Plan suggests vital role for food industry in redesigning import inspection system

by Jay Sjerven
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WASHINGTON — Mounting concerns about the risks associated with food imports have helped revive ideas aimed at conducting inspections more thoughtfully than in the past. The plan was first presented in a report presented to the leadership of the Food and Drug Administration in 2003, according to two of the plan’s principal authors, Benjamin L. England and Carl R. Nielsen. The plan submitted to senior F.D.A. officials proposed replacement of the current "invoice-based" inspection process with a risk-based system requiring unprecedented cooperation and sharing of information by the F.D.A., other government agencies and the U.S. food industry and its suppliers abroad. The proposal itself was shelved as the woefully under-funded F.D.A. grappled with competing priorities. But food safety events involving imported foods and food ingredients forced issues addressed by the plan back to the fore.

Dr. David Acheson, F.D.A.’s assistant commissioner for food safety, was charged at his appointment on May 1 with developing an enhanced risk-based inspection system for both domestically produced and imported food. Dr. Acheson told Food Business News that assuming approval by the Department of Health and Human Services, the F.D.A. may roll out a plan in the next few months. He said the Import Strategic Plan tabled for consideration four years ago reflected thinking of that time. He said given the goal of creating the best possible system, certain elements of the earlier plan could be utilized. He emphasized he wasn’t endorsing the 2003 plan.

"But certain products of good thinking then could be brought forward," he said. "Why reinvent the wheel?"

When they presented their plan to the F.D.A. management team, Mr. England was regulatory counsel to the associate commissioner of regulatory affairs, and Mr. Nielsen was director of the division of import operations and policy of the F.D.A.’s Office of Regulatory Affairs. Both Mr. England and Mr. Nielsen retired from the F.D.A. and are co-founders of, a consulting company.

Mr. Nielsen said the current import inspection system is "invoice based." The invoice provides certain information such as the identity of the seller, emergency contact and a description of the product, but often not much more than that, Mr. Nielsen said. Under the circumstances, it is difficult for the roughly 220 full-time import food inspectors to decide which and how many of the up to 17 million import product shipments to sample and inspect, he said.

The F.D.A. currently inspects less than 1% of food imports, and even in the immediate aftermath of September 11 struggled to reach a 2% rate of inspection, Mr. Nielsen said. But both Mr. England and Mr. Nielsen asserted the goal wasn’t to simply increase funding with the goal of reaching an inspection rate of 5% or even 10%.

"How does inspecting 10% of imports on a random basis assure the consumer the remaining 90% is more safe," Mr. England said. What was required was an entirely new approach, focusing attention on high-risk products and/or suppliers.

"In order to determine which imports are high in risk, the F.D.A. must be able to determine which products are low in risk," Mr. Nielsen said. This requires information on the products themselves, how they were manufactured, packaged and transported, and on manufacturing companies and shippers. The F.D.A. lacks such extensive information currently, but much of the information required to make inspection assessments based on risk exists in other government agencies and in purchasing departments of U.S. food manufacturers. It is a matter of compiling the information into an F.D.A. database accessible to its inspectors so they are able to make quick, risk-based decisions.

Mr. Nielsen gave the example of imported bottled water. He asked why the F.D.A. should waste time inspecting bottled water from a particular foreign manufacturer if that same manufacturer provides bottled water to the U.S. Armed Forces and its facilities were inspected by the Department of Defense.

Similarly, many U.S. food manufacturers directly inspect or have credible third parties inspect the manufacturing facilities of their suppliers. Food companies after all have a huge stake in the safety of the foods and ingredients they import.

Dr. Acheson said he envisions a critical role for industry in an enhanced risk-based import food inspection system.

"It’s already industry’s obligation to produce safe food products," he said. "And we’re well aware that most companies react swiftly when something goes wrong. Industry often is in the best position to put into place preventive strategies. F.D.A. and industry must have dialogue to determine what those strategies should look like and determine where are the greatest risks.

"My message to industry is we look at this as a cooperative effort. There must be dialogue between the F.D.A. and industry. I don’t see F.D.A. coming up with all the answers."

Even with a major increase in funding, the F.D.A. itself will never be able to more than scratch the surface with regard to inspecting the 200,000-plus foreign food manufacturing plants that supply products to the U.S. But compiling the data already in the hands of other government agencies, food companies, foreign governments and third-party inspectors would fill many gaps in knowledge and allow F.D.A. inspectors to concentrate their attention on more high-risk products and origins.

Mr. England and Mr. Nielsen acknowledged that a degree of randomness in inspections was required to keep the system "honest," but a system based on inspections conducted mostly on a random basis will never provide the safety assurance required.

Mr. England and Mr. Nielsen agreed the F.D.A. would have to reach out to the food industry for a risk-based system to work. But they said the food industry would find incentive to participate in the system in the form of winning "low-risk" status for products in their pipelines, as while few import shipments are actually inspected, screening products for possible inspection often may lead to delays, which are pointless in the case of products that demonstrably pose low risk. A risk-based system could actually facilitate the import of such products, they said.

This article can also be found in the digital edition of Food Business News, June 26, 2007, starting on Page 1. Click here to search that archive.

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