Guidelines For Risk Analysis Research Articles

Extended Spectrum β-Lactamase-Producing Enterobacterales of Shrimp and Salmon Available for Purchase by Consumers in Canada-A Risk Profile Using the Codex Framework.

The extended-spectrum β-lactamase (ESBL)-producing Enterobacterales (ESBL-EB) encompass several important human pathogens and are found on the World Health Organization (WHO) priority pathogens list of antibiotic-resistant bacteria. They are a group of organisms which demonstrate resistance to third-generation cephalosporins (3GC) and their presence has been documented worldwide, including in aquaculture and the aquatic environment. This risk profile was developed following the Codex Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance with the objectives of describing the current state of knowledge of ESBL-EB in relation to retail shrimp and salmon available to consumers in Canada, the primary aquacultured species consumed in Canada. The risk profile found that Enterobacterales and ESBL-EB have been found in multiple aquatic environments, as well as multiple host species and production levels. Although the information available did not permit the conclusion as to whether there is a human health risk related to ESBLs in Enterobacterales in salmon and shrimp available for consumption by Canadians, ESBL-EB in imported seafood available at the retail level in Canada have been found. Surveillance activities to detect ESBL-EB in seafood are needed; salmon and shrimp could be used in initial surveillance activities, representing domestic and imported products.

PEMETAAN RISIKO MULTIBENCANA ALAM PADA INFRASTRUKTUR JALAN

Road infrastructure as a means of transportation has an important role in the economy of a region. The ability of road infrastructure to serve the community is not only needed under normal conditions but is also needed when a disaster occurs as part of disaster resilience. One of the approaches that can be used in assessing disaster preparedness is mapping disaster risk on the road sections under review. In this research, a case study of disaster risk mapping was carried out on the Pasauran-Sp. Labuan - Cibaliung and Citereup-Tanjung Lesung, Banten Province which is divided into 11 road sections. Disaster risk mapping on roads in Padegelang is very much needed with disaster-prone locations making it very prone to disasters, especially floods, tsunamis, earthquakes, and landslides. The aim of this study is to map disaster risk based on the value of the multi-disaster risk index (floods, tsunamis, earthquakes, and landslides) on the Pasauran-Sp. Labuan-Cibaliung and Citereup-Tanjung Lesung. Disaster risk mapping is carried out using the procedures of Director General of Highways Circular Letter no. 12/SE/Db/2014 concerning Guidelines for risk analysis of natural disasters affecting roads and bridges. With this disaster risk map, it is hoped that it will be useful for stakeholders to make decisions related to disaster mitigation on these roads. The results of the multi-disaster disaster risk index values obtained from this study in sections 9, 10 and 11 have a low risk level, in sections 1,3,5 and 6 have a medium risk level, and in sections 2,4,7 and 8 have a high level of risk

A cloud model-based approach for risk analysis of excavation system

• A cloud model-based approach is proposed • Multi-source information related to excavation system are considered • A novel way is provided to perceive the risk status of excavation system • A case study for risk status perception for excavation system is illustrated • It presents guideline for risk analysis and management of excavation engineering Excavation construction in urban dense areas is regarded as a high-risk activity since there are various aspects involved and risk usually occurs in local part of excavation. This paper presents a cloud model-based approach to evaluate risk status of excavation. Multi-source information related to excavation can be coped with the developed approach. Approach development involves three phases: multi-sources information collection, construction of the benchmark cloud model (BCM) and identified cloud model (ICM), and risk level determination. Two-stage weight determination is developed to aggregate multi-sources information. An excavation project in Zhuhai is adopted to verify the performance of developed approach. Excavation was divided into subsystems according to monitoring plan of factors and risk status of subsystems is estimated based on the similar membership degree calculation between BCM and ICM. Results were found to be consistent with field situation. The sensitivity factors towards estimated risk status results were identified through correlation analysis. This proposed approach provides a novel way of perceiving the risk status of excavation and guidelines for risk management.

A scoping review of the distribution and frequency of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae in shrimp and salmon.

