Carl F. Cranor

Some Moral Issues in Risk Assessment

Major social institutions of a community, for example, the scientific, legal, religious institutions, in coping with the same problem or with aspects of a particularly complex problem may have practices that they follow or principles guiding their methods of inquiry that are inconsistent with one another. When this occurs, it is crucial to provide a consistent solution to the conflict, or there will be an intellectual and probably practical tension between the institutions. More seriously, if the inconsistency is not identified and resolved, principles of one institution may unknowingly influence or determine the deliberations and outcomes of another. It is the thesis of this article that the very demanding evidentiary standards adopted for scientific inquiry, where pursuit of truth for its own sake is the main goal, in many cases will unwittingly beg the outcome of debates about health care protections in our legal and regulatory institutions, where the evidentiary standards are much less demanding. It is not simply that the standards of good evidence are different, although that is true. Rather, in some very common circumstances in which scientific evidence is used as the basis of standard setting in regulatory law or as evidence of harm in a toxic tort suit, adherence to scientific standards of evidence, whether by scientists or by policymakers or judges, will force legal conclusions that would not be justified if they were based on the appropriate evidentiary standards in the law. The problem I allude to may well arise because scientists unwittingly adopt evidentiary standards for the use and reporting of statistical studies for regulatory or toxic tort

Toward Understanding Aspects of the Precautionary Principle

The idea of a precautionary principle (or precautionary principles) is beginning to come to the wider attention of the environmental community, governmental agencies, regulatory agencies, and the regulated community. Different precautionary principles have not been specified in detail, and, of course, this is difficult to do. Yet some specification must be done in order to understand it better and, if it is to be used for specific action-guidance, to implement it. Moreover, it is important to understand more about the principle, its background assumptions and its comparison with other principles to which we might subscribe. This paper explores aspects of the PP and its background assumptions and presuppositions, comparing them with those for risk assessment and other statements of the PP. It also briefly indicates how it resembles legal principles in addressing problems of uncertainty. Finally, it recapitulates two possible versions of the PP and suggests an application of it for an emerging threat to the environment and public health. This review suggests the PP has plausible applications and is not the radical principle some have suggested.

Scientific Inferences in the Laboratory and the Law

Following the Supreme Courts Daubert v Merrell Dow Pharmaceuticals, Inc decision, courts have struggled in reviewing scientific evidence and appear to have appreciated insufficiently the nature of scientific reasoning. To assist their evidentiary reviews, courts need to appreciate both scientific complexity and ignorance about human toxicity caused by the universe of chemical substances. Conscientious, well-motivated, respectable experts can come to different conclusions about scientific evidence without making obvious mistakes and without being charlatans. So that justice is done between parties, courts need to allow for reasonable scientific disagreement to avoid excluding from trials respectable experts and all relevant scientific evidence. The public health community can assist courts to understand ranges of scientific evidence and to recognize the reasonableness of scientific disagreements.

How Should Society Approach the Real and Potential Risks Posed by New Technologies

As the 21st century opens, two new technologies raise the promise of benefits for humankind—biotechnology and nanotechnology. Crop biotechnology promises new and improved foods, e.g. vitamin A-enhanced rice ( Oryza sativa ), more food at lower cost from highly productive plants, plants that will

Scientific and legal standards of statistical evidence in toxic tort and discrimination suits

Many legal disputes turn on scientific, especially statistical, evidence. Traditionally scientists have accepted only that statistical evidence which satisfies a 95 percent (or 99 percent) rule — that is, only evidence which has less than five percent (or one percent) probability of resulting from chance.The rationale for this rule is the reluctance of scientists to accept anything less than the best-supported new knowledge. The rule reflects the internal needs of scientific practice. However, when uncritically adopted as a rule for admitting legal evidence, the seemingly innocuous 95 percent rule distorts the balance of interests historically protected by the legal system. In particular, plaintiffs in toxic tort and employment discrimination suits are effectively held to a heavier burden of proof in showing that their injuries were more probably than not caused by the defendants actions. The result is that too many victims of toxic torts or employment discrimination cannot win legal redress for their injuries.Proposals to adopt stringent scientific rules of evidence thus implicate significant philosophical issues about the relation of evidence to belief and to practical action. The underlying objectives of the tort law system are not those of scientific practice, and each set of objectives has standards of evidence specific to it.

