Practical recommendations for the application of DE 59/2013.

The changes introduced with Council Directive 2013/59/Euratom will require European Member States adapt their regulations, procedures and equipment to the new high standards of radiation safety. These new requirements will have an impact, in particular, on the radiology community (including medical physics experts) and on industry. Relevant changes include new definitions, a new dose limit for the eye lens, non-medical imaging exposures, procedures in asymptomatic individuals, the use and regular review of diagnostic reference levels (including interventional procedures), dosimetric information in imaging systems and its transfer to the examination report, new requirements on responsibilities, the registry and analysis of accidental or unintended exposure and population dose evaluation (based on age and gender distribution). Furthermore, the Directive emphasises the need for justification of medical exposure (including asymptomatic individuals), introduces requirements concerning patient information and strengthens those for recording and reporting doses from radiological procedures, the use of diagnostic reference levels, the availability of dose-indicating devices and the improved role and support of the medical physics experts in imaging.

Fortieth Lauriston S. Taylor Lecture: Radiation Protection and Regulatory Science.

It took about 30 y after Wilhelm Konrad Roentgen's discovery of x rays and Henri Becquerel's discovery of natural radioactivity for scientists in the civilized world to formulate recommendations on exposure to ionizing radiation. We know of these efforts today because the organizations that resulted from the concerns raised in 1928 at the Second International Congress of Radiology still play a role in radiation protection. The organizations are known today as the International Commission on Radiological Protection and, in the United States, the National Council on Radiation Protection and Measurements (NCRP). Today, as we have many times in the past, we honor Dr. Lauriston Sale Taylor, the U.S. representative to the 1928 Congress, for his dedication and leadership in the early growth of NCRP. NCRP's mission is "to support radiation protection by providing independent scientific analysis, information, and recommendations that represent the consensus of leading scientists." The developments in science and technology, including radiation protection, are occurring so rapidly that NCRP is challenged to provide its advice and guidance at a faster pace than ever before. NCRP's role has also expanded as the Council considers newer uses and applications of ionizing radiation in research and medicine as well as the response to nuclear or radiological terrorism. In such a technical world, new areas have been established to deal with the nexus of science and regulation, especially in the United States. Lord Ernest Rutherford supposedly said, "That which is not measurable is not science. That which is not physics is stamp collecting." I wonder what he would say if he were alive today as now many embrace a new field called "regulatory science." This term was suggested by Professor Mitsuru Uchiyama in Japan in 1987 and was reviewed in literature published in English in 1996. Some have attributed a similar idea to Dr. Alvin Weinberg, for many years Director of the Oak Ridge National Laboratory. He actually introduced the term "trans-science," which he defined as the policy-relevant fields for which scientists have no answers for many of the questions being asked. He was influenced by the heavy involvement of the Laboratory in developing methods to assess environmental impacts as mandated by the 1969 National Environmental Policy Act. Professor Uchiyama defined regulatory science as "the science of optimizing scientific and technological developments according to objectives geared toward human health." In essence, regulatory science is that science generated to answer political questions. This paper will introduce regulatory science and discuss the differences between what some call "academic science" and "regulatory science." In addition, a short discussion is included of how regulatory science has and will impact the practice of radiation protection and all areas involving the use of radiation and radioactivity.

European activities in radiation protection in medicine.

The recently published Council Directive 2013/59/Euratom ('new European Basic Safety Standards', EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom 'BSS' and the 97/43/Euratom 'Medical Exposure' Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe-these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (non-medical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is launching several actions including promotion and dissemination activities, exchange and discussion fora and provision of guidance. These actions will be based on previous experiences and will rely on the results of recent and ongoing EU-funded projects. Important stakeholders including the Euratom Article 31 Group, the association of the Heads of European Radiological protection Competent Authorities (HERCA) and different European professional and specialty organisations will be involved.

[Control of health risks in radiodiagnosis: a historic approach]. / Controle de riscos a saúde em radiodiagnóstico: uma perspectiva histórica.

This paper presents the history of the discovery of ionizing radiation, as well as its biological effects and the resulting need to control subsequent health risks. It describes the historic evolution of risk control in radiodiagnosis in Brazil, demonstrating that it may be associated not only to the dose received, but also to errors in diagnosis and to costs to the health system. It is stressed that sanitary regulations have a broad remit of social co-responsibility to involve all the players with a view to safeguarding health.

Light water reactor health physics.

In this article an overview of the historical development of light water reactor health physics programs is presented. Operational health physics programs have developed and matured as experience in operating and maintaining light water reactors has been gained. Initial programs grew quickly in both size and complexity with the number and size of nuclear units under construction and in operation. Operational health physics programs evolved to face various challenges confronted by the nuclear industry, increasing the effectiveness of radiological safety measures. Industry improvements in radiological safety performance have resulted in significant decreases in annual collective exposures from a high value of 790 person-rem in 1980 to 117 person-rem per reactor in 2002. Though significant gains have been made, the continued viability of the nuclear power industry is confronted with an aging workforce, as well as the challenges posed by deregulation and the need to maintain operational excellence.

[Compliance with technical standards for radiological protection at radiation therapy services in São Paulo State, Brazil]. / Análise de conformidades às normas técnicas de proteção radiológica dos serviços de radioterapia no Estado de São Paulo, Brasil.

Radiation therapy services provide essential therapeutic procedures for cancer, one of the main causes of population morbidity and mortality. Despite their importance in the health system and their potential risks due to the use of ionizing radiation, there are few studies on such services. We evaluated compliance with technical standards for radiological protection in radiation therapy services in Sao Paulo State, Brazil. Forty-nine services were studied in 2000 through interviews with technical staff. Typologies of performance profiles focusing on structure and process variables were constructed and services compared. Important differences were observed in the services' positions in the health care system, level of complexity, and geographic distribution, with better average performance in structural conditions but very inadequate performance in patient protection, indicating the need for more effective health surveillance.

Light water reactor health physics.

In this article an overview of the historical development of light water reactor health physics programs is presented. Operational health physics programs have developed and matured as experience in operating and maintaining light water reactors has been gained. Initial programs grew quickly in both size and complexity with the number and size of nuclear units under construction and in operation. Operational health physics programs evolved to face various challenges confronted by the nuclear industry, increasing the effectiveness of radiological safety measures. Industry improvements in radiological safety performance have resulted in significant decreases in annual collective exposures from a high value of 790 person-rem in 1980 to 117 person-rem per reactor in 2002. Though significant gains have been made, the continued viability of the nuclear power industry is confronted with an aging workforce, as well as the challenges posed by deregulation and the need to maintain operational excellence.

A radiation litigation causation analysis which achieves fairness to both litigants.

Very few, if any, radiation induced cancers should appear among nuclear workers in the United States. The existing safety standards and lifetime doses received under the operation of those safety standards are such that less than 1% of the cancers that appear in nuclear workers should be related to their occupational radiation exposure. This small numbers of valid claims is a tribute to the effectiveness of the federal safety standards and to the ALARA professional philosophy of achieving excellence in radiation protection which has marked the field of health physics since its inception.

An overview of the current state of radiation litigation.

Over the last three decades, radiation litigation has become a unique field of toxic tort litigation, with many new precedent setting decisions providing guidelines establishing how cases will be litigated in the future. This article will provide a summary of the status of the issues that are being litigated in radiation cases, and suggest recommendations on how pending issues should be resolved in the future.