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Human and Ecological Risk Assessment: An

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Quantitative Risk Assessment Breeds Fear

a

Iain F. H. Purchase & Paul Slovic

a

University of Manchester, Manchester

Decision Research, Eugene, Oregon

Published online: 09 Oct 2012.

To cite this article: Iain F. H. Purchase & Paul Slovic (1999) Quantitative Risk Assessment Breeds Fear, Human and Ecological
Risk Assessment: An International Journal, 5:3, 445-453
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Quantitative Risk Assessment Breeds Fear

Human and Ecological Risk Assessment: Vol. 5, No. 3, pp. 445-453 (1999)

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PERSPECTIVE:
Quantitative Risk Assessment Breeds Fear
Iain F. H. Purchase
University of Manchester, Manchester

Paul Slovic
Decision Research, Eugene, Oregon**

INTRODUCTION
The practice of quantitative risk assessment has steadily increased in prominence during the past several decades as government and industry officials
have sought to develop more effective ways to meet public demands for a safer
and healthier environment. Ironically, as society has expended great effort to
make life safer and healthier, many in the public have become more, rather
than less concerned about risk (Slovic, 1987). This is particularly true for
involuntary exposure to chemicals, which the public associates to a remarkable
extent with danger, cancer, and death. National surveys in the United States,
Canada, and France have found that about 70% of the public believe that If
a person is exposed to a chemical that can cause cancer, then that person will
probably get cancer some day (Kraus et al., 1992; Krewski et al., 1995). About
75% of the respondents in these surveys agreed that If even a tiny amount of
a cancer-producing substance were found in my tap water, I wouldnt drink it.
More than 50% agreed that there is no safe level of exposure to a cancercausing chemical. This concern that any exposure to a carcinogen, no matter

**

School of Biological Sciences, G704 Stopford Building, University of Manchester,

Oxford Road, Manchester M13 9PT; Tel/Fax: +44 1625 520325; E-mail:
ifhp@chadzombe.u-net.com
Decision Research, 1201 Oak Street, Eugene, Oregon 97401-3575; Tel: +1
541.485.2400; Fax +1 541.485.2403; E-mail: pslovic@oregon.uoregon.edu

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how small, is likely to cause cancer is linked to a desire to avoid chemicals and
reduce the risks of exposure to them at any cost. About 75% of the public
surveyed agreed that I try hard to avoid contact with chemicals and chemical
products in my daily life. About 62% agreed that It can never be too
expensive to reduce the risks from chemicals.
In recent years, these public attitudes have played a role in many controversies, such as dioxins in the environment, pesticide residues in food, chlorination byproducts in drinking water, and the inadvertent presence of benzene
in bottled water. We shall argue below that quantitative risk assessment, based
on no-threshold models of carcinogenesis, contributes to the publics extraordinary fear of chemicals.

HOW ARE CHEMICAL RISKS ASSESSED?

The classical paradigm for risk assessment separates the intrinsic properties
of the chemical (for example, flammability or toxicity)which is known as the
hazardfrom the risk associated with a given level of exposure expressed as
the likelihood that effects will occur or the severity of the effects. This paradigm may be used for all risks, such as those from transport, radiation, or
bridge failures. It is obviously important to make the risk assessment quantitative, if possible, so that risks can be compared and the effectiveness of intervention evaluated.
In considering the risks from exposure to chemicals, it might be assumed
that epidemiological studies on exposed humans would provide the most
useful information. That this is not usually so can be ascribed to the inability
to control or account for confounding factors, the difficulty of estimating
exposure accurately, the long duration of studies, and the inherent insensitivity of epidemiological studies for identifying and characterizing low-level risks.
Furthermore, epidemiological studies can only be completed after exposures
have occurred, so that new chemicals must be tested in animal studies to
define their toxic properties. For these reasons, risk assessment primarily uses
estimates of toxicity from laboratory studies to define the potential human
hazard and to assess risk as quantitatively as possible.
One method of chemical risk assessment using experimental data is to
determine the critical effect; that is, the most serious effect or that occurring
at the lowest dose, and to define the No Observed Adverse Effect Level
(NOAEL) for that effect. This level is considered to be a threshold below
which adverse effects cannot be observed. By dividing the NOAEL by safety
factors (SFsometimes referred to as uncertainty factors) selected to reflect
the expected interspecies and interindividual variability (usually of 10 10,
but larger if the circumstances require), a reference dose may be calculated.
This can be considered as a dose unlikely to cause harm in any individual or
a safe dose and is used to set standards or control exposure. The method
does not compute the risk quantitatively, but provides a pragmatic method of

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Quantitative Risk Assessment Breeds Fear

reducing exposure, and therefore risk, which has been and is used successfully
internationally.
In the case of some toxic agents, such as those that damage DNA, there may
be no threshold. To assess risks from these agents, methods have been developed that rely on mathematical extrapolation from the animal data to the
human exposure, which is often tens or hundreds of thousands times lower.
These methods are particularly used for chemical carcinogens because it has
been argued that carcinogenesis is a nonthreshold phenomenon. The major
problem with these methods is that the calculated value is affected as much by
the choice of the mathematical model as by the data derived from the experimental work that defined the toxic hazard.

