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Precautionary principle pp

Precautionary principle in environmental health

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Precautionary principle pp

  1. 1. Ahmed-Refat AG Refat 4/11/2014
  2. 2. Risk perception The task of decision-makers in defining "acceptable" risk, as part of the risk assessment process is complicated because people may not only hold different views about the "acceptability" of a particular risk, but also perceive "different risks differently". AhmedRefat AG Refat 2
  3. 3. Risk perception Hence “Risk perception” is a critical element of risk assessment and treatment which is ignored at the decision-maker's threat! AhmedRefat AG Refat 3
  4. 4. Attributes of Risk Perception and Acceptance • Voluntarily- involuntarily • Natural – industrial • Familiar – exotic • Not dreaded-dread hazard • Knowable – unknowable • No alternatives - many alternatives • Chronic – catastrophic AhmedRefat AG Refat 4
  5. 5. Acceptable" risk • Even if risk experts could agree on a ranking of risks : "acceptable" from "unacceptable" risk • Society does not generally necessarily view "equal risks equally". AhmedRefat AG Refat 5
  6. 6. Acceptable" risk • The Perceptions of risks and associated benefits, the "fairness" associated with risks and benefits is an important element in risk acceptance. • Who bears the risk? Who obtains most of the benefit? How is this share of risk and benefit? Another important influence on "acceptability" is trust in the processes and institutional arrangements for management of risk . AhmedRefat AG Refat 6
  7. 7. Acceptable" risk • Hence what is an acceptable risk to one individual or group or to one society may be quite unacceptable to another individual or group or to another society. • It follows that risk assessment requires negotiation between the stakeholders to define an "acceptable" level of risk for each "risk situation". AhmedRefat AG Refat 7
  8. 8. Case Studies : Misoprostol Example (1) Misoprostol AhmedRefat AG Refat 8
  9. 9. Case Studies : Misoprostol • Misoprostol, a drug that prevents gastric ulcers. Misoprostol was developed in the early 1980s and first approved in some nations in 1985. • The FDA, however, did not approve Misoprostol until 1988. Even though the drug was already available in several dozen foreign countries, the FDA subjected Misoprostol to a nine-and-one- half-month review. AhmedRefat AG Refat 9
  10. 10. Case Studies : Misoprostol • At the time, between 10,000 and 20,000 people died of gastric ulcers per year. • Had Misoprostol been approved more rapidly, it could have saved as many as 8,000 to 15,000 lives. AhmedRefat AG Refat 10
  11. 11. Case Studies : Misoprostol • Thus, in seeking to prevent one risk—the risk of approving an unsafe drug—the FDA contributed to the risk of gastric ulcers by preventing the use of a potentially lifesaving drug. AhmedRefat AG Refat 11
  12. 12. Example (2) Asbestos • It is now well accepted that asbestos causes the potentially fatal diseases of mesothelioma, lung cancer and asbestosis. The time between exposure and effect is delayed in some cases by up to 30 years or more, making cause-effect links difficult to prove conclusively. AhmedRefat AG Refat 12
  13. 13. Example (2) Asbestos • There were however, clear signs from the 1930s of the harmful effects of asbestos and a North American insurance company back in 1917 had the commercial "wisdom" not to insure asbestos workers. AhmedRefat AG Refat 13
  14. 14. Example (2) Asbestos • Nevertheless, it took until the early 1980s before asbestos was banned for most uses in Australia. Authorities waited for strong epidemiological evidence before responding, rather than taking precautionary action following the much earlier, suspicious but not conclusive, evidence available as early as the 1930s. AhmedRefat AG Refat 14
  15. 15. Example (2) Asbestos • A consequence of the lack of precautionary action is that many people have died from asbestos-related disease, there have been large claims against corporations involved with asbestos mining and manufacture, and Australia has the highest rate of mesothelioma in the world. AhmedRefat AG Refat 15
  16. 16. Characteristic of environmental problems • 1- spatial dimension • 2-Time-lag • 3- Quantitative side of matters. • 4- Cumulative effect. • 5-Irreversibility AhmedRefat AG Refat 16
  17. 17. Characteristic of environmental problems 1- spatial dimension Environmental problems tend not to stop at national borders and pollution created in one country often causes problems far away AhmedRefat AG Refat 17
  18. 18. Characteristic of environmental problems 2-There often exists a time-lag between the human behaviour and the moment at which the problem caused by this behaviour becomes clear AhmedRefat AG Refat 18
  19. 19. Characteristic of environmental problems 3- the quantitative side of matters. The behaviour of one single person or factory might be harmless, but combined with behaviour of others the effects might be disastrous AhmedRefat AG Refat 19
