocial Aspects of Risk and Health at the Institute of Population Health, University of Ottawa, presented the implications of her research on health risk perception, public trust in information sources and psychosocial aspects of terrorism for the draft WHO Framework.
Dr. Lemyre identified the following advantages of the proposed WHO framework:
Its objective is to protect population health. It poses the problem in terms of being critical, and evidence-based. It implies a time dimension (prevention, delay, evolution of knowledge, anticipation). WHO definition of health is broader than mortality. It recognizes the existence of conflicting evidence. It promotes transparency and discussion between stakeholders. It calls for action even in the case of uncertainty.
Dr. Lemyre provided several examples to illustrate the important role that heuristics play in directing decisions, behaviours and risk perceptions. She noted that experience with BSE, SARS, terrorism, and GMO foods have shown that emotions and behaviours may be the most widespread, long-lasting and costly consequences. In risk assessment and management there is a focus on characterizing the hazard. Dr. Lemyre indicated that the probability of the hazard or the threat is the active ingredient and emphasized the importance of managing the effects of the hazard as well as the probability of the hazard. She discussed results of the National Survey of Health Risks which indicated that Canadians expect regulations to be in place if the risks are not under personal control. Government was identified as the least trusted sources of information, while experts were the most trusted.
Dr. Lemyre identified three challenges for risk assessment and management under uncertainty:
1. The need to expand the notion of effects and its characterization to include risk perceptions and psychosocial impacts. 2. The need to expand the timeframe to before any occurrence of health effects. 3. The need to maintain public trust and confidence.
She described the Integrated Risk Assessment and Management Framework developed to assess and manage the psychosocial aspects of chemical, biological, radiological and nuclear terrorism for various populations, including the threat of an attack. She concluded with the notion that there needs to be an evolution of hazard-driven precautionary principle to a population-driven precautionary principle and emphasized the risk perception is an integral aspect of such an approach.
Plenary Comments As scientists if we start playing social policy we become hostages of the news media and society. There is science in the psychosocial aspects as they are observable effects. Precautionary principle under uncertainty is a balanced approach that takes into account public fears, perceptions and cost-benefit. Consultation with consumers was undertaken in BSE and the
9 safety of the blood supply. Proper application of the precautionary principle includes your points of view. Need to make it more explicit, it is there but not fully integrated. It needs to be formalized in the same way as we characterize the hazard.
2.3.4 Scientific Risk Assessment and Uncertainty
Greg Paoli of Decisionalysis Risk Consultants Inc. provided an overview of the sources, types and examples of uncertainty in risk assessment and risk management. He discussed choices in treatment of uncertainty and identified implications for the draft WHO framework.
Uncertainty enters in hazard identification, exposure assessment and exposure-consequence analysis. Paoli identified 15 processing stages in risk assessment ranging from problem selection to model development to dissemination and noted that each step involves decisions on the part of the analyst involving treatment of uncertainty in one form or another. Paoli noted that uncertainty analysis should occur at every stage in the Framework, but often only risk analysts are forced to do uncertainty analysis. The need for uncertainty analysis may be even greater for example in mitigation cost analysis. Uncertainty analysis can be undertaken for problem selection, risk assessment, risk valuation, mitigation cost analysis, decision processes, and program evaluation.
Paoli described various types of uncertainty including variability, randomness and epistemic uncertainty. Three classes of uncertainty were also described –i) model uncertainty which is the ability to describe the system, ii) parameter uncertainty which is when the phenomenon is known but is not adequately measured and is often the only source of uncertainty that is considered in risk assessment, and iii) normative uncertainty which is uncertainty in the correct way of doing things and is often left out.
Paoli reviewed various options for addressing uncertainty including ignore it, selectively include it, conduct a purely qualitative discussion; deterministic modeling but “err on the safe side”, and formal propagation of uncertainty in calculated risks. Formal methods, such as Monte Carlo Analysis, are available to characterize total uncertainty and uncertainty in the inputs. Paoli emphasized that presentation of uncertain estimates is the most critical part of uncertainty analysis and is often given the least effort by risk assessors. He concluded that uncertainty pervades the entire decision-making process and is not limited, nor even necessarily concentrated in scientific risk assessment. He noted that risk assessors and other analysts make numerous explicit and implicit choices in treating uncertainty that have tremendous and often unaudited impact on the decision-making process. He recommended that ideally, the Framework would explicitly characterize the impact of alternate risk assessment assumptions that are applied in manipulating uncertain information and would encourage informed, active choices in processing and presenting uncertain information for decision-makers and stakeholders.
Plenary Comments
There may be conservative estimates on a series of exposure factors which err on the high side, but tend to focus only on one mechanism and one exposure pathway while other pathways are not considered. The decision-maker may not know whether it is a conservative risk assessment at all.
2.3.5 Action Implementation and Evaluation
Dr. Maged Younes of WHO, described the Action Implementation (Section 3.6) and Action Evaluation (Section 3.7) stages of the draft WHO Framework. Dr. Younes provided an overview of the categories of risk management actions and described principles for good risk management decisions and principles for
10 application of the precautionary principle. The main categories of risk management actions are: i) Prevention –including guidelines/standards, specific regulations and precautionary measures; ii) Control – including emission control, environmental monitoring, occupational surveillance and health surveillance; iii) Mitigation/Remedy including reduction/prevention of exposure, site clean-up and precautionary measures; and iv) Risk Reduction –including product substitution, exposure reduction, increase knowledge, improve information, administrative and legal tools such as unilateral action by industry, voluntary agreements, technical standards, economic instruments or regulatory controls.
Options/measures should be evaluated and routinely re-evaluated against the following criteria: effectiveness, practicality, economic impact and potential for monitoring. Dr. Younes noted that the aim of the evaluation should be to prove success of the action, but also to check if, and how, the conditions (scientific evidence) that had lead to a certainty action, have changed. The following criteria for good risk management decisions were identified:
Address clearly articulated problem in its public health/ecological context Account for views of those affected by the decision Be based on scientific weight of evidence Follow an examination of a range of regulatory/non-regulatory options Lead to a reduction or elimination of risks Be implementable effectively, expeditiously, flexibly, and with stakeholder support Be shown to have a significant impact on the risks of concern Be subject to change and revision when significant new information becomes available
The following principles for precautionary principle application were also emphasized:
Proportionality: Measures should not be disproportionate to desired protection level, and not err at zero risk Nondiscrimination: Comparable situations should not be treated differently, unless objectively justified Consistency: Measures should be comparable to similar actions taken in past situations with data.
2.3.6 Legal Aspects of Using Precaution
Dr. Heather McLeod-Kilmurray, Assistant Professor in the Faculty of Law and University of Ottawa described how the precautionary principle intersects with the legal system and provided feedback on the draft Framework based on her involvement in a project for the Law Commission of Canada entitled “Practicing Precaution: Legal, Institutional and Procedural Dimensions of Scientific Uncertainty” http://www.ie.uottawa.ca/English/Research/Current_Research.htm.
She noted at the outset that the Framework adequately recognizes the importance of values and addresses the dangers of increasing discretion, reducing transparency and undermining legitimacy. These were key findings of the Practicing Precaution project.
The Practicing Precaution project found that apart from varying legal and institutional definitions of precaution, it is difficult to know what is precautionary in a given context without knowing the overall goals of a society, its attitudes toward risk, and the priority it gives to competing interests. In addition, precaution is also dependent on institutional values. Dr. McLeod-Kilmurray noted that the Framework’s emphasis on values and on case-specific development of public health policies in different contexts in Section 2.5 and Section 3.2 is very useful.
11 The essential test on judicial review is to determine whether the process for arriving at the conclusion was appropriate. Dr. McLeod-Kilmurray noted that the Framework correctly focuses on process rather than on the substance of what would be considered precaution in a given scientific context. She noted that it is important to bear in mind that a reviewing court is judging the process used against a standard of reasonableness so precautionary decisions must meet the administrative law standard of reasonableness. She suggested that the legal system could evolve to accommodate precaution and the realties of uncertainty through time limited or conditional decisions made out of respect for the need to be efficient, fair and legitimate. Dr. McLeod-Kilmurray commented that the Framework’sreference to the requirement in the EC Guidance document that measures be “subject to review” in the light of new scientific data may help to transform what is perceived as a reasonable measure or decision.
Dr. McLeod-Kilmurray noted that the Framework’s statement that “application of precautionary action should be relevant, effective, workable, socially acceptable and legitimate” captures recommendations on the important of effectiveness and legitimacy and the importance of consultation and values. She suggested adding to the Framework some suggestions for how effective and legitimate actions are to be developed, noting that the Practicing Precaution findings as to expertise, rules of participation, duties to consult etc. might be usefully incorporated in the Framework.
She commented that the importance of identifying knowledge and uncertainties is captured well in the draft Framework in Section 2.5 where the different types of uncertainty are listed and the notion of science also having a duty to identify gaps in knowledge and uncertainties and again in Section 3.3 on Risk Assessment. She recommended that decision-makers, regardless of their areas or degree of expertise, should be specifically trained in relation to precaution and how it is to be exercised in that context.
The frequent mention of communication and consultation through the Framework document was recognized by Dr. McLeod-Kilmurray as one of primary strengths of the Framework as it is a key component of all three aspects of administrative law –fairness, legitimacy and effectiveness. She noted that the Framework does not indicate whether consultation and participation should be mandatory and suggested that since the Framework states that government should be mandated to be precautionary and since participation is so crucial to precaution, perhaps consultation at the various steps should be mandatory.
Regarding burden of proof, Dr. McLeod-Kilmurray noted that the Framework suggests specifying who will be liable and this is helpful. She suggests that the burden of proof could be explicitly set out in any policy on precaution. Similarly, standard of proof can be specified in public health policies to reduce doubt and enhance the quality and reliability of precautionary measures.
Dr. McLeod-Kilmurray emphasized the importance of precision and specificity. The more policy documents and reasons for individual decisions can provide clarity and specific details on how and why a precautionary decision has been made, the better. This can be achieved through increased importance on detailed reasons and setting out explicitly various elements of valid precautionary actions such as burdens of proof, standards of proof, nature and degree of risk and nature and degree of uncertainty. She notes that details such as the list of factors for risk profiling in Section 3.2 and in Section 3.5 on Option Selection are very helpful. Specificity will also enhance the administrative law requirements of transparency and accountability which she recognized as mentioned repeatedly throughout the Framework.
Dr. McLeod-Kilmurray noted that one commentator in their workshops on practicing precaution suggested that too much precision is negative because it can prevent progress in the development of a concept of precaution, so the challenge will be to balance legal certainty and flexibility. She concluded by emphasizing the great importance of the notion of values and the Framework document’s appropriate declarations of value priorities in Section 3.3 “protection of health takes precedence over economic
12 considerations”and Section 3.5 “Priority is given to preventing risks, wherever possible, not just controlling them”.
Plenary Comments
There is still some appeal to standardization. Precautionary principle might lead us away from that. As soon as we acknowledge that each decision is context dependent and has its own unique consequences we move away from standardization. This is worrisome. We can achieve standardization through consistency in definitions of precaution in consensus on priorities and goals and can enforce these in court. We can have some differences through regulations, guidelines for pulp and paper emissions for example. For things that are case specific those are left to courts. Some standardization is good; the legal system has tools to look at differences. It was interesting to hear that aiming at precise definitions may be counterproductive. I have some difficulty with the idea that it would be good if scientists could be trained in precaution. Perhaps training was not a good word, perhaps better communication. Perhaps lawyers and judges need training. Scientists need to express and communicate what they already know on the kinds and degrees of uncertainty and what is required to alleviate uncertainty. That would make judges more confident in admitting that this is a context of uncertainty and why they reached a decision especially while decisions are time limited. Your comments on specificity are interesting. With uncertainty we have to specify. This morning we saw some formulas to use. Is there a legal definition of scientific uncertainty? Uncertainty is sometimes quantified at 50% for some issues. It depends on issues of discretion and power in making decisions. In terms of specific numbers, the legislature could specify numbers but they tend not to do that. In law we don’t require exact numbers when we know a decision is reasonable. The more scientists can be specific and quantify uncertainty this will assist judges in making decisions. The legal aspect is extremely important. WHO embarked on this process because member states started to implement policies in the name of precaution. Our aim is to bring rationality to precautionary measures. Our thoughts are starting to crystallize and the legal aspects are crucial. We are opening a Pandora’s Box, by allowing member states so much flexibility. How would you incorporate into a Framework a way to guide member states into arriving at options while avoiding misinterpretations and ending up in courts? Guidelines and policy documents are not always the most enforceable. The best you can do is indicate what the requirements will be if a decision is challenged i.e. reasonable, process elements, what would be expected in a review in court. Reasonableness, strong declarations of priorities, openly declaring that public health is more important than monetary considerations will protect decisions from legal challenge. The legal system is adapting to the need for precaution and scientific uncertainty. Scientists don’t want to hear this. Science is very rational. If we’re developing a framework where the legal system is evolving, do we have a moving target? The legal system has to determine whether something is reasonable and as values change this will change. In some jurisdictions, there may be more agreement; policy documents will be less detailed. It will vary across jurisdictions. In national courts, judiciary systems will have unexpressed values. Law does not have certainty. As more notions are accepted they will come into play in case law.
13 How important is it to incorporate in legislation the idea of allowing precaution to be incorporated into public health policy? The clearer the mandate or duty to act in a precautionary way, the easier it will be to enforce and the harder it will be to challenge. For example with the ban on cosmetic use of pesticides, given precautionary measures and international treaties, it is reasonable for municipalities to pass a bylaw. Since reasonableness is being incorporated into administrative law, even without a legal mandate, it will be more readily incorporated. The problem is what is the definition of precaution? What does it mean? WHO asks industry to act in a precautionary way, but industry says this will lead to liabilities. State in legislation..you will not be sued if you do this. Many regulatory policies will say if you meet permitted limits you will not be sued. You need to be specific about what you mean by being precautionary, it is easier to uphold. In Sweden they wanted to act in a precautionary way for power line exposures. For people living near existing power lines and a child gets leukemia, this opens themselves to litigation. In Canada, it is difficult to challenge the policy element of a government decision to regulate.If the government has decided to regulate, the court won’t interfere. The implementation is easier to challenge. The real fear is not of judicial review it’s of use of a precautionary decision in future tort action or legal liability. A precautionary action could be construed as admitting liability. If industry is sued for negligence the plaintiff has to prove breach of standard of care estimated at the time the decision was made, for example what was reasonable within industry at the time the power lines were installed? In a personal injury case in the US, there is the fear that a jury would be swayed by emotion, lead by a clever council.
2.3.7 Plenary Discussion of Framework
The following comments were made by delegates in plenary discussion:
When does weight of evidence override scientific uncertainty? Science has been using weight of evidence approach for some time. Science should indicate where the uncertainties are. By looking at weight of evidence, the uncertainties are implicit. WHO has a fantastic database on health effects of EMF. There are a huge number of studies, but there are still gaps in evidence. The issue has continued because they perceive they are at risk. We look at the key issues and evaluate evidence as best we can. Technology is moving so rapidly. The Interphone study in 13 countries is studying analog and first generation digital phones, we’re not looking at third generation digital. One way to avoid uncertainty is to create standards for research whereby EMF studies are planned under the same protocol. Until this exists the reviews of numerous studies of effects on the immune system will be difficult as no two papers use the same approach. In the WHO project many research agendas have identified areas that still need to be confirmed. We have no information or studies that have some information but is different from what we believed (i.e. blood brain barrier studies). The problem is that findings could be due
14 to a flaw in the methodology, but gets publicity and challenges the conventional view of scientists. Trying to pull the studies together using a weight of evidence approach is the only way to overcome the problem. Looking at the way research is done is a research policy issue. If research was done with the aim of regulatory policy decisions in mind we would need a multi-centre study looking at quality control etc. In the chemical and pharmaceutical industry appropriate testing is required before release of a product. It is not required for cell phones with new modulations. Why are they not regulated in a similar way as the chemical industry where appropriate tests need to be done before a product is released? Technology is moving along rapidly and there are huge benefits then we ask the question is it really safe. In addition to the standard we need precaution in public health policy. We’ve got a standard based on the available science and we need a complementary tool to act in a precautionary way to keep levels down until we get more information. We don’t have standards for nonthermal effects. That’s why countries are moving ahead with their own guidelines. I don’t see WHO as leading in this area. Thermal standards are still used in most countries. I disagree that we have appropriate standards. They are only for a small range of thermal effects. The science has been looking at nonthermal effects for over 10 years. Standards are only based on health effects but not biological effects. There are clear methods for developing standards that are evolving. We’ve got the best science we have in developing standards and they are subject to review. If anything untoward is coming out, we will look at the standards to ensure that all people are protected to the same level. WHO has been looking at thermal and nonthermal events including increases in stress for laboratory workers and other people exposed to radiation. Stress in an important non-thermal effect. We have to think twice when we say technology is getting away of risk assessment. Unless we understand frequencies and modulations we may be misleading the public. The interphone study is a 13 country study of cancer risk related to cell phones. WHO designed the study for sufficient power of sensitivity and exposure ascertainment. The interphone study has finished 5 years of field work and focuses on older digital and first generation digital phones, but will provide useful information because should studies show no increase in risk this will be the case for newer phones. Because modulations have been changing we have to look at whether modulation matters. If we use scientific principles, modulation at the levels in current cell phone doesn’t seem to matter. A number of publications indicate that this is the case. Because technology is changing we’ve got to look at modulation as an aspect of exposure. We’ve got a lot of exposure data but we don’t know what aspects of exposure that matter. Modulation at the levels of mobile communication doesn’t seem to matter.
3.0 Case Studies to Test the Framework
A series of eight case studies were presented by various organizations to illustrate aspects of the risk management decision-making process for EMF, BSE, food safety (GMO), climate change, pandemic influenza, radon, Walkerton and MMT.
15 3.1 Electromagnetic Fields
Dr. Michael Repacholi of WHO presented the case of electromagnetic fields (ELF and RF fields) to illustrate the WHO policy framework. He identified several factors that trigger public outrage including uncertain health effects such as cancer; health effects in children; the involuntary, and invisible and ubiquitous nature of exposures; and the inequitable distribution of benefits. The rapid introduction of new EMF emitting technologies presents a challenge for the scientific evaluation of safety.
Dr. Repacholi discussed the EMF issue within the context of each of the stages of the WHO Policy Framework. IARC in 1992 identified ELF magnetic fields as possible carcinogenic (2B carcinogen) based on evidence for childhood leukemia and electric field as 3 “unclassifiable “ for electric fields based on evidence for other childhood cancers, adult cancers and other health outcomes. The 2B classification for magnetic fields warrants thorough consideration of precautionary measures with detailed cost-effective analysis. For electric fields under the framework consideration of precautionary measures are limited to low cost interventions, if any.
Sources of exposure include transmission and distribution circuits of electricity, wiring in buildings (homes and schools), domestic applications and electric transport systems. Epidemiological evidence suggests a RR of 2 for long term average yields in home of 0.4 µT or more. There is uncertainty whether the epidemiological evidence reflects causality or not. These uncertainties arise from the possible biases in the effect estimate or confounding or misclassification biases. Also there is an absence of supporting evidence from in vivo and in vitro studies. Key uncertainties in assessing the risks are associated with metrics of exposure, exposure-response relationships and uncertainty regarding the relevant exposure periods and duration-response relationships.
Dr. Repacholi identified a number of possible precautionary measures for ELF and noted that the options selected will vary from country to country. Measures include do nothing, research, communications, engineering measures, planning measures and exposure limits. Cost-effectiveness analyses of the options should be undertaken comparing the effectiveness of a measure with alternative ways of achieving a similar benefit. This should incorporate uncertainty in causality and exposure; the full range of costs, both financial and non-financial; any redistribution of the burden of exposure; the incidence of childhood leukemia and fraction potentially attributable to magnetic fields; and the number of children a given measure would benefit.
Dr. Repacholi presented relevant factors to consider in estimating benefits and costs for each option. Precautionary measures such as voluntary codes, encouragement and collaborative programs were identified as most appropriate. Stakeholder involvement including government, industry (electricity, appliance manufacturers, academic and citizen groups, planners, school officials, and real estate professionals) is important. Activities under Action Evaluation include monitoring compliance or update, monitoring health effects (cancer registry), and monitoring scientific information. Dr. Repacholi noted that the process has to be iterative.
On the issue of RF fields from mobile technology, Dr. Repacholi identified a number of factors relevant to the health context. RF technologies are rapidly evolving with different exposure situations; there are an increasing number of mobile phone users; exposures are close to the body; there are an increasing number of children using mobile phones, there are an increasing number of base stations with 24h/day exposures; and there is public concern about the health consequences of long term RF exposures. Mobile phone networks are replacing land line systems in developing countries.
Dr. Repacholi reviewed the characteristics of exposure for radio and tv broadcast transmissions (continuous population-wide low level exposure for many decades), cellular communications
16 infrastructure (continuous population-wide low level exposures, of varying strength, growing over one decade) and cellular communications handsets (large number of relative high individual exposures, principally to the brain, approaching ICNIRP exposure guidelines during use of device). Public concern about base stations has continued for several years in some countries.
Dr. Repacholi discussed the main findings of risk assessments noting that peer reviews of science have not indicated health consequences below international guidelines. There are insufficient studies to ensure the safety of children. The likelihood that mobile phones cause cancer or effects on mental functioning is probably small, but cannot be ruled out.
In terms of options, Dr. Repacholi noted that assuming evidence for cancer from RF is below an IARC 2B classification (unlikely to be carcinogen to humans), and since other health effects have not been established, only very low cost or no cost interventions can be considered. He discussed several precautionary measure options. The do nothing option is not popular with a concerned public and may be expensive if the issue becomes political. Research is needed to reduce uncertainty but at what level? Communications are essential to maintain public confidence and might include SAR levels. Engineering measures include enforcement of existing requirements to keep people away from antennas, and hands free kits. Planning measures include locating EMF radiating structures away from people. Dr. Repacholi noted that exposure limits should not be lowered arbitrarily in the name of precaution. Examples of precautionary approaches in other countries include the prudent avoidance approach used in Sweden, Australia and New Zealand consisting of using ICNIRP values with low cost measure to reduce exposures; As low as technically achievable (ALATA) approach used in Switzerland consisting of using ICNIRP values and minimizing emission levels, while in Italy, Greece and Belgium lower ICNIRP values have been established using arbitrary factors.
In terms of option assessment and selection cost-effectiveness, uncertainty as to any health effects suggest the need to keep exposures as low as possible at no or very low cost. The full range of costs of each measure such be reviewed including financial and nonfinancial costs and any redistribution of the burden of exposure. Actions selected should have legal certainty and predictability.
Dr. Repacholi noted that voluntary codes are used frequently for base stations. Action evaluation includes monitoring compliance, monitoring health effects through cancer registries etc. and monitoring most recent scientific information.
3.2 BSE Risk Management
Dr. William Leiss, Scientist at the McLaughlin Centre for Population Health Risk Assessment, University of Ottawa and Emeritus Professor in the School of Policy Studies at Queen’s University presented a case study on the management of BSE risk in North America to illustrate the consequences of not being sufficiently precautionary. He identified three different types of risk in this case –the risk to animal health, the risk of contracting nvCJD by eating beef infected with BSE, and the economic risk to beef exporting countries such as Canada associated with even a single case of BSE.
Dr. Leiss noted that Canada failed to recognize the significant economic impact of one or a few cases of BSE in the Canadian herd. Canada is one of 24 countries that subscribe to a policy that prohibits imports if there is one single indigenous case of BSE in a national herd in the last seven years. In 2004, the OIE adopted new rules allowing countries to designate themselves “at minimal risk” if they have no more than one indigenous case of BSE per million cattle, however for Canada the damage had already been done. The economic costs are estimated at $8 billion after four cases of BSE as well as devastating personal and family costs to farm families, especially in Western Canada.
17 Dr. Leiss noted that Canada’s quantitative risk estimation was not completed until early 2003 which was too late to have been useful in risk management policy. Further, he noted that the risk assessment failed to include a quantitative estimation of the economic impacts associated with introduction of BSE in Canada. The US economic profile is different from that of Canada because it consumes 90% of what it produces and exports only 10%.Prior to May 2003, Canada was exporting 75% of what they produced. Dr. Leiss noted that this is why the risk assessment must integrate all relevant factors (economic as well as human and animal health) in the risk analysis.
Dr Leiss noted other examples of the lack of proper precaution, including shortcomings in the 1997 partial ruminant feed ban, lack of proper disease surveillance policies, lack of proper scientific analysis, and lack of adequate levels of testing for BSE. Dr. Leiss concluded that there is clear evidence in the BSE case that, despite the nominal commitment to the ‘precautionary approach” in Canada, it has not been implemented in important areas of policy and regulation resulting in significant damage to the Canadian economy and the farm sector. He referred to his recent paper with Steve Hrudey that discusses how much precaution is justified by the evidence and the uncertainties (http://www.leiss.ca/articles/126).