Regulating Chemicals: Law, Science, and the Unbearable Burdens of Regulation

The challenges of regulating industrial chemicals remain unresolved in the United States. The Toxic Substances Control Act (TSCA) of 1976 was the first legislation to extend coverage to the regulation of industrial chemicals, both existing and newly registered. However, decisions related to both law and science that were made in passing this law inevitably rendered it ineffectual. Attempts to fix these shortcomings have not been successful. In light of the European Unions passage of innovative principles and requirements for chemical regulation, it is no longer possible to deny the opportunity and need for reform in US law and practice.

Eggshell skulls and loss of hair from fright: some moral and legal principles that protect susceptible subpopulations

Some of the legislation authorizing the Environmental Protection Agencys (EPA) regulation of toxic substances, principles deeply embedded in our legal system, and some moral principles tend to support the claim that all of us, even the most susceptible, have equal standing to be protected from harms from toxic substances. Information about susceptible subpopulations should be part of risk assessment, either as default considerations or as a result of empirical research. Risk assessment is the step in a regulatory process where higher risks to sensitive subpopulations should be recognized regardless of the statute authorizing agency action. If we do not acknowledge susceptible subpopulations in risk assessment, this suggests that they do not have sufficient standing to be protected. Such a view would be unacceptable. However, because full protection for susceptible subpopulations might be costly, risk managers may have to be imaginative in finding regulatory options to provide these protections.

Some Legal Implications of the Precautionary Principle: Improving Information-Generation and Legal Protections

ABSTRACT In creating a legal agenda in service of the Precautionary Principle, the idea of precaution requires more inventories and better monitoring of the condition of public and workforce health than at present. Rectifying problems of the past to better serve the aims of precaution will require more affirmative pre-market and much more post-market knowledge-generation by those who create and use potentially toxic substances, improved pre-market review of substances, better responses to early warnings, and quicker protective post-market responses to evidence of toxicity. This paper conceptualizes a model pre-market screening law to highlight the need for primary prevention measures and to provide philosophic ideas for improving post-market laws and addressing a large universe of existing substances that have been poorly characterized. Although retrospective personal injury law does not have good mechanisms for precaution, even this can be more protective than it is at present by enhancing causes of action for reasonable fear of disease and medical monitoring, and moving to create new causes of action for failure to develop and disseminate information needed to assess the toxicity of substances.

Why Chemical Risk Assessment can Learn from Radiation Risk Assessment

Abstract The biological models for radiation and many chemicals have been seen as having some substantial differences. Radiation has no lowest exposure at which adverse health effects result and the dose–response curve has been assumed to be linear from levels at which it can be measured to the no exposure level. In contrast, some chemical exposures have been assumed to have threshold effects, exposure levels below which for a chemical taken in isolation no adverse health effects occur. Recent research reveals that the assumptions for toxicological risk assessment should be modified to more closely resemble risk assessments for radiation. In short, the presumptions for toxicological risk assessment should be modified.

Toxic Substances and Agenda 21: Ethical and Policy Issues in the Science and Its Implementation

This chapter addresses some of the scientific tools for assessing risks from toxic substances, one of the major concerns of the United Nations Agenda 21 (Chapter 19). One cannot, however, treat this as merely a technical or scientific problem. As I argue throughout, the science itself is laden with normative considerations. An important policy question is the extent to which public health and environmental threats should be addressed as if they were merely scientific or technical questions. We need an ethic or policy decision about how much scientific evidence of harm to demand before taking preventive or remedial action. We should also understand the normative, indeed moral, commitments that are implicit in the scientific procedures themselves and in the practices of the professions that implement them. For example, implicit in typical scientific procedures are normative commitments, burdens of proof, and practices for addressing scientific uncertainty that can easily frustrate health-protective and environmentally protective courses of action of the kind envisioned in Agenda 21 for dealing with hazardous materials and toxic substances. Failure to revise present scientific practices will tend to favor the status quo of ignorance about potentially toxic substances and of slow governmental action, while improvements of both would mitigate these problems. Present scientific practices used in risk assessment need evaluation and revision in order not to enshrine the status quo ante.