Safety Assessment Principles Research Articles

Towards system-theoretic risk management for maritime transportation systems: A case study of the yangtze river estuary

This paper presents a novel framework for system-theoretic risk management of maritime transportation systems (MTS) based on the principles of formal safety assessment. The proposed framework comprises four essential steps: (1) risk identification: identifying accident scenarios and associated risk-influencing factors in the MTS through text mining of maritime accident investigation reports; (2) risk analysis: determining the probabilities and consequences of accident scenarios in the MTS using Bayesian network modeling; (3) risk evaluation: assessing the risks of various accident scenarios and the comprehensive risk of the MTS, and comparing the results with risk acceptance criteria to make informed decisions; and (4) risk treatment: proposing effective risk control options (RCOs) for accident scenarios and the comprehensive risk of the MTS by incorporating expert judgment, fuzzy sets, and Bayesian network modeling. To demonstrate the applicability of the proposed framework, the risk management of the Yangtze River Estuary is presented as a case study. By adopting a comprehensive approach to risk management, stakeholders gain a more holistic view of risk and achieve more effective decision-making processes for RCOs. The framework may help improve the safety and security of maritime operations, enhance the efficiency and competitiveness of the industry.

Rail and road infrastructure: cross-modal safety risk evaluation and assessment principles

We explore the similarities and differences between the governing Risk Evaluation and Assessment (REA) principles for rail and road infrastructure. We frame our analysis with infrastructure managers in mind. In England, Network Rail and National Highways are the key rail and road infrastructure managers, respectively. The intention is to demonstrate that seemingly unrelated rail and road infrastructure upgrade projects are not that different – at least from the REA point of view. By breaking the potential REA barriers between the two modes, a number of benefits can be realised across the project lifecycle and beyond. Safely allowing the space for future change and innovation is a key guiding principle. Our findings point towards ‘systems thinking’ where rail and road can be approached as a single system – at least from the REA activities point of view. At a project level, this means that there are potentially many unexplored synergies between the two sectors. This may not only be in terms of safety, but also in terms of managing capital expenditure and operational expenditure and efficiencies. Future work would concentrate on drawing parallels between rail and road REA approaches for operating companies (and vehicles) to support our ‘Systems Thinking’ vision.

Designing and implementing temporary works schemes on UK nuclear licensed sites

Nuclear projects in the UK demand high levels of assurance and substantiation during both design and construction. As a result, site licensees must demonstrate control over construction works in the vicinity of, or modifications to safety-related structures, systems and components in accordance with their nuclear site licence conditions. Furthermore, the Office for Nuclear Regulation will scrutinise designs, management controls and processes prior to permissioning the works. This paper discusses examples of additional considerations for the design and implementation of temporary works during the construction phase to demonstrate compliance with the regulators, Safety Assessment Principles and licence conditions, and to demonstrate that nuclear safety risks have been reduced to as low as reasonably practicable. References of good practice are from a confidential BAE Systems project in Cumbria, UK, titled D58, involving nuclear Class 1 concrete construction and informing of the steps taken to obtain Nuclear Safety Committee and regulatory permissioning.

Assessing the food safety risk of ochratoxin A in coffee: A toxicology-based approach to food safety planning.

Under the Food Safety Modernization Act (FSMA) and preventive controls (PCs) regulations, food manufacturers must consider whether PCs are needed for potential hazards present in food. The mycotoxin ochratoxin A (OTA) is considered a chemical hazard under FSMA. It is produced by several fungal species and can be present in various agricultural commodities, including coffee. OTA presents a unique scenario in food safety, because it is known to be a potential risk; because heating may destroy it, but not completely; and because the hazard profile suggests it is not acutely toxic at the occurrence levels in coffee, although at high exposure levels, it is potentially nephrotoxic and carcinogenic in animal models. In the absence of US compliance levels, it is important for the risk assessor and risk manager to determine whether PCs are warranted. To address this complex situation in the coffee industry, we combined food safety and toxicology risk assessment principles to examine the available information on OTA hazard and risk in coffee. Exposure and health-based benchmarks for OTA in coffee, established by reviewing peer-reviewed literature, food recall databases, and authoritative reviews, resulted in large margins-of-exposure for both single and repeated exposure scenarios. Furthermore, no evidence was identified from historical data to suggest OTA is acutely toxic in humans from coffee consumption or other exposure sources. Therefore, findings from this assessment indicate that no PC is warranted for US coffee manufactures, based on the low severity and likelihood of risk according to margin-of-exposure estimates and historical data.

Transient Analysis and Safety Assessment of Turbofan Engine Structures during Bird Ingestion

The high bypass ratio turbofan engine’s load-carrying structure transient response during bird ingestion was analyzed in accordance with the engine bird ingestion certification regulations, the principles of structural safety assessment were represented, and the structural safety analysis and assessment method of Turbo-Fan engine during bird ingestion were proposed. A high bypass ratio turbofan engine’s FEM was established and verified the rationality when its’ operation. Large bird ingestion into an engine’s procedure was conducted, the dynamic responses of key components on engine’s load-carrying structures during the bird ingestion were discussed, and the safety assessment consequence was obtained. We draw a conclusion that the relevant analysis/simulation data could be submitted to engine certification administration as key documents, the structural safety analysis and assessment method of turbofan engine due to bird ingestion could be applied as analysis and prediction work in the engine bird ingestion certification.

A study on current risk assessments and guidelines on the use of food animal products derived from cloned animals

The author widely surveyed and analyzed the food safety issues, ethical issues, permits, and approval of animal products from animals cloned by somatic cell nuclear transfer worldwide. As a result of a 2-year survey, the author found that there is no evidence that meat and milk derived from cloned animals or their progeny pose a risk to food safety in terms of genotoxicity, adverse reproductive effects, or allergic reactions. Most countries have not approved meat and milk derived from cloned animals, and their progeny are entering the food supply. To establish the guidelines, the author suggests four principles of safety assessment for meat and milk derived from cloned animals. The four main principles for safety assessment are similarities of chemical composition, adverse reproductive effects, genotoxicity, and allergic reactions under the influence of meat and milk from cloned animals and noncloned counterparts. This principle means that meat and milk derived from a cloned animal are safe if there are no differences in the four safety assessments of meat and milk between cloned animal's progeny and noncloned counterparts.

Principles of Efficiency and Safety Assessment in Using Exoskeletons for Patients with Lower Limb Paralyses (Review)

Principles of Efficiency and Safety Assessment in Using Exoskeletons for Patients with Lower Limb Paralyses (Review)

Practical experience of failure analysis on nuclear facility or how I learned to love a well-structured FMEA

The safety assessment principles for nuclear facilities, produced by the Office for Nuclear Regulation (ONR), define Engineering Principles which require a formal and structured analysis to be undertaken to identify all potential failure modes for structures, systems and components important to safety within a nuclear facility.It has been widely publicised, for example in “Mitigating the Loss of Critical Knowledge” by Bell (2014), that there is a skills shortage in engineering design assurance in highly regulated industries within the UK. This paper presents examples and lessons learnt from 5 years of practical experience in performing structured failure analysis, particularly Failure, Modes and Effects Analysis (FMEA), on nuclear facility design: these lessons learnt are considered applicable to all highly regulated industries. It is hoped that the following examples included in this report, might inspire and guide others in the development of FMEA in support of design assurance activities:Tailoring the level at which FMEA is undertaken to the nuclear classification of the safety function; detailed component level FMEA for higher level safety functions, and high level functional FMEA for lower level safety functions;Running the FMEA in parallel with design development and working with the design engineers to ensure results from the FMEA can influence the design at the appropriate time;Using FMEA to identify design mitigation and Examination, Maintenance, Inspection and Test (EMIT) recommendations during early phases of the design;Using FMEA to identify redundancy within a design to reduce the maintenance burden through life;Inclusion of component failure mode failure rate data to calculate the Probability of Failure on Demand (PFD) of safety functions;Inclusion of dependability analysis between systems to calculate the PFD of a higher level function;The positive impact of integrating Human Factors (HF) assessors in the development of the failure analysis.

Symposium on safety and risk-assessment approaches for materials of herbal origin: Managing editor′s remarks

Symposium on safety and risk-assessment approaches for materials of herbal origin: Managing editor′s remarks

HSE’s safety assessment principles for criticality safety

The Health and Safety Executive (HSE) published its revised Safety Assessment Principlesfor Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for useby HSE’s inspectors when judging the adequacy of safety cases for nuclear facilities.The revised SAPs relate to all aspects of safety in nuclear facilities including thetechnical discipline of criticality safety. The purpose of this paper is to set out forthe benefit of a wider audience some of the thinking behind the final publishedwords and to provide an insight into the development of UK regulatory guidance.The paper notes that it is HSE’s intention that the Safety Assessment Principlesshould be viewed as a reflection of good practice in the context of interpretingprimary legislation such as the requirements under site licence conditions forarrangements for producing an adequate safety case and for producing a suitableand sufficient risk assessment under the Ionising Radiations Regulations 1999(SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf).

HSE’s Safety Assessment Principles for radiation protection

The Health and Safety Executive (HSE) published its revised Safety Assessment Principlesfor Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for useby HSE’s inspectors when judging the adequacy of safety cases for nuclear facilities.The revised SAPs refer in part to HSE’s expectations relating to the technicaldiscipline of radiation protection. The purpose of this paper is to describe for thebenefit of a wider audience HSE’s reasoning behind the final published SAPs andto set out the purpose of each specific radiation protection (RP) principle. Thepaper also discusses principles in other sections of the SAPs which are relevant toradiation protection. The paper notes that the SAPs should be viewed as a reflectionof good practice in relation to nuclear facilities in the context of interpretingrelevant parts of primary legislation such as the Nuclear Installations Act 1965.

