Emerging risk management metrics in food safety: FSO, PO. How do they apply to the mycotoxin hazard?

This review focuses on risk management issues applied to mycotoxins and, in particular, the Codex Alimentarius recommendations for microbiological hazards are considered. Mycotoxins are chemical hazards from microbiological origin, thus some parallelisms can be found. Firstly, a revision of main points regarding risk assessment is done. Then, the existing control measures for risk management of mycotoxins are reviewed and ALOP, FSO and PO concepts are introduced. Finally, an example of the application of these metrics is included: the processing of roasted pistachio is considered. The starting point was the maximum levels in Commission Regulation 1881/2006 for total aflatoxins. Having these values in mind, the process steps were individually considered and PCs determined when required. Moreover, according to these PCs, possible PcC and PdC were calculated, using previously published results. The present study demonstrates that the emerging risk management metrics, FSO, PO and PC, might be also applied to the mycotoxin hazard. The example here presented underlines the need for better and more structured information on the impact of the storage and processing steps on mycotoxins accumulation. Moreover, the problem of the impact of uncertainty in checking PO and FSO compliance was brought up.     

Towards an FSO/ALOP based food safety policy

To gain more insight in the possible process of setting a food safety objective (FSO), a concept developed by Codex Alimentarius for microbial hazards, in national food safety policy, a study was executed in the Netherlands. This Dutch study consisted of a case study regarding the process of setting a FSO for a chemical and for a microbiological hazard as well as of a theoretical study concerning the possible development of new decision-making tools. The study resulted in a model for a decision-making process that integrates life sciences, socio-economical studies and technology assessment. It also features close interaction between policymakers and researchers. As a result of the study, it is advised to install an independent advisory committee that helps government in deciding on appropriate levels of protection of the population and setting FSOs.     

Food safety objective: An integral part of food chain management

The concept of food safety objective has been proposed to provide a target for operational food safety management, leaving flexibility in the way equivalent food safety levels are achieved by different food chains. The concept helps to better relate operational food safety management to public health goals, i.e. to an appropriate level of protection. The FSO articulates the joint target of a food chain, including all relevant links in that chain, and is common to all other food chains relevant to a pathogen/commodity combination. Performance objectives and performance criteria are two new concepts proposed recently to complement that of food safety objectives with respect to food safety control and control measures and process criteria regarding operational food safety management. All concepts together help government to give guidance to food chains about the expected safety of food products and at the same time help food chains to design their food production and food safety management systems such that there is compliance with this expectation.     

The use of quantitative risk assessment in HACCP

During the hazard analysis as part of the development of a HACCP-system, first the hazards (contaminants) have to be identified and then the risks have to be assessed. Often, this assessment is restricted to a qualitative analysis. By using elements of quantitative risk assessment (QRA) the hazard analysis can be transformed into a more meaningful managerial tool. In this way the effect of control measures can be quantified, so the occurrence of contaminants in the endproducts can be estimated. Also, the quantitative risk assessment is a tool to derive or validate control measures and critical limits at process steps (CCPs). The practical use of quantitative risk assessment is demonstrated by two examples: the risk of raw fermented sausages and the risk of a pressurized meat product. It can be concluded that quantitative risk assessment is a powerful combination of food microbiology, modelling and applied statistics. It is recommended as the input for managing food safety issues as an extension or validation of the HACCP-system.     

Summary report: Food safety objectives—role in microbiological food safety management

The Workshop, organised by ILSI-Europe, provided for the first time an opportunity for government, industry and academia to consider the implications of the evolving concept of the Food Safety Objective (FSO) in microbiological food safety management. The historic development of the concept and its relationship to other established food safety tools was discussed at length. An example application of an FSO was described for Listeria monocytogenes in cold-smoked salmon. The Workshop identified a number of conclusions and requirements for future consideration.     

The application of the Appropriate Level of Protection (ALOP) and Food Safety Objective (FSO) concepts in food safety management,using Listeria monocytogenes in deli meats as a case study

To establish a link between governmental food safety control and operational food safety management, the concepts of the Appropriate Level of Protection (ALOP) and the Food Safety Objective (FSO) have been suggested by international governmental bodies as a means for competent authorities to make food safety control transparent and quantifiable. The purpose of this study was to investigate how the concepts of ALOP and FSO could be practically linked using currently available data. As a case study, the risk of severe listeriosis due to consumption of deli meat products in the Netherlands was taken. The link between the concepts was explored following a “top-down” approach, using epidemiological country data as the starting point, and following a “bottom-up” approach, using data on the prevalence and concentration of the pathogen at retail as the starting point. For the top-down approach, the mean estimated value derived for ALOP was 3.2 cases per million inhabitants per year due to deli meats (95% CrI: 1.1–6.6). For the bottom-up approach, mean ALOP values ranged considerably, 12–44 cases per million inhabitants per year due to deli meats (with 95% CrI ranging from 5.2 to 122), depending on the combination of input parameters used in the risk assessment model. The level of detail considered in the stochastic models applied considerably influenced the ALOP and FSO estimates. Models based on both approaches however were able to describe the link between ALOP and FSO and our results showed that meaningful estimations are feasible, although interpretations need to be made with care.     

