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

• Protect human health through maintaining the
  purity of the food and water supply
• Protect species related to human activities
• Protect the planet
• 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

• Ask for more research
• Ask for more review
• Obfuscate
• Control the communication of science
• Set the wrong target
• Set up a strawperson
• 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.