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Back To Vidyya The International Flow Of Food:

FDA Takes On Growing Responsibilities For Imported Food Safety

Mike Wehr has his bags packed. His tickets are bought, his hotel reservations confirmed, and all other necessary arrangements made. Wehr is about to leave the country, again. Last year alone he was out of the United States a half dozen times. He went to Belgium and Australia twice, and to Japan and Brazil once. In the near future, Wehr expects to go back to each of those countries once and perhaps to Hungary as well. In all, he is on the road at least 60 days a year on official U.S. government business.

Wehr's mission is simple: to help make the world's food safe to eat here in the United States regardless of where it is planted, produced or packaged. He is one of a small but growing number of Food and Drug Administration employees who work with international standards-setting institutions, multinational health and trade organizations, and government and private agencies in other countries around the world.

And it's a changing world. In the past, FDA focused most of its food safety efforts within the U.S. borders, where it has legal authority. But changes in trade, consumer demand for variety, and an increasingly complex regulatory system have created new challenges for the agency. On one hand, the FDA Modernization Act, passed in 1997, requires the agency to cooperate with other countries and international institutions. On the other, FDA often finds that U.S. standards and rules differ from those of other developed countries. Meanwhile, FDA works with developing countries to help them understand and meet U.S. standards for foods and agricultural products they export to the United States.

"It's a very different landscape for this agency than it was five or six years ago," says Wehr, one of FDA's representatives on food issues to Codex Alimentarius, an international standards-setting group based in Rome. "There has been a fundamental change in the importance [of international food safety issues to FDA]. We have to be part of the international arena. That is a new role for us. It is a role that continues to evolve every day."

New Ways To Work Together

Even at home, FDA cannot act alone on international food issues since other governmental agencies play major roles, including the U.S. Departments of Agriculture, State and Commerce, the Environmental Protection Agency, and the Office of the U.S. Trade Representative, among others. Further, all federal activities involving Codex are managed within USDA's Food Safety and Inspection Service (FSIS).

As much as anything else, consumer demand drives these changes, especially the shifts in where American companies and consumers get their food. "Food has become a global commodity," says Janice Oliver, deputy director of FDA's Center for Food Safety and Applied Nutrition (CFSAN). "We Americans have changed our eating habits. We used to eat whatever was grown locally and in season, and only one or two varieties of anything. Today, food is international. It is from Central and South America or Europe or the Asian countries or the islands of the world."

More than ever before, Americans can buy more imported foods at local grocery stores and supermarkets, adds Linda Horton, director of FDA's international agreements staff, because of improved ways of packaging and preserving food, and more rapid means of transporting it. That, she says, means American consumers "can get anything from anywhere at almost any time."

Imported Food Consumption on the RiseAccording to USDA's Economic Research Service, Americans are eating more imported foods than ever before. So much so that imports of processed foods rose 5.8 percent in 1998, the last full year for which complete records are available. The estimated value of food imports in 1998 hit $32 billion, a new U.S. record. Moreover, food imports exceeded exports in 1998 by $2.6 billion, the first U.S. agricultural trade deficit since 1991.

The numbers for individual commodities are even more striking. Sixty-two percent of all fish, fish products and shellfish eaten by Americans, for example, came from abroad in 1997. That's up from 45 percent in 1980.

Similarly, Americans ate almost half again as much fresh fruits from other countries in 1997 as in 1980, up from 24 to 34 percent. Imported fresh vegetables accounted for more than 10 percent of vegetable consumption in 1997, compared with 5.4 percent in 1980. And foreign-grown wheat totaled 10.4 percent of the American diet in 1997, up from 0.4 percent 20 years ago.

As a result, FDA is more involved in foreign trade issues now than ever, says Catherine Carnevale, director of CFSAN's office of constituent operations. To ensure that the food Americans eat is safe to consume, the agency inspects imported food and refuses entry to unsafe, adulterated or mislabeled products, using the same standards as for domestic food. Under the evolving international rules, FDA now certifies that American-made seafood and dairy products sold abroad meet the importing country's requirements and are the same products as those sold in this country.

Whatever the specific role, FDA's focus remains on safety. "We are here to protect American consumers," Carnevale says. "Our goal is to improve the safety of all foods consumed in the United States." Similar aims drive U.S. Department of Agriculture policies. "We have legislative mandates to set standards and encourage trade in food products, but safety comes first," says Catherine Woteki, USDA's undersecretary for food safety. "All agencies of the U.S. government are unanimous that a science-based health and safety policy is our paramount guiding principle. Fair trade will follow."

But neither FDA nor USDA can inspect every food package brought into the United States. " We don't have the resources to examine all imported products or to inspect most overseas production facilities," FDA's Horton says, adding, "We have very porous borders. We need to work with those who export food to the United States [to make sure it's safe leaving those countries]. Cooperating with them is one way of protecting American consumers and promoting public health worldwide."

A Codex Consensus

That brings the issue back to Codex, the object of Mike Wehr's many foreign travels. The Codex Alimentarius Commission, as it is formally known, was created in 1962. It is jointly run by two United Nations groups, the World Health Organization (WHO) and the Food and Agricultural Organization (FAO). As its name--Latin for "food code"--suggests, Codex sets international standards of identity for agricultural products and food commodities, and determines safety standards for food additives and contaminants and for veterinary drugs. By the end of 1999, Codex's 165 member-countries had agreed on maximum safe limits for 1,300 food additives, 197 pesticides and 25 contaminants. Codex had also set 204 food standards, completed 54 veterinary drug evaluations, and adopted 43 codes of practice.

Codex exists, Wehr says, because countries have long argued over agricultural trade. Most have traditionally sought to protect their farmers, growers and ranchers by a system of tariffs that imposed duties on and raised the cost of imported food. Since the signing of the General Agreement on Tariffs and Trade (GATT) in 1948, however, the world's tariffs have generally declined and even have been eliminated for many industrial and agricultural products. The creation of regional trading blocks such as the European Union (EU) and the North American Free Trade Association (NAFTA) has further lowered food duties within these groups' purview.

But, as tariffs have come down, other technical or safety issues have sometimes replaced them as barriers to free trade in agricultural and food products. The EU, for example, banned exports of beef products from Great Britain to the rest of Europe in 1996 for fear of spreading bovine spongiform encephalopathy (BSE), or "mad cow" disease. More recent concerns have included the potentially carcinogenic chemical dioxin that was found in egg products from Belgium, the use of growth-promoting hormones in animals raised for their meat in the United States, and EU rules requiring the labeling of food grown using the new techniques of genetic engineering.

Because of increasingly complicated trade negotiations arising from the creation of the World Trade Organization in 1993, Codex's role in international food safety issues "has been consciously elevated," FDA's Wehr says. From a little-known group focused on what were often seen as narrow commodity issues, he adds, overnight Codex "became the standard ... [and] its standards will be difficult to get around."

While Codex's standards are voluntary, Wehr says, "It is to our country's advantage to work with Codex and to follow its standards." Individual countries do not have to adopt them, and countries can also implement stricter standards than Codex if they can scientifically justify a higher level of protection. But countries that do not follow Codex or that lack justification for stricter food standards could lose any trade dispute over food brought before the World Trade Organization, Wehr says.

The Biotech Dilemma

Most issues that come before Codex are highly arcane and of little interest to the general public. Some, however, may directly affect not only the safety of the food that reaches the American dinner table, but also the practices of U.S. processors and growers. Food produced using modern biotechnology is a good example. American companies have pioneered methods using genetic engineering to alter a plant's genes to improve yields or provide greater resistance to insects, fungus or disease. But, since many people in Europe fear the unknown consequences of genetic engineering, the European Union has enacted rules to require labeling that identifies imported foods produced by biotechnology. Some U.S. officials fear that such rules could be used to keep American food out of European markets.

"We do not regulate food manufacturing processes unless the process matters," says Eric Flamm, an FDA senior policy advisor. "Biotechnology alone does not make a food safe or unsafe." Genetic engineering would have to introduce into plants a potentially dangerous allergen, change the nutritional content of a food, or require different handling, storage, cooking or preservation to warrant additional labeling.

On this issue, USDA policy parallels FDA's. "Biotechnology-produced foods are regulated as foods," food safety official Woteki says. "If the process introduces a significant change in the food, that change must be stated on the label." That position may be correct under U.S. law, says James Maryanski, CFSAN's biotechnology coordinator, but it leaves the United States increasingly isolated in a world apparently poised to adopt stricter regulation of biotech foods. While the number of countries that have given serious consideration to the question of labeling is still small, only a few other countries support the U.S. position.

Resolving the biotechnology debate within Codex will continue to be a complex, cumbersome, and long, drawn-out process. The issue has been before Codex since the mid-1990s. A drafting group met in India in October to prepare a document that would give countries several approaches to labeling from which to choose. The next full committee meeting is not scheduled until April 2001. "The deadlock is very frustrating," says USDA's Woteki. "We may have to change our negotiating strategy."

Toward that end, last spring FDA announced plans to strengthen premarket reviews of biotechnology-produced foods. FDA is developing a proposed new rule that will require manufacturers to notify the agency at least 120 days before they put on the market foods and animal feeds derived from genetically engineered plants. Under the new rule, once it has reviewed a company's submission, FDA will issue a letter regarding the regulatory status of the product involved. The agency will also help guide manufacturers who want to, or are required to, label their biotechnology products for foreign markets.

Learning to be Cautious

Meanwhile, biotechnology is not the only international food issue to involve FDA or to create a split between the United States and the European Union. The "precautionary principle" has similarly sparked debate among policy makers here and abroad. The precautionary principle, as defined in February 2000 by the EU Commission, would ban, require additional labeling, or otherwise restrict the use of any food if the science to determine its safety or level of risk is judged to be uncertain.

"Scientific uncertainties cannot serve as an excuse for decision-makers to do nothing," says Bernard Chevassus-au-Louis, president of the French Agency for Food Safety. "Science is not always predictive," Chevassus adds. "It is too often too late. It often underestimates the evidence for risk. The use of the precautionary principle is not a denial of science, but a call for more science."

FDA and USDA officials disagree. The precautionary principle "would require another level of risk management based on 'what ifs,'" says FDA's Carnevale. "There may not be any evidence that [a food] poses any hazard, despite the scientific uncertainty. Precaution is a part of our food safety process. It is embedded throughout our decision-making, not an add-on for politicians."

The United States is not opposed to European countries adopting the precautionary principle, Carnevale adds, so long as it is not directed solely against foods they import from the United States. Many Americans are concerned that the French could use it, she says, to restrict imported meat from cattle in the United States that were fed growth hormones, when, for example, French health agencies have so far been unwilling to apply the same principle to Listeria monocytogenes in French cheeses. The use of raw milk--which is a known source of the bacterium Listeria--to manufacture fresh and soft cheese is of particular concern to FDA. Listeriosis in pregnant women can result in miscarriage, fetal death, and severe illness or death of a newborn infant. Others at risk for severe illness or death are the elderly and those with weakened immune systems.

FDA and USDA are also concerned because the European Union has asked Codex and the Organization for Economic Cooperation and Development (OECD) to endorse the precautionary principle. OECD is an organization of the United States and other developed countries. "The European Union is doing the right thing in discussing the precautionary principle," Woteki says, "but it is premature to recommend that it be adopted for all countries. Countries with strong laws and regulations with a strong element of caution in them have no need for a precautionary principle."

Developing Safety

Unfortunately, not all countries have strong food safety rules or the resources to adopt and enforce them. Yet, for many developing countries, exporting food and agricultural products is key to their economies. Unless they can meet standards set by FDA, FSIS and EPA, however, they may have trouble exporting food to the United States. To help resolve that problem, FDA has designed programs to help developing countries understand and meet U.S. requirements. "We may not be able to get developing countries to our level [of safety]," Carnevale says, "but we can get them to a higher level."

All food imports, however, must meet FDA safety standards before they can come into the United States.

FDA sponsored multi-agency seminars in Mexico City and Santiago, Chile, in September 1999 and in New Zealand for Pacific Rim and island countries in August 2000. The effort is part of the Food Safety Initiative, a multi-agency program launched by the White House aimed at reducing the incidence of foodborne diseases. The seminars involve experts from FDA, USDA, EPA, the Centers for Disease Control and Prevention, and the State Department. Their job, CFSAN's deputy director Oliver explains, is to help government officials, food exporters, and academics in other countries understand U.S. requirements. "We tell them what we expect so they can meet our standards and keep the food we import safe," she says.

Additionally, FDA sponsored a "train-the-trainers" session, also held in Santiago, Chile, last year. That weeklong session targeted mid-level government officials, representatives of growers' associations, and others in a position to train farmers in good agricultural and food handling practices. "We hope to take elements of our safety program and adapt it to their local conditions," says Camille Brewer, CFSAN's international coordinator for the Food Safety Initiative. Additional sessions are planned for Brazil and Trinidad and Tobago.

"We are operating more and more in a complex global environment," Wehr says of FDA's continuing involvement in international food issues. "It's not clear yet how these issues will play out. But the decisions that Codex and other international institutions make will drive U.S. and FDA policies. These are big issues for FDA and for agriculture, industry and consumers."

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Editor: Susan K. Boyer, RN
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