Philip Angell, who had served as Ruckelshaus's chief of staff at the EPA, was a consultant to Perkins Coie. As a confidant of his old boss, he attended that first meeting. "Henry believed very deeply in what he was doing, and he asked us how to deal with a regulatory situation that was fraught with emotionalism," says Angell.
Ruckelshaus and Angell concluded that what Henry needed was good advice on sidestepping the political perils befalling other biotech outfits. They decided to put together a brain trust of Washington wise men.
In the annals of entrepreneurship, this may have been the most high-powered advisory panel ever assembled. Henry recruited Douglas M. Costle, who had headed the EPA in the Carter Administration. Ruckelshaus brought in Robert M. Teeter, a prominent Republican pollster who in 1988 would become co-chairman of the George Bush Presidential transition team. And he enlisted his old Justice Department boss, former attorney general Elliot L. Richardson, who has held a record number of Cabinet posts -- Defense, Commerce, and Health, Education and Welfare.
It might seem odd that a small company with no profits could attract such heavy-gauge talent, but there was a certain logic to it. Ruckelshaus, for instance, had been a director of Monsanto Co., a chemical industry giant. Richardson, for his part, was intrigued by the idea that the plant vaccine could trim the use of chemical pesticides, a leading cause of groundwater pollution, food contamination, and bird kills. (Some 1.4 billion pounds of chemicals are dumped on U.S. farms every year, twice the amount applied just 25 years ago.) Crop Genetics paid the members $1,000 for each of the formal brainstorming sessions the committee held and gave them stock options in the company.
Henry required their advice to achieve one clear strategic objective. Because his plant vaccine is designed to kill insects, it is classified as an insecticide. And he could not conduct the first, all-important field trial without an experimental-use permit from the EPA. It was absolutely critical that the company get that permit and do its test on time.
The test was scheduled for summer 1988. The company planned to conduct it on just an acre of corn at its farm on Maryland's Chesapeake Bay. A second round of tests the following summer, to be held in the Midwest, would be far more extensive. Both field trials would have to succeed before the EPA would register the product and sales could begin. Henry aimed to introduce his product in the fall of 1991 in the United States and France, Europe's largest corn producer, envisioning a market of about $100 million. He planned to market it for use on the world's three major crops: first corn, then rice and wheat.
The EPA requires pesticide tests that prove safety. In this case, the safety question centered on the difficult issue of "spread." Could the organism move from target plants to other plants?
Henry was reasonably sure they could not. After all, his biopesticidal vaccine grew inside the plant. An organism that operated inside plants was containable, at least in theory. And anyway, lab tests showed that the microbe could survive only in the sap of living plants. Outside, in soil or water, it died.
Furthermore, the biopesticide in question is a benign, naturally occurring organism called Bt that has been used for decades with no ill effects on mammals, fish, birds, or nontargeted insects. What made the new product unique -- and patentable -- was its delivery system. The company had found an obscure type of bacterium called an endophyte. Lab work showed that it could be made to multiply through cell division inside more than 80 kinds of plants, from pansies to pumpkins. By splicing a single Bt gene into this endophyte, Crop Genetics scientists could "grow" pesticides inside plants -- something nobody had ever attempted before.
Henry believed that farmers would clamor for the product. After all, chemical pesticides affect farmers more than anyone else. They contaminate the water they drink and the air they breathe. This new product promised to be safer and less expensive. And consumers would approve because it would solve the problem of pesticide residue on fruits and vegetables.
"The beauty of the system is that it requires virtually no manufacturing," says Peter Carlson, Crop Genetics' cofounder and chief scientist. "We enjoy a huge material advantage over chemical insecticides. Once our product is inside a plant, it acts like a tiny microbial factory, manufacturing pesticides around the clock. Only 20 pounds will stop the European corn borer -- our first target pest -- from damaging Iowa's 10-million-acre corn crop."
The corn borer, the nation's greatest uncontrolled corn pest, infests more than half of America's 70 million acres of corn, inflicting some $400 million in damage every year. Acting like a biological Roto-Rooter, it eats its way up and down the stalk until the plant grows so weak it simply blows over in the wind. For Crop Genetics, a vaccine for corn was to be just the beginning. But in the spring of 1986, the company's fate hinged on one thing: obtaining the EPA permit to conduct that field test. "Without that," Henry says, "we were dead meat."
There was, however, an interesting political wrinkle at work. Given the electrified atmosphere surrounding biotech, the EPA was unlikely to issue the permit without the approval of the country's main environmental groups. For Henry, the uncertainty was nerve-racking. Political risks were piling up on top of scientific risks. It was a hell of a way to have to run a business.
"The essence of our strategy was 'no surprises to anybody,' " Angell recalls. "We wanted to involve all the pertinent people as early as possible, to touch every base in sight. We wanted to contact anyone who could conceivably be interested in this experiment -- to tell them who we were and what the company was doing."
