[Scientific assessment and regulatory approval of radiological screening examinations in Germany]. / Wissenschaftliche Bewertung und rechtliche Zulassung von radiologischen Früherkennungsuntersuchungen in Deutschland.

BACKGROUND: Radiologic imaging technologies like computed tomography (CT) have the potential to screen for various diseases. The potential benefits of screening are always associated with risks, particularly from the application of ionizing radiation. MATERIALS AND METHODS: The International Basic Safety Standards as well as the Council Directive 2013/59/Euratom have set guidelines for the application of ionizing radiation in early detection which were transposed into the German Radiation Protection Law. Accordingly, the German Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) approves screening examinations on a generic level, based on a scientific report provided by the German Federal Office for Radiation Protection (BfS), and defines in a federal statutory ordinance which type of screening is permissible for detecting a disease for a particular group of persons and under which conditions. RESULTS: With exception of the mammography screening programme, no radiological examination for the early detection of disease has been approved in Germany to date. However, such screenings are currently being offered in Germany. The BfS is currently conducting a scientific evaluation for lung cancer screening with low-dose CT. CONCLUSIONS: Screening examinations with radiological imaging can only be approved when studies with the highest level of evidence have demonstrated that the benefits outweigh the risks. To translate this favourable benefit-risk balance into general health care, strict requirements for the entire screening process including quality assurance must be defined.

[Frequency and doses of diagnostic and interventional X­ray applications : Trends between 2007 and 2014]. / Häufigkeit und Dosis diagnostischer und interventioneller Röntgenanwendungen : Trends zwischen 2007 und 2014.

BACKGROUND: In Germany, approximately 95% of man-made radiation exposure of the population results from diagnostic and interventional X­ray procedures. Thus, radiation protection of patients in this field of application is of great importance. OBJECTIVE: Quantification and evaluation of current data on the frequency and doses of X­ray procedures as well as temporal trends for the years 2007-2014. MATERIAL AND METHODS: For outpatients the frequency of X­ray procedures was estimated using reimbursement data from health insurances and for inpatients by means of hospital statistics. For the years under review, representative values for the effective dose per X­ray application were determined mainly from data reported by X­ray departments to the competent authorities. RESULTS: In 2014 approximately 140 million X­ray procedures were performed in Germany with some 40% from dental examinations. On average 1.7 procedures per inhabitant and year were almost constantly carried out between 2007 and 2014. Besides dental diagnostics, X­ray examinations of the skeleton and thorax were performed most frequently. The number of computed tomography (CT) examinations increased by approximately 40%. The increase in magnetic resonance imaging (MRI) was even more pronounced with approximately 55% but overall CT examinations were still performed more often than MRI. The doses per X­ray procedure were only slightly reduced, despite the various dose reduction approaches established in recent years; therefore, the mean effective dose per inhabitant increased from approximately 1.4 mSv in 2007 to 1.6 mSv in 2014, mainly due to the increasing frequency of CT examinations. CONCLUSION: The principles of justification and optimization of radiological procedures are to be consistently applied in each individual instance, especially in the case of CT examinations.

Prospective Evaluation of the radiologist's hand dose in CT-guided interventions.

