The SAFE FOODS Risk Analysis Framework suitable for GMOs? A case study

Millions of people have no access to healthy and safe food due to food insecurity that may occur at household, regional or national levels. National policies, insufficient agricultural development and low levels of education may lead to food insecurity. Furthermore, food quality and food safety is a major benchmark of economic development. Food borne risks to human health can arise from biological, chemical or physical hazards. Risk analysis is a key discipline for reducing food borne diseases and food insecurity, and for strengthening food safety systems. Food safety risk analysis is used for assessing and managing risks associated with food hazards. The risk analysis process contains three elements: risk assessment, risk management and risk communication. This paper focuses on risk communication and summarizes the results and findings of the case study for official food safety communicators. The preliminary descriptive study intends to present the reaction of Hungarian consumers to a crisis that affected a wide range of society. In 2007, the guar gum scandal caused panic among consumers when dioxin-contaminated guar gum entered the food chain. This food contamination scare followed previous occasions such as production of intoxicated paprika powder, re-labelling of overdue meat packages and the Bovine spongiform encephalopathy (BSE) crisis in Hungary. To analyze risk perception and consumer behavior, a primary research was conducted with a sample size of 1,577.

The scientific Panel of the European Food Safety Authority (EFSA) on genetically modified organisms (GMOs) developed guidelines for the environmental risk assessment of genetically modified (GM) animals that provide specific recommendations for GM fish, GM insects, GM mammals and GM birds. The guidelines advocate that the environmental risk assessment of GM animals is conducted on a case-by-case basis, in a scientifically sound and transparent manner, and follows common methodology for the identification, gathering and interpretation of the data. Besides specific considerations, the guidelines provide generic advice on the choice of comparators, the use of non-GM surrogates, the assessment of long-term effects, uncertainty analysis, modelling requirements and statistical principles. Three dedicated Working Groups of the EFSA GMO Panel were involved in the elaboration of the environmental risk assessment guidelines, which underwent a public consultation before finalisation. Relevant comments received from risk assessment bodies of EU Member States, the scientific community, stakeholders and the public were considered by the Working Groups. The Working Groups also took into account the external scientific reports on GM fish, GM insects, GM mammals and GM birds commissioned by EFSA. These reports provided background information by mapping relevant fields of expertise and identifying essential elements to be considered when performing an environmental risk assessment of GM animals.

Through policy, guidance and the use of current software, the U. S. Army Corps of Engineers (USACE) has defined a risk analysis process that can identify potential system-wide hydraulic impacts resulting from alterations to a system of levees. However, as was demonstrated through the Hydrologic Engineering Center's (CEIWR-HEC) study of the Sacramento River Flood Control Project (SRFCP), this current procedure can be difficult to follow and implement. Studies such as the SRFCP are being performed using the tool HEC-FDA (Flood Damage Reduction Analysis). Among other things, HEC-FDA develops project performance metrics for comparison of alternatives and levee certification and since 1996 has included the capabilities to perform risk analyses. However, even with these advanced capabilities, HEC-FDA still looks at a system of levees as a number of independent projects. This issue and others raised by the National Research Council, current users of HEC-FDA and CEIWR-HEC have clearly shown that an enhanced version of HEC-FDA needs to include explicit systems analysis capabilities. For this reason, CEIWR-HEC began the development of a new tool to analyze complex riverine systems while implementing the current flood risk analysis and systems requirements. This new tool, currently called HEC-WAT (Watershed Analysis Tool) along with its Flood Risk Management compute option, FRM, is the next generation of CEIWR-HEC's HEC-FDA model. HEC-WAT/FRM will include a systems approach, event-based sampling to enable system modeling, the ability to do scenario and alternative analyses, and will be used nationwide for levee certification, levee assessment, planning and design studies and advance the Corps modeling approach for risk analysis. An initial implementation of the HEC-WAT/FRM is being constructed for the Columbia River Treaty (CRT) 2014/2024 project. This paper will describe the HEC-WAT/FRM and how it will be used to address levee certification and assessment for the CRT study and how it will advance the Corps modeling approach for risk analysis.

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.