Plenary Comments
When is it appropriate for an academic institution to play a role in risk analysis, what are the benefits and concerns? In general this type of work is ideally offloaded to independent research centers. Government officials have little time to look ahead. Length of time is critical as you may lose the advantage that you might have had should you have been more precautionary. There is evidence that it can be done well and quickly. Health Canada is involved in risk assessment. Regarding more precaution, in order to be more precautionary you have to consult with stakeholders.What about farmer compliance? Canada had information on BSE risk. The fault lies with CFIA in not choosing a different course of action to be more precautionary and provide more advice to beef farmers to restrict growth unless OIE policy changed, which it did. Was the Privy Council framework introduced before or after this incident? It was during. In the late 90s and early 2000 the federal system was trying to get system wide articulation of the precautionary principle. Documents were issued in the early 2000s but did not provide enough direction on how to apply it. There is no guidance on when to use precautionary principle, how to decide how precautionary to be and how to justify the costs and it is badly needed.
3.3 Genetically Modified Foods Risk Management
Dr. Peter Karin Ben Embarek of World Health Organization presented an overview of the genetically modified food issue, how food safety is assessed and how science, fears and uncertainties are balanced. He noted that there has been an increase in genetically modified crops in both developed and developing countries. Food safety is an international concern considering that there are 1.8 million deaths per year as a result of foodborne or waterborne diarrhea in developing countries and 30% of the population in industrialized countries develops foodborne diseases. He noted that trade issues are of tremendous importance in making decisions to manage risk. In recent years, food production has become strategically important in developing countries. Due to the globalization of trade, it is extremely important to be able to trace the origin of products at a later stage and have continuous evaluation of safety.
Dr. Embarek noted that managing food safety involves balancing science, public health consumer confidence, trade, politics and communication. The traditional framework for risk analysis in food safety involves the process of risk assessment and risk management through an iterative process with risk communication applied throughout the process. In the food area, risk assessment is provided by WHO
18 and FAO while risk management such as the development of guidance, standards, regulations and criteria is done by the Codex Alimentarius Commission which is an international food standards organization set up by FAO and WHO in the 1960s.
The Codex has tried to define and enshrine precaution in the development of food safety standards through the requirement for precaution to be inherent in risk analysis and the requirement for explicit consideration of uncertainty and variability in risk analysis. Where there is sufficient evidence to allow Codex to proceed to elaborate a standard, the assumptions should reflect the degree of uncertainty and the characteristics of the hazard. Dr. Embarek discussed two emerging issues: acrylamide which is a new hazard in a wide range of foods (french fries, coffee, bread, baked foods..). Within two months expert consultation provided a rapid assessment and interim guidance on use of a balanced diet and limited consumption of high risk foods. Despite large uncertainties, precaution was used in a rational and balanced way. There is a need to balance long term potential health risks with rational short term decisions. Regarding the food safety aspects of avian influenza, a rapid assessment and guidance on food safety measures were available within two weeks. Based on a gambling analysis of many governments, measures to minimize potential catastrophic impact due to mutation of viruses have so far not been taken. Underlying this decision is the belief that this will not happen.
Dr. Embarek discussed public perceptions of GM food production noting that differences between peoples’ perceptions of the use of gene technology in medicine and in GM foods seem to indicate that factors other than health risk considerations are at play. He noted that people are not for or against GMOs as they react more to the context in which GMOs are developed. Dr. Embarek describe the legal framework provided by the WHO/SPS agreement which provides international agreement on how sanitary rules should be applied in the food trade based on internationally accepted risk assessment requirements. Codex adopted a series of principles for risk assessment of GM foods looking at direct effects and unintended effects. For direct effects, a premarket case by case risk analysis is required for each new GM food. Long term post market monitoring and surveillance is conducted to assess unintended effects Dr. Embarek noted that little is known about the long term effects of any food, making the identification of effects that might be unique to GM foods problematic.
Dr. Embarek concluded that GM foods currently available on the international market have passed risk assessment and are not likely to present risks to human health. However the long term risks are more uncertain and warrant holistic evaluations which go beyond human health and environmental effects to include benefits, nutrition, socio-economic aspects, ethical aspects, access and equity and property rights.
3.4 Climate Change Risk Assessment and Management –An Economic Perspective
Dr. Philippe Crabbé, Professor Emeritus at University Ottawa, presented an economic perspective on the climate change issue. He noted that economists do not know the price of everything and use optimization models to derive missing prices. Economists include anybody who subscribes, at least in part to the utilitarian ethics, e.g. benefit cost analysis. Dr. Crabbé noted that the costs of climate policy are incurred up front while benefits are reaped much later.
The UNFCCC calls for stabilization of GHG concentrations in the atmosphere at a level that would prevent ‘dangerous’ anthropogenic interferences with the climate system. Dr. Crabbé referred to the Copenhagen Consensus which determined that climate change is at the bottom of issues related to UN Millenium Goals, with costs likely to exceed benefits. He noted that stabilization of concentrations is elusive because climate is a dynamic, non-linear system with different possible equilibrium concentrations. Climate is subject to large uncertainties and there may be techno-economic constraints preventing stabilization. Accordingly, risk hedging strategies will be required including adaptation to reduce impacts and financial risk sharing as well as hardware, software and orgware strategies. Dr.
19 Crabbé noted that robustness and resilience are the best current strategies, but must be examined in the context of other stresses. He concluded that risk assessment and management is a useful overall framework for involving stakeholders and for managing uncertainties.
3.5 Pandemic Influenza
Dr. Paul Gully, Deputy Chief Public Health Officer of the Public Health Agency of Canada presented an overview of precautionary options and other issues related to the management of pandemic influenza. He noted that influenza pandemics have occurred without warning leading to social and economic disruption, illness and loss of life. Knowledge of opportunities for risk mitigation and public expectations are greater than at the time of the last pandemic. BSE, West Nile Virus, and SARS have created this expectation. In the past, vaccines were the most important intervention and were available for the last pandemic, but too late to have an impact. Anti-virals were not available.
Dr. Gully identified several possible warning signs of an Avian influenza pandemic. H5N1 is now endemic in bird populations in Asia. Avian outbreaks continue to occur despite aggressive control measures, including the culling of more than 140 million poultry. Migratory birds are dying with highly pathogenic H5N1, but domestic birds excrete large quantities of highly pathogenic virus without showing signs of illness.There are unprecented levels of transmission to humans. The evolution of the risk is unpredictable and the early warning system is weak. Interventions to reduce risk to humans and associated mortality and morbidity are possible but untested. The information base from which to make decisions is limited.
Dr. Gully identified a number of precautionary options including i) reducing opportunities for human infection through collaboration between animal and human health sectors, risk communication and modeling of the virus emergence; ii) strengthening the early warning system by improving the detection of cases, investigating human cases related to animal outbreaks, epidemiologic investigation and strengthening risk assessment; iii) containing or delaying the spread at source through international anti- viral stockpile and delivery mechanisms; and iv) reducing morbidity and mortality and social disruption through monitoring the evolution of the pandemic, non-pharmaceutical interventions, use of anti-virals for priority groups, augmenting vaccine supplies and delivery, and risk communication.
The choice of options takes into account social factors, ethical values, experience, observation and modeling. Stakeholders need to be identified at the country level, local level, and individual level. The question of inequitable distribution of risks, the capacity to respond, and inequality of access to antivirals are important considerations. Options currently in place include research, monitoring, consultation, communication and engagement, and behavior change. Options at the time of a possible pandemic include pandemic alert declaration, promotion of behavioural change (social distancing), reduction in exposure (possible border closures, possible quarantine); and technical mitigation (antivirals and vaccines). Evaluation of options will be dependent on surveillance, investigative and risk assessment infrastructure. The need for changes to utilization of antivirals, vaccine and other measures will require evaluation.
Dr. Gully commented that the Framework is useful in identifying a fundamental decision point where the precautionary principle will be applied in the “declaration” of a pandemic. This will trigger a public health response, but will also trigger a societal response which is unpredictable. The evaluation phase will be important to analyze the benefits of antivirals and quarantine and need for changes in the response.
3.6 Radon Case Study
Dr. Daniel Krewski, Professor and Director of the R. Samuel McLaughlin Centre for Population Health Risk Assessment described the scientific evidence and uncertainties associated with residential radon
20 exposure and lung cancer risks. Radon is formed from decaying uranium-238 which emanates through the earth’s cracks and fissures and is distributed through indoor air. Eleven international epidemiologic studies of underground miners consistently indicated an excess risk of lung cancer associated with radon exposures. This data was the primary source of information leading to IARC’s identification of radon as one of 93 causes of lung cancer.
In 1980, a cross-Canada radon survey of 18,000 homes identified Winnipeg as having the highest levels in the country. A case-control study of residual radon and lung cancer risk in Winnipeg undertaken during 1983-1993 and published in 1994 (Létourneau et al., 1994) indicated no increase in lung cancer risk associated with cumulative exposure to radon among the cases. In 1999, the US National Research Council released the BEIR-VI report on the health risks of radon which concluded that radon is responsible for 10-15% of all lung cancer deaths in the United States. A combined analysis of seven large scale North American case control studies (Krewski et al., 2005) and combined analysis of thirteen European case control studies (Darby et al., 2004) supported a positive association between residential radon exposure and lung cancer risk. Lung cancer risk associated with radon exposure in Canadian homes has been estimated at 13% (lifetime relative risk) and 10% (population attributable risk)(Brand et al., 2005). The relative risk and attributable risk are higher among non-smokers.
A Health Canada workshop examined residential radon guidelines in various countries. Canada has one of the highest action levels (800 Bq/m3) for existing and new homes. This is currently under review by the Committee on Environmental and Occupational Health.
Dr. Krewski reviewed studies of the cost-effectiveness of radon screening options. Based on an action level of 200 Bq/m3 and a discount rate of 5% per year, screening all current homes was estimated at an incremental cost $62,636 per QALY gained compared to $76,615 per QALY gained to screen all current and new homes. A Willingness to Pay study conducted in Winnipeg indicated that Canadians are not willing to pay to reduce exposures until levels reach 1,120 Bq/m3, well above the Canadian Exposure Guidelines of 800 Bq/m3. However, when advised of the Guideline, they were willing to spend money to take action at 702 Bq/m3.
Dr. Krewski described WHO's residential radon program (2005-2008) which will establish a worldwide database on residential radon levels, radon action levels, regulations, and research institutions and authorities. In addition it will provide public health guidance for awareness raising and mitigation and establish the global burden of disease associated with residential radon exposure.
Dr. Krewski reviewed ten principles of risk management decision-making identified through a review of risk management frameworks for human and environmental risks conducted for the Federal/Provincial/Territorial Committee on Environmental and Occupational Health (Jardine et al., 2003). Two of the principles: i) Seek optimal use of limited risk management resources; and ii) Be cautious in the face of uncertainly, have particular relevance to precautionary actions. Dr. Krewski indicated that there are at least fourteen different definitions of precautionary principle currently in use and noted the need for a cohesive description of what it is and how it can be used.
Dr. Krewski concluded by identifying four main uncertainties in radon risk management: global indoor radon concentrations, global burden of disease, cost-effective radon guidelines, and communication of residential radon risks.
3.7 MMT in Gasoline
Dr. Claude Viau, of the University of Montreal presented a case study on precautionary principle and MMT in gasoline on behalf of Dr. Joseph Zayed of the Department of Environmental and Occupational
21 Health at the University of Montreal. Dr. Viau noted the distinction between precaution and prevention as the two principles are often confounded. Precaution is related to potential risks while prevention is related to known risks.
MMT is an antiknock agent that has been used in unleaded gasoline in Canada since 1976 to replace tetraethyl lead. Dr. Viau reviewed the historical background of MMT in Canada. U.S. EPA determined that theoretically, atmospheric manganese concentrations could double with an intensive use of MMT. In Oct. 1995, EPA granted Ethyl’s waiver to use MMT in USA. In 1997, the Government of Canada banned both inter-provincial trade and importation of Mn-based substances including MMT. In July 1998, the Canadian government reworded this law so that manganese-based fuel additives were not included in their restrictions. The use of MMT is spreading to many countries (e.g. Australia). In 2003, Canada adopted Bill C-258, the Automotive Pollution Reduction Act to protect human health and the environment which eliminates the gasoline additive MMT. The Preamble to Bill C-258 notes the following “Whereas there is a growing body of scientific evidence that human health and the environment are harmed or may be harmed by gasoline containing MMT ….And whereas on the basis of the precautionary principle, it is imperative for the parliament of Canada to take immediate action to protect human health… Dr. Viau noted that India has recently decided to not use MMT on the basis of the precautionary principle.
MMT combustion products are in the form of airborne particles with mass median diameter between 0.2 to 0.4 µm. There is a correlation between atmospheric Mn and traffic densities. Atmospheric MfR concentrations regularly exceed USEPA reference concentrations. About 100 000 kg/y of Mn from MMT sources is emitted in the Canadian environment. MMT is unstable in light and does not degrade as rapidly as claimed.
Dr. Viau identified a number of scientific uncertainties: i) There is incomplete knowledge of environmental fate of MMT and associated chronic human exposure; ii) There is no reference concentration (RfC) for MMT; iii) The actual impact of MMT on CO and NOx emissions is unknown; iv) The relative contribution of MMT to atmospheric Mn and resulting human exposure is unknown; v) the health risk related to environmental chronic exposure to MMT derived Mn is unknown; vi) the economic impact of MMT; vii) toxicity related to different Mn species resulting from MMT combustion; viii) the toxicity related to particle size, focusing on nanoparticles iv) specific toxicity related to the olfactory route; and v) extrapolation from animals to humans.
Dr. Viau raised two questions: Should we apply the precautionary principle? He noted that apparently the Government of Canada decided yes the potential harm is severe enough. What should be the role of stakeholders?
Dr. Viau shared his own views. In areas of increased potential harm and increased uncertainty, application of precautionary principle would be considered. It depends on social considerations, risk tolerances, and economic considerations. If uncertainty is low and potential harm is high, a classical risk-based decision would be taken. Where the potential harm is minimal and increasing uncertainty, a risk-based or political decision decision would be taken.
Dr. Viau described a decision-making framework for identifying situations in which precautionary decisions are taken. Following a trigger point, a scientific assessment of harm and uncertainty around data is conducted to make a decision. The information is passed to decision-makers. If they understand the information conveyed by scientists they will make a defensible decision and acknowledge the scientific contribution which leads to increased trust between the public and decision-maker. Where information is poorly or incorrectly understood this leads to poor decisions and loss of trust and further decreases risk tolerance. This increases the incentive to use precautionary principle. Dr. Viau noted that it
22 is important for decision-makers to seek clarification of science and not view it as a one way street. There should be interaction between decision-makers and scientists. Scientists have a duty to use lay person language. Scientists should be taught how to communicate with lay people.
3.8 Walkerton Case Study
Dr. Kim Vicente, Professor of Mechanical and Industrial Engineering at the University of Toronto discussed the May 2000 E. coli outbreak in Walkerton to illustrate the importance of understanding the interaction between multiple levels of the public health system to ensure safety. He presented a framework for understanding public health systems from a sociotechnical systems perspective. He noted that the complex nature of public health systems which are characterized by technological complexity, rapid pace of change, potential hazards and scientific uncertainties require a systematic approach to guiding decisions.
One of the weaknesses of the Proposed WHO Framework noted by Dr. Vicente is that it describes a process or a sequence of stages for how to make decisions, but is missing the description of the structure of the system. He indicated that political, environmental, social and economic factors are mentioned in the Framework document, but their role in public health decision-making is not emphasized. He proposed Rasmussen’s (1997) Framework as a complementary tool, as it looks at safety from theperspective of the dynamic interaction between governments, regulators and associations, companies, management, staff and work.
Dr. Vicente indicated that the Walkerton E. coli outbreak resulted in 7 deaths, 2300 illnesses and lasting health effects. The economic impacts are estimated at more than $64.5 million CAD. Dr. Vicente presented a conflict map to illustrate his analysis of the interaction between the following failures at various levels of the water safety system: i) Provincial level: an antiregulatory culture and budget cutback: ii) Provincial Regulatory Bodies: inadequate coordination and failure to act on information about vulnerability of the water supply; iii) Local Government Level: lack of legal requirement to report adverse lab results to provincial authorities, lack of clear role for local health units in responding to water quality reports, inadequate follow-up to repeated findings of poor water quality, misplaced trust in competence, commitment of Walkerton PUC management; iv) Technical and Operational Management Level: reluctance to invoke emergency plan, and willful deception and misoperation of Walkerton water system; v) Physical Processes and Actor Activities: inadequate understanding of risks to public safety; and vi) Equipment & Surroundings: Lack of chlorinator on Well 7 and lack of continuous monitors on Well 5.
Dr. Vicente concluded that vertical integration of all levels of the public health system is critical to safety. To achieve this, there is a need to look at the structure and dynamics of all levels of the public health system as well as the overall decision-making process.
4.0 Stakeholder Perspectives on Precaution
Ken Ogilvie, Executive Director of Pollution Probe provided an ENGO perspective on the precautionary principle. Pollution Probe’score mission is research, education, and advocacy. It was formed more than 30 years ago as a student movement at the University of Toronto and is supported today by 7,000 active members. Pollution Probe has been involved in the precautionary principle issue since 1999, participating in Government of Canada consultations on policy guidance in applying the precautionary principle and preparing several reports on the application of precaution to standard setting, environmental decision-making, and children’s healthin Canada.
23 Mr. Ogilvie identified the following critical aspects of the precautionary principle from the perspective on ENGOs: Use of the Wingspread definition of the precautionary principle ("When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.") Reverse onus of proof for industry whereby the proponent of an activity, rather than the public, should bear the burden of proof. Policy bias towards use of the “least risky alternative” Use of cost-effectiveness criterion in deciding upon alternative measures (as opposed to cost-benefit criterion) Precautionary ‘science’ and weight of evidence to be used in decision-making Transparency of both information and the decision-making process Public involvement (engagement) in all stages of the risk assessment/risk management process (e.g. to ensure that risk assessors ask the right questions)
In general, ENGO concerns about ‘science’ are the following: who does it, who pays for it, who decides what is to be studied, and who interprets the findings for the public, and who communicates research to the public and policy-makers?
Ogilvie described Pollution Probe’s involvement in the New Directions Group (NDG) Precaution Project and aspects of the dialogue between NGO’s (health and environmental groups) and industry within this forum. The NDG is a forum for business and NGO leaders to discuss sustainability issues. The precaution project was initiated in response to shared concerns as well as differences in views between industry and NGO about how precaution should be applied in a Canadian context. The NDG discussion was focused on applying precaution in risk-based decision-making processes. The NDG precaution team concluded that standard or traditional RA/RM is fine when there is little scientific uncertainty or controversy as it already integrates precaution. However, precaution is triggered by the introduction of new products or technologies, new information on existing products or technologies, or significant public concern that warrants action by a government or a corporate decision-maker. The manner in which precaution influences and is integrated into risk-based decision-making is important since, without clear guidance, the concept can be either abused or subverted. The lack of a predictable (or at least understandable) process for applying precaution leads to a lack of trust in final decisions. The NDG precaution team identified the following 3 decision-making “tracks” preceded by a preliminary screening stage to decide on which track a specific issue should follow:
Track 1 is a standard RA/RM process with a little risk or scientific uncertainty. This should result in a more streamlined risk assessment stage and related risk management measures. Track 2 is an alternative approach to RA/RM to be used to deal with ‘hot’ issues such as some reproductive technologies, or as a proxy for a broader societal debate around new products or technologies for which supporting science may be in its infancy. This track would still need to be grounded in the best available science. Ogilvie noted that Canada could benefit greatly from having a National Academy of Science (as in the U.S) to provide independent advice on scientific matters. This track would be applied in exceptional circumstances. Track 3 is a negotiated RA/RM track that would be used when potential risks or benefits to society are considerable and the level of uncertainty is high. The key characteristic of this track is enhanced stakeholder involvement in decision-making.
24 Oglivie commented on the potential for industry and NGO agreement on various concepts underlying a precautionary approach. There is general agreement on: i) issue characterization, or how best to design the decision-making process; ii) consideration of alternatives; iii) reverse onus of proof (only in selective cases) and iv) transparency of decision-making process. There is significant disagreement on i) having a policy bias towards the use of the least risky alternative and on the use of cost-effective criteria in choosing among alternative products or control measures ii) duty to act –industry preference is to use cost-benefit analysis to decide on ‘need to act’ and extent of precautionary action warranted.
Ogilvie concluded with the following comment on the proposed WHO Policy Framework:
“If the application of the Framework does not lead to a reduction in the risk of damage due to EMF exposure (especially to children), then it will not be accepted by ENGOs (and possible by many health-based NGOs). It will not be consistent with what ENGOs consider to be the proper application of the precautionary principle.”
Geoff Granville, of Shell Canada reviewed the Privy Council Office (PCO) Framework for the Application of Precaution in Science-based Decision-making about Risk (http://www.pco- bcp.gc.ca/docs/Publications/precaution/precaution_e.pdf) and discussed the application of its principles to chemical risk management. Granville noted that the application of the framework to the management of toxic chemicals is highly relevant in light of recent actions to categorize/screen DSL substance categories for greatest hazard and speed of assessment.
The following five general principles of application outline distinguishing features of precautionary decision-making: i) The application of precaution is a legitimate and distinctive part of risk management; ii) It is legitimate that decisions be guided by society’s chosen level of risk protection; iii) Precaution must be based on sound science information/evaluation, which evolves over time; iv) Mechanisms for re- evaluation should exist; and v) A high degree of transparency, accountability, public involvement are required.
Five general principles for precautionary measures are identified in the PCO Framework that describe specific characteristics that apply once a decision has been taken that such measures are warranted: i) they are subject to reconsideration; ii) they should be proportional to severity of risk being addressed, plus society’schosen level of protection; iii) they should be non-discriminatory and consistent; iv) they should be cost-effective and efficient; and v) if multiple options meet the above characteristics, the least trade restrictive measure should be applied. Granville noted that these themes are appropriately reflected in the draft WHO Framework document.
He reviewed a number of key PCO Framework principles such as the importance of credible peer reviewed scientific information capturing a variety of scientific sources, perspectives and disciplines to enhance credibility of and trust in decision-making. Granville referred to the EU industry position on a recent ban of 3 phthalate plasticizers in children’s toys which emphasizedthe potential risk to children’s health associated with forcing manufacturers to use alternatives for which the risks are less well known.
Granville noted that the concept of precaution forces scientists to address philosophical issues directly. A risk management or decision-making framework is vital to ensuring a good decision-making process. Scientists must remain acutely aware of the need to provide clear language summaries of what is known (e.g. assumptions, science uncertainties, safety factors used) in order to provide clarity around the ‘science input’ to a decision. Granville noted that the PCO document provides good guidance to allow precaution to be given appropriate weight.
25 He concluded with the following observations on needs for the WHO framework: i) careful and consistent definitions (i.e. risk analysis) ii) precaution (however defined) must exist within a decision-making framework not outside of it iii) discussion of science vs. values should be more thorough and iv) discussion of benefits must be at a higher level where appropriate (go beyond benefit-cost analysis and cost-effective analysis).
Dennis Erpelding, of Elanco Animal Health, provided a perspective from the animal pharmaceutical industry on advancing public health, food safety, animal health and animal welfare in areas of scientific uncertainty. He examined scientific uncertainty in relation to the question “to what extent does antibiotic resistance in food animals contribute to bacterial antibiotic resistance in humans”? He emphasized the importance of assessing both risks and benefits using a holistic approach that considers global impacts. He discussed the adverse impacts of banning the use of growth-promoting antibiotics in food animals in Denmark to illustrate the adverse societal impacts of decisions based on precautionary principle.
Current approaches to regulating antibiotics address scientific uncertainty through stringent regulatory criteria for drug approvals and strict specification for usage. The transfer of antibiotic resistance requires several steps beginning with antibiotic use in animal, development of resistant animal bacterial strain, survival through food processing and preparation, colonization in humans, onset of disease and treatment failure. Erpelding noted the following global impacts of the ban in antibiotic growth promoters in Denmark: increase in diseased and dead pigs, increases in therapeutic usage of antibiotics, increases in human campylobacteriosis cases, and decreases in global food abundance. He referred to studies noting the important prophylactic activity of antibiotic growth promoters for animal health as their withdrawal is associated with a deterioration in animal health (Casewell et al., 2003). Similarly, a WHO report noted no serious negative effects, but significant increases in animal death and sickness, significant increases in therapeutic antibiotic use and no discernable public health benefits, except a precautionary reduction in the threat of resistance. Erpelding noted that the quantified risk to humans of acquiring a resistant infection ranges from less than one in 14 million people per year to less than one in 29 billion.
