Philip Morris
Science and Its Limits: the Regulator's Dilemma
Fields
- Author
- Weinberg, A.M.
- Area
- LOGUE,MAYADA/OFFICE
- Type
- PUBL, PUBLICATION, OTHER
- BIBL, BIBLIOGRAPHY
- Site
- N426
- Request
- Stmn/R1-072
- Named Organization
- Atomic Energy Commission
- Beirr III Comm
- Comm on Biol Effects of Ionizing R
- Congress
- Division of Biol + Medicine
- Epa, Environmental Protection Agency
- Harvard
- Inst for Energy Analysis
- Loughborough Univ of Technology
- Nas, Natl Academy of Sciences
- Natl Research Council
- Nuclear Regulatory Commission
- Oak Ridge Associated Univ
- Oak Ridge Natl Lab
- Royal Inst of Technology
- Science
- Univ of Chicago
- American Physical Society
- Beirr III Comm
- Named Person
- Adler, H.I.
- Ames, B.N.
- Anderson
- Brooks, H.
- Clark, W.
- Delaney
- Frias, Asy
- Handler, P.
- Hannerz, K.
- Haseman, J.K.
- Kelley, P.
- Kletz, T.A.
- Lewis, H.W.
- Lohnert, G.H.
- Price
- Radford, E.P.
- Rasmussen, N.C.
- Reutler, H.
- Rossi, H.H.
- Ruckelshaus, W.D.
- Totter, J.R.
- Weinberg, A.M.
- Westermark, T.
- Whittemore, A.
- Ames, B.N.
- Document File
- 2025545619/2025546382/Harvard University Office of
- Continuing Education Short Course Program Harvard School
- of Public Health
- Continuing Education Short Course Program Harvard School
- Litigation
- Stmn/Produced
- Author (Organization)
- Issues in Science + Technology
- Master ID
- 2025545673/6381
Related Documents:- 2025545673-6381 Risk Analysis in Occupational and Environmental Health 910904 - 910906
- 2025545684 Telephone Locations and Protocol
- 2025545689-5696 Risk Assessment for Carcinogens: A Comparison of Approaches of the Acgih and the Epa
- 2025545697 Hps Newsletter Interview with A Risk Expert
- 2025545713-5721 Risk / Benefit Analysis
- 2025545722-5725 Risk Management Commentary for Dr. D. Allan Bromley Assistant to the President for Science and Technology
- 2025545726-5729 Risk Assessment and Comparisons: An Introduction
- 2025545750-5792 Risk Assessment of Chemical Carcinogens: Is It Time for A Change?
- 2025545795-5799 Tools of Risk Analysis Applications of Epidemiology
- 2025545800-5810 Notice of Intended Changes - Benzene
- 2025545811-5822 Epidemiology in Risk Assessment for Regulatory Policy
- 2025545824-5850 Risk Analysis in Environmental and Occupational Health Use of Animal and Other Data As Predictors of Human Risk
- 2025545851-5871 Risk Analysis in Environmental and Occupational Health Uncertainties in Predicting Human Risks
- 2025545872-5881 How Do Cancer Risks Predicted From Animal Bioassays Compare with the Epidemiologic Evidence? the Case of Ethylene Dibromide
- 2025545882-5887 Use of Biological Assays in Short-Term Assessment of Inhaled Substances
- 2025545888
- 2025545889-5891 Risk Analysis in Environmental and Occupational Health Are Your Mushrooms Safe to Eat?
