Society and Nuclear Energy: What Is the Role for Radiological Protection?

ABSTRACT: The harm that society expects from ionizing radiation does not match experience. Evidently there is some basic error in this assumption. A reconsideration based on scientific principles shows how simple misunderstandings have exaggerated dangers. The consequences for society are far-reaching. The immediate impact of ionizing radiation on living tissue is destructive. However, this oxidative damage is similar to that produced during normal metabolic activity where the subsequent biological reaction is not only protective but also stimulates enhanced protection. This adaptation means that the response to oxidative damage depends on past experience. Similarly, social reaction to a radiological accident depends on the regulations and attitudes generated by the perception of previous instances. These shape whether nuclear technology and ionizing radiation are viewed as beneficial or as matters to avoid. Evidence of the spurious damage to society caused by such persistent fear in the second half of the 20 th century suggests that these laws and attitudes should be rebased on evidence. The three stages of radiological impact-the initial physical damage, the subsequent biological response, and the personal and social reaction-call on quite different logic and understanding. When these are confused, they lead to regulations and public policy decisions that are often inept, dangerous, and expensive. One example is when the mathematical rigor of physics, appropriate to the immediate impact, is misapplied to the adaptive behavior of biology. Another, the tortured historical reputation of nuclear technology, is misinterpreted as justifying a radiological protection policy of extreme caution.Specialized education and closed groups of experts tend to lock in interdisciplinary misperceptions. In the case of nuclear technology, the resulting lack of independent political confidence endangers the adoption of nuclear power as the replacement for fossil fuels. In the long term, nuclear energy is the only viable source of large-scale primary energy, but this requires a re-working of public understanding.

Science-informed Policy Making for Protecting People and the Environment from Radiation.

ABSTRACT: The process to arrive at the radiation protection practices of today to protect workers, patients, and the public, including sensitive populations, has been a long and deliberative one. This paper presents an overview of the US Environmental Protection Agency's (US EPA) responsibility in protecting human health and the environment from unnecessary exposure to radiation. The origins of this responsibility can be traced back to early efforts, a century ago, to protect workers from x rays and radium. The system of radiation protection we employ today is robust and informed by the latest scientific consensus. It has helped reduce or eliminate unnecessary exposures to workers, patients, and the public while enabling the safe and beneficial uses of radiation and radioactive material in diverse areas such as energy, medicine, research, and space exploration. Periodic reviews and analyses of research on health effects of radiation by scientific bodies such as the National Academy of Sciences, National Council on Radiation Protection and Measurements, United Nations Scientific Committee on the Effects of Atomic Radiation, and the International Commission on Radiological Protection continue to inform radiation protection practices while new scientific information is gathered. As a public health agency, US EPA is keenly interested in research findings that can better elucidate the effects of exposure to low doses and low dose rates of radiation as applicable to protection of diverse populations from various sources of exposure. Professional organizations such as the Health Physics Society can provide radiation protection practitioners with continuing education programs on the state of the science and describe the key underpinnings of the system of radiological protection. Such efforts will help equip and prepare radiation protection professionals to more effectively communicate radiation health information with their stakeholders.

The Impact of the Linear No-threshold Hypothesis on Litigation.

ABSTRACT: As the basis of radiation safety practice and regulations worldwide, the linear no-threshold (LNT) hypothesis exerts enormous influence throughout society. This includes our judicial system, where frivolous lawsuits are filed alleging radiation-induced health effects caused by negligent companies who subject unwitting victims to enormous financial and physical harm. Typically, despite the lack of any supporting scientific basis, these cases result in enormous costs to organizations, insurance companies, and consumers.

Radiation therapy: Regulatory framework and constraints.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France.

The internal dosimetry user group position statement on molecular radiotherapy.

The Internal Dosimetry User Group (IDUG) is an independent, non-profit group of medical professionals dedicated to the promotion of dosimetry in molecular radiotherapy (www.IDUG.org.uk). The Ionising Radiation (Medical Exposure) Regulations 2017, IR(ME)R, stipulate a requirement for optimisation and verification of molecular radiotherapy treatments, ensuring doses to non-target organs are as low as reasonably practicable. For many molecular radiotherapy treatments currently undertaken within the UK, this requirement is not being fully met. The growth of this field is such that we risk digressing further from IR(ME)R compliance potentially delivering suboptimal therapies that are not in the best interest of our patients. For this purpose, IDUG proposes ten points of action to aid in the successful implementation of this legislation. We urge stakeholders to support these proposals and ensure national provision is sufficient to meet the criteria necessary for compliance, and for the future advancement of molecular radiotherapy within the UK.

The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.

The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.

Optimization of the scan length of head traumas on the pediatric and adult CT scan and proposition of a new acquisition limit.