HACCP-based program for on-farm food safety for pig production in Australia

The standard Codex HACCP approach was modified to allow a hazard analysis and critical control point determination to be conducted at an industry level and then used to determine the appropriate on-farm food safety control measures for pig production in Australia. A detailed risk-based profile with hazard identification, hazard characterisation and levels of microbial contamination for production and primary processing was used as a major technical resource to inform HACCP determinations. The process resulted in the identification of Critical Control Points for control of a specific physical hazard (non-recovered broken needles) and prevention of violations of Maximum Residue Limits with agricultural and veterinary chemicals. In relation to the identified microbiological hazards, it was noted that there are numerous Good Agricultural Practices (GAP) to prevent and/or reduce their risk and these controls would also need to be a feature of any on-farm food safety program. By applying a HACCP-based approach it was determined that the application of a set of Good Agricultural Practices on-farm would be effective in ensuring low risk. It was, therefore, concluded that on-farm food safety programs may not warrant full (i.e. Codex compliant) HACCP plans at the individual enterprise level provided appropriate GAP is in place. The results provide pig producers and the Australian pig industry with the elements of a HACCP-based food safety system that are scientifically justifiable, understandable and realistic to apply. These features are essential elements that underpin successful implementation and compliance by industry.     

HACCP – The difficulty with Hazard Analysis

HACCP is a key element of modern food safety management practice such that design, implementation, control and management of HACCP systems are crucial to the production of safe food products. Whilst it is widely accepted that food companies should apply HACCP, understanding of the factors impacting successful HACCP application is limited and this knowledge is important to the delivery of systems that will control all relevant food safety hazards. HACCP principle 1, Conduct a Hazard Analysis, forms a central pillar of any HACCP plan since hazards need to be identified, analysed and understood before effective control measures can be specified. However limited guidance is available to HACCP teams on exactly how to approach the application of this principle. This paper discusses an investigation into the application of HACCP principle 1 by HACCP teams operating within manufacturing sites of a multinational food company. Using a combination of HACCP knowledge testing and HACCP plan assessment, the study identified weaknesses in knowledge of significant hazard identification and errors in the hazard analysis process, including errors in application of structured risk evaluation methods. Findings suggest that this is an area of difficulty for HACCP teams and that further detailed guidance in the application of this HACCP principle is urgently needed.     

European alerting and monitoring data as inputs for the risk assessment of microbiological and chemical hazards in spices and herbs

Food chains are susceptible to contaminations from food-borne hazards, including pathogens and chemical contaminants. An assessment of the potential product-hazard combinations can be supported by using multiple data sources. The objective of this study was to identify the main trends of food safety hazards in the European spice and herb chain, and then, evaluate how the data sources can be used during each step of a microbiological and a toxicological risk assessment. Thereafter, the possibilities and limitations of the selected data sources for the risk assessment of certain hazards in spices and herbs are examined. European governmental alerting and monitoring data and legislation were examined and evaluated for particular product-hazard combinations. Pathogenic microorganisms, particularly Salmonella spp. and pathogenic Bacillus spp., were identified as a potential concern in black pepper and dried herbs, while mycotoxins like aflatoxin (B₁) and ochratoxin A were a probable concern in chilies (including chili powder and cayenne), paprika, and nutmeg. Evaluating multiple, accessible, data sources can support several steps during the risk assessment process as seen for the hazard identification step. Therefore, identifying the potential spice and herb food safety hazards in the chain and other specific data can support risk assessors in compiling a comprehensive risk assessment.     

Derivation of performance objectives for Campylobacter in broiler carcasses taking into account impact of selected factors on pathogen prevalence and counts

