GAO Finds Gaps in FDA’s Scientific Research, Risk Analysis Hamper Its Food Safety Oversight

In a report to Congressional requestors, the Government Accountability Office found that the Food and Drug Agency has begun to take action to address weaknesses in its food safety scientific research and risk analysis, but that gaps remain which hamper its oversight.

(GAO’s report is based on a January 2010 to April 2010 audit of FDA which focused primarily on the agency’s: (i) incorporation of scientific and risk analysis into its oversight of the accuracy of food labeling, fresh produce, and the safety of dietary supplements; (ii) computer screening tool PREDICT (which stands for Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting); and (iii) progress in addressing selected recommendations identified by the Science Board.)

Lack of Info Hampers FDA Food Labeling, Produce, Supplement Oversight

GAO reports that FDA has taken certain limited steps to address previous criticism that gaps in scientific information limit the agency’s ability to oversee food labels, fresh produce, and dietary supplements. However, many concerns remain, such as:

Limited research on food label accuracy, etc. For food labels, GAO finds that FDA’s research on their accuracy, consumers’ perceptions, and other labeling options remains limited. For example, FDA has not conducted random sampling on food labeling claims since 1996; its research to determine the accuracy of nutrient information is limited and outdated; and the agency does not have empirical research on consumer perceptions to support enforcement against misleading food labels.

Insufficient research on fresh produce. FDA has recently explored the potential for it to access and use industry data and is in contact with other agencies regarding the use of produce testing data, however, it can be difficult and expensive to get other agencies to conduct research that meets FDA’s needs. This means that FDA’s efforts have only addressed some of its research needs and gaps remain that make it difficult to integrate science into a risk-based approach to oversee fresh produce.

Not enough information on supplements, mfrs. For dietary supplements, GAO states the FDA has not taken any action on its previous recommendations to address its lack of information on dietary supplements and their manufacturers which would help the agency in its assessment of risk. However, FDA notes that the pending food safety bills in Congress, if passed in their present form, would provide FDA with the authority to require dietary supplement companies to identify themselves through annual registration and require the submission of reports of all adverse events related to dietary supplements.

Risk-Based Import Screening Hampered by PREDICT’s Delay, Etc.

GAO states that PREDICT’s pilot tests have demonstrated the system’s potential to enhance FDA’s risk-based import screening effort, however technical difficulties are still delaying its rollout and FDA still does not have a finalized plan in place for evaluating the system’s effectiveness.

FDA noted in its comments to the GAO’s report that PREDICT is fully operational in the Los Angeles and New York districts, but due to technical problems FDA has not determined when the Seattle district will be deployed. In addition, FDA officials stated that a scheduled nationwide rollout this summer of PREDICT has been delayed primarily due to information technology infrastructure problems, such as server crashes and overloads, which are affecting FDA field data systems nationwide.

FDA officials have previously stated that the agency is working on a plan to evaluate PREDICT but that it is still in the draft stage.

(PREDICT is a computer screening tool which uses criteria - such as a product’s violative history, country of origin, foreign facility inspections, or lack of a track record - to estimate the risk of imported food shipments and help FDA determine whether a shipment needs further review.)

(See ITT’s Online Archives or 05/11/10, 04/20/10 and 10/19/09 news, 10051124, 10042021 and 09101915, for BP summaries of FDA testimony that it was working on a plan to evaluate PREDICT, the delayed rollout of PREDICT, and the GAO report which criticized the lack of a plan to measure PREDICT’s performance.)

House Committee on Science and Technology press release available here.