A Medical Device Daily

Michael Leavitt, secretary of Health and Human Services, presented to the White House on Monday a strategic framework for the safety of imported products, a project mandated via a July 18 decree by President George W. Bush.

Leavitt’s cover letter for the final report by the Interagency Working Group (IWG) on Import Safety says that the U.S. imports about $2 trillion worth of products annually “and experts project that this amount will triple by 2015.” Leavitt also said that Uncle Sam “cannot and should not attempt to physically inspect every product” entering the U.S., and while “it is not possible to eliminate all risk with imported and domestic products, being smarter requires us to find new ways to protect American consumers and continually improve the safety of our imports.”

Leavitt said that the IWG recommends “working with the importing community to develop approaches that consider risks over the life cycle of an imported product, and that focus actions and resources to minimize the likelihood of unsafe products reaching U.S. consumers.”

FDA commissioner Andrew von Eschenbach said in a statement posted yesterday on the FDA web site that “I strongly endorse the release of the Strategic Framework developed by the Interagency Working Group on Import Safety and commend Secretary Leavitt for leading this comprehensive effort.”

Von Eschenbach said that recent problems with imported products have stimulated concern among American citizens and that the IWG is charged with finding ways to help government agencies “to work smarter and better with importers, manufacturers, and other governments to better assure that the imported products we purchase are indeed safe.” The FDA chief also noted that he and Leavitt “have traveled extensively” to get a feel for what the employees of the federal government are up against in screening out unsafe products. “Most importantly, we heard from these professionals many ideas on how they believe we could do this job better and smarter,” von Eschenbach said.

The FDA statement said the three organizing principles behind the Strategic Framework are prevention, intervention and response and that “our efforts to assure product safety for Americans cannot just begin at our borders, they must begin at the time the products are produced in other countries.” Von Eschenbach said that FDA and other agencies “will further integrate and enhance our processes relating to the safety of imports.”

Dick Durbin (D-Illinois), the Senate majority whip, blasted the plan as “too tentative when it comes to real reform” and said that he was “disappointed that they have not faced the resource requirements head on.”

The report notes that the federal government’s efforts will focus on three areas. One is improved collaboration, with the report noting that “the agencies should expand on existing public-private relationships, such as COAC (Commercial Operations Advisory Committee), TSN (Trade Support Network), F&ASCC (Food and Agriculture Sector Coordinating Council), ITACs and ATACs (Industrial Trade and Agricultural Trade Advisory Committees), and other groups, to seek and share the importing community’s recommendations and best practices with the objective of enhancing import safety and promoting comprehensive supply chain verification.”

The second point of emphasis will be on acceleration of interoperability. According to the report, the Security and Accountability for Every (SAFE) Port Act of 2006 “requires all federal agencies that license, permit, or certify imported products to participate in the International Trade Data System (ITDS),” described as a “single-window” system for electronic reporting on imports and exports.

At present, 34 federal agencies are said to be participating in the effort and are “at varying stages in integrating” into the system. The report also urges the Office of Management and Budget to “issue a directive to participating government agencies requiring that within 60 days of the directive, they establish or refine their implementation plan setting deadlines for developing, reviewing and finalizing conceptual operating plans (Concept of Operations), memoranda of understanding for the ITDS interface, and a set of technical and business requirements for identifying any program and system modifications needed to support the interface.” Each agency is also called on to pinpoint the necessary financial resources in their 2009 budget submissions.

Other points of emphasis include global collaboration, which for now would essentially entail an exchange of ideas about imported food safety, and the last step, agreements with other governments, would involve bilateral and multilateral agreements with other nations to coordinate activities and to reduce redundant safety efforts.

The conclusion of the report states that the benefits of international trade “are wide-ranging, yet ... bring with them new and complex challenges” that will require shifting from the current model that relies on ‘snapshots’ at the border to interdict unsafe products to a cost-effective, prevention-focused “video” model that identifies and targets those steps in the import life cycle where the risks of unsafe products is greatest and verifies the safety of products at those important phases.”

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