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Date: December 5, 1995                       
FOR IMMEDIATE RELEASE
Contact:  Judith Foulke (202) 205-4144

The new Food and Drug Administration regulations represent a revolution in the way food is protected. The regulations -- based on principles of a system called Hazard Analysis Critical Control Point (HACCP) -- replace the approach adopted in the early 1900s that addressed safety problems after the fact with new procedures under which food processors will take greater responsibility for preparing safe food, and government and industry will work more closely together to protect public health.

It is estimated that these regulations will prevent 20,000 to 60,000 seafood poisonings a year, which cost consumers up to $116 million annually. The regulations lead the way toward a 21st century food safety system; they will be followed next year by Department of Agriculture rules for meat and poultry and in subsequent years by additional FDA regulations covering other segments of the food supply.

"Many Americans are making an effort to eat healthier and are including seafood in their diet," said Health and Human Services Secretary Donna E. Shalala. "A system that will ensure the safety of seafood products, regardless of what country or environment they come from, is a high public health priority. These changes also represent another step in the Clinton Administration's continuing effort to protect the public health through smart, state-of-the-art regulations."

The key HACCP components of the system are identification of potential problems that could make seafood hazardous; establishment and monitoring of targeted control points to minimize such risks; and keeping a record of the results.

Under the FDA rule, seafood processors will have to identify hazards that, without preventive controls, are reasonably likely to affect the safety of the products. If at least one such hazard can be identified, the firm will be required to adopt and implement an appropriate HACCP plan. For example, a highly mechanized processing line would be checked regularly for metal fragments in the food and records kept of those checks. In addition to helping ensure that the food is free of such contaminants, this process also helps manufacturers who subsequently have problems with their food determine how and when those problems could have occurred.

Seafood processors using the HACCP system will continue to be monitored under FDA surveillance and inspection programs. HACCP record keeping will enable FDA regulators to monitor product safety more closely and on a more continuous basis than through spot checks.

"Our safety inspections should focus on preventing problems rather than chasing the horses after they're out of the barn," said FDA Commissioner David A. Kessler, M.D. "HACCP is a system that will make that possible."

While the HACCP rules do not apply to fishing vessels or transporters, processors of imported as well as domestic seafood must take responsibility for incoming materials. If the supplier does not provide satisfactory information about the area where the fish were caught or how they were handled, the HACCP plan will strengthen the processor's position in refusing to accept the shipment.

The HACCP regulations contain special provisions to protect the safety of certain types of products. For instance, processors of raw molluscan shellfish (oysters, clams and mussels) must specify in their plans, among other things, that they will accept only molluscan shellfish that have been harvested from approved waters. In the case of smoked fish, HACCP controls call for procedures that will provide safety from Clostridium botulinum toxin through the shelf life of the product.

Retail seafood operations, while exempt from the FDA rule, are regulated by state and/or local authorities with training and other technical assistance from FDA.

The HACCP regulations for seafood processors will be published in the Federal Register shortly. The rule will be fully implemented over the next two years and the agency anticipates being able to perform HACCP inspections beginning in 1996.