Gru nd legung zur Metaphysik der Sitten

Four thousand eighty inbred rats were maintained from weaning on various different concentrations of N-nitrosodiethylamine (NDEA) or N-nitrosodimethylamine (NDMA). The principal aim was to characterize the dose-response relationship for the effects of these agents on esophageal cancer (NDEA) or on various types of liver cancer (NDEA and NDMA), although NDEA also caused a few tumors of the nasopharynx and NDMA also caused a few tumors of the lung. The numbers of tumors of mesenchymal and Kupffer cells in the liver were too few to allow easy characterization of the dose-response relationships, and although NDMA induced large numbers of bile duct neoplasms, NDEA did not. Thus, the four principal dose-response relationships studied were of NDEA on esophageal or liver cells and of NDMA on bile duct or liver cells. At doses sufficiently high for the median time to death from the disease of interest to be estimated, relationships were observed of the general form (Dose rate) x (median)n = constant where n was about 2.3 for the first three relationships and about 1 for the last one (NDMA on liver cell tumors). By contrast, at doses sufficiently low for longevity to be nearly normal (median survival about 2.5 years), there remained no material dependence on the dose rate of the age distribution of the induced neoplasms. At these low dose rates, the number of liver (but not of esophageal) neoplasms induced by treatment was simply proportional to the dose rate. This finding is not surprising, since the background incidence of liver (but not of esophageal) neoplasms was appreciable. The linear relationship observed at low dose rates (below 1 ppm) suggests that under these experimental conditions, among rats allowed to liver their natural life span, a dose of 1 ppm of NDEA or NDMA in the drinking water will cause about 25% to develop a liver neoplasm, a dose of 0.1 ppm will cause about 2.5% to do so, and a dose of 0.01 ppm will cause about 0.25% to do so, etc., with no indication of any \"threshold.\" (At these low dose rates, the incidence of liver neoplasms appears likely to exceed greatly that of esophageal neoplasms.) In addition, even quite low dose rates of the test agents caused a variety of nonneoplastic liver abnormalities (e.g., hyperplastic nodules, or shrinkage of hepatocytes) at a frequency roughly proportional to the dose rate.

Effects on 4080 rats of chronic ingestion of n-nitrosodiethylamine or n-nitrosodimethylamine - a detailed dose-response study - fundamental carcinogenic processes and their implications for low-dose risk assessment - reply

Lives Probably the most vexing problem raised by the cost-benefit analysis of environmental regulation is how to deal with the fact that the loss of human life generally does not occur contemporaneously with the exposure to certain contaminants. In some cases, the environmental exposure produces a harm with a latency period whereas in others it produces harms to future generations. The article underscores the extent to which the cases of latent harms and harms to future generations are analytically distinct, even though they have generally been treated as two manifestations of the same problem. In the case of latent harms, one needs to make intra-personal, intertemporal comparisons of utility, whereas in the case of harms to future generations what is needed is a metric against which to compare the utilities of individuals living in different generations. Thus, the appropriateness of discounting would be resolved differently in the two contexts.

Environmental Regulation, Cost-Benefit Analysis, and the Discounting of Human Lives

– Despite a longstanding recognition that radiological protection is not only a matter of science, but also ethics, ICRP publications have rarely addressed the ethical foundations of the system of radiological protection explicitly. The purpose of this publication is to describe how the Commission has relied on ethical values, either intentionally or indirectly, in developing the system of radiological protection with the objective of presenting a coherent view of how ethics is part of this system. In so doing, it helps to clarify the inherent value judgements made in achieving the aim of the radiological protection system as underlined by the Commission in Publication 103. Although primarily addressed to the radiological protection community, this publication is also intended to address authorities, operators, workers, medical professionals, patients, the public, and its representatives (e.g. NGOs) acting in the interest of the protection of people and the environment. This publication provides the key steps concerning the scientific, ethical, and practical evolutions of the system of radiological protection since the first ICRP publication in 1928. It then describes the four core ethical values underpinning the present system: beneficence/ non-maleficence, prudence, justice, and dignity. It also discusses how these core ethical values relate to the principles of radiological protection, namely justification, optimisation, and limitation. The publication finally addresses key procedural values that are required for the practical implementation of the system, focusing on accountability, transparency, and inclusiveness. The Commission sees this publication as a founding document to be elaborated further in different situations and circumstances.

https://journals.sagepub.com/doi/pdf/10.1177/0146645317746010

ICRP Publication 138: Ethical Foundations of the System of Radiological Protection.

