Many food borne problems, including mycotoxin contamination, are increasing in incidence and emerging as major public health and economic issues because of reduced productivity, despite advances in control and prevention. Changing lifestyles, mass production of food, environmental contamination, travel, the globalization of the food trade and improved analytical techniques also influence food safety. The need for improved food safety occurs as regulatory resources for this purpose diminish and industry streamlines.

The HACCP approach appears to be a cost-effective food safety assurance system. It can be applied to all links in the food chain process and emphasizes prevention. Good Agricultural Practices (GAP) are the foundations on which HACCP is based. The application of HACCP to export trade has enormous benefits, in volume and in price, through opening markets and facilitating acceptance by buyers who place increased importance on food safety. The most important aspect of a HACCP program is the prevention of food associated diseases, including illnesses resulting from mycotoxins and other contaminants, which are particularly important in developing countries (FAO, 2001).

Whether mycotoxins are labeled biological or chemical hazards they fit in a HACCP program and appropriate Critical Control Points and their Critical Limits must be identified. Once the mycotoxin hazards are identified and the Critical Control Points determined, the Critical Limits can be set and the HACCP follows well-established steps. Associated relevant data are the established maximum limits, i.e., national or international legislation, guidelines and veterinary recommendations, or based on the knowledge of the food processor of the safety risk associated with each mycotoxin. Within the Codex system, the hazard identification step of the risk analysis process for mycotoxins and other chemical contaminants (industrial and environmental contaminants and naturally occurring toxicants such as mycotoxins) is initiated by CCFAC or member countries. JECFA's toxicological evaluation results in a Tolerable Intake or, when no threshold is thought to exist, e.g., for aflatox-ins, identification of a level that cannot be eliminated from a food without discarding that food altogether or severely compromising the ultimate availability of major food supplies.

HACCP was developed in the early 1970s to assure the safety of food products. Its introduction signaled a shift in emphasis from end-product testing to preventive control of hazards at all stages of food production. HACCP passes the responsibility for food safety to food processors that must, through a hazard analysis, identify potential sources of food safety hazards impacting their products, assess the relative risks of these hazards and specify steps that can reduce the potential risks. The processors determine in advance how they will react if the preventive steps fail and products or processes deviate from prescribed parameters. Continual monitoring, documentation, and improvement of the plan are essential elements of the HACCP system and serve as the basis for governmentally sponsored audits.

Mycotoxins are one of the conditional hazards that must be assessed on a situational basis. For example, deoxynivalenol contamination in grain depends on climatic and storage conditions. Monitoring the growing area and storage sites may be control points (CP) in a HACCP program. If monitoring indicates that deoxynivalenol levels in the incoming grain are a significant concern, then the food processor reassesses the likelihood of occurrence of this hazard and initiates CCP level controls as necessary and applies a full HACCP plan. HACCP protocols for aflatoxins, patulin and other trichothecene mycotoxins also require field and storage components in addition to process monitoring.

What is most important is that the HACCP Team has access to sufficient expertise to remain abreast of newly arising mycotoxin issues, e.g., toxicological evaluations, and that they can revise the HACCP protocols as necessary. Quantitative risk assessment is an area of particular concern since reliable data on mycotoxin no-observable effect levels (NOELs) or acceptable daily intake is scarce, especially for sensitive groups within both human and animal populations and for which active research is in progress.

CCFAC has developed a General Standard for Contaminants based on risk assessment and management that provides a process for incorporating exposure assessment into the standard setting process. In addition to its work on maximum levels, the Codex Alimenta-rius Commission also is developing Codes of Practice, so that Good or Improved Agricultural Practices can be used to decrease or eliminate mycotoxin contamination. HACCP principles are used to identify the major critical control points and to minimize the associated monitoring and remediation costs. The HACCP principles are introduced in the codes of practice to focus on major critical control points and provide a means of reducing the cost of such controls, while maintaining the required level of safety. FAO and WHO have developed guidelines for small and less-developed businesses (SLDBs).

The Food Quality and Standards Service (AGNS) of FAO has worked with government bodies and the food industry to implement HACCP. A major part of this program has been the development of tools and the conducting of training courses to strengthen national capacity in HACCP application and auditing. The FAO Manual "Food Quality and Safety

Systems - A training manual on food hygiene and the Hazard Analysis Critical Control Point (HACCP) system" serves as a reference for trainers and those with responsibility for HACCP plan development.

The FAO/IAEA Manual on the Application of the HACCP System in Mycotoxin Prevention and Control (FAO, 2001) provides examples in which the HACCP system is applied to mycotoxin contamination in food and feed in developing country scenarios. Workshops based on this manual are held in conjunction with on-site development of HACCP plans for mycotoxin prevention and control.

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