PURPOSE: Assessment of radiologist's hand dose in CT-guided interventions and determination of influencing factors. MATERIALS AND METHODS: The following CT-guided interventions were included: Core biopsy, drainage, periradicular therapy, and celiac plexus neurolysis. The hand dose was measured with an immediately readable dosimeter, the EDD-30 (Unfors, Sweden). The default parameters for CT fluoroscopy were 120 kV, 90 mA and a 4 mm slice thickness. All interventions were performed on a 16-slice CT unit (Aquilion 16 Toshiba, Japan). The tumor size, degree of difficulty (1 - 3), level of experience and device parameters (mAs, dose-length product, scan time) were documented. RESULTS: 138 CT-guided interventions (biopsy n = 99, drainage n = 23, pain therapy n = 16) at different locations (lung n = 41, retroperitoneum n = 53, liver n = 25, spine n = 19) were included. The lesion size was 4 - 240 mm (median: 23 mm). The fluoroscopy time per intervention was 4.6 - 140.2 s (median: 24.2 s). The measured hand dose ranged from 0.001 - 3.02 mSv (median: 0.22 mSv). The median hand dose for lung puncture (n = 41) was slightly higher (median: 0.32 mSv, p = 0.01) compared to that for the liver, retroperitoneum and other. Besides physical influencing factors, the degree of difficulty (p = 0.001) and summed puncture depth (p = 0.004) correlated significantly with the hand dose. CONCLUSION: The median hand dose for different CT-guided interventions was 0.22 mSv. Therefore, the annual hand dose limit would normally only be reached with about 2000 interventions.

[Radiation hygiene in medical X-ray imaging. Part 3: radiation exposure of patients and risk assessment]. / Strahlenhygiene in der medizinischen Röntgenbildgebung : Teil 3: Strahlenexposition des Patienten und Risikobewertung.

The frequency of X-ray examinations in Germany and the resulting radiation exposure is amongst the highest in comparison with other European countries. To reduce medical radiation exposure and to safeguard radiation protection regulations, the X-ray ordinance stipulates a justification of each individual X-ray application. The justification principle means that the X-ray application should produce sufficient health benefit to offset the radiation risk. Such a benefit-risk assessment needs an adequate estimation of radiation risk. The aim of this paper is to explain the principles of benefit-risk assessment for different situations (e.g. healthcare and screening). The basics and concepts of radiation effects and radiation epidemiology as well as examples of risk estimation and benefit-risk assessments are given.

Incidence of leukaemia and other malignant diseases following injections of the short-lived alpha-emitter 224Ra into man.

We performed an epidemiological study on 1,471 ankylosing spondylitis patients treated with repeated intravenous injections of the short lived alpha-emitter (224)Ra (excluding radiation therapy with X-rays) between 1948 and 1975. These patients have been followed together with a control group of 1,324 ankylosing spondylitis patients treated neither with radioactive drugs nor with X-rays. The mean follow-up time was 26.3 years in the exposed and 24.6 years in the control group. To date, causes of death have been ascertained for 1,006 exposed patients and 1,072 controls. Special emphasis was placed on the reporting of malignant diseases. Expected numbers of cases were computed for the age, sex and calendar year distribution of both groups using cancer registry incidence rates. In the exposed group 18 cases of kidney cancer (vs. 9.1 cases expected, P < 0.01) and 4 malignant thyroid tumours (vs. 1.2 cases expected, P = 0.03) were observed. In the control group the observed cases for these tumours were not significantly elevated. The most striking observation, however, were the 21 cases of leukaemia in the exposed group (vs. 6.8 cases expected, P < 0.001) compared to 12 cases of leukaemia in the control group (vs. 7.5 cases expected). Further sub-classification of the leukaemias demonstrated a high increase of myeloid leukaemia in the exposed group (12 cases observed vs. 2.9 cases expected, P < 0.001), and out of these, especially a high excess of acute myeloid leukaemias (7 cases observed vs. 1.8 expected, P = 0.003). In the controls the observed cases are within the expected range (4 myeloid leukaemias vs. 3.1 cases). This increase in total leukaemias as well as particularly in myeloid leukaemias is significant in direct comparison between the exposed and control groups too (P < 0.05). The enhanced leukaemia incidence in the exposed group is in line with the observation of increased leukaemia incidence in mice injected with (224)Ra.

[Nuclear-medical irradiation during pregnancy. Risk assessment for the offspring]. / Nuklearmedizinische Strahlenexpositionen während der Schwangerschaft. Risikoabschätzungen für die Leibesfrucht.