“RiskBenefit4EU - Partnering to strengthen the risk-benefit assessment within EU using a holistic approach” was a knowledge transfer project funded by the European Food Safety Authority (EFSA) that integrated a multidisciplinary team from Portugal, Denmark and France. This project aimed to strengthen the EU capacity to assess risks and benefits associated with human food consumption, considering the fields of toxicology, microbiology and nutrition. To train the recipient partners from Portugal on Risk-Benefit Assessment (RBA), a capacity-building program was implemented, including three main activities: theoretical training on RBA concepts; hands-on training applying concepts to a case-study using methods and tools displayed; and scientific missions to provide advanced training in specific domains of RBA. The developed RBA strategy was applied to a case study focusing on the RBAof the consumption of cereal-based products by Portuguese young children. Risks due to aflatoxins, Bacillus cereus, sodium and free sugars, were evaluated, as well as the benefit of fibreintake. Five different scenarios of infant cereals and/or breakfast cereals consumption were considered, and the assessment showed that moving from the current consumption to the considered alternative scenarios wouldresult in a gain of healthy-life years. The RiskBenefit4EU project applied a collaborative method to train a new team to perform RBAs of foods and face the challenge of cooperation between experts from different disciplines. During the process of capacity building, a movement from conceptual knowledge towards action was an essential step to effectively increase performance. The developed framework facilitated the case-study accomplishment and contributed to build a shared and harmonized RBA approach and culture. The suggested strategy can now be re-used to capacitate other teams in RBA,and can be considered as a basis to build upon.

EFSA Supporting PublicationsVolume 12, Issue 12 918E External scientific reportOpen Access Use of the EFSA Standard Sample Description ver. 2.0 (SSD2) for the reporting of data on the control of pesticide residues in food and feed according to Regulation (EC) No 396/2005 National Sanitary Veterinary and for Food Safety Authority of Romania (ANSVSA), National Sanitary Veterinary and for Food Safety Authority of Romania (ANSVSA) National Sanitary Veterinary and for Food Safety Authority of Romania (ANSVSA)Search for more papers by this author National Sanitary Veterinary and for Food Safety Authority of Romania (ANSVSA), National Sanitary Veterinary and for Food Safety Authority of Romania (ANSVSA) National Sanitary Veterinary and for Food Safety Authority of Romania (ANSVSA)Search for more papers by this author First published: 17 December 2015 https://doi.org/10.2903/sp.efsa.2015.EN-918 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. Published date: 17 December 2015 Question number: EFSA-Q-2014-00487 AboutReferencesRelatedInformationPDFPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessClose modalShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL References EFSA (European Food Safety Authority), 2010. Standard sample description for food and feed. EFSA Journal 2010; 8(1):1457, 54 pp. doi:10.2903/j.efsa.2010.1457 EFSA (European Food Safety Authority), 2014a. Use of the EFSA Standard Sample Description for the reporting of data on the control of pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2013 Data Collection). EFSA Journal 2014; 12(1):3545 60 pp. doi:10.2903/j.efsa.2014.3545 EFSA (European Food Safety Authority), 2014b. Guidance on the data exchange version 2.0. EFSA Journal 2014; 12(12):3945, 173 pp. doi:10.2903/j.efsa.2014.3945 EFSA (European Food Safety Authority), 2015a. The EFSA Data Warehouse access rules. EFSA supporting publication 2015:EN-76, 18 pp. EFSA (European Food Safety Authority), 2015b. The 2013 European Union report on pesticide residues in food. EFSA Journal 2015; 13(3):4038, 169 pp, doi:10.2903/j.efsa.2015.4105 EFSA (European Food Safety Authority), 2015c. Guidelines for reporting data on residues of veterinary medicinal products. EFSA supporting publication 2015:EN-783. 77 pp. European Commission, 2013. Guidance document on analytical quality control and validation procedures for pesticide residues analysis in food and feed. SANCO/12571/2013. Volume12, Issue12December 2015918E ReferencesRelatedInformation RecommendedUse of the EFSA Standard Sample Description for the reporting of data on the control of pesticide residues in food and feed according to Regulation (EC) No 396/2005European Food Safety Authority, EFSA JournalUse of the EFSA Standard Sample Description for the reporting of data on the control of pesticide residues in food and feed according to Regulation (EC) No 396/2005 (revision 1)European Food Safety Authority, EFSA JournalUse of the EFSA Standard Sample Description (SSD) for the reporting of data on the control of pesticide residues in food and feed according to Regulation (EC) No 396/2005 (Version: 2013 Data Collection)European Food Safety Authority, EFSA JournalStandard Sample Description ver. 2.0European Food Safety Authority, EFSA JournalEFSA Catalogue browser User GuideEuropean Food Safety Authority (EFSA), Sofia Ioannidou, EFSA Supporting Publications

