In a toughly worded decision released last week, a judge with the U.S. District Court in Hawaii concluded that the USDA's Animal and Plant Health Inspection Service, which grants permits for the planting of genetically engineered crops, should have first investigated whether the plants posed a threat to any endangered species.

The corn and sugar-cane plants, already harvested because the experiments involving them were completed before the case was decided, had been modified to produce human hormones, drugs and ingredients for vaccines against AIDS and hepatitis B.

"APHIS's utter disregard for this simple investigation requirement, especially given the extraordinary number of endangered and threatened plants and animals in Hawaii, constitutes an unequivocal violation of a clear congressional mandate," Judge J. Michael Seabright wrote.

The ruling is the first by a federal court on the practice of "bio-pharming," in which crops are engineered to produce potentially therapeutic human proteins. But it is not the first damning federal critique of APHIS's oversight. A December 2005 audit by the USDA's inspector general found multiple failings in the agency's enforcement of research rules for gene-altered plants.

APHIS spokeswoman Rachel Iadicicco said Tuesday that the agency had already corrected the major problems cited in the 2005 report and had recently made policy changes to satisfy the court's concerns as well.

But opponents said they have heard such assurances before.

"We are asking the judge to enjoin the issuance of any biopharma permits anywhere in the country unless and until APHIS completes a programmatic analysis of their regulatory program," said Paul Achitoff, managing attorney for Earthjustice in Honolulu, which litigated the case with the Washington-based Center for Food Safety.

The judge has scheduled a hearing for Tuesday to decide what remedies to impose.

The court ruling is the latest in a decadelong struggle that has pitted biotech companies against an uneasy coalition of environmentalists and conventional food producers and distributors.

Advocates believe that some drugs and vaccines may be produced more economically in crops than in the laboratory cultures commonly used today. Some even envision "edible vaccines," such as bananas laden with proteins that would boost blood levels of protective antibodies — an attractive strategy for developing countries, where the refrigeration needed for many conventional vaccines is not reliably available.

But opponents fear that ordinary crops may become contaminated with drug-spiked versions grown in open fields, and that unwanted drug exposures from foods could trigger allergic reactions or other problems in people or animals.

The federal court's decision responds to a 2003 lawsuit by several public-interest groups. Taking a novel tack, the groups accused APHIS of failing to consider the potential impacts on endangered species when it approved four Hawaii field studies in the previous three years. The plants were produced by ProdiGene, Monsanto, the Hawaii Agriculture Research Center and Garst Seed of Slater, Iowa.

The plaintiffs — including Friends of the Earth, Pesticide Action Network and Kahea, a Hawaiian environmental alliance — noted that Hawaii is home to 329 endangered or threatened species, including many birds with easy access to test plots.

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