UNLABELLED: AIM To estimate and evaluate the risks for the offspring due to the administration of radiopharmaceuticals to women during the first pregnancy weeks after conception (weeks p.c.). METHODS: The in-utero exposition of the embryo due to diagnostic nuclear medicine procedures, for which diagnostic reference levels (DRL) are specified, as well as due to radio iodine therapy (RIT) was determined. To this end, it is assumed that the activity of the diagnostic radiopharmaceuticals administered to the mother corresponds with the DRL and amounts to 600 MBq or 4 GBq 131I for RIT of benign or malignant thyroid disease, respectively. Based on these data, the radiation risk for the offspring was assessed and compared with the spontaneous risks (R0). RESULTS: The dose for the offspring does not exceed 7.8 mSv for the diagnostic procedures considered, resulting in an excess risk for the offspring of less than 0.12% (R0 approximately 25%) to die from cancer during life, of less than 0.07% (R0 approximately 0.2%) to develop cancer up to the age of 15 years, and of less than 0.16% (R0 approximately 2%) for hereditary effects. RIT during the first 8 weeks p.c. results in doses for the offspring of about 100-460 mSv, resulting in an excess risk for malformations of the child of 3.4%-22% (R0 approximately 6%). CONCLUSIONS: The risk of stochastic radiation effects for the offspring due to a diagnostic nuclear medicine procedure of the mother during the first 8 weeks p.c. is--compared with the spontaneous risks--very small; deterministic effects are unlikely. In contrast, deterministic effects for the offspring may occur following RIT. In order to decide on a possibly indicated abortion after RIT, an individual risk assessment is mandatory.

Increased risk of myeloid leukaemia in patients with ankylosing spondylitis following treatment with radium-224.

OBJECTIVE: To investigate long-term health effects in AS patients treated with (224)Ra. METHODS: A prospective epidemiological study has been carried out on 1471 AS patients treated with repeated intravenous injections of (224)Ra between 1948 and 1975. These patients have been followed together with a control group of 1324 AS patients not treated with radioactive drugs and/or X-rays. Numbers of malignancies expected in a normal population were computed from German and Danish cancer registry data. RESULTS: After a mean follow-up time of 26 yrs in the exposed group or 25 yrs in the control group, causes of death have been ascertained for 1006 exposed patients and 1072 controls. In particular, 19 cases of leukaemia were observed in the exposure group (vs 6.8 cases expected, P < 0.001) compared to 12 cases of leukaemia in the control group (vs 7.5 cases expected). Further subclassification of the leukaemia cases demonstrated a high increase of myeloid leukaemia in the exposure group (11 cases observed vs 2.9 cases expected, P < 0.001), especially a high excess of acute myeloid leukaemias (7 cases observed vs 1.8 cases expected, P = 0.003), whereas in the controls the observed cases are within the expected range (4 myeloid leukaemias vs 3.1 cases expected). CONCLUSIONS: The enhanced leukaemia incidence in the exposed group is in line with results from experiments in mice injected with varying amounts of the bone-seeking alpha-emitter (224)Ra. In these studies, in animals exposed to lower doses of (224)Ra, i.e. at doses lower than those found to induce osteosarcomas, an increased risk of leukaemia was observed.

[Radiation exposure of patients from diagnostic and interventional X-ray procedures. Facts, assessment and trends]. / Strahlenexposition von Patienten durch diagnostische und interventionelle Röntgenanwendungen. Fakten, Bewertung und Trends.

Man-made radiation exposure to the German population predominantly results from the medical use of ionizing radiation. According to the most recent evaluation, the mean effective dose per inhabitant and year from X-ray procedures increased from 1.6 to 1.8 mSv between 1996 and 2001. This rise is mainly caused by the expanding use of CT and reflects the growing importance of this imaging modality. Besides actual data on the frequency and dose of various types of X-ray examinations, patient-specific factors will be highlighted which have to be considered in the assessment of the associated individual and collective radiation risk. Moreover, different concepts to reduce radiation exposure of patients will be discussed as well as some current trends in health service that may affect radiation hygiene -- such as diagnosis-related groups for inpatients and CT screening.