He concluded with the observation that the framework for scientific uncertainty is seriously flawed as global public health policy needs to be assessed in a holistic manner based on a balancing of risks and benefits. He noted that precautionary principle has adverse risks to society and that affluent societies, in particular, need to consider impacts on societies with less abundance. Societal acceptance of reasonable risks in areas of scientific uncertainty has global benefits. A trusted and transparent regulatory process is critical.
Dr. Jack Rowley, Director of Research & Sustainability at GSM Association discussed the application of the Draft WHO Framework to radiofrequency fields. He noted that the June 2005 draft WHO Framework is a significant improvement from the October 2004 version in the following ways: i) there is a greater emphasis on the scientific basis for actions; ii) the document notes that the goal is not a ‘risk-free’ world; iii) it notes that decisions taken in the name of precaution may increase concern; iv) there is greater clarity regarding uncertainty; and v) there is more consistent terminology.
In terms of needed improvements, he indicated that the document assumes a link between exposure and public concern and provides little guidance for member states on prioritization in order to determine how much to invest on risk characterization for various risks and agents.
Dr. Rowley discussed the variety of applications of radiofrequency energy including communications/broadcast, domestic, industrial, medical, and telecommunications. Typical radiofrequency exposures are very low relative to recommended exposure levels (ICNIRP Guidelines), with the dominant population exposures coming from broadcast sources. Dr. Rowley indicated that from a scientific uncertainty perspective, the consensus of many international expert reviews is that there is no
26 convincing evidence of a health risk at exposures below the recommended levels in international guidelines. Therefore, RF signals constitute an agent where there is less uncertainty among expert groups than in the perception of the public. Specific to RF issues, he noted that recent research has shown that precautionary policies may increase public concern and recommended that these concerns would be best addressed through information and trust building measures rather than unscientific precautionary controls on exposure levels. He concluded that new technology is not always dangerous and suggested that it is important for WHO as a science-based organization to adopt a more neutral tone on new technologies. He indicated that there is a clear need for prioritization of risks to avoid “crying wolf”. He noted that RF signals offer significant benefits using a technology for which there is relative scientific certainty that there are no significant risks to public health.
Dr. Rowley shared New Zealand’s application of precautionin the New Zealand resource management act “…Because the Resource Management Act is not a “no risk” statute, then the potential for risk is acceptable. That means the potential for adverse health effects will no longer be reason enough to decline a resource consent.’(Ministry of the Environment & Ministry of Health, 2000).
Plenary Comments The issue is whether technologies used by children are safe, we don’t have enoughinformation In terms of tone, the Framework includes examples of the benefits of technology It is important that parents understand the scientific perspective so they can make a determination of risk There are too few peer reviewed studies assessing the health effects associated with long term base station exposures to warrant scientific certainty. The general toxicological principle “the dose makes the poison”does not apply to nonionizing radiation. Public consultation is not necessarily a low cost option.
Dr. John Swanson of National Grid, UK’s electricity transmission company, presented an electricity industry perspective on the issue of power-frequency electric and magnetic fields (ELF EMFs). He noted that there is a spectrum of views and approaches and UK National Grid is at one end of the spectrum. For EMFs, he indicated that there is enough scientific evidence to justify considering precautionary action. To manage EMFs successfully requires facing up to the issue and balancing a number of factors such as science (strength of evidence), public health significance, public opinion, commercial factors and ethical responsibilities. Swanson argued that industry has a responsibility not just to shareholders but also to society to manage issues with a “proportionate”response. Some argue for options that involve spending large amounts of money which may be valid if the risk is high, however they carry a high “opportunity cost”. Money spent on reducing EMFs is money not available for other public health measures. There is a concern that increasing amounts of money will continue to be spent following initially reasonable decisions. Some of the reticence at embracing precautionary measures is accounted for by this fear of setting precedents which are then expanded.
Dr. Swanson noted that responsible companies that care about consequences to human health are successful companies. Public opposition is expensive in terms of money, staff and time. He noted the importance of a rational framework with sufficient status to be authoritative to guide “proportionate” responses as well as manage issues of liability. The WHO Framework appears well positioned to meet these objectives as it is based on accepted principles and is designed to reduce “disproportionate” responses. He cautioned that the real test of the Framework will be measured by the extent to which it is broadly accepted and applied.
27 Plenary Comments
We need clarification of terms in order to engage in dialogue with industry. I would tend to take the emphasis away from proportionality as some things cannot be quantified. If the word sounds too quantitative then we’ll find a different word, but I stick with it for now. How much is the right amount of precaution? We need a measure of the right amount of precaution. One aspect that should be addressed more carefully in ELFs is distribution of exposure and taking action to address the most exposed groups. This approach would move the debate forward. There is a failure to establish this kind of conversation with industry.
Dr. Deborah Moir, Chief, Radiation Surveillance and Health Assessment Division at the Radiation Protection Bureau of Health Canada presented a Health Canada framework for assessing and managing risk from radiological hazards. Health Canada’s radiation protection strategy contains elements of the Health Canada and the draft WHO Framework. The following principles underlie the strategy: i) risks and benefits of radiation are recognized early; ii) risk reduction strategies are developed in parallel with use; iii) risks and benefits are balanced; and iv) protection strategies evolve with new knowledge.
Dr. Moir provided an overview of risk assessment for ionizing radiation including identification of the short term and long term effects of radiation exposure. While the risks associated with exposure to high doses are well established there is considerable uncertainty of the risks at low levels of exposure as extrapolation from high dose effects is used as well as additional information from experiments on animals. Risk estimations made by various committees (UNSCEAR, ICRP, BEIR) are based on rigorous science and are in good agreement. The risk assessments use a linear no–threshold hypothesis which assumes that the risk is directly proportional to the exposure and all exposures carry some level of risk. Dr. Moir argued that this conservative assumption is a form of precautionary principle. The estimate of the probability of fatal radiation-induced cancers is based on extrapolations. There is a convergence of scientific opinion that the ICRP recommendations may overestimate fatal cancer risk.
Risk management strategies are based on a balancing of risks and benefits. Three basic principles guide risk management strategies: justification - where the goal is a net benefit to society; optimization –As Low As Reasonably Achievable (ALARA); Dose limitations –adoption of ICRP dose limits. Current limits ensure that no one is exposed to unacceptable radiation risks. Control is at the source for regulated practices (Nuclear Safety and Control Act; Radiation Emitting Devices Act). Nuclear facilities adhere to ALARA, ensuring that exposures are lower than the regulatory dose limits. Dr. Moir concluded that gaps in knowledge and uncertainties present a challenge in developing programs to protect workers, the public and the environment. There are uncertainties in risk estimates at doses less that 50 mSv. Therefore precautionary approaches are necessary in establishing risk protection strategies.
Plenary Comments Radiation protection and EMF are two completely different hazards with different sources and different mechanisms of effect. In EMF there is no dose dependent effect and we don’t know what the long term effects are. We always speak about cancer, but there are other endpoints, such as cell breakage.
Dr. Jorge Skvarca of PAHO/Argentina provided a perspective on standards, precautionary policies and health issues for EMF in Latin America. The development of standards and guidelines for EMF in Latin American countries is at various stages. National standards and guidelines are in place in Argentina,
28 Bolivia, Brazil, Columbia, and Chile based on the INIRC/IRPA guidelines (1998). The smaller countries (Panama, Paraguay and Uruguay) are just starting to adopt standards.
Dr. Skvarca noted that several common issues arise in risk management of EMF in Latin American countries. There is an absence of a rational and well established process for health policy and risk communication. In addition, several difference regulations and guidelines govern the same issue. As a result, local governments/municipalities, councils etc. do not always agree with National policies. Also, there is a lack of public trust in government and industry.
Local and regional inconsistencies in EMF standards in Argentina, Bolivia and Brazil reflect a lack of agreement with national standards and a misuse of the precautionary principle. Dr. Skvarca indicated that public concerns about the use of EMF, especially mobile phones are not based on science and are due to the intangible nature of EMF and deficient information provided by some opinion leaders. He noted the importance of national, regional and local authorities with the support of stakeholders and associations achieving agreement on the framework of the regulations and take responsibility for generating conditions to avoid unnecessary public concern. Latin American countries are looking to the international WHO/PAHO EMF project for advice and support on this issue.
Eva Marsalek of PMI (Plattform Mobilfunk- Initiativen), a non-profit association member of the Austrian environment umbrella association, discussed precautionary options for the siting of mobile phone antennas for mobile phone users. She posed the question: Is siting of mobile phone antennas of concern to the general public due to lower standards or other reasons? She referred to the WHO definition health “…A state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” and identified the following issues underlying the question of health effects:
The increasing contribution of mobile-communication to whole population RF-EMF exposures. The absence of a legal requirement for exposure monitoring and complete wireless freedom in siting of infrastructure. The absence of institutional collection of data on biological effects. International insurance companies explicitly exclude coverage of EMF health risks. The absence of neighbour involvement and rights in BTS (base transceiver station) siting.
Ms. Marsalek identified examples of options for minimizing long term exposure, through chronic exposure guidelines and intelligent siting and consultation processes to achieving public consensus. The Italian government has a chronic long term exposure limit of 6 V/m for areas where people are exposed for more than 4 hours in addition to several local agreements between providers, local politicians and citizens. This limit is based on the precautionary principle and the ALARA and ALATA principle. Measurement and monitoring in Italy and Styria-Austria have established that low exposure levels from BTS are technically and financially achievable. Ms. Marsalek suggested that something similar should be done by ICNIRP and recommended by WHO. Public consultation through roundtables in Salzburg, Austria (for 2 years), Venice, and Paris have demonstrated that consensus with citizens and increased acceptance of mobile phone infrastructure are possible. EMF exposure simulation software is available for intelligent siting and has been used in Salzburg Austria to estimate RF field exposure situations. In addition to determining planning options for exposure minimization the tool can facilitate communication between the public, providers and local authorities.
Ms. Marsalek identified the following precautionary options for mobile phone use:
Visible publication of SAR values on mobile phones Technical innovations to minimize exposures
29 A re-thinking of whether SAR is the right value Recommendation to use hands free kits Discourage use of mobile phone among children Restrictions on targeting advertisements towards children Studies to examine synergistic effects of other agents
Ms. Marsalek recommended a number of measures which are based on the precautionary principle and the WHO definition of health that should become international established procedure for installation of mobile communication infrastructure:
Exposure minimization by industry to as low as possible to guarantee quality service Public and local authority involvement in siting Information about existing and expected exposure values Exposure control through 24 hr monitoring Taking account of the local health situation Consideration of different siting options Open-minded discussion of different technical solutions (microcells, flat strips….) Publication of exposure data via internet Public and national database Collect citizen reports about wellbeing problems Solve the insurance problem
Ms. Marsalek concluded that these best practice measures are the basis from which to avoid public contests and social conflicts due to mobile communication infrastructure. In addition, these measures would enhance the reputation of the mobile communication industry and build trust in institutions (ICNIRP, WHO etc.), public officials and technology.
Plenary Comments
The agreement in Paris between operators and citizens groups encourages providers, local authorities and citizens to solve siting problems together. Public opposition is expensive. Should there be an international agreement between industry and citizens groups on how to roll out a network? Dialogue and transparency should be a matter of principle in planning network deployment. There are significant resource requirements on these sorts of exercises. Should WHO recommend that governments take the initiative to bring parties together to develop a charter on how to bring parties together? The principle is good but the structure in which the dialogue occurs needs to be given some thought. The issue of who should participate and vested interests of the parties. In the US, providers don’t care what citizens say, they just install antennas and base stations. I don’t know the right way but I second the idea of brining people together. I don’t know who should be in charge of the Charter. John’s (National Grid) approach is very encouraging. It is not WHO role to recommend to governments how they do policy. WHO can make recommendations and support governments in developing their own policies.
30 I believe the Ministry of Environment is responsible. There needs to be more attention to balancing risks and benefits and looking at the possibility that lower precautionary values based on uncertainty are not going to result in problems with safety devices (radars). Precautionary principle needs to look at what it is doing over the entire risk situation.
Jim Solyst, Senior Director for Science Policy at the American Chemistry Council, provided a perspective on the data and human resource demands related to implementing the precautionary principle at the state and local level. He noted that American Chemistry Council supports the RIO definition of the precautionary principle. He indicated that while the US does not have the precautionary principle enshrined in legislation there is no less commitment to the use of a precautionary approach. Queensland in Australia recently passed an ordinance on precautionary principle. The ordinance has practical implications for implementation as there are no toxicologists or epidemiologists on staff, and therefore there is a reliance on risk assessments done by other organizations such as USEPA, the National Toxicology Program and IARC. The States are dependent on IRIS data which contains toxicological information on a few hundred chemicals for the decision-making process. He noted that there it is a significant undertaking to update the databases with the most current information and it is not always clear to the user whether the databases include the most recent studies. Dr. Solyst recommended that the Framework emphasize practical implementation at the regional level, for example where should state and provincial authorities go for risk assessment information. He would like to see additional discussion on IARC and US databases such as National Toxicology Program and Integrated Risk Information System (IRIS) databases.
Dr. Kim Vicente, Professor of Mechanical & Industrial Engineering at the University of Toronto and founding director of its Cognitive Engineering Laboratory emphasized the need to go beyond the process aspects of the decision life cycle (which are covered well in the WHO framework) and incorporate an analysis of all layers of the system including organizational, political, social, and regulatory systems. These systems can be obstacles to the adoption of policies if they are not incorporated early in the decision-making process. The WHO framework promotes science on the risk as the primary criteria for decision-making. Dr. Vicente referred to the example of the lack of action on gun control in the US to illustrate that politics frequently trumps science in decision-making. He proposed that there is a science to organizational and societal change and how political change occurs and suggested that perhaps this broader science of social and political change can be incorporated into the Framework document.
Dr. Amir Attaran, Associate Professor in the Faculty of Law and Institute of Population Health at the University of Ottawa prefaced his comments on the Framework by expressing admiration for WHO on their technical work and their handling of SARS. The concept of a risk framework in supporting a technical need is good and can serve a useful role. If WHO addresses deficiencies in the current draft framework it can fill a need.
Dr. Attaran’s comments focused on the Framework’s insufficient recognition of developing countries and their needs and particularly the different complexion that risk-benefit tradeoff questions take in these countries in comparison to developed countries. He was critical of WHO’spast handling of difficult risk- benefit issues of special priority to developing countries, for example DDT for malaria control in Africa and GMO foods for famine relief in Zambia. Dr. Attaran offered the following suggestions to improve the Framework:
Be explicit in recognizing the difference between developing and developed countries
31 Make the connection between framework policy and operational guidance to WHO country representatives when they give advice. Questions such as how is the framework used and who is bound by it need to be answered. The Framework is currently written around EMF. The DDT-malaria control or GMO foods and food aid for countries during famine clearly offer starker risk benefits and more decision-relevant issues than EMF. Why not write the framework around these other areas where the risks and benefits are known. If the framework can function to resolve those issues then the document will be useful even in the EMF case.
Plenary Comments But this Framework is looking at precautionary measures where there is uncertain science, not prevention. Malaria science is not uncertain. EMF is currently a rich country problem that will rapidly become a problem for developing countries, so we’ve got to address that. I don’t think there is a dichotomy between prevention and precaution. With DDT and malaria the question is is DDT harmful to human health (it is carcinogenic, is it endocrine disrupting). The science in those areas is uncertain so you have to act on that science or not act on it on a precautionary basis. Same with GMOs. Are GMOs immunogenic in ways that are not good for us because they introduce non human antigens into the gut immune system? We don’t know.
Dr. Susie ElSaadany, Chief of the Statistics and Risk Assessment Section, Blood Safety Surveillance and Health Care Acquired Infections Division at the Public Health Agency of Canada provided a perspective on precautionary measures in blood safety. Because of the intensive amount of unavailable material required to estimate risk, the Statistics and Risk Assessment Section has frequently found a need to activate an international multi-channel network to yield expert opinion on various rare diseases and events in the areas of blood safety/blood borne pathogens (severe acute respiratory syndrome (SARS), West Nile Virus (WNV), Bovine Spongiform Encephalopathy (BSE/TSE, and vCJD) as well as health care acquired infections (surgical instrument sterilization breeches, risk of disease transmission from transplant material and hepatitis B Virus, Hepatitis C virus and HIV). Such networks must be broad and include diverse internal and external representation from i) regional/provincial/territorial/federal agencies; ii) international health agencies/departments/institutes; iii) international research groups/academia; and iv) international consulting and industry groups. Dr. ElSaadany discussed sample results from blood safety risk assessment studies conducted for BSE/vCJD and SARS and West Nile Virus. The key questions that must be considered in decision-making on precautionary measures for blood system safety is how much precaution is precaution and how much does it cost?
Dr. Robert Cushman, Medical Officer of Health for the City of Ottawa commented that the WHO Framework seems somewhat academic and interesting, but questions arise as to the extent to which it can be practically applied in public health settings. In developing Ottawa’s smoke free bylaw and the current issue of the cosmetic use of pesticides on local lawns there is no shortage of discussion on economics and the impacts of public health decisions on the marketplace. He noted that even in the first world we must be aware of consumerism and its power. Dr. Cushman proposed five parameters for the framework:
ii) Science: He noted that there are different interpretations of scientific findings and on the pesticide issue the epidemiological evidence is not sufficient to estimate the public health impacts of exposures. iii) Equity: There needs to create a level playing field and consider who you are protecting and who you are offending. With regard to the issue of second hand smoke individuals should be protected regardless of where they work or live.
32 iv) Rights: Questions of individual rights and rights of minorities vs. majorities arise. Individual rights need to be examined within the context of values. v) Economics: It is easier to keep products off the market than to remove them after market. In a market economy that is important and needs lots of consideration. There needs to be science on the economic issues. vi) Democracy: Elected officials reflect their public. Look at the innovation curve and where you are on the curve. Of 22 councilors one smokes. On the cosmetic use of pesticides the suburbs have power.
Dr. Cushman concluded that the Framework is a good document, but perhaps too theoretical and needs to incorporate perspectives from other sciences and disciplines and be brought down to a grassroots level where it will be used.
Plenary Comments One of the issues that we need to address is how do we get started…who is responsible. So that when a need is identified it is clear who has to drive the health risk assessment or implementation of the precautionary principle. We need to look at all layers of decision-making. It is easier said than done. The relationship between science and politics is difficult. There are 192 member states. You have to recognize the political climate. Advice has to be practical at the local level. Many developing countries are not going to look at the framework. They will come to WHO and say tell us what to do and how to do it. We should have a framework that will be useful at that level. At Health Canada we developed a framework at the same level of detail as the WHO framework document. It provided broad guidance on risk management. Over time a series of companion guidance documents were developed that provided more detail on specific issues. A similar approach could be undertaken by WHO addressing for example, economic methods for cost-benefit analysis, guidance for implementation at the grass roots level, etc. The meeting was planned to focus on EMF and test the framework with other issues. It might be good in short term to focus on EMF but as the framework evolves it may be useful to market it within WHO more broadly and make it general enough to manage issues mentioned by Amir. The problem that we had is that the constituencies of other areas of WHO were not consulted in advance in order to break formal existing approaches. We would need to involve food safety communities in the discussions. We can explore possibilities of going beyond EMF, but we have to involve a larger community. If we had a good tool in hand to look at risks, benefits and the social side when the DDT debate was starting we would have been in a better position to move forward. When we move into chemicals we will take into account the sources of information, IRIS databases, EU databases we need to look at the bigger picture. You can’t wait to make everyone happy when putting a policy framework together because it will never happen. At some point you have to decide this is not perfect, but it’senough and it will be useful for the people who were intended to use it. We should keep that in mind. The Krever Commission offers good lessons regarding process vs. layer of systems. I prefer to refer to “developed and developing” countries in Latin America rather than poor or rich countries because sometimes these are the consequences of bad government. Two points mentioned in the workshop: a risk-benefit analysis –you need to weight it and for this we will need or like to apply lessons on ionizing radiation. What we need from a Latin America perspective is practical advice. We are looking very carefully to international organizations for practical advice to answer
33 very simple questions –is living near power lines safe or not? Is using mobile telephone safe or not? These are simple questions and I understand that the answers are not easy to give. When we’re talking about the precautionary principle you need to clearly state what it means. In our country precautionary principle is used in different ways. In some countries they have prohibited base stations. Developing countries are looking very carefully to Canada and Europe for simple advice that will be practical. When we were working on developing risk communication analysis for mad cow disease in relation to blood safety WHO asked us to help Latin American countries. They found risk assessment to be a costly process and requires special training. We need to build a system in Latin American countries to understand and utilize risk assessment. WHO is going to establish an education program to have a standard approach to risk assessment internationally and develop a standard methodology. The McLaughlin Centre, which is now a WHO Collaborating Centre on Risk Assessment has an Ontario College of Graduate Studies certified training program in Population Health Risk Assessment. This consists of 5 courses which can be taken at the University of Ottawa and completed in a minimum of 8 months. The National Academy of Sciences recently released the BEIR VII report on the Biological Effects of Non-Ionizing Radiation in prepublication form. It updates the cancer risk estimates associated with low LET ionizing radiation. WHO is often asked tell us what we should do. There are several example of this in WHO Air Quality Guidelines for Europe, Drinking Water Quality objectives, EMF guidelines, WHO Radon Guidelines. There is a lot of work being done where difficult answers to simple questions are being offered in terms of guideline levels. These provide both the bottom line and also more detailed information on how to protect health. The debate is interesting. I believe the Framework should focus on EMF because I don’t believe that the prevention-precaution debate can be dealt with effectively in a writing exercise. I support the Framework being focused on EMF but be cognizant that it can be applied to other issues. I don’t think there is a problem with the process, it is more to do with commitment. Amir has described the huge amount of discrimination that takes place in decision-making. That’s not a problem of a framework it’sa problem in how the framework is implemented, how decisions are brought in, and how bureaucracies work decisions. So it’s a matter of commitment and Amir is right, there is a lack of commitment in some places. But a framework will not change that. We should work on the Framework as an EMF one now and recognize that it should be much broader. The Medical Officer of Health Robert Cushman said that we’retoo academic and we need to be more practical. Kim said that we have to work with different layers of systems. I can’t agree with them more and would like to recommend that you put some of the options either into the Framework or as a separate but linking document. There is so much information out there and I recognize that WHO has much of this information on their website but I think it’simportant to link it. Some of those who will be asked to apply the precautionary principle will be very knowledgeable and many others will not be knowledgeable. You need to make it as easy as possible to answer two questions: What do we do? And who does what? You have to identify the different levels of government, hydro, the cell phone industry, schools, occupations, and the home –what individuals can do. If you start identifying at those levels and listing the options, some will select some options and not others means that they are still applying the precautionary principle. An important aspect of the applying the precautionary principle is that it has to be cost-effective and at low cost because we are uncertain about the science. One of the first statements in the precautionary principle is to do nothing. That is an important statement to make and you should always have the option to do nothing. If you do nothing you are not applying the precautionary principle. A report recently came out in January by the Federal/Provincial/Territorial Task Force on EMF said that they applied the precautionary
34 principle and decided to do nothing and monitor the science being conducted elsewhere. This goes against the Rio conference definition which states that we must act in the absence of complete scientific certainty. I recommend that you take the “do nothing”option and put it prior to the precautionary principle so that if you decide to do nothing it is a decision to not to apply the precautionary principle and that is a legitimate decision. Doing something when you have no information is playing a political move rather than a scientific move for the purpose of addressing public perception We have seen that in BSE. Many of the decisions were politically driven. To move from doing nothing to doing something under the precautionary principle can be a very dangerous game. Since the framework is going to focus on EMF I recommend that uncertainties that go across the entire spectrum be identified. EMF is a wide spectrum of different agents from ELF to RF to pulse. Each of these agents is like comparing vegetables and fruits they are so different. One of the problems we have on risk communication on EMF in general is identifying what each of these areas are. People tend to focus on ELF and extend it to RF. We need to identify certainties and uncertainties across the entire spectrum. There are some areas in the spectrum where we have lots of data and we are certain about what the effects are. There are other areas in the spectrum that we have some uncertainties about and therefore need to emphasize more precautionary principle practices. The case studies were excellent and very enlightening. Canada has a recent history of some major policy disasters related to weaknesses in our addressing science policy issues. The big one that was missing was the collapse of the cod fishery which is now regarded globally as the single greatest failure of the use of science in managing a resource. The question was not science or uncertainty it was the science-policy interface. For a Framework to be effective there needs to be something that very explicitly addresses what is that intersection between science and policy. Having an explicit faith in science clearly has not worked in Canada (tainted blood, BSE, cod fishery, forests). It hasn’t been due to a lack of science, uncertainty has been an excuse for not acting. In my view the Framework weaknesses are as follows: There is reference to Figure 1 as the Framework. In that case, the Framework is the US. Presidential Congressional Framework. If that is the Framework then what we are talking about is a risk management framework. The idea of having precaution as an overarching issue somewhat minimizes the role of precaution in the Framework. Largely it is a traditional risk management framework that the Americans use and we largely use with some reference to precaution. Regarding the way precaution is characterized in the document –in the paragraph that describes the precautionary principle there are six adjectives: negative, reduce, erode, undermine, misguided and damage. This gives an unusually negative perspective on precaution. Typically if you read the precautionary literature it is largely about increasing transparency, improving public trust not eroding public trust and decreasing transparency which is how it is being characterized in the document. If the document is to move the debate forward around how we understand and use precaution in risk frameworks there needs to be a more balanced approach to the description of precaution in the document. An inconsistency is the desire to have legal certainty and predictability is stated in the document yet the recommendations are around voluntary measures. One of the weaknesses of voluntary measures reported in the literature is they have little legal certainty and little predictability. Also with voluntary measures in the final page in the EMF case study there is significant reference to low cost (used 5 times) which I think is an unnecessary overemphasis on cost in this particular case. Low cost and cost-effectiveness are very different things. Typically voluntary measures are low cost but they are very frequency not cost-effective because they have little effectiveness. Low cost and cost- effectiveness related to precautionary could be highlighted. Maybe because in Canada we have seen
35 the Privy Council Office document and there has been a lot of debate around precaution perhaps compared to some other countries we have a more active debate around it. From my perspective there is the possibility that this will be a helpful document for the countries that have less active debates but for Canada I don’t feel that it is contributing particularly much to how we understand and use uncertainty and precaution. The cod fishery issue is a good example to illustrate that the science was there, the risks were understood but there was a lack of transparency about the decisions that were being made and a lack of public debate on science. You need the public dialogue in order that the science is heeded in a public policy sense. It’san interesting point that voluntary measures might not have legal certainty or predictability. The predictability and the certainty comes in clarifying the options. You could have a voluntary or mandatory standard, mandatory certainly has legal predictability. If voluntary measures are issued and the case is found that by not applying those voluntary measures the industry is at fault and may cause injury those voluntary measures still become legal when it goes to court. Those measures were not followed as good practice. While there is a fine line, voluntary measures can still have legal predictability and certainty. That is very important to this framework. Whether a measure is voluntary or mandatory has nothing to do with the legal enforceability. What makes something legally enforceable is the way you codify it. Is it a regulation, a statute or a guideline? Statutes and regulations are law, guidelines are nice words. You could always agree in a voluntary sense what goes into a regulation. Or you could mandate a regulation, both are equally binding. Or you could mandate a guideline or voluntarily agree on a guideline, both are non- binding. There is a continual debate over how precautionary the risk assessments are. The debate goes on in the risk assessment process even though the word precautionary principle is not used. I would not want the framework to draw that distinction that somehow precautionary principle stands alone. In fact we’re talking about scientific uncertainty, public health and about conservative values. If you have a voluntary guideline on a particular issue and because someone didn’t follow it and caused injury as a result wouldn’t that be just as binding in a court as a regulation? 3 No, for example in BC there is an air quality guideline not to exceed 50 ug/m 24hr avg. PM10. Several times a month levels exceeded 600 ug/m3 however we did not win the case on the basis of exceeding the guideline. There is no way to turn a guideline into something that is binding. In EMF there are safety guidelines that take into account the scientific uncertainty and recommend standards based on that. When you’re promoting precaution because of scientific uncertainty are you saying that those built in precautions are inadequate and we should be looking at revising them? Whether you are talking of a non-binding guideline or a statue or regulation that is binding in a legal sense there is a role for precaution to be in either one or not. These are societal choices that are totally different from the legal considerations of what instrument you use. Without a specific context are we talking PM10 or EMF or chemicals, which chemicals, which exposures, which health risks, there isn’t a straightforward answer. If the WHO is attempting to develop a framework that will apply to precaution then it should work in a number of areas and should be tested and not just in the context of a workshop, but have a number of case studies that cover a wide variety of fields. When you come to providing guidance to member states, the member states are looking for the WHO to provide answers, they need to be able to see the differences in approach, the different considerations and factors that go into how the framework is applied with regard to any particular agent or chemical. The best way for the document to become a much more authoritative document is that it is set up as a broad framework supplemented by a
36 number of case studies covering different areas in different fields. The current Framework is rather theoretical which is fine if you’re complementing that with case studies. The case studies need to be more detailed, illustrate more practical thought processes and discussions and considerations that take place to arrive at recommendations. There are potential trade implications of applying the precautionary principle. For instance, the REACH regulation in Europe is quite broad and is essentially the embodiment of the precautionary principle towards chemicals. US chemical regulations are different. It might be worthwhile to put something in the framework on that issue if there is not already. I would support that suggestion. There is a fine line between precautionary actions and the result being trade restrictions. It is certainty worth addressing in the framework.
