C&EN: COVER STORY - AGBIOTECH - ProdiGene And StarLink Incidents Provide Ammunition To Critics

T he ProdiGene and StarLink corn episodes have given critics of agricultural biotechnology ammunition in their calls for labeling and traceability.

Last October, regulators found a small amount of "volunteer" corn that was not supposed to be growing in a Nebraska soybean field. The volunteer corn had sprouted from seeds left over from a field trial of pharm corn--used for the production of pharmaceuticals--conducted the previous year. Last September, the U.S. Department of Agriculture had found a small amount of the same type of pharm corn in 155 acres of corn surrounding a ProdiGene test site in Iowa. In both cases, the corn was being grown under contract by ProdiGene to produce a pig vaccine.

As a result of these two incidents, about 500,000 bushels of soybeans and 155 acres of corn plants had to be destroyed. Although a minuscule amount of volunteer pharm corn would have posed no real danger to the food supply, the Food & Drug Administration considers the presence of any unapproved substance, such as a pharm crop, an illegal adulterant that must be removed from the food chain.

Following these two incidents, USDA and FDA put stronger regulations in place to keep pharm crops out of food. And the Biotechnology Industry Organization (BIO) announced a voluntary moratorium in which its member companies agreed not to grow pharm crops derived from food crops in major food-producing areas. BIO includes among its members most of the companies that are conducting field trials of pharm crops.

In 2000, another accident involved StarLink corn. The Environmental Protection Agency had approved StarLink as an animal feed and for industrial uses, but not for human consumption. StarLink contains an insecticidal protein, Cry9C, that could be a human allergen. In late 2000, StarLink corn was found in more than 300 corn products. These were recalled at a cost of tens of millions of dollars (C&EN, Nov. 25, 2002,page 6, and Dec. 11, 2000, page 10).

The StarLink and ProdiGene incidents prompted renewed calls for a halt to all pharm field trials and for labeling of biotech crops from Greenpeace, the Union of Concerned Scientists, and Friends of the Earth. These groups say that labeling and traceability regulations in the U.S. would help prevent such accidents and detect them sooner if a contamination incident does occur.

"The Europeans with their labeling and traceability legislation are far ahead of the U.S.," says Bill Freese, policy analyst at Friends of the Earth. "The U.S. food industry seems to be realizing that pharm plants pose threats, and hopefully they will put their weight behind effective segregation systems."

The ProdiGene incident "is a perfect example of how the regulatory system does work," says Michael J. Phillips, executive director for food and agriculture at BIO. The company ProdiGene "has a compliance issue. It did not follow the rules of the game that are laid out, and when you do not follow the rules of the game, you pay a huge penalty."