Scribd
Upload
34 views37 pages

Bernard D. Goldstein, MD: An Overview of Risk Assessment

This document provides an overview of risk assessment, outlining its four main components: hazard identification, dose-response evaluation, human exposure evaluation, and risk characterization. It discusses risk assessment as an interface between environmental science and public policy, noting both its strengths as a public policy tool but also limitations, such as how well it incorporates scientific uncertainty. The document emphasizes that risk assessment and risk management are separate but related processes, with risk assessment informing risk-based decisions and policies.

Uploaded by

pendex40
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
34 views37 pages

Bernard D. Goldstein, MD: An Overview of Risk Assessment

This document provides an overview of risk assessment, outlining its four main components: hazard identification, dose-response evaluation, human exposure evaluation, and risk characterization. It discusses risk assessment as an interface between environmental science and public policy, noting both its strengths as a public policy tool but also limitations, such as how well it incorporates scientific uncertainty. The document emphasizes that risk assessment and risk management are separate but related processes, with risk assessment informing risk-based decisions and policies.

Uploaded by

pendex40
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 37

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:
The definition of risk assessment and its four
components, including their scientific basis.
The basic issues in environmental policy that are
responsible for the genesis and use of risk assessment.
The key strengths and weaknesses of risk assessment as a
public policy tool
The role of risk assessment as an interface between
environmental science and public policy

What Are the Components


of Risk Assessment?
Hazard identification
Dose-response evaluation
Human exposure evaluation
Risk characterization

Better Things Through Chemistry


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

Scientists manipulate
formulae to match the
real world.
Policymakers manipulate
the real world to match
formulae.

Comparative Risk of Death

Research and
Data Collection
Risk
Assessment

Risk
Management

The Three Laws of Toxicology


The dose makes the poison
Chemicals have specific effects
Humans are animals

Hazard Identification
The determination of whether a
particular chemical or agent is or is
not causally linked to a particular
health effect.

IARC Overall Evaluation of


Carcinogenicity to Humans
1

Carcinogenic to Humans

2A

Probably Carcinogenic

2B

Possibly Carcinogenic

Not Classifiable

Probably Not Carcinogenic

Weight of Evidence

Dose Response Evaluation


The determination of the relation
between the magnitude of exposure
and the probability of occurrence
of the health effect in question.

Dose-Response Curve
Observable
Range

Response

Range of
Inference

Dose

Structure of DNA

Human Exposure Evaluation


How many people will be exposed?
Through which routes?
Who is exposed?
What is the magnitude, duration,
and timing of the exposure?

Continuum for the Emission of and Exposure to a


Contaminant and the Expression of a Health Effect
Source
Emission

Transport and
Transformation

Health Effect

Accumulation
in
Environment

Early
Expression of
Disease

Human
Contact
Exposure

Biologically
Effective Dose

Elimination
Accumulation
Transformation

P.J. Lioy, Env. Sci. & Tech. Submitted 1990

Potential Dose
to the Body

Internal Dose

Bioavailability

Risk Characterization
The description of the nature and
often the magnitude of the human
risk, including attendant
uncertainty.

Risk Assessment
Dose-Response
Assessment

Hazard
Identification

Risk
Characterization

Exposure
Assessment

Risk Assessment

Risk Management

DoseResponse
Assessment
Hazard
Identification
Exposure
Assessment

Risk
Characterization

Regulatory
Decision

Control
Options
Non-Risk
Analysis

The Three Laws of Toxicology


The dose makes the poison
Chemicals have specific effects
Humans are animals

Uses of Risk Assessment for


Management Decision Making
National 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

Range of Expert Judgment

X XX XX X

Range of Expert Judgment

X X

X X

Communication
of Science

In the presence of uncertainty, the


technique usually relied upon to ascertain
the current state of knowledge is:

CONSENSUS by SCIENTISTS
BALANCE by JOURNALISTS
CONFRONTATION by LAWYERS

CATNIP PRINCIPLE
Cheapest Available Technology
Not Involving Prosecution

Margin of Safety
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?

Problems and Limitations of


Risk Assessment
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.

Problems and Limitations of


Risk Assessment
(continued)
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.

Problems and Limitations of


Risk Assessment
(

continued)

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.

Problems and Limitations of


Risk Assessment
(continued)
7. Risk assessment is secondary
prevention rather than primary
prevention.

Risk Assessment and Risk


Management is a 3 Step Process
Science Policy producing Risk
Assessment Guidelines
Risk Assessment
Risk Management

Risk Assessment Guidelines:


Use and Intent

Provide consistency
Establish data quality objectives
Assure technical quality
Clarify scientific assumptions
Allow flexibility to be transparent
Provide public with Road Map

Precautionary Principle Described


in the Rio Declaration:
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
environmental degradation.

Definition of the Precautionary


Principle
(Cynical Version)
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

RISK ASSESSMENT AND THE


PRECAUTIONARY PRINCIPLE
Three different views
The Precautionary Principle is already
incorporated in Risk Assessment
The Precautionary Principle should be
incorporated into Risk Assessment
The Precautionary Principle and Risk Assessment
are completely antithetical

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

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy