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.

A review of international and developed practices of medical physics from a legislative and regulatory point of view and its applicability and comparison with Pakistan.

The importance of the medical physics profession and medical physicists is widely recognized by the international bodies like ILO, IAEA, EC, etc. The description of a medical physicist's qualification framework, their role and responsibilities have been addressed in the legislative and regulatory frameworks of developed countries like the USA (in 10CFR) and the EC (EC RP 174) and less comprehensively in developing counties like Pakistan. AFOMP has contributed positively in various regulatory and policy matters regarding the medical physics practices in Asian countries. Furthermore, the recommendations of IAEA's regional meeting on "Medical Physics in Europe-Current Status and Future Perspective" in Vienna, 2015, address the need and mechanism of a harmonized framework for medical physicists' qualifications. The lack of a comprehensive professional recognition framework becomes more challenging when we see that hi-tech diagnostic (e.g. PET CT) and therapeutic (e.g. cyberknife, VMAT, tomotherapy, etc.) modalities are now available in many parts of the world, including Pakistan which still have a basic level of medical physics qualification and practices. Therefore, international efforts like the above-mentioned IAEA-EC meeting in 2015; and by AFOMP activities related to training, qualification and recognition of medical physicists can provide a pathway to further improve medical physics practices in the developing world. The objective of this review is to (i) summarize the international practices for the legislation and regulation of medical physics, (ii) provide a brief overview of the medical physics practices in Pakistan and (iii) discuss the applicability of the IAEA-EC meeting's recommendations to the case of Pakistan. The review highlights the areas which are addressed in IAEA-EC meeting and could be beneficial to other nations as well, particularly, for low and middle income countries. The review also presents few suggestions how to progress with the medical physics profession in developing countries in general, and in Pakistan in particular. These suggestions also include further possible pathway the IAEA could consider, like IAEA project or meetings, to further strengthen the medical physics profession globally.

[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.

AFOMP policy number 6: code of ethics for medical physicists in AFOMP Countries.

This policy statement, which is the sixth of a series of documents prepared by the Asia-Oceania Federation of Organizations for Medical Physics (AFOMP) Professional Development Committee, gives guidance on how medical physicists in AFOMP countries should conduct themselves in an ethical manner in their professional practice (Ng et al. in Australas Phys Eng Sci Med 32:175-179, 2009; Round et al. in Australas Phys Eng Sci Med 33:7-10, 2010; Round et al. in Australas Phys Eng Sci Med 34:303-307, 2011; Round et al. in Australas Phys Eng Sci Med 35:393-398, 2012; Round et al. in Australas Phys Eng Sci Med 38:217-221, 2015). It was developed after the ethics policies and codes of conducts of several medical physics societies and other professional organisations were studied. The policy was adopted at the Annual General Meeting of AFOMP held in Jaipur, India, in November 2017.

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.

Changing Roles of State Health Physicists.

State radiation control programs are responsible for many aspects of radiation protection under their purview. These may include all aspects of radiation protection for sources of radiation not exclusively under federal control under an agreement with the U.S. Nuclear Regulatory Commission and the use of some sources of radiation not regulated by the federal government, such as radiation machines and naturally occurring radioactive material. The roles of state health physicists are ever-evolving, and the scope of their work is constantly expanding. This has come about most recently due to several factors, including additional federal requirements involving source security, emerging radiation machine technologies, expansion of emergency planning to include terrorist incidents, and more states with issues involving technologically enhanced naturally occurring radioactive material. These changes in the role of state health physicists and the new challenges are adding to the need for health physics resources and knowledge base. Several approaches are being used to address the training needs and technological and regulatory challenges, but these will continue to be needed to meet future workforce needs.

Meeting Regulatory Needs.

The world is experiencing change at an unprecedented pace, as reflected in social, cultural, economic, political, and technological advances around the globe. Regulatory agencies, like the U.S. Nuclear Regulatory Commission (NRC), must also transform in response to and in preparation for these changes. In 2014, the NRC staff commenced Project Aim 2020 to transform the agency by enhancing efficiency, agility, and responsiveness, while accomplishing NRC's safety and security mission. Following Commission review and approval in 2015, the NRC began implementing the approved strategies, including strategic workforce planning to provide confidence that NRC will have employees with the right skills and talents at the right time to accomplish the agency's mission. Based on the work conducted so far, ensuring an adequate pipeline of radiation protection professionals is a significant need that NRC shares with states and other government agencies, private industry, academia, as well as international counterparts. NRC is working to ensure that sufficient radiation protection professionals will be available to fulfill its safety and security mission and leverage the work of the National Council on Radiation Protection and Measurements, the Conference of Radiation Control Program Directors, the Health Physics Society, the Organization of Agreement States, the International Atomic Energy Agency, the Nuclear Energy Agency, and others.