[Introduction of a mammography screening program in Germany. Consideration of benefits and risks]. / Einführung eines Mammographiescreeningprogramms in Deutschland Erwägungen zu Nutzen und Risiko.

For women between 50 and 70 years of age, X-ray mammography presently represents the most effective method for early breast cancer detection. It is commonly accepted that quality assured mammography examinations conducted at regular intervals can reduce mortality from breast cancer. In the year 2002, the German Bundestag agreed to the implementation of a mammography screening program for Germany based on the European guidelines. The effectiveness of a mammography screening program is controversially discussed and two of the most commonly cited hazards are the occurrence of false-positive results and the so-called overdiagnosis. Another issue of criticism is the radiation risk due to the mammography examinations. However, in women aged 50-70 years the radiation risk has no substantial importance. In contrast to the present situation in Germany in which opportunistic screening is widespread, standardized quality assured screening will guarantee that false-positive rates are kept as low as possible and that further assessment diagnostics are effective and minimally invasive.

Lung cancer mortality among nuclear workers of the Mayak facilities in the former Soviet Union. An updated analysis considering smoking as the main confounding factor.

A new analysis of lung cancer mortality in a cohort of male Mayak workers who started their employment in the plutonium and reprocessing plants between 1948 and 1958 has been carried out in terms of a relative risk model. The follow-up has been extended until 1999, moreover a new dosimetry system (DOSES2000) has been established. Particular emphasis has been given to a discrimination of the effects of external gamma-exposure and internal alpha-exposure due to incorporated plutonium. This study has also utilized and incorporated the information from a cohort of Mayak reactor workers, who were exposed only externally to gamma-rays. The influence of smoking as the main confounding factor for lung cancer has been studied. The baseline lung cancer mortality rate was not taken from national statistics but was derived from the cohort itself. The estimated excess relative risk for the plutonium alpha-rays was 0.23/Sv (95%CI: 0.16-0.31). The resulting risk coefficient for external gamma-ray exposure was very low with a statistically insignificant estimate of 0.058/Sv (95%CI: -0.072-0.20). The inferred relative risk for smokers was 16.5 (95%CI: 12.6-20.5).

On the conversion of solid cancer excess relative risk into lifetime attributable risk.

Risk coefficients representing the lifetime radiation-induced cancer mortality (or incidence) attributable to an exposure to ionizing radiation, have been published by major international scientific committees. The calculations involve observations in an exposed population and choices of a standard population (for risk transportation), of suitable numerical models, and of computational techniques. The present lack of a firm convention for these choices makes it difficult to inter-compare risk estimates presented by different scientific bodies. Some issues that relate to a necessary harmonization and standardization of risk estimates are explored here. Computational methods are discussed and, in line with the approach utilized by ICRP, conversion factors from excess relative risk (ERR) to lifetime attributable risk (LAR) are exemplified for exposures at all ages and for occupational exposures. A standard population is specified to illustrate the possibility of a simplified standard for risk transportation computations. It is suggested that a more realistic perception of lifetime risk could be gained by the use of coefficients scaled to the lifetime spontaneous cancer rates in the standard population. The resulting quantity lifetime fractional risk (LFR) is advantageous also because it depends much less on the choice of the reference population than the lifetime attributable risk (LAR).

Childhood leukemia in Belarus before and after the Chernobyl accident: continued follow-up.

Earlier assessments led to the conclusion that due to the added radiation after the Chernobyl accident, childhood leukemia in Belarus was not recognisably increased in the years 1987-1994 compared to the years 1982-1986, i.e. the period before the accident. The present paper gives the data of the continued follow-up (1995-1998) which was conducted by the Institute of Haematology and Blood Transfusion, Minsk. In line with the earlier observations no increase has been identified. The incidence rates have been compared to the data of the newly established Belarussian Childhood Cancer Registry and a tentative explanation is given for apparent differences between the rates from our follow-up and the data reported earlier by the Belarussian Childhood Cancer Registry.

