Washington – Environmental groups Tuesday called for a moratorium on open-air tests of crops genetically engineered to produce medicines and vaccines, citing a federal court’s conclusion last week that the Agriculture Department repeatedly broke the law by allowing companies to plant such crops on hundred of acres in Hawaii.
In a decision released without fanfare late 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 that state’s hundreds of endangered species.
The corn and sugarcane 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,” wrote Judge J. Michael Seabright in his Aug. 10 decision.
The ruling is the first by a federal court on the controversial practice of bio-pharming, in which crops are engineered to produce potentially therapeutic human proteins.
It is not the first damning federal critique of APHIS’ oversight. A December 2005 audit by the USDA’s Office of Inspector General found multiple failings in the agency’s enforcement of research rules for genetically altered plants.
Seabright has scheduled a hearing next week to decide what remedies to impose.
The court ruling is the latest in a decade-long 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 that are 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.
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 reactions or other ills in humans or animals.
Fears of admixture gained credence in 2002 when a Texas company was found to have broken rules in its cultivation of corn plants engineered to make a pig- diarrhea vaccine. The error necessitated the destruction of 500,000 bushels of potentially contaminated soybeans and left the now defunct company, ProdiGene, stuck with millions of dollars in cleanup costs.