ARE THERE THRESHOLDS IN CHEMICAL TOXICITY?

The contention that there are no thresholds in chemical carcinogenesis
cannot rely on observation. Low-frequency events, such as the development of
cancer at incidences of 1 in 1000 or less, are difficult to determine experimentally and the interpretation of the presence of thresholds from the only study
designed to identify cancer incidence at the 1% level has been controversial
(Littlefield et al., 1979; Purchase and Auton, 1995). Exclusion of the development of cancer at rates lower than this has not been possible experimentally
and hence the presence of thresholds is dependent on theoretical considerations. These include mathematical treatments of data and studies of mechanisms of toxicity.

A COMPARISON OF THE TWO PRINCIPAL METHODS USED IN RISK

ASSESSMENT
The conclusion of the NOAEL-SF method of risk assessment is that a certain
dose (or exposure) is considered acceptable on the basis of the use of appropriate safety or uncertainty factors and the NOAEL. For the nonthreshold
methods, including both stochastic and tolerance-distribution models (UK
COC, 1991), the output of the calculation may be expressed as the unit risk,
or the magnitude of the risk for each unit of exposure, implying a linear doseresponse relationship.
The regulatory paradigm for assessing carcinogenic risks using the linear
multistage equation (the model that has been preferred by the USA EPA)
specifies that lifetime risks of developing cancer in excess of 1 in 106 (commonly referred to as the de minimis risk) are to be considered for regulation.
(The low-dose extrapolation now proposed for carcinogen risk assessment by
the USA EPA uses a simpler linear extrapolation from the LED10 the dose
calculated as the 95% lower confidence interval of that producing an inci-

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dence of 10%. Use of this method produces estimates of risk that are similar
to the linear multistage method).
A comparison of the two methods of risk assessment demonstrates that the
level of exposure to a chemical carcinogen that is calculated to carry a de
minimis risk of 1 in 106 is the same as the NOAEL divided by a safety factor
of approximately 250,000 (Purchase and Auton, 1995).
The arguments summarized above explain that we could obtain the same
numerical standard of exposure for a risk of 1 in 106 (equivalent to a
standard set in drinking water for a carcinogen, for example) from a carcinogenicity experiment by using the linear multistage equation or by using a
NOAEL and a safety factor of approximately 250,000. The important difference between these two approaches now becomes clear. In the case of the
linear multistage equation, the risk is expressed in positive terms as an
estimated cancer incidence associated with the exposure. Thus, for example,
1 ppb of the chemical in water might produce a risk estimate of, say, one in
a million. In the NOAEL-SF method, we can talk about a safety factor of
approximately 250,000 being applied to the lowest level of exposure observed to produce an adverse effect.
It has been argued that the linear multistage model is a more accurate
description of the situation, but that is only true if all the assumptions
involved are correctsomething that cannot be demonstrated. For example,
repair mechanisms, which are so effective in defense against chemical insult,
may overcome the infrequent molecular events associated with carcinogenesis; many chemical carcinogens are now known to act independently of
direct interaction with genetic material, and there is no observational method
available to demonstrate that a stochastic effect, such as induction of cancer,
does occur at a level of one in a million. Moreover, the empirical method for
estimating the critical slope parameter in the equation (or potency of the
carcinogen) is constrained by the experimental design of the carcinogenicity
study and the assumption of a linear dose-response relationship with a zero
intercept (Hrudey and Krewski, 1995). As a result, the slope is highly correlated with the top dose tested. There is also a strong correlation between this
dose and the acute toxicity of the chemical, implying that the critical slope
parameter is dictated more by the acute toxicity of the chemical than by its
carcinogenic properties.

NONTHRESHOLD ASSESSMENTS LEAD TO HIGHER PERCEPTIONS

OF RISK
Use of a nonthreshold model to express risk in probabilistic terms leads
to higher perceived risk than does the safety-factor format. This is demonstrated in two studies in which we asked people to evaluate the risk expressed
in each format. In the first study we asked 138 student volunteers from the

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University of Oregon and 26 students and faculty in a course on chemical

risk assessment to respond to the following task:
The task was based on a risk assessment derived from a study in which mice
were exposed for a lifetime by gavage to various levels of benzene in water (see
Table 1). Using a multistage model to extrapolate the mouse cancer incidence
to human consumption of 1.5 l of bottled water daily for 70 years at a daily dose
of benzene equal to 0.0002 mg/kg/day is estimated to produce a cancer risk
between 2 and 20 cases per million people exposed (see notes on the calculation of risk at the end of the manuscript). The formats for the two chemicals,
X and Y, both were based on the same data from the same chemical.
A strong majority of respondents in both groups judged the risk expressed
as about 1 chance in 100,000 (Chemical Y) to be greater than the risk expressed in nonprobabilistic terms (Chemical X). Specifically, among college
students 91 (66%) judged the risk from Chemical Y as greater, only 15 (11%)
judged the risk from Chemical X as greater, and 32 (23%) judged both risks

