The news comes some 18 months after College Station, Texas-based Prodigene Inc. caused an uproar by accidentally mixing such crops with conventionally grown plants in Nebraska. At the time, giant food manufacturers called for tighter regulation of such experiments, and biotech titan Monsanto Co. announced it was pulling out of the field.

The number of federal regulatory approvals and applications for these outdoor plantings — often called "biopharming" because the idea is to lower drug-making costs by using plants as delivery agents — have nearly doubled in the past 12 months when compared to the previous year, according to the Washington D.C.-based Center for Science in the Public Interest.

"The biopharming industry seems to be back in business," the group concludes in a report released last week that is based on U.S. Department of Agriculture data.

In fact, Prodigene is again growing genetically engineered corn in Nebraska after the USDA approved a "pharmaceutical application" from the company in April.

John Reiher, the company's chief executive since August, would not say what was being spliced into the corn, how many acres were under cultivation or where exactly it was growing.

Other companies with similar applications approved this year include Hayward, Calif.-based Planet Biotechnology and Ventria BioScience of Sacramento, Calif.

The USDA has approved seven of the 16 applications it received between May 2003 and April, with the nine pending applications all submitted in the past four months, the report says. Its author, Greg Jaffe, says the USDA has denied only two such applications since 2000. Since 1995, the USDA has approved slightly more than 300 biopharming plantings throughout the country. As late as June 2002, it approved about 25 annually before approvals fell.

No human drug made from genetically engineered crops has been approved for commercial use and most applications are for small outdoor plots of less than acre each, the USDA said.

Still, Jaffe and other critics complain that current USDA regulations are too lax and not open enough to the public.

Most applications, for instance, don't specify how many acres are to be cultivated and exactly where the pharmaceutical crops are to be grown, making it impossible for conventional farmers to know whether biotech varieties that could cross-pollinate with their harvest are growing nearby.

Behind the new plantings are small biotechnology companies and university researchers who seek to create inexpensive human medicines such as insulin and vaccines by splicing protein-producing human genes into crops that include corn, rice and even tobacco.

The human genes coax the crops to produce proteins, which can be extracted from the plants and turned into medicines.

At Stanford University, 16 lymphoma patients last year were treated with an experimental cancer drug extracted from a genetically engineered tobacco created by Large Scale Biology Corp. — the first human use of a pharmaceutical derived from a plant.

This biotechnology niche had been growing steadily for a decade despite continued attacks from genetic engineering foes who fear such work has not been studied enough to ensure the safety of the nation's food supply if accidental mixing occurs.

Biopharming suffered a dramatic setback in late 2002 when the USDA fined Prodigene $500,000 and ordered it to pay another $3 million to buy and destroy conventionally grown soy contaminated with corn it had genetically engineered to produce a pig vaccine.

The Grocery Manufactures of America, which supports biotech crops approved for consumption and represents the Coca Cola Co., Nestle and dozens of others in the $500 billion food industry, has called on the USDA to tighten regulation of biopharmed crops.

In April, California regulators denied Ventria's application to grow rice with human genes after rice growers said they feared international customers would refuse to buy their conventionally grown crops out of contamination fears.