FDA looks abroad to increase food safety
By ARIEL OLSON SUROWIDJOJO
Observer Staff
April 2, 2008
Poisoned toothpaste, toxic fish and contaminated pet food are just some of the products that raised food safety concerns in the United States last year. All of the items, or certain ingredients, were imported from China—a nation that has commanded the attention of food regulatory commissions worldwide, as it struggles to sufficiently monitor its rapidly growing exports. In March, the U.S. Food and Drug Administration announced plans to establish several permanent offices in the People’s Republic by 2009, pending China’s authorization.
FDA press officer Stephanie Kwisnek said the foreign posts are just one step in the process of addressing concerns for the safety of U.S. imported foods. She also indicated that the agency plans to increase its overall presence abroad by “build[ing] capacity at foreign sites in at least five regions, beginning with China.”
AU PERSPECTIVES: Students voice a variety of opinions about food safety.
Video by Federica Narancio and Ariel Olson Surowidjojo.
“The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that FDA-regulated products—food, drugs, medical devices and cosmetics—that are shipped to the United States meet U.S. standards for safety [and] manufacturing quality,” Kwisnek said by e-mail.
In recent years, cheap labor and lax environmental and safety regulations have attracted scores of foreign manufacturers to China’s shores. While machinery, office equipment and textiles remain among the nation’s top exports, the exportation of food and food ingredients, particularly to the United States, has increased dramatically.
Last year alone the United States imported more than $4.9 billion of fish and agricultural products from China. According to U.S. Census trade data, that is more than twice the amount of food imported from the country just four years earlier.
But as the demand for food imports continues to rise; the FDA’s capacity to inspect these deliveries has been drastically reduced. According to the census, combined food and forestry imports have increased by 39 percent since 2003. Although the agency’s inspectors still review 100 percent of all entry documentation, they physically inspect less than 1 percent of all imported products, according to the FDA.
William Hubbard, a spokesman for the Coalition for a Stronger FDA and a former senior associate commissioner for policy for the agency, said the FDA simply doesn’t have enough staff to keep up with the deluge of imports.
“The growth in imported food in the United States has skyrocketed,” Hubbard said in an interview last fall. “Our paradigm needs to shift from putting all the responsibility on the FDA, at the border, to inspect when food arrives here, to putting more responsibility on the exporters in China, or wherever, to inspect the food before it’s ever put on the boat.”

REUTERS Photo
Workers cut Matsutake mushrooms in a Matsutake factory in Shangri-La in China’s southern province of Yunnan August 25, 2006.
On March 14 of this year the FDA announced a plan to accomplish that goal. The proposal, which has yet to be approved by Chinese authorities, would establish eight permanent, full-time FDA positions at U.S. diplomatic posts throughout China, including the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou. As part of the FDA’s “Beyond Borders” initiative, the plan aims to enhance the agency’s ability to communicate directly with Chinese manufacturers and to increase inspection of their facilities.
“In an age when a border is not a barrier, the globalized economy demands nothing less that heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters,” said the FDA’s Murray Lumpkin, deputy commissioner for International and Special Programs, in a press release. “Our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market.”
The FDA said it plans to fill the positions, and hire five additional Chinese nationals to work with U.S. employees, over the next 18 months. But according to Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America, the new plan won’t necessarily lead directly to an increase in food safety. Waldrop said the FDA also needs to take further action to establish food safety standards, to increase regulation of Chinese exports and to verify that imported foods are safe for consumers.
“Just putting people on the ground in China isn’t going to solve the problem,” Waldrop said. “You need to have the full buy-in of the Chinese government and their inspection system regulating that the food will be safe.”
Although Chinese authorities have not officially approved the new plan, Wang Baodong, press counselor and spokesperson for the Chinese Embassy in Washington, expressed receptivity to the proposal.
“China is always ready to be engaged in enhancing dialogue and cooperation with the U.S. in dealing with product quality and food safety,” Baodong said by e-mail. “Such communication and cooperation are beneficial to both sides.”
The establishment of FDA offices in China is not the agency’s first attempt to prevent substandard exports from reaching the United States. Each year the organization conducts roughly 1,000 inspections of foreign facilities, provides training for its regulatory counterparts abroad, and advocates for higher international food and product safety standards. The agency has also negotiated more than 50 Memoranda of Understanding (MOUs), which require foreign exporters to ensure that their U.S.-bound products meet FDA standards before they are shipped.
Despite these precautions, products coming from China continued to pose health and safety risks to U.S. consumers throughout 2007. Last March, the FDA warned pet owners to avoid pet food produced by Menu Foods, Inc. after the Canadian manufacturer found contaminated wheat gluten in several of its products. The gluten, which was imported from China, was believed to contain melamine, a chemical commonly used in fertilizers and fire retardants. Hundreds of pets died of kidney failure after eating the tainted food.
In May the FDA announced the recall of a Chinese product labeled as monkfish, which was believed to contain tetrodotoxin—a harmful neurotoxin that cannot be removed by cooking or freezing. And in October, the agency cautioned consumers to avoid purchasing toothpaste labeled “Made in China” after several countries, including Panama, found traces of a poisonous chemical called diethylene glycol in toothpastes and cough syrups traced back to the Asian nation. Many non-food products were recalled as well because they threatened consumer safety; including toy trains, baby carriers, air pumps, fans, electric heaters, computer batteries and other products.
“China attached great importance to the defect[ive] products exported overseas, and [has] taken resolute actions to improve the quality and safety of its exports, particularly toys, food and drugs,” Baodong said.
Last April, China executed a former head of its food and drug regulatory agency after he was found guilty of accepting bribes to approve an unsafe antibiotic, which resulted in at least 10 deaths.
Last year’s massive recalls prompted FDA officials to refocus their domestic inspection efforts on a variety of Chinese products, as they arrive at more than 150 U.S. ports of entry each day. Since March 2007, the agency has refused nearly 1,900 shipments originating in China, more than any other country. India and Mexico followed in the number of shipments rejected, with 1,800 and 1,780 respectively, according to information gathered from the FDA’s Web site.
But the number of products refused by U.S. inspectors comprises only a fraction of the large quantity of goods that China exports to the United States each year, according to Baodong.
“Generally speaking, China’s exports to the U.S. have been enjoying [a] very high rate of qualification,” he said. “Over 99 percent of all the exports to the U.S. were up to the standard for the last three years.”
Experts say the reason China continues to top the FDA’s refusal list is the rapid rate at which its manufacturing industry has grown in recent years. According to the latest WTO report, the country’s exports grew by 27 percent in 2006, compared to the United States’ 15 percent growth rate. By the year’s end, China replaced the United States as the world’s second leading exporter behind Germany, which it is also expected to surpass in 2008.
“China is becoming a major player on the market in a very quick and rapid fashion without the chance to gradually work their way up to that place,” Waldrop said.
The country’s decentralized government also poses a challenge to the effective enforcement of food and product safety standards. Waldrop said it is common for regional and city government officials to interpret regulations differently and to implement standards in different ways.
“All these different levels of government bureaucracy make it more difficult to oversee the entire country,” Waldrop said.
In December of 2007, after six months of negotiations, China signed a memorandum of understanding requiring manufacturers to register with Chinese authorities. According to the U.S. Department of Health and Human Services, the agreement would also increase information sharing, quality-assurance and tracking of all exports. The memorandum, along with an increased FDA presence in abroad and a number of new bills targeting import safety, may signal a significant breakthrough in managing the growing flood of Chinese imports and restoring consumer confidence.
“I believe that positive results will be achieved through bilateral consultations on an equal footing,” Baodong said

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