	While the Number of FDA Overseas Inspections Has Fluctuated, the Agency Has Opened Overseas Offices, and Has Piloted PREDICT

In 2008, FDA inspected 153 foreign food facilities out of an estimated  189,000 such facilities registered with FDA and estimated that it would  conduct 200 inspections in 2009 and 600 in 2010. In 2007, FDA inspected  95 facilities. In addition to having overseas offices assist FDA’s oversight of imported  food, the agency is developing PREDICT. PREDICT is intended to assist  FDA’s oversight of imported food and uses FDA-developed criteria to  estimate the risk of imported food shipments. PREDICT generates a numerical risk score for all FDA-regulated products. A 2007 pilot test of PREDICT in Los Angeles for seafood products  indicated that the system could enhance FDA’s risk-based import  screening efforts. FDA and Other Agencies Face Gaps in Enforcement That Undermine Efforts to Ensure the Safety of Imported Food

We identified specific gaps in enforcement that could allow violative food  products to enter U.S. commerce: (1) FDA’s limited authority to assess  civil penalties on certain violators; (2) lack of unique identifiers for firms  exporting FDA-regulated products; (3) lack of information-sharing  between agencies’ computer systems and (4) FDA’s not sharing product  distribution information during a recall. Information Is Not Shared between Computer Systems

When we issued our report in September 2009, we reported that CBP’s  computer system did not notify FDA’s or FSIS’s systems when imported  food shipments arrive at U.S. ports, which increases the risk that  potentially unsafe food may enter U.S. commerce, particularly at truck  ports. FDA Does Not Always Share Product Distribution Information During a Recall

One key issue of concern, according to officials we spoke with from  several states, is that FDA does not always share with states certain  distribution-related information, such as a recalling firm’s product  distribution lists, which impedes the states’ efforts to quickly remove  contaminated products from grocery stores and warehouses. Statutory Authorities We Identified Could Help FDA Oversee Food Safety

In our past work, we have pointed out that mandatory recall—the  authority to require a food company to recall a contaminated product— would help ensure that unsafe food does not remain in the food supply. We have noted that limitations in the FDA’s food recall authorities  heighten the risk that unsafe food will remain in the food supply and have  proposed that Congress consider giving FDA similar authorities. FDA Has Limited Oversight of Food Ingredients Determined to be Generally Recognized as Safe

We have reported that FDA should strengthen its oversight of food  ingredients determined to be generally recognized as safe (GRAS) for their  intended use. Currently, companies may conclude a substance is GRAS  without FDA’s approval or knowledge. We also recommended that, if  FDA determines that it does not have the authority to implement one or  more of our recommendations, the agency should seek the authority from  Congress. For example, we noted that FDA has identified a need for  explicit authority from Congress to issue regulations requiring preventive  controls (risk-based safety regulations) by firms producing foods that have  been associated with repeated instances of serious health problems or  death. FDA already has preventive regulations for seafood and juice,  which require firms to analyze safety hazards and implement plans to  address those hazards. FDA agreed with this recommendation and has sought  authority to issue additional preventive controls for high-risk foods. In conclusion, food imports from around the world constitute a substantial  and increasing volume of imported foods. Additional statutory authorities, such as  mandatory recall authority, could also help FDA oversee food safety.
Why GAO Did This Study

Food imported from around the world constitutes a substantial and increasing percentage of the U.S. food supply. Ensuring the safety of imported food challenges the Food and Drug Administration (FDA) to better target its resources on the foods posing the greatest risks to public health and to coordinate efforts with the Department of Homeland Security's Customs and Border Protection (CBP) so that unsafe food does not enter U.S. commerce. This testimony focuses on (1) FDA's overseas inspections, (2) identified gaps in agencies' enforcement efforts to ensure the safety of imported food, and (3) statutory authorities that GAO has identified that could help FDA's oversight of food safety. This testimony is principally based on GAO's September 2009 report, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food (GAO-09-873) and has been updated with information from FDA.

What GAO Found

While the number of FDA overseas inspections has fluctuated, FDA has opened up several overseas offices to address the safety of imported food at the point of origin, and is testing a computer-based system to target high-risk imports for additional inspection when they arrive at ports of entry. Specifically, in 2008, FDA inspected 153 foreign food facilities out of an estimated 189,000 such facilities registered with FDA; in 2007, FDA inspected 95 facilities. FDA estimated that it would conduct 200 inspections in 2009 and 600 in 2010. In addition, FDA opened offices in China, Costa Rica, and India and expects to open offices in Mexico and Chile and to post staff at European Union agencies. Furthermore, FDA's testing of a new computer screening system--the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT)--indicates that the system could enhance FDA's risk-based screening efforts at ports of entry, but the system is not yet fully operational. PREDICT is to generate a numerical risk score for all FDA-regulated products by analyzing importers' shipment information using sets of FDA-developed risk criteria and to target for inspection products that have a high risk score. GAO previously identified several gaps in enforcement that could allow food products that violate safety laws to enter U.S. commerce. For example, FDA has limited authority to assess penalties on importers who introduce such food products, and the lack of a unique identifier for firms exporting food products may allow contaminated food to evade FDA's review. In addition, FDA's and CBP's computer systems do not share information. FDA does not always share certain distribution-related information, such as a recalling firm's product distribution lists with states, which impedes states' efforts to quickly remove contaminated products from grocery stores and warehouses. GAO identified certain statutory authorities that could help FDA in its oversight of food safety. Specifically, GAO previously reported that FDA currently lacks mandatory recall authority for companies that do not voluntarily recall food products identified as unsafe. Limitations in FDA's food recall authorities heighten the risk that unsafe food will remain in the food supply. In addition, under current FDA regulations, companies may conclude a food ingredient is generally recognized as safe without FDA's approval or knowledge. GAO recommended that if FDA determines that it does not have the authority to implement one or more recommendations, the agency should seek the authority from Congress. Finally, GAO reported that FDA has identified a need for explicit authority from Congress to issue regulations requiring preventive controls by firms producing foods that have been associated with repeated instances of serious health problems or death. FDA already has preventive regulations for seafood and juice, which require firms to analyze safety hazards and implement plans to address those hazards.