Analytical results and laboratory quality assurance

Reliable analytical results require the systematic application of quality assurance measures, including documentation, trained personnel, appropriate and calibrated instrumentation, validated methods and adequate laboratory infrastructure. Method performance is demonstrated through proficiency or interlaboratory studies, use of reference materials, and statistical evaluation (repeatability, reproducibility values and accuracy and precision control charts). Adequate quality assurance procedures enable both the identification of problems and their correction.

In June 1997 Codex Alimentarius (2003d) recommended that laboratories responsible for control of export and import foods comply with ISO 17025 "General Requirements for the Competence of Calibration and Testing Laboratories", and ultimately be accredited by a certified body. In addition, the only methods of analysis endorsed by the Codex Committee on Methods of Analysis and Sampling (CX/MAS) will only be validated methods for ISO 17025 accredited laboratories. Directive 93/99/EEC of the European Union (European Commission, 2002) also requires food control laboratories to be formally accredited to an internationally recognized standard such as ISO 17025. Thus, both governmental and industrial laboratories must have analytical capabilities with quality assurance systems in place.

The implementation of international standards/guidelines and recommendations under the SPS Agreement enforced by WTO, requires suitable laboratory facilities, adequately trained personnel, and, by implication, continuous training in quality assurance for mycotoxin analysis. National food control systems should improve food safety and stimulate international trade by employing efficient methods for detecting, quantifying and certifying mycotoxins in food. Strengthening the analytical capabilities of laboratories in developing countries to enable effective monitoring of the mycotoxin content of food should help overcome non-tariff trade barriers. Research data are needed on the effectiveness of various analytical methods used to monitor mycotoxin contamination to identify cost-effective validated procedures (Pineiro, 2000).

Good, reliable data also are needed to perform risk assessments. Reliable, sensitive, accurate, precise methods of analysis and sampling, leading to internationally accepted analytical results are fundamental to international trade under the SPS and TBT agreements of the WTO. Mycotoxins often are regulated food contaminants that become non-tariff trade barriers. Laboratories in developing countries must implement quality assurance systems according to ISO 17025 and Good Laboratory Practices to demonstrate their analytical capability. FAO assists national food control laboratories in preparing for accreditation and in validating methods for detecting and quantifying mycotoxins. In addition to validated methods, internal quality control procedures must be implemented and document participation in proficiency testing and proper use of reference materials. Quality assurances programs, with their method validation procedures, interlaboratory schemes and accreditation awards provide evidence of consistent satisfactory performance.

Food safety is a shared responsibility among government, industry and consumers. Most governments have enacted legislation to assure the safety of the food supply, and over 100 countries regulate mycotoxin levels (FAO, 2004). Effective enforcement of mycotoxin legislation requires administration/policy and regulation, inspection and sampling, and analytical services. Analytical results submitted by an accredited laboratory are considered prima facie evidence of violations and also are necessary for health-oriented, population-based monitoring.

Risk analysis is dependent on adequate and reliable monitoring programs to provide reliable data for calculating exposure assessments (for IARC, JECFA). In the absence of reliable data and scientific consensus, there often is disagreement between importing and exporting countries, which each may set regulatory levels based on their perceptions of what is achievable. National limits for aflatoxins often are determined by a country's trading position (exporter/importer), by climate and by other non-risk factors. The resulting inconsistencies have incurred considerable economic costs, the rejection and downgrading of food shipments, increased expenses in quality assurance (QA) programs, and significant trade problems (Pitt, 1995; Rosner, 1998).

FAO's assistance in laboratory performance and analytical quality assurance are exemplified by two sub-regional projects to strengthen the InterAmerican Network of Food Analytical Laboratories (INFAL/RILAA) which began in 2004 and benefits nineteen coun tries from South and Central America and the Caribbean. The project's goal is to ensure that laboratories provide reliable analytical results for the national food control system and that they can certify food imports and exports. The participating laboratories strive for product conformity assessment through harmonization or the establishment of internationally equivalent analytical results. The main activities undertaken were training and the development of national action plans for strengthening the technical, analytical and administrative skills necessary for laboratory analyses of microbiological and chemical contaminants.

FAO also is assisting developing countries worldwide in the implementation of laboratory quality assurance measures and in generating data by using accepted method validation criteria through TCPs and training workshops, e.g., Regional Training Courses on Development of Quality Assurance for Mycotoxin Analysis. These courses develop quality assurance systems for mycotoxin analysis of food and train participants in the establishment and implementation of an analytical quality system that complies with ISO Standard 17025, making accreditation possible. The FAO/IAEA CRP on mycotoxin methods, also provides support to countries worldwide, and has implemented a coordinated research project on mycotoxin methodology that involves development and validation of mycotoxin methods for use in developing countries.

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