Dr. Daniel Krewski, Professor and Director of the R. Samuel McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa presented a summary of the WHO Framework strengths, shortcomings, and recommendations for improvement that were proposed by speakers in the first two days (July 11-12) of the workshop. The presentation summarized the strengths of the Framework as follows:
It aims to avoid misuse of the precautionary principle and disparities between national policies It provides a basis for identifying cost-effective investments to reduce potentially harmful exposures in the face of scientific uncertainty It aims to identify the level of precaution required to protect public health It is based on accepted principles and designed to reduce disproportionate responses It provides a basis for identifying what we know and what we know we don’t know WHO definition of health provides incentive to think beyond morbidity and mortality (including known and unknown risks, risk perception, social well-being) It aims to promote open and transparent decision-making through ongoing communication and consultation with stakeholders It promotes identification of win-win solutions from the outset It encourages implementation of a wider range of risk management options It promotes examination of risk tradeoffs –what are the risks and benefits of alternatives It promotes explicit consideration of ethical values, social and cultural factors, public concerns/risk perceptions It guides identification of research priorities to address gaps in knowledge It correctly focuses on the process of decision-making rather than on substance of what would be considered precaution in a given scientific context Explicit value statements: “priority is given to preventing risks, wherever possible, not just controlling them” make it easier to interpret and apply precaution in a given context It provides a basis for triggering decision points (i.e. declaration of pandemic flu) Important aspects of Canada’s Privy Council Office framework are incorporated (transparency, accountability, public involvement, actions proportional to severity of risks, non-discriminatory and consistent, cost-effective) It is a significant improvement from the October 2004 draft. There is a greater emphasis on the scientific basis for actions, greater consistency in usage of terminology.
The following areas in which to strengthen the document were identified:
The lack of clarity in terminology: scientific uncertainty, precaution, and precautionary principle. There are not universally accepted definitions for these terms and they are prone to widely varying interpretations.
37 The need to provide more concrete and practical guidance. The challenge is to strike a balance between precision and flexibility. Mechanisms for strengthening stakeholder involvement throughout the process need to be articulated, considering differences between cultures and societies. The Framework describes a process or sequence of stages for decision-making, but is missing an analysis of the structure and dynamics of the system at multiple levels (i.e. work, staff, management, corporate, regulatory, government). There is little guidance provided on how to prioritize risks so decisions can be made on how allocation of resources.
The following recommendations were provided for future improvements to Framework document:
Provide definitions and consistent use of terminology: uncertainty, precaution, precautionary principle, risk analysis. Provide more formal integration of assessment of risk perceptions and psychosocial impacts as part of the scientific risk assessment and risk management process. Include suggestions to guide how effective and legitimate precautionary actions are to be developed. Consider whether consultation and participation at the various steps should be mandatory. Consider mechanisms for reviewing and assessing transparency and accountability. Frameworks should help identify who is responsible for ensuring that comprehensive and timely risk assessments are undertaken (lessons from BSE and Walkerton). Application of the Framework should lead to a reduction in the risk of damage due to EMF exposure (especially to children) for acceptance by ENGOs and health-based NGOs. Framework should require explicit characterization of the impact of alternative risk assessment assumptions that are applied in manipulation uncertain information. Framework document should discuss science vs. values more thoroughly. Framework document should discuss benefits at a higher level than strictly the application of benefit- cost analysis and cost-effective analysis. Framework document should adopt a more neutral tone on new technologies, they are not always dangerous.
Plenary Comments:
Need to add “specific”. This was referred to several times by Heather McLeod-Kilmurray. If you go to court you have to have specific scientific details, specific uncertainties etc. We have to be accurate about the scientific uncertainties. Also we need to be sure that in what we develop we don’t undermine the standards. We might do some preliminary risk assessment studies because we were caught off guard by the word precaution. The latest report from UK scientists is the use of the word precaution seems to elicit fear and certainty that there is a hazard. We need to be savvy and say what we mean to say and do what we mean to do. The only way we can do that is to do some analysis. I see an opportunity in the development of this framework to include a gender-based analysis at all levels of the risk analysis process. That would be at the risk profile preparation stage, the actual risk assessment, risk management stages, the opportunity for targeted interventions that impact men and boys, women and girls also at the monitoring and action evaluation stage. I would like to suggest consideration in the preamble of the framework not unlike the type of preamble we see in the international tobacco control convention, which was the first international convention to recognize women and men in the preamble.
38 Would you be sympathetic to having the preamble mention other potentially susceptible subgroups such as children? Yes disadvantaged groups would be an excellent suggestion and would be in keeping with the spirit of equity. So gender based and special subpopulations could both be addressed. We’ll have to be very careful about the drafting of the wording and we may want to consult some groups with respect to what is appropriate language. The discussion from Kim Vicente and looking at the different layers of structure is important to build into the framework. That leads to the issue of the science-policy interface. That is currently not in the framework. It should be and provides more depth. We’ll go back to Kim to see how we can incorporate it.
Michael Ripacholi posed the following issue for discussion. Precautionary measures shouldn’t undermine the science. We have science-based guidelines. A number of countries can alter the guidelines in the name of their own science or in the name of precaution. WHO as a general policy will recommend international standards or guidelines where they exist and are based on good health risk assessments and sound science. A number of other governments can develop their own standards. They say they have information that they feel that the standards need to be lower than the international guidelines suggest. WHO says if you want to change the guidelines you need to provide a rationale. If the information is so compelling that exposure limits should be revised then we want access to the information to share with the rest of the world as they may impact the international guidelines. If you are just in an arbitrary way reducing international guidelines our feeling is that it can be undermining the science and as such the hundreds of millions of dollars of research gone into the health risk assessments and standards development are wasted.
Plenary Comments: In Italy for example the application of the precautionary principle is documented, but the essential word is minimization. In Austria minimization is the key word, to leave space for new applications, and new EMF technologies. I have the fear that focusing so much on the scientific base poses a big risk that the politicians that have to apply the document in everyday political life and due to the complexity of the EMF issue (ELF, RF and radar) there is no real guidance in how to apply the framework in everyday political decision-making. There is the risk that the option that is offered in the first sentence more or less, to do nothing will be taken as a precautionary principle action. The problem is to recommend voluntary measures as good practice, they should be listed. For base stations there is no personal choice to reduce exposures. You have an appendix for ELF, I would appreciate an Appendix for base stations and for mobile phones because they require different approaches. Your question bears on a number of issues that have been raised i.e. the values. Although in the preamble the document recognizes the role of ethics, it’snot made explicit. One possibility to reconcile related issues such as risk perception and benefits would be to include explicitly risk acceptability evaluation within the framework within risk evaluation. It gives an explicit choice to opt out of some of those standards based on the justification of values. The most powerful science that challenges the current global guidelines for EMF which is roughly 1000 mG exposure for any 24 hr period comes not from childhood leukemia but from breast cancer studies. We have in vivo laboratory studies where mice are exposed to magnetic fields, mice whose breast cancer has already been induced and we find the magnetic field promotes the growth of the tumour, reduces latency, and increases the size of the tumour. This is shown for values between 1
39 and 250-500 mG. We have laboratory studies working with human breast cancer cells that have been isolated from women showing that a magnetic field above 12 mG promotes the growth of these cancers and reduces the effect of tamoxophen. We have epidemiological studies with both men and women showing an increase risk when they are exposed to magnetic fields. For men the risk is often about 3-4 fold, for women the risk varies between 20 fold increase to several fold increases depending on whether or not they are looking at breast cancer in general, with many causes, or whether they are looking at estrogen positive breast cancer cells. In Canada, 1 in 10 women will develop breast cancer. This is very powerful evidence to suggest that we have to reduce the limit from 1000 mG to something that protects women and children. The breast cancer link with exposure to low frequency magnetic field is not established yet, there is some evidence for and a lot of evident against. WHO will be going through a formal task group review of all of the evidence of the low frequency fields in October of this year and will be coming out with final conclusions at the end of this year. Those questions will be addressed in very rigorous scientific detail. I was thinking that this meeting would be broader than EMF. What needs to be included in the framework are two issues: global warming – which is really uncertain, we don’t have enough evidence but we have a lot of evidence that global warming is coming with all the possible effects on environment and on mankind. The other issue is energy production, related or unrelated to global warming using fossil fuels but also nuclear power stations. This goes back to ionizing radiation and the related discussions regarding whether it is potentially harmful and potentially hazardous and to what extent are the risks outweighing the costs related to energy from fossil fuels. The principle ALATA (as low as technologically achievable) may transfer us as scientists to hostages of the industry who will say your science is ok but it is not technologically achievable. This should be carefully addressed in any document which may or may not be addressed in the framework documentation. The opening lecture referred to the WHO definition of health. I agree with the definition but if this is so, the words health effects and health issues in the document are not realistic. It is concerned with the health hazard not the health issues. Health issues include both hazard and benefit. There are millions of people who benefit from medical application of EMF. My suggestion is to speak for either health hazard or carefully define what we mean by this term. We have with the EMF Framework the issue of terminal vs. nonterminal effects. I strongly disagree with placing non- terminal effect as nonexistent and unconfirmed. We are fighting two different approaches: nonterminal approach – I don’t agree with all the experience we have is that this is not realistic. At the same time nonterminal effects of the same RF are not considered. This needs to be addressed in the document. I already spoke about the need in the document for some items or chapter which says that to resolve the uncertainty for EMF we need to plan, execute and discuss multi-centre studies in potentially different countries with the same equipment and subjects and then speak about uncertainty. I agree that replication studies are not publishable and that’s why I am proposing this. The use of consensus in this document is not reasonable because it is very hard to achieve consensus and the consensus is among a specific circle of people. Others outside the circle may not agree, so the consensus is not applicable in general. I would like to congratulate WHO on organizing such an important meeting. It is important to have general principles, but as we have seen during this meeting it will be difficult to have a more detailed general framework. It would be important to have more detailed case studies especially in my domain of EMF it would be important to have more examples. As you suggested previously, it would be important to have more details on the precautionary practices of different countries. This would be possibly done in the following month, but also undertake monitoring of the procedures that have been implemented by different countries. This would be more useful than having every country or province or government to have to conduct its own review of the practices of different countries. WHO could monitor the various practices in sufficient detail.
40 To avoid confusion, I agree that if this is a guidance document for regulatory authorities in the context of a national or regional standard you can actually apply all of these issues of societal factors etc. When WHO provides health based guidelines we cannot look at the social, political factors across the world generally. So we provide health based guidelines and then countries are free to set standards that exceed or go below them if they can afford it. They have to explain why, but it is not undermining the science if we apply those other factors. We can only do it at the international level if we have the legal basis for that. This legal basis would be if there are trade implications like in the case of food commodities and we can go to the Codex and they have international standards that are agreed on by member states. Or if we have a treaty like the Stockholm Convention on POPs etc. then one could agree on a ban. While it might be an interesting suggestion to look at regulations across the world and try to harmonize them it will still be a voluntary approach unless we have a legal instrument in place and those who have been involved in the development of legal instruments internationally know that it is a lengthy process that is very costly and whether it’s worth it is arguable. There are developments that will assist us in harmonizing without legal instruments in the chemical arena, for example with the strategic approach to international chemicals management.
41 5.0 Direction for Improvements to the Draft Framework Document
This section provides a summary of the directions for improvements to the draft Framework proposed by the workshop speakers and delegates. The comments are organized according to themes and are not in any order of priority.
Terminology Issues
While it was recognized that the current document has improved from previous drafts in its consistent use of terminology, the following terms were identified as requiring clarification as they are prone to wide variation in interpretations: scientific uncertainty, variability, precaution, precautionary principle, risk analysis, health and health hazard, and proportionality.
Specificity/Operational Guidance
The need to provide as much specificity as possible (specific risks, uncertainties, underlying values, assumptions, burden of proof, standard of proof) was recognized both to enhance the document’s practicality and to minimize opportunities for legal challenges of precautionary measures. The challenge is to strike a balance between precision and flexibility. For example, it was suggested that the Framework should help identify who is responsible for ensuring that comprehensive and timely risk assessments are undertaken. In addition, it was suggested that guidance be provided in the Framework to point those who do not have risk assessment expertise to existing sources of toxicological and risk assessment data (i.e. IRIS, NTP etc.). The need for more specific guidance was also recommended to address how to develop effective and legitimate actions including expertise, rules of participation, duties to consult etc. Questions such as how is the Framework used and who is bound by it need to be addressed. It was suggested that the Framework document could benefits from incorporating perspectives from other sciences and disciplines and brought down to a grassroots level. The availability of excellent resource documents by WHO is related areas was recognized and it was suggested that linkages be made between the Framework document and these complementary supporting references.
Framework Clarification
It was suggested that the Framework appears to be essentially the US Presidential Congressional Framework for Risk Assessment and Management and as such is really a framework for risk management. It was suggested that the idea of having precaution as an overarching issue somewhat minimizes the role of precaution in the Framework. The relationship between the existing US framework and the WHO Framework proposed in the draft document needs to be clarified.
Document Tone
Section 2.4 was noted to contribute to a negative characterization of precaution in its use of terms such as negative, reduce, erode, undermine, misguided and damage. It was suggested that precaution is typically characterized in a positive way and the Framework should establish a more balanced approach to its description. It was also suggested that the document overemphasizes the negative aspects of new technologies.
Stakeholder Involvement
While the document was noted to be strong in its emphasis on stakeholder involvement at all phases of the Framework it was suggested that guidance on mechanisms for stakeholder engagement be provided. It
42 was also suggested that consideration be given to i) whether consultation and participation at the various steps should be mandatory as well as ii) mechanisms for reviewing and assessing transparency and accountability.
Option of No Action
It was suggested that the option to take no action is essentially a decision to not use the precautionary principle and as such should not be identified in the list of example precautionary options.
Decision-making Systems/Structures
The role of organizations and social systems at all levels was deemed critical to the decision-making process as well as to the effective implementation of policy options. The Framework describes a process or sequence of stages for decision-making, but is missing an analysis of the structure and dynamics of the system at multiple levels (i.e. work, staff, management, corporate, regulatory, government). It was suggested that this be recognized in the document and illustrated in the EMF case study by identifying the various organizations involved in the decision-making process at the local, regional, national and international levels.
Risk Prioritization
It was suggested that more information be provided on tools and approaches for risk prioritization.
Integration of Risk Perception
It was suggested that the assessment of values and perceptions of hazard and risks be explicitly recognized within all phases of Framework.
Criteria for Evaluation
It was noted that application of the Framework should lead to a reduction in the risk of damage due to EMF exposure (especially to children) for acceptance by ENGOs and health-based NGOs.
Benefits
It was recommended that a higher level discussion of benefits beyond a discussion of tools for economic and health benefits analysis be incorporated in the document.
Science vs Values
While the document was noted to be strong in its articulation of core values underlying precaution and the need to consider values in assessing options, it was suggested that there be an expanded discussion on science vs. values.
Uncertainty
It was suggested the Framework should promote more explicit characterization of the impact of alternative risk assessment assumptions that are applied in handling uncertain information.
43 Trade Implications
The trade implications of applying precautionary principle should be more fully discussed in the document.
Needs of Developing Countries
It was noted that the document does not explicitly address the unique issues and needs of developing countries, and lacks a discussion of the differences between assessment of benefits of precautionary actions in developed and developing countries.
Vulnerable Populations
It was suggested that the need for gender-based risk analyses as well as consideration for potentially susceptible subgroups including as children and other vulnerable subpopulations be emphasized in the document Preamble.
Science-Policy Interface
It was suggested that the practicality of the document would be enhanced through a discussion of the interface between scientific risk assessment and policy implementation.
Case Studies
There were a variety of viewpoints expressed on the use of case studies in the Framework document. One view was that the EMF case study should be the only case study in the document as additional case studies are unlikely to resolve debates around decisions made on more certain risks in the context of developing countries. The document could be followed by more specific guidance documents that would address specific aspects of the Framework process. Others indicated that the document should include several case studies on a variety of risk issues that have various degrees of uncertainty. A number of suggestions were provided including issues of particular relevance to developing countries (DDT for malaria control, GMO foods for food security), as well as global warming, and energy alternatives.
Weight of Evidence
It was suggested that criteria for weighting qualitative and quantitative data be provided in the Framework document.
EMF Case Study
An inconsistency was noted in the document’s stated desire for legal certainty and predictability, yet the recommendations are around voluntary measures which have little legal certainty and little predictability. There was also an overemphasis on “low cost” measures in this particular case. The distinction between low cost and cost-effectiveness related to precautionary measures could be highlighted. It was suggested that the document recognize the need for multi-centre studies using common methodologies in order for a sound weight of evidence approach. Also the need to clarify risks and uncertainties across the spectrum of EMF was suggested. The need for a discussion on the distribution of exposure was also recognized. It was suggested that the case study include an Appendix for base stations and mobile phones as they require different approaches for exposure reduction. It was suggested that WHO provide more details on the
44 precautionary practices of various countries and undertake monitoring of the effectiveness of various precautionary approaches.
