Dec 12, 2002

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Bio-pharming: Soya harvest destroyed

Government agencies in the USA have ordered the destruction of around 13,500 tons of soya beans. The remains of genetically modified maize plants, which had previously been grown in the same field for test purposes, had been found amongst them. The maize plants are designed to produce a pharmaceutical active substance. This is the first public clash involving bio-pharming.

In mid-October 2002 an inspector from the US Department of Agriculture’s Animal and Plant Health Inspection Service (USDA/APHIS) found individual maize plants in a soya field in Nebraska during a routine inspection. They were left over from the previous year and had overwintered in the field. Although this is not unusual, in this case the authorities ordered the destruction of all the volunteer maize plants.

Trypsin maize in a soya field

These maize plants were left over from an approved cultivation trial which the biotech company ProdiGene, from College Station in Texas, had conducted there the previous year.

The biotech company was trialing maize plants that had been genetically engineered to produce trypsin, a protein found in the pancreas. Trypsin is used in the pharmaceutical industry to produce insulin, among other things. Prodigene is currently developing commercial trypsin production in transgenic maize.

When the trial ended, conventional soya for human consumption was planted on the field. The APHIS inspectors ordered ProdiGene to destroy the maize plants even if they had produced no kernels. However, this did not happen. The soya beans were harvested and stored in a silo in Nebraska. Tests revealed 65 g of maize stalks in around 13,500 tons of soya beans.

Although these small quantities do not pose a health risk, the Food and Drug Administration (FDA) nevertheless placed the silo in quarantine on 11 November and subsequently ordered the destruction of the soya beans.

ProdiGene is to pay around 2 million US dollars for the purchase and destruction of the contaminated soya beans, and has also accepted a fine of $250,000.

In future field trials, ProdiGene will have to comply with more stringent safety requirements. To this end the company and the USDA are working together to develop a suitable programme, which would be explained to the farmers involved as well. In addition Prodigene is required to deposit a $1 million bond as security.

The company came to the attention of the authorities as early as September 2002, when it was discovered that a trial field in Iowa may have contaminated neighbouring fields in 2001. At APHIS’s request, ProdiGene had to harvest and incinerate 63 hectares of maize surrounding the trial field.

Bio-pharming: Active substances in plants

The Texan biotech company ProdiGene is one of the leading companies in the cutting-edge field of bio- or molecular pharming. This involves genetically engineering crops to become “synthesis reactors” for the production of high-grade proteins, for instance drugs, vaccines, monoclonal antibodies for medical diagnostics and technical enzymes. The first of these pharmaceutical proteins produced in transgenic plants are already undergoing clinical testing.

ProdiGene plans to manufacture hepatitis B and other vaccines, pharmaceutical active substances and enzymes in transgenic maize. Since 1997, ninety three of the company’s field trials have been approved.

Strict separation. Conflict with the food industry

The conflict surrounding trypsin maize and the subsequent soya harvest in Nebraska clearly demonstrates the need for special safety measures with bio-pharming. Transgenic plants which produce pharmaceutical substances must be strictly separated from food and fodder plants. To prevent outcrossings and co-mingling, the US Department of Agriculture imposes special safety requirements on field trials with bio-pharm crops.

However, the US food industry believes that these measures are inadequate. “Trials with these plants should stop until we have systems in place to eliminate contamination 100%” a representative told the news agency Reuters. In the food industry’s view, only non-food plants such as tobacco should be used. However, maize, oilseed rape, tomatoes and potatoes are the plants of choice for many bio-pharming projects. In the meantime the biotech industry has offered to restrict the planting of bio-pharm maize to those US states, where only small amounts of maize are grown.