The LNT-controversy and the concept of "controllable dose".

There is no firm scientific information on the potential health effects, such as increased cancer rates, due to low doses of ionizing radiation. In view of this uncertainty ICRP has adopted as a prudent default option the linear no-threshold (LNT) assumption and has used it to derive nominal risk coefficients. Subsequent steps, such as the comparison of putative fatality rates in radiation workers with observed accident rates in other professions, have given the risk estimates a false appearance of scientific fact. This has encouraged meaningless computations of radiation-induced fatalities in large populations and has caused a trend to measure dose limits for the public not against the magnitude of the natural radiation exposure and its geographic variations, but against the numerical risk estimates. In reaction to this development, opposing claims are being made of a threshold in dose for deleterious health effects in humans. In view of the growing polarization, ICRP is now exploring a new concept "controllable dose" that aims to abandon the quantity collective dose, emphasizing, instead, individual dose and, in particular, the control of the maximum individual dose from single sources. Essential features of the new proposal are here examined, and it is concluded that the control of individual dose will still have to be accompanied by the avoidance of unnecessary exposures of large populations, even if their magnitude lies below that acceptable to the individual. If a reasonable cut-off at trivial doses is made, the collective dose can remain useful. Misapplications of collective dose are not the deeper cause of the current controversy; the actual root is the misrepresentation of the LNT-assumption as a scientific fact and the amplification of this confusion by loose terminology. If over-interpretation and distortion are avoided, the current system of radiation protection is workable and essentially sound, and there is no need for a fruitless LNT-controversy. The new concept of controllable dose promises simplifications and improvements, but any major change of principles needs to be carefully considered in a broad discussion that ICRP is presently seeking.

Lung cancer mortality among male nuclear workers of the Mayak facilities in the former Soviet Union.

An analysis of lung cancer mortality in a cohort of 1,669 Mayak workers who started their employment in the plutonium and reprocessing plants between 1948 and 1958 has been carried out in terms of a relative risk model. Particular emphasis has been given to a discrimination of the effects of external gamma-ray exposure and internal alpha-particle exposure due to incorporated plutonium. This study has also used the information from a cohort of 2,172 Mayak reactor workers who were exposed only to external gamma rays. The baseline lung cancer mortality rate has not been taken from national statistics but has been derived from the cohort itself. For both alpha particles and gamma rays, the results of the analysis are consistent with linear dose dependences. The estimated excess relative risk per unit organ dose equivalent in the lung due to the plutonium alpha particles at age 60 equals, according to the present study, 0.6/Sv, with a radiation weighting factor of 20 for alpha particles. The 95% confidence range is 0.39/Sv to 1.0/Sv. For the gamma-ray component, the present analysis suggests an excess relative risk for lung cancer mortality at age 60 of 0.20/Sv, with, however, a large 95% confidence range of-0.04/Sv to 0.69/Sv.

Induction of malignant bone tumors in radium-224 patients: risk estimates based on the improved dosimetry.

Mainly between 1945 and 1955, several thousand German patients with ankylosing spondylitis, tuberculosis, or--in a few cases--other diseases received multiple injections of the short-lived alpha-particle emitter radium-224. In the early 1950s, the follow-up of 899 patients was initiated, and the study has continued since then. It includes most of the high-dose patients and nearly all of those treated as children or juveniles, i.e. under the age of 21. In the study cohort, 56 malignant bone tumors occurred in a temporal wave that peaked 8 years after exposure, whereas less than one case would have been expected during the follow-up. Most of the malignant bone tumors were osteosarcomas and fibrous-histiocytic sarcomas. A new analysis has now been performed, primarily because an improved dosimetry resulted in modified bone surface doses, especially for those treated at younger ages. A significant increase in bone tumor risk with decreasing age at exposure is now demonstrated. The earlier finding of an inverse protraction factor is confirmed. In the new formulation, the dependence on dose rate or duration applies only at higher doses; i.e., the initial slope of the dose dependence is unrelated to dose rate or exposure duration, which is in contrast to earlier analyses but is in agreement with microdosimetric considerations and general radiobiological experience.