Following the Fukushima accident, the International Commission on Radiological Protection (ICRP) convened a task group to compile lessons learned from the nuclear reactor accident at the Fukushima Daiichi nuclear power plant in Japan, with respect to the ICRP system of radiological protection. In this memorandum the members of the task group express their personal views 13 The authors are the members of Task Group 84 of the International Commission on Radiological Protection (ICRP), which was convened by the ICRP to collate the lessons learned from the nuclear reactor accident at the Fukushima Daiichi nuclear power plant in Japan. The opinions expressed are those of the authors and do not necessarily reflect the official view of the ICRP.

/pdf/radiological-protection-issues-arising-during-and-after-the-1v8pkss04y.pdf

Radiological protection issues arising during and after the Fukushima nuclear reactor accident

Low Dose Exposures in the Environment

The establishment of standards for tolerable, or acceptable risks in connection with exposure to noxious agents might seem to be exclusively a matter of sound scientific methodology in estimating the probabilities for damages and reducing the uncertainties involved in extrapolating from the known into the unknown. However, the setting of standards for acceptable risk is not just a matter of probabilities and degrees of uncertainty. Acceptability is a normative notion and involves a number of factors having to do with values and human autonomy that will be discussed in the following. Whoever makes the decision, whether an individual, a group, an industrial firm or a public institution or agency, there is a number of norms and values that come into the picture, such as consent, distributional justice, and many others that will be discussed in this chapter. Some of these normative factors have been included in laws and regulations in various ways that often differ from country to country, while others are not laid down in law, but remain as ethical considerations that any decision maker should take into account.

Ethical Aspects of Risk

From a legal perspective the protection of human life and health against possible adverse effects of low doses raises two different preliminary questions: the first problem is whether the state or — in the case of the European Community — the Community is under an obligation to protect human life and health against low doses; secondly, one has to ask the question whether and to what extent the state or the Community is empowered to deal with low doses.

Low Doses in Health-Related Environmental Law

The basic toxicodynamic principles of chemically and of radiation-induced carcinogenesis are largely identical. However, toxicokinetic factors of uptake, distribution, metabolism and elimination of chemical compounds lead to further complications. A chemical carcinogen may either act in the form of the parent compound, or, very frequently, in the form of an ultimately active metabolite. Hence, a complicated interplay of activating and inactivating enzyme systems must be considered in performing low-dose extrapolations. This chapter provides some outstanding examples of typical ways of argumentation.

Toxicology of Chemical Carcinogens

Biological risks of ionising radiation were identified only a few years after the discovery of X-rays by Roentgen (1895) and of radioactivity by Becquerel (1896). At the end of the 19th and beginning of the 20th century radiation-induced skin cancers have been described (Trott and Streffer 1991). Therefore it was very soon necessary to determine standards and dose limits for ionising radiation for persons at working places and later, also for individuals of the general population. The first standards were defined in the twenties and developed during the 20th century based on that knowledge about the action of ionising radiation, which was available at the corresponding times. For risk evaluations, the shape of the dose-effect curves is of eminent significance. In radiation research as well as in toxicology of chemicals in general two principal categories of dose-effect relationships have been described (ICRP 1977). The shape of these curves is based on manifold experimental studies of radiation effects which have been investigated with molecular structures, cells and animals after radiation exposures and obtained from clinical experiences as well as from epidemiological studies which have been observed after the exposure to ionising radiation in man (UNSCEAR 1977, 1988, 1993, 1994, 2000, BEIR 1990). The principal and fundamental difference of these dose-effect relationships is very important in the low-dose range.

Effects of Ionising Radiation in the Low-Dose Range — Radiobiological Basis

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