International Food Safety : A Codex Consensus, The Biotech Dilemma

by Food and Drug Administration (FDA)

(Page 2 of 3)

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.

About the Author

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