F.D.A.'s global food safety strategy

by Jay Sjerven
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The Food and Drug Administration on June 20 unveiled a strategy it said would meet the challenges posed by rapidly rising imports of F.D.A.-regulated products including food. The strategy mandates all parties along the import product supply chain be held accountable for product safety and quality and called for the establishment of regulatory coalitions that join the F.D.A. with an expanding number of counterpart agencies from other countries.

In introducing the new strategy, “Pathway to Global Product Safety and Quality,” Margaret A. Hamburg, F.D.A. commissioner, said, “F.D.A.-regulated imports have quadrupled since 2000. The F.D.A. and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face. The F.D.A. must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources.”

The F.D.A. strategy document indicated U.S. food imports have grown nearly 10% each year for the last seven years. The F.D.A. said between 10% and 15% of the U.S. food supply is imported, including two-thirds of the fruits and vegetables and 80% of the seafood consumed in the United States.

U.S. imports of foods and food ingredients were expected to continue to rise at a rapid pace, yet the F.D.A. has been able to inspect at port only a minute portion of the foodstuffs imported into the United States, and the agency’s inspections of overseas food manufacturing facilities have been limited by the paucity of resources dedicated to that purpose.

The F.D.A. received both increased responsibilities and

autahorities with regard to ensuring the safety of food imports under the Food Safety Modernization Act (F.S.M.A.), which was signed into law in January. It seemed unlikely Congress will provide anywhere near the resources required for the agency to fully meet the new mandates under the F.S.M.A., hence the urgency with which the F.D.A. strategy addressed the issue of coalitions of regulatory agencies of trading partners.

Among other things, the F.S.M.A. requires the F.D.A. inspect 600 foreign food facilities this year with the number of inspections to be doubled every year for the next five.

“While the goal may be attainable in the first year, it would be impossible for F.D.A. to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates,” the agency said.

The F.D.A. said in order to meet its responsibilities it is committed to substantially revising its approach to global product safety and quality.

“Over the next decade, F.D.A. will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders,” the agency said.

The F.D.A. said it is developing an international operating model for regulatory coalitions that relies on enhanced intelligence, information sharing, data-driven risk analytics and the “smart” allocation of resources through partnerships. It provided four building blocks that would underpin the new coalition-based strategy.

First, the F.D.A., in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world. Second, with the coalitions, the F.D.A. intends to develop a global

data information system and network in which regulators worldwide may regularly share real-time information and resources across markets. Third, the F.D.A. will continue to expand its capabilities in intelligence gathering and use with increased attention on risk analytics and thoroughly modernized IT capabilities. And fourth, the F.D.A. will allocate agency resources based on risk, leveraging the combined efforts of government, industry and public and private sector third parties.

David Acheson, managing director, food and import safety practice, Leavitt Partners, Washington, said the publication of the F.D.A.’s import strategy “sends a strong signal to importers in the United States and exporters in other countries shipping food to the United States that the F.D.A. is placing a high priority on the safety of imported food and the new responsibility that the private sector is expected take on to ensure food safety.”

Mr. Acheson said the strategy affirms the F.D.A.’s goal to transform itself into a global agency where product safety and quality are paramount and borderless.

“The agency recognized rightly that they will need to rely heavily on partnerships and coalitions to expand their global reach in order to make this a successful transformation,” he said.

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