To propose a new method of reducing the scan length of head trauma while keeping the diagnostic efficiency of the examination in order to develop DRL in an African context. This is a retrospective single-center study including 145 patients who had cranial examinations on a 64-barettes scanner. All head trauma cases were selected. The interpretations of these CT scanners by the three radiologists of the service were noted to determine the acquisition limit. All patient acquisition lengths have been recorded. The acquisition limit for head trauma ended in clinical routine at cervical spine 4 (C4). The average scan length was 23.03 cm. Out of the CT scan results for 145 patients, only 2 (1.37%) had a C3 level cervical spine fracture and 2 (1.37%) at C4. By respecting the principles of radiation protection, this result has shown us that it is possible to limit the acquisition length of the CT scanners indicated for head trauma. The limit of the optimized scan length that we proposed is at cervical spine 2 (98.62%). Now, all head trauma are limited on cervical vertebra 2 in our hospital. The use of this new method is beneficial when the clinical indication of the examination and the type of trauma (multi-trauma) are taken into account. Based on the principles of radiation protection and the clinical indication for the examination, reducing the scan length from C4 to C2 is an effective way to reduce the dose absorbed by the patient.

Trend of strengthening clearance regulation in Japan and concerns about its worldwide effects on regulations for natural and artificial radionuclides.

The Nuclear Regulation Authority (NRA) of Japan invited comments from the public on a revised guide on measurement and evaluation for clearance in 2019, which included a strict decision on how to treat uncertainties in the measurement and the nuclide vector. To resolve the issue on the uncertainty in clearance, a probabilistic approach had been established previously in the Atomic Energy Society of Japan Standard and incorporated into International Atomic Energy Agency (IAEA) Safety Report No. 67. NRA's new decision on the uncertainty in clearance was up to 10 times stricter than the probabilistic approach. This issue has been discussed at an international level in the framework of the ongoing revision of IAEA Safety Guide RS-G-1.7. This discussion on the uncertainty in clearance has raised serious concerns about its effects on other radiological protection regulations worldwide. This is because if we need strict treatment for the uncertainty in clearance, the same or even stricter treatment for conformity assessment may have to be applied to other radiological protection criteria for doses exceeding 10 µSv year-1. Radiological protection experts including regulators, professionals, and operators should be aware of the essential meaning of the radiological protection criteria by considering the background scientific basis on which they were established.

Investigation of radiation protection and safety measures in Rwandan public hospitals: Readiness for the implementation of the new regulations.

BACKGROUND: An essential concept that all radiographers are required to implement is the use of techniques and the provision of protective devices to minimize radiation to patients and staff. Methods to achieve this could include good communication, immobilization, beam limitation, justification for radiation exposure, shielding, appropriate distances and optimum radiographic exposures factors. PURPOSE: The aim of this study was to assess the availability and utilization of radiation protection and safety measures by medical imaging technologists (MITs) in Rwandan hospitals. METHODS: A quantitative, non-experimental descriptive design was used and data collected by means of a self-designed questionnaire. One hundred and sixteen MITs (n = 116) representing 96.67% of the total population participated in the study. RESULTS: The study found radiation safety measures were not adequately implemented in government hospitals. Only 58.62% of MITs had radiation-measuring devices, with 29% receiving dose readings inconsistently. Lead rubber aprons were available at 99.13% of the hospitals; however, 59% of the participants had never checked the integrity of the aprons. Lead rubber aprons and lead equivalent barriers were most prevalent in the facilities. CONCLUSION: The study found there was a lack of adequate radiation safety equipment. Exposure charts and immobilization devices were not adequately implemented in the hospitals. The level of education and experience of the MITs did not appear to influence the radiation safety practice significantly. There is a need for concerted efforts between the Rwanda Utilities Regulatory Authority (RURA), Ministry of Health, University of Rwanda and hospital management to improve the radiation safety culture, especially in view of the law governing radiation protection that was recently promulgated.

[The new radiation protection legislation-part 2 : Modifications in radiology regarding approval procedure and special fields including teleradiology]. / Die neue Strahlenschutzgesetzgebung ­ Teil 2 : Änderungen in der Radiologie bezüglich Vorabkontrolle und Sonderbereiche, einschließlich Teleradiologie.

BACKGROUND: The entry of the new Radiation Protection Act and new Radiation Protection Regulation into force in Germany created many changes for radiology with regard to the old Radiation Protection Regulation and X­ray Regulation. OBJECTIVES: The substantial modifications in radiology regarding the areas of approval and notification procedures, teleradiology, screening, research and radon in the workplace are summarized. METHOD: Changes in the new Radiation Protection Act and Regulation compared to the old Radiation Protection Regulation and X­ray Regulation were evaluated. Thereby, the focus was on areas beyond the workflow in clinical routine. RESULTS AND CONCLUSION: The requirements for the approval and notification procedure have increased. For example, proof must be provided that a medical physics expert can be consulted. The establishment of deadlines for the process by the responsible authorities may accelerate the procedure and create planning certainty.

