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Management Issue 11:
Ensuring the Safety of the Nation's Food Supply

Why This Is a Challenge

Pallets of food in a warehouse

CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of food-borne diseases. FDA is responsible for ensuring the safety of much of the Nation's food supply. During a food emergency, FDA is responsible for finding the contamination source and overseeing the removal by manufacturers of these products from the market. Yet, recent OIG reports found that food recall inefficiencies, inadequate food facility inspections, and recordkeeping issues impair FDA's ability to effectively resolve food emergencies. These challenges may be exacerbated in the case of imported foods, which have increased significantly in volume and variety in recent years.

In reviews of food safety recalls, we found that FDA often did not follow its own procedures for ensuring that the recall process operated efficiently and effectively. Further, FDA's procedures for monitoring recalls were not always adequate.

Our work has also found that FDA conducts food facility inspections infrequently - many food facilities went 5 years or longer without an FDA inspection. Furthermore, FDA took action against less than half of food facilities after the agency found conditions that warranted its most severe inspection classification. FDA relies increasingly upon States to conduct food facility inspections under contract; OIG is examining the effectiveness of FDA's oversight of these inspections.

Food facilities' failure to comply with FDA's recordkeeping requirements impedes the Department's ability to ensure the safety of the Nation's food supply. We found that 59 percent of selected food facilities did not comply with FDA's recordkeeping requirements. We also found that 5 percent failed to register with FDA as required. Of those that did register, almost half failed to provide accurate and complete information.

The Food Safety Modernization Act (FSMA), signed into law in January 2011, provides FDA important new authorities to better protect the Nation's food supply. However, challenges exist in implementing these new authorities.

Progress in Addressing the Challenge

The Department has made progress in addressing the safety of imported food. FDA opened field offices in China, India, and Costa Rica to conduct more inspections and work with local officials to improve the safety of foods exported to the United States. FDA expanded its inspections capacity by increasing its staff by more than 700 investigators between FY 2007 and FY 2009 and by an additional 274 staff in FY 2010. FDA also deployed the PREDICT system, which is a risk-based screening tool for imported foods. As of August 23, 2011, 11 of 16 import districts were using the PREDICT screening tool. In September 2009, FDA required food facilities to report to a new registry all instances in which a food might cause serious health consequences and to investigate the causes of any adulteration reported. FDA has implemented, which provides food safety information for consumers. FDA is also developing the Petnet system, which will provide information on pet item recalls.

FDA has also made progress streamlining its jurisdiction by increasing its interagency coordination. For example, FDA partners with the National Oceanic and Atmospheric Administration to develop, validate, and use new chemical tests to detect oil residues and dispersants in seafood. Additionally, FDA partnered with the U.S. Department of Agriculture, States, and localities to improve the food safety system, including implementing a national egg inspection plan, which has a goal of inspecting 600 of the Nation's largest egg facilities by the end of calendar year 2011.

What Needs To Be Done

The Department and FDA should act quickly to implement FSMA to better protect the Nation's food supply. FSMA addresses many of OIG's recommendations; however we continue to recommend that FDA vigorously use its new authorities to remedy identified weaknesses in its inspections and recall procedures. FDA should also ensure that States properly conduct contracted food facility inspections.

OIG will continue to oversee the Department's management of food safety issues. In ongoing work, OIG is examining food facility compliance with requirements of FDA's Reportable Food Registry, FDA oversight and operations related to imported pet food and feed products, and the extent of FDA's testing of human food for contamination.

Key OIG Resources

Management Issue 12: Oversight of the Approval, Safety, and Marketing of Drugs and Devices

Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201