Antimicrobial-resistant (AMR) bacteria are a threat to public health as they can resist treatment and pass along genetic material that allows other bacteria to become drug-resistant. To assess foodborne AMR risk, the Codex Guidelines for Risk Analysis of Foodborne AMR provide a framework for risk profiles and risk assessments. Several elements of a risk profile may benefit from a scoping review (ScR). To contribute to a larger risk profile structured according to the Codex Guidelines, our objective was to conduct a ScR of the current state of knowledge on the distribution, frequency and concentrations of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae in salmon and shrimp. Articles were identified via a comprehensive search of five bibliographic databases. Two reviewers screened titles and abstracts for relevance and characterised full-text articles with screening forms developed a priori. Sixteen relevant studies were identified. This review found that there is a lack of Canadian data regarding ESBL-producing Enterobacteriaceae in salmon and shrimp. However, ESBL- producing Escherichia coli, Klebsiella pneumoniae and other Enterobacteriaceae have been isolated in multiple regions with a history of exporting seafood to Canada. The literature described herein will support future decision-making on this issue as research/surveillance and subsequent assessments are currently lacking.

Codex Alimentarius Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance Are Incompatible with Available Surveillance Data

Foodborne antimicrobial-resistant (AMR) microorganisms are a global food safety concern. Antimicrobial drug use (AMU) in livestock may increase the risk of resistant foodborne bacterial infections in humans via contaminated animal products. Consequently, countries have implemented different livestock AMU restriction policies, opening the potential for trade disputes. AMR risk equivalence between countries with different AMU policies must be established by using scientifically justified risk assessments. The Codex Alimentarius Commission's Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance (AMR Codex) recommends an approach that requires quantification of detailed information, for which, in many instances, little to no data exist. Using AMR Salmonella exposure from beef consumption as an example, we demonstrate the difficulty of implementing the AMR Codex by comparing key regionally specific parameters within the United States and European Union, two regions with substantial beef production and consumption, robust foodborne pathogen sampling and surveillance systems, and different AMU policies. Currently, neither region fully captures data for key regional variables to populate a detailed risk assessment as outlined in the AMR Codex, nor are they able to adequately link AMU in livestock to AMR infections in humans. Therefore, the AMR Codex guidelines are currently aspirational and not a viable option to assess the impact of livestock AMU reductions on the human health risk of AMR salmonellosis from beef or produce regionally comparable estimates of risk. More flexible risk assessment guidelines that more directly link livestock AMU to human health risk and are amenable to currently available data are needed to allow for country variations and to calculate comparable regional risk estimates, which can be used to guide international trade policy.

Assessment of potential hazards of the inadvertently present chemicals in food

During the 71st session of the Executive Committee of the Codex Alimentarius Commission, New Zealand proposed draft Guidelines for risk analysis of chemicals inadvertently present in food at low levels, noting that regulatory documents do not currently cover this group of substances. Methodological approaches to detecting and identifying chemical substances inadvertently present in foodstuffs were proposed In the Russian Federation. The developed methodological approaches include four stages: analytical identification of chemical substances; integrated assessment of chemical hazards employing additional selection criteria followed by the application of a score and summation of points; categorizing chemical substances with the assignment of potential hazard categories and final stage - health risk assessment for selected chemicals based on the integrated index. The presented methodological approaches were tested on the example of canned meat for infant nutrition consumed in the Russian Federation and the Socialist Republic of Vietnam. Nnitrosamines were assessed as a priority potentially hazardous inadvertently present chemical substance in samples of canned meat for infant nutrition for health risk assessment using methodological approaches developed in the Russian Federation. Assessment of the health risk to infants when consuming canned meat for infant nutrition containing Nnitrosamines on the example of products sold in the Russian Federation and the Socialist Republic of Vietnam revealed no excess hazard quotients (HQ < 1.0) in both territories. However, the calculation of carcinogenic risks has shown that when canned meat for infants sold in the Russian Federation from 6 months to 3 years of age is consumed, a carcinogenic risk may be formed in infants of the corresponding group. This difference between the Socialist Republic of Vietnam and the Russian Federation is due not only to the difference in the content of N-nitrosamines in the examined product but also to the greater volume of canned meat consumption in Russia.

A farm-to-fork quantitative risk assessment model for Salmonella Heidelberg resistant to third-generation cephalosporins in broiler chickens in Canada