45 APPENDIX A –LIST OF PARTICIPANTS
1 Carol Amaratunga Catherine Allison Women’s Health Research University Public Health Agency of Canada Institute of Population Health Room 210B, 130 Colonnade Road University of Ottawa Ottawa, Ontario Canada 1 Stewart Street K1A 0K9 Ottawa ON K1N 6N5 Canada 613-952-0903 613-562-5800, ext. 2646 [email protected] [email protected]
Peter K. Ben Embarek Tammy Bell Scientist Public Health Agency of Canada Department of Food Safety 100 Colonnade Rd Zoonoses and Foodborne Diseases, A.L. 6201D, Rm033A World Health Organization (WHO) Ottawa, Ontario Canada 20, Avenue Appia 613-948-9257 CH-1211 Geneva 27, Switzerland [email protected] 41 22 791 42 04 [email protected]
Dave Bennett Connie Berry Canadian Labour Congress Graduate Student 2841 Riverside Drive Certificate Program in Population Helth Risk Ottawa ON Assessment and Management K1V 8X7 Canada University of Ottawa 613-526-7418 1 Stewart Street [email protected] Ottawa, Ontario K1N 6N5 Canada [email protected]
Aderbal Bonturi Pereira Andrew Bichan Latin-America Director Hutt Valley District Health Board Mobile Manufacturers Forum Private Bag 31 907 Av. Paulista, 2300 - Andar Pilotis Lower Hutt, New Zealand CEP 01310-300 64-4-570-9075 Sao Paulo, Brasil [email protected] 55-11-6847-4610 [email protected]
2 Jean Claude Bouillet Milt Bowling Directeur Fréquences et Protection Clean Energy Foundation Bouygues Telecom 3570 Corsica Way 20 Quai Du Point du Jour Vancouver, BC Canada 92100 Boulogne V5S 4J3 33-1-3926-6144 604-436-2152 [email protected] [email protected]
Kevin Brand Assistant Professor, School of Management Jean-Claude Brien McLaughlin Centre for Population Health Risk Industry Canada Assessment, University of Ottawa 365 Laurier Ave. W 1 Stewart Street Ottawa ON Canada Ottawa ON K1N 6N5 Canada 613-990-4698 613-562-5257 [email protected] [email protected]
Sarah Bullock Radiation and Environmental Health David Butler-Jones World Health Organization Chief Public Health Officer 20 Avenue Appia qq Public Health Agency of Canada CH-1211 Geneva 27 130 Colonnade Road Switzerland Ottawa, Ontario Canada 41 22 791 40 76 Phone: 613-954-8529 [email protected]
Kazuhiko Chikamoto Eunice Chao Japan NUS Co., Ltd. (JANUS) PhD Candidate Population Health Loop-X Bldg 7F, 3-9-15 Kaigan University of Ottawa Minato-ku 1 Stewart Street Tokyo, Japan Ottawa ON K1N 6N5 Canada 81-3-5440-1865 613-562-5800, ext. 2367 [email protected] [email protected]
3 Robert Clarke Jin-Ho Choi Executive Director Daejeon Yusung-Gu 103-16 Munji-Dong McLaughlin Centre for Population Health Risk Korea Electric Power Research Institute Assessment, University of Ottawa Korea 1 Stewart Street 82-42-865-5051 Ottawa ON K1N 6N5 Canada [email protected] 613-562-5280 [email protected]
Jack Cornett Robert Connell Director, Radiation Protection Bureau Diamant Building Blvd. A. Reyers 80 Mobile Manufacturers Forum Brussels, Belgium 32-2706-8567 [email protected]
Abiy B. Desta Lorraine Craig U.S. Food and Drug Administration University of Waterloo 9200 Coporate Blvd. (HFZ-120) 519-579-6022 Rockville, MD email: [email protected] 301-796-0293 [email protected]
Paul Dick Mike Dolan Elanco Animal Health Mobile Operators Association 150 Research Lane, Suite 120 2nd Floor, Russell Square House Guelph ON Canada 10-12 Russell Square 1-800-265-5475 London, UK [email protected] 44-20-7331-2014 [email protected]
4 Bersabel Ephrem Susie ElSaadany IDPC-DGO Chief, Statistics and Risk Assessment Section Blood Public Health Agency of Canada Safety Surveillance and Health Care Acquired 100 Colonnade Rd Public Health Agency of Canada A.L. 6201D, Room 034A A.L. 0601E2, Building No. 6, Tunney 's Pasture Ottawa, Ontario Canada Ottawa, ON K1A 0L2 613-948-3557 613-952-6925 [email protected] [email protected]
Dennis L. Erpelding Lyle S. Fairbairn Manager Fairbairn Regulatory Consulting Elanco Government Relations, Public Affairs and PO Box 529, Stn "B" Communications Ottawa, Ontario Elanco Animal Health K1P 5P6 2001 West Main Street, P.O. Box 708 613-236-9212 Greenfield, IN 46140 [email protected] 317-276-2721 [email protected]
Claire Franklin Barry Fraser Research Fellow Fraser Consulting and Associates McLaughlin Centre for Population Health Risk R.R. #3 Assessment, University of Ottawa Chatham, Ontario Canada 1 Stewart Street N7M 5J3 Ottawa, Ontario 519-351-0328 K1N 6N5 [email protected] 613-562-5800, ext. 2360 [email protected]
Sue Fusco Greg Gadja Director and Founder Health Canada Stop Transmission Lines Over People 775 Brookfield Road 6 Allen Manor Ottawa, ON Markham, Ontario 613-954-0309 L6C 1B2 [email protected] 905-887-2173 [email protected]
5 Denis Gauvin Marie-Christine Gervais Institut national de santé publique du Québec Institut national de santé publique du Québec 945, avenue Wolfe 945, avenue Wolfe Sainte-Foy, Québec Sainte-Foy, Québec G1V 5B3 Canada G1V 5B3 Canada 418-650-5115, ext. 5221 418-650-5115, ext. 5221 [email protected] [email protected]
Roger Glass Sally Gilbert Hydro One Networks Ministry of Health 483 Bay Street, 14th Floor P.O. Box 5013 Toronto ON Canada Wellington, New Zealand 416-345-5107 64-4-495-4345 [email protected] [email protected]
Wayne Gorman Daniel Goulet Health Canada Hydro Quebec CANADA 775 Brookfield Road 800 Maisonneuve est 21e etage Ottawa ON Montreal Quebec CANADA Canada Canada 613-946-6827 514-840-3000 [email protected] [email protected]
Paul R. Gully Geoff Granville Deputy Chief Public Health Officer Manager, Toxicology & Material Safety Public Health Agency of Canada Shell Canada Limited 130 Colonnade Road, A.L. 6501C 400 - 4th Avenue S.W. Ottawa, Ontario K1A 0K9 Calgary, AL T2P 2H5 CANADA Canada Phone: 613-954-9663 403-691-2220 [email protected] [email protected]
6 Choong-Kyo Han Marta Haley Seoul National University Elanco Animal Health School of Electrical Engineering, Seoul National 150 Research Lane, Suite 120 Seoul Gwanak-gu University, San 56-1 Sillim-dang Guelph ON Korea Canada 82-2-880-7258 1-800-265-5475 [email protected] [email protected]
Magda Havas Gary Holisko Trent University BC Hydro Environmental & Recourse Studies 5-6911 Southpoint Drive Peterborough, Ontario CANADA Burnaby BC CANADA K9J 1B8 V3N 4X8 705-748-1011, ext. 1232 604-528-1770 [email protected] [email protected]
Takaharu Iwamura Sheila Johnston Nomura Research Institute, Ltd. Neuroscience Consultant 1-6-5 Maramouchi, Chiyodaku Telecommunications and Health Tokyo 100-0005 10 Queens Mews Tokyo, Japan London, UK 81-3-5533-2877 44-207-243-3860 [email protected] [email protected]
Ghinwa Karouni Industry Canada Nataliya Karyakina 365 Laurier Ave. W Project Assistant Jean Edmonds South Tower, 2nd Floor McLaughlin Centre for Population Health Risk Ottawa ON Assessment, University of Ottawa Canada 1 Stewart Street 613-949-5669 Ottawa ON K1N 6N5 Canada [email protected] 613-562-5800, ext. 2358 [email protected]
7 Ray Kemp Deok Won Kim Head, Risk Management Group Department of Medical Eng. Galson Sciences Ltd. Yonsei University Medical Center 5 Grosvenor House Seoul CPO Box 8044 Melton Road Korea Oakham LE156AX 82-2-2228-1916 00-44-1572-770649 [email protected] [email protected]
Jaejoon Kim Transmission Construction Dept. Eung-Sik Kim KEPCO 167, Samseong- Dong Hoseo University, Korea Korea Electric Power Corporation (KEPCO) 29-1 Sechul-ri Baebang-myun Asan Gangham-Gu, Seoul, 135-791 Chungnam, Korea Seoul, Republic of Korea 82-41-549-2284 Korea [email protected] 82-2-3456-5112 [email protected]
Yoon-Shin Kim Hanyang University 17 Haengdang-Dong Lars Kindervater Sungdong-Ku T-Mobile International Seoul, Korea Landgrabenlieg 151 133-792 Bonn, Germany 82-2-2220-0692 49-228-936-15224 [email protected] [email protected]
B. Jon Klauenberg Daniel Krewski Human Effectiveness Directorate Scientific Director Directed Energy Bioeffects Division McLaughlin Centre for Population Health Risk Air Force Reseach Laboratory Assessment, University of Ottawa Radiofrequency Radiation Branch 1 Stewart Street 8262 Hawks Road, Building 1162 Ottawa ON K1N 6N5 Canada Brooks City Base, TX 78235-5147 USA 613-562-5381 210-536-4837 [email protected] [email protected]
8 Niels Kuster Tyler Lacombe Professor ETH Zurich, ITET Department Industry Canada Swiss Federal Institute of Technology ETHZ 365 Laurier Ave. W IT'IS Foundation Ottawa ON K1A 0C8 Zeughuasstrasse 43, 8004 Zurich Canada Switzerland 613-990-4722 411-245-9696 [email protected] [email protected]
Julio Lagos Jacques Lambrozo Canadian Electricity Association Service des Etudes Medicales EDF-GDF 263 Roncesvalles Avenue 22-28 rue Joubert - 75009 Toronto Ontario CANADA Paris, France 416-535-2815, ext. 21 33-1-5531-4601 [email protected] [email protected]
Serge Lamothe Denise Laplante Ingenieur en electricite Graduate Student, Population Health Program Hydro Quebec University of Ottawa 75 boul. Rene-Levesque Ouest Dept. of Epidemiology and Community Medicine Montreal Quebec CANADA 451 Smyth Rd 514-289-2211 Ottawa, Ontario CANADA [email protected] K1H 8M5 613-562-5800, extension 8292 [email protected]
Dave Lecuyer Dong-Il Lee Health Canada Daejeon Yusung-Gu 103-16 Munji-Dong Room 238 Radiation Building Korea Electric Power Research Institute 775 Brookfield Rd Korea Ottawa ON K1A 1C1 Canada 82-42-865-5850 613-829-8902 [email protected] [email protected]
9 Yu-Chen Lei William Leiss National Taiwan University Scientist College of Public Health McLaughlin Centre for Population Health Risk Centre for Health Risk Assessment and Policy Assessment 1 Ren-Ai Rd., Sec 1 University of Ottawa Taipei, Taiwan 1 Stewart Street 886-2-2351-7729 Ottawa, Ontario Canada [email protected] 613-297-4300 [email protected]
Louise Lemyre Eric Lemay Full Professor, Psychology, Social Sciences Health Canada McLaughlin Research Chair on psychosocial aspects of 775 Brookfield Road risk and health / GAP-Santé Research Team Ottawa, Ontario CANADA Institute of Population Health 613-941-3549 University of Ottawa 1 Stewart Street, Room 312 [email protected] Ottawa, ON, CANADA K1N 6N5 613-562-5800, extension 1196 [email protected]
Yi-Ping Lin National Taiwan University Patrick Levallois College of Public Health Institut national de santé publique du Québec Centre for Health Risk Assessment and Policy 945, avenue Wolfe, 4e etage 1 Ren-Ai Rd., Sec 1 Ste-Foy QC G1V 5B3 Canada Taipei,Taiwan 418-650-5115, poste 5216 886-2-2351-7729 [email protected] [email protected]
Joseph Losos Bruce Lourie Institute of Population Health Ivey Foundation President University of Ottawa York University 1 Stewart Street 11 Church St, Suite 400 Ottawa ON K1N 6N5 Canada Toronto, Ontario CANADA 613-562-5800, ext. 2579 416-867-9229 [email protected] [email protected]
10 Gail Lundell Marko Markov Electronic Power Research Institute Research International 3412 Hillview Avenue 135 Arielle, Suite E Palo Alto, California Williamsville, NY USA 14221 USA 650-855-7956 716-636-1132 [email protected] [email protected]
Eva Marsalek R. Scott Marsh PMI EPCOR Distribution Inc. Lenaugasse 36 10065 Jasper Avenue 3400 Klosterneuburg-Kierling Edmonton AB T5J 3B1 Austria Canada 43-2243-847366 780-412-3334 [email protected] [email protected]
Marco Martuzzi World Health Organization Heather McLeod-Kilmurray via F. crispi, 10 Assistant Professor 00187 Rome, Italy Faculty of Law 39-06-4877520 University of Ottawa [email protected] 57 Louis Pasteur Ottawa, Ontario K1N 6N5 CANADA [email protected]
Jill R. Meara Bill McVeigh Centre for Radiation ENMAX Power Corporation Chemical and Environmental Hazards 8820 52 St SE Radiation Protection Division Calgary AB T2C 4E7 Health Protection Agency Canada Chilton, Didcot 403-514-3741 Oxfordshire UK [email protected] 44-1235-831600 [email protected]
11 David Mildenberger Manager, Power Quality and Metering Robert Mercier EMF Issues Manager Connecticut Siting Council Altalink Management Ltd. Ten Franklin Square P.O. Box 20, Station M New Britain, CT 06051 1035 - 7th Avenue SW 860-827-2935 Calgary AB T2P 2G9 Canada [email protected] 403-267-3458 [email protected]
Michael Milligan Hiroaki Miyagi Mobile Manufacturers Forum Consultant Diamant Building Blvd. A. Reyers 80 Environmental Risk Assessment Unit Brussels 1030 Japan NUS Co., Ltd. (JANUS) Belgium Kaigan 3-9-15-7F, Minato-ku 32-2706-8567 Tokyo 108-0022, Japan [email protected] 81-3-5440-1865 [email protected]
Lars Mjones Deborah Moir Swedish Radiation Protection Authority Chief, Radiation Surveillance and Health Assessment Programme Mamager Division Radiation Protection Bureau SE-171 16 Stockholm 775 Brookfield Road Sweden Ottawa, ON K1A 1C1 46-8-729-7100 613-954-6672 [email protected] [email protected]
David Morley, Senior Policy Advisor Phyllis Morris Office of the Minister of State for Infrastructure and Municipality of Markham/Aurora, Aurora's Communities Environmental Advisory Committee, Hydro Task Force 215 Bruyere 10 Timpson Drive Ottawa, Ontario CANADA Aurora, Ontario CANADA K1N 5E4 L4G 5K6 613-558-6756 905-727-3123, ext. 4267 [email protected] [email protected]
12 Michelle Morrissey-O'Ryan Sung Ho Myung Hydro One Korea Electrotechnology Research Institute 483 Bay Street, 14th Floor, North Tower Seang Ju Dong 28-1 Toronto, Ontario CANADA Chang Won City M5G 2P5 Kyung Nam, Republic of Korea 416-345-6734 Chang Won City [email protected] 82-55-262-2395 [email protected]
Hughes Nappert Seema Nagpal Industry Canada Canadian Medical Association 365 Laurier Ave. W 1867 Alta Vista Drive Ottawa ON Ottawa, Ontario CANADA Canada K1G 3Y6 613-991-0031 613-731-8610 [email protected] [email protected]
Tarcisio Neves da Cunha Ken Ogilvie Brasilian Ministry of Health Executive Director SAS Quadra 04 Bloco N Sala 1004 Pollution Probe Setor de Autarquias Sul 625 Church Street, Suite 402 Brasilia DF Toronto, ON Brazil M4Y 2G1 Canada Setor de Autarquias Sul 416-926-1907 55-61-9291-6587 [email protected] [email protected]
Kendra Okonski International Policy Network Tracey O’Sullivan 3rd Floor, Bedford Chambers Women’s Health Research University The Piazza Institute of Population Health London, UK University of Ottawa WCZE8HA 1 Stewart Street The Piazza Ottawa ON K1N 6N5 Canada 4420-7836-0750 613-562-5800, ext. 2646 [email protected] [email protected]
13 Vera Pachner National Defence Greg Paoli DND QETE Decisionalysis Risk Consultants, Inc. Quality Engineering Test Establishment 1831 Yale Avenue 101 Colonel By Drive Ottawa, ON K1H 6S3 Ottawa ON K1A 0K2 Canada Canada 613-260-1424 819-994-8130 [email protected] [email protected]
Christiane Pölzl Federal Office for Radiation Protection Kevin Pottie Ingolstädter Landsh 1 Institute of Population Health Obserschleibheim University of Ottawa Germany 1 Stewart Street 49-1888-333-2744 Ottawa ON K1N 6N5 Canada [email protected] 613-562-5800, ext. 2461 [email protected]
Christine Power CFIA Greg Quan 3851 Fallowfield Rd, PO Box 11300 BC Hydro Ottawa, Ontario CANADA 6911 Southpoint Drive (12th Floor) K2H 8P9 Burnaby, BC CANADA 613-228-6698, ext. 5945 604-528-1517 [email protected] [email protected]
Michael H Repacholi Jack Rowley Coordinator, Radiation & Environmental Health Director Research & Sustainability GSM Association Protection of the Human Environment World Health HQ, Block 2, Third Floor, Deansgrange Business Park Organization 20 Avenue Appia Deansgrange, Co. Dublin CH-1211 Geneva 27 Ireland Switzerland 353 1 289 1823 41 22 791 34 27 [email protected] [email protected]
14 Jose Antonio Simas Bulcao Glenn Sias Ministerio de Minas e Energia - Furnas Centrais Southern California Edison Company Electricas 1721 22nd Street Rua Deal Grandeza 219, Botafogo Santamonica, CA Divisao de Epidemiologia e Prevencao do 310-315-3234 Departamento de Saude, Bloco C, Sala 1407 [email protected] Rio de Janeiro, Brasil 055-21-2528-4104 [email protected]
Brad Sandberg Intel Corporation 2111 NE 25th Avenue Hillsboro, Oregon Norm Sandler 97124-5961 Mobile Manufacturers Forum 503-264-1170 [email protected]
Tomonori Shiraishi Koo-Yong Shin Tokyo Electric Power Company (TEPCO) Daejeon Yusung-Gu 103-16 Munji-Dong 1-3 Uchisaiwai-Cho 1-Chome Korea Electric Power Research Institute Chiyoda-Ju Tokyo Korea 100-8560 Japan 82-42-865-5853 81-3-4216-3896 [email protected] [email protected]
Jorge Skvarca Ministry of Health, WHO James M. Solyst (Jim) WHO Advisory Panel on Radiation Senior Director, Science Policy Moreno 1652 American Chemistry Council CP 1093, Buenos Aires 1300 Wilson Blvd. Argentina Arlington, VA 22209 54 11 4620 1759 703-741-5233 [email protected] or [email protected] [email protected]
15 Jang Suk-Han John Swanson Korea Electric Power Corporation (KEPCO) National Grid Transco Transmission Construction Dept., KEPCO 167 1-3 Strand Samseong- Dong London WC2N 5EH Gangham-Gu, Seoul, 135-791 United Kingdom Republic of Korea 44 20 7004 3134 82-2-3456-5112 [email protected] [email protected]
Art Thansandote Suzanne Thérien Health Canada Assistant to the Director 775 Brookfield Road McLaughlin Centre for Population Health Risk Ottawa ON K1A 1C1 Assessment, University of Ottawa Canada 1 Stewart Street 613-954-0306 Ottawa ON K1N 6N5 Canada [email protected] 613-562-5381 [email protected]
Emilie van Deventer Michael Tyshenko Scientist Project Coordinator Radiation & Environmental Health McLaughlin Centre for Population Health Risk Protection of the Human Environment Assessment, University of Ottawa World Health Organization 1 Stewart Street 21 Avenue Appia Ottawa ON K1N 6N5 Canada CH-1211 Geneva 27 613-562-5800, ext. 2311 Switzerland [email protected] 41 22 791 3950 Email: [email protected]
Kim J. Vicente Teri L. Vierima Professor, P. Eng. EMF Gateway Director, Cognitive Engineering Laboratory 22 N. Carroll Street, Suite 300 Department of Mechanical & Industrial Engineering Madison,, WI 53703 University of Toronto USA 5 King's College Road 608-251-8767 Toronto, Ontario M5S 3G8 Canada [email protected] 416-978-7399 [email protected]
16 Jeanette Ward Hilary Walker Director Department of Health Institute of Population Health Skipton House University of Ottawa Room 683D, 80 London Road 1 Stewart Street Elephant and Castle Ottawa ON K1N 6N5 Canada London, UK 613-562-5660 207-972-5122 [email protected] [email protected]
Qiuying Yang Soichi Wazanabe McLaughlin Centre for Population Health Risk National Institute of Information and Communications Te Assessment, University of Ottawa Nukui-Kiramachi 4-2-1 1 Stewart Street Koganei, Tokyo Ottawa ON Japan Canada 81-42-327-6512 613-562-5280 [email protected] [email protected]
Maged Younes Director Soichi Wazanabe Office of the Assistant Director General National Institute of Information and Communications TechnologySustainable Development and Healthy Environments Nukui-Kiramachi 4-2-1 World Health Organization Koganei, Tokyo 20, Avenue Appia Japan CH-1211 Geneva, Switzerland 81-42-327-6512 Tel: +41-22-791 3574 [email protected] [email protected]
Joseph Zayed Full Professor Department of environmental and occupational health Faculty of Medicine University of Montreal C.P.6128, succursale Centre-ville Montréal, Québec, Canada Tél: 514-343-5912 [email protected]
1 APPENDIX B - MEETING AGENDA & SPEAKER BIOGRAPHIES
2 Workshop on Guiding Public Health Policy in Areas of Scientific Uncertainty Conference Program and Speakers’ Biography
The workshop objectives are to (1) to review a draft framework for guiding public health policy in areas of scientific uncertainty, (2) to explore the use of various measures to guide public health policy, (3) to discuss the implications of the implementation of the draft framework with stakeholders, and (4) to explore the use of the framework through a series of relevant case studies.
Monday July 11, 2005 Introduction and Objectives
9:15 –9:30 am Welcome Jeannette Ward, University of Ottawa
In April 2005, Jeanette Ward was appointed as Director of the Institute of Population at the University of Ottawa. She also has an appointment as Full Professor in the Department of Epidemiology and Community Medicine. Jeanette brings extensive experience in academia, service and administration to her position at the University of Ottawa.
Her career in population health began in family practice in Sydney, Australia. She then combined part-time clinical work with her studies in medical education at Masters’ level that focussed on continuing medical education. Jeanette’s doctoral research in cervical screening in general practice then paired her interest in women’s health with the need to discover better ways of supporting the delivery of preventive care to the community.
In 1994, Jeanette commenced as inaugural Director of the Needs Assessment & Health Outcomes Unit (NAHOU) in Central Sydney Area Health Service. NAHOU was conceptualised as the first service-based public health research unit in the NSW public health system. Under her leadership, NAHOU soon became an acclaimed success. Similar units dedicated to research and evaluation then were established in other health services.
In 2001, Jeanette accepted the position of Area Director of the Division of Population Health for South Western Sydney Area Health Service. In this role, Jeanette was responsible for a suite of population health services provided to a population of approximately 800 000, including health promotion, women’s health, migrant health, drug and alcohol, health protection and environmental risk management, community paediatrics and Aboriginal health. Jeanette left her mark in South Western Sydney through strategic initiatives to build capacity, increase resources and engage the community in population health perspectives.
9:30 –9:45 am Opening Remarks David Butler-Jones, Chief Public Health Officer,
Public Health Agency of Canada
Dr. David Butler-Jones, Canada's first Chief Public Health Officer, heads the newly created Public Health Agency of Canada, providing leadership on the government's efforts to protect the health and safety of Canadians. He has served as Medical Officer of Health for Algoma District and Simcoe County in Ontario as well as Medical Health Officer for Sun Country and Consulting Medical Health Officer for Saskatoon Health Regions in Saskatchewan. He is also an Associate Clinical Professor with the Faculty of Medicine at the University of Saskatchewan and has taught at both the undergraduate and graduate levels.
From 1995 to 2002, Dr. Butler-Jones was Chief Medical Health Officer for the Province of Saskatchewan and Executive Director of the Population Health and Primary Health Services Branch for the province. He has worked in
1 many parts of Canada and has experience with consultations and work exchanges in places as diverse as the Dominican Republic, Turkey, Scotland, Brazil, Kosovo, and Chile.
Dr. Butler-Jones has served as: President, Canadian Public Health Association and current Executive Board member; Vice President, American Public Health Association; Chair, Canadian Roundtable on Climate Change and Health 2000; International Regent, American College of Preventive Medicine; Member, Governing Council for the Canadian Population Health Initiative; Chair, National Coalition on Enhancing Preventive Practices of Health Professionals; Co-Chair of the Canadian Coalition for Public Health in the 21st Century.
9:45 –10:30 am International EMF Project and Workshop Objectives Mike Repacholi, World Health Organization
Dr. Repacholi is Coordinator, Radiation and Environmental Health Unit of the World Health Organization, Geneva, Switzerland, with responsibility for WHO's radiation health programmes since 1996; B.Sc. (Physics) University of Western Australia, M.Sc. (Radiation Biology) London University, United Kingdom, and Ph.D (Biology) Ottawa University, Canada. (1980); Past Chairman and Chairman Emeritus of the International Commission on Non- Ionizing Radiation Protection (ICNIRP); Participant in 12 World Health Organization task groups on various NIR; Member of the UK Expert Committee on Mobile Telephone Technology established by the UK Minister of Public Health and member of the Program Management Committee (PMC) of the UK Mobile Telecommunications Health Research Program; Fellow and Past President of the Australian Radiation Protection Society; Fellow and Past President of Australasian College of Physical Scientists and Engineers in Medicine; Fellow of the Australian Institute of Physics; Member of the Health Physics Society, and Member of the Bioelectromagnetics Society; and author or co-author of over 200 scientific publications.
10:30 –10:45 am Coffee Break
Introduction to the Framework
10:45 –11:15 am A Framework for guiding public policy in areas of scientific uncertainty Emilie van Deventer, World Health Organization
Dr. Emilie van Deventer-Perkins is an electrical engineer with a career interest in electromagnetic fields. She received her PhD from the University of Michigan, USA in 1992. Dr van Deventer works as a scientist at the World Health Organization (WHO) in Geneva, Switzerland in the Radiation and Environmental Health (RAD) unit within the department of Protection of the Human Environment (PHE) of WHO. Her activities focus on the development of scientific documents, policy frameworks and information brochures relating to public health protection from non- ionizing radiation. She participates in various scientific and public meetings to discuss the position of the WHO International EMF Project on health effects from electromagnetic fields.
Dr van Deventer is currently on leave of absence from the University of Toronto in Canada where she is a Professor of Electrical Engineering. Her academic research has been focused on high frequency electromagnetic fields for telecommunications applications.
11:15 –11:30 am Protecting public health: A European perspective Marco Martuzzi, World Health Organization, European Regional Office
Marco Martuzzi is an epidemiologist with experience in environmental and occupational studies. He has worked at the Italian Institute of Health, the London School of Hygiene and Tropical Medicine, the Imperial College School of Medicine, before moving to WHO, first at the International Agency for Research on Cancer (Lyon) and over the last six years at the European Centre for Environment and Health, Rome Division. He has experience in methods and applications of descriptive and geographical studies in non-communicable disease epidemiology, which were the subject of his PhD obtained from the University of London in 1996. His recent areas of work is on the health effects and the health impact of several environmental factors including air pollution, asbestos, waste, electromagnetic
2 fields and socio-economic determinants. He is responsible for the programme Health Impact Assessment Methods and Strategies, which contributes to supporting WHO’s European Member States in decision making on environment and health matters, especially through the series of Ministerial Conferences on Environment and Health.
