Until 1997, a proposed tolerable limit, e.g., level of consumption/kg body weight/day, was set for non-genotoxic substances or a recommendation of levels "as low as reasonably achievable" (ALARA) was made for genotoxic substances. Improvements in mycotoxin detection and the implications for health, trade and food availability lead to the development of risk analysis methodology that requires more detailed information on mycotoxin actions and interactions. Risk analysis strengthens the ability of traditional food safety systems by providing a framework to effectively manage, assess and communicate risks in cooperation with diverse stakeholders allowing effective decision-making.
Risk analysis, as defined by the Codex Alimentarius (FAO/WHO/UNEP, 1999; Codex Alimentarius, 2003b), has three components: risk assessment, risk management and risk communication. These components are interdependent and cannot occur separately. The process often begins with risk management, which defines the problem, articulates the goals of the risk analysis and defines the questions to be answered by the risk assessment. The science-based tasks of "measuring" and "describing" the nature of the risk being analyzed, i.e., risk characterization, are part of the risk assessment.
Risk communication encompasses an interactive exchange amongst risk managers, risk assessors, the risk analysis team, consumers and stakeholders. The process often culminates with action being taken by the risk managers. This approach increases the ability of food safety regulators to identify hazards, characterize them, assess exposure, and estimate the likelihood of the resulting risks to and potential impact on human health.
A science-based approach strengthens traditional food safety systems, minimizes food-borne hazards, enables risk management, and improves decision-making processes. This concept is not new and is closely related to good practices (agricultural, hygienic and manufacturing) and to the Hazard Analysis and Critical Control Point system (HACCP) already in place in many countries. What is new is the use of risk analysis as a framework to view and to respond to food safety problems in a systematic, structured, scientific manner that increases the quality of the decision-making process. Mycotoxins are natural contaminants that are particularly difficult for risk assessors, as they usually are considered unavoidable and therefore must be regulated differently than synthetic chemicals, which are considered avoidable. Thus, small amounts of mycotoxins are allowed in foods if the permitted levels are not injurious to human or animal health (Miller, 1998).
Natural chemical contaminants produced by biological organisms usually are considered independently of the producing organism with respect to hazard identification and characterization. However, identification of a producing organism may be of use in hazard assessment before the chemical contaminant is characterized. The producing organism also is an important factor in risk management since control strategies that target the producing organism may be the most effective way to reduce the levels of the contaminant in food.
Understanding the environmental and physiological factors that control mycotoxin production is critical if models predicting contamination levels are to be developed and for the development of control strategies. Often, multiple toxigenic fungi may be present and each species may produce a different spectrum of mycotoxins. Deciding which toxins, or combinations, are important can be difficult for the risk assessor. Finally, because mycotoxins often occur in basic commodities (cereals, nuts and fruits) and often are found in important export products, the health risk posed by exposure to the contaminant must be considered concurrently with the potential adverse impact on food availability and other economic impacts.
Complete removal of a mycotoxin hazard usually is not possible, so a risk management scheme must be developed. Risk management requires the evaluation of management alternatives, followed by the implementation of the best alternative and its monitoring and enforcement. Risk management strategies applied to mycotoxins include: (i) establishment of science-based regulatory limits, (ii) monitoring of food products prior to and during harvest/processing through HACCP protocols, (iii) screening and testing of commercial products, (iv) development of decontamination procedures, and (v) diversion of products to uses that are more tolerant of the mycotoxins present.
Thus, it is essential to provide developing countries with the technical and financial resources required to obtain the necessary data and to support or conduct risk analysis (Rosner, 1998; Piñeiro, 2004b). Areas in which substantial need for assistance have been detected include: (i) infrastructure and technology transfer to enable international quality risk assessment, (ii) obtaining the data required to support mycotoxin risk assessments, e.g. exposure assessment data, (iii) bridging gaps in quantitative risk assessment, and (iv) incorporating data from developing countries into international risk assessments and the international standards and guidelines that result. FAO has helped developing countries to: (i) develop their own risk management strategy and prevention and control procedures for mycotoxins through workshops and the provision of expert advice through technical cooperation projects (TCPs), (ii) prepare a monograph on mycotoxin prevention in conjunction with IARCs and WHO, and (iii) finalize a CD-ROM training package on Food Safety Risk Analysis that includes a framework and overview manual, a training module presentation, case studies in risk analysis and access to FAO/WHO resources related to food safety risk analysis (FAO/WHO, 2006).
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