- 2025545892-5899 the Rat As An Experimental Animal
- 2025545901-5907 Non-Cancer Endpoints
- 2025545910-5939 Cancer Facts & Figures - 890000
- 2025545940-5941 Cancer Facts & Figures - 890000
- 2025545942-5944 Get - the - Lead - Out Guru Challenged A Decade-Old Scientific Argument Over the Effects of Low-Level Lead on Iq Turns Nasty Following Allegations of Misconduct
- 2025545945-5948
- 2025545949-5958 the Question of Thresholds for Radiation and Chemical Carcinogenesis
- 2025545959-5980 Are There Thresholds for Carcinogenesis? the Thorny Problem of Low-Level Exposure
- 2025545981-5990 Perspectives on Comparing Risks of Environmental Carcinogens
- 2025545991-5998 Acceptable Cancer Risks: Probabilities and Beyond
- 2025546000-6011 Ideas in Pathology Pivotal Role of Increased Cell Proliferation in Human Carcinogenesis
- 2025546012-6017 Cell Proliferation in Carcinogenesis
- 2025546019-6027 the Role of Expert Judgement in Risk Analysis
- 2025546029-6039 the Respiratory Tract As A Route of Exposure
- 2025546040-6045 the Respiratory Tract As A Portal of Entry for Toxic Particles
- 2025546047-6062 Limitations to the Use of Employee Exposure Data on Air Contaminants in Epidemiologic Studies
- 2025546063-6083 Benefit - Cost Analysis of Environmental Regulation: Case Studies of Hazardous Air Pollutants
- 2025546086-6089 Legislative and Regulatory Aspects of Risk
- 2025546090-6099 Connecticut's Dioxin Ambient Air Quality Standard
- 2025546100-6103
- 2025546105 Annals of Radiation Calamity on Meadow Street
- 2025546106 Caution Urged When Using Insect Repellents
- 2025546116 Volatile Organics and Inorganics Action Levels 900400
- 2025546134-6135 Summary of Radon Test Results of the Household Testing Program
- 2025546141-6145 Introduction to Discussion Sessions
- 2025546146-6149 Risk Assessment in Environmental and Occupational Health Risk of Alar (Daminozide)
- 2025546150-6160 Intolerable Risk: Pesticides in Our Children's Food
- 2025546161-6162 Pesticides, Risk, and Applesauce
- 2025546163-6168 Daminozide Special Review Technical Support Document - Preliminary Determination to Cancel the Food Uses of Daminozide
- 2025546169 Daminozide / Udmh
- 2025546170-6172 the Relative Risk of Daminozide (Alar / Kylar) Use
- 2025546173 Be Most Wary of Nature's Own Pesticides
- 2025546174-6175 A Movie Star Pares the Apple Industry
- 2025546176-6183 Summary of Toxicology Data on Daminozide and Udmh
- 2025546184-6194 Attachment I Graphs of Data From NCI / Ntp 83 Daminozide
- 2025546195-6196
- 2025546197-6202 Daminozide Special Review Technical Support Document - Preliminary Determination to Cancel the Food Uses of Daminozide
- 2025546203-6224 Regulatory Decision - Making Under Uncertainty: the Case of Alar
- 2025546226 Epa Moves to Reassess the Risk of Dioxin Urged on by the Scientific Community, Epa Is Developing A New Model for Estimating Dioxin's Risk
- 2025546227 US Government Orders New Look at Dioxin the Environmental Protection Agency Is Evaluating Data From the Past Decade That Suggest Dioxin's Toxicity May Be Overestimated. A Risk Assessment Model Based on Biological Mechanism Is Being Drawn Up.
- 2025546228-6235 Dioxin Toxicity: New Studies Prompt Debate, Regulatory Action New Data on Dioxin's Effect on Humans, A Clearer Picture of the Cellular Events It Precipitates, and New Animal Toxicity Studies May Provide Epa with A Firm Basis for Regulation
- 2025546236-6250 the Regulation of Gene Expression by 2,3,7, 8-Tetrachlorodibenzo-P-Dioxin
- 2025546251-6253 Dioxin Risks Revisited Armed with A New Understanding of How Dioxin Works on the Molecular Level, A Number of Scientists Are Challenging Epa to Change the Way It Does Risk Assessment
- 2025546255-6258 Lead Toxicity Case Study for Short Course on Risk Analysis in Occupational and Environmental Health 910904 - 910906
- 2025546259-6267 Lead
- 2025546268-6275 Lead in Bone: Implications for Toxicology During Pregnancy and Lactation
- 2025546276-6281 the Long-Term Effects of Exposure to Low Doses of Lead in Childhood An 11 - Year Follow-Up Report
- 2025546282-6285
- 2025546298-6321 Review 890000 Alice Hamilton Lecture Lead and Human Health:Background and Recent Findings
- 2025546323-6348 Traps and Errors in Risk Analysis
- 2025546349-6356 Health Risks the Perception of Reality and the Realty of Perception
- 2025546357-6362 Communicating Risk Under Title III of Sara: Strategies for Explaining Very Small Risks in A Community Context
- 2025546363-6368 Industrial Risk Perceptions
- 2025546369-6370 Too Many Rodent Carcinogens: Mitogenesis Increases Mutagenesis
- 2025546371-6373 Has Risk Assessment Become Too 'conservative'?