Salmonella Heidelberg resistant to ceftiofur (a third-generation cephalosporin antimicrobial agent) in broiler chicken products pose a risk to public health in Canada. The objective of this study was to assess the extent of that risk and to evaluate the effect of intervention measures along the agri-food chain. A stochastic farm-to-fork quantitative microbial risk assessment model was developed following the Codex Alimentarius Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance. Different scenarios were analyzed to assess the individual relative effects of 18 possible interventions in comparison to a baseline scenario. The baseline scenario represented the first year of on-farm antimicrobial use surveillance in the Canadian broiler industry and the year before an industry-imposed ban on the preventive use of antimicrobials of very high importance to human health (2013), where 31.3% of broiler flocks consisted of birds to which ceftiofur was administered.The baseline scenario predicted an average probability of illness of 1.1 per 100,000 servings (SE: 0.064 per 100,000), corresponding to an average of 22,000 human infections (SE: 1900) with ceftiofur-resistant S. Heidelberg per year, which is likely an overestimation. This risk was reduced by 90% or 20% when two separate scenarios designed to capture the effect of withdrawing preventive ceftiofur use from poultry production were simulated using different approaches; data used for the former scenario were confounded by other potential concomitant control measures (e.g. Salmonella vaccination programme), so the true effect likely lies somewhere between the two estimates. A theoretical ‘worst case’ scenario where all flocks had birds exposed to ceftiofur increased the risk by 107%. A 50% reduction in the probability of human prior exposure to antimicrobials, which has a selective and competitive effect for Salmonella spp. following ingestion of contaminated products, reduced the risk by 65%. Other promising measures that could be considered for further risk management included improved cleaning and disinfection between broiler flocks on farm (risk reduction by 26%), exclusive use of air chilling (risk reduction by 34%), and the improvement of meat storage and preparation conditions, e.g., no temperature abuse at retail (risk reduction by 88%). These findings showed the importance of a structured approach to assessing and potentially implementing effective interventions to reduce the risk associated with ceftiofur-resistant S. Heidelberg at different steps along the agri-food chain.Major data gaps included information on concentrations of resistant bacteria, cross contamination at processing and how ceftiofur-resistant S. Heidelberg behave in comparison with susceptible ones, e.g., in terms of growth and survival ability, as well as pathogenicity and virulence.

Integrating Whole-Genome Sequencing Data Into Quantitative Risk Assessment of Foodborne Antimicrobial Resistance: A Review of Opportunities and Challenges.

Whole-genome sequencing (WGS) will soon replace traditional phenotypic methods for routine testing of foodborne antimicrobial resistance (AMR). WGS is expected to improve AMR surveillance by providing a greater understanding of the transmission of resistant bacteria and AMR genes throughout the food chain, and therefore support risk assessment activities. At this stage, it is unclear how WGS data can be integrated into quantitative microbial risk assessment (QMRA) models and whether their integration will impact final risk estimates or the assessment of risk mitigation measures. This review explores opportunities and challenges of integrating WGS data into QMRA models that follow the Codex Alimentarius Guidelines for Risk Analysis of Foodborne AMR. We describe how WGS offers an opportunity to enhance the next-generation of foodborne AMR QMRA modeling. Instead of considering all hazard strains as equally likely to cause disease, WGS data can improve hazard identification by focusing on those strains of highest public health relevance. WGS results can be used to stratify hazards into strains with similar genetic profiles that are expected to behave similarly, e.g., in terms of growth, survival, virulence or response to antimicrobial treatment. The QMRA input distributions can be tailored to each strain accordingly, making it possible to capture the variability in the strains of interest while decreasing the uncertainty in the model. WGS also allows for a more meaningful approach to explore genetic similarity among bacterial populations found at successive stages of the food chain, improving the estimation of the probability and magnitude of exposure to AMR hazards at point of consumption. WGS therefore has the potential to substantially improve the utility of foodborne AMR QMRA models. However, some degree of uncertainty remains in relation to the thresholds of genetic similarity to be used, as well as the degree of correlation between genotypic and phenotypic profiles. The latter could be improved using a functional approach based on prediction of microbial behavior from a combination of ‘omics’ techniques (e.g., transcriptomics, proteomics and metabolomics). We strongly recommend that methodologies to incorporate WGS data in risk assessment be included in any future revision of the Codex Alimentarius Guidelines for Risk Analysis of Foodborne AMR.

Ceftiofur-resistant Salmonella enterica serovar Heidelberg of poultry origin - a risk profile using the Codex framework.

