HACCP: Industry versus Government

Few initiatives in the recent history of food safety regulation have approached the significance of the Hazard Analysis and Critical Control Point (HACCP) system. The HACCP concept is simple; it is a systematic, proactive approach to preventing food safety hazards by focusing resources at those points at which food safety hazards can be controlled, an alternative to generally reactive end-product testing. By identifying the hazards associated with a product and determining the points in the process or practice where these hazards can be managed, the control, monitoring and verification of the process can assure that potential hazards are dealt with before a product enters distribution (NACMCF, 1993). Industry and regulatory sectors alike have endorsed the use of HACCP by the food industry. Despite the simplicity of the HACCP concept, however, its application is complex. HACCP not only requires an analysis of every product and process, its implementation by a manufacturer involves a significant investment in education and training, record keeping and process verification. As regulators ponder the most effective application of the HACCP concept to their initiatives, it is inevitable that the relationship between the regulators and the regulated industry will change, and questions have arisen as to what and how fundamental such changes will be. Reflecting on his own country’s experience, an Australian government representative noted that Australia’s application of HACCP has brought about a massive culture change, making a communications strategy a necessity (USDA, 1994). The history of HACCP dates back to the early 1960’s, as a response to food safety requirements imposed by NASA for foods produced for manned space flights (FDA, 1994a; Stevenson, 1995). A case of foodborne illness in a space capsule would have been catastrophic, and so the agency was concerned that the foods used in such flights had an absolute assurance of the absence of pathogens and biological toxins. The Pillsbury company realized the limitations of end-product testing and its inability to assure that a product was free of pathogens. As an alternative approach, Pillsbury adapted the “Modes of Failure” concept developed by the U.S. Army Natick Laboratories in the production of foods. The concept relied on the gathering of knowledge and experience about the food product or process and the use of this information to predict what problems might occur, and how and where they might occur in the process. It would then be possible to determine points in the process at which specific measurements or observations could be made to indicate whether the process was under control. If control was lost at these points, a food safety hazard might potentially occur. The system was termed the HACCP or Hazard Analysis and Critical Control Point system (Stevenson, 1995). HACCP was first formally presented at the 1971 National Conference on Food Protection (APHA, 1972), and was established by the FDA, first as a strategy for the control of microbiological hazards in the mushroom canning industry, and later for control in all low-acid canned foods (FDA, 1973; NRC, 1985). In the FDA strategy, companies producing a given product would apply the HACCP system, identifying appropriate critical control points and monitoring procedures. Regulatory inspectors would review plant control protocols to determine the proper identification of critical control points and the establishment of appropriate monitoring systems. Once protocols were reviewed and the program implemented, the role of the regulator would shift to reviewing the results of monitoring to determine that the foods were being produced under conditions of adequate microbiological control (NRC, 1985). During the 1970’s, many food processors attempted to implement HACCP programs in their facilities to assure product safety. Most of these programs were discontinued because they did not achieve a quantifiable objective (NFPA, 1993). Except for the use of HACCP for low-acid canned *T.C. Jackson, Institute of Food Science and Engineering Center for Food Safety, The Texas A&M University System.