THE US has tightened its regulations on plants engineered to produce drugs or chemicals. The aim is to prevent the contamination of food crops, but the new rules are not nearly tough enough, say critics.
The previous regulations came under fire (New Scientist, 6 July 2002, p 4) even before it emerged that they had been violated by a company called ProdiGene. Its maize containing a pig vaccine twice contaminated soybean crops. The furore spurred the US Department of Agriculture into action. 鈥淎s we came up with these measures, I will tell you that one of the questions we asked ourselves was would this prevent a ProdiGene event from happening,鈥� admits Cindy Smith, a biotech expert at the USDA.
Many of the changes increase the separation of pharm plants from normal crops. For example, maize producing a therapeutic protein must now be kept at least 1600 metres from maize food crops and planted 28 days before or after surrounding maize to prevent cross-pollination. Under the old rules the gap required was just 800 metres, with 21 days of temporal separation.
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For the first time, the USDA is also stipulating that companies dedicate some machinery to harvesting and planting pharm crops. To ensure compliance, inspections are being dramatically increased, from one last year to seven separate inspections for each crop for 2003 permits.
The politically powerful food industry wants pharmaceuticals to be grown in non-food crops only. It fears that another contamination incident could hit exports hard. 鈥淭here is no room for trial and error in plant-made pharmaceuticals regulations,鈥� says Mary Sophos of the Grocery Manufacturers of America. Another criticism is that companies still do not have to disclose exactly how pharm plants are modified.
The USDA is not ruling out further tightening of the rules. That may explain why few companies are rushing to get permits.