Models, modelling and modellers: an application to risk analysis

The chapter analyses the gradual evolution in EU food law, turning to food and feed safety protection following the serious food crises of the 1990s. The comprehensive, integrated principles underlying the 1993 Green Paper and 2000 White Paper became a reality with Regulation (EC) No. 178/2002, which ascribes a crucial role to consumer protection, setting forth the principles of transparency, traceability, and responsibility of business operators; establishing a rapid alert system and crisis management plan; and, most importantly, establishing the European Food Safety Authority (EFSA). EFSA provides scientific opinions and scientific and technical assistance, establishes surveillance procedures, promotes cooperation among food safety organisations, and plays a crucial role in risk assessment and communication. EFSA’s first 10 years of activity has achieved a positive balance: despite the dramatic changes within the EU, it has successfully adapted itself. The need for the harmonisation of food hygiene requirements led to the adoption of the hygiene package and the HACCP system (Reg. 852/2004), as well as of specific hygiene rules applicable to products of animal origin (Reg. 853/2004). The conclusions drawn are encouraging: EU food law, by adopting harmonised vertical rules and regulations common to all operators, has committed to ensuring common, high quality standards. EU authorities’ capacity to promptly and effectively react to significant food crises has led to one of the most developed systems worldwide, one that is functional for operators and safe for consumers. Yet the need for rapid, repeated actions, is a constant challenge, which certainly cannot be considered complete.

This is a comment on Lofstedt and Bouder’s paper, which explores the prospects of evidence based uncertainty analysis in Europe, focusing on the ongoing development on uncertainty analysis at the European Food Safety Authority (EFSA). We very much welcome a discussion on the need to develop better treatment and communication of uncertainty in risk analysis, as we believe that such discussion is long overdue. Lofstedt and Bouder raise many relevant points, in particular the call for evidence based uncertainty analysis. However, there is need to distinguish different types of communication in the discussion and facilitate – not diminish – the description and communication of uncertainty between risk assessors and decision-makers. We find that EFSA has taken steps toward a novel approach to guide their scientific experts and risk assessors in uncertainty analysis based on a modern and scientific view on uncertainty.

Food risk analysis remains a major cornerstone that provides a framework for the risk-based food safety system. This paper aimed at evaluating the effectiveness of the food safety system, and the foundational role and opportunities of the risk analysis concept in the East Africa Community (EAC). The study was done through the explorative review of the literature as the best approach to getting broad information on the concept of risk analysis in global food safety and its impact on food safety systems. Through analysis of the relevant literature and previous studies related to global food safety and food safety systems, the approach helped to draw on challenges and opportunities and to reformulate the potential key role of the risk analysis concept in the EAC food safety system. Challenges were identified through the evaluation of the effectiveness of the EAC food safety system with reference to the US- effective food safety model. The role and opportunities of the risk analysis in the EAC food safety system were evaluated against identified challenges, and its implementation feasibility and assets in the EAC food safety system. As results, the EAC food safety system showed many gaps and challenges, and was ineffective. While the risk analysis concept was found a key factor in attributes of the effective food safety system, it could help the EAC food safety system to become effective, and to respond to the current and future food safety needs of both the African continent and the Globe. With many opportunities and potentials in EAC, the risk analysis concept can be integrated into the EAC food safety system. Therefore, a useful and strategic approach as a model of the integration of the risk analysis concept was designed for EAC. It is the establishment of an EAC- Regional Centre of Expertise in Food Risk Analysis (EAC-CREFRA). In addition, the EAC food safety system needs to anchor One Health and multi-factorial food safety management approaches to food safety.

