The Food Safety Modernization Act, signed into law by President Obama on January 4, 2011, has ushered in a new era of food-safety regulation. The $1.4 billion bill—the first major reform of the nation’s food safety laws since the Great Depression—mainly expands the reach and regulatory powers of the Food and Drug Administration (FDA).
“The biggest change is the focus on prevention,” says Douglas Karas, a spokesperson for the FDA. The new legislation requires that food companies take preventive steps to avoid food contamination. They will now have to identify the critical points in their supply chain where the food they’re handling could become contaminated and then implement procedures to prevent that contamination.
The driving forces behind the Act are increased consumer awareness and globalization. High-profile outbreaks of food poisoning in recent years have shaken public confidence in the nation’s food supply. The Centers for Disease Control estimates that there are 48 million cases of food-borne illnesses in the United States each year, resulting in 128,000 hospitalizations and over 3,000 deaths. Rapid growth of imports and food ingredients from countries where safety standards are lacking has made the food supply chain more vulnerable to outbreaks of food-borne illness. Today, imports account for 15 percent of the U.S. food supply, including 80 percent of the seafood Americans consume and 50 percent to 60 percent of the fresh produce.
The nature of today’s food supply chain means contamination can turn up in more products, more quickly than in the past, causing outbreaks that affect large numbers of people. To combat this problem, the FDA will increase the frequency of inspections. High-risk domestic facilities will receive an initial inspection within the next five years and no less than every three years after that, while low-risk facilities will be visited within the next seven years. The law also significantly enhances FDA’s ability to achieve greater oversight of the millions of food products coming into the U.S. from other countries each year.
FDA experts say that the legislation, which has been supported by most of the industry trade associations, including the Food Marketing Institute (FMI) and Grocery Manufacturers of America (GMA), transforms the food safety system. The major provisions include:
- Food facilities must have a written preventive controls plan that spells out the possible problems that could affect the safety of their products. This plan would outline steps that a food facility would take to prevent or significantly minimize the likelihood of those problems occurring.
- The FDA will establish science-based standards for the safe production and harvesting of fruits and vegetables. These standards must consider not only man-made risks to fresh produce safety, but also naturally-occurring hazards—such as those posed by the soil, animals, and water in the growing area.
- The FDA is directed to increase the frequency of inspections. During the next year, the FDA must inspect at least 600 foreign food facilities and double the number of those inspections every year for the next five years. With the availability of resources, FDA will build the inspection capacity to meet these important goals.
- The FDA is authorized to mandate a recall of unsafe food if the food company fails to do it voluntarily. The law also provides a more flexible standard for administrative detention (the procedure FDA uses to keep suspect food from being moved); allows the FDA to suspend the registration of a food facility associated with unsafe food, thereby preventing it from distributing food; and directs the agency to improve its ability to track both domestic and imported foods.
With an implementation timeline in the works, food distributors are left to wonder when—and how—the new legislation will impact them.