Hoping to get a better handle on the safety of food, drug and medical-device imports, the U.S. government is setting up its first offices in China staffed with American inspectors, and a senior U.S. official suggests stepped-up efforts could follow in areas like toys and other consumer products.
The Food and Drug Administration said Nov. 18 it is putting offices in Beijing, Shanghai and Guangzhou — its first outside the United States — to work more closely with Chinese government officials and exporters on food and medical safety issues.
``The strategy of simply standing at the border and catching things as they come in is not going to work,'' Secretary of Health and Human Services Mike Leavitt said at a Nov. 19 ceremony in Guangzhou. ``We need a basic strategic change.''
FDA offices in China will be followed this month by offices in India, and next year by offices in Europe, Latin America and the Middle East. Leavitt said the change is a reaction to big increases in the amount of global trade and is not specific to China.
Leavitt, who headed a U.S. initiative among 14 separate agencies to look at how to improve monitoring of product safety in an increasingly global economy, said at a Guangzhou news conference that the plan by American officials to get closer to global supply chains will not be limited to the FDA.
``This is a governmentwide strategy,'' Leavitt said. ``You'll see the Consumer Product Safety Commission, the Department of Agriculture and other relevant agencies acting in harmony with this strategy,'' he added, without giving details.
Specifically, FDA's plan involves several facets, including putting eight U.S. government inspectors on the ground in the three cities, and working more closely with Chinese government officials and Chinese companies.
The U.S. government wants to build stronger regulatory links with Chinese officials and develop third-party certification programs for imports to the U.S., said FDA Commissioner Andrew von Eschenbach.
``These offices in China are not just about inspections,'' von Eschenbach said. ``They are about the opportunity to work collaboratively with Chinese regulators and build capacity.''
He added that the additional presence in China should help U.S. officials target problems.
``We will have the ability to intervene more effectively ... where we see critical points in the production and supply chain of these products, where problems might occur,'' von Eschenbach said.
China exports about US$320 billion of products to the United States annually, accounting for about one-sixth of America's $2 trillion in imports. Chinese exports have risen fivefold in the past decade.
Some Chinese firms at the Guangzhou event raised concerns about their products being held up at U.S. ports, and Leavitt said U.S. officials had put holds on some products recently over safety concerns.
The U.S., for example, recently halted imports of Chinese dairy products until the products could be proven free of melamine, an industrial chemical improperly added to milk products in China that has killed at least three babies there and sickened thousands.
U.S. officials said details such as how the third-party certifications would work were still being hammered out, but Leavitt invited industry and government officials from China and other countries to contribute.
He said companies should work together as industries to develop ``scientifically rigorous'' standards that U.S. government officials could agree to, and that could then be used by third-party inspectors to speed imports without compromising safety. He admitted that process could take years.
A Chinese court last year sentenced to death the head of its version of the FDA for taking bribes to approve shoddy drugs that reportedly killed several people.
Leavitt said U.S. officials have confidence in the Chinese regulatory system, and said problems are a small percentage of overall trade. ``I think it is clear from actions in China that they take this very seriously,'' he said.