Strategies to Evaluate the Safety of Bioengineered Foods

A number of genetically modified (GM) crops bioengineered to express agronomic traits including herbicide resistance and insect tolerance have been commercialized. Safety studies conducted for the whole grains and food and feed fractions obtained from GM crops (i.e., bioengineered foods) bear similarities to and distinctive differences from those applied to substances intentionally added to foods (e.g., food ingredients). Similarities are apparent in common animal models, route of exposure, duration, and response variables typically assessed in toxicology studies. However, because of differences in the nutritional and physical properties of food ingredients and bioengineered foods and in the fundamental goals of the overall safety assessment strategies for these different classes of substances, there are recognizable differences in the individual components of the safety assessment process. The fundamental strategic difference is that the process for food ingredients is structured toward quantitative risk assessment whereas that for bioengineered foods is structured for the purpose of qualitative risk assessment. The strategy for safety assessment of bioengineered foods focuses on evaluating the safety of the transgenic proteins used to impart the desired trait or traits and to demonstrate compositional similarity between the grains of GM and non-GM comparator crops using analytical chemistry and, in some cases, feeding studies. Despite these differences, the similarities in the design of safety studies conducted with bioengineered foods should be recognized by toxicologists. The current paper reviews the basic principles of safety assessment for bioengineered foods and compares them with the testing strategies applied to typical food ingredients. From this comparison it can be seen that the strategies used to assess the safety of bioengineered foods are at least as robust as that used to assess the safety of typical food ingredients.

Safety Assessment of Foods Derived from Genetically Modified Microorganisms

Microorganisms have a long history of use in food production, e.g. in the production of sausages, cheeses, etc. Roughly one quarter of all food products rely on microbiological processes, and the safe use of microorganisms for food production is essential. The transfer of novel traits to food microorganisms through recombinant gene technology will result in new potential food safety issues. This requires the elaboration of criteria for safety assessment of foods derived from genetic microorganisms. This joint FAO/WHO Expert Consultation was convened to consider criteria for the safety and risk assessment of food and food ingredients produced with the aid of, or containing, viable or non-viable genetically modified microorganisms (GMMs). The outcome is meant to contribute to safety and regulatory considerations by Member States and to support the development of international safety assessment guidelines for food produced with the aid of GMMs (GMM food) by the Codex ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology. The Consultation concluded that the safety and risk assessment of GMM foods should proceed on a case-by-case basis considering both safety and nutritional aspects. The assessment should use the concept of substantial equivalence as a starting point, identifying differences and similarities between GMM foods and their conventional counterpart. While these differences guide the assessment, a number of additional issues require special consideration. Examples are the potential persistence of the GMM in the host gut and its interaction with the endogenous microflora, including the transfer of new genes to the gut microflora. Likewise the interaction of new genetic material with human cells in the gut, including the immune system, should be considered. The assessment of GMM foods take into consideration the history of safe use of microorganisms used in the construction. The genetic stability and pathogenic potential of the strains, as well as possible secondary effects of the genetic modification on metabolism, including the concentration of critical nutrients, antinutrients, etc. are important factors to consider. Antibiotic resistance marker genes should be avoided and their absence from the final GMM food ensured. In order to provide the basis for improved safety and risk assessment of GMM food, the Consultation recommends strengthening the capability to analyze the complex ecosystem in the human gastrointestinal tract, including work on colonization, persistence, gene transfer and host interactions. New technologies, such as molecular profiling, are developing rapidly with a potential to enhance the assessment of GMMs. The Consultation encourages further development and validation of such methods. Fermentation provides a simple technology used globally to produce food of high nutritional and hygienic quality; a technology, which is especially important in developing countries. The Consultation recommends capacity-building efforts to support the needs of developing countries in improving and evaluating this technology and its potential also in relation to GMM use. To enable efficient interaction and transparency in the safety and risk assessment of GMM food, FAO and WHO is urged to coordinate efforts to enhance the communication of safety and risk assessment principles of GMM food to all stakeholders including the public.

