September 11th and Risk

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  • 09/11/2007
From today's edition of the Wall Street Journal ...

Risk-Based System Urged for Import Safety
September 11, 2007

WASHINGTON -- A White House panel studying ways to improve import safety said the U.S. should shift to a preventive system focused on risky products, conceding that the U.S. can never inspect enough foreign goods to protect consumers from every potentially harmful item.

Under such a system, the government would collect data from private and public sources, identify safety hazards along the entire "life cycle" of the imported products and manage the risk earlier in the import process. A database for such use is already being developed and officials say its implementation could be pushed to 2009 from 2011.

"It's a change from an intervention-focused strategy to a risk-based approach focused on prevention with verification," said Health and Human Services Secretary Mike Leavitt, who heads the panel of senior officials from 12 federal agencies. "Instead of a point-in-time assessment at the border, we're recommending a focus on the full import life cycle, building safety into the products that we purchase every step of the way."

The risk-based concept isn't new. Major elements of the recommendation mirror a 2002 Food and Drug Administration proposal aimed at improving import safety, but was shelved because of, among other reasons, a lack of funding. Earlier this year, FDA officials dusted off the plan after a spate of food scares put them under fire on Capitol Hill.

The panel's recommendation, if adopted, would apply to all agencies that regulate imports, such as the Consumer Product Safety Commission. Mr. Leavitt declined to say how much the system would cost, or what specific actions are needed. The panel is scheduled to release action plans in November.

The Bush administration has been grappling with import-safety issues in the wake of a string of recalls and problem products, including toys, tires, seafood and tainted pet-food ingredients, almost all from China. (See related article.)

The turn of events pleased some food-safety experts. "It's a good thing they've gone back to the FDA's early thinking," said William Hubbard, a former FDA associate commissioner. "The question is whether sufficient funding can make it happen."

But Benjamin England, a co-author of the 2002 FDA plan who now runs a consulting firm,, said Mr. Leavitt's recommendation falls short of addressing solutions to the current import mess.

"In an effort to elevate from an intra-agency risk-based program to an inter-agency risk-based program, a lot was lost in translation," he said. For example, the report didn't define risk, didn't place more responsibility onto foreign manufacturers and the proposed data system is intended more for collecting trade data than assessing risks with products.

U.S. officials are also holding private discussions with Chinese regulators, both in the U.S. and in China, to enhance the safety of products such as food and drugs.

In Beijing, China's top quality-inspection official challenged U.S. regulators to play a more active role in screening Chinese exports for tainted goods, proposing that the FDA ban products from companies that haven't passed muster with Beijing in order to weed out the most flagrant violators. An FDA spokesman said the agency looked forward to working with the Chinese, but declined to elaborate.

Yesterday, U.S. and Chinese regulators agreed on a plan to eliminate lead in toys from Chinese companies and to enhance scrutiny of the toy-making process, people familiar with the talks said. Details will be announced today at the Second Biennial Sino-U.S. Consumer Product Safety Summit here.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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