Risk Science, Analysis & Management
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The study of Risk Science and the creation of a dozen or so Risk-related think-tanks, together with quite a few university courses carrying "Risk Analysis' or 'Risk Assessment' labels -- all emerged from the background of health and environmental concerns in the late 1970s and early 1980s. They promoted the idea that risk could be measured, calculated, extrapolated and predicted -- and then effectively managed -- by scientific methods. It was an ideology of regulatory control fostered by large corporations (especially the chemical, pharmacuetical and tobacco industries) as a way of putting a scientific gloss on their lobbying against limits and restrictions based on health and environmental issues.
| RISK SCIENCE ENTRIES |
|---|
| Risk Science, Analysis & Management |
| Risk Assessment History/tobacco |
| Risk Assessment & Management Commission |
| Task Force on Regulatory Relief (WhiteHouse) |
| Delaney Clause (Food, Drug Act) |
| RISK ORGANISATIONS |
| ILSI Risk Science Institute |
| Society for Risk Analysis |
| Harvard Center for Risk Analysis (HCRA) |
| Harvard Group on Risk Management Reform (HGRMR) |
| Resources for the Future |
| Coalition for Uniform Risk Estimation (CURE) |
| Institute for Regulatory Policy (IRP) |
It is important to distinguish (lower case) risk assessment from (upper case) Risk Assessment. The lower-case forms of assessment, analysis and management are all intended outcomes of the scientific disciplines of toxicology, epidemiology, biostatistics, and various environmental studies. Each of these studies uses totally different techniques on totally different data -- which is why the determinations of one can conflict with those of the others. When there is conflict, final decisions are made by politicians, bureaucrats or standards organisations which allocate different 'weightings' to different aspects of the evidence, and then balance their collective perception of the risk against the cost of imposing stronger regulations. These are never zero sum games.
The (Upper Case) Risk Science hierarchy of Risk Assessment, Risk Analysis, and Risk Management is an attempt to impose on this process a new so-called umbrella' scientific discipline which Harvard's Center called Decision Science. It is implied or stated that expertise in this Decision Science can discount the subjectivity of normal risk evaluation, and produce an objective determination that provides certainty to the regulators, legislators and standards organisations.
When they could see the way the wind was blowing -- especially after Harvard got into the act -- many of the old professional consultant in toxicology, epidemiology and microbiology overnight became consultants in Risk Analysis and Risk Management.
- [Risk Assessment and Risk Analysis are not always interchangeable terms. The term "Risk Assessment", as used by the EPA in the mid 1970s was opposed by the poisoning and polluting companies because it sought to 'characterise' and categorise the hazards. While "Risk Analysis", as promoted by the Harvard Center of Risk Analysis, sought to place economists and 'Decision Scientists' in the box-seat of regulation by adding cost-benefit calculations (with many untestable assumptions) to the burden of the work on the regulatory agencies]
To Lighten the Regulatory Burden
The aim of Risk Science was specifically to influence political judgements and lighten the regulatory burden on the corporations. However, the idea was so well sold to the media and the general public that it proved to be a double-edged sword. The EPA, then the FDA and later the OSHA discovered that they could equally use these claims and extrapolation techniques to justify their stance on restricting some of the less-defined, chronic, long-term health hazards. The EPA's ETS Risk Assessment became a major threat to the tobacco industry because it was sure to show that passive smoking produced low-level, and unconscionable rates of lung cancer among non-smokers.
When the cosmetic gloss of "umbrella science" of "Decision-making" is removed, the claims for Risk Science rested on the myth that:
- subjective judgements of highly variable degrees of dangers (largely unknown or unknowable)
... could be combined and reengineered through an ... - objective Decision-making science
... (without the need for expertise in toxicology, biomedicine, epidemiology, etc) to provide ... - rational and transparent treatment, involving cost-benefit analysis ...
... thus producing an objective 'factual' determination.
In fact Risk Science owes more to ideology and public relations than does to any scientific approach to problem solving.
But the promotion of Risk Assessment or Risk Analysis appealed to many industries and corporations with poisoning or polluting problems because it allowed them to put their own consulting experts in the driver's seat of regulation. They began promoting Risk Science publications, gave healthy donations to Risk think-tanks and institutes, funded Risk chairs at universities, and generally supported the Risk ideology for decades from the mid 1980s. The industries which promoted these ideas the most, were tobacco with its health and pollution problems, the chemical industry with its dioxin, formaldehyde and general pesticides problems, and the energy industry with the threat of climate change. They were the same industries which often attacked the idea of science itself, and promoted the concept of "junk-science".
