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Issues: Haccp: a State-of-the-Art Approach to Food Safety

Technology designed to keep food safe in outer space may soon become standard here on Earth. The U.S. Food and Drug Administration (FDA), part of the Department of Health and Human Services, is adapting a food safety program, developed nearly 30 years ago for U.S. astronauts, for much of the U.S. food supply. The program for the astronauts focused on preventing hazards that could cause food-borne illnesses by applying science-based controls from raw materials to finished products. FDA's new system would do the same in an Earth-bound environment.

Traditionally, the U.S. food industry and its regulators have depended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food. This system, however, tends to be reactive, rather than preventive.

The new system is known as Hazard Analysis Critical Control Points, or HACCP. Many of its principles already are in place in the FDA-regulated low-acid canned food industry and have been incorporated into the most recent revision of FDA's Food Code. The Food Code serves as model legislation for state and territorial agencies that license and inspect food establishments in the United States.

In January 1994, FDA proposed regulations that would establish HACCP for the seafood industry. FDA issued its final rule on HACCP for seafood in December 1995, making the system effective in that industry.

A number of U.S. food companies already use the system in their manufacturing processes, and the U.S. Department of Agriculture (USDA) has proposed HACCP for the meat and poultry industry. (USDA regulates meat and poultry; FDA all other foods.) It is already in use in other countries, including Canada.

Recently, the FDA began steps that could result in this state-of-the-art food safety system becoming the standard for food safety in the United States. In an August 1994 advance notice of proposed rule-making, the FDA announced that it was considering developing HACCP regulations for many other segments of the U.S. food supply. These would include both domestic and imported foods. The agency asked for public comment on key issues, particularly from manufacturers that already use HACCP in their operations.

The FDA has invited food firms to participate in pilot HACCP programs to help the agency get additional information and experience on whether and how to design HACCP systems for foods other than seafood. Several firms have agreed to do so.

HACCP has been endorsed by the National Academy of Sciences, the Codex Alimentarius Commission (an international food standard-setting organization), and the National Advisory Committee on Microbiological Criteria for Foods.


HACCP involves seven steps:

1. Analyze hazards. Potential hazards associated with a food are identified. The hazard could be biological, such as a microbe; chemical, such as mercury; or physical, such as ground glass or metal.

2. Identify critical control points. These are points in a food's production -- from its raw state through processing and shipping, to consumption by the consumer -- at which a potential hazard can be controlled or eliminated. Examples are cooking, chilling, handling, cleaning, and storage.

3. Establish preventive measures with critical limits -- temperature and time -- for each control point. For a cooked food, for example, this might include setting the minimum cooking temperature and time required so as to ensure a safe product.

4. Establish procedures to monitor the control points. Such procedures might include determining how and by whom cooking time and temperature should be monitored.

5. Establish corrective actions to be taken when monitoring shows that a critical limit has not been met -- for example, reprocessing or disposing of food if the minimum cooking temperature is not met.

6. Establish effective record-keeping to document the HACCP system.

7. Establish procedures to verify that the system is working consistently -- for example, testing time-and-temperature recording devices to verify that a cooking unit is working properly.

Each of these steps would have to be backed by sound scientific knowledge: for example, published microbiological studies.


New challenges to the U.S. food supply prompted the FDA to consider adopting a HACCP-based food safety system. One of the most important challenges is the increasing number of new food pathogens. For example, between 1973 and 1988, bacteria not previously recognized as important causes of food-borne illness -- such as Escherichia coli 0157:H7 and Salmonella enteritidis -- became more widespread. There also is increasing public health concern about chemical contamination of food; for example, the effects of lead on the nervous system.

Another important factor is that the size of the food industry has grown tremendously -- in the amount of food manufactured domestically and in the number and kinds of foods imported to the U.S. market. At the same time, the FDA and state and local agencies have come under severe budget constraints in ensuring food safety.

HACCP offers a number of advantages over current procedures. Most importantly, HACCP:

-- Focuses on preventing hazards from contaminating food;

-- Is based on sound science;

-- Permits more efficient and effective government oversight, primarily because record-keeping allows investigators to see how well a firm is complying with food safety laws over a period of time rather than how well it is doing on any given day;

-- Places responsibility for ensuring food safety appropriately on the food manufacturer or distributor; and

-- Helps U.S. food companies compete more effectively in the world market.