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FOOD SAFETY

the FDA to inspect food manufacturing and processing facilities; required ingredients of nonstandard foods to be listed on labels; prohibited the sale of food prepared un- der unsanitary conditions; gave the FDA the authority to monitor animal drugs, feeds, and veterinary devices; and authorized mandatory standards for foods. Few laws have as great an impact on the life and health of Americans as does the Food, Drug, and Cosmetic Act. The overall function of the law was to prevent the distribution of harmful or deceptive food and drug products.

Seafood regulation came about on a voluntary basis with the Seafood Inspection Act of 1934. In the early 1930s, canned shrimp processors found that the FDA was seizing increasingly large amounts of their product be- cause of decomposition. Poor fishing practices and poorly supervised packing operations contributed greatly to the spoilage of shrimp products. As the canners could not themselves influence fishermen and packers to improve their handling of the product, they requested that Con- gress enact an inspection law. Packers of any seafood product could request an inspector to examine the premises, equipment, methods, containers, and materials used. If the inspection was favorable, they could use that information on their label. The new seafood inspection program had an almost immediate favorable effect on the canned seafood industry. Product quality improved and the industry was able to regain consumer confidence in its product.

In August 1996, Congress signed into law the Food Quality Protection Act (FQPA), fundamentally changing the way the Environmental Protection Agency (EPA) regulates pesticides used in the production of food. The FQPA sets special provisions concerning pesticide inges- tion for infants and children. Because little data exist on pesticide intake for children, an additional safety factor of up to tenfold, if necessary, is to be used. All existing tolerances are to be reviewed within ten years, and con- sideration of children’s special sensitivity and exposure to pesticide chemicals must be taken into account when set- ting tolerance levels. The EPA is now required to peri- odically review pesticide registrations, with a goal of establishing a fifteen-year cycle, to ensure that all pesti- cides meet updated safety standards. Most importantly, the new law establishes a health-based safety standard for pesticide residues in all foods. It uses “a reasonable cer- tainty that no harm” will result from all combined sources of exposure, including drinking water, as the general safety standard. This last facet of the FQPA is perhaps the most important because it eliminates the Delaney Clause of the Food, Drug, and Cosmetic Act, which pro- hibited the addition of any cancer-causing substance, no matter how small the amount, from being added to foods.

Hazard Analysis and Critical Control Points (HACCP)

In 1996 USDA issued its Pathogen Reduction: Hazard Analysis and Critical Control Points (HACCP) System

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rule. This rule requires that all 6,500 meat and poultry processing plants in the United States operate under a HACCP system. The FDA began its own HACCP reg- ulations with a 1995 rule that mandated seafood pro- cessing facilities must have in place a HACCP plan by 1997. The 1999 FDA Food Code incorporates HACCP principles and in 2001 the FDA mandated that all pro- ducers of fruit and vegetable juices use HACCP princi- ples by 2004.

Since the passage of the Meat Inspection Act in 1906, inspectors had visually examined and smelled meat to determine if it was safe or not. Such methods are not effective against the main threat to the safety of food to- day—bacteria so small that they cannot be seen or smelled. The failure of inspection methods in the United States came to the fore in 1993 when an outbreak of E. coli O157:H7 in hamburgers in the northwestern United States sickened over five hundred people and killed four. This provided the final push needed for the U.S. Department of Agriculture (USDA) to issue the Pathogen Reduction: Hazard Analysis and Critical Con- trol Points (HACCP) System rule in 1996. Under HACCP regulations, the food processing industry as- sumes primary responsibility for the safety of the food it produces. The government’s role is to verify that the industry is carrying out its responsibility, and to initiate appropriate regulatory action if necessary.

HACCP started from a National Aeronautics and Space Administration (NASA) food safety program in the 1960s. NASA needed to come as close as possible to 100 percent assurance that the foods astronauts consumed while on space missions would be free of bacterial or vi- ral pathogens. NASA, the U.S. Army Natick Laborato- ries, and the Pillsbury Company began to develop these first space foods. While Pillsbury researchers struggled with problems such as how to keep food from crumbling in zero gravity, they also realized that traditional food quality control programs would not provide the degree of safety desired. To produce the safest food possible, they needed to have control over their production process, the raw materials, the environment, and their employees. To provide this level of control, in 1971 they introduced the HACCP system.

A typical HACCP system identifies critical points during food processing where contamination is likely to occur.Then, controls can be put in place to focus on these critical areas. Traditionally, industry and regulators de- pended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food. This approach, however, tends to be reactive, rather than preventive. HACCP is a preventive, systematic approach to food safety, rather than a reactive method. One key advantage of HAACP is that it focuses on identifying and preventing hazards that may contaminate food, thereby allowing control to be exerted in the manufacturing phase, rather than after food is produced. HAACP per- mits more efficient and effective government regulation,

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