GAO Urges Stronger FDA Food Oversight, Passage of Food Safety Bill

In testimony before a House Subcommittee¹, the Government Accountability Office recommends that the Food and Drug Administration strengthen its oversight of imported food by improving enforcement and seeking additional authorities.

The GAO also notes that many of its recommendations are addressed in the House-passed food safety bill (H.R. 2749), which is currently being considered by the Senate.²

(Note that the testimony is based largely on previous GAO reports. See BP summaries of these reports below.)

FDA Has Limited Penalty Authority, Gaps in Its Oversight

The GAO states that the following factors are evidence of the need for stronger FDA oversight and authority over imported food:

Limited penalty authority, no unique identifiers. FDA has limited authority to assess penalties on importers who introduce violative food products, and the lack of a unique identifier for firms importing food products may allow contaminated food to evade FDA review.

PREDICT full roll-out delayed. Even though FDA testing of 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, it is not yet fully operational nationwide due to technical problems, and its full roll-out has been delayed. (See ITT’s Online Archives or 04/20/10 news, 10042021, for BP summary of the suspended rollout of PREDICT.)

Weakness with GRAS ingredients. Under current FDA regulations, companies may conclude a food ingredient is generally recognized as safe (GRAS) without FDA’s approval or knowledge.

Lack of info. sharing. According to GAO, FDA and CBP’s computer systems do not share information. In addition, 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.

Fragmented oversight. There are several Federal agencies involved in imported food safety oversight, including FDA, U.S. Customs and Border Protection (CBP), and the Food Safety and Inspection Service (FSIS). In addition, food safety responsibility is further divided among the 50 states, which may have their own statutes, regulations, and agencies for regulating and inspecting the safety and quality of food products.

FDA Needs Explicit Controls Over High-Risk Food, Mandatory Recall Authority

The GAO recommends that FDA seek additional authorities, such more explicit authority to create preventive controls for high-risk foods and mandatory recall authority. It also recommends that it better coordinate efforts with CBP so that unsafe food does not enter U.S. commerce. According to GAO, FDA agreed with these recommendations.

Pending Food Safety Bill Addresses Many GAO Recommendations

GAO notes that it has made many of the same recommendations as those contained in H.R. 2749, the Food Safety Bill that the House passed in July 2009. According to GAO, the House bill would require importers to register annually with FDA and to submit an appropriate unique facility identifier as a condition of such registration. The bill would also authorize FDA to issue a mandatory recall of foods that may cause serious adverse health consequences or death to humans or animals and would expand the agency’s authority to assess criminal and civil penalties.

¹The Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.

²See ITT’s Online Archives or 09/01/09, 08/25/09, 08/12/09, 08/10/09 and 08/04/09 news, 09090120, 09082510, 09081205, 09081015 and 09080415, for BP summaries of House-passed H.R. 2749’s provisions on: ceramicware, Bisphenol A, & infant formula; facilities and exporting; food tracing; broker registration and new reasons to detain food; and importer registration, certification for high-risk imports, and increased inspections.

(See ITT’s Online Archives or 05/26/10, 03/16/10 11/19/09 news, 10052665, 10031640, 09101915, for BP summaries of previous GAO reports on FDA oversight of food safety.)

(GAO-10-699T, dated 05/06/10)