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D. A. KAUTTER, JR., Division of HACCP Programs, U.S. Food and Drug Administration, 200 C Street, S.W., Washington, DC 20204

The Hazard Analysis and Critical Control Point (HACCP) concept is a systematic approach to the identification and assessment of the risk of biological, chemical, and physical hazards from a particular food production process or practice and the control of those hazards. The United States Food and Drug Administration (FDA) is proposing to adopt regulations to ensure the safe and sanitary processing of fruit and vegetable juices and juice products. The proposed regulation, if adopted, will mandate the application of HACCP principles to the processing of these foods. FDA is proposing these regulations because there have been a number of outbreaks of illness, including some directly affecting children, associated with juice products and because a system of preventive control measures is the most effective and efficient way to ensure that these products will be safe. HACCP is a preventive system of hazard control that places the responsibility for identifying safety problems with the manufacturer. Use of the HACCP system means that a firm is engaged in continuous problem prevention and problem solving, rather than relying on facility inspections by regulatory agencies or consumer complaints to detect a loss of control. HACCP provides for real time monitoring to assess the effectiveness of control. A HACCP system put in place by a manufacturer for a particular facility is unique and reflects the type of juice, method of processing, packaging, the facility in which it is prepared, and the intended consumers. FDA has tentatively concluded that a preventive system, such as HACCP, appears to offer the most effective way to control the significant microbial hazards, along with other hazards, that have become a problem with juice.