The U.S. Government Accountability Office on May 6 released a report entitled "Food Safety: FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities."

We all know that FDA doesn't inspect a ton of foreign facilities but consider this stunning statistic: in 2008, the FDA inspected 153 foreign food facilities out of an estimated 189,000 such facilities registered with FDA.

From that statistic alone, the job that FDA faces in imposing "preventive controls" on foreign food facilities is staggering, not to mention the issue of "unique identifiers" related to product traceback. 

Reprinted below are excerpts from the GAO report:


Thursday, May 6, 2010:

Food Safety:

FDA Could Strengthen Oversight of Imported Food by Improving  Enforcement and Seeking Additional Authorities:

Statement of Lisa Shames, Director:
Natural Resources and Environment:

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 the food supply. 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 the 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.

What GAO Recommends:

GAO recommended that FDA explore a unique identifier for firms, among other things. GAO also recommended FDA seek statutory authorities, such as for recalls and preventive controls. FDA agreed with these recommendations and has sought authorities.