Nature Biotechnology 21, 3 - 4 (2003)

Puzzling industry response to ProdiGene fiasco

Jeffrey L. Fox1

  1. Washington, DC

Puzzling industry response to ProdiGene fiasco

© Corbis Images

Food producers are calling for stronger regulations that will keep pharmaceutical crops not meant for human consumption entirely separate from the food supply.

In December, officials from the US Department of Agriculture (USDA; Washington, DC), working with the Food and Drug Administration (FDA; Rockville, MD), imposed a $250,000 fine against ProdiGene (College Park, TX) for violations of the Plant Protection Act. Meanwhile, the US Biotechnology Industry Organization (Washington, DC) caved in to intense political pressure and revised a previous statement calling for outcrossing biopharmaceutical crops not to be planted in the US corn belt. These awkward developments come at a delicate moment for companies working to develop plants that produce pharmaceutical or industrial products.

Federal officials are penalizing ProdiGene for two similar incidents involving its test plots of GM corn being raised under contract by local growers, one farm in Nebraska and another in Iowa. In the Nebraska case, officials realized that some 500,000 bushels of harvested soybeans were contaminated with small amounts of GM corn, which had been grown during 2001 on the same plot, because the farmer did not weed "volunteer" plants from the field in which the soy was grown. In Iowa, federal officials required a local producer to destroy some 155 acres of corn because it could have been cross-pollinated by ProdiGene's engineered corn being raised in a nearby field.

Without admitting to those violations, ProdiGene agreed to post a $1 million bond and also to reimburse the USDA for the costs, which could be several million dollars, involved in disposing of the contaminated crops. "We have learned some valuable lessons," says Anthony Laos, the company's president and chief executive officer. "We expect the enhanced compliance program we are developing in close cooperation with USDA to set the benchmark for regulating the entire industry."

"We have to ensure enforcement of biotech regulations in order to maintain confidence in the systems and the new technologies," says USDA Secretary Ann Veneman. "And so, when companies don't adhere to those rules, we will take action as we did ... with...ProdiGene. We are continuing to work very closely with FDA to ensure regulatory requirements are clear and that monitoring of licensees that are issued is effective and efficient.... We also don't want to stifle growth, but we have to have strong and credible regulatory systems."

Shortly before the US midterm elections BIO and several member companies announced support for strong regulatory oversight for biopharming and agreed to voluntary safeguards intended to keep such bioengineered plants apart from the food supply. BIO emphasized that, in this early phase of the development of biopharming, member companies would be better off by voluntarily refraining from growing test plots of, for instance, engineered corn plants in the corn belt.

However, relentless political heat, particularly from Senator Charles Grassley (R-IA), led BIO to retreat from this position by early December. In a letter to Sen. Grassley, BIO president Carl Feldbaum agreed that its "position statement...requires revision in order to more accurately and clearly express our views on stewardship of plants that produce pharmaceutical and industrial products." In backing away from its earlier call to limit growth of experimental crops in "major areas of production of that crop's food/feed counterparts," BIO now is saying that it will "encourage and invite alternative approaches...that would deliver at least equivalent assurances for the integrity of the food supply and export markets."

"Iowa producers have a strong, scientific case for being involved in this new agricultural opportunity," says Sen. Grassley, who envisions biotechnology becoming a multimillion dollar industry in his state. "It's good to see that BIO has realized that they are putting unscientific restraints on Iowa and many other states."

However, while Sen. Grassley and other politicians are pressuring the biotechnology industry to stay active locally, many food producers are sounding a different message about biopharming. For example, officials of the Grocery Manufacturers of America (GMA; Washington, DC) are urging USDA to mandate the use of "non-food crops" in biopharming R&D efforts.

Similarly, John R. Cady, CEO and president of the National Food Processors Association (Washington, DC), referring to the ProdiGene episode, calls it "nothing short of alarming to know that at the earliest stages of the development of crops for plant-made pharmaceuticals, the most basic preventive measures were not faithfully observed. This apparent violation of rules...very nearly placed the integrity of the food supply in jeopardy."

Last November the GMA and representatives from member companies met with Secretary Veneman and other USDA officials. Participants discussed using non-food crops and several other options for strengthening USDA regulations such as dedicating fields for growing of experimental biopharm plants only, specifying periods during which such fields lie fallow, and marking experimental crops.

"In our meeting with Secretary Veneman and her staff, GMA expressed its concerns about the possible adulteration of the US food supply and the need for strong bio-pharmaceutical regulations," says Manly Molpus, CEO and president of the GMA. "While GMA and its member companies are supportive of biotechnology's current and future benefits, we must have stronger regulations that will keep pharmaceutical crops not meant for human consumption entirely separate from the US food supply."

Some activist groups are calling for still stronger actions. For instance, the Genetic Engineering FoodAlert (Washington, DC), a coalition of health, consumer, and environmental groups, announced in November plans to petition the USDA for an "immediate halt to all biopharms." Its members also are criticizing federal officials for "not revealing pertinent information on the contamination incidents" involving ProdiGene's experimental plots in Iowa and Nebraska.

"We warned the USDA earlier this year this was going to happen," says Larry Bohlen of Friends of the Earth (Washington, DC), a member of the coalition. "If the USDA continues to allow biopharm food crops to be planted, someone is going to get prescription drugs or industrial chemicals in their corn flakes."