Food safety standards in the European Union include microbiological criteria and targets in primary production. The current paper provides a strategy to elucidate risk-based metrics such a potential Food Safety Objective for Campylobacter used as benchmark to derive possible Performance Objectives for the pathogen in broiler carcasses tested after chilling. The Performance Objectives were developed using the EFSA data collected on broiler carcasses during the monitoring study performed in 2008 in the European Union according to the evaluation of the different risk factors included in the survey. The FSO for Campylobacter was set at −1.2 log₁₀ cfu/g (∼6 cfu/100 g). The Campylobacter concentrations after chilling resulting in a final concentration equal or below this proposed FSO were suggested as possible POs. The results obtained indicated that batches originating from previously thinned flocks can be more at risk of being colonized with Campylobacter. In fact, the estimated mean concentrations of Campylobacter on carcasses were 1.05 and 2.38 log₁₀ cfu/g for non thinned and thinned flocks, respectively. Further, the impact of high Campylobacter contamination on carcasses (>2.5 log₁₀ cfu/g) was shown since for those carcasses a reduction in PO values higher than 1.5 log₁₀ cfu/g is needed to meet the FSO. In contrast no significant differences for PO values estimated were found between slaughterhouses with different capacity and for carcasses tested at different times from collection. This study provides a validated methodology for the estimation of risk-based metrics based on a quantitative approach allowing food safety authorities to develop specific microbiological criteria.     

What risk assessments can tell us about setting criteria

The Food Safety Objective (FSO) paradigm has been developed as a risk-based approach to microbial food safety. To be operational, this paradigm requires that an Acceptable Level of Protection (ALOP) and a FSO be quantitatively defined. It then becomes the industry’s task to produce foods that achieve the FSO. A two-dimensional risk assessment, which separates variation and uncertainty, can help design a process or validate an existing process. If the initially proposed or existing process parameters do not meet the FSO, the sensitivity analysis can show which parameters have high uncertainty or variability that can be better controlled or how much a parameter must change for the process to achieve the FSO.     

Definition and usage of food safety margins for verifying compliance of Food Safety Objectives

Over the last decade, risk analysis has gradually been introduced as a tool to make decisions about food safety policies. In this framework, the ALOP (Appropriate Level of Protection) concept, which can be seen as a statement of the degree of public protection that should be attained in a country, was introduced. In addition, FSO (Food Safety Objectives) was introduced to provide a link between the ALOP and target points/goals in the supply chain. Historically, ALOP and FSO decisions have been based on the ALARA (As Low As reasonably Achievable) approach. Since an ALARA approach is based on the status of current technology, it is likely that the ALOP is attainable, provided a substantial portion of the industry complies with technological requirements or adopt “best practices” that will achieve the FSO. Food managers must control and government agencies must enforce and monitor the fulfilment of FSO. Once FSO has been established and adopted by the food industry, a major concern is to evaluate the results of the implementation of FSO in order to verify compliance. This paper introduces the concept of food safety margin (FSM) and its formulation based on classical and probabilistic approaches, which are intended to be used as a tool to measure the degree of compliance with FSO. For a better understanding of how food safety margins perform, FSM are estimated for Listeria monocytogenes in three different products, (semi-soft cheese, heat treated meat and cold smoked salmon). The results obtained, adopting both classical and probabilistic approaches, are discussed.     

The potential for third party standards at manufacturing and retail to reduce the risk of listeriosis arising from consumption of Listeria monocytogenes from ready-to-eat foods

Many third party standards are published that are either part of regional regulations or provide guidance on the control of Listeria monocytogenes in foodstuffs. These standards deal with different steps/control options for L. monocytogenes. Whereas microbiological criteria as outlined in EC regulation 2073/2005 are useful in setting performance objectives within the whole food chain, guidance on challenge studies provides the basis for harmonized approaches within industry and food safety authorities to evaluate L. monocytogenes growth potential in different foods. Other guidance documents aim towards ways of more effective Listeria control at manufacturing. The setting of governmental process and product standards link into food safety management systems by manufacturers and retailers, thereby guiding their food safety activities. The value of third party standards is discussed in conjunction with valuable inputs that can be provided by businesses having long-term experiences in related fields. Third party standards are increasingly valuable for firms to interact with partners in the food chain, so that good science plays a role in providing safe and wholesome products for the consumer without excessive government interference. Firms with long-term experiences in processing and marketing food can be important contributors to third party standards.     

海上油气生产安全风险分析

安全风险分析技术是海上油气生产安全管理的重要手段。针对“海上油气生产中因油气泄漏可能引发火灾和爆炸造成人员伤亡”进行了安全风险分析和风险评估,以影响图和事件树的具体方法介绍了安全风险分析程序,提出了风险评估中的最低合理可行原则和可接受的行业标准,并指出了我国海上油气生产中应采取的安全风险分析措施。     

预先危险性分析在天然气增压工程中的应用

通过分析活塞式天然气压缩机的主要危险及产生原因,判别其危险等级、提出消减及控制危险的对策措施。介绍了预先危险性分析方法在天然气增压工程中的具体应用,其分析结果可供安全评价及安全生产管理参考。     

Quantitative microbiological risk assessment (QMRA) of food-borne zoonoses at the European level