At Philip Morris, the support for these efforts came under the Science Issues division run by Tom Borelli and Amy Millman -- both scientific lobbyists -- not scientists. Their aim was to influence Risk Assessment definitions, and to discount or abolish those features of guidelines and regulations that condemned the company's products.
Components of Risk Science
- Risk Analysis and Risk Assessment (upper and lower case versions)
These are essentially the same, or they overlap to such a degree that they can't easily be separated. They need to assess/analyse both:
- the overall risk of the object, the substance or the practice
- the sub-fractions or elements of the whole
- Risk Management
This assumes that the risk, as determined, is low enough to be acceptable if correctly managed. The Delaney Clause of the Federal Food Drug and Cosmetics Act prohibits the deliberate introduction of any level of a known carcinogen into the food supply. Management here means 'prohibition'.
Some tobacco documents also introduce the concept of:
- Acceptable Risk
Documents & Timeline
1973 The Federal Drug Administration proposed the use of a primitive form of risk assessment methodology - together with a life-time risk target of one in a million (for upper limits) for human exposure to certain food additives that had proven to be carcinogenic in animal tests. This was the inverse definition of "safety" which it defined as "reasonable certainty of no harm. " [2]
1983 Mar 8 The first appearance of Environ Corp. in the tobacco archives is in an Occupational Health & Safety Letter. Tobacco lobbyist Joseph V Rodricks is listed along with some others as an author of a report "Risk Assessments in the Federal Government: Managing the Process." (Vincent T Covello and JJ Cohrssen were the principle authors.) [3]
Their paper notes that the "... basic problem with risk assessment is the sparseness and uncertainty of the scientific knowledge of the health hazards addressed. Although evidence of health effects of a few chemicals, such as asbestos, has been clear, in many cases the evidence is meager and indirect. To make regulatory judgements on the basis of animal data, risk assessors must rely on a series of assumptions." [4]
1983 (The Proceedings of the International Workshop on ...) The Analysis of Actual Versus Perceived Risks edited by:
- Vincent T Corvello, National Science Foundation (later Columbia Uni, School of Public Health)
- W Gary Flamm, FDA -- who later became a full-time science lobbyist and corrupter for the tobacco industry.
- Joseph V Rodricks, listed at his new firm Environ Corporation, Washington DC (recruited by Covington & Burling in May 1983 [5]
- Robert G Tardiff, National Academy of Science (who later joined Rodricks at Environ Corp.
- [Note the first page is not connected with the main document] [6]
1985 Spring The foundation textbook of this new scientific discipline was published: Risk, Science and Democracy by William D Ruckelshaus in Science and Technology (Vol 1 No 3) Published by: University of Texas at Dallas [7]
1987 Apr 17 Risk assessment in environmental policy-making by M Russell, M Gruber in Science Vol. 236, Issue 4799,
Environmental policy-making has become more dependent on formal, quantitative risk assessment because of increasing attention to the prevention of human health damage from toxic chemicals. Risk assessment helps set priorities for regulation of the very large numbers of chemicals that are of potential concern and helps direct limited social and government resources against the most significant risks. Although the scientific basis for risk assessment is often uncertain and the public and its representatives have often been confused by its use in regulatory decisions, the U.S. Environmental Protection Agency currently uses a variety of risk assessment techniques to set priorities, tailor regulations, and make decisions at particular sites. The Environmental Protection Agency also attempts to make the practice of risk assessment more consistent throughout the agency and to improve public understanding of the meaning of risk assessment and risk management.[8]
1987 Sep 18 The ISLI-Nutritional Foundation is actively organising opposition to California's Proposition 65 (Clean Air, Clean Water Act). They have hired Dr Catherine St. Hilaire as director of their new ILSI Risk Science Institute, and she is supported by a Scientific Advisory Board (SAB) which is compiling a list of chemicals :known to cause cancer"
Dr . Drotman reviewed the petition submitted to the California Health and Welfare Agency (HWA) by the Environmental Working Group (EWG) requesting that the HWA adopt Proposed Regulations as binding regulations to implement, interpret and make specific the provisions of Proposition 65.