[The new radiation protection legislation-part 1 : Modifications in radiology for the workflow in clinical routine]. / Die neue Strahlenschutzgesetzgebung ­ Teil 1 : Änderungen für die arbeitstägliche Routine in der Radiologie.

BACKGROUND: On 31 December 2018, the new Radiation Protection Regulation came into effect in Germany and made the new Radiation Protection Act more concrete. The old Radiation Protection Regulation and X­ray Regulation have thereby been replaced. OBJECTIVES: The substantial modifications regarding the practical daily routine in radiology are summarized. METHODS: Modifications and innovations of the New Radiation Protection Act and Regulation compared to the old Radiation Protection Regulation and X­ray Regulation and accordances were evaluated. Thereby the main focus was in the relevance for workflow in clinical routine. RESULTS AND CONCLUSION: The new legislation contains a number of regulations that provide crucial tools for implementation of radiation protection, quality assurance, and dose optimization. However, this also requires additional time and personnel.

The new radiation protection framework since 2019 - Implementation in Germany and comparison of some aspects in seven European countries. / Das neue Strahlenschutzrecht ab 2019 ­ Umsetzung in Deutschland und Vergleich einzelner Aspekte in 7 europäischen Ländern.

PURPOSE: The implementation of EU Directive 2013/59 EURATOM (EU-BSS) of 2014 led to a reorganization of radiation protection legislation in Germany in the form of a new radiation protection law Strahlenschutzgesetz (StrlSchG) of 2017 and a new radiation protection ordinance Strahlenschutzverordnung (StrlSchV) of 2018. For application of ionizing radiation in medicine these changes affect radiology, nuclear medicine and radiotherapy. A comparison between the old and the new legal system analyses changes that are relevant for diagnostic and interventional radiology. For the important new regulation of unintended exposures, a comparison is made with the implementation of Art. 63 EU-BSS in 7 European countries. MATERIAL AND METHODS: The provisions of the Röntgenverordnung (RöV) and the old Strahlenschutzverordnung (StrlSchV alt), which were valid until 2018, are compared with the new legislation of StrlSchG and StrlSchV for changes in radiation protection for patients, the population and occupational radiation protection of staff members. The occupational dose limit of the eye lens was reduced. The reduction by a factor of 7.5 results in new requirements for radiation protection equipment. New requirements in teleradiology are compared with the previous regulation, as well as the necessary involvement of medical physics experts (MPE) in high dose procedures, such as CT and fluoroscopic interventions. The regulation for unintended exposures of the German StrlSchV are analyzed in terms of their reporting criteria. RESULTS: The principles of medical radiation protection in Germany have not changed as a result of the new radiation protection legislation from 2019 onwards. However, there are a number of changes and new requirements that must be considered and implemented. Important points are e. g. new regulations on teleradiology, early detection of diseases in asymptomatic individuals and reporting of unintended exposure of patients. As all new regulations are no longer found in only one single regulation, both knowledge of the StrlSchG and the StrlSchV are necessary. KEY POINTS: · The EU Directive 2013/59 EURATOM (EU-BSS) was transposed into the new German radiation protection law 2018. · The basic regulations of the RöV and old StrlSchV remain unchanged. · Newly added regulations must be known and implemented in practice. · Many regulations of the EU-BSS are so vaguely formulated that they allow a wide scope for national implementation. CITATION FORMAT: · Loose R, Wucherer M, Walz M et al. The new radiation protection framework since 2019 - Implementation in Germany and comparison of some aspects in seven European countries. Fortschr Röntgenstr 2020; 192: 1036 - 1045.

Assessing radiation protection knowledge in diagnostic radiography in the Republic of Cyprus. A questionnaire survey.

INTRODUCTION: Radiation protection knowledge is essential for medical personnel in ensuring that the possible risks do not outweigh the benefits of diagnostic imaging. This study aimed to assess the radiation protection knowledge of radiographers in Cyprus. METHODS: A cross-sectional study was carried out among radiographers in Cyprus through the Cyprus Society of Registered Radiologic Technologists & Radiation Therapy Technologists. The study was a quantitative descriptive analysis, using a questionnaire with 22 multiple-choice questions. Analysis of the data was done using the statistical software Stata, by performing mean knowledge score comparisons by different participants' characteristics, using t-test and analysis of variance test. Statistical significance was assumed as a p-value < 0.05. RESULTS: The answers provided for each question indicate that some areas of radiation protection are less known compared to others, as there is quite a wide range of correct-to-incorrect ratios. The analysis based on participant characteristics in relation to overall radiation effects knowledge, identified important determinants, namely the workplace of the participant (p = 0.006), the type of work licence the participant held at the time of the questionnaire (p = 0.024), and the years of clinical experience of the participant (p = 0.021). CONCLUSION: The study showed that the levels of knowledge in radiation protection are of a very good standard. However, work is needed to clarify the specifics of dose limits and the national radiation protection legislation with regards to informing patients about the possible effects of ionising radiation. IMPLICATIONS FOR PRACTICE: The study results indicate the importance of educating radiographers about the requirements of national radiation protection legislation and how this new knowledge can be linked with practise.

Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example. / Früherkennung von Krankheiten mittels radiologischer Bildgebung: Neue Rechtslage und Bewertung von Leistungsangeboten am Beispiel von CT-Untersuchungen.

BACKGROUND: Radiological imaging offers promising prospects for the early detection of diseases. In Germany, the legal framework for such examinations was created by the Radiation Protection Law, which entered into force on December 31, 2018. Under this law, each specific type of radiodiagnostic screening of non-communicable diseases needs an approval on a generic level (permission) by a federal statutory ordinance, defining the specific requirements and conditions. It is the aim of the present paper, (i) to present in detail the new legal situation and (ii) to assess actual service offers for the screening of asymptomatic persons using CT examinations as an example. METHOD: In February 2019, radiology institutions in Germany illegally offering on the Internet CT examinations for the screening of lung and colon cancer or coronary artery disease were identified. For each type of examination, 50 pertinent websites were evaluated particularly regarding the general information on the offered screening examination and the concrete procedure. RESULTS: In the vast majority of cases, the information provided on the websites was inadequate and disproportionately emphasized the benefits over the risks of the screening examination. Moreover, the offers differed substantially with respect to the age and risks factors of potential participants, the frequency of examinations, the screening procedure, and the diagnostic workup. CONCLUSION: The evaluated service offers strongly substantiate the need to define requirements and conditions regarding radiological screening examinations by statutory ordinances, in order to ensure an informed decision of potential screening participants as well as the benefit versus the risks of the procedures. KEY POINTS: · High-evidence studies prove the benefit of radiological screening for some diseases.. · In Germany, screening examinations are only permissible when stated in a federal statutory ordinance.. · At present, only mammography screening for breast cancer is permitted in Germany.. · CT screening examinations currently being conducted in Germany do not fulfill the legal and professional requirements.. · A review process has been initiated regarding possible generic approval of lung cancer screening.. CITATION FORMAT: · Brix G, Nekolla EA, Griebel J. Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example. Fortschr Röntgenstr 2020; 192: 139 - 148.

Use of Routine Environmental Monitoring Data to Establish a Dose-based Compliance System for a Low-level Radioactive Waste Disposal Site.

A dose-based compliance methodology was developed for Waste Control Specialists, LLC, low-level radioactive waste facility in Andrews, Texas, that allows routine environmental measurement data to be evaluated not only at the end of a year to determine regulatory compliance, but also throughout the year as new data become available, providing a continuous assessment of the facility. The first step in the methodology is a screening step to determine the potential presence of site emissions in the environment, and screening levels are established for each environmental media sampled. The screening accounts for spatial variations observed in background for soil and temporal fluctuations observed in background for air. For groundwater, the natural activity concentrations in groundwater wells at the facility are highly variable, and therefore the methodology uses ratios for screening levels. The methodology compares the ratio of gross alpha to U + U to identify potentially abnormal alpha activity and the ratio of U to U to identify the potential presence of depleted uranium. Compliance evaluation is conducted for any samples that fail the screening step. Compliance evaluation uses the radionuclide-specific measurements to first determine (1) if the dose exceeds the background dose and if so, (2) the dose consequences, so that the appropriate investigation or action occurs. The compliance evaluation is applied to all environmental samples throughout the year and on an annual basis to determine regulatory compliance. The methodology is implemented in a cloud-based software application that is also made accessible to the regulator. The benefits of the methodology over the existing system are presented.

COMP Report: A survey of radiation safety regulations for medical imaging x-ray equipment in Canada.

X-ray regulations and room design methodology vary widely across Canada. The Canadian Organization of Medical Physicists (COMP) conducted a survey in 2016/2017 to provide a useful snapshot of existing variations in rules and methodologies for human patient medical imaging facilities. Some jurisdictions no longer have radiation safety regulatory requirements and COMP is concerned that lack of regulatory oversight might erode safe practices. Harmonized standards will facilitate oversight that will ensure continued attention is given to public safety and to control workplace exposure. COMP encourages all Canadian jurisdictions to adopt the dose limits and constraints outlined in Health Canada Safety Code 35 with the codicil that the design standards be updated to those outlined in NCRP 147 and BIR 2012.