11:30 –12:00 pm Discussion of Framework (Questions)
Lunch 12:00 –1:00 pm Lunch (will not be provided, a map of nearby restaurants will be available)
Discussion of Framework elements
1:00 –1:30 pm Putting health issues into context Maged Younes, World Health Organization
Maged Younes holds a MSc and a PhD degree in Biochemistry/Physiological Chemistry from the University of Tübingen, Germany, and a DSc in Toxicology and Biochemical Pharmacology from the Medical University of Lübeck, Germany. He is currently Director, Office of the Assistant Director-General, Sustainable Development and Healthy Environments, WHO.
Dr. Younes started his career as a researcher and Professor of Toxicology and Biochemical Pharmacology in Germany, before joining the German Federal Health Office and WHO. In his career with WHO, Dr Younes has dealt with various aspects of environmental health policy and management, and has led various multidisciplinary teams on several environmental health issues. He has managed groups dealing with risk assessment (including burden of disease and cost-effectiveness of interventions assessment), chemical safety (including food chemicals), cross-cutting environmental health issues, and occupational health. he has performed work on establishing linkages between science and environmental health policies, on ensuring coordination with other international bodies and NGOs, and on providing policy advice to counterparts in Member States. He is an Adjunct Professor of Toxicology/Biochemical Pharmacology at the Medical University of Lübeck, Germany, and a Visiting Professor with the Postgraduate Programme on Environmental Toxicology, Technology and Management, a joint degree programme of Mahidol University, Chulabhorn Research Institute and Asian Institute of Technology, Bangkok, Thailand. Dr. Younes has published 135 original papers and 38 review articles/book chapters, and has edited/co- edited 6 books and special journal issues. He has made numerous oral presentations, plenary lectures, poster demonstrations, invited lectures and seminars
1:30 –2:00 pm Option generation and cost effective analysis John Swanson, National Grid, UK
John Swanson is a physicist by training, with first degree and doctorate at the University of Oxford. He has worked on the EMF issue for the National Grid, the UK’s electricity transmission company, for 15years, initially just on exposure issues but increasingly on epidemiology, communications, and policy issues as well. He was involved in initiating the UK’s stakeholder process for considering precautionary approaches to EMFs. He was an observer at the 2001 IARC meeting which considered EMFs and has participated in several of the meetings leading to the draft WHO Framework.
3 2:00 –2:30 pm Public perception Louise Lemyre, University of Ottawa
Dr. Louise Lemyre, Ph.D. is a Full Professor at the School of Psychology and the McLaughlin Research Chair on Psychosocial Aspects of Risk and Health at the Institute of Population Health of the University of Ottawa, where she leads a research unit on psychosocial analysis of health ‘GAP-Santé’. She obtained her Master's degree from UBC and her doctorate at Université Laval in Social Psychology. She then went for an interdisciplinary postdoctorate in social epidemiology and medical sociology at the British MRC Social Research Unit at the University of London, UK. Funded by SSHRC since 1989, her work involves developing unique qualitative and quantitative methodologies for the triangulation between subjective appraisal and contextual evaluation of social environment, especially with respect to stress, adaptation and organizational learning, in either health or work settings. Scientist of the R.S. McLaughlin Foundation, her interdisciplinary projects involve the major determinants of population health and their interaction, especially as they relate to Sense of Mastery, Uncertainty and Threat. The psychosocial aspects of terrorism, emergency preparedness and psychosocial management of risks are at the core of her applied research program.
2:30 –3:00 pm Coffee Break
3:00 –3:30 pm Scientific risk assessment and uncertainty Greg Paoli, Decisionalysis Risk Consultants, Inc, Ottawa Greg Paoli leads a small consulting firm specializing in public health risk analysis. He has experience in diverse risk management domains such as food and water safety including toxicological and microbial hazards, animal and plant health, natural hazards and climate change impact assessment, air quality, business continuity planning, emergency management as well as comparative risk assessment across diverse hazards and outcomes (e.g., health and economic). In many of these subject areas, Greg has provided services spanning the analytical, communication and decision-support aspects of risk management. He holds a Master’s Degree from the University of Waterloo in Systems Design Engineering.
Greg has served on a number of expert panels addressing health risk assessment including those convened by the U.S. National Academy of Sciences (Institute of Medicine), the World Health Organization, the Institute of Food Technologists and other international organizations. He has recently been appointed to Health Canada’s Expert Advisory Committee on Antimicrobial Resistance Risk Assessment. In addition to consulting, Greg provides training to numerous organizations in risk management and in the theory and techniques of risk assessment. He currently serves as part of the continuing education faculty for the Harvard School of Public Health’s Course on Probabilistic Risk Assessment.
3:30 –4:00 pm Action Implementation and Evaluation Maged Younes (see page 4 for bio)
4.00 - 4.30 pm Legal aspects of using precaution Heather McLeod-Kilmurray, Assistant Professor, Faculty of Law, University of Ottawa
Heather McLeod-Kilmurray is an Assistant Professor at the Faculty of Common Law, University of Ottawa. She clerked to Chief Justice Isaac of the Federal Court of Appeal, and was a lawyer for the Federal Department of Justice at Environment Canada. Her current research deals with courts, the rules of civil litigation, and their operation in environmental law. She teaches Torts, Environmental Law and Fondements de la common law. She has recently collaborated on a research project entitled “Practicing Precaution: Legal, Institutional and Procedural Dimensions of Scientific Uncertainty” for the Law Commission of Canada, with colleagues from the Faculty of Common Law and the Institute of the Environment of the University of Ottawa.
4 4:30 –5:30 pm Discussion of Framework
5:30 –7:00 pm Reception (Cash bar with snack food available)
Tuesday July 12, 2005
Case studies to test the Framework
9:00 –9:30 am Electromagnetic Fields Mike Repacholi, World Health Organization (see page 2 for bio)
9:30 –10:00 am Risk Management Decision Making: BSE William Leiss, University of Ottawa.
Professor, School of Policy Studies, Queen’s University (1994-); Visiting Professor, Haskayne School of Business, University of Calgary; Scientist, McLaughlin Centre for Population Health Risk Assessment, University of Ottawa. William Leiss is a Fellow and Past-President (1999-2001) of the Royal Society of Canada and an Officer in the Order of Canada. From 1999 to 2004 he was the NSERC/SSHRC Research Chair in Risk Communication and Public Policy in the Faculty of Management, University of Calgary. This five-year chair program, with total funding of $1.25 million, was part of the MOTC (Management of Technological Change) strategic grants program; a consortium of Alberta-based industrial sponsors from the chemicals and petroleum sectors provided one-half of the chair funding.
From 1994 to 1999 he held the Eco-Research Chair in Environmental Policy at Queen's University, Kingston, Ontario, where he is also Professor in the School of Policy Studies. The five-year Eco-Research Chair program was funded at a total of $1.3 million by the Tri-Council Secretariat (using funds from Environment Canada) and Imperial Oil Ltd. His earlier positions were in political science (Regina, York), sociology (Toronto), environmental studies (York), and communication (Simon Fraser). At Simon Fraser he was also Vice President, Research.
He was the founding Chair of the Committee on Expert Panels of the Royal Society of Canada, established in November 1995. This Committee is charged with developing in Canada a consistent and credible procedure for the conduct of expert panel processes, which are used to provide definitive judgments on the state of scientific knowledge relative to issues in the management of health and environmental risks.
He is author, collaborator or editor of twelve books and numerous articles and reports. His most recent book, In the Chamber of Risks: Understanding Risk Controversies, was published by McGill-Queen's University Press in November 2001; it includes risk management case studies of genetically-modified foods, radio-frequency fields, pulp mill effluent, MMT, genetic engineering, voluntary initiatives, and CEPA.
Two earlier volumes on risk themes are Mad Cows and Mother's Milk: The Perils of Poor Risk Communication (co- authored with Douglas Powell, 1997; second edition with three new chapters, 2004) and Risk and Responsibility, 1994 (both from McGill-Queen's University Press). They contain detailed case studies of controversies over environmental and health risks in Canada and elsewhere, including: pesticides, electric and magnetic fields, food risks ("mad cow" disease, "hamburger disease"), chemicals (dioxins, PCBs), silicon breast implants, agricultural biotechnology, and bovine growth hormone. Earlier books include The Domination of Nature (1972), The Limits to Satisfaction (1976), Social Communication in Advertising (1986, 1990), C. B. Macpherson (1988), and Under Technology's Thumb (1990), all of which are currently in print.
Over a period of fifteen years he has worked extensively in a consulting capacity with industry and with Canadian
5 federal and provincial government departments in the area of risk communication, risk management, public consultation, and multi-stakeholder consensus-building processes. He has been an advisor on issues dealing with pesticides, toxic chemicals (chlorine, dioxins, and others), tobacco, prescription drugs, electric & magnetic fields, genetic engineering, and others.
10:00 –10:30 am Food Safety (GMO) Peter Ben Embarek, World Health Organization
Peter K. Ben Embarek has a MSc. degree in Food Science and Technology and a PhD in Food Safety from the Royal Agricultural and Veterinary University of Copenhagen, Denmark. After several years of research focused on safety aspects of fishery products, he joined in 1995 The Food and Agriculture Organization of the United Nations (FAO) at the regional Office for Asia and the Pacific in Bangkok where he coordinated research and development activities and provided technical advise on safety and quality aspects of fishery products. In 1997, he joined the Fisheries Department of FAO HQ in Rome where he was involved with food safety aspects of fishery products. In 2001, he joined the Food Safety Department of the World Health Organization (WHO) at its HQ in Geneva where he is responsible for the microbiological aspects of food safety matters in the work of the Organization. In recent years he has covered food safety issues as part of the WHO response efforts to new emerging public health issues such as SARS and Avian influenza. He contributed to the development of the FAO/WHO guidelines on strengthening national food control systems. Since 2002, he has participated in WHO missions to several countries including PR of China and Thailand to develop national food safety strategies and action plans. These action plans are providing the basis for future integrated food safety developments in these countries. Similar approaches towards strengthening food safety systems in other countries are planned for the coming years. Since 1999, He has been closely involved in the development of the work on microbiological risk assessment in FAO and WHO and in presenting outcomes of these risks assessments.
10:30 –10:45 am Coffee Break
10:45 –11:15 am Climate Change Philippe Crabbé, University of Ottawa
Professor Emeritus of Natural Resources and Environmental Economics, Department of Economics, University of Ottawa, has extensive interdisciplinary experience with climate change science and policy through his work for the Intergovernmental Panel on Climate Change (Third and Fourth Assessments, WG III), for the Analysis and Modeling Group of the National Climate Change Process (Advisory Committee), for C-CIARN, Ontario node (Advisory Committee) and his consulting work over several years for Health Canada on risk management for climate change (CC). Crabbé also has extensive experience with Eastern Ontario (EO) and stakeholders’ involvement, first through a Green Plan Ecoresearch project (1993-1996), an integrated environmental assessment of the Upper St. Lawrence in EO, and through the past (2000-2003) Municipal Institutional Adaptation to Climate Change for water resources in EO funded by the Social Sciences and Humanities Research Council (SSHRC), Community University Research Alliance (CURA) program. Portion of the final report of this project is forthcoming (subject to minor editing) by Climatic Change. Crabbé, who was the first director of the University of Ottawa Institute of the Environment for 9 years, has recently edited a book on Ecological Integrity, published by the NATO Science Research series, and written on sustainable development, fishery, forestry, mining and irreversible decisions. He is currently teaching courses on sustainable development and environmental economics, and on complex systems. He sits on the Advisory Stakeholders’ Committee for the Environmental Commissioner of Ontario. He is the alternate representative of the University of Ottawa on the Eastern Ontario Water Resources Committee. He has written a review paper on communities for the Canadian Climate Impact and Adaptation Research Network. He also has been a member for the last eight years of an international informal multidisciplinary research group on Ecological Integrity, which has little to do with climate change but a lot with both Canadian and world environmental problems including human health.
11:15 - 11:45 am Pandemic Influenza
6 Paul Gully, Public Health Agency of Canada
Dr. Gully is the Deputy Chief Public Health Officer, Public Health Agency of Canada . In this position, he works with the Chief Public Health Officer in the management of the Agency to enable it to fulfill its mission and mandate. Dr. Gully joined Health Canada in 1990 and subsequently held a number of positions within the former Laboratory Centre for Disease Control, Health Protection Branch. In July 2000, he was appointed the first Director General of the new Centre for Infectious Disease Prevention and Control, PPHB and in March 2002, he was appointed Senior Director General of the Population and Public Health Branch.
Dr. Gully is a physician with specialty training in public health in the United Kingdom and Canada. Prior to training in public health, he worked in the United Kingdom (UK), Zambia, Vancouver and the Northwest Territories. Before joining Health Canada, Dr. Gully was attached to the UK Communicable Disease Surveillance Centre. He was also Medical Officer of Health in Saskatoon from 1986-1990. Dr. Gully has written several publications on infectious disease epidemiology and has held honorary and adjunct academic positions in the UK and Canada. He was past- president of the National Specialty Society for Community Medicine.
Lunch 11:45 - 1:00 pm Lunch (will not be provided, a map of nearby restaurants will be available)
Case Studies - continued
1:00 –1:30 pm Radon Case Study Daniel Krewski, University of Ottawa
Professor and Director of the R. Samuel McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa, where he is involved in a number of activities in population health risk assessment within the Institute of Population Health. Dr. Krewski has also served as Adjunct Research Professor of Statistics in the Department of Mathematics and Statistics at Carleton University since 1984. Prior to joining the Faculty of Medicine at the University of Ottawa in 1998, Dr. Krewski was Director, Risk Management in the Health Protection Branch of Health Canada. While with Health Canada, he also served as Acting Director of the Bureau of Chemical Hazards and as Chief of the Biostatistics Division in the Environmental Health Directorate. Dr. Krewski obtained his Ph.D. in statistics from Carleton University and subsequently completed an M.H.A. at the University of Ottawa. His professional interests include epidemiology, biostatistics, risk assessment, and risk management.
Dr. Krewski is a Lifetime National Associate, U.S. National Academy of Sciences (2002); Member, U.S. National Academy of Sciences Board on Nuclear and Radiation Studies (2005-2008); IARC Workshop Group Member on the Carcinogenicity of Polycyclic Aromatic Hydrocarbons (2005-2006); IARC Workshop Group Member on on the Avoidable Causes of Cancer (2005-2006); IARC Workshop Group Member on Cancer Working Group on Carcinogen Classification (2005-2006); Chair, U.S. National Academy of Sciences Committee on Toxicity Testing and Risk Assessment (2004-2007); Chair, U.S. National Academy of Sciences Committee on Acute Exposure Guidelines for Highly Hazardous Substances (1998-2004); Member, U.S. National Academy of Sciences Board on Radiation Effects Research (2002-2004); Member, U.S. National Academy of Sciences Committee on the Biological Effects of Ionizing Radiation (BEIR VII, 2000-present; BEIR VI, 1994-1999); Chair, Royal Society of Canada Expert Panel on the Potential Health Risks of Radiofrequency Fields from Wireless Telecommunications Devices (1998-1999); Member, U.S. National Academy of Sciences Board on Environmental Studies and Toxicology (1996- 2002); Member, Scientific Council of the International Agency for Research on Cancer (1992-1996); Fellow, Society for Risk Analysis (1993); Fellow, American Statistical Association (1990). Dr. Krewski received Inaugural American Industrial Health Council Visiting Scholar at the CIIT Centers for Health Research (2005).
1:30 –2:00 pm Walkerton Case Study Kim Vicente, University of Toronto
7 Kim J. Vicente received his PhD (1991) in Mechanical Engineering from the University of Illinois. He is professor of Mechanical & Industrial Engineering at the University of Toronto, and founding director of its Cognitive Engineering Laboratory. He is a Senior Fellow of Massey College, and received the Premier’s Research Excellence Award, the University of Toronto McLean Award, and the NSERC E.W.R. Steacie Fellowship. During 2002-2003, he was Jerome Hunsaker Visiting Professor at MIT. His latest book, The Human Factor: Revolutionizing the Way People Live With Technology (2003), received the National Business Book Award and the Science in Society General Audience Book Award.
2:00 –2:30 pm MMT Case Study Joseph Zayed, Université de Montréal
Mr. Zayed, who has a doctorate in public health, with a specialization in environmental toxicology, is currently a full professor at the Université de Montréal, where he is also the Director of Graduate Studies with a specialization in Environment and Prevention.
In 1995, Mr. Zayed obtained the Université de Montréal award of merit for teaching. From 2001 to 2004, he was the Director of the Centre Interuniversitaire de Toxicologie and from 2003 to 2004, he chaired the steering committee of the Canadian Network of Toxicology Centres. His research and publications concern the assessment of environmental contamination and of industrial and general exposure, as well as the estimation of health risks associated with chemical substances, more specifically manganese and beryllium. Mr. Zayed has also been an international scientific evaluator for a number of research studies on metal toxicology.
As a part-time member of the BAPE, Mr. Zayed has been a commissioner for five mandates and a Chair of six other mandates.
2:30 –2:45 pm Coffee Break
Stakeholder Viewpoints
[This session will allow for 15 minute presentations by relevant stakeholder sharing experiences relating to the Framework elements]
2:45 –3:00 pm Ken Ogilvie, Pollution Probe, Toronto, Canada Ken Ogilvie is the Executive Director of Pollution Probe, one of Canada’s most distinguished environmental groups. Ken joined Pollution Probe in October 1995 after serving for almost two years as the Executive Coordinator of the Ontario Round Table on Environment and Economy. His position previous to that was Manager of Policy Coordination for the Ontario Ministry of Environment and Energy. He has also worked for Environment Canada and the Manitoba Department of the Environment. Ken has 30 years of experience in government, institutional and not-for-profit organization positions, ranging from project engineering to policy development and public advocacy. He has had international experience as the Acting Director of the federal Great Lakes Program and as a lecturer on sustainable development institutions, tools and techniques. He is also actively involved in environmental standard- setting work, especially work related to the ISO 14000 series of environmental management standards. Ken’s academic credentials include a Bachelors of Applied Science (Civil Engineering), University of Waterloo, and a Masters of Business Administration, York University.
3:00 –3:15 pm Geoff Granville, Shell Canada, Edmonton, Canada Geoff has worked for 32 years for Shell, initially as an experimental toxicologist in the UK. He came to Canada on a temporary assignment in 1981 and is still here - he just refused to leave! Except for a 2-year assignment with Health Canada in the early 1990s (an experience that he highly recommends), he has been the Manager, Toxicology and Product Stewardship for Shell Canada for the past 20 years. His responsibilities include managing and advising on a broad range of occupational and environmental health issues relating to chemical substances, including toxicity testing, health risk assessments and regulatory compliance. His particular interests include the health effects of air
8 pollution, the toxicology and risks of chemical substances such as benzene and hydrogen sulfide, prioritization and communication of population health risks, and the regulation of chemical substances. He is an adjunct professor at two Canadian Universities: Alberta and Toronto.
3:15 –3:30 pm Dennis Erpelding –Elanco U.S. Office Dennis L. Erpelding was named Manager, Elanco Government Relations, Public Affairs and Communications in October 1997. He coordinates the strategic direction of these activities on a global basis with a primary focus on the United States and Canada; working with an international team to implement regional initiatives. Additionally, Mr. Erpelding is the media spokesperson for Elanco Animal Health. Mr. Erpelding joined the Elanco Animal Health division of Eli Lilly and Company in 1989 where he has held positions in market development, public information, industry affairs, marketing, government relations and poultry products sales management.
A native of Whittemore, Iowa, Mr. Erpelding was raised on a diversified livestock and crop farm. He received a Bachelor of Science degree in dairy science from Iowa State University and a Masters of Business Administration degree from The Ohio State University.
Mr. Erpelding has extensive global experience managing strategy and implementation of government relations, public affairs and communications initiatives addressing biotechnology, antibiotics, hormones and beta-agonists. He has directly engaged with government officials and stakeholders in over twenty countries including European Union member states, Japan and the United States.
Globally, Mr. Erpelding served as an expert at the Second Joint FAO/OIE/WHO Expert Workshop on Non-Human Antimicrobial Usage and Antimicrobial Resistance: Management options, 15–18 March 2004, Oslo, Norway; as a delegate for the International Federation for Animal Health at Codex meetings; and presented and participated at numerous international, regional and national meetings relating to antimicrobial resistance and various aspects of risk analysis. Mr. Erpelding has extensive experiences with global organizations including the World Health Organization (WHO), the Food and Agriculture Organization (FAO), the World Organization for Animal Health (OIE) and the Codex Alimentarius Commission.
Mr. Erpelding is Vice Chair of the U.S. Meat Export Federation, and serves on the Executive Committee and Boards of the U.S. Meat Export Federation and the Animal Agriculture Alliance. He is also on the Operating Committee of the Agri-Business Educational Foundation and a past Board member of the Agriculture Council of America. He is a former President of the National Agri-Marketing Association and a past Chair of the Ag Policy Group and the 1993 Issues Forum. He is former Chair of the Animal Health Institute Public Affairs Section having served as Co-Chair of the Animal Health Institute Special Project on Antibiotic Resistance, and Chairman of the Government Relations Committee, Public Information Committee and the BST Public Information Working Group.
3:30 –3:45 pm Jack Rowley, GSM Association [RF] Dr Jack Rowley is Director of Research & Sustainability at the GSM Association and is responsible for activities related to the safety of mobile communications, responsible environmental practices and the social aspects of mobile phone. His current duties include overseeing the GSM Association external 6 million euro multi-year international safety research programme, developing technical advice, supporting internal working groups and liaison with external stakeholders. Jack joined the GSM Association in 2000 and before that worked for 10 years with Telstra (Australia) primarily in the Research Laboratories, where he rose to the position of manager of radio communications research with special responsibility for safety and interference issues. Jack has more than seventy publications and presentations on the subjects of mobile communications safety and environmental issues. He holds a B. Eng. degree with first class honours from the University of Limerick (Ireland) and a Ph.D. from the RMIT University (Australia). In 1999 he was awarded the inaugural Australian Mobile Telecommunications Association Technical Achievement Award for Excellence.
9 3:45 –4:00 pm John Swanson, National Grid, United Kingdom [ELF] John Swanson is a physicist by training, with first degree and doctorate at the University of Oxford. He has worked on the EMF issue for the National Grid, the UK’s electricity transmission company, for 15 years, initially just on exposure issues but increasingly on epidemiology, communications, and policy issues as well. He was involved in initiating the UK’s stakeholder process for considering precautionary approaches to EMFs. He was an observer at the 2001 IARC meeting which considered EMFs and has participated in several of the meetings leading to the draft WHO Framework.
4:00 –4:15 pm Deborah Moir, Radiation Protection Bureau, Health Canada Deborah Moir received her Ph.D. in Chemistry from Dalhousie University, Canada in 1989. Dr. Moir is currently the Chief, Radiation Surveillance and Health Assessment Division at the Radiation Protection Bureau, Health Canada. The Division performs radioactivity surveillance, provides radiation dosimetry services and radiological health assessments and investigates health effects of radiation exposure. Prior to joining Health Canada, Dr. Moir was employed as a research radiochemist and manager with Atomic Energy of Canada Limited (AECL) and as the Associate Director at the Carlsbad Environmental Monitoring and Research Center, New Mexico State University.