Codex published the 'Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance' to standardise the approach for evaluating risk posed by foodborne antimicrobial-resistant bacteria. One of the first steps in the guidelines is to compile a risk profile, which provides the current state of knowledge regarding a food safety issue, describes risk management options and recommends next steps. In Canada, ceftiofur/ceftriaxone-resistant Salmonella enterica subsp. enterica serovar Heidelberg from poultry was identified as an antimicrobial resistance (AMR) food safety issue. The first objective of this article was to contextualise this food safety issue, using the risk profile format of the Codex Guidelines. A second objective was to evaluate the applicability of the Codex Guidelines. This risk profile indicated that ceftiofur/ceftriaxone-resistant S. Heidelberg (CSH) was commonly isolated from poultry and was associated with severe disease in humans. Ceftiofur use in poultry hatcheries temporally mirrored the prevalence of CSH from poultry meat at retail and from people with salmonellosis. The evidence was sufficient to indicate the need for risk management options, such as restricting the use of ceftiofur in poultry. The Codex Guidelines provided a useful approach to summarise data for decision-makers to evaluate an AMR food safety issue.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses

The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the “General guidelines on risk management in external beam radiotherapy” were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons.

Risk Ranking of Antimicrobial-Resistant Hazards Found in Meat in Switzerland.

Human exposure to bacteria resistant to antimicrobials and transfer of related genes is a complex issue and occurs, among other pathways, via meat consumption. In a context of limited resources, the prioritization of risk management activities is essential. Since the antimicrobial resistance (AMR) situation differs substantially between countries, prioritization should be country specific. The objective of this study was to develop a systematic and transparent framework to rank combinations of bacteria species resistant to selected antimicrobial classes found in meat, based on the risk they represent for public health in Switzerland. A risk assessment model from slaughter to consumption was developed following the Codex Alimentarius guidelines for risk analysis of foodborne AMR. Using data from the Swiss AMR monitoring program, 208 combinations of animal species/bacteria/antimicrobial classes were identified as relevant hazards. Exposure assessment and hazard characterization scores were developed and combined using multicriteria decision analysis. The effect of changing weights of scores was explored with sensitivity analysis. Attributing equal weights to each score, poultry-associated combinations represented the highest risk. In particular, contamination with extended-spectrum β-lactamase/plasmidic AmpC-producing Escherichia coli in poultry meat ranked high for both exposure and hazard characterization. Tetracycline- or macrolide-resistant Enterococcus spp., as well as fluoroquinolone- or macrolide-resistant Campylobacter jejuni, ranked among combinations with the highest risk. This study provides a basis for prioritizing future activities to mitigate the risk associated with foodborne AMR in Switzerland. A user-friendly version of the model was provided to risk managers; it can easily be adjusted to the constantly evolving knowledge on AMR.

Quantitative Risk Analysis of Offshore Fire and Explosion Based on the Analysis of Human and Organizational Factors

A dynamic risk analysis model of offshore fire and explosion is proposed in this paper. It considers the effect of human and organizational factors in a more explicit way than current traditional risk analysis methods. This paper begins with exploring the recent advances on offshore fire and explosion risk analysis theories, followed by briefly introducing the research techniques employed in the proposed hybrid causal logic model which consists of event tree, fault tree, Bayesian network, and system dynamics. Thereafter, it proposes a quantitative risk analysis framework. At last, the applicability of this model to the offshore platform is also discussed. It aims to provide guideline for risk analysis of offshore fire and explosion.

Patient safety in external beam radiotherapy – Guidelines on risk assessment and analysis of adverse error-events and near misses: Introducing the ACCIRAD project

In 2011 the European Commission launched a tender to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy. This tender was awarded to a consortium of 6 institutions, including the ESTRO, in late 2011. The project, denominated “ACCIRAD”, recently finished the data collection phase. Data were collected by surveys administered in 38 European countries. Results indicate non-uniform implementation of event registration and classification, as well as incomplete or zero implementation of risk assessment and events analysis. Based on the survey results and analysis thereof, project leaders are currently drafting proposed guidelines entitled “Guidelines for patient safety in external beam radiotherapy – Guidelines on risk assessment and analysis of adverse-error events and near misses”. The present article describes the aims and current status of the project, including results of the surveys.

Antimicrobial resistance and the activities of the Codex Alimentarius Commission

The Codex Alimentarius Commission has been working on the subject of antimicrobial resistance, mainly through the activities of the Committee on Residues of Veterinary Drugs in Foods and the ad hoc Intergovernmental Task Force on Antimicrobial Resistance. Principal texts developed by Codex include the 'Code of Practice to Minimize and Contain Antimicrobial Resistance (CAC/RCP 61-2005) and 'Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance' (CAC/GL 77-2011). The successful containment of antimicrobial resistance requires the collaboration of a wide range of stakeholders, working together to protect consumer health by ensuring the safety of food products of animal origin.

