Analysis Finds Fewer Biotech Crops Moving Through Regulatory System

For years, agricultural biotechnology companies and industry analysts predicted that genetic engineering would spawn a cornucopia of heartier crops, more-healthful oils, delayed-ripening fruits, and many other more nutritious and better-tasting foods. However, the number of genetically engineered (GE) crops going through the regulatory review process dropped sharply between the late 1990s and the early 2000s, according to a report issued today by the nonprofit Center for Science in the Public Interest (CSPI). Also, the federal government is taking longer to review GE crops, according to CSPI, even though most of the recent crops have been slight variations of previously approved crops.

CSPI reviewed regulatory records for GE crops at the Food and Drug Administration (FDA)and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture. CSPI found that the products reviewed in the 2000s have mostly been crops with the same or similar genes as the first generation of GE crops commercialized in the late 1990s, such as insect-resistant or herbicide- tolerant versions of soybean, corn, cotton, and canola.

“The biotech industry is quick to bemoan government regulation, claiming it is too onerous,” said Gregory Jaffe, director of biotechnology policy for CSPI and the author of the report, Withering on the Vine: Will Agricultural Biotech’s Promises Bear Fruit?. “But the fact is that even without strict government regulations, the industry is not innovating, it is stagnating. The industry promised a bounty of beneficial crops, but the biotech cupboard remains pretty bare, except for the few crops that have benefitted grain, oilseed, and cotton farmers.”

Government reviews of GE crops have slowed in the last few years. At the FDA, to which companies submit human-safety data about their GE crops voluntarily, CSPI found that from 1995 to 1999, 47 crops completed the regulatory process, with consultations taking, on average, about seven months from start to finish. From 2000 to 2004, only 15 crops completed the process—a drop-off of two-thirds. And, the FDA took almost twice as long—13.8 months on average—to complete its reviews.

APHIS focuses on whether a GE crop presents a hazard to other plants. Companies formally petition APHIS to have their GE crops given “non-regulated” status. Forty-nine such approvals were granted from 1995 and 1999, with approvals taking an average of six months from start to finish. Just 13 such approvals were granted from 2000 to 2004, and again, it took APHIS almost twice as long—13.4 months on average—to grant approvals.

“Those who believe that biotech crops hold great potential to help human health, farmers, and the environment should be concerned that few new crops are coming down the pike,” said Jaffe. “At the same time, we should work to replace the voluntary, antiquated, and inefficient hodgepodge of a regulatory system with a mandatory system that takes risk into account. Those crops expressing genes known to be safe should be expedited, freeing up government officials to focus on novel crops where the risks may be greater.”

In the report CSPI also recommends increasing public investment in GE crops, particularly by applying existing technology to non-commodity crops and by expanding research on biotech crops that would benefit consumers. CSPI also urged increased government support for research on crops that would be important to developing countries and says that the agricultural biotechnology industry should make its proprietary technology freely available for public research and development efforts. Finally, CSPI criticized the biotech industry for opposing sensible biosafety regulations in the U.S. and abroad—regulations that CSPI says would help GE crops gain greater acceptance among consumers.