At EU level, the European Food Safety Authority (EFSA) is the body responsible for risk assessment in the field of food and feed safety. Following a request from European Union (EU) risk managers, the EFSA Panel on Biological Hazards (BIOHAZ) provided, for the first time, two EU-wide farm-to-fork quantitative microbiological risk assessments (QMRA), with regard to Salmonella in slaughter and breeder pigs and Campylobacter in broilers. The Scientific Opinion on a QMRA of Salmonella in pigs represented a major step forward in terms of modelling from farm to consumption as it took into account the variability between and within EU Member States. This QMRA model was developed to estimate the prevalence of infection/contamination and the microbial load from the farm to the point of consumption (exposure) and then estimating the probability of infection. It was used to investigate the effect of interventions to control Salmonella in pigs at different points of the food chain and resulted in a hierarchy of suggested on farm and slaughterhouse control measures, with estimates of the reduction of human cases. To model the effect of interventions from farm to fork on the incidence of human campylobacteriosis, a QMRA model was developed and used in the framework of the Scientific Opinion on a QMRA of Campylobacter in broiler meat. Reductions to the public health risk of campylobacteriosis could be achieved through a variety of interventions, both in primary production or at the slaughterhouse, with different impacts. Reductions of public health risk using targets at primary production or microbiological criteria were also estimated through modelling using additional models. QMRA of food-borne pathogens at European level has proven a useful/good tool to enable risk managers to evaluate the feasibility and the cost-benefit ratio of introducing control measures and targets to further protect public health of European consumers.     

HACCP system – hazard analysis and assessment,based on ISO 22000:2005 methodology

Food Safety is a fundamental public health concern, and achieving a safe supply poses major challenges for organisations involved in the food chain. A vide number of food borne hazards, both familiar and new, pose risks to health and obstructions to international trade in foods. These hazards must be properly analysed, assessed and managed to meet growing and increasingly complex sets of global food chain. Proper implementation of food hygiene principles across the food chain in conjunction with Hazard Analysis and Critical Control Point System will ensure food safety. To achieve this, a procedure for hazard analysis and assessment based on ISO 22000:2005 methodology has been developed. The hazard assessment, selection and assessment of control measures, Operational prerequisite programme Plan and HACCP Plan have been summarized in comprehensive tables.     

Implementation and effectiveness of the HACCP and pre-requisites in food establishments

The aim of this paper was to identify the most important weaknesses in the implementation and effectiveness of the pre-requisites and HACCP found in food establishments. To cover these objectives, official control audits of the manuals and their implementation in 1350 small and 66 medium size organizations: restaurants, hotels and cafeterias in one area of the Valencian region (Spain) were carried out from 2007 to 2010. The microbiological quality of 1054 ready-to-consume dishes was also evaluated as an indicator of the effectiveness of the control at Critical Control Points. The results showed that the main deficiencies in the implementation of the pre-requisites and HACCP were found in conditions and structural design followed by hygiene & cleaning. Moreover, the analysis of Listeria monocytogenes in dishes at the time of consumption shows that 99.6% were of good microbiological quality. This indicates that in relation to this hazard, the implementation of safety management systems in the majority of the food establishments was effective. These results demonstrate the crucial role played by official control to ensure the welfare of consumers and how it facilitates continuous improvement in the safety management of these businesses.     

HAZOP和LOPA在一起事故分析中的应用

针对某乙二醇装置环氧乙烷精制塔发生的一起事故进行危险和可操作性分析,找到该塔存在工艺危害因素和事故隐患,进一步运用保护层分析的方法进行半定量的计算,分析事故发生的概率和严重程度,确定事故前后的风险度。并提出了采取的保护措施,包括降低初始事件发生的频率,完善和增加安全仪表功能,使其具备独立的保护作用。使得该塔操作的风险度从高风险降低到低风险,并在可接受的风险标准以内。     

A working procedure for identifying emerging food safety issues at an early stage: Implications for European and international risk management practices

There is a need for early identification of emerging food safety issues in order to prevent them from developing into health risks. In this paper, various existing methods and procedures which can be used for early identification of safety issues are reviewed, including the monitoring of the occurrence of specific hazards within the food supply, or the incidences of food-borne diseases, as well as the combination of these data with other data or with expert opinions. Some methods, including hazard analysis critical control points (HACCP), operate pro-actively by pre-defining indicators for hazards and follow-up measures. Vulnerability assessment focuses on potential weak spots within the food supply, whilst futures research employs foresight to enhance preparedness for future hazards and risks. A Delphi survey on food safety risk analysis conducted among professionals revealed concerns with various aspects of current procedures for dealing with emerging issues, and these are discussed. The Delphi respondents also attached great value to the involvement of stakeholders and the inclusion of a broader range of data into risk analysis. Indeed, holistic systems employing indicators from outside the food production chain are now being developed. In conclusion, a four-step procedure for the early identification of emerging issues is proposed.