European regulations on nutraceuticals, dietary supplements and functional foods: A framework based on safety

A key feature of risk analysis is that risk assessment and risk management should be functionally separated. However, the usefulness of a risk assessment may be limited if the output is not designed to help with risk management decisions. The COMRISK project investigated the communication between risk assessors and risk managers. The overall goal of the project was to identify current practices and challenges in communication between risk assessors and risk managers during the risk analysis process, and thus increase and improve the understanding and the quality of the communication between them. Specific actions to achieve this aim included reviewing of historical food safety cases, analysing risk assessment requests, identifying communication guiding documents, including legislation and agreements, conducting semi-structured interviews with risk assessors and risk managers, and identifying tools for facilitating the communication between risk assessors and risk managers. It was concluded that the usefulness of a risk assessment is strongly dependent on well-defined and mutually recognised risk questions and that scarce or poor communication between risk assessors and risk managers is one of the major reasons when an output from risk assessment fails to support risk management. The communication between risk assessors and risk managers preceding the onset of the risk assessment, when the risk assessment requests with its risk questions are defined, is especially identified as one of the critical points to ensure a risk assessment that is fit for purpose. However, difficulties in understanding were also reported for the communication between risk assessors and risk managers during and after the risk assessment. Lack of communication is seldom a result of formal constraints or agreements nor can it be explained by a wish of the risk assessors or risk managers. Instead, perceived constraints or traditions appear to be possible underlying factors leading to scarce or poor communication between risk assessors and risk managers. It is essential that both risk assessors and risk managers acknowledge the crucial importance of communication between them while at the same time respect their different roles in a risk analysis.According to respondents, the best solution to facilitate the framing of the risk assessment questions isan open dialogue between risk assessors and risk managers to agree on the goal of the assessment and to build trust. Further, the interviewresults indicate that a formal systematic process may facilitate communication during the risk analysis. Where there is uncertainty, e.g due to data gaps or issues related to the methodology and models, it should be acknowledged and described properly by risk assessors to risk managers. Training of risk assessors and risk managers may improve the possibility of a timely and fit-for-purpose output.Such a training should give a deeper insight in the risk management process, give a better understanding of the risk managers role, and especially raise the awareness of the importance of the communication between risk assessors and risk managers.To improve the risk analysis process, it is also important that the risk assessor gets feedback regarding how risk assessments have met the needs of the risk managers.The present study also found that aspects of risk communication studied in this project are not extensively discussed in the guidance documents for risk analysis. More research is needed to identify the barriers for a fit for purpose communication.

To benefit from cloud computing and the advantages it offers, obstacles regarding the usage and acceptance of clouds have to be cleared. For cloud providers, one way to obtain customers' confidence is to establish security mechanisms when using clouds. The ISO 27001 standard provides general concepts for establishing information security in an organization. Risk analysis is an essential part in the ISO 27001 standard for achieving information security. This standard, however, contains ambiguous descriptions. In addition, it does not stipulate any method to identify assets, threats, and vulnerabilities. In this paper, the authors present a method for cloud computing systems to perform risk analysis according to the ISO 27001. The authors' structured method is tailored to SMEs. It relies upon patterns to describe context and structure of a cloud computing system, elicit security requirements, identify threats, and select controls, which ease the effort for these activities. The authors' method guides companies through the process of risk analysis in a structured manner. Furthermore, the authors provide a model-based tool for supporting the ISO 27001 standard certification. The authors' tool consists of various plug-ins for conducting different steps of their method.

A risk analysis approach emphasizes a shared responsibility for communication about food safety issues by all interested parties including government regulatory officials, industry, consumers, and academics. The three components of risk analysis are risk management, risk assessment, and risk communication. This chapter discusses the use of a risk analysis framework within a food safety context with emphasis on microbiological (biological) hazards, how risk analysis has been implemented in U.S. regulatory agencies and international organizations, and future needs to strengthen the use of risk analysis to help solve food safety issues. Risk analysis requires the interaction of individuals with diverse skills and perspectives, including expertise in communication, coordination, project management, scientific knowledge, and skills in data analysis and modeling. To efficiently allocate resources to address food safety issues, it is vital to establish annual food safety risk management priorities. Risk analysis is emerging as a public health tool that promises to provide a sound scientific basis for developing national and international standards and guidelines for food safety and for supporting risk-based policies and practices to prevent food-borne illness.

EFSA Supporting PublicationsVolume 9, Issue 5 276E Technical reportOpen Access Annual report on EFSA's food and feed safety crisis preparedness and response 2011 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 08 May 2012 https://doi.org/10.2903/sp.efsa.2012.EN-276Citations: 1 Published date: 8 May 2012 Question number: EFSA-Q-2011-00398 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Citing Literature Volume9, Issue5May 2012276E ReferencesRelatedInformation