Shielded by a federal process that limits public access to data, biotechnology companies are quietly pushing to splice more human genes into food crops after the practice was nearly abandoned last year, a Washington-based advocacy group said in a report released Wednesday.
The report comes some 18 months after Prodigene Inc. caused an uproar by accidentally mixing such crops with conventionally grown plants in Nebraska. At the time, giant food manufacturers called for tighter regulation of such experiments, and biotech titan Monsanto Co. announced it was pulling out of the field.
The number of federal regulatory approvals and applications for these outdoor plantings — often called “biopharming” because the idea is to lower drug-making costs by using plants as delivery agents — have nearly doubled in the last 12 months when compared to the previous year, according to the Center for Science in the Public Interest.
“The biopharming industry seems to be back in business,” the group concludes in the report, which was based on publicly available U.S. Department of Agriculture data.
Prodigene biopharming corn again
In fact, Prodigene is again growing genetically engineered corn in Nebraska after the USDA approved a “pharmaceutical application” from the company in April.
John Reiher, the company’s chief executive since August, would not say what was being spliced into the corn, how many acres were under cultivation or where exactly it was growing.
Other companies with similar applications approved this year include Hayward, Calif.-based Planet Biotechnology and Ventria BioScience of Sacramento.
The USDA has approved seven of the 16 applications it received between May 2003 and April, with the nine pending applications all submitted in the last four months, the report says. Its author, Greg Jaffe, says the USDA has denied only two such applications since 2000.
Since 1995, the USDA has approved slightly more than 300 biopharming plantings throughout the country. As late as June 2002, it approved about 25 annually before approvals fell.
No human drug made from genetically engineered crops has been approved for commercial use and most applications are for small outdoor plots of less than acre each, the USDA said.
Traditional farmers left in dark
Still, Jaffe and other critics complain that current USDA regulations are too lax and not open enough to the public.
Most applications, for instance, don’t specify how many acres are to be cultivated and exactly where the pharmaceutical crops are to be grown, making it impossible for conventional farmers to know whether biotech varieties that could cross-pollinate with their harvest are growing nearby.
Behind the new plantings are small biotechnology companies and university researchers who seek to create inexpensive human medicines such as insulin and vaccines by splicing protein-producing human genes into crops that include corn, rice and even tobacco.
The human genes coax the crops to produce proteins, which can be extracted from the plants and turned into medicines.
At Stanford University, 16 lymphoma patients last year were treated with an experimental cancer drug extracted from a genetically engineered tobacco created by Large Scale Biology Corp. — the first human use of a pharmaceutical derived from a plant.
This biotechnology niche had been growing steadily for a decade despite continued attacks from genetic engineering foes who fear such work has not been studied enough to ensure the safety of the nation’s food supply if accidental mixing occurs.
Biopharming suffered a dramatic setback in late 2002 when the USDA fined Prodigene $500,000 and ordered it to pay another $3 million to buy and destroy conventionally grown soy contaminated with corn it had genetically engineered to produce a pig vaccine.
The Grocery Manufactures of America, which supports biotech crops approved for consumption and represents the Coca Cola Co., Nestle and dozens of others in the $500 billion food industry, has called on the USDA to tighten regulation of biopharmed crops and biotech companies to experiment exclusively with non-food crops.
In April, California regulators denied Ventria’s application to grow rice with human genes after California rice growers said they feared international customers would refuse to buy their conventionally grown crops out of contamination fears.
More info to be public
In response to the growing concern, the USDA plans to unveil a revised review process in the next three weeks that would make public more information on pharma applications and, for the first time since 1998, require detailed environmental assessments on large-scale projects near commercialization, said Cindy Smith, the deputy administrator of biotech regulation for the department.
Smith said the USDA would begin releasing the size of the field test and the risk assessment on the environment for each application. In addition, the public would have 30 days to comment when the agency does a more in-depth report on the crop’s impact on the environment before a permit is issued.
“Our regulatory system now offers those safeguards” to protect human health and the environment, said Smith. “I think the difference is the safeguards we have in place will soon be more transparent to the public and that will allow the public greater confidence in our regulatory system.”
Smith said Prodigene will be the first company to undergo the more stringent environmental review on the two applications it has pending to grow pharmaceutical corn in Texas this year.
The center's report is online at www.cspinet.org/new/200406021.html.