Biopharming Controversy Grows Despite New Rules

By J.R. Pegg

WASHINGTON, DC, March 7, 2003 (ENS) - The federal government will allow American farmers to continue field tests of genetically modified crops engineered to produce medicinal and industrial products, the lead official at the Animal and Plant Health Inspection Service (APHIS) said Thursday.

New rules announced by the agency tighten the regulatory framework for these plants, often called biopharm crops, and "reflect the latest science and information," according to APHIS Administrator Bobby Accord. APHIS is an agency within the U.S. Department of Agriculture (USDA).

The new rules have done little to silence a growing wave of concern from environmentalists, public health advocates and food industry groups who fear biopharm crops could contaminate food crops growing in nearby fields.

"USDA's new regulations are too weak,"' said Richard Caplan, environmental advocate for the Public Interest Research Group. "By allowing pharmaceuticals to be grown in food crops, it is just a matter of time before another mistake happens and contamination occurs again." corn

The one mile buffer for biopharm corn is not enough, critics contend. (Photo courtesy Monsanto)
The possibility of contamination became a reality last November when biopharm corn grown by ProdiGene contaminated some 500,000 bushels of soybeans grown in Nebraska.

The corn was genetically modified to produce a protein that serves as a pig vaccine. The soybeans were grown in a field that had previously been used by ProdiGene to grow the engineered corn. When the corn crop failed, ProdiGene plowed it under and planted food grade soybeans.

The soybeans were intercepted before they could reach the human or animal food supply, and USDA officials said this demonstrates that adequate safeguards are in place. But others are less than convinced.

In December 2002, a coalition of consumer, environmental and farm organizations filed a legal petition calling on the USDA to prohibit open air cultivation of biopharm crops.

On Wednesday, these groups announced their intent to sue USDA to halt the planting of biopharm crops, citing the agency's "gross violations of law" for allowing the field testing of biopharm crops without performing the required environmental safety studies.

The environmental and human health risks associated with biopharm crops are "substantial," said Peter Jenkins, senior staff attorney for the Center for Food Safety, one of the 11 organizations party to the suit.

But the health benefits and economic potential of biopharm crops are hard to ignore and multinationals including Monsanto and Dow Chemical are aggressively researching them. New treatments for arthritis, herpes, cancer and infectious diseases could be manufactured through biopharming at reduced costs and greater capacity than current methods. greenhouse

A coalition of public interest groups is suing USDA prohibit open air cultivation of biopharm crops. (Photo courtesy Monsanto)
According to the USDA, 34 field tests were approved last year, covering some 130 acres in Nebraska, Iowa, California, Kentucky, Virginia, and Hawaii. No pharmaceutical crops have been approved for commercial use.

The new APHIS rules will be applied to the 2003 growing season. They include increased inspections, a new compliance training program and an increase in the size of the fallow zone surrounding biopharm crops from 25 to 50 feet.

Food and feed crops can not be grown on the same land the following year and farmers will be required to use dedicated equipment for planting and harvesting and dedicated storage facilities.

APHIS has revised specific permit conditions for biopharm corn, including a requirement that no corn be grown within a mile of a field test site where open pollinated corn is planted.

Equipment cleaning procedures and seed cleaning and drying procedures must be submitted and approved by APHIS.

"These new conditions are science based and reflect the anticipated increase of requests for permits for plants genetically engineered to produce pharmaceutical and industrial compounds," said Accord.

Although most American agricultural and food industry groups support crops genetically modified to reduce pesticide use or increase yields, they are far from convinced the proper regulatory framework exists for biopharm crops. tobacco

Some would like to see biopharming occur in non-food crops, such as tobacco. (Photo courtesy U.S. Department of Agriculture)
The changes are a small first step, says a spokeswoman for the Grocery Manufactures of America (GMA), but do not go far enough to "alleviate the concerns of the food industry."

"Regulatory changes should be implemented before new permits are issued," said Mary Sophos, senior vice president of government affairs for GMA, the world's largest association of food, beverage and consumer product companies. "There is no room for trial and error in [biopharm] regulations."

Critics contend the agency does not have the staff or resources to carry out the increased inspections it now requires and believe biopharming should be kept indoors until the risks of contamination are more fully understood.

"Any USDA policy that continues to allow open air field trials of biopharm crops is endangering the U.S. food supply with contamination," said Larry Bohlen, director of health and environment programs for Friends of the Earth.

The new rules will be published in the Federal Register on March 10 and can be seen by clicking here.