  20. 20. Characteristic of environmental problems 4- the cumulative effect. In themselves, the introduction might be harmless, but together with other substances a toxic mix might be formed. AhmedRefat AG Refat 20
  21. 21. Characteristic of environmental problems 5- The irreversibility of some effects of human behaviour AhmedRefat AG Refat 21
  22. 22. Ethical Tool To Take A Risk Advocates need a decision-making and action tool with ethical power and scientific rigor. AhmedRefat AG Refat 22
  23. 23. Ethical Tool To Take A Risk The precautionary principle, AhmedRefat AG Refat 23
  24. 24. Ethical Tool To Take A Risk • The precautionary principle, has become a critical aspect of environmental agreements and environmental activism throughout the world. P.P offers the public and decision-makers a forceful, common-sense approach to environmental and public health problems. AhmedRefat AG Refat 24
  25. 25. Precautionary Principle Application Level 1: Impacts are potentially serious (unacceptable) or irreversible and uncertainty is high: a strict application of the principle is required, insisting on complete reversibility and putting a strong burden of proof6 on development proponents. AhmedRefat AG Refat 25
  26. 26. Precautionary Principle Application Level 2: • Impacts may be serious but potentially reversible and a reasonable amount of data is available to appreciate risk: large safety margins should be ensured in assessments and decisions and use of the best available technology should be strictly required, i.e., regardless of costs. AhmedRefat AG Refat 26
  27. 27. Precautionary Principle Application Level 3: • Impacts are considered largely acceptable (and/or potentially reversible) and reasonably good scientific and other information is available: lower safety margins are accepted. The best available technology is required only if economical. AhmedRefat AG Refat 27
  28. 28. Precautionary Principle Application Level 4: Potential losses are considered neither serious nor irreversible: decisions could be based on traditional cost-benefit analysis. AhmedRefat AG Refat 28
  29. 29. Sources of Uncertainty • Lack of understanding of important cause- effect relationships, lack of scientific theory to explain these (eg effects of chemicals on humans and other organisms, concentration of chemicals in food chains). AhmedRefat AG Refat 29
  30. 30. Sources of Uncertainty • - Models that do not correspond to reality because they are simplifications and/or because we lack understanding of processes (eg models of the flow of chemicals through an ecosystem and the impacts of those chemicals on ecosystem components). AhmedRefat AG Refat 30
  31. 31. Sources of Uncertainty • - Lack of evidence on where the boundaries should be set for assessment of hazards (eg How many factors may influence the hazard? What type of consequences may occur? Over what area and time span?). AhmedRefat AG Refat 31
  32. 32. Sources of Uncertainty • - Poor quality of available data because of sampling or measurement inadequacies, lack of replication, lack of time series data . AhmedRefat AG Refat 32
  33. 33. Sources of Uncertainty • - Data gaps, such as no measurements on baseline environmental conditions at a project site. AhmedRefat AG Refat 33
  34. 34. Sources of Uncertainty • - Toxicological data that have been extrapolated from animals to humans and from high dose short-term experiments to low dose longer term situations. AhmedRefat AG Refat 34
  35. 35. Sources of Uncertainty • - Natural variation in environmental parameters due to weather, climate change. AhmedRefat AG Refat 35
  36. 36. Sources of Uncertainty • - Necessary assumptions on which estimates are based and the sensitivity of the resulting estimates to changes in assumptions. AhmedRefat AG Refat 36
  37. 37. Sources of Uncertainty • - Novelty of the project in terms of technology, chemicals, or siting- lack of experience or historical data. AhmedRefat AG Refat 37
  38. 38. The precautionary principle • Where possible risks to the environment and public health have been identified, action should be taken instead of waiting for conclusive evidence of a causal relationship AhmedRefat AG Refat 38
  39. 39. The precautionary principle Precaution: “An action taken in advance to protect against possible danger or failure; a safeguard. Caution practised in advance. AhmedRefat AG Refat 39
  40. 40. Sir Austin Bradford Hill, 1965: • "All scientific work is incomplete - whether it be observational or experimental. • All scientific work is liable to be upset or modified by advancing knowledge. That does not confer upon us a freedom to ignore the knowledge we already have or postpone the action that it appears to demand at a given time. AhmedRefat AG Refat 40
  41. 41. Key Elements of the P Principle • 1. Taking anticipatory action to prevent harm in the face of scientific uncertainty. 2. Exploring alternatives, including the alternative of "no action." 3. Considering the full cost of environmental and health impacts over time. 4. Increasing public participation in decision making. 5. Shifting the responsibility for providing evidence to the proponents of an activity. AhmedRefat AG Refat 41
