A ruling by the European Court of Justice is raising the U.S. biotechnology industry's hopes some European regulators might take a more scientific approach to regulating the sale of genetically modified foods.
Some observers think, however, many governments will continue to keep corn, bananas and other genetically altered crops out of their markets through protectionist measures dressed up in the guise of science.
The recent ruling by the ECJ, the European Union's supreme court based in Luxembourg, stated that governments in Europe can briefly ban the sale of genetically modified foods in their domestic markets, as long as concerns over the quality and safety of the products were not "purely hypothetical or founded on mere suppositions which are not yet verified."
The case came to the ECJ after Italian regulators stopped the sale of genetically modified corn made by Monsanto Co., located in St. Louis, one of the top agricultural biotechnology firms in the United States.
"We certainly take great hope in the language that came out of the court's opinion, namely that these decisions have to be made with scientific reasoning -- and not just be hypothetical," said Peter Resnick, a partner with the pharmaceutical law practice at McDermott, Will & Emery in Boston, which has represented Monsanto.
Fears about the safety of genetically modified foods are so strong in Europe protesters in France and Spain destroyed fields of corn planted by Monsanto twice during the summer.
Former European colonies in Africa have followed the lead of regulators on the continent and banned the importation of fungus-resistant genetically modified foods, even though their domestic agriculture production has lagged due to drought or disease.
"Caution with novel technologies is quite appropriate," Resnick told United Press International. "But these technologies are not novel. They have been in use in the U.S. for years, and have been accepted in the U.K., too. In close observation, there has been no safety hazard for these foods."
Much of the concern over genetically modified foods has emerged just in recent years in the wake of health scares, like the spread of mad cow disease in Europe.
"The problems there arise out of concerns over hoof and mouth disease -- but that panic arose out of natural causes," Resnick said, and noted farmers fed body parts of infected cows to other cattle, thereby spreading the disease.
This led the British government to order herds of cattle be culled to stop the spread of the infection.
"If they had used genetically modified foods to feed their cattle, they would have avoided these problems," Resnick said.
Concerns continue to emerge in other European countries as well. The government of Austria recently tried to create a genetically modified food free zone in its country but was blocked by regulatory authorities in Brussels, capital of the European Union.
The activist group Greenpeace has an ongoing protest against genetically modified foods and has undertaken street theater protests in Vevey, Switzerland, near the headquarters of Nestle S.A. The campaign is aimed at stopping the "genetic manipulation of nature," according to the organization's Web site.
Even the Vatican is getting involved, and is expected to produce a report on genetic modification in the coming months.
Some patent lawyers and medical doctors contended the concerns are overwrought.
"Right now, there are no credible studies to show that genetically modified foods show any danger to the public," James A. Gale, a partner and patent attorney with the firm of Feldman, Gale & Weber, located in Miami, told UPI.
There are other, ulterior motives that governments in Europe have for banning genetically engineered crops, Jeff Bates, an intellectual property lawyer and partner with McDermott, Will & Emery in Boston, told UPI.
"What we're really talking here about are trade issues and issues of international law," Bates said. "There is great concern that this could turn into a covert barrier -- a pretext for a trade barrier."
Dr. Henry Miller, a medical doctor and former head of biotechnology at the U.S. Food and Drug Administration, was even more critical.
"There's a saying in Washington, D.C., and that applies in other government capitals as well," said Miller, a fellow at The Hoover Institution in Stanford, Calif. "And that is that when something has been said three times, it becomes a fact. That's what's going on here.
"They keep repeating that there are concerns about genetically modified foods, and so the concerns become the factual basis for the delay. This is ideological pandering to interest groups. They are generating fears over imaginary hazards," he said. "And that is the scandal of the last half-century. They have created major industries in the legal community and in the non-governmental organization community over these alleged hazards, over nothing."
Government regulators have invoked the "precautionary principle" through which to view the regulation of genetically modified foods, Miller said.
This principle holds that if there is any potential public health risk involved in the introduction of a new food technology to market, it is best to hold off bringing it to market until better information emerges for a more scientifically sound regulatory decision to be taken, he added.
"But that's like looking for the human soul," Miller said. "You'll never be able to be certain that it is there."
Gale, who represented the organization that created the genetically engineered sheep, Dolly, said if all human activity was undertaken through the framework of the "precautionary principle" then "society would not be able to function."
The opinion by the ECJ, though, could help reduce regulator over-reliance on this principle.
"To the extent that regulators use a test that is a fair-minded evaluation of the technology, that is fine," Resnick said. "But it has to be rational and based on a scientific method, and a process that does not result in unbounded delay."
Miller, though, is not too hopeful the issue will be resolved soon, and said governments in the United States and elsewhere are eyeing the European style of food regulation. He despairs over the starvation plaguing some nations because of the bias against genetically modified foods.
"We've even seen concerns over gene splicing in Zambia, Zimbabwe and Uganda," Miller said. "Uganda is being devastated by a banana fungus. Bananas are far and away their most abundant crop. Experimental varieties of the crop have been developed in Hawaii and Belgium. But, the Ugandan government won't allow them to be tested, because of the concerns raised in Europe. This is idiotic and gratuitous."
Miller said if regulators continue to try to keep out certain foods developed with genetic technology, companies will stop their research spending in that area because there is no potential return on the investment.
"No one will genetically improve millet or sorghum or yams or other important subsistence crops," he said. "The crops can be enhanced for pest resistance, disease resistance, and for greater nutritional value. But it's not going to be done, due to the regulatory costs and the uncertainty."