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Center for Risk Science and Public Health
The Risk Management
Challenge
George Gray
Center for Risk Science and Public Hea...
Center for Risk Science and Public Health
Overview
•  What is risk management?
•  Different risk management principles
•  ...
Center for Risk Science and Public Health
What is Risk Management?
Process of making decisions about controlling health,
s...
Center for Risk Science and Public Health
What is Needed for Risk
Management?
Scientific and technical information
•  Size...
Center for Risk Science and Public Health
What is Needed for Risk
Management?
•  Principles to guide decision making proce...
Center for Risk Science and Public Health
What is Needed for Risk
Management?
Tools for risk management
•  Regulatory auth...
Center for Risk Science and Public Health
Overview
•  What is risk management?
•  Different risk management principles
•  ...
Center for Risk Science and Public Health
Health-Based Risk
Management
•  Stipulate level of protection that must be achie...
Center for Risk Science and Public Health
Health-Based Risk
Management
•  Pros
•  high level of health protection for all ...
Center for Risk Science and Public Health
Technology-Based Risk
Management
•  Require control technology for pollution red...
Center for Risk Science and Public Health
Technology-Based Risk
Management
•  Pros
•  straightforward to implement once te...
Center for Risk Science and Public Health
Benefit/Cost Risk
Management
•  Attempts to explicitly balance the level of risk...
Center for Risk Science and Public Health
Benefit/Cost Risk
Management
•  Pros
•  under ideal conditions finds optimal lev...
Center for Risk Science and Public Health
The Precautionary Principle
and Risk Management
"The precautionary principle app...
Center for Risk Science and Public Health
The Precautionary Principle
in Risk Management
Technology
Potential Hazard
Risk ...
Center for Risk Science and Public Health
Precautionary Principle
•  Pros
•  Act in absence of “complete” information
•  A...
Center for Risk Science and Public Health
Information-Based Risk
Management
•  Provide information to allow public to make...
Center for Risk Science and Public Health
Information-Based Risk
Management
•  Pros
•  allows citizens to make their own i...
Center for Risk Science and Public Health
Measures of a Good Decision
•  A decision which maximizes total social
welfare i...
Center for Risk Science and Public Health
Managing Risks - BSE
•  Imagine it is mid-2003
•  You have decisions to make abo...
Center for Risk Science and Public Health
What is BSE?
•  Bovine Spongiform Encephalopathy - commonly
known as mad cow dis...
Center for Risk Science and Public Health
Transmissible Spongiform
Encephalopathies
•  Humans
•  Kuru
•  Crutzfeldt-Jakob ...
Center for Risk Science and Public Health
Characteristics of TSEs
•  All cause fatal spongiform changes in the brain
•  Lo...
Center for Risk Science and Public Health
The Odd Infectious Agent
of TSEs
•  Very resistant to standard disinfection proc...
Center for Risk Science and Public Health
The UK Outbreak
•  BSE apparently originated in the UK
•  Identified in 1986
•  ...
Center for Risk Science and Public Health
BSE Spread Hypothesis
RenderingFeed
BSE
Cattle
Scrapie?
Spontaneous?
Other?
Center for Risk Science and Public Health
The Spread of BSE
Country Cumulative
Incidence
Country Cumulative
Incidence
Aust...
Center for Risk Science and Public Health
BSE and vCJD
•  BSE originally seen as animal health concern based on
experience...
Center for Risk Science and Public Health
vCJD Cases
Incidence of vCJD in the UK
0
5
10
15
20
25
30
1994
1995
1996
1997
19...
Center for Risk Science and Public Health
Managing BSE and vCJD
Risk
•  Spread in cattle
•  Prevent use of rendered cattle...
Center for Risk Science and Public Health
BSE Spread Hypothesis
RenderingFeed
BSE
Cattle
Scrapie?
Spontaneous?
Other?
Feed...
Center for Risk Science and Public Health
Managing BSE Risks
•  Implement feed ban?
•  Does source/risk of alternatives ma...
Center for Risk Science and Public Health
Managing BSE Risks
•  Specified Risk Material (SRM) Ban
•  Remove highest risk t...
Center for Risk Science and Public Health
Managing BSE Risks
•  Prohibit consumption of older animals
•  Studies suggest B...
Center for Risk Science and Public Health
Managing BSE Risk
•  Post-mortem test for BSE?
•  Remember, no BSE in US now
•  ...
Center for Risk Science and Public Health
Managing BSE Risks
•  Ban on blood donations?
•  Some TSEs may be spread through...
Center for Risk Science and Public Health
What Would You Do?