Principles of geomechanical safety assessment for radioactive waste disposal in salt structures

Today, a large amount of knowledge is available concerning various sites of potential high active waste (HAW) repositories in salt media. Domal Zechstein salt formations have been examined at several sites in Germany. Extensive R&D work was initiated in the former Asse Salt Mine in order to explore the suitability of salt for waste isolation by laboratory tests, theoretical studies and in-situ tests with test results forming a technological base for future repository development. Resulting from the inhomogeneity of salt structures the demanded safety of a permanent repository for radioactive wastes can be demonstrated only by a specific site analysis in which the entire system, “the geological situation, the repository, and the form and amount of the wastes” and their interrelationships are taken into consideration. The site analysis has three essential tasks: (1) Assessment of the thermomechanical load capacity of the host rock, so that deposition strategies can be determined for the site; (2) Determination of the safe dimensions of the mine (e.g. stability of the caverns and safety of the operations); and (3) Evaluation of the barriers and the long-term safety analysis for the authorization procedure. The geotechnical stability analysis is a critical part of the safety assessment. Engineering–geological study of the site, laboratory and in situ-experiments, geomechanical modelling, and numerical static calculations comprise such an analysis. Within a scenario analysis — according to the multi-barrier principle, the geological setting is checked to be able to contribute significantly to the waste isolation over long periods. The assessment of the integrity of the geological barrier can only be performed by making calculations with geomechanical and hydrogeological models. The proper idealization of the host rock in a computational model is the basis of a realistic calculation of stress distribution and excavation damage effects. The determination of water permeability along discontinuities is necessary in order to evaluate the barrier efficiency of each host rock. In this paper some important processes for the performance assessment are described, namely creep and fracturing, permeability and infiltration, and halokinesis and subrosion. For the future, the role and contributions of geoscientific and rock mechanics work within the safety assessment issues (e.g. geomechanical safety indicators) must be identified in greater detail, e.g. considerations of geomechanical natural analogy for calibration of constitutive laws.

Regulatory view of containment integrity in the United Kingdom

This paper reviews the approach of HM Nuclear Installations Inspectorate (NII) to containment integrity in the UK. The NII is the part of the regulatory authority (the Health and Safety Executive (HSE)) that administers the UK's nuclear site licensing system. A major part of the licensing process lies in the assessment of licensees' submissions for new and existing plant. The purpose of this paper is to review briefly our revised Safety Assessment Principles; describe our assessment and inspection activities on the primary containment building of the Sizewell B pressurized water reactor, which was progressing to full power operation in 1994; and to indicate our views on the possible directions for future research into containment design and performance.

UK and international standards for nuclear health and safety

This abstract summarises the licensing regime applied to nuclear installations in the UK, and explains the historical development of the NII's health and safety standards for such installations. The impact of two major public enquiries (Sizewell `B' and Hinkley Point `C') is discussed in terms of the development of NII's `Safety Assessment Principles' and HSE's `Tolerability of Risk from Nuclear Power Stations'. The role of international orgainsations (IAEA, ICRP, OECD/NEA and the EC) in developing nuclear and radiation safety standards is discussed. The paper concludes with some thoughts about how closer harmonisation might be achieved in the future.

Requirements for the primary circuit in safety standards of different countries

The design of nuclear power plants in western countries essentially is based on the ASME-Boiler and Pressure Vessel Code set up in the USA as national code which contains detailed rules regarding materials, construction, design and calculation, manufacture and quality assurance. In the different countries, however, there are various safety principles which result in national regulations and concepts. In the Federal Republic of Germany nuclear power plants are designed, constructed and operated on the basis of safety criteria, guidelines and technical codes: BMI-Safety Criteria, RSK-Guidelines, KTA Safety Standards and conventional codes and standards. The German Basis Safety Concept is an approach to nuclear power plant safety which allows the possibility of catastrophic failure to be completely excluded. There are five clearly defined principles through which high quality standards can be met during fabrication and maintained during operation. Basis Safety is provided by optimization of design, material and manufacturing. The essence is that the quality of manufacturing and design alone is sufficient to assure safety, but that this is reinforced by four more principles focussed on multiple party testing, worst case investigation, in-service monitoring and validation. In France a special regulation was created, the “Arrete of 26 Fevrier 1974”. This Arrete defines some basic principles such as the declaration of one main manufacturer, the responsibilities of the manufacturer and owner and prior information to the authorities. Basic requirements are given concerning the design, the construction, the starting, operation, maintenance and in-service inspection. The means adapted by the French manufacturer to meet these requirements are fully codified in the RCCM code (design and construction rules for mechanical components). In the USA the following safety criteria and codes form the prerequisites for the design of nuclear power plants: Code of Federal Regulations, Standard Review Plan, ASME Code and ASTM Standards. Further national codes are in the United Kingdom the British Standards, the Pre-Construction Safety Reports and the Safety Assessment Principles for Nuclear Reactors and in Japan the MITI Code. The national codes and regulations are essentially on the same level.

The Geological Disposal of Nuclear Waste

This book tackles the problems associated with the geological disposal of nuclear waste. The effects of radioactivity on the environment, radioactive waste and the fuel cycle, radionuclide migration, the building and operation of deep repositories, shallow burial and the principles of waste management and safety assessment are discussed. Detailed concepts for the long-term management and disposal of radioactive material are put forward.