A small biotechnology company that mishandled gene-altered corn 11/2 years ago by allowing it to possibly mix with food crops has applied for four new permits to grow experimental plants that could one day yield medicine, according to a new report by a consumer group.
The company, ProdiGene Inc. of College Station, Tex., has already received approval from the U.S. Department of Agriculture for one permit, which involves growing gene-altered corn in Nebraska. The company's applications are among the 16 that have been filed in the past year, marking the resurgence of an industry attempting to turn ordinary plants such as corn and rice into factories for drugs and industrial chemicals, says the report by the Center for Science in the Public Interest.
The center supports the new technology, called "biopharming," in principle, but has called for stricter regulatory oversight by the USDA. With the technique, crops used for food can be bred instead to produce special proteins for pharmaceuticals or other compounds. Biotechnology companies say the cutting-edge approach could prove less expensive than conventional means, and that could make certain drugs more accessible to the public.
But the strategy has come under intense scrutiny since November 2002, when the USDA alleged that ProdiGene had failed to take the necessary steps to keep gene-altered corn separate from nearby food crops in Nebraska and Iowa. The company was later fined, and it agreed to pay to destroy about 500,000 bushels of soybeans that may have been contaminated with the pharmaceutical corn.
Company officials said they have since put in place stringent safeguards to ensure a similar mishap does not occur.
The 2002 episode led to a drop-off in applications to the USDA for permits to grow the special crops. But according to today's report, the hiatus has recently ended and applications are once again on the rise.
The center's new report, "Sowing Secrecy: The Biotech Industry, USDA and America's Secret Pharm Belt," says the USDA has approved seven of the 16 applications received for permits to conduct biopharming within the past year. The other nine are pending.
During the year that included the growing season immediately after the ProdiGene incident, only four applications were approved. In the year before the incident, the USDA issued 25 permits.
The report also shows that of the 16 applications from the past year, about two-thirds involved a food crop such as corn, rice or barley. Many of the gene-altered crops will be grown in states where those kinds of crops are cultivated for food.
"The food industry and consumer groups said after ProdiGene that we shouldn't be using food crops and if we do use food crops, we should do it very far away from where food crops are grown for food purposes," said Gregory Jaffe, the report's author and the Center for Science in the Public Interest's biotechnology project director. "But if you look at the applications, the companies don't seem to be listening."
Lisa Dry, spokeswoman for the Biotechnology Industry Organization, said companies are working with regulators to do all they can to make sure biopharming remains safe. The new report, she said, ignores the potential benefits of biopharming and the reason why new techniques are needed to develop drugs. "The conventional methods just don't meet the demand," she said.
Jaffe's organizations has long pushed for more transparency in what it sees as an opaque process for approving permits. Yesterday, the USDA said it will announce revised rules later this month that will give the public greater access to information about exactly what crops biotechnology companies are planting and how great a risk they pose.
"We believe in being transparent, and that's why we are working on our rules," said Cindy Smith, the USDA administrator who oversees regulation of biopharming.
Smith said the USDA hopes to address one of Jaffe's central criticisms by working with the Food and Drug Administration to assess the effects on humans if a gene-altered plant were to slip into the food supply. That new policy has not been finalized, however, and she said it could take several years to implement.
Scientists believe that most pharmaceutical and industrial proteins are easily digestible and are not likely to harm people, even if they're eaten in large quantities. Still, because the exact impact of any individual protein is not known, if gene-altered plants were to become mingled with ordinary crops, it could spur a massive recall.
That possibility concerns the Grocery Manufacturers of America, which represents the food and beverage industry.
"We need a comprehensive regulatory system that ensures everyone knows who is responsible for what when the products are being developed. Right now we have a piecemeal system," said Stephanie Childs, a Grocery Manufacturers of America spokeswoman.
But ProdiGene chief executive John Reiher said the USDA has already enacted a robust set of rules that allow for no margin for error. The USDA tightened its rules in March 2003, just four months after ProdiGene's mishandling of its gene-altered corn became public.
Under the revised rules, the USDA mandated extended buffer zones between ordinary crops and their gene-altered cousins, more stringent harvesting procedures and better training for farmers and biotechnology company employees involved in growing the crops. The USDA also said that biopharm companies could expect seven times more inspections by federal regulators.
"USDA has expanded its regulatory requirements since the ProdiGene incident. . . . [The new rules] would prevent a similar situation from happening again," said Reiher, whose company has three applications pending to grow gene-altered corn in Texas.
Reiher said ProdiGene is in full compliance with the new regulations, and in some cases exceeds the requirements. For instance, the new rules dictate that gene-altered corn can't be grown within a mile of ordinary corn. Reiher said his company's corn is kept two or three miles away from any corn that winds up on consumers' plates.
Scott E. Deeter, president and chief executive of California-based Ventria Bioscience, said technology and economics often don't allow for the use of crops other than food when it comes to biopharming. His company, he said, has applied to use rice and barley to develop products that could improve human health.
"We wouldn't be able to bring these benefits to society if we were relegated to a non-food system," he said.