4:15 –4:30 pm Jorge Skvarca, PAHO/Argentina Nationality: Slovenian and Argentine. Born (1941) in Ljubljana, Slovenija. Europe Current Mailing Address: Moreno 1652 (C.P.1093) Buenos Aires, Argentina Present Position: Adviser Department of Radiophysics, Ministry of Health and Environment, Buenos Aires, Argentina. EDUCATION ENGINEERING DEGREE: From Faculty of Engineering, National University of Buenos Aires, Electromechanical and Electronic Engineer (1976); Radiation Protection Training (México, EE.UU., Germany), 1978; Radiation Protection and Safety of Non Ionizining Radiation, (MIT - Cambridge, USA, August, 1982); Biological Effects of Non Ionizing Radiation (E.L.F.), (Erice, Italy, November, 1983); Emergency and Environmental Monitoring (EPA, Montgomery, AL, USA, 1988) TEACHING ACTIVITIES Teacher assistant in Physics from 1965 to 1992, Teacher assistant in Electronics National University of Buenos Aires from 1966 up to date. Professor in Physics, Catholic University of Argentina (1970/72) RADIATION PROTECTION PROGRAMME Former Director of Radiation Protection Division, Ministry of Health and Welfare, Buenos Aires, Argentina from 1970 to 1996. Director and Professor of more than 650 Courses and Workshops on Radiation Protection and Quality Control in Diagnostic Imaging, Radiotherapy and Non Ionizing Radiation PUBLICATIONS Manual on Standards for Safety on Radiofrequency Exposures from 100 KHz to 300 GHz. Vol. I and II (1988) Manual on Radiation Protection in Hospitals –Ministry of Health (1986) BASIC SAFETY STANDARDS WHO / PAHO / IAEA (Collaboration 1992) AWARDS AND PROFESSIONAL DISTINCTIONS Former Director of WHO Collaboration Center in Argentina for Radiation Emergency and Preparedness. Former Director of the National Center in Argentina of UNEP / WHO Global Environmental Radiation Monitoring Network (GERMON) Short Term Consultant of PAHO / WHO on Ionizing and Non Ionizing Radiation Current Member of the WHO/PAHO Expert Advisory Panel on Radiation
4:30 –5:00 pm Discussion
10 Wednesday July 13, 2005 Panel Discussion
9:00 –10:00 am Panel Discussion with selected Panelists:
Jim Solyst, American Chemistry Council, Washington, D.C. Jim Solyst is a senior director for science policy at the American Chemistry Council. In this capacity, he coordinates the Council’s domestic and international policy development, advocacy and communication activities relating to precaution, the use of science in decision-making, and risk assessment and cost benefit analysis. Mr. Solyst has previously served as the Council’s leader on information management and right-to-know and has also been involved in regulatory improvement, research and endocrine policy issues. Mr. Solyst participated in the 2002 World Summit on Sustainable Development (WSSD) in Johannesburg, South Africa, where he established a “Type 2” partnership with the U.S. National Academies and U.S. EPA to promote the use of science-based decision-making in developing countries. Prior to coming to the Council, Jim worked for the National Governors’ Association for twelve years where he served as the Director of Natural Resources Policy Studies. At NGA Mr. Solyst was responsible for a variety of environmental health and public safety issues, including risk assessment and management, and risk communication. Mr. Solyst prepared a number of reports and issue briefs advising Governors and key staff. Mr. Solyst also worked for Maryland Governor Harry Hughes and the state Department of Natural Resources.
Mr. Solyst has a Masters degree from the Ohio State University and Bachelors degree from the University of Maryland. He is a frequent guest lecturer at the Johns Hopkins School of Hygiene and Public Health and serves on the Scientific Advisory Council of the Johns Hopkins Risk Sciences and Public Policy Institute.
Kim Vicente, University of Toronto Kim J. Vicente received his PhD (1991) in Mechanical Engineering from the University of Illinois. He is professor of Mechanical & Industrial Engineering at the University of Toronto, and founding director of its Cognitive Engineering Laboratory. He is a Senior Fellow of Massey College, and received the Premier’s Research Excellence Award, the University of Toronto McLean Award, and the NSERC E.W.R. Steacie Fellowship. During 2002-2003, he was Jerome Hunsaker Visiting Professor at MIT. His latest book, The Human Factor: Revolutionizing the Way People Live With Technology (2003), received the National Business Book Award and the Science in Society General Audience Book Award.
Amir Attaran, University of Ottawa Amir Attaran is by training both an immunologist (D.Phil. Oxford) and lawyer (LL.B. Vancouver). His current research emphasizes the subject of health and development in poor countries. Current research interests include studying the scarcity of international aid for control of epidemic and pandemic diseases, criticism of policy development in international aid for health, the role of international patent law on access to medicines, and the design of tax and other legal incentives to accelerate research on diseases affecting the world’s poorest and sickest populations. His publications have appeared in the leading journals of both the legal and biomedical professions, including the Yale and Stanford Journals of International Law, The Lancet, The Journal of the American Medical Association, and others. He is also the author of a recent book (with Prof. Brigitte Granville) on access to medicines in developing countries.
Prof. Attaran has held faculty positions at the Kennedy School of Government at Harvard University and the School of Epidemiology and Public Health at Yale University. He is currently an associate fellow of the Royal Institute of International Affairs, London, and an Associate Professor in the Faculty of Law and Institute of Population Health at the University of Ottawa.
Susie ElSaadany, Public Health Agency of Canada Dr. Susie ElSaadany, BSc Math, MSc Math, PGD Math, Ph.D.( applied mathematics in public health related issues). Dr. Susie ElSaadany is the Chief of the Statistics and Risk Assessment, Blood Safety Surveillance and Health Care Acquired Infections Division, of the Centre for Infectious Disease Prevention and Control in the Population and Public Health Branch of Health Canada. She is a biomathematician/biostatistician, time series and
11 mathematical statistical analyst, and a risk assessor specializing in quantitative Risk Assessment Modelling / Rapid Response Risk Assessment.
Her work includes a special focus on risk assessment for rare and emerging diseases involving significant amounts of scientific uncertainty. Additionally, her work has treated; Viral Hepatitis, Creutzfeldt-Jakob Disease, new variant Creutzfeldt-Jakob Disease, Transmissible Spongiform Encephalopathy (TSE), Bovine Spongiform Encephalopathy (BSE), Severe Acute Respiratory Syndrome (SARS), West Nile Virus (WNV), and Chronic non-Infectious Diseases. She is responsible for the development of a National Autologous Blood Surveillance Program and a Pediatric Surveillance of Blood Utilization program, two programs to ensure quality, standardization and safety of blood use, and linking to blood conservation, disease transmission associated with transfusion, and the building of study objectives. She participates on Health Canada TSE Policy Team and the Health Canada TSE Scientific Team, addressing: identification of key issues, proposed action plans, time lines, TSE surveillance, TSE risk assessment for blood, tissues, organs, vaccines, veterinary biologics, therapeutic products, cosmetics, food, animals products and byproducts, natural health products, and feeds and fertilizers.
Dr. Susie ElSaadany is the founder and co-chair, with Dr. Antonio Giulivi, of the International Expert Advisory Group (IEAG) for risk modelling. The Statistics and Risk Assessment Section collects and analysis expert opinion from a panel of international scientific, medical, academic, statistical and epidemiological experts for the rapid risk assessment of rare and emerging disease issues.
Robert Cushman, City of Ottawa Dr. Robert Cushman has served as the Medical Officer of Health in Ottawa since 1996, and previously held the equivalent position in the Outaouais. He received an undergraduate degree from Harvard University and studied medicine at McMaster University.
Dr. Cushman has worked as a general practitioner in Northern Quebec, in rural Africa, and at the CHEO emergency room. He was instrumental in bringing 100% smoke-free workplaces and public places to the City of Ottawa in 2001. Well respected in our community as a champion of public health, he was awarded Community Leader of the Year in 2002.
As Medical Officer of Health, Dr. Cushman's responsibilities include managing the public-health department, setting priorities, handling emergencies, developing public-health programs for residents, and communicating with the public.
10:00 –10:45 am Plenary Discussion of the Framework, Chair: Daniel Krewski Strengths Weaknesses
10:45 –11:00 am Coffee Break
11:00 –11:45 am Plenary Discussion of the Framework Recommendations
Adjournment
11:45 –12:00 pm Closing Remarks Mike Repacholi, World Health Organization (see page 2 for bio)
12 APPENDIX C –JUNE 2005 DRAFT FRAMEWORK DOCUMENT
13 Framework Guiding public health policy options in areas of scientific uncertainty
Dealing with EMF
WHO/OMS
Draft for Review NOT FOR FURTHER DISTRIBUTION NOT FOR QUOTATION
For further information and comments contact:
The International EMF Project Radiation and Environmental Health Unit World Health Organization Email: [email protected]
June 2005
1 Table of Contents
Preface 3 Executive Summary 4 1. Introduction 5 1.1 Guiding principles 5 1.2 Purpose and Scope 5 2. Features of this Framework 6 2.1 Risk analysis process 6 2.2 Precaution as an overarching approach 7 2.3 Relationship to other frameworks 7 2.4 Legal context 7 2.5 Science and Policy 8 3. Applying the Framework 9 3.1 Getting started 9 3.2 Health issue in context 10 3.3 Risk assessment 11 3.4 Option generation 11 3.5 Option assessment and selection 13 3.6 Action implementation 14 3.7 Action evaluation 15 4. Discussion 15 4.1 Quantitative limits and guidelines 15 4.2 Public concern 15 4.3 Consultation strategies 16 4.4 Communication strategies 16 Appendix A: Technical considerations for cost-benefit and cost-effectiveness analysis 17 Appendix B: Case study on ELF electric and magnetic fields 19 Further reading 26
2 Preface
The World Health Organization (WHO) addresses environmental health threats that are uncertain and global in nature. Given the complexity of these risks, the need for timely preventive action, and scientific uncertainty about the risks to health, it is important to develop an approach for applying precautionary measures that is rational and practical, and consistent with public health values and its mission to promote and protect health.
As an international public health agency, WHO has always been cautious in its conclusions on health and safety issues, and has based its recommendations on sound and established scientific evidence. At the 1999 Conference of European Health Ministers, WHO was asked to take into account: “the need to rigorously apply the Precautionary Principle in assessing risks and to adopt a more preventive, pro-active approach to hazards.” As a result, WHO has been promoting discussion and debate in this field through open scientific fora. A Workshop on “Precautionary Policies and Health Protection: Principles and Applications” was held in Rome, May 2001; a Symposium entitled “Environmental Exposures, Public Health, and the Precautionary Principle” was held in Vancouver, August 2002 to discuss case studies and review developments in the field. WHO also co-sponsored the October 2002 Collegium Ramazzini’s international scientific conference, “The Precautionary Principle: Implications for Research and Prevention in Environmental and Occupational Health”.
A further WHO Workshop on "Application of the Precautionary Principle", co-sponsored by the European Commission and US National Institute for Environmental Health Sciences, was held in Luxembourg 24-26 February 2003 to develop a common framework for application of the Precautionary Principle to health issues, in particular in the context of electromagnetic fields (EMF). In the framework of the preparation of the European 4th Ministerial Conference on Environment and Health, “The Future of Our Children”, a workshop entitled “Dealing with uncertainty: how can the precautionary principle can help protect the future of our children?”, co-organized by WHO and AFSSE (French Agency for Environmental Protection) was held in Paris, 11-12 September 2003.
While WHO will continue to provide sound scientific advice on established health risk factors, this Framework has been developed to guide Member States developing measures to manage uncertain public health risks.
WHO encourages the use of rational, cost-effective and well thought-out measures based on scientific principles. These should be the driving force for the development of protective measures that restrict exposure to a given risk factor as well as indicate areas where practical measures can be identified that reduce any consequences to health.
Ultimately we do not live in a "risk-free" world. As the consequences of known risks are reduced through sound public health policies, it makes good sense to reduce exposures to potential risk factors that are not well understood by use of acceptable, science-based precautionary measures and policies.
3 Executive Summary
This section will be enlarged once the framework has been completed
4 1. Introduction
In the public health arena, priority is usually given to controlling risks that are clearly established: that is, involving risks factors with a causal relationship to known diseases. However, changing societal values and rapid technological developments produce an ever- increasing variety of agents and exposure situations whose health consequences are difficult to predict and to manage.
Waiting for conclusive evidence of a health threat has sometimes had unfortunate consequences (Gee, 2001). Therefore, where an agent is ubiquitous (e.g. electromagnetic fields in the environment) or the potential harm great (e.g. SARS), it may be reasonable to apply precaution and act with foresight, before a cause-effect relationship has been established or robustly quantified. Precaution can be integrated naturally into existing public health policy and can complement conventional disease prevention actions, which are usually taken only after a cause- effect relationship has been established.
Policies based on precaution are increasingly being used to prevent or limit exposures to agents or activities whose effects are not well understood, but which may nonetheless be harmful. The object of precautionary measures is to minimize potential risks to health while allowing for economic development, sustainability and innovation.
Recognizing that uncertainties exist in the evaluation of health issues can lead decision makers to adopt a "culture of precaution". However, care must be taken to have a due process when establishing policies based on precaution, as indiscriminate use of precautionary measures may in turn promote large disparities between national policies and ultimately increase public anxiety, foster confusion for regulators and policy makers, and provide a challenge to the free flow of trade. These factors have motivated WHO to build a framework for guiding public health policy options in areas of scientific uncertainty using a rational and well-established process.
1.1 Guiding principles This Framework has been developed using a number of guiding principles: Precaution is to be included throughout the risk analysis and policy development process and should be seen as an overarching approach Science is the fundamental basis for application of this Framework in that it seeks to identify the level of uncertainty about the health consequences of exposure to an agent. Public concern may be a trigger for implementing public health policies, though the priority is the protection of health Communication and consultation with stakeholders should occur at all appropriate stages and the transparency of the whole process should be guaranteed.
1.2 Purpose and Scope The purpose of the Framework is to provide practical guidance on a series of steps to assist WHO Member States develop their public health policies in the face of scientific uncertainty.
5 This will involve developing exposure reduction strategies and protective measures aimed at optimizing the overall benefit for society.
This Framework addresses how precaution may be included in the process of decision making through the various stages of risk assessment and management. This Framework applies primarily to electromagnetic fields (EMF).
2. Features of this Framework
2.1 Risk analysis process Most risk analysis approaches dealing with health risks include the following basic steps:
- risk profile or risk framing (characterization or prioritization of the risk factor within the overall public health context) - risk assessment (scientific evaluation of the risk factor) - risk management o generation and selection of options (what are the options for dealing with the risk factor, and how to select the best for implementation) o action or implementation of the selected option(s), and o monitoring and evaluation of actions undertaken.
This paradigm involves an iterative process, which promotes feedback and stakeholder involvement at all stages. One such analysis is described in the US Presidential/ Congressional Commission on Risk Assessment and Risk Management (1997) which splits this process into six stages, emphasizing the analysis of possible options, clarification of all stakeholders’ interests and openness in the way decisions are reached (Figure 1). This analysis is used as the basis for this Framework.
Health issue in Context
Action Risks Evaluation Evaluation
Stakeholder Participation Action Option Implementation Generation Risk profile Option Risk assessment Assessment and Selection Risk management
Figure 1: Iterative process for the Framework
6 2.2 Precaution as an overarching approach Policy action aimed at attaining high levels of health and wellbeing for current and future generations is the ultimate goal. Precaution is among the criteria to be used as a guide to pursue such a challenging objective. It has often been linked to the risk management stage only, and has been regarded as an additional process, invoked or triggered only when a certain level of evidence is exceeded. The basic premise of this Framework is that precaution should be viewed as an overarching philosophy for risk management which is to be applied to all aspects of managing an actual or potential health risk. The Framework sees the various stages as closely integrated, and precaution as an approach that informs every stage and for all risks rather than being triggered only sometimes. Each of the stages is discussed further in Section 3 below.
2.3 Relationship to other frameworks Since the early 1980's, European policy-makers have progressively adopted precautionary approaches. The European Commission has provided a critical step in describing the purpose and use of the Precautionary Principle in European policy making through a communication document (EC, 2000). It recommends that precautionary actions be proportionate to the degree of scientific uncertainty; the severity of possible harm; the size and nature of the affected population; and the cost of the actions. Where the evidence of danger is weak, regulation should usually be avoided. Continuing research may be an appropriate action to fill gaps in knowledge and ensure that the danger is not larger than what current understanding suggests. In addition, the Communication recommends transparent application of the process, and emphasizes the need for careful review of relevant scientific data. This Framework incorporates many of the guiding principles enunciated by the European Commission.
Other countries outside the European Union have incorporated precaution into their decision making processes, some in an informal way, and others using a formal approach. The Government of Canada has developed a “Framework for the Application of Precaution in Science-Based Decision Making About Risk”. This Framework outlines guiding principles for federal regulatory activity to protect health and safety, as well as the environment and natural resources. In New Zealand, the Resource Management Act (1991) requires specific considerations of risks which are defined as “of low probability but high potential impact”. In Queensland, Australia, the Precautionary Principle has recently been adopted by environmental legislation. In Switzerland, the Precautionary Principle is enshrined in law as is a well established instrument of risk analysis. In cases where there is a lack of or insufficient scientific information the risk manager decides pro or contra taking action.
2.4 Legal context In several countries, precaution has been incorporated in primary legislation as a way of managing risks to human health or the environment. Policy decisions based on precautionary measures should be taken by accountable elected representatives, and not in an ad hoc reactive manner.
Governments should provide the legal framework that provides their departments with the mandate to develop and implement policies that are mindful of the health implications, including
7 uncertain ones. This should also be extended to encouraging companies to act in a precautionary way. Within the legal framework, companies should not increase their liability for using precautionary measures, or that acting in a precautionary way does not imply that such measures are necessary to protect health, but are implemented in case future research suggests health consequences may occur.
Application of precautionary action should be relevant, effective, workable, socially acceptable and legitimate. Moreover, it should strengthen legal certainty and legal predictability. Policy measures should include any views on liability for implementation of precaution based on risk from the basic science. This should be explained clearly in any policy advice to implementation bodies. This clarifies the source of the decision and the litigation route. Policy should be produced in a form as free as possible from jargon so that there is less scope for misinterpretation by the implementing agency, in the courts or indeed by any of the stakeholders.
Where precautionary action is deemed necessary, measures should:
Be provided for and carried out in accordance with the law Not be drafted or imposed arbitrarily, i.e. in an unreasonable or otherwise discriminatory manner. Be proportional to the chosen level of protection, Be no more restrictive than necessary to achieve the intended purpose, Be subject to systematic review Be consistent with similar measures already taken Be based on an examination of the potential benefits and costs of action or lack of action Be subject to review, in the light of new scientific data Be capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.
There is no single recipe for precaution, nor does precautionary action guarantee against mistakes. Using precautionary measures is a powerful tool for managing risks, but its application, without proper control can lead to negative unintended consequences. Within the regulatory process, it can, under certain circumstances, reduce transparency and erode the link between evidence of potential harm and government action. If misguided, this process might increase administrative discretion and can undermine legitimacy. It may also reduce the effectiveness of regulatory decisions, and hence damage public trust.
2.5 Science and Policy Central to the Framework is the careful, ethical use of available scientific evidence. This Framework extends rather than replaces the notion of science-based risk management, in that it recognizes the overarching nature of the considerations and tools that are necessary for dealing with uncertainty.
Conventional scientific methods distinguish “established” from “uncertain” effects and take action mainly on the former by developing standards that limit exposure. A high level of proof is required to establish a risk, which tends to generate false negatives (i.e. assuming that a risk does not exist when it actually does). By contrast, society as a whole is often more ready to accept a
8 false positive (i.e. assuming that a risk does exist when actually it does not), because they do not want a potentially real risk overlooked. The conflicting ethical value systems underlying such discrepancy have been described in the literature (for example, Comba et al., 2004).
It is important to recognize that there are different types of uncertainty - Insufficient data (gaps in knowledge which can be filled by targeted research) - Uncertainty within data (experimental and statistical ambiguities and biases) - Ignorance (areas of potential risk, which are not on the radar screen, also called "unknown unknowns").
The extent of knowledge and uncertainty varies from effects for which there is some evidence but considerable uncertainty to effects regarded as “established” by conventional scientific criteria. The role of science is not confined only to determining “established” effects, but also to identifying gaps in knowledge and uncertainties. In this case science provides a basis for the degree of precaution that could be taken.
The strength of scientific evidence concerning a potential risk is one of the factors considered in selecting appropriate actions. Other factors include technical feasibility, economic costs and benefits, and political realities. This Framework also recognizes that perspectives based on social and cultural factors, ethical values, and experience or observation constitute the context that ultimately determines the policy decisions.
3. Applying the Framework
The basic steps of the Framework are shown in Figure 1, and are described in detail in this section. Consultation with relevant stakeholders should be sought at every step of the process.
3.1 Getting started Dealing with uncertainty is a challenging task, which is becoming increasingly required. Ideally, the goals of maximizing good health and protecting it from uncertain, potentially far-reaching hazards, must guide the process of decision making from the very beginning. An approach aimed at anticipating possible health problems, rather than mitigating any adverse impact, is preferable. There are questions that need to be addressed before using this Framework:
Is there a legislative framework that provides for the process to commence? Is there a mandate and an approval process for a particular department or agency to lead the process of developing policy or measures? If not this should be sought prior to commencing the process. Are there appropriate scientific experts and government or agency representatives to form a committee from which the process can evolve and be managed? Is there funding to complete the whole process?
9 Once the administrative basis has been established, a committee should be formed of responsible government agencies, scientists who can advise on the issue and other appropriate stakeholders. A strategy should then be developed for using the Framework to guide the committee's work.
3.2 Health issue in context Existing risk management frameworks deal mostly with established risks. This Framework expands the scope of uncertain risks to include those where the scientific evidence is weak or lacking. In this paradigm, social, political and health contexts are central.
Many societies have a heightened level of concern for vulnerable populations such as the infirm, the elderly and children because they may be unable to take actions to effectively manage their own risk. Furthermore, many societies believe that the child and the foetus should be afforded an even higher level of protection because of their increased vulnerability, greater potential for exposure over their lifetime and because they represent the future of the society.
From a political viewpoint, attention is often directed at inequities in the distribution and magnitude of actual and potential exposures (individual and total) and consequent adverse health outcomes. Often, the distribution of benefits and risks are uneven in time and across groups, and situations that could be viewed as inequitable need to be addressed.
From a health viewpoint, special attention is paid to ubiquitous exposures because even a relatively small (and thus difficult to detect) health risk to many individuals may have significant public health consequences. The nature of the presumed health effect is also a factor in putting the health issue in context. Some diseases, such as cancer, are particularly dreaded. Other maladies, such as headaches and sleeplessness, are not life threatening and are often treatable, but can nevertheless have a profound influence on an individual’s well being and productivity.
Also relevant is the level of risk deemed acceptable by the society concerned, which depends on its nature. For involuntary exposures some countries have adopted a notional value of risk of 1 in 100,000 as a general threshold (with 1 in a million as an ideal goal) below which the risk is considered to be acceptable or impractical to improve on. For risks undertaken voluntarily, such as smoking or rock climbing, higher levels of risk are often more acceptable. These considerations become particularly problematic when dealing with uncertain health impacts.
Putting the health issue in context or risk profiling may also need to recognize and evaluate factors that include: whether the consequence is likely to be immediate or delayed whether the consequences are reversible whether the effects are chronic, cumulative or catastrophic in nature the severity of the consequences whether or not the risk is well-characterized by science the size, nature or special characteristics of the group exposed to the risk the distribution of the risk across sub-groups
10 the effect on future generations whether the hazard is encountered occupationally
3.3 Risk assessment For traditional science-based risk assessment:
The overall evaluation is based on the weight-of-evidence. The science must be rigorous, with input provided by many specialized disciplines, and mainly based on publications in peer-reviewed journals.
Uncertainties in the assessment of risk should be identified and clearly stated. Uncertainties can exist at every level of risk assessment: the existence of a hazard, the magnitude of exposure, and the relationship of dose to disease incidence or severity.
Assumptions necessary for the assessment of risk should be identified and clearly stated. When evidence is limited science-based assumptions or extrapolations are often used; for example extrapolating effects at high exposures to possible effects at lower exposures.
This Framework follows the same scientific principles and also attempts to clarify what is not known in addition to what is uncertain. A description of where key scientific evidence (e.g. epidemiological or toxicological studies) is missing or inadequate is especially important. Also, the relevance and informativeness of available evidence with respect to real-life exposures needs to be carefully scrutinized. It is possible to mistake an abundance of data for a high degree of knowledge. Scientists and decision makers should recognize that failure to demonstrate an adverse health effect does not rule out the possible existence of one since the test system used may not have been sensitive enough to detect any effect2. Also, failure to demonstrate an adverse health effect in a limited timeframe does not rule out the possibility that there may be some consequence sometime in the future3.
3.4 Option generation As part of the anticipatory nature of the approach to dealing with uncertainty, it is important that efforts are made to carry out a thorough, rigorous analysis of the alternatives available to the decision making process. If such analysis is done at the initial stages of a potential problem, for example when a new technology is proposed, it is more likely that alternative courses of actions can be identified that preserve societal benefits while averting any potential health problem. If such win-win strategies can be identified and supported by all or most stakeholders, then a low
2 Animal systems that are designed to provide information for regulatory issues generally emphasize identifying hazards. In contrast, many published studies are both limited and uncertain with respect to their ability to describe how the incidence or severity of the effect caused by a hazard changes with different environmentally-relevant doses. This is because dose-response relationships are often inferred from doses that are very high and environmentally-irrelevant. For some hazards, laboratory animal studies cannot be conducted at the high doses necessary to detect an effect with confidence and still comply with ethical guidelines, or be technically feasible. 3 An inability to demonstrate the existence of an adverse health effect in epidemiological or laboratory studies is sometimes taken to show that a causal relationship to the agent of concern is unlikely. However, long latency (the time between the initial exposure and evidence of the effect) is characteristic of many diseases and will limit for many years our understanding of the potential for a new exposure to cause harm.
