On Feb. 4, the Food and Drug Administration (FDA) announced a new approach to regulating imported products – including food and medical devices – to enhance the agency's ability to respond to the increased globalization of commerce. The new risk-based approach to inspections and product tracking will be in place nationally in 2010.

Dr. Margaret Hamburg, FDA's commissioner, announced the new approach in a speech at the Center for Strategic and International Studies, a Washington, DC, policy and research organization. The new safety strategy shifts the agency from one that reacted to problems after they occurred to one that tries to prevent product safety problems.

During the Bush administration, FDA was criticized for its inability to respond to crises afflicting the public because the number of imported products outstripped the agency's ability and willingness to protect the public. Although the Obama administration has increased the budget for FDA, "FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities. This year, we expect that nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry. Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that," according to Hamburg's speech.

FDA has fewer than 500 inspectors to handle the 20 million shipments. As a result, the agency inspects less than one percent of imported products and only about eight percent of foreign drug manufacturers, Hamburg said. FDA has begun to shift its approach to the growing burden it faces by, for example, setting a goal of dramatically increasing inspections of overseas food facilities and hiring new inspectors.

The plan that Hamburg described in her speech has several dimensions. First, FDA's overall strategy to import safety is changing. Hamburg described it this way in her speech:

To assure the safety of imported products and fulfill our public health mission in a global age, the FDA must adopt a new approach … an approach that takes into account the entire supply chain and its complexity; and an approach that will address product safety by preventing problems at every point along the global supply chain … from the raw ingredients … through production … and distribution … all the way to U.S. consumers.

Second, FDA has developed several new objectives. The agency is focusing on point of production issues by working with manufacturers, suppliers, and foreign governments to create collaborative networks and build the regulatory capacity of countries without well established regulatory infrastructures. According to Hamburg, for example, "We now have permanent FDA offices in Beijing, Shanghai and Guangzhou, China, in New Delhi and Mumbai, India, in San Jose, Costa Rica, Mexico City, Santiago, Chile, and—soon—Amman, Jordan." FDA now has more than 30 agreements with countries with more sophisticated regulatory systems to share information and provide inspection data.

FDA also intends to hold importing companies responsible for their supply chains by requiring them "to effectively demonstrate that safety, quality and compliance with international and U.S. standards are built into every component of every product and every step of the production process," Hamburg said.

To maximize its inspection resources, Hamburg announced that FDA is putting in place a new system called PREDICT (the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting). This new risk assessment tool will allow the agency to rank the public health risks posed by various products so FDA can target more carefully its inspections to those products. PREDICT has been used in Los Angeles and is being implemented in New York. Hamburg said FDA intends to have it implemented nationwide by the end of summer.

According to materials prepared for industry and available on FDA's website, the new ranking tool will use compliance histories, shipper and producer information, inspection results, and other entry data to identify which products pose fewer risks, thus allowing goods to be imported more quickly. If sufficient information is not available, or if anomalies appear that could indicate fraud, FDA will require additional information before products are released for shipment throughout the U.S.

The shift by FDA to a preventative approach is consistent with food safety legislation Congress is debating. The Food Safety Enhancement Act of 2009 (H.R. 2749) establishes risk-based preventative controls and hazard analyses while giving FDA expanded authority to set high-risk triggers and issue regulations in a range of food safety areas. The House passed the bill in 2009 and referred it to the Senate, which has not acted.