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/

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Center for Risk Science and Public Health
BSE Spread Hypothesis
RenderingFeed
BSE
Cattle
Scrapie?
Spontaneous?
Other?

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. 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. 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. 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. Center for Risk Science and Public Health
BSE Spread Hypothesis
RenderingFeed
BSE
Cattle
Scrapie?
Spontaneous?
Other?
Feed Ban

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. 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. 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. 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. 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. 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. 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. 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. 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. 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