•  Feed Ban
•  SRM Ban
•  Over 30 Months
•  Post-mortem testi...
Center for Risk Science and Public Health
BSE/vCJD Risk
Management Actions
UK EU USA
BSE? Yes Yes No
(1986) (1990)
Feed Ba...
Center for Risk Science and Public Health
Summary
•  Stringency of management measures appears to be
roughly in line with ...
Center for Risk Science and Public Health
Perils of Precaution?
BBC Online: Saturday, 15 December, 2001, 05:30 GMT
U-turn ...
Center for Risk Science and Public Health
Conclusions
•  Risk management describes the series of tools for
controlling ris...
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The Risk Management Challenge, George Gray

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Presentation by Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 15, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/

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Transcript of "The Risk Management Challenge, George Gray"

  1. 1. Center for Risk Science and Public Health The Risk Management Challenge George Gray Center for Risk Science and Public Health Department of Environmental and Occupational Health Milken Institute School of Public Health
  2. 2. Center for Risk Science and Public Health Overview •  What is risk management? •  Different risk management principles •  Mad Cow Disease - A Risk Management Challenge •  Conclusions
  3. 3. Center for Risk Science and Public Health What is Risk Management? Process of making decisions about controlling health, safety and environmental risks •  Cleaning up hazardous waste sites •  Setting air or water quality standards •  Developing fire or building codes •  Ensuring safe use of pesticides •  Informing consumers about products •  etc.
  4. 4. Center for Risk Science and Public Health What is Needed for Risk Management? Scientific and technical information •  Size of risk •  Distribution of risk •  Sources of risk •  Control strategies •  Costs of controls •  etc.
  5. 5. Center for Risk Science and Public Health What is Needed for Risk Management? •  Principles to guide decision making process •  Who is to be protected? •  What is to be protected? •  What determines the appropriate level of protection? •  Which risks should be addressed? •  etc.
  6. 6. Center for Risk Science and Public Health What is Needed for Risk Management? Tools for risk management •  Regulatory authority •  Public attention •  Economic incentives •  Voluntary agreements •  etc.
  7. 7. Center for Risk Science and Public Health Overview •  What is risk management? •  Different risk management principles •  Coke Oven Emissions - A Risk Management Challenge •  Conclusions
  8. 8. Center for Risk Science and Public Health Health-Based Risk Management •  Stipulate level of protection that must be achieved without regard to technology, cost, or feasibility •  e.g. Clean Air Act National Ambient Air Quality Standards - set standards to provide “ample margin of safety” for even the most sensitive groups •  Zero risk even more stringent - don’t allow any source of risk •  e.g. Delaney Clause of Food, Drug and Cosmetic Act
  9. 9. Center for Risk Science and Public Health Health-Based Risk Management •  Pros •  high level of health protection for all citizens •  assurance of “safety” •  Cons •  ignores feasibility and cost •  ignores benefits •  potential substitution risks •  may require very stringent regulation to protect sensitive subpopulations •  often contentious and slow – EPA frequently sued to reevaluate NAAQSs
  10. 10. Center for Risk Science and Public Health Technology-Based Risk Management •  Require control technology for pollution reduction or treatment •  e.g. Clean Air Act Amendments hazardous air pollutants provisions require maximum achievable control technology •  Sometimes take account of feasibility or cost of technology •  e.g. Safe Drinking Water Act maximum contaminant levels (MCLs) for carcinogens set as low as “feasible with the use of the best technology, treatment techniques and other means which the EPA finds after examination for efficiency under field conditions....are available (taking cost into consideration)
  11. 11. Center for Risk Science and Public Health Technology-Based Risk Management •  Pros •  straightforward to implement once technology is defined •  often relatively rapid •  Cons •  defining “best” technology may be difficult •  technology may lead to too little pollution control or too much •  encourages “end of pipe” controls rather than pollution prevention •  “freeze” controls?
  12. 12. Center for Risk Science and Public Health Benefit/Cost Risk Management •  Attempts to explicitly balance the level of risk reduction with the cost of reducing the risk •  e.g. Federal Fungicide, Insecticide and Rodenticide Act (FIFRA) attempts to prevent “unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide” •  Principle advanced in Executive Orders 12866, 13563
  13. 13. Center for Risk Science and Public Health Benefit/Cost Risk Management •  Pros •  under ideal conditions finds optimal level of risk reduction •  should lead to efficient allocation of risk reduction resources - “save the most lives for the least money” •  Cons •  some health and environmental benefits (and costs) difficult to quantify •  other social considerations such as equity, size of affected population, etc. may be important too.
