CSPI on Possible Permit Violations by ProdiGene

Statement of CSPI Biotechnology Project Director Gregory Jaffe

November 15, 2002

The permit violations by ProdiGene, Inc., as well as the permit violations Environmental Protection Agency uncovered earlier this year for genetically engineered crops grown in Hawaii, provide ample evidence that the biotechnology industry cannot be trusted to meet its obligations of safeguarding the food supply and environment. The new infractions are especially troublesome because the unapproved crops made it so close to entering the food chain.

To prevent future violations, the federal government needs to put in place a robust inspection and enforcement program that ensures that permit conditions are adhered to. This time USDA’s inspection program was able to catch ProdiGene’s violations before unapproved corn entered the food supply, but it is unknown whether similar violations have gone undetected.

If the biotechnology industry continues on its path of producing pharmaceuticals and industrial chemicals in food crops such as corn and canola, the Food and Drug Administration should have a mandatory premarket food-safety approval process before those crops can be grown in the field. That would ensure that no person will be exposed, even inadvertently, to any harmful substances if permit conditions are violated or containment is less than 100 percent.

In addition, USDA needs to increase the transparency of its regulatory process and enforcement activities. The alleged violations occurred weeks ago, yet the public has still not been adequately informed about the nature of those violations or the actions taken by the government to contain problems resulting from those violations.

The enormous promise of agricultural biotechnology will not be realized unless robust and sensible regulatory systems ensure the safety of products in an open and transparent manner. The message to consumers from the ProdiGene problem is that the current regulatory system is far from achieving that goal.


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