- 2025546374-6378 Health and Safety Risk Analyses: Information for Better Decisions
- 2025546379-6381 Telling Reporters About Risk Dealing with Reporters Needn't Be the Least Agreeable Part of the Job.
- Characteristic
- EXTR, EXTRA
- Date Loaded
- 24 May 1999
- UCSF Legacy ID
- wjp02a00
Document Images
HAZARDS: SCIENCE AND ITS LIMITS
probability of such occurrences is zero-or at least, where the prevention of
such mishaps relies on immutable laws of nature that can never fail rather
than on the less than reliable intervention of electromechanical devices?
Surprisingay, this approach to nuclear safety has come into prominence only
in the past five years. Kare Hannerz in Sweden and Herbert Reutler and
Gunter H, Lohnert in West Germany have proposed reactor systems whose
safety does not depend on active interventions, but rather on passive, inherent
characteli:,tics.16 Although one cannot say that the probability of mischance
has been reduced to zero, there is little doubt that the probabilities are several,
perhaps three, orders of magnitude lower than the probabilities of mischance
for existing reactors. To the extent that such proposed reactors embody the
principle of inherent safety, their adoption would avoid much of the dispute
over reactor safety, the limits on nuclear accident liability contained in the
Price-Andcrson Act, repetition of the Three Mile Island accident, and so
forth. In short, such a technological fix enables one largely to ignore the
uncertainties in any prediction of core-melt probabilities.
The idea of incorporating inherent or passive safety into the design of
chemical p,lants had been proposed by Trevor A. Kletz of the Loughborough
University,of Technology in 1974, shortly after the disaster at the Flixborough
cyclohexane plant, which killed 28 people." I suspect that one of the main
consequences of the Bhopal disaster will be the incorporation of inherent
safety features into new chemical plants; again, a way of finessing uncertainty
in predicting failure probabilities.
De minimis. A perfect technological fix, such as a totally safe reactor or a
crash-proof car, is usually not available, at least at an affordable cost. Some
low-level exposure to materials that are toxic at high levels is inevitable, even
though we can never accurately establish the risk of such exposure. One way
of dealing with this situation is to invoke the principle of de minimis. This
principle, as Howard I. Adler and I suggested several years ago, argues that for
insults that occur naturally and to which the biosphere has always been
exposed and presumably to which it has adapted, one should not worry about
any additional man-made exposure as long as the man-made exposure is
small compared to the natural exposure.t8 The basic idea is that the natural
level of a ubiquitous exposure (such as cosmic radiation), if it is deleterious,
cannot have been very deleterious because in spite of its ubiquity, humans
have survived. Moreover, we do not know and can never know what the
residual effect of that natural exposure really is. An additional exposure that is
small compared to natural background radiation should be acceptable; at the
very least, its deleterious effect, if any, cannot be determined.
Adler and I suggested that for radiation whose natural background is well
known, one imay choose a de minimis level as the standard deviation of the
natural background. This turns out to be around 20 percent of the mean
background, around 20 millirems per year; this value has been used as the
Environmelzial Protection Agency standard for exposure to the entire radio-
chemical fuel cycle.
Scientists know more about the natural incidence and biological effects
of radiation than they do about any other agent. It would be natural, therefore,
to use the standard established for radiation as a standard for other agents.
FALL 1985 69

One can argue that
an accident whose
occurrence requires
an exceedingly
unlikely sequence of
untoward ~e»ents may
also be regarded as
an act of G-i9d.
This approach has been used by chemist T. Westermark of the Royal Institute
of Technology in Stockholm. He has suggested that for naturally occurring
carcinogens such as arsenic, chromium, and beryllium, one may choose a de
minimis level to be, say, 10 percent of the natural background.19
Clearly, a dee minimis level will always be somewhat arbitrary. Neverthe-
less, it seems to me that unless such a level is established, we shall forever be
involved in fruitless arguments, the only beneficiaries of which will be the
toxic tort lawyers. Could the principle of de minimis be applied in litigation in
much the same way it may be applied to regulation-that is, if the exposure is
below de minimis, then the blame is intrinsically unprovable and cannot be
litigated? I would imagine that the legal de minimis may be set higher than the
regulatory de minimis; for example, the legal de minimis for radiation could
be the background (after all, the BEIR-III committee concedes there is no way
of knowing whether or not such levels are deleterious). The regulatory
de minimis could justifiably be lower, simply on grounds of erring on the side
of safety.
