Skip to main content

1987 | Buch

De Minimis Risk

herausgegeben von: Chris Whipple

Verlag: Springer US

Buchreihe : Contemporary Issues in Risk Analysis

insite
SUCHEN

Über dieses Buch

On May 29 and 30, 1985, a workshop was held to explore the legal, ethical, social, scientific, and practical aspects of the use of the de minimis risk concept for health and safety regulation. The workshop was sponsored by the Society for Risk Analysis and its National Capital Area Chapter, the Environmental Protection Agency, the Nuclear Reg­ ulatory Commission, and the Electric Power Research Institute. The two-day meeting was held in Washington, D. C. , at the Brookings Institution; however, the Brookings Institution was not a sponsor of the meeting and did not playa role in its program. De minimis risk policy considerations were addressed from a theoretical and phil­ osophical viewpoint, from a quantitative and methodological basis, and through insights gained with regulatory applications. The distinctions between these three approaches to the subject are not sharp; most papers in these proceedings address aspects of all three topics. The reader familiar with the literature on the use of risk assessment in regulatory policy and decision making will find significant new contributions to the field. One of these is the examination of regulatory actions-in particular actions by the EPA-in response to risks of varying magnitude. Many attempts to seek patterns in regulatory policies have been based on analysis of the implicit economic value in obtaining risk reductions. These analyses have typically found great variability in the marginal cost­ 1 effectiveness of regulatory actions.

Inhaltsverzeichnis

Frontmatter

De Minimis Risk Regulation

Frontmatter
1. De Minimis Risk
From Concept to Practice
Abstract
The statutes that govern federal regulation of environmental and technological risks represent the attempts of Congress to establish intelligible goals and principles as a guide for regulatory agencies. However, the statutory language frequently includes absolute statements that cannot realistically be satisfied or ambiguous statements that provide inadequate guidance. As a result, the regulatory process has often been hampered by difficulties in interpreting the intent and substance of the statutes, particularly in the context of low-level chronic risks.
Joseph Fiksel
2. De Minimis Risk as a Regulatory Tool
Abstract
Management of the health, safety, and environmental risks associated with various hazards has become increasingly difficult. To a large extent this difficulty can be traced to the fact that agencies are confronted with a seemingly unlimited number of risks and they have limited resources for managing such risks. One means proposed for dealing with this management problem is based on the legal principle de minimis non curat lex or, “the law does not concern itself with trifles;” hence the term “de minimis risk.” According to this principle, risks considered trifling can be eliminated from regulatory consideration. Although the de minimis approach has been the subject of increased interest and agency use, the problems associated with its use need to be more fully addressed. In this chapter we (1) describe the concept of de minimis risk, (2) discuss several problems associated with the de minimis concept, and (3) conclude that the viability of the de minimis risk concept is not as compelling as some analysts have suggested.
Joshua Menkes, R. Scott Frey
3. Application of the De Minimis Concept in Risk Management
Abstract
In risk regulation and management, de minimis refers to the general theme that some risks are too small to be of societal concern. It is easy to show that all organizations with risk management responsibilities use some type of de minimis approach, since risk management resources are always finite, and the supply of very small risks virtually inexhaustible. To cite just one example, the prohibition of carcinogenic food additives under both the Delaney Clause and earlier food safety laws is commonly cited as a “zero risk” policy statement that is as protective as any risk policy on the federal level. Even so, no serious consideration has ever been given to the idea that the Food and Drug Administration should ban food additives that contain a radioactive molecule or two, since that would include virtually all substances. While all organizations with risk management responsibility follow some pragmatic de minimis approach, there has been a series of proposals (see Chapter 13 and Davis1 for a general review of the issue) for explicit adoption of the de minimis concept by regulatory agencies.
Chris Whipple
4. Science and Its Limits
The Regulator’s Dilemma
Abstract
William Ruckelshaus, in his beautiful essay “Risk, Science and Democracy,”1 has expressed very clearly what I shall call the regulator’s dilemma. “During the past 15 years there has been a shift in public emphasis from visible and demonstrable problems, such as smog from automobiles and raw sewage, to potential and largely invisible problems, such as the effects of low concentrations of toxic pollutants on human health. This shift is notable for two reasons. First, it has changed the way in which science is applied to practical questions of public health protection and environmental regulation. Second, it has raised difficult questions as to how to manage chronic risks within the context of free and democratic institutions.”1
Alvin M. Weinberg

