Irene Chan has a very challenging job—helping ensure that billions of dollars in food products imported every year into the United States from China meet American safety standards.

As the assistant country director for the Food and Drug Administration’s (FDA) China office in Beijing, Chan’s primary role is to work with Chinese regulatory authorities, educate food companies about U.S. requirements and encourage more stringent food safety practices.

“We are establishing relationships with our regulatory counterparts and reaching out to industry,” said Chan. “We want to work in a cooperative way, not just say there are problems. We are here to try and help them lift their standards.”

The FDA opened the first of its three China offices in Beijing in late 2008, and then in the cities of Shanghai and Guangzhou, to provide greater oversight, additional inspections and collaboration regarding food, pharmaceuticals medical devices and cosmetics that are exported to the United States. China is the fourth largest exporter of food to the U.S.

Daniel Hsu

The U.S. presence in China came after a series of pharmaceutical and food safety scares, including concerns about illegal antibiotics in farm-raised seafood and tainted pet food. In 2008, the FDA restricted the entry of all food products from China containing milk after inspectors found evidence of the industrial chemical melamine.

Chan said the food industry is so large and the ability of the FDA to conduct inspections of exporters is so limited that her office takes a risk-based approach, focusing on high volume companies and products that require close scrutiny. This recently has included seafood exporters and processors of low acid canned foods, including mushrooms, bamboo shoots, vegetables and certain fruits.

“The state of the industry is extremely varied,” said Chan. “There are some companies with state-of-the art equipment that are top of the line, and there are really low-level mom and pop shops producing food.”

From the FDA viewpoint, Chan said, it is challenging gathering information in such a large country. “A lot of people are doing food manufacturing and process that we are not even aware of,” she said.

In addition, Chan said that she and her colleagues face language and cultural barriers, and challenges getting data and being told the “true story.” She said many food processors have had little contact with the FDA and have concerns, but “they need to abide by our rules if they want to export to the United States.”

Chan said China has been seeking to improve its regulatory oversight, and is well aware that “a few bad actors can ruin an industry and the China brand.” China approved a new food safety law in 2009 with tougher punishments, while President Obama signed a new food safety law earlier this year that imposes stricter scrutiny of imports.

Christopher Hickey, the director of the FDA’s China office, said Chan has a “deep understanding of the broader cultural, economic and political context in which FDA operates in China.”

“Her work requires significant skill and diplomacy, and management of multiple constituencies,” said Hickey. “Her keen intellect, professional skills and experience make her well-equipped to recognize local political, regulatory and industry trends, and to make strategic recommendations for areas where FDA should direct its resources in China.”

Hickey said Chan has helped streamline and strengthen the process by which U.S. inspections of Chinese food facilities occur, and has been instrumental in working with central Chinese authorities to help them understand the importance of FDA inspections.

Chan said that when she first arrived in China about two years ago, there was “a lot of fear about what the FDA was doing.” While her job is to protect public health and block unsafe foods from being imported into the United States, Chan said the emphasis of the FDA office is to help Chinese companies meet safe manufacturing standards.

“We are not here to block trade. Our job is to facilitate trade by ensuring that companies come into compliance with our food safety rules.”

This article was jointly prepared by the Partnership for Public Service, a group seeking to enhance the performance of the federal government, and Go to to read about other federal workers who are making a difference.