Industry officials with whom we spoke informed us that FDA’s and FSIS’ actions did not, to their knowledge, result in the widespread destruction of beef, pork, poultry, or fish products, but some eggs had to be destroyed. One-Part-Per-Trillion Dioxin Concentration Level Chosen to Distinguish Elevated Dioxin Levels From Normal Background Levels

FDA and FSIS requested the producers and processors to halt the distribution of the affected food products with dioxin levels above one part per trillion because of their concern about the potential risk to human health. Although scientists have not yet determined the level at which dioxin may pose a risk to human health, the agencies chose a level of dioxin that is somewhat higher than the background level in food products to distinguish the food products affected by the use of adulterated feed from other food products. According to these officials, FDA did not provide any evidence to support the decision to request that products with a dioxin level of one part per trillion be halted. In addition, the producers expressed concern that the agencies did not allow enough time for them to comply with the requirements. EPA, FSIS, and FDA Cooperated to Identify the Source of the Dioxin Contamination and to Decide on the Actions Necessary to Address Potential Health Risk

Once EPA confirmed that the dioxin levels in the poultry samples were higher than naturally occurring background levels, officials from FSIS and FDA were included in the investigation into the source of the dioxin. The Current Food Safety System Resulted in Inefficiencies and Hardships for Some Producers and Processors

The agencies involved in addressing the dioxin incident had to overcome the inherent inefficiencies associated with the current food safety system, in which responsibility for ensuring food safety is spread among several agencies. As we have reported on numerous occasions, this fragmented food safety system necessitates extensive coordination efforts to minimize wasteful duplication of effort, prevent gaps in regulatory coverage, and avoid conflicting actions. While FDA and FSIS worked together to make decisions on the preferred course of action, each agency was responsible for communicating its decisions to producers or processors under its jurisdiction. We believe the report describes the Food and Drug Administration’s actions and adequately captures the agency’s reasons for choosing to halt the distribution of food products with dioxin levels above one part per trillion. However, as we have stated, the Food Safety and Inspection Service’s guidance to the affected producers and processors was impractical because it did not provide enough time for some processors to test and receive results before the agency’s deadline and because it was not delivered to the producers in a timely manner so that they were aware of the steps that needed to be taken before they could deliver their products to market. 2. 3.
Why GAO Did This Study

Pursuant to a congressional request, GAO reviewed the performance of federal agencies in handling their investigation into elevated dioxin levels in poultry samples, focusing on: (1) the basis for the agencies' decisions to require producers to demonstrate their food products did not contain levels of dioxin above one part per trillion; (2) their effectiveness in working together to make decisions to address the problem of dioxin; and (3) the impact of the food safety system on the handling of this dioxin incident.

What GAO Found

GAO noted that: (1) the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) requested the producers and processors to halt the distribution of food products with dioxin levels above one part per trillion because of their concern about the potential risk to human health that these products might present; (2) while scientists have not yet determined the level of dioxin that poses a danger to human health, FDA and FSIS believed that one part per trillion was an appropriate level to use for halting the distribution of these products; (3) FDA chose the one-part-per-trillion level to distinguish food products with elevated dioxin levels from those products with background dioxin levels; (4) the federal agencies worked cooperatively to identify the source of the dioxin contamination and to decide on the actions that might be necessary to address any health risks the contaminated food products posed to consumers; (5) however, their guidance to the affected producers and processors was sometimes unclear and impractical, which left the affected producers confused about the actions they needed to take; (6) for example, FDA, which is responsible for fish products, told producers they had to test their products, but the agency did not tell them how to collect their samples for testing; (7) in addition, the producers expressed concern that the agencies did not provide them with adequate time to comply with the agencies' testing requirements; (8) in some instances, the testing process took longer than the time allowed under the deadline; (9) although these regulatory actions delayed some food products from reaching the market, industry officials told GAO that FDA's and FSIS's actions did not result in the widespread destruction of affected food products; (10) in addressing the dioxin incident, the agencies involved had to overcome the inherent inefficiencies associated with the current food safety system, which divides responsibility for ensuring food safety among several agencies; and (11) as GAO has reported on numerous occasions, this fragmented food safety system necessitates extensive coordination efforts to minimize wasteful duplication of effort, prevent gaps in regulatory coverage, and avoid conflicting actions.