Import and Export Lessons from Germany's E. coli Outbreak

Commenting on the recent E. coli outbreak in Germany, Benjamin England, former FDA Regulatory Counsel and CEO of FDAImports.com, said, "any grower or packer of fresh fruits and vegetables shipping to the U.S. with the misfortune of experiencing a similar contamination should expect to receive at least as harsh a response from the U.S. Food and Drug Administration as Spanish cucumber suppliers are experiencing in Germany, Sweden, Denmark, Britain and other European countries, and in Russia," said

E. coli is ordinarily introduced into the food supply chain in one of two major ways, he said, either at the produce source due to inadequate controls at the farm or by cross contamination from humans due to a lack of adequate controls in a packing facility.

"We do not yet have enough information in the current E. coli cucumber scenario to determine the source of this contamination," England said, adding, that fact alone illustrates the importance of one of the primary steps a company implicated in a food borne outbreak should undertake: isolate and identify the source of the contamination. If the implicated company cannot isolate the source, it will be very difficult to demonstrate that the food safety breach has been or can be contained. In addition, it is difficult to minimize the scope of food safety recalls if the implicated company cannot show why one or two lots are contaminated but four or ten other lots are not.

Importers and exporters should take note, he added, that, on the one hand, safety controls for imported food products tend to be evaluated with less frequency and therefore, more products are imported with less oversight by agencies such as the FDA and the various food inspection agencies in EU countries. On the other hand if an outbreak occurs, the frequency of imported food inspections and regulatory evaluation increases from “less frequent” to “almost every shipment.” Rarely can a food supply chain tolerate such a high level of inspection scrutiny. In the United States, FDA often issues an Import Alert for implicated produce, which acts as a virtual ban of implicated produce from the country identified as the contamination source – irrespective of whether only one or a few suppliers are actually identified in the product trace backs.

England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs.  Currently he is founder and CEO of FDAImports.com, LLC.