  42. 42. The precautionary principle • A set of agreed cost-effective measures and actions, including future courses of action, which ensures prudent foresight, reduces or avoids risk to the resources, the environment, and the people, to the extent possible, taking explicitly into account existing uncertainties and the potential consequences of being wrong3 AhmedRefat AG Refat 42
  43. 43. The precautionary principle • clear evidence of threats cannot always be obtained before damage occurs. It is often necessary to make decisions in the face of persistent uncertainty and ignorance • AhmedRefat AG Refat 43
  44. 44. The precautionary principle • The origin of the precautionary principle is generally traced to the concept of “principle of advance caring” - in German environmental law in the early 1970s.This principle states that environmental policy requires a cautionary approach and was introduced to provide a decision-making tool for environmental risk managers. • AhmedRefat AG Refat 44
  45. 45. The precautionary principle • PP adopted by other European countries such as Denmark, Sweden, and France, and was extended from environmental matters to also cover issues of public health.. AhmedRefat AG Refat 45
  46. 46. The precautionary principle • PP also began to be in international treaties and policy documents. The first of these was the 1982 UN World Charter for Nature, which stated that “Activities which are likely to pose a significant risk to nature shall be preceded by an exhaustive examination . . . and where potential adverse effects are not fully understood, the activities should not proceed. AhmedRefat AG Refat 46
  47. 47. The precautionary principle • One of the most important expressions of the precautionary principle internationally is the Rio Declaration from the 1992 UNcED- Agenda 21. AhmedRefat AG Refat 47
  48. 48. The precautionary principle • Rio 1992 declaration stated : • In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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. AhmedRefat AG Refat 48
  49. 49. Precautionary Principle Or Precautionary Approach !!!??? • Approach: “A way and means of reaching something. The method used in dealing with or accomplishing something” • Principle: “A basic truth, an assumption. A rule or standard, especially of good behaviour. A fixed or predetermined policy or mode of action” AhmedRefat AG Refat 49
  50. 50. Precautionary Principle Or Precautionary Approach !!!??? • The term “approach” more accepted because it implies more flexibility, admitting the possibility of adapting technology and measures to socio-economic conditions, consistent with the requirement for sustainability. On the contrary, the term “principle” has developed a negative undertone because it is usually given a radical interpretation and has led to the outright ban of technologies. AhmedRefat AG Refat 50
  51. 51. The precautionary principle • ‫االحترازية‬ ‫المقاربة‬ • • ‫مبدأ‬ ‫الحيطة‬ – ‫االحتراز‬ ‫مقاربة‬ • ‫مبدأ‬ ‫االحتراز‬ – ‫الحيطة‬ ‫مقاربة‬ • • ‫االحتراز‬ • ‫ادعي‬ ‫من‬ ‫على‬ ‫البينة‬ • ‫براءتك‬ ‫اثبت‬ AhmedRefat AG Refat 51
  52. 52. Principle 15: Rio Declaration, 1992 • "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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." AhmedRefat AG Refat 52
  53. 53. COMPONENTS OF PRECAUTION 1. Taking precautionary action before scientific certainty of cause and effect 2. Setting goals 3. Seeking out and evaluating alternatives 4. Shifting burdens of proof 5. Developing more democratic and thorough decision-making criteria and methods AhmedRefat AG Refat 53
  54. 54. METHODS OF PRECAUTION 1. Bans and phase-outs 2. Alternatives assessment 3. Health-based occupational exposure 4. Reverse onus chemical 5. Organic agriculture 6. Premarket or pre-activity testing requirements. AhmedRefat AG Refat 54
  55. 55. METHODS OF PRECAUTION • Bans and phase-outs. A ban or phase-out could be considered the strongest precautionary action. • Clean production and pollution prevention. Clean production involves changes to production systems or products that reduce pollution at the source . • AhmedRefat AG Refat 55
  56. 56. METHODS OF PRECAUTION • Alternatives assessment. including a no-action alternative • Health-based occupational exposure limits list of occupational exposure limits based on the lowest exposure level at which health effects have been seen. AhmedRefat AG Refat 56
  57. 57. METHODS OF PRECAUTION • Reverse onus chemical listing put forward to drive the development of information on chemicals and their effects ‫عبئ‬ ‫االثبات‬ - ‫لوم‬ In Denmark, one proposal would require a chemical to be considered the most toxic in its class if full information on its toxicity was not available • AhmedRefat AG Refat 57
  58. 58. METHODS OF PRECAUTION Organic agriculture. It is risk averse, based on the principle of avoiding substances / practices that might cause harm rather than waiting for proof of harm. Premarket or pre-activity testing requirements. The FDA requires that all new pharmaceuticals be tested for safety and efficacy before entering the market. This model could be applied to industrial chemicals and other activities. AhmedRefat AG Refat 58