The intent of the petition is to work the interpretive guidelines into a proposed regulation. The petition also includes a statement of reasons explaining the Proposed Regulations as well as the technical and legal justification for them.
Dr . Drotman announced that the Scientific Advisory Panel will sponsor a workshop in early December on : defining "known to cause cancer," identifying appropriate risk assessment methodologies for carcinogens, and defining "significant risk." [[9]
1989 Aug John Graham at the Harvard School of Public Health decides to get in on the Risk Science business. He establishes the Harvard Center for Risk Analysis and gets an amazing amount of funding from large corporations. He boasts of backing from car, oil, energy and chemical companies:
| INITIAL BACKERS OF THE HCRA | |||
|---|---|---|---|
| Amoco Company, | Bethlehem Steel Corporation, | British Petroleum, | Chevron Corporation, |
| The Coca Cola Company, | Dow Chemical Company, | Eastman Kodak Company, | Exxon Corporation, |
| General Electric Corporation, | General Motors, | lnland Steel Industries, | Merck & Company ; |
| Mobil Oil Corporation, | Monsanto Company | Pepsico Incorporated, | Rohm and Haas Company, |
| Texaco, | Union Carbide Corporation, | Westinghouse Corporation | |
| Government support has also been provided by the | |||
| Centers for Disease Control, | US Department of Transportation, | National Science Foundation. | |
1991 Oct 28 John Graham makes an approach to Philip Morris, asking for $25,000 pa so he will continue to support their claims that passive smoking (ETS) is only a minor problem (if at all) and that the government agencies should focus on major problems. He points out that in 1989-90 they "exposed serious weaknesses in the federal government's risk assesment process on air toxics" - and introduced risk analysis techniques which which will "assure sound implementation of the upcoming amendments to the Clean Air Act." And in 1990-91 they "played a pivotal role in the congressional debate on fuel economy standards" (they opposed the emphasis on smaller fuel economic cars, because of their supposed "increased safety risk")
The HCRA wanted the tobacco funding to "train young professionals how to think about risk in a balanced way, to target limited technical and human resources at the most important problems and to participate vigorously in public policy debates about risk." [10]
Robert Pages at Philip Morris is highly cynical about "Risk Sciences" but he advises Steve Parrish (a lawyer who has just become VP of Corporate Affairs)
Sure, he's after dollars to help support his Center, but whether or not PM decides to contribute it's more important to meet him and perhaps get 'looped in' better with his activities. From all that Mayada has learned, he is a key player in all this risk analysis stuff that's current going on in government. [11]
1993 Dec Perceived Risk, Trust, and Democracy by Paul Slovic
Risk management has become increasingly politicized and contentious. Polarized views, controversy, and overt conflict have become pervasive. Risk-perception research has recently begun to provide a new perspective on this problem. Distrust in risk analysis and risk management plays a central role in this perspective. According to this view, the conflicts and controversies surrounding risk management are not due to public ignorance or irrationality but, instead, are seen as a side effect of our remarkable form of participatory democracy, amplified by powerful technological and social changes that systematically destroy trust. Recognizing the importance of trust and understanding the “dynamics of the system” that destroys trust has vast implications for how we approach risk management in the future.[12]
1996 May The Reason Foundation releases material generated by the Harvard Center for Risk Analysis:
"Key Issues in Environmental Risk Comparisons: Removing Distortions and Insuring Fairness" which had been written by:
- George M Gray (principle author). He had been John Graham's deputy at HCRA.
- Kenneth Green (Reason project director). Senior Environmental Policy Analyst
- Lynn Scarlett (Reason project director). She was a member of the HCRA and Harvard Group on Risk Management Reform (HGRMR)
1999 Aug Trust, Emotion, Sex, Politics, and Science: Surveying the Risk-Assessment Battlefield, By Paul Slovic
Risk management has become increasingly politicized and contentious. Polarized views, controversy, and conflict have become pervasive. Research has begun to provide a new perspective on this problem by demonstrating the complexity of the concept “risk” and the inadequacies of the traditional view of risk assessment as a purely scientific enterprise. This paper argues that danger is real, but risk is socially constructed. Risk assessment is inherently subjective and represents a blending of science and judgment with important psychological, social, cultural, and political factors. [14]
