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Import Safety Working Group Publishes Dubious Framework Pundit Text:

Jim Prevor’s Perishable Pundit, September 11, 2007

The President appointed a high level Interagency Working Group on Import Safety via an Executive Order on July 18. Although it established the issue as high priority, one would also be tempted to think it is a bit phony as one suspects — maybe even hopes — that the Secretary of State, Secretary of Homeland Security, and the Secretary of the Treasury have other things to deal with than pesticide on ginger or lead paint on toys.

In mid-November, the Working Group is expected to issue its final report, but in the meantime they have published a “strategic framework,” which you can read here.

The FDA is pleased:

STATEMENT BY COMMISSIONER von ESCHENBACH
ON THE RELEASE OF THE STRATEGIC FRAMEWORK DOCUMENT
ON IMPORT SAFETY

Background: HHS Secretary Leavitt today delivered to President Bush a strategic framework on import safety. The framework was developed by the Interagency Working Group on Import Safety, established by the President July 18 to examine our nation’s system for assuring that all of our imported products are safe. For more information, visit: http://www.importsafety.gov.

“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.

Recent recalls of imported products have caused Americans to question the safety of imports. Americans rightly expect to purchase food and medical products without having to worry about their safety; and assuring the safety of these products is a core part of our mission at the FDA. The President has charged the Interagency Working Group to focus their efforts on how to work smarter and better with importers, manufacturers, and other governments to better assure that the imported products we purchase are indeed safe. As part of this Presidential initiative, Secretary Leavitt and I have traveled extensively these past few months throughout the U.S. visiting the Agency’s field operations. Across the country, we witnessed our field staff standing shoulder to shoulder with our partners from the U.S. Department of Agriculture and Customs and Border Protection and others, working together to assure the safety of imported products. In visits to nearly 20 cities/ports from Oakland to Miami, including El Paso, Tex.; Newark, N.J.; and Memphis, Tenn, we saw dedicated professionals doing difficult work; observing first hand the diligent efforts of FDA employees and what they do every day to protect the American people. Most importantly, we heard from these professionals many ideas on how they believe we could do this job better and smarter.

The three organizing principles that form the keystones of the Strategic Framework: Prevention, Intervention and Response are ones we embrace strongly here at FDA and are principles we know will guide us towards better and smarter import safety strategies. We know that in the 21st century’s global economy, 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. I am excited about the fact that these principles have been embraced by the Framework, and I look forward to working with the Group on the Action Plan to be released in November. Together, we will further integrate and enhance our processes relating to the safety of imports.”

Yet the three “organizing principles” strike us as predictable:

Three organizing principles are the keystones of the Strategic Framework:

1. Prevention — Prevent harm in the first place.

The U.S. government must work with the private sector to adopt an approach to import safety that builds safety into manufacturing and distribution processes. Producers and the importing community will play a key role in accomplishing this objective by implementing preventive approaches and requiring these approaches from their suppliers. In addition, third-party certifications and testing requirements can play an important role in this area, as can credible manufacturer supply-chain management programs. Continued enforcement activities will also create incentives by deterring bad actors and encouraging U.S. importers to review their suppliers. The federal government will be prepared to work with the importing community to further develop the tools and science necessary to better identify those imports that pose the greatest risk, and to identify the points in the import life cycle where the most effective intervention can take place to ensure the safety of these products. The federal government will also be prepared to work with foreign governments to oversee manufacturers within their borders to help ensure safe domestic production practices that facilitate safe imports meeting U.S. safety standards and other requirements, such as the enforcement of intellectual property rights.

2. Intervention — Intervene when risks are identified.

Federal, state, local, and foreign governments, along with manufacturers and the importing community, must adopt more effective techniques for identifying potential product hazards. Through risk-based inspections and sampling utilizing science-based detection technology, government officials can more effectively detect potential import hazards. When problems are discovered, government officials must act swiftly and in a coordinated manner to seize, destroy, or otherwise prevent dangerous goods from advancing beyond the point-of-entry. The earlier potential hazards are identified, the greater the likelihood of successful interventions. The private sector’s meeting requisite pre-entry documentation and certification requirements also plays a pivotal role in helping to identify potential product hazards.

3. Response — Respond rapidly after harm has occurred

In the event that an unsafe import does make its way into the domestic stream of commerce, swift actions must be taken to limit potential exposure and harm to American consumers. In most instances, existing product recall mechanisms have proven capable in this regard. But we can do more.

We need a more robust, collaborative system of response that leverages information already available to the importing community for the benefit and protection of the consumer. While the response would be led by the federal government, in close collaboration with state and local governments, it would involve the manufacturer, importers, and retailers in order to contain the problem rapidly, recall any products of concern, and inform customers and the general public.

There are many interesting and true things in the report and, of course, we have to wait to see what the final report says.

Yet we confess to a certain skepticism. The report is filled with paragraphs such as this:

We must develop a culture of collaboration that will permeate the relationships among federal agencies as well as our relationships with external partners. All parties (federal, state, and local governments, foreign governments, foreign producers, and the importing community) involved in the import life cycle need to work together to prevent unsafe products from entering the U.S., and to take swift and effective action if such products do enter domestic commerce.

Yet admonitions — “we must” — do not create realities and in our quick read of the report, we see no evidence that anything is going to change very much.

Government officials have been traipsing around America learning about this subject. We highlighted one visit to a produce port facility here.

The whole thing is so self-consciously political. To start with, the panel was ordered to come up with a plan that didn’t cost a dime. So you see what a low priority this is. The prominent press at each visit by a cabinet secretary to some facility made it clear the goal was less education than projecting an image of “working to resolve the problem.”

Now this initial plan — written in consultant-speak (the six building blocks, the three organizing principles, etc.) — makes clear than any change will be an enormous amount of effort to achieve tiny incremental change.

You can learn about the public meeting here.

You can submit comments to the Working Group on Import Safety here. And you can watch a video with Department of Health and Human Services Secretary Michael Leavitt, who chairs the Working Group, right here.

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