Malignancies in patients treated with high doses of radium-224.

Predominantly from 1945 to 1955, a group of patients in Germany was treated with multiple injections of the short-lived alpha-particle emitter (224)Ra. The patients suffered from ankylosing spondylitis, tuberculosis and in a few cases from other diseases. The "Spiess study" (study I) follows up the health of 899 of these patients; it includes most of the patients who were treated with high doses (mean bone surface dose: 30 Gy, mean specific activity: 0.66 MBq/kg), and nearly all of those treated under the age of 21 years. The most striking consequence of the (224)Ra injections was the occurrence of 56 malignant bone tumors. They appeared in a temporal wave that peaked around 8 years after exposure. A new analysis was recently performed, because a reassessment of the dosimetry resulted in changed bone surface doses, especially for the patients treated at younger ages. Averaged over all ages at exposure, the estimated risk coefficient is in general agreement with earlier analyses. However, there is now an increase in bone tumor risk that is significantly greater for younger ages at exposure. The earlier finding of an inverse protraction factor is confirmed. During the most recent years of follow-up, a significant excess of nonskeletal solid malignancies has become manifest. In 1998, a significant increase of breast cancer incidence, of soft tissue malignancies, of thyroid carcinomas, and of liver, kidney and bladder cancer was found. An eightfold increased risk of mammary cancers in those treated at a young age is particularly striking. Equally notable are two cases of breast cancer in male patients. To identify potential confounders, a control group of tuberculosis patients not treated with (224)Ra was established. The comparison confirms that the (224)Ra treatment is responsible for most of the excess of mammary cancer.

Late effects in ankylosing spondylitis patients treated with 224Ra.

This study is comprised of 1577 ankylosing spondylitis patients from 9 German hospitals who have been treated with multiple injections of (224)Ra. The majority of the patients, most of them treated in the years 1948-1975, received one series of 10 weekly intravenous injections of about 1 MBq of (224)Ra each. This dose leads to a mean absorbed dose due to alpha-particle radiation of 0.56 Gy to the marrow-free skeleton of a 70- kg man (mean bone surface dose of about 5 Gy). To provide comparative information on causes of death and on health effects possibly related to the basic disease itself, a control group of 1462 ankylosing spondylitis patients with roughly the same age distribution has been established. By the end of 1998, 649 patients in the exposed group and 762 control patients had died. Among other observations, it is of particular interest that 13 cases of leukemia in the exposed group have been observed. This is a highly significant excess (P < 0.001) compared to a standard population, but only a marginally significant excess in comparison to the seven cases observed in the control group. Subclassification of the leukemias shows a clear preponderance of the myeloid leukemias in the exposed group (8 cases observed compared to 1.7 cases expected, P < 0.001), whereas in the control group the observed cases are within the expected range for myeloid leukemia (3 cases observed compared to 2.2 cases expected, P = 0.3). The (224)Ra cohort of the earlier study (higher-dose group) has provided a risk coefficient that predicts about 8 excess malignant bone tumors for the irradiated cohort in this study. In actuality, 4 cases of malignant tumors in the skeleton have been observed so far. However, excess of breast cancer has not been observed in either the irradiated or the control group, which is in contrast to the findings in the earlier (224)Ra cohort of Study I.

Malignant neoplasms in long-term survivors of bone marrow transplantation. Late Effects Working Party of the European Cooperative Group for Blood and Marrow Transplantation and the European Late Effect Project Group.