One approach may bc to concede that there is some level of exposure that
is beyond demonstrable effect. This defines a trans-scientific threshold. A
de minimis level could then be established at some fraction, say one-tenth, of
this beyond-demonstrable-effect level. For example, if we take 100 millirems
per year of radiation as the beyond-demonstrable-effect level for general
somatic effects (damaging somatic cells as opposed to germline cells), which is
the value according to the BEIR-III committee, a de minimis level could be set
at 10 millirems per year. Of course, such a procedure would evoke much
controversy as to what is the beyond-demonstrable-effect level or whether 10
is an ample safety factor. This example demonstrates, however, that at least in
the case of low-level radiation, a scientific committee has been able to agree on
a beyond-demonstrable-effect level. As for the safety factor of 10, this cannot
be adjudicated on scientific grounds. The most one can say is that tradition of-
ten supports a safety factor of 10-forexample, the old standard for public ex-
posure (500 millirems per year) was set at one-tenth of the tolerance level for
workers (5,000 millirems per year).
Can the principle of de minimis be applied to accidents? What I have in
mind is the notion that accidents that are sufficiently rare may be regarded
somehow in the same category as acts of God and be compensated accord-
ingly. We already recognize that natural disasters should be compensated by
the society as a whole. One can argue that an accident whose occurrence
requires an exceedingly unlikely sequence of untoward events may also be
regarded as an act of God. Thus, the Price-Anderson Act could be modified so
that, quite explicitly, accidents whose consequences exceeded a certain level,
and whose probability as estimated by probabilistic risk assessment would be
less than, say, I in I billion per year, would be treated as acts of God.
Compensation in excess of the amount stipulated in the revised act would be
the responsibility of Congress. The cutoff for either compensation or for
probabilities would be negotiable, and perhaps it would be revised every 10
years or so. One not entirely fanciful suggestion may be to set any probability
of the order of I in 10 million to I in 100 million per year to be a de minimis
cutoff, this being the frequency at which the earth may have been visited by
70 1SSUES IN SCIENCE AND TECHNOLOGY

HAZARCS: SCIENCE AND ITS LIMITS
the comel:arv asteroids that may have caused the extinction of species in past
geologic eras.
As in most such questions, identifying and characterizing the problem is
easier tha n solving it. That the dilemma of the regulator and the toxic tort
judge is rooted in science's inability to predict rare events cannot be denied.
Getting lthe regulator and the toxic tort judge off the horns of the dilemma is
far from easy, and my two suggestions-the technological fix and de
minimis--are offered tentatively and with diffidence.
Equaily obvious is the intrinsic social dimension of the issue. In an open,
litigious democracy such as ours, any regulation and any judicial decision can
be appealed, and if the courts offer no redress, Congress, in principle, can do
so. These legal mechanisms are ponderous, however. The result seems to me
to be a gradual slowing of our technological-social engine as we become more
and mom enmeshed in fruitless argument over unresolvable questions.
Wes',~ern society was debilitated once before by such fruitless tilting with
Don Quixotian windmills. I refer of course to the devastating campaign
against witches from the fourteenth century to the early seventeenth century.
As ecolog~s,t William Clark has put it so vividly, society took it for granted dur-
ing that period that death, disease, and crop failure could be caused by
witches.x' To avoid such catastrophes, one had to burn the witches responsible
for them--and consequently some million innocent people were burned.
Finally, in 1610, the Spanish inquisitor Alonzo Salazar y Frias realized there
was no demonstrated connection between catastrophe and witches. Although
he did not prohibit the burning of witches, he did prohibit use of torture to ex-
tract confessions. The burning of witches, and witch hunting generally,
declined precipitously.