The European Federation of Organisations for Medical Physics Policy Statement No. 6.1: Recommended Guidelines on National Registration Schemes for Medical Physicists.

This EFOMP Policy Statement is an update of Policy Statement No. 6 first published in 1994. The present version takes into account the European Union Parliament and Council Directive 2013/55/EU that amends Directive 2005/36/EU on the recognition of professional qualifications and the European Union Council Directive 2013/59/EURATOM laying down the basic safety standards for protection against the dangers arising from exposure to ionising radiation. The European Commission Radiation Protection Report No. 174, Guidelines on Medical Physics Expert and the EFOMP Policy Statement No. 12.1, Recommendations on Medical Physics Education and Training in Europe 2014, are also taken into consideration. The EFOMP National Member Organisations are encouraged to update their Medical Physics registration schemes where these exist or to develop registration schemes taking into account the present version of this EFOMP Policy Statement (Policy Statement No. 6.1"Recommended Guidelines on National Registration Schemes for Medical Physicists").

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.

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.

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.

A litigation primer for the health physicist.

This primer presents a basic overview of legal terminology and theories that may be encountered by the health physicist relative to radiation-related litigation. Legal terms are defined, and the progression of a sample radiation injury claim is explained from the filing of a claim through the appeal process. The objective of the primer is to establish a basic foundation of legal concepts on which to build further understanding. The legal system is an arena with which most health physicists have essentially no familiarity or, at best, limited knowledge. The chances are increasing that health physics professionals may be involved in radiation injury litigation in some way, requiring a basic understanding of these concepts.

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.

Documentation and log keeping: ensuring your work does what you intend it to do.

Maintaining regular documentation, such as a log-book, can be an organization's most important asset when dealing with radiation protection issues, both normal and abnormal. When an organization is faced with litigation, proper documentation of events can ensure that a record is acceptable and, by extension, that the data itself is acceptable. A record of events will not preclude litigation, nor will it guarantee that an organization will prevail in a court of law, but it will provide evidence and credibility that could favorably affect the outcome of litigation. An organization can ensure that the documents it creates and maintains are as effective as possible by being aware of the legal consequences of documenting events and taking appropriate steps to conform to standards for admission of documentation. Misconceptions about log keeping such as recording only events that are likely to result in litigation, rather than recording all events, can prevent a record from being admissible as evidence. Because of the amount of effort and time put into documentation, and the reliance placed on its contents, it is important for an organization to ensure that a record will do what it is intended to do, namely to accurately record activities. Issues discussed in this article include the legal basis of documentary evidence, what and what not to record, when and how to record it, and how to strengthen the records kept.

The role of the expert witness: an update.

As in the past, the principle role of the scientist in the courtroom is to assist attorneys, judges, and jurors in understanding the complex scientific and technical issues before them. In the last decade, however, changes in the law and the increasing technical complexity of many disputes have introduced new factors that influence the preparation and presentation of expert testimony. The most significant change in the law regarding expert testimony is arguably the 1993 Supreme Court ruling in Daubert vs. Merrell Dow Pharmaceuticals. Under Daubert, scientific evidence may be submitted to the jury if the judge finds that it rests on a reliable foundation and is relevant to the task at hand. Reliability and relevance replace the older requirement of "general acceptance by the scientific community," although "general acceptance" remains a factor in the consideration of reliability. The tests of reliability and relevance and their impact on the preparation of expert opinions are discussed in the context of increasingly complex radiation cases, with emphasis on cases involving teams of experts.

Notices of violation issued to Texas radioactive material licensees inspected in 1995.

Notices of violation stemming from the inspection activities of the Texas Department of Health's Bureau of Radiation Control during calendar year 1995 are summarized and characterized. Although eight distinct general categories of radioactive material licenses were included in the analysis, certain general trends were noted, permitting the formulation of an objective list of the ten most frequent violations cited. In order ranked from the most frequent, these include not following operating or safety procedures, radiation surveys not being performed, inadequate personnel monitoring records, instrumentation not used or out of calibration, radioactive material inventories not performed, leak tests not performed, deficiencies in training for industrial uses, inadequate inspection and maintenance of devices, unauthorized users of radioactive material, and incomplete or absent records for receipt or transfer of radioactive material. Although the analysis was limited to a single state, the results can benefit radiation protection quality assurance programs and health physics continuing education efforts by objectively identifying areas commonly cited for being deficient. The results also reiterate the necessity for proper documentation, as at least seven of the ten most frequent violations issued appear to stem predominantly from the records of radiation protection programs.

Reflections on the benefits of participating in ACURI.

There are many benefits to participating in the activities of a low-level radioactive waste generators group. Among them are the sharing of ideas, experience, and successes; ready access to information on all aspects of radioactive waste disposal; and the ability to have input into the regulatory and decision making processes.