An HTML version of this document is available at http://vm.cfsan.fda.gov/~lrd/haccp-re.html ------------------------------------------------------------ HHS Press Release: January 1994 HHS NEWS U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES P94-1 Food and Drug Administration FOR IMMEDIATE RELEASE Brad Stone (202) 205-4102 Jan. 21, 1994 (703) 204-4497 Health and Human Services Secretary Donna E. Shalala today announced a major new food safety initiative in which the Food and Drug Administration will require the seafood industry to establish safety controls subject to regulatory oversight and review. In a related move, the FDA issued its updated Model Food Code designed to help state and local governments prevent foodborne diseases. The Model Food Code, which incorporates the principles of mandatory safety controls, outlines the practices for safe food handling at the retail level. "The truth is, most cases of food-borne illnesses are preventable," Shalala said. "And it's our job to prevent them. That's why we are strengthening our seafood safety program." The seafood safety regulations are based on the principles of the system known as Hazard Analysis Critical Control Point (HACCP). The system calls for a science-based analysis of potential hazards, determination of where the hazards can occur in processing, and institution of preventive measures to prevent problems and corrective actions if they do occur. Detailed HACCP record-keeping then allows government regulators to monitor closely how well firms are performing on a continuing basis. "This system of mandatory controls draws its strength from one simple principle: the notion that the best way to provide safe, high-quality food is to build safety in during processing," said Food and Drugs Commissioner David A. Kessler, M.D. "Today, we inspect for safety after the fact. That's simply not good enough. We need to approach food safety by preventing problems up from." The comprehensive mandatory controls that will be required under FDA's HACCP proposal will be monitored under current FDA surveillance and inspection activities directed at seafood production. All seafood processors, packers and warehouses will be included. Each will be required to adopt a HACCP plan appropriate to its business, monitor it and keep records that will be inspected regularly by FDA and state inspectors. Under this system, for example, firms will have to document that fish and shellfish have not been made unsafe by pollution or natural toxins in the water. Companies will have to verify that ready-to-eat seafood has been cooked to a safe temperature, that safeguards have been taken against cross-contamination between cooked and raw seafood, and that finished products are held at proper temperature. The rules will apply equally to domestic and imported products. Many other countries are also considering similar systems. Under today's proposals, companies would have one year after publication of final regulations to implement fully their HACCP programs. FDA has also begun working with other segments of the food industry, state officials and consumer groups to consider whether preventive food safety measures can be applied to other foods. Like the seafood rules, such measures would have to be tailored to the nature of potential hazards for each food and to the operations of each affected industry. Among the topics to be addressed are where food safety hazards exist, at what points they could be minimized eliminated, methods to monitor compliance and the laws and regulations of other countries. The announcement of the updated Model Food Code is the culmination of a cooperative effort among federal, state and local officials, food industries and consumer groups. It provides a model set of regulations that can be used for retail food establishments such as restaurants, institutions like nursing homes, grocery stores and vending operations. Standards include items like cooking times and temperatures, refrigeration temperatures, and storage requirements for many types of foods. FDA will hold public meetings in nine cities in the next eight weeks to solicit public comments about the seafood safety proposal. Comments on the seafood proposal will be accepted for 90 days after publication in the Federal Register. Written comments should cite docket number 93N-0195 and be sent to: Food and Drug Administration, Dockets Management Branch, HFA-305, Room 1-23, 12420 Parklawn Dr., Rockville, MD 20857 FDA is one of eight Public Health Service agencies within HHS.