Recent data from the Centers for Disease Control and Prevention show that one in six people in the United States suffers from food-borne illness each year. Over the past few years, high-profile outbreaks related to various foods, from spinach and peanut products to eggs, have underscored the need to make continuous improvements in food safety.
The Food Safety Modernization Act (FSMA) gives FDA a mandate to pursue a system that is based on science and addresses hazards from farm to table, putting greater emphasis on preventing food-borne illness. The reasoning is simple: The better the system handles producing, processing, transporting, and preparing foods, the safer our food supply will be.
Under the provisions of FSMA, companies will be required to develop and implement written food safety plans, FDA will have the authority to better respond and require recalls when food safety problems occur, and FDA will be able to better ensure that imported foods are as safe for consumers as foods produced in the U.S.
FDA Commissioner Margaret A. Hamburg, M.D., says the bill—which President Barack Obama signed into law on Jan. 4—lays the foundation for a prevention-based, 21st century food safety system that makes everyone in the global food chain responsible for safety.
“This law helps us take the critical steps toward strengthening the food safety system that is vital to the health and security of the American people,” Hamburg says.
The legislation, which FDA experts say transforms the food safety system, includes the following major provisions:
- 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.
- FDA must 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.
- FDA is directed to increase the frequency of inspections. High-risk domestic facilities must receive an initial inspection within the next five years and no less than every three years after that. During the next year, 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.
- 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 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.
While FDA is charged with regulating almost all food products, the legislation also recognizes that food safety is a responsibility shared among U.S., state, local, territorial, tribal, and foreign food safety agencies. This new legislation clearly endorses the efforts already underway among FDA and our regulatory partners toward creating a truly integrated food safety system.
Dr. Hamburg says the new law represents a critical step in strengthening the U.S. food safety system but acknowledges challenges in achieving full implementation as the legislation did not include sufficient fee resources to cover the costs of the new requirements. The commissioner says: "We ask Congress, industry and other stakeholders to work with us to ensure that FDA has sufficient fee resources to achieve our shared food safety and food defense goals."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Posted December 23, 2010