  14. 14. Center for Risk Science and Public Health The Precautionary Principle and Risk Management "The precautionary principle applies where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the EU". February 2, 2000 European Commission Communication on the Precautionary Principle
  15. 15. Center for Risk Science and Public Health The Precautionary Principle in Risk Management Technology Potential Hazard Risk Assessment Benefit/Cost Analysis Risk Management Precautionary Principle
  16. 16. Center for Risk Science and Public Health Precautionary Principle •  Pros •  Act in absence of “complete” information •  Act to protect future generations" •  Place “burden of proof” on risk generator •  Cons •  Foregone benefit (Lack of access to a potentially risky technology may have health cost e.g., HIV/AIDS drugs) •  Risk tradeoffs (Precautionary actions may increase other risks e.g., UK vCJD and tonsil surgery instruments)
  17. 17. Center for Risk Science and Public Health Information-Based Risk Management •  Provide information to allow public to make their own risk reduction decisions •  e.g. California’s Proposition 65 requires warning on any consumer product or food “known to the state to cause cancer or reproductive toxicity” •  May operate through public pressure as well •  e.g. Emergency Planning and Community Right-to-Know act requires manufacturing facilities to report emissions of chemicals on federally determined list of dangerous substances (the Toxics Release Inventory or TRI)
  18. 18. Center for Risk Science and Public Health Information-Based Risk Management •  Pros •  allows citizens to make their own informed benefit/cost decision (Prop 65) •  companies can use most efficient method to reduce emissions (TRI) •  Cons •  over warning may lead to indifference (Prop 65) •  still need to establish appropriate level of protection •  great variation in toxicity of listed chemicals means significant risk reduction not assured •  assumes value of reducing all listed chemicals is similar (TRI)
  19. 19. Center for Risk Science and Public Health Measures of a Good Decision •  A decision which maximizes total social welfare is a good decision... •  A decision arrived at by a fair process is a good decision...
  20. 20. Center for Risk Science and Public Health Managing Risks - BSE •  Imagine it is mid-2003 •  You have decisions to make about how the US responds to bovine spongiform encephalopathy (BSE or “mad cow disease” •  Potential risk to animals and public health
  21. 21. Center for Risk Science and Public Health What is BSE? •  Bovine Spongiform Encephalopathy - commonly known as mad cow disease •  A Transmissible Spongiform Encephalopathy (TSE) of cattle
  22. 22. Center for Risk Science and Public Health Transmissible Spongiform Encephalopathies •  Humans •  Kuru •  Crutzfeldt-Jakob Disease (CJD and nvCJD) •  Fatal Familial Insomnia, etc. •  Animals: •  BSE (cattle) •  Scrapie (sheep and goats)) •  Chronic Wasting Disease (CWD) (deer and elk) •  Transmissible Mink Encephalopathy (mink) •  Feline Spongiform Encephalopathy •  Zoo animals
  23. 23. Center for Risk Science and Public Health Characteristics of TSEs •  All cause fatal spongiform changes in the brain •  Long incubation period •  Pathogenesis poorly understood •  Infectivity often concentrated in CNS tissues •  Infective agent unknown, current hypotheses focus on prions
  24. 24. Center for Risk Science and Public Health The Odd Infectious Agent of TSEs •  Very resistant to standard disinfection procedures •  Heat •  Radiation •  Acids or bases •  Survive in tissues after death •  Not destroyed by refrigeration or freezing •  Postulated to be small proteinaceous infectious particles - prions
  25. 25. Center for Risk Science and Public Health The UK Outbreak •  BSE apparently originated in the UK •  Identified in 1986 •  Nearly 180,000 cases identified in the UK since that time Incidence of Confirmed BSE Cases in the UK 0 5000 10000 15000 20000 25000 30000 35000 40000 1986 1988 1990 1992 1994 1996 1998 2000 2002 Year Cases
  26. 26. Center for Risk Science and Public Health BSE Spread Hypothesis RenderingFeed BSE Cattle Scrapie? Spontaneous? Other?