BACKGROUND: Patients who receive bone marrow transplants have increased risk for new malignant conditions because of several risk factors, including conditioning with radiation and chemotherapy, immune stimulation, and malignant primary disease. The occurrence of and risk factors for malignant neoplasm in long-term survivors must be assessed. OBJECTIVE: To determine the risk and define potential risk factors for new malignant conditions in long-term survivors after marrow transplantation. DESIGN: Retrospective multicenter study. SETTING: Study of the Late Effects Working Party with 45 transplantation centers cooperating in the European Cooperative Group for Blood and Marrow Transplantation. PATIENTS: 1036 consecutive patients who underwent transplantation for leukemia, lymphoma, inborn diseases of the hematopoietic and immune systems, or severe aplastic anemia. Transplantation was done before December 1985, and patients had survived more than 5 years. MEASUREMENTS: Reports on malignant neoplasms were evaluated, and the incidence was compared to that in the general population. Patient age and sex, primary disease and status at transplantation, histocompatibility of the donor, conditioning regimen, type of prophylaxis of graft-versus-host disease, development of acute and chronic graft-versus-host disease, and treatment of chronic graft-versus-host disease were evaluated as variables. RESULTS: Median follow-up since transplantation was 10.7 years (range, 5 to 22.1 years). Malignant neoplasms were seen in 53 patients; the actuarial incidence (+/- SE) was 3.5% +/- 0.6% at 10 years and 12.8% +/- 2.6% at 15 years. The rate of new malignant disease was 3.8-fold higher than that in an age-matched control population (P < 0.001). The most frequent malignant diseases were neoplasms of the skin (14 patients), oral cavity (7 patients), uterus (including cervix) (5 patients), thyroid gland (5 patients), breast (4 patients), and glial tissue (3 patients). Median age of patients and their donors was 21 years. Malignant neoplasms were more frequent in older patients and in patients with chronic graft-versus-host disease. Older patient age and treatment of chronic graft-versus-host disease with cyclosporine were significant risk factors for new malignant neoplasms after bone marrow transplantation. CONCLUSIONS: The spectrum of neoplasms and immunosuppressive treatment with cyclosporine for chronic graft-versus-host disease as dominant risk factors indicate that immunosuppression is the major cause of malignant neoplasms in patients receiving marrow transplants.

Consideration on a limit for lifetime occupational radiation exposure.

Annual dose limits in occupational radiation exposure are merely a secondary constraint in addition to the primary rule of dose reduction and justification. The limits may, therefore, be reached only in rare, special cases. However, in principle, there might be cases in which the annual limit is continuously exhausted throughout a working life; a high total dose of 0.8 Sv could then be reached. In view of this possibility, there have been considerations of an added restriction by limiting the lifetime occupational dose to 0.4 Sv. The implications of such lifetime doses are considered, and it is shown that an exposure up to the maximum of 0.8 Sv will lead to the need for compensation, if a leukaemia were to occur in the exposed worker. A lifetime dose of 0.4 Sv equally spread over a working life will not lead to the critical value of the probability of causation in excess of 0.5. Nevertheless, it could cause such critical values when it is accumulated during shorter periods. More decisive than the probabilities of causation are, however, the absolute numbers of excess cases of leukaemia due to the occupational exposure. It is seen that less than one excess case would be expected if a group of 100 workers were all exposed to the maximum of 0.8 Sv. Since lifetime doses of 0.8 or 0.4 Sv will be accumulated in very few cases and only with special justification, there appears to be little need to introduce a further limit of lifetime exposure in addition to the current annual limit.

Infant leukemia in Belarus after the Chernobyl accident.

Petridou et al. [1] have reported an increase in infant leukemia in Greek children born between 1/7/86 and 31/12/87 and have linked this increase to in utero radiation exposure due to the Chernobyl accident. Subsequently, Michaelis et al. [2] have reported a similar trend for Germany but found that it was not correlated to the levels of contamination. For Belarus, which was much more severely affected, a similar but much weaker trend is found.