FDA's Food Safety Program Gets Real Teeth

For many years, the role of the Food and Drug Administration (FDA) in the U.S. food safety system was reactive, rather than proactive. When a tainted food product slipped by or otherwise avoided detection by the U.S. Department of Agriculture (USDA), the FDA was largely responsible for issuing and enforcing recalls of the product. The Food Safety Modernization Act of 2010 (FSMA), signed into law by President Obama in January 2011, placed the FDA's food safety focus on prevention - ensuring that unsafe foods never make it into stores, restaurants and school cafeterias in the first place.

The Food Safety Modernization Act covers all domestic and imported foods, beverages and food ingredients except meat and poultry, which are regulated by the U.S. Department of Agriculture.

"These new authorities are critical for the law's success," said Michael R. Taylor, FDA's deputy commissioner for foods in a press release. "They give the food companies strong additional incentives for keeping their products safe, and that helps us achieve the new law's goal, which is to protect consumers from unsafe food."

According to the Centers for Disease Control and Prevention, foodborne illness strikes 48 million Americans every year, hospitalizing more than 100,000 and killing thousands.

Impetus for passage of the Food Safety Modernization Act of 2010 came largely from public reaction to the massive recalls of tainted spinach, tomatoes and peanut butter required between 2006 and 2009. In March 2009, President Obama reacted to the recalls by calling the U.S. food safety system an "unacceptable hazard to public health," and creating blue ribbon commission that ultimately created the FSMA.

Prevention Rather than Reaction

Through provisions in the Food Safety Modernization Act (FSMA), the FDA is required by Congress to apply "comprehensive, prevention-based controls" across all aspects of the U.S. food supply.

• Under the FSMA, the FDA's role in the food safety system shifts from one of responding to outbreaks of contaminated or misbranded food-related illnesses to preventing those outbreaks in the first place. FMSA requires food processing and distribution facilities to create and maintain, subject to FDA approval, a detailed evaluation of contamination hazards in their operation, as well as contamination prevention and corrective action plans.

• The FSMA also requires the FDA to establish and apply new "science-based standards" to be followed by producers and distributors of fruits and vegetables, standards that did not exist at the time of the 2006 raw spinach or the 2008 tomato recalls.

• For the first time, the FDA has the authority to hold food companies accountable for preventing contamination of their products.

"The idea of prevention is not new," said FDA commissioner Dr. Margaret A. Hamburg at the FSMA signing ceremony. "FDA has established prevention-oriented standards and rules for seafood, juice, and eggs, as has the U.S. Department of Agriculture for meat and poultry, and many in the food industry have pioneered 'best practices' for prevention. What's new is the recognition that, for all the strengths of the American food system, a breakdown at any point on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry."

New Inspection Powers

The FSMA gives FDA more authority to gain access to food company records related to potentially hazardous or contaminated foods. In addition, the FDA can now inspect company records related to any other food it believes may be similarly affected, whether it has be found to be contaminated or not.

Imported Food Safety

The legislation takes steps to close one of the most glaring gaps in the U.S. food safety system, oversight and control of imported foods. According to the USDA, an estimated 15% of the U.S. food supply, including 60% of fresh fruits and vegetables and 80% of seafood enters the United States from foreign countries each year.

• The FSMA requires all food importers to implement a Foreign Supplier Verification Program, requiring strict item-by-item certification of product safety.

• The FDA can now deny admission into the U.S. of any imported food if the foreign food producer or country refuses to allow the FDA to inspect its products.

• FDA is now authorized to require certification that imported foods and beverages are in compliance with all food safety requirements.

• Food importers who apply additional food safety measures as approved by the FDA may get expedited review and inspection of their shipments.

Enhanced Response to Outbreaks

Under the FMSA, the FDA, for the first time, has the authority to declare immediate mandatory recalls of food products. Prior to enactment of the FSMA, the FDA could only request that food producers issue voluntary recalls.