New Rules Would Protect GM Seed Makers From Crop Contamination Suits

by Stephen Leahy

(IPS) -- Proposed rules for experimental genetically engineered (GE) crops will allow contamination of the U.S. food supply, critics said this week, as a new poll reported Americans want stricter regulation of GE foods.

The U.S. Food and Drug Administration (FDA) released a "draft guidance document" Nov. 24 that acknowledges experimental GE crops (also known as genetically modified or GM crops) that have not been approved for human consumption could cross-pollinate or mingle with food crops.

Under the proposed guidelines companies are "encouraged" to submit to the FDA their safety evaluation of a new protein "prior to the time you have concerns that (it) could enter the food supply," which critics interpret to mean that by advising beforehand, firms will escape legal liability for any contamination.

The guidelines, which now face a 60-day public comment period, do not mention amounts, thresholds or concentration levels.

According to an FDA statement, the potential risk from new proteins is limited to their being an allergen or toxin. But, "The government is allowing the contamination of our food supply with experimental material they haven't tested," says Bill Freese, a research analyst for Friends of the Earth, U.S.

"What these rules really do is allow companies to dodge any legal liability for contamination," Freese told IPS.

Such contamination has happened in the past and cost biotech companies more than one billion U.S. dollars.

In 2000, a GE corn variety called StarLink, which had not been approved for human consumption, contaminated the U.S. food supply and its food exports. Traces of StarLink continued to be detected in food shipments to Bolivia, Japan and South Korea as recently as the fall of 2003, Freese said.

In 2002, an experimental GE corn containing a pharmaceutical (one of the so-called new "pharma crops" being developed) sprouted unassisted in a field of soy one year after the trial crop had been harvested. The company involved, ProdiGene Inc, was forced to pay millions in damages and a 250,000-dollar fine even though the "pharma" corn never reached the food supply.

Nearly 70 percent of the world's GE crops are planted in the United States, where the biotechnology industry earns nearly 40 billion dollars annually, according to the Biotechnology Industry Organization (BIO).

BIO Vice President Michael Phillips said the FDA proposal will increase regulation on the industry and improve safety, according to a report in the 'Omaha (Nebraska) World-Herald.' "It's an extra safety precaution," Phillips said.

He also acknowledged the new rules would help companies escape liability for contamination, according to the newspaper.

Experimental GE crops are currently grown on at least 23,000 hectares in the United States, according to the FOE. Monsanto, Dupont and a few other multinational companies currently hold 1,017 permits to field test crops engineered for herbicide or insect resistance, altered nutritional properties, anti-fungal compounds or sterile pollen or seeds.

"The anti-fungal crops appear to have proteins that are the type that can cause allergies," said Freese.

It is difficult to know exactly what experimental crops are being planted because almost half of them are labelled as confidential, he says.

Following the StarLink incident, the White House issued a directive through its Office of Science and Technology Policy in August 2002 to the FDA, the U.S. Department of Agriculture and the Environmental Protection Agency (EPA) to develop rules where contamination by experimental crops "could be found acceptable."

The FDA is the first to propose such rules, in part because it expects the volume of biotech field tests to grow.

The Europeans are outraged by all this, says Freese.

Europe has led opposition to GE crops and import of genetically modified foods, putting in place a de facto moratorium in 1999. The administration of U.S. President George W Bush has challenged that ban at the World Trade Organization (WTO).

"Because of the secrecy behind experiments in the United States, no one -- not food companies, not even governments -- will be able to test food products or food imports for contamination because they won't know what to test for," said Adrian Bebb of Friends of the Earth Europe, in a statement.

"This will leave consumers worldwide exposed to new risks from genetically modified foods."

But the U.S. public does not want to take risks with its food. About 85 percent of consumers questioned in an independent poll released Nov. 24 strongly believe regulators should ensure biotech foods are safe before they come to market.

About 40 percent also say there is too little regulation of GE foods. The poll was conducted by the Washington-based Pew Initiative for Food and Biotechnology, a non-profit group that studies GE food and biotechnology in agriculture.

According to an expert familiar with the poll, Americans have tremendous faith in their regulators, but wrongly believe GE foods have been approved and tested by the FDA.

"They're under the false impression there is thorough testing like there are for drugs," said the expert, asking to be unnamed.

When people learned that GE foods are not tested, they were very uncomfortable and indicated they want mandatory, uniform testing and evaluation of GE foods, noted the expert.

Indeed, 81 percent of those surveyed by Pew believed the FDA should approve the safety of GE foods before they come to market, even if that would mean "substantial delays."

"We need mandatory safety testing for all genetically engineered crops coming to market and not FDA actions allowing companies to contaminate our food supply with unknown genetically-engineered test products," says Joseph Mendelson, legal director of the Centre for Food Safety, a Washington, DC-based non-governmental organization (NGO).

"The government is admitting that genetically-engineered field test sites are polluting our food supply and environment, yet it consistently exempts these field tests from full environmental review," he added in a statement.

"We need the agencies to prevent pollution not find new ways to make it okay," said Mendelson.