I have recounted this story many times by now. Yet it still seems to me to
capture the essence of our dilemma: the connection between low-level insult
and bodily harm is probably as difficult to prove as the connection between
witches and failed crops. I regard it as an aberration that our society has
allowed this issue to emerge as a serious social concern, which in the modern
context is hardly less fatuous than were the witch hunts of the past. That dark
phase in western society died out only aft' er several centuries. I hope our open,
democratic society can regain its sense of proportion far sooner and can get on
with managing the many real problems we always will face rather than waste
its energies on essentially insoluble, and by comparison, intrinsically un-
important, problems. ®
NOTES:
I. This article was adapted from a paper delivered at a June 3-4, 1985. National Academy of
Engineering symposium on "Hazards: Technology and Fairness." A report on that symposium will
be published in book form by the National Academy Press.
2. William 1). Ruckelshaus. "Risk, Science, and Democracy," Issues in Science and Technology I
(Spring 1985): 19-38.
3. U.S. Nuclear Regulatory Commission, Reactor SafetyStudt: An Assessment ofAccident Risk in U.S.
Commercrat Nuclear Plants (WASH-1400. NUREG 75/014) (Washington, D.C., 1975).
FALL 1985 71

4. U.S. Nuclear Regulatory Commission, Risk .4ssessmenr RevieK Group Report to the U.S. Nuclear
Regulaton Commission (NUREG/CR-0400) (Washington, D.C.. September 1978), vi.
5. "Repon to the American Physical Society by the Study Group on Light Water Reactor Safety,"
Reciexs oJAfodern Physics 47 (Supplement 1) (Summer 1975).
6. National Research Council, The Effects on Populations of Exposure to Low Levels of loni=ing
Radiation: 1980 (BEIR-IlI), (Washington, D.C.: National Academy Press, 1980), 2.
7. National Research Council, The Effects on Populations ojExposure to Low Levels of lonizing
Radiation: 1980 (BEIR-1I1), iii.
8. National Research Council, The Effects on Populations of Exposure to Low Levels of loni:ing
Radiation (BEIR-II), (Washington, D.C.: National Academy Press, 1972), 2.
9. Bruce N. Ames, "Dietary Carcinogens and Anticarcinogens," Science 221 (Sept. 23, 1983): 1249,
1256-64.
10. John R. Totter, "Spontaneous Cancer and Its Possible Relationship to Oxygen Metabolism,"
Proceedings ojthe National Academy oJSciences 77 (April 1980): 1763-67.
11. Alvin M. Weinberg and John B. Storer, "On 'Ambiguous' Carcinogens and Their Regulation," Risk
Analysis 5 (June 1985): 151-55.
12. National Research Council, The Effects on Populations of Exposure to Low Levels oj lonizing
Radiation. 1980 (BE1R-1Il), 287-321.
13. Alice Whittemore, "Facts and Values in Risk Analysis for Environmental Toxicants," Risk Analysis
3 (March 1983): 23-33.
14. John Ben-David, "Emergence of National Traditions in the Sociology of Science: The United States
and Great Britain," Sociological Inquiry 48, nos. 3 and 4(1978): 209.
15. Trevor J. Pinch and Wiebe E. Bijker, "The Social Construction of Facts and Artefacts: Or How the
Sociology of Science and the Sociology of Technology Might Benefit Each Other," Social Studies of
Science 14 (1984): 401.
16. KAre Hannerz, Towards Intrinsicalfr Safe Light liater Reactors (ORAU/IEA-83-2(M) Rev.) (Oak
Ridge, Tenn.: Oak Ridge Associated Universities. Institute for Energy Analysis, June 1983): Herben
Reutler and Gtinter H. Lohnert, "The Modular High Temperature Reactor," Nuclear Technologr 62
(July 1983): 22-30.
17. Trevor A. kletz. Cheaper, Safer Plants or If ealth and Sqfett at Gi'ork: Notes on Inherenth
Safcr and
Simpler Plants (Rugby. England: The Institution of Chemical Engineers, 1984).
18. Howard 1. Adler and Alvin M. Weinberg. "An Approach to Setting Radiation Standards," Health
Ph, vstcs 34 (June 1978): 719-20.
19. T. Westermark, Persistent Genoroxic I;'¢ues An .9ttempt at a Risk Assessment (Stockholm: Royal
Institute of Technology, 1980).
20. William C. Clark, it'itches. Floods, and If onder Drugs: Historical Perspectives on Risk
Management
(RR-81-3) (Laxenburg, Austria: International Institute for Applied Systems Analysis, March 1981).
72 ISSUES IN SCIENCE AND TECHNOLOGY
