By Ariana Eunjung Cha and Annys Shin
Washington Post Staff Writers
Wednesday, December 12, 2007
BEIJING, Dec. 12 -- Chinese officials on Tuesday agreed to implement a detailed experimental tracking and data-sharing program for a limited number of foods, drugs, and medical devices bound for the United States. U.S. officials hailed the agreement as a breakthrough, but independent food safety experts said they are skeptical about China's ability to impose such a system on its diffuse farm and chemical industries.
Under the two agreements signed Tuesday, the United States will be able to track certain food and drug exports from China as part of a broader registration and certification process designed to allay worries about the quality of Chinese products.
When crises over specific products erupt, as they did this year over pet food and seafood, Chinese officials have promised to allow U.S. officials access to Chinese food-processing plants and factories quickly. In the event a product is discovered to have an "imminent or significant danger to health," China must notify the United States within 48 hours.
The agreements are key components of the food import safety plan that President Bush announced last month. They are also part of a larger overhaul of how the Food and Drug Administration handles imports.
The key breakthrough was "broader access by U.S. officials to producers in this country," Health and Human Services Secretary Mike Leavitt said Tuesday while touring a juice factory outside Beijing.
Leavitt and other U.S. officials were in Beijing for trade talks. In his opening remarks at the third session of the strategic economic dialogue Wednesday, U.S. Treasury Secretary Henry M. Paulson Jr. said both countries must "resist attempts to reduce transparency or increase regulatory obstacles in order to protect domestic industries."
"Neither China nor the United States can protect our way to further prosperity," Paulson said.
Chinese Vice Premier Wu Yi's remarks were more pointed. She spoke about the 50 or so China-related bills pending in Congress. Calling them "protectionist," she said both sides must "oppose attempts to politicize trade issues."
"I need to be quite candid about this: If these bills are adopted, they will severely undermine U.S. business ties with China," Wu said.
The nearly two dozen types of goods affected by the two agreements reached Tuesday include many of concern to U.S. consumers, such as pet food and farm-raised fish. Drugs and medical devices affected include pacemakers, insulin, human growth hormone, condoms and antibiotics.
The products covered by the agreements represent a tiny fraction of the estimated $341 billion worth of goods China is expected to sell to the United States this year. Senior HHS officials said more products can be added later by mutual agreement, but the United States first needs to gain confidence in China's oversight capabilities.
China's State Food and Drug Administration, for example, has been focused on policing China's domestic drug market and has less experience overseeing exports, HHS officials said. As a result, U.S. regulators will work with the agency to build a system to certify drugs and medical devices. A different agency, the General Administration of Quality Supervision, Inspection and Quarantine will certify food for export.
The agreements, hammered out during four rounds of talks between July and November, charge Chinese officials with creating a system to register all exporters to the United States and to inspect them annually. The Chinese are to provide U.S. regulators with a list of registered exporters and any that have fallen out of compliance with Chinese rules.
China is also supposed to create a secure electronic system to track shipments so problems can be traced to their point of origin.
The programs would be subject to audits by U.S. authorities.
"We want to make things easier for people who keep the rules and harder for those that don't," Leavitt said.
Regulators from both countries are to meet over the next three months to develop a plan for implementing the agreements.
Beyond the agreements, FDA Commissioner Andrew C. von Eschenbach said in Beijing that the agency hopes China would be the first of five countries where the FDA hopes to open overseas outposts in the near future. "This would be an opportunity to have people here on a continuous basis with expertise so we can work with our Chinese colleagues," he said.
Leavitt stressed that while he had talked to all the ministries that might be involved in helping host FDA inspectors in China, the details had not been worked out. He said he could only say he is "optimistic it would occur."
Food safety experts hailed the deal with China while questioning whether it could be fully implemented.
Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest and a frequent critic of the food import safety system, called the agreements "a good model for how to manage imports in a global food market." But she said the FDA does not have the resources to fulfill its side of the agreements.
HHS officials didn't say how much the deal would cost. Leavitt has acknowledged that the FDA needed more funding and that the president's budget proposal, expected to be released in late January, would include specific amounts.
Chinese officials face even tougher challenges, several analysts said.
Differences in local standards and the millions of people involved in the process "are going to make consistent interpretations of the regulations extremely difficult," said David Closs, a global food supply expert at Michigan State University.
Food production "is a vast cottage industry" that the Beijing government has "very little influence on," said William Hubbard, a retired associate FDA commissioner. "The critical question is whether this kind of [agreement] can work in a widespread, fragmented industry."
Iowa State University economist Helen Jensen said the exception may be large producers in certain markets that China dominates, such as apple juice concentrate. Supported by foreign investment, they often employ state-of-the art technology and are probably able to force their suppliers to meet U.S. requirements.
In China, the agreements were seen as a major concession by the government, which for months refused to acknowledge that any problem existed.
Jin Canrong, vice dean of international studies at Renmin University in Beijing, said the agreement represents "a very big response to U.S. demands."
For China, which has in the past declined to reveal information that might be considered letting outsiders to meddle in its internal affairs, "sharing data is a big offer to the United States."
Shin reported from Washington. Researcher Crissie Ding contributed to this report.