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about equal. Among participants in the risk-assessment course, 16 (62%)

judged the risk as greater for Chemical Y (5 of these said it was very much
greater and 5 said moderately greater), only 2 (8%) judged the risk greater
from Chemical X and 8 (31%) judged both risks about equal.
In the second study, an almost identical question was posed to 100 members
of the British Toxicological Society. The results were similar to those in the
first study. The majority of toxicologists (58%) judged the risk of Chemical Y
to be greater than the risk for Chemical X; only 2% judged X to have higher
risk and 40% judged both risks to be almost equal. In a second question, 81%
judged the risks from exposure to Chemical X to be essentially zero but only
31% judged the risks from exposure to Chemical Y to be essentially zero. When
asked which format they thought was better for communicating the risks of
chemical carcinogens to the public, 69% chose the non-probabilistic format
used for Chemical X and 31% chose the probabilistic format used for Chemical Y.
These results suggest that expressing small risks from exposure to chemicals
in probabilistic terms may unduly alarm the public and inhibit effective regulation and policy making. In particular, an asymmetrical assessment and presentation of risks from carcinogens in comparison to other toxic risks, which
may be similar in magnitude, may distort policies aimed at controlling risks.
Given the difficulty of discriminating between the dose-response relationships
of different toxic endpoints at low doses, we believe that risk communication
and risk management would be better served by using the NOAEL-SF method
to assess risks from all types of chemical toxic hazards.

ACKNOWLEDGEMENT
Dr. Steve Hrudeys helpful comments on a draft of this paper are gratefully
acknowledged. Paul Slovics work on this paper was supported by Grant SBR
9709307 from the National Science Foundation.

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REFERENCES
Hrudey, S.E. and Krewski, D. 1995. Is there a safe level of exposure to a carcinogen?
Environ. Sci. Technol. 29, 370A375A.
Kraus, N., Malmfors, T., and Slovic, P. 1992. Intuitive toxicology: Expert and lay
judgments of chemical risks. Risk Analysis, 12, 215232.
Krewski, D., Slovic, P., Bartlett, S., Flynn, J. and Mertz CK. 1995. Health risk perception
in Canada II: Worldviews, attitudes and opinions. Human and Ecological Risk Assessment, 1, 231248.
Littlefield, N.A., Farmer, J.H., Taylor, P.W., and Sheldon, W.E. 1979. Effects of dose
and time in a long term, low dose carcinogenicity study. J. Environ. Pathol. Toxicol.
3, 1734.
Purchase, I.F.H. and Auton, T. 1995. Thresholds in chemical carcinogenesis. Regulatory
Toxicology and Pharmacology, 22, 199205.
Slovic, P. 1987. Perception of risk. Science, 236, 280-285.
UK COC (UK Committee on Carcinogenicity of Chemicals in Food, Consumer Products, and the Environment). Guidelines for the evaluation of chemicals for carcinogenicity.
Report on Health and Social Subjects 42. (H. M. S. O., London, 1991).

APPENDIX
NOTES ON CALCULATION OF RISK: NON-THRESHOLD RISK
ASSESSMENT
The general formula used for low-dose extrapolation using the multistage
equation is:

[(

p = 1 exp q 0 + q 1d + q 2d 2 + L + q nd n

)]

Where p is the probability, and q1 is the calculated factor at a particular dose

(dn), q0, q1, q2 are model parameters for background incidence, linear risk,
quadratic risk, and so on. At low doses the terms d2, d3, and so on become very
small, hence the risk is dominated by q1. Hence q1 is used as an index of
potency. For the purposes of risk assessment of carcinogens, the USEPA uses
the 95% upper confidence limit of q1, denoted q1*.
The value of q1* derived for benzene in the mouse is 0.00811.
Using a simple equivalence of dose between mouse and human allows the
calculation of risk of ingesting benzene at a dose of 0.0002 mg/kg/day as
follows:
Risk = q *1 dose = 0.00811 0.0002 = 1.62 10 6

that is, approximately 2 per 106.

The value of q1* for humans based on surface area scaling is calculated as
follows:

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q *1 human, surface area =

( )
(BWm) (BWh)
(BWh) (BWm)
q *1 mouse

2/3

where BWm = mouse body weight = 0.04 kg, and BWh = human body
weight = 70 kg.

q *1 human, surface area =

0.00811
= 0.0977
0.0830

thus the calculated risk of ingesting benzene at a dose of 0.0002 mg/kg/

day = 0.002 0.0977 = 19.4 106, that is, approximately 20 per 106.

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