An Overview of Risk Assessment. Bernard D. Goldstein, MD University of Pittsburgh Graduate School of Public Health. An Overview of Risk Assessment Objectives of this Lecture. The student will have an understanding of:
Bernard D. Goldstein, MD
University of Pittsburgh
Graduate School of Public Health
5,000,000 known chemicals (1,000,000 in 1945)
70,000 chemicals in widespread use
1,500 new chemicals in use yearly
Annual bioassay capability about 500/year
Policymakers manipulate the real world to match formulae.
The determination of whether a particular chemical or agent is or is not causally linked to a particular health effect.
Carcinogenic to Humans
Probably Not Carcinogenic
Weight of Evidence
The determination of the relation between the magnitude of exposure and the probability of occurrence of the health effect in question.
Range of Inference
to the Body
P.J. Lioy, Env. Sci. & Tech. Submitted 1990
The description of the nature and often the magnitude of the human risk, including attendant uncertainty.
CONSENSUS by SCIENTISTS
BALANCE by JOURNALISTS
CONFRONTATION by LAWYERS
Cheapest Available Technology Not Involving Prosecution
Is it Risk Assessment or Risk Management?
Components of decision:
What is strength of positive data?
What is strength of negative data?
Is uncertainty qualitative or quantitative?
What is the clinical significance of risk?
1. The process by which policy and science are mixed together in a risk assessment is poorly understood.
2. Its ability to provide a “Bright Line” has been overstated by risk assessors and overused by regulators and lawmakers.
3. The data quality objective for the different goals and types of risk assessment is poorly understood.
4. There is often a substantial gap between the data quality objective of the decision maker and the degree of complexity of the assessment, with unnecessary analyses confusing and delaying response.
5. Risk assessment often obscures the substantial gap between the data needs for good public health decision making and the paucity of available data.
6. Risk characterization should be extended beyond a probabilistic statement of cancer risk to include considerations of other health and non-health endpoints.
7. Risk assessment is secondary prevention rather than primary prevention.
Nations shall use the precautionary approach
to protect the environment. Where there are
threats of serious or irreversible damage,
scientific uncertainty shall not be used to
postpone cost-effective measures to prevent
The Precautionary Principle is a nebulous doctrine developed by Europeans as a means to erect a trade barrier against any item that can be produced more efficiently elsewhere