Identification and evaluation of priorities in the business process of a risk or safety organization

Agencies are increasingly following principles and guidelines for the coordination of risk assessment, risk management, and risk communication in large-scale programs. In particular, there is a challenge to comply with the U.S. Office of Management and Budget (OMB) memorandum “Updated Principles for Risk Analysis” among other guidelines. This paper demonstrates a systemic approach to achieve compliance of a risk program with administrative and organizational principles and guidelines for risk analysis. The paper suggests three canonical questions as the mission of such a program: (i) what sources of risks are to be managed by the program, (ii) how should multiple risk assessment, risk management, and risk communication activities be administered and coordinated, and what should be the basis for resource allocation to these activities, and (iii) how will the performance of the program be monitored and evaluated. The paper demonstrates a re-prioritization of policy initiatives of the program based on emergent and future conditions. The approach is useful to agencies implementing risk or safety organizational guidelines such as those of the OMB, the US Government Accountability Office, the US Department of Homeland Security, the US Department of Defense, and others. This paper will be of interest to risk managers; agencies; and risk and safety analysts engaged in the conception, implementation, and evaluation of risk or safety programs.

Global trade in ornamental fish from an Australian perspective: The case for revised import risk analysis and management strategies

Over 1 billion ornamental fish comprising more than 4000 freshwater and 1400 marine species are traded internationally each year, with 8–10 million imported into Australia alone. Compared to other commodities, the pathogens and disease translocation risks associated with this pattern of trade have been poorly documented. The aim of this study was to conduct an appraisal of the effectiveness of risk analysis and quarantine controls as they are applied according to the Sanitary and Phytosanitary (SPS) agreement in Australia. Ornamental fish originate from about 100 countries and hazards are mostly unknown; since 2000 there have been 16-fold fewer scientific publications on ornamental fish disease compared to farmed fish disease, and 470 fewer compared to disease in terrestrial species (cattle). The import quarantine policies of a range of countries were reviewed and classified as stringent or non-stringent based on the levels of pre-border and border controls. Australia has a stringent policy which includes pre-border health certification and a mandatory quarantine period at border of 1–3 weeks in registered quarantine premises supervised by government quarantine staff. Despite these measures there have been many disease incursions as well as establishment of significant exotic viral, bacterial, fungal, protozoal and metazoan pathogens from ornamental fish in farmed native Australian fish and free-living introduced species. Recent examples include Megalocytivirus and Aeromonas salmonicida atypical strain . In 2006, there were 22 species of alien ornamental fish with established breeding populations in waterways in Australia and freshwater plants and molluscs have also been introduced, proving a direct transmission pathway for establishment of pathogens in native fish species. Australia's stringent quarantine policies for imported ornamental fish are based on import risk analysis under the SPS agreement but have not provided an acceptable level of protection (ALOP) consistent with government objectives to prevent introduction of pests and diseases, promote development of future aquaculture industries or maintain biodiversity. It is concluded that the risk analysis process described by the Office International des Epizooties under the SPS agreement cannot be used in a meaningful way for current patterns of ornamental fish trade. Transboundary disease incursions will continue and exotic pathogens will become established in new regions as a result of the ornamental fish trade, and this will be an international phenomenon. Ornamental fish represent a special case in live animal trade where OIE guidelines for risk analysis need to be revised. Alternatively, for countries such as Australia with implied very high ALOP, the number of species traded and the number of sources permitted need to be dramatically reduced to facilitate hazard identification, risk assessment and import quarantine controls.

Regulations of major accident hazards control in Serbia and their implementation

Abstract The paper presents a brief summary of contents and implementation of the current Serbian regulations on the prevention and control of major accidents involving dangerous materials. Further, it discusses issues connected with implementation of the regulation, including inspection, review, and approval of safety reports. This regulation comprises legal requirements and methodological guidelines for risk analysis and preparation of emergency plans. Although the roots of the Serbian regulation are basically in the Seveso I Directive, this study revealed significant differences compared with current regulations and practice in Europe.

Managing Actuaries\' Professional Risk

This paper describes a new concept, of vital importance to actuaries, which the authors have named \'managing actuaries\' professional risk\'. Much has been written on the constituent elements of legal causation, risk management, indemnity insurance and professional conduct standards. This paper envisages an integration of these elements using the profession\'s own guidelines for risk analysis and management for projects (RAMP). Actuaries are experts in risk applications for clients-in an increasingly litigious society, they need to apply their expertise in their own back yard.KEYWORDS Professionalism; professional risk; risk management; professional indemnity insurance. (South African Actuarial Journal: 2002 2: 29-52)