11 level of proof on the health effect is required. While this optimal situation is rarely achieved, there are examples of success stories that can be used as model. In fact, such analysis of alternatives, fully resonant with fundamental values in medicine and public health, should be seen as a central element of precautionary action.
This Framework encourages consideration of the full range of alternatives and options to respond to uncertain health risks, is not restricted to a specified statutory or guideline exposure level, and includes options involving individual choice such as behaviour modification, information and risk communication. Further options based on education, voluntary initiatives, and market incentives are also possible. Where efforts aimed at removing or reducing the exposure are not feasible, options to minimize the seriousness of the health outcome (e.g. increased medical surveillance) should be evaluated. Examples of options are given in the box below.
EXAMPLES OF POLICY OPTIONS
A decision to take no formal action may be an appropriate response in cases where the risk is considered very small or the evidence is very weak. Research is always an appropriate response to fill gaps in knowledge, help identify potential problems, and to allow for a better assessment of risk in the future. A formal monitoring process provides transparency in monitoring the results of research and measurement, and the decisions being made by standard-setters, regulators, and others. This provides an early warning measure. Consultation, communication and engagement programmes can be used to help people voice their concern, understand the issues, become involved in the process and make their own choices about what to do. Labelling can sometimes be used to alert people to the exposure level from a device or technology and allow people to choose lower exposure option. Methods designed to produce reductions in exposure or, in the extreme, banning the source of exposure altogether are options to be used when the degree of certainty of harm is high, when the costs of limitations or bans are low, or both. Reducing exposure might include, for example, industry codes of practice, or economic incentives. Technical options (mitigation) normally involve making engineering or other technical changes to reduce or avoid exposure Voluntary behavioural change may be chosen to avoid or reduce exposure, if easily achievable. Special measures may be appropriate for vulnerable populations or groups. Numeric standards are formal steps taken by government to limit both the occurrence and consequences of potentially risky events. These may be imposed with defined methods of showing compliance, or they may state the objectives to be achieved without being prescriptive.
12 3.5 Option assessment and selection Option assessment
Option assessment for known risks is based on scientific, economic and technical information. Priority is given to preventing the risks, wherever possible, not just controlling them (e.g. the polio eradication campaign). Option assessment for known risks can be undertaken according to a cost-benefit analysis because the benefits are know, or a cost effectiveness analysis (an economic method to identify the least costly way to achieve a particular exposure reduction or health protection goal). Further discussion on this type of economic analysis is provided in Appendix A.
Option assessment within this Framework extends the same principles to uncertain risks. The nature of the assessment will depend on the strength of evidence for a risk:
Where, for example, the International Agency for Research on Cancer (IARC) or a body with equivalent status classifies an agent as “possibly carcinogenic” or that there is a possibility of causing other diseases, the benefit-cost analysis can be reasonably quantitative and objective, similar to that for a known risk.
Where the classification is less than this (e.g. insufficient evidence, IARC Group 3), the option assessment will inevitably be less objective, less satisfactory and less supportable. In this case option assessment may be sensibly restricted to only those options with very low costs. However, no matter how low the apparent cost of an intervention, at least a rudimentary cost-benefit analysis should be undertaken to ensure that an apparently “low cost” option really is low cost yet effective in achieving its intended benefit.
As a guide, if there are low or no cost options that reduces exposure, they should be implemented as soon as possible. As the cost of the option being considered increases, an analysis of the cost- effectiveness needs to be considered. For example, in the EMF area, cost-effectiveness considerations suggest implementing exposure reduction measures for new facilities rather than applying them retroactively to facilities already constructed. Examples of such measures adopted for new rather than old facilities can be found on the California Department of Health home page at: http://www.dhs.ca.gov/ps/deodc/ehib/emf/general.html.
Option selection
The European Commission has provided guidance on the selection of precautionary measures in its report (EC, 2000). Such measures include: Proportional to the chosen level of protection: Risk can rarely be reduced to zero, but incomplete risk assessments may greatly reduce the range of options open to risk managers. A total ban may not be a proportional response to a potential risk in all cases. However, in certain cases, it is the sole possible response to a given risk. Non-discriminatory in their application: Comparable situations should not be treated differently, and that different situations should not be treated in the same way, unless there
13 are objective grounds for doing so. For example, measures for mobile phone base stations should not be treated differently from radio or television transmitters. Consistent with similar measures already taken: Measures should be of comparable scope and nature to those already taken in equivalent areas in which all scientific data are available. Based on an examination of the potential benefits and costs of action or lack of action: Comparing the overall cost to the Community of action and lack of action, in both the short and long term. This is not simply an economic cost-benefit analysis: its scope is much broader, and includes non-economic considerations, such as the efficacy of possible options and their acceptability to the public. In the conduct of such an examination, account should be taken of the general principle and the case law of the Court that the protection of health takes precedence over economic considerations. Subject to review, in the light of new scientific data: Measures should be periodically reviewed in the light of scientific progress, and amended as necessary.
Scientific evidence influences option selection: stronger evidence, particularly of a pervasive, severe or irreversible health effect, supports more intrusive actions. Evidence that does not meet conventional scientific criteria as proof of cause, particularly for a pervasive, severe or irreversible health effect, tends to support selection of less intrusive actions. At one extreme, selecting the action of banning an agent or activity may depend on whether or not an alternative is available. If so, the implications of the alternatives for potential health effects, costs and benefits must be evaluated. Where no alternative is available and reduction of exposure is not feasible, the evaluation needs to compare the benefits provided by the agent or activity with its potential detrimental effects. At the other extreme, taking no formal action is often assumed to be the most benign option. However, taking no formal action should also be evaluated employing a similar methodology, including any costs due to public opposition or increased anxiety, which itself is detrimental to mental and social well being.
The weight of political, environmental, social, economic and other factors will need to be made explicit when selecting actions on the basis of precaution. Transparency is key to the commitment and trust of stakeholders. Their active participation is necessary for successful implementation of any chosen action.
3.6 Action implementation In traditional risk management frameworks, implementation often involves statutory or regulatory requirements. In this Framework, the selected options may include voluntary as well as mandatory measures. While mandatory measures can be implemented in the traditional way, implementation of voluntary measures may require further resources to inform, explain and promote these new measures through appropriate communication strategies. A broader range of stakeholder involvement is required for implementation when the benefits of the action become less favourable and costs, financial or otherwise, become more burdensome.
14 3.7 Action evaluation Evaluation of actions developed for a known health risk generally concern compliance and enforcement. In this Framework, actions not requiring measurable compliance may be harder to evaluate relative to the objectives of exposure reduction, reduced scientific uncertainty or reduced public concern.
Action evaluation is not the final step in the risk management process within this Framework. Rather, the process is iterative and intended to be responsive to newly available information and to changing societal values. Actions should be subject to periodic monitoring and review to determine their effectiveness and relevance in the context of prevailing scientific uncertainty. As new information becomes available, the policy measures should be reconsidered.
4. Discussion
4.1 Quantitative limits and guidelines Guidelines setting quantitative limits on human exposures to environmental agents are normally introduced only on the basis of consistent, reproducible data, confirmed by different laboratories and clearly establishing the levels of exposure to physical, biological or chemical agents thought to be harmful to humans. In addition, exposure limits generally incorporate safety factors that allow for uncertainty in identified thresholds for established effects. Such approaches remain central to this Framework; guidelines should not be undermined by additional, arbitrary exposure reductions in the name of precaution, since this would devalue their scientific credibility.
For the example of EMF, exposure limits in international guidelines (ICNIRP) have been determined on the basis of known health effects, using scientific criteria established over many decades. The reasons for adoption of international standards by national authorities are given below. The limits provide protection from known effects and so exposures well above these limits are known to produce adverse health consequences Any new technology producing EMF exposures above international limits should not be allowed because the science has established that they may be unsafe Arbitrary reductions in the international limits will have increased compliance costs since manufacturers normally test their products against international standards, but not against others. National authorities will have to bear the increased compliance cost, or products in their country will be more expense to cover the compliance cost, for no known health benefit. National limits well below those in international standards could prevent highly beneficial technologies being introduced, for no known health benefit.
4.2 Public concern In real circumstances, the debate on whether precautionary action is warranted, and if so what action is appropriate, often takes place when a potential, unproven risk factor is causing public concern. However, as noted in the guiding principles for this Framework, public concern may be a trigger for implementing public health policies, though the priority is the protection of health.
15 This should be interpreted to mean that the precautionary options selected should use the criteria identified in section 3.5.
It should also be noted that there is mounting evidence to suggest that when precautionary measures are selected and implemented without due process, or in an arbitrary way merely to placate public concern, greater and not less public concern is generated.
4.3 Consultation strategies The emphasis on consultation acknowledges that the acceptability of risk is ultimately at least as much about political and societal values and judgements as it is about scientific information. A partnership approach between key stakeholders for all risk management stages needs to be developed because of the clear need to modify the traditional separation between the approaches used to assess risks and those used to reduce them. Many risk management failures can be traced to a failure to involve stakeholders in decision-making at the appropriate time. While public input may be difficult to achieve at every stage, it is recognized that without involving interested and affected parties in the evaluation of risks and interventions, decisions taken may lack credibility and acceptance.
Stakeholders will need to be consulted for their views on the assessment of particular risks and on the analysis of possible interventions to manage those risks. The public will, for example, expect to contribute to the formulation of criteria to determine what risks are ‘negligible’ or ‘acceptable’. Without establishing public trust and confidence (so essential to the credibility of recommendations arising from the methodology) it will be difficult to secure acceptance of measures finally adopted. While there will not always be consensus on such issues, the position taken should be transparent, evidence-based and able to withstand critical scrutiny.
There will need to be flexibility as to who is consulted, at what stage(s) and what type and level of consultation is appropriate. This will vary from risk to risk and from stakeholder to stakeholder.
4.4 Communication strategies Some societies or sections of society are reticent to adopt precautionary measures in case this is seen as an admission that the health risk is real. In part, this concern relates to public perception of the issue. This concern can be ameliorated, though not necessarily completely removed, by sensitive an appropriate communication.
The need for and content of a communication strategy should be considered at an early stage, particularly if assessment of a risk is to proceed beyond the preliminary analysis stage. These strategies may need to be reviewed and revised as the process continues. The International EMF Project has published a booklet entitled "Establishing a dialogue on risks from electromagnetic fields" that provides considerable information on how to better understand peoples concerns about risks and how to communicate in a way that will be most effective. For further information see: www.who.int/emf.
16 Appendix A: Technical considerations for cost-benefit and cost-effectiveness analysis
Assessment of costs Costs are not just financial but include other consequences as well. Costs can be broken into three components: initial cost (actual cost of implementing the intervention), ongoing costs (any recurring costs directly created by the intervention or required to keep the intervention in place), and consequential costs (costs created as a consequence of the intervention, for example if the intervention causes people to modify their behaviour in some way).
Assessment of benefits In option assessment, the putative benefit or effectiveness of an exposure reduction or other option to prevent or reduce the adverse health effect is evaluated. Outcomes need to be clearly reported, as different answers might be obtained if the outcome is defined as number of fatalities, as opposed to disease incidence, or years of life. Effectiveness can be measured in terms of disability-adjusted life years (DALYs) gained by the option4. National governments may choose to emphasize other measures of the outcome. In principle, it is necessary to evaluate the impact that an intervention might have on the pattern of exposures across the population. In practice, this is not possible, simply because full information is never available. However it is important to avoid assuming that the consequences can be adequately expressed in terms of a single number representing a reduced exposure. Assessment should include various effects relating to different aspects of exposure (risk offset), re-distribution of exposures among people or populations (risk transfer), or creation of new risks (risk transformation). Comparison of costs and benefits To permit comparison with costs, the value of a health benefit is expressed in monetary terms, derived either from an observation of how much money a society is prepared to spend, or from the effect of health on economic productiveness. Benefits need to be expressed in units that make clear whether it is per person affected, per member of some sub-group or the whole population.
The value a society places on the reduction of risk or disease arising from a particular agent, technology or intervention assumes the reduction would actually occur, i.e. there is a known risk. Where the risk is uncertain, it will be necessary to adjust this figure.
While some costs will arise only once, others are on going as, in general, are the benefits. The applied costs and benefits must therefore be discounted using an appropriate model.
There will always be uncertainties, in the assessment both of the costs and the benefits. All significant uncertainties should be explicitly recognized.
4 WHO World Health Report 2002, p.106
17 The cost-benefit or cost-effectiveness analysis should be performed at the level of a whole society. It will therefore encompass all costs regardless of who might bear them, be it industry, taxpayers or others. Costs always have consequences, not least through the established association between disposable income and health. On the other hand, actions often lead to unanticipated benefits. The proper application of the Framework should address those consequences.
Incorporation of social factors The utilitarian approach to cost-benefit or cost-effectiveness analysis would be to reduce exposure until the cost of the last reduction equals its benefit. However, the Framework stresses the importance of recognizing social factors whereby society may wish to err on the side of caution and incur greater costs, in excess of the expected benefit. This can be accomplished either by making the test for comparing costs and benefits “not grossly disproportionate” rather than “equal”, or at the earlier stage of deriving a value for the uncertainadverse health effect prevented.
18 Appendix B: Case study on ELF electric and magnetic fields
One of the environmental agents which falls within the purview of the present Framework is the case of exposure to extremely low frequency (ELF) fields from the generation, transmission or use of electricity. The International Agency for Research on Cancer (IARC) has classified ELF magnetic fields as an agent that is “possibly carcinogenic” to humans (classification 2B); such classification embodies in itself the uncertainty of the health risk to the population, and is therefore a good candidate for the application of the present Framework.
Health Issue in Context ELF encompasses power frequency electric and magnetic fields. The evidence that ELF causes cancer was evaluated by IARC in 2001. IARC classified magnetic fields as 2B, “possibly carcinogenic”, and electric fields as 3, “unclassifiable”. The 2B classification for magnetic fields was based on the evidence for childhood leukaemia. For other types of childhood cancer and for all adult cancers, the evidence as assessed by IARC would not have been sufficient to warrant a 2B classification.
Non-cancer endpoints have not been formally classified by any WHO-recognized body. WHO itself will classify them in 2004 and will also revisit the IARC classification. It is assumed here that childhood leukaemia will remain at 2B and that no other health outcome will warrant a 2B classification. Should this change, the following assessment will need revision.
Thus we have:
Childhood leukaemia and magnetic 2B carcinogen fields Under the Framework, warrants a thorough consideration of precautionary measures including detailed cost-effectiveness analyzes Other childhood cancers Evidence weaker than for 2B Adult cancers Other health outcomes Under the Framework, a presumption that the evidence (provisionally) would not be strong enough to justify precautionary Electric fields interventions with significant costs. Detailed cost- benefit analysis not required. Consideration limited to low-cost interventions, if any, and more rudimentary cost-effectiveness analysis
For the one health outcome warranting full cost-effectiveness analysis of possible precautionary measures, childhood leukaemia:
The disease affects children The disease is perceived with dread The exposure is largely involuntary
19 There is evidence that in some situations the exposure burden may fall disproportionately on lower socio-economic status groups
Under the Framework, all these factors argue for adopting greater rather than lesser protection.
The size of risk potentially involved, e.g. of the order 1 in 2000 lifetime risk for childhood leukaemia, is unlikely to be regarded as negligible by any society.
The exposures that are associated with childhood leukaemia in epidemiological studies come primarily from electricity, used by society, flowing either in transmission and distribution circuits owned by electricity companies, or in wiring within buildings such as homes and schools. Other contributions to exposure come from domestic appliances, mobile phones and electric transport systems.
Risks Evaluation For childhood leukaemia, the epidemiological evidence suggests a relative risk of approximately 2 applying to children living in homes where the long-term average field (24 hours or longer) over the general volume of the house (i.e., specifically, not close to domestic appliances) is 0.4 µT or more.
There is uncertainty in whether the epidemiological evidence reflects causality or not. This uncertainty stems partly from the likelihood that bias may be present in the effect estimate, where there is a possibility that confounding, misclassification and selection bias may be present. Uncertainty also arises from the absence of reliable supporting evidence from in vivo or in vitro experiments and consideration of mechanisms. All these uncertainties are already captured by the IARC 2B classification as “possibly carcinogenic”.
If magnetic fields are a cause of childhood leukaemia, the chief uncertainties in assessing the risk are: Uncertainty as to the relevant aspect or metric of exposure. Long-term time-weighted average exposure in the home has been used in epidemiology partly for pragmatic reasons and may be a marker for some other aspect of exposure. Uncertainty as to exposure-response relationship. If long-term average is indeed the correct metric, it is not known whether there is a threshold (at 0.4 µT or any other value) or a smooth function, and if a smooth function, what shape. Uncertainty as to the aetiologically relevant period and duration-response relationship
In view of these uncertainties, WHO recommends: a working assumption that measures that reduce any aspect of average exposure across the population would indeed reduce the risk if there is one (this is equivalent to ruling out concepts such as exposure “windows”; a measure that reduces some aspect of exposure can be assumed not to increase any risk, though it may not be as effective as hoped) a recognition that any specific measure that reduces exposure is unlikely to reduce precisely the relevant aspect of exposure. Under the Framework this extra uncertainty must be included in any cost-effectiveness analysis.
20 Options Generation Possible precautionary measures for ELF will vary from country to country. WHO suggests the following categories as a guide and an aid to further discussion but expects each country to modify this list as appropriate:
Do Nothing Take no formal action; maintain the status quo
Research Enhanced research to remove uncertainties in the science Further research on sources and distribution of exposure in different countries to allow more informed decision making
Communications Increased provision of information to the public, particularly information on sources of exposure and ways of reducing exposure by individual lifestyle choices, to make it easier for members of the public to adopt individual precautionary approaches if that is their choice
Engineering measures Enforcement of existing approved wiring practices in distribution systems and buildings to reduce magnetic fields (this possibility arises because a major source of magnetic fields is ground currents, and ground currents sometimes arise from incorrect wiring) Changes to distribution wiring practices to reduce ground currents (not all ground currents are accidental, many arise from the legitimate multiple grounding of neutral conductors which is a feature of wiring practices in many countries, but which could be changed) Other engineering changes to distribution or transmission systems (it is possible to reduce fields by raising ground clearances, split-phase designs, undergrounding, etc) Changes to design of domestic appliances to reduce magnetic fields
Planning measures Changes to planning procedures to reduce exposures from high-voltage overhead lines (this includes changes to procedures for assessing the need for and siting of new lines, and changes to planning regimes that affect homes and schools already situated or proposed near existing power lines)
Exposure limits WHO believes exposure limits should be based on effects conventionally regarded as established and are not an appropriate mechanism for implementing precautionary approaches. Therefore WHO does not recommend including exposure limits based on the childhood leukaemia data as an option.
Cost-based options A method of delivering reduced exposure may be to specify a certain sum of money or a certain percentage of the cost of a project to be spent on field reduction, subject only to a test that a certain level of field reduction is achieved by spending that money. This is
21 philosophically less attractive as the direct weighing of costs and benefits is lost, but may be practical in creating an onus to reduce exposures without constraining the method.
All options may need considering separately for retrospective and prospective application.
Option Assessment and Selection Under the Framework, national governments should perform cost-effectiveness analyzes of these possible measures and any others they may identify. Cost effectiveness analysis compares the effectiveness of a measure with alternative ways of achieving a similar benefit.
As detailed in the Framework, the cost-effectiveness analysis should incorporate: the uncertainty that magnetic fields actually cause childhood leukaemia the uncertainty as to the relevant aspect of exposure to reduce the greater store that societies will typically set on reducing the risk of a dreaded disease, affecting children, with involuntary exposure the full range of costs of each measure, including both financial and non-financial costs and any redistribution of the burden of exposure The incidence of childhood leukaemia in the country concerned and the fraction potentially attributable to magnetic fields the number of children a given measure would affect
An indication of the factors that will need considering for each option is given in the following table, but is not exhaustive.
Option Relevant factors in considering Relevant factors in considering costs benefits Do nothing No possibility of reducing burden of disease and no progress towards removal of uncertainties and better knowledge in future Research Ability to remove uncertainties and Opportunity cost of research into allow better decisions in future. other risk factors not carried out Removal of possibility (albeit currently low) that a high- prevalence disease may be caused by ELF with much higher public health burden than for childhood leukaemia Opportunity to discover other risk factors and thus reduce disease burden Communication May have limited effectiveness Possibility of creating undue alarm or where exposure is not easy to concern. Note: WHO accepts this understand or is involuntary and factor is in principle relevant, but hard to avoid considers it is often overstated Remove wiring errors May have safety benefits A significant part of the cost may be in identifying the instances
22 Changes to grounding Existing grounding practices have Expertise on costs rests largely within practices evolved partly for cost reasons but electricity utilities. Governments partly for safety reasons, should draw on this expertise but specifically, reducing injury due to should audit it suitably. Costs are electric shock. Any increased risk likely to vary greatly when comparing of actual harm from other reasons new installations with changes to such as shocks should be set against existing installations. the possible benefits from reducing magnetic fields Other engineering Reduction of exposures should be Ditto changes assessed for real electricity systems not idealised ones, e.g. with realistic levels of imbalance Changed appliance Of the various possible aspects and Increased cost (or increased size or design sources of exposure, domestic weight) of appliances is a factor. But appliances are less clearly linked to this may be offset if presented as a the measure implicated by consumer choice in combination with epidemiology, and therefore any suitable information benefit should be reduced appropriately to reflect this uncertainty Changed planning Might facilitate building of new Costs may include sterilization of regime facilities and thus save money land, devaluation of property, and compensation payments, but these are highly dependent on the existing regime in place in each country Specified sum of Clear and simple leading to As there is no direct comparison of money potentially greater take-up benefits with costs, runs the risk of money being spent disproportionate to any actual benefit
In accordance with the Framework, costs should be considered at the level of the society as a whole and all costs should be included, whether born by industry, taxpayers or others.
The following factors will apply to any such analysis: childhood leukaemia is a relatively rare disease taking the epidemiological evidence at face value, only a small fraction of the population is exposed at the levels associated with a significantly increased risk there are many uncertainties as to whether any intervention would be effective or not, including the uncertainty as to whether magnetic fields are causal or not and the uncertainty as to which aspect of exposure is the relevant one to reduce
In view of these factors, and even after fully allowing for the legitimate desire by society to err on the safe side, it seems likely that only very low-cost measures will be justified. Specifically:
23 exposure limits set at 0.4 µT or similar levels seem unlikely to be justifiable. WHO considers that exposure limits for EMF should continue to be based on science conventionally regarded as “established” any measures involving changes to engineering practice seem unlikely to be justifiable, unless they bring other benefits as well, such as greater safety, or unless local circumstances mean they of particularly low cost. it seems unlikely that a precautionary approach to EMF alone could justify a change to distribution grounding practices, but EMF should be considered alongside safety, reliability and economics when changes are contemplated appliance manufacturers should investigate whether magnetic fields could be reduced at low cost, and whether offering consumer choice of low-field appliances could be an advantageous marketing strategy enforcing existing wiring codes so as to reduce unintentional ground currents must be sensible, but high costs in proactively seeking out and identifying existing errors are unlikely to be justifiable the costs of changes to planning regimes for high-voltage power lines are dependent on national circumstances, and no generalization is possible. However, procedures may be adopted which require efficient reduction of exposure for each new project continued and enhanced research programmes are desirable to remove uncertainty in the future communication to the public allowing informed decision making seems eminently sensible and justifiable
For suggested health effects where the evidence is less than required for a “2B” classification, the Framework calls for a simpler assessment, including only low-cost options. These options would seem to be: research communications changes to grounding practises IF there are other reasons for such changes changes to appliance design IF this can be made a matter of consumer choice changes to planning regime for high-voltage power lines DEPENDING on the particular circumstances of each country
Action Selection and Implementation In the light of the analysis conducted of the various options, national governments or their agencies will select and implement appropriate options. The exact way this is done will be specific to the particular country. In general, for options selected for precautionary reasons, voluntary codes, encouragement and collaborative programmes rather than rigid enforcement will be appropriate.
The Framework calls for implementation of precautionary measures to be free from legal connotations, particularly since ELF has already seen litigation in several countries. Specifically, the chosen measures should be implemented in such a way that:
an individual or company acting to reduce exposures under the Framework is not taken to be admitting legal liability for such exposures
24 the decision to reduce an exposure is not taken as evidence that such an exposure is in fact dangerous
The Framework encourages involving a broad range of stakeholders. For ELF, stakeholders should include government, academics, citizen groups, other affected professionals such as planners, school officials and real estate professionals, and industry, including the electricity industry and appliance manufacturers.
Action Evaluation As detailed in the Framework, the actions chosen should be re-evaluated periodically, and in particular, when new scientific understandings emerge.
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