  27. 27. Center for Risk Science and Public Health The Spread of BSE Country Cumulative Incidence Country Cumulative Incidence Austria 1 Italy 88 Belgium 114 Japan 9 Canada 2 Liechtenstein 2 Czech Republic 5 Luxembourg 2 Denmark 13 Netherlands 63 Finland 1 Poland 8 France 849 Portugal 823 Germany 273 Slovakia 12 Greece 1 Slovenia 3 Ireland 1303 Spain 343 Israel 1 Switzerland 448 As of mid-2003
  28. 28. Center for Risk Science and Public Health BSE and vCJD •  BSE originally seen as animal health concern based on experience with scrapie •  1995 new form of human TSE identified •  Only found in countries with BSE •  Molecular and biochemical links to BSE •  Different signs and symptoms than classical CJD •  Fatal illness striking young people (average age 28 versus 63 in classical CJD) •  No strong epidemiologic link •  (new) variant Crutzfeldt-Jakob disease (vCJD) •  vCJD now considered likely human form of BSE
  29. 29. Center for Risk Science and Public Health vCJD Cases Incidence of vCJD in the UK 0 5 10 15 20 25 30 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year Cases Through 07-05-2004 169 Total As of September 2010 http://www.cjd.ed.ac.uk/figures.htm
  30. 30. Center for Risk Science and Public Health Managing BSE and vCJD Risk •  Spread in cattle •  Prevent use of rendered cattle (or other ruminant) protein in cattle feed (feed ban) •  Remove most infectious tissues from rendered material (specified risk material ban) •  Human exposure •  Remove most infectious tissues from human food supply (specified risk material ban) •  Prohibit consumption of animals of advanced age (over 30 month scheme) •  Test at slaughter •  Blood transfusion restrictions or treatments to address hypothetical human to human transmission
  31. 31. Center for Risk Science and Public Health BSE Spread Hypothesis RenderingFeed BSE Cattle Scrapie? Spontaneous? Other? Feed Ban
  32. 32. Center for Risk Science and Public Health Managing BSE Risks •  Implement feed ban? •  Does source/risk of alternatives matter •  GM soybean meal? •  Amazon deforestation? Agriculture, Ecosystems & Environment 120: 467-469
  33. 33. Center for Risk Science and Public Health Managing BSE Risks •  Specified Risk Material (SRM) Ban •  Remove highest risk tissues from human food and from rendering process •  Would reduce risks of “leaky” feed ban •  Reduce human risk •  Significant costs to industry •  Disposal issues
  34. 34. Center for Risk Science and Public Health Managing BSE Risks •  Prohibit consumption of older animals •  Studies suggest BSE infectivity very low until animals about 3 years of age •  Reduce potential for human exposure •  Significant disposal issues
  35. 35. Center for Risk Science and Public Health Managing BSE Risk •  Post-mortem test for BSE? •  Remember, no BSE in US now •  Reassure consumers and trading partners •  5 kits approved in EU •  False positive tests virtually certain
  36. 36. Center for Risk Science and Public Health Managing BSE Risks •  Ban on blood donations? •  Some TSEs may be spread through blood (BSE has not shown infectivity in blood) •  vCJD shows infectivity in lymph nodes – blood risk theoretical •  Reduction in blood supply poses health risks •  Local effects (NYC loses 25% of blood supply – imports and donors)
  37. 37. Center for Risk Science and Public Health What Would You Do? •  Feed Ban •  SRM Ban •  Over 30 Months •  Post-mortem testing •  Blood donation deferral
  38. 38. Center for Risk Science and Public Health BSE/vCJD Risk Management Actions UK EU USA BSE? Yes Yes No (1986) (1990) Feed Ban? Yes Yes Yes (1988) (1994) (1997) SRM Ban? Yes Yes No (1989) (1997) 30 Month Rule? Yes No No (1996) Post Mortem Test? No Yes No (2000) Blood Donation Deferral? No No Yes (leukodepletion) (1999)
  39. 39. Center for Risk Science and Public Health Summary •  Stringency of management measures appears to be roughly in line with BSE risk •  UK - many cases, most stringent measures •  EU - fewer cases, stringent measures •  US - no cases, serious measures but less than UK or EU •  Some question about proportionality of US blood donor deferral although similar to Canada and Australia
  40. 40. Center for Risk Science and Public Health Perils of Precaution? BBC Online: Saturday, 15 December, 2001, 05:30 GMT U-turn over tonsil operations The government has been forced to make a u-turn on the use of re-usable surgical instruments for tonsil and adenoids surgery. They had originally been withdrawn in January because doctors feared there was a theoretical risk of transmission of variant Creutzfeldt-Jacob Disease (vCJD) from re- usable surgical instruments. However, following the change surgeons, found more patients than before were being harmed during surgery. There was even one death linked linked to single-use instruments……... http://news.bbc.co.uk/hi/english/health/newsid_1692000/1692056.stm
  41. 41. Center for Risk Science and Public Health Conclusions •  Risk management describes the series of tools for controlling risks to human health and the environment •  Must be based on scientific risk information •  identify size of risk •  identify opportunity for risk reduction •  quantify competing risks •  Principles to guide management are necessary •  how to make decisions (efficiency or process) •  often mix of two •  Sometimes risk is only a small part of a risk management decision
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