Quantitative Aspects of De Minimis Risk

Frontmatter
5. Significant Risk Is Not the Antonym of De Minimis Risk
Abstract
Recent events have led to an increased interest in a “significant risk” policy for the regulation of exposures to toxic chemicals. In 1980 the Occupational Safety and Health Administration (OSHA) promulgated a rule in which the standard for any carcinogen was to be lowered to the extent technologically and economically feasible.1 In a 1980 decision, the Supreme Court vacated a rule that established a standard for exposure to benzene, based on a statutory interpretation, although the Court did not overturn OSHA’s entire cancer policy.2 An agency had to make a finding that a risk was significant before it could consider regulating it, and the finding had to be part of the record.
Daniel Byrd III, Lester Lave
6. On Defining a De Minimis Risk Level for Carcinogens
Abstract
Several attempts have been made to use the variation in the levels of natural background radiation to define an acceptable level risk for man-made radiation. The philosophical basis for such proposals is that since no correlations have been detected between variations in natural background radiation and adverse health effects, small additions to natural exposure should be acceptable. The difficulty lies in defining “small.” In 1978, Adler and Weinberg proposed using the standard deviation of background radiation levels as a method for establishing radiation exposure limits (Adler and Weinberg 1978). The Adler and Weinberg proposal results in the suggestion that a lifetime cancer risk of about 10−4 is de minimis.* The Adler and Weinberg de minimis risk level was based on the standard deviation of human exposure to background terrestrial and cosmic radiation. We propose to determine the risk levels associated with the standard deviation of human exposure to other radioactive and chemical carcinogens.
Curtis C. Travis, Samantha A. Richter
7. De Minimis Risk and the Integration of Actual and Perceived Risks from Chemical Carcinogens
Abstract
We all face a nontrivial lifetime risk of death equal to 1. It is against this ultimate benchmark that all risks must be evaluated. But we all recognize that we also have a considerable diversity of opinions, of values, of analytical approaches, and of philosophy in terms of how best to handle all the component risks, including those for which society is responsible.
Paul Milvy
8. Carcinogenic Potencies and Establishment of a Threshold of Regulation for Food Contact Substances
Abstract
This chapter presents a compilation of data on carcinogenic potencies in the form of a probability distribution and describes how, in this form, the data could be used as a scientific foundation for making regulatory judgments about the potential risk from substances that migrate to food from packaging and other materials that come into contact with food. The idea of establishing a threshold of regulation based on the concept of a de minimis level of migration of potentially carcinogenic substances into food is discussed as a possible regulatory approach that could use the type of data presented. The discussion does not represent Food and Drug Administration (FDA) policy, however, and it does not address the possible use by FDA of a de minimis risk approach to determining the status of certain color additives currently being evaluated by the agency.
W. Gary Flamm, L. Robert Lake, Ronald J. Lorentzen, Alan M. Rulis, Patricia S. Schwartz, Terry C. Troxell

Regulatory Applications of De Minimis Risk

Frontmatter
9. Implications of De Minimis Risk Concepts for OSHA
Abstract
The legal framework provided by the Occupational Safety and Health Act of 1970 and by subsequent Supreme Court decisions interpreting that law are a logical starting point for discussion of de minimis risk concepts and their application in OSHA. If we work initially in that legal dimension, the social, ethical, and practical dimensions will quickly become apparent. In these remarks, I hope to point out where de minimis concepts have been successfully applied already, and to point toward program areas where they may apply in the future.
Raymond E. Donnelly
10. Applications of De Minimis
Abstract
The concepts of a nonthreshold pollutant (such as radiation) and of de minimis are essentially contradictory—the first states that there is no level of exposure that does not produce some harm, the second that there is some defined threshold below which there is no concern. It is the job of the regulatory agencies to see if these concepts can be reconciled and, more important, produce some benefit. As we shall see, this is a process of compromise and not of absolutes.
Sheldon Meyers
11. The NCRP Considerations on Levels of Negligible Risk
Abstract
NCRP’s Committee 1, under the chairmanship of George Casarett, has approached the de minimis question from the standpoint of risk. In the document approved by the council there is a recognition that even with the prudent assumption of a linear relationship between risk and dose, there must exist a risk and its attendant dose that is negligible (NCRP 1987).
Charles B. Meinhold
12. A Summary Perspective on NRC’s Implicit and Explicit Use of De Minimis Risk Concepts in Regulating for Radiological Protection in the Nuclear Fuel Cycle
Abstract
There is a growing recognition of the desirability in public policy making regarding a cutoff standard of insignificant risk to base this on reference values of common use that roughly characterize the levels of individual risk that are regarded as sufficiently negligible not to merit additional personal expenditures to reduce them further. According to Clarke of the U.K. National Radiological Protection Board, there is a widely held view that few people would commit their own resources to reduce an annual risk of death of 1 chance in 100,000 and that even fewer would take action at a chance of 1 in 1 million per year of exposure to a given hazard.1
Miller B. Spangler
13. The Feasibility of Establishing a De Minimis Level of Radiation Dose and a Regulatory Cutoff Policy for Nuclear Regulation
Abstract
This report discusses the feasibility of a de minimis policy for radiation exposure guidance and regulation. This policy would establish a threshold below which regulation of radiation sources, practices, or exposures would be deliberately and specifically curtailed. While a similar policy would probably be appropriate for other environmental agents (e.g., chemical carcinogens), discussion of that aspect of the subject is outside the scope of this report.
Joyce P. Davis
Backmatter
Metadaten
Titel
De Minimis Risk
herausgegeben von
Chris Whipple
Copyright-Jahr
1987
Verlag
Springer US
Electronic ISBN
978-1-4684-5293-8
Print ISBN
978-1-4684-5295-2
DOI
https://doi.org/10.1007/978-1-4684-5293-8