US growers of genetically-modified crops used to produce pharmaceutical and industrial compounds will face stricter requirements to obtain permits for field tests beginning this year, the Department of Agriculture (USDA) announced March 6. The new restrictions are an attempt to ensure that genetically-engineered crops grown for non-food purposes don't contaminate fields used to grow food crops.

"One of the things that we're anticipating is more requests for permits of this nature and a scale-up for commercialization of these projects," said Rebecca Bech, acting regulatory director for biotech regulatory services with USDA's Animal and Plant Health Inspection Service (APHIS). "Our focus is to ensure the integrity of the regulatory system and the safe field testing."

The tighter restrictions were unveiled just two days after 11 environmental and consumer groups issued a 60-day notice that they would bring suit against USDA if it doesn't at least temporarily halt the planting of genetically modified crops destined for use in pharmaceuticals and industrial compounds.

US regulators have not yet approved any pharmaceutical crops for commercial use. But past incidents of potential food-crop contamination involving test fields belonging to ProdiGene, increased concern for the food supply among consumer groups.

"It's certainly not enough," said Peter Jenkins, attorney and policy analyst for the Center for Food Safety in Washington, DC, of the new test-field permit requirements. The group, which is among those that threatened suit, wants genetically engineered crops to be grown only in confined spaces such as greenhouses and for only non-food crops, such as tobacco, to be used to produce pharmaceutical and other compounds. "There are very few ways to safeguard this stuff once it gets out there broadly," Jenkins said.

In addition to requiring a one-mile buffer zone around biopharming fields, USDA will now demand that dedicated equipment and facilities for planting, harvesting and storage be used for the GM crops. The agency will also be overseeing training for personnel to ensure that permit requirements are understood and enforced, and will be significantly increasing its inspections of every test site, which averaged one per year in the past. Under the new requirements, USDA intends to make as many as five site visits during the growing season and two visits the following year to assess the presence of volunteer plants.

Environmentalists are also calling the new permit requirements inadequate. "The best-designed system is not flawless," said Larry Bohlen, director of health and environmental policy at Friends of the Earth, Washington, DC, another of the groups which threatened to sue USDA. "When USDA promises there will be no contamination by pharmaceutical food crops, inevitably there will be."

"As a fallback, [USDA] could have imposed some geographic restrictions to make sure it was not planted anywhere near food crops, but they didn't do that because of political pressure," Jenkins said.

Members of the Biotechnology Industry Organization (BIO) did propose last year to observe a voluntary ban on growing GM crops in US breadbasket states, but pressure from those states forced the trade group to abandon its attempt at self-regulation.

Members of the industry trade group seem to be taking the new USDA-imposed restrictions in stride. "We're certainly very supportive of these modifications," said BIO spokeswoman Lisa Dry. Because pharmaceutical production in plants is such a young industry, Dry said, "It's very important we have a rigorous system in place to produce new pharmaceuticals that can give patients faster access to life-saving drugs."

Even smaller biotech companies say they're on board. "It's a positive path toward enforcement and control, which we strongly support," said Debra Robertson, executive director of intellectual property at Epicyte, a San Diego, Calif., company that uses plants to produce antibodies.

Neither USDA nor industry stakeholders would estimate the costs of the new restrictions, but biotechs seem ready to reach into their wallets. "What we have to do to meet those standards is a part of the cost of doing business," Robertson said.

"Anything that comes across as a move toward regulation will be a step toward getting investment in plant-derived pharmaceuticals," added Charles Arntzen, distinguished professor of plant biology at Arizona State University, and emeritus president/CEO of the Boyce Thompson Institute for Plant Research.

The USDA announcement, published in the Federal Register today, includes a request for comments about further safeguards the agency can undertake. USDA plans to publish an interim final rule that will require a permit for field testing for the 2003 growing season, but has not set a date, according to a spokeswoman.