Risk Assessment as a Risk Management Tool

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Risk Assessment as a Risk Management Tool

• Bernard D. Goldstein, MD
• University of Pittsburgh
• Graduate School of Public Health

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Objectives of this Lecture

• The student will
• better understand the tools available to risk
  managers, particularly the role of risk
  assessment
• better understand the determinants of
  environmental policy
• become knowledgeable about the roles of the
  various governmental and non-governmental
  organizations involved in managing environmental
  risk

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The Three Approaches to Achieving A Policy Goal

• Reward
• Punish
• Educate

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What Are the Components of Risk Assessment?

• Hazard identification
• Dose-response evaluation
• Human exposure evaluation
• Risk characterization

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Uses of Risk Assessment for
Management Decision Making

• Federal (US and others) Regulations
• Environmental standards (air, water, hazardous
  waste, etc.)
• Food safety (chemical contaminants, additives,
  pathogens)
• Manufacturing and production (pharmaceuticals,
  pesticides, etc.)
• International Trade / WTO SPS Agreement
• Food products (Safety Assessment and Acceptable
  Daily Intake ADI)
• Animals and animal products
• Plants and plant products

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Risk Management

• Selection of an appropriate course of
• action using
• Risk assessment
• Statutory and legal requirements
• Economic effects
• Social considerations
• Informed judgments

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Driving Forces in Risk Management

• Politics
• Press
• Public Perception
• Bureaucratic Imperatives
• Law
• Economics
• Science
• Ethics

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Alphabet Soup

• State or local environmental/health agencies
• Non-Governmental organizations (NGO)
• Federal agencies
• Environmental Protection Agency (EPA)
• Interior, Agriculture, CPSC
• Health and Human Services (HHS)
• Food and Drug Administration (FDA)
• Natl Institute for Environmental Hlth Sci (NIEHS)
• Centers for Disease Control (CDC)
• Center for Environmental Health (CEH)
• Agy for Toxic Substances and Disease Registry
  (ATSDR)
• Natl Institute Occup Safety and Health (NIOSH)

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Reasons to Protect Ecosystems

1. Protect human health through maintaining the
   purity of the food and water supply
2. Protect species related to human activities
3. Protect the planet
4. It is the right thing to do ethically and morally

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No one would rather hunt woodcock in October than
I, but since learning of the sky dance I find
myself calling one or two birds enough. I must
be sure that, come April, there be no dearth of
dancers in the sunset sky.

Aldo Leopold A Sand Country Almanac, 1966
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Competing Goals in Managing Access to Americas
Natural Assets

• Maximize access so that all Americans can
  appreciate and obtain personal benefit from the
  beauties of our natural heritage
• Minimize access so as to preserve for future
  generations the pristine nature of our natural
  heritage

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When I grow up, I want to be a business mogul,
live in a villa in the suburbs, wear a suit by
Pierre Cardin, and drive a Mercedes-Benz 600 to
work in Beijing.
Chinese 5th Grader, quoted in World Press Review,
November, 1997
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• FORTUNATE GENERATION
• BORN AFTER THE
• ADVENT OF ANTIBIOTICS,
• GONE BEFORE
• THE OIL RUNS OUT

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Definition of Sustainable Development

• to meet the needs of the present without
  compromising the ability of future generations to
  meet their own needs.
• The World Commission on Environment and
  Development (The Brundtland Commission), Our
  Commission Future (Oxford Oxford University
  Press, 1987), p. 43

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Decision-Making Cultures, Nature Myths, and
Response Strategies
SUSTAINABLE DEVELOPMENT
PREVENTIVE
ADAPTIVE

• Nature is robust
• Morally wrong to curtail development

• Nature is robust within limits
• Morally imperative to preserve choice

• Nature is fragile
• Morally wrong to abuse nature

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Risk Management Example Pesticide X

• Exposure assessment
• Chemical is rapidly destroyed by sunlight
• Production process is totally enclosed
• Minimal residues remain on food
• Extensive skin contact during mixing and
  application

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So What Do We Do About It?

• FIFRA mandate is to control
• Unreasonable Adverse Effect
• . . . taking into account the economic, social,
  and environmental costs and benefits.

FIFRA Sec. 3 (c) (5) (c)
FIFRA Sec. 2 (bb)
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Other Statutes

• SDWA calls for establishment of maximum
  contaminant levels
• at which no known or anticipated adverse
  effects occur and which allow an adequate
  margin of safety.

SDWA Sec. 1412 (b) 1 (B)
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Non Risk Analysis

• Crop yields not significantly affected
• Minimal increase in pesticide production costs
• No substantial use of alternative, more toxic,
  pesticides

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Risk Management Decision

• Formulation Restriction
• Deny use as a liquid and permit use in granular
  form
• Application Restrictions
• Prohibit entry to field immediately following
  treatment
• Require interval between last treatment and
  harvest

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Pollution Control Standards

• Performance standards
• Emission standards
• Ambient Standards
• Environmental Indicators
• Health Standards

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Second Order Issues in Pesticide Use

• No till agriculture and pesticide/herbicide use
• Replacement of persistent agents by acutely toxic
  compounds
• Ecological impacts through altered land use
  patterns

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Legal vs Public Health Approaches to Anticipating
Risk

• Legal Approach to Anticipating Risk
• Assume complete compliance
• Hold sinners responsible
• Public Health Approach to Anticipating Risk
• Assume incomplete compliance
• Hold public health officials responsible

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Alternatives to Command and Control

• Common Sense Initiative
• Project Excel
• Environmental Indicators
• Education

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The Banning of Chlorine

• Criteria derived from the attempted
• ban on asbestos
• Is there a reasonable similarity in the potential
  for adverse consequences of all of the members of
  the chemical class?
• Are there replacements available for the societal
  benefits, including value to human and ecological
  health, provided by this class of compounds?
• Are we reasonably certain that the replacement
  compounds or activities are not more harmful than
  a focused approach to the problem.

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Environmental Justice Indisputable Facts

• There are more environmental hazards in
  disadvantaged communities
• There are more individuals with poor health in
  disadvantaged communities
• Individuals with poor health tend to be more
  susceptible to environmental pollutants

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Environmental JusticeKey Factors

• Problem is real but extent is unknown
• Need for better indicators of environmental
  health
• Local context must be understood
• Citizen involvement is central to resolution
• Jobs and the environment, not jobs vs the
  environment.
• Restoration of Brownfields

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Seven Ploys to Manage Inconvenient Scientific
Findings

1. Ask for more research
2. Ask for more review
3. Obfuscate
4. Control the communication of science
5. Set the wrong target
6. Set up a strawperson
7. Attack the integrity of the scientist

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Framework is Conducted

• In collaboration with stakeholders.
• Using iterations if new information is developed
  that changes the need for or nature of risk
  management.

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Framework for Risk Management

• Define the problems and put it into context.
• Analyze the risks associated with the problem in
  context.
• Examine the options for addressing the risks.
• Make decisions about which options to implement.
• Take actions to implement the decisions.
• Conduct the evaluation of the actions results.

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• THE ONLY CERTAIN PREDICTION
• FOR THE NEXT DECADE IS THAT
• THERE WILL BE AT LEAST ONE
• MAJOR ENVIRONMENTAL
• PROBLEM THAT NO ONE
• NOW PREDICTS.