No bumper crop of genetically altered plants

"There are products that won't have biotech [added in] because of the regulatory situation," adds John Nelson, marketing manger for the US arm of Sakata Seed Corp., based in Yokohama, Japan. Sakata has adopted a company policy not to offer GMOs in any of its product lines.

The dramatic slowdown isn't due to domestic regulators, such as the US Department of Agriculture (USDA), the Environmental Protection Agency (EPA), or the Food and Drug Administration (FDA), says Val Giddings of the Biotechnology Industry Organization, a trade group based in Washington. It's regulation in the European Union (EU) and elsewhere. What's especially daunting to companies is the prospect of having to meet widely varying standards from country to country.

"If [firms are] daunted by the cost of the technology, just wait until they face the rising cost of registrations," says Ronald Meeusen, vice president of research and development at Dow AgroSciences LLC, based in Indianapolis. "USDA, EPA, FDA, up to 15 member-state regulatory agencies in the EU ... as well as the Japanese and others: Every one of them wants a dossier of studies prepared their way and presented by local experts in their native language. Many want studies repeated on their own soil."

Understandably, each nation wants to safeguard its consumers, industry insiders concede. But the extra requirements and repeated testing can add 25 percent to an already hefty bill of $30 million or more to commercialize a GMO crop.

Cost isn't the only issue. "It's logistics," says Warnick of Syngenta. The company raises its melon seed in Asia. The melons are then grown in Central America and exported to the US for consumption. If the firm genetically engineered its melon seed, it would have to get regulatory approval in at least three countries.

But such delays will help scientists gain a much better understanding of genetic changes in plants, critics of the industry say. "It's hard to read the scientific record of what's going on without being impressed by how much we don't know," says Charles Benbrook, a consultant to consumer and environmental groups and former executive director of the National Academy of Sciences' board of agriculture.

Even major biotech corporations have had to adapt. Once pushing to sell a wide variety of genetically modified crops from potatoes to sugarbeets, Monsanto Co. in St. Louis has narrowed its focus. "We're focusing on four core crops - corn, oilseeds, cotton, wheat," says Mark Buckingham, a Monsanto spokesman. Not coincidentally, those are major crops in North America, with vast acreages and profit potential.

But this go-slow, narrow-focus strategy poses risks. Market skepticism and the growing thicket of international rules mean only the largest corporations will be able to afford to commercialize a bioengineered crop.

"The future of agricultural biotech is somewhat uncertain," says Neil Harl, an agricultural economist at Iowa State University in Ames. When the fate of an industry rests in the hands of a few big players instead